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1 Header Review 2013

2 LINC Review Publishing and Production MediFore Limited Course Director Dierk Scheinert Editor in Chief Liam Davenport Editors Peter Stevenson and Rysia Burmicz Design Peter Williams Industry Liaison Manager Cheryl Cagiola Head Office 19 Jasper Road, Crystal Palace, London SE19 1ST Telephone: +44 (0) Copyright 2013: LINC and Provascular. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, transmitted in any form or by any other means, electronic, mechanical, photocopying, recording or otherwise without prior permission in writing of LINC or Provascular. The content of LINC Review does not necessarily reflect the opinion of the LINC 2013 Course Directors or the LINC Organisational Committee.

3 Introduction The 9th edition of the Leipzig Interventional Course took place at Trade Fair Leipzig on January A record 4,028 participants from more than 70 countries attended this year s meeting from across the entire spectrum of the interventional vascular field. LINC is dedicated to advancing the clinical assessment and treatment of patients with complex vascular disease through an interdisciplinary discussion of the latest scientific and clinical discoveries and novel endovascular techniques. LINC returned in 2013 with a wide-ranging and comprehensive programme designed to develop an increased understanding of the broad spectrum of endovascular therapy. Even more so than in previous years, experts, clinicians, researchers and, this year, nurses from all over the world gathered at this leading international forum to share their expertise and drive the advancement of interventional medicine into the future. Over four days, invited experts presented a range of state-of-the-art lectures, clinical trial reviews, controversial interdisciplinary debates and live cases that explored the entire spectrum of endovascular topics and provided an opportunity for candid discussion. As with previous LINC meetings, live case transmissions remained a core element, with more than 90 live cases transmitted from 11 international sites. Leading centres in Germany, Italy, the USA and Brazil joined the LINC symposia during scheduled live video link-ups that brought further expertise, a greater understanding of the applicability of technologies, and tips and tricks on technique, to the forefront of the meeting. Interaction with other endovascular meetings from across the world remained a key component of LINC, and the course deepened its collaborations with Vascular InterVentional Advances (VIVA) and the Charing Cross (CX) Symposium. In addition, LINC resumed its transatlantic collaboration with the International Symposium on Endovascular Therapy (ISET) meeting in Miami. Transcatheter Cardiovascular Therapeutics (TCT) brought a series of Deep Dive sessions, as well as the TCT session on carotid interventions, and there was a brand new collaboration with CICE (International Conference on Endovascular Therapy). A new format for 2013 was the Global Exchange Forum, in which renowned experts from around the world presented challenging case reviews. Supported by pre-recorded and live cases, region-specific experiences and techniques were discussed. Also new for this year were Nurse Sessions developed in cooperation with cath lab nurses and technicians to provide maximum correlation with daily routine. The organizers of LINC 2013 are delighted to present LINC Review 2013, which aims to provide the reader with an overview from some of the hundreds of presentations, clinical trial findings, live case transmissions and collaborative sessions from across the four days of the conference. The organizers of LINC 2013 would like to thank all delegates and industry sponsors for their continued support, and look forward to seeing you in Leipzig for LINC LINC Asia-Pacific LINC Asia-Pacific is a multidisciplinary, educational course covering all fields of peripheral arterial interventions, including carotid, renal, femoral and below the knee procedures, as well as stent-grafting for AAA, TAA and aortic dissections. The course is practice oriented, with special emphasis on complex revascularization techniques and interdisciplinary discussion. LINC Asia-Pacific 2013 will take place from March, 2013, in Hong Kong. LINC Review 2013: Copyright LINC Organizational Committee. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, transmitted in any form or by any other means, electronic, mechanical, photocopying, recording or otherwise without prior permission in writing from the LINC 2013 Organizational Committee. The content, views, comments and opinions expressed within does not necessarily reflect the opinion of the LINC 2013 Course Directors and the LINC 2013 Organizational Committee. Contents Society and association accreditation 4 LINC in numbers 5 The latest innovations and technical developments 6 Collaborations at LINC: VIVA 13 What happens after DEB vessel transfer? 14 Onyx liquid embolic system showcased at LINC 17 Taking just one shot to treat renal denervation 19 Scrub in with the Experts: Complex cases 22 Vanguard to clinical routine in revascularisation 26 A better future with rotational thrombectomy 28 The Great Debate: Leave nothing behind? 30 A DEFINITIVE commitment in PAD restenosis 33 Leaps and bounds in below-the-knee therapy 36 A matter of balance for innovative EVAR devices 39 Showing promise in SFA and popliteal aneurysms 43 Evolution to revolution in the iliac and SFA 46 To refine and define our practice MOTHER registry 50 Dealing with complex occlusions live 52 LINC 54 LINC 58 Why I do what I do for SFA occlusions 67 Challenging Case LINC 72 Digital LINC 73 LINC LINC LINC 2013 In pictures 78 3

4 Society and association accreditation LINC 2013 was accredited by: The Sächsische Landesärztekammer with 24CME points. The Swiss Society for Angiology with 30CME points. The Dutch Association for Surgery with 20 accreditation points in Category I LINC 2013 was endorsed by The Belgian Society for Vascular Surgery The Italian Society of Vascular and Endovascular Surgery ISET. The Internation Symposium on Endovascular Therapy The National Education Course for Vascular Intervention and Medicine LINC 2013 was under the patronage of: The German Cardiac Society The German Society for Angiology The German Society for Vascular Surgery and Vascular Medicine LINC 2013 Organisation and production 4 Congress production Provascular GmbH, Sonnenleite Heroldsbach Germany dr.hornung@provascular.de Phone: Fax: Congress organisation Congress Organisation and More GmbH Romanstraße München Germany info@cong-o.de Phone: Fax: AV support mediaventures St. Jozefstraat Merelbeke Belgium info@mediaventures.be Phone: Fax: LINC Review MediFore 19 Jasper Road Crystal Palace London SE19 1ST United Kingdom mary.kennedy@medifore.co.uk Phone: +44 (0)

5 LINC in numbers Germany USA Belgium Italy The Netherlands United Kingdom Spain Poland France Switzerland Sweden Austria Iran Brazil Czech Republic Turkey Egypt Finland Denmark Israel Greece Norway Portugal Japan Russia Saudi Arabia Slovenia China South Africa Ireland Ukraine Venezuela Slovakia Bulgaria India Latvia Argentina Lebanon Croatia Australia Colombia Singapore Thailand United Arab Emirates Belarus Canada Taiwan South Korea Luembourg Monaco North Korea Lybia Mexico Serbia Hungary Pakistan Romania Bahrain Belize Bermuda Bhutan Cprus Estonia Georgia Iraq Kazakhstan Morocco New Zealand Oman Peru Tunisia Distribution of medical professionals by country Distribution of medical professionals by specialty Vascular Surgeons 45% Angiologists/ Cardiologists 27% Interventional Radiologists 26% Attendance and percentage increase LINC 2013 had a record 4,028 participants from more than 70 countries 1, % , % , % , % , % , % 4, %

6 The latest innovations and technical developments ope A balanced selection of live procedures, presentations and featured research reflected the nature of LINC 2013 in the opening session, which commenced with four topics under the theme of new data and technological development. LINC Course Director Dierk Scheinert (Leipzig, Germany) was joined by session moderators Marianne Brodmann (Graz, Germany), Giovanni Torsello (Münster, Germany), Stanislav Bartus (Krakow, Poland), Ramon Varcoe (Sydney, Australia) and Varinder Singh Bedi (New Delhi, India) to kick off the debate over novel techniques and tools. Kicking off the live case programme with endovascular aortic repair Commencing the first topic of innovations and new insights in endovascular aortic repair, Andrej Schmidt, together with his colleagues at Park Krankenhaus in Leipzig, presented a case of chronic aortic dissection with the notable challenge of a steep aortic arch, as well as a very short landing zone between the subclavian and carotid arteries. This necessitated debranching before the thoracic endografting procedure could be performed. The 55-year-old patient was suffering from arterial hypertension and obesity and, when the patient was admitted to hospital urgently before Christmas with acute thoracic pain, the team performed a CT angiography, which indicated a type B aortic dissection. Present on Dr Schmidt s team was Daniela Branzan, who described the case pathophysiology: The dissection membrane goes to the visceral segment; the celiac trunk is almost occluded; the super mesenteric artery, coming from the true lumen, is also compromised. Treatment was refused before Christmas. There were no clinical signs of critical ischemia, but the patient lost her right kidney, concomitant with an increase in creatine level, although there was malperfusion in left kidney. We have prepared the patient for thoracic endografting. We have performed a small debranching operation carotid subclavian bypass on the left side in order to increase the landing zone for the stent graft. The landing zone was accessible via two arterial punctures in the brachial and right groin. The procedure was performed percutaneously, under general anaesthetic, and two imaging probes were preloaded to avoid arterial cutdown. After inspection of the bypass work, the arch anatomy and the occlusion in the proximal subclavian, Dr Schmidt then advanced the pigtail catheter, which originated from the right arm, down into the area of the occluded visceral arteries. With the aid of contrast injection to ensure that it remained in the true lumen, the catheter was guided further down until he could hook it onto another pigtail catheter rising from the right groin. In this way, it was possible to safely ascend while remaining in the true lumen, and this was confirmed with intravascular ultrasound. A stent was then prophylactically implanted in the mesenteric artery via the arm before the thoracic stent placement. Dr Schmidt noted that, although this was perhaps not acutely necessary at the time of the procedure, in the possible case of a persistent stenosis in the mesenteric artery following the placement of the non-covered stent in the visceral arteries, it would be difficult to then gain access to this region in order to implant a stent. Returning to the subclavian, under rapid pacing to lower cardiac output, a Zenith graft (Cook Medical, Bloomington, Indiana, USA) covered stent was placed across the subclavian in order to close its proximal entry. Dr Schmidt commentated: I want to go to the left common carotid. It was not easy getting the stent graft up because of the very steep arch. This stent has a late release mechanism that will help us to avoid the windsock effect [graft displacement before deployment is completed] which we will still have a little bit with the pacemaker. Having covered the proximal entry to the subclavian, the team proceeded to place non-covered stents distally in order to achieve an open true lumen in the osteum of the visceral arteries down past the renal artery, opting for 36mm (164mm long) rather than 46mm stents due to the small anatomy of the female patient. Describing the procedure, Dr Schmidt said: The concept generally is that you go down to the aortic bifurcation, so we implanted another stent down to the bifurcation; it did not push the membrane away completely distally, but there is still a chance that it will remodel over time and open up. The team concluded by once more inspecting the oversized graft over the proximal subclavian, which had indicated minor migration due to the steep aortic arch, and had compressed by a small amount, but nevertheless formed a good proximal seal over the osteum of the subclavian. Continuing on the theme of new insights in endovascular aortic repair, Christoph Nienaber (Rostock, Germany) discussed longterm results from the INSTEAD trial, focusing on the reemergence of EVAR as a treatment for uncomplicated type B dissections. While they may be called uncomplicated, such cases are far from stable in the long term, with new late acute scenarios emerging from extension of the false lumen. Professor Nienaber explained that isolation of the false lumen leads to remodelling and, if successful, ensures long term stability; TEVAR in type B dissection sets the stage for this remodelling process and may take on an integral role in all cases. Two groups within type B dissections have emerged from registry data: a high risk and a lower risk group, with the latter not obviously demonstrating evidence of malperfusion. In both groups, acute symptoms such as malperfusion can be relieved. In the longer term, endovascular techniques can also be employed in order to induce the shrinking of the false lumen 6 This stent has a late release mechanism that will help us to avoid the windsock effect which we will still have a little bit with the pacemaker. Andrej Schmidt (Leipzig, Germany)

7 n LINC 2013 analysed after two and then five years. Many patients underwent elective stenting as a result of complications. For patients implanted in the one-year recruitment period, most were recruited and treated within an initial window of three months in both groups. In terms of morphological changes, 90% of patients demonstrated evidence of remodelling after two years, with reconstruction of the true lumen and complete abolition of the false lumen on the right hand side, at least in the thoracic aspect of the aorta. 1 At two-year follow-up, there was no difference between the medication-only and medicationplus-stenting groups in terms of mortality at 24 months. However, analysis after both one and two years indicated a 20% crossover to elective stenting due to late complications. Findings were similar at two-year follow-up with respect to aorta-related mortality and reintervention and late complications in both groups. The five-year extended followup (INSTEAD-XL), demonstrated that, after three, four and almost five years, there was no further mortality or advancement beyond Continued on page 8 and the remodelling of the entire aorta. In complicated, high risk cases, there is evidence supporting the use of endovascular TEVAR by various techniques. Professor Nienaber noted that lower risk, so-called uncomplicated type B dissections have a better prognosis than complicated cases. In order to determine the optimal course of treatment in uncomplicated cases, the INSTEAD trial, a randomised study based on available data from patient procedures and follow-up during the 1990s, compared medical management alone with elective stenting plus medication. The study, involving 140 cases, was conducted in seven European centres, designed to be Isolation of the false lumen leads to remodelling and, if successful, ensures long term stability Christoph Nienaber (Rostock, Germany) 7

8 The latest innovations and technical developments ope Continued from page 7 the first-degree endpoint. Regarding cardiovascular death or aortarelated mortality, ongoing mortality was a hallmark of the non-stented group, with no evidence of vascular mortality in the initially stented group. The initially stented group also showed a smaller increase in the parameters of progression (reintervention, related death and related complications) compared to non-stented patients, and this was significant at various time points. The INSTEAD and INSTEAD-XL results are highly comparable to the study of cases in the International Registry. In this study, the non-stented group showed increased evidence of morphological changes, with increasing diameter of the aorta, which may lead to rupture. A silky smooth solution for neuroprotection in carotid revascularisation Carotid revascularisation was the second of four themes in the opening session, and Sumaira MacDonald (Newcastle, UK) discussed how the MICHI (Silk Road Medical, Palo Alto, California, USA) direct carotid access system can overcome the shortcomings that marred the success of direct carotid artery stenting (CAS) and endarterectomy (CEA) in the past, mitigating these and other risks associated with transfemoral access. The case for direct carotid artery access competes with the technique of transfemoral access, and its hazardous reputation has endured amid complications such as myocardial infarction, despite the procedure having been under refinement over the past 60 years. Several major unmet needs persist in CAS and CEA, with the CREST study demonstrating an increase in CAS periprocedural stroke risk compared with CEA (4.1% versus 2.3%); conversely, CEA is associated with an increased risk of morbidity (by myocardial infarction, 2.3% compared with 1.1% in CAS) and cranial nerve injury (4.8% versus 0.3% in CAS). 2 Subclinical concerns include long-term new white brain lesion rate, which was measured during the ICSS sub-study with diffusion weighted (DW) MRI. 3 Addressing the notion that procedural minor stroke is a greater risk with carotid artery stenting than with endarterectomy, lesions were analysed by Figure 1: MICHI Neuroprotection System frequency as well as volume. The primary analysis was a one-to-one randomised trial in 1,713 purely symptomatic patients in a number of centres throughout the UK. In a subset of 231 patients, new white lesion frequency on DW-MRI was measured pre- and post-stenting and endarterectomy. The new white lesion rate for endarterectomy was 17%, compared with the 50% that occurred in transfemoral filter-protected carotid stenting cases. Interestingly, however, further evaluation of lesion volumes in endarterectomy versus stenting patients demonstrated that, while stenting leads to more lesions of smaller volume, endarterectomy is followed by fewer but larger lesions, with the total affected brain volume in both patient popula- 8 The MICHI system represents a paradigm shift in the management of carotid artery disease Sumaira Macdonald (Newcastle, UK)

9 n LINC 2013 tions being equal. Work that will be presented later in 2013 will demonstrate the significance of white matter lesions, with carotid stenting patients who have new white matter lesions incurring a higher frequency of ischemic attack and stroke within five years of the procedure than those who were lesion negative; however, the risk of stroke alone was not significantly increased. The Silk Road MICHI neuroprotection system is an 8 French outer diameter arterial sheath and an 8 French outer diameter venous return sheath, with a flow controller in between and a very wide core low-resistance tubing to connect the two (see Figure 1). The arterial sheath is inserted with a 2cm transverse surpra-clavicular incision between the sternocleidomastoid muscle. Very high flow rates can be achieved, as well as flow-reversal, with the option of switching to high flow rate, low flow rate, and stop-flow for contrast injection. This system allows reversal without the manipulation of the external carotid artery, which is not the case in the other proximal protection systems available. Speaking of procedural results, Dr MacDonald explained that high flow rate/flow reversal timing was approximately 12 minutes and tolerance to reverse flow was good. In this first-in-man study, the primary endpoint was major stroke, death or myocardial infarction, but none of these events occurred. One contralateral minor stroke was observed, which was adjudicated to be unrelated to the procedure or the technique. Two cranial nerve injuries manifested, expressed as hoarseness due to the transverse low incision on the carotid artery above the clavicle, which may implicate the vagus and the laryngeal nerves. Dr MacDonald stressed that this is not the same scenario as Figure 2 cranial nerve injuries in the carotid bifurcation approach for classic endarterectomy, with the expectation that the rate of injury will be lower for this hybrid approach. Other carotid interventional strategies demonstrate a broad range of new white matter lesion occurrence. ISIS endarterectomy, where protection is achieved via clamping, is associated with a 17% new white lesion rate. 3 Transfemoral protection does not approach this level of control of the microembolic burden, with new white matter lesion rates of up to 73% 87% for filter protection from a transfemoral route. Proximal embolic protection devices such as the Mo.Ma (Invatec, Bethlehem, Pennsylvania, USA) demonstrate a marginal improvement; however, only with high flow rate flow reversal and avoid the arch, do rates appear commensurate with endarterectomy (see Figure 2). Early results on renal denervation from Poland Renal denervation is a leading edge procedure that has the potential to reduce cardiovascular risk by addressing hypertension, and Dr Bartus spoke about preliminary results from the Polish registry of renal denervation on behalf of investigators from 11 Polish centres. The study design reflected that of the Symplicity HTN-1 and HTN-2 clinical trials (Medtronic, Fridley, Minnesota, USA), 4-5 with measurements of 24-hour automatic ambulatory blood pressure, as well as parameters of diabetes mellitus. Dr Bartus described the patients baseline characteristics, which were typical in comparison to other studies and included almost 50 mostly young patients, 30% of whom were diagnosed with obesity, and 30% with diabetes mellitus. Baseline hypertension measurements indicated relatively high blood pressures, and similar indications were given by 24-hour ambulatory blood pressure measurement. Over 80% of patients received more than four drugs. Forty per cent did not demonstrate reduced physiological blood pressure during the night. The anatomy of the renal arteries was typical 5.8mm in internal diameter and 3cm in length. Preliminary follow-up was performed at one and three months with both resting and ambulatory diastolic and systolic blood pressure. Dr Bartus described that, after one month, the decrease in systolic blood pressure was approximately 17mmHg and diastolic blood pressure was decreased by approximately 5mmHg; this was confirmed at three month follow-up. The number of patients with very high blood pressure was decreased, although 25% of patients were non-responders. Those without nocturnal reduced blood pressure and those with very high blood pressure responded better than other subgroups to treatment. Measures of 24-hour ambulatory blood pressure demonstrated a decrease in systolic blood pressure Continued on page 10 Operator experience did not influence [renal denervation] procedural results Stanislav Bartus (Krakow, Poland) 9

10 The latest innovations and technical developments ope Continued from page 9 by 13mmHg, and diastolic by 7mmHg. There was a decrease in the number of patients with very high blood pressure, but 17% of patients were non-responders. Female patients and those without nocturnal reduced blood pressure responded best to treatment. Dr Bartus highlighted that operator experience did not influence procedural results, indicating that the technique has the potential to be taught easily and is highly transferable. The Polish registry found no new complications associated with the procedure; most were associated with the puncture site, which reflected the findings of the HTN-2 study. Starting the debate over leaving nothing behind A major area of discussion at LINC this year was the fourth theme of the opening session Leaving nothing behind the new paradigm for peripheral interventions? This important concept is of growing significance in light of the evolution of drug-eluting balloons and related endovascular techniques, and new results from four separate studies were presented by Karl-Ludwig Schulte (Berlin, Germany), Lawrence Garcia (Boston, USA), Thomas Zeller (Bad Krozingen, Germany) and Dierk Scheinert (Leipzig, Germany). Professor Schulte began with a summary of the 12-month Biolux P1 (Biotronik, Berlin, Germany) results of the Passeo-18 Lux, comparing this with uncoated PTA catheter. The Passeo-18 Lux is a balloon coated with paclitaxel and excipient BTHC (Butyryl-tri-hexyl- Citrate), which maintains the drug in a microcrystalline structure, an innovative insertion aid that eases the handling of the device and protects the coating. A prospective international Figure 3: Key study design elements multicentre trial with one-to-one randomisation, Biolux P1 included 60 subjects, with six-month data already presented at EuroPCR These demonstrated reduced angiographic late lumen loss (LLL; (p = 0.033) in the Passeo-18 Lux (in-segment LLL = 0.51 ± 0.72mm) against the uncoated PTA catheter (in-segment LLL = 1.04 ± 1.00mm). Binary restenosis was also reduced (p = 0.048) in the Passeo-18 Lux arm with respect to the uncoated PTA catheter (11.5%, 34.6% respectively). Due to the loss of between four and five patients in each group, the results failed to reach significance at 12 months despite a clear trend. However, target lesion restenosis (TLR) rate was lower in the drug-coated balloon group, although it did not reach significance. 65% of patients showed an improvement in Rutherford classification in normal balloon procedure, versus 72% under drug-coated balloon therapy. Professor Schulte was confident that these results would attain statistical significance, with greater numbers of patients being recruited for the next study. The second piece of featured research was a 12-month update of the Definitive LE (Determining the Effectiveness of the Silver- Hawk/Turbohawk Peripheral Plaque Excision Systems for the Treatment of Infrainguinal Vessels/Lower Figure 4: Primary patency in subgroups Extremities) study, presented by Dr Garcia. It is a 47-centre European/ US, prospective non-randomised study enrolling 800 patients, demonstrating the efficacy of directional atherectomy (see Figure 3). The patient sample (n=799), was broken down by claudication (Rutherford clinical category 1 3; n=598) and critical limb ischemia (CLI) (Rutherford category 4 6; n=201). Outcomes were patency for claudicants, and amputation freedom at 12 months for CLI patients. Diabetic patients and non-diabetic patients were also compared within the claudicant group. There were 1,022 lesions in 799 patients, with a mean lesion length of 7.4cm, and occlusions were present in a higher proportion of 10 Diabetics perform equally well when treated with directional atherectomy to non-diabetics for claudicants Lawrence Garcia (Boston, USA)

11 n LINC 2013 CLI patients. The majority (66%) of lesions occurred in the superficial femoral artery (SFA), with less than 20% occurring each in the popliteal and infrapopliteal arteries. The distribution of these lesions between claudicants and CLI patients was by no means equal, with 72% in the SFA in claudicants and 48% in CLI patients. Infrapopliteal lesions were more common in CLI cases, at 34% versus 13% in claudicants. Primary patency in claudicants at 12 months indicated an 82% success rate, with no difference between diabetic and non-diabetic patients. Freedom from amputation in CLI was 95%. Stenoses showed greater patency at 12 months compared with total occlusions in both claudicants and CLI patients, and shorter lesion lengths demonstrated greater patency at 12 months (see Figure 4). Procedural complications included distal embolisation (in 3.8% of cases, of which 1.5% required intervention); dissection (2.3%), and perforation (5.3%), with a total intervention rate of 7.6% (n=61). These data were comparable to similar studies, although lesion length variability made direct comparisons difficult. In terms of functional outcome at 30 days and 1 year, both Walking Impairment Questionairre (WIQ) and EuroQol 5D index (EQ-5D) were in favour of revascularisation throughout the period. Compared with other trial data, data are very comparable for <4cm and >4cm lesions. Although leaving nothing behind is a compelling idea, safety and efficacy must remain the principle concerns of any procedural comparison. Thomas Zeller presented data on comparisons of drug-eluting balloons (DEB) with drug-eluting stents (DES) in long femoropopliteal lesions, noting that this topic had not yet been studied in depth, while both technologies have shown promise in the treatment of SFA disease. With different diverse lesions requiring different approaches, it is therefore necessary to understand how DEB and DES perform under different scenarios. Professor Zeller described recent bare metal stent results, which indicate that patency rates decrease Continued on page 12 DEB and DES appears to have similar safety and efficacy outcomes in lesions >10cm Thomas Zeller (Bad Krozingen, Germany) 11

12 The latest innovations and technical developments with increasing lesion length. Citing an example, he said that the Zilver PTX (Cook Medical, Bloomington, Indiana, USA) trial demonstrated that the drug-eluting stent is superior to the bare metal stent, although only in the region of 5 6cm lesion lengths. However, data from the Zilver PTX registry suggest that the drug-eluting stent performs well at longer lesion lengths (up to 15cm), as is the case for drug-eluting balloons. Comparing differences at baseline within a non-randomised cohort necessitated the use of propensity score analysis, in order to minimise the differences between Figure 5 treatment groups that may arise due to the imbalance of baseline core variates. Results indicated that no statistically significant differences existed in patient age, gender, and various comorbidities; however, differences were identified in lesion characteristics alone regarding the extension of the lesion into the distal segment of the popliteal, which was more frequently seen in the DEB cohort. Results indicated that binary restenosis for both the DEB and DES cohort were highly similar and that TLR rates were also highly comparable. Professor Zeller concluded by noting the weakness of this stage of the analysis, which occurred due to a drop in patient numbers in the drug-eluting balloon cohort, and he stressed the preliminary nature of these results and that work is ongoing. Slightly removed from the concept of leaving nothing behind, Dierk Scheinert concluded the featured research by presenting 30-day data from the ESPRIT study, asking whether avoiding a permanent implant is a viable concept for future treatments. The study investigates the Esprit-BVS, a drug-eluting, bioresorbable vascular scaffold developed by Abbot Vascular (North Chicago, Illinois, USA). Figure 6 ESPRIT-1 is a multicenter study, enrolling a total of 35 patients in seven sites, looking at single de novo lesions, limited to 50mm (with mean lesion length 35mm) in the SFA or iliac arteries in patients with symptomatic claudication at one, six and 12 months, and up to three years. The trial objective was to evaluate the safety and performance of the Esprit-BVS. With a relatively low rate of diabetic patients (25%), the majority of devices were implanted into the SFA, with 11% also into the external iliac artery. Most were implanted into the distal and mid third of the SFA. Acute angiographic results indicated in-segment diameter stenosis reduced from 80% prior to implantation to 13.1% after the procedure, suggesting that this device achieved a relatively good opening and scaffolding of the vessel (see Figure 5). Encouragingly, early results indicated no adverse events. In terms of clinical effects, 57% of patients were in Rutherford class 3, 34.3% in class 2, and 8.6% in class 1 before the procedure. Following the procedure, the majority of patients were asymptomatic (85%) or significantly improved (12% in Rutherford class 1) (see Figure 6). References 1. Nienaber CA, Rousseau H, Eggebrecht H, et al. Randomized comparison of strategies for type B aortic dissection: the INvestigation of STEnt Grafts in Aortic Dissection (INSTEAD) trial. Circulation 2009;120: Brott TG, Hobson RWn, Howard G, et al. Stenting versus endarterectomy for treatment of carotid-artery stenosis. N Engl J Med 2010;363: Bonati LH, Jongen LM, Haller S, et al. New ischaemic brain lesions on MRI after stenting or endarterectomy for symptomatic carotid stenosis: a substudy of the International Carotid Stenting Study (ICSS). Lancet Neurol 2010;9: Catheter-based renal sympathetic denervation for resistant hypertension: durability of blood pressure reduction out to 24 months. Hypertension 2011;57: Esler MD, Krum H, Sobotka PA, et al. Renal sympathetic denervation in patients with treatment-resistant hypertension (The Symplicity HTN-2 Trial): a randomised controlled trial. Lancet 2010;376: In-segment diameter stenosis in ESPRIT-1 reduced from 80% [to] 13.1% post-procedure Dierk Scheinert (Leipzig, Germany)

