CHARING CROSS SPECIAL EDITION March 2016 2016 Vascular & Endovascular Challenges Update Tackling the challenges in the vascular and endovascular arena

Peripheral Acute Aortic Venous Arterial Stroke Challenges Challenges Challenges Challenges

Halfway through its Controversies, Challenges and Consensus allow the audience to interact with the Challenges Programme—new as of cycle, the Charing Cross Symposium will examine this year the speakers and panel at every stage. 2016—will make its debut. The half-day numerous and varied challenges currently facing the vascular This year, the CX Venous Challenges Programme is being introduced following and endovascular field. The Symposium will be held from 26 to 29 Main Programme will, for the first time, the realisation that a number of strokes April 2016 at Olympia Grand, London, UK. take place on the Symposium’s opening are caused by interventions in the aorta day, exploring the use of various technolo- and manipulations in the arch. his year’s Peripheral Arterial trial to be conducted, gies and techniques for the treatment of The purpose of the Acute Stroke Chal- Challenges session will centre and the first to reach fifteen-year follow- superficial and deep venous disease with lenges Main Programme is to encourage around management of the up. The 10-year data, presented at CX emphasis on the latest evidence of when a multidisciplinary approach, such that superficialT femoral artery. Treatment 2010, demonstrated no significant dif- and in which patients they should be used. unwanted emboli to the brain can be man- strategies, varying depending on lesion ferences between endovascular and open The topics for discussion will include aged by clot retrieval, and the optimisation type and length, will be analysed, with repair in terms of mortality. acute deep thrombosis and deep vein of referral so that stroke patients reach the a special emphasis on the status and Another first-time presentation in the stenting challenges, proximal deep venous best hands as fast as possible. expectations of drug-coated balloons, Abdominal Aortic Main Programme will obstruction and pelvic vein reflux chal- The new CX drug-eluting , new biomimetic and be an Individual Patient Data meta- lenges. A new session on lymphoedema Course will be held on the second, third swirling flow stents and grafts. analysis of the EVAR vs. open repair challenges will precede discussions on and fourth days of the Symposium. The Delegates will be able to learn new randomised controlled trials—EVAR 1, superficial venous challenges. Course will provide both experts and those techniques for femoropopliteal lesion DREAM, OVER and ACE. The ever-popular CX Venous new to the field with invaluable insights treatment through attending the CX On the third day, the Main Programme Workshop will run throughout days into the challenges currently facing haemo- Peripheral Arterial Live Cases, which will be dedicated to challenges in the two and three, consisting of one-to-one dialysis vascular access, and the methods returns after its successful 2015 debut. treatment of thoracic aortic diseases, with demonstrations by world-leading experts. used to overcome them. The three-day This year’s live cases will be broadcast an emphasis on type B dissections. The Workshop will expand on the Course will bring together world experts to from Münster, Germany. Also on the third day, the CX Aortic Ed- technical aspects of the key superficial cover current practice and remaining chal- The main talking point of the 2016 Ab- ited Cases will explore the application of and deep venous topics discussed in the lenges. It will be made up of a masterclass dominal Aortic Challenges session is the different techniques in complex thoracic CX Venous Main Programme. This year, on ischaemic steal syndrome, a practical presentation—for the first time—of15- aortic and abdominal aortic procedures. a new section on aesthetic phlebology skills course and an abstract presentation year follow-up data from the Endovas- The format will be that of short case will also be included in the workshop. day, immersing delegates in the most im- cular Aneurysm Repair (EVAR) 1 Trial, presentations followed by imaging and On the final day of this year’s portant issues and innovation in haemodi- the first EVAR vs. open repair abdominal indications for the procedure, and will Symposium, the Acute Stroke alysis vascular access medicine.

VascularNews.com Facebook.com/VascularNews @VascularNews VN App 2 Charing Cross Symposium March 2016 Management of the superficial femoral artery Delegates to learn techniques for femoropopliteal at the centre of the discussions at CX lesions with the CX live-case method

26 APRIL 2016 topics are related 27 APRIL 2016 edited cases will Day UPPER MAIN to the outcome Day LOWER MAIN also be presented. AUDITORIUM of drug-eluting AUDITORIUM “Our main aim is 1 technologies in 2 to provide highly The management of peripheral inter- Following the successful educational cases. the superficial femoral artery will be at ventions. More first year of the CX Peripheral Arterial During the session, the centre of the discussions at the CX than 20 years after Live Cases, CX 2016 will continue to we will discuss Peripheral Arterial Challenges Day of the establishing drug- Thomas Zeller offer delegates the opportunity to expand indications and Charing Cross Symposium 2016 (Tuesday eluting stents as the discussion of key topics from the CX reasons for us- Giovanni Torsello 26 April). Treatment strategies, depending a first-line strategy in coronary interven- Peripheral Arterial Main Programme by ing a particular on lesion type and length, will be analysed tions, drug-eluting stents and drug-coated demonstrating techniques of how device, we will present specific fea- and there will be special emphasis on balloons are becoming estab- to achieve best results in tures and characteristics of the materi- the status and expectations with different lished for femoropopliteal femoropopliteal le- als and we will demonstrate technical modalities: drug-coated balloons, drug- interventions. Drug- sions through the CX tips and tricks to ensure a safe and eluting stents, new stents (swirling flow coated balloons are live-case method. effective intervention,” said Bisdas. and biomimetic stents) and stent grafts. attractive alternatives This year, live The cases will be divided into two There is high expectation of what can to stent based (bare cases will be different parts. In the first part, differ- be achieved by drug-coated balloons, yet metal and drug- Peripheral transmitted ent techniques supporting the concept there is healthy scepticism on how durable eluting) treatment from Münster, of “leaving nothing behind” will be they will be for longer lesions. “It may take strategies, at least in Arterial Germany, with demonstrated. These include drug-coated two to three years before we know for sure less severe calcified Arne Schwindt balloons in challenging long occlusions, how the drug-coated balloon compares lesions, whereas Challenges and Theodosios and scoring balloons. In with stents particularly for longer lesions,” drug-eluting stents Bisdas as main the second part, the concept of “leaving says Roger Greenhalgh, chairman of the show beneficial clinical operators. Giovanni something in” will be presented. During CX Programme Organising Board. long-term results over Torsello, Thomas these cases, the delegates will have the He continues, “Stents are used more bare metal stents. Interest- Zeller, Iris Baumgartner opportunity to view the deployment of commonly for longer lesions and better ing presentations will include and Michael Jaff will lead drug-eluting stents, biomimetic stents and results are sought by engaging swirl- analyses of specific restenosis patterns audience participation in London stent grafts. Finally, a case of percutane- ing flow or stents with strong radial following drug-eluting stent . and try to shed light on why a technique ous transluminal rotational thrombectomy strength. Data on these technologies will is chosen for a particular situation. Some will be presented. be discussed. Additionally, the value of What do you think are the drug-eluting stents has been demonstrated biggest challenges physi- with five-year data and now newer scaf- cians are facing treating CX ilegx Collaboration Day addresses folds are available. All current options will peripheral arterial disease? be explored at Charing Cross 2016.” In general the biggest challenge in proactive approach to treating the diabetic foot Data on other technologies (atherectomy, some countries is that new and effec- sequential stents and single long stents), tive technologies such as drug-coated 28 APRIL 2016 which are being used in the treatment of balloons and drug-eluting stents are Day PILLAR HALL LEARNING CENTRE long lesions, will also be discussed. not adequately reimbursed, and this Delegates at CX 2016 will also hear new limits their more liberal clinical use 3 With the aim of promoting endovascular procedures, open vascular data on the IN.PACT drug-coated balloon withholding effective treatment op- the best possible care of the surgery, urgent surgical debridement and two-year results in women and diabetics, tions for a large number of patients. ischaemic lower limb to reduce the num- aggressive treatment of infection. The data from IN.PACT Global in total occlu- The most relevant technical challenge ber of major amputations, the CX ilegx clinic is operated by an interdisciplinary sions, outcomes from the German cohort is the treatment of severely calcified Collaboration Day will offer delegates an team comprising surgeon, podiatrist, nurse, in the LEVANT 2 study of the Lutonix lesions. Some potential solutions will overview of the latest treatment strate- orthotist, radiologist and diabetologist. drug-coated balloon, and an interim analysis be discussed during the main ses- gies, particularly in patients with diabetes, Revascularisation strategies will also be of the ILLUMENATE Global study sion of the peripheral programme. one of the main causes of amputations. presented with updates on the BASIL-2 with the Stellarex drug-coated balloon. This year’s ilegx course will start and 3 trials and BEST-CLI trial, and this Concerns regarding in-stent restenosis What are the main chal- with a symposium on diabetic will be followed by the session will be addressed with a specific mini-sym- lenges around the use of vascular disease. Diabetes “To stent or not to stent—that posium on this subject, which will explore drug-coated balloons in the has reached epidemic is the question”. various treatment strategies including drug- SFA and their durability? proportions and with it The ilegx initiative, coated balloons, stent grafts, laser debulking The main challenge for drug-coated has come a growing launched in 2008, was and covered stents and angioplasty or a balloons is calcium due to the vessel resist- number of complex created in response to combination of some of these technologies. ance which results in early vessel recoil. If lower limb problems the increasing number More serious chronic ischaemia is associ- drug uptake is negatively affected is still including periph- of lower limb amputa- ated with below-the-knee arterial pathology unknown. Vessel preparation—either using eral arterial disease, tions which are mostly and for the first time at Charing Cross there plaque modulation or plaque removal— which is often accom- due to type II diabetes. will be a mini-symposium on wound heal- might be a method to improve drug-coated panied by a peripheral ilegx is a collaboration ing. “This mini-symposium will investigate balloon effectiveness in calcified lesions neuropathy. of like-minded health whether healing is entirely a matter of but this also increases treatment costs. The programme will also professionals, patients and control of diabetes and revascularisation include a session on the King’s care workers who share the view or if there are methods of encouraging Is there a consensus in College Hospital open access vascu- that too many legs are amputated and healing, which relate to none of the estab- relation to drug-coated lar diabetic foot care pathway. Michael many of these are completely unnecessary. lished accepted criteria such as increasing balloons vs. stents? Edmonds, course director, explains that it The ilegx mission is to attract attention blood flow,” comments Greenhalgh. No, there is no consensus yet. The provides open rapid access to accelerate and draw awareness to the need for an im- Vascular News spoke to Thomas interventional community is split into urgent assessment and to proceed quickly provement in healthcare in order to lower Zeller, Bad Krozingen, Germany, about stent believers, in particular in France, to state-of-the-art interventions, including unnecessary major amputation of legs. the highlights of this year’s CX Pe- where drug-coated balloons are not ripheral Arterial Main Programme. reimbursed, and a school of physi- cians who believe more in a strategy The CX Peripheral Arterial Abstract Presentation Sessions What are the most interesting of leaving nothing behind favouring Day will take place on Wednesday 27 April in the London Room, topics in the CX 2016 Periph- drug-coated balloons and atherec- and in the morning of Friday 29 April in the Lower Main eral Arterial Main Programme? tomy. In the end, cost-effectiveness 4 Auditorium. In my opinion, the most interesting will drive the choice of therapy.

4 Charing Cross Symposium March 2016 Mini-symposium explores false lumen CX Abstract Presentation Sessions challenges in acute and chronic type The first day of the CX Abstract Presentation Sessions Day (Tuesday 26 April) will focus on Aortic topics. In the morn- B dissection ing, Thoracic Aortic abstracts will be presented in the Lon- 1 don Room Learning Centre, and a dedicated session on 28 APRIL 2016 Abdominal Aortic abstracts will be held in the afternoon. Day UPPER MAIN AUDITORIUM

3 It is accepted that the Great Debate: “In chronic type the prognosis and B dissection, there is no place for outcomes of type B dissection are false lumen embolisation.” Peter more favourable if the false lumen Mossop (Melbourne, Australia) and is thrombosed. According to Roger Jonathan Sobocinski (Lille, France) Greenhalgh, chairman of the CX favour intervention in the true lumen Longest follow-up Programme Organising and they will be opposed by Tilo Board, this has been Kölbel (Hamburg, Germany) and taken by some Fabrizio Fanelli (Rome, Italy) who for EVAR to be vascular specialists are in favour of embolisation of to imply that the false lumen to thrombose it. the false lumen “The management of type B presented for the should be dissection has lingered with us for Aortic embolised, about five years. It will be interesting if it is not to see what the audience makes of first time at CX 2016 Challenges thrombosed, and this,” comments Greenhalgh. intervention will Another challenge when treating 27 APRIL 2016 provide a better thoracic aortic disease is the risk Day UPPER MAIN AUDITORIUM prognosis. “This is of operative death and spinal cord a very controversial ischaemia, and a session will be 2 Fifteen-year follow-up endovascular aneurysm area,” he says; dedicated to examining preventive of the Endovascular repair against open repair therefore, CX will hold a strategies. A mini-symposium will Aneurysm Repair (EVAR) 1 Trial for abdominal aortic aneurysms, mini-symposium on the topic. discuss radiation damage to the will be presented for the first time according to Greenhalgh. The mini-symposium, which is part pioneer endovascular operators, at CX 2016. The EVAR 1 Trial The meta-analysis of the four of the Thoracic Aortic Aneurysm and this will be followed by a was the first EVAR vs. open repair trials involves merging the data over Challenges Day, will conclude with session on juxta-renal challenges. abdominal aortic aneurysm trial the years of follow-up. “Putting to be conducted and is the first to the patient data from the four trials reach 15 years of follow-up. together increases the power for CX Aortic Edited Cases “This is certainly one of the key analysis and key lessons are learned topics to be from this study,” 28 APRIL 2016 presented at the comments LOWER MAIN AUDITORIUM CX Abdominal Greenhalgh, Aortic Aneurysm principal Challenges Day investigator of (Wednesday, the IPD meta- 27 April) of analysis. CX 2016,” The data from says Roger Roger Greenhalgh Jan Blankensteijn the EVAR 1 Greenhalgh, Trial (Roger chairman of the Greenhalgh), CX Programme DREAM (Jan Organising Blankensteijn), Board. ACE (Jean- The last Pierre EVAR 1 Trial Becquemin) follow-up—the and OVER 10-year follow- Jean-Pierre Frank Lederle (Frank Lederle) up—presented Becquemin were merged at at CX 2010 Imperial College in London, UK, and and published in The New England are being analysed at the University Journal of Medicine, demonstrated of Cambridge Statistical Unit. The CX Aortic Edited Cases will be a thoracic proximal scallop, and no significant differences between The Programme will also include used to explore the application of an aneurysm case treated with the endovascular aneurysm repair and a session on the relationship different techniques in complex thoracic Zenith Alpha Thoracic endograft. The open repair in terms of mortality. between lifestyle and abdominal aortic and abdominal aortic procedures abdominal session will include cases “This extra follow-up has been aortic aneurysm growth, discussing to achieve the best outcome for patients. with the EVO Endurant next generation performed in order to see what factors, including stress, that can The format includes short patient low-profile device, preoperative intent happened to that result out to 15 lead to aneurysm enlargement presentations, imaging and indications of use of the EndoAnchor for a short years. It is very important to know and eventual rupture. for the procedure, and allows the neck, the Incraft endograft, the Zenith how the methods have done in the The presenters and panel will also audience to question at every stage. Alpha Abdominal, EVAS with the Nellix long term,” notes Greenhalgh. look at the difficulties of population This year’s thoracic session will device, a case of infection control with Another highlight of the Abdominal screening projects, which remain a include cases with the TAG Thoracic open repair, and a case using Onyx Aortic Main Programme will be challenge for public health systems. Branch Endoprosthesis for the arch, embolisation for type II endoleaks. the presentation, for the first time, The Aortic Challenges Programme of an Individual Patient Data (IPD) will include the Great Debate event, meta-analysis of the EVAR vs. in which four expert speakers will One of the CX Abstract Presentation Sessions taking place open repair randomised controlled discuss the threshold for abdominal Day on the morning of Friday 29 April will include Aortic ab- trials—EVAR 1, DREAM, OVER aortic aneurysm intervention, and stracts in the Lower Main Auditorium. and ACE. The research will show whether it should be settled by 4 the “highest level of evidence” of randomised controlled trials. March 2016 Charing Cross Symposium 5 CX Venous Challenges session to Experience venous technologies and explore when to use and when not to use techniques in the CX Venous Workshop technologies in venous disease treatment 27 APRIL AND 28 APRIL 2016 Days GALLERY 26 APRIL 2016 Day LOWER MAIN AUDITORIUM 2-3 The CX Venous Workshop a good cosmetic result every time treating consists of one-to-one thread in discerning patients can be 1 For the first time, the most interesting areas are developments demonstrations by world-leading experts the hardest part of phlebological practice.” CX Venous Challenges in ageing clot so we can better select and expands on the technical aspects of He continues, “We are bringing some Main Programme will take place on the patients for lysis. In addition, there are a key superficial and deep venous topics techniques to expand the first day of the Symposium. The Venous number of areas of considerable debate discussed in the CX Venous Challenges aesthetic side rather than truncal venous Main Programme will be comple- principally around the concept of treat- Main Programme. This year, a new reflux. Two new laser stations using lasers mented by the CX Venous Workshop, ment of haemorrhoids with embolisation, section on aesthetic phlebology will in different ways will also be included.” which will run on days two and three. which need careful discussion.” be included in the workshop. Over two days, the workshop will “This new structure runs very nicely for Mark Whiteley (Guildford, Franklin comments: offer delegates open access to attend delegates who will have the opportunity UK), another member “The venous world various training stations at any time. to continue the discussion of the subjects of the CX Programme encompasses a wide Speaking on the additional highlights of this and techniques learned on the first day, Organising Board, variety of issues year’s workshop, Franklin says: “In 2016, on the second and third days in the CX considers that one of ranging from the CX Venous Workshop is not so much Venous Workshop, in small groups and the most interesting acute deep vein about new kit and new devices it is more face to face, with world-leading experts topics for discus- Venous thrombosis to about providing a better understanding of who will provide practical sessions on sion in the Venous severe chronic when to use and when not to use them and superficial and deep venous interventions,” Main Programme Challenges post thrombotic where they fit in the treatment of patients. says Ian Franklin (London, UK), member is the investigation syndrome and The ethos of the CX Venous Workshop is of the CX Programme Organising Board. and treatment of but trying to create a balance bringing together This year, the CX Venous Challenges pelvic veins and the there is also a practice everything that has a phlebological interest. Main Programme will explore the use associated deep veins. He in phlebology which is We try to be as inclusive as possible for of various technologies and techniques says: “Now, proven to be related to aesthetics. Getting individual and personalised practice.” for the treatment of superficial and deep associated with leg varicose veins venous disease, with emphasis on the in one in seven women, pelvic venous latest evidence of when and in which reflux should interest anyone practising patients they should be used. Franklin varicose vein surgery. However, pushing notes: “This year we are trying to focus not the envelope further, are Previn Diwakar only on the techniques but also on when (London, UK) presenting pelvic vein to use and when not to use them. We also reflux in males and David Beckett (Poole, want to encourage more discussion about UK), suggesting haemorrhoids are part which patients are the most appropriate of the pelvic venous reflux picture.” for which technology and technique.” Franklin, Black and Whiteley agree The topics for discussion will include that the new section on lymphoedema acute deep vein thrombosis and deep vein challenges is a great addition to the Ve- stenting challenges, followed by proxi- nous Programme in 2016. Alun Davies mal deep venous obstruction and pelvic (London, UK), member of the CX vein reflux challenges. A new session on Programme Organising Board, com- lymphoedema challenges will precede dis- ments: “Lymphoedema is one of the Hands-on learning at the CX Venous Workshop cussions on superficial venous challenges. Cinderella subjects of vascular disease. Franklin says that delegates will learn A large number of patients suffer from “Long-term data needed for deep venous a more integrated approach to venous this as a primary condition or secondary disease treatment. He notes: “There used to treatments. This area needs improve- disease treatment” to be a split between superficial venous ment in defining the disease process and issues and deep venous issues, without the evaluation of new technologies to deal Stephen Black (London, UK), member as developments in our understanding of understanding that there is a huge overlap. with the symptoms suffered by patients.” of the CX Programme Organising Board, and other adjunctive There are patients with symptoms, who we Franklin adds: “In the past, lymphoe- speaks about the current challenges in the techniques. I think we will see a big focus on have previously treated for superficial vein dema was probably neglected because treatment of deep venous disease, key lysis techniques in the next year as well as the issues and in fact they had an underly- people thought that there was not much developments in the field, and factors entry of new stents into the market. ing disease, which we never appreciated. that could be done about it. Now there are influencing outcomes in venous stenting. As data emerge for stenting in chronic As imaging and stenting techniques some quite exciting new developments, patients we have the challenge of dealing improve we now have potential to get which may change that perception. Some What are the major challenges with both early stent occlusion and later much better results in these patients.” of them are variations of existing treat- treating deep venous disease? restenosis. Very rarely this is a problem Stephen Black (London, UK), also a ment and some are new techniques. We We need to improve our data on deep venous with the stent—apart from technical issues member of the will explore those disease treatment, particularly regarding long- usually relating to poor deployment—so CX Programme developments at term outcomes and patient selection. Patency our challenge is to understand the factors Organising Board, Charing Cross.” alone is not good enough. We also need to impacting thrombus formation and flow in adds: “This year The CX Venous focus on the significance of the problems that stents. Particularly, flow is hard to measure we will see data to Abstract Presenta- post-thrombotic syndrome causes in quality of before and after stent treatment and ap- be presented on the tions are also an life and work out how to best represent this. pears to be a very significant component of first investigational important addition why stents fail. Managing clotting is also device exemption to the Venous Are there any key developments complex. I am sure we will see advances studies conducted Ian Franklin Stephen Black Programme. in the deep venous field? in stent design but we need to remember for the dedicated Black comments: Yes. We are seeing for the first time data that the stent is only one component of venous stents as “The abstracts presented on the new venous stents as well successful treatment. well as a number complement the of new develop- Main Programme ments in clot lysis and should allow The CX Venous Abstract Presentations will take place in the and mechanical for stimulating Day morning of Friday 29 April in the London Room Learning thrombectomy. I discussion of a Centre. believe, however, number of con- 4 that some of the Mark Whiteley Alun Davies troversial areas.” 6 Charing Cross Symposium March 2016

The CX Acute Stroke Abstract Presentations Day will take place in the afternoon of Thursday 28 Insights into acute 3 April in the Olympia Room Learning Centre. stroke challenges

Ross Naylor (Leicester, UK), member of the CX Programme Organising Board, discusses the biggest challenges of Debut of the new Acute treating acute stroke, the role of a multidisciplinary team in this setting and the highlights of the CX Acute Stroke Challenges session Stroke Challenges What do you think are the will explore the statement biggest challenges treating “Only neuroradiologists Programme acute stroke? should undertake intra-arterial Improving patient thrombectomy”; what are your 29 APRIL 2016 awareness about the views with regards to this Day UPPER MAIN AUDITORIUM need to seek urgent practice? medical advice as As with many other aspects of 4 On 29 April approach such that soon as transient endovascular care, it is more 2016, the Charing unwanted emboli Acute ischaemic attack important that our patients have Cross Symposium will hold to the brain can or stroke-like rapid access to a trained and Acute Stroke Challenges, a new be managed by Stroke symptoms experienced practitioner, rather educational, multidisciplinary clot retrieval, and happen; than the specialty badge he or she Programme directed by Ross to encourage the Challenges persuading wears. Rotas for providing acute Naylor (Leicester, UK) and optimisation of health systems intracranial thrombus retrieval will Martin Brown (London, UK). referral so that stroke of the importance be quite onerous and will require Discussing the rationale for patients reach the best of setting up 24-hour service delivery. The more incorporating this session at hands as fast as possible. dedicated daily qualified and experienced people this year’s Symposium, Roger The latest technology to cerebrovascular clinics that can join these rotas the better. Greenhalgh, chairman of the CX arise has been the stent retriever, for ensuring the rapid treatment Programme Organising Board, says: now in use in acute stroke units. of transient ischaemic attack patients What is the rationale for the “The realisation that a number of The Programme will explore and convincing hospitals of the need addition of the CX Acute strokes are caused by interventions different aspects of intracranial to have 24/7 access to interventional Stroke Challenges at the 2016 in the aorta and manipulations clot retrieval, including patient services who can perform intracranial Symposium? in the arch has led to the birth of selection and current therapies, thrombectomy and/or for ensuring that For too long, stroke has been the the new Acute Stroke Challenges and an overview of the main trials triage systems exist to enable rapid ‘poor relation’ when compared with Programme, a natural extension of in the field will be discussed. patient transfer to centres that can. the much greater emphasis placed on the Charing Cross Symposium.” The Programme will also cardiological interventions and endo- The half-day Programme introduces feature a selection of strategies What is the current role of vascular treatment of aortic patholo- a multidisciplinary approach to acute for intervention including the a multidisciplinary team in gies. Yet, there are important advances stroke challenges. This is a logical role of imaging for acute stroke treating acute stroke? happening all the time in the field of extension of the endovascular arterial patients and an algorithm of care As we move towards ultra-rapid stroke prevention and its acute treat- world as many of the cerebral emboli or “stroke workflow”, followed by treatment of patients with stroke ment, which affect a lot of medical are being triggered by catheterisation presentations on the current role (and transient ischaemic attack), it specialties. It is rare for experts from of the aortic arch associated with heart of urgent carotid is no longer appropriate to rely on , interventional radiol- valve replacement or manipulations and . the traditional weekly carotid/stroke ogy, neurointerventional radiology, of the great vessels. In an era when The purpose of the Acute Stroke multidisciplinary team, as most neurology and cardiology to be able the whole of the aorta can be replaced Challenges Main Programme, interventions are now carried out as to meet and participate in a dedicated by endovascular techniques, more Greenhalgh comments, “is to emergency or as semi-urgent procedures. Acute Stroke Challenges session to de- and more catheterisation of the arch encourage a multidisciplinary This will still require specialties to bate and discuss all the latest evidence of the aorta is expected, and with approach such that unwanted emboli consult and aid each other, but this will and innovations. Fortunately, CX will it, more cerebral emboli with awful to the brain can be managed by probably now be on a less rigid basis. offer that opportunity. outcomes. The purpose of the Acute clot retrieval, and to encourage The key is to develop guidelines for Stroke Challenges Main Programme the optimisation of referral so ensuring that patients have rapid access What will be covered at the and Abstract Presentation sessions that stroke patients reach the best to collaborating specialties, rather than CX Acute Stroke Challenges is to encourage a multidisciplinary hands as fast as possible.” turf wars over who should be doing session? what. There is still a lesser role for We will be covering everything from the traditional multidisciplinary team, identifying the high-risk carotid but this will be for the more complex plaque, through access to urgent semi-elective cases which do not require stenting and emergency or urgent interventions. in the hyper-acute period after onset of symptoms, modern medical How can physicians who therapy strategies, dual antiplatelet intervene in the aorta, aortic strategies during carotid surgery, arch and carotid arteries work emergency endarterectomy for together with stroke specialists progressing stroke, the various to improve stroke rates and strategies available for intracranial outcomes? clot retrieval and a debate about who By attending the Charing Cross should be performing intracranial Symposium to see how interdisciplinary thrombectomy. The day concludes collaboration and knowledge of the with a series of talks on strategies latest technologies can help them for reducing arch embolisation avoid a potentially devastating during thoracic endovascular complication like stroke. procedures, as well as other techniques for reducing the overall A debate at the CX Acute burden of cerebral embolisation Ross Naylor Martin Brown Stroke Challenges session during various arch interventions.

