Vascular News 103 – September 2024: European Edition

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).

Developed 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

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”

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.”

DIRECTION OF TRAVEL

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

“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

Carotid disease

18 Trainee column The importance of clinical research

14 Profile Kevin Mani

Welcome to the September 2024 edition of Vascular News

Greetings dear readers, and welcome to the September 2024 edition of Vascular News

As I write this, July has just turned to August, and we have been experiencing a long-awaited taste of summer weather in London. Whether it lasts or not remains to be seen. The European Championships have come and gone—congratulations to Spain and commiserations to England and all of the other European teams who did not manage to reach the heights of European Championship glory this time around. The Olympic Games in Paris are currently in full swing and are widely regarded as a huge success as we enter the middle weekend. On the political front, France produced a somewhat untidy outcome after their recent elections with a broad left coalition; and in the UK the electorate has provided the leftward Labour party with a landslide victory, so changes are also afoot this side of the channel after 14 years of relatively ineffectual rule, for want of another word, by the centre right.

High summer is the time when most of you are either away, have been away, or are going on your annual summer vacation to wherever is you and your family’s choice of vacation venue—whether it is sunshine and the seaside, lakes and mountains or an adventure/exercise holiday. I am just back from a cycling holiday in Costa Rica, which while not entirely restful was a break from the routine.

Looking at this issue of Vascular News, we turn our attention to the Autumn/Fall congress season. From an in-house point of view, this issue includes a lead article that will introduce you to the new European Venous Registry that will be organised by the European Society for Vascular Surgery (ESVS). The article discusses the aims, timelines and how to become involved in the Registry if your centre is involved in venous disease management.

The second lead article in this edition looks at the forthcoming CX Aortic Live meeting, which will be held 7–8 October in Vienna, Austria. The programme is dedicated to the aorta and contains live and edited case transmissions as well as presentations and panel discussions. This issue includes a profile on Kevin Mani, professor of vascular surgery at Uppsala University in Sweden, who everybody involved in aortic disease management will be familiar with. Kevin will provide his insights into his career to date and thoughts for the future.

In terms of aortic topics for this issue, there are articles reporting on the one-year results of an abdominal aortic aneurysm (AAA) endoprosthesis in highly angulated necks

and the findings of the TAMBE trial—both presented at the 2024 Vascular Annual Meeting (VAM)—as well as how a machine learning-based model can aid in determining endovascular aneurysm repair (EVAR) suitability based on a recent article in the European Journal of Vascular and Endovascular Surgery (EJVES) and outcomes of a multicentre study on physician-modified endografts for complex endovascular aortic repair.

There are several interesting articles in the peripheral arterial disease (PAD) space in this issue including new data from this year’s Leipzig Interventional Course (LINC) on the BEST SFA randomised controlled trial and five-year results from the COMPARE study; the finding that the reintervention rate after endovascular treatment

There are several interesting articles in the PAD space in this issue including new data on the BEST SFA randomised controlled trial and fiveyear results from the COMPARE study”

of common femoral artery disease is associated with a relatively high reintervention rate; and an article discussing the SCOREPAD trial, which seeks to address the poor long-term survival associated with chronic limb-threatening ischaemia (CLTI) treatment.

In the carotid and venous space, there are articles on smoking cessation to improve carotid disease outcomes, a proposal for carotid endarterectomy (CEA) and transcarotid artery revascularisation (TCAR) to be “first-line” interventions for weekend carotid revascularisation and a society discussion on consensus on the management of nonthrombotic iliac vein lesions.

There is much to catch your attention in this summer issue of Vascular News. I hope that you enjoy reading it.

Sincerely yours, Rob Morgan

ROB MORGAN is professor of interventional radiology at St George’s University Hospitals NHS Foundation Trust (London, UK) and the president of the British Society of Interventional Radiology.

Editors-in-chief: Rob Morgan (European Edition) and Ross Milner (North American Edition) | Publisher: Stephen Greenhalgh

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NEWS IN BRIEF

n REMOTE TELEPROCTORING HELPS INTERVENTIONISTS OVERCOME WARTIME RESTRICTIONS IN UKRAINE:

n 3D DEVICE GUIDANCE:

Remote teleproctoring has demonstrated promising results in providing hands-on mechanical thrombectomy training and overcoming wartime migration restrictions in Ukraine, according to initial experiences published recently in the journal Interventional Neuroradiology.

For more on this story go to page 7.

A new technology is set to change the endovascular game by offering 3D, full-colour guidance to replace the 2D, greyscale standard-of-care. The result? Increased visualisation without the use of fluoroscopy. This is one of the key messages to have emerged from a roundtable discussion at the recent Charing Cross (CX) International Symposium (23–25 April, London, UK) on complex aortic procedures, Fiber Optic RealShape (FORS) technology, and the latest from Philips—FORS-powered LumiGuide.

This is an advertorial sponsored by Philips For more on this story go to page 7.

n NIVL MANAGEMENT:

n CURRENT INTRACRANIAL ANEURYSM LITERATURE REFLECTS “A FAILURE OF THE PEER-REVIEW PROCESS”: A systematic review and meta-analysis of 1,356 studies and more than 410,000 patients have found that “methodological flaws and incomplete reporting” occur frequently in studies advocating the safety, effectiveness or durability of intracranial aneurysm treatments. This forms a “potential public health hazard” for patients and, in the view of the authors, a “failure of the peerreview process”.

For more on this story go to page 13.

The diagnosis and management of non-thrombotic iliac vein lesions (NIVL) is the focus of a newly published set of consensus statements from the Vascular Interventional Advances (VIVA) Foundation, the American Venous Forum (AVF), and the American Vein and Lymphatic Society (AVLS). The report, authored by Kush Desai (Chicago, USA) and colleagues, appears as an open access article in the American Heart Association (AHA) journal Circulation: Cardiovascular Interventions For more on this story go to page 8.

n SUSTAINABILITY:

Hannah Burton (King’s Lynn, UK) and colleagues recently conducted a pilot study on the fate of device packaging for endovascular aneurysm repair (EVAR). In this issue, Burton writes about the team’s work, published as a research letter in the European Journal of Vascular and Endovascular Surgery (EJVES), and the wider issue of making endovascular practice more sustainable.

n LATEST TRIAGE-STROKE AND RACECAT DATA PUT THE BRAKES ON ALTERNATIVE STROKE TRANSFER PROTOCOLS: Recently published data from two large randomised controlled trials have indicated there may be minimal benefits, or even negative effects, associated with bypassing local or primary stroke centres and transporting patients straight to thrombectomy-capable comprehensive stroke centres (CSCs). However, investigators are in agreement that additional research is required to further elucidate the impact of transferring stroke patients directly to CSCs

For more on this story go to page 17.

For more on this story go to page 20.

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

European registry set to raise the evidence bar for deep venous intervention

Continued from page 1

those with “exceptional” or “niche” results. “By capturing data in a Europe-wide registry, we can try and get every device that’s implanted into every patient across Europe, so we will really know how these are performing, rather than judging everything by one single lighthouse centre,” he remarks.

There are downsides to registry data—Loftus points out, for example, that “you have to rely on the clinicians to be very honest with their data collection”—but there is agreement that the data collected will not stand alone, but instead form part of and indeed inform a wider evidence landscape.

Hinchliffe likens registry data to one piece of a larger puzzle. “We can’t completely replace RCTs, but we can supplement them,” he says, underlining the fact that registries illuminate outcomes in everyday clinical practice that are often obscured in RCTs.

Black is of the opinion that large-scale, real-world registry data “help to frame a number of questions that may go into RCTs”. He elaborates: “As we improve the quality of the data—a big focus of this registry is to make sure we get quality data—we hope that novel analysis techniques may allow us to draw stronger conclusions from registry data that will take us a long way forward so that the RCTs that come can be shaped properly.”

On this note, Hinchliffe adds that one of the key advantages of registry data is being able to “drive the clinical and research interests in an area”. As a result,

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he says, “the overall evidence bar and quality bar gets driven up.”

Providing an example of this, Hinchliffe states that the registry will provide an opportunity for specialists to benchmark their activity against other units, using the UK NVR as an example of this having succeeded. A registry, he stresses, should serve to both improve understanding of clinical problems but also “raise the bar” in terms of safety of procedures and activity.

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 track” — Stephen Black

Collaboration is key

Central to the success of EVeR is collaboration, with Loftus stressing the importance of getting support from the broader vascular community for it to reach its full potential. Black notes that this is not aimed at being an exclusively vascular registry. “We’re well aware that venous is treated by multiple specialties,” he says.

“It is aimed at being collaborative, and my real hope is that this becomes an exemplar of collaborative working.”

The registry will not only be collaborative across lines of discipline, but also career levels. Hinchliffe

Physician-modified endografts

“safe and effective” for thoracoabdominal and complex AAA repair

Researchers have reported a 94% technical success rate among other key findings from a recent international, multicentre, single-arm cohort study of physician-modified endografts (PMEGs) for thoracoabdominal and complex abdominal aortic aneurysm (AAA) repair. The work has been published in the American Heart Association (AHA) journal Circulation.

NIKOLAOS TSILIMPARIS (MAXIMILIAN University Hospital, Munich, Germany) and colleagues note in their introduction that, despite the widespread use of PMEGs in thoracoabdominal and complex AAAs, “robust” data on their safety and effectiveness in these pathologies are lacking. Generally, they write, previous data are “limited to small, single-centre studies”.

It was the investigators’ aim, therefore, to perform an international, multicentre study analysing the outcomes of PMEGs in elective, symptomatic and ruptured thoracoabdominal and complex AAAs.

In their research article, Tsilimparis et al detail that they defined variables and outcomes according to the Society for Vascular Surgery reporting standards and collected and analysed device modification and procedure details to inform their analysis.

outcomes including reinterventions, endoleaks, target vessel patency rates and overall and aortic-related mortality. They performed multivariable analysis with the aim of identifying predictors of technical success, 30-day mortality and major adverse event rates.

Tsilimparis and colleagues state that 1,274 patients from 19 centres were included in the study. The median age of these patients, they detail, was 74 (interquartile range, 68–79) and just over three quarters (75.7%) were men. With relation to pathologies, there were slightly more thoracoabdominal aortic aneurysms than complex AAAs included in the study—54.3% vs. 45.7%, respectively.

underlines a partnership with the junior surgeon-led European Vascular Research Collaborative (EVRC), for example, which he states has been instrumental in the development of the registry so far.

A multidisciplinary research collaborative set up by Hinchliffe and Gert de Borst (UMC Utrecht, Utrecht, The Netherlands), the EVRC encourages young vascular researchers to participate in academic projects. Hinchliffe notes that junior surgeons have played a key role in setting up EVeR due to their extensive experience dealing with multicentre studies across Europe, referencing the work of Florian Enzmann and Alexandra Gratl (both Medical University Innsbruck, Innsbruck, Austria) in particular.

With the stage for the registry now set, Black summarises his expectations for the project moving forward: “I hope that we get a better understanding of outcomes for the patients we’re treating already, a better understanding of who to treat and where we are struggling—so we know where we need to be improving—and get better treatments so that we can shape the future evolution of venous treatment.”

Black also underlines the fact that the registry will ultimately advantage all stakeholders, from surgeons and researchers to industry, regulators and— centrally—patients. “We can create something that is cost-effective for companies, answers questions for us and provides data that support regulatory applications as well as collectively improve treatment for these patients and make sure that we continue to evolve in the right direction,” he says.

Following its pilot phase, EVeR is scheduled to launch in full in September 2025. For more information and details on how to get involved, please visit https://esvs.org/ever-venous-registry/ or email Nhi Cao, European Venous Registry manager (nhi@esvs.org).

Tsilimparis et al reveal an overall technical success rate of 94%. They specify that this was the exact result for elective cases, with the figure being slightly lower (93.4%) for symptomatic patients and slightly higher (95.1%) for ruptured cases.

In addition, they share that 30-day mortality was 5.8% overall, identifying a lower rate of 4.1% in elective cases and higher rates of 7.6% and 12.7% in symptomatic and ruptured aneurysms, respectively.

Major adverse events occurred in just over a quarter (25.2%) of cases, Tsilimparis and colleagues continue, noting that they occurred in slightly fewer elective cases (23.1%) and slightly more symptomatic (27.8%) and ruptured cases (30.3%) than the average.

Finally, the authors report that freedom from reintervention was 73.8%, 61.8% and 51.4%; primary target vessel patency was 96.9%, 93.6% and 90.3%; and overall survival and freedom from aortic-related mortality was 82.4%/92.9%, 69.9%/91.6% and 55%/89.1% at one, three and five years. Median follow-up was 21 months.

Nikolaos Tsilimparis

In terms of outcomes, the authors share that efficacy was measured by technical success and safety by major adverse events and 30-day mortality. Additionally, the investigators looked at follow-up

The majority of patients presented electively (65.5%), while 24.6% had symptomatic aneurysms and 9.9%, ruptured aneurysms.

