Vascular News 93 – March 2022

March 2022 | Issue 93

Featured in this issue:

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CX 2022 Global vascular event returns to in-person format

Profile: Palma Shaw page 18

Social media: Best practice guidance published

page 24

CX 2022 faces challenges and opportunities in the vascular world Anticipation is building for the Charing Cross International Symposium 2022, which this year will address some of the key challenges currently facing the vascular field—from the ongoing impact of COVID-19 on vascular patients and providers, to the pressing matter of the “hurting leg” and unnecessary amputations.

The symposium will bring together world-leading experts in the space and feature three days of in-person education in London, UK, as well as virtual and on-demand viewing options for a wider global audience.

Population-based data project unmasks “frightening” trends in worldwide vascular disease burden Smoking-related diseases, including many vascular diseases, are not only a 20th-century health concern. In fact, by far the largest number of smoking-related deaths will occur in the 21st century unless smoking rates fall. Furthermore, the burden of vascular disease will increase even in parts of the world where smoking rates are falling, largely due to an ageing population.

This is all according to Peter Rothwell, Action Research professor of Neurology at the University of Oxford (Oxford, UK) and founding director of the Wolfson Centre for the Prevention of Stroke and Dementia.

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n developed nations, smoking rates have been falling “dramatically” since peaking in the 1960s and 1970s, Rothwell notes, with subsequent falls in rates of lung and other smoking-related cancers. Data from other parts of the world tell a very different story, however, with smoking rates increasing in countries such as China and India. There could be “up to a billion” smoking-related deaths by the end of this century, Rothwell communicates, dwarfing a figure of around 100 million in the 20th century. “We think of smoking-related disease as being a 20th-century problem. In fact,” he warns, “we have not even started to scratch the surface at a worldwide level”.

According to Rothwell, reduced rates of smoking and widespread use of statins will have a “substantial positive impact” on the burden of vascular disease in high-income countries. However, he cautions that the number of patients requiring investigation, treatment, rehabilitation

and care “will still continue to increase” due to an ageing population, inadequate control of blood pressure, inadequate uptake of anticoagulation for atrial fibrillation (AF), and increasing obesity and diabetes. In addition, he highlights a “worrying” recent reversal of the previously falling incidence of some vascular diseases at younger ages.

The Oxford Vascular study has gathered extensive data on the incidence and outcomes of vascular diseases that provide snapshots of patterns and changes in disease burden. Since its inception in 2002, this population-based study has aimed to ascertain and assess on a daily basis all acute vascular events, including transient ischaemic attacks (TIAs), strokes, coronary events and peripheral vascular events, in a population of about 95,000, Rothwell explains,

RUNNING FROM 26–28 APRIL, THE comprehensive programme will explore challenges to practice in all vascular domains, including peripheral arterial, aortic, venous, vascular access, acute stroke and vascular trauma. Live, edited live and workshop demonstrations will complement the main sessions, and experts in every field will weigh up the important issues head-to-head in CX debates.

Present and future COVID-19 challenges

CX 2022 will open with a dedicated session on the effect of COVID-19 challenges upon vascular management, addressing present and future issues. Speakers from around the world—including from the UK, Mexico, Finland, Italy, France and The Netherlands— will share their experiences of how the pandemic has affected and continues to affect vascular surgery patients.

The COVID-19 session will also address how the pandemic poses a significant challenge to skills learning and training of vascular specialists. The programme stresses the global nature of the issue, with speakers from the UK’s Rouleaux club, European Society for Vascular Surgeons in Training (EVST), the World Federation of Vascular Societies (WFVS) and the Society for Vascular Surgery (SVS) all taking to the podium.

A key focus: Addressing amputation rates

Another important focus at this year’s meeting will be the reduction of amputation.

Kristina Hagenström (University Medical Continued on page 6

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March 2022 | Issue 93

Top Story

Population-based data project unmasks “frightening” trends in worldwide vascular disease burden Continued from page 1

who credits his colleague Dominic Howard for recent analyses of the data on peripheral vascular events.

Rothwell referenced some of the group’s research during a talk on “Atherosclerosis burden in the ‘postsmoking era’” during the President’s Symposium on “our patients, the disease we treat and us” at the 2021 UK Vascular Societies’ Annual Scientific Meeting (VSASM; 1–3 December, Manchester, UK). Despite the title of his presentation, the speaker outlined the aforementioned concerning trends in smoking-related disease amidst a changing disease landscape.

The Oxford Vascular group’s work on stroke incidence highlights how an ageing population will increase the burden of disease. Rothwell explained that, while agespecific stroke incidence went down by about 40% from the 1980s to the 2000s, the number of strokes in this period actually went up by about 30%. “The population had aged so much that the denominator at older ages was so much bigger than it had been in the 1980s, and that is one of the problems we face,” he told the VSASM audience.

Looking ahead, the researchers forecast that stroke rates will increase significantly in years to come if incidence does not continue to fall rapidly. “We would be looking at about a 300% increase in the number of strokes in people over the age of 85 if we cannot continue to reduce the age-specific incidence,” he advised.

A second problem is that an ageing population might counterbalance the benefits of decreased smoking and increased statin use, as these positive trends will have less of an impact at older ages, Rothwell pointed out.

At VSASM, the presenter detailed that projections for the number of acute aortic aneurysms in the UK show a marked increase in the number of events between the ages of 75 and 85, telling the audience: “This will have implications for your practice, and also for screening programmes, and how we evolve aneurysm screening in the UK.” The picture is similar for peripheral arterial disease (PAD) and chronic limb-threatening ischaemia (CLTI).

Due in large part to an ageing population, absolute numbers are projected to increase despite reductions in smoking and despite control of hypertension, said Rothwell. He added that the number of people having an

aortic dissection is also projected to rise, attributing this partly to suboptimal blood pressure management. “The vascular surgical workload is not going to disappear any time soon,” he suggested.

Finally, Rothwell highlighted two areas of stroke where future trends do not look encouraging.

First, he noted that suboptimal uptake of anticoagulation for AF will impact the number of AF-related strokes and peripheral vascular events. The Oxford Vascular study group compared data from a 1980s study to their present data and found that, despite warfarin being invented and introduced into clinical practice for AF between the two studies, the number of AF-related strokes went up substantially, particularly at older ages. According to Rothwell, this is mainly because of underuse of anticoagulation at older ages.

Of 208 patients with AF-related stroke over the age of 80, only 9% were anticoagulated prior to their stroke, and no patients were anticoagulated over the age of 90.

“If you project the number of AF-related strokes as the population continues to age between now and 2050, the numbers are fairly frightening unless we can increase the rates of anticoagulation.”

While the incidence of stroke overall is coming down, the incidence of AF-related stroke “certainly is not,” said Rothwell. In fact, he expressed his understanding that “the number of AF-related strokes over the age of 85 will probably quadruple over the next two or three decades unless we can get more patients anticoagulated,”

The number of patients that vascular surgeons will need to see will continue to increase.” stressing that this comes with “enormous costs” in terms of health and social care.

Second, the incidence of young stroke is also starting to rise, Rothwell informed the VSASM audience, admitting the reasons behind this increase are unclear.

“Stroke rates below the age of 55 are going up in the UK and across the developed world,” he communicated, remarking it is “incredibly worrying” that falling rates of vascular disease over the last 50 years “might now be reversing” in younger age groups. “This could be the canary in the coal mine for a less bright future than we have all hoped for.”

While reduced rates of smoking and the widespread use of statins will certainly have an impact on the burden of vascular disease, Rothwell concluded that the number of patients that vascular surgeons will need to see will continue to increase.

News in brief

The latest stories from the vascular world

n DISPARITIES IN CARE: “Where you live and the colour of your skin can put you at much higher risk of amputation,” Barry Katzen (Miami Cardiac and Vascular Institute, Miami, USA) informed the audience at this year’s International Symposium on Endovascular Therapy (ISET 2022; 16–19 January, Hollywood, USA), opening a Town Hall session intended to highlight disparities in the delivery of vascular care and answer the pressing question: what can we do now?

For more on this story go to page 11. n REMOTE MONITORING: With the aim of addressing the longterm outcomes gap between patients based on their social deprivation status, Tara Mastracci (St Bartholomew’s Hospital, London, UK) tells Vascular News about the potential of a remote monitoring programme for dissection care, which is about to be launched in the UK.

For more on this story go to page 21. n CHRONIC VENOUS DISEASE GUIDELINES: The European Society for Vascular Surgery (ESVS) has released 2022 clinical practice guidelines on the management of chronic venous disease of the lower limbs. Writing committee chair Marianne G De Maeseneer (Erasmus Medical Centre, Rotterdam, The Netherlands) outlines the central takeaway messages from the paper and highlights what is new in the 2022 guidelines compared with the 2015 recommendations.

For more on this story go to page 26.

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CX 2022 returns to in-person format once more in the London spring 26-28 April 2022

BE A PART OF IT!

It is my personal pleasure and on behalf of the teams of CX 2022, Vascular News, Interventional Radiology News, Venous News, Cardiovascular News and Renal Interventions to invite you to the 44th Charing Cross International Symposium which has some differences this year.

As always, every three years we raise vascular and endovascular CONTROVERSIES to CHALLENGE the available evidence in order to reach CONSENSUS after a discussion with an expert audience. It is certainly a CHALLENGE year in the cycle, as CX 2022 is the first ever hybrid global vascular meeting in this transitional year. The vascular and endovascular community aches to meet together again in London as in normal times in late April, which is well into springtime. The whole profession wants to meet together again and so does industry to return to the way that we all work together in the patient interest.

CX 2022 is transitional simply because Olympia is being refurbished and we cannot predict the speed of return to normality. In addition, COVID-19 has dominated choices in patient management. Prevalence varies even now in various zones of the 80 or so countries who attend CX. In the meantime, we have “pivoted” to broadcast CX virtually and enabled education to reach far and wide despite the difficulties. So, hybrid it must be to be sure to reach you all. This year we shall meet at and stay in the Hilton London Metropole hotel, which can provide for us the equivalent of the Upper main, Lower main and Pillar Hall auditoria of Olympia Grand. We visualise an audience of around 2,000 on site with live broadcast of all programmes to those of you who cannot make it to be with us. We have reached more than 6,000 additional audience members with our broadcasting live streaming. It is not the time to discontinue that at this moment, but the aim is to be present in person, rekindling the collective spirit of camaraderie and sharing of ideas that can only be fully realised when we meet together personally.

We are in transition for other reasons. It is evident that global practice of vascular management has been disturbed recently.

Some of you have not been able to leave your homes. When you have, your hospitals have focused upon COVID-19 and less urgent matters have been placed on the “back burner” as waiting lists rise and diseases progress—this is reflected in the programme of CX 2022.

We therefore begin CX 2022 with “CX effect of COVID-19 challenges upon vascular management now and future”. We shall hear input from Great Britain, Ireland and Finland before turning specifically to address “Challenges to skills learning and training of vascular specialists” with contributions from Rouleaux club trainees in Great Britain, Ireland and European Vascular Surgeons in Training as well as the secretary of the World Federation of Vascular Societies (WFVS), Palma Shaw. Then it is a privilege that the president of the Society for Vascular Surgery (SVS) has nominated Jason T Lee, president of the Association of Directors of Vascular Surgery in North America to inform us of the concerns within the SVS on effect of the dreaded virus upon vascular training. Indeed, there is a need to recruit the finest of tomorrow’s physicians to our wonderful speciality where so many world leaders will educate at CX 2022.

Whilst some aspects of our practice are subdued, this does not apply to urgent matters such as the “hurting leg”, at risk of major amputation mainly from either peripheral arterial or venous disease, which is occurring in apparently thriving countries like the UK and Germany. We shall hear that legs are being amputated under our very noses without investigation to detect underlying vascular disease. It is not a time for physicians and surgeons to take a rest but to rise to the challenge. Aortic aneurysms can still rupture whilst eyes are turned to COVID-19 patients. Vascular trauma continues. As such, the CX programme reflects the challenge faced by the global community in 2022.

We hope that you will come and join us in London. Though, understanding the challenging times we currently face, if you register and are then unable to travel, we shall return the difference in registration fee so that you may still tune in virtually to the outstanding education from the very finest healthcare professionals of the world of surgery, radiology and cardiology.

So looking forward to greeting you.

Yours, Roger Greenhalgh

Register now www.cxsymposium.com/cx2022/registration/

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March 2022 | Issue 93

CX 2022

CX 2022 faces challenges and opportunities in the vascular world Continued from page 1

Center Hamburg-Eppendorf, Hamburg, Germany) will open the session on peripheral arterial challenges by speaking on “Timely interventions by specialists and guideline-based treatment to reduce amputation rates”.

The topic of amputation reduction will also be an important element of a day-long session dedicated to chronic limb-threatening ischaemia (CLTI) and “hurting leg” challenges. Topics on this day will

important talking points ahead of the April event.

“We now have a couple of devices with three branch options—total endovascular repair of the arch, a percutaneous approach, or to have a less or minimally invasive approach.”

Tara Mastracci (St Bartholomew’s Hospital, London, UK) reflects on the importance of developing more accurate fusion technologies and non-ionising radiation guidance. Techniques and technologies aimed at reducing radiation dosage and exposure are set to feature prominently throughout the CX 2022 programme.

“Technically, intraoperatively, getting more accurate fusion technology is something that I am super excited about, and I am excited to learn more about aortic deformation,” says Mastracci. “I cannot wait to see

sits on the CX 2022 aortic executive board.

“The most pressing aortic challenges that I look forward to learning more about at CX 2022 and seeing the discussion about new techniques is stroke in TEVAR,” says Kölbel. “There are some new techniques that make stroke less likely to occur during TEVAR including carbon dioxide flushing. I know that there are new data prepared to be shown at CX 2022 and I look forward to seeing those.”

The aortic programme will also include a techniques and technologies session, during which Wei Guo (Chinese PLA General Hospital, Beijing, China) will perform a live G-Branch (Lifetech Scientific) case.

Several aortic Podium 1st presentations will feature, including “How sac regression at one year affects allcause mortality at extended timepoints: key insights from the ENGAGE registry”.

Vascular Access Masterclass to address challenges in creation, maintenance and salvage

This year’s Vascular Access Masterclass will cover challenges in creation, maintenance and salvage of vascular access in patients with limited access options.

Innovations and technologies that have come to the forefront in recent years and how they may prove useful in creation and salvage of access will also be discussed. In addition, the CX audience can expect to see a Podium 1st presentation on 36-month results from the IN.PACT AV Access study, as well as an array of case studies in access.

Dedicated sessions to deliberate key acute stroke and vascular trauma challenges

CX returns to an inperson format for 2022

include inequalities in epidemiology of amputations and developing consistency of care for CLTI by closing the gap between vascular and cardiac care. The cost of endovascular limb preservation versus amputation will also be considered.

In addition, the session will highlight guidelines, namely the 2022 update of the 2020 European Society for Vascular Surgery (ESVS) guidelines on acute limb ischaemia in light of the COVID-19 pandemic.

A new feature of the peripheral arterial programme this year will be a whole day of live and edited cases.

The session will feature a series of live cases with Thomas Zeller (University Heart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany), a member of the CX 2022 peripheral arterial executive board, interspersed with edited cases by Koen Deloose (Sint Blasius Hospital, Dendermonde, Belgium), Michael Lichtenberg (Vascular Center Arnsberg, Klinikum Hochsauerland, Arnsberg, Germany) and Arne Schwindt (St Franziskus Hospital, Münster, Germany).

The latest evidence in the space will be highlighted in a series of Podium 1st presentations, including randomised trial data from the NeSIC trial on the place of neuromuscular electrical stimulation for intermittent claudication.

Aortic challenges: Arch repair, radiation reduction and stroke prevention

The aortic challenges programme aims to highlight novel approaches to the most pressing abdominal, thoracic and juxtarenal aortic, as well as radiation, challenges and focus on advancements at the forefront of the aortic field.

According to Stéphan Haulon (Hôpital Marie Lannelongue, GHPSJ, Paris, France), arch repair is among the important areas for discussion in the aortic space. “The next challenge in the aortic world is the repair of the arch,” Haulon, a member of the CX 2022 aortic executive board, comments, reflecting on the

how the technologies emerge for non-ionising radiation guidance and other ways that we can use vessel guidance in the operating room that does not expose us to radiation.”

New techniques to prevent stroke in thoracic endovascular aortic repair (TEVAR) are among the important areas highlighted by Tilo Kölbel (University Heart Center Hamburg, Hamburg, Germany), who also

The acute stroke programme will feature a series of debates on key topics in the space, including whether or not transcarotid artery revascularisation (TCAR) is a safe and effective alternative to transfemoral carotid artery stenting (CAS) or carotid endarterectomy (CEA) in the treatment of patients with symptomatic internal carotid artery stenosis.

In the vascular trauma challenges session, experts will cover topics including endovascular bridges to definitive care, neck and extremity vascular trauma and torso challenges, which will feature a debate on whether or not outcomes in vascular trauma patients should be included in the National Vascular Registry.

Venous and lymphatic challenges: “We are at a turning point in venous disease” This year’s venous and lymphatic programme will cover various challenges in the field—ranging from appropriate care conundrums to venous challenges in relation to the “hurting leg”. Challenges related to the superficial, deep and pelvic veins, as well as venous wounds, will be addressed.