8 Charing Cross Symposium March 2016 New CX Vascular Access Course

The CX Vascular Access Course will provide both experts and those new to the field with invaluable insights into the challenges currently facing haemodialysis vascular access, and the methods used to overcome them. The three-day Course will bring together world experts to cover current practice and remaining challenges. Course directors Domenico Valenti and Nicholas Inston speak about the focus of the course.

What are the current particularly when maturation failure rates challenges in the treatment are high. Adjuncts to improve primary of patients with kidney failure patency and prevent the formation of requiring vascular access? neointimal hyperplasia would be a major There are a number of significant chal- advance in the field with direct benefit to Domenico Valenti Nicholas Inston lenges. The first is timely identification patients. and referral of patients who require What new technologies will be forward to seeing at the CX access. Those patients who start dialysis What are the current challenges discussed in the course? Vascular Access Skills Course? on a CVC (line) have much lower rates in treating steal syndrome? The rapidly evolving technological Ultrasound assessment is always popular, of definitive access than those who Treatments to maintain vascular access field of vascular access encompasses and it is always good to pick up tricks have been referred to a surgeon prior patency whilst avoiding distal ischaemia diagnostic and interventional devices. from world experts. The benefit of the to dialysis initiation. Once a patient is are challenging. Preoperative prediction of World experts in the areas of imaging, skills course is that the demonstrators can referred, the most common choice of steal syndrome (or haemodialysis access- surgery and explain why they do something. access appears to be guideline-driven, induced distal ischaemia—HAIDI), will be assembled to discuss multiple which may not suit many patient groups. diagnosis and specific treatment are technologies such as grafts, stents and The presentation of vascular The individual tailoring of access appears again driven by poor data. Further good even non-surgical arteriovenous fistulae access abstracts is scheduled to be key to success and a pure guideline quality studies based on standardised creation. for Friday 29 April. What is based “fistula first in a distal position” is classifications are required, particularly your opinion about this year’s challenged by many experts in the field. longitudinal observational studies to On the second day (28 April), abstracts? In maintaining patency and longev- define the natural history of HAIDI and participants will take part in The volume of high quality abstracts ity in fistulae and grafts the key role of outcomes of treatment. a skills course. What are the submitted confirms a growing interest from multidisciplinary care—between dialysis benefits of having a practical both trainees and established surgeons nurses, nephrologists, surgeons and This year CX delegates will session on vascular access? in the field. Many questions still remain interventional radiologists—is becoming experience a new Vascular The addition of a hands-on course is in haemodialysis vascular access and the better appreciated and the application of Access Course, with activities intended to give delegates the ability research submitted aims to answer many technological innovations is increasing. over three days. What will to gain practical skills and be tutored of these. The session will be thought- With increased application the evidence participants learn on the first day through the many techniques involved provoking and should promote debate. base is often poor and expensive invasive of the course (27 April)? in vascular access. As it covers the techniques are difficult to compare due to By assembling a faculty of world whole spectrum of vascular access it is Wednesday 27 April lack of quality trials. experts and in conjunction with audience suitable for those new to access as well (Pillar Hall Learning The lack of any useful pharmacologi- interaction, we expect to not only cover as those with expertise. Centre), Thursday 28 April cal treatments for arteriovenous fistu- the current state-of-the-art practice in the (Exhibition Hall) and Friday lae, either at the time of creation or to area but also define the evidence gaps that Could you please highlight some 29 April (Pillar Hall Learning maintain patency, is a major concern, require further study. of the stations you are looking Centre) Innovators to showcase fresh approaches to vascular and endovascular challenges The CX Innovation Showcase provides a platform for the latest vascular and Vascular bioresorbable stent programme. endovascular technologies, and is geared towards encouraging physician-inventors to In the Innovation Showcase, budding physician- share their work with a wide range of industry experts, investors, start-up companies inventors will get the chance to hear from and interact and fellow inventors. The session will be held on Wednesday 27 April in the Olympia with experienced field leaders. Speakers will offer Room with course directors Stephen Greenhalgh and Andrew Holden. advice on a range of vital topics, including how to secure funding for a new device, how registry data he thoracic aortic section of the Showcase will can assist a device approval and common pitfalls that include new software for the measurement of physician-inventors should work to avoid. Tthe inside of the curve aortic disease (En- dologix), data on the early experience with a surgeon- Dragons’ Den 2016 modified and simplified thoracic abdominal aortic Several physician-inventors will then showcase their aneurysm device (Medtronic) and off-label use of the innovative vascular and endovascular ideas/projects Amplatzer vascular plug II (St Jude Medical) to seal to a panel of “Dragons” in the Dragons’ Den session. s m a l l c h r o n i c d i s s e c t i o n e n t r i e s i n t h e a r c h . The panel will include Bob Mitchell, Daveen In the abdominal aortic part of the programme, Chopra, Jason Field and Chas Taylor. The winner of delegates will hear about advances in in vivo the 2015 CX Innovation prize was Jeffrey Lawson fenestration technology, the latest 3D-printed (Durham, USA), for his dialysis graft technology, aortic models for FEVAR and will be given an which is designed to protect patients when their overall review of the Zenith Alpha (Cook Medical) dialysis graft needs to be cannulised with a sharp technology. needle. Commenting on the value of the Dragons’ Those attendees interested in peripheral innovation Den session, Lawson said: “It is a wonderful will hear updates on several nascent technologies, opportunity, and it is fun. It is also really good to including the Chocolate drug-coated balloon see other people’s technology making progress.” (Trireme Medical), the Everflex self-expanding stent (Freedom Trial; Medtronic), the Zilver PTX stent Wednesday 27 April – Olympia Room (ZILVERPASS trial; Cook Medical) and the Abbott Stephen Greenhalgh with 2015 winner Jeffrey Lawson Learning Centre

10 Charing Cross Symposium March 2016 CX Abstracts Sessions to showcase upcoming talents

In the CX Abstract Presentation Sessions, clinicians—both junior and senior—will present their latest research to leaders in the vascular and endovascular fields. The CX Tuesday 26 April Abstract Presentation Sessions are a platform for spotting and promoting new talent, Thoracic Aortic – London Room (morning) providing an opportunity to recognise upcoming key opinion leaders who could become Abdominal Aortic – London Room (after- part of the CX Faculty in the future. noon)

he CX Abstract Board and CX Programme the course of the Symposium. Wednesday 27 April Organising Board have selected and accepted over All abstracts selected for presentation have Peripheral Arterial – London Room T190 abstracts and nearly 30 posters to be included. been included in the CX Abstract Book. The best The Abstract Sessions have been spread across all presentation from each of the two categories Thursday 28 April four days of the Symposium and divided into themed (junior and senior) will be awarded a £1,000 prize Imaging – Olympia Room (morning) sessions: abdominal aortic aneurysm, thoracic aortic, and a diploma for best presentations. The prize Acute Stroke – Olympia Room (afternoon) venous, peripheral arterial, and acute stroke. The winners and holders of certificates of merit will be sessions will take place in the CX Learning Centres. invited to suggest a presentation topic for the 2017 Friday 29 April Two more themes—vascular access and imaging— Charing Cross Symposium Main Programme. Aortic/Peripheral – Lower Main Auditorium have been added to the Abstract Presentations, and The CX Abstract Board will be co-chaired by (morning) will take place as part of the CX Vascular Access Ian Loftus and Richard Gibbs. The other members Vascular Access – Pillar Hall (morning) Course and CX Imaging Day, respectively. of the Board are Paul Hayes, Robert Hinchliffe, Venous – London Room (morning) The selected poster presentations will be Colin Bicknell, Daryl Baker, Rachel Bell, Marcus displayed in the Exhibition Hall throughout Brooks, Meryl Davies and Simon Ashley. CX Imaging Day to highlight CX Vascular Malformations state-of-the-art technology Management The use and development of is vital in he 2016 CX Vascular Malfor- encouraging the continued success of endovascular mations Management session, intervention. At the CX Imaging Day, delegates will hear about Tled by Iris Baumgartner, Bern, the latest data and innovations in the field of vascular imaging, Switzerland, will provide attendees with a programme covering a wide range of peripheral arterial, with an overview of congenital vas- venous and aortic topics. cular malformations, which will be of benefit to general vascular specialists. he peripheral arterial imaging The session will cover a range of topics, session will include technologies including diagnostic imaging principles, Tfrom Siemens, GE and Hansen, venous malformations, Klippel-Trenaunay looking at CO2 imaging, the value of Syndrome, arteriovenous malformations fusion imaging in treating complex and vascular malformations in children. Iris Baumgartner aortoiliac occlusions and how robotics Each of the session’s talks will be and 3D imaging can improve proce- followed by case presentations in an discuss the current challenges facing the dural success in complex pathologies. interactive discussion format, giving treatment of vascular malformations. Robotics will be the focus of the delegates the opportunity to directly venous imaging session as speakers interact with the expert speakers (Joe Tuesday 26 April (morning) explore the use of robotic technology Brookes, Andreas Saleh, Matthias – Olympia Room Learning in the failed treatment of central venous Widmer and Walter Wohlgemuth) and Centre stenosis and the removal of IVC filters. Koen Deloose The potential of robotic technol- ogy will also be discussed in the aortic imaging session, along with other topics CX Paediatric Vascular Issues including integrated planning for EVAR, Complementing the CX Vascular the use of cone beam CT with fusion Malformations session, the CX Paediatric technologies to minimise radiation use Vascular Issues session will focus on and the prevention of contrast induced conditions including congenital vascular nephrotoxicity in vascular procedures. abnormalities. George Hamilton, London, These three sessions will be chaired by UK, and Malcolm Simms, Birmingham, Tara Mastracci (London, UK) and Frank UK, are the course directors. Veith (New York, USA), and each section This year, the session will address will conclude with a panel discussion, issues related to imaging, and acute involving the chairs and the speakers. ischaemia pre-term, in neonates and in Following this, Stéphan Haulon children. This will be followed by presen- (Lille, France) and Richard McWil- Stéphan Haulon tations on chronic ischaemia and arterial George Hamilton liams (Liverpool, UK) will chair an pathologies. The discussion of venous abstract session of imaging presentations. their everyday practice, and showing how pathologies and malformations will close A discussion will follow each of the this can improve clinical outcomes. The the session. presentations, giving attendees the chance first, led by Haulon, will look at integrated For this year’s course the directors have to interact with the expert speakers. planning and endograft sizing using new invited the submission of paediatric vascu- In the afternoon, the focus will switch to EVAR ASSIST. The second, led by Deloose, lar cases concerning acute or chronic limb the Exhibition Hall, where delegates can will focus on preoperative planning and ischaemia, trauma, mid-aortic syndrome, see imaging technology from Siemens and fusion guidance for lower limb occlusions cancer resection and vascular malforma- GE first hand and speak with expert users. using the new Vessel ASSIST system. tions. These cases will be used to encour- Koen Deloose (Dendermonde, Belgium), age audience discussion. Stéphan Haulon (Lille, France), and Robert Thursday 28 April – Olympia Rhee (New York ,USA) will then lead three Room Learning Centre Tuesday 26 April (afternoon) – imaging workshops, discussing their new (morning) and Exhibition Hall Olympia Room Learning Centre Malcolm Simms ASSIST “Plan, guide and assess” tools in (afternoon)

12 Charing Cross Symposium floorplan March 2016 CX 2016 floorplan ar a ar r

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Pavilion Sponsors Exhibitors 442 Abbott Vascular 514 Alma Surgical 610 LINC 308 Spectranetics

229 Boston Scientific 302 Angiodroid 402 LSO MEDICAL 306 St Jude Medical 140/141/131 Cook 641 Argon Medical Devices 419 Mentice 307 TeraRecon 448/642 Cordis 150/151 Endologix 237 BARD 233 Merit Medical 506 TVA Medical 250/260 Gore 203 BIBA Medtech Insights 405 NeoLaser 508 Vascular Insights 430/ 638 Lombard 415 BTG 204 Olympus Surgical Technologies Europe 203 Vascular News 170 MAQUET GETINGE GROUP 470/450 Medtronic 614 F Care Systems 310 optimed 405 Veniti 240 Vascutek 405 Frontière Médicale 207 OSCOR 512 Veryan Medical

219 GE Healthcare 407 Penumbra 405 Walk Vascular Major Sponsors 318 Bentley 215 Hansen Medical 305 Perouse Medical 309 Ziehm Imaging 218 Bolton Medical 639 IDEAS 400 Philips Volcano 518 3D Systems, Healthcare 319 Cardionovum 208 JOTEC 405 RF Medical 134 INVAMED 420 Siemens 608 Laminate 404 Scanlan International 421 Straub Medical 209 LeMaitre Vascular 403 Shockwave Medical

Pillar Hall Upper Main Learning Centre Auditorium Olympia Room Learning Centre

Lower Main Auditorium

Speaker ready Room and Invited Faculty Lounge

London Room Learning Centre Entrance March 2016 CX Sponsors 13 CX 2016 Pavilion and Major Sponsors

PAVILION SPONSORS MAJOR SPONSORS

Abbott Vascular worldwide. Bentley Innomed latest innovations with highest patient Booth 442 goremedical.com/eu Booth 318 safety guarantee. When it comes to delivering innovative Bentley offers innovative solutions cardionovum.eu solutions to the people that we serve, we Lombard Medical for minimally invasive coronary and explore every path to a breakthrough. Booths 430, 638 peripheral vascular therapies to doctors, Invamed This means employing a diverse body of Lombard Medical, Inc is a leading patients and business partners around Booth 134 people across widespread geographies global, innovative company that is ex- the world. Core competence is the Invamed is dedicated to continuous innova- with the most powerful technologies. The panding the EVAR treatable population development of covered and uncovered tion in order to shape everything we do. Our result is an enduring impact on people in with our portfolio of patient focused stents. The BeGraft peripheral, BeGraft purpose is to improve health of the patients their pursuit of healthy lives. technologies and customer support. Aor- aortic, BeSmooth and BeGraft coronary all around the world with our strong, hard www.abbottvascular.com fix is an established endovascular stent constitute the ambitious beginning of an working, dedicated and clinically driven graft specifically designed for flexibil- extensive product pipeline. biomedical solutions team. Our products Boston Scientific ity and conformity in difficult to treat www.bentley.global and technologies are mostly focused on en- Booth 229 AAA anatomies, including aortic neck dovascular treatment solutions with addition Boston Scientific transforms lives through angulation up to 90 degrees. Our latest Bolton Medical of wide range of medical conditions. innovative medical solutions that improve Altura endograft system’s revolution- Booth 218 www.invamed.net the health of patients around the world. As a ary 14F ultra low profile design offers Bolton Medical is a subsidiary of the global medical technology leader for more extraordinary advantages including no WerfenLife Company. WerfenLife is Siemens than 35 years, we advance science for life by cannulation, unique seal and reposi- a global company that manufactures Booth 420 providing a broad range of high perfor- tionability for a simple and predictable and distributes medical diagnostic Siemens Healthcare is one of the mance solutions that address unmet patient solution for treatment of more standard solutions and medical devices world’s largest suppliers of technology needs and reduce the cost of healthcare. AAA anatomies. worldwide. Bolton Medical’s vision to the healthcare industry and a leader in www.bostonscientific.eu www.lombardmedical.com is to become the leading provider medical imaging, laboratory diagnostics of endovascular solutions for aortic and healthcare IT. All supported by Cook Medical MAQUET GETINGE GROUP disease. Headquartered in the US, a comprehensive portfolio of clinical Booths 140, 141, 131 Booth 170 Bolton Medical improves the quality consulting, training, and services Cook Medical is the world’s largest Getinge Group is a leading global and safety in patient care by developing, available across the globe and tailored privately held developer and manufacturer provider of products and systems that manufacturing, and distributing to customers’ needs. of minimally invasive medical device contribute to quality enhancement and innovative, high quality products and www.healthcare.siemens.com technology. A leader in the advancement of cost efficiency within healthcare and technology solely focused on the aorta. diagnostic and therapeutic products for vas- life sciences. We operate under the www.boltonmedical.com Straub Medical cular disease, Cook continues a tradition of three brands of ArjoHuntleigh, Getinge Booth 421 innovation with comprehensive device of- and Maquet. Maquet specialises in Cardionovum Straub Medical AG is a leading ferings in EVAR, leg therapies, pulmonary solutions, therapies and products for Booth 319 developer and manufacturer of embolism prevention and embolisation. surgical interventions, interventional Cardionovum GmbH is a leading medical devices and is dedicated to www.cookmedical.com cardiology and intensive care. company in innovative coronary and the innovative and rapid development www.maquet.com peripheral drug coating technologies of relevant and unique products in Cordis improving clinical outcomes and qual- the field of endovascular therapy. Booths 448, 642 Medtronic ity of life. LEGFLOW® drug coated The Straub Endovascular System for Cordis, a Cardinal Health company, is Booths 470, 450 balloon for peripheral artery disease mechanical debulking detaches and a worldwide leader in developing and As a global leader in medical treatment as well as APERTO® Drug removes occlusive material from blood marketing innovative solutions and de- technology, services and solutions, coated balloon for haemodialysis shunt vessels safely, rapidly and in a cost- vices for cardiovascular disease manage- Medtronic improves the lives and treatment and RESTORE® for coro- effective manner. ment. Cordis is committed to deliver the health of millions of people each year. nary artery disease treatment are the www.straubmedical.com right combination of solutions, products, We use our deep clinical, therapeutic, services and evidence to treat millions of and economic expertise to address patients who suffer from vascular disease. the complex challenges faced by www.cordis.com healthcare systems today. Let’s take healthcare Further, Together. Visit Endologix www.medtronic.com and come to our Booths 150, 151 booths 450 and 470 to learn more about Endologix is uniquely positioned to offer our latest solutions and therapies to vascular specialists the range of AAA treat vascular disease patients. products and services they need to confi- www.medtronic.com dently treat more patients more effectively. Designed around key challenges including Vascutek access, challenging anatomies and aneu- Booth 240 rysm sealing, our products have delivered VASCUTEK, a TERUMO Company is excellent patient outcomes. When it comes a world leader in the design and manu- to ensuring patient wellbeing, we are never facture of products that address the satisfied with the status quo. needs of vascular and cardiovascular www.endologix.com clinicians. For over 30 years, Vascutek has applied advanced and innova- Gore Medical tive technologies to develop a wide Booths 250, 260 portfolio of products for peripheral, At Gore Medical, we have provided abdominal and cardiothoracic surgery. creative therapeutic solutions to complex These include the Anaconda™ AAA medical problems for 40 years. During stent graft system, custom Fenestrated that time, 40 million innovative Gore Anaconda™ and the Thoraflex™ Hy- Medical Devices have been implanted, brid FET device. saving and improving the quality of lives www.vascutek.com 14 CX Exhibitors March 2016 CX 2016 exhibitors Alma Surgical and VascuLife BIBA MedTech Insights Hansen Medical vascular, cardiovascular and peripheral Booth 514 Booth 203 Booth 215 vascular disciplines. Mentice’s exper- Alma Surgical, a division of Alma BIBA is a leading provider of market Hansen Medical®’s Magellan™ Robotic tise is represented in clinically relevant Lasers, is changing the endovenous analysis services. We serve medical System is intended to be used to facili- medical endovascular scenarios laser treatment standard with Vascu- professionals and organisations in the tate navigation in the peripheral vascula- through high fidelity simulation. This Life™—the only minimally-invasive medical device industry in Europe and ture and subsequently provide a conduit realistic training permits transfer of with robotic pullback solution. Vascu- in North America. Our research products for manual placement of therapeutic skills and knowledge in a reproducible, Life features a 1470nm diode laser and include quarterly monitors, customised devices. The Magellan Robotic System safe and measurable way, benefiting radial emitting fibre as well as a full research and tailored services. is designed to deliver predictability, clinical teams and patients. visualization with the robotic fibre pull- www.bibamedtech.com control and stability to endo- www.mentice.com back system—for complete and accurate vascular procedures. Since its commer- treatment of great and small saphenous BTG cial introduction, it has demonstrated Merit Medical veins (GVS, SSV). Booth 415 clinical versatility in a broad variety of Booth 233 www.almasurgical.com At BTG we are focused on bringing to peripheral vascular procedures globally. Merit Medical® offers an integrated market innovative products in specialist www.hansenmedical.com portfolio of products designed Angiodroid areas of medicine to better serve to support your vascular surgery Booth 302 doctors and patients. Our growing JOTEC procedures, dialysis, peripheral Angiodroid Srl is an Italian innovative portfolio of Interventional Medicine Booth 208 vascular interventions, interventional company that projects and trades solu- products is designed to advance the JOTEC develops, manufactures and radiology and cardiology. Discover the tions for the medical market. ANGIO- treatment of liver tumours, advanced markets medical devices for vascular HeRO®Graft, a fully subcutaneous DROID® “The CO2 Injector” is our emphysema, severe blood clots, and disease from the aortic arch down AV access solution, clinically proven main product and it is a carbon dioxide varicose veins, while our Specialty to the peripheral vessels: Discover to maintain long-term access for (CO2) injector for interventional Pharmaceuticals portfolio offers our extensive range of endovascular haemodialysis patients suffering of radiology procedures. ANGIODROID® antidotes that alleviate toxicity and standard products as well as our central venous stenosis. is 100% automatic, 100% safe, 100% treat rare conditions. tailor-made solutions. We can meet www.merit.com digital and 100% user-friendly. www.btgplc.com all your needs always aiming to offer angiodroid.com best possible solutions for patient’s NeoLaser F Care Systems treatment. Booth 405 Argon Medical Devices Booth 614 www.jotec.com The World’s Smallest Endovascular Booth 641 F Care Systems will be presenting the Laser. The neoV1470 is a superb micro- Founded in 1972, Argon Medical new and improved EVRF II (Endovenous Laminate surgical instrument for endovenous laser Devices manufactures medical products Radiofrequency) device for the treatment Booth 608 ablation of veins, as well as for incision and devices for interventional radiol- of saphenous veins, thread veins, Laminate Medical Technologies is and excision of soft tissue in critical ogy, vascular surgery, interventional perforating veins and spider veins, developing a new, external support areas. The peak of water absorption at cardiology, critical care, and oncology supported by the latest clinical trial with device for AV fistulas, to be implanted 1470nm enables precise cutting with procedures worldwide. Through a net- three-year data on over 600 saphenous during the fistula creation surgical good coagulation of soft tissue. As a work of direct sales representatives and treatments using our CR45i catheter. procedure. The device aims to drive a result of this unique tissue absorption, premier distributors, Argon supplies We are delighted to be presenting our change in the vascular procedures can be completed at lower physician customers with breakthrough new HPR45i probe for the low-cost, access treatment paradigm and bring energy dosages leading to less thermal technologies to improve clinical ef- safe and effective outpatient treatment about a significant reduction in the trauma and better healing. ficiency and outcomes. The Argon vas- for all grades of haemorrhoids, which annual fistula failure rate. cular product portfolio is highlighted we believe shall revolutionise the www.laminatemedical.com Olympus Surgical by the Option™ELITE retrievable IVC haemorrhoid treatment market. Technologies Europe Filter, Atrieve™ Vascular Snare and www.fcaresystems.com LeMaitre Vascular Booth 204 Cleaner™, the only wall-contacting Booth 209 Olympus is transforming the future of Rotational Thrombectomy System Frontière Médicale LeMaitre Vascular is a leading global healthcare by developing innovative indicated for use in the peripheral Booth 405 provider of innovative devices for the less invasive treatments. The unique vasculature! Frontière Médicale EUROPE is the treatment of peripheral vascular disease. bipolar radiofrequency-induced www.argonmedical.eu.com leader in commercialisation of Vascular We develop, manufacture, and market thermotherapy (RFITT) technology Treatment Technologies. disposable and implantable vascular devices represents an effective, user-friendly Bard Please visit to learn about our Deep- to address the needs of vascular surgeons and safe alternative to conventional Booth 237 Venous Portfolio; Veniti VICI, and the and interventionalists. Our diversified methods to treat varicose veins. Bard Peripheral Vascular, Inc. has a Clear Lumen thrombectomy device. Our product portfolio consists of well-known This localized and precise application tradition of vascular innovation with Superficial-Venous portfolio includes brand name products used in arteries and shrinks and occludes the vein in a focus on improving the quality of VeinCLEAR RFA , 1470nm veins outside of the heart. minutes. The treated vein remains in patients’ lives. It provides a range of neoLaser, and VariCLOSE. At CX2016 www.lemaitre.com the body and is no longer visible. interventional and surgical medical we will be launching the STENTYS DES www.olympus-europe.com devices for the treatment of peripheral for BTK treatment. LSO MEDICAL vascular, venous, dialysis access, biliary www.frontmed.org Booth 402 optimed and tracheobroncheal disease. Featured Based in Lille, France, LSO Medical is a Booth 310 Interventional products include the GE Healthcare leading manufacturer for producing innova- optimed is a German medical device Lutonix® Paclitaxel Coated PTA Bal- Booth 219 tive technologies, based on medical lasers. company dedicated to development loon Catheter, the LifeStent® Vascular GE Healthcare provides medical Vascular division focuses on EVLT systems: and production of products for Stent Systems – available in lengths up technologies and services to help the ENDOTHERME 1470 diode laser and minimally invasive vascular therapy. to 250mm, Lifestream™ Balloon Ex- solve the challenges facing healthcare the RINGLIGHT radial fibres, in 600μm As a constant leader in innovation, pandable Vascular Covered Stentgraft, providers around the world. From and 400μm sizes. LSO Medical offers also optimed continuously introduces VascuTrak™ PTA Dilatation Catheter, medical imaging, software, patient the EXOTHERME transcutaneous Laser in- unique products, such as the first Ultraverse® 014, 018 and 035 PTA monitoring and diagnostics, to cluding unique video handpiece, and cooling oblique venous stent “sinus-Obliquus”. Dilatation Catheters, Rival® PTA Dila- biopharmaceutical manufacturing system, for telangiectasias treatment. High-tech materials combined with tation Catheter and a range of unique technologies, GE Healthcare solutions www.LSOmedical.com high-precision manufacturing processes tools for crossing chronic total occlu- are designed to help healthcare ensure an outstanding product quality. sions with the Crosser® CTO Recanali- professionals deliver better, more Mentice Our portfolio includes self-expanding zation Catheter and Seeker® Crossing efficient and more effective outcomes Booth 419 nitinol stents, the CO2-Angioset and Support Catheter. for more patients. Mentice is world leader in endovascu- accessories for vascular interventions. www.bardpv.com www.gehealthcare.com lar training solutions covering neuro- www.opti-med.de

