Vascular News – CX Special Edition 2021

Charing Cross Special Edition | April 2021

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Andrew Holden What to expect 09/03/2021 09:35:59 from the Peripheral session at CX 2021

No controversy CX 2021: The Hurting Leg

A Year in Profiles Hence Verhagen, Chris Imray, Roberto Chiesa, Julie Ann Freischlag

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CX 2021 scrutinises hottest vascular Controversies The CX 2021 Digital Edition will include 13 Podium 1st presentations and more than 20 edited cases, illustrating data presented during the programme. There will also be 19 high-quality debates and two roundtable sessions. A total of 50% of symposium time will be dedicated to audience participation and discussion.

This means 16 hours of presentations, matched by 16 hours of live discussion.

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his year, CX will take the form of a broadcast-quality, digital-only event with international reach— the CX 2021 Digital Edition. From 19–22 April, world-leading expert speakers and Faculty will interact with a live, online audience to address key controversies that really matter to the global vascular community. The occasion marks the start of a new three-year cycle of raising vascular and endovascular Controversies so that a world-class Faculty Challenges the available evidence in order to reach a Consensus after discussion with an expert audience. Two livestreams and on-demand channels will showcase the hottest topics and latest data in the management of vascular disease. CX has

applied for CME accreditation, which is now available for both live and ondemand content.

Debates and roundtables focus on key vascular controversies

This year CX will feature a series of debates and roundtables, all designed to tackle key vascular controversies. In the Abdominal Aortic Controversies session, one of the debates will consider whether emergency EVAR is the standard of care for ruptured AAA; in the Paclitaxel Arterial Proximal Controversies session, experts will consider whether it is time to change the agency recommendations

regarding paclitaxel use in peripheral interventions; in the Thoracic Aortic session, endovascular repair of thoracoabdominal aortic aneurysms (TAAAs) in patients with connective tissue disorders will be in the spotlight; and in the Deep Venous & Lymphatic session, specialists will deliberate the role of preprocedure anatomy in predicting outcomes after deep venous stenting.

Five debates will feature in the Acute Stroke session, including one on the controversial topic of carotid artery stenting in asymptomatic patients.

Podium 1st presentations shed light on new data

The theme for CX 2021 is Controversies and the event will feature 13 highlyanticipated Podium 1st presentations from leading experts, including Xavier Berard (France), Charles McCollum (UK), Andrew Holden (New Zealand), Michel Reijnen (The Netherlands), Mitchell Silver (USA), and Philip Puckridge (Australia).

Presidents take the rostrum: A hallmark of CX CX is delighted to welcome expert speakers such as Hence Verhagen (European Society for Vascular Surgery [ESVS] president), Michael Jenkins (Vascular Society of Great Britain and Ireland [VSGBI] president), and Markus Steinbauer (German Society

of Vascular Surgery [DGG] president), who will all be taking part in the exciting Controversies programme.

Wide range of edited cases illustrate latest data

The CX 2021 Digital Edition will include more than 20 edited cases from leading experts, illustrating some of the new data that will be presented as part of the programme. These edited cases will feature world-renowned specialists such as Stéphan Haulon (France), Dittmar Böckler (France), Andrea Kahlberg (Italy), Koen Deloose (Belgium), and Gerry O’Sullivan (Ireland).

New programme streams broaden educational reach

This year, CX will broaden even further its coverage of vascular disease management. As well as sessions on Abdominal Aortic, Peripheral Arterial Proximal, Thoracic Aortic, Venous & Lymphatic, Vascular Access, and Acute Stroke Controversies, this year will see the addition of two further dedicated programme streams: Vascular Trauma and ‘The Hurting Leg: Urgency Mandatory—No controversy’.

Register for CX 2021 now at www.cxsymposium.com to join the global vascular discussion.

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Charing Cross Special Edition | April 2021

CX 2021

Aortic Abdominal Controversies

Abdominal Aortic session highlights: Debates and new data

Lively debates will tackle the biggest controversies 14:00–19:30 Monday 19 April Livestream 1

Colin Bicknell (Imperial College London, London, UK) and president of the Vascular Society of Great Britain and Ireland (VSGBI) Michael Jenkins (St Mary’s Hospital, Imperial College Healthcare NHS Foundation Trust, London, UK) will go toe-to-toe in a hotly anticipated debate titled ‘Standard EVAR [endovascular aneurysm repair] can be used in most challenging necks’. In addition, Janet Powell (Imperial College London, London, UK) and Marc Schermerhorn (Beth Israel Deaconess Medical Center, Boston, USA) will debate whether or not device registries and randomised controlled trials underreport patient quality of life and return to normal activities.

In the final debate of the session, ‘Emergency EVAR is the standard of care for ruptured AAA’, Hans-Henning Eckstein (Technical University of Munich, Munich, Germany) will put forward the reasons why he is in favour of the motion, while Clement Darling (Albany Medical Center Hospital, New York, USA) will explain why he is not. The session will also showcase juxtarenal advances. One of the upcoming highlights of this session will be a presentation by Caroline Caradu (Groupe Hospitalier Pellegrin, Bordeaux, France) who will be discussing sac regression after fenestrated EVAR (FEVAR). Another controversial topic will be presented by Kevin Mani (Uppsala University, Uppsala, Sweden), who will be looking at the role of pre-emptive coiling to avoid type II endoleak after EVAR. There will also be four edited cases which will illustrate the latest advances and data: ‘Abdominal aortic aneurysm treated with a low-profile stent graft and using CO2 angiography’ (Mauro Gargiulo, University of Bologna, Bologna, Italy), ‘Expanding EVAR while preserving hypogastric flow’ (Jan Heyligers, Elisabeth-TweeSteden Hospital, Tilburg, The Netherlands), and ‘Open conversion after EVAR: Tips and tricks to succeed in such a difficult procedure’ (Enrico Rinaldi, San Raffaele Scientific Institute, Milan, Italy), and ‘The practical use of endoanchors in the treatment of a hostile neck (ESAR; Giovanni Pratesi, University of Rome “Tor Vergata”, Rome, Italy).

Abdominal Aortic Podium 1sts • Systematic review and meta-analysis on accessory renal arteries coverage in EVAR and complex endovascular repair (chEVAR, F/BEVAR) •K onstantinos Spanos (Larissa, Greece) • BUTTERFLY study: Long-term assessment of bridging stent integrity and flare geometry after FEVAR •C aroline Caradu (Bordeaux, France) • In situ reconstruction of native or (stent) graft aortic infections with antimicrobial grafts • Xavier Berard (Bordeaux, France)

Programme highlight:

Experts to debate whether standard EVAR can be used in most challenging necks For the motion: Colin Bicknell (London, UK) In recent years, we have seen a significant increase in technology associated with improvements in outcome. Graft design and techniques have evolved to tackle the short-term issue of sealing and long-term issues of migration and type I endoleak. I will argue that EVAR is appropriate, our patients are not fit, and extending long-term solutions are not always needed.

Lastly, with COVID-19 around us, there is a reason to treat whoever we can under local anaesthetic with a shorter hospital stay.

Against the motion: Michael Jenkins (London, UK) We have gained quite a lot of evidence over the last five years to show that standard EVAR does not work in most challenging necks. I think worldwide we have adopted the most minimally invasive technology and that is what patients want and that is what we want. However, that treatment has to work for them, and if that treatment fails, it is not a good treatment for them. I truly believe that one day the technology will be there to treat the most difficult aneurysm morphologies, but at the moment, that is just not the case.

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Charing Cross Special Edition | April 2021

CX 2021

Peripheral Arterial Controversies

14:00–19:30 Tuesday 20 April Livestream 1

Paclitaxel controversy takes centre stage in Peripheral session

This year’s Peripheral Arterial programme will open with a session on the evolving debate surrounding paclitaxelcoated devices. CX Executive Board members Andrew Holden (Auckland City Hospital, Auckland, New Zealand) and Gunnar Tepe (Klinikum Rosenheim, Rosenheim, Germany) will moderate this vital session. Long-term data, notably five-year mortality in the REAL-PTX study, will be presented by Sabine Steiner (University of Leipzig, Leipzig, Germany), and Märten Falkenberg (Gothenburg University, Gothenburg, Sweden) will give an update on the SWEDEPAD trial.

The session will also consider the role of limus in this arena, with Edward Choke (Sengkang General Hospital, Singapore) to argue that this paclitaxel alternative is the better drug for prevention of restenosis in peripheral interventions.

A key feature of the session will be the role of regulatory agencies. Sara Royce (US Food and Drug Administration [FDA], Silver Spring, USA) will cover clinical evaluation and regulatory approaches to next-generation drug-coated devices for peripheral arterial disease (PAD) and CX Executive Board member Thomas Zeller (University Heart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany) will argue that it is time to change the agency recommendations regarding paclitaxel use in peripheral interventions.

As always, the CX Peripheral Arterial programme will feature a series of Podium 1st presentations, including new data from ZILVERPASS, IN.PACT Global, and the ILLUMENATE FLEX study – randomised controlled Jean Panneton trials. This session will (Norfolk, USA) will be chaired by Zeller present three-year and Robert Hinchliffe follow-up data of (University of Bristol, patients with iliac Bristol, UK). occlusive disease The Peripheral treated with a Arterial programme balloon-expandable will cover calcification endoprosthesis controversies, in a FLEX study session moderated by Zeller and Tepe. The session will feature an edited case by Richard O’Neill (Nottingham University Hospitals NHS Trust, Nottingham, UK) that will address the question ‘When balloons will not pass is atherectomy the answer?’

Regarding data, this session will also feature 12-month REALITY results on vessel preparation for long, calcified femoropopliteal lesions with directional atherectomy and a drug-coated balloon (DCB) by Krishna Rocha-Singh (Prairie Heart Institute, Springfield, USA) and a presentation

by Michael Lichtenberg (Karolinen Hospital, Arnsberg, Germany) reviewing evidence and detailing learnings from the TOBA trials.

Peripheral Arterial Proximal Podium 1sts • Five-year meta-analysis including mortality update with FDA-approved RCTs of paclitaxel devices •A ndrew Holden (Auckland, New Zealand) • IVUS vs. angiography-guided femoropopliteal revascularisation: Twelve-month results from a randomised controlled trial •P hilip Puckridge (Marion, Australia) • Comparison of swirling flow stent and drug-eluting device outcomes • Peter Gaines (Sheffield, UK) • ZILVERPASS 36-month data update •M ichel Bosiers (Muenster, Germany) • Five-year outcomes with DCB alone vs.

DCB plus stenting from the IN.PACT Global study •G ary Ansel (Columbus, USA) • Five-year results from a patient-level meta-analysis of the ILLUMENATE RCTs • William Gray (Wynnewood, USA)

Reconstruction: Trial updates, edited cases, and a CX Debate Zeller and Holden will moderate a session on reconstruction controversies, which will include a CX Debate, trial updates, and two edited cases.

Jean Panneton (Eastern Virginia Medical School, Norfolk, USA) will present on the FLEX study, outlining three-year follow-up of patients with iliac occlusive disease treated with a balloonexpandable endoprosthesis, and Osamu Iida (Kansai Rosai Hospital, Amagasaki, Japan) will detail one-year results of the VANQUISH trial of a heparin-bonded stent graft for femoropopliteal disease.

Rutger Lelij (Amsterdam UMC, Amsterdam, The Netherlands) will give the first of two edited cases, outlining a complex occlusive iliac recanalisation. Also to show an edited case will be Koen Deloose (AZ Sint-Blasius Hospital, Dendermonde, Belgium), who will talk through a long superficial femoral artery (SFA) bypass treatment for in-stent restenosis.

In the CX Debate, Rebeca Reachi-Lugo (Hospital Beneficencia Espanola, San Luis Potosi, Mexico) will argue for the motion ‘For symptomatic origin of profunda femoris artery lesions, endovascular reconstruction is indicated’.

Hinchliffe will argue against the motion.

Andrew Holden 14:00–19:30 Tuesday 20 April Livestream 1 What can delegates expect from this year’s meeting in terms of understanding the paclitaxel controversy?

This year, we are focusing on controversies. While 2020 was clearly the year of the pandemic, those of us who are endovascular specialists remember 2019 as being the year of the paclitaxel controversy, provoked by a meta-analysis that was published just a month or so before the start of 2019 [in the Journal of the American Heart Association (JAHA) by Konstantinos Katsanos (University of Patras, Patras, Greece) et al]. While it is very import to take reports on safety very seriously, many of us were concerned for patients who, subsequent to this meta-analysis, were not receiving some of the profound benefits of paclitaxel-based anti-restenotic therapies in the lower limb arteries, drug-coated balloons and drug-eluting stents. Clearly, these paclitaxel-eluting devices have shown superior patency with lower reintervention rates compared to standard treatment, sustained for many years. Because of that controversy, the use of these devices significantly decreased and there has been real interest in trying to assess if the paclitaxel safety issue was real or due to some other factors, such as trial design, trial patient numbers, and length of follow-up. With that in mind, there has been a huge effort to re-evaluate the data in terms of randomised controlled trials and real-world data, and I am delighted to say that a new meta-analysis with updated five-year data sheds new light on the paclitaxel mortality issue.

If the paclitaxel mortality issue proves to be incorrect, we need to think about how we integrate paclitaxel into our current practice, and how the regulators in particular deal with this issue. This is important for the global vascular community, because paclitaxel-based products are such a vital component of offering state-of-the-art care for our lower-limb arterial occlusive patients.

“If the paclitaxel mortality issue proves to be incorrect, we need to think about how to integrate paclitaxel into our current practice.”

Charing Cross Special Edition | April 2021

CX 2021

The Hurting Leg Controversies

No controversy: New programme stream to urgently discuss The Hurting Leg 14:00–19:30 Thursday 22 April Livestream 1

CX 2021 will see the addition of a new programme stream—The Hurting Leg. Experts will outline and discuss the need for rapid diagnosis and treatment of the acute ‘hurting leg’.

The programme will cover controversies around intervention considerations. Michael Lichtenberg (Karolinen Hospital, Arnsberg, Germany) will present on the multicentre PRESTIGE trial analysing intravascular ultrasound (IVUS)-guided atherectomy below the knee in patients with critical limb ischaemia. In addition, Markus Steinbauer (Barmherzige Brüder Regensburg, Regensburg, Germany), current president of the German Society of Vascular Surgery (DGG), will give a presentation on the impact of chronic kidney disease on the outcomes of infrapopliteal venous and heparin-bonded expanded polytetrafluoroethylene bypass surgeries.

Novel technology controversies will also feature on this new programme.

A CX Debate will consider whether paclitaxel-coated balloons should be the treatment of choice for preventing restenosis in below-the-knee interventions, with Francesco Liistro (Azienda Usl Toscana Sud Est, Arezzo, Italy) arguing for the motion and Robert Hinchliffe (University of Bristol, Bristol, UK) arguing against.

William Jeffcoate (Nottingham University Hospitals NHS Trust Nottingham, UK) will speak on the impact of socio-economic and clinical variables on the incidence of major amputation in people with diabetic foot ulcers, a presentation he outlines in the Q&A opposite.

This session will also include presentations on amputation-free survival and limb salvage with deep venous arterialisation (Peter Schneider, University of California San Francisco, San Francisco, USA) and results of the PRELUDEBTK study into a novel serration angioplasty balloon for below-the-knee arteries (Andrew Holden, Auckland City Hospital, Auckland, New Zealand).

Podium 1st presentation to showcase long-term data from IN.PACT Global study

Another key feature of the programme will be controversies surrounding the hurting leg. This will include a Podium 1st presentation on five-year outcomes of DCB treatment in critical limb ischaemia from the IN.PACT Global study

by Michel Reijnen (Rijnstate Hospital, Arnhem, The Netherlands). This section will also showcase research on catheter-directed thrombolysis versus aspiration thrombectomy in the management of acute limb ischaemia, with Maria Antonella Ruffino (Azienda Ospedaliera Universitaria Città della Salute e della Scienza, Turin, Italy) outlining lessons learned from a multicentre retrospective physician-initiated registry. In addition, Michael Dake (University of Arizona Health Sciences, Tucson, USA) will showcase a prediction model for freedom from target lesion revascularisation (TLR) from a multi-study analysis of long-term results with a drug-eluting stent, and Yan Gouëffic (Groupement Hôpitalier Paris St Joseph, Paris, France) will outline a budget impact analysis of heparin-bonded expanded polytetrafluoroethylene (ePTFE) grafts against standard ePTFE grafts for below-the-knee bypass in patients with critical limb ischaemia.

The session will also consider the hurting leg in the context of COVID-19, with presentations focusing on the effect of the virus on amputation rates across a 29-hospital system, reducing time to treatment for patients with critical limb ischaemia during the pandemic, and a clinical evaluation of chronic limb-threatening ischaemia patients and other frail patients in the era of COVID-19.

Programme highlight:

Roundtable to address unacceptably high major amputation rate CX Executive Board members Thomas Zeller (University Heart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany) and Andrew Holden will moderate a rountdtable discussion that will highlight the importance of a multidisciplinary approach to the hurting leg.

Three experts will take part: Michael Edmonds (King’s College Hospital NHS Foundation Trust, London, UK; CX Executive Board), who will put forward the diabetologist’s perspective; Robert Hinchliffe, who will give the vascular surgeon’s perspective; and Gunnar Tepe (Klinikum Rosenheim, Rosenheim, Germany; CX Executive Board), who will contribute the interventional radiologist’s perspective.

Michael Edmonds

Robert Hinchliffe

Gunnar Tepe

William Jeffcoate 14:00–19:30 Thursday 22 April Livestream 1 Could you briefly summarise the highlights of your planned presentation for CX 2021?

We are trying to look at the reasons why there is such an enormous regional variation in the incidence of amputation, certainly throughout England and Wales, but also in other countries, such as the USA. To do that, we have used the data from the National Diabetes Foot Care Audit of England and Wales—data on slightly more than 26,000 people with diabetes and foot ulcers. We have looked at the different variables that we know are associated with increased risk of major amputation, such as peripheral arterial disease, age, renal function, etc. and have tried to determine in this very large population how much the variation in the incidence of major amputation across England and Wales can be attributed to population differences.

Why is your topic a particularly important one for the global vascular community?

This question is important for the global vascular community because the problem exists globally. There are obviously some parts of the world where there are known factors, such as ethnic differences regarding susceptibility to peripheral arterial disease (PAD), and there are other parts of the world where poverty or social deprivation of one form or another is dominant, and that contributes. However, it is important for us to look also at the structure of the provision of care in our own countries and to see how much that might also be contributing to the variation that exists.

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In your view, what more needs to be done to reduce the levels of major amputation in those with diabetic foot ulcers?

We need to identify the extent of variation in incidence of major amputation that exists in our own country. We then need to determine the extent to which this variation might be explained by differences in the structure and accessibility of clinical care.

“ This question is important for the global vascular community because the problem exists globally.

