Vascular News 95 – September 2022 OUS Edition

September 2022 | Issue 95

Featured in this issue:

www.vascularnews.com

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CX Aortic Vienna What to expect

Profile: Joseph S Coselli

Research continues to illuminate the effect of centre volume on aortic outcomes, with studies published and presented in the last few months pointing to an inverse relationship between failure to rescue (FTR)—an outcome measure that has gained ground in recent years—and hospital volume. This research, coupled with evidence that hospitals are not meeting recently proposed volume thresholds, has put into sharp focus the need to increase adherence to guidelines and discuss the future of open aortic surgery on an international level.

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volume centres had a “significantly greater risk” of FTR after elective OAR and “should either refer patients to higher volume centres or invest in resources designed to reduce the incidence of in-hospital death after complications”.

The authors note that FTR has emerged as an “attractive volume-associated alternative predictor Kevin of outcomes” to postoperative Mani in-hospital mortality as it “reflects overall team and hospital-system performance”. They add that, as a composite measure, FTR is “less sensitive to adjustment errors and might further improve discrimination for interhospital quality comparisons”. The investigators claim that theirs was the first study to explore FTR rates within the context of the endorsed SVS OAR volume thresholds and to focus on specific complications events.

More research on the utility of FTR as an outcome measure for aortic surgery is emerging. At the Charing Cross (CX) International Symposium 2022 (26–28 April, London, UK), Kevin Mani (Uppsala University, Uppsala, Sweden) proposed in a Podium 1st presentation that FTR may complement mortality as an outcome measure for

Local and national adaptations are necessary when setting threshold targets for minimum volume of procedures for aortic centres.”— Kevin Mani

Intraoperative vascular mapping

page 20

The centre volumeoutcome relationship in aortic surgery: Time for international discussion

n a recent study by Salvatore T Scali (University of Florida, Gainesville, USA) and David H Stone (Dartmouth-Hitchcock Medical, Lebanon, USA) et al, approximately one third of nearly 10,000 patients in the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) database who had Salvatore undergone elective open abdominal T Scali aortic aneurysm (AAA) repair (OAR) had undergone surgery at hospitals performing fewer than the SVSendorsed volume threshold of 10 procedures per year. This accounted for over 70% of participating centres.

Writing in the August edition of the Journal of Vascular Surgery (JVS), the authors add that the centres in the highest volume quartile (i.e. more than 10 procedures per year) had a 50% lower risk of failure to rescue (FTR; odds ratio [OR], 0.48; 95% confidence interval [CI], 0.3–0.8; p=0.004). The number and types of complication were “significantly associated” with the outcome risk, with colonic ischaemia versus renal complications (OR, 5.6; 95% CI, 1.9–16; p=0.001) and a return to the operating room for bleeding (OR, 11.9; 95% CI, 4.3–33; p<0.0001) having the greatest effect on predicting for FTR, they communicate in the Editor’s Choice paper.

According to Scali and Stone, there has been “ample” focus on surgeon volume to date, but less attention on the effect of centre volume, and specifically whether centre volume might be a “better proxy” for high-quality aortic care. In order to address this gap in the discussion, the research team aimed to measure the association of centre volume on OAR outcomes and FTR, which they defined as in-hospital death after the occurrence of a complication (i.e. cardiac, stroke, pulmonary, renal colonic ischaemia, return to the operating room for bleeding) and calculated the annual centre volume for 218 hospitals.

The authors conclude that their findings “highlight the utility of centre volume as an effective proxy to ensure high-quality aneurysm care”. They stress that lower

Yana Etkin:

page 29

Study is first to elucidate lower limb amputation epidemiology in a Latin American low- and middleincome country

A study recently published in the World Journal of Surgery claims to be the first to provide comprehensive population-level data on the epidemiology of lower extremity amputation (LEA) in a Latin American low- and middleincome country (LMIC). The investigators write that their data, which focus on the Brazilian state of Sao Paulo, are “crucial to plan strategies to reduce the burden of LEA”.

“LOWER LIMB AMPUTATIONS represent a high social, economic and health burden,” Rodrigo Bruno Biagioni (Hospital do Servidro Público Estadual de São Paulo, São Paulo, Brazil) et al write. According to the authors, most lower limb amputations are preventable, and reflect areas for improvement in healthcare. For these reasons, they stress that it is “essential” to know the epidemiology of these amputations, underscoring the rationale behind their study.

The investigators detail that LEA rates are “highly variable” across the world and that LEA trends are “conflicting”. These factors, they say, necessitate population-based studies in particular, “not only to truly know the local epidemiology of LEA, which reflects the quality of the health system, but also to build a global panorama in order to establish standards and goals.”

According to the authors, several countries in Europe, North America and Australasia have reported their amputation epidemiology, with most data coming from high-income countries (HICs). “Data from [LMICs] are scarce,” they write, noting that, to the best of their knowledge, in Latin America no such study existed before the present analysis.

“The paucity of data on LEA in LMICs is of particular concern,” the researchers note, “as the burden of PAD and [diabetes mellitus] is increasing an rates higher in LMICs than those observed in HICs.” Continued from on page 6

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September 2022 | Issue 95

Cover Story

The centre volumeoutcome relationship in aortic surgery: Time for international discussion Continued from page 1

aortic surgery. This research was also published in the Annals of Surgery.

Mani and collaborators studied intact AAA repairs performed in two large registries, assessing complications after aortic repair, FTR complications, and the relation to surgical volume, including more than 60,000 intact AAA repairs performed in eight countries.

The presenter revealed that FTR occurred in 10–12% of the patients suffering a complication. When looking at the relationship between volume and FTR, it was clear that increasing volume resulted in a lower FTR rate, Mani told the CX audience.

“In conclusion, the current analysis suggests that the volume-outcome relationship in aortic surgery is driven at least in part by the preparedness to promptly recognise and manage complications,” Mani said. “As such, FTR is a quality assessment marker that reflects processes of care in aortic surgery for both open repair and EVAR [endovascular aneurysm repair], and complements mortality as an outcome.”

The future of open aortic surgical care

In light of the growing body of research pointing to high volume as a “proxy” for high-quality aortic care, the question experts are asking now is: what do these results mean for the future of open aortic surgical care?

Based on the outcomes of their study, Scali, Stone et al write that it would be “prudent” for lower-volume centres that continue to offer elective OAR to consider investing in resources focused on supporting appropriate ‘prehabilitation’ and postoperative rescue therapies for high-risk patients and to target high-impact complications.

They believe that surgeons at these lower volume centres “should preferentially model their patient selection and technical operative conduct on the practices most commonly used at high-volume centres to improve outcomes”.

In an editorial accompanying the JVS paper, Shernaz S Dossabhoy (Stanford University School of Medicine, Stanford, USA) and Thomas L Forbes (University of Toronto, Toronto, Canada) underline the importance of providing high-quality open aortic surgical care in the endovascular era.

Addressing the topic of prehabilitation noted by Scali et al, Dossabhoy and Forbes believe that the USA has “lagged behind general surgery and other surgical

specialities” in this regard. However, they reference two recent society initiatives in the USA that are “pushing the needle” and changing clinical practice. First, they note that a joint SVS/American College of Surgeons Vascular Center Verification Program began its pilot phase in August 2021 to assess the quality of vascular inpatient and outpatient care facilities with the emphasis on verifying an institution’s quality improvement processes and its adherence to standards and protocols. They also mention Katharine McGinigle (University of North Carolina at Chapel Hill, Chapel Hill, USA) and colleagues, who recently produced the first set of joint SVS/Enhanced Recovery After Surgery (ERAS) guidelines, which Dossabhoy and Forbes remark represent a “landmark contribution to improving and standardising postoperative protocols and pathways for our vascular surgery patients”.

Scali and Stone also raise the question of centralisation to high-volume centres, which they state “has always been the overriding concept endorsed by societal guidelines, payors, and patient-safety organisations”. In the USA, however, they note that there are “significant geographic, socioeconomic, physician workforce, and patient preference barriers” that exist, preventing centralisation from occurring routinely. “These barriers are reflected in the observation that a substantial proportion of VQI OARs is conducted at lower volume facilities.”

Dossabhoy and Forbes caution that centralisation might not be a straightforward solution. They note that the downsides and training implications must be considered, for example.

Speaking to Vascular News, Kevin Mani noted that the topic of centralisation necessitates wider discussion due to variations on an international level. For example, he mentioned that the UK has adopted centralisation, while in Germany “this is not the case at all”.

“It is time for us to take that discussion internationally,” Mani said. Society recommendations might be a good starting point here, he commented, noting that the European Society for Vascular Surgery (ESVS) guidelines are currently being rewritten, however he stressed that these “are not the law” and that the discussion will require nuance due to the “controversial” nature of establishing a threshold for what is acceptable.

Mani elaborates: “Centralisation of aortic surgery to higher-volume centres can improve outcome, both in terms of management of complications and subsequently reduced perioperative mortality. However, the centralisation of aortic services may also result in patients having to travel further distances for treatment, an issue that can be critical in the acute setting. Therefore, reorganisation of aortic services will have to take into account population demography and local conditions including geography and distances. Therefore, local and national adaptations are necessary when setting threshold targets for minimum volume of procedures for aortic centres.”

News in brief

The latest stories from the vascular world

n ABDOMINAL AORTIC ANEURYSM RCT: In the abdominal aortic aneurysm (AAA) Get Fit randomised controlled trial (RCT), researchers Adam Haque (Manchester, UK) and colleagues found that a patient-directed, community% based exercise programme significantly improved the cardiopulmonary exercise testing parameters associated with impaired perioperative and long-term survival in patients following AAA repair. Trial results were recently published in the European Journal of Vascular and Endovascular Surgery.

Ruptured

AAA

carries a mortality rate of up to

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For more on this story go to page 10. n CAROTID ARTERY STENTING: Research from Ochsner Health (New Orleans, USA) published in the Journal of the American College of Cardiology details significant advances in the field of carotid stenting. It concludes that the data “support updating the [US] national coverage decision for carotid stenting from the Centers for Medicare and Medicaid Services to equal coverage for carotid surgery”. Pictured Christopher White

For more on this story go to page 19.

n DEEP VEIN THROMBOSIS TRIAGE: In a prospective, controlled clinical trial of deep vein thrombosis (DVT) using artificial intelligence-guided software simulating compression ultrasonography, lead investigator Efthymios Avgerinos (Athens, Greece) and colleagues demonstrated a high sensitivity and specificity in DVT diagnosis.

Avgerinos recently presented this finding at the 22nd European Venous Forum (EVF) annual meeting (30 June–2 July, Venice, Italy).

For more on this story go to page 24.

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September 2022 | Issue 95

Top Stories

Study is first to elucidate amputation epidemiology in a Latin American low- and middleincome country Continued from page 1

Biagioni et al’s study was a retrospective, population-based, cross-sectional analysis on all lower limb amputations performed in public hospitals in Sao Paulo—the most populous Brazilian state—between 2009 and 2020. The authors relay that they used a public database to evaluate types, rates and trends of the amputations performed, main aetiologies leading to the indication for amputation, hospital length of stay and in-hospital mortality rates, demographics of the amputees and procedure costs.

Main findings

The study included data on 180,595 lower limb amputations and surgical revisions of amputations, with toe amputations (45%) and major amputations (33%) being the most frequent types of surgeries.

Biagioni and colleagues report a significant increase in the rates of both of these procedures. They add that peripheral arterial disease (PAD) was found to be the most frequent underlying diagnosis for LEA, followed by diabetes mellitus, with an increasing trend for both over the last 12 years. Furthermore, they also observed seasonality in procedure rates, with peaks in August in all years.

The authors also reveal that most patients were male (69.3%), Caucasians (55.6%) and elderly.

Other findings included a 6.6% rate of in-hospital mortality and lower limb amputations and total of US$67,675,875.55 reimbursed by the government.

Based on these findings, the authors propose some preventive strategies—namely foot ulcer screening, multidisciplinary diabetic foot care, and encouraging revascularisation procedures, which, they claim, have not significantly increased in the city of São Paulo, the

capital of the state of Sao Paulo, since 2008. with any database-driven study. In addition, In the discussion of their results, the they acknowledge that their data represent research team considers some possible only the state of Sao Paulo, which depends explanations for PAD being the main solely on the public health system. “An underlying diagnosis for all LEA in Sao Paulo, integrated database covering data from public one of which is that Brazil is “late in the and private health systems would be more epidemiological transition concerning LEA”. comprehensive,” they note.

They predict that it is likely Brazil will reach similar statistics to those found in most recent Knowledge of the data nationwide studies—which point to diabetes “essential” mellitus as the most common underlying Speaking to Vascular News, corresponding Data cause of LEA—in the coming years, as the authors Andressa Cristina Sposato Louzada on prevalence of smoking is reducing and that of and Nelson Wolosker (both Hospital Israelita diabetes mellitus is rising.

Albert Einstein, São Paulo, Brazil) Furthermore, Biagioni et al address comment on the study findings: the finding that August showed the “Knowledge of the data is essential highest number of amputations in all for decision-making by public years of their study. They write that, policy managers. Knowing the although this contrasts a previously real amputation rates, increased Lower limb reported finding from Hong Kong investment in risk factor amputations and of higher LEA frequency due to controls, and increased access to surgical revisions of diabetes mellitus during the summer, revascularisation become the most amputations, with in this study the main underlying obvious attitudes. Soon, adopting such diagnosis was PAD, and it is possible attitudes, amputation rates will probably there may be a worsening in PAD during decrease. This way, Brazilian society can winter. They elaborate: “Even though evolve, an example for other countries.” impaired circulation of lower limbs is documented for venous insufficiency, it is toe reasonable to think it may also play a role Key points amputations in arterial insufficiency.”

The authors recognise there are some Retrospective, population-based, cross-sectional analysis on all limiting factors to their study, including the and lower limb amputations performed accuracy of their findings being “susceptible in public hospitals in the state of to inherent miscoding or data entry errors,” as

180,595 45%

Knowledge of the data is essential for decision-making by public policy managers.”— Nelson Wolosker

Vascular experts establish appropriate use of IVUS in peripheral interventions

33%

major amputations being the most frequent types of surgeries

and treatment of peripheral vascular disease.”

Peripheral vascular disease affects an estimated 200 million people worldwide, including approximately 40 to 45 million Americans, according to the American Heart Association. The authors noted The first-ever global consensus guidance for the appropriate use that minimally invasive approaches for of intravascular ultrasound (IVUS) in lower extremity arterial and peripheral vascular disease interventions venous interventions was recently published in the Journal of the are increasingly common, but traditional American College of Cardiology: Cardiovascular Interventions. imaging techniques like angiography have limitations, including THE NEW CONSENSUS on their extensive experience, two-dimensional projections of document from 30 global vascular arrived at a strong consensus,” three-dimensional vasculature, experts recommends routine use of said lead author Eric A Secemsky which can complicate IVUS as a preferred imaging modality (Beth Israel Deaconess Medical diagnosis and intraprocedural in all phases in many peripheral Center, Boston USA) in a optimisation. vascular disease procedures. The Royal Philips press release “As the global leader in results come ahead of the multi-society announcing the publication Eric A Secemsky providing vascular solutions roundtable sponsored by the Society of the consensus document. to physicians and the patients for Cardiovascular Angiography and “They recommend routine use they serve, we especially Interventions (SCAI) on peripheral of IVUS as a preferred imaging modality value the rigour and independence of IVUS in September and the upcoming in all phases for many peripheral this cross-specialty expert consensus,” publications of a large-scale realinterventions, both diagnostic and said Heather Hudnut Page, general world health outcomes study presented therapeutic, as it enables such exquisite manager and business leader for at Transcatheter Cardiovascular visualisation of the target vessel and peripheral vascular image-guided Therapeutics (TCT) 2021 (4–6 lesion. Their recommendations, which therapy devices at Philips. “It is exciting November, Orlando, USA). withstood the rigour of peer review, can to know that this initiative has the “The voting panellists considered a now be considered in the formulation potential to standardise the use of IVUS variety of clinical scenarios and based of clinical guidelines for the diagnosis in peripheral interventions and guide

Sao Paulo between 2009 and 2020 Biagioni et al report a significant increase in the rates of both toe and major amputations PAD was found to be the most frequent underlying diagnosis for LEA, followed by diabetes mellitus, with an increasing trend for both over the last 12 years The authors also observed seasonality in procedure rates, with peaks in August in all years

clinical decisions to further improve the quality of care procedures for patients.”

Supported in part by research grants from Philips and Boston Scientific, the study was conducted and analysed independently by Smith Center for Outcomes Research, gathering a wide spectrum of vascular expert opinion to ascertain the role of intravascular imaging in contemporary clinical practice.

The voting panellists considered a variety of clinical scenarios and based on their extensive experience, arrived at a strong consensus.”— Eric A Secemsky

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September 2022 | Issue 95

Education

CX AORTIC VIENNA

Cardiac and vascular surgeons collaborate at the vanguard of aortic care

move further and further into the ascending aorta with our endovascular techniques. This can only be done with the support of the cardiac surgeons, and this is the reason why we really look forward to CX Aortic Vienna because everyone comes together addressing this complex field.“

Talking points

CX Aortic Vienna returns in October for its third edition (24–26 October, Digital), bringing together world-leading specialists from the cardiac and vascular fields to discuss all facets of aortic care from selection to investigation, diagnosis, techniques and technologies. The meeting will showcase the latest approaches—open and endovascular—for the treatment of complex aortic problems spanning the aortic valve to the iliac arteries.

HAVING ATTRACTED A GLOBAL, ONLINE audience during its first two editions, CX Aortic Vienna will continue to reach out to the worldwide aortic surgery community. The 2022 edition features three days of high-quality digital programming, to be broadcast live from 24–26 October for the wider global audience, delivering a total of 15 hours of aortic education, which will also be available ondemand to registered attendees after the event.

The format for the digital edition will follow the CX style of short talks, debates, and audience interaction, presented live via broadcast. The programme includes open and endovascular aortic techniques and technologies, including edited aortic cases.

For the first time, the meeting will also offer an in-person component from its home city, Vienna, Austria, where CX Aortic Vienna has been invited to provide two 90-minute primetime cutting-edge English-language sessions for attendees of the Dreiländertagung—the joint meeting of the Austrian Society of Vascular Surgery (ÖGG), the Swiss Society for Vascular Surgery (SGG) and the German Society of Vascular Surgery (DGG)—on Thursday, 20 October.

Multidisciplinary approach

The importance of multidisciplinary aortic approaches will be a key strand running through CX Aortic Vienna’s content and discussion, and the 2022 event will continue its mission to bring together specialists of all skills—be they cardiac, vascular or endovascular—to provide a comprehensive overview of cutting-edge aortic treatment.

The programme encompasses discussion and debate spanning key talking points in the aortic space including aortic arch interventions, thoracic dissection, thoracic imaging, thoracoabdominal techniques, juxtarenal, abdominal aortic and iliac artery therapies.

“I have had the honour and the privilege during my career to treat the aorta from the aortic valve all the way to the femoral arteries,” notes Joseph Coselli (Houston, USA), who has been among the expert speakers to have participated in previous editions of CX Aortic Vienna and is returning in 2022. “The entire history of aortic surgery, and vascular surgery to the same extent, has been one of technical and clinical evolution.”