16 CX Exhibitors March 2016 CX 2016 exhibitors OSCOR ment of Chronic Venous Insufficiency. patient outcomes and providing cost sav- treatment of venous disease through Booth 207 VeinCLEAR is available in 5-element ing opportunities. Our Vascular portfolio innovative technology and solutions. Oscor US manufacturer of specialized lengths (1.0cm–7.0cm). The largest includes guidewires, Hemostasis Man- VENITI’s first product, the VICI catheters, introducer kits, steerable portfolio of all companies, and with agement, Intravascular diagnostics and VENOUS STENT®, was designed guiding sheaths & diagnostic products. clinical results of 97.4% success, Vein- imaging, peripheral vascular emboliza- specifically to meet the challenges of the Newly FDA & CE mark released CLEAR is the new leader in endother- tion, Renal Denervation, Bipolar Pacing venous system and needs of physicians steerable guiding sheath, Destino™ mal treatment of CVI. catheters and Vascular access. treating patients suffering from venous Twist & Destino™ Magnum, 180⁰ www.stjudemedical.com outflow obstruction. deflectable distal tip section. Also Scanlan International, Inc www.veniti.com on display Adelante® Radial Access Booth 404 TeraRecon Introducer system kit, newest Highest quality surgical products Booth 307 Veryan Medical Ltd technology for radial access. designed and manufactured by the TeraRecon is the largest independent, Booth 512 www.oscor.com Scanlan family since 1921. Over 3,000 vendor neutral medical image Veryan Medical Ltd. (Horsham, UK) instrumentation designs in titanium viewing solution provider with a has designed, patented and developed Penumbra and stainless steel including Scanlan® focus on advanced cardiovascular BioMimics 3D™, a unique and Booth 407 LEGACY titanium forceps and needle and interventional image processing highly innovative three-dimensional, Penumbra is a specialty interventional holders, SCANLAN® Super Cut™ innovation. TeraRecon’s iNtuition biomimetic, self-expanding, therapies company that develops and scissors, reusable Heifetz™ and and iNteract+ solutions advance the nitinol stent for the treatment of markets innovative medical devices to Yasargil clips. Single-use products accessibility, performance, clinical femoropopliteal arteries. BioMimics treat challenging medical conditions including Scanlan® VASCU- functionality and medical imaging 3D was shown to have significantly with significant unmet clinical needs. STATT® bulldog clamps and Vascular workflow throughout many areas of the better clinical performance when We design our therapies to provide Tunneling System. healthcare ecosystem. compared to a straight control in the our specialist physician customers www.scanlaninternational.com www.terarecon.com Mimics randomised study. with improved clinical outcomes www.veryanmed.com through faster and safer procedures at Shockwave Medical TVA Medical significant overall cost savings to the Booth 403 Booth 506 Walk Vascular healthcare system. Today we have sales Shockwave Medical is pioneering TVA Medical, Inc. is developing Booth 405 operations in North America, Europe, Lithoplasty® technology, a promising minimally invasive therapies for end- Walk Vascular’s ClearLumen Australia and Asia. breakthrough for the treatment of stage renal disease, including a catheter- Thrombectomy System breaks-up and www.penumbrainc.com peripheral and coronary vascular based arteriovenous (AV) fistula system. removes thrombus from the peripheral disease and aortic stenosis. Delivered The everlinQTM endoAVF System vasculature, incorporating a novel Perouse Medical on a standard balloon catheter creates an AV fistula for hemodialysis internal jet technology that macerates/ Booth 305 platform, Lithoplasty combines access using an endovascular approach. lubricates proximally flowing aspirate. PEROUSE MEDICAL is the Cardio- the calcium disrupting power of everlinQ endoAVF System has received The system has CE Mark for peripheral Vascular and Adult Long term lithotripsy with the familiarity and CE Mark and is not available for sale in vascular indications. Vascular Access specialist within simplicity of a balloon in a single the United States. VYGON group. The Vascular Access enabling device. www.TVAMedical.com Ziehm Imaging Division offers a full spectrum of shockwavemedical.com Booth 309 central venous catheters for infusion Vascular Insights Ziehm Imaging has stood for the therapies. PEROUSE MEDICAL Spectranetics Booth 508 development, manufacturing and Cardiovascular Division develops a Booth 308 Vascular Insights, LLC engages in the worldwide marketing of mobile full range of technically sophisticated The company’s products are sold in over design, development, manufacturing X-ray-based imaging solutions for cardiovascular implants for both 65 countries and are used to treat arterial and marketing of medical devices for more than 40 years. The company is surgical and endovascular procedures. disease in the heart and legs and in the the minimally invasive treatment of the recognized innovation leader in the www.perousemedical.com removal of pacemaker and defibril- peripheral vascular disease. mobile C-arm industry and has received lator leads. Spectranectis’ Vascular www.clarivein.eu several awards for its ground-breaking Philips Volcano Intervention products include Stellarex technologies and achievements. Booth 400 drug-coated balloon and AngioSculpt® Vascular News www.ziehm.com Philips is a technology company scoring balloon as well as a range of la- Booth 203 focused on improving people’s lives ser catheters for ablation of blockages in Vascular News is a trusted and editori- 3D Systems, Healthcare through meaningful innovation across arteries above and below the knee. The ally independent newspaper for vascular Booth 518 the health continuum, from healthy Company also markets support catheters and endovascular specialists. It provides 3D Systems healthcare solutions living and prevention to diagnosis, to facilitate crossing of peripheral and physicians with the latest news, com- enhance quality-of-life through the use treatment, and home care. It is a coronary arterial blockages, and retro- ment and analysis by thought-leaders, of 3Dprinting, surgical planning and unique perspective empowering us grade access and guidewire retrieval and industry news in the vascular and personalized medical technologies. all to create a healthier future. devices. endovascular world. Please visit booth ANGIO Mentor™ endovascular eu.volcanocorp.com www.spectranetics.com 400 for a free subscription. Follow us surgical simulators provide hands-on @VascularNews, or on www.facebook. practice for various interventions. RF Medical St Jude Medical com/VascularNews. PROcedure Rehearsal Studio™ assists Booth 405 Booth 306 www.vascularnews.com clinicians prepare for their upcoming RF Medical has 20 years of experi- St Jude Medical is a global medical intervention by creating a patient ence manufacturing Radio-Frequency technology leader, our breakthrough Veniti specific 3D model based on scanned technology. The VeinCLEAR catheter solutions guide healthcare providers in Booth 405 images. offers segmental ablation for the treat- their treatment decisions helping improve “VENITI is dedicated to advancing the www.3DSystems.com

18 Peripheral arterial disease March 2016 Edoxaban with aspirin may be a “paradigm shifting” treatment for peripheral artery disease patients treated with endovascular techniques Peripheral artery disease patients who undergo endovascular treatment may have a a regimen that targets all major components of lower risk of major and life-threatening bleeding events and a lower risk or restenosis the arterial thrombi may help preserve patency or occlusion when treated with edoxaban and aspirin, rather than with clopidogrel and restored by endovascular techniques in peripheral aspirin, according to a new proof of concept study. artery disease patients with a low risk of bleeding. In this trial, Moll and colleagues compared the rans Moll, University Medical Centre, Utrecht, combination of edoxaban (Lixiana/Savaysa, The Netherlands, presented the data on behalf Daiichi Sankyo) and aspirin with conventional Fof the ePAD (Edoxaban in peripheral arterial dual antiplatelet therapy treatment (clopidogrel disease) study steering committee and investigators. with aspirin) in maintaining post-femoropopliteal Research gains have improved operator endovascular therapy vessel patency in peripheral skill and device performance in peripheral artery disease patients. Moll noted that this “is the endovascular techniques. However, there has been first study to utilise a non-vitamin K antagonist limited research in medical therapy following oral anticoagulant in a dual antithrombotic peripheral endovascular procedures. According regimen in peripheral artery disease patients.” to Moll, guideline recommendations still vary The 200 enrolled US and European patients significantly, ranging from the use of aspirin alone all exhibited peripheral artery disease with to the use of clopidogrel with aspirin for one to Rutherford class 2–5 and had undergone successful three months followed by continued long-term endovascular treatment (≤30% residual stenosis) aspirin use. Treatment recommendations focus in the superficial femoral artery and for proximal on platelet aggregation, and exclude the role of popliteal lesions. They were randomised 1:1 to the the coagulation cascade in thrombus formation. two groups and follow-up visits were scheduled Loss of patency after endovascular treatment for one, two, three, four and six months. Patients remains high, ranging from 17–>40% with dual with active bleeding or high bleeding risk or with antiplatelet therapy. Endovascular treatment creatine clearance <30mL/minute were excluded, can also result in catheter-induced damage as were patients with ongoing indications for dual to the endothelium, exposing tissue factor- antiplatelet therapy or anticoagulant treatment. rich subendothelium to the blood stream and Patient characteristics were similar at baseline. creating a thrombogenic environment wherein Around 70% of patients in both groups had platelets and coagulation factors are activated. Rutherford classification of 3 or higher, indicating Moll told delegates that the development of Frans Moll severe claudication. Lesion length was ≥7cm in March 2016 Carotid stenting 19 roughly 60% of patients in both groups, stenosis was observed in approximately Increased age and left-sided procedural 64% of both groups and occlusion in approximately 35% of both groups— “serious pathology,” Moll said. approach increase the risk for stroke, The study’s primary safety endpoint was focused on adjudicated bleeding myocardial infarction or death within 30 days using TIMI and ISTH criteria, and primary efficacy endpoint was of carotid artery stenting restenosis or reocclusion at six months, defined as peak systolic velocity ratio election of patients for carotid uring >50%. Factors influencing the was deployed, use of an open-cell ≥2.4 at the treated segment obtained artery stenting should take risk of stroke, myocardial infarction, stent conferred higher risk than use using duplex ultrasonography. Sinto account risk factors for or death within 30 days of carotid of a closed-cell stent (RR 1.92, 95%; Edoxaban with aspirin showed lower periprocedural stroke including artery stenting were examined in a CI 1.11–3.33). Cerebral protection incidence of major bleeding (0) and any symptoms, the patient’s age and side regression model for the 828 patients device use did not modify the risks of bleeding (5) compared with clopidogrel of the procedure. Stenting should be randomised to carotid artery stenting carotid artery stenting. (major bleeding=2, any bleeding=9) used with caution in older patients, in whom the procedure was initiated. “Selection of patients for carotid ar- as measured by TIMI criteria. ISTH according to a new study published Of the patients, 7.4% suffered tery stenting should take into account criteria non-major bleeding (11 vs. in the European Journal of Vascular stroke, myocardial infarction, or risk factors for periprocedural stroke 8) and any bleeding (30 vs. 28) were and Endovascular Surgery. death within 30 days of carotid artery including symptoms, the patient’s higher with edoxaban and aspirin The authors—led by David Doig, stenting. Age was identified as an age and side of the procedure,” the than clopidogrel and aspirin, though University College London, UK, on independent predictor of risk (risk authors suggest. “Stenting should be major bleeding was lower (1 vs. 5). behalf of the International Carotid ratio [RR] 1.17 per five years of used with caution in older patients. Six-month composite endpoint Stenting Study (ICSS)—were aiming age, 95%; confidence interval [CI] These results favour the use of event rates showed that edoxaban to determine whether there were spe- 1.01–1.37) in carotid artery stenting. closed-cell stent design, without the was a more favourable treatment than cific factors related to carotid artery Risk was found to be “significantly addition of a cerebral protection de- clopidogrel in all events of restenosis/ stenting procedures, the process of lower” in patients undergoing a right- vice, and reinforce the need for dual reocclusion, with or without target care, or baseline patient characteris- sided procedure (RR 0.54, 95%; CI antiplatelet therapy with aspirin and lesion revascularisation, amputation tics that significantly increased or de- 0.32–0.91), when aspirin and clopi- clopidogrel.” They continue, writing and/or major adverse cardiac events. creased the risk of stroke, myocardial dogrel were used in combination prior that “Increased power to further char- It was also the more favourable infarction, or death within 30 days of to carotid artery stenting (compared acterise groups of patients at higher treatment for all different patient carotid artery stenting in the ICSS. with any other antiplatelet regimen, risk or technical procedures associ- characteristics including gender, The ICSS is a large, randomised, RR 0.59, 95%; CI 0.36–0.98) and in ated with an increased complication lesion length, age and region. controlled, open clinical trial compar- those presenting only with amauro- rate will be facilitated through com- Following these encouraging ing the safety and efficacy of carotid sis fugax. Smoking status and the bined individual patient data analyses results, Moll told the audience that “an artery stenting and carotid endar- severity of index event were also from recent randomised trials of adequately sized trial will be needed terectomy in patients with recently found to be independent predictors carotid stenosis as part of the Carotid to confirm this potentially paradigm symptomatic carotid stenosis meas- of risk. For patients in whom a stent Stenosis Trialists Collaboration.” shifting treatment approach”. 20 Embolic protection devices March 2016 Embolic protection devices may be key to reducing cerebral injury during thoracic aortic stent grafting

injury is yet to be determined. We have conducted a pilot study to investigate GAGANDEEP the feasibility and safety of a CEPD in patients undergoing TEVAR. In a pulsatile flow model of a thoracic GROVER aortic aneurysm, the Sentinel Cerebral Protection System was tested with each COMMENT & ANALYSIS of the commercially available thoracic aortic stent grafts (from Bolton Medical, Cook, Gore and Medtronic) to assess Although thoracic endovascular aortic repair (TEVAR) is physical compatibility. The System was associated with reduced overall morbidity and mortality as successfully deployed and retrieved in all compared to open surgical repair for thoracic aortic disease, pulsatile flow model cases (n=8). stroke remains a significant risk for patients, with reported We performed the first UK in-man case rates of up to 10%. Cerebral embolisation during aortic arch of CEPD during TEVAR at the Imperial instrumentation has been identified as a primary risk factor for Vascular Unit, St Mary’s Hospital, London, perioperative stroke during TEVAR, writes Gagandeep Grover. in November 2015. To date, four patients with suitable aortic arch anatomy have esearch from our group investi- during stent graft deployment and contrast undergone TEVAR with CEPD, together Figure 3: Sentinel Cerebral Protection gating over 50 patients undergo- injections (Figure 2). Neurocognitive with intra-operative transcranial Doppler System. Embolic protection filters Ring TEVAR has demonstrated testing in patients with silent cerebral monitoring of the middle cerebral arteries deployed at origin of innominate and left a 68% “silent” cerebral infraction rate. infarction demonstrated a neurocognitive and pre- and postoperative (days two to common carotid Silent cerebral infarction is brain injury deficit in six out of seven domains five) 3 Tesla diffusion-weighted MRI to detected on diffusion weighted magnetic assessed; this deficit persisted in the early identify new silent cerebral infarction resonance imaging (MRI) in with the postoperative period and was shown to lesions. Alongside a clinical neurological absence of clinically detectable focal affect not only those patients >75 years examination, patients have completed neurological abnormality (Figure 1). but also a younger cohort. preoperative, postoperative and six- week neurocognitive testing using a Silent cerebral infarction – Cerebral embolic protection validated battery to detect any sub-clinical not so silent devices and experience neurological deficit in the domains of Silent infarction has been demonstrated to with TAVI visual memory, executive function, manual be a predictor of future stroke, increasing Cerebral embolic protection devices dexterity, attention and decision making. the risk two- to four-fold. There is also (CEPD) are currently used as adjuncts In the four patients (two female, evidence to link it with increased risk in other endovascular procedures, two male; median age 69) who have of consequent dementia, depression such as transcatheter aortic valve undergone TEVAR with CEPD, the and neurocognitive decline. In a study insertion (TAVI) and carotid artery indication for stent grafting was acute Figure 4: First UK in-man CEPD in of 52 patients undergoing TEVAR for stenting to reduce the risk of cerebral aortic syndrome. Proximal landing zones TEVAR. Proximal and distal filters in situ a range of thoracic aortic pathologies, injury. The Sentinel Claret Protection were 2 (n=2) or 3 (n=2). Atheroma brachiocephalic and left common carotid. we demonstrated an 81% total cerebral System (Claret Medical) is an embolic grade of the aortic arch, as assessed on TEVAR distal left subclavian infarction rate, including 13% overt capture device, involving dual filters preoperative computed tomography stroke and 68% silent cerebral ischaemia. deployed, via percutaneous access aortogram, was 1 (n=2) or 2 (n=2). SCPS Transcranial Doppler monitoring of the (6F radial or brachial), at the origin of was successfully deployed and retrieved middle cerebral arteries during TEVAR the brachiocephalic and left common in all cases. As an adjunctive procedure, demonstrated that cerebral embolisation, carotid arteries. The filters have 140µm use of SCPS did not significantly increase or “high intensity transient signals”, pores and are retrievable, allowing for procedure time, radiation exposure or was detectable in all procedures, with histopathological analysis of captured contrast usage. maximum showers of emboli occurring embolic debris (Figure 3). Maximum high intensity transient Figure 5: Histopathology of a retrieved The use of CEPD with TAVI has shown signals were detected during the stent proximal filter encouraging results. Recent randomised graft manipulation and deployment Conclusion controlled trials have shown a significant phases and during contrast runs. In this pilot study, CEPD deployment during decrease in number and volume of Cerebral embolisation was also TEVAR resulted in low volume silent new silent cerebral infarction lesions, measured during CEPD manipulation, cerebral infarction lesions in two out of four associated with improved neurological deployment and retrieval. We have patients with no neurocognitive decline post- outcomes. The MISTRAL–C trial from also used dual frequency transcranial operatively, out to at least six weeks. The Netherlands and CLEAN-TAVI Doppler ultrasound software to allow This is the first study to report use of trial from Germany have both shown a differentiation of the emboli into gas CEPD with thoracic aortic stent grafts. reduction in brain lesions and neurological and solid. SCPS appears feasible and safe to use in Figure 1: Silent cerebral infarction. Post- events, demonstrated that removing No patient undergoing TEVAR patients undergoing TEVAR. Although the operative MRI patient with TEVAR and no embolic debris from the cerebral with SCPS developed stroke. Two of preliminary results appear encouraging, clinical stroke circulation can significantly shield and the four patients had no new lesions further work is now required to investigate protect the brain. Embolic on postoperative diffusion-weighted whether CEPD can reduce risk of cerebral debris has been captured MRI and the remaining two patients injury in this patient cohort. in approximately 75% of demonstrated new small volume lesions all cases of TAVI where a only. None of the four patients showed Gagandeep Grover is a vascular specialist CEPD has been deployed. evidence of neurocognitive decline in the registrar and clinical research fellow at postoperative period. Imperial College, London. This project Cerebral embolic All filters were sent for histopathological was headed by Richard Gibbs, consultant protection in analysis. Every filter had captured debris; vascular surgeon and clinical lead vascular TEVAR the principle components seen were surgery. Collaborators include Nung The use of CEPD during arterial wall and organising thrombus, Rudarakanchana, specialist senior vascular Figure 2: High intensity transient signals. Shower of TEVAR and its potential although in some cases foreign material registrar; Anisha Perera, specialist emboli through middle cerebral arteries on transcranial impact on cerebral and aortic valve tissue were recorded vascular registrar; and Mohamad Hamady, Doppler monitoring during thoracic stent graft deployment embolic rates and brain (Figure 5). consultant interventional radiologist

22 Lower limb March 2016 Patterns of symptomatic restenosis: less reintervention and reduced plaque burden with drug-eluting stent Studies have indicated that patterns of restenosis affect long-term outcomes following retreatment in the superficial femoral artery. Gary Ansel, OhioHealth/Riverside Methodist Hospital, Columbus, USA, presented results at the Leipzig Interventional Course (LINC; 26–29 January 2016, Leipzig, Germany) showing that, when in-stent restenosis occurs, it is more often focal with a drug-eluting stent (Zilver PTX, Cook Medical), whereas it is more diffuse with bare metal stents. The drug-eluting device, according to Ansel, yields less restenosis, less reintervention and reduced plaque burden.

rug-eluting stents (Zilver PTX), eluting balloons have shown that “lesion In the study, 133 patients with in-stent Ansel said, are the only cur- length affects patency outcomes”. restenosis were analysed: 29% had class Drent option for endovascular Tosaka et al (J Am Coll Cardiol I in-stent restenosis (focal, ≤50mm); Gary Ansel intervention in the superficial femoral 2012;59:16–23) have demonstrated that 38% had class II (diffuse, ≥50mm); and artery that provides stable patency, patterns of restenosis after treatment 33% class III (totally occluded). At two and 84.8%, respectively. The study also “proven by five-year data”, and added with bare metal stents are predictors years, restenosis rates after treatment showed that more diffuse than focal that previous studies of stents and drug- of in-stent restenosis and occlusion. with angioplasty were 49.9%, 53.3%, lesions occluded after reintervention. The same patterns were seen by Armstrong et al (Cath Card Interv 2013;82:1168–74) in a study analysing reintervention with adjunctive therapies (atherectomy and/or stenting). Ansel also noted that the VIBRANT study (Viabahn) has suggested that focal restenosis may lead to fewer clinical issues and may allow up to 50% higher flow rate compared to diffuse restenosis. He went on to question whether restenosis patterns impact the need for reintervention, and added, “Data from the randomised ZILVER PTX trial showed that the 12-month restenosis rate was 9.7% with Zilver PTX and 25.3% with Zilver bare metal stent, and target lesion revascularisation was 5.3% with the drug-eluting device vs. 17.2% with the bare metal stent. The percentages of restenoses requiring intervention were 54.6% with Zilver PTX vs. 70% with the bare metal stent. There was significant reduction in restenosis and target lesion revascularisation with Zilver PTX and, for patients with restenosis, Zilver PTX further reduces the need for treatment.” To further investigate patterns of restenosis and drug elution, an analysis of studies with Zilver PTX (ZILVER PTX randomised study, FLEX EU study and Japan PMS study) was conducted. It identified 14 in-stent restenoses treated with the Zilver bare metal stent and 19 with Zilver PTX. The Zilver PTX group had more patients with Rutherford class 3 (63.2% vs. 28.6%) and longer lesions (15.7cm vs. 12.2cm), whereas the bare metal stent group had a larger number of occlusions (64.3% vs. 50%). When looking at the types of restenosis, Ansel noted that in-stent restenosis patients treated with the bare metal stent presented with diffuse restenosis, whilst those treated with Zilver PTX had more focal lesions. Additionally, plaque burden area was lower with Zilver PTX (17%) vs. bare metal stent (28%)—a 39% relative reduction (p=0.03). Ansel concluded by saying that Zilver PTX reduces the rate of restenosis by 41% in relation to the Zilver bare metal stent. It also reduces the rate of reintervention by 47% and plaque burden by 39% when compared to the bare metal stent. In terms of treatment, he noted that focal restenoses are easier, faster and cheaper to retreat than diffuse restenosis.

