A new report that documents the demographics, treatment modes and outcomes of more than 84,000 patients from 386 hospitals, in ten countries who underwent treatment for abdominal aortic aneurysms (AAAs) or carotid reconstruction, will be released at this year’s European Society for Vascular Surgery (ESVS) meeting in Nice, France.

• Features

At the ESVS meeting in September 2008, Professor Andrew Bradbury, Birmingham, UK, presented an update on the UK-based, HTA-funded Bypass versus Angioplasty in Severe Limb Ischaemia of the Leg (BASIL) trial.

The BASIL trial was designed to investigate whether, in patients with severe limb ischaemia (rest pain, tissue loss) due to infra-inguinal disease, bypass surgery or balloon angioplasty are associated with a better outcome in terms of amputation-free survival, all cause mortality, a range of secondary clinical endpoints, health-related quality of life and hospital costs.

Since the interim results were published in the Lancet in 2005 patients have been followed for a further 2.5 years; 54% of patients have now completed more than five years follow-up. Although the latest analysis has shown no significant difference in amputation-free survival between the two groups, Bradbury explained that "in patients who survive two years after intervention, surgery was associated with a significant 7.3 month improvement in subsequent all cause mortality at an additional non-significant hospital cost of circa £3,500 over the first three years."

Commenting on the results, Bradbury asked ‘Why might surgery be better in the longer term?’ One explanation, he said, is that revascularisation with surgery appears to be more complete and durable than with angioplasty. In addition, patients who had surgery were less likely to require further intervention, so avoiding the dangers of being back in hospital. A third reason may be aftercare. "Most of the patients who underwent bypass surgery were put under some kind of graft surveillance programme, and also there is a suggestion that these patients have better medical aftercare," Bradbury said.

In conclusion, the BASIL trial strongly suggests that angioplasty should be considered first line treatment for high-risk patients (specifically those with a predicted survival of less than two years) and for patients with no usable veins (the BASIL trial data relates largely to vein [75%] rather than prosthetic grafts). This is because, in the short term (up to one or two years), angioplasty is less morbid and less expensive and such patients will not live to enjoy the longer-term benefits of surgery. However, for all other patients (about 75% of the BASIL cohort) Bradbury recommends surgery as first line treatment. "What we really need is a predictive tool to try to determine which patients will live to two years," he said, adding that such a tool is currently being developed from the BASIL trial cohort to aid future decision-making.

By Florian Dick

The current prognosis of critical limb ischaemia is still very poor and amputation rates continue to increase across Europe despite the fact that arterial reconstruction and, in particular, endovascular options for below-the-knee recanalisation have evolved at an incredible pace in recent years.

• Features

Drug-eluting balloons were a much-discussed topic at this year’s TCT conference, in October 2008, Washington DC. Two sets of results showed that the area is making headway, and the usefulness of this type of device.

• Features

A new report that documents the demographics, treatment modes and outcomes of more than 84,000 patients from 386 hospitals, in ten countries who underwent treatment for abdominal aortic aneurysms (AAAs) or carotid reconstruction, will be released at this year’s European Society for Vascular Surgery (ESVS) meeting in Nice, France.

• Features

By Roger Greenhalgh

An inaugural meeting of the ilegx initiative was launched at Imperial College at the weekend of 25–26 October 2008. The initiative took place under the organisation of BIBA Conferences, which runs the Charing Cross Symposium series. However, it was very much the creation of three interdisciplinary programme directors, Dr Michael Edmonds, diabetologist, Kings College Hospital, London; Professor Gunnar Tepe, interventional radiologist, Tuebingen, Germany; and Dr Dieter Mayer, vascular surgeon and wound care expert, Zurich, Switzerland. The initiative was led in BIBA by Antje Kiewell, who has a background of “blue chip” marketing at Procter & Gamble. Those skills have been tested to the maximum on this initiative.

From the medical point of view, I became supportive of this concept when, to my horror, I realised one day that I had led a Regional Vascular Service in West London for some 25 years and the amputation rate is rising alarmingly. It is really upsetting to have to accept that the population is less well served now than when I was trained. And I thought I was saving legs all the time! I went to sleep at night pleased to have served my patients and with various reconstructions, kept their legs on. Were the vascular surgeons not crowing that even if we do not prolong life, our patients die “with their boots on.” It seems not. I was shocked and needed to investigate why and if this really is the case.
Antje organised by teleconference with the busy programme directors a programme to throw light on this matter. It soon emerged that the initiative would be pan-European to see if the problem is widespread and to see if the cures for the problem in each country are similar or contrasting. There was to be a diagnostic day on the first day and a management day after that .It was agreed that the programme directors would act as chairmen and also summarise the findings at the end of each day.
The speakers were carefully briefed and stuck to the systematic approach. In particular the audience appreciated that the speakers went logically through the sequence of causes of leg and foot ulceration .The diagnostic “wheel” was frequently quoted and acted as a spur to logical coverage of diagnosis in this sequence.

100 legs lost per week in the UK

Michael Edmonds addressed almost 300 delegates from 24 different countries and from many disciplines including vascular surgeons, diabetologists, endocrinologists, dermatologists, neurologists, podiatrists, orthopaedic and plastic surgeons, and wound care experts, as well as vascular scientists and nurses. He opened the ilegx Consensus Summit Meeting with these words: “In the UK, 100 legs per week are lost in diabetic patients,” quoting Dr Douglas Smallwood, Chief Executive of Diabetes UK. “Conservative estimates are that 50% of these are preventable. This is not acceptable.” It soon emerged that the rise in major amputations is by an increase in diabetic patients. Such patients have an increased chance of having arterial insufficiency and once an ulcer occurs, it can extend to amputation very fast indeed. The sugar laden tissues are a good culture medium for infection and it is vital to make the diagnosis rapidly. The faculty explained that diagnosis is achieved in the age-old way of history, physical examination and special investigations. There is a majority chance that an ulcerated foot has a vascular, arterial, venous or lymphatic cause. Vasculitis was discussed, and the need to involve a dermatologist for this diagnosis emerged and with it the need for biopsy.

Urgent referral needed

The second day began with prevention and I had a serious shock as a member of the audience. It simply appears too much to expect that a diabetic patient should be diagnosed earlier and the course of the disease altered. I had thought this would be the way. No. It seems the best we hope for is for early referral once an ulcer has occurred. This was big news for me and raised the issue of why these patients are not referred sooner, if this is focally important!
Apparently about two ulcerated feet per year are likely to be seen by a general practitioner and the family doctor does not pay enough attention to something that occupies so little of his time. What is needed is urgent referral. There is apathy and this is not confined to one country but is widespread. On top of this, the prevalence of diabetes is increasing along with rising obesity in many Western countries.
There is even talk of rewarding the doctor who does not refer to secondary care! In Switzerland we heard that there is endless resource available for amputation but no reimbursement for preventative podiatry and sensible footwear. That is not all of the problem. There is an inbuilt obstruction to cross referral as this costs money and so interdisciplinary working is not encouraged. It is surmised that the rising amputation rate is because of such issues, late referral of diabetic ulceration of the foot and lack of referral to an open access interdisciplinary approach. Dr Edmonds champions this approach but I question if it is as easy now to set this up as it was when he started it. The National Health Service (NHS) has changed in the UK. At about the same time as Michael Edmonds was setting up his diabetic open access clinic, Charles McCollum, then at Charing Cross with Christine Moffatt, set up the Riverside Venous Ulcer Service. This had a similar open access approach and encouraged nurses to refer to nurses from the community to the specialist centre, in this instance, the Regional Vascular Service at Charing Cross.
So, at the inaugural ilegx meeting, we learned that ulcers should be referred early and we learned that upon patient arrival in hospital, it is imperative that the circulation should be assessed and that it should be ascertained if the patient is diabetic and especially if there is infection in the foot or leg and if the blood supply is adequate. The action step is to control infection that moment not to delay it. Debridement should be adequate and this can imply minor amputation such as ray amputation. Above all, the infection must be controlled at once and the wound cleaned and washed regularly. Antibiotics also play a role. If blood flow is compromised it should be corrected, as debridement is done not in stages. It would be helpful if there were data to show that early referral is beneficial and it would be likewise good for proof that interdisciplinary working does benefit the patient. Much is anecdotal but we must start somewhere.