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The Hurting Leg Controversies

DIGITAL EDITION WWW.CXSYMPOSIUM.COM CX 2021 will be streamed live daily with audience participation, discussion and polling

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Charing Cross Special Edition | April 2021

10 CX 2021

Vascular Access Controversies

CX 2021 Vascular Access programme to highlight creation and maintenance controversies

14:00–19:30 Tuesday 20 April Livestream 2

This year’s CX Vascular Access programme will focus on a range of creation and maintenance controversies, as well as highlighting both new advances in the field and first-time data on key technologies. The programme will feature a Podium 1st, two edited cases, and a series of presentations all aimed at progressing the field of vascular access. All sessions will be moderated by CX Executive Board members Nicholas Inston (Queen Elizabeth Hospital Birmingham, Birmingham, UK) and Domenico Valenti (King’s College London, London, UK).

The Vascular Access Controversies programme will take place on Tuesday 20 April and will open with a session on new advances in vascular access creation. This session will focus on percutaneous fistula creation, with Panagiotis Kitrou (University of Patras, Patras, Greece) first giving a data update on the new WAVE GLOBAL and CONNECT AV trials with an endovascular arteriovenous fistula (endoAVF) system. Among other presentations, viewers will hear the results of a multicentre European experience with an anastomotic external support device for AVFs. This first session will also feature two edited cases: in the first, Ounali Jaffer (Barts Health, Walton on Thames, UK) will demonstrate the use of an endoAVF system for endovascular AVF creation; in the second, Robert Shahverdyan (Asklepios Clinic Barmbek, Hamburg, Germany) will show a case involving percutaneous AV fistula creation for haemodialysis access.

The programme will then cover controversies regarding access maintenance. This will open with Andrew Holden (Auckland City Hospital, Auckland, New Zealand) giving a Podium 1st presentation on the IN.PACT AV Access

trial. Holden is set to detail efficacy and safety at 18 and 24 months. Other presentations in this session will cover economic outcomes with drug-coated balloons in AV access, updates from the AVeNEW and AVeVA trials, and why optimal surveillance is critical to long-term AV graft function. Viewers will also hear the outcomes of a prospective first-in-man study with an endovascular stent graft for the treatment of access circuit flow stenosis.

In the final section of the programme, Peter Thomson (Queen Elizabeth University Hospital, Glasgow, UK) will discuss how to optimise AV access care, highlighting a patient selection tool to identify high-risk failure in mature patients. Other topics will include ultrasound-guided percutaneous transluminal angioplasty of AVFs, avoiding central venous catheters (CVCs), strategies in the COVID-19 era and beyond, an update on bioengineered grafts for vascular access, and the benefits of a new-generation dialysis machine. In addition, THE MOTION participants will hear outcomes of a pilot study Paul Gibbs using a scoring balloon to (Portsmouth, UK) restore AV access in 50 patients.

“A topic of controversy that is poorly understood is that of high flow fistulas,” Nicholas Inston tells Vascular News. “This is a really interesting area and one I think that will create a lot of debate,” he comments.

As well as defining a high flow fistula, Inston details that the session will address a number of key questions: “Does a high-flow fistula have cardiovascular risks? Does it have risks in terms of increasing interventions, increasing problems?

Why do we need a fistula that runs at high flow when actually you only need a fistula that runs about a litre a minute?”

In keeping with the controversial nature of this topic, this section of the Vascular Access programme will feature a CX Debate, entitled ‘We should reduce flow in high fistulas (>1,500ml)’. Paul Gibbs (Queen Alexandra Hospital, Portsmouth,

The main controversy that we want to discuss is what to do about the highflow fistula.”

Could you outline the Vascular Access highlights from the programme you have put together for CX 2021?

The CX 2021 Vascular Access programme as usual covers a lot of ground, but there are some real highlights this year. We are going to start the day by talking about device-created fistulas, and of course we now have the options of surgically-created or devicecreated fistulas. Where we use these, how we use these, and what are the expected outcomes will be discussed. We are also going to delve into the field of highflow fistulas. This is an area that has not really been discussed very much in the past and I think this will be the first Masterclass where highflow fistulas will be in the spotlight. New devices and new evidence is emerging, such as which balloons are best in vascular access, which stents, and where and when they should be used. We aim to explore all of this.

THE MOTION

‘We should reduce flow in high flow fistulas (>1,500ml)’ FOR

Programme highlight:

Vascular Access programme targets impact of high-flow arteriovenous fistulas

Nicholas Inston 14:00–19:30 Tuesday 20 April Livestream 2

UK) will argue for the motion, while Surendra Shenoy (Washington University School of Medicine, St Louis, USA) will argue against the motion.

Considering why this controversy should matter to the global vascular community, Inston remarks: “We do not really know how to deal with highflow fistulas.” He outlines a variation in practice across the world as being one of the key reasons why this topic is a top priority for discussion at CX 2021: “International practice differences exist in cannulation and dialysis provision with some approaches aiming for fistulas to suit the logistics of dialysis rather than best long-term outcomes for the fistula and the patient. I think this session will raise many questions about vascular access in general and stimulate some interesting discussion.”

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Surendra Shenoy

Why should physicians attend the CX 2021 (St Louis, USA) Vascular Access sessions and what do you think they might learn?

I think it is imperative that people keep up their education during this pandemic. The way that we work and the way that patient care is delivered has been hugely disrupted, and there are definitely things that we can learn from the last year. With these changes in practice, it is important to find out what has actually happened to those patients that have not been able to have treatment, or their treatment has been altered. We need to make sure that we learn lessons from each other about new and different approaches to vascular access care.

“ I think it is imperative that people keep up their education during this pandemic.”

Charing Cross Special Edition | April 2021

12 CX 2021

Thoracic Aortic Controversies

CX 2021 to address key controversies in diagnosis and treatment of thoracic aortic disease

14:00–19:30 Wednesday 21 April Livestream 1

The Thoracic Aortic session at CX 2021 will first address the controversy of diagnosis for intervention and device design, with Jörg Tessarek (Bonifatius Hospital Lingen, Lingen, Germany) giving a presentation on ‘IVUS [intravascular ultrasound] in thoracic and abdominal aortic repair: A practice approach to increase precision and reduce radiation’. Also in this session, Timothy Resch (Rigshospitalet, Copenhagen, Denmark) will aim to answer the question ‘Device design of patient anatomy—what is first?’

Focusing on arch controversies, Michael Dake (University of Arizona, Tucson, USA) will present mid-term results from thoracic branch endoprosthesis feasibility trials. In addition, Martin Czerny (Albert Ludwigs University, Freiburg, Germany) will speak about the learning curve associated with new technologies.

Thoracoabdominal aneurysm controversies will also be addressed. CX Executive Board members Stéphan Haulon (Hôpital Marie Lannelongue, GHPSJ, Paris, France) and Roberto Chiesa (IRCCS San Raffaele Scientific Institute, Milan, Italy) will debate the motion ‘The majority of thoracoabdominal aortic aneurysms (TAAAs) in patients with connective tissue disorders can be approached with endovascular repair’. present arguments for and against.

Also in this section, CX Executive Board member Gustavo Oderich (University of Texas Health Science Center, Houston, USA) will discuss TAAA repair without spinal drains and Bijan Modarai (Guy’s and St Thomas’ NHS Foundation Trust, London, UK) will give a presentation titled ‘Radiation exposure: A valuable quality metric for endovascular aortic repair’. Finally, Mark Farber (The University of North Carolina, Chapel Hill, USA) will present early clinical results with an off-the-shelf thoracoabdominal branched device.

In a section on dissecting aneurysm controversies, presentations will highlight the causes of distal stent graftinduced new entry in thoracic endovascular aortic repair (TEVAR) for dissecting aneurysms, and the crucial nature of timing in type B aortic dissection.

Q&A

Descending thoracic aneurysm controversies will also be in focus. This section will include results from an independent European multicentre study on a new generation thoracic device and what these results tell us about contemporary TEVAR treatment, as well as a presentation on the creation of artificial landing zones in the thoracic and abdominal aorta.

Programme highlight:

Five edited cases to show cutting-edge techniques The Thoracic Aortic Controversies programme at CX 2021 will feature five edited cases. Addressing arch controversies, Stéphan Haulon will showcase a fully percutaneous arch branch repair and Piotr Szopinski (Institute of Haematology and Transfusion Medicine, Warsaw, Poland) will demonstrate a triple branch zone 0 TEVAR with no debranching and no extra-anatomic bypass.

Stéphan Haulon will also present an edited case in the dissecting aneurysm controversies section of the programme, involving chronic dissection treated with a combined fenestrated/ branched custom-made low-profile device with preloaded catheters. The final two edited cases of the session, on the topic of descending thoracic aneurysm controversies, will cover TEVAR with staged deployment in challenging anatomies (Dittmar Böckler, University Hospital Heidelberg, Heidelberg, Germany) and the use of an antimicrobial graft for aortoesophageal fistula (Andrea Kahlberg, IRCCS San Raffaele Scientific Institute, Milan, Italy).

Gustavo Oderich 14:00–19:30 Wednesday 21 April Livestream 1 Could you briefly summarise the highlights of your planned presentation for CX 2021?

I will have the chance to share some thoughts on thoracoabdominal endovascular repair without drains.

This is considered controversial because we have used drains for many years but we have learned that they are not without problems—we all know about the complications of spinal haematoma and intracranial bleeding. I will be sharing whether we have achieved the expected results from a very large dataset without using drains. This is a hot topic and I look forward to having the chance to discuss it at CX. Why should physicians attend the CX 2021 Thoracic Aortic session?

Endovascular therapy has been widely accepted as the first-line treatment for thoracic disease and we are now in an era where we are going to be seeing more and more complex procedures in the aortic arch and thoracoabdominal aorta.

It will be good to learn what are the new devices that are coming along and to get the chance to hear from expert speakers on pressing issues and what we are doing to improve previous limitations on these repairs.

“ We are going to be seeing more and more complex procedures in the aortic arch and thoracoabdominal aorta.

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Venous & Lymphatic Controversies

CX 2021 13

Dedicated sessions to address key issues in superficial and deep venous disease

Podium 1st presentations to highlight new data in superficial venous disease management 14:00–19:30 Monday 19 April Livestream 2

The Superficial Venous & Lymphatic Superficial Controversies programme at CX 2021 will open with a discussion on key issues in superficial venous disease. In a CX Debate, Steve Elias (Englewood Hospital, Englewood, USA) and CX Executive Board member Armando Mansilha (University of Porto, Porto, Portugal) will put forward their views on whether or not ‘Open surgery should be obsolete in 2021 for the treatment of superficial truncal reflux’. Elias will argue in favour of the motion and Mansilha against.

There will be two Podium 1st presentations from Charles McCollum (University of Manchester, Manchester, UK) in the section on pelvic venous controversies. The first will be ‘Coil/foam occlusion for pelvic pain incompetence: Preliminary results from the NIHR randomised controlled trial’, followed by ‘Case-control study on the frequency of both pelvic vein incompetence and pelvic varices in women with chronic pelvic pain’. The lymphatic controversies section will feature a range of presentations, including ‘Understanding the concept of phlebolymphoedema’ (Raghu Kolluri, OhioHealth Heart and Vascular, Columbus, USA). Concluding the session, Erin Murphy (Sanger Heart and Vascular Institute, Charlotte, USA), Rebeca Reachi-Lugo (Hospital Beneficencia Espanola, San Luis Potosi, Mexico), and Charles McCollum will take part in an exciting roundtable where they will discuss ‘Causes of severely swollen lower limb’.

L to R: Erin Murphy, Rebeca Reachi-Lugo and Charles McCollum

Deep venous session to feature debates on stenting and wound controversies 14:00–19:30 Wednesday 21 April Livestream 2

The CX 2021 Deep Venous & Lymphatic programme will feature a CX Debate on the motion ‘Preprocedure anatomy is enough to predict outcomes after deep venous stenting’, with Houman Jalaie (University Hospital RWTH, Aachen, Germany) presenting arguments for and William Marston (University of North Carolina and Chapel Hill, Chapel Hill, USA), arguments against.

The session will also include an edited case, to be presented by Gerry O’Sullivan (University Hospital Galway, Galway, Ireland), who will communicate lessons from early and late deep vein stent thrombosis.

Also to present in this session will be Mitchell Silver (Riverside Methodist Hospital, Columbus, USA), who will deliver a Podium 1st presentation on results from the CLEAR DVT study. Among other presentations, Samuel Money (Mayo Clinic, Phoenix, USA) will speak on ‘Robotic caval surgery for renal tumour and the Nutcracker Syndrome’.

In a section on venous wound controversies, a CX Debate will consider the motion ‘For patients with C6 disease, the iliac venous outflow should be routinely and specifically imaged’. Antonios Gasparis (Stony Brook University, Stony Brook, USA) will argue for the motion, while Alun Davies (Imperial College Healthcare NHS Trust, London, UK) will provide counter arguments.

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Lowell Kabnick 14:00–19:30 Monday 19 April Livestream 2 Could you summarise the highlights of your planned presentation for CX 2021?

I will be speaking on aggressive strategies for the ablation of incompetent perforators. After reviewing this topic in preparation for CX 2021, I am not sure that I can support such an approach. A number of my colleagues argue that it is important to have an aggressive strategy, while some, like me, really do not totally understand the physiology or pathophysiology of perforators. Some of us believe that perforator valves swing both ways, depending on the pressure in the system. However, we do not know for certain. This controversial topic is of crucial importance to the global vascular community as there is not enough high-level evidence to support either side.

What is the biggest controversial draw of the Superficial Venous & Lymphatic Superficial programme?

I think the biggest controversial draw would have to be the four debates.

They range from open surgery should be obsolete in 2021 for the treatment of superficial truncal reflux to preprocedure anatomy is enough to predict outcomes after deep venous stenting.

“I think the biggest controversial draw would have to be the four debates.

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14 CX 2021

Five debates to cover hot topics in the Acute Stroke programme

Acute Stroke Controversies

14:00–16:30 Thursday 22 April Livestream 2

The Acute Stroke programme at CX 2021, to be moderated

by CX Executive Board members Barbara Rantner (Ludwig Maximilian University, Munich, Germany) and Hugh Markus (University of Cambridge, Cambridge, UK) will feature five debates. Speaking to Vascular News, Rantner stressed the broad nature of the programme: “In the CX 2021 Acute Stroke session, we will cover a range of different topics.

Vertebral artery disease is underestimated and so we will include a debate on that issue; a large randomised trial has given new insights into vertebral artery stenting, so we decided to discuss that key topic; and—from a surgical point of view—we chose the topic of restenosis to see if carotid endarterectomy is still the treatment of choice in those patients.”

Carotid endarterectomy and stenting controversies

Peter Schneider (University of California San Francisco, San Francisco, USA) and Alun Davies (Imperial College Healthcare NHS Trust, London, UK) will debate the motion ‘Carotid artery stenting in asymptomatic patients is safe and effective’ and will argue against. Next on the agenda will be the statement ‘Only extracranial, not intracranial, vertebral arteries should be considered for stenting’, with Andrew Clifton (St George’s University Hospital NHS Foundation Trust, London, UK) arguing for the motion and Thomas Liebig (Ludwig Maximilian University, Munich, Germany) against. Finally, Gert de Borst (University Medical Center Utrecht, Utrecht, The Netherlands) and Maarit Venermo (Helsinki University Hospital, Helsinki, Finland) will assess the motion ‘Carotid artery endarterectomy is safe and effective in patients with symptomatic restenosis’.

Endarterectomy, stenting, and thrombolysis controversies The session will also cover controversies in endarterectomy, stenting, and thrombolysis via two CX Debates. The first debate will address the statement ‘Local anaesthesia is safer than general anaesthesia for carotid endarterectomy’, with HansHenning Eckstein (Technical University of Munich, Germany) presenting arguments in favour of the motion and Gert de Borst presenting arguments against. The final debate topic will be thrombolysis, with Wouter Schonewille (University Medical Center Utrecht, Utrecht, The Netherlands) arguing for and Shelley Renowden (Southmead Hospital, Bristol, UK) arguing against the motion ‘Thrombolysis is as effective as thrombectomy for basilar thrombosis’.

This session will also include a presentation titled ‘Mini-incision carotid endarterectomy is an effective alternative to TCAR [transcarotid artery revascularisation]: Safer, cheaper, and no metal left behind’, to be delivered by Enrico Ascher (NYU Langone Health, New York, USA).

Barbara Rantner 14:00–16:30 Thursday 22 April Livestream 2 What is the biggest controversial draw of the Acute Stroke programme at CX 2021?

It is difficult to really name only one big controversy. We will cover many key topics regarding carotid artery disease and also vertebral artery disease, addressing issues in asymptomatic patients and also in symptomatic patients, so it is difficult to focus on one hot topic.

However, asymptomatic carotid disease remains one of the most discussed issues and so we decided to do a debate focusing on the safety and efficacy of carotid artery stenting in those patients. Personally, I think this will be one of the highlight debates.

Why does the Acute Stroke programme matter to the global vascular community?

The Acute Stroke programme at CX 2021 matters to the global vascular community because we will debate unresolved issues in the field and highlight the most relevant topics of carotid artery and vertebral artery disease, with specialists from all over the globe. I think this is a great opportunity to get updates from all over the world on these pressing issues.

“ We will highlight the most relevant topics of carotid artery and vertebral artery disease with specialists from all over the globe.

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CX 2021 15

New dedicated session: CX 2021 to address key controversies in Vascular Trauma

Thoracic Vascular Trauma Aortic Controversies

17:00–19:30 Thursday 22 April Livestream 2

Programme highlight:

CX Executive Board members Christopher Aylwin (Imperial College Healthcare NHS Trust, London, UK) and Ross Davenport (Barts Health NHS Trust and Queen Mary University of London, London, UK) will moderate the first-ever dedicated programme on Vascular Trauma at CX. In the section on major vascular trauma controversies, Nigel Tai (The Royal London Hospital, London, UK) will address damage control surgery and decision-making for vascular surgeons and Karim Brohi (Queen Mary University of London, London, UK) will outline the evidence and controversies surrounding massive haemorrhage protocol.

Also in this section, Mark Edwards (Brighton and Sussex University Hospitals NHS Trust, Eastbourne, UK) will open a discussion on catastrophic pelvic haemorrhage, detailing controversies in managing the exsanguinating patient, whether by REBOA (resuscitative endovascular balloon occlusion of the aorta), pelvic packing, or IR (interventional radiology).

Three presentations will address torso intervention controversies.

Speaking on the topic of blunt aortic injury, Ounali Jaffer (Barts Health NHS Trust, London, UK) will summarise when to intervene, landing zone issues, and surveillance. Jan Jensen (Alabama-Birmingham School of Medicine, Birmingham, USA) will give a presentation titled ‘REBOA as an adjunct for vascular trauma haemorrhage: Pros versus cons, international experience, and moving to a consensus?’ and Elika Kashef (Imperial College Healthcare NHS Trust, London, UK) will detail when and for how long to use inferior vena cava (IVC) filters.

Experts in the field will also tackle venous and extremity vascular trauma controversies, with Todd Rasmussen (Uniformed Services University of the Health Sciences, Bethesda, USA) presenting on junctional injuries of the neck and axilla, and Tom Konig (Barts Health NHS Trust, London, UK) addressing damage control in the lower limb.

