Vascular News 92 – November 2021

November 2021 | Issue 92

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CX Aortic Vienna: Highlights

Joseph Bavaria Type A dissection enters a new revolution

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Next generation of vascular surgeons need open and endovascular skills Building and maintaining expertise in both open and endovascular surgical techniques will play an important role in training the next generation of surgeons in order to optimise outcomes in patients with vascular disease. This is among the key messages to have emerged on the final day of CX Aortic Vienna 2021 (5–7 October, broadcast), when speakers discussed training in aortic procedures, and at other meetings this Autumn. In addition, the need for multidisciplinary working was advocated, and the place of centralised, specialised centres for vascular conditions scrutinised.

E

choing polling results and discussion from day one of CX Aortic Vienna in which there was agreement over the importance of offering a choice between open and endovascular approaches for aortic conditions, speakers including Society of Thoracic Surgeons (STS) past president Joseph Bavaria (University of Pennsylvania, Philadelphia, USA), stressed the need to have multiple options open to patients with aortic disease.

Bavaria’s presentation zeroed-in on the importance of having a multidisciplinary thoracic aortic team, including collaboration across the boundaries of both vascular and cardiovascular surgery. The goal of this type of collaboration is to move towards an aortic centre, Bavaria said, describing this as the multidisciplinary “holy grail”.

During discussion, he remarked: “The way this is going to end up, certainly in the large centres, is that we are going to be going to the aortic centre concept. That concept is a way of bringing everyone together to wrap around the aorta in a 360-degree fashion with a multidisciplinary approach, with people with different skillsets.”

Also speaking during the session, Eric Roselli (Cleveland Clinic, Cleveland, USA) presented a view on the future of training for surgeons who will specialise in the aorta. He commented that aortic disease “knows no boundaries” and offered the opinion that there is a need to “think smarter about how we offer care for this complex disease”.

Both open and endovascular approaches can be complementary, he added, and said that the focus has to be on what the patients’ needs are, based around the details of aortic disease and the interplay of comorbidities.

Roselli added that aortic care requires a mixed skillset, combining both cognitive and technical attributes, and said that overlapping training programmes involving specialists from cardiology, vascular surgery, and cardiothoracic

Profile: Michael Jenkins

surgery are important components in the future landscape for aortic surgery training.

Following the two opening presentations, the audience was asked to vote upon whether there is a desire to see multidisciplinary aortic teams.

There was total support in favour of the multidisciplinary philosophy, with a 100% vote for the motion.

Later in the session Maani Hakimi (Luzerner Kantonsspital Luzern, Switzerland) offered a view on treatment of abdominal aortic aneurysm (AAA) from the perspective of a training centre for vascular and endovascular surgery. One of Hakimi’s key themes was the development of training over time, commenting that teaching has shifted from a mentoring-based system, more towards a centralised curriculum.

“There was total support in favour of the multidisciplinary philosophy, with a 100% vote for the motion”

“Bypass is not disappearing”

At Paris Vascular Insights, Peter Schneider (University of California San Francisco, San Francisco, USA) also spoke on training, and specifically the need to remain skilled in femorotibial/pedal bypass, echoing the discussion at CX Aortic Vienna on the need for trainees to learn both open and endovascular skills.

Schneider recalled that an “extremely important question” when he was a trainee was ‘how will we learn endovascular?’. A couple of decades later, “the shoe is completely on the other foot,” he said, noting that the question now is ‘how will the trainees learn femorotibial bypass or pedal bypass and/or how will we maintain those skills?’

“Bypass is not disappearing,” the presenter declared, referring to a graph showing a downward trend but then a stabilisation, at least of cases in the USA. Instead, bypass is evolving, Schneider stated. “We are going to more distal

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Head-to-head trial shows superiority of FemoSeal over ProGlide for peripheral interventions Results of the randomised, prospective, multicentre STEP trial show that the FemoSeal vascular closure system (Terumo) is superior to the Perclose ProGlide suturemediated closure system (Abbott) in peripheral arterial disease (PAD) patients in terms of technical success using a retrograde femoral puncture.

