Vascular News 101 – February 2024 European Edition

February 2024 / Issue 101

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EUROPEAN EDITION Featured in this issue:

2 Looking ahead

Welcome to our European edition

Europe

North America

6 CX 2024 preview

Aortic highlights

14 P rofile Daniel Clair

23 Trainee column

Introducing Sarah Sillito

Could metformin be first- ever medical treatment that is effective at managing aneurysm disease?

L-R: Ramon L Varcoe, Sahil A Parikh and Brian G DeRubertis

LIFE-BTK breathes life into drug-eluting resorbable scaffolds in breakthrough for below-the-knee arteries Results of the LIFE-BTK randomised controlled trial show that, in patients with chronic limbthreatening ischaemia (CLTI) due to infrapopliteal artery disease, an everolimus-eluting resorbable scaffold was superior to angioplasty at one year with respect to the primary efficacy endpoint.

R

amon L Varcoe (Prince of Wales Hospital and University of New South Wales, Randwick, Australia) shared this and other key findings at Transcatheter Cardiovascular Therapeutics (TCT) 2023 (23–26 October, San Francisco, USA) on behalf of co-principal investigators Brian G DeRubertis (New York Presbyterian–Weill Cornell Medical Center, New York, USA) and Sahil A Parikh (Columbia University Irving Medical Center, New York, USA). The trial results were simultaneously published in the New England Journal of Medicine (NEJM).

Parikh shared his thoughts on the significance of these results with Vascular News: “This trial is the first of its kind to demonstrate superiority of a technology for below-the-knee [BTK] intervention along a relatively long time point for this patient population.” He described the effects of the technology as durable and noted they are “continuing to diverge” at the 12-month time point. “It is a highly clinically significant result.”

Peter Schneider (University of California San Francisco, San Francisco, USA) provided some context on the results for this newspaper, noting that LIFE-BTK follows multiple

failed trials in the BTK segment. “The key thing I think is that we do not have the tools we need to treat BTK disease. Yes, catheter-based treatments for limb salvage are quite good, they performed well in both the BEST-CLI and BASIL-2 trials, but it is still somewhat limited in terms of the number of options we have,” he said. “We have had a number of failed trials below the knee—three failed [drug-coated balloon] trials and one failed drug-eluting stent trial—and the fact that we now have a successful trial is really [...] wind in the sails of this whole effort to try to improve the tools and the approaches that we have for BTK disease.”

This is a tool that all of us are going to want to have on our shelf.”

Peter Schneider

THERE IS A GLOBAL interest in assessing whether metformin, which has a long track record of safety and efficacy, is relatively inexpensive and is taken by millions of people every day for type 2 diabetes, has an effect on the progression of abdominal aortic aneurysms (AAA).

The LIMIT trial, a prospective randomised, level one, placebocontrolled, blinded trial, sponsored by the National Institutes of Health (NIH), is designed to investigate whether metformin significantly prevents the enlargement of existing AAAs in non-diabetic people.

“It is difficult to make an asymptomatic patient better. And so, you want a treatment that is not going to be very arduous, and not be very high risk. [It should be] relatively inexpensive, [and] easy to take, and metformin checks all those boxes,” explained Ronald L Dalman (Stanford, USA) at the 2023 VEITHsymposium (14–18 November, New York, USA), who invites the US vascular community to get involved in the trial.

“If metformin works in this application, it may also work in secondary treatment after [a] patient has had endografting to reduce the need for secondary procedures for endoleaks, for graft migration, or aneurysm enlargement. It could be [used] in a variety of applications both as a de novo treatment, as well as an adjunctive treatment following surgery. Here is something that could be a complement to surgical management, both before, during or after surgical intervention,” added Dalman, who is the Walter C and Elsa R Chidester professor and Continued on page 9

Continued on page 5

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February 2024 | Issue 101

In This Issue

INTRODUCTORY EDITORIAL

Looking back and looking forward Vascular News is delighted to welcome professor of interventional radiology Robert Morgan (St George’s Hospital NHS Foundation Trust, London, UK) as editor-in-chief of our European edition for 2024.

I

t is with pleasure, but also a degree of sadness, that I write this introductory editorial for the first Vascular News issue for 2024. Roger Greenhalgh pioneered the introduction of Vascular News over twenty years ago and led its development and evolution to the mature publication that you all enjoy today.

Professor Greenhalgh’s passing in late 2023 left a void in the editor-in-chief’s chair at Vascular News. As one of the co-editors of the partner publication Interventional News, I have agreed to oversee the editorial duties for the European edition of Vascular News for the next 12 months. Ross Milner, professor of surgery at the University of Chicago (Chicago, USA) will take the helm for the North American edition. I am looking forward to the not unwelcome challenge of bringing the news to you about current vascular hot topics and developments therein as they unfold over 2024.

Before I look forward, I must convey my personal congratulations to Frank Veith and to all co-organisers of the VEITHsymposium, including the organisational anchor, Jackie Simpson, for an excellent 50th VEITH meeting in New York in November. The symposium was very well attended and there were several events held throughout the week to mark the impressive 50th anniversary milestone.

The scientific content was excellent as usual.

In this first issue in 2024, I would like to highlight a lead article on the potential implications for vascular practice of the LIFE-BTK drugeluting bioresorbable stent trial, with comments from the three principal investigators and reports of discussions from the

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late 2023 meetings including Transcatheter Cardiovascular Therapeutics (TCT), Vascular Interventional Advances (VIVA) and VEITH. A second lead article focuses on developments on the use of medical therapy for the treatment of abdominal aortic aneurysms. This issue also profiles Daniel Clair, who co-leads the PROMISE LimFlow trials.

We highlight the first presentation of the complete patientlevel dataset on paclitaxel and death that was presented to the US Food and Drug Administration (FDA) and may have assisted in the FDA letter in 2023 that allayed the fears about paclitaxel use in peripheral arterial disease. There is a preview of the aortic programme in the upcoming 2024 Charing Cross Symposium. There are also articles that discuss new data on two new carotid stent systems (CGuard and NeuroGuard), the one-year CLOUT data using the ClotTriever (Inari Medical) in acute deep venous thrombosis, and the 12-month outcomes data of a new haemodialysis vascular conduit. Finally, Rachel Bell, past president of the Vascular Society of Great Britain and Ireland provides a commentary on the recent sexual misconduct in surgery report.

Looking ahead into 2024, I am looking forward to seeing further data on the efficacy of limus devices in the femoropopliteal and below-the-knee segments and more importantly on the gradual arrival of comparative data between paclitaxel and limus devices in the lower limb circulation. Vessel preparation is an ongoing fertile field for research and the relative places of technologies such as lithotripsy and atherectomy in the armamentarium of vascular specialists and how they are used in association with angioplasty and stents, whether drug-coated/eluting or not is an ongoing interesting story. Finally, I am old enough to remember when deep venous arterialisation was investigated as a treatment option for inoperable chronic limb-threatening ischaemia in the late 1980s/early 1990s, so I am interested to learn how it will fare in the 2020s, and if it will turn out to be a viable benefit for the many patients with this condition and with no other therapeutic possibility.

I am looking forward to being your interim editor-in-chief for the next 12 months and I hope that you will continue to enjoy this publication as you have to date.

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ROBERT MORGAN is professor of interventional radiology and clinical director at St George’s London and president of the British Society of Interventional Radiology.

Editors-in-chief: Robert Morgan (European Edition) and Ross Milner (North American Edition) | Publisher: Stephen Greenhalgh Content Director: Urmila Kerslake | Head of Global News: Sean Langer Editor: Jocelyn Hudson Jocelyn@bibamedical.com | Editorial contribution: Jamie Bell, Bryan Kay and Will Date Design: Terry Hawes, Wes Mitchell and David Reekie Advertising: Rav Pankhania Rav@bibamedical.com and Jamia Trigiani Jamia@bibamedical.com Subscriptions: subscriptions@bibamedical.com Published by: BIBA News, which is a subsidiary of BIBA Medical Ltd BIBA Medical, Europe, 526 Fulham Road, Fulham, London, SW6 5NR, United Kingdom Tel: +44 (0) 20 7736 8788 BIBA Medical, North America, 155 North Wacker Drive, Suite 4250, Chicago, IL 60606, United States Tel: +1 708-770-7323 Printed by: Buxton Press. Reprint requests and all correspondence regarding the newspaper should be addressed to the editor at the United Kingdom address. © BIBA Medical Ltd, 2024. All rights reserved.

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NEWS IN BRIEF

THE LATEST STORIES FROM THE VASCULAR WORLD

n SEXUAL MISCONDUCT IN SURGERY: A recent survey of more than 1,400 individuals in the UK reveals that, in the past five years, nearly a third of female surgeons reported having been sexually assaulted by a colleague and over two-thirds reported having been the target of sexual harassment. In this issue of Vascular News, Rachel Bell (Newcastle, UK) shares her thoughts on the findings and advises what should be done to address the widespread issue of sexual misconduct within surgery.

For more on this story go to page 9. n KEY CAROTID QUESTIONS: Extolling the benefits of evidence-based practice, timely surgical intervention and intensive medical therapy, Dominic PJ Howard (Oxford, UK) spoke at the recent Vascular Society of Great Britain and Ireland’s (VSGBI) annual scientific meeting (22–24 November, Dublin, Ireland) on what needs to be known regarding carotid disease management.

For more on this story go to page 11. n NEW VENOUS DATA: David Dexter (Norfolk, USA) shared one-year data from the CLOUT registry at The VEINS 2023 (28–30 November, Las Vegas, USA). He informed delegates that this is the largest mechanical thrombectomy study in the field of deep vein thrombosis to date.

For more on this story go to page 24.

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If you have comments on this issue or suggestions for upcoming editions write to jocelyn@bibamedical.com

CONTROVERSIES

CHALLENGES

CONSENSUS

Vascular & Endovascular

Controversies Update Aortic Controversies

Peripheral Arterial Controversies

Venous & Lymphatic Controversies

Carotid & Acute Stroke Controversies

Vascular Access Controversies

The Hurting Leg Controversies

Vascular Trauma Controversies

23–25 APRIL 2024 TUESDAY-THURSDAY NEW VENUE, ExCeL LONDON, UNITED KINGDOM

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Programme Highlights

Vascular and Endovascular CONTROVERSIES

• BASIL-3 Podium First Presentation: Putting BASIL-3 in context Tuesday, 23 April • Late Breaker: BEST-CLI vs BASIL 2 - outcomes when comparing apples with apples Thursday, 25 April • Inaugural Roger M Greenhalgh Late Breaking Trials Session Tuesday, 23 April • NEW! Hands-On Carotid Workshop Thursday, 25 April

CX CO-CHAIRS:

ANDREW HOLDEN

DITTMAR BÖCKLER

ERIN MURPHY

45 YEAR LEGACY OF VASCULAR EDUCATION CONTINUES EDUCATION

INNOVATION

EVIDENCE

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February 2024 | Issue 101

Feature

self to work” as a central component of this, which, to him, means “no one should be reserved in who they are when they’re part of a team or at work.

No one should be trying to fit into a mould.”

Bhasin then outlined why it is important to be compassionate.

“Because bad things are happening,” he said, including “some truly horrible and completely unacceptable things,” before sharing a series of slides showing headlines detailing bullying, undermining and harassment in vascular surgery and the surgical world more widely.

PRESIDENT’S SYMPOSIUM

VSASM audience encouraged to ‘step over the line’ and lead with compassion

Balancing act

“Everyone in this room, whether you believe it or not, is a leader and therefore a role model,” Neeraj Bhasin (Huddersfield, UK) told the Vascular Society of Great Britain and Ireland’s (VSGBI) 2023 annual scientific meeting (VSASM; 22–24 November, Dublin, Ireland).

B

hasin was speaking during the President’s Symposium—an annual, topical session curated by the VSGBI president at the time. In 2023, it was the turn of now immediate past president Rachel Bell, consultant vascular surgeon at the Freeman Hospital in Newcastle upon Tyne, UK, to set the agenda. Bell had selected the topic of leadership, with compassionate leadership emerging as a theme common to multiple talks.

One of these talks was Bhasin’s, the title of which was ‘Step over the line’.

“The easiest way to create change is by being involved,” the consultant vascular surgeon and deputy medical director at Calderdale and Huddersfield NHS Foundation Trust and chair of The Circulation Foundation began. He told the audience that, if they wanted to see change, they needed to “make it happen, take ownership”—an attitude he not only encourages others to adopt, but one he shared was key to his applying for an associate medical director job early on in his career and has been instrumental in his role as a leader to date.

Bhasin then involved the assembled delegates, asking “provocatively” via audience interaction software ‘Do you hold a leadership position?’.

While admitting that the question was “slightly vague,” the presenter went on to comment that the 34% of people who answered ‘No’ “are wrong”.

He explained: “Everyone holds a leadership role—whether you are leading a ward round, whether you are doing a theatre brief, whether you are

teaching—everyone in this room will be perceived as a leader and therefore, you’re a role model.”

Capturing the audience’s curiosity with this message, Bhasin opined that leaders have a responsibility to be compassionate, which he defined as “making sure people feel seen, included, valued, safe and feel belonging, they feel part of your team”.

Invisible line

This is where Bhasin brought in the meaning of his talk’s title: ‘Step over the line’. It’s all about an “invisible line” between individuals taking that responsibility to be involved in change or improvement activity, he explained, with many individuals using phrases such as ‘They need to’ when referring to an unspecified group of leaders or managers in the organisation, instead of ‘We need to’. “What’s stopping you, what’s stopping me?” he asked, from stepping over this line. “You’ve got to take on the responsibility for doing that,” he advised the audience.

“I’m challenging people that after this session you step over the line,” Bhasin posited at the Dublin meeting.

Before delving into the specifics of compassionate leadership, Bhasin explained why he thinks clinicians should be in formal leadership roles.

“Clearly, there are lots of benefits to [an] organisation, but most importantly to our patients,” he said.

Bhasin expressed an acceptance that, while a formal leadership role is “not for everyone,” a dedicated clinical leadership role brings various benefits

to the individual who takes it on. He listed a few such pros: “It allows you to set the agenda, take ownership and create the change that you want to see.”

Here Bhasin shared some anecdotal benefits from his own experience, noting that a formal leadership role brought him “great variety” in his working life. “It keeps everything really fresh,” he noted.

Taking on a formal leadership role, according to Bhasin, takes a clinician into their ‘stretch zone’. He elaborated: “You feel challenged, you build up a

You absolutely need to have the courage to move away from that traditional, hierarchical leadership approach towards a compassionate leadership approach.” huge network, real job satisfaction and achievement, and you build lots of new skills, knowledge and opportunities.”

The presenter noted that clinical leadership is a “really privileged position,” but wanted to bring the talk back to his main point, that clinical leadership and being a role model “is for everyone and comes at all levels”.

This led to Bhasin looking more closely at compassionate leadership and the importance of “bringing your whole

The presenter stressed the importance of balancing compassion with pragmatism and the demands of dayto-day life in the vascular unit when it comes to leadership.

“You’ve got to be conscious of others, you’ve got to genuinely listen and create personal connections, step into someone else’s shoes and be inquisitive,” he said, while also emphasising that “we have a service to deliver and we have patients to care for” at the same time.

Finally, Bhasin touched on the importance of acknowledging and managing the power dynamic between a leader and other members of the team. “There are a lot of us here who have positional power,” he said, adding that “some of us know that, some use that and some of us will have that positional power imposed on us by others.”

The presenter stressed that a fundamental change in mindset is necessary when it comes to addressing the power dynamic between leader and team. “You absolutely need to have the courage to move away from that traditional, hierarchical leadership approach towards a compassionate leadership approach,” the presenter urged. On this note, he underlined the importance of being “open and vulnerable” as a compassionate leader, referring here to an instance when he was both—to a recorded talk he has pinned to his X (formerly Twitter) profile (@8NBX) about growing up as a British Asian. “You’ve got to be open and vulnerable as a compassionate leader because if you are, people will appreciate that you’re being honest, people will see you as being approachable and relatable and they will open up to you.”

Concluding his talk, Bhasin reiterated his point that everyone is a leader and therefore a role model, encouraging audience members to embrace the challenge of stepping over the line and being a leader by being part of their team.

“Be thoughtful, be inquisitive, create belonging for your team and create safety for your team, and then you will be able to take pride and energy from caring for and inspiring others,” he said during his closing remarks.

Issue 101 | February 2024

Point of View

COVER STORY

LIFE-BTK breathes life into drug-eluting resorbable scaffolds in breakthrough for below-the-knee arteries Continued from page 1

In this multicentre, randomised controlled trial, 261 patients with CLTI and infrapopliteal artery disease were randomly assigned in a 2:1 ratio to receive an everolimus-eluting resorbable scaffold (Esprit BTK; Abbott Vascular) or angioplasty.

The primary efficacy endpoint was freedom from amputation above the ankle of the target limb, occlusion of the target vessel, clinically driven revascularisation of the target lesion, and binary restenosis of the target lesion at one year. The primary safety endpoint was freedom from major adverse limb events at six months and perioperative death.

The authors report in NEJM that the primary efficacy endpoint was observed—by which they mean no events occurred—in 135 of 173 patients in the scaffold group and 48 of 88 patients in the angioplasty group (Kaplan–Meier estimate, 74% vs. 44%; absolute difference, 30 percentage points; 95% confidence interval [CI], 15 to 46; p<0.001 for superiority).

Parikh added that the primary safety endpoint was “statistically indistinguishable between the two groups”. Writing in NEJM, the investigators elaborate that this endpoint was observed in 165 of 170 patients in the scaffold group and 90 of 90 patients in the angioplasty group (absolute difference, -3 percentage points; 95% CI, -6 to 0).

Finally, the investigators relay in their NEJM

report that serious adverse events related to the index procedure occurred in 2% of the patients in the scaffold group and 3% of those in the angioplasty group.

Lessons learned

Varcoe, who spoke with Vascular News at TCT following his first-time presentation of the new results, remarked that the chosen endpoints were crucial to the success of the trial. “A lot of clinical trial design is designing endpoints and timeframes that allow you to see a treatment effect from a new experimental device.