The final section of the programme will highlight training/vascular trauma practice controversies. Simon Glasgow (Guy’s and St Thomas’ NHS Foundation Trust, London, UK) will give a presentation on UK vascular trauma practice through the lens of TARN results; Lars Lönn (University of Copenhagen, Copenhagen, Denmark) will speak on ‘Developing a tool to assess competence in REBOA: An international Delphi consensus study’; and a CX Debate will address whether vascular surgeons are integral to all MHP trauma calls.

CX Debate to assess role of vascular surgeons in MHP trauma calls In a CX Debate, experts will consider the motion ‘Vascular surgeons are integral to all major haemorrhage protocol (MHP) trauma calls’. Jamie Coleman (Denver Health Medical Center, Denver, USA) will argue for the motion; Tal Hörer (Örebro University, Örebro, Sweden) against.

World leaders in many different areas of both vascular trauma and trauma will bring a wealth of knowledge and experience to the programme.”

Christopher Aylwin 17:00–19:30 Thursday 22 April Livestream 2 What is the biggest controversial draw of the CX 2021 Vascular Trauma programme?

The biggest controversy is likely to be the issue of REBOA (resuscitative endovascular balloon occlusion of the aorta), which will feature prominently on the programme.

This is a technique that places an endovascular balloon in the descending or infrarenal aorta for massive torso haemorrhage. For some, it is seen as a panacea. For others, it is seen as a potentially significant cause of morbidity and/ or mortality. The controversy remains as there have been no randomised controlled trials published to date.

This is the first time that there is a dedicated Vascular Trauma programme. Could you tell us briefly why that is important?

Trauma is the biggest killer in the world of those under the age of 40 and causes a huge morbidity in those patients who actually survive their traumatic injuries. For us to be able to present some of the controversies and tips and tricks that we have learned over the years is incredibly exciting, and we hope that as many people as possible will be able to join us for the session.

“Trauma is the biggest killer in the world of those under the age of 40 and causes a huge morbidity in those patients who actually survive their traumatic injuries.

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Conference coverage 17

LINC 2021

Head-to-head trials take centre stage in drug-eluting technology latebreaking session at LINC Data from two head-to-head trials on drug-eluting technologies in femoral artery treatment were presented during a late-breaking session at LINC 2021 (The Leipzig Interventional Course; 25–29 January, online)—one-year TRANSCEND and two-year COMPARE results. Both studies point to the non-inferiority of lowerdose paclitaxel devices, prompting discussion on whether these results will see a trend towards using lower-dose devices in practice. Although these results are promising, the panel agreed that more data are needed.

KENNETH ROSENFIELD (MASSACHUSETTS General Hospital, Boston, USA) presented one-year results of the TRANSCEND study, a non-inferiority randomised trial comparing the efficacy and safety of the SurVeil drug-coated balloon (DCB; Surmodics) versus the IN.PACT Admiral DCB (Medtronic), and Sabine Steiner (University of Leipzig, Leipzig, Germany) presented two-year results from the COMPARE trial, assessing the Ranger DCB (Boston Scientific) compared to the IN.PACT device.

All DCBs assessed utilise the anti-proliferative drug paclitaxel. The SurVeil and Ranger DCBs both have a low dose of paclitaxel (2µg/mm²) compared the the IN.PACT Admiral DCB, which has a higher dose of 3.5μg/mm².

TRANSCEND one-year results: SurVeil demonstrates non-inferior efficacy and safety versus IN.PACT Admiral

Rosenfield announced that primary results of TRANSCEND demonstrate the non-inferiority of the SurVeil DCB compared to the IN.PACT Admiral DCB with regards to both safety and efficacy, while delivering a substantially lower drug dose.

In the TRANSCEND trial, the SurVeil DCB was found to be non-inferior to the IN.PACT Admiral DCB in both the primary safety and primary efficacy endpoints. The SurVeil DCB cohort (n=222) exhibited a strong safety profile with 91.7% of subjects demonstrating freedom from device- or procedurerelated death within 30 days and freedom from above-ankle amputation or clinically-driven target vessel revascularisation (CD-TVR) within 12 months, compared to 89.6% of subjects treated with the IN.PACT Admiral DCB (n=224).

The SurVeil DCB group also met its efficacy endpoint of primary patency of 81.7% as compared to 85.9% of the IN.PACT Admiral DCB arm. In addition, the number of reinterventions deemed clinically necessary by physicians did not differ between the products.

COMPARE two-year results: Ranger continues to demonstrate similar patency rate to IN.PACT

Two-year results from COMPARE, the first head-tohead comparison of two DCBs with different paclitaxel dosages and coating technologies for femoropopliteal interventions, were also presented.

The study compared the lower paclitaxel dose Ranger DCB to the higher paclitaxel dose IN.PACT Admiral DCB. One-year results of COMPARE were presented for the first time during LINC 2020 (Leipzig Interventional Course; 28–31 January, Leipzig, Germany) and published concomitantly in the European Heart Journal.

At two years, the Ranger DCB, which has a significantly lower drug dose density of paclitaxel, continued to demonstrate a similar primary patency rate to the higher-dose IN.PACT DCB with a freedom

restenosis rate of 70.6% for the Ranger DCB (n=207) compared to the 71.4% observed with the IN.PACT DCB (n=207), according to the Kaplan-Meier estimate (p=0.96).

No significant differences were observed for other secondary two-year outcomes, Kenneth Rosenfield Steiner informed the LINC audience, detailing low all-cause mortality rates at twoyears with 3.6% for the Ranger DCB vs. 2.2% for the IN.PACT DCB (log-rank p=0.6).

In addition, there was a low clinically-driven target lesion revascularisation (CD-TLR) rate through two years—17.8% for the Ranger DCB vs. 13% for the IN.PACT DCB (p=0.3).

versus a high-dose balloon was also evident.

Both TRANSCEND and COMPARE assessed low-dose devices to the high-dose IN.PACT Admiral DCB. In the same late-breaking session, Thomas Zeller (University Heart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany) had presented long-term data on this device. Scheinert asked for his opinion on the results.

“We have to wait for longer-term follow-up data in order to see whether there will be a difference in terms of future safety endpoints,” Zeller remarked.

“However, it is interesting to see that all the data with the first-generation DCB [IN.PACT Admiral] are more or less in line, independently of whether the maker of this device has conducted the trial, or if this balloon was used as a control,” he added, highlighting the strong data available for the device.

In terms of whether this should herald a move towards low-dose devices, Zeller was unconvinced: “I do not see a reason to switch, and I do not know whether it is really necessary.”

Sabine Steiner Panellist Marianne Brodmann (University of Graz, Graz, Austria) also commented, echoing Rosenfield: “If a low-dose device is as safe and as efficient in the long term as a high-dose device, I think a lot of physicians might feel more comfortable to use a low-dose device.”

However, she also stressed that more data on these low-dose devices are needed.

Results for low-dose devices “reassuring,” but more data needed

Subsequent discussion focused on the significance of these results, with moderator Dierk Scheinert (University of Leipzig, Leipzig, Germany) posing the question: “Are low-dose balloons the way to go in the future?”

Rosenfield responded: “I think that this new generation of balloons is going to be better, and the safety data are comparable. If you are going to use multiple balloons in a given patient, I would certainly feel a lot more comfortable using a lower-dose balloon with better transmission of the drug and with less particulates downstream. I believe that this is going to be the way to go. Also, the technology is constantly improving.”

Steiner was in agreement, noting that the results are

We have to wait for longer-term followup data in order to see whether there will be a difference in terms of future safety endpoints.”

– Thomas Zeller “reassuring”. While the data from both TRANSCEND and COMPARE point in a similar direction, Scheinert was curious to know if there are any key differences between the datasets. “COMPARE included longer lesions, up to 30cm,” Steiner began, adding that it also included more chronic total occlusions (≈40% CTOs).

However, the speaker noted this design came at a price, referring to a much higher bailout stenting rate than TRANSCEND. Steiner also remarked that with the “more typical” design of TRANSCEND, with lesions of up to 18cm only, non-inferiority for a low-dose

2µg/mm² 2µg/mm² The SurVeil and Ranger DCBs both have a low dose of paclitaxel (2µg/ mm²) compared the IN.PACT Admiral DCB, which has a higher dose of 3.5μg/mm²

3.5µg/mm²

April 2021 | Charing Cross Special Edition

Advertorial 19

THIS ADVERTORIAL IS SPONSORED BY BENTLEY

Multicentre, physician-initiated study set to provide key data on bridging stents in FEVAR There are numerous covered stents on the market that are used as bridging stents in fenestrated endovascular aneurysm repair (FEVAR). However, these stents have always been used off-label for such procedures. Now, a physician-initiated study, in cooperation with Bentley, is set to change that with the aim of evaluating the safety and efficacy of the BeGraft peripheral balloon expandable covered stent (Bentley InnoMed GmbH, Hechingen, Germany) used as a bridging stent in FEVAR, with the wider goal of extending its indication in order to offer a proven solution that physicians can rely on.

E

ric Verhoeven, professor of vascular surgery at the General Hospital Nuremberg, Paracelsus Medical University in Nuremberg, Germany, is the principal investigator of the study and plans to enrol the first patient soon. In this article, Vascular News speaks to Verhoeven about FEVAR procedures, covering his expert opinion on the technique, key insights into what makes the ideal bridging stent, and what the FEVAR study means for the vascular community and patients alike.

What do you see as the main advantages of a FEVAR procedure over open surgery?

I work in a high-volume centre and in a recent publication based on our experience with FEVAR we had a mortality rate of 0.7%.1 This was a mixed group of patients with regard to surgical risk in which such a low mortality rate would never have been possible with open surgery. In our centre, FEVAR is routine and works very well, as we have the software, the hardware, the team, and the logistics to be able to perform such a complex procedure.

More generally, we offer this procedure when the anatomy is right and when we think there is a benefit for the patient. If you can perform a FEVAR so that the patient can go home three days later and you can stay out of the abdomen—which should not be opened unless it is really necessary—I would recommend it.

What are the specifications of an ideal stent for FEVAR and why are none of the available stents indicated yet?

The ideal bridging stent for FEVAR needs strength, radial force, and must be able to be flared and riveted in the fenestration. Eventually, it would be ideal if bridging stents for FEVAR become softer and smoother in their distal part, so that they could follow the path of the vessel better.

Bentley is the first company that was prepared to move forward by testing their stent grafts with the aim of getting them on-label for FEVAR procedures. While the FEVAR procedure has become standard care and the first option for many patients, it is still an off-label procedure, and that is why we are conducting a study, so that we can get this particular bridging stent graft— the BeGraft—on-label in FEVAR.

The end goal is that the BeGraft will be the first on-label balloon expandable covered stent to be used in fenestrations.”

What can go wrong in a FEVAR procedure?

We are at the stage where next to nothing can go wrong anymore because we have the right devices.

Occasionally, you cannot get into the target vessel, but I must say that this is extremely rare. In fact, I cannot recall one in the last 100 cases.

We have improved our skills over the years, we have better materials, and we have better options, for example with steerable sheaths or indwelling catheters, so it would be extremely rare to not be able to target the vessel and to stent it correctly.

Having said that, what can always occur is a dissection in the target vessel, because of difficult handling, and sometimes a wire perforation. This occurs in perhaps 1–2% of target vessels but demonstrates that these procedures are technically demanding and should be executed by a well-trained team. Overall, the patency rates of the target vessels are extremely high—in the mid-90%.

How essential is it to select the right bridging stent in FEVAR procedures?

Bridging stents are essential in a FEVAR procedure because we need a fairly strong stent that remains open, that can be flared, and that can be moulded.

The BeGraft and the Advanta V12 (Getinge) are good examples of such a stent.

Angiography after the BeGraft was deployed and flared in a right renal artery

Close up of the BeGraft in a right renal artery

What do you like about the Bentley BeGraft stent and could it be considered an ideal bridging stent?

The BeGraft is a second-generation bridging stent and it is something that has been developed and adapted to the needs of physicians over the years. It has been redesigned so that the BeGraft is now stronger, thicker, and better overall. In addition, the BeGraft PLUS can be used for branches, which consists of two layers of expanded polytetrafluoroethylene (ePTFE) and two stents.

Besides the fact that the regular BeGraft has a high radial force, good handling and visibility, and that the flaring works well, the biggest advantage is the fact

Eric Verhoeven

that it is 6F compatible, which is ideal if you have preloaded fenestrated grafts where you only have a 6F channel. In general, a 6F guiding sheath will track difficult anatomy better than a 7F guiding sheath, which is a huge advantage.

Finally, the BeGraft comes in many lengths and in short intervals, like 27/28mm. In the majority of cases, these are ideal lengths for a bridging stent in FEVAR, not too short and not too long.

Is there an option for the BeGraft PLUS to be used in FEVAR procedures?

You could use the BeGraft PLUS in FEVAR procedures if you had a very calcified vessel for which you need more radial force, which is a key feature of the BeGraft PLUS. This is not needed in 95% of the FEVAR target vessels. You could also use the BeGraft PLUS in FEVAR if you had a longer gap to bridge—like in BEVAR cases.

What do you expect from the FEVAR study?

This FEVAR study, which is approved by the German authorities BfArM, is a physician-initiated trial in cooperation with Bentley and the foundation for cardiovascular research and education (FCRE), and we are very grateful for their support because what we want to achieve is to get on-label approval for the bridging stents. Also involved are seven other investigators who work in experienced centres across Germany: Martin Austermann (St Franziskus-Hospital, Münster), Nikolaos Tsilimparis (Ludwig-Maximilians University Hospital, Munich), Kyriakos Oikonomou (University Hospital Regensburg, Regensburg), Drosos Kotelis (RWTH Aachen University, Aachen), Philipp Geisbüsch (Stuttgart Hospital, Stuttgart), Johannes Kalder (University of Giessen, Giessen), and Mario Lescan (Tübingen University Hospital, Tübingen).

We need to include 100 patients and with that we should have data from at least 250 BeGrafts in fenestrations with a follow up of 24 months. We should be able to demonstrate its technical safety, durability, and that it is a favourable choice in FEVAR. The end goal is that the BeGraft will be the first on-label balloon expandable covered stent to be used in fenestrations.

References 1. V erhoeven EL, Katsargyris A, Oikonomou K, et al. Fenestrated endovascular aortic aneurysm repair as a first line treatment option to treat short necked, juxtarenal and suprarenal aneurysms. Eur J Vasc Endovasc Surg 2016;51(6): 536-42.

April 2021 | Charing Cross Special Edition

Journal updates 21

AORTIC

UK AAA screening results show “considerable” local variation in proportion of patients undergoing endovascular repair

The first detailed surgical results from the UK National Health Service (NHS) Abdominal Aortic Aneurysm Screening Programme (NAAASP) show that, over a seven-year period, the turn down rate after referral for treatment with a screen-detected AAA and perioperative mortality were low. However, the data also reveal that there remains “considerable” variation between local screening programmes in the proportion undergoing endovascular repair. These findings were published in the February edition of the European Journal of Vascular and Endovascular Surgery (EJVES).

A

uthors Lewis Meecham (Heart of England NHS Foundation Trust, Birmingham, UK) and colleagues detail that the NAAASP began implementation in 2009, and became fully operational in 2013. Since that time, all men in England with a large aneurysm >54mm, either at first screen or during surveillance, are referred for intervention.

In order to see whether there has been any local variation in treatment rates and types of repair, the investigators aimed in this study to explore the outcomes of all men referred to a vascular network with a large AAA diagnosed through screening between 1 April and 31 December 2016. Meecham et al relay that basic demographic information,

nurse assessment details, as well as outcome data were extracted from the national NAAASP IT system, AAA SMaRT, for analysis.

In the seven-year study period, the authors note that 3,026 men were referred for possible intervention (48% first screen, 52% surveillance). They specify that while 448 men (13.3%) either declined (63; 2.1%) or were turned down for early intervention for various reasons (385; 12.7%), 8% were declined for medical reasons (true turn down rate). Men referred from surveillance were older, and more likely not to have had elective surgery within three months (16 vs. 11.2%; hazard ratio [HR], 1.37; 95% confidence interval [CI], 1.07–1.75, p=0.011), Meecham

and colleagues write in the EJVES. In addition, the authors report that turn down rates did not vary among local programmes, when men under surveillance were taken into account.

Regarding mortality, the investigators report that 2,624 (87%) men had planned AAA repair, with a perioperative mortality of 1.3%. They add that 30day surgical mortality was lower after endovascular aneurysm repair (EVAR): 0.4% compared with 2.1% after open repair.

The method of repair remained consistent year on year, Meecham et al communicate, with roughly equal numbers undergoing endovascular (50%) and open surgical repair (48%); 2% unknown. However, the “striking finding” of the study was that there was variation among local screening programmes in the proportion treated by endovascular repair: from 20% to 97%.

In the discussion of their findings, the investigators consider possible explanations behind this “very wide range” of EVAR use for screen-detected AAA. “This proportion should not have been affected by the number of complex endovascular repair,” they write, noting that procedures done in tertiary centres are still counted in their

“Significant” long-term morbidity related to aortic branches in patients with aortic dissection

In patients with aortic dissection, a retrospective, population-based cohort study suggests that aortic branch involvement is responsible for “a significant long-term morbidity, without any related mortality”. This finding was recently published online in the Journal of Vascular Surgery (JVS).

AUTHORS FRANCESCO SQUIZZATO (MAYO Clinic, Rochester, USA) and colleagues add that type B aortic dissection, patency of the aortic false lumen, or malperfusion syndrome at presentation had a higher risk of branch events during long-term follow-up.

Furthermore, they write that dilatation of the aortic branches was observed in one-third of cases, in particular in the case of a patent aortic false lumen or Marfan syndrome.

Prior to their investigation, the authors note that late morbidity and mortality related to aortic branches in patients with aortic dissection were “not well described” in the literature. Therefore, it was their aim to investigate the fate of aortic branches in a cohort of patients with newly-diagnosed aortic dissection.

Using the Rochester Epidemiology Project record linkage system, the researchers identified all residents in Olmsted County, USA, diagnosed with aortic dissection from 1995 to 2015. They included only patients with >30 days of available follow-up imaging in the analysis.

Squizzato et al detail that the primary outcome of the study was freedom from any branch-related event (which the authors define as being any intervention, aneurysm, malperfusion, rupture, or death occurring

after the acute phase >14 days) and that the secondary outcome was diameter change of the aortic branches.

Of 77 total incident aortic dissection cases, the authors note that 58 patients who survived with imaging follow-up were included in the study—28 (48%) with type A and 30 (52%) with type B aortic dissection—and that the presentation was acute in 39 (67%) cases and six (10%) had branch malperfusion.

Of 177 aortic branches involved by the aortic dissection, they add, 81 (46%) arose from the true lumen, 33 (19%) from the false lumen, and 63 (36%)

Type B aortic dissection, patency of the aortic false lumen, or malperfusion syndrome at presentation had a higher risk of branch events during long-term follow-up.”

originating programme.

They add that the differences do not seem to be related to patient factors either, leading them to conclude that it is likely to represent variations in local uptake of EVAR technology.