Bahaa Nasr (Brest University Hospital, Best, France) presented the late-breaking data at Paris Vascular Insights (PVI) 2021 (21–23 October, Paris, France), concluding that FemoSeal should be used in PAD patients undergoing lower limb arterial endovascular treatment, especially if they are discharged on the same day as their surgery.

ACCORDING TO NASR, MANY studies have compared vascular closure devices (VCDs) for the coronary arteries, while none have compared them for PAD. “We all know that the efficacy of a VCD is different for PAD patients because of the plaque nature in the common femoral artery,” he remarked.

In order to assess this gap in the literature, Nasr and colleagues initiated the STEP trial.

“The aim of the study was to perform a direct, head-to-head comparison between ProGlide and FemoSeal,” he relayed, explaining that the FemoSeal is a double polymer resorbable disc, while the ProGlide involves a direct suture in the artery. He noted that the primary endpoint was VCD technical success, assessed five hours post-procedure, and defined as either haemostasis without the need for either an additional VCD or manual compression, or a drop in haemoglobin.

Patients were included in the study if they had received endovascular treatment for PAD with the use of 5–7Fr sheath, Nasr informed the PVI audience. He added that patients who had undergone previous ipsilateral open repair of the common femoral artery, previous stenting at the puncture site, or had either Continued on page 6

Continued on page 4

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November 2021 | Issue 92

Top story

Next generation of vascular surgeons need open and endovascular skills Continued from page 1

targets, we are going after endovascular failure, and we are treating patients with worse disease morphology and worse tissue damage in the foot.”

In addition to this evolution, Schneider noted that “we know a few things about how to get good results from bypass,” giving the example of better wound healing when there is a bypass targeting a specific angiosome.

Peter Schneider at PVI

“A lot of these things that are coming to a head will be answered by the BEST trial, which is now fully enrolled,” he detailed, also noting that the BASIL-2 trial is currently enrolling in the UK. Anticipating the data that might come out of these trials, Schneider predicts that there will be subsets of patients who are “probably better served with a bypass”.

The PREVENT III trials is “probably the best level 1 evidence that we have”, according to Schneider. This was a randomised trial that included over 1,400 patients with bypasses to the lower leg and foot, showing “quite good” primary and secondary patency, as well as limb salvage.

Turning to the key question of how to remain skilled in bypass surgery, Schneider believes that this should be addressed from a programmatic standpoint that “really depends on the size of your programme and the number of bypasses being done”. He elaborated: “If you get fewer than a couple of bypasses a month, you really have to think about involving more people, having a robust preoperative discussion on the planning so that the trainees and the younger doctors who may not be as familiar with these operations have a chance to understand the thinking, the

thought process that goes into success to assess and analyse your complications, and a limb salvage team and conference really helps.”

The speaker told the PVI audience that, in the USA there is an interest in courses, mini-fellowships and proctorships for training. “I think in the early days of endovascular we learned that those things can be effective and now, in attempting to maintain our bypass skills, they are also likely to be effective,” Schneider believes.

In concluding, Schneider considered more generally the role of the vascular surgeon. “One of the things that defines us is our ability to provide both endovascular and open surgery, and we are not going to be very good as a member a multidisciplinary team if we look just like every other member, and I think it is best if we maintain these skills.”

“I just want to curb the enthusiasm,” said Eric Ducasse (Bordeaux University Hospital, Bordeaux, France), opening the discussion following Schneider’s presentation. “By doing endovascular first, for the large majority of patients, we are saving time and treating more and more patients,” he noted.

“Even if you are a very, very strong endovascular-first enthusiast, which I pretty much am, on most patients, there is going to be a group who will fail endovascular, maybe once, maybe twice, maybe every six months for some period of time, and those patients really should be considered if they are still a candidate for bypass, and that is why we need to maintain those skills.”

Moderator Lorenzo Patrone (West London Vascular and Interventional Centre, London, UK) wanted to know Schneider’s opinion on whether chronic limb-threatening ischaemia (CLTI) treatment should be centralised, in line with the trend in aortic care. Schneider expressed caution: “I will say that for every one complex aorta there are a dozen or more patients with critical limb and […] the idea now that you are going to try and limit access even further and funnel those patients to specific centres, it may create more barriers rather than fewer.”