According to CX 2022 venous and lymphatic that she will be presenting cases focusing on the executive board member Erin Murphy (Sanger recognition and management of some venous Heart and Vascular, Atrium Health, Charlotte, complications that have recently come to the USA), there has been a “rapid expansion” in the attention of specialists. “We are starting to see deep venous space in recent times, both in terms some new, very unusual complications arising in of interest and technologies. “This shift is also addition to stent occlusions,” she notes. Murphy driving interest in the pelvic veins as well as the Erin Murphy stresses the importance of seeing not only how lymphoedema space,” Murphy communicates, these complications can be fixed, but also how noting that the combined interest in all of these areas will they can be prevented in the first place. ultimately lead to the best outcomes for patients.

Murphy encourages wide participation in this year’s CX One of the subjects on this year’s programme is venous and lymphatic programme. “We are at a turning venous stenting. While this is a deep venous intervention, point in venous disease,” she notes, emphasising that, in says Murphy, she stresses that the superficial and deep order for the subject to move forward, those interested venous systems are related and that both need to be in the space “really need to come together to discuss, taken into account in the patient interest. “It is really learn, and elevate the field to the next level. This requires not unusual any more that we need to be considering not only advances in technology, but also in making sure interventions in both systems,” Murphy believes. “The we are addressing all components contributing to venous spaces have long been regarded as separate and are now hypertension, selecting the right patients for intervention, coming together.” and preventing complications.”

New to this year’s venous and lymphatic programme “I am very much looking forward to seeing everybody will be the inclusion of a series of edited cases within in person. I think education is so much more valuable in the main programme to illustrate teaching points more that format, so I do encourage everybody to attend in concisely, a change endorsed by Murphy, who explains person this year if feasible.”

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March 2022 | Issue 93

Journal Highlight

PERIPHERAL

Outcomes similar for exercise therapy and endovascular revascularisation in “largest” yet “limited” study Both a strategy of primary supervised exercise therapy (SET) and primary endovascular revascularisation improve maximum walking distance on a treadmill and disease-specific quality of life in patients with intermittent claudication caused by an iliac artery obstruction. Taking into account “many limitations”, this is the main finding of a recent multicentre, randomised controlled trial.

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esults of the SUPER (Supervised exercise therapy versus endovascular revascularisation) study, authored by Mark J W Koelemay (Amsterdam UMC, Amsterdam, The Netherlands) and colleagues on behalf of the SUPER study collaborators, were recently published online ahead of print in the European Journal of Vascular and Endovascular Surgery (EJVES).

According to the authors, SUPER is the largest study in the field to date and “supports current guidelines to start with SET in patients with mild intermittent claudication, including when the obstruction is in the iliac arteries”. However, Koelemay et al stress that the study is limited by various factors, including premature termination, crossover to endovascular revascularisation, and poor compliance with SET. In order to test their hypothesis that primary endovascular revascularisation might be more effective in patients with iliac artery obstruction, the investigators randomly allocated patients to SET or endovascular revascularisation stratified for maximum walking distance and concomitant superficial femoral artery disease. The primary endpoints were maximum walking distance on a treadmill (3.2km/h, 10% incline) and disease-specific quality of life (VascuQol) after one year. Additional interventions during a mean follow-up of 5.5 years were recorded, the authors add.

Between November 2010 and May 2015, the research team allocated 114 patients to SET and 126 to endovascular revascularisation.

They note the trial was terminated prematurely after 240 patients were included.

The authors reveal in EJVES that, after six months, 57/114 (50%) patients complied with SET and that 10 (8%) patients allocated to endovascular revascularisation did not receive this

intervention. They add that one-year follow-up was complete for 90/114 (79%) SET patients and for 104/126 (83%) endovascular revascularisation patients.

Koelemay and colleagues report the following outcomes: The mean maximum walking distance improved from 187 to 561m in SET patients and from 196 to 574m in endovascular revascularisation patients (p=0.69) VascuQol sumscore improved from 4.24 to 5.58 in SET patients, and from 4.28 to 5.88 in endovascular revascularisation patients (p=0.048) Some 33/114 (29%) SET patients had an endovascular revascularisation within one year, and 2/114 (2%) surgical revascularisation Some 10/126 (8%) endovascular revascularisation patients had additional endovascular revascularisation within one year and 10/126 (8%) surgical revascularisation After a mean of 5.5 years, 49% of SET patients and 27% of endovascular revascularisation patients underwent an additional intervention for intermittent claudication.

Limitations “hamper interpretation” of outcomes

The authors admit there are a number of issues that “hamper interpretation of the study outcomes”. Firstly, they note that the premature termination of the study was a key drawback. “Patient accrual was much slower than expected and this put a strain on budget, which stopped in May 2016,” they explain.

“Failure to include the required number of patients obviously limits the scientific validity with regard to observed outcomes, because the study may be underpowered.”

The researchers add that there were a number of crossovers in the study,

with 29% of patients allocated to SET having an iliac artery endovascular revascularisation within one year. They elaborate: “Some patients who were allocated to SET felt as if they were denied a more effective treatment and immediately demanded to be crossed over to endovascular revascularisation or withdrew informed consent after randomisation.”

Another limitation Koelemay et al acknowledge is that only half of the patients complied with some form of SET, and only one third of participants had SET according to the study protocol. Clarifying the reason for this, the authors detail that the Dutch government stopped reimbursement of SET by health insurance companies during the course of the study. “As the authors did not have the financial means to provide SET for patients affected by this measure,” they write, “some decided to withdraw participation while others continued to participate in the study, albeit without SET.” Other limitations the authors recognise include a complete followup rate of only 80%, and the fact that walking distance on a treadmill may

Patient accrual was much slower than expected and this put a strain on budget, which stopped in May 2016.”

not be an endpoint that captures clinical improvement, “because patients who train regularly on a treadmill become familiar with the device and may have an advantage over those who do not have SET,” they communicate.

“Real-world” picture or “failed experiment”?

Against the backdrop of these issues, the authors believe that the results of the SUPER study can be interpreted in two ways.

The “pragmatic view,” they write, would be to regard the study as a “representation of a real-world setting,” in which “not all patients fully comply with SET, have their own preference regarding treatment, and may experience a failed revascularisation attempt”.

On the other hand, Koelemay and colleagues believe clinicians could regard the SUPER study as a “failed experiment” due to the numerous limitations, and infer that “referring patients for SET is cumbersome, because of low patient compliance and motivation and a high likelihood of failure”.

Taking a step back, the authors posit that the similarity in outcomes between SET and endovascular revascularisation “seems to be an ideal opportunity to discuss the pros and cons of both treatment options and find out with shared decision-making which treatment fits best with the preferences of the patient”. They also stress the importance of patient choice: “It seems reasonable to start with SET in [patients with intermittent claudication caused by iliac artery obstruction] and accept a 30% failure rate, which must, of course, be discussed with the patient.”

Cost-effectiveness analysis reinforces current studies and guidelines ON BEHALF OF THE SUPER STUDY COLLABORATORS, NICK S VAN Reijen (Amsterdam UMC, Amsterdam, The Netherlands) and colleagues conducted a cost-effectiveness analysis on endovascular revascularisation versus exercise therapy for intermittent claudication due to iliac artery obstruction. This was published online in the EJVES in parallel with Koelemay et al’s study, on which the analysis was based.

The authors summarise their findings: “Endovascular revascularisation as a primary treatment results in slightly better health outcomes and higher qualityadjusted life years (QALYs) and health-related quality of life (HRQOL) during 12 months of follow-up. Although these differences are statistically significant, clinical relevance must be discussed due to the small differences and relatively high cost of endovascular revascularisation as primary treatment.”

Using data from the SUPER study, the investigators found that the mean costs for patients allocated to endovascular revascularisation were €4,031 and €2,179 for SET, with a mean difference of €1,852 (95% bias corrected and accelerated [bca] bootstrap confidence interval [CI] 1,185–2,646). They add that the difference in QALYs during follow-up was 0.09 (95% bcaCI 0.04–0.13) in favour of endovascular revascularisation and that the incremental cost utility ratio (ICER) per QALY was €20,805 (95% bcaCI 11,053–45,561). Finally, they relay that the difference in VascuQol sumscore was 0.64 (95% bcaCI 0.39– 0.91), again in favour of endovascular revascularisation.

The present cost-effectiveness analysis is “in concurrence with previously conducted cost-effective analyses of these treatments,” van Reijen and colleagues communicate, adding that the results “support current guidelines in which SET is advised as primary treatment for patients with intermittent claudication, including when this is caused by an iliac artery obstruction”.

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Issue 93 | March 2022

Conference Highlight 11

Societies take action to address disparities in vascular care

emphasised the importance of serving the community by understanding that “we need to educate them, help them understand that a distal amputation requires ongoing surveillance, and we need to meet people where they are, by raising awareness of the options for limb preservation”.

Key society action points

“Awareness is the number one challenge for all of us.” This was Barry Katzen’s (Miami Cardiac and Vascular Institute, Miami, USA) key takeaway message from a Town Hall session on disparity in the delivery of vascular care at this year’s International Symposium on Endovascular Therapy (ISET 2022; 16–19 January, Hollywood, USA). The session was co-developed with the CLI Global Society and supported by an educational grant from Boston Scientific.

K

atzen informed ISET attendees that 150,000 non-traumatic amputations occur in the USA each year and stressed that this number is rising. He also highlighted that “where you live and the colour of your skin can put you at much higher risk of amputation”. The ISET Town Hall was intended to elevate what Katzen labelled a “critical public health and social issue” as well as answer the pressing question: what can we do now?

“Awareness, awareness, awareness is key” The first speaker, Foluso Fakorede (Cardiovascular Solutions of Central Mississippi, Cleveland, USA), reflected on the significance of the day on which the Town Hall convened—Martin Luther King Jr Day. He recalled one of King’s beliefs that, “of all forms of inequality, injustice in healthcare is the most shocking and inhuman because it results often in physical death, preventable death”. Fifty-six years later, “we are still here,” the speaker lamented, “trying to put together our collective thoughts on how to carry on this conversation around health injustice manifesting as health inequity, and the Black amputation epidemic speaks to those sobering words”.

When referring to “the Black amputation epidemic,” Fakorede is referencing a May 2020 article published in ProPublica that gives an insight into Fakorede’s work and his patients in Mississippi—an area where the speaker noted Black patients were losing their limbs at triple the rate of others.

Panellist Raghu Kolluri (OhioHealth, Columbus, USA) recalled the impact this paper had on the vascular community: “[It] hit us all pretty hard. We started looking into ourselves as a society and how to have a pipeline of providers who can help people who understand their constituents.”

There are disproportionately higher amputation rates in minorities and these are evident in the literature, Fakorede communicated, before setting out a goal of avoiding amputation as a first-line treatment for chronic limb-threatening ischaemia (CLTI) patients. “This will involve elucidating predictors of amputation risk, taking a holistic approach to the identification of risk factors, and designing an effective, alternative treatment algorithm,” the speaker explained.

Fakorede proposed a multilevel strategy to address healthcare disparities in peripheral arterial disease (PAD) and CLTI, ranging from creating policies to recruit and increase underrepresented and disadvantaged students in science to using “primetime” slots during annual conferences to highlight healthcare disparities. One of the key action points will be to increase general public awareness of disparities in healthcare, said Fakorede, emphasising that “awareness, awareness, awareness is key”.

“We are dealing with 20% of the problem” Disparity in the delivery of vascular care has been acknowledged in the literature for over 20 years, and is a bigger problem than is often recognised, the Town

Hall session revealed. Jihad Mustapha (Advanced Cardiac & Vascular Centers for Amputation Prevention, Grand Rapids, USA) addressed data on racial disparities and in particular early studies on the topic, noting that the problem has been recognised since the 1990s.

Also speaking on trial data, Sanjay Misra (Mayo Clinic, Rochester, USA) stressed that “we are dealing with 20% of the problem,” referring to medical management, amputations and revascularisation.

“Probably 80% of the problem is other factors,” he conjectured, urging that “we really need to understand those other factors so we can help our patients”.

Addressing the current and ongoing backdrop of a

Stephanie Silverman

Foluso Fakorede

Vickie Driver

We need one unified voice, one unified statement about what PAD is and we need to spread that nationally and internationally.”

Foluso Fakorede

pandemic, Vickie Driver (Inova Heart and Vascular Institute, Falls Church, USA) clarified that “disparities existed long before COVID-19 emerged,” noting, however, that “it is clear now that disparities are on the rise in the face of COVID-19, and it is not getting any better”. In fact, she relayed, “it is getting worse”.

Due to the fact that limb-preserving services were deemed “nonessential” with the onset of COVID-19, the amputation crisis became “a pandemic within a pandemic”. Within this context, Driver explained the concept of a “wound centre without walls”—a strategy to “untether wound care from a physical location” and “aggressively triage and provide care to patients with wounds across the spectrum of the health system, utilising technology and community-centred care”.

Addressing the question of how success in amputation reduction can be improved, Driver

After defining the problem, the Town Hall turned the focus to what is being done to address disparity in the delivery of vascular care, specifically at the society level. Yolanda Bryce (Memorial Sloan Kettering Cancer Center, New York, USA) relayed that the Society of Interventional Radiology (SIR) has prioritised a research agenda on the subject.

The research priorities include a randomised controlled trial with PAD screening of at-risk patients with oversampling of high-risk racial groups, a prospective trial with the introduction of an intervention to alter a social determinant of health, and a prospective trial with the implementation of an algorithm that requires criteria be met prior to an amputation, Bryce communicated.

The Society for Vascular Surgery (SVS) Foundation has also initiated a programme to address disparity in the delivery of vascular care—the SVS Foundation Vascular Volunteers In Service To All (VISTA) initiative. Addressing the ISET audience, Jens Eldrup-Jorgensen (Tufts University School of Medicine, Boston, USA) detailed that the initial focus of the VISTA programme, formed in 2021, will be on education, awareness and prevention before transitioning to full-scale clinical care.

There are currently three VISTA pilot projects underway, Eldrup-Jorgensen revealed: one focused on reducing amputations in the Native American population in Oklahoma, another on diabetic foot care in an urban population of African Americans and Hispanics in Houston, and a third on a rural population with limited access in the Central Valley of California.

Stephanie Silverman, board member of the American Diabetes Association (ADA) also spoke.

She detailed that, in late 2020, the ADA issued its Health Equity Bill of Rights. Number five on a list of 10 rights is that every person with diabetes has the right to avoid preventable amputations. Silverman stressed that “we have a lot of ground to make up for, a lot of work to do”.

Expanding representation in PAD trials

In the final presentation of the session, Maureen Kohi (University of North Carolina at Chapel Hill, Chapel Hill, USA) gave an overview of the ELEGANCE (Drug-eluting registry: real-world treatment of lesions in the peripheral vasculature) registry, with a focus on efforts to screen and enrol diverse groups previously underrepresented in PAD research.

Kohi detailed that 250 patients have been enrolled so far, over 40% of whom are women and over 30% of whom are underrepresented minorities.

“By emphasising diversity and inclusion in clinical trial leadership and patient enrolment, we can expand patient representation in PAD trials and improve clinical decision-making and outcomes,” the presenter told the ISET audience.

“We need a unified voice”

Closing the session, Fakorede reflected: “This has been probably one of the most rewarding sessions that I have attended, because the width and breadth of everything that was mentioned today encompasses what it takes to really come up with a solution.”

“I think now that we have everyone in one room, we need to do a better job to start with awareness. As soon as we all leave this conference and I walk out of this door, our patients do not know what PAD is. We need one unified voice, one unified statement about what PAD is and we need to spread that nationally and internationally.”

March 2022 | Issue 93

12 Conference Coverage

PERIPHERAL

ISET 2022 audience hears latest data on endovascular therapies At this year’s International Symposium on Endovascular Therapy (ISET 2022; 16–19 January, Hollywood, USA), experts presented an array of late-breaking trial results on topics ranging from venous stenting to abdominal aortic aneurysm (AAA) sac sealing.

GEORGE ADAMS (UNC REX HEALTHCARE, Chapel Hill, USA) delivered the results of a pooled subanalysis from the Tack optimised balloon angioplasty (TOBA) studies of the Tack endovascular system (Intact Vascular/Philips). The TOBA studies are unique, he informed the ISET audience, in that they are the first and only studies to enrol 100% dissected arteries. The studies demonstrate very low rates of clinically-driven target lesion revascularisation (CD-TLR) and bailout stenting, he summarised, concluding that dissection repair with Tack produces positive short- and long-term results while preserving future treatment options.

Relaying findings from a multicentre experience with the 4Fr WavelinQ endovascular arteriovenous fistula (endoAVF) system (BD), Bulent Arslan (Rush University Medical Center, Chicago, USA) detailed rates of 72% primary patency, 88% secondary patency, 78% successful two-needle cannulation and 80.7% freedom from reintervention in 120 patients—the largest series to date, he claimed.

Arslan encouraged attendees to look out for the results of ongoing clinical trials in the space.

Also on the agenda were the latest data on venous stenting. Erin Murphy (Sanger Heart and Vascular, Atrium Health, Charlotte, USA) outlined 24-month data from the ABRE trial—a prospective, multicentre,

single-arm study of 200 patients with symptomatic iliofemoral venous outflow treated with the Abre venous self-expanding stent system (Medtronic).

The presenter revealed that effectiveness was sustained though 24 months, with a primary patency of 85.7% and freedom from CD-TLR of 90.9%.

In addition, Murphy communicated that no stent

In the ABRE trial, effectiveness was sustained through

24

months

with a primary patency of

85.7%

freedom from CD-TLR

90.9%

fractures and no stent migrations were reported through 24 months. Finally, the presenter detailed that all patients demonstrated sustained and clinically meaningful improvements in quality of life measures and venous functional assessment scores at 24 months.