The interdisciplinary wheel

The audience appreciated that Antje Kiewell had summarised the disciplines that could be involved in various pathologies based upon what the programme directors had fed to her before the meeting. This was in the form of a moving wheel, which was appreciated. This enabled the group at least to have a system to add to and update. It is a type of algorithm that enables the specialist to be reminded of which disciplines might have an interest given a particular diagnosis.
This was just a start. At least it has been discussed and I feel better that there are others who now share my disappointment over the rising amputation rate. It is Europe wide. It is mainly from late treated diabetes. We should be able to save 50% more legs than we do. It would not just be better for the patient. It would be cheaper. Is that the key? I hope not! We should stop this trend for people and mankind not for bankers. These poor souls are not part of the “credit crunch.” They could be yours and my loved ones.
I will end with an example that is vivid in my memory. My son, Stephen, called his grandfather, the father of my wife, Karin, “Biba.” This “Biba” had a stroke and lost sensation in the paralysed leg. I am not sure he had diabetes at the end but he definitely had to take too much dead weight pressure on his heel. I saw him in his Alpine village hospital bed whilst I was on holiday and reminded the nurses to keep pressure off the heel and cushion the foot. Debridement was delayed and he came to major amputation and died soon after. That was correctable. It should not have happened. Stephen called his company after “Biba.” There are thousands of instances of “Bibas” and we need to stop it. An ulcer on the foot can lead to amputation. ilegx says that interdisciplinary skills should be deployed and this should save 50% of the amputations at least.

At the ESVS meeting in September 2008, Professor Andrew Bradbury, Birmingham, UK, presented an update on the UK-based, HTA-funded Bypass versus Angioplasty in Severe Limb Ischaemia of the Leg (BASIL) trial.

The BASIL trial was designed to investigate whether, in patients with severe limb ischaemia (rest pain, tissue loss) due to infra-inguinal disease, bypass surgery or balloon angioplasty are associated with a better outcome in terms of amputation-free survival, all cause mortality, a range of secondary clinical endpoints, health-related quality of life and hospital costs.

Since the interim results were published in the Lancet in 2005 patients have been followed for a further 2.5 years; 54% of patients have now completed more than five years follow-up. Although the latest analysis has shown no significant difference in amputation-free survival between the two groups, Bradbury explained that "in patients who survive two years after intervention, surgery was associated with a significant 7.3 month improvement in subsequent all cause mortality at an additional non-significant hospital cost of circa £3,500 over the first three years."

Commenting on the results, Bradbury asked ‘Why might surgery be better in the longer term?’ One explanation, he said, is that revascularisation with surgery appears to be more complete and durable than with angioplasty. In addition, patients who had surgery were less likely to require further intervention, so avoiding the dangers of being back in hospital. A third reason may be aftercare. "Most of the patients who underwent bypass surgery were put under some kind of graft surveillance programme, and also there is a suggestion that these patients have better medical aftercare," Bradbury said.

In conclusion, the BASIL trial strongly suggests that angioplasty should be considered first line treatment for high-risk patients (specifically those with a predicted survival of less than two years) and for patients with no usable veins (the BASIL trial data relates largely to vein [75%] rather than prosthetic grafts). This is because, in the short term (up to one or two years), angioplasty is less morbid and less expensive and such patients will not live to enjoy the longer-term benefits of surgery. However, for all other patients (about 75% of the BASIL cohort) Bradbury recommends surgery as first line treatment. "What we really need is a predictive tool to try to determine which patients will live to two years," he said, adding that such a tool is currently being developed from the BASIL trial cohort to aid future decision-making.

By Florian Dick

The current prognosis of critical limb ischaemia is still very poor and amputation rates continue to increase across Europe despite the fact that arterial reconstruction and, in particular, endovascular options for below-the-knee recanalisation have evolved at an incredible pace in recent years.

• Profiles

Professor Ziv J Haskal MD, Vice Chair and Chief of Vascular and Interventional Radiology at the University of Maryland, Baltimore, US

This early data from this study appear to bolster the already substantial controlled literature comparing TIPS to endoscopic therapy of oesophageal varices. There is undisputed Class I, Level A evidence that proves that TIPS, i.e. portosystemic shunt therapy, yields markedly lower esophageal variceal rebleeding rates compared to endoscopic band ligation or sclerotherapy. Notably, most prior trials, and meta-analyses, were comprised of patients whose shunts were created with bare metal stents. Treated populations varied amongst studies, from ones including Child C patients, to ones specifically excluding them in favour of healthier elective patients. Most, like this one, showed significantly higher crossover from endoscopic therapy to TIPS rescue.

It’s clear that modern TIPS means PTFE stent grafts. The patencies achieved, out-of-the-gate, vastly exceed those of bare stents. For this commentator, a decade of hundreds of bare stent TIPS revisions has essentially disappeared. It stands to reason that the reduced need for TIPS revisions (a need as high as 38% in some controlled trials) will correlate with lower recurrent symptoms, perhaps further magnifying the disparity between endoscopic therapies and TIPS. Several controlled trials comparing stent graft TIPS to medical therapies are underway. This is one such study.

The data in this study is still in early stages, and the details available to us in the abstract and presentation are necessarily thin. While the current conclusion seems eminently plausible, we must wait for more data. Some of the questions to be answered include: why is this a “high risk cirrhotic patient” population per the authors’ title? High risk for mortality – by virtue of their bleeding, amount of transfusion, liver function, metabolic derangement, intubation status, aspiration pneumonia, etc? Indeed, their exclusion of Child-Pugh score patients >13 generally defines the population as ‘healthier’ cirrhotics, but for their bleeding episode. If there is a mixture of oesophageal and gastric varices, then the cohorts will need to be separated, as therapies and endpoints vary in both medical and TIPS groups. Better characterisation of the acuity and metabolic abnormalities that define high risk, i.e. early mortality will be needed, perhaps using APACHE scores and, secondarily, MELD – this is appears to be one of this study’s niches. Indeed, one point that distinguishes most prior randomised trials was time to randomisation. As delays lengthen, from one day to one week, the selection bias toward ‘healthier’ surviving patients grows. Further, details describing graded rates of encephalopathy, the natural downside of TIPS, will be needed. All this data should undoubtedly follow, in the ultimate manuscript.

Finally, we can consider the basic premise: that a PTFE stent graft might provide better outcome than a bare stent when compared to endoscopic therapy. In reality, I would expect the early results of these stents to be relatively similar. In truly acutely bleeding patients, survival is first judged at 30 day intervals, not at one year. The relative upshot of a PTFE stent graft over a bare stent, in this acute window, is likely real, but small. The stent graft, if properly employed, would prevent the acute thromboses attributed to biliary-TIPS fistulae. But again, I’d expect this early effect is small.

After the Vienna ABSOLUTE trial RESILIENT is the only randomised controlled trial to report long-term results comparing primary stenting of the superficial femoral artery (SFA) and angioplasty.

As the optimal endovascular approach to SFA occlusive disease has been discussed very controversially for many years, these results are an important step towards establishing a missing basis of evidence and were received accordingly with great enthusiasm at two recent international vascular meetings: the British Society of Inventional Radiologists (BSIR) in Manchester in November 2008, and the VEITH meeting in New York a couple of weeks later. As in ABSOLUTE, primary femoropopliteal stenting was also in RESILIENT superior to angioplasty for symptomatic SFA occlusive disease and advantages were sustained at two years.