Let us push each other to be the best we possibly can be at all of these procedures” Peter Schneider Patrone was also keen to find out his opinion on whether trainees should aim to be either best at endovascular or best at open surgery. “I do not think it is the stripes we wear,” Schneider replied. “I think it is your energy, your enthusiasm, your persistence to learn everything you possibly can. Let us push each other to be the best we possibly can be at all of these procedures and save as many legs as we can.”

News in brief

The latest stories from the vascular world

n SURGICAL TRAINING: One of the biggest challenges for education in the wake of COVID-19, writes Celia Riga (London, UK), is integrating service and training priorities whilst managing a “significant” care backlog. In order for this to work, Riga advocates that providers “must stay reactive to training need, identify new ways of practice and consequently new ways of learning”.

For more on this story go to page 6. n RADIATION: In a session titled “Reduction of radiation challenges” at CX Aortic Vienna 2021 (5–7 October, broadcast), experts highlighted new technologies with the potential to make aortic surgical procedures simpler and shorter, thereby reducing radiation exposure to patients and care teams. Tilo Kölbel (Hamburg, Germany) demonstrated the use of Fiber Optic RealShape (FORS; Philips) laser light guidance in an edited case, while a satellite symposium saw early users of FORS speak about their key experiences with this developing technology.

For more on this story go to page 13.

n RENAL DENERVATION: Following the release of the European Society of Hypertension’s (ESH’s) updated position paper on renal denervation, Konstantinos Tsioufis (Athens, Greece), immediate past president of ESH, discusses the use of renal denervation in the treatment of hypertension, considers the latest evidence in favour of the approach, and outlines the questions still to be answered.

For more on this story go to page 28.

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November 2021 | Issue 92

New Data

Head-to-head trial shows superiority of FemoSeal over ProGlide for peripheral interventions Continued from page 1

radial, brachial or antegrade femoral punctures were excluded.

Nasr relayed that all patients were treated with a duplex scan-guided, retrograde common femoral artery puncture. He detailed that the resumption of ambulation was assessed five hours after the procedure and that all the investigators were certified and trained for both VCDs. A total of 230 patients were randomised, with 109 patients undergoing treatment with the assigned device in each group. According to Nasr, the baseline clinical and demographic characteristics were well balanced between the two groups. The presenter highlighted the fact that most of the patients included in the study had intermittent claudication—86% in the FemoSeal group and 85% in the ProGlide group.

The majority of the procedures were performed under local anaesthesia and the most commonly-used sheath was 6Fr diameter, Nasr told PVI delegates. He added that there were no differences in intraoperative antithrombotic regimens, and in fact the only difference between the two groups was the need for

a compression dressing, which was higher in the ProGlide group.

Nasr reported that the intention-to-treat analysis showed an 80% technical success rate in the FemoSeal group, which was higher than the 50% rate achieved in the ProGlide group. The difference in technical success could be explained by the need for additional VCDs and a greater need for manual compression in the ProGlide group, the speaker explained. He elaborated: “In the ProGlide group, when taking into account the use of a second VCD, the technical success rate was 90%.” Postoperative bed rest and hospital stays were similar in both groups, the presenter communicated.

The rate of minor access-related complications were higher in the ProGlide group, he added, noting finally that the additional cost per patient valued between 23 and 30% in favour of FemoSeal.

Moderator Marianne Brodmann (Medical University of Graz, Graz, Austria) was “really impressed” that

The intention-to-treat analysis showed an 80% technical success rate in the FemoSeal group, which was higher than the 50% rate achieved in the ProGlide group”

Providers must stay reactive to training need in postpandemic recovery phase Celia Riga Comment & Analysis One of the biggest challenges for education in the wake of COVID-19, writes Celia Riga, is integrating service and training priorities whilst managing a “significant” care backlog. In order for this to work, Riga advocates that providers “must stay reactive to training need, identify new ways of practice and, consequently, new ways of learning”.

