Vascular News 94 – June 2022 OUS Edition by BIBA Publishing

June 2022 | Issue 94

Featured in this issue:

www.vascularnews.com

Ukraine ESVS takes steps to support vascular surgery colleagues

Profile: Alexander Zimmermann

Launch Pad: Trainee perspective from Claire Dawkins

page 18

page 25

Perioperative outcomes of carotid endarterectomy not improved on dual versus single antiplatelet therapy At the time of carotid endarterectomy (CEA), surgeons should consider single antiplatelet therapy (SAPT) rather than dual antiplatelet therapy (DAPT). This is the conclusion of a new meta-analysis—reportedly the largest conducted on the topic to date—published in the European Journal of Vascular and Endovascular Surgery (EJVES).

Community-focused approach required to tackle global issue of unnecessary amputations A roundtable discussion at the recent 2022 Charing Cross (CX) International Symposium (26–28 April, London, UK) recognised a need to discover patients with a “hurting leg” sooner. Experts from across the globe also highlighted the importance of raising awareness and improving access—with approaches that are specific to individual communities—in order to tackle what the panel and audience agreed is a global and pressing issue.

nchor Roger Greenhalgh (Imperial College, one thing was clear, however, and that was the fact that half London, UK) highlighted a “very concerning” of all major amputees do not have diabetes. “Amputation trend of amputations taking place “without any inequality extends beyond diabetes,” the presenter stated. investigation whatsoever”. The aim of the CX roundtable, While he stressed that few detailed inequality data he stated, was to tackle this problem head on. have been published over the last seven years, a paper Naseer Ahmad (Manchester University Foundation by Ahmad et al gives an insight into 10 years of hospital Trust, Manchester, UK), who joined virtually, opened data for the period 2003–2013. The study included 42,294 the roundtable discussion with a presentation on major and 52,535 minor amputations, as well 255,545 inequalities in the epidemiology of amputations across revascularisations and described variations across England, England. The vascular surgeon highlighted regional, Ahmad told CX attendees. He reported that the amputation gender, and ethnic variations, and also underlined rate in those aged 50 and over was 26.3/100,000 the importance of looking beyond diabetes when across England, but noted that the average discussing amputation. varied across the country; in London it was He first outlined a 2019 paper by Maria below the national average, in the Midlands Davies (Bolton NHS Foundation Trust, it was around the same, and in the north of Bolton, UK) titled “The epidemiology England, it was above the national average. of major lower-limb amputation in The investigators found the same pattern All content is now England: a systematic review highlighting with revascularisation. In addition, Ahmad available on demand. Visit methodological differences of reported trials” revealed that the overall major amputation www.cxsymposium.com based on 25 years’ worth of data. The paper rate actually went down over that same time for more information found that it was difficult to compare changes period, but that inequalities between north and access options over time, Ahmad told the CX audience, as and south and between men and women basic epidemiological data within studies remained the same. were “very poorly described”. He noted that

CX 2022

Continued on page 4

“AT THE TIME OF CEA IN SYMPTOMATIC or asymptomatic patients with carotid stenosis, perioperative DAPT has no effect on the occurrence of the ischaemic CEA complications versus perioperative aspirin SAPT,” authors Jerry C Ku (University of Toronto, Toronto, Canada) and Shervin Taslimi (Kingston General Hospital, Kingston, USA) et al write. “However,” they note, “DAPT does result in an increase of haemorrhagic CEA complications.” These are the key findings behind the investigators’ recommendation of SAPT over DAPT at the time of CEA, although Ku, Taslimi and colleagues acknowledge that the overall quality of the available evidence is poor. In the introduction to their study, the authors highlight a lack of granularity in the available guidelines on this topic. “Consensus medical management guidelines recommend aspirin monotherapy for asymptomatic atherosclerotic carotid artery disease and DAPT with aspirin and the addition of clopidogrel or dipyridamole for symptomatic carotid artery disease,” they write. However, they stress that “it remains unclear whether the second antiplatelet agent should be withheld preoperatively and resumed after surgery to reduce bleeding risk or continued throughout the perioperative period to reduce the ischaemic complication risk in patients with symptomatic carotid stenosis.” This ambiguity is reflected in surgeons’ practice. “Surveys of surgeons who perform CEA have shown significant variations in perioperative antiplatelet prescribing patterns,” the authors communicate. “Although the vast Continued on page 6

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June 2022 | Issue 94

CX: The Hurting Leg

Community-focused approach required to tackle global issue of unnecessary amputations Continued from page 1

Ahmad summarised that the variation in amputation prevalence is as important as actual rates, and stressed that looking at variation within populations is key to reducing the rate, stating the crucial figures of 30% more amputations in the north compared to the south of England, nearly three times more amputations in men than women, and 70% more in Black than White populations. He also reiterated the statistic that half of major amputates do not have diabetes. He concluded that there is an “urgent need” for new data on this topic, but pointed to the latest findings from Greater Manchester—from 2015–2022—showing that inequality patterns remain. Following Ahmad’s presentation, the panel gave their thoughts on the scope of the issue, adding global perspectives and nuance to the issue of variation, as well as highlighting other aspects of the problem, such as patients being referred too late, and patients not going to see a specialist about their hurting leg in the first place. “You are describing a problem in England that reflects a problem internationally,” said Andrew Holden Andrew Holden (Auckland City Hospital, Auckland, New Zealand), pointing to the global nature of the issue. He expanded on this point with data from New Zealand: “In my city, the Maori and Pacific Island population of south Auckland has 2.5 times the amputation rate of the North Shore population, which is predominantly of European origin.” Manjit Gohel (Cambridge University Hospitals, Cambridge, UK) said that he would break down the regional aspect even more. “You have looked at regions,” he said to Ahmad, “but even within regions and within cities, there are enormous variations,” referencing a particular part of Norfolk in the UK that has double the amputation rate. “We need to use these data to drive changes and promote early diagnosis, which is the only way we are going to make a big difference”. Also on the subject of variation, Michael Edmonds (King’s College Hospital, London, UK) highlighted the importance of considering the socioeconomic element of the amputation levels. He referenced Hurst et al’s data from Glasgow in the UK that showed specific “hot spots and cold spots” for amputation linked directly to degree of deprivation. “Amputation has a very close relationship with low socioeconomic levels,” he told the CX audience. Gunnar Tepe (RoMed Klinikum, Rosenheim, Germany) raised the point that referring physicians, which he described as “the only link between the patient

and the hospital” sometimes refer patients too late. This was also highlighted by Marcus Brooks (North Bristol NHS Trust, Bristol, UK), who stressed that how quickly patients get to be seen by a specialist is key, and also Greenhalgh, who noted that many patients are “not even getting anywhere close” to the specialists who could make a diagnosis. These were points also raised in a 2021 European Journal of Vascular and Endovascular Surgery paper by Kristina Hagenström (University Medical Center Hamburg-Eppendorf, Hamburg, Germany) and colleagues. They found in a study of population-based data from 2013–2015 that nearly one fifth of patients with peripheral arterial disease (PAD) did not receive guideline-based vascular diagnostics three months before incidence of amputation. The focus of the discussion shifted from problem to solutions, with Keith Harding (Cardiff University, Cardiff, UK) proposing public awareness campaigns. Brooks reiterated the importance of this as a solution, but added that “we have got to have somewhere for the patients to go and be assessed”. He noted that, in the UK, patients come into the system via “too many pathways”. In this vein, Edmonds stated that “there should be timely access to the multidisciplinary foot clinic, which can act as a focus of care, especially in areas of socioeconomic deprivation”. Erin Murphy (Sanger Heart and Vascular Institute, Atrium Health, Charlotte, USA) proposed the idea of problem-based clinics as opposed to specialitybased ones, giving her experience of setting up an acute deep vein thrombosis (aDVT) clinic. “The two things that are being discussed are education and access,” Holden summarised. In terms of education, he pointed out that the medical community has successfully delivered the message that chest pain might be a heart attack. If a patient has a hurting leg, however, “they do not think that they might have severe venous disease or an arterial insufficiency that has a consequence,” he highlighted. Social media, Holden proposed, might be a good way to reach patients. On the topic of social media, Murphy proposed the idea of patient-centred symposia, while Edmonds pointed out that “a lot of our population are digitally deprived,” and reiterated the importance of facilitating ready access to specialised care for patients in the community. “Multiple approaches” are perhaps the way forward, Greenhalgh summarised. Ahmad was in agreement, stating that is it important to ask the population what works for them, with Murphy defining this idea as a “tailored approach to the community”. “Every community is different,” said Ahmad, “and every community needs its own approach. In terms of timeline, Gohel pointed out that “we have got a head start” in that “we know where the problem is”. “We have these inequality maps, so we know where we need to target these specific interventions,” he said.

News in brief

The latest stories from the vascular world

n “WORKFORCE CRISIS” IN VASCULAR SURGERY: COVID-19 challenges to vascular skills and training was a key topic on the agenda of the opening day of the 2022 Charing Cross (CX) International Symposium (26–28 April, London, UK). Speakers from around the world, including society representatives and vascular trainees, took to the podium to address this pressing global issue.

For more on this story go to page 8. n DEDICATED VENOUS STENTING: In an advertorial sponsored by Bentley, Michael Lichtenberg (Arnsberg Vascular Center, Arnsberg, Germany) speaks about his clinical experience with the company’s BeYond Venous self-expanding stent system. Launched in July 2020, this dedicated venous stent provides physicians with a strong stent option, offering in particular the best balance of the key attributes of high radial force, flexibility, and crush resistance, he tells Vascular News.

For more on this advertorial go to page 21.

n CAROTID STENTING VERSUS ENDARTERECTOMY: Pooled patient-level data from more than 2,500 asymptomatic, non-octogenarian subjects have shown that carotid artery stenting (CAS) achieved comparable short- and long-term results to carotid endarterectomy (CEA). The findings of this analysis have been published by Jon Matsumura (University of Wisconsin, Madison, USA) and colleagues in the Journal of Vascular Surgery.

For more on this story go to page 29.

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June 2022 | Issue 94

Top Stories

Perioperative outcomes of carotid endarterectomy not improved on dual versus single antiplatelet therapy Continued from page 1

majority would not stop aspirin prior to CEA, 43% and 55% of surgeons would stop clopidogrel prior to CEA for asymptomatic and symptomatic patients, respectively.” The authors state that their objective was to conduct a systematic review and meta-analysis of the perioperative outcomes of CEA on DAPT versus aspirin monotherapy in order to determine optimal perioperative management with these antiplatelet agents. What sets their study apart in the literature, according to Ku, Taslimi et al, is the addition of newly published articles, the subgroup analysis for symptomatic carotid stenosis, which had yet to be explored previously, and the use of improved statistical methodology over previous meta-analyses of SAPT versus DAPT for CEA. The investigators note that they searched the Web of Science, PubMed, and Embase databases from inception to July 2021. The main outcomes included ischaemic complications (stroke, transient ischaemic attack [TIA], and transcranial Doppler [TCD]measured micro-emboli), haemorrhagic complications (haemorrhagic stroke, neck haematoma, and reoperation for bleeding), and composite outcomes. Writing in EJVES, Ku, Taslimi and colleagues communicate that a total of 47,411 patients were

included in 11 studies, with 14,345 (30.2%) receiving DAPT and 33,066 (69.7%) receiving aspirin only. They report that there was no significant difference in the rates of perioperative stroke (odds ratio [OR], 0.87; 95% confidence interval Jerry Ku [CI], 0.72–1.05) and TIA (OR, 0.78; 95% CI, 0.52–1.17) despite a significant reduction in TCD-measured micro-emboli (OR, 0.19; 95% CI, 0.1–0.35) in the DAPT compared with the aspirin monotherapy group. In addition, the authors relay that subgroup analysis did not reveal any significant difference in ischaemic stroke risk between patients with asymptomatic and symptomatic carotid artery stenosis, and that DAPT was associated with an increased risk of neck haematoma (OR, 2.79; 95% CI, 1.87–4.18) and reoperation for bleeding (OR, 1.98; 95% CI, 1.77–2.23) versus aspirin. Finally, they highlight that haemorrhagic stroke was an under-reported outcome in the literature. Despite the present analysis representing what the authors claim to be the largest conducted on the topic to date, Ku, Taslimi et al also acknowledge some limitations of the study. For example, they write that this review was limited by the studies available in

The risks of performing carotid endarterectomy on dual antiplatelet therapy outweigh the benefits, even in patients with symptomatic carotid stenosis.”

ESVS supports Ukrainian vascular surgery colleagues amidst ongoing crisis Andriy Nykonenko and Pirkka Vikatmaa outline how the European Society for Vascular Surgery (ESVS) is hepling vascular surgeons in Ukraine continue to provide medical care amidst the ongoing crisis. THE WORLD HAS BEEN DEEPLY AFFECTED by the violent and needless war launched against Ukraine in February of this year, which is continuing to result in devastating injuries and loss of innocent human life. One of the first actions the ESVS took in condemning the Russian invasion was to publish a critical commentary in the European Journal of Vascular and Endovascular Surgery (EJVES) entitled ‘Urgent plea for an immediate stop to the Russian invasion of the Ukraine and respect for the legacy of Professor Nikolai Volodos’. Nikolai Volodos, the world-renowned pioneer of vascular and endovascular surgical techniques, studied in Ukraine. The Kharkiv Institute where he once worked has sadly been attacked in the countless strikes endured over recent weeks. The ESVS has been in close communication with Ukrainian colleagues since the beginning of the conflict, through the ESVS Councillor Andriy Nykonenko. In March, a campaign was launched to source and ship essential equipment, medication, vaccines, single-use materials and vascular prostheses required by institutions all over the country. Opening

the literature, as is the case in meta-analyses. “Most were retrospective reviews and other observational trials, with only two RCTs [randomised controlled trials],” they elaborate, adding that additional Shervin Taslimi subgroup analyses could not be performed as a result of the heterogeneity in reporting.” Another limitation the authors highlight relates to the drawbacks of the information available within the literature. “Reporting of ischaemic stroke outcomes for asymptomatic versus symptomatic carotid artery stenosis was lacking in many studies,” they note, stating that this limited the number of studies available for this subgroup analysis. In addition, they state that information on the timing of CEA in symptomatic patients and ischaemic events that occurred while waiting for surgery was also lacking. The reporting of haemorrhagic stroke was also limited in the literature. “The risks of performing CEA on DAPT outweigh the benefits, even in patients with symptomatic carotid stenosis,” Ku, Taslimi and colleagues conclude. They note, however, that the overall quality of studies was low, and suggest that “improved reporting of CEA outcomes in the literature is necessary”.

3 Figures 1 and 2. First shipment arrival to Ukraine. Figure 3. Kharkiv Institute, the home institute of the late Nikolai Volodos, received essential material as well Prasol V in the centre.

this channel of help was no mean feat and is the result of a combined effort of ESVS representatives, courageous Ukrainian vascular surgeons on the ground, the Finnish Society of Surgery and the support of organisations, hospitals, EU and government bodies. On top of major logistic collaboration with Finnish officials, Uppsala University Hospital, a private donator and Gore Medical supported the project with separate major donations. As we entered the third month of the terrible war, the positive news came that a first delivery of this essential equipment and medication was received on 21 April into the hands of Ukrainian colleagues. Thanks to the active organisation of Andriy Nykonenko and Yurij Jatsyna, the director of the Uzhgorod Regional Hospital (Figure 1), the contents of the truck were distributed among a number of vascular surgery centres who were desperately awaiting this aid. In an editorial in the May issue of the EJVES, Nykonenko, Maksym Karpusenko from Kharkiv, and Jean-Baptiste Ricco, who participated in the French humanitarian assistance, describe how the war affects the population and vascular surgery. The ESVS is proud to be able to support this critical project and a second delivery is now in transportation as there continues to be an immense need for further materials. If you or your organisation can donate, the ESVS is collecting funds that will go directly towards this effort. Vascular instruments and material donations are also welcomed. All the relevant information can be found on the ESVS website (www.esvs.org) or by contacting the ESVS office. Andriy Nykonenko is head of the Surgery Department at Zaporizhzhya State Medical University in Zaporizhzhya, Ukraine. He is also an ESVS Councillor. Pirkka Vikatmaa is a vascular surgeon, chief physician at Helsinki University Hospital in Helsinki, Finland. He is also president of the Finnish Society of Surgery and treasurer of the ESVS.