24 Bioresorbable stents March 2016 Absorb bioresorbable stent achieves 95.5% primary patency at 12 months A 12-month update on a study investigating the use of the Absorb markers to ensure accurate placement. of more than one year and de novo drug-eluting scaffold (Abbott) in below-the-knee arteries (ABSORB “Rather than leaving behind a metal lesions of >60%. The team only wanted BTK) indicates that bioresorbable vascular stents can achieve good implant which makes the vessel rigid,” to use two scaffolds in any one lesion, so immediate angiographic results and promising 12-month patency. Varcoe said, “we are trying to restore the lesion length was capped at 5cm, and the function of that vessel, and by doing so diameter range was 2.5–4mm. Treated he update was presented by Ramon stenting or plain balloon angioplasty.” reduce late occlusive events.” Thus far, inflow lesions were accepted and the trial Varcoe, Sydney, Australia at the However, “these devices are far from Varcoe said that the research team have focused on the tibial arteries (although T2016 Leipzig Interventional Course perfect”. Issues include late thrombosis observed plaque regression and luminal it did include the distal popliteal). (LINC; 26–29 January, Leipzig, Germany). rates, fixed and rigid blood vessels post- gain as the stent structure dissolves. The “It quickly became apparent that this Metal drug-eluting stents can achieve deployment, artefacts on imaging and that structure itself is “mostly taken away in the was a safe device and easy to deploy in good results, Varcoe told the audience. they are impediments to future interventions. 12–18-month window and is completely this part of the body, so we then focused “I have been using them for a long time Absorb is a bioresorbable everolimus- invisible by three years,” he noted. our attention on clinical endpoints,” because they work,” he said, “and three eluting scaffold with a multilink design The single-centre study enrolled patients Varcoe said. Clinical improvement was previous randomised controlled trials have and circumferential hoops. The scaffold with chronic lower limb ischaemia with measured by primary, assisted primary shown that drug-eluting stents are clearly (150µm strut thickness) has straight Rutherford classification 3–6. These and secondary patency rates, as well as superior to standard therapy of bare metal connection bridges and radiopaque platinum patients needed to have a life expectancy target lesion revascularisation and total vascular regeneration (measured using duplex ultrasound follow-up at one, three, six and 12 months, with a peak systolic velocity ratio of >2). The team also looked at improvements in patients’ Rutherford-Becker Class classifications. Thirty-seven limbs (in 32 patients, age range 65–97 years) have so far been treated with 48 scaffolds, 73% of which exhibited critical limb ischaemia and 27% intermittent claudication. Mean lesion length was relatively short at 18.7±11.1mm. There was a range of vessels treated across all of the below- the-knee arteries, although most were in the proximal third of the tibial arteries, particularly the tibial-peroneal trunk, “whose length and diameter really does suit this device,” Varcoe said. Varcoe reported 100% procedural success with one acute occlusion (day one, no dual antiplatelet therapy, which was “an oversight” on the part of the investigators). Four deaths occurred outside of 30 days and were unrelated to the device. Sustained clinical improvement (Rutherford-Becker category) was seen in 73% of patients. Primary patency and assisted primary/secondary patency were 95.5% and 100%, respectively. The study team achieved 100% salvage, while target lesion revascularisation and total vascular regeneration rates were both 4.5%. Varcoe compared the results with existing randomised control trials evaluating infrapopliteal lesions treated with plain balloon angioplasty, bare metal stents, drug-eluting stents or drug-coated balloons. He told the audience that the standard therapy arms—plain balloon angioplasty and bare metal stenting—of the trials cluster around primary patency rates of approximately 50–60% and drug-eluting stent results cluster slightly higher at approximately 80% primary patency. The ABSORB BTK results sit above these at 95.5% primary patency. “Vascular restorative therapy with a bioresorbable scaffold offers several advantages over metal drug-eluting stents,” Varcoe concluded. “Bioresorbable scaffolds can be implanted safely within the tibial vasculature, and excellent immediate angiographic results and promising 12-month patency can be achieved.” “I think that the idea of leaving nothing behind is a great concept and one that we all believe in at this point in time, but most of us know that there is a need for stent-like scaffolding in many of our patients,” Varcoe suggested.

March 2016 Updates 27 IRAD data suggest that expanding use of TEVAR reduces long-term aorta-related complications for type B dissection University of Michigan Health System With 2016 being the 20th anniversary of the set-up to update the International Registry of Acute Aortic Dissections way in which IRAD (IRAD), Kim Eagle, Walter Hewlett Professor of utilises imaging results. Internal Medicine and director of the Frankel How has the use of Cardiovascular Center at the University of Michigan more modern imaging Health System, Ann Arbor, USA, and senior algorithms informed the investigator of IRAD talks to Vascular News about evaluation of the IRAD the key findings from the registry. data? We believe that imaging has the IRAD was established known aortic aneurysm, inherited potential to provide much more in 1996, and currently disorders like Marfan syndrome prognostic information than has 43 large referral or bicuspid aortic valve disease, we have garnered in the past, centres in 13 countries repeated cocaine exposure, and and the methods which more participating in the possibly pregnancy in at-risk clearly define fluid dynamics, registry. What do you young women. aortic wall biology, and subtle think are the most changes in size and morphology important data to In the light of current measured over time will allow a have emerged from data, are the terms more personalised approach to the registry so far? “acute” and “chronic” treatment and follow-up. This The registry has provided so with regard to is the promise of new imaging much information that has illumi- dissection still relevant? techniques and protocols. IRAD nated the field. As a database of Is there a proposal for seeks to capture this increased over 6,000 patients, it has provid- a different temporal granularity of information in ed the most reliable information classification to guide updated case-report forms. on how acute management? presents, how it is currently man- Our new IRAD classification Today, what are the aged and how patients do both in system places patients into four main questions that the short and long term. A new groups based on time to pres- you still have in your classification system according to entation: “hyperacute” patients, research into acute time of onset of symptoms until present within the first 24 hours aortic dissections? the patient has been seen was and have a mortality of 18% for There are so many! As examples: published just last year. IRAD type A dissection without surgery; Kim Eagle Will endovascular treatment allow has also allowed us to see the “acute” patients present from day non-open surgery for a propor- influence of advances in treat- two through seven and have an pending rupture; malperfusion of IRAD data are consistent with a tion of type A dissections? Will ment on outcomes. Over twenty additional mortality of 20% for an extremity or vital organ; unre- potential late benefit (after 1–2 TEVAR become the standard of years of study, the mortality of this period if not operated; “suba- mitting pain or hypertension; and years) in reducing aorta-related care for type B dissection? How type A dissection has improved cute” patients present from day imaging evidence of progressive complications as a result of stent will we develop more personalised as surgeons around the world eight to 30 and have an additional aortic expansion in spite of good graft therapy. While I believe follow-up plans for an individual? have been willing to operate on mortality of 10%; and chronic medical treatment or dissection that we need a large randomised Will genetics and proteomics allow increasingly complex patients. patients present after day 30 and extension. trial to definitively answer this better prevention, diagnosis and Similarly, IRAD suggests that for we see that mortality flattens out. question, data so far are suggest- treatment for dissection? How will type B dissection, the expand- There has been some ing that TEVAR promotes aortic we find “at-risk” patients in the ing use of thoracic endografts is Management of type suggestion of the remodelling which reduces the future? What medical treatment reducing long-term aorta related B acute dissection benefit of TEVAR when size and risk of rupture of the will be optimal for the prevention complications. has remained compared to optimal false lumen and promotes a larger of post dissection complications? challenging. In your medical therapy alone and healthier true lumen. With our interventional working What are the risk view, what constitutes for uncomplicated type group, we hope to delineate opti- factors for acute aortic a complicated type B B dissection patients. There were new mal methods of cannulation, brain dissections? dissection? What is your view on IRAD working groups and spinal cord protection, optimal The typical risk factors are old Complicated type B can be the place of TEVAR launched in 2010. One endovascular stent strategies, the age, hypertension, a history of defined in several domains but in managing these of these is a dynamic role for hybrid approaches, and prior heart or aortic surgery, would include: rupture or im- patients? imaging working group many other critical questions. Eluvia drug-eluting stent receives the CE mark oston Scientific has release, CE mark approval was JESTIC trial, which included news to physi- received CE mark for based on data from the MA- a high percentage of patients cians and Bthe Eluvia drug-eluting JESTIC trial, a prospective, with complex lesions, demon- patients who vascular stent. It is to begin multicentre clinical trial that strate that this technology is a have not Eluvia commercialisation of the prod- assessed the safety and per- safe and efficacious solution previ- uct immediately in countries formance of the Eluvia stent for patients needing stents for ously had which recognise CE mark. system and reflected a primary the treatment of peripheral access to a The Eluvia stent system— patency rate of more than artery disease,” says Stefan polymer based, which is designed to restore 96%. The MAJESTIC trial Müller-Hülsbeck, principal drug-eluting blood flow in the superfi- results represented the highest investigator at the Vascular stent, specifically ef- cial femoral and proximal 12-month primary patency Center, Diako Flensburg, and developed for the su- ficacy of the popliteal arteries—features reported for an interventional head of the Department of perficial femoral and proximal Eluvia stent system a drug-polymer combina- treatment of femoropopliteal Diagnostic and Interventional popliteal arteries.” compared with the Zilver PTX tion intended to allow for the artery lesions among compara- Radiology/Neuroradiology, Boston Scientific received an Stent (Cook Medical). Enrol- sustained release of pacli- ble trials, according to Boston Academic Hospitals Flensburg, Investigational Device Exemp- ment began in the fourth quarter taxel. This drug can prevent Scientific. Germany. “The approval is a tion to conduct the global, of 2015, and the study should restenosis of the vessel. “The exceptional 12-month testament to the strength of prospective IMPERIAL trial, include approximately 485 pa- According to a company results presented in the MA- the data, and will be welcome which will assess the safety and tients in 75 sites worldwide. 28 Drug-eluting stents below the knee March 2016 Evidence in below-the-knee angioplasty: Drug-coated balloons or drug-eluting stents?

any improvement in restenosis rates and, on angioplasty; and one third are longer than the contrary, raised some concerns regarding 200mm, out of the range of every published their safety. It is disappointing to observe study. Moreover, if we analyse the site ROBERTO how, in the uncoated balloon arms, where of the treated lesion, the majority of the operators applied the oldest and best known studies on below-the-knee stenting have FERRARESI technique, the restenosis rate was very considered only the proximal and mid part different in the monocentric in comparison of the vessels, demonstrating that stenting in with the multicentric studies, suggesting the distal below-the-knee and foot vessels COMMENT & ANALYSIS different settings of patients, types of treated leads to very high rates of stent compression, lesions or techniques of dilatation. The fracture and failure. Below-the-knee vessel disease is one of the new frontiers in lack of standardisation in methodology and In conclusion, drug-eluting stents have endovascular treatment. In diabetic patients presenting with endpoint definitions makes comparison of demonstrated their superiority to plain critical limb ischaemia, below-the-knee vessel disease is wide- these studies quite complex, and reliable balloon angioplasty and bare metal stenting spread, and the modern targets of endovascular treatment—the conclusions difficult to draw. Further studies in a small subset of focal below-the-knee wound related artery or complete revascularisation—are beyond directly comparing the two methods are lesions confined in the proximal and mid the ankle. Treatment of below-the-knee vessels is considered a necessary to further clarify this issue. part of the calf. In this specific setting, standard therapy to achieve high level of limb salvage and wound Stent implantation has been advocated drug-eluting stents should be considered the healing. However, as Roberto Ferraresi writes, despite general for the treatment of infrapopliteal arteries. standard of care. agreement on the clinical efficacy of angioplasty below the knee, Vessel scaffolding eliminates acute vessel Long lesions, distal below-the-knee and questions regarding the best technical approach remain. recoil and dissection and provides better below-the-ankle vessels are actually out angiographic results than plain balloon of the domain of stents. In this extreme ignificant clinical experience with recurrence of critical limb ischaemia and angioplasty. Moreover, the use of drug- periphery of the vascular tree, plain plain old balloon angioplasty using repeat revascularisation. Thus, in order eluting stents seems to offer even better balloon angioplasty still represents the Suncoated balloons in below-the-knee to increase the patency rate of the treated results than bare metal stents in terms of only reasonable treatment. The conflicting lesions has been collected, and this can vessel, some different strategies have been increased vessel patency, freedom from data on drug-coated balloons could be be considered the standard technique for introduced, such as the application of drug- target lesion revascularisation and decreased explained with the lack of a standardisation endovascular treatment. However, there coated balloons, bare metal stents and drug amputation rate. of below-the-knee plain balloon angioplasty. are basic limitations of this approach, such eluting stents. In comparing current literature regarding In coronary artery angioplasty in the last as high rates of early recoil, dissection and The rationale for the use of drug-coated below-the-knee vessel treatment and real 40 years, we have analysed every detail restenosis, which are unacceptable in other balloons is the delivery of a drug at the level world clinical practice, some critical aspects of plain balloon angioplasty and stenting, anatomical settings such as the coronary, of the treated vessel segment in order to must be underlined. One of the most evident achieving a mature technique exported carotid or iliac arteries. In the attempt to prevent or moderate the cellular response is the discrepancy in the length of treated worldwide. On the other hand, too many justify these contradictory data (good clini- leading to restenosis. The use of such lesions, which evidently reflects a bias in basic questions remain open with below-the- cal outcomes versus poor acute results and balloons in below-the-knee vessels has been patient selection. The vast majority of the knee angioplasty: What should be the proper restenosis rates), it has been suggested that, investigated by few studies, with conflicting studies of below-the-knee stenting consider balloon inflation time? High pressure or low in critical limb ischaemia patients, vessel results. Schmidt and Liistro, in their a <50mm lesion length, while studies on pressure? What is the correct balloon-to- patency is not so important; a temporary monocentric studies, found an outstanding plain balloon angioplasty (uncoated or vessel ratio? Cylindrical or conical balloon? haemodynamic improvement might be reduction of the restenosis rate from about drug-coated balloons) consider a lesion Before running ahead with new enough to achieve wound healing in the ma- 70% with uncoated balloons to less than length of 50–200mm. In the real world devices, we should learn when and how jority of patients, and repeat procedures are 30% with drug-coated balloons at three and of a referral diabetic foot clinic, only one to use the oldest one—uncoated balloon considered an acceptable part of the ordinary 12 months respectively. These data were third of below-the-knee lesions are ≤50mm angioplasty—below the knee. treatment. Despite this realistic approach, a not confirmed by the multicentric IN.PACT long in the domain of bare metal stents and durable patency of a below-the-knee vessel DEEP and BIOLUX P-II trials, in which drug-eluting stents; one third are 50–200mm Roberto Ferraresi is an interventional would be desirable in order to reduce the drug-coated balloons failed to demonstrate long in the typical domain of plain balloon cardiologist in Bergamo, Italy Drug-eluting rather than bare metal stents are best for below-the-knee lesions

Drug-eluting stents as opposed to bare metal stents should be used in below-the-knee The primary endpoint was primary patency at six and lesions, if stenting is unavoidable, suggest one-year results of the PES-BTK-70 study, 12 months, defined as the absence of restenosis (≥50% which is investigating the below-the-knee arterial use of self-expanding paclitaxel- stenosis) or occlusion within the originally treated lesion coated stents. based on and verified by core lab. Peeters reported a 72.6% 12-month primary patency, atrick Peeters, Imelda Hospital, Bonheiden, balloon angioplasty and bare metal stenting, balloon a 79.1% 12-month rate of freedom from target lesion Belgium, also told delegates at the 2016 Leipzig angioplasty should be used as it is an easier procedure revascularisation and a limb salvage rate of 98.5%. At PInterventional Course (LINC; 26–29 January, and is less expensive. However, he said, “These results baseline, 33 patients were in Rutherford class 5, but by Leipzig, Germany), that they should “try to avoid stent- are not significant and the patient cohort was too small”. 12 months this number had fallen to 11. Thirty-seven ing with bare metal stents in below-the-knee lesions”. In the PES-BTK-70 study, Peeters and colleagues patients were in class 4 at baseline, while 2 remained at 4 Peeters told the audience about three previous studies examined the use of self-expanding paclitaxel-eluting at 12 months. There were no patients in class 0 at baseline looking at drug-eluting stents in below-the-knee lesions: stents, using the Stentys stent system (Stentys). The compared with 35 at 12 months. “All patients are now in a the sirolimus-eluting Yukon stent (Translumina) versus prospective, non-randomised, multicentre study is lower Rutherford class than at baseline,” Peeters noted. bare metal stenting; the everolimus-eluting Xience stent evaluating the immediate- and long-term (12 months) No stent fractures were reported. Peeters suggested that (DESTINY trial, Abbott) versus bare metal stenting; and outcome of the stent in <50mm lesions. The study enrolled surgeons “Avoid balloon-expandable stents due to risks of the sirolimus-eluting Cypher stent (ACHILLES study, 70 patients (45 male, average age 74.64 years) with crushing and stent fractures”. Cordis) versus plain balloon angioplasty. The three trials Rutherford classification 4 (37) and 5 (33) with de novo The one-year patency rates (72.6%) were comparable reported an overall improvement of ±20% in patency or restenotic lesions after plain balloon angioplasty in the to the three previously-mentioned trials (all ranging rate at one year after treatment with a sirolimus-eluting infrapopliteal arteries and a total target lesion length of from 75–82.5%), as was device performance when stent when compared with a bare metal stent or plain ≤50mm. The patient cohort characteristics were “what you measuring limb salvage rates, freedom from target balloon angioplasty. Peeters said that the results indicated would expect” for a below-the-knee study. Lesion length lesion revascularisation and primary patency, Peeters that, as there is no difference in outcomes between plain was 19.7mm on average and procedure success was 97%. told the audience.

30 Profiles March 2016 A year in profiles In the past year, Vascular News has published the profile of a four though- leaders in the vascular and endovascular field. Here, some of their most interesting experiences and important work have been highlighted.

Janet Powell anet Powell, Imperial an endovascular strategy, even College, London, UK, spoke though there was no significant Jto Vascular News about her survival advantage. In addition, the career so far in June 2015. One endovascular strategy appeared to of her major research interests be cost-effective.” is the cause and management of The trial also showed the abdominal aortic aneurysms, an influence of aortic neck length interest that “began through my in predicting mortality, Powell interest in the pathophysiology explained: “The easy EVAR cases of elastic tissues,” Powell said. with long proximal aneurysm “The first piece of work was a necks have low mortality after comparison of the concentration of both EVAR and open repair, acute phase reactants (including whilst those with short necks are CRP) in the serum of patients predominantly treated with open with abdominal aortic aneurysm repair and do much worse.” and patients with occlusive aortic “Overall,” she continued, atheromatous disease, pursuing “the current findings evidence for the hypothesis that from IMPROVE lead inflammation played an important to encouragement for role in the development of aortic the increasing use aneurysms. The death of my father of endovascular from aortic dissection sharpened repair. With survival my focus on degenerative of discharged disorders of the aorta.” patients being so Discussing the one-year results good at one year, of the IMPROVE trial (comparing with so few delayed endovascular aortic repair with reinterventions, we open repair for ruptured abdominal need the three-year aortic aneurysms), Powell results to confirm said that “the patient-preferred or refute such outcomes are all better using encouragement.”

Sebastian Debus ebastian Debus, Hamburg, within our University Heart Germany, was profiled Center, we were able to build a Sin Vascular News’ comprehensive aortic programme, September 2015 issue. which led to the opening of the “In my opinion,” he said, German Aortic Center Hamburg “the most important changes in 2012. New technologies were in vascular medicine over the introduced such as alternate years were the development transcardial access techniques of an independent surgical (transseptal and transapical), speciality, the introduction of as well as first experiences with endovascular and percutaneous antegrade stent graft deployment technologies, and the evolution “right through the heart”. We from pure vascular surgery were one of the first institutions towards a vascular specialist to introduce endovascular repair (non-operative surgery).” of the ascending aorta as well At his hospital— University as arch repair. Regular weekly Heart Center Hamburg- aortic rounds, with vascular Eppendorf—Debus works closely surgeons, heart surgeons and with colleagues from heart cardiologists are the cornerstone surgery to perform high-end for an interdisciplinary approach intervention in the ascending to extended aortic disease aorta and arch. Explaining the intervention. Due to a large rationale behind this approach, connective tissue disease he said, “By collaborating programme, new hybrid closely with our colleagues from approaches to these patients cardiology and heart surgery have been developed.” March 2016 Profiles 31

Bruce Perler n the final issue of 2015, last decade vascular surgery has Bruce Perler, Johns assumed a leading market share IHopkins University School in endovascular therapy. Now our of Medicine, Baltimore, USA, challenge is to make sure that our told Vascular News that the young trainees are adequately “endovascular revolution” has trained to do open surgery.” been one of the biggest leaps As for the future, Perler, in vascular surgery since he president of the SVS, began his medical career. said that “We have a way “I lived through the era when to go in developing the some of our respected leaders ideal devices that will felt that endovascular therapy satisfactorily configure was a passing fad and we to the curve of the should ignore it, and continue arch as a long-term to do our open procedures. solution to the treatment Thankfully, visionary leaders like of thoracic aortic or Frank Veith saw the light, felt thoracoabdominal aortic strongly that if we did not evolve disease. And, we will we would become extinct, and need to develop devices/ led the way. I remember the materials to compensate Society for Vascular Surgery for the confounding (SVS) leadership struggling to issue of the aorta as develop the mechanisms for a living structure that vascular surgeons to be trained may dilate or elongate in endovascular technique. I think over time. I do not see one of the great success stories chimney and periscope of our specialty, and of the SVS, grafts as a long-term is how quickly we developed solution to aneurysm those training paradigms and disease. The future will became not only endocompetent, clearly be fenestrated but evolved to where now and branched grafts. I vascular surgeons are some of think continued improvements the pre-eminent leaders in the in imaging technology will field. It is remarkable that over the parallel these advances.”