Coselli adds: “The Charing Cross meetings are among the best with regard to the broad spectrum

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World-leading faculty

The full programme has been curated by a Vascular, Endovascular and Cardiothoracic Executive board comprised of leaders in the field of aortic care including CX Aortic Vienna founding chair Roger Greenhalgh (London, UK), alongside Tilo Kölbel (Hamburg, Germany) who will moderate the inperson session at Dreiländertagung, Afshin Assadian (Vienna, Austria), Roberto Chiesa (Milan, Italy), Martin Grabenwöger (Vienna, Austria), Stéphan Haulon (Paris, France), Gustavo Oderich (Houston, USA), Markus Steinbauer (Regensburg, Germany) and Alexander Zimmermann (Zürich, Switzerland).

“This is, as always, a focus upon the aorta as managed by cardiac aortic surgeons, open vascular surgeons and endovascular surgeons; from the aortic valve at one end, to the iliacs at the other end,” says Greenhalgh of the event’s 2022 edition. “CX Aortic Vienna, for those of you who have been to it before, is for all of those who manage the aorta,” he adds. “This is not just the surgeons, but the physicians—we have radiologists, imaging experts, vascular scientists and vascular nurses. All who manage aortic patients are welcome to come and join us for the digital edition on 24, 25 and 26 October this year.”

“October is the time for aortic disease and to discuss newest trends, technologies and features in aortic therapy,” comments Kölbel. “We are focusing on both open and endovascular techniques and we are inviting the cardiovascular and vascular communities to come to CX Aortic Vienna, with a presence during the Dreiländertagung, and very much to the virtual event that happens a few days later.”

Roger Greenhalgh

We are focusing on both open and endovascular techniques

CX Aortic Vienna is for all of those who manage the aorta

“CX Aortic Vienna is the unique chance to get together with cardiac surgeons and all kinds of vascular specialists that are treating the aorta,” says Zimmermann, discussing the importance of the multidisciplinary focus at the heart of CX Aortic Vienna. “The problem is that we have a transition zone in the arch and we—as vascular surgeons—

Tilo Kölbel

Joseph Coselli

The entire history of aortic surgery has been one of technical and clinical evolution

of technology and clinical information and sharing among experts. I would invite everyone to take the opportunity to learn a lot about vascular and aortic surgery at CX Aortic Vienna.”

From 2023 onwards, CX Aortic Vienna will be held annually in October as a hybrid meeting in-person in Vienna whilst simultaneously livestreaming globally.

ai16599530025_CX 2022 Aortic - Reg Now.pdf 1 08/08/2022 11:03:24

AORTIC VIENNA CLASSICAL OPEN AND ENDOVASCULAR SOLUTIONS

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REGISTER NOW

CX Aortic Vienna was a revolution in aortic approaches and updated our knowledge in the speciality

All the speakers were excellent. It was a perfect overview, and I was able to look back at the sessions on-demand

cxaortic.com

It was a great use of my time. Intensive learning!

10 Randomised Controlled Trials

AORTIC

September 2022 | Issue 95 including advice on weight loss and exercise. They assessed the primary outcome of change in peak VO2 at 24 weeks, and secondary outcomes including AT, VECO2, cardiovascular biomarkers, body mass index (BMI) and health-related quality of life.

Follow-up was conducted at eight, 16, 24 and 36 weeks.

The authors reveal in the EJVES 2–3%. “This mortality, and that the CEP patients (n=28) long-term survival, is achieved mean (95% Ruptured associated with impaired confidence interval) peak oxygen uptake (peak improvements from VO2), oxygen uptake at carries a mortality baseline in peak VO2 of 1.5 anaerobic threshold (AT) (0.5, 2.5), 2.1 (1.1, 3.2), 2.3 rate of up to and ventilatory equivalent (1.2, 3.3) and 2.2 (1.1, 3.3) for CO2 at AT (VECO2) on ml/kg/min at eight, 16, 24 and CPET,” Haque et al explain.

36 weeks, respectively. “These “Improving fitness to optimise % changes in CEP patients were these variables could improve significantly greater than those perioperative and long-term seen in controls at 16 (p=0.002), survival, but the required exercise 24 (p=0.031) and 36 weeks (p<0.001),” training suitable for AAA patients, they add. In addition, Haque et al has yet to be established,” they write. observed “significant” improvements The investigator’s AAA Get Fit in AT, triglyceride levels and healthprospective RCT aimed to evaluate related quality of life in CEP patients. the effectiveness of 24-week, patientAccording to the investigators, the directed, community-based exercise AAA Get Fit trial has a number of on CPET-measured fitness in AAA limitations. They state, for example, surveillance patients. that peak VO2 at baseline was Haque and colleagues report that “significantly greater” in controls they randomly assigned patients on than in CEP patients, which occurred AAA surveillance at a tertiary UK despite minimising on randomisation vascular centre (n=56) to either a 24for peak VO2 more or less than 15ml/ week community exercise programme kg/min—i.e. equivalent to the threshold (CEP) with choice of gym or home associated with perioperative survival. exercises or standard clinical care “What effect this would have on the

Community-based exercise programme reduces AAA morbidity and mortality in randomised trial RESULTS OF A RANDOMISED controlled trial (RCT) point to the beneficial effects of a community-based exercise programme on outcomes in patients with an abdominal aortic aneurysm (AAA).

Researchers Adam Haque (Manchester University NHS Foundation Trust, Manchester, UK) and colleagues found that a patientdirected, community-based exercise programme significantly improved the cardiopulmonary exercise testing (CPET) parameters associated with impaired perioperative and longterm survival in patients following AAA repair. They observed that the improvements were maintained at 12 weeks following the end of the programme.

In an article published online ahead of print in the European Journal of Vascular and Endovascular Surgery (EJVES), the authors note that ruptured AAA carries a mortality rate of up to 80%. They state that elective repair prevents rupture, however perioperative mortality remains at

Multicentre, randomised SUNDAY trial set to analyse uncomplicated aortic dissection therapy Jacob Budtz-Lilly (Aarhus University, Aarhus, Denmark), principal investigator of the Scandinavian trial of uncomplicated aortic dissection therapy (SUNDAY) speaks to Vascular News about the background and aims of this upcoming multicentre, randomised study.

Can you provide a brief overview of the SUNDAY trial and how the idea came about?

This trial will address the question of whether thoracic endovascular aortic repair (TEVAR) alters five-year survival among patients with an uncomplicated type B aortic dissection. We hope to include around 600 patients from 21 centres across Denmark, Sweden, Norway, Finland and Iceland.

Aortic dissection is one of my main interests, and at meetings I kept hearing it said that we need a randomised controlled trial to assess survival in these patients. I honestly heard this more than 10 times.

About a year and a half ago, I decided to initiate the idea. I knew that this could be an expensive, complicated and generally difficult trial to see through. In order to make it possible, we decided to simplify the design by omitting morphological

AAA

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changes as one of the endpoints, of which we already have a lot of good data. Of course, all of these patients undergo multiple imagings, but by removing them from the outcomes, we removed the need for expensive and time-consuming core lab work. This was not an immediately popular decision, but we talked it through, and worked it out that we could conduct the trial in this simplified way. In addition, all the countries involved in the trial have similar healthcare models, and we all capture dissection patients pretty well too. All of these factors made for a good starting point.

What does the literature say on the topic of uncomplicated aortic dissection?

I would say there are three main outcomes that are addressed in the literature. The most important of these is survival, particularly long-term, and there are two key trials that have looked at this outcome. The ADSORB trial, which focused on acute dissection, was relatively small and showed no benefit of survival. The INSTEAD trial, which was extended to the INSTEAD-XL trial, suggested that there is a survival benefit. This trial was similar to ours, although it was smaller in size than what we propose.

The second outcome is aortic morphology. The ADSORB trial and the INSTEAD trial, as well as some retrospective studies, document that early intervention improves morphology, and I think it is now well accepted that intervention is a good idea if you want to improve morphology.

The final thing, which is gaining importance, is quality of life. I think we all recognise that patients with dissections have a high level of anxiety and that perhaps early intervention could improve this. Related to this, and also gaining attention, is

patients’ ability to improve their fitness is open to conjecture,” Haque and colleagues remark.

Haque et al also recognise that patients who agree to take part in research “tend to be more motivated than those that refuse”. They note that, although both recruitment and attrition rates were “better than that achieved by previous research on exercise training in AAA patients,” the majority of patients (61.2%) declined to take part.

“Efforts to improve this rate would need to be made to maximise effectiveness in clinical practice,” the authors acknowledge, however they stress that it is “difficult to explore specific reasons” behind the low rate of uptake, as there were no significant differences in demographics between those that did and did not agree to take part.

Concluding, Haque et al anticipate that the results of this RCT “should now inform definitive multicentre RCTs with the aim of investigating the effect of improving CPET parameters with CEP on all potential clinical outcomes in AAA surveillance patients, including perioperative morbidity and mortality, cardiovascular risk, healthrelated quality of life and all-cause mortality”. Such studies, they add, would also need to include robust cost-effectiveness analyses and “may ultimately provide evidence to support the widespread implementation of CEP to improve outcomes for all individuals with AAA”.

discussion around the costs of early versus later intervention.

What do you anticipate you might find, and when can we expect results?

I am always a bit reluctant to let my personal biases enter into a scientific query, but to be open, I do think that this trial will show that TEVAR offers a survival benefit in uncomplicated aortic dissection patients. What really interests me, however, is what details may emerge from various trend and subgroup analyses, which is possible if and when a trial of this size is carried out. For example, given the good capture of dissection patients in the

The question of long-term survival is obviously paramount, but the details of who, what, why, and when will also be of great interest.”

Nordic countries, it will be extremely interesting to evaluate the screening of these patients in order to identify data on complicated versus uncomplicated and various risk factors associated with safety and reinterventions. The question of long-term survival is obviously paramount, but the details of who, what, why, and when will also be of great interest.

Our start date is 1 January 2023 and the estimated accrual period is three years. We expect to have oneyear follow-up on the entire cohort at the end of four years, so maybe early 2027.

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September 2022 | Issue 95

12 Endovascular Aneurysm Repair

AORTIC

F/BEVAR has high technical success and low mortality in chronic postdissection TAAA Fenestrated/branched endovascular aneurysm repair (F/BEVAR) is associated with high technical success and low mortality in patients with chronic postdissection thoracoabdominal aortic aneurysm (PD-TAAA). This conclusion was presented by Mohamed A Abdelhalim (St Thomas’ Hospital, London, UK), who detailed a multicentre, transatlantic experience with F/BEVAR for chronic PD-TAAAs during this year’s Society for Vascular Surgery (SVS) Vascular Annual Meeting (VAM 2022; 15–18 June, Boston, USA).

T

he study was co-authored by Emanuel R Tenorio and Gustavo Oderich (both The University of Texas Health Science Center at Houston, Houston, USA) alongside senior author Bijan Modarai (Guy’s and St Thomas’ NHS Foundation Trust, London, UK).

“F/BEVAR has been used widely in the treatment of thoracoabdominal aneurysms,” Abdelhalim told attendees, adding that PD-TAAAs present a unique set of endovascular technical challenges.The study aimed to analyse outcomes of F/BEVAR for treatment of chronic PD-TAAAs by reviewing clinical data of consecutive patients treated by F/BEVAR for Extent I-III PD-TAAAs in 16 centres from the USA and Europe from 2008‒2021. All patients received offthe-shelf or patient-specific manufactured fenestratedbranched stent grafts.

Endpoints for the study included any-cause mortality and major adverse events (MAEs) at 30 days, technical success, target artery (TA) patency, freedom from TA instability, minor (endovascular

with <12Fr sheath) and major (open or >12Fr sheath) he commented, overall patient survival at five years secondary interventions, and patient survival and (65%) reflects the fact that patients treated have freedom from aortic-related mortality (ARM). advanced age and significant comorbidities. Freedom Abdelhalim presented data from 246 patients from secondary interventions at five years was 44%, (76% male; median age 67 years [interquartile range although most were minor procedures and conversion (IQR) 61‒73]), who were treated for Extent I (7%), to open repair was needed in only one patient.

Extent II (57%) and Extent III (36%) PD-TAAAs “Fenestrated and branched EVAR can be used in (Median aneurysm diameter, 65mm [IQR 59‒73]) the treatment of chronic post-dissection aneurysms

by F/BEVAR. Of these, 18 patients (7%) were with low mortality and low morbidity,” Abdelhalim octogenarians, 212 (86%) were American Society said. “However,” he cautioned, “this does carry a of Anaesthesiologists (ASA) class ≥3, and 21 (9%) significant intervention rate, and because of this, a presented with contained ruptured or symptomatic bespoke approach is required for each patient, and this aneurysms. includes close follow-up and monitoring of Abdelhalim reported that there were the long-term outcomes.”

917 renal-mesenteric vessels targeted The importance of long-term The study reviewed by 581 fenestrations (63%) and 336 follow-up was a theme picked up clinical data of directional branches (37%), with a in the discussion following the mean of 3.7 vessels per patient. He presentation, during which a consecutive patients noted that technical success of the number of audience members treated by F/BEVAR for procedure was 96%. remarked on the significance of Extent I-III PD-TAAAs The author reported that the data presented by Abdelhalim. in 16 centres from the the study investigators found Speaking from the floor, Ian USA and Europe from “favourable” 30-day mortality Loftus (St George’s University 2008-2021 among the patient cohort, with a rate Hospital NHS Foundation Trust, of around 3%, whilst adding that MAEs London, UK) described these as “really occurred in 28%, including acute kidney important data” and echoed the point that injury in 8%, new-onset dialysis in 1%, major long-term outcomes are key. stroke in 1%, spinal cord injury in 7% and permanent “You have highlighted that these are very sick paraplegia in 2%, he noted. Mean follow-up was patients and it is very complex technology, and 24±23 months, wherein patient survival and freedom therefore [it] is very expensive and time consuming,” from ARM were 65±10% and 93±5% at five years, remarked Loftus. “How do you think that we can respectively. Secondary interventions were needed prove that we are altering long-term outcomes for in 93 patients (38%), Abdelhalim noted, including these patients, and how are we going to prove costminor procedures in 63 (26%) and major in 30 (12%). effectiveness of these technologies?” he asked.

There was one conversion to open repair (<1%), while “The follow-up in this cohort is two years, so the freedom from any secondary intervention was 44±9% only way to do that is for us to continue monitoring at five years. The five-year freedom from target artery these patients and see where we are in a number of instability was 82±3% and instability was significantly years from now,” Abdelhalim responded. more likely to affect branches than fenestrations.

Study co-author Oderich, who joined Abdelhalim Major causes included endoleaks and stenosis, the at the podium for the discussion, further remarked: “I presenter commented. In his concluding remarks, think what this shows is that we selected a very highAbdelhalim noted that F/BEVAR was associated with risk population, and that reflects the fact that it is the high technical success and low mortality (3%), newbeginning of the experience with fenestrated-branched onset dialysis (1%) and permanent paraplegia rates grafting. “As time goes by and we enrol patients that (2%) in patients with chronic PD-TAAAs. are intermediate or lower risk, I think we will be able Although the procedure is effective against ARM, to achieve a longer follow-up.”

Female sex is associated with reintervention and mortality following elective EVAR

Women are more likely to die within five years of having elective surgery to repair an abdominal aortic aneurysm (AAA) or need repeat surgery, according to a recent study.

WRITING IN THE JOURNAL of Vascular Surgery, Taylor Corsi (Rutgers University, Piscataway, USA) and colleagues say the disparity between men and women who undergo the surgery needs to be addressed by including women in early aortic aneurysm screening as well as incorporating more women in clinical trials of aortic medical devices.

“Despite the fact that men are more likely to be diagnosed with and to die from AAA, women are still underrepresented in many clinical trials for the aortic devices used in minimally invasive aortic aneurysm repair,” said William Beckerman (Rutgers

University, New Brunswick, USA), who led the study. “As men and women are known to have different aortic anatomy, this study highlights the need for an increased focus on, and inclusion of women in aortic device creation and subsequent trial enrolment.”

Researchers conducted a retrospective chart review of 273 patients—75% of them male and 25% female—who underwent endovascular aneurysm repair (EVAR) from 2011 to 2020 at a tertiary medical centre. The idea was to learn how many patients survived Taylor Corsi

five years beyond the surgery and how many needed reintervention. The females were older on average than the males and were more likely to have chronic obstructive pulmonary disease, require home oxygen therapy or dialysis.

Despite some variations in morbidities, the differences in survival and reintervention were statistically significant, the researchers found.

Females had significantly lower survival rates at five years as well as a higher rate of reintervention within those years.

“Our question was, knowing all these things that we do, do men and women have different outcomes—even though they are being operated on by the same surgeon, at the same hospital with the same devices?” Beckerman said.

“The answer to that was ‘yes.’ Men and women do differently after surgery.”

“Our data suggest factors beyond patient age and baseline health risk likely contribute to greater surgical morbidity and mortality for females following elective EVAR,” Beckerman said.

Our data suggest factors beyond patient age and baseline health risk likely contribute to greater surgical morbidity and mortality for females following elective EVAR.”

Issue 95 | September 2022

Aortoiliac Occlusive Disease Treatment 13

AORTIC

New data support covered stent use in complex aortoiliac occlusive disease treatment ONE-YEAR OUTCOMES FROM the BELSTREAM trial add to a growing pool of data that covered stents are safe and effective in the treatment of complex aortoiliac occlusive disease (AIOD).

At the Leipzig Interventional Course (LINC) 2022 (6–9 June, Leipzig, Germany), Koen Deloose (Sint Blasius Hospital, Dendermonde, Belgium) reported a primary patency rate of 94% and freedom from target lesion revascularisation (TLR) rate of 95% using the Lifestream balloonexpandable vascular covered stent (BD) in complex lesions.

Deloose highlighted that it was in 2008 when a study by Robert W Chang (Dartmouth-Hitchcock Medical Center, Lebanon, USA) et al first showed some advantage of covered stents over bare metal stents in the aortoiliac field. The study was published in the Journal of Vascular Surgery. He also referenced the randomised COBEST trial, in which covered stents performed better than bare metal stents in a subgroup of patients with complex TASC C and D lesions.

In order to further investigate the use of covered stents in AIOD, Deloose and colleagues initiated

the BELSTREAM trial with the Lifestream stent. The presenter noted that this stent has been studied in the treatment of AIOD once before, in the BOLSTER trial, but only in relatively uncomplicated lesions. This BOLSTER was a prospective, multicentre, singlearm study that included 155 patients from 17 sites across the world. The researchers of this study reported a freedom from TLR rate of 87.6% at

The primary patency rate at one year in this difficult TASC C and D patient and lesion cohort was 94.5%.” two years, according to Kaplan Meier analysis. “It is important to say that these were mainly TASC A and B lesions,” said Deloose, noting that the mean lesion length was 3cm and that there were occlusions in 21% of the cases.

