The trial’s results were published in JACC: Cardiovascular Interventions and show no intracranial haemorrhage and no death among massive pulmonary embolism patients.

EKOS Corporation, a BTG International group company, announced the publication of results of the SEATTLE II trial in the JACC: Cardiovascular Interventions. The study concluded that treatment with ultrasound-facilitated catheter-directed low-dose thrombolysis for acute pulmonary embolism improves right heart function, reduces blood clot size, and decreases pulmonary hypertension, in patients with intermediate to high risk pulmonary embolism. Importantly, no patient experienced intracranial haemorrhage, a serious adverse experience related to full-dose thrombolysis treatment.

The SEATTLE II study was a prospective, single-arm, multicentre trial designed to evaluate the safety and effectiveness of ultrasound-facilitated catheter-directed low-dose thrombolysis, using the Ekos EkoSonic Endovascular System. One hundred and fifty patients diagnosed as acute massive (n=31) or submassive (n=119) pulmonary embolism were enrolled. Patients received low dose (24mg) of tPA (thrombolytic) for 24 hours with a unilateral catheter or for 12 hours with bilateral catheters. The size of the right heart measured as RV/LV ratio significantly decreased from 1.55 to 1.13 (p<0.0001) by 48 hours after start of treatment.

For patients with severe pulmonary embolism, the mortality rate is nearly one third. In the SEATTLE II study, 31 patients presented to the emergency room with massive pulmonary embolism, syncope and hypotension. All 31 survived the 30-day follow up period. Of 150 patients in the study, one death was directly attributed to pulmonary embolism.

There were no intracranial haemorrhages and no fatal bleeding events. Major bleeds occurred in 15 patients and were comprised of one severe bleed and 16 moderate bleeds. Six of the major bleeds occurred in patients with co-morbidities known to be associated with an increased risk of bleeding during thrombolytic therapy.

“The SEATTLE II findings establish a new rationale for considering ultrasound-facilitated catheter-directed low-dose thrombolysis in both massive and submassive PE,” said Gregory Piazza, assistant professor of Medicine, Harvard Medical School, staff physician, Cardiovascular Division, Brigham and Woman’s Hospital, and principal investigator for SEATTLE II. “Without any intracranial haemorrhage and using a much reduced lytic dose, a substantial and clinically meaningful reduction of the RV/LV ratio was achieved.”

“The SEATTLE II and ULTIMA trials add to the body of evidence showing treatment with the EkoSonic Endovascular System improves the standard of care for patients with acute pulmonary embolism,” said Matt Stupfel, general manager of EKOS Corporation. “The only endovascular device cleared by the FDA for the treatment of pulmonary embolism, EkoSonic represents a potential game-changer in the treatment of high-risk pulmonary embolism patients. EKOS ultrasonic waves greatly accelerate lytic dispersion by driving the drug deeper into the clot and unwinding fibrin to expose plasminogen receptor sites.”

The ULTIMA trial, published January 2014 in Circulation, demonstrated that EKOS treatment was clinically superior to anticoagulation with heparin alone in reversing right ventricular enlargement at 24 hours, without an increase in bleeding complications. EKOS is launching the next study, OPTALYSE PE, to better understand the optimal dose of thrombolytic and duration of its treatment.

The Society of Interventional Radiology (SIR) is accepting scientific abstracts covering all areas of vascular and nonvascular interventional radiology for its 41st Annual Scientific Meeting, which will be held 2–7 April, 2016, in Vancouver, British Columbia, Canada. Online scientific abstract submission is open until 6 October.

Practicing experts, early career professionals, research scientists, clinical associates, trainees and medical students are invited to submit scientific abstracts for oral or poster presentation by 6 October. Researchers will have the opportunity to advance the field of image-guided interventions by sharing their basic science results, device and procedure innovations and clinical outcomes research at SIR 2016.

All selected scientific abstracts will be published in SIR’s flagship publication, the Journal of Vascular and Interventional Radiology, and on its website. Selected abstracts may be designated as “distinguished”, “featured” or “abstract of the year”.

Research awards to support travel are available through SIR Foundation for medical students, residents and fellows whose abstracts are accepted for oral presentation at SIR 2016. SIR’s International Scholarship program enables physicians (who are within 10 years of completion of training and who are practicing outside North America) an opportunity to train and learn at the meeting. SIR also offers two SIR 2016 scholarships for interventional radiologists-in-training: the SIR Medical Student Scholarship and SIR Resident-in-Training Scholarship.

For more information, please visit www.SIRmeeting.org.

GE Healthcare’s low dose computed tomography lung cancer screening option is the first to be cleared by the US FDA. Early detection with low dose CT can improve prognosis and treatment and reduce mortality rates for patients with a high risk of lung cancer.

Both the USA Preventative Services Task Force (USPSTF) and the Centers for Medicare and Medicaid Services (CMS) recommend the use of low dose CT lung cancer screening for high-risk individuals. Additionally, Medicare has approved insurance reimbursement for its beneficiaries who are eligible for the use of low dose CT lung cancer screening in high-risk patients.Early detection from an annual lung cancer screening with low dose CT in high-risk persons can prevent a substantial number of lung cancer related deaths, a press release from the company states.

“Bringing low dose CT screening to patients at a high risk for lung cancer will reduce death from the most deadly cancer worldwide,” said Ella Kazerooni, chair of committee on lung cancer screening, American College of Radiology. “Performing low dose CT with attention to high image quality at the lowest radiation exposure to detect early cancer is at the core of a successful screening programme, and requires collaboration with imaging partners to bring technology to bear for this purpose. The FDA’s clearance of these CT scanners for this purpose illustrates that commitment.”

Physicians using low dose CT for lung cancer screening will now have access to the benefits from a screening indication, including GE Healthcare’s new low-dose screening reference protocols. These new protocols are tailored to the CT system, patient size, and the most current recommendations from a wide range of professional medical and governmental organisations. Now, qualified GE Healthcare CT scanners can be confidently used by physicians within their FDA cleared indications for use, delivering low dose, short scan times, and clear and sharp images for the detection of small lung nodules. These nodules are critical in identifying lung cancer at its earliest stages when it is the most treatable and curable.

The landmark National Lung Screening Trial (NLST) was conducted at 33 medical institutions with over 53,000 older, otherwise healthy patients at high-risk due to smoking history. Half of the participants were screened using low dose CT, the other half were screened using chest X-ray. The trial demonstrated that the use of low dose CT screening decisively reduced the mortality rate from lung cancer by 20% compared to use of chest X-ray. The NLST also revealed a significant 6.7% reduction in the rate of death from any cause using low dose CT screening.

All new 64-slice and greater CT scanners, and virtually all of the 16-slice CT scanners that GE Healthcare sells are qualified systems and will include the screening option. The solution that GE Healthcare developed is also available to thousands of qualified GE scanners currently in use, increasing access to the quality scanners that satisfy both patient and physician needs. The new protocols are able to utilise GE Healthcare’s industry-leading technologies such as ASiRTM, ASiR-VTM and VeoTM that are designed to reduce image noise, which is undesirable for physicians looking for small nodules.

In the USA, lung cancer is the third most common cancer and the leading cause of cancer deaths; it kills almost twice as many women as breast cancer and three times as many men as prostate cancer. Survival rates from lung cancer are highly correlated to its initial stage at the time of first diagnosis. The overall five year survival rate for lung cancer is among the lowest (17%) of all types of cancer but is significantly higher when the cancer is diagnosed at an early stage (54%). However, currently only 155 of lung cancer cases are diagnosed at such an early stage. The use of low dose CT lung cancer screening increases this percentage of early stage detection, providing patients a much better prognosis.

The procedures have been performed by Sandeep Bagla, interventional radiologist, using the Magellan Robotic System. Bagla is one of the world leaders in the development of prostate artery embolization and is at the forefront of applying the Magellan Robotic System to this expanding procedure.

“We are excited about our clinical experiences with the Magellan Robotic System for prostatic artery embolization,” said Bagla, “Prostate artery embolization is a highly complex procedure that demands precision and control, key elements which are enhanced through robotics. We have completed 30 procedures thus far with the Magellan Robotic System and are delighted with the results we are seeing. We are highly confident in our ability to navigate through tortuous anatomy, our patients are very open to the approach and personally, I am drawn to the ability to reduce my procedural radiation exposure.”

Prostate artery embolization is a novel therapy in which the size of the prostate is reduced by a less invasive catheter-based approach that works to reduce blood flow to the main arteries that feed the prostate. Successfully performed prostatic artery embolization can reduce the prostate gland size and eliminate the symptoms associated with benign prostatic hyperplasia. Currently a patient must choose between long-term medical therapy or highly invasive surgical options that may often result in complications such as pain, bleeding, incontinence or impotence.

The Magellan Robotic System is designed to offer procedural predictability, control, and catheter stability to physicians as they remotely navigate the robotic catheter through the vasculature. Magellan’s remote workstation allows physicians to navigate through the vasculature while seated away from the radiation field, potentially reducing physicians’ radiation exposure and procedural fatigue.

InspireMD has announced that it has entered into a partnership with Penumbra to distribute its carotid CGuard EPS through their direct commercialisation team.

InspireMD has aggressively been pursuing a strategy in treating carotid artery disease and other neurovascular applications for its proprietary MicroNet technology.  Clinical trials of the CGuard system, including the recent CARENET and PARADIGM studies, have continued to support the benefits of the MicroNet enhanced CGuard system resulting in increased commercial adoption throughout the European market.

Penumbra has a direct and distributor sales organisation in all markets where the CGuard system is commercially available. Penumbra’s neurovascular product portfolio includes medical devices for ischemic stroke and brain aneurysms, as well as peripheral vascular products that include products for embolization and thrombectomy.  Penumbra has approximately 1,000 global employees with direct sales operations in North America, Europe, and Australia.  Penumbra sells through distributors in Asia and select other international markets.

CGuard EPS is CE mark approved. CGuard EPS, however, is not approved for sales in the US by the US FDA at this time.

Two recently published papers in the Journal of Vascular and Interventional Radiology (JVIR) reveal that patient materials in interventional radiology available online are way above the understanding of most patients. Both studies were carried out from the perspective of American patients and the investigators are urging hospitals and interventional radiologists to pay more attention to health literacy.

Referring to these studies, Ziv Haskal, editor-in-chief of JVIR, Charlottesville, USA, wrote in his editorial, “Consider this a call to arms as over 100 million users navigate the Web for healthcare information.”

One of the studies (Sadigh et al) set out to assess the readability of online education materials offered by hospitals describing commonly performed interventional radiology procedures. The investigators assessed online patient education materials from over 400 hospitals selected from the Medicare Hospital Compare database. They found that 76% of the hospitals presumed to offer interventional radiology services offered online patient education material for one or more of the eight service lines.

They assessed patient online education materials about uterine artery embolization for fibroid tumours, liver cancer embolization, varicose vein treatment, central venous access, inferior vena cava filter placement, nephrostomy tube insertion, gastrostomy tube placement, and vertebral augmentation using six validated readability scoring systems.

The authors reported that the average readability scores corresponding to grade varied between the ninth- and 12th-grade levels. All were higher than the recommended seventh-grade level (p<0.05) except for nephrostomy and gastrostomy tube placement. Average Flesch-Kincaid Reading Ease (that are readability tests designed to indicate how difficult a reading passage in English is to understand) scores corresponded with “fairly difficult” to “difficult” readability for all service lines except inferior vena cava filter and gastrostomy tube placement, which corresponded with standard readability.

A majority of hospitals offering interventional radiology services provide at least some online patient education material. Most, however, are written significantly above the reading comprehension level of most Americans, the authors conclude.

Another study (McEnteggart et al) set out to assess the readability of online patient education materials related to common diseases treated by and procedures performed by interventional radiology.

The investigators selected online patient education materials from the following websites due to their average Google search return: Society of Interventional Radiology (SIR), Cardiovascular and Interventional Radiological Society of Europe (CIRSE), National Library of Medicine, RadiologyInfo, Mayo Clinic, WebMD, and Wikipedia.

The interventional radiology content was assessed for the following procedures: peripheral arterial disease, central venous catheter, varicocoele, uterine artery embolization, vertebroplasty, transjugular intrahepatic portosystemic shunt, and deep vein thrombosis. The investigators analysed data using general mixed modelling and used a variety of common algorithms to estimate and compare readability levels.

They found that on average, online sources that required beyond high school grade-level readability were Wikipedia, SIR and RadiologyInfo; sources that required high school grade-level readability were CIRSE, Mayo Clinic, WebMD, and National Library of Medicine.

“On average, online patient education materials pertaining to uterine artery embolization, vertebroplasty, varicocele, and peripheral arterial disease required the highest level of readability,” the authors reported in JVIR.

The authors concluded that the materials assessed were “written above the recommended sixth-grade reading level and the health literacy level of the average American adult” and that “many patients may not have the ability to read and understand health information related to interventional radiology procedures.”

The American Medical Association (AMA) Current Procedure Terminology (CPT) Editorial Panel has established a new AMA CPT code specifically for transcervical uterine fibroid ablation with ultrasound guidance. Gynesonics applied for the new code, which was presented to the Editorial Panel in February.

CPT codes are used by medical practitioners including physicians, hospitals, and other healthcare providers, to report healthcare services to insurers for the purpose of reimbursement. This standardised nationwide system of identification provides a uniform language for reporting medical services.

The code has the following descriptor: Transcervical uterine fibroid(s) ablation with ultrasound guidance, radiofrequency. The announcement was posted and made available on the AMA website. The final code number will be released at a future date and will become effective on 1 January 2016.

The Sonata system from Gynesonics provides a uterus preserving, incision-free treatment option to women suffering from symptomatic uterine fibroids, including those associated with heavy menstrual bleeding. Sonata combines and integrates a high resolution, compact ultrasound probe at the tip of a radio frequency ablation device to provide a single handheld transcervical treatment delivery system under integrated sonographic guidance.

Gynesonics president and chief executive officer Christopher M Owens noted that the company pursued the Category III designation in conjunction with beginning its pivotal investigational device exemption (IDE) Sonata trial.

“This initiative provides us the opportunity to establish a dialogue with the AMA CPT Editorial Panel, the gynecology societies and their advisors to ensure proper procedure coding, while completing our Food and Drug Administration (FDA) Sonata IDE trial,” Owens, said. “Widespread reimbursement coverage for the Sonata technology is essential to making it available to women with fibroids who can benefit from its application. In addition to the FDA IDE Sonata trial, the company will continue to move forward with additional clinical and health economics and outcomes research trials. Our intention is to pursue reimbursement coverage and a migration to a CPT Category I code for the Sonata system upon FDA clearance.”

Merit Medical has announced that it has received 510(k) clearance from the US FDA expanding indication for QuadraSphere microspheres to include the embolization of hepatoma.

Malignant hepatoma, also known as hepatocellular carcinoma (HCC), is the sixth most common cancer and the third leading cause of cancer deaths worldwide. QuadraSphere Microspheres are precisely calibrated and designed to offer controlled, targeted embolization, treating HCC by stopping the blood flow to the tumours.

“The FDA’s clearance of QuadraSphere for the embolization of hepatoma provides another treatment option for patients and physicians in their battle against primary liver cancer,” said Fred Lampropoulos, Merit’s chairman and CEO. “This clearance also represents a milestone in our continual efforts to improve patients’ lives through the development of innovative technologies that produce better patient outcomes.”

BTG has announced that Health Canada has issued a notice of compliance approving Varithena (polidocanol injectable foam) for the treatment of incompetent great saphenous veins, accessory saphenous veins, and visible varicosities of the great saphenous vein system, above and below the knee.

An estimated 3.7 million Canadians have varicose veins, with women twice as likely as men to develop varicosities.

Louise Makin, CEO of BTG plc, said: “We are pleased to receive approval in Canada for Varithena and look forward to the commercial launch during the first half of 2016. The controlled launch continues in the US reimbursed sector, where we consistently receive excellent feedback from physicians in relation to clinical performance and patient acceptability. We are also progressing development of related products for other venous disorders.”

Varithena is a uniform, low-nitrogen, polidocanol microfoam, dispensed from a proprietary canister device. Treatment is minimally invasive, non-surgical and requires neither tumescent anaesthesia nor sedation. It is intended for use in adults with clinically significant venous reflux as diagnosed by duplex ultrasound and is indicated for the treatment of incompetent great saphenous veins, accessory saphenous veins, and visible varicosities of the GSV system, above and below the knee.

Varithena is intended for intravenous injection using ultrasound guidance, administered via a single cannula into the lumen of the target incompetent trunk veins or by direct injection into varicosities. The use of Varithena is contraindicated in patients with known allergy to polidocanol and those with acute thromboembolic disease.

Varithena received US FDA approval in 2013. It is not approved for use in Europe.

Cook Medical has initiated a lot-specific voluntary recall of 2,239 lots of Beacon Tip Angiographic Catheters. Globally, 95,167 devices are subject to this recall. The products include specific versions and lot numbers of the Torcon NB Advantage Beacon Tip Catheters, Royal Flush Plus Beacon Tip High-Flow Catheters, and Slip-Cath Beacon Tip Catheters.

The Beacon Tip Angiographic Catheters have been found to exhibit tip splitting or separation, which has resulted in adverse events. Cook has received 26 complaints of catheter-tip splitting and/or separation. There have been 14 Medical Device Reports to date in which a tip split or separation occurred.

Tip splitting has the potential to lead to loss of device function. Tip separation may require medical intervention to retrieve a separated segment or may occlude blood flow to end organs.

The Beacon Tip Angiographic Catheters in this recall were distributed between June 2013 and June 2015. Product can be identified by the part number and lot number provided on the outer package product label. The lot numbers for products that are subject to this recall can be found on the following pages.

Cook Medical has notified its customers and distributors by recall notification letters. The letters requested that all customers and distributors quarantine and discontinue use of all potentially affected units and return the affected product to the company as soon as possible for credit.

The Journal of Endovascular Therapy (JEVT) has announced the publication of the latest update of the Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II), an internationally recognised set of guidelines for the management of patients with peripheral arterial disease.

Originally published in 2000, the TASC document represents the collaboration of international vascular specialties involved in the treatment of peripheral arterial disease patients. One highly utilised aspect of the TASC guidelines is the TASC anatomical artery lesion classification (A-D), which characterises the various patterns of disease and provides guidance on treatment decisions regarding the optimal revascularisation strategy (endovascular vs. surgical). The TASC II guidelines published in 2007 included a revision of the original TASC classification for peripheral arterial disease patients, with a focus on the aortoiliac and femoropopliteal territories.

“In this update, the classification of disease is extended to involve the below the knee arteries as well. This [Not addressing this anatomical region] was a shortfall of TASC-I and II. In future updates, the hope is to further refine the classification and add recommendations as more data becomes available,” Mahmood K Razavi, an interventional radiologist from Orange County, USA, and one of the authors on the paper in JEVT told Interventional News.

Since the publication of the TASC II document, a number of scientific publications and observational reports have documented the rapid adoption of endovascular therapy as a primary strategy for the treatment of symptomatic peripheral arterial disease patients. The overall result is that there has been an increase in the adoption of the endovascular-first strategy for even the most complex anatomies. This shift was not clearly reflected in TASC II. In addition, the TASC II lesion classification did not include the infrapopliteal arteries, which was an important omission given today’s expanding technologies and techniques for catheter-based tibial and distal interventions for patients with critical limb ischemia. Thus, the focus of the TASC II supplement published today in the JEVT is to update the endovascular and surgical revascularisation strategies and techniques for PAD and to expand the TASC lesion classification to include below-the-knee arteries. The document has been prepared in relationship with a number of vascular societies worldwide and has been endorsed by the ISES.

According to George A Antoniou of the Royal Liverpool University Hospital, whose commentary accompanies the TASC II supplement, “The treatment of peripheral arterial disease patients has seen dramatic evolutionary changes over the past decade. Updates of literature, techniques, and practices by expert committees are an essential tool to facilitate and guide clinical practice.” Given the worldwide importance of this TASC II supplement, the article is being co-published with permission of the authors and SAGE in the following journals: Vascular Medicine, Catheterization and Cardiovascular Interventions, Annals of Vascular Diseases, Journal of the Japanese College of Angiology (Japanese translation), and Técnicas Endovasculares (Spanish translation).

Boston Children’s Hospital physicians report the first cases of children benefitting from 3D printing of their anatomy before undergoing high-risk brain procedures. The four children had life-threatening cerebrovascular malformations that posed special treatment challenges.

Reporting online in late July in the Journal of Neurosurgery: Pediatrics, the physicians describe the use of 3D printing and synthetic resins to create custom, high-fidelity models of the children’s vessel malformations along with nearby normal blood vessels. In some cases, the surrounding brain anatomy was also printed.

“These children had unique anatomy with deep vessels that were very tricky to operate on,” says Boston Children’s neurosurgeon Edward Smith, senior author of the paper and co-director of the hospital’s Cerebrovascular Surgery and Interventions Center. “The 3D-printed models allowed us to rehearse the cases beforehand and reduce operative risk as much as we could.”

The children ranged in age from two months to 16 years old.

The two-month-old infant had a rare vein of Galen malformation in which arteries connect directly with veins—bypassing the capillaries—and was treated with an interventional radiology technique to seal off the malformed blood vessels from the inside.

“Even for a radiologist who is comfortable working with and extrapolating from images on the computer to the patient, turning over a 3D model in your hand is transformative,” says Darren Orbach, chief of Interventional and Neurointerventional Radiology at Boston Children’s and co-director of the Cerebrovascular Surgery and Interventions Center. “Our brains work in three dimensions, and treatment planning with a printed model takes on an intuitive feel that it cannot otherwise have.”

Three of the four children had arteriovenous malformations and were treated surgically.

“Arteriovenous malformations are high-risk cases and it is helpful to know the anatomy so we can cut the vessels in the right sequence, as quickly and efficiently as possible,” says Smith. “You can physically hold the 3D models, view them from different angles, practice the operation with real instruments and get tactile feedback.”

All four children’s malformations were successfully removed or eliminated with no complications. When two of the arteriovenous malformations patients were compared with controls who did not have 3D-printed models—matched for age, size and type of AVM, surgeon and operating room—those with 3D models had their surgical time reduced by 12% (30 minutes). (Actual surgical time was 254 and 257 minutes for the cases with 3D models and 285 and 288 minutes for the controls.) Even a 30-minute reduction is significant for children who are especially sensitive to anaesthesia.

Smith and Orbach are continuing to use 3D models for their trickier cases. “3D printing has become a regular part of our process,” says Smith. “It’s also a tool that allows us to educate our junior colleagues and trainees in a way that’s safe, without putting a child at risk.”

The life-sized and enlarged 3D models were created in collaboration with the Boston Children’s Hospital Simulator Program (SIMPeds) using brain magnetic resonance (MR) and MR arteriography data from each child. Measurements of the models showed 98% agreement with the children’s actual anatomy. 

Emba Medical has announced receiving the European CE mark for the Hourglass peripheral embolization plug making the device the first over-the-wire embolic device cleared for EU commercial release.

Hourglass peripheral embolization plug was awarded a CE certificate on July 10, 2015, enabling the company to pursue commercial activities in EU nations. The Hourglass device represents a breakthrough in peripheral embolization devices in that it is designed to provide precise, secure, over-the-wire delivery and immediate occlusion with a single integrated device, a press release from the company states.

“This is the first integrated, over-the-wire device designed for peripheral embolization procedures,” said George Wallace, CEO of Emba Medical. “The goal with over-the-wire design is to provide physicians with accurate, stent-like delivery of the device in the vessel. We believe that the Hourglass implant will provide a level of confidence, precision, and control for peripheral embolization procedures that physicians have come to enjoy over the years while performing other types of over-the-wire endovascular procedures.”

Andrew Cragg (Minneapolis, USA) interventional radiologist and Hourglass co-developer, noted: “The Hourglass device is designed to provide immediate occlusion in a wide range of vessel sizes with a single device. The device’s unique design was created to take advantage of natural haemodynamic forces to provide immediate, focal, stable occlusions.”

The device is not approved for sale in the United States.

The US FDA has approved the Reshape Integrated Dual Balloon System (ReShape). The system is a temporary weight-loss system of gastric balloons that are placed in a minimally invasive manner to occupy space in the stomach. They should be removed after six months.

The Reshape Dual Balloon system consists of two attached balloons that are filled and sealed separately. The balloons are placed into the stomach through the mouth using an endoscopic procedure while the patient is under mild sedation. Once in place, the balloons are filled with saline and methylene blue. When it is time to remove the balloons, they are first deflated then removed using another endoscopic procedure.

The device is for use in adult obese patients who have a body mass index (BMI) of 30-40 kg/m2 who have been unable to lose weight through diet and exercise. Patients must also have one or more obesity-related conditions such as diabetes, high blood pressure, or high cholesterol. Reshape Dual Balloon is intended to be used while a patient participates in a diet and exercise plan supervised by a healthcare provider.

In the REDUCE pivotal clinical study, a prospective, randomised multicentre study to evaluate the safety and efficacy of the intragastric balloon system in obese patients as an adjunct to diet and exercise in the treatment of obese patients with one or more obesity-related comorbid conditions, the group of people who used this device lost more weight than those who did not use it. The study included a total of 326 patients at eight investigational sites in the USA. Of the 326 patients, 187 received the device and 139 underwent the endoscopic procedure but did not receive the device. All study participants received diet and exercise counselling.

Patients with the device lost an average of 14.3 pounds (25.1% of their excess weight and 6.8% of their total body weight). The patients who did not receive the device lost an average of 7.2 pounds (11.3% of their excess weight and 3.3% of their total body weight).

The device should not be used in patients who have had previous gastrointestinal or bariatric surgery; have gastrointestinal inflammatory disease; have potential upper gastrointestinal bleeding conditions; have a gastric mass; have a large hiatal hernia; have structural abnormality in the oesophagus or pharynx; have serious oesophageal motility disorders; have severe coagulopathy; have hepatic insufficiency or cirrhosis; have serious alcoholism or drug addition; have serious or uncontrolled psychiatric illness or disorders; are pregnant or are breastfeeding or plan to become pregnant; have ever developed too much serotonin (serotonin syndrome) and are currently taking any drug known to affect serotonin levels; use aspirin, anti-inflammatory agents, anticoagulants, or other gastric irritants daily; are known or suspected to have an allergic reaction to materials in the device; are unwilling or unable to participate in a medically-supervised diet and behaviour modification programme; and take prescribed proton pump inhibitor medication for the duration of the device implant.

Guerbet has announced entering into a definitive agreement under which it will acquire Mallinckrodt’s contrast media and delivery systems business in its entirety for approximately US$270 million. With this acquisition, Guerbet aims to create a new global leader in medical imaging.

The key strengths of the contrast media and delivery systems business as identified by Guerbet are:

• An efficient industrial and commercial platform with four production sites in Ireland and in North America and a global distribution network covering approximately 65 countries,
• A comprehensive range of delivery systems and imaging solutions for X-ray scanners, X-ray cardiac and vascular imaging, urological imaging and magnetic resonance imaging,
• A large portfolio of patents and other intellectual property rights.

For the first six months of fiscal 2015, Mallinckrodt’s CMDS business recorded sales of close to US$210 million.
Under the terms of the agreement, Guerbet is acquiring 100% of the contrast media and delivery systems business including the production sites, the intellectual property rights and the distribution subsidiaries in the various geographical areas, in a transaction valued approximately US$270M, entirely paid in cash and financed through term loan facilities syndicated by BNP Paribas.

The transaction is subject to customary closing conditions and is expected to close in the next few months. Guerbet’s works council has unanimously issued a favourable opinion in respect of the acquisition of the contrast media and delivery systems business.

Yves L’Epine, Guerbet’s CEO comments: “This acquisition transforms and accelerates Guerbet’s future: it doubles our turnover, enables us to extend our geographical footprint and creates complementarities in both contrast media and imaging solutions and services. We will be very pleased to welcome Mallinckrodt’s contrast media and delivery systems business colleagues to successfully and rapidly complete this integration together after the closing and create a new global leader in medical imaging”

Preclinical research published online ahead of print in the Journal of Vascular and Interventional Radiology (JVIR) in July shows that combretastatin A4 is a stronger inhibitor of the smooth muscle cell cycle than sirolimus or paclitaxel. Thus, it may represent an alternative coating for drug-eluting stents and balloons in atherosclerotic luminal stenosis, the investigators write.

Sirolimus and paclitaxel are drugs that are loaded onto a wide variety of drug-eluting or drug-coated device platforms for use in the coronary arteries and periphery. For example, Ultimaster, is an example of a sirolimus-eluting bioabsorbable coronary stent (Terumo) and Zilver PTX (Cook Medical), a peripheral paclitaxel-eluting stent system that has shown beneficial long-term effects in combating femoropoliteal disease.

Researchers Daniel Spira and colleagues set out to compare the effects of sirolimus, paclitaxel, and combretastatin A4 on the regulatory proteins of the cell cycle in proliferating smooth muscle cells.

Spira and colleagues treated human aortic smooth muscle cells with sirolimus, paclitaxel, and combretastatin A4 at 5×10-9 mol/L. After one day, half of the cells were harvested (D1 group). The treatment medium of the other half was replaced with culture medium on day four, and those cells were harvested on day five (D5 group). Cyclins D1, D2, E, and A and cyclin-dependent kinase (CDK) inhibitors p16, p21, and p27 were detected by Western blot technique. Quantification was performed by scanning densitometry of the specific bands.

As reported in JVIR, the researchers found that in the D1 group, treatment with sirolimus resulted in decreased intracellular levels of cyclins D2 and A (p0.05). In the D1 group, combretastatin A4 decreased intracellular levels of cyclins D2, E, and A (p<0.05). Despite recovery effects in the D5 group (increase of cyclins D1, D2, and A compared with D1 group; p<0.05), the upregulation of the CDK inhibitor p21, increased D cyclins, and decreased cyclins E and A (p <0.05) are compatible with a G1 arrest.

“The effect of combretastatin A4 on neointima formation should be evaluated further,” the authors recommend.

Factfile

• Combretastatin belongs to a class of natural phenols (and despite its name, is unrelated to statins). Several natural combretastatin molecules are found in the bark of South African Bush willow trees.
• Paclitaxel (also called Taxol) is found in the bark of yew trees.
• Sirolimus is the generic name for the natural product rapamycin and is produced by a strain of Streptomyces hygroscopicus.

Metactive announced that it has received a phase I National Institutes of Health (NIH) grant to fund comparative studies of its embolization device, Blockstent microcatheter.

The grant proceeds will be used to continue the development of a novel over-the-wire Blockstent microcatheter embolic device for the occlusion of peripheral arteries and veins. Nonclinical research data presented as a poster at the 2015 Annual Meeting of the Society of Vascular Surgery in June, showed immediate and complete occlusion of axillary and internal thoracic arteries and 100% complete occlusion at four week follow up in a small number of cases (seven).

“This grant will fund larger nonclinical studies comparing the acute and chronic performance of the Blockstent Microcatheter vs. commercially available vascular occlusion devices such as coils and mesh plugs, which can be difficult to use and often result in incomplete treatment,” stated Howard M Loree II, vice president of Research and Development for Metactive and principal investigator for the new grant. “We believe that Blockstent has the potential to enable more precise device placement; faster, more complete, and more durable blood vessel occlusion; and fewer complications relative to currently available devices and look forward to continuing our development programme with the support of this new NHLBI grant funding.”

According to a press release from the company, more than 150,000 peripheral vascular embolization procedures are performed each year worldwide using coils and vascular plugs. Similarly, more than 150,000 cerebral aneurysm embolization procedures are performed worldwide each year using coils and flow-diverting vascular stents. “There is currently a need in these markets for endovascular embolization devices that can be placed quickly and easily, with a high degree of precision, and that result in immediate and lasting occlusion,” the release further adds.

In 2014, the company presented data on one of its investigational devices at the Society of Interventional Radiology’s (SIR) Annual Scientific Meeting. Metactive presented findings from a pilot nonclinical study in which the company’s cerebral aneurysm embolic device demonstrated immediate and complete mechanical occlusion of a large, terminal saccular aneurysm, as well as full endothelialization and sealing of the aneurysm neck at one month. By comparison, in the same aneurysm model, treatment using widely used conventional coils did not provide immediate and complete occlusion. Compared to coiling, the procedure to place Metactive’s device took half as long, and the devices cost one-third as much.

Each year, nearly 40,000 Americans undergo elective surgery to repair an abdominal aortic aneurysm (AAA) with the goal of preventing a life-threatening rupture of this potentially dangerous cardiovascular condition. A new study from researchers at Beth Israel Deaconess Medical Center, Boston, USA, compared open surgical repair with a catheter-based procedure and found that the less invasive endovascular aortic repair (EVAR) has clear benefits for most patients, providing both a safer operation and a quicker recovery. The study was published in The New England Journal of Medicine.

“Abdominal aortic aneurysm is common, especially among men over the age of 65 who have ever smoked and among individuals with a family history of the condition,” said lead author Marc Schermerhorn, chief of vascular surgery at Beth Israel Deaconess Medical Center and associate professor of surgery at Harvard Medical School.

In order to evaluate long-term outcomes of the durability of EVAR, the researchers examined US Medicare data from 2001–2008 involving nearly 80,000 patients who had undergone elective repair of AAA. Half of the patients had open procedures, and half had EVAR.

“We found that endovascular repair was markedly superior to open repair for the first 30 days, that it continued to be superior for the next 60 days, and the benefits endured for at least three years,” said Schermerhorn. “Our research also suggests that the EVAR outcomes have been improving over time.”

“The fact that EVAR outcomes have been improving over time is particularly important,” said senior author Bruce Landon, a member of the Division of General Medicine and Primary Care at BIDMC and professor of Health Care Policy and Medicine at Harvard Medical School. “Our findings suggest that even as sicker patients have undergone EVAR, the short- and long-term outcomes have continued to improve, and the results seem durable.”

“When we compared the data between groups, we saw an early survival benefit for EVAR patients,” Schermerhorn added. “In the 30 days after surgery or the time of hospitalisation if longer than 30 days, the EVAR mortality rate was 1.6% compared with 5.2% for open procedures.”

The patients in the EVAR cohort also had lower rates of perioperative medical and surgical complications like pneumonia and had shorter hospital stays, with an average 3.5 days spent in the hospital, compared with 9.8 days for the open repair group. EVAR patients were also more likely to go home after surgery, rather than to a rehabilitation centre or a nursing home.

The researchers found that the survival advantage of EVAR over open repair decreased over time—after eight years, survival rates for the two groups were virtually even. They also found that interventions for surgical incision complications were more common after open repair. Interventions related to the management of the aneurysm or its complications were more common after EVAR, but most of these were minor procedures that could also be performed with a minimally invasive procedure.

“Importantly, aneurysm rupture occurred in 5.4% of EVAR patients who survived for eight years versus 1.4% of patients who received open repair,” said Schermerhorn. ”The importance of this key finding is that we need to focus our efforts at minimising this risk after EVAR. Patients need to come back for follow-up after endovascular surgery and undergo these additional interventions, if needed, to prevent late rupture.”

The results of this large, eight-year study extend the findings of earlier studies.

“Results from smaller randomised trials of selected patients treated at institutions in the UK, the Netherlands and the United States Veterans Affairs system were reproduced broadly here in the US Medicare population,” said Landon. “But, these new results represent a much larger study population and double the years of follow up.”

The study results, together with prior analyses from the research team, also suggest that surgeons are appropriately selecting which patients will benefit most from EVAR, particularly older and sicker patients who may not have been treated in the past.