Jonathan Beard n the January 2016 Vascular vein is available. I have seen so News, Jonathan Beard, Northern many developments come and IGeneral Hospital, Sheffield, UK, go, including endothelial cell spoke about his career to date seeding, heparin bonding, and and current research interests. new biomaterials, but so far none He believes that some of the has fulfilled its initial promise.” most important developments in Beard’s special research the vascular field in recent years interests include supervised have been “the development of exercise programmes for patients statins, more effective antiplatelet with intermittent claudication. He and antihypertensive agents, and told Vascular News that despite more effective smoking cessation encouraging evidence that strategies. These have had a exercise programmes can help dramatic impact on the incidence with national targets for reducing of adverse vascular events. the levels of obesity and diabetes, Vascular surgeons need to be less than 20% of patients in the experts in vascular medicine UK and Europe have access to and risk-factor modification. It such a programme. He explained is a fact of life that many more that “The barriers include lack of patients with vascular disease promotion by vascular surgeons, benefit from tablets than the few most of whom prefer operating; who benefit from intervention.” lack of support from industry, Looking ahead, he said that who see no profit in it; and lack “The holy grail of vascular of enthusiasm from patients, technology is a non- who want a quick fix. We need thrombogenic small calibre graft a change of culture amongst or stent graft that can be used vascular surgeons to emphasise for infrainguinal bypass grafting the importance of physical or stenting, especially when no therapy and health advocacy.” 32 Vascular access March 2016 Vascular access in the elderly: “A venous access is always better” is key to both fistula placement and survival. In a study conducted in 11 Dutch centres (2007), primary failure occurred in one third of the cases. Primary failure rate among the participating centres varied from 8–50%. Compared with the two centres SELCUK BAKTIROGLU with the lowest primary failure rates, six centres had a significantly higher primary failure rate. This and other studies show that the probability of primary failure is strongly related to the centre COMMENT & ANALYSIS of access creation, suggesting an important role for the vascular surgeon’s skills and decisions. There are conflicting and controversial reports on vascular access use in the elderly. Earlier and more frequent nephrology visits were Although some authors report inferior outcomes of autogenous arteriovenous fistula found to be associated with improved first-year procedures in elderly patients, there is evidence that most of the problems encountered mortality on dialysis as well as increased use of fistulae. can be dealt with by a multidisciplinary team approach, early-timely nephrology referral Patients who were referred early and frequently to and decision-making, surgical skill and experience, believes Selcuk Baktiroglu. nephrologists were found to have significantly lower risk for death (adjusted hazards ratio 0.57; p<0.0001). ature, functioning arteriovenous fistulae planned management pathway, had a good nutritional A recent, very important paper came from David require far fewer interventions and lower status, and that those with an arteriovenous fistula Shemesh’s group in Israel (2015).They found Mcosts to maintain due to lower rates of as vascular access for haemodialysis at the time no significant difference in patency between the thrombotic and infectious complications and improved of initiation had a better survival. In numerous different types of accesses and between diabetic and patient survival compared to arteriovenous grafts. studies, including CHOICE, it was shown that nondiabetic patients older than 80 years. Secondary These benefits of fistulae over grafts make them the patients with usable fistulae have the lowest risk of patency was 92%, 83%, and 77% at one, two and preferred vascular access option for most patients. death.All-cause mortality and fatal infection risks three years, respectively. The group concluded that, However, some recent reports found that the rate are increased by approximately 1.2–1.4 times for contrary to recent recommendations favouring grafts of primary arteriovenous fistula failure and number grafts compared with arteriovenous fistulae. for haemodialysis in patients older than 80 years, of procedures required to achieve patency can be There are huge differences in practice patterns most elderly patients in their study were found to have quite high. Avoidance of primary fistula failure as a between continents, countries, regions, hospitals vasculature that was suitable for autogenous access result of early thrombosis or lack of maturation is the and practising surgeons. Studies have documented construction, with patency rates similar to those of key area for improving vascular access outcomes. considerable intercentre variability in vascular access their younger counterparts when adequate preoperative Nephrologists, surgeons and other staff members use and outcomes. This variability is attributed to planning and postoperative maintenance were carried should work together as a multidisciplinary team to variation in surgical skill and practices. While there out. Age alone should not disqualify patients older minimise the risk for primary failure while attempting are studies reporting up to 60% primary failure than 80 years from access surgery for haemodialysis. to increase the autogenous arteriovenous fistula rate. rates, there are centres and surgeons who perform In conclusion, choosing vascular access sites to Individuals ≥75 years of age constitute a considerable excellent practice on the same patient groups. be created in elderly patients should be no different percentage of patients with end-stage renal disease. The DOPPS (Dialysis outcomes and practice than for younger patients.This can be achieved with Regarding vascular access in this patient group, patterns) study (2008) showed that in Japan, a multidisciplinary team approach, early nephrology arteriovenous fistulae show superior results compared arteriovenous fistula use is well above 90% and in referral and decision-making, early referral for placement with grafts and central venous catheters with respect to Italy and Germany above 80%. In Canada and the of vascular access, restriction of vascular access both primary and secondary patency rates, as well as to USA, arteriovenous fistula use is around 50%. The procedures to experienced surgeons, routine preoperative infection and thrombosis. Current evidence suggests that median time from referral to evaluation and evaluation mapping (preferably by the practising surgeon), a the possible vascular access options and outcome in elderly to creation of vascular access also are very different dynamic and proactive close follow-up of maturation, end-stage renal disease patients are not different from by country. While it takes only five or six days in early-timely surgical and/or radiological intervention in younger individuals. Age should not be a limiting factor Italy, Japan and Germany, the creation of vascular case of non-maturation/complication, and with continuous when determining candidacy for arteriovenous fistula access takes 40–45 days in Canada and the UK. quality assessment. Autogenous arteriovenous fistulae creation due to equivalent survival and procedural rates. In another DOPPS study (2008) the risk of primary are the gold standard for all patients, no matter how old. It has been shown in numerous studies that older fistula failure was found to be 34% lower when patients (even including octogenarians) who received placed by surgeons who created >25 (vs. <25) fistulae Selcuk Baktiroglu is a vascular surgeon at Istanbul pre-haemodialysis nephrology care and followed a during training. It concluded that surgical training University Istanbul Medical School, Istanbul, Turkey Covered stents may be the answer to the question of failing arteriovenous access

Dheeraj Rajan, University of Toronto, Canada, posed the a bimonthly multidisciplinary meeting question to Leipzig Interventional Course (LINC; 26–29 January, with vascular surgeons, nephrologists, Leipzig, Germany) attendees as to how best to treat failing an interventional radiologist, a arteriovenous access, proposing that the solution involves dialysis nurse and an ultrasound vascular covered stents. technician. The focus of this meeting was preoperative planning n terms of dialysis access maintain dialysis access, he said. and postoperative surveillance. we have fistulae and grafts,” This choice comes down to a surgical In Group 1, prior to implementation “IRajan told the audience, way or an endovascular way. of the new protocol, treatment of “and we know that upper arm grafts The Optimized Care Protocol was 72 patients led to 63 postoperative do as well as fistulae.” Pointing to a Dutch retrospective, observational revisions (60 surgical, three a 2003 study, Rajan showed that review study published in 2008, radiological), 36% 12-month primary “after six months, maintenance which evaluated the influence of patency and 47% secondary patency. procedures are required to maintain a new protocol on the incidence In Group 2, with the optimised patency and accesses.” The question of revisions and patency rates in strategy involving a multidisciplinary “for a lot of people,” is how to patients. The protocol was formed of Dheeraj Rajan Continued on page 34

34 Vascular access March 2016 Covered stents may be the answer to the question of failing arteriovenous access

Continued from page 30 patient year to maintain patency, access circuit primary patency. different configurations; a straight endovascular approach; 74 patients compared with 2.9 procedures Bard extended the trial to a second configuration for use in anatomies underwent 48 postoperative revisions per patient year for upper arm study; the Renova study. This where the outflow vein diameter is (23 surgical, 25 radiological), and had fistulae and 3.3 procedures per followed patients out to 24 months in greater than or equal to inflow vein 12-month primary patency of 49% and patient year for prosthetic grafts. a 270-patient randomised prospective (or graft) diameter, and a flared secondary patency of 70% (p<0.001). As for the comparable efficacy of study. At 12 months there was almost configuration for use in anatomies From these data, the investigators bare mental stents, Rajan cited three a doubling of patency compared to where the outflow vein diameter found that with the optimised studies from the 1990s, which showed plain balloon angioplasty and, again, is greater than the inflow vein (or approach there were more effective that bare metal stents have “no better almost a doubling at 24 months. graft) diameter. Interestingly, in the logistics and a significant decrease patency than balloon angioplasty.” Another ongoing study that has previously-mentioned Flair pivotal in surgical revisions. Although Furthermore, Rajan noted that their just finished recruitment is the study, 84% of graft vein anastomoses there was a significant increase in use increases costs when compared Rescue study. “Keeping in mind needed the flared stent graft. endovascular balloon interventions, to plain balloon angioplasty, they that there is no device approved on There has also, Rajan said, been this also meant that there was lower add additional time to a procedure the market for in-stent restenosis a lack of modelling of motion in patient morbidity and that there and they also present a new problem; treatment, here they used the patients with dialysis access. A were higher primary and secondary in-stent restenosis (in addition Fluency device (Bard) with in-stent prospective US clinical study aimed post-intervention patencies. to the problem of stent fracture stenosis and they found that the to characterise the range of motion In terms of access location, Rajan present in older stent designs). patency rates were significantly that a permanent implant would be explained that forearm fistulae Rajan noted that Bard has better than compared to plain exposed to in the cephalic arch and “certainly” have the best intervention- conducted a number of studies balloon angioplasty,” said Rajan. axilla. Thirty patients were enrolled, free survival and the best primary specifically in dialysis accesses This past research has led to 15 with brachiocephalic fistulae patency after intervention. He looking at the use of covered stents the development of the Covera and 15 with brachiobasilic fistulae. continued, “Upper arm access— (the Flair endovascular stent graft, vascular covered stent (available Venograms were obtained when which are becoming much more Bard) to treat failing arteriovenous in the European Union), indicated the arm was adducted, adduced at common—actually has a much higher access. One of the best-known is for the treatment of stenoses 90 degrees and neutral. Based on intervention rate than access in the the 2010 randomised prospective in the upper extremity venous the range of motion measurements wrist. Prosthetic grafts are, naturally, study with angiographic follow- outflow of patients dialysing with from these patients, bending fatigue worse than fistulae all together.” up at six months. It found that an arteriovenous access graft or durability testing was developed A French study (2000) examined stent grafts achieved a doubling of fistula. The stent is flexible with a for evaluation with the Covera the efficacy of balloon angioplasty patency at six months compared to nitinol base and full encapsulation covered stent. Test samples were interventions in achieving secondary plain balloon angioplasty. There was with two ePTFE layers. The stent subjected to more than 10 million patency, discovering that forearm also almost a doubling of patency incorporates carbon impregnation cycles, and at final inspection, fistulae required 1.8 procedures per with the use of the covered stent for on its luminal surface. There are two no strut fracture was observed. March 2016 Mesenteric ischaemia 35 Life-threatening bowel ischaemia can often be treated by endovascular means Acute mesenteric ischaemia can be successfully treated with “These patients are elderly, fragile people mortality was 42%. The mean age of endovascular therapy such as balloon angioplasty, according to with numerous risk factors for operative the patients who received attempts at research from the University of Eastern Finland. mortality. The endovascular approach endovascular revascularisation was 79 years offers the possibility of avoiding surgery and their 30-day mortality was 32%. The he study also found that acute on CT, laboratory and clinical findings, in approximately half of acute mesenteric oldest survivor was a 94-year old lady who mesenteric ischaemia is a more all together. The diagnostic accuracy of ischaemia patients. During our five-year was treated with endovascular aspiration of Tcommon cause of abdominal pain CT alone should not be overestimated. study period, 3/4 of all patients with acute superior mesenteric artery embolus. Still, the among the elderly than generally thought, “We hope that this study will raise mesenteric ischaemia due to embolic or caveat accompanying the endovascular-first but also that it is difficult to diagnose before awareness among surgeons and atherosclerotic arterial obstruction from approach is not to postpone laparotomy if bowel damage develops. If left untreated, radiologists of the incidence of acute a well-defined population of 250,000 the symptoms do not resolve quickly after acute mesenteric ischaemia usually leads mesenteric ischaemia in older patients, inhabitants were treated with endovascular revascularisation. Failure to resect dead to gangrenous bowel, which is a life- as well as of the diagnostics-related therapy and only 1/3 of those patients bowel in time will lead to septic shock and threatening condition. Acute mesenteric challenges,” Kärkkäinen added. required bowel resection. The overall even larger bowel necrosis or death.” ischaemia usually results from an occlusion of the superior mesenteric artery, typically caused by arteriosclerosis or embolism. From 2009 to 2013, a total of 66 patients with acute mesenteric ischaemia were treated at Kuopio University Hospital in Finland. Mesenteric revascularisation by endovascular therapy was attempted in 50 of the patients, proving successful in 44. Three of the patients underwent a surgical bypass after failed endovascular therapy. The mortality rate among the 66 patients was 42%, which is a clear improvement compared to earlier treatment outcomes. Resection of gangrenous bowel was resorted to only in approximately one third of the patients, and more than half avoided surgery altogether. Acute mesenteric ischaemia has so far been regarded as a very rare condition. The study analysed the incidence of the disease within one hospital district in eastern Finland and found that in patients over 75 years of age, the condition is in fact a more common cause of acute abdominal pain than ruptured abdominal aortic aneurysm or acute appendicitis. The mean age of the treated patients was 79 years. Acute mesenteric ischaemia is usually diagnosed using contrast enhanced CT, which is generally regarded as a very reliable diagnostic method. However, the study demonstrated that it is difficult to make a definite diagnosis at the early stage of the disease. CT findings are often inconclusive, until after permanent bowel damage has developed. For the patient’s prognosis, however, it is crucial to make a diagnosis before bowel damage develops. Jussi Kärkkäinen, vascular surgeon and gastrointestinal surgeon, spoke to Vascular News about his recommendations for overcoming diagnostic challenges. “Many patients with acute mesenteric ischaemia, especially those with atherosclerotic aetiology, present with obscure symptoms such as vomiting and diarrhoea. The diagnosis can be incredibly difficult. Contrast-enhanced CT should be performed liberally to elderly patients with acute abdominal pain without fear of contrast-induced nephropathy if there is any suspicion of the condition. However, one-third of patients with acute or chronic mesenteric ischaemia in our study did not show any of the specific CT signs. Even so, nearly all patients had at least some abnormal intestinal findings (such as paralysis, mesenteric fat stranding, bowel wall thickening) in their CT examinations. The diagnosis is based 36 Lower limb March 2016

ADVERTORIAL Biomimetic Stents and the Benefits of Swirling Flow An overview of the haemodynamic and biomechanical advantages of a biomimetic stent designed for use in the SFA.

BY PROF. P.A. GAINES, MD

his article describes how a clear years after implantation of the LifeStent understanding of nature’s ability (Bard Peripheral Vascular), the target Tto maintain healthy patent arteries lesion revascularisation (TLR) rate was has led to the development of a new 22%, and after implantation of either generation of biomimetic stent that the Dynalink or Absolute stent (Abbott substantially improves clinical outcomes. Vascular), TLR was 63%. Patency and TLR rates are very important in terms Background of risks associated with reintervention 2A 2B Charles Thomas Stent was an English and costs. For the patient, there is a dentist who was appointed to the clear link between loss of patency and Figures 2A and 2B Gentle curvature of the SFA with the knee extended (A). With the Royal Household in 1855 after his recurrence of symptoms, and if further knee flexed, the distal SFA adopts a helical pattern to accommodate vessel slack (B). innovative work with dentures; in revascularisation is required, then the particular, he improved the compound repeat intervention is unpleasant, costly, used to take dental impressions. In a and exposes the patient to further risk. leap of imagination, Stent’s compound In addition, the clinical outcome of was used by a Dutch plastic surgeon, reintervention is poor. For the health care Johannes Fredericus Esser, to help system, the costs to manage peripheral manage horrific facial wounds in arterial disease (PAD) are substantial. the First World War. Esser used the In the United States, 12% to 15% of the material to stretch and stabilise skin population older than 65 years has PAD, grafts. This supporting mold was accounting for 8 to 10 million people; subsequently referred to as a stent, this number will only increase with an and the word is generally now used to aging population and rising prevalence of describe a device that provides support. obesity and diabetes. The 2-year hospital costs of PAD are $7,000 per patient if they only have claudication, $10,400 if the patient has an amputation, and Figure 3 CT angiogram from a cadaver showing the SFA and popliteal artery before $11,700 if the patient previously had and after placement of a conventional, straight nitinol stent. Before stent placement, revascularisation. The difference in costs arterial shortening is accompanied by a natural increase in curvature of the vessels. between these groups is largely driven After stent placement, the vessel is more rigid and can no longer accommodate the by the high costs of reintervention.5 It shortening. This results in kinking of the artery below the stent. is apparent that, for both the patient and health care system, it is extremely important to maintain patency and reduce rates of reintervention.

Courtesy of Imperial College London Benefits of Swirling Flow Figure 1 Swirling flow in the aorta. Arteries are nonplanar and three dimensional (3D) in nature, and the Arterial Stents effect produces swirling flow (Figure Stents are principally used to improve 1).6 Swirling flow creates high wall the internal lumen of a vessel before shear stress, which has been shown to be or after angioplasty. The use of protective against both the development stents has been widely successful, of atheroma and restenosis. A study and they are now ubiquitous in the published in Nature in 1969 noted that field of cardiovascular interventions. areas of high wall shear stress tend not The majority of interventions in to develop atherosclerosis.7 Later work Figure 4 Computational fluid dynamics demonstrates that the swirling flow in the the coronary arteries are now stent identified that restenosis also occurs in aorta and iliac arteries develops wall shear stress in the “protective” range (> 1.5 based, and aortoiliac stenting is areas of abnormal flow and that high Pa); however, in the SFA the lack of swirling flow results in wall shear stress in widely considered to be part of wall shear stress is protective.8-12 the “pathogenic” range (< 0.5 Pa). This correlates with the higher prevalence of the standard of care for occlusive atherosclerosis and increased restenosis rates following stent placement. disease. However, the superficial Problems With Stenting femoral artery (SFA) provides a much the SFA biomechanical incompatibility between the structural integrity of stents, resulting more challenging environment. The SFA has complex biomechanics, a conventional straight stent and the in strut fractures at rates of up to 25% at 1 which makes stent placement challenging. artery can result in kinking and occlusion year.16,17 These fractures may be associated All Stents Are Not Made Equal On knee extension, the SFA has a gentle (Figure 3).13-15 In addition, microtrauma with restenosis, arterial perforation, false The SFA is a difficult, hostile open spiral shape. During knee flexion, and abnormal flow patterns at the junction aneurysms, and distal embolisation. environment for endovascular the artery can shorten by forming a between the stent and vessel can result Given the anatomic complexity around interventions, and early attempts to use more helical pattern in the distal vessel in restenosis and atherosclerosis.13 The the adductor hiatus and the complex non-dedicated stents failed.1,2 Stents (Figures 2A and B). Conventional artery passes through the musculoskeletal mechanical loads placed upon a stent became slightly more sophisticated, as straight stents placed in the SFA are less constraints of the adductor canal into the in this area on knee flexion, it is not did physicians’ use of dual antiplatelet compliant than the normal vessel and less restrained popliteal artery. At this surprising to find that vigorous exercise agents.3,4 Randomised trials demonstrated do not accommodate this shortening. juncture, there are extreme deformations, is a predictor of stent fracture.18 Local the superiority of stenting over simple This results in additional vessel slack including axial and radial compression, hemodynamics, including the ability angioplasty, but still 12-month primary being transferred to areas of the artery bending, and torsion. This extremely to generate swirling flow, are strongly patency was low at 63% to 71%.3,4 At 2 adjacent to the stented segment. The challenging, complex junction can impact affected by the arterial morphology. BioMimics 3D is manufactured by Veryan Medical Ltd. BioMimics 3D is CE Marked. In the United States and Japan BioMimics 3D is an investigational device. CAUTION: INVESTIGATIONAL DEVICE. LIMITED BY FEDERAL (OR UNITED STATES) LAW TO INVESTIGATIONAL USE March 2016 Lower limb 37

Wall shear stress > 1.5 Pa appears to biomimetic stent that, by design, imparts improved primary patency at 2 years and be protective against atheroma and curvature, generates swirling flow, and significantly reduced clinically driven restenosis, and low wall shear stress (< leads to a vasoprotective environment TLR between 1 and 2 years.22 0.5 Pa) is related to the development (Figures 5A and B). The self-expanding BioMimics 3D is currently under of atherosclerosis and restenosis.8,11 stent is laser cut from a nitinol tube and investigation in an IDE study for the Unfortunately, the SFA possesses low has 3D helical centerline geometry set purpose of getting market approval in wall shear stress under resting conditions into the nitinol shape memory. It has an the US and Japan. (Figure 4).19 Conventional straight stents advanced technology–based design with not only further reduce any natural repeating two crown units and specific Summary curvature of the artery, but also have to connectors that allow both flexibility and Understanding the biomechanics of persist in an environment that naturally the imposition of helical geometry. The the SFA and the effects of swirling is amenable to the development of end three crowns have gradually reducing flow have led to the development of a restenosis and further atherosclerosis. radial force to improve the transition in new generation of biomimetic stent. profile from artery to stent, improve the The BioMimics 3D stent has a unique flow characteristics, and reduce the risk of design that imparts curvature to the Figure 5A poor flow and low wall shear stress that Figure 6 A CT angiogram showing the vessel, similar to that seen in nature. The BioMimics might lead to instent restenosis. maintenance of the natural curvature of In a randomised controlled trial, the 3D Stent the popliteal artery below a BioMimics clinical advantages of the BioMimics Haemodynamic and 3D stent (left) on knee flexion compared 3D stent over conventional straight Biomechanical Advantages to the kink in the popliteal artery below a stents have been demonstrated. of BioMimics 3D Versus conventional straight stent (right). Conventional Straight Prof. P.A. Gaines, MD, is from Sheffield Nitinol Stents abnormal localised flow patterns, and Hallam University in Sheffield, United The helical shape of the BioMimics 3D kinking that could otherwise lead to Kingdom. He has disclosed that he is stent facilitates artery shortening during restenosis, new atherosclerosis, and a consultant to Veryan Medical Ltd. knee flexion and manages the arterial occlusion. Swirling flow is important Prof. Gaines may be reached at slack during knee flexion resulting in in limiting restenosis. To test the effect [email protected]. less kinking at the junction between on swirling flow, a straight stent and Figure 5B stent and native vessel (Figure 6). The a helical centerline stent were placed PAM 095 Issue 01