13 Collaborations at LINC: VIVA Bringing together experts from the world over to share their experiences, challenges and insights is an integral part of the LINC programme. With large, renowned and multidisciplinary meetings taking place in other parts of the globe, these moments of collaboration serve as a reminder that, instead of running parallel with each other, the ability to intertwine and share our new advances, techniques or brave ideas in one open forum will help speed our journey to better interventional medicine. Perhaps the most prevalent in the programme this year was the Vascular Interventional Advances (VIVA) course. As one of the leading multidisciplinary endovascular meetings in the United States, the meeting, and its faculty, are synonymous with professional excellence in the field of vascular medicine. It was therefore a privilege for LINC to once again join forces with VIVA for a number of exciting sessions in this year s program. Exploring the lessons from real case experience The LINC: Strategies on the frontline sessions at this year s meeting were rich with intriguing and challenging lectures. During the session on carotid disasters, the presentation by Michael Jaff (Boston, USA) was no exception, with him choosing to look outside of the topics most people focus on to instead deliver a case that would examine complications arising after left carotid endarterectomy. It s a very interesting case of someone who had a completely normal operative procedure, and in the recovery room developed a stroke, said Dr Jaff. The immediate post-procedural complications are shown in Figure 1. What would you do now? Dr Jaff continued, postulating that a lot of the audience would be tempted to return and re-explore the vessel, thinking it may be completely occluded. However, he noted that, if one starts interfering too much and the direction chosen is not correct, a bad situation could become even worse. Other options he suggested included taking the patient immediately to the intervention suite for arteriogram; beginning intravenous heparin or bivalirudin treatment; adding Plavix to the current ASA dose, or perhaps choosing another treatment altogether. Revealing his strategy, Dr Jaff Figure 1: Strategies on the frontline: Immediate post-operative status Awoke from anesthesia No neurologic deficits Fluent speech Visual acuity unchanged from pre-op Complained of dull, left-sided headache 45 minutes into post-operative stay Sudden dense right-arm hemiplegia No other motor sensory deficits Immediate duplex ultrasound Patent left CEA site No thrombus chose IV heparin and admittance to the neurological ICU for frequent neurological checks. With this in place, by day three postoperatively, there was complete resolution of weakness in the right arm. By seven weeks, right upper extremity motor strength was fully intact, albeit with some slight reduction in handwriting clarity (compared to pre-operative status) especially when fatigued. New technologies for long-established problems A core session in the LINC programme was dedicated to new technology in the field of complex limb revascularisation, with a focus on new chronic total occlusion (CTO) devices and managing instent restenosis, as well as looking to the future in atherectomy. As both moderator and presenter during the session, VIVA Co-Director Peter Schneider (Honolulu, Hawaii, USA) underlined why atherectomy is a core component. There are a lot of strong proponents of atherectomy in the US and yet the use of it is highly variable, he said. Some areas, geographically and within certain specialities, really believe in it, and others aren t so sure, so this remains a strong area of controversy. We also don t know if the acceptance of atherectomy will change a little bit now that we have the potential to use drugcoated balloons in patients who ve had those types of procedures. There s a lot to work out with that because there are going to be extra costs. Dr Schneider added that a second aspect of complex limb revascularisation that everyone struggles with is in-stent restenosis, hence the new technologies session was to feature a presentation that hopes to offer some insight into the many ways we can solve this issue, as well as describing specific hands-on experiences that have proven effective. Moving on to discuss new CTO devices that are changing the face of occlusion treatment and management, Dr Schneider said. There are some CTO devices that have been out there for a little while, and I think the new batch of CTO devices will complement that group, he said. With specialised rotating heads or other novel technologies, these CTO devices allow the operator to cross an occlusion that would otherwise be difficult with standard techniques. One of the reasons why this is important to me is because I m a vascular surgeon, and typically for years in vascular surgery, going back for some time, the belief was that if there was a long occlusion, then that was a Continued on page 64 The new re-entry devices have really complemented what we can do and what we can offer for a long occlusion. Peter Schneider (Honolulu, USA) 13

14 What happens after DEB vessel transfer? The turn of the millennium saw drug-eluting balloons (DEB) tentatively taking off, and comparative data regarding their efficacy have continued to emerge since then. In a symposium dedicated to IN.PACT DEB technologies (Medtronic, Fridley, Minnesota, USA), Robert Melder (Santa Rosa, USA) presented preclinical findings from the IN.PACT DEB performance study in peripheral vessels, addressing safety concerns about possible distal action of the balloon drug after insertion. Introducing and chairing the symposium was Erich Minar (Vienna, Austria), who was joined by moderators Marianne Brodmann (Graz, Austria), Peter Schneider (Honolulu, Hawaii, USA) and Thomas Zeller (Bad Krozingen, Germany). The attraction of DEBs is manifold: providing anti-proliferative therapy whilst leaving nothing behind, they also have a broad anatomical applicability; they avoid stent fracture and resultant problems; and they preserve future therapeutic options and patients quality of life expectations. The four elements of the IN.PACT DEB the platform, the drug, the excipient, and the coating technology are brought together for four Paclitaxel in arterial tissue (ng/mg) Time (days) different DEBs: the IN.PACT Falcon for coronary use, and the IN.PACT Admiral, Pacific and Amphirion for peripheral use. Describing the mechanism of drug delivery, Dr Melder noted the proprietary FreePac hydrophilic coating, which is a combination of urea and paclitaxel. The urea acts as an excipient, delivering the drug to the artery, as well as the diffusing the drug into the arterial tissue. Mechanical transfer of the drug from the surface of the balloon onto the arterial wall occurs simply by the apposition of these two surfaces. Beyond this, questions of where the drug travels and how it is distributed and cleared have as yet remained unanswered, but have formed the basis of the IN.PACT Admiral PK study in porcine ileofemoral arteries. The IN.PACT Admiral PK study design involved 5mm and 6mm by 80mm balloons, explained Dr Melder, and comprised two cohorts: a nominal dose group, with a single balloon treatment in both the right and left ileofemoral arteries, and a safety dose group, with three consecutive balloons administered again to both the right and left ileofemoral arteries. Samples of plasma, arterial tissue, and nontargeted tissues were obtained immediately post-treatment at various time points up to 320 days. The nominal therapeutic input dose was around 240 μg/kg and the safety dose was about 650 μg/kg. Mass normalised dosage was consistent across all study time points, and the dose range was substantially less than that which occurs in common use for tumour therapy. Beginning with plasma PK analysis results, Dr Melder showed that the safety margin dose created a maximum concentration (Cmax) in plasma of 3.9ng/ml, and that for All non-target tissue Cmax values are less than 2ng/mg for the safety margin dose and 1.2ng/mg for the therapeutic dose the nomimal dosecmax was about 1.6ng/ml. In both cases, bothcmax and duration of exposure was dose-proportional, and decay was rapid with a biphasic characteristic response. Drug duration in tissue matrix was divided into long ( day), intermediate ( day) and short (2 28 day) exposure. Arterial tissue had the highestcmax, ranging from 66ng/ mg at the initial time point for the safety margin dose and 35ng/mg initially for the nominal dose. In each case, the drug was present 0 30 Figure 1: Non-target tissue drug concentrations are consistently lower than in arteries in tissue for up to 120 days, finally clearing at 320 days. Non-target tissue drug concentrations were consistently and significantly lower than in arteries, said Dr Melder, showing that all non-targetcmax values were less than 2ng/mg for the safety margin dose and 1.2ng/mg for the therapeutic dose (see Figure 1). Intermediate duration PK was represented by distal muscle and pulmonary tissue charts, whose PK profiles were very similar to those Continued on page Systemic drug in plasma post-deb treatment is brief and at relatively low concentrations Robert Melder (Santa Rosa, USA)

15 Amphirion Balloons Move the Treatment of BTK PAD Forward Just several months after its initial availability, physicians around the globe are increasingly relying on a percutaneous transluminal angioplasty (PTA) technology for the treatment of below the knee (BTK) lesions: the Amphirion Plus PTA Balloon Catheter from Medtronic. With an over-the-wire diameter of inches and high pushability and crossability characteristics, the Amphirion Plus has been rapidly adopted among physicians worldwide for its ability to access and treat some of the most challenging and calcified BTK arteries. Distinguishing features of the Amphirion Plus include the device s wide inflation pressure range, which reaches 20 atmospheres (rated burst pressure) for all sizes from 2.0mm to 4.0mm in diameter and through 120mm in length. In addition to the versatile working range and size offering, the device s fast inflationdeflation provides an efficient angioplasty solution. With these benefits, the catheter has continued to justify its workhorse designation when addressing above the ankle procedures and the management of critical limb ischemia (CLI). The Amphirion Plus PTA Catheter expands Medtronic s product portfolio of medical devices used to treat peripheral artery disease (PAD) and is an example of the company s focus on developing innovative lesion-specific solutions for PAD. It joins the Amphirion Deep PTA Balloon Catheter, which targets lesions below the ankle. The versatile size offering of Amphirion Deep, along with its high flexibility and conformability with tapered features, provides significant benefit to physicians performing procedures in these tortuous and smaller blood vessels. Together, the Amphirion Plus and Amphirion Deep PTA Balloon Catheters an industry-first offering of providing both below and above the ankle treatment solutions for PAD represent a comprehensive solution for BTK interventions and are moving the treatment of PAD forward, one step at a time.

16 What happens after DEB vessel transfer? Pass 0 1st 2nd Target artery segment Distal muscle Circulating drug load initially encounters the distal muscle and pulmonary vascular network (1st pass) and later, kidney, liver, spleen and other tissues (2nd pass). Pulmonary Kidney Liver Spleen Continued from page 14 of the distal muscle, showing a safety dosecmax of about 1.6ng/ mg and a nominal dosecmax of about 0.5ng/mg. Drug clearance occurred between 90 days and 120 days in these cases. Pulmonary PK was in the same concentration range and showed complete clearance at both doses at 180 days. Dr Melder illustrated the nontarget, short duration PK analysis using liver and spleen drug measurements. In both cases, he noted, drug concentrations were very similar, with about 0.09ng/ mg in the safety margin dose for liver and about 0.01ng/mg with the therapeutic dose. The duration of drug in tissue was quite short, limited by the amount of drug administered, with clearance by seven to 28 days. Similarly, renal PK displayed very low concentrations, the highest being 0.138ng/mg for the safety dose and clearing in 28 days. Tying these results together from a global perspective, Dr Melder summarised that the concentration occurring in non-target tissues correlated roughly with the sequence of drug exposure (see Figure 2). Naturally, the highest concentration and longest duration is present in the treated artery segment, and the tissues that see the first run-off from this are the distal muscle and then the pulmonary tissue. Here, explained Dr Melder, intermediate duration PK with low concentration was observed. Finally, in the terminal phase, the kidneys, liver and spleen showed a very short duration PK with very low concentrations of drug. Moving on to systemic inplasma drug post DEB treatment, Dr Melder noted a brief incidence at relatively low concentrations. The highest initial concentrations were seen in arteries, although over the long term greater than 120 days relatively low concentrations were maintained, and these were cleared by 320 days. Although the systemic distribution of drug in tissues varied depending on location, the concentration was orders of magnitude less than that at the treatment site. No adverse effects were observed as a result of multi-compartment drug exposure. The presentation was concluded with a series of questions regarding safety and performance, beginning with Dr Minar, who asked about the optimal balloon pressure and duration of inflation that would ensure maximum drug transfer into the arterial wall. Dr Duration Long Intermediate Short Concentration High Low Very low Figure 2: Drug concentration in non-target tissue correlates with sequence of drug exposure Melder responded with results from his previous studies, which indicated that there seemed to be very little difference in the amount of drug transferred between one and three minutes of inflation. This suggested that even going down to 30 seconds would change the drug transfer very little, he said, because the mechanical effect and result remains more important than drug transfer. Stressing the importance of safety profiles in DEB studies, Dr Brodmann asked how DEBs might interact in patients with peripheral artery disease whilst undergoing cancer therapy. Could renal function, something that is often already compromised in cancer patients, be further exacerbated by DEB therapy? In response to this, Dr Melder agreed that a good safety profile is paramount in a clinical setting, and that this has been demonstrated. In addition, he continued, in this particular case with a difference of over a thousand-fold between what is delivered by balloon and tumour therapy, there is probably very little contribution by the DEB to renal problems. Peter Gaines (Sheffield, UK), who lectured during this session on the use of IN.PACT in the superficial femoral artery in claudicants, queried whether there were issues with overlapping drugs and whether more than one drug could be used in a single sitting, given existing knowledge about local and systemic drug concentrations. Dr Melder reiterated that, at most, six 80mm balloons were evaluated in his studies in small animals, yet no limit, theoretical or otherwise, had been set. As for their use concurrently with any other drug, he reasoned that, as the amount of circulating drug under these circumstances was pretty minuscule, he would be surprised to see any interaction. 16 A good safety profile is paramount in a clinical setting Robert Melder (Santa Rosa, USA)

17 Onyx liquid embolic system showcased at LINC Experts gathered during a dedicated session on Thursday at LINC to communicate the ease of use, controllability and efficacy of Onyx (Covidien, Mansfield, Massachusetts, USA), a non-adhesive liquid embolic agent that is showing great promise in a number of vascular applications. As chair of the session, Andrew Platts (London, UK) an expert in endovascular interventional radiology and also in interventional neuroradiology has had a lot of experience using Onyx, particularly in the treatment of intracranial vascular malformations, facial and peripheral vascular malformations, and also in endoleaks. He has also used it occasionally in other areas, including gastrointestinal haemorrhage. It s such a nice material to use because it propagates slowly, it propagates smoothly and if you ve got any concerns you can always stop and restart and that certainly isn t the case with glue, he said, before introducing the first speaker of the session, Hans Lindgren (Helsingborg, Sweden). Dr Lindgren introduced the new treatment possibilities that Onyx present, including endovascular aneurysm repair (EVAR), bleeding embolisation (aneurysms, type 1 or 2 endoleaks) and varicocele (prior to nephrectomi and angiomyolipoma). The first case he presented was a 70-year-old male who received a coil embolisation five years previously, who had now returned with bleeding and circulatory insufficiency. Figure 1 shows the anatomy of the patient, in which the previous coils are visible. As you can see, these coils are still preventing flow in his gastroduodenal artery, but there is another tiny aberrant artery from the splenic artery feeding this bleeding site, said Dr Lindgren. He added that, while approaching the bleeding site with the microcatheter proved difficult, there was a need to embolise both sides of the site. So now what to do? he said. In this case, I used Onyx, and not in the ordinary way (to form small droplets to control it), but more in the way of injecting contrast dye to get Onyx to follow the flow and be able to close both entries of that bleeding site. The patient became stable and could go home from the hospital a couple of days later. Moving on to discuss a varicocele case, Dr Lindgren described a young male with two previous coil embolisations who subsequently developed new symptoms after one month, thus he was scheduled for a third procedure. By injecting Onyx, his team were able to fill up the target area until a point a few centimetres from the renal vein, thus curing the patient simply and effectively. The next speaker in the session was Vincent Vidal (Marseille, France) who spoke of the use of Onyx in arteriovenous malformations (AVM). AVMS are pulsatile soft tissue masses, typically with associated bruit or murmur, said Dr Vidal. Present in early childhood, AVMs grow with the child, and may also undergo periods of more rapid growth such as during puberty, trauma, pregnancy or surgery. They are complicated by arterial steal in affected extremities, and venous congestion can lead to pain and bleeding. They can result in high-output cardiac failure, Dr Vidal underlined. Discussing the imaging of AVMs, Dr Vodel explained that using ultrasound AVMs appear as dilated arteries and veins, with MRI as flow voids (no mass), and using CT dilated vessels in the area of the lesion can be found. However, digital subtraction angiography (DSA) is able to identify the nidus, which he stressed was the most important aspect. Showing cases using Onyx, Dr Figure 1: Pre-procedural anatomy Vidal first described the case of a 29-year-old woman with a huge AVM in her uterus (Figure 2). The goal of the treatment is to eliminate the nidus, because the nidus is the stimulus for the recurrence via collateral recruitment, he said. The main problems, he added, were the complexity of the arterial supply in the AVM, identification of the site of shunting and the avoidance of proximal embolisation of the feeders with coils. Referring to the AVM of the case as typical, Dr Vidal outlined the usual characteristics: a tortuous artery, the nidus, and a large drainage vein. While the goal for Continued on page 18 [Onyx] is such a nice material to use because it propagates slowly, it propagates smoothly and if you ve got any concerns you can always stop and restart. Andrew Platts (London, UK) 17

18 Onyx liquid embolic system showcased at LINC Continued from page 17 treatment is to reach the nidus as close as possible with a microcatheter, he noted that the tortuosity makes this very difficult to actually reach the nidus. Dr Vidal discussed injection of the Onyx: You don t really see where it goes, because there is all this tortuous artery, but obviously it does not go in the nidus, it still refluxes in the tortuous artery, he said. Stressing the importance to persevere in this case for a further five minutes, he showed that the Onyx did then indeed reach the nidus through the tortuous artery. The final presentation came from Arne Schwindt (Münster, Germany), who discussed the use of Onyx in endoleaks. We know that 1% of all EVAR patients have an aneurysm growth due to endoleak, he began. If there s a persistent type 2 endoleak, there is a significantly elevated risk that the aneurysm will have a late rupture. So we can t say there is no problem with the endoleaks, and we have to go for treatment, and in a centre like ours where we do approximately EVARs per year, we see three of four patients with endoleaks that cause a problem. He added that possibilities for treatment include complete conversion, laparoscopic clipping of the inferior mesenteric artery or lumbar arteries, coil embolisations, or taking a trans-lumbar approach to glue and go endovascularly to the nidus. While conversion is always feasible, Dr Schwindt stressed, for older patients in particular surgical approaches are high-risk. Similarly, while laparoscopic clipping is very elegent, risks include bowel injury and vena cava injury. Coil embolisation is not suitable for multiple Figure 2: 29-year-old woman with an arteriovenous malformation feeding branches, thus only rare vessel systems can be treated with this technique. Furthermore, in high flow lesions, even multiple coils may not be enough. With the use of Onyx, Dr Schwindt and his team are able to build upon treatment strategies already in place to effectively combat aneurysms in a great number of cases. Referring to a specific example he said: Through the already lying coils, we could embolise the inferior mesenteric artery and we could embolise the feeding vessels of the lumbar arteries, and now this aneurysm is stable. For endoleaks, the team have a treatment strategy of detection, then three-month duplex and six-month CT follow-up. If there is no persistent endoleak at these stages, a one-year follow-up alternating between duplex and CT is used. If there is a persistent type 2 endoleak, they perform a variety of angiographic imaging techniques (including multi slice CT) to determine specific small flows into the aneurysm. If the aneurysm is not growing, we keep the conservative treatment, but if it grows more than 5mm we attempt trans-arterial embolisation first. If that is successful, we return to the normal follow-up plan, and if we are not successful we go as a second approach with a trans-lumbar puncture or increase the treatment surgically. With Onyx, Dr Schwindt and his team have treated seven patients with 19 type 2 endoleaks, the majority over the iliolumbar artery, a third in the superficial femoral artery and inferior mesenteric artery, and some rare cases in the superficial circumflexor. In the patients for which the nidus could be reached, over 90% were successfully treated with Onyx. Dr Schwindt offered a summary: The treatment of type 2 endoleaks with Onyx is feasible, as we could show today. Compared to glue, it is a controlled [method] of embolisation with small risk of trapping the catheter. Adding his thoughts as a conclusion, Dr Platts commented: We ve seen some very good demonstrations of how Onyx can perform, and all I can add is that it is a very effective agent, and it s easy to learn the skills, and I hope that you will find it useful in your practice. 18 We ve seen some very good demonstrations of how Onyx can perform... I hope that you will find it useful in your practice. Andrew Platts (London, UK)

19 Taking just one shot to treat renal denervation A novel irrigated radiofrequency balloon technology for the treatment of renal denervation took centre-stage on Friday afternoon, when a special session examined the clinical experience with the technology so far, and a live case transmission showed the novel device in action. After an introduction by LINC Course Director Dierk Scheinert (Leipzig, Germany), Britta Vogel (Heidelberg, Germany) took to the podium to give a presentation on the predictors of response in renal denervation. She began by noting that the Symplicity HTN-1 trial showed that renal denervation was associated with substantial reductions in both systolic and diastolic blood pressure (Figure 1). Furthermore, the response rate, where response was defined as an office systolic blood pressure reduction of 10mmHg, increased steadily from 69% at one-month follow-up to 100% at 36-month follow-up (Figure 2). Data from that study also showed that even non-responders at one month would achieve a 100% response rate at 36 months (Figure 3). However, when it came to looking for ways to predict response, hard answers were hard to come by. At 12-, 24- and 36-month follow-ups, it was impossible to delineate changes in systolic or diastolic blood pressure between Figure 1 patients divided by age, the presence of diabetes or renal function. After discussing other studies Figure 3 Figure 2 that failed to identify predictors of blood pressure lowering with renal denervation, Dr Vogel moved on to the Heidelberg registry, which is a real-word registry that includes 64 patients with treatment-resistant hypertension. This is defined as an office systolic blood pressure >160mmHg or >150mmHg in diabetics, and taking at least three hypertension medications or intolerance to multiple anti-hypertension medications. Of the patients, 17 presented with unfavourable renal anatomy, such as single kidney, fibromuscular dysplasia, previous stenting and accessory arteries. Blood pressure lowering at three, six, and 12 months postrenal denervation was significant for systolic blood pressure, and the response rate was 57%, 73% and 76% at three, six, and 12 months. When it came to identifying predictors of response, interestingly baseline blood pressure was significantly associated with change in systolic blood pressure at six months, with a baseline blood pressure of mmHg linked to an increase of 1mmHg in systolic blood pressure, baseline blood pressure of mmHg associated with a -21mmHg change in systolic blood pressure, and a baseline blood pressure of 180mmHg linked to a 36mmHg reduction in Continued on page 20 We are using [the OneShot balloon], first, because it is a single shot, so it makes the procedure more simple and more easy and, second, because it uses irrigation. Karl-Heinz Kuck (Hamburg, Germany) 19

20 Taking just one shot to treat renal denervation Continued from page 19 systolic blood pressure. However, Dr Vogel and colleagues found that there was no consistent support for an association between baseline characteristics such as age, diabetes or renal function at response to renal denervation. There was also no clear evidence that the number of ablation points or choice of device affected blood pressure response. She did note in closing that potential investigator-related effects, such as drop of impedance and temperature rise, are being studied in the GREAT Symplicity registry. OneShot in action live case transmission Next, the session switched to a live case transmission from St George Hospital in Hamburg, Germany, led by Karl-Heinz Kuck (Hamburg, Germany). Assisting, Dr van Wedel presented the case. He explained that it was a re-do case, which is certainly something that everybody is going to be running into during the course of renal denervation. He said that the patient was a 55-year-old male with resistant hypertension for over 10 years, and who had undergone renal denervation with a Symplicity catheter (Medtronic, Fridley, Minnesota, USA) in February He had a mean resistant systolic 24-hour blood pressure after the procedure of approximately 148mmHg, resulting in headaches and dyspnea on exertion. He had invasive ruleout of heart disease at the time of previous renal denervation. His medications were metoprolol 2 x 100mg, felodipin 2 x 5mg, candesartan 1 x 32mg, urapidil 90mg 1 x 1, and dihydralazin 2 x 12.5mg. Professor Kuck and colleagues decided to perform the re-do procedure with the Covidien (Mansfield, Massachusetts, USA) OneShot balloon. Dr van Wedel explained that they had right femoral access with 8 French catheter, and used heparin and an 8 French RDC guiding catheter (Cordis, East Bridgewater, New Jersey, USA), with an Asahi Sion blue guidewire (ASAHI INTECC, Nagoya, Japan). Professor Kuck said: We have done now a total of 30 patients as re-do cases, all cases who were non-responders of course. It s interesting that about 50% 60% of these people had improvements their blood pressure after the second procedure, indicating that potentially the single application with point point ablation in these patients cannot have been sufficient to get a good ablation of the vein. He continued: That s why we have taken this patient now to the lab again, and we are using the single shot Covidien device. We are using it, first, because it is a single shot, so it makes the procedure more simple and more easy and, second, because it uses irrigation. Returning to the case at hand, Professor Kuck explained: What we are doing now is we have introduced a guiding catheter via the right femoral artery to the left renal artery. We did discuss whether we should go with a balloon for the proximal part of the artery, which is around mm, or whether we should go also with the balloon and do two applications in each of these two big branches. We took the decision because the length before the bifurcation of the left renal artery, the mainstem, so to speak, is just a bit above 2cm, and the balloon size is exactly 2cm. We are therefore just a little bit afraid that we might not be able to position it perfectly. So we are now using a 6mm balloon in these mm branches. He added: As you probably know, this device comes in three sizes, 5, 6 and 7mm, the largest, the 7mm, has to go via 8 French, so since we didn t know which one we would use, at the end of the day, we have 8 French sheath inside. And we have a BMW wire that is introduced to the superior branch now. Looking at the live images on the screen, Professor Kuck said: I 20 One of the advantages of this system is that you have a potentially more reliable circumferential ablation due to the spiral shape of the electrode, as opposed to single point electrodes. Dierk Scheinert (Leipzig, Germany)

21 would like to make an injection now, and before we introduce the balloon, I would like to show you how the balloon works. I am sure you have seen the balloon probably during one of these presentations, but as you can see, this is the shaft, and at the distal end sits the balloon. There are 8 holes inside of the balloon that allow exiting of the saline from the balloon. This saline is used to cool the surface of the balloon during the radiofrequency application. This cooling is extremely important to protect the endothelium, or the inner surface of the artery, from the radiofrequency effect, which of course is heating the interface between the tissue and the surface of the balloon. So it is extremely important to use such a cooled system. He continued: In general, we of course prefer irrigated systems over non-irrigated systems because, with a non-irrigated system, we always take the risk of overheating the interface between the catheter tip and the tissue, which then may lead, of course, to some kind of charring/thrombus formation and potentially to rupture of the tissue. So I feel very comfortable and familiar using an irrigated balloon catheter. Professor Kuck added: Now, the interesting thing here is that the electrode band on the balloon has a spiral format and it expands over the 2cm [length]. While he advanced the balloon into the superior branch, he reiterated: It s an over-the-wire system. You see the two markers, very much like a PCI procedure, that mark the distal and proximal ends of the balloon, and inside the balloon is a temperature sensor. Focusing again on the procedure, Professor Kuck said: I now do an angiogram, and you can see there is a little atheroma at the beginning of the superior branch, as well as at the bifurcation at the inferior branch. We want to avoid applying radiofrequency current at the site of these plaques. We want to go a little more distal, and as you can see I have advanced the balloon a little bit to stay away from this plaque. You can see now that the superior branch is completely occluded, which is a pre-requisite if you want to use radiofrequency, and there is perfect wall contact. We are starting the application now As you can see from the console, it is a two-minute application, and we are delivering 25 watts constantly, and the impedance is in the range of 110 ohms. Most of this time, it is in this range, and the temperature Continued on page 25

22 Scrub in with the experts: complex cases, hybrid techni Delegates were welcomed to LINC 2013 s first Scrub in with the Experts session, on advanced techniques and hybrid approaches for complex aorto-iliac and femoropopliteal disease, by Chris Metzger (Kingsport, USA). He was joined by co-chair Ramon Varcoe (Sydney, Australia) and moderators Hans Krankenberg (Hamburg, Germany), Jean-Paul de Vries (Nieuwegein, Netherlands) and Thomas Rand (Vienna, Austria). Against the backdrop of a challenging live procedure broadcast live from Park Krankenhaus (Leipzig), three short talks addressed optimal methods, hybrid techniques and complications in aorto-iliac femoropopliteal interventions. Dierk Scheinert (Leipzig, Germany) joined Sven Braunlich (Leipzig, Germany) and Johannes Schuster (Leipzig, Germany) with the live case, a recanalisation procedure in a high-risk patient with occlusion of the aortic bifurcation and claudication in both legs. Explaining the case, Dr Schuster said: We have a 54 year old patient with well-known risk factors: arterial hypertension, current nicotine abuse and diabetes mellitus type II. We are in with a 6 French sheath from the left brachial artery and have punctured both femoral arteries, on the right side with an 8 French and on the left side with a 10 French sheath (because we are already prepared for the aortic stent). We want to pass the occlusion from the brachial, then snare the wire and do a retrograde PTA, then stenting. With the angiography on screen, Professor Scheinert outlined the bilateral sheath in the groin, the renal arteries, and the first segment of the aorta, which looked 22 A brachial approach gives a much better chance to develop the right push in the right direction Dierk Scheinert (Leipzig, Germany)