“AAA rupture is still a common cause of death. Because there are typically no warning signs, heightened awareness among patients and physicians is needed,” said Schermerhorn. “AAA can be diagnosed with a simple ultrasound and can now often be treated with an effective, durable, minimally invasive approach.”

Carestream Health entered the radiography/fluoroscopy market with two systems that deliver high-quality, cost-effective imaging: the Carestream DRX-Excel Carestream DRX-Excel Plus.

These systems can enhance workflow and perform contrast exams using fluoroscopy that can be associated with a radiography image, in addition to specialised contrast procedures that record both fluoroscopy and radiography sequences and interventional procedures, a press release from the company says.

Carestream’s DRX-Excel systems are configured with a table and a tube in one system. An optional integrated flat panel detector produces high-resolution images for general radiography as well as fluoroscopic sequences. The DRX-Excel platform also is available as a conventional radiography/fluoroscopy system that uses either CR cassettes or DRX-1 detectors with an image intensifier.

“We are expanding our radiography leadership to include fluoroscopy, which is performed by many of the hospitals and imaging centres we serve,” said Diana L Nole, president, Digital Medical Solutions, Carestream. “This is a natural extension for both our company and our customers, and enables healthcare providers to benefit from purchasing these systems from a single supplier with a strong reputation for outstanding service and support.”

Both DRX-Excel systems offer a source-to-image detector distance of 180cm, an ergonomic design and the ability to select an image intensifier for fluoroscopy or use the optional flat panel detector. The DRX-Excel Plus has an elevating table that tilts for fluoroscopy exams and can be lowered or raised to provide flexible, comfortable imaging for patients. Table weight capacity is 265Kg. The DRX-Excel has a fixed table with a weight limit of up to 200Kg and has the tilt capability for fluoroscopy exams.

Both systems feature productivity-enhancing capabilities including a positioning pedal that allows the operator to have their hands free—which is helpful for interventional exams—and a remote control that can move the table from anywhere in the room. Other options include integration of a detector; four-way float top table movement; and the ability to stitch multiple images together for long-length exams.

In the USA, only the DRX-Excel Plus model will be available. Both systems will be available in Europe, Asia, Latin America and other countries.

Kem Hawkins, president of Cook Group Incorporated, retired on July 1 after 34 years with the Cook organisation. Hawkins will remain on the board of directors for Cook Group. Pete Yonkman, current president of Cook Medical, has been chosen as Hawkins’ successor as president of Cook Group.

“Under Kem’s leadership, we have seen exciting new opportunities to help patients, our employees, and the communities where we operate,” said Carl Cook, CEO of Cook Group. “With his guidance, our company experienced unparalleled growth in sales from US$500 million to US$2 billion and growth in the number of employees from 4,000 to 12,000 globally. Kem has successfully led the company through challenging times, significant growth, and a shifting global health care landscape.”

Hawkins joined the Cook organization June 1, 1981, as a management trainee and operations manager. In 1983, Hawkins moved to Denmark to act as operations manager for William Cook Europe. Upon his return in 1985, he became general manager of Cook’s Critical Care division and was promoted to vice president of Critical Care in 1990. Hawkins’ years in Critical Care led to new partnerships with physicians and the development of new products that saved countless lives. He then became interim president of Wilson-Cook Medical, executive vice president of Cook Critical Care, and, in 2001, president of Cook Group and Cook Incorporated.

Hans van Overhagen and Jim A Reekers from The Netherlands have authored the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) Standard of Practice guidelines for transcatheter uterine artery embolization (UAE) for symptomatic leiomyomata and these have been published in Cardiovascular and Interventional Radiology (CVIR). The authors urge that every symptomatic patient with uterine myomas should be offered embolization as alternative treatment to hysterectomy/myomectomy. “UAE should be incorporated in the (national) gynaecological guidelines,” they report.

The standard of practice guidelines outline the pre-treatment imaging, indications for treatment and contraindications, patient preparation, equipment specifications, procedure, medication and peri-procedural care, post-procedural follow-up and care, outcome and effectiveness and complications associated with UAE.

The authors write that UAE is a true alternative to hysterectomy in women who want to preserve their uterus, a statement that is backed by level one evidence. Further, they find that the highest quality of evidence shows that the five-year outcome in quality of life is equal in groups treated either by hysterectomy or by UAE, with no difference in major complications. Van Overhagen and Reekers point out that level one evidence also shows that a 15–20 % hysterectomy rate has to be expected during follow-up after successful embolization and that in the short-term, UAE had lower blood loss, shorter hospital stay and quicker return to work. The authors further conclude that the risk for ovarian dysfunction after UAE seems over-estimated in women less than 40 years of age.

The indications for UAE are heavy menstrual bleeding, mechanical complaints, such as pain, pressure, dyspareunia, urinary urgency and frequency. Van Overhagen and Reekers emphasise that all possible candidates for UAE should undergo assessment by a gynaecologist with training and experience. “The examination should confirm the diagnosis of leiomyomata and exclude a viable pregnancy and/or active infection or malignancy of the vagina, cervix, uterus and ovaries. All candidates should also undergo assessment by the attending interventional radiologist in order to be informed about the procedure, clinical success rates, complications and follow-up,” they note.

The absolute contradictions to receiving UAE are pregnancy, malignancy of the uterus or ovaries (unless the procedure is being used for palliation or as an adjunct to surgery and active uterine infection. A relative contraindication is the patient desire to preserve childbearing potential. The authors make it clear that the effect of UAE on fertility has not been well investigated and that preservation of fertility is not assured from the current literature. However, uncomplicated pregnancies and normal deliveries have been reported after UAE, as also conflicting results regarding the effect of UAE on pregnancy and miscarriage rates. “Thus, this procedure may be considered for women who are not candidates for myomectomy, however, not as a first choice option,” they write.

Other anatomical features may also play a role for the procedure to be relatively contraindicated: pedunculated subserosal fibroids with thin stalks; a common arterial supply of uterus and ovaries; and the presence of intrauterine device must be taken into account (However, the authors point to a recent series of 20 women, accidentally embolized with an IUD in situ did not show any infectious side effects, level 4 evidence). General contraindications for endovascular procedures including contrast material allergy, impaired renal function and coagulopathy also apply, and these may be treated before UAE.

With regard to complications, as reported in CVIR, major complications of both hysterectomy and UAE are rare and equal in the randomised trials. “Major complications are reported in up to 5% during and within the first month of the procedure. Pulmonary embolism and deep vein thrombosis are reported in less than 1%. Transcervical expulsion of fibroid tissue, occasionally necessitating surgery in ±5% of procedures and major infection in 2.5%. There have been three reported deaths due to UAE. In randomised clinical trials, common complications are discharge and fever (4%), technical failure (4%) and post-embolization syndrome (3%). Amenorrhea is reported in ±4% of women, permanent in less than 2%,” the authors write.

Patients with unresectable metastatic colorectal cancer (mCRC) that has spread only to the liver experienced the greatest improvement in progression-free survival in the liver from the addition of SIR-Spheres Y-90 resin microspheres to a current first-line chemotherapy regimen, according to new data from the SIRFLOX study presented at the European Society for Medical Oncology (ESMO) 17th World Congress of Gastrointestinal Cancer (WCGIC; 1–4 July, Barcelona, Spain).

The new findings from the 530-patient SIRFLOX randomised controlled study were presented by Guy van Hazel, co-principal investigator of the SIRFLOX study and clinical professor of medicine at the University of Western Australia, Perth, Australia.

“As our group reported earlier at the 2015 ASCO meeting in Chicago, liver tumours began to grow again after a median of 12.6 months in patients with mCRC who received only first-line chemotherapy, even with the optional addition of bevacizumab, while those who also received first-line treatment with SIR-Spheres Y-90 resin microspheres reached a median of 20.5 months before their liver disease progressed. This additional 7.9 month added treatment benefit represents a significant 31% reduction in the risk of tumour progression in the liver for patients treated with SIR-Spheres Y-90 resin microspheres. This finding applied to all patients in the study, whether they had metastases only in the liver or in other sites as well,” van Hazel said.

“Our new analyses focused on the impact of two important factors on this treatment benefit. The first of these is that among the 318 patients with metastases that had spread only to the liver at the time they entered the study, median progression-free survival in the liver was 21.1 months for those treated with SIR-Spheres plus chemotherapy, compared to 12.4 months for those treated with chemotherapy alone. This 8.7 month improvement was statistically significant (p=0.003, with a hazard ratio of 0.64) and represents a notable 36% reduction in the risk of tumour progression in the liver,” van Hazel explained.

van Hazel also disclosed new findings regarding the impact of bevacizumab in the chemotherapy regimen used in the SIRFLOX study. “In both groups—the 292 patients who had an intention to treat using bevacizumab in addition to first-line mFOLFOX6 chemotherapy, and the 238 who did not—the addition of SIR-Spheres Y-90 resin microspheres resulted in a statistically significant 8.3 month delay and 31% reduction in the risk of disease progression in the liver (hazard ratio 0.69). The clinical benefit of adding SIR-Spheres Y-90 resin microspheres to first-line chemotherapy appears to be independent of the use of bevacizumab,” he stated.

Turning his attention to the side effects seen with the addition of SIR-Spheres Y-90 resin microspheres, van Hazel stated that, “The clinical benefit we observed was accompanied by an acceptable level of adverse events resulting from the addition of Y-90 resin microspheres to first-line chemotherapy in mCRC. This matters because oncologists familiar with the effects of radiation on healthy liver tissue have traditionally been very cautious of irradiating large liver volumes. SIRFLOX has now shown that we can we deliver high doses of radiation to the liver tumours safely, even with the concurrent administration of a potent chemotherapy regimen.”

Summarising the impact of the new SIRFLOX findings, van Hazel concluded that, “Even in the absence of a statistically significant improvement in progression-free survival at all sites, as was the case in SIRFLOX, and even as we await overall survival data from the combined 1,100-patient SIRFLOX, FOXFIRE and FOXFIRE global studies in 2017, these new pre-planned sub-group findings for progression-free survival in the liver should lead oncologists to consider adding SIR-Spheres Y-90 resin microspheres to first-line chemotherapy. The liver remains the organ to which colorectal cancer spreads first, and for those patients who are ineligible for potentially curative liver-resection, liver failure due to the growth of liver metastases will unfortunately be the ultimate cause of their death, which makes our findings especially relevant for mCRC patients diagnosed with liver metastases.”

While there is a trend towards using smaller sized particles to obtain better results with embolization, clinical and research experts at the recently held Global Embolization Symposium and Technologies (GEST EU; 24–27 June, Seville, Spain) agreed that there appeared to be a lower size limit, <100µm, below which drug-eluting beads did not have an effective embolic effect.

J Irurzun, Alicante, Spain, speaking on the distinguishing characteristics of drug-eluting embolics noted that there was a need to “verify the limits in the trend” towards using smaller sized drug-eluting embolics. He suggested that there was a need to understand the peculiarities (and characteristics) of individual drug-eluting embolics as well as to obtain a good suspension and slow infusion of 1–3ml/minute.

Julian Namur, Jouy en Josas, France, speaking on the in vivo behaviour of drug-eluting embolics told delegates that below a certain size, drug-eluting embolics did appear to be less effective.

In relation to the published literature, Hasmukh J Parjapati and colleagues’ paper published in the American Journal of Roentgenology (AJR) in December 2014, that set out to investigate the overall survival, efficacy, and safety of small (100–300µm) vs large (300–500 and 500–700µm) doxorubicin TACE using drug-eluting beads in patients with unresectable hepatocellular carcinoma (HCC), showed that TACE with 100–300µm sized drug-eluting beads is associated with significantly higher survival rate and lower complications than TACE with 300–500 and 500–700µm sized DEB.

At GEST EU 2015, Irurzun also noted that there was a case to repeat the PRECISION V trial using TACE with drug-eluting beads in the size range of 100–300µm.

The PRECISION V randomised trial compared conventional transarterial chemoembolization (cTACE) with TACE using DC Bead (BTG) for the treatment of cirrhotic patients with HCC. Two hundred and twelve patients with Child-Pugh A/B cirrhosis and large and/or multinodular, unresectable HCCs were randomised to receive TACE with DC Bead loaded with doxorubicin or cTACE with doxorubicin. Results from the trial showed that the hypothesis of superiority for DC Bead was not met. However, patients with Child-Pugh B, ECOG 1, bilobar disease, and recurrent disease showed a significant increase in objective response (p=0.038) compared to cTACE. DC Bead was associated with improved tolerability, with a significant reduction in serious liver toxicity (p<0.001) and a significantly lower rate of doxorubicin-related side effects (p=0.0001). The investigators concluded that TACE with DC Bead and doxorubicin is safe and effective in the treatment of HCC and offers a benefit to patients with more advanced disease.

Katerina Malagari, Athens, Greece, one of the investigators on the PRECISION V trial, echoed Irurzun’s views and told Interventional News that there did appear to be a size threshold around >100µm, below which drug-eluting embolics appeared to lose their embolic effect. There is, however, data demonstrating that between 100µm and 300µm, “there is increased effectiveness for these embolic agents,” she said. “In the light of this data, there is a case to be made for repeating the PRECISION V randomised trial in a using TACE with drug-eluting beads that are sized between 100 and 300µm, rather than 500 and 700µm as were those that were used in the original PRECISION V trial,” she noted. 

Hansen Medical has announced it will exhibit its Magellan Robotic System at the Global Embolization Symposium and Technologies (GEST) Scientific Meeting 24–27 June at the FIBES II New Conference Centre in Seville, Spain.

During this year’s GEST meeting, the Magellan Robotic System will be featured in a scientific session entitled “Cutting Edge Technology” and in a company sponsored symposium. On 26 June, there will be a discussion about intravascular robotics in the parallel session, titled cutting edge technology in the main auditorium from 2:15 to 3:45pm. This will also see the presentation on robotic-assisted embolization by Marc Sapoval, Paris, France.

Hansen is also sponsoring an educational symposium on Wednesday, June 24 from 6:00 to 6:30 pm, called “Clinical Update on Robotic Embolization.” Two speakers, Marc Sapoval and Mohamad Hamady, London, UK, will discuss the role of robotic technology in providing enhanced precision, control and radiation protection in endovascular procedures. This session will take place in the FIBES II – New Conference Centre, Bruselas Lecture Room.

“The GEST meeting attracts medical experts from all over the world to discuss and debate the latest advances in embolization therapies,” said Cary Vance, Hansen Medical’s president and CEO. “We are excited that Magellan will be discussed as a cutting edge technology. Magellan enables patients to benefit from robotic precision and control in these [embolization] procedures, while helping to protect physicians from the harmful effects of exposure to ionising radiation.”

Terumo Interventional Systems had introduced the Misago RX self-expanding peripheral stent to the US market at the 2015 Society for Vascular Surgery Annual Meeting (SVS; 17–20 June, Chicago, USA).

The Misago stent system consists of a nitinol stent pre-mounted on the distal portion of a rapid-exchange delivery catheter. Designed and developed in Japan, it is now available to treat patients in the USA with peripheral artery disease in the superficial femoral artery (SFA) and/or proximal popliteal artery.

The Misago stent has been available outside of the USA since 2008. It has been studied in more than 5,000 patients in numerous clinical trials. The US Food and Drug Administration (FDA) granted premarket approval for the device in May. FDA approval was based on submission of one-year data from OSPREY (Occlusive/stenotic peripheral artery revascularization study), a single-arm, multicentre, non-randomised prospective clinical trial for the treatment of atherosclerotic stenosis and occlusions of the SFA. In one of the first “harmonisation by doing” initiatives between the USA and Japan, the study included patients enrolled in the USA, Japan, Taiwan and Korea.

“The lack of differences in outcomes among the patients studied supports the validity of multi-national trials which will streamline approvals in different nations and maximise resources while reducing costs. I can foresee future trials which build upon our harmonisation study design” said Takao Ohki, chief primary investigator for the international trial.

Data from the OSPREY study demonstrated the following:

• The flexible, durable design offers a low potential for stent fracture. In the OSPREY trial there was a 0.9% incidence of stent fracture per stent at 12 months post-procedure.
• A simplified thumbwheel system allows for precision deployment by a single operator at the lesion site. Physicians in the OSPREY study reported 100% success in delivering Misago to the lesion site.
• Sustained patency of 82.9% as measured at one-year using Kaplan-Meier analysis (PSVR of less than or equal 2.4).
• 88.6% per cent freedom from target lesion revascularisation, as measured at one-year using Kaplan-Meier analysis.

“The MISAGO stent has a flexible design and good radial force that we found performed well in the superficial femoral artery” said John Fritz Angle, principal investigator for the US clinical trial. “Peripheral artery disease can have devastating consequences but we believe the Misago stent offers a durable treatment option for superficial femoral artery disease.” Angle presented the results of the OSPREY study at the SVS Meeting.

“We look forward to partnering with the US interventional medical community to bring the benefits of this novel technology, as well as others in the future, to patients in the US,” said Chris Pearson, vice-president marketing at Terumo Interventional Systems. “We express our gratitude to all the OSPREY investigators that helped to advance the scientific knowledge of the Misago stent.”

The widely varying progressions of cancer require comprehensive diagnostics, an early check of treatment, and the exchange of information with colleagues. Siemens says that its new version of the diagnostics software syngo.via supports the treating physician in making decisions regarding treatment in oncology through a comprehensive portfolio of applications across imaging systems, treatments, and disciplines.

Imaging procedures play an important role in treatment planning. Multimodal image material not only provides information for a precise assessment of the tumour with regard to its position, morphology and metabolism, but it also forms the basis for radiotherapy planning. The application syngo.via RT Image Suite supports the radiotherapy oncologists in the demanding task of optimally using clinical images from various sources such as CT, MRT or PET-CT in order to contour the tumour to be irradiated and the surrounding tissue to be spared.

Another part of the oncology software portfolio is the application syngo.MR OncoCare. Siemens says that this software allows an early, quantitative evaluation of the response of the tumour to the treatment. It allows conclusions to be drawn about the success of the selected treatment method and, if necessary, this method can be adapted. Thus, the patient is spared from the continuation of ineffective treatment and the unnecessary costs associated with it.

In order to define the best possible treatment for each individual patient and successfully treat cancer, a wide variety of medical disciplines are drawn upon. Their representatives come together in regular, interdisciplinary meetings on this topic in so-called tumour boards. Syngo.MI Offline Oncoboard provides an IT solution in order to be able to present syngo.via findings of the various imaging procedures even on a standard PC and independently of a network connection.

Delcath has announced that abstracts summarising the data from two European studies of treatment with the Delcath Hepatic Chemosat Delivery System will be presented at the upcoming Cardiovascular and Interventional Radiological Society of Europe (CIRSE) annual meeting (to be held in Lisbon, Portugal, 26–30 September).

The abstracts are: “Safety and efficicacy of the Delcath second generation filter in percutaneous hepatic perfusion with melphalan for unresectable hepatic metastases of colorectal cancer and uveal melanoma”, a study conducted at the Netherlands Cancer Institute by MC Burgmans and colleagues and “Lessons and early results from the largest single-centre experience in Europe of treating ocular melanoma liver metastases with chemosaturation via percutaneous hepatic perfusion, a study conducted at Southampton University, UK, by G Hickson and colleagues.

Delcath’s proprietary melphalan hydrochloride for injection for use with the Delcath Hepatic Delivery System is designed to administer high-dose chemotherapy to the liver while controlling systemic exposure. In April 2012, the company obtained authorisation to affix a CE mark to the second-generation system, which is currently marketed in Europe as a device under the trade name Delcath Hepatic Chemosat Delivery System for melphalan. In the USA, the system is considered a combination drug and device product and is regulated as a drug by the US FDA. It has not been approved for sale in the USA.

Delcath recently also announced that Jennifer Simpson was named president and CEO by the company’s Board of Directors. Simpson has served as interim president and CEO of Delcath since September 2014 and as interim co-president and co-CEO from September 2013 to September 2014.

AngioDynamics has announced a worldwide licensing agreement with privately-held EmboMedics of Minneapolis, USA, which develops injectable and resorbable microspheres. Embolization is the fastest growing segment in interventional radiology, and this newly formed strategic relationship will allow AngioDynamics to leverage the talent and knowledge of its sales team to re-enter the approximately US$150 million addressable global embolic market.

“AngioDynamics previously helped to build the embolics market, and with worldwide rights to a margin accretive, truly novel technology, we are poised to emulate that success,” said Joseph M DeVivo, president and CEO of AngioDynamics. “We believe resorbable microspheres represent the future of embolotherapy, allowing for more options in the treatment of patients, and we are excited about the prospect of bringing this technology to our customers worldwide.”

Under the terms of the agreement, AngioDynamics receives an exclusive worldwide license to market and sell, upon regulatory clearances, EmboMedics’ microsphere technology. AngioDynamics will also control manufacturing of the products.

AngioDynamics will make an initial US$2 million equity investment in EmboMedics through the purchase of preferred stock. The company may make an additional US$9 million in equity, as well as milestone driven investments, and can execute an exclusive option to acquire EmboMedics, based on the achievement of certain milestones.

Spherical and compressible, EmboMedics’ technology is designed to break down over time, resulting in reabsorption and elimination by the body. This action may lead to recanalisation of the treated arteries, allowing for repeat procedures to occur through the previously embolized vessels.

“EmboMedics has focused on advancing minimally-invasive embolization with resorbable technologies, improving the patient experience by designing biodegradable materials that will no longer remain in the arteries indefinitely,” said Omid Souresrafil, CEO and co-founder of EmboMedics. “We are excited to partner with AngioDynamics, leveraging our technology with its world class sales force and distribution network as we look to introduce our product to the global marketplace.”

EmboMedics expects to submit for US FDA 510(k) clearance to market the device as a resorbable microsphere for the embolization of hypervascular tumours by January 2016. Founded in 2012, EmboMedics obtained exclusive commercialization rights from The University of Minnesota, which developed the microsphere technology. This deal is not expected to have a material impact on fiscal year 2015 financial results.

Medtronic has launched the Fortrex over-the-wire (OTW) percutaneous transluminal angioplasty (PTA) balloon catheter. Fortrex utilises a high pressure balloon to break up the blockages and open the vessels to help maintain arteriovenous access in the peripheral vascular system.

“Being able to maintain arteriovenous access for patients receiving haemodialysis for renal disease and kidney failure is critical as it is a patient’s lifeline,” said Brian L Dunfee, interventional radiologist, Holmes Regional Medical Center in Melbourne, USA. “In the past, other high pressure balloons could lose their shape, making it challenging to focus the pressure on the lesion that was blocking the arteriovenous access. Fortrex’s rated burst pressure provides me with a predictable and efficient solution to crack the short, fibrous lesions to restore access.”

The Fortrex PTA balloon can be used to maintain arteriovenous access in patients receiving haemodialysis for chronic kidney disease or end stage renal failure. In some cases, patients receiving haemodialysis will develop plaque blockages at the dialysis site, which can limit access. The Fortrex balloon’s material and design permit shape retention at rated burst pressure, ensuring focused pressure on the lesion for controlled, targeted and predictable treatment.

Additionally, the balloon has been engineered with a low tip entry profile and robust, flexible shaft to enable tight tracking to the wire and successful navigation in tortuous vessels. The balloon material and wall thickness enables reliable balloon rewrap and reinsertion. This, combined with its rapid deflation time, improves efficiency of the procedure.

BTG has announced the treatment of the first patient in Singapore with TheraSphere, a treatment for primary liver cancer and metastatic colorectal cancer, specifically engineered to deliver powerful doses of radiation to the tumour while minimising exposure to normal tissue in a procedure called radioembolization.

Stephen Chang, associate professor Liver, Tumour Group Lead and senior consultant, National University Cancer Institute, Singapore and National University Hospital, said: “Liver cancer is a deadly disease that impacts hundreds of people in Singapore each year and has a high mortality rate. This newly available therapy aims to destroy tumour cells, while maintaining the patient’s quality of life.”

A press release from BTG notes that TheraSphere is a targeted therapy that consists of millions of glass microspheres containing radioactive yttrium-90. The microspheres are about 20-30 micrometers in diameter – about a third of the width of a human hair. They are delivered directly to liver tumours through the hepatic artery using a catheter. The glass microspheres flow directly into the liver tumour via its blood vessels and become permanently lodged there. Because the procedure delivers the treatment directly to the liver tumour, the radiation destroys the tumour cells with minimal impact to the surrounding healthy liver tissue. The radioactive microspheres continue to deliver radiation to the tumour over the course of several weeks after treatment. TheraSphere can also be used as a bridge to surgical removal of diseased tissue or transplantation in these patients, the release adds.

In Singapore TheraSphere is approved for both hepatocellular carcinoma, and metastatic liver cancer or cancer that has spread to the liver from another point of origin. Distributed in Singapore by Transmedic PTE, TheraSphere is also commercially available in Hong Kong. Over 18,000 patients worldwide have been treated with TheraSphere.

The National University Hospital in Singapore, and more than 20 hospitals across Asia, will also be participating in three international phase III clinical trials of TheraSphere.

• The EPOCH trial, evaluating TheraSphere in patients with metastatic colorectal carcinoma (mCRC) of the liver who have failed first-line chemotherapy.
• The STOP-HCC trial, evaluating TheraSphere in the treatment of patients with unresectable hepatocellular carcinoma.
• The YES-P trial, evaluating TheraSphere vs. the standard of care (sorafenib) for the treatment of advanced hepatocellular carcinoma with portal vein thrombosis.

A study presented at the Society of Interventional Radiology’s (SIR’s) 2015 annual scientific meeting reveals that a new angiographic imaging platform (AlluraClarity, Philips Healthcare) maintains similar procedure time as a current C-arm imaging platform (Allura, Philips), yet with substantially reduced radiation exposure for uterine artery embolization procedures.

These findings have particular relevance for the many women undergoing uterine artery embolization who are of child-bearing age, as well as for the interventional radiology staff present in the room during the procedure.

Rüdiger Egbert Schernthaner, a member of Jean-Francois Geschwind’s research team at the Johns Hopkins University, Baltimore, USA, set out to quantify the radiation exposure reduction of a new C-arm imaging platform for women with symptomatic uterine fibroids who were treated with uterine artery embolization. 

In this ongoing prospective trial, twenty nine consecutive patients with symptomatic uterine fibroids were treated either on the new dose reduction imaging platform (n=15; AlluraClarity) or the reference imaging platform (n=14; Allura). X-ray dose logging was performed using a dedicated Radiation Dose Structured Reporting (RDSR) server.

The new system uses optimised acquisition parameters to lower the radiation exposure and real-time image processing algorithms such as noise reduction, temporal averaging and automatic pixel shift to restore the image quality.

Air kerma, the radiation exposure in free air before reaching the body, dose area product, the absorbed radiation dose multiplied by the area irradiated and acquisition time for digital fluoroscopy and digital subtraction angiography were recorded. The body mass index of patients was also noted. Unpaired t-tests and Wilcoxon rank-sum tests were used to assess statistical differences between the platforms. 

The investigators found that there was no difference in body mass index between the two patient cohorts. “Additionally, there was no significant difference in digital fluoroscopy or digital subtraction angiography time between the new and reference platforms, indicating that the procedure courses were similar between the two cohorts,” Schernthaner said.

“Compared to the reference platform, the new platform significantly reduced the cumulative air kerma and dose area product by 57% and 66%, respectively (p2, p=0.04) and 80% (65.5 vs. 320.5 Gy*cm², p<0.001), respectively,” he reported.

“The reduction of radiation exposure to only 20% of the standard system during digital subtraction angiography is especially important when considering that a number of interventional radiologists reported during the SIR meeting that they restrict the use of digital subtraction angiography in an attempt to lower the radiation exposure, but at the cost of an increased risk of non-target embolization,” Schernthaner explained.

Schernthaner is an attending radiologist at the Medical University of Vienna, Vienna, Austria.

Dose reduction for visceral embolization procedures

A similar study, also presented at the SIR annual meeting, that set out to evaluate the impact of a Alluraclarity on radiation dose during visceral embolization procedures for both fluoroscopy and digital subtraction angiography, has found that the new technology lowers the radiation dose during these procedures considerably.

Frederic Baumann, Miami Cardiac & Vascular Institute, Miami Baptist Hospital, Miami, USA, reported the results of the study showing that the ClarityIQ (Philips) technology was shown to significantly reduce radiation dose for visceral embolization procedures.

Baumann told delegates that dose was highly reduced even in patients with increased body mass index. “Therefore, further scrutiny of this new imaging software is warranted for endovascular therapies,” Baumann said.

The researchers included data from a consecutive series of patients undergoing endovascular visceral embolization to carry out a retrospective, single-centre data analysis after approval by the local institutional review board. They compared the data from visceral procedures performed between July 2013 and April 2014 using ClarityIQ technology data from patients treated with the former AlluraXper technology, which was used from May 2011 to June 2013.

Baumann and colleagues categorised patients into three groups based on their body mass index: group 1 included patients whose body mass index was less than 25 kg/m²; group 2 included those whose body mass index was above 25 and below 30 kg/m² and group 3 included patients whose body mass index I was greater than 30 kg/m². They also measured procedure time, fluoroscopy time, the total dose of ionised contrast administered and air kerma for the quantification of radiation dose were obtained. Air kerma was furthermore adjusted per fluoroscopic minute (AirKerma PFM).

“A total of 100 patients using ClarityIQ (59 were male, mean age: 70.6 years) were compared to 139 patients using AlluraXper (71 were male, mean age: 70.1 years). We found that the procedure time was shorter for AlluraXper (91.4 vs. 108.3 minutes, p=0.004), whereas fluoroscopy time and the amount of contrast media were equally distributed,” Baumann said.

He noted that comparing ClarityIQ and AlluraXper, airKerma was 1342.9±1080.1 vs. 2214.8±1826.8 (p<0.001) and AirKerma PFM was 61.8±47 vs. 103.2±65.6 (p<0.001), respectively.

Researchers from Stanford University have created a mobile application to allow rapid identification of all inferior vena cava filter types and related complications. This scrollable app can be used to optimise care of patients with inferior vena cava filters, especially those with indwelling filters, they say. The app can run on Apple (iOS) and Google (Android) platforms and is ready for public launch.

“There are now many different inferior vena cava filter types, each with unique potential complications, that rapid and correct identification is challenging when encountered on routine imaging,” Steven Deso and William Kuo, Vascular and Interventional Radiology, Stanford University Medical Center, Stanford, USA, said.

The researchers set out to develop an interactive mobile application that allows recognition of all inferior vena cava filter types in the USA and their related complications, to optimise care of patients with indwelling filters. They reported their progress in the Emerging Technologies Scientific Session at the SIR’s annual meeting, Atlanta, USA.

The researchers obtained data from 1980 to 2014 from the FDA premarket notification database to identify all filter types in the USA and found 22 filter types for inclusion. Then, from the safety data of the US FDA MAUDE (Manufacturer and User Facility Device Experience) and 72 relevant peer-reviewed studies, they acquired and classified the major complications into seven types: fracture, embolization, perforation, recurrent venous thromboembolism, insertional issues, and inferior vena cava occlusion.

The team then identified all reported complications associated with each filter, and the highest reported complication rates for each filter were highlighted in the application. They also incorporated high-resolution photos of each filter type from a pristine filter collection. Further, they acquired corresponding CT and fluoro images of each filter and each complication type.

A study from Institut Bergoniè (Bordeaux, France), in collaboration with Università Campus Bio-Medico di Roma (Rome, Italy), that set out to compare the duration of targeting and positioning of radiofrequency ablation electrode on lung tumours using two different modalities finds that cone-beam CT is faster than CT.

“Irrespective of lesion size, cone-beam CT allows faster lung radiofrequency ablation than CT,” Roberto Luigi Cazzato, Rome, Italy, told delegates at the European Congress of Radiology (ECR, 4–8 March, Vienna, Austria).

The investigators prospectively enrolled and randomised patients referred for lung radiofrequency ablation due to primary or metastatic lung tumours to receive cone-beam CT- or CT-guided ablation. They also stratified patients into three groups based on lesions size. Group 1 consisted of patients with lesions <10mm in diameter; group 2 had patients with 10–20mm lesions and patients in group 3 had lesions ≥20mm. The researchers registered and compared the time needed to target and place the radiofrequency ablation electrode within the lesion in all groups. They also investigated the instances of electrode repositioning, the time needed for it, complications with the ablation procedure and local recurrence after ablation.

Forty tumours were treated in 27 patients (19 male, age 67.25±9.13 years). Thirty radiofrequency ablation sessions were performed (16 under cone-beam CT-guidance and 14 under CT guidance).

“Our results showed that the time required to target and place the radiofrequency ablation electrode was significantly shortened when cone-beam CT-guidance was applied, irrespective of lesions size (p < 0.05). Electrode repositioning occurred while treating 6/18 (33.3%) tumours under cone-beam CT-guidance and 9/22 (40.9%) tumours under CT-guidance. Electrode repositioning took longer under CT guidance across all lesion sizes,” Cazzato said.

In terms of complications, pneumothorax occurred in 6/14 (42.8 %) radiofrequency ablation sessions conducted under CT guidance and in 6/16 (37.5 %) conducted under cone-beam CT guidance. In the end, across the entire follow-up, three (3/19, 15.8%) recurrences were noted in the group of tumours receiving CT-guided ablation and two (2/17, 11.7%) recurrences occurred among those receiving cone beam CT-guided ablation.

“The study, conducted under the supervision of Jean Palussière, chief, Department of Radiology, Institut Bergoniè, highlights that in institutions where interventional radiologists have limited access to CT scanners, cone-beam CT installed in the angiosuite represents a valuable option to perform lung ablation. In fact, the safety of the procedure under cone-beam CT guidance is comparable to that available under traditional CT guidance. Technically speaking, in our experience, the constant control of the electrode granted by the navigation system available on the cone-beam CT machine was straightforward. It is possible that organs other than lung may benefit from such a cone-beam CT-guided approach. For example, in the particular setting of liver tumours, a certain advantage of cone-beam CT could be the possibility to perform ablation and embolization for large-sized lesions in the same session,” Cazzato said.

The study design and initial 30-day safety data of the BEAT Obesity (Bariatric embolization of arteries for the treatment of obesity) study were presented at the SIR annual scientific meeting in Atlanta.

Bariatric embolization is a minimally invasive, image-guided therapy targeting the functionality of the stomach. It involves the targeted delivery of embolics to defunctionalise specific portions of the stomach that produce the hunger hormone, ghrelin.

BEAT Obesity is a physician-sponsored investigational device exemption single-arm prospective clinical trial for five to 15 morbidly obese patients. The embolic agent used (off-label) is 300–500μm Embosphere microspheres (Merit Medical) and the primary endpoints are weight loss and 30-day adverse events.

Clifford R Weiss, Radiology/Vascular and Interventional Radiology, The Johns Hopkins University School of Medicine, Baltimore, USA, presenting the update on the study said that of over 50 patients screened, 15 had been consented. Of these, six were excluded due to active Helicobacter pylori infections, diabetes, anatomic variants on CT , ulcers and polyps on screening endoscopy. “Three patients have been embolized to date and a further two are scheduled for the procedure,” he said.

The procedure consists of a series of steps beginning with coeliac digital subtraction angiography via the femoral approach. This is followed by cone-beam CT of the coeliac using the Zeego (Siemens). Then, selective digital subtraction angiography of the gastroduodenal artery and splenic artery are performed, followed by selective angiography of the left gastric artery. The researchers then embolize the left gastric artery using Embospheres to stasis. This is followed by digital subtraction angiography of the left gastric and repeated coeliac angiography and cone-beam CT, if contrast and dose area product (DAP) allow.