This has been particularly challenging in the CLTI space,” he said. “One of the reasons why [LIFE-BTK] was successful is the way we designed the trial, in terms of its endpoints, which allowed the treatment effect to be demonstrated. That was very important. I suspect that a lot of the past trials which have failed to show a beneficial effect of the new device have done so not necessarily because they don’t work, but because the endpoints were designed incorrectly.”

Parikh noted that resorbable scaffold technology has “significantly improved” since the early iterations used in the coronary arteries. He expressed his hope for use of this technology in the peripheral vessels: “I would like to make clear that this is a new iteration of this technology,” he said. “The scaffold thickness is substantially less, it is in fact comparable to the contemporary drug-eluting coronary stents that we now use, with a thickness of less than 100 microns.”

Parikh added that the lesion lengths that can be treated now are much longer. “In fact, in this trial, the lesions that were treated were up to 17cm, with overlapping scaffolds,” he shared.

According to Parikh, the success of current resorbable scaffold technology is a testament to lessons learned from past versions. “It is a similar technology to predecessors, but has benefitted from the experience that we have learned from other trials, and what we

Working together to reduce the carbon footprint of vascular surgery services

Nina Al-Saadi Point of View Nina Al-Saadi (Wolverhampton, UK) presented the results of a survey on behalf of the Vascular Endovascular Research Network (VERN), Becky Sandford (London, UK) and Andy Garnham (Wolverhampton, UK) at the 2023 Vascular Society of Great Britain and Ireland’s (VSGBI) annual scientific meeting (22–24 November, Dublin, Ireland). Here, the team writes about the research, which looks at how vascular surgery can be made greener.

SURGERY IS A RESOURCEintensive environment, and it has been estimated that the carbon emissions generated by a single case equate to driving approximately 480 miles in a petrol-fuelled car.1 With this in mind, the Vascular & Endovascular Research Network (VERN) in conjunction with the Vascular Society of Great Britain and Ireland (VSGBI) and the Royal College of Surgeons of Edinburgh (RCSEd)

sought to identify the ways in which we can work together to reduce the carbon footprint of vascular surgery services.

The first step in doing this was to establish a baseline of current environmentally sustainable practices across vascular surgery services in the UK. To capture this, we developed the ‘Greener Vascular Surgery’ survey.

This survey consisted of four main sections: rethink, reduce, reuse, and

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have learned is that fastidious implantation technique, adequate sizing, and appropriate pharmacotherapy are really the mainstays of treatment, and they are probably critically important to all vascular interventions, but specifically using a drug-eluting resorbable scaffold.”

He urged caution when comparing use of resorbable scaffolds in different vessels, although notes that “in this specific instance, the technology has proven itself to be superior in a randomised controlled clinical trial”.

Speaking with Vascular News at Vascular Interventional Advances (VIVA) 2023 (30 October–2 November, Las Vegas, USA), DeRubertis shared his opinion that the results of LIFE-BTK will change CLTI treatment “quite substantially”. He elaborated: “Up until now we’ve had a number of devices for the below-knee space—atherectomy, IVL [intravascular lithotripsy]—but none of them have shown a true patency advantage over angioplasty alone. This is a device that will affect the mechanical issues that we deal with, including recoil and residual plaque, but it also will provide an antirestenotic effect and hit that biologic restenosis, so that combination is really going to advance our treatment options and improve patency, which is ultimately what matters most for CLTI patients.”

Schneider opined that “this is a tool that all of us are going to want to have on our shelf”. However, he advised that interventionalists “keep in mind that a randomised controlled trial […] is not the same as an everyday algorithm of when to use and in which patients and in which situation”. The next step, according to Schneider, should be to develop that algorithm.

Questions remain, he said, including ‘is this something we are going to be using every day, or something we are going to be using once in a while in specific situations?’ and “that is the part that I think we need to go forward and figure out”.

recycle, with the aim of capturing current practices across all outpatient, inpatient and theatre areas, identifying environmentally friendly practices and uncovering any potential obstacles to change. The survey was open to all vascular healthcare professionals for a period of three and a half months and was disseminated via Vascular Society mailing lists, VERN newsletter, and social media platforms.

We received 90 responses from over half of the vascular units in the country, this gave us a good overview of current practices in the UK. Widely employed environmentally friendly practices included the use of virtual, telephone and one-stop clinics. By curbing the need for travel to and from hospitals these practices reduce carbon emissions. Recycling policies were also common across the units we received responses from, particularly recycling policies for paper, cardboard, and plastic. An opportunity for creating policies to recycle vascular devices used in endovascular and open surgery was noted. The survey also shed light on other areas where we can further develop our practice including the use of automatic or pedal operated taps in theatre, reducing our use of paper in clinical notes and minimising the use of disposable materials. We also found that there is room to increase our engagement in discussions surrounding environmental sustainability with the clinical and management teams.

Potential obstacles to change were

also identified, with survey respondents citing competing priorities, lack of engagement, and inertia as the primary barriers to implementing more environmentally friendly practices.

Despite these obstacles, the collective sentiment from the responses highlighted the willingness of vascular professionals to engage and make changes to reduce our carbon footprint. Notably, whilst the Green Theatre Checklist2 is currently used in only 6% of the respondents’ units, 88% of respondents who do not use it reported they would welcome its use in their departments.

Overall, the survey findings not only helped us understand current practices, but also identified the readiness for vascular healthcare professionals to work together to develop and adopt more environmentally friendly ones. This all points towards a positive trajectory in shaping a more sustainable future.

Full results will be disseminated soon.

References: 1. Rizan C, Steinbach I, Nicholson R, et al. The carbon footprint of surgical operations. Ann Surg.

2020;272(6):986–95. https://doi.org/10.1097/ sla.0000000000003951 2. https://www.rcsed.ac.uk/professional-supportdevelopment-resources/environmental-sustainabilityand-surgery/green-theatre-checklist

VERN is a UK-wide trainee-led research network, Becky Sandford is a consultant vascular surgeon at Guy’s and St Thomas’ Hospital (London, UK) and Andy Garnham is a consultant surgeon at the Royal Wolverhampton NHS Trust (Black Country Vascular Network, Wolverhampton, UK).

February 2024 | Issue 101

CX 2024

6

AORTIC

Data and debate to bring new light to aortic controversies at CX 2024 The aortic programme at the 2024 Charing Cross (CX) Symposium (23–25 April, London, UK) promises to be “packed with new data” to fuel the debate over controversies in the aortic space. This is according to CX Executive Board member Tilo Kölbel (University Heart Center Hamburg, Germany), who spoke alongside the recently appointed CX co-chairs Dittmar Böckler (University Hospital Heidelberg, Heidelberg, Germany) and Andrew Holden (Auckland City Hospital, Auckland, New Zealand) in a CX Vascular Live broadcast that previewed the upcoming edition of the event.

T

he trio spoke upon the release of the CX 2024 preliminary programme, which offers a glimpse of what to expect from the three days of education, evidence and innovation in the treatment of aortic disease. The aortic segment of the CX Symposium—which Kölbel describes as one of the strongest he has seen in the symposium’s history—begins on Tuesday 23 April with a deep dive into aortic techniques and technologies, followed by a full day of presentations, debate and discussion of controversies in juxtarenal and aortic pathologies on Wednesday 24 April, and then by aortic arch and dissection controversies on Thursday 25 April. Alongside these main sessions, Alexander Zimmermann (University Hospital Zürich, Zürich, Switzerland) will be reprising the hands-on aortic workshop that aims to promote learning in an interactive setting.

“On the one hand we are going to have a very similar setup of sessions divided into techniques and technologies on [the] Tuesday,” Kölbel said of the opening day highlights. The focus will be on new devices and techniques, he explains, with an emphasis on edited cases. The focus on Wednesday and Thursday will switch to more “evidence-based” discussion.

“The most important thing is that this is a controversies year, so the focus will be on the debates,” explains Kölbel. “We have picked a number of very important discussions at the moment and very good discussants to help us answer important questions like what to do with juxtarenal aneurysms and how to treat them, the right minimal volume for aortic practices, balloon-expandable versus selfexpanding stents, polymer-based filling technologies, and spinal cord drainage in thoracoabdominal repair.”

The abdominal aortic aneurysm (AAA) segment of the programme, which takes place on Wednesday

time. At Charing Cross, a symposium was run on small aneurysm treatment globally and this year we plan to carry on that with an updated result on technologies which have shown some great promise.”

Turning to the thoracoabdominal portion of the programme, Böckler highlights that the unanswered question of how to treat patients with uncomplicated type B dissections will be addressed. Furthermore, a great debate will seek to establish whether best medical treatment remains the standard for uncomplicated acute type B aortic dissection.

“It is still a burning question, [that is] not answered yet. We have had two randomised trials, and Charing Cross has always been the symposium to get the newest evidence and we are going to see and listen to new trials coming up,” says Böckler.

Crucially, explains Böckler, the programme features 90 presentations, eight great debates and 15 first-topodium presentations which continue the legacy of innovation, education and evidence that the Symposium has embodied throughout its 45-year history.

Outside of the aortic programme, a full schedule of sessions will dig into the current controversies in all vascular domains, spanning peripheral, venous, acute stroke and vascular access, punctuated by CX debates, live and edited cases and workshop demonstrations.

Also in 2024, CX Aortic Live will be hosted 7–8 October in person in Vienna, Austria and also virtually.

24 April, features two Great Debates, with speakers debating the best treatment for juxtarenal AAAs, including motions in favour of fenestrated endovascular aortic repair (FEVAR) or endovascular suture aneurysm repair (ESAR), as well as the volume-outcome relationship of AAA repair calls for a combined recommendation of endovascular aneurysm repair (EVAR) and open aneurysm repair (OAR) hospital volumes.

Alongside controversiess, innovation will be a key focus in 2024, Holden says. “To touch on a few things, we are getting some new data on the branched graft technologies that we are seeing. Not only in the arch, which we are seeing an explosion in technologies, including off-the-shelf options for treating complex arch disease, but also some alternative technologies to manage that juxtarenal segment as well,” he explains.

Imaging technologies, including 3D imaging software For the and intravascular ultrasound first time in (IVUS), are also likely to be an 2024, the CX important feature, Holden adds, Symposium will as well as technologies geared be housed at a towards the prevention of aortic new venue, the ExCeL London disease progression. exhibition and “We have been really interested conference centre in London's in some technologies that are Docklands. As well as offering treating aneurysms that are easy access to Central London sub-threshold, to prevent them and airports via the newly-opened ever getting to the threshold to Elizabeth Line, the venue also offers expanded exhibition and need treatment,” Holden details. conference space, allowing a “Multiple centres around the return to the open workshop world have been involved, experience and the introduction of and some very early data were an expanded workshop hub in the presented last year for the first centre of the exhibition hall.

CX 2024: A new home for a new era

To view the entire CX 2024 preview, scan this QR code or visit cxvascular.com/ cx-vascular-live/

Issue 101 | February 2024

News

Randomised trial set to elucidate value of image fusion technology for aortic repair AN ONGOING UK NATIONAL To remedy this, Clough detailed that Institute for Health and Care Research a new technology—Cydar Maps (Cydar (NIHR)-funded randomised controlled Medical) image fusion guidance—was trial seeks to illuminate the value of an designed in order to accurately and image fusion guidance technology for in real time automatically overlay endovascular aortic repair. preoperative CT, volume-rendered In a presentation on the trial at aortas onto intraoperative the 2023 VEITHsymposium (14–18 fluoroscopy data.

November, New York, USA), Rachel The presenter noted that Cydar Maps Clough (King’s College London, is now a cloud-based product that London, UK) first outlined the issue incorporates three phases—planning, at hand. While endovascular navigation, and review. The devices are available to treat benefits of a cloud-based complex aortic disease using system, Clough relayed, a combination of branches include the fact that it is and fenestrations, she said, always updated, enables challenges arise when remote planning and review positioning these devices in of cases, and provides a Rachel Clough three-dimensional spaces. platform for sharing data “We currently use highwith other organisations contrast and high-spatial resolution CT or device companies. [computed tomography] angiography Furthermore, Clough said, the to both plan these procedures and to technology has the benefit of being design these custom-made devices,” able to aggregate data in an effort to Clough said. Until recently, however, develop data-driven clinical decision she noted that there was “no direct link” support. “During the planning, between these preoperative image data navigation, and review phases, the data and intraoperative two-dimensional are pooled and then analytics can be fluoroscopy images. used to try to predict outcomes,” the THIS ADVERTORIAL IS SPONSORED BY GORE

Type 2 endoleaks in AAA: What is their clinical relevance?

Michel Reijnen (Arnhem, The Netherlands) discusses the clinical relevance of type 2 endoleaks in abdominal aortic aneurysms (AAAs).

TYPE II ENDOLEAKS (T2ELS) ARE THE most prevalent of all endoleaks, accounting for 50% of the total incidence of this complication. The data show that up to 90% resolve or are not associated with sac enlargement, and <1% have a risk of aneurysm rupture.1 The incidence of T2EL has been correlated, although not uniformly, with the number and size of patent branches before exclusion. Studies have shown possible endograft dependence. In a recent retrospective study by Kuijpers et al,2 the authors concluded that the prevalence of T2EL is significantly higher with the use of polytetrafluoroethylene (PTFE)-based endografts compared with polyester (PE)-based endografts. No difference in reinterventions on T2EL and sac remodelling between the two groups was observed. However, longer term data on both PE-3 and PTFE-based4 stent grafts show similar sac behaviour and shrinkage rates.

The relation between sac remodelling and longterm survival described by O’Donnell et al5 has been repeatedly reported, and was recently confirmed by van Rijswijk et al,6 who found no differences in sac shrinkage rates between graft material or used devices.

presenter explained. She continued that a particular patient could be matched to similar previous patients, and not just necessarily in one centre, but across multiple centres, after which predictions of outcomes based on different device type usage could be provided.

Data-wise, Clough shared that the technology has been demonstrated in independent case-control series in both the UK and the USA to result in reduced radiation and procedure times in both standard and complex endovascular repair. In fenestrated cases, she added, it has also been shown to reduce the amount of iodinated contrast agent used. The presenter further noted a sustained reduction in radiation exposure for the operator after just 10 cases.

Integration into healthcare systems, however, will require further data. “We need to demonstrate that [Cydar Maps] provides similar operator benefit and similar or lower overall costs compared

Health technology has the potential to drive efficiency and cost savings, but its value must be demonstrated.”

The clinical significance of T2ELs is still being debated; however, the consensus in publications is that most T2ELs occur in the early period after endovascular aneurysm repair (EVAR) and have a benign course. Many T2ELs spontaneously resolve, but they are related to unfavourable sac remodelling.7 There is no clear evidence that sac expansion is a surrogate for rupture risk, although aneurysm rupture does occur—albeit very rarely—in patients with T2EL. A meta-analysis by Sidloff et al8 (21,744 EVARs, 1,515 T2EL) showed the rupture rate of all T2EL reviewed was 0.9%, and 43% of these ruptures had no sac expansion.

Several options to reduce T2ELs, with the goal of inducing sac shrinkage, are available or under investigation. I recently presented the results of the AAA SHAPE early feasibility study at the 2023 VEITHsymposium9 and showed after one-year a sack regression rate in AAA diameter of 58% compared to 40% in the Vascular Quality Initiative (VQI) database that was used by O’Donnell et al5 and an 82% reduction looking at sac volume.

Another option is aneurysm sac coil embolisation (ASCE) published by Fabre et al.10 Randomising ASCE against standard EVAR in patients with a high risk for T2EL, ASCE seemed effective in preventing T2ELs. A significant reduction in aneurysm volume and a decreased rate of reinterventions was observed two years after EVAR. Miura et al11 studied the effect of two-day blood pressure management (BPM) after EVAR and concluded that postoperative initial two-day BPM had a preventive effect on AAA sac enlargement out to midterm (five-year) follow-up, by Michel reducing the incidence of T2EL. Reijnen

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to comparators, as the UK is a valuebased healthcare system,” Clough stated. She noted that the UK National Institute of Health and Care Excellence (NICE) has a digital evidence framework that requires a high-quality randomised trial for any technology designed to guide treatment.

Against this backdrop, Clough and Tom Carrell (co-creator of Cydar Maps) applied for funding to NIHR for a randomised controlled trial to investigate the technology’s value. The funding was granted, and the investigators subsequently set up a prospective, multicentre, two-arm randomised controlled trial recruiting patients with abdominal aortic aneurysm (AAA) and thoracoabdominal AAA trial in 10 sites across the UK. Clough detailed that patients will be randomised in a 1:1 fashion, with the aim being to recruit a total of 340 patients.

“Health technology has the potential to drive efficiency and cost savings, but its value must be demonstrated,” Clough stressed in her conclusion.

“Cydar Maps has been shown to provide benefit compared to standard treatment in smaller studies for both complex and simple endovascular aortic repair, and we hope this NIHRfunded trial will provide data of sufficient quality for submission to NICE for evaluation, to understand the true value of this technology.”

The increase in evidence that a shrinking aneurysm should be the goal of EVAR and the clear role of T2EL in aneurysm remodelling may change the tone of the discussion in favour of preventive measures. In my view, further investigation is needed to determine whether induced sac shrinkage—by eliminating T2EL—is related to an improvement in overall survival. What the best strategy is, which patients would benefit from this treatment, and what other linking factors exist between AAA sac behaviour a nd long-term survival all need to be assessed.

References 1. Cifuentes et al. Management of endoleaks after elective infrarenal aortic endovascular aneurysm repair. JAMA Surg. 2023;158(9):965973.

2. Kuijpers et al. Prevalence of type II endoleak after elective endovascular aneurysm repair with polytetrafluoroethylene- or polyester-based endografts. J Vasc Surg. 2023 Sep 19:S07415214(23)02044-X. 3. Teijink et al. Five year outcomes of the Endurant stent graft for endovascular abdominal aortic aneurysm repair in the ENGAGE registry. Eur J Vasc Endovasc Surg. 2019;58:175-181.

4. Heyligers et al. Long-term outcomes of the endoprosthesis with low permeability design for the treatment of infrarenal aortic aneurysms.

Presented at: Charing Cross Symposium 2023.

5. O’Donnell et al. Aneurysm sac failure to regress after endovascular aneurysm repair is associated with lower long term survival. J Vasc Surg. 2019 February:414-422.

6. V an Rijswijk et al. Predictors of abdominal aortic aneurysm shrinkage after endovascular repair. J of Clin Med. 2022;11: 1394.