23 ques and practical advice favourable. The plaque and bilateral occlusion of the common iliac was visible. The occlusion did not appear to extend far into the aorta, although being heavily calcified it would potentially be challenging to cross. Summarizing the team s approach, Professor Scheinert said: I would necessarily try to start with a brachial approach, because I think it gives a much better chance to develop the right push in the right direction without dissecting too much in the area of the aortic bifurcation. So we will do that into one side, snare the wire, and then go to the other side. I m going to do that with a combination of a 5 French multipurpose catheter and a stiff angulated Term [Tokyo, Japan] wire. Having advanced the catheter in the right groin, Professor Scheinert removed the glide wire and inserted a Super Coil wire in its place, providing a stable axis for stent implantation. On the left side, a Judkins right catheter was selected because of the curvature of the aortic bifurcation on that side. Pre-dilatation was performed with one balloon from the brachial artery on the left side, and another from the groin on the left side, and subsequent angiography confirmed improved flow. With marker catheter in place, the aortic stent (22/60mm; Optimed sinus-xl) was placed into the tapered part of the infrarenal aorta from the right side, after which further stenting was continued into the common iliacs from the left side using non-covered stents (given the extent of the large lumbar arteries). Removing the wire from behind the aortic stent, the team then rewired the left iliac from the brachial excess to facilitate the kissing stent implantation. The reconstruction of the aortic bifurcation with two Omnilink Figure 1 stents (Abbott Vascular, North Chicago, Illinois, USA; 8/57mm) gave an overlap of 5 8mm between the kissing stent and the aortic stent. The team concluded by extending the stenting from the common iliac into the femoral arteries, where the occlusion terminated, using an Absolute nitinol stent (Abbot Vascular; 10/40mm) in the right iliac, and a longer extension in the left iliac (8/150mm). Figure 2 Optimum aortoiliac bifurcation reconstruction Moving onto the flash presentations, Dr Varcoe was first to the podium with a presentation on optimum techniques for the reconstruction of aorto-iliac bifurcations under a variety of scenarios. Historically, aorto-bifemoral and biiliac bypass have proved to be durable, but their morbidities prompted a paradigm shift towards endovascular approaches. Morbidity is considerably different, particularly in terms of sexual dysfunction, major morbidity and death, although there is little difference in patency. While TransAtlantic Society Consensus (TASC) A and B lesions are perhaps more quotidian for endovascular therapists, type C and D lesions reflect a greater uncertainty as to which procedure is likely to be more successful both in the short and long term (see Figures 1 and 2). Ultimately, their durability requires further evaluation as it is not yet clear whether endovascular techniques result in greater life span than open surgery. Addressing the case of disease around the bifurcation, Dr Varcoe observed that most people approach this ipsilaterally with bilateral common femoral artery punctures and wires, with kissing Continued on page 24 If the stent is lost advance a small balloon if it is on the wire and proceed with progressive dilatation. Parag Doshi (Elk Grove Village, USA) 23

24 Scrub in with the experts Continued from page 23 balloons for pre-dilating, and finally balloon-expandable stents for their additional radial force and accuracy of placement. He added that if the disease extends into the distal aorta, stenting can be extended proximally too. Moving on to the external iliac, Dr Varcoe noted that he generally approaches these ipsilaterally initially too, although they are very different vessels from the embryological perspective. However, as this does not always lead the operator to the correct region, he recommended an up and over approach using an appropriately angled catheter as a secondary option in order to snare the wire. An artery that possesses a higher risk of rupture demands a tentative approach, Dr Varcoe explained, particularly in a small artery with heavy calcification. Stressing the importance of treating such cases gently, he also said that it is advisable to have a covered stent ready during procedures, in order to avoid disasters when they have not been deployed initially. Hybrid techniques for complex aorto-iliac interventions Carlos Mena-Hurtado (New Haven, USA) continued along this theme with his presentation on hybrid techniques for complex aorto-iliac interventions, highlighting an approach that has brought endovascular specialists and surgeons together in a way to help patients that otherwise would be faced with long-term complications and amputation. Dr Mena-Hurtado cited multiocclusive disease, usually including the common femoral artery either with concomitant inflow or outflow disease that may demand bypass, as particularly benefiting from the hybrid approach. Complex and simple hybrid procedures enable multi-vessel revascularisation, he said, particularly in high risk patients, and give a favourable patency rate, low degree of complication, and limb salvage. Lower extremity revascularizations centre about the common femoral artery, and it is well appreciated that endarterectomy does not have a decent endovascular counterpart in this region. Whilst it is offered to patients, dealing with concomitant inflow and outflow disease must also be performed if the patient is to recover from conditions such as critical limb ischemia. While the surgeon paves the way by endarterectomy of the common femoral artery, Dr Mena- Hurtado said, the inflow and outflow procedure can be performed concomitantly by the endovascular approach. Speaking of the benefits of such treatments, Dr Mena-Hurtado cited shorter lengths of stay and shorter procedure and recover times. This is significant for high risk patients, even though the hybrid method offers no improvement in mortality. Mortality, however, is also driven by comorbidities, and hybrid techniques offer an option to those patients with comorbidities excluding them from eligibility for surgery. Importantly, patency data for TASC A and B as well as C and D lesions indicate comparability between open and hybrid procedures. Managing complications in complex aorto-iliac procedures Next, Parag Doshi (Elk Grove Village, USA) shared some tactics for managing the complications that occur in complex aorto-iliac procedures, including embolisation, plaque shift (especially common in the aorto-iliac disease near the osteum), losing the stent off the balloon, dissection and arterial rupture. Avoiding plaque shift and embolisation Dr Doshi recommended predilation with an undersized balloon, because in a bulky lesion a covered stent can be used (or at least a stent that offers generous lesion coverage). In his experience, after the use of an undersized balloon and during stent placement, occlusive pressure held on the groin near the sheath results in what he referred to as a poor man s Mo.Ma device. After deploying the stent, vigorously aspiration facilitates the removal of debris. How not to lose the stent Dr Doshi advised avoiding the cross-over sheath in balloonexpandable stents in calcified lesions in order to avoid complications. Instead, he recommended to use a second, long sheath with radio-opaque tip and to consider uncovering the stent. If the stent is lost, he suggested, to advance a small balloon if it is on the wire and proceed with progressive dilatation. If the stent and wire are lost Snaring can be traumatic in calcified vessels. Dr Doshi suggested the use of a low-profile snare to snare at the ends of the stent (not in the middle to avoid bending). If the vessel is very poor, he prescribed the deployment of an additional stent prior to retrieval. Dissection Dr Doshi explained that his practice often involves iliac and CFO dissections. Considering alternating approaches, he suggested an auxilliary, brachial or even popliteal approach to find the direction of dissection. In aortic dissection, he noted that it is fairly common, during recannalization of the iliac CTOs, to advance from the groin, and advised agains the use of excess retrograde injections. Vessel rupture Concluding with a warning about the sometimes misleading consequences of this event, Dr Doshi described the two-phase response that follows vessel rupture, which occurs more commonly in calcified vessels and with large devices (12 and 16 French). First, there is a vagal response: a sudden drop off blood pressure is observed, with hypotension and low pulse out of proportion to the blood loss. Second, the vagal response improves, although the patient will be gradually deteriorating if the bleeding continues, and Dr Doshi advised persistence in searching for the locality of the leakage. 24 Hybrid techniques offer an option to those patients with comorbidities excluding them from eligibility for surgery Carlos Mena-Hurtado (CT, USA)

25 Taking just one shot to treat renal denervation Continued from page 21 is 36º. Now, that temperature only indicates to you that we are really cooling the surface of the balloon, otherwise it would go up to 50º, or maybe even 55º. This is the temperature that is measured by the sensor inside of the balloon, so it s not reflecting the real interface temperature. Professor Scheinert asked at this point: The impedance with system is around 100 ohms, while, with the single electrode systems, we are used to seeing higher impedance values I am sure you have an explanation why that is different with these systems? Professor Kuck replied: We are measuring here, of course, the overall impedance, and as I mentioned before, this is a spiral electrode-like band. The usual tip electrode is much smaller, so that the impedance is higher with a smaller electrode, as we all know. This indicates to you that the impedance measurement [with the OneShot balloon] comes from a larger surface area, as compared to what we usually measure if we are using the Medtronic point point ablation device. Professor Scheinert had another point to raise, saying: You mentioned that you have done 30 re-do procedures so far. One of the advantages of this system is that you have a potentially more reliable circumferential ablation due to the spiral shape of the electrode, as opposed to single point electrodes. What we were discussing here in the previous talk was predictors of response and to discuss whether the number of ablation points, or also the presence of unfavourable anatomy would have an effect if you go for single point ablation. So I am wondering, out of these 30 patients, have you seen anything like such a correlation that patients with fewer, let s say, ablation points, or less optimal anatomy were amongst those non-responders. Professor Kuck commented: Actually, based on the experience that we have, and the largest experience, of course, is using this point point ablator, we have changed the number of applications. We usually try to deliver as many as possible, which on average is something like 6 7 applications per renal site, because our experience was that we clearly saw a better response when we had more applications than with fewer applications. I personally do believe that, using this point point ablation device, that we may achieve better results by more applications. He added: Whether that is also true for this type of device, I don t know. From all the work that has been shown, the initial studies were all done with a single application per artery, and it looks like the results are quite encouraging. On average there is a decrease in systolic blood pressure of 40mmHg, and in the diastolic of around 20mmHg. Going back to the procedure, Professor Kuck said: We are reintroducing the balloon into the inferior branch and repeating the procedure as in the superior branch with a two-minute application. Performing another angiogram, he said: As you can see, despite the fact that this vessel was quite taut, we see neither a spasm nor any dissection, nor anything else. It looks very clean, it looks very much like it looked before. They continued the procedure, and debated a series of points that have arisen since the introduction of renal denervation, before bringing the live case transmission successfully to a close. As you can see, despite the fact that this vessel was quite taut, we see neither a spasm nor any dissection, nor anything else. It looks very clean, it looks very much like it looked before. Karl-Heinz Kuck (Hamburg, Germany) 25

26 From the vanguard to clinical routine in revascularisatio Peripheral vascular disease represents a growing clinical burden brought about by factors such as increasing rates of diabetes mellitus and hypertension, and Wednesday s Global Expert Exchange Forum, chaired by Roberto Ferraresi (Milan, Italy) and Michael Edmonds (London, UK) focussed on the pressing global need to keep ahead of the crisis in these complex cases. Alongside a host of pan-global perspectives on management strategies, Marco Manzi (Abano Terme, Italy) and colleagues presented, live from Mercogliano, a case of below-the-knee (BTK) arterial lesion. The patient, a 47-year-old man, had multiple risk factors and undergone previous endovascular procedures. Angiography in this Rutherford class 4 case indicated a lesion in the tibial trunk and proximal peroneal artery. Dr Manzi began by explaining the team s approach to deal with the lesion that spanned the tibioperoneal trunk into the peroneal: We are on contralateral access, with a long sheath of 90cm. We try to cross the lesion with a inch wire. We will place another wire in to protect the posterior tibial artery that we consider very important (but it is not diseased). After, we will do a dilatation with a 3.0/80mm balloon and after that with a drug-eluting balloon (3.5/80mm.) We can check the final result with IVUS [intravascular ultrasound] to decide, in case of dissection, whether it is necessary or not to place a stent. The team placed a catheter into the popliteal artery, and by angiography noted the tight lesion present before the posterior tibial and peroneal bifurcation. The distal tibioperoneal trunk also indicated some involvement. The posterior tibial showed minimal plaque and in the peroneal moderate plaque. The team proceeded to position two BMW coronary wires (Abbott Vascular, Abbott Park, Illinois, USA) in the posterior tibial and peroneal arteries. They expanded the undersized balloon (inflating for three minutes under 8 Atm), being careful not to over-inflate. Even so, a dissection made itself known in the distal popliteal. Angiography indicated good flow, although judgement was difficult in the presence of the wires, and IVUS was used to verify whether or not stenting was necessary. Indeed, IVUS revealed a much grimmer picture. The Eagle Eye catheter (Volcano Europe, Brussels, Belgium), indicated two dissections a highly stenosed section of the tibioperoneal trunk, and a 50% stenosed peroneal artery. Hence, the team opted for stent implantation in the tibioperoneal trunk, while leaving the smaller lesion untreated to avoid compromising the posterior tibial. The team performed balloon angioplasty (12 atm) in the proximal tibioperoneal trunk. A 3.0/20mm bare metal stent was then implanted before the bifurcation with the distal tibial artery. The team concluded with IVUS to assess the integrity of the posterior tibial. Although a small dissection was present, it was not deemed to be obstructive. The removal of wires indicated fast flow in treated and surrounding vessels. The patient, having presented initially with significant rest pain, would hopefully be greatly relieved by the procedures performed during this case. To dare, or to stop? Immediately after the live case, Dr Manzi spoke more generally about BTK patients, stressing that a combination of factors should dictate whether or not one can justifiably dare to pursue aggressive treatment. While most would agree that an over-simplification of patient classification is not sufficient to outline a treatment strategy that is tailored to a specific patient, there are, of course, commonalities that many BTK patients share. It is true that most patients are diabetics presenting with lesions, but lesion severity and concomitant risk factors dictate the downstream risk of amputation and patient destiny in the longer term. Dr Manzi cited a relatively low risk of amputation of 25% in patients in the lower classes of the University of Texas Diabetic Wound Classification. He advised that, in the absence of negative predicting factors, one must dare to recannalise BTK vessels in order to improve foot blood flow in these patients. The situation is different in worse patients, he said. We must always try to improve the flow in the distality. From clinical research literature, Dr Manzi surmised that negative predicting factors are related to outcome, not to the acute success of procedures. One Japanese group identified various negative predicting factors for outcome, including the presence of a target vessel diameter below 3mm, calcified lesion, and lesion length of more than 30cm with an absence of below-the-ankle run-off. The group of Lepäntalo (Helsinki, Finland) came up with a different analysis, with the presence of cardiac morbidity, the inability to walk upon arrival at hospital, and gangrene at first clinical presentation forming negative predicting factors for outcome. In our experience, we think that we should define negative predicting factors for the acute success of the procedure, said Dr Manzi. He used the example of a patient presenting with a small, Texas University class 1C lesion, noting that they should be treated with negative predicting factors in mind. These factors include severe obesity and dialysis. During a procedure, an early rupture that needs embolisation is also a negative predicting factor. In addition, severe diffuse calcification with an angled anatomy of the artery, arterial thrombus formation at the beginning of a procedure, or indeed a procedure that is drawn out over 90 minutes in the presence of pain in the patient, can have a negative influence on acute success too. Such tricky circumstances are often helped with a breath of fresh air and Dr Manzi suggested that rescheduling the patient for a different procedure may be the best option when difficulties 26 In our experience, we think that we should define negative predicting factors for the acute success of the procedure. Marco Manzi (Abano Terme, Italy)

27 n present. He stressed that, for less severe lesions, the easiest, safest and fastest procedures are best for the patient. Less aggressive wires, fewer crossing attempts, and the full respect of collaterals in the distality are all good measures to adopt for procedural success and a better outcome for the patient. The Singapore story Singapore is a small South Asian country with multiple ethnicities, and its cases of peripheral artery disease (PAD) often present with significant comorbidities. Jackie P Ho, (Singapore) presented data revealing the patient landscape in this region, highlighting cases that are typical in terms of approach, patency and clinical outcome. The number of patients with critical limb ischemia (CLI) that Dr Ho has treated has increased significantly over the past three years. Chronic total occlusion (CTO) patients represent some of the most difficult patients to treat. Reviewing the cases of PAD with CLI or severe claudication and CTO lesion over the last three years, Dr Ho found that 83% of patients were diabetic. A third suffered end-stage renal failure, and another 10% had poor renal function. 84% of patients presented with CLI with varying degree of tissue loss, and 2% presented with rest pain. It is good to know that the more you treat, actually the higher the chance is of successful treatment of the CTO, Dr Ho noted. She lauded the increasing improvements and availability of advanced technologies, including wires, support catheters, sheaths, and balloons in improving outcomes. Recent additions to interventional facilities, a hybrid suite and imaging system for peripheral interventions, have also improved performance. Technique itself has also continued to evolve, and swiftly taking these new concepts on-board is critical for ensuring the best results for patients. A retrograde pedal approach has become part of Dr Ho s battery for dealing with complex BTK cases, as has a more subintimal approach for iliac and superior Roberto Ferraresi femoral artery (SFA) disease. The outcomes of the study were optimistic, with an amputation salvage rate of all patients at one year follow-up of 83%, compared with 85% in those with successfully treated CTO segment. Dr Ho explained that this was probably because the stenosed segment was opened up as well as the CTO, which might improve the circulation. She also said that, in those patients with extensive tissue loss, amputation is inevitable. However, in the twoyear follow-up, a more favourable trend emerged in limb salvage in patients that had their CTO segment opened. In terms of survival rates, there was no great difference over the course of one year, but survival rates were higher in those that had their CTO segment treated. A similar trend occurs in amputation rates. However, early reocclusion of the revascularised CTO segment did happen at a rate of approximately 6.3%. There was no difference in the incidence of reocclusion in different levels of the arterial system. The Asian population with PAD and CLI and CTO lesions of the lower limbs are medically frail, Dr Ho said. Although their life expectancy is poor, successful CTO treatment is associated with better survival rates. This is perhaps on account of limb salvage, which equates to better mobility, and decreased pain. Renal patients, with their highly calcified CTO lesions, are also the most depressed. In these cases, Dr Ho advocates an aggressive, early revascularisation approach, with aggressive wound care that may involve early amputation to avoid the later spreading of infection. It is good to know that the more you treat, actually the higher the chance is of successful treatment of the CTO Jackie P Ho (Singapore) 27

28 A better future with rotational thrombectomy A session that explored the benefits and improved treatment outcomes of mechanical debulking in occlusive disease was held on Friday at LINC, with a number of presentations and live cases tasked with elucidating more on the indications and user-experience of this emerging technology. Michael Lichtenberg (Arnsberg, Germany) discussed the latest indications and results for the use of mechanical thrombectomy in a number of different settings. During the last years, we saw a clear difference in the treatment approach for patients with acute venous or arterial occlusions, he said. Today, I want to talk about the present study situation and show you some case reports from our clinic in which we used the rotational thrombectomy devices Rotarex and Aspirex [Straub Medical, Wangs, Switzerland] in different indications. Dr Lichtenberg listed thrombotic arterial occlusion, in-stent restenosis debulking and atherectomy (a fairly recent indication) and the upcoming indication of deep vein thrombosis (DVT). Looking to the literature, we can clearly see that the old established therapy local lysis therapy in acute thrombus is inferior to rotational thrombectomy, continued Dr Lichtenberg. Specifically, studies such as Zeller et al 1 and Wissgott et al 2 demonstrate that there is a clear benefit in endpoints such as freedom from amputation (12 months) and re-intervention when using rotational thrombectomy. Dr Lichtenberg introduced the Fempop study, a monocentric, prospective registry of 22 patients who presented with acute/subacute femoropopliteal bypass occlusions, in which the efficacy of the Rotarex rotational thrombectomy device was examined. The study was undertaken between June 2009 and June 2011, with a subsequent 12-month follow-up. The demographics/risk factors and lesion description/endovascular data for the study cohort are displayed in Tables 1 and 2, respectively. At 12-month follow-up, the results were very promising. All but one of the patients were treated Table 1: Demographics and risk factors Patients 22 Age (years) 70.2 ± 15.3 Male 12 Female 10 Smoker 15 Dyslipidemia 18 Diabetes 10 Hypertension 16 Klinikum Arnsberg. Stage I ischemia: 8. Stage IIa ischemia: 12. Stage IIb ischemia: 2 successfully with the Rotarex device. Walking capacity and ankle brachial index were significantly improved at 12 months. Dr Lichtenberg continued, describing the next indication for rotational thrombectomy: aortic stent graft embolic occlusion. He showed before and after images of a thrombotically occluded side branch of an aortic stent graft. Utilising a transfemoral approach, an 8 French Rotarex device was able to re-open the occluded segment. Weighing up the indication for rotational thrombectomy in proximal DVT, Dr Lichtenberg began by stressing that, as we all know, DVT is associated with a high morbidity, and a high economic cost. The guidelines still tell us to treat these patient conservatively, but we have encouraging interventional data so far with IIa/b recommendations to prevent, especially, the post thrombotic syndrome as a marker of quality of life, he said. Giving an example of a typical DVT case from his centre, Dr Lichtenberg exhibited a 61-yearold female patient with diabetes mellitus, adipositas and phlegmasic cerulean dolens on her right leg, with painful leg swelling persisting for four days. The patient was determined to have acute thrombosis of her left iliac veins. We treated this patient in the prone position, and ultrasound guided we went in with a 6 French access and then performed an Aspirex aspiration and managed to reopen the proximal part of the femoral vein and also the iliac veins with a nice functional results afterwards, said Dr Lichtenberg. And what is so impressive with these patients after treatment is that they really improve within hours, and show very a good clinical situation. Table 2: Lesion description and endovascular data Length of occlusion in bypass 28±10cm Venous bypass 12 Artificial bypass (PTFE) 10 P1 Segment bypass 22 Age of bypass months Rotarex 8F 15/22 Average Rotarex runs 3.8/patient Technical success (no local lysis) 18/22 Klinikum Arnsberg A final indication that Dr Lichtenberg commented on was the upcoming notion of using rotational thrombectomy in visceral arteries/acute occlusions. This seems to also be a very promising indication for using the Rotarex device, he said. He concluded: The Rotarex and Aspirex devices are an effective approach to treat patients with acute arterial and venous thrombosis. The real advantage of this approach is that we do not have systemic complications if you compare this to local lysis therapy or even to the surgical approach. This means that these patients stay an average in our hospital of only four days and we gain a lot of experience with subacute occlusions, so this is also an option for treatment. But we definitely need multicentre randomised studies for direct comparison of thrombectomy and local lysis therapy in DVT. References 1) Zeller T et al., Langzeitergebnisse nach Rekanalisation akuter und subakuter thrombotischer arterieller Verschlüsse der unteren Extremitäten mit einem. Rotations- Thrombektomiekatheter. Fortschr Röntgenstr 2002: 174: ) Wissgott C et al. Behandlung akuter Okklusionen von femoropoplitealen Bypässen: Vergleich der mechanischen Rotationsthrombektomie mit der ultraschallgestützten Lyse. Fortschr Röntgenstr 2008; 180: Looking to the literature, we can clearly see that the old established therapy local lysis therapy in acute thrombus is inferior to rotational thrombectomy. Michael Lichtenberg (Arnsberg, Germany)

29 Gentle debulking of arterial and venous occlusions with a dedicated mechanical device Recent publications about the treatment of vascular occlusions clearly emphasize strategies to reduce or to entirely avoid additional inflammation and biological reaction in those segments of the target vessel, which had not been damaged prior to the intervention. The scaffolding of both the SFA and the popliteal artery by the use of long stents is subject of controversial debate. With the Rotarex S and Aspirex S catheter families, Straub Medical is offering a valid solution for the gentle treatment of occluded vessels. In May 2011, both catheter families received CE-marking as Class III devices according to EU- MDD and can now be used in all vessels of the circulatory system except the coronaries, the brain and the cardiopulmonary system. Straub Medical`s Endovascular System has a track record of a decade of safety and efficacy. Deciding on treatment strategy Vessel occlusions are commonly classified as acute, subacute or chronic. This definition is mostly based on one symptom, the onset of pain. To the interventionist, deciding on the ideal treatment strategy, this classification is of no help. In most cases the lesion consists of heterogenic occlusion material of different age. The underlying stenosis might be as varying in composition as the occluding embolus or thrombus and the appositional thrombus that has formed as a result of the occlusion. The key to optimal treatment is to avoid inflammation, biological reaction and vessel wall damage in those segments of the target vessel, which had not been diseased or traumatized before the intervention took place. Unmasking the culprit The ideal device for the treatment of all occlusions would remove the thrombus entirely, regardless of its age, consistency, volume or length, and thus unmask the culprit stenosis, without compromising the vessel wall integrity. In many lesions, the removal of all detachable material will allow for a focused treatment of the underlying stenosis, especially offering the option of effectively using DEBs or interwoven stents. Safe and effective Rotarex S catheters remove occlusive material from any type of occlusive lesion without harming vessel wall integrity. Any material detached by the working tip is securely aspirated into the side openings of the catheter head and then removed from the vessel into a collecting bag outside the body. Version approved for acute thrombotic and thromboembolic occlusions in veins Catheters of the Aspirex S family perform continuous aspiration and fragmentation of less organized clot. They feature a non-rotating, entirely smooth and rounded tip. Catheters of this type are indicated for use in acute thrombotic or thromboembolic occlu-sions, where the fast and reliable removal of fresh thrombus is intended. Approved for veins, the Aspirex S catheters are indicated for the treatment of acute venous occlusions except PE. Limitations The use is limited by target vessel diameter and the need for prior intraluminal guide wire passage across the entire lesion. Clinical data, list of publications and reports available at: Straub, Rotarex and Aspirex are registered trademarks of Straub Medical AG.