RESILIENT is an ongoing transatlantic multicentre trial that is conducted at 24 sites throughout the United States and Europe and involved 206 patients with life-style limiting claudication due to femoropopliteal lesions with a maximum length of 15 cm (mean lesion length 66 mm). The patients were randomised in a 1:2 ratio to either angioplasty alone (n=72) or angioplasty plus primary stenting (n=137) using C.R. Bards’ selfexpanding nitinol LifeStent (R). Primary endpoint was the clinically driven need for repeated revascularisations and secondary endpoints were initial procedural success, long-term vessel patency as assessed by duplex and sustained clinical improvement.

Dr. Barry Katzen, Founder of the Baptist Cardiac and Vascular Institute in Miami, Florida, and primary investigator of RESILIENT gave a detailed and comparative subgroup analysis of the European and US experience at BSIR in Manchester and an provisional interim analysis at 24 month follow-up at VEITH, both of which had not been published yet. “All patients have reached their 24 month follow-up by now”, Katzen said in New York, “however, some analyses are still being performed and are not available yet”. Essentially, the 12 month results showed a primary patency and freedom from repeated revascularisation in 80% and 87% of patients after primary stenting, respectively, whereas corresponding rates after angioplasty alone were 38% and 46% (P

Two-year results in favour of primary SFA stenting

“Ultrasound data were not recorded beyond 12 months”, Katzen explained long-term follow-up,”however, the Kaplan-Meier analysis of clinically driven revascularisations demonstrates an impressive advantage of primary stenting:  at 24 months only 20% of stented patients had needed a repeated revascularisation, whereas it was 62% after angioplasty alone.” The rate of major adverse clinical events was similar in both arms at two years (20%) and showed, as at 12 months, a similar safety of primary stenting as compared to angioplasty alone. The overall stent-fracture rate at 18 months remained low at 3.8% (3.1% at 12 months) and fractures occurred almost exclusively in the middle segment of the SFA and often when 2 or more stents had been used.

These results were very impressive and illustrated the enormous progress in recent stent technology as compared to earlier generations of balloon-expandable stainless steel stents. “It is important to remember that RESILIENT compared primary stenting to angioplasty alone and not to the common clinical strategy of angioplasty with optional stenting in cases of dissatisfactory morphological results”, Katzen pointed out. Hence bail-out stenting after angioplasty was analysed as failure of angioplasty according to the intention to treat and, indeed, bail-out stenting was needed in about 40% of patients in the angioplasty arm. However, primary stenting has been tested before against a clinical strategy of angioplasty with optional stenting in the Vienna ABSOLUTE and ASTRON trials, respectively, and even in these trials, patients benefitted from primary stenting. “Although use of drug-eluting balloons is promising to improve the long-term durability of angioplasty in the SFA, their use is unlikely to change the need for initial bail-out stenting drastically. However, they may justify a policy of angioplasty with selective SFA stenting in the future, but randomised trials have to show that first”, Katzen expanded on the clear demonstration of limitations of stand-alone angioplasty of the SFA in RESILIENT. As bailout stenting was significantly more often necessary for longer or more calcified lesions, the results of RESILIENT are in line with results of the other randomised trials on the subject (FAST and the Vienna trials) indicating that primary stenting is the superior strategy for long and complex SFA lesions. “We may not have solved the ‘SFA conundrum’ yet, but the emerging evidence points into a clear direction”, Katzen concluded.

Results at European and US sites similar

An interesting subanalysis was given at BSIR comparing the European experience at Leipzig, Germany, and Vienna, Austria (n=55) with their US counterparts. The demographic and disease specific characteristics of the patients were comparable across the atlantic. While bail-out stenting was less often needed at the European sites (20% vs 40% overall) and, thus, the results in the angioplasty arm were somewhat better, the advantages of primary stenting were still of similar magnitude in the European experience as in the US at 12 months follow-up (Figure).

Thus the long-standing controversy over the right endovascular approach to SFA occlusive disease is shifting currently from anecdotal to high-level evidence. Importantly, the available evidence is fairly consistent across the trials so far, and emerging long-term results confer a comfortable degree of certainty. Finally, meaningful debate becomes possible and indeed one of the ‘great debates’ at the upcoming 31^st Charing X meeting next April in London is dedicated to this important topic: it is certainly promising to become one of the exciting and entertaining highlights of the symposium.

At the CIRSE meeting 2008, held in Copenhagen, Denmark, Professors Johannes Lammer, Anthony Watkinson, and Riccardo Lencioni presented new data supporting the use of Biocompatibles’ PRECISION TACE with DC Bead (DC Bead loaded with doxorubicin) for the treatment of hepatocellular carcinoma (HCC). The multi-centre study compared drug-eluting beads (DEB) with conventional transarterial chemoembolization (cTACE).

Trial overview

Professor Johannes Lammer, Medical University of Vienna, Austria, presented an overview of the PRECISION V trial, first discussing the epidemiology of HCC. He stated that the disease is globally the fifth most common cancer, and over 600,000 new cases are diagnosed worldwide each year. HCC particularly affects the Eastern Asian population (370,000 cases each year), followed by Japan, Europe and the US populations, with 40,000, 32,000 and 19,000 new cases identified each year, respectively. Lammer added that HCC is the third leading cause of cancer-related mortality, and is the leading cause of death in cirrhotic patients.

The BCLC (Barcelona-Clinic Liver Cancer) Staging and Treatment Schedule for HCC categorises three main stages for treating the disease, explained Lammer. Stage 0 (early stage) normally results in resection, although, liver transplantation or PEI/RF (Percutaneous ethanol injection/radiofrequency) may be indicated. Stage A-C (intermediate stage) typically results in chemoembolization, PEI/RF or the administration of new agents, such as sorafenib. For terminal stage cancer, Stage D, symptomatic treatment only is administered (Figure 1).

The aim of the PRECISION V randomised phase II study was to investigate the safety and efficacy of chemoembolisation with DC Bead loaded with doxorubicin (PRECISION TACE with DC Bead) in an international, multi-centre trial. Roughly 200 patients were recruited in 23 European centres, with 100 patients randomised to each arm. Patients assigned to the control arm of the study were administered cTACE using doxorubicin mixed with lipiodol followed by a bland embolic. Patients received up to three treatments occurring at baseline, two and four months, and follow-up was for six months.

The primary endpoint was six-month tumour response rate measured by magnetic resonance imaging (MRI) and response criteria according to the EASL (European Association for the Study of the Liver). Secondary endpoints were safety (toxicity according to the South West Oncology Group and focussing on doxorubicin related events), time to progression, tumour response according to RECIST (Response Evaluation Criteria In Solid Tumors), local tumour response (EASL), time to discharge, cardiotoxicity, quality of life (QoL) and healthcare resource use.

Inclusion and exclusion criteria

According to Lammer, patients included in the study had HCC not suitable for curative treatments, multinodular HCC without vascular invasion or extrahepatic spread, recurrence following resection or percutaneous ablation, preserved liver function (Child Pugh A and B), or were on the transplant list but may not receive a transplant within six months.

Excluded patients were those with another primary tumour, previously treated with chemo- or radiotherapy, advanced liver disease, advanced tumoural disease, any contraindication for doxorubicin administration, and any contraindication for hepatic embolization procedures.

Lammer reported that after three treatments, technical success for the DC Bead group was 97% compared with 99% in the cTACE group (Figure 2). In terms of dose, the mean dose of doxorubicin for treatment 1 was 142.1mg vs. 102.9mg for the DC Bead and cTACE groups, respectively. For the second treatment, the dose was 115.3mg vs. 91.6mg, respectively, and for the third treatment it was 95.8mg vs. 85.4mg, respectively.

Efficacy outcomes – the primary endpoint

Professor Lammer, who was the principal investigator for the study, also presented tumour response data, which demonstrated greater tumour response in patients treated with PRECISION TACE with DC Bead.