The BEAT Obesity results showed that the average procedure time was 143±39.2 minutes; fluoroscopy time was 22.8±8.6 minutes; radiation dose was 4546.7±267.3mGy; contrast dose was 182.3±55.9cc and volume of beads delivered was 3.3±0.6cc,” Weiss said.

The 30-day results showed that there were no major adverse events. The median weight loss was 10.3±6.4lbs. There was one hospital admission for nausea and vomiting.

Weiss added: “Early evidence suggests that bariatric embolization is a safe and effective treatment for morbid obesity. Aggressive diet intervention is essential and should begin well before bariatric embolization. It is important to assess the anatomy of the patient before the procedure, and as a specialty we must learn how to manage these patients in a multidisciplinary fashion.”

Bariatric embolization using polyvinyl alcohol particles

Research from Korea, presented at the European Congress of Radiology (ECR, 4–8 March, Vienna, Austria), shows that bariatric embolization using non-spherical polyvinyl alcohol particles works to suppress ghrelin in swine models.

J Kim, Seoul, Korea, told delegates that this type of embolization can significantly suppress ghrelin level. “However, we identified ulcerations in the stomach in 50% of experimental animals. Three (50%) animals also demonstrated recanalisation of the embolized vessels in follow-up angiography,” he said.

The investigators performed embolization using an infusion of 150–250µm polyvinyl alcohol selectively into the gastric arteries that supply the fundus. Six healthy swine underwent bariatric embolization, while five control animals underwent a sham procedure with saline. Plasma ghrelin levels were obtained in animals at baseline and at every two weeks. Endoscopy was performed three weeks after bariatric embolization to look into the occurrence of ulceration in stomach. Repeated angiography of the coeliac trunk was done to determine the durability of the occluded arteries. And necropsy was performed eight weeks later.

Kim reported that the pattern of change in ghrelin levels over time was different between control and experimental animals. Average postprocedure ghrelin values maximally decreased in experimental animals at week five relative to baseline.

Premedication with an oral antioxidant cocktail before medical imaging exams could significantly reduce deoxyribonucleic acid (DNA) injury from the ionising radiation dose, finds new research presented at the Society of Interventional Radiology’s annual scientific meeting in Atlanta, USA.

“An oral antioxidant cocktail of seven pills including beta-carotene, vitamin C, alpha lipoic acid and n-acetyl cysteine offered prior to medical imaging for screening or intervention, may result in a reduction in cancer induction risk. Our results suggest that antioxidant pre-medication can protect DNA from damage induced by X-rays in medical imaging exams. The implications for cancer induction are speculative,” said Kieran Murphy, University Health Network Toronto Western Hospital, Toronto, Canada, who was presented the 2015 SIR Foundation Leaders in Innovation Award.

Murphy highlighted that the volume of medical imaging exams is constantly increasing with patients being exposed to ionising radiation every day, particularly in the context of computed tomography, X-ray and fluoroscopy. The exposure occurs in radiology departments, but also in the operating room, cardiac catheterisation labs, etc. “Diagnostic imaging examinations, computed tomography and fluoroscopy in particular, are associated with radiation doses generally ranging between 0.02 and 40mSv2 and may cause malignant transformation of patient’s cells and tissues which, many years later, manifest as cancer or posterior chamber cataracts. Cancer risk from medical imaging exams is a function of age. Patients who are particularly at risk include those undergoing complex cardiac PET CT, chemotherapy, gallium scans, MRI radiofrequency coils and high fields. Interventional radiologists should also consider the risks they expose themselves to on a daily basis,” he noted.

Murphy explained that the mutagenic effect of ionising radiation is clearly established through a variety of molecular mechanisms including double stranded DNA breaks, single DNA strand breaks, nucleotide substitution and sugar/ribose alterations.

“A cell responds to focal DNA damage through initiation of a biochemical repair mechanism constituting a protein complex being bound to the DNA strand at the defect. Every cell has a DNA repair apparatus. This is a protein complex that fixes DNA lesions before the cell replicates, without this apparatus, we would all get cancer. The mechanism is a complex of repair proteins, one of which is gamma-H2AX,” Murphy explained.

Whilst there are several major biochemical tests to quantify DNA damage, the most sensitive involves quantifying DNA damage with 3D microscopy using fluorescently labeled gamma-H2AX protein.

“Our initial work focused on in vitro antioxidant premedication. In these cases we would pipette antioxidants into blood tubes prior to their irradiation to test a treatment effect. We also measured reduction in DNA injury as a function of antioxidant dose. Initially we used high radiation doses (~2Gy) to best demonstrate an effect. Then we proceeded to lower doses more typical of diagnostic exams. We saw a substantial reduction in DNA injury as a result of antioxidant premedication and so began to study the ability of antioxidant chemicals to decrease the genetic damage associated with CT examinations,” he noted.

The researchers performed a prospective randomised study in 10 patients undergoing technetium methylene diphosphonate bone scans with identical doses. Patients were randomised to premedication (5) or no premedication (5). The patients were given a set of oral antioxidants one hour before they were scheduled to receive a bone scan.

“Premedication with our current formulation of antioxidants significantly reduced formation of gamma-H2AX and 53BP1 foci after injection of a clinically standard radiation dose of technetium for a bone scanning. Based on this experience, 60 minutes prior to Tracer injection was adequate to achieve a 90% reduction in foci,” Murphy noted.

In the control bone scan patients, the gamma-H2AX foci in lymphocytes post radiation were significantly higher than seen pre-radiation, suggesting that there had been significant DNA damage and subsequent repair initiated. On the other hand, in the bone scan patients who received the antioxidant treatment, the gamma-H2AX foci in the lymphocytes were not significantly raised after radiation, suggesting that there had been less radiation damage.

Interventional News has learnt that interventional radiologists and urologists in France are teaming up to set up a multidisciplinary registry to collect data on prostatic artery embolization for the treatment of benign prostatic hyperplasia.

Marc Sapoval, professor of clinical radiology and chair of the Cardiovascular Radiology department, Hôpital Européen Georges-Pompidou in Paris, France, said: “The French registry will assess the safety and efficacy of prostatic artery embolization. Patients referred for bothersome lower urinary tract symptoms (LUTS) who are contraindicated to, or refuse, surgery, and those with chronic urinary retention or bleeding of prostatic origin will be included. The registry will be co-managed by the French interventional radiology and urological scientific societies (SFR and AFU) and will use an online case report form. It will be launched in the third quarter of 2015.”

A similar multidisciplinary registry in the UK, the UK-ROPE, is funded jointly by the National Institute for Health and Care Excellence (NICE), the British Society of Interventional Radiology (BSIR) and the British Association of Urological Surgeons (BAUS). The registry documents patient selection criteria; all complications, specifically sexual dysfunction, and efficacy outcomes and includes measures of urinary function, symptoms and quality of life.

In the UK registry, two cohorts will be compared; one that undergoes surgical treatment and the other that undergoes prostate artery embolization. “Whilst not a randomised controlled trial, these two cohorts will be matched for age, prostate size and symptoms as is practicable. Surgical treatments will include transurethral prostatectomy (TURP), holmium laser prostatectomy (HoLEP) and open prostatectomy,” Nigel Hacking, interventional radiologist at University Hospitals Southampton, UK, told Interventional News in 2014.

Prostate artery embolization using PErFecTED technique

A single-centre, prospective study presented at the European Congress of Radiology (ECR, 4–8 March, Vienna, Austria), found that prostatic artery embolization using the PErFecTED technique does improve lower urinary tract symptoms with no significant complications.

Francisco Carnevale et al have previously described the PErFecTED technique for benign prostatic hyperplasia in the CardioVascular and Interventional Radiology (CVIR).

As described in the journal:“Prostatic artery embolization requires a refined technique to achieve good imaging and clinical success. The PErFecTED (Proximal embolization first, then embolize distal) technique has produced greater prostate ischaemia and infarction than previously described methods with clinical improvement of lower urinary symptoms and lower recurrence rates. The microcatheter should cross any collateral branch to the bladder, rectum, corpus cavernosum, or penis and be placed distally into the prostatic artery before its branching to the central gland and peripheral zone. This technique allows better distribution of embolic material in the intraprostatic arteries and reduces risk of spasm or thrombus. Because benign prostatic hyperplasia develops primarily in the periurethral region of the prostate, the urethral group of arteries should be embolized first. Subsequent distal investigation and embolization completes occlusion and stasis of blood flow to the prostatic parenchyma. Since we added the second step to the PErFecTED technique, we have observed infarcts in all patients submitted to prostatic artery embolization,” the authors write.

“The PErFecTED technique as recently described by Carnevale et al is a two-step process during embolization of each prostatic artery. As soon as the microcatheter is selectively in place inside the prostatic artery, there is a ‘proximal embolization’, with a delivery of microparticles until complete stasis. Then the tip of the microcatheter is pushed further inside the prostatic artery (in the medial branch) in a distal position, and after a digital subtraction angiography run showing the reappearance of prostatic blush, there is a second step of ‘distal’ embolization, again until complete stasis,” Gregory Amouyal from the Hôpital Européen Georges-Pompidou team, who presented the study.

He also told delegates that long-term follow-up is needed to confirm the durability of prostate artery embolization.

Patients with symptomatic benign prostatic hyperplasia were included after failure of medical treatment if they refused surgery and had a prostate volume >40mL. The study evaluated data from 25 consecutive patients (mean age 65) treated between December 2013 and November 2014 after urological and interventional radiological baseline assessment.

Patients underwent hyperselective prostatic artery embolization with 300-500µm trisacryl microspheres, under local anaesthesia, as an outpatient treatment, or with a short one-night hospital stay.

The primary endpoints for clinical success were: International Prostatic Symptom Score (IPSS) -25% or ≤18, Quality of life score reduction of at least one point or ≤3, or peak urinary flow rate (Qmax) -25% or ≤7mL/s at three or six-month follow-up.

The investigators had 100% technical success and no major complications (such as vesical or rectal necrosis). They observed post-embolization syndrome including mild fever and pollakiuria in all patients. At the three-month follow-up, there was data of clinical success for 19 out of 25 patients. At the six-month time frame, there was follow-up information and clinical success for 13 out of 18 available patients. “After a mean follow-up of 5.1 months, we observed significant decrease in IPSS (59%), QoL (-2.8) and prostatic volume (-24%). We had no retrograde ejaculation after prostatic artery embolization,” Amouyal said.

Allium Medical has announced that it has received FDA clearance to market Gardia’s Wirion system in the United States for the carotid indication.

Asaf Alperovitz, CEO of Allium Group said: “Receiving FDA clearance to market the Wirion system in the US for the carotid clinical indication is a major achievement for Allium. […] The success in achieving all clinical endpoints [of the pivotal, multicentre trial], including the primary endpoint, based on half of the number of patients defined in the study protocol, while meeting stringent statistical criteria, is unprecedented for embolic protection devices. Meeting the clinical endpoints already at this early stage enabled us to streamline the process for obtaining FDA approval and to significantly shorten the timetable. “The Gardia Wirion system, which has been used successfully in over 350 procedures, in a variety of clinical indications, received a very favourable feedback from leading European physicians. The system includes significant competitive advantages over other FDA cleared embolic protection devices of world leading companies.”

About the system:

A press release from the company adds that the Wirion system is a unique, patent-protected embolic protection filter-type system that protects against blood clots and emboli produced during catheterisation procedures for opening blocked blood vessels. The system has a unique locking mechanism that allows the physician to use the any guide wire of choice and to place the filter in the most suitable and desired location. The flexibility to place the filter anywhere over any guide wire simplifies and streamlines the procedure, making it safer, convenient, and simple to use thus presenting significant advantages over other protection devices in the market. The Wirion system also includes a unique retrieval catheter for easy, quick and safe filter retrieval after stent deployment.

It is approved in the US for the clinical indication of emboli protection during carotid artery catheterisation procedures and in Israel (AMAR) and Europe (CE mark) for widespread use in all cardiovascular catheterisation procedures.

A combination of imaging systems from Siemens Healthcare is helping Southmead Hospital, Bristol, UK, to achieve its aim of becoming a leading provider of health services in Europe. With the hospital’s new £430m Brunel building offering pioneering treatment within state-of-the-art facilities, Siemens technology is increasing the speed of patient assessment and enabling elevated levels of patient throughput.

Southmead Hospital, part of North Bristol NHS Trust, is now utilising a selection of Siemens imaging systems, including the Artis zee biplane, Artis Zee MP and Artis Q Ceiling with a Maquet operating table within a Hybrid Operating Room environment supporting a wide range of clinical examinations and interventions. Seven high-end digital radiography Ysio systems are providing general X-ray imaging. The addition of this technology has facilitated rapid imaging—essential to a busy hospital that sees more than 400,000 patients annually.

“Ensuring that the highest levels of service were maintained during the successful transfer to the new Brunel Building was of paramount importance to us and patients are now experiencing sizeable benefits at our extensive and all-encompassing site,” states Bob Robson, imaging services manager at Southmead Hospital. “The imaging technology from Siemens has significantly improved patient flow, and the ability to see images immediately and make a swift, detailed assessment has led to sizeable efficiency gains.”

The Artis systems are being used by clinicians for a range of neuroradiology, vascular radiology, trauma and cardiac diagnostic procedures, while the Ysio technology is supporting trauma, orthopaedics, general medicine and outpatient clinics.

“Siemens’ diagnostic technology was selected for its reliability and ease-of-use, a significant benefit given that over 130 radiographers rely on it on a 24/7 basis,” adds Robson. “The digital radiography element provided by the Ysio systems has been highly advantageous, enabling us to significantly improve patient throughput levels.”

The Artis systems provide clinicians with the benefits of a large flat detector and a streamlined tableside control panel featuring intuitive syngo icons, offering the operator increased functionality. The systems are also equipped with the latest CARE (combined applications to reduce exposure) features and CLEAR post processing technology, supporting excellent image quality at the desired dose. In addition, Siemens’ high-end digital radiography Ysio system offers advances that enable clinicians to achieve enhanced image quality, with other key benefits including swift image acquisition time, low dose features and the lightweight wireless detector that enables easy examination of a range of patients.

Philips has announced the launch of Ultrasound on Demand in the UK, an on-demand ultrasound solution which will go live on 1 June 2015.

Philips says that the service provides clinicians with access to the “best technology at an affordable monthly fee, offering extensive functionality and the assurance that it can meet the ever changing needs placed on busy hospital departments”. Designed to offer clinicians a range of ultrasound packages that are charged for when used, it means that clinicians can personalise the service that they need now and in years to come as demand and patient throughput changes.

Given its flexibility, with more than 50 options, Ultrasound on Demand will also enable clinicians to access a host of advanced facilities such as 3D Transesophageal Echo, where previously they were limited by the restrictions of necessary upfront investment costs.

Ultrasound on Demand’s approach gives clinicians the ability to explore new options and “future-proof” their services, letting them upgrade and alter their systems without locking in capital expenditure budgets as additional functionality is only charged when used. Philips says that this flexibility removes obstacles to more advanced and specialised treatments and may also encourage clinicians “to push clinical barriers further”.

“We see Ultrasound on Demand as a significant innovation,” said Katie Taylor, group director of Imaging & Cardiology at BMI Healthcare. “It provides the opportunity to test clinical applications that a site may not have used before such as elastography, using advanced software, or abdominal scanning using 3D Xmatrix software. It will help us move beyond the conventional use of our systems and consider how, with this wider range of tools, we can increasingly provide specialist services to our patients and grow our expertise.”

Ultrasound on Demand has been tested and modelled to establish the a wide scope and range of work. It is designed with patients and clinicians in mind by providing a system that can be easily altered, and supports clinician’s decisions with visualisation tools such as usage and tracking data.

Philips will be offering Ultrasound on Demand system nationally, and hopes to present its findings later in 2015.

The positive 30-day results from 120 patients out of a planned 240 patient cohort at high risk for endarterectomy, who underwent carotid artery stenting using the Wirion embolic protection device (Allium Medical), were published in EuroIntervention and presented at EuroPCR 2015 (19–22 May, Paris, France).

Embolic protection in carotid artery stenting procedures have been shown to reduce the rate of major adverse cardiac and cerebrovascular events associated with the procedure. The 30-day results from this study have shown that the Wirion embolic protection device in carotid artery stenting is safe and highly effective when compared to historical data in a population that includes high-risk patients.

This early European experience from Alberto Cremonesi, Villa Maria Cecilia, Cotignola, Italy, and colleagues, using a novel guidewire-independent distal filter showed that the system is simple to use and highly rated by users. “The ability to cross the lesion over a guidewire of choice and deploy the filter in the exact desired location creates a unique, natural and appealing advantage for all indications,” the authors write in EuroIntervention.

At EuroPCR 2015, Bernhard Reimers, Cardiology Department, Mirano Hospital, Mirano, Italy, presented the results.

Earlier in March this year, the company announced the decision to stop recruiting additional patients in view of the successful compliance with all clinical trial objectives at this early stage.

The Wirion embolic protection device is a rapid exchange pre-crimped distal filter system that can be used with any 0.014” guidewire. It is a stent-like system in form and operation. The Wirion system is deployed after a 0.014” guidewire of choice is positioned across the lesion in a standard fashion. Then, the Wirion standalone filter unit can be delivered, positioned and locked anywhere along the guidewire, resulting in smooth crossing of the lesion and optimal protection position along the artery. The Wirion embolic protection device has received the CE mark and is at an advanced stage in the application for US FDA approval.

One hundred and twenty patients who were considered high-risk for surgery were enrolled in the WISE study. The mean age of the cohort was 73.9 years. Fourteen patients were symptomatic and 106 were asymptomatic. The lesions treated had an average stenosis of 84%.

“The 30-day composite primary endpoint of major cardiac and cerebrovascular event (MACCE) was 3.3%, with 0% death. Of these patients, one patient had contralateral stroke and a second patient had type 2 NSTEMI secondary to new untreated anaemia. Both were decided by the clinical event committee as non-procedure-related events. Only two patients (1.7%) experienced procedure-related events. The MACCE rate in the WISE study group was compared with an historical control group of high-surgical-risk patients showing significantly better performance. The device success rate was 99.2% and angiographic success was achieved in 97.5%,” the authors write.

The abstract, published by the ASCO as part of the 2015 annual meeting abstracts released on its website, reveals that Sirtex’s SIRFLOX study of 530 patients revealed median progression-free survival (PFS) in the liver of 20.5 months, an improvement of 7.9 months over the current standard chemotherapy plus Avastin.

SIRFLOX was an international, multicentre, open-label, randomised controlled trial in chemotherapy-naïve patients with non-resectable, liver only or liver dominant (liver plus lung and/or lymph node metastases) metastatic colorectal liver cancer.

Gibbs is a consultant medical oncologist, The Royal Melbourne Hospital, Australia.

The topline preliminary results released earlier this year showed that the study did not meet its primary endpoint, ie, in the first line treatment of non-resectable metastatic colorectal cancer, the addition of SIR-spheres resin microspheres to a current chemotherapy regimen does not result in a statistically significant improvement in overall progression-free survival. However, the study does show a statistically significant improvement in progression-free survival in the liver when SIR-spheres, a liver-directed therapy, are used.

The SIRFLOX study shows an additional 7.9 months (20.5 months vs. 12.6 months), which is a 62.7% improvement in median progression-free survival in the liver for patients whose treatment included SIR-Spheres Y-90 resin microspheres. Patients whose treatment included SIR-Spheres microspheres had a 31% lower risk (HR=0.69) of the tumours in their liver progressing during the time they were on the SIRFLOX study. Study authors confirm that median progression-free survival in the liver was significantly extended and the addition of SIR-Spheres microspheres was associated with acceptable toxicity.

Gilman Wong, CEO of Sirtex said: “The reduction in the risk of tumour progression in the liver, coupled with the statistically significant nature of the result is encouraging.”

Ricky A Sharma, Gray Institute for Radiation Oncology and Biology, University of Oxford, UK, has been independently selected by the ASCO Scientific Program Committee to be the expert discussant for the SIRFLOX study results and two additional abstracts.

A summary of the other key findings in the SIRFLOX study abstract were:

• Overall progression-free survival, the primary endpoint of the SIRFLOX study was not improved in a statistically significant way via the addition of SIR-Spheres microspheres. Median overall progression-free survival was 10.7 months in the SIRSpheres microspheres plus a modified fluorouracil, leucovorin, and oxaliplatin chemotherapy regimen (mFOLFOX6)±bevacizumab arm vs. 10.2 months in the mFOLFOX6±bevacizumab arm, p=0.428.

• Overall tumour response rate, a secondary endpoint in the SIRFLOX study was 76.4% in the SIR-Spheres microspheres+mFOLFOX6±bevacizumab arm vs. 68% in the mFOLFOX6±bevacizumab arm, with a p value of p=0.113.

• Hepatic response rate, a secondary endpoint in the SIRFLOX study was 78.7% in the SIR-Spheres microspheres+mFOLFOX6±bevacizumab arm vs. 68.8% in the mFOLFOX6±bevacizumab arm, p=0.042.

• The complete response rate in the liver was 6% in the SIR-Spheres microspheres+mFOLFOX6±bevacizumab arm vs. 1.9% in the mFOLFOX6± bevacizumab arm, p=0.02.  This result indicates that patients who received SIR-Spheres microspheres as part of their treatment experienced approximately a threefold higher rate of complete disappearance of tumours in their liver, compared to patients who did not receive SIR-Spheres microspheres.L

  iver resection rate, a secondary endpoint in the SIRFLOX study was 14.2% in the SIR-Spheres microspheres+mFOLFOX6±bevacizumab arm vs. 13.7% in the mFOLFOX6±bevacizumab, p=0.857. 

  The overall survival data from the SIRFLOX study is required to be combined with the FOXFIRE and FOXFIRE Global studies to provide sufficient statistical power in over 1,000 patients globally to detect a clinical significant difference in overall survival between the SIR-Spheres microspheres and control arms. Overall survival pooled data is anticipated during the first half of 2017. 

  The study authors concluded “In first-line treatment of patients with non-resectable colorectal cancer liver metastases, the addition of selective internal radiation therapy (SIRT) to standard chemotherapy failed to improve overall progression free survival. However, median liver progression free survival was significantly extended. The addition of SIRT was associated with acceptable toxicity. Overall survival analyses, combining data from SIRFLOX and two other ongoing studies in this disease setting, are awaited.”

Hansen has announced the completion of the world’s first clinical procedure with the Magellan 10F robotic catheter. Interventional radiologist Gerard Goh performed the procedure at The Alfred Hospital in Melbourne, Australia. He used the 10F catheter during a robot-assisted placement of an inferior vena cava filter.

The procedure was supported in partnership with Medtel Pty, Hansen’s exclusive distribution partner for the Magellan robotic system in Australia and New Zealand.

The Magellan 10F robotic catheter is the latest addition to the family of robotic catheters used with the Magellan robotic system. The 10F catheter allows for independent, robotic control of two telescoping catheters (an outer guide and an inner leader catheter). The guide catheter has a 10F outer diameter, and features the largest inner lumen (7F) in the Magellan catheter family, which enables delivery of therapeutic devices through the robotic catheter in a broader range of endovascular procedures. The Magellan 10F robotic catheter received CE mark approval in April 2015.

“The Magellan 10F robotic catheter will enable us to expand our use of intravascular robotics in minimally-invasive, endovascular procedures,” said Goh. “The larger, 7F inner lumen accommodates many more therapeutic devices, including stents, balloons, and in this case, an IVC filter. The device tracked well through the catheter, and we were able to benefit from the robotic precision and stability that we have experienced during previous therapy delivery with the Magellan 6F and 9F catheters.”

The Magellan system’s remote workstation allows physicians to control robotic catheters and guide wires while seated away from the radiation field, which has been shown to reduce radiation exposure for the physician by as much as 95% in complex endovascular procedures.

EndoShape has announced that it has been selected to present at the Cavendish Global Health Impact Forum taking place 10–14 May in La Jolla, USA.

The purpose of the Forum is to help family offices and foundations develop and implement their individual pro-social impact investing, grant-giving, and philanthropy programmes within health and the life sciences. To accomplish this mission, the Forum showcases presentations and panel discussions by leading research institutions, accomplished healthcare delivery professionals, health-policy experts and private-sector companies engaged in developing innovations with the potential for transformational impact on disease prevention, diagnosis and treatment.

The next Forum is being co-hosted by the community of La Jolla, California including The University of California San Diego, The J Craig Venter Institute, The Scripps Research Institute, The Sanford-Burnham Medical Research Institute, The Sanford Consortium for Regenerative Medicine, and The Institute of the Americas.

Michael Moffat, Cavendish co-founder and CEO explains, “The theme of our La Jolla, California Forum is a ‘celebration of philanthropy, impact investing and innovation that is changing the world.’ With the help of our expert advisors, we conduct a global search of research institutions and private-sector companies in order to identify organisations that meet the required standard of excellence. The quality and originality of EndoShape’s research and scientific insights in polymer development and embolization technology positions them to make a major contribution to the treatment of many clinical indications including liver cancer, trauma, neurovascular conditions and pelvic congestion syndrome.”

“We are honoured to be selected to present at this unique event, and it is further recognition of our innovative approach to peripheral and neurovascular embolization” said Bill Aldrich, president and CEO, EndoShape. “We welcome the chance to interact with many of world’s most accomplished scientists, thought-leaders and generous philanthropic individuals and families who are all dedicated to the common cause of improving the health and lives of people around the world.”

Quiremspheres, that were developed by the University Medical Center (UMC) Utrecht, The Netherlands, to be used in a new treatment for liver cancer, have received the European CE mark for quality and safety. The treatment is being marketed by Quirem Medical, a spin-off company of the UMC Utrecht.

A press release from the company states that receiving the CE mark implies that hospitals in Europe can now start using radioembolization using radioactive holmium microspheres to attack liver tumours. The procedure involves injecting radioactive beads into the hepatic artery, which then join the blood flow and become trapped in the tiniest blood vessels, located in and around the liver tumours. They therefore emit their radiation close to the tumour.

Patient-specific treatment

“We consider our holmium microspheres as ‘the next generation of microspheres,’” says Frank Nijsen, founder of Quirem. “Treating liver tumours with yttrium microspheres is already a proven and valued cancer therapy using radioembolization. The new holmium microspheres constitute the next step in the development of this technology. Because they show up on MRI scans and SPECT-CT, these microspheres can be tracked, allowing customised treatment for each individual patient. Now that we have been awarded CE marking, patients all over Europe can benefit.”

The UMC Utrecht has been working for fifteen years to develop this innovative treatment modality. For the last six years, patients with liver tumours have been undergoing the treatment in a scientific setting. The spin-off company, Quirem Medical, was founded in 2013 to make the treatment available also to patients outside the UMC Utrecht. “The CE marking reflects our ambition to make our technology available to people around the world,” Jan Sigger, CEO of Quirem Medical, points out. “We can now work to further develop this holmium treatment together with our clinical partners.”

Other organs

The research group at UMC Utrecht in charge of the project will work closely with Quirem Medical to adapt the new treatment for treating tumours in other organs as well. This year, research will start on the use of holmium microspheres to treat head and neck tumours. For that application, too, the unique image guidance with MRI introduces possibilities for closely monitoring the localised treatment of tumours and optimising it as needed.

“I expect great things from this holmium therapy,” says Maurice van den Bosch, an interventional radiologist at the UMC Utrecht. He was closely involved in the development of this new treatment. “Patients with liver tumours will benefit, and I hope that we will be able to treat patients with other tumours more effectively in the future as well.”

Surefire Medical has announced that the company’s new Precision targeted delivery infusion system, for direct-to-tumour embolization procedures, has received the CE mark from European regulators. Surefire infusion systems are today used primarily in treating inoperable liver cancers, although clinical trials are under way for additional medical conditions.

“This product with its improved trackability will enable significant growth opportunities for Surefire Medical in the large worldwide primary liver cancer market,” said president and CEO James E Chomas. “The rapidly growing body of clinical evidence indicates greater drug penetration into tumours with the unique Surefire infusion systems, which addresses a clear need in a treatment of primary liver cancer that can bridge patients to a liver transplant or extend their life by suppressing tumour growth.”

A press release from the company states that the value of the primary hepatocellular cancer (HCC) market is set to grow by 172% by 2019, according to independent analyst firm Datamonitor Healthcare.

It further adds that HCC is the most common form of liver cancer, accounting for 83% of total liver cancer incidence. With approximately 80% of liver cancers being inoperable, today many patients are treated with a minimally invasive embolization procedure performed by an interventional radiologist.

VesselNavigator has been designed for use in conjunction with Philips’ interventional X-ray systems to guide catheters during treatment of vascular disease. The new system allows for a major reduction of contrast medium (70%) demonstrated in clinical study, enabling minimally invasive treatment of aortic aneurysms in a number of patients who are currently unable to benefit from minimally-invasive techniques.

Royal Philips announced the launch of VesselNavigator, its latest innovation in live 3D catheter navigation to guide the minimally invasive treatment of patients with vascular diseases such as aortic aneurysms, during the annual Charing Cross International Symposium (28 April – 1 May, London, UK).

This new catheter navigation solution, designed for use in conjunction with Philips’ interventional X-ray systems, enhances the precision and accuracy of stent placement, while at the same time significantly reducing contrast medium usage. As a result, minimally invasive treatment options will be available to patients previously unable to benefit from new image-guided intervention techniques, a press release from the company says.

Developed in collaboration with clinical partners such as the University Hospital Cologne (Germany) and the University Hospital Ghent (Belgium), VesselNavigator complements Philips’ current image-guided therapy portfolio within the field of endovascular and hybrid suite solutions. It addresses the need for advanced 3D live-image guidance solutions, as the treatment for vascular disease is experiencing a major transition from open surgery to minimally invasive procedures, with such procedure volumes growing at high single-digit rates.

VesselNavigator can be used for all types of endovascular procedures, but one of its key applications is guidance during the treatment of aortic aneurysms, which if left untreated could lead to severe complications such as massive internal bleeding.

VesselNavigator fuses live interventional X-ray images with pre-acquired 3D MRI or CT images of the patient’s vascular structures. The resulting 3D colour-coded images of the vessels provide enhanced real-time visual guidance, making it easier to manoeuvre through the vascular network without the need to enhance the X-ray visualisation with the repeated use of an injected contrast medium. In recent studies, VesselNavigator has been shown to reduce contrast medium usage by 70% and procedure times by 18%, contributing to more patient friendly, more efficient and more cost-effective treatment of vascular conditions.

VesselNavigator joins Philips’ extensive portfolio of live, 3D image-guided navigation solutions for image-guided minimally invasive therapies. This portfolio includes EmboGuide to support tumour embolization in cancer treatment.

Yasuaki Arai, director of the National Cancer Center Hospital, Tokyo, Japan, and current president of the Japanese Society of Interventional Radiology (JSIR), delivered the Honorary Lecture at the European Conference of Interventional Oncology (ECIO) in Nice, France, yesterday. He spoke on the topic “Beyond the evidence—the true goal of interventional oncology” and received a standing ovation for his presentation.

Quoting William Osler, a Canadian scientist who said that medicine is a science of uncertainty and the art of probability, Arai noted that therapeutic decision was based on probability. “We cannot forsee the future. The only way that we can choose the most suitable treatment is to choose it based on probability, as determined from scientific data. Therefore, clinical decisions should be made based on the probability.

Evidence-based medicine is the global paradigm in medicine. In the evidence-based medicine world, a treatment established by evidence is the standard and we provide the standard treatment for patients. Evidence from clinical trials inform clinical practice, therefore evidence changes the world. However, “Interventional oncologists must look beyond the evidence to think of all the possible interventional oncology solutions that can be offered to patients. While we have to respect the evidence, we should rise to the challenge of offering better treatment for patients using our knowledge, technique and ideas. We must standardise interventional oncology procedures and use standard endpoints in oncology.”

Arai outlined situations, particularly such as the ones encountered with patients who have advanced disease where there is no treatment pathway based on the current evidence. He said that in these situations, interventional oncologists had an important role to play.

“Sometimes oncologists who are committed to the evidence, say to advanced cancer patients, ‘there is no recommended treated for you’. Medical oncologists often use a ‘same disease, same drug, same dose and same administration’ schedule. We are not medical oncologists, we are interventional oncologists and our tools are not drugs, but techniques, devices, knowledge and a spirit that responds to a challenge. [Thereby being able to tailor solutions to individual patient needs],” Arai said.

Showing a series of cases where interventional oncology treatments had resulted in positive outcomes for patients, he noted that: “There is no evidence for some of these treatments, yet taking on a challenge led to a successful results for patients. Evidence is important. However, we should know that it is not perfect and not enough to care for our patients. While respecting the evidence, we should endeavour to create better treatments for patients using interventional oncology with our knowledge, techniques and ideas. We should move beyond the evidence,” he said.

Arai also made the point that interventional oncology can help bring down the costs of cancer treatments. “Cost reduction is the most important global issue of medicine,” he reminded delegates.

Then, using the example of bland embolization with handmade particles, Arai said, “This technique can be provided in any economical situation. [Often] Better treatment is not that which is special and available just for a small number of rich patients, but one that can be used for a wide number of patients. Developing new treatmenst is important, but developing available treatments and optimising them so that they are available for more patients is more precious,” he concluded.

Teleflex will showcase a wide array of products for minimally invasive interventional applications at the 6th European Conference of Interventional Oncology (ECIO) in Nice, France, from 22–25 April 2015.

Teleflex will present a wide array of products for minimally invasive interventional applications from its Arrow product line that are designed to enhance performance in interventional access and peripheral vascular procedures. These include peripherally inserted catheters, highly kink-resistant sheath introducers and a broad technology platform that is defining the field of intraosseous (inside the bone) medicine.

Current applications include vascular access, emergency and disaster medicine, oncology and spinal surgery.

The key product of focus will be the Arrow OnControl Power Driver. Using patented technology, this device provides interventional radiologists and oncologists a faster, more reliable solution for accessing dense and hard-to-reach bone lesions. The Arrow OnControl Bone Lesion Biopsy Tray contains all the instruments needed for multiple, high-quality bone lesion biopsies, from a single cortical penetration.

In experienced hands, non-target embolization is rare, a study presented at the European Congress of Radiology (ECR, 4–8 March, Vienna, Austria) concluded.

Portal vein embolization is a well-established technique to introduce hypertrophy of the future liver remnant in patients, scheduled to undergo extended hemihepatectomy. The most common embolization material used for portal vein embolization is usually Histoacryl/Lipiodol in either a ratio of 1:3 or 1:4 and coils.

Christina Loberg, Aachen, Germany, who presented the study said: “Histoacryl is an inexpensive and reliable embolizing agent, but it is difficult to control. So, when it is used, a contralateral approach is usually chosen to avoid non-target embolization. However, a puncture route through the contralateral lobe in the future liver remnant, has its own downsides. We therefore evaluated the safety of Histoacryl-based portal vein embolization from the ipsilateral approach.”

The investigators evaluated data from a total 107 portal vein embolization cases (68 were male and 39 female, age 22–84 years) of the right portal system, performed via percutaneous transhepatic right-sided approach. The embolization procedures were carried out between January 2010 and July 2014.

The researchers embolized the right portal branches with a Histoacryl/Lipiodol mixture and recorded the success rates and rates of complications following ipsilateral Histoacryl-based portal vein embolization.

Results

Our technical success was 99.1% with successful portal vein embolization achieved. In 0.9% embolization was impossible because of extensive right tumour load and we could not establish appropriate access to the right portal system. Clinical success, defined as sufficient hypertrophy, was achieved in 88.7% of cases. Nearly 73% of patients finally underwent successful extended hemihepatectomy,” Loberg continued.