In the abdominal aortic space, Andrew Holden (Auckland Hospital, Auckland, New Zealand) spoke on AAA sac sealing with the Impede-FX RapidFill

embolisation plug (Shape Memory). He conveyed early data from the AAA-SHAPE early feasibility studies—prospective, multicentre investigations being conducted at two centres in New Zealand and three in The Netherlands. In the period September 2020–December 2021, 16 patients were treated for endovascular aneurysm repair (EVAR), Holden detailed, reporting a 100% technical success rate so far and concluding that AAA sac filling during EVAR with Impede-FX RapidFill may improve aneurysm sac regression and reduce endoleak. However, he stressed that these are preliminary data from an ongoing investigation and that continued studies with long-term follow-up are needed.

Finally, Ripal Gandhi (Miami Cardiac and Vascular Institute and Miami Cancer Institute, Miami, USA) expanded on an interim analysis of the RESCUE trial presented by Akhilesh Sista (New York University School of Medicine, New York, USA) at Vascular InterVentional Advances (VIVA) 2021 (5–7 October, Las Vegas, USA). The RESCUE trial is a multicentre, prospective single-arm clinical trial, which is evaluating the safety and efficacy of pharmacomechanical catheter-directed thrombolysis with the Bashir endovascular catheter (Thrombolex), specifically in patients with intermediate-risk acute pulmonary embolism (PE). The interim analysis included 62 patients and showed a reduction in the right ventricular to left ventricular (RV/LV) ratio of 32.1% at 48 hours. “The new datapoints are that there was a 90% reduction in the number of totally occluded segmental pulmonary arteries, and a 72% reduction in the total, or subtotal occlusions by 48 hours, as measured on a CT angiogram. This is really remarkable, because when we look at this reduction, this treatment is quite striking, and has never been reported with any other treatment modality that we have seen yet for PE,” Gandhi told Vascular News.

“Experience matters” when predicting patient outcomes following major lower limb amputation RESEARCH INDICATES THAT healthcare professionals perform better than risk prediction tools at predicting 30-day mortality, morbidity, and revision risk in patients following major lower limb amputation. The PERCEIVE study is led by chief investigator David Bosanquet (Royal Gwent Hospital, Newport, UK), funded by Health and Care Research Wales’ Research for Patient and Public Benefit scheme, and delivered by the Centre for Trials Research (Cardiff University, Cardiff, UK) and the Vascular and Endovascular Research Network (VERN). Presenting early data from the PERCEIVE study at the UK Vascular Societies’ Annual Scientific Meeting (VSASM 2021; 1–3 December, Manchester, UK), Brenig Gwilym (Royal Gwent Hospital) stressed that determining the accuracy of healthcare professionals’ predictions is extremely important when validating risk prediction tools to put their performance into context.

“There are a lot of risk prediction tools and they seem to perform very

well,” Gwilym, a trainee vascular surgeon, told the VSASM audience.

However, he remarked that “the reality is, only a few validation studies are performed”. It is known that healthcare specialists are less accurate in predicting long-term outcomes compared to short-term outcomes, Gwilym noted, and therefore the research team set out to investigate how accurate healthcare professionals and amputation risk prediction tools are at predicting outcomes.

Additionally, the investigators aimed to analyse the accuracy of predictions across seniority and profession.

The team prospectively collected data for 537 patients across 41 centres over a period of seven months, from October 2020 to May 2021. Inclusion criteria were emergency and elective procedures, and chronic limbthreatening ischaemia, diabetes and acute limb ischaemia as indications.

Paediatric, trauma, cancer and revision cases were excluded from this study.

The presenter detailed that healthcare professionals (2,500

Brenig Gwilym at VSASM 2021

Determining the accuracy of healthcare professionals’ predictions is extremely important when validating risk prediction tools to put their performance into context.”

predictions)—including consultant surgeons, consultant anaesthetists, trainee surgeons (registrars), and trainee anaesthetists (registrars)—were asked to give preoperative predictions for 30-day outcomes as a percentage for mortality, morbidity and revision.

A total of 11 mortality risk prediction tools were included, with one for morbidity and one for revision risk.

Gwilym mentioned that, out of the 52 deaths and 100 morbidity cases, 20 and 17 were due to COVID-19, respectively. Healthcare professionals were deemed “good at predictions, with a general overestimation of risk,” with trainee surgeons performing the worst. Compared to the prediction risk tools, healthcare professionals predicted mortality better in all cases but one, the presenter reported.

In addition, the researchers found that healthcare professionals predicted morbidity less accurately, with consultants performing slightly better.

Furthermore, Gwilym described healthcare professionals as “good at predicting revision risk”. However, he emphasised that “experience matters— so consultant surgeons were more accurate than the trainees at predicting revision risk”.

Gwilym summarised that healthcare professionals were “reasonably good” at predicting mortality and revision risk in this cohort, but that morbidity has proven difficult to predict.

Issue 93 | March 2022

Conference Coverage 15

AORTIC

US IDE Aortic Research Consortium “pushes the envelope” on fenestrated and branched procedures The US investigational device exemption (IDE) Aortic Research Consortium has produced the strongest data so far on the use of fenestrated/branched endovascular aneurysm repair (F/BEVAR), Andres Schanzer (University of Massachusetts, Worcester, USA) claimed at Critical Issues in Aortic Endografting 2021 (17–18 December, Paris, France). As a result of the group’s work, “more patients are getting better care, by more providers, using F/BEVAR devices,” he remarked, summarising key datasets presented since 2018.

THE PRIMARY OBJECTIVE OF the US F/BEVAR Aortic Research Consortium (US-ARC), first conceived of in 2018, is to evaluate custommade fenestrated and branched endovascular devices for the treatment of patients with complex abdominal, thoracoabdominal and arch aneurysms, Schanzer detailed. He noted that, currently, the literature includes primarily iterative, single-centre reports, the findings of which “may be limited due to the potential for a type 1 error secondary to limited statistical power”. According to Schanzer, medical director of US-ARC, that is about to change, as the US-ARC includes prospective, physiciansponsored data from across 10 US sites and is independently monitored and US Food and Drug Administration (FDA) audited. Referencing an email he sent to investigators when initiating this effort in early 2018, Schanzer communicated: “If we are able to pull this off and figure out a way to aggregate our data in a relatively seamless way and work together as a team of investigators, I believe we have the potential to make a much more significant impact than multiple iterative, single-centre reports.”

Key datasets highlight growing pool of evidence

Members of the US F/BEVAR ARC have presented data on behalf of the consortium at several key conferences since 2018. The datasets started off small, Schanzer relayed. At the Society for Vascular Surgery (SVS) 2018 Vascular Annual Meeting (VAM; 20–23 June, Boston, USA), for example, Emanuel R Tenorio (University of Texas Health Science Center at

Houston, Houston, USA) presented outcomes of endovascular repair of postdissection and degenerative thoracoabdominal aortic aneurysms (TAAAs) using fenestrated and branched stent grafts. The study, which incorporated 240 patients, showed F/ BEVAR to be safe and effective, with similar outcomes in patients with post-dissection and degenerative TAAAs, and also that patients with post-

that greater TAAA extent is associated with increased target instability. Future efforts, he informed the VAM audience, should focus on improving renal artery patency and reducing interventions.

Later that same year, Schanzer recalled that Carlos H Timaran (University of Texas Southwestern, Dallas, USA) gave evidence on the expanded use of preloaded branches and fenestrated endografts for endovascular repair of complex aortic aneurysms. Speaking at the 32nd European Society for Vascular Surgery (ESVS) Annual Meeting (24–28 September 2018, Valencia, Spain), Timaran presented data on 564 patients, concluding that the expanded use of preloaded catheters and wires of

US-ARC fact file

Andres Schanzer at Critical Issues 2021

dissection had more type II endoleak during follow-up. Tenorio stressed that larger clinical experience and longer follow-up was needed to better evaluate differences in mortality, spinal cord injury, target vessel instability and secondary interventions.

At the same meeting, Schanzer recounted, Darren B Schneider (University of Pennsylvania, Philadelphia, USA) presented target artery outcomes after branched and fenestrated endovascular repair of pararenal aortic aneurysms and TAAAs in 661 patients. Schneider summarised that the selective use of fenestrations and directional branches for visceral artery incorporation is durable, that the risk of target artery instability is higher for renal versus mesenteric arteries, and

(24–27 September 2019, Hamburg, Germany) the following year, Fernando Motta (The University of North Carolina, Chapel Hill, USA) informed the audience that F/BEVAR is a safe and effective option for octogenarians in training complex aortic aneurysms compared to non-octogenarians, Schanzer detailed, outlining data from 893 patients.

Finally, Schanzer gave an overview of the largest US IDE Consortium dataset so far—a study on sex-related outcomes after F/BEVAR for TAAAs involving 1,681 patients. Announcing the findings during ESVS Month (29 September–29 October 2020, online), Matthew P Sweet (University of Washington, Seattle, USA) revealed that women experienced higher rates of technical failure for extensive

Number of sites

Largest dataset so far

Active since

10

1,681

2018

More patients are getting better care, by more providers, using F/BEVAR devices.” fenestrations and directional branches for target artery incorporation is associated with even higher technical success and lower early mortality.

Schanzer then looked back to the 2019 VAM (12–15 June, National Harbor, USA), where he presented results of F/BEVAR after failed infrarenal EVAR in 893 patients. He noted that F/BEVAR was safe and effective in patients with prior failed EVAR, with nearly identical outcomes as compared to patients without prior EVAR, while differences in procedural metrics indicated higher level of technical challenge when performing F/BEVAR in patients with prior failed EVAR. The speaker concluded that F/ BEVAR, at high-volume centres, is a viable option for the treatment of EVAR failure that compared favourably to historical reports of open conversion.

At the 33rd ESVS Annual Meeting

aneurysms, non-home discharge and postoperative sac expansion.

A turning point for F/BEVAR

Addressing the Critical Issues audience, Schanzer summarised that the US F/ BEVAR ARC is the largest dataset of fenestrated and branched procedures in the world, involving a core group of investigators “committed to improving patient care and pushing the envelope on endovascular therapies from the aortic valve to the common femoral artery”. The consortium is “an engine for exchange of ideas and promotion of F/BEVAR technologies,” the speaker continued, emphasising his hope that the group’s work will have an impact not just in the USA but across the globe.

On a more practical level, Schanzer added, the consortium “offers infrastructure and a more agile regulatory pathway for testing emerging technologies to obtain preliminary data”, and also represents a departure from single-centre reports. The project provides a framework in which to conduct randomised trials, Schanzer stressed, noting that the trajectory of F/BEVAR technologies has reached an “inflection point”, and that larger studies will henceforth reveal the direction of travel in this developing field.

March 2022 | Issue 93

16 Journal Highlights

AORTIC

Guidelines recognise potential role for earlier endovascular treatment of uncomplicated type B aortic dissection NEW CLINICAL PRACTICE guidelines have been published, and are intended to act as “guard rails” to determine the treatment options and best practices for managing patients with type B aortic dissection. An important update in the document is the potential for earlier endovascular treatment in patients with uncomplicated type B aortic dissection at higher risk of progressive disease.

The guidelines, produced jointly by the Society of Thoracic Surgeons (STS) and the American Association for Thoracic Surgery (AATS) are published online in The Annals of Thoracic Surgery and The Journal of Thoracic and Cardiovascular Surgery.

The new document offers evidencebased recommendations that include employing a “stepwise approach” to the evaluation and treatment of patients with uncomplicated type B aortic dissection, followed by close clinical surveillance.

“There has been an explosion of information in the form of research reports of varying quality regarding

the treatment of type B dissection over the past decade,” said author G Chad Hughes (Duke University Medical Center, Durham, USA). “This guideline is unique in providing surgeons with a comprehensive, up-to-date summary of the state of the evidence, while also serving as ‘guard rails’ that outline treatment options and best practices in certain scenarios. This is a first for any document in the field of type B dissection management.”

According to the guideline, aggressive medical therapy is the first step and considered the gold standard for managing patients with uncomplicated type B dissection, while open surgery should be reserved for complicated cases.

Importantly, the guidelines recognise advances in less invasive treatment options for the disease, including the new role of earlier endovascular treatment like thoracic endovascular aortic repair (TEVAR) in patients with uncomplicated type B aortic dissection.

In the early phase of treatment, surgery previously was reserved for patients

Study suggests more proximal landing zone is preferred for TEVAR of acute type B aortic dissections A review evaluating the results of thoracic endovascular aortic repair (TEVAR) following acute type B aortic dissection suggests most patients with acute type B aortic dissection have less than 2cm of proximal healthy descending thoracic aorta. In patients treated for complicated acute type B aortic dissection, zone 2 TEVAR is associated with a lower need for aortic reintervention and aortic-related adverse events than zone 3 TEVAR. FURTHER, PATIENTS MAY BENEFIT FROM a more aggressive proximal landing zone with similar perioperative morbidity when zone 2 TEVAR is done with left subclavian artery revascularisation.

“TEVAR for the treatment of complicated acute type B aortic dissection has been shown to have favourable outcomes compared to both open aortic repair and medical therapy,” said corresponding author Jean Panneton (Eastern Virginia Medical School, Norfolk, USA). “However, the optimal approach for this therapy, including timing, coverage

who had complicated type B dissection; in later phases, for patients who had progression of their disease.

Now, the guidelines suggest that surgeons may be able to identify subsets of patients with uncomplicated type B dissection who have a higher risk of progressive disease and treat them earlier with TEVAR—before progression develops. However, this recommendation remains secondary to medical management, and patient selection still needs to be better defined in the future.

For complicated type B dissection patients, TEVAR or open surgery, depending on the anatomy, should

There has been an explosion of information in the form of research reports of varying quality regarding the treatment of type B dissection over the past decade.”

be the first-line treatment, according to the guideline. The collective data demonstrated improved outcomes with TEVAR for these patients compared to open surgery or medical therapy alone.

The guideline also states that for some type B dissection patients— such as those with connective tissue disorders or chronic dissections— whose disease has progressed despite medical therapy, a “more durable” open surgical repair may be recommended over TEVAR. “We expect this guideline to improve the quality of care of patients with type B aortic dissection by providing surgeons the most up-to-date summary of when and how to effectively use which therapies, whether open surgery, endovascular therapy, or a combination of the two, over the lifetime of the patient,” said Dawn S Hui (The University of Texas Health Science Center at San Antonio, San Antonio, USA).

“In contrast to individual studies, clinical practice guidelines are unique because they are a high-quality summary and synthesis of what is already known about this topic,” added Hui. “Guidelines are written according to a scientifically rigorous process.

Thus, they can help resolve conflicting findings of different studies or define what treatment options are best for specific circumstances.”

length and landing zone remains to be fully Postoperative spinal cord injury did differ between elucidated. the groups (p=0.012): “The aim of this study was to evaluate and ● Zone 3: 0% compare postoperative outcomes and late aortic● Zone 2C: 20% related adverse events in patients undergoing TEVAR ● Zone 2R: 2.6% for complicated acute type B aortic dissection with Subsequent retrograde aortic dissection was proximal endograft deployment in landing zones 2 observed in three patients (4%; one zone 2 and two versus 3.” zone 3 patients).

As reported in the January 2022 issue of The overall aortic reintervention rate at 36 months the Journal of Vascular Surgery (JVS), Panneton and after TEVAR differed significantly between the colleagues performed a retrospective chart review, groups (p=0.25): from a single centre, of adult patients who ● Zone 3: 31% underwent TEVAR for complicated acute ● Zone 2: 10% type B aortic dissection within six weeks of “The proximity of the primary tear to diagnosis. The chart review was for patients the origin of the left subclavian artery can treated from January 2008 to December make it difficult to achieve a secure 2cm 2018. Reviewers excluded patients with landing zone of healthy aorta without prior type A repair and connective tissue coverage of one of the aortic arch branch disorders. vessels. Notably, 90% of our study patients Eighty-three patients, with a mean age of Jean Panneton had a less than 2cm proximal landing zone, 60±12 years and average time to TEVAR said Panneton. of 4±8 days, were evaluated and separated into two “Factors which may contribute to the better study groups based on landing zone, with zone 2 outcomes observed for the zone 2 patients may patients subdivided into a further two groups: include a landing zone that is further away from the ● Zone 3: 9 aortic pathology and is more optimal in terms of seal ● Zone 2: 48 given it is less curved than in zone 3. ❍S ubclavian artery covered (C): 10 “Additionally, our low rate of retrograde dissection ❍S ubclavian revascularised (R): 38 may be related to avoiding proximal endograft Imaging evaluation revealed that only 11% of oversizing (>10%) and post-deployment balloon the study population had more than 2cm of healthy moulding.” descending aorta to land the TEVAR. Many technical details must be considered to Overall 30-day survival (88%) did not differ achieve excellent outcomes in this difficult patient between the groups (p=0.6): population, said JVS editors. “Strong consideration ● Zone 3: 89% for landing the TEVAR in zone 2, including ● Zone 2C: 80% subclavian artery revascularisation, appears ● Zone 2R: 90% important to better long-term outcomes.”

March 2022 | Issue 93

18 Interview

Profile

Palma Shaw

“As vascular surgeons, we never stop learning,” Palma Shaw tells Vascular News. This is one of the key attractions of the specialty for Shaw, who recalls various aspects of her career to date—from her early days learning endovascular surgery from Frank Veith to impacting the learning of others and addressing disparities in education across the globe in her role as secretary general of the World Federation of Vascular Societies (WFVS).

I have always had an interest in science and helping people live better lives. Medicine felt like a way to combine this and provided the intellectual challenges that I needed. My interest in surgery began in high school when I met a female plastic surgeon and spent time with her on rounds. I thought, wow, women can be surgeons too. In medical school I was exposed to vascular surgery and became captivated by open aortic aneurysm repairs and carotid endarterectomies. The process of repairing something that is broken or flawed to restore its integrity appealed to me. I remember as a medical student viewing the vascular surgeon as the hero who is called to stop bleeding during an emergency—so cool, calm and collected. I wanted to be like them.