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June 2022 | Issue 94

Skills and Training

CX 2022 SYMPOSIUM

Experts address “workforce crisis” in vascular surgery on opening day of CX 2022 COVID-19 challenges to vascular skills and training was a key topic on the agenda of the opening day of the 2022 Charing Cross (CX) International Symposium (26–28 April, London, UK).

peakers from around the world, including society representatives and vascular trainees, took to the podium to address this pressing global issue. Anchor Roger Greenhalgh (Imperial College, London, UK) was joined by moderators Maarit Venermo (University of Helsinki, Helsinki, Finland), secretary general of the European Society for Vascular Surgery (ESVS) and Jason T Lee (Stanford University, Stanford, USA), president of the Association of Program Directors in Vascular Surgery (APDVS). Ginny Bowbrick (Gillingham, UK) was first to speak on the topic of COVID-19 challenges to skills and training. She spoke on vascular surgery training in the UK, highlighting a vascular surgery “workforce crisis” in the wake of the COVID-19 pandemic. The speaker pointed out that a 2021 Vascular Society Workforce and Wellbeing Survey, the results of which “suggest we need to increase the vascular surgeon workforce in the UK by an annual 2.79%, or 28% over the next 10 years to create 659 vascular surgeons by 2030”. Addressing the question of what can be done to tackle this problem, Bowbrick put forward the following suggestions: “We need to be clear as surgeons and trainers that educational recovery goes hand in hand with elective recovery. We need to involve trainees in every case, we need to keep lobbying everywhere that we can [...] because if we do not address educational recovery, we will have an ever worse workforce crisis and none of us will be able to retire.” Lee asked what strategies exist in the UK to increase interest in vascular surgery, to which Bowbrick responded that the Rouleaux Club, the UK Vascular Trainees’ Association, plays an important role in this regard. Next to speak, James Rammell (Freeman Hospital, Newcastle, United Kingdom) gave the Rouleaux Club view on the topic, speaking on COVID-19 and vascular surgical training in Great Britain and Ireland. Reporting the results of a survey sent out to Rouleaux Club members, Rammell detailed that 80% of respondents perceived a negative impact on their training and career progression. The survey also revealed that aortic cases were most seriously affected and that emergency operating helped fill the void of elective surgery. “I suspect that we may not see the true impact of how COVID-19 has affected vascular surgery training for years to come,” Rammell concluded. A question from a virtual attendee touched upon the importance of vascular trainees having general surgery training and general surgery trainees having vascular training in terms of distributing a slightly lower case volume. “I think it is very important for both specialties,” Rammell responded. Bowbrick noted that “we now talk a lot about the confidencecompetence gap,” asking for Rammell’s opinion on this. “I think competence is the most important thing for us to achieve,” Rammell remarked. “I think it is great that we are shifting away from minimum numbers, because that does not necessarily reflect how competent someone is.”

Finally, Venermo asked Rammell’s opinion on simulation training and whether it increases competence and confidence. “I think it is fantastic,” Rammell replied, adding, “if it could be well integrated, that would be a wonderful resource”. Stefano Ancetti (University of Bologna, Bologna, Italy) also picked up on simulation, stressing the importance of improving simulation-based training to make up for lost time during the pandemic and to be prepared for the future in a talk on COVID-19 as seen by the European Society for Vascular Surgeons in Training (EVST). He reported on a paper titled ‘The impact of the first COVID-19 wave on European vascular education’ by Ancetti and colleagues published this year in the European Journal of Vascular and Endovascular Surgery (EJVES) Vascular Forum. This aimed to evaluate the standpoint of vascular education across Europe during the first wave of the COVID-19 pandemic, identifying possible measures to mitigate the negative effects on vascular trainees. The results of a survey submitted to EVST-registered members between 7 July and 20 September 2020 highlighted a series of consequences of COVID-19 on vascular training. These included decreased operative volume as first operator and assistant, reduced exposure to outpatient clinic activities, decreased patient contact time, and final examinations being postponed or suspended.

As well as improving simulation-based training, Ancetti proposed intake assessment of trainees working during the pandemic and development of personalised additional training. He summarised that “pandemics, conflicts, and exceptional events happened in the past and could happen again the future,” stressing the importance of effective training and mentorship going forward. Next, Sophie Renton (North West London Hospitals National Health Service Trust, London, UK) spoke on COVID-19 challenges to the final Board Qualification in Surgery, addressing in particular the effect of the pandemic on the Joint Committee on Intercollegiate Exams (JCIE) Vascular Exam. She reported that there were no exams in May and July 2020 and no patients in the clinical section of the exam, pointing out, however, that this will be resuming in November 2022. Renton highlighted a fall in the percentage of candidates successful in the exam in both Part 1 and Part 2 due to a lack of preparedness, clinical experience, and exam preparation courses. Renton stressed that the exam is there to measure knowledge and not competence. “Competence takes place in the working environment via multiple consultant assessments,” she said. Renton also pointed out that perhaps we need to move to a more virtual environment for some of the didactic teaching, stressing that it has particular benefits for lectures and knowledge. She made it clear, however, that smallgroup learning needs to be continued. Dialling in from the USA, Palma Shaw (Upstate University, Syracuse, USA) delivered the viewpoint of the World Federation of Vascular Societies (WFVS). Shaw detailed that the WFVS is planning for future global collaboration with a focus on training innovation, the application of Global Vascular Guidelines, and improved vascular care in underserved areas. Venermo commended the focus on education, with Rammell remarking on the “exciting” nature of global collaboration in terms of education and training.

CX audience

I suspect that we may not see the true impact of how COVID-19 has affected vascular surgery training for years to come.” James Rammell

Finally, Lee addressed COVID-19 challenges on patients in North America, giving the Society for Vascular Surgery (SVS) view. He stressed that part of the role of vascular societies is to assure optimal surgical education of trainees. Lee pointed to vasculartraining.org—created by trainees for trainees, and sponsored and updated through resources provided by APDVS/SVS—a virtual platform for education and hybrid meetings, and also underlined the importance of advancing recruitment efforts and addressing wellness and professional/career satisfaction.

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June 2022 | Issue 94

10 CLTI: Position Statement

PERIPHERAL

SCAI releases multi-society position statement focused on core competencies for endovascular specialists providing care for CLTI The Society for Cardiovascular Angiography & Interventions (SCAI) has released a position statement outlining competencies for endovascular specialists who provide care for chronic limbthreatening ischemia (CLTI).

he first-of-its-kind document, “SCAI/ACR/APMA/SCVS/ SIR/SVM/SVS/VESS position statement on competencies for endovascular specialists providing CLTI care”, published in the Journal of the Society for Cardiovascular Angiography & Interventions (JSCAI), Journal of the American Podiatric Medical Association (JAPMA), Journal of Vascular Surgery (JVS), and Vascular Medicine (VMJ), is a collaborative effort from eight societies representing many specialties engaged in the care of CLTI patients. The expert writing group aims to standardise expected competencies for endovascular

specialists to help ensure patient-centric and evidence-based therapy is delivered to this unique patient population. “Care for patients with CLTI is typically complex, multifaceted, and multidisciplinary. Standardising expected competencies for endovascular specialists is an important step to ensure that patient-centric and evidence-based therapy is delivered,” said Beau M Hawkins (University of Oklahoma Health Sciences Center, Oklahoma City, USA), chair of the writing group for the document. “This new framework is a starting point to enable training programmes, professional medical societies, and other entities to develop curricula that

Majority of CX audience sees future for paclitaxel amid US FDA hesitancy THE PROXIMAL PERIPHERAL ARTERIAL Challenges session at the 2022 Charing Cross (CX) International Symposium (26–28 April, London, UK) concluded with the results of an audience poll on the question of whether paclitaxel had “had its day”. With 87% of the audience of the opinion that paclitaxel should continue to be used in peripheral arterial treatments, the consensus reflected the assertion from speaker Eric Secemsky (Beth Israel Deaconess Medical Center, Boston, USA) that “a lot has changed since [the US Food and Drug Administration (FDA)’s last advisory panel conclusion in] 2019”. While the 2019 advice from the FDA for “clear and transparent discussions regarding the benefits and risks of [paclitaxel]” stands today, the session’s speakers provided nuance to this caution, citing the lack of any mortality signal from significant datasets. In this session, Eleni Whatley (US FDA, Silver Spring, USA) gave an FDA regulator update on paclitaxel and Aloke Finn (CVPath Institute, Gaithersburg, USA) delivered a presentation on the vascular response of a polymer-free paclitaxelcoated stent versus a polymer-coated, paclitaxeleluting stent in healthy swine femoropopliteal arteries. An edited case by Jacob Budtz-Lilly (Aarhus University, Aarhus, Denmark) on overcoming the challenge of treating the aortoiliac bifurcation also featured.

address the needs of this unique patient population.” The position statement details the key skills that all endovascular specialists should possess to deliver successful outcomes for CLTI patients. The skillsets are categorised into six core competencies based on the Accreditation Council for Graduate Medical Education (ACGME) core competencies framework: medical knowledge, patient care and procedural skills, systems-based practice, practicebased learning and improvement, professionalism, and interpersonal and communication skills. To account for a range in complexity across the competencies, the writing group also provides examples stratified into “fundamental” and “advanced” categories. “This unprecedented collaborative effort among these eight multidisciplinary medical societies is another step owards advancing care for patients with CLTI,” said Mehdi

Shishehbor (University Hospitals Harrington Heart & Vascular Institute, Cleveland, USA), co-chair of the writing group. “I hope that these efforts will evolve and translate into better care for these high-risk patients at risk of limb loss,” he continued. The statement also discusses institutional requirements and resources necessary for learners to obtain the necessary skillsets. Recommendations for formal training or independent courses in a post-training practice are also included. The position statement was endorsed by the American College of Radiology (ACR), American Podiatric Medical Association (APMA), Society for Cardiovascular Angiography and Interventions (SCAI), Society for Interventional Radiology (SIR), Society for Vascular Medicine (SVM), Society for Vascular Surgery (SVS), Society for Clinical Vascular Surgery (SCVS), and Vascular and Endovascular Surgical Society (VESS).

This unprecedented collaborative effort among these eight multidisciplinary medical societies is another step towards advancing care for patients with CLTI.” Mehdi Shishehbor

Researchers develop predictive model for risk of amputation in diabetic foot patients In the Hurting Leg session at CX 2022, Ryan Tan (Singapore) outlined how he and colleagues used artificial intelligence (AI) to develop a predictive model for risk of amputations in patients with diabetic foot disease. Tan and principal investigator of the study, Joseph Lo (Singapore) speak to Vascular News about the pros, cons, and future of AI in this arena.

Could you briefly summarise the talk you delivered at CX 2022?

play into determining our patients’ outcomes, especially so within vascular patients who often present with multiple comorbidities. I believe a big strength of AI, in particular machine learning, allows us to try to recognise patterns within, and predict outcomes from, these complex relationships. Although some AI technology adopts black box machine learning algorithms, we strived to utilise explainable AI within our machine learning model.

Our team from the National Healthcare Group (Singapore) teamed up with the data scientists from Holmusk to develop a predictive model for the risk of amputations in our patients with diabetic Joseph Lo foot disease using data generated directly from our Electronic Health Records as well as wound data from eWounds, a nursing-led wound management database. We used various machine learning models to develop an algorithm that could accurately predict the risk of amputations What do you think the future of and found that with the Neural Ordinary AI in this area looks like? Ryan Tan Differential Equations, we were able to AI is an exciting new world for the field generate the most accurate predictions of medicine in general with much untapped with an AUROC [area under the receiver operating potential. I think that it will potentially change the characteristic curve] of 0.8. way we practise medicine and interact with our patients, using big data. I see it not only being used What do you think are the main pros in predicting outcomes, improving administrative and cons of using AI as a predictive processes, and helping to ensure guidelines-based model for risk of amputation in patients clinical decisions, but also in the interactions between with diabetic foot disease? healthcare providers and patients/carers. For example, The big advantage of using AI to develop a predictive AI bots may help guide patients along their healthcare model would be the ability to analyse the complex journey and to take charge of their own health at interactions between the multitude of factors that home, hence improving health literacy.

Issue 94 | June 2022

CLTI: New Research 11

PERIPHERAL

Non-optimal therapy for CLTI “more prominent in females” A real-world claims data analysis of nearly 200,000 patients with chronic limb-threatening ischaemia (CLTI) showed that female patients were older, underwent vascular procedures less often, and received guideline-recommended drugs less frequently. However, it also highlighted that female sex was associated with better outcomes. The study was recently published in the European Heart Journal. AUTHORS LENA MAKOWSKI (University Hospital Münster, Münster, Germany) et al state that the prevalence of CLTI is increasing, adding that available data often derive from cohorts with various selection criteria. “In the present study,” they communicate, “we included CLTI patients and studied sexrelated differences in their risk profile, vascular procedures, and longterm outcomes”. The researchers analysed 199,953 unselected patients of the AOK Health Insurance Fund—which they describe as the largest public health insurance in Germany—hospitalised between 2010 and 2017. They detail that female CLTI patients were older and more often diagnosed with hypertension, atrial fibrillation, chronic heart failure, and chronic kidney disease, while male patients suffered more frequently from diabetes mellitus, dyslipidaemia, cerebrovascular disease, and chronic coronary syndrome, and were more likely to smoke. Within hospitalised patients, Makowski et al note that females represent the minority (43% vs.

57%; p<0.001). Writing in the European Heart Journal, Makowski and colleagues report that, during index hospitalisation, women underwent less frequent diagnostic angiographies (67% vs. 70%) and revascularisation procedures (61% vs. 65%; both p<0.001). Furthermore, they reveal that women received guideline-recommended drugs like statins and antithrombotic therapy

In contrast to randomised trials, observational studies, and registries, the studied health claims data are not subject to selection bias by the sponsor or implementer.”