THE PANDEMIC HAS HAD A profound and direct impact on craft specialties. Health Education England (HEE) has worked closely with national, regional and local partners to define the scale of COVID-19 disruption to postgraduate training and mitigate the impact. According to Joint Committee on Surgical Training (JCST) data, the number of elective training cases “lost” in the UK since the start of the pandemic, has reached over one million.

Surgical logbook analysis has shown a 50% reduction in operative numbers across all surgical disciplines, despite resumption of elective surgery activity.

A risk assessment evaluation earlier in the year identified that 8% of trainees on active surgical placements are at

high risk of non-progression and a further 5% at an intermediate risk. Of those, 30% are at critical progression point—towards either completion of core surgical training or completion of higher surgical training—reaching 50% for some surgical specialties. Cardiothoracic and vascular surgery are two specialties, particularly at risk both nationally and across the London region. There are significant financial implications to training extensions for those unlikely to meet their Certificate of Completion of Training (CCT) targets. Based on Annual Review of Competency Progression (ARCP) outcomes between May and July 2021, a 12-month delay to Certification for 87 trainees in general surgery alone, would cost over £5 million over two

Bahaa Nasr at PVI

Nasr and colleagues had found the device to be more cost effective, adding a more general comment that it is a “very good idea” to compare two different VCDs for peripheral interventions. In this vein, Brodmann was keen to know if the speaker thought more studies should be conducted and more devices compared in order to end up with one device. “I think we have to talk about other devices,” Nasr replied, noting also that investigators must compare devices with magnet compression and low-profile sheaths.

Speaking from the audience, Eric Ducasse (Bordeaux University Hospital, Bordeaux, France) stressed that data concerning other factors—such as the distance between the artery and the skin and previous fibrotic intervention—is required in order to “really compare objectively” the different systems.

years to cover locum consultant contracts.

The impact of the pandemic on training progression has also resulted in national recruitment restrictions to single figures, with some London specialties unable to recruit at all in the first round.

One of the biggest challenges for education as we enter the post-pandemic recovery phase, is integrating service and training priorities whilst managing the significant UK National Health Service (NHS) care backlog. Clinicians have a professional obligation to train at all times, and this role must be recognised and formalised by local and regional providers. To enable trainees to gain essential competencies lost during the pandemic individual training prescriptions have been introduced to support bespoke training plans and wellbeing. HEE will facilitate trainee movement between employers through trainee passports, overcoming traditional administrative barriers. Along with the General Medical

There is a much anticipated “longCOVID training” effect that will heavily influence education, workforce planning and service delivery in the next five years”

Council (GMC) curriculum derogations, training academies, high-volume, lowcomplexity initiatives and fellowship programmes are being explored. HEE is also supporting the development of digital solutions to improve access to clinics, multidisciplinary teams (MDTs) and additional teaching sessions. With additional government funding, HEE has provided £12.09 million to trusts in England to enable recovery interventions.

A further £10m is being distributed through regional postgraduate deans to support Specialty Schools within their geographical areas. The London School of Surgery, the UK’s largest postgraduate surgical training institution, has secured a significant investment towards the delivery of Surgical Skills training through cadaveric, ex-vivo, synthetic and digital simulation models across five key London sites. A further investment to support the development of an HEEapproved online Surgical Library with technology-enhanced learning capabilities is planned. As the major assessment period progresses, training extension rates are currently significantly lower than original projections. However, there is a much anticipated “long-COVID training effect” that will heavily influence education, workforce planning and service delivery in the next five years. For effective education and healthcare reform, therefore, providers must stay reactive to training need, identify new ways of practice and, consequently, new ways of learning.

Celia Riga is a consultant vascular surgeon at Imperial College London (London, UK) and the Head of London School of Surgery, HEE.

Issue 92 | November 2021

Conference Coverage

Study detects higher incidence of chromosome aberrations in endovascular operators Researchers have observed an increased frequency of chromosomal aberrations in endovascular operators that is likely to be related to occupational radiation. Speaking in the Prize Session at this year’s European Society for Vascular Surgery (ESVS) annual meeting (28–29 September, Rotterdam, The Netherlands and online), presenter Mohamed Abdelhalim—a doctoral research fellow supervised by Bijan Modarai at King’s College London (London, UK)—conveyed his hope that, with more research, biodosimetry will be used as an adjunct to physical dosimetry in the future.