Deloose informed the LINC audience

that BELSTREAM is cohort was 95.3%, and a prospective study that the corresponding being carried out in figure in the kissing six Belgian centres. configuration group Seventy patients, was almost 98%. “I with 133 lesions would like to remind in total, have been you that the freedom enrolled. The primary from TLR in the efficacy endpoint BOLSTER trial of is primary patency TASC A and B lesions of the target lesions and was 94.5%,” he said. one year without Deloose also Koen Deloose reintervention. conveyed the latest The primary safety clinical outcomes endpoint is freedom from procedurefrom the trial, noting a sustained ankleor device-related events—such as brachial index (ABI) progression and major amputation and clinically driven “very good evolution” in Rutherford TLR—at 30 days. categorisation. Speaking finally on The presenter was keen to stress the safety outcomes, he said that there were complexity of the patients included three clinically driven TLRs and four in the BELSTREAM trial, noting that deaths at 12 months, however none 41.4% had total occlusions, all of which were device or procedure related. were TASC C (20%) and D (20%). He “There is now more evidence added that the aortic bifurcation kissing that covered stents are performing configuration was performed in 77% of better in complex AIOD treatment,” cases—in “very calcified” lesions—and Deloose concluded. He summarised that pre-dilation was carried out in that the Lifestream covered stent has almost 40% of the cases. already been shown to be safe and Presenting 12-month data from the effective in treating “easier” TASC trial for the first time, Deloose reported A and B lesions in the BOLSTER at LINC that the primary patency rate at trial, and that the latest results one year in this “difficult” TASC C and from BELSTREAM “confirm these D patient and lesion cohort was 94.5%. findings in complex lesions”.

He noted that this figure rose to 97.4% A show of hands after Deloose’s talk in a subanalysis of the kissing stent suggested the audience were convinced cohort, which included 77% of the total by the data, with a majority of delegates patient population. in attendance at the session voting that In addition, the speaker revealed that they would use a covered stent as a freedom from TLR in the complete primary option in AIOD pathology.

Artificial intelligence can predict risk of complications after endovascular aneurysm repair Artificial intelligence (AI) models can be developed to predict the risk of postoperative complications after endovascular aneurysm repair (EVAR) with “high accuracy,” research presented at this year’s Society for Vascular Surgery (SVS) Vascular Annual Meeting (VAM 2022; 15–18 June, Boston, USA) demonstrated.

“C

omplications after EVAR can be fatal,” Becky Long (Central Michigan University, Saginaw, USA) informed attendees, noting in her presentation that patient follow-up for surveillance imaging is becoming more challenging as fewer patients are seen, particularly after the first year.

The aim of Long’s study was to develop an AI model to predict the complication probability of individual patients to better identify those needing more intensive surveillance. The research involved collecting preoperative computed tomography angiography (CTA) 3D reconstruction images of abdominal aortic aneurysm (AAA) from 273 patients who underwent EVAR from 2011‒2020.

Of these patients, 48 had postoperative complications including endoleak, AAA rupture, graft limb occlusion, renal artery occlusion, neck dilation, pelvic ischaemia, and graft migration.

Using a deep convolutional neural network model, the researchers utilised the 3D CT images to predict

the risk of complications after EVAR. The model was built with Tensorflow software and run on the Google Colab Platform.

A training subset of 40 randomly selected patients with complications and 189 without were used to train the AI model. Eight positive and 36 negative cases tested its performance and prediction accuracy.

This model can play an assistive role in identifying all patients at high risk for postEVAR complications and the need for greater compliance in surveillance.”

Data downsampling was used to alleviate data imbalance and data augmentation methodology to further boost the model’s performance.

Long’s presentation reported that successful Becky Long training was completed on the 229 cases in the training set and then applied to predict the complication probability of each individual in the held-out performance testing cases.

The model provides a complication sensitivity of 100% and identified all the patients who later developed complications after EVAR. Of 36 patients without complications, 16 (44%) were falsely predicted to develop complications.

The results, therefore, demonstrated excellent sensitivity for identifying patients who would benefit from more stringent surveillance and also alleviate the need for surveillance in 56% of patients unlikely to develop complications, the presentation showed.

This, Long concluded, demonstrates that AI models can be developed to predict the risk of postoperative complications with high accuracy.

“Compared to existing methods, the model developed in this study did not require any expertannotated data but only the AAA CTA images as inputs,” Long’s presentation showed. “This model can play an assistive role in identifying all patients at high risk for post- EVAR complications and the need for greater compliance in surveillance.”

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Issue 95 | September 2022

Guidelines 15

CAROTID

ESVS publishes 2023 guidelines on management of atherosclerotic carotid and vertebral artery disease The European Society for Vascular Surgery (ESVS) has released 2023 clinical practice guidelines on the management of atherosclerotic carotid and vertebral artery disease. The guideline document, authored by chairperson Ross Naylor (Leicester Vascular Institute, Leicester, UK), co-chairperson Barbara Rantner (Ludwig Maximilian University of Munich, Munich, Germany) and colleagues, has been published in the European Journal of Vascular and Endovascular Surgery (EJVES).

THE DOCUMENT CONTAINS 133 recommendations, including 38 that are new and 11 that have been ‘regraded’ since 2017, which is when the last ESVS guidelines on this topic were published. The manuscript contains 629 references, 289 of which are new (i.e. published between 2017 and 2022). Thirty-nine of the references are

from randomised controlled trials, 71 are systematic reviews and/or metaanalyses, and the references also include data from 50 vascular registries or quality initiative programmes.

In the document, the authors first address what is new in the 2023 guidelines. They write that each section has been revised or rewritten and that

Barbara Rantner

Ross Naylor

five new sections have been added, including management of free-floating thrombus; management of carotid webs; management of symptomatic patients with an ipsilateral 50–99% carotid stenosis and atrial fibrillation; planning carotid interventions in anticoagulated patients; and timing of carotid interventions in patients with acute ischaemic stroke undergoing thrombolysis.

Naylor, Rantner and colleagues add that the new guidelines highlight similarities and discrepancies with the 2021 American Heart Association guidelines on the management of stroke/transient ischaemic attack, the 2021 European Stroke Organisation guidelines on carotid endarterectomy

Smartphone video may offer noninvasive stroke screening option

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Motion analysis of video recorded on a smartphone accurately detected narrowed carotid arteries, according to new research published in the Journal of the American Heart Association.

“BETWEEN 2% AND 5% OF STROKES each year occur in people with no symptoms, so better and earlier detection of stroke risk is needed,” said lead study author Hsien-Li Kao (National Taiwan University Hospital, Taipei, Taiwan).

“This was an exciting ‘eureka’ moment for us,” Kao said. “Existing diagnostic methods—ultrasound, computed tomography and magnetic resonance imaging—require screening with specialised medical imaging equipment and personnel. Analysis of video recorded on a smartphone is non-invasive and easy to perform, so it may provide an opportunity to increase screening. Though more research and development are needed, the recordings and motion analysis may be able to be implemented remotely, or a downloadable app may even be feasible.”

This study, conducted between 2016 and 2019, used motion magnification and pixel analysis to detect the minute changes in pulse characteristics on the skin’s surface captured in a smartphone video recording.

A group of 202 Taiwanese adults (average age of 68 years; roughly 79% men) who received care at a single Taiwanese hospital participated in the study. Among the participants, 54% had significant carotid artery stenosis, meaning they had at least 50% blockage that was previously diagnosed by ultrasound, while 46% did not have significant stenosis. Recordings were captured with participants laying on their back, with their head tilted back in a custom-made box that minimised outside movement.

An Apple iPhone 6, 64GB, was mounted to the box to capture a 30-second video recording of the person’s

(CEA) and carotid artery stenting (CAS), the 2021 German-Austrian guidelines on the management of carotid disease, and the 2021 Society for Vascular Surgery guidelines on the management of patients with carotid and vertebral artery disease.

In addition, the authors note that a series of unanswered questions in the 2017 guidelines were highlighted as being priorities for future research. “These involved scenarios where there were either no data, or conflicting evidence that did not allow recommendations to be made,” they elaborate. The current guidelines have addressed some of these questions, which include: Is there a validated algorithm for identifying ‘higher risk for stroke’ ACS [asymptomatic carotid stenosis] patients? Does ACS cause cognitive decline and can this be reversed or prevented by CEA or CAS? And which recently symptomatic patients with <50% stenosis might benefit from urgent CEA or CAS?

neck. The older generation phone was used as researchers believed it would be more common to the average user, Kao explained.

Researchers found that the video motion analysis algorithm had an 87% accuracy rate of detecting stenosis in the group known to have carotid artery stenosis. All study participants also had standard Doppler ultrasound testing to confirm narrowing in their arteries and to gauge and validate the estimates from the video motion analysis.

“More research is needed to determine whether video recorded on smartphones is a promising approach to help expedite and increase stroke screening,” Kao said. “Carotid artery stenosis is silent until a stroke happens. With this method, clinicians may be able to record a video of the patient’s neck with a smartphone, upload the videos for analysis and receive a report within five minutes. The early detection of carotid artery stenosis may improve patient outcomes.”

There were several limitations to the study including the small number of study participants, all of whom were considered at high risk for a cardiovascular event. In addition, neck length and neck angle were not analysed, which may affect the results of the video analysis. Skin colour is not likely to hinder applications to a broader population since a standard lighting method was used for this assessment, according to Kao. The study was funded by the Ministry of Science and Technology in Taiwan.

Though more research and development are needed, the recordings and motion analysis may be able to be implemented remotely, or a downloadable app may even be feasible.”

September 2022 | Issue 95

16 Advertorial THIS ADVERTORIAL IS SPONSORED BY BENTLEY

Bentley provides complete vascular solution with comprehensive covered stent portfolio The range and complexity of vascular pathologies that interventionalists face necessitates a complete and comprehensive solution. Bentley, with its coronary, peripheral and aortic iterations (ranging from 2.5 to 30mm) of the BeGraft balloonexpandable covered stent, claims to offer such a solution. In this interview with Vascular News, two interventional radiologists give weight to this claim, sharing their clinical experience and opinions on the BeGraft covered stent portfolio.

M

ohamad Hamady, senior consultant vascular interventional radiologist and professor of practice in image-guided surgery and interventional radiology at Imperial College London (London, UK), states that covered balloon-expandable stents play an important role in his practice. He underlines an unmatched range of features for a wide range of patients and pathologies that make the BeGraft family “the first thing we look for” when choosing equipment for a case. Christoph Binkert, chair of radiology and nuclear medicine and head of interventional radiology at Kantonsspital Winterthur (Winterthur, Switzerland) concurs, citing in particular his extensive experience with the BeGraft aortic, which he describes as a “lifesaver” that “needs to be on the shelf of every interventional radiologist”.

What role do covered balloonexpandable stents play in your department?

MH: Covered balloon-expandable stents play a pivotal role in our department because they are suitable for treating a range of pathologies, from aneurysmal disease to occlusive disease. With these pathologies, we need a stent that is safe to deliver, durable, and enables technical success. In many instances and in

many pathologies, in fact, it seems covered balloonexpandable stents are increasingly used because they give superior results to bare metal stents.

CB: In our department, covered balloon-expandable stents also play a central role. We use these devices mainly for fenestrated stent grafts or there is irregular, odd-looking plaque. Finally, yet importantly, if there is a rupture during an intervention, it is good to know that you can place a covered balloon-expandable stent to resolve a potentially dangerous problem.

Why do you need covered balloonexpandable stents that range from 2.5 to 30mm in diameter for your procedures?

MH: It is important that covered balloon-expandable stents are available in a range of diameters because this increases the number of patients and pathologies we are able to treat, in elective and emergent settings. For example, we need small diameter stents in certain cases where the native vessel, which carries the aneurysm, is of a small diameter. Instead of sacrificing that artery or branch, the smaller diameter stent gives us the ability to navigate through those small vessels. Take an aneurysm in the hepatic or splenic artery, for instance, the small diameter stents from the Bentley family offer a low profile, good crossability, and flexibility, reasonable adherence of the stent to balloon as well as smooth conformability to the vessel anatomy.

CB: Furthermore, you want these stents to fit more or less exactly to the size of the vessel. If you have too small of a stent, it will not attach and the blood will flow around it, which will be a nightmare, but if you oversize it too much then you risk damaging the vessel.

Therefore, it is very important you have a good size matrix. Typically, I tend to slightly oversize, but not by much.

stents needed a much larger sheath and that was a big disadvantage, because sometimes when you are in a difficult situation you have to be able to get the stent in, ideally without changing the sheath. This is something Bentley worked on and the small profile is now a key feature of the BeGraft family.

Can you give an example of a case involving the BeGraft Coronary?

MH: I remember a case in which the combination of small diameter, low profile, flexibility and good crossability that the BeGraft coronary offers enabled me to treat a tiny vessel. This case involved a hepatic artery aneurysm, which was a fusiform aneurysm and so involved the entire length of that aneurysmal segment. In addition, it was in a small diameter vessel, around 3.8mm, and so it was difficult to use other covered stents. I could not treat the aneurysm unless I embolised and sacrificed all vessels, which is not something I wanted to do. The BeGraft coronary enabled me to treat that vessel successfully.

Can you give an example of a case involving the BeGraft aortic?

MH: The BeGraft aortic comes in various lengths and diameters, and can go up to quite large diameters of around 30mm, and for these reasons I have used it several times, both in aneurysmal and occlusive disease. A particular case that comes to mind involves occlusive disease. The aorta and both iliac arteries needed stenting, and there was a good discrepancy between the normal segment and the diseased segment, with a short involvement of the distal aorta. Because the BeGraft aortic comes with a large diameter but still provides the option of choosing a short length, I was able to use the BeGraft aortic and kissing BeGrafts to perform the Covered Endovascular Reconstruction of Aortic Bifurcation (CERAB) technique, without having to cover a longer segment of the aorta that you do not really need to treat.

CB: The BeGraft aortic is sometimes a lifesaver. I believe this product needs to be on the shelf of every interventional radiologist, especially when you work in the aorta, or in the large iliac, because the vessel diameters are sometimes so large that you require stent diameters only offered by the BeGraft aortic. Also with

Do the BeGraft products differ from other covered balloon-expandable stents on the market and if so, how?

Covered balloonexpandable stents play a pivotal role in our department because they are suitable for treating a range of pathologies.”— Mohamad Hamady

MH: The BeGraft products have a number of unique features. They are available in a wide range of lengths and diameters and have two shaft lenghts so they can be used via either the femoral or the antegrade approach. Depending on single or double ePTFE layers and integrated scaffolding, the stent can give higher or standard radial force. They have a lower profile than their competitors do, and this is an important feature, especially when we are talking about using a radial or brachial approach. In general, if we can achieve a task with a smaller sheath, this is an advantage because it makes the procedure less invasive. We know that when the procedure becomes less invasive, it is quicker, carries fewer complications, and is likely more successful.

CB: I would like to mention again the small profile compared to other stents. Older versions of covered

The BeGraft aortic is sometimes a lifesaver. I believe this product needs to be on the shelf of every interventional radiologist.”— Christoph Binkert

Issue 95 | September 2022

Advertorial 17

rupture, it is great to have a BeGraft aortic on hand. In fact, there does not even need to be a Frank rupture, even if you just see a very bad irregularity or a bad dissection the BeGraft aortic is useful here. I remember a tough case, which was a nearly circular calcification of the aorta. I was a little hesitant to treat this patient, but everyone including the patient wanted me to go ahead. Sure enough after angioplasty there was not a Frank rupture, but there was contrast outside the lumen. With the help of an aortic BeGraft a good result could be achieved.

How important is it for you to work with smallest possible sheath compatibilities, and what role does the BeGraft peripheral play in this?

in a sometimes-tortuous artery, such as a splenic or hepatic artery, then you are not able to get there.

In addition, the small sheath is not a matter of just comfort, it is actually a matter of being able to do the case or not. Especially in the visceral arena, it is important to have a 6Fr available, but not more than that, to get to the place where you want to place the stent.

As interventional radiologists, you are familiar with handling different types of catheters, sheaths and stent systems.

Could you summarise the key features of the Bentley BeGraft portfolio?

CB: The small sheaths are very important. If I am using the BeGraft for a visceral aneurysm, for example, and you have to place more than a 6Fr sheath

CB: The BeGraft product family covers all areas and the technology allows physicians to use relatively small delivery systems. This helps us to get to the point where we want to be, and, in emergency cases, we do not have to change the sheath, which is very important.

Figure 1: Computed tomography angiography demonstrated a voluminous pseudoaneurysm of the hepatic artery following duodenopancreatectomy.

Figure 2: Preliminary angiography performed through a 4Fr 90cm sheath from a left brachial artery access confirmed the lesion.

The BeGraft products also have good trackability, and so they travel nicely. This is another new feature, in fact. The old stents were slightly bulky, and so a lot of the time you were not able to get to the point of deployment. This is something else that Bentley addressed and now the stents’ trackability is a key feature.

MH: The main features of the BeGraft product family are radiological visibility, flexibility, crossability, the lowest profile on the market, a wide range of lengths and diameters, good flaring, and minimal foreshortening. In addition, they have a very good radial force, and this is especially important when we use the branched aortic stent grafts to avoid a kink or compression of the artery such as we see sometimes in the coeliac trunk or renal branch with unfavourable take-off angle. These features make the BeGraft family the first thing we look for when we are choosing equipment for a case.

Figure 3: Completion angiography after the implant of two overlapped BeGraft Coronary 4x18mm stent graft showed the complete sealing of the pseudoaneurysm.

Courtesy of Maria Antonella Ruffino, Interventional Radiology Department, EOC Lugano, Lugano, Switzerland

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Indications: The IMPEDE Embolization Plug, the IMPEDE-FX Embolization Plug, and IMPEDE-FX RapidFill are indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature. The TrelliX Embolic Coil System is intended to obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. Indications include intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and arterial and venous embolizations in the peripheral vasculature. Refer to the IFU – supplied with each device – for a complete statement of the indications, contraindications, warnings, and instructions for use.

Inferior Mesenteric (IMA) and Renal Accessory Artery angiographic image courtesy of Alexander Maβmann, MD, Saarland University Medical Center, Homburg/Saar, Germany. The images are illustrative and do not represent the actual size of any products.

Patent: www.shapemem.com/patents Shape Memory Medical products and associated components are not available in all countries or regions. Please contact your Shape Memory Medical representative for details regarding product availability.

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Issue 95 | September 2022

Surgery Alternatives 19

CAROTID

Research indicates low stroke risk and benefit of medication alone in asymptomatic carotid stenosis The risk of having a future stroke caused by asymptomatic carotid stenosis is “so low” that most patients with this condition could potentially be treated with the newest medications and may not require surgery. That is according to new research from Kaiser Permanente.

“T

he question of how to best treat patients with narrowing of the carotid artery without symptoms has been a longstanding research priority,” said Robert Chang (The Permanente Medical Group, Oakland, USA). “We decided to take a step back and begin our study by asking how likely it is that these patients will actually have a stroke related to their severe stenosis.

Our analyses showed that this risk is so low that it appears that, for most patients, surgery may not be necessary.”

The study, published in The Journal of the American Medical Association (JAMA), is believed to be the largest and most current assessment of longterm stroke risk in this population, according to Kaiser Permanente.