7. Dijkstra et al. Incidence, natural course, and outcome of type II endoleaks in infrarenal endovascular repair based on the ENGAGE registry data. J Vasc Surg. 2020 Mar;71(3):780-789.

8. S idloff et al. Type II endoleak after endovascular repair. British Journal of Surgery. 2013;100:1262-1270.

9. Reijnen et al. Sac dynamics after EVAR influence long-term survival.

Presented at: Veith Congress 11/14 2023.

10. Fabre et al. Prospective, randomized two centre trial of endovascular repair of abdominal aortic aneurysm with or without sac embolization.

Eur J Vasc Endovasc Surg. 2021 Feb;61(2):201-209.

11. Miura et al. Initial two-day blood pressure management after endovascular aneurysm repair improves midterm outcomes by reducing the incidence of early type II endoleak. J Vasc Surg. 2023 Oct 10:S0741-5214(23)02081-5.

Michel Reijnen is a consultant vascular surgeon at Rijnstate Hospital in Arnhem, The Netherlands.

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February 2024 | Issue 101

Feature

does well with bypass first compared to an endovascular-first approach.

“These are the patients who not only have good vein, but that tend to be on the healthier spectrum of the patient population; these are the patients that I didn’t necessarily see in the first five years of my practice,” Genovese noted.

“But simultaneously, the patients in the open cohort had a fairly high anatomic complexity,” she added, referencing that over 60% of patients had infrapopliteal targets and 51% of the endovascular arm required tibial interventions. “[This study has] made us realise that in the right patient population, in more complex anatomic patients, bypass first remains still a really good and durable option,” Genovese summarised.

BEST-CLI: One year on A dedicated session at the 2023 VEITHsymposium (14–18 November, New York, USA) aimed to unpack the ways in which clinical practice and attitudes in the field of chronic limbthreatening ischaemia (CLTI) have changed since the BEST-CLI trial was published back in November 2022. The trial’s principal investigators (PIs)—vascular surgeons Alik Farber and Matthew Menard and interventional cardiologist Kenneth Rosenfield (all Boston, USA)—invited a multidisciplinary panel of opinion leaders from both the USA and Europe to share their thoughts and highlight some unanswered questions.

“We don’t cure these people”

First to comment was vascular surgeon Peter Schneider (University of California San Francisco, San Francisco, USA). “One thing I think is worth calling out is the change over one year,” he began. Schneider recalled that, during a 2022 VEITHsymposium session on BEST-CLI, “everybody was worried in some way” about what was going to happen next. A year later, “that’s melted away completely”. This change, in Schneider’s view, is testament to the leadership of the three PIs. Schneider’s main point was that BEST-CLI has contributed to a recognition that CLTI treatment is “much more complicated” than revascularisation alone, predicting that the field is “going to become more like cancer treatment”. He continued: “These people have cancer. It was clear to all of us how sick they are, but now it will be clear to a much broader audience.”

Vascular surgeon Joseph Mills (Baylor College of Medicine, Houston, USA), current president of the Society for Vascular Surgery (SVS), expanded on Schneider’s point. “This cancer analogy works really well,” he said. “We don’t cure these people, and what we want to do is try to put them in remission for as long as possible.” Mills advocated the use of endpoints that look at diseasefree survival and wound-free period, highlighting their utility in assessing long-term outcomes. “We should start looking at what’s better for [patients’] long-term care and not even one- or two-year results, but what happens over the lifespan of that patient,” he said.

Antiproliferative therapy is key

Interventional radiologist Robert

Lookstein (Icahn School of Medicine at Mount Sinai, New York, USA) also commented, first echoing Schneider’s sentiment that “the discourse [around BEST-CLI] has become more constructive than deconstructive” over the course of the past 12 months, in large part thanks to the PIs’ leadership.

He was keen to stress, however, that it is “obviously concerning” BESTCLI reached different outcomes to BASIL-2—presented in April 2023.

“It should be recognised that these trials were designed to study different populations,” he noted. Lookstein also highlighted the fact that there were very few women and underrepresented minorities enrolled in these two trials and cautioned extrapolating the trial results to these specific demographics.

Lookstein’s main point had to do with the importance of antiproliferative therapy. He referenced a retrospective analysis presented earlier in the session by vascular surgeon Michael Conte (University of California San Francisco, San Francisco, USA) that suggested the best results for freedom from reintervention in the endovascular arm of BEST-CLI were seen in those patients treated with drug-coated balloons and stents. Lookstein stated “the endovascular arm would probably have had better outcomes” had the endovascular protocol been standardised with the use of antiproliferative therapy in the infrainguinal circulation. “We have massive amounts of data [showing] that [antiproliferative therapy] is superior to non-antiproliferative therapy,” he stressed, asking why— against this backdrop of evidence—any vascular specialist would withhold this technology from their patients.

In response to this point, Rosenfield, of Massachusetts General Hospital,

No more silos

pointed out that if he were to place a bare metal stent in a coronary vessel, “that would almost be malpractice”.

Menard, of Brigham and Women’s Hospital, highlighted that one of the very important current challenges is that of “how to get the best endo[vascular] and the best surgery out there”.

Lookstein shared his opinion on this: “I think it behooves all of us to either lobby the guidelines or to speak out.”

He mentioned again the “profound” data presented by Conte and posited, “I firmly believe that drug-coated balloons and stents must be considered the standard of care at this point.”

The discourse [around BEST-CLI] has become more constructive than deconstructive.”— Robert Lookstein

Put the patient first

Vascular surgeon Elizabeth Genovese (Penn Medicine, Philadelphia, USA) noted the endovascular-first nature of her clinical expertise, which stemmed from the fact that she had worked for five years in the south east of the USA where her patients had been “very medically complex and often poor surgical candidates”.

Once BEST-CLI was published, Genovese stated that she moved to offering a more “patient-first” approach.

Now, she relayed, her practice is framed around the question of which patients fall into the BEST-CLI cohort that

Interventional cardiologist Carlos MenaHurtado (Yale School of Medicine, New Haven, USA) also shared his thoughts on BEST-CLI, remarking that—at least in his opinion and at his institution— the trial was “incredibly important”.

He elaborated: “It made us come out of silos and it made us understand that CLTI is more than simply just revascularisation.” Mena-Hurtado stressed that, while there is “a lot of work to do,” it is important not to put blame on each other. “I think we need to create the spaces where we can come together and discuss how best to [treat these patients],” he commented.

“The single most important thing that I learnt from the trial was the fact that when we had a patient with CLTI come into our facility, we would be forced to look at [the case] together,” MenaHurtado said in summary. “We continue that practice up until today and I think it has made not only our outcomes better but our patients better.”

More work to be done

Vascular surgeon Maarit Venermo (Helsinki University Hospital, Helsinki, Finland)—who noted that her centre was the first site outside the USA to join the BEST-CLI trial—made a point about what is next in terms of research in this space. She referenced the “huge number” of future studies that are in the works, which she believes will inform decisions around which treatment is best for which subgroups of CLTI patients.

“Also, there will be a population who don’t benefit from endo[vascular] or open surgery,” she added, stressing the importance of taking this into account when making clinical decisions.

Farber, of Boston Medical Center, also encouraged audience members to look ahead to what is next, stressing that BEST-CLI and BASIL-2 are just the start. “No matter what your views are on [BEST-CLI] or BASIL-2, the exciting thing is that we have data coming in this space, which did not have a lot of data [before],” he shared, emphasising, however, that “there’s more work that needs to be done”. To this end, Farber highlighted that the “top priority” now is to “harmonise” BEST-CLI and BASIL-2 using patient-level data. “It’s an exciting time,” he summarised.

Issue 101 | February 2024

Point of View

COVER STORY

Could metformin be firstever medical treatment that is effective at managing aneurysm disease?

Continued from page 1

vice chair of surgery for clinical affairs at Stanford Medicine. He is also the inaugural executive editor for the Journal of Vascular Surgery publications suite.

Meta-analysis hints at potential benefit but evidence ‘not definitive’

There is some evidence available, albeit not without its limitations, to support the use of metformin in AAA management. A systematic review and metaanalysis of drug repurposing for the treatment of AAA—published online ahead of print the week following VEITH 2023 in the European Journal of Vascular and Endovascular Surgery (EJVES)— indicates that metformin and statins “may provide some effect in slowing AAA progression”.

Authors Joachim Sejr Skovbo Kristensen (Odense University Hospital and the University of Southern Denmark, Odense, Denmark) do acknowledge, however, that “no definitive evidence was found for any of the [12] investigated drugs in this study”. They posit that publication bias “may have influenced the positive findings”, and go on to stress that “further research is needed to identify effective medical treatments for AAA progression with more robust methodology”.

The investigators write that, while numerous medical interventions have been proposed to address the “significant” mortality risk presented by large

AAA, “no drugs have convincingly reduced AAA diameter between users and non-users AAA progression, rupture rates or repair of -0.73mm/year,” while statins “had an risk” to date. overall estimated mean difference of Kristensen et al’s systematic review and -0.84mm/year”. meta-analysis therefore set out to assess In the discussion of their findings, the the impact of repurposed drugs or dietary authors claim that the present study is “the supplements on slowing expansion rates, most comprehensive” to date investigating reducing rupture risk, or the potential association minimising risk of repair for between drug repurposing AAA patients. and progression of AAA. The investigators conducted While Kristensen and a systematic search of both colleagues stress that no observational studies and single drug class included randomised controlled trials in the study fulfilled all (RCTs) in five databases. required conditions to be They note in their EJVES considered as a favourable report that unpublished data treatment in patients with from two screening trials AAA in terms of decreasing Ronald L Dalman were incorporated in their the growth rate of AAA, review. The research team they write that metformin then performed meta-analyses for each identified drug and statins “showed the most promise” for the subclass, stratifying them by overall risk of bias. treatment of AAA patients. They explain: “These Sharing the results of their analysis in EJVES, drugs demonstrated a clinically relevant reduction Kristensen and colleagues report that 39 out of a total in growth rate and achieved a certain degree of 7,484 screened studies met the inclusion criteria. statistical significance.” However, they note that both They note that no studies on dietary supplements did so with high levels of heterogeneity. were included.

The authors go on to say that metformin was the Kristensen et al continue that a total of 84 cohorts only drug in the study showing a significant reduction were derived from the included studies, and that 12 in expansion rate after excluding high-risk-of-bias distinct drug groups underwent meta-analyses. studies, however with “exceedingly high risk “Two drug groups, metformin and statins, were of heterogeneity”. statistically significant in slowing AAA growth,” Kristensen et al posit that, given there are currently the authors write. They add that no low-risk-of-bias four RCTs underway investigating the impact of studies were included for these two drug groups, and metformin on individuals with AAA, including the that the results had “very high” heterogeneity.

LIMIT trial, “it is reasonable to anticipate that a metaKristensen and colleagues go on to specify that analysis incorporating these studies would provide a metformin, excluding high-risk-of-bias studies, precise assessment of its effects on the progression of “presented an estimated mean growth difference of this condition”.

Here is something that could be a complement to surgical management, both before, during or after surgical intervention.”

“Time for action” to address sexual misconduct in surgery

Rachel Bell Point of View A recent survey of more than 1,400 individuals in the UK reveals that, in the past five years, nearly a third of female surgeons reported having been sexually assaulted by a colleague and over two-thirds reported having been the target of sexual harassment.

The analysis, published in September 2023 in the British Journal of Surgery, was conducted by the University of Exeter, the University of Surrey and the Working Party on Sexual Misconduct in Surgery (WPSMS). Here, Rachel Bell (Newcastle, UK) shares her thoughts on the findings.

SEXUAL HARASSMENT AND misconduct in medicine is sadly too common and has been tolerated, hidden and brushed under the proverbial carpet for too long. So I would like to say a big thank you to Professor Carrie Newlands

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and her team for publishing this important work that has empowered us to take back some control and endeavour to change our culture.

As a woman in medicine, I was completely unsurprised by the findings

of the report and that is simply because I know of no female colleague that does not have an ugly story about inappropriate behaviour, misogyny or gaslighting in their career. However, I must seriously scold myself for my response because it seems that over the last 30 years somehow, I have become so accustomed to bad behaviour that I no longer see it. Anyone who knows me would say that usually I have no problem sharing my opinions or figuratively putting my head above the parapet—so why have I not been shouting at the top of my lungs? Do not get me wrong, over the years I have called out bad behaviour, but, in my experience, when you do this no one in your organisation knows what to do, no one wants to hear what you have

We need to ensure our fantastic, talented workforce feel safe, supported, and protected at work.

The responsibility for that culture change lies with all of us.”

to say, very few people know how to support you, and 9.9 times out of 10 the behaviour goes unchallenged. In truth I feel ashamed that I have not used my voice to speak up. Thankfully, this report has made people sit up and listen and it is time for change. In my opinion there are two areas of change that would make a difference.

The first is we need to actively work to change surgical culture. Whilst I am obviously biased and believe that surgery is an incredible specialty, that has been enriched by our increasing diversity, there is no doubt in my mind that our culture needs to change. We need to ensure our fantastic, talented workforce feel safe, supported, and protected at work. The responsibility for that culture change lies with all of us.

The second is that we desperately need an independent national body for confidential reporting and investigation of sexual misconduct within our profession.

It should no longer fall under the purview of individual organisations as it is so difficult to manage well and is universally done poorly. Thanks again Carrie and team and the WPSMS for your excellent paper and report—now it is time for action.

Rachel Bell is a consultant vascular surgeon at the Freeman Hospital in Newcastle, UK, and immediate past president of the Vascular Society of Great Britain and Ireland (VSGBI).

February 2024 | Issue 101

10 News

CAROTID

Researchers report new outcome data for pair of investigational carotid stenting systems Results from two trials assessing the performance of investigational carotid artery stenting (CAS) systems—the Neuroguard (Contego Medical) and the CGuard (InspireMD)—were recently presented at VIVA 2023 (30 October–2 November, Las Vegas, USA).

C

hris Metzger (OhioHealth, Columbus, USA) shared late-breaking 30-day results from the C-GUARDIANS US investigational device exemption (IDE) clinical trial evaluating the CGuard embolic prevention stent (EPS) system for stroke prevention.

C-GUARDIANS is a pivotal trial designed to evaluate the safety and efficacy of the CGuard carotid stent system when used to treat symptomatic and asymptomatic carotid artery stenosis in patients undergoing CAS and at a high risk for carotid endarterectomy (CEA).

From July 2021 to June 2023, 316 patients were prospectively enrolled in this single-arm CAS study, performed at 24 sites in the USA and Europe. The primary endpoint was a composite of either: incidence of major adverse events including death (all-cause mortality), any stroke or myocardial infarction (DSMI) through 30 days post-index procedure; or ipsilateral stroke from day 31 to day 365 postprocedure.

Metzger, who is principal investigator of the C-GUARDIANS trial, shared that stenting with the CGuard carotid stent system in patients with carotid artery stenosis and at high risk for CEA had a death/ stroke/myocardial infarction (DSMI) rate of 0.95%, from procedure through 30 days of follow-up.

“The follow-up data from C-GUARDIANS once again support the safety of the CGuard EPS stent, with its novel MicroNet technology, as reflected in the low rate of major adverse events observed through 30 days,” said Marvin Slosman, chief

executive officer of InspireMD, in a press release.

“We believe the neuroprotective qualities of CGuard set it apart from competing stents on the market and should help accelerate the ongoing shift in carotid revascularisations from ‘surgery-first’ to an endovascular ‘stent-first’ approach. We look forward to reporting 12-month results as we continue to advance CGuard EPS toward potential FDA [Food and Drug Administration] approval in the first half of 2025.”

InspireMD anticipates reporting primary endpoint results from C-GUARDIANS—which may support a premarket approval (PMA) application—in the second half of 2024.

Late-breaking clinical results from the PERFORMANCE II carotid stent Chris trial were also presented at VIVA 2023.

Metzger PERFORMANCE II is a prospective, multicentre study evaluating the safety and effectiveness of the Neuroguard integrated embolic protection (IEP) system in 305 patients at 40 clinical sites.

“The one-year event rates in the PERFORMANCE II study are the lowest ever reported in any adequately powered, William prospective, multicentre study of any Gray type of carotid artery revascularisation, regardless of patient risk,” said William Gray (Main Line Health, Philadelphia, USA), co-national principal investigator of the trial. “These results can elevate the standard of care for patients with severe carotid artery disease who

No relationship found between DW-MRI lesions and long-term stroke risk following carotid revascularisation A secondary analysis of existing clinical trial data has indicated that new ischaemic brain lesions detected via diffusion-weighted magnetic resonance imaging (DW-MRI) following carotid artery revascularisation—either with carotid artery stenting (CAS) or carotid endarterectomy (CEA)—do not appear to have a relationship with long-term stroke risks.

“THE RESULTS FROM OUR analysis do not support the role of ischaemic brain lesions discovered on [DW-MRI] after carotid revascularisation procedures as risk markers for long-term recurrent stroke or TIA [transient ischaemic attack],” Gert J de Borst (University Medical Center Utrecht, The Netherlands) et al write in the journal Stroke. “However, as new periprocedural [DW-MRI] lesions seem to be a marker for early recurrent cerebrovascular events, future randomised studies are needed to

evaluate whether the effect of treatment on these lesions corresponds to the effect of treatment on procedural stroke before surrogacy can be validated.”

The researchers initially posit that five-year follow-up findings from the randomised International Carotid Stenting Study (ICSS) indicate an increased risk of recurrent stroke or TIA following a CAS procedure, but that the trial failed to demonstrate any association between DW-MRI lesions and recurrent stroke/TIA risks following CEA.“The establishment

are deemed appropriate for intervention by delivering demonstrated best-in-class stroke protection.”

In the PERFORMANCE II study, the reported 30-day stroke rate was 1.31% in the intention-to-treat analysis and 0.98% in a per-protocol analysis, with no major strokes or contralateral strokes, and all patients returning to baseline neurologically within 30 days, according to a Contego press release. At one-year follow-up (all stroke within 30 days, and ipsilateral stroke between day 31 and 12 months), the reported stroke rate was 1.68% in the intention-to-treat analysis and 1.35% in a per-protocol analysis. No major strokes or neurological deaths occurred in the study.