M

odarai and colleagues have previously shown a rise in acute markers of DNA damage in endovascular operators. According to the research team, however, there has been no analysis of biological markers of chronic DNA change to date.

The present research focused in part on dicentric chromosomes, the presenter relayed, noting that these are the “gold standard” for biodosimetry.

Such chromosomes are a rare occurrence in the lymphocytes in the normal population, whereas their frequency rises proportionately with radiation exposure, he explained, making them a “very good marker” for radiation damage. Dicentric chromosomes are also associated with malignancy, Abdelhalim added.

The team’s research also considered

translocations, which, the presenter clarified, are exchanges of genetic material between two or more chromosomes, some of which are transmissible and therefore have a malignant potential. The final area of research was aneuploidy, which is when a chromosome is lost entirely from a cell, Abdelhalim noted, causing genomic instability and thus having the potential for malignant transformation.

The researchers hypothesised that chronic occupational radiation exposure from endovascular procedures increases the frequency of chromosome aberrations and so aimed to determine the incidence of chromosome aberrations in highvolume endovascular operations.

Abdelhalim summarised the team’s research, which they conducted in

Study provides new tool to assess amputation risk following popliteal vascular injury A large, multicentre cohort study provides a simple, practical method to effectively stratify patients preoperatively into lowand high-risk major amputation categories.

ACCORDING TO LEAD AUTHOR Leigh Ann O’Banion (University of California, San Francisco, San Francisco, USA), “traumatic popliteal artery injuries present a serious clinical challenge because they are associated with the greatest risk of limb loss of all peripheral vascular injuries, with major amputation rates of 14–25%.”

Previous scoring systems, such as the Mangled Extremity Severity Score (MESS), attempt to determine a threshold beyond which repair is futile.

O’Banion states: “The aim of the present study, unlike the older systems, was to provide an easy to use scoring system that could be used to preoperatively and effectively risk stratify patients with traumatic popliteal vascular injuries for major amputation.”

As reported in the September 2021 issue of the Journal of Vascular Surgery, O’Banion and colleagues from 11 medical centres from the Western Vascular Society retrospectively examined the outcomes of patients who had undergone operative

collaboration with experts in radiation biology both from Public Health England and Brunel University in London, UK. The team isolated lymphocytes from peripheral blood samples, stimulated mitosis in these lymphocytes, arrested mitosis exactly at the point of metaphase, and then fixed the samples to microscope slides, before separating the samples into two groups: a dicentric assay and a sample analysed with mFISH. “Both of these techniques are incredibly time consuming and labour intensive,” the presenter remarked. Despite this, he conveyed that the team were able to analyse 54,000 cells with the dicentric assay and 2,000 cells with mFISH, which he described as a “completely manual process”.

The team recruited a total of 18 operators for the study, 12 of whom were exposed endovascular operators, with the remaining six being radiation-naïve

We have shown what is left behind after years of performing [endovascular] procedures, and that is something that has never been done before”

repair for traumatic popliteal arterial injuries from 2007–2018 and identified the factors independently associated with limb loss.

They compared the clinical data between those who ultimately required major (above ankle) amputation with those who did not, and subsequently validated the new scoring system in a random 20% of this population.

Characteristics of the study population (n=355) included: Mean age of 33±14 years, Male, 80%,= Blunt injury, 66%, and; Associated orthopaedic injury, 80% (41% dislocation).

At a mean follow-up of 69 days, the overall amputation rate was 16%, but those who lost primary patency had a major amputation rate of 46%. These findings

Traumatic popliteal artery injuries are associated with major amputation rates of

14 ­25% Leg arteries; image converted using ifftoany

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colorectal surgeons, used as controls.

Abdelhalim noted that there were no significant differences between potential confounders between the groups, such as age, years of consultant practice or smoking status. All of the operators in the exposed group did high volumes of endovascular procedures, the speaker added.