Carotid stenosis occurs when plaque builds up in one or both of the large arteries on either side of the neck that

carry blood to the brain, face, and head. This narrowing in the artery is typically diagnosed after a patient has experienced symptoms of a stroke, but it can also be found during a routine physical examination.

Randomised clinical trials conducted prior to 2010 concluded that surgery to remove the blockage was the best option for reducing stroke risk in patients with severe stenosis. But, as medical treatments for reducing stroke risk have improved, physicians have begun to wonder whether surgery should remain the preferred treatment for asymptomatic patients, a Kaiser Permanente press release states.

To answer that question, Chang and his colleagues identified 3,737 Kaiser Permanente members in Northern California who had been diagnosed with severe asymptomatic carotid stenosis (70–99% blockage) between

JACC study makes case for expanding coverage for carotid artery stenting Research from Ochsner Health (New Orleans, USA) published in the Journal of the American College of Cardiology (JACC) is likely to influence expanded insurance coverage for carotid artery stenting.

THE PAPER, “CAROTID ARTERY stenting: JACC state-of-the art review”, details significant advances in the field of carotid stenting.

It concludes that the technique “has achieved parity with carotid surgery for stroke prevention,” and that the data “support updating the national coverage decision for carotid stenting from the Centers for Medicare and Medicaid Services [CMS] to equal coverage for carotid surgery”.

“Carotid artery stenting is a minimally invasive procedure compared to open surgery,” explains first author Christopher White (John Ochsner Heart & Vascular Institute, New Orleans, USA). “Overall, stenting and surgery are equivalent in patients who are good candidates for both, and the patient and

2008 and 2012. None of these patients had previously had surgery.

The research team first looked to see how the stenosis had been treated.

Reviewing the patients’ medical records showed that 1,423 patients had had surgery to treat the stenosis, and 2,314 had not. The team also tracked which patients were taking a statin to help lower cholesterol in the blood or medication to reduce high blood pressure. Next, the team looked to see how many patients had a carotid-related stroke on the same side as the severe carotid stenosis. They followed the patients through 2019.

Overall, 133 strokes were diagnosed in 129 patients during the follow-up period. Statistical analyses showed that the patients who did not have surgery had a 4.7% cumulative risk of having a stroke within five years of their carotid stenosis diagnosis.

The study’s senior author, Mai Nguyen-Huynh (The Permanente Medical Group, Oakland, USA), said the findings did not surprise her. “We suspected that we may find a low risk

of stroke in these patients because there are now better stroke-prevention treatments, including medications to control blood pressure, prevent blood clots, and reduce cholesterol, than when the original randomised trials were done,” she said. “I think our study will make many patients and their doctors think twice about surgery if they can instead be on an effective, aggressive medical management programme to lower their stroke risk from asymptomatic carotid disease.”

Chang and Nguyen-Huynh also currently lead a team at the Kaiser Permanente Division of Research affiliated with a national, randomised clinical trial, called CREST-2, that is enrolling patients in a study comparing surgery or stenting to medical management in patients with asymptomatic severe carotid stenosis.

“This head-to-head comparison of carotid surgery versus medical management in a clinical trial is what we need to help us determine the appropriate approach,” Nguyen-Huynh added.

I think our study will make many patients and their doctors think twice about surgery if they can instead be on an effective, aggressive medical management programme to lower their stroke risk from asymptomatic carotid disease.”

Mai Nguyen-Huynh

their doctor should discuss which one is better for likely to be expanded in the near future to include the individual patient.” coverage for carotid stenting that is equal to carotid The paper analyses several large, multicentre surgery for those who are symptomatic with a randomised controlled trials encompassing data carotid stenosis ≥50% and ≤99%, and those who are from over 25 years and more than 10,000 patients asymptomatic patients with carotid stenosis ≥70% to demonstrate that carotid artery stenting can be and ≤99%. just as effective as surgery when it comes to long“We believe our multidisciplinary paper, written term stroke prevention and durability. by neurologists, neurosurgeons, vascular surgeons, The paper suggests that the current CMS coverage and cardiologists, will be an important summary of decision regarding carotid stenting is outdated the most recent evidence that will support CMS in and places Medicare patients at a disadvantage by reimbursing both procedures on an equal basis,” restricting their options for less invasive treatment, says White. and recommends expanding coverage to be equivalent to open surgery.

The paper “The current literature encompasses data supports equivalent results for carotid stenting from over and carotid surgery in patients who are suitable candidates for both procedures,” says White.

“Some patients will not be good candidates for stenting and should receive surgery, while some patients will be poor and candidates for surgery and should receive stents.”

Current coverage is

25 years

more than 10,000 patients

September 2022 | Issue 95

20 Interview

PROFILE

Joseph S Coselli

Joseph S Coselli (Baylor College of Medicine, Houston, USA) speaks to Vascular News about his career to date. Despite initially planning to follow in his family’s footsteps and attend law school, a summer internship at the Texas Heart Institute in Coselli’s native Houston changed the course of his career forever. The internship sparked an interest in cardiovascular surgery that would culminate in his current roles as professor of Surgery and executive vice chair of the Michael E DeBakey Department of Surgery at Houston’s Baylor College of Medicine, among others. Coselli has received widespread recognition for his work in cardiovascular and aortic surgery, and credits his success in large part to the important role of three celebrated mentors—Michael E DeBakey, Denton A Cooley and E Stanley Crawford.

I did not take the conventional route to medicine and cardiothoracic surgery. In my first year of college, I planned to become an attorney and attend law school, as practically everyone in my family had done.

Between my first and second years of college, I needed a summer job. I met Dr Denton A Cooley, who offered me an internship as a college student at the Texas Heart Institute, here in Houston’s Texas Medical Center.

Except for my family doctor, I knew no other doctors.

That summer, I witnessed pioneering and dramatic cardiovascular surgery on an epic scale. Following this experience, I made the decision that I would become a cardiothoracic surgeon and, and I have never looked back.

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

My mentors were giants and trailblazing experts in cardiovascular and aortic surgery: Dr Denton A Cooley, Dr Michael E DeBakey, and Dr E Stanley Crawford. Dr Cooley (who is also a native Houstonian like myself) was my first mentor, giving me a summer internship as a college student at the Texas Heart Institute. His advice was to “be the first one in and the last one out,” or to work harder than the person next to you. Dr DeBakey, my next mentor, was the programme director for my general surgery, vascular surgery, and cardiothoracic surgery programmes. His advice was to pursue excellence in every effort and goal in life.

Dr E Stanley Crawford, a pioneering aortic surgeon, a southern gentleman from Alabama, and the godfather of the thoracoabdominal aortic aneurysm, was my third mentor. His advice was to treat every patient compassionately and as an individual. Additionally, he instilled in me the concept of keeping track of all my cases and data, reviewing them regularly, and learning from them in order to improve and teach.

What has been the most important development in cardiothoracic surgery during your career so far?

The development of numerous minimally invasive and endovascular procedures has been the most significant advancement in cardiothoracic surgery during my career thus far. Abdominal endovascular aneurysm repair (EVAR), descending thoracic endovascular aortic repair (TEVAR), replacement of the aortic valve with a transcatheter aortic valve (TAVR), and most recently, hybrid open and endovascular aortic devices such as Thoraflex from Terumo Aortic.

What has been the biggest disappointment? Something you hoped would change practice but did not?

I have not had any major disappointments, but in the 1980s we pursued the use of laser therapy to open occluded arteries (such as the iliac, superficial femoral, and tibial arteries, among others). It did not evolve into the spectacular development that we had hoped for at the time. Although more recently, similar advancements have been made in opening medium and small vessels.

How do you anticipate the field might change in the next decade, and what development would you most like to see realised?

I believe that minimally invasive and endovascular therapies will continue to evolve and advance.

Although the descending thoracic and abdominal aorta have been well established for endovascular therapy, similar therapies to treat the thoracoabdominal, ascending, and arch are still under development. I suspect that over the next decade, technology will solve the issues these specific areas present, including the development of an endo Bentall, in which the aortic valve and aortic root are endovascularly replaced.

What are the biggest challenges currently facing cardiothoracic surgery?

Cardiothoracic surgery has several substantial challenges. First, there is an educational challenge. The complexity of cardiac surgery is increasing, as has its pool of related information. Simply put, the fountain

I believe that minimally invasive and endovascular therapies will continue to evolve and advance.”

of knowledge has exploded. Organising this into an educational format to prepare future cardiothoracic surgeons remains a daunting task. Cardiovascular research has been underfunded, for many decades.

There is no question that there are enormous needs in the area of research. Clinically, cardiothoracic surgery is becoming increasingly challenging due to extensive pathology such as infection (i.e. endocarditis), advanced age (i.e. our population is ageing), and increasing patient morbidities. Particularly from a standpoint of minimally invasive approaches, partnership with industry will be necessary to address these concerns.

What are your current areas of research?

Our present research interests include the continued development of cardiovascular devices including aortic valves, particularly TAVR, endovascular therapy for aortic surgery, and evolutionary improvements

alisonlang.com

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

in mitigating the risk of thoracoabdominal aortic aneurysm repair. In the laboratory, we are studying the influence of fluoroquinolones on the development of aortic pathology in mice.

Recently, I was co-author of an important paper titled “Staged repair of extensive aneurysms of the thoracic aorta by using the elephant trunk technique,” published in The Annals of Thoracic Surgery 2022.

This study evaluating 363 staged elephant trunk repairs followed by 203 second-stage elephant trunk repairs concluded that treating extensive aortic aneurysms by using the elephant trunk technique is associated with notable morbidity and mortality; however, this is driven in some part by those who present with acute systems, who are the ones with a greater risk of developing postoperative adverse events. This paper is particularly useful as it serves as a benchmark of traditional open elephant trunk repair, which is being replaced in many centers with the frozen elephant trunk approach.

Issue 95 | September 2022

Interview 21

You have a number of professional society presidencies to your name.

Could you list some of the highlights of these roles?

I have served as president of the Texas Surgical Society and the Southern Thoracic Surgical Association, which are fantastic organisations. Regarding the Cooley and DeBakey societies, it was an incredible honour to be the only individual to serve as president of the Denton A Cooley Cardiovascular Surgical Society and the Michael E DeBakey International Surgical Society.

However, the most significant position I have ever held was being president of the American Association for Thoracic Surgery, which is the oldest and most prestigious organisation of its type worldwide.

What has been your most memorable case?

I have decades’ worth of memorable cases. However, I would have to say the top two most interesting were, 1) an open cholecystectomy of a severely inflamed gallbladder on a woman who later became my mother-in-law, and 2) I removed a lung tumor from one of my mentors, Jimmy Frank Howell, a renowned cardiovascular surgeon in his own right, and he lived an additional nine years after having the procedure.

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

First and foremost, study hard, work hard, and keep an open mind. Medicine is a discipline that is continuously evolving. One should never be dogmatic about any particular issue and equally important, one should always maintain a healthy work/life balance.

What are your hobbies and interests outside of medicine?

Golf and reading are my two most important hobbies outside of medicine. Although I am not particularly good at golf, it offers an opportunity to be outside for an extended amount of time, and the collegiality and social aspects are quite enjoyable. The other is reading.

I read everything from history, and novels, to current events. I have always believed that instilling a love for reading in your children, then their quality of life will be immensely enhanced.

Current academic appointments:

Executive vice chair, Michael E DeBakey Department of Surgery, Baylor College of Medicine, Houston, USA Professor of Surgery, Division of Cardiothoracic Surgery, Baylor College of Medicine Director, Aortic Fellowship Program, Baylor College of Medicine Director, Thoracic Surgery Residency Program, Texas Heart Institute and Baylor College of Medicine

Current clinical appointments:

Associate chief, Cardiovascular Service, Baylor St Luke’s Medical Center, Houston, USA Surgeon, Adult Cardiac Surgery, Texas Institute, Houston, USA

Society presidencies (selected):

2015: American Association for Thoracic Surgery 2010–2011: Southern Thoracic Surgical Association 2008–2010: Michael E DeBakey

International Surgical Society

Education (selected):

1982–1984: Residency in Thoracic Surgery, Baylor College of Medicine 1977–1982: Residency in General Surgery, Baylor College of Medicine 1974–1977: University of Texas Medical Branch at Galveston, Galveston, USA 1971–1974: University of Notre Dame, South Bend, USA

September 2022 | Issue 95

22 Exercise Therapy

“No pain, no gain” approach improves walking ability with peripheral arterial disease Walking for exercise at a pace that induced pain or discomfort improved walking ability among people with peripheral arterial disease (PAD), according to new research published in the Journal of the American Heart Association (JAHA).

THIS STUDY EXAMINED THE EFFECTS OF home-based walking for exercise among 264 people with PAD who were participating in a randomised clinical trial, called the Low-Intensity Exercise Intervention in PAD (LITE), which included 305 people overall.

From September 2015 to December 2019, participants enrolled in the LITE study at four US medical centres (Northwestern University, Tulane University, University of Minnesota and University of Pittsburgh). Their average age was 69 years, 48% were women and 61% were Black adults.

Researchers randomly assigned participants to one of three groups for 12 months. The first group (38%) walked at home at a comfortable pace; the second group (41%) walked at home at a pace that induced leg symptoms; while the third group (21%) did not walk for exercise. Both walking exercise groups wore an ActiGraph, a device that monitored the intensity of their walking and the time walked.

Personalised thresholds for the ActiGraph intensity that corresponded to walking for exercise at a pace that induced leg symptoms (high intensity) and that corresponded to walking for exercise at a comfortable pace without leg symptoms (low intensity) were defined for each individual randomised to an exercise intervention. Participants randomised to exercise wore their ActiGraph device during walking exercise activity and uploaded data on exercise frequency, intensity and duration to the study website.

At the study’s start, and at six and 12 months, participants completed three tests of leg function: walking speed over a four-metre distance (13 feet) at

usual pace, walking speed over a four-metre distance at fastest pace and the short physical performance battery (SPPB) consisting of four-metre walking velocity at usual pace, a standing balance test and the time for five repeated chair rises.

At six months, participants whose walking pace induced leg pain or discomfort walked 11 feet per minute faster, and at 12 months, they walked more than 16 feet per minute faster than participants whose walking pace did not induce leg pain or discomfort.

Compared to non-exercisers, participants in the group that walked for exercise at a pace inducing leg pain or discomfort walked nearly 13 feet per minute faster at six months, however, this increase was not statistically significant at 12 months.

At 12 months, people who walked for exercise with leg pain or discomfort scored almost one point higher on the At 12 months, participants sum of the three leg function tests whose walking pace (the short physical induced leg pain or performance discomfort walked 16 feet battery), out per minute faster than of a total of 13 participants whose walking points (0–12), pace did not induce leg pain compared to people or discomfort who walked at a comfortable pace with no leg pain. For those walking for exercise at a comfortable pace, there was no improvement in walking speed at six months or 12 months compared to non-exercisers.

Study demonstrates feasibility, effectiveness of at-home exercise therapy plus cognitive behaviour therapy for intermittent claudication A MOBILE PHONEadministered, home-based exercise therapy programme for patients with intermittent claudication (IC) incorporating cognitive behaviour therapy (CBT) was found to be feasible, with 78% of participants completing the whole course, this year’s Society for Vascular Surgery (SVS) Vascular Annual Meeting (VAM 2022; 15–18 June, Boston, USA) heard. The findings were part of a study delivered by Oliver Aalami (Stanford University School of Medicine, Stanford, USA).

Aalami reported having chosen patients whose peripheral arterial disease (PAD) had been confirmed by abnormal ankle-brachial or toebrachial index, or who had IC. The programme they participated in was 12 weeks of home-based, mobile

phone-delivered, exercise therapy, Aalami elaborated. Participants were tasked with performing phone-based, six-minute walk tests and completing mini-WIQ QOL [Walking Impairment Questionnaire and Quality of Life] surveys. They were also asked to complete three health education courses (What is peripheral arterial disease?; Exercise; and Nutrition) and were asked to record at least three 30-minute exercise therapy walks a week using their personal mobile phones.

Participants also received daily “doses” of health education via text message.

Alongside this, participants had regular weekly check-ins with health coaches trained in CBT techniques such as motivational interviewing.

They also spoke with a health coach at the beginning, middle and end of the programme to discuss their progress.

“We were surprised by the results because walking for exercise at a pace that induces pain in the legs among people with PAD has been thought to be associated with damage to leg muscles,” said senior study author Mary M McDermott (Northwestern University’s Feinberg School of Medicine, Chicago, USA). “Based on these results, clinicians should advise patients to walk for exercise at a pace that induces leg discomfort, instead of at a comfortable pace without pain.”

This underscores the benefits of walking for exercise at a pace that induces leg pain or discomfort.

“This finding is consistent with ‘no pain, no gain’ with regard to walking exercise in PAD,” McDermott said.

“Exercise that induces leg pain is beneficial, though difficult,” McDermott said. “We now are working to identify interventions that can make the higher intensity exercise easier—and still beneficial—for people with PAD.” It is important to note that study participants walked at home, so the results may not apply to walking on a treadmill in the presence of a health professional, which is the standard of care and first-line therapy according to clinical practice guidelines. In addition, the outcomes in this report were not prespecified outcomes for this clinical trial.

Therefore, these findings must be confirmed in future research.

In May 2022, the American Heart Association and 24 collaborating organisations launched the PAD National Action Plan, a guide to assist in the prevention of PAD complications, treatment of cardiovascular risk and improvement of quality of life for those living with the disease.

Aalami stated that his reasoning for wanting to include CBT techniques in the programme was that it is linked to immediate and lasting behaviour change.

Of the 145 patients (40% women; mean age=65) onboarded across 18 institutions (of which 44% did not offer in-person exercise therapy), 78% of patients completed the programme, Aalami told VAM delegates. In total, patients recorded having spent 149,135 minutes walking 5,205,943 steps as part of the exercise therapy programme.

Aalami added that 19 of those initially enrolled paused, withdrew or were non-responsive due to medical issues, technical difficulties or privacy

Regarding freedom from intervention, at six months, the figure was 92%, and at 12 months, 69%.”

concerns. Ninety-two percent of patients achieved the CBT S.M.A.R.T goals (specific; measurable; achievable; realistic; timely) they had set prior to beginning the programme, Aalami then acknowledged.

Regarding freedom from intervention, at six months, the figure was 92%, and at 12 months, 69%.

This, Aalami told Vascular News, is promising, as it goes some way to mirroring the five-year results observed in an in-person supervised exercise therapy study in The Netherlands.

He also spoke to the challenges of implementing exercise therapy for IC and PAD patients in the USA. Among the obstacles, he cited poor programme availability, the requirement for patients to travel to a facility for inperson therapy, and the low rate of reimbursement.

Aalami concluded that “accessible and lower-cost digital health approaches to exercise therapy for patients with PAD and intermittent claudication could play a role in addressing the wide supervised exercise therapy utilisation gap faced today.”

Image courtesy of the American Heart Association

PERIPHERAL

Issue 95 | September 2022

Disparities 23

PERIPHERAL

Researchers report higher three-year amputation and reintervention rates in Black and Hispanic CLTI patients IN A STUDY OF OVER 7,000 chronic limb-threatening ischaemia (CLTI) patients, researchers found that Black and Hispanic patients had higher three-year amputation and reintervention rates; survival, however, was higher among Black patients and similar between Hispanic and White patients. Aderike Anjorin (Duke University Medical Center, Durham, USA) delivered these findings at this year’s Society for Vascular Surgery (SVS) Vascular Annual Meeting (VAM 2022; 15–18 June, Boston, USA).

