An SIR session titled “The Sterile Gloves Are Off” featured a heated debate on the proposition “The level of evidence linking chronic cerebrospinal venous insuffiency (CCSVI) and multiple sclerosis is inadequate and the clinical benefits of endovascular treatment are suspect”.

Jim Reekers argued for the motion and Gary Siskin against.

Reekers, professor of Interventional Radiology, University of Amsterdam Medical School, AMC, The Netherlands, began by stating that he had a commitment to “honesty, good evidence-based science and unbiased, non-commercialised medicine.” He used the historical example of Perkin’s tractors to set out his case. Reekers drew a parallel between what happened in the 18th century, when Elisha Perkins, a physician from the USA began to use metal rods to cure inflammation, rheumatism and pain in the head and the face. Perkins applied the pointed ends of the rod on the aching body part and passed them over the part for about 20 minutes. He claimed they could “draw off the noxious electrical fluid which lay at the root of suffering”.

Reekers told delegates that the Connecticut Medical Society condemned the tractors as “delusive quackery” and expelled Perkins from membership, yet he still managed to garner support from surgeons in Copenhagen and Denmark. Perkins talked about 5,000 cured cases,which were certified by professors, physicians and clergymen, noted Reekers, while criticism from other physicians was met with charges of elitism and professional arrogance. He said that in 1800 John Haygarth published a randomised, blinded study where patients derived the same effect from wooden rods.

“Have we learned anything in the last 200 years?,” asked Reekers. “Again criticism from physicians regarding the CCSVI hypothesis are met with charges of elitism and professional arrogance. We also hear the terms ‘pharmaceutical lobby’ and ‘being afraid to lose patients’ being bandied about.”

Referring to the widespread patient testimony about CCSVI, Reekers cautioned: “Remember even with Perkin’s tractors, patients felt better. This is placebo effect,” he said.

He called for a prospective randomised controlled trial, performed by unbiased physicians with one sham arm (with percutaneous transluminal angioplasty for the subclavian vein) which would have independent blinded follow-up in order to settle the issue.

On the issue of deferring a randomised controlled trial, Reekers told Interventional News: “Offering a non-proven treatment, without any objective parameters of success, which is mainly physician- and patient-driven carries a huge risk of damaging the reputation of interventional radiology as being a serious clinical specialty. With any future negative trial outcome, patients will have a strong case to go to court for deceit, and claim damages. Finally, all new introduced techniques in interventional radiology, like uterine fibroid embolization, had objective parameters of technical success which supported their introduction. The so-called abnormality, CCSVI, is completely unproven and is only a chimera.”

Siskin, who argued against the motion, said “as long as a reasonable percentage of patients are telling us that they are “feeling better” and are “satisfied” with their outcome after this procedure, we are going to continue offering it to our patients. It is our responsibility as physicians to do that.”

However, he acknowledged that there has not been enough research on CCSVI and that ongoing research would be critical to the understanding of CCSVI and the role of angioplasty in treating patients with multiple sclerosis.

 “It is an important responsibility for us to make sure that appropriate research is performed so that we can grow our understanding of CCSVI as an entity and to determine its influence on multiple sclerosis-related symptoms. It is important that we improve our understanding of the basic science behind CCSVI, validate previously reported data and perform a prospective randomised trial,” he said.

He also argued that “I do not remember any of the pioneers of many of our other procedures waiting until all the questions were answered before performing procedures such as subintimal angioplasty, chemoembolization, radioembolization and uterine fibroid embolization on patients.” He told delegates that his group was currently enrolling into a prospective randomised, blinded trial to evaluate angioplasty as a treatment for CCSVI in multiple sclerosis patients. “I am aware of several other trials getting underway,” he noted.

Gary Siskin told Interventional News: “Interventional radiology has achieved its success as a specialty by constantly looking for new solutions to old problems, and this newly described entity is just another example of that. Many prominent members of our specialty have found preliminary success with treating this condition, which has provided the basis and impetus for further research. The difficulty in finding objective parameters of success and the possibility of discovering that angioplasty is not bringing about the success that patients are looking for should not stop our specialty from performing well designed clinical trials to answer this question. Patients suffering with multiple sclerosis deserve this.”

Before the debate, 80% of the audience voted in favour of the proposition “The level of evidence linking chronic cerebrospinal venous insuffiency (CCSVI) and multiple sclerosis is inadequate and the clinical benefits of endovascular treatment are suspect” and 20% against. After the debate, 74% of the audience voted that they were for the proposition and 26% voted that they were against.

For interventional radiologists carrying out uterine artery embolization, there is every reason to proclaim its benefits widely, share its proven success rates and take pride in the body of evidence that supports the use of this procedure. Uterine artery embolization is one of the few procedures in the interventional field which has been tested by many randomised trials and is backed by strong level I evidence. However, sometimes, it is equally important to be able to recognise that this procedure is not for everyone. It is good to know when to say “no”, Jafar Golzarian, professor of Radiology and Surgery and director of the Division of Interventional Radiology & Vascular Imaging, Minneapolis, USA, tells Interventional News

So when is uterine artery embolization absolutely contraindicated?

There are a few absolute contraindications including infection, any gynecological cancers and pregnancy.

What about relative contraindications?

These are more debatable. Endometritis is one of the relative contraindications. In my view, in such a situation, a patient needs antibiotics before considering uterine artery embolization. For patients with post-menopausal bleeding, which happens with persistent fibroids, one should first rule out malignancy before considering uterine artery embolization. It is important to remember that patients with additional diseases or conditions such as endometriosis, endometrial hyperplasia etc may need more workup before determining if they could benefit from uterine artery embolization. 

Are there some types of fibroids that do not respond well to uterine artery embolization? What is the evidence to back this?

We used to not offer uterine fibroid embolization to patients with narrow stalk or to patients with endocavitary fibroids. New reports show that embolization is effective in those patients. It seems that cervical fibroids do not respond well to embolization. In other types, such as infarcted fibroids, the expected benefit is also low as the goal of uterine artery embolization is precisely to provoke fibroid infarction. However, we have no strong evidence to back this, but this is based on personal experience and others’ experiences. 

Can you define the types of patient for whom you would say “no” to uterine artery embolization?

Two types of patients come to my mind. I would say “no” to embolization in a patient who has an intracavitary fibroid which is less than 3cm. Such a patient could benefit from a hysteroscopic removal. The second type is a patient with menorrhagia who has fibroids, but also a polyp. I would propose treating the polyp first and then re-evaluating the patient for the embolization if the patient is still symptomatic.

What is the current understanding on how uterine artery embolization impacts fertility?

There are now more studies demonstrating successful pregnancy after uterine artery embolization. A recent paper published by Pisco et al has shown the same outcome after uterine artery embolization and surgery in terms of the number of pregnancies. However, the only paper which can be classified as level one evidence, by Mara et al, favours myomectomy over embolization. 

A session on thrombolysis saw discussion on the characteristics of three different thrombectomy devices in the CX Innovation Showcase at this year’s CX Symposium.

Iris Baumgartner, Bern, Switzerland, spoke on the EkoSonic system (EKOS), Gerry O’Sullivan, Galway, Ireland, told delegates about his experience with the Trellis device (Trellis/Covidien), and Kim Hodgson, Springfield, USA, focused his presentation on the Angiojet system (Medrad Possis).

EkoSonic

“The problem we face is that anticoagulation therapy does not actively dissolve the clot and 40% of patients continue to propagate thrombus despite therapeutic levels of heparin. Anticoagulation therapy does not prevent long-term damage to the vein and valves, leading to high levels of post thrombotic syndrome, particularly iliofemoral, and we still have high mortality rates from pulmonary embolism despite anticoagulation,” Baumgartner said.

In 2008, for the first time a grade 2B recommendation for catheter directed thrombolysis was issued by the American College of Chest Physicians, she added. “In patients with extensive proximal deep vein thrombosis, meaning iliofemoral (symptoms

One possibility for the management of thrombus in patients with extensive iliofemoral thrombosis is the MicroSonic Accelerated Thrombolysis (EkoSonic), Baumgartner told delegates.

“This is a catheter system that is inserted mostly in extensive thrombosis via the popliteal vein all the way up to the cava. Ultrasonic energy causes fibrin strands to thin and loosen, exposing plasminogen receptor sites. With extensive thrombus with need high doses and with this system I can lower the dose. Thrombus permeability and lytic penetration are dramatically increased and the ultrasound pressure waves force the lytic agent deep into the clot. As compared to systemic thrombolysis I only need 10% of the dose and this is relevant for bleeding complications,” she described.

Baumgartner referred to a study from Francis et al which showed that thrombus exposed to ultrasound absorbed 48% more tissue plasminogen activator (tPA) in one hour, and 89% more tPA in four hours than thrombus not exposed to microsonic pressure.

“As compared to non-ultrasound accelerated catheter-directed thrombolysis, the overall lysis proportion with the EKOS system is higher and the time needed to resolve is significantly shorter. Major bleeding rates are also lower, although this is on the borderline of being statistically significant as compared to non-ultrasound accelerated thrombolysis.”

“A second field where we now have a grade 2B recommendation is in patients with pulmonary embolism who are not haemodynamically compromised where we have an indication for intravenous thrombolysis,” she pointed out.

Baumgartner added that the EkoSonic system consists of a three-lumen catheter with a wire support that is exchanged by the ultrasound system cooling the area around, and a third layer where we have the recombinant tPA infused, and it goes out directly into the thrombus.

“You can have these areas where you want to treat between 6 and 50cm in length. You can separate your treatment area by decision on which device you are using, 6, 12, 18, 30, 50cm,” she concluded. 

Trellis

“I need something which happens in a single session, so Trellis is what I use. You can look at deep vein thrombosis treatment in many ways, but for me single session vs. multisession is the way to look at it. That is the reason why I consider the use of Trellis and Angiojet devices,” O’Sullivan said.

The Trellis device is designed byThomas Fogarty and promotes targeted delivery of thrombolytic agents. The treatment area is isolated within occluding balloons, and there is mechanical dispersion of infused thrombolytic agents and aspiration following treatment.

It is an over-the-wire device, with an 8F sheath.

“You have balloons inflated at both ends of your treatment zone. The treatment zone is where you deliver the tPA or other thrombolysis drug that you choose to use. At the end of the treatment time, which takes 5–10 minutes, you aspirate the tPA out,” O’Sullivan said.

He presented four different scenarios where and how the Trellis device would be used:

•  Type 1: Inferior vena cava clear/no pulmonary embolism, ilio-femoral deep vein thrombosis and patent popliteal vein. “This is the easiest and quickest case, with Trellis Peripheral Infusion System only,” he said
•  Type 2: Inferior vena cava thrombus/pulmonary embolism and ilio-femoral (and not popliteal vein) deep vein thrombosis: There is need for an inferior vena cava filter but it is possible to treat the case in a single session with the Trellis Peripheral Infusion System.
• Type 3: Inferior vena cava clear, all calf veins acutely thrombosed, deep vein thrombosis up to iliacs: Catheter-directed thrombolysis 48–72h or Trellis system in the popliteal vein upwards and catheter-directed thrombolysis for 24h afterwards.
•  Type 4: Inferior vena cava to ankle venous thrombosis: “This is the most difficult case and will need an inferior vena cava filter, the Trellis Peripheral Infusion System and 24–48h catheter-directed thrombolysis,” noted O’Sullivan.

O’Sullivan said that, in the Galway experience of isolated pharmaco-mechanical thrombolysis with Trellis, performance of the device was technically successful. “Technical success with SIR Class 2/3 clearance of thrombus was achieved in 89 out of 91 patients, and primary and secondary patency rates were high. There were no access site haematoma, no bleed requiring transfusion, no gastro-intestinal or intracranial bleed. There was one minor nasal bleed. Overall pharmaco-mechanical thrombolysis is a safe technique with low risks,” he concluded.

Angiojet

Hodgson said that thrombolysis/ thrombectomy devices work in different ways – mechanical vs. pharmacological or vs. a combination of both. However, he said, “what really counts is clearance of the clot and re-establishment of flow but without damaging the thrombosed blood vessel, without damaging the access vessel or pathway to the thrombus, the downstream vessels, tissues or organs, or the bystander organs (brain or kidneys), and achieving thrombolysis rapidly enough to avoid tissue necrosis.”

He told delegates that in terms of successful outcomes, the devices are ‘good’ in chronic thrombi, ‘better’ in sub-acute thrombi and have their best results in fresh thrombi.

“But with increasing age comes increasing drug doses, devices passages and revascularisation times, as well as local and systemic complications and failure to achieve revascularisation. Any claims of superiority for one device over another in actual clinical practice are unsubstantiated,” he stated.

The Angiojet thrombectomy system, he said, is the only device that can work without the use of a lytic agent, it is the only device that has a purely mechanical mode. You can use this without fearing that your patients will develop cerebral haemorrhage, gastro-intestinal bleeding or other problems. It can be used when lytic agents are contraindicated. The system comes in 4–6F catheter diameters, 50–140cm shaft lengths, for 2–20mm vessel diameters.

Hodgson said that the Angiojet device can also be used as a high pressure drug delivery system with its Power-Pulse mode. It promoted deep penetration of lytic agent into the clot. “To varying degrees it extracts the lytic and prevents systemic lysis. But the degree to which this enhances overall efficacy is unquantified.”

Hodgson summarised the pros and cons of the Angiojet device. “The pros are that it is a purely mechanical lysis, or can be used in combination with a lytic drug, and you can treat a broad range of vessels, veins and arteries, and get a rapid restoration of flow,” he said. The cons are that there are some limited run-times, there are potential systemic effects, and the risk of iatrogenic haemorrhage, Hodgson concluded.

Volcano announced the signing of a supply agreement with ev3, a Covidien company, under which Volcano will supply its proprietary intravascular ultrasound (IVUS) technology for use in ev3’s plaque excision systems. Utilising the digital IVUS transducer incorporated in Volcano’s market leading EagleEye catheter product line, this new product will be capable of running on Volcano’s global installed base of 5,000 systems.

Scott Huennekens, president and CEO of Volcano commented, “In addition to our internally developed image guided therapy products, such as the Vibe RX imaging balloon (commercially available in the EU only), we have looked to other medical device industry leaders to join us in differentiating therapeutic devices by adding integrated imaging capabilities. Covidien is an innovative company that recognises the value of onboard visualisation and is committed to bringing these new, more precise therapies to market to help improve patient outcomes. This agreement also exemplifies the value of our one system, many solutions strategy facilitated by our multi-modality platform.”

Plaque excision systems, also called atherectomy devices, are catheters that remove plaque that blocks arteries and interrupts blood flow. Instead of compressing plaque against the vessel wall‰Û¥as is the case with balloon and stent therapy alone‰Û¥plaque excision systems remove the obstruction from the vessel, thereby restoring blood flow, reducing damage to the vessel wall, and preserving future treatment options. IVUS integration offers advantages in immediate assessment of the plaque to better guide therapy.

Over 270,000 atherectomy procedures have been performed with ev3’s SilverHawk and TurboHawk directional atherectomy catheters, uniquely designed to direct the therapy specifically to the diseased portion of the vessel while avoiding healthy portions of the vessel. The latest generation of TurboHawk plaque excision catheters are designed to remove all plaque morphologies from diseased arteries, including calcified lesions.

“By partnering with Volcano, we continue to lead atherectomy therapy, enabling physicians to visualise the diseased portion of the artery for optimal plaque excision,” said Stacy Enxing Seng, president, Peripheral Vascular, Covidien. “This is particularly important as we believe preparing and treating the vessel for drug delivery, whether via drug coated balloon or stent, will create a breakthrough in treating lower extremity peripheral arterial disease.”

Spectranetics announced that it plans to initiate the EXCITE ISR (Excimer laser randomised controlled study for treatment of femoropopliteal in-stent restenosis) clinical trial following the recent conditional approval of the company’s investigational device exemption application by the FDA.

The study will compare the safety and efficacy of excimer laser atherectomy utilising the Spectranetics’ Turbo-Tandem and Turbo Elite products in conjunction with balloon angioplasty, with that of balloon angioplasty alone in a 2:1 fashion on patients with femoropopliteal in-stent restenosis, a condition caused by the development of scar tissue within a previously implanted stent.

EXCITE ISR will enrol up to 353 patients at up to 30 sites in the USA, with first patient enrolment expected within 30 days. The primary safety endpoint will measure major adverse events defined as death, major target limb amputation and target lesion revascularisation through 30 days following the procedure. The trial’s primary efficacy endpoint is freedom from clinically-driven target lesion revascularisation, which will be evaluated at six months following the procedure. These results will be included in a 510k filing with the FDA. The study will employ three separate independent core laboratories and an independent Data Safety and Monitoring Board.

“We are very pleased to be able to start the EXCITE ISR trial and plan to enrol the first patient within the next 30 days,” stated Shar Matin, senior vice president of operations, Product Development and International. “There is currently no medical device cleared by the FDA to treat patients with in-stent restenosis. Spectranetics is proud to be on the leading edge of clinical research to evaluate laser atherectomy for the treatment of peripheral artery disease.”

Eric Dippel, national principal investigator for the EXCITE ISR trial and interventional cardiologist at Trinity Regional Health System in Bettendorf, Iowa, USA commented, “Effective treatment for in-stent restenosis in upper leg interventions has yet to be proven in a scientifically rigorous randomised trial. The intent of this trial is to provide evidence for laser atherectomy in this difficult patient population, and I am looking forward to initiating this landmark clinical trial.”

Cordis announced the launch of Sleek OTW catheter, a new .014” percutaneous transluminal angioplasty (PTA) balloon catheter designed to help physicians save limbs and enhance patients’ lives. This new PTA balloon was first launched at LINC (Leipzig Interventional Course, Leipzig, Germany) and ISET (International Symposium on Endovascular Therapy, Miami, Florida) earlier this year.

Lower limb amputation is a last resort for many patients with end-stage peripheral arterial disease (PAD). It is estimated that as many as 160,000 lower limbs are amputated every year in the USA and 60-70% of these amputations are performed as the first-line therapy. These lower-limb amputations come with a mortality rate of as much as 70% at five years.

The Sleek OTW catheter has a unique balance of excellent pushability with a small crossing profile that helps physicians reach small arteries below-the-knee and into the foot to restore blood flow to the lower limb. A broad portfolio of sizes is also offered with PTA balloon diameters of 1.25mm to 5.0mm and lengths up to 220mm that allow physicians to treat diffuse disease with less inflation.

“The Sleek OTW catheter offers our most advanced technology designed to treat challenging below the knee disease,” said Campbell Rogers, chief scientific officer, Global Head R&D. “This addition to our lower extremity product portfolio underscores our commitment to providing solutions that help save limbs and improve the quality of life for patients with advanced peripheral vascular disease.”

Boston Scientific  announced the start of patient enrolment in the SuperNOVA clinical trial, an international, prospective, single-arm, non-randomised trial evaluating the safety and effectiveness of the Innova self-expanding bare-metal stent system in patients with stenosis of the superficial femoral artery (SFA) or proximal popliteal artery (PPA).

Enrolment is planned for up to 300 patients at 50 sites in the USA, Canada and Europe. The first patient was enrolled by Subhash Banerjee, associate professor of medicine and chief of Cardiology at the VA Medical Center in Dallas, Texas, USA.

The Innova stent system is designed to treat peripheral vascular lesions in arteries above the knee, specifically the SFA and PPA. It consists of a nitinol, self-expanding bare-metal stent loaded on an advanced low-profile delivery system. The innovative architecture features a closed cell design at each end of the stent for improved radial force and fracture resistance, and an open cell design along the stent body that does not compromise flexibility. Stent deliverability is enhanced with a tri-axial catheter shaft designed to provide added support and placement accuracy as well as dual deployment options and radiopaque markers to enhance ease of use. This stent is 6F compatible and ranges from 5mm to 8mm in diameter and 20mm to 200mm in length.

“Treating arteries above the knee is difficult because the challenging anatomy can lead to stent fractures and higher restenosis rates,” said Richard J Powell, section chief of Vascular Surgery at Dartmouth-Hitchcock Medical Center in Lebanon and global principal investigator of the trial. “I believe the Innova stent offers a unique design that provides excellent radial strength while remaining flexible and durable, which is critical to sustaining patency in treated SFA and PPA lesions.”

“The Innova stent is engineered to offer an advanced solution in treating blockages within these critical arteries,” said Joe Fitzgerald, senior vice president and president of Boston Scientific’s Endovascular Unit. “Its design is intended to improve blood flow and provide greater long-term stent durability, ultimately improving the overall quality of life for patients with peripheral artery disease.”

The Innova stent system received CE mark in March 2011, and the company plans to begin marketing the product in the EU and other countries in the second quarter of 2011. In the USA, it is an investigational device, limited by applicable law to investigational use only and not available for sale.

Covidien announced that it has received Premarket Approval (PMA) from the FDA for the Pipeline embolization device, indicated for the endovascular treatment of adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms in the internal carotid artery from the petrous to the superior hypophyseal segments.

Pipeline is a new class of embolization device designed to divert blood flow away from the aneurysm in order to provide a complete and durable aneurysm embolization while maintaining patency of the parent vessel.

“The Pipeline embolization device is a breakthrough and life-saving endovascular treatment for large or giant wide-neck brain aneurysms,” said Joe Woody, president, Vascular Therapies, Covidien. “Pipeline now offers hope for those patients who have had no other options for treating this often debilitating and even fatal medical condition.”

The Pipeline embolization device PMA application was based on the results of the PUFS (Pipeline for uncoilable or failed aneurysms) clinical trial, a single-arm study of large and giant, wide-neck or fusiform aneurysms that included safety and efficacy data on 108 patients.

“Brain aneurysms are a silent killer because most show no symptoms over time,” said Christine Buckley, executive Director, The Brain Aneurysm Foundation. “The Pipeline embolization device now provides patients with a safe and effective treatment of large or giant, wide-neck aneurysms, which remained an unmet clinical need until now.”

The Pipeline embolization device has received CE mark approval in Europe and has been sold outside the United States since July 2009. The Pipeline device will be available at the existing clinical sites in the USA beginning this quarter.

An exciting opportunity awaits interventional radiologists with the miniaturisation of EVAR devices. The new-generation devices have shown a trend towards being lower in profile and some are designed for an entirely percutaneous approach.

In contrast, first-generation endografts had a large profile (24–27 outside diameter), were inflexible, cumbersome to deploy, worked sub-optimally in complex anatomy and had a high incidence of procedural complications. Over time, physicians have identified that with these first generation devices, there were frequent late complications such as device migration, modular component separation, high permeability and endotension, endoleaks and loss of structural integrity.

The concerns about durability of EVAR devices are based on the fact that most published trials reported significant re-intervention rates for complications such as endoleak and kinking. This weakness in durability also has an economic consideration, as the cost of re-intervention and post-procedural surveillance means that EVAR with older technology, is less cost-effective than open surgical repair.

Another challenge associated with EVAR is that only 50% of AAA patients were candidates for EVAR because half of the patients are excluded because of unfavourable neck anatomy and iliac anatomy.

“The two areas of opportunities in EVAR applicability are the proximal neck (with respect to conformability, accommodation and seal zone) and the iliac access (where profile, trackability and kink resistance come into play),” said Zvonimir Krajcer, programme director, Peripheral Vascular Interventions, Department of Cardiology, St Luke’s Episcopal Hospital and Texas Heart Institute, Houston, USA.

He told delegates at ISET in January 2011 that on the other hand newer generation devices offer ease of use, better accuracy in deployment, wider applications for challenging anatomy, low-profile delivery systems, more opportunities for non-surgical specialists and better durability. The question remains, how will device modification contribute to improved results?

EVAR moving to PEVAR era

“Learn and embrace totally percutaneous EVAR (PEVAR) techniques, or be left out,” Krajcer said at ISET.

Krajcer explained the goals of PEVAR: to reduce mortality and morbidity, hospital stay and offer a quicker return to normal lifestyle. The percutaneous approach also offers shorter procedure times and less blood loss.

“EVAR will be more frequently done in the cath lab and interventional radiology suite, due to the cost issues of operating room time, operating room personnel, equipment, anaesthesia and anaesthesiologist,” he predicted.

Krajcer noted that technological advances in EVAR delivery systems such as a reduction in profile and simplified delivery would facilitate a totally percutaneous approach. “A totally percutaneous approach to EVAR requires suitable closure devices, appropriate endovascular delivery systems, careful patient selection, expertise in technique, and proper facilities with ready access to surgical services. There is also definitely a learning curve associated with the procedure,” he said.

Krajcer clarified that not all commercially available devices are specifically designed for, or are suitable for percutaneous use. He mentioned that Endologix’s IntuiTrak, which has a contralateral percutaneous indication with a simple deployment mechanism, is “In Europe, 15% of EVAR procedures are performed in PEVAR fashion, but in Australia, 70% of the EVAR are performed in PEVAR fashion.”

Later, at the iCON meeting in Arizona, Krajcer said, “An entirely percutaneous approach to EVAR appears safe and feasible in patients with suitable anatomy. ”

He gave the results of the first multicentre, prospective, randomised controlled trial of this approach (the PEVAR trial) which was initiated in 2010 under an investigational device exemption in the USA to determine the technical effectiveness and clinical benefit of this approach. Krajcer reported the initial PEVAR trial roll-in phase results. “Enrolment has begun across the 20 participating centres and is expected to be completed this year,” he said.

Ipsilateral ‘pre-close’ percutaneous access was performed with the Abbott Vascular’s Prostar XL or ProGlide suture-mediated closure devices.

“The PEVAR procedures were performed using Endologix’s IntuiTrak Endovascular System. Using the integrated 19F introducer sheath, the bifurcated endograft was implanted in combination with proximal or limb extensions as per the patient’s anatomy. Contralaterally, vessels were either pre-closed if a limb extension was required, or closed using standard percutaneous technique. Procedural technical success, defined as successful common femoral access and closure, was evaluated, as were vascular and systemic adverse events. Post-procedural follow-up has been scheduled at one and six months.

“Among 33 patients enrolled in the roll-in phase, technical success rates of 97% (access) and 100% (endovascular repair) have been achieved, with no major adverse events observed. Patients were discharged from the hospital at an average of 1.4 days following the procedure,” said Krajcer.

Results

A total of 24 patients (96% men), mean age of 72±6.4 years were enrolled. Mean proximal neck and aneurysm sac diameters were 27±2.9mm and 5.3±0.4cm, respectively. Patients were maintained either under general (63%) or local (37%) anaesthesia, and were treated either by vascular surgeons or interventionalists with surgeons as a multidisciplinary team. All endovascular aneurysm repairs were performed successfully. Over a mean procedure time of 117 minutes, estimated blood loss was 206mL.

In-hospital complications were limited to two blood transfusions for anaemia and one surgical repair for contralateral scrotal haematoma in a patient who underwent standard percutaneous access with manual compression for closure. Ankle-brachial indices remained unchanged from the pre-operative values to the one-month values.

Patients were discharged from the hospital at a mean of 1.4 days postoperatively. Within one month, no deaths, ruptures, conversions to open repair, secondary procedures, renal complications, or other serious vascular events were observed.

Recent trials have shown carotid artery stenting to be equivalent to endarterectomy. However, stenting is linked to a higher microembolic burden. Sumaira Macdonald’s presentation examining the burden of microembolic signals for endarterectomy, carotid stenting with flow reversal and carotid stenting with filter protection showed interesting results.

“Carotid artery stenting is associated with a higher microembolic burden than carotid endarterectomy. The rate and procedural stage of highest risk depends on the embolic protection device used,” said Sumaira Macdonald, consultant vascular radiologist and honorary clinical senior lecturer, Newcastle, UK, at the annual iCON meeting in Phoenix, USA, in February.

She presented the results of a recent non-randomised comparison of carotid endarterectomy, filter-protected carotid artery stenting and carotid artery stenting with flow reversal utilising microembolic signals on transcranial Doppler as primary outcome event.

Results from the study (Gupta N, Corriere MA, Dodson TF et al. JVS Dec 1st 2010 [Epub]) showed that carotid endarterectomy had the fewest microembolic signals (largely in the post-protection phase). This was followed by flow reversal carotid artery stenting; in this case, signals detected were mostly in the pre-protection phase. Of the three procedures, filter-protected carotid artery stenting had the highest number of signals and these were mostly recorded during the protection phase.

“Clearly, there is room for improvement for carotid artery stenting,” Macdonald said. She told delegates that the patient is vulnerable pre-protection for proximal embolic protection devices and even during the protection phase when filters are used.

Does filter-protected carotid artery stenting have more microembolic signals than unprotected carotid artery stenting?

Filters are associated with significantly more microemboli compared with unprotected carotid artery stenting, said Macdonald based on DWMRI findings and procedural transcranial Doppler.

“Small randomised controlled trials (Macdonald S, Evans DH, Griffiths PD et al. Cerebrovascular Diseases 2010;29:282–289; and  Horowitz MB et al. J Vasc Surg. 2008 Apr;47(4):760–5. Epub 2008) demonstrate a significant increase in microembolic signals for filter-protected carotid artery stenting compared with unprotected carotid artery stenting and a substantial increase in hyperintensities on diffusion-weighted imaging for filter-protected compared with unprotected carotid artery stenting. In the trial evaluating both surrogate markers, periods of contrast injection were excluded from the final analysis as gaseous microemboli introduced during angiography would have constituted a major confounding variable. In a substudy of the International Carotid Stenting Study (Bonati L, Jongen LM, Haller S et al) comprising 231 patients, two of seven participating centres performed unprotected carotid stenting and the remaining five largely filter-protected carotid stenting. Sixty eight per cent of filter-protected cases and 35% of unprotected cases had new diffusion-weighted imaging lesions (odds ratio 3.28 [1.50–7.20], p=0.003),” Macdonald noted.

She also referred to a small randomised controlled trial (Montorsi P, Caouti L, Galli S et al, presented at TCT 2010) which reported a substantial reduction in diffusion-weighted imaging and a significant reduction in microembolic signals on transcranial Doppler for proximal protection compared with filters and a non-randomised evaluation of filters versus proximal protection (Schmidt A, Diederich KW, Scheinert S et al. J Am Coll Cardiol 2004;44:1966–9) showing significant reduction in microembolic signals during emboligenic stages (lesion crossing, stent deployment, post-dilatation). However, “establishment and retrieval of protection devices (both filter-type and proximal) are universally emboligenic stages,” Macdonald said, and catheterisation of the aortic arch and great vessel origins necessary for establishment of proximal protection explains the pre-protection microembolic penalty incurred during use of proximal protection systems.

Proximal embolic protection devices represent a significant improvement in the management of the microembolic burden associated with carotid stenting and there is the potential for important advances in terms of both access and stent design.

Are closed-cell stents better than open-cell stents?

Macdonald told delegates that a systematic review (Schnaudigel S, Gröshel K, Pilgram SM et al. Stroke 2008;39:1911–1919) comprising 32 studies (1,363 carotid stenting procedures) demonstrated that closed cell stents significantly reduced diffusion-weighted imaging hyperintensities compared with open cell stents. A small randomised controlled trial (Schillinger M, Dick P, Wiest G et al. J Endovasc Ther 2006;13:312–319) comparing the Wallstent and the ePTFE covered Symbiot stent (stopped early due to excessive restenosis in the covered stent limb) demonstrated significantly fewer microembolic signals on transcranial Doppler with the covered compared with the bare metal stent.

No level one evidence for benefit from embolic protection devices

Jos C van den Berg, Lugano, Switzerland, told delegates at iCON 2011 that currently there is no level one evidence establishing the benefit of embolic protection devices.

He suggested that carotid artery stenting can be performed at least as safely without distal embolic protection devices. “Carotid artery stenting without embolic protection has similar results to the procedure with protection. However, the use of embolic protection devices still does not protect from adverse events post-procedure, and they do not prevent hyperperfusion,” he said.

“A randomised comparison of protected and non-protected carotid stenting would require several thousands of patients. As such, there is no level one evidence. Several studies indicate that stenting can be performed without distal embolic with a risk comparable to protected stenting. “Importantly, carotid stenting with distal filter-type embolic protection devices lead to more embolic events (as demonstrated with transcranial Doppler and diffusion-weighted MRI), a large part of the procedure is unprotected anyway and adverse events related to embolic protection devices do occur,” noted van den Berg. “Experience with proximal protection devices is currently growing, and shows great promise,” he said.

William Alfred Cook, founder of the Cook Group global network of companies and a pioneer in the development of life-saving minimally invasive medical device technology, died on 15 April 2011 åÊin his Bloomington home of congestive heart failure. He was 80. Survivors include his wife Gayle Karch Cook, son Carl and daughter-in-law Marcy, and a granddaughter, Eleanor.

Started in the spare bedroom of his Bloomington apartment in 1963, the Cook family of businesses has grown into a global entity of 42 companies employing more than 10,000 people. The firms manufacture cardiovascular diagnostic and interventional products, antimicrobial catheters, vascular filters, bioengineered tissue grafts, extruded and injection-molded plastics, precision stainless steel tubing, urological equipment, OB/GYN devices and endoscopic instruments. In addition, other Cook Group corporations are involved in real estate, travel services, and aircraft service and maintenance.

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Company officials said that the business will continue as a privately held corporation with global headquarters in Bloomington, USA. Carl Cook, 49, has been named chief executive officer of Cook Group, with Steve Ferguson continuing as chairman and Kem Hawkins continuing as Cook Group president. 2010 annual global revenue for the company was approximately US$2 billion.

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‰ÛÏBill‰Ûªs many contributions to the medical industry are unprecedented, and his many contributions to the community and to charitable organisations are extraordinary,‰Û said Steve Ferguson, chairman of Cook Group.

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Cook was born 27 Jan 1931, in Mattoon, USA and grew up in nearby Canton. He earned a bachelor‰Ûªs degree in biology from Northwestern University in 1953 and pursued post-graduate work in physics at Trinity University in San Antonio, Texas.

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In 1963, he founded the Cook company in Bloomington on US$1,500 invested capital, with Bill and his wife Gayle as its only employees. The company‰Ûªs first products were a set of percutaneous wire guides, catheters and needles that helped popularise minimally invasive medical procedures that put an end to exploratory surgery. Cook innovations included firsts in coronary and peripheral stenting, endovascular treatment of aortic aneurysms, difficult airway management and other medical disciplines that helped shape modern medicine worldwide.

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Always believing he had a responsibility to use his wealth for good causes, Cook was instrumental in the restoration and reuse of many historic buildings in southern Indiana, including over forty properties on the National Register of Historic Places. He was founder of the Monroe County YMCA and sponsor of the Star of Indiana Drum and Bugle Corps, a traveling and performing group of young people.

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GE Healthcare has renewed its collaborative relationship with STERIS. This collaboration provides physicians with a unified system for imaging and surgical procedures in integrated and hybrid operating rooms.

The relationship brings together GE Healthcare’s best-in-class Innova imaging systems for single plane with custom‰Ûdesigned HD 360° Suites from STERIS featuring LED surgical grade lighting, video‰Ûswitching and visualisation systems, and equipment management solutions. The two companies will collaborate to facilitate room planning and installation for seamlessly integrated interventional suites tailored to the precise needs of each facility.

“STERIS and GE Healthcare are committed to helping healthcare providers optimise their capital investment and room utilisation while also prioritising quality and the safety of patients and staff,” said William O’Riordan, vice president and general manager, STERIS.

“By taking the specific needs of each facility into consideration during the planning and installation, we will be able to enhance workflow and increase productivity,” said Chantal Le Chat, general manager-Interventional Radiology, GE Healthcare.