At the end of my general surgery training, I was exposed to the wonders of endovascular surgery.

This was magnified by my most impactful year of learning with Frank Veith, who opened my eyes to the innovation and benefit of this new technology.

My formal fellowship with Bruce Brener allowed me to apply much of the knowledge I had acquired.

Endovascular techniques became a natural complement to vascular patient care. I could offer my patient the best care with either an open, endovascular or hybrid approach. As vascular surgeons, we never stop learning. My first job at Boston Medical Center gave me a deeper understanding of limb preservation with Gary Gibbons as my mentor. I welcomed the challenge of the diabetic foot and vascular disease, which is the source of high limb loss rates. I enjoy the collaboration required to form a multidisciplinary team in addressing this ever-growing clinical problem.

Who have been your career mentors?

My first mentor in vascular surgery was Frank Veith.

His teachings have formed my career. I learned resilience and tenacity from him. His commitment to the best care of the patient and viability of our specialty inspired and guided me.

My first partner in practice, Gary Gibbons, a maven in diabetic vascular disease, taught me many techniques for limb salvage and distal bypass surgery that I still use today.

Amy Reed was my first real female surgeon mentor.

She showed me how to be a leader of women among men in vascular surgery.

Linda Harris, a true educator and leader, has inspired me to take on leadership roles in different societies. I have been blessed to have these wonderful mentors and sponsors during my career.

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

The evolution of the endovascular repair of aortic pathology has decreased the morbidity associated with abdominal aortic aneurysm (AAA) repair and allowed those unfit for open surgery to have a durable repair.

This option has an even greater impact on thoracic

aneurysm repairs and intervention for thoracic aortic dissection.

How would you like to see the field develop over the next decade or so?

A balance needs to be reached between cost of care and quality of care. The durability and efficacy of interventions needs to be considered as endovascular interventions are performed more often and by a variety of interventionalists. In addition, a patientcentred approach will provide the best outcomes.

Optimal medical care and an informed decision considering the patient’s goals should continue to be emphasised in our day-to-day decisions. Repeat interventions that do not offer long-term benefit should be avoided. Often patients are given false hope, which drives up the costs of care. I hope that we can find ways to provide the best fit for procedure and patient.

Finally, more research is needed to define the best treatment of underrepresented minorities and women as many clinical trials have not enrolled adequate numbers. I anticipate better clinical trials with more women and underrepresented minorities as primary investigators.

What are the biggest challenges currently facing vascular surgery?

One of the biggest challenges is branding and the recognition of the vascular surgeon’s role and our contributions to society, and another is the rising

More research is needed to define the best treatment of underrepresented minorities and women.” epidemic of limb loss due to diabetes mellitus and downstream effects of the delay of care due to the pandemic.

What are your current areas of research?

My current areas of research are management of acute limb ischaemia and the evolution of management with new technology, and also limb preservation for chronic limb-threatening ischaemia.

In the last year, which new research paper has caught your attention?

The recently published paper by Brajesh K Lal et al entitled “Evaluating the optimal training paradigm for transcarotid artery revascularisation based on worldwide experience” (Journal of Vascular Surgery 2022; 75:581–9) caught my attention. This paper demonstrates that there are methods of training for transcarotid artery revascularisation (TCAR) which can effectively use cadavers or synthetic models to achieve dissemination of this knowledge and skillset similar to training using proctoring on live cases. Optimistically, this brings hope to the challenges we now have related

alisonlang.com

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

to the halting and reduction of case volumes secondary to the pandemic which have impacted our trainees and young surgeons. For a full report on this study, see page 29.

What have been the highlights of your role as secretary general for the WFVS so far, and what further goals do you have?

My involvement with the WFVS as secretary general has given me a wonderful opportunity to collaborate with leaders in the global vascular community. I joined at a time of transition in the middle of the pandemic when this federation needed to evolve into something more purposeful and modern. The executive council and the council members representing the different societies have redefined our mission, created new bylaws, realigned the website and defined future projects which are in line with our mission. The goal

Issue 93 | March 2022

Interview 19 is to improve the quality of care for vascular patients worldwide by providing a forum for the international exchange of scientific and educational knowledge related to the diagnosis, treatment and prevention of vascular diseases. We plan to address disparities in education by exploring alternative methods including access to a virtual educational programme and exploration of training paradigms which can help teach on a global scale. Limb preservation globally is a concern and collaboration between the WFVS and the Japanese Society for Vascular Surgery will expand the opportunity for trainees across continents to participate in their Distal Bypass Olympics remotely. Future projects involve assistance to underserved nations with too few vascular surgeons to offer them virtual education, communication through the WFVS Connect online and helping to align those interested in handson training to travel to other parts of the globe to learn new techniques. We can provide networking for the future vascular leaders of the world.

Could you talk a bit about your involvement in the new Women’s Section of the Society for Vascular Surgery (SVS)?

More than 20 years ago I decided to pursue a career in vascular surgery. I found very few female mentors at that time. We had no one to ask about how to manage our time if we wanted to have a family. We were afraid to speak up and ask to have the same opportunities as the men. Over time, pushing through many barriers, I met other women in vascular surgery who have fought similar battles. At this time, the SVS has committed to be supportive of diversity and equity. Women can be women, mothers and vascular surgeons. One of my mentors, Amy Reed, suggested that we form a section within the SVS to provide a more formal network of women who can help each other reach our potential. I founded this with Amy Reed, Linda Harris and Audra Duncan. We plan to hold our first session at the Vascular Annual Meeting in Boston this year.

The theme is “Supporting women vascular surgeons: from recruitment through senior leadership”. This is very special as it appeals to female surgeons in late, middle and early career, as well as those in training.

It is unique as many networking opportunities focus on the younger surgeons. This will benefit all and we will learn from each other. We hope to expand this throughout the SVS membership and already have interest from women in our international chapters.

We approach this with open arms welcoming all SVS members who want to support women in our journey towards excellence.

What are your hobbies and interests outside of medicine?

My interests include spending time with my family, skiing, exercise and travel.

Current academic and staff appointments:

Professor of Surgery, State University of New York, Syracuse, USA Professor of Emergency Medicine, State University of New York, Syracuse, USA Vascular Surgery Fellowship Program Director, Upstate Medical Center, Syracuse, USA Director, SUNY Upstate Center for Limb Preservation and Diabetic Foot,

Syracuse, USA Director, Venous Program, Upstate Medical University, Syracuse, USA

Current society positions:

Secretary General, World Federation of Vascular Societies President Elect, International Society for Endovascular Specialists Co-Chair, Women’s Section and Chair, International Relations Committee, Society for Vascular Surgery

Education and training (selected):

2001–2003: Vascular Surgery Fellowship, Newark Beth Israel Medical Center, Newark, USA 2000–2001: Research Fellowship, Montefiore Medical Center, New York, USA 1995–2000: Surgical Residency, Saint Vincent’s Hospital & New York Medical College, New York, USA

Issue 93 | March 2022

Remote Monitoring 21

Remote monitoring scheme aims to “break down barriers” to aortic care With the aim of addressing the long-term outcomes gap between patients based on their social deprivation status, Tara Mastracci (St Bartholomew’s Hospital, London, UK) tells Vascular News about the potential of a remote monitoring programme for dissection care, which is about to be launched in east London, UK.

P

ractising patient-centred care will generate “a deprived tended to be more likely to get open surgery, constellation of options for good judgement,” and Mastracci admits that it is hard to know why, but says Mastracci, who stresses in particular the otherwise the team found that the patients were treated importance of knowing the patient well enough to equally in the short term. understand their social deprivation status.

Despite these encouraging results, the team found Cardiovascular disease is skewed towards patients that mortality in the long term was much worse in who are more socially deprived, Mastracci tells patients who were more socially deprived. “That Vascular News, noting that this “very suggests a lot of things,” says Mastracci. nuanced variable” brings together all the “Perhaps health literacy is not great, perhaps social determinants of health, including these patients are not accessing the different housing, income, education, health security aspects of care that will lead to longer life, and health literacy. maybe they do not have the time or bandwidth The role of the vascular surgeon is to exercise or to do things that modify Tara Mastracci cardiovascular disease,” she speculates. vital here, according to Mastracci, as they have a “front row seat” to this patient population.

“Knowing that this was happening, even in a public She elaborates: “The Venn diagram of people who healthcare system I thought was something that needed are socially deprived and those who show up in the to be looked at and shared with my colleagues.” vascular surgeon’s office is pretty heavily overlapped.”

For this reason, Mastracci proposes that “it is probably US data “ring a lot of alarm bells” about time for us to start talking about that and actually Mastracci has also undertaken research comparing working it into our practices”. outcomes across different health care systems.

Recently, she collaborated with Miranda Witheford Long-term mortality “much worse” in (University Health Network, Toronto, Canada) to more socially-deprived patients conduct a systematic review comparing the UK and US During her time working at the Royal Free Hospital healthcare systems. She summarises the findings: “If in London, UK, Mastracci was part of a research you look at the data in some publications reported from group that took a cohort of patients and scored them American hospitals, the reporting is heterogeneous, according to their index of multiple deprivation but we do see the same impact on longevity. Added to (IMD). “What we found is that, thankfully, because that, some socially-deprived patients are more likely we have a public healthcare system [in the UK], their to present at later stages of their disease, and they are access to care was not any different,” she relays. The more likely to present ruptured.” team did notice that patients who were more socially “These data ring a lot of alarm bells to a vascular

Highlights from Critical Issues 2021 Isabelle Van Herzeele (Ghent University, Ghent, Belgium) tells Vascular News about the presentations that caught her attention at Critical Issues in Aortic Endografting 2021 (17– 18 December, Paris, France).

PROGRAMME DIRECTORS Tara Mastracci (St Bartholomew’s Hospital, London, UK) and Stéphan Haulon (Hôpital Marie Lannelongue, GHPSJ, Paris, France), supported by steering committee members Timothy Resch (Copenhagen Aortic Center, Rigshospitalet, Denmark) and Eric Verhoeven (Klinikum Nuremburg, Nuremberg Germany), put together a fantastic edition of Critical Issues in 2021.

Tilo Kölbel (German Aortic Center Hamburg, Hamburg, Germany) addressed the problem of postoperative stroke in the treatment of arch pathology, highlighting that stroke incidence is influenced by its definition and whether or not an independent neurological evaluation to detect latent

cerebral damage is being done pre- and postoperatively. He also highlighted a key question in the field: should stroke also include silent brain infarction on magnetic resonance (MR) diffusionweighted imaging (DWI) or not?

Stroke in endovascular repair of the aortic arch can be diminished by accurate patient selection, avoiding the shaggy aorta, minimising catheter/ wire manipulations, monitoring heparinisation, temporary occlusion of the carotid arteries, use of CO2 flushing and maybe by use of protection strategies, as highlighted by Richard Gibbs (Imperial College Healthcare NHS Trust, London, UK) in the imaging session, who has initiated the INTERCEPTevar trial comparing standardised saline versus CO2 de-airing techniques in thoracic endovascular aortic repair (TEVAR).

An original presentation was given

by Tara Mastracci, “Leg weakness after TAAA [thoracoabdominal aortic aneurysm] repair”, during the spinal cord ischaemia (SCI) session. She focused not only on the traditional causes of leg weakness but also on frailty, stating that this may also influence leg weakness post-repair. Prehabilitation may be the way forward, she communicated, however the jury is still out there if it does make a

surgeon who hopes to get the best outcomes, and who is focused on long-term durability. It would be good to know that the system is not working against us,” she says, “but in fact that is what the literature is showing.”

Remote monitoring will “expand traditional pathways” to care

Mastracci and a team at St Bartholomew’s Hospital are about to launch a remote monitoring programme for dissection care that she hopes will “break down the barriers to communication between the healthcare community and patients”. She details that the scheme is part of a larger suite of community-based patient care that the team is hoping to provide at the hospital.

Specifically, what the team is hoping to do is to increase the number of blood pressure measurements

The Venn diagram of people who are socially deprived and those who show up in the vascular surgeon’s office is pretty heavily overlapped.” they can see from their patients without asking them to come to the hospital. The team is launching the scheme in partnership with Ortus Health, Mastracci details, a company which has a web-based app that is developed specifically for remote monitoring.

“I am hoping that as we develop this programme, we can talk more about the lessons we learn, especially in the area of digital exclusion,” Mastracci communicates, admitting that the team is “going to get some things wrong at the beginning, but are dedicated to iterating quickly”. Looking to the future, Mastracci expresses her excitement that the team will “expand the traditional pathways for patients to reach medicine”.

difference. Mastracci added that frailty and underlying spinal damage may be related, causing muscle weakness by nervous decline and by reduced flow to the spinal cord (occluding lumbar branches and intentionally decreasing the distal aortic diameter) resulting in slow muscle wasting.

In the thoracoabdominal aorta session, Germano Melissano (Vita-Salute San Raffaele University, Milan, Italy) gave an excellent presentation entitled “How shaggy is too shaggy to treat?”. The presenter detailed that shagginess is associated with increased embolisation, SCI and infarction of visceral and renal tissues, with high morbidity and mortality rates in open and endovascular procedures. Any shagginess is shaggy and should be avoided, he concluded.

Andres Schanzer (University of Massachusetts, Worcester, USA) shared the preliminary data of the United States fenestrated/branched endovascular aneurysm repair (F/BEVAR) Aortic Research Consortium (ARC) involving 10 centres that upload their data about FEVAR/BEVAR in an electronic platform, allowing them to evaluate its use and safety in octogenarians versus non-octogenarians and the impact of preloaded F/BEVAR catheters for endovascular repair of complex aortic aneurysms. For more on this

presentation see page 15.

New this year was “My coolest case”.

I was most impressed by Giuseppe Panuccio (German Aortic Center Hamburg, Hamburg, Germany), who shared a case involving use of a suture to help with sheath orientation, based on a through-and-through technique to stabilise a sheath in branched endovascular aortic repair from the femoral access, developed by Kölbel.

In the abdominal aortic session, Mark Tyrell (Guy’s and St Thomas’ NHS Foundation Trust, London, UK) defined the large infrarenal neck (definitely >32 mm, probably >30 mm, possibly >28 mm are at risk for early failure) and suggested to only treat these in emergencies with standard devices while in elective circumstances other modalities should be used to improve the durability.

Resch conveyed the message that low-profile EVAR devices in infrarenal abdominal aortic aneurysm (AAA) repair may increase suitability, deliverability and assist with a percutaneous approach, but Isabelle Van Herzeele

March 2022 | Issue 93

22 Conference Coverage

Highlights from Critical Issues 2021 Continued from page 21

that durability is a major issue in several low-profile systems that have been redrawn from the market. He suggested not to use low-profile systems routinely, but only if indicated with close

surveillance afterwards.

In the adjuncts and toys session, the value of intravascular ultrasound (IVUS), Fiber Optic RealShape (FORS) technology (Philips) and steerable sheaths was highlighted and a novel concept in EVAR—the new “hairy” endograft with PTFE fibre strips was explained by Dominique Fabre (Hôpital Marie Lannelongue, GHPSJ, Paris, France).

Luca Bertoglio (Vita-Salute San Raffaele University, Milan, Italy) gave

an outstanding lecture about branch separation (incidence of 1–2%) in the thoracoabdominal complications session.

He explained that type IC (stent outside of target vessel) is due to planning errors, type IIIB (stent fractures) can be easily repaired endovascularly and that type IIIC (stent disconnection from the branch) may be challenging to repair and in order to catheterise the branches, bail out techniques via open surgery or CT-guided puncture may be required.

He detailed that, if branch disconnection

is associated with enlarged aortas, open conversion may be required.

Thank you Tara and Stéphan for a great edition of Critical Issues with fantastic presentations, numerous tips and tricks, incredible “coolest” cases and outstanding chairmen/women who facilitated the interactive discussions. I look forward to the next edition!

Isabelle Van Herzeele is an associate professor at Ghent University in Ghent, Belgium.

AORTIC

Collaborative effort key to investigating potential biomarker of acute aortic syndrome Research indicates that plasma desmosine has the potential to act as a biomarker of acute aortic syndrome and could, in the future, be used as a diagnostic tool for the condition in the acute setting. Presenting the findings of a British Heart Foundationfunded study at the UK Vascular Societies’ Annual Scientific Meeting (VSASM 2021; 1–3 December, Manchester, UK), Maaz Syed (University of Edinburgh, Edinburgh, UK) concluded that a multicentre, collaborative effort is needed to propel future investigation. The study, published as an abstract in Heart, was a collaborative effort between the University of Edinburgh and Anna Maria Choy’s team at the University of Dundee, Dundee, UK.

A

cute aortic syndrome “poses challenges in diagnosis, is unpredictable and is catastrophic,” Syed told the VSASM audience. It is known that patients with abdominal aortic aneurysms have raised desmosine, but, according to Syed, it has never been tested in patients with acute aortic syndrome before.

Therefore, the research team set out to compare plasma desmosine concentrations in patients with acute aortic syndrome compared to healthy controls, with the primary aim of determining whether desmosine concentrations change with respect to phase of disease.

The investigators analysed plasma desmosine concentrations in 53 patients with acute aortic syndrome and compared them to 106 controls, Syed relayed. The presenter noted that the groups were “reasonably well matched,” although patients in the acute aortic syndrome group were slightly older on average, more likely to be male and had lower blood pressures than the patients in the control group as they were on antihypertensive therapy.