The press release details that the Neuroguard IEP system leverages Contego’s clinically proven IEP technology—a unique platform with a micro-filter integrated on the delivery catheter, which is designed to deliver added safety during stent placement and balloon dilation. The micro-filter with 40µm pores captures the micro-emboli that other protection mechanisms do not, the release adds, giving physicians the procedural confidence that comes with advanced stroke protection in the treatment of their patients. The Neuroguard closed-cell stent also utilises FlexRing technology, providing optimised radial strength and flexibility while leveraging nitinol’s proven long-term material performance, Contego further claims.

“The recent change in coverage by the Centers for Medicare & Medicaid Services (CMS) increases patient access to carotid artery treatment,” said Contego chief executive officer Ravish Sachar.

In addition to the PERFORMANCE II study—in which Neuroguard was placed via transfemoral or transradial access—the PERFORMANCE III study is currently enrolling patients to evaluate the same stent placed via direct transcarotid access.

“Our mission is to provide a new class of products which improve patient outcomes and procedural efficiency,” said Stacy Enxing Seng, operating partner at Lightstone Ventures and chairman of the board at Contego.

of the longer-term clinical relevance of the [DW-MRI] lesions after carotid revascularisation procedures is essential in the process of implementing a universally accepted surrogate outcome,” De Borst and colleagues note. “Today, thus far, there are no data describing adverse events in [DWMRI]-positive patients beyond five-year follow-up. Therefore, in this study, we intended to determine the long-term cerebrovascular outcome in [DWMRI]-positive compared with [DWMRI]-negative patients after carotid revascularisation procedures.”

The authors report that their secondary, observational, prospective cohort analysis included 162 patients with symptomatic carotid stenosis who were previously randomised to CAS or CEA in ICSS, and were subsequently included in the ICSS MRI substudy.

They further relay that the primary composite clinical outcome of their analysis was the time to any stroke or TIA during follow-up. Patients with new DW-MRI lesions on post-treatment MRI scans (DWI+) were compared with patients without new lesions

(DWI–), De Borst et al add.

For the 162 patients included in the ICSS-MRI substudy between January 2004 and October 2008, 110 general practitioners (GPs) ultimately provided long-term follow-up data for the present study. Discussing the baseline characteristics of this patient population, De Borst et al note that those in the DWI+ group were more often treated with CAS, while total cholesterol at randomisation was higher in the DWI− group.

The authors state that the median follow-up time was 8.6 years, and that Kaplan-Meier cumulative incidence for the primary outcome after 12.5 years of follow-up was 35.3% in DWI+ patients and 31.1% in DWI− patients.

With respective hazard ratios of 1.5 and 1.3, univariable and multivariable regression analyses did not show significant differences between these two patient cohorts, they add. Separate analyses relating to CAS and CEA, showed that the higher primary outcome rate in DWI+ patients across the entire cohort was mainly caused by events in the CAS group.

Issue 101 | February 2024

Feature 11

Evidence, timing and medical therapy: Key carotid questions addressed at VSASM 2023 Extolling the benefits of evidence-based practice, timely surgical intervention and intensive medical therapy, Dominic PJ Howard (Oxford, UK) spoke at the recent Vascular Society of Great Britain and Ireland’s (VSGBI) annual scientific meeting (VSASM 2023; 22–24 November, Dublin, Ireland) on what needs to be known regarding carotid disease management.

THE CONSULTANT VASCULAR surgeon at Oxford University Hospitals NHS Foundation Trust first addressed whether clinicians should be operating on any patients with carotid disease.

“We know from the NASCET, ECST and Veterans Affairs trials that early intervention for patients with highgrade symptomatic stenosis is very effective at preventing strokes,” Howard said. The presenter did point out, however, that these trials are over 30 years old.

Howard stressed that advances in medical therapy over the last two decades have been “significant,” highlighting that some studies have suggested intensive medical therapy can reduce stroke risk by up to 80% in patients presenting with minor events.

The presenter also highlighted interim results from ECST-2, presented earlier last year, which found that at two years there was no obvious benefit of revascularisation on top of medical therapy for carotid patients. However, he urged audience members to be aware that ECST-2 did struggle with funding, recruiting only 400 out of a planned 2,000 patients, and only randomised low-risk patients—both symptomatic and asymptomatic—with moderate stenosis.

Sharing some data supporting the notion that medical therapy alone may be adequate to treat symptomatic carotid patients, Howard pointed to a pooled analysis of older versus newer randomised trials looking at intervention. The data showed that, for patients on medical therapy whilst awaiting intervention, there is a “reasonably high” stroke risk over 120 days; in the newer trials, on the other hand, the stroke risk on medical therapy whilst awaiting intervention “appears to be very low, at around 2%”. Howard did urge caution with interpreting these data, however. “These events were only those that were collected after randomisation, and the majority of patients in these trials were randomised beyond two weeks of index event,” he shared with VSASM 2023.

Howard then referenced an ad hoc analysis of the POINT trial, which looked at dual antiplatelets versus aspirin for prevention of recurrent stroke. “We can see that dual antiplatelet therapy does reduce the risk of recurrent events in patients without carotid disease, and also in patients with symptomatic disease,” he

informed the audience. The presenter did identify an “elephant in the room” in this analysis, however, which is the fact that patients with symptomatic carotid disease, despite dual antiplatelet therapy, have a much higher recurrent stroke risk than those without carotid disease.

“We also have to be aware that our surgical risks have come down,” Howard stressed. Over the last two decades, he specified that procedural risks have more than halved with regard to stroke or death in the perioperative period. “We might say it’s simply because we got better at operating; I think it’s probably because of better medical therapy before and after operating, and also possibly due to higher volume centres performing more operations,” the presenter opined.

Patient compliance

The lack of patient compliance with various therapies was also addressed.

Howard detailed: “Intensive medical therapy, intensive exercise and a Mediterranean diet are fantastic for our patients, but patient compliance with intensive medical therapy is less than 50%, one-third of our patients are found to have antiplatelet resistance in studies—and yet we don’t test for this so we don’t know whether we’re giving them optimal medical therapy or not—and compliance with lifestyle and exercise, which are arguably the most important interventions, is less than 10%.”

At this point, Howard acknowledged that trial participants may not necessarily represent the typical patient seen in the clinic. Here, the presenter

If we’re going to treat people and give them maximum benefit from urgent intervention, we have to prioritise carotid surgery for symptomatic patients as an emergency procedure.”

referenced the 20-year OxVasc study.

In 100,000 patients, Howard relayed that he and colleagues identified a “dramatic” fall in the rate of recurrent events. The presenter suggested that while this will be due partly to improvements in medical therapy, the results will also stem from the fact that patients are receiving treatment sooner.

“This brings us on to the fact that we are too slow,” Howard stated. “In fact, we’re getting slower.” In light of this, Howard urged: “If we’re going to treat people and give them maximum benefit from urgent intervention, we have to prioritise carotid surgery for symptomatic patients as an emergency procedure and put them on the next operating list.”

Here, Howard called attention to a “very exciting” trial in the pipeline— COMET—which will be running from Leicester, UK, and will look at randomising patients with symptomatic stenosis to endarterectomy versus best medical therapy.

Timing of intervention

Howard then turned his focus to timing of intervention after symptom onset. He reported that, when this topic was first looked at, it was Swedish registry data that suggested operating within the first few days of an event was “very risky”.

In the data, he specified, stroke or death was over 10% for those operated on within 48 hours. Despite this, the presenter relayed that larger datasets from the UK and Germany have now quelled concerns. “Actually, the event rates appear to be pretty similar to those patients operated on beyond 48 hours,” he communicated.

Conversely, Howard stated that early stenting, i.e. stenting within seven days of an event, “appears to be quite dangerous”. Referencing a pooled analysis of interventional trials, the presenter shared that patients receiving a stent within seven days have an 8.4% risk of stroke or death compared to 1.3% for those undergoing urgent endarterectomy.

The presenter then moved on to a “more common problem” faced by clinicians in day-to-day practice: the question of whether to operate following thrombolysis or mechanical thrombectomy. He mentioned that Ross

Dominic PJ Howard

Naylor (Leicester, UK) and colleagues conducted a meta-regression analysis on the topic, concluding that the safest time to operate on these patients appears to be at around six days post thrombolysis.

Looking at what the guidelines say, Howard shared that the new European recommendations continue with their advice that symptomatic patients who have greater than 50% stenosis should be considered for intervention (endarterectomy, not stenting) as soon as possible. There is a new recommendation in these guidelines, however, which says that a clinician should consider operating on patients receiving thrombolysis, but should wait six days before initiating surgery.

Finally, Howard looked at whether there is any way of selecting asymptomatic patients for intervention.

He mentioned the ACST trial, which did show that patients on triple therapy—antithrombotics, blood pressure control and statins—benefitted from intervention over a five- and 10year period.

The European guidelines, the presenter noted, suggest using a variety of criteria to try and help select patients who may benefit from intervention.

“The problem is that most of us don’t have these investigations available to us in our normal practice,” he remarked.

In order to try and get a definitive answer to this question, Howard pointed to a study he and colleagues recently had published in The Lancet, which looked at whether degree of stenosis may be predictive and help with decision making. “We found that, over the last 20 years, patients with high-grade asymptomatic stenosis have always had a two-to-three-fold increased risk of stroke compared to those with moderate stenosis,” he reported. “And this would appear to be a linear increase—as the degree of stenosis increases, so does the ipsilateral stroke risk.”

In view of this study, the presenter noted that the American guidelines have changed their recommendation to now suggest that asymptomatic patients with greater than 70% stenosis should be considered for intervention if they have a low surgical risk and a good life expectancy.

Summarising, Howard put forward that intervention for symptomatic carotid disease is “under scrutiny” in view of improvements in medical therapy. However, one of his key messages was thus: “If we’re going to operate on these patients, we should still be evidence based.”

The presenter continued that, at the moment, operating as soon as possible is important, yet time from event to intervention is currently too slow.

“Urgent endarterectomy is safe but urgent stenting is not,” was another key message, and Howard closed with the statement that “all patients require intensive medical therapy and lifestyle changes”.

February 2024 | Issue 101

12 News

PERIPHERAL

Changing course: The natural history of tibial claudication comes under scrutiny as interventions for “relatively benign” disease trend upward

looked at 11 studies covering current conservative management and intervention, and 16 studies probing peripheral vascular interventions or open surgery for claudication “found that there were consistently higher rates of major amputation or repeat intervention associated with revascularisation, and particularly with tibial interventions,” he said.

What of the guidelines and appropriate use criteria In the end, reflected Michael S Conte (San Francisco, USA), “it’s not the evidence”. The (AUC) in the arena of treatment for intermittent leading vascular surgeon and peripheral arterial disease (PAD) expert made the bold claudication? It’s a mixed bag, said Conte. While the statement during the recent 2023 VEITHsymposium (14–18 November, New York, USA) Society for Vascular Surgery (SVS) guidelines from as he pointedly asked a room full of colleagues: what is behind the trend that appears 2015 recommend against endovascular therapies to show tibial interventions for intermittent claudication are growing? for isolated infrapopliteal disease for claudication “because it is of unproven benefit and possibly THE QUESTION OF WHETHER OR NOT THE Hispanic and who had kidney disease.” harmful,” other bodies, such as the Society practice carries a reasonable risk or, rather, if the risks He delved deeper, pointing to evidence for Cardiovascular Angiography & “exceed the benefits” has long lingered, the chief of showing that the providers who were Interventions (SCAI), suggest that “this vascular and endovascular surgery at the University associated with higher use were more practice may be occasionally or rarely of California San Francisco (UCSF) told the audience. likely to be early-career interventionalists appropriate,” Conte said.

Ultimately, the preponderance of the data, Conte or surgeons, in the western half of the The SVS AUC for intermittent said, suggests the latter. So what of those reasons USA, in higher volume practices, more claudication saw unanimous agreement behind the recent trend? Conte, finding his rhythm, often based at ambulatory surgery centres that the risks outweighed the benefits regarding first turned to datasets outlining pattern of use.

(ASCs) or office-based labs (OBLs), and revascularisation for infrapopliteal disease, Michael S Vascular Quality Initiative (VQI) data from 2003– more commonly interventionalists versus he added.

Conte 2018 demonstrated that about 11% of claudication vascular surgeons.

So, to Conte’s original question: what interventions involved infrapopliteal arteries, with Conte then turned to recent VQI-VISION (Vascular explains the increasing use of tibial interventions for isolated infrapopliteal interventions or combined Implant Surveillance and Interventional Outcomes claudication? “It certainly is not the evidence that it interventions associated with a higher risk for major Network) data on patients who received infrapopliteal is helping people, because the evidence is simply not amputation compared to femoropopliteal interventions interventions, presented at last year’s VAM. there to support this concept of full revascularisation alone, he said. “This finding was particularly true in “You can see looking downstream that the risk of for claudication, with treatment of every lesion in sight patients with diabetes,” Conte added. conversion to chronic limb-threatening ischaemia on the angiogram,” Conte elaborated.

One research group looked at the influence of a [CLTI] was significantly higher among patients The data suggest other practice-level factors may competitive marketplace and found that working who underwent tibial interventions versus patients be at play, he reflected: economic incentives and in an area with high market competition seemed who had isolated femoropopliteal interventions the current reimbursement framework; elevated to be associated with a higher rate of using tibial for claudication—and the risk of needing repeat use in ASCs and OBLs; strong associations with interventions for claudication patients. “I guess, if interventions was significantly higher, suggesting that atherectomy; higher use among certain types of you have a lot of competition around you, you may be patients getting these procedures are being placed providers; meetings where live case demonstrations prone to be more aggressive in the patients that you at greater risk for deterioration of their disease and focus on technical elements of the interventions rather treat; these data seem to imply that competition in the multiple additional procedures,” he explained. than their appropriateness. area affects the utilisation of tibial interventions in As the data pile up, and many have questioned the “I guess that some providers believe that the claudicants,” Conte said. wisdom of such interventions, Conte asked: “Are we short-term risk of these interventions is low, and the He moved onto Medicare data from 2017–2019. really doing the right thing?” downstream harms are not tangible at the time, so they “Now you can see the numbers are a little bit different: “This alarming trend, from 11% to more recently have convinced themselves they may be providing a 28% of all claudication interventions involved around 30% of peripheral vascular interventions in the benefit,” Conte concluded. “That’s certainly not a basis infrapopliteal arteries, and of these more than a third USA involving a tibial artery for claudication, suggests for evidence-based practice, and with growing signals were isolated infrapopliteal and about a third were we may be at risk of changing the natural history of a of harm, the vascular community needs to address the multiple tibial arteries,” Conte continued. “This relatively benign disease,” he summarised. overuse and misuse of interventions that will erode the pattern was more prevalent in patients who are Black, Conte went further. A systematic review that public trust.”

Personalised postoperative anticoagulation needed to curb lower limb amputations “We’re going to see more and more amputations if we don’t figure out the right post procedure thromboprophylaxis regime as soon as possible,” Anahita Dua (Boston, USA) warned during the Kinmonth Lecture at the Vascular Society of Great Britain and Ireland’s (VSGBI) annual scientific meeting 2023 (22–24 November, Dublin, Ireland).

D

iabetes is a significant and growing problem for the vascular community, the associate professor of surgery at Harvard Medical School and vascular surgeon at Massachusetts General Hospital in Boston began. She explained to the audience: “Because our diabetic drugs are doing their job and the way we take care of these patients is getting better, they are living longer so we are seeing more of these patients.”

At the meeting, Dua noted that this rise in prevalence will be accompanied by a parallel increase in the number of associated complications, specifically “complications we, as a society, may not have dealt with before”. She highlighted one that is a particular cause for concern: the microvascular dissemination of the foot. And, to make matters worse, “we have nothing Continued on page 13

Issue 101 | February 2024

to help these ‘no-option’ patients,” she said.

Dua’s talk—titled ‘Going out on a limb to save a life and a limb’—first focused on deep venous arterialisation (DVA)—a new technique that, according to the presenter, “is kind of taking the world by storm”.

She first addressed some misconceptions. “There are going to be a couple of guys in the audience who are going to turn to their friend and say ‘we did this in the 80s’. No, you didn’t—I promise. You did some version of something that was called this in the 80s, but things have changed because technology and medicine have changed,” she said.

So, this is not a new concept, the presenter stressed, noting in fact that there are reports of attempts from 1881. Following a “big breakthrough” in the 1970s, however, she remarked that the technique fell out of favour “because it didn’t really work in the way it was meant to.” There were various reasons for this, according to Dua. “We were plagued by a lack of technology, lack of buy-in and lack of patients.”

The presenter highlighted some data on the new and improved iteration of this technique, first mentioning the PROMISE II trial, for which she was an investigator. While amputation-free survival was the primary endpoint, Dua focused on the limb salvage rate,

News 13

which was 76% in these patients who otherwise may have had no other option but an amputation.

This is where the presenter turned the audience’s attention to another study—CLariTI—designed to illuminate the ‘real-world’ amputation rate in the USA. The presenter reported that, in this study of 180 patients at 22 sites across the USA, up to 73% who underwent an amputation did not have a diagnostic angiogram, while 54% had no revascularisation attempts.

“We need to make sure that across the country all of these patients are getting

The future for these patients is very bright.” the same level of care,” Dua stressed.

The presenter continued that in patients who were told they had no conventional options for salvage and/ or had undergone two failed attempts at revascularisation, the limb salvage rate was 48% at one year—so, “about a coin toss,” as Dua put it. The pooled results from PROMISE I and PROMISE II, however, which the presenter reiterated focused on DVA, revealed a higher limb salvage rate of 73%.

“I really think that that is the future,

Mainstream media dig deeper into atherectomy use in the USA, SVS responds Further reports on the use of atherectomy in the USA have appeared in ProPublica.

The nonprofit investigative news outlet shared three articles in its latest round of investigations looking into Medicare claims data.

THE ARTICLES, LED BY A STORY entitled, ‘Thousands of patients may be undergoing vascular procedures too soon or unnecessarily’, were published in December 2023. The main article was accompanied by a profile of Caitlin Hicks, an associate professor of surgery at Johns Hopkins University School of Medicine (Baltimore, USA), who has been a prolific researcher in the area of overutilisation of certain vascular procedures.