The authors relay that 83.1% of patients were submitted to a fenestrated repair, 3.6% to a branched repair and the remaining 13.4% to a combination of the two. They note that the majority of patients (85.8%) had three or more target vessels included.

Tsilimparis and colleagues summarise that PMEGs were a “safe and effective” treatment option for elective, symptomatic and ruptured complex aortic aneurysms in this international, multicentre study. “Long-term data and future prospective studies are needed for more robust and detailed analysis,” they state.

Long-term data and future prospective studies are needed for more robust and detailed analysis”

“There’s no meeting like it”: Stage is set for CX Aortic Live 2024

Continued from page 1

that the focus of the meeting is on techniques and technologies— referencing similarities with the Techniques & Technologies sessions at the annual Charing Cross (CX) Symposium—over evidence and data.

Kölbel points out that the programme is structured around live cases to such an extent that he advises attendees to stay in the auditorium for whole sessions, instead of dropping in and out, for maximum educational value. The programme does not give specific times because the timings of the edited cases and presentations must adapt to the needs of the live cases. “The focus may change when something happens in the OR [operating room],” he says.

The edited cases on the programme have been included to complement the live cases that form the foundations of the meeting. For example, Kölbel notes that three different frozen elephant trunk live cases from “world-leading” centres—Hamburg, Munich and

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Bologna—will be “augmented” by edited cases from China, Japan and Korea.

Kölbel shares that the programme will cover all four main areas of the aorta: ascending, thoracoabdominal, arch and infrarenal. On some of the programme highlights, he stresses that this is a “year of firsts” as a result of Aortic Live—now under the CX umbrella—having not taken place for the past four years, leaving “lots of updates” to cover.

“We will show a Ross procedure for

Three quarters of the time is moving images”

the first time, by a paediatric surgeon, Professor Michael Hübler from Hamburg,” Kölbel details, adding that a hybrid thoracoabdominal repair with a new graft will be another first, having never been shown as a live case before. Finally, there will be an edited case on robotic surgery, which the course codirector states has not been a part of an Aortic Live meeting until now.

Coming back to one of the cornerstones of CX Aortic Live, Kölbel stresses that “there’s no meeting like

it”. He explains that its focus on global, multidisciplinary education makes it stand out not only in its uniqueness but in the fact that this is becoming increasingly important as the cardiac and vascular communities “grow together” and there being “more overlapping case volume between the specialties compared to five or 10 years ago”.

“It becomes really important that we speak with each other, because

Machine learning-based model could aid in determining EVAR suitability

Researchers at the University Medical Center Groningen (Groningen, The Netherlands) and the University of Twente (Enschede, The Netherlands) have developed a prediction model that they claim could assist in the preoperative identification of patients who are unlikely to achieve sufficient endograft apposition after endovascular aneurysm repair (EVAR).

WILLEMINA VAN VELDHUIZEN (University Medical Center Groningen) and colleagues, including members of the Virtual Stenting study group, shared their work in a paper published online ahead of print in the European Journal of Vascular and Endovascular Surgery (EJVES). By way of background, the authors first underline an association between challenging infrarenal aortic neck characteristics, such as short apposition (less than 10mm circumferential shortest apposition length) on the first postoperative computed tomography angiography (CTA), and an increased risk of type Ia endoleak after EVAR.

It was the study team’s aim to develop a model to predict postoperative shortest apposition length in patients with an abdominal aortic aneurysm (AAA) based on the preoperative shape.

Van Veldhuizen et al note that they developed a statistical shape model to obtain principal component scores, with the dataset comprising 147 patients in total: 93 treated with standard EVAR without complications and 54 treated with EVAR who went on to experience a late type Ia endoleak.

In terms of methods, the authors detail that they obtained the infrarenal shortest apposition length from

the first postoperative CTA, which they subsequently binarised between those under 10mm in length and those equal to or longer than 10mm. The researchers then used the principal component scores that were statistically significant between the shortest apposition length groups as input for five classification models, and subsequently determined area under the receiver operating characteristics curve (AUC), accuracy, sensitivity and specificity for each classification model.

Van Veldhuizen and colleagues report in EJVES that, of the 147 patients included in the study, 24 had an infrarenal shortest apposition length of less than 10mm and 123 had a shortest apposition length of 10mm wor more.

those worlds are developing otherwise independently and, in the interest of our patients, we need to make sure that indications and standards are applied in a similar fashion in both worlds.”

For more information and to register for CX Aortic Live 2024, please visit cxaortic.com

boosting model resulted in the highest AUC of 0.77 and that, using this model, 114 (78%) patients were correctly classified, with sensitivity (less than 10mm apposition was correctly predicted) and specificity (equal to or longer than 10mm apposition was correctly predicted) at 0.7 and 0.79, respectively.

Van Veldhuizen et al summarise that the model they present can predict the binarised shortest apposition length of an endograft into the infrarenal aortic neck for treatment of an AAA on the first postoperative CTA scan, with an accuracy of 78%. Given that a shortest apposition length of less than 10mm has been associated with higher risks of type Ia endoleak, the researchers posit that their model “could help vascular specialists in the preoperative phase to accurately identify patients who are unlikely to achieve sufficient apposition after EVAR.”

In their discussion, the authors acknowledge some limitations to their study, including the fact that the information they used came from different datasets, which may have created a selection bias. “Although the EVAR group comprised consecutive patients, the dataset was enriched with nonconsecutive patients with a late type Ia endoleak from different centres,” they write.

Van Veldhuizen et al: The model can predict the binarised shortest apposition length of an endograft into the infrarenal aortic neck for treatment of an AAA on the first postoperative CTA scan with an accuracy of 78% 78%

The authors share that the gradient

Looking ahead, van Veldhuizen and colleagues suggest that their model “should be externally validated with a consecutive patient series that includes patients with an early type Ia endoleak before it can be used as a patient-specific virtual stenting tool in clinical practice.”

Willemina van Veldhuizen

AORTIC LIVE

MONDAY–TUESDAY

7–8 OCTOBER 2024

IN PERSON AND VIRTUAL

ANDAZ VIENNA AM BELVEDERE, VIENNA, AUSTRIA

REGISTER NOW

PRELIMINARY PROGRAMME ONLINE NOW

PROGRAMME HIGHLIGHTS

LIVE CASE

Valve sparing aortic root replacement (VSRR): Reimplantation

Davide Pacini, Bologna, Italy

LIVE CASE

Fenestrated aortic arch repair

Nikolaos Tsilimparis, Munich, Germany

LIVE CASE

BEVAR with outer/inner branches

Wei Guo, Beijing, China

LIVE CASE

Open repair of dissected infrarenal aortic aneurysm

Dittmar Böckler, Heidelberg, Germany

EDITED CASE

BEVAR with an inner-branch design

Mark Farber, Chapel Hill, United States

EDITED CASE

TEVAR after debranching by axillary-axillary bypass

Kazuo Shimamura, Osaka, Japan

PRESENTATION

Best practice: Risk strati cation of TAAA patients

Tara Mastracci, London, United Kingdom

One-year results confirm safety and efficacy of conformable AAA device in highly angulated necks

Results of a sub-study from the pivotal investigational device exemption (IDE) trial assessing Gore’s Excluder conformable abdominal aortic aneurysm (AAA) endoprosthesis have shown that the device is safe and effective in hostile angulated neck anatomy, with the results maintained out to one year.

MAHMOUD ALMADANI, FROM Maimonides Health in Brooklyn, USA, presented the new data at the 2024 Vascular Annual Meeting (VAM; 19–22 June, Chicago, USA).

The analysis involved 95 patients who were enrolled in the IDE trial, a prospective, multicentre clinical trial conducted at 35 US sites between January 2018 and February 2022. To be included in the high neck angulation sub-study, patients had to have an infrarenal aortic neck angulation of >60˚and ≤90˚ with an aortic neck length ≥10mm.

Gore’s Excluder conformable AAA device first gained US Food and Drug Administration (FDA) approval in late 2020, with an expanded indication for patients with aortic neck angulation ≤90° and a minimum length of 10mm

approved in May 2024.

The device is comprised of a conformable stent graft with enhanced positioning and optional angulation control. It also includes a mechanism that, after the first stage of deployment, constrains the device to 70% of its full diameter, which is intended to allow for manipulation and angulation of the proximal end of the stent graft.

“The device was designed for high neck angulation,” Almadani said during his presentation. “Many of you in the audience have experience using this device in a high neck angle situation, and I will present the data to justify its use.”

Patients enrolled in the study had a mean age of 74 years, were predominantly White and non-Hispanic, and were mostly male, Almadani

New data on TAMBE outcomes in complex aortic aneurysms revealed

The US Food and Drug Administration (FDA)-approved Gore Excluder Thoracoabdominal Branch

Endoprosthesis (TAMBE) has been shown to be safe and effective at 30 days for the treatment of patients with complex aortic aneurysms involving the visceral aorta.

THIS IS ACCORDING TO FINDINGS OF the TAMBE trial, a prospective non-randomised multicentre study investigating the use of the TAMBE device in thoracoabdominal and pararenal aortic patients, enrolled in the USA and Europe. Findings of the trial were presented at the 2024 Vascular Annual Meeting (VAM; 19–22 June, Chicago, USA) by Mark A Farber of the University of North Carolina in Chapel Hill, USA.

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 (PRAAs) of the aorta using an endovascular approach. The US FDA granted approval for TAMBE to be used in the treatment of complex aneurysmal disease in January 2024.

Farber presented the first of two arms of the TAMBE trial, which targeted type IV TAAAs and PRAAs, including 102 patients in total. A secondary

detailed, acknowledging this as one of the limitations of the study, but also that this represents the typical distribution of aortic aneurysm disease expected in this type of study.

In terms of the anatomic characteristics, Almadani noted that patients had a mean neck angle of 71˚, with a mean aortic neck length of 21mm. The most common comorbidities included hypertension, hypercholesterolemia and tobacco use.

Technical success— which was defined as a composite of successful access, deployment, removal of delivery catheters, patent and access site closure, and absence of site-reported type I or type III endoleak— was achieved in 97.9% of patients, Almadani reported, with two patients noted to have a type I endoleak at the completion of the procedure.

>5mm between one and 12 months, AAA rupture and conversion to open repair through 12 months—was recorded in 94.8% of patients for whom data were available at one year.

“The conformable IDE demonstrates the safety and effectiveness of the Gore Excluder conformable device,” Almadani said in his concluding remarks. “This was also preserved at one year, and we believe this is a new frontier for safely treating high-risk aortic neck patients with an infrarenal sealing AAA device.”

Discussion probes ideal use of device

Freedom from the primary safety endpoint—a composite of procedural blood loss >1,000mL, death, stroke, myocardial infarction, bowel ischaemia, paraplegia, respiratory failure, renal failure, and thromboembolic events— was achieved in 97.6% patients.

The primary effectiveness endpoint—a composite of technical success and freedom from a type I and III endoleak at 12 months, as well as migration of >1cm and sac enlargement

arm focused on Crawford type I-III aneurysms is continuing enrolment, having recruited 23 patients so far.

Patients enrolled in the primary arm of the trial had an average age of 73, were predominantly male (84%), and presented with significant cardiovascular risk factors including current smoking (42%) and hypertension (92%). Around 40% of patients were treated for PRAA, with around 60% treated for type IV TAAA, while 83% of the TAAA cohort and 72% of the pararenal group had an aneurysm diameter of >5.5cm.

Technical success of the procedure was achieved in all but one patient, Farber detailed, adding that there were no access failures, and 407 of the 408 target vessels were successfully stented. NonTAMBE components were required to be placed in 19 patients.

Following their procedures, patients had a mean length of hospital stay of 4.9 days, with 89.2% of patients discharged to home. No lesion-related mortality or severe bowel ischaemia were reported through 30 days.

Reinterventions were required in 9.4% of patients at 30 days, with one device-related death reported on postoperative day 39, which Farber commented was likely related to superior mesenteric artery (SMA) stent occlusion. Major adverse events occurred in 6.9% of patients, including two with respiratory failure, one disabling stroke, and two patients having developed new onset renal failure requiring dialysis. Two patients developed paraplegia.

The success of the trial was measured against two composite primary endpoints, one including

During discussion that followed Almadani’s presentation, he was asked by session co-moderator Andres Schanzer of UMass Memorial Health in Worcester, USA, about the “sweet spot” for the device, given other treatment options, including fenestrated grafts and endoanchors.

“I think this device is ideal in a situation where you have an anatomically high-risk patient, with a highly angulated neck, and you want to try to maintain an infrarenal seal zone without having to extend and manipulate the visceral vessels and place parallel stents or suprarenal stents,” Almadani responded.

technical success and procedural safety, and the second reinterventions and lesion-related mortality.