“As we had hypothesised, plasma desmosine concentration was increased in patients with acute aortic syndrome compared to controls,” the presenter informed VSASM attendees. He added that this was true across all three sub-pathologies: aortic dissections, intramural haematomas and penetrating aortic ulcers.

The researchers were mainly interested in phase of disease, Syed detailed, noting that the majority of patients the team recruited belonged to the acute, subacute and chronic groups. The team started noticing a trend: “It looked like the closer you got to the event, the higher the plasma desmosine we observed”.

In light of this finding, Syed and colleagues then collected blood from the three patients who had presented with chest pain and later gone on to develop acute aortic syndrome or be diagnosed with acute aortic syndrome. “We thought that their plasma desmosine would be higher, but we were not

expecting to see such a high level,” he remarked.

The team developed a simple linear regression model to check that it was not a change in baseline

Maaz Syed at VSASM 2021

We have demonstrated not only that plasma desmosine is increased in patients with acute aortic syndrome, but that it is detectable within 24 hours of symptom onset.” demographics that was influencing the levels of plasma desmosine. “Plasma desmosine presentation had a three-fold increase compared to 106 healthy controls independent of their age, their sex and their smoking status, and this was statistically significant,” he explained.

The presenter detailed that, while the phase of disease helps clinicians work out morphologically

how the aorta is going to behave, it does not necessarily reflect the pathobiological properties of the aorta with respect to time. Therefore, the team also wanted to see how plasma desmosine concentrations differed with respect to time as a continuous variable.

One of their key findings was that plasma desmosine level peaked at presentation and gradually decreased with respect to time, but even patients who are many years out of the initial event had a raised desmosine level.

Finally, Syed and colleagues wanted to determine if plasma desmosine can influence the prediction of longitudinal outcomes. They developed another linear regression model, this time fitting aortic growth against desmosine and conventional clinical predictors. “Desmosine outperformed things like aortic diameter and the age of the dissection or the intramural haematoma,” he reported.

A possible diagnostic tool

“We have demonstrated not only that plasma desmosine is increased in patients with acute aortic syndrome, but that it is detectable within 24 hours of symptom onset,” Syed summarised, stressing that this has implications for the use of plasma desmosine as a potential diagnostic tool in the emergency department. Plasma desmosine also appears to be associated with aortic expansion independent of things like aortic diameter, the presenter added.

Discussion following Syed’s presentation delved further into the findings, with Richard Gibbs (Imperial College Healthcare NHS Trust, London, UK) keen to know if the researchers had data on plasma desmosine levels in patients with connective tissue disorders. Syed noted that in the one patient they assessed who had Marfan syndrome, the team noticed a five- to six-fold increase in his plasma desmosine. Two weeks later, the patient developed a dissection. “It is very hard to capture something like this, we were lucky,” the presenter commented, “but it was findings such as this that made us think maybe this is an important biomarker in patients with acute aortic syndrome, and we are now systematically testing plasma desmosine in patients with connective tissue disorders for that reason.”

Closing his presentation, Syed was keen to emphasise the importance of the research. He explained that when the findings were published earlier this year, the team was approached by the Aortic Dissection Charitable Trust. “The trust was set up in 2015 by a group of MPs who had sadly experienced loss of life in young members of their families due to this catastrophic disease, and one of the benefits of presenting research such as this in this forum is that we can gauge interest among the vascular community in developing a biomarker to diagnose acute aortic syndrome and improve risk stratification”. He continued: “Clearly, work needs to be done to take this forward, and that is going to require a multicentre, collaborative effort.

March 2022 | Issue 93

24 Hot Topics

New recommendations promote “appropriate and effective” use of social media in medicine In response to a rapid augmentation of social media use in medicine over the past five years, the Society for Vascular Surgery (SVS) has published a set of recommendations on appropriate practice. The document aims to provide guidance on “how to interact online in a transparent, collegial and ethical manner while all along protecting patient privacy,” Nicolas J Mouawad (McLaren Health System, Bay City, USA) tells Vascular News. In this interview, Mouawad and joint first author Edward D Gifford (Hartford HealthCare, Hartford, USA) outline the paper’s key messages, detail how COVID-19 has “catapulted” the use of virtual communication, and consider how the use of social media in medicine might evolve.

What are the key takeaway messages from the new recommendations document?

NM: The SVS is committed to supporting the appropriate and effective use of social media through honest, transparent and well-informed content.

The Young Surgeons Committee of the SVS convened a diverse writing group of SVS members in different practice patterns and employment models, geographic locations, cultural backgrounds and clinical experiences to help craft a document to help guide both novice and experienced users to the use of social media platforms in vascular surgery. Key takeaway messages in a nutshell are (1) absolutely protect patient privacy, (2) obtain consent when using and sharing images, (3) ensure you follow your institution’s requirements, (4) disclose conflicts of interest, and (5) maintain an amicable and professional online environment as there are multiple specialties involved in vascular care.

EG: Adding to that, social media is a great melting pot of different medical specialties. We have a lot we can learn from each other, and while we may not always agree on a case that is shared, we wanted to advocate for trying to find common ground where possible while avoiding ad-hominem attacks or other cyber-bullying behaviour.

What do you think are the main benefits and drawbacks of social media in medicine?

NM: Social media is a powerful tool to disseminate information, educate patients and providers, and allow for exchange of ideas, resources and knowledge, literally at the recipient’s fingertips. However, with this great ability comes responsibility and

accountability. I believe the main benefit is the ease of information transmission and the ability to learn and network from other healthcare professionals that you may have never interacted with or been able to reach. The drawbacks in my mind are how to ensure the credibility of the information (to minimise the spread of disinformation) and the legitimate concern for breaching patient privacy.

We must protect that at all costs!

Furthermore, users of social media must be reminded that the information does NOT constitute medical advice— patients must consult their healthcare provider.

EG: Social media can pull us out of our medical comfort zone. Often new technology or procedures are limited to vascular surgery. For instance, at an endovascular-focused conference we might be exposed to novel therapeutic options. By comparison, how often do we find ourselves at a plastic surgery or orthopaedic trauma conference?

Social media brings data from those specialties that might be very relevant to our field right to our fingertips. Take for instance the use of piecrusting to allow for delayed primary closure of fasciotomy incisions. This technique was

popularised on social media by Yelena Bogdan, an orthopaedic trauma surgeon.

However, it has now been shared among many vascular surgeons on social media, and we in our group have even used it with success after learning about it online. The rapid dissemination of information and the ability to interact with other specialists in real-time can have a real positive impact on how we practice both the art and science of medicine. Of course, this is tempered with some legitimate drawbacks. First and foremost, in my opinion, is the risk to patient privacy. Just as the reach of social media goes well beyond that of a traditional lecture hall, so too does our use of an illustrative case run the risk of violating a patient’s privacy. We must make sure we look before we leap, and when in doubt, we always err on sharing as little specific information as possible.

Why do you think it was necessary to produce such a document and at this particular time?

NM: Vascular surgeons are at the cutting edge of new technology and devices and are very tech savvy. It is no surprise to me that most are very active on social media already. The idea was borne of the Young Surgeons Committee

Nicolas J Mouawad

of the SVS and really was focused on providing guidelines on how to interact online in a transparent, collegial and ethical manner while all along protecting patient privacy. In addition, I really do believe that COVID-19 catapulted our use of social media in an effort to maintain physical distancing and

Vascular surgeons are at the cutting edge of new technology and devices and are very tech savvy.”

other public health parameters.

EG: That is a great question, and I think it is important to keep in mind that the presence of vascular surgery and vascular surgeons on social media has changed a lot from when we first contemplated this document. The idea for this sprang from the SVS Young Surgeons Committee. We noticed that more and more vascular surgeons were using social media, in particular Twitter. Personally, as a young member of that group, I was looking for some guidance about how to deal with some of the conflicts mentioned above. Could I share images of an interesting case?

What is the best way to go about doing that? We also felt that social media was a great medium to interact with trainees or medical students who might be interested in vascular surgery, but maybe did not have access to a large vascular surgery interest group at their home institution. As COVID-19 encouraged online interaction for many of us, we felt that the SVS taking a positive stance on social media use was more important than ever.

How do you think social media use in medicine has changed in the COVID-19 era?

Edward D Gifford

NM: COVID-19 has forced us to practically move and live online. It has been very challenging in the beginning months but we have found that although we are socially distant we have never been closer. The world has become even smaller with us able to communicate with colleagues internationally, learn from them as they learn from us depending on what COVID-19 wave is occurring and where. Social media during the COVID-19 era allowed us to build new friendships and foster new relationships that continue strong. As a matter of fact, some of us on this social media writing group have actually never even met each other in person! We have communicated over social media and electronically to complete the guidelines and have e-met online! I am very much looking forward to meeting everyone

Issue 93 | March 2022 in person when it is safe to do so. But social media is here to stay!

EG: Almost two years into COVID-19, it is impossible to not have days where we feel isolated. A lot of this was heightened early in the pandemic when we could not rely on in-person meetings to connect with trainees, peers, and mentors. Social media was a great forum to bring many of us together. Online we have been able to interact with vascular surgeons and other healthcare workers from around the country and the world, and we have built some truly worthwhile connections along the way. I love seeing colleagues share everything from a new community initiative on limb salvage, to how to tackle large varicose veins after ablation, to Play-Doh vascular anatomy.

Now that at least some in-person meetings have resumed, it’s great to finally meet these people in person. However, I am hopeful that the online vascular surgery community will continue to grow on in the future.

Image courtesy of Cook Medical

How do you think the use of social media in medicine might evolve in the future?

NM: Social media will continue to evolve, there is no doubt in my mind. We have seen how meetings have moved virtual as well as full annual conferences. Applicants and interviews are being conducted this way nowadays for ease of access and cost savings as well as online open houses for candidates.

Even interest groups are becoming well developed online. This, in my opinion, is an excellent opportunity to advertise to the younger generation and literally show them

Hot Topics 25 with images and videos our specialty of vascular surgery. But with more online activity, I am proud that the SVS has taken a proactive lead on this topic and am grateful to have coauthored and developed these guidelines with such a fantastic and diverse writing group of SVS members.

EG: I think certain things adopted during the pandemic may be here to stay, at least in one form or another. Take for instance the virtual interview process of our residency and fellowship applicants. There will likely be some virtual component to application season in perpetuity. Whether this is a virtual open-house to learn about a programme, faculty vignettes, or online journal-clubs, I think we are going to see use of social media for these group endeavors increase. While I hesitate to say that we are going to be providing patientspecific medical care on social media, we are already seeing community education events via social media forums such as Facebook live. The reality is that a lot of our patients use social media. If we want to provide factual education about vascular disease to them, social media might provide a lot of opportunity for that. Lastly, as we anticipate the intersection of social media and medicine growing, this may result in some form of oversight or regulation.

To that end we are grateful to the writing group members and the SVS for backing sensible and thoughtful recommendations that make Graphic our social media use as a representation specialty more impactful. of BTK intervention

Cook Medical receives FDA breakthrough designation for new drug-eluting stent COOK MEDICAL HAS RECEIVED Breakthrough Device designation from the US Food and Drug Administration (FDA) on a new drug-eluting stent for below the knee (BTK). This new stent is designed to treat patients suffering from chronic limb-threatening ischaemia (CLTI).

“CLTI is a debilitating disease of growing prevalence around the globe and this is Cook Medical’s latest innovation within our peripheral arterial disease (PAD) programme,” said Mark Breedlove, vice president of Cook Medical’s Vascular division.

He continued: “This new product leverages our deep understanding of stent design and drug elution for lower limb anatomies, and it complements our dedicated portfolio of BTK products for limb preservation. Our goal is to improve the long-term clinical outcomes for CLTI patients.”

The Breakthrough Device designation is granted for devices that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions.

While the product is not commercially available yet, the benefits of the designation include priority review and interactive and timely communication with FDA during the clinical trial and premarket review phases in order to help get lifesaving devices to patients more quickly, a Cook Medical press release details.

March 2022 | Issue 93

26 New Guidelines

VENOUS

ESVS CVD guideline writing committee “entirely renews structure” of recommendations The European Society for Vascular Surgery (ESVS) has released 2022 clinical practice guidelines on the management of chronic venous disease (CVD) of the lower limbs. Writing committee chair, Marianne G De Maeseneer (Erasmus Medical Centre, Rotterdam, The Netherlands) outlines the central takeaway messages from the paper, published in the European Journal of Vascular and Endovascular Surgery (EJVES), and highlights what is new in the 2022 guidelines compared with the 2015 recommendations.

What are the key takeaway messages from these new recommendations?

The new ESVS guidelines document contains 94 recommendations (of which 65 are new). These should help the physician to make appropriate decisions for / together with an individual patient with CVD. Obviously there are many new recommendations of interest. For instance, abdominal duplex ultrasound should be considered in patients with suspected supra-inguinal pathology, as part of the initial assessment. Whereas not all patients with CVD and superficial venous incompetence require interventional treatment, in those presenting with symptomatic varicose veins with or without oedema (CEAP clinical class C2s, C2,3s) and those with skin changes, including healed or active venous leg ulcer (CEAP clinical class C4– C6), intervention is recommended. The important role of endovenous thermal ablation (EVTA) for treating superficial vein incompetence has been confirmed, while several non-thermal techniques have now become available: the use of cyanoacrylate glue should be considered and other techniques, like ultrasound guided foam sclerotherapy, catheter directed foam sclerotherapy and mechanochemical ablation, may be taken into consideration, always as part of a shared decision-making process between the patient and the handling physician. Patients with iliac vein outflow obstruction requiring intervention should be treated by a multidisciplinary team and endovascular intervention (stenting) should be considered, as the first choice treatment.

For patients with venous leg ulceration, early endovenous ablation is recommended to accelerate ulcer healing and reduce recurrence. Finally, for women with symptomatic varicose veins of pelvic origin without pelvic symptoms (such as chronic pelvic pain, dyspareunia etc.) the first choice treatment to be considered consists of local procedures for varicose veins and pelvic escape points and hence embolisation should not be part of the initial treatment.

Why are these guidelines important?

As the literature search for the 2015 document had been performed only The importance of these guidelines until 1 January 2013, many new lies in the original approach, as publications including several we have put the patients suffering randomised clinical trials (RCTs), from CVD at the very centre systematic reviews and metaof our attention. You will see analyses were available for that any management strategy analysis of the evidence (until in the guidelines document (e.g.

June 2021). For EVTA of the great diagnostic pathway, conservative saphenous vein, evidence of its management strategy, interventional beneficial outcome is now available treatment options…) starts with ‘Patients after a follow up of more than 5 years, with…’ which will help the handling with a maintained positive effect on Marianne G De physician to make the right decisions, in clinical outcome (r-VCSS, revised venous Maeseneer agreement with the patient’s values and clinical severity score) and quality of life, preferences. When we had our ‘kick off’ meeting equal to high ligation and stripping (the latter causing (Amsterdam, November 2019), together with Stavros more postoperative complications and needing a Kakkos, my co-chair, and 15 more members of a longer recovery/days off work). For cyanoacrylate multidisciplinary guideline writing committee, there adhesive closure, the first five-year extension study was a general agreement that every chapter of the of the VeClose RCT, comparing cyanoacrylate glue guidelines should end with a strategy subsection, with radiofrequency ablation, has been published in illustrated with a clear flowchart. We eventually 2020. For mechanochemical ablation, a RCT with managed to summarise the most appropriate three years follow up is now available (Vähäaho et management strategies in a way they will really be al, 2021). A recent meta-analysis, performed by useful and applicable in daily clinical practice. the youngest member of our writing committee (Aherne et al, 2020) lead to the recommendation to

What are the main updates from the 2015 document?

First of all, these 2022 ESVS guidelines are much more than just an ‘update’ of the previous edition of the ESVS CVD guidelines and almost nothing was copy-pasted from the previous edition. From the very beginning, the guideline writing committee decided to entirely renew the structure of the guidelines document, not subdividing the guidelines according to the available techniques, but focusing on the particularities of the patients to be treated.

This resulted in a separate chapter about patients with superficial venous incompetence (including

Many new publications including several randomised clinical trials, systematic reviews and meta-analyses were available for analysis of the evidence.” perforating vein incompetence and recurrent varicose veins), a separate chapter about patients with symptoms and signs of deep vein obstruction (and some other deep venous pathology), another chapter entirely dedicated to patients with venous leg ulcers (in contrast to the previous edition, where this information was scattered throughout the document), then a chapter focusing on mainly female patients with varicose veins related to underlying pelvic vein incompetence (which were hardly mentioned in the previous edition), to end with a chapter containing some special considerations, about acute complications in CVD patients and about treatment of patients with special characteristics, such as obese patients, pregnant women, those chronically anticoagulated and elderly patients with comorbidities.

We come across all these patients a lot in our daily phlebological practice and therefore they became part of the 2022 guidelines document.

Which new data have informed these updated guidelines?

Top: The writing committee discusses the first draft of the recommendations in Frankfurt, September 2020 Above: The writing committee attends a ‘kick-off’ meeting in Amsterdam, November 2019

consider concomitant tributary treatment in patients with an incompetent saphenous trunk treated with EVTA or non-thermal ablation. The results of endovascular treatment (stenting) of CVD remain difficult to interpret, categorise and appraise because of large heterogeneity across trials and reports, as has been concluded in several systematic reviews. There is only one small RCT comparing iliac vein stenting with medical treatment available to date (Rossi et al, 2018) Nevertheless, most studies support a role for venous stenting in properly selected patients. Finally, an important trial in the management of venous leg ulcers has been published by one of our writing committee members, the EVRA trial, which proved that early endovenous ablation (within two weeks) for treating saphenous trunk incompetence accelerates ulcer healing and reduces ulcer recurrence (Gohel et al, 2018 and 2020).