WIfI score does not predict successful healing after transmetatarsal amputation, study finds A higher initial Wound, Ischemia, and foot Infection (WIfI) classification score at initial presentation in chronic limbthreatening ischemia (CLTI) patients who underwent a transmetatarsal amputation (TMA) was not associated with a major amputation down the road, according to a retrospective review of 55 TMAs performed at the University of Washington (UW) in Seattle, USA. A RESEARCH TEAM AT THE INSTITUTION sought to establish whether the Society for Vascular Surgery (SVS) lower-extremity threatened limb risk stratification system could predict successful healing following TMAs, ultimately determining it does not— with the data showing this included both the wound and ischaemia score on presentation as well as after revascularisation.

less frequently at baseline—35% vs. “In contrast to randomised trials, 43% and 48% vs. 53%, respectively observational studies, and registries, (both p<0.001). the studied health claims data are not “Interestingly,” the authors subject to selection bias by the sponsor underline, “after including age or implementer.” and comorbidities in a Cox In addition, the authors regression analysis, female communicate that followThe researchers sex was associated with up was good, both in analysed 199,953 increased overall survival terms of length and data unselected patients (hazard ratio [HR], 0.95; availability. “Patients were of the AOK Health 95% confidence interval included until 2017 and Insurance Fund [CI], 0.94–0.96) and the follow-up phase was amputation-free survival until 2018, displaying the (HR, 0.84; 95% CI, 0.83–0.85; current care situation under both p<0.001).” current guidelines with a longer In the discussion of their findings, follow-up to nine years. A very low loss Makowski et al weigh up various to follow-up was determined, since the strengths and limitations of their change in the health insurance is rather research, noting in particular that their rare, especially in older age groups.” choice of claims database was a key Moving on to limitations, Makowski strength of the investigation. They et al acknowledge that their analysis explain that the almost 200,000 lower is somewhat hindered by the use of extremity arterial disease patients health claims data, in that there may included in the study were insured by be missing information on factors such the AOK Health Insurance Fund, which as clinical status and parameters, the they note covers almost 32% patients success or failure of interventions, or in Germany. Makowski and colleagues patient compliance. Moreover, they add that the AOK consists of 11 note that the basis for the analysis was independent regional Health Insurance diagnostic codes, which they used Funds, which covers healthcare for validation reasons. “This means nationwide in Germany. However, they non-billable diagnoses were often not highlight that AOK-insured patients present and thus not included in our have a lower socioeconomic status analysis,” Makowski and colleagues and higher migration background detail. Another limitation was that and presence of cardiovascular risk differences depending on biological sex factors, found in all regions compared (e.g. hormone status), socioeconomic, with other health insurances. “These financial, or health educational aspects differences,” they write, “probably could not be included in the analysis. leading to different healthcare supply “[CLTI] should be considered as depending on the regional Health a multi-organ disease with an ever Insurance Fund, can influence the increasing prevalence and a poor data but demonstrate a nationwide prognosis,” the investigators posit healthcare supply in a heterogeneous in their conclusion. They stress that patient population”. CLTI patients “do not receive optimal The researchers also point to the therapy,” and that this is “more study design as another strength. prominent in females”.

The study findings were revealed during the Society for Clinical Vascular Surgery (SCVS) annual symposium (19–23 March, Las Vegas, USA). Despite the core conclusion, presenting author Jake Hemingway, a vascular surgery resident at UW, told delegates: “We found that excellent wound healing can still be achieved despite very advanced CLTI and, thus, we should not use the WIfI stage alone to try and preclude patients from attempts at limb salvage. There still is a need for further investigation into how we can monitor our patients after undergoing a TMA to know when further work needs to be done to maintain that wound.” The 51 patients included in the study saw a 12-month major amputation rate of 33%—12 carried out below the knee, and six above. Hemingway said the data demonstrated that an unsuccessful TMA was down to primary failure in 10 patients, “in which they simply never were able to heal their wound, Jake Hemingway delivers WIfI research at SCVS 2022

as opposed to secondary failure, which was wound breakdown remote from their initial TMA.” Four patients saw TMA failure due to infection, developing either necrotising infection or wet gangrene during their initial healing process, he added. “When we looked at the factors that were actually associated with major amputation, we found that none of the following were: either a higher initial WIfI stage wound or ischaemia score at the initial presentation; or whether patients had improvement following revascularisation—this was also not associated; neither was the ischaemia score postrevascularisation,” Hemingway said. Hemingway revealed during questions after his presentation that the UW research team is set to enter a new phase of the study to look at other noninvasive, nonpressure-based measures such as pedal acceleration times in order to establish the most predictive system for successful healing after a TMA.

We should not use the WIfI stage alone to try and preclude patients from attempts at limb salvage.”

Issue 94 | June 2022

AI in Aortic Interventions 13

AORTIC

Artificial intelligence could make endovascular aortic repair outcomes more predictable At the 2022 Charing Cross (CX) International Symposium (26–28 April, London, UK), Cydar Medical founder Tom Carrell delivered a Podium 1st presentation titled ‘Making endovascular aortic repair outcomes more predictable: Artificial intelligence takes on a 20-year-old challenge’. “GIVEN ANY INDIVIDUAL PATIENT WITH some anatomic complexity, do we really know— particularly with the ever-expanding range of treatment options— what is going to be the outcome for them?” According to Carrell, this is the key question at the centre of the 20-year-old challenge the speaker referred to in the title of his talk. Twenty years ago, he detailed, the pioneers of endovascular surgery recognised that anatomic severity was a major determinant of outcomes and therefore probably required reporting standards. “A scoring system would need to strike a balance between having enough granular detail to be useful and also being simple enough to be usable in everyday practice,” he said. A scoring system was built, with the expectation being that subsequent clinical investigations to test the system would be used to modify it. In the 20 years since then, Carrell highlighted that a number of papers on the anatomic severity grade scoring system have been published, showing that it does indeed predict outcomes and complications. However, “there has not been quite so much progress in terms of using that data to modify the schemes,” Carrell pointed out. The speaker noted that there are probably a number of reasons for this, one being that “some of the things that go into the scoring schemes turn out to be rather complicated”. For example, he said, measuring infrarenal neck angulation is “really contentious,” with “very high intraobserver variability”. “Can artificial intelligence (AI) offer both that detail and simplicity?” Carrell asked, highlighting a key question in 2022. He explained that Cydar Medical is developing an extended capability to operate with what the company calls Intelligent Maps.

Tom Carrell at CX

“The concept is that when you plan a case, you are being informed by the outcomes of previous patients with similar anatomy and disease,” he explained. The company’s current product, which is used for planning, guiding, and reviewing endovascular surgery, uses “virtual guidewires”. Carrell elaborated: “We use [virtual guidewires] for planning, but the main function is to identify where you are going to be operating, so that your planning is rendered in the form of a map and overlaid on a live fluoroscopy. As your real guidewires deform the anatomy, the

Cancer patients face greater risks from abdominal aortic aneurysm repair Elective abdominal aortic aneurysm (AAA) repair in patients with a cancer diagnosis is associated with several poor postoperative outcomes according to a study from the University of Missouri School of Medicine (Columbia, USA). “DUE TO THE STRONG association between AAA and cancer, we wanted to determine whether cancer patients who underwent elective AAA repair had a greater risk of in-hospital death, cardiac complications, infection and respiratory problems compared to patients without a cancer diagnosis,” said senior author Jonathan Bath. Bath’s team analysed data from the Cerner Health Facts database. Out of 8,663 patients who underwent AAA procedures, 270 were identified with a

cancer diagnosis. The researchers found patients with cancer who underwent AAA were associated with a hospital

virtual guidewires deform the map so that you have an overlay that reflects the real-time anatomy.” Carrell provided some details on where the software is headed: “What we are doing with Intelligent Maps is taking that capability with the virtual guidewires and the AI that we have in the system and the data from all the thousands of patients who have been treated with Cydar EV Maps and building tools to analyse anatomy.” He added that these tools are a combination of deterministic algorithms using the virtual wires and also using simulated neural networks, or deep learning, to not just segment the vessels, but also to label the aorta and the iliacs according to what branches are coming off at each level. “For each patient, you bring these things together so that you have your geometry, but you have it in the context of where you are right the way along the aorta and the iliac system. This is highly deterministic, so you put the CT scan in and these measures come out, put the same CT scan in or a similar CT scan in and you get the same things coming out.” One of Carrell’s key takeaway messages was that this software has relevance for helping inform decision-making. “You take one patient that produces the analytics and then we use it to match to other patients in the database already, patients who have similar anatomy. It is literally as simple as entering in the CT scan and finding those matching patients. We can then find out what treatment those patients had, what type of approach they had.” Next, Cydar will be working on bringing in the “final steps” of the technology—the outcome metrics for the surgical strategy that was used. “We want to close that 20-year ambition to have the feedback loop in there to modify the scoring system,” Carrell concluded.

The concept is that when you plan a case, you are being informed by the outcomes of previous patients with similar anatomy and disease.”

stay longer than 10 days, renal failure, respiratory problems and infection. “We did not find that a cancer diagnosis increased the risk of in-hospital mortality, cardiac complications or stroke,” Bath said. “But cancer patients did experience more vascular complications such as bleeding, thrombosis or the need to undergo a repeat procedure.” Researchers found male patients with a cancer diagnosis had higher odds of a prolonged length of stay, infection and respiratory failure than women with a cancer diagnosis, but there were far fewer women in the sample, making this finding less robust.

“Cancer diagnosis had no effect on mortality at 30 and 90 days unless the patient had lung cancer,” Bath said. “The mortality rate at the end of the study period was significantly higher in patients with a diagnosis of cancer than not, but many cancers will ultimately lead to patient death despite treatment. These findings illustrate the importance of careful patient selection when determining the need and type of aneurysm repair.” The study, “Outcomes of elective abdominal aortic aneurysm repair in the setting of malignancy,” was recently published by the Journal of Vascular Surgery.

These findings illustrate the importance of careful patient selection when determining the need and type of aneurysm repair.”

Issue 94 | June 2022

Advertorial 15

THIS ADVERTORIAL IS SPONSORED BY SHAPE MEMORY MEDICAL

“Promising technology”: An interventional radiologist’s perspective on the benefits of shape memory polymer embolisation

rely on the fact that, on follow-up, we will see these plugs are actually occluding vessels.” With the Shape Memory technology, “we do get acute occlusions,” Holden communicates, “so we are confident that we will not see recanalisation”. On the aneurysm side, Holden advises starting out on aneurysms with big blood volumes and large aortic side branches—the cases that are “most concerning”. Holden details that the shape memory polymer has performed well in aneursym sac filling trial cases in Smart Polymer is a new shape memory polymer technology, available to endovascular his practice. “We have had cases where patients have specialists, that is incorporated into the Impede embolisation plug family (Shape had large aortic side branches and to date we have Memory Medical). Andrew Holden, an interventional radiologist at Auckland City not had to do side branch embolisation as an ancillary Hospital in Auckland, New Zealand, has been using the product for a number of years procedure,” he recalls. and has been involved in some early studies of the technology. Here, he gives his Taking into account his own clinical experience, perspectives on the unique properties of the polymer, and details how Smart Polymer early data, and planned future studies, Holden devices may be utilised in an interventional radiologist’s practice. expresses a cautious optimism about this emerging technology. “It is being internationally mart Polymer is a porous scaffold polymer with also underlines the fact that, in peripheral recognised that while endovascular aneurysm high surface area. “What that means,” Holden applications, Shape Memory technology has repair (EVAR) is certainly minimally invasive, tells Vascular News, “is that blood works its way a localisation coil to prevent migration it has left us with significant problems. It is through the scaffold in which long residence times of devices. not the final product. The biggest issues I think promote acute thrombosis, so we see acute thrombosis Holden details that his clinical experience are failure to protect patients from aneurysm sac Andrew progression or ongoing growth, but also failure to within the scaffold.” What is more important though, with the technology has been encouraging so Holden he says, is the subsequent healing with mature far. About five years ago, he and colleagues protect them from reintervention. I have believed collagen, followed by resorption of the scaffold. conducted the first-in-human trial with the for a long time that active sac management is “The ability to produce acute thrombosis then vessel Impede plug, and since then they have recorded something that is missing with EVAR, and I think healing and resorption is a really important feature.” accurate deployment, acute thrombosis, and no this technology is very promising. However, I would In addition, Holden highlights the fact that Shape migration with the technology. In addition, they stress that the results, while being positive in our Memory polymer technology can be used to fill blood report having seen no evidence of recanalisation first-in-human trials, are very early results, and we spaces without chronic outward force. “At body on follow-up imaging. “Our experience to date has do need to see a larger body of results and bigger temperature, the Shape Memory polymer expands to left us feeling positive about the Impede’s role as an studies. Fortunately, those are being planned, so that its premanufactured and uncrimped shape, but with a embolic,” Holden remarks. Holden adds that, in the is very exciting.” low chronic output force,” he explains. last 12 months, he has been involved in the AAAAccording to Holden, there are a number of SHAPE first-in-human study, using the Impede device Disclaimers: Andrew Holden is a consultant to Shape Memory Medical and principal investigator of the AAA-SHAPE_NZ trial. features that differentiate Shape Memory polymer as an aneurysm sac filling technology to promote sac Future device applications, prospective studies involving investigational devices, and investigational uses of approved devices are discussed technology from other embolisation devices. “A regression and prevent endoleaks and reintervention. in this interview. The content contains information about AAA-SHAPE, lot of embolisation devices, be they coils or plugs, Considering the main indications for the Shape Shape Memory Medical’s prospective investigational studies of the Impede-FX embolisation plug and the Impede-FX RapidFill when used for do not produce acute occlusion. We may look to Memory polymer, Holden summarises: “Accurate prophylactic abdominal aortic aneurysm (AAA) sac filling during elective occlude a vessel, but find on follow-up that it remains deployment, conformability, acute occlusion, and a endovascular aneurysm repair (EVAR). For more information about the AAA-SHAPE Studies, please visit https:// patent, and that is one of the things we looked at very lack of recanalisation—all of those features mean clinicaltrials.gov/ct2/home carefully in the first-in-human application for this that this technology lends itself ideally as a peripheral NCT04227054 and NCT04751578 Not all devices discussed in this interview are available in all regions. device in peripheral vessels.” vascular embolic device, as well as its obvious In countries recognising CE marking, the Impede Embolisation Plug, the Impede-FX embolisation plug, and Impede-FX RapidFill are indicated to Turning to the issue of landing zones for devices, interesting aneurysm sac filling application.” obstruct or reduce the rate of blood flow in the peripheral vasculature. Holden points out that the Shape Memory polymer Holden believes that an ideal first case in the In the USA, the Impede embolisation plug is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature and the stands out in this arena: “If, for example, a vessel is peripheral vessels could be an aortic branch artery Impede-FX embolisation plug is indicated for use with the Impede irregular or tapers, in some of the devices, landing embolisation. “Although we can put standard plugs embolisation plug to obstruct or reduce the rate of blood flow in the peripheral vasculature. is difficult, but Shape Memory by its ability to in these vessels, we know that we see an incidence The Impede-FX RapidFill device is not approved for sale in the USA. conform to the vessel is obviously well suited.” He of recanalisation or incomplete occlusion, and we

Figure 1. Smart Polymer vascular plug devices. (a) The expanded form of the Impede-FX embolisation plug with Smart Polymer and a proximal radiopaque marker. (b) The Impede embolisation plug with a distal anchor coil deployed in a vessel. (c) An Impede-FX embolisation plug deployed behind the Impede embolisation plug to increase the amount of embolic material in a vessel, with minimal additional metal. (d) The Impede embolisation plug family of devices are pushable. The Impede-FX RapidFill device consists of five Impede-FX 12mm embolisation plugs preloaded in a cartridge.

Figure 2. (a) The expanded form of the Impede-FX embolisation plug with Smart Polymer and a proximal radiopaque marker. (b) The Smart Polymer pore sizes in the Impede-FX embolisation plug family of devices are approximately ~1000–2000 microns. (c) The expanded porous matrix is haemostatic and supports rapid formation of organised thrombus throughout its structure. (d) The porous Smart Polymer matrix self-expands and conforms to the surrounding anatomy. If appropriately sized, an Impede-FX embolisation plug will expand to fill the vessel diameter. Over time, the Smart Polymer stimulates thrombus remodelling and healthy tissue formation, and the polymer gradually bioabsorbs. (e) Histology of a porcine artery implanted with the Impede embolisation plug Smart Polymer device at 60 days post implantation, illustrating uniform extracellular matrix and collagen formation throughout the vessel diameter.

Figure 3. Completion angiography of an AAA-SHAPE case after implantation of Impede-FX embolisation plugs equating to an expanded SMP device volume of 106mL (arrows show the location of select radiopaque markers).