Computational fluid dynamic ability of the BioMimics 3D stent to in opposite common carotid arteries 1. Chalmers N, Walker PT, Belli AM, et al. Randomized trial of illustration of swirling flow within resist fracture caused by extreme forces in a porcine model.21 The study the SMART stent versus balloon angioplasty in long superficial femoral artery lesions: the SUPER study. Cardiovasc Intervent a BioMimics 3D stent at the junction between adductor canal demonstrated that a 3D stent is not Radiol. 2013;36:353-361. and popliteal artery was evaluated only capable of deforming the native 2. Krankenberg H, Schlüter M, Steinkamp HJ, et al. Nitinol stent implantation versus percutaneous transluminal Biomimicry and using custom-designed, fatigue testing vessel into a helix, but also that the angioplasty in superficial femoral artery lesions up to 10 cm equipment. At that junction, there is a subsequent swirling flow significantly in length: the femoral artery stenting trial (FAST). Circulation. Harnessing the Advantages 2007;116:285-292. of Swirling Flow sudden transition from an externally reduced the development of restenosis 3. Laird JR, Katzen BT, Scheinert D, et al. Nitinol stent implantation versus balloon angioplasty for lesions in the The Biomimicry Institute describes constrained SFA to a relatively free (Figures 7A and B). The advantages superficial femoral artery and proximal popliteal artery: twelve- biomimicry as “an approach to innovation popliteal artery. This environment of this biomimetic stent were tested month results from the RESILIENT randomized trial. Circ Cardiovasc Interv. 2010;3:267-276. that seeks sustainable solutions to was reproduced in vitro by placing a in the MIMICS trial, a European 4. Schillinger M, Sabeti S, Loewe C, et al. Balloon angioplasty human challenges by emulating nature’s cylindrical constraint over a portion of multicenter, prospective, randomised, versus implantation of nitinol stents in the superficial femoral artery. N Engl J Med. 2006;354:1879-1888. time-tested patterns and strategies.” the stent. Stents between 120 and 150 core lab–controlled trial in which the 5. Mahoney EM, Wang K, Keo HH, et al. Vascular hospitalization Nature uses vessel curvature to generate mm long from multiple manufacturers BioMimics 3D stent was compared to a rates and costs in patients with peripheral artery disease in the United States. Circ Cardiovasc Qual Outcomes. 2010;3:642-651. swirling flow, elevating wall shear were evaluated during compression conventional straight stent (LifeStent) in 6. Caro CG, Doorly DJ, Tarnawski M, et al. Non-planar curvature and branching of arteries and non-planar flow. Proc R Soc Lond. stress to vasoprotective levels. Recent in the environment to 1 million load 76 patients with symptomatic occlusive 1996;452:185-197. stent designs are more flexible and seek cycles. This bench test demonstrated that disease of the SFA. Conventional 7. Caro CG, Fitz-Gerald JM, Schroter RC. Arterial wall shear and distribution of early atheroma in man. Nature. 1969;223:1159-1160. to better match or mimic the natural the BioMimics 3D stent can withstand radiographs and angiography confirmed 8. Carlier SG, van Damme LC, Blommerde CP, et al. curvature of the SFA; these are referred the highest level of axial compression that the BioMimics 3D stent imparts Augmentation of wall shear stress inhibits neointimal hyperplasia after stent implantation: inhibition through reduction of to as mimetic stents. However, all without fracture when compared to curvature to the diseased artery (Figure inflammation? Circulation. 2003;107:2741-2746. conventional straight stents, no matter the current commercially available 8). Unlike drug elution from stents 9. Caro CG. Discovery of the role of wall shear in atherosclerosis. Arterioscler Thromb Vasc Biol. 2009;29:158-161. 20 how flexible, tend to straighten blood conventional straight stents. and balloons, the imposition of arterial 10. Chiu JJ, Chien S. Effects of disturbed flow on vascular endothelium: pathophysiological basis and clinical perspectives. vessels, which reduces curvature and any The gentle transition of the BioMimics curvature is not transient but will Physiol Rev. 2011;91:327-387. naturally occurring swirling flow and 3D stent, from the gradually reducing continue to have benefit over restenosis 11. Malek AM, Alper SL, Izumo S. Hemodynamic shear stress and its role in atherosclerosis. JAMA. 1999;282:2035-2042. potentially lowers the shear stress down radial force of the end three crowns of the and atherosclerosis in the long term. 12. Qin F, Dardik H, Pangilinan A, et al. Remodeling and to pathological levels. The BioMimics stent and the native artery, is specifically Compared to a straight stent, the suppression of intimal hyperplasia of vascular grafts with a distal arteriovenous fistula in a rat model. J Vasc Surg. 2001;34:701-706. 3D stent (Veryan Medical Ltd) is a true designed to reduce microtrauma, BioMimics 3D stent had significantly 13. Arena FJ. Arterial kink and damage in normal segments of the superficial femoral and popliteal arteries abutting nitinol stents—a common cause of late occlusion and restenosis? A single-center experience. J Invasive Cardiol. 2005;17:482-486. 14. Jonker FH, Schlosser FJV, Moll FL, Muhs BE. Dynamic forces in the SFA and popliteal artery during knee flexion. Endovasc Today. 2008;7:53-58. 15. Zocholl G, Zapf S, Schild H, Thelen M. [Functional angiography of the arteries near the knee joint: consequences for stent implantation?] [Article in German]. Rofo. 1990;153:658-662. 16. Davaine JM, Azema L, Guyomarch B, et al. One-year clinical outcome after primary stenting for Trans-Atlantic Inter-Society Straight stent Consensus (TASC) C and D femoropopliteal lesions (the STELLA “STEnting Long de L’Artere femorale superficielle” cohort). Eur J Vasc Endovasc Surg. 2012;44:432-441. 17. Scheinert D, Scheinert S, Sax J, et al. Prevalence and clinical impact of stent fractures after femoropopliteal stenting. J Am Coll Cardiol. 2005;45:312-315. 18. Iida O, Nanto S, Uematsu M, et al. Effect of exercise on frequency of stent fracture in the superficial femoral artery. Am J Cardiol. 2006;98:272-274. 19. Wood NB, Zhao SZ, Zambanini A, et al. Curvature and A B 3D stent tortuosity of the superficial femoral artery: a possible risk factor for peripheral arterial disease. J Appl Physiol (1985). A B 2006;101:1412-1418. Figure 7 An angiogram of porcine common carotid arteries showing the deformation 20. Data held on file at Veryan Medical. Bench test results may not be indicative of clinical performance. that occurs after implantation of a 3D stent (right) compared to the contralateral 21. Caro CG, Seneviratne A, Heraty KB, et al. Intimal common carotid artery containing a straight stent (left). Computational fluid dynamics Figure 8 Plain radiographs hyperplasia following implantation of helical-centreline and straight-centreline stents in common carotid arteries in again demonstrates the high swirling flow and wall shear stress generated by the demonstrating the curvature imparted healthy pigs: influence of intraluminal flow. J R Soc Interface. 3D stent (A). Histology of explanted porcine common carotid arteries 4 weeks to the SFA in lateral (A) and anterior/ 2013;10:20130578. 22. Zeller T. BioMimics 3D—advanced stent design: concept after implantation of helical centerline and straight stents. The area of neointima is posterior (B) projection in a patient to randomised controlled trial. Presented at the Leipzig statistically significantly reduced after implantation of the 3D stent (B). participating in the MIMICS trial. Interventional Course (LINC); March 30, 2014; Leipzig, Germany. BioMimics 3D is manufactured by Veryan Medical Ltd. BioMimics 3D is CE Marked. In the United States and Japan BioMimics 3D is an investigational device. CAUTION: INVESTIGATIONAL DEVICE. LIMITED BY FEDERAL (OR UNITED STATES) LAW TO INVESTIGATIONAL USE 38 Lower limb March 2016 Post-atherectomy dexamethasone delivery demonstrates “strong” one-year patency data “Promising” results have been reported from the DANCE femoral or popliteal arteries and exhibited de revascularisation) while the primary safety (Dexamethasone delivered to the adventitia to enhance clinical novo or restenotic lesions of ≤15cm length. endpoint was the rate of major adverse limb efficacy) trial, studying the Bullfrog (Mercator MedSystems) delivery The Bullfrog catheter (which is FDA events out to 12 months and postoperative of anti-inflammatory GR-agonist (dexamethasone) after atherectomy 510(k) cleared and CE marked) used in death out to 30 days. Owens said that the to inhibit restenosis. this trial has a needle to infuse the drug trial ran parallel to two other trials, one a directly into the arterial wall. The drug is percutaneous transluminal angioplasty arm hristopher Owens, University of of pro-inflammatory cytokines and acute made up of 80% dexamethasone with 20% and the other an atherectomy arm. The first California, San Francisco, USA, phase reactants compared with atherectomy contrast to allow for visual confirmation 100 patients enrolled in the atherectomy arm Cpresented the data at the Leipzig alone. Owens is the national co-principal of on-target drug delivery. The primary were the focus of the presentation, of whom Interventional Course (LINC; 26–29 investigator for the DANCE trial, an efficacy endpoint was 12-month patency 73 were analysed for primary patency and January, Leipzig, Germany). He reported open-label, single-arm fully enrolled trial. (measured with duplex ultrasound and target lesion revascularisation endpoints. that post-atherectomy Bullfrog delivery All patients had reported Rutherford defined as peak systolic velocity ratio ≤2.4 The patient population was primarily of dexamethasone reduced the production classifications of 2–4 in the superficial and a lack of clinically-driven target lesion enrolled in the southern US states, reflected in the relatively high body mass index (31.6kg/m2±18.1kg/m2), high inflammation (high-sensitivity C-reactive protein [CRP] 5.2mg/dL±5.4mg/dL) and high proportion of black patients (20.5%) who generally have higher rates of re-stenosis. Lesion characteristics were “similarly challenging”, with a high representation (15.1%) of Rutherford 4 severe calcification, popliteal involvement (20.5%) and TASC II classification (36% A, 59% B and 6% C). The trial was “very safe”, with no device- or drug-related serious adverse events at one year. There were two major adverse limb events (both bypass) and five deaths at one year (but none at 30 days). Owens reported 85% primary patency at one year and 81.5% patent at 390 days. Compared to other previous trials, lesion length was relatively long, the rate of Rutherford 4 classification was high, the number of TASC II B and C lesions was high and severe calcification was more common. Despite this, the trial achieved comparable or higher 12-month patency than several of these past trials. Rutherford classification and walking impairment questionnaire scores also showed statistically significant improvement (p<0.05) at 12 months compared with the baseline screening exam. Biomarkers used were high sensitivity C-reactive protein and monocyte chemoattractive protein-1 (MCP-1). CRP levels rise in response to local triggers such as inflammation, and Owens told the audience previous studies have indicated that elevated levels are tied to restenosis. This is also the case for MCP-1, which recruits inflammatory cells to the site of injury. Significant reductions in both were seen in the 24 hours after intervention with dexamethasone when compared with existing data from non-dexamethasone interventions. In fact, after it was shown to fall by almost 50% from baseline, Owens said that “I have never seen MCP-1 go down like this.” “The early results of GR-agonist microinfusion in peripheral arteries at the time of atherectomy appear promising,” Owens said. “This makes you think about a paradigm shift in anti-restenotic thought away from the intimal delivery platforms, towards adventitial delivery of an anti-inflammatory approach,” Owens told delegates. “We think that the adventitial delivery of powerful GR-agonist therapy results in nuclear immunomodulation of the vascular injury response to reduce restenosis while permitting the unimpeded re-establishment of vascular endothelium.”

40 Updates March 2016 New drug-coated balloons outperform plain angioplasty in the femoropopliteal artery at six and 12 months Performing angioplasty with new drug-coated balloons to treat to be significantly lower in the drug-coated femoropopliteal artery disease results in lower rates of late balloon group (0.05±0.73mm) than in the lumen loss and clinically-driven target lesion revascularisation plain angioplasty group (1.15±0.89mm) compared with plain angioplasty at both six- and 12-month (p<0.001), Wei commenting that “the follow-up, according to new data. gap is huge.” The drug-coated balloon’s superior performance was repeated in he data were presented at the 2016 and importantly the average lesion length the angiographic and clinical secondary Leipzig Interventional Course of 13.2±10.4cm represents “longer lesions endpoint data, with: higher minimal T(LINC; 26–29 January, Leipzig, than in any other previously-published lumen diameter (2.38±0.89mm vs. Germany), and examined results from drug-coated balloon study,” Albrecht said. 1.16±0.96mm, p<0.001); lower restenosis the use of the SeQuent Please (B Braun) One hundred and six patients returned rate ≥50% (22.5% vs. 70.8%, p<0.001); balloon at six months and the Orchid for the six-month angiographic analysis. lower clinically-driven target lesion (Acotec Scientific) balloon at 12 months. The angiographic results showed that Thomas Albrecht revascularisation (6.1% vs. 38.98%, late lumen loss in the drug-coated p<0.001); and a higher percentage CONSEQUENT trial balloon group was 0.49±1.14mm AcoArt I trial improvement in patients’ Rutherford Thomas Albrecht, Institut für Radiologie compared with 0.98±1.01mm in the Wei Guo, Chinese PLA General class (78.6% vs. 56.8%, p=0.0012). und Interventionalle Therapie, Vivantes uncoated balloon group (p=0.017). Hospital, Beijing, China, presented Wei also shared 12-month imaging Klinikum Neukölln, Berlin, Germany, Furthermore, binary restenosis of >50% 12-month data from the 200-patient and clinical outcome data, with Doppler presented the six-month SeQuent had occurred in 21.2% of patients in the (147 male) AcoArt I trial on behalf of ultrasound analysis finding patency in Please balloon data, taken from the drug-coated balloon group compared the trial investigators. The trial is the the drug-coated balloon group of 76.1% CONSEQUENT trial, which is being with 47.2% in the uncoated balloon first Chinese prospective, randomised, compared with 33.7% in the plain conducted at eight German centres. group (p=0.005). Positive remodelling multicentre trial for the Orchid drug- angioplasty group (p<0.001). Clinically- Albrecht and colleagues were using the was observed in 36.5% of drug-coated coated balloon in treating femoropopliteal driven target lesion revascularisation rates balloon to treat steno-occlusive lesions of balloon patients, compared with 13% artery disease. The enrolled patients followed the same pattern at 12 months as the superficial femoral artery and the two in the uncoated balloon group. were randomised 1:1 to either the at six months, with the drug-coated balloon proximal segments of the popliteal artery. These positive results were mirrored Orchid balloon or plain angioplasty, (7.2%) outperforming plain angioplasty One hundred and fifty-three patients in the clinical follow-up, with target with angiographic late lumen loss at six (60.2%) (p<0.001). Late lumen loss also (104 male and 49 female, average age lesion revascularisation of 11.6% in the months as the primary outcome measure. remained notably lower in the drug- 68.1±8.7 years) were randomised 1:1 drug-coated balloon group compared Rutherford classification of all patients coated balloon group after 12 months, to either drug-coated balloon treatment with 25.7% in the uncoated balloon was 2–5, diameters of stenoses were ≥70% at -0.04±0.69mm vs. 1.69±0.71mm or plain balloon angioplasty. Follow-up group (p=0.033). The team also reported and lesion lengths were <40cm for all in the angioplasty group (p<0.001). was scheduled at six, 12 and 24 months increases in 85 patients’ walking distance patients. Lesion lengths, total occlusion “Although this trial dealt with post-procedure. The trial included patients as a secondary outcome, finding that and in-stent restenosis rates were all significantly more complex and longer with Rutherford classification 2–4, lesion the drug-coated balloon group saw an similar between the two groups. As in lesions, it demonstrates that drug-coated lengths of 4–27cm and preprocedural average increase of 137±160m, far the CONSEQUENT trial, lesion lengths balloons have a lower rate of late lumen diameter stenosis ≥70%. The primary higher than the uncoated balloon group were notably long in this cohort, with an loss and higher primary patency, as endpoint was late lumen loss at the six- increase of 71±130m (p=0.039). Target average of 14.7±10.9cm in the drug- well as a lower clinically-driven target month follow-up. Sixteen (13.5%) of the leg ankle brachial index was 0.97±0.14 coated balloon group and 15.1±10.8cm lesion revascularisation after six- and total patient population exhibited TASC for the drug-coated balloon group and in the plain angioplasty group. 12-month follow-up compared with plain C/D lesions (26 TASC C, 10 TASC D), 0.89±0.22 in the uncoated balloon group. At six months, late lumen loss was shown angioplasty,” Wei told the audience.

Tack optimised balloon angioplasty safe and effective at six months he six-month results of the TOBA to be on long-term anticoagulation regimes. feasibility and safety from the superficial the day of the procedure. BTK (Tack optimised balloon The treatments that are available lead to femoral to tibial artery with 83.3% 12-month The patient characteristics were Tangioplasty below the knee) study high technical and procedural success, but patency. The TOBA study was an above- challenging, with 87.5% of patients in the show that the Tack endovascular system also high complication rates. Angioplasty the-knee study which showed 89.5% device performance arm (n=32) classified as (Intact Vascular) demonstrated high levels of complication rates range from 3.4–51%, freedom from clinically-driven target lesion Rutherford category 5. Brodmann also noted primary patency, freedom from target lesion drug-eluting balloon complication rates revascularisation, 76.4% patency rate and that the mean age of 76.1 years made this “a revascularisation and total freedom from are around 30% and bare metal stenting 98.5% technical success rate.” very old patient population”. amputation. Marianne Brodmann, Medi- can be as high at 41.7–63.3%, Brodmann The TOBA BTK study is a first-in-man The safety sample population exhibited cal University, Graz, Austria, told Leipzig told delegates. This leads to varied one- study collecting data to support existing complex lesions. There was a broad Interventional Course 2016 (LINC; 26–29 year outcomes between these different conclusions on the Tack system’s use. anatomical distribution and >60% of patients January, Leipzig, Germany) attendees that treatment options, for primary patency (range The prospective, single-arm, multicentre had moderate or severe calcification. One Tack optimised balloon angioplasty—a new 37.9–94.7%), target lesion revascularisation study enrolled 35 patients in Europe and fifth of patients had total occlusions, lesion method for treating critical limb ischaemia (range 5.3–47%) and amputation rates (range New Zealand. All patients had critical limb lengths ranged up to 8cm and approximately with post-angioplasty dissections—may rep- 0–20%). ischaemia with Rutherford classification 80% of dissections were grade B+. resent “a new paradigm for managing dissec- The 4F Tack system is specifically for 4 and 5 and angiographic evidence of a The device exhibited “excellent safety tions with minimal metal, minimal outward below-the-knee use and is designed to post-angioplasty dissection. All had de and performance” said Brodmann. Device force and minimal injury to vessels.” achieve better healing of dissections. Its short novo lesions ≥70% stenosed/occluded success was 91.4% and procedure success Brodmann and colleagues are investigating open cell design reduces the amount of metal with reference vessel diameter 1.5–4.5mm was 97.1% in the safety sample and 96.9% use of the Tack system because they believe in the device, its flat force curve gives it a and lesions located between the knee joint in the performance sample. There were no that existing below-the-knee treatment low radial force and it is a focal treatment and ankle. Primary safety endpoint was a amputations or deaths at 30 days. There were options, such as plain angioplasty, stents, as it is used only where needed. Brodmann composite of major adverse limb events and two reinterventions, one in the safety sample atherectomy and bypass surgery, are explained that this “gives physicians periprocedural death assessed at one month. and one in the performance sample. poor. Brodmann told the audience that more control over where they treat while Device success was defined as successful Six-month primary patency by vessel was angioplasty—the “standard” treatment— maintaining normal vessel biomechanics and delivery and deployment of the device at the 86.5% and primary patency by subject was has poor outcomes and is associated with preserving future treatment options.” intended target site and successful withdrawal 87.1%, while six-month primary assisted dissections. This is also the case, she said, for Brodmann told Vascular News that “The of the delivery catheter. Procedural success patency by vessel was 94.6% and by subject treating dissections; both bare metal and drug- completion of previous trials has led to was defined as the ability of Tack to was 93.5%. Brodmann told the audience that eluting stents require multiple implants per growing clinical experience with the Tack demonstrate vessel patency as reported by the compared with six-month outcomes of alter- lesion and are susceptible to stent fractures, system. The first-in-man study was both physician without the occurrence of major native bare metal stent scaffolding options, while drug-eluting stents also require patients above- and below-the-knee, and showed adverse limb events or perioperative death on these data were comparable or superior.

March 2016

When to use intervention for deep venous thrombosis and pulmonary embolism At the 2016 Leipzig Interventional Course meeting (LINC; 26–29 January, Leipzig, iliofemoral patency at six months (65.9% vs. 47.4% for Germany), Michael R Jaff, Boston, USA, discussed the challenges facing intervention standard treatment only), Jaff explained. There were 20 for deep vein thrombosis and pulmonary embolism, and when using an interventional bleeding events, three of which were major and five of approach may be preferable. which were clinically relevant. There were no reported deaths, pulmonary emboli or intracerebral haemorrhages. hen you think about the current man- “Multiple societies” have come together to create agement of deep vein thrombosis, guidelines regarding what should be done for the “Wwhether you like it or not, most of interventional treatment for deep vein thrombosis, your colleagues—particularly the non-intervention- said Jaff. Societies such as the Society for Vascular alists—believe that this begins and ends with medi- Surgery and the American Venous Forum believe that cal therapy alone,” Jaff told the LINC audience. so far there are very little data to go on, and that the “Many physicians believe that they are experts only group in which there is a strong consideration is in the management of deep vein thrombosis,” Jaff early thrombus removal in patients with impending continued. “Their perception is that patients do venous gangrene. The American Heart Association also incredibly well with standard anticoagulation. Now, produced guidelines, on which Jaff was the first author, with novel oral anticoagulants, we do not even looking at patients “with extensive iliofemoral deep vein have to give patients injections.” Such technology thrombosis.” The guidelines suggest that “in patients who allows physicians to keep patients out of the hospital have complete or partial thrombosis of any segment of altogether, so “why incur the risks and additional the iliac vein, with or without the involvement of other costs associated with intervention?” Jaff asked. veins, you should consider intervention,” Jaff reported. An interventionalist could answer this question, “At the bottom line, we know that anticoagulation Jaff said, by looking at the goals of endovascular does not prevent the development of post-thrombotic therapy for the treatment of deep vein thrombosis. As venous insufficiency and that morbidity of post- a result of more rapid lysis via local administration thrombotic venous insufficiency is significant and of the drug, endovascular therapy relieves acute pain costly,” Jaff told the audience. “Endovenous intervention and oedema and may prevent pulmonary embolism, for deep vein thrombosis should be considered for recurrent thrombosis and post-thrombotic syndrome. iliofemoral deep vein thrombosis and patients with Vessel patency can be restored, valve function preserved advanced symptoms and low bleeding risk. You need and underlying anatomical lesions corrected. an experienced interventional team to do this.” For certain indications, endovascular intervention New guidelines were published in January 2016 is preferable, for example, in patients with extensive by “a group of multispecialty experts” in the Journal iliofemoral deep vein thrombosis or involvement of of Thrombosis and Thrombolysis which took “a far the inferior vena cava. In young, highly-functional more conservative stance on how to manage patients patients, “if you leave the clot there they are at high from an interventional standpoint,” Jaff said. These risk of being left with debilitating venous insufficiency Michael Jaff guidelines focused mainly on bleeding risk. in their middle age or later,” Jaff suggested. This “To wrap up,” Jaff discussed thrombolytics therapy for is also the case for patients with symptomatic acute pulmonary embolus. In the short-term, he said, the inferior vena cava filter occlusion, in that while Endovenous goals of such therapy are to: dissolve thromboembolic early intervention is best, the benefit may still be intervention for deep obstruction of the pulmonary arterial tree to reduce derived several months after an acute occlusion. pulmonary vascular resistance; rapidly resolve right Jaff said that endovascular intervention can also vein thrombosis should ventricular pressure overload and improve function; be suitable in patients at high risk of fatal pulmonary expedite restoration of pulmonary capillary blood flow embolism and in those with propagation of deep vein be considered for iliofemoral and effective gas exchange; quickly resolve symptoms; thrombosis despite conventional therapy. Furthermore, deep vein thrombosis and prevent early clinical deterioration and mortality in once the clot is dealt with, there is a high likelihood patients with massive and submassive pulmonary of underlying anatomical lesions, such as with patients with advanced symp- embolism; and decrease the risk of recurrent pulmonary May-Thurner syndrome, compression by a pelvic embolism by dissolving the reservoir of thrombus that tumour or prior pelvic deep vein thrombosis. toms and low bleeding risk. often remains in the lower extremities or pelvis. The Adding a mechanical device that can debulk or You need an experi- long-term goals are the prevention of chronic thrombo- remove a clot “will theoretically result in a shorter embolic pulmonary hypertension and preserving the treatment time, potentiator of the impact of thrombolytic enced interventional normal haemodynamic response to exercise. However, therapy (thereby allowing for a lower dose of the lytic team to do this. Jaff noted, “the contraindications of lytic therapy” agent) and may be an option when lysis is relatively are very important, of which “there are many”. contraindicated,” Jaff continued. Data for these concepts Jaff told delegates about a new concept; the will be reported with follow-up for the ATTRACT directed venous thrombolysis in acute iliofemoral Pulmonary Embolism Response Team, or PERT. “If (Acute venous thrombosis: Thrombus removal with vein thrombosis) study which included 209 patients you are interested in pulmonary embolus therapy adjunctive catheter-directed thrombolysis) trial—a phase with symptomatic, first iliofemoral deep vein and you like to do interventions you might make one III, open-label, multicentre randomised controlled trial thrombosis, randomised to conventional treatment decision. If you are a pulmonary/critical care physician, currently enrolling 692 patients with symptomatic and alone or additional catheter-directed thrombolysis. you might be much happier putting the patient in an acute proximal deep vein thrombosis at 28 US centres. The primary endpoints were Villalta Score at 24 intensive care unit on heparin and watching them. In The ATTRACT trial, currently in follow-up with months and iliofemoral patency at six months. our facility we created this rapid response team, which results expected to be published in early 2017, is Intervention led to a significant reduction in post- allows for immediate access of all the specialities sponsored by the US National Institutes of Health. thrombotic syndrome at 24 months (41.1% vs. 55.6% involved to help decide what to do for these very ATTRACT is “similar” to the Cavent (Catheter- for standard treatment only) and had an improvement in sick patients with serious pulmonary emboli.” vascularnews Download the app

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BIBAPublishing 44 March 2016 Which venous stent for which indication? “We still need long-term data”

Dedicated venous stents, while potentially improving treatment, are still in their first generation and lack the long-term data needed to know which stent is best suitable for which situations, according to Stephen Black, Guy’s and St Thomas’ NHS Foundation Trust, London, UK. Until such data are available, he told 2016 Leipzig Interventional Course (LINC; 26–29 January, Leipzig, Germany) delegates, venous specialists need to know about each device and its associated issues, and be aware that “the stent alone is not the panacea”.

lack told the audience that for and they all maintain patency. What the three patient groups he we are trying to do now is evolve the B treats—acute post-thrombotic, procedure to understand it better so we chronic post-thrombotic and non-oc- can improve case selection and long clusive non-thrombotic —“the stent’s term outcomes,” Black concluded. role is to maintain an adequate lumen to improve flow and to reduce pres- New venous stent sure in the leg”. In another session, Rick de Graaf, Stephen Black “When talking about stenting,” Maastricht University Medical Black continued, “we have to Centre, Maastricht, The Nether- What we are trying to do now remember that the radius is one lands, described the Venovo venous of the principal components of stent (Bard), and explained why is evolve the procedure to achieving a good clinical result. This he thinks it represents a leap for- understand it better so we is probably why, in the past with the ward in venous stent technology. use of arterial stents, where a patent “Venous stenting is becoming more can improve case selection and stent did not mean symptom relief. and more popular,” de Graaf said. This was related to the ongoing “Although it is great that so many long term outcomes. high venous pressure because the patients who were told to just learn – Stephen Black radius of those stents was too small, to live with their complaints can now which is why we saw 14mm, 16mm be treated, we need to express some “These stents will be used in and 18mm dedicated venous stents caution about venous stenting. We mainly young patients and will starting to come into the market.” have to realize that the stents remain remain there for 40 or 60 years, so “Original options were limited,” in the body for 20, 40 or even 60 years we need to know what to expect Black told the LINC delegates, and stent integrity over long time that far in the future. This is totally given arterial stents’ small-diameters is going to be a major issue. There different from arterial disease.” and relatively lower radial force are some things we cannot control “Radial force and crush (which does not imply crush completely, such as compliance in resistance are, without a doubt, resistance) when compared to the anticoagulation management, the important,” de Graaf said. “Both dedicated venous stents. Several disease extent, and haemodynamics. are higher in the Venovo stent companies have now entered the But, what we can control is the than in its direct competitors.” market with the introduction of stent; we should therefore really In contrast, flexibility of the dedicated venous stents in pursuit look for the optimal design.” Venovo is less, which is the price of improved long-term outcomes. This optimal design of a dedicated you have to pay when radial force Black explained the concept of a venous stent, he said, should include is high. The very good visibility of trade-off between having high radial easy and accurate deployment the Venovo stent might furthermore force and crush resistance versus (including being radiopaque with help to limit high radiation dose flexibility for these new stents. limited foreshortening), large and malpositioning of the stent. “You have to find the balance diameters and long lengths. Achieving The Venovo stent is tri-axial, Rick de Graaf between the two,” he said. “In the a balance between radial force and 0.035” over the wire and has venous system, the mistake we flexibility is also vital, he noted. a dual-speed thumbwheel for made was assuming a high radial The way to achieve this is customised deployment. It is a These stents force arterial stent would be good “to go back to the basics”. The self-expandable nitinol stent with enough,” he suggested. “Radial creation of the ideal venous stent six radiopaque markers at each end will be used force outwards does not equate to requires an understanding of (three tantalum and three nitinol). in mainly crush resistance; if you put a strong venous disease, computational The stent comes in diameters of stent with a high radial force into a modelling and development 8–10F and in lengths of 20–160mm. young patients and vessel crossing at the May-Thurner testing, de Graaf suggested. De Graaf showed delegates or inguinal ligament, the crush At the moment, “we really do not two successful case examples of will remain there for resistance is far more important.” understand enough” about venous Venovo use. One was for post- 40 or 60 years, so we Using case examples, Black disease, de Graaf believes. In thrombotic syndrome and the other showed that some stents start to take development of the Venovo stent, Bard was for May-Thurner syndrome. need to know what to on an oval shape, which, though has been collaborating with physicians Using angiography images, it may not be a problem in and of to overcome this knowledge gap. “A de Graaf showed the deliberate expect that far in the itself, “the reduction in radius and lot of studies are also necessary,” and controlled deployment of future. This is totally overall surface area of the stent does both analysing the existing the stent as well as its important become a problem and over time literature and using ethnographic radiopaque nature. Finally, the different these stents tend to get crushed.” and human imaging studies. cases showed how stent positioning Newer stents maintain size and shape, Animal and in vitro testing are was facilitated by the flared from arterial which is important for outflow. important, but “the most important configuration of the stent endings, disease. “All of the stents can now improve thing is durability testing,” de which was nicely demonstrated treatment. They all maintain flow Graaf told the audience. in the May-Thurner patient. – Rick de Graaf