Issue 93 | March 2022

Journal Highlights 27

VENOUS

Risk of venous stent migration rare but probably underreported, systematic review finds Stent migration following treatment of acute iliofemoral thrombus or venous obstruction is “rare but may be underreported”, with the majority of reported cases being shorter and smaller diameter stents. This is the main concluding finding of a systematic review published in the Journal of Vascular Surgery: Venous and Lymphatic Disorders.

AUTHORS MOHAMED HOSNY Sayed (Guys & St Thomas’ NHS Foundation Trust, St Thomas’ Hospital, London, UK) and colleagues note that little research is available on percutaneous endovenous stenting—the primary treatment for acute iliofemoral thrombus or venous obstruction. In order to address this paucity in the literature, Sayed et al carried out a systematic review, with the specific aims of identifying the number of cases reported in published literature, as well as recognising associated risk factors and outcomes of venous stenting.

Following data collection, the

researchers included cases between 1994 and 2020 in their review. Sayed and colleagues reveal that a total of 31 articles, consisting of 29 case reports and two case series, provided data for 54 reported events of venous stent migration. Of these 54 cases, only 47 provided details on the size of stent used. The average age of the patients in whom stent migration was reported was 50 years (range 19–88), and 57.6% (n=30) of the cohort were male. The authors also relay that, in 85% of the migrated stent events, retrieval was attempted with 56% via an endovascular approach. In these

Blueflow venous stent for chronic iliofemoral venous disease “offers favourable primary patency” DEEP VENOUS STENTING WITH THE Blueflow venous stent (Plus Medica) offers favourable primary patency, and is associated with significant continued improvement of symptom severity in patients with obstructive chronic venous disease (CVD) out to 12 months. Michael Lichtenberg (Vascular Center Arnsberg, Klinikum Hochsauerland, Arnsberg, Germany) et al note this was the main finding of a recent observational, single-centre study published in Vasa: the European Journal of Vascular Medicine, however, the authors suggest that future prospective research on long-term stent patency is required.

In patients with thrombotic or non-thrombotic obstruction, CVD is common following anticoagulation. Post-thrombotic syndrome is a common complication of this, with approximately two-thirds of iliofemoral thrombosis cases presenting due to extrinsic compression of the left-sided iliac vein, known as May-Turner syndrome. In current practice with patients presenting iliofemoral deep vein thrombosis (DVT), anticoagulation does not resolve the occlusive thrombi or prevent postthrombotic syndrome, despite 100 per 100,000 patients experiencing diagnosis. In light of this, Lichtenberg et al therefore aim to evaluate the effectiveness and safety of the Blueflow venous stent, for the treatment of venous outflow obstruction.

This observational, single-arm, single-centre study, set out to recruit adults (over the age of 18), with symptomatic, non-malignant, non-thrombotic

cases, immediate outcome was reported to be 100%, regardless of retrieval approach, however, Sayed et al point out that stent migration could result in immediate death, which precluded attempts at retrieval. The review found that no migrated stents were reported to be larger than 100mm in length, with 38 out of 46 (82.6%) reported to be less than 60mm, and only 3.6% of reported migrations involved stents greater than 14mm in diameter.

Sayed and colleagues conclude that venous stent migration appears to be a rare complication of venous stenting, however, when it does occur,

Clear strategies to avoid migration need to be followed to prevent this complication occurring.”

chronic vein lesions (NIVL) or post-thrombotic venous obstruction (PTO) of the iliofemoral vein segment. These patients received Blueflow venous stent implantation, and it was noted that all patients received periprocedural and postinterventional anticoagulation. The authors also note that patients with venous obstruction proximally from the common iliac vein (CIV) and prior venous stent implantation were excluded from the study.

Lichtenberg and colleagues, report primary patency and clinical improvement as the effective outcomes of this evaluation. In this case, primary patency at 12 months was defined as the cumulative incidence of patients, with the absence of less than 50% diameter obstruction of the treated segment, and modulated venous flow without prior surgical or endovascular recanalisation. The authors also describe that clinical improvement of symptoms were reported using the revised venous clinical severity score (rVCSS) and the comprehensive classification system for CVD—CEAP (clinical findings, etiological factors, anatomical cause, pathological cause) clinical score. The study’s safety outcomes, were characterised as recurrent DVT, major bleeding events, clinically driven target vein revascularisation, and index limb major amputation or death.

The authors note that from the period of February 2018 to March 2019, a total of 67 patients with iliofemoral chronic venous outflow obstruction were recruited, consisting of 50.7% females, aged 46±18.1 years. A total of 21 (31.3%) patients presented with NIVL—of which the Blueflow venous stent was fitted in the common iliac vein with extension into the inferior vena cava. Of the patients with NIVL, the average age was 47.3±19.7 (p=0.43), consisting of 17 (81%) females (p=0.001). In addition, 37 (55.2%) of patients demonstrated PTO, consisting of 15 (40.5%) females, with the average age of 42.0±15.5 (p=0.43). The authors also highlight that six-month follow-up was completed in 33 (49.3%) patients, with 12-month follow-up completed across 34 (50.7%) patients.

has the potential to cause “significant morbidity and mortality”. The data also suggest that migration is more likely to occur with shorter length (≤60mm) and smaller diameter (≤14mm) stents, with the combination being the most common. “This adds weight to the significant role that appropriate sizing of stents in treatment may play in preventing this catastrophic complication,” senior author Stephen Black (St Thomas’ Hospital, King’s College London, London, UK) remarks.

Sayed and colleagues write that “more formal data collection would provide a truer reflection of incidence,” especially given that this complication is “undoubtedly underreported”, according to Black. They highlight that the data retrieved for this review were of too low quality for meaningful statistical analysis. However, the researchers also stress that “clear strategies to avoid migration need to be followed to prevent this complication occurring”. This is “strongly related” to training and education, says Black, which he believes “may help prevent patients coming to harm”.

Lichtenberg et al describe that a large majority of patients (76.1%) presented a history of previous venous thrombotic disease—of these patients, 97.3% illustrated PTO, compared to 57.1% of patients with NIVL (p<0.001). In respect to patient history, 21.9% were previous or current smokers, 2.4% had hypertension and 17.9% had a history of cancer.

Following analysis, it is noted that the median rVCSS score was 8, with median CEAP at 3. In patients with PTO, CEAP class larger than five was more common in comparison to NVIL patients, at 26.5% vs. 4.8% (p=0.04) respectively.

At six-month follow-up, and 12-month followup, 91.7% and 79.8% of patients presented primary patency of the target segment, respectively. The authors highlight that the average survival time of patients did not differ significantly between both NIVL (357 days) and PTO (422 days) patients (p=0.14). Additionally, at 12-month follow-up, a total of 11 patients presented significant limb-based venous outflow obstruction larger than 50 percent— nine of these were receiving anticoagulation during this period. Symptomatic improvement held no association to thrombotic condition at both baseline or stent extension. Furthermore, the authors report that during follow-up, six vein re-interventions were performed, with no major target limb amputation or deaths recorded.

The authors mention several limitations to the study, such as the inability to quantify the effectiveness of the novel braided stent effectiveness due to having no comparator. The patient range of characteristics, such as clinical severity, anatomic extent and DVT duration are suggested to have potentially interacted with the treatment effect, however, this was not possible to determine without a control group and appropriate power.

Michael Lichtenberg

March 2022 | Issue 93

28 Journal Highlights

CAROTID

Expedited carotid artery surgery after index event “probably safer” than expedited stenting A systematic review and metaanalysis of 71 studies suggests that, at present, carotid endarterectomy (CEA) is safer than carotid artery stenting (CAS) when performed within two or seven days of the index event. “The findings of this analysis will guide clinical practice when deciding on the type of intervention in the symptomatic patient with severe carotid stenosis,” authors Andreia Coelho (Centro Hospitalar Universitário de Porto, Porto, Portgual) et al write in the European Journal of Vascular and Endovascular Surgery (EJVES), where the findings were published as an Editor’s choice paper.

Coelho et al stress that the ideal timing of performing CAS in symptomatic patients, when indicated against CEA, is not yet defined.

E

uropean Society for Vascular Surgery (ESVS) guidelines advise that CEA or CAS should be performed within 14 days of symptom onset, the authors communicate. However, they note that the evidence would suggest there has been a drive towards performing interventions well within 14 days, especially in Europe. In addition, they write that a temporal trend towards a progressive decrease in delays from index event to undergoing CEA or CAS has been reported in several national

registries. However, mixed findings about the impact significantly higher mortality rate (OR, 2.76; 95% CI, of intervening within 48 hours of index event have 1.39–5.5). been reported, Coelho et al stress.

Coelho and colleagues write that there were In order to analyse the timing of carotid inconsistent findings regarding timing and outcomes in interventions after index event, as well as 30-day CAS patients. They elaborate: “In patients undergoing outcomes at varying time periods within 14 days of CAS ≤2 days of the index event (vs. 3–14), there symptom onset, the investigators initiated a systematic was no apparent different in 30-day stroke or MI review and meta-analysis of the available data. [myocardial infarction] but there was a statistically Coelho and colleagues first performed a systematic significantly higher risk of death. Conversely, there review, involving an online search of the Medline and were no differences in 30-day outcomes between Cochrane databases. Endpoints included procedural CAS performed ≤7 days (vs. 8–14).” The authors stroke and/or death stratified by delay from the index hypothesise that the pathophysiology of procedural event and surgical technique, they convey. stroke may differ with expedited, versus delayed, The investigators included 71 studies with interventions in line with acute changes in The 232,952 symptomatic patients. They detail that atherosclerotic plaque vulnerability, which investigators have been associated with an increased risk of the 71 studies comprised of 34 retrospective databases, nine prospective, three embolism and neurological events after included randomised controlled trials, CAS. three case-control, and 22 The investigators also retrospective studies. address some limitations of Writing in EJVES, Coelho et the studies included in their al report that CAS was analysis, including that fact associated with higher 30-day that the studies analysed are symptomatic stroke (odds ratio [OR], 0.7; of moderate to low quality. studies patients 95% confidence interval [CI], In addition, they state that 0.58–0.85) and mortality rates (OR, “probably one of the main biases” 0.41; 95% CI, 0.31–0.53) compared in the study was introduced in the with CEA when performed within two days of election for CAS/CEA, with fit patients treated symptom onset.

by CEA while high-risk patients were treated by The research team analysed patients CAS. undergoing CEA/CAS in different time The data suggest that, at the current time, frames: ≤2 vs. 3–14 and ≤7 vs. 8–14 CEA is “probably safer” than CAS when days, which revealed that expedited performed within two or seven days after CEA (vs. 3–14 days) presented a symptom onset, the authors conclude. sampled 30-day stroke rate of 1.4%; Considering the wider topic area, they 95% CI, 0.9–1.8 vs. 1.8%; 95% CI, add that no studies have published 1.8–2, with no statistically significant outcome data for transcarotid artery difference. Expedited CAS (vs. 3–14 revascularisation (TCAR) when used in days), they note, was associated with no the first 14 days after symptom onset as of Andreia difference in stroke rate but statistically yet, and that these data are “keenly awaited”.

Coelho

Women face increased risk of stroke and readmission after carotid interventions A RECENT STUDY HAS pointed to an increased risk of stroke in both asymptomatic and symptomatic female patients, as well as readmission in asymptomatic female patients following carotid endarterectomy (CEA) or carotid artery stenting (CAS). These findings were published online ahead of print in the Journal of Vascular Surgery (JVS).

Authors Steven Goicoechea (Loyola University Medical Center, Chicago, USA) and colleagues write that, historically, CEA has illustrated a higher rate of perioperative adverse events for female patients. Despite this, they note that recent research portrays evidence to suggest similar outcomes following CEA between female and male patients. In contrast, however, they stress that few studies have examined sex differences in CAS. In order to address this gap in the literature, Goicoechea et al prospectively collected contemporary data from

the American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) database, and performed a retrospective cross-sectional review.

The research team collected data from adult patients (n=106,658) who had undergone CEA (n=104,412) or CAS (n=2,156) in the period 2005– 2017, they communicate in JVS. The study’s primary outcomes of interest were 30-day postoperative adverse outcomes in asymptomatic versus symptomatic and female versus male patients, who had undergone CEA or CAS. Among the asymptomatic group—in which nearly 60% of patients were male—female sex was associated with significantly higher rates of cerebrovascular accident (CVA; 32%, p=0.034), bleeding complication (203%, p=0.001), and urinary tract infection (70%, p=0.011) compared to male sex, the authors write.

71 232,952

Goicoechea and colleagues add that female sex was also associated with a lower rate of pneumonia (39%, p=0.039) and that female patients less than 75 years old illustrated increased rates of CVA (21%, p=0.001) and readmission (15%, p<0.001) compared to male patients, whereas this was not the case in female patients aged 75 years and older. Lastly, in both asymptomatic and symptomatic patients who received CEA, female patients had significantly higher rates of CVA (13% p=0.006 and 31%, p=0.044), however, these findings were not found in patients undergoing CAS. In the discussion of their findings, Goicoechea et al write that the current study highlights sex disparities

Women and ethnic minorities have historically been underrepresented in vascular surgery randomised controlled trials.”

in vascular surgery, including discrepancies in postoperative outcomes and complications that have previously been established. They detail that women and ethnic minorities have historically been underrepresented in vascular surgery randomised controlled trials (RCTs), especially in non-governmental and single-centre trials, commenting that this underrepresentation leads to under-reporting of potentially significant differences in outcomes between male and female patients.

Also in their discussion, the authors note that their study is limited by certain factors, including the use of retrospective data from an administrative dataset with potentially missing information, and difficulty identifying causes of discrepancies in female versus male outcomes due to a “lack of granularity” in a large database such as NSQIP. In concluding, Goicoechea and colleagues stress that the present study emphasises the importance of understanding sex disparities in surgical management of cerebrovascular disease, and stress that RCTs must ensure adequate representation of female patients in order to better understand these differences.

Issue 93 | March 2022

Journal Highlights 29

Study highlights need to extend scope of cerebrovascular health disparities research A new research letter in Stroke outlines use of the novel National Institutes of Health (NIH) ‘All of Us’ research programme dataset of diverse participant data to identify factors that increase the risk of carotid artery stenosis and those who undergo revascularisation. The study, authored by Daniela Renedo (Yale School of Medicine, New Haven, USA) and colleagues, includes electronic health record data from over 200,000 US patients.

“IT IS INCREASINGLY recognised that underrepresented groups defined by factors other than race and ethnicity also carry a disproportionate burden of cardiovascular disease,” the authors begin. In order to test the hypothesis that the burden of carotid artery stenosis and the proportion of persons who undergo carotid revascularisation differ in broadly defined underrepresented groups, the researchers utilised data collected via the ‘All of Us’ research programme.

According to the NIH website, the ‘All of Us’ research programme is inviting one million from across the USA “to help build one of the most diverse health databases in history,” welcoming participants from all backgrounds. “Researchers will use the data to learn how our biology, lifestyle, and environment affect health,” with the ultimate aim of finding ways to treat and prevent disease, the website adds.

The team performed a cross-sectional study including ‘All of Us’ participants with available electronic health records

data, considering underrepresented groups defined by factors other than race and ethnicity, including education (less than high school degree); income (less than $35,000); and gender identity/sexual orientation.

Of the 203,813 patients included in the study, the average age was 51.5 years and the majority (61%) were female. The authors relay that the prevalence of carotid artery stenting was 2.7% (n=5,420) and the proportion of patients who underwent carotid revascularisation was 7.3% (n=395).

Writing in Stroke, Renedo et al report a key finding that persons with income of less than $US35,000 were more likely to have both carotid artery stenosis and undergo revascularisation, detailing that income of less than $US35,000 was associated with higher odds of carotid artery stenosis (odds ratio [OR], 1.15 [95% confidence interval (CI), 1.07–1.24; p=0.001] and carotid revascularisation (OR,

1.38 [95% CI, 1.04 – 1.83]; p=0.024).

The investigators also found that, when evaluating underrepresented groups defined by race and ethnicity, Black (OR, 0.87 [95% CI, 0.78–0.96], p=0.006) and Hispanic participants (OR, 0.83 [95% CI, 0.73–0.94] had a lower prevalence of carotid artery stenosis, which they note is consistent with prior reports.

Moreover, the authors communicate that Black participants with carotid artery stenosis (OR, 0.41 [95% CI, 0.24–0.68]; p=0.001) had lower estimates of carotid revascularisation.

This could be explained by lower rates of high-grade stenosis, they remark, but stress that other factors should be explored further, including the potential presence of care access bias.

Renedo and colleagues acknowledge that their study may be subject to volunteer bias, leading to an increased number of healthy people enrolled.

In addition, they note that not all participants chose to share their electronic health records.

“These results highlight the need to extend cerebrovascular health disparities research beyond groups defined by race/ethnicity,” the researchers conclude, adding that this goal will be “significantly facilitated” by the newly established ‘All of Us’ research programme.

Speaking to Vascular News, Renedo conveys the key takeaway message

Worldwide TCAR analysis provides “roadmap” to evaluate future training approaches

Daniela Renedo

from the study, that more attention should be given to the present healthcare disparities in this condition.

“Clinicians should be aware of these disparities, and offer patient-centred recommendations to prevent, mitigate and manage carotid artery stenosis across diverse populations,” she elaborates.

The first author advises that, in the near future, the ‘All of Us’ research programme will provide access to genetic data from the participants.

Renedo is part of a lab team at Yale headed by Guido J Falcone that is

Clinicians should offer patient-centred recommendations to prevent, mitigate and manage carotid artery stenosis across diverse populations.” focused on genetic epidemiology, and therefore the team will use the data from this study “to better understand the interaction between social determinants of health and biological factors that ultimately lead to carotid stenosis and its consequences.”