DC Bead demonstrated an advantage in complete response (27 vs. 22%), objective response (52 vs. 44%) and disease control (63 vs. 52%). Furthermore, Professor Lammer showed that in patients with more advanced disease (those with Child Pugh B, ECOG 1, Bilobar or Recurrent Disease) DC Bead was significantly more effective (p<.05).

Safety outcomes

Professor Anthony Watkinson, the Royal Devon and Exeter Hospital, Peninsular Medical School, Exeter, UK, presented the safety outcomes of the PRECISION V trial, which was measured by the rate of adverse events and serious adverse events (SAEs), treatment-related events, and doxorubicin-related events.

He reported that the total number of adverse events was higher in the cTACE group (497) compared with the DC Bead group (423). SAE rates were equal for both groups (22) and related SAEs were slightly more common in the cTACE group (7) compared with the DC Bead group (6). In the majority of cases, it was observed that the number of SAEs by organ system was higher in the cTACE group than DC Bead (Figure 3).

In patients with more advanced disease, such as Child Pugh B, ECOG 1, bilobar disease, and recurrent disease, SAEs were more common in the cTACE group within 30 days of treatment, explained Watkinson. Death due to disease progression was also higher in the cTACE group than the DC Bead group (3 vs. 1, respectively), however, the total number of deaths due to all causes were equal (8).

In terms of doxorubicin-related side effects, such as alopecia, mucositis, marrow suppression and skin discolouration, the occurrence of each was very significantly higher in the cTACE group (Figure 4).

Patient impact

In discussing the safety outcomes and patient impact, Watkinson said the trial showed that patients treated with PRECISION TACE with DC Bead experienced fewer treatment-related SAEs, Grade 3 and 4 adverse events, and adverse events overall. Compared with the DC Bead group, 100 patients treated with cTACE experienced an additional two more related SAEs, eight more related Grade 3 and 4 adverse events, 24 more doxorubicin-related events, and 46 more adverse events related to the treatment.

He concluded by stating that PRECISION TACE with DC Bead is safe, shows equivalent overall numbers of events when compared to cTACE, but there is a significant (p=.0001) benefit from the DC Bead in reducing the effects of systemic doxorubicin. He also added that there is a near complete absence of alopecia and a marked reduction in serious liver toxicity in DC Bead patients, and the safety of the DC Bead therapy is maintained in advanced patients.

PRECISION V – Summary of results

To summarise the data and interpret the results, Professor Riccardo Lencioni, Pisa University Hospital of Medicine, Pisa, Italy, reported that overall, DC Bead has a greater rate of objective response (p=.11) and lower treatment-related adverse events and SAEs. Furthermore, DC Bead has a significant (p<.05) advantage in objective response in more advanced patients (p=.038) and disease control in more advanced patients (p=.026). Lencioni added that DC Bead demonstrates a highly significant (p<.01) advantage in the reduction of doxorubicin-related side effects (p=.0001) in all patients.

PRECISION TACE with DC Bead is “safe, efficacious and reproducible”, he said. Adding, “There is a significant advantage of using DC Bead in patients with more advanced disease – those with more compromised liver function, poorer performance status, bilobar tumour and recurrent tumour – greater response, greater disease control and improved safety.”. He observed that DC Bead offered a rare example of a new cancer treatment with greater efficacy and also reduced toxicity.

Currently, the AASLD (American Association for the Study of Liver Diseases) guidelines do not recommend chemoembolization for Child B and ECOG 1 patients, but given the results from the PRECISION V trial, the data shows that these patients can now be safely treated with PRECISION TACE with DC Bead, Lencioni concluded.

Professor Johannes Lammer, distinguished Interventional Radiologist at the University Hospital in Vienna, Austria, was awarded the honorary membership of the British Society of Interventional Radiology (BSIR) at its yearly meeting in November 2008 in Manchester, UK. Thereby, he carries forward the illustrous list of recent laureates including Professor Sven Seldinger, Professor Roger Greenhalgh and Professor Jim Reekers. In his keynote lecture after receiving the award he followed the tradition and addressed a fascinating application of interventional radiology in current vascular therapy: the endovascular management of aortic rupturs.

Endovascular repair of traumatic rupture of descending thoracic aorta established
Lammer structured his lecture into two parts and reminded the audience of the fundamental differences between ruptures of the descending thoracic aorta and the abdominal aorta. “Most ruptures of the descending aorta are of traumatic nature,” Lammer explained. “Hence, these patients are often relatively young and have sustained multiple trauma in addition to their thoracic injury.” Together with the complexity of open surgery in this anatomical region, the endovascular approach seems to confer crucial advantages conceptually. Lammer showed some of his own fascinating cases of successful thoracic endovascular aortic repair of traumatic ruptures and reviewed the current literature critically.

“The advantages of the endovascular approach seem already so clear-cut and extensive based on current data that randomised comparison are ethically difficult to envisage,” he explained. The series he cited had observed between 64 and 128 patients with traumatic and acute thoracic aortic ruptures and reported 30 day mortality rates relatively consistently around 7% (0–30%) for endovascular repair, whereas they ranged around 24% (20–55%) after open repair. Rates for major complications displayed similar differences (0–5% after endovacular repair and 3–16% after open repair). This documented an impressive reduction of early mortality from 24% to 7% by endovascular techniques. “However, we are still facing some distinct endovascular challenges in the descending aorta and the aortic arch, which need to be solved to ensure long-term durability,” Lammer warned, and alluded to the importance of graft compliance for sufficient seal in the aortic arch and the preservation of the supraaortic branches during the intervention. “Newer devices will have to address these problems satisfactorily by enhanced conformability and sidebranches that can be deployed precisely,” he added.

Abdominal aortic rupture: assessment of anatomical suitability is key

In the second part of his lecture, Lammer turned to the treatment of ruptures of the abdominal aorta. “These of course are almost exclusively due to ruptures of aortic aneurysms and our first concern should be their prevention by appropriate screening,” he explained citing the results of the UK MASS study (multi-centre aneurysm screening study) which showed a significant reduction of aneurysm (i.e. rupture) related deaths after screening. In the event, however, the most important decision to make currently is probably whether the patient’s anatomy is suitable for endovascular repair. “Commonly, surgeons have concerns regarding the delay dedicated imaging might cause. But there is fairly robust evidence that taking time for careful assessment does not endanger the patient,” he said. Among the studies he cited an Canadian report had shown no differences of overall mortality if patients were transferred to another hospital which increased their time-to-operation from three to six hours. “In addition, natural history studies have shown that 90% of patients survive the first two hours after hospital admission and that the median time-to-death is almost 11 hours after admission,” Lammer explained. Therefore, the time needed for a CT scan seems unlikely to affect the prognosis of the patient. Thus, Lammer proposed an algorithm based on these findings that included initial hypotensive resuscitation of the patient at a mean blood pressure of 70mmHg followed by a contrast CT. “Based upon the anatomical assessment tailored treatment in a dedicated Hybrid operating theatre becomes possible and is likely to confer most benefit to the patient,” Lammer said.

It is important to note, however, that only around 50% of patients can be estimated to be anatomically suitable for endovascular repair. “Maybe it is a subset of patients with unsuitable endovascular anatomy that is more prone to rupture,” Lammer speculated on these findings from the Amsterdam Acute Aneurysm Trial. “If endovascular repair is feasible, however, metaanalyses have shown quite consistently low operative mortality rates even below 20% and acceptable morbidity rates at 44%,” Lammer said, illustrating potential advantages of endovascular repair over open repair where respective figures still range around 35–40% (operative mortality) and 55% (morbidity), respectively. “Thus, the ability to offer both endovascular and open repair seems to improve patients’ survival significantly with a 3.8% increase in survival for each 10% increase in EVAR application,” Lammer summarised and cited a systematic review of 1200 patients. Thus, the important take home messages of this state of the art lecture were that a CT scan did probably not increase patients’ mortality and was even unlikely to delay therapy significantly, that 45–67% of patients could currently be expected to be suitable for endovascular repair, and that each 10% increase in use of endovascular repair had the potential to lessen mortality of the whole patient population by 3.5%. Imminent developments in endovascular technology and imaging possibilties are likely to even excel these impressive improvements of interdisciplinary management of ruptured abdominal aortic aneurysm in the near future.