In less than 2% of patients, Histoacryl/Lipiodol dislocated into the main portal trunk and caused non-target embolization requiring anticoagulation with prolonged hospitalisation for 72 hours. In 98% of the cohort, right sided Histoacryl-based procedures were completed successfully without non-target embolization. “Nearly 3% of patients developed severe sepsis after the procedure” she said.

Loberg told Interventional News: “We compared the complications for portal vein embolization with Histoacryl to major cohorts in the published literature. Kodama et al showed data for 47 patients, with 11 procedures performed contralaterally and 36 ipsilaterally. The overall complication rate was 15%. Di Stefano et al carried out 188 procedures and all used the contralateral approach. In this group, the overall complication rate was 12.8%. In our case, all procedures were ipsilateral and the overall complication rate was 5.5%. With regard to transient liver failure, this was not reported by Kodama, it was 3.2 % in the di Stefano group and 2.8% in our cohort. With regard to non-target embolization, in the Kodama et al cohort, it was 4.3%; in the di Stefano cohort, 5.3 % and in our cohort, 1.9%. Subcapsular hepatic haematoma occurred in 4.3% of cases in the Kodama cohort, 1.1% of the di Stefano cohort and 0% in our group. So, in comparison to these two other cohorts, our results show less complications in using the ipsilateral transhepatic right-sided approach,” she said.

A study presented at the Society of Interventional Radiology’s (SIR’s) 2015 annual scientific meeting reveals that a new angiographic imaging platform (AlluraClarity, Philips Healthcare) maintains similar procedure time as a current C-arm imaging platform (Allura, Philips), yet with substantially reduced radiation exposure for uterine artery embolization procedures. 

These findings have particular relevance for the many women undergoing uterine artery embolization who are of child-bearing age, as well as for the interventional radiology staff present in the room during the procedure.

Ruediger Egbert Schernthaner, a member of Jean-Francois Geschwind’s research team at the Johns Hopkins University, Baltimore, USA, set out to quantify the radiation exposure reduction of a new C-arm imaging platform for women with symptomatic uterine fibroids who were treated with uterine artery embolization.

In this ongoing prospective trial, twenty nine consecutive patients with symptomatic uterine fibroids were treated either on the new dose reduction imaging platform (n=15; AlluraClarity) or the reference imaging platform (n=14; Allura). X-ray dose logging was performed using a dedicated Radiation Dose Structured Reporting (RDSR) server.

The new system uses optimised acquisition parameters to lower the radiation exposure and real-time image processing algorithms such as noise reduction, temporal averaging and automatic pixel shift to restore the image quality.

Air kerma, the radiation exposure in free air before reaching the body, dose area product, the absorbed radiation dose multiplied by the area irradiated and acquisition time for digital fluoroscopy and digital subtraction angiography were recorded. The body mass index of patients was also noted. The unpaired t-test and Wilcoxon rank-sum tests were used to assess statistical differences between the platforms.

The investigators found that there was no difference in body mass index between the two patient cohorts. “Additionally, there was no significant difference in digital fluoroscopy or digital subtraction angiography time between the new and reference platforms, indicating that the procedure courses were similar between the two cohorts,” Schernthaner said.

 “Compared to the reference platform, the new platform significantly reduced the cumulative air kerma and dose area product by 57% and 66%, respectively (p<0.001 for both). Specifically, dose area product for digital fluoroscopy and digital subtraction angiography decreased by 39% (111.2 vs. 181.9 Gy*cm2, p=0.04) and 80% (65.5 vs. 320.5 Gy*cm2, p<0.001), respectively,” he reported. 

“The reduction of radiation exposure to only 20% of the standard system during digital subtraction angiography is especially important when considering that a number of interventional radiologists reported during the SIR meeting that they restrict the use of digital subtraction angiography in an attempt to lower the radiation exposure, but at the cost of an increased risk of non-target embolization,” Schernthaner explained. 

Schernthaner is a senior physician at the Medical University of Vienna, Vienna, Austria and a visiting scientist supported by the Max Kade Foundation at the Johns Hopkins University, Baltimore, USA.

Terumo has announced that on 16 March 2015 it received CE mark for LifePearl, a new drug-eluting microsphere for chemoembolization and HydroPearl, a new microsphere for more predictable bland embolization.

Terumo has developed these products in-house so that it can continue to provide its customers with a full range of interventional oncology products for access, ablation, embolics and microspheres, a press release from the company states.

For further information Terumo can be contacted at the European Congress of Interventional Oncology (ECIO, 22– 25 April, Nice, France) and the Global Embolization Symposium and Technologies (GEST, 24– 27 June 2015, Seville, Spain) conferences.

Medtronic has announced the initiation of the SPYRAL HTN global clinical trial programme, a phased clinical programme studying renal denervation in uncontrolled hypertension. This announcement follows investigational device exemption approval by the US Food and Drug Administration (FDA).

The programme will begin with two global studies designed to address the confounding factors encountered in the SYMPLICITY HTN-3 clinical trial, including medication, patient population and procedural variability, to ensure the clinical potential of the therapy is evaluated.

Physicians in both studies will perform renal denervation with Medtronic’s next-generation renal denervation technology, composed of the highly flexible 6Fr-compatible, multi-electrode Symplicity Spyral catheter and Symplicity G3 radiofrequency generator. The Symplicity Spyral catheter and G3 generator are investigational in the USA and Japan.

“Medtronic believes the underlying science behind renal denervation is strong and that there is a clear unmet need for people with uncontrolled hypertension. Therefore, we remain committed to exploring the clinical potential of renal denervation in this population,” said Jason Weidman, vice president and general manager, Medtronic Coronary and Renal Denervation, within Medtronic’s Coronary and Structural Heart business. “To get to this point, we have performed extensive analyses and conducted additional pre-clinical testing following the SYMPLICITY HTN-3 trial. We have also consulted with the FDA and reimbursement bodies, and partnered with renowned thought-leaders worldwide to develop this novel clinical trial protocol.”

The principal investigators for the initial two global studies represent some of the most experienced renal denervation specialists, including: Michael Böhm, chairman, Department of Internal Medicine, University of Saarland in Homburg/Saar, Germany; David Kandzari, director and chief scientific officer, Piedmont Heart Institute in Atlanta, USA; Kazuomi Kario, chairman, Department of Cardiovascular Medicine, Jichi Medical University School of Medicine in Tochigi, Japan; and Raymond Townsend, director of the hypertension programme, University of Pennsylvania, USA. 

The SPYRAL HTN programme includes two global, prospective, randomised, sham-controlled trials conducted simultaneously by experienced proceduralists to investigate the impact of renal denervation both in the absence of and in the presence of antihypertensive medications. The SPYRAL HTN-OFF MED and SPYRAL HTN-ON MED studies will each include approximately 100 patients with moderate- to high-risk hypertension, as opposed to the severe, treatment resistant population studied in the SYMPLCITY HTN-3 trial. These studies will be conducted at approximately 20 centres in the USA and other global geographies.

The SPYRAL HTN-OFF MED study is designed to isolate the effect of renal denervation on blood pressure reduction. Similar to the traditional design of antihypertensive pharmaceutical clinical trials, this approach was recommended by both the FDA and the global clinical community.

Separately, the SPYRAL HTN-ON MED study will evaluate the effect of renal denervation on blood pressure in the presence of antihypertensive medication. Unlike the SYMPLICITY HTN-3 trial, which enrolled patients with very high blood pressure that was not controlled despite an average of five antihypertensive medications at maximum tolerated dosages, the SPYRAL HTN-ON MED study requires patients who, despite use of drugs from three of the most common classes of medications prescribed for hypertension, do not achieve adequate blood pressure control. These drugs are not required to be prescribed at maximum tolerated medication dosages, a factor which may have contributed to variability in patient adherence and the large number of medication changes during the SYMPLICITY HTN-3 trial. Additionally, patient medication adherence will be closely monitored and there will be a focus on ambulatory blood pressure monitoring to ensure consistency between both arms of the on- and off-medication studies. 

“Studying patients both on and off medication in a less severe and more homogenous population than we saw in the SYMPLICITY HTN-3 trial is critical to gaining clarity on the true effect of this therapy,” said Townsend. “By specifying medication classes and not requiring maximum tolerated doses, we can expect medication variability to be reduced, which will allow for a more controlled assessment of the impact of renal denervation in the presence of medication.”

Based on the outcomes of these two initial studies of the SPYRAL HTN programme, Medtronic will evaluate next steps for a pivotal study to support a pre-market application submission to the FDA and Shonin submission in Japan.

“With this clinical programme, Medtronic continues to make significant contributions to the field of renal denervation,” Böhm added. “Not only will these data add to the scientific basis for renal denervation at large, but if we see positive outcomes, it will help reinforce what many physicians have experienced in their practice, and will provide even more confidence to support continued use of the therapy in geographies where the technology is currently available.”

BTG has expanded its commercial presence in Europe in recent months by building an expert sales force to promote the approved uses of its products in major European markets. This team has been selling BTG’s radioembolization product TheraSphere and will also sell DC Bead and Bead Block, the company’s complementary interventional oncology products.

DC Bead is an embolic drug-eluting bead capable of loading and releasing chemotherapeutic agents for the treatment of hepatocellular carcinoma and liver metastases from colorectal and other cancers. Bead Block is an embolic device for embolizing blood vessels of a variety of hypervascularised tumours and arteriovenous malformations and is most commonly used for the treatment of uterine fibroids and other benign tumours.

John Sylvester, chief commercial officer for Interventional Medicine, BTG, said:  “We are pleased to be supplying our beads and Therasphere products directly to healthcare professionals in Europe.  BTG is investing in product innovation and clinical development to better serve specialist interventional oncology physicians. We are proud to be a leader in interventional medicine, moving medicines from major surgery to minor procedures and from the systemic to the local.”

DC Bead and Bead Block, developed and manufactured by BTG, both received CE mark approval in Europe in 2003. These products were previously sold in Europe by the Terumo Corporation under a contract that expired on 31 March 2015.  BTG will be selling directly to hospitals in Austria, Belgium, France, Germany, Ireland, Italy, Netherlands, Portugal, Switzerland, Spain, and the UK.

A press release from the company states that through the growth of its embolic bead products, the acquisitions of TheraSphere and EKOS Corporation, the US approval of Varithena, and the acquisition of interventional pulmonology company PneumRx earlier this year, BTG has become a leader in interventional medicine.

Forge Medical, manufacturer of the VasoStat haemostasis device that is used for radial artery and dialysis access haemostasis, announced that the company has entered into a national commercialisation agreement for the device with National Medical Sales.

Timothy WI Clark, cofounder and CEO of Forge Medical, said: “Transradial interventions are now commonly performed by interventional cardiologists, interventional radiologists, and vascular surgeons. As radial access continues to be rapidly adopted by endovascular physicians, clinicians demand an effective solution for puncture-site management with patent haemostasis. With the increasing data supporting the safety and superiority of transradial access over traditional transfemoral access, we are proud to provide a unique and innovative haemostasis device to meet this need.”

Clark is associate professor of Clinical Radiology at the University of Pennsylvania Perelman School of Medicine, Division of Interventional Radiology, Department of Radiology, and is the director of Interventional Radiology at Penn Presbyterian Medical Center in Philadelphia, USA.

Forge Medical will be exhibiting VasoStat at the 2015 TransRadial Endovascular Advanced Therapies in New York, USA, on 24 April 2015. The symposium is sponsored by the Icahn School of Medicine at Mount Sinai and will be held at the Leon and Norma Hess Center for Science and Medicine in New York, USA.

“We are excited to participate in the TREAT Symposium, the first of its kind geared toward interventional radiology and vascular surgery,” Clark said.

A study from France presented at the European Congress of Radiology (ECR, 4–8 March, Vienna, Austria) has found that percutaneous thermal ablation is safe and effective for local control of metastatic breast cancer.

Investigators Matthias Barral, Department of Interventional Radiology, Institut Gustave Roussy, Villejuif, France, told delegates that in the researchers’ opinion, ablation was likely to play a major role in future treatment strategies in association with other therapies for patients with few metastatic lesions.

The researchers set out to describe the prognostic factors for the local control rate and the one- and two-year disease-free survival after percutaneous thermal ablation in patients with oligometastatic breast cancer>

Barral told Interventional News: “Treatment of oligometastatic breast cancer (less than five metastases) is currently highly challenging. Although this condition concerns just a small proportion of metastatic patients, due to refinements in new systemic chemotherapy along with specific hormonal therapy, a wider range of patients are prone to becoming oligometastatic after completion of their medical treatment. Surgery and stereotactic body radiation therapy have demonstrated their efficicacy for local ablation of breast cancer metastases and each has their own advantages and drawbacks. Regarding interventional radiology, researchers have already demonstrated that radiofrequency ablation of breast cancer liver metastases is safe and efficient for tumours smaller than 3cm with a success rate of about 90%. Recently, interventional radiology has developed a therapeutic armamentarium including microwave ablation and cryotherapy that allows increasing the possibilities of ablation to lung, bone or even to soft tissue metastases.

“The primary goal of our study was to demonstrate that interventional radiology along with systemic chemotherapy is able to manage oligometastatic breast cancer regardless of the location of the metastases. In addition, breast cancer is a very heterogeneous disease considering its histological subtype, immunological profile, progression rate, etc. Consequently, there is a need for interventional radiologists to be aware of the potential factors that might be associated with a poorer outcome in terms of local relapse or disease-free survival. As a matter of fact, the role of the interventional radiologist in the management of oligometastatic patients should not be limited to the assessment of the technical feasibility of an image-guided percutaneous ablation, it should also include the knowledge of breast cancer variety and natural history that might influence the treatment decision. With this knowledge in hand, interventional radiologist could therefore become a major player in the multidisciplinary management of oligometastatic breast cancer patients.”

The Villjeuf researchers treated nearly 80 patients with 114 breast cancer metastases involving bones, liver and lung, with a mean diameter of 28.9±16.1 mm [5–86mm] using thermal ablation only with a curative intent for all metastases.

Barral and colleagues evaluated the following prognostic factors: histological subtype, interval between diagnosis of breast cancer and ablation, diameter of each metastases at the time of treatment, sum of maximal diameter of all metastases, number of metastases, context of occurrence (synchronous, relapse after complete remission or incomplete response to systemic chemotherapy), progression despite systemic therapy and targeted organ.

“We evaluated local relapse and the one- and two-year disease-free survival on cross-sectional imaging according to the increasing in the diameter of the ablation scars, the onset of enhancement on the ablation scars and to the onset of a new metastases, respectively,” he explained.

The median follow-up was 18.4 months.

Results from the study showed that the local control rate at one and two years was 84.1% and 77.1%. Larger diameters of the metastases treated were associated with an incomplete local treatment (p=0.034). The one- and two-year disease-free survival rates were 55.4% and 31.1%. Triple negative breast cancer metastases, ie those that do not express the genes for oestrogen receptor, progesterone receptor or Her2/neu making chemotherapy more difficult, were associated with a poorer outcome. “There was no post-treatment mortality and the morbidity rate was 15% with none of the complications requiring surgical intervention,” said Barral.

The study was presented at the Society of Interventional Radiology’s annual scientific meeting (28 February–5 Atlanta, USA). Aaron Fischman, Department of Interventional Radiology, Icahn School of Medicine at Mount Sinai, New York, USA, spoke to Interventional News.

“About three years ago, we had not carried out any cases using the transradial approach. In cardiology, there is a vast body of literature regarding this access route. Nearly every paper that has been written on radial access has a signal that it is superior to femoral access with regard to bleeding rates, patient satisfaction, safety and complications so we have been trying to parse out which parts of interventional radiology that could translate to. For me, the benefits of transradial access fit into interventional radiology’s mission to provide the least invasive, most cost-effective and highest quality care and that is why I am interested in it,” he said.

Fischman and colleagues note that transradial access has been shown to decrease complications when compared with transfemoral access in coronary intervention. Transradial access for peripheral and visceral interventions is less common but has been reported to offer comparable therapeutic efficacy as transfemoral access in chemoembolization with lower overall access-site complications. Additionally, the lack of need for an arterial closure device in transradial access affords patients faster time to ambulation and discharge.

The investigators retrospectively reviewed 1004 procedures performed in 668 patients undergoing transradial access from April 2012 to October 2014. Procedures included: chemoembolization (n=371), Y90 mapping (n=249) and infusion (n=168), renal/visceral intervention (n=104), uterine artery embolization (n=65), peripheral intervention (n=37), endoleak (n=8), and other (n=2).

The authors noted that a pulse oximeter was used on the ipsilateral thumb to confirm dual circulation and patency of the palmar arch (Barbeau Test). They further noted that ultrasound of the radial artery verified adequate vessel size. Transradial access contraindications included: radial artery <2mm and Barbeau D waveform. After radial artery puncture, a hydrophilic radial access sheath (Glidesheath,Terumo Interventional Systems) was placed and 3000U heparin, 2.5mg verapamil, and 200mcg nitroglycerin was given to minimise vascular trauma. Following the procedure, a radial compression device, TR band (Terumo) was used for haemostasis. Procedural details and 30-day adverse events were evaluated using CTCAE v4.0.

The researchers reported that there was 99.4% (998/1004) technical success obtained via transradial access, with six cases requiring transfemoral access crossover (0.6%). Overall major adverse events were 0.3% including one large haematoma requiring crossover to transfemoral access, one pseudoaneurysm requiring intervention, and one verapamil-induced seizure. The minor adverse event rate was 3.2% and included radial artery occlusion (n=11, three crossover), haematoma/bleeding (n=9), radial artery thrombosis (n=five, one crossover), arteritis (n=three), pain/numbness (n=two), and severe vasospasm (n=two, one crossover). “All minor adverse events were either asymptomatic or managed conservatively. There were no additional adverse events at 30 days,” the authors wrote.

Different patient experience

Fischman emphasised that from a patient’s point of view, the transradial approach is very different from the transfemoral approach. “Quite often patients can have sensitivity in the groin, and some do not like being exposed in that area. The femoral artery is deeper [than the radial artery] so there can be more pain with femoral access. We have learned that the approach from the wrist is perceived by patients as less invasive and less painful. Patients do not have to keep their leg flat for three hours and can literally walk out of the room. They can also recover sitting in a chair, rather than on a hospital bed. 

“When I was trained, I did not think about the access route, we used the femoral route and that was it. Now, we think about which access site is most suitable technically for the procedure and for the individual patient. In morbidly obese patients, for example, the transradial approach is significantly easier and safer. The adoption of the transradial approach in interventional radiology is very low. In many countries, nearly 80 to 90% of percutaneous coronary intervention is via the transradial approach. We want to teach people how to do this and what we have learned as there is some nuance to this,” he said.

Tools needed

Currently, medical devices are not optimised for transradial access. “We are collaborating with industry to design a specific interventional radiology approach for transradial access. We need many types of devices that are not optimised; three that would be helpful right away are: longer catheters with different shapes; stents; and balloons,” Fischman said.

Giovanni Mauri, Milan, Italy, reported the results of the study on the treatment of benign biliary strictures with a novel bioresorbable biliary stent, EllaDV (Ellacs) at the European Congress of Radiology (ECR, 4–8 March, Vienna, Austria).

Mauri told Interventional News: “Bioresorbable biliary stents are important because they offer an additional treatment option for patients in whom standard treatments (bilioplasty or sustained dilation) have failed, potentially sparing a surgical re-operation. Degradation of the stent occurs by hydrolysis in about six months and the radial strength is reduced by 50% in about six to eight weeks.”

Biliary strictures represent a frequent complication of surgical procedures involving the biliary tract. In order to avoid the invasiveness of a re-operation, endoscopical and percutaneous treatments are generally used as a first option. When endoscopy is not feasible, percutaneous strategies remain the only non-surgical option for repair. However, with this strategy, stricture recurrences are fairly frequent, and patients have to carry an external drain for a long period (often several months).

Mauri said: “Implantation of a stent at the level of the stenosis offers the advantage of a sustained dilation effect with a higher expansion force compared to bilioplasty and biliary drainage. Successful attempts have been made with the use of retrievable covered metal stents in the treatment of benign biliary stenosis. However, as the access to the biliary tree has to be maintained for subsequent removal of the stent, even when retrievable stents are used, the patient has to carry an external drain for a long period. Bioresorbable biliary stents seem to offer an advantage in stenting, avoiding the problems related with subsequent stent removal, and with the advantage of an early completion of the whole procedure. After bioresorbable stent implantation, external drainage is kept in place for about 24 or 48 hours. For this reason we think that implantation of a bioresorbable in the future may be considered not only an effective option when other strategies have failed, but could also be used as an alternative first option in order to spare the patient the discomfort of a long-period external drainage.”

The investigators, from 10 centres experienced in percutaneous treatment of biliary disease, retrospectively evaluated data from 59 patients (35 [59.3%] males, age 56.8 ± 18.9 years) who were treated with the bioabsorbable EllaDV stent (n=67) to treat benign biliary strictures refractory to standard bilioplasty. They evaluated the technical success (correct implantation of the stent as preoperatively planned), clinical effectiveness (resolution of the clinical problem), immediate or late complications, and rate of restenosis at follow-up.

Mauri and colleagues observed that the procedure was successfully performed in 58/59 patients (technical success 98.3%). In one case, a malpositioning of the stent during the procedure occurred.

“The procedure was also clinically effective in all cases. There were four (6.8%) immediate complications, including malpositioning and three mild haemobilia that resolved spontaneously. No late complications related to the stent positioning occurred. At a mean follow-up time of 23.2 ± 15.1 months (mean ± standard deviation), there were 11 (18.6%) cases of restenosis, with a mean time to restenosis of 16.2 ± 8.2 months (mean ± standard deviation),” said Mauri.

In the first-line treatment of non-resectable metastatic colorectal cancer, the preliminary analysis of the SIRFLOX study results does not show a statistically significant improvement in overall progression-free survival ie, at any site. However, the study does show a statistically significant improvement in progression-free survival in the liver.

A press release from Sirtex states that the data will be submitted for peer review to the American Society of Clinical Oncology (ASCO) 2015 annual meeting (29 May– 2 June, Chicago, USA).

Based on the preliminary analysis just completed, the primary endpoint of the SIRFLOX study was not achieved. The preliminary analysis shows that adding SIR-Spheres Y-90 resin microspheres to a current first-line systemic chemotherapy regimen for the treatment of non-resectable metastatic colorectal cancer does not result in a statistically significant improvement in the overall progression-free survival. Overall progression free survival measures progression of existing tumours and/or the development of new tumours in any organ or body site.

The release adds that Sirtex is pleased that the preliminary analysis showed that SIR-Spheres Y-90 resin microspheres did result in a statistically significant improvement in progression-free survival in the liver. This secondary study endpoint is important as liver tumours are commonly the only, or dominant, site of disease in patients with metastatic colorectal cancer and are the major site of disease influencing survival. Up to 90% of these patients die of liver failure due to the local effects of the liver tumours. SIR-Spheres Y-90 resin microspheres are specifically targeted to treat liver tumours.

As previously advised (most recently on 9 October 2014), the SIRFLOX study results and preliminary analysis still require verification and validation through the process of academic peer review. Presentation at a scientific conference and/or publication in a medical journal are essential parts of this process.

CE mark has been awarded to the new rotating thumbwheel deployment system for Cook Medical’s Zilver PTX drug-eluting peripheral stent. The new system, which is now available for purchase in the UK, Ireland, Germany, Spain and Italy, provides simple deployment for what Cook Medical says is the world’s first and only approved drug-eluting stent for the superficial femoral artery.

“Our objective when designing the new handle was to improve accuracy and deliverability on the previous pin-and-pull system,” said Lindsay Koren, global product manager for stent development. “We have not only succeeded in our engineering and production goals, but have surpassed many of our expectations for several of the new features.”

The thumbwheel design features include an ergonomic handle that facilitates single-handed deployment. In addition to the new deployment system, 120mm length Zilver PTX stents are also now available while all lengths on the new delivery system are now CE marked with a 24-month shelf life.

Andrew Holden, director of interventional services at Auckland City Hospital and associate professor of radiology at Auckland University School of Medicine in New Zealand, is a Cook Medical consultant and the first physician in the world to use the new deployment system in his practice.

“Based on my own experience, I have found that Cook’s new Zilver PTX deployment system has overcome the challenges associated with the previous system,” he said. “The new thumbwheel system allows for greater control and accuracy making it significantly easier for me to deploy the Zilver PTX stent.”

Bracco Imaging, through its business unit Bracco Injeneering SA, has announced the availability of its EmpowerCTA+, an advanced engineering contrast injection system that puts the radiologic technologist in control in the computed tomography suite.

The EmpowerCTA+ was first launched in the USA, then gradually in Europe, and was presented at the European Congress of Radiology (ECR, Vienna, 4–8 March 2015).

The EmpowerCTA+ contrast injection system has been reengineered, setting a new standard in the contrast power injectors market. The system was designed to streamline workflow, with enhanced safety and control at the patient side.

EmpowerCTA+ ‘s advanced touchscreen technology enables technologists to customise the contrast injection experience right at the patient’s side with new enhancements, including real time variable flow rates, saline advance, and saline jump.

“We are extremely pleased to announce the availability on the market of the EmpowerCTA+,“ said Vittorio Puppo, head of business unit injectors and president and CEO at Bracco Diagnostics. “The contrast injector system was reengineered with digital touch technology and a new visionary design with high performance, which will help us to increase market penetration.”

EmpowerCTA+ has a saline advance function which tests a patient’s patency and vein integrity while its saline jump feature minimizes the amount of contrast a patient receives. The injector’s unique patented EDA™ (extravasation detection accessory) advances patient care while providing additional safety and peace of mind for the technologist. In addition, its eGFR calculator simplifies calculations for kidney evaluation function prior to contrast delivery. The risk of air embolisms to the patient is reduced due to the system’s built-in tilt sensor and lock. Technologists have greater control with the touchscreen technology at the patient’s side.

Early data from a multicentre, single-arm study that set out to evaluate the safety and effectiveness of a novel approach to inferior vena cava filtration using the VenaTech convertible filter (B Braun Interventional Systems) suggest that the use of this device yields favourable results.

Eric J Hohenwalter, Department of Radiology, Medical College of Wisconsin, USA, presented the research at the Society of Interventional Radiology’s (SIR’s) Annual Scientific Meeting (28 February–5 March, Atlanta, USA). This paper was one of two classified as “abstracts of the year” at the conference.

The VenaTech convertible filter can be converted into a stent configuration (to be left in the inferior vena cava) after the temporary need for a filter to prevent pulmonary embolism has passed. It has a hook and locking mechanism at the filter head and anchoring hooks for filter attachment to the vena cava wall. These encourage endothelialisation of the legs into the vessel wall. It also has self-centring stabilising legs. Its design is based on permanent filters, which may translate to fewer long-term filter complications compared to long-term use of retrievable filters, said Hohenwalter.

“The inferior vena cava is a thin-walled dynamic structure. All current retrievable filter designs have minimal contact points with the caval wall which could be stress points. The benefit of a filter is greatest during the acute period of venous thromboembolism risk and diminishes over time in most patients. Most retrievable filters remain in place after the period of risk has passed,” explained Hohenwalter.

The primary objective of the study was to determine whether the rate of successful filter conversion was no lower than reported retrieval success rate. The secondary objectives were to estimate the six-month major device-related adverse event rate in patients with a converted filter and to determine the device deployment success rate. The results were evaluated by an independent core lab.

“This study showed that the conversion rates are favourable compared to published retrieval rates. The early results show no inferior vena cava perforation vs. current retrievable filter designs,” Hohenwalter reported.

Patients were included if they had a time-limited risk of pulmonary embolism. They had to have a filter indicated because anticoagulants were contraindicated, or if they had experienced failure of anticoagulation. Patients could also be included if they needed emergency treatment following massive pulmonary embolism. Their inferior vena cava diameter needed to have been less than or equal to 28mm as evaluated by contrast venography and corrected for magnification.

“Nearly 150 patients have been enrolled at 11 sites. Eighty filters have been converted, of which just over 60 have been followed for a minimum of six months post-conversion. There have been 25 “permanent” filters followed for a minimum of six months,” he noted.

Hohenwalter told delegates: “All the filters were deployed successfully with a median time of 12.5 minutes, and there were no complications. There were 83 filter conversion attempts and 80 conversions to date. There were 77 “successful” conversions based on the protocol definition. There was a 93% technical success rate. There were six technical complications associated with the conversion procedures; three instances of being unable to snare the filter hook and three instances of incomplete opening of filter legs, following conversion. The median number of days to filter conversion was 122 (range 15–231).”

With regard to reported technical complications, there were 13 in total including one early filter migration. There were no reports of filters being deployed in unintended positions, extravascular perforation of the inferior vena cava, filter fracture, inadequate distribution or incomplete opening of the filter legs, or spontaneous conversion.

There were nine device-related serious adverse events in 2% of the study participants (3/148). These included caval thrombosis/occlusion, compromise of cardiac valve function due to filter embolization and deep vein thrombosis. There were no instances of perforation of the inferior vena cava and/or adjacent organs or vertebral bodies.

Hohenwalter noted that with the convertible filters, the conversion itself was largely classified as easy by physicians performing the procedure. Most procedures used accessory devices and the procedure was still seen as straightforward with no complications.

“With convertible filters, what is left behind is an inferior vena cava stent, and there is no inferior vena caval perforation seen in this study due to the stent. In the case of retrievable filters, the filter is designed to be removed. However, many are left behind and can result in inferior vena cava perforation and adjacent organ damage,” said Hohenwalter.

SARAH, a large French study of patients with advanced, inoperable hepatocellular carcinoma (HCC) has completed patient enrolment, exceeding its 400-patient target, according to its principal investigator, Valérie Vilgrain, department of radiology, Beaujon Hospital, Assistance Publique–Hôpitaux de Paris (AP-HP) and Université Paris Diderot, Sorbonne Paris Cité, France.

SARAH (sorafenib versus radioembolization in advanced hepatocellular carcinoma) is a phase III multi-centre randomised controlled study, sponsored by the AP-HP, directly compares the efficacy of selective internal radiation therapy (SIRT, or radioembolization) using yttrium-90 (Y-90) resin microspheres (SIR-Spheres Y-90 resin microspheres; Sirtex Medical Limited) versus sorafenib (Nexavar; Bayer HealthCare), a systemic therapy that is the current standard of care for patients with inoperable advanced HCC.

“SARAH is the largest randomised study ever to compare selective internal radiation therapy—or any liver-directed therapy—against the standard-of-care systemic therapy in the treatment of primary liver cancer. The SARAH study team is delighted that enrolment is now complete, with results expected in late 2016,” Vilgrain said.

SARAH is for patients in France with advanced HCC (Barcelona clinic liver cancer stage C) with or without portal vein thrombosis and no extrahepatic spread, or whose disease has progressed or recurred after previous therapies; and who are ineligible for surgical resection, ablation or liver transplantation. The study is also comparing the quality of life of patients and other measures such as the tolerability of the treatments.

Coordinated by Vilgrain, more than 25 specialist cancer centres throughout France are involved in the study. SIR-Spheres Y-90 resin microspheres were selected for the test arm of this independent, collaborative national study. “Target enrolment was reached in around three years, which is remarkable for a single-country trial of this size in a hard-to-treat cancer with few proven therapeutic choices,” Vilgrain noted.

Sorafenib was established as the standard treatment for patients with advanced HCC following the results of the pivotal SHARP randomised controlled trial, which demonstrated an increased median overall survival from eight to 11 months compared to placebo. However, 80% of patients receiving sorafenib also experienced treatment-related adverse events.

SIRT with SIR-Spheres Y-90 resin microspheres is an approved treatment for inoperable liver tumours. It is a minimally invasive treatment that delivers high doses of high-energy beta radiation directly to the tumours via a catheter into the liver arteries that supply blood to the tumours. By using the tumours’ blood supply, the microspheres selectively target liver tumours with a dose of radiation that is up to 40 times higher than conventional radiotherapy, while sparing healthy tissue.

Interest in a randomised controlled study of SIRT using Y-90 resin microspheres in this patient population was based on a substantial number of open-label single-group studies as well as a large multi-centre European study on the long-term outcomes related to survival and safety of SIR-Spheres Y-90 resin microspheres in patients with inoperable HCC. In 13 open-label single-group studies with a total of 400 patients with advanced HCC, the combined estimation of the median overall survival after radioembolization with Y-90 microspheres was 15 months, with a range of 7–27 months.

SIR-Spheres Y-90 resin microspheres are approved for the treatment of inoperable liver tumours in Australia, the European Union (CE mark), Argentina (ANMAT), Brazil, and several countries in Asia, such as India and Singapore. SIR-Spheres Y-90 resin microspheres also have a full Pre-Market Approval from the US Food and Drug Administration and are indicated in the USA for the treatment of non-resectable metastatic liver tumours from primary colorectal cancer in combination with intra-hepatic artery chemotherapy using floxuridine.

Atlanta will play host to the launch of a unique new resource to support families affected by primary liver cancer. Medikidz Explain Primary Liver Cancer will be introduced at this year’s Society of Interventional Radiology Annual Scientific Meeting (28 February–5 March) and the Association of Radiologic and Imaging Nursing Spring Conference at the Georgia World Congress Center in Atlanta (1–2 March).

The launch event will feature the Medikidz superheroes to help raise awareness amongst clinicians about the new resource to educate young people about this complicated disease. The comic will be available free of charge for healthcare professionals in the USA through the BTG team, to be given to patients with primary liver cancer who may be struggling to explain the condition to their loved ones. “This non-threatening approach to education for children is a fantastic new tool to support primary liver cancer patients and their families in difficult conversations outside of the clinic and hospital”, explains Greg Laukhuf – 2014-2015 ARIN president.

Medikidz, the medical education company specifically for children, working in partnership with BTG Interventional Medicine, has published “Medikidz Explain Primary Liver Cancer” to help children understand and cope with the realities of life during what is often a very challenging time.

The Medikidz Explain Primary Liver Cancer comic is authored by doctors and reviewed by leading specialists as well as families living with the experience of primary liver cancer. The comic book uses a unique approach to present information to young people in an engaging way, thus ensuring that medical information is presented in simple terms that they can understand, while at the same time maintaining medical accuracy.

Sponsored by BTG Interventional Medicine, endorsed by the Society of Interventional Radiology, the Association for Radiologic & Imaging Nursing, the British Society of Interventional Radiology, and with content support from the British Liver Trust, Medikidz Explain Primary Liver Cancer is a unique, child-friendly exploration of what happens inside the body of patients with the condition.

Co-founder of Medikidz, Kate Hersov, explains: “Medikidz was founded out of a frustration with the lack of child-friendly health information available. We work closely with healthcare professionals, professional bodies, families and children to fully understand the needs of young people. Thanks to the book’s sponsor, BTG, and to the Society of Interventional Radiology, Association for Radiologic & Imaging Nursing, British Society of Interventional Radiology and British Liver Trust, we will be able to help children better understand the situation during a time of anxiety, confusion and emotional stress.”

3D printing could become a powerful tool in customising interventional radiology treatments to individual patient needs, with clinicians having the ability to construct devices to a specific size and shape, according to a study being presented at the Society of Interventional Radiology’s Annual Scientific Meeting (28 February–5 March, Atlanta, USA). Researchers and engineers collaborated to print catheters, stents and filaments that were bioactive, giving these devices the ability to deliver antibiotics and chemotherapeutic medications to a targeted area in cell cultures.

“3D printing allows for tailor-made materials for personalised medicine,” said Horacio R D’Agostino, lead researcher and an interventional radiologist at Louisiana State University Health Sciences Center (LSUH) in Shreveport, USA. “It gives us the ability to construct devices that meet patients’ needs, from their unique anatomy to specific medicine requirements. And as tools in interventional radiology, these devices are part of treatment options that are less invasive than traditional surgery,” he added.