30 The Great Debate: Should we aim to leave nothing beh One of the main threads of LINC 2013 was given a dedicated, in-depth session at Thursday lunchtime, when leading experts from around the world discussed the concept of leaving nothing behind as a potential new paradigm for peripheral intervention. The session began with a comparison of the impact of metallic implants and the use of drugs in peripheral interventions by Renu Virmani (Gaithersburg, USA), which was followed by a review of clinical trial results with nitinol stents and drug-eluting stents by Erich Minar (Vienna, Austria). Professor Minar examined data from a number of studies, 1 6 as well as conference proceedings and European Society of Cardiology Guidelines, 7 finding that nitinol stents increase primary patency over percutaneous transluminal angioplasty (PTA) alone, with an indication for primary stenting in TransAtlantic Society Consensus (TASC) II type B/C/D lesions. However, Professor Minar did note that the randomized data is limited to TASC A and B lesions. He also observed that the new generation bare metal stents (BMS) have better patency outcomes than the first-generation nitinol stents and that, for the treatment of short lesions, the patency of currently available drug-eluting stents is comparable to that of the new generation BMS. He ended by saying: Drug-eluting stents seem to have superior patency for treatment of longer lesions. Next, LINC Course Director Giancarlo Biamino (Mercogliano, Italy) used insights from randomised controlled trials and real-world practice with a range of technologies to ask the question: How good are drug-eluting balloons (DEBs)? He began by examining data on first- and second-generation nitinol stents, and explained that the superficial femoral artery is a bad conduit for implants. The two primary reasons for this are: that stent fractures may occur, which may trigger restenosis and for which the long-term implications are unclear; and in-stent restenosis, which has a one-year incidence in the SFA of 18% 40% and a two-year recurrence of 49.9% in class I, 53.3% in class II, and 84.8% in class III lesions. Professor Biamino went on to state that the primary arguments for DEB in the periphery are that they: are an anti-proliferative therapy while leaving nothing behind; have broad anatomical applicability; avoid stent fracture and in-stent restenosis burden; preserve future options; and match patients quality of life expectancy. He continued by setting out the technologies that he would cover in his talk (see Figure 1), and discussing the impressive results that have been achieved so far (see Figure 2). To underline his point, he showed an example case of the outcomes that can be achieved with drugcoated balloons (see Figure 3). After noting excellent 12-month results with atherectomy plus DEB in high calcific SFA lesions, with primary patency of 90% and secondary patency of 100%, 8 Professor Biamino concluded that the PACCOCATH (Medrad, Warrendale, Pennsylvania, USA) and IN.PACT (Medtronic, Fridley, Minnesota, USA) platforms have proven to be safe and efficacious for the treatment of femoral-popliteal disease in claudicants with TASC A-B/C lesions. Furthermore, IN.PACT has demonstrated safety and efficacy in complex below-theknee/critical limb ischemia lesions. However, Professor Biamino said that no class effect for DEBs has been observed, before concluding: More clinically relevant, longer term data are needed beyond the proof of concept to validate the therapy value of each DEB technology. Figure 1 Figure 2 After two more presentations a meta-analysis of studies comparing 30 Drug-eluting stents seem to have superior patency for treatment of longer lesions. Erich Minar (Vienna, Austria)

31 ind? DEB, PTA and BMS and a discussion all that is currently not known Figure 3 Figure 4 about DEBs Thomas Zeller (Bad Krozingen, Germany) closed the session with a presentation on the cost-effectiveness of the concept of leaving nothing behind. He explained that, compared to initial intervention, the follow-up interventions are associated with: expensive non-balloon equipment; more time, more radiation and the use of more contrast; longer stented segments; and a possible cascade of interventions. Looking at data presented by Mark Burket (Toledo, USA) at LINC 2011, Professor Zeller said that the typical costs of re-intervention after an index procedure 11 months previously are 270% higher than at the index procedure for the equipment alone. Speaking before his presentation, he told LINC Review: So basically the goal must be to avoid re-interventions in general, and this opens the discussion for what is the right approach for even a simple lesion. Professor Zeller continued: You probably know that the results for simple balloon angioplasty in short lesions are not that bad, with patency rates in the range of 60% 65% for a short focal lesion with balloon angioplasty only. However, even if you consider this as a good result, taking into account these cost-effectiveness calculations of Burkett indicates to me that even a simple lesion should be treated with the best interventional techniques, so that we have a way of avoiding the occurrence of restenosis and the consequence of step-wise increases in costs for every redo procedure. Professor Zeller presented data from his own practice at Universitäts-Herzzentrum Freiburg Bad Krozingen showing that the use of DEB reduced by 70% from 2011 to 2012, but is set to rise in 2013 to levels higher than those Giancarlo Biamino seen in 2011, as DEB will become the workhorse for infrainguinal angioplasty. He then discussed a health economic analysis conducted by his team, in which they developed a budget impact model to estimate 24-month costs to payers for four SFA index procedure modalities: PTA; BMS; DEB; and DES. Conducting a systematic Medline search, the team identified a series of relevant clinical trials (see Figure Continued on page 32 More clinically relevant, longer term data are needed to validate the therapy value of each DEB technology. Giancarlo Biamino (Mercogliano, Italy) 31

32 Should we aim to leave nothing behind? Continued from page 31 4). The pooled results (Figure 5) showed a clear benefit with DEB, BMS and DES over PTA at 24 months, while DEB and BMS were the least costly index procedure (Figure 6), at per patient savings of 1480 for DEB versus DES and 1189 for DEB versus PTA. Furthermore, the number needed to treat to avoid one target vessel revascularisation over 24 months was approximately three for DEB versus PTA, and approximately 19 for DEB versus BMS. Professor Zeller therefore concluded that, taken together, DEB combines a leave nothing behind clinical benefit with economic value, and future reimbursement should consider this value proposition and balance it with provider incentives for adoption. Looking to the future, Professor Zeller explained to LINC Review: I personally assume that there will be one kind of major treatment modality which, in the future, will be the use of a drug-eluting balloon. The reason for this assumption is basically that what we learned here in Germany as a result of the missing reimbursement for drug-eluting balloons this year resulted in a drop-off of the cost of a drug-eluting balloon from 1,400 at the beginning of this year, about per balloon. So the overall the costs of drugeluting balloons worldwide will go down, not in parallel in every country but over the mid-term. I would assume drug-eluting balloons will not become more expensive than a bare nitinol stent. They should become even cheaper than a stent, if you simply consider the costs of producing such a drug-eluting balloon they are lower than the costs for a nitinol stent. He summarised: My expectation is basically that drug-eluting balloons will become the workhorse, but there will remain indications for other technologies, like atherectomy devices, for example, or thrombectomy devices. There will also remain probably some primary indications for stenting, like calcified lesions that tend to experience acute recoil after balloon angioplasty. So stents will not be out of the race in the future, but the stent rate will decrease tremendously in terms of the primary use of drugeluting balloons. That s my personal expectation of the future. References 1. Acin F, de Haro J, Bleda S, Varela C, Esparza L. Primary nitinol stenting in femoropopliteal occlusive disease: a metaanalysis of randomized controlled trials. J Endovasc Ther 2012;19: Figure 5 Figure 6 2. Scheinert D, Grummt L, Piorkowski M, et al. A novel self-expanding interwoven nitinol stent for complex femoropopliteal lesions: 24-month results of the SUPERA SFA registry. J Endovasc Ther 2011;18: Schulte KL, Kralj I, Gissler HM, et al. MISAGO 2: one-year outcomes after implantation of the Misago self-expanding nitinol stent in the superficial femoral and popliteal arteries of 744 patients. J Endovasc Ther 2012;19: Sabeti S, Mlekusch W, Amighi J, Minar E, Schillinger M. Primary patency of longsegment self-expanding nitinol stents in the femoropopliteal arteries. J Endovasc Ther 2005;12: Rocha-Singh KJ, Jaff M, Joye J, et al. Major adverse limb events and wound healing following infrapopliteal artery stent implantation in patients with critical limb ischemia: the XCELL trial. Catheter Cardiovasc Interv 2012;80: Scheinert D, Katsanos K, Zeller T, et al. A prospective randomized multicenter comparison of balloon angioplasty and infrapopliteal stenting with the sirolimuseluting stent in patients with ischemic peripheral arterial disease: 1-year results from the ACHILLES trial. J Am Coll Cardiol 2012;60: Tendera M, Aboyans V, Bartelink ML, et al. ESC Guidelines on the diagnosis and treatment of peripheral artery diseases: Document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteries: the Task Force on the Diagnosis and Treatment of Peripheral Artery Diseases of the European Society of Cardiology (ESC). Eur Heart J 2011;32: Cioppa A, Stabile E, Popusoi G, et al. Combined treatment of heavy calcified femoro-popliteal lesions using directional atherectomy and a paclitaxel coated balloon: One-year single centre clinical results. Cardiovasc Revasc Med 2012;13: My expectation is basically that drug-eluting balloons will become the workhorse, but there will remain indications for other technologies. Thomas Zeller (Bad Krozingen, Germany)

33 A DEFINITIVE commitment in PAD restenosis Delegates on Friday at LINC were privy to the latest update from the DEFINI- TIVE AR randomised pilot study (Covidien, Mansfield, Massachusetts, USA), designed to address the challenging restenosis rates in peripheral artery disease. Speaking about the rationale for the study, DEFINITIVE AR presenter Patrick Peeters (Bonheiden, Belgium) began by underlining that, in the present day, restenosis rates in the superficial femoral artery (SFA) are still too high. The factors associated with restenosis in peripheral interventions are lesion length, occlusions, diabetic patients, and the calcifications in these arteries, he said. While drug-coated balloons (DCB) are proving to be effective in the peripheral arteries, the rate of stent cross-over is relatively high (Figure 1). The use of self expanding stents, with chronic outward pressure on the vessel wall, may negate the benefit of one-time drug delivery that you do in the artery, said Dr Peeters. But it seems that primary dilatation with drug-coated balloons is definitely better than with normal balloons nobody knows why it happens. He continued, explaining that, as calcification and high plaque/ thrombus burden may inhibit drug uptake and limit the biological effect of the drug in the artery, it is thought that taking out this barrier and taking out the debris from the vessel gives you a better penetration of the drug inside the artery. So we think directional atherectomy prior to drug delivery could improve the outcome, added Dr Peeters. You do a mechanical recanalisation, without overstretching, remove the barrier and reduce the likelihood of bailout stenting. Dr Peeters then referred to the recent data published by Cioppa et al. 1 a prospective, singlecentre study that enrolled 30 patients (Rutherford class 3 6; Figure 1. Stent cross-over rates in recent clinical studies Thunder 1 Fempac 2 Levant I 3 Italian registry 4 Pacifier 5 Debellum 6 DCB POBA DCB POBA DCB POBA DCB DCB POBA DCB POBA N Length (cm) Stent rate (%) Tepe, NEJM 2008; 2.Werk, Circ 2008; 3. Scheinert TCT 2010; 4 Micari, JACC 2012; Werk, CCI 2012; Fanell, JEVT 2012 Figure 2. Example case from the early DEFINITIVE AR data heavily calcified lesions only). All procedures included distal protection with a SpiderFX embolic protection device (Covidien, Mansfield, Massachusetts, USA). You have to use this or you are going to have a peripheral embolism, he added. Within the study, once a <30% residual stenosis rate was achieved (as determined by intravascular ultrasound and angiography), a drug-coated balloon was used for post dilation. This <30% criteria was achieved in all cases, with no procedure-related major adverse events, with a bail-out stenting rate of 6.5%. At one year, primary patency (via duplex) was 90%, with a freedom from major adverse events of 87%. Dr Peeters commented: The authors concluded that directional atherectomy and drug-coated bal- Continued on page 34 We are still waiting for the results but we are true believers of debulking devices lining up with drug-coated balloons. Patrick Peeters (Bonheiden, Belgium) 33

34 A DEFINITIVE commitment in PAD restenosis Continued from page 33 loons may represent a potential alternative strategy for the treatment of femoropopliteal severely calcified lesions. But we need multicentre, randomised trials. With this in mind, DEFINITIVE AR was designed as a prospective, randomised, controlled multicentre trial, with the primary purpose of assessing and estimating the effect of treating a vessel with directional atherectomy in combination with a DCB compared to treatment with DCB alone. One hundred patients have now been enrolled who have lesions of 7 15cm in length (i.e. TASC C lesions) in the femoropopliteal arteries, and claudication (Rutherford class 2 4). An additional 25 subjects with a severely calcified target lesion will be eligible for enrolment in a non-randomised treatment arm with directional atherectomy and DCB. Follow-up assessments will occur at pre-discharge, 30 days, six months and one year postprocedure. The primary outcome of the study is a target lesion percent stenosis at one year, defined as the narrowest point of the target lesion divided by the estimated native vessel diameter at that location, as determined by the angiographic core lab (assessed by one year follow-up angiogram). The enrolment was completed in December [2012], so now we are only enrolling heavily calcified patients, said Dr Peeters. Figure 2 shows angiographic data from one of the patients enrolled in the study. To treat the very calcified long SFA lesion (almost 18cm in length), the team used recanalisation followed by debulking (the debris that was removed is visible on the lower right corner of Figure 2) and finally a drug-coated balloon. Offering his final comments during his presentation, Dr Peeters said: We are still waiting for the results but we are true believers of debulking devices lining up with drug-coated balloons. In response to the presentation, session chairman Ralf Langhoff (Berlin, Germany) commented that, while the combination of atherectomy and DCB was interesting, he wondered whether atherectomy needed the drug-coated balloon, or the drug-coated balloon needed atherectomy?. De Peeters added: I really think that when you deliver the drug, and when you deliver the balloon, and the drug is on the balloon, I m sure that when you take out the core, you have better penetration of the drug inside the artery. So the effect of the drug should be better, but we have to prove this. Session moderator Lawrence Garcia (Boston, USA) commented: It s a very important question, because, even though DEFINI- TIVE LE was not a randomised trial (more a kind of prospective registry), you still get the idea you will get this drug effect for the medium lesion group in the SFA, which is what DEFINITIVE AR studies, and then you ll see some incremental growth in patency. He added: The benefit could be in the 90% range for primary patency, which would be that ultimate Holy Grail I think it s going to be a very intriguing year when DEFINITIVE AR gets published. Reference 1) Cioppa, C, et al. Cardiovasc Revasc Med 2012; 13: The benefit could be in the 90% range for primary patency, which would be that ultimate Holy Grail I think it s going to be a very intriguing year when DEFINITIVE AR gets published. Lawrence Garcia (Boston, USA)

35 An Interview with Stacy Enxing Seng, President, Covidien Vascular Therapies Q: What is Covidien Vascular Therapies strategy for outperforming the market? A: As a global business, Covidien Vascular Therapies aspires to be the clear first choice for our customers, employees, investors and business partners by delivering breakthrough innovation in the treatment of vascular disease worldwide. We work hard every day to achieve this goal by staying focused on the technologies and initiatives that our physician customers tell us are vital to achieving the best possible outcomes for their patients. Vascular Therapies is growing rapidly, and to build on our momentum, we need to continue embracing and investing in the collaborative relationships that we have with medical professionals around the world. By continuing to listen to the medical community and observing them in action, we can deliver game-changing products, supported by solid clinical evidence, that address unmet needs. By staying this course, I strongly believe that we will transform our business into the leading vascular company worldwide. Q: What distinguishes Covidien in the highly competitive vascular market? A: We not only have the right combination of talent and technology at Covidien, we are also focused on common and often compassionate goals. The result is an energized and empowered community of out-of-the-box thinkers who are also practical problem solvers all clearly motivated by the opportunity to have a profound and positive effect on patients lives. It s impressive. And this is not just happening in research & development and sales and marketing it s what drives our entire organization. At Covidien, we offer a diverse yet complementary range of technology solutions to treat vascular disease, including deep vein thrombosis, chronic venous insufficiency, dialysis access, peripheral vascular disease and neurovascular disease. We are always looking to grow our leadership position in the businesses we are in today, while laying the groundwork for tomorrow to lead in new and emerging areas, such as hypertension and ischemic stroke treatment. Q: What emerging market trends will be a focus for Covidien in the coming years? A: We are particularly excited about the vascular treatment of hypertension as a procedure that can be conducted by the interventional cardiologist, vascular surgeon and interventional radiologist. To meet this widespread and growing public health need, we entered the hypertension market with the OneShot Renal Denervation System for the treatment of drug resistant hypertension, a devastating condition affecting millions of people worldwide. As a recognized leader in radiofrequency ablation technology, we saw this as an opportunity to leverage our technical expertise to provide the market with a unique way to address hypertension. We will continue to ensure that the products and services we develop and provide are clinically relevant and economically beneficial. Our customers are under ever increasing pressure to justify the procedures and products they use, whether they are physicians in a small private practice or hospitals in a large healthcare system. Our responsibility is to make sure that Covidien products are economically valuable, while helping customers provide the highest standard of care. Q: What new products and technologies can we expect from Covidien in the next 12 to 18 months? A: Covidien just introduced the Viance Crossing Catheter and Enteer Re-entry System, which offers a new way to treat chronic total occlusions (CTOs) in peripheral arteries. These new products take a unique approach, leveraging physician skill and finesse rather than the use of force or expensive capital equipment. We continue our innovative approach with the recent launch of our clinically proven EverFlex stent on the new Entrust delivery system which was developed in close collaboration with physicians to ensure we match their clinical needs. Engineered for easy-to use, one-handed stent delivery, the EverFlex Entrust delivery system offers a unique combination of features designed for optimal control, accuracy and consistency even when treating patients with complex conditions. 35

36 Leaps and bounds in below-the-knee therapy ISET and LINC joined forces with great verve on Wednesday to discuss innovations in popliteal and below-the-knee (BTK) therapy. Chaired by ISET Course Director Barry Katzen from Miami, USA, and Dierk Scheinert from Leipzig, the session focussed heavily on featured research, and included live procedures. With the much-anticipated 12-month results from the SUPERB (Comparison of the SUPERA PERipheral System to a Performance Goal Derived from Balloon Angioplasty Clinical Trials in the Superficial Femoral Artery) study 1, Eric Dippel (Indiana, USA) stood in for Kenneth Rosenfield to speak live from Miami. Developed with high radial strength, combined with high flexibility, kink resistance and fracture resistance, the SU- PERA interwoven nitinol stent (Idev Technologies, Webster, Texas, USA) demonstrated the highest reported primary patency rate (86%) at one year of any superficial femoral artery (SFA) stent trial to date. Two hundred and sixty-four patients were enrolled in 34 sites for the study, and results were compared to VIVA performance criteria with a goal of primary patency of at least 66%. The primary safety endpoints were traditional, comprising death, target lesion restenosis (TLR) and amputation at 30 days. Primary efficacy endpoints were freedom from restenosis or freedom from TLR. Inclusion criteria were typical claudication in Rutherford Class 2 to 4, without ulceration, popliteal lesions, and having at least a single vessel run-off to the foot. Implanted stents ranged from 4mm to 6mm in diameter, with lengths from 40mm to 150mm. Similar to other SFA studies, two-thirds of subjects were male, 43% were diabetic, and 9% had renal insufficiency. The majority fell into Rutherford class 3, and mean lesion length was approximately 8cm. 73% of patients had at least moderate to severe calcification, and a quarter of patients had chronic occlusions. Almost 90% of patients improved in Rutherford-Becker score, with 50% improving by three grades. Detailing the very promising outcomes of the study, Dr Dippel said: The primary safety endpoint demonstrated a 30-day event-free survival rate of 99.6%. There was one patient that had a toe amputation; no death; no TLR. This exceeded the VIVA criteria for safety, which was set at 88%, making this a statistically significant finding. The primary patency endpoint using Kaplan-Meier analysis demonstrated a six month patency of 98% with a 12 month patency of 86.1%. Freedom from TLR was 90%. The SUPERA stent may represent a new standard in SFA stent design, concluded Dr Dippel. Unlike bare metal or drug-coated stent SFA trials under investigational device exemption (IDE), the SUPERB study has demonstrated a 0% fracture rate. With the SUPERA stent showing increased patency compared with other SFA IDE studies for similar lesion lengths, it does indeed appear to be raising the benchmark. With further news of the SU- PERA stent from Leipzig, Professor Scheinert presented long term follow-up data from the SUPERA 500 registry 2. This large single centre registry formed a retrospective analysis of 495 patients undergoing treatment of femoral and popliteal arteries, with a total of 750 SUPERA stents deployed and 528 treated legs between 2008 and The patient cohort was typical, although 50% were diabetic. The majority of patients were in Rutherford class 3, with classes 3 to 5 accounting for about 70% of cases. 278 occlusions (52%) were treated. The majority of stents (85%) were placed into the distal SFA or popliteal artery. In many cases, due to long stent segments, the stent extended into more than one arterial segment. A lot of patients had longer lesions involving the popliteal artery. The mean number of stents was 1.4, with a maximum of 5.0 in a single patient. As stents were placed in 1:1 ratio with the reference vessel diameter, the majority of patients received 5mm stents. Another 20% of patients received 6mm stents, and 4mm stents were quite rare. The overall primary patency rate was 84% according to angiography and duplex at 12 months, and 73% at two years (see Figure 1). These results are highly comparable to the results of the SUPERB study. The mean stented length was above 12cm, and patency varied according to lesion length (see Figure 2). Popliteal lesions did as well as the superficial femoral artery lesions, although the popliteal lesions were slightly shorter than those in the SFA. Rutherford-Becker scores were reduced from a mean of 3.0 to 1.9 at the latest follow-up. The results of the SUPERA 500 registry confirm previously reported results, said 36 The SUPERA stent may represent a new standard in SFA stent design Eric Dippel (Indiana, USA)

37 Professor Scheinert, Particularly the ones from the SUPERB IDE study in what I would call a real world setting, because they have been used in our institution for many patients over a long period of time. I think they compare quite favourably for data for other nitinol stents, and also they do compare quite favourably with data for drug-eluting stents. Johannes Lammer (Vienna, Austria) next took to the podium in Miami with a presentation on SFA endoluminal bypass versus bare stents for femoropopliteal occlusive disease. We have heard results from randomised trials comparing bare metal stents with drug-eluting stents with percutaneous transluminal angioplasty (PTA), he said. However, all these data are based on very short lesions of the SFA. We know now that we can, using retrograde and anterograde techniques and recannalisation devices, recannalise almost every lesion and also therefore long lesions such as TASC C and D lesions. In order to shed light on the best approach for longer lesions, the ongoing VIASTAR trial (GORE VIABAHN endoprosthesis with bioactive propaten surface versus bare nitinol stent in the treatment of TASC B, C and D lesions in superficial femoral artery occlusive disease) 3 compares Viabahn (W. L. Gore & Associates, Flagstaff, Arizona, USA) with bare metal stents, with the Viabahn stent possessing contoured proximal edge and heparin coating. Follow-up took place at 12 months and is ongoing up to two years post-procedure. A multicentre randomised trial based in Austria and Germany, the inclusion criteria were claudication or CLI. Lesion requirements were SFA or P1 stenosis, or occlusions, between 10cm and 35cm in length. In addition, at least one tibial artery run-off to the ankle had to be present. Eight per cent of subjects were claudicants and a little less than 20% had CLI. 70% to 80% of lesions were totally occluded, and the mean occlusion length was between 17cm and 19cm. Primary patency analysis indicated very favourable results for the Viabahn stent, with one year patency of 78% versus 53% for the bare metal stent. For lesions of 20cm or greater length, a 73% patency rate resulted for the Viabahn group and 33% for the bare metal stent group. However, in shorter lesions of 10cm to 20cm, there was no significant difference between cohorts. These preliminary results indicate that those treated with bare metal stents are three times more likely to lose patency compared with those implanted with the Viabahn stent at the same TASC level. However, as panellist Peter Gaines (Sheffield, UK) noted, the rapid advent and growing popularity of drug-eluting stents and balloons perhaps necessitates further comparative trials. Technology is moving forward so fast, said Dr Lammer, explaining: When we planned our trial, there were only the failed SIROCCO 4 and the failed STRIDES 5 trial, and we didn t have the results of the Zilver PTX. Now we should have a trial comparing the drug-eluting stents, the Zilver PTX and the Viabahn. However, because it seems that they are very close, this would be a huge study to see which is different. We may accept that both are equal and then we as operators have the option to choose either one. In the subsequent live procedure broadcast from Miami s Baptist Cardiac & Vascular Institute, Alex Powell (Florida, USA), Jim Benenati (Florida, USA) and Juan Gomez (Florida, USA) presented the case of a 64-year-old male with bilateral popliteal aneurysms, a history of abdominal aortic aneurysm status, post-endovascular aortic repair (EVAR), hypertension and coronary artery disease. A month after EVAR, the patient developed acute lower right extremity pain, with distal emboli in the tibioperoneal vessels that were related to a known 4cm popliteal aneurysm. The patient had successful thrombolysis and reconstruction of the artery with overlapping stent grafts. The patient had now returned for the repair of the smaller popliteal aneurysm on the left side. Scans over the past year indicated a slowly growing aneurysm, although there was no evidence of distal embolisation, and run-off to the foot was preserved. Given the presence of an additional smaller SFA aneurysm and regions of calcification, the team opted for vascular repair and Viabahn stent grafting (7/150mm) of this aneurysm under anticoagulation, continuing the graft up to the mid-sfa. After deployment, the stent was smoothed using a ballooning procedure, after which it was inspected for folding using intravascular ultrasound (IVUS) and tested under flexion. Describing the pertinence of this particular case, Dr Powell said: It shows the natural history of what Continued on page 38 The results of the SUPERA 500 registry confirm previously reported results, particularly the ones from the SUPERB IDE study. Dierk Scheinert (Leipzig, Germany) 37

38 Leaps and bounds in below-the-knee therapy Continued from page 37 can happen to these popliteal artery aneurysms. And while the left side is not particularly large, it has grown a little bit. In the previous history, it is clearly indicated that this is a person that has embolised previously and this warrants treatment. While the patient s previous aortic treatment excluded the up and over approach, anterograde access was successful via the left leg. Aside from the SFA aneurysm, an area of calcification and an additional small aneurysm were present in the distal SFA. Of course, the most important aspect is the popliteal artery aneurysm itself, the distal landing zone and three-vessel run-off, said Dr Powell. We have a marking catheter in place one of the critical components of this is putting the right sized pieces in. Measurement is key to this case. We don t want to have too big a piece because of the potential for in-folding. Obviously, too small won t give us a seal. Dr Benenati then detailed the knotty sweep of the femoropopliteal region, leading him to conclude that stenting up to the SFA was a good option in this case. Using intravascular ultrasound, he described: We re coming through into the [popliteal] aneurysm. As we come out of the aneurysm, there are some areas of minor plaque. Dr Benenati moved on to inspect the region of the SFA aneurysm, saying: There is a focal stenosis that is heavily calcified. We certainly don t want to leave that stenosis above the graft. That helps us determine how high up we are going with the graft. Even though that aneurysm is very small compared to the aneurysm at the knee joint, we are concerned about the plaque, the calcium, and leaving that behind if we just stent below this segment. The choice of stent placement was limited, but it nevertheless raised quite some debate between attending physicians and panelists on both sides of the Atlantic. Placing a large stent over the flexion point of the femoropoliteal region has raised issues in the past when less flexible stents have been deployed. However, placing sequential smaller segments of stent could potentially create complications between procedures relating to thrombus formation, even though the aneurysm was growing relatively slowly. Identifying healthy landing zones at either end was critical to the success of the case. Distally, the long landing zone prepared for the scenario in which the patient needed a femoropopliteal bypass. For this reason, the length below the knee to the bifurcation and trifurcation was not treated. On the Leipzig panel, surgeon Reza Ghotbi (Munich, Germany) summarised the evolution of this procedural approach, saying: In my experience after 100 cases of endovascular treatment of popliteal arteries, if we have trouble in follow-up time, they arise from the first popliteal segment. In the first few years, we tried to get the reconstructions limited to the aneurysm, but degeneration of the first segment of the popliteal artery is really significant after three to four years. So we shifted to another strategy: we cover the first section of the popliteal regardless of stenosis and diameter with ISET Viabahns, and the results are now definitely better. References 1. NCT html 3. RCTN gov/pubmed/ We know now that we can, using retrograde and anterograde techniques and recannalisation devices, recannalise almost every lesion. Johannes Lammer (Vienna, Austria)

39 A matter of balance Trade-offs between profile size and structural integrity are a common issue in the design of endovascular aneurysm repair (EVAR) devices, but novel instrument makers are finding new ways to improve each of these characteristics without detriment to the other, delegates heard during a symposium addressing aortic challenges on Friday at LINC. In his presentation, Ross Milner (Chicago, USA) described the relationship between low profile and device integrity in more detail a subject he described as a slippery slope in the quest for better devices. We forget that the main reason we need these devices is to treat aneurysms, and we don t want endoleak problems, he added. Looking briefly back over the history of EVAR devices, Dr Milner noted that, since their inception in 1991 by Dr Parodi 1, there have been a tremendous number of iterations in the available devices for treating patients. However, while newer technologies have paved the way for better EVAR treatment, the mistakes and problems associated with a number of devices has also been a valuable lesson. Throughout the last 20 years there have been many instances where devices have been taken off the market, for a variety of reasons. The main reason we need to be familiar with is when the device fails due to lack of efficacy, because of device-related issues, said Dr Milner. As such, he added that a balancing act of sorts is needed when designing new EVAR devices. Dr Milner continued: What we are trying to decide is what is more important? Is it low profile or is it the integrity of the device? You have to balance the two to figure out what is going to be the most valuable. If you weigh too heavily towards low profile, the likelihood is there is something that has to be done with the device to make it more low profile, which potentially impacts the integrity of the device. With this in mind, we must therefore be cautious to not focus too heavily on low profile characteristics, in turn compromising the integrity and durability and leading to retraction of the device from the marketplace. This is why we need devices that are able to deal with challenging anatomy, but at the same time have the integrity to appropriately seal off the aneurysm, said Dr Milner. So what if you tip the balance the other way, and have device integrity outweighing low profile? From his perspective, Dr Milner believes device integrity is more important than a low profile design, particularly with respect to preventing endoleaks. In terms of radial strength, low profile devices can suffer from insufficiencies in this arena which in turn means they struggle in challenging, tortuous anatomies. So again, if you look at this, and if you favour the integrity of the devices compared to low profile, we can do better, he added. That being said, Dr Milner stressed that striving for a low profile should not be overlooked, especially in cases where conduit strategies are utilised during EVAR, whereby there may be less need to deal with challenging anatomies. One manufacturer that has been striving to improve the overall combination of integrity and profile within their devices has been W. L. Gore & Associates (Newark, Delaware, USA). Dr Milner described the steps that have been taken to achieve this, focussing on the GORE EXCLUDER device. The way this was done was not by changing anything that has to do with the device itself, in terms Continued on page 40

40 A matter of balance for innovative EVAR devices Figure 1. Profile comparisons of the current and newly-revised GORE EXCLUDER EVAR device family Figure 2. Reduced profile size, improved sleeve material and a better delivery system are all incorperated into the revised GORE EXCLUDER design Continued from page 39 of the actual implant that is put in the patient, but dealing with the delivery system in such a way that the sleeve can be changed, and the profile can be changed within the delivery system, he explained. Figure 1 shows the significant reduction in profile that has been achieved throughout the range of GORE EXCLUDER applications. As an example of the new design, Figure 2 shows a comparison of the 16mm contralateral leg system in both current (established) and newly-revised formats. As can be seen, the French size is reduced from 18 to 12, and the new stretchable polytetrafluoroethylene polymer, eptfe, is introduced to improve the sleeve. Furthermore, there is also a more flexible leading olive similar to the GORE C3 delivery system. It is still the same durable device, said Dr Milner. There is excellent clinical data available already for the efficacy of the device and a lot of peer-reviewed publications supporting this. From the [2012] clinical update, if you look at the success there has been a huge number of implants, very low rupture rates, very low migration rates, and excellent patency and proven device durability. So when I look at the balancing act from my perspective, what we would like ideally is a low profile device that has unbelievable integrity so we can have durability for success for our patients. Low profile is very valuable, device integrity I think is also very valuable and potentially even more valuable than low profile but neither aspect can really be compromised to maintain patient safety and efficacy of aneurysm repair. I think the recent changes by Gore have focussed on both of these aspects, and allowed an improved device that will still give us the same durability that we are accustomed to with the EXCLUDER for treating aneurysms. References 1. Parodi JC, Palmaz JC, Barone HD. Transfemoral intraluminal graft implantation for abdominal aortic aneurysms. Ann Vasc Surg 1991;5: There is excellent clinical data available already for the efficacy of the [GORE EXCLUDER] and a lot of peer-reviewed publications supporting this. Ross Milner (Chicago, USA)