“Overall, 92% of the subjects were free from procedural safety events; however, the uncomplicated technical safety performance goal, 80%, was not met in the study because of the number of unplanned non-TAMBE devices implanted,” Farber detailed.

Patient selection is likely to have had a significant impact on outcomes, and device applicability may not reflect real-world experience, Farber said, outlining some potential limitations of the study.

“The TAMBE device has been shown to be safe and effective at 30 days at treating patients with complex aneurysms involving the visceral aorta,” said Farber. “Outcomes demonstrate a high technical success rate, no 30-day mortality, and a low rate of safety events within 30 days of the index procedure.”

However, he cautioned that the procedure is “not without risk”, citing the occurrence of paraplegia, renal failure, and a need for adjuvant stenting to resolve complications both intraoperatively and in follow-up.

“Long-term data will help determine where this treatment strategy will fit in the management of patients with TAAA and PRAA,” Farber said.

Long-term data will help determine where this treatment strategy will fit in the management of patients with TAAA and PRAA”

Mark A Farber

Mahmoud Almadani

FORS-powered LumiGuide has “gold-standard” potential for 3D device guidance without radiation

A new technology is set to change the endovascular game by offering 3D, full-colour guidance to replace the 2D, greyscale standard-of-care. The result? Increased visualisation without the use of fluoroscopy. This is one of the key messages to have emerged from a roundtable discussion at the recent Charing Cross (CX) International Symposium (23–25 April, London, UK) on complex aortic procedures, Fiber Optic RealShape (FORS) technology, and the latest from Philips—FORS-powered LumiGuide.

The CX discussion saw aortic experts Bijan Modarai (King’s College London and Guy’s and St Thomas’ NHS Foundation Trust, London, UK), Isabelle Van Herzeele (Ghent University Hospital, Ghent, Belgium) and Laurent Chiche (PitiéSalpêtrière Hospital, Paris, France) all share their experience with—and expert opinions on—Philips’ imaging offering.

Modarai began by outlining one of the central challenges of complex endovascular aortic interventions. These lengthy, multi-step procedures involve the prolonged irradiation of both the abdomen and pelvis, he explained.

“We know that this radiation is not without consequences,” Modarai said, detailing that he and his team have found evidence of DNA damage in both operators and patients as a consequence of endovascular aortic procedures.

Van Herzeele pointed out that X-ray offers only 2D visualisation of wires in a grey and white colour scheme, which make it hard to identify guidewires, catheters, and markers. The result is that operators are pressing the fluoroscopy peddle more frequently, increasing the radiation dose for both patients and healthcare staff.

Moreover, endovascular procedures are becoming increasingly common—a trend that has resulted in a parallel rise in the need for hands-on training. This is something Van Herzeele has seen in her practice at an academic institution. “Our nurses are getting worried,” she stated, adding that they are asking about

and it “shows you exactly where you are in the patient’s anatomy, without having to step on the fluoroscopy pedal”.

Van Herzeele also gave thought to what FORS has meant for workflow and for the healthcare staff at her centre. “I think the main thing is you don’t have to move your C-arm all the time, you can see what you’re actually doing,” she said. Van Herzeele added that the behaviour of the wire gives the operator some feedback that would not normally be available. “I think the team really embraces the technology from that perspective.”

Chiche shared that until recently the focus at his centre in Paris was predominantly open complex aortic surgery. In November 2020, there was a shift towards offering more endovascular procedures, facilitated by the opening of a hybrid operating room and the addition of Frédéric Cochennec to the Pitié-Salpêtrière Hospital team.

With all the potential benefits of an

require a radiation-heavy twostep procedure, first involving the deployment of a branched aortic arch stent graft and secondly either a branched EVAR (BEVAR) or a thoracic endovascular aortic repair (TEVAR). The latter was performed in this specific example.

“I think the FORS technology is a step forward in 3D navigation,” the presenter commented, who went on to report a satisfactory final result with no clinical events after the procedure.

Reflecting on what FORS has brought to his London-based practice, Modarai first identified a “wow factor”—specifically, being able to visualise a procedure in 3D. “I think that’s very powerful.”

According to Modarai, the ability to view the anatomy in a multiplanar way is another “conceptual advance,” using the example of being able to cannulate a superior mesenteric artery in the anterior/posterior position and not having to angulate the C-arm, which saves on radiation.

ways in which radiation can be reduced in line with the ALARA (As Low As Reasonably Achievable) principle.

FORS-powered LumiGuide is designed to offer a solution here: 3D device guidance using light instead of X-ray, aiming to offer better visualisation in full colour and without the need for fluoroscopy.

Van Herzeele recalled that she and her team started using FORS technology in January 2024, with Nathalie Moreels (Ghent University Hospital, Ghent, Belgium) being “the main driver” of the whole programme.

The Ghent University team’s first FORS-guided procedure was an endovascular aneurysm repair (EVAR) with an iliac branched device (IBD), using a FORS guidewire and the centre’s own catheters—an option made possible by Philips’ 3D Hub— to cannulate a contralateral limb and hypogastric artery. “That went fantastic,” Van Herzeele remembered. “We were very excited.”

Since then, the team has used FORS mainly in complex aortic pathology for fenestrated cases electively.

One of the main improvements for Van Herzeele has been full 3D visualisation of wires and catheters.

“You can visualise the guidewire very easily; it’s now in yellow, and you can also choose different colours for the catheters that you normally use,” she explained. Continuing, Van Herzeele noted that with the LumiGuide and the 3D Hub, there is the added possibility to visualise any catheter of your choice

FORS guidewire

I think the FORS technology is a step forward in 3D navigation”

Frédéric Cochennec

endovascular practice, however, came the associated radiation risks. “We tried to imagine how we could reduce the radiation dose and how we could reduce the time of exposure, for the patient, for the nurses, for the doctors, and then it appeared that the LumiGuide could help with this,” he recalled.

In November 2023, the centre adopted the LumiGuide technology, with Chiche remarking that it appears to be “a really helpful tool” so far.

“A step forward” in

3D navigation

At CX 2024, Cochennec took the audience though an edited case that demonstrated how LumiGuide can “reduce radiation and help you during the navigation phase in the aorta.”

The case involved a patient with a history of aortic root replacement who presented with a large dissecting thoracic aneurysm extending to the arch. He explained that these cases

The discussion then turned to learning curves. Chiche underscored the importance of patient selection with the FORS-powered technology and noted that the procedures are not particularly quick at first but recognised that they are still “probably safer”.

Modarai remembered being surprised by how “intuitive” the workflow was when FORS was introduced at his centre. He also highlighted the importance of patient selection. “I think as time goes by, you learn how FORS performs best, in which anatomies it performs best at this stage, and you can see how the iterations that will come will apply to much more advanced anatomies as time goes by.”

A “revolutionary” technique

Finally, the aortic experts looked to the future of FORS technology and endovascular surgery.

Van Herzeele shared her opinion that FORS is a “revolutionary” technique already and anticipated that the technology could become the “gold standard” not only for complex aortic disease, but also in other areas such as renal and visceral artery disease.

In terms of what could be improved, Van Herzeele commented that a slightly longer guidewire would be beneficial. “I think that’s something we’re sometimes struggling with, but I know that’s on the way,” she said, looking to future iterations of the technology.

In closing, Van Herzeele pointed to the wider, more global impact that FORS and FORS-powered LumiGuide might have. “I hope that the whole revolution will continue,” she said, “and that Philips will continue investing in this technology, and that together with the clinicians who are using it, we can improve the system and make it available worldwide so we can really treat every patient safely and also protect the healthcare of our staff.”

Societies seek consensus on NIVL management amid “paucity of rigorous data”

The diagnosis and management of non-thrombotic iliac vein lesions (NIVL) is the focus of a newly published set of consensus statements from the Vascular Interventional Advances (VIVA) Foundation, the American Venous Forum (AVF), and the American Vein and Lymphatic Society (AVLS).

THE REPORT, AUTHORED BY Kush Desai (Northwestern University Feinberg School of Medicine, Chicago, USA) and colleagues, appears as an open access article in the American Heart Association (AHA) journal Circulation: Cardiovascular Interventions. Imaging considerations for diagnosis, patient selection and technical considerations for stent placement, and optimal post-procedure medical therapy and surveillance are all covered in the document.

On the topic of patient selection for NIVL stent placement, the authors recommend that stenting “may be appropriate” in certain circumstances, for example in the presence of either asymmetrical oedema significantly affecting quality of life (QoL), progressive Clinical-Etiology-AnatomyPathophysiology (CEAP) class 4 to 6 venous disease, or venous claudication

with minimal superficial venous disease, or following previous treatment of underlying superficial venous reflux.

The authors warn, however, that stent placement for NIVL is “inappropriate” in patients with minimal to no symptoms and in asymptomatic patients to prevent possible future venous thromboembolism (VTE) events.

Desai et al write that stenting “may have a role” in some cases with QoLimpacting chronic pelvic pain of venous origin in the presence of parauterine veins with or without pelvic venous reflux.

The report also includes four consensus recommendations on technical considerations for stent placement, including firstly that the choice of stent size and length in NIVL “should depend on IVUS for diameter/ length measurements with compulsory fluoroscopy for length measurements”.

12 MONTH FOLLOW-UP RESULTS OF AN INDE PEN DENT RCT COMPARING VENOUS STENTING VERSUS CONVENTIONAL TREATMENT

This section of the report also addresses stent migration, which Desai and colleagues highlight can have “devastating consequences”. As a result, the authors stress that measures to mitigate the possibility of stent migration and complications— including appropriate device diameter and length—are “mandatory”.

Desai and colleagues continue that sizing based on the normal reference vessel is “generally recommended” and that stents for NIVL should be extended into the straight portion of the external iliac vein to limit complications including stent migration.

In addition, the document outlines future direction in research and education on the topic of NIVL diagnosis and management. “Evidencebased appropriateness of treatment and longitudinal management of patients with NIVL should be supported by long-term prospective trials,” Desai et al write, going on to emphasise that these should include outcomes focusing on patient QOL measures. On appropriateness, they detail that this “emphasises patient selection, intervention technique, and postprocedure optimal medical therapy and surveillance”.

Desai and colleagues underline the fact that future directions in NIVL research should include the establishment of consensus guidelines with multi-societal endorsement, and in

NIVL education, must incorporate the dissemination of future appropriateness guidelines to providers treating NIVL and to referring practitioners as the standard of care through societal endorsement.

“The challenge of developing consensus documents for the treatment and management of patients with NIVL stems from the paucity of rigorous data supporting a specific treatment strategy,” the authors write in the closing paragraphs of the document. As a result of this, they emphasise that future studies “need to focus on defining who benefits the most from the treatment of NIVL and defining the determinants of treatment success”.

Evidencebased appropriateness of treatment and longitudinal management of patients with NIVL should be supported by long-term prospective trials”

Monday, September 16 10:00 - 10:15

STEVECO Trial – The first RCT comparing venous stenting with best-medical treatment

Dr. H.Jalaie

VENOUS

Terumo Aortic announces the first commercial implant of Fenestrated TREO in Asia

On 9 April 2024, a significant milestone was achieved as Terumo Aortic introduced the first implantation of the Fenestrated TREO device in Asia. The procedure was performed at Tan Tock Seng Hospital (TTSH) in Singapore by Glenn Tan, Lawrence Quek and Pua Uei.

TTSH is the flagship tertiary hospital of the National Healthcare Group serving Central Singapore. It is one of the largest multidisciplinary hospitals in Singapore, operating 2,000 beds and has been performing complex endovascular aortic aneurysm repair for over 10 years.

Terumo Aortic shares that the next-generation Fenestrated TREO endograft has reliable staged expansion for a controlled deployment, with a trusted 19F, low-profile delivery system to treat short-neck and juxtarenal/pararenal abdominal aortic aneurysms.

Fenestrated TREO offers the physician numerous key features, the company continues, including the ability to reposition the graft while partially deployed; circumferential suture wraps; modified distal clasping to improve torque control; the ability to cannulate from above and below, enabling faster and safer access for dealing with narrow anatomies; and, notably, an optimal delivery time of less than five weeks. These features, Terumo Aortic claims, benefit physicians by providing them with the opportunity to deliver the best treatment solution to meet the needs of their patients.

The patient receiving the first Fenestrated TREO device in Asia presented with a challenging juxtarenal aortic aneurysm with a narrow visceral segment where the superior mesenteric artery and both renal arteries arise in close proximity to one another. The Fenestrated TREO device emerged as the optimal solution to accommodate the small iliac arteries and narrow visceral segment.