The main article reports on a new analysis of Medicare claims by ProPublica and CareSet, a health analytics group. The investigation found that atherectomies “were performed on about 30,000 patients who had questionable need for them”.

The article proceeds to share a list of physicians who, for various reasons, stood out during the research. Some attracted attention “because of the

or the only thing we have, frankly, right now, for patients that are coming in with microvascular dissemination of the foot and no other options,” Dua opined, based on these data.

Anticoagulation: “One size fits all doesn’t work”

Despite the progress made for these patients technique-wise, Dua told the audience that the issue of postoperative anticoagulation is hindering outcomes.

“What do we do immediately after we’ve done this amazing, futuristic surgery?” she asked. “We put them on ‘one-size-fits-all’ thromboprophylaxis because we have little idea of what we’re doing.” The result is suboptimal outcomes with up to 20% of patients needing reintervention from stenosis or thrombosis in the first six months post procedure.

Dua advocated moving away from a “one-size-fits-all” approach, talking through some of the work she is currently conducting on this in her lab at the Massachusetts General Hospital.

She noted that, based on her research, a patient’s platelets need to be inhibited by 30% to get a reasonable decrease in thrombosis. In order to get to this number, she explained, patients may need personalised, different medications. “What we should be doing is testing the blood, determining whether or not you hit a particular level, and then treating accordingly,”

money they made” from performing atherectomies.

The article names one doctor, for example, who it states received US$45 million from Medicare over five years for performing thousands of atherectomies.

Others caught the researchers’ eyes “because a large proportion of their patients who underwent atherectomies had just claudication, raising questions about the necessity of the procedures”.

Hicks is quoted in the article as saying, “It’s concerning that we may be doing unnecessary procedures and spending unnecessary healthcare dollars”.

Marty Makary, a surgeon and researcher at Johns Hopkins and leader of the Global Appropriateness Measures organisation, also comments in the article.

“The moral dilemma that the medical community is now facing is that we can see practice patterns in big data that are inappropriate. Do we have a duty to act?

I think we do,” he is quoted as saying.

The article states that ProPublica used the work of Hicks, Makary and their colleagues as a “springboard” for their analysis, with the aim of answering three “basic” questions: “Which doctors are making the most money off of a single procedure?

Who are they treating? And what is happening to their patients?”

The authors found that about 200 doctors are responsible for a majority of atherectomies conducted across the country, and states that “this small cadre of mostly vascular surgeons, interventional radiologists and cardiologists had earned nearly US$1.5 billion, conducting almost 200,000 procedures”.

A second article digs deeper into the research, looking at how ProPublica and CareSet investigated the overuse of vascular procedures.

The profile of Hicks highlights how she and her

she said.

The presenter mentioned, for example, that men and women require different treatment. “We are undertreating women, even though we think we’re treating them the same.

Because of course our studies have not included that many women, so we haven’t seen this.” The answer? “We need to personalise it,” Dua said.

The presenter noted that her work in this field has been published in the Journal of the American Heart Association (JAHA), but the task now is to translate the data into practice.

In this regard, Dua referenced an ongoing trial she is conducting called TEG-MED. Dua and her team have formed an anticoagulation algorithm based on the 30% figure highlighted in their previous research. The aim now is to work out which patient needs what medication to get to that figure, remarking again that “every patient is slightly different”.

“The future for these patients is very bright,” Dua said in her concluding remarks. “We’re figuring out the coagulation story, we’re starting to understand that there are patients that can be helped with deep venous arterialisation and we’re accepting this new technology, and I really feel that— over time—we don’t have to even say we’re going out on a limb to save a limb, because it’s just going to become our standard of care.”

team faced hostility in response to their work on the topic, including from the podium at scientific meetings.

The title of the article states that Hicks—who “warned of unnecessary, risky vascular procedures”— was labelled a ‘Nazi’ and accused of ‘fratricide’ for doing so.

Society for Vascular Surgery responds

The Society for Vascular Surgery (SVS) has issued a statement addressing these latest reports published by ProPublica.

The SVS informed members that it was aware of the latest ProPublica coverage and remains concerned that such articles, “while addressing an important issue of potential overutilisation and statistical outliers, can also stoke unnecessary fear in the patient population and may contribute to a well-documented under-diagnosis issue, fostering downstream negative outcomes which can be prevented with earlier diagnosis and treatment.”

The statement continued, “It is important to note that in this series of articles the overwhelming majority of providers consistently seem to be practising in accordance with vascular care guidelines, and this deserves acknowledgement.”

The Society pointed to previous “strong” positions it has taken regarding quality standards in the provision of vascular care. The SVS statement stressed that it would continue to advocate “that all providers of vascular care should practise in accordance with quality care and patient safety guidelines, enrol in a registry that meets or exceeds the standards of the VQI [Vascular Quality Initiative], and engage in quality improvement initiatives.”

February 2024 | Issue 101

14 Interview

PROFILE

DANIEL CLAIR

“The future of vascular surgery is incredibly bright,” Daniel Clair (Vanderbilt University Medical Center [VUMC], Nashville, USA) opines in this interview with Vascular News on his career in the field so far. Having always known he wanted to be a physician, Clair is now chair of the Department of Vascular Surgery in the Section of Surgical Sciences at VUMC. He details his keen interest and experience in trialling new innovations and technologies for the betterment of patient outcomes, highlighting in particular his ongoing work on deep vein arterialisation technology for limb salvage. Clair also considers some of the challenges and opportunities currently facing the specialty—pointing towards the future adoption of medical therapies—and advises aspiring physicians to look after their own health and wellbeing in order to be able to meet the demands and responsibilities of a career in medicine.

Why did you decide to pursue a career in medicine and why, in particular, did you choose to specialise in vascular surgery?

I honestly cannot remember a time I did not envision myself as a physician. There are no physicians in my family and my oldest sister is a nurse, but I had always believed I should be a physician. I planned to pursue a career in family practice and return to my home as a family medicine doctor, until I completed a surgery rotation in medical school at the University of Virginia (UVA). Long known for its training of primary care physicians, UVA was my first choice for medical school because of this history, but I truly enjoyed surgery and providing options to reverse urgent problems—a part of medicine I would not have experienced had I pursued a career in family practice.

During my surgery residency, I enjoyed many specialties, but recognised vascular surgeons established long-term relationships with their patients, much like primary care physicians, and I have always enjoyed these relationships with patients. Additionally, at the time I trained I also discovered I wanted innovation to be part of my career.

I considered fellowship training in both minimally invasive surgery and vascular surgery for this reason, but eventually the combination of opportunity for innovation, lasting relationships with patients and the technical detail noted in vascular surgery were the features that attracted me to the specialty and have kept me engaged during my career.

Who were your career mentors and what was the best advice that they gave you?

I have been fortunate to have had a number of mentors over my career including John Mannick, who was instrumental in the establishment of vascular surgery as a separate specialty. He helped me understand vascular patients were the most frail patients in the hospital and that not all these patients could tolerate the large procedures we offered at the time. Anthony (Andy) Whittemore taught me the value of being technically skilled in the craft of surgery and Craig Donaldson and Mike Belkin taught me a great deal about educating vascular trainees. Ken Ouriel and Craig Kent provided insight into leadership and vision, and both taught me that striving for continued improvement would always prove valuable. Additionally, I have learned a great deal from individuals in industry and have seen how important the relationships between industry partners and physicians

are for advancement in the field. Lessons about these critical relationships were taught to me most notably by John McDermott, Bob Mitchell, Simona Zannetti (a surgeon working in industry), Dave Deaton and Peter Schneider, all of whom I view as friends and mentors. And finally, some of my best mentors are former trainees who have taught me learning and teaching are bidirectional. I have been fortunate to have had an extensive list of wonderful trainees who have taught me a great deal, as I hope they have learned from me including John Eidt, Ben Starnes, Rich Cambria, Frank Pomposelli, Sean Lyden, Matt Eagleton, Zak Arthurs and Jocelyn Beach, along with many others. I do not know that there is an individual I have trained, from whom I have not learned something.

What have been some of the most important developments in vascular surgery over the course of your career so far?

Without question, the most important development has been the introduction and adoption of minimally invasive therapies.

Having completed my formal vascular surgery training without any instruction in interventional therapy, my entire surgery and vascular surgery fellowship training included only open surgical procedures.

During my military career, I began working with the radiologists performing angiography and interventional therapies and prior to initiating my surgical career at the Cleveland Clinic Foundation, I was fortunate enough to have Norm Hertzer as my chair who clearly understood the value interventional therapies would bring to patients with vascular disease.

Dr Hertzer allowed me three months to train formally with Bruce Gray, a skilled peripheral interventionalist who was instrumental in providing my training in performing endovascular procedures. Thanks to this preparation, I was able to start my career with over 700 peripheral interventions prior to offering this option to patients. It has been gratifying to see vascular surgeons adopt and embrace these technologies and this approach.

It has strengthened our profession and has made vascular surgery unique in the ability to offer the spectrum of care for patients.

More recently, it has been additionally critical to note that adoption of medical therapies to improve the cardiovascular health of our patients has been an added benefit for vascular specialists, and vascular surgeons have embraced this approach as well. I believe we

will continue to see advances along this front that can reduce the impact of vascular disease on our patients and our society.

What are the biggest challenges currently facing vascular surgery?

FACT FILE CURRENT POSITION 2021–present: Inaugural chair of the Department of Vascular Surgery at VUMC

PAST POSITIONS (SELECTED) 2016–2021: Chairman of the Department of Vascular Surgery at the University of South Carolina (Columbia, USA) 2006–2016: Chairman of vascular surgery at the Cleveland Clinic (Cleveland, USA) 2002–2004: Chief of vascular surgery at Columbia Presbyterian, NY Presbyterian Health System (New York, USA) 1998–2002: Vascular Surgeon at the Cleveland Clinic 1994–1998: Vascular surgeon in the US Air Force

EDITORSHIPS Journal of Vascular Surgery Journal of Vascular Medicine

Vascular surgery faces a number of significant challenges, including the training paradigm and the need to address the current method of training, the lack of adequate numbers of vascular surgeons, the increasing need for vascular care as the population ages—with the comorbid conditions leading to vascular disease continuing to increase—and the amputation crisis facing the global community.

While these challenges will not be easy to address, there are a variety of approaches that can be taken to improve each of these, and therein lie the opportunities for the community of vascular surgeons. Vascular surgery is a relatively young specialty and as a maturing specialty, there are areas where we will need to look to other specialties for insight into methods to deal with these challenges.

Orthopaedic surgery, ophthalmology and neurosurgery as well as cardiology, gastroenterology and oncology are all areas that have matured as specialties in ways that vascular surgery can take lessons from. The future for vascular surgery is incredibly bright and the opportunity is incredible. We have an excellent record of embracing technology, and helping to evaluate this technology to allow continued improvement in care. What I have seen in my own career is incredible and I am confident this has led to improvements in outcomes for our patients and I look forward to this progress continuing.

You are co-principal investigator of the PROMISE trials, which are designed to assess the LimFlow system. How do you hope this trial will change practice for patients with ‘no-option’ chronic limbthreatening ischaemia (CLTI)?

The PROMISE trials have documented an ability to salvage limbs for patients previously relegated to amputation. My hope is that this will enhance options for patients and will continue to ‘move the needle’ toward limb salvage for more patients. While not all amputations are preventable, it is clear we can provide more limb salvage than we are currently. Any practice that really wants to provide limb salvage options needs to have this method available and the hope would be that this would reduce the number and rate of amputations from vascular disease. In addition, as with other technologies, I believe we are just seeing the first steps in the use of this approach and there will be increases in the application of and use of this approach.

Amputation is an incredibly high price for a patient, their family and our society to pay— we should all be seeking ways to keep patients whole, functional and ambulatory.

Could you outline one of your most memorable cases?

In a career spanning more than 30 years, there

Issue 101 | February 2024

alisonlang.com

Interview 15

are a number of cases that are memorable, but perhaps one of my more memorable cases was the treatment of a large juxtarenal aneurysm with associated bilateral iliac artery aneurysms in a 93-year-old gentleman with contained rupture. He also had bilateral renal stenosis, mild renal insufficiency, and underlying pulmonary disease. This patient would never have survived an open operation. The case was treated with a hybrid procedure, using bilateral renal stents placed so the aorto-uni-iliac stent graft could be placed more proximally in the aorta; a cross femoral graft and an endovascular external to internal iliac artery bypass to maintain hypogastric perfusion in one hypogastric artery while excluding a large common iliac aneurysm—the contralateral internal iliac artery required embolisation; all of this performed after being flown to another country to perform the procedure on a patient of whom I had only seen non-contrast computed tomography (CT) scan images.

Thankfully, this patient did well and survived nearly another 10 years. This procedure,

performed over 20 years ago, was something that could never have been even considered when I entered my career, but just 10 years after my training completed, a new era of therapy introduced by Juan Parodi provided a solution that has revolutionised the care of patients. We should all be grateful to Dr Parodi for his persistence and his courage in pursuing this innovative therapy.

What advice would you give to someone looking to start a career in medicine?

Medicine is a career that will require your time and your commitment. It will give you an incredible opportunity to provide for your patients in ways you cannot imagine.

The gratitude you receive from patients and families is rewarding and this will provide you with a wonderful sense of purpose. It is your responsibility to provide the best care you can for your patients and to assure you commit to caring for them as you would a member of your family. In order to do this effectively, you will need to care for yourself and for your

"While not all amputations are preventable, it is clear we can provide more limb salvage than we are currently.”

family and assure you get the time you need and those close to you get the time they need as well.

It is more rewarding than you can ever imagine, but more demanding than you will understand until you are there. Plan time with family and for yourself throughout your career to ensure you have the energy to give to your patients what they deserve.

What are your hobbies and interests outside of medicine?

I have always had an interest in physical activity and I try to work out at least four to six days per week. I also enjoy playing golf and tennis with my wife Patty who has supported me through my career.

My other interest besides these physical activities is reading. I listen to books while working out, travelling to work and even while walking in the hospital. In this regard, I enjoy science fiction, biographies and autobiographical works, and I also enjoy reading about science outside of medicine.

February 2024 | Issue 101

16 News

PERIPHERAL

One-year results suggest specialist CLTI clinics are viable alternative to emergency admission “SPECIALIST CLTI [CHRONIC limb-threatening ischaemia] clinics are inclusive, safe, effective, efficient, and alleviate pressure on vascular units,” Assad Khan (Leeds Vascular Institute, Leeds, UK) stated at the 2023 Vascular Society of Great Britain and Ireland’s (VSGBI) annual scientific meeting (22–24 November, Dublin, Ireland).

By way of background, Khan noted that the incidence of CLTI is predicted to rise, and that the number of emergency CLTI admissions to hospital are rising year on year, according to the latest Hospital Episode Statistics data from NHS Digital. The VSGBI estimates treatment of CLTI accounts for over 50% of the emergency vascular workload in the UK. Khan stated that there is single-centre evidence available to indicate that specialist clinics are beneficial for CLTI patients. He referenced some of his own work from a different centre, published in 2020, and another study published in 2021, in which Andrew Nickinson (Leicester, UK) and colleagues outline how the introduction of a vascular limb

salvage service at the Leicester Vascular Institute improved one-year amputation outcomes for patients with CLTI. Khan explained that all CLTI patients admitted to the Leeds Vascular Institute during a one-year period (28 March 2021–28 March 2022), counting those who had been revascularised, were included in a prospective, observational cohort study. Patients with diabetic foot infection and acute limb ischaemia were among those excluded from the research. The presenter shared that a total of 391 patients were enrolled in the study, comprising 205 inpatients and 186 outpatients, however outcomes were focused on the patients undergoing revascularisation (128 amongst the inpatient group and 149 in the outpatients). The average age, frailty (as determined by Rockwood Clinical Frailty Score) and smoking status exhibited no statistically significant difference between groups.

Looking at the revascularisation strategies used, Khan noted that 68% of patients in the inpatient group underwent endovascular intervention

SCAI, SIR, and SVS jointly publish proceedings from multispecialty peripheral IVUS roundtable Proceedings from an expert consensus roundtable that discussed the benefits of intravascular ultrasound (IVUS) in lower extremity revascularisation procedures were released in the Journal of the Society for Cardiovascular Angiography & Interventions (JSCAI), Journal of Vascular and Interventional Radiology (JVIR), and Journal of Vascular Surgery: Vascular Insights.

T

he roundtable focused on the current challenges in diagnosing and treating lower extremity revascularisation, knowledge and data gaps, and the potential role of IVUS in addressing these challenges. Experts shared their insights and experiences from the fields of interventional cardiology, interventional radiology, and vascular surgery. The expert consensus meeting was convened

by SCAI and co-sponsored by: American Vein and Lymphatic Society (AVLS), American Venous Forum (AVF), Society of Interventional Radiology (SIR), Society for Vascular Medicine (SVM), and Society for Vascular Surgery (SVS).

compared to 64% in the outpatient group. Sixteen per cent of patients were treated with a hybrid approach in the inpatient group compared to 15% in the outpatient group, and 15% were treated surgically in the inpatient group, compared to 21% in the outpatient group with no statistically significant difference. Time to definitively image was lower in the inpatient group than in the outpatient group, at three days compared to 19. The same was true for time to revascularisation, at six days and 39 days, respectively.

Khan acknowledged some limitations, including the fact that there were more patients with Wound, Ischaemia, foot Infection (WIfI) stage 4 in the inpatient group compared to the outpatient group (38 vs.

21) who are significantly more likely to be amputated.

Therefore, a subgroup analysis of patients with WIfI Stage 2 and 3 disease (inpatients n=88, outpatients n=125) was performed.

Reporting 30-day subgroup outcomes for outpatients relative to inpatients when adjusted for age, WIfI Stage, sex and frailty, Khan detailed that the odds ratio (OR) for major amputation was 0.141 (p=0.01), for discharge home was 6.950 (p=0.001), for major adverse limb events (MALE) was 0.407 (p=0.01) and for major

“Improvements in outcomes following peripheral vascular intervention have lagged compared to other endovascular treatments, such as percutaneous coronary intervention. Both clinical experience and evidence support the greater use of peripheral IVUS to reduce adverse events and extend the patency of our lower extremity revascularisation procedures.