Framing the research, Anjorin stated that Black and Hispanic patients have higher rates of CLTI and suffer worse outcomes after lower extremity bypass compared with White patients. The underlying reasons for these disparities are unclear, she said, specifying that data on long-term outcomes are limited. In order to address this gap in the literature, Anjorin and colleagues examined differences in three-year outcomes after open infrainguinal revascularisation for CLTI by race/ ethnicity and explored potential factors contributing to these differences.

The research team identified all CLTI patients undergoing primary open infrainguinal revascularisation in the Vascular Quality Initiative (VQI) registry from 2003–2017 with linkage

(20% vs. 19%; HR: 0.9 [0.4–2]), reintervention (55% vs. 57%; HR: 0.8 [0.5–1.2]), or survival (64% vs. 58%; HR: 1.2 [0.8–1.9]) in this group.

In adjusted analyses, the speaker communicated, the Aderike to Medicare through 2018 association of Black and Hispanic Anjorin for long-term outcomes, the race with amputation and presenter detailed. She communicated reintervention was explained primarily that primary outcomes were threeby differences in demographic year amputation, reintervention, and characteristics (age, sex) and baseline survival, and that secondary outcomes comorbidities (tobacco use, diabetes, were factors associated with disparate renal disease). outcomes.

Anjorin concluded that disparities Anjorin informed the VAM audience in amputation and reintervention that a total of 7,108 CLTI patients were rates are partly attributable to included in the study. Of these patients, demographic characteristics and the she specified, 5,599 (79%) were nonhigher prevalence of comorbidities Hispanic White, 1,053 (15%) were in Black and Hispanic patients with Black, 48 (1%) were Asian, and 408 CLTI. “Interventions to improve early (6%) were Hispanic. diagnosis, risk factor modification, Presenting the study findings, and postoperative surveillance in these Anjorin reported that Black patients populations may confer long-term had higher rates of three-year limb salvage benefits,” the speaker told amputation (32% vs. 19%; hazard ratio VAM attendees.

[HR]: 1.9 [95% confidence interval: “Is ethnicity simply a marker for 1.7–2.2]), reintervention (61% vs. 57%; socioeconomic status, and is that HR: 1.2 [1.1–1.3]), and survival (62% driving these outcomes?” was the first vs. 58%; HR: 1.1 [1.01–1.2]) compared question in the discussion following with White patients. Hispanic patients, Anjorin’s presentation. “It is very likely the speaker added, experienced higher that socioeconomic status plays a role,” rates of amputation (27% vs. 19%; HR: the speaker responded. However, she 1.6 [1.3–2]) and reintervention (70% stressed that the data used in the team’s vs. 57%; HR 1.4 [1.2–1.6]) compared study make it hard to establish exactly with White patients; however, survival how big a role it plays, in part because was similar between the groups (62% all patients that have been included vs. 58%; HR: 1.1 [0.98–1.3]). are insured, and therefore likely do not In addition, Anjorin relayed that the represent the entire CLTI population. low number of Asian patients prevented Expanding on this point in response meaningful assessment of amputation to another question, Anjorin remarked

Revascularisation strategy for BTK intervention should hinge on diagnostic modality, LINC audience hears New data provide “another argument” for the use of intravascular ultrasound (IVUS) in below-the-knee (BTK) interventions. This is according to Michael Lichtenberg (Arnsberg Vascular Center, Arnsberg, Germany), who presented one-year outcomes from the PRESTIGE pilot study at the Leipzig Interventional Course (LINC) 2022 (6–9 June, Leipzig, Germany).

T

his study was designed to investigate whether an IVUS-guided lesion preparation strategy with the Phoenix atherectomy system (Philips) before drug-coated balloon (DCB) angioplasty can improve outcomes in chronic limbthreatening ischaemia (CLTI) patients. The results led Lichtenberg to conclude that the revascularisation strategy for below-the-knee (BTK) intervention should be based on diagnostic modality to achieve optimal lumen gain.

How can enough and stable lumen be achieved?

This is a central question in daily interventional practice, according to the presenter. In order to address this issue, Lichtenberg and colleagues initiated the core-lab adjudicated, prospective, single-arm PRESTIGE pilot study, which is being carried out across five centres in Germany.

The primary efficacy endpoint is patency at six

months, and the primary safety endpoint is freedom from major adverse limb events and/or 30-day perioperative death.

A total of 50 patients have been enrolled in the study, Lichtenberg detailed. Because this is a CLTI study, the presenter stressed that the patients presented with high-risk profiles and significant comorbidities. “A lot of these patients had renal insufficiency, and a lot had diabetes,” he noted.

Lichtenberg pointed out that the challenging nature of the patients included in this study was also apparent in their clinical symptoms, highlighting that the majority (35/50) were Rutherford 5 and that the mean preprocedure Wound, Ischemia, foot Infection (WIfI) score was 3.25. Additionally, of the 96 lesions treated in the registry, most were longer than 20cm.

that there are other factors at play in the differing outcomes. She emphasised the importance of considering social determinants of health, such as health literacy and geographic location affecting access to centres for exercise therapy, for example. “Unfortunately, we do not have these variables in the current dataset,” she said.

SVS president and session moderator Ali AbuRahma (West Virginia University, Charleston, USA) was keen to get Anjorin’s take on whether CLTI patients were visiting a physician too late and therefore presenting with a disease too advanced for treatment.

The speaker replied: “We did look at urgency status, and in our adjusted analysis this did not really play a huge role for amputation or reintervention, so it really was the higher burden of comorbidities that drove these differences.”

In another question from the audience, a delegate asked whether the presenter could comment on racial disparities as they pertain to the decision to undergo primary amputation, i.e. those who have an upfront decision to undergo primary amputation as opposed to revascularization and then amputation.

Given that the research team used VQI data, Anjorin responded that they do not have the data on individual patient decision-making.

Anjorin performed the analysis and delivered the VAM presentation under the guidance of senior author Marc L Schermerhorn (Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, USA).

Reporting 12-month results of the PRESTIGE pilot study in a first time data release presentation at LINC, Lichtenberg first revealed outcomes of the technical success analysis. The combination therapy of IVUS-guided lesion preparation followed by DCB angioplasty brought the diameter stenosis down from 93% to 26.02% based on angiography analysis, he relayed.

In addition, the presenter revealed that the overall survival rate was 85.9% after one year and that the major amputation-free survival rate was 100%.

The figure for target-lesion-revascularisation-free survival, he added, was 88.8% after one year.

In terms of the efficacy analysis, Lichtenberg conveyed that there was a “very good clinical outcome” in terms of the WIfI score, which came down from baseline to six months and stayed at a low level out to 12 months. In addition, the Rutherford scale showed a “clinically favourable outcome” for this combination therapy, he informed attendees.

A notable finding of the study, according to Lichtenberg, was that the baseline reference vessel diameter based on angiography was lower than that based on IVUS. “We significantly underestimate [vessel] diameter on angiography in patients with CLTI,” he informed LINC attendees, stressing that “there is a need to find an appropriate diagnostic modality for correct vessel sizing”.

Michael Lichtenberg

September 2022 | Issue 95

24 Compression Therapy

VENOUS

Compression duration affects pain during superficial venous intervention, study finds Postprocedural compression of one to two weeks after superficial venous incompetence (SVI) treatment is associated with reduced pain compared with a shorter duration. This is according to a study published in the August edition of the British Journal of Surgery (BJS).

A

uthors Abduraheem H Mohamed (Hull York Medical School, Hull, UK) and colleagues note that, while international guidelines recommend postprocedural compression when treating symptomatic SVI, there is no agreed timescale for this. In order to investigate the optimal application of postprocedural compression, they carried out a systematic review of randomised controlled trials (RCTs).

Mohamed et al write that they used the UK National Institute for Health and Care Excellence’s (NICE) Healthcare Databases Advanced Search Engine to identify all English-language RCTs of compression following treatment for SVI. Postprocedural pain, venous thromboembolism (VTE), health-related quality of life (HRQoL) and anatomical occlusion were the main outcomes of interest, they note.

The investigators included 18 studies comprising

2,584 treated limbs in their systematic review.

Compression was compared with no compression in four studies, nine studies compared different durations of compression, and a further five compared different types of compression, Mohamed and colleagues relay.

Writing in BJS, the authors report that a one to two week period of compression was associated with

The optimal interface pressure and type of compression, and the impact on VTE risk, remain to be determined.”

Machine-learning software aids non-experts in performing “safe and efficient” remote DVT triage In a prospective, controlled clinical trial of deep vein thrombosis (DVT) triage using artificial intelligence (AI)-guided software simulating compression ultrasonography, lead investigator Efthymios Avgerinos (University of Athens, Athens, Greece) and colleagues demonstrated a high sensitivity and specificity in DVT diagnosis. The researchers concluded that the machinelearning software was able to aid non-experts in acquiring valid ultrasound images of venous compressions and allowed safe and efficient remote DVT triage. Avgerinos recently presented these findings at the 22nd European Venous Forum (EVF) annual meeting (30 June–2 July 2022, Venice, Italy).

DIAGNOSTIC ALGORITHMS for DVT typically require a clinical probability test assessment, a standard lower leg duplex or, at a minimum, two-point compression ultrasound and D-dimer testing. These can be time consuming for both patients and physicians in an otherwise busy emergency room or vascular ultrasound lab, Avgerinos told Vascular News.

AutoDVT (ThinkSono), a machine-learning software, is an AI tool guiding non-specialists in acquiring appropriate two-point

(common femoral and popliteal veins) compression sequences. At EVF, Avgerinos detailed that a smartphone or tablet and a wireless ultrasound probe are the only equipment needed to use this technology, and that users upload captured images to the cloud, which are then reviewed remotely by an expert.

In Avgerinos et al’s study, the investigators recruited patients with a suspected DVT at two tertiary centres: Magdeburg, Germany and Athens, Greece. Enrolled patients underwent an AutoDVT scan by a non-ultrasound-

a mean reduction of 11 (95% confidence interval [CI] 8–13) points in pain score on a 100mm visual analogue scale compared with shorter duration (p<0.001). Mohamed et al also reveal that this was associated with improved HRQoL and patient satisfaction, however note that greater than two weeks’ compression did not add further benefit.

“There was low-quality evidence suggesting that 35mmHg compression with eccentric thigh compression achieved lower pain scores than lower interface pressures,” the authors add, noting also, “there were no significant differences in VTE rates or technical success in any group, including no compression”.

In their conclusion, Mohamed et al acknowledge the evidence gaps that persist: “The optimal interface pressure and type of compression, and the impact on VTE risk, remain to be determined”.

qualified healthcare professional prior duplex scan confirmed as negative. to the standard duplex scan. Two to four Of the 14 patients triaged as high risk, external qualified physicians blindly seven were positive for DVT. These reviewed images collected results accounted for a sensitivity by the software that had been of 100% and a specificity of 77% uploaded to a cloud-based for DVT diagnosis. platform. All reviewers, based on these images only, rated all Faster diagnosis Efthymios sequences on the American and treatment Avgerinos College of Emergency Speaking to Vascular News after Physicians (ACEP) image quality scale the presentation, Avgerinos summarised (score 1–5, with a rating of three or the key findings of the study: “The above defined as sufficient diagnostic machine-learning software was quality) and made a triage decision: low able to aid non-experts in acquiring or high risk for DVT. Categorisation valid ultrasound images of venous was compared to DVT diagnosis by the compressions and allowed safe and standard duplex scan. efficient remote triaging. Given that Addressing the EVF audience, the vast majority of the requested DVT Avgerinos reported that three nurses scans are negative, such a triaging scanned 37 patients (age 63.7±17.01, strategy allows faster diagnosis and body mass index [BMI] 28.62±5.9, treatment of high-risk patients and can 32% females), resulting in 34 (97%) spare the need and cost of multiple scans that were judged to be of unnecessary duplex scans. Patient diagnostic quality. Average ACEP waiting times can be reduced, and scores were 3.88±0.43, and there radiologist and sonographer resources was no significant difference in the can be reallocated.” proportion of diagnostic quality of “The ThinkSono investigators are scans between reviewers or scanners, excited to evaluate these findings on the presenter relayed. a larger scale,” the presenter added, In addition, Avgerinos communicated noting that several European sites are that AutoDVT triaged 23 (62%) scans incorporating this new technology and as negative, all of which the standard commercial pilots are underway.

Issue 95 | September 2022

Advertorial 25

THIS ADVERTORIAL IS SPONSORED BY INARI MEDICAL

ClotTriever deemed a “game-changer” in deep vein thrombosis treatment “I am finally very confident I have a device that takes out all the thrombus,” stated Rick de Graaf (Clinical Centre of Friedrichshafen, Friedrichshafen, Germany) in a discussion on the current state of deep vein thrombosis (DVT) at the Leipzig Interventional Course (LINC) 2022 (6–9 June, Leipzig, Germany). De Graaf was here referring to the ClotTriever (Inari Medical) device, which he believes addresses the “major problem” of residual thrombus and offers the “game-changing” solution that is extending the treatment window.

AT LINC 2022, DE GRAAF—WHO IS director of radiology, interventional radiology and nuclear medicine at the Clinical Centre of Friedrichshafen—was joined by Andrew Wigham, consultant interventional radiologist at Oxford University Hospitals NHS Trust (Oxford, UK), to discuss the latest developments in the field of DVT for Vascular News. In particular, they shared their clinical experience and expert opinions on the ClotTriever device for DVT treatment.

The problem

The pair first considered the “state of play” with DVT in Europe and highlighted a key issue in the patient journey. “For years now, we have been looking to build awareness,” said De Graaf, who noted, “we are treating the patients, but the patients get referred to us by general physicians who do not know that we can treat these patients well”. He stressed that this is a problem across Europe, citing in particular his experience with this lack of awareness in Germany and in The Netherlands. Wigham confirmed this is also a “huge issue” in the UK. According to Wigham, a lack of awareness ultimately affects DVT treatment. He explained: “One of the major problems we see relates back to the awareness issue. We know the traditional devices enable us to have only a limited window for effective treatment of acute DVT. Beyond two to three weeks, the clot becomes too organised and some of our currently available treatments are ineffective.” The problem, Wigham highlighted, is twofold: patients are often referred too late and many treatments do not work beyond a very limited time window.

Wigham also referenced an issue that came to the fore in the UK during the COVID-19 pandemic— the costs of delayed treatment to both patients and hospital systems. “We had limited operating time, we had limited bed availability,” he recalled, “and one of the traditional treatments for acute DVT has always been thrombolysis, which comes with significant bleeding risk to the patient and has a significant impact on the health economics of a hospital in that it requires an ITU [intensive therapy unit] stay and oneto-one nursing.” This, Wigham noted, underscored the need for solutions to address the issues associated with treating patients who are referred late in order to

want to do to young patients,” he relayed. “We went through all of the devices out there, and my major problem was always that I could not get the thrombus out.” The issue here, he explained, is that residual thrombus incurs a new thrombosis. “Thankfully, now, I am finally very confident that I have a device that takes out all the thrombus,” he reported, referencing the ClotTriever device. “That is the key thing— removing all the thrombus—and we now have that.”

Wigham also uses ClotTriever in his practice, and describes the device as “very effective” in enabling interventionalists to clear thrombus and potentially limit the amount of stenting performed in what is typically a young patient population. This, according to De Graaf, is something those in the venous community have been talking about for “years”.

In chronic cases, he explained, stenting might be necessary; however, in the acute setting he advised against stenting residual thrombus. Instead, De Graaf underlined the important of stenting the cause of the thrombus. “Only stent the lesion that causes the DVT in the first place,” he recommended. Wigham expressed his optimism in this regard thanks to the ClotTriever device: “I think we are in a position to do that.”

Finally, the pair addressed the question of timing, referring back to the two- to three-week window they deemed crucial for successful treatment. “Do you think that ClotTriever is only possible to use inside that window of two weeks?” De Graaf asked ClotTriever® device

avoid haemorrhagic or bleeding risk from a traditional thrombolytic therapy.

The solution

De Graaf—who Wigham described as a “big advocate” of interventional treatment for DVT— outlined the evolution of his treatment modality for DVT patients. “In 2009, we started with thrombolysis, and that is something that you definitely do not

Rick de Graaf

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Wigham. He responded that it is one of the “principal advantages” of the device that it is effective beyond two weeks. In fact, he noted that he has witnessed its effectiveness out to six weeks. “I would even say it is possibly more effective in that subacute phase, because you get such good luminal clearance,” he remarked.

“I think that is the real game-changer […] that we have that range of treatment time available to us now,” Wigham summarised, homing in on the significance of this key benefit of the ClotTriever device, in addition to its ability to remove all residual thrombus. De Graaf agreed this is a huge benefit: “Sometimes, you just get referrals too late. This is a game-changer.”

Indications for use: The ClotTriever thrombectomy system is indicated for (1) the non-surgical removal of thrombi and emboli from blood vessels, and (2) injection, infusion and/or aspiration of contrast media and other fluids into or from a blood vessel.

The ClotTriever thrombectomy system is intended for use in the peripheral vasculature including deep vein thrombosis (DVT). See Instructions For Use for complete Indications For Use, contraindications, warnings and precautions. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

26 Advertorial THIS ADVERTORIAL IS SPONSORED BY CARDIONOVUM®

September 2022 | Issue 95

Such low concentrations of paclitaxel in the bloodstream, as found in our study, may provide us the proof that the Safepax® (Cardionovum) coating, thanks to its non-crystalline structure, effectively limits the drug dispersion in blood.