Bolton Medical announced that it has enrolled the first patient in its ADVANCE clinical trial to study the safety and performance of the Treovance abdominal stent-graft with Navitel delivery system. The case was performed, on 30 March 2011, by Vicente Riambau, chief of Vascular Surgery at the Hospital Clinic, Barcelona, Spain. 

Treovance is offered with the Navitel delivery system, an intuitive low profile system with a mechanical advantage and a completely detachable sheath assembly. Navitel also includes the reliable proximal clasping system of Bolton Medical’s Relay thoracic stent-graft providing accurate deployment.

“The Treovance abdominal stent-graft performed very well,” said Vicente Riambau, “The stent-graft is highly conformable and offers superior fixation through suprarenal barbs and uniquely designed infrarenal barbs.” Regarding the delivery system, Riambau stated, “The low profile Navitel delivery system offers deployment precision due to its proximal stent clasping. The introducer sheath is detachable, offering significant clinical benefits such as less access vessel trauma and the ability to perform a percutaneous approach.”

The primary objective of the ADVANCE study is to assess the safety and performance of the device in subjects with infrarenal aortic aneurysms. Results of this study will support CE marking. Thirty patients will be enrolled at five institutions located in Germany, Italy, The Netherlands and Spain.

According to Bolton Medical, enrolment of the US clinical trial for Treovance is expected to start in May 2011. In the USA the study will be called BENEFIT.  

Straub Medical AG announced that it has received an upgraded CE mark approval for its Rotarex S and Aspirex S families of rotational endovascular catheters. These catheters restore blood flow in occluded blood vessels. 

The technically optimised S-series, representing the latest generation of Rotarex and Aspirex catheters, have been introduced to the market in mid 2010 with a class-II CE mark approval, which allowed for the treatment of occlusions of peripheral arteries. The recent regulatory upgrade to a CE class III product comes along with a notably enhanced indication: the catheters, in combination with the Straub Medical Drive System, are now intended and marketed for the percutaneous transluminal removal of material from occlusions of blood vessels outside the cardiopulmonary, coronary and cerebral circulations. Both Rotarex S and Aspirex S catheters are indicated for native blood vessels or vessels fitted with stents, stent grafts or native or artificial bypasses.

While Aspirex S catheters are intended to be used for the removal of fresh thrombotic or thromboembolic material, Rotarex S catheters are intended for removal of thrombotic, thromboembolic and atherothrombotic material from fresh, subacute and chronic occlusions.

“The successful upgrade to a CE class III product and the approval of the enhanced indication underline the safety and effectiveness of our devices”, stated Walter Mayerl, director Regulatory Affairs at Straub Medical. “We are glad that our devices can now be used to help an even wider range of patients suffering from vascular occlusive disease”, said Immanuel Straub, founder, chairman and president of Straub Medical AG.

“An important advantage of our technology is that it allows for rapid vessel reopening and immediate restoration of blood flow without the potential risks of bleeding when administering thrombolytics, or of inducing barotraumata or embolisations when dilating the lesion with a balloon, or of vessel trauma and neointima hyperplasia when implanting a stent”, illustrated Dirk Dreyer, director Global Sales & Marketing at Straub Medical. “And even if the occlusion occurs in a previously stented region of the blood vessel or in a bypass, our catheters can be used to safely reopen these segments again.”

Venous use

The enhanced indication includes the approval of venous use of the Aspirex S catheter family. “The enhanced approval together with the venous indication for Aspirex S greatly accelerate Straub Medical’s evolution as a leading provider of devices for the treatment of vascular occlusive disease,” explained Gido M Karges, Managing Director of Straub Medical AG. “Being established as one of the market leaders in the treatment of peripheral arterial occlusive disease, we now aim to widen the portfolio of both products and indications. One of our goals is to improve the physician’s ability to treat venous disease, e.g. DVT, with our new generation of catheters and a dedicated range of complementary devices designed specifically for venous use. With enhanced indications and products for arterial and venous use we hope to expand interventional treatment to patients who previously would not have had that treatment option.”

A unique formulation of antioxidants taken orally before imaging with ionising radiation minimises cell damage, noted researchers at the Society of Interventional Radiology’s 36th Annual Scientific Meeting in Chicago, USA. In what the researchers said is the first clinical trial of its kind, as much as a 50% reduction in DNA injury was observed after administering the formula prior to CT scans.

“In our initial small study, we found that pre-administering to patients a proprietary antioxidant formulation resulted in a notable dose-dependent reduction in DNA injury,” said Kieran J Murphy, professor and vice chair, director of research and deputy chief of radiology at the University of Toronto and University Health Network, Toronto, Ontario, Canada. “This could play an important role in protecting adults and children who require imaging or a screening study,” he added.

“Pre-administering this formula before a medical imaging exam may be one of the most important tools to provide radioprotection and especially important for patients in the getting CT scans,” said Murphy. The study’s data support the theory about a protective effect during these kinds of exposure, he explained.

“There is currently a great deal of controversy in determining the cancer risks associated with medical imaging exams. Although imaging techniques, such as CT scans and mammograms, provide crucial and often life-saving information to doctors and patients, they work by irradiating people with X-rays, and there is some evidence that these can, in the long run, cause cancer,” explained Murphy. The researchers responded to this patient need by exploring a way to protect individuals from these potentially harmful effects. This may be of importance to interventional and diagnostic radiologists and X-ray technologists who have occupational exposure also.

The small study showed that even though many antioxidants are poorly absorbed by the body, one particular mixture was effective in protecting against the specific type of injury caused by medical imaging exams. People are 70% water, and X-rays collide with water molecules to produce free radicals that can go on to do damage by direct ionisation of DNA and other cellular targets, noted Murphy. The research team evaluated whether a special combination of antioxidants have an ability to neutralise these free radicals before they can do damage.

“Our intent was to develop an effective proprietary formula of antioxidants to be taken orally prior to exposure that can protect a patient’s DNA against free radical mediated radiation injury, and we have applied to patent this formulation and a specific dose strategy,” said Murphy.

The experiments measured DNA damage as a surrogate marker for DNA injury. Blood was drawn from two study volunteers in duplicate, creating four individual tests per data point. DNA strand breaks are repaired by a big protein complex that binds to the site of the damage. The researchers labeled one of the proteins with a fluorescent tag. Then, under a powerful 3-D microscope, the DNA is examined for signs of repair. The more repair that is seen, the more DNA damage must have been done by the CT scan to initiate that repair. The experiments clearly showed a reduction of DNA repair in the treatment group, which means that there was less DNA injury as a result of pre-administering the antioxidant mixture, said Murphy.

The researchers concede that this is a small study and that a lot more research needs to be done; however, these initial results point toward a positive future for this kind of treatment. The group said the next step is a clinical trial in Toronto.

Interventional radiologists have completed the first human randomised controlled trial of therapeutic renal denervation, a procedure that uses a catheter-based probe inserted into the renal artery that emits high-frequency energy to deactivate the nerves near the kidneys (or in the renal artery) that are linked to high blood pressure. The researchers say these results confirm that renal denervation may be an effective therapy for reducing—and consistently controlling—resistant hypertension when current medications have failed. The results were presented at the Society of Interventional Radiology’s 36th Annual Scientific Meeting in Chicago, USA.

“Renal denervation, a minimally invasive, effective treatment, appears to be safe in the short term with a low incidence of local complications. Its efficacy to lower blood pressure in patients with resistant high blood pressure will be better evaluated with the results of a subsequent trial,” said Marc R Sapoval, professor of clinical radiology and chair of the cardiovascular radiology department at Hôpital Européen Georges-Pompidou in Paris, France.

“After six months, 39% of patients receiving the endovascular denervation treatment had reached the recommended blood pressure level and, overall, 50% of patients showed a measurable benefit of the intervention,” he added.

“It is estimated that one in every four American adults has high blood pressure. High blood pressure increases the risk of heart and/or kidney disease and stroke because it makes the heart work too hard,” Sapoval explained. “The renal sympathetic system, which are the small nerves that carry the signal from the brain to the kidney and back from the kidney to the brain, plays an important role in the regulation of blood pressure levels. The disruption of these nerve fibres has a positive effect on blood pressure levels,” he continued.

“Given its impact on the central sympathetic drive, endovascular renal denervation may have applicability in additional disease states such as heart failure, cardio-renal syndrome, hepato-renal syndrome, and in the prevention of progression of chronic kidney disease and hypertension in end-stage renal disease—with the added benefit of helping to raise public awareness on the dramatic burden of this disease,” said Sapoval.

This study targeted only patients with resistant essential hypertension. Sapoval said the causes of high blood pressure can be wideranging, such as a benign tumour in the adrenal gland, stenosis of the renal artery, the taking of certain prescription drugs or other factors.

By randomised assignment, 106 adult patients with uncontrolled hypertension received either oral medication or the renal denervation treatment. Six months after the intervention, systolic pressure fell an average of 32 mmHg and diastolic pressure fell an average of 12 mmHg. This initial cohort has been expanded to a multicenter randomised controlled trial at 24 international sites.

Sapoval conceded that this was a small study, that the work still experimental, and that renal denervation should be performed only by interventional radiologists on screened patients in strictly controlled academic and/or research settings. However, he noted that it shows great promise for those suffering from resistant hypertension. Sapoval remarked that the patients had a short hospital stay for safety reasons, but that the treatment might possibly be performed in an outpatient clinic in the future.

While the treatment’s efficacy to lower blood pressure in patients with resistant hypertension will be better evaluated with the results of future trials, the interventional radiologist said that some clinical findings (like hypertension in young patients, hypertension after child bearing, etc.) can also be used by doctors to determine if other specific diagnostic tests are needed to rule out potential causes of the hypertension.

Sapoval stated that the trial was funded by the catheter and specific generator manufacturer and that there is a huge need for more research in independent hands. To that end, there will be an upcoming nationwide U.S. Food and Drug Administration trial involving more than 100 US-based interventional radiology teams. He also stressed that the published results need confirmation by follow-up with the succeeding trial’s patients after one and two years. Sapoval hopes that new trials, conducted and funded by public entities, such as the National Institutes of Health in the United States; NICE (the National Institute for Clinical Excellence) in the United Kingdom and the Ministry of Health in France, for example, and similar agencies in other countries, will help researchers to move forward and discern which patients would benefit from this technique, possibly in addition to medication.

Pelvic arterial embolization, a minimally invasive therapy, is a safe and effective treatment for postpartum haemorrhage, said researchers at the Society of Interventional Radiology’s 36th Annual Scientific Meeting in Chicago, USA.

Between January 2000 and June 2010, researchers analised the outcomes of 225 patients (average age, 32 years), who underwent pelvic arterial embolization  for primary postpartum haemorrhage. The results showed cessation of bleeding following an initial session without the need for additional therapy or surgery.

“This large 225-patient study, in which 86% of the patients treated showed positive results illustrated that pelvic arterial embolization has the advantages of being a safe, rapid, economic and repeatable procedure—performed without general anesthesia,” said Ji Hoon Shin, associate professor with the radiology department, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea. “Moreover, pelvic arterial embolization preserves the uterus, allowing resumption of menstruation and preserving fertility.”

“Traditional surgical methods to stem postpartum haemorrhage, such as uterine artery ligation, uterine suturing and hysterectomy, involve the loss of fertility and risks from general anesthesia,” said Shin. “Many obstetricians and gynecologists know the usefulness of pelvic arterial embolization over surgery, yet there is not always a connection between them and the interventional radiologist,” explained Shin. “Collaboration with these doctors is imperative with the hope that they will begin to refer patients to an interventional radiologist for treatment, making pelvic arterial embolization a more popular alternative to surgery,” he added.

“All women who carry a pregnancy beyond 20 weeks’ gestation are at risk for postpartum haemorrhage, which remains one of the major causes of maternal morbidity and mortality throughout the world,” said Shin. “Many case studies have reported on pelvic arterial embolization’s usefulness for the control of postpartum haemorrhage, yet most of them involved fewer than 100 patients, this study had 225 patients with 86% showing positive results,” he added.

Shin notes that with repeat pelvic arterial embolization, the clinical success rate increased to 89%. “As is with many other interventional radiology procedures, this is a life-saving, minimally invasive treatment that preserves patient quality of life and speeds recovery,” stated Shin.

Once a baby is delivered, the uterus normally continues to contract expelling the placenta. After the placenta is delivered, these contractions help compress the bleeding vessels in the area where the placenta was attached. The most common cause of postpartum haemorrhage occurs if the uterus does not contract strongly enough and these blood vessels bleed freely, said Shin. Such excessive and rapid blood loss can cause a severe drop in the mother’s blood pressure and, if left untreated, may lead to shock and death.

For many years, hysterectomy has remained the only solution to controlling bleeding and arresting postpartum haemorrhage that was unresponsive to conservative medical management, said Shin. In surgery, to control the haemorrhage, a physician must open the lower abdomen and tie off bleeding arteries to the uterus, repair the uterus or remove it entirely.

With pelvic arterial embolization, an interventional radiologist makes a tiny nick in the skin in the groin and, using real-time imaging, guides a catheter into the arteries supplying the uterus and injects small particles that block the blood flow to the uterus and stop the bleeding.

While these results are promising, Shin stressed the necessity to explore the impact of the treatment on future fertility. Most patients referred for pelvic arterial embolization had stable blood pressure, noted Shin, so other studies will be forthcoming on the treatment’s role in a clinical setting where the patient’s condition may be more unstable.

AngioScore announced the launch of new, longer AngioSculpt PTA Scoring Balloon Catheters for the treatment of peripheral artery disease. The new devices have received FDA 510(k) clearance to market for the dilatation of lesions in the iliac, femoral, ilio-femoral, popliteal, and infra popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

These new peripheral artery disease catheters are not labeled for use in the coronary or neuro-vasculature.

The new AngioSculpt devices incorporate longer (40 mm) balloons and scoring elements in diameters 2.0, 2.5, 3.0 and 3.5mm. These new sizes are expected to be particularly useful in treating lesions typically encountered in the treatment of complex peripheral artery disease below the knee. Barry Weinstock, interventional cardiologist, Orlando Regional Medical Center, commented, “These new longer AngioSculpt devices represent a significant improvement over conventional angioplasty balloons for the treatment of complex lesions because of their ability to achieve more predictable luminal expansion and a lower rate of dissection, thereby minimising the need to perform adjunctive stenting. This advantage is particularly important when working below the knee as stenting in those vessels is generally undesirable.”

Thomas R Trotter, president and CEO of AngioScore, added, “The peripheral artery disease market is one of the rapidly growing segments of the overall interventional cardiovascular market worldwide. Over 1.5 million percutaneous peripheral procedures are now being performed annually worldwide, and the growth rate is accelerating due to improved diagnosis and the increasing incidence of important risk factors, such as adult-onset diabetes mellitus. We believe that the AngioSculpt line of scoring balloon catheters is particularly useful in treating this very challenging and serious disease.”

AngioSculpt represent the next generation in angioplasty balloon catheters for both coronary and peripheral artery disease. Their innovative nitinol scoring elements provide unique circumferential scoring of plaque, leading to precise and predictable luminal enlargement across a wide range of lesion types while avoiding “geographic miss” through their unique anti-slippage properties.

Understanding that venous angioplasty‰ÛÓa medical treatment used by interventional radiologists to widen the veins in the neck and chest to improve blood flow‰ÛÓis safe may encourage additional studies for its use as a treatment option for individuals with multiple sclerosis, said researchers at the Society of Interventional Radiology‰Ûªs 36th Annual Scientific Meeting in Chicago, USA.

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‰ÛÏOur study will provide researchers the confidence to study angioplasty as a multiple sclerosis treatment option for the future,‰Û said Kenneth Mandato, interventional radiologist, Albany Medical Center, Albany, USA. In a retrospective study, 231 multiple sclerosis patients (age range, 25 to 70 years old; 63.7% women, åÊ36.3%men) underwent this endovascular treatment of the internal jugular and azygos veins with or without placement of a stent. ‰ÛÏOur results show that such treatment is safe when performed in the hospital or on an outpatient basis‰ÛÓwith 97% treated without incident,‰Û Mandato noted.

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He added, ‰ÛÏOur study, while not specifically evaluating the outcomes of this endovascular treatment, has shown that it can be safely performed, with only a minimal risk of significant complication. It is our hope that future prospective studies are performed to further assess the safety of this procedure.‰Û Complications included abnormal heart rhythm in three patients and the immediate re-narrowing of treated veins in four patients. All but two of the patients were discharged within three hours of receiving this minimally invasive treatment.

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About 500,000 people in the United States have multiple sclerosis. ‰ÛÏThere are few treatment options that truly improve the quality of life of those with the disease, and some of the current drug treatment options for multiple sclerosis carry significant risk,‰Û said Mandato. In 2009, Paolo Zamboni, a doctor from Italy, published a study that suggested that chronic cerebrospinal venous insufficiency (CCSVI) might contribute to multiple sclerosis and its symptoms. The idea is that if these veins were widened, blood flow may be improved, which may help lessen the severity of multiple sclerosis-related symptoms.

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The Society of Interventional Radiology issued a position statement in Autumn 2010 supporting high-quality clinical research to determine the safety and effectiveness of interventional multiple sclerosis treatments, recognising that the role of CCSVI in multiple sclerosis and its endovascular treatment by an interventional radiologist via angioplasty could be transformative for patients. ‰ÛÏThis is an entirely new approach to the treatment of patients with neurologic conditions, such as multiple sclerosis. The idea that there may be a venous component that causes some symptoms in patients with multiple sclerorosis is a radical departure from current medical thinking,‰Û said Gary P Siskin, interventional radiologist and chair of the Radiology Department, Albany Medical Center and the co-chair of the SIR research consensus panel on multiple sclerosis held in October 2010.

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‰ÛÏIt is important to understand that this is a new approach to multiple sclerosis. As a result, there is a healthy level of skepticism in both the neurology and interventional radiology communities about the condition, the treatment and the outcomes,‰Û said Siskin. ‰ÛÏInterventional radiologists have been performing venous angioplasty for decades and have established themselves as pioneers in this area of vascular intervention.‰Û

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While the use of angioplasty and stents cannot be endorsed yet as a routine clinical treatment for multiple sclerosis, SIR agrees that the preliminary research is very promising and supports studies aimed at understanding the role of CCSVI in multiple sclerosis, at identifying methods to screen for the condition and at designing protocols for exploratory therapeutic trials. ‰ÛÏIf interventional therapy proves to be effective, multiple sclerosis patients should be treated by doctors who have specialised expertise and training in delivering image-guided venous treatments,‰Û said Siskin. Interventional radiologists pioneered angioplasty and stent placements and use those treatments on a daily basis in thousands of patients with diverse venous conditions.

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Mandato noted that research still needs to be done concerning patient selection, technique and the outcomes after this procedure, including improvement in symptoms and quality of life and the durability of the response.

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 A new interventional radiology treatment that blocks blood supply to men’s enlarged prostate glands shows comparable clinical results to transurethral resection of the prostate (TURP), considered the most common treatment. However, this minimally invasive treatment—prostatic artery embolisation—has none of the risks associated with TURP, such as sexual dysfunction, urinary incontinence, blood loss and retrograde ejaculation, noted researchers at the Society of Interventional Radiology’s 36th Annual Scientific Meeting in Chicago.

“Benign prostatic hyperplasia (BPH) is so common that it has been said that all men will have an enlarged prostate if they live long enough. I believe that a minimally invasive interventional radiology treatment—prostatic artery embolisation (PAE)—will be the future treatment for benign prostatic hyperplasia or men’s noncancerous enlarged prostates,” noted João Martins Pisco, chief radiologist, Hospital Pulido Valente and director of interventional radiology at St. Louis Hospital, Lisbon, Portugal.

“Prostatic artery embolisation blocks blood supply to treat noncancerous benign prostatic hyperplasia. This study is significant because it shows comparable clinical results to transurethral resection of the prostate —without the risks of surgery, such as sexual dysfunction, urinary incontinence, blood loss and retrograde ejaculation,” added Pisco, professor at the Faculty of Medical Sciences, New University of Lisbon. “While the gold standard treatment for enlarged prostates has been TURP, minimally invasive prostatic artery embolisation is safe, performed under local anesthesia and has comparable clinical results—without TURP’s limitations and risks,” said Pisco.

The interventional radiologist indicated that prostatic artery embolisation patients experienced symptom improvement comparable to TURP; however, certain urodynamic results (such as flow rate of the urinary stream) did not improve as much as with TURP.

TURP can be performed only on prostates smaller than 60–80 cubic centimeters; there is no size limitation for prostatic artery embolisation treatment, said Pisco. “The best results are obtained on patients with prostates larger than 60 cubic centimeters and with very severe symptoms,” he added. “Pelvic arterial embolisation may be the only feasible and effective treatment for benign prostatic hyperplasia in those men who cannot have TURP due to the size of their prostate (80+ cubic centimeters) or because it is inadvisable for them to undergo general anaesthesia,” said Pisco.

An estimated 19 million men in USA have symptomatic benign prostatic hyperplasia, (14 million undiagnosed; 2 million diagnosed but untreated). Statistics show that a small amount of prostate enlargement is present in many men over age 40, as many as 50% experience symptoms of an enlarged prostate by age 60 and more than 90% of men over the age of 85 will report symptoms.

“The men who were treated with prostatic artery embolisation showed significant clinical improvement,” said Pisco. In this study, 84 men (ranging in ages from 52 to 85) with symptomatic benign prostatic hyperplasia underwent prostatic artery embolisation after failing other medical treatments for at least six months, said Pisco. The men were followed for more than nine months (on average), and prostatic artery embolisation was found to be technically successful in 98.5% of the patients—with 77 men showing “excellent” improvement, six men “slight improvement” (but needing no medications) and one experiencing no improvement (due to receiving an incomplete embolisation), he added. Two hours after prostatic artery embolisation, most men were passing urine less frequently. It was impossible to embolise both prostate arteries in the men showing “slight improvement” due to advanced atherosclerosis, said Pisco.

Interventional radiologists in the USA received approval to serve as authorised users for Y90 in February 2011. A course organised by the Society of Interventional Radiology from 10–13 February 2011 in Scottsdale, USA, ‘Y90: Are YoU Ready?’ offered a challenging, rigorous curriculum to attendees with testing and demonstrated competency. There was enthusiastic participation from over 106 interventional radiologists. Interventional News found out more from the participants…

The importance of authorised user status

Y90 therapy represents yet another tool we have to treat cancer in the liver. While the idea was not new, the delivery was complicated by side-effects related to non-target delivery, and complications related to surgical approaches to catheterisation. By applying interventional radiology “translational” thinking and advances in catheter/imaging technology and embolization, interventional radiologists have taken what was once an effective but high-risk surgical technique and translated it into a safe and effective outpatient procedure. 

Initial prospective series suggest that this therapy should play a central role in the management of both colorectal metastases and primary liver neoplasms. To deliver on this promise, we need to be able to deliver the therapy where the patients live. That means that hundreds, if not thousands, of interventional radiologists need to build on their existing skills and begin to deliver this new therapy.

In the USA, delivery of a therapeutic radioisotope is regulated by the States as well as the national Nuclear Regulatory Commission. The rules that govern who is allowed to order and manage a therapeutic radioisotope are periodically reviewed and updated. Those that applied to Y90 microparticles were written for a time before interventional radiologists assumed such a central role in these procedures and in some centres, the old rules were an impediment—either preventing interventional radiologists from therapy, or impeding efficient patient care. 

Since 2000, Riad Salem, professor of Radiology, Oncology and Surgery and director of Interventional Oncology at the Robert H Lurie Comprehensive Cancer Center at Northwestern University recognised the importance of modifying the rules to allow interventional radiologists to serve as authorised users for this specific isotope consistent with our new approach to treatment. “Interventional radiologists were at the forefront of research and development of this new technique. It was only rational that we could obtain authorised user status. I have been an authorised us since 2002,” said Salem.

Salem is a recognised leader in developing and validating interventional radiology’s approach to this therapy. In 2006, he approached the leaders of the American Board of Radiology, the Society of Interventional Radiology (SIR) and other groups to ask them to petition the regulatory agency to add interventional radiologists to the list of Y90 authorised users.

Representing the SIR, he has testified in front of federal agencies several times working towards a regulatory path for interventional radiologists to obtain authorised user status. 

Cognisant of the critical importance of ensuring that the treatment is delivered with consistency and expertise, he developed a rigorous 80-hour curriculum, an A to Z of this treatment, which was presented to the committee along with the application. 

In mid 2009, the committee entrusted with setting the rules for usership convened in Chicago which included Salem, Brian F Stainken, 2009–2010 president of the Society of Interventional Radiology, Matthew A Mauro, American Board of Radiology trustee and Gary J Becker, executive director of the American Board of Radiology. The proposed rules changes were discussed and a proposal submitted for review suggested that mastery of catheterisation and embolization were central to effective and safe delivery of this isotope.

When combined with existing training in radiation physics and radiation safety, recently trained board certified interventional radiologists could apply for Y90 authorised user status. As a result of these efforts, the changes were published in early February 2011. “This represents a great opportunity, but is also a significant responsibility. Authorised users are responsible for the safe dose calculation and delivery of this potent isotope, as well as the clinical management of patients. “We believe that it is our responsibility to ensure that involved with Y90 should be offered the opportunity to learn ‘from the ground up’ about arterial brachytherapy,” said the participants from the course.

Hence, with the support of key industry leaders, Salem and Stainken joined with Matthew S Johnson, professor of Radiology and Surgery and director of Interventional Oncology, Indiana University School of Medicine to organise this 3.5-day course held 10–13 February. Those who pass the exam will be awarded a certificate from SIR attesting to their accomplishment. This combined with board certification, experience and completion of device specific mentoring as needed, represents a very high standard for competency and proficiency which should suffice to justify endorsement as an authorised user which means that many more interventional radiologists will be offering the treatment and beginning at a much higher level of expertise. 

Trends from the meeting

The meeting demonstrated the need to view patients within the entire medical realm, the importance of understanding where Y90 fits into the therapeutic algorithm; understanding the importance of evaluation of a person’s complete medical history and condition as it relates to prognosis following therapy, especially following Y90.

• Some challenges that need to be overcome
• Standardisation of evaluation/technique
• Ensuring the highest level of competence throughout the entire community
• Demystifying radioembolization and its component parts
• Garnering support from the medical oncologic community
• Keeping up with interventional radiologists leading the development of this therapy

An article entitled “Research reporting standards for radioembolization of hepatic malignancies” was published in the March 2011 issue of the Journal of Vascular and Interventional Radiology.

Merit Medical Systems announced that it has received 510(k) clearance from the FDA for its Asap thrombus aspiration catheter.

The Asap catheter is designed for the quick removal of fresh, soft emboli and thrombus from the arterial system. The catheter features large aspiration lumen to facilitate quick aspiration and tapered tip for smooth catheter transition.

Fred P Lampropoulos, Merit’s chairman and chief executive officer said, “We are pleased that the Asap, which we have been selling successfully in Europe, will now be available in the United States.”

Sales of the Asap will commence in the United States immediately.

AccessClosure announced results from the first study comparing the pain associated with deployment of different vascular closure devices as the primary endpoint, the study was published in the March edition of the Journal of NeuroInterventional Surgery.

The single-blinded, randomised, single-centre, controlled trial compared the discomfort associated with the Mynx 5F Vascular Closure device versus the Angio-Seal Evolution device. Both pain at closure and the pain increase from baseline to closure were significantly higher in patients undergoing closure with the Angio-Seal Evolution device (p=0.009 and 0.002, respectively). There was no difference in the rate of closure success or closure complications between the devices.

“This is an important study for physicians and patients,” said Gregory D. Casciaro, president and CEO of AccessClosure. “The study scientifically examined whether the Mynx device reduced the pain associated with arteriotomy closure seen with the Angio-Seal Evolution device and provides an evidence-based understanding that will help guide choice about vascular closure device options.”

The Institutional Review Board-approved study provided for enrolment of 128 patients based on power analyses with the intention of performing preliminary statistical analysis following enrolment of 64 patients (32 patients in each arm).

Patients, nurses administering a commonly utilised, well-validated visual analog scale to assess patient pain, and study coordinators were blinded to the vascular closure device treatment. The primary end point was defined as the change in pain from baseline (pre-closure) to post-closure, assessed by the vascular closure device. The patient’s reporting of the most painful part of the procedure from a multiple choice selection (1. Lidocaine injection and access, 2. contrast injection and 3. closure) was a secondary endpoint along with major and minor adverse events associated with vascular closure device and closure.

As pre-specified, enrolment was terminated following analysis of the first 64 patients enrolled because of the statistically significant difference in comfort detected.

The reduction in pain favoring the Mynx device compared to the Angio-Seal Evolution device was highly significant for both primary and secondary endpoints, which measured the pain at closure and the change in pain from baseline (pre-closure) to closure. Over twice as many patients undergoing closure by Angio-Seal closure as those undergoing Mynx closure reported the most painful part of the procedure to be vascular closure deployment (88% vs. 34%, p<0.001).

The large difference in pain experienced between Mynx and Angio-Seal patients was hypothesised to be secondary to the presence or absence of compression elements within the devices. No major or minor adverse events were reported in patients undergoing either Mynx or Angio-Seal closure procedures, although the study was not powered to detect a difference in adverse complications.

“Patient comfort is an important aspect in selecting a vascular closure device and every step taken to improve the patient’s experience is a step in the right direction,” said J Mocco, University of Florida College of Medicine, Gainesville, Florida, USA, co-author of the study.

About the Mynx Vascular Closure device

The Mynx device is indicated for use to seal femoral arterial access sites while reducing times to haemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilising a 5F, 6F or 7F procedural sheath. The Mynx device has not been approved for the reduction of pain in vascular closure procedures.

This device utilises an extravascular water-soluble polyethylene glycol (PEG) sealant that is gently deployed at the surface of the femoral artery. Following deployment, the sealant immediately expands sealing the common femoral artery and tissue tract. The sealant dissolves within 30 days, leaving nothing behind but a healed artery.

The Mynx received its first FDA approval in May 2007, has been used in over 750,000 procedures, and is available in two sizes for 5F and 6F/7F procedural sheaths.

Three trials presented recently have found that drug-eluting stents score over angioplasty, or bare metal stents, in the periphery. ACHILLES has shown better primary patency for Cordis’ Cypher stent in the infrapopliteal region over angioplasty, YUKON has shown a similar benefit for Translumina’s Yukon BTX stent below the knee over a bare metal stent, and Abbott Vascular has used the results of the DESTINY trial to obtain the CE mark for Xience V. Interventional News does a round-up.

Angiographic 12-month results with Cordis’ sirolimus-eluting stent are “very promising and have the potential to be considered a first-line therapy option for suitable infrapopliteal lesions.” Investigators say that Cypher Select is also suitable for use in diabetic patients.

ACHILLES is the first multicentre, randomised comparison of Cordis’ sirolimus-eluting stent to angioplasty in patients with claudication and critical limb ischaemia. The results were presented by Dierk Scheinert, Leipzig, Germany at the annual LINC meeting.

The 200-patient study compared the performance of the Cypher Select Plus sirolimus-eluting stent to balloon angioplasty in de novo and restenotic native infrapopliteal arterial lesions with follow-up at six weeks, six months and 12 months. The primary endpoint is in-segment binary restenosis at 12 months by quality assurance. Ninety nine patients received the Cypher Select Plus stent. Mean number of stents implanted were 1.8 and number of lesions was 113. Seventy four (74.7%) patients were available for 12 months follow-up. A hundred and one patients were scheduled for balloon angioplasty only. Of these, 93 received percutaneous balloon angioplasty alone. Eight patients crossed-over to the stent group. Eighty (79.2%) patients were available for 12 months follow-up.

“What is of note [in the patient demographics] is that 64% in both treatment arms were diabetic patients, which underlines the relevance of this for diabetes mellitus,” said Scheinert.

Referring to lesion characteristics, he noted, “The large number of patients were in Rutherford 4 and 5 (46% in the stent group and 42% in the angioplasty group) respectively. One-third of the patients in both groups had Rutherford 3 lesions.”

Pre-procedure stenosis was 68.8±19.3% in patients treated with Cypher and 74±19% in patients who received angioplasty (p=0.056). Post-procedure stenosis was 13.3±14.3% in the stent group and 25.9±15.2% in the angioplasty group (p 

“One year results with Cypher are promising in focal lesions. Complete one-year follow-up data including clinical endpoints and wound healing assessments will be presented at a later time point once analyses are complete,” he concluded.

YUKON-BTX final results

A polymer-free sirolimus-eluting stent achieved significantly higher primary and secondary patency rates at one year compared to bare metal stents, the final results of the YUKON-BTK have shown. Data of the randomised, double-blind study were presented by Thomas Zeller, Herz-Zentrum Bad Krozingen, Bad Krozingen, Germany, at the annual LINC meeting.

Zeller told delegates that the purpose of the study was to compare the effectiveness of the treatment with balloon-expandable Yukon-BTX drug-eluting stent over the treatment with Yukon-BTX uncoated stent in patients with ischaemic infrapopliteal arterial disease. Primary endpoint was one-year primary patency rate, defined as freedom from in-stent restenosis (≥50%) detected with angiography or, if appropriate, with duplex ultrasound. “We enrolled not only critical limb ischaemia patients but also claudicants with moderate to severe claudication. The lesion length was somewhat longer as compared to the DESTINY trial,” said Zeller.

One hundred and sixty one patients were enrolled and randomised to the sirolimus-eluting stent (82) or the bare metal stent (79). In the drug-eluting stent group, 12-month follow-up data were available for 62 patients, and, in the bare metal stent group, 12-month follow-up data were available for 63 patients.

The results showed that, at one year, the bare metal stent group had primary patency rate of 55.6% and secondary patency rate of 71.4%. The sirolimus-eluting stent group had primary patency rate of 80.6% (p=0.004) and secondary patency rate of 91.9% (p=0.005). A comparison of patients in each treatment group who were Rutherford class ≤2 (moderate or no claudication) at baseline, six and 12 months showed a significant difference in favour of the sirolimus-eluting stent. At baseline, the percentage of Rutherford class ≤2 patients was 9.9% for the sirolimus-eluting stent and 15.5% for the bare metal; at six months, it was 71.4% for drug-eluting stent and 66.1% for the bare metal stent; and at 12 months it was 78.8% for the sirolimus-eluting stent 63.9% for the bare metal stent (p=0.04).

Xience Prime update

Abbott has received the CE mark for its Xience Prime everolimus-eluting coronary stent system for the treatment of critical limb ischaemia or severe claudication of the lower leg. Data generated on Xience V drug-eluting stent from the DESTINY trial supported the CE mark application. DESTINY’s multicentre trial compared Xience to Abbott’s bare metal Multi-link Vision stent, in 140 patients with claudication of the lower leg, with lesion lengths less than 40mm.

The 12-month results from DESTINY demonstrated that Xience V had better patency compared to the bare metal stent at 12 months (85.2% Xience V versus 54.4% Multi-link Vision; p=0.0001). This difference was especially pronounced between six and 12 months, where the difference in patency rate significantly diverged, as the rate for the bare metal stent fell to nearly 50% while the rate for Xience V remained above 85%.

“The DESTINY trial demonstrates that everolimus eluting stents result in significantly better patency at 12 months compared to bare metal stents for patients with critical limb ischaemia of the lower leg, and the use of everolimus eluting stents can potentially provide significantly better outcomes for these patients,” said Marc Bosiers, head of the Department of Vascular Surgery at St. Blasius Hospital in Dendermonde, Belgium, and principal investigator of the DESTINY trial.

Krishna Rocha-Singh, Prairie Vascular Institute, Springfield, USA, questioned the clinical relevance of the DESTINY, ACHILLES and YUKON trial designs at the annual LINC meeting in Leipzig, Germany.

He told delegates, “Marc Bosiers, Thomas Zeller and Dierk Scheinert are to be congratulated for their excellent work demonstrating that…

• Interventions using coronary drug-eluting stents below the knee in claudicants (Rutherford category 2 to 3) is a new, emerging study inclusion criteria
• You can do trials in patients with ischaemic limbs while excluding Rutherford Category 6 patients
• Coronary drug-eluting stents have superior binary patency rates compared to percutaneous transluminal angioplasty/bare metal stents in patients with so-called “ischaemic limbs” with mean lesion lengths less than 3cm.

“Was anyone in this audience really surprised that coronary drug-eluting stents would have a superior technical success rate compared to angioplasty? Or that the binary patency rates of coronary drug-eluting stents were going to be superior to angioplasty or bare metal stents? Or even that we continue to do below-the-knee drug-eluting stents studies which focus on stent patency as a primary endpoint, rather than “patient-centric” outcomes in patients with critical limb ischaemia?” Rocha-Singh asked.

Going beyond the coronary paradigm in study design

“How clinically relevant is six to 12-month index vessel patency? How does it translate into more ‘patient-centric’ surrogates such as limb preservation, pain control, maintenance of function and mobility and wound healing?” Rocha-Singh argued.

“Patients do not necessarily want to know whether the stent I have put in is patent or not. They want to know about their limb preservation, they want to know about their pain control, they want to know about their maintenance of mobility and function and they want to know about wound healing. At this stage I must acknowledge that Marc Bosiers did look at wound healing and my hope is that Dierk Scheinert in his primary manuscript will look deeper at that because I do think that it is essential. So I am suggesting here that all of us look beyond the coronary paradigm when we start dealing with below-the-knee study designs,” he said.

He also pointed out that there were patient vs. physician-centred outcomes and that lessons learned from the surgical literature had shown that graft patency is equated with a successful clinical outcome and amputation-free survival.

“However, graft patency and its association with other ‘patient-centric’ outcomes such as symptom relief, wound healing and mobility are poorly correlated and these are very complex patients,” he said.

Patency is only part of the answer, he said. Pointing to the literature, Rocha-Singh highlighted that in a 2007 study (Taylor et al, Journal of American College of Surgery) which set out to determine success after bypass for critical limb ischaemia, clinical success was defined as achieving all of the following: graft patency to the point of wound healing, limb salvage at one year, maintenance of ambulatory status at one year and survival for six months.

The results of this study which enrolled 331 patients with Rutherford class 3–6 lesion, showed that graft patency and limb salvage at three years was 73%, but the total clinical success when combining all four of the parameters was only 44%.

“For below-the-knee lesions, expensive technologies should yield better patient-relevant outcomes—perhaps an adequate percutaneous transluminal angioplasty result alone is sufficient. Although an important element, in the USA, payers will not reimburse for ‘stent patency’. We must challenge each other to promote rigorous trial designs to advance this field beyond technology-driven surrogates,” Rocha-Singh said.

New data presented at the American Heart Association Scientific Sessions show that renal denervation significantly reduces blood pressure in patients with treatment-resistant hypertension. Murray Esler, Baker IDI Heart and Diabetes Institute, Melbourne, Australia, presented results from the Symplicity HTN-2 trial. The results were simultaneously published online in The Lancet.

Elser told delegates that “Activation of renal sympathetic nerves is key to pathogenesis of essential hypertension.” The proprietary radiofrequency generator used in the procedure is automatic, operates on low power and has built-in safety algorithms.

Investigators set out to assess effectiveness and safety of catheter-based renal denervation for reduction of blood pressure in patients with treatment-resistant hypertension.

Symplicity HTN-2 is a multicentre, prospective, randomised trial. Between 9 June 2009 and 15 January 2010, Esler et al randomised 106 patients who had a baseline systolic blood pressure of 160mmHg or more (≥150mmHg for patients with type 2 diabetes), despite taking three or more antihypertensive drugs in a one-to-one ratio to undergo renal denervation (n=52) with previous treatment or to maintain previous treatment alone (control group, n=54) at 24 participating centres. The primary effectiveness endpoint was change in supine office-based measurement of systolic blood pressure at six months. Primary analysis included all patients remaining in follow-up at six months.

Forty nine (94%) of 52 patients who underwent renal denervation and 51 (94%) of 54 controls were assessed for the primary endpoint at six months. Investigators found that office-based blood pressure measurements in the renal denervation group decreased by 32/12mmHg (+/- 23/1mmHg, baseline of 178/96mmHg; p

Between-group differences in blood pressure at six months were 33/11mmHg (p

At six months, 84% of the subjects receiving renal denervation had a decrease in systolic blood pressure of 10mmHg or more versus 35% of 51 controls (pThere were no major procedure-related or device-related complications.

Dierk Scheinert, Leipzig, Germany, who presented these results at the LINC annual meeting noted that there were no serious device- or procedure-related adverse events in the 52 patients. There was one femoral artery pseudoaneurysm treated with manual compression; one post-procedural drop in blood pressure resulting in a reduction in medication; one urinary tract infection; one prolonged hospitalisation for evaluation of paraesthesias and one back pain treated with pain medications which resolved after one month.

“Six month renal imaging in 43 patients showed no vascular abnormality at any radiofrequency treatment site. One magnetic resonance angiography indicates possible progression of a pre-existing stenosis unrelated to radiofrequency treatment with no further therapy warranted,” he said.

There were no changes in measured renal function with denervation, which suggests that the procedure itself and associated haemodynamic changes have no deleterious effects on the kidneys.

The results from the Symplicity trial, a multicentre randomised trial which enrolled patients with treatment resistant essential hypertension, showed that catheter-based renal denervation resulted in significant reductions in blood pressure. Iris Baumgartner, angiologist, Bern, Switzerland, critiqued the trial at the annual LINC meeting, Leipzig, Germany.

“It is hard to criticise good science, but I am going to try. The trial demonstrates for the first time in humans that renal sympathetic denervation can reduce blood pressure in a safe way and that results are sustained long-term (24 months). However, several concerns remain and must be explored,” she said.

Blood pressure

Going to the primary endpoint, the office blood pressure change was -32mmHg vs. +1mmHg at six months (p

A second concern was whether the patient group enrolled had blood pressure that was truly resistant. “Although salt restriction and spironolactone treatment are effective in resistant hypertension, only 17% of participants received an aldosterone antagonist. So was it a truly resistant patient population that was treated?

“Only 20% of the patients who received renal sympathetic denervation had medication dose decreased,” she noted.

Renal arteries

“When it comes to the anatomy, there might be some potential radiofrequency-induced tissue damage that will accelerate atherosclerosis in the injury points. What is the long-term damage from this?” asked Baumgartner.

She also brought up the issue of anatomical problems such as the existence of multiple renal arteries. “In such cases, are all renal arteries to be treated?” she asked.

Other issues

Baumgartner noted that renal sympathetic efferent nerves may re-grow after injury raising the possibility of finite time limits on the physiological effects of the procedure. “We need a longer-term follow-up to assess this aspect,” Baumgartner said.

With regard to the indications, she noted that predictors of blood pressure response have not yet been identified. “We have the data on resistant severe hypertension. Can the results of this study be generalised to a larger hypertensive population?

“The cost-effectiveness also needs to be examined, if renal sympathetic denervation is to be performed in milder forms of hypertensions and consequently in larger numbers of patients,” she said.

Baumgartner added that chronic renal disease was associated with sympathetic overactivity, and said patients with renal failure may be appropriate candidates for renal sympathetic denervation.

“If renal denervation is performed early in the process of disease, it might prevent development of target organ damage and detrimental consequences of hypertension. But we do not know yet, we do not have these endpoint,” said Baumgartner.

“The interventional renal denervation approach may offer the opportunity of a build-in therapy with benefits throughout patients’ lifetimes,” she concluded.

ContextVision has introduced two innovative solutions at the 2011 European Congress of Radiology (ECR) in Vienna, Austria. The Mammo PlusView addresses current limitations of x-ray image diagnosis for the detection of breast cancer, while the GOPView iRV helps achieve superior, real-time images with the ability for dose reduction during interventional fluoroscopy procedures.

The Mammo PlusView is the only product available on the market to provide a configurable and cost-effective mammography viewing workstation with computer-aided detection functionality. It can be set up as a stand-alone system or integrated with a picture archiving and communications system, analyses images and generates computer-aided detection marks to highlight suspicious areas, such as microcalcification clusters and masses. The C-CAD by ContextVision is easily integrated into various picture archiving and communications systems from other vendors, providing diversified solutions for physicians.

“Mammography images can be difficult to read at times, and radiologists struggle not to overlook breast cancers. The integrated computer-aided detection technology in the Mammo PlusView provides radiologists with a second set of eyes before they make their decision, alerting them to areas that may require more attention and therefore ensuring any abnormalities in breast tissue are evaluated appropriately,” said Anita Tollstadius, chief executive officer of ContextVision.

The GOPView iRV is able to accurately define the movements between the images to quickly find structures and orientation for interventional procedures in real time and without time gaps, resulting in enhanced low-dose images that offer superior clarity and higher contrast, regardless of the detector solution used.

Angiodynamics has announced the launch of the next generation DuraMax stepped tip chronic dialysis catheter. This 15.5 French, high flow/high performance design features proprietary “curved tip catheter technology”. The catheter tip is designed to reduce arterial insufficiency, provide superior over the wire performance, and improve ease of use during catheter insertion.

A dedicated guidewire lumen securely centers the guidewire at the leading edge of the venous tip. Approximately 30% to 50% of chronic catheter placements are exchange procedures performed over a guidewire, and an increasing number of de novo catheter placements are placed over a wire due to the advantages of reduced tissue trauma. This catheter provides a significant advantage in ease of use for all chronic catheter placements. 

The curved tip profile helps prevent arterial insufficiency, and maintains flows in the event of vessel wall apposition. Clinical blood flow rates of 400mL/min at modest arterial pressures have been reported by initial users at 30 days. The innovative lumen profile provides a large inner diameter to support high flow rates and improved kink resistance to ensure optimal clinical outcomes in tortuous vessels. 

Numerous additional features combine to maximise the innovative value of the DuraMax catheter:

• Highly robust luer fittings constructed of thermoplastic polyurethane combine chemical resistance and superior dimensional stability. 
• A rotating suture wing allows for patient comfort and provides flexibility to position the catheter tips. 
• A robust  polyester cuff material allows optimal tissue in growth and catheter securement. 

The DuraMax catheter is available in a full range of catheter lengths, including a 48cm length, in both basic kit and catheter only configurations.

Boston Scientific announced that the FDA has approved its Renegade HI-FLO Fathom Pre-Loaded system for selective access and delivery of diagnostic, embolic and therapeutic materials into the peripheral vasculature. The system will primarily be used by interventional radiologists for minimally invasive procedures to treat uterine fibroids and liver cancer.

“The excellent deliverability, torque transmission and flow capacity of the Renegade HI-FLO Fathom Pre-Loaded system provides physicians with the performance they need to efficiently access tortuous vessels across many types of interventional oncology procedures,” said Jeff Geschwind, director of Vascular and Interventional Radiology at the Johns Hopkins University School of Medicine, Maryland, USA. “Having the Fathom-16 Guidewire pre-loaded in the Renegade HI-FLO Microcatheter will reduce my procedural preparation time and the number of devices that my staff must manage.”

The Renegade HI-FLO Fathom Pre-Loaded system combines the turn-for-turn torque response, flexibility and high visibility of the Fathom-16 Steerable Guidewire with the clinically proven performance of the Renegade HI-FLO Microcatheter, pre-loaded in a single convenient platform. The system will be available in eight configurations to suit a broad range of peripheral embolization procedures.

“Adding the pre-loaded system to our product offerings demonstrates Boston Scientific’s commitment to providing a comprehensive suite of less-invasive solutions for interventional radiologists and their patients,” said Joe Fitzgerald, senior vice president and president of Boston Scientific’s Endovascular Unit. “We will continue to bring additional technologies to market that advance the various therapies performed by specialists in vascular and interventional radiology.”

Boston Scientific announced that the FDA has approved its Renegade HI-FLO Fathom Pre-Loaded system for selective access and delivery of diagnostic, embolic and therapeutic materials into the peripheral vasculature. The system will primarily be used by interventional radiologists for minimally invasive procedures to treat uterine fibroids and liver cancer.

“The excellent deliverability, torque transmission and flow capacity of the Renegade HI-FLO Fathom Pre-Loaded system provides physicians with the performance they need to efficiently access tortuous vessels across many types of interventional oncology procedures,” said Jeff Geschwind, director of Vascular and Interventional Radiology at the Johns Hopkins University School of Medicine, Maryland, USA. “Having the Fathom-16 Guidewire pre-loaded in the Renegade HI-FLO Microcatheter will reduce my procedural preparation time and the number of devices that my staff must manage.”

The Renegade HI-FLO Fathom Pre-Loaded system combines the turn-for-turn torque response, flexibility and high visibility of the Fathom-16 Steerable Guidewire with the clinically proven performance of the Renegade HI-FLO Microcatheter, pre-loaded in a single convenient platform. The system will be available in eight configurations to suit a broad range of peripheral embolization procedures.

“Adding the pre-loaded system to our product offerings demonstrates Boston Scientific’s commitment to providing a comprehensive suite of less-invasive solutions for interventional radiologists and their patients,” said Joe Fitzgerald, senior vice president and president of Boston Scientific’s Endovascular Unit. “We will continue to bring additional technologies to market that advance the various therapies performed by specialists in vascular and interventional radiology.”

Endologix, developer of minimally invasive treatments for aortic disorders, announced the publication of favorable clinical results of the Nellix technology for the endovascular repair of abdominal aortic aneurysm (EVAR). The peer-reviewed article, published in the February issue of the Journal of Vascular Surgery (JVS), reported initial results from the international multicentre clinical trial, with successful aneurysm exclusion in all patients, and no late aneurysm or device-related adverse events or secondary procedures.

Carlos E. Donayre, lead author and scientific advisor, Harbor-UCLA Medical Center, Torrance, USA, commented: “The Nellix technology was designed to address the limitations of currently available EVAR devices and to expand the therapy to more patients. By filling the aneurysm sac, the Nellix device may reduce the incidence of endoleaks, secondary interventions and the need for annual CT scan follow-up.”

The Nellix endoprosthesis consists of dual balloon-expandable endoframes surrounded by polymer-filled endobags designed to obliterate the aneurysm sac and maintain endograft position, features that help to address the anatomic restrictions and limitations of current endografts.

The study, entitled “Initial clinical experience with a sac anchoring endoprosthesis for aortic aneurysm repair,” examined the initial and one year outcomes of 21 patients treated at four international centres. An independent core laboratory analysed pre-operative and post-procedural computed tomography scans to determine aneurysm exclusion and device stability over time.

John McDermott, president and CEO, Endologix, said, “We believe the Nellix technology represents the next generation in endovascular repair of abdominal aortic aneurysms. Since completing the acquisition in December 2010, we are delighted that initial results of the international trial are now published by a peer review journal and we look forward to providing the clinical community with updates as more data is available. In addition to Nellix, our Ventana fenestrated stent graft and AFX system continue to advance on schedule. We believe this robust new product pipeline will enable us to expand the EVAR market.”

Results:

The endograft was successfully deployed in 21 patients with infrarenal aortic aneurysms measuring 5.7 ± 0.7 cm (range, 4.3-7.4 cm). Two patients with common iliac aneurysms were treated with sac-anchoring extenders that maintained patency of the internal iliac artery. Infusion of 71 ± 37mL of polymer (range, 19-158mL) into the aortic endobags resulted in complete aneurysm exclusion in all patients.

Mean implant time was 76 ± 35 minutes, with 33 ± 17 minutes of fluoroscopy time and 180 ± 81mL of contrast; estimated blood loss was 174 ± 116mL. One patient died during the postoperative period (30-day mortality, 4.8%), and one died at 10 months from non-device-related causes. During a mean follow-up of 8.7 ± 3.1 months and a median of 6.3 months, there were no late aneurysm-or device-related adverse events and no secondary procedures. CT imaging studies at 6 months and 1 year revealed no increase in aneurysm size, no device migration, and no new endoleaks. One patient had a limited proximal type I endoleak at 30 days that resolved at 60 days and remained sealed. One patient has an ongoing distal type I endoleak near the iliac bifurcation, with no change in aneurysm size at 12 months.

Hotspur Technologies announced that Guy Mayeda, interventional cardiologist at Good Samaritan Hospital in Los Angeles, California, USA, performed the first commercial deployment of its IQCath Balloon Dilatation Catheter. This new device enables, for the first time, performance of three complex vascular procedures with one single catheter, potentially reducing procedure time and expense for both patients and medical professionals.

“The IQCath brings much needed efficiency and innovation to dialysis graft revascularisation procedures. The ability to perform balloon angioplasty, embolectomy, local drug delivery, and angiography with a single device should shorten procedure times, as well as reduce radiation exposure to both the operator and patients,” said Mayeda.

The IQCath is a three-in-one device that allows physicians to perform high-pressure angioplasty, inject fluids such as contrast, and perform embolectomy while maintaining guidewire position.

During this procedure, Mayeda brought the 5mm balloon to its RBP of 16 atmospheres ten times and performed five intermittent contrast injections while utilising the same catheter. In the past, in these types of medical procedures, physicians typically have had to use multiple catheters to open the blood vessels, which can be time-consuming and expensive. Hotspur’s products enable insertion of only one catheter for the entire procedure.

The IQCath is one of Hotspur’s first three devices that have received 510(k) clearance from the FDA. These three new Hotspur devices are focused on solving some of the key challenges associated with restoring blood flow to blocked or low flow dialysis access grafts and fistulaes and peripheral vessels.

“We have heard from physicians that they need devices that are purpose-designed for the many peripheral access procedures they perform regularly, rather than having to repurpose a variety of legacy devices designed for other procedures,” said Gwen Watanabe, president and CEO of Hotspur. “We are committed to responding to this need and bringing high quality and efficient

devices to a very broad and currently underserved market.”

Watanabe indicated that, based on the company’s analysis, there are as many of 800,000 procedures performed annually that could benefit from this multi-purpose approach to catheter design for the peripheral access market.

In addition to the IQCath, Hotspur has also gained 510(k) clearance for two additional innovative balloon technologies. The GPSCath Balloon Dilatation Catheter follows the lead of the IQCath as a specialty two-in-one device that allows the physician to conduct angioplasty and inject fluid while maintaining guidewire position. Also, the Keeper Embolectomy Catheter is another two-in-one device which integrates an embolectomy balloon with the ability to inject physician-specified fluids while maintaining guidewire position.

These products are commercially available in the USA.

The Journal of Vascular and Interventional Radiology (JVIR)—the monthly, peer-reviewed flagship publication of the Society of Interventional Radiology—announced several major changes for 2011—all directed at highlighting the global impact of this minimally invasive medical specialty and its lead journal.

JVIR, which has been published since 1989, focuses on critical and cutting-edge medical, minimally invasive, radiological, pathological and socioeconomic issues of importance to vascular and interventional radiologists.

“Changes have been made to further enhance the Journal of Vascular and Interventional Radiology’s core strengths, particularly to streamline its editorial process. My target goal is 30 days for time to first decision for new manuscripts,” said new editor-in-chief Ziv J Haskal.

“JVIR is a vigorous engine for rapid peer review and delivery of the most novel and impactful, global, cutting-edge, basic science research, clinical reports and evidence-based medicine—JVIR aims to build on that legacy,” explained Haskal, who is also professor of radiology and surgery at the University of Maryland School of Medicine and vice chair of strategic development and chief of vascular and interventional radiology, image-guided therapy and interventional oncology at the University of Maryland Medical Center, both in Baltimore, USA.

JVIR’s new look includes a cover design that incorporates the title’s bold new logo, contemporary graphics and abstract angiographic images, while changes to the publication’s text style, image treatments and layout combine to provide enhanced readability.

“At a time when there is a growing demand for high-quality, evidenced-based work, JVIR delivers,” said James F Benenati, president of the Society of Interventional Radiology, interventional radiologist and medical director for the Noninvasive Vascular Laboratory at Baptist Cardiac & Vascular Institute in Miami, USA. “As interventional radiology expands globally, the time is right for new initiatives that will leverage the tools, technology and experience of SIR members,” Benenati continued.

“The combined expertise of the newly reconfigured JVIR editorial board—a smaller group of renowned associate editors—including a new deputy editor Tony P Smith—will ensure uniformity, fairness and efficiency in manuscript handling, comments and revisions,” said Haskal. Smith is a professor of radiology and division chief of peripheral and neurological radiology at the Duke University Medical Center in Durham, USA.

In keeping with JVIR’s vision for a stronger international focus, the new board includes interventional radiologists from the United States, Canada, India, Japan and Korea.

Study investigators have reported initial data from Cook Medical’s REFORM clinical trial that is aimed at assessing the safety and effectiveness of the company’s balloon-expandable renal stent for the treatment of renal artery stenosis. The data, presented by Robert Bersin, Seattle, USA, at ISET 2011, reveal a nine-month primary patency rate of 89.5% and a 97% rate of successful delivery and deployment of the stent.

“The data for the REFORM clinical trial reflect the clinical performance and patency of this dedicated renal stent platform,” said Bersin, the study’s principal investigator and medical director of endovascular services at Seattle Cardiology and Swedish Medical Center. “These initial data indicate the balloon-expandable stent may offer a new treatment option for patients suffering from renal artery blockages.”

One hundred patients were enrolled at seven investigative sites throughout the United States.  Initial data were compiled at nine months post-procedure and benchmarked against well-established performance data.

“We are pleased with the clinical data associated with this balloon-expandable renal stent,” said Rob Lyles, vice president and global leader of Cook Medical’s peripheral intervention division. “Cook will continue to pursue clinical improvements in peripheral stenting as part of our long-term mission to expand peripheral intervention to new classes of patients.”

Microsulis Medical Ltd will exhibit its Accu2i percutaneous microwave tissue ablation (pMTA) system for the first time at the forthcoming annual European Congress of Radiology in Vienna, Austria. From 4 to 7 March 2011, Microsulis will feature case studies from key centres using the system.

The Accu2i pMTA system, which is cleared for use in Europe, the United States and Canada, combines extreme ease of use with the widest range of clinical applications for rapid, precise coagulation of unwanted tissue masses, whilst avoiding the risks associated with longer, more invasive surgical interventions.

The device is a single high power high frequency 2.45GHz closed water-cooled microwave needle of 1.8mm diameter that can address tissue masses over 5cm in size in just six minutes, and is therefore between 3 to 10 times faster than other systems.  Its launch followed two years of extensive clinical use and evaluation in major centres around the world. Clinicians have used the device primarily in the treatment of liver and lung disease.

“Building on the momentum we have experienced in the first few weeks of 2011 with approval by Health Canada and the large order placed by our Italian distributor, MDH, we are looking forward to successfully demonstrating the Accu2i to an extensive range of European radiologists,” commented Stuart McIntyre, CEO of Microsulis.

“Increasing numbers of clinicians around the world are adopting the radically improved performance and ease of use of the Acculis system, moving away from older radiofrequency ablation systems.  With the successful use of the Accu2i pMTA system for the treatment of liver and lung disease worldwide, the device has been shown to be very versatile and able to address a wide range of soft tissue targets in the body.  Exhibiting at ECR will allow a broader audience to see the new Accu2i pMTA system and appreciate how the system sets a new benchmark, allowing them to treat more patients with more severe disease,” McIntyre added.

Flexible Stenting Solutions announced FDA investigational device exemption (IDE) approval for its FlexStent femoropopliteal self-expanding stent system on 2 February 2011.

The IDE allows Flexible Solutions to begin enrolment for the OPEN trial, a prospective, single-arm trial that will include up to 227 patients at up to 40 clinical sites in the United States. The study is scheduled to begin in the first quarter of 2011.

According to the company, the device is an atraumatic, highly durable, fatigue resistant stent with high radial strength. William A. Gray, principal investigator of OPEN, commented “This is a major milestone for the company and in combination with compelling early overseas data affords it the opportunity to further demonstrate the safety and efficacy of the product and ultimately lead to premarket approval here in the United States.”

Flexible Solutions previously announced that it has received FDA 510(k) clearance for the biliary FlexStent system.  In Europe, CE mark approval has been granted for the biliary and femoropopliteal FlexStent systems, which include the same stent delivery system to be used in the United States clinical study.

In a presentation titled “So what have I learned from the latest carotid trials?” Michael R Jaff, associate professor of Medicine Harvard Medical School, told delegates at the CX@LINC 2011 symposium that it never ceases to amaze him how physicians do not agree on the interpretation of results even when presented with the highest levels of scientific evidence, i.e., multicentre randomised clinical trials which have met their primary endpoint.

Jaff, who is also medical director, Vascular Center, Massachusetts General Hospital, Boston, Masachussets, USA, told delegates, “After all, CREST is a randomised multicentre trial done under the most stringent criteria with tremendous independent oversight, every step of the way. The predefined primary endpoint was agreed upon not only by the federal government in the USA and its steering committee, but by many national societies who care for patients with vascular disease. Before the first patient was enrolled, a vascular surgeon ran this trial. Ultimately, the primary endpoint was met. How could this be confusing? It should have settled the debate”, he insisted.

At the Leipzig Interventional Course 2011, Leipzig, Germany, Jaff told delegates that the current evidence showed that for a patient with carotid artery disease, carotid endarterectomy, when performed by skilled surgeons with an excellent track record, is an effective option, which may be more effective in older patients. Similarly, carotid artery stenting when performed by skilled interventionists is effective, and may be more effective in younger patients.” He also talked about a third option; medical therapy. “Medical therapy has not been tested specifically in the patients being considered for carotid revascularisation in a rigorous study. Comprehensive medical therapy must still be tested head-to-head with revascularisation, but the impact of medical therapy is likely improving,” he said.

Jaff pointed to the interim safety analysis of the International Carotid Stenting Study (ICSS) comparing carotid artery stenting with endarterectomy in patients with symptomatic carotid stenosis found that risks of any stroke (65 vs 35 events; HR 1·92, 1·27—2·89) and all-cause death (19 vs seven events; HR 2·76, 1·16–6·56) were higher in the stenting group than in the endarterectomy group. The ICSS safety analysis was published in The Lancet (March 2010) and investigators wrote in the interpretation that “Completion of long-term follow-up is needed to establish the efficacy of carotid artery stenting compared with endarterectomy. In the meantime, carotid endarterectomy should remain the treatment of choice for patients suitable for surgery.”

However, the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) results, published in May 2010 in NEJM, showed that on the composite primary end point of any stroke, myocardial infarction, or death during the periprocedural period or ipsilateral stroke on follow-up, stenting was associated with a 7.2% rate of these events vs. 6.8% with surgery, a non-significant difference.

So Jaff asked: “Why did CREST not settle the score?” He stated that the reason for this was that surgeons feel that carotid revascularisation is performed in order to prevent stroke. Carotid endarterectomy reduced the stroke risk more than carotid artery stenting did. Also, surgeons saw the excess myocardial infarction rate with carotid endarterectomy as “less of an issue”. On the other hand, Jaff pointed out that interventionists felt that CREST data showed that carotid artery stenting was performed as safely as carotid endarterectomy, and that the excess stroke risk was due to an increase in minor strokes only. They also felt that the myocardial infarction risk associated with carotid endarterectomy was important. Neurologists feel that although outcomes were low, medical therapy is more effective than any form of revascularisation.

The accompanying editorial in The New England Journal of Medicine published in May 2010 stated, “Though it appears that the increased risk of stroke with carotid-artery stenting is offset by an increased risk of myocardial infarction with carotid endarterectomy, stroke has greater long-term health consequences than myocardial infarction.” So, this is the issue, said Jaff.  Should myocardial infarction have been included as a component of the primary endpoint. Many physicians believe that the apparent equivalence of carotid artery stenting and carotid endarterectomy in the CREST results might be as a result of equating stroke with myocardial infarction  (both of which are in the composite primary end point) even though these may impact a patient’s life in very different ways.

Jaff also touched on the latest carotid artery stenting data available, which shed some light on the issue of operator experience which is critical to the success of either carotid artery stenting or carotid endarterectomy. “The major adverse events rate as shown by CASES PMS (Carotid Artery Stenting With Emboli Protection Surveillance–Post-Marketing Study) vs SAPPHIRE  shows that with short formalised training programmes, physicians with significant experience in carotid stenting can achieve similar short- and longer-term results to the highly experienced SAPPHIRE investigators. Published in the Journal of American College of Cardiology, this analysis shows that at one-year,  the results of carotid artery stenting with embolic protection carried out by operators of significant experience is equivalent to the results of carotid artery stenting carried out by experienced SAPPHIRE investigators and significantly better than outcomes with carotid endarterectomy.

“Can one actually predict the stroke risk in patients with asymptomatic carotid artery stenosis?” questioned Jaff. He referred to recent research which finds that for asymptomatic carotid disease, high-intensity transient signals (HITS) seen during transcranial Doppler assessment may be a significant marker of future stroke risk. Asymptomatic embolization for prediction of stroke in the Asymptomatic Carotid Emboli Study (ACES): a prospective observational study published in Lancet Neurology in 2010, shows that detection of embolic signals by transcranial doppler may identify groups of patients with asymptomatic carotid stenosis who are at high risk of future stroke. Authors report that this technique might be a useful risk predictor for identifying those patients who might benefit from intervention with carotid endarterectomy.

“I think what we have learned in the recent data is we have two excellent procedures to offer our patients with carotid disease. The debate should not be which one is necessarily better than the other, but rather which one is right for the individual patient now that we have this data,” he concluded.

Cerebral protection with a reverse flow system appears more effective at preventing brain injury than using filters or unprotected carotid artery stenting. The reverse flow system may offer a method of decreasing the frequency of minor strokes occurring during carotid artery stenting, research presented at the British Society of Interventional Radiology meeting found.

Stephen Goode, Sheffield Vascular Institute, Northern General Hospital, Sheffield, UK told delegates at the annual meeting of the British Society of Interventional Radiology in 2011 that following the recent publication of two large randomised clinical trials (ICSS and CREST), there is evidence to suggest that there is a higher risk of minor stroke following carotid artery stenting than endarterectomy, when predominantly filter protection is used.

“This increased risk may be due to increased embolization during the procedure. The aim of our pilot study was to assess the effectiveness of flow reversal as a means of cerebral protection in carotid artery stenting by looking at surrogate markers of brain injury.

Materials and methods:

The reverse flow system was used in 15 patients. MRI scans were performed pre- and three hours, 24 hours and 30 days post-intervention to assess for the presence and number of new ischameic lesions using diffusion weighted imaging. Transcranial Doppler recordings were made from the ipsilateral middler cerebral artery during the procedure to assess for microembolic signals. The data was analysed against a historical cohort of 15 unprotected and 15 filter protected patients, performed by the same operators.

Results:

There were less diffusion weighted imaging positive scans in patients undergoing reverse flow cerebral protection and a fewer diffusion weighted imaging lesions when compared to the filter protected and unprotected historical cohorts.

“We found fewer microembolic signals in patients undergoing reverse flow protected carotid artery stenting , and this was particularly noticeable during the stages of the procedure known to be prone to embolic events. There were 45 microembolic events with patients who had reverse flow protection, 80 microembolic events in the unprotected cohort and 138 events in the filter-protected group.

“The findings from this pilot study suggest that cerebral protection with a reverse flow system appears more effective than protection with a filter, or no protection at all, and we are planning a large, randomised trial comparing distal vs. proximal protection devices,” said Goode.

IDEV Technologies announced the release of two-year European data from the Leipzig Registry, which tracks patients treated with the Supera wire interwoven nitinol stent. The Supera stent is CE marked for biliary and peripheral vascular use in Europe. In the United States, this stent is currently being studied in an ongoing FDA approved IDE trial for treatment of peripheral arterial disease of the superficial femoral artery.

Results were presented by Sven Braunlich, Department of Angiology at Park Hospital and Heart Centre, Leipzig, Germany during the 2011 Leipzig Interventional Course (LINC). Key data points include a primary patency rate of 76% by duplex ultrasonography at two years with no stent fractures. The 12-month patency rate was 85%, and the 18-month patency rate was also 76%, showing stable patency from 18 to 24 months.

The single-centre registry includes data from 107 patients treated for peripheral arterial disease of the superficial femoral artery. Within the study population, about a third of the patients had occlusions, 17% were categorised as Rutherford 4 or 5, and another 82% were Rutherford 3. Additionally, half the treated lesions required placement of the Supera stent in the distal third of the femoral artery. These highly diseased patients, with severely calcified lesions, had an average treated lesion length of approximately 11 centimeters, nearly double that in other stent trials.

“The Supera stent has been shown in independent testing to be extremely crush and fracture resistant compared to standard nitinol stents. Combined with the flexibility of the interwoven design, it is very well suited for use in the challenging superficial femoral artery. X-ray screening, conducted at an average follow-up of 17 months, documented excellent durability of the stent in the superficial femoral artery, detecting zero fractures. In addition, there was statistically significant improvement in ankle brachial index and Rutherford scores at all follow-up time points. These represent important clinical benefits to patients, and may translate into fewer repeat procedures,” Braunlich said.

Kenneth Rosenfield, director of Cardiac and Vascular Invasive Services at Massachusetts General Hospital in Boston and co-principal investigator of the IDE trial commented, “The ongoing work at Leipzig, and the promising patency data reported in the Registry, helped establish the basis for the US superficial femoral artery trial. We are encouraged by the Registry results, and look forward to completing enrolment in the SUPERB clinical trial in the first half of 2011.”

Eric Dippel, from Cardiovascular Medicine, P.C. at Trinity Regional Health System in Davenport, Iowa observed during LINC, “This is the longest follow-up data available for a novel stent that shows sustained excellent results. I am very impressed with the durability in the 18- to 24-month window.”

The independent testing referenced by Braunlich reported zero stent fractures for any Supera stent tested after 10 million cycles of 120 degree flexion and extension and 20 million cycles of torsion. Additionally, compression testing demonstrated a minimum of four times the radial strength and 360% stronger crush resistance than standard nitinol stents. Throughout this testing, the stent completely resisted fracturing, kinking, crushing, and crimping. In comparison, all standard nitinol tubular stents tested fractured before 100 thousand cycles in the flexion and extension testing and before 1 million cycles in the compression load testing.

The Supera stent is currently indicated in the USA for the palliative treatment of biliary strictures produced by malignant neoplasms and in Europe for the treatment of biliary strictures produced by malignant neoplasms and for peripheral vascular use following failed percutaneous transluminal angioplasty.

Abbott announced that it has received CE mark for its Xience Prime everolimus eluting coronary stent system for the treatment of critical limb ischaemia or severe claudication of the lower leg. Data generated on Xience V drug eluting stent from the DESTINY trial supported the stent’s CE mark. DESTINY’s multicentre trial compared the Xience V drug eluting stent to Abbott’s bare metal stent, the Multi-link Vision, in 140 patients with claudication of the lower leg, with lesion lengths less than 40 mm.

“Treating a diseased vessel in the lower leg with an everolimus eluting stent has generated compelling clinical data compared to treatment with a bare metal stent, and we are confident that Xience Prime will become an important option for European physicians treating this critical disease.” said Robert Hance, senior vice president, Vascular, Abbott.

The 12-month results from DESTINY demonstrated that Xience V had significantly better patency compared to the Multi-link Vision bare metal stent at 12 months (85.2% Xience V versus 54.4% Multi-link Vision; p=0.0001). This difference was especially pronounced between six and 12 months, where the difference in patency rate significantly diverged, as the rate for the bare metal stent fell to nearly 50% while the rate for Xience V remained above 85%. These results demonstrated that there is a significant benefit from an everolimus eluting stent versus a bare metal stent. The data from DESTINY were presented at the Leipzig Interventional Course (LINC) held in Leipzig, Germany from 19 to 22 January 2011.

“The DESTINY trial demonstrates that everolimus eluting stents result in significantly better patency at 12 months compared to bare metal stents for patients with critical limb ischaemia of the lower leg, and the use of everolimus eluting stents can potentially provide significantly better outcomes for these patients,” said Marc Bosiers, head of the Department of Vascular Surgery at St. Blasius Hospital in Dendermonde, Belgium, and principal investigator of the DESTINY trial. “A drug eluting stent such as Xience Prime provides European physicians with another treatment option for patients with short lesions in the lower leg.”

A tiny ultrasound device that helps dissolve blood clots is showing promise in breaking up potentially deadly pulmonary embolisms. Research on the largest group of patients treated with this method was presented at the 23rd annual International Symposium on Endovascular Therapy (ISET) held in Miami from 16 to 18 January 2011.

“This method may revolutionise the way we treat patients with large pulmonary embolisms,” said Tod Engelhardt, chairman of the Cardiovascular and Thoracic Surgery Division at East Jefferson General Hospital, and assistant professor of Surgery at Tulane University School of Medicine in New Orleans. “These are patients who were saved and prevented from going into heart failure.”

In the study, 27 patients with significant pulmonary embolisms were treated at East Jefferson General Hospital in Metairie, Los Angeles, USA. All survived and each benefitted from a significant reduction in right heart chamber size. On average, the size of each clot was reduced by more than half. Four patients suffered from major bleeding and two from minor bleeding. There were no bleeding complications in patients who received a lower dose of clot-busting drugs.

In traditional therapy, clot-busting drugs are delivered to the blockage, but the method can take many hours or even days. In the ultrasound method, the device is advanced through blood vessels to the site of the blockage, where it emits sound waves that loosen the clot, allowing the clot-busting drugs to dissolve it faster. The method currently is used to treat deep vein thrombosis.

Stents can open up blocked brain arteries after other stroke treatments have failed, according to research being presented at the 23rd annual International Symposium on Endovascular Therapy (ISET) held in Miami from 16 to 18 January 2011.

In research conducted at the Baptist Cardiac & Vascular Institute in Miami, USA, stents were placed in the blocked brain arteries of 19 acute stroke patients who had not been helped by clot-busting drugs or clot-removal devices. The stents opened up the arteries in 18 of the 19 (95%) patients, and this resulted in 12 (63%) who had minimal or no deficits. Five patients (26%) died from major strokes.

“If stents had not been used to restore blood flow after these serious strokes, mortality or severe disability would have occurred in approximately 80 to 90% of patients,” said Italo Linfante, director of Endovascular Neurosurgery at the Institute. Currently, using stents to treat acute stroke is an experimental procedure of last resort, used when all other methods have failed. Approved treatments include breaking up the clot with drugs, removing it with a corkscrew-like device and vacuuming it out.

“FDA-approved treatments to restore blood flow in acute ischemic stroke work 40 to 60% of the time. If the artery remains blocked, the patient will suffer death or severe disability,” said Linfante. “Our findings suggest stents can work when clot busting-drugs and clot-removal devices do not, and are a safe and feasible option.”

Stents have long been used preventatively to open up clogged heart and neck arteries to thwart stroke and heart attack. Scientists have recently discovered that stents may also be used as a treatment device, meaning doctors place them in blocked arteries to treat heart attacks and strokes.

Multiple sclerosis patients may get some relief from severe fatigue from an experimental procedure to open blocked blood vessels in the chest and neck showed preliminary Stanford University research presented at the 23^rd annual International Symposium on Endovascular Therapy (ISET) held in Miami from 16 to 18 January 2011.

A year after doctors used either angioplasty or stents to open blocked veins of 30 multiple sclerosis patients, they suffered about half the fatigue, on average, than they had before the treatment, according to data presented by Michael Dake, professor in the Department of Cardiovascular Surgery at Stanford University, School of Medicine, Stanford, USA. Patients with the most common type of multiple sclerosis— relapsing-remitting—benefitted most.

Treatment for chronic cerebrospinalvenous insufficiency is controversial, with some doctors doubting the existence of the condition. Stanford and the Baptist Cardiac & Vascular Institute in Miami, plan to begin a trial in 2011 to assess the condition and treatment with angioplasty. “If a person has multiple sclerosis and has a blood vessel obstruction, and if it is removed, we will look at whether we can we demonstrate objectively that there is improvement in blood flow,” Dake said.

The ISET meeting featured several presentations on chronic cerebrospinalvenous insufficiency. Among the speakers was Paolo Zamboni, University of Ferrara, Italy, a vascular surgeon who first proposed and is now testing the theory, also James F Benenati, president of the Society of Interventional Radiology.

Zamboni theorises that abnormal blood flow can damage the nervous system and lead to chronic cerebrospinalvenous insufficiency. He reported initial results in 2009, suggesting the existence of chronic cerebrospinalvenous insufficiency and that endovascular treatment relieved some multiple sclerosis symptoms and improved quality of life in certain patients.

Medtronic announced the complete acquisition of Ardian a developer of catheter-based therapies to treat hypertension and related conditions.

Under the terms of the agreement announced on 22 November 2010, the purchase price is US$800 million in cash up front, plus additional cash payments equal to annual revenue growth through the end of Medtronic’s fiscal year 2015.

Medtronic held an 11.3% ownership in Ardian, prior to completion of the acquisition, and expects to recognise gain on its ownership stake of approximately US$80 million, which will be partially off-set by one time transaction and acquisition costs in fiscal year 2011.

Acquiring Ardian offers Medtronic the opportunity to lead the development of renal denervation for the treatment of uncontrolled hypertension. The Symplicity catheter system, Ardian’s CE marked flagship product addresses this anomaly through renal denervation, or ablation of the nerves lining the renal arteries.

Ardian’s acquisition augments Medtronic’s existing interventional therapies and complements the company’s expertise in catheter design and ablation technologies.

Y90: Are You Ready? is an intensive course examining radiation biology, dosimetry, radiation safety, embolotherapy and clinical office management in the use of Yttrium-90 in the treatment of liver tumors. The course will be held from 10 to 13 February 2011 in Scottsdale, Arizona, and is organised by the Society of Interventional Radiology.

Participants will be able to explore the development of hepatic artery radioembolisation devices, compare and contrast current and future device platforms, determine trends in patient selection and outcome prediction, review information on the treatment algorithm and discuss the rationale for the two-stage delivery approach and describe best practice in Y90 radiation safety and dose management.

“Interventional radiologists have been at the forefront of the research and development of Y90; there is now clear rationale for a comprehensive course on this evolving therapy. IR trainees, researchers, medical and radiation oncologists and IR technologists/nurses will gain from this most in-depth and challenging curriculum available for clinical teams interested in initiating or enhancing their practice in this area of interventional radiology,” noted Riad Salem, professor of radiology, medicine and surgery, director of interventional oncology at Northwestern University, Chicago and programme co-ordinator.

Besides Salem, programme coordinators include Matthew S. Johnson, professor of radiology and surgery and director of Interventional Oncology at Indiana University, School of Medicine and Brian F. Stainken, adjunct professor at Boston University and chair of the Diagnostic Imaging department at Roger Williams Medical Center.

For more information and registration visit: www.sirweb.org/meetings/SIR_Y90.shtml or phone (703) 691-1805. The registration ends on 12 January 2011.

Boston Scientific announced on 10 January 2011 that it has completed enrolment in the ORION clinical trial, which is designed to evaluate the company’s Epic self-expanding nitinol stent system for the treatment of iliac artery disease. The trial will examine rates of device- and/or procedure-related major adverse events and patency rates at nine months in 125 patients at 28 sites in the USA.

“We are pleased to complete the enrolment phase of this important trial,” said Daniel Clair, chairman of the department of Vascular Surgery, The Cleveland Clinic Foundation, and principal investigator of the trial. “Peripheral stenting has become a recognised standard in the treatment of iliac artery disease, and the ORION trial will provide important data on the performance of the Epic Stent in treating these types of lesions,” explained Clair.

The next-generation Epic stent is a self-expanding nitinol stent designed to sustain vessel patency, while providing enhanced visibility and accuracy during placement. The ORION trial incorporates stent diameter ranges from six to 12mm and lengths up to 120mm. All stent sizes are compatible with 6F (2.1mm) sheaths, and the stent delivery system is compatible with 0.035 inch (0.89mm) guidewires.

“We are encouraged by the success of our Epic stent since its European approval and launch in early 2009, and we look forward to its approval in the USA based on results from this trial,” said Joe Fitzgerald, senior vice president and president of Boston Scientific’s Endovascular Unit.

The Epic nitinol stent system is an investigational device and is limited by applicable law to investigational use only and is not available for sale in the USA.

The workshop brought together 143 medical directors, Strategic Health Authority (SHA) and Primary Care Trust (PCT) commissioners and Trust radiology clinical directors and managers to discuss the uneven provision of interventional radiology services across the country. Sir Bruce and the expert faculty revealed findings on how services can be improved for patients through a new roadmap document for hospitals. “I hope that this conference proves a spur to action,” Sir Bruce said.

The event, hosted by NHS Improvement, saw the unveiling of the roadmap document Interventional Radiology: Improving quality and outcomes for patients – a report from the National Imaging Board’ which is available on the Department of Health website (www.dh.gov.uk). 

This follows on from a project launched by Sir Bruce and Sir David Nicholson, chief executive of the NHS in England and led by Erica Denton, national clinical director for Imaging, Department of Health, which explored barriers to the expansion of interventional radiology services and detailed recommendations on what actions commissioners and Trusts can take to overcome them.

The event was well received with further discussions now underway to move the project forward. Lesley Wright, director of Diagnostics at NHS Improvement, said: “NHS Improvement will be supporting this programme by working with a number of sites to improve their services and showcase their excellent practice.”

The next phase of work will continue in 2011 and includes a network of demonstration sites and service improvement projects with local Trusts, as well as further work to ensure that interventional radiology requirements are reflected in workforce and training improvements and the economic benefits realised.

On November 15, 2010 AngioScore initiated a worldwide recall of the AngioSculpt PTA Scoring Balloon Catheter, 0.018” over the wire with balloon sizes: 4.0x20mm, 5.0x20mm, and 6.0x20mm.

This recall was initiated because of a small number of reports from the field of distal bond failure which has resulted in peeling of the bond and/or detachment of the distal end of the scoring element, wherein the proximal end of the scoring element remains secured to the catheter.

 Retained device fragments or significant arterial injury due to device failure may occur which may lead to death, need for percutaneous catheter-based interventions to remove retained device fragments, increased exposure to anesthesia, and loss of limb. There have been no reported injuries related to this failure mode to date.

The company estimates that 14,775 affected products have been distributed in the United States and 2,907 affected products have been distributed outside the United States. FDA has classified this action as a Class I recall, meaning that FDA believes the use of this product may cause serious adverse health consequences or death.

This voluntary recall does not affect the AngioSculpt PTCA catheters, or any AngioSculpt PTA catheter balloon sizes (in millimeters): 0.014” over the wire, 2.0×10, 2.0×20, 2.5×20, 3.0×20, 3.5×20; and 0.018” over the wire, 4.0×40, 5.0×40, 6.0×40.

AngioScore has notified the hospitals that have received the recalled product and has instructed these hospitals to cease the use of affected product and return the affected product to AngioScore.

The firm voluntarily recalled the products after observing the failure modes during bench top testing. The FDA has been apprised of this action.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Online:www.fda.gov/medwatch/report.htm
• Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form. Fax: 1-800-FDA-0178

Consumers with questions may contact AngioScore at 1-877-264-4692, Monday through Friday from 8:00 am to 5:00 pm pacific time.

Terumo Interventional Systems has announced the full commercial availability in the United States of the Azur Peripheral HydroCoil 35 platinum coil embolization system. The Azur is a detachable hydrogel polymer embolic device with 0.035-inch coils and is compatible with 0.038-inch lumen catheters.

According to the company, the detachable Azur 35 is intended to reduce or block the rate of blood flow in vessels of the peripheral vasculature. It is designed for use in the interventional management of arteriovenous malformations, arteriovenous fistulas, aneurysms, and other lesions of the peripheral vasculature. The device’s design provides greater filling capacity, packing density, and mechanical occlusion particularly in the treatment of high-flow and challenging blood vessels, vascular malformations, and aneurysms.

Terumo stated that the hydrogel coating undergoes limited expansion within the first three minutes, and fully expands within 20 minutes. The Azur deploys rapidly and provides flexibility to position and observe the behavior of the coil in the vasculature before detachment. The device can be retracted and repositioned until it is securely placed, reducing the risk of nontarget embolization and coil migration. The microporous expandable hydrogel is biologically inert and provides scaffolding for natural tissue proliferation, the company added.

“In our experience, the Azur detachable 35 is an excellent embolization system that is very capable of treating higher capacity lesions with fewer coils, while effectively minimising risk of coil migration,” commented Craig Greben. “The larger coil size is highly deliverable and provides us with added confidence in treating high-blood flow areas or particularly challenging anatomies.”

Court orders destruction of Taeyeon Medical kyphoplasty product stock and manufacturing equipment.

Medtronic has announced that the High Court in Seoul, Korea has found that the balloon kyphoplasty device made by Taeyeon Medical infringes a valid Medtronic patent and has ordered destruction of Taeyeon’s stock of the infringing device and related manufacturing equipment.

“We are pleased by the High Court’s ruling,” said Alex DiNello, vice president and general manager of the Kyphon Products Division of Medtronic, which markets Kyphon Balloon Kyphoplasty for the treatment of vertebral compression fractures.  “We have solid patents protecting our kyphoplasty products, and we are committed to vigorously defending our intellectual property.”

Taeyeon brands impacted by this legal decision are Typhoon and Balex. The product and manufacturing equipment destruction order was enforced on October 12, 2010 by bailiffs of the Korean court.Taeyeon is appealing the decision to the Korean Supreme Court.

Court orders destruction of Taeyeon Medical kyphoplasty product stock and manufacturing equipment.

Medtronic has announced that the High Court in Seoul, Korea has found that the balloon kyphoplasty device made by Taeyeon Medical infringes a valid Medtronic patent and has ordered destruction of Taeyeon’s stock of the infringing device and related manufacturing equipment.

“We are pleased by the High Court’s ruling,” said Alex DiNello, vice president and general manager of the Kyphon Products Division of Medtronic, which markets Kyphon Balloon Kyphoplasty for the treatment of vertebral compression fractures.  “We have solid patents protecting our kyphoplasty products, and we are committed to vigorously defending our intellectual property.”

Taeyeon brands impacted by this legal decision are Typhoon and Balex. The product and manufacturing equipment destruction order was enforced on October 12, 2010 by bailiffs of the Korean court.Taeyeon is appealing the decision to the Korean Supreme Court.

Medtronic has announced the European launch of the new Kyphon Express Curette for scraping or scoring bone in the spine, including during treatment of vertebral compression fractures with minimally invasive Kyphon balloon kyphoplasty.

The Kyphon Express Curette is designed to maximise control when scraping or scoring bone in the spine. This product is available in T-tip with a torque resetting device, which allows easy resetting of the device when the tip encounters excess torsion.  It is compatible with the Kyphon Express access tools offering. 

This new product is a continuation of the industry-leading advancements Medtronic has made over the past 10 years in the treatment of vertebral compression fractures – the most common osteoporotic fractures coming to clinical attention with an estimated 1,400,000 spinal fractures worldwide every year. Left unrepaired, spinal fractures can cause additional health problems that increase the risk of mortality.

“As the leader and inventor of Kyphon Balloon Kyphoplasty, Medtronic is committed to the continued advancement of this important and specialized treatment to ensure the best outcomes for patients who suffer from debilitating spinal fractures,” said Alex DiNello, vice president and general manager of the Kyphon Products Division. “Since we introduced balloon kyphoplasty in 2000, an estimated 800,000 fractures have been treated worldwide with Kyphon balloon kyphoplasty by approximately 14,500 trained spine specialists.”

The launch of the new Kyphon Express Curette comes two months after the introduction of the Kyphon Cement Delivery System  in Western Europe on September 15, 2010 at Eurospine.  This system allows for the controlled delivery of bone cement at a safer distance with a one‰Ûhanded operation, preserving some tactile feel during delivery with the ability to halt bone cement flow on demand with the quick‰Ûrelease button.

The Kyphon Express Curette was launched in the United States in October 2010.

Visitors to the Radiological Society of North America Annual Meeting in Chicago, Nov. 28-Dec. 2,  saw the company’s latest innovations designed to enhance visualisation and improve workflow and dose efficiency, enabling interventional radiologists to see their way clearly when performing procedures addressing vascular diseases.

According to the American Heart Association, peripheral arterial disease affects about 8 million Americans and is associated with significant morbidity and mortality. And based on current epidemiologic projections, 27 million people in Europe and North America have the disease.

The most common procedures performed to treat peripheral arterial disease involve inserting guidewires and catheters into the patient’s circulatory system for angioplasty and stenting. More and more, complex interventions such as aortic aneurysm are treated with endoscopic methods. Just a few years ago, these procedures were done almost exclusively with X-ray fluoroscopy alone, while the physician injected contrast materiel to see the vessel that was being treated.

Today, images of the vessels taken with CT or MR and processed into 3D image data can provide both precise measurements of the vessels for planning and a clear map of the vessel anatomy. Combined with new applications offered by interventional x-ray systems, this is having a profound impact on how vascular procedures are performed.

GE Healthcare Interventional Systems provide a portfolio of solutions to address the needs in the interventional vascular disease management. The solutions range from X-ray imaging systems to advanced applications tailored for the specific vascular disease state needs.

The Innova 4100IQ is a comprehensive X-ray imaging solution that gives interventional radiologists the tools they need to take image-based diagnosis and minimally invasive therapy to a higher level.  Well suited for a wide range of procedures including peripheral, oncological and neurological imaging, the systems are infused with advanced software applications that not only provide precise anatomical detail, but also help simplify and expedite even the most complex and challenging diagnostic and interventional procedures. Innova 4100IQ has one of the largest detectors in the industry, which is a key advantage for complex endovascular procedures. Innova’s inherently dose efficient technology, dose reduction features and dose management tools help protect patients and physicians from radiation exposure without compromising the image quality physicians need to make confident decisions during interventional procedures. Independent studies have shown that patient case doses using Innova systems were 22-34% lower compared to the other flat panel detector systems tested.

The GE Advantage Workstation VolumeShare is a multi-modality platform that takes image visualisation and analysis to a new level of understanding and efficiency. Its unique Integrated Registration feature, crucial for vascular procedures, registers and fuses 3D anatomical and functional images from Innova, CT, MR, PET and SPECT, providing complementary information to plan guide and assess interventional procedures. Processing, integration and image overlay are achieved on a single workstation, with a single convenient user interface.

Innova Vision is an advanced application that allows physicians to dynamically overlay 3D models from Innova, CT or MR on top of 2D fluoroscopic images. The fusion is automatically maintained whenever the physician moves the C-arm or the table, bringing procedure workflow and confidence to a new level. Dedicated rendering and fusion algorithms provide optimal simultaneous visualisation of both 2D X-ray and 3D information. Innova Vision is able to overlay multiple 3D models on the same fluoro image, which is of particular interest for complex Endovascular Aortic Repair procedures.

“Thanks to excellent visualisation of the 3D model in fluoro, we have a better understanding of the 3D anatomy and where we are going – we see exactly where we are at all times,” said  Thierry de Baere, Institut Gustave Roussy (IGR), Villejuif, France.

Innova Vision includes the patented BackView Display, which allows the users to visualise the vessels or structures that are occluded by other vessels or structures. Users can simply rotate the 3D images by 180° to visualise either the front view or the back view of vascular anatomy, instead of re-acquiring the image after 180 degree of C-arm rotation. It is particularly useful when navigating through complex arterial trees and is of particular relevance for complex stenting interventions.

Vessel Tracking on Innova 3D Volumes enables fast tracking of the vessels centerline and display of lumen, curved, and cross section views. These views are optimal for visualisation of plaque and for measurement of vessel length and diameter.

Registry results confirm the excellent sealing performance of Angio-Seal vascular closure devices in interventional radiology procedures.

St Jude Medical commends the efforts of the investigators in the CIRSE Vascular Closure Device Registry, the world’s first multicentre registry aimed at assessing the performance of vascular closure devices in interventional radiology procedures.

With more than 1,100 patients enrolled at 28 centres in 10 European countries, the CIRSE registry validated the routine use of Angio-Seal vascular closure devices in interventional radiology, with successful deployment achieved in approximately 97% of procedures. The registry was conducted under the leadership of principal investigator Jim A Reekers, professor of interventional radiology at the University of Amsterdam, The Netherlands, and confirmed that the use of Angio-Seal vascular closure devices in IR procedures is safe and effective with low incidence of serious complications.

“The CIRSE Vascular Closure Device Registry results provide physicians with an unbiased source of information that verifies the benefits of closure devices in interventional radiology procedures,” Reekers said. “The results offer strong clinical data that demonstrate the use of Angio-Seal vascular closure devices are safe and effective with outstanding deployment success rates.”

The Angio-Seal vascular closure device platform is designed to enable physicians to quickly and effectively seal femoral artery punctures made during minimally invasive catheter-based procedures.

Effectively sealing the puncture helps achieve haemostasis (cessation of bleeding) quickly, enabling the patient to walk and resume activities sooner than with manual compression.

Since its introduction to the market 15 years ago, more than 15 million Angio-Seal vascular closure devices have been utilised around the world. In addition, more than 325 studies have documented the potential benefits of Angio-Seal devices for physicians, patients and hospitals.

“This registry once again confirms the exceptional safety and efficacy profile of Angio-Seal, and adds to previous studies that have indicated increased lab efficiency, reduced procedural cost and improved patient outcomes as a result of the use of this technology,” said Frank Callaghan, president of the St Jude Medical Cardiovascular Division. “St Jude Medical is pleased to see the benefits of our Angio-Seal vascular closure device reinforced by the results from the CIRSE registry, and we anticipate that these results will encourage the use of our Angio-Seal vascular closure device platform in IR procedures.”

Microsulis Medical Limited has announced that the first patient from the USA was treated with the company’s Accu2i percutaneous microwave tissue ablation (pMTA) system. The Accu2i pMTA system, which is now in worldwide distribution, is indicated for the coagulation of soft tissue during surgical procedures and recently received US Food and Drug Administration (FDA) clearance.

The procedure involved a patient with hepatocellular carcinoma, or primary liver cancer, and was performed by N Joseph Espat, professor and chief, surgical hepatobiliary oncology at Roger Williams Medical Center, Boston University. During the procedure, Espat combined microwave ablation using the Accu2i pMTA system of one 3cm tumour with surgical resection of two additional tumours.

“The device performed beyond my expectations  it was faster and better than the previous MTA system,” said Joseph Espat, professor and chief, surgical hepatobiliary oncology at Roger Williams Medical Center, Boston University. “The pMTA system is easier to handle and the diameter of the antenna makes it very safe. The tumour ablation was more rapid and efficient as compared to any other monopolar RFA system I’ve used previously. I’m pleased that Roger Williams Medical Center continues to be a technology leader for the treatment of patients with complex liver tumours.”

“We are delighted to report the first pMTA case in the United States and consider it a milestone in providing a sophisticated, fast and effective method for ablating unwanted tissue masses,” said Stuart McIntyre, CEO of Microsulis Medical Limited. “Current RFA and microwave systems have proven to have certain limitations when it comes to treating large and numerous cancerous tumours. With the Accu2i, surgeons can now perform larger and faster ablations that are suitable and less invasive for a broader group of patients.”

Historically, treatment options for liver cancer have included one or a combination of treatments including surgical removal of the cancer, chemotherapy, radiofrequency ablation (RFA), or radiation therapy. Ablative therapies, which aim to destroy tumors in-situ, are limited by the number and size of the tumours that can be targeted, therefore eliminating them as an option in many cases due to the limited performance of existing RFA and microwave systems. However, the Acculis Accu2i pMTA system is the first high power 2.45 GHz system that enables larger and faster ablations to be performed. This means that ablative therapy will now be available as an option for many more patients.

IDEV Technologies, Incorporated (IDEV), an innovative leader in the development and commercialization of minimally invasive medical technologies, today announced the first procedure in the United States utilising the Supera Veritas Transhepatic Biliary System, which was recently cleared to market by the USA  Food and Drug Administration.

The Supera Veritas wire interwoven nitinol stent is currently cleared in the USA for palliative treatment of biliary strictures produced by malignant neoplasms. Biliary strictures involve a narrowing of the bile duct, the body’s transportation system for fluid that is an essential aid to the digestion of food. Stents are commonly used to re-open the bile duct and restore the natural flow of fluids.

Mark Garcia, chief of Interventional Radiology at Christiana Care Health System in Newark, Delaware, is the first physician in the USA to treat a patient’s biliary stricture with the new Supera Veritas system. “The Supera’s high radial strength is uniquely suited for treating biliary strictures. Because of its characteristics, I have deployed a number of Supera stents over the past year. This new delivery system worked flawlessly. The driving mechanism was smooth and very responsive. The post-procedure images revealed optimal stent placement with excellent cholangiographic results and patency. I am very pleased with the result.”

“We are thrilled to get positive feedback on the initial deployment of the Supera Veritas system in the USA,” said Christopher M Owens, president and CEO of IDEV. “The US experience mirrors that of our customers in Europe and Canada, where the Supera Veritas system has been in use for the past year. The stent’s radial strength and flexibility combine to produce extremely high fracture resistance, and may redefine how patients are treated.”

Full commercial launch of the Supera Veritas Transhepatic Biliary System is planned for the first quarter of 2011.

The agreement calls for Medtronic to make an upfront cash payment of $800 million, plus commercial milestones equal to the annual revenue growth through the end of Medtronic’s fiscal year 2015. Medtronic had previously invested in Ardian and currently holds an 11% ownership stake in the Company. Based in Mountain View, California, Ardian develops catheter-based therapies to treat hypertension and related conditions.

“Hypertension is the leading attributable cause of death worldwide. It is a significant, escalating global healthcare problem affecting approximately 1.2 billion people and is associated with an increased risk of heart attack, stroke, heart failure, kidney disease and death,” said Sean Salmon, vice president and general manager of the Coronary and Peripheral Business at Medtronic. “We view renal denervation for the treatment of uncontrolled hypertension as one of the most exciting growth markets in medical devices. Ardian’s investigational catheter-based treatment for uncontrolled hypertension through renal nerve denervation complements Medtronic’s expertise in catheter design and ablation technologies, and augments Medtronic’s interventional therapies.”

Data from a clinical study of Ardian’s flagship product, the Symplicity Catheter System, were recently released at the American Heart Association 2010 Scientific Sessions in Chicago and published in The Lancet. It was reported that patients treated with the Ardian device experienced a 33 mmHg greater reduction in systolic blood pressure at six months (p<0.0001) than the control group. The Symplicity Catheter System has received CE mark and Australia TGA listing, but is not approved for sale in the USA.

“Ardian brings to Medtronic the Symplicity Catheter System and a growing body of evidence to support its clinical use for patients whose hypertension remains uncontrolled despite optimal medical management,” said Andrew Cleeland, president and CEO of Ardian. “Our integration into Medtronic creates a tremendous opportunity to leverage Medtronic’s global scale and scope to advance the treatment of uncontrolled hypertension.”

The transaction is expected to close in Medtronic’s third fiscal quarter of 2011, and is subject to customary closing conditions, including USA and foreign regulatory clearances.

Eurocor GmbH announced have launched Freeway, the latest second-generation, percutaneous transluminal angioplasty (PTA) balloon technology designed for the treatment of critical limb ischaemia associated with peripheral arterial disease (PAD).

Primary amputation rates amongst patients with critical limb ischaemia can be as high as 40% [Norgren, 2007] and the addition of Freeway technology provides interventionalists with an option that avoids amputation and could save up to $50,000 per patient per year [Pharmiweb, 2004].

“The introduction of Freeway arms us with another vital tool in the fight against peripheral arterial disease. It opens a new window of opportunity to treat many patients who may otherwise lose a limb” said Karl-Ludwig Schulte of Evangelisches Krankenhaus Königin Elisabeth in Berlin, Germany. Drug-eluting balloon technology has advanced the treatment of acute coronary syndromes and coronary artery disease and the extension of the technology to peripheral interventions will help reduce the incidence of restenosis following treatment.

Freeway, the latest drug-eluting technology from Eurocor, uses the same technology as Eurocor’s Dior paclitaxel-coated coronary balloon but applies it to a new patient population – those with critical limb ischaemia as a result of PAD. Eurocor’s drug-eluting balloon technology utilises a shellac film impregnated with paclitaxel, which is released whenever the balloon is expanded. This inhibits the proliferation of smooth muscle cells, and may prevent restenosis by preventing microtubule formation and inhibiting cell division and migration.

Preclinical studies with Freeway have shown a reduction in neointimal injury and a uniform drug distribution within the arterial wall. Early clinical experiences suggest the technique reduces rates of restenosis in patients undergoing angioplasty of femoro-popliteal arteries, with no additional adverse events. Phase III trials evaluating the prevention of restenosis in patients with peripheral arterial occlusive disease are underway and will be reported soon.

Over 70 international interventionalists and investors gathered at the Crowne Plaza St James hotel in London to hear the latest data on Eurocor’s portfolio of stent technologies. Topics discussed included the application of DEBs for cardiovascular interventions and the opportunity for utilising drug-eluting balloons in peripheral applications. “This meeting has given us the opportunity to learn more about the practical application of our products and gives us the opportunity to learn directly from the clinicians who are using them. The relationship between Eurocor and clinicians is vital for the continuing development of innovative medical devices for coronary and peripheral interventions” said Katja Hausner, director of Business Affairs at Eurocor, Bonn, Germany.

New data presented at the American Heart Association scientific sessions show that renal denervation significantly reduces blood pressure in patients with treatment-resistant hypertension.

Murray Esler, Baker IDI Heart and Diabetes Institute, Melbourne, Australia, presented results from the Symplicity HTN-2 Trial. The results were simultaneously published online in The Lancet. 

Elser told delegates that “Activation of renal sympathetic nerves was key to the pathogenesis of essential hypertension.”

Investigators set out to assess effectiveness and safety of catheter-based renal denervation for reduction of blood pressure in patients with treatment-resistant hypertension.

Symplicity HTN-2 is a multicentre, prospective, randomised trial. Between June 9, 2009, and Jan 15, 2010, Elser et al randomised 106 patients who had a baseline systolic blood pressure of 160mmHg or more (≥150 mm Hg for patients with type 2 diabetes), despite taking three or more antihypertensive drugs in a one-to-one ratio to undergo renal denervation (n=52) with previous treatment or to maintain previous treatment alone (control group, n=54) at 24 participating centres. The primary effectiveness endpoint was change in supine office-based measurement of systolic blood pressure at six months. Primary analysis included all patients remaining in follow-up at six months.

Forty nine (94%) of 52 patients who underwent renal denervation and 51 (94%) of 54 controls were assessed for the primary endpoint at six months. Investigators found that office-based blood pressure measurements in the renal denervation group decreased by 32/12mmHg (+/- 23/1mmHg, baseline of 178/96mmHg; P <.0001) but did not differ from baseline values in the control group (change of 1/0mmHg [+/- 21/10], baseline of 178/97mmHg; P =.77 systolic and P =.83 diastolic).

Between-group differences in blood pressure at six months were 33/11 mm Hg (P <.0001).

At six months, 84% of the subjects receiving renal denervation had a decrease in systolic blood pressure of 10 mm Hg or more versus 35% of 51 controls (P <.0001).

There were no major procedure-related or device-related complications. One patient who had renal denervation had possible progression of an underlying atherosclerotic lesion, but required no treatment.

There were no changes in measured renal function with denervation, which suggests that the procedure itself and associated haemodynamic changes have no deleterious effects on the kidneys.

Jon G Moss, professor, Department of Radiology, North Glasgow University Hospitals, Glasgow, UK spoke to Interventional News on the opportunities that renal denervation might represent to practitioners of a specialty whose territory other specialties regular poach on.

The technique involves use of radiofrequency energy from within the renal artery to block conduction in the surrounding renal nerves, thereby counteracting chronic activation of the sympathetic nervous system. In addition to blood pressure reduction, this treatment has shown promising results for chronic kidney disease, insulin resistance and heart failure.

Why is there so much attention being paid to renal denervation?

Up to a third of the population is hypertensive. Uncontrolled or difficult to control hypertension represents about 10–15% of these. If this new treatment works, then a large number of patients could benefit. If this can be shown to reduce the number of major vascular events such as myocardial infarction and stroke, then we are certainly onto something big and important for healthcare systems in developed countries. Furthermore, a reduction in sympathetic nerve activity may have an impact on renal function, sodium retention, heart failure and other disease entities.

Why does this new procedure represent such an opportunity for interventional radiologists?

Interventional radiologists are the obvious players here. They have years of experience of catheterising renal arteries, and more recently using radiofrequency ablation in various organs such as the kidney and liver. Furthermore there is already a natural referral pathway between blood pressure physicians and interventional radiologists through renal artery stenosis and hypertension.

 Interventional radiology can sometimes feel under pressure with aggressive groups from other specialties “chewing at its underbelly”. This has resulted in several “doors” closing off in some countries, for example EVAR in Australia. Other doors might close because of a lack of evidence— or example, renal stenting for hypertension. However doors open as well as close, and I see renal denervation like a huge airport hanger door which has just started to open. Good quality trials will determine how wide it opens.

The agreement calls for Medtronic to make an upfront cash payment of $800 million, plus commercial milestones equal to the annual revenue growth through the end of Medtronic’s fiscal year 2015. Medtronic had previously invested in Ardian and currently holds an 11% ownership stake in the Company. Based in Mountain View, California, Ardian develops catheter-based therapies to treat hypertension and related conditions.

“Hypertension is the leading attributable cause of death worldwide. It is a significant, escalating global healthcare problem affecting approximately 1.2 billion people and is associated with an increased risk of heart attack, stroke, heart failure, kidney disease and death,” said Sean Salmon, vice president and general manager of the Coronary and Peripheral Business at Medtronic. “We view renal denervation for the treatment of uncontrolled hypertension as one of the most exciting growth markets in medical devices. Ardian’s investigational catheter-based treatment for uncontrolled hypertension through renal nerve denervation complements Medtronic’s expertise in catheter design and ablation technologies, and augments Medtronic’s interventional therapies.”

Data from a clinical study of Ardian’s flagship product, the Symplicity Catheter System, were recently released at the American Heart Association 2010 Scientific Sessions in Chicago and published in The Lancet. It was reported that patients treated with the Ardian device experienced a 33 mmHg greater reduction in systolic blood pressure at six months (p<0.0001) than the control group. The Symplicity Catheter System has received CE mark and Australia TGA listing, but is not approved for sale in the USA.

“Ardian brings to Medtronic the Symplicity Catheter System and a growing body of evidence to support its clinical use for patients whose hypertension remains uncontrolled despite optimal medical management,” said Andrew Cleeland, president and CEO of Ardian. “Our integration into Medtronic creates a tremendous opportunity to leverage Medtronic’s global scale and scope to advance the treatment of uncontrolled hypertension.”

The transaction is expected to close in Medtronic’s third fiscal quarter of 2011, and is subject to customary closing conditions, including USA and foreign regulatory clearances.

Royal Philips Electronics, in partnership with Maquet are jointly showcasing the latest version of their hybrid operating room (OR) suite at Medica 2010. On display will be the Allura Xper FD OR Table which integrates the Philips Allura Xper angiographic X-ray system with the MAQUET Hybrid OR solution including hybrid table. Also shown are HeartNavigator, OR lights, monitors, and radiation protection walls. The hybrid OR suite is a simple, one–room solution combining facilities for both minimally invasive and open surgical procedures.

Globally, hospitals increasingly move towards more same day and minimally invasive surgery, such as catheter based cardiac treatments, which are often less costly and less strenuous for patients. Clinicians recognise the advantages of minimally invasive procedures for certain procedures and patients, which may include shorter patient recovery times, greater patient comfort and faster patient throughput.

Therefore hospitals today increasingly require their operating rooms to be flexible and adaptable to accommodate both minimally invasive as well as open surgical procedures, and to include the latest technologies. Since different interdisciplinary teams may need to operate in the same room over the course of a day, the key to success of a hybrid OR is its cross purpose functionality. All elements for both image guided and open surgical procedures must be well integrated and easy to access. 

The hybrid OR suite meets this growing need for multipurpose functionality and minimally invasive interventions to address a spectrum of cardiac conditions, both structural and degenerative. It provides a solution that combines the equipment needed to perform both open and endovascular cardiac procedures within the same room. 

The hybrid OR concept is a significant breakthrough in facilitating procedural collaboration between specialties, with hybrid OR procedures being coded by payors as a single procedure to encourage clinicians to make the best choice for the patient without the need for cost considerations. Surgeons and interventionalists believe that this concept will enable them to provide a wider range of treatments, improve care and reduce procedure costs.

Traditionally, X-ray imaging is used to navigate cardiac interventions performed in a cardiac catheterisation (cath) lab.  In recent times, 3D ultrasound imaging in visualising complex structures during interventions has become more important. The Philips/Maquet hybrid OR suite combines the sterility and instruments of a traditional operating room with the X-ray and ultrasound imaging systems plus the radiation shields of a cath lab.   

The Philips Allura Xper FD20 is a flexible X-ray system with a large 20-inch field of view for minimally invasive cardiac surgery; The Philips HeartNavigator combines CT pre-procedure images of a patient’s cardiac anatomy into a 3D  image and overlays it with live x-ray fluoroscopy information; The Maquet Magnus hybrid table system features a carbon fibre table top providing almost 360 degree radiotranslucency for optimum x-ray images, available in six versions with various lengths and travel paths. The Allura Xper and the Magnus are fully integrated, from the perspective of safety, optimal workflow and advanced functionality. The Hybrid OR Suite, as on display at Medica, enables clinicians to perform a full range of minimally invasive and open procedures.

The Philips/Maquet Hybrid OR Suite is customised for customer needs and designed using an advanced 3D architectural planning tool that provides a 3D visual of possible room configurations.  From high-quality, high-resolution, multi-modality advanced 3D room planning software (supporting confident decision-making), to surgical tables, lighting and other equipment considerations; the full scope of equipment combinations is assessed.

In the last five to seven years, there has been a bewildering array of new below-the-knee technologies. But the proof of benefit of these long balloons, drug-eluting stents and drug-coated balloons is still awaited. Yet, the evidence is beginning to emerge. Marc Bosiers, Dendermonde, Belgium told Interventional News that 12-month results of the prospective, randomised, multicentre, angio-controlled DESTINY trial comparing bare metal stents with drug-eluting stents show that the primary patency rates are 59% for balloon-expandable stents and 89% for drug-eluting stents, which is highly statistically significant (p<0.0001). This has led the investigators to conclude that this pivotal trial shows that there is an indication for primary stenting with drug-eluting stents in critical limb ischaemia patients with focal lesions. The DESTINY of drug-eluting stents clearly, is below-the-knee!

From the relatively well-established success in the aortoiliac or superficial femoral artery regions, a wave of treatment and innovation in endovascular therapies for critical limb ischaemia is geared towards below-the-knee vessels. Dedicated tools have improved the indications and the number of procedures. As occlusions are more prevalent than stenoses in the infrapopliteal arteries, there are now dedicated guidewires, dedicated long balloons and dedicated stents for the region. Experts point to the dedicated below-the-knee tools such as long low-pressure balloons and below-the-knee stents, either balloon-expandable stents, or self-expanding stents which have a role in making the difference in the treatment success or failure.

Angiologist Iris Baumgartner from Bern, Switzerland, says, “This is a field that has evolved so much over the last few years that I would call it revolutionary. When I started as an interventional trainee, below-the-knee was reserved for the high-profile interventionalists, as the material was so poor. There was indeed a high risk of failure, and the grave possibility of deteriorating the situation for the patient. Today, low profile wires and balloons have opened up a door for highly successful procedures.”

Gunnar Tepe, Rosenheim, Germany, agrees: “Technical success is certainly increasing with the use of better devices, especially wires and low profile crossing devices developed specifically for below-the-knee indications. There are currently several clinical trials underway, but at this point in time, there is no evidence as to what degree patients with critical limb ischaemia really benefit in terms of less restenosis. There is also clear data available that drug-eluting balloons and drug-eluting stents reduce restenosis.”   

Role of infrapopliteal stenting

The first glimmers of evidence are beginning to establish the promise of endovascular treatments of below-the-knee regions for patients with critical limb ischaemia. It is generally agreed that there is a large diversity in lesions below-the-knee and that the precise role of stenting remains to be determined. At the CIRSE 2010 conference in Valencia, Spain, FE Vermassen told delegates “There is no reason to withhold stenting if the angioplasty result is not sufficient. When stenting, use a dedicated below-the-knee stent.”

Stenting has been established by Siablis (JEVT 2007) with 29 patients and mean lesion length of 13mm, showing a primary patency rate of 40.5% at 12 months, Scheinert (Eurointervention 2006) with 30 patients and a maximum lesion length of 30mm obtained a primary patency rate of 67% at 10 months. Bosiers (Eurointervention 2008) also showed that with 50 patients with a mean lesion length of 21mm had a primary patency rate of 63% at 12 months.

For long infrapopliteal lesions, the choice of treatment is more complex. Bosiers emphasises that “We have to make a distinction between treatment strategies based on the lesion configuration.

a)    Long diffuse lesions (= majority of the patient population with critical limb ischaemia). For these patients, the optimal endovascular treatment consists of angioplasty with dedicated below-the-knee balloons and bailout stenting, using either self-expanding stents or balloon-expandable stents. Balloon-expandable stents are indicated for use in calcified lesions because they offer a high radial force, and in bifurcation lesions because they allow precise stent placement. Self-expanding stents are our preference in all other lesions.

b)    Short lesions below 4cm in length: Single centre results report primary patency rates of 40% after angioplasty-only, 40–60% after implantation of bare metal stents and 80–85% for drug-eluting stents. These results are confirmed by the DESTINY study. This is the first randomised study comparing the long-term results with DES and bare metal stents in patients with criticla limb ischaemia and short focal lesions below-the-knee,  with a maximum length of 40mm. Due to the good results at 12-months, we conclude that this pivotal trial shows there is an indication for primary stenting with drug-eluting stents in critical limb ischaemia patients with focal lesions.

The future of below the knee treatment

“The results of endovascular therapy for below-the-knee vessels will be further improved by the continuous technical evolution and new material developments. The two main innovations which will be interesting to follow in the future are drug-coated balloons and drug-eluting absorbable stents. There are many studies currently investigating the impact of treatment with drug-coated balloons in short and long lesions below-the-knee and, in follow-up the positive results from the coronary ABSORB trial with the polymer everolimus-eluting Bioresorbable Vascular Scaffold system. Abbott is planning an ABSORB BTK study, which will be conducted to evaluate the safety and efficacy of this bioresorbable vascular scaffold system in patients with severe claudication or critical limb ischaemia,” Bosiers said.

Speaking on further evolution, Tepe, who like Bosiers believes that drug-eluting bioabsorbable stents have the potential to be revolutionary, states that “In below the knee, better crossing devices either to stay in the lumen or re-entry devices would also be needed.”

Below the knee revascularisation: All or nothing

At the recent CIRSE 2010 conference, Jan H Peregrin, CIRSE president told delegates, “All accessible infrapopliteal lesions should be approached in patients with critical limb ishcaemia, no matter if they are TASC D type. By repeated percutaneous angioplasty, a secondary limb salvage  could be maintained as high as 73%, even 10 years after procedure.

The paper he presented was titled “Angioplasty of below-the-knee arteries: long term follow-up and factors influencing clinical outcome.” Peregrin said that a group of 1,268 patients/1,445 lower limbs with critical limb ischaemia who had had infrapopliteal angioplasty performed, was retrospectively analysed. The average age of patients was 67 +/-10.8 years, 70% of the patients were male. Main indications to angioplasty were: gangrene (50.2%), non-healing ulcer (17.0%) and rest pain (15.2%). Lesions were mostly of TASC C and D type, with average length 15.1cm. The average number of arteries intervened per limb was 1.77. The criterion of clinical success was salvage of limb salvage with maximally transmetatarsal amputation.

Peregrin’s team achieved 89% technical success in the arteries they intended to treat. Primary limb salvage at one year was 76.1%. Secondary limb salvage was 84.4%, 78.3% and 73.4% at one, five, and 10 years follow-up, respectively. The most significant negative clinical condition influencing limb salvage rate was presence of gangrene prior angioplasty, the most significant feature positively influencing limb salvage rate was the number of patent arteries after angioplasty (primary limb salvage: 0 arteries-56.5%, 1 artery-73.1%, 2 arteries-80.4% and 3 arteries-83.0%).       

This contrasted with the opinion of Vlad Alexandrescu, Department of Vascular Surgery, Princess Paola Hospital, Belgium who advocates revascularisation of a target vessel.

Although it remains hard to compare angioplasty with surgery, there is common agreement that an endovascular approach should even be the first choice treatment. Baumgartner says, “Due to the low complication rates and no need for bypass veins a wider spectrum of elderly, fragile patients can be treated, who really need treatment. I think we will see decreasing amputation rates in the coming years. But I also have to raise my finger at this point and say– it is like modern art, not everyone can do it! A fundamental caveat is that these techniques should be envisioned only in the hands of experienced operators who are capable of fast and proficient management of potential complications.

Bosiers agrees, “The primary approach in patients with critical limb ischaemia is minimally invasive endovascular treatment because many critical limb ischemia patients have diabetes, present with prohibitive comorbidities, or are poor candidates for surgery because of inadequate conduit or lack of suitable distal targets for revascularisation. This is confirmed by the current TASC II 2007 recommendations. Furthermore, endovascular therapy offers the advantages of local anaesthesia, the possibility of intra-arterial medication administrating, potentially reduced costs (even in anticipation of the need for re-intervention in many patients), and shorter hospital stays.

He sums it up with: “The final goal is, by early detection and adequate treatment, to reduce the amputation rate and increase the quality of life in patients with critical limb ischaemia.”

Roger Greenhlagh in London, UK, gives a vascular surgical perspective. There has indeed been an upsurge in below the knee interventions and this is an exciting area. The vascular surgeon has learned that proximal revascularisation should always take precedence over distal. Thus, aorto-iliac has precedence over femoral and profunda interventions which have precedence over popliteals which come ahead of below the knee intervention. These more proximal vessels are likely to produce a greater perfusion to the foot than more distal ones.

The endovascular below the knee technologies need to be judged on their own merit therefore, and not is association with proximal procedures if we want to learn about the tibial interventions in their own stand alone state.

The other burning issue is to go further than seeing a short-term anatomical correction from below the knee intervention and to seek long-term data on the ability of these technologies to save legs. The starting point thus has to be on a population of patients with critical limb ischaemia (ref 1981, BJS) and without proximal intervention followed for some years, five in the first instance. If these data appear and are convincing, many more patients will be referred for below the knee intervention, and open distal bypass with the attendant slow healing of often infected wounds will become virtually extinct.

Primary stenting in iliac occlusion reduces rate of major periprocedural complications. Results of the STAG trial, a multicentre randomised clinical trial comparing angioplasty with stenting for the treatment of iliac occlusion were presented by Naomi Hersey, Sheffield Vascular Institute, Northern General Hospital, Sheffield, UK at the 2010 CIRSE congress in Valencia, Spain.

Hershey told delegates that both percutaneous transluminal angioplasty and primary stenting are key treatment options for iliac occlusions. The 1998 Dutch Iiliac stent trial, which was published in The Lancet, compared the primary stent to angioplasty with selective stent and found that while there was no significant difference in technical or clinical outcome, long-term follow-up showed that angioplasty with a selective stent was significantly different symptomatically. There was no published data comparing primary stent to angioplasty in iliac occlusion, she said. “In the six–centre prospective study, inclusion criteria were defined as more than three months of claudication, presence of an iliac occlusion of less than eight centimetres and at least a single vessel run-off”.

118 patients with iliac occlusion and symptoms of chronic leg ischaemia were randomised to either angioplasty (n=61) or angioplasty and stent insertion (n=57). If percutaneous transluminal angioplasty resulted in any antegrade flow, then a stent was not placed irrespective of the residual gradient. Periprocedural and 30 day complications were recorded. Long-term patency was assessed clinically using the Rutherford scale and angiographically by digital subtraction angiography at one and two years.

Four patients were excluded from the analysis due to protocol violations. There were increased complications within the angioplasty group versus the stent group (24 vs. 5.3%, p=0.004). There were increased complications within the angioplasty group (15 vs. 4%). There were no differences in clinical outcomes at two years. Immediately post procedure there was a significantly higher residual gradient within the angioplasty group group versus stent group (p=0.0001); at two years there was no significant difference in gradient (p=0.2).

Endovascular placement of stents has been proposed as a more effective treatment than angioplasty, a safe and simple treatment excluding additional costs associated with the use of stents.
The STAG trial is the only randomised controlled trial comparing angioplasty and stenting for the treatment of iliac occlusion. There was significantly increased primary failure rate for angioplasty versus stenting and also an increased rate of complication. At two years, the clinical and haemodynamic assessment were not significantly different.

Johannes Lammer, Vienna, Austria, presented preliminary data from the VIASTAR study at CIRSE 2010. In the trial, the Viabahn Endoprosthesis (Gore) is compared to bare metal stents in TASC C and D lesions.

“Bare stent technology has been tested in short superficial femoral artery lesions (TASC A and B) has been shown to be superior to percutaneous angioplasty in two randomised controlled trials. The old Viabahn endoprosthesis has shown promising patency rates in long superficial femoral artery lesions, but the vibrant study failed to demonstrate superiority over bare stents at one and two year follow-up. But, the new Viabahn with heparin-bonding technology and contoured edge has shown less target lesion revascularisation and restenoses so far,” Lammer said. The Viastar study is a prospective, randomised, multicentre European study, conducted independently of the company. Its objective is to evaluate the performance of Viabahn Endoprosthesis with propaten bioactive surface (5–8 mm devices) and compare their efficacy to bare nitinol stents in treating long lesion superficial femoral arterydisease (lesions 10 –27 cm).

The primary efficacy endpoint for the study is primary patency measured at one year post-procedure by colour Doppler ultrasound and CT angiography or digital subtraction angiography. The primary safety endpoint is a composite of serious procedural (30-day) adverse events, including death, myocardial infarction, study limb amputation, and access site and treatment site complications requiring surgery or blood transfusion.

Secondary endpoints include technical and clinical success, primary and secondary patency at one and two years and target lesion revascularisation and target lesion revascularisation at one and two years

Lammer told delegates that 98 patients with a mean age 67.9 years (45–85), 69 of whom were male were enrolled in the study. The mean lesion length 21.6 cm (10–32), and mean lesion diameter was 5.4mm. 51 patients got Viabahn and 47 were treated with the nitinol stent.

At six months follow-up, there were 40 patients and at 12 months data from 12 patients. Data from these contributed to the preliminary results.

Lammer told delegates that with the Viabahn Endoprosthesis, there were two instances of target lesion revascularisation. These were due to active thromboses due to discontinuation of Plavix, and one asymptomatic stenosis which was greater than 50%. On the other hand, with the nitinol stent, there was one occlusion, four cases of target lesion revascularisation due to in-stent restenosis and one case of asymptomatic in-stent restenosis (greater than 50%).

“Contour SE poly vinyl alcohol microspheres give adequate uterine fibroid infarction when the appropriate endpoint is used,” Shlansky-Goldberg, associate professor of Radiology, Philadelphia, US told delegates.

Importantly, the results of this study seem to “go against the grain” when compared to previous studies by Spies et al (randomised, 2005) and Gary Siskin et al (randomised, 2008) and Abramowitz et al (non-randomised, 2009) all of which have found Contour SE to be inferior to Embospheres. There are, however, differences in the studies regarding the size of the Contour SE particles, mean uterine volumes of patients and endpoints, said Shlansky-Goldberg.

The session was titled “Controversies: A controlled, randomised study comparing Contour SE microspheres to Embosphere microspheres in uterine artery embolization.”

Shlansky-Goldberg and investigators set out to look at both dominant and non-dominant fibroids to try and tease out how Contour SE microspheres (Boston Scientific) which are spherical polyvinyl alcohol microspheres and Embosphere microspheres which are tris-acryl gelatin microspheres (Biosphere Medical) work. The primary endpoint of the study was leiomyoma devascularisation measured by contrast enhanced MRI at 24 hours post uterine artery embolization.

Secondary endpoints were fibroid specific quality of life measures at three months, maximum level of nausea and pain measured using the visual analogue scale at 24 hours, fluoroscopy and procedure time and adverse events in hospital post-procedure.

They found that dominant and non-dominant fibroid infarction at 24 hours is equivalent between 700-900 micron Contour SE and Embosphere when a five cardiac beat endpoint with no forward progression rule is used. They also found that quality of life, fibroid infarction and the other secondary endpoints are similar between these two agents at three months.

Investigators enrolled 62 patients, two of which withdrew from the study. They then randomly allocated 30 patients to the group receiving uterine artery embolization with Contour SE particles, (group A) and 30 patients to those receiving uterine artery embolization with Embospheres (group B). Shlansky-Goldberg explained that “At the end, at 24-hrs follow-up, we had 29 patients in group A, and 30 people in group B. Then, at three months follow-up we had 28 people in group A (93.3%) and 28 patients in group B (96.7%). Both groups were similar, dominant fibroid volumes were similar, fibroid locations are also similar.”

Shlansky-Goldberg told delegates that in terms of total fluoroscopy time (group A=31+/- 19 minutes, group B 25+/-8.7 minutes), total procedure time (group A=102+/- 50 minutes, group B 96+/-39.6 mins) number of syringes/vials used, and length of hospital stay, the two groups did not have statistically significant outcomes.

Results:

“At 24 hours, with regard to the dominant fibroids, 29 out of 29 were completely infarcted in the Contour SE group. Similarly, 28/30 was infarcted in the Embosphere group. This resulted in a difference of 6.7%,” Shlansky-Goldberg said.

“In summary, we have demonstrated non-inferiority, because there was significant non-inferiority with a p value of 0.001. Statistically, you cannot say that the two behaved the same, but you can say that Contour SE was non-inferior with a high p value,” he said. “There were no significant differences in terms of outcomes of infarction rate of the dominant fibroid at three months, and no significant differences in terms of the secondary endpoints. At 24 hours, the non-dominant fibroids were either 100% infarcted or not infarcted at all. This held true for those less than 2cm in diameter and also for the larger ones. This result also held true at three months larger leiyomas were either 100% infarcted or not infarcted at all,” he pointed out.

When comparing the results of this study with previous data, Shlansky-Goldberg, clarified that James B Spies et al’s 2005 study used 500-700 micron spherical poly vinyl alcohol and showed that it was inferior. “The difference in this study was that, we upsized, we used 700-900 micron,” he said. He also compared it with Gary Siskin et al’s 2008 study which compared 700-900 micron spherical poly vinyl alcohol to show that it was inferior. “In this study, our endpoint was almost complete stasis for five beats. Some might say that this is overembolising. This was a point of difference, and also in Siskin’s population, the uteri were about a third smaller in volume. I am not sure how these issues might have affected outcomes,” he said.

“Spherical poly vinyl alcohol gave adequate uterine fibroid infarction when the appropriate size and endpoint was used in this prospective randomised trial,” concluded Shlansky-Goldberg.

James B Spies, who was present in the audience, said it was an excellent study. He commented that the endpoint in the previous studies were probably not as aggressive as in this one and asked Shlansky-Goldberg if he had difficulty in reaching this endpoint. To this, the latter replied, “Generally speaking, no.” Then Spies asked if the results meant that Shlanksky-Goldberg would be sticking with old style poly vinyl alcohol for uterine artery embolization. To this, the latter replied, “It is always a tough choice. By sticking to a very aggressive endpoint, we do not have the issues that we had before.”  Spies clarified that this was a small study that suggests Contour SE is not inferior, a larger study is likely needed to see if that is really the case.

Boston Scientific’s spherical embolisation agent is able to provide adequate uterine fibroid infarction. Richard Shlansky Goldberg presented the data at a satellite symposium organised by the company at CIRSE 2010, October, Valencia, Spain.

“Contour SE PVA microspheres give adequate uterine fibroid infarction when the appropriate endpoint is used,” Shlansky-Goldberg, associate professor of Radiology, told delegates.

Importantly, the results of this study seem to “go against the grain” when compared to previous studies by Spies et al (randomised, 2005) and Gary Siskin (randomised, 2008) and Abramowitz et al (non-randomised, 2009) all of which have found Contour SE to be inferior to Embospheres. There are, however, differences in the studies regarding the size of the Contour SE particles, mean uterine volumes of patients and embolisation endpoints, said Shlansky Goldberg.

The session was titled Controversies in UAE: A controlled, randomised study comparing Contour SE microspheres to Embosphere microspheres for uterine artery embolisation.

Shlansky-Goldberg and investigators set out to look at both dominant and non-dominant fibroids to try and tease out how Contour SE microspheres (Boston Scientific) which are spherical polyvinyl alcohol microspheres and Embosphere microspheres which are tris-acryl gelatin microspheres (Biosphere Medical) work. The primary endpoint of the study was leiomyoma devascularisation measured by contrast enhanced MRI at 24 hours post UAE.

Secondary endpoints were fibroid specific quality of life measures at three months, maximum level of nausea and pain measured using the visual analogue scale at 24 hours, fluoroscopy and procedure time and adverse events in hospital post-procedure.

They found that dominant and non-dominant fibroid infarction at 24 hours is equivalent between 700-900 micron Contour SE and Embosphere, when a five cardiac beat endpoint with no forward progression past the horizontal segment of the uterine artery rule is used for Contour SE. The “pruned three” end point was used for Embosphere. They also found that quality of life, fibroid infarction and the other secondary endpoints are similar between these two agents at three months.

Investigators enrolled 62 patients, two of which withdrew from the study. They then randomly allocated 30 patients to the group who were receiving uterine artery embolisation with Contour SE particles (group A) and 30 patients to those receiving UAE with Embospheres (group B). Shlansky-Goldberg explained that “At the end, at 24 hrs follow-up, we had 29 patients in group A, and 30 people in group B. Then, at three months follow-up we had 28 people in group A (93.3%) and 28 patients in group B (96.7%). Both groups were similar, dominant fibroid volumes were similar, fibroid locations are also similar.”

Shlansky-Goldberg told delegates that in terms of total fluoroscopy time (group A=31+/- 19 minutes, group B 25+/-8.7 minutes), total procedure time (group A=102+/- 50 minutes, group B 96+/-39.6 mins) number of syringes/vials used, and length of hospital stay, the two groups did not present statistically significant differences.

Results

“At 24 hours, with regard to the dominant fibroids, 29 out of 29 were completely infarcted in the Contour SE group. Similarly, 28/30 were infarcted in the Embosphere group. This resulted in a difference of 6.7%,” Shlansky-Goldberg said.

“In summary, we have demonstrated non-inferiority, because there was significant non-inferiority with a p value of 0.001. Statistically, you cannot say that the two behaved the same, but you can say that Contour SE was non-inferior with a high p value,” he said.

“There were no significant differences in terms of outcomes of infarction rate of the dominant fibroid at three months, and no significant differences in terms of the secondary endpoints. At 24 hours, the non-dominant fibroids were either 100% infarcted or not infarcted at all. This held true for those less than 2 cm in diameter and also for the larger ones. This result also held true at three months larger leiyomas were either 100% infarcted or not infarcted at all,” he pointed out.

When comparing the results of this study with previous data, Shlansky-Goldberg, clarified that James B Spies et al’s 2005 study used 500-700 micron spherical PVA and showed that it was inferior. “The difference in this study was that, we upsized, we used 700-900 micron,” he said. He also compared it with Gary Siskin et al’s 2008 study which compared 700-900 micron spherical PVA to show that it was inferior. “In this study, our endpoint was almost complete stasis for five beats. Some might say that this is overembolising. This was a point of difference, and also in Siskin’s population, the uteri were about a third smaller in volume. I am not sure how these issues might have affected outcomes,” he said.

“Spherical PVA gave adequate uterine fibroid infarction when the appropriate size and endpoint was used in this prospective randomised trial,” concluded Shlansky-Goldberg.

James B Spies, who was present in the audience, said it was an excellent study. He commented that the endpoint in the previous studies were probably not as aggressive as in this one and asked Shlansky-Goldberg if he had difficulty in reaching this endpoint. To this, he replied,“Generally speaking, no.” Then Spies asked if the results meant that Shlanksky-Goldberg would be sticking with old style PVA for UAE. To this, the latter replied,“It is always a tough choice. By sticking to a very aggressive endpoint, we do not have the issues that we had before.”

Boston Scientific Corporation has announced the global launch of its Journey Guidewire, an innovative 0.014” guidewire designed for use in challenging, small vessel peripheral angioplasty procedures. The Journey Guidewire strengthens Boston Scientific’s broad portfolio of devices designed to address physician needs in treating arteries below the knee.

James Benenati, medical director of the Baptist Cardiac and Vascular Institute in Miami, and president of the Society of Interventional Radiology, has performed some of the initial procedures using the new Journey Guidewire, including a live case at the recent Transcatheter Cardiovascular Therapeutics scientific symposium.

“In my experience, the Journey Guidewire provides exceptional torque and flexibility, particularly in difficult cases involving small vessels or tortuous anatomy,” said Benenati. “This highly durable guidewire offers outstanding precision and tracking to help access the toughest peripheral lesions.”

The Journey Guidewire builds on Boston Scientific’s advanced guidewire technology used in coronary and neurovascular interventions. It features a micro-cut nitinol sleeve designed to provide efficient transmission of torque energy for more precise turn-by-turn response and control compared to conventional spring-coil guidewires. The nitinol distal core and hydrophilic coating are designed to enhance wire durability, tactile response and device delivery for improved overall performance.

“The Journey Guidewire reflects Boston Scientific’s commitment to providing physicians the most advanced solutions for peripheral interventions,” said Joe Fitzgerald, senior vice president and president of Boston Scientific’s Endovascular Unit. “Journey enhances our below-the-knee portfolio, which includes a number of leading products to treat this challenging anatomy.”

InSightec announced that it will be launching ExAblate One for the treatment of uterine fibroids, adenomyosis and research options in women’s health and the ExAblate OR system as the operating room of the future at the upcoming Cardiovascular and interventional radiological society of Europe (CIRSE) 2010 meeting.

The ExAblate family of systems employs focused ultrasound to non-invasively heat and destroy targeted tissue under MR guidance. The MRI system, identifies and targets tumours, while providing real time temperature monitoring of the treated tissue.

With experience in treating over 6000 patients at more than 80 centres around the world, the ExAblate family of systems offers a proven and mature platform for commercially approved treatments as well as research options for a wide range of clinical indications.

Innovative ExAblate One expands treatment choices for women suffering from uterine fibroids and adenomyosis. Recent advances in ExAblate technology now enable the treatment of large and vascular fibroids as well as adenomyosis, broadening the patient base. The ability to treat greater fibroid volumes is expected to result in greater clinical efficacy. ExAblate significantly improves adenomyosis symptoms, and in many cases can improve a patient’s chances of overcoming infertility caused by the condition.

Patients treated for uterine fibroids or adenomyosis typically return to their normal routine within twenty four hours of the procedure, a major improvement over most fibroid treatment techniques. A growing number of women have become pregnant following the ExAblate treatment. Studies have shown that MR guided focused ultrasound (MRgFUS) may even improve fertility in women suffering from infertility caused by uterine fibroids.

Experience at sites around the world has shown that ExAblate significantly increases patient interest in MRgFUS treatment and facility traffic. A leading site in Tokyo, Japan reported that the number of patients treated for uterine fibroids increased by 550% in one year.

The ExAblate treatment has also been proven as a cost-effective alternative to current treatments, meeting acceptable criteria for optimal cost-effectiveness in fibroid treatment.

“MR guided focused ultrasound use in the treatment of uterine fibroids has been an accepted and viable option for increasing numbers of women for several years now. However, with the enhancements offered by ExAblate One we are able to offer even more women the option of treatment with an effective, dedicated women’s health platform with predictable results.” Said prof. Wladyslaw M Gedroyc. “In addition to the benefits to patients, such as preservation of the uterus and improved chances of fertility, we have also seen a significant reduction in treatment time.”

The ExAblate OR platform is a non-invasive image guided and controlled acoustic operating room. The system incorporates interchangeable cradles for each application that are interfaced with a single common table. ExAblate OR offers both commercially approved and research treatment options for a multitude of clinical indications such as: uterine fibroids and adenomyosis, breast cancer, prostate cancer, pain palliation of bone metastases and various other indications.

ExAblate One and ExAblate OR are compatible with both GE Healthcare’s Signa and Discovery MRI product lines and have a newly designed patient bed with ergonomic advantage for patients, streamlined user interface and improved usability for physicians.

Terumo announced the first US patient implant in the occlusive/stenotic peripheral artery revascularisation study (OSPREY), which will evaluate the safety and efficacy of its MISAGO peripheral self-expanding stent system for use in the superficial femoral artery (SFA).  

A unique feature of the OSPREY clinical trial is that it will simultaneously enrol patients in the US and Japan. Referred to as “Medical device collaborative consultation and review of premarketing applications” under the larger harmonisation by doing HBD initiative. The OSPREY trial was selected as one of two projects to pilot this approach, which is intended to shorten the gap between product approvals in these two significant world healthcare markets.

In the US, OSPREY is a single-arm, multi-centre, non-randomised prospective clinical trial for the treatment of atherosclerotic stenoses and occlusions of the SFA. In Japan, there are two arms of the study, 50 patients receiving the MISAGO stent system and 50 patients receiving percutaneous transluminal angioplasty.

The primary endpoints of the US study are, primary stent patency rate at one year as confirmed by duplex ultrasound or angiography and freedom from major adverse events within 30 days of the procedure, which would result in target lesion revascularisation, amputation of the treated limb or death.

The study will include up to 350 patients, a maximum of 250 patients in up to 30 centres in the US and 100 patients in Japan. Japan received regulatory approval to begin the trial last year and has already started to enrol patients.

The MISAGO peripheral self-expanding stent system consists of a nitinol stent pre-mounted on the distal portion of a rapid-exchange delivery catheter system. The stent has three radiopaque markers located on each end of the stent to help ensure accurate placement in the lesion. The unique design distributes the dynamic superficial femoral artery stress loads throughout the stent’s struts providing not only flexibility, but also durability against bending, compression, and torsion. The MISAGO stent system features the first rapid-exchange delivery catheter for use in the SFA.

AtheroMed announced the start of enrollment in the EASE study to evaluate the safety and effectiveness of the Phoenix Atherectomy catheter, a minimally invasive device for the treatment of peripheral arterial disease (PAD) in the legs.  EASE – Endovascular Atherectomy Safety and Effectiveness, is an FDA-approved Investigational Device Exemption (IDE) clinical trial that will enroll 90 patients at up to 20 clinical sites.

The first patient was treated by Craig Walker, an interventional cardiologist and Medical Director of the Cardiovascular Institute of the South in Houma, Louisiana. “The Phoenix Atherectomy device created a large, smooth channel in a totally occluded anterior tibial artery with no evidence of distal debris. The device was easy to prep and quite easy to use. I am optimistic that this will be a useful tool in the treatment of atherosclerotic disease” commented Dr. Walker.

The Phoenix Atherectomy catheter is designed to cut, capture and convey arterial plaque into an external bag visible to the physician. The catheter is front-cutting and has a unique deflectable tip engineered to treat a range of blood vessel sizes with a single insertion of one, single-use device. “The Phoenix Atherectomy catheter has been developed to provide physicians with a safe, versatile, easy to use alternative for treating PAD in the legs” said Will McGuire, president and CEO of AtheroMed.

The internet, so fundamental to our lives, is teeming with videos. There are videos of common and not-so-common IR procedures, explanations and justification for controversial studies and trials, and also videos of physicians advocating for the subspecialty itself. There are videos for patients, for fellow IRs and also educational videos for younger IRs. Interventional News spoke to some key IRs and found out why these internet videos are so important, and why it is vital that they are monitored.

Internet videos showing IR procedures are available, literally at your fingertips. Key audiences (IR physicians seeking information about new or difficult procedures, non-IR physicians who want to understand what IR has to offer, medical students, patients who are looking for alternatives to traditional therapy or information about procedures that they will undergo, hospital administrators who need to learn what IR does, insurers, government regulators, and politicians) will at some point, turn to the internet for help. And there is a lot to find — right from short clips from the ‘Father of interventional radiology’, Charles  C Dotter’s 1965 film “Transluminal angioplasty”, in which he introduces the concept of angioplasty, to videos where interventionalists appear to describe a procedure, only to actually promote new and untested products.

A picture is a thousand words and a video is a thousand pictures

John Kaufman, associate director, Dotter Interventional Institute and chief, Vascular and Interventional Radiology, Oregon Health & Science University Hospital told Interventional News what would draw him to watching videos made by his colleagues. “We are all craftspeople, and each of us develops a specific and different way of accomplishing the same goal. I can always learn from my colleagues. Besides, it is one thing to hear someone describe how they do something; it is another thing entirely to see it for yourself,” he said.

Konstantinos Katsanos adds, “Digitisation of radiological images and procedural videos has produced a wealth of teaching files storming the internet. Online resources include digital image files, lecture web-casts, online conferences or just interesting everyday cases. The vast majority of this educational material is usually available free of charge to your laptop or mobile smart-phone and is poised to play a major role in continued lifelong training of physicians ranging from student to resident and attending or consultant level.”

Katsanos believes that video recordings of interventional radiology procedures are set to play a major role in the dissemination of knowledge among involved practitioners and interested patients. “A picture is a thousand words and a video is a thousand pictures. Internet videos of novel, interesting, complicated or just routine IR cases are unique in demonstrating the key elements, tips and tricks of interventional techniques, which remain the essence of the IR discipline. Looking at colleagues’ video cases is not just fun, but extremely educational,” he maintains.

Dimitrios K Filippiadis, consultant interventional radiologist,  Evgenidion University Hospital, Athens, Greece agrees: He says “It is vital to remember that interventional radiology is a technique-oriented field. Even though there are guidelines pertaining to technique, each interventionalist when he carries out a procedure adds his own personal touch. I am certain that by means of internet videos on how a procedure is performed, interventional radiology can assist the growing number of interventionalists globally to expand and improve their standards.”

Filippiadis also points out that by closely watching a video where an IR procedure is performed, one can appreciate not only details on the technique itself and the imaging modality used, but also how interventionalists in different countries act inside their own suites and how they work and collaborate with their own teams.”

Unregulated patient videos, a cause for concern

While interventionalists almost unanimously accept that the internet is a fantastic medium via which to take their message to their patients, many are expressing concern about the rather unregulated nature of the videos.

Kaufman says, “Well-done videos that are designed for patients can be enormously important for this specialty. However, it would be best to provide these videos in a regulated manner so that patients can be comfortable about the quality and reliability of the information in the video.

“The quality of the content on the internet is essential but very hard to ensure. Anyone can post anything. Physicians posting videos of their procedures should adhere to the same ethical standards as any other scientific publication. The goal is to promote IR procedures from which patients will benefit, not to promote IR or IRs,” he says.

Filiappiadis concurs. “Patients who have already decided on an IR procedure as their therapy mode, could watch a video and this may reduce his/her fear of the unknown. But I must emphasise on the quality of the information provided. From a patient’s point of view, less-than ideal quality level of the provided information is simply not acceptable. So patients and others should be urged to visit specific patient and public websites of the major interventional societies like CIRSE or SIR for reliable content.”

The respondents also pointed out that while e-learning could help young interventionalists to gain exposure to basic or advanced procedural techniques before actual practice, and appreciate the involved risks and treatment of potential complications, it misses the invaluable person-to-person mentoring, the value of which cannot be overstressed. “Therefore, use of online resources should always be considered in the context of real-life training and hard work,” they said.

The US FDA has recommended that implanting physicians and clinicians responsible for the ongoing care of patients with retrievable IVC filters should consider removing the filter as soon as protection from pulmonary embolism is no longer needed. To reduce the risks to patients, the FDA has urged physicians who implant these filters to regularly consider the risk/benefit profile for each individual patient and to give strong consideration to removing these devices from patients who may no longer be at increased risk of pulmonary embolism

Previously, in most places the standard of care regarding IVC filters was to consider placement to be irrevocable unless otherwise indicated.
The warning has been issued on the basis that since 2005, the FDA has received 921 device adverse event reports involving IVC filters, of which 328 involved device migration, 146 involved embolizations 70 involved perforation of the IVC, and 56 involved filter fracture. Some of these events led to adverse clinical outcomes in patients.

SIR response to FDA advisory

The Society of Interventional Radiology has issued a release stating that according to the FDA, use of IVC filters has grown over the years, from 167,000 in 2007 with projections to 259,000 in 2012. “The majority of filters placed are intended to be left in place forever and are not intended to be removed. It should also be noted that even the filters that have the option to be removed may be left in place permanently and the filters on the market have FDA approval for permanent placement,” it says.

“It is worth noting that the SIR’s recommendations closely parallel the current FDA recommendations.

Specifically, the SIR recommends that patients with optional or retrievable IVC filters should be periodically re-assessed as to the appropriateness of leaving the filter in place, and that it is reasonable to consider both the individual patient’s risk of suffering a fatal pulmonary embolism and the risk of late

device complications in making this decision. In patients in whom resumption of blood-thinning drugs is judged likely to be safe and effective in preventing pulmonary embolism, it may be appropriate to remove the filter. It should be noted that there have been no recalls on the filters. The FDA says that it will issue a final statement after completing an analysis on filter problems.”

Michael Lee, Professor Michael Lee, professor, Department of Radiology, Beaumont Hospital, Dublin, Ireland, told Interventional News that  the placement of optional/retrievable IVC filters has exploded over the last ten years.  “Unfortunately, the increased use of these devices has not been matched by level one studies confirming their efficacy.  In particular, the prophylactic indications for optional/retrievable have little supportive data. The FDA is concerned that  IVC filters placed on an intent to retrieve basis are not always retrieved.  The FDA recommends that implanting physicians together with referring clinicians remove the retrievable filter as soon as protection from PE is no longer needed.”

Lee emphasised that the FDA statement is important for two reasons;  It confirms what many IRs have known for some time that there is no perfect  retrievable filter, with many prone to complications and that not all adverse events are reported so there are likely many more of these adverse events. 

“What should we as IRs do?,” he asked. “ I would propose the following; firstly, to fulfil our duty of care we need to consent our patients appropriately (informing patients that the filters are temporary, and will be removed after the risk of PE subsides, and we need to also indicate that it may not be  possible to remove some filters depending on factors such as filter tilt, dwell time etc. Secondly, we as IRs need to take primary responsibility for device removal (this means organising a date for removal in conjunction with the referring physician, at the time of filter placement; patients with retrievable filters should also be seen in IR OPD). Thirdly, as an IR community we need to urgently obtain evidence with regard to retrievable/optional filter placements, for prophylactic indications, in particular. With the latter in mind CIRSE is embarking upon a retrievable/optional filter registry, which will hopefully answer question with regard to current indications for prophylactic placement, dwell times of retrievable/optional filters, adverse events and complications during retrieval,” he added.

William T Kuo, assistant professor, Vascular and Interventional Radiology, Stanford University Medical Center, USA has a similar perspective:  “The FDA’s announcement confirms my suspicion that problems from prolonged filter implantation have generally been underrecognised. In retrospect, I have observed an increase in such filter complications referred to us for treatment over the last several years. These patients have inspired us to develop alternative retrieval methods for embedded filters in order to reduce morbidity, alleviate anxiety, and reduce further risks from prolonged filter implantation. Although many filter issues have resulted from poor follow-up, I have also seen filter-related problems arise in patients with close monitoring. At the very least, I believe the interventionalist who inserted the filter must be accountable. For those of us who have established IVC filter clinics, the FDA’s recommendation reaffirms our commitment to these crucial efforts.”

Two specific types of vena cava filters, devices used to prevent blood clots from reaching the lungs, appear to have evidence of fracturing inside the body, with some fractured fragments travelling to the heart and causing potentially life-threatening complications, according to a report posted on the JAMA website Archives of Internal Medicine.

One of the filters, the Bard Recovery filter, was developed as a device meant to be able to function inside a patient’s body on a permanent basis. Made commercially available between April 2003 and October 2005, the device consisted of two levels of six radially distributed “arms” and “legs” that anchor the filter to the vein and trap any clots. However, these arms and legs reportedly have broken off in some patients. In September 2005, Bard modified the design of the filter to improve its resistance to fracture. The modified Bard G2 cava filter has been implanted in more than 65,000 patients since, according to the article.

Following one initial case of a fractured filter, William Nicholson, of York Hospital, York, Pennsylvania  and colleagues evaluated all 189 patients who received either a Bard Recovery or a Bard G2 vena cava filter at that institution between April 2004 and January 2009. Of these, 35 had died and 10 had already had their filter removed.

80 patients underwent fluoroscopy to assess the integrity of the filter, and those whose filter was fragmented also underwent echocardiography and cardiac computed tomography. Of those examined, 13 had at least one arm or strut fracture from their filter; ultimately, three of those patients experienced life-threatening symptoms of rapid heartbeat or fluid build-up around the heart and one experienced sudden death at home.

“These data initially suggest that the fracture rate for the Bard G2 filter is approximately half that of the Bard Recovery filter. However, on further analysis, this conclusion may not be accurate,” the authors wrote. The average time since filter implantation was approximately four years for Bard Recovery filter patients and two years for Bard G2 filter patients. The report goes on to conclude that “the propensity for filter fragmentation may be directly related to the duration of implantation. Patients and their physicians should be educated about this fact so that they have the opportunity to consider having the filter removed.”

According to the article, venous thromboembolism – the formation of blood clots in the veins – occurs in more than 200,000 Americans every year. Anti-clotting medications are the standard therapy for patients with this condition. However, some patients cannot take these drugs and others may continue to develop clots despite taking medications. Devices placed in the vena cava (the large vein returning blood to the heart from the lower body) are designed to replace the job of the drugs as an alternate therapy in these patients.

Medtronic has announced the completion of enrolment in a clinical trial of the company’s Complete SE (self-expanding) vascular stent for the treatment of atherosclerosis in the superficial femoral artery (SFA), including the proximal popliteal artery (PPA), which runs under the skin of the thigh.

Approved by the FDA under an investigational device exemption (IDE), the Complete SE SFA study is a prospective, multicentre, single-arm trial to evaluate the safety and efficacy of the Complete SE vascular stent system in the treatment of de novo and/or restenotic lesions or occlusions in both arteries.

The study enrolled 196 patients with symptomatic, ischemic peripheral arterial disease (PAD), with the two primary endpoints being major adverse events and patency of the stent at 12 months.

PAD of the lower extremities, including the SFA, affects approximately 8 million people in the United States each year, despite many patients being unaware of their condition or its consequences. PAD patients have a two to six-fold increase in cardiovascular mortality and develop a significantly increased risk of amputation, disability and diminished quality of life.

“Many people are unable to recognise the symptoms of PAD, and the condition is often undiagnosed by healthcare professionals,” said Dr John Laird, medical director of the Vascular Centre at the University of California, who served as the study’s US principal investigator. “With this trial, Medtronic is partnering with physicians around the world to expand clinical knowledge about a potentially serious health condition while at the same time generating data in support of the safety and efficacy of its Complete SE stent in the treatment of PAD.”

Microsulis Medical Ltd (MML) successfully launched the Acculis percutaneous microwave tissue ablation system, Accu2i pMTA, at the second European Conference on Interventional Oncology (ECIO) in Florence, Italy. A revolutionary new device for destroying tumours, the system is a 1.8mm diameter closed water-cooled needle that brings the benefits of microwave ablation into the realm of interventional radiology, with applications in liver, lung, bone, kidney and appropriate other sites where local tumour control can be safely secured using volume ablation.

This year’s ECIO attracted over 800 specialist interventional radiologists, surgeons and interventionalists from around the world, as well as providing a major industry technology showcase for leading device manufacturers and distributors.

“The conference has been an extremely successful launch for us” commented Stuart McIntyre, CEO of Microsulis. “This is especially pleasing to us, as it is the latest in a series of product innovations, based on the unique Acculis MTA technology – all developed and patented in the UK.”

The Accu2i pMTA is the most powerful tumour ablation system currently available, combining extreme ease of use with the widest range of clinical applications. The device is a single high power high frequency 2.45GHz microwave needle that can address tumours over five centimetres in size in just six minutes, and is therefore between three to ten times faster than other systems. Its launch follows two years of extensive clinical use and evaluation around the world in major liver centres in the US, Asia-Pacific, UK and Europe. It was CE-marked in February 2010 and further international regulatory clearances are expected shortly.

“This system enables surgeons to extend treatment to liver cancer patients who would not normally have been treated. Ongoing studies suggest significantly improved clinical outcomes for tumour control, adding to our armamentarium” said Mr David Lloyd, Consultant HPB Surgeon from Leicester Royal Infirmary, who invented the system along with Professor Nigel Cronin and his microwave science team from the University of Bath, England.

W L Gore & Associates (Gore) has received European CE mark approval for the 25cm Gore Viabahn Endoprosthesis with Propaten bioactive surface. The new 25cm Gore Viabahn Endoprosthesis is the longest length stent-graft available, designed to cover more of the lesion in the superficial femoral artery (SFA), potentially reducing the need for multiple devices.

The recently redesigned Gore device features a precision laser trimming technology used to remove excess material, resulting in a contoured proximal edge that may improve flow dynamics and device apposition to the vessel wall when oversizing prevents device expansion to its nominal diameter.

The device also incorporates the Propaten bioactive surface which uses end-point immobilisation of derived heparin to the endoprosthesis luminal surface. This proprietary surface technology preserves the heparin bioactive sites such that they remain free to interact with the blood at the device surface without being consumed. The original Gore Hemobahn Endoprosthesis was introduced to Europe in 1996; the Gore Viabahn Endoprosthesis with Propaten bioactive surface was first approved for use in the EU in December 2008.

“In 1996, the Hemobahn-Viabahn device was the first SFA stent-graft that had good patency rates and it came already in 15cm length,” said Jacques Bleyn, vascular surgeon, Antwerp Blood-Vessel Center, Antwerp, Belgium. “Because long SFA occlusions can be treated endovascularly with the Gore Viabahn device, Gore took the SFA device and made it better: heparin bonded and with a new length of 25cm.”

The Gore Viabahn Endoprosthesis with Propaten bioactive surface is available with a low-profile delivery system that gives interventionalists a more streamlined approach to re-line the peripheral arteries. Its constructed with a durable, reinforced, biocompatible, ePTFE liner attached to an external nitinol stent structure. The excellent flexibility of the endoprosthesis device enables it to better traverse tortuous areas of the SFA and conform more closely to its complex anatomy.

“With all the new advancements to the Gore Viabahn device over the last 12 months, we are pleased to be able to expand this product’s offerings across Europe to include a longer length device,” said Ben Beckstead, product specialist with the Gore Peripheral Vascular Business. “Since the SFA anatomy does vary greatly from case to case, it is important for Goreto be able to provide physicians with the tools and confidence they need to successfully treat their patients.”

Results from the Symplicity HTN-1 study were presented at the late breaking trials session of the European Society of Hypertension (ESH) Annual Scientific meeting in Oslo, Norway. These results showed that blood pressure reduction achieved by renal denervation is sustained for up to two years.

The multicentre study enrolled patients from Australia, the United States and Europe who had persistently elevated blood pressure despite treatment with an average of five medications. Renal vascular safety was assessed by imaging and treated arteries both acutely and chronically for up to nine months. Markus Schlaich of the Baker Heart and Diabetes Institute in Melbourne, Australia, reported that the straightforward endovascular procedure safely produces a mean blood pressure reduction of -33/-15 mmHg at 24 months in the study cohort. Both vascular and renal safety were also carefully assessed in the study and reported during the presentation. No evidence of treatment-related abnormalities or stenoses was reported.

Commenting on these results, Schlaich said, “There is no question that we are having a positive impact on our patients in terms of hypertension, insulin resistance and other risk factors. The results presented today suggest that these effects might be long-lasting.”

Describing the Symplicity catheter’s role in the renal denervation process, Schlaich said: “We have developed a catheter-based device that actually enables us to target these renal sympathetic nerves quite specifically. They run along the renal arteries. With this catheter-based device we can target these nerves, emitting energy into the tissue which kind of silences, or destroys the nerves in the vessel wall, which then leads to a substantial reduction in blood pressure.”

Renal denervation could be a treatment option for the many patients with hypertension who do not respond to conventional drugs.

Ardian are also awaiting the results of the Symplicity HTN-2 trial, a prospective, multicentre, randomised study comparing patients receiving renal denervation treatment to those receiving rigorous medical therapy. The trial enrolled 106 patients and completed treatments in March 2010, with no major adverse events in all 52 patients randomised to treatment. Primary endpoint results are expected by the end of 2010.

Ardian receives 2010 EuroPCR Innovation Award

The annual award, recently presented at the annual EuroPCR meeting in Paris, France, recognises a technology that shows the greatest potential to change the practice of interventional medicine. Previous winners of this honour include Transcatheter Aortic Valve Implant (TAVI) technology and Bioabsorbable Stent systems.

“We are honoured to receive an award from such a prestigious group acknowledging the clinical importance of our new technology,” said Andrew Cleeland, president and CEO of Ardian.

Ardian’s Symplicity Catheter System delivers radiofrequency energy from within the renal artery to block conduction in the surrounding renal nerves, thereby counteracting chronic activation of the sympathetic nervous system. In addition to blood pressure reduction, this treatment has shown promising results for chronic kidney disease, insulin resistance and heart failure. The treatment is performed in the catheterisation laboratory using interventional techniques similar to those used in other endovascular procedures and does not involve a permanent implant. The Symplicity Catheter System has received CE mark approval in Europe but remains investigational in the USA.

Covidien has announced that it has completed the acquisition of ev3 for an aggregate consideration of approximately $2.6 billion, net of cash and short-term investments acquired.

The tender offer expired at midnight, at the end of July 9, 2010. At that time, the depositary for the offer advised Covidien that 100,814,535 shares of ev3 common stock had been validly tendered and not withdrawn, representing approximately 87.7% of the outstanding ev3 common shares. All shares that were validly tendered and not withdrawn were accepted for purchase and paid for in accordance with the tender offer. An additional 4,246,384 shares, or approximately 3.7% of the outstanding ev3 common shares, had been tendered pursuant to notices of guaranteed delivery.

Pursuant to the terms of the merger agreement, COV Delaware Corporation, an indirect wholly-owned subsidiary of Covidien, exercised its option to purchase newly issued shares from ev3 at the tender offer price. Following the purchase, COV Delaware Corporation owned sufficient shares to effect a short-form merger with and into ev3. The merger was completed today and ev3 became an indirect wholly-owned subsidiary of Covidien. Thereafter, ev3 common stock ceased to be traded on the NASDAQ.

This transaction further accelerates Covidien’s strategy of building a world-class vascular platform addressing high-growth markets and positions. Covidien to become a leading endovascular player, with strong positions in both the peripheral vascular and neurovascular markets. The acquisition brings Covidien a comprehensive portfolio of treatment options, including the primary interventional technologies used today: peripheral angioplasty balloons, stents, plaque excision systems, embolic protection devices, liquid embolics, embolization coils, flow diversion, thrombectomy catheters and occlusion balloons.

“The acquisition of ev3 will enable Covidien to significantly expand its presence in the vascular market and is in line with our strategy of becoming a leading partner with vascular surgeons, neurosurgeons, interventional cardiologists and interventional radiologists,” said Richard J Meelia, chairman, president and CEO. With its broad product portfolio, clinical expertise and call-point synergies with our existing vascular franchise, ev3 will be an important addition to our innovative vascular intervention products.”

Covidien will report ev3 as part of its vascular products line in the Medical Devices business segment.

The joint guidelines on standards of practice for embolisation as defined by the Society of Interventional Radiology (SIR), Cardiovascular and Interventional Radiological Society of Europe (CIRSE), and Canadian Interventional Radiology Association (CIRA), were published in the April issue of JVIR (Golzarian et al, April 2010, Vol. 21, Issue 4, pp 436–441).

Marc Sapoval, France, one of the directors of GEST USA, presented some key points on the document at GEST USA 2010. “The guidelines document is a training standard designed to define the way people who are performing embolisation should be trained,” he said.

Sapoval told Interventional News, “In summary, this document covers the clinical, technical and imaging training needed to perform embolisation. On top of that, there is a clear definition of imaging training needed to perform this technically and clinically demanding, minimally invasive procedure. The focus is to ensure that everybody who actually performs embolisation has an appropriate level of training that covers, at least, full imaging training such as radiology certification.

Sapoval shared an excerpt from the document at GEST USA 2010 which read: “Embolisation has grown dramatically in scope and complexity over the past three decades, and with this growth, there is now a need to define standards for those practising in this field including: Appropriate training with monitoring of outcomes; provision of pre-, intra- and post-procedural patient care; and the performance of technical aspects of the procedure.”

He told delegates, “If you have no idea of 3D imaging, or disease conditions other than in your own field, there is a real danger that you will treat an image rather than a patient. Without adequate knowledge and training, there is a high risk that you will apply the wrong technique to the wrong patient. This can result in high complication/failure rates and ultimately, if performed inappropriately, poor acceptance of the technique. The skill needed for embolisation is much more than just using a catheter. We have spent hours discussing the use of embolisation materials. To perform embolisation, we need skills, knowledge and mastery over the equipment, including state-of-the-art imaging capabilities, knowledge of anatomy and radiation protection. High quality fluoroscopy is a must to see very small wires. Mobile C-arms are not appropriate for this intervention.

“Please use this document. It will soon be published in local languages, and I think it will be the basis for clinical privilege if we use it appropriately,” he said.

“Embolisation requires a different skill set from peripheral arterial and venous disease work. Currently, this skill set lies in the domain of interventional radiology. No other specialty really has the ability to train physicians to do this type of work,” James F Benenati, current president of the Society of Interventional Radiology (SIR), told delegates at GEST USA 2010, San Francisco, USA.

He began his talk by saying, “The last of my disclosures is that if you are not an interventional radiologist, and you are listening to this, you might not like some of the things that you are going to hear.” Benenati told delegates that the position SIR took was that, unlike in peripheral arterial disease, embolisation was a very different skill set. “Right now, in 2010, I think it is fairly safe to say that that skill set lies within the domain of interventional radiology. With the exception of one or two areas, such as the embolisation of the internal iliac arteries with endografts, which is performed by a variety of specialists, the knowledge of embolics, the knowledge of visceral catheter skills, imaging expertise, radiation training, procedural management skills are really exclusive to interventional radiology. I do not think this is debatable, and it is fundamentally true,” he said.

He emphasised the importance of relevant training in order to perform this procedure safely and effectively. “While talking about embolisation, we have to ask ourselves what are we really encompassing, how do we want to do it and what are the skill sets required. When you look at this list, it becomes evident that this encompasses a lot more than one type of procedure. There is a wide variety of procedures that we call embolisation. Some of the skill sets may be the same, but there are skill sets and interventional needs that are different for each of these areas and it would be a huge mistake to lump all of this under one type of procedure.” Benenati asked: “Who can do this? Well, within IR, does a fellowship-trained interventional radiologist have the ability to do all those procedures under embolisation? There is a wide variety of fellowships, we do not learn to do all of these procedures with equal expertise in all fellowships.

“The question is what types of skill sets can transfer from one procedure to another. We also need to look at how we can develop standards of practice that will allow qualified MDs to do this work. Better stated, we need to ensure patient safety by making sure that only those who are adequately trained are able to perform these procedures. We are seeing more and more non-IR specialists dabbling in areas of embolisation. This tells me, in some cases at least, that training in embolisation is taking place more on the fly rather than in sanctioned training programmes. Attending a meeting and obtaining a document that one has completed a course in, is simply not sufficient to allow one to begin working in the embolisation field. This is not in the best interest of patient safety or quality.”

Benenati urged interventional radiologists to be active in establishing credentialing early and enforcing it. He said that while the SIR can establish standards and policy documents, it cannot be relied on to fight local battles. He also said that the SIR would collaborate with all specialties in the advancement of patient care, but would not compromise on the embolisation issue. “We do not want to be isolationists, we want to collaborate with other specialties, but we feel strongly in this area that we are the specialists to do this: No one else has demonstrated competence in this area. There are no training programmes other than in IR, which cover the skills associated with embolisation.”

He drew attention to the fact that some vascular surgeons were stepping beyond their levels of organ competencies in order to expand the scope of their practice. “There are cases of other specialties advertising that they are able to embolise fibroids, and this skill has possibly been gained from reading journal articles, attending courses like this and yet they are advertising that they can do this. But they do not have the credentials to do this,” he said.

Benenati also said that the SIR was internally re-evaluating existing training standards in order to deal with the wide scope of procedures that fall under the umbrella of embolisation. Finally, he said, “We must remember lessons learned in the past. Think back 10 years–the water got very bloodied with peripheral arterial interventions. We lost a lot of our turf, partly due to our own fault. At this point, many of us jumped into blue waters, we got into oncology and other areas. But now those blue waters may be threatened. We must be able to clinically manage our patients, understand the disease processes we are treating, and be able to demonstrate our value to referring physicians and administrators. Being an excellent interventionalist is simply not enough. It takes more,” he said.

Ziv Haskal, one of the directors of GEST USA 2010, agreed: “Patients should not be served upon the sacrifical altar of embolotherapy amateurism. This procedure is not a weekend or dilletantish addition to one’s practice, but one, that at GEST USA 2010, we have tried to show, is a complex, diverse, and highly demanding area to specialise in.”

Two of the three directors and organisers of GEST USA, Jafar Golzarian, USA, and Marc Sapoval, France, told Interventional News about some of the key trends that they saw emerging from the meeting in San Francisco, USA.

“Embolisation is a critical part of an interventionalist’s armamentarium. It is absolutely essential. It has come of age practically in a wide variety of indications, for example, gastrointestinal haemorrhage. It is also clearly of value in its incarnation as chemoembolisation and radioembolisation in the treatment of liver tumours.The main thing we have to do is to demonstrate its value in prospective randomised, controlled trials. We have to demonstrate it clearly to the people who pay the insurance companies and the Government, not just to the people who might refer to us, because if you perform a procedure that does not get reimbursed, then it will no longer be performed. So yes, it has come of age in practical terms, but we have to demonstrate its value in real evidence-based terms for some procedures so that people outside of interventional radiology recognise this,” said Matthew S Johnson, USA.

Expanding role of imaging for embolisation

GEST USA 2010 saw that imaging was becoming a key part of all aspects of embolisation. Sapoval said, “The expanding role of non-invasive imaging in embolisation in general, covers both the pre-intervention work-up (especially in acute patients, including trauma, upper or lower gastrointestinal bleed, and haemoptysis) and the role of per intervention image guidance, including cone beam CT and fusion imaging. Imaging also plays an essential role in better understanding the outcome of treatment after embolisation, especially in cancer patients.

“We have been hearing about this for many years, but you do get the feeling from the research and presentations here that there is a global trend, even if you do not have very precise figures that there is an overall consciousness about imaging techniques,” he said.

“I think the cost of imaging is not really known. When we are talking about pre-imaging in acute bleeding patients, the costs are very difficult to consider because patients are dying and a large number of health resources are needed in a short period of time.”

“It is different when you talk about cone beam CT, as this has to be considered, when you buy an angio facility and you need to have additional software, and a flat panel detector, so the system costs more. Up to now, there is no evidence that the additional cost for hospitals or healthcare systems is justified. I believe that it is, at least in some cases, because it is known that in a patient with hepatocellular carcinoma, when you do transarterial chemoembolisation, you can find new lesions with this type of imaging and this alters the way you work, so it is highly likely that it is related to the survival of the patient,” he said.

Combining materials is on the rise

From GEST USA 2010, it has also become clear that the age of puritanism when it comes to the choice of embolic agents is rapidly collapsing. Today’s interventional radiologist has to master the characteristics of a wide variety of materials and also learn to use them in combination with one another to obtain the optimum results. “In our training and daily work, we are now becoming increasingly convinced that there is a place for combining materials. By knowing more about the specifics of each material we can take the combination to a better level. In embolisation for abdominal wall bleeds, trauma or gastrointestinal bleeding, sometimes the lesions should be treated with a combination of coils, gelfoam, or particles. Dr (Robert) White, Dr (Lindsay) Machan and Dr Hunter, in different talks and case presentations, have shown their results of using a combination of coil and sclerotherapic agent to treat varicocoeles. Previously, most IRs used to treat varicocoeles with coils. With more understanding of the vascular system, and rising cost-awareness, we see that leaders in the field are using a combination of materials by placing one or two coils distally in the spermatic vein to prevent the sclerotherapic agent from affecting the testes. They then use sotradecol to embolise all the collaterals and then finish, perhaps, with another coil.

In this way, you use fewer coils, so it is less expensive and still shows a great result,” said Golzarian.

GEST USA has international faculty

Both Golzarian and Sapoval emphasise that GEST USA is one of the only meetings to have over 20 faculty members from Japan and other countries in the Far East. This adds value due to the exchange of experience, they say.One important observation that Golzarian and Sapoval share is that the international aspect of GEST‰ÛöUSA 2010 translates to a huge educational value. “The different types of disease and methods employed to treat them in the East and West are complementary. For instance the hepatocellular carcinoma that the Japanese patients get is mostly due to hepatitis whereas a similar disease in Europe would be mostly cirrhotic, and so it is interesting to confront the differences in approach the treatment of the lesions,” said Golzarian.

Added Sapoval: “What is interesting, more generally, is that we can share the experience of people who have perhaps 10 times the number of patients that we regularly have. This is very striking for some attendees. In the Western world, an interventionist may consider himself an expert if he does 50 cases a year, but some of our fellow interventionists in the East perform something like 500 cases a year. You can really learn a lot from someone like this, if he understands his experience well, and communicates it well. There is definitely complementary input. There are also interesting differences in the manipulation and preparation of certain embolic materials, particularly gelfoam. We see that there are several different approaches and experiences which are specific to different countries, and this is new for other delegates and becomes an important teaching point,” he said.

A consensus was reached on a Global Statement for interventional radiology by an international gathering of interventional radiologists during the 35th Annual Scientific Meeting of the Society of Interventional Radiology (SIR) in Tampa, USA, in March.

The delegation met to consider the approval of a broad statement outlining the identity and scope of interventional radiology (IR) practice across the world. The Global Statement is an effort to put into writing the basic elements of the subspecialty which apply to interventional radiologists anywhere in the world.

The process of outline was begun two years ago by the then SIR president, John Kaufman, and the then CIRSE president, Jim A Reekers. SIR and CIRSE are the two largest IR societies in the world. 

The Statement is described as “deliberately brief” and says “In each country and region, IR practice will vary according to local factors. Furthermore, in some countries, IR will be formally recognised as a unique subspecialty of diagnostic radiology, while in other countries IR will be formally recognised as a distinct radiological specialty. The following are common features of IR as either a subspecialty or specialty.

• Expertise in diagnostic imaging and radiation safety
• Expertise in image-guided minimally invasive procedures and techniques as applied to multiple diseases and organs
• Expertise in the evaluation and management of patients suitable for image-guided interventions included in the scope of IR practice
• Continual invention and innovation of new techniques, devices and procedures

Based on these features, IR is unique and distinct from all other surgical, radiologic, and medical subspecialties and specialties. The Statement also sets out the elements of IR, training, certification, clinical practice, quality, research and professionalism.

It takes more than just the normal dose of expertise to practise in the midst of war, a natural disaster or a place where there is extreme poverty and no infrastructure. But many interventional radiologists, those recognised experts in image interpretation and cessation of blood flow, feel that it is in these and other such extreme situations that the adaptability and ingenuity of the subspecialty comes alive. IRs are typically a hands-on lot, “prepared to turn their hands to almost anything”.

“One of the things we often forget while we get bogged down in current procedural terminology (CPT) codes and all that we do, is how fortunate we are to practise in places that are safe to live in, with wonderful sterile equipment, stable electrical supplies, and use equipment that has not been used before. Many SIR members practise in very tough environments, in emergency situations, and many live in these places. In this session, you will get some sense of the diversity of the environments in which we have to practise,” said Murphy.

Commander Stephen Ferrara, from the US Navy, who had just returned from Afghanistan where he had been involved in setting up the first interventional radiology service, spoke on interventional radiology in Indonesia, following the Asian tsunami. His talk was titled “Radiology Afloat: Experience from the USNS Mercy in Tsunami relief and beyond”.

Ferrara said, “Performing interventional radiology in an austere environment exemplifies the inherent ingenuity and adaptability within this field.”

Ferrara made a critical distinction between “humanitarian assistance” and “disaster relief”.  The former type of medical mission involves primary care work with a heavy emphasis on diagnostic imaging and, in general, “simple” scheduled surgery. All of which usually take place in some form of infrastructure, he said. On the other hand, in “disaster relief, the infrastructure is completely obliterated, and there is much trauma and critical care. However, imaging is still important, as are image-guided procedures,” explained Ferrara.

He created a vivid picture of the striking armageddon-like atmosphere left behind by the tsunami, and working in an angiosuite with heavy seas, rocking and rolling, where image monitors were strapped down for stability. “You encounter interesting challenges which are different from land-based hospitals,” said Ferrara.

He also said there was a huge role for IVC filters in Afghanistan where there was a lot of polytrauma, spine, neurological injury and long-bone trauma. “As these patients cannot get long-term coagulation, we felt the best thing to do for them in order to prevent potentially fatal pulmonary embolisms, was to put filters in them,” he said.

In situations like this, Ferrara told delegates: “Be prepared to function a lot outside of your traditional role and comfort zone and to do a lot of women and child care.” He described a case involving an infant with pneumothorax at a time when there was no paediatric intensivist or anaesthesiologist present.“I was the only one willing to put a chest tube in the baby, no-one else felt comfortable, so this is where you will find that interventional radiologists will usually do pretty much anything,” he said.

Then, Matthew S Johnson, Indiana University School of Medicine, USA, spoke about the long journey which took interventional radiology to the Moi Teaching and Referral Hospital in Eldoret, Kenya.  “When I first went there in 2003, I realised there was no need for IR, because there was no radiology. The chest X-rays were the property of the patients, who had paid for them, and they were kept under the mattresses, or with them. There were no radiologists to read them; the doctors read them at the bedside through the windows.”

Johnson pointed out that there were as few as 70–90 radiologists in the entire country. More than 50% of those are in Nairobi, the capital, and fewer than 45 in the rest of Kenya.

“There are many challenges to IR in Kenya. There are very few radiologists, there is lack of clinical training in radiology, very little equipment, and frequently when it is there, it does not function. There is also very little money, so a CT scan which could cost up to 80 dollars is clinically irrelevant. There is also inadequate record keeping, in that, once a radiologist read an image, they would write on a piece of tissue paper that got thrown away.”

Johnson then spoke about the  people he worked with, and their difficult journey together, which has led to the setting up of a Picture Archiving and Communication system (PACS) system, where outside clinics now send X-rays,  getting a new multislice CT scanner and other equipment in the hospital.

He talked about cases where without IR, patients would have died, such as the 26-year-old woman with HIV, and ascites which was attributed to liver failure. That diagnosis prevented treatment of her HIV. However, when liver function tests came back normal, ultrasound showed massive ascites.  Johnson and team placed a percutaneous peritoneal drain where 25 litres of pus drained in just 16 hours. Sonosite suggested an intraloop tubercular abscess and the patient went to the operating room to drain the abscess and was then released on highly active antiretroviral treatment.

Johnson spoke of how over the course of time, he has seen Kenyan radiologists such as Livingstone Wanene become committed to the cause of interventional radiology. “He is now the “go-to” guy in Kenya for biopsies and nephrostomies, and is involved in training people,” he said. Johnson also spoke about the donated equipment which is “re-used and re-used till it breaks”.

Johnson told delegates about the high incidence of cancer, and gave an example, of young women with cervical cancer and ureteral obstruction which precluded chemotherapy. “We did nephrostomies using only ultrasound guidance. It can be done and is so important, because now those young ladies are getting nephrostomy tubes, and then chemotherapy.  They would otherwise have been sent home to die,” he said.

SIR attendees learned that “There is a lot of promise, but then there are several problems, including the possibility of the hospital going bankrupt.”

Johnson’s last slide was a copy of an email he received from Livingstone Wanene telling him about his pride and humility in performing three percutanous nephrostomies. It read, “[…] your faith in the fact that one day interventional radiology will be a medical aspect for Eldoret is not for naught. Eight years has been a long incubation period, but we are now good to go. So what next?”

SIR delegates then listened to a recorded session by Aghiad Al-Kutoubi of the American University of Beirut Medical Center, Lebanon, on the Lebanese experience who began by acknowledging the contribution of all the staff who risked their lives.

Al-Kutoubi shared that Lebanon went through several difficulties in the last 50 years —the 15-year Civil War (1975–1990), the Israeli invasion of Lebanon and Beirut (1982) and the Israeli war against Lebanon (2006). He told delegates, “We had to handle variable injuries relating to type of battle and type of weapons used. Frequently, there were problems with victim transportation which was hampered by ongoing hostile activities.‰ÛöWe also faced direct pressure from families and comrades to intervene, even in hopeless cases, sometimes with a weapon pointed to our heads.”

In the Civil War period, said Al-Kutoubi, the weapons used were machine guns and grenades which resulted in heavy artillery injuries. The victims brought for treatment had manageable injuries and it was seen that vascular, intracranial and abdominal sites of injury were suitable for imaging and intervention. So there was a major role for interventional radiology to play.”

On the other hand, said Al-Kutoubi, in the Israeli wars on Lebanon, the weapons used were heavy rockets, bombs, heavy artillery bombardment from tanks, ships and airplanes, and landmines. These resulted in  massive injuries, with the victims frequently being unrescuable. “As such there was a limited role for IR and imaging, except for victims on the periphery of the area of damage,” said Al-Kutoubi.

He said the most important aspect for the team was agreeing triage and management protocols, staff issues, safety issues, equipment and devices, safety of patients during transport, and rapid and focussed imaging/intervention.

The hospital had to ensure that staff had transportation, accommodation, contact with their families, and protection during the hostilities outside. The team also had to ensure that equipment, power supply, and access were maintained.

“When it came to supplies and devices, we used to store and hoard as much as possible. We had “black market” contacts for supplies and had to use our existing resources like coils and tubes with creativity.  We made our own catheters from tubing, and re-used them maybe 30 or 40 times, and used pieces of guide wires instead of readymade coils.

 “In addition, we had to do our regular duties, maintain diagnostic imaging, consultations, consider modern imaging requirements, train residents, keep up-to-date  and,” Kutoubi continued, “through it all live for the moment and look for the light at the end of the tunnel.”

“Until now, there has been no single document – no blueprint – defining interventional radiology that has had broad international support. It was time for interventional radiology to organise itself, worldwide, as a single family,” said James F Benenati, president of the Society of Interventional Radiology (SIR). SIR represents 4,500 US doctors, scientists and allied health professionals dedicated to improving health care through minimally invasive treatments.

Interventional radiologists offer the least invasive and most advanced treatment options for major health problems (including cancer, cardiovascular and venous disease, spine fractures, stroke and uterine fibroids), but many may not be aware of these advances. However, interventional radiology is not formally recognised as a “real” specialty or subspecialty in some countries. “Global Statement Defining Interventional Radiology” sets out to offer an universally accepted definition of the discipline, including details such as IRs’ expertise in diagnostic imaging and radiation safety, image-guided minimally invasive procedures and techniques as applied to multiple diseases and organs, the evaluation and management of patients suitable for the image-guided interventions included in the scope of IR practice and the continual invention and innovation of new techniques, devices and procedures. “When you have an inclusive, multinational document that represents more than 10,000 doctors worldwide, it is hard to deny their existence,” said Benenati, an interventional radiologist and medical director for the Noninvasive Vascular Laboratory at Baptist Cardiac & Vascular Institute in Miami, USA.

Work on the collaborative statement began two years ago by then SIR president John A Kaufman and his European counterpart, Jim A Reekers, then president of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE).

“The goal is a document backed by interventional radiology societies all over the world stating, ‘This is what constitutes the specialty of interventional radiology,’” said Kaufman, professor at the Dotter Interventional Institute, Oregon Health & Science University, Portland, USA. “We expect that the document will be translated and published widely throughout the world.”

This marks the company’s first clinical trial in the USA for a premarket approval (PMA) device. A unique feature of the clinical trial is that it will simultaneously enroll patients in USA and Japan.

Terumo has recently announced it has received an investigational device exemption (IDE) conditional approval from the USA Food and Drug Administration (FDA) for its OSPREY(Occlusive/Stenotic Peripheral Artery Revascularization Study) in the USA, which will evaluate the safety and effectiveness of the Misago self-expanding stent system for use in the superficial femoral artery (SFA). This marks the company’s first clinical trial in the USA for a premarket approval (PMA) device. A unique feature of the clinical trial is that it will simultaneously enroll patients in USA and Japan. Referred to as “Medical device collaborative consultation and review of premarketing applications” under the larger “Harmonization by Doing” initiative, Terumo’s trial was selected as one of two projects to pilot this approach, which is intended to shorten the gap between product approvals in these two significant world healthcare markets.

The initiative is an international effort to develop global clinical trials and address regulatory barriers that may be impediments to timely device approvals. This process is a cooperative effort to move both Japan and USA toward international regulatory harmonization by seeking regulatory convergence between FDA and Japan’s regulatory bodies MHLW-PMDA. The learning obtained in the “proof of concept” trials will assist both regulatory bodies in streamlining the clinical trial process for faster approvals in both countries, as well as promote the idea of global trials for purposes of collecting better data. In this pilot harmonisation study, the products will be submitted for review and approval at the same time.

“I believe this approach to shorten the time for new product approvals between USA and Japan is critical and exciting,” said Takao Ohki, chairman and professor, Department of Surgery, Jikei University School of Medicine, Division of Vascular Surgery, and the global principal investigator of the OSPREY trial. “This innovative movement could dramatically solve the current device lag issue between our countries.”

In the USA, OSPREY is a single-arm, multicentre, non-randomised prospective clinical trial for the treatment of atherosclerotic stenoses and occlusions of the SFA. In Japan, there are two arms of the study, 50 patients receiving the Misago stent and 50 patients receiving percutaneous transluminal angioplasty (PTA).

The primary endpoints of the OSPREY in the USA are:

• Primary stent patency rate at one year as confirmed by duplex ultrasound or angiography.
• Freedom from major adverse events within 30 days of the procedure, which would result in target lesion revascularisation, amputation of the treated limb, or death.

The study will include up to 350 patients, a maximum of 250 patients in up to 30 centres in USA and 100 patients in Japan. There have already been six patients enrolled in Japan, which received regulatory approval to begin the trial last year. The first enrollments in the USA are expected in June 2010. The principal investigator in USA is J Fritz Angle, associate professor of Radiology, University of Virginia.

The MISAGO self-expanding stent consists of a nitinol stent pre-mounted on the distal portion of a rapid-exchange delivery catheter system. The stent has three radiopaque markers located on each end of the stent to help ensure accurate placement in the lesion. The stent is currently available for sale in Europe.

Revolutionary device delivers consistent performance, better control, and minimised blood loss during endovascular procedure.

Gore has recently announced the first patient case involving the revolutionary Gore DrySeal Sheath. The sheath aids in minimally invasive treatment for patients with abdominal aortic aneurysms (AAA) with the Gore Excluder AAA endoprosthesis and thoracic aortic aneurysms (TAA) with the Gore TAG thoracic endoprosthesis. The successful procedure was performed by Alan Lumsden, chairman of the Department of Cardiovascular Surgery, The Methodist Hospital in Houston, USA, during a Gore-sponsored Acute Symptomatic AAA Workshop conducted in The Methodist DeBakey Heart and Vascular Center.

Gore received FDA clearance in April 2010 to market the Gore DrySeal Sheath, which comprises the innovative haemostatic Gore DrySeal Valve attached to the introducer sheath. The Gore DrySeal Valve is truly unique in that it is pressurised to create a seal, thereby minimising blood loss and accommodating multiple wires and catheters simultaneously. The valve consists of a silicone outer tube and an inner film tube that create an effective haemostatic seal that easily adapts to the profiles of the inserted devices. The device is available in profiles from 12 to 26Fr, in 2Fr increments, and has a working length of 28cm.

According to Lumsden, “The ability of the Gore DrySeal Valve to accommodate multiple devices during difficult procedures with minimal blood loss keeps the operating field free from excess blood, while helping to prevent unnecessary blood loss to the patient. The Gore DrySeal Sheath requires no intra-procedural manipulation of the valve, delivering consistent performance throughout the procedure and allowing the physician to maintain focus on the endovascular procedure – without being concerned about blood loss at the patient access site.”

Gore Aortic business leader David Abeyta added, “This latest addition to Gore’s portfolio of world-class endovascular devices and accessory products minimises patient blood loss during procedures with endovascular devices, such as the Gore Excluder AAA endoprosthesis.”

The stent is now indicated for treatment of peripheral disease in the iliac arteries

Broadening the scope of innovation for cardiovascular interventions beyond the heart, Medtronic has recently announced that it has received approval from the US Food and Drug Administration (FDA) for the Complete self-expanding vascular stent system to be used for the treatment of peripheral arterial disease (PAD) in the iliac arteries. “The Complete vascular stent system provides physicians with a new treatment option that offers significant benefits for patients with narrowed iliac arteries due to peripheral vascular disease,” said Robert Molnar of Michigan Vascular Research Center in Flint, USA. “The system enables highly accurate stent placement in the iliacs, reducing the likelihood of stent ’jumping,’ which we commonly see during deployment with the use of many self-expanding stent systems.”

Molnar and William Gray, director of endovascular intervention at NewYork-Presbyterian Hospital/Columbia University Medical Center, led the study (as co-principal investigators) who contributed to this approval.

The Complete self-expanding vascular stent system features several novel advances, including an innovative dual-deployment delivery system with a unique triaxial design. The new delivery system is made up of an inner shaft, a retractable sheath and a stabilising sheath that reduces friction and allows the retractable sheath to move back freely. This decreases the amount of force required to deploy the stent, thereby making deployment easy and precise.

“FDA approval of the Complete stent for a peripheral indication marks a successful milestone in our peripheral arterial disease clinical research programme,” said Sean Salmon, vice president and part of the CardioVascular business, at Medtronic. “Following our acquisition of Invatec, this approval augments Medtronic’s offerings in a large and growing market where patients are significantly under-diagnosed and could benefit from expanded treatment options.”

In other areas of Medtronic’s peripheral arterial disease clinical research programme, physicians are progressing with enrollment in two additional indication-specific trials, one investigating the use of the Complete stent for the treatment of superficial femoral artery stenoses, and the other studying the balloon-expandable Assurant Cobalt stent in treating iliac artery disease.

Patients suffering from blockages of the renal arteries, a condition often leading to high blood pressure and kidney failure, may one day enjoy the clinical benefits of the latest drug-eluting stent technology if a new clinical trial proves the safety and efficacy of a new generation of these devices.

Cook Medical has enrolled the first patient in its landmark Formula PTX clinical trial. The trial is the first of its kind to evaluate the safety and effectiveness of a paclitaxel-eluting, polymer-free stent to treat renal artery disease, the narrowing of the arteries that supply blood to the kidneys. The multi-centre, randomised trial plans to enrol 120 patients at sites across Europe and initial results are expected in Q4 of 2010.

The trial utilises Cook’s Formula renal stent, which is designed with a very low profile that may help it cross tightly blocked vessels for placement into diseased renal arteries. The stent is a slotted tube constructed of a medical-grade stainless steel that is mounted onto a balloon catheter specifically designed for the stent. Once placed at the site of the blockage, the balloon is inflated, expanding the stent and opening the vessel. The balloon is then deflated and withdrawn, leaving the stent behind to act like a metal scaffold to hold open the vessel and restore blood flow.

The choice of paclitaxel for the Formula PTX Balloon Expandable Renal Stent follows the proven results of the world’s largest clinical trial of its kind for Cook Medical’s Zilver PTX drug-eluting peripheral stent for the treatment of peripheral arterial disease (PAD) in the superficial femoral artery (SFA). The CE marked Zilver PTX is clinically proven, polymer-free and exceptionally durable, delivering paclitaxel to the cells in the vessel wall to reduce the risk of new blockages forming.

“The proven clinical results of the Zilver PTX have shown the success of polymer-free paclitaxel elution in treating blockages in the peripheral arteries. Applying this technology to other devices, like the Formula balloon expandable renal stent, has the potential to significantly help patients in the battle against renal artery stenosis,” said Rob Lyles, vice president and global leader of Cook Medical’s Peripheral Intervention business unit. “Cook Medical is committed to enhancing the delivery of care to patients and we are looking forward to the initial results from the trial later this year.”

Professor Dierk Scheinert, Angiology and Cardiology Specialist at participating hospital, Park-Krankenhaus Leipzig-South, said: “Following Cook Medical’s success with the Zilver PTX, we chose to be involved in the clinical trial for the Formula PTX balloon expandable renal stent. Given the early success of the US REFORM clinical trial evaluating the Formula balloon expandable stent, we remain very excited about the potential of a drug-eluting renal stent. Providing physicians with a greater range of devices will ultimately help patients receive the best possible treatment options.”

Physicians have treated more than 1,250 patients worldwide with the Zenith TX2 TAA Endovascular Graft with Pro-Form, the first-of-its-kind device from Cook Medical designed specifically to repair thoracic aortic aneurysms in anatomies with tight arches as well as conventional cases. Cook’s new Zenith graft, which received FDA approval in May 2009, provides an advanced treatment solution for a life-threatening condition that is diagnosed in 15,000 patients in the USA, each year.

Physicians say they are embracing TX2 with Pro-Form because the graft is designed to enhance treatment in patients whose tight aortic arches pose special difficulties for thoracic endovascular repair (TEVAR) but who cannot tolerate open surgical intervention “Twenty five percent of patients with thoracic aortic aneurysms, mostly women, have narrow ‘gothic’ aortic arches,” said Benjamin Starnes, associate professor of surgery and chief of vascular surgery at the University of Washington in Seattle.

“Zenith TX2 with Pro-Form expands the effectiveness of TEVAR within this large subset of patients and opens the door to future innovations that will address other anatomical challenges physicians frequently encounter in potential candidates for this treatment. With its ability to provide physicians with highly controlled device deployment, TX2 with Pro-Form helps ensure the endograft conforms to, and presses against, the aortic wall and repairs the aneurysm without the ‘bird’s beak’ effect seen in some earlier thoracic endografts.”

Thoracic aneurysms occur when a section of the aorta weakens and bulges outward, creating a risk of severe internal bleeding. Only 20-30% of patients who arrive at the hospital with a ruptured aneurysms survive. Unfortunately, many endografts are too rigid or possess sealing stents that lack the radial force to conform correctly to the inner curvature of tight aortic arches. Surgeons must therefore remodel the arch with a balloon or other aids to reduce the risk of continued bleeding and possible rupture.

TX2 with Pro-Form is designed to alleviate the need for such complicated measures. Featuring an improved delivery system specifically engineered for patients with tight arches, Zenith TX2 with Pro-Form provides physicians with greater levels of control during endograft deployment to help establish proximal conformity of the device to the aortic wall. As a result, the device helps prevent the “bird’s beak” gap that prevents proper sealing of the aneurysm, leading to more viable aneurysm repair and restored aortic blood flow.

“Zenith TX2 with Pro-Form technology is a direct result of our collaboration with physicians who told us what they needed in order to expand treatment and improve outcomes for aneurysm patients,” said Phil Nowell, global leader of Cook Medical’s Aortic Intervention business unit. “Cook is the first to address this particular challenge to TEVAR, and the response from the medical community is extremely positive.”

A small study comparing efficacy of four well-known embolic agents for UFE raises interesting questions and finds that outcomes with cheaper gelfoam were similar to those with Embospheres and Embozene in terms of infarction rates. Bead Block was shown to be less effective.

A prospective non-randomised single-centre study carried out between May 2006 and March 2009 by Nigel Hacking, Timothy Bryant and Brian Stedman in Southampton, UK, compared the clinical and radiological outcomes of uterine fibroid embolization (UFE) performed with either Bead Block, Embospheres, Embozenes or gelfoam.The study found that embolization with gelfoam resulted in comparable rates of complete dominant fibroid infarction with Embospheres and Embozene (85%, 90%, 95% respectively).Bead Block resulted in lower rates of complete dominant fibroid infarction (50%).

Results of the study were presented at the 35th Annual Scientific Meeting of the Society of Interventional Radiology, Tampa, USA.

The investigators concluded that “The choice of embolic agent used in UFE not only has an impact on radiological outcomes but has significant cost implications. Our small study has demonstrated similar outcomes for embolic agents of notably different cost.”

Timothy Bryant, Southampton University Hospital, who presented the study, told Interventional News: “This study was designed as a pilot study with the aim of guiding future larger randomised multicentre trials and as such the results have to be interpreted with this in mind. Certainly it has raised several interesting points. In our small group, gelfoam outcomes were similar to other more expensive embolics in terms of infarction rates. Increased rates of uterine artery occlusion were noted on follow-up in the gelfoam group which is in itself interesting considering that gelfoam is thought to be a temporary agent. The postulation is that this is related to vascular inflammation caused by the embolic, although we have no histological proof and the significance is not known. Considering this, perhaps gelfoam would be better used in the older patient cohort where there is less chance of having to reintervene and where fertility is less of an issue.”

Bryant also commented that gelfoam is not as amenable as spherical particulate embolics to injection through a microcatheter, which is a consideration given the increased usage of microcatheters amongst UFE practitioners.

Study design

Investigators included patients who presented with symptomatic fibroids suitable for UFE. The patients were then divided on a sequential basis into four groups of 20. UFE was carried out with either gelfoam (group I), Embospheres (group II), Bead Block (group III) or Embozenes (group IV).

Pelvic MRI was performed prior to UFE and at three to six months post-UFE. MRI included: T2W, unenhanced axial T1 FS, post gadolinium FS T1 and MRA sequences. Uterine volume, dominant fibroid volume, overall fibroid infarction, dominant fibroid infarction and uterine artery patency were assessed by MRI.

Results

In groups treated with gelfoam, Embospheres and Embozenes (I, II, and IV), comparable rates of dominant fibroid complete infarction (85%, 90%, 95%) and overall complete fibroid infarction (70%, 80%, 70%) were seen.

With the group treated with Bead Block, investigators saw lower rates of dominant fibroid complete infarction (50%) and overall complete fibroid infarction (44%). Dominant fibroid volume reduction and uterine volume reduction were comparable between the groups. No correlation between VSS improvement and embolic agent or radiological outcome was demonstrated.

Commenting on the results, Bryant said, “Given the size of our study and lack of randomisation, it is difficult to draw definitive conclusions. The question is still wide open as to which is the most efficacious embolic, if in fact any are significantly better, in UFE. The fact that our gelfoam data supports what already exists in the literature in terms of satisfactory fibroid infarction rates makes it an attractive option, particularly within the older patient cohort.

“Also in respect to our trial there are other embolics that we have not yet investigated, including particulate PVA which is currently in widespread use in the UK and Canada and favourable on a cost basis,” he said.

“I think a large randomised multicentre trial is needed to answer these ongoing questions. The literature does show similar outcomes for many of the embolics in terms of fibroid infarction rates and symptomatic improvement, but there has been no large scale direct comparison. Other subsets such as periprocedural pain scores, volume of embolic required, post-procedural uterine artery patency, fertility, effect on ovarian function and post-embolization volume reduction should also be compared.”

Issue of cost

Bryant said, “There is a vast array of available embolic agents with a wide range of costs. The embolic is the most costly element of the UFE procedure and as such it is important to know that the one being used is both cost and clinically effective. Therefore informative comparative trials are essential to guide us.”

Nigel Hacking, principal investigator of the study said, “The message that gelfoam is an economical and effective alternative is particularly important in the developing world where I have set up a service in the Caribbean and have treated over 900 patients. I have also just set up a similar service in East Africa and am heading out there in April to treat the next batch of women. Gelfoam is all these countries can possibly afford and it is important that they do not think they are getting a cheap and ineffective option.”

Choice of embolic

Interventional News asked Bryant what advice he would give a young interventional radiologist looking to start embolization.

“Study the literature. There are a wide variety of embolics to choose from. They should pick the most appropriate for the case. Cost is a consideration, but the driving force should remain what is best for the patient. In general, for fibroid embolization the current consensus points towards the use of spherical embolics including Embospheres and Embozenes or particulate PVA. Despite ours and previous results, Robert Worthington-Kirsch’s recent study may also promote renewed interest in Beadblock using different sizes and endpoints from those formerly accepted. In the Far East there is widespread use of gelfoam in UFE with good results in the literature, but there is little in the way of evidence in the rest of the world. It is important to be aware that spherical embolics do not all have the same properties and as such have different size recommendations and embolization endpoints. This needs to be taken into account and the radiologist should be guided by the manufacturers’ recommendations when using their embolic to obtain the optimal results,” he said.

Robert Worthington-Kirsch, who presented comparative results for Embospheres and Bead Block at CIRSE 2008 commented: “Bead Block is softer than Embospheres so the same size is effectively a smaller sized particle. In my experience if you use the best technique, the two embolic agents combined with sensible endpoints, then you get identical optimum performance in embolization.”

Michael Dake, Stanford, California, USA told delegates at the Society of Interventional Radiology’s 35th Annual Scientific Meeting in Tampa, USA, about the initial observations recorded after endovascular treatment of venous stenotic lesions implicated in multiple sclerosis (MS).

“I would like to introduce you to a hypothesis that is not exactly new, but that is getting a lot of high-profile exposure in the lay press. It has to do with the potential association between MS and extra cranial venous obstruction. This is not yet a comprehensive understanding, but this is truly a work in progress that is being played out in real time across the world right now,” said Dake.

What is the rationale that supports the association between multiple sclerosis and venous obstruction?

Dake said it has long been known that MS plaques are venocentric as the lesions have been found to extend counter to normal venous flow direction. Also, the distribution of lesions is often peri-ventricular, and peri-venous cuffs similar to the appearance noted in chronic venous disease are seen.

“The blood-brain barrier breakdown is also at the core of our current understanding of MS whether you consider a vascular pathogenesis or an immune reactive autoimmune basis, which forms our current understanding,” he said.

Dake pointed out that the new conceptual framework was based on the understanding that the vessel wall responds dynamically to changes in flow and pressure (pulsatile shear stress and cyclic strain).

“Alterations in venous flow and pressure may elicit inflammation, thrombosis and tissue injury. Anatomical anomalies in cerebrovenous drainage alter cerebrovenous flow patterns and pressure.These alterations cause increased expression of endothelial adhesion molecules, chemokines, cytokines, and prothrombotic factors; increased smooth muscle injury response and generation of oxygen-derived free radicals; adherence of immune cells and their infiltration into the surrounding tissue; infiltrating immune cells elaborate cytokines and oxygen-derived free radicals that further increase vascular permeability, leading to insudation of plasma proteins and in some cases red blood cells; and parenchymal injury due to inflammation and oxidative stress with demyelination, resolving with fibrosis and plaque formation,” he said.

Referring to the preliminary outcomes from endovascular management of extra-cranial venous insufficiency, Dake said, “This remains to be seen, but clearly global symptoms attributable to MS, but not referrable to a neuro-anatomic loci, such as fatigue, headache, heat sensitivity,‘brain fog’ and urinary urgency, show short-term improvement and in some cases complete resolution. This suggests that these particular MS symptoms may be more accurately categorised as related to venous obstruction.”

Dake told delegates that it was important to remember that lesion sites appeared to be non-specific (dural sinus, jugular, brachiocephalic, azygous veins alone or in combination) and also that lesion etiology is non-specific (congenital/hereditary, osseous impingement, arterial compression, post-inflammatory, arachnoid granulation, etc., alone or in combination).

Chronic cerebrospinal venous insufficiency (CCSVI) is characterised by combined stenoses of the principal pathways of extracranial venous drainage, including the internal jugular veins and the azygous vein. It is strongly associated with MS.

Paolo Zamboni, University of Ferrara, Italy, has been evaluating the safety of CCSVI endovascular treatment and its influence on the clinical outcome of the associated MS. He presented the rationale and preliminary results of an endovascular treatment for MS at the 31st Charing Cross International Symposium, London, UK in 2009.

He said that though MS is an inflammatory neurodegenerative disease of the central nervous system of unknown origin − widely considered to be autoimmune in nature−it is strongly associated with chronic cerebrospinal venous insufficiency. He has emphasised the need for more research in the area and noted that it is still not proven whether CCSVI is a cause of MS, or a product of MS.

Zamboni’s study with 65 patients found that percutaneous transluminal angioplasty of venous strictures in patients with CCSVI is safe, and the clinical course positively influenced clinical and quality of life parameters of the associated MS.

Based on the results of this pilot study, the Italian investigator has recently called for further study that CCSVI may be corrected by endovascular means. He has suggested that if further evidence supports the link between MS and CCSVI, endovascular treatment of the latter may ultimately add to the arsenal of therapies available for MS.

New study evaluates effectiveness of elective unilateral uterine artery embolization (UAE) in women whose fibroids are limited to one side of the uterus and supplied by only one uterine artery.

While indications for unilateral embolization are uncommon, in the rare case when unilateral fibroid disease is present and arterial supply to the fibroids is from a single uterine artery, intentional unilateral embolization may be effective, suggests a study presented at the 35th Annual Scientific Meeting of the Society of Interventional radiology in Tampa, USA.

Luke E Stall, Georgetown University Hospital, Washington DC, USA, who presented the study, said analysis had shown that select patients could effectively be treated by elective UAE. He added that patients undergoing such a procedure experienced less post-procedure pain and that unilateral embolization could provide a greater margin of safety.

Stall quoted from the literature (Ravina et al. Arterial embolisation to treat uterine myomata. The Lancet. 1995 Sep; 346: 671-672) to highlight that there was a common perception that bilateral embolization was required for success regardless of fibroid burden or blood supply, and concern that the fibroids would not completely infarct without bilateral embolization .

Stall told delegates that an earlier study by Bratby and Walker (Outcomes after unilateral uterine artery embolization. Cardiovasc Intervent Radiol 2008; 31: 254-259) was the first to report elective unilateral uterine artery embolization. Bratby et al reported better clinical and imaging outcomes with the elective (30 patients) vs. failed catheterisation (12 pts). They concluded that “unilateral UAE can achieve a positive clinical result in the group of patients where there is a dominant unilateral artery supplying the fibroid(s), in contrast to the poor results seen following technical failure.”

The Georgetown University Hospital investigators carried out a retrospective review of 1290 patients treated with uterine artery embolization for symptomatic leiomyomata from September 2004 through July 2009. The study identified 75 patients who underwent unilateral uterine artery embolization. Most of these patients had an absent uterine artery and some had a failure of catheterisation of one uterine artery. However, 28 had intentional embolization of a single uterine artery because of unilateral fibroid disease on MRI and arterial supply to the fibroids from only the ipsilateral uterine artery on angiography. In all cases, routine embolization using micro-catheters and bilateral femoral puncture was performed.

Stall said outcome measures included peri-procedural pain, fluoroscopy time, clinical and post-procedure MR imaging outcomes. Twenty-five patients returned for three month clinical and imaging follow-up. Improvement in their symptoms was evaluated with a standard post-procedure questionnaire. Their outcomes were compared to a randomly selected control group of patients undergoing routine bilateral embolization.

Results of the Georgetown University Hospital study found that in the immediate post-embolization period, there was less pain among those with unilateral embolization versus routine bilateral embolization (VAS score 3.7 unilateral embolization vs 5.7 for bilateral embolization, p = 0.003) and they required less morphine for pain management.Unilateral emoblization also required less fluoroscopy time than bilateral (10.9 minutes vs 13.4 minutes, p = 0.013). Imaging follow-up showed that 23 of 25 patients (92%) who returned for post-embolization contrast enhanced MRI had complete infarction of their fibroids. Two of 25 patients (8%) had incomplete infarction of fibroids, with neither having greater than 25% residual enhancement. Twenty-five patients completed three-month clinical follow-up. Of these patients, six were very satisfied, sixteen patients were satisfied, two patients were neutral, and one patient reported dissatisfaction with the procedure. There were no other differences in the outcomes of these patients between the two groups.

Stall said, “Symptom resolution in these unilateral embolization patients was similar to that seen in previously published studies of patients undergoing bilateral uterine artery embolization.”

In the United States, more than 100,000 amputations are performed each year on individuals with critical limb ischaemia, the most severe form of peripheral arterial disease. The number one priority in treating these patients is to re-establish blood flow to avoid limb amputation. Interventional radiologists have found that a subgroup of patients with critical limb ischaemia may avoid amputation through the use of drug-eluting stents on the smaller arteries below the knee, according to a study released at the Society of Interventional Radiology’s Annual Scientific Meeting in Tampa, USA.

Drug-eluting stents are an emerging technology that offers hope to peripheral arterial disease patients with critical limb ischaemia and freedom from major amputations. The placement of drug-eluting stents in the infrapopliteal leg arteries is safe and effective and can significantly impact their care. Our results rival bypass surgery and are better than balloon angioplasty alone,” said Robert A Lookstein, an interventional radiologist and associate director of the division of interventional radiology at Mount Sinai Medical Center in New York, USA. Primary patency for the 53-patient study at 12 months was 81.8% (45/55), said Lookstein, who is also an associate professor of radiology and surgery at Mount Sinai School of Medicine. Freedom from major amputation at follow-up was 90.6% (48/53) for the entire group and 100% (44/44) for patients with Rutherford category 4 (ischaemic pain at rest) and 5 (lower-extremity ischaemia associated with minor tissue loss) disease.

The Rutherford categories are a severity classification scale for peripheral arterial disease that can be used to evaluate clinical improvement. Patients were followed for an average of 17 months.

“Currently patient follow-up out to 24 months is incomplete and will be finalised by the end of the year,” Lookstein said.

Late in 2009, preliminary results from the DESTINY trial showed that at six-month follow-up, drug-eluting stents had a higher primary patency rate in below-the-knee critical limb ischaemia lesions compared to bare metal stents. This provoked the question of whether the awaited 12-month angiographic results will confirm the benefits of drug-eluting stents or whether there would be a setback for drug-elution.

Several researchers have been spurred on by the initially promising results of sirolimus-eluting stents in the coronary arteries and have applied them in the infrapopliteal arteries in order to fight restenosis and prolong amputation.

Recently published data from controlled trials of sirolimus-eluting stents have shown favourable results at six and 12 months, with superior angiographic patency and fewer re-interventions compared to bare metal stents.

Siablis et al have carried out a non-randomised prospective single-centre study comparing sirolimus-eluting to bare metal stents in 29 patients with critical limb ischaemia assigned to each study arm (65 bare vs. 66 sirolimus-eluting stents) after suboptimal angioplasty or flow-limiting dissection. Six-month results have shown that sirolimus-eluting stents had significantly higher primary patency and decreased in-stent binary restenosis. Results of this study at one year have proved to be just as optimistic, showing superior primary patency and less in-stent restenosis.

The investigators reported no significant differences between the sirolimus-eluting and bare metal stent groups with respect to one-year mortality, minor amputation, and limb salvage, but the rate of target lesion revascularisation was significantly less in the sirolimus-eluting stent group, both at six months and one year.

Siablis et al also recently reported long-term outcomes from an extended study with more than 100 patients. In this study, follow-up out to three years, showed that  sirolimus-eluting stents were associated with significantly higher primary patency and improved target lesion revascularisation-free survival compared to bare metal stents.

Similarly, Scheinert et al have found in a non-randomised single centre study that primary sirolimus-eluting stent placement is more effective than bare stents for select infrapopliteal lesions. The study enrolled 60 patients, the majority of whom had critical limb ischaemia. Patients were treated with either sirolimus-eluting or bare metal stents. At six months, restenosis and target lesion revascularisation were much lower in the sirolimus-eluting stent group. Overall limb salvage was not remarkably different between the two study groups.

Surgical bypass remains the mainstream therapy for tiny blocked infrapopliteal arteries, but there are a growing number of patients who are unable to undergo this treatment because of their medical problems, said Lookstein. Attempts to treat critical limb ischaemia in peripheral arterial disease patients with below-the-knee angioplasty are hindered by high rates of restenosis, the need for repeat treatments and the continued progression of atherosclerotic disease. Drug-eluting stents are a potential solution to the limitations of endovascular treatment. An interventional radiologist performs a balloon angioplasty to open a narrowed blood vessel and then places a drug-eluting stent in that artery. The stent acts as scaffolding to hold the narrowed artery open. Drug-eluting stents slowly release a drug for several weeks to block cell proliferation and regrowth, thus inhibiting restenosis.

Over a four-year period, Lookstein’s group at Mount Sinai Medical Center in New York studied 53 patients (32 men, 21 women) ranging in age from 43 to 93 who underwent implantation of 94 drug-eluting stents (80 sirolimus, 12 evirolimus, two paclitaxel) to treat a suboptimal angioplasty result in an infrapopliteal artery. All patients had symptoms of critical limb ischaemia with Rutherford grade 4 (15), 5 (29) or 6 (9) disease at presentation prior to treatment. Initial technical success rate was 100% with all treated lesions having less than 10% residual angiographic stenosis at completion of the procedure. The mean number of stents placed per patient was 1.62 (range, 1–5), with the stent diameter ranging from 2.5 to 4mm. Angiographic, clinical and noninvasive vascular examination results were collected prospectively at regular intervals. Primary endpoints, including technical success of the revascularisation procedure, primary patency, freedom from major amputation and survival at follow-up, rival those of conventional bypass surgery.

“Our study reinforces the fact that when it comes to treating cardiovascular disease, there is a wide range of safe and effective treatments,” said Lookstein. Multicentre, randomised trials are necessary to support such promising results of the value of infrapopliteal drug-eluting stents in critical limb ischaemia treatments, he added.

In the USA, drug-eluting stents are FDA-approved for the coronary arteries but not for infrapopliteal arteries.

Patient selection is key for vertebroplasty – a minimally invasive treatment performed by interventional radiologists in individuals with painful osteoporotic vertebral compression fractures that fail to respond to conventional medical therapy – to be effective and successful, according to a study of more than 1,500 persons who were followed over seven years.

Additionally, collaboration between an interventional radiologist and other medical experts in treating a patient is imperative, say researchers at the Society of Interventional Radiology’s 35th Annual Scientific Meeting in Tampa, USA.

“Vertebroplasty puts lives and vertebrae back together,” said Giovanni C Anselmetti, interventional radiologist at the Institute for Cancer Research and Treatment in Turin, Italy. Before treatment, many osteoporotic patients are in constant pain and cannot manage everyday activities.

Anselmetti told Interventional News that patient selection is the key because vertebroplasty is indicated when conservative care fails and in painful vertebral fractures. “We need to demonstrate that patients have a vertebral fracture (we use MRI with T1, T2 and STIR sequences to do this), that this fracture is painful (we perform a clinical interview to do this) and that medical treatment does not work (This is ascertained when the patients is still in pain after one, three and five months after optimal medical therapy performed by experienced an rheumatologist, endocrinologist, etc). If we select these kind of patients, vertebroplasty is effective in more than 95% of treated patients,” he said.

Vertebroplasty stabilises collapsed vertebrae with the injection of medical-grade bone cement into the spine. The treatment provides pain relief and improves one’s quality of life—if given to appropriately selected candidates in whom conventional medical treatment has failed (such as analgesics or narcotic drugs that provide minimal or no pain release or doses that are intolerable), he further explained. “Our long-term follow-up confirmed this: pain relief and quality of life significantly improved with vertebroplasty,” said Anselmetti.

Osteoporosis, the most common type of bone disease, is characterised by low bone mass and structural deterioration of the bone, resulting in an increased susceptibility to fractures. “Vertebroplasty dramatically improves back pain within hours of the procedure, provides long-term pain relief and has a low complication rate, as demonstrated in multiple studies,” said Anselmetti.

Vertebroplasty provides pain relief from the complications of osteoporosis (vertebral fractures) but not the disease that caused it (osteoporosis), said Anselmetti. “For the best results, collaboration between physicians is mandatory. All osteoporotic patients need to be followed by an interventional radiologist, who determines which patients are appropriate candidates to receive vertebroplasty treatment, and an experienced medical expert (in this study, a rheumatologist) to ensure continued treatment for osteoporosis,” he said.

Anselmetti illustrated a typical case: an 80-year-old Italian woman, who was diagnosed last year with two painful osteoporotic vertebral collapses, underwent medical treatment for osteoporosis (with the drug teriparatide) and was still in pain when she was prescribed an external brace. After there was evidence of two new fractures (verified by MR imaging), she received vertebroplasty, experiencing “complete pain regression, no need for the brace and a dramatic Lazarus-like ability to perform daily activities,” he noted.

Researchers studied 2,251 osteoporotic patients (1,811 women; average age, 65) suffering from backpain for vertebral collapses (MRI confirmed) who underwent a clinical interview; their medical treatment, pain grade, quality of life and extent of vertebral fracture were reviewed. Vertebroplasty was performed in 1,542 patients (1,302 women; average age, 73) when optimal medical treatment (such as biphosphonates, teriparatide, analgesics and back brace) did not help relieve pain or improve quality of life for patients over a three-month period. After vertebroplasty, patients continued to receive medical treatment with a rheumatologist. Because interventional radiologists use high-quality, image-guiding systems (such as digital flat-panel fluoroscopy with built-in rotational image acquisition), treatment time is decreased, making for a safer procedure, added Anselmetti.

In 1,494 patients (96.9 per cent), the average pretreatment pain score on the 11-point visual analog scale was 8.2±1.8, and it dropped “significantly” to an average of 1.1±1.6 after vertebroplasty treatment, said Anselmetti. A patient’s ability to manage everyday life—such as washing, dressing or standing—was measured by the commonly used Oswestry Disability Questionnaire, which was completed by patients before and after vertebroplasty. The ODQ scores changed from an average of 68.7±7.6 per cent to 18.5±8.2 per cent. Long-term follow-up (average, 31.2 months) in 1,017 patients (857 women; average age, 72) showed the VAS significantly dropping from 7.9±1.5 to 1.3±1.7. Of the 757 patients wearing a back brace before vertebroplasty, 683 could stop wearing one after treatment.

Anselmetti said that additional studies need to be performed, such as a large randomised trial comparing conventional medical treatment to medical treatment plus vertebroplasty. In Europe, this is difficult, as patients with chronic back pain for vertebral osteoporotic fractures prefer to be treated by vertebroplasty—and not randomised into a medical treatment-only group. “Patients who are in so much pain ask if they can be considered for vertebroplasty treatment,” he said.

Excellent image quality and industry-leading dose efficiency to powerful clinical visualisation tools displayed

Building on innovative digital flat panel technology and one of the world’s most installed family of all digital interventional X-ray imaging systems, GE Healthcare, a $17 billion unit of General Electric Company, continues the innovation from excellent image quality and industry-leading dose efficiency to introduce new clinical visualisation tools – including Innova Vision and Innova TrackVision-. These tools will allow interventional radiologists to see more than ever before.

“This is an exciting time in Interventional Radiology,” says Hooman Hakami, President and CEO, Interventional Systems at GE Healthcare. “These advanced applications enable enhanced visualisation and streamlined workflow. This will allow interventional radiologists to focus more on their patients. The result is a more confident team of clinicians and a more efficient IR lab.”

Image-guided interventional care innovations at SIR:

Innova 4100IQ: The Innova 4100IQ is a comprehensive X-ray imaging solution that gives interventional radiologists the tools they need to take image-based diagnosis and minimally invasive therapy to a higher level. The system is now infused with advanced software applications that not only provide precise anatomical detail, but also help simplify and expedite even the most complex and challenging diagnostic and interventional procedures. It is well suited for a wide range of procedures including peripheral, oncological and neurological imaging.

– Innova with Subtracted 3D: Subtracted 3D quickly lets the user visualise vessels without having to remove surrounding bone, tissue and implanted devices and also lets the user easily visualise side-by-side non-subtracted 3D, subtracted 3D or 3D mask images to compare, merge, and analyse complementary images for more interventional information than ever before.

– Innova with Blended Roadmap: It superimposes any DSA or InnovaBreeze bolus image with fluoroscopy and streamlines workflow with easy to use controls right at the tableside. It also provides dedicated registration tools such as pixel shifting to quickly correct for patient movement and visualisation capabilities such as landscape and vessel visibility that can be separately adjusted during the procedure for improved vessel and anatomy visualisation. This excellent dose efficient system continues to potentially reduce dose and use of contrast media by using any previously acquired DSA or bolus image multiple times.

– InnovaIQ Tilt Table: Featuring Smart Tilt, variable-force positioning and fully motorised panning even when tilted, the InnovaIQ Tilt Table brings more flexibility and automation to IR procedures. It helps enhance angio acquisition modes such as multi-segment DSA, Innova Breeze and Instant Mapping. An auto-positioning tool provides repeatable clinical positioning for 2D and 3D acquisitions, and fast transitions from one complex position to another.

Clinicians also gain control of the entire system with fully integrated and highly intuitive tableside controls. This includes the ability to configure the system, modify imaging parameters and perform in-room interactive analysis functions tableside.

Innova Dose-Efficient X-ray Technology: GE Healthcare introduces innovative dose efficient technology, for its Interventional Radiology products. Powered by the innovative GE AutoEx control system, it automatically and continuously adapts to help keep image quality and patient dose at optimum levels. The AutoEx System can reduce patient dose by as much as 40% without compromising image quality and is one of the first new-to-market product features validated under GE’s healthymagination initiative, dedicated to improving the quality, access and cost of healthcare.

Innova systems use a flat-panel detector that provides the industry’s highest Detective Quantum Efficiency (DQE), a parameter internationally accepted as the best index of detector performance in the contrast- and dose-limited imaging done in actual clinical studies. High DQE enables better-quality images at the same dose, or the same-quality image at a lower dose.

In addition, AutoExposure Preference Settings let physicians personalize image quality and dose. InnovaSense patient contouring further extends dose efficiency, helping to minimise detector-to-patient distance for fast positioning, excellent image geometry, and less radiation exposure.

Innova Vision: Advanced application that allows physicians to perform interventions with confidence. It dynamically overlays 2D fluoroscopic images and 3D models from multiple modalities. It provides 3D imaging with excellent image quality – providing relevant information during complex procedures.

This fused roadmapping display enables the clinician to support localization and guidance of guidewires, catheters, coils and other devices by visualising them on a real-time 3D model.

Innova TrackVision: The Innova TrackVision application allows physicians to progress with more information and confidence, specifically for non-vascular, needle based interventional procedures. It provides needle trajectory planning and control right from the Innova Central tableside touchscreen, which is fully integrated into IR workflow for maximum ease of use.

Interventional Visualization: VolumeShare™ 4 multi-modality volume view software is an option for the multi-modality, image review Advantage Workstation™. VolumeShare 4 integrates 3D images from Innova® 3D, Innova CT as well as CT, MR, Pet and PET/CT datasets to enable a number of new interventional visualization functions that are targeted to image-guided interventional therapy. Processing, integration and image overlay are achieved with a single workstation, with a single, convenient user interface, helping to shorten procedure time and improving access to image-guided interventional care.

Veran ig4: Multi-modality navigation system that utilizes electromagnetic localization and image fusion to display an interventional instrument, such as a biopsy needle, an aspiration needle, or an ablation needle, on a computer monitor that also displays a CT-based model of the target organ(s). GE’s Innova imaging systems acquire computerized tomography (CT)-like patient images, which under the terms of the collaboration agreement signed with Veran Medical, can be exported to the Veran ig4 Navigation system in the same imaging suite, during the same interventional procedure. The Innova CT image will be displayed along with a virtual needle over the anatomy to be used for navigation during the procedure. The resulting displayed image will provide navigation information to help physicians insert biopsy needles, ablation (RF, cryotherapy, and microwave) probes and other devices through the skin more quickly and with greater target accuracy.

New interventional radiology tool could help women avoid myomectomy and hysterectomy.

A study of more than 100 patients shows that women can get lasting relief from uterine fibroid-related symptoms with MRgFUS—thus avoiding myomectomy, or hysterectomy, say researchers at the Society of Interventional Radiology’s 35th Annual Scientific Meeting in Tampa, USA.

Magnetic resonance-guided focused ultrasound (MRgFUS), a minimally invasive treatment, uses high-energy ultrasound waves to generate heat at a specific point to destroy uterine fibroid tissue and relieve symptoms.

“Our 119-patient study shows that magnetic resonance-guided focused ultrasound is highly effective and can provide lasting relief from uterine fibroid-related symptoms,” said Gina Hesley, Mayo Clinic in Rochester, USA. In the 12 months following MRgFUS treatment, 97% of the women reported improvement of their symptoms, with 90% of women rating their improvement as either considerable or excellent. “MRgFUS is newer than another interventional radiology fibroid treatment, uterine fibroid embolization, a widely available treatment that blocks blood flow to fibroid tumours. Our results with effectiveness of MRgFUS technology are promising and comparable with that of UFE, but its long-term effectiveness needs continued study,” said Hesley.

“Today, women have interventional radiology options that do not involve the use of a scalpel incision. Women should ask for a consult with an interventional radiologist who can determine from MR imaging whether they are candidates for either procedure,” she added.

MRgFUS is performed as an outpatient procedure; it uses high-intensity focused ultrasound waves— that can pass through skin, muscle, fat and other soft tissues—to ablate fibroid tissue. During treatment, the physician uses magnetic resonance imaging (MRI) to see inside the body to deliver the treatment directly to the fibroid. MRI scans identify the tissue in the body to treat and are used to plan each patient’s procedure.

MRI provides a three-dimensional view of the targeted tissue, allowing for precise focusing and delivery of the ultrasound energy. MRI also enables the physician to monitor tissue temperature in real-time to ensure adequate—but safe—heating of the target. Immediate imaging of the treated area following MRgFUS helps the physician determine the success of the treatment. The procedure was approved by the Food and Drug Administration for treating uterine fibroids in October 2004; however, it is still considered new, is not widely available and not all insurance carriers cover it.

In the nearly three-year study, 119 women completed MRgFUS treatment at the Mayo Clinic and were followed for 12 months using phone interviews to assess fibroid-related symptoms and symptomatic relief.

Of the 89 patients who were available for phone interviews at 12 months, 69 indicated they received from the following relief from symptoms: excellent (74%), considerable (16%), moderate (9%) and insignificant (1%). The rate of additional treatments needed post-MRgFUS was 8%, which is within values reported for myomectomy and uterine fibroid embolization, said Hesley.

The Mayo researchers will continue to study two-year and three-year results of symptom relief. They will also compare their current results with those reported for myomectomy and uterine fibroid embolization and investigate the efficacy of MRgFUS in treating other uterine conditions, such as adenomyosis, a condition in which tissue that normally lines the uterus also grows within the muscular walls of the uterus, said Hesley.

MDS Nordion has announced that TheraSphere, an innovative Yttrium-90 radioembolization treatment for hepatocellular carcinoma (HCC), commonly known as primary liver cancer, was the topic of several presentations at the 2010 Society of Interventional Radiology (SIR) 35th Annual Scientific Meeting.

One of the presentations was focused on an investigator initiated study led by Riad Salem, MD, interventional radiologist and professor of radiology, medicine and surgery at Northwestern University, Chicago, USA. Salem and colleagues assessed clinical outcomes using TheraSphere in 291 patients suffering from HCC. Robert Lewandowski, a co-author and an interventional radiologist at Northwestern Memorial Hospital, presented a comprehensive analysis of the findings.

“This study is one of the first to look at radioembolization treatment with a large cohort of patients at various stages of the clinical disease progression,” said Salem. “In our analysis, we were able to determine what particular patient type would benefit from this treatment. This study has provided significant data points that could support future studies of similar scope.”

Steve Hong, a radiologist at William Beaumont Hospital, Michigan, USA, presented a study addressing the deterioration in liver function following radioembolization treatment for HCC. The study concluded that while liver deterioration is a known complication of radioembolization, most liver deterioration appeared to occur due to underlying cirrhosis or further progression of the patient’s liver cancer.

“These physicians have tremendous clinical experience and insight with respect to TheraSphere and how it performs in patients suffering from HCC,” said Kevin Brooks, vice-president, Marketing, MDS Nordion. “The existing standard of care for HCC treatment is maturing, and the interventional radiology community recognises that new and less invasive therapeutic technologies, like TheraSphere, ultimately benefit patients.”

Uterine fibroid embolization, a minimally invasive interventional radiology procedure that blocks blood supply to treat painful uterine fibroids, has a comparable fertility rate to myomectomy, the surgical removal of uterine fibroids, for women who want to conceive, according to the first study on the subject released at the Society of Interventional Radiology’s 35th Annual Scientific Meeting in Tampa, USA.

“This study is significant because it shows comparable fertility rates between the two primary uterus sparing treatments widely available to treat fibroids: uterine fibroid embolization (UFE) and surgical myomectomy, which is considered the gold standard for symptomatic fibroids in women who wish to conceive,” said João Martins Pisco, an interventional radiologist at St. Louis Hospital in Lisbon, Portugal. “These results are surprising because other studies have favoured surgical myomectomy over UFE for women who want to conceive. In this study of 743 women, UFE had a fertility rate of 58.1%, which is comparable to surgical fibroid removal (myomectomy), which has a fertility rate of 57%,” noted Pisco.

“Our study proves that UFE not only allows women who were unable to conceive to become pregnant but also allows them to have normal pregnancies with similar complication rates as the general population in spite of being a high risk group,” he added. “In the future, UFE will probably be a first-line treatment option even for women who wish to conceive and are unable due to the presence of uterine fibroids,” he noted.

Uterine fibroids are benign tumours in the uterus that can cause prolonged, heavy menstrual bleeding that can be severe enough to cause anaemia or require transfusion, disabling pelvic pain and pressure, urinary frequency, pain during intercourse, miscarriage, interference with fertility and an abnormally large uterus resembling pregnancy.

An increasing number of women are delaying pregnancy until their late thirties, which is also the most likely time for fibroids to develop, said Pisco. There is conflicting evidence in the medical literature regarding the impact of fibroids on pregnancy; however, the risk and type of complication appear to be related to the size, number and location. Women may not know they have fibroids (asymptomatic) and undergo in vitro fertilisation treatments—rather than getting treatment for fibroids. “We want women to know that uterine fibroids may be a cause of infertility, that their treatment is mandatory and that UFE may be the only effective treatment for some women,” said Pisco.

The conventional treatment of uterine fibroids in patients who wish to become pregnant is myomectomy, which is surgical fibroid removal. This treatment is usually effective, particularly if the fibroids are in small number and of small or medium size. UFE, which has a lower complication rate than myomectomy, may be performed if a woman has many fibroids or large-sized fibroids and a gynaecologist cannot rule out a hysterectomy during myomectomy or if myomectomy is unsuccessful.

In the Portuguese study, most women opted for UFE as a fertility treatment after failure of myomectomy or in vitro fertilisation or because hysterectomy was the only suggested option. Of the 743 patients who received UFE treatment, 74 wanted to conceive and had been unable to do so. Of these 74 women, 43 or 58.1% (average age, 36.2) became pregnant; the time between UFE and conception ranged from two to 22 months. At this time, there have been 36 completed pregnancies, resulting in 30 births (83.3%); seven women are still pregnant.

“Most of the pregnancies after uterine fibroid embolization had good outcomes with few complications. The complication rate of the pregnancies was expected to be higher than the general population because these were high-risk patients who had already undergone fertility treatments and were unable to conceive,” said Pisco. “However, the percentage of the spontaneous abortions (11.1 percent), preterm delivery (10.0 percent) and low birth weight (13.3 percent) was the same as the general population,” he stated.

This was a small retrospective study based on patients being treated for fibroids by UFE in a single institution, said Pisco. He said that larger, multicentred, randomised prospective studies are needed comparing UFE and myomectomy.

An important interventional radiology advancement—the use of a new cerebral protection device in combination with FDA-approved carotid stents in high-surgical-risk patients—provides a minimally invasive, safe and effective way to prevent stroke from occurring during treatment to clear blocked carotid arteries, according to research released at the Society of Interventional Radiology’s 35th Annual Scientific Meeting in Tampa, USA.

“Interventional radiologists are at the forefront in advancing stroke care. Using a new FDA-approved cerebral protection device during carotid artery stenting effectively reduces and captures particles released during the stenting procedure in order to prevent this debris from travelling to the brain where it has the potential to cause a stroke,” noted Barry T Katzen, interventional radiologist and medical director of Baptist Cardiac and Vascular Institute in Miami,USA.

“The Mo.Ma device, which uses balloons that are inflated and act like endovascular surgical clamps to protect the brain during the procedure, provides a treatment option for patients who may not be healthy enough to undergo surgery, for example, those with severe heart or lung disease or those who have had neck operations or radiation for neck tumours.

The Mo.Ma device provides an important alternative to surgery for stroke prevention,” he added. In the study, 262 patients were enrolled between September 2007 and February 2009 at 25 investigational sites, 20 were in the USA and five were in European Union. At 30 days, the major adverse cardiac and cerebrovascular event rate (MACCE) of stroke, death and heart attack was 2.7%, with the major stroke rate through 30 days at less than 1%—compared to a 13% MACCE rate typically derived from previous carotid stenting trials. A low MACCE rate demonstrates the safety and effectiveness of the device in clinical use, said Katzen. “Interventional radiologists are critical members of stroke teams in hospitals—working with emergency room physicians and neurologists in combating stroke, the third leading cause of death in the United States,” said Katzen. “This device and interventional radiology treatment are added tools to improve stroke prevention,” said Katzen. While there are “debris catcher” and other balloon occlusion devices currently available, the Mo.Ma device refines carotid stenting treatment.

“Interventional radiologists are leaders in participating in clinical trials using minimally invasive new technologies. The data collected in the ARMOUR trial have led to FDA clearance, thus allowing broader physician access to the Mo.Ma proximal cerebral protection device in the treatment of patients with carotid artery disease,” noted Katzen.

In the ARMOUR trial, patients with carotid artery disease and who were not suitable candidates for carotid artery surgery were considered for carotid artery stenting accompanied by the use of the Mo.Ma device. Patients who provided written informed consent and met inclusion/exclusion criteria were enrolled in the ARMOUR trial, a pivotal, prospective, multicenter, nonrandomised trial to evaluate the safety and effectiveness of the device. The average age of the patients was 75 years, and nearly 29% were octogenarians. Nearly 67% were men. Patients were assessed at 30 days to measure the continued success of the procedure and any ill effects that may have occurred.

Following Food and Drug Administration review, Invatec received clearance to market the Mo.Ma device for use during carotid artery stenting in the United States. The Mo.Ma device establishes full-time cerebral protection during the carotid stenting procedure prior to crossing the internal carotid artery lesion. It is comprised of two small balloons that are inflated in the external carotid artery and the common carotid artery to suspend blood flow during the stenting procedure. The balloons act like endovascular surgical clamps, protecting the brain during the procedure. The suspended blood is then aspirated along with any particles to complete the procedure safely.

The new NavAlign femoral delivery system, to be launched today in booth #406 at the SIR Annual Scientific Meeting, complements the already available jugular access version

Physicians placing inferior vena cava (IVC) filters to prevent life-threatening pulmonary emboli now have access to the latest iteration of Cook Medical’s advanced NavAlign delivery system, a deployment system designed to minimise the risk of vessel trauma and streamline filter placement. The new NavAlign femoral delivery system, to be launched today in booth #406 at the SIR Annual Scientific Meeting, complements the already available jugular access version.

NavAlign is the landmark product of Cook’s new venous programme, an integrated line of products engineered to treat the spectrum of venous disease — from superficial venous insufficiency to deep system conditions like deep vein thrombosis (DVT).

“Chronic venous disease affects up to one-third of the population of all developed countries, so it is vital to provide dedicated treatment options addressing this growing patient population,” said Rob Lyles, vice president and global leader of the peripheral intervention division at Cook Medical. “We’ve introduced specialised access tools that have gained initial acceptance, and today marks a milestone for Cook both in advancing treatment using IVC filters and tapping the potential of the emerging venous market as a whole.”

NavAlign, available for Cook Celect and Günther Tulip filters, incorporates a haemostasis valve to minimise blood loss. With an accompanying multipurpose dilator, radiopaque sizing marker bands and flushing sideports designed to decrease fluoroscopy time and contrast medium amounts, the NavAlign system is ideal for physicians using image guidance to place IVC filters to help protect patients from DVT and pulmonary embolism (PE), a life-threatening condition that can kill one out of three individuals if left untreated.

For more information and to see live demonstrations of NavAlign or the other interventional radiology and peripheral intervention products available from Cook Medical, visit booth #406 at the 2010 SIR Annual Scientific Meeting.

With the International Carotid Stenting Study (ICSS) results giving carotid endarterectomy a definite thumbs-up and hammering a few nails in the coffin for carotid artery stenting, the results of the purist trial CREST have long been awaited for either confirmation, or disagreement of results.

For long, the question has been: Will the CREST trial results be the last nail in the coffin for carotid artery stenting, or will it be what interventional radiologists’ have been hoping for, a shot in the arm for stenting?

The CREST(Carotid revascularisation endarterectomy versus stenting)trial results were announced in late February at the American Stroke Association International Stroke Conference 2010.

Both procedures were shown to be equally safe and effective for the treatment of carotid atherosclerosis and the prevention of stroke, myocardial infarction, and death.

Interventional News asked two prominent interventionists to comment on the CREST results:

James F Benenati, Baptist Cardiac & Vascular Institute and SIR president elect said:

“The CREST results demonstrate that carotid artery stenting is a good and safe alternative to carotid endarterectomy giving patients two options for therapy. Which option a patient chooses should depend on their risk factors and the experience of the operators doing the procedures. While there is a higher minor stroke risk with stenting, the overall complication rates are similar for the two procedures. The IR community has long awaited these results and is enthusiastic to move forward with carotid artery stenting in the proper patients.”

Tony Nicholson,consultant vascular and interventional radiologist at the Leeds Teaching Hospitals NHS Trust said:

“The publication of CREST is timely coming so close to the publication of ICSS. The results of the two studies reflect slightly different methodologies and emphasis. They also remind us that it is rare for any one randomised, controlled trial to give the whole answer and there will always be methodological flaws and differences in interpretation especially where there is equipoise and small differences in results. Both CREST and ICSS are excellent studies but we still need more of their kind in order to eventually meta-analyse the results. It is probably true to say that until we have a robust meta-analysis, we should all continue to work cooperatively in this field, keeping accurate data and entering patients into the best trials available”

In the trial 2,502 patients with either symptomatic (n=1,321) or asymptomatic (n=1.181) carotid stenosis were randomised to endarterectomy or carotid stenting at 117 centres in the United States and Canada over a nine-year period. Patients were an average age of 69 years and were followed for up to four years (median 2.5).

On the composite primary endpoint of any stroke, myocardial infarction or death during the periprocedural period or ipsilateral stroke on follow-up, stenting was associated with a 7.2% rate of these events vs. 6.8% with surgery, a non-significant difference.

However, it was found that, at 30 days, the rate of stroke was significantly higher with stenting, at 4.1% vs. 2.3% with surgery. There was no difference with major stroke, though, at less than 1% in both groups. Conversely, myocardial infarction was higher with carotid endarterectomy, at 2.3% vs. 1.1% with stenting, a statistically significant difference.

Rates of ipsilateral stroke during a mean follow-up of 2.5 years were equal between groups, at 2.0% for stenting and 2.4% with surgery.

Wesley Moore, Los Angeles, United States, who was co-principal investigator on CREST, said, “When considering the combined endpoints of death, stroke, and myocardial infarction, carotid endarterectomy and carotid stent/angioplasty have similar results. However, when death and stroke are considered alone, there are almost twice as many events with carotid stenting/angioplasty as there are with carotid endarterectomy. Nonetheless, the complication rates for both procedures are the lowest reported in the literature to date and suggest that both are safe and effective in the short term of the study to date.”

The age of the patient made a difference, it was found. Younger patients did better with stents and older patients did better with surgery. For patients 69 years and younger, stenting results were superior to surgical results; the younger the patient, the larger the stenting benefit. Conversely, for patients older than 70, surgical results were slightly better than stenting; the older the patient, the larger the surgery benefit.

There were twice as many myocardial infarctions in the surgical group (2.3% compared to 1.1% in the stenting group). There were also more minor strokes (non-disabling strokes that largely resolved) in the stenting group (2.7% versus 1.5% for the surgical group).

The results of CREST have been keenly anticipated since the presentation in 2009 of the ICSS (International carotid stenting study) results, which showed disappointing outcomes with stenting. Martin Brown, London, United Kingdom, who presented the ICSS data at the European Stroke Conference in 2009 has responded to the CREST results. He said, “It is difficult to compare the results of ICSS and CREST directly because ICSS studied only patients in whom the carotid stenosis was recently symptomatic, whereas 47% of patients in CREST were asymptomatic. The CREST presentation did not provide the results separately for the asymptomatic and symptomatic patients. In the combined results they presented, the complication rate of stenting was a little lower in CREST than it was in ICSS, but this is likely to reflect the fact that half the patients had asymptomatic stenosis, which we would expect to have a lower risk of stenting as well as a lower risk of endarterectomy. Otherwise the results look very similar to ICSS in that in CREST there were significantly more procedural strokes in the stenting arm than in the endarterectomy arm (4.1% vs. 2.3%, which was statistically significant). There were more myocardial infarctions in both arms of the trial in CREST than ICSS, but CREST had a different protocol for ascertaining myocardial infarctions, which is likely to account for the difference. I will await the publication of the results of individual endpoints in the symptomatic patients in CREST with interest. In the meantime, I do not believe the results of CREST should alter the conclusion that endarterectomy remains the treatment of choice for symptomatic patients.”

Moore will present the CREST results for the first time to a vascular and endovascular audience at the 32nd Charing Cross International Symposium in London, United Kingdom in April 2010. Of the upcoming presentation, Moore said, “The CREST results are at variance with the European trials and will make for an interesting discussion.”

This year’s meeting theme is “IR Innovation”— one that celebrates the remarkable inventiveness of interventional radiologists.

More than 5,000 physicians, scientists and allied health professionals are expected to attend this premier IR event. Hot topic main sessions include a look at practicing interventional radiology in extreme situations (wars, pandemics and natural catastrophes); IR frontiers (molecular medicine and nanotechnology); vertebral augmentation (past, present and future treatments); and future interventional oncology advances. A new categorical course will examine the most controversial interventional radiology–related studies of the past year—including critical review of the latest advances along with pro and con arguments. Topics that will be explored include vertebroplasty, stroke and yttrium-90 cancer treatments.

Central to the meeting’s theme will be the presentation of painstakingly researched data on how prolific IRs have been as inventors and the impact their innovations have had in advancing patient care and building the specialty. This research—conducted during an exhaustive search of patent filings and applications at the PCT (Patent Cooperation Treaty) and the US Patent and Trademark Office—will be honoured with a special “Hall of Innovation.”

Some of the exciting topics that will be featured at this year’s press conferences include minimally invasive advances coming for liver, breast, soft tissue, prostate, lung and pancreatic cancers; vertebroplasty for osteoporotic and non-osteoporotic patients; uterine fibroid embolization and pregnancy; getting to the heart of stroke with carotid stenting; another surprising look at Framingham risk scores; and stem cell therapy and stenting advances for peripheral arterial disease.

Plenary sessions include

On March 14, Matthew S. Johnson, professor of radiology and surgery, Indiana University School of Medicine, Indianapolis, leads the discussion on “Frontiers of IR,” highlighting current cutting-edge news from animal research to clinical studies to innovative practice initiatives (including molecular medicine, nanotechnology, stenting jugular veins for multiple sclerosis). Kieran J Murphy, vice chair and deputy chief of medical imaging at the University of Toronto in Ontario, Canada, coordinates “IR in Extremis,” a look at how IRs struggle through war, poverty, pandemic and natural disaster to treat patients.

On March 15, Michael C Soulen, professor of radiology and surgery, University of Pennsylvania School of Medicine in Philadelphia, addresses “IR Generations” as the 2010 Charles T Dotter lecturer. This lecture honour, supported by SIR Foundation, acknowledges an interventional radiologist’s extraordinary contributions to the field, dedicated service to SIR and distinguished career achievements in interventional radiology. Jeff H Geschwind, director of vascular and interventional radiology, director of the Interventional Radiology Center at Johns Hopkins Hospital, Baltimore, USA, and professor of radiology, surgery and oncology at Johns Hopkins University School of Medicine, leads the discussion on “Interventional Oncology in the 2010s: Where Are We Headed?”

On March 16, Julio Palmaz, Ashbel Smith Tenured Professor at the University of Texas Health Science Center in San Antonio who holds 40 issued patents and conceived and developed the first clinically successful balloon expandable vascular stent (called one of the “ten patents that changed the world”), will receive the SIR Foundation’s 2010 Leaders in Innovation Award. He will also coordinate the “Innovation in IR” plenary session. SIR Gold Medalists—John D Fulco, the past chief of staff of the Ellis Health System in Schenectady, and past president of the Medical Society of the County of Schenectady; Irvin F. Hawkins, professor of radiology and surgery at the University of Florida College of Medicine in Gainesville; and David C Levin, professor and chair emeritus of the department of radiology at Jefferson Medical College and Thomas Jefferson University Hospital in Philadelphia – will be honoured.

New England Journal of Medicine publishes first study to show minimally invasive interventional radiology approach for end-stage kidney disease patients is “superior” in treating blocked access

A randomised multicentre study of 190 patients at 13 medical centres shows—for the first time—the “superior” benefit of stent grafts over balloon angioplasty for maintaining the function of dialysis access grafts in kidney failure patients who undergo dialysis. Until now, no other therapy has proven more effective than angioplasty. At six months, the stent grafts allowed dialysis patients to continue life-saving treatment with significantly fewer interruptions and invasive procedures, according to a study published in the New England Journal of Medicine (N Engl J Med 2010;362:494-503.). Haemodialysis is the leading treatment for more than 340,000 patients in the United States with end-stage renal disease (ESRD), or kidney failure.

Trial investigators wrote in the NEJM that the leading cause of failure of a prosthetic arteriovenous haemodialysis-access graft is venous anastomotic stenosis. Balloon angioplasty, the first-line therapy, has a tendency to lead to subsequent recoil and restenosis, but, no other therapies have yet proved to be more effective. This study was designed to compare conventional balloon angioplasty with an expanded polytetrafluoroethylene endovascular

stent graft for revision of venous anastomotic stenosis in failing haemodialysis grafts.

“Stent grafts are a game changer for dialysis patients, especially for those who suffer due to the repeated need for invasive procedures to maintain their ability to get dialysis,” said Ziv J Haskal, vice chair of Strategic Development, and chief of Vascular and Interventional Radiology at the University of Maryland Medical Center in Maryland, USA.

“This study—the first large prospective controlled study of its kind—shows that this novel therapy, stent grafts, provide clear improvement over balloon angioplasty by prolonging the function of a patient’s bypass without surgery—helping individuals avoid additional invasive procedures and time in the hospital,” noted Haskal, who is also professor of Radiology and Surgery at the University of Maryland School of Medicine. “Stent grafts overwhelmingly performed better than balloon angioplasty for maintaining access in dialysis patients, providing “superior” patency and “freedom from repeat interventions,” added the lead investigator and author of Stent Graft Versus Balloon Angioplasty for Dialysis Access Graft Failure. “What we have done, is arguably supersede the results of surgery by improving the flow dynamics beyond those achievable with an operation.”

Thirteen participating sites—including academic, community-based, inpatient and freestanding outpatient dialysis centres—enrolled 190 patients (69 men, 121 women) with failing arteriovenous (AV) grafts in this study, said Haskal. Ninety-seven patients received stent grafts, with 93 undergoing balloon angioplasty (percutaneous transluminal angioplasty or PTA). There were no significant differences between graft and PTA groups with respect to demographics or relevant medical history. Nearly 51% of dialysis accesses treated with stent grafts remained open at six months, as compared to just 23% of those treated with balloon angioplasties. Treating physicians had a nearly 94% success rate at implanting the stent grafts. There were no differences in adverse events between the two approaches.

Results from the study led investigators to conclude that “percutaneous revision of venous anastomotic stenosis in patients with a prosthetic haemodialysis graft was improved with the use of a stent graft, which appears to provide longer-term and superior patency and freedom from repeat interventions than standard balloon angioplasty.”

Since then, the NEJM has commissioned an editorial commentary on the paper by Drs Kerlan and Laberge, from University of California, San Francisco, USA.

“Interventional radiologists work to keep access to the circulatory system open to ensure that patients with end-stage renal disease can continue to receive regular life-saving dialysis,” noted Society of Interventional Radiology President Brian F Stainken, who represents a national organisation of nearly 4,500 doctors, scientists and allied health professionals dedicated to improving health care through minimally invasive treatments. “This study is another example of the way in which interventional radiologists pioneer advances to improve health care for patients—in this case, specifically for kidney failure patients,” added Stainken, an interventional radiologist who is also president of the Imaging Network of Rhode Island and chair of the diagnostic imaging department at Roger Williams Medical Center in Rhode Island, USA.

In chronic kidney or end-stage renal disease treatment, haemodialysis is needed to maintain fluid, electrolyte and acid–base balance. Before dialysis can begin, patients often have a vascular access graft surgically placed in the arm to provide a high-flow site. This prosthetic fistula works by connecting a patient’s vein with an artery in their forearm, allowing high flow of blood from the artery into the vein.

Over time, the accesses occlude due to buildup of scar tissue. Failing or occluded dialysis access grafts causes considerable morbidity, discomfort and inconvenience for dialysis patients due to the need for invasive procedures to re-establish access flow or to graft abandonment and reoperation. When failure occurs, per National Kidney Foundation Guidelines, an interventional radiologist normally performs a balloon angioplasty to reopen the fistula and regain access for dialysis.

The 4th Annual Global Embolization Symposium and Technologies (GEST) conference, the original and largest embolization meeting, will take place this May 6 – 9, 2010 in San Francisco, California at the Westin Market Street Hotel.

 Held in partnership with the Society of Interventional Radiology (SIR), this is GEST’s fourth edition and the first to be held in the United States.

“As the leading innovative and comprehensive forum for embolization science and education, we are looking forward to bringing GEST to San Francisco, a city known internationally for its physical beauty, diversity and cultural resources and conference facilities,” said Ziv Haskal, one of the three co-founders of GEST. “This year’s event will once again feature a large international expert faculty, as well as attendees from all corners of the world, including many from the Eastern Hemisphere. Their participation is an integral part of delivering the global and unique GEST experience.”

The three Directors of GEST, Drs. Jafar Golzarian, Marc Sapoval and Ziv Haskal, founded the meeting with the mission of bringing practitioners the highest level of scientific and technical education on embolization, including new materials and devices, results, relevance for patient care and imaging. Participants will also have the opportunity to fine-tune existing skills and expertise in these areas in the most innovative and dynamic method possible.

Covering all disciplines of embolization, GEST 2010 will build upon the success of the past three years’ events, merging signature live demonstrations, Master Classes, Hands-On attendee events, in-depth technical sessions, evidence-based reviews, satellite symposia, research presentations and case-based teaching.

About GEST

The GEST Meeting is the original and largest embolization meeting and the only event to focus on a truly global and unique educational experience. It delivers total educational and professional know-how, by merging signature live demonstrations, Master Classes, Hands-On attendee events, in-depth technical sessions, evidence-based reviews, research presentations, and case-based teaching. After three successful meetings in Europe, including Paris and Barcelona, which drew thousands of total attendees from over 70 different countries, the meeting is coming to San Francisco from May 6 – 9, 2010.

For more information about GEST, including registration information and a preliminary scientific program, please visit www.gestweb.org or contact [email protected].

Iraqi Ministry of Health orders diagnostic imaging equipment worth around $70 million.

Siemens Healthcare will supply state-of-the-art diagnostics imaging equipment to all Ministry of Health hospitals (around 100) across Iraq. The recently signed contract has a value of around $70 million and is the biggest single order contract to be awarded to Siemens Healthcare in the Middle East. The products, which include magnetic resonance imaging and computed tomography equipment, mobile x-rays and mammography systems, help to increase diagnostic confidence, allowing for earlier detection of diseases. The equipment will be fully serviced over a period of five years.

The Minister of Health, Iraq, His Excellency Ali Saleh Al Hasnawi, comments, “We are excited to  be working closely with Siemens to offer this broad range of diagnostic services to all Ministry hospitals across Iraq. We have been a regular customer of Siemens for more than 30 years and are confident of the quality of their products, innovative solutions and excellent service history.”

“We are very proud to announce this agreement as it means we are playing an active role in the helping rebuild healthcare services in Iraq,” said Maurice Faber, Vice President Siemens Healthcare Sector Middle East. “One major result of this contract will be improved healthcare for all Iraqi people, and advanced breast cancer screening facilities for women in Iraq,” said Faber.