By gathering experts from different specialties, we aimed to foster collaboration and exchange ideas to improve patient care for peripheral IVUS,” said Eric A Secemsky (Beth Israel Deaconess Medical Center, Boston, USA) lead author of the document. “The roundtable provided a unique opportunity to identify knowledge gaps and discuss how IVUS can enhance our understanding and treatment of peripheral arterial and deep venous pathology.”

Lower extremity revascularisation is a critical procedure used to restore blood flow to the legs and feet in patients suffering from peripheral arterial disease (PAD) and deep venous pathology. It is estimated that millions of people worldwide are affected by these conditions, which can lead to severe pain, non-healing wounds, and even limb loss if left untreated. Although angiography is the dominant imaging modality in revascularisation, it has inherent limitations. IVUS is a minimally invasive imaging technique that allows physicians to visualise the inside of blood vessels in real-time.

It provides detailed information about the vessel wall, plaque composition, and blood flow characteristics, enabling more accurate diagnosis and treatment planning.

During the roundtable, participants highlighted the potential of IVUS in guiding revascularisation procedures, such as angioplasty and stenting, to optimise outcomes for patients. They also

adverse cardiovascular events (MACE) was 0.167 (p=0.038).

Khan then reported that at 12 months, rates of amputation-free survival (74% vs. 53%) and major amputation (7% vs.

28%) were better amongst outpatients.

After adjusting for age, sex, WIfI stage and frailty, the OR for amputation-free survival was 2.565 (p=0.001) and for major amputation was 0.259 (p=0.001) for outpatients relative to inpatients.

There was no statistically significant difference in mortality between the two groups (18% vs. 23%) with an OR for mortality of 1.035 (p=0.913) for outpatients relative to inpatients. He noted that the difference in amputationfree survival was driven by amputation reduction rather than a survival benefit.

Finally, Khan shared that the length of stay was longer in the inpatient group than the outpatient group, at 17 days compared to one, and that the number of bed days were higher in the inpatient compared to the outpatient group (3,798 vs.

716). Bed costs (£1,188,744 vs. £224,108), costs per patient (£22,983 vs. £9,283) and total operational costs (£632,520 vs. £191,775) were also higher in the inpatient group.

These findings led Khan to conclude that specialist CLTI clinics might be a viable alternative to emergency admission.

Treatment of CLTI accounts for over

50%

of the emergency vascular workload in the UK

emphasised the need for further research and evidence to support the integration of IVUS into routine clinical practice.

“Vascular diseases are complex conditions requiring team-based care, research and information sharing to ensure that patients have access to appropriate, quality care for their condition,” said SIR President Alda L Tam (MD Anderson Cancer Center, Houston, USA). “Ongoing collaboration among these specialties is paramount to improving outcomes for patients worldwide.”

The roundtable concluded with a commitment to ongoing interdisciplinary collaboration and knowledge sharing among physicians. Participants agreed that treatment standards, formal training programmes and global quality metrics remain necessary to improve patient care.

The roundtable provided a unique opportunity to identify knowledge gaps and discuss how IVUS can enhance our understanding and treatment of peripheral arterial and deep venous pathology.”— Eric A Secemsky

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February 2024 | Issue 101

18 News

PERIPHERAL

First presentation of complete patientlevel dataset on paclitaxel and death that helped sway the US FDA

L-R: William Gray, Sahil Parikh and Peter Schneider

Data from a patient-level meta-analysis—a factor in the US Food and Drug Administration’s (FDA) recent change of position on the use of paclitaxel-coated devices to treat peripheral arterial disease (PAD)—were made public for the first time at TCT 2023 (23–26 October, San Francisco, USA).

T

he analysis led investigators to conclude that there is no association between mortality risk and paclitaxel-coated device exposure or dose, and should provide reassurance to patients, physicians and regulators on the safety of paclitaxel-coated devices, they say.

The release of the data, which was also published in The Lancet, draws a line in the sand over the question of the safety of paclitaxel, which is used in peripheral interventions to prevent restenosis, after data from a summarylevel meta-analysis put forward in 2018 pointed to an increased risk of death at two and five years following the use of paclitaxel-coated devices in the femoropopliteal artery.

William A Gray (Lankenau Heart Institute, Wynnewood, USA) told TCT attendees that the analysis provides the most complete and current followup data of pivotal studies associated with FDA-approved paclitaxel-coated devices and represents the most complete patient-level analysis to date, or likely to be available in the future.

Gray presented the findings on behalf of an independent physician steering committee, comprising Sahil Parikh (Columbia University Irving Medical Center, New York, USA), Peter Schneider (University of California San Francisco, San Francisco, USA), Christopher Mullin and Tyson Rogers (both North American Science Associates [NAMSA], Minneapolis, USA), who were enlisted by the regulator and industry to dig into the final and updated patient-level datasets and address limitations of prior paclitaxel meta-analyses. Funding for the study came from BD, Boston Scientific, Cook, Medtronic, Philips, Surmodics and TriReme Medical, though the funders of the study had no role in its design, data analysis, data interpretation, or writing of the report,

but did provide patient-level data for the analysis, which was independently conducted.

The use of paclitaxel-coated devices for the treatment of PAD dropped by as much as 50% due to changes in practice patterns worldwide, Gray said, which was in response to the FDA’s 2019 statement that use of paclitaxelcoated balloons and paclitaxel-eluting stents was “potentially associated with increased mortality”. This change in position came after a meta-analysis from Konstantinos Katsanos (University of Patras, Patras, Greece) et al had first raised the spectre of a mortality risk.

The FDA removed the red flag in July this year, stating that “additional data from the pivotal randomised controlled trials (RCTs) [have] become available” in a letter to healthcare providers in which it set out the decision.

To inform this decision, Gray and his co-investigators analysed randomised trials that evaluated FDA-approved paclitaxel-coated devices versus uncoated devices for the treatment of femoropopliteal artery disease, looking primarily at the mortality risk on an intention-to-treat basis, with key secondary analyses including dose/ mortality and covariate interactions.

Data from 10 trials were included, encompassing 2,666 participants over a median follow-up of 4.9 years. Oneyear follow-up was available in 98.7% of evaluable participants and five-year follow-up in 95%, which Gray noted represents an additional 3,355.5 patient years since a 2020 analysis by VIVA Physicians, in which investigators identified an absolute 4.6% increased mortality risk associated with paclitaxel-coated devices, albeit demonstrating a weaker mortality signal than was initially reported in December 2018 by Katsanos et al.

Results of the latest analysis presented by Gray and published in The

Lancet demonstrated an overall hazard ratio (HR) for the intention-to-treat population of 1.14 (95% confidence interval [CI] 0.93–1.40). In post-hoc analyses assessing the proportional hazards assumption, there was no evidence the assumption was violated.

HRs for individual studies ranged from 0.32 to 1.52, and there were no studies in which the CI did not include the null value of 1. The HR for the astreated analysis was 1.13 (0.92–1.39).

Furthermore, the as-treated crossover analyses did not show a significant difference in deaths between the paclitaxel-coated and control groups, with a HR of 1.07 (0.87–1.31) when late crossovers were censored, and 1.04 (0.84–1.28) in the time-varying analysis of late crossovers. Examination of late crossover using iterative parameter estimations also failed to detect a significant effect on deaths.

Speaking to Vascular News following the presentation of the updated dataset at TCT 2023, Gray said that the new data “almost certainly” resolve the safety question over the use of paclitaxel-coated devices for the treatment of PAD. “There will be very few, if any, paclitaxel versus non-paclitaxel femoropopliteal trials, so the data are what we have today, and they are not likely to be enhanced any further,” he said. “The data that we have are the most complete data that we are going to get. The follow-up is 95%, a lot of credit [goes] to industry for going out and getting those data, it is really important as part of the larger effort.

“What I would say is that this is a three-year effort, it involved the FDA,

and with regulatory bodies all over the geography, but especially with FDA, [which] has been extremely collaborative and has been all about problem solving since the beginning of this issue.”

“Here we have probably the most complete dataset that will be feasible from the randomised controlled trials,” commented Parikh. “We looked at the overall percentage of patients identified with vital status at five years, and it was 95% of the total cohort of almost 2,700 patients. I think it will be hard to find a more complete dataset at this level of detail.”

More importantly, added Parikh, was the opportunity to conduct crossover analyses.

“We are identifying exposure to paclitaxel in any way, to the maximum extent possible, and, with each subsequent iteration of the analysis, our findings showed a closer and closer point estimate to no hazard at all, to unity,” he said. “That really emphasises that going the extra mile to identify every exposure to paclitaxel, in this case most often with a contralateral limb intervention or reintervention, was the appropriate approach to adjudicate paclitaxel exposure and its risk.”

Lessons to be learned

Asked for his reflection on the lessons learned from the controversy, Gray summarised comments by Michael Conte (University of California San Francisco, San Francisco, USA) and Eleni Whatley of the US FDA, who spoke during the same TCT session at which he delivered the updated meta-analysis.

There will be very few, if any, paclitaxel versus non-paclitaxel femoropopliteal trials, so the data are what we have today, and they are not likely to be enhanced any further.” industry, NAMSA, physician scientists and so on, and it would be very difficult to imagine recapitulating that effort and getting a different answer, or even having any reason to do that, given that the dataset that I just described is unlikely to change.”

“The most important takeaways are that: Number one, we [have] learned a tremendous amount about how future studies should be planned, so that we do not go down a blind alley again to be fooled by a summary level metaanalysis,” Schneider told Vascular News, reflecting on the takeaways from the research.

“The second thing is that this was a tremendous effort to resolve this problem, and that included collaboration like we have never had before between physicians of different specialties in different parts of the world, with industry

“Basically, we have to do better follow-up and to do better trial design in order to understand what medical therapy is being given to the patient because that has an impact on mortality,” he said. “We have to understand better what the crossover rates are in any therapeutic [strategy]. If someone is getting a therapeutic and we are not counting the crossovers, we are missing lots of the effect, potentially.

“Dr Conte made the point which is that the follow-up time periods for the pivotal trials were probably too short, and if they are not going to be lengthened—and I understand why we do not necessarily want to do that, to speed the devices to the market—then we have to have more robust post-market surveillance.

So, there are lots of things that we have learned, I think all of them are very much positive, and I know they will be incorporated in trials going forward.”

Issue 101 | February 2024

News 19

PROMISE II 12-month data show durable outcomes with the LimFlow system in no-option CLTI patients ONE-YEAR RESULTS FROM THE PROMISE II US pivotal trial demonstrate the durability of outcomes of transcatheter arterialisation of the deep veins (TADV) using the LimFlow system (LimFlow) and that the procedure is safe and reproducible.

Daniel Clair (Vanderbilt University Medical Center, Nashville, USA) recently presented the new data for the first time at VIVA 2023 (30 October–2 November, Las Vegas, USA). He reported a limb-salvage rate of 69% at 12 months, among other key results, in patients who have chronic limb-threatening ischaemia (CLTI) with no suitable endovascular or surgical revascularisation options.

Clair, who served as co-principal investigator of the trial alongside Mehdi Shishehbor (University Hospitals Harrington Heart & Vascular Institute, Cleveland, USA), noted that the new data are an extension of the six-month PROMISE II results that were presented at VIVA 2022. Following publication of these results in the New England Journal of Medicine (NEJM), the US Food Administration (FDA) approved the LimFlow system in September of 2023.

At 20 centres without roll-ins across the USA, 105 no-option CLTI patients were enrolled in a non-randomised manner. All enrolled patients had Rutherford class 5 or 6 disease and were deemed by an independent committee of experts to be ineligible for endovascular or surgical procedures to restore blood flow.

The median age of the patient cohort was 70 years, two-thirds were male, and one-quarter were Hispanic or Latino. Most patients presented with pre-existing

Daniel Clair presents PROMISE II results at VIVA 2023

comorbidities, including diabetes, hypertension, dyslipidaemia, and a history of intervention on the index limb. All patients presented with a non-healing ulcer or frank gangrene and were classified as either Rutherford class 5 or 6.

Clair revealed at VIVA that, at one year, limb salvage was maintained in 69% of patients. “You can see—and this has been noted before—a drop-off through the first three months, but those who were able to keep their limbs to that point usually did significantly well over time,” he commented.

In addition, the presenter shared that the average wound area was 0.2cm2 at 12 months. “You are talking about minimal wounds that these patients had when they did have remaining wounds,” he said. Clair also noted an average pain score (scale 0–10) of 1.4 at

TRANSCEND 36-month data “continue to demonstrate safe and effective performance” of SurVeil DCB

P

eter Schneider (University of California San Francisco, San Francisco, USA) recently presented 36-month data from Surmodics’ TRANSCEND clinical trial at the VEITHsymposium 2023 (14–18 November, New York, USA).

The TRANSCEND trial is a prospective, multicentre, singleblind randomised controlled trial to assess the safety and efficacy of the SurVeil drug-coated balloon (DCB; Surmodics) versus the IN.PACT Admiral DCB (Medtronic) for treatment of superficial femoral and proximal popliteal artery lesions. A total of 446 patients were randomised to either the low-dose paclitaxel (2.0µg/mm2) SurVeil DCB (n=222) or the high-dose (3.5µg/mm2) paclitaxel IN.PACT Admiral DCB (n=224) at 65 sites in the USA, Australia, Austria, Belgium, Czech Republic, Germany, Italy, Latvia and New Zealand.

The primary efficacy endpoint is 12-month primary patency, defined

as freedom from binary restenosis or clinically driven target lesion revascularisation (CD-TLR). Primary patency was comparable between the SurVeil DCB and IN.PACT Admiral (82.2% vs. 85.9%). The primary safety endpoint is freedom from device- or procedure-related death within 30 days and above-ankle amputation or CD-TLR within 12 months, which also demonstrated comparable outcomes between SurVeil DCB and IN.PACT Admiral DCB (91.8% vs. 89.9%).

Non-inferiority was tested using a multiple imputation approach at one-

SurVeil DCB is a bestin-class, highquality treatment option for our PAD patients.”

12 months, representing a “significant reduction” from an average of 5.3 at enrolment. More than half of the patients were classified as Rutherford class 0 at one year.

In addition, Clair reported pooled results from PROMISE I and PROMISE II. “The PROMISE I trial did not include dialysis patients and did not include COVID deaths, but other than that these two trials were very similar,” he remarked. In the pooled analysis, the presenter noted an overall survival rate of 85%, a limb-salvage rate of close to 75%, and a 63% rate of amputation for this population.

“In conclusion, the [US] FDA has approved this product with the six-month data that have been published in the [NEJM], and these 12-month data extend upon that and show that this is a durable, sustainable outcome,” Clair summarised. He added that the outcomes are consistent even with new users.

“The procedure is reproducible and generalisable— most operators in PROMISE II had essentially no experience with this technique—and I continue to believe that as we gain experience with this, over time we will learn more and do better as we move forward.”

“I am very proud to be able to present this information and happy with where we are headed with this complex group of patients,” he said in closing.

The procedure is reproducible and generalisable—most operators in PROMISE II had essentially no experience with this technique.”

sided alpha 0.025.

Data demonstrate the SurVeil DCB is non-inferior to the IN.PACT Admiral DCB with regards to both safety and efficacy while delivering a substantially lower drug dose, a Surmodics press release reports.

Both the SurVeil and IN.PACT Admiral DCBs utilise coatings with the antiproliferative drug paclitaxel.

However, the IN.PACT Admiral DCB has a 75% higher drug load of paclitaxel (3.5μg/mm2) than the SurVeil DCB, which has a 2.0μg/mm² drug load.

Patient outcomes are being collected at one, six, 12, 24, 36, 48, and 60 months. Intermediate-term (36-month) secondary outcomes included CDTLR, major target limb amputation (TLA), thrombosis at the target lesion, and historical major adverse events.

A total of 352/363 (96.97%) patients completed their 36-month visit.

Surmodics states that the SurVeil DCB, which previously demonstrated noninferior primary safety and effectiveness outcomes through 12 months with a lower paclitaxel dose, continues to demonstrate similar outcomes at

intermediate-term follow-up of 36 months compared with the highdose IN.PACT Admiral DCB in the treatment of patients with symptomatic peripheral arterial disease (PAD) caused by stenosis of the femoral and/ or popliteal arteries. Results at 36 months for SurVeil versus IN.PACT Admiral were statistically comparable, including CD-TLR (20.3% vs. 19.5%; p=0.897), major TLA (0.0% vs.

0.5%; p=1), thrombosis at the target lesion (0.6% vs. 0.0%; p=0.475), and historical major adverse events (MAEs; 28.6% vs. 28.5%; p=1).

“The TRANSCEND 36-month data continue to demonstrate safe and effective performance of the SurVeil DCB. SurVeil DCB is a best-in-class, high-quality treatment option for our PAD patients utilising a next-generation surface coating with a lower dose of paclitaxel compared to IN.PACT Admiral DCB,” said Schneider.

Peter Schneider

February 2024 | Issue 101

20 News

AORTIC

US Aortic Research Consortium maps out F/BEVAR preoperative risk factors for one-year mortality in complex AAAs, TAAAs A series of preoperative risk factors—including currently smoking, chronic kidney disease (CKD), congestive heart failure (CHF), aneurysm size greater than 7cm, more advanced age (75 or over), Crawford extent I–III thoracoabdominal aortic aneurysms (TAAAs), known chronic obstructive pulmonary disease (COPD), and anaemia at baseline—were found to be predictive of one-year mortality among patients undergoing fenestrated and branched endovascular aneurysm repair (F/BEVAR) for complex AAAs and TAAAs with custom-made devices.

T

hat is the key finding from one of the latest papers to come out of the US Aortic Research Consortium (US ARC) of investigational device exemption (IDE) presented at the 2024 Southern Association for Vascular Surgery (SAVS) annual meeting (24–27 January, Scottsdale, USA).

The 10-centre, more than 3,000-patient research conglomerate aims to use the data generated to create a risk stratification calculator to help inform a preoperative decision-making process that balances risk of aneurysm rupture if no intervention takes place, and mortality risk at one year if the disease is operated upon, Adam Beck, a US ARC investigator and vascular surgery division director at the University of Alabama at Birmingham in Birmingham, USA, told Vascular News ahead of the SAVS 2024 meeting.