Charles C Matouk jointly supervised the work with Falcone.

asymptomatic carotid stenosis and had more prior experience with transfemoral carotid stenting, the researchers specify.

Writing in JVS, the authors report that the over 24-hour composite clinical adverse event rate (1%; 95% confidence interval [CI], 0.8–1.3%) and composite technical adverse event rate (6%; 95% An analysis of the worldwide experience of transcarotid artery revascularisation CI, 5.4–6.6%) did not differ significantly by training (TCAR) has produced key objective proficiency metrics and an analytic framework mode. In addition, they relay that the proficiency to assess adequate training for the procedure. “Training on cadavers or synthetic measures of cadaver-trained and synthetic modelmodels achieved clinical outcomes, technical outcomes and proficiency measures trained physicians “were not inferior to those for for subsequently performed TCAR procedures similar to those achieved with training the proctored physicians”. The team identified four using traditional proctoring on live cases,” Brajesh K Lal (University of Maryland, key proficiency measures for TCAR, namely the Baltimore, USA) and colleagues conclude in the Journal of Vascular Surgery (JVS). mean contrast volume used during the procedure, the fluoroscopy time required for imaging, the CAR is a new hybrid approach to adverse event rates between the procedures duration of carotid artery flow reversal, and carotid artery revascularisation,” the performed by physicians after undergoing the total skin-to-skin time. authors begin. They note, however, the three training modes and tested whether The authors recognise certain limitations that proctored training on live cases is an “effort-, the proficiency measures achieved during of the present study. The retrospective nature time-, and resource-intensive approach to learning TCAR after training on cadavers and of the analysis was subject to selection bias, new procedures.” Against this backdrop, Lal et al synthetic models were non-inferior to they acknowledge. However, they stress analysed the worldwide experience with TCAR proctored training. that the clinical and technical composite Brajesh K Lal to develop objective performance metrics for the Lal et al communicate that, in the period outcomes were similar to those reported procedure and compared the effectiveness of training 3 March 2009 to 7 May 2020, 1,160 from prospective studies. Another limitation physicians using cadavers or synthetic models to physicians underwent proctored (19.1%), cadaverthey highlight was the fact that trainees were not traditional in-person training on live cases. based (27.4%) and synthetic model-based (53.5%) randomised to the three study groups nor to a no The researchers describe how physicians TCAR training and subsequently performed 17,283 training control group. underwent one of three mandatory training TCAR procedures. “The present study is one of the Lal and colleagues conclude that the analytic programmes: (1) in-person proctoring on live TCAR largest to analyse the clinical and technical outcomes approach outlined in their paper provides a procedures; (2) supervised training on human stratified by training mode,” the authors note in the “roadmap” to evaluate the effectiveness of training cadavers; and (3) supervised training on synthetic discussion of their findings. The proctored physicians approaches for new technologies and surgical models. Lal and colleagues then compared the treated younger patients and more patients with techniques in the future.

“T

March 2022 | Issue 93

30 Market Watch

Clinical News is fortunately widely accepted by study patients as the recruitment status demonstrates.”

Teichgräber adds: “I am convinced that SIRONA represents a gamechanging trial for PAD.”

New publication “extends evidence for clinical benefit” with CytoSorbents’ haemoadsorption technology into type A dissection aortic surgery Concept Medical lights up NASDAQ in New York’s Times Square to celebrate the SIRONA trial achieving 50% enrolment

SIRONA head-to-head randomised trial achieves 50% enrolment

Concept Medical recently announced that the SIRONA randomised controlled trial (RCT)—a head-to-head comparison of sirolimus versus paclitaxel drugeluting balloon angioplasty in the femoropopliteal artery—has completed half the targeted enrolment.

According to a company press release, SIRONA is the world’s first and largest head-to-head RCT investigating the use of a sirolimus drug-coated balloon (DCB; Magic Touch PTA, Concept Medical) vs. a paclitaxel DCB (CE-certified devices) for the treatment of femoropopliteal occlusive artery disease.

The investigator-initiated and -driven trial, led by Ulf Teichgräber (Jena University Hospital, Jena, Germany) aims to evaluate the safety and efficacy of a sirolimus DCB against a paclitaxel DCB in stenosed or occluded lesions in the superficial femoral artery (SFA) and/or popliteal artery in peripheral arterial disease (PAD) patients with Rutherford class 2–4.

Marianne Brodmann (University of Graz, Graz, Austria) enrolled the 239th patient on 23 November 2021, making the trial halfway towards its target of enrolling 478 patients set to be randomised in 1:1 fashion across 30 sites in Germany and Austria.

Thomas Zeller, site investigator of Universitäts-Herzzentrum Freiburg in Bad Krozingen, Germany, expresses his thoughts on the importance of the trial: “The SIRONA trial substantially contributes to evaluating the effectiveness of an alternative antiproliferative coating (sirolimus) for balloon catheters to treat femoropopliteal stenoses and occlusions compared to the current gold standard of a paclitaxel coating.

Especially with regard to the still ongoing safety discussion, SIRONA represents the first head-to-head comparison and therefore is of high scientific and clinical relevance, and

CytoSorbents has called attention to a new publication which reports on the use of intraoperative haemoadsorption using the company’s technology to reduce perioperative bleeding complications in patients with acute type A aortic dissection who were either on the direct oral anticoagulant (DOAC) rivaroxaban (Xarelto, Janssen and Bayer) or the antiplatelet drug ticagrelor (Brilinta, AstraZeneca) at the time of urgent on-pump cardiac surgery.

The paper—authored by Kambiz Hassan (Asklepios Klinik St Georg, Hamburg, Germany) and colleagues— was recently published in the peerreviewed journal, Annals of Thoracic and Cardiovascular Surgery.

The authors completed a retrospective analysis of 171 consecutive patients undergoing urgent surgical repair for acute type A aortic dissection between 2014 and 2020 and identified 21 patients (12.3%) who were either on rivaroxaban (n=9) or ticagrelor (n=12). Among these 21 patients, 10 patients received intraoperative haemoadsorption, and their operative and clinical outcomes were compared with the 11 patients not treated with intraoperative haemoadsorption.

Baseline characteristics were generally comparable between the two groups, however, haemoadsorption patients were older (mean age 75 vs. 62 years) and had higher perioperative risk based on the calculated EUROSCORE II scale (17.1 vs. 10.6; higher score reflects higher risk for complications and mortality).

Although the operative techniques and duration on cardiopulmonary bypass were similar between the two groups, total operation time was significantly shorter in the haemoadsorption group (286±40 minutes vs. 348±79 minutes, p=0.045), presumably due to less time required to achieve haemostasis at the end of the operation.

Most importantly, CytoSorbents highlights in a press release, intraoperative haemoadsorption (vs. without) was associated with favourable clinical outcomes following urgent type A aortic dissection surgery, including: Positive trend in lower 30-day

mortality: 10% (1/10) vs. 27.3% (3/11) Zero need for reoperations (vs.

18.2% without haemoadsorption) Significantly lower mean 24-hour chest tube drainage, an independent predictor of postoperative morbidity and mortality (482±122 ml vs. 907±427 ml, p<0.001) Significantly fewer platelet transfusions (p=0.049) The above clinical benefits translated to shorter median intensive care unit (ICU) length of stay in patients treated with haemoadsorption (four days) compared to those without (nine days).

Efthymios N Deliargyris, chief medical officer of CytoSorbents stated: “This new publication extends the evidence for clinical benefit with intraoperative antithrombotic removal using our haemoadsorption technology beyond coronary artery bypass grafting (CABG) and into additional complex cardiac operations, such as acute type A dissection aortic surgery. All urgent cardiac surgeries are complex and carry high risk for complications, but as any cardiac surgeon will attest, operating in the presence of antithrombotic drugs such as ticagrelor or DOACs can result in significant bleeding complications which can negatively impact patient outcomes and increase costs.”

Deliargyris concluded: “These encouraging data, though from a small single-centre study, are consistent with the published literature on the use of our technology to reduce bleeding complications from cardiothoracic surgery in patients on antithrombotic drugs. Furthermore, it validates our strategy to include patients undergoing urgent aortic surgery in both the STAR-T and STAR-D trials. We plan to incorporate these new data in our recruiting and training efforts with study sites. The US STAR-T and STAR-D trials, evaluating the use of DrugSorbATR for intraoperative removal of antithrombotic drugs during urgent cardiothoracic surgery, are our top priorities. We remain laser-focused and are dedicating all necessary resources to drive enrolment completion of these two studies in the next 12–18 months to support potential future FDA [US Food and Drug Administration] marketing approval.”

enrolling rapidly and has already crossed the 50% enrolment mark in just over 10 months.

The trial—under lead principal investigator (PI) Suai Chieh Tan, head and senior consultant, Department of Renal Medicine, Singapore General Hospital, Singapore, along with site PIs Edward Choke (Sengkang General Hospital, Singapore) and Jackie Ho Pei (National University Heart Centre, Singapore)—targets enrolment of 170 patients with end-stage kidney disease (ESKD) and a matured dysfunctional AVF across these three sites.

The primary aim of the trial is to evaluate primary circuit patency improvement at six months while comparing the MagicTouch AVF and placebo plain balloon in 1:1 randomised fashion.

According to a Concept Medical press release, the trial is doing “exceedingly well”, with 90 patients successfully enrolled so far. And, although the past year was shrouded

by COVID-19, and impacted many healthcare institutions, the rate of enrolment has not slowed down.

“I would like to thank all the patients who have participated in the study. I hope that, together, we can find a better treatment to improve your health and many others who are experiencing the same recurring problem of a dysfunctional fistula,” said Tan. Plain balloon angioplasty has historically been the “go-to” procedure in this area, the release adds. However, its long-term patency is poor, as ESKD patients often experience re-narrowing of their AVF or arteriovenous graft (AVG) due to stenosis. Paclitaxelcoated balloons are also being used to treat dysfunctional AVF—but mixed results have been coupled with safety concerns raised by the US Food and Drug Administration (FDA) regarding paclitaxel, Concept Medical claims.

The sirolimus-coated balloon thus “seems to be a promising option”, the release concludes, as the MagicTouch AVF was granted Breakthrough Device designation by the FDA in 2019, and the IMPRESSION RCT “will provide much-needed data” to reinforce this.

IMPRESSION trial assessing MagicTouch AVF passes 50% enrolment Concept Medical has shared the latest update from its IMPRESSION (Sirolimus-coated balloon angioplasty versus plain balloon angioplasty in the treatment of dialysis access dysfunction) randomised controlled trial (RCT), as it crosses the 50% enrolment mark.

The IMPRESSION trial enrolled its index patient on 11 January 2021 to assess the efficacy of the MagicTouch sirolimus-coated balloon (Concept Medical) against a placebo plain balloon in dysfunctional arteriovenous fistulas (AVFs). Since then, the prospective, multicentre, two-arm parallel group RCT has continued

Veryan Medical’s BioMimics 3D vascular stent system

Three-year results of Veryan Medical’s MIMICS-3D EU study revealed at ISET 2022

Veryan Medical has confirmed the release of MIMICS-3D EU threeyear results by the study principal investigator Michael Lichtenberg (Vascular Center Arnsberg, Klinikum Hochsauerland, Arnsberg, Germany) at this year’s International Symposium on Endovascular Therapy (ISET 2022;

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Market Watch 31

Clinical News 16–19 January, Hollywood, USA).

MIMICS-3D EU is a prospective, multicentre, observational registry to evaluate the BioMimics 3D vascular stent system. The study evaluated safety, effectiveness and device performance within a real-world clinical population of 507 patients enrolled in 23 pan-European sites.

The mean age of enrolled patients was 70 years; 66% were male and 37% were diabetic. Rutherford 0–1, 2–4 and 5–6 were 1%, 82% and 17%, respectively. Mean lesion length was 126mm and 57% of lesions were occlusions. Lesion calcification according to PACSS (Rocha-Singh KJ et al, 2014) was Grade #0—18%; #1—30%; #2—24%; #3—15%; #4—14%. BioMimics 3D placement followed atherectomy in 8% of lesions.

Drug-coated balloons (DCB) were combined with BioMimics 3D in 50% of lesions treated.

Technical success for the BioMimics 3D implant procedure as assessed by the operator was 99%, Veryan Medical reports. An independent clinical events committee adjudicated major adverse events (MAE) including death and potential device-related events. The primary safety endpoint was a composite of MAE, comprising death, major index-limb amputation or clinically-driven target lesion revascularisation (CD-TLR) through 30 days. The primary outcome measure for effectiveness is freedom from CD-TLR through 12 months.

A press release details that the Kaplan Meier (KM) estimate of freedom from CD-TLR at one year, two years and three years in the intention-to-treat (ITT) population was 90%, 82% and 78%, respectively.

The KM estimate of freedom from loss of primary stent patency (PSVR >2.4) through three years in the ITT population was 71%. There were 4/676 (0.6%) site-reported stent fractures Lichtenberg commented: “I have been using BioMimics in my daily clinical practice for seven years and it is my ‘go to’ stent for a number of different indications, including long lesions, calcified lesions and lesions located in the distal SFA [superficial femoral artery] and proximal popliteal.

I was delighted to be the principal investigator for the MIMICS-3D study and am pleased that the results further validate earlier results from the MIMICS clinical programme, the combined database of which provides significant validation of the clinical benefits of swirling flow.”

Nick Yeo, Veryan’s CEO noted: “I would like to thank Dr Lichtenberg for his significant contribution to the successful running of the MIMICS-3D study, providing invaluable leadership and guidance throughout. I would also like to thank all the other investigators

and study coordinators who contributed to the success of the study, and particularly for being so rigorous about the quality of data collected, which is unusual for a typical registry of this type. CD-TLR and patency outcomes in the MIMICS-3D EU study are consistent with those of earlier MIMICS studies and are achieved in longer, more complex lesions. We are excited that these investigations into the postmarket performance of BioMimics 3D support the hypothesis that imparting non-planar curvature onto the femoropopliteal arteries to promote swirling blood flow and increase wall shear stress, results in clinical outcomes that are comparable to those of drug-coated and drugeluting devices.”

Cost-effectiveness of TCAR versus carotid endarterectomy addressed in new study

A cost-effectiveness model based on peer-reviewed sources suggests that although five-year costs for transcarotid artery revascularisation (TCAR; Silk Road Medical) were higher than those for carotid endarterectomy (CEA), TCAR afforded greater quality-adjusted life years (QALY).

The study is published in the December 2021 issue of the Journal of Vascular Surgery.

According to principal author Mahmoud Malas, from the University of California San Diego (San Diego, USA), “TCAR was developed to address the deficiencies associated with both CEA and TFCAS [transfemoral carotid artery stenting]. Several studies have shown that TCAR has one-half the stroke rate of TFCAS. Further, it has similar stroke and death outcomes compared with CEA while reducing the incidence of cranial nerve injury and myocardial infarction.”

“Although the clinical benefits of TCAR have been clearly established, there is little data comparing its costeffectiveness with CEA,” continues Malas. “The purpose of this study was to compare the quality of life, efficacy, and cost-effectiveness among patients undergoing TCAR versus CEA.” As reported in JVS, the San Diego group led by Malas created a model that simulated the outcomes of 10,000 symptomatic patients undergoing either TCAR or CEA. QALY was defined as the product of time and patient quality of life (scale 0–1). Cost-effectiveness was assessed with an incremental costeffectiveness ratio (ICER) calculated as the incremental costs divided by incremental QALYs. Cost-effectiveness was defined as an ICER <US$150,000/ QALY. The team found the five-year costs per procedure to be US$8,821 per 2.85 QALY for CEA and US$19,154 per

2.92 QALY for TCAR. GoBack helps clinicians achieve such The calculated ICER for TCAR was a goal, especially in more complex US$152,229 over five years. Based on lesions.” a nationally accepted standard used With these positive results, Upstream by the authors, TCAR was considered plans to make the GoBack available cost-effective 49% of the time. to hospitals and peripheral vascular “The present study utilises catheterisation labs throughout microsimulation models to compare the world. Rottenberg explains, the cost, efficacy and cost-effectiveness “The GoBack helps facilities of TCAR versus CEA in symptomatic manage their costs and maximise patients, said Malas, in discussing their lab optimisation by reducing the study results. Although procedure time and using the five-year costs for less consumables per TCAR were approximately procedure.”

US$11,000 greater than A press release details those for CEA, it afforded that the GoBack catheter greater QALYs and may be is a single-lumen crossing cost-effective in the long catheter which features term.” a curved nitinol needle New technology in patient that serves as an effective care may be associated crossing tool. The needle with a significant cost when Mahmoud Malas can be extended straight introduced. It is likely the or to a curved position clinical benefits of TCAR will also beyond the GoBack catheter’s tip. The prove to be cost-effective as the use of protrusion length is determined by the the procedure becomes more common clinician with a thumb selector on the and its costs gradually decrease, the device’s handle. The GoBack comes in authors conclude. two configurations of 4 French and 2.9 French for above- and below-the-knee Study confirms efficiency procedures. The GoBack has regulatory of Upstream Peripheral’s approval in 30 countries.

GoBack catheter for complex lower limb revascularisations

Upstream Peripheral Technologies announced today that its GoBack catheter for crossing and reentry was proven very effective for patients undergoing complex revascularisations in lower limb arteries. The findings are based on a peer-reviewed study published in the Journal of Endovascular Therapy.