Issue 94 | June 2022

Journal Highlights 17

AORTIC

Less frequent post-EVAR surveillance might be safe in some patient groups, study suggests Results from the multicentre, retrospective ODYSSEUS study carried out in The Netherlands suggest that less frequent surveillance after endovascular aneurysm repair (EVAR) may be warranted. However, authors Anna C M Geraedts (Amsterdam University Medical Centres, Amsterdam, The Netherlands) and colleagues stress that future studies are needed to determine the patient groups in which this would be safe.

he study, recently published in the European Journal of Vascular and Endovascular Surgery (EJVES), highlighted the fact that discontinued imaging surveillance post-EVAR is common in The Netherlands. It also shows that discontinued yearly follow-up in patients with initial postoperative computed tomography angiogram (CTA) without abnormalities is not associated with poor outcomes. “EVAR has become the predominant modality for the treatment of infrarenal abdominal aortic aneurysms (AAA) in The Netherlands,” the authors write, adding that lifelong surveillance is recommended following the procedure. However, they also note that there are concerns regarding the long-term durability of EVAR, lifelong follow-up

routines, and adherence to surveillance programmes. This study, therefore, aimed to examine the association between adherence to postoperative surveillance and survival and secondary interventions in patients with an initial postoperative CTA without abnormalities. Between 2007 and 2012, all consecutive patients undergoing EVAR for intact AAA in 16 hospitals were identified retrospectively, the authors write, noting that patients were followed up until December 2018. Geraedts et al specify that patients were included if the initial postoperative CTA showed no type I–III endoleak, kinking, infection, or limb occlusion. Primary outcomes were aneurysm-related mortality and secondary interventions, and secondary

F/BEVAR review reveals less than 20% of patients suffered intraoperative adverse event A retrospective evaluation of 600 fenestrated or branched endovascular aneurysm repairs (F/BEVARs) for the treatment of complex aneurysms revealed that fewer than one in five patients experienced an intraoperative adverse event, according to a press release announcing study results published in the Journal of Vascular Surgery. THORACOABDOMINAL AORTIC ANEURYSM repair is among the most complex and serious operations in the realm of surgery, the press release notes. Endovascular repair of these aneurysms is now established as a viable alternative to open surgical repair, and, according to the principal author, Gustavo Oderich (University of Texas Health Science Center, Houston, USA) “studies have demonstrated superior results to open repair.” However, despite many technical improvements in complex endovascular repairs, the procedure remains

outcome was all-cause mortality. Of the 1,596 patients included in the study, the authors report that cumulative aneurysm-related, overall, and intervention-free survival was 99.4/94.8/96.1%, 98.5/72.9/85.9%, and 96.3/45.4/71.1% at one, five, and 10 years, respectively. They note that American Society of Anesthesiologists (ASA) classification (ASA IV hazard ratio [HR], 3.810; 95% confidence interval [CI], 1.296–11.198), increase in AAA diameter (HR, 3.299; 95% CI, 1.408–7.729), and continued followup (HR, 3.611; 95% CI, 1.780–7.323) were independently associated with aneurysm-related mortality. The same variables and age (HR, 1.063

Future prospective studies are indicated to determine in which patient groups follow-up can be safely reduced.” per year; 95% CI, 1.052–1.074) were significantly associated with all-cause mortality, the authors add. In terms of secondary interventions, Geraedts and colleagues relay that no differences were observed between patients with continued versus

discontinued follow-up (89/552; 15% vs. 136/1,044; 13%; p=0.091). Writing in EJVES, the authors acknowledge various limitations of their study, including its retrospective, observational study design. This carries a risk of information bias, they state, noting for example that “it was unclear if patients were lost to follow-up, if imaging studies had been discontinued after uncomplicated surveillance, or if patients had undergone imaging surveillance elsewhere”. Furthermore, they recognise that the inclusion of patients until only 2012 limits the ability to draw conclusions from more recent devices, there were no clear protocols as to when a patient might be discharged from further follow-up, there was missing information on cause of death, and also the fact that reasons why patients were no longer under surveillance were not noted. Despite these limitations, Geraedts et al also highlight some notable strengths of the research such as the use of population-based data with long-term follow-up and the accuracy of verifying deaths through the National Death Register. In addition, they note that the investigation comprises all imaging studies made following EVAR, and “thus provides a complete overview of national practice and adherence to the ESVS [European Society for Vascular Surgery] guidelines”. Geraedts and colleagues stress that “future prospective studies are indicated to determine in which patient groups follow-up can be safely reduced”.

technically demanding with significant risks. “Data on the incidence of intraoperative Technical failures may indeed result in adverse events during F/BEVAR and disastrous complications such as loss of a the clinical sequelae have not been kidney, bowel or spinal ischaemia.” previously described in detail,” said As reported in the March 2022 edition Oderich. “This large single-centre study of the Journal of Vascular Surgery, showed that intraoperative adverse events the aim of this study was to review the were present in 18% of patients who incidence of intraoperative adverse events underwent this procedure, two-thirds of and the impact on outcomes of F/BEVAR whom required additional procedures to The authors for the treatment of complex reported on 600 treat the complications. aortic aneurysms. “Endovascular technology continues consecutive The authors reported on 600 consecutive to evolve. Novel devices have added repairs performed repairs performed at the Mayo Clinic at the Mayo Clinic preloaded systems, lower-profile fabric, between 2007 and 2019. The overall 30between 2007 and steerable catheters and sheaths to day mortality was 2% and there were 122 minimise procedural difficulty.” The study and 2019 intraoperative adverse events, defined as also underscores the need not only for any intraoperative complication or technical problem careful treatment planning but also for operators to requiring an additional or unplanned procedure have an armamentarium of skillsets and devices to among 105 patients (18%). The most frequent events address these intraoperative adverse events. included 55 target arteries, 46 access, and seven graft complications. Although intraoperative adverse events did not affect patient survival (odds ratio of 1), suggesting the intraoperative rescue manoeuvres were successful, there were more major adverse events in the intraoperative adverse event group, mostly due to acute kidney injury (27% vs. 11%, p<0.001). Risk factors for the intraoperative adverse events included female sex (odds ratio 2.5), presence of target artery stenosis (odds ratio 2), and Crawford Extent II aneurysm (odds ratio 1.9).

600

Gustavo Oderich

Endovascular technology continues to evolve. Novel devices have added preloaded systems, lower-profile fabric, and steerable catheters and sheaths to minimise procedural difficulty.”

June 2022 | Issue 94

18 Interview

PROFILE

Alexander Zimmermann Alexander Zimmermann (University Hospital Zurich, Zurich, Switzerland) tells Vascular News about his career to date, beginning with a rotation in vascular surgery that opened up “a whole new world of medicine” to his directorship of the Department of Vascular Surgery at the University of Zurich. He outlines his current research interests, anticipates how the field might develop in the next decade, and recalls his most memorable case—the first physician-modified fenestrated endovascular aneurysm repair (FEVAR) procedure he ever performed.

During my childhood, it was always my wish to become an astronaut. This later led to the idea of studying aerospace engineering. However, since I was deployed in the medical service of the German Armed Forces during my compulsory military service after school, I got to know the variety and fulfillment of the medical profession. This is how my enthusiasm for medicine developed, which consequently led to the decision to study medicine instead of aerospace engineering. From the beginning, however, it was clear to me that I wanted to pursue a surgical specialty. This was originally plastic surgery since here one could immediately see the results of one’s manual work. During my residency in plastic surgery, there was a rotation into vascular surgery. Here, a whole new world of medicine suddenly opened up for me. Endovascular therapy, which was still in its infancy at the time, combined with the possibility of open surgical therapy and the higher meaning of the subject, captivated me from the beginning. This led to a change in my career aspirations and the continuation of my specialist training in vascular surgery. A coincidence that I have never regretted to this day.

Who have been your career mentors?

Mentor is a figure from Greek mythology. He stood by Odysseus in word and deed and always gave him courage in difficult situations. Unfortunately, I only had a mentor at the beginning of my clinical career in visceral surgery in Professor Ulrich Fink, who took care of me in word and deed. In the further course of my training, I was unfortunately not granted this good fortune again. This experience gave me the deep desire to be able to act as a mentor for the junior staff working in my department. Whether I succeed in this, however, is a matter for other people to judge. Nevertheless, some people have had a lasting influence on my path. In the field of surgery in general, this was Professor Jörg Rüdiger Siewert. His visionary thinking and high level of organisation were very impressive. In vascular medicine, Stéphan Haulon, Tim Resch, and Eric Verhoeven are inspiring personalities for me.

What has been the most important development in vascular surgery during your career?

I started my clinical career in early 2000 when endovascular aortic therapy began to be available nationwide in major vascular surgery centres. The development of this form of therapy still leaves me speechless today. Whereas in the early 2000s conventional EVAR was still considered a complex endovascular aortic procedure, these procedures are now performed percutaneously and on an outpatient basis. In this context, I have been particularly fascinated by two developments: first, the development of off-the-shelf thoracoabdominal stent grafts, which are immediately available to patients in urgent cases

and emergencies, thereby providing access to therapy to a much larger patient population due to the fact they are far less invasive. In this context, I would also like to mention physician-modified stent grafts, as these continue to inspire me with their variability in application.

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

So-called endovascular aortic sealing (EVAS). When this technique came on the market, I was initially very excited. The clarity of the logic of lining the perfused portion of the aneurysm through a polymeric sac seemed so simple and promising to me that I wondered why no one had come up with this idea before. In my initial enthusiasm, I thought that this would eliminate the problem of endoleaks. I am convinced that the combination of soft thrombus and rigid embolisation material, unfortunately, cannot form a stable unit and therefore is also the problem in embolisation of type II endoleaks in aneurysm sacs with thrombus.

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

Technical advancements in the field of open surgical and endovascular medicine will only be marginal in the future. Here, it is still possible to achieve better postoperative results by improving technical skills and materials. Nevertheless, I think the real developments

Through capabilities like artificial intelligence, we will be able to make more accurate predictions about risk stratification.” will be in other areas. Through capabilities like artificial intelligence, we will be able to make more accurate predictions about risk stratification. Prevention will also play an important role, as the expanding costs of increasingly complex therapies will not be covered by healthcare systems in the future. Also, the possibility of locally applied drugs for aortic aneurysms, as already successfully practised with the drug-eluting balloon technique in peripheral arteries, will fundamentally change the way we treat this disease.

What are the biggest challenges currently facing vascular surgery?

In the treatment of aortic aneurysm, I still see a big problem in the correct indication. If you imagine that nowadays, despite the technical possibilities, only the

alisonlang.com

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

maximum diameter is used as a parameter for the evaluation of a therapy indication, this seems almost grotesque. Another important point for me is to make endovascular therapy more durable. Despite the almost inflationary use of endovascular therapy in the area of peripheral arteries and the aorta, we have not yet been able to achieve durability comparable to that of open surgical therapy. On the one hand, this poses a problem in the area of increased revision rates and the associated socioeconomic costs. Secondly, this has of course a negative impact on the training of the next generation of vascular surgeons. Since simpler pathologies are nowadays almost exclusively treated by endovascular means, these procedures are missing during open surgical training. The open surgeries still performed today are mostly for highly complex cases that cannot serve as training cases.

Issue 94 | June 2022

Interview 19

What are your current areas of research? Currently, I am working on two main scientific topics. One question that concerns me is what defines the success of endovascular therapy. Why is there a shrinkage of the aneurysm sac in one patient and not in the other, although both have similar morphological preconditions? There are so many aspects that can influence this that I will probably never run out of work and questions. Another focus is aortic dissection. We are currently focusing on the baroreceptors in the aortic arch to gain a better understanding of the blood pressure dysregulation in this disease.

What do you think has been the most important paper published in the last year? “‘First-in-man’ total percutaneous aortic arch repair with three-inner-branch endografts: a report of two cases” by Stéphan Haulon et al. Even though this is only a case report, the article shows very clearly how far the specialty of vascular surgery has developed and emancipated itself from cardiac surgery.

What has been your most memorable case?

I can remember in detail my first physician-modified FEVAR. This was a multimorbid patient with a contained ruptured mycotic thoracoabdominal aortic aneurysm. I fabricated a two-fold fenestrated and two-fold branched stent graft and was able to implant it without difficulty. The fact that I was able to fabricate a custom-made device within one hour, which often takes companies several weeks, and thus offer a patient this minimally invasive therapy option in an emergency, still excites me today.

What advice would you give to someone looking to start a career in medicine? Medicine is and will remain an exciting and thrilling profession. In recent years, we have seen a decline in the importance of surgical procedures in favour of drug-based or minimally invasive therapies. As a result, entirely different talents will be required of future physicians. It is always important to remain interested and to consider early on which path your career should take. In addition, you should join a team that supports you in your personal development.

What are your hobbies and interests outside of medicine?

I enjoy spending my remaining time with my family and exploring new cities and countries with them. Currently, I share my eight-year-old son Maxi’s enthusiasm for the ancient Romans and follow their footsteps with him. Otherwise, I love to run in the mountains, especially around Chamonix, as the physical exertion and the grandeur of nature teach you the humility necessary to be successful in our profession. And last but not least, I still feel connected to my Bavarian roots in many ways.

Current academic and staff appointments

Director of the Department of Vascular Surgery, University Hospital Zurich, Zurich, Switzerland Chair of the Department of “Surgical Specialities”, University of Zurich, Zurich, Switzerland Chair of Vascular Surgery, University of Zurich, Zurich, Switzerland

Society memberships

Swiss Society for Vascular Surgery Germany Society for Surgery German Society for Vascular Surgery European Society for Vascular Surgery Germany Society of Mountain and Expedition Medicine American College of Surgeons Swiss College of Surgeons

Education and training (selected)

July 2005–March 2008: Resident at the Department of Vascular Surgery, Klinium rechts der Isar, Technical University of Munich (TUM), Munich, Germany August 2000: Resident at the Department of Surgery, Klinikum rechts der Isar, TUM, Munich, Germany 1999: Medical School at TUM, Munich, Germany 1993–1999: Medical School at Ludwig Maximilian University of Munich, Munich, Germany

Issue 94 | June 2022

Advertorial 21

THIS ADVERTORIAL IS SPONSORED BY BENTLEY

Early results and expert experience positive for the BeYond dedicated venous stent Launched in July 2020, the BeYond Venous self-expanding stent system (Bentley InnoMed GmbH) now has early clinical data and expert experience to support its use in venous interventions. In what Michael Lichtenberg (Arnsberg Vascular Center, Arnsberg, Germany) describes as the “emerging” field of venous interventions, BeYond provides physicians with a strong stent option, offering in particular the best balance of the key attributes of high radial force, flexibility, and crush resistance.

What is your early experience with the BeYond Venous stent?

At the Arnsberg Vascular Center, we have been using this stent for around one and a half years now. I would say I have gotten very used to this stent over the last few months, and I think it is a very good stent in terms of radial force, crush resistance, and flexibility. Based on our data, I can confidently say that this stent works well in the iliacs, and gives a very good answer to the stress which is present in the iliacs. From a clinical perspective, I believe the BeYond device is a very good stent option.

n this interview with Vascular News, Lichtenberg outlines his early experience with BeYond, shares some newly released interim results with the device, and outlines what is next for this dedicated venous stent.

Could you give a brief overview of the field of venous interventions? Which patients are treated and why?

The venous field is certainly an emerging one. More and more patients with acute and chronic deep venous disease—including those with acute iliofemoral deep vein thrombosis (DVT) and chronic DVT, as well as those with May-Thurner syndrome—are being treated. Awareness is definitely rising, and not only on the patient side, but also on the physician side, which has meant that intervention numbers have increased over the last few years. I believe this trend will continue, as increasing numbers of patients are now referred for venous interventions.

What is the role of dedicated venous stents?

I think all specialists in the field align on the point that we need dedicated venous stents for treatment of acute and iliofemoral DVT because they have certain features, such as high radial force and flexibility, which uncovered, self-expandable arterial stents do not have. Without these attributes, stents may be crushed and may occlude very quickly, leading to disaster in terms of reocclusion, restenosis, and probably another DVT.

this cohort analysis really proves the efficacy and safety of the stent. We included patients with nonthrombotic iliac vein lesions (NIVLs) and postthrombotic syndrome (PTS), so it is a mixed cohort, a real-world cohort, with all the challenges we face in patients with acute and chronic disease.