Using 3D printing technology and resorbable bioplastics, D’Agostino and his team of biomedical engineers and nanosystem engineers at LSUH and Louisiana Tech University developed bioactive filaments, chemotherapy beads, and catheters and stents containing antibiotics or chemotherapeutic agents. The team then tested these devices in cell cultures to see if they could inhibit growth of bacteria and cancer cells.

When testing antibiotic-containing catheters that could slowly release the drug, D’Agostino’s team found that the devices inhibited bacterial growth. Researchers also saw that filaments carrying chemotherapeutic agents were able to inhibit the growth of cancer cells.

“We treat a wide variety of patients and, with some patients, the current one-size-fits-all devices are not an option,” added D’Agostino. “3D printing gives us the ability to craft devices that are better suited for certain patient populations that are traditionally tough to treat, such as children and the obese, who have different anatomy. There is limitless potential to be explored with this technology,” he noted.

The research team is also able to print biodegradable filaments, catheters and stents that contain antibiotics and chemotherapeutic agents. These types of devices may help patients avoid the need to undergo a second procedure or treatment when conventional materials are used.

D’Agostino believes that this early success with 3D-printed instruments in the lab warrants further studies, with the goal of receiving approval to use these devices in humans. D’Agostino also sees an opportunity to collaborate with other medical specialties to deliver higher-quality, personalised care to all types of patients.

Patients suffering from chronic plantar fasciitis now have a new treatment option against this debilitating foot ailment, according to research presented at the Society of Interventional Radiology’s annual scientific meeting. 

Researchers used ultrasound imaging and specific ultrasonic energy to penetrate, emulsify and remove diseased fasciitis tissue. Permanently removing damaged, pain-generating tissue allowed room for healthy tissue to regrow in its place, restoring normal function.

“Plantar fasciitis is so ubiquitous and such a difficult condition to live with, and yet patients have been limited in their treatment options,” said Rahul Razdan, one of the study’s researchers and an interventional radiologist at Advanced Medical Imaging, Lincoln, USA. “While standard treatments, such as pain medication and physical therapy, can offer some relief, there have been no permanent answers. Consequently, safe and effective definitive treatments are highly desirable,” he noted.

In the study, 100 patients were treated, beginning in August 2013. The patients presented with chronic, refractory plantar fasciopathy, and all patients had previously failed to respond to medications, activity modification and arch supports. Before treatment, patients reported how their foot pain affected their ability to manage everyday life through the Foot and Ankle Disability Index (FADI). FADI scores were collected from the patients at two weeks, six weeks and six months post treatment.

Two weeks after treatment, more than 90% of patients reported improvement in symptoms, and these improvements were maintained at six months. Patients also reported being highly satisfied with the treatment and had no treatment-related complications.

“It is important for patients suffering from chronic plantar fasciitis to know that they have treatment options,” added Razdan. “We have patients who are in so much pain they cannot even play with their kids or take their dog for a walk. This ultrasonic treatment can give patients their lives back and let them enjoy their lives. We are excited to see significant results from this treatment,” he said.

Chronic plantar fasciitis is the most common debilitating foot complaint, affecting approximately 10% of the population and accounting for more than one million office visits annually, said Razdan.

According to research presented at the Society of Interventional Radiology’s (SIR’s) annual scientific meeting, clinicians were able to use prostate artery embolization to improve patient symptoms, regardless of the size of benign prostatic hyperplasia before the treatment, researchers found in a retrospective study.

Sandeep Bagla, the study’s lead researcher and an interventional radiologist at Inova Alexandria Hospital, Alexandria, USA said: “This innovative treatment offers less risk, less pain and less recovery time than traditional surgery, and we are hopeful that further research will confirm it to be an effective therapy for benign prostatic hyperplasia.”

Bagla and his team examined the cases of 78 patients who underwent prostate artery embolization for benign prostatic hyperplasia as part of the clinicians’ routine practice. Patients were categorised into three different analysis groups based on the size of the enlarged prostate: less than 50 cubic centimetres, between 50 and 80 cubic centimetres and greater than 80 cubic centimetres. The researchers evaluated the effectiveness of prostate artery embolization in these patients at one, three and six months post treatment.

Ninety-six per cent of cases (75 of 78) were considered technically successful, with both blood vessels leading to the enlarged prostate blocked by treatment. The researchers found symptom improvement and that quality of life, as measured by the American Urological Association Symptom Index, significantly improved in all three patient groups. When comparing each group, there was no difference in outcome as well. Using the International Index of Erectile Function, patients also did not report a change in their sexual function. Bagla attributes this low rate of side-effects to the fact that prostate artery embolization is conducted via the femoral artery versus other treatments, which enter through the urethra or penis.

“Many men have benign prostatic hyperplasia that cannot be treated by traditional methods, such as when the benign prostate artery is smaller than 50 cubic centimetres or larger than 80 cubic centimetres,” said Bagla. “Prostate artery embolization offers these patients an effective treatment that results in reduced risk of bleeding, urinary incontinence or impotence, compared to other therapies, offering patients a better quality of life,” he added.

While the data from this research demonstrate continued symptomatic improvement six months after treatment, more research is needed to show efficacy at one year and beyond, added Bagla. He also believes that additional research—possibly randomised, prospective studies—should be done to compare the safety and efficacy of prostate artery embolization with other commonly performed benign prostatic hyperplasia treatments.

“As healthcare moves toward more patient-centred care, it is critical that interventional radiologists, in collaboration with urologists, are able to provide benign prostatic hyperplasia patients with a relatively painless, outpatient procedure,” he added.

An innovative interventional radiology treatment has been found to offer chronic migraine sufferers sustained relief of their headaches, according to research being presented at the Society of Interventional Radiology’s Annual Scientific Meeting (28 February–5 Atlanta, USA).

Clinicians at Albany Medical Center and the State University New York Empire State College in Saratoga Springs used image-guided, intranasal sphenopalatine ganglion blocks to give patients enough ongoing relief that they required less medication to relieve migraine pain.

“Migraine headaches are one of the most common, debilitating diseases in the USA, and the cost and side-effects of medicine to address migraines can be overwhelming,” said Kenneth Mandato, the study’s lead researcher and an interventional radiologist at Albany Medical Center. “Intranasal sphenopalatine ganglion blocks are image-guide, targeted, breakthrough treatments. They offer a patient-centred therapy that has the potential to break the migraine cycle and quickly improve patients’ quality of life,” he added.

Mandato and his team conducted a retrospective analysis of 112 patients suffering migraine or cluster headaches. Patients reported the severity of their headaches on a visual analogue scale (VAS), ranging from 1 to 10, to quantify the degree of debilitation experienced from the migraine. During the treatment, which is minimally invasive and does not involve needles touching the patient, researchers inserted a spaghetti-sized catheter through the nasal passages and administered 4% lidocaine to the sphenopalatine ganglion, a nerve bundle just behind the nose associated with migraines.

Before treatment, patients reported an average VAS score of 8.25, with scores greater than 4 at least 15 days per month. The day after the block patients’ VAS scores were cut in half, to an average of 4.10. Thirty days after the procedure, patients reported an average score of 5.25, a 36% decrease from pre-treatment. Additionally, 88% of patients indicated that they required less or no migraine medication for ongoing relief.

“Administration of lidocaine to the sphenopalatine ganglion acts as a ‘reset button’ for the brain’s migraine circuitry,” noted Mandato. “When the initial numbing of the lidocaine wears off, the migraine trigger seems to no longer have the maximum effect that it once did. Some patients have reported immediate relief and are making fewer trips to the hospital for emergency headache medicine,” he said. Because of the minimally invasive nature of the treatment and the medication’s safety profile, Mandato believes patients can have the block repeated, if needed.

While patients reported relief from their migraines, Mandato added that sphenopalatine ganglion blocks are not a cure for migraines; they are a temporary solution as are other current treatment options for chronic headaches.

To further study sphenopalatine ganglion blocks, Mandato will track how the 112 patients have responded six months after treatment. He is also considering conducting a double-blind, prospective study to more rigorously evaluate the effectiveness of the blocks in treating chronic migraines.

Penumbra has announced that its newest vascular embolization device, POD, will debut at the Society of Interventional Radiology’s annual scientific meetingin 2015 in Atlanta, USA.

In addition, the results of two clinical trials featuring Penumbra technology will be presented: the Aneurysm Coiling Efficiency (ACE) study analysing the benefit of high packing density on the long-term outcome of peripheral embolization with the Ruby coil, and multicentre results of the acute limb ischaemia revascularisation study (PRISM) utilising the Indigo thromboembolectomy system.

POD (peripheral occlusion device) is a vessel occlusion tool for vascular embolization. A press release from the company says that POD’s proprietary anchor technology enables precise placement of the device at the target location. POD quickly transitions to a soft packing segment to create a stable dense occlusion. Once the desired positioning is achieved, accurate, instant detachment ensures physician control. POD is designed to be delivered through a high-flow microcatheter, permitting the physician to mechanically occlude distal vessels, the release adds.

“POD is a significant advancement for vascular embolization,” said Adam Elsesser, chairman and chief executive officer of Penumbra. “Its unique design enables POD to anchor to the vessel wall, enabling interventionalists to increase accuracy and packing density during embolization procedures. Increased packing density helps ensure more effective embolization.”

Podium and panel presentations at the SIR annual meeting

Penumbra CEO Adam Elsesser is featured on the plenary session panel, “Innovation, Macroeconomics, and the Future of Minimally Invasive Therapies,”on Sunday, 1 March at 10.30 am.

Corey Teigen, Sanford Health Fargo, North Dakota, will present data on the Ruby coil from the ACE trial. “Experience using large volume detachable coils in the peripheral vasculature: Preliminary results from the ACE multicentre study” will be presented on Sunday, 1 March at 1:27pm·

James Benenati, Baptist Cardiac & Vascular Institute in Miami, Florida, will present data on Indigo system from the PRISM trial. “Revascularization of acute ischaemia and thromboembolic complications in below-the-knee and visceral arterial circulation using a novel mechanical thrombo-aspiration device: Initial findings of the PRISM multicentre study” will be presented Monday, 2 March 2 at 1:09 pm

Company-sponsored events

Penumbra will also host education sessions (Booth #739) where physicians can join in discussions with experienced users, participate in hands-on workshops, and deploy the POD, Ruby, and Indigo in simulated models.

Penumbra will host a dinner symposium, “The Secret to Innovation in Today’s Healthcare Environment – Penumbra’s Embolization and Thrombectomy Technology in the Periphery,” on Tuesday, March 3 at the Omni Hotel. The symposium will include a panel discussion moderated by James B Benenati, Baptist Cardiac & Vascular Institute in Miami, USA and featuring Ziv Haskal, University of Virginia Health System and Rahul Patel, Mount Sinai Hospital in New York, USA.

Researchers at The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust are investigating whether ultrasound therapy can relieve pain in patients whose cancers have spread to the bone.

The technique, known as high-intensity focused ultrasound, concentrates ultrasound energy precisely on a target in the body to thermally destroy tissue. The technology is coupled with magnetic resonance imaging (MRI) guidance to identify, target and track treatment in real time. The treatment produces heat to destroy the nerve tissue in the bone around the tumour causing the pain, while leaving adjacent areas unharmed.

Patients whose cancers have metastasised to the bone can experience intense bone pain, which can severely reduce their quality of life. High-intensity focused ultrasound could provide a non-invasive way of controlling pain for these patients where radiotherapy is no longer an option, or where other treatments have been unable to control the disease.

The first five patients have already been treated in the clinical trial, with encouraging reductions in the pain they were experiencing from bone tumours. If this study proves successful for pain control, it could lead to further studies at The Institute of Cancer Research and the Royal Marsden to thermally destroy local tumours at an earlier stage of the disease, possibly helping to extend life. 

Study co-principal investigator Gail ter Haar, professor of Therapeutic Ultrasound, The Institute of Cancer Research, London, UK, said: “Focused ultrasound is an exciting potential cancer treatment because of its ability to target tumours very precisely. The point onto which the ultrasound beam is focused gets very hot, but the surrounding tissue is left unharmed.”

Study co-leader Nandita deSouza, professor of Translational Imaging, The Institute of Cancer Research, London, and honorary consultant, The Royal Marsden NHS Foundation Trust, said: “We are still learning how best to use focused ultrasound, but we believe it has real potential for improving the quality of life of patients with advanced cancer. Cancers that have spread to the bone can cause intense pain, and further radiotherapy may not be an option. It is early days in our trial, but we hope ultrasound therapy will prove effective at reducing the pain caused by bone metastases, and offer the chance for patients to live the final stages of their lives much more comfortably.”

The trial is part of a wider initiative between the ICR, The Royal Marsden, the Focused Ultrasound Foundation and Philips, the developer of the high-intensity focused ultrasound system.

“MR imaging is emerging in oncology applications, because of its excellent real-time 3D visualisation of both soft tissue anatomy and physiological processes”, said Christopher Busch, general manager MR Therapy at Philips. “Combining focused ultrasound thermal therapies with real-time MR imaging and monitoring is a powerful concept that has the potential to become a new precision treatment tool in oncology.”

Analysis of a 285-patient subgroup treated with ThermoDox plus radiofrequency ablation shows a statistically significant 59% improvement in overall survival when compared to patients who were treated with optimised radiofrequency ablation alone.

Celsion has announced updated results from its retrospective analysis of the 701-patient HEAT study (Hepatocellular carcinoma study of RFA and ThermoDox) of ThermoDox, the proprietary heat-activated liposomal encapsulation of doxorubicin in combination with radiofrequency ablation in hepatocellular carcinoma. HEAT was an international, multicentre, randomised, placebo-controlled study that did not meet its primary endpoint to show sufficient evidence of clinical effectiveness of ThermoDox.

The latest quarterly overall survival analysis in January 2015 demonstrated that in a large, well-bounded, subgroup of patients (n=285, 41% of the study patients), the combination of ThermoDox and optimised radiofrequency ablation provided a 59% improvement in overall survival compared to optimised radiofrequency ablation alone. The hazard ratio at this analysis is 0.628 (95% CI 0.420–0.939) with a p-value of 0.02.

“The consistency of the data from the HEAT Study over the past two years is quite compelling, demonstrating the significant potential for ThermoDox in combination with an optimised radiofrequency ablation regimen to markedly improve overall survival in primary liver cancer patients,” stated Riccardo Lencioni, professor and director, Diagnostic Imaging and Intervention, Pisa University School of Medicine, Italy.  “These findings provide a strong rationale for the ongoing OPTIMA Study and may also underscore the interest of clinical investigators to evaluate the potential of ThermoDox plus optimised radiofrequency ablation for curative intent among intermediate stage hepatocellular carcinoma patients.”

The data from the most recent quarterly HEAT Study post-hoc analysis continued to strongly suggest that ThermoDox may significantly improve overall survival compared to a radiofrequency ablation control in patients whose lesions undergo optimised radiofrequency ablation treatment for 45 minutes or more.  These findings apply to patients with single hepatocellular carcinoma lesions (64.4% of the HEAT Study population) from both size cohorts of the HEAT Study (3–5cm and 5–7cm) and represent a subgroup of 285 patients. 

Michael H Tardugno, Celsion’s chairman, president and chief executive officer said: “The lessons learned from the HEAT study together with prospective supportive preclinical study results formed the basis for our global Phase III OPTIMA study evaluating ThermoDox in combination with a standardised radiofrequency ablation protocol in primary liver cancer, and we look forward to sharing this latest data update with our investigators worldwide as we continue to advance this programme.”

The phase III OPTIMA study is expected to enrol up to 550 patients globally in up to 100 clinical sites in the USA, Europe, China and Asia Pacific, and will evaluate ThermoDox in combination with optimised radiofrequency ablation, which will be standardised to a minimum of 45 minutes across all investigators and clinical sites for treating lesions three to seven centimetres, vs. standardised RFA alone. The primary endpoint for the trial is overall survival, which is supported by post-hoc analysis of data from the company’s 701 patient HEAT Study, where optimised radiofrequency ablation has demonstrated the potential to significantly improve survival when combined with ThermoDox. The statistical plan calls for two interim efficacy analyses by an independent Data Monitoring Committee (iDMC).

Gore has completed enrolment for the Gore REDUCE clinical study, a prospective, randomised, multicentre, multi-national trial designed to demonstrate safety and effectiveness of the Gore Helix septal occluder and Gore septal occluder for patent foramen ovale closure in patients with a history of cryptogenic stroke or imaging-confirmed transient ischaemic attack.

“With enrolment in the REDUCE study now complete, we move one major step closer to providing additional evidence on the best treatment for stroke patients with PFO,” said Scott Kasner, professor of Neurology and Director of the Comprehensive Stroke Center at the University of Pennsylvania Medical Center, USA, and US Neurology principal investigator for the REDUCE study. “Prior studies have left us with substantial uncertainty regarding the role of patent foramen ovale closure in reducing recurrent stroke risk. We are confident that the rigorous approach to patient selection and the optimised design of the REDUCE Study will provide robust and reliable data to inform clinical decision making in this patient population.”

The study includes 65 investigational sites in the USA, Canada, UK, Denmark, Norway, Sweden, and Finland that enrolled a combined 664 subjects. All subjects will complete a minimum of two years of follow-up evaluations before analysis of the study endpoints.

Corindus Vascular Robotics has initiated a clinical trial of its CorPath system in peripheral vascular interventions. The study is currently enrolling patients at the Medical University of Graz in Graz, Austria, and is led by Marianne Brodmann, a leading researcher within the university’s Division of Angiology, in combination with Hannes Deutschmann, of the Medical University of Graz Department of Radiology, and study chairman, Ehtisham Mahmud, director, Sulpizio Cardiovascular Center-Medicine, UC San Diego, USA.

“I routinely use the CorPath System in complex percutaneous coronary intervention (PCI) cases and it reduces my exposure to a significant amount of scatter radiation,” said Mahmud. “The value of precision and protection afforded to physicians performing PCI through robotic technology is considerable. As peripheral vascular procedures are lengthy and often complex, the ability to translate the effectiveness of robotic technology to peripheral interventions has tremendous potential to be of benefit to both patients and physicians.”

The trial is a prospective, single-arm, single centre study that will enrol up to 20 patients. Researchers participating in the study will assess the safety and effectiveness of the CorPath system in recanalising lower extremity arterial blockages during peripheral angioplasty procedures.

“It was astonishing how easy it was to advance the guidewire and balloon catheter in a precise controlled manner in the superficial femoral artery,” said Brodmann. “The results of this trial can mean the extension of the CorPath system’s capabilities to a greater range of procedures to further transform care delivery in the cath lab.”

“The potential for interventionists to utilise the precision of robotics for peripheral vascular intervention may have significant implications for the care they provide to their patients, and their own health as well,” said David Handler, president and chief executive officer, Corindus Vascular Robotics. “As concern about the risks of cumulative radiation exposure continues to grow for operators in the cath lab, an expansion of the CorPath system’s indications, if enabled by a successful clinical trial, would increase the number and variety of cases that can be performed under the protection of CorPath, which can be significantly beneficial to physician health.”

Developed by Corindus Vascular Robotics, the CorPath system is the first FDA-cleared medical device to bring robotic-assisted precision to coronary angioplasty procedures. The system is currently indicated in the USA for PCI only. During the procedure, the interventional cardiologist sits in the radiation-shielded interventional cockpit and advances stents and guidewires with millimetre by millimetre precision.

A study that set out to assess the safety and efficacy of prostate artery embolization in small volume benign prostatic hyperplasia (<50cc) revealed that the procedure appears to offer positive clinical benefits for patients out to six months.

Sandeep Bagla, Inova Alexandria Hospital, Alexandria, USA, presented the results at the 27th annual International Symposium on Endovascular Therapy (ISET, 31 January–5 February, Hollywood, USA).

“Traditional urologic surgery of small-volume benign prostatic hyperplasia is associated with high failure rates and complications such as bladder neck strictures and contractures. While prostate artery embolization is postulated to be effective secondary to gland size reduction, we hypothesise that it may be equally effective in patients with small volume glands,” the investigators wrote in the abstract.

Subsequent to an Institutional Review Board approval, the researchers carried out a retrospective study of 78 consecutive prostate artery embolization patients from January 2011 to July 2014. They evaluated the patients at baseline; one; three; and six months using the American Urological Association symptom index (AUA-SI)  including quality of life related symptoms, International Index of Erectile Function (IIEF), and prostate imaging (magnetic resonance imaging, ultrasound, or computed tomography at baseline).

“We stratified the patients into two groups: Group 1 consisted of patients with prostate volume of less than 50cc and Group 2 consisted of those patients whose prostate volumes greater than 50cc. We analysed patients individually from baseline to one, three, and six months and between groups at each follow-up to assess for differences in outcome,” Bagla said.

“There were no significant differences in baseline age, AUA-SI scores, quality of life scores or IIEF scores between the groups. Patients were around 65 years of age, and had mean AUA-SI scores of 26.4. They also scored very poorly in terms of quality of life scores,” he further noted.

For the 16 patients in Group one the baseline volumes averaged around 37cc.  For the 62 patients in Group 2, prostate volumes averaged 108.5cc.

“We achieved technical success in all patients in Group 1 and 59/62 in Group 2, with two unilateral embolizations and one unsuccessful procedure secondary to bilateral atherosclerotic occlusion in the latter group.

Data was available for 77 patients and the researchers observed a statistically significant reduction in AUA-SI scores in both groups from baseline to one, three and six months.  “In Group 1, we saw a reduction from a score at baseline of 27.2 to 12.7 at one month, 12.0  at three months and 11.2 at  six months (p<0.0006). In Group 2, we saw a reduction from the score at baseline from 26.1 to 15.3, 14.4, and 14.9 at one, three and six months respectively (p<0.0001),” Bagla said.

These results prompted the investigators to conclude that the procedure could offer crucial benefit to those patients with limited surgical options. Future study aimed at evaluating recurrence rates is suggested, they noted.

Portugal group to present mid- and long-term clinical outcomes

Joao-Martins Pisco, Hospital Saint Louis, Lisbon, Portugal, and team are to present the medium- and long-term clinical outcome of prostate artery embolization in 460 patients with benign prostatic hyperplasia at the Society of Interventional Radiology’s (SIR’s) upcoming Annual Scientific Meeting (28 February–5 March 2015, Atlanta, USA).

Pisco’s group will demonstrate that in this large cohort, there were less than 2% technical failures and that a statistically significant improvement of all evaluated parameters was observed, over time.

 
This has led the investigators to conclude that prostatic artery embolization is a safe, well-tolerated, and efficient outpatient procedure, for patients with benign prostatic hyperplasia and moderate to severe lower urinary tract symptoms. The team from Portugal note that their research demonstrated good mid-term and long-term results and no sexual dysfunction associated with the procedure.

Horst Sievert, CardioVascular Center, Frankfurt, Germany reported “interesting, but inconclusive observations” from a small cohort of patients enrolled in the RETREAT (Renal denervation with ultrasound after failed radiofrequency denervation) study.

The findings were presented at the Leipzig Interventional Course (LINC, 27–30 January, Leipzig, Germany).

“Renal denervation with ultrasound after performed after prior denervation with radiofrequency seems to be safe. After an initial decrease of blood pressure after one month, we observed an increase in blood pressure in this small number of patients, a finding which has not been seen in other denervation studies,” said Sievert.

RETREAT is a physician-initiated prospective, multicentre study with no industry funding in which 30 patients will be enrolled.  Its purpose is to evaluate the effect of renal denervation using ultrasound energy (with Recor’s Paradise system) after failed denervation with radiofrequency (with Medtronic’s Symplicity system).

Sievert said: “Enrolment in the RETREAT study coincided with the publication of the SYMPLICITY HTN-3 study results following which the reimbursement for renal denervation was stopped in Germany. There was a decline in referrals for renal denervation and new treatment modalities for hypertension began to be explored. This resulted in enrolment becoming very slow and almost stopping.”

At the outset, Sievert identified the many potential reasons why renal denervation could fail as a therapy including that renal denervation may not work at all; changes in medication (either before the procedure or in the follow-up period); patient specific factors such as type of medication or race; or technical issues with the procedure (such as incomplete ablation, or ablation that is not circumferential.) “It might also be that the technology is not good enough to destroy all renal nerves in all patients,” Sievert explained.

Renal denervation with ultrasound

As with radiofrequency, renal denervation is achieved with ultrasound by inducing thermal necrosis. “Ultrasound energy passes through fluids and generates frictional heating in soft tissues. Unlike radiofrequency, no direct tissue contact is required and therefore stability of the catheter is less of an issue,” he said.

The paradise system is an ultrasound transducer that is mounted inside a low pressure balloon. Cooled water in the balloon protects the endothelium against heat. The procedure involves 30 seconds of circumferential heating independent of the positioning of the device.

RETREAT study

Patients were included in RETREAT if they had had a first renal denervation treatment with the Symplicity catheter at any time in the previous year and had been classified as a non-responder, defined in this study as those who either experienced a blood pressure drop of less than 10mmHg or because their blood pressure was still high (above 160mmHg). Patients also had to have a systolic office blood pressure of 140mmHg and be on optimal medical therapy consisting of three or more antihypertensive drugs including one diuretic, all at the maximum tolerated dose in order to be eligible. Secondary hypertension also had to be ruled out for these patients before the first procedure was performed.

The primary endpoints of RETREAT were a change in office and ambulatory blood pressure 12 months after the procedure, or a change in antihypertensive medications. The secondary endpoint was freedom from adverse events.

At baseline, examinations included measurement of office-based blood pressure and 24-hr ambulatory blood pressure, a blood test to determine creatinine levels, and MRI/ angiographic evaluation to rule out renal artery abnormalities including stenosis from the first procedure. Follow-up was scheduled at one, three, six and 12 months for measurement of office-based pressure, and ambulatory blood pressure, changes in medication, and adverse events. A renal duplex ultrasound was performed after six months and a blood test for creatinine was done after six and 12 months.

In the first renal denervation procedure with radiofrequency, both renal arteries were treated in each patient. Circumferential ablation was performed with 10–20 ablations per patient. There were no adverse events seen during the procedure. After six months, if there was an office-based blood pressure decrease of less than 10mmHg and/or office-based blood pressure of >160mmHg, the patient was enrolled in the trial and second renal denervation with ultrasound was performed.

RETREAT procedure

Eight patients were treated with the Paradise system with 2–3 ablations per artery being performed. “There was technical success in all patients and no device-related adverse events occurred. There was one false aneurysm seen. We observed a decrease in office-blood pressure in the first month and then this decrease actually disappeared over time. (See table 1) We have not seen this in other trials. Similarly, when we looked at the ambulatory blood pressure, there was a large decrease initially and then a diminishing effect over time. There were no changes in creatinine levels,” Sievert concluded.

Table 1:

The US FDA has cleared the Enroute transcarotid neuroprotection system (Silk Road Medical) for marketing. The system is for use during carotid artery stenting procedures and is the first one designed to access the carotid arteries through an incision in the neck, instead of the groin. It uses a blood flow reversal system to capture pieces of the blockage dislodged during the procedure.

“The ENROUTE technology enables a true hybrid procedure offering the best of both worlds– the critical protection against peri-procedural stroke we have achieved with carotid endarterectomy with the ability to reduce surgical complications using minimally invasive endovascular techniques,” said Manish Mehta, professor of Surgery, Albany Medical College, Albany, and an investigator in the ROADSTER trial. “It is also a quick, efficient procedure which can be performed under local anaesthesia with minimal scarring, which is highly beneficial for both the patient and the operator.” 

Richard Cambria, chief of the Division of Vascular and Endovascular Surgery, Massachusetts General Hospital and the national co-principal investigator of the ROADSTER trial along with colleague Christopher Kwolek, said: “We continue to operate on high surgical risk patients because transfemoral carotid artery stenting has shown excess peri-procedural stroke risk.  With the Enroute transcarotid neuroprotection system, we now have carotid endarterectomy-like neuroprotection and a simplified procedure that can fulfill the promise of carotid artery stenting.”

The FDA cleared the Enroute transcarotid neuroprotection system based in part on the results of the ROADSTER trial, which achieved a 30-day stroke rate of 1.4% in the pivotal cohort, the lowest to date for any prospective trial of carotid artery stenting. There were no major strokes and there were no strokes in important high risk subgroups, including the elderly (age ≥75), women, and symptomatic patients.

A press release from the US FDA said: “The trial showed the rate of stroke, heart attack, and death among the patients who received the Enroute system was 3.5%, significantly lower than the study performance goal of 11%. At least one serious adverse event occurred in 14.2% of patients, including excessive bleeding or injury at the device access site, low blood pressure due to the device or procedure, and blood clot formation within the placed stent. These events are consistent with the type and rate of serious adverse events associated with other carotid artery stenting procedures.”

Silk Road Medical has also submitted a premarket approval application for the Enroute transcarotid stent system, which is an optimised stent delivery system designed for use with the Enroute transcarotid neuroprotection system.

The ROX CONTROL HTN, an international randomised controlled trial, published online ahead of print in The Lancet in late January, has demonstrated that creation of a central arteriovenous anastomosis in patients was associated with significantly reduced blood pressure and hypertensive complications at six months. The study was funded by Rox Medical.

Investigators led by Melvin D Lobo, Queen Mary University of London, UK, randomised 83 patients with uncontrolled hypertension to either receive arteriovenous coupler therapy in addition to their antihypertensive regimen (n=44) or continue on their current pharmaceutical treatment alone (n=39). They found that the group treated with the intervention had a significant drop in blood pressure whereas patients who were on medication alone did not experience a significant change in their blood pressure.

Creation of the arteriovenous anastomosis involves Rox Medical’s flow procedure, a minimally invasive, catheter-based procedure in which a small nitinol coupler is inserted between the artery and vein in the upper leg. The procedure reduces peripheral vascular resistance and is fully reversible. The ROX coupler device holds CE Mark approval in Europe but remains investigational in the USA.

In order to be considered for enrolment in the ROX CONTROL HTN trial, patients had to have an office systolic BP of at least 140mmHg and an average daytime ambulatory pressure of at least 135/85mmHg while taking at least three antihypertensive medications of different classes, including a diuretic. The primary endpoint was mean change from baseline in office and 24h ambulatory systolic blood pressure at six months.

The investigators found that mean office systolic blood pressure reduced by 26.9mmHg in the arteriovenous coupler group (p<0·0001) and by 3.7mmHg in the control group (p=0·31). Mean systolic 24h ambulatory blood pressure reduced by 13.5 mmHg (p<0·0001) in the group that received arteriovenous coupler and by 0.5mmHg (p=0·86) in controls.

This early stage research was described as promising by an accompanying Lancet commentary and is a shot in the arm for interventional treatments of resistant hypertension in the aftermath of decreasing referrals and cessation of reimbursement for renal denervation.

As reported, the investigators further observed that implantation of the arteriovenous coupler was associated with late ipsilateral venous stenosis in 12 (29%) of 42 patients and was treatable with venoplasty or stenting. “This approach might be a useful adjunctive therapy for patients with uncontrolled hypertension,” the authors wrote.

Gore has received approval from Health Canada for two innovations of the Viabahn endoprosthesis with Propaten bioactive surface. The newly-approved 25cm-long endoprosthesis and a lower profile delivery system gives Canadian physicians more options in treating patient anatomies.

The Viabahn is the longest length stent-graft available, and can be used to treat long-segment peripheral arterial disease. The device is constructed with a durable, reinforced, biocompatible, expanded polytetrafluoroethylene (ePTFE) liner attached to an external nitinol stent structure. Gore says that the flexibility of the device enables it to traverse tortuous areas and conform closely to the complex anatomy of the artery. The stent graft features the addition of proprietary heparin-bonded technology. The end-point covalent bonding keeps heparin anchored to the endoprosthesis surface while the bioactive site remains free to interact with the blood.

“The longer 25cm Viabahn endoprosthesis will lead to safer treatment and produce better patient results while being cost-effective and reduce procedure times,” said Andrew Benko, University of Sherbrooke. “The addition of a lower profile Gore device creates safe treatment options for patients with challenging anatomies and will be ideal for contralateral work.”

Gore’s next generation device enables a reduction in delivery profile to 6 Fr for 5mm and 6mm devices and 7 Fr for 7 and 8mm devices and is delivered over a 0.018” or 0.014” guidewire.

US hospitals this week began using the IN.PACT Admiral drug-coated balloon (Medtronic plc) to treat patients with peripheral arterial disease in the superficial femoral and popliteal arteries.

Recently approved by the US FDA, the IN.PACT Admiral drug-coated balloon offers patients a new therapy option that has demonstrated the best clinical outcomes ever reported for this disease state and has been proven to reduce the need for costly repeat procedures that are commonly associated with other available interventional therapies.

The first uses of the new medical device following US FDA approval took place at New York-Presbyterian Hospital/Columbia University Medical Center by William Gray; Detroit Medical Center’s Harper Hospital by Mahir Elder; Yuma Regional Medical Center by Joseph Cardenas of the Heart Center of Yuma; and Terrebonne General Medical Center in Houma, by Craig Walker of Cardiovascular Institute of the South.

“As an investigator in the clinical trial that contributed to this device’s FDA approval, I have seen firsthand how well the IN.PACT Admiral drug-coated balloon works as a treatment for peripheral arterial disease in the upper leg,” said Gray.

“Based on the trial results, which were recently published in the journal Circulation, I see the IN.PACT Admiral drug-coated balloon fast becoming a first-line therapy option for patients with this condition.”

The US launch of the IN.PACT Admiral begins about a week after Medtronic completed its acquisition of Covidien.  This acquisition significantly expands Medtronic’s peripheral vascular sales force, which will facilitate access to the new device.
The IN.PACT Admiral DCB received the CE mark in 2009 and has been widely adopted by European physicians, leading the market with nearly 100,000 patients treated.

A new computer programme allows interventionalists to assess blood flow in real-time while they are using flow-diverter devices to treat intracranial aneurysms, suggests a pilot study presented at the 27^th annual International Symposium on Endovascular Therapy (ISET, 31 January–5 February, Hollywood, USA).

The researchers set out to study the effect of flow diverter implantation on blood flow in the vicinity of treated aneurysms, and aimed to develop a computer programme for real-time, quantitative assessment of blood flow during flow diverter implantation procedures.

Flow diverters are a class of endovascular devices for treating brain aneurysms by reconstructing the path of arterial flow and excluding an aneurysm from the circulation. “Increasing experience with flow diverters worldwide has shown that adverse flow changes due to the treatment may lead to severe complications in patients. Flow diverters typically are used to treat large (2– 2.5cm) or giant (more than 2.5cm) aneurysms, or those with wide necks,” the authors reported in the abstract.

“Until now, there was no safe way to measure the blood flow in real-time, during the procedure, including flow reduction to the aneurysm and flow to the rest of the brain,” said Aichi Chien, assistant professor of interventional neuroradiology, University of California, Los Angeles, USA. “Because the programme quantifies blood flow automatically, doctors do not need to stop the procedure to get this information, which helps them make the best decisions during the procedure.”

The Intracranial Stent Flow Mapping computer programme – IS FlowMap – takes advantage of the standard digital subtraction angiography (DSA) imaging being taken during the procedure. The program analyses the standard images, compares the difference in blood flow image to image and calculates the changes within seconds, providing that information to the interventionalist during treatment. If blood flow is not optimal, the doctor may choose to use a different treatment, such as placing coils in the aneurysm.