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42 Showing promise in SFA and popliteal aneurysms Chairing the symposium Unique technologies for the treatment of SFA and popliteal aneurysmal disease on Thursday, Peter Soukas (Rhode Island, USA) demonstrated the versatility of the Gore Viabahn stent (W. L. Gore & Associates, Flagstaff, Arizona, USA). With a quick-fire selection of cases of arteriovenous fistula (AVF), aneurysms and potentially life-threatening perforations, he also talked about its good viability in long superficial femoral artery (SFA) lesions, with some encouraging data on in-stent restenosis. Dr Soukas described the VIPER (Gore Viabahn Endoprosthesis with Heparin Bioactive Surface in the Treatment of Superficial Femoral Artery Obstructive Disease) study, which aims to provide performance data on the Viabahn in terms of mitigating graft occlusion and edge stenosis. We know that patency for covered stents is independent of lesion length, he said. It is also important to remember that there are significantly different patterns of restenosis: short, focal edge stenosis versus diffuse proliferative stenosis, and that covered stents placed endovascularly have the same patency rate as a prosthetic stent graft. Very important to remember not to oversize the device oversizing of devices in the VIPER trial definitely led to a higher incidence of graft failure. When you look at these long lesions, because of the independence of patency with regards to lesion length, you can see that, in the VIPER trial, primary patency was really quite excellent. Dr Soukas also praised the Viabahn for its applications in cases of in-stent restenosis. There have been a number of single-centre studies looking and reporting on their experience with Viabahn for in-stent restenosis, including our own. In our particular place, we looked at our experience in 27 patients who had a lot of different comorbidities. We used laser in about 36% of cases and cutting balloon in the remainder. We also had outflow interventions in about 39% of patients. With all that, we were rewarded with 85% primary patency at 1 year, and a 3-year primary patency rate of 81%, and 96% secondary patency. With a reminder that it is the cook, not his tools, who makes the broth, Dr Soukas concluded: Viabahn is a very useful non-surgical treatment for AVF and aneurysm disease, and can be a life-saving treatment for patients with vessel perforation and retroperitoneal hemorage. We anticipate that the current Viabahn with proximal contoured edge and heparin bonding, does and will continue to improve patency. But it is important to remember that proper sizing and technique are really essential to good outcomes. Dr Piorkowski followed Dr Soukas by sharing his early clinical experience with the next generation of dual component stent, namely the Tigris stent (W. L. Gore & Associates, Flagstaff, Arizona, USA). When [Gore] came the first time to our hospital showing us this stent we thought, why do we need another stent for the femoropopliteal region?, Dr Piorkowski candidly began, before explaining the difficulties that arise from simpler stent designs. The problem with all stents is that they are all laser-cut nitinol tubes. The normal SFA has really severe compression and extension forces, flexion above the knee joint and below it. We have all seen the pictures where fractured stents destroy a vessel, and obviously they aren t patent any more. The helical or segmented structure of the stents are connected by small nitinol bridges, and when the engineers at Gore thought about it to overcome this, they used their own material they had in the company PTFE [polytetrafluoroethylene]. This material is quite good to overcome this problem. It obviously makes the stent very resistant to elongation, but you also can compress it. Preclinical experimentation demonstrated good performance under longitudinal force in comparison with other nitinol stents. Its lack of elongation may also aid stent deployment, and the heparin-bound bioactive surface is designed to prevent clot formation and stent thrombosis. Describing his clinical explorations, Dr Piorkowski said: We treated, between September 2011 and October last year [2012], 32 patients with 40 lesions. We had ten women in this small cohort, with a mean age of 33 years. They all suffered from hypertension, diabetes, and had some moderate to severe renal failure. There were also some active smokers. From a clinical perspective, we included claudicants up to critical limb ischemia. Lesion lengths under treatment were naturally short due to the paucity of knowledge as to how the stent would behave in longterm, real-world scenarios. We treated two CTOs, and 90% degree stenosis in SFA and popliteal lesion in a small number of cases, said Dr Piorkowski. We treated the medial to distal SFA, but also the segment of the popliteal artery where you have a lot of vessel movement. The lesions were not that calcified but we had four people with really, really high grade calcified stenoses. Forty three stents were implanted with a mean diameter and length of approximately 6mm and 62mm, respectively. Mean dilation was 5.3mm. No severe residual stenosis occurred. At the time of his talk, the trial had completed the three month follow-up period. We have improvement in Rutherford-Becker category from 3 to 1.5, said Dr Piorkowski. There is also an improvement in the ankle-brachial index from pre- to post-intervention from 0.75 to 1.0. This stent is a very innovative, hybrid design with less nitinol, high flexibility. It can easily absorb longitudinal compression. It does not get elongated so it is very easy and exact to implant. It mimics the vessel movement and we are waiting for long-term data patency. Of course, there is enrollment for a trial comparing this stent to a normal Bard Lifestent [Bard Peripheral Vascular, Tempe, AZ], so we are very keen for this data. 42 We anticipate that the current Viabahn does and will continue to improve patency. Peter Soukas (Rhode Island, USA)

43 Treating extreme patients becoming routine practice The way advances in device design and deployment can transform the prospects of previously hard-to-treat conditions came under the spotlight at LINC 2013, when the experiences todate with the Ovation Abdominal Stent Graft System (TriVascular, Inc., Santa Rosa, California, USA) were presented. Incorporating a live case transmission from Leipzig, the session examined the European and US perspectives on using Ovation to treat the most challenging cases, as well as looked at the latest data from the OVATION post-market registry. Alongside all of that, the session featured a presentation by Thomas Nolte (Bad Bevensen, Germany) updating delegates on the global pivotal trial data with this important device. LINC Review spoke to Dr Nolte ahead of his presentation to talk about abdominal aortic aneurysm (AAA) and why it is that the innovations in Ovation have proved to be so crucial. He said: As patients get older, there s a longer time for the development of AAA, as well as the development of peripheral artery disease, or the chance that access routes are diseased or have undergone prior treatment with, let s say, stents or something like that. Thomas Nolte In addition, he continued: Many of the so-far available grafts needed to be inserted via a sheath with an outer diameter of 22 French, which meant that, in many cases where you have obstructed access routes, in the past you had to neglect the possibility of performing EVAR [endovascular aneurysm repair] to exclude the aneurysm. All that changed with Ovation. Ovation is, besides the advertising, indeed the so-far only commercially available device with a low-profile up to 14 French in the common sizes. If you go for the biggest main body you have 15 French system but that s not in common use. Turning to how institutions are adopting Ovation, Dr Nolte said: For example, looking at our unit, which is a high-volume unit specialising in the maximum care of vascular patients, we switched from at least 30% endovascular treatment of AAA to 80% using Ovation as first-line device. It s also for us an option to use it in ruptured cases, where it has become part of daily practice. However, it is not the experience of a single unit that is most important to clinicians contemplating the device. As Dr Nolte observed: The Figure 1. Case 1. AAA with hostile neck and difficult access (72-year old man) first grafts within the pivotal study, which I ran as principal investigator, show at two years excellent results, with no technical failure, no type 1 endoleak, and no migration. The mechanism of sealing is interesting too, and no signs of enlargement in the neck, which is one of the, let s say, major questions you hear from the audiences. Most of them say that there must be a natural enlargement of the aneurysm neck but I think, looking at the data from the growing Figure 2. Case 1. EVAR with Ovation April 2010 completion angiography numbers of patients treated with Ovation, one has to reconsider this idea of natural enlargement of the aortic neck. He continued: The difference between an uncovered aortic neck and an open surgical situation, or after treatment with those devices that rely on continuous radial force for sealing, is that Ovation, once deployed, and sealing the rings with the polymer, leads to pressure offload of the attached aortic wall. This is one hypothesis that may explain the findings in the Figure 3. Case 1. Follow-up at 1 month postoperative survey of 28 patients from the original pivotal study and at least 200 patients in the registry, which has so far been conducted as a second scientific evaluation of the performance of ovation. So that begs the question as to whether the registry data, which represents a more real world experience, matches up to the original trial data. Dr Nolte said: Of course, the trial data might come from, let s say, a closed shop, with a special safety conditions. Continued on page 44 Figure 4. Case 1. Follow-Up two years successful AAA exclusion with sac shrinkage by 30%, no sign of migration Many of the so-far available grafts needed to be inserted via a sheath with an outer diameter of 22 French, which meant that in the past you had to neglect the possibility of performing EVAR [endovascular aneurysm repair] to exclude the aneurysm. Thomas Nolte (Bad Bevensen, Germany) 43

44 Treating extreme patients becoming routine practice Continued from page 43 But going back to the pivotal study, at least 26% had really narrow access routes. Perhaps the same percentage of patients was treated, despite a neck length of 10mm and less. So if you add up all those conditions, at least one third of the patients, even in the pivotal study, was treated with anatomical conditions you would define as difficult-totreat with endovascular devices. Dr Nolte was asked about the learning curve with the Ovation device. He replied: There is a distinct learning curve using this device but that equals the learning curve you encounter using other grafts. It s always quite different to use different devices, and there s some characteristics of Ovation that are very different to other devices because there s no, for example, fixed endoskeleton as with stents and wires or something like that. In addition, you have the fixation crown, which provides secure fixation of the graft. Dr Nolte added: During the deployment period, the entire prosthesis is very floppy, moving within the blood flow, and this endoskeleton, which provides stability, on the one hand and sealing on the other hand, is created during the procedure by injection of the polymer. The polymer sets within 20 minutes. After that time, the syringe containing the polymer can be disconnected and you will not experience any spill of polymer into the blood flow. To see two case examples of Ovation being used in the treatment of AAA provided by Dr Nolte, as well as the device itself, see Figures 1 6 (pages 43/44). Also speaking at the symposium was Lieven Maene (Aalst, Belgium), who presented the European perspective on treating the extremes with Ovation. We asked him his thoughts on why an entire session at LINC was being devoted to the discussion of a single device. He replied: Why is it important? For me, because it s a new era the development of an endoprosthesis, with a new focus on sealing, and the separate consideration of the sealing and the fixation. That s a new development in the whole history, the whole evolution, of EVAR. So what does that allow us to do? If you have separate sealing, and a new type of sealant, then the sealing zone can, first of all, be shorter, Dr Maene explained. With conventional endoprosthesis, you mostly need a sealing area of about 1.5cm to 2cm. With Ovation, the sealing zone can be reduced to about 7mm. He continued: On a clinical level, that means that a lot of patients who have very difficult sealing zones the infra-renal sealing zone is a challenge in a lot of patients can still be treated with this new type of prosthesis. Plus, the risk of an endoleak is much higher with the conventional type of sealing. What is Dr Maene s interpretation of the picture in Europe of treating extreme cases with Figure 5. Case 2. Ovation Genuine intraoperative visibilty Ovation? He said: I think the European perspective is that a lot of patients who are now unsuited for EVAR will have the possibility to be treated with the new type of endoprosthesis, with good longterm results, so that the minimal invasive procedure can be offered also to patients with very challenging anatomy. He added: We ve discussed mostly the sealing, but another very important aspect is the access of this new type of delivery system Figure 6. Case 2. Ovation Completion angiography shows patency and sealing allows. It means that this endoprosthesis is delivered in a very low-profile device, so that a lot of patients who have an unsuitable anatomy for conventional devices are still able to be treated with this type of endoprosthesis. Although, Dr Maene noted that other companies are also working on this, but every size reduction can be beneficial. The major difference is the type of sealing of this endoprosthesis, he concluded. 44 With conventional endoprosthesis, you mostly need a sealing area of about 1.5cm to 2cm. With Ovation, the sealing zone can be reduced to about 7mm. Lieven Maene (Aalst, Belgium)

45

46 When evolution becomes revolution in iliac and SFA les A special session dedicated to the latest developments in iliac and SFA technologies took place on the Friday morning, with special attention paid to the impressive results achieved with stenting in TransAtlantic Society Consensus (TASC) C and D lesions in the iliac arteries and the use of resorbable scaffolds in the superficial femoral artery (SFA). After a live case transmission from Leipzig, Koen Deloose (Dendermonde, Belgium) took to the podium to discuss real-life experience and long-term data in iliac stenting with two-year data from the BRAVISSIMO (Belgian-Italian trial investigating Abbott Vascular Iliac StentS In the treatment of TASC A, B, C & D iliac lesions) study. He began by asking, when looking at real-life experience, how one should treat TASC A lesions, TASC B lesions, TASC C lesions, and even TASC D lesions. Based on the TASC II recommendations, 1 he noted, one would treat TASC A and B lesions with endovascular interventions, while TASC C and D would be left for surgery. However, his real-life experience tells him that while TASC A and B lesions should indeed be treated endovascularly, the first approach for TASC C and D lesions should also be with endovascular management. Dr Deloose pointed out that, while there have been a number of publications supporting the notion of using endovascular interventions in TASC C and D lesions, the vast majority have been retrospective, single-arm, non-randomised studies. Nevertheless, there is more data to support the concept. Specifically, he turned to the MOBILITY trial, 2,3 which was a prospective, non-randomised, multicentre, two-arm study to Figure 1. Lesion Characteristics evaluate the safety and effectiveness of the Absolute Pro (Abbot Vascular, North Chicago, Illinois, USA) vascular self-expanding stent and Omnilink Elite (Abbot Vascular, North Chicago, Illinois, USA) vascular balloon-expandable stent when used to treat de novo or restenotic atherosclerotic lesions in the native common iliac artery or the native external iliac artery in individuals with peripheral artery disease. The primary endpoint was major adverse events (MAE) at nine months, defined as death, myocardial infarction (MI), major amputation and clinically Figure month primary patency. TASC A and B lesions driven target lesion revascularisation (TLR), with follow-up at one and nine months and at two and three years. With Absolute Pro, the rate of MAE at nine months among 151 patients and 181 lesions was just 6.1%, while the rate with Omnilink Elite among 153 patients and 241 lesions was 5.4%. Furthermore, the rate of death, MI, ipsilateral major amputation, and clinically driven TLR with Absolute Pro was 2.7%, 1.4%, 0.7%, and 1.4%, respectively, and was 0.7%, 0.7%, 0.0%, and 4.0%, respectively with Omnilink Elite. Finally Dr Deloose noted that event-free survival from clinically driven TLR at up to 326 days post-procedure was 97.1% with Absolute Pro, and 94.9% with Omnilink Elite. Turning next to the main focus of his presentation, Dr Deloose discussed the BRAVISSIMO study, which had a primary endpoint of primary patency at 12 months on duplex ultrasound, defined as a target lesion without a haemodynamically significant stenosis on duplex ultrasound (>50%, systolic velocity ratio 2.0) and without TLR within 12 months. He noted that one of the secondary 46 TASC classification nor lesion length was (independently) predicitive of restenosis, while kissing stents and obesity were good predictors. Koen Deloose (Dendermonde, Belgium)

47 ion management Figure month primary patency. TASC C and D lesions endpoints was primary patency at 24 months on duplex ultrasound, without prior TLR. Of the 325 patients, who were from Belgium and Italy, 190 had TASC A/B lesions, while the remainder had TASC C/D lesions. The lesion characteristics in the study are shown in Figure 1. Overall, 147 patients received Absolute Pro, 151 received Omnilink Elite, and 27 patients received both stents. Omnilink Elite stents were more commonly used in TASC A patients, while Absolute Pro was used most in TASC B and C patients. At the beginning of the study, the vast majority of patients (164) were in Rutherford class 2 and 3, and none were in Rutherford class 0 or 1. At six-months followup, this picture had completely reversed, with 269 patients in Rutherford class 0 and 1, and just 26 in Rutherford class 2 and 3. This distribution was largely maintained up to 24 months follow-up. Overall primary patency at 12 months was 93.1%, which translated into 94.0% and 96.5% among TASC A and B patients, respectively (see Figure 2) and 90.2% and 91.3% among TASC C and D patients, respectively (see Figure 3). Dr Deloose also explained that 12-month primary patency was 96.1% with Absolute Pro, 91.8% with Omnilink Elite, and 84.4% with both stents, which represented a non-significant difference. Multivariate analysis indicated that the only significant predictors of restenosis at 12 months were the use of a kissing stent or the presence of obesity, at hazard ratios of and Restenosis was not independently predicted by TASC classification or lesion length. Moving on to the long-term results, Dr Deloose revealed that the overall primary patency at 24 Figure month primary patency months was 87.9%, at 88.0%, 88.5%, 91.9% and 84.8% in TASC A, B, C and D lesions, respectively (see Figure 4). Primary patency at 24 months was 92.1% with Absolute Pro and 85.2% with Omnilink Elite, and 75.3% with both stents. Again, the difference was not significant. To conclude, Dr Deloose commented: Prospective, controlled, multicentre trials confirms the findings of earlier retrospective data concerning excellent results of endovascular repair in all iliac lesions. He added: The MOBILITY trial shows high freedom from clinically driven TLR at nine month [and] the BRAVISSIMO trial reports excellent 12 and 24 months primary patencies, without any statistical difference in the various TASC groups. Dr Deloose ended by saying: TASC classification nor lesion length was (independently) predicitive of restenosis, while kissing stents and obesity were good predictors. After returning to the live case transmission, and a presentation on treatment technologies in the superficial femoral artery by Richard Rapoza (Santa Clara, USA), LINC Course Director Dierk Scheinert on the 30-day results from the ESPRIT I study, which is ESPRIT I: a clinical evaluation of the Abbott Vascular ESPRIT BVS (Bioresorbable Vascular Scaffold) system. 4 After summarising the components of the ESPRIT BVS system, Professor Scheinert set out the ESPRIT trial design (see Figure 5). It is a prospective, single-arm, multicentre trial in which a single 6.0 x 58mm Esprit BVS is used to treat a single de novo lesion in the SFA or iliac arteries in patients with symptomatic claudication (Rutherford Becker Category 1 3). The objective of the trial is to assess the safe- Continued on page 48 Angiographic and duplex ultrasound results show widely patent arteries after the procedure, which was sustained to one month. Dierk Scheinert (Leipzig, Germany) 47

48 When evolution becomes revolution in iliac and SFA les Figure 5. ESPRIT 1 trial design Continued from page 47 ty and performance of the Esprit BVS in subjects with symptomatic atherosclerotic disease of the SFA or iliac arteries, and the endpoints are procedural, clinical, functional, haemodynamic, angiographic, intravascular ultrasound and noninvasive imaging in-hospital at one-, six- and 12-month follow-up, and at two and three years. After setting out the key inclusion and exclusion criteria, Professor Scheinert said that 35 patients have been enrolled at seven sites, with an average age of 65.3 years. In all, 77.1% of patients are male, 24.1% have a family history of coronary artery disease, 25.7% have diabetes, 85.7% have dyslipidemia, 71.4% have hypertension and 82.9% have a history of smoking. Of the lesions, 11.4% are in the external iliac artery, and 88.6% in the SFA. The target lesion length is 35.5mm, 22.9% have total occlusions, and the average occlusion length is 30.6mm. From pre- to post-procedure, the insegment reference vessel diameter remained at 4.9mm, the insegment minimum lumen diameter increased from 1.0mm to 4.3mm, and the percentage of the insegment diameter that was stenotic reduced from 80.0% to 13.1%. Professor Scheinert then showed angiographic images from a 66-year-old male patient showing excellent outcomes with stent placement (see Figure 6). Professor Scheinert emphasised that there were no deaths and no amputations of the treated limb. There was no bypass surgery of the treated limb, no scaffold thrombosis, no TLR, no target vessel revascularisation, no target extremity revascularisation, and no binary restenosis. The proportion of patients in Rutherford class Figure 6. Angiographic results in a 66-year-old male 0 increased from 0% at baseline to 84.9% at 30 days, while the proportion of those in Rutherford class 3 decreased from 57.1% to 0% over the same time period. Professor Scheinert concluded by saying that there were no clinical endpoint events or scaffold thrombosis observed out to 30 48

49 ion management days, and there was 100% acute procedural success. Furthermore, he said that angiographic and duplex ultrasound results show widely patent arteries after the procedure, which was sustained to one month, adding that there were no indicators of acute scaffold recoil on angiography, and no binary restenosis on duplex at 30 days. There was also substantial improvement in functional status. References 1. Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG; TASC II Working Group. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). TASC II. J Vasc Surgery 2007; 45: S1 S ClinicalTrials.gov. Trial to Evaluate the Safety & Efficacy of the Absolute Pro Peripheral Self-Expanding Stent System in Subjects With Atherosclerotic de Novo or Restenotic Lesions in the Native Common Iliac Artery and/or Native External Iliac Artery. (MOBILITY AP). clinicaltrials.gov/ct2/show/nct [Accessed 5 Mar 2013] 3. ClinicalTrials.gov. Trial to Evaluate the Safety & Efficacy of the Omnilink Elite Peripheral Balloon-Expandable Stent System in Subjects With Atherosclerotic de Novo or Restenotic Lesions in the Native Common Iliac Artery and/or Native External Iliac Artery (MOBILITY OE). clinicaltrials.gov/ct2/show/nct [Accessed 5 Mar 2013] 4. ClinicalTrials.gov. ESPRIT I: A Clinical Evaluation of the Abbott Vascular ESPRIT BVS (Bioresorbable Vascular Scaffold) System. NCT [Accessed 5 Mar 2013]. Positive ESPRIT I Clinical Trial Data Presented at Leipzig Interventional Course Meeting Positive clinical data from the ESPRIT I clinical trial were presented by Prof. Dierk Scheinert, chairman of the Center for Vascular Medicine at Park Hospital in Leipzig, Germany, at the Leipzig Interventional Course (LINC) meeting held Jan The ESPRIT I single-arm, multi-center clinical trial was designed to evaluate the safety and performance of Abbott s Esprit* bioresorbable vascular scaffold (BVS) in patients with blockages in the superficial femoral arteries (SFA) and iliac arteries that result in claudication (leg pain upon walking). The principal investigator of the ESPRIT I trial is Johannes Lammer, M.D., professor of radiology at the Medical University of Vienna, Austria. There were no clinical endpoint events or scaffold thrombosis observed at 30 days. Patients participating in the trial will undergo hemodynamic (blood movement) functional and quality-of-life follow-up at one, six and 12 months and at two and three years following the procedure. Claudication is the most common symptom of peripheral artery disease (PAD), and is associated with diminished physical activity and poor quality of life for patients. PAD is caused by the buildup of fatty deposits in the blood vessels of the leg, which can lead to poor blood flow and circulation. PAD affects nearly 27 million people in Europe and North America and increases a patient s risk of death, heart attacks, stroke, and in some severe cases, amputation of diseased limbs. *Esprit BVS is currently in development at Abbott Vascular. Not CE marked or available for sale.

50 To refine and define our practice the MOTHER regist Recent findings may well change the way we approach TEVAR, particularly with regards to long-term patient survival, chronic aortic dissection and the treatment of the left subclavian artery during the procedure. Together with Medtronic (Minneapolis, Minnesota, USA), Matt Thompson s group at St George s Vascular Institute (London, UK) have created the exemplary MOTHER (Medtronic Thoracic Endovascular Registry) database in order to address the unknowns in best practice for different patient subtypes undergoing thoracic endovascular aortic repair (TEVAR). Evidence-based medicine relies on understanding how different patients need to be treated, but smaller registries may be insufficient to answer all of the important questions. Speaking about these issues in thoracic endografting on Friday at LINC as part of the symposium From clinical evidence to clinical practice new concepts for EVAR and TEVAR, Dr Thompson said: It s largely still dominated by single centre series, which report heterogeneous patient groups with all pathologies mixed in. And that s a problem, because it doesn t allow us to do any subgroup analysis to try and define which patients derive the most benefit, and we have relatively little data about long-term outcome. The MOTHER registry comprises over 1,000 TEVAR patients, including 670 treated for thoracic aneurysms, 195 chronic dissections and 114 acute complicated dissections, facilitating both longitudinal and subgroup analysis. Noting that comorbidities are much higher in patients with thoracic aneurysms, Dr Thompson briefly described the 30 day outcomes: Essentially they mirror outcomes you see in the literature, with death rates at about 5% for thoracic aneurysms, 3% for chronic dissections, and about 10 11% for acute complicated type B in the emergency setting. Moving on to long term data (see Figure 1), Dr Thompson highlighted the need to address long term comorbidities in aneurysm patients, and perhaps to treat them more aggressively. He said: Around 40% of patients with aneurysms die of diseases unrelated to their aorta at five years, and I think this has quite significant implications for our practice. Quite clearly this is because the patients with aneurysms have higher rates of comorbidity than patients with Figure 1a and b: All-cause and non-aortic related mortality in thoracic aortic aneurysm (TAA), type B acute (B-AD) and chronic dissections (B-CD) dissections. They are younger. There is significantly higher allcause mortality in the aneurysm group, all related to non-aortic conditions. If you look at medical risk factors, these patients are grossly under-treated. In this series, less than 50% of patients are on a statin or a beta-blocker. I think this does have implications for patient selection, and it may well be that we should consider treating patients with aneurysms at higher diameters than those with dissections, because they are unlikely to live as long. Dr Thompson then addressed the controversy surrounding the treatment of chronic dissections. If you look at open series of patients having open surgery for chronic dissections, they have relatively high initial mortality and they have very stable aortic disease after ressection. There is a long-term, good freedom from distal aorticrelated reintervention in open series, he said. For endovascular methods, the MOTHER registry results confirmed the relatively high rate of reintervention, but not of aortic-related mortality following ressection at five years. Dr Thompson concluded: Clearly, our challenge here is to get our technique and our technology sorted to try and reduce reintervention. But we are being very effective in preventing aortic-related deaths. Dealing with the subclavian artery during thoracic endograft is a controversial matter, and existing guidelines are clear in expressing this. The SVS [Society for Vascular Surgery] does recommend revascularisation in elective cases, but essentially you need to make an individualised decision, said Dr Thompson. Data from the MOTHER registry includes 322 patients who had their subclavian artery covered and not revascularised, compared to 143 who had a bypass before TEVAR over the subclavian artery. If you look at the stroke rates 9% in the covered group versus 5% in the revascularised group, continued Dr Thompson. However, that doesn t tell the entire story, because with this size of database you can start to do subgroup analysis. If you split the patients into aneurysms and dissections, there is relatively little difference in stroke rate in patients that have their subclavian covered or covered and revascularised in patients with dissections. Virtually all of the difference is in the patients with aneurysms. So patients with aneurysms get much more benefit from revascularising their subclavian than those with dissections. The distribution of strokes in the anterior and posterior circulation is affected by the treatment of the subclavian, with anterior stroke 50 Collating large evidence bases to allow us to stratify our practice and actually making sure we give the right patients the correct treatment is invaluable. Matt Thompson (London, UK)

51 ry rates not significantly affected by whether or not the subclavian is covered. Dr Thompson continued: It is the difference, however, in posterior strokes that is really quite stark in this analysis. If you cover the subclavian artery, your rate of posterior stroke goes up to 3.5%. It is well under 1% if you revascularise the subclavian. So I think that gives us a steer on what we should be doing to the subclavian artery in subgroups of patients. I think that patients with aneurysms look as if they derive benefit from subclavian artery revascularisation prior to TEVAR, concluded Dr Thompson. It is particularly effective in preventing posterior strokes. I think that the pathology that patients present with is very important, and actually should guide our decision-making, because patients with aneurysms have a far higher attrition rate than those with dissections. Finally, I think we can say from this registry that endovascular therapy is an effective treatment for chronic aortic dissection. IN.PACT Data Converts DEB Clinical Promise into Proof Medtronic continues to deliver promising evidence with its IN.PACT drug-eluting balloons (DEB) and progress in its clinical program. The Company recently announced the completion of enrollment of IN.PACT SFA II, the US arm of its FDA Pivotal study. Additionally, with the PACIFIER study published in December, the body of existing clinical evidence has reached a tipping point, with multiple studies now showing how IN.PACT drug-eluting balloons are advancing the treatment of peripheral arterial disease (PAD). Findings from PACIFIER were published in the December 2012 issue of Circulation: Cardiovascular Interventions. This randomized, multi-center, corelab adjudicated study demonstrated a statistically significant improvement for IN.PACT Pacific in the primary endpoint of reducing late lumen loss as compared to bare balloons ( 0.01mm versus 0.65mm P=0.001). This translated into a clinically relevant benefit with significantly fewer target lesion revascularizations for IN.PACT as compared to bare balloons (7.1% versus 27.9%, P=0.02). In addition, Dr. Andrej Schmidt from Park Hospital Leipzig presented data at LINC 2013 looking at the performance of IN.PACT DEB in long SFA lesions. In 288 limbs with an average lesion length of 24cm, IN.PACT achieved a 12 month Freedom from Target Lesion Revascularization rate of 85.0% and a 12 month Primary Patency rate of 77.6%. IN.PACT DEBs are coated with a formulation of paclitaxel and urea a naturally occurring excipient that provides efficient drug transfer to the vessel wall upon balloon inflation. This proprietary coating, known as FreePac, provides stability and uniform application. Medtronic is leading the way in evidence generation for Peripheral DEBs with its IN.PACT clinical program that includes 29 ongoing trials studying over 4,600 patients.