Reflecting on the success of the procedure, Tan, adjunct associate professor, head of the Department of General Surgery and head of Service for Vascular Surgery at TTSH, commented: “One of the reasons we selected Fenestrated TREO was for its ability to accommodate the patient’s unique anatomy. The low-profile delivery system allowed atraumatic

delivery of the endograft into the aorta and easy repositioning when partially deployed. The circumferential reduction ties further facilitated easy manipulation despite the narrow visceral segment of 16mm in this patient.”

“The reinforced fenestrations feature radiopaque tantalum coil nitinol rings and a circumferential radiopaque marker, allowing improved visualisation and alignment accuracy, facilitating quick cannulation. The locking stents in the iliac limb also reduces the risk of limb separation and endoleaks,” added Quek, adjunct associate professor and senior consultant interventional radiologist at TTSH.

“The open-top cap design of the endograft allows cannulation from above in challenging downsloping visceral vessels, without the need for preloaded catheters, which keeps the endograft in a low profile 19Fr OD delivery system, which is highly advantageous in Asian patients who often have small iliac arteries,” remarked Pua, adjunct associate professor and head of Interventional Radiology at TTSH.

One of the reasons we selected Fenestrated TREO was for its ability to accommodate the patient’s unique anatomy”

Glenn Tan

Cannulation of the fenestrations (top); Fenestrated TREO main body deployment

Clockwise from top left: Glenn Tan, Lawrence Quek and Pua Uei

Endovascular CFA treatment associated with increased rate of long-term CFA-specific reintervention, study finds

A recent study suggests that endovascular treatment of the common femoral artery (CFA) is associated with an increased rate of long-term CFA-specific reintervention, regardless of indication. Nicholas Wells, a medical student at Yale School of Medicine in New Haven, USA, presented this and other key findings from a tertiary care centre analysis of open and endovascular treatment of the CFA at the 2024 Vascular Annual Meeting (VAM; 19–22 June, Chicago, USA).

“The CFA is a common site of disease in patients with peripheral arterial disease,” Wells began. He noted that endarterectomy is seen as the gold standard of treatment, with primary patency rates “often surpassing 95% at five years” and evidence of “excellent long-term durability as far out as eight years.” The objective of the study, Wells shared, was to compare open and endovascular treatment of the CFA with a focus on reinterventions and major adverse limb events.

This was a retrospective study of all revascularisations involving the CFA, including repeated reinterventions, conducted at a single centre between 2013 and 2020. “These procedures

were performed by various specialists, including vascular surgeons, interventional radiologists and interventional cardiologists,” Wells detailed, adding that the researchers used standard comparative statistics and stratified their analysis by indication— claudication versus chronic limbthreatening ischemia (CLTI).

The researchers found that, from their database of 1,954 patients, 23% were treated for the CFA at least once and 15% of all individual revascularisations involved the CFA.

“Patients with claudication were more likely to be treated initially with endovascular therapy, at 57%, and those with CLTI were more likely to be treated with open surgery, at 60%,”

Wells added for the VAM audience.

The presenter reported that approximately one-third of the open surgery group underwent extended CFA endarterectomy involving the external iliac arteries, superficial femoral artery, and profunda femoral arteries, and about one-third underwent a concomitant ipsilateral bypass.

He also noted that approximately half of the patients in the endovascular group underwent concomitant endovascular revascularisation of the distal femoropopliteal region.

In the perioperative period, Wells shared that open surgery was associated with an increased rate of bleeding and wound infection, while endovascular therapy was associated with shorter mean length of hospital stay. Perioperative major amputation and mortality were below 1% in both groups.

“For claudication, endovascular therapy led to an increased rate of CFA-specific reintervention in the long term—35% compared to just 21% of those initially treated with open surgery,” Wells revealed.

“Additionally,” he continued, “15% of those who initially received endovascular treatment required eventual conversion to endarterectomy of the CFA, while only 5% of those who were initially treated with open surgery required a redo open CFA with endarterectomy.”

The researchers observed similar

New vessel preparation and drug delivery data spotlighted at LINC 2024

Sabine Steiner (University of Leipzig, Leipzig, Germany) took to the podium at this year’s Leipzig Interventional Course (LINC 2024; 28–31 May, Leipzig, Germany) to share, for the first time, two-year data from the BEST SFA randomised controlled trial (RCT) and final, five-year results from the COMPARE study.

BEST SFA

Steiner first revealed the latest findings from BEST SFA. By way of background to the trial, the presenter highlighted a discrepancy between the available evidence—which she noted focuses mainly on single devices and short- and intermediate-length lesions— and the “much more complex” superficial femoral artery (SFA) disease requiring the use of multiple devices that clinicians face on a day-to-day basis.

“The additive value of adjunctive therapy is unclear,” Steiner pointed out. As a result, she and colleagues sought to run an exploratory pilot study comparing strategies rather than single devices in very complex, real-world SFA lesions without restricting the use of adjunctive devices. “Actually,” the presenter highlighted, “we were encouraging the use of these devices for vessel preparation.”

In the investigator-initiated, industry-independent BEST SFA RCT, 120 patients with Rutherford category 2–4 disease were randomised in a 1:1 fashion to either a stent-preferred or a stent-avoiding treatment strategy. Steiner informed the LINC audience that both strategies had to be feasible according to the operator.

With regard to lesion characteristics, Steiner

underscored the complex nature of the SFA disease treated in the study. The mean length of the included lesions was 18–19cm and around 80% were chronic total occlusions (CTOs).

At two-year follow-up, Steiner reported a freedom from clinically driven target lesion revascularisation (CD-TLR) rate of 84% in the stent-preferred group and a 78% rate in the stent-avoiding group. There were no major amputations during this time period.

“We had a high bailout stenting rate and high rates of residual stenosis, which might explain a relatively significant loss of patency at two years,” the presenter continued. “However, the freedom from TLR rates are really promising, and we will continue to follow these patients.”

COMPARE

Later in the same session, Steiner shared final, five-year results from the COMPARE study.

“The COMPARE RCT has quite a unique study design,” the presenter began, noting that this was the first head-to-head investigation of two drugcoated balloons: one with a lower dose

outcomes in the CLTI group, where 33% of initial endovascular recipients required eventual CFA reintervention compared to 21% of those initially treated with open surgery. Conversion to endarterectomy was not found to be significant in this subgroup.

“The take-home message here was that endovascular therapy led to higher rates of CFA reintervention in the long term and that for claudicants, conversion to endarterectomy was more common following endovascular therapy than redo endarterectomy,” the presenter told VAM attendees.

After a median follow-up time of three to four years, major amputation, major adverse limb events and mortality were not found to be different. Furthermore, major adverse limb events-free survival—which was defined as time to either reintervention to any artery, major amputation or death—was not found to be significantly different between treatment approaches in either subgroup.

Senior author Cassius Iyad Ochoa Chaar, associate professor at Yale School of Medicine, told Vascular News that the anatomy of the CFA is “very peculiar,” and that the extent of the disease treated was not accounted for in this analysis. “Our future work will focus on studying the anatomy of the atherosclerosis affecting the CFA to better understand which lesions are best treated with which strategy of revascularisation,” he commented.

of paclitaxel (Ranger; Boston Scientific) and another with a higher dose (IN.PACT Admiral; Medtronic).

The study had a non-inferiority design, enrolling 414 patients with femoropopliteal lesions who were stratified for lesion length—up to 10cm, 10–20cm and 20–30cm, with a third of the patient population in each group. The patients were randomised 1:1 to treatment with either the ‘low-dose’ or ‘high-dose’ DCB.

“Non-inferiority was met for both the primary efficacy and safety endpoints,” Steiner informed the LINC audience, recalling data presented at LINC 2020.

Moving on to the new, five-year results, Steiner reported: “We do not see a significant signal for a difference between these balloons and we have a freedom from TLR rate of around 67% for the lowdose group and about 75% for the high-dose group after five years of follow-up.”

Furthermore, Steiner shared that short lesions (up to 10cm) “did very well,” stabilising earlier on with respect to CD-TLR and with a freedom from TLR rate of 80–85% at five years.

The presenter outlined “a similar picture” with lesions of 10–20cm in length, pointing out a stabilisation of reintervention after two years and a freedom from TLR rate of around 66–75% at five years.

Sabine Steiner

With regard to long lesions, Steiner underlined the fact that there were more reinterventions in this group, adding that more than half of these lesions were free from CD-TLR at the five-year time point. Finally, closing her presentation, Steiner shared that no signal for increased mortality or amputations were seen in either group.

www.ivascular.global

Claudication: Long-term Medicare

study highlights “critical” need for value-based care

A newly published US Medicare cohort study illuminates trends and factors associated with peripheral vascular interventions (PVIs)—including a sharp rise in the use of ambulatory surgical centres (ASCs) and office-based laboratories (OBLs) for treatment—from 2011 to 2022.

In the Journal of the American Heart Association (JAHA), first author Chen Dun, senior author Caitlin Hicks (both Johns Hopkins University School of Medicine, Baltimore, USA) and colleagues write that while previous cross-sectional studies have identified wide practice pattern variations in the use of PVI for the treatment of claudication, there is a paucity of data on longitudinal practice patterns. Against this backdrop, the investigators set out to describe the temporal trends and charges associated with PVI use for claudication over the past 12 years in the USA.

Dun et al conducted a retrospective analysis using 100% Medicare feefor-service claims data to identify all patients who underwent a PVI for claudication between January 2011 and December 2022. The researchers evaluated trends in utilisation and Medicare-allowed charges of PVI

according to anatomic level, procedure type, and intervention settings using generalised linear models. They used multinomial logistic regressions to evaluate factors associated with different levels and types of PVI.

Overall, Dun and colleagues identified 599,197 PVIs performed for claudication. They report in JAHA that the proportional use of tibial PVI increased 1% per year and atherectomy increased by 1.6% per year over the study period.

Furthermore, they highlight that the proportion of PVIs performed in ASCs and OBLs grew at 4% per year from 12.4% in 2011 to 55.7% in 2022, and that total Medicare-allowed charges increased by US$11,980,035 per year.

Finally, the authors share that multinomial logistic regression identified “significant” associations between race and ethnicity and treatment setting with use of both

atherectomy and tibial PVI.

In the conclusion of their findings, Dun et al summarise that the use of tibial PVI and atherectomy for the treatment of claudication has increased “dramatically” in the past decade “despite poor evidence supporting their efficacy, especially long term”. They stress that this trend is most notable in ASC and OBL settings and among non-white patients and has been associated with a “significant”

based on Medicare beneficiaries primarily aged 65 years and older who “might not be representative of the overall US population with claudication”. In addition, they recognise the downsides of administrative data, underscoring a possibility that patients they identified as having claudication had more advanced peripheral arterial disease and were misclassified. They also highlight the possibility that some of the

12.4% 55.7% 4%

The proportion of peripheral vascular interventions performed in ASCs and OBLs grew at 4% per year from 12.4% in 2011 to 55.7% in 2022

increase in healthcare expenditures over time.

Dun and colleagues note that—to the best of their knowledge—this study is the most up-to-date analysis describing the use of PVI for claudication using longitudinal, nationally representative data. The authors also acknowledge “several” limitations to their research, including the fact that their results are

SCOREPAD seeks to address “alarmingly

high”

mortality in CLTI patients with underlying coronary disease

A new research letter underscores the need to improve long-term survival following lower extremity revascularisation for chronic limb-threatening ischaemia (CLTI), setting out a randomised controlled trial to examine the impact of coronary artery ischaemia testing in these patients.

THE LETTER, AUTHORED BY DAINIS Krievins (Pauls Stradins Clinical University Hospital, Riga, Latvia), Andrejs Erglis (University of Latvia, Riga, Latvia) and HeartFlow’s senior advisor for medical affairs, Christopher K Zarins, was recently published online ahead of print in the European Journal of Vascular and Endovascular Surgery (EJVES). The authors detail that patients undergoing lower extremity revascularisation for CLTI or claudication have “poor” long-term survival due to co-existing coronary artery disease (CAD), which they note is “often asymptomatic, undiagnosed and undertreated”.

Diving into the available data on the topic, Krievins et al highlight an “alarmingly high” mortality rate in these patients that they say is evident throughout the literature. They state, for example, that the recent BASIL-2 and BEST-CLI randomised controlled trials reported a five-year mortality rate for patients with CLTI that exceeded 50% and was three times higher than the risk of amputation. They also note a 10–12% annual mortality rate following lower

extremity revascularisation in studies including both patients with CLTI and those with claudication— namely SWEDEPAD, SAFE-PAD and VQI Vision.

The authors point out that the mortality rate in these patients is not only high, but has remained unchanged over the past 40 years, contrasting a “marked decline” in the mortality rate among patients with symptomatic CAD in association with coronary revascularisation as a mainstay of treatment. Current annual mortality for patients with CAD is only 1–2%, the researchers point out, as per the ISCHEMIA, FAME 2 and SCOT-HEART trials.