Drs John Arnold and Anne Roberts, comment about the use of the term, no longer included in the American Society of Anesthesiologists standards.

By Drs John Arnold, staff anaesthesiologist at Sharp Mary Birch Hospital for Women, San Diego, CA, and Anne Roberts, Chief of Interventional Radiology and Executive Vice Chair of the Department of Radiology, UCSD Medical Center, San Diego, CA

The term ‘conscious sedation’, despite its common use in anaesthesia and non-anaesthesia literature, is no longer included in the American Society of Anesthesiologists (ASA) standards. Its use is discouraged because it is imprecise, potentially misleading, and somewhat of an oxymoron. Because sedation and anaesthesia are recognised by the ASA as points on a continuum, a more appropriate term is “moderate sedation”. What follows is the ASA’s description of the four points on the continuum:

Minimal sedation (anxiolysis) – A drug induced state during which a patient responds normally to verbal commands. Although cognitive function and coordination may be impaired, ventilatory and cardiovascular functions are unaffected.
Moderate sedation/analgesia (‘conscious sedation’) – A drug-induced depression of consciousness during which patients respond purposefully to verbal commands, either alone or accompanied by light tactile stimulation. No interventions are required to maintain a patent airway, and spontaneous ventilation is adequate.
Deep sedation/analgesia – A drug-induced depression of consciousness during which patients cannot be easily aroused, but respond purposefully following repeated or painful stimulation. The ability to independently maintain ventilatory function may be impaired. Patients may require assistance in maintaining a patent airway and spontaneous ventilation may be inadequate. Cardiovascular function is usually maintained.
Anaesthesia – Consists of general anesthesia and spinal or major regional anesthesia. It does not include local anaesthesia. General anaesthesia is a drug-induced loss of consciousness during which patients are not arousable, even by painful stimulation. The ability to independently maintain ventilatory function is often impaired. Patients often require assistance in maintaining a patent airway, and positive pressure ventilation may be required because of depressed spontaneous ventilation or drug-induced depression of neuromuscular function. Cardiovascular function may be impaired.

A 2006 review by R Robbertze et al of closed claims for anaesthesia procedures outside the operating room showed that, when adjusted for total number of procedures, the claims for deaths in non-operating room anaesthesia were more than two times those for operating room anaesthesia. They also showed that non-operating room anaesthesia claims had a higher severity of injury and more substandard care than operating room anaesthesia. The most common mechanism of injury was inadequate oxygenation/ventilation. With this background, it is important to emphasise that all patients receiving moderate sedation should have a standard of care similar to that of an operating room.

All programmes for moderate sedation should be monitored by and follow guidelines established by the hospital’s anaesthesia department. This should include a system to periodically evaluate job performance as well as current competencies and skills of those administering moderate sedation. Additional necessary qualifications are certification in Basic Life Support and/or Advanced Cardiac Life Support. In the US, specially trained registered nurses under the direction of the radiologist perform much of the moderate sedation in interventional radiology suites.

Appropriate patient examination

There should be a sufficient number of qualified personnel, in addition to the physician performing the study or therapy, to be present during a procedure using moderate sedation and to do the following:

1. Evaluate the individual receiving care prior to beginning sedation/anaesthesia, ie, complete a history and physical;
2. Perform the sedation/anaesthesia;
3. Perform the procedure (study/therapy);
4. Monitor the individual undergoing sedation/anaesthesia; and
5. Recover and discharge the individual either from the post-sedation or post-anaesthesia recovery area or from the organisation.

Pre-procedure evaluation of the patient includes a history and physical. Pertinent aspects of the patient’s history should include: (1) abnormalities of major organ systems, (2) current medications, (3) drug allergies, (4) previous experience with sedation/analgesia as well as regional and general anaesthesia, (5) pregnancy, (6) history of tobacco, alcohol, or substance abuse, and (7) time and nature of last oral intake. An additional aspect of the patient’s health that should be considered, in view of the current epidemic of obesity, is the individual’s body mass index. 

Because most morbidity and mortality for patients receiving anaesthesia in a non-operating room setting is related to inadequate oxygenation and ventilation, often a result of airway obstruction, the patient’s history and physical should emphasise the airway. Patients at high risk include those with previous problems with anaesthesia; stridor, snoring, or sleep apnea; dysmorphic facial features (e.g. Pierre-Robin syndrome); and advanced rheumatoid arthritis.
 

Some physical exam issues of concern are those patients with significant obesity; short neck; limited neck extension; decreased hyoid-mental distance (<3cm); neck mass; small mouth opening (<3cm); protruding maxillary incisors; macroglossia; tonsillar hypertrophy; and non-visible uvula, among others. Many of these physical attributes may indicate that it would be difficult to secure the airway should the patient suffer an airway obstruction.

Pre-procedure laboratory testing should be individualised to the patient. For young, healthy patients, all that may be needed is a pregnancy test in women. In older patients, consideration should be given to obtaining a recent haematocrit, ECG, BUN, and/or blood glucose.

All patients receiving moderate sedation should follow the ASA Pre-Procedure Fasting Guidelines. For healthy adults without impaired gastric motility, this means a minimum of two hours of fasting following consumption of clear liquids and eight hours of fasting following consumption of a full meal including protein and fat. 

Sedation and analgesia

After the patient is evaluated and determined to be a candidate for moderate sedation and consent is obtained, the next step is to perform the sedation and analgesia. Monitors that may be used include electrocardiography, pulse oximetry, and a devise to measure blood pressure. Observational aspects of monitoring include level of consciousness and respiratory rate. Additional monitors to consider are an end-tidal CO2 monitor (helps in the assessment of ventilation) or a processed EEG monitor that aids in measuring the depth of anaesthesia. All vital signs should be recorded at specified intervals. Supplemental oxygen may be administered through a nasal cannula or mask as needed. Once a steady state is achieved, the individual who is performing the moderate sedation may assist the physician doing the procedure with short, interruptible tasks. If the patient slips into a state of deep sedation, the individual giving the sedatives and analgesics should give their undivided attention to the patient and attempt to bring them to a lighter level of sedation/analgesia.

The medications for moderate sedation are relatively few, but practitioners administering them need to be familiar with their pharmacologic profile. Medications should be administered in small, incremental doses through an intravenous line. The primary sedative used today is midazolam (Versed), though diazepam (Valium) is also a potential choice. The use of propofol, a powerful sedative hypnotic used most commonly for induction of general anaesthesia, is controversial in settings outside of the operating room or intensive care setting.  The narcotic used most frequently is fentanyl, although morphine, meperidine, or hydromorphone hydrochloride (Dilaudid)? may be better choices in situations requiring post-procedure analgesia. Though they should be rarely necessary, two reversal agents should be immediately available. The reversal agent for benzodiazepines such as midazolam is flumazenil and the reversal agent for narcotics is naloxone.

All settings where moderate sedation is administered should be adequately prepared for a respiratory or cardiac arrest. This includes not only the necessary equipment but also a mechanism for obtaining extra help to manage an arrest.

After the procedure, the patient should be transferred to an appropriate recovery area and monitored until they meet the discharge criteria established by the institution. They should be discharged from the hospital in the care of a responsible adult with instructions and a telephone number to call for emergencies.

The risks of sedation/analgesia may be increased by patient- and procedure- related factors. Uncooperative patients may require sedation to the point of general anaesthesia to remain still for a procedure for which others may need minimal or no sedation. There are extremely invasive procedures that even the most cooperative patient may be unable to tolerate with only sedation and analgesia. When the need for general anaesthesia is anticipated or becomes obvious during a procedure, it is prudent to enlist the assistance of an anaesthesiologist or nurse anaesthetist who is trained to care for patients who are deeply sedated or under general anaesthesia.