How do you anticipate the BeYond stent might perform in the long term?

This is of course a little bit speculative, as there are many factors that influence long-term behaviour and effects of a venous stent, but I am feeling very positive about the results so far. We have not seen any significant problems yet, but we will have to wait for the two-year follow-up report, which we will hopefully get very soon.

If a colleague were to ask you about the BeYond venous stent, how would you describe it in three phrases?

The really positive aspects, besides excellent crush resistance and flexibility, are accurate and safe deployment, effective treatment, and good clinical data.

What is next for the BeYond stent?

We are currently working on two-year and also threeyear follow-up data. We should have the two-year data in the second half of the year maybe in November or December, and of course three-year data in 2023.

This stent is a very good compromise in terms of radial force on the one hand and flexibility on the other.” Is there one main advantage that you think makes the BeYond stent stand out in the venous stent market? One feature that really stands out of that you can use the stent proximally, so it can go through the common iliac vein to the common femoral vein, thanks to the device’s radial force and flexible characteristics. To date, we have not experienced any issues with restenosis in either the common femoral vein or the distal external iliac vein, which is really positive. We have experienced this issue with other stents, and so it would seem that this stent is a very good compromise in terms of radial force on the one hand and flexibility on the other.

Figure 1a

You recently conducted a retrospective analysis of 59 patients. What are the key takeaway messages from this analysis?

This cohort includes patients who were treated in our clinic over the last 18 months. We usually see patients on a regular basis after stent implantation, and so we have very good follow-up data. At 12 months, we have follow-up data for half of the patients. We only had four significant incidences of restenosis, which is a good chronic patency rate if you compare the data with those from other studies. Therefore, I must say that from a clinical standpoint Michael Lichtenberg

Figure 1B Forty-two-year-old female patient with postthrombotic syndrome after iliofemoral DVT 10 years before on the left side. Chronic occlusion of the iliac vein (Figure 1a). After recanalisation with a 14x150mm BeYond Venous stent (Figure 1b).

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Thromboaspiration: More options for pulmonary embolism

April 2022 | Issue 85

page 8

CAVA RCT delivers powerful evidence Embolization supporting use of PORTs tocomes supply systemic knocking chemotherapy

Cryoablation: Freezing out lumpectomy

Profile: Laura Crocetti page 18

European Society of Medical Oncology these devices enabling prompt placement (ESMO nor the American Society of and removal by nurse-led teams, local Clinical Oncology (ASCO) make specific availability of devices, technical issues recommendations regarding the type of such as the avoidance of the vital device to be used. structures in the neck, and perceived CAVA showed that PORTs were lower up-front costs—but there is a associated with a reduction in sketchy evidence base behind this uptick, complication rate of about 50% when the authors say. “PORTs, by contrast, are compared to a PICC line, and the most expensive and least when compared with the frequently used of the three Hickman line. “There was a devices,” Moss emphasises. fairly strong preference for On stemming the tide of PORTs, amongst both the PICC use, the lead author patients receiving them and also continues: “Changing policy In the trial, radioembolization (also the healthcare staff who look institutions like the For most patients receiving systemic anticancer treatment (SACT), called selective in internal radiation after them. These were basically NHS is never easy. There totally implanted ports (PORTs) are more effective and safer than therapy [SIRT] or sometimes felt to be better devices and the will be all sorts of reasons both Hickman-type tunnelled catheters (Hickman) and peripherally transarterial radioembolization only downside is the cost and why people inserted central catheters (PICCs). The CAVA trial’s results, [TARE]) using glass beadsdo not want to Jonathan G whether these services are set change—with costs being recently published online in The Lancet, recommend reshaping (TheraSphere; Boston Scientific) Moss up and geared to deliver these one and who is going to be current guidelines and practice, so that most patients requiring containing radioactive yttrium-90 devices compared to the other in the PORTs [being chemotherapy for solid tumours receive a PORT within the UK (Y-90) was used putting as a secondtwo in a timely manner,” Moss added.line treatment another], and quickly they can be National Health Service (NHS), foreshadowing a pivot in practice in how combination put in. […]of There aresystemic lots of nurse teams that might be “slow to start with”. with standard care at the moment have been trained Resetting UK practice maychemotherapy forwho patients who hadto place PICC lines. We need toorbeafter able to “The bottom line is, for a solid cancer, he CAVA (Central venous not be a brisk business disease progression during sell chemotherapy. the message to them that we are not if you are going to need intravenous access devices for the delivery With the exception of five patients in first-line saying they should not provide a service chemotherapy for three months or of systemic anticancer therapy) the PORT group who received a general for patients, but trying THEREFORE, to persuade them more, you should be offered the trial is a National Institute for Health anaesthetic, all devices were inserted THE EPOCH TRIALISTS, put inona different device. I think we Researchopen-label, under local anaesthetic. set theirtosights determining the impact A wealth(NIHR-) of datafunded emerging in the option of a PORT. We should try and need to try andand move away from doctors empower patients so that that this will multicentre, randomised controlled triala Moss outlines that decision-makingof radioembolization second-line last 18 months, including from putting in in patients the PORTs nurses putting be something they think will be best for that compared complication rates and processes behind the choice of devicechemotherapy withand colorectal liver small multicentre, randomised, in the PICC lines. These are all fairly them,” Jonathan G Moss (Institute of costs of the three devices usedoftogenicular deliver are “poorly understood” globally. metastases who progressed on oxaliplatinsham-controlled study straightforward procedures to place, anticancer drugs via a central vein. pain Cardiovascular and Medical Sciences, Eye-catchingly, PICC use has been or irinotecan-based first-line therapy. artery embolization for knee and I have prospective great confidence Glasgow, UK), chief investigator, tells Reported to to be osteoarthritis, the largest randomised captured to be buoyant. “PICC usage The has international, phasethat 3 we can secondary brings in nursingtrial teams to place all three Interventional News on the subject of trial to date to compare all threeofdevices, increased over the past decade and is now EPOCHempower pivotal clinical randomised 428 its slipstream a glimpse other similar increased PORT take-up. CAVA set outinvasive to establish acceptability, the dominant strategy in many westernpatients.devices, but particularly PORTs.” minimally options to Moss thatwere the The paucity of good evidence clinical and cost-effectiveness of the European countries and the USA.” Findings fromacknowledges the trial, which treat disability in the entire comparing central venous access devices for patients receiving SACT This spike in PICC popularity may bepresented at the European Society for Medical musculoskeletal system. At one month, Disability devices (CVADs) entails that neither the for three months, or more. underpinned the ease of insertion of Oncology (ESMO) congress (16–21 September Continued on page 2 embolization improvementbywas 2021) and published in the Journal of Clinical mbolization, which is rapidly surfacing significantly also significantly reduced pain more greater in the Oncology, showed that the addition of SIRT as a safe and effective procedure for the than the sham treatment group met both itsON primary including HE treatment of patients with osteoarthritis COMMENTING THE endpoints, MAIN BENEFITS treatment did (p=0.02) survival (PFS) hepatic of the knee, has been shown to be technically foreseesprogression-free as a result of being granted this and recognition, (p<0.01) progression-free survival (hPFS)will of patients achievable, with very promising outcomes at early Brown says: “The IASIOS accreditation allow with colorectal cancer to (mCRC) of follow-up. It is thought to bring down pain by reducing our centre to metastatic promote our high standards patients, The administrators. trial did not show synovial arterial hypervascularity. referrersthe andliver. hospital Thesignificant process of procedures for interventional radiologists in the near future in overallallowed survival patients A multicentre, randomised, single-blinded, shamseeking improvement IASIOS accreditation usoftothe review and and make a substantial impact in the lives of millions of criticallyinappraise the SIRTour arm. controlled study published online ahead of print in October existing practices, and to ensure patients. The data from our study demonstrate that that how we The addition of TheraSphere treatment 2021 in the Journal of Vascular and Interventional work is aligned with the international the effect of embolization in reducing pain and standard.significantly both PFS (p=0.0013) Radiology (JVIR) showed that, in patients with The promiseincreased of accreditation provided us with improving function is far greater than the effect the motivation and hPFS (p<0.0001). Patients SIRT mild-to-moderate knee osteoarthritis, embolization to examine every facet ofreceiving our practice, of a sham procedure or placebo. This study will including with second-line were to 31% less results in symptomatic improvement greater than areas where wechemotherapy needed to improve comply be useful in convincing potential referrers as with thelikely to show disease progression or death the sham procedure did, with clinically significant IASIOS requirements.” well as insurance companies that this procedure (hazard ratio [HR]=0.69) and 41% less likely to reduction in pain and disability (as measured by should bedirector part of theat osteoarthritic knee pain hepatic disease progression or death vs. the Visual Analogue Score [VAS] and Western Ten centres have achieved the International Brown (clinical I-MED, The Continuedshow on page 4 algorithm. What is most exciting is that with chemotherapy alone (HR=0.59). Median Ontario and McMaster Universities Osteoarthritis Accreditation System for Interventional Wesley treatment Hospital, Queensland, Australia) this procedure justitbe the first of many overall survival was 14 and 14.4 months Index [WOMAC]). In the 21-patient all Oncology Services (IASIOS)study, accreditation, on this achievement andmay how certifies embolization procedures (p=0.7229). There were 68.4% grade 3 adverse those assigned to the group failed a benchmark ofsham quality standard and that this hospitaldifferent is providing the highest that will be oncology utilised to treat events reported after radioembolization as toassurance, show significant improvements at since 2018. I-MED Radiology, standards of interventional (IO)pain throughout the musculoskeletal compared with 49.3% in those who received one month and crossed over to the just achieved The Wesley Hospital, has care. “Personally, I am convinced that system,” Ari J Isaacson, adjunct chemotherapy alone. Both groups received the treatment arm. this recognition to become the first clinic IASIOS will bring game-changing renewal faculty at theradiology University of North “Genicular artery embolization has to do so. in the Southern Hemisphere and evolution to interventional the potential to be one of thespeaks most to Nicholas Continued on page 2 Interventional News practice around the world,” he says. Ari J Isaacson commonly performed embolization Continued on page 4

EPOCH trial reignites radioembolization as treatment for colorectal liver metastases

on knee pain’s door

p<0.01 p=0.02

EWesley hospital

becomes first in Australia to achieve IASIOS accreditation in historic global milestone for CIRSE

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Issue 94 | June 2022

CX 2022 Highlights 23

VENOUS

Contemporary venous intervention reduces post-thrombotic syndrome in initial CLEAR-DVT analysis In an initial cohort of patients enrolled in the CLEAR-DVT study, contemporary venous intervention resulted in an open vein, which reduced post-thrombotic syndrome (PTS). This is the main concluding finding of a Podium 1st presentation delivered by Mitchell Silver (OhioHealth Heart and Vascular, Columbus, USA) at the 2022 Charing Cross (CX) International Symposium (26–28 April, London, UK).

ilver began by noting that residual venous obstruction is an independent predictor of adverse events, including recurrent venous thromboembolism (VTE), PTS, and venous stent failure. In a summary of the literature on this topic, Silver underlined the ATTRACT trial, noting in particular its limitations. This trial enrolled patients from 2009 and 2014 at over 56 sites. He highlighted the fact that only 1/50 patients screened were actually randomised and that only 57% of patients had iliofemoral DVT. In addition, Silver pointed out that the investigators used standard venography and not intravascular ultrasound (IVUS), median tissue plasminogen activator (tPA) duration was 21 hours, no dedicated venous stents were used; and only 20% of patients had venous duplex at one year. “Treatment, patient selection, and technology have evolved,” Silver remarked. The ATTRACT trial showed that a thrombus-free common femoral vein at one month was associated with improved 24-month clinical outcomes, including PTS, moderate-or-severe PTS, and quality of life (QoL), the speaker communicated. He also relayed

that, in patients presenting with common femoral vein thrombus, successful restoration of full common femoral vein compressibility during the first month was associated with reduced PTS and improved QoL, and possibly also with reduced moderate-or -severe PTS.

Treatment, patient selection, and technology have evolved [since ATTRACT].” Moving on to CLEAR-DVT, Silver explained that phase one of the study assessed an initial cohort of patients. This first phase represents a proof-ofprinciple study aiming to validate the hypothesis that contemporary catheter-directed therapy done by experienced operators has significant efficacy and safety. In addition, it seeks to provide objective evidence to move forward with a larger multicentre, prospective

Overtreatment in venous disease: Financial incentives are “the elephant in the room” To combat the “overtreatment problem” in the appropriate care of venous disease, “a concerted, complex, multimodal effort” is required from specialists across disparate parts of the world. THAT WAS THE CONCLUSION delivered by Manjit Gohel (Cambridge University Hospitals, Cambridge, UK) during the opening day Venous & Lymphatic Challenges session— Appropriate Care Challenges—at CX 2022, further telling attendees: “But the elephant in the room is reimbursement. Until that is sorted,” he said, “we will not be able to get on top of this.” During his presentation, “How to curtail inappropriate care in venous disease interventions,” Gohel had stressed how the aim was to curb overtreatment but also not to reduce innovation. “Probably the most inappropriate care in venous disease is actually undertreatment. We have masses of undiagnosed, and definitely undertreated, venous problems. Overtreatment is however an enormous problem.” Why? Education plays a part, he said, along with such elements as patients’ desire for intervention and an evidence

Armando Mansilha and Manjit Gohel

gap in some areas of care that “allows variations in practice.” Yet, the biggest is financial gain, Gohel outlined. “Reimbursement systems around the world are poorly incentivised,” he said. Earlier in the session, Steve Elias (Englewood Health Network, Englewood, USA) spoke on the extent of overtreatment in superficial venous disease care, stating how evidence demonstrated such overtreatment clearly represented inappropriate care. Responding to a question posed by Armando Mansilha (University of Porto, Porto, Portugal), a session

randomised controlled versus real-world evidence study. The investigators enrolled patients from five US and one European site in this initial, single-arm study, Silver told the CX audience. Baseline scores were assessed at 10 days, 30 days, six months, and 12 months, and the study assessed only iliofemoral DVT, up to 14 days. Silver explained that the team used the 8Fr Angiojet ZelanteDVT catheter (Boston Scientific) with on-the-table lysis, and that there is mandated IVUS on all patients. He added that venous stenting was used for more than 50% cross-sectional area reduction and that the post-procedural anticoagulation regimen was standardised to oral anticoagulation for a minimum of six months and plavis (75mg) for the first 60 days. Silver detailed that 44% of the 35 patients in the pilot cohort were male and that the average age of the cohort was 48 (range: 22–73). Results on the initial 27 patients at 12-month follow-up show that baseline Villalta was 10 (range: 4–19) and that, after treatment, this had been reduced to two. There was no PTS in 96% of patients and mild PTS in the remaining 4%, with no Villalta score greater than five, Silver noted. The speaker concluded that the CLEAR-DVT study showed that contemporary venous intervention resulted in an open vein, which reduced PTS. Considering next steps, he pointed to one-year data on all patients, which will cover the primary endpoint of PTS rates and secondary endpoints of six-minute walk test, and Venous clinical severity score (VCSS) and QoL scores. Silver also noted that the team are in discussion with industry regarding RCT versus real-world evidence studies on the topics of iliofemoral DVT, new thrombectomy devices, mandated IVUS, and dedicated venous stents.

moderator, about how aspects of the overtreatment problem might be addressed, Elias offered one potential solution: “Stop paying people for doing the wrong thing by partnering with payors,” he said. Elias had referenced outliers in practice who may perform many more ablations per patient than the 1.8 shown in a Medicare data analysis from 2019. “Because the payors know what claims are being sent in. Let us start with those who were two standard deviations away from the norm,” Elias added. These interventionists may be doing the right thing, or perhaps they are seeing patients with more advanced disease, but such a move to partner with payors would represent a move in the right direction, he explained.