“The typical discussion when we are in clinic talking to patients about whether or when they should repair their aneurysm always focuses on the risk of rupture,” he said. “And that risk of rupture is usually put into the context of annual rupture risk. We did this project because we wanted to give a counterpoint to that risk of rupture. That was the idea behind this one-year mortality risk. So, you can say, ‘This is the risk of doing nothing, and here is the risk of doing something,’ in the setting of the patient’s overall state of health and quality of life.”

The US ARC

is a

Operative mortality can be very low—from 1–2%—depending on the extent of the aneurysm and complexity of the repair, Beck observed. “But the mortality when you go out to a year can be much higher than that. So, something is happening to these patients after they get repaired. It’s not rupture of their aneurysm. Many of them are dying of their other medical comorbidities.”

The US ARC researchers looked at the full range of preoperatively available risk factors—gender, race, age, coronary disease, CHF, emphysema, cerebrovascular disease, diabetes, renal disease, hypertension, as well as both smoking and preoperative functional status. They were stratified

by Crawford extent of their aneurysm: one complex

Risk of rupture is usually put into the context of annual rupture risk. We did this project because we wanted to give a counterpoint to that risk of rupture.”

10-centre

more than

3,000-patient research conglomerate

AAA (juxtarenal/suprarenal) and two separate TAAA groups—one comprising Crawford type IV and V and the other the particularly high-risk extent I–III group, Beck explained.

“The things that we found that were predictive of one-year Adam Beck mortality in a multivariable Cox regression was if they were a current smoker, if they had CKD, CHF, a very large aneurysm (greater than 7cm), more advanced age (75-plus), extent I–III TAAAs, patients with known COPD, and those who were anaemic at baseline,” he said.

“The aneurysm size is a tough one. That one always falls out in an analysis like this: the bigger your aneurysm, the higher your risk of one-year mortality. It’s an interesting thing because the bigger your aneurysm, the more likely we are to offer you a repair—even in the setting of higher-risk patients, because we’re weighing that risk-benefit with rupture.”

During SAVS 2024, the research team broke down what the risk looks like in their predictive model by increasing risk factors. The risk calculator the US ARC investigators hope to generate would enable individual patient data to be plugged in to gauge their one-year mortality risk.

“Hopefully this could be something that will allow you to discuss with the patient in clinic and say, ‘Here is your risk of rupture, and here is your risk of mortality at one year. I think that it makes sense to proceed with your repair.’ Or you could say, ‘It really doesn’t make sense at your current size for us to put you at the risk of the operation,’” explained Beck.

“This could also help you with your discussions about smoking cessation. If we could show patients on our phone apps and say, ‘This is your risk of mortality at a year with you being a current smoker. If I take this risk factor out, here is your risk factor at one year, and it will be a sizeable difference.’ I think that will really help that discussion with the patient and our clinical decision-making.”

Further down the road, US ARC is set to continue building on its body of work with additional analyses in areas such as target-vessel outcomes based on type of stent graft used, the impact of aortic aneurysm sac behaviour after repair, the impact of renal insufficiency on outcomes, and the impact of endoleaks on mortality. The group has also recently completed a pilot study for a randomised controlled trial (RCT) for prophylactic spinal drains in patients with extent I–III TAAAs. The latter particularly excites Beck owing to his long-standing interest in preventing spinal cord ischaemia as a complication of complex aortic aneurysm repairs.

Another recent development saw US ARC include aortic arch procedures in its registry. “A few of the centres are capturing data for their endovascular aortic arch reconstructions,” Beck noted. “This is still in its infancy, but we’ll have some consortium data to publish in the next year or two, once we have more patients.”

Despite being only about six years old, US ARC is having a big impact on evolving the arena of complex repair of TAAAs and AAAs, Beck said. “In our group, we have each changed our practices based on our publications,” leading to quality improvement, he added. “I’m biased because of my personal academic interests, but I think if we can actually get a [large, nationwide] RCT going for spinal cord ischaemia, that would be one of the biggest contributions that we could make to the aortic surgery world. It will take a few years to enrol the number of patients we will need, so successfully initiating the trial may be one of our next big landmarks.”

Issue 101 | February 2024

News 21

Gore receives US FDA approval for breakthrough endovascular device in complex aortic aneurysms GORE HAS ANNOUNCED US Food and Drug Administration (FDA) approval for the Gore Excluder thoracoabdominal branch endoprosthesis (TAMBE), which the company states is the first off-the-shelf endovascular solution for the treatment of complex aneurysmal disease involving the visceral aorta.

A press release details that US physicians have had limited options for treating patients with aortic aneurysms involving the visceral branch vessels, with the current standard of open surgical repair being complex and associated with a high rate of mortality and morbidity. It continues that existing options for a minimally invasive approach are limited to products not designed for this purpose or custombuilt devices—when and if the patient’s anatomy qualifies them—which can delay treatment due to manufacturing time.

“Until now, endovascular treatment options were limited as alternatives to open surgical repair,” said Mark A Farber (UNC School of Medicine, Chapel Hill, USA), national principal investigator. “TAMBE is an innovative

first step forward that enables us to provide care that’s both effective and timely for complex aneurysm repair.”

TAMBE is an implantable branched device designed for use in patients with thoracoabdominal aortic aneurysms (TAAA) and high-surgical risk patients with pararenal aortic aneurysms (PAAA) of the aorta using an endovascular approach in which the physician guides the device through arteries in the groin and arm via small incisions. Using established imaging techniques, the physician deploys the device to seal off the aneurysm, allowing blood to flow directly through the endoprosthesis.

Because the disease frequently spans adjacent visceral vessels, TAMBE has four built-in, pre-cannulated internal portals to facilitate placement of bridging stent grafts into the visceral arteries perfusing the internal organs within the abdomen.

“At Gore, we continue to pioneer endovascular solutions for physicians and their patients,” said Willy Davison, Gore global aortic business leader. “We look forward to this new technology expanding our portfolio as it becomes available in the coming months.”

Gore Excluder thoracoabdominal branch endoprosthesis (TAMBE)

The modular TAMBE incorporates a newly designed aortic component with components of other commercially available devices including, Gore Excluder iliac branch endoprosthesis iliac branch component, Gore Viabahn VBX balloon expandable endoprosthesis and the Gore Excluder AAA endoprosthesis contralateral leg endoprosthesis. Together, these components create a complete off-theshelf solution for minimally invasive endovascular repair.

Expected to become available in June 2024, TAMBE builds upon the proven performance of the GORE EXCLUDER Device family, which has been used to treat over 450,000 patients. With over 25 years of worldwide clinical experience, the Gore Excluder AAA endoprosthesis is the most studied

endovascular aneurysm repair (EVAR) device, numbering more than 1,500 peer-reviewed publications to date.

TAMBE is an innovative first step forward that enables us to provide care that’s both effective and timely for complex aneurysm repair.”

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February 2024 | Issue 101

22 News

Vascular surgeon scientist-led consortium secures €6 million in Horizon Europe funding to develop sustainable alternative to contrast CT imaging The European Union Horizon Europe, with joint funding from UK Research Innovation, has awarded the NetZeroAICT Consortium €6 million in funding to develop a novel artificial intelligence (AI)-based computed tomography (CT) technology that has the potential to promote climate neutral and sustainable healthcare.

THE INTERNATIONAL, TRANSDISCIPLINARY NetZeroAICT Consortium is led by Regent Lee, a vascular surgeon scientist at Oxford University Hospitals NHS Foundation Trust and associate professor of vascular surgery at the University of Oxford (Oxford, UK). He is a current UK Research Innovation future leaders fellow.

According to the multidisciplinary group—which further includes Vicente Grau, professor of engineering science at the University of Oxford—the new technology (CT Digital Contrast) can make CT scans

“safer, faster, more equitable and more sustainable”. to move forward with development of the technology.

Alongside Lee, there are a number of other vascular Lee anticipates that the team will face some challenges surgeons taking part in the project, including Matt along the way. He highlights, for example, that clinical Brown (University of Leicester, Leicester, UK), acceptance may take time. “What we are proposing Fabien Lareyre (University Hospital of Nice, to do is quite radical,” he said. “Essentially, Nice, France), Grzegorz Oszkinis (University we are proposing a complete change of how Hospital in Opole, Opole, Poland), and radiology services can be delivered, and there Edwaldo Joviliano (University of Sao Paulo, will be questions and reluctance amongst the Sao Paulo, Brazil). clinicians to get used to this new way of looking A press release by the University of Oxford at images.” He likened the task of launching the states that the Horizon Europe award funding technology as “almost like trying to introduce Regent Lee a new language into the profession”. Lee also will accelerate scientific development, clinical validation and subsequent regulatory approval mentioned that patients may be fearful of using of CT Digital Contrast. It continues that the funding an entirely new method of imaging to treat them. will harness the comprehensive collective expertise In a press release announcing the new funding, of the 20 partners across academia, healthcare Lee commented on the wider significance of the and industry. consortium’s work: “The combined NetZeroAICT Speaking to Vascular News in light of the funding Consortium expertise will enable us to develop award, Lee provided a high-level description of how and deploy trustworthy ‘green’ AI software as a the technology works. Essentially, he explained, the medical device with the ultimate goal to reduce the idea is to use AI to enhance non-contrast CT scans environmental footprint from CT imaging. European with the aim of getting the equivalent outcomes to a patients will have access to safer, faster, equitable and contrast scan. He elaborated: “When you do a contrast sustainable healthcare delivery while the healthcare CT scan, you typically go through the scan twice. The systems strengthen their alignment with the European first time, you have a non-contrast CT, and then, based Green Deal. This is a new era of translational research. on that non-contrast CT, the radiologist will calculate In addition to improving patients’ health, our aspiration how tall you are etc. and calculate the timing of the is to improve planetary health for future generations.” injection of the contrast. Next, the patient gets scanned a second time to get the contrast-enhanced CT. What we propose is that with AI, we would only require the first non-contrast CT scan. We can extract high-level information from the non-contrast CT scan using AI and overlay where contrast should be on the native non-contrast scan and display it as a digital contrast enhanced scan, without the need for the second scan.”

The funding received will allow for the researchers

We are proposing a complete change of how radiology services can be delivered.”

Midterm CARAS study results show cerebral ischaemic event incidence “should not be underestimated” The final publication of midterm results from the observational CARAS study suggest that cerebral ischaemic event (CIE) incidence in asymptomatic carotid stenosis patients “should not be underestimated”, so say authors Rodolfo Pini (University of Bologna, Italy) and colleagues, relaying these findings in the Journal of Stroke and Cerebrovascular Diseases.

T

he authors further conclude that plaque progression and contralateral stenosis are among factors that may serve as primary predictors of CIEs, as per the results of their midterm analyses—which were initially presented at last year’s Vascular Annual Meeting (VAM; 14–17 June 2023, National Harbor, USA).

“Carotid endarterectomy [CEA] in patients with asymptomatic carotid stenosis remains a subject of debate,” Pini and colleagues initially state.

“Current recommendations are based on randomised trials conducted over 20 years ago and improvements in medical therapies may have reduced the risk of CIEs. This study presents a midterm analysis of results from an ongoing, prospective, observational study of [asymptomatic carotid stenosis] patients to assess their CIE risk in a real-world setting.”

CARAS is a prospective, observational study of a cohort of asymptomatic patients with >60%

carotid stenosis—as per criteria from the original NASCET trial—identified in a single duplex ultrasonography vascular laboratory. Short life expectancy and absence of signs of plaque vulnerability are among the factors cited by the authors for patients in the study not being considered for CEA. The study’s primary endpoint is to assess CIEs ipsilateral to asymptomatic carotid stenosis, including strokes, transient ischaemic attacks (TIAs), and amaurosis-fugax, along with plaque progression rate and patient survival.

Patient enrolment took place from January 2019 to March 2020, with a sample size of 300 patients being targeted and a five-year follow-up scheduled. CARAS ultimately included a total of 307 patients (average age, 80 years; 55% male), of whom 61 (20%) had contralateral stenosis >60% and some 77% were on best medical management.

At a mean follow-up of 41 months, seven ipsilateral strokes and nine TIAs

occurred, resulting in a total of 14 CIEs, Pini and colleagues report. They also note that two patients experienced both stroke and TIA during the follow-up period. And, as per a Kaplan-Meier analysis, the four-year CIE rate was 6%, with an annual CIE rate of 1.5%.

Disclosing further detail on their midterm results, the authors relay that 58 patients (19%) had a stenosis progression that was associated with a higher four-year estimated CIE rate compared to patients with stable plaque (10.3% vs. 3.2%, p=0.01). Similarly, contralateral carotid stenosis >60%

was associated with a higher fouryear estimated CIE rate (11.7% vs.

2.9%, p=0.002). A multivariate cox analysis revealed that these factors were independently associated with a high CIE risk, with hazard ratios of 3.2 and 3.6, respectively.

“The midterm results of this prospective study suggest that the incidence of CIE in [asymptomatic carotid stenosis] patients should not be underestimated, with plaque progression and contralateral stenosis serving as primary predictors of CIEs,” Pini and colleagues conclude.

Issue 101 | February 2024

Launch Pad 23

VASCULAR ACCESS

Twelve-month first-in-human data from Xeltis’ aXess haemodialysis vascular conduit trial presented at VEITHsymposium 2023

Frans Moll

Xeltis has announced “highly encouraging” 12-month results from its first-in-human (FIH) aXess vascular conduit trial.

The data were presented by Frans Moll (University Medical Center Utrecht, Utrecht, The Netherlands) at this year’s VEITHsymposium (14–18 November, New York, USA).

AT 12 MONTHS, 100% secondary patency, 78% primary assisted patency and 0% infections were observed in data from 20 patients implanted with the aXess conduit.

According to Xeltis, these results represent a significant improvement over current standard of care. This performance builds on the six-month data presented in April 2023 at the Vascular Access Society Congress in Porto, Portugal. To date, more than 3,500 dialysis sessions have been conducted across the six centres in Belgium, Italy, Latvia and Lithuania.

AXess is a restorative conduit which enables the creation of a new, longterm living vessel for haemodialysis vascular access. The aXess FIH trial is a single-arm feasibility study in Europe evaluating the preliminary safety and performance of the aXess graft in patients older than 18 years with end-stage renal disease and deemed unsuitable for fistula creation. Followup visits were conducted at regular intervals after the initial procedure, with study follow-up visits to be conducted for five years. A separate pivotal trial of aXess is underway, enrolling up to 110

Launch Pad

Overcoming barriers to gender parity through mentorship Vascular News is pleased to announce Sarah Sillito (Newcastle, UK) as our new Launch Pad columnist. She replaces Claire Dawkins, who helped launch the column—dedicated to issues important to vascular trainees—back in April 2022. Dawkins was recently promoted to the role of consultant vascular surgeon.

Here, Sillito writes about the importance of role models in reaching gender parity within surgery, highlighting in this regard the benefits of an informal regional network of female trainees that has been set up in the North East of England.

Hello everyone, I’m Sarah and I am currently a year-one core surgical trainee in the North East of England, education rep for the Rouleaux Club, but also mum to two small children.

It’s a privilege to take over this column from Claire and I wish her all the best in her role as a new consultant.

It is easy to be influenced by those around you. In my

patients across up to 25 sites in nine EU countries, with over 40 patients already implanted.

The full data were presented by Moll in a presentation entitled ‘Novel application of polymer technology to create endogenous tissue with host collagen and endothelium compatible with flowing blood: One-year clinical results of the aXess graft’.

Moll, a member of Xeltis’ medical

advisory board, said in a press release: “The 12-month data from the aXess FIH trial are highly encouraging, and continue to demonstrate the potential of the aXess vascular conduit to combine the early benefits of AVG [arteriovenous graft], such as early cannulation and no maturation needed, with the long-term advantages of AVF [arteriovenous fistula], including better patency rates, a reduced need for intervention and low infection rates.”

Eliane Schutte, CEO of Xeltis commented: “The outstanding 12-month data from our FIH study highlight aXess’ potential to transform the field of vascular access as a whole by stopping the cycle of interventions and infections. These latest results, alongside the excellent progress in enrolment for our pivotal trial, brings us closer to bringing our breakthrough solution to haemodialysis patients worldwide.”

The 12-month data from the aXess FIH trial are highly encouraging, and continue to demonstrate the potential of the aXess vascular conduit to combine the early benefits of AVG with the long-term advantages of AVF.”

first year of medical school, a male professor of surgery told me that I wouldn’t be able to be a good surgeon and a mother. I believed him and, with his words echoing in my mind, I was deterred from pursuing a surgical career for many years. However, I couldn’t ignore the fact that surgery was what I loved the most and hence I now find myself on the surgical career ladder. As a woman and a mother who is at the start of her surgical training, it was important to me to identify and surround myself with strong role models.

This is where the role of FiNEST (Females in North East Surgical Training) comes in. This is a regional network of female surgical trainees that was set up by a local vascular trainee. It’s an ever-growing group, currently sitting at around 90 members. We exist mainly through WhatsApp but have regular meetups and talks delivered by local female consultants.

Why does all this matter? Gender parity is a long way from being achieved in surgery. Females make up the substantial minority of trainees and unfortunately there are a number of deterrents and obstacles in the way of career selection and progression. The harrowing results of the recent sexual misconduct in surgery report are an obvious example but gender bias, discrimination and underrepresentation all contribute too.1 The systemic cultural changes that are required will take years to produce tangible results. This is where I believe groups such as FiNEST have a role. FiNEST has increased visibility of female surgical Sarah Sillito

trainees within the region and means that we can share our journeys, celebrate successes, and support and advocate for each other to overcome commonly encountered barriers. The benefits of mentorship are well known and play a pivotal role in career development and progression.

Whilst FiNEST is not an ‘official’ mentorship scheme, it has provided a ready-made group of role models that are visible to the new generation of female surgeons at the start of their careers and an accessible source of support. I think informal groups like these will have pivotal roles in encouraging and maintaining the female surgical workforce, especially if parity is going to be achieved. In the words of the civil rights activist Marian Wright Edelman, ‘you can’t be what you can’t see’.

SARAH SILLITO is a year-one core surgical trainee in the North East of England and education rep for the Rouleaux Club.

References 1. B ellini MI, Graham Y, Hayes C, et al. A woman’s place is in theatre: women’s perceptions and experiences of working in surgery from the Association of Surgeons of Great Britain and Ireland women in surgery working group. BMJ Open. 2019 Jan 7;9(1):e024349

As a woman and a mother who is at the start of her surgical training, it was important to me to identify and surround myself with strong role models.”

February 2024 | Issue 101

24 Point of View

VENOUS

One-year CLOUT data demonstrate low rate of PTS following treatment with ClotTriever DAVID DEXTER (SENTARA Vascular Specialists, Norfolk, USA) shared one-year data from the CLOUT registry at The VEINS 2023 (28–30 October, Las Vegas, USA).

Long-term, prospective outcome data after mechanical thrombectomy for deep vein thrombosis (DVT) are lacking, according to an Inari Medical press release. The CLOUT (ClotTriever Outcomes) registry is a prospective, multicentre study evaluating patient outcomes for proximal lower extremity DVT treated with the ClotTriever system (Inari Medical). CLOUT is the largest mechanical thrombectomy

study in the field of DVT, said Dexter, and although positive results have been previously published, this is the first report of one-year outcomes for all available patients. Patients in CLOUT were aged ≥18 years and enrolled regardless of bilateral disease, duration of symptoms, prior treatment failure for the current DVT event, or contraindications to thrombolytic therapy. A total of 310 patients completed the one-year follow-up visit.

One year after mechanical thrombectomy, moderate-to-severe post-thrombotic syndrome (PTS; Villalta score ≥10) was observed in

8.8% of treated limbs. The overall PTS rate (Villalta score ≥5) was 19.3%.

Venous patency, as measured by the presence of flow with normal or partial compressibility on duplex ultrasound, was observed in 94.2% of cases.

Additionally, significant improvements from baseline in revised Venous Clinical Severity score, Numeric Pain Rating Scale score, and EQ-5D questionnaire score were demonstrated.

In the real-world, all-comer CLOUT registry one-year outcomes demonstrate a low rate of PTS following treatment with the ClotTriever system, which was complemented by patient-centric improvements in symptom relief and quality of life. Study follow-up through two years is ongoing.

Dexter stated that these favourable clinical outcomes highlight the need

The IMAC Board Point of View The Intervention Master Aortic Course (IMAC) Board provides an overview of the most recent iteration of its annual event, which in 2023 took place in Cairo, Egypt. The event featured a Charing Cross (CX) session introduced by the late Roger Greenhalgh.

I

for randomised controlled trial data comparing mechanical thrombectomy with standard of care anticoagulation treatment. The recently initiated randomised controlled DEFIANCE trial will compare the ClotTriever system to anticoagulation for the treatment of symptomatic iliofemoral DVT.

ClotTriever device

Insights from the Intervention Master Aortic Course 2023

MAC, being the regional landmark gathering in the field of aortic interventions in the Middle East and Africa, is primarily entrusted with being the platform through which young vascular surgeons would safely and securely incorporate aortic endovascular interventions into their everyday practice. This event represents more than education; it’s a chance to foster growth, embrace innovation, learn from renowned professionals, and build meaningful connections with peers from around the world.

IMAC 2023 provided vascular surgeons with a unique and exciting format to learn the most current information about what is new and important in the treatment of vascular disease. The three-day event featured presentations, live cases and workshops from nationally and world-renowned vascular specialists.

IMAC, which in 2023 was held 18–20 October at the Intercontinental CityStars Hotel in Cairo, has grown in size, scope and international flavour over the years. It now attracts around 600 attendees, has around 177 faculty members—including 48 international faculty members—and its programme includes upward of 170 talks across more than 21 exciting and

David Dexter presents new CLOUT data at The VEINS 2023

provocative sessions, plus 20 workshops. IMAC 2023 was jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME) with 32.5 CME hours.

The importance and success of IMAC has been based on several factors, which include the people who join to put it all together, in addition to our devoted and talented core staff who have brought us to this level. Moreover, the IMAC Board is open with and target young vascular surgeons. We are dedicated to having prestigious international partners (who really are essential partners), who come from far and wide to devote their time and effort and make our meeting what it is. In this way, IMAC 2023 included sessions for many cutting-edge international conferences, with the CX Symposium, Paris Vascular Insights, Critical Limb Ischemia Course, Leading Innovative Vascular Education Aortic Surgery Peripheral & Venous “How to do it”, and SITE within the programme. Such meetings are essential to optimal care of patients because of the advances in knowledge and technologies in the vascular arena, and the international basis of these advances. This philosophy puts IMAC as an essential stamp in the calendar each

year for Egyptian, Arabic and Middle Eastern vascular surgeons as well as for our European guests.

Unfortunately, Roger Greenhalgh, the surgeon internationally renowned for his unparalleled contribution to vascular education, training and research, died peacefully on 6 October 2023, two weeks before IMAC. He was always a leader in the field and that is why he filmed the introduction video of the CX session at IMAC 2023 entitled ‘Ascending aorta and aortic arch intervention: Consensus update and unmet needs’. This session was a landmark of our programme and weighed in on prioritising early diagnosis, addressing downstream complications, identifying areas of concern, and the future of treatment in ascending and arch disease.

The second day of IMAC 2023 featured the launch of Egyptian vascular surgery guidelines in the presence of the Egyptian Health Medical Council. These guidelines aim to present all the relevant evidence on vascular surgery in order to help physicians to weigh the benefits and risks of diagnosis or therapeutic procedure in vascular diseases. They should be helpful in everyday clinical decisionmaking. IMAC had the great honour of thanking the writing and reviewing committee for their time and effort.

We are so excited to announce for the first time a new vascular surgery foundation society entitled the Egyptian Vascular and Endovascular Society (EVES).

EVES seeks to advance excellence and innovation in vascular health through education, advocacy, research and public awareness. EVES’ vision is to set standards in preventing and managing vascular disease, leading training organisations with standardised and recognised education pathways, and leading scientific organisations in vascular care.

On behalf of everyone involved in IMAC 2023, we would like to sincerely thank all attendees and speakers for their continued interest and support, hoping they had an enlightening experience over our event, and a very enjoyable stay in the beautiful, bold city that we’ve always been proud to call the land of Pharaohs.

The IMAC will collaborate with well-known bodies in Egypt to conduct the EVES Summit 2024.

Khaled Shawki, Ahmed Gamal, Mohamed Hosni Eldessoki, Sherif Omar Elkerdawi, Sherif Essam and Ahmed Eleshra (pictured above left to right) make up the IMAC Board.

Issue 101 | February 2024

Market Watch 25

Product News Paradise system

Recor Medical gains first US FDA renal denervation approval

Recor Medical has become the first company in the USA to have a device-based therapy approved for the treatment of hypertension, after it was announced that the US Food and Drug Administration (FDA) has approved the company’s Paradise ultrasound renal denervation system.

The Paradise system is intended as an adjunctive treatment option when lifestyle changes and medications have not adequately controlled a patient’s blood pressure. The Paradise catheter features the HydroCooling system, which circulates sterile water through the balloon catheter during the procedure to help protect the renal artery wall.

Approval of the Paradise system follows Recor’s positive FDA Advisory Committee Panel in August 2023. Earlier in 2023, results from Recor’s US pivotal study, the RADIANCE II randomised clinical trial, were published in the Journal of the American Medical Association (JAMA). In the study, the Paradise system met both the primary safety and effectiveness endpoints without any major adverse events.

“Despite the longstanding availability of dozens of affordable anti-hypertensive medications, blood pressure control rates in the USA are alarmingly low and falling. Given the significant blood pressure reductions seen in the ultrasound renal denervation trials, the Paradise ultrasound renal denervation system offers a much-needed advancement in our currently available options to control hypertension,” said site principal investigator Naomi Fisher (Brigham and Women’s Hospital, Boston, USA).

“Ultrasound renal denervation has proven efficacy in patients with truly resistant hypertension, a population for whom medication therapy often fails.

It is also effective in patients with mild to moderate hypertension who cannot tolerate enough medication to control their blood pressure.”

The Paradise system previously received CE mark and has been successfully introduced in Europe and is an investigational device in Japan.

“Recor is leading the way in bringing an innovative solution to clinicians and their patients struggling to control blood pressure. This FDA approval is

Clinical News the culmination of years of technical research and rigorous clinical studies,” said Lara Barghout, president and CEO of Recor Medical. “We are grateful to the patients who participated in the studies and to the clinical trial investigator teams whose diligence and dedication made FDA approval possible. We look forward to making this technology available to physicians and their patients nationwide.”

“Approval of the Paradise ultrasound renal denervation system marks an important milestone for the company and provides a new adjunctive treatment option for hypertension which remains inadequately controlled despite conventional therapies,” said Noriko Tojo, president and representative director of Otsuka Medical Devices and executive director of Otsuka Holdings Co, Ltd, the parent company of Recor Medical. “We are excited for patients and their healthcare professionals to have access to this technology to assist in managing hypertension and improving outcomes.”

Medtronic’s Symplicity Spyral renal denervation system granted US FDA approval

Medtronic has announced approval from the US Food and Drug Administration (FDA) for the Symplicity Spyral renal denervation (RDN) system for the treatment of hypertension. The company has said that it will immediately begin commercialisation.

“Medtronic has always believed in the potential of this therapy. We partnered closely with leading experts in our clinical community who could help us in our journey to get this technology to the people who need it most,” said Jason Weidman, senior vice president and president of the Coronary and Renal Denervation business within the Cardiovascular Portfolio at Medtronic. ‘It was the promise of this therapy that enabled Medtronic to keep going, even when others exited the renal denervation space. High blood pressure is a global health issue, and patients need more options to manage their blood pressure. The approval of the Symplicity blood pressure procedure represents a significant milestone for physicians and patients in the treatment of hypertension.”

The Medtronic Symplicity blood pressure procedure delivers radiofrequency energy to nerves near the kidneys that can become overactive and contribute to high blood pressure.

Symplicity Spyral

First patient enrolled in STORMPE RCT evaluating Penumbra’s Lightning Flash for treatment of acute pulmonary embolism Flowtriever

Inari Medical announces first patient enrolment in PEERLESS II randomised controlled trial

Inari Medical has announced the first patient enrolment in PEERLESS II. This prospective, global, multicentre randomised controlled trial (RCT) compares the outcomes of intermediaterisk acute pulmonary embolism (PE) patients treated with the FlowTriever system against those treated with traditional anticoagulation therapy alone.

The first patient was enrolled by William H Matthai Jr (Penn Presbyterian Medical Center at the University of Pennsylvania, Philadelphia, USA), a press release details.

“PEERLESS II is challenging the most commonly administered first-line therapy for PE around the world,” said Matthai. “Despite advances in mechanical thrombectomy, anticoagulation alone remains the standard of care. This trial aims to generate definitive evidence to influence PE treatment guidelines worldwide.”

According to Inari Medical, PEERLESS II is the largest study of its kind and will include up to 1,200 randomised patients at up to 100 global centres. The study is running alongside the currently enrolling PEERLESS RCT, which is comparing FlowTriever to catheter-directed thrombolysis. Both trials aim to generate the high-quality clinical evidence needed to move the field forward and establish FlowTriever as the optimal therapy for intermediaterisk PE patients.

“PE is a leading cause of cardiovascular death and this first patient enrolment represents an important milestone in the evolution of care for this disease,” added global principal investigator Jay Giri (Hospital of the University of Pennsylvania, Philadelphia, USA).

“The rigorous trial design, including meaningful patient-centric endpoints and independent adjudication of all safety events, lays the groundwork for this landmark study to impact future PE treatment decisions. Thank you to the PEERLESS II steering committee and clinical staff for helping us get the first patient enrolled.”

“Inari is actively enrolling three RCTs: PEERLESS, PEERLESS II and DEFIANCE, demonstrating our relentless commitment to guidelinechanging research aimed at ultimately improving patient outcomes,” said Thomas Tu, Inari’s chief medical officer.

“With the commitment of our dedicated investigators, we look forward to expedited enrolment to get us closer to changing the standard of care.”

Penumbra recently announced that the first patient has been enrolled in STORM-PE, a prospective, multicentre, randomised controlled trial (RCT) evaluating anticoagulation alone versus anticoagulation plus Lightning Flash for the treatment of pulmonary embolism (PE).

In partnership with the PERT Consortium, a multidisciplinary group dedicated to improving the care of patients with PE, the STORM-PE trial aims to advance the understanding of the role of computer-assisted vacuum thrombectomy (CAVT) in the management of acute PE, with a goal of improving the outcomes for patients with this condition.

“STORM-PE is the first head-tohead trial comparing anticoagulation, the mainstay and standard of care for treating acute PE, to CAVT,” said Rachel Rosovsky (Massachusetts General Hospital, Boston, USA), co-global principal investigator of STORM-PE. “We have already seen the significant impact Lightning Flash can have on patients. The results generated from this pivotal RCT study will provide level one evidence of how CAVT compares to current treatment paradigms and will inform us if treatment guidelines need to include this technology as a frontline therapeutic option in patients with intermediate high-risk PE,” she added.

STORM-PE will enrol up to 100 participants at up to 20 sites.

Penumbra’s Lightning Flash can be used to remove emboli and thrombi from vessels of the peripheral arterial and venous systems and can be used for the treatment of PE. A press release details that Lightning Flash combines hypotube-based Indigo Aspiration Catheters with Lightning Intelligent Aspiration, a computer-assisted clot detection technology that can differentiate between clot and blood, designed to reduce blood loss and the need for clot-dissolving drugs, which may lower the risk of bleeding complications.

“Enrolling the first patient in STORM-PE RCT is an important milestone,” said Nicolas J Mouawad (McLaren Health Care, Bay City, USA).

He continued: “This landmark RCT will be instrumental to advancing the standard of care for patients with [PE].”

Lightning Flash

February 2024 | Issue 101

26 Market Watch

Industry News

LimFlow system

Inari Medical completes LimFlow acquisition for CLTI treatment

Inari Medical has announced that it has completed its acquisition of chronic limb-threatening ischaemia (CLTI) treatment maker LimFlow.

The Irvine, California–based company earlier this month announced plans to acquire LimFlow for up to US$415 million. The deal came just weeks after Paris-based LimFlow won US Food and Drug Administration (FDA) premarket approval for its breakthrough CLTI treatment. Inari Medical intends to pay a total upfront consideration of US$250 million in cash at closing.

Contingent consideration of up to US$165 million in additional cash payments hinges on certain commercial and reimbursement milestones. Inari expects to pay those tranches out between 2025 and 2027. The company said it funded the acquisition at close

from existing cash resources.

LimFlow designed its system for transcatheter arterialisation of deep veins. It diverts blood from a diseased tibial artery to a tibial vein to deliver oxygen to a patient’s ischaemic foot.

In the initial announcement, Inari CEO Drew Hykes said the LimFlow acquisition aligns with the company’s mission to address significant unmet patient needs and adds another highly differentiated growth platform into Inari’s portfolio.

“The close of the LimFlow acquisition allows us to begin to integrate this exciting technology that is offering new hope to patients suffering from CLTI,” Hykes said in a recent news release. “LimFlow addresses one of the most significant unmet needs in all of vascular medicine, is closely aligned with our mission and adds another highly differentiated growth platform into our portfolio.”

Scott Drake appointed as Cordis CEO

Cordis has announced that its board of directors has appointed Scott Drake as chief executive officer (CEO) effective immediately. Drake most recently held the position of executive chairman of

the Cordis board of directors. He will succeed Shar Matin, who has stepped down as CEO. “Scott Drake has been on the Cordis board of directors since we acquired Cordis in 2021,” said Hunter Philbrick, H&F partner and Cordis board member.

“He has a long history building worldclass medical device organisations, bringing to market groundbreaking patient saving innovations and driving commercial excellence—along with the reputation of attracting, retaining, and developing world-class talent. Scott believes in Cordis’ ability to transform the medical industry, and with him as CEO, Cordis will achieve its vision of pioneering breakthrough cardiovascular technologies.”

Drake has over 30 years of medical device experience including as the president and CEO of the Spectranetics Corporation, where he increased shareholder value from approximately US$170 million to US$2.2 billion during his six-year tenure.

“I want to thank Shar for all he has done to stand Cordis up as an independent company. I have been on the Cordis board of directors for over two years, and I am thrilled

to be taking on a more active role as CEO,” states Drake. “We are entering the next phase of the business, where Cordis is launching new products and driving a revolutionary business model with Cordis-X that will benefit our team, customers, patients, and shareholders.”

Scott Drake

Evident Vascular, a medical technology startup developing an intravascular ultrasound (IVUS) platform leveraging artificial intelligence to enable superior imaging and streamlined workflows, recently announced that it has launched with a US$35 million Series A financing from Vensana Capital.

“The impetus to launch Evident Vascular was born out of the Vensana team’s extensive experience in the vascular space. Our team has partnered with entrepreneurs across multiple emerging therapeutic categories in vascular disease over the last two decades, including endovascular aortic aneurysm grafts, drug-coated balloons, venous stents, arterial tacks, and thrombectomy devices,” said Justin Klein, managing partner at Vensana Capital. “IVUS is ripe for innovation.

Evident Vascular is addressing a critical need in the IVUS market.”

23–24 May Pacific Northwest Endovascular Conference (PNEC) Seattle, USA

27–28 June British Society of Endovascular Therapy (BSET) annual meeting South Gloucestershire, UK

Evident Vascular exits stealth with US$35 million Series A funding to develop intravascular imaging platform

Conference calendar 3–5 March 27th European Vascular Course (EVC) Maastricht, The Netherlands

11–13 April IM Endo Forum Florence, Italy

3–6 March VENOUS2024 (American Venous Forum annual meeting) Tampa, USA

23–25 April Charing Cross (CX) Symposium London, UK

7–8 March CLI-C GLOBAL Padua, Italy

28 April 5th Annual Endovascular Interventions Symposium Palm Springs, USA

vascular-course.com

venousforum.org/education/annual-meeting

cli-courses.com/events/cli-c-global-2024

imendoforum.com

cxsymposium.com

na.eventscloud.com/website/53519/home

pnec-seattle.org

28–31 May Leipzig Interventional Course (LINC) Leipzig, Germany leipzig-interventional-course.com/visitors/ linc-2024

19–22 June Vascular Annual Meeting (VAM24) Chicago, USA

bset.co.uk/meetings/bset-annualmeeting-2024

27–29 June 24th European Venous Forum (EVF) annual meeting Athens, Greece europeanvenousforum.org

vascular.org/2024-vascular-annual-meeting

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