“The frequency of dicentric chromosomes is significantly higher in endovascular operators compared with colorectal surgeons,” Abdelhalim revealed. Other key findings were that reciprocal translocation was more common in endovascular operators compared to controls, complex chromosomal arrangements were twice as common, and there was a significantly higher frequency of aneuploidy in the endovascular cohort.

“Something that has never been done before”

Panellist Jonathan Boyle (Cambridge University Hospitals NHS Trust, Cambridge, UK) wanted to know what was new in the presentation compared to the studies already published by the research group. “Previously, we looked at acute markers, in that, immediately after an EVAR [endovascular aneurysm repair], you have a rise in these markers, and then they normalise completely. So, whether you do one EVAR or 100, it is the same,” Abdelhalim explained. “Here, we have shown what is left behind after years of performing these procedures, and that is something that has never been done before.”

underscore the critical need for close follow-up.

Significant preoperative risk factors for amputation included: Systolic blood pressure <90mmHg (odds ratio [OR] 3.2), Orthopaedic injury (OR 4.9), and; Lack of pedal Doppler signals (OR 5.5).

Using this information, a Popliteal Scoring Assessment for Vascular Extremity Injuries in Trauma (POPSAVEIT) score was created, assigning one point for blood pressure and two points for both the orthopaedic injury and no Doppler signals.

The study validated the scoring system revealing amputation rates were: 25.5% for a score of 3–5 points vs.

5.9% for a score of 0–2 points (p<0.001).

O’Banion explains: “When evaluating the patient comprehensively, the POPSAVEIT score divides the findings into three critical components: measures of global physiologic insult (blood pressure), musculoskeletal deformity (orthopaedic injury), and ischaemia (Doppler examination).

“This preoperative assessment tool could be used to effectively communicate and risk stratify patients across centres similar to the American Association for the Surgery of Trauma’s injury scoring scales, which are widely accepted and used across trauma centres.

Additionally, the ability to risk stratify could be useful in discussing the prognosis and setting expectations with patients, their families, and other providers.”

This study confirms that patients with popliteal vascular injuries are at significant risk for amputation.

According to the authors, the POPSAVEIT tool may be valuable in assessing this risk as soon as the patient enters the emergency room.

Issue 92 | November 2021

Conference Coverage

Type A dissection enters a new revolution “We are at the beginning of a type A dissection revolution,” Joseph Bavaria (University of Pennsylvania, Philadelphia, USA) told attendees at London Aorta 2021 (16–17 September, London, UK). In a keynote lecture, Bavaria charted the history of type A dissection management—from the Crawford era to the present day—and outlined what is to come. He stressed that global collaboration, good data and honest reporting of outcomes will be key to harnessing new technologies and techniques in the upcoming decade and beyond.

O

pening his lecture, Bavaria referenced a Japanese study that highlighted the importance of bettering type A dissection management.

He précised that everybody who died in the emergency room in one state in Japan got a computed tomography (CT) scan autopsy, which revealed that 8.1% of all deaths resulted from type A dissection, leading Bavaria to remark that the condition “is probably a lot more prevalent than we think”.

The Crawford era: “Nothing was certain”

In the 1990s, type A dissection management was in the [Stanley] Crawford era, Bavaria detailed. “When I looked at the Stanford data, as well as our own data from [the University of Pennsylvania], we reported a 25% mortality rate and a 25% stroke rate for type A dissection,” he said.

The presenter explained that the Crawford era of type A dissection management was defined by clamping the ascending aorta and only entering the arch if there was a visible tear that extended to the clamp. This technique “really was a disaster, but it was the best for that time,” Bavaria summarised. “Nothing was certain, it was intraoperative chaos and the bottom line was a lot of death and destruction,” he added, noting that there was no understanding of resuspension or proper indication for root surgery in type A dissection.

In addition to the high mortality rate associated with the procedure, Bavaria also noted a 4% mortality rate between admission to the hospital and admission to the operating room. “The result was a 30% mortality and stroke rate across the world at this time—the 30/30 club.”

The classic phase: Optimisation of circulation management

In the mid- to late-1990s, the cardioaortic surgical community designed a “therapeutic operation” for type A dissection, Bavaria told the London Aorta audience, which was intended to address the issues causing death in the first two weeks.