We need to make sure we have the right doctors doing the procedure with appropriate skills, judgement and ethics.” Kathleen Gibson

Mitchell Silver

Kathleen Gibson (Lake Washington Vascular Surgeons, Bellevue, USA) turned the spotlight on deep venous disease, speaking on “managing the safe introduction of medical devices”, focused particularly on the developing area of dedicated venous stents. “When these were approved, it was kind of like taking people who were used to driving a stick shift [car],” Gibson said, making an analogy to hithertofore use of the non-dedicated Wallstent. “Now we have got a fleet of automatics.” Everyone could now drive more easily, she said, except the dawn of dedicated venous stents “led to some disasters.” She also pondered what venous disease specialists can do differently. “We need to make sure we have the right doctors doing the procedure with appropriate skills, judgement and ethics,” Gibson said. That means “correct patient selection in terms of diagnosis and application of technology, and short- and long-term follow-up”, along with increased rigour of venous training, discouraging inappropriate use, and publishing complications. Elsewhere in the session, Marianne De Maeseneer (Erasmus Medical Centre, Rotterdam, The Netherlands) spoke on the value of recently published European Society for Vascular Surgery (ESVS) guidelines on chronic venous disease in the promotion of evidence-based care.

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Issue 94 | June 2022

Launch Pad 25

Launch Pad

We must rid healthcare of bullying, one small but brave act at a time Claire Dawkins, a vascular trainee in the North East of England, discusses the issue of bullying in the healthcare setting. She focuses in particular on bullying within vascular surgery, outlining UK survey results that suggest the issue is worsening in the field, and suggesting some ways the profession as a whole can tackle the problem. During a seminar with junior medical students regarding potential barriers to their learning, when discussing issues in the medical setting, problems with the environment and the patient were volunteered by the students. But when

the situation was changed to a surgical setting, issues with the surgeon and their personality were highlighted. Whether this view is realistic or unfair it shows that there is a lot to be done to change a reputation that seems to be entrenched so deeply. The Rouleaux Society surveyed UK trainees regarding their experience of bullying, undermining and harassment (BUH). Despite work undertaken by the Vascular Society and the Royal Colleges, the results of BUH had worsened from 2017 to 2021. But is it actually worsening? Is awareness improving? Or are individuals becoming more sensitive? Everyone agrees that bullying is a bad thing. It is an awful experience for the victim, sometimes with long-term consequences, particularly to self-esteem and confidence. It can have significant impact on the team and patients, on occasion affecting patient safety. But often the perpetrator is not actually aware they are being a bully. With the increased frequency of trainee rotations and working for a group of consultants rather than an individual, it is impossible to know your team members in the same way as you traditionally could. It is easy to forget that a joke to one person may be offensive and undermining to another.

VENOUS

Study finds increased risk of serious blood clots up to six months after COVID-19 A study from Sweden published by The BMJ recently finds an increased risk of deep vein thrombosis (DVT) up to three months after COVID-19 infection, pulmonary embolism (PE) up to six months, and a bleeding event up to two months. THE FINDINGS ALSO SHOW A higher risk of events in patients with underlying conditions (comorbidities), patients with more severe COVID-19, and during the first pandemic wave compared with the second and third waves. The researchers say these results support measures to prevent thrombotic events (thromboprophylaxis), especially for high-risk patients, and strengthen the importance of vaccination against COVID-19. It is well known that COVID-19 increases the risk of venous thromboembolism (VTE), the authors write. However, they note that less evidence exists on the length of time this risk is increased, if risk changed during the pandemic waves, and whether COVID-19 also increases the risk of major bleeding. To address these uncertainties, the researchers set out to measure the risk of DVT, PE, and bleeding after COVID-19. Using national registries in Sweden, they identified more than one million people with confirmed SARSCoV-2 infection between 1 February 2020 and 25 May 2021, matched by age, sex,

and county of residence to more than four million people who had not had a positive SARS-CoV-2 test result. They then performed two analyses: in the first, they calculated the rates of DVT, PE, and bleeding in COVID-19 individuals during a control period (before and long after COVID-19 diagnosis) and compared it to the rates in different time intervals after COVID-19 diagnosis (days 1–7, 8–14, 15–30, 31–60, 61–90, and 91–180). In the second analysis, they calculated the rates of DVT, PE, and bleeding during the period 1–30 days after COVID-19 diagnosis in the COVID-19 group and compared them to the corresponding rates in the control group.

So how do we tackle the problem? There is no quick fix. Education and development of self-awareness are key, as well as understanding individual differences. Ignorance is no defence, nor is a perceived ‘lack of resilience’ an excuse to overstep boundaries. Fostering a culture of speaking up, either as a victim or an observer, would give those ‘unintentional bullies’ the awareness of their behaviour. But the delivery of these interventions is complex and not isolated to those senior surgeons the medical students had stereotyped. Bullies come from all levels and backgrounds. I once defended one of my juniors to a bully, but shamefully was not brave enough to call the bully out for her behaviour, or escalate it for fear of the repercussions. Small actions can lead to big changes. So I ask for your bravery. Stand up for each other. Remembering the ‘bully’ will have their own difficulties and insecurities. What we walk past is what we accept. We must rid healthcare of bullying, one small but brave act at a time.

The results show that compared with the control period, risks were significantly increased 90 days after COVID-19 for DVT, 180 days for PE, and 60 days for bleeding. After taking account of a range of potentially influential factors, the researchers found a fivefold increase in risk of DVT, a 33-fold increase in risk of PE, and an almost twofold increase in risk of bleeding in the 30 days after infection. In absolute terms, this means that a first DVT occurred in 401 patients with COVID-19 (absolute risk 0.04%) and 267 control patients (absolute risk 0.01%). A first PE event occurred in 1,761 patients with COVID-19 (absolute risk 0.17%) and 171 control patients (absolute risk 0.004%), and a first bleeding event occurred in 1,002 patients with COVID-19 (absolute risk 0.10%) and 1,292 control patients (absolute risk 0.04%). Risks were highest in patients with more severe COVID-19 and during the first pandemic wave compared with the second and third waves, which the researchers say could be explained by improvements in treatment and vaccine coverage in older patients after the first wave. Even among mild, non-hospitalised

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.

COVID-19 patients, the researchers found increased risks of DVT and PE. No increased risk of bleeding was found in mild cases, but a noticeable increase was observed in more severe cases. This is an observational study, so the researchers cannot establish cause, and they acknowledge several limitations which might have affected their findings. For example, VTE may have been underdiagnosed in patients with COVID-19, testing for COVID-19 was limited, especially during the first pandemic wave, and information on vaccination was not available. However, results were largely consistent after further analyses, and are in line with similar studies on the association between COVID-19 and thromboembolic events, suggesting that they withstand scrutiny. As such, the researchers say their findings suggest that COVID-19 is an independent risk factor for DVT, PE, and bleeding, and that the risk of these outcomes is increased for three, six, and two months after COVID-19, respectively. “Our findings arguably support thromboprophylaxis to avoid thrombotic events, especially for high-risk patients, and strengthen the importance of vaccination against COVID-19,” they conclude.

[This study] reminds us of the need to remain vigilant to the complications associated with even mild SARS-CoV-2 infection, including thromboembolism.”

June 2022 | Issue 94

26 CX 2022 Highlights

IN.PACT AV Access: Three-year data support use of paclitaxel-coated balloon as “standard of care” in fistula maintenance

reinterventions to maintain TLPP being patients from the United States Renal required through 36 months in the DCB Data System (USRDS) through three group versus 324 in the PTA group. years is higher than in both groups, Holden then moved on to detail at 41.9%. 36-month access circuit primary patency Before concluding, Holden also (ACPP) rates—stating that a “similar referred to differences between these trend” was observed here, with a rate recent data from IN.PACT AV Access of 26.4% in the DCB group and 16.6% and those seen in the Lutonix AV in the PTA group. He IDE study (BD), which labelled this difference demonstrated TLPP rates as being “significant” of 26.9% and 24.4% Holden relayed too, and noted a similar in its DCB and PTA reduction (20.7%) in the groups, respectively, a TLPP rate of number of reinterventions upon concluding after 24 required to maintain ACPP months. Due to its latest within the DCB group. timepoint being at two Some 311 reinterventions years, Holden noted that it The 36-month results from the IN.PACT AV Access study were necessary in the is difficult to draw direct (Medtronic)—which were presented for the first time at the DCB group, compared to comparisons between this 2022 Charing Cross (CX) International Symposium (26–28 April, 392 in the PTA group. study and IN.PACT AV London, UK)—indicate that end-stage kidney disease (ESKD) After briefly alluding Access—but stated that, in the DCB group, patients treated with the IN.PACT AV drug-coated balloon (DCB; to mortality-related safety having shown a sustained compared to Medtronic) remained intervention-free for longer than those who concerns that have been and superior performance received a standard percutaneous transluminal angioplasty (PTA). raised regarding paclitaxel with DCB versus PTA, in the past, the speaker the latter is now “the ndrew Holden (Auckland to inhibit neointimal hyperplasia and reported an incidence only randomised pivotal City Hospital, Auckland, New treat this leading cause of arteriovenous of all-cause mortality— trial of a device treating Zealand) reported these findings fistula (AVF) stenosis in ESKD patients. following a vital status dysfunctional AVFs to to CX attendees during a Podium 1st The trial is comparing use of IN.PACT update—that did not demonstrate consistent presentation in the Vascular Access AV in a DCB group to standard PTA in a represent a statistically and sustained clinical Masterclass session. He noted that a control group, and initially enrolled 330 significant difference benefit through in the PTA “significant difference” in target-lesion patients with a de novo or non-stented between the two 36 months”. group, through primary patency (TLPP) between the restenotic native fistula, undergoing treatment groups. Summarising these study’s DCB and PTA treatment groups haemodialysis. He noted an 36 months data, he said that ESKD was seen through the three-year followBuilding on positive results seen at all-cause patients in IN.PACT AV up timepoint, maintaining the trend previous timepoints in this prospective, Access had a median time observed in the 24-month IN.PACT AV single-blinded, randomised IDE study, to reintervention that was Access data, which Holden delivered Holden relayed a TLPP rate of 43.1% mortality rate of 26.6% 14.7 months longer when they were virtually at last year’s CX Symposium. in the DCB group, compared to 28.6% in the DCB group and treated with DCB compared to PTA. This investigational device exemption in the PTA group, through 36 months. 30.8% in the PTA group, and As such, Holden added, these findings (IDE) study is seeking to assess He also reported that a 21.3% highlighted the fact that the mortality represent durable long-term data the safety and effectiveness of the reduction in reinterventions rate among “all-comer” haemodialysis supporting the use of the IN.PACT AV IN.PACT AV DCB, which delivers was associated with DCB as “a standard of care” for AVF IN.PACT AV the antiproliferative drug paclitaxel DCB use, with 255 maintenance in this patient population.

43.1% 28.6%

New sirolimus data provide encouragement despite “potentially disappointing” efficacy results

added that—while the results are “potentially disappointing”—this is a small, exploratory study and alluded to possible confounding factors within these findings. “We do need longer-term data and randomised controlled studies […] if we are Tjun going to move forward seriously within this Tang The results of a small-scale pilot study from Asia have indicated “potentially field, and with this technology,” Tang concluded. disappointing” results with a novel drug-eluting balloon in treating dysfunctional And, speaking to Vascular News, Tang noted the arteriovenous access for dialysis. These findings were delivered by Tjun Tang importance of being careful when interpreting the (Singapore General Hospital, Singapore)—who also highlighted “excellent” technical results of an exploratory pilot study—especially one and clinical success rates and positive safety outcomes—via a Podium 1st that was designed to power a randomised controlled presentation during the CX 2022 Vascular Access Masterclass. trial, as this one has been. “I do not think it is actually a setback at all,” he TANG PRESENTED 12-MONTH RESULTS Moving on to 12-month data from the trial, Tang continued. “In fact, I think it is very encouraging. I from the ISABELLA (Intervention with Selution reported a target-lesion primary patency (TLPP) rate think the fact we are not getting any serious adverse SLR agent balloon for endovascular latent limus of 44% (16/36 lesions) and a circuit access patency events with the balloon […] is reassuring.” therapy for failing AV fistulas) trial, which assessed rate of 31% (10/32 lesions), which represented Tang also told Vascular News that, with the the utility of the Selution SLR sirolimus-eluting decreases from 72% and 63%, respectively, at six exception of the IN.PACT AV Access study balloon (MedAlliance) for minimising the effect of months. In addition, he stated that the overall rate (Medtronic), a similar drop-off in patency rates neointimal hyperplasia and treating arteriovenous of secondary patency—defined as freedom from between six and 12 months had been observed in fistula (AVF) stenosis. access circuit abandonment—was 94.1% (32/34 several previous studies using paclitaxel to treat The speaker noted that ISABELLA had a patients) at 12 months compared to the 97.2% (35/36 dysfunctional dialysis access. recruitment target of 40 patients, with 34 of these patients) observed at six months. “In conclusion, the patients (85%) ultimately being evaluated at the ISABELLA study showed excellent technical and 12-month follow-up timepoint in November 2021. clinical success rates [100%],” Tang said. He also detailed that the majority of these patients He also relayed that the use of Selution SLR in had either radiocephalic or brachiocephalic fistulas patients with AVF stenosis appears safe, with no with recurrent lesions requiring treatment—and the serious adverse events, such as pulmonary embolism most common indication for intervening was a drop in or bronchopneumonia, being associated with its access flow, observed in 61.5% of cases. use in the study. And, in terms of efficacy, Tang

I do not think it is actually a setback at all. In fact, I think it is very encouraging.”

Issue 94 | June 2022

Carotid Interventions 29

CAROTID

Carotid stenting demonstrates comparable short- and long-term results to endarterectomy POOLED PATIENT-LEVEL DATA FROM patients with ≥70% asymptomatic carotid stenosis, more than 2,500 asymptomatic, non-octogenarian who were randomised to receive CAS or CEA in subjects have shown that carotid artery stenting (CAS) addition to standard medical therapy, were included achieved comparable short- and long-term results in their study. to carotid endarterectomy (CEA). The findings of This was based on data from two large, randomised this analysis have been published by Jon Matsumura trials. One of these enrolled 1,091 patients (548 CAS; (University of Wisconsin, Madison, 543 CEA) and the other enrolled 1,453 USA) and colleagues in the Journal of asymptomatic patients who were less than Vascular Surgery (JVS). 80 years of age (1,089 CAS; 364 CEA). The study authors begin by detailing that Independent neurologic assessment and asymptomatic carotid stenosis is the most routine cardiac enzyme screening was frequent indication for CEA in the USA. performed, the authors detail. Published trials and guidelines support The prespecified, primary composite CEA indications in selected patients with endpoint of their study was any stroke, longer projected survival and in instances Jon Matsumura myocardial infarction or death during the where periprocedural complications are periprocedural period, or ipsilateral stroke low, they note, while transfemoral CAS with embolic within four years after randomisation. protection is a newer treatment option. The authors report their results, stating that there With this in mind, they set out to compare outcomes was “no significant difference” in the primary in asymptomatic, non-octogenarian patients treated endpoint between CAS and CEA (5.3% vs. 5.1%; with CAS, versus those treated with CEA, via a hazard ratio=1.02; 95% confidence interval, 0.7– widescale analysis of patient-level data. 1.5; p=0.91). In terms of the periprocedural rates for Matsumura and colleagues report that a total of 2,544 each component part of this composite endpoint, they

CX audience as-yet unconvinced by data supporting transcarotid artery revascularisation Audience polling in the 2022 Charing Cross (CX) International Symposium (26–28 April, London, UK) Acute Stroke session revealed scepticism regarding the benefits of transcarotid artery revascularisation (TCAR) in the treatment of symptomatic carotid artery stenosis. This followed a debate that saw Michael Stoner (University of Rochester Medical Center, Rochester, USA) and Gert J de Borst (University Medical Centre Utrecht, Utrecht, The Netherlands) go head-to-head over the quality of evidence supporting TCAR as compared to carotid endarterectomy (CEA) and carotid artery stenting (CAS).

toner presented first, arguing in favour of the motion that “TCAR is a safe and effective alternative to transfemoral CAS or CEA in the treatment of patients with symptomatic internal carotid artery stenosis”. He stated that TCAR has “significant advantages” in patients with appropriate anatomies—on the basis that two prospective, single-arm trials have supported its application in symptomatic carotid stenoses and high-risk asymptomatic stenoses, while large, prospectively acquired registry data have demonstrated its improved safety profile versus transfemoral carotid stenting too. The riposte to this was then provided by de Borst, who claimed that, while current evidence in favour of TCAR is “promising”, welldesigned, independent, investigatordriven studies that compare this prophylactic procedure to CEA in recently symptomatic patients are necessary in establishing its true value.