In a single-centre retrospective study led by Andrej Schmidt (University Hospital Leipzig, Leipzig, Germany), researchers reviewed outcomes of 100 consecutive patients who underwent treatment with the GoBack catheter after failed crossing attempts using standard guidewire and support catheter techniques. All lesions were confirmed as either de novo or reoccluded chronic

Upstream Peripheral’s GoBack catheter

total occlusions (CTOs). The overall technical success rate was 92%.

According to Upstream, the study highlights the versatility and effectiveness of the GoBack catheter as both a crossing and re-entry tool when compared to alternative products, and further outlines the clinical benefits of the GoBack catheter with its robust, retractable needle at its tip.

Dani Rottenberg, founder and CEO of Upstream, remarked, “All patients should have access to the most effective endovascular revascularisation technologies to avoid unnecessary bypass surgeries and amputations. The

First patient enrolled in PEERLESS study of FlowTriever system

Inari Medical has announced that the first patient has been enrolled in PEERLESS—a prospective, randomised controlled trial (RCT) comparing the outcomes of patients with intermediate-high risk pulmonary embolism (PE) treated with the FlowTriever system versus catheterdirected thrombolysis (CDT).

The first PEERLESS patient was enrolled by Amir Kaki, interventional cardiologist, Ascension St John Hospital, Dearborn, USA. PEERLESS will randomise 550 patients and will also enrol up to 150 patients in a registry cohort for patients who cannot be randomised due to an absolute contraindication to thrombolytics. The trial will include up to 60 centres in the USA and Europe.

“We are excited and honoured to enrol the first patient in this landmark clinical trial,” said Kaki. “From our own experience, the FlowTriever system has the potential to change the way we treat PE patients, safely removing significant clot burden while avoiding thrombolytics and procedure-related ICU stay. Ascension St John’s research team continues to be on the cutting-edge of medical device research and we look forward to contributing and developing the evidence base for the treatment of pulmonary embolism.”

“The start of PEERLESS represents an exciting milestone in the advancement of PE treatment, where randomised clinical data evaluating relevant patient outcomes has been limited,” said global co-principal investigator, Carin Gonsalves (Thomas Jefferson University, Philadelphia, USA).

March 2022 | Issue 93

32 Market Watch

Product News Humacyte’s Human Acellular Vessel for limb salvage evaluated in multiple complex vascular reconstruction scenarios

Humacyte today announced results from the first series of compassionate use cases of the company’s investigational Human Acellular Vessel (HAV) for the treatment of chronic limb-threatening ischaemia (CLTI) and vascular trauma.

The HAVs were observed to remain patent and infection free in patients requiring vascular reconstruction, thereby highlighting the potential of the HAV to expand limb salvage options for patients who have exhausted current revascularisation conduit options, a company press release communicates.

These results were presented at the 46th Annual Winter Meeting of the Vascular and Endovascular Surgery Society (VESS; 27–30 January, Snowmass, USA).

Humacyte details that their HAVs are engineered replacement vessels being designed to be durable, infectionresistant and off-the-shelf to address long-standing limitations in vessel tissue repair and replacement. The company reports that, under the US Food and Drug Administration’s (FDA) expanded access programme (EAP), the HAV has been implanted in more than 20 patients to address multiple severe vascular repair, reconstruction and replacement conditions when there is not a suitable conduit available for treatment.

The results of eight of these EAP patients were reported at the VESS meeting by Alexander Kersey (Uniformed Services University of the Health Sciences and Walter Reed National Military Medical Center, Bethesda, USA), in a presentation, titled, “Real-world experience with the Human Acellular Vessel: A bioengineered implant for arterial repair that expands limb salvage options.”

Each of the patients had severe peripheral arterial disease (PAD) or vascular injury requiring vascular reconstruction but lacked other treatment options and were at risk for limb loss. In this high-risk group of patients, five of the bypasses performed with the HAV currently remain patent (with follow-up times ranging from four to 20 months after surgery), and no incidences of infection of the HAV were noted. Researchers treating these patients concluded that the HAV may greatly expand opportunities for limb salvage in trauma and urgent vascular reconstruction when patients lack suitable alternative conduits.

“Many patients who require urgent vascular reconstruction due to vascular injury or severe PAD are not candidates for synthetic vascular

grafts or autologous vein grafts, and those who have exhausted other treatment methods are at high risk of amputation,” said Kersey. “There is considerable need for a new treatment option to avoid resorting to amputation, and results from these compassionate use cases merit additional research into the role the HAV may play in the future of limb-sparing surgery.”

In addition to infection resistance and durable patency, the presentation highlighted the potential clinical utility of the HAV that can be implanted using normal surgical procedures as a readily available, biological alternative for patients at high risk for amputation.

The HAV is currently being evaluated in late-stage clinical trials in vascular trauma repair, arteriovenous access for haemodialysis, and PAD. Humacyte advises that the HAV is an investigational product candidate and is not currently approved for sale by the FDA or any international regulatory authority.

Medtronic recalls HawkOne directional atherectomy system due to risk of tip damage during use According to the US Food and Drug Administration (FDA), Medtronic is recalling its HawkOne directional atherectomy system.

Medtronic’s HawkOne directional atherectomy system

The FDA has identified the recall as a Class I—the most serious type in that “use of these devices may cause serious injuries or death.” So far, there have been 163 complaints, 55 injuries and no deaths reported in relation to the device issue, the FDA reported.

HawkOne consists of a catheter and cutter driver, and is used during procedures intended to remove blockage from peripheral arteries. The recall was made “due to the risk of the guidewire within the [system’s] catheter moving downward or prolapsing when force is applied during use,” according to the FDA. The company distributed an urgent medical device notice to customers on 6 December 2021, requesting they share reports of the defect with all relevant parties, and review both HawkOne’s instructions for use (IFU), and the warnings and precautions listed in the urgent notice letter, before using the product.

“In accordance with our commitment to patient safety, Medtronic recently initiated a voluntary recall to customers

related to the risk associated with tip damage caused by guidewire prolapse in its 6 French (6Fr) HawkOne directional atherectomy system,” Medtronic said in a statement. “In our letter to customers, Medtronic noted that a small number of customer reports of tip damage (at a rate of 0.168% when compared to quantity of devices distributed) during the use of the 6FR HawkOne devices. While most of these instances were resolved without patient issue, a small number required endovascular retrieval (0.033%) or open surgical retrieval (0.028%).”

The statement added that there are no product retrievals or disposals requested associated with the recall and no actions required for patients treated with HawkOne. Should the catheter function as outlined, the FDA reported in a medical device recall advisory, “the catheter tip may break off or separate and this could lead to serious adverse events, including a tear along the inside wall of an artery (arterial dissection), a rupture or breakage of an artery (arterial rupture), decrease in blood flow to a part of the body because of a blocked artery (ischaemia), and/or blood vessel complications that could require surgical repair and additional procedures to capture and remove the detached and/or migrated (embolised) tip.”

Medtronic asked customers to complete a confirmation form enclosed in the urgent notice letter and email them to rs.cfqfca@medtronic.com.

Medtronic issues voluntary recall for TurboHawk Plus directional atherectomy system

On 7 February, Medtronic sent a notice emphasising that the same warnings and precautions issued for HawkOne apply for the TurboHawk Plus 6Fr directional atherectomy system due to design similarities. The company stresses that this is not a new issue.

“There is no product retrieval or disposal requested at this time,” Medtronic communicates in a news alert, which details that approximately 800 devices are impacted by this recall.

“Additionally, there are no actions

Medtronic’s Turbohawk Plus directional atherectomy system

required for patients treated with the TurboHawk Plus 6Fr or any Medtronic directional atherectomy devices,” the alert continues.

Medtronic advises that there have been zero reports of tip damage and zero reports of injury or death on the TurboHawk Plus device.

BD launches new Crosser iQ CTO recanalisation system

BD has announced the launch and US Food and Drug Administration (FDA) 510(k) clearance for the Crosser iQ chronic total occlusion (CTO) recanalisation system, which is designed to cross peripheral artery CTOs intraluminally.

The Crosser iQ ultrasonic CTO device was developed to help improve CTO crossing predictability to aid clinicians treating these challenging lesions. The CTO crossing device also pairs the Crosser iQ ultrasonic CTO device with the BD recanalisation system and the Recon support catheter.

The new system utilises proprietary technology that automatically adjusts the crossing power output to help stabilise the distal tip of the device to assist in crossing through the entire length of the CTO intraluminally.

The BD recanalisation system and Crosser iQ ultrasonic CTO device are indicated to facilitate the intraluminal placement of conventional guidewires beyond peripheral artery CTOs, the company claims. The Crosser iQ ultrasonic CTO device is contraindicated for use in carotid arteries.

The device utilises a unique mechanism of action that is specifically designed to vibrate against peripheral arterial CTOs creating an intraluminal channel to facilitate the placement of conventional guidewires.

During the procedure, power from the BD recanalisation system is converted into ultrasonic vibrational energy causing microbubbles to expand and implode at the tip of the Crosser iQ ultrasonic CTO device. This breaks the internal structure of the plaque and erodes the solid surface of the CTO, allowing the physician to automatically and selectively ablate plaque, while remaining atraumatic to elastic tissue.

Philips integrates cloudbased AI and 3D mapping into its mobile C-arm system series Royal Philips today announced physicians will now have access to advanced new 3D image guidance capabilities through its image-guided therapy mobile C-arm system— Zenition. The system will deliver enhanced clinical accuracy and efficiency, according to Philips, and aims to improve outcomes for patients undergoing endovascular treatment.

The company has signed a strategic partnership agreement with Cydar, a UK based provider of cloud-based procedure maps software to plan and guide surgery in real time.

As patient numbers rise and procedures become more complex

Philips’ Zention mobile C arm platform

Issue 93 | March 2022

Market Watch 33

Product News and time-consuming, patient-specific real-time procedure planning and guidance, optimisation of equipment utilisation, and usability have become ever more important. To help overcome these challenges, Philips details that its image-guided therapy mobile C-arm system—Zenition—brings together innovations in image capture and processing, ease-of-use, and versatility, many of which were pioneered on Philips’ image-guided therapy platform Azurion. Like Azurion, the Zenition mobile C-arm system allows hospitals to maximise operating room performance, enhance their clinical capabilities, and provide staff with a seamless user experience, the company claims.

The integration of Cydar EV Maps software into the Zenition platform now adds extended procedure planning and real-time 3D guidance capabilities.

Philips states that Cydar EV Maps assists in the planning, realtime guidance, and postprocedure review of the endovascular surgery.

It brings cloud-based artificial intelligence (AI) and computer vision to mobile surgery, enabling reductions in radiation exposure, fluoroscopy time, and procedure time together with improved ease of use. It

enables surgeons to create a detailed, patient-specific 3D map of the target vasculature to help plan surgery, the company adds, and then uses these maps to augment intraoperative live image guidance, updating the maps in real time to account for deformations during surgery, such as guidewires and instruments deforming the patient’s blood vessels.

Philips notes that Cydar EV also facilitates post procedure outcome analysis. The combined result of this integration of procedure planning, guidance and review is that surgeons can work more accurately and efficiently—enabling an approximate 50% reduction in radiation exposure, a significant reduction in fluoroscopy time and a reduction of procedure times by more than 20%, according to Philips, all while helping achieve better outcomes for patients.

“With Philips’ integrated portfolio, using validated AI and cloud technologies, we can facilitate collaborative care to optimise surgical pathways,” said Karim Boussebaa, general manager Image Guided Therapy Systems at Philips. “Philips has a strong global network of mobile surgery systems and recognises that Cydar’s EV Maps solution can play

a key role in further improving our integrated offering for endovascular procedures.”

“By partnering with Philips to bring our Cydar EV Map solution to Philips’ user-friendly Zenition platform of mobile C-arms, we are a step closer to achieving our mission to ensure every image-guided minimally-invasive surgical procedure goes exactly as planned,” said Paul Mussenden, CEO of Cydar. “The benefits of this combined solution, with integrated and enhanced procedure planning and visualisation, include shorter and more predictable procedure times, reduced X-ray exposure to patients and staff, and fewer injections of iodine dye—the leading cause of in-hospital kidney failure.”

Cydar EV Maps is currently in use across the EU, UK and USA. It is certified Software-as-a-Medical Device with EU CE mark and US Food and Drug Administration (FDA) 510(k) clearances.

Transit Scientific announces successful use of XO Cross platform in challenging peripheral vasculature Transit Scientific recently announced that its XO Cross platform has been successfully used in challenging peripheral vascular procedures.

A press release details that Jihad Mustapha, interventional cardiologist at Advanced Cardiac & Vascular Center in Grand Rapids, USA, has

performed several procedures using 2F XO Cross 14 microcatheters in 90cm and 175cm lengths, designed to facilitate guidewire support, guidewire exchange, and contrast media injection during complex peripheral vascular interventions.

“The 1:1 torque of the XO Cross 14 provided new levels of trackability during the procedures,” Mustapha states. “The XO Cross 14 performed well when treating anterior tibial artery (AT) to posterior tibial artery (TA)

Transit Scientific’s XO Cross platform

pedal loop chronic total occlusions (CTOs), showing uniquely impressive navigation throughout the pedals, saving time and elevating treatment capabilities.”

He adds: “The XO Cross 14 enabled me to effectively cross four chronic CTOs in the pedal loop and then push up into the proximal posterior tibial to treat an additional CTO during a limbsalvage procedure. I would not have been able to access this CTO without the XO Cross 14 catheter.”

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March 2022 | Issue 93

34 Market Watch

Industry News CryoLife announces corporate rebranding and changes name to Artivion

CryoLife announced that it was renaming and rebranding itself to Artivion, effective immediately.

Derived from the words “aorta”, “innovation”, and “vision”, the company’s new name and brand reflect its evolution to focus on providing innovative technologies to surgeons who treat patients with aortic disease, a press release details.

In conjunction with these changes, effective 24 January 2022, the company will also change its ticker symbol on the New York Stock Exchange to “AORT” from “CRY.” “Through a combination of legacy products and strategic acquisitions and divestitures over the last five years, we have transformed from a tissue and adhesives focused company to one with a premier portfolio of aortic products,” said Pat Mackin, chairman, president and chief executive officer of Artivion.

“Today marks an important milestone for our company. We look forward to embarking on our next chapter as a leader in developing

simple, elegant solutions to address cardiac and vascular surgeons’ most difficult clinical challenges in treating patients with aortic disease.”

Artivion will discuss its business, its strategy, and the rebrand at an Investor & Analyst Day on 23 March 2022, in New York City, the press release advises. Details of the event will be provided at a later date.

Dialysis tech firm Pathfinder Medical secures £8.5 million

Pathfinder Medical, which has developed a proprietary technology to guide and accurately align catheters in endovascular procedures allowing clinicians to make connections across blood vessels in the body without the need for open surgery, has announced securing £8.5 million.

The funding is led by investors BGF and Parkwalk, joined by a number of industry insiders, and with support from existing investor Deepbridge Capital, a press release from the company says.

Pathfinder was co-founded in 2014

by Robert Dickinson and CEO Sorin Popa, following the latter’s research at

Calendar of events

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

9–11 May Advanced Health Education (Ahed) Advanced Endovascular Intervention Course - 3rd Edition Lisbon, Portugal

12–14 June 25th European Vascular Course (EVC) Maastricht, The Netherlands

www.ahed.pt/en/

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

The first Selution SLR study was initiated in July 2020 and involved 134 patients. Enrolment was completed in September 2021. Its objective is to assess the safety and efficacy of Selution SLR in the treatment of lesions of superficial femoral arteries and/or popliteal arteries. The acquisition will facilitate expansion of the Japanese clinical trial programme, which will include diseases of the inferior femoral artery, arteriovenous (AV) fistula access used for kidney dialysis and a drug-eluting balloon for the treatment of erectile dysfunction.

“We are very excited to have acquired MDK Medical, as we now have direct access to the Japanese market”, said MedAlliance chairman and CEO Jeffrey B Jump. “We will be focusing on gaining approval for Selution SLR in Japan, one of the world’s most important markets”.

MedAlliance acquires Japanese partner MDK Medical

MedAlliance has acquired its partner MDK Medical. MDK Medical has previously worked closely with MedAlliance in developing Japanese clinical studies for its novel sirolimus drug-eluting balloon (DEB) Selution SLR in the treatment of peripheral arterial disease (PAD).

MedAlliance’s Selution SLR DEB

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.

26–28 April Charing Cross (CX) Symposium 2022 London, UK, in person & virtual www.cxsymposium.com/cx2022/

Imperial College London into the use of electric fields for guidance in medical device procedures. The key application of the technology is in the dialysis field, where a robust connection needs to be made between an artery and a vein to enable the filtering of the blood.

Traditionally, this was done through an open surgical arteriovenous fistula (AVF) creation procedure, whereas Pathfinder’s device enables a minimally invasive, endovascular approach (endoAVF), the release notes.

The multimillion-pound investment has been raised to support additional preclinical work, complete a pivotal trial in patients, and ultimately secure regulatory approval prior to commercialisation in key medical markets across the world. To date, the business has received over £6 million of funding from investors including Deepbridge, a consortium of angels and specialist grant funders.

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

www.vascular-course.com/

15–18 June Society for Vascular Surgery (SVS) Vascular Annual Meeting Boston, USA www.vascular.org/vam

10–14 September Cardiovascular and Interventional Radiological Society of Europe (CIRSE) Barcelona, Spain cirse.org/events/cirse-2022

20–23 September 36th European Society for Vascular Surgery (ESVS) Annual Meeting Rome, Italy esvs.org/events/annual-meeting

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

8–10 November Paris Vascular Insights (PVI) Paris, France parisvascularinsights.com/

15–19 November VEITHsymposium New York, USA

www.veithsymposium.org/index.php

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