“The question is what to do with this information,” they write, “as by definition, variation results in inequity”.

Meecham et al also remark on how the recent publication of the UK National Institute for Health and Care Excellent (NICE) guidelines on the management of AAA might influence future outcomes. “The draft version of the document suggested that EVAR was not a cost-effective elective intervention,” they state, adding that this approach has been “softened” in the definitive document.

“It is possible there may be a reduction in the number of EVAR procedures as a result,” the authors posit, going so far as to say that there may even be a decrease in all elective surgical procedures for AAA. They write that this would have “a number of significant consequences” for AAA screening. They suggest that it would increase population risks of death from AAA rupture, and, by definition, make the screening programme less effective.

There was variation among local screening programmes in the proportion treated by endovascular repair: from

20%

to

97%

from both.

Squizzato and colleagues also relay that, after the acute phase, freedom from any branch-related event at 15 years was 48% (95% confidence interval [CI], 32–70). In addition, they state that 31 branch-related events occurred in 19 patients over 15 years: 12 interventions (76% freedom; 95% CI, 63–92), 10 aneurysms (67% freedom; 95% CI, 50–90), eight malperfusions (76% freedom; 95% CI, 61–94) and one rupture (94% freedom; 95% CI, 84–100). There were no branch-related deaths, they report.

Writing in JVS, the authors further detail that type B aortic dissection (hazard ratio [HR], 3.5; 95% CI, 1.1–10.8; p=0.33), patency of the aortic false lumen (HR, 6.8; 95% CI, 1.1–42.2; p=0.038) and malperfusion syndrome at presentation (HR, 6; 95% CI, 1.3–28.6; p=0.023) were predictors of late aortic branch-related events.

Squizzato et al acknowledge some limitations of the present study, including its retrospective nature, which may have led to “inherent biases” due specifically to the initial code-based identification of patients with aortic dissection. Also, they recognise that the limited number of patients included in the final cohort “may have limited the power of the statistical analysis”.

In particular, they write that it was not possible to discriminate the effect of complete versus partial thrombosis of the aortic false lumen on branch-related complications.

Despite these drawbacks, the authors also highlight a number of key strengths to their study. They explain that the population-based approach, for example, allowed them to gather detailed follow-up information and to report reliable long-term follow-up results, since their patient cohort was not subject to the referral bias usually noted in registry or single-centre reports.

Charing Cross Special Edition | April 2021

22 Interviews

A Year in Profiles The last year of Vascular News profile features has seen key leaders in the field share important lessons and advice based on notable careers. This overview of their individual in-depth interviews is an annual look back at their insights and experiences.

Roberto Chiesa

Issue 87 September 2020

The vascular surgeon of the future will have to know both open and endo solutions for every disease, and be skilled in using and combining them.”

IN JULY 2020, Hence Verhagen spoke to Vascular News about his career in vascular Issue 86 surgery to date.

He lauded the July 2020 impact of the shift from open to endovascular techniques, but stressed that treatment results must get “a lot more durable” in the future, and encouraged those starting a career in vascular surgery to go out of their comfort zone “regularly”. At the time of the interview, Verhagen was about to become 2021 president of the European Society for Vascular Surgery (ESVS), and he considered his objectives for this role.

Verhagen detailed that his interest in vascular surgery can be traced back to the role of an inspirational figure and mentor: “I had the pleasure of meeting Professor Bert Eikelboom early during my time at medical school. He inspired me and offered me the opportunity to do some research programmes. After a few years, he offered me a PhD position. Eikelboom was a prominent leader in the field of endovascular repair of the aorta in The Netherlands and Europe and his work convinced me that I should pursue a career in vascular surgery.”

Verhagen also considered what have been the most significant developments in the vascular field over the course of his career, highlighting the shift from open to endovascular techniques.

This development “revolutionised” the vascular surgery arena and “made the profession so much

Hence Verhagen

FROM HIS EARLY DAYS IN CARDIAC SURGERY through to his professorship in Milan, Italy, Roberto Chiesa spoke to Vascular News in September about various aspects of his career so far. He stressed the importance of being skilled in both open and endovascular techniques and imparted some advice to those starting careers in vascular surgery.

Chiesa detailed his early interest in transplant surgery.

“In particular, I was struck by the first heart transplantation performed by Christiaan Barnard in 1967 and I decided to enter the world of cardiovascular surgery,” he explained.

“The first part of my professional life was spent in the cardiac surgery departments directed by Magdi Yacoub; with him I performed heart and lung transplantations for two years.”

Looking back on how the field of vascular surgery has changed, Chiesa commented that it is “completely different” now compared to what it was 50 years ago when he started his career. “The most incredible change was the advent of endovascular techniques and their spread during the beginning of this century. Now, I can offer a chance to a large number of patients who would have been considered unfit for surgery in the past.”

He continued: “Also, some paradigms of treatment have completely changed, including acute type B dissection and thoracic aorta trauma.

We were used to treating these urgent conditions with open surgery, with

more interesting and appealing,” he told this newspaper. “When I look at all the minimally invasive interventions we do, how this impacts the life of our patients and their relatives, and the enthusiasm with which the young vascular surgeons master these techniques, I can be part of this huge change in the landscape. What a difference this is from the first few years in the field!” he remarked.

Looking ahead, Verhagen stressed that there is still work to be done with regards to endovascular surgery. “Treatment results need to get a lot better and a lot more durable,” he said. “There is still a lot to gain there. I cannot think of a world where we go back to open surgery.”

Soon-to-be ESVS president at the time, Verhagen outlined what he hoped to achieve in the role.

“My goal is an even better connection between the ESVS, the academy, and young vascular surgeons for whom the additional value of an ESVS membership is more clear. Furthermore, I will also try to further professionalise the way the ESVS is run, and make improvements to the business model to have a more sustainable organisation.

Finally, reaching out to other professional societies in cardiology, radiology, vascular medicine, angiology, and cardiothoracic surgery to establish better interaction is high on our agenda.”

When asked what had been the proudest moment of his career to date, Verhagen responded that “there are so many proud moments”. Not able to pick one, he listed the following as career highlights: “seeing your fellow perform a successful intervention, saving a patient’s life during an emergent intervention, and presenting important new data at a conference. So much to be proud of!”

high operative mortality. Today, the approach is endovascular in almost all cases, with really improved outcomes. But endovascular techniques are not a ‘panacea’, and may have significant complications, especially in the long term. I think that endovascular treatment should be performed only by surgeons who can also offer the open surgical counterpart, which means they can decide impartially what is the best solution for every specific situation.”

Chiesa posited that endovascular techniques “will continue to evolve, and will obtain even better results for an increasing number of patients”. However, he also expects that there will be an upswing in open surgery, in selected situations, and is why he strongly believes open surgery “must be taught to younger generations”. He remarked: “The vascular surgeon of the future will have to know both open and endo solutions for every disease, and be skilled in using and combining them, tailoring their decisions to patients’ needs. Probably also robotic surgery will enter our field, and its principles should be known by future generations.”

Considering the proudest moment of his career to date, Chiesa noted his presidencies of the French Vascular Surgery Society (SCVE) in 2013, and president of the Italian Vascular Surgery Society (SICVE) in 2015.

In both of these roles, he detailed that an important goal was to improve the participation of young vascular surgeons in the activities of the Societies.

Addressing those starting careers in vascular surgery, Chiesa advised: “attend different high-level vascular surgery centres in order to learn both open and endovascular surgery; read at least two scientific journals every month; and to pull yourself back together when something goes wrong.”

April 2021 | Charing Cross Special Edition

Xxxxx Xxxxxx Chris Imray

Issue 88 November 2020

The vascular surgeon is very much the conductor of the complex and interrelated orchestra.”

Interviews 23

PRESIDENT OF THE VASCULAR SOCIETY FOR Great Britain and Ireland (VSGBI) 2019–2020 and avid climber Chris Imray spoke to Vascular News in November 2020 about his career in vascular surgery to date. He outlined his continued research into how the brain responds to hypoxia and ischaemia, and highlighted a “particularly important” study into COVID-19 and vascular surgery.

Imray trained at Charing Cross Hospital (London, UK) in the early 80s and within the first year or so, he recalled that he was “certain” he wanted a career in general surgery.

“The particular sub-speciality at the time did not seem that important. I am sure I was influenced by a number of surgeons but Keith Reynolds, an upper gastrointestinal tract surgeon stands out in my memory,” he relayed.

Over the course of his career, Imray noted that he has seen a gradual shift away from “the individual hero” to team-based procedures. “In the early 80s vascular surgery was very much an open speciality, where ‘heroic’ procedures were undertaken by heroic surgeons. At that time in my career, that seemed like a very exciting prospect and it was probably one of the reasons I was drawn into it.” Nowadays, he stated that “the vascular surgeon is very much the conductor of the complex and interrelated orchestra”.

Looking ahead, Imray stated his belief that the patient voice is “finally being recognised as a key component in the decisionmaking,” which is “probably somewhat overdue”. In addition, he stressed that understanding the fitness

IN JANUARY 2021, Julie Ann Freischlag spoke to Vascular News about her career in the field, at a Issue 89 time when she had January 2021 just been elected as president-elect of the American College of Surgeons (ACS) for 2021–2021. Freischlag outlined what she hopes to achieve during the presidency, and also considered what the future of the field might hold.

Contemplating her goals for the presidency of the ACS, Freischlag hopes to take forward some positive developments that have emerged during the COVID-19 pandemic—such as the use of telehealth—and also to continue the work of her predecessors on promoting vascular workforce diversity. “I hope to be able to continue the work of J Wayne Meredith in racial equity for our patients and to increase the number of diverse individuals who become surgeons. Presently, 30% of vascular surgeons are women and only 2.5% of vascular surgeons are African American.

“Also, I hope to lead post-pandemic in a way that makes us keep the good things we learned from the situation, such as virtual meetings, telehealth visits— especially for postoperative patients—and flexibility in all aspects of the workplace.

We need to better understand the disparities in healthcare access and outcomes in order for us to be much better healthcare providers for all in the future.”

Freischlag stated her belief that, over the next decade, prevention of disease will improve. “We have seen improvements due to a

Julie Ann Freischlag

of the individual and “fine-tuning” the best choice between an open, hybrid, or endovascular approach will become increasingly important. “I think this will begin to help us as we improve on data collection, giving us a better idea as to which is the most appropriate personalised intervention,” he commented.

In terms of his current research, Imray communicated that he is particularly interested in fitness for surgery, multidisciplinary team working, and how the brain responds to hypoxia and ischaemia. “I was very excited that, just prior to COVID-19, we managed to get 12 patients through a phase one pharmaceutical interventional study giving dexamethasone to try and prevent simulated high altitude cerebral oedema. Unfortunately, with COVID-19 this has all been put on hold, but I am hoping we will be able to get this up and running again shortly. We have previously shown that 24 hours of 12% oxygen can simulate MRI [magnetic resonance imaging] measurable cerebral oedema and the question here is whether or not intravenous dexamethasone can mitigate this, and by what mechanism.”

Asked which new research paper had caught his attention, Imray highlighted the COVER study, led by the trainee Vascular and Endovascular Research Network looking at the impact of COVID-19 on vascular surgery. He stressed that his will turn out to be “a particularly important study” and remarked that “we are likely to look back even in 10 or 15 years’ time and reflect upon the secondary impact that COVID-19 has had on our lives and particularly our high-risk vascular patients.”

decline in smoking, but better exercise and diet, and treatment of high cholesterol and high blood pressure will also yield positive results. In addition, as our vascular patients are living longer and better lives, I expect to see improved longevity of endovascular devices, so that patients can enjoy them without reintervention.”

Despite these positive predictions, however, Freishlag stressed that prevention of disease is also one of the biggest challenged currently facing vascular surgery. “We need to be able to perform fewer procedures, as the cost and complexity of these interventions—although interesting and challenging— are making our health system unaffordable. Educating our patients so that they can participate with us in preventing and treating their vascular disease is really important.”

In 2013, Freischlag became the first female president of the Society for Vascular Surgery (SVS).

Speaking to Vascular News, she assessed what could be done to improve the number of women pursuing a career in vascular surgery.

“The number of women going into vascular surgery is increasing. One of the reasons for this is that students and residents see women vascular surgeons now and know that they too can pursue that career. The issues of work–life balance will always be there, but this exists for both women and men.

“We do need to improve on the calling out of both macro- and micro-aggressions, most of which are aimed at women and others who are not white male surgeons. This is getting better, as the new generation is much more diverse in their thinking.

“We also need to teach leadership in medical school. We can all lead and we all need to lead— whether it is your division, your team in the operating room, your research laboratory, or your group practice—we all can lead and make the experience for our patients and co-workers better.

Women need to ask for and take leadership positions because when you are in charge, you can make the rules. When you are not in charge, you can only influence.”

We need to better understand the disparities in healthcare access and outcomes.”

April 2021 | Charing Cross Special Edition

Positive firsttime data presented at LINC for IN.PACT AV DCB and Ellipsys system New data presented for the first time at LINC 2021 (The Leipzig Interventional Course; 25–29 January, online) support the use of drug-coated balloons (DCBs) as a treatment for dysfunctional arteriovenous fistulas (AVFs). The audience also heard the case for percutaneously-created AVFs with the Ellipsys vascular access system (Medtronic).

ONE-YEAR RESULTS FROM the IN.PACT AV Access study demonstrate superior target lesion primary patency outcomes for DCB angioplasty compared to percutaneous transluminal angioplasty (PTA) for the treatment of de novo or restenotic obstructive lesions of native AVFs in the upper extremity. So said Andrew Holden (Auckland Hospital, Auckland, New Zealand), addressing attendees virtually.

Alongside Holden, Robert Lookstein (Ichan School of Medicine at Mount Sinai, New York, USA) and Hiroaki Haruguchi (Haruguchi Vascular Access Clinic, Tokyo, Japan) are principal investigators of the IN.PACT AV Access investigational device exemption (IDE) study, which evaluated the IN.PACT AV DCB (Medtronic) versus PTA. They conducted a global, prospective, 29-centre, 1:1 randomised, singleblinded study evaluating the safety and effectiveness of DCB angioplasty versus PTA in dysfunctional AVF, following 330 patients out to five years.

Each patient enrolled in the study had lesions up to 10cm in length in the native AVF. The primary safety outcome was measured by the serious adverse event rate involving the AVF access within 30 days of the procedure. The primary effectiveness outcome was defined as freedom from clinically-driven target lesion revascularisation (CD-TLR) or access circuit thrombosis, measured through six months post-procedure.

One year after intervention, target lesion primary patency was 65.3% in the DCB group, and 46.3% in the standard PTA group (p<0.001). Access circuit primary patency was also higher amongst the IN.PACT AV DCB cohort: 55.1% vs. 35% (p<0.001).

The subset outcomes of the IN.PACT AV Access trial through 12-months

were presented for the first time.

Assessing the 12-month data by lesion type, Holden informed the virtual LINC audience that the IN.PACT AV DCB arm demonstrated superior patency in both de novo and restenotic lesions compared to the standard PTA arm. Target lesion primary patency was achieved in 77.5% of de novo lesions treated with the IN.PACT AV DCB (31 of 40), compared to in 61.9% of de novo lesions treated with standard PTA (26 of 42); confidence interval (CI), -4–35.2%. In restenotic lesions, target lesion primary patency was also higher in the DCB group than the standard angioplasty one: 58.4% (59 of 101) versus 35.7% (35 of 98); CI, 9.2–36.2% Looking at the data by type of AVF, the IN.PACT AV DCB group achieved better target lesion primary patency at 12-months for all subgroups: radiocephalic (64.5% vs. 47.2%; CI, 1.5–33%), brachiocephalic (63.8% vs. 41.2%; CI, 3.4–41.9%), and brachiobasilic (61.5% vs. 45.4%; CI, -23.5–55.6%). Commenting on these results, Holden told delegates: “Fewer reinterventions are needed to maintain target lesion primary patency in the DCB group compared to the PTA group. We saw a 56% reduction in reinterventions at six months, and a 35.4% reduction in reinterventions at 12 months.

“Through 12 months, sustained superior target lesion primary patency was achieved with DCB in restenotic lesions, and both forearm and upper arm AVF types. Subset analysis of lesion location showed a patency advantage for IN.PACT AV DCB over standard PTA for all lesion locations in the access circuit but particularly at the arterial inflow, anastomosis and cephalic arch.”

Percutaneous AVF creation with Ellipsys faster, and “easier to salvage” than surgically-created AVFs

In a comparison of surgical and percutaneous AVF creation, Robert Shahverdyan (Asklepios Clinic Barmbek, Hamburg, Germany) told LINC 2021 attendees that whilst surgical AVFs have a higher primary patency and fewer reinterventions, percutaneous AVFs with the Ellipsys vascular access system (Medtronic) have a higher technical success rate, faster procedure times, higher assisted, secondary patency and maturation rates, faster cannulation times, and fewer abandonments.

There are currently two systems

Through 12 months, sustained superior target lesion primary patency was achieved with [the IN.PACT AV] DCB in restenotic lesions – Andrew Holden

available on the market that allow for AVFs to be created percutaneously: the Ellipsys vascular access system and the WavelinQ 4F endoAVF system from BD. Comparing these two endovascular AVF options with the surgical Gracz technique, the investigators have created over 500 new vascular accesses during the study period in total, from which Ellipsys was used in 116 patients, WavelinQ 4F in 41 patients, and Gracz

surgical AVF creation was performed in 90 patients.

Technical success was 100% in the Ellipsys and surgical Gracz groups, and 92.7% in the WavelinQ group.

“Anastomosis is very important,” Shahverdyan said, before sharing that 100% of anastomoses were radial in the Ellipsys group, while 61% were radial in the WavelinQ groups (a further 34.1% were ulnar), and 37% were radial in the Gracz group (an additional 12% were ulnar, and 51% were brachial). Commenting on the fact that half of surgical AVFs were brachial, Shahverdyan noted: “Anastomosis [location] is not only important for the flow, but also after a failed endoAVF, you could still create a brachial artery based anastomosis [surgically]”.

The procedure time was significantly shorter when using the Ellipsys, with a median time of 13 minutes versus 62 minutes in the WavelinQ arm and 69 minutes in the Gracz arm.

“This is where it gets interesting,” Shahverdyan enthused. He shared that maturation at four weeks “is similarly high for Ellipsys and Gracz” (78.4% and 80%, respectively), and that they observed total maturation in 88% of patients for both these groups.

Time to cannulation in dialysis patients was shorter for Ellipsys procedures (52 days vs. 69 days in the surgical cohort), and, although there were more interventions in the endoAVF groups, fewer Ellipsys AVFs were abandoned or converted to another fistula (12.3% vs. 36.6% in the WavelinQ group and 15.6% in the surgical group).

At six months, one year, and two years, primary patency was highest in the surgical Gracz group (68%, 53%, and 42%, respectively). The Ellipsys had the second highest primary patency at all time points (50%, 34%, and 27%, respectively), whilst primary patency with WavelinQ was lowest (35%, 27%, and 23%, respectively). However, assisted patency rates at six months, one year, and two years were similarly high for Ellipsys (83%, 77%, and 77%, respectively) and Gracz (84%, 80%, and 78%, respectively) groups, and secondary patency rates were slightly, but not significantly, higher for Ellipsys-group (89%, 87% and 87%) versus Gracz-group (855, 82% and 82%).