Matteo Tozzi, associate professor of Vascular Surgery at the University of Insubria In terms of clinical outcome, we published an (Varese, Italy), speaks to Vascular News about a new analysis related to the residual article evaluating the safety and efficacy of this presence of paclitaxel in the bloodstream after the use of a drug-coated balloon (DCB) technology using the Aperto® (Cardionovum) overin arteriovenous fistulas (AVFs). the-wire (OTW) DCB for the management of venous stenosis in arteriovenous grafts and AVFs in patients Can you please tell us more about this for those who are very suspicious of the efficacy undergoing haemodialysis. The results coming from new analysis? and safety of paclitaxel in the treatment of 311 angioplasty procedures in 200 patients Our study aims to investigate, in humans, the presence neointimal hyperplasia. are extremely positive with a freedom from of the drug in the circulatory system at various time restenosis of 88% at six months and 64% at intervals after DCB use. Currently in the literature we Did the decision to perform 12 months. have experimental data in animals, but not in humans. this analysis come from your The results of a recently published The method used, thanks to collaboration with daily practice? multicentre randomised clinical trial Luciano Piubelli of the Biochemistry Laboratory of Our use of DCBs never stopped. Clinical reinforced these positive data. In this study, Matteo Tozzi the University of Insubria, is high-performance liquid data on the follow-up of patients undergoing more then 160 patients were analysed and at chromatography (HPLC), which is a particularly peripheral treatment have always assured us six months, the percentage with target lesion sensitive instrumentation that has allowed us to of their first-line role. The DCBs in use today offer primary patency in the DCB group was significantly evaluate the presence of paclitaxel in the blood the most effective treatment since they respond to the superior to that in the control group (high-pressure samples taken. pathophysiology of neointimal hyperplasia. plain balloon) as well at 12 months in clinically driven The concentration of the drug, present only in the target lesion revascularisation. samples immediately following DCB deployment, Safety is a hot and sensitive topic: how reaches concentrations below 20nmol/L. Such low important is it for you, and it is the key Do you believe that this analysis could concentrations confirm that these dosages are far feature you are looking for in a DCB? be repeated in other anatomical areas below those that can be tolerated, thus they cannot Safety is of primary importance with any medical such as the superficial femoral artery? have systemic effects according to the ‘dose–effect’ treatment. For this reason, we are convinced that Our study has just started; these are the preliminary principle. our study will bring positive evidence on this issue. data related to the treatment of vascular access The other aspect is treatment efficacy: this is directly stenosis. However, we will also enrol patients In your opinion, why is this related to the amount of drug that can be delivered undergoing peripheral and coronary revascularisations study important? to the target lesion. This feature is determined by the with DCBs. I believe that this study can add to the abundant DCB coating, which characterises the influence of the The balloon sizes—and the distinct haemodynamic evidence in the literature supporting the safety of paclitaxel uptake to the vessel wall. It must also avoid differences—are also very interesting to investigate, DCBs. Currently, the strength of the clinical and drug dispersion during radiological manoeuvres and although we do not expect any significant change in experimental evidence is extremely strong—even blood navigation. the drug concentration in the bloodstream.

New data bolster safety and effectiveness of Safepax DCB coating technology

Issue 95 | September 2022

Venous Stenting 27

VENOUS

Retrospective study is “first to systematically explore predictors of venous stent occlusion”

N

ew data indicate that venous stent failure “may be predicted by low peak flow velocity and post-thrombotic changes in inflow veins” and that endovascular venous stenting for chronic outflow obstructions is an “efficacious and safe” treatment in selected patients.

These findings were recently published online ahead of print in the Journal of Vascular Surgery: Venous and Lymphatic Disorders (JVS-VL).

The authors of the study—Ulrike Hügel (Bern University Hospital, Bern, Switzerland) and colleagues—write that endovenous stent placement has become a first-line approach to prevent post-thrombotic syndrome in patients with chronic postthrombotic obstruction (PTO) or non-thrombotic iliac vein lesions (NIVLs) if conservative management fails. “This study aims to identify factors associated with loss of patency to facilitate patient selection for endovenous stenting,” Hügel et al state.

The investigators retrospectively analysed 108 consecutive patients following successful endovenous stenting for chronic vein obstruction performed at a single institution from January 2008 to July 2020.

They explain their methods in the JVS-VL paper: “Using multivariable logistic regression, we explored potential predictive factors for loss of stent patency, including baseline demographics, post-thrombotic changes as well as peak flow velocities measured in the common femoral vein (CFV), deep femoral vein (DFV) and femoral vein (FV) using duplex ultrasound.”

Key findings

Hügel and colleagues detail that the mean follow-up duration was 41±26 months and that participants, 46.3% of whom were women, had a mean age of 47.4±15.4 years. They add that 90 (83.3%) patients had PTO and 18 (16.7%) had NIVLs. Loss of patency occurred in 20 (18.5%) patients

who were all treated for PTO, the authors communicate, noting also that comorbidities, side of intervention and sex did not differ between patients with occluded and patent stents.

“Stent occlusion was more common with increasing number of stents implanted (p<0.001) and with distal stent extension into and beyond the CFV (p<0.001),” Hügel et al report in JVS-VL. The authors also reveal that lower duplex ultrasound peak velocity in the CFV (odds ratio [OR] 7.52; 95% confidence interval [CI] 2.54–22.28; p<0.001) and FV (OR 10.75; 95% CI 2.07–55.82; p<0.005) was a

Stent occlusion was more common with increasing number of stents implanted and with distal stent extension into and beyond the common femoral vein.”

Iliac vein stenting should remain a viable treatment option for higher BMI patients Despite greater comorbid conditions, patients with obesity benefitted as much as patients with normal body mass index (BMI) from iliac vein stent placement for proximal venous outflow obstruction (PVOO) in a study from a research group in New York. Jinseo Kim (Icahn School of Medicine at Mount Sinai, New York, USA) presented the study findings at this year’s Society for Vascular Surgery (SVS) Vascular Annual Meeting (VAM 2022; 15–18 June, Boston, USA).

KIM AND COLLEAGUES OUTLINE IN AN abstract that it was their aim to determine the role of BMI in iliofemoral vein stent placement among patients who are normal weight, overweight, and those with obesity.

In order to achieve this, the research team retrospectively analysed a clinical registry of 624 patients who underwent iliofemoral vein stenting for chronic PVOO from 2011 to 2021. The team divided patients into three groups based on their BMI: normal (n=250, 18.5≤BMI≤25), overweight (n=249, 25≤BMI≤30), and obese (n=125, BMI≥30).

Among patients with PVOO undergoing vein stent placement, Kim informed VAM attendees that the prevalence of obesity was 20% (n=125) and overweight was 39.9% (n=249) with mean BMIs of 35.3kg/m2 and 27kg/m2, respectively.

The presenter noted that diabetes (normal: 16% vs. overweight: 22.5% vs. obese: 40.8%; p<0.001),

preinterventional predictive factor for stent occlusion. Post-thrombotic changes in the DFV (OR 4.51; 95% CI 1.53–13.25; p=0.006) and FV (OR 3.62; 95% CI 1.11–11.84; p=0.033), they add, was another predictive factor. Finally, the authors state that peak velocities of ≤7cm/s (interquartile range 0–20) in the CVF and ≤8cm/s (IQR 5–10) in the FV were “significantly associated with loss of patency”.

Discussion

In the discussion of their findings, Hügel and colleagues claim that their study is the first to systematically explore predictors of venous stent occlusion that can be incorporated into the decision-making process prior to an intervention. They also acknowledge “several” limitations to their study, noting, for example, that the sample size was “moderate” and that the retrospective, single-centre design and midterm follow-up duration limit the generalisability of the results.

“Insufficient venous inflow as assessed by low peak velocities in the CFV and FV as well as postthrombotic findings represent reliable risk predictors for stent occlusion, warranting their inclusion into the decision-making process for invasive treatment of PTO,” the authors conclude.

conditions, patients with obesity benefited as much as patients with normal BMI from iliac vein stent placement for PVOO, as reflected in similar improvement in VCSS composite scores.

“Obesity does not impact iliofemoral stent hypertension (40.8% vs. 75.2% vs. 52.6%; p<0.001), outcomes,” Kim concluded, adding that the coronary artery disease (CAD; 7.6% vs. 26.2% vs. procedure “should remain as a viable treatment 9.3%; p<0.001), cancer history (10.4% vs. 19.2% option for those who have higher BMI and those vs. 9.6%; p=0.017), and mean Clinical, Etiological, with obesity”.

Anatomical, and Pathophysiological (CEAP) class In the discussion following Kim’s presentation, (3.4 vs. 3.7 vs. 3.5; p=0.017) differed significantly moderator Misty Humphries (University of across the three groups.

California Davis Health, Sacramento, USA) Univariate logistic regression, Kim revealed, questioned how these findings might change practice. showed that obesity was associated with increased Kim responded: “I think obesity is very prevalent risk of major reintervention (odds ratio [OR], 1.88; among the US population, and providing a solid 95% CI, 1.13–3.06; p=0.013). The speaker added option of treatment for those patients who have a that, after controlling for age, gender, CAD, race/ higher BMI is very important.” ethnicity, and diabetes status, the association One delegate commented from the floor between obesity and major reintervention that it is “very comforting” to know that became no longer significant (OR, 1.06; patients with obesity can get the same 95% CI, 0.5–2.17; p=0.882). benefit as that demonstrated in prior Furthermore, he communicated that lograndomised controlled trials for this type rank test similarly showed no difference of procedure. in reintervention-free survival for major or Another delegate expressed some Jinseo Kim minor reoperations among those who were caution, however, stressing that “we need of normal, overweight, or obese to be careful with reintervention” in this BMI (p=0.4). patient group, because obesity “cuts out the open Finally, the presenter noted that improvement option,” and multiple endovascular interventions in mean Venous Clinical Severity Score (VCSS) “may compromise long-term outcomes.” composites preoperatively to postoperatively Speaking to Vascular News following Kim’s (p=0.802), one-year follow-up (p=0.111), and presentation, senior author of the study Windsor five-year follow-up (p=0.44) showed no differences Ting (Mount Sinai Health System, New York, USA) across the three groups. responded to this concern: “Reintervention we found He summarised that patients classified as being to be an excellent option to extend the benefits and either overweight or obese were prevalent among outcomes of vein stenting among these patients. vein stent patients. Kim added that, after controlling Very few vascular surgeons resort to an open option for the risk factors associated with greater comorbid in this disease.”

Issue 95 | September 2022

Access Creation 29

VASCULAR ACCESS

Intraoperative vascular mapping during haemodialysis access “should be incorporated into routine practice”

The investigators compared intraoperative measurements of the veins used for fistula creation to preoperative measurements of the veins in the same anatomic location, the presenter explained. She added that the researchers reviewed the preoperative mapping and analysed Intraoperative ultrasonographic venous mapping is a useful which haemodialysis access would tool to evaluate vessel suitability for arteriovenous fistula have been created if intraoperative (AVF) creation, Yana Etkin (Zucker School of Medicine at mapping was not performed.

Hofstra/Northwell, Lake Success, USA) concluded at this The presenter reported at VAM year’s Society for Vascular Surgery (SVS) Vascular Annual that, on average, intraoperative vein Meeting (VAM 2022; 15–18 June, Boston, USA). measurements were about 1mm larger than preoperative vein diameters ACCORDING TO THE institution between 2019 (3.6mm vs. 2.5mm) and presenter, the technique may increase and 2021, Etkin informed that this was consistent in the rate of distal fistula creation and the VAM audience. The all anatomic sites including lower the rate of graft replacement, and team only included patients forearm cephalic vein, therefore “should be incorporated into who had intraoperative upper arm cephalic vein routine clinical practice”. and preoperative vein and basilic vein. The team Etkin and colleagues note in the measurements recorded. also found that anaesthesia Yana Etkin abstract of their study that there is The presenter detailed that type did not significantly currently no consensus on how best the operating surgeon performed affect intraoperative measurements. In to evaluate the suitability of vessels intraoperative measurements and that patients who had regional anaesthesia, for AVF creation. They write that use the certified vascular lab carried out the mean intraoperative vein diameter of preoperative sonographic vascular preoperative measurements. was about 3.6mm, compared to 3.4mm mapping performed by a vascular Etkin noted that site selection for in patients who had local anaesthesia. imaging facility is common despite a fistula creation was based on distal When looking at preoperative lack of evidence on AVF outcomes. to proximal and superficial vein first mapping alone, Etkin revealed that The goal of this study was to evaluate approach. This meant that the team 71% of patients would have the same the utility of intraoperative vascular considered radiocephalic fistulas first access created. Ten percent of patients mapping performed by the operating followed by brachiocephalic and then would require a more proximal fistula surgeon during access creation. brachiobasilic fistulas, the presenter created utilising superficial veins, 13% The research team performed a explained. Veins with a diameter of at of patients would have fistulas created single-institution, retrospective study least 2mm on intraoperative mapping using deep veins, and 6% of patients of 239 AVFs that were created in their were used for fistula creation. would require a graft, the presenter

Device-created fistulas keep future options open, but are not a replacement for surgery Based on more than four years of experience in a single centre, Robert Shahverdyan (Asklepios Klinik Barmbek, Hamburg, Germany) claims that device-based arteriovenous fistula (AVF) creation “keeps future options open”, but is not a replacement for surgical fistula creation.

S

peaking at the Leipzig Interventional Course (LINC; 6–9 June, Leipzig, Germany), Shahverdyan reported new outcomes from his long-term experience with the Ellipsys (Medtronic) and WavelinQ (BD) systems, as well as with more traditional, surgically created AVFs. The presenter stressed that current studies of end-stage kidney disease show an ageing patient population with an increasing number of comorbidities. Additionally, these studies highlight lengthening waiting times for a transplant, surpassing 10 years in many cases. “As vascular access creators,” he said, “we are confronted with longer dialysis needs, and longer access needs.”

More than 500 patients were screened at his vascular access centre over the course of four years, and Shahverdyan noted that 46% were eligible for a radiocephalic surgical fistula, while 80% had a suitable perforating vein for a surgical Gracz fistula. He noted that suitability for the Ellipsys and WavelinQ systems is dependent on a patient’s anatomy. In the Hamburg experience, he continued, around 61% of patients had suitable anatomy for at least one type of device-based creation, and 23% had suitable anatomy for both systems.

Shahverdyan noted that, over the past four years, he has used the VasQ device (Laminate Medical) as a standard of care in radiocephalic AVFs. From more than 750 creations included in the Hamburg data, 92% are AVF creations, with 86% of all access creations having a forearm anastomosis, he detailed.

There were also around 200 device-created fistulas, 126 Gracz AVFs and 63 arteriovenous grafts (AVGs).

The rest were radiocephalic fistulas—a group also including 80 snuffbox fistulas.

The technical success for both surgical and device-created AVFs was “really high”, he relayed.

In terms of physiological maturation for fistulas that were more than four weeks old post-creation, Shahverdyan reported a >90% rate for VasQ radiocephalic fistulas, and almost 90% for Ellipsys and Gracz fistulas, while snuffbox and WavelinQ were “a little bit behind” with maturation rates of roughly 80%. Regarding clinical maturation, Robert Shahverdyan assessed in patients whose

added. In this subset of 70 patients who had a different access created based on intraoperative mapping, maturation rates were similar, at 84% as compared to 88% in the rest of the cohort.

There was widespread agreement with Etkin’s conclusions among the VAM audience, with one delegate likening the research to a consensus statement. This prompted the presenter to question why the guidelines do not yet endorse the intraoperative mapping as a standard of care. “That is why we wanted to put these data out there, to see if there is interest in adding the recommendation of intraoperative mapping into national guidelines”.

We wanted to put these data out there to see if there is interest in adding the recommendation of intraoperative mapping into national guidelines.”

fistulas were subsequently used for dialysis, he reported a >90% cannulation success rate for Ellipsys and radiocephalic AVFs. High flow and steal are also important factors to consider, said Shahverdyan, due to the fact that the fistulas in question are being created for long-term use. He reported seeing “practically no steal” in distal fistulas, just one case of steal with Ellipsys, and high rates of surgical steal and high flow for Gracz fistulas, particularly if they had a brachial artery-based anastomosis. In terms of assisted and secondary patency rates, the Ellipsys, radiocephalic and Gracz fistulas all had patency rates higher than 80% in the four-year Hamburg experience. In Shahverdyan’s opinion, primary patency rates “are not important”— except in cases with frequent reinterventions.

Comparing proximal forearm AVFs, and remarking here on procedure time, the presenter detailed that this was “significantly shorter” for Ellipsys, and that time to cannulation was shortest for Ellipsys and Gracz fistulas. The number of interventions per patient was “slightly higher” for Ellipsys, but this system resulted in the fewest abandoned fistulas, closely followed by Gracz.

Shahverdyan concluded by stressing that “we need to consider some learning curves” for device-created AVFs, but also surgical fistulas, to address issues like kinking and torsion. He summarised that there are “some differences” between the Ellipsys, WavelinQ, and surgical fistulas, but added that device-based creation has an “extremely low” rate of perioperative complications. Shahverdyan then reiterated that device-created fistulas enable future intervention, but should be seen as complementary to the vascular access surgeon’s armamentarium, rather than a complete solution.

r a l u c s a V s i r Pa ights Ins

Get ready for PVI 2022 in Paris!

November 23-25 I 2022 Palais Brongniart I Paris

CHAIRMEN Eric Ducasse

Koen Deloose

GRAND AUDITORIUM 08:30 09:00

ACCESS & PASSAGE

-

WEDNESDAY 23

-

PARALLEL PLENARY EDUCATIONNAL SESSIONS HANDS ON WORKSHOPS EDUCATIONNAL SESSIONS HANDS ON WORKSHOPS -

LUNCH IN THE EXHIBITION HALL TIPS & TRICKS AND LIVE IN THE BOX AORTA

AV ACCESS SESSION

CLINICAL STUDIES

16:30

BREAK IN THE EXHIBITION HALL ARCH AND THORACIC AORTA

TIPS & TRICKS AND LIVE IN THE BOX PAD

18:30

END OF SESSIONS

07:30

WELCOME COFFEE

EDUCATIONNAL SESSIONS HANDS ON WORKSHOPS

EDUCATIONNAL SESSIONS HANDS ON WORKSHOPS

PAD JIF @PVI

EDUCATIONNAL SESSIONS HANDS ON WORKSHOPS

09:00

-

-

10:20

BREAK IN THE EXHIBITION HALL

08:30

THURSDAY 24

PREPPING & TREATING

14:30 16:50

MD, PhD, Professor of Vascular Surgery, Le Plessis-Robinson, France

BREAK IN THE EXHIBITION HALL

13:00

18:00

VENOUS SESSION

10:50

VASCUPEDIA@PVI COMPLEX AORTIC ANEURYSMS

12:30

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13:00

LUNCH IN THE EXHIBITION HALL

14:00 14:30

MORE ON PREPPING & TREATING

16:15 16:35

BEST OF PEAC - LIVE IN THE BOX

MORE ON PREPPING & TREATING

TIPS & TRICKS AND LIVE IN THE BOX AORTA -

18:30

END OF SESSIONS

20:00

OFFICIAL DINNER

07:30

WELCOME COFFEE CAROTIDS - SYMPTOMATIC

10:15 10:45

AAA +

SHORT ORAL PRESENTATIONS

EPOSTERS PRESENTATIONS

EDUCATIONNAL SESSIONS HANDS ON WORKSHOPS

VENOUS

VENOUS

LUNCH IN THE EXHIBITION HALL EMBOLISATION IMAGING AND MORE

16:15 17:15

EDUCATIONNAL SESSIONS HANDS ON WORKSHOPS

BREAK IN THE EXHIBITION HALL

13:00 14:00

EDUCATIONNAL SESSIONS HANDS ON WORKSHOPS

BREAK IN THE EXHIBITION HALL

17:30

08:30

FRIDAY 25

SMALL AUDITORIUM

12:30

14:00

Stéphan Haulon

MD, PhD, Professor of Vascular Surgery, Paris, France

WELCOME COFFEE

10:35 11:00

Yann Gouëffic

MD, PhD, Professor of Vascular Surgery, Bordeaux, France

MD, Vascular Surgery, Dendermonde, Belgium

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VENOUS

BREAK IN THE EXHIBITION HALL MISCELLANEOUS

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18:30

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END OF SESSIONS

Detailed program available online Online registration www.parisvascularinsights.com

ORGANISATION Vérane Bergeron Tél. +33 (0) 491 57 19 62 • Port. +33 (0) 621 788716 • Fax. +33 (0) 491 57 19 61 vbergeron@divine-id • 17, rue Venture - 13001 Marseille • www.divine-id.com

Issue 95 | September 2022

Journal Highlight 31

VASCULAR ACCESS

AVeVA study confirms benefit of covered stent placement in graft-vein anastomotic stenosis treatment

A prospective, multicentre study involving the Covera vascular covered stent (BD) has confirmed the benefits of immediate, post-percutaneous transluminal angioplasty (PTA) placement of the device in treating arteriovenous graft (AVG) venous anastomotic stenosis when anatomically and clinically suitable.