When pressed by Stoner regarding the specific evidence required to confirm the benefits of TCAR, de Borst said randomised controlled trials (RCTs)— or at least prospective registry data— may achieve this but, for now, CEA and CAS remain the more provably safe treatment approaches. The majority of the CX audience was ultimately swayed by this argument, with 79% voting against the motion. The same session saw carotid artery stenosis in focus once again, with a debate entitled: “Treatment of

Michael Stoner and Gert J de Borst

also detail the following: Any stroke: 2.7% with CAS and 1.5% with CEA (p=0.07) Myocardial infarction: 0.6% with CAS and 1.7% with CEA (p=0.01) Death: 0.1% with CAS and 0.2% with CEA (p=0.62) Any stroke or death: 2.7% with CAS and 1.6% with CEA (p=0.07) They go on to note that, after this period, the rates of ipsilateral stroke were “similar” between the two groups (2.3% with CAS vs. 2.2% with CEA; p=0.97). This led Matsumura and colleagues to conclude that, in a pooled analysis of two large, randomised trials of CAS and CEA in asymptomatic, nonoctogenarian patients, CAS ultimately achieved comparable short- and long-term results to CEA. Speaking to Vascular News following publication of these data in JVS, Matsumura said: “The impact of this large study is that it uses the best available evidence—prospective, randomised controls, intention-to-treat analysis, federal regulatory oversight, independent neurologic exams and biochemical screening. “In addition, it studies the largest population (asymptomatic, non-octogenarian patients) with severe carotid stenosis receiving interventional treatment in the USA. “It has direct relevance for patient care, treatment guidelines and payor policy. It is also highly congruent with the recently published international trial, ACST-2.”

asymptomatic internal carotid artery audience polling revealed that 60% stenosis should only be performed of those in attendance, and tuning when there is a risk of periprocedural in remotely, were unconvinced by 30-day stroke and a death rate of 2% this viewpoint and disagreed with or less”. CX attendees ultimately the motion. voted against this motion— indicating Following this, the Acute Stoke their agreement with Alison Halliday Challenges session—moderated by (University of Oxford, Oxford, UK). Hugh Markus (University of Cambridge, Halliday’s argument centred around Cambridge, UK) and Barbara Rantner the fact the notion that treatment (Ludwig Maximilians University ‘should only be performed’ in these Munich, Munich, Germany)—closed cases distorts the risk from registries with discussions of key existing data on and trials that produce a range of the treatment of carotid artery stenosis. periprocedural outcomes. Halliday Firstly, Dominic Howard (University went on to assert that restricting of Oxford, Oxford, United Kingdom) intervention to very low-risk groups presented a population-based cohort may reduce periprocedural risk to study, systematic review, and metarates of 1–2%, but this is also analysis, on the risk of stroke less likely to prevent useful in relation to degree numbers of future of asymptomatic TCAR is a safe strokes, because carotid stenosis. and effective alternative to ‘high-risk’ groups Summarising transfemoral CAS or CEA in the may be denied these findings, treatment of patients with symptomatic intervention. he reported that internal carotid artery stenosis The debate stroke risk was also saw Hanshighly dependent Henning Eckstein on the degree (Technical of stenosis, University of suggesting benefit For Against Munich, Munich, of CEA might Germany) present be underestimated his argument in favour of in patients with the motion. He told audiences severe stenosis, while at the Acute Stroke Challenges five-year stroke risk was low for session that registry data, RCTs and patients with moderate stenosis on observational studies show a constant contemporary medical treatment— decline in the 30-day stroke and death calling into question any benefit from risk of CEA for asymptomatic carotid revascularisation. stenosis over the years. As such, Maarit Venermo (Helsinki University Eckstein concluded, a 30-day stroke Hospital, Helsinki, Finland) followed and death risk of 2% or less is realistic, this with a presentation centred around and should therefore be the target for the “huge” international variation in the all vascular surgery units. However, daily practice of carotid surgery.

21% 79%

June 2022 | Issue 94

30 Market Watch

Clinical News Restorative Axess graft demonstrates promising patency and safety in first-inhuman study

The preliminary results from a clinical trial assessing a restorative haemodialysis access graft have shown promising early puncturing, patency and safety data. These findings from an ongoing first-in-human study of the Axess graft (Xeltis) were presented for the first time by trial investigator Matteo Tozzi (University of Insubria, Varese, Italy) at the Charing Cross Symposium (CX 2022; 26–28 April, London, UK and virtual). Axess is a synthetic, biocompatible blood vessel, which, overtime, is colonised by the patient’s own tissue following implantation and becomes a living vessel via the process of endogenous tissue restoration. To date, it has been implanted in 11 end-stage kidney disease patients, with a median follow-up time of 6.5 months, across five European sites as part of the Axess study. Overall, more than 600 dialysis sessions have been enabled in this patient group, with puncturing—or dialysis initiation—starting as early as two weeks after implantation in some patients. Preliminary data analysis shows “very promising outcomes” on primary endpoints, according to a Xeltis press release. The current data show 100% rates of functional patency and safety, with no aneurysms or infections reported, and “excellent ease-of-use” for surgeons and dialysis nurses, the release adds. “Our first clinical experience using the Axess device is extremely encouraging. This fully synthetic graft is easy to implant, can be promptly punctured and exhibits an excellent safety profile,” said Tozzi. “Its potential to turn into a longer-lasting natural vessel is an additional benefit and suggests that an optimal solution for dialysis patients may be within our reach.” “At a time when fistulas are being challenged as a first-line treatment in a number of dialysis patients, the first ever clinical data for Axess are particularly significant, and aligned with its remarkable and unprecedented positive results from preclinical trials, showing its full endothelialisation,” said Frans Moll (University Medical Center Utrecht, Utrecht, The Netherlands), who will present data on preclinical developments with Axess at CX 2022. “The early outcomes from our Axess trial are very promising, so we have decided to expedite the development of this revolutionary restorative device with an international pivotal trial, starting this year, with the aim to reach patients who need haemodialysis as soon as possible,” said Xeltis CEO Eliane Schutte.

First patient enrolled in iliCo study of iCover stent

iVascular has announced the initiation of its first trial with the new generation covered stent iCover—the iliCo study. The study has the objective of evaluating the safety and effectiveness of iCover for the treatment of de novo aorto-iliac atherosclerotic lesions in patients with symptomatic arteriopathy of the lower limbs. The first iliCo patient was enrolled by Elias Noory (University Heart Center, Bad Krozingen, Germany), part of the team of the co-primary investigator of the study, Thomas Zeller (University Heart Center, Bad Krozingen, Germany). The case was transmitted live at the 2022 Charing Cross (CX) Symposium (26–28 April, London, UK).

Presentation of the iliCo live case at CX 2022

The case presented by Noory was a patient with an occlusion in the right common and external iliac artery. Three iCovers were implanted successfully, achieving an excellent flow after the procedure. The iliCo study is a prospective, multicentre, non-randomised, singlearm observational study led by coinvestigators Zeller and Bahaa Nasr (CHU Brest, Brest, France). The study will evaluate the efficacy and the safety of the iVascular iCover covered stent for the treatment of de novo aortoiliac atherosclerotic lesions in 214 patients with symptomatic arteriopathy of the lower limbs across 18 sites in Germany, France, Belgium, and Spain. Patients will be followed up for up to two years. The primary endpoint of the study is primary patency at 12 months. Secondary endpoints include 30-day complications, major amputation at target limb, target lesion revascularisation (TLR), target vessel revascularisation (TVR), and quality of life. ICover received the CE mark on March 2021 and has demonstrated in different cases its unique visibility, conformability, and safety during the procedure, iVascular said in a press release. “We are excited and honoured to participate in the trial and enrol the first patient of the iliCo trial,” said Zeller. “From our own experience, iCover facilitates the iliac arteries treatment with its radiopaque markers, flexibility, and excellent balloon crimping.”

“The start of iliCo study represents an exciting milestone as iCover is an advancement of aorto-iliac lesions treatment,” added Nasr. The iliCo live case and all CX broadcast sessions can be watched on demand by registrants.

Alucent Biomedical announces first patient enrolled in first-in-human natural vascular scaffolding clinical trial

Alucent Biomedical announced in a press release that it has enrolled the first patient in ACTIVATE II, an Australia-based first-in-human clinical trial to evaluate the safety and efficacy of its natural vascular scaffolding (AlucentNVS) technology. The therapy is designed to open vessels and maintain patency without the use of permanent implants for the treatment of peripheral artery disease (PAD) of the lower extremities. The AlucentNVS vessel restoration system with photoactivated linking combines standard angioplasty with linking of the structural proteins in the wall of a blood vessel. The intervention is designed to deliver restoration of the vessel’s lumen and sustained improvement of blood flow, without the introduction of a foreign implant, such as a metallic stent. AlucentNVS photoactivated linking is also designed to mitigate the well-known adverse effects of angioplasty, such as vessel recoil. Sustained, improved blood flow is expected to result in pain relief, limb preservation, and an improved quality of life for patients. The first patient in the ACTIVATE II study was enrolled by Chris Delaney at Flinders Medical Centre in Adelaide, Australia. In total, the trial will enrol up to 50 subjects at up to 12 research sites, which will include Prince of Wales Hospital in Sydney, The Alfred Hospital in Melbourne, Royal Perth Hospital, and Sir Charles Gairdner Hospital in Perth. The primary endpoints of the study are freedom from composite investigational-device, procedure-related major adverse events, primary patency as assessed by Doppler ultrasound, and freedom from clinically driven target lesion revascularisation (CD-TLR) at one year. ACTIVATE II follows the completion of enrolment for the ACTIVATE I safety study of AlucentNVS in the USA. Preclinical testing of AlucentNVS in animal studies has shown acute and long-term safety and patency without the proinflammatory and mechanical risks of placing a rigid foreign implant into the blood vessel. “PAD is a difficult condition affecting so many people worldwide, and its current treatments have significant shortcomings,” said Myles Greenberg, Alucent Biomedical’s CEO. “We want to change that by offering a whole new way to treat these patients with AlucentNVS. Alucent’s novel approach has the potential to change the way PAD is managed in the future.”

ACC.22: Three-year data show “durable blood pressure reductions” through renal denervation

Long-term data from the first 80 patients in the SPYRAL HTN-ON MED trial have been presented during a featured clinical research session at the American College of Cardiology’s annual scientific sessions (ACC.22, 2–4 April, Washington DC, USA). The data, which have been simultaneously published in The Lancet, “underscore confidence” in renal denervation (RDN) as a treatment for hypertension, according to Medtronic, the sponsor of the study. In the first 80 patients of the SPYRAL HTN-ON MED trial, the data demonstrated that patients who were prescribed anti-hypertensive medications and treated with the Symplicity Spyral (Medtronic) RDN system continued to show durable, clinically significant blood pressure reductions through three years. The results demonstrated an 18.7mmHg reduction in RDN patients versus 8.6mmHg in sham for 24-hour systolic ambulatory blood pressure (ABP), as well as a 20.9mmHg reduction in RDN patients versus 12.5mmHg in the sham arm for office systolic blood pressure (OSBP). “Across the latest trials, consistent blood pressure reductions have been observed in patients with uncontrolled hypertension treated with the Medtronic Symplicity Spyral RDN system,” said Felix Mahfoud (Saarland University Hospital, Homburg, Germany) and member of the SPYRAL HTN executive committee. “For the first time, we now have randomised data that demonstrate that in a typical

Symplicity Spyral catheter

patient population—hypertension patients who are on anti-hypertensive medications and treated with RDN— we are seeing the continued, longterm blood pressure lowering effect. Lowering blood pressure can have meaningful clinical results for patients, including a decrease in the risk of cardiovascular events.” The trial also demonstrated procedural and long-term safety with the Symplicity Spyral RDN catheter, with zero major device or procedural safety events through three years. “With the ON MED randomised data presented and published today, Medtronic has now demonstrated the long-term benefit of renal denervation against a backdrop of an

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Market Watch 31

Clinical News anti-hypertensive medication, with continued demonstration of a safe procedure,” said Jeffrey Popma, chief medical officer for the Coronary & Renal Denervation business and the Structural Heart & Aortic business at Medtronic. “This highlights the importance of additional treatment options such as renal denervation.” Approved for commercial use in more than 60 countries around the world, the Symplicity Spyral RDN system is limited to investigational use in the USA, Japan, and Canada. SPYRAL HTN-ON MED is a global, randomised, sham-controlled trial investigating the blood pressure lowering effect and safety of RDN with the radiofrequency-based Medtronic Symplicity Spyral system in hypertensive patients prescribed one to three anti-hypertensive medications. The long-term ON MED data presented at ACC.22 studied the same cohort of patients as the six-month primary endpoint analysis that was previously published in The Lancet in 2018. Medtronic also announced it recently completed randomisation for the full cohort of its SPYRAL HTN-ON MED trial and closed enrolment. The full analysis cohort targets up to 340 randomised patients. Medtronic expects

the six-month post procedure follow-up for the full cohort will be complete in the second half of 2022. “The data presented at ACC underscore Medtronic’s confidence in RDN as a solution for the millions of people who suffer from uncontrolled high blood pressure. These new data will be important to regulatory officials, clinicians and payers as we look to bring a new treatment option to market for patients with uncontrolled hypertension,” said Jason Weidman, senior vice president and president of the Coronary & Renal Denervation business unit at Medtronic. “Looking ahead, we remain focused on the anticipated six-month follow-up for the full cohort of the ON MED trial in the second half of this calendar year.”

Data from new VOYAGER PAD reinforce benefit of Xarelto plus aspirin in patients with PAD and various comorbidities

The Janssen Pharmaceutical Companies of Johnson & Johnson recently announced data from new analyses from the Phase 3 VOYAGER PAD clinical trial reinforcing the benefit of the Xarelto (rivaroxaban) vascular dose (2.5mg twice daily plus

Xarelto

aspirin 100mg once daily) in reducing severe vascular events in patients with peripheral arterial disease (PAD) after lower-extremity revascularisation (LER), a procedure that restores blood flow to the legs. Data from the two analyses demonstrate the role that the Xarelto vascular dose plays in PAD patients with and without chronic kidney disease and in PAD patients with and without a history of statin therapy. Results were featured at the American College of Cardiology’s 71st Annual Scientific Session (ACC.22; 2–4 April, Washington DC, USA).