“To conclude,” Shahverdyan said, “Ellipsys percutaneous AVF expands the options for a valid, long-term AVF creation in our patients.”

April 2021 | Charing Cross Special Edition

Arterial diameter may help to predict AVF aneurysm progression, study suggests A recent study concludes that arterial diameter may influence arteriovenous fistula (AVF) aneurysm progression and the interval to surgical revision. “Patients with larger arterial diameters should be monitored closely and referred early after aneurysm development,” authors Alexis M Cahalane (Massachusetts General Hospital, Boston, USA) and colleagues write in an online article in The Journal of Vascular Access (JVA).

ANOTHER KEY FINDING FROM the study was that radiocephalic AVFs are more resistant to aneurysm development, and “should be considered the first access option for ESRD [end stage renal disease] patients, especially younger patients,” the authors communicate.

This study included all patients who underwent fistula surgical revisions due to aneurysms between 1 January 2014 and 30 July 2016.

Cahalane and colleagues identified 45 eligible patients in the AVF aneurysm group and 24 in the control group, with the mean age of AVF creation being older in the control group (61.8 vs. 53 years, p=0.03).

Writing in JVA, they report that the mean interval between AVF creation and first fistulogram in the study group was 1,464±282 days, compared to an interval of 263±101 days in the control group (p=0.003). Cahalane et al added that the arterial diameter on first fistulogram (r=0.6, p=0.03) predicted maximum aneurysm diameter on the last fistulogram (r=0.6, p=0.03) as well as the interval between first fistulogram and surgical revision (r=0.33, p=0.03).

The authors note that the study group contains only a small number of patients with heterogeneous distribution of AVFs in terms of laterality and location. They explain the reasons behind this: “The overall five-year survival rate for ESRD patients receiving haemodialysis was recently found to be 42%, and aneurysms are a late complication of access, with the average follow-up in our study being 1,324 days. Thus, a small number of patients met the study criteria.”

New standardised reporting system suggests arteriovenous graft infections may be less frequent than previously described

“Using an objective system that discriminates between aetiology and outcome allows a more complete, objective understanding of relative infection risks and outcomes for arteriovenous grafts (AVGs).” This is the conclusion of a review published online in The Journal of Vascular Access (JVA). Authors David Kingsmore (Queen Elizabeth University Hospital, Glasgow, UK) and colleagues suggest that such a system can inform discussions with patients requiring vascular access for haemodialysis.

THE AUTHORS FOUND THAT AVG INFECTION WAS NOT COMMON, that it was caused by a systemic infection in only one-third of patients, did not lead to metastatic infection, and, “importantly,” was treatable without loss of access in one-half of all cases.

The investigators performed a single-centre series analysis of 277 early-cannulation AVGs with a minimum of one-year follow-up.

Writing in JVA, Kingsmore and colleagues report that 16% of all AVGs implanted, representing 51 episodes, developed infection related to the AVG. However, they also relay that more detailed analysis shows that this can be broken down into the following results: primary AVG infection (related to the insertion procedure or within 28 days) occurred in only 3% of AVGs assessed, or nine times; secondary AVG infection (related to AVG in use) occurred 33 times (rate 0.27/1,000) haemodialysis days), at a mean of 382 days; and tertiary AVG infection (in AVG no longer in use) occurred nine times. Finally, they add that only one-third of all AVG infections led to bacteraemia, and that one-half did not lead to loss of functional access.

VasQ external support awarded NUB Status 1 reimbursement renewal for 2021 for 321 hospitals The German Institute for Hospital Remuneration (InEK) has renewed the new examination and treatment methods (NUB) Status 1 designation of VasQ external support (Laminate Medical Technologies) for 2021.

NUB STATUS 1 PROVIDES SUPPLEMENTAL reimbursement for innovative medical devices that have the potential to improve the standard of care for patients. VasQ external support first received NUB Status 1 in 2017 with 35 participating hospitals and has since grown to 321 participating hospitals to date, which represents the second most among devices that serve the dialysis patient population.

The VasQ external support is implanted around the anastomosis during the creation of an arteriovenous fistula (AVF) to promote more usability without the need for the frequent additional procedures typically required for standard AVFs. AVFs created with the VasQ external support have reported in publications and presentations usability rates as high as 86% or better by six months in seven clinical studies. Growing clinical evidence in support of VasQ as well as the building momentum of usage in InEK calculating hospitals are critical components to support a permanent diagnosis-related group (DRG) code for reimbursement.

“My practice relies on VasQ as our standard of

care for creating almost all of our forearm and upper arm surgical fistulas,” stated Robert Shahverdyan, head of Vascular Access Center Hamburg at Asklepios Klinik Barmbek (Hamburg, Germany).

“The device has improved my fistula outcomes for my patients, and I am grateful for the NUB designation so my work with VasQ can continue with sufficient reimbursement to cover the additional costs of the device.”

The device is currently being implanted across Europe under a CE mark and has also completed enrolment in an investigational device exemption (IDE) pivotal clinical study to be evaluated by the US Food and Drug Administration (FDA) through the de novo pathway for use in the USA. The FDA has already awarded the device a breakthrough designation based on the breadth of clinical evidence collected so far for VasQ that consistently demonstrates improvement over the standard of care for AVF creation. The designation provides VasQ with the substantiation of clinical improvement required by the Centers for Medicare

and Medicaid Services (CMS) for providing additional reimbursement for new technologies once cleared for the US market.

VasQ device improves AVF creation in haemodialysis patients

VasQ could be protective against the haemodynamic modifications that occur during arteriovenous fistulae (AVF) creation, a recent article in The Journal of Vascular Access reports. Roberto Palumbo (Saint Eugenio Hospital, Rome, Italy) and co-authors caution that their results, which derive from their clinical experience and are thus representative of a “real-life setting”, should be considered preliminary.

The designation provides VasQ with the substantiation of clinical improvement required by the CMS for providing additional reimbursement for new technologies once cleared for the US market.”

27

Charing Cross Special Edition | April 2021

28 Journal updates

PERIPHERAL

Acute kidney injury is associated with mediumterm mortality following endovascular intervention for PAD Acute kidney injury is a common complication after intervention for peripheral arterial disease (PAD), and is associated with “medium-term mortality” following percutaneous transluminal angioplasty (PTA), a new study in the British Journal of Surgery (BJS) finds. Authored by Emmanuel Katsogridakis (National Institute for Health Research, Leicester Biomedical Research Centre, University of Leicester, Leicester, UK) and colleagues, the paper concludes that while the present work makes evident the fact that the development of acute kidney injury is independently associated with medium-term mortality at two years, the observational nature of the study means the authors “cannot fully elucidate the pathophysiological mechanisms underlying this association”. They call for future research using relevant subclinical markers and mechanistic assessments to shed light on this.

SYMPTOMATIC PAD IS frequently managed with PTA, particularly in patients with significant comorbidities, including chronic kidney disease (CKD) and cardiovascular disease. These patients are at risk of developing acute kidney injury after PTA. Postprocedural AKI is not innocuous, the authors write, even for patients with a transient decline in renal function, as it is strongly associated with more complications and a higher financial burden for healthcare providers.

As the incidence of, and risk factors for, acute kidney injury after endovascular intervention for PAD are

unknown, the study investigators sought to assess the proportion of patients who develop acute kidney injury, and to explore the risk factors.

Their primary aim was to assess the incidence of acute kidney injury after PTA. The primary outcome was therefore the proportion of patients who developed acute kidney injury after PTA, using the Kidney Disease Improving Global Outcomes (KDIGO) reporting criteria. Secondary outcomes were the proportion of patients who died, underwent a major amputation, required dialysis within 90 days of intervention, remained dialysisdependent after 90 days of intervention,

Introduction of dedicated vascular limb salvage clinic improves one-year amputation outcomes for CLTI patients One-year outcomes of patients with chronic-limb threatening ischaemia (CLTI) treated in an outpatient-based vascular limb salvage clinic show an improved rate of major amputation. Authors Andrew Nickinson (University of Leicester, Leicester, UK) and colleagues write in an online European Journal of Vascular and Endovascular Surgery (EJVES) article that their study supports the recommendations of the Global Vascular Guidelines and “provides a reproducible service model that delivers timely vascular assessment in an ambulatory setting”.

Acute kidney injury developed in 239 patients (11.7%), with 47 (2.3%) requiring dialysis within 30 days, and 18 (0.9%) requiring ongoing dialysis

or developed the major adverse kidney events (MAKE) endpoints—death, dialysis, and/or drop in estimated glomerular filtration rate of at least 25%—at 30 or 90 days (MAKE30 and MAKE90, respectively).

Katsogridakis et al prospectively collected and analysed data on 2,041 patients undergoing femoropopliteal endovascular intervention for symptomatic PAD (Rutherford stages III–VI) between 2014 and 2019 across three vascular centres.

Acute kidney injury developed in 239 patients (11.7%), with 47 (2.3%)

Efforts in the prevention of this complex and important complication of endovascular therapy, addressing high-risk groups, are a priority.”

WHILE VASCULAR LIMB SALVAGE services are recommended by the Global Vascular Guidelines to help improve outcomes for patients with CLTI, the authors write that literature on the topic is limited. It was the aim of this study, therefore, to provide data on the effect of treating CLTI patients in an outpatient-based vascular limb salvage clinic on amputation outcomes.

The George Davies Research Group, based at the University of Leicester, undertook an analysis of a prospectively-maintained database, involving all consecutive patients diagnosed with CLTI within the Leicester Vascular Limb Salvage (VaLS) clinic from February 2018 to February 2019.

They compared data with two comparator cohorts, identified from coding data: 1) patients managed prior to the clinic, between May 2017 and February 2018 (Pre-Clinic [PC]); and 2) patients managed outside of clinic, between February 2018 and February 2018 (Alternative Pathways [AP]). Freedom from major amputation at 12 months was the primary outcome.

Writing in EJVES, Nickinson et al detail that 566 patients were included (median age 74 years) in the study. They report that patients managed within the VaLS cohort were statistically significantly more likely to be free from major amputation (90.5%) compared with both the AP (82.1%; adjusted hazard ratio [aHR] 0.52; 95% confidence interval [CI]

requiring dialysis within 30 days, and 18 (0.9%) requiring ongoing dialysis.

The MAKE30 and MAKE90 composite endpoints were reached in 358 (17.5%) and 449 (22%) patients respectively.

Risk factors for acute kidney injury were age, sex, congestive heart failure, chronic limb-threatening ischaemia, emergency procedure, and pre-existing chronic kidney disease.

Acute kidney injury, dementia, congestive heart failure, and major amputation were risk factors for medium-term mortality, the authors report.

Commenting on these findings, Katsogridakis and colleagues note: “The acute kidney injury-specific risk factors identified in this series are mostly non-modifiable. Older age, male sex, history of congestive heart failure, CLTI [chronic limb-threatening ischaemia], and preoperative renal function have all been associated with acute kidney injury development previously in a variety of clinical settings, and were strongly associated with acute kidney injury in this study. It is not surprising that these parameters are associated with acute kidney injury in patients with severe PAD. Alongside these findings, the absence of correlation between contrast volume and subsequent acute kidney injury in this series further confirms that acute kidney injury encompasses a plethora of other pathophysiological mechanisms, including perioperative volume depletion, nephrotoxicity, and renal microembolisation.”

Looking to the future, the authors write: “Efforts in the prevention of this complex and important complication of endovascular therapy, addressing highrisk groups (elderly, men, CLTI, CKD, and heart failure), are a priority.”

0.28–0.98; p=0.041) and the PC (80%; aHR 0.5; 95% CI 0.28–0.91; p=0.022) cohorts at 12 months, after adjustment for age, disease severity, anti-platelets/lipid lowering therapies and presence of diabetes.

Following the publication of these results, Nickinson spoke to Vascular News about their significance: “We are really excited about the publication of these results in the EJVES, the culmination of a great deal of effect by the whole team in Leicester. Our sincere thanks go to George Davies Charitable Trust, whose generous donation has made the VaLS clinic a reality. Looking forward, a number of centres have now setup similar services across the UK and with the ongoing work of the Vascular Society’s PAD Quality Improvement Programme, it is great to see how interest is building across the UK in improving the outcomes for patients with CLTI.”

It is great to see how interest is building across the UK in improving the outcomes for patients with CLTI.”

April 2021 | Charing Cross Special Edition

Advertorial 29

THIS CASE REPORT IS SPONSORED BY BD

Case report: Complex endovascular treatment for an iliac artery occlusion using the LifeStream™ balloonexpandable vascular covered stent Martin Schroeder—a vascular surgery specialist at the Ruhr University Bochum Marienhospital Herne in Herne, Germany—has extensive clinical experience with the LifeStream™ balloon-expandable vascular covered stent (Bard). In this case report for Vascular News, he outlines the complex endovascular treatment of an iliac lesion.

Schroeder details that, at six-months follow-up, duplex ultrasound showed an “excellent result,” with open iliac vessels and without any discomfort or claudication symptoms.

A 70-YEAR-OLD WOMAN WITH KNOWN diffuse bronchial carcinoma, osseous and pulmonary metastasis, respiratory global insufficiency, arterial hypertension, and a smoking habit received left-side hip surgery for pathological fracture. Persistent pain in the leg appeared immediately after the operation. The patient was presented to our clinic after two days with the following symptoms: dyspnoea, sensory and motor deficit, lack of pulse, and pale ischaemic left leg.

Computed tomography (CT) angiography (Figure 1) showed thrombotic occlusion of the common and external and pre-existing occlusion of the internal iliac artery with diffuse atherosclerotic changes in the infrarenal aorta and bifurcation area with a pronounced, high-grade stenosis of the common iliac artery (TASC-D).

Due to the patient’s comorbidities, we decided to perform a percutaneous endovascular procedure using hydrodynamic aspiration to remove the thrombotic material and to demarcate the stenosis with additional stenting. An ultrasound-controlled retrograde puncture was performed in both groins.

A 6F sheath on the right side and an 8F sheath on the left side were inserted. The first angiography from the left side showed the occlusion of the iliac artery (Figure 2). In the first step, a 0.035-inch wire was introduced until the bifurcation on the left side, but it was impossible to cross the lesion. We then introduced the 8F aspiration device and administered lysis therapy using a ‘Hyperpulse’ application. After an exposure time of approximately 10 minutes, the hydrodynamic aspiration thrombectomy was carried out (Figure 3).

The extreme stenosis of the common iliac artery was then exposed, and it was possible to cross it with the 0.035-inch wire and a support catheter. Renewed

Figure 1: Preoperative CT angiography reconstruction, severely calcified aortoiliac arteries, left occlusion common and external iliac artery

Figure 2: Angiography shows the closure of the left side

A six-month followup duplex ultrasound showed an excellent result with open iliac vessels.”

Figure 3: 8F hydrodynamic aspiration device in action in the area of the common femoral artery

angiographic display and measurement of the iliac vessel diameter were taken (Figures 4 and 5). Based on the measurements and the anatomical conditions, the decision was made to use two LifeStream™ balloonexpandable vascular covered stents (Bard).1,2 The first covered stent, at 9x38mm, was released in the area of the bifurcation using the Kissing stent technique. An 8mm plain balloon was then placed on the contralateral side to avoid damage, such as thrombus material and the development of stenoses (Figure 6).

We completed the lesion coverage with a 7x38mm LifeStream™ balloon-expandable vascular covered stent (Bard) and performed a post-dilation in the area of the transition of both stents with 9x40mm percutaneous transluminal angioplasty (PTA) balloon. The final angiography showed excellent results, with good stent expansion and without remaining stenoses (Figure 7).

A percutaneous suture meditated closure system was used for femoral artery puncture site closure. On the right groin, the haemostasis was performed with a percutaneous closure device.

Outcomes and follow-up

The patient was discharged on the third postoperative day. A six-month follow-up duplex ultrasound showed an excellent result with open iliac vessels without any discomfort or claudication symptoms. The presented technique with hydrodynamic aspiration to demarcate the lesion and precise placement of the covered stents is a prerequisite for successful anatomical reconstruction in complex iliac lesions.

References 1. Laird JR, Zeller T, Holden A, et al. Balloon-expandable vascular covered stent in the treatment of iliac artery occlusive disease: Nine-month results from the BOLSTER multicenter study. J Vasc Interv Radiol. 2019;30(6):836– 844.e1. doi:10.1016/j.jvir.2018.12.031 2. Mwipatayi BP, Sharma S, Daneshmand A, et al. Durability of the balloonexpandable covered versus bare-metal stents in the Covered versus balloon expandable stent trial (COBEST) for the treatment of aortoiliac occlusive disease. J Vasc Surg. 2016;64(1):83–94.e1. doi:10.1016/j. jvs.2016.02.064

Figure 4: Measurement of the common Iliac vessel

Figure 5: Measurement of the Iliac common vessel

LifeStream™ balloon-expandable vascular covered stent (Bard)

Figure 6: Left side: 9x38mm LifeStream™ balloon-expandable vascular covered stent (Bard); right side: common iliac artery 7x40mm PTA balloon

Figure 7: Final angiography with 9x38mm and 7x37mm LifeStream™ balloon-expandable vascular covered stents (Bard) in the area of the left common iliac artery, without remaining stenoses

LIFESTREAM™ Balloon Expandable Vascular Covered Stent Prescriptive Information: Prior to use, please see the complete “Directions for Use” for information on indications, Contraindications, Warnings, Precautions, Adverse Events and Operator’s Instructions Indications: The LifeSteam™ Balloon Expandable Vascular Stent is indicated for the treatment of atherosclerotic lesions in common and external iliac arteries.

Contraindications: Use in patients with uncorrected bleeding disorders. Patients who cannot Recommend antiplatelet and/or anticoagulation therapy. Patients who are judged to have a lesion that prevents full expansion of the implant. Lesions in which the lumen diameter post balloon angioplasty is insufficient for the passage of the endovascular system. Lesions locations subject to external compression. Warnings: Stentings across a vessel side branch may impede blood flow and hinder or prevent, future procedures. Should excessive resistance be felt at any time during the insertion process, do not force passage. Do not attempt to remove an unexpanded covered stent through the sheath/guiding catheter. Remove the sheath/guiding catheter and endovascular system as a single unit. Attempting to remove unexpanded covered stent dislodgement. Do not exceed the maximum rated pressure since this increases the potential for balloon rupture and vessel damage. Precautions: Use caution when advancing the endovascular system through tortuous or difficult anatomy. This device has not been tested for use in overlapped conditions with stents or covered stent from other manufacturers.