52 Dealing with complex occlusions of the left common ilia A fascinating live case of occlusion of the left common iliac artery that allowed the operators and discussants to focus on the issues and complications that can occur, and the ways in which they can be dealt with in real time, featured during the first session in Main Arena 1 on Friday morning. After a short introduction by LINC 2013 Course Direct Dierk Scheinert (Leipzig, Germany), the session went straight to the live case transmission from Leipzig, with Matthias Ulrich as the lead operator. Dr Ulrich explained that it was a challenging case that was changed from the intended patient in the Guide to Live Case Transmissions to a case of iliac occlusion of the left side. The occlusion was of the common external iliac artery and relatively long. Johannes Schuster, who was in the cath lab with Dr Ulrich, introduced the patient, who was male and aged 68 years. The patient had arterial hypertension, was a current smoker and had peripheral arterial occlusive disease at Rutherford class 3. The patient s walking capacity was 100 metres, and he had claudication in the left thigh. His right ankle/brachial index was 0.7, and he had occlusion of the left subclavian artery. The team from Leipzig then showed the angiogram from the left occluded iliac. Primary access for such a lesion would be transbrachial access, Dr Ulrich said. I like to go from the left brachial artery, as I have the feeling that I have a little bit more support with the sheath. He noted that it is also possible to approach from the right side. Switching to the live images, Dr Ulrich showed how he did the access. Using a long pigtail catheter from the right arm, the team rotated through the descending aorta, and then used a soft angled Terumo (Tokyo, Japan) wire to engage into the descending aorta. They then performed another angiogram. Dr Ulrich said that it feels as if there is a small channel in the proximal segment, and a little calcium. He said: So, the question is: Is this a big calcium chunk, or it is maybe calcium and thrombus? So far, I believe that we still have some thrombus here. The symptoms of the patient have been ongoing for two years and they were no worse in this time. He continued: I was relatively sure that it would not be easy to cross this lesion, so that s why I decided to go in with the 7 French sheath. It gives me a little bit more support and push from the arm over a stiff wire. This is a Cook Medical (Bloomington, Indiana, USA) 7 French 90cm sheath, and if you are careful you can advance over the stiff wire. In the aorta, I pushed in a 5 French sheath in the left common femoral artery roadmap guided and gave a little bit of an injection to check the position. The J-tipped wire is still a little bit in the lesion, which was really easy, and I also have the feeling that there is some thrombus. At this point, Professor Scheinert commented: I think you have raised a lot of interesting points I think what you mentioned here in the case of an iliac or aorto-iliac occlusion highlights that it s important to always figure out whether it is a recent-onset or a chronic history. I think that s really one of the key aspects. As you show, you can never be absolutely sure. Here the calcium is, I think, a clear indicator that there is a chronic process, but it doesn t necessarily mean that there will be thrombus. Typically, what s very important is to ask about a recent deterioration of symptoms, but you said that this was not the case. Professor Scheinert went on to propose two voting questions to the audience, starting with one on interventional therapy in TransAtlantic Society Consensus (TASC) lesions, as the current case is a TASC D lesion, with long occlusion of the left common and external iliac arteries. He said: So the question is: When would you consider interventional therapy? Only for TASC A lesions, A & B lesions, or also for TASC C & D lesions? When the results flashed up on the screen, Professor Scheinert quipped: Koen, we don t need your lecture any more! Session co-chair Koen Deloose (Dendermonde, Belgium), who was due to give a presentation on real life experience and long term data in iliac stenting (see page 46) replied: I am very happy that people are already convinced to use first a endovascular approach in all kinds of iliac lesions! Professor Scheinert qualified: At least there is a strong majority: two-thirds of attendees would consider an interventional approach, for TASC C and D lesions, at least in this case. And one third was reserving intervention for TASC A & B lesions. I think that s quite representative view, probably. Next, Professor Scheinert wanted to consider another aspect of the case by posing a question about how attendees would perform brachial access. He asked: Which approach would you prefer: antegrade recanalisation from a brachial access; retrograde recanalisation and, in case of intimal passage, the potential use of a re-entry system; or maybe a combined antegrade/ retrograde access, as we can see here in this case. When the votes came in, which showed a lack of consensus over the preferred approach, Dr Deloose commented: You see the results of the votes are really translating the doubts and the different approaches of lesions like this, even in experienced centres. It s not clear also to my knowledge, and in literature, what, in fact, is the best approach for lesions like this. Is it antegrade, is it retrograde, or is combined? When I have a lesion like this, in our centre, I start first from a contralateral groin approach, and so try to recanalise the left iliac in an antegrade way, and if I am not successful, I switch to a brachial approach to have more support, or an ipsilateral retrograde approach. Professor Scheinert commented: Yes, but at the end of the day, what we have in common with our approaches is that we try to come 52 I like to go from the left brachial artery, as I have the feeling that I have a little bit more support with the sheath. Matthias Ulrich (Leipzig, Germany)

53 c artery Live case transmission from above. At least that s our concept because we feel that, if we come from above, we are, from the beginning, in a good position in the aorta iliac bifurcation, and then its probably easier to find the solution further distal and terms of re-entry. He added: Matthias [Ulrich], maybe you can tell us why are you actually going both from antegrade and from retrograde? I didn t quite get this story. Dr Ulrich replied: There can be two reasons for this. If we have a difficult, calcified lesion, sometimes it s necessary also to come retrograde. Also, when we want to try to avoid over-extending the circumflex artery, which reaches directly in the distal connection point, to be sure not to dissect too deep into the, let s say, common femoral artery, you can therefore also use the retrograde approach. But primarily I use, in most of the lesions, the antegrade approach from the arm. Professor Scheinert them asked: What type of wires do you have currently in place? Dr Ulrich said: There are connect wires they are 18 inch soft wires, and they give me a little bit better feeling for the lesions. For example, at the end, I am not completely sure now if this is really a stenotic lesion, or is it more thrombus, so that s the reason in this case for coming in a retrograde way. I am expecting that, if I cross very easily with the wire, maybe it s thrombus in the lesion, but because I have the wire backwards Matthias Ulrich speaking at LINC then it would be much easier later if I want to use a Rotarex [Straub Medical, Wangs, Switzerland] wire or something like this. That s why I am careful and going primarily in a retrograde way. Dr Deloose then said: Another question, Matthias: Why a 7 French sheath through a brachial access? Okay, so it s a male patient, but we know out of our experience that in thin female patients a 7 French for a brachial approach is quite big. Probably you can restrict it up to a 4 French long fortress sheath, just to make the recanalisation, and then have a bigger sheath in your left groin, and when the recanalisation is done, you can implant all your stent devices from the ipsilateral groin. Dr Ulrich replied: Yes, you are right, normally I would start with a 6 French sheath, which gives normally enough support, but this is a strong guy, therefore a 7 French would not be a problem, and because I am coming from the right brachial access and we have a more type B aortic arch, which was a little bit difficult to cross, therefore I had the feeling to have a little bit more access with a 7 French sheath. Normally I would come with 6 French. But now, as it was easy to cross the wires in a retrograde way What do you think: Is it thrombus, thrombus and stenosis or? Continued on page 60 If we have a difficult, calcified lesion, sometimes it s necessary also to come retrograde. Matthias Ulrich (Leipzig, Germany) 53

54 LINC A light-hearted tussle over serious matters: CEA versus CAS Once more bearing the mantel of dedication to innovation and patient care, the CX@LINC collaboration rekindled a number of longstanding debates within the interventional arena. Various speakers wrangling over the topic of carotid artery stenting (CAS) versus carotid endarterectomy (CEA) in lively discussions that took place on Thursday afternoon, chaired by Roger Greenhalgh (London, UK.) Sri Iyer (New York, USA) lit the first fuse, taking the side of carotid stenting. If you look back at the publication in Circulation in , we first reported our two-year experience from UAB [University of Alabama at Birmingham, Alabama, USA], where 107 patients were treated with carotid angioplasty, he began. We did not have the benefit of embolic protection, and no dual anti-platelet treatment, but stents were used in the vast majority of them. 50% of patients were referred by vascular or neural surgeons, so by definition they were high surgical risk. Stroke and mortality in that series was 7.9%, major stroke and death was 1.9%. If you look at the 30-day outcomes for all of the high surgical risk patients who underwent carotid stenting since 2000, you can see that, beginning in 2000, the 30- day composite of death, stroke and MI [myocardial infarction] was about 8.5%. Gradually, it has come down over the next decade or so. Explaining this phenomenon, Dr Iyer said: We fundamentally failed to recognise that high endarterectomy risk is not the same as high stent risk. In the beginning, we obviously had to take over whatever the surgeons could not do and apply stents indiscriminately to all of these patients, which explains why we had such high risk. Addressing the question of durability, he continued: Surgeons are very fond of saying, There is no data to suggest that carotid stenting, like endarterectomy, can prevent stroke what about restenosis? Neither of these are clinically important events: restenosis is in the low single digits, and most (if not all) of these patients are asymptomatic, despite being a superficial structure, there is a very low incidence of stent fractures. There is clinical durability, because we have demonstrated, like others, stroke-free survival in longitudinal follow-up. Summarising his argument, Dr Iyer concluded: The key to risk reduction is to use optimal techniques, technologies, medications, and recognise what is high stent risk. Frank Veith (New York, USA) then inspected a variety of guidelines in use for the treatment of carotid stenosis, posing the question as to how such differing interpretations be drawn from the same data. He said: In 2011, three guidelines were published on extra-cranial carotid disease. One was the AHA [American Heart Association] guideline, another was the SVS [Society for Vascular Surgery] guideline, and the third was the European Society for Cardiology [ESC] guidelines. The AHA guideline is the most popular and best-known, and it was supported by another 13 institutions in addition to the AHA. In 2011, there were two other guidelines published on CAS: One was the Australasian SVS guidelines and the other is the NICE [National Institute for Health and Clinical Excellence] guidelines from the UK. All five guidelines use the same data and trials, and yet all came to different conclusions how could this happen? Describing the discrepancies between the various associations, he said: The AHA guidelines showed that CAS is an alternative to CEA; the SVS and Australasian guidelines showed that CEA was the treatment of choice and similarly, the ESC guidelines showed the same thing. With asymptomatic patients, the AHA guidelines showed that CAS may be considered, although it was a weak recommendation. The ESC guidelines said that, in centres with low stroke rate, it was okay to do CAS. The other guidelines had insufficient evidence to make any conclusion. Dr Veith proposed that interpretive bias may explain these difference. The AHA guidelines were based primarily on CREST [Carotid Revascularization Endarterectomy vs. Stenting Trial] 2. You all know the famous article in the New England Journal [of Medicine] that said there was no difference in CAS and CEA in the primary endpoint and no difference based on symptom status or sex. Detailing the major findings of the CREST study that would explain this bias, Dr Veith showed how CAS and CEA are not as equal as the published work originally concluded: CAS-treated patients had twice the incidence of death, total strokes, major stroke and minor stroke than did the CEA patients. Only when minor MIs were added did the total adverse event rate become equal Are the two procedures equal? Dr Veith pointed out that subsequent and ancillary CREST publications have since indicated larger discrepancies in risk in both gender and adverse events. My conclusion is that there is disagreement within the five most recently published guidelines, with the AHA guidelines as an outlier, he said. You can ask the question fairly: did bias have an effect? Ongoing and future improvements in CAS may change things, but trials must prove it. My current conclusions: the SVS and Australasian guidelines are most appropriate at present; CEA is best for most 54 Surgery is robust. Peter Taylor (London, UK)

55 symptomatic patients; and many if not most asymptomatic patients should be treated medically. Also focussing his attentions on CREST was William Gray (New York, USA), drawing a fine-toothed comb through the time-course of the study. He showed that stenting risk was reduced throughout the study duration, a phenomenon he put down to operator experience. By the end of the trial, major stroke and death were zero in both the symptomatic and octogenerian population, he said. This is because, if we look in the United States where this trial was performed in the main, we see that the second half of this trial was coincident with a very large increase in experience of carotid stenting. Dr Gray suggested that FDA (Food and Drug Administration) and CMS (Centers for Medicare & Medicaid Services) approval led the way for this improvement. Painting plainly his conclusions from the CREST trial, Dr Gray said: There is no difference in symptomatic and asymptomatic patients between stenting and surgery period. It is the end of the conclusion of the trial. If we look at target lesion revascularisation [TLR] in CREST no difference. Outcomes in CREST between asymptomatic and symptomatic there is absolutely no difference between the primary endpoint of death, stroke and MI. Frank [Veith], I would like to say that minor MIs are the difference between the therapies, but in fact there is no such thing as a mild MI as CREST pointed out. He went on to say that, although there were differences in minor stroke incidence between CAS and CEA, at six months there was no differences in functional capacity. In contrast, MIs had a marked outcome effect, with a quarter of patients dying within four years of MI of any variety. Regarding nuisance events, he said: Cranial nerve injury was persistent in 2% of patients. Access site complications were eight times more frequent in surgery versus stenting. If we look at cost and patient preferences, we see that quality of life was different. Nobody liked major stroke. Minor stroke not so bad. MI not so bad. If we look at the quality of life of surgery versus stenting, stenting wins at two weeks, 30 days, with no difference at one year. At the end, the advantage actually goes to carotid stenting. I find it difficult to randomise a patient who is asymptomatic to surgery when I know that there is an adjunct problem with surgery (cranial nerve, access bleeding and so on) when stroke and death is no different. Michel Makaroun s (Pennsyl- Continued on page 56 Operators (% ) Operator experience and carotid stenting outcomes in Medicare beneficiaries CREST CAS patients 24,701 Medicare CAS from Median operator volume Volume <6/year Volume >24/year 0.7% mortality 1.9% mortality Real-world mortality 2.7 x higher than CREST 3 CAS/year Mortality 2.5% Mortality 1.4% Annual operator volume, procedures/y Nallamothu BK, Gurm HS, Ting HH, et al. JAMA 2011;306: Figure 1. CREST results in Medicare beneficiaries Do not miss LINC@CX during the 35th CX International Symposium Sunday 7 April, 2013 Advanced revascularization concepts for complex peripheral obstructions Chairmen: G. Biamino and M. Bosiers Pioneering techniques for limb salvage in challenging BTK-cases Chairmen: I. Baumgartner, D. Scheinert

56 LINC Continued from page 55 vania, USA) rebuttle followed, in which he reasoned that CAS may be as good as CEA in some patients, but that it certainly does not mark it out as the better of the two. If your only tool is a hammer, you end up chasing every nail around, he quipped, adding: I was both a surgeon and an interventionalist in CREST, so you know you can trust me and not Willims Gray! Outlining his issues with the CREST study, he said: MI is probably not an appropriate primary endpoint, because when you choose a combined endpoint, you should probably have endpoints that are equivalent in severity. If you take out MI, you clearly have a significant advantage in the CEA arm, both in the symptomatic and the total. Dr Makaroun also pointed out the significant deviation from the assigned treatments during the CREST trial, which may have skewed results or even improved the outcomes in the CAS cohort. Nearly 10% of patients assigned to stenting did not actually get stenting, and 58% of those has CEA. The fourth point is, are the [CREST findings] real-world? And the answer is no. He noted that studies based on Medicare results in the US showed that mortality is nearly three times higher in CAS (see Figure 1). Experience, while related to the outcome, is nevertheless very limited in the majority of real-world cases. You have heard the claim that CAS results got better over time, Dr Makaroun continued. But actually what truly happened is that there were much fewer symptomatic patients, and much younger cohorts that were included. If you correct for those, there is no difference in the first, second or third time period. In a biting conclusion, Dr Makaroun outlined the patients he would consider appropriate for CAS: If you look at age, clearly anybody over the age of 65 or 69 depending on which endpoint you choose to believe should not have CAS. If you look at women, you will also notice that the women do worse with CAS compared to CEA. When you look at the symptomatic versus asymptomatic patients, you notice that symptomatic don t do as well with CAS. So we are only left with asymptomatic young men. So clearly, CREST puts CAS ahead only for cardiologists. Peter Gaines (Sheffield, UK) sidestepped the hubbub of data with a measured approach, attempting to show that a decision should be made based on the fact that stenting is performed differently in different parts of the world. Training and case selection form the key to success, he said. Some things are just obvious, and I m going to obviously point out the obvious. Describing the many factors involved in a successful procedural outcome, Dr Gaines said: We ve learned a lot over the last few years on who does well in CAS. You really don t have to start your own program without training to learn the lessons of history. We have learned how to choose patients well. We have learned that timing of intervention affects outcomes. Duel anti-platelets are absolutely essential. Technique is important, and you need to be able to manage your complications. If you can learn all of that ahead of time, then you ve done your patient a good service, rather than just starting without training. But, as Dr Gaines pointed out, training is very different from experience. Although outcomes do Figure 2. Benefits of a two-day CAS training course Van Herzeele, Aggarawal, Darzi, Cheshire, Gaines, EJVES 2008;35: indeed improve with experience, he said that training cuts short the learning curve in CAS (see Figure 2). Without training, operators would always start out performing poorly. Drawing a parallel with laparoscopic surgery, which has seen drastic improvements in outcomes due to formal training in the US, he concluded: If that s true of laparoscopic surgery, it s true for interventional staff as well. If you wish to perform carotid stenting, get trained! Peter Taylor (London, UK) fought Continued on page If you wish to perform carotid stenting, get trained! Peter Gaines (Sheffield, UK)

57 Header Do not miss During the 35th CX International Symposium Sunday 7 April, :30 Advanced revascularization concepts for complex peripheral obstructions Chairmen: G. Biamino, M. Bosiers Moderators: A. Schwindt, J. van den Berg, P. Schneider Live case transmission Recanalization techniques and outcomes of stentsupported reconstruction of complex aortoiliac obstructions M. Bosiers The benefits of low-profile devices in challenging access situations A. Schwindt Live case transmission DEB vs. DES vs. bare nitinol stents for treatment of femoro-popliteal lesions How to choose the best treatment modality D. Scheinert Live case transmission Versatility of GORE VIABAHN Endoprosthesis in treating vascular disease M. Steinbauer Live case transmission Pioneering techniques for limb salvage in challenging BTK-cases Chairmen: I. Baumgartner, D. Scheinert Moderators: Th. Zeller, M. Werner, K. Deloose Live case transmission Extreme interventions in BTK Advanced access and crossing techniques A. Schmidt Guide-wire selection for challenging CTOs and everyday lesions I. Baumgartner Live case transmission Interventional options in common femoral and popliteal artery lesions Th. Zeller Optimal solutions for the popliteal artery M. Werner Live case transmission All live cases will be broadcasted from the Centre of Vascular Medicine at the Park Hospital Leipzig, Germany. Operators will be: Prof. Dierk Scheinert, Dr. Andrej Schmidt, Dr. Sven Bräunlich, Dr. Matthias Ulrich, Dr. Johannes Schuster 57

58 LINC: Addressing myths in carotid artery disease For over two decades, Transcatheter Cardiovascular Therapeutics (TCT) has been at the forefront of live cardiovascular teaching worldwide. It has a strong focus that incorporates cuttingedge interventional approaches, technologies and advances into a solid breakdown of the current scientific evidence. As a new venture for 2013, LINC and TCT joined forces to bring a variety of cutting-edge sessions that would combine knowledge and expertise from both internationally-renowned meetings. First was a selection of Deep Dive sessions on carotid intervention and renal denervation, filled with live cases, panel discussions and device parades. The core LINC session, hosted on Friday, put the spotlight on controversial issues and new insights for carotid revascularisation, with experts lining up to deliver their latest insights into matching carotid vascular anatomy with the appropriate revascularisation strategies and techniques; whether medical treatment alone is the best strategy for all symptomatic carotid artery stenosis; large clinical trial results and their implication on decision making; and the myths of carotid stenting. A selection of live case transmissions from Hamburg and Leipzig was also a key component. As Co-Director of TCT, and Chair of the session, William Gray (New York, USA) described this new partnership and what teaching points it covered on its first outing. LINC has really been a significant presence in the practical nature, know-how and how-to perspectives of peripheral intervention, and while that s part and parcel of TCT as well, we focus more on data sets that are available, to try and understand better the outcomes related not just to single centres but multi centres, said Dr Gray. At TCT last year, LINC had a very nice session on the practical aspects of interventional techniques, and TCT is brings analytic and comparative-centric presentations to the fore in return. As well as chairing the session, Dr Gray gave a presentation to set the record straight with regards to myths in carotid stenting. The first myth that Dr Gray introduced was the notion that carotid stenting is more expensive than carotid endarterectomy: In fact that s not true there are several papers that have looked at the charges, retrospectively, and found that these charges unfortunately have very little bearing with respect to actual cost of the procedure, he said. Delving deeper, Dr Gray added that this was largely due to the way in which the economic system is structured, especially in the United States, leading to a disparity in how costs are proportioned for each procedure. Looking at the prospective data sets for coronary stenting, we find that there are, in fact, no differences in cost between stenting and surgery, and that s true both at the time of hospitalisation and at one year, he said. The second myth would be that there are differences in terms of outcomes between endarterectomy and stenting. But in fact the largest most rigorous prospective study shows no difference between the two for stroke death Figure 1 and myocardial infarction up to four years. With this in mind, Dr Gray stressed that one of the major reasons that there is poor comparison between endarterectomy and stenting in this setting is because many people use databases to compare patients that are simply incomparable. There is a horrible selection bias involved in their analysis, said Dr Gray. 58 Looking at the prospective data sets for coronary stenting we find that there are in fact no differences in cost between stenting and surgery. William Gray (New York, USA)

59 Moreover, there is a bias in ascertainment. In this country, for every carotid stent that is reported in the literature, there s a neurologist that sees the patient before and after the procedure. That s because in order for hospitals to get paid, patients have to be in a registry, and that registry mandates the neurological oversight. These neurologic reports are sent for independent adjudication, and then the reimbursement can be processed for the hospital. Crucially, however, endarterectomy remains outside of this system (i.e. it not easy to retrieve costs), thus there is a knock-on effect that sees the majority of high-risk patients in the US treated with stenting. The third point is less of a myth, more of a fact of life, said Dr Gray. Operative volume, as well as time of duration of the procedures, sees greater improvement in limb outcomes in both procedures. So we ve seen in the last years a marked improvement in endarterectomy outcomes. Similarly, concluded Dr Gray, advancements in operator volume, experience and technology has meant that carotid stenting has made a remarkable improvement in recent times as well. Also speaking during the session was Michael Jaff (Boston, USA), who put the question forward as to whether medical treatment alone is really the best solution for all asymptomatic carotid artery disease. Probably one of the most controversial topics right now in all of vascular medicine is when to do an intervention on a patient with carotid disease, specifically asymptomatic carotid disease, he said. The reason for that is that the benefit of intervention for patients with asymptomatic disease over medical therapy is much more narrow than if they had a symptom like a TIA or a previous nondisabling stroke. So that means if the benefits are more narrow then you have less room for error. So if you re going to do an invasive procedure on someone with an asymptomatic carotid stenosis you can t afford too many events or else you completely wipe out the benefit. So that s why it s so controversial. Dr Jaff added that there was also controversy surrounding the type of invasive carotid procedure that should be done, but in his presentation he focused more on the use of medical therapy as a standalone treatment for asymptomatic carotid disease. Carotid artery stenosis that s less than 70% and asymptomatic probably is best treated medically, said Dr Jaff. There are very few reasons one would consider an invasive procedure for asymptomatic, less than 70% carotid stenosis. When carotid stenosis is in the range of 70-80%, more factors come into play to decide whether medical therapy or an invasive procedure should be utilised. A lot of it depends on how healthy the patient is and how skilled physician is performing the procedure, said Dr Jaff. He continued, giving an example for illustration: Let s say a year ago stenosis was less than 50%, and now it s more than 70% in a year. You ve done everything you can to maximally medically treat them. They re on full dose statins, their LDO s controlled, their blood pressure is good, and then they develop a rapid progression. Those are people that most of us would say ought to be considered for an intervention. Dr Jaff added that anyone with a greater than 80% asymptomatic carotid artery stenosis should be treated by a skilled operator. Conversely, patients with less than 70% stenosis would almost certainly always be referred to medical therapy: I don t think too many people debate the less than 70% people, he said. Even the most aggressive of interventionalists accept the fact that it s pretty hard to beat the low stroke risk that occurs with a mild to moderate asymptomatic carotid artery stenosis. Even the most aggressive of interventionalists accept the fact that it s pretty hard to beat the low stroke risk that occurs with a mild to moderate asymptomatic carotid artery stenosis. Michael Jaff (Boston, USA) 59

60 Dealing with complex occlusions of the left common ilia Continued from page 53 Professor Scheinert chipped in at this point: Well, I can tell when I look at your table that you think it s thrombus because you have already the thrombectomy system on the table! Now I also understand why you approached retrogradely, because, if I understand you correctly, with the antegrade testing you got the impression that it is more soft material and you wanted to have a easier access for your thrombectomy system. Is that correct, Matthias? Are you planning to do thrombectomy? Dr Ulrich said: This is exactly my intention. Hopefully it will not end in a perforation, which is sometimes not easy in the iliacs because you have the risk of bleeding. To make it more safe, you could well, to figure out if it s really thrombus, you could also go in at first with a really low profile balloon, but then you also have a higher risk of distal embolisation. The second question is whether we should protect the right side by using the atherectomy device so as not to have a thrombus going all over the bifurcation to the right side. So maybe it s not necessary to use the Rotarex, but after the Rotarex, when I want to do PTA [percutaneous transluminal angioplasty] or I am implanting a stent, maybe it s a good idea to protect also the right side. Dr Deloose commented: Although, you have an important step at the left common iliac, so probably there is it not that big. Here s another question: Is chemical thrombolysis with urokinase or rtpa [recombinant tissue plasminogen activator] here an option, just to put thrombolysis catheter in for like 12 or 24 hours and then check it tomorrow morning, for instance? Replying, Dr Ulrich said: Primarily, I think it s more successful to do it in a mechanical way. Because the patient has had symptoms for two years, I am not sure that the thrombolysis will really work, but you are right that, if I am having problems with the Rotarex or not, to get a really good result afterwards, maybe it could also be good idea to do [chemical thrombolysis] in addition to this. Returning to the patient and attempting to cross the occlusion, Dr Ulrich commented that there was no resistance and that it was really easy to cross. He added: There is a calcium chunk there. Maybe this tells us the truth that there was a stenosis, in this segment and then the rest is thrombosis. Dr Deloose commented: Matthias, this is like in the majority, especially in iliac cases, where you have these complex occlusions consisting of a plaque, with tough, very calcified material, but also some fresh thrombus. So it s always a combined occlusion of different materials. He continued: I also think the first part, the common part, of these complex iliac occlusions is, in fact, a functional occlusion, as we have seen at the beginning of the case in the first images. There was like a very small channel in the proximal part [of the occlusion], and so I think you ve covered the major occlusion in the external and distal common iliac right now with the Rotarex. Dr Ulrich said: Yes, you are right. What I want to do now is to pull back the system and leave the hybrid lesion proximal, and go again so that I will not have not so much. This will maybe make this a bit more clear. Expanding on the use of Rotarex, Dr Deloose asked: So, imagine we are in centres where this Rotarex device is not available, what is the second option? Is it chemical thrombolysis, or are some other thrombus-aspirating catheters available to treat lesions like this? Dr Ulrich commented: Maybe then a surgical approach would be nice. With thrombectomy from the groin, or some kind of hybrid. I think this would be more safe. After discussing these points further, Dr Ulrich said that there was a lot of material in the lesion, so he asked the panel what they thought should be the next steps. Is it safe to go for primary stenting, he wondered. If so, should that be with covered stents or nitinol stents? Dr Deloose commented that it was a great question and also a great debate in the endovascular world. He asked whether the treatment after debulking or thrombus debulking, should really be direct stenting without another pre-pta manoeuvre and, if yes to direct stenting, which type of stents should be used: Nitinol stents, stent grafts, balloon-expandable, self-expandable stents, etc.? After some discussion, the panel concurred over the use of primary stenting. After performing some more passes through the lesion, Ulrich checked the status of the lesion and decided upon the next step. Dr Deloose asked: Do you think there is room here for a balloonexpandable stent? We have seen that, especially the proximal part of the lesion, it is quite heavily calcified, as we see on the fluoroscopy. So, with some more radial force, do you think there is room? Dr Ulricg replied: That is a good question. There are two points: With a balloon expandable stent, you definitely have a high risk of squeezing thrombus out, but on the other hand this looks maybe a little bit more calcified than thrombotic in this area. So I would try to stay more safe in this way. Maybe there is also a good option of putting a long nitinol stent in and, if I have problems, maybe if there is recoil in this proximal segment, then you can put inside an additional bare metal stent. These issues were debates further by the panel, with many of the questions and issues that have arisen over the years from the practical application of stents discussed. After it was agreed that the thrombectomy had achieved about as much as could be expected, Dr Ulrich said he would now implant a bare metal stent proximally to cover the thrombectomised part of the lesion, and then implant a long, nitinol stent in the distal segment. As the first stent was implanted, Dr Ulrich commented that he would normally 60 It s important to always figure out whether it is a recent-onset or a chronic history. I think that s really one of the key aspects. As you show, you can never be absolutely sure. Dierk Scheinert (Leipzig, Germany)