Magneto Thrombectomy Solutions announces successful first-in-human results for treatment of pulmonary embolism

Magneto Thrombectomy Solutions recently announced successful first-inhuman (FIH) results showing safety

and feasibility of the eTrieve system, a catheter based on electric fields for removing blood clots, in patients with acute pulmonary embolism (PE). According to a press release, the data showed a significant reduction in right ventricle/left ventricle ratio and alleviation of PE-associated symptoms. “Magneto provides intermediate and high-risk PE patients with a unique solution for safely and effectively removing large clots blocking the arteries in the lungs,” said Piotr Musialek (John Paul II Hospital, Krakow, Poland), an investigator in the study. “The combination of a largediameter ‘vacuum cleaner’ with electromechanical thrombus extraction, allows an immediate resolution of dyspnoea and swift recovery of the cardiorespiratory system.” The prospective, single-arm, multicentre FIH study assessed the initial safety and performance of eTrieve in treating patients with acute PE. The study enrolled 10 participants across three sites in Denmark and Poland. Results show that the procedure, performed under light sedation only, was safe with no devicerelated complications. The primary performance endpoint was also met, with significant reduction of right ventricle to left ventricle volume 48 hours post-intervention. Significant clot volumes were removed, and alleviation of PE-associated symptoms was demonstrated, the company details.

June 2022 | Issue 94

32 Market Watch

Product News Silk Road Medical announces FDA approval of expanded indications for Enroute transcarotid stent system

Silk Road Medical recently announced that the US Food and Drug Administration (FDA) approved expanded indications for the company’s Enroute stent to include patients at standard risk for adverse events from carotid endarterectomy (CEA). Previously, the stent was approved for use only in patients with anatomic or physiological criteria that put them at high risk of complications from more invasive surgical procedures. “This is the first time in history that a stent-based approach has demonstrated non-inferiority in stroke and death rates relative to CEA, with our TCAR [transcarotid artery revascularisation] system offering the added benefit of significantly reduced cranial nerve injury risk,” said Erica Rogers, president and chief executive officer of Silk Road Medical. “This label expansion levels a playing field once dominated by open surgical techniques, allowing an expanded number of patients and physicians access to the benefits of a less invasive treatment option.” Silk Road Medical had previously submitted a premarket approval (PMA) supplement, which included data extracted from the Vascular Quality Initiative. The surveillance data included in the submission represented real-world outcomes in 20,264 patients considered at standard surgical risk. According to a company press release, those data demonstrated that use of Silk Road Medical’s TCAR system is statistically non-inferior in stroke and death outcomes to CEA, while showing a ninefold reduction in cranial nerve injury (2.7% vs. 0.3%, p<0.001). “Pairing the right patient with the right treatment results in significantly improved physician and patient experiences and outcomes. I speak for the vascular community in welcoming this label expansion for TCAR and recognising this as a vital advancement in the treatment paradigm for patients at risk of stroke,” said Marc L Schermerhorn (Beth Israel Deaconess Medical Center, Boston, USA). “The decision regarding which patients to treat with TCAR is no longer restricted to patients at high surgical risk, providing a greater opportunity for the care team to pursue the less invasive approach for a broader set of their patients. At Beth Israel Deaconess, going forward, we expect that the right treatment for the majority of our atherosclerotic carotid disease patients will be TCAR.”

Terumo Aortic announces US FDA approval for Thoraflex Hybrid device

Terumo Aortic has announced that the US Food and Drug Administration (FDA) has granted approval of the Thoraflex Hybrid frozen elephant trunk (FET) device for commercial sale in the USA for the treatment of patients with complex aortic arch disease. Thoraflex Hybrid is the first-of-itskind device used in FET repair in the USA, according to Terumo Aortic, and was granted Breakthrough Device designation by the FDA in 2021.

Thoraflex Hybrid

Thoraflex Hybrid is a singleuse medical device combining a Gelweave polyester graft with a nitinol self-expanding stent graft, and is indicated for the open surgical repair or replacement of damaged or diseased vessels of the aortic arch and descending aorta with or without involvement of the ascending aorta in cases of aneurysm and/or dissection. Principal investigator Joseph Coselli (Baylor College of Medicine, Houston, USA) commented: “This approval represents a significant milestone in the treatment of patients who need total aortic arch replacement and have significant disease of the descending thoracic aorta. They can now be treated any time in a single-stage procedure with this hybrid device, rather than in two procedures, which has been the conventional pathway in the [USA] for this group of patients. This, in turn, has led to lowering the risk of major adverse events by 22.6%, in the first year, over traditional treatments.” Coselli continued: “Thoraflex Hybrid facilitates secondary interventions for distal extension and, in the USA, is designated for usage with Terumo Aortic’s RelayPro NBS device. This unique labelling aspect provides surgeons with additional confidence should patients have continued aortic disease progression.” Paul Kuznik, president of Terumo Aortic North America, added: “The FDA approval of Thoraflex Hybrid is a tremendous opportunity for Terumo Aortic in the [USA]. This innovative hybrid device complements our

open surgical graft and endovascular portfolio making us one of the strongest medical device companies within the aortic space, helping to deliver our commitment to provide solutions for every aorta.”

Penumbra announces the European launch of the Indigo system with Lightning 7 and Lightning 12 intelligent aspiration

Penumbra has announced that its Indigo aspiration system with Lightning 7 and Lightning 12 have secured CE mark and are now commercially available in Europe. Both technologies are part of Penumbra’s Indigo aspiration system— now with Intelligent Aspiration for mechanical thrombectomy—and are designed for single-session arterial and venous thrombus removal, including the treatment of pulmonary embolisms. “Technology advancements such as Lightning 7 and Lightning 12 are critical to improving patient outcomes and expanding use of mechanical thrombectomy to a broader range of patients,” said Andrew Wigham (John Radcliffe Hospital, Oxford, UK). “Lightning enables us to remove blood clots in the body quickly and efficiently, often in a single session, while also minimising blood loss and potentially reducing the need for thrombolytics and prolonged ICU [intensive care unit] stays.” Powered by the Penumbra Engine, Lightning 7 and Lightning 12 combine the new Indigo system CAT7 and CAT12 aspiration catheters with Lightning intelligent aspiration, a computer-aided clot detection technology that can differentiate between clot and blood. The system is designed to reduce blood loss and the need for clotdissolving drugs, which, Penumbra claims, may lower the risk of bleeding complications. The company states that the Lightning technology also provides an alternative to other surgical options. “CAT7 is a high-power, low-profile catheter that features laser-cut hypotube technology and circumferential sweep designed for dependable delivery and maximal clot extraction,” a press release details. “CAT12 is a large-lumen aspiration catheter that also incorporates novel laser-cut hypotube-based catheter engineering to provide advanced deliverability and torqueability within the body.” “The launch of our Lightning portfolio in Europe will provide a much-needed option for physicians to address debilitating blood clots in the body effectively and efficiently,” said James Benenati, chief medical officer at Penumbra. “We have seen our latest advancements in mechanical thrombectomy reduce blood loss while increasing clot removal efficiency in the USA. These innovations may help improve patient care compared to conventional therapy. We are now

able to help more patients with this technology by expanding access to physicians in Europe.” “Blood clots in the body can be difficult to access and are potentially life-threatening. Until now, treatment options have been limited,” said Joan Kristensen, vice president and head of the Europe, Middle East and Africa region for Penumbra. “The introduction of our Lightning portfolio in Europe will expand access of our most advanced clot removal technology for the body, which combines intelligent aspiration and innovative catheter engineering to remove blood clots in a single session. With Lightning, mechanical aspiration technology continues to advance to meet the needs of patients, which is our core purpose at Penumbra.”

Venovo venous stent returns to US market after 2021 recall

BD recently announced that its Venovo venous stent is back on the US market following a recall last year. In 2019, the company reported that the US Food and Drug Administration (FDA) had granted premarket approval for the Venovo venous stent. In a recall notification dated 12 May 2021, however, BD communicated that the company had expanded a safety notice issued earlier in the year for the Venovo venous stent system to include all sizes and lots within expiry date. The company details that the Venovo venous stent is a flexible nitinol stent specifically designed to reopen blocked iliac and femoral veins in order to maintain adequate blood flow. The stent is designed with a balance of radial strength, compression resistance and flexibility needed for the treatment of symptomatic post-thrombotic and non-thrombotic iliofemoral lesions. Additionally, the broad stent sizing allows clinicians to treat large diameter veins and long lesion lengths. “The unique attributes of the Venovo stent make it particularly well-suited to treat iliofemoral occlusive disease,” says Michael Dake (University of Arizona, Tucson, USA), the principal investigator for the Venovo investigational device exemption (IDE) trial. “Most importantly,” says Dake, “it is purpose-built for application in veins, and engineered to address the special challenges of venous lesions that are very different than those posed by arterial narrowing.” Dake presented positive one- and two- year results of the VERNACULAR trial of the Venovo venous stent at meetings in 2018 and 2019 meetings, respectively.

Shockwave Medical announces global launch of new peripheral IVL catheter

Shockwave Medical has announced the global commercial availability of the Shockwave M5+ peripheral intravascular lithotripsy (IVL) catheter after receiving both CE mark

Issue 94 | June 2022

Market Watch 33

Product News and US Food and Drug Administration (FDA) clearance. A company press release details that the Shockwave M5+ catheter is specifically designed to decrease IVL treatment time, provide alternative access options, and expand IVL therapy to patients with larger vessel sizes. “Shockwave’s new peripheral catheter offers remarkable improvements that enable efficient and effective treatment for some of our most difficult-to-treat patients, some of whom previously could not have been treated with IVL,” said Peter Soukas (Miriam and Rhode Island Hospitals, Providence, USA), one of the first

M5+

physicians to use the new catheter. “While treating patients with long, severely calcified lesions will always be challenging, the new Shockwave catheter is appropriately sized for larger vessels and has been optimised to expand options for facilitating vessel access, all while decreasing the amount of time needed to perform IVL in the procedure.” Shockwave M5+ incorporates valued customer feedback to improve IVL efficiency in tackling complex calcified lesions, including quicker cycle time that delivers two pulses per second, an increased catheter length of 135cm, and a new, larger 8mm size, the company communicates. The catheter is specifically designed to treat otherwise difficultto-treat calcified lesions in the peripheral arterial system of the lower extremities, including the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries. “The launch of Shockwave M5+ is the latest step in our commitment to expanding the applicability of our technology for more diverse patient populations and anatomies,” said Doug Godshall, chief executive officer of Shockwave Medical. “After a very successful limited launch, we are

enthusiastic about the global rollout of Shockwave M5+ and the ability to provide our customers with a new tool to advance treatment options—with the consistent reliability and simplicity of IVL that physicians have come to expect when treating patients with Shockwave IVL.” Shockwave Medical advises that the M5+ catheter is now commercially available in Europe and the USA.

Cook Medical receives FDA Breakthrough Device designation for Zenith Thoraco+ endovascular system

Cook Medical’s Zenith Thoraco+ endovascular system (Thoraco+) has received Breakthrough Device designation from the US Food and Drug Administration (FDA), a press release reports. The company details that, while the

Zenith Thoraco+ graft

product is not commercially available yet, the benefits of the designation include priority review and interactive and timely communication with the FDA during the clinical trial and premarket review phases in order to help get lifesaving devices to patients more quickly. The Thoraco+ is the second product from Cook Medical to receive a Breakthrough Device designation in 2022. “We are excited to receive an FDA Breakthrough Device designation for the Thoaraco+. This will be a great addition to our portfolio of aortic products so we can offer treatments to a wider variety of patients,” said Mark Breedlove, senior vice president of Cook Medical’s Vascular division. Cook communicates that the Thoraco+ is built on the strength of the proven Zenith platform and represents a next-generation endovascular graft for the treatment of thoracoabdominal aortic aneurysms. The system is indicated for the endovascular treatment of patients with thoracoabdominal aortic aneurysms (Crawford classification I–IV). The Thoraco+ is an off-the-shelf device incorporating four side branches for the celiac artery, superior mesenteric artery, left renal artery, and right renal artery. Cook advises that, to accommodate varied patient anatomy, the Thoraco+ will be available in a range of diameters and lengths.

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June 2022 | Issue 94

34 Market Watch

LimFlow raises US$40 million in Series D financing

Industry News Cydar Medical announces strategic collaboration with Medtronic Cydar Medical recently announced it has entered a strategic collaboration with Medtronic. Under the pilot arrangement, Cydar’s EV Maps software will be introduced to up to 40 new global sites, combining Cydar’s augmented intelligence technology with Medtronic’s services and case support, with the goal of improving patient care. The Cydar EV Maps software harnesses the latest in cloud graphics processing unit (GPU) computing, computer vision and machine learning technology to advance surgical visualisation and decision-making in theatre and across the care pathway. This enables clinicians to create detailed, patient-specific 3D maps for procedure planning, image-guided navigation, and postoperative review, resulting in less radiation exposure to the patient and the clinical team, reduced procedure time, and increased delivery confidence. This pilot programme will also inform the future development of predictive analytics to support procedure planning, by

assessing factors such as the risk of endoleaks, sac regression probability and more. Medtronic is the first medical technology company to enter a public strategic collaboration in digital endovascular technology to advance aortic patient treatment decisions, it claims. The collaboration is part of Medtronic’s ongoing commitment to innovation in aortic care for physicians and their patients. “Medtronic aims to revolutionise endovascular aortic treatment with digital solutions with this phased approach. By collecting data across the patient journey—before, during and after procedure—our goal is to provide analytic support to make our endovascular stent grafts ‘smart’,” Carolyn Sleeth, a vice president and general manager at Medtronic, explained. “By collaborating with Medtronic to bring our Cydar EV Maps solution to up to 40 new hospital sites, we are a step closer to achieving our mission to ensure every image-guided endovascular procedure goes exactly as planned,” said Paul Mussenden, CEO of Cydar.

Calendar of events

LimFlow recently announced it has closed a US$40 million (€36 million) oversubscribed Series D financing round. A press release reports that new investors Longitude Capital, Soleus Capital Management, and an undisclosed strategic investor joined the round along with current major shareholders of the company: Sofinnova Partners, through its Crossover Strategy fund; Bpifrance, the French sovereign investment bank; and Balestier, a Singaporean family fund.

LimFlow stent

The LimFlow system, designated by the US Food and Drug Administration (FDA) as a Breakthrough technology, uses a minimally invasive family of transcatheter products designed to optimise perfusion of the critically ischaemic foot, potentially avoiding major amputation, resolving pain, and promoting wound healing.

15–18 June Society for Vascular Surgery (SVS) Vascular Annual Meeting Boston, USA

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

6–9 June Leipzig Interventional Course (LINC) Leipzig, Germany

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

31 October–3 November Vascular InterVentional Advances (VIVA) Las Vegas, USA

www.leipzig-interventional-course.com/ visitors/linc-2022

12–14 June 25th European Vascular Course (EVC) Maastricht, The Netherlands www.vascular-course.com

BD recently announced it has acquired Venclose, a provider of solutions for the treatment of chronic venous insufficiency (CVI). “We are committed to setting a new standard of excellence for people living with venous disease, and that starts with providing physicians with innovative technologies,” said Paddy O’Brien, worldwide president of Peripheral Intervention for BD. “Our acquisition of Venclose will enable us to offer a more robust portfolio of solutions to physicians who are treating the full range of venous conditions. “The Venclose radiofrequency (RF) ablation system strategically complements our categoryleading portfolio of venous disease technologies and aligns with our focus on innovations that provide transformative solutions to improve outcomes for chronic disease and enable the transition into new care settings.” The Venclose system provides two heating length sizes (2.5cm and 10cm) in one 6Fr-sized catheter. This dynamic dual heating length catheter provides multiple operational benefits to physicians, a press release from BD states. Venclose was founded in 2014 to enhance the treatment of CVI through RF ablation technology.

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

26–27 May Pacific Northwest Endovascular Conference (PNEC) Seattle, USA pnec-seattle.org

BD acquires Venclose to extend chronic venous disease treatment portfolio

www.vascular.org/vam

cirse.org/events/cirse-2022

esvs.org/events/annual-meeting

viva-foundation.org

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

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

15–19 November VEITHsymposium New York, USA

www.veithsymposium.org/index.php

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