Not available in the USA. Bard, Advancing Lives, and the Delivery of Health Care, and LifeStream and trademarks and/or registered trademarks of C.R Bard, Inc. Copyright © 2015, C. R Bard, Inc. All Rights Reserved. S120581 Rev. 1 CE 0344 BD Switzerland Sarl, Route de Crassier 17, Business Park Terre-Bonne, Batiment A4, 1262 Eysins Switzerland, Tel: +41 21 556 30 00. Fax: +41 44 722 5370

BD25428

Charing Cross Special Edition | April 2021

30 Journal updates

PERIPHERAL

Study: Patients with depression less likely to go home after critical limb revascularisation A recent analysis by finds an association between depression and non-home discharge after revascularisation for chronic limbthreatening ischaemia (CLTI). Authors Joel L Ramirez, James C Iannuzzi (University of California, San Francisco, San Francisco, USA) and colleagues write in an online Journal of Vascular Surgery (JVS) article that these results “provide further evidence of the negative impact that comorbid depression has on patients undergoing revascularisation for CLTI,” and propose that future studies should examine whether treating depression can improve outcomes in this patient population.

“RECENT EVIDENCE SUGGESTS that depression in patients with peripheral arterial disease (PAD) is associated with increased postoperative complications,” the authors begin, noting that problems can include decreased primary and secondary patency after revascularisation and increased risk of major amputation and mortality.

Ramirez et al note that the impact of depression on non-home discharge after vascular surgery remains unexplored, despite this being “an important outcome” for patients. They hypothesised that depression would be associated with an increased risk

for non-home discharge following revascularisation for CLTI. The investigators identified endovascular, open, and hybrid cases of revascularisation for CLTI from the 2012–2014 National (Nationwide) Inpatient Sample, which they explain is “a patient-level administrative claims database that is published annually by the Agency for Healthcare Research and Quality and represents approximately 20% of discharges from US hospitals”.

They write that a hierarchical multivariable binary logistic regression controlling for hospital level variation examined the association

between depression and nonunadjusted analyses, patients home discharge and controlled with depression had a 7% for confounders meeting absolute increased risk p<0.01 on bivariate analysis. of requiring non-hospital Ramirez and colleagues discharge (32.1% vs. 24.9%, identified 64,817 cases, of p<0.001). On multivariable which 5,472 (8.4%) were analysis, they found that diagnosed with depression, patients with depression had and 16,524 (25.5%) required an adjusted 50% increased James C Iannuzzi non-home discharge. odds for non-hospital They relay that patients discharge (odds ratio with depression were younger, more [OR]=1.5; 95% confidence interval likely to be women, white, have multiple [CI]=1.4–1.61; c-statistic, 0.81) comorbidities, a non-elective admission, compared to those without depression. and experience a postoperative After stratification by operative complication (p<0.05). approach, Ramirez et al identified The authors report that, on that depression had a larger effect estimate in endovascular revascularisation (OR=1.57; CI=1.42– 1.74) compared to open (OR=1.45; 95% CI=1.3–1.62).

Finally, the authors write in JVS that a test for interaction between depression and gender showed that men with depression had higher odds of non-hospital discharge compared to women with depression (OR=1.68; 95% CI=1.51–1.88 vs. OR=1.37; 95% CI=1.25–1.51; interaction p<0.01).

Ramirez and colleagues note that their investigation was limited by the fact that is was based on a large national administrative database, in which all diagnoses are determined based upon billing codes. They acknowledge that use of this particular source “may introduce bias and be susceptible to underreporting of certain comorbidities”.

These results provide further evidence that an increased awareness about mental health is fundamental to care for vascular surgery patients and to understand postoperative pathways.”

Use of wearable activity monitors could benefit intermittent claudication patients, study suggests

There is some evidence to indicate that the inclusion of wearable activity monitors in home-based exercise therapy improves walking ability and quality of life in patients with intermittent claudication. This is the main finding of a systematic review that recently appeared online in the European Journal of Vascular and Endovascular Surgery (EJVES).

D

espite the fact that supervised exercise therapy is the recommended first-line management for intermittent claudication, authors Calvin Chan (Imperial College London, London, UK) and colleagues write that its uptake is “often limited by accessibility, compliance, and cost”.

As a result, they state that there has been an increased interest in the use of wearable activity monitors in home-based telemonitoring exercise programmes for claudicants. Considering what differentiates wearable activity monitors from traditional methods of tracking activity, i.e. a selfreported activity log, the authors write that wearables “allow accurate, autonomous long-term tracking and quantification of physical activity,” for example, daily steps, walking distance, and heart rate.

In their review, Chan et al aimed to evaluate the efficacy of wearable activity monitors as a feedback and monitoring tool in home-based exercise programmes for patients with intermittent claudication.

The investigators searched the MEDLINE, EMBASE, and Web of Science databases through to April 2020. They included randomised and prospective trials, which had to incorporate wearable activity monitors as a feedback

tool to target walking/exercise behaviour. The primary outcome was change in walking ability, measured by maximum walking distance, claudication distance, and six-minute walking distance.

Chan and colleagues report that 1,148 records were retrieved, including eight randomised controlled trials and one prospective cohort study that met the inclusion criteria. The authors note that, due to heterogeneity between the studies, they could not conduct a meta-analysis.

Writing in EJVES, the authors relay that wearable activity monitor interventions improved measures of walking ability, increased daily walking activity, the cardiovascular metric of maximum oxygen consumption, and quality of life.

In the discussion of their findings, the authors also address a cost element. They note that, although cost-effectiveness was not evaluated in this review, wearable activity monitor interventions “may be a more economically accessible option compared to supervised exercise therapy”. In addition to patient travel time and costs, they write, a threemonth supervised exercise therapy programme is estimated to cost between £235–345 per patient and requires specialist staff, equipment, and room hire.

In comparison, an accurate tri-axial accelerometer

wearable activity monitor can cost as little as £21, they report.

“Long-term functional outcomes of home-based wearable activity monitor interventions need to be investigated”

While Chan and colleagues conclude that this is “some evidence” to support home-based wearable activity monitor interventions are beneficial for improving outcomes for patients with intermittent claudication, they stress that existing studies are limited by inadequate sample size, duration, and appropriate power.

Going in to more detail about these limitations, they acknowledge that the overall risk of bias was “variable” amongst included studies. “Several deficiencies noted in the risk of bias assessment in three out of nine studies may temper the findings of this review,” they communicate in EJVES. In addition, Chan et al recognise that a lack of standardised testing methods and reporting outcomes for exercise interventions in the included studies limited the strength of their conclusions.

Focusing on time scale, they note that current evidence is limited in this regard. “Long-term functional outcomes of home-based wearable activity monitor interventions need to be investigated to ascertain the impact of ongoing coaching and sustainability,” they suggest.

Finally, the authors recognise that wearable activity monitor adherence, as well as the lack of adherence reporting, was a limitation. Regarding adherence, Chan and colleagues note that low compliance to wearable activity monitors “may be confounded by lack of digital literacy,” noting that PAD [peripheral arterial disease] primarily manifests in older patients, “who have the lowest rates of smartphone adoption and digital literacy”.

Charing Cross Special Edition | April 2021

32 Asymptomatic carotid disease

CAROTID

New data find strong association between asymptomatic carotid stenosis and future stroke risk Reporting a strong association between asymptomatic carotid stenosis and future stroke risk, Dominic Howard (Oxford University Hospitals NHS Trust, Oxford, UK) and colleagues write in The Lancet Neurology that their findings are “contrary to the assumptions of current guidelines and the findings of subgroup analyses of previous randomised controlled trials”.

T

he research group’s population-based cohort study, systematic review, and metaanalysis found reported stroke risk to be “highly dependent” on the degree of asymptomatic carotid stenosis, suggesting that the benefit of endarterectomy “might be underestimated in patients with severe stenosis”. Conversely, the investigators disclose that the five-year stroke risk was low for patients with moderate stenosis on contemporary medical treatment, “calling into question any benefit from revascularisation”.

“There is uncertainty around which patients with asymptomatic carotid stenosis should be offered surgical intervention,” Howard et al begin. They note that stroke rates were unrelated to the degree of stenosis in the medical-treatment-only groups in previous randomised trials, but suggest that “this could simply reflect recruitment bias”. In addition, they stress that there has been no systematic analysis of a stenosisrisk association in cohort studies.

In the present study, the investigators aimed to establish whether there is any association between the degree of asymptomatic stenosis and ipsilateral stroke risk in patients on contemporary medical treatment.

Howard and colleagues performed a prospective population-based study—the Oxford Vascular study (OxVasc)—as well as a systematic review and meta-analysis. “All patients in OxVasc with a recent

suspected transient ischaemic attack or stroke, between 1 April 2002 and 1 April 2017, who had asymptomatic carotid stenosis were included in these analyses,” they detail.

The investigators commenced Dominic Howard contemporary medical treatment and determined ipsilateral stroke risk in the cohort by face-to-face follow-up (to 1 October 2020) and also performed a systematic review and meta-analysis of all published studies (from 1 January 1980 to 1 October 2020) reporting ipsilateral stroke risk in patients with asymptomatic carotid stenosis. They searched MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials, and included both observational cohort studies and medical treatment groups of randomised controlled trials (RCTs) if the number of patients exceeded 30, ipsilateral stroke rates (or the raw data to calculate these) were provided, and were published in English.

provided data on ipsilateral stroke risk fully stratified by degree of asymptomatic stenosis (in 8,419 patients).

Howard and colleagues relay that stroke risk was linearly associated with degree of ipsilateral stenosis (p<0.0001); there was a higher risk in patients with 70–99% stenosis than in those with 50–69% stenosis (386 of 3,778 patients vs. 181 of 3,806 patients; odds ratio [OR] 2.1 [95% CI 1.7–2.5], p<0.0001; 15 cohort studies, three trials) and a higher risk in patients with 80–99% stenosis than in those with 50–79% stenosis (77 of 727 patients vs. 167 vs. 3,272 patients; OR 2.5 [1.8–3.5]; p<0.0001; 11 cohort studies).

Finally, the authors communicate that heterogeneity in stroke risk between studies for patients with severe versus moderate stenosis (Phet<0.0001) was accounted for by highly discrepant results (Pdiff<0.0001) in the randomised controlled trials of endarterectomy compared with cohort studies (trials: pooled OR 0.8 [95% CI 0.6–1.2], Phet=0.89; cohorts: 2.9 [2.3–3.7], Phet=0.54).

2,354 2,178

While the present results differ from those of previous RCTs, Howard and colleagues remark on the potential drawbacks of this study type. Despite RCTs being the “gold standard” for quantifying the effects of an intervention, they are “nonetheless prone to selection biases when determining risk associations within treatment groups,” the authors write. They suggest that guidelines should consider this issue when setting criteria for selecting patients for an intervention.

Howard et al conclude: “Despite advances in medical therapy, the stroke risk for patients with highgrade asymptomatic carotid stenosis remains high, suggesting that the benefit of the surgical intervention might be underestimated in current guidelines.

“Conversely, up to five years of follow-up data from patients on contemporary medical therapy for moderate stenosis suggest that stroke risk is low in this population, calling into question any benefit from revascularisation.”

Between 1 April 2002 and 1 April 2017, 2,354 patients were consecutively enrolled in the study and 2,178 patients underwent carotid imaging Five-year ipsilateral stroke risk increased with the degree of stenosis

Within the 15-year OxVasc timeframe, 2,354 patients were consecutively enrolled in the study and 2,178 patients underwent carotid imaging, of whom 207 had 50–99% asymptomatic stenosis of at least one carotid bifurcation (mean age at imaging: 77.5 years; 88 (43%) women).

Writing in The Lancet Neurology, Howard et al report that the five-year ipsilateral stroke risk increased with the degree of stenosis. They elaborate that patients with 70–99% stenosis had a significantly greater fiveyear ipsilateral stroke risk than did those with 50–69% stenosis—six (14.6%; 95% confidence interval [CI] 3.5–25.7) of 53 patients vs. none of 154; p<0.0001.

Furthermore, patients with 80–99% stenosis had a significantly greater five-year ipsilateral stroke risk than did those with 50–79% stenosis—five (18.3%; 7.7–29.9) of 34 patients vs. one (1%; 0–2.9) of 173; p<0.0001.

Of the 56 studies identified in the systematic review (comprising 13,717 patients), the authors note that 23

USPSTF recommends against general screening for asymptomatic carotid artery stenosis In a recommendation statement published on 2 February in The Journal of the American Medical Association (JAMA), the US Preventive Services Task Force (USPSTF) advises against screening for asymptomatic carotid artery stenosis in the general adult population. This recommendation is consistent with the task force’s 2014 statement on the topic.

DURING A REVIEW OF ALL the available data on screening for carotid artery stenosis in the general population, authors Alex H Krist (Virginia Commonwealth University, Richmond, USA) and colleagues detail that the USPSTF “found no new substantial evidence” that could change its 2014 recommendation. Therefore,

the statement concludes “with moderate certainty that the harms of screening for asymptomatic carotid artery stenosis outweigh the benefits”.

The authors detail that asymptomatic carotid artery stenosis refers to stenosis in persons without a history of ischaemic stroke, transient ischaemic attack, or other neurologic symptoms referable to

Benefit of surgical intervention “might be underestimated in current guidelines”

There is uncertainty around which patients with asymptomatic carotid stenosis should be offered surgical intervention.”

the carotid arteries.

The prevalence of asymptomatic carotid artery stenosis is low in the general population but increases with age, Krist et al note, adding that, while asymptomatic carotid artery stenosis is a risk factor for stroke and a marker for increased risk for myocardial infarction, it causes a relatively small proportion of strokes.

Although the USPSTF do not recommend screening of the general population for asymptomatic carotid artery stenosis, the authors acknowledge that several risk factors increase a person’s risk, including older age, male sex, hypertension, smoking, hypercholesterolaemia, diabetes, and heart disease. However, they also state that “there are no externally validated, reliable methods to determine who is at increased risk for carotid artery stenosis,

or who is at increased risk for stroke when carotid artery stenosis is present”.

Krist and colleagues write: “More research is needed to evaluate the benefits and harms of screening for asymptomatic carotid artery stenosis in the general adult population.”

They suggest that future research would include trials with long-term follow-up (>5 years) that compare carotid endarterectomy (CEA) or carotid artery angioplasty and stenting (CAS) plus contemporary best medical therapy with best medical therapy alone, including completion of ongoing trials.

In addition, they recommend the development and validation of tools to determine which persons are at high risk for carotid artery stenosis and for stroke due to carotid artery stenosis and who might experience harm from treatment with CEA or CAS.

Charing Cross Special Edition | April 2021

34 Advertorial THIS ADVERTORIAL IS SPONSORED BY CRYOLIFE

100th patient treated with JOTEC E-liac Stent Graft System in PLIANT II study at the VUmc Amsterdam Within the scope of the PLIANT II study, the 100th patient was treated with the E-liac Stent Graft System on 4 December 2020. The implantation was performed at the University Medical Center VUmc in Amsterdam, The Netherlands.

T

he E-liac Stent Graft System is an iliac branch device (IBD) indicated for the endovascular treatment of patients with uni- or bilateral, aortoiliac or isolated iliac aneurysms (Figure 1). It is deployed from an 18 French delivery system via a stepwise squeeze-to-release mechanism. The stent graft represents one of three IBDs available on the European market and the only device approved for treatment of isolated iliac artery aneurysms without concomitant abdominal aortic aneurysm (AAA).

Technically, the E-liac Stent Graft System consists of self-expanding nitinol stents covered with woven polyester. The iliac side branch features an asymmetric spring configuration that optimises three-dimensional conformability to the iliac arteries. It is supposed to be bridged into the internal iliac artery using a peripheral covered stent. X-ray markers indicate the overlapping zone for the bridging stent in the side branch as well as the proximal and distal ends of the polyester cover.

A JOTEC-specific E-marker at the offspring of the side branch facilitates its orientation and cannulation into the internal iliac artery. Safety and efficacy of the device have been evaluated in the observational, prospective multicentre PLIANT study, which has already shown that the E-liac Stent Graft System is efficient in excluding common iliac artery aneurysms both when isolated and in combination with an aortic aneurysm and preventing aneurysm rupture in the midterm. Long-term clinical data on the device are being collected under widespread use in a patient population with iliac aneurysms within the scope of the PLIANT II study.

included patients will be examined at discharge or 30 days as well as at 12, 24, 36, and 60 months after the intervention. The primary endpoint is freedom from type I and III endoleak and patency of external and internal iliac arteries on E-liac implantation side(s) at 12 months of follow-up. Since May 2018, 29 clinical centres in eight European countries have been initiated in the study and further sites will follow to enrol a total of 400–500 patients. Prior to data collection, all patients participating in the study are informed of its nature and purpose and express their written informed

consent to the use of their clinical records. The data of 60% of randomly selected patients are monitored against the data entered in site source documents at each time point of follow-up to ensure a high degree of data quality as well as compliance with pertinent regulatory requirements. Further information on the study is available under ClinicalTrials.gov, Identifier: NCT03606083.

“Great opportunity” to gather long-term data on the E-liac Stent Graft System

Jan Brunkwall, the former chief physician of the Department of Vascular and Endovascular Surgery of the University Clinics of Cologne (Cologne, Germany) and principal coordinating investigator of the study, stated: “It is of utmost importance to have a significant number of patients being surveyed and followed for a long period of time, as most complications of the iliac side branch technology appear later than three years after implantation. The PLIANT II registry is a great opportunity to gather such long-term performance data on the E-liac Stent Graft System that will add to our experience with this specific device as well as with iliac branch devices in general.”

The 100th implantation in the PLIANT II study was performed by Vincent Jongkind in close collaboration with Kak Khee Yeung, Hillian Nederhoed, Tara van Merrienboer, and Arjan Hoksbergen, who is the Dutch co-principal investigator of the study (Figure 2). The

Key features of the PLIANT II study

The PLIANT II study is an observational, prospective multicentre registry sponsored by the German medical device manufacturer JOTEC/CryoLife. It represents a non-interventional observation in routine care in the sense of postmarket clinical follow-up.

The investigator protocol has been submitted to all applicable ethical committees for approval. The study objective is to examine the real-world outcomes of consecutive patients with uni- or bilateral aortoiliac or iliac aneurysms after treatment with the E-liac Stent Graft System. Inclusion criteria encompass age between 18 and 85 years, an aortoiliac or iliac aneurysm (uni- or bilateral), anatomy suitable for stent graft placement, availability for the appropriate follow-up time points, and a signed informed consent form prior to intervention. Not eligible to the PLIANT II study are patients who are of child-bearing potential, who present with aneurysms that are ruptured or at a different body site, who are pretreated with devices unsuitable to be combined with an E-liac Stent Graft System, who participate in another clinical study, who undergo chemo- or radiation therapy, who have a life expectancy of less than three years, or are minors. All

Figure 1. L-R: The E-liac Stent Graft System and the E-tegra Stent Graft System

It is of utmost importance to have a significant number of patients being surveyed and followed for a long period of time.”