Due to staffing issues, it is rare that hospitals will have dedicated anaesthesiologists in the interventional radiology suite. If an anaesthesiologist is needed, the scheduled case will usually need to be arranged around the availability of that physician. Most anaesthesiologists prefer the productivity they can achieve in an operating room setting where cases are closely scheduled with minimal turnover times. If a similar arrangement could be accomplished in an interventional radiology suite, the attractiveness of giving anaesthesia in that setting would increase dramatically.

According to the 24-month results from the Xpert-BTK Study, the Xpert nitinol self-expanding below-the-knee (BTK) stent (Abbott Vascular) is an efficient tool for the treatment of BTK lesions. However, angioplasty (PTA) for treatment of BTK-lesions should be the first approach, and only in case of failure or suboptimal outcomes followed by bail-out stenting with dedicated BTK stents (e.g. balloon-expandable or self-expanding), explained Dr Marc Bosiers, Belgium, in his presentation at CIRSE.

The study was a prospective, multi-centre, non-randomised clinical trial which aimed to assess the safety and performance of the 4F Self Expanding Xpert for the treatment of infrapopliteal lesions in patients with chronic critical limb ischaemia (CLI). Patients with stenotic (>50%) or occlusive BTK arteries were recruited, with a lesion length of <10cm. A maximum of two lesions in one or more BTK vessels was an essential part of the inclusion criteria, along with patients presenting with symptomatic critical limb ischaemia (Rutherford 4–6), and patients with one stenosed and patent artery were also included on the pre-condition that the stenosed artery supplies the wounded area.

Patients excluded were those with lesion lengths that required more than two stent implants, more than two infrapopliteal lesions in the same limb, previously implanted stent(s) or angioplasty (PTA) at the same lesion site, and inflow-limiting arterial lesions that were left untreated.

The study showed that at two years, primary patency was achieved in 54.4% and limb salve in 90.8% of patients (n=94: 46.8% were diabetic). Two-year survival was 71.9%. Stratifying the outcomes for lesion location (proximal vs. distal),  there was no significant difference in primary patency (56.8% vs. 52.3%, respectively). However, limb salvage was significantly better for patients treated with proximal compared to distal BTK-lesions (95.1% vs. 81.1%, respectively).

The study initially ran for 12 months, then was extended for another 12 months. In the 12-month initial report (May 2005 – December 2005), 51 CLI patients were enrolled and the primary endpoint was one-year angiographic patency, as well as absence of >50% stenosis on QVA (Quantative Vessel Analysis). The 24-month extension (May 2005 – Nov 2007) study involved 94 CLI patients, and the primary endpoint was two-year duplex patency and absence of >50% stenosis. Secondary endpoint was two-year limb salvage rate.

In his concluding remarks, Bosiers said, “The Xpert stent is an efficient tool for the treatment of below-the-knee lesions. Limb salvage rates are better for proximal compared to distal lesions.”

AMS not ready for primetime
In a separate presentation, Bosiers discussed the six-month analysis of the Absorbable Metal Stent (AMS) Insight study, which showed that although AMS technology can be safely applied, it did not demonstrate efficacy in long-term patency over standard angioplasty in the infrapopliteal vessels.

The study was designed to investigate the impact of the implantation of AMS in the infrapopliteal arteries, measuring patency by angiography at six months. One hundred and seventeen patients with 149 lesions with critical limb ischaemia (CLI) were randomised to implantation of an MS (n=60, 74 lesions) or stand-alone angioplasty (n=57, 75 lesions) The primary safety endpoint was defined as absence of major amputation and/or death within 30 days after index intervention and the primary efficacy endpoint was the six-month angiographic patency rate as confirmed by core-lab QA.

The three-year outcomes from the Belgian Absolute Trial assessing the safety and performance of the Absolute Self Expandable Nitinol Stent (Abbott Vascular) for the treatment of atherosclerotic lesions of the superficial femoral artery (SFA), showed that the three year primary patency rate was achieved in 77.7% of patients, and limb salvage was 100%. A 1% fracture rate was demonstrated after one year.

The results were presented at the recent CIRSE meeting held in Copenhagen, Denmark, by Dr Herman Schroë, Genk, Belgium. The study, entitled ‘Absolute Self Expandable stent in the treatment of Superficial Femoral Artery atherosclerotic lesions’, was a multi-centre, prospective, non-randomised trial involving 101 patients with symptomatic peripheral artery disease (PAD) due to femoral occlusive disease.
Patients included were those with symptomatic PAD (Rutherford stages 3 to 5), >50% stenosis of the ipsilateral SFA, lesion length >30mm and less then 90mm, and at least one patent crural run-off vessel. The mean length of stenosis was 57mm. Excluded patients were those with, previous ipsilateral femorodistal bypass surgery or ipsilateral SFA stenting, untreated inflow disease, and known intolerance to clopidogrel, aspirin or contrast media.
The results at 12 months showed that primary patency was achieved in 87.3%, secondary patency was achieved in 94%, and limb salvage rate was 100%. Target lesion restenosis (TLR) was 12.7%, target vessel restenosis  was 15.9%, and target vessel revascularisation was 7.3%. It was reported that there was one stent fracture at one year. At three years, primary patency was achieved in 77.7% of subjects, limb salvage was 100%, TLR 22.3%, target vessel revascularisation 18%, and target vessel restenosis was 30.3%.

 “This is the first prospective trial on a homogenous group of treated patients with a prospective follow-up of three years,” commented Schroë. In comparison with the 12 month results from the FAST, Vienna, and RESILIENT trials, primary patency, i.e. freedom from binary restenosis, is achieved in a higher percentage of patients in the Absolute trial (68.3%, 63%, 81%, vs. 87.3%, respectively). The mean lesion length was longer than in the FAST trial, comparable to the Resilient and shorter than in the Vienna trial. Given the “excellent” freedom from binary restenosis result at three years (77.7%). Schroë said that the Absolute stent appears to perform very well in the treatment of atherosclerotic lesions in the SFA also in the long-term. The low fracture rate is a confirmation of the results in other studies and can be explained by the electropolishing and low axial stiffness, he added.

By Florian DickInfrapopliteal disease is the most frequent cause of major amputations and this is also one of the vascular regions where currently some of the most exciting endovascular developments emerge. At the TCT meeting, held in Washington, DC, in October 2008, new approaches to infrapopliteal management were clearly given particular attention.

A totally different approach was presented by Dr David Allie from the Cardiovascular Institute of the South. He claimed that precise vessel sizing to determine exact luminal diameters for optimal stent expansion were considered a prerequisite for coronary intervention for improved outcome; however, they were almost never considered in peripheral interventions. He introduced the Metricath Libra (Angiometrx) which is a low pressure balloon catheter that measures vessel diameter and cross-sectional area to a hundredth mm. In a recent study, 69 infrapopliteal vessels were assessed using this system and no device related complications were reported. “This might be a promising alley to pursue also in the periphery, since we can deploy only the right appliances if we know what dimensions they ideally should have,” Allie said, closing the session.

The Society of Interventional Radiology (SIR) meeting will take place in early March in San Diego, CA, and will be more “interactive and practical”
than previous years, according to Professor Kieran Murphy, Toronto, Canada, who is responsible for the Scientific Programme. He explained, “My job is to work on improving the quality of the science. Overall, I think its becoming more difficult for clinicians to carry out good quality science in the interventional radiology department worldwide because we are under such pressure to increase the volume of patient care, when we have a decrease in our academic time. And this probably reflects a change in the dynamics of American medicine.”