46 March 2016 Cyanoacrylate-based adhesive study reports 97.7% closure rate at 36 months

Three-year outcomes for the VenaSeal (Medtronic) closure system show a closure rate “the same as or better” than endothermal closure, with lesser side effects than laser or radiofrequency treatment.

he data were presented at the 2016 been used for over 50 years in a wide Leipzig Interventional Course variety of medical applications. T(LINC; 26–29 January, Leipzig, The data presented at the LINC Germany) by Ulf-Thorsten Zierau, meeting regarded 886 truncal veins Saphenion Berlin-Rostock, Berlin, Ger- treated by Zierau and colleagues using many, one of the most experienced users VenaSeal since August 2015. In 619 of the VenaSeal system who has used it cases the great saphenous vein was the to treat over 1,000 varicose veins in more focus of the treatment, and in 267 it was than 550 patients. the small saphenous vein. One hundred The VenaSeal closure system is a and twenty-eight patients received minimally invasive, non-tumescent, treatment for a single truncal vein, 317 non-thermal and non-sclerosant for two truncal veins, 36 for three truncal procedure that uses a medical adhesive veins and four for four truncal veins. to close the diseased vein in patients No patients needed general anaesthesia with symptomatic venous reflux disease. and most procedures were carried out under “For the treatment of one truncal vein sedation (dormicum). Nineteen patients we use on average between 1.2–1.8mL did not need any sedation and one patient Ulf-Thorsten Zierau of glue,” Zierau told the audience. performed pain acupuncture on herself. The system does not require tumescent In 95% of cases the patients left without recanalisations were not observed “The VenaSeal system is my method anaesthesia, allowing patients to return the need for compression stockings. until month 37,” Zierau said, “giving of first choice for the treatment of to normal activity post-procedure. The Follow-up was conducted using duplex a 36-month closure rate of 97.7%.” superficial varicose veins,” Zierau told procedure eliminates the risk of nerve control over approximately 36 months. Side effects were reported in the audience. “Unlike other minimally or other heat-related injury associated Immediately post-procedure, 884 of 886 10–15% of cases. Unspecific invasive endothermal procedures, with thermal-based procedures, and veins were sealed; a closure rate of 99.8%. inflammatory reaction of tissue was you can actually speak of a gentle may reduce the need for compression After 14–30 days the rate was 98.7% due seen in 13.9% of cases (though there process for the bonding of the veins. stockings post-procedure. Furthermore, to nine partially and three completely was no phlebitis). Ecchymosis was It does not require heat, so it cannot pain scores are significantly lower than recanalised veins. At three to four months seen in 10% of cases, “especially in cause burns or nerve damage in the with laser or radiofrequency treatment post-procedure there were 12 partial and extra-anatomic subcutaneous truncal surrounding tissue. Also, a general (1.6 vs. 3.4 on the Numeric Pain Rating four complete recanalisations; a closure veins,” Zierau noted. Lymph fistula at anaesthesia is not necessary. The Scale). The material used in VenaSeal rate of 98.2%. The rate then decreased the puncture site was reported in one wearing of compression stockings is is a medical grade cyanoacrylate-based to 97.7% after six to eight months case. No hypaesthesia, paraesthesia, likewise eliminated after the treatment. adhesive capable of rapid bonding following an additional 12 partial and permanent skin reaction, phlebitis The patient can then return directly and haemostasis. Cyanoacrylates have five complete recanalisations. “Further or thrombosis was observed. back to his or her normal routine.”

EVRF system trial shows 96.8% complete occlusion at three years

“EVRF (F Care Systems) saphenous ablation is a safe and painless for teleangiectasias and spider procedure for the treatment of the greater saphenous vein and/or small veins on the face and lower saphenous vein,” according to recently released data. The authors, limbs were completed. The led by Attila Szabo, VP-Med Health and Education Centre, Budapest, authors used radiofrequency Hungary, write that “high patient acceptance and minimal postoperative treatment or combined discomfort allows a quick return to work and normal life for patients.” the treatment with liquid sclerotherapy. Facial recovery VRF is a monopolar spider vein treatments from pain reported by the patients rate was 100% and lower limb radiofrequency ablation July 2011 to March 2015 to on a visual analogue scale (2.4 recovery rate was 82% on Esystem for endothermal treat 751 saphenous reflux preoperatively, 1.2, 0.4 and average. The treatments were treatment of small, midsize and varicosity patients. 0.1 at one week, one month “well tolerated—although the and large veins. “Endovenous Radiofrequency ablation and one year postoperatively, pain level always depends procedures are far less invasive using the EVRF CR45i catheter respectively) and Venous on the patients’ current than surgery and have lower was performed on 751 limbs Clinical Severity Scores (7.7, psychic status—and the complication rates,” the authors (628 greater saphenous vein, 3.9 and 1.8 before surgery, at patient satisfaction rate was write. “The procedure is well 102 small saphenous vein one month and at one year, high,” the authors report. Attila Szabo tolerated by the patients, and and 21 for both). Complete respectively). The average Szabo and colleagues it produces good cosmetic occlusion was found in 743 patient satisfaction was 99% at suggest that “EVRF is local tumescent anaesthesia, results. Excellent clinical results of 751 cases (99%) at one one year. There were no cases appropriate for the treatment is simple and the disposable are seen at four to five years, month. At one-year follow-up, of deep vein thrombosis, skin of teleangiectasias, reticular devices are easy to use. The and the long-term efficacy of 15 of 530 patients showed burns, neuritis or bleeding. veins with the hand piece EVRF hand piece with K3i the procedure in now known recanalisation longer than 5cm “Minimal” bruising was and K3i or K6i needles (face and K6i needles proved to with 10 years of experience.” (97.2% one-year occlusion) observed at the treatment or lower leg), small varicose be useful in teleangiectasia Szabo and colleagues without clinical symptoms. The site of the tributaries in some veins or tributaries 2–5mm treatment, with excellent evaluated the effectiveness of three-year occlusion rate was cases and four patients had with the hand catheters and results,” Szabo et al conclude. EVRF treatment and analysed 96.6% (two of 59 patients had mild inflammation which for saphenous truncs and “This radiofrequency the three-year results of using an open vein segment). At one- was treated conventionally. perforators 4–15mm in diameter procedure is also suitable the device for endovenous year follow-up the investigators For smaller veins, more with the CR45i catheter.” for combination with liquid radiofrequency ablation and evaluated the postoperative than 5,000 treatment sessions “The procedure, under or foam sclerotherapy.” March 2016 47 Hybrid operative thrombectomy is non-inferior to percutaneous techniques for acute iliofemoral deep vein thrombosis treatment

ybrid operative thrombectomy study enrolled 71 patients with acute/ PRBC units postoperatively than the hybrid is a novel technique for the subacute iliofemoral deep vein thrombosis operative patients (p=0.07) and had a Htreatment of acute iliofemoral in a single limb. Patients were treated with significantly longer length of stay (10 vs. deep vein thrombosis. All components either the hybrid operative thrombectomy 13.3 days, p=0.05) when compared to the of the technique are employed through ± balloon angioplasty and/or stent (n=40) hybrid operative group. Major bleeding a single femoral venotomy (single inci- or catheter-directed thrombolysis ± complications (3 vs. 8 events, p=0.04) sion), with retrograde manipulation to pharmacomechanical thrombectomy were more common in the percutaneous the distal vein segments and avoidance (n=31). The demographics of the two group. At intermediate follow-up there of arteriovenous fistula as the major dis- groups were similar in terms of gender, was no difference between the two tinguishing factors from contemporary body mass index and deep vein thrombosis groups in mean reflux times (1.56 vs. 1.51 operative approaches. The technique site, although they differed in age (hybrid seconds, p=0.81) at the femoral-popliteal was developed by Jorge Martinez- operative thrombectomy group 56.5±16.1 segment. At a mean follow-up time of Trabal, who is the senior author in the years, percutaneous group 49.5±16.5 years). 1.5 years the clinical CEAP classification study. Hybrid operative thrombectomy Perioperative outcomes, technical at the surgical limb was 3 or less in the achieves complete thrombus resolution Limael Rodriguez success (>50% thrombus resolution), majority of patients in both groups. in one operating room trip which results and thrombus resolution (partial vs. “In our experience, percutaneous in reduced length of stay, bleeding removal have gained favour over the past complete) were analysed between technique and the hybrid operative complications and transfusions when 10–15 years,” Rodriguez said, “which the two treatment groups. CEAP technique have demonstrated very compared with percutaneous treatments is directly related to better techniques, classification, Villalta score and good outcomes in the perioperative that use thrombolytic therapy. This can better technology, and overall better venous duplex at intermediate and intermediate periods,” Rodriguez be achieved without sacrificing success- skills, as well as a better understanding follow-up were also analysed. explained. “The hybrid operative ful clinical or duplex results, accord- of the pathophysiology of the disease.” Rodriguez et al found that the left approach is non-inferior to a ing to data presented at the American There are two treatment methods that can limb was the most common site of the percutaneous approach as a technique Venous Forum (AVF; 24–26 February, be employed. The first are percutaneous deep vein thrombosis in both groups. for early thrombus removal, and has Orlando, USA). techniques which in general encompass Technical success was 100% in both the advantage that thrombolytic therapy Limael Rodriguez, St. Luke’s Memo- the use of thrombolytic infusion. This groups, and at least 80% thrombus is not required, thrombus resolution rial Hospital, Ponce, Puerto Rico, USA, is most commonly achieved with resolution in all patients treated with the is established in one operation, told AVF delegates that “Although catheter-directed thrombolysis, with or hybrid operative technique. There was and length of stay is significantly the best treatment for thrombus re- without (±) the addition of pharmaco- a trend towards a greater postoperative decreased.” Rodriguez was awarded moval remains unclear, hybrid operative mechanical thrombectomy via a device. percentage drop in haemoglobin in the the 2016 Servier Traveling Fellowship thrombectomy definitely has fewer major The second option is a mechanical percutaneous treatment group (17% vs. for best study by a resident or bleeding events when compared with thrombectomy via an operative approach, 23%, p=0.07) which almost reached fellow at the AVF, and will present thrombolytic infusion.” which avoids thrombolytic infusion. statistical significance. Percutaneous the study at the European Venous “Techniques for deep vein thrombus Rodriguez and colleagues’ cross-sectional treatment patients were transfused more Forum (7–9 July, London, UK).

March 2016 49 Systemic thrombolysis for acute pulmonary embolism increases stroke risk compared with catheter-directed intervention Although systemic thrombolysis achieves similar rates of risk, and haemorrhagic stroke risk. “baseline characteristics of the mortality as catheter-directed intervention for the treatment Of the 263,955 acute pulmonary matched cohorts did not differ sig- of acute pulmonary embolism, it also carries “significantly embolism patients, 1.63% (n=4,272) nificantly using standardised differ- increased odds of intracranial haemorrhagic complications,” received systemic thrombolysis and ence comparisons,” Liang reported. according to data presented at the American Venous Forum (AVF; 0.55% (n=1,455) received catheter-di- Furthermore, Liang and colleagues’ 24–26 February, Orlando, USA). rected intervention. Systemic throm- analysis of the matched cohorts did bolysis patients were older, had more not demonstrate a significant ef- athan Liang, University of temic thrombolysis. This study was a chronic comorbidities, and higher fect of catheter-directed intervention Pittsburgh Medical Center, short-term exploratory comparative rates of respiratory failure (27.9%, on in-hospital mortality or overall N Pittsburgh, USA, told the analysis comparing the two methods. n=1,192; vs catheter-directed throm- bleeding risk. Liang did note that audience that acute pulmonary em- Liang and colleagues identified pa- bolysis: 21.2%, n=308; p<0.001) and the analysis did show “a significant bolism is the third leading cause of tients presenting with acute pulmonary shock (systemic thrombolysis: 18.2%, protective effect against haemor- cardiovascular mortality, accounting embolism in the National Inpatient n=779; catheter-directed interven- rhagic stroke offset by an increased for 5–10% of all in-hospital deaths. Sample from 2009–2012 (n=263,955). tion: 12%, n=174; p<0.001). Catheter risk of procedural bleeding com- Current treatment strategies include Comorbidities, clinical characteristics, patients saw higher rates of concur- pared to systemic thrombolysis.” anticoagulation, surgical thrombec- and invasive procedures were identi- rent deep venous thrombosis (sys- Subgroup analysis showed de- tomy, systemic thrombolytics and fied using International Classifica- temic thrombolysis: 35.8%, n=1,530; creased odds of haemorrhagic stroke catheter-directed interventions. tion of Diseases version 9 (ICD-9) catheter-directed intervention: 45.9%, for catheter-directed intervention Catheter-directed interventions, codes and the Elixhauser comorbid- n=668; p<0.001) and vena cava filter in the non-shock subgroup, and Liang explained, are a relatively ity index. To adjust for anticipated placement (systemic thrombolysis: increased procedural bleeding, recent treatment alternative. Bleeding baseline differences between the 31.1%, n=1,328; catheter-directed in- but no difference in haemorrhagic risk rates as low as 2.5% have been two treatment groups, propensity tervention: 57%, n=830; p<0.001). In stroke risk in the shock subgroup. reported with this approach, as has score matching was used to create the unmatched cohort, systemic throm- “Systemic thrombolysis for acute significant postoperative echocardio- a matched systemic thrombolysis bolysis patients had higher in-hospital pulmonary embolism may not improve graphic right ventricular improve- cohort with clinical and comorbid mortality (16.7%, n=714; catheter- in-hospital mortality, but increases ment. However, there are “limited characteristics similar to the catheter- directed intervention: 9.4%, n=136; the overall risk of haemorrhagic or conflicting” data for mortality or directed intervention cohort. Sub- p<0.001) and haemorrhagic stroke stroke compared to catheter-directed clinical benefits, bleeding compli- groups of patients with and without rates (2.2%, n=96; catheter-directed intervention,” Liang concluded. cations or cost of catheter-directed haemodynamic shock were analysed intervention: 1.4%, n=20; p=0.041). “Further prospective studies should interventions, Liang said, with no separately. Primary outcomes were After propensity matching, 1,434 examine the comparative effectiveness head-to-head comparisons with sys- in-hospital mortality, overall bleeding patients remained in each cohort; and safety of these two treatments.” 50 Market watch March 2016

The everlinQ endoAVF is designed to create an arteriovenous fistula for haemodialysis using an endovascular approach via catheter-delivered Product News radiofrequency energy. The technology received CE mark in 2014, and recently the company announced positive primary endpoint data at the Leipzig Interventional has FDA consent to enrol up to 10 patients, will assess Course (LINC; 26–29 January, Leipzig, Germany) from the safety of the device implantation procedure in a prospective, multicentre clinical study evaluating the the treatment of aortic aneurysms encroaching on or everlinQ endoAVF system. TVA Medical will begin involving visceral branch vessels. controlled commercialisation efforts and a post-market “These trial results are remarkably similar to study in Europe this year. The everlinQ endoAVF system government-funded randomised trials, and have is not currently available in the USA and has not been established certain benefits of these minimally invasive evaluated by the US Food and Drug Administration. therapies to improve the health of patients. Further, in the USA OVER trial, endovascular repair reduced total healthcare costs,” says Jon Matsumura, professor and chairman, Division of Vascular Surgery at the University of Wisconsin School of Medicine, USA and public health and national principal investigator of the initial E-ventus BX device clinical trial. With more than 3,000 patients enrolled in the Gore Jotec launches new E-ventus BX Global Registry for Endovascular Aortic Treatment peripheral stent graft (GREAT), data has been collected since August 2010 In January, Jotec launched a new E-ventus BX balloon- on patients treated with the Gore Excluder AAA expandable peripheral stent graft system. The device endoprosthesis as well as the Gore TAG thoracic is indicated for interventional therapy in renal and endoprosthesis, conformable Gore TAG thoracic iliac arteries in cases such as ruptures, dissections and endoprosthesis, and most recently, the Gore Excluder aneurysms. According to Jotec, “to meet the highest iliac branch endoprosthesis. A total of 5,000 consecutive demands of interventional therapies the cobalt- patients from up to 300 worldwide sites are to be chromium stent structure, as well as the ePTFE layer, enrolled in the registry, and their treatment results were reinforced and both stent ends are now fully should be tracked for 10 years. ePTFE encapsulated.” In a press release, Jotec stated that “the E-ventus BX Stentys below-the-knee drug-eluting stent offers maximum stent graft flexibility to conform to to be distributed commercially in Europe native vessel’s curvature”. The stent graft consists of a microporous, single-layer ePTFE and a unique cobalt- chromium stent design for high radial strength together with MRI compatibility. The E-ventus BX stent graft can be deployed to the specified diameter with minimal recoil and foreshortening and is securely anchored within the target vessel. The very flexible delivery system facilitates advancement into the vessel for safe and convenient Altura stent graft deployment with a low profile of 6F for 5mm and 6mm stent grafts and 7F for 7mm to 10mm Lombard Medical announces first stent grafts. The stent graft is available in lengths from commercial Altura endovascular stent 18mm to 58mm in several steps. The E-ventus BX is graft procedure commercially available in Europe. Stentys The first commercial procedure using Lombard Medical’s new Altura endovascular stent graft has been completed Over 250,000 patients treated with Gore The fist distribution agreements in Germany and at University Hospital of South Manchester (UHSM), Excluder abdominal aortic aneurysm Belgium for the Stentys drug-eluting stent for treating UK. The hospital is a major endovascular aneurysm endoprosthesis below-the-knee arteries were announced by the repair (EVAR) centre within the NHS, servicing more More than 250,000 patients have been treated with company in February. This makes the product the first than 180 EVAR patients annually. the Gore Excluder abdominal aortic aneurysm drug-eluting stent commercialised for this indication in “Endovascular aortic repair is the standard of care endoprosthesis, Gore has announced. This marks a Europe, according to Stentys. for patients requiring intervention for abdominal aortic significant milestone for the device, which received the The Stentys stent obtained CE marking for the aneurysm. The new Altura stent graft from Lombard CE mark in 1997, and FDA approval in 2002. below-the-knee indication at the end of 2015 following significantly simplifies what can be a complex procedure “Since completing the initial clinical trial, we have the excellent results achieved by the PES BTK-70 while offering increased accuracy and control in stent made one modification to the Gore Excluder AAA study, where it prevented amputation in 99% of the 70 graft deployment,” said Jonathan Ghosh, consultant endoprosthesis design by adding a low-permeability film patients treated for critical limb ischaemia. The rapid vascular and endovascular surgeon at UHSM. layer to the graft,” says Ryan Takeuchi, Aortic Business launch of its commercialisation reflects a major medical “We are now able to perform same day aortic aneurysm unit leader at Gore. need, particularly in Germany, Europe’s largest market, repair and the new Altura device should benefit both The Gore Excluder abdominal aortic aneurysm according to a company release. the patient and hospital with its 14F ultra low profile (AAA) endoprosthesis is a minimally invasive treatment design, predictable procedure times and greatly reduced option for patients with abdominal aortic aneurysms, TVA Medical receives additional inventory requirements,” added Dare Sereki, consultant featuring active infrarenal fixation and designed to reimbursement in Germany for everlinQ vascular interventional radiologist at UHSM. provide migration resistance. According to a company endoAVF system “Our first commercial procedure is an important step in release, the device also features exceptional limb TVA Medical’s everlinQ endoAVF system has executing our Altura commercial strategy,” said Lombard performance due to the unique combination of expanded received NUB (German Neue Untersuchungs und chief executive officer Simon Hubbert. “With the official polytetrafluoroethylene (ePTFE) graft material and fully Behandlungsmethoden) Status 1 approval across more launch at the Leipzig Interventional Course (LINC; 26–29 supported, nested, nitinol stent design to prevent kinking than 80 leading hospitals in Germany. January, Leipzig, Germany), we are looking to build on and occlusion. A presentation at the 2015 Vascular The approval was granted under the German Institute the physician interest and excitement surrounding Altura Annual Meeting featured a meta-analysis of several for the Hospital Remuneration System (InEK) NUB and expand our launch in the UK and German markets.” endovascular aneurysm repair (EVAR) devices that programme for facilitating the introduction of new and showed the Gore Excluder device limbs have the lowest innovative medical technologies. The designation of NUB Huntleigh releases Dopplex ankle and incidence of occlusion at both one and three years. Status 1 is the highest level available, and entitles the kit and Dopplex DMX digital Gore recently announced the first US implantation more than 80 hospitals with NUB approval to negotiate vascular Doppler of the Gore Excluder thoracoabdominal branch with insurance companies for additional funding to cover Huntleigh has launched the Dopplex ankle and toe endoprosthesis. This initial feasibility study, which the cost of the everlinQ endoAVF system. pressure (ATP) kit. This comprises the company’s