61 c artery Live case transmission now push in the sheath to bring the stent into position safely, but in this case the lesion is soft, so the stent tracked very easily. Dr Deloose noted: One of the advantages of the balloon-expandable stent is that you really can do a pre-size placement, especially when you are treating ostiums, ostial lesions and so on. Maybe you have to take care about contralaterals, but you really can implant it right at the spot where you want to have it. After a discussion, the use of a balloon-expandable stent was agreed by the panel as being right for this location. Dr Ulrich then said about his stent placement: I think this is a nice position. So for the more distal nitinol stent, I think we should oversize or also try to size it size-by-size. There is a higher risk with an oversize nitinol stent of squeezing the thrombus through the struts, however. Dr Deloose chipped in at this point, saying: Also this is a very good question, Matthias. In my experience, we slightly oversize self-expandable nitinol stents independently of the fact that there is a risk of some remaining thrombus or not. However, I am 100% sure that, especially in previous times, we oversized too much. And we noticed that if you oversize too much, you have much more vessel trauma, physical irritation and intimal hyperplasia afterwards. So probably a slight oversizing of 10% maximum is ideal. Performing an angiogram, Dr Ulrich said that he felt that the stent size was okay, with good flow and not much squeezing of the thrombus through the struts. Noting that the vessel looked big distally, he suggested that an 8mm nitinol stent would fit very well. The question is now the length, he continued. Therefore, I would like to measure maybe with a balloon. We have an 8cm balloon here on the table. Dr Deloose commented: It s a male patient, as you said, with a very good brachial artery, so his vascular system is quite acceptable. I think I should implant there an 8mm self-expandable nitinol stent. Absolute Pro [Abbott Vascular, North Chicago, Illinois, USA], for instance. Dr Ulrich replied: Yes, this is my intention. But now I will try to measure a little bit the length. Therefore I go in with a 5x80 balloon, which is still on the table. So it means now this is 8cm. Maybe cm would be nice. So let s check again from here. I ll give a general injection into the sheath in the common femoral artery. Dr Deloose asked the panel: Is there somebody thinking that there is a place for PTA only on this iliac field? Carlo Setacci (Sienna, Italy), who was one of the session moderators, replied: We would have a 100% possibility of recoil. Dr Deloose said: I fully agree. Also, the literature is quite clear on this that stenting does much better than PTA-alone in the iliac field. Dr Deloose continued: Matthias, what about the over-lapping zone. You have a cobalt chromium stent balloon-expandable in the common iliac, now you are going to extend this with a nitinol selfexpandable stent. What about this overlapping zone? Do you expect some problems there, now or in the future? Intimal hyperplasia, restenosis at the overlapping zone? Dr Ulrich said: No, we have never seen such problems. There was always a discussion whether there would be something between the two different materials. We have never seen problems. It s why, if there is a need, I would overlap for a long distance, but I always try to overlap not more than 1cm. But this time I need Continued on page 62 MediFore are the proud publishers of LINC Today and LINC Review We are a full-service medical communications and publishing company, working closely with local and international medical societies and associations, and industry, to develop conference publications, including newsletters and newspapers, as well as reports and medical summaries, medical writing and scientific publications

62 Dealing with complex occlusions Continued from page 61 4cm because the stent is a little bit too long, I would better overlap more and place the stent more exactly distal than having a precise overlap. He added: Now the stent is coming in. Hopefully it s not too short about 15cm would be definitely too long. Maybe we will need a third one, let s see. I would not stretch the stent It would be really easy to stretch the stent now to have this 1cm covered, but we know that this will end up in a higher restenosis rate, and also here I think it will cause there to be less scaffolding for the thrombus if we stretch the struts. Dr Deloose said: I fully agree with you and, especially in the iliac area, it s just better to implant a third stent than just to try to elongate the stent a little bit. This is going to create definitely stent fractures and in-stent restenosis very early. When the panel were able to see the results, Dr Deloose said: Unfortunately you just missed the last part. Dr Ulrich said: Yes, the last 5mm. So, what do you think for the post-ballooning now? This is definitely also now a risk for mobilised thrombus. Shall we do completely without [ballooning]? Dr Deloose said: After your pass with the Rotarex, I am not concerned anymore about big embolisations in this stage of the treatment. Session moderator Yann Gouëffic, St Herblain, France asked: Are you concerned about stent fracture in this zone of mobility? Dr Ulrich said: Not in what we have seen so far. The stents are so flexible and now they really don t have these problems with fractures anymore. Professor Scheinert commented: I think this is a frequently discussed aspect: How far into the common femoral would you be able to stent? I would say, of course, we try always to stay out of this region as much as possible. On the other hand, I think it would be a mistake if there is a flap or there is a residual stenosis not to stent in this region only because of a concern over a fracture. In fact, we have, over the years, and even with earlier devices, never really had systematic issues with it. But we have seen issues if we stayed away from that and left a flap behind, or something like that. So the question is now, Matthias: Are you going to post-dilate this, or are you afraid that you squeeze the thrombus out? Dr Ulrich replied: There is still some thrombus at the tip of the sheath. I cannot aspirate here. Let s go in again with the Rotarex, but it s also a little bit dangerous because it s also the area where I punctured. After returning to the Main Arena for a presentation by Koen Deloose (see Page 46), the panel came back to the case. Dr Ulrich began by stating: It s not solved. It s really difficult to get this chunk out. I did a bit of Rotarex, but this was not successful. Now we are bringing in the sheath from the arm to try to suck something, but it s also difficult to advance the 7 French sheath across the stents. Maybe also a good solution would be to stop here and to have a little cut stop in the groin and pull it out in a surgical way. What do you think about this strategy? Professor Scheinert said: Personally, I think that is quite appealing here, because I get the impression that this thrombosis is also somewhat stuck in between the sheath and if you don t have a lot of space to manoeuvre Well, you could try an aspiration from above, for sure, with a large guiding catheter. If you can catch it, it s good, but if you can t that s actually a good position, and then you don t need to compress, you can leave it to the surgeon. Koen, you are a surgeon, would that be your approach? Dr Deloose said: Yes, in this situation, in this position, there is only one possibility to solve it, and it s a surgical approach. That s the reason it s very nice to show during a live case like this. The biggest complication in my experience of the endovascular iliac treatment is distal embolisation. It s not perforation or other things, but distal embolisation, and when it s really soft to pass, we prefer a chemical thrombolysis over mechanical thrombolysis. Professor Scheinert said: I think it just highlights what apparently was a partially fresh occlusion. You already figured that out, you did the mechanical thrombectomy, but still it s a risk, and Koen s absolutely right that it s a remaining risk in such fresh lesions. Calling for a quick vote by raising hands, Professor Scheinert asked: Who would actually solve that with a small cut-down and a surgical thrombectomy? Who would continue with some sort of aspiration? Noting that more audience members were in favour of continuing with aspiration, Professor Scheinert said: There is still a lot of interventionists who don t like to give up so quickly. He then asked Dr Ulrich what he would do next. Dr Ulrich said: I would go for additional aspiration, but I believe that the approach from the right arm will not reach down because the aspiration catheter is 100mm, the sheath is 90mm and I think that if we could cross this structure we would also not have enough support to come in across the area of the thrombus. So the only thing we can do if we want to do more aspiration is to have a third access at the right groin, coming from across and over. With this approach we could also try to suck a little bit, but then of course the patient has three access points and if we run into a problem and do need thrombolysis afterwards, maybe it would end up with problems. So I think, for the patient, the most safe way at the moment is to have a cut-down. Summarising, Professor Scheinert said: Thank you for this exciting live case. I am sure it was more exciting than you hoped, but this is the beauty of the live cases and I am sure you will find a very good solution for your patient. I think this surgical approach is really safe. 62 In this position, there is only one possibility to solve it, and it s a surgical approach. That s the reason it s very nice to show during a live case like this. Koen Deloose (Dendermonde, Belgium)

63 LINC Continued from page 56 for the CEA corner, citing its consistency in its teaching and safety as a clear advantage. He said: We ve heard a little bit about the problems with stenting an increased risk of stroke, probably caused by distal protection devices, and an increased risk of death. We ve heard from the stenters that the problems with surgery are an increased risk of MI, cranial nerve damage and cervical haematoma. So how do we put all this together? A systemic review and meta-analysis of 13 randomised trials comprising 7,500 patients looked at CAS and CEA in only symptomatic patients. There is an increased risk [in CAS] of any stroke of 1.45, a decreased risk of peri-procedural MI of 0.43 and non-significant increased risk of mortality of 1.4. Addressing the issue of competence that Dr Gaines spoke of, Dr Taylor said: The wonderful thing about CEA is I can teach it to trainees, and when they become consultants they can operate very safely. It has to be said, from the data that s been given and the opinions that have been given, that stenting remains a difficult procedure and good results can only be obtained by experienced experts. Surgery is robust. Dr Taylor was thorough in his patient selection for CAS. Recurrent stenoses, high difficult lesions, hostile necks, stenoses related to radiation, laryngectomy and previous blocked dissection were all good candidates for stenting in his opinion. Who should stent? he posed in conclusion, with the sage answer: Expert interventionalists who understand the problems. They need to work collaboratively with stroke physicians and vascular surgeons. They need regular, careful case selection and regular audit. And if you ask, who should stent? The answer is, not me! Sumaira MacDonald (Newcastle, UK) then addressed the half-way house of hybrid approaches in carotid procedures. I put it to you that supporters of CAS must own Figure 3. First-in-man data from the PROOF trial 1Minor contralateral stroke adjudicated as not device or procedure-related. Pinter L et al JVS 2011;54: (N=44) their complications. Sticking one s head in the sand leaves vulnerable parts prone to attack. Similarly, she made it clear that advocates of surgery must also own their own complications. Those limitations are excess MI risk, cranial nerve injury, haematoma and impact of medical comorbidity on outcome compared to stenting. Endarterectomy, as it was performed by expert surgeons in the tightly prescribed randomised trial of CREST, performing a procedure that has had 60 years to refine itself, incur a procedural hazard called MI that impacts on mortality in four years, she said. While both CAS and CEA naturally have their complications, Dr MacDonald proposed a third avenue of treatment based upon her own studies. The half-way house could be this high flow rate flowreversal system going into a mini cutdown trans-cervical, 2cm above the clavicle, she said, speaking of the MICHI neuroprotection system (Silk Road Medical, Sunnyvale, CA.) Presenting first-in-man data from the PROOF trial 3 (which included 44 patients at the time of publication), Dr MacDonald showed the hybrid system addressed some of the major concerns in both CAS and CEA (see Figure 3). She concluded: The MICHI system has the potential to offer a half-way house, i.e. the best of both worlds, as a hybrid that has the potential to mitigate against the new white lesions that carotid stenting causes, and the MI and cranial nerve injury that we might expect with endarterectomy. Frans Moll (Utrecht, the Netherlands) concluded the debate by dismantling some of the preceding arguments over CREST data. Over 2,500 patients have been included, symptomatic as well as asymptomatic. Primary endpoints of death, stroke and MI, within 30 days in aggregate, is almost the same. But such a simple conclusion would not have warranted a debate at all, as Dr Moll made plain. This is only true when we consider death, stroke and MI as the same, he said. This is not the case according to patients during follow-up using a quality of life SF-36 form. At one year followup, stroke was by far the most disabling. From a patient perspective, at one year follow-up MI was considered a non-event. Considering only stroke and death as endpoints in this way reveals a significant difference in composite rate: 2.3% in CEA and 4.4% in CAS. The four-year mortality rate for patients with an MI was 19.5% versus 6.7% for patients without an MI. But surprise! The four-year mortality rate for patients with a stroke was 20% versus 11.6% in patients without a stroke. In conclusion, the four year survival for CEA surgery and CAS was the same, but CAS patients had a increased disability due to a significantly higher stroke rate. In women, this was even more dramatic. In this whole debate, surgeons are capable of handling carotid endarterectomy, and in the future also stenting. References 1. Yadav JS, Roubin GS, Iyer S, et al. Elective Stenting of the Extracranial Carotid Arteries. Circulation 1997;95: Brott TG, Hobson RW, Howard G, et al. Stenting versus Endarterectomy for Treatment of Carotid-Artery Stenosis. N Engl J Med 2010;363: Pinter L, Ribo M, Loh C, et al. Safety and feasibility of a novel transcervical access neuroprotection system for carotid artery stenting in the PROOF Study. J Vasc Surg 2011;54: In this whole debate, surgeons are capable of handling carotid endarterectomy, and in the future also stenting. Frans Moll (Utrecht, the Netherlands) 63

64 Collaborations at LINC: VIVA Continued from page 13 patient who was a good candidate for a bypass, said Dr Schneider. As such, as new CTO devices have been developed, Dr Schneider s practice has seen the number of bypasses performed diminish significantly: The new re-entry devices have really complemented what we can do and what we can offer for a long occlusion when we are taking an endoluminal approach, he said. Of course, a factor that influences the timeframes for approval of most if not all devices is whether the market being considered is Europe or the US. This is just as true for CTO devices, but Dr Schneider noted that approval still needs to be followed with hands on experience: Europeans will typically have all these devices before the US, but they may not have had a chance to have that technology dispersed into the community, depending on the areas of expertise within any specific community, he said. Within his talk in the session, Dr Schneider summarised the experience levels now obtained with these devices, emphasising that, more than anything, although the experience is pretty good with the devices that have been out there for a while, people are still anxious to try the new devices. We re imagining that some of the newer devices will be complementary, and we also have a high level of interest in their continued development, because as I mentioned the flip side of the equation is that we typically use these devices in patients who have occlusions which are recalcitrant to standard techniques, angiographic catheters and available guidewires, he said. Dr Schneider continued by adding that one could argue that different specialists will have different opinions as to the extent that these new CTO devices are needed. For example, he relayed that it would appear some interventionalists believe they can cross most occlusions with a simple catheter and a wire which, although possible in the majority of patients, is still difficult in the significant number of calcified or very long occlusions which occur, leading to poor control over a catheter and wire during recanalisation. These are very often the precise patients in whom we are not very interested in doing a bypass: patients with heavy calcium and long occlusions that may have other Figure 2: CTO Devices are changing the game Advance Purpose Examples CTO support catheters Support during wire crossing CXI (Cook) Quickcross (Spectranetics) Trailblazer (Covidien) Gopher (Vascualr Solutions) Distal Access Acces for bi-directional approach Retrograde puncture of SFApopliteal Tibeal-pedal Re-entry catheters Enter true lumen from subintimal Outback (Cordis) Pioneer (Medtronic) Enteer (Covidian) Offroad (Boston Scientific) CTO crossing devices True lumen crossing Crosser (Bard) Frontrrunner (Cordis) Laser (Spectranetics) TruePath (Boston Scientific) Wildcat (Avinger) Viance (Covidien) major medical problems, so that s where the re-entry devices come in, said Dr Schneider. In his conclusion during the session, Dr Schneider re-emphasised that new tools are changing the game, including CTO support catheters, distal access methods, re-entry catheters or CTO crossing devices (Figure 2), but that an appropriate strategy should be to become familiar with one or two devices in each category and incorporate them into a mix. Complex CTOs Scrub in with the Experts CTOs were also the core focus in the Scrub in with the Experts VIVA session at LINC, with presentations and live cases that offered further exploration of cutting-edge concepts in the field. As both chairman and a presenter of the session, Michael Dake (Stanford, USA) spoke of the impact of the session. I think there is a lot of interest in this topic because CTOs are probably one of the most complex lesions that we deal with in peripheral artery endovascular management, he said. I really cannot think of anything that is quite as potentially complex to deal with. They come in all varieties: multilevel disease, short segment diseases, long segment disease, and I think for the attendee at the course or the session, what they really want to ask is: I have a way of doing it and, when that doesn t work, what are 64 I think there is a lot of interest in this topic because CTOs are probably one of the most complex lesions that we deal with. Michael Dake (Stanford, USA)

65 the options?. To address these sorts of issues, a number of didactic presentations featured in the session, including one from Dr Dake in which he examined various anatomic sites where CTOs exist, i.e. the popliteal, the superficial femoral artery (SFA) and the tibial arteries, and highlighted similarities and differences in the strategies one uses to recanalise these total occlusions based on their anatomic locations. Beginning by describing how to deal with CTOs, he said: The critical first step is crossing the lesion and safely arriving back in the true lumen, adding that hydrophilic wires and catheters, re-entry technologies and devices that maintain lumen position are a useful facet in this process. The time-tested solution that successfully crosses CTO s in the vast majority of cases is the subintimal technique, added Dr Dake. With this in mind, he continued to discuss subintimal entrapment (which occurs in 20 30% of CTO cases), stressing that subintimal approaches run the risk of extending the length of the lesion, thus requiring longer stents (which in turn affects restenosis rates), and also having an impact on collaterals and strut fracture in the popliteal artery. Why does the wire go subintimal? said Dr Dake. Ultimately the wire takes the path of least resistance and deflects off of hard plaque and fibrous caps to the outer margin of the lumen. The wire then creates a cleavage plane within the muscular layers of the artery or between the vessel wall and the plaque. Why does the wire stay subintimal? If the distal target is not calcified, fibrotic, or diseased, the wire will routinely pop through the thin-walled intima and back into the true lumen. If that is not the case, then the path of least resistance is for the wire to remain subintimal and to continue to extend the occlusion distally. Summarising the field of CTOs for SFA/femoropopliteal occlusions specifically, Dr Dake stressed that these types of CTO represent one of the more challenging subsets of lesions faced in endovascular procedures. That being said, numerous techniques now exist to aid in successful lesion crossing, as long as clinical judgement is applied during case selection, alongside device training and further research. For the tibial arteries, previously unapproachable CTOs are now able to be addressed with novel wires, alternative access routes, newer true lumen crossing devices, and CTO reentry devices. Acute procedural success includes PTA, cryoplasty, possibly atherectomy, and consideration for DEB and stents (DES), said Dr Dake. Long-term results for PTA alone are dismal, but may lead to wound healing. Very few cases are truly undoable. He continued, giving a glimpse to what the future may hold for CTOs: At the present time our technical ability to traverse occlusions successfully greatly outstrips our clinical ability to keep said vessels patent. Drug/ device combinations have shown early promise, but predominantly in medium length lesions. Current endovascular solutions for long length CTO s remain inferior to bypass. Live cases In addition to presentations, a number of live cases were featured from USA sites in Dallas, Texas and Mountain View, California, during the main LINC afternoon sessions. Dr Dake stressed that as with the presentations, these cases served to highlight the notion of thinking on your feet, and finding a way to manoeuvre around challenges in real time. Obviously with other types of lesions, the potential for this is probably not as great, but with CTOs, even though the ultimate success rate is high now with all the skills we have, it s the case where you have to take advantage of all those skills and adjunctive devices to achieve that, he said. Continued on page 66 65

66 Collaborations at LINC: VIVA Continued from page 65 The Dallas live cases were performed by operator Tony Das (Dallas, USA). The first case was a gentleman in his 80s with an occluded distal tibial vessel, with non-healing ulcers, and a posterior tibial artery that was 100% occluded. He has no stump to show me where exactly it starts, explained Dr Das. The plan would be to come retrograde from the foot back up through the tibial artery and recanalise, using atherectomy and a chocolate balloon. The teaching point here is the retrograde access, specifically using ultrasoundguided retrograde access. I know that Dierk Scheinert and Andrej Schmidt often use angiographic retrograde tibial access, but we will be using no contrast, just purely by ultrasound only, which would then allow us to cross the occlusion without fluoroscopy or any need for contrast until we re completed. So it s kind of a unique approach. Offering an overall summary of why he chose the cases to focus on during the LINC session, Dr Das underlined that the core reason was the inherent complexity and unique nature of the techniques used. Indeed, OCELOT and cryoplasty are rarely used in Europe, he explained, whilst trials in the US have shown significant benefit. Of course, with a collaboration such as LINC, one can examine the similarities and differences that occur when renowned meetings from two different continents come together. Dr Das added his thoughts on the collaboration between VIVA and LINC in these sessions, saying: Obviously, one of the things that we enjoy is the relationship of learning from each other. What we get from them is they have had some of these devices for much longer than we have so we have had the chance to see the path of what the devices are going to do over the course of months to years with large experience, so then we see whether there are pitfalls in devices. Maybe they get approved sooner, but also they lose favour sooner as well, so we do get some advantage there. Also, Dierk and his colleagues have been very forward-thinking about techniques and approaching difficult cases, and we will share some of that enthusiasm. Our role it to try and reiterate some way in which medical education can advance. We have some things such as strategies from the frontline that Dierk thought was very interesting thus he incorporated it into LINC last year, having seen it at VIVA the year before. So I think here is a fair amount of exchange, and the way in which we educate as well. Dr Jaff added his thoughts on the collaboration: LINC is the most extraordinary vascular intervention meeting there is as far as I am concerned, anywhere in the world. Dierk and Andrej and their team are incredible operators, with a rich variety of pathology for people to watch, and they bring the best and brightest in the world to talk about experiences and techniques and new technologies. I really learn a lot from attending the meeting, and those of us with VIVA really feel it is a real learning experience. He continued: What do we bring? We bring the US perspective. We re behind Europe when it comes to new technology release, but I think we re very good with data and clinical trials and strategies. Moreover, we re facing slightly difference economic challenges than the EU is facing, so we bring those types of discussions to the table. I don t think you can talk about medicine anymore without talking about cost-effectiveness and the value for patients in what you are doing. I think it s a very, very collaborative experience, and I hope we bring some novel approaches to education in the meeting as well. 66 Obviously one of the things that we enjoy is the relationship of learning from each other. Tony Das (Dallas, USA

67 Why I do what I do for SFA occlusions Invited experts gathered to share their individual strategies in the treatment of superficial femoral artery (SFA) occlusive disease on Wednesday at LINC, with management options, device choices and the latest trial data all put forward for discussion. Chairing the session was Peter Soukas (Rhode Island, USA), who began proceedings by offering a run-down of his experience and choices in treating patients in this field. The first question of course is in treating a de novo lesion: How to you decide which of the various tools to use? he said. There are several variables that I take into account and synthesise in my decision making process about treating SFA disease. I think for most of us, length of lesion is probably the foremost individual variation that we take into consideration when embarking on a strategy of treating the SFA, but we also know that calcification is our biggest nemesis, and has to be addressed as well. We know from vascular surgery studies, as well as a lot of the peripheral studies that have been published to date, that vessel runoff is a very important determinant of long-term outcomes, but also other variables such as vessel diameter, location of the lesion (be it ostial, mid or distal) and particularly if it involves the popliteal area. All of those are important. He added that there were also confounding variables in terms of patients willingness to continue certain post-procedural therapies (dual antiplatelets, for example), as well as regional considerations. Specifically, within his centre, Dr Table 1. Lesion length, patency and follow-up duration in the latest bare metal stent trials Soukas stressed that he did not have immediate access to drugeluting stents or drug-coated balloons, thus other treatment methods such as atherectomy, self-expanding stents and suchlike naturally become more prevalent. In his presentation during the session, Gerrit Krupski-Berdien (Reinbek, Germany) gave an overview of recent trials in the SFA, leading to which treatment approaches these studies would suggest as the most promising. Starting with bare metal stents, he listed several trials as shown in Table 1. SUPERA is probably one of the best bare metal stents, with a long patency rate of 76.1% at 24 months, which is pretty good, said Dr Krupski-Berdien. RESILIENT has just been updated this year from the Dierk Scheinert group here in Leipzig, and it does very well as well, but in fact they were very short lesions that they took a focus on. The EverFlex stent is good it is all ranging around 70% [patency] in the first year... and in Continued on page 68 Do not miss LINC@CICE during the CICE 2013 Symposium Wednesday 24 April, 2013 Advanced revascularization concepts for complex peripheral obstructions Chairmen: G. Biamino and M. Bosiers Pioneering techniques in endovascular interventions Chairman: R. Ferraresi

68 Why I do what I do for SFA occlusions Continued from page 67 the VIASTAR control group we had 2cm medium length CTOs, and the control group was not metal but bare nitinol stents, who had a 48% patency at 12 months. He added: So with short lesions we reach about 70-75% patency in up to three years. Moving on to discuss drug-eluting balloons, Dr Krupski-Berdien stressed that, while many studies have shown a clear benefit to patency when using drug-eluting versus plain balloons, the mechanical effect on the vessel remains unchanged, which in turn means complications such as dissection are of concern. He added that drug-eluting stents are promising, and there are now a number of trials that have exhibited patency of around 80% for shorter lesion lengths after one-year follow-up. A core device family that Dr Krupski-Berdien was keen to discuss was that of endoluminal grafts featuring a proprietary rapidly stretching polytetrafluoroethylene polymer known as eptfe (W. L. Gore & Associates, Newark, Delaware, USA), of which the Viabahn and (former) Hemobahn are the main representatives. Referring to wealth of studies surrounding these devices (Table Table 2. Lesion length, patency and follow-up duration in the latest endoluminal graft trials 2), he said: All these studies focus on very, very long lesions, and that is the crucial difference between all the other things we could think about. One stand-out study that Dr Krupski-Berdien highlighted was that of Fritschy et al., who observed a 79.8% primary patency after three years when using endoluminal grafting, i.e. comparable to surgery. However, he added that the 12 month results from the Hemobahn/Viabahn review (Doomernik et al.) were more likely to reflect a more real situation, as they included mixed positive and negative results. Table 2 shows accumulated data from a large number of trials utilising the Viabahn and Hemobahn endoprostheses. Looking at the average patency rates of these studies for up to four years post-procedure, Dr Krupski- Berdien underlined that these data would suggest that approximately 76/77% (one year) down to 59% (four years) patency would be maintained as years progressed, which is comparable to vascular Continued on page 70 Figure 1. Demonstrating the felxibiliy of the GORE TIGRIS stent 68 Theoretically we have the best stent we could imagine for femoropopliteal lesions. Ulf Teichgräber (Jena, Germany)