He added that with the onset of National Institutes of Health (NIH) funding cuts, it seems that currently only “professional researchers” are able to receive grants. “I think this means that we really have to work more closely with our European counterparts, CIRSE, and with Canadian, Asian and Australian physicians to collaborate if we are really going to do effective research. It’s not a an easy environment right now in the US to perform high-quality interventional research."

Science programme
Taking this into consideration, Murphy believes that SIR 2009 will be more “user-friendly”, and delegates will have more hands-on experience that will hopefully be more relevant to their daily practices. One of the primary goals of the SIR is to increase the attendance of its members, as currently only 20%-30% of members attend. “We want to make it [the meeting] more relevant and more appealing to our members so they think it is worthwhile attending and that they will get something out of it for their practice,” he said.

“The scientific sessions are where you’ll find the latest innovations in interventional radiology. Presenters will reveal the results of cutting-edge clinical trials, unveil original techniques or enhancements and validations of existing ones, highlight new directions in our specialty, and give you a glimpse of how you’ll practice and care for your patients in the future,”
said Murphy. “The results of basic and clinical research from around the world will be presented in oral and poster formats, and renowned US and international physicians and scientists will moderate the sessions and stimulate discussion and debate,” he added.

New technologies
The launch of new technologies will be an important component of the meeting, with an “explosion of interest in spine intervention” being one of the key features. Murphy explained that new companies, such as Dfine, and Discotech who manufacture high viscosity cement, will be exhibiting. “The development of such cement will make vertebroplasty safer,” he said. Another spine company, Vexim will be showcasing their new interventional spine jack for the treatment of compression fractures associated with motor vehicle trauma.

Awards
As usual, there will be an award ceremony that will take place during the meeting. The awards will be presented to those who have made excellent progress and contributions to interventional radiology.

The SIR Foundation Resident/Fellow Research Award is designed to provide residents and fellows with an opportunity to attend and present scientific research at the meeting.

The Dr Constantin Cope Medical Student Research Award is open to second-, third- or fourth-year medical students who have demonstrated an interest in interventional radiology. The SIR Foundation award recognises the student author of an accepted abstract that best honours the spirit of inventiveness and scientific purity.

The Dr Gary J Becker Young Investigator Award promotes excellence in academic research and is open to all SIR members who have completed fellowship training within the past five years. Candidates are required to submit an application including a manuscript that was published in the last year or a manuscript that is currently under consideration for publication.

There will also be a number of social events, such as an informal opening reception, a student medical brunch, an interventional radiology training dinner (sponsored by Cook), and a clinical associate networking event.

Over the last two decades, the management of high-risk cirrhotic patients has developed significantly, with advances in pharmacologic, endoscopic and interventional radiologic treatment options. Since its introduction over a decade ago, the transjugular intrahepatic portosystemic shunt (TIPS) placement has become a fundamental treatment option.

Despite these advances, there still remains a high mortality rate of 20%–40% for high-risk variceal bleeders; and that is including the administration of rescue TIPS placements, said Dr Angelo Luca, Istituto Mediterraneo, Italy, at this year’s CIRSE meeting, Copenhagen, Denmark. Treatment failures are usually caused by repeated endoscopic therapy, multiple transfusions, frequent infections, and further liver deterioration, he added.
In a multi-centre, European randomised, controlled trial, Luca and colleagues evaluated whether an early decision to use TIPS with PTFE-coated stents in high-risk variceal bleeders improves the short- and long-term outcome as compared with the current recommended treatment using combined pharmacologic and endoscopic therapy.

Study design
In nine European centres, 63 high-risk cirrhotic patients with acute variceal bleeding (AVB), treated with vasoactive drugs and endoscopy, were randomised to receive PTFE-TIPS within the first 72 hours after admission (n=32) or to current recommended therapy (n=31). The primary endpoint was failure to control acute variceal bleeding and to prevent significant variceal rebleeding within in one year. Secondary endpoints included survival, development of hepatic encephalopathy, days in the intensive care unit (ICU), percentage of time of follow-up at the hospital, and the use of alternative treatments.
Patients included were those with liver cirrhosis, active bleeding from oesophageal or gastric varices, and Child-Pugh B plus active bleeding at endoscopy under pharmacological treatment or Child-Pugh C (<13). Patients excluded presented with hepatocellular carcinoma (HCC) beyond Milano Criteria, portal vein thrombosis, fundal or ectopic gastric variceal bleeding, or previous TIPS or drugs plus endoscopic therapy.

Results
According to the results, 14 patients in the medical-endoscopic group vs. one patient in the PTFE-TIPS group reached the composite endpoint (p<.01). At one-year, actuarial probability of remaining free of the composite endpoint was 50% vs. 97% (p<.001), respectively.
Noteworthy, seven patients in the medical-endoscopic group received PTFE-TIPS as rescue therapy, and 16 patients died (12 in the medical-endoscopic group vs. four in the PTFE-TIPS group) (p<.02). One year actuarial survival was 60% vs. 86% in the medical-endoscopic and PTFE-TIPS groups, respectively (p<.01)
Luca added that one-year actuarial probability of new or worsening ascites were 33% vs. 13%, respectively (p=.11), and that of encephalopathy was 40% vs. 28% (not significant).
The complications observed included bleeding, severe infection, liver failure, Hepatorenal Syndrome, and arrhythmia, but were lower in the PTFE-TIPS group (Table 1).

Conclusions
“In high-risk cirrhotic patients admitted for acute variceal bleeding, early treatment with PTFE-TIPS is associated with marked reductions in rebleeding and mortality in comparison with the current gold standard therapy,” stated Luca. “Early treatment with PTFE-TIPS should be the treatment of choice in high-risk patients,” he concluded.

In an intensive ‘Special Session’ taking place at CIRSE meeting 2008, four prominent interventional radiologists discussed their views on how to promote interventional radiology (IR) to patients and referring physicians according to their respective therapy areas.

Chaired by Drs Marc Sapoval, France, and Peter Haage, Germany, the session began with Dr Siegfried Thurnher, Hospital Brothers of St John of God, Vienna, Austria, discussing the importance of IR marketing, the basic tools to drive and deliver information to the public, the importance of teaching diagnostic radiologists, and how to start a marketing programme.

Challenges of IR
In his opening remarks, Thurnher explained that increased competition among healthcare providers, the advert of specialties and sub-specialties, and a growing number of health-conscious consumers mean medical professionals of all persuasions can benefit from a well-executed marketing strategy.
“In general, few medical services speak for themselves,” he said. “Their providers must heavily rely on marketing communications to give prospects something firm to evaluate.”
A central issue for IRs is that knowledge about their treatment options is scarce among the general public, patients and referring physicians. “IRs will find it not only important but mandatory as they establish clinical practices and work to change existing perceptions in the healthcare system,” stated Thurnher. “A good marketing strategy is very important to make interventional radiologists’ service visible and keep the prospect comfortable.”
According to Thurnher, ‘Identity’ is one of the biggest challenges for IRs. He believes that currently, an inaccurate impression (brand identity) exists in the medical community. “It is important for all customers to know the difference between diagnostic specialists and IRs. Don’t let competitors [e.g. vascular surgeons] define IR. If IRs want to advance toward the perception of a clinical specialty, they need to change this misconception, particularly with primary care doctors,” he said.
Following this, Thurnher discussed the importance of a generic ‘name’ for IR. He said that because IR offers a broad range of treatment alternatives, therapies can not be promoted under one unique name. He suggests creating a name, such as ‘Centre of Excellence for Minimally Invasive Therapy’, or ‘Centre of Excellence for Spinal Interventions’ etc.
Another important challenge is to “take control of patients”. “IRs must gain control of patients to the same extent as other sub-specialties to compete on equal terms by setting up a practice,” said Thurnher. “They must gain the respect and confidence of primary care doctors from whom they wish to receive referrals.”
Additionally, he discussed the importance of defining target groups, developing a marketing plan for setting up a practice, and developing marketing tools. He concluded, by stating “In recent years, IRs have been faced with the fact that other specialties have taken on invasive procedures. Other specialists have marketed their power to control patients with the result being a threat of extinction of IR referral practice. To compete effectively, IRs must market themselves to prospective patients to achieve a public profile that will generate patient-initiated visits for care. Advanced marketing has become very important to make IRs service visible and to assure success in the future.”