– Jan Brunkwall

patient was a 74-year-old male who had undergone open surgery for an abdominal tube graft a few years ago. He developed a right common iliac artery aneurysm of 55mm in diameter and additionally a left femoral artery aneurysm of 56mm in diameter. The aneurysmal femoral artery was replaced by a JOTEC FlowNit BIOSEAL polyester graft before the E-liac stent graft and the abdominal E-tegra stent graft were implanted during an endovascular procedure to exclude the iliac aneurysm. Placement of an abdominal aortic stent graft was necessary to create a proximal sealing zone for the IBD as the whole common iliac artery was

April 2021 | Charing Cross Special Edition

Advertorial 35

Figure 3. L-R: Bram van der Meijs, Arjan Hoksbergen, Jan Blankensteijn, Tara van Merrienboer, Willem Wisselink, Rutger Lelij, Kak Khee Yeung, Vincent Jongkind, and Hillian Nederhoed

Placement of the E-liac stent graft is very intuitive. Further advantages are good visibility of the markers and the possibility of accurate deployment using the squeeze-torelease mechanism.”

– Vincent Jongkind Balloon Catheter. Angiographic imaging confirmed that the implantation of the E-liac and E-tegra Stent Graft Systems had been successful (Figure 2).

Looking ahead: First results expected in 2024

Figure 2. L-R: Final angiography from the case; onemonth follow-up computed tomography (CT) image

dilated and insufficient as sealing zone. In a first step of the procedure, the E-liac stent graft was introduced via the right femoral artery to align the side branch 10mm above the ostium of the internal iliac artery.

The JOTEC E-ventus BX balloon-expandable peripheral stent graft was placed via the left side in a cross-over manoeuvre, bridging the E-liac side branch into the internal iliac artery. Subsequently, an E-tegra main body prosthesis was introduced via the left side and deployed within the surgical graft.

The contralateral leg of the main body was extended into the left common iliac artery. Finally, in order to connect the E-tegra main body with the E-liac Stent Graft System, an E-tegra iliac extension limb was deployed between the ipsilateral leg of the abdominal main body and the proximal part of the E-liac Stent Graft System to exclude the aneurysm. Afterwards, the whole stent graft system was modelled to the vessel walls using the JOTEC E-xpand Stent Graft

“The procedure went smoothly,” Jongkind remarked.

“Placement of the E-liac Stent Graft System is very intuitive. Further advantages are good visibility of the markers and the possibility of accurate deployment using the squeeze-to-release mechanism.”

Control imaging during the one-month follow-up appointment verified that the patient did not develop any endoleaks and that the E-liac Stent Graft System was well in place. The PLIANT II study is estimated to be completed in October 2028. First results will be published as soon as all patients will have reached their 12-month follow-up, which is expected in the second half of 2024.

Charing Cross Special Edition | April 2021

36 IVUS in venous procedures

VENOUS

IVUS should be considered “essential equipment” in venous interventions, LINC 2021 viewers hear “I consider intravascular ultrasound (IVUS) to be essential equipment in venous interventions,” Rick de Graaf (Clinic of Friedrichshafen, Friedrichshafen, Germany) told viewers of LINC 2021 (The Leipzig Interventional Course; 25–29 January, online).

De Graaf was speaking during a session on endovascular procedures for the deep venous system, aiming to answer the question: Is IVUS a fancy tool, or relevant for clinical outcomes?

“I

t is hard to say that [IVUS] is fancy,” de Graaf began, noting that this is technology is essentially “just an ultrasound probe on a catheter”. In venous interventions, he noted, the technology is mainly used to indicate stenosis, determine a healthy stent landing zone, to evaluate after stenting, and evaluate after thrombectomy to see if there is any residual thrombus.

Regarding data, de Graaf detailed that there are a number of papers on using IVUS for diagnosis and procedural planning, as well as recent data from the

Arnsberg registry, headed by Michael Lichtenberg (Karolinen Hospital, Arnsberg, Germany), that showed IVUS to be an effective option to reduce radiation during deep venous obstruction (DVO) interventions. Indeed, Lichtenberg told Venous News at LINC 2020 (28–31 January, Leipzig, Germany) that IVUS helps to reduce radiation exposure “significantly” for patients undergoing venous stenting.

De Graaf then summarised the benefits of IVUS in venous procedures, detailing that the technology can identify “subtle yet significant” pathology—even more

so than magnetic resonance IVUS when they need it, but (MR)-venography, in his likened this to only wearing a view—gives “instant and seatbelt when it is needed. accurate” three-dimensional In terms of experience, de (3D) representation, reduces Graaf detailed that he started radiation, as different performing venous procedures angulations are not necessary in 2009 without IVUS, due to and the imaging is more the cost. However, he became efficient, and reduces contrast. Rick de Graaf convinced of its importance Moving on to when and after several stent occlusions how to use IVUS in venous practice, de proved to be related to the lack of IVUS. Graaf expressed his belief that to not use “I now use IVUS in every venous case,” it at all would be “dangerously close to he reiterated. malpractice”. He elaborated: “Sooner or later you are going to miss something, Case report: IVUS leads to and the patient will suffer.” successful thrombus removal De Graaf told the audience that he De Graaf outlined a specific venous case has IVUS present in all venous cases, in which IVUS was crucial. A patient because “you never know what you are presented with iliac vein thrombosis, going to miss,” he said. De Graaf noted but also a distal vena cava thrombosis, that some physicians state they only use he explained. While the speaker noted that he cleared out the iliac vein and stented it, IVUS then showed that there was still thrombus in the inferior vena cava (IVC), which could not be left. “I tried thrombectomy and suction with a large sheath, but I did not get it out,” he relayed. De Graaf then decided to use live imaging with IVUS and was able to remove the thrombus successfully under IVUS guidance.

“IVUS obviously has significant value guiding venous interventions, and realtime IVUS offers further possibilities,” de Graaf concluded.

IVUS obviously has significant value guiding venous interventions, and real-time IVUS offers further possibilities.”

Meta-analysis: IVC filters should be considered for certain patients at high risk of PE In a recent meta-analysis, Yang Liu, Huan Lu (Henan Cancer Hospital, Zhengzhou, China), and colleagues found insufficient evidence to prove that inferior vena cava (IVC) filters can reduce pulmonary embolism (PE)-related mortality and overall mortality.

However, they did find that IVC filters decrease the occurrence of PE without increasing deep venous thromboembolism (DVT) and major bleeding. Therefore, they conclude: “IVC filters should be considered after balancing the benefits and risks for the patients with contraindications to anticoagulant therapy of high risk for PE.” WRITING IN THE JOURNAL OF VASCULAR Surgery: Venous and Lymphatic Disorders, Liu, Lu, et al outline the scale of the issue at the core of their analysis: “Venous thromboembolism (VTE), which mainly presents as DVT and PE, is an important and potentially fatal disease with a high incidence and causes a huge burden.”

Considering treatment options, they write that, besides anticoagulation, the application of IVC filters is “commonly used” in patients with contraindications to anticoagulation therapy—for example, those who have been injured or who are at high risk of bleeding—or patients with a high risk of embolism occurrence. “However,” they write, “there is no clear consensus on the benefits and risks of IVCs from randomised controlled trials (RCTs)”.

Liu, Lu, and colleagues elaborate: “Systematic reviews have shown that IVC filters appear to reduce the incidence of subsequent PE, while appearing to increase the chance of DVT, and they have a limited effect on overall mortality. However, data in half of the included trials were not pooled into the effect size (odds ratio), which weakens the evidence of the

conclusion.” Due to this lack of clarity on the subject, the researchers performed a systematic review and meta-analysis of RCTs with “more appropriate effect measures and more trials” in order to investigate the effect of IVC filters on PE-related mortality and complications.

The team searched PubMed and Cochrane libraries from inception to 31 October 2019 to identify RCTs for their meta-analysis. They detail that the primary outcome was mortality related to PE; secondary outcomes were overall mortality, occurrence of PE, DVT, and major bleeding.

Overall, the investigators included seven articles, comprising 1,274 patients, in their meta-analysis.

They report that there was no significant difference in mortality related to PE between the IVC filter groups and the control group within three months (risk difference, -0.01; 95% confidence interval [CI], -0.03–0; p=0.11) and during the whole follow-up time with low heterogeneity (I2=0%).

However, they relay that the rates of new occurrence of PE within three months and during the whole follow-up period were lower in the IVC filter

group than those in the control group (0.81% vs.

5.98%; risk ratio, 0.17; 95% CI, 0.04–0.65; p=0.01; 3.2% vs. 7.79%; risk ratio, 0.42; 95% CI, 0.25–0.71; p=0.0001, respectively).

Finally, Liu, Lu, et al communicate that there were no significant differences in the rates of new occurrence of DVT, major bleeding, and mortality rates during the whole follow-up period between the groups (p>0.05).

Large RCTs needed “to provide more robust evidence”

The authors acknowledge some limitations of the present study. They recognise, for example, that patients who were recruited in the included trials were “not completely consistent” regarding disease conditions and that performing subgroup analyses was limited because of the paucity of trials. Finally, they state that performance bias was a high risk, which was attributed to the “dramatic difference” in therapy between the two groups. “This made participants and personnel blinding from the intervention strategy impossible, and might have affected the outcomes to a certain extent,” they remark.

Looking forward, Liu, Lu, and colleagues suggest that large RCTs are required “to provide more robust evidence”.

There is no clear consensus on the benefits and risks of IVCs from randomised controlled trials.”

Charing Cross Special Edition | April 2021

38 Market watch

Product News

IN.PACT AV DCB

Medtronic launches IN.PACT AV DCB in Japan for patients undergoing haemodialysis

Medtronic has announced the launch of IN.PACT AV drug-coated balloon (DCB) in Japan. IN.PACT AV DCB is indicated for the treatment of obstructive lesions up to 100mm in length in the native arteriovenous (AV) dialysis fistulae in patients with end-stage renal disease (ESRD) undergoing haemodialysis. It is the first DCB to be approved in Japan for this vessel bed.

In Japan, IN.PACT AV DCB received regulatory approval on 23 September 2020 and it became eligible for health insurance reimbursement on 1 February 2021.

According to a press release, IN.PACT AV DCB has the potential to maintain AV access site patency, which can extend the time between reinterventions, therefore maximising a patient’s uninterrupted access to dialysis care has been needed.

In a global clinical trial, patients treated with IN.PACT AV DCB maintained target lesion primary patency longer and required 56% fewer reinterventions to maintain target lesion patency as compared to those treated with standard percutaneous transluminal angioplasty (PTA) through six months.

FDA grants breakthrough device designation for Zenith fenestrated+ endovascular graft

The Zenith fenestrated+ endovascular graft (ZFEN+) product (Cook Medical) has received breakthrough device designation from the US Food and Drug Administration (FDA). This designation is granted for devices that have the potential to provide more effective treatment or diagnosis for lifethreatening or irreversibly debilitating diseases or conditions.

While the product is not commercially available yet, it will now receive priority review, and Cook will engage in “interactive and timely communication” with the FDA during the clinical trial and premarket review phases. The ZFEN+ is the first product from Cook Medical to receive a breakthrough device designation.

The product is intended for use in the endovascular treatment of patients with aortic aneurysms for whom the graft seal zone requires fenestrations and involves one or more of the major visceral vessels: celiac artery, superior

mesenteric artery, and/or renal arteries.

The ZFEN+ includes up to five fenestrations to accommodate the visceral vessels. Cook say in a press release that this extra customisation allows the graft “to be tailored to the patient’s unique anatomy and maximise the seal zone to exclude the aneurysm”.

Cook is seeking investigational device exemption (IDE) approval in the coming months with the intention of beginning a pivotal clinical study later this year.

FDA advisory panel recommends against premarket approval of Lutonix 014 DCB for BTK use

A US Food and Drug Administration (FDA) advisory panel has recommended against premarket approval of BD’s Lutonix 014 drug-coated balloon (DCB) for use in below-the-knee (BTK) arteries. In a meeting on 17 February, the majority of the FDA Cardiovascular Devices Panel concluded that the device was likely safe in BTK arteries, but not effective. The benefit-risk ratio also did not appear favourable for the Lutonix 014 DCB, it claimed.

Prior to the meeting, the FDA released an Executive Summary of the premarket approval application for the Lutonix 014 for the treatment of patients with critical limb ischaemia (CLI) who have obstructive de novo or

Lutonix 014 DCB

non-stented restenotic lesions in native popliteal, tibial, and peroneal arteries up to 320mm in length and 2–4mm in diameter.

In the document, they detail results of the Lutonix BTK investigational device exemption (IDE) pivotal study on which they based their conclusions.

This was a prospective, multicentre, 2:1 randomised controlled trial comparing the Lutonix 014 DCB (test group) to percutaneous transluminal angioplasty (control group) for the treatment of BTK arteries. The study was terminated after enrolling 507 of the prespecified 840 vessels.

The FDA summarised the outcomes of the study: “The Lutonix 014 DCB met the non-inferiority primary safety endpoint at 30 days. The primary effectiveness endpoint results did not reach statistical significance, although a 10.5% improvement was noted at six months. However, a durable benefit was not seen at later timepoints, with the KM [Kaplan-Meier] curves converging at 12 months and primary effectiveness

event rates favouring the PTA group thereafter.”

Looking in more detail at the benefits and risks, the FDA has not found any safety concerns with this device for this indication from the data provided: “To date, the FDA has not noted any safety concerns associated with the use of the Lutonix 014 DCB that would be expected to exceed those of current standard of care with non-drug containing devices. While a safety signal for increased mortality was noted for the use of paclitaxel-coated devices in the superficial femoral artery, this trend was not evidenced in the current study in the BTK anatomy.”

However, they express concern regarding effectiveness: “A modest benefit in regard to the primary effectiveness endpoint compared to PTA can be seen at six months, but a reversed outcome was noted at 12 months and beyond. Both prespecified and post hoc secondary endpoint effectiveness evaluations did not demonstrate a clear benefit of the Lutonix 014 DCB versus PTA.” “Overall, the study was terminated early and did not meet the prespecified hypothesis test success criteria.

It remains unclear whether the effectiveness differences at six months are clinically meaningful, and that the benefits of the paclitaxel-coated Lutonix DCB outweigh the risks compared to treatment with an uncoated balloon for treatment of atherosclerotic lesions below the knee,” they conclude.

HydroMID midline catheter from Access Vascular receives FDA clearance

Access Vascular has announced US Food and Drug Administration (FDA) clearance of its HydroMID midline catheter.

A press release from the company states that HydroMID, which is made of Access Vascular’s proprietary biomaterial that has been shown to reduce thrombus accumulation by up to 97% when compared to standard polyurethane catheters, is the second device in its planned portfolio to obtain clearance.

Midline catheters have grown in popularity due to inclusion in the MAGIC (Michigan appropriateness guide to intravenous catheters) guidelines, and the elimination of the need for confirmatory chest X-rays for midline placement. Standard midlines are composed of polyurethanes or silicones, which may lead to protein adsorption. This can result in thrombus accumulation or catheter-related infections.

HydroMID is a 4 French, singlelumen, midline catheter with a maximum usable length of 20cm. The midline catheter is due to be made available over the next few weeks to

HydroMID midline catheter

gain clinical feedback on its usage.

The company’s expansion into midlines enables healthcare professionals to choose either a midline or peripherally inserted central catheter made of this novel, thrombus-resistant biomaterial, depending on their needs.

Midlines, intended for use of up to 30 days, have the advantage of a generally higher level of patient comfort when compared to peripheral intravenous catheters (IVs) due to a fewer number of restarts.

The release of the midline also furthers the company’s plans to develop a portfolio of thrombus-resistant venous catheters and devices composed of its proprietary biomaterial to address the US$4.4 billion venous access market. The company’s first product— HydroPICC—was FDA-cleared last year and is currently rolling out commercially in the USA with the focus of obtaining real-world clinical data.

“FDA clearance for our second device demonstrates our commitment to a full product portfolio of venous access solutions and our commitment to help clinicians address the thrombus accumulation and catheter occlusion complications plaguing patients,” said Access Vascular CEO James Biggins.

“I am proud of our entire team for securing clearance. We look forward to working with clinicians to integrate our devices into their workflow and better understand the benefits that we can bring to patient treatment and care.”

Medtronic announces voluntary recall of unused Valiant Navion thoracic stent graft system

Medtronic has voluntarily issued a global recall of its Valiant Navion thoracic stent graft system and informed physicians to immediately cease use of the device until further notice.

In accordance with its commitment to patient safety—and in consultation with independent physicians—Medtronic initiated this action in response to information recently obtained from the Valiant Evo Global clinical trial indicating that three patients in the trial were observed to have stent fractures, two of which have confirmed type IIIb endoleaks. One patient death was reported.

An independent imaging laboratory reviewed all available images from patients enrolled in the Valiant Evo Global clinical trial. Upon further analysis of the images, seven out of 87 patients were observed to have stent ring enlargement beyond the design specification. Those observations require further assessment to determine potential clinical importance.

Medtronic is currently conducting a comprehensive technical root cause investigation, including further review of follow-up clinical trial imaging and commercial complaints and imaging.

The company has contacted the US Food and Drug Administration (FDA), along with other regulatory bodies around the world, to share information related to this issue.

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Charing Cross Special Edition | April 2021

40 Market watch

at LINC 2021

Clinical News Study finds hospital availability of TCAR associated with an improvement in overall outcomes for carotid revascularisation

Positive results from a comparativeeffectiveness study involving transcarotid artery revascularisation (TCAR) have been published in JAMA Network Open, Silk Road Medical have announced.

The study found the availability of TCAR at a hospital was associated with a significant decrease in the likelihood of major adverse cardiovascular events (MACE), a composite of inhospital stroke, myocardial infarction, or death at 30 days after carotid revascularisation, whether TCAR or carotid endarterectomy (CEA).

“Our results demonstrate that VQI [Vascular Quality Initiative] centres who offer TCAR achieve lower rates of adverse events after carotid surgery when compared to centres who do not offer the new procedure,” said lead author Jesse Columbo (DartmouthHitchcock Medical Center, Lebanon, USA). “We believe this indicates that centres that offer TCAR are able to better align patients with the best procedure for their individual clinical and anatomic characteristics.”

The analysis studied 86,027 patients who underwent carotid procedures between 2015 and 2019 using retrospective data from the VQI registry, a consortium of more than 400 centres in North America. In total, 7,664 patients (8.9%) underwent TCAR and 78,363 patients (91.1%) underwent CEA. The analysis cited increased use of TCAR, with 15 centres performing both TCAR and CEA at the beginning of the analysis period (2015), increasing to 247 centres at the end of the analysis period (2019), which represents a more than 16-fold increase in centres performing TCAR. The use of TCAR as a percentage of total carotid revascularisation procedures also increased, from 90 of 12,276 procedures (0.7%) in 2015 to 2,718 of 15,956 procedures (17.0%) in 2019, which represents a 24-fold increase over five years.

Importantly, the analysis also revealed centres that adopted TCAR had a 10% reduction in the likelihood of MACE at 12 months compared to those centres that continued to perform CEA alone (odds ratio, 0.90; 95% confidence interval [CI], 0.81–0.99; p=0.04).

“The publication of these findings in JAMA is another powerful reminder that TCAR gives the vascular specialist more options when treating carotid artery disease to the benefit of all carotid patients,” said Erica Rogers, Silk Road Medical CEO. “We are confident that as more and more practices adopt TCAR, providers will recognise the overall benefits of a less invasive approach and

will further drive TCAR toward standard of care.”