The speaker explained what was involved in the classic operation at the arch: “We did a hemiarch and then we placed neomedia to obliterate the distal false lumen, which caught the dissection

just perfectly. We used advanced circulatory adjuncts instead of just straight circulatory arrest alone.”

Optimisation at this time revolved around understanding the key concept regarding circulation management of the open aortic arch, Bavaria relayed.

He elaborated: “The morbidity and mortality of short arch reconstructive times, less than 30 minutes or so, is an embolic phenomenon. The morbidity and mortality of a longer arch reconstructive time, say greater than 35 minutes, is a global neurological deficit and this is what applies to a type A dissection. This actually changed our practices at that time, when we started using an antegrade cerebral perfusion for the majority of dissections.”

New millennium sees focus on the aortic root

The next phase of type A dissection management history, which saw a shift in focus towards the aortic root, can be dated to the mid- to late-2000s, Bavaria told the audience.

“The type A dissection arch consensus at the time was that an open distal aortic arch procedure was basically standard of care. The single-clamped anastomosis was simply not appropriate,” he explained. “But what about the root?” he asked, rhetorically, answering that aortic valve insufficiency in these cases, for the most part, is related to the dissection at the aortic root. “Resuspension and aggressive reconstruction of the valve can be done in many, many cases”.

Ascending aortic cannulation “safe and effective” Bavaria then turned to the future of type A dissection management, which, he believes, will revolve around four areas: central aortic cannulation, the root, a distal aortic solution and an endoaortic solution.

Regarding cannulation, the speaker made it clear that “there is no perfect place to cannulate in a type A dissection”. He communicated that his group at the University of Pennsylvania has adopted the central aortic cannulation first strategy, with 95+% of their patients receiving a central cannulation. Bavaria also referenced a study by Thomas G Gleason et al at the University of Pittsburgh (Pittsburgh, USA),

which found that, in 264 consecutive cases, central aortic cannulation reduced incision to bypass time by half.

“The bottom line of this is that ascending aortic cannulation is safe and effective and is no worse than axillary or femoral cannulation and has a lot of benefits, especially with regard to opening up the true lumen right away,” Bavaria commented.

Reoperation at the root should be minimised

“We must design operations at the root so that the reoperation at the aortic root is minimised,” Bavaria urged, highlighting that native valve retention during type A dissection is safe, works well and is “definitely part of [the University of Pennsylvania’s] future approach,” noting a 91% freedom from reoperation of the root at 10 years with a “robust” neomedia/resuspension technique. “The goal [at the root] is to retain our native valves when possible.

We can address the root aggressively, we do root procedures in the appropriate cases, otherwise repair of the root and valve and get good results”.

Distal aortic solutions “the most important part”

“Acute DeBakey type I dissection is a total aortic catastrophe,” Bavaria stated, adding that “we must address this issue if we are going to improve outcomes.”

Thoracic endovascular aortic repair (TEVAR)-enabling solutions will be the answer, the presenter believes, who sees

We need good data, we need better outcomes, and we have to be honest with our reporting” the future of aortic arch treatment as a competition between two different concepts: the frozen elephant trunk (FET) and the zone 2 arch with sequential branch TEVAR completion.

He sees a number of advantages to the latter: “It is a simpler distal anastomosis, it can address most complex arch tears and eliminate the flap in the proximal head vessels. It is a much shorter operation, a much easier operation, […] it allows all definitive TEVAR options, there is less risk of recurrent nerve injuries, and it is not doing an unnecessary distal procedure at an

Joseph Bavaria

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index operation when it is not necessary.”

In short, the revolution in this area will be the creation and design of an index operation based on the availability of new technology, according to Bavaria. “The future based on our data and our increased sophistication with the available technology, is that we really have a tripartite algorithm,” Bavaria relayed, noting that this is now the approach at the University of Pennsylvania. “In patients with a less than 10 or 15-year life expectancy, say greater than 65 or 70 who have a type A dissection, every one of those patients gets a classic hemiarch, for the most part. In patients with a primary arch tear or a distal malperfusion, which is about 20–25% of the patients, they will get a frozen elephant trunk.