How to attract patients for UFE
Dr Thomas Kroencke, University Clinic Charite, Berlin, Germany, discussed the role of the internet and media as a key factor to direct the patient to the IR suite. He also stressed the importance of educating GPs and gynaecologists about uterine fibroid embolization (UFE).
“The range of treatment options for symptomatic fibroids has increased considerably within the last two decades, however, information about non-surgical alternatives such as UFE is still not available to most women in Europe,” said Kroencke.
Traditionally, IRs have used in-house education of physicians to obtain referrals for their procedures. “Although excellent cooperation with the gynaecology department is an essential pre-requisite to offering UFE, it does not automatically lead to increased awareness among patients and office-based gynaecologists and therefore to higher numbers of referrals.”
Kroencke’s view is that gynaecologists should be targeted directly through information events that are organised by IRs, and that IRs need to position themselves as clinical partners with long-standing expertise in minimal-invasive image guided techniques. He also states that targeting GPs is worthwhile, as they are often trusted partners of women with symptomatic fibroids and have a deep understanding of quality of life issues.
According to Kroencke, using the media is also an effective communication tool to educate the public. It is a low cost method that may be challenging. However, information will be reached to a wider population and hence draw attention to procedures such as UFE. Another effective tool is to create patient information leaflets, develop a user-friendly website with clear and concise simple facts and diagrams, and attend patient groups and forums, or internet-based forums, to allow women to speak with other fibroid sufferers.

How to attract patients for vertebroplasty
Excellent knowledge of the procedure, education of colleagues and patients, and patient follow-up are some of the essential obligations for an IR wishing to promote vertebroplasty as an alternative treatment option, said Professor Afshin Gangi, Strasbourg, France. He also indicated that the role of modern diagnostic imaging is a key factor to select and direct the patient to the IR suite.
“It is important for IRs to know the indications, contraindications, technique, and precautions for this procedure, as well as having the best equipment and most importantly, taking care of the patient from the beginning until the end,” Gangi said. He also stressed the importance of working closely with diagnostic radiologists, explaining the importance of IR to them and making them aware that there are more options when it comes to treating vertebral fractures.
Furthermore, Gangi indicated that multidisciplinary communication is also vital when it comes to IR. Encouraging clinicians from the oncology, bone and spine, and pain management departments to take part in multidisciplinary meetings will help with education of these team members and hence further promote the use of vertebroplasty.

How to attract patients for PVD interventions
Peripheral artery disease (PVD) is a prevalent disease in older individuals with lower extremity PVD present in 5% of those over 50, 10% over 60, and 20% over 70, explained Dr Timothy Murphy, Rhode Island Hospital, Providence, RI.
“What is happening in the US with regard to delivery of interventional revascularisation services?” asked Murphy. He explained that using the CPT (Current Procedural Terminology) procedure code 37205, which is for stent placement in the first peripheral vessel, the overall volume increased 2.4 fold, from 45,073 to 108,450 procedures from 2000 to 2006. When comparing 2000 to 2006, there was a 680% increase by vascular surgeons, a 177% increase by cardiologists, and a 34% by radiologists.
Continuing, he said “Growth among surgeons has been at a compounded annual rate of 30.3% since 2000. Radiologists’ market share decreased from 49% to 28%, and vascular surgeons’ market share increased from 10% to 27%.”
Murphy asked, “How did this happen?” and explained that over ten years ago, vascular surgery and interventional cardiology leadership started initiatives to compete for peripheral artery disease (PAD) interventions. “Cardiologists generated procedures that wouldn’t have existed and vascular surgeons diverted referrals that traditionally went to IRs,” he said. Many radiologists could have strengthened their position if they didn’t provide services to referring doctors as technicians, but to patients as doctors; didn’t establish ‘joint ventures’ with surgeons that involved training them; and didn’t agree to allow vascular surgery fellows to train with them, he added.
In discussing referrals, Murphy said that PVD referrals can be accepted by radiologists only if they have clinical offices and accept referrals for disease management and not just for procedures. “Once this is in place, calling on potential referring doctors to recommend services is possible.” He also highlighted the importance of obtaining an office that is not part of a hospital nor in the radiology department.
“Differentiating yourself from competition by offering comprehensive vascular diagnosis, consults, and follow-up is an important step forward for IR. Also, never practice like a technician. Ideally you should refuse to accept consults or referrals unless you are the primary vascular specialist, that is, get the referring community educated to you serving in that role,” he concluded.

In a head-to-head comparison of the S.M.A.R.T. Control Nitinol Stent (Cordis) with the Luminexx 6F Stent (Bard) for the treatment of long TASC C and D superficial femoral artery (SFA) lesions, more fractures in total and significantly more fractures of the potentially clinically relevant Types III and IV were observed in the Luminexx group.

The multi-centre (12 sites), prospective, randomised, two-arm-investigation study aimed to assess the performance of both stents, as determined by binary (≥50%) restenosis rate at 12 months post-procedure. There were 199 patients enrolled and randomised 1:1 (S.M.A.R.T: n=96 and Luminexx: n=103).
Dr Stephan Duda, Berlin, Germany, presented the study at CIRSE, and explained that patients recruited were aged between 30 and 80 years, with symptomatic leg ischaemia. Lesion length ranged between 5cm and 22cm and vessel diameter ranged between 4mm and 6mm. Patients excluded were those who had an aneurysm in the SFA or popliteal artery, poor inflow inadequate to support a femoral popliteal bypass graft, and significant vessel tortuosity.
The results demonstrated that more stents were used in the S.M.A.R.T. group, with half the patients (50%) receiving two stents compared with 44.7% of patients receiving two stents in the Luminexx group (Figure 2).
In terms of stent fractures, the Luminexx group experienced more fractures (27.7%) in total compared with 21.0% in the S.M.A.R.T. group. The occurrence of single strut fractures (Type II) and complete transverse linear separation without stent displacement (Type III) was significantly higher in the Luminexx group compared with the S.M.A.R.T. group (20.9% and 17.6% vs. 12.5% and 4.5%, respectively). However, ABI and Rutherford class were similar in both groups at 12 months.
To conclude, Duda explained that patients treated with the S.M.A.R.T. stent for TASC C and D lesions had longer lesions and required a significantly higher number of stents, and more fractures of types III and IV were observed in the Luminexx group. Therefore, he said, due to its longitudinal compliance and flexibility, the S.M.A.R.T. nitinol stent appears to perform better than the Luminexx stent in treatment of long SFA lesions.

STROLL Trial to involve 250 patients at 25 US centres
The first patient enrollment in the STROLL trial was recently announced by Cordis, which will evaluate the safety and efficacy of the S.M.A.R.T. Nitinol Self-Expandable Stent System in treating patients with superficial femoral artery (SFA) disease. The STROLL trial will support a planned PMA filing with the US FDA that, if approved, will allow Cordis to market the S.M.A.R.T. Stent for this indication.
The STROLL trial will enrol approximately 250 patients at 25 centres in the US. The primary efficacy endpoint is no significant reduction of flow detectable at 12 months follow-up visit, and no further clinically driven target vessel revascularisation performed in the interim. The primary safety endpoint is 30-day freedom from all causes of death, index limb amputation and target lesion revascularisation through 30 days.
“Peripheral artery disease (PAD) remains significantly under-diagnosed and leads to increased mortality and morbidity as well as lifestyle and fitness impairment,” said Dr Charles Botti, MidWest Cardiology Research in Columbus, Ohio. “I look forward to better understanding the impact that the S.M.A.R.T. Stent may have in the treatment of SFA disease.” Botti performed the procedure on the trial’s first patient.