In the study, 13 patients were treated, and the average reduction in blood flow entering the aneurysm was 48%. The flow diverter healed the aneurysm in 11 (85%) of the patients.

“This pilot study quantitatively comparing the flow before and after flow diverter treatment showed that treatment leads to a significant and immediate reduction in flow entering an aneurysm,” the authors noted. 

“There are many advances in devices to treat patients with aneurysms and other vascular disease, but the technology to see the effects of those devices is very limited,” said Chien. “The IS FlowMap provides a simple way to analyse the treatment without any additional procedures or risk. We will be able to use this information moving forward to compare treatments and determine what amount of blood flow change is optimal.”

The results were presented at the seventh annual Symposium on Clinical Interventional Oncology (CIO, 31 January–5 February, Hollywood, USA), in collaboration with the International Symposium on Endovascular Therapy (ISET, 31 January–5 February, Hollywood, USA) by Ravi Murthy, Department of Interventional Radiology, Division of Diagnostic Imaging, The University of Texas MD Anderson Cancer Center, Houston, USA.

Providing some background, Murthy explained that hypoxic environments, as those that occur in tumours, are favourable for Clostridium subspecies to germinate. “C novyi-NT induces a microscopic and tumour-confined lysis after intratumoural injection in rat orthotopic brain tumour models and spontaneous solid tumours in dogs, with the commonest toxicity being the symptoms accompanying a bacterial infection.

“When tumours reach a certain size, parts of them do not receive oxygen, which makes them resistant to conventional therapies such as radiation and chemotherapy,” said Murthy. “C novyi-NT thrives under these conditions, hones in on the low-oxygen areas and destroys tumours from the inside while sparing normal tissue.”

The researchers are conducting a first-in-man phase I study selecting therapy refractory solid tumours palpable, or identifiable under imaging guidance and amenable to percutaneous injection of C novyi-NT spores.

“Tumour environment hypoxia is dynamic, spatially heterogenic, and not evaluable using clinical imaging technology, thereby rendering localisation of the optimal intratumoural injection location for spore inoculation impossible. In order to compensate for this unknown parameter, we employed a staged, multifocal intratumoural delivery process to theoretically increase the likelihood of spore deposition within a milieu conducive for germination,” he said. 

The team is enrolling advanced solid tumour cancer patients with at least one injectable tumour >1cm in five dose-escalating cohorts to receive single 3cc intratumoural injections of 1E4, 3E4, 1E5, 3E5, or 1E6 C novyi-NT spores.

They injected the C. novyi-NT spores through the skin under radiographic guidance into tumours in six people. Growth of C. novyi was confirmed when computed tomography (CT) and magnetic resonance imaging (MRI) scans of the treated tumours showed gas pockets and evidence of necrosis, or cell death. Fever and elevated white blood cell count provided further evidence that the bacteria were growing and destroying cancer cells.

Six patients have been treated to date. Five are alive and one died from unrelated causes after seven months.  “Two patients demonstrated clinical evidence of germination within 72 hours corroborated by imaging and pathology confirmed oncolysis. The liquefied components of the tumour were managed with evacuation via percutaneous drainage and pre-specified protocol mandated multi-antimicrobial therapy,” Murthy said.

Once inside the tumour, the C. novyi-NT spores germinate, kill tumour cells and then feast on the waste. C. novyi-NT bacteria stop growing and die when exposed to oxygen which is abundant in healthy tissue. C. novyi-NT also is known to provoke an immune response against the cancer.

“Essentially, C. novyi-NT causes a potent cancer killing infection in the tumour,” said principal investigator Filip Janku, associate professor, Department of Investigation Therapeutics, MD Anderson Cancer Center.

Murthy and colleagues have previously used naturally occurring canine tumours as a translational bridge to human trials as reported in the journal Science Translational Medicine in August 2014. “Canine tumours are more like those of humans because they occur in animals with heterogeneous genetic backgrounds, are of host origin, and are due to spontaneous rather than engineered mutations. We found that intratumoural injection of C novyi-NT spores was well-tolerated in companion dogs bearing spontaneous solid tumours, with the most common toxicities being the expected symptoms associated with bacterial infections. Objective responses were observed in 6 of 16 dogs (37.5%), with three complete and three partial responses.

At the Leipzig Interventional Course (LINC 2015), Stephan Duda presented findings from the ILLUMENATE FIH (first-in-human) study that demonstrate primary patency at 12 months of 89.5% in the pre-dilation plus drug-coated balloon group and 77.5% in the direct balloon group, when using the Stellarex drug-coated balloon.

The ILLUMENATE FIH study is a prospective, multicentre study designed to assess the clinical performance of the Stellarex drug-coated angioplasty balloon (Spectranetics) used to restore and maintain blood flow to the arteries of the leg in patients with peripheral arterial disease.

Duda, from Jüdisches Krankenhaus Berlin, Germany, said that the data include results on the 50 pre-dilated and 22 direct drug-coated balloon patients studied.

The study reported a primary patency (defined as the treated artery remaining open without further treatment required or renewed blockage detected by ultrasound scanning) of 89.5% in the pre-dilation plus balloon group and 77.5% in the direct balloon group at 12 months. The freedom from clinically driven target lesion revascularisation rate at 12 months was 90% in the pre-dilation plus balloon group and 85.4% in the direct balloon group (p=0.5396). Duda added that the primary patency of 80.3% in the pre-dilation plus balloon group at 24 months demonstrates continued durability of the procedure. There were no major amputations or cardiovascular deaths in either group. At six months, the late lumen loss was 0.08 in the direct balloon cohort and 0.54 in the dilation plus balloon group, which shows, according to Duda, a “good drug effect”.

The study’s average lesion length was approximately 7.2cm in pre-dilated patients and 6.4cm in the direct balloon patients.

Duda states, “When it comes to patient care, physicians demand proven clinical results that show positive outcomes. With freedom from clinically driven target lesion revascularisation at 90% in the pre-dilation plus balloon group and 85.4% in the direct balloon group, this trial has proven results that will impact the choice of treatment.”

The Stellarex platform received CE mark approval in December 2014. Spectranetics has now launched the product in Europe, with US commercialisation anticipated in 2017, following FDA approval.

Combined data from more than 1,000 patients is being collected to assess the overall survival benefit of adding first-line SIR-Spheres Y-90 resin microspheres treatment to a current chemotherapy regimen for inoperable metastatic colorectal cancer.

Sirtex has announced the completion of patient enrolment in FOXFIRE and FOXFIRE Global, two large multicentre studies that added liver-directed radiation therapy with SIR-Spheres Y-90 resin microspheres to a current standard of care chemotherapy regimen in the first-line treatment of more than 560 patients recently diagnosed with inoperable metastatic colorectal cancer.

By previous design, the data of FOXFIRE and FOXFIRE Global will be combined with the findings of 500-patient SIRFLOX study to form a database of more than 1,000 patients that has sufficient statistical power to evaluate whether first-line SIR-Spheres microspheres in combination with a standard-of-care chemotherapy versus chemotherapy alone can significantly increase the overall survival of patients with colorectal cancer liver metastases. The results of this combined study are expected to be known in the first half of 2017.

“We are very pleased that FOXFIRE and FOXFIRE Global have so quickly reached their ambitious enrolment goals,” said Gilman Wong, CEO of Sirtex. “Announcing the results of the earlier SIRFLOX study remains our immediate priority. However, the fact that enrolment in all three studies is now complete presents us an unprecedented opportunity to demonstrate the important role that SIR-Spheres microspheres may play in the treatment of patients with metastatic colorectal cancer, for whom liver tumours are all too often the greatest cause of failing health. We are grateful to the many doctors, nurses and other medical staff, and especially the patients and their families who have made this important undertaking possible.”

The FOXFIRE Study, which enrolled more than 360 patients in 32 UK cancer centres, was initiated in 2008 by the Oxford Oncology Clinical Trials Office (OCTO) in collaboration with the UK National Cancer Research Institute. It is sponsored by the University of Oxford, and funded by the Bobby Moore Fund for Cancer Research UK, the Experimental Cancer Medicine Centre (ECMC) Network and Sirtex.

The FOXFIRE chief investigators are Ricky Sharma, consultant clinical oncologist at the Oxford University Hospitals NHS Trust, UK, and Harpreet Wasan, consultant medical oncologist, Imperial College Healthcare, Hammersmith Hospital, London, UK.

“Despite significant advances we have made in treating this disease with chemotherapy and biologically targeted therapies, optimising the care for patients with colorectal cancer that has spread to the liver remains a significant challenge in oncology,” Sharma said.

“For rectal cancer, the combination of radiotherapy and chemotherapy is an established standard of care. Treating the liver with the same combination of treatments has been difficult due to the sensitivity of healthy liver tissue to radiotherapy. These exciting clinical trials combine a safe form of internally administered radiotherapy with routine chemotherapy. Recruiting over 1,000 patients to these trials represents an important step forward in determining whether targeting these tumours with both treatments acting together is better than using chemotherapy on its own.”

Wasan added: “This is the reason why we needed to conduct definitive research in the early use of liver-directed radiotherapy with SIR-Spheres Y-90 resin microspheres in these patients. Completing enrolment in the FOXFIRE study is an important milestone in our work to address whether adding selective internal radiation therapy to first-line chemotherapy will provide an important gain in overall survival for patients with colorectal cancer liver metastases.”

FOXFIRE Global, which enrolled more than 200 patients and was funded by Sirtex, began in 2013 in a network of more than 80 centres in Australia, New Zealand, Asia Pacific, Israel, Western Europe and the United States. The principal investigator of FOXFIRE Global is Peter Gibbs, associate professor of Medical Oncology, Royal Melbourne Hospital and Western Hospital, Melbourne, Australia.

“Completing these three studies was an enormous undertaking, but it is no less enormous than the need for more effective ways to treat colorectal cancer that has metastasised to the liver, which is the most common site of its spread and affects several hundred thousand patients worldwide each year,” Gibbs explained. “Obviously, we do not yet know if this combination of chemo-radiotherapy will prove successful in early treatment of metastatic colorectal cancer, but we do know from published data that metastatic colorectal cancer patients who no longer respond to chemotherapy have already benefitted from selective internal radiation therapy, or SIRT, as it is more widely known.”

Interventional radiologists Gerard Goh and Jim Koukounaras, assisted by Ken Thomson, performed performed transarterial chemoembolization (TACE) as their first procedure with Magellan at The Alfred Hospital in Melbourne, Australia. 

The Magellan Robotic System was installed in January 2015 in collaboration with Medtel Pty Limited, Hansen Medical’s exclusive distribution partner in Australia and New Zealand.

“The Magellan Robotic System allowed us to gain catheter stability in challenging anatomy,” said Goh. “Navigating the tortuous anatomy of the blood vessels supplying the liver would have been extremely challenging by conventional techniques.”

Andrew Lehmann, managing director of Medtel Pty said: “It is intended that The Alfred will become the first of many reference sites in Australia and New Zealand to deliver the patient and clinician benefits of Magellan Robotic System. We thank Hansen Medical for their role in supporting the installation and training of clinicians.”

InspireMD has received CE mark approval for its new CGuard RX rapid exchange system for its MicroNet covered carotid stent technology.  Concurrently, the company announced positive six-month follow up data from its CGuard CARENET (Carotid embolic protection study using MicroNet) trial at the LINC meeting in Leipzig, Germany.

InspireMD says that the RX delivery system, designed for use with the CGuard MicroNet, will enable clinicians to place the CGuard technology using an easy-to-use, and familiar, delivery system. The CGuard MicroNet mesh covered carotid stent remains unchanged.

Piotr Musiaâek, Jagiellonian University Medical College at John Paul II Hospital, Krakow, Poland, and co-principal investigator for the CARENET study, presented the six-month data at a late breaking trial session at the LINC meeting. There was one major adverse cardiac and cerebrovascular event reported at six months which was not device-related. This six-month adverse event rate is substantially lower than rates reported in other conventional carotid stenting trials. The duplex ultrasound analysis performed at six months confirmed widely patent carotid arteries, which were stented with the CGuard as determined by flow measurements indicating no sign of vessel narrowing, consistent with historical data of conventional carotid artery stenting. Importantly, the external carotid artery showed unimpeded flow in 100% of cases demonstrating that the MicroNet allows excellent blood flow into bifurcated arteries. The reduction in both the incidence and the volume of new ischaemic lesions, as well as this six-month data showing minimal restenosis concern, and 100% patent internal and external carotid arteries, indicates that the therapeutic benefits of the CGuard MicroNet technology may extend well beyond the acute procedural period.

Alan Milinazzo, chief executive officer of InspireMD, commented, “Physicians continue to be impressed with the superior clinical data and our six-month results further validate that CGuard with MicroNet may represent a superior next generation of stenting technology. We plan to use the new clinical data and the RX approval to expand our commercial launch activities starting immediately.”

Data presented at the Leipzig Interventional Course 2015 (LINC, 27– 30 January, Leipzig, Germany) demonstrate significant improvement in dissection repair with the Tack Endovascular System (Intact Vascular).

The Tack Endovascular System is a new technology designed to repair dissections in the artery wall that frequently occur as a complication of balloon angioplasty. The system allows physicians to repair these dissections while leaving a minimal amount of foreign material in the artery, reducing mechanical stress on the artery, and preserving future treatment options.

TOBA (Tack optimized balloon angioplasty) enrolled 138 subjects at 13 sites in Europe. All study subjects were suffering from severe peripheral arterial disease in one or both legs. They were treated with the Tack Endovascular System following standard balloon angioplasty in the superficial femoral and popliteal arteries.

Marc Bosiers, head, Department of Vascular Surgery, AZ St Blasius Hospital in Belgium, a co-principal investigator of the trial, presented the data at LINC. Dierk Scheinert, University Hospital Leipzig, Leipzig, Germany, is also a co-principal investigator.

Some of the key conclusions from the TOBA study included:

• Freedom from clinically driven target lesion revascularisation rate at 12 months was 89.5%. Clinically driven target lesion revascularisation rate accounts for repeat procedures, or re-interventions, due to recurrent symptoms related to the treated lesion.
• One-year Kaplan-Meier patency rate was 76.4%. Most of the subjects had significant dissections, which are graded from A to F. In the study, 74% of the patients had dissections graded C or higher, and less than 5% of the patients had simple Grade A dissections, based on independent core lab adjudication.
• Technical success rate was 98.5%.
• There was no migration or movement of Tack implants throughout the one-year follow-up period.

Bosiers stated, “The TOBA experience demonstrates that the long-term results from angioplasty can be substantially improved if we repair arterial dissections using this new approach that minimises vessel trauma and the metal we leave behind. The Tack supports the dissection and allows the vessel to heal, while preserving future treatment options for patients.”

Patients in the study demonstrated a marked improvement in their ability to walk and a reduction in the leg pain they experienced, as measured by the Rutherford Classification system. The study saw a reduction in patients with Rutherford class 3 disease from 73.8% before treatment to 5.7% at 12 months, with a majority of the patients achieving Rutherford class 0 (no symptoms). Patients also reported significantly less pain, with no pain during exercise increasing from 5.4% before treatment to 76.2% at 12 months. In addition, ankle brachial index (ABI) improved 38% from baseline at 12 months. Equally important, no subjects had a major amputation at 12 months.

Marianne Brodmann, professor of Angiology, Medical University of Graz, Austria, who was the lead enroller in the trial, said, “This new approach of low radial force and spot treatment of dissections support our desire to leave as little metal behind as possible. I look forward to using the Tack in conjunction with drug coated balloons and conducting further research, to reduce lining the artery with stents.”

Based on these promising results, the company is pursuing an expanded study (TOBA II) that will assess the performance of the Tack Endovascular System in a larger population and will include US investigators.

Clinical work and data will be presented on Humacyte’s novel bioengineered blood vessel at the 27^th International Symposium on Endovascular Therapy (ISET, 31 January–4 February, Hollywood, USA).

Jeffrey H Lawson, vice Chair for Research, Professor of Surgery and Pathology at Duke University Medical Center, Durham, USA, will present a keynote lecture titled “Bioengineering and the potential to create new blood vessels” at ISET.

Lawson, who is also director of the Vascular Research Laboratory, director of Clinical Trials for the Department of Surgery and clinical consultant to Humacyte, will discuss early stage development and clinical testing of Humacyte’s off-the-shelf human bioengineered blood vessel replacement that is being developed for key applications in regenerative medicine and vascular surgery. 

“More than 400,000 haemodialysis patients with end stage renal disease suffer from yearly surgical procedures having to do with graft complications,” said Lawson. “Through advances in tissue engineering, we can potentially access non-living, immunologically tolerated blood vessels for implantation that might allow us to reduce number of interventions. This prospective alternative to the current standard of care has the potential to be a significant game-changer for patients.”

Humacyte’s bioengineered blood vessel is cultivated with donated human cells on a tubular scaffold, and then decellularised to allow for allogeneic, off-the-shelf investigational use. The bioengineered blood vessel has performed better than other synthetic and animal-based implants in pre-clinical tests. The product received ‘Fast Track’ designation in 2014 from the US FDA for vascular access in patients with end stage renal disease requiring haemodialysis, expediting the regulatory review process. 

Alan Lumsden, vascular surgeon and director of the Methodist DeBakey Heart & Vascular Center, performed the procedure at Houston Methodist Hospital in Houston, Texas using the Magellan robotic system (Hansen Medical) to remove a filter manufactured by Cook Medical.

Lumsden said: “This is another great example of how the precision, stability and control of the Magellan robotic catheters are being applied to help improve the predictability of many of the complex endovascular procedures that we perform on a daily basis.”

Retrievable inferior vena cava filters can be removed from the body when the risk of pulmonary embolism has subsided or when the patient is able to tolerate blood thinning medications. The filter is retrieved via an endovascular procedure in which a hook on the filter is “snared” by a specially designed wire and pulled back into a catheter, and then removed from the body. Retrieval may be technically challenging or fail when a filter has tilted inside the body. By enabling a physician to change the angle and direction of the robotic catheter inside the blood vessel, Magellan may help a physician to more precisely target the hook of a tilted filter.

Magellan’s remote workstation allows physicians to navigate through the vasculature while seated away from the radiation field, potentially reducing physicians’ radiation exposure and procedural fatigue.

The Society of Interventional Radiology Foundation has released a statement announcing that the NIH-sponsored ATTRACT (Acute venous thrombosis: thrombus removal with adjunctive catheter-directed thrombolysis study) has completed accrual of its originally planned cohort of 692 patients.

Suresh Vedantham, professor of Radiology, Interventional Radiology Section, Washington University School of Medicine in St Louis, USA, and principal investigator of the trial made the announcement on behalf of its steering committee. As stated on the SIR Foundation webpage: “ATTRACT, which enrolled patients in 56 hospitals, will determine if the use of pharmacomechanical catheter-directed thrombolysis in patients with acute proximal deep vein thrombosis prevents the post-thrombotic syndrome and improves quality of life.”

“ATTRACT is more than three times the size of the only other multicentre randomised controlled trial of deep vein thrombosis thrombolysis. Combined with its strong methodological design and rigorous conduct, the successful enrollment of the entire sample should cement the credibility of the study’s results. This could not have occurred without strong community participation, including our active collaboration with SIR Foundation and a public endorsement of the study by the US surgeon general,” Vedantham is quoted as saying the SIR Foundation announcement.

ATTRACT data could change guidelines

Vedantham spoke to Interventional News in September 2014 on the latest from the paper “Quality improvement guidelines for the treatment of lower-extremity deep vein thrombosis with use of endovascular thrombus removal” after its online publication in the Journal of Vascular and Interventional Radiology (JVIR) to say: “This article represents the best consensus quality improvement tool we could develop within the bounds of existing catheter-directed thrombolysis studies, which are still quite limited in scope and methodology. We hope and expect that the next version of these guidelines will be created with the benefit of additional randomised trial data, including that from the National Institute for Health-sponsored, multicentre, randomised, assessor-blinded, ATTRACT (Acute venous thrombosis: thrombus removal with adjunctive catheter-directed thrombolysis) trial.”

Bariatric embolization is the first catheter-based procedure that attempts to directly address obesity. The minimally invasive technique is expected to decrease the hormone ghrelin, responsible for appetite, resulting in weight loss. Currently, the only proven long-term procedural solution for substantial weight loss is bariatric surgery, an often extensive operation.

A new procedure to combat obesity was performed in November 2014 by physicians at Dayton Interventional Radiology, Dayton, USA, under the supervision of lead investigator Mubin I Syed, and in conjunction with The Ohio State University Wexner Medical Center as part of the GET LEAN (Gastric artery embolization trial for lessening appetite nonsurgically) study.

Animal studies at Johns Hopkins University and Duke University, using the left gastric artery embolization technique, have shown significant ghrelin suppression and weight loss. Recently, researchers at Harvard University retrospectively noticed that patients undergoing gastric artery embolization to combat bleeding also lost 8% of their body weight, on average. The first and only other study in humans utilising bariatric embolization for weight loss was conducted in the Georgian Republic (former Soviet Union). In that 2013 study, five patients lost an average of 45 pounds within six months.

“We are combining years of scientific research on the hormone ghrelin, looking at its role with respect to appetite suppression, and combining it with an everyday type of embolization procedure that interventional radiologists routinely perform,” states Kamal Morar, one of the study’s principal investigators.

The GET LEAN study concludes in September 2015 and will collect data on safety and efficacy for those patients who are morbidly obese (defined as having a body mass index greater than 40). Qualified patients are between the ages of 22 and 65, in relatively good health and under 400 pounds. The GET LEAN study will look at changes in participants’ overall weight, changes in body mass index, changes in appetite hormone levels and at quality of life data, while measuring adverse events. This FDA supervised study was issued an investigational device exemption (IDE).

“Despite its potential, bariatric embolization is still in the experimental phase. Therefore, its safety and long-term benefit has yet to be proven.”

Teleflex has announced newly published research which reaffirms the ability of catheters protected with ARROWg+ard technology to reduce both bloodstream infections and direct costs associated with treating those infections. The peer‰Ûreviewed paper appears in the October 2014 issue of the American Journal of Infection Control.

The ARROW central venous catheter with ARROWg+ard technology outperformed the unprotected central venous catheter in both infection reduction and total cost per patient. Within the study, the protected catheter achieved a zero infection rate per 1,000 catheter days. In contrast, the unprotected device was associated with a much higher catheter-related bloodstream infection (CRBSI) rate of 8.61/1,000 catheter days (7.4% of cases). The results were statistically significant. Additionally, the antimicrobial protected catheter was also associated with prolonged CRBSI-free time compared to the unprotected catheter, including dwell times of up to 25 days without a bloodstream infection.

The study focused only on central venous catheters inserted into the femoral area. The researchers compared infection rates and cost-effectiveness of an unprotected central venous catheter versus a catheter protected with ARROWg+ard technology inserted into this infection-prone region. The research goal was to determine if the chlorhexidine/silver sulfadiazine central venous catheter could reduce bloodstream infection rates and reduce the cost of diagnosing and treating an infection.

The authors undertook the study because previous cost-effectiveness analyses of antimicrobial catheters included the cost of extended hospital stays. This cost varies widely from institution to institution and country to country, limiting the applicability of the results. For the current study, the authors included only the costs of central venous catheters, infection diagnosis and antimicrobials used to treat patients who developed infections. These direct expenses, they believed, provide a clearer picture of the ultimate cost-effectiveness of the protected, antimicrobial catheter, given its somewhat higher initial cost.

The ARROW central venous catheter with ARROWg+ard technology had sharply lower central venous catheter-related costs than those associated with the unprotected catheter. Notably, the cost of an ARROW central venous catheter with ARROWg+ard technology was 15 times less expensive than an unprotected catheter. The cost per catheter day of the protected catheter was €2.92 ± €1.77 vs. the cost of an unprotected catheter at €18.22 ± €53.13.

The study involved patients admitted to the ICU of the Hospital Universitario de Canarias (Tenerife, Spain) who received one or more femoral venous catheters. It examined a total of 254 catheters and 2,195 catheter days. Each patient’s physician made the decision about whether to use a protected or unprotected catheter and whether to insert the catheter in the femoral vein.

The study was a retrospective analysis performed and published by Leonardo Lorente and colleagues independent of Teleflex. Lorente works in the Department of Critical Care at Hospital Universitario de Canarias, Tenerife, Spain.

“We report that the antimicrobial catheter eliminated infections even though it was used in the femoral access site, which is typically associated with higher infection rates,” said Lorente. “This suggests the device might be similarly effective when used in other sites with high infection risk or with vulnerable patient populations such as immunocompromised patients.”

Lorente said the results could be helpful to other institutions, adding, “These findings may interest hospitals who are evaluating antimicrobial catheters to reduce their bloodstream infection rates. The fact that the antimicrobial catheter was shown to be cost-effective should also reassure those institutions about the economics of antimicrobial central venous catheters.”

“This study underscores the fact that hospitals can benefit by looking beyond up-front costs to total treatment costs when selecting a central venous catheter,” said Jay White, president of the Teleflex vascular access division. “In the study, the total costs of using an unprotected catheter were extremely high because of the infections and related treatment costs. In contrast, the ARROWg+ard technology improved both outcomes and cost-effectiveness. This study demonstrates that Teleflex can help hospitals protect their patients and their bottom line.”

The early results obtained using this new minimally invasive technique that uses both coil embolization and foam as a sclerosing agent were published in the journal Phlebology in December 2014. The study shows that the technique, which associates a mechanical interruption of the sapheno-femoral junction to classic sclerotherapy with no need for surgery or anaesthesia, is effective, nearly painless and appears cost-effective in a small group of patients with short follow-up.

As reported in the journal, the amount of foam used is similar to scleroembolization, but the passage of foam in the femoral vein during its injection is considerably reduced, due to the coil positioned previously. The technique allows an immediate closure of the saphenous vein trunk.

Marco P Viani, Vascular Surgery Unit, Azienda Ospedaliera Fatebenefratelli, Milan, Italy and colleagues reported the results obtained with nine patients (two women, seven men; mean age 63.5 years). While six patients presented with simple varicose veins, the other three presented with healed venous ulcers.

The technique first uses echocardiography in order to identify the sapheno-femoral junction. For five patients, the physicians inserted a straight 5F catheter (Boston Scientific) at the knee in the great saphenous vein shaft using a 5F introducer. In the other four patients, the great saphenous vein was isolated at the knee and the 5F catheter was inserted into the vein shaft without using an introducer. The next step involved placement of a standard platinum coil (0.035” fibered platinum coil, Boston Scientific) 1mm wider than the calibre of sapheno-femoral junction in standing position, under echographic control. The coil was placed 1cm below the origin of the epigastric vein, and caused the prompt occlusion of the terminal portion of the great saphenous vein, according to the authors. The last step of the single-session procedure involved scleroembolisation of the great saphenous vein with lauromacrogol 2% foam carried out through the 5-French catheter under echographic control.

Viani, the inventor of the technique, told Interventional News:”The rationale behind this new technique is analogous to radiofrequency ablation or foam sclerotherapy, which are routinely used by our group.  The mechanical interruption of the saphenous shaft improves the results of simple scleroembolisation, thus abolishing venous reflux. The technique might prove useful because it reproduces a surgical vein ligation with no need of surgical incision and anaesthesia.  Nevertheless, further studies are necessary to demonstrate the effectiveness and real advantages of one shot scleroembolization. Right now, we are trying to modify the technique by optimising the mechanical interruption of the saphenous shaft, avoiding the use of a coil.”

The researchers note that this technique allows for the treatment of varicose veins without surgery and general, spinal or tumescent anaesthesia. “Only a small amount of local anaesthetic is needed to allow the positioning of the 5-French introducer or the surgical isolation of the great saphenous vein at the knee,” they report in the paper.

The researchers compressed the patients’ legs at the end of the procedure with an elastic bandage and all patients were discharged after a short medical observation (mean time 5h). They also recommended a 30-minute walking restriction post-procedure.

“Postoperative compression was maintained until the following day. Afterwards, the patient was instructed to wear compression stockings with a class I pressure gradient (20–30 mmHg) for 15 days. All patients underwent echographic control one day, seven days, one month and three months after the procedure,” the authors wrote.

Results

Viani et al reported that occlusion of the great saphenous vein trunk was immediately obtained in all patients. The procedure was almost painless, the only pain being due to the local anaesthesia to allow access to the vein. The symptoms of varicose vein disease were resolved in every patient. At the end of the procedure all patients improved their condition. There were also no perioperative complications observed.

They further reported that the mean follow-up was three months and at this time point, complete occlusion of the great saphenous vein was maintained in eight out of nine cases. There was a recanalisation of the saphenous shaft in one patient one week after treatment and this was successfully treated with a foam injection. There were no instances of coil migration or compression of the common femoral vein at three months follow-up using ultrasonography. The follow-up also included an echographic evaluation of the deep venous system and no deep vein thromboses were observed.

Viani et al write that the costs are significantly lower with one-shot scleroembolization when compared to other endoluminal techniques, such as radiofrequency, laser ablation or other minimally invasive mechanical treatments, the mean cost of a coil being US$120.

The Cardiovascular and Interventional Radiological Society of Europe (CIRSE) has launched a new observational study that will gather data on patients with primary and secondary liver tumours treated with SIR‰ÛSpheres microspheres at specialist hospitals across Europe.

The CIRSE registry for SIR‰ÛSpheres Therapy (CIRT) has been designed to collect a large amount of data on the real‰Ûlife application of selective internal radiation therapy (SIRT), also known as radioembolization. Furthermore, the study collects extensive quality‰Ûof‰Ûlife data to learn more about the palliative aspect of SIR‰ÛSpheres microspheres. CIRT is a single‰Ûdevice registry that was developed by the society in collaboration with Sirtex Medical, the manufacturer of SIR‰ÛSpheres Y‰Û90 resin microspheres.

Previous research on SIR‰ÛSpheres microspheres has shown positive results in the treatment of liver cancer.

José Ignacio Bilbao, head of Interventional Radiology, Clínica Universidad de Navarra, Pamplona, Spain and chairman of the CIRT Steering Committee, said: “CIRSE is pleased to have developed the CIRT registry, which we believe will help the doctors who administer SIR‰ÛSpheres therapy to better understand the real‰Ûlife clinical application of SIR‰ÛSpheres microspheres throughout Europe”. He added that “our goal is to enter treatment data on over 500 patients a year from more than 20 specialist European hospitals into the new CIRT registry.”

Lombard has announced the formal opening of the company’s new cleanroom, which will enhance the global operating footprint and production capabilities of their lead product, Aorfix, to meet increased worldwide customer demand.

The state of the art facility in Didcot, UK, will be officially opened by Roger Greenhalgh, emeritus professor of Surgery, Head of Imperial College Vascular Surgery Research Group.

Part of the expansion involved significantly increasing Lombard Medical’s workforce, recruiting skilled engineers in research and development, manufacturing and quality, via a government funded sector skills work academy.  The academy was facilitated by successful partnerships with Job Centre Plus and Abingdon and Witney College to attract local people with the right aptitude and then to provide intensive training prior to candidates participating in Lombard Medical’s assessment centres.  Lombard Medical increased the production workforce by over 100% in 2014, a third of which came from the academy.

“I was lucky to be involved with Lombard Medical at their beginning and witness the high quality achieved in the expert manufacture of what we previously built in an operating theatre.  Lombard Medical’s device, Aorfix, enables the aorta to be repaired as a minor procedure with less pain for patients and low risk.  Lombard is an example of successful British innovation reaching all parts of the world,” Greenhalgh said.

Simon Hubbert, Lombard Medical CEO added:

“Having had a presence in Didcot for over 10 years, Lombard Medical are strong supporters of local talent and we are pleased to be involved in this government funded recruitment initiative, along with Job Centre Plus and Abingdon and Witney College, to identify and train local people who meet our rigorous standards.  The expansion of our manufacturing facility is a key operational milestone for Lombard Medical as we continue the strong global roll out of Aorfix.”   

Veniti has announced the first use of the Vici venous stent system in Germany. The system is used to treat venous outflow obstruction in the lower extremities. The procedures were performed by Michael Lichtenberg, head of Interventional Angiology, Klinikum Arnsberg, Arnsberg, Germany.

“We are pleased to be among the first centres in Germany to treat patients using the Veniti Vici venous stent system,” said Lichtenberg. “The first patient treated had a chronic total occlusion of the left common iliac vein. The Veniti Vici venous stent restored outflow. The addition of a dedicated venous stent to my treatment options can help patients alleviate symptoms and increase their quality of life.”

Scott Solano, president and CEO of Veniti commented, “This is an exciting time for the treatment of venous disease, venous stenting is not new but dedicated venous stents are. The Vici venous stent system was designed from concept for the venous anatomy, including crush resistance, vessel coverage, and flexibility.”

The Vici venous stent system is intended for use in veins of the lower extremities and pelvis, including the iliac and common femoral veins, in patients who exhibit symptomatic venous outflow obstruction. This condition is frequently associated with disorders of the lower extremities, such as varicose veins and venous ulcers.

CeloNova BioSciences has announced that it has received an expanded indication (CE mark) in Europe for its Embozene embolic microspheres to include the treatment of benign prostatic hyperplasia.

Prostatic artery embolization offers a minimally invasive procedure when compared to the current surgical standard of care, transurethral resection of the prostate that gives men suffering from benign prostatic hyperplasia an important treatment alternative.

Symptoms can include frequent urination, weak urine stream and a persistent feeling of having to urinate. Benign prostatic hyperplasia is a common condition in men, which increases with age. Symptomatic benign prostatic hyperplasia typically occurs in the sixth and seventh decades of a man’s life, reaching an estimated 40% of men in their 70s.

“The symptoms of benign prostatic hyperplasia can cause significant impact in a patient’s quality of life and prostatic artery embolization offers a safe and effective treatment option for men”, said Ulf Teichgraeber, director of Radiology at University Hospital, Jena, Germany.

“The expanded indication in Europe for benign prostatic hyperplasia provides continuing support to interventional radiologists and urologists working in tandem to offer men relief from the symptoms of benign prostatic hyperplasia,” said Jörg Menten, president international of CeloNova BioSciences.

“Embozene microspheres go through a sophisticated manufacturing process that ensures precisely calibrated size and shape,” said Jane Ren, chief technology officer of CeloNova BioSciences.

The results of a web-based survey designed to shed light on the practice of transarterial chemoembolization (TACE) in the UK have shown that there is a wide variation in practice with some centres using conventional TACE (with lipiodol and doxorubicin) and others using, newer drug-eluting beads.

Shueh Hao Lim from the Department of Radiology, Edinburgh Royal Infirmary, Edinburgh, UK, presented the results of the study at the British Society of Interventional Radiology (BSIR) annual meeting in Liverpool in November 2014. The senior author was Jim Gordon-Smith.

Lim made the point that evidence remains equivocal as to whether conventional or drug-eluting TACE is the superior treatment and noted that no overview of the practice of TACE in the UK is currently available.

“A web-based survey of BSIR members was carried out from December 2013 to March 2014. Questions from the survey focused on which treatment type was used as well as who was responsible for referral, treatment types, reasons for current, timing of follow-up imaging, volume of disease treated in a single session and volume of TACE performed annually,” explained Lim.

Data was obtained from 28 centres in the UK. Of these, 11 centres performed more than 50 cases annually. Fifty eight per cent of centres used drug-eluting bead TACE as their only treatment method. Twelve per cent used only conventional TACE and 23% used a combination of both methods. Seven per cent of centres currently used conventional TACE for patients not included in trials and TACE with drug-eluting beads for those enrolled in trials, and cited cost as the main reason deterring them from switching completely to the use of drug-eluting beads.

The survey also found that nearly 20% of those surveyed would treat high volume disease in a single procedure. Referrals for TACE were mostly obtained from hepatologists (50%). Respondents also revealed that 89% of centres performed their first follow-up scan within 4–6 weeks of the procedure. Nearly 90% of interventionists also disagreed with the 2011 Cochrane Library Report (Review) findings that TACE should not be used for the treatment for unresectable hepatocellular carcinoma until stronger evidence is available.

“With both forms of TACE being used in regular clinical practice in the UK, the possibility of creating a head-to-head trial between drug-eluting bead and conventional TACE is realistic,” Lim concluded.

SIR has unveiled a new brand for the society and its research organisation—SIR Foundation—reinforcing its commitment to patient-driven care and highlighting the power and potential of interventional radiology. The new logos for both organisations convey the limitless possibilities of image-guided therapies to solve the toughest medical problems. SIR’s new tagline, “The vision to heal” reflects the innovative, patient-driven care that board-certified interventional radiologists deliver through methods that result in less risk, less pain and shorter recovery time than traditional surgery.

“Interventional radiology showcases the very best of today’s medicine, bringing together clinical insight, procedural expertise and advanced image-guided technology to deliver high-quality patient care,” said SIR President James B Spies, Georgetown University Medical Center, Washington, DC, USA. “Our efforts reinforce how SIR continues to support our members as they deliver outstanding clinical care and how we will continue to do so in the years to come,” added Spies.

With the renewed focus on cost-effective, patient-driven care in the evolving health care landscape, SIR and SIR Foundation actively reaffirm interventional radiology’s role as part of the greater care team. Through the new brand, the society strengthens its identity, promoting the value that interventional radiology delivers—the same value being called for in medicine: better outcomes, less burden on the patient and innovative use of technology with clear patient benefit, noted Spies.

“Our new brand helps us to better communicate the valuable and unique role that interventional radiology has in delivering comprehensive clinical care,” said SIR executive director Susan E Sedory Holzer. “By listening to our members, this new framework also reflects the passion and dedication members have for the specialty and, more importantly, high-quality care,” added Holzer.

The new logos, re-envisioned to evoke a more contemporary look and feel, retain elements of the original society logo and maintain a reference to the specialty’s catheter-based origins. The minimally invasive, image-guided method, which reaches the source of a medical problem through a tiny skin incision, was founded in the early 1960s and today has become synonymous with modern medicine.

Straub Medical has announced that the Chinese FDA has recently approved the Straub Endovascular System with its Rotarex S and Aspirex S rotational catheter families. These endovascular rotational catheters restore blood flow in occluded blood vessels by removing occlusion material from the vessel.

Liu Changwei, vice president of the Chinese Society of Vascular Surgery, director of the Vascular Surgery Center at Chinese Academy of Medical Sciences and Peking Union Medical College Hospital, Beijing, China, said: “The Chinese FDA approval of Rotarex S and Aspirex S catheters will bring the Chinese physicians an internationally accepted, innovative and effective solution to address the challenges of arterial and venous occlusive diseases. We look forward to using the new system soon to deliver advanced and more efficient endovascular therapies to our patients.”

Lithoplasty is a novel balloon-based technology that uses integrated lithotripsy, a pulsatile mechanical energy commonly used to break up kidney stones, to disrupt both superficial and deep calcium and normalise vessel wall compliance prior to low-pressure balloon dilatation.

“Lithoplasty is a breakthrough that could revolutionise the treatment of peripheral artery disease a common circulatory problem that can lead to serious complications, including amputation,” said –Marianne Brodmann, Medical University of Graz, Austria.

“With Lithoplasty, even historically very challenging peripheral arterial disease patients with deep calcium can be treated effectively without significant injury to the vessel.”

In advanced vascular disease, atherosclerosis becomes calcified deep inside the vessel walls, obstructing blood flow. These deposits make today’s interventions challenging and prone to both procedural and long-term failure. Lithoplasty is designed to be naturally gentle on the soft, healthy, portions of the vessel, while remaining hard on difficult-to-treat calcified tissue.

Shockwave’s technology allows for low-pressure balloon dilatation, reducing the potential for soft tissue vascular injury, which is known to occur with current endovascular technologies.

The CE mark for Lithoplasty was supported by safety and utility clinical data from the multicentre DISRUPT PAD study, which was presented in November 2014 at the Vascular Interventional Advances (VIVA) Annual Conference in Las Vegas, USA. Early results demonstrated safe and effective dilatation of calcified stenosis with no acute failures, very favourable residual stenosis, no major adverse events and no restenosis out to 30 days.

Johns Hopkins researchers have developed a sugar-based molecular microcapsule that eliminates the toxicity of an anticancer agent developed a decade ago at Johns Hopkins, called 3-bromopyruvate, or 3BrPA, in studies of mice with implants of human pancreatic cancer tissue.

The encapsulated drug packed a potent anticancer punch, stopping the progression of tumours in the mice, but without the usual toxic effects.

“We developed 3BrPA to target a hallmark of cancer cells, namely their increased dependency on glucose compared with normal cells. But the nonencapsulated drug is toxic to healthy tissues and inactivated as it navigates through the blood, so finding a way to encapsulate the drug and protect normal tissues extends its promise in many cancers as it homes in on tumour cells,” says Jean-Francois Geschwind, chief of the Division of Interventional Radiology, Johns Hopkins Medicine.

Geschwind told Interventional News: “The goal of the encapsulation of the drug was to allow systemic delivery since the free formulation is too unstable to be given systemically. However, it does not mean this microencapsulated formulation cannot be used for localised delivery. In fact, we know the drug will be more effective because it will not break down through hydrolysis. As a result, the drug could be used intra-arterially, intratumourally and also intra-peritoneally to treat various types of cancer.” 

The Johns Hopkins team used a microshell made of a sugar-based polymer called cyclodextrin to protect the 3BrPA drug molecules from disintegrating early and to guard healthy tissue from the drug’s toxic effects, such as weight loss, hypothermia and lethal hypoglycaemic shock.

Geschwind, a professor in the Russell H. Morgan Department of Radiology and Radiological Science at the Johns Hopkins University School of Medicine and its Kimmel Cancer Center, and others at Johns Hopkins have been studying the experimental drug as a cancer treatment for over a decade because of its ability to block a key metabolic pathway of cancer cells.

Most cancer cells, he explains, rely on the use of glucose to thrive, a process known as the Warburg effect, for Otto Heinrich Warburg, who was awarded the Nobel Prize in Physiology for the discovery in 1931. By using the same cellular channels that funnel glucose into a cancer cell, 3BrPA can travel inside the cancer cell and block its glucose metabolic pathway, Geschwind says. However, animal studies have shown that in its free, nonencapsulated state, the drug is very toxic, says Geschwind.

The toxicity associated with the free-form version of the drug, he says, has prevented physicians from using the drug as a systemic treatment in people, one that can travel throughout the whole body. In a report about their study published online Oct. 17 in Clinical Cancer Research, the researchers described minimal or zero tumour progression in mice treated with the microencapsulated 3BrPA.

By contrast, a signal of tumour activity increased sixty-fold in mice treated with the widely used chemotherapy drug gemcitabine. Activity increased 140-fold in mice who received the drug without encapsulation. Specifically, daily injections of nonencapsulated 3BrPA were highly toxic to the animals, as only 28% of the animals survived the 28-day treatment. All of the mice who received the encapsulated drug survived to the end of the study.

Geschwind says the “extremely promising results” of the study make the encapsulated drug a good candidate for clinical trials, particularly for patients with pancreatic ductal adenocarcinoma. These cancers rank as the fourth most common cause of cancer-related deaths in the world, with a five-year survival rate of less than 5%. In the mouse studies, the encapsulated medication also reduced the metastatic spread of pancreatic cancer cells.

Commenting on the timescale of how far the researchers are from using this anti-cancer agent in humans, Geschwind said: “We have been negotiating with a group of investors to sponsor early stage clinical development. We have received the investigational new drug status from the FDA more than a year ago authorising us to start phase I trials, so as soon as the financial support is in place, we will be ready to begin.”

Kypho-IORT (Combining intraoperative radiotherapy with kyphoplasty for treatment of spinal metastases) will test a new combination treatment that delivers radiation directly to the tumour and increases support of the spine.

The phase I trial has been launched by Loyola University Medical Center, Chicago, USA.

A press release from the medical centre describes the procedure as follows: at first, an interventional radiologist makes a small incision into the spine and inserts a spinal applicator needle to deliver radiation directly to the tumour, a procedure known as intraoperative radiotherapy. Due to this procedure being more precise than standard external beam radiation, intraoperative radiotherapy can deliver a higher dose of radiation, while minimising adverse effects to normal tissue. Intraoperative radiotherapy is then followed by balloon kyphoplasty to stabilise the spine.

The release also clarifies that to be eligible for enrolment, a patient must meet several criteria, including being 50 or older and having metastatic cancer that has spread from a solid tumour to the spine.

Researchers will compare the pain levels and use of pain medications before and after the procedure. They also will monitor quality-of-life issues, the effect of the procedure on the tumour and any complications.

The principal investigator is William Small, Jr, chair of the Department of Radiation Oncology.

The Gore Viabahn Endoprosthesis has received CE mark approval to improve blood flow in symptomatic obstruction of peripheral veins, excluding the venae cavae and pulmonary veins.

“[The Gore Viabahn Endoprosthesis] has a proven track record in maintaining patency in central chest vein stenosis as confirmed by our recently published single-centre study. It is extremely flexible, allowing deployment across anatomical sites of movement and flexion. The Gore REVISE clinical study indicates improved patency compared to PTA in the graft to vein anastomosis and has demonstrated similar outcomes to draining veins, particularly at the cephalic arch, in my practice,” says Peter Riley, consultant interventional radiologist at the Queen Elizabeth Hospital, Birmingham, UK.

In the Gore REVISE clinical study (AVR 06-01), the Gore Viabahn device group demonstrated statistical superiority of target lesion primary patency as compared to PTA (p=0.008).

Gore says that the Viabahn device is the lowest profile, most flexible, self-expanding, small-diameter, endoprosthesis available. It is constructed with a durable, reinforced, biocompatible, expanded polytetrafluoroethylene (ePTFE) liner and attached to an external nitinol stent structure. The ePTFE luminal surface of the Gore Viabahn Endoprosthesis incorporates the CBAS heparin surface. This heparin technology consists of a proprietary, covalent end-point attachment to the graft surface that is intended to provide sustained thromboresistance.

The results of a new study presented at the annual meeting of the Radiological Society of North America (30 November–5 December, Chicago, USA) show that placement of internal iliac balloons is technically feasible, well-tolerated and leads to satisfactory maternal and foetal outcomes with minimal complications.

Placenta accreta, in which the placenta abnormally implants in the uterus, can lead to additional complications, including massive obstetric haemorrhage at delivery. Hysterectomy is commonly required to control such bleeding.

“Massive obstetric haemorrhage is the number one cause of maternal mortality worldwide and abnormal placental implantation is a major risk factor for this,” said Patrick Nicholson, Cork University Hospital, Cork, Ireland.

At Cork University Hospital, patients with abnormal placental implantation are treated by a multidisciplinary team that plans both an elective Caesarean (C-)section and prophylactic internal iliac balloon placement under fluoroscopic guidance. Immediately prior to the patient’s C-section, an interventional radiologist inserts balloons into the two internal iliac arteries in the pelvis that supply the uterus with blood flow.

“Following the delivery of the baby, these balloons can be inflated to slow blood flow to the uterus, which allows the obstetrician time to gain control of the haemorrhage,” Nicholson said.

Nicholson and team retrospectively reviewed the charts of all patients with abnormal placental implantation who received prophylactic internal iliac balloon placement since 2009. Over a 44-month period, the hospital treated 21 patients (mean age 35) who underwent balloon placement immediately followed by C-section.

In 13 of the 21 deliveries, the arterial balloons were inflated and when no longer needed, deflated and removed from the patient. The interventional radiology procedure was a technical success in 100% of the cases. However, despite use of the balloons, two of the patients required a hysterectomy.

“Without the balloons, many more of the patients would likely have required a hysterectomy,” Nicholson said. There were no maternal or foetal complications resulting from the interventional procedure.

“We are the first group to report on the foetal outcomes associated with prophylactic internal iliac artery balloon placement,” Nicholson said. “There were no adverse outcomes for the babies as a result of this procedure.”

According to Nicholson, the incidence of abnormal placental implantation has been increasing steadily over recent years.

“The risks for placenta accreta and its variations increase with a woman’s age, previous C-sections and in vitro fertilisation, all of which we expect to see more of in the coming decades,” he said. “There is clearly a need for more research in this field.”

Nicholson noted that results of the study add to a growing body of evidence that high-risk placental implantation pregnancies are best managed in a multidisciplinary setting. “This research highlights the value of interventional radiology in managing this very serious, high-risk condition to control bleeding and maternal and foetal complications,” Nicholson said.

Lombard Medical has released efficacy and safety data from the two-year follow up of the US PYTHAGORAS pre-marketing approval (PMA) trial of Aorfix, the first and only endovascular stent graft with global approvals for the treatment of patients with aortic neck angulations up to 90 degrees.

The data were presented by Mark F Fillinger, principal investigator of the Aorfix PYTHAGORAS trial, director of vascular surgery training programmes, and professor of surgery at Geisel School of Medicine, Dartmouth, at the VEITHsymposium (18-22 November, New York City, USA). They showed 100% freedom from aneurysm rupture, 98% freedom from type I and type III endoleaks and 99% freedom from device migration in patients with a 60 to 90 degree aortic neck angulation, a group typically considered difficult-to-treat and associated with poor treatment outcomes.

Other key findings from the two-year data included 98.2% freedom from abdominal aortic aneurysm-related mortality and 97.2% freedom from graft occlusion in patients with neck angles between 60 to 90 degrees. Lombard Medical also presented results evaluating the use of Aorfix in patients with tortuous iliac anatomy who may be at increased risk of iliac limb occlusion and other complications, which are commonly caused by kinking, migration or dislocation of a stent graft, or extension of the graft into the external iliac artery.

The data, presented by Brian R Hopkinson, co-inventor of Aorfix and emeritus professor of vascular surgery at University of Nottingham and consultant vascular surgeon at Queen’s Medical Centre, UK, found that despite distinct changes in iliac angulation resulting from aneurysm regression (reversal) after endovascular aneurysm repair, the incidence of iliac-related complications did not increase and remained low.

“Aorfix is uniquely designed to treat patients with highly-angulated necks and yield consistently positive treatment outcomes in both challenging and more typical cases involving patients with angulations below 60 degrees,” said Simon Hubbert, chief executive officer of Lombard Medical.

Both data analyses were derived from the PYTHAGORAS study, which formed the basis of the FDA approval of Aorfix. The controlled, prospective, non-randomised, multicentre study evaluated 218 patients, a majority of whom had neck angles between 60 to 90 degrees. Lombard Medical anticipates publication of the two-year outcomes in 2015, and will continue to collect data on effectiveness and safety for up to five years post-implant.

Silk Road Medical’s 30-day outcomes from the ROADSTER IDE study were presented at the Late Breaking Clinical Trials Session at the 2014 Vascular InterVentional Advances (VIVA) Meeting in Las Vegas, with additional data presented at the VEITHsymposium in New York.  

The trial studied the Enroute transcarotid neuroprotection system (NPS), which is designed to provide direct access to the carotid artery and reduce the risk of stroke during carotid angioplasty and stenting (CAS) by diverting dangerous debris away from the brain with a surgically-inspired mechanism to temporarily reverse blood flow. The 1.4% 30-day stroke rate was the lowest seen to date of any contemporary prospective trial of CAS. 

Celebrating its 60^th anniversary in 2013, carotid endarterectomy (CEA) has been the gold standard in carotid artery revascularisation because of the low stroke and death rates in multiple prospective trials. Yet CEA is not free of the potential for certain local and systemic complications such as cranial nerve injury and myocardial infarction.

Fifteen years ago transfemoral CAS was introduced with much initial excitement due to the minimally invasive, endovascular advantage, but fell out of favour for physicians and payers due to the excess risk of periprocedural stroke compared to CEA. In a standard surgical risk population, the CREST trial demonstrated that periprocedural strokes occur twice as often in transfemoral CAS patients.

ROADSTER was a prospective, multicentre, IDE study designed to evaluate the safety and effectiveness of the Enroute transcarotid NPS in a hybrid procedure combining the best elements of CEA and CAS. Richard Cambria and Christopher Kwolek, of Massachusetts General Hospital, served as the trial national co-principal investigators. Patients were enrolled at 15 vascular surgery sites, one neurosurgery site, and two multi-specialty sites. The primary endpoint was a composite of any stroke (S), death (D), or myocardial infarction (MI) through 30 days.

Two-hundred and eight (67 lead-in, 141 pivotal) symptomatic and asymptomatic patients who were at high risk for complications from CEA were enrolled. Food and Drug Administration (FDA)-approved carotid stent systems were delivered through the direct carotid access point under high rate flow reversal afforded by the Enroute transcarotid NPS. Baseline pivotal population characteristics included 26% symptomatic, 35% female, and 47% age greater than or equal to 75. 

There were no strokes in patient’s age greater than or equal to 75 or in symptomatic patients. There was one (0.7%) CNI presenting as hoarseness which fully resolved. 

“These stroke rates in a high surgical risk population are the lowest to date for CAS and comparable to the periprocedural rates in the standard surgical risk CEA arm of CREST (2.3%). The Silk Road procedure is less of an operation for the patient than a traditional CEA and can be performed in under an hour with local anaesthesia,” Cambria explains.

Erica Rogers, chief executive officer of Silk Road Medical, says: “The ROADSTER data support our hypotheses that led to this device design and procedure. It is all about stroke. Doctors perform these procedures to reduce the risk of stroke, not to cause a stroke. The ENROUTE transcarotid platform finally delivers a less invasive alternative with the neuroprotection you would expect from a CEA procedure.”

The Enroute NPS and Stent Systems are limited by United States law to investigational use; the Enroute transcarotid NPS has been submitted for 510(k) review and the ROADSTER trial also supports the pending Premarket Approval PMA for the Enroute transcarotid Stent System. The Enroute transcarotid NPS and the Enroute transcarotid Stent System have been granted CE mark.

The first large-scale, multispecialty prospective clinical research trial to evaluate the use of inferior vena cava (IVC) filters and related follow-up treatment in the USA – initiated by a collaboration between the Society of Interventional Radiology (SIR) and the Society for Vascular Surgery (SVS) – is set to enrol the first patient in spring 2015 with participation from seven filter manufacturers.

Predicting the Safety and Effectiveness of Inferior Vena Cava Filters (PRESERVE) will directly address an August 2010 FDA medical alert detailing the possibility that retrievable IVC filters could move or break, potentially causing significant health risks for patients. SVS and SIR collaboratively formed the IVC Filter Study Group Foundation, a not-for-profit entity that sponsors and oversees PRESERVE. The study will have the goal of obtaining a real world view of the safety and effectiveness of most filters placed in the USA.

“The PRESERVE study will benefit patients by helping determine how well filters prevent pulmonary embolism and when retrievable filters should be removed,” notes Peter Lawrence, foundation vice president.

Filter manufacturers are providing financial support to the IVC Filter Study Group Foundation to sponsor the PRESERVE study. The manufacturers and devices that will be included in the study are ALN Implants Chirurgicaux (ALN Vena Cava Filters); Argon Medical Devices (Option Elite Retrievable Vena Cava Filter designed and manufactured by Rex Medical); B Braun Interventional Systems (VenaTech LP Vena Cava Filter); Bard Peripheral Vascular (DENALI Vena Cava Filter System); Cook Incorporated (Cook Günther Tulip Vena Cava Filter); Cordis Corporation (Cordis OptEase Retrievable Vena Cava Filter/ Cordis TrapEase Vena Cava Filter); and Volcano Corporation (Crux Vena Cava Filter System).

The five-year study will evaluate the overall safety and efficacy of filters placed by doctors and intends to enrol 2,100 patients at approximately 60 centres in the USA. There will be at least 300 patients enrolled for each participating manufacturer filter, and patients will be evaluated every six months post-procedure up to 24 months or filter retrieval. Principal investigators are Matthew S Johnson, Indiana University School of Medicine, Indianapolis, Indiana, and David L Southcoast Health System, Fall River, Massachusetts.

Protocol development has been completed, and an investigational device exemption study with Health Insurance Portability and Accountability Act compliance has been granted by the FDA. Members of the IVC Filter Study Group Foundation have been working with the contract research organisation New England Research Institutes, and it is expected that the first patients may enrol in spring 2015.

According to the US Surgeon General, between 350,000 and 600,000 people each year in the USA are affected by blood clots and between 100,000 and 180,000 people die of pulmonary embolism each year. The FDA recommends that physicians remove the filters, which are designed to be retrievable, once the threat of pulmonary embolism has passed. The FDA warning said that all physicians were encouraged to consider the benefits and health risks of IVC filter removal for each patient.

Hansen Medical has announced the completion of the first robotic prostatic artery embolisation (PAE) in the USA. Sandeep Bagla, interventional radiologist, performed the procedure at Inova Alexandria Hospital in Alexandria, Virginia using the Magellan robotic system.

Benign prostatic hyperplasia (BPH), or enlargement of the prostate, is a common condition that affects over 50% of men aged 50 and as high as 80% of men aged 80 or older. The continued enlargement of the prostate gland can lead to difficulties associated with the bladder and urination. Sufferers of BPH may experience a diminished quality of life as sleep is often interrupted by a frequent need to urinate during the night. If untreated, BPH can lead to complications including a weakened bladder, blockage, bladder stones or infections.

PAE is a therapy in which the size of the prostate is reduced by a less invasive catheter-based approach that works to reduce blood flow to the main arteries that feed the prostate. Successfully performed, prostatic artery embolisation can reduce the prostate gland size and eliminate the symptoms associated with BPH. Currently a patient must choose between long-term medical therapy or highly invasive surgical options that may often result in complications such as pain, bleeding, incontinence or impotence. Some sources have estimated that almost 2 million men did not seek therapy last year because of the potential complications that can result from a traditional surgical approach.

The Magellan system is an advanced technology that drives the Magellan Robotic Catheters during endovascular procedures. Magellan is designed to offer procedural predictability, control, and catheter stability to physicians as they remotely navigate the robotic catheter through the vasculature. Magellan’s remote workstation allows physicians to navigate through the vasculature while seated away from the radiation field, potentially reducing physicians’ radiation exposure and procedural fatigue.

The Magellan 6Fr Robotic Catheter received FDA 510(k) clearance earlier this year and is commercially available in the USA.

Covidien has announced the six-month results of the VeClose pivotal study, which demonstrated the safety and effectiveness of the VenaSeal closure system in patients with chronic venous insufficiency (CVI) having symptomatic reflux in the great saphenous vein. The results were presented at American College of Phlebology Annual Congress (ACP 2014; Phoenix, USA).

The VeClose randomised controlled non-inferiority study compared the safety and effectiveness of the VenaSeal system to that of the ClosureFast endovenous radiofrequency ablation catheter. Covidien’s ClosureFast catheter is an endovenous radiofrequency (RF) ablation catheter designed to collapse and close enlarged leg veins. The VenaSeal system, which is not approved and currently limited to investigational use in the United States, is a minimally invasive procedure that uses a specially formulated medical adhesive to close the great saphenous vein. Additionally, the VenaSeal system eliminates the need for surgery, thermal ablation and tumescent anaesthesia.

“The VenaSeal system is the latest innovation in the evolution of minimally invasive treatment options for chronic venous disorders,” says Nick Morrison, co-national principal investigator for the VeClose study. “The six-month results of the VeClose study showed high closure rates, comparable to radiofrequency ablation. I am excited about the possibility of offering this tumescent-free treatment option to patients.”

Two hundred and forty-two patients were enrolled in the trial, of which 108 were randomised to receive treatment with the VenaSeal system and 114 with the ClosureFast catheter. Twenty patients were enrolled as roll-in/training cases and treated with the VenaSeal system. The results showed outcomes for the VenaSeal system comparable with the excellent closure rates associated with the ClosureFast catheter and demonstrated non-inferiority of the VenaSeal system:

• At three months, the complete closure of the great saphenous veins achieved in more than 98.9% of patients treated with the VenaSeal system compared to 95.6% of patients treated with the ClosureFast catheter.
• The closure rate at six months was 98.9% and 94.3% for the VenaSeal system and the ClosureFast catheter, respectively.
• Additionally, there were no significant differences in patient reported pain during or at three days post procedure between the groups.

Additionally, in October 2014, the Journal of Vascular Surgery published results from the European Sapheon closure system observational prospective (eSCOPE) study, which demonstrated significant improvement in venous symptoms with a cumulative 12 month closure rate of 92.9%. The results also demonstrated the VenaSeal system improves patients’ quality of life.

The VenaSeal system is currently approved in Australia, Canada, Europe and Hong Kong, and more than 2,000 patients have been treated with the system. The VenaSeal closure system is not approved in the United States, and is currently limited to investigational use.

This new data reveals the importance of access to 24/7 interventional radiology and the need to ensure availability of interventional radiologists in emergency care. There is a wide variation in the availability of 24/7 interventional radiology across the UK, which means that patients in some parts of the country do not receive the benefits of minimally invasive modern medicine in the emergency setting.

Leading interventional radiologists in the UK presented a unique snapshot of 24/7 interventional radiology in acute hospital care at the British Society of Interventional Radiology (BSIR) Annual Meeting (12–14 November, Liverpool, UK). This new data reveals a fascinating picture of the importance of access to 24/7 Interventional Radiology and the need to ensure availability of interventional radiologists in emergency care.

Seven major hospital sites took part in this innovative study including Hull, Manchester, Glasgow, Royal Devon and Exeter, Nottingham, St Georges and Sheffield.  The results will form part of a debate at the BSIR’s 27^th Annual Meeting in Liverpool, exploring the challenges of providing a 24 hour Interventional Radiology service and the subsequent need to develop the interventional radiology workforce of the future. The session was chaired by Neil Carmichael MP and chair of the All Party Parliamentary Group on Vascular Disease. 

The pilot study titled “7 days 7 sites 24/7 Interventional Radiology” recorded data over the course of a week from seven UK hospital sites providing acute interventional radiology care. In total, 63 cases in which interventional radiology was successfully performed were recorded as part of the audit and including

• An endovascular aneurysm repair for a 62-year-old male patient
• Embolization to achieve haemostasis in a 22-year-old patient with post-partum haemorrhage
• Insertion of a colorectal stent to successfully clear a large bowel obstruction avoiding the need for immediate surgery for a male patient
• Patient given successful dialysis within hours of emergency interventional radiology treatment for end stage renal failure and vascular access 

 
Experts hope that the study will reinforce the diversity and importance of interventional radiology as central to the provision of acute hospital care and how, if used more effectively, patient outcomes could be improved. However, a national survey in England (2012) showed that 45% of hospital sites in England do not have local or formal access to “round the clock” Interventional Radiology.   In addition, the Centre for Workforce Intelligence (England) estimates that the health care workforce is short by over 200 Interventional Radiologists. 

Iain Robertson, consultant interventional radiologist and past president of the BSIR, who led the study says, “There is a widely acknowledged challenge in providing access to 24/7 interventional radiology. We need to work further to develop equity of access and ensure the best patient outcomes. However, getting universal access to interventional radiology will be very challenging given that there is a major under-provision of interventional radiologists in the UK.  In the medium-term, we need to expand the trainee numbers in interventional radiology substantially but this workforce will take 5–10 years to come through training and make an impact.  In the short-term, we need to utilise resources more effectively across hospital networks and ultimately this will need central leadership from the NHS.

“We hope that results of the audit will trigger some interesting debate amongst experts at BSIR’s Annual Meeting and help to influence those designing and delivering acute hospital services in the future.”

Boston Scientific hosted an Industry Technological Workshop session with Neil Carmichael MP called ‘Stand and Deliver – The Challenges of Providing emergency interventional radiology treatment’. Neil Carmichael MP also spoke at the BSIR Meets Parliament session as part of the main BSIR Annual Meeting on 12 November. 

Iain Robertson, consultant interventional radiologist and past president of the BSIR, who led the study says, “There is a widely acknowledged challenge in providing access to 24/7 interventional radiology. We need to work further to develop equity of access and ensure the best patient outcomes. However, getting universal access to interventional radiology will be very challenging given that there is a major under-provision of interventional radiologists in the UK.  In the medium-term, we need to expand the trainee numbers in interventional radiology substantially but this workforce will take 5–10 years to come through training and make an impact.  In the short-term, we need to utilise resources more effectively across hospital networks and ultimately this will need central leadership from the NHS.

“We hope that results of the audit will trigger some interesting debate amongst experts at BSIR’s Annual Meeting and help to influence those designing and delivering acute hospital services in the future.”

Boston Scientific hosted an Industry Technological Workshop session with Neil Carmichael MP called ‘Stand and Deliver – The Challenges of Providing emergency interventional radiology treatment’. Neil Carmichael MP also spoke at the BSIR Meets Parliament session as part of the main BSIR Annual Meeting on 12 November. 

Lazarus Effect has announced that the Lazarus Cover accessory device has received CE mark. The Lazarus Cover is a nitinol-mesh cover that surrounds a retriever device and captured material during removal from a blood vessel.

“The Lazarus Cover provides a unique solution to what has been a major limitation of current retrieval systems, and it does so without requiring physicians to switch from their favourite stent or other retriever device,” says Martin Dieck, chairman and chief executive of Lazarus Effect. “It is among a series of disruptive devices Lazarus Effect is developing to overcome longstanding challenges associated with current vascular interventional procedures.”

Stent-based thrombectomy devices have demonstrated success in ‘capturing’ clots within an affected blood vessel, but often lose thrombus as the device is extracted. Recent results from a 500-patient, multi-centre, randomised European ischaemic stroke trial (MR CLEAN), presented at the 9th World Stroke Congress in Istanbul, revealed that direct vascular intervention (97% used retrievable stents) generated better outcomes than standard stroke therapy alone. The study also demonstrated that, despite generating better outcomes for patients, there is still room for improvement in vascular intervention. Clot particles were lost during interventional procedures, resulting in an ischaemic stroke to a new region of the brain 5.6% of the time, vs. 0.4% of the time in the control (i.e., standard therapy) group.

Lazarus Effect plans to launch the Lazarus Cover, which can be used with a variety of available retriever devices, in Europe during Q1 2015.

The US Patent and Trademark Office recently issued a new patent covering core technology behind the Lazarus Cover, as well as the Lazarus ReCover device. The Lazarus Cover is a generalised device and can be used with a number of retriever types, whereas the ReCover is designed specifically for the retrieval of thrombus during an ischaemic stroke.

Medtronic’s IN.PACT Admiral drug-coated balloon, used for the treatment of peripheral artery disease in leg arteries above the knee, provided a consistently favourable treatment effect in patients with diabetes in a landmark study of the investigational medical device, which is under review by the US Food and Drug Administration (FDA) for approval. 

This finding comes from a pre-specified subgroup analysis of patients with diabetes in the IN.PACT SFA trial that was presented at the Vascular InterVentional Advances 2014 (VIVA 14) meeting during a late-breaking clinical trials session by Peter Schneider, chief of vascular surgery at Kaiser Foundation Hospital in Honolulu.

“Peripheral artery disease in patients with diabetes tends to be more advanced and complex and, as a result, more challenging to treat than it is in patients without diabetes,” explains Schneider, a principal investigator of the IN.PACT SFA trial. “While that tendency held true in this study, diabetes did not negate the magnitude of the difference in treatment effect. The patency rates were statistically significantly higher, by more than 20%, for all patients in the drug-coated balloon arm and for its diabetic patient subset.”

The IN.PACT SFA trial enrolled 331 subjects at 57 sites across Europe and the USA. All study subjects were randomised to treatment with the drug-coated balloon (DCB) or percutaneous transluminal angioplasty (PTA). Key outcomes from all patients in the IN.PACT SFA trial were presented for the first time in April 2014 at the Charing Cross International Symposium in London and will soon be published in a peer-reviewed medical journal.

The clinically driven target lesion revascularisation (CD-TLR) rates at 12 months were 2.4% for the drug-coated balloon group and 20.6% for the percutaneous transluminal angioplasty group (p<0.001), a highly statistically significant difference. CD-TLR accounts for repeat procedures due to recurrent symptoms related to the treated lesion.

Per protocol, primary patency rates were assessed at 12 months of follow-up and showed a highly statistically significant difference: 82.2% for the drug-coated balloon group and 52.4% for the percutaneous transluminal angioplasty group (p<0.001). Primary patency at 360 days was also calculated by Kaplan-Meier survival estimates; at this specific time point, it was 89.8% for the drug-coated balloon group and 66.8% for the PTA group. Primary patency means a restoration of adequate blood flow through the treated segment of the diseased artery.

Study subjects were well matched at the time of enrolment. The vast majority (approximately 95%) of the patients had moderate or severe claudication, a condition characterized by leg pain while walking due to restricted blood flow through the superficial femoral artery or proximal popliteal artery. The remaining 5% suffered from rest pain because of more advanced arterial disease.

In addition to disease severity, other baseline characteristics – including diabetes (40.5% vs. 48.6%) and hypertension (91.4% vs. 88.3%), as well as mean lesion length (8.94cm vs. 8.81cm) and percent of total occlusions treated (25.8% vs. 19.5%) – were similar between the two groups, with no statistically significant differences. Clinical outcomes, however, significantly favoured the drug-coated balloon group.

The IN.PACT Admiral drug-coated balloon received the CE mark in 2009 and has been used in standard clinical practice in Europe since. It remains an investigational medical device in the United States, pending FDA approval.

Five-year results from the largest and longest-running clinical trial of a drug-eluting stent for treating peripheral arterial disease confirmed long-term patency for patients treated with Zilver PTX (Cook).

The results were presented by Michael Dake, Stanford University School of Medicine, Stanford, USA,at the 2014 Vascular Interventional Advances (VIVA) meeting.

Data from the Zilver PTX randomised controlled trial of paclitaxel-eluting stents for femoropopliteal disease showed five-year primary patency of 66.4% percent in the superficial femoral artery for patients treated with the paclitaxel-eluting stent. This compares to 43.4% patency for patients with balloon angioplasty or provisional bare metal stent placement.

“At five years, Zilver PTX demonstrated a 48% reduction in reintervention and a 41% reduction in restenosis compared to standard care [angioplasty],” Dake told the VIVA audience. “Five-year data for Zilver PTX vs. bare metal stenting confirm a more sustained benefit for the paclitaxel-eluting stent.”

“Cook’s commitment to providing clinical evidence of the effectiveness of drug-eluting devices in the peripheral vessels is substantial. With this new data showing durable patency at five years, we are confident our Zilver PTX stent offers peripheral arterial disease patients a lasting benefit,” said Mark Breedlove, vice president and global leader of Cook Medical’s Peripheral Intervention clinical division.

The Zilver PTX randomized trial of paclitaxel-eluting stents for femoropoliteal artery disease was a 479-patient multicentre, prospective, randomised study. 

A study that examined the incidence of cerebral microembolization and silent cerebral infarction after thoracic endovascular aneurysm repair (TEVAR) concluded that two-thirds of patients undergoing MRI had evidence of silent cerebral infarction­—a previously unrecognised burden. 

This implies that the risk of cerebral injury following TEVAR is higher than is presently recognised, the researchers pointed out.

Anisha H Perera, Vascular Surgery, Imperial College London, London, UK, presented the results of the study, which investigated the incidence of cerebral microembolization and silent cerebral infarction in patients undergoing TEVAR at CIRSE 2014.

“Overt clinical stroke occurs in 2–8% patients undergoing TEVAR. Silent cerebral infarction, a brain injury detected incidentally on imaging, is now recognised to contribute to cognitive decline and as a predictor of future stroke, dementia and depression,” the authors wrote in the abstract.

Perera and colleagues evaluated preoperative CT aortograms for aortic atheroma graded 1–5. They also performed an intraoperative transcranial Doppler of bilateral middle cerebral arteries to identify microembolic events. A subgroup underwent pre- and postoperative cerebral MRI to identify silent cerebral infarction. The study included data from 25 patients, 16 of whom TEVAR only; a further three underwent TEVAR and a carotid-subclavian bypass and six patients underwent arch/visceral hybrid procedures.

The results showed that microemboli were detected in all cases, and more frequently a) in patients with severe aortic atheroma (grade 4–5; p=0.02); b) left middle cerebral artery compared to right (p=0.003) and (c) treatment /stent graft-related compared with diagnostic wire/catheter passage (p=0.001).

Stent-graft deployment generates high numbers of microemboli

Perera told delegates that the researchers had identified microemboli per procedural step. There were seven median emboli (interquartile range 4–17) associated with wire usage; 20 (9–33) with catheter manipulation; 34 (17–101) with contrast injection; four (3–8) with stent-graft insertion; 12 (2–28) with stent graft manipulation,); 50 (24–141 with stent graft deployment; and four (2–7) with device removal.

There were two post-operative strokes (8%), and silent cerebral infarction was observed in two- thirds (8/12) patients undergoing MRI.

“This study has identified high-risk patients and procedural phases, which will determine future strategies to minimise cerebral injury,” Perera told delegates.

“By prompting more questions than it provides answers, this interesting study opens our eyes to the wide range of opportunities to better understand the range and importance of the risks and limitations of current thoracic aortic interventions,” said Michael Dake, Stanford University School of Medicine, Stanford, California, USA .

The upcoming British Society of Interventional Radiology (BSIR) Annual Meeting (12– 14 November 2014 BT Convention Centre, Liverpool, UK) will present a snapshot audit titled “7 days, 7 sites, 24/7 Interventional Radiology” with data recorded over the course of a week from seven UK hospital sites providing acute interventional radiology care.  

This new data aims to demonstrate the diversity and importance of interventional radiology as central to the provision of acute hospital care and how, if used more effectively, patient outcomes could be vastly improved. 

Additional key scientific sessions will cover evidence-based interventional radiology, mult-disciplinary team discussions for malignant liver lesions, aortic, peripheral, hepatobiliary, embolization and interventional oncology. 

The BSIR will also host a session titled “BSIR Meets Parliament” chaired by Neil Carmichael MP and Chair of the All Party Parliamentary Group on Vascular Disease, with Fiona Miller, Peterborough, UK, giving an update on the National Vascular Registry and Simon McPherson, Leeds, UK, presenting the results of the NCEPOD (National Confidential Enquiry into Patient Outcome and Death) review of lower limb amputation.

Duncan Ettles, Hull, UK, and president of the BSIR, says; “We are excited to have such a diverse programme for the 27th Annual Meeting of the society and look forward to welcoming delegates to share their experiences of interventional radiology in practice from across the UK and internationally.  As a Society, we are keen to promote increased interest in research and evidence-based radiology to improve patient outcomes – and we envisage that the opening plenary session will stimulate interesting debate that will resonate with current interventional radiology practitioners as well as future generations of practitioners. ” 

Anthony Watkinson, Exeter, UK, will deliver this year’s key note speech—the Wattie Fletcher lecture and Jon Moss, Glasgow, UK, will receive the BSIR Gold Medal.  The conference will close with a prize-giving session including winners of the 2014 Terumo Scholarships and the BSIR 2014 Oral and Poster Presentation Prizes.

Hansen, has announced that the Magellan 6F robotic catheter has received CE marking for use in the peripheral vasculature, allowing the company to market the catheter in Europe and other countries.

The 6Fr Robotic Catheter’s new dual-bend technology enables independent robotic control of two separate bend sites on a single catheter, providing for precise robotic navigation and control. The small 6Fr outer diameter enables use of the Magellan Robotic System in smaller vessels in the peripheral vasculature and broadens use of intravascular robotics technology to physicians who may prefer a smaller diameter vessel insertion site.

“This is a significant milestone in the development of intravascular robotics,” said Mo Hamady, Imperial College London. “Robotic catheters have the potential to provide physicians with enhanced control and navigation, especially in tortuous vessels. With this smaller-diameter robotic catheter, we can now broaden the types of procedures we are able to perform with the Magellan robotic system. The new 6F robotic catheter increases the clinical applications to many interventional vascular therapies involving smaller vessels, including cancer treatment, women’s health, and lower limb treatment.”

Magellan is designed to offer procedural predictability, control, and catheter stability to physicians as they remotely navigate the robotic catheter through the vasculature. Magellan’s remote workstation allows physicians to navigate through the vasculature while seated away from the radiation field, potentially reducing physicians’ radiation exposure and procedural fatigue.

The Magellan 6F robotic catheter received FDA 510(k) clearance earlier this year and is commercially available in the USA.

Spectranetics and Covidien have announced a definitive agreement under which Spectranetics will acquire Covidien’s Stellarex drug coated angioplasty balloon platform for US$30 million.

The transaction is subject to approval by the Federal Trade Commission and other regulatory agencies, as well as closure of the pending acquisition of Covidien by Medtronic, which is expected to occur in early 2015.

It is anticipated that the Stellarex drug coated angioplasty balloon platform will receive European CE mark approval in late 2014 or early 2015. Spectranetics expects a European launch of the product immediately upon CE mark approval, with US commercialisation in the 2017 timeframe, following FDA approval, a press release from Spectranetics states.

“This acquisition advances Spectranetics’ objective to provide comprehensive solutions to cross, prepare and treat the most complex vascular conditions,” said Scott Drake, president and CEO, Spectranetics. “Drug coated balloons are and will be an integral part of the vascular landscape for many years to come. Global thought leaders believe that primary patency is the most important clinical metric, and Stellarex’s feasibility data stands apart. We believe this technology will meaningfully add to our near-term revenue growth and expand operating leverage over time.”

“The Stellarex team has made significant progress developing this advanced technology and we are confident that Spectranetics is the right organisation to advance the programme,” said Brian Verrier, president, Peripheral Vascular, Covidien. “Pending completion of the Medtronic transaction, Covidien looks forward to collaborating with Spectranetics to transfer this technology as well as ensure investigators of the ILLUMENATE trial series are transitioned appropriately.”

The Stellarex drug coated balloon platform is designed to treat peripheral arterial disease. Stellarex uses EnduraCoat technology, a durable, uniform coating designed to prevent drug loss during transit and facilitate controlled, efficient drug delivery to the treatment site. The platform currently is not approved for sale in any market.

About ILLUMENATE first-in-human study

Data from the ILLUMENATE first-in-human study was reported at the EuroPCR Scientific Congress in May 2014. The study is a prospective, multicentre, single-arm study designed to assess the clinical performance of the Stellarex drug coated balloon. In the study, 58 superficial femoral and/or popliteal lesions (up to 15 cm in length) in 50 patients were pre-dilated with an uncoated angioplasty balloon, followed by treatment with the Stellarex DCB. Clinical events were adjudicated by independent angiographic and sonographic core laboratories. The study found the Stellarex drug coated balloon to be safe, with durable results to 24 months reported on 44 patients, including:

•          Primary patency (defined as the treated artery remaining open without further treatment required or renewed blockage detected by ultrasound scanning) was 89.5% at 12 months and 80.3% at 24 months.
•          Freedom from clinically driven target lesion revascularisation at 24 months was 85.8%
•          No amputations or cardiovascular deaths were reported.

There is a compelling case for the medical community, including the device industry, to develop specific devices that are appropriate for paediatric patients. Paediatric interventional radiologists often have to “make do” and be creative in order to treat children whilst using devices that are designed for and tested on adults only. The need for appropriate devices for the paediatric population ranges from the common and simple, such as long-term feeding tubes and vascular access devices, to the expensive and biomechanically complex, such as bioabsorbable stent-grafts, say opinion leaders in the field.

There are many factors that make it difficult to tailor devices to paediatric patients (who range from neonates to teenagers) and who need devices that remain suitable and effective as the patients grow. Still, paediatric interventional radiologists see a real need for children-specific kits and are calling for incentives within the medical device industry to help drive testing and modifications for children, in order to improve patient care.

Alex Barnacle, consultant interventional radiologist, Department of Radiology, Great Ormond Street Hospital for Children, London, UK, told Interventional News: “There are almost no paediatric-specific interventional radiology devices available, other than intravenous access devices. There is a modified paediatric version of a transjugular liver biopsy set available, which is still too large for use in small children, and a paediatric transjugular intrahepatic portosystemic shunt (TIPS) set, but otherwise most devices are only available in adult sizes.”

Daniel Sze, professor, Interventional Radiology with his colleagues Matthew Lungren, assistant professor and F Glen Seidel, clinical professor from the Lucile Packard Children’s Hospital, Stanford University, Stanford, USA, said, “There are very few devices specifically tailored for children, and this is a glaring unmet need for paediatric interventional radiology. However, there has been significant movement in the interventional marketplace to optimise intravascular devices for smaller and smaller size vessels as the demand increases in the adult interventional marketplace (ie. below the knee and retrograde revascularisation procedures, radial artery access); in fact, some basic interventional tools are already maximally miniaturised (needles, wires, microcatheters). For the most part, however, adult devices continue to be the only available devices for use in children, leaving few, if any, paediatric specific device options. 

Carlos J Guevara, Instructor of Radiology, Washington University School of Medicine, Mallinckrodt Institute of Radiology, St. Louis, USA, echoes their views. “Most devices are made for adult patients and therefore in many circumstances we have to get creative and use whatever tools we have available to us. I do not think there are enough adequate interventional radiology devices for use in paediatric patients and that includes common devices such as central vein catheters as well as more advanced devices such as transjugular biopsy needles and thrombolysis catheters,” he said.

Most needed devices

While there are several different types of devices that need to be tailored to provide better care for paediatric patients, some of the most apparent ones include devices for central vein access, transvenous biopsy, enteral access, fluid drainage, and endovascular procedures. 

“One of the biggest challenges is finding suitable long-term feeding tubes for small children. The small calibre gastrojejunal tubes needed in young children are simply not available, and this means that small children have to either continue to have uncomfortable nasojejunal tubes for several years or we have to place large calibre 16Fr feeding devices, which are really unsuitable for children who are only a few kilograms in weight,” Barnacle pointed out.

In Guevara’s view, “Two of the most common procedures done in paediatric patients are central line placement for venous access and drain placement for abscesses. Most of the catheters are designed for adult patients and the lines or catheters have to be positioned and covered so that they are not at risk from being pulled out inadvertently by children. In some instances there is a lot of redundancy of the device outside of the body which makes it difficult for the patient, the family, and the healthcare workers who have to work with the catheters.”

Sze and colleagues also make the case for low dose (high quality) fluoroscopy. “Dose awareness has reached a peak in other modalities such as CT, but still lags somewhat in the interventional fluoroscopic suite. There are major advances on the horizon by the major manufacturers, who are close to achieving clinically advanced low-dose fluoroscopy and digital subtraction angiography without compromising image quality.

“For devices, one major area that the community hopes to see movement in is bioabsorbable medical device platforms, such as vascular stents. Other areas that need more attention include vascular access devices such as peripherally inserted central catheters (PICCs) and gastrostomy and gastrojejunal tubes. For vascular procedures, lower profile angiographic catheters of similar shapes and performance as adult models are needed,” they outlined.

Difficult patients

Paediatric interventionalists expound that there are both inherent and external challenges to paediatric devices—for example, the biology of growing bodies is a taxing environment for permanent implantable devices. In addition, available data in adult patients may not accurately predict outcomes in children. From a technical point of view, it is their small size that can be a challenge. “The bodies of paediatric patients can be quite small and it can be challenging to adapt to carrying out a procedure in children for this reason. For example, some veins in children can be just a few millimetres wide and it can be difficult to get access. Also, since most of the equipment and devices are made for adults, this can add to the complexity of making these work when you have a small patient. For instance, when you have equipment that is designed for use in large adults (such as enteral access kits to place gastrostomy and gastrojejunostomy tubes), it is quite challenging to then use this same equipment for children,” said Guevara.

Another aspect to be considered is the type of anaesthesia needed to carry out interventional radiology procedures in children. “Most interventional radiology procedures in adults are done using moderate sedation, and that is not possible for most paediatric patients. Anaesthesia collaboration is necessary, which adds another layer of complexity,” he continued.

Barnacle agreed: “Many children are frightened when they come into hospital and can be uncooperative because of fear or because of their limited level of understanding of what is happening to them. So paediatric units have to have far more capacity for sedation and general anaesthesia cases, and this is not always easy to achieve.

Sze and colleagues point out that “With very few exceptions, paediatric patients require dedicated specialty care, not simply for the procedure alone, but for the entire care experience; this often translates into more clinic visits and family meetings, tailored patient experiences for the children with dedicated paediatric or child-life specialty ancillary or support staff, paediatric trained sedation or anaesthesia practitioners, and availability of paediatric specific subspecialty services such as intensive care units, surgery, etc.

“In terms of the procedure itself, because the cases often require general anaesthesia, communication with patients during the procedure is not possible, and depending on the age, can be difficult or impossible before and after procedures. Small body sizes render much of our existing equipment disproportionate, clumsy, or even useless. Limitations on intravascular contrast and radiation exposure can restrict or severely limit which procedures can be performed.

“Finally, the disease processes in children are generally very different from those in adults. This compounds the issues already mentioned and makes many adult interventionalists very uncomfortable treating paediatric patients, even if the interventional techniques themselves are used routinely in adults. Formal training in paediatric interventional radiology, including sub-subspecialty fellowships, is becoming more recognised and available, but is currently still quite limited,” they stated.

Improvisation can make for better care

Interventional radiology is characterised by its inventiveness and paediatric interventional radiologists are sometimes forced to apply this to their daily work in order to optimise devices for their patients.

Sze and colleagues maintain that there is often improvisation needed in paediatric interventions, mainly in intravascular procedures. “Cutting wires and catheters to length (with additional modifications on the table) is often needed, particularly in infants. Transjugular liver biopsies can be performed in infants with improvised percutaneous biopsy tools. Occasionally, cases are delayed or not feasible because of the lack of appropriately sized devices, which can sometimes be specially ordered or custom constructed, such as stent-grafts, but the FDA and local Institutional Review Boards may discourage improvisation that is perceived as risky,” they explained.

Sometimes paediatric interventionalists use miniaturised devices for other indications in order to proceed with the procedure. “Renovascular hypertension is pretty rare in children but we have a relatively large cohort of patients in our centre. We commonly use 2.5–4mm coronary artery stents to treat their renal artery stenosis, as standard stents are too large for paediatric cases,” Barnacle illustrated.

Guevara draws attention to liver biopsy patients who are at a high risk of bleeding, or ascites that require that the biopsy be obtained via a transjugular approach. “All the kits that are being manufactured are made for adults. If the patient is an infant, then these kits are too large. However in order to minimise the risk of bleeding, we sometimes have to use these large transjugular liver biopsy kits in small patients and be very careful not to injure the veins or to obtain a liver biopsy sample that traverses the liver out of the capsule,” he noted.

Guidance

In May 2014, the US FDA released a guidance document stating that companies applying for premarket approval should also provide paediatric device use information. The document stated: “Section 515A requires submitters to FDA of premarket approval applications (PMAs), supplements to PMAs, humanitarian device exemptions), and product development protocols for new devices to include readily available information about paediatric subpopulations that suffer from a disease or condition that the device is intended to treat, diagnose, or cure.” The purpose of seeking this information, the US FDA said, was ultimately “to use these data to determine unmet paediatric needs in medical device development. Once unmet needs are identified, the FDA will be better able to coordinate efforts of stakeholders, device manufacturers and FDA staff to promote new device development and proper labelling of existing medical devices for paediatric use.”

“Medical technologies save lives, improve health and contribute to sustainable healthcare. Many of these products bring value to adults as well as children and newborns. In some cases, however, specific modified versions of the technology are developed to improve treatment outcomes or reduce adverse events. These range from diagnostic HIV-tests for foetuses over tracheostomy tubes for infants, to child-friendly blood-glucose meters. The medtech industry will continue to develop paediatric and child-friendly technologies in those scenarios where we can bring more value to patients in doing so,” noted MedTech Europe, an alliance of European medical technology industry associations European Diagnostic Manufacturers Association (EDMA) and Eucomed in a statement to Interventional News.

Sze and colleagues point out that the paediatric device market is very small. “Despite the fact that 25% of the US population is under 18 years of age, only about 5% of the overall healthcare expenses are applied to paediatric medical care. There is a developing consortium of interventionalists lobbying the governmental funding agencies and the device industry to invest in paediatric interventional tool development. Funding and profits are currently scant or nonexistent. We need to find a way to incentivise the development and manufacture of devices tailored for children. One possible strategy would be for the large children’s hospitals to collaborate around key needs for paediatric medical device development and research, so as to be able to reach the economies of scale needed to move the industry and the field forward.

“The FDA has been a significant barrier to new device development in general, and the small size of the paediatric market makes it nearly impossible to recoup the investments required to bring new devices to market in this space. However, this is beginning to change since the FDA has begun to address the concern of a lack of innovation in paediatrics by instituting a Pediatric Consortia Grant Program, whose goals are “to support the development of nonprofit consortia designed to stimulate projects which will promote paediatric device development.”  Additionally, the FDA has removed the profit prohibition for humanitarian device exemption (HDE) devices used to treat children, which may incentivise ventures into this space,” they noted.

Barnacle concurs. “We should be taking our lead from the pharmaceutical industry, where there are often incentives for companies to extend trials into paediatric age groups. The same incentives do not seem to exist for devices, so most devices are not tested or modified for use in children,” she said.

The International Carotid Stenting Study (ICSS) randomised trial has reported the long-term outcomes after stenting versus endarterectomy for treatment of symptomatic carotid stenosis in The Lancet, online ahead of print, on 14 October.

“Stenting is an alternative to endarterectomy for treatment of carotid artery stenosis, but long-term efficacy is uncertain,” the authors wrote in the background to the trial. Their findings conclude that long-term functional outcome and risk of fatal or disabling stroke are similar for stenting and endarterectomy for symptomatic carotid stenosis.

The study followed 1,713 patients with carotid artery disease, of whom 855 were assigned to stenting and 858 to endarterectomy, for up to 10 years. The median follow-up was 4.2 years. Both techniques were found to be equally good at preventing fatal and disabling strokes, but patients who underwent stenting were slightly more likely to have minor strokes without long-term effects. The risk of any stroke in five years was 15.2% in the stenting group compared to 9.4% in the endarterectomy group, but the additional strokes were minor and had no impact on long-term quality of life.

The paper was authored researchers from University College London (UCL), Basel University, Switzerland, the London School of Hygiene & Tropical Medicine, the University Medical Center Utrecht, Netherlands, Sheffield Teaching Hospitals NHS Foundation Trust, and Newcastle University.

“At the moment, stenting is not widely used in the UK due to historical uncertainty over its long-term effectiveness,” said study leader Martin Brown from the UCL Institute of Neurology. “However, we have now shown that stenting is just as good as endarterectomy for preventing fatal and disabling strokes. We have also shown that the risk of stroke during the procedure is no higher for stenting than for endarterectomy in younger patients. The risks of each procedure are different and will vary depending on the patient, but stenting should be offered as an option to many more patients under the age of 70.

“One of the issues is that there are not many centres in this country that currently offer stenting as an option so the patient choice is not there. Now that we know stenting is effective in the long-term, more staff should be trained to carry out the procedure and gain experience. Otherwise there is a vicious cycle where nobody at a centre has stenting experience so patients are only offered endarterectomy and staff cannot learn or observe the procedure. In other countries, stenting is more widespread and the safety of the procedure improves as staff gain experience.”

The authors wrote in The Lancet: “Overall we found that stenting and endarterectomy are durable procedures that are equally effective in preventing severe strokes that lead to disability or death. Stenting has the disadvantage of causing more minor non-disabling strokes in the procedural period and possibly in the long term. This feature, however, must be weighed against the increased risk of procedural myocardial infarction, cranial nerve palsy, and access-site haematoma associated with endarterectomy. The modified Rankin scale scores suggested similar short-term and long-term functional outcomes with the two treatments. The choice between stenting and endarterectomy should take into account the different procedure-related risks in line with other characteristics of individual patients.”

Shamim Quadir, research communications manager at the Stroke Association said: “These latest research findings suggest that overall, stenting is just as safe, and equally effective for the long-term prevention of fatal and disabling strokes. Both procedures carry their own risks, and these will need to be considered for each individual patient. This research provides a vital step in providing another viable option which will help people significantly reduce their stroke risk.”

Suresh Vedantham, professor of Radiology, Interventional Radiology Section, Washington University School of Medicine in St Louis, USA, spoke to Interventional News on the latest from the paper “Quality improvement guidelines for the treatment of lower-extremity deep vein thrombosis with use of endovascular thrombus removal” hot on the heels of its online publication in the Journal of Vascular and Interventional Radiology (JVIR).

What prompted the need for new guidelines?

The quality improvement guidelines for catheter-directed thrombolysis for deep vein thrombosis have been updated to reflect current practice, and have a substantially improved evidence foundation due to inclusion of information from new studies including two randomised trials. During the last decade, there have been major changes in the key pillars of clinical deep vein thrombosis practice. New oral anticoagulant classes have been introduced; the completed SOX trial (Compression stockings to prevent the post-thrombotic syndrome) has cast major doubt on the idea that compression stockings can prevent the post-thrombotic syndrome; and the practice of catheter-directed thrombolysis has evolved considerably to incorporate improved patient selection, technical refinements (including the frequent use of thrombectomy devices, stents, and retrievable caval filters), and longitudinal care by endovascular practitioners.

Why is this paper important currently?

A new study published in Journal of the American Medical Association (JAMA) (see page 21)observed a substantially higher risk of adverse safety outcomes in patients who received catheter-directed thrombolysis plus anticoagulation vs. anticoagulation alone in real-world US practice between 2005 and 2010. While this study’s non-randomised methodology and reliance on administrative coding data likely introduced substantial bias into the comparison, physicians who offer catheter-directed thrombolysis should work hard to meet the high standard of safety that is being demanded by the medical community. We must not take for granted the risks involved in routinely offering thrombolytic therapy to patients with deep vein thrombosis who, after all, are being treated not in a life-saving capacity (as with myocardial infarction or stroke) but to optimise limb function and quality of life.

What are the key updates in the revised guidelines?

Key changes include: a) safety thresholds that are a little more stringent, reflecting the improved safety observed in catheter-directed thrombolysis studies between 2006–2013 compared to before; b) a focus on ensuring longitudinal care to optimally assess the outcomes of therapy and to reduce unnecessary late risks such as those from long-term inferior vena cava filter implantation; and c) sections that succintly summarise measures to prevent bleeding and pulmonary embolism during and after catheter-directed thrombolysis.

How will this paper serve as a tool for local quality improvement programmes?

This article offers physicians a template around which to design internal deep vein thrombosis quality improvement programmes. The authors’ ambition is for practicing physicians to build strong longitudinal care systems around deep vein thrombosis care, to ensure that patients can be provided catheter-directed thrombolysis as safely and as effectively as possible.

This article represents the best consensus quality improvement tool we could develop within the bounds of existing catheter-directed thrombolysis studies, which are still quite limited in scope and methodology. We hope and expect that the next version of these guidelines will be created with the benefit of additional randomised trial data, including that from the National Institute for Health-sponsored, multicentre, randomised, assessor-blinded, ATTRACT (Acute venous thrombosis: thrombus removal with adjunctive catheter-directed thrombolysis) trial which has nearly completed patient accrual.

There is a compelling case for the medical community, including the device industry, to develop specific devices that are appropriate for paediatric patients. Paediatric interventional radiologists often have to “make do” and be creative in order to treat children whilst using devices that are designed for and tested on adults only. The need for appropriate devices for the paediatric population ranges from the common and simple, such as long-term feeding tubes and vascular access devices, to the expensive and biomechanically complex, such as bioabsorbable stent-grafts, say opinion leaders in the field.

There are many factors that make it difficult to tailor devices to paediatric patients (who range from neonates to teenagers) and who need devices that remain suitable and effective as the patients grow. Still, paediatric interventional radiologists see a real need for children-specific kits and are calling for incentives within the medical device industry to help drive testing and modifications for children, in order to improve patient care.

Alex Barnacle, consultant interventional radiologist, Department of Radiology, Great Ormond Street Hospital for Children, London, UK, told Interventional News: “There are almost no paediatric-specific interventional radiology devices available, other than intravenous access devices. There is a modified paediatric version of a transjugular liver biopsy set available, which is still too large for use in small children, and a paediatric transjugular intrahepatic portosystemic shunt (TIPS) set, but otherwise most devices are only available in adult sizes.”

Daniel Sze, professor, Interventional Radiology with his colleagues Matthew Lungren, assistant professor and F Glen Seidel, clinical professor from the Lucile Packard Children’s Hospital, Stanford University, Stanford, USA, said, “There are very few devices specifically tailored for children, and this is a glaring unmet need for paediatric interventional radiology. However, there has been significant movement in the interventional marketplace to optimise intravascular devices for smaller and smaller size vessels as the demand increases in the adult interventional marketplace (ie. below the knee and retrograde revascularisation procedures, radial artery access); in fact, some basic interventional tools are already maximally miniaturised (needles, wires, microcatheters). For the most part, however, adult devices continue to be the only available devices for use in children, leaving few, if any, paediatric specific device options. 

Carlos J Guevara, Instructor of Radiology, Washington University School of Medicine, Mallinckrodt Institute of Radiology, St. Louis, USA, echoes their views. “Most devices are made for adult patients and therefore in many circumstances we have to get creative and use whatever tools we have available to us. I do not think there are enough adequate interventional radiology devices for use in paediatric patients and that includes common devices such as central vein catheters as well as more advanced devices such as transjugular biopsy needles and thrombolysis catheters,” he said.

Most needed devices

While there are several different types of devices that need to be tailored to provide better care for paediatric patients, some of the most apparent ones include devices for central vein access, transvenous biopsy, enteral access, fluid drainage, and endovascular procedures. 

“One of the biggest challenges is finding suitable long-term feeding tubes for small children. The small calibre gastrojejunal tubes needed in young children are simply not available, and this means that small children have to either continue to have uncomfortable nasojejunal tubes for several years or we have to place large calibre 16Fr feeding devices, which are really unsuitable for children who are only a few kilograms in weight,” Barnacle pointed out.

In Guevara’s view, “Two of the most common procedures done in paediatric patients are central line placement for venous access and drain placement for abscesses. Most of the catheters are designed for adult patients and the lines or catheters have to be positioned and covered so that they are not at risk from being pulled out inadvertently by children. In some instances there is a lot of redundancy of the device outside of the body which makes it difficult for the patient, the family, and the healthcare workers who have to work with the catheters.”

Sze and colleagues also make the case for low dose (high quality) fluoroscopy. “Dose awareness has reached a peak in other modalities such as CT, but still lags somewhat in the interventional fluoroscopic suite. There are major advances on the horizon by the major manufacturers, who are close to achieving clinically advanced low-dose fluoroscopy and digital subtraction angiography without compromising image quality.

“For devices, one major area that the community hopes to see movement in is bioabsorbable medical device platforms, such as vascular stents. Other areas that need more attention include vascular access devices such as peripherally inserted central catheters (PICCs) and gastrostomy and gastrojejunal tubes. For vascular procedures, lower profile angiographic catheters of similar shapes and performance as adult models are needed,” they outlined.

Difficult patients

Paediatric interventionalists expound that there are both inherent and external challenges to paediatric devices—for example, the biology of growing bodies is a taxing environment for permanent implantable devices. In addition, available data in adult patients may not accurately predict outcomes in children. From a technical point of view, it is their small size that can be a challenge. “The bodies of paediatric patients can be quite small and it can be challenging to adapt to carrying out a procedure in children for this reason. For example, some veins in children can be just a few millimetres wide and it can be difficult to get access. Also, since most of the equipment and devices are made for adults, this can add to the complexity of making these work when you have a small patient. For instance, when you have equipment that is designed for use in large adults (such as enteral access kits to place gastrostomy and gastrojejunostomy tubes), it is quite challenging to then use this same equipment for children,” said Guevara.

Another aspect to be considered is the type of anaesthesia needed to carry out interventional radiology procedures in children. “Most interventional radiology procedures in adults are done using moderate sedation, and that is not possible for most paediatric patients. Anaesthesia collaboration is necessary, which adds another layer of complexity,” he continued.

Barnacle agreed: “Many children are frightened when they come into hospital and can be uncooperative because of fear or because of their limited level of understanding of what is happening to them. So paediatric units have to have far more capacity for sedation and general anaesthesia cases, and this is not always easy to achieve.

Sze and colleagues point out that “With very few exceptions, paediatric patients require dedicated specialty care, not simply for the procedure alone, but for the entire care experience; this often translates into more clinic visits and family meetings, tailored patient experiences for the children with dedicated paediatric or child-life specialty ancillary or support staff, paediatric trained sedation or anaesthesia practitioners, and availability of paediatric specific subspecialty services such as intensive care units, surgery, etc.

“In terms of the procedure itself, because the cases often require general anaesthesia, communication with patients during the procedure is not possible, and depending on the age, can be difficult or impossible before and after procedures. Small body sizes render much of our existing equipment disproportionate, clumsy, or even useless. Limitations on intravascular contrast and radiation exposure can restrict or severely limit which procedures can be performed.

“Finally, the disease processes in children are generally very different from those in adults. This compounds the issues already mentioned and makes many adult interventionalists very uncomfortable treating paediatric patients, even if the interventional techniques themselves are used routinely in adults. Formal training in paediatric interventional radiology, including sub-subspecialty fellowships, is becoming more recognised and available, but is currently still quite limited,” they stated.

Improvisation can make for better care

Interventional radiology is characterised by its inventiveness and paediatric interventional radiologists are sometimes forced to apply this to their daily work in order to optimise devices for their patients.

Sze and colleagues maintain that there is often improvisation needed in paediatric interventions, mainly in intravascular procedures. “Cutting wires and catheters to length (with additional modifications on the table) is often needed, particularly in infants. Transjugular liver biopsies can be performed in infants with improvised percutaneous biopsy tools. Occasionally, cases are delayed or not feasible because of the lack of appropriately sized devices, which can sometimes be specially ordered or custom constructed, such as stent-grafts, but the FDA and local Institutional Review Boards may discourage improvisation that is perceived as risky,” they explained.

Sometimes paediatric interventionalists use miniaturised devices for other indications in order to proceed with the procedure. “Renovascular hypertension is pretty rare in children but we have a relatively large cohort of patients in our centre. We commonly use 2.5–4mm coronary artery stents to treat their renal artery stenosis, as standard stents are too large for paediatric cases,” Barnacle illustrated.

Guevara draws attention to liver biopsy patients who are at a high risk of bleeding, or ascites that require that the biopsy be obtained via a transjugular approach. “All the kits that are being manufactured are made for adults. If the patient is an infant, then these kits are too large. However in order to minimise the risk of bleeding, we sometimes have to use these large transjugular liver biopsy kits in small patients and be very careful not to injure the veins or to obtain a liver biopsy sample that traverses the liver out of the capsule,” he noted.

Guidance

In May 2014, the US FDA released a guidance document stating that companies applying for premarket approval should also provide paediatric device use information. The document stated: “Section 515A requires submitters to FDA of premarket approval applications (PMAs), supplements to PMAs, humanitarian device exemptions), and product development protocols for new devices to include readily available information about paediatric subpopulations that suffer from a disease or condition that the device is intended to treat, diagnose, or cure.” The purpose of seeking this information, the US FDA said, was ultimately “to use these data to determine unmet paediatric needs in medical device development. Once unmet needs are identified, the FDA will be better able to coordinate efforts of stakeholders, device manufacturers and FDA staff to promote new device development and proper labelling of existing medical devices for paediatric use.”

“Medical technologies save lives, improve health and contribute to sustainable healthcare. Many of these products bring value to adults as well as children and newborns. In some cases, however, specific modified versions of the technology are developed to improve treatment outcomes or reduce adverse events. These range from diagnostic HIV-tests for foetuses over tracheostomy tubes for infants, to child-friendly blood-glucose meters. The medtech industry will continue to develop paediatric and child-friendly technologies in those scenarios where we can bring more value to patients in doing so,” noted MedTech Europe, an alliance of European medical technology industry associations European Diagnostic Manufacturers Association (EDMA) and Eucomed in a statement to Interventional News.

Sze and colleagues point out that the paediatric device market is very small. “Despite the fact that 25% of the US population is under 18 years of age, only about 5% of the overall healthcare expenses are applied to paediatric medical care. There is a developing consortium of interventionalists lobbying the governmental funding agencies and the device industry to invest in paediatric interventional tool development. Funding and profits are currently scant or nonexistent. We need to find a way to incentivise the development and manufacture of devices tailored for children. One possible strategy would be for the large children’s hospitals to collaborate around key needs for paediatric medical device development and research, so as to be able to reach the economies of scale needed to move the industry and the field forward.

“The FDA has been a significant barrier to new device development in general, and the small size of the paediatric market makes it nearly impossible to recoup the investments required to bring new devices to market in this space. However, this is beginning to change since the FDA has begun to address the concern of a lack of innovation in paediatrics by instituting a Pediatric Consortia Grant Program, whose goals are “to support the development of nonprofit consortia designed to stimulate projects which will promote paediatric device development.”  Additionally, the FDA has removed the profit prohibition for humanitarian device exemption (HDE) devices used to treat children, which may incentivise ventures into this space,” they noted.

Barnacle concurs. “We should be taking our lead from the pharmaceutical industry, where there are often incentives for companies to extend trials into paediatric age groups. The same incentives do not seem to exist for devices, so most devices are not tested or modified for use in children,” she said.

The 12-month results of the study, presented at CIRSE 2014, demonstrated that new microwave technology can achieve a substantial rate of complete necrosis of liver metastases, even in a short-term treatment with few major complications.

The study was based on the premise that the latest microwave technology is expected to obtain larger volumes and faster area of ablation than radiofrequency. Guido Poggi, Istituto Clinico Città di Pavia, Pavia, Italy, presented the results.

The researchers collected data from 14 Italian centres. They treated 312 tumours that were unresectable liver metastases from colorectal cancer in 178 patients. There were 116 patients who had a single lesion; 15 of these developed another single metachronous lesion. Forty patients presented with two lesions; 18 presented with three lesions, and 19 presented with more than three lesions. The mean diameter was 2.7cm. Of these, 30% were deep lesions and 70% were superficial, and 30% of the lesions were close to the vessels, Poggi, said.

The researchers observed a complete response in 268 lesions (86%). Complete response was obtained in 97.5% lesions

Poggi told Interventional News: “Taking into account the limitations of a retrospective, multicentre study, the results that we have observed are very encouraging, particularly with regard to the high rate of complete ablation obtained in lesions up to 4cm in diameter. These results confirm that the latest microwave technology is a promising technique for the treatment of patients with colorectal liver metastases.
We used a microwave 2.45MHz generator (Amica-Gen) delivering energy of 40–100W through a 14 or 16 gauge internally cooled coaxial antenna (Amica-probe), featuring a miniaturised quarter wave impedance transformer (“mini-choke”) for reflected wave confinement. An automatic peristaltic pump was used for applicator cooling to avoid the probe overheating.”