PatenSee initiates firstin-human trial with its contactless imaging surveillance system for haemodialysis patients

PatenSee has initiated a first-in-human clinical trial to assess its machine visionbased surveillance system, a press release from the company reveals. The trial, led by Benaya Rozen-zvi, director of the Institute for Nephrology and Hypertension at Rabin Medical Center (Petah Tikva, Israel), will evaluate the system’s ability to perform contactfree surveillance of fistula stenosis similar to a nurse’s physical exam of haemodialysis patients.

“The clinical data we collect will be the first of its kind and will provide a critical step towards a reliable contact-free early detection tool for fistula stenosis,” explained Rozen-zvi.

PatenSee imaging surveillance system

“Keeping the fistula open is a major clinical need, and early detection of stenosis allows for both simpler treatment and better prognosis for the patient. The non-invasive, contactless nature of PatenSee’s system adds another important benefit for both inpatient settings as well as in homecare in the future. The ability to assess patients effectively at a distance has become particularly important for both patients and clinicians during the worldwide COVID-19 pandemic.”

“The trial initiation is a significant milestone for PatenSee,” said Gal Goshen, CEO of PatenSee. “We are excited to complete all bench testing required to bring the system to the clinical stage and look forward to providing a reliable early detection system for fistula stenosis that can save lives, reduce suffering, and address a challenge currently costing for payers and providers millions of dollars every year.”

The press release states that collaboration with the medical doctors and nurses involved in the trial enabled easy integration of PatenSee’s system into the patient workflow of the dialysis centre. The system is used in the predialysis waiting room with minimal to no intervention of the medical staff and no interruption to the workflow.

Real-world data on SeQuent Please OTW DCB presented

One-year findings of the CONSEQUENT all-comers observational study of the paclitaxel drug-coated balloon (DCB) SeQuent Please OTW (B Braun) were reported at LINC 2021 (The Leipzig Interventional Course; 25–29 January, online). Principal investigator Ralf Langhoff (Sankt Gertrauden Krankenhaus, Berlin, Germany) relayed low target lesion revascularisation (TLR) and mortality rates.

The prospective, multicentre study evaluates the safety and efficacy of the SeQuent Please OTW in the treatment of de novo and restenotic lesions in peripheral arteries above and below the knee. It includes a total of 784 patients and 879 lesions (almost one third TASC II C/ D lesions, 78.8% calcified and 44.6% occluded).

“We have represented real-world data in this all-comers registry,” said Langhoff. “Many registries are including mostly claudicants. But here, we had a really large group of CTLI [chronic limb-threatening ischaemia] patients— almost 50% had CLTI. Lesion length is also more challenging—13.3±9.3cm in the CLTI group and 10.8±9.1cm in the claudicant group. That is fairly realistic in terms of what we treat every day.”

Twelve-month findings include a TLR rate of 8.1% (CLTI patients, 6.3%; nonCLTI, 9.6%), a patency rate of 88.3% (CLTI, 89.9%; non-CLTI, 87.1%), and an all-cause mortality rate of 4.3% (CLTI, 7%; non-CLTI, 2%). Predictors for TLR included in-stent restenosis at baseline, lesion length, and female gender.

TLR rates were similar above and below the knee, commented Langhoff: “Restenosis rates are generally much higher in BTK [below-the-knee] arteries, but this was just not the case in the CONSEQUENT registry. This is another hint that the SeQuent Please OTW DCB seems to work in BTK arteries”.

The group also carried out additional analysis with respect to mortality in response to the findings of the 2018 meta-analysis by Katsanos et al: “We did not see any difference—as predicted—in all-cause mortality in terms of paclitaxel dose. This is only one-year data, but we didn’t see any correlation so far. Three- and five-year data will be collected and presented later.”

First patient enrolled in SUCCESS PTA post-market study of Selution drug-eluting balloon

MedAlliance has announced enrolment of the first patient in SUCCESS PTA, its large post-market study with the drug-eluting balloon Selution SLR for the treatment of patients with peripheral arterial disease (PAD). Selution SLR is a novel sirolimus-eluting balloon that provides a controlled sustained release of drug, similar to that of a drug-eluting stent (DES).

The objective of the study is to collect real-world safety, efficacy, health economics and patient reported

quality-of-life data in over 700 patients with PAD treated with Selution SLR. It is a single arm all-comers study including all lower limb indications and will cover at least 50 sites in Europe, Asia and South America. Patients will be followed-up at 30 days; six months; then every year out to five years.

The primary endpoint of the study is clinically driven target lesion revascularisation (CD-TLR) at 12 months. Secondary endpoints include device success and procedure success; major adverse limb events (MALE); and target limb revascularisation (TLR).

“Given the impressive performance of this novel device in earlier studies, we are very excited to see how Selution SLR will perform in a larger group of patients in a real world setting”, commented the study’s principal investigator Michael Lichtenberg (Arnsberg, Germany).

“SUCCESS PTA is part of the SUCCESS post-market study family, designed to show patient benefits in real world use of our technology”, added chairman and CEO Jeffrey B Jump. “This is the largest study we have ever undertaken with Selution SLR, involving the most diverse group of patients. We are confident that the results will confirm the safety, efficacy and cost-effectiveness of our sirolimuseluting balloon.”

In February 2020 MedAlliance received CE mark approval for Selution SLR in the treatment of PAD. This award was supported by results from the first-in-human study.

Data from the SUCCESS PTA study will be part of the clinical evidence supporting CE mark renewal in 2023/2024 under the new European Medical Device Directive (MDR).

Selution SLR has also received US Food and Drug Administration (FDA) breakthrough device designation status

Selution SLR

for peripheral below-the-knee lesions as well as for the treatment of AV-Fistula.

SELUTION SLR’s technology involves unique MicroReservoirs made from biodegradable polymer intermixed with the anti-restenotic drug sirolimus. These MicroReservoirs provide controlled and sustained release of the drug. Extended release of sirolimus from stents has been proven highly efficacious in both coronary and peripheral vasculatures.

MedAlliance’s proprietary CAT (Cell Adherent Technology) enables the MicroReservoirs to be coated onto balloons and adhere to the vessel lumen when delivered via an angioplasty balloon.

April 2021 | Charing Cross Special Edition

Positive Luminor DCB data from EffPac and TINTIN trials presented at LINC 2021

New clinical evidence for the use of the Luminor drug-coated balloon (DCB; iVascular) in complex lesions with long-term follow-up has been presented on the main session of the Leipzig Interventional Course 2021 (LINC; 25–29 January, online). These outcomes show Luminor DCB has “outstanding performance” in the most common peripheral lesions.

Ulf Teichgräber (Jena University, Jena, Germany), principal investigator of the EffPac Trial, explained during his presentation at LINC that at threeand-a-half years, a significant clinical and haemodynamic improvement was achieved, with an “amazing” target lesion restenosis (TLR) rate (freedom from TLR: 90.1%). He also remarked that no increased risk of death was detected, and that all-cause mortality was similar to plain balloon angioplasty.

Luminor demonstrates “good” efficacy and safety outcomes, even at long-term follow-up, he said.

Investigating the performance of the Luminor DCB in complex and long femoropopliteal lesions, the newlyreleased two-year follow-up outcomes of the TINTIN trial corroborate the efficacy of the Luminor DCB. In lesions with a main length of 24.3cm, the combined therapy of Luminor and the iVolution self-expanding stent obtained a primary patency of 90.5% at one-year,

Market watch 41 and freedom from TLR of 89.4% at two years. Koen Deloose (AZ Sint Blasius, Dendermonde, Belgium), principal investigator of the trial, stated that: “The combination of vessel preparation, DCB, and self-expanding stent is the key to success in real life lesion treatment”.

CLEAN3 trial outlines potential new best practices for peripheral IV catheters

BD announced that new clinical data have found robust evidence that using a vascular care solution can help improve outcomes for patients requiring peripheral intravenous catheters (PIVCs).

Results of the CLEAN3 trial, published in The Lancet Infectious Diseases, showed that use of the BD vascular care solution resulted in fewer PIVC failures compared with the standard group (34.8% vs. 47.5%, respectively) and extended the median time between catheter insertion and failure (50.4 hours vs. 30 hours, respectively). PIVC failure was defined as any premature removal of PIVC before end of treatment—other than for routine replacement—and included phlebitis, infiltration, occlusion, dislodgment, local infection and catheter-related bloodstream infection (whichever occurred first).

The CLEAN3 trial also evaluated skin antiseptics with 2% chlorhexidinegluconate (CHG) 70% isopropyl alcohol (IPA) single use, sterile applicator versus 5% povidone iodine (PVI) 69% ethanol

applied with sterile gauze in preventing infectious complications related to the use of PIVCs (catheter colonisation: 0.9% vs. 16.9%, respectively; local infection: 0% vs. 1.2%, respectively).

The trial, which involved approximately 1,000 patients from nine different medical wards within a single university hospital (Poitiers University Hospital, France), evaluated PIVC failure rates by comparing the BD vascular care solution for PIVCs, which included an integrated PIVC (BD Nexiva), a positive displacement needle-free connector (BD MaxZero), a disinfecting cap (BD PureHub) and a sterile prefilled flush syringe (BD PosiFlush)—compared with a standard group, which included a straight

Luminor DCB

safety PIVC (BD Insyte Autoguard BC Winged), extension set three-way stopcock; the PIVCs were continuously infused with saline or polyionic solution, by gravity.

“The findings of the CLEAN3 trial support the use of an integrated solution as the best practice standard

when peripheral IV catheter dwell time is expected to exceed 24 hours,” said Olivier Mimoz (Poitiers University Hospital, Poitiers, France), principal investigator of the CLEAN3 trial.

“Furthermore, the study shows that the use of 2% CHG-70% IPA single use, sterile applicator should become the first-line antiseptic for skin disinfection prior to PIVC insertion. We believe that the results can be extrapolated to all adult patients admitted to a medical ward requiring a PIVC placement and, by extrapolation, to those admitted to a surgical ward.”

RelayPro US transection pivotal study completes enrolment

Terumo Aortic has announced completion of enrolment of the RelayPro traumatic injury (RelayPro-T) investigational device exemption (IDE) study in the USA. RelayPro is a low-profile thoracic stent graft device designed to expand the treatment of thoracic endovascular aortic repair (TEVAR) to patients with smaller access vessels. The RelayPro-T study has successfully enrolled a total of 50 patients with traumatic injury of the descending thoracic aorta at 16 sites across the USA. The purpose of this prospective, multicentre, non-blinded, non-randomised study is to analyse endovascular repair of traumatic aortic injury, or transection, usually caused by high speed impacts such as those in road traffic accidents or serious falls.

Charing Cross Special Edition | April 2021

42 Market watch

Industry News BGF announces multi-million investment in Vasorum

Ireland’s largest growth capital investor—BGF—has completed a €6 million equity investment in Vasorum Limited.

Vasorum is a Dublin based business specialising in devices used to close arterial punctures in vascular, cardiology, radiology and neuroradiology procedures. Based in Dublin, the company is led by founder and CEO, Jim Coleman, and former CR Bard senior executive, Chas Taylor.

BGF invests in minority positions in growing businesses and aims to support and facilitate the growth plans of founders and owners. BGF in Ireland is supported by the Ireland Strategic Investment Fund (ISIF) and the main Irish banks.

Vasorum developed and markets the Celt arterial closure device (ACD), which is used to close femoral artery punctures. The Celt ACD is a class III medical device based on a patented platform technology, which was approved by the US Food and Drug Administration (FDA) in 2017, and has been used in over 70,000 patients to date.

BGF’s investment will be used to accelerate the commercial roll-out of

Celt ACD in the USA and to invest in new product development.

Terumo reaches agreement to acquire predictive analytics specialist Health Outcomes Sciences Terumo Corporation has signed a definitive agreement to acquire all assets of Health Outcomes Sciences, a specialist in predictive analytics and clinical decision support for healthcare organisations.

“The acquisition of Health Outcomes Sciences and the ePRISM platform expands Terumo’s presence in the digital healthcare arena and represents a compelling growth opportunity for our company. It further allows Terumo to deliver innovative digital solutions, providing healthcare systems with critical data needed to lower the cost of healthcare delivery while substantially

Celt arterial closure device

improving patient outcomes,” said Toshi Osada, president of Terumo Corporation’s Cardiac and Vascular Company. ePRISM delivers a patient’s unique risks to physicians prior to treatment, based upon a calculation that includes their unique disease severity, comorbidities and demographics. The use of validated predictive models in routine care has the capacity to improve the consistency, outcomes and costeffectiveness of care across various cardiac procedures and care pathways, Terumo said in a press release.

“When combined with Terumo’s 100-year history and commitment to transforming global healthcare, our ePRISM technology will enable healthcare providers to deliver uniquely focused patient care; improving patient satisfaction, decreasing variability, optimising outcomes and minimising costs.

“This acquisition provides Terumo with a digital solutions platform that can be scaled globally across multiple healthcare segments,” said John Spertus, founder of Health Outcomes Sciences.

The acquisition is expected to close in February 2021. Following the close, the ePRISM platform will be integrated into Terumo Business Edge, a business unit of Terumo Medical Corporation.

Transit Scientific announces close of its Series A financing round Transit Scientific has announced

the close of its Series A financing round. The round was led by a large multinational investor and joined by previous seed investors.

Transit Scientific achieved US Food and Drug Administration (FDA) clearances and multicentre, multiuser, safe-patient-use of its XO Score angioplasty scoring-cutting platform and separate XO Cross 0.014” and 0.035” microcatheter platform in late 2020.

“XO Score successfully dilated multiple lesions that were resistant to standard or high-pressure balloon angioplasty during our first patient uses in haemodialysis fistulas,” said Jeffrey Hoggard (Raleigh Access Center, Raleigh, USA).

“It was particularly beneficial to be able to deploy the XO Score device with a standard percutaneous transluminal angioplasty (PTA) balloon in the juxtaanastomotic position and dilate the lesion at low and controlled inflation pressure.”

The XO Score is a novel sheath that converts regular angioplasty balloons into vessel prep scoring and cutting systems. The device is indicated for treatment of peripheral vascular stenosis including haemodialysis fistulas and grafts.

XO Score’s 22 individual scoring and cutting struts rotate 90 degrees to score and cut upon balloon inflation and then rotate 90 degrees back upon balloon deflation to facilitate balloon re-wrap.

The technology also allows for infusion at the site of treatment.

Calendar of events 19–22 April CX 2021 Vascular and Endovascular Controversies Digital Edition Online

Please be advised that the events listed opposite, because of COVID-19, are subject to change. Please check the relevant website for further details as the event may be cancelled, postponed, or become a virtual event.

www.cxsymposium.com

27–28 May Pacific Northwest Endovascular Conference (PNEC) Seattle, USA www.pnec-seattle.org

September

idelines scular gu g Global va limb-threatenin ic on chron Redefining a ia: ischaem ease dis critical

Limbof Chronic work Management es on the years of collaborative s and r Guidelin surgeon of four of having Global Vascula the product chronic limb- r The goal tion of the year sees the world. for patients with for Vascula The publica Ischaemia this ys s around the Society publication. The Threateningr experts and societie treatment pathwacement from r es’ of Vascula the guidelin by vasculato agree on the optimal ed in an announ fruition in European Journal describ come to the providers ischaemia was (JVS). journals: which has r Surgery societies’ threatening a “quixotic quest”, two of the the Journal of Vascula as Surgery was published in and (EJVES) document scular Surgery and Endova evaluation the definition, focuses on global patient he document ent of a large with mortality, and managem a disease associated particular and life. With population quality of practice, creating n, and impaired amputatio evidence-based as well as research, on guiding emphasis ks for treatment evidence or ed framewor standardis areas of low-levelperception of the insight into the overall providing stages of severity. and changing for spectrum and unmet needs, include a wider Conte from the Society disease to were Michael from the European from Co-editors Philippe Kohl Andrew Bradbury Surgery, and Vascular Nearly 60 Vascular Surgery Societies. ts Society for of Vascular Participan Federation that on the project. the World authors worked represented all specialties additional and . continents n of spanned six tening ischaemia limb-threa to the publicatio treat chronic Vascular News prior Vascular Guidelines to Speaking “the Global for Vascular , Conte said and the guidelines effort from the Society Vascular Surgery all are a combined Society for who have European Societies, Surgery, the of Vascular the past.” In the effort Federation in the World nt guidelines guidelines, Conte independe ive joint produced that we set of collaborat important project we are to create a and most —which first very limb ischaemia said, “the .” was advanced tening ischaemia undertook chronic limb-threa now calling is in a name? used definition to CLTI: What From CLIterminology from the widely limb(CLI) to chronic of a key shift The shift in limb ischaemia indication is of critical patient (CLTI) this g ischaemia g and treating threatenin around lising, identifyin the terminology in conceptua changed . “We have population

T

2019 | Issue

83

en: Alan Lumsd

Profile

Page 26

Page 29

nted” “Unprecede t developmen ic of NICE aort guideline aneurysm

Institute N of the National guideline VERSIO THE DRAFT Care Excellence (NICE) on in and for consultati for Health when released that patients with ndation created a furore, be offered its recomme should only 2018, with d aneurysm able to undergo an unrupture if they were fit and providers open surgery, . Many surgeons, service guideline draft the procedure ers have called the n has been and stakehold and its publicatio “unimplementable” since then.

Board,” deferred the NICE repeatedly of the now sits with UK), president “The guideline (London, and Ireland Loftus Ian Britain says for Great nted. “There Vascular Societycalls this step unprecede re-wording who sides and (VSGBI), ise on both ,” he tells Vascular the must be comprom workable guidance closely with to make this that NICE is working .

News, noting progress the guideline onal Interventi ers to Society of stakehold in discussion the British VSGBI and together been of (BSIR) have cated the concerns of Radiology and communi a letter to members with NICE g ty. In challengin communi has been set the vascular writes: “It is no date VSGBI, Loftus and at present there with NICE, for all concernedWe remain in touch help to find a n. to our for publicatio reiterated our desire Conte interests of Michael about the fact that [...] and have is in the best “to recognise solution that did raise our concerns and tening workable Conte said, limb-threa NICE The He adds: “We constitutes this problem,” s, with both scenarios. patients.” practice, what of the guideline in different it.” in current suggests that to change the wording may be different limb ischaemia were unable ischaemia below which of critical BSIR, but is okay. value of perfusion previous concept everyone threshold which there is some and above the expanding is critical, 4 diabetes and on page everyone is that with Continued What we realised

18–21 August SVS Vascular Annual Meeting San Diego, USA www.vascular.org

25–29 September Cardiovascular and Interventional Radiological Society of Europe (CIRSE) Annual Meeting 2021 Lisbon, Portugal

28–29 September European Society for Vascular Surgery (ESVS) 35th Hybrid Annual Meeting Rotterdam, The Netherlands and online www.esvs.org/events/35th-annualmeeting-2021

4–7 October CX Aortic Vienna Online www.cxaortic.com

4–7 October VIVA: Vascular InterVentional Advances Las Vegas, USA www.vivaphysicians.org/futuremeetings

www.cirse.org.events/cirse2021

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