69 Header Do not miss During the CICE 2013 Symposium Wednesday 24 April, :00 Advanced revascularization concepts for complex peripheral obstructions Chairmen: G. Biamino, M. Bosiers Moderators: D. Scheinert, A. Amin Live Case Coordinator: L. F. Mendes Rodrigues Secretary: S. L. Pinto Surmonte Live case transmission Crossing the challenging CTO: Tips and tricks from the expert A. Schmidt Treatment of long SFA-lesions: What is best practice in arterial recanalization? M. Bosiers Live case transmission Stenting the SFA: Current results and considerations for device selection D. Scheinert Live case transmission The promise of peripheral DEB: Durable results without metallic implants? G. Biamino Live case transmission Pioneering techniques in endovascular interventions Chairman: R. Ferraresi Moderators: K. Deloose, Guo Wei, G. Biamino Live Case Coordinator: C. Eloy da Costa Secretary: G. Angheben Berthier Live case transmission The angiosome concept in real practice: How to guide our revascularization strategies? R. Ferraresi Live case transmission Extreme interventions in BTK advanced access and wiring techniques M. Manzi live from Leipzig Optimal solutions for the popliteal artery Live case transmission Making the right choice in BTK: DEB vs. DES vs. atherectomy vs. POBA K. Deloose Live case transmission All live cases will be broadcasted from the Centre of Vascular Medicine at the Park Hospital Leipzig, Germany. Operators will be: Prof. Dierk Scheinert, Dr. Andrej Schmidt, Dr. Sven Bräunlich, Dr. Matthias Ulrich, Dr. Johannes Schuster 69

70 Why I do what I do for SFA occlusions Continued from page 68 surgery results. Offering a summary of his main messages, Dr Krupski-Berdien commented: eptfe endografts and drug-eluting stents perform best (amongst all the other things) in long CTO s and long lesions. You can use both of them for long lesions. If you have between 10cm and 15cm lesions, I think this is something actually to be discussed what are the breakpoints for these different materials? Fortunately, the eptfe endografts show high patency rates for long periods of time, and compared to the other many studies and trials we have, these studies take a longer period of time something I think we lack in the entire endovascular treatment [arena] is that we have fewer long term data on patency overall. Also speaking during the session was Ulf Teichgräber (Jena, Germany), who gave an overview of his experience with bare metal stents, with particular focus on the Gore TIGRIS stent. Dr Teichgräber began by commenting on the current status of the field: I think there are still some unmet needs, especially for short focal lesions. Especially for those lesions we want to have Figure 2. Application of the TIGRIS Stent 70 I think for most of us, length of lesion is probably the foremost individual variation that we take into consideration when embarking on a strategy of treating the SFA. Peter Soukas (Rhode Island, USA)

71 a stent which allows for radial compression, but is resistive on the other hand for longitudinal compression and extension. And then we also want to have a stent which has complete flexibility and also allows for a certain degree of torsion. To address these design goals, Gore developed the dual component TIGRIS stent design, which Dr Teichgräber described: It is actually specially designed to meet the demands of maximised flexibility while minimising risk of stent fracture, and allowing axial compression while resisting stent elongation. These are completely contradictory points usually! It also somehow has to be a stent which mimics the normal regular artery, conforming and behaving like a normal vessel. The unique design of the stent incorporates a clinically-established stent frame complete with nitinol wires which are interconnected with a PTFA polymer. Furthermore, a bioactive CARMEDA surface is built-in, being adapted from the established Viabahn device. The PTFA interconnected nitinol structure imparts a significant improvement in flexibility when compared to standard nitinol stents, avoiding common problems such as compression of the lumen, bent struts or elongation effects. However, Dr Teichgräber stressed that for true comparison, the TI- GRIS needed to be compared with other cutting-edge stents trying to address the issue of flexibility. To that end, Figure 1 shows direct flexibility comparison between TIGRIS and the cutting-edge interwoven SUPERA stent (IDEV). Dr Teichgräber commented: At first glance it looks the same in terms of flexibility, but what we don t [immediately] see in the image is that the SUPERA stent has a certain degree of elongation when you bend the stent, and also the lumen is changing. He added that large-scale comparisons between currentlyavailable stent designs reveal that the TIGRIS is in fact the most ideal stent in terms of minimised elongation and low straightening force. Theoretically we have the best stent we could imagine for femoropopliteal lesions, said Dr Teichgräber. In terms of their clinical experience, Dr Teichgräber and his team have now implanted the TIGRIS stent in twelve patients (19 lesions), focussing mainly on TASC A and B lesions in the distal femoral artery and popliteal artery. He showed a number of examples from these cases, ranging from shorter to longer lesions, all to great success. One of the examples is a segment P2/3 occlusion, shown in Figure 2. Here we have a quite a long lesion, nearly 7.5cm, in the popliteal artery, he said. After implantation you can see how nicely it matches the [anatomy], and also a very nice run-off. Offering his conclusions, Dr Teichgräber commented: With the new TIGRIS stent we have a dual component stent which is a unique and totally new design. It has unique combinations of minimal stent elongation which actually no bare metal stent has on the market so far and it has a low straightening force and the ability to absorb longitudinal and axial compressions. It mimics the vessel movement (mimics the normal artery) and also has the potential for less stent fracture, and has no disturbing artefacts in MR-angiography. So what we have to now wait for is how does our registry data and also randomised data [compare] with other stent systems. I think it is an ideal stent for short and medium sized femoropopliteal lesions.

72 Challenging Case LINC The winner of this year s award for the Challenging Case presentation at LINC 2013 was chosen by the multidisciplinary and international jury as Endovascular treatment of postthrombotic syndrome in chronic iliac venous occlusion secondary to bull horn injury, by Dr Deborah Cervell Rodríguez and colleagues from Hospital Universitario Madrig Montepríncipe Faculty de Medicina Universidad CEU San Pablo, in Spain. The case was that of an 81-yearold man who was referred due to severe post-thrombotic sequelae, defined as Clinical-Etiology- Anatomy-Pathophysiology (CEAP) class 6. The patient was a former professional bullfighter who suffered a bull-horn injury in 1963 that affected his femoral and iliac vessels. Newspaper reports at the time described an emergency surgical procedure in the bullring with simple direct in-block vessel suture in order to save the patient s life. For the current work-up, the 72 team performed echo-doppler and computed tomography angiography, which revealed occlusion of the right external iliac vein suggestive of a chronic scar and collateral circulation to the common iliac vein and suprapubical right-to-left circulation. The team decided to perform endovascular therapy. They achieved echo-guided femoral vein access, and recanalised the occlusion with a Terumo (Tokyo, Japan) stiff guidewire over a 5 French Bernstein catheter. The team successfully performed angioplasty and stenting with Zilver-Vena 14x140 and 14x60 stents (Cook Medical, Bloomington, Indiana, USA). After three months, an elevated D-dimer was observed, and stent re-stenosis was recorded on echo-doppler. The team therefore performed stenting with a 14x140 Zilver-Vena, with excellent angiographic results. At 24-month follow-up, the stents remained patent, and the patient has improved to CEAP class 5. The team concludes: Iliofemoral venous stenting is a wellknown treatment of chronic total occlusion. This case is singular because of its etiology and the time elapsed between the injury and treatment.

73 Digital LINC A novel way of engaging with the latest, cuttingedge research from around the globe was developed for LINC On Wednesday, Thursday and Friday, moderated posters were presented in digital format in a new Forum by the LINC Studio. This offered young doctors the opportunity to present their scientific work to a truly international and interdisciplinary audience, and give attendees the opportunity to understand and examine their work in an innovative and educative format. Each day s programme of posters featured a wide range of topics, including venous, other/renal, peripheral vascular disease (PVD) femoropopliteal, PVD aorto-iliac, endovascular aortic, and supra aortic/carotid. Furthermore, the winning poster, by Rutger Stokmans, from Catharina Hospital in Eindhoven, The Netherlands, was presented on Saturday morning. Entitled Challenging the evidence for pre-emptive coil embolisation of the internal iliac artery during endovascular aneurysm repair, the poster (see Figure) explained that Stokmans et al registered all patients who were scheduled for endovascular aneurysm repair (EVAR) with extension of a limb graft into the external iliac artery (EIA) between January 2010 and May 2010 were registered in a database and included in the study. The team also retrospectively reviewed the procedural records of all EVAR procedures to identify and include cases in which inadvertent stent-graft coverage of the internal iliac artery (IIA) had occurred. All patients underwent preoperative computed tomography angiography (CTA) to assess the need for IIA coverage, the dimensions of the common iliac artery tract, and the presence of flow I the proximal and distal IIA branches. Patients were followed up at one, six, and twelve months, and subsequently once yearly as part of a standard follow-up regimen. CTA was used at year one follow-up, with duplex ultrasonography used after that. Patients were also asked about buttock claudication during follow-up, and endoleaks and the evolution of aneurysm diameters were registered. Overall, 191 EVAR procedures were performed during the timeframe. A total of 32 consecutive patients underwent unilateral stent coverage. Of these, one patient died a few days postoperatively, while the remaining 31 had an average follow-up of 14.3 months. All patients completed one-month follow-up, while 24 completed one-year follow-up or died. Technically, coverage of the IIA orifice with 10% oversizing relative to the EIA was achieved in all patients. There were no endoleaks, and no distal type II endoleaks from the covered IIA were recorded. Furthermore, no aneurysm growth was observed. Clinically, five patients experience mild buttock claudication, while two patients had severe claudication. There were no cases of ischemic colitis or gluteal necrosis. The team concludes: Endovascular treatment of aorto-iliac and iliac aneurysm without pre-emptive coil embolisation of the IIA appears to be safe and effective. No IIA-related endoleaks or reinterventions occurred in our series. They add: This approach saves operating-time, contrast load and costs, and may reduce complications. However, a larger series and longer follow-up is required to confirm our findings. 73

74 LINC 2013 We would like to sincerely thank the outstanding faculty for their collaboration and commitment, and our generous industry partners for their support in making it an exciting and successful meeting. Scientific Committee Iris Baumgartner, Angiologist, Bern, Switzerland Giancarlo Biamino, Cardiologist/Angiologist, Italy Piergiorgio Cao, Vascular Surgeon, Rome, Italy Roger Greenhalgh, Vascular Surgeon, London, UK Michael Jaff, Angiologist, Boston, USA Friedrich Wilhelm Mohr, Cardiac Surgeon, Leipzig, Germany Dierk Scheinert, Cardiologist, Angiologist, Leipzig, Germany Andrej Schmidt, Cardiologist, Angiologist, Leipzig, Germany Gerhard Schuler, Cardiologist, Leipzig, Germany Karl-Ludwig Schulte, Angiologist, Berlin, Germany Giovanni Torsello, Vascular Surgeon, Münster, Germany Thomas Zeller, Cardiologist/Angiologist, Bad Krozingen, Germany Live Case Committee Gary Ansel, Cardiologist, Columbus, USA Martin Austermann, Vascular Surgeon, Münster, Germany Alberto Cremonesi, Cardiologist, Cotignola, Italy Ralf Langhoff, Angiologist, Berlin, Germany Felix Mahler, Angiologist, Bern, Switzerland Antonio Micari, Cardiologist, Palermo, Italy Andrej Schmidt, Cardiologist, Angiologist, Leipzig, Germany Giovanni Sorropago, Cardiologist, Mercogliano, Italy Eugenio Stabile, Cardiologist, Mercogliano, Italy Frank Vermassen, Vascular Surgeon, Gent, Belgium Thomas Zeller, Cardiologist, Angiologist, Bad Krozingen, Germany Invited Faculty Sebastian Debus, Vascular Surgeon, Hamburg, Germany Flavio Airoldi, Cardiologist, Milano, Italy Koen Deloose, Vascular Surgeon, Dendermonde, Belgium Bagrat Alekyan, Cardiologist, Moscow, Russia Steffen Desch, Cardiologist, Leipzig, Germany Max Amor, Cardiologist, Essey-lès-Nancy, France Nuno Dias, Vascular Surgeon, Malmö, Sweden Martin Andrassy, Interventional Cardiologist, Heidelberg, Germany Dai-Do Do, Angiologist, Bern, Switzerland Jörn Balzer, Interventional Radiologist, Mainz, Germany Konstantinos Donas, Vascular Surgeon, Münster, Germany Ruy Otavio Barbosa, Vascular/Endovascular Surgeon, São Paulo, Brazil Eric Ducasse, Vascular Surgeon, Bordeaux, France Stanislav Bartus, Cardiologist, Krakow, Poland Stephan Duda, Interventional Radiologist, Berlin, Germany Steffen Basche, Interventional Radiologist, Erfurt, Germany Dariusz Dudek, Cardiologist, Krakow, Poland Yvonne Bausback, Angiologist, Leipzig, Germany Michael Edmonds, Diabetologist, London, UK Jean-Pierre Becquemin, Vascular Surgeon, Paris, France Rolf Engelberger, Angiologist, Bern, Switzerland Ulrich Beschorner, Angiologist, Bad Krozingen, Germany Andrej Erglis, Cardiologist, Riga, Latvia Erwin Blessing, Cardiologist, Heidelberg, Germany Fabrizio Fanelli, Interventional Radiologist, Rome, Italy Dittmar Böckler, Vascular Surgeon, Heidelberg, Germany Roberto Ferraresi, Interventional Cardiologist, Milano, Italy Amman Bolia, Interventional Radiologist, Leicester, UK Robert Fisher, Vascular and Endovascular Surgeon, Liverpool, UK Marc Bosiers, Vascular Surgeon, Dendermonde, Belgium Josef Friedenberger, Angiologist, Leipzig, Germany Spiridon Botsios, Vascular Surgeon, Leipzig, Germany Massimiliano Fusaro, Interventional Cardiologist, München, Germany Karin Brachmann, Vascular Surgeon, Borna, Germany Johannes Gahlen, Vascular Surgeon, Ludwigsburg, Germany Daniela Branzan, Vascular Surgeon, Leipzig, Germany Peter Gaines, Interventional Radiologist, Sheffield, UK Sven Bräunlich, Angiologist, Leipzig, Germany Lawrence Garcia, Cardiologist, Boston, USA Marianne Brodmann, Angiologist, Graz, Austria Reza Ghotbi, Vascular Surgeon, München, Germany Jan Brunkwall, Vascular Surgeon, Köln, Germany Hans Martin Gißler, Interventional Radiologist, Bad Säckingen, Germany Christophe Bureau, Hepatologist, Toulouse, France Yann Gouëffic, Vascular Surgeon, St. Herblain, France Jacques Busquet, Vascular Surgeon, Paris, France Peter Goverde, Vascular Surgeon, Antwerp, Belgium Carlo Caravaggi, Vascular Surgeon, Milan, Italy William Gray, Cardiologist, New York, USA Arindam Chaudhuri, Vascular Surgeon, Bedford, UK Justus Groß, Vascular Surgeon, Kiel, Germany Angelo Cioppa, Cardiologist, Mercogliano, Italy Andreas Gussmann, Vascular Surgeon, Bad Saarow, Germany Trevor Cleveland, Vascular Radiologist, Sheffield, UK Mathias Gutberlet, Interventional Radiologist, Leipzig, Germany Anthony J. Comerota, Vascular Surgeon, Toledo, USA Alison W. Halliday, Vascular Surgeon, Oxford, UK Gioacchino Coppi, Vascular Surgeon, Milano, Italy Nader Hamada, Vascular Surgeon, Galway, Ireland Michael Dake, Cardiologist, Stanford, USA Mohamad Hamady, Interventional Radiologist, London, UK Tony Das, Interventional Cardiologist, Dallas, USA Bernd-Michael Harnoss, Vascular Surgeon, Leipzig, Germany Justin Davies, Consultant Interventional Radiologist, London, UK Nick Hopkins, Neurosurgeon, Buffalo, USA Rick de Graaf, Interventional Radiologist, Maastricht, The Netherlands Peter Huppert, Interventional Radiologist, Darmstadt, Germany Jean-Paul de Vries, Vascular Surgeon, Nieuwegein, The Netherlands Osamu Iida, Cardiologist, Amagasaki, Japan 74

75 Hüseyin Ince, Cardiologist, Rostock, Germany Sri Iyer, Interventional Cardiologist, New York, USA Jim Joye, Cardiologist, Mountain View, USA Michael Jünger, Dermatologist, Greifswald, Germany Piotr Kasprzak, Vascular Surgeon, Regensburg, Germany Marcus Katoh, Interventional Radiologist, Krefeld, Germany Barry Katzen, Interventional Radiologist, Miami, USA Koen Keirse, Vascular Surgeon, Tienen, Belgium Sverre Kjeldsen, Cardiologist, Oslo, Norway Matthias Knittel, Angiologist, Bad Krozingen, Germany Tilo Kölbel, Vascular Surgeon, Hamburg, Germany Ralf Kolvenbach, Vascular Surgeon, Düsseldorf, Germany Stavros Konstantinides, Cardiologist, Mainz, Germany Nils-Einar Kløw, Interventional Radiologist, Oslo, Norway Antonin Krajina, Interventional Radiologist, Hradec Kralove, Czech Rep. Hans Krankenberg, Cardiologist, Hamburg, Germany Juraj Madaric, Cardiologist, Bratislava, Slovakia Lieven Maene, Vascular Surgeon, Aalst, Belgium Michel Makaroun, Vascular Surgeon, Pittsburgh, USA Geert Maleux, Interventional Radiologist, Leuven, Belgium Hannu Manninen, Interventional Radiologist, Kuopio, Finland Marco Manzi, Interventional Radiologist, Abano Terme, Italy Enrico Marone, Vascular Surgeon, Milano, Italy Klaus Mathias, Interventional Radiologist, Dortmund, Germany Robert Melder, Preclinical Development, Santa Rosa, USA Oscar Mendiz, Cardiologist, Buenos Aires, Argentina Christopher Metzger, Interventional Cardiologist, Kingsport, USA Ross Milner, Vascular Surgeon, Chicago, USA Zoran Milosevic, Neuroradiologist, Ljubljana, Slovenia Erich Minar, Angiologist, Vienna, Austria Peter Minko, Interventional Radiologist, Homburg/Saar, Germany Martin Misfeld, Cardiac Surgeon, Leipzig, Germany Patrick Peeters, Vascular Surgeon, Bonheiden, Belgium Jean Marc Pernes, Interventional Radiologist, Antony, France Michael Piorkowski, Angiologist, Leipzig, Germany Graham Plant, Consultant Interventional Radiologist, Basingstoke, UK Andrew Platts, Interventional Radiologist, London, UK Salah-Dine Qanadli, Interventional Radiologist, Lausanne, Switzerland Claudio Rabbia, Interventional Radiologist, Turin, Italy Kalkunte Rangaswamy Suresh, Vascular Surgeon, Vasanthnagar, Bangalore Dieter Raithel, Vascular Surgeon, Nürnberg, Germany Venkatesh Ramaiah, Vascular Surgeon, Phoenix, USA Stephen Ramee, Cardiologist, New Orleans, USA Thomas Rand, Interventional Radiologist, Wien, Austria Richard Rapoza, Engineer, Santa Clara, USA Michel Reijnen, Vascular Surgeon, Arnhem, The Netherlands Vincent Riambau, Vascular Surgeon, Barcelona, Spain Wolfgang Ritter, Interventional Radiologist, Nürnberg, Germany Gerrit Krupski-Berdien, Interventional Radiologist, Reinbek, Germany Frans Moll, Vascular Surgeon, Utrecht, The Netherlands Miloslav Roček, Interventional Radiologist, Praha, Czech Republic Dusan Kucera, Cardiologist, Czech Republic Nils Kucher, Cardiologist, Bern, Switzerland Karl-Heinz Kuck, Cardiologist, Hamburg, Germany Vinay Kumar, Vascular Surgeon, Laurel, USA Mario Lachat, Vascular Surgeon, Zürich, Switzerland Johannes Lammer, Interventional Radiologist, Wien, Austria Thomas Larzon, Vascular Surgeon, Örebro, Sweden Michael Lichtenberg, Cardiologist, Essen, Germany Francesco Liistro, Cardiologist, Arezzo, Italy Hans Lindgren, Interventional Radiologist, Helsingborg, Sweden Piero Montorsi, Cardiologist, Milano, Italy Pramook Mutirangura, Vascular Surgeon, Bangkok, Thailand Stefan Müller-Hülsbeck, Interventional Radiologist, Kiel, Germany Darren Mylotte, Interventional Cardiologist, Montreal, Canada Paul Myers, Vascular Surgeon, New Lambton Heights, Australia Krzysztof Narkiewicz, Cardiologist, Gdansk, Poland Christoph Nienaber, Cardiologist, Rostock, Germany Sigrid Nikol, Cardiologist/Angiologist, Hamburg, Germany Thomas Nolte, Vascular Surgeon, Bad Bevensen, Germany Thomas Noppeney, Vascular Surgeon, Nürnberg, Germany Krishna Rocha-Singh, Cardiologist, Springfield, USA Marco Roffi, Cardiologist, Geneva, Switzerland Kenneth Rosenfield, Cardiologist, Boston, USA Georg Rothenbacher, Vascular Surgeon, Karlsruhe, Germany Hervé Rousseau, Interventional Radiologist, Toulouse, France Paolo Rubino, Cardiologist, Mercogliano, Italy Johannes Ruef, Cardiologist, Frankfurt, Germany Ralph-Ingo Rückert, Vascular Surgeon, Berlin, Germany Marc Sapoval, Interventional Radiologist, Paris France Ahmed Sayed, Vascular Surgeon, Cairo, Egypt Axel Linke, Cardiologist, Leipzig, Germany Jorge Fernandez Noya, Vascular Surgeon, Santiago de Compostela, Spain Philipp Schäfer, Interventional Radiologist, Germany Armando Lobato, Vascular Surgeon, São Paolo, Brazil Robert Lookstein, Interventional Radiologist, New York, USA Mads Lomholt, Consultant Vascular Surgeon, Viborg, Denmark Piotr Odrowaz-Pieniazek, Cardiologist, Krakow, Poland Gerard O Sullivan, Interventional Radiologist, Galloway, Ireland John Paul Pacanowski, Vascular Surgeon, Tucson, USA Ingo Schiefke, Gastroenterologist, Leipzig, Germany Peter Schneider, Vascular Surgeon, Honolulu, Hawaii Joachim Schofer, Cardiologist, Hamburg, Germany Alan Lumsden, Vascular Surgeon, Houston, USA Juan Carlos García Pagán, Consultant Hepatologist, Barcelona, Spain Gerhard Schroth, Neuroradiologist, Bern, Switzerland Martina Luxenburger-Theobald, Nurse, Schellweiler, Germany Sean Lyden, Vascular Surgeon, Cleveland, USA Sumaira Macdonald, Interventional Radiologist, Newcastle, UK Paresh R. Pai, Vascular Surgeon, Mumbai, India Andrea Pascotto, Interventional Cardiologist, Mestre, Italy Pankaj Patel, Vascular Surgeon, Mumbai, India Johannes Schuster, Angiologist, Leipzig, Germany Thomas Schwarz, Angiologist, Bad Krozingen, Germany Continued on page 76 75

76 LINC 2013 Arne Schwindt, Vascular Surgeon, Münster, Germany Sven Seifert, Vascular Surgeon, Chemnitz, Germany Carlo Setacci, Vascular Surgeon, Siena, Italy Horst Sievert, Cardiologist, Frankfurt/Germany, Washington/USA Varinder Singh Bedi, Vascular Surgeon, New Delhi, India Sebastian Sixt, Angiologist, Hamburg, Germany Paul Sobotka, Cardiologist, Minneapolis, USA Peter Soukas, Vascular Surgeon, Rhode Island, USA Markus Steinbauer, Vascular Surgeon, Regensburg, Germany Hermann Steinkamp, Radiologist, Berlin, Germany Martin Storck, Vascular Surgeon, Karlsruhe, Germany Peter Taylor, Vascular Surgeon, London, UK Ulf Teichgräber, Interventional Radiologist, Jena, Germany Jörg Teßarek, Vascular Surgeon, Lingen, Germany Carlos Timaran, Vascular Surgeon, Dallas, USA Matt Thompson, Vascular Surgeon, London, UK Santi Trimarchi, Vascular Surgeon, San Donato Milanese, Italy Thilo Tübler, Cardiologist, Hamburg, Germany Christian Ukena, Cardiologist/Elektrophysiologist, Homburg/Saar, Germany Matthias Ulrich, Angiologist, Leipzig, Germany Kazushi Urasawa, Cardiologist, Sapporo, Japan Jos van den Berg, Interventional Radiologist, Lugano, Switzerland Marc van Sambeek, Vascular Surgeon, Eindhoven, The Netherlands Ramon Varcoe, Vascular Surgeon, Sydney, Australia Frank Veith, Vascular Surgeon, New York, USA Hence Verhagen, Vascular Surgeon, Rotterdam, The Netherlands Eric Verhoeven, Vascular Surgeon, Nürnberg, Germany Pierfrancesco Veroux, Vascular Surgeon, Catania, Italy Fabio Verzini, Vascular Surgeon, Perugia, Italy Vincent Vidal, Interventional Radiologist, Marseille, France Renu Virmani, Pathologist, Gaithersburg, USA Britta Vogel,Cardiologist, Heidelberg, Germany Oliver Vonend, Nephrologist, Düsseldorf, Germany Eva von Hodenberg, Angiologist, Bad Krozingen, Germany Craig Walker, Cardiologist, Lafayette, USA Eberhard Wedell, Cardiologist, Bad Neustadt, Germany Martin Werner, Angiologist, Leipzig, Germany Michael Werk, Interventional Radiologist, Berlin, Germany Torsten Willenberg, Antiologist, Bern, Switzerland Hiroyoshi Yokoi, Cardiologist, Kitakyusyu, Japan Associated Faculty George Adams, Interventional Cardiologist, Wake Forest, USA Nelson Bernardo, Interventional Cardiologist, Washington, USA Robert M. Bersin, Interventional Cardiologist, Seattle, USA Bob Brightwell, Vascular Surgeon, Columbus, USA Ian Cawich, Vascular Surgeon, Little Rock, USA Neal Cayne, Cardiac Surgeon, New York, USA Brian de Rubertis, Vascular Surgeon, Los Angeles, USA Suhail Dohad, Interventional Cardiologist, Beverly Hills, USA Parag Doshi, Interventional Cardiologist, Elk Grove Village, USA Jon George, Interventional Cardiologist, Philadelphia, USA Mark Goodwin, Interventional Cardiologist, Naperville, USA Lonnie Harrison, Cardiologist, Benton, USA Robert Hieb, Interventional Radiologist, Milwaukee, USA Jackie P. Ho, Vascular Surgeon, Singapore, Singapore Syed Hussain, Vascular Surgeon, Peoria, USA Patrick Kelly, Vascular Surgeon, Sioux Falls, USA Young Guk Ko, Cardiologist, Seoul, Korea Junhao Jiang, Vascular Surgeon, Shanghai, China Ethan Korngold, Cardiologist, Portland, USA Richard Kovach, Interventional Cardiologist, Browns Mills, USA Arthur Lee, Interventional Cardiologist, Gainesville, USA Christopher Lesar, Vascular Surgeon, Chattanooga, USA Evan Coulson Lipsitz, Vascular Surgeon, New York, USA Dan Martin, Vascular Surgeon, Albany, USA Carlos Mena-Hurtado, Interventional Cardiologist, Hamden, USA Charles Moomey, Vascular Surgeon, Lawrenceville, USA Erin Moore, Vascular Surgeon, Jacksonville, USA Nicholas Morrissey, Vascular Surgeon, New York, USA Patrick Muck, Vascular Surgeon, Cincinnati, USA Aravinda Nanjundappa, Interventional Cardiologist, Charleston, USA Bhagat Reddy, Interventional Cardiologist, Atlanta, USA Darren Schneider, Vascular Surgeon, New York, USA Barry Weinstock, Interventional Cardiologist, Orlando, USA Michael Wilderman, Vascular Surgeon, Hackensack, USA Edward Woo, Vascular Surgeon, Philadelphia, USA Zhidong Ye, Vascular Surgeon, Beijing China Jason Yoho, Interventional Cardiologist, New Braunsfeld, USA 76

77 Sponsors and LINC 2013 We would like to sincerely thank the following organisations for their generous support of LINC Aachen Resonance Abbott Vascular Aptus Argon Medical Devices Asahi Intecc Atrium Avinger B. Braun Melsungen Bayer HealthCare Bentley InnoMed Biotronik Boston Scientific Cardionovum Cook Medical Cordis Covidien C. R. Bard CX Symposium EKOS Corporation Endologix International Endoscout Endovascular Today Eurocor Gore & Associates Hansen Medical IDEV Joline JOTEC Kyoto Medical Planning LeMaitre MediTech Medtronic Mentice Minerva Medica Optimed Oscillon Pan Medical Qualimed Siemens SITE Spectranetics International St. Jude Medical Straub Medical Teleflex Medical TeraRecon Terumo Thermopeutix TriReme Medical TriVascular Upstream Peripheral Technologies technologies.com VIVA Wisepress 77

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80 LEIPZIG INTERVENTIONAL COURSE Save the Date! LINC 2014 January