Krievins and colleagues state that guidelines recommend no cardiac testing of patients without cardiac symptoms prior to vascular surgery procedures, despite patients with PAD with combined CAD having “invariably worse outcomes”. Against this backdrop, Krievins et al detail that they have embarked on a multicentre, randomised clinical trial to determine whether non-invasive diagnosis of silent coronary ischaemia together with ischaemia-targeted coronary revascularisation can

trends they report “are related to an ageing population with an increased prevalence of risk factors, rather than practice-specific changes alone”.

Despite these limitations, Dun et al write as a closing statement that their results highlight “a critical need to improve the delivery of equitable, evidence-based and value-based care for the treatment of claudication”.

improve the outcome of patients following lower extremity revascularisation.

The SCOREPAD (Selective coronary revascularisation in peripheral artery disease patients after lower extremity revascularisation) trial, will enrol up to 600 patients with CLTI or severe claudication and no known CAD after successful open or endovascular lower extremity revascularisation, Krievins and colleagues share in EJVES. The patients will be randomised to either coronary computed tomography angiography (CTA) plus computed tomography-derived fractional flow reserve (FFRCT; HeartFlow) with ischaemia-targeted coronary revascularisation in addition to best medical therapy (BMT) or BMT alone with no elective coronary revascularisation, which they note is the current guideline-directed standard of care.

The primary endpoint of the trial is a composite of cardiac death, myocardial infarction (MI) and urgent

Patient enrolment began in February 2024 and more than 80 patients have been randomised so far”

(unplanned) coronary revascularisation during twoyear follow-up, the authors detail. Extended followup will continue out to five years.

“Patient enrolment began in February 2024 and more than 80 patients have been randomised so far,” Krievins et al report in EJVES, who go on to say that the trial is seeking to include up to 10 additional sites in Europe and the USA.

Caitlin Hicks

www.terumo-europe.com

KEVIN MANI

“We need to continue to build the scientific evidence base for what we do,” Kevin Mani (Uppsala, Sweden) tells Vascular News, underlining what he believes to be a key priority for vascular surgery in the years ahead. Research has been central to Mani’s career so far, forming a crucial part of his surgical residency and pathway into vascular surgery and culminating in his current role as professor and chief of vascular surgery at Uppsala University Hospital and chair of the Swedish Vascular Registry (Swedvasc). Mani also shares one of his most memorable cases to date, recalling the successful treatment of a young patient with complex aortic disease—an experience that for him exemplified the value of continued technological innovation and teamwork in vascular surgery.

Why did you choose to pursue a career in medicine and later specialise in vascular surgery?

Medicine always felt like quite a natural choice for me and it’s something I have been interested in since childhood. When I eventually got into medicine and was exposed to various specialities, I found those that had the most impact on a patient’s life to be the most interesting. The acuteness of vascular surgery and the fact that it involves life and death situations drew me to the speciality.

Once I began my surgical career, I quickly realised that the area in surgery that was developing most rapidly and was the most fascinating was in fact vascular surgery. I did my training during a time where you still had to become a general surgeon and then go into vascular surgery as a subspeciality. Early on as a surgical resident I attended a course in vascular surgery and met Martin Björck, who was professor of vascular surgery at Uppsala University. He was the one who really opened the door to academic vascular surgery for me and was pivotal in those early days in terms of involving me in research and helping me to enter the speciality.

Were there other mentors in the early days of your career?

Anders Wanhainen was another fundamental influence during my residency—he was the supervisor for my PhD studies, and we’ve worked very closely together since, both clinically as well as academically. The way both Martin and Anders approach vascular surgery from a scientific perspective is something that has guided me in my practice. Later, following my residency in Uppsala, I moved to London and worked with Peter Taylor, who was a true global star of thoracic aortic disease and thoracic endovascular aortic repair (TEVAR), and Rachel Bell, who was the clinical lead at Guy’s and St Thomas’. They were two important mentors through those formative years of training and becoming a vascular surgeon. Rachel’s approach to honesty with the patients and the management of complex patients who are in life-threatening situations when you have to make hard decisions about what to do and what not to do, is something that I have always aspired to implement. I find it interesting how those mentors continue to affect one’s practice many, many years down the line. It’s an inspiration to think that now, I can potentially have the same effect on others!

It’s nice to be able to keep in contact with all

of these mentors at international meetings such as the Charing Cross (CX) Symposium. Over time, these mentors also become close friends.

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

A key development has been the expansion of endovascular surgery into new fields. In the aortic field, for example, there has been significant progress in minimally invasive treatments for the thoracoabdominal aorta and the arch, which has been life-changing for patients.

Taking it one step back, in Sweden, and in fact this was probably the case internationally, the active involvement of vascular surgeons in endovascular surgery happened during my early years of training. That completely changed what we do and how we regard vascular surgery. When I started my training, there was a lot of discussion about vascular surgery not surviving the next 10 years, but it has gone from being an open surgical speciality with dire prospects, to becoming this thriving area where there is a massive force for innovation and constant improvement.

In my clinical practice, I’m still amazed by what we can do to help patients with novel endovascular techniques. And these are still progressing, leaving patients better off after their repair or able to recover and get back to their normal life more rapidly. When it comes to the arch and the thoracoabdominal aorta this has been particularly transformative.

Patients that were regarded as “untreatable” some years ago, e.g. with aortic rupture in a challenging re-do field, can now be salvaged with innovative use of available stent-grafts with various tailored modifications.

What are the biggest challenges currently facing vascular surgery?

One of the main challenges for vascular surgery in 2024 and beyond is that we need to continue to build the scientific evidence base for what we do.

Being a speciality that has a very strong innovative side to it, we need to continue to show that what we do matters and makes a difference. This is particularly important in an environment where there is competition for money in healthcare. We need to remember that while innovation is fantastic and is of great benefit to patients, it also gets us under fire sometimes in terms of whether modern techniques are durable enough, or better than

FACT FILE

CURRENT APPOINTMENTS

Professor and chief of vascular surgery, Uppsala University Hospital (Uppsala, Sweden)

Vascular surgeon, Uppsala University Hospital

Director, Uppsala Aortic Fellowship

Chair, Swedish Vascular Registry (Swedvasc)

Associate editor, European Journal of Vascular and Endovascular Surgery (EJVES)

PAST APPOINTMENTS (SELECTED)

Clinical fellow, Vascular surgery, Guy’s and St Thomas’ NHS Foundation Trust (London, UK)

Chair, Vascunet and International Consortium of Vascular Registries

Scientific secretary, Swedish Society for Vascular Surgery

EDUCATION

PhD, Vascular surgery, Uppsala University (Uppsala, Sweden)

MD, Medicine, Lund University (Lund, Sweden)

AWARDS (SELECTED)

Swedish Surgical Society’s Great Researcher Prize

Swedish Vascular Award

the alternatives. There have been areas where we have been too quick in adapting new technology that did not show benefit or stand the test of time. We should be cognisant about the fact that we need to have evidence for what we do.

We must continue working on building that evidence base so that we can continue to incorporate innovation into our clinical practice.

As the chair of Swedvasc, could you comment on the benefits of registry data in vascular surgery?

I had the privilege of getting involved in registry research early on through my mentors. High-quality registries that capture the practice of vascular surgery in a country or a region are valuable sources of data to various types of studies. This includes epidemiological studies, which assess what we are treating, how we are treating it, and what the trends are; and outcome studies, which assess the results of different treatments that we offer to patients and the patient selection for these treatments. Nesting randomised trials into registries is another powerful tool, and registry-randomised studies are increasingly used to evaluate new devices and interventions.

Vascular surgery is a field that deals with various low-incidence diseases—not necessarily the rarest diseases in the world but rare enough to be difficult to study in randomised controlled trials. Swedvasc and international registries in Vascunet have contributed significantly to the vascular surgery evidence base, with data now available on the management of various scenarios including infected grafts and ruptured internal iliac aneurysms.

We have been able to establish evidence for new technologies (e.g. endovascular aneurysm repair [EVAR] for infected aneurysms), as well as the threshold for repair for some of the pathologies involved, in studies that would be extremely difficult to conduct in any other way because we cannot find large enough cohorts of patients. The registry serves both to evaluate practice and identify best practices, as well as offer the possibility of spreading that best practice to new units and establishing evidence for new techniques that are being introduced. There is a strong interest internationally for registries with the availability of new technologies for the management of big data. There is also an increasing number of good quality national registries established across Europe and indeed around the world. I believe

we’ve only scratched the surface when it comes to large-scale registry data for both the evaluation of practice as well as for the monitoring of new device outcomes. Clearly there is a lot of future potential.

Could you outline one of your most memorable cases?

When I was working for a year in New Zealand, we had a young patient with an aortic arch and a thoracoabdominal post dissection rupture. It was practically impossible to treat him with any traditional open surgical or endovascular technique.

However, thanks to the development of hybrid repair, the availability of modern stent grafts, and a very good team of vascular surgeons, radiologists and anaesthesiologists who would dare to go into an uncertain situation, we sealed off the rupture and saved this young father. He had initially been palliated until we found a reasonable solution for him, and he has lived for several years since the procedure. I think this is a case

that really underlines the fact that modern technology allows us to do certain procedures that were not possible some years ago, and we certainly benefitted from having an enthusiastic team who were willing to take on new technology to save a patient.

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

Medicine is a unique craft; the patient encounters and the impact we can have on peoples’ lives is what makes it truly special. This is not a one-person job—the impact is best achieved in high-performing teams where individuals support each other aiming for the best result.

I would advise anyone looking to start a career in medicine to go with your gut feeling—find the area where you want to make your impact and find the team where you will prosper and thrive to make the most impact. To me, it is important to have fun at work. Vascular surgery is not a nine to five job—disasters happen 24/7 and patients need

"I believe we’ve only scratched the surface when it comes to large-scale registry data”

help unexpectedly—so this is an area where a certain level of passion and enjoyment is required. If you find a team that you enjoy being a part of, and you have a passion for saving lives and limbs, then vascular surgery is the speciality for you. In addition, I think an interest in innovation is beneficial if you’re going into vascular surgery. It’s been a speciality where innovation has been transformative, and there are still areas of innovation such as imaging, radiation-free practice, and artificial intelligence (AI) that are continuing to push the boundaries of what we can do.

What are your hobbies and interests outside of medicine?

I live in Sweden, so obviously we have proper winters and I enjoy skiing during that season, especially downhill. My kids also have the same interest. Then in the summertime, I very much enjoy dinghy sailing in the Swedish archipelago and spending time by the water with my family.

Endothelial tight junctions and their role in vascular access Nikos Giannikas Panos Kitrou

Nikos Giannikas and Panos Kitrou (Patras, Greece) write together about the role that endothelial tight junctions play in vascular access, evidence from previous studies, and a proposed upcoming study that aims to evaluate the expression of the main tight junctions (TJ) proteins at the endothelium of end-stage kidney disease (ESKD) patients.

Stenosis is the Achilles’ heel of vascular access, leading to dysfunction and compromised haemodialysis. Owed to several factors, the histopathologic entity responsible for this is described as venous neointimal hyperplasia (VNIH).1 The latter is mainly attributed to vascular injury, inflammation and haemodynamic stress which triggers contractile smooth muscle cells and myofibroblast proliferation migrating to the area of stenosis. These cells produce extracellular matrix which, together, create an aggressive fibromasular thickening.2,3

Chaudhury et al stated that high levels of urea exacerbate the endothelial

dysfunction, possibly through pathways of inflammation and oxidative stress. Moreover, urea was held responsible for the development of neointimal hyperplasia in both chronic-kidney disease (CKD) and ESKD patients without previous vascular access placement.1,4

Vazari et al described in their article how, in an animal experimental study, pathologic urea levels—along with other retained toxins—exert a change in the microbiome of the gut, while the presence of uraemia alone provokes disruption of the intestinal epithelium, a pathological entity known as “leaky gut”.5 Their study showed the impact of uraemia in the paracellular pathway

of the epithelium. According to the authors, urea highly affects the main constituent of the paracellular pathway, the TJ, which act as the blood-gut barrier. Blood-gut barrier malfunction (even at the early stage of the CKD) allows a plethora of toxins to enter the systematic circulation and further deteriorate the kidney function. A recent single-centre, non-randomised clinical study involving 44 patients—divided into three groups—demonstrated that ESKD patients had significantly reduced intestinal levels of occludin and claudin, as confirmed by duodenal biopsies. These reductions were correlated with systemic endotoxemia when compared to the control group.6 Thus, once the intestinal barrier is disrupted in CKD, the translocation of bacteria-derived uremic toxins and other noxious luminal contents into the systemic circulation induce inflammation, vascular calcification, insulin resistance, decreased bone turnover and leukocyte stimulation.7

The blood-brain barrier has also been suggested to be affected by uraemia. This barrier is the only site that the TJ of the endothelium—and not epithelium— have been assessed. According to Hernandez et al, circulating toxins enter the brain circulation, resulting in neurological complications such as dementia, cognitive impairment, increased risk of stroke, retinopathy.8,9 TJ are complex proteinic structures located at the upper intercellular clefs of the epithelial cells and to a lesser extent, in the endothelium. They maintain the integrity of the paracellular barrier, and they also regulate the cell polarity by restricting the movement of membrane protein. They consist of three different protein teams, namely the transmembrane (occludin and claudin), the cytosolic (zonula occludens) and the

Figure 1. Study design overview: This diagram outlines the study design for evaluating the expression of main tight junction proteins at the endothelium (arteries and veins) of patients with ESKD and non-ESKD patients. The prospective, single-centre, quadruple-arm, non-randomised interdisciplinary proof-of-concept study will involve 100 patients, divided into two main groups: ESKD patients and non-ESKD patients. The ESKD group includes pre-dialysis (25) and dialysis (25) patients. The nonESKD group comprises PAD patients (25) and nephrectomy patients (N group; 25).

peri-junctional (actin and myosin).4

The aim of our study is to evaluate the expression of the main TJ proteins at the endothelium (arteries and veins) of ESKD patients. This will be a prospective, single-centre, quadruplearm, non-randomised interdisciplinary proof-of-concept study involving 100 patients. There will be 50 ESKD (Group 1) and 50 non-ESKD (Group2) patients. Subjects’ recruitment is shown in Figure 1.

The ESKD group will consist of 25 pre-dialysis patients (Pre-D-group) and 25 dialysis patients carrying a dialysis catheter (D-group). In both groups tissue samples will be collected during scheduled arteriovenous fistula creation from the site of the anastomosis. The non-ESKD group will consist of 25 peripheral arterial disease patients (PAD-group) scheduled to undergo amputation, suffering common comorbidities with ESKD patients, without kidney dysfunction. The other 25 specimens will be collected from healthy vessels (no-comorbidities, no ESKD) from patients scheduled for nephrectomy. (Nephrectomygroup). Venous sampling will take place to all patients to evaluate different biomarkers.

The aim of the non-ESKD group is to evaluate the condition of TJ in patients without uraemia and that comorbidities do not affect expression of TJ proteins. In the ESKD group the different subcohorts aim to evaluate whether dialysis maybe a triggering factors influencing TJ protein expression.

Specimens will undergo a histopathologic assessment. To quantify the proportion of the TJ within the specimens, an immunohistochemical examination will be performed.

References:

1. Lee T, Chauhan V, Krishnamoorthy M, et al Severe venous neointimal hyperplasia prior to dialysis access surgery. Nephrol Dial Transplant 2011;26(7):2264-70.

2. <2015. Chronic kidney disease alters vascular smooth muscle cell phenotype.pdf>.

3. Lee T, Roy-Chaudhury P. Advances and new frontiers in the pathophysiology of venous neointimal hyperplasia and dialysis access stenosis. Adv Chronic Kidney Dis. 2009;16(5):329-38.

4. Lee DBN, Huang E, Ward HJ. Tight junction biology and kidney dysfunction. American Journal of Physiology-Renal Physiology. 2006;290(1):F20-F34.

5. Vaziri ND, Yuan J, Norris K. Role of urea in intestinal barrier dysfunction and disruption of epithelial tight junction in chronic kidney disease. Am J Nephrol 2013;37(1):1-6.

6. Georgopoulou GA, Papasotiriou M, Bosgana P, et al. Altered Expression of Intestinal Tight Junctions in Patients with Chronic Kidney Disease: A Pathogenetic Mechanism of Intestinal Hyperpermeability. Biomedicines. 2024;12(2).

7. Vaziri ND. Gut microbial translocation in the pathogenesis of systemic inflammation in patients with end-stage renal disease. Dig Dis Sci 2014;59(9):2020-2.

8. Hernandez L, Ward LJ, Arefin S, et al. Blood-brain barrier and gut barrier dysfunction in chronic kidney disease with a focus on circulating biomarkers and tight junction proteins. Sci Rep. 2022;12(1):4414.

9. Toyoda K. Cerebral small vessel disease and chronic kidney disease. J Stroke. 2015;17(1):31-7.

Nikos Giannikas is an interventional radiology resident at the University Hospital of Patras and head of the organising committee of the Endo Vascular Access (EVA) meeting.

Panos Kitrou is an associate professor in interventional radiology at Patras University Hospital and director of the EVA meeting.

Point of View

One of the hottest topics at LINC 2024

• BeBack with 2.9 F or 4.0 F for retrograde, antegrade and crossover approach

• Needle out of the tip in adjustable length and direction

• The e ective low profile catheter for support, Crossing, and re-entry

Clinical research: A part of everyone’s future

In her new role as an academic clinical fellow in vascular surgery, our Launch Pad columnist Sarah Sillito (Newcastle, UK) writes about the importance of creating a research-confident workforce at the medical school level.

The first Wednesday in August marks the start of a new year for most doctors in the UK, whether that involves starting as a newly qualified doctor, embarking on a new training programme or progressing up the rungs of the training ladder. For me, this year, it was the start of my role as an academic clinical fellow in vascular surgery. I am excited to work with the research team and look forward to seeing what direction my research goes in.

The world of clinical academia can feel daunting at first with many very knowledgeable and experienced people analysing data and statistics, asking difficult questions and using seemingly alien terminology. I confess that it was not a direction I thought my career would go in when I

first qualified. Reflecting on my time at university, I do not think I was made aware of clinical research as a career until a talk in final year about applying for what was then called the Academic Foundation Programme and it did not appeal to me. A few years later, I found myself in the fortunate position of working in a department with research-active clinicians who encouraged me to help with their projects and I found an area of research that I enjoyed. In my limited experience of working within clinical academia it has been great to see the number of medical students keen to help with projects and the increasing number of initiatives connecting students and trainees with mentors who can facilitate access to research opportunities.

The multiple demands that have been placed on healthcare and the rapid development of technology means the way of promoting health and treating ill-health is changing. The emphasis on providing evidence-based medicine is taught from early on in medical school. It should go further though and teach how exactly research underpins these decisions and how clinicians can be involved in improving patient outcomes.

Developing competencies in clinical research should start early on in medical school so that we have a workforce that is confident in engaging in both local and national research opportunities and communicating opportunities to patients and the public.

The knock-on effect of this

CEA and TCAR should be “firstline” interventions for weekend carotid revascularisation, researchers advise

Patients who undergo carotid revascularisation at the weekend have increased odds of complications and mortality, with transfemoral carotid artery stenting (TFCAS) posing the highest risk and transcarotid artery revascularisation (TCAR) the lowest, compared to carotid endarterectomy (CEA). This is one of the key findings of new observational research published online ahead of print in the Journal of Vascular Surgery (JVS).

LEAD AUTHOR MOKHSHAN Ramachandran, senior author Mahmoud Malas (both UC San Diego, San Diego, USA) and colleagues state in their research article that outcomes for weekend surgical interventions are known to be associated with higher rates of complications and mortality compared to weekday interventions. The aim of their study was to assess the ‘weekend effect’ for the three available carotid revascularisation methods—CEA, TCAR and TFCAS—noting that research on the topic is currently only available regarding CEA.

To do this, the researchers queried the Vascular Quality Initiative (VQI) for patients undergoing CEA, TCAR and TFCAS over a six-year period, from 2016–2022. They employed Chi-square and logistic regression modelling to analyse outcomes including in-hospital stroke, death, myocardial infarction (MI), and 30-day mortality by weekend versus weekday intervention. Providing more details on their study methods, Ramachandran et al write that they used backward stepwise regression to identify significant confounding

could spread far and wide. Evidence shows that clinically active research hospitals have better patient outcomes and patients are more confident in the staff.1,2 More early awareness of clinical research could potentially lead to increased recruitment of doctors with an academic interest and having this extra component to a career could help retain workforce numbers and reduce burnout from clinical work and perhaps even increase recruitment to understaffed specialties. Most importantly, being proactive and engaging in clinical research drives innovation and change. A career in clinical research is not for everyone, but clinical research is a part of everyone’s role and future and ensures that healthcare delivery is always evolving and meeting the needs of society.

Being proactive and engaging in clinical research drives innovation and change”

References: 1. Ozdemir BA, Karthikesalingam A, Sinha S, et al. Research activity and the association with mortality. PLoS One. 2015 Feb 26;10(2):e0118253. doi: 10.1371/journal.pone.0118253. PMID: 25719608; PMCID: PMC4342017. 2. Jonker L, Fisher SJ, Dagnan D. Patients admitted to more researchactive hospitals have more confidence in staff and are better informed about their condition and medication: Results from a retrospective cross-sectional study. J Eval Clin Pract 2020; 26: 203–208. https:// doi.org/10.1111/jep.13118

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

variables, and that logistic regression of outcomes was substratified by symptomatic status. Furthermore, they used secondary multivariable analysis to compare outcomes between the three revascularisation methods by weekend versus weekday interventions.

Overall, Ramachandran and colleagues analysed 155,962 procedures in their study, comprising 103,790 CEA, 31,666 TCAR and 20,506 TFCAS. Of these, the authors specify, 1,988 CEA, 246 TCAR and 820 TFCAS received weekend interventions.

In JVS, the authors report that they observed no significant differences for TCAR, and increased odds of in-hospital stroke, death and MI for CEA and TFCAS procedures conducted at weekends.

Ramachandran et al also share the following additional findings:

• Asymptomatic TCAR patients had nearly triple the odds of 30-day mortality

• Odds of in-hospital death were nearly tripled for asymptomatic CEA and asymptomatic TFCAS patients

• CEA and TCAR had no significant differences for all outcomes

• TFCAS was associated with increased odds of stroke and death compared to CEA and TCAR

In the conclusion of their findings, Ramachandran and colleagues

summarise that weekend carotid revascularisation is associated with increased odds of complications and mortality, adding that asymptomatic weekend patients perform worse in the CEA and TFCAS groups.

“Among the three revascularisation methods, TFCAS is associated with the highest odds of perioperative stroke and mortality. As such, our findings suggest that TFCAS procedures should be avoided over the weekend, in favour of CEA or TCAR,” the authors write. They continue that, in patients who are poor candidates for CEA, TCAR offers the lowest morbidity and mortality for weekend procedures.

Sharing the take-home message from their research, Ramachandran et al posit that CEA and TCAR procedures should be the “first-line” interventions for weekend carotid revascularisation.

Our findings suggest that TFCAS procedures should be avoided over the weekend, in favour of CEA or TCAR”

Sarah Sillito

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Mahmoud Malas

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Sustainability in endovascular practice—it is time to do more

Hannah Burton

Hannah Burton (Bedford, UK) writes about a new study— recently documented in the European Journal of Vascular and Endovascular Surgery—on the fate of device packaging for endovascular aneurysm repair (EVAR).

SUSTAINABLE SURGERY IS an ever-growing topic of interest due to the global threat of climate change. Little is published about waste production in the vascular community with seemingly minimal awareness of adaptations to create an environmentally positive impact. We must promote discussions and action advancements in our specialty whilst simultaneously protecting the environment and preventing compromise for future generations from achieving their goals.1

The full vascular burden cannot be solely targeted—this would be an unrealistic challenge. I have examined disposal of EVAR device packaging within my trust to highlight current

issues. The growing demand for this type of repair and an expanding market of stent grafts inevitably results in a need for more packaging. Only once the concern is underlined can we generate future strategies.

Our review summarised that packaging for EVAR devices contained between four and seven elements. The majority of materials were classed as recyclable as per company representatives; however, no packaging displayed the universal recyclable symbol. Alongside the main-body and limb devices it is common practice to use supplementary equipment like sheaths, balloons and polymer injections, which require additional, essential packaging with three

to five components. Any recyclables handled by scrub nurses are deemed medical waste as per local regulatory policy, and therefore the majority go to incineration, unnecessarily contributing socioeconomically and environmentally. These results were astounding. The majority of packaging is recyclable yet regularly disposed of inappropriately or falls outside the local policy criteria. Additionally, there are redundant components including booklets which are an environmental burden. Remarkably this is only one segmental review of the vascular community’s workload and is likely translatable to other interventions and specialties. The introduction of minimally invasive surgery over the past 20 years has brought undeniable patient benefits yet brings more singleuse instruments, which are mistakenly viewed as more economical despite hidden expenses like disposal. Hence, we must reflect on current practices and adapt as clinical professionals synergistically with manufacturers. It appears there is lack of current regulations, absence of reprocessing of materials, deficiency of clear institutional waste sorting policies and absence of green teams. These simple strategies should be implemented nationwide initially to tackle the ever-pressing challenges. Inappropriate incineration causes harmful environmental byproducts alongside the financial burden of running such facilities so we hope to create a cultural and educational change alongside implementing real transformations.2

Smoking cessation remains a “ripe target” for improved medication adherence in carotid disease

New data presented at the 2024 Vascular Annual Meeting (VAM; 19–22 June, Chicago, USA) have revealed poor overall rates of medical therapy adherence in moderate asymptomatic carotid stenosis patients—with smoking cessation representing a “ripe target” for improvement moving forward.

“The objectives of this study were to examine adherence to three common tenets of medical therapy among a cohort of patients treated with medical therapy alone, and then to identify shortfalls in therapy to serve as opportunities for improvement,” said Randall Bloch (St Elizabeth’s Medical Center, Boston, USA), presenting these data on behalf of senior author Mark Conrad (St Elizabeth’s Medical Center, Boston, USA) and colleagues.

The single-centre, retrospective study involved reviewing consecutive carotid duplex ultrasound scans from 2019–2020. Patients with moderate (50–69%) asymptomatic carotid stenosis—based on Society for Vascular Surgery (SVS) guidelines—were included in the study, while those who underwent upfront surgery “for any reason” were excluded, as were those without available follow-up data. Patients were assessed for their adherence to optimal medical therapy at the time of the index duplex scan, the first follow-up visit, and at each subsequent follow-up visit until the end of the

study, ultimately leading to a median follow-up period of 2.7 years. In the study, optimal medical therapy was defined via three key tenets: abstinence from smoking; use of aspirin or other antiplatelets; and use of statins or other lipid-lowering therapies.

The study, now also published in the Journal of Vascular Surgery, identified a total of 323 duplex ultrasound examinations with moderate asymptomatic carotid stenosis across 255 patients. Bloch reported that 56.1% of these patients were already on all three of the aforementioned aspects of medical therapy at the time of the index duplex, with this rate improving to 68.6% by the end of the follow-up period.

“However,” Bloch continued, “when looking specifically at the 112 patients that were not already on medical therapy, 38.4% were able to achieve adherence to all three tenets of medical therapy by the end of follow-up—and abstinence from smoking was the aspect of medical therapy that was least commonly achieved.” The presenter went on to highlight the fact that patients with hypertension and those who were

In conclusion, raising awareness that the growing endovascular device market is impacting carbon footprints is imperative. We must take the initiative at higher executive levels to engage in environmentally friendly disposal practices. We should follow and surpass the Intercollegiate Green Theatre Checklist, making this a prominent National Health Service (NHS) agenda.3 Manufacturers should amend processes for example using packaging from recycled materials. Similar papers are gradually emerging on this topic and given EVAR is a well-developed technique, the recognition of this aspect has been remarkably slow. We are already broadening collaboration with interested parties to improve sustainability outcomes without compromising clinical care for vascular patients and ultimately taking steps to help the environment and our healthcare system.

References

1. Burton HLE, Chaudhuri A. Sustainability in Endovascular Practice: A Pilot Study on the Fate of Device Packaging for Endovascular Aortic Aneurysm Repair. Eur J Vasc Endovasc Surg. 2024 Jul 13:S1078-5884(24)00623-3. doi: 10.1016/j. ejvs.2024.07.019. Epub ahead of print. PMID: 39009109

2. Zikhathile T, Atagana H, Bwapwa J, et al. A Review of the Impact That Healthcare Risk Waste Treatment Technologies Have on the Environment. Int J Environ Res Public Health. 2022;19:11967.

3. Robinson P, Surendran K, Lim S, et al. The carbon footprint of surgical operations: a systematic review update. Ann R Coll Surg Eng. 2023;105: 692-708.

Hannah Burton is an ST5 vascular surgery trainee at Bedfordshire - Milton Keynes Vascular Centre, Bedfordshire Hospitals NHS Foundation Trust.

not smoking at the outset of the study demonstrated the highest rates of medical therapy adherence.

According to Bloch, non-smokers achieving generally better adherence rates was able to be attributed to a rapid, initial uptake in adherence, likely due to “the relative ease of adding additional medications to the regimen, as opposed to the relative difficulty of smoking cessation”. In addition, multivariable analysis revealed that smoking at the time of the index duplex was associated with lower odds of achieving optimal medical therapy adherence.

“In conclusion, adherence to best medical therapy is suboptimal—less than 40% of patients who were not previously on therapy were able to achieve adherence to best medical therapy by the end of follow-up,” Bloch stated. “And, so—despite rapidly evolving medical therapies for cardiovascular risk reduction—smoking cessation remains a ripe target for interventions aimed at adherence to medical therapy.”

Adherence to best medical therapy is suboptimal—less than 40% of patients who were not previously on therapy were able to achieve adherence to best medical therapy by the end of follow-up”

Point of View

CAROTID

Teichgräber U, et al. New safety and effectiveness data of Luminor DCB at 5-year: EFFPAC TRAIL. Presented in LINC 2022, Leipzigh.

Vascular Therapies completes enrolment in the ACCESS 2 study

Vascular Therapies has announced completion of enrolment in the ACCESS 2 trial, a Phase III prospective randomised, multicentre clinical study of Sirogen for the surgical creation of arteriovenous (AV) fistulas in patients requiring haemodialysis vascular access.

Vascular Therapies developed its sirolimus formulation (Sirogen) for intraoperative local, perivascular drug delivery. In a post-hoc sub-group analysis from ACCESS, the original US prospective randomised study, Sirogen showed improved fistula maturation and secondary patency when compared to standard of care controls.

The ACCESS 2 study was designed to validate the post-hoc results from ACCESS and further evaluate the effectiveness of Sirogen to improve outcomes in patients requiring an AV fistula. This multicentre randomised study enrolled 136 patients across 17 centres in the USA and the UK. The primary endpoint of the study is fistula maturation at six months, and results are currently expected to be announced in the second quarter of 2025.

John McDermott, chief executive officer of Vascular Therapies, said: “We are very pleased to complete enrolment in this important clinical study. A functional vascular access is the lifeline for dialysis patients and although AV fistula remains the preferred vascular access for most haemodialysis patients, there is still an unacceptably high rate of failure necessitating reinterventions, increasing patient morbidity and healthcare costs. We are confident that Sirogen has the potential to provide patients with kidney disease a new therapy to improve vascular access outcomes.”

Sriram Iyer, chief scientific officer of Vascular Therapies, added: “The encouraging outcomes from the original ACCESS study provide a strong signal that Sirogen has the potential to bridge an important unmet clinical need and we are optimistic that the ACCESS 2 outcomes will be confirmatory. We would like to thank the patients, physicians and research personnel and are very grateful for their cooperation and participation in this study.”

InspireMD congratulates CREST-2 investigators on completion of trial enrolment

InspireMD recently congratulated the lead investigators on the completion of enrolment in the CREST-2 clinical trials.

The CGuard embolic prevention stent system (EPS), utilising InspireMD’s MicroNet mesh, was included as a device option for stenting in the CREST-2 trials following US Food and Drug Administration (FDA) approval of the company’s

investigational device exemption (IDE) supplement application in February 2022. CREST-2 included 23 cases implanted with CGuard.

Marvin Slosman, chief executive officer of InspireMD, stated: “We would like to thank Dr [Brajesh] Lal and the other investigators who are executing this landmark trial, a remarkable achievement in the field of carotid revascularisation and stroke prevention. We are proud to have been the only second-generation investigational device option approved by the FDA for inclusion in the stenting arm of the trial, which we believe reflects the desire of the CREST-2 committee to offer the latest stenting technology. It has been our honour to contribute to this important work.”

Lal (University of Maryland School of Medicine, Baltimore, USA), who is co-principal investigator of the CREST-2 trial, stated: “There continue to be significant advancements in the field of carotid revascularisation and stroke prevention, and information from this study will help determine the optimal treatment for carotid stenosis patients without stroke symptoms. This trial, when complete, will ensure that we remain current with state-of-the-art innovation to achieve the best possible short- and long-term patient outcomes. Along with my fellow investigators, we eagerly await topline results from this important study.”

An InspireMD press release notes that CREST-2 is two independent multicentre, randomised controlled trials of carotid revascularisation and intensive medical management versus medical management alone in patients with asymptomatic high-grade carotid stenosis.

One trial randomised patients in a 1:1 ratio to carotid endarterectomy versus no endarterectomy and another randomised patients in a 1:1 ratio to carotid stenting with embolic protection versus no stenting. Medical management is uniform for all randomised treatment groups and is centrally directed.

CIRSE begins CALCIO trial enrolment for treatment of CLTI with Shockwave IVL system

The Cardiovascular and Interventional Society of Europe (CIRSE) has announced that patient enrolment for the CALCIO trial has begun. CALCIO started patient enrolment

on 15 July 2024, with the goal of recruiting 400 chronic limb-threatening ischaemia (CLTI) patients over the next two years.

CALCIO is a prospective, observational cohort study that is collecting real-world data on the use of intravascular lithotripsy (IVL) with the Shockwave Medical IVL system (Shockwave Medical) to disrupt vascular calcifications in patients with CLTI.

The study was initiated and is cochaired by Raman Uberoi (The John Radcliffe Hospital, Oxford, UK), Peter Reimer (Municipal Clinic Karlsruhe, Karlsruhe, Germany) and Christoph Binkert (MRI Bahnhof Oerlikon, Zurich, Switzerland).

Once patient enrolment is complete, an additional two years will be dedicated to the collection of patient follow-up data to ensure the study meets its objectives. Currently, there are several sites enrolled from Germany and the UK. More centres from Germany, the UK, France, Austria, Italy, Greece and Canada are in the recruitment process and are expected to join soon.

Next Research, CIRSE’s contract research organisation (CRO), is the administrator of CALCIO and is managing the study on a day-to-day basis, the press release states. Their team asked the CALCIO initiators and principal investigators to share their thoughts on the study’s significance, their experiences so far, and the importance of generating more clinical evidence. They also encouraged other centres to participate in this research effort.

Binkert shared: “I think CALCIO is an important registry because it collects real-world data on a very severe problem, as patients with CLTI need to get revascularisation and if they have very calcified arteries, this is a big challenge and the current evidence is not sufficient.”

Reimer said: “As interventional radiologists, we should learn to collect outcome data that looks at the long-term prognosis of patients. This is exactly what we will do with the CALCIO study. We’ll look at the amputation rate and wound healing through the use of IVL. That is why we should all try to enrol as many patients as possible in the CALCIO study.”

it takes real-world patients with very wide inclusion criteria and very few exclusion criteria. I am also happy that the outcome measures are clinically focused. We are talking about CLTI patients, so these are patients with the risk of losing their legs, and we are looking at wound healing and also amputation-free survival. We are not necessarily focusing on how the lesion performs with IVL, but on how the patient does. Another exceptional thing about CALCIO is that we are looking at quality of life, which is quite unusual in such studies, and it would be very interesting to see how patients perceive their treatment and how it is affecting their quality of life.”

Joo-Young Chun, principal investigator (St George’s University Hospitals NHS Foundation Trust, London, UK), said: “I am very excited to be part of the study. What makes CALCIO quite unique is that

Raghuram Lakshminarayan (Hull University Teaching Hospital, Hull, UK) principal investigator, emphasised the significance of addressing calcification: “Calcification is a huge problem for the medical community, especially with peripheral arterial disease. We saw this in the pulmonary system, and we now realise that this is a major issue in peripheral arterial disease, and IVL has come as a new technique in order to try to deal with this problem of calcification in peripheral arteries. CIRSE has set up this unique registry to look at exactly how IVL is going to work over a period of time. There have been a lot of studies, but we want to have a large population to look at over a long period of time for us to get to the bottom of how IVL modifies calcium and the outcomes when we treat these patients. CALCIO is a great registry, and I think you should add every patient with CLTI to this study!”

First patients treated in US GPS study of Paradise renal denervation system

The first patients in the USA have been treated in Recor Medical’s Global Paradise System US Post Approval Study (US GPS), a real-world study gathering data on the long-term safety and effectiveness of ultrasound renal denervation.

Antonio Gutierrez is the primary study investigator at Durham VA Medical Center (Durham, USA), the first US site in the study to enrol and treat patients.

The study will focus on gathering real-world safety and effectiveness data over five years from up to 1,000 patients, collaborating with research centres to help advance diversity and health equity within clinical trials.

Building upon the substantial clinical data generated to-date, which led to US Food and Drug Administration (FDA) approval of the Paradise system in November of 2023, the study will collect data on patients who undergo treatment with the Paradise system.

The study seeks to enrol patients from historically underserved populations in clinical trials, including racially diverse groups, women, and the elderly, along with those having significant comorbidities like chronic kidney disease and diabetes.

Shockwave lithotripsy system

CGuard

NMPA approves SyMap renal denervation system for treatment of uncontrolled hypertension

China’s National Medical Products Administration (NMPA) has granted a Class III Medical Devices Certificate of Registration for the msRDN radiofrequency renal denervation system (SyMap Medical).

The msRDN system consists of a disposable renal artery radiofrequency ablation catheter, a console with both electronic stimulation and radiofrequency ablation function.

According to SyMap Medical, the system can accurately map the renal nerve sites to selectively denervate renal sympathetic nerves, and has a good match with the anatomical shape of the renal artery with additional flexible manipulability, guiding function, contrast injection, stimulation/mapping, temperaturecontrolled ablation and manual irrigation. Thus, the system can provide real-time feedback before, during and after a renal denervation procedure in order to achieve selective ablation of renal sympathetic nerves.

The safety and efficacy of the msRDN system for treating patients with uncontrolled hypertension have been demonstrated by the SMART trial, which was led by Huo Yong (Peking University First Hospital, Beijing, China), Ge Junbo (Zhongshan Hospital, Fudan, China) and Sun Ningling (Peking University People’s Hospital, Beijing, China). The msRDN therapy achieved the goals of reducing the drug burden of hypertension patients and controlling office systolic blood pressure <140mmHg, with only four targeted ablations per renal main artery. The results have been published in The Lancet/eClinicalMedicine

NMPA described the msRDN system as: “the world’s first renal artery radiofrequency ablation product that can map renal nerves, can provide accurate ablation positions for renal sympathetic denervation, and can also provide effective feedback during and after the procedure to examine the immediate effect of renal sympathetic denervation, meeting the needs of renal denervation in clinical practice.”

Centerline Biomedical receives US FDA 510(k) clearance for new IOPS Viewpoint catheter Centerline Biomedical recently announced that its Intra-Operative Positioning System (IOPS) Viewpoint catheter has received US Food and Drug Administration (FDA) 510(k) clearance. The Viewpoint catheter is the most recent addition to the company’s patented IOPS portfolio.

A press release details that Viewpoint—a low-profile 6-French catheter available in multiple tip shapes and lengths—is designed for precision access to provide three-dimensional (3D) navigation feedback to clinicians.

When Viewpoint catheters are used in combination with the proprietary algorithms of the IOPS software, Centerline Biomedical explains, clinicians can clearly visualise endovascular tools in realtime and reduce their dependency on fluoroscopy systems. The result, according to the company, is state-of-the-art image-guided, real-time navigation designed to revolutionise the way endovascular procedures are performed. This is achieved while reducing exposure to harmful radiation emitted from the X-ray fluoroscopy systems that are typically used to see vessels during these procedures.

The press release continues that, at its core, the IOPS platform is designed to enhance visualisation, minimise procedure times, and reduce total radiation exposure for the benefit of both patients and healthcare providers.

“Development of our secondgeneration portfolio for IOPS has been the top priority for Centerline Biomedical. Viewpoint catheters were developed with input from leading clinicians to best meet their procedure needs,” said Gulam Khan, chief executive officer of Centerline Biomedical. “Our company continues to re-envision the field of endovascular interventions developing technologies designed with the express purpose of improving outcomes for both providers and patients.”

Life Seal Vascular awarded NSF SBIR grant to advance sac management technology for EVAR Life Seal Vascular recently announced that it has been awarded a National Science Foundation (NSF) Small Business Innovation Research (SBIR) grant. The funding will be used to accelerate the development of the company’s endovascular aneurysm repair (EVAR) technology.

“We are honored to receive this prestigious SBIR grant from the NSF. This funding is a testament to the innovative potential of our technology and our commitment to advancing EVAR care,” said Bob Mitchell, executive chairman of the board at Life Seal Vascular.

He continued: “With this support, we are well positioned to advance the development of our breakthrough aneurysm sealing solutions and make a significant impact on the lives of EVAR patients worldwide.”

Life Seal Vascular notes that the NSF SBIR grant will enable the company to further develop its proprietary aneurysmal sac sealing technology.

Designed as an adjunctive therapy to native endografts, Life Seal Vascular’s approach seals the entire aneurysmal sac potentially eliminating endoleaks, reducing reintervention rates and improving clinical outcomes for EVAR patients.

Vascular surgeon Michel Reijnen (Rijnstate Hospital, Arnhem, The Netherlands) commented on the significance of Life Seal Vascular’s technology, stating: “The advancements being made by Life Seal Vascular are truly remarkable. Their innovative solutions have the potential to revolutionise EVAR, offering patients safer and more effective treatment options. I am excited to see the positive impact this technology will have on the field and on patient care.”

Avicenna.AI secures European MDR certification for AI medical imaging portfolio

Avicenna.AI has received Medical Device Regulation (MDR) certification for five of its algorithms from British Standards Institution (BSI) Medical Devices—a development that means the company’s product portfolio is fully compliant with the European Union’s (EU) MDR 2017/745, which is now mandatory for medical device companies wanting to provide solutions in Europe.

As a press release from Avicenna. AI notes, the MDR was introduced to update the EU’s regulations for medical devices, addressing safety issues and the recent emergence of artificial intelligence (AI) tools and software as a medical device (SaMD), which did not exist when the old regulations were created. Ensuring MDR compliance is a critical component of obtaining and maintaining CE-mark status, allowing a device to be freely traded in the EU, the release adds.

Compared to the previous Medical Device Directive (MDD), the MDR has a wider scope and more stringent requirements. It emphasises clinical evaluation, postmarket surveillance, device traceability, rigorous technical documentation, and risk management,

according to Avicenna.AI. These measures aim to enhance patient safety and ensure high standards for medical devices, including AI and softwarebased solutions.

Avicenna.AI’s products have been certified as class IIb medical devices, which require a high level of clinical validation.

“Obtaining MDR certification is a significant milestone for Avicenna.AI,” said Stéphane Berger, regulatory manager at Avicenna.AI. “It demonstrates our commitment to meeting the highest standards of medical device safety and performance. This certification not only reinforces our dedication to compliance but also assures our customers of the quality and reliability of our AI product portfolio.”

The company’s newly MDRcertified AI tools include algorithms for intracranial haemorrhage (CINAICH), large vessel occlusion (CINALVO), quantification of stroke severity (CINA-ASPECTS), aortic dissection (CINA-AD), pulmonary embolism (CINA-PE), and opportunistic cases of pulmonary embolism (CINA-iPE). All of these products are CE-marked as well as being US Food and Drug Administration (FDA)-cleared, the release states.

“Crucially, despite the differences in SaMD regulatory requirements between authorities in the USA and Europe, we are consistently achieving both FDA and CE-mark clearance for our AI products,” Berger added.

Humacyte’s ATEV granted US FDA Regenerative Medicine Advanced Therapy designation for advanced PAD Humacyte recently announced it has been granted Regenerative Medicine Advanced Therapy (RMAT) designation from the US Food and Drug Administration (FDA) for its investigational acellular tissue engineered vessel (ATEV), designed to treat patients with advanced peripheral arterial disease (PAD). This RMAT designation was granted at the same time as the FDA cleared a new Investigational New Drug (IND) application for the PAD indication for ATEV, formerly referred to as the human acellular vessel (HAV).

According to Humacyte, this is the third RMAT designation granted by the FDA for Humacyte’s ATEV, in addition to previous RMAT designations for vascular trauma repair and arteriovenous (AV) access in haemodialysis.

Life Seal concept

IOPS cart

Acellular tissue engineered vessel

Industry News

Mitchell Silver joins Contego Medical as chief medical officer Contego Medical recently announced that Mitchell Silver, an interventional cardiologist and vascular medicine specialist, has joined the team as chief medical officer (CMO). A press release notes that Silver will play a pivotal role in shaping the company’s clinical strategy and advancing the portfolio of carotid and thrombectomy products.

“His medical leadership and strategic guidance will help guide clinical development, regulatory affairs, and commercialisation efforts for the upcoming launch of the Neuroguard IEP system carotid stent delivery catheter, Neuroguard IEP Direct transcarotid revascularisation system, and Excipio peripheral thrombectomy devices,” the release reads.

Silver brings extensive experience in cardiovascular and vascular medicine and specialises in managing arterial, venous, and lymphatic diseases.

Conference calendar

6 September

Interdisciplinary Aortic Dissection Symposium London, UK aorticdissectionsymposium.com

14–18 September

Cardiovascular and Interventional Radiological Society of Europe (CIRSE) annual congress Lisbon, Portugal cirsecongress.cirse.org/about/ theannualcongress

Before joining Contego Medical, he was at OhioHealth Heart and Vascular Physicians in Columbus, USA, where he was the director of the Center for Critical Limb Care and Endovascular Research. Silver founded the Cornwell Center for Cardiovascular and Diabetes Care at Ohio University (Athens, USA).

His contributions to the field include over 100 peer-reviewed manuscripts and book chapters on carotid artery atherosclerosis, peripheral vascular disease, and venous thromboembolism.

He has been a proponent of carotid artery stenting since the mid-1990s and contributed to research efforts to develop the first embolic protection device. Over the past decade, Silver’s research focused on deep vein thrombosis (DVT) and pulmonary embolism (PE). He served as the national principal investigator (PI) for the FLAME study, the largest prospective study of interventional treatment in high-risk PE and coprincipal investigator of CLEAR DVT, an international study on acute DVT management.

Silver’s collaboration with Contego Medical dates back to the company’s inception. He served on the company’s board in the early days. “Joining Contego brings my career full circle,

24–27 September European Society for Vascular Surgery (ESVS) annual meeting Kraków, Poland esvs.org/events/annual-meeting

26–27 September

Vascular Access Society of Britain and Ireland (VASBI) annual scientific meeting Cardiff, UK vasbi.org.uk/annual-scientificmeeting-2024

and I am energised to join the team at this important time in the company’s trajectory,” he said.

Joseph Bavaria joins board of directors at PECA Labs

PECA Labs has added Joseph Bavaria (Jefferson Health and Sidney Kimmel Medical College, Philadelphia, USA) to its board of directors. Bavaria, a cardiac surgeon, will provide leadership to PECA as it continues to develop and commercialise cardiovascular implants based on its novel tunable polymeric material platform.

He brings more than 30 years of experience in cardiac and thoracic surgery, research and leadership to PECA’s board. He is currently chair of Cardiac Surgery at Jefferson Health and executive director of the Jefferson Heart and Vascular Institute in Philadelphia.

Previously he spent more than three decades at Penn Medicine where he served in a number of leadership roles, including vice chief, Division of Cardiovascular Surgery, director of the thoracic aortic surgery programme, co-director of the transcatheter valve programme, and founder of the Penn Aorta centre.

(STS), president of the Thoracic Surgery Foundation (TSF), board member of the Heart Valve Society, and executive committee member of the European Association of CardioThoracic Surgery (EACTS).

“Dr Bavaria’s extensive leadership in cardiovascular surgery, particularly in innovating valve repair and replacement, will be immeasurable as we continue to develop and commercialise our MasaValve and our Stealth valve technologies,” said Doug Bernstein, CEO of PECA Labs. “Few have the combination of hands-on, research and educational experience as Dr Bavaria, making him an enormous asset as we move closer to our goal to provide devices that reduce or eliminate the need for replacement surgeries, thereby reducing the risk of morbidity and mortality in at-risk patients.”

PECA Labs’ MASA valve is a durable polymeric valved conduit for pulmonary valve reconstruction. Designed for paediatrics, the MASA valve is designed to help patients avoid repeat surgeries and reduce morbidity and mortality.

Bavaria has completed extensive research and served in international leadership positions including president of the Society of Thoracic Surgeons

3–5 October SITE Symposium Santiago de Compostela, Spain sitesymposium.com

7–8 October CX Aortic Live Vienna, Austria cxaortic.com

3–6 November Vascular Interventional Advances (VIVA) Las Vegas, USA viva-foundation.org/vivaprogramming

19–23 November VEITHsymposium New York, USA veithsymposium.org/index.php

The novel polymeric valve previously received Humanitarian Use Device (HUD) and investigational device exemption (IDE) from the US Food and Drug Administration (FDA).

27–29 November

The Vascular Societies’ annual scientific meeting (VSASM) Brighton, UK vascularsociety.org.uk/annualmeeting

12–14 December Paris Vascular Insights (PVI) Paris, France paris-vascular-insights.com

Mitchell Silver

Joseph Bavaria

Advancing Fenestrated Horizons

Expanded Patient Applicability

چ 3 piece system provides maximum planning flexibility

چ Low profile expands patient applicability (19F OD)

Procedural Accuracy & Efficiency

Cannulate from above for procedural ease and efficiency

Ability to axially and radially reposition graft while partially expanded

technical success 1 90% target vessel patency 1 98%

(146/149)

Freedom to position up to 5 fenestrations accommodates a variety of anatomies

Radiopaque markers for improved visualisation and alignment accuracy

Fenestration position and main body design can be widely customised according to specific preoperative anatomy. 2