Writing in the Journal of Vascular and Interventional Radiology (JVIR), Bart Dolmatch (Palo Alto Medical Foundation, Mountain View, USA) and colleagues report a 30-day freedom from safetyrelated events of 96.4% and a six-month target lesion primary patency (TLPP) of 70.3% with the Covera stent.

THE AUTHORS BEGIN BY noting that, as per three prospective, multicentre, randomised trials, placement of a covered stent has previously led to statistically superior TLPP rates compared to PTA alone in restoring flow and maintaining haemodialysis access.

They add that the current study, AVeVA (Arteriovenous stent graft in the treatment of stenosis at the graftvein anastomosis of AV graft circuits), examined a self-expanding nitinol covered stent (Covera) that is more flexible than the device used in two of those prior studies (Flair, BD).

patency, number of reinterventions, index of patency function (IPF), and adverse events through two years.

Of the 181 patients who gave informed consent to participate, 71 did not meet the study eligibility criteria—with 75% deemed not to have angiographic evidence of ≥50% stenosis and clinical evidence of graft dysfunction—meaning 110 patients (mean age=64.3 years, 54.5% female, mean body mass index [BMI]=28.7kg/ m2) were ultimately enrolled and treated with the Covera device. The vast majority (98.2%) had an upperarm AVG.

AVeVA study

New Covera data

Between August 2016 and February 2017, 110 patients were treated by investigators across 14 US centres in AVeVA—a single-arm, investigational device exemption (IDE) study without a concurrent control. Dolmatch and colleagues note that, because prospective trials of previous-generation covered stents had been completed and published, and the devices had been approved by the US Food and Drug Administration (FDA) for the indication being studied, pooled mean values from these trials as well as additional published data on the use of PTA alone for haemodialysis graft stenosis were used to develop safety- and patency-related performance goals for AVeVA. The primary safety endpoint was 30-day freedom from an adverse event involving the access circuit resulting in additional intervention, surgery, hospitalisation or death. The primary efficacy endpoint was sixmonth TLPP, or the interval following treatment until the next clinically driven reintervention at the site of the target lesion or until the AVG was abandoned. Prespecified secondary endpoints included acute technical and procedural success, access circuit primary patency (ACPP), cumulative

The authors detail that the mean anastomotic lesion stenosis at the time of treatment was 71.5%, decreasing to a mean residual stenosis of 21% following PTA predilation. One covered stent was used to treat each study lesion, meaning 110 stents were deployed, and all but two of these were postdilated. The mean residual stenosis at procedure completion was 0.9%, Dolmatch and colleagues report. In all cases, the covered stent was deployed to the intended location and eliminated preprocedural symptoms of access dysfunction—constituting a technical and procedural success rate of 100%.

Bart Dolmatch

All but two patients (98%) resumed dialysis after the procedure using their AVG. At 30 days, freedom from adverse events was 96.4%. Four patients (3.6%) required additional reintervention and one patient (0.9%) underwent required/ prolonged hospitalisation. The primary safety endpoint was therefore adjudged to be superior to the performance goal of 88% derived from prior studies and existing literature.

A total of 102 patients (92.7%) were available for the six-month primary efficacy analysis. TLPP at six months was 70.3% among these patients, the authors detail, and this was deemed superior to the prespecified performance goal of 40%. The only observed difference in patient subgroup analyses related to thrombosed AVGs, as those who presented with thrombosis within 30 days of the index procedure and/or at the time of the procedure demonstrated inferior TLPP rates at six months to those in non-thrombosis groups. Dolmatch and colleagues note that reasons behind this are unknown, but the fact this was observed in their study supports the “long-suspected belief” that a thrombosed AVG is more likely to fail due to TLPP loss, even when treated with a covered stent.

Noting secondary endpoint data, which they say should be considered observational and were calculated at predetermined intervals through the end of the study, the authors state that the Kaplan-Meier survival estimates for TLPP were 54.2% at 365 days and 36.9% at 730 days after the procedure, while Kaplan-Meier survival estimates for ACPP were 40.4%, 16.7%, and 7.8%, at 180, 365 and 730 days, respectively. A total of 91 adverse events across 53 patients (48.2%) were reported through 24 months, and 18 patients experienced device- or

A comparative, powered, randomised study would be needed to determine patency differences between different covered stents within the same demographic population.”

procedure-related events, meaning 86.3% were free from such events at 24 months.

Concluding messages

The Covera stent did an “adequate job” of maintaining target lesion patency over time, they add, but the “marked” and “ongoing” loss of ACPP (7.8% at 24 months) indicates that—regardless of TLPP improvement with a covered stent—some AVGs may be prone to recurrent stenosis or the development of new stenoses elsewhere in the circuit. The authors state that the 24-month cumulative circuit patency rate of 73.6% further supports this notion, and the finding that TLPP was “acceptable” with covered stent placement. The mean number of reinterventions to maintain patency was 1.6 at the treatment site and 3.6 in the access circuit at 24 months.

Dolmatch and colleagues conclude their JVIR report by noting that AVeVA was designed as “a first-in-human look at the Covera covered stent” in treating AVG venous anastomotic stenosis— and it demonstrated rates of freedom from major adverse events at 30 days (96.4%) and TLPP at six months (70.3%) that were both superior to literature-devised performance goals.

They also note, however, that AVeVA is not directly comparable with other, similar trials like FLAIR Pivotal, RENOVA and REVISE, and outline limitations of the current study, such as the inclusion of thrombosed AVGs and nontarget stenoses (rather than a more homogenous AVG group), and the potential for an “inherent bias” being created by its single-arm design and the selection of historical studies.

“A comparative, powered, randomised study would be needed to determine patency differences between different covered stents within the same demographic population,” the authors add.

Freedom from adverse events at 30 days =

96.4% Better than performance goal of 88%

Target lesion primary patency at six months =

70.3% Better than performance goal of 40%

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Issue 95 | September 2022

Launch Pad 33

Launch Pad

Gender equality in vascular surgery: A long way to go In this edition of Launch Pad, vascular trainee Claire Dawkins addresses the question: how do we make surgery an equally accessible career for both men and women?

I HAVE BEEN INCREDIBLY LUCKY OVER MY career so far. I have always worked with teams that have treated me as an individual, not discriminating against me for my gender. Despite this, there are certainly times I have faced more difficult situations than my male colleagues simply for being a woman.

Evidence suggests that it is more difficult to succeed in surgery as a woman when compared to our male counterparts. Hope et al showed that in the UK being female is statistically significant for getting an adverse Annual Review of Competency Progression (ARCP) outcome. But why is this? Is it because ARCP panels are prejudiced? Or are female surgeons not as good as their male colleagues? I do not think either of these are true and I am certain that the answer is not that simple.

The fact that Ellis et al have shown that in Membership of the Royal College of Surgeons (MRCS) Part A, an examination that objectively tests factual knowledge with computer marking of

multiple-choice questions, has a significantly lower pass rate in female trainees (39.1% vs. 53%), suggests this is not a simple case of sexism from ARCP panels. Realising that this statistical significance is lost when it comes to Part B, where prejudice could theoretically be more apparent, further supports this.

Looking across the pond to our American colleagues, Yeo et al identified an interesting difference in pass rates in the American Surgical Board Exams between genders. Men have similar pass rates whether single, partnered or with children (79.8%; 83.8%; 80.7%). However, women have a better pass rate to the men when single (90.3%) but this plummets to 75.4% when partnered and dive bombs to 55.6% with children (Figure 1). Once I got over my excessive self-congratulations at defying the odds and passing my FRCS whilst partnered, pregnant and with a toddler, this made me consider whether gender equality in modern surgery is intrinsically flawed or if it is actually the extrinsic effect of society.

Even before you consider individual incidences of gender prejudice, bullying and sexual misconduct towards women there is systemic prejudice against women in surgery. This does not stem just from the surgical world but is put in place by society as a whole. However modern and forward thinking we think our society is, it is women who are managing a majority of households and families across the country, with female surgeons juggling those extra demands and responsibilities with a surgical career. Of course, this is not the case in every family or household, but this traditional setup certainly seems to be more prevalent than the equality we might hope for in the 21st century.

The question is how do we make

Start-up’s 3D printing technology shows potential in surgical preparation and training “Three-dimensional (3D) printing unlocks the opportunity to greatly increase the efficiency of surgical procedures,” write Chiel de Nijs and Rutger Visser (both University of Twente, Enschede, The Netherlands) on the website of the company that they recently founded—3D Medical Support. Based on a mutual interest and academic background in 3D printing, the pair have developed a production method to 3D print a flexible, transparent, 3D material that can be used to print computed tomography (CT) scans of abdominal aortic aneurysms (AAAs) for surgical preparation and training. Vascular News caught up with the entrepreneurs to hear more about their work.

Can you provide a brief overview of the technology?

RV: Our technology essentially bridges a gap in the 3D printing market. There are currently two main types of 3D printers used for this subject: on the one hand, you have fused filament fabrication (FFF) 3D printers, which are fast and cost-efficient, and on the other you have a technology that is called material jetting, and this is mostly used for intricate jobs, resulting in it being expensive and unable to print large structures within required timeframes.

There is a big gap in the market between these two technologies for a 3D printer that is fast and cost-efficient, but also

very precise.

In the summer of 2020, Chiel and I decided to see if there was something we could do here. After a lot of work and experimenting we came up with a technology that would enable us to quite rapidly print precise patterns on a transparent and flexible material. We knew that we needed to make people aware of this and so we got in touch with the University of Twente and they helped us take that idea forward.

This all has resulted in our company, which provides a service. From CT segmentation all the way to a unique high quality print within 24 hours.

Percentage pass rate on the American Board of Surgery Exams (Yeo et al).

surgery an equally accessible career for everyone?

As much as we would like to have an equal society, we have to accept that we are not there yet, not even close. Making gender equality in surgery a priority is a first step to achieve a society where everyone is able to thrive in a surgical career. Ending systemic social prejudice is an almost impossible task but the only way to make surgery truly accessible to all.

References 1. H ope C, Lund J, Griffiths G, Humes D. Differences in progression by surgical speciality: a national cohort study. BMJ Open. 2022 Feb 9; 12(2): e053391.

2. E llis R, Brennan PA, Lee AJ, et al. Differential attainment at MRCS according to gender, ethnicity, age and socioeconomic factors: a retrospective cohort study. JR Soc Med. 2022 Jul; 115(7): 257–272.

3. Yeo HL, Dolan PT, Mao J, Sosa JA. Association of demographic and program factors with ABS qualifying and certifying examinations pass rates. JAMA Surg. 2020; 155(1):22–30.

What are the potential benefits of this technology in vascular surgery?

CLAIRE DAWKINS is a vascular trainee at the Newcastle Upon Tyne Hospitals NHS Foundation Trust in Newcastle, UK and a committee member for the Rouleaux Club, the UK national vascular trainee society.

RV: There is a 2018 Innovative Surgical Sciences paper by Inez Torres and Nelson De Luccia (both São Paulo University Medical School, São Paulo, Brazil) which showed that products such as ours can be used to boost a surgeon’s confidence in 42% of procedures and even leads to the selection of a better procedure in 20% of cases. We have also received affirmative feedback from a market pilot study we have recently completed together with W L Gore & Associates. This kind of technology is changing the outcome of surgery.

CDN: Right now we are focused on AAAs, because those are aneurysms that occur very frequently. We want to develop that first and expand in the future to the rest of the vascular system

We really trust this technology and, with the feedback that we have received, it is going in the right direction.”— Rutger Visser

and maybe even to smaller vascular structures such as brain aneurysms.

What are the next steps for this technology?

CDN: We are focusing on collaborations, for example with surgical robotics teams. A company called Flux Robotics, which is also based here at the University of Twente, has developed a magnetic robot that is used to guide catheters through the vascular system. Normally, surgical or clinical validation is very difficult as you need cadaver studies or even very specific cases, however we realised that our 3D models could be used here to develop the robots further. The same goes for training. In the near future, we really want to develop our material characteristics so that they resemble real anatomy even more closely.

RV: We believe that there is a change coming and that we are ahead of the curve Product in this region of 3D printing photo within the medical field. We are completely backed up by science and now it is time for the science to back us up.

The next steps are collaborating with solid partners, implementing our 3D models and building on new applications where hospitals, physicians and patients will benefit. Furthermore, we are on the verge of collaborating with another world leading medical company.

September 2022 | Issue 95

34 Market Watch

Clinical News

LIMES study team at the University Hospital Münster Germany

First patients enrolled in LIMES randomised trial of Magic Touch sirolimuscoated balloon in BTK interventions

Concept Medical has announced the initiation of the LIMES trial, which has enrolled 15 patients to evaluate the safety and efficacy of the company’s Magic Touch sirolimus-coated percutaneous transluminal angioplasty (PTA) balloon for the treatment of peripheral arterial disease (PAD).

A Concept Medical press release elaborates that LIMES is a prospective, multicentre, randomised controlled trial (RCT) that is designed and aimed to evaluate the Magic Touch balloon 0.014” and 0.018” versus standard angioplasty in a head-to-head comparison (1:1).

Initiated by the University Hospitals Jena and Leipzig in Germany and led by principal investigator (PI) Ulf Teichgräber (Jena University Hospital, Jena, Germany) alongside co-PI Thomas Zeller (University Heart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany) and Dierk Scheinert (University Hospital Leipzig, Leipzig, Germany), the trial kicked off with the index patient enrolled on 31 March 2022 by Nassan Malyar at the University Hospital Münster in Münster, Germany.

LIMES RCT is set to enrol 230 patients in 19 centres across Germany and Austria. The patient population will include patients presenting with documented chronic limb-threatening ischaemia (CLTI) in the target limb defined as Rutherford clinical category 4, 5 or 6 aged ≥18 years. The study evaluates patients with a reference vessel diameter (RVD) ≥2 and ≤4mm and total occlusions (100% stenosis) of the target lesion. There is no minimal lesion length required, no lesion length limitation and no limitation in number of used devices. Follow-up will be per in-house visits at 30 days, six, 12, 24 and 36 months.

The RCT will measure the efficacy of sirolimus-coated balloons in a complex setting (CLTI) of the PAD segment (located below the P3 segment of the popliteal artery to the tibiotalar joint) against the current standard of care. The study’s primary endpoints are the composite of limb salvage and primary patency through six months.

The key secondary safety endpoint is

the composite of major adverse limb events and perioperative death at 30 days. A blinded core lab will assess patency at six, 12 and 24 months by duplex ultrasound and quantitative vascular angiography in case of any target lesion revascularisation.

In the press release, Teichgräber commented on why the RCT is valuable in terms of DCB intervention in infrapopliteal occlusions: “BTK [below-the-knee] revascularisation deals with the most challenging vascular territory in very sick patients.

LIMES will solve the question if sirolimus balloon angioplasty has the potential to become the future standard of care in BTK interventions.”

iVascular announces first patients enrolled in BARISTA clinical trial

iVascular recently announced the first patient enrolment in the BARISTA study, a Belgian physician-initiated study to assess the efficacy and safety of the company’s Restorer balloonexpanding stent for the treatment of aortoiliac lesions.

BARISTA is a prospective, singlearm, multicentre, physician-initiated study led by Lieven Maene (Onze Lieve Vrouw Hospital, Aalst, Belgium) who enrolled the first two patients, achieving excellent flow rates after the implantation of the Restorer.

In total, 131 Belgian patients from 13 different hospitals will be included in this study with the purpose of assessing the long-term (up to 24 months) safety and efficacy of the Restorer in a controlled clinical setting on the treatment of complex TASC A, B, C and D aortoiliac lesions.

The primary endpoint of the study is freedom of any target lesion revascularisation (TLR), major amputation or restenosis (defined as significant stenosis on duplex ultrasound (>50%, systolic velocity ratio greater than 2.4) within 12 months. Secondary endpoints include technical success during procedure, and during the follow-up period: primary patency, stent occlusion rate, ankle brachial index (ABI), freedom from TLR, clinical success (improvement of Rutherford classification), change in walking impairment questionnaire, change in quality-of-life questionnaire, freedom from above-the-ankle target limb amputation, and mortality.

Patients will have one-month, sixmonth, 12-month and 24-month followup visits.

According to iVascular, the unique design of the Restorer CoCr stent provides excellent radial force with the minimum amount of metal to maintain the artery lumen and avoid restenosis.

The company adds that the device is crimped on an Oceanus percutaneous transluminal angioplasty balloon, which offers outstanding navigability and profiles (6Fr introducer compatible for all diameters).

“Our centre has a huge experience using Restorer. With the BARISTA study, we aim to confirm the excellent clinical results we had in the past in a scientific way and demonstrate the outstanding performance of the Restorer stent system,” Maene highlighted.

USA), who implanted the first AMDS in the trial, said: “I am thrilled to be participating in the PERSEVERE study and to have treated the first patient with the AMDS in the USA. Implantation of the device was simple and added minimal time to the surgery. On the post-op CT scan we saw expansion of the true lumen and resolved malperfusion. Additionally, there was no presence of distal anastomotic new entry (DANE), which gives confidence that the aorta will continue to remodel positively over time and decrease the risk of future reoperation.”

Artivion initiates enrolment in PERSEVERE clinical trial

Artivion announced today that it has initiated enrolment in the PERSEVERE clinical trial to determine if patients with an acute DeBakey Type I aortic dissection can be treated safely and effectively using the AMDS hybrid prosthesis. The trial is designed to support the company’s forthcoming application to the US Food and Drug Administration (FDA) for premarket approval of the AMDS. The PERSEVERE trial is a prospective, multicentre, nonrandomised clinical trial consisting of approximately 100 participants in the USA, who have experienced an acute DeBakey Type I aortic dissection.

Each participant will be followed for up to five years. The combined primary efficacy and safety endpoints will determine the impact of the AMDS hybrid prosthesis on reducing mortality, new disabling stroke, myocardial infarction, and new onset renal failure requiring dialysis, and also re-expansion of the true lumen of the aorta.

“We are pleased to announce that the first patient in our PERSEVERE clinical trial has been enrolled at Hartford Hospital,” said Pat Mackin, chairman, president, and chief executive officer of Artivion. “Through the PERSEVERE trial, we will study the safety and efficacy of the AMDS to treat patients suffering from acute DeBakey Type I aortic dissections, a life-threatening condition characterised by extremely high mortality rates.”

Mackin added: “If the trial proceeds as planned and meets its endpoints, we believe we can achieve FDA approval for patient access to the AMDS in late 2024 or early 2025.”

Wilson Szeto (Penn Presbyterian Medical Center, Philadelphia, USA), the PERSEVERE national principal investigator, said: “Acute aortic dissection is a devastating disease with high morbidity and mortality.

The surgical treatment is technically demanding. With the PERSEVERE trial, we intend to show the benefits that AMDS brings to patient outcomes and expand the therapy to more surgeons.”

Principal investigator Mohiuddin Cheema (Hartford Health, Hartford,

Paradise ultrasound renal denervation system

Ultrasound renal denervation meets primary efficacy endpoint in RADIANCE II study

ReCor Medical and Otsuka Medical Devices have announced that the RADIANCE II US Food and Drug Administration (FDA) investigational device exemption (IDE) pivotal trial evaluating the Paradise ultrasound renal denervation (uRDN) system as a treatment for hypertension met its primary efficacy endpoint, demonstrating a statistically significant reduction in daytime ambulatory systolic blood pressure between treatment and a sham procedure measured at two months.

RADIANCE II is a randomised, sham-controlled clinical trial of the ReCor Paradise uRDN system for the treatment of patients with uncontrolled hypertension. 224 patients with mildto-moderate uncontrolled hypertension, previously treated with up to two medications, were randomised while off medications at more than 60 study centres in eight countries.

“Despite the truly formidable challenges of conducting a complex clinical trial in the throes of the COVID-19 pandemic, we are thrilled to observe these positive results of RADIANCE II, especially in light of those we have previously reported from RADIANCE-HTN SOLO and TRIO,” said principal investigators Ajay Kirtane (Columbia University, New York, USA) and Michel Azizi (Hôpital Européen Georges Pompidou, Paris, France). “We cannot adequately convey our thanks to the patients, coordinators, and study physicians for their collective efforts, and we very much look forward to being able to present and publish the complete study details in the near future.”

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September 2022 | Issue 95

36 Market Watch

Product News Endologix receives CE mark certification under EU-MDR for AFX2 endovascular AAA system

Endologix recently announced that is has received CE mark certification under the new EU Medical Devices Regulation (EU-MDR) for its AFX2 endovascular abdominal aortic aneurysm (AAA) system.

“CE mark certification under the new requirements is a high bar and we are proud of this significant company achievement. Meeting the rigor of the new framework is an important milestone for our AFX2 system,” said Elisa Hebb, Endologix’s EVP of Medical, Clinical, Regulatory Affairs and Quality.

“We believe AFX2 offers an innovative solution for AAA and continues to play a significant role in clinical practice due to its differentiated design features and the compendium of clinical evidence,” said Matt Thompson, president and CEO of Endologix, “We are committed to investing in clinical research to evaluate the long-term outcomes of our products. Evidence to date supports the comparative effectiveness of AFX2 in the treatment of patients with abdominal aneurysms.”

The currently marketed AFX2 system was introduced in 2016 and its comparative performance is studied in the LEOPARD randomised controlled trial. The study was designed to directly compare AFX2 and the predecessor AFX device, to other commercially available endografts.

A company press release advises that the five-year results of this study will be available later this year, while the four-year results demonstrated that freedom from aneurysm related complications was similar between the AFX and AFX2 cohort and comparator endografts.

Impede embolisation plug expanded

Shape Memory Medical celebrates treatment of 1,500th patient

Shape Memory Medical announced today that its 1,500th patient has been treated, marking a significant milestone for the company’s portfolio of shape memory polymer embolotherapy devices—the Impede embolisation plug family and the TrelliX embolic coil.

The patient was treated by Thomas Maldonado (NYU Grossman School of Medicine and NYU Langone Health,

New York, USA).

“We were excited to perform our first case using shape memory polymer technology, and in this particular case for the occlusion of the internal iliac artery for prevention of post-EVAR [endovascular aneurysm repair] type II endoleak,” said Maldonado.

According to a company press release, shape memory polymer is a new concept in medical devices, built on 25 years of polymer research and expertise initiated at Lawrence Livermore National Laboratory (LLNL; Livermore, California) and further developed at Texas A&M University (College Station, USA). Shape memory polymer features a porous, compliant polyurethane embolic material that enables conversion to organised thrombus followed by gradual healthy tissue formation. In 2009, Shape Memory Medical was formed to develop and commercialise devices for use in the peripheral and neurovascular embolisation markets. An emerging alternative to traditional, bare metal embolisation devices, shape memory polymer is soft and conformable, and the material is radiolucent which improves visibility of the surrounding anatomy during and after the procedure.

“This milestone is especially significant for Shape Memory Medical,” said Ted Ruppel, chief executive officer. “This accomplishment is only the beginning of our plans for this emerging technology, with a product pipeline focused on the development of shape memory polymer solutions for aortic aneurysms and aortic dissection.” The company is also pursuing research and development and corporate licensing partnerships for potential applications across multiple therapeutic areas such as aortic therapies, structural heart, biopsy, and drug delivery.

Since the launch of the Impede embolisation plug family in the USA, Europe, and Japan and the TrelliX embolic coil in Europe, these novel devices have been used by vascular surgeons and interventional radiologists in over 25 countries. The growing body of evidence presented from the podium and in the literature has raised physician awareness and interest in the Impede and TrelliX devices, including data from the TrelliX APEX study and the IMPEDE EMBO postmarket surveillance study. The Impede-FX RapidFill device is also currently being evaluated in a first-in-human safety and efficacy trial for a potential new indication for abdominal aortic aneurysm (AAA) sac management during elective endovascular aneurysm repair (EVAR). “Early AAASHAPE results are encouraging,” said Michel Reijnen (Rijnstate Hospital, Arnhem, The Netherlands),

principal investigator, AAA-SHAPE Netherlands. “Shape memory polymer technology has the potential to improve post-EVAR sac regression, reduce secondary interventions, and reduce the burden for our patients as well as for healthcare systems.” The AAA-SHAPE trial is ongoing, with one-year results expected to be announced in 2023.

2Fr XO Cross 14 microcatheter shown with a 0.014”

Transit Scientific announces XO Cross success in CLTI pedal artery access

Transit Scientific has reported multiple successful peripheral vascular procedures with the XO Cross catheter platform utilising pedal retrograde access.

The non-tapered 2Fr XO Cross 14 microcatheter in 90cm, 135cm, and 175cm lengths is designed to facilitate guidewire support, guidewire exchange, and contrast media injection during complex peripheral vascular interventions.

“2Fr 014 catheter-guidewire systems are an important tool for pedal and below-the-knee interventions,” said George Adams (UNC REX Healthcare, Raleigh, USA). “The XO Cross incorporates a non-tapered torquable shaft design which supports a smaller and less invasive access site from below. Tools like these can help broaden options for approaches and access techniques in CLTI [chronic limb-threatening ischaemia] patients.”

According to a Transit Scientific, the XO Cross catheter platform introduces new levels of pushability, trackability, flexibility, and torque response to access challenging lesions and complex anatomy. XO Cross’s non-tapered, metal-alloy and polymer construction delivers high fatigue resistance against tough lesions found in late-stage peripheral arterial disease (PAD) and CLTI, the company claims.

Richard Saxon (Tri-City Medical Center, Oceanside, USA) shared: “A patient presented with trifurcation disease and severe calcifications in the superficial femoral artery (SFA), popliteal, and the posterior tibial artery.

The low-profile and pushability of the XO Cross 14 enabled pedal retrograde access following failed crossing and wire from above. A second XO Cross 14 (135cm) was used from above to support a flossing technique and subsequent angioplasty treatment. The unique non-tapered design of the XO Cross lends itself well to challenging limb salvage procedures that often require multiple access sites and different approaches to achieve a good outcome.”

Transit Scientific’s XO Cross platform features 24 US Food and Drug Administration (FDA)-cleared devices

including 2Fr XO Cross 14 microcaths, 2.6Fr XO Cross 18 microcaths, and the 3.8Fr XO Cross 35 support catheters for use with standard 0.014”, 0.018”, and 0.035” guidewires in 90cm, 135cm, 150cm, and 175cm lengths.

Biotronik’s Pulsar-18 T3 peripheral self-expanding stent system receives FDA approval

Biotronik recently announced that it has received US Food and Drug Administration (FDA) approval of its Pulsar-18 T3 peripheral self-expanding stent system. Full US commercial launch of the device, which will begin in early August, according to the company.

Biotronik states that the Pulsar-18 T3 stent system uniquely combines three technologies. A 4Fr low-profile delivery system may decrease the risk of access site complications and reduce the need for closure devices when compared to 6Fr devices, the company claims. It adds that the triaxial system with braided shaft design facilitates stable and accurate implantation of the clinically proven Pulsar stent and, with its thin struts and low chronic outward force (COF), the Pulsar-18 stent contributes to a reduced mean area of restenosis.

The redesigned Pulsar-18 T3 stent system offers physicians an “intuitive and ergonomic” wheel-operated handle for one-handed stent release enhancing the ability to control deployment, according to Biotronik.

“I was immediately impressed by the new concept of the Pulsar-18 T3 system,” said Koen Deloose (AZ Sint Blasius Hospital, Dendermonde, Belgium). “The combination of having a very ergonomic handle combined with a triaxial system and also everything in a 4Fr concept was, for me, quite unique.”

“The Pulsar-18 T3 stent system is an innovative solution that delivers clinically proven performance— providing effective therapy that is easy to use for physicians while minimizing metal burden and may reduce the risk of restenosis for patients,” stated David Hayes, chief medical officer, Biotronik.

Biotronik will offer the Pulsar-18 T3 in up to a 200mm stent length for treatment of long lesions, the company advises.

Biotronik details that the Pulsar-18 T3 stent system is indicated for use to improve luminal diameter in patients with symptomatic de novo, restenotic or occlusive lesions located in the superficial femoral or proximal popliteal arteries, with reference vessel diameters from 3–6mm and total lesion lengths up to 190mm.

Northeast Scientific receives 510(k) for Turbo-Elite laser atherectomy catheter

Issue 95 | September 2022

Market Watch 37

Product News reprocessing

Northeast Scientific, a company that reprocesses single-use peripheral vascular catheters, announced recently in a press release that it has received US Food and Drug Administration (FDA) clearance for reprocessing the Philips Spectranetics 0.9mm over-thewire Turbo-Elite laser atherectomy catheter.

This is the first time the FDA has awarded a 510(k) clearance for reprocessing this type of atherectomy catheter.

The device is used to treat peripheral arterial disease (PAD) and emits highenergy ultraviolet light to vaporise blockages inside the vessels.

Chief executive officer and and founder Craig Allmendinger discussed what this means to the company, saying, “It is validating to receive this clearance from the FDA after all the work our team undertook to meet the standards of earning a 510(k).

The team at the FDA pushed us hard, and rightfully so, to prove that our methods and processes created an equivalent device to the original after reprocessing.”

He went on to say, “There is no doubt now that what we are doing is helping redefine the medical device

landscape as we add another device type to our reprocessing portfolio. As we continue to expand our device types and reach, we look to further help the office-based lab physician and never compromise on patient safety.”

The company has said that it will have an additional announcement soon regarding when the 0.9mm over-thewire Turbo-Elite laser atherectomy catheter device will be available for sale.

Ra Medical Systems receives FDA 510(k) clearance for the Dabra 2.0 catheter Ra Medical Systems has announced receipt of US Food and Drug Administration (FDA) 510(k) clearance for the company’s Dabra 2.0 catheter as part of the Dabra excimer laser system.

A company press release details that the catheter features enhancements including a braided overjacket design that is intended to improve deliverability and kink resistance when navigating tortuous anatomy, as well as a six-month shelf life.

“While we are pleased to receive this regulatory clearance, it comes as our board continues its evaluation of strategic alternatives to optimise our company’s path forward in the current

challenging economic review of strategic environment,” said Will alternatives, Ra Medical McGuire, Ra Medical Systems advises.

Systems CEO. “As we have previously Terumo Aortic announced, the Dabra announces first 2.0 catheter represents commercial an interim step in our implant of the work to develop a Thoraflex Hybrid Thoraflex guidewire-compatible device in the USA Hybrid version of the Dabra Following the recent catheter, and at this time we approval by the US Food and have no plans to commercialise the Drug Administration (FDA) of the Dabra 2.0.”

Thoraflex Hybrid frozen elephant On 16 May 2022 Ra Medical trunk (FET) device for the treatment Systems disclosed that its board of patients with complex aortic arch of directors is reviewing strategic disease, Terumo Aortic has now alternatives with the goal of announced the first commercial implant maximising shareholder value. In of the device in the USA. conjunction with this review, on 6 Thoraflex Hybrid is a single use June 2022 the company filed a report medical device combining a Gelweave on Form 8-K with the Securities polyester graft with a Nitinol selfand Exchange Commission (SEC) expanding stent graft. It is indicated for announcing initiation of a reduction in the open surgical repair or replacement force under which approximately 65% of damaged or diseased vessels of the of the company’s full-time employees aortic arch and repair of the descending were terminated. Non-terminated thoracic aorta with or without employees were offered conditional involvement of the ascending aorta, in retention arrangements for a period of cases of aneurysm and/or dissection. approximately 60 days from the date The implant was performed by the of the filing to allow for evaluation and principal investigator of the Thoraflex monitoring of the company’s nearHybrid study, Joseph Coselli, professor, term personnel needs based in part on executive vice chair, division of the company’s financial status and the cardiothoracic surgery at Baylor board’s review of strategic alternatives. College of Medicine (Houston, USA).

The purpose of the reduction in force “The procedure was very successful, is to preserve capital with the goal of the device performed well, and the maximising the opportunities available patient is making a good recovery”, to the company during the board’s said Coselli.

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September 2022 | Issue 95

38 Market Watch

Industry News

FlowTriever thrombectomy device

Inari Medical announces leadership succession plan

This week Inari Medical announced that chief operating officer Drew Hykes will succeed Bill Hoffman as chief executive officer, effective 1 January 2023. Hykes will join Inari’s board of directors and Hoffman will also continue to serve on the board.

Hykes joined Inari in 2017 as chief commercial officer and has served as the company’s chief operating officer since 2020. Prior to Inari, he served in various leadership roles at both public and private medical device companies.

“A proven operating executive with broad functional, geographic and sector experience, [Hykes] has leveraged decades of experience in the medical device space to advance the company’s mission of effectively treating venous thromboembolism and transforming

the lives of patients suffering from venous diseases,” a company press release reads.

“Drew is a talented leader, and he is the single best problem solver I have ever seen. More important, he is committed to the beautiful simplicity of our mission to impact the lives of our patients and their families in extraordinary ways, and to take care of our people along the way,” said chief executive officer Bill Hoffman.

“Drew has established the scalable and repeatable systems that have produced best-in-class growth in patient treatments and revenue, and he has developed the cross-functional processes that have resulted in the explosion of new products and new markets we are just beginning to see. His leadership style and his skill set could not be better suited to the complexities that our next phase of growth will require. I am personally excited to have a front row seat to watch him lead the best team in the medical device space.”

“I am incredibly humbled to be named as Inari’s next CEO,” said chief operating officer Hykes. “Inari has undergone tremendous growth and change since I joined in 2017. From a

venture backed, pre-commercial startup to an established public company with over 1,000 Clot Warriors, increasingly broad-based capabilities, and a shared ambition to change lives in the venous space and beyond.”

Michael Cerminaro to succeed Marvin Woodall as CEO of Thrombolex

Thrombolex has announced that its board of directors has named Michael Cerminaro chief executive officer (CEO) effective 13 July 2022, the date of the company’s most recent quarterly board meeting.

The company advises Cerminaro will also retain his current title of president.

Marvin Woodall, currently chairman and CEO, will serve as executive chairman and transition the CEO role to Cerminaro, currently president and chief operating officer. Both Woodall and Cerminaro are cofounders of Thrombolex and have been members of the board of directors since inception of the company in 2016.

During his tenure, Woodall led the company in transforming its business, with a focus on development of novel therapies to treat arterial and venous thromboembolic (VTE) disease, from an early-stage startup to a commercial stage innovator with seven US Food and Drug Administration (FDA)cleared devices. A primary focus of R&D and clinical investment under Woodall’s leadership has been the

development of a platform technology that has demonstrated best-in-class clinical data and exceptional early safety, a press release details.

“My decision to transition the CEO role to Michael has come at the right time for the company as our organisation is delivering strong progress and is positioned for continued success,” said Mr. Woodall.

“It has been an honour and privilege to lead Thrombolex as chairman and CEO, and I am pleased to serve as executive chairman to help oversee the company’s ongoing mission to bring innovative therapies to people all over the world. I am also immensely proud of how we have upheld the company’s legacy of delivering clinical therapies to address one of the most urgent, unmet clinical needs, treatment of arterial and VTE disease. I have the utmost confidence in Michael to lead Thrombolex as the company’s next CEO and I am confident that the future of Thrombolex is in very capable hands.”

On behalf of the board, Paul Stewart, one of the independent members of the board of directors, expressed his gratitude to Woodall: “Marv’s leadership and accomplishments since inception have been extraordinary and Thrombolex is much stronger, more diverse and much better positioned to succeed in today’s evolving healthcare marketplace due to his exceptional stewardship.”

Calendar of events 10–14 September Cardiovascular and Interventional Radiological Society of Europe (CIRSE) Barcelona, Spain

cirse.org/events/cirse-2022

12–16 September XIX World Congress of Phlebology Istanbul, Turkey uip2022.org

20–23 September 36th European Society for Vascular Surgery (ESVS) Annual Meeting Rome, Italy

esvs.org/events/annual-meeting

24–26 October CX Aortic Vienna 2022 Digital Edition Digital cxaortic.com

30–31 October The VEINS Las Vegas, USA

viva-foundation.org/veinsprogramming

31 October–3 November Vascular InterVentional Advances (VIVA) Las Vegas, USA viva-foundation.org/

15–19 November VEITHsymposium New York, USA

veithsymposium.org/index.php

23–25 November Paris Vascular Insights (PVI) Paris, France

2023 25–28 April Charing Cross (CX) Symposium 2023 London, UK cxsymposium.com

parisvascularinsights.com/

23–25 November The Vascular Societies’ Annual Scientific Meeting Brighton, UK vascularsociety.org.uk

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Relay® Triple Branch*

Built to Accommodate The current standard of care in the treatment of aortic arch aneurysms remains open surgical arch replacement commonly combined with either a traditional or frozen elephant trunk (FET) technique.

These repairs require sternotomy, cardiopulmonary bypass (CPB), and hypothermic arrest (HA), which often present a prohibitive risk for elderly patients with multiple comorbidities.2 Branched devices represent an ideal construct for aortic endografts involving the arch vessels.2 Total endovascular arch branch repair is a single-stage procedure. A single procedure is especially beneficial in patients with aortic arch disease, as they tend to be fragile and at high operative risk.1 Initial experience with the Terumo Aortic branched devices shows technically successful procedures with • no strokes • no mortality in one year2 ** The third branch for the LSA can accommodate future intervention of the visceral aorta from a brachial approach, obviates the need for additional anaesthesia and avoids injury to surrounding structures, such as nerves and lymphatics.1 * Custom-made devices do not bear CE Mark. According to medical device law, physician prescription is required. Custom-made option is not available in the United States. **All 3 patients required secondary reinterventions and one expired due to a non-device related issue.