But everybody else, which is a lot of patients, and in patients less than 65 who are relatively stable in the sense they do not have a malperfusion, they get a zone 2 arch with a sequential branched graft TEVAR, for which we anticipate approval in the USA soon.”

Towards an endo solution

“Type A dissection and its treatment is the holy grail,” Bavaria said, noting, however, that it is a “hostile” territory for TEVAR. “We have new devices and new trials going on right now,” he relayed, referencing in particular the ARISE early feasibility investigational device exemption (IDE) trial looking at a Gore ascending endograft. In addition, Bavaria predicted that, in the future, “we are all going to be doing all type A dissections in a hybrid operating room”.

Aside from technological advancements, Bavaria also noted that an audit function is key as the cardioaortic community is “going to be doing lots of new stuff in the proximal aorta, across the globe”. This will require honesty, he stressed, suggesting that institutionalised databases, preferably at the level of the professional societies, are needed.

Key factors: Good data, better outcomes, honest reporting

Bavaria forecasts that the next decade will be mostly about distal aortic solutions. “Index proximal operations will be driven and conceived by the availability of new technology endografts, zone 0, 1, and 2 TEVAR branched arch grafts, proximalisation of the conduct of operation will continue to reduce nerve injury and solutions that are collateral network friendly to decrease spinal cord ischaemia. All of these must enable TEVAR completion,” he remarked.

While it is “too early to have guidelines on type A dissection repair and aortic arch surgery,” Bavaria said, due to the “dynamic” nature of the condition, he ended by stressing what are the key factors necessary to making the most of the upcoming revolutionary era in type A dissection: “We need good data, we need better outcomes, and we have to be honest with our reporting.”

Issue 92 | November 2021

Journal Highlights 11

Study shows decreased mortality for patients with complex aortic aneurysms treated with fenestrated or branched endografts

430

430 patients were included in the study, with an average age of 74

6%

A recent study revealed that endovascular repair of complex aortic aneurysms using fenestrated and branched endografts provides a safe and effective alternative to open surgical repair, with the lowest ever reported mortality rate in this patient population. This is according to researchers at The University of Texas Health Science Center at Houston (UTHealth Houston, Houston, USA) and Memorial Hermann Heart and Vascular Institute Aortic Center (Houston, USA).

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he study, “Midterm outcomes of a prospective, nonrandomised study to evaluate endovascular repair of complex aortic aneurysms using fenestrated-branched endografts,” led by senior author Gustavo S Oderich (McGovern Medical School at UTHealth Houston), was published in the September 2021 Annals of Surgery.

The study focused on treatment of complex aortic aneurysms, including pararenal and thoracoabdominal aortic aneurysms, which affect the aorta and the branches to the kidneys and intestines.

These aneurysms are associated with high risk of rupture and death. While most aortic aneurysms are not associated with symptoms, if undiagnosed, progressive enlargement can lead to rupture with a high fatality rate.

The researchers reported that endovascular repair using fenestrated and branched endografts was associated with a 1% risk of mortality at 30 days, which compares to a mortality of 21% in a recent study of over 14,000 patients treated by open surgical repair in the USA. The improvement in mortality also

Spinal cord injury affected 6% of patients enrolled

1%

Endovascular repair using fenestrated and branched endografts was associated with a 1% risk of mortality at 30 days

Modern abdominal aortic aneurysm metrics support expanding current screening guidelines

Results of a database review of more than 500,000 abdominal aortic aneurysm (AAA) repairs revealed the majority of patients treated for rupture did not meet the criteria for aneurysm screening. These findings were reported in the August 2021 issue of the Journal of Vascular Surgery.

ACCORDING TO FIRST AUTHOR KIRSTEN D Dansey (Beth Israel Deaconess Medical Center, Boston, USA), “Although the screening policy has likely contributed to the decrease in the incidence of ruptured AAAs, the proportion of ruptured AAAs occurring in patients currently excluded from screening is unknown. Our aim in this study was to identify the proportion of patients who had presented for AAA repair, but were not eligible for screening.”

Using the National Inpatient Sample from 2004–2015, researchers from Beth Israel Deaconess Medