September 2024 / Issue 103
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EUROPEAN EDITION Featured in this issue:
4 EVAR suitability
Machine learning-based prediction model proposed
ESVS
European registry set to raise the evidence bar for deep venous intervention The pilot phase of a new European Venous Registry (EVeR)—designed to illuminate the real-world outcomes of deep venous interventions over a 10-year time horizon—is set to launch this month (September 2024).
14 Profile Kevin Mani
The importance of clinical research
track.” This longstanding need for data has recently been compounded by the requirements of the new Medical Device Regulation (MDR) in Europe, which came into effect in May 2021. Hinchliffe details that there is a need for improved data on the lifecycle of new devices, of which there have been a proliferation in recent years. “Industry doesn’t have a good, reliable and sustainable method of accessing data for new devices,” he explains, “so really this is another opportunity to be able to collect data on devices to give us an idea of, and industry an idea of, whether their devices are working and what problems may exist.” Against this backdrop, Loftus recalls that the project started with the European Research Hub (ERH), which he describes as “the research side” of the ESVS. Established in 2022, this initiative seeks to boost participation in clinical vascular research on an international scale. “I think the [ESVS] is in a very unique position because of its track record in science and because of its reputation pan-Europe but also internationally,” he says of the society’s role in seeing EVeR come to light.
Power of registry data “very significant”
DIRECTION OF TRAVEL
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eveloped and hosted by the European Society for Vascular Surgery (ESVS), the registry will be an international repository of deep venous treatment data. These will be used to collect information on the outcomes of venous interventions with the aims of driving quality and safety standards for patients upwards—and shaping future research. A lack of robust, long-term data to inform the outcomes of deep venous interventions is one of the key reasons behind the initiation of EVeR. Venous disease “is often underappreciated,” committee chair Robert Hinchliffe (University of Bristol, Bristol, UK) tells Vascular News, despite it causing significant patient harm and suffering, as well as “big financial and resource implications for health services across the world, and particularly across Europe”. Moreover, research attention in the vascular space has long been directed elsewhere, as ESVS president Ian Loftus (St George’s University Hospitals NHS Foundation Trust, London, UK) points out. “We’ve always focused very heavily on arterial disease, on aneurysmal disease,” he says, “but actually venous disease is so important, often involving a younger patient population.” On the significance of this latter point, Stephen Black (Guy’s and St Thomas’ NHS Foundation Trust and King’s College London, London, UK), who has played a lead role in setting up EVeR, remarks: “Patients need to live with the consequences of our decisions for 50 years, which means we are obliged to get answers as soon as we can to make sure we’re on the right
18 Trainee column
While randomised controlled trials (RCTs) have long been seen as the “gold standard” in terms of data collection and guiding practice, they also have their limitations, as Loftus points out. “You have very limited selection criteria,” he says, with Black adding that RCTs are “enormously expensive” and “have proved extremely difficult to recruit to,” especially in the venous space. Hinchliffe comments that a registry, on the other hand, is a good way to generate “high-quality, evidence-based data” to help specialists understand practice patterns and outcomes for various interventions and devices. “The power of registry data is very significant,” Loftus adds, referring to the successes of the UK National Vascular Registry (NVR), which he has been involved in since its inception, as a case in point. “That’s driven some really big quality improvement programmes in vascular surgery—aortic, carotid and lower limb.” He continues that a registry is particularly well suited to answer the questions that need to be addressed in the venous space. “I think we all want to know what’s really happening out there in the deep venous world,” he says. “Not just what we hear at conferences and not just what we hear from clinical trials, but what’s really happening, and within that try and refine better pathways for patient care.” On this point, Black notes that EVeR will ensure data are captured across a range of centres and not just From far left: Robert Hinchliffe, Ian Loftus and Stephen Black
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20 C arotid disease
New data on smoking cessation presented
“There’s no meeting like it”: Stage is set for CX Aortic Live 2024 A MEETING CENTRED around live case transmissions from across the world, CX Aortic Live 2024 (7–8 October, Vienna, Austria), will showcase the latest cardiac, vascular and endovascular aortic advances for a global, multidisciplinary audience. Designed to bring together all those who manage the aorta, CX Aortic Live aims to build an aortic community to focus on the best treatment techniques and technologies. Specialists from various backgrounds are invited to participate in this one-of-a-kind event, which course co-director Tilo Kölbel (Hamburg, Germany) describes as “the only meeting that has a balanced focus on open and endovascular procedures, and a balanced audience from the cardiac and vascular communities”. “It’s a global meeting,” Kölbel— who is professor of vascular surgery at the University of Hamburg and vascular surgeon at the University Heart Center Hamburg—tells Vascular News. Indeed, the programme was designed by an executive board whose members hail from across Europe and the USA and features live and edited cases from centres as far reaching as China and Japan. Kölbel is joined by Aung Oo, professor of cardiovascular surgery at St Bartholomew’s Hospital and clinical lead for aortovascular surgery at Barts Health Centre in London, UK, at the helm of this year’s meeting. The pair will guide the meeting through two days of predominantly live case transmissions, with edited cases and podium presentations also featuring. “What’s important is that half of the time and the content is live cases,” Kölbel explains, with half of the remaining programme being dedicated to edited cases. “Three quarters of the time is moving images,” he summarises, with the result being Continued on page 4