52 Market watch March 2016

invasive 0.8” Passeo-18 Lux platform. The randomised, controlled BIOLUX P-I clinical trial established the safety and efficacy of the Passeo-18 Lux Product News paclitaxel-coated balloon catheter in treatment of peripheral arterial disease (PAD). These results, published in the Journal of Endovascular DMX Doppler, probes and accessories to aid the to 24F sheath. With immediate haemostasis, and a device Therapy, are comparable to other scientific data suggesting vascular, diabetic or lymphatic specialist with the deployment time of 1–2 minutes, operators are seeing 20-30 that DCB is a viable treatment option and has the potential assessment of arterial disease and neuropathy. minutes or greater savings in total procedure time when to become standard of care in the superficial femoral artery, By swapping the Doppler probe with a compared to suture mediated closure devices. There were according to a Biotronik press release. plethysmography (PPG) adaptor, the arterial PPG zero (0%) minor device-related vascular complications, and Unlike other DCBs, use of Passeo-18 Lux in infrapopliteal probe can be used to easily undertake toe brachial one major (2%) device-related vascular complication. arteries is also supported by promising data from the multi- index measurement. This optical sensing system Lead investigator Nicolas Van Mieghem, medical centre, randomised, controlled BIOLUX P-II first-in-human placed directly on the toe is designed to provide a far director of the Department of Interventional Cardiology at clinical trial, published in the Journal of American College of quicker and more accurate measurement than Doppler. the Thoraxcenter, Erasmus Medical Center, Rotterdam, the Cardiovascular Intervention in October 2015. Netherlands comments, “Access management becomes First results showed a trend towards more favourable faster, safer and reproducible in the hands of many more outcomes for patients treated with Passeo-18 Lux DCB operators.” as compared to conventional percutaneous transluminal Azeem Latib, San Raffaele Scientific Institute and angioplasty. At six months, primary patency for Passeo-18 Columbus Hospital, Milan, Italy finished the study with Lux patients was 82.9% vs. 73.9% in the angioplasty group. his 12th Manta case. He states “Manta is very easy to use Fifty-nine per cent of patients improved in Rutherford for everyone. I can teach you how to use Manta effectively classification in the DCB group vs. 47% in the control within two to three cases. And the haemostasis is immediate. group. Finally, patients in the DCB group did not experience No oozing, just perfect. Compared to what is currently any major adverse events at 30 days, and had a low major offered, there is no comparison.” amputation rate at 12 months: 3.3% vs. 5.6% in the control Jan van der Heyden, St. Antonius Ziekenhuis, Niewegein, group. The Netherlands comments, “Manta should become “Effective treatment of infrapopliteal arterial disease is a mantra when performing transcatheter aortic valve quite challenging as it involves high-risk patients with severe implantation (TAVI). The Manta is very intuitive to use and comorbidities and critical limb ischaemia, poor prognosis provides instant haemostasis. It is a great asset in the lab and and considerable mortality rates,” states BIOLUX P-II will make transcatheter aortic valve replacement (TAVR) investigator and main enroller Marianne Brodmann, Medical cases even more successful going forward.” University Graz, Austria. “Unfortunately, there are a lack of Gary Roubin, Essential Medical’s chief medical officer, study data available regarding use of DCB in this complex comments, “Operator acceptance and outcomes allowed area, and results have been somewhat contradictory. The Essential Medical to complete our EU Manta Study ahead of results of the BIOLUX P-II trial are, however, encouraging. schedule.” During the trial, Passeo-18 Lux paclitaxel-coated balloon Manta is a novel vascular closure device designed to close catheter demonstrated safety and performance in the punctures ranging from 10F to 24F at femoral arterial access treatment of stenosis, restenosis and occlusion below the sites after cardiac catheterisation procedures such as TAVR, knee.” Dopplex ankle and toe pressure kit endovascular treatment of abdominal aortic aneurysms, Use of Passeo-18 Lux for below-the-knee indications ventricular assist, and balloon aortic valvuloplasty. will continue to be investigated, as the BIOLUX P-III The new high resolution colour display is designed These procedures are the fastest growing segment of the Global All-comers Registry plans to enrol over 700 patients, to work both as a visual aid for optimum deflation cardiovascular market. Closure of large bore femoral access including a dedicated below-the-knee indication subgroup. rate and determination of systolic pressures. PPG sites has been associated with significant morbidity including BIOLUX P-III is currently enrolling patients in Europe and waveforms and pressures can be stored on the internal long times to achieve haemostasis, extended procedure Asia Pacific. memory or SD card and reviewed at any time. time, need for a vascular surgeon in the catheterisation The company has also launched the Dopplex DMX lab, delayed ambulation, higher rate of complications and Nipro Medical launches Cronus HP high- digital vascular Doppler. According to a company higher total cost of care. Manta was designed to address the pressure angioplasty balloon catheter in the release, this Doppler combines audio clarity and complexities of closing large punctures in high-pressure USA a visual representation of waveforms with high vessels utilising novel closure technology. Manta’s fail-safe Nipro North America, a division of Nipro Medical performance probe sensitivity. deployment provides immediate haemostasis in order to Corporation, has launched the Cronus HP high- The product is can be charged via a USB , and reduce complications associated with large bore closure. pressure, 0.035” over-the-wire percutaneous can transfer electronic records to a computer using A CE mark submission is currently being prepared with transluminal angioplasty balloon catheter. Bluetooth communication. It also houses an SD card expected commercial approval in mid-summer. Essential Cronus HP is indicated for percutaneous transluminal to store measurements for review and transfer. Medical is in the process of submitting an investigational angioplasty in the femoral, popliteal, iliac and renal Bi-directional waveforms are generated from the device exemption application to the US Food and Drug arteries and for the treatment of obstructive lesions digital Doppler spectrum, and presented on a high Administration for a US pivotal study of Manta. in native or synthetic arteriovenous dialysis fistulae. resolution display with wide viewing angle. This is This is the latest product offering from Nipro’s designed outperform other Dopplers in the gathering Smaller diameters of Biotronik Passeo-18 interventional division that will see a number of of objective evidence to assist clinicians in the Lux drug-coated balloon receive CE mark further launches throughout 2016 and 2017. diagnosis of vascular. CE mark approval has been granted to Biotronik for smaller Cronus HP achieves an average rated burst pressure of Audio clarity is enhanced with Huntleigh’s diameters of the Passeo-18 Lux drug-coated balloon (DCB). 26 atmospheres across the entire size matrix. This semi- Dynamic Digital Noise Reduction (DDNR) system, The new sizes—2mm and 2.5mm—are designed to facilitate compliant balloon provides flexibility at high pressure, while according to the company. DDNR is designed to DCB treatment of below-the-knee arteries. minimising balloon elongation and the “dog bone” effect, eliminate background hiss and crackle noise when The products are intended for use with the minimally Nipro says. The combination of high pressure, flexibility and moving the transducer in the search for blood vessels. durability allow Nipro to deliver a product that addresses This should facilitate the assessment of small and the limitations of conventional high pressure percutaneous diseased vessels. transluminal angioplasty balloons. Cronus HP is intended to treat arteriovenous fistula stenoses ranging from Essential Medical completes enrolment simple, focal, venous outflow strictures to more complex of EU clinical studies for Manta large bore juxta-anastomotic obstructions in early fistula failures. vascular closure device “Cronus HP provides physicians with a high-pressure Essential Medical has completed enrolment of its European angioplasty balloon catheter, specifically designed to CE mark clinical study of Manta, the company’s large bore successfully balloon the most resilient stenoses that are vascular closure device. typically resistant to expansion, while being flexible enough Preliminary results from the single arm, 50 patient to conform to natural vasculature of native fistulae. This study show that Manta successfully achieves immediate is particularly important at and across the anastomosis, haemostasis in the femoral arterial access site in patients where less vessel straightening leads to minimal vascular undergoing percutaneous large bore procedures using a 14F Passeo-18 Lux damage and superior outcomes,” said John O’Connor, March 2016 Market watch 53

peripheral arterial disease. Avinger will commence US commercialisation of this enhanced version of Pantheris immediately, which the company says Product News features improved ergonomics, physician controls and manufacturability. Lumivascular technology utilised in the Pantheris system national sales manager for Nipro’s Interventional Division. the national Gore Excluder iliac branch device clinical allows physicians to see from inside the artery during Cronus HP features laser bonding at critical flex points study. “However, through our research and the subsequent a directional atherectomy procedure by using optical and low profiles along its catheter shaft, which help achieve FDA approval, physicians now have a new therapeutic coherence tomography (OCT). In the past, physicians have superior trackability and pushability over guidewires. In option to preserve pelvic perfusion in order to improve had to rely solely on X-ray as well as touch and feel to addition, its tri-fold pleat technology allows for crossability clinical outcomes and maintain patient quality of life.” guide their tools while they try to treat complicated arterial in highly stenosed lesions and enhanced re-cross whenever The iliac branch endoprosthesis system disease. With the lumivascular approach, physicians can multiple inflations might be required in resilient stenoses. provides a treatment range of 6.5–13.5mm for more accurately navigate their devices and treat peripheral Cronus HP is a 0.035” guidewire system available the internal iliac arteries, and a treatment range arterial disease lesions, thanks to the OCT images they see in a wide range of lengths and diameters to treat focal, of 6.5–25mm for the external iliac arteries. The from inside the artery, according to an Avinger press release. as well as diffuse arteriovenous fistula stenoses. delivery profile of the loaded catheter allows “Atherectomy is a proven treatment that relieves the use of a 16F introducer sheath for the iliac pain and restores blood flow, and Pantheris has been Gore Excluder iliac branch endoprosthesis branch component, and a flexible 12F, reinforced eagerly anticipated in the clinical community because it granted FDA approval introducer sheath for the internal iliac component. is a leap forward in atherectomy technology compared The Gore Excluder iliac branch endoprosthesis (IBE) The Gore Excluder iliac branch device clinical to what we have had in the past,” said Thomas Davis, has become the first off-the-shelf aortic branch to be study, a prospective, multicentre, non-randomised, of St John Hospital and Medical Center in St Clair approved by the US Food and Drug Administration single-arm study designed to assess the safety and Shores, USA. “Now, for the first time, we are able (FDA) according to a company release. effectiveness of the IBE in treating common iliac to see exactly where we are removing the plaque, The product is now the only device indicated for the artery aneurysms or aortoiliac aneurysms, completed and are better able to leave the healthy artery alone. endovascular treatment of common iliac artery aneurysms or enrolment in February 2015. A total of 62 patients Clinical data suggests that the precision offered aortoiliac aneurysms. The system received CE mark in 2013. received the device, which met the FDA required with Pantheris will have a lasting positive effect on Like other Gore endoprostheses, the device is designed enrolment of 60 patients. The trial has also enrolled patient outcomes. In addition, Pantheris visualises expanded polytetrafluoroethylene (ePTFE) graft and an additional 32 patients through continued access the artery without requiring ionising radiation. nitinol stent material, which should offer durability. (as of February 15, 2016), which has expanded Thus, OCT has the potential to reduce physician The IBE is an all-in-one system, offering improved treatment options to allow for bilateral placement of and patient X-ray exposure, which is a concern for outcomes for the treatment of iliac artery aneurysms while the IBE in addition to unilateral IBE device placement, all clinicians performing multiple procedures.” preserving flow to the iliac arteries, according to the release. which was evaluated in the primary enrolment. Pantheris has demonstrated clinical effectiveness “Historically, options to preserve flow to the internal and a positive safety profile. In the recently completed iliac arteries during endovascular aneurysm repair were Avinger announces FDA clearance and US VISION study, 130 patients were treated with Pantheris very limited despite the involvement of the iliac arteries launch of enhanced Pantheris system and followed for a period of six months. The study in about 25% of abdominal aortic aneurysm cases,” says Avinger has received 510(k) clearance from the achieved its primary safety and efficacy endpoints Darren Schneider, chief of Vascular and Endovascular US FDA for an enhanced version of its Pantheris and showed a target lesion revascularisation rate of Surgery and associate professor of surgery at Weill Cornell lumivascular atherectomy system, an image- 8%, and no vessel perforations, clinically significant Medicine, New York, USA, and principal investigator for guided atherectomy device for the treatment of dissection or late aneurysm resulted from Pantheris.

March 2016 Studies 55

success, rate of major adverse events, duplex ultrasound findings, quality of life, six-minute walk test, wound status, economic outcomes and development of plaque Clinical News burden assessment. With enrolment now complete, key baseline demographic data were presented at ISET on 9 February Washington, USA, as part of his physician-spon- by Jihad Mustapha of Metro Health Hospital in sored investigational device exemption study. Wyoming, USA, and George L Adams, Rex Healthcare, The AortaFit system comprises Aortica’s Fen- Raleigh, USA. estration Alignment software, and a patient- Mustapha says, “One hundred patients with severe specific 3D-printed fenestration template. critical limb ischaemia (Rutherford class 6), the most In both surgeries, the presence of branch arteries near life-threatening form of peripheral arterial disease, the aneurysms and angulated patient anatomy limited were included in this study. These data may provide the available treatment options. Using only a CT scan, unprecedented evidence that these difficult-to-treat the Aortica software analysed each patient’s native aorta patients can be successfully treated. We look forward to and determined how each endograft would influence the sharing this information with the scientific, medical and vessel geometry once implanted. Using this informa- patient communities.” tion, the software precisely determined the appropriate Adams adds, “LIBERTY 360°, the largest all-comers Valiant TAAA stent graft system locations of fenestrations (or holes in the graft) to align endovascular-peripheral arterial disease study, includes with the branch arteries. A 3D printer then generated four core labs to help physicians adequately personalise First patient treated with Valiant patient-specific AortaFit templates which were used in the treatment options.” thoracoabdominal aortic aneurysm operating room to guide the modification of each graft. The interim LIBERTY demographic analysis indicates stent graft in clinical study Standard “off-the-shelf” Medtronic and Bolton Medical that the prevalence of diabetes and renal disease Medtronic and Sanford Health announced on 9 Febru- endografts were used in these first two cases. By account- increases statistically as the peripheral arterial disease ary 2016 the first patient enrolled in a clinical study ing for the branch arteries, the grafts provided a more state progresses from Rutherford 2–3 (claudicant) to using the Medtronic Valiant thoracoabdominal aortic secure fixation and seal while still allowing for blood to Rutherford 6 (critical limb ischaemia). aneurysm stent graft for minimally invasive repair of continue flowing to vital organs fed by the branch arteries. The data indicates racial disparity in peripheral arterial thoracoabdominal aortic aneurysms. The procedure Starnes says, “The Aortica software made case disease/critical limb ischaemia treatment, which warrants was performed by Patrick Kelly, through a physician- planning so much easier and the AortaFit template further investigation, according to a company release. sponsored, investigational device exemption, approved shortened the time for graft modification in the operat- by the FDA. Kelly, a physician and inventor who leads ing room. Our first case was a 74-year-old male with Single-centre comparison of drug- Sanford Vascular Innovations, reports the patient was a a 6cm juxtarenal aneurysm. The arteries that supplied coated balloons presented at LINC 58-year-old female with few alternative medical options his kidneys were only 7mm from the beginning of the Two drug-coated balloons with proven efficacy in for treatment of her aneurysm. aneurysm, meaning there was not adequate space to prior randomised controlled trials show no signifi- “The mortality rate is 25% when treating a thoracoab- anchor a standard endograft,” continues Starnes. cant different for target lesion revascularisation and dominal aortic aneurysm with an open surgical technique, “Using the AortaFit System, we generated a three- sustained clinical improvement in real-world data, which involves cutting open the aorta. Providing the patient fenestration template that precisely matched the according to Sabine Steiner, Division of Interven- with an option for a less-invasive approach is needed,” anatomical requirements of our patient. I was able to tional Angiology in University Hospital Leipzig, said Kelly. “This procedure marked an important step in very quickly and easily modify a standard Medtronic Germany. the process to obtain FDA approval, and Sanford’s support Endurant II endograft. The alignment of the fenestra- Steiner presented results of an investigator- of such innovation will give hope to patients afflicted with tions was perfect; the graft was easily placed and we sponsored and funded retrospective, single-centre challenging disease states such as this.” increased the effective seal zone from 7mm to 39.2mm. study comparing real-world patients with complex The Valiant thoracoabdominal aortic aneurysm stent The entire procedure took 1 hour and 53 minutes.” femoropopliteal lesions treated with Lutonix graft system is intended to allow for an off-the-shelf “The second case was also a 74-year-old male who (Bard) and IN.PACT (Medtronic) drug-coated endovascular solution to one of surgery’s most difficult underwent open surgical repair six years earlier,” Starnes balloons at the Leipzig International Course pathologies. The device garners broad attention as phy- continues. “Unfortunately his disease continued to (LINC; 26–29 January, Leipzig, Germany). sicians search for options to treat patients with severe progress. The aneurysm had grown to 6cm, and was The comparison included 575 limbs and 456 and challenging aortic disease. now located just 2mm from arteries branching out to the patients undergoing femoropopliteal intervention “The Valiant thoracoabdominal aortic aneurysm kidneys. Again the AortaFit system was used to quickly (IN.PACT n=398; Lutonix n=177) between June approach allows for the procedure to be staged at any determine the location of three fenestrations, and to guide 2013 and December 2014. The analysis consisted time and lets the operator work on each branch vessel modification of a standard Bolton Medical endograft, of pre-scheduled clinical follow-up visits at six and individually,” said James Black III, chief of the Division enabling the patient to be treated endovascularly while 12 months, and yearly thereafter, and telephone of Vascular Surgery and Endovascular Therapy at Johns increasing the effective seal zone from 2mm to 35.3mm.” contact for assessment of clinical and vital status. Hopkins Hospital. “When taking on challenging cases, Clinical follow-up included deaths, target lesion the device leverages skill sets that are quite routine for Cardiovascular Systems reports revascularisation and Rutherford classification. vascular surgeons.” LIBERTY 360° demographic data at The analysis showed 22 deaths, 11 in each group. “The novel device is customisable and diverse,” said ISET 2016 The freedom from target lesion revascularisation Thomas Naslund, chief of the Division of Vascular Cardiovascular Systems has presented baseline rate was 73.1±3.7% at 18 months (number at Surgery at Vanderbilt University Medical Center. “It is demographic data from its LIBERTY 360° post- risk=90) in patients treated with Lutonix, and critical that our field focus on innovative ways to treat market study in a late-breaking presentation at the 28th 74.8±4% (number at risk=44) in patients treated these kinds of aneurysms.” International Symposium on Endovascular Therapy with IN.PACT (p=0.9). Improvement in Rutherford A concept for the novel Valiant thoracoabdominal (ISET) in Hollywood, USA. class was observed at 18 months in 66.4±4.1% aortic aneurysm system was first described in the No- The study completed its enrolment on 1 February 2016, of the patients treated with Lutonix (number at vember 2014 issue of the Journal of Vascular Surgery. and will evaluate the acute and long-term clinical and risk=77) and in 59.5±4.2% of the patients treated Kelly developed the concept for the system and has economic outcomes of endovascular device interventions, with IN.PACT (number at risk=41) (p=0.2). since collaborated with Medtronic. Sanford Health holds including CSI’s orbital atherectomy system, in treating Steiner highlighted the fact that there was the intellectual property covered by the exclusive patent peripheral arterial disease. no significant difference for reintervention and license agreement with Medtronic. Medtronic plans to LIBERTY 360° is a prospective, observational, sustained clinical improvement with the devices, study the system in collaboration with physicians at sev- multicentre post-market study that enrolled over 1,200 in real-world data, but said that the analysis has eral medical centres, including Kelly at Sanford Health. patients at 53 sites across the USA, including 500 patients the limitations of a non-randomised, single-centre in the claudicant Rutherford class 2–3 arm, 600 in the cohort study design. “Head-to-head comparisons First two fenestrated EVAR procedures critical limb ischaemia Rutherford class 4–5 arm and 100 are preferred but are not available,” she said. performed with the Aortica AortaFit in the critical limb ischaemia Rutherford class 6 arm. The Steiner told Vascular News: “In this series the system patients will be followed for up to five years, and patient IN.PACT drug-coated balloon was used later on, Two cases have been successfully completed us- risk score(s) will be developed as a clinical predictor of therefore fewer patients with 18-month follow-up ing the AorFit (Aortica) system to support simpli- outcomes to provide guidance for interventions. were available for analysis. This was due to logistic fied fenestrated endovascular aneurysm repair (FE- LIBERTY 360°, the first peripheral arterial disease reasons of drug-coated balloon availability at our VAR). The surgeries were performed by Benjamin study to specifically include these disease states, will centre, not clinical reasons. We cannot exclude Starnes, chief of Vascular Surgery, University of evaluate numerous parameters including procedural that this might have an impact on our results.”

March 2016 Companies 57

subcutaneous vascular access system that is computational fluid dynamics and finite intended for use in maintaining long-term element analysis (FEA) to support this work. vascular access for chronic haemodialysis Vascular Flow Technologies’ SLF Industry News patients who have exhausted peripheral technology is a unique, intellectual property- venous access sites suitable for fistulas or protected design which is intended to grafts. The product has received 510(k) eliminate the turbulent blood flow seen in Endologix and TriVascular and former TriVascular stockholders own clearance from the US Food and Drug diseased vessels and standard prosthetic complete merger approximately 16%. TriVascular shares have Administration, and has CE marking. vascular grafts. By reintroducing the Endologix has successfully completed now ceased trading on the NASDAQ Global Merit purchased the HeRO graft assets for normal pattern of blood flow through the the previously announced merger with Select Market. Effective upon completion US$18.5 million and financed the deal under vessel, graft failure and complications for TriVascular Technologies. John McDermott, of the merger, Christopher G Chavez, existing banking agreements. the patient are significantly reduced. The chairman and chief executive officer of the former president and chief executive Canaccord Genuity provided technology is built on an extensive base of Endologix, said, “The completion of the officer of TriVascular, was appointed to the financial advice to Merit in connection evidence produced using computational merger with TriVascular is a major milestone Endologix board of directors. with this transaction. fluid dynamics (models of fluid flow created for both companies that further enhances with numerical analysis) and FEA (virtual our technology platforms and positions Maquet to distribute Biotronik Vascular Flow Technologies modelling to problem solve potential stresses the combined business for robust growth endovascular devices in the closes £10m financing round on vessel walls). A number of clinical with an accelerated path to profitability. USA Vascular Flow Technologies has closed evidence programs are also underway in the Both teams have been working diligently Maquet Medical Systems USA has begun a £10m financing round. The funds will USA and Europe, establishing long-term preparing for the merger and we believe a partnership with Biotronik. Maquet, a support the company’s realignment of clinical and economic outcomes. that we are well positioned to execute on Getinge Group company, is to distribute business strategy to focus on research and Bill Allan, chief executive officer of our integration and commercial plans. Biotronik’s peripheral vascular devise in development, as well as strategic joint Vascular Flow Technologies comments, In the near-term, our focus is on training the USA. development and out-licensing agreements “The £10m secured in this investment the combined sales and clinical teams, The agreement will see Maquet distribute with leading industry partners. round will make a significant impact on introducing our comprehensive product a number of products used to treat periperhal The equity round consisted of two the transition, and allow us to continue to portfolio to physicians and successfully artery disease. These products include the concurrent transactions; a £7 million loan work with the key players in the sector to capturing identified synergies.” Astron iliac self-expanding stent—which note restructuring into the Series A Ordinary apply SLF technology to address unmet Under the terms of the merger agreement, was recently granted FDA approval for the Preference shares and a £3 million Series clinical needs in vascular and endovascular each outstanding share of TriVascular treatment of iliac artery disease—the Passeo B capital increase. The Series B financing markets.” common stock (other than shares of percutaneous transluminal angioplasty round was led by an undisclosed family The new business model should see an TriVascular common stock and other than balloon family, and the Fortress family of office and supported by institutional and increase in collaborative work, which will certain other shares of TriVascular stock reinforced sheaths. This distribution will individual angel investors. allow Vascular Flow Technologies to further owned or held by Endologix, TriVascular or start from the first quarter of 2016. Vascular Flow Technologies will use accelerate its research and development their affiliates which were cancelled) was the £10m towards the development of the projects. Current collaborations include exchanged for 0.631 shares of Endologix Merit acquires HeRO graft company as a technology transfer business. ongoing work in stents and haemodialysis common stock and US$0.34 of cash. device from CryoLife The company will be refocusing on the access catheters. Former Endologix stockholders own Merit Medical Systems has purchased core competency of applying its proprietary Catalysis Capital Partners acted as the approximately 84% of the shares of the the HeRO graft device and related assets Spiral laminar flow (SLF) technology to exclusive financial advisor to Vascular Flow combined company on a fully diluted basis from CryoLife. The HeRO graft is a fully vascular and endovascular devices, using Technologies on the financing. 58 Events March 2016

Calendar of events team

Editor-in-chief: 7–9 April 11–13 May 8–11 June 28–30 September Roger Greenhalgh NCVH Latin America EWMA 2016—European Vascular Annual Meeting European Society for Vascular Monterrey, Mexico Wound Management National Harbor, USA Surgery Annual Meeting Publisher: Roger Greenhalgh W ncvh.org Association Gaylord National Resort Copenhagen, Denmark Bremen, Germany vascularannualmeeting.org esvs.org W W Head of Publishing: 13–17 April Messe Bremen Marcio Brito L’Union Internationale de W ewma2016.org 30 June–1 July 5–8 October Phlébologie Rome 2016 BSET Annual Meeting Dreiländertagung Senior Editor: Chapter Meeting 17–20 May Walton Hall, Warwick, Bern, Switzerland Marcio Brito Rome, Italy EuroPCR Warwickshire, UK Kursaal Bern [email protected] E andreina.mancini@ Paris, France W bset.co.uk W www.dreilaendertagung2016. Editor: gccongressi.it Palais des Congrès ch David Brennan W uip2016.com W europcr.com 7–9 July [email protected] European Venous Forum 13–15 October 14–16 April 20–21 May London, UK 20th Endovascology Editorial contribution: 7th Annual Venous Critical Issues in Aortic The Royal Society of Medicine Shanghai, China Angela Gonzalez Symposium New York Endografting W europeanvenousforum.org W www.endovascology.org Dawn Powell New York, USA Lille, France Katherine Hignett New York Hilton Midtown Barrière Hotel 18–20 August 17–18 October Design: W venous-symposium.com E [email protected] 9th Conference of the Aortic Live Symposium David Reekie German-Japanese Society of Essen, Germany 21–24 April 25 May Vascular Surgery E [email protected] Layout: 65th ESCVS—International Pacific Northwest Hiroshima, Japan W www.cong-o.de Naomi Amorra Congress of the European Endovascular Conference Hiroshima Prince Hotel Society for CardioVascular Seattle, USA W www.ec-knt.jp/9th-gjsvs 29 October–2 November Advertising: Lauren Isola and Endovascular Surgery Convention Place TCT—Transcatheter [email protected] Belgrade, Serbia W pnec-seattle.org 15–17 September Cardiovascular Therapeutics W escvs2016.org IMAD—5th International Washington, DC, USA Subscriptions: 26–28 May Meeting on Aortic Diseases Walter E Washington Convention Sue Couch 26–29 April LIVE 2016—Leading Liège, Belgium Center [email protected] Charing Cross Symposium— Innovative Vascular Education W chuliege-imaa.be www.tctconference.com Vascular & Endovascular Ioannina, Greece Please contact the Challenges Update Du Lac Hotel and Congress 10–14 September 30 November–2 December Vascular News team with news or advertising London, UK Center CIRSE Vascular Society Annual queries Olympia Grand W conferre.gr/congress/live2016 Barcelona, Spain Scientific Meeting Tel: +44 (0)20 7736 8788 E [email protected] W cirse.org Manchester, UK W cxsymposium.com 1–3 June W www.vascularsociety.org.uk Published by: New Cardiovascular Horizons 15–17 September BIBA Medical, 28–30 April New Orleans, USA IMAD—5th International 2–3 December 526 Fulham Road, 2016 International Vein The Roosevelt Hotel Meeting on Aortic Diseases MAC—6th Munich Vascular Fulham, London, SW6 5NR, UK Congress W ncvh.org/2016 Liège, Belgium Conference Tel: +44 (0) 20 7736 8788 Miami, USA W www.chuliege-imaa.be W www.mac-conference.com W ivcmiami.com 2–3 June Printed by: I-MEET 2016— 18–22 September 15–17 December Buxton Press 8–10 May Multidisciplinary European VIVA16 7th International Congress 2nd Annual Congress of Endovascular Therapy Las Vegas, USA Aortic and Peripheral Surgery Reprint requests and all the European Society for Nice, France Wynn Las Vegas “How to do it” correspondence regarding Vascular Medicine W meetcongress.com W www.vivaphysicians.org Milan, Italy the newspaper should be addressed to the editor at Rome, Italy Ospedale San Raffaele, Univer- the above address. E [email protected] sita Vita-Salute San Raffaele © BIBA Medical Ltd, 2016 W vascular-medicine.org W www.aorticsurgery.it All rights reserved. Write to us! If you have comments on this issue or suggestions for upcoming editions write to [email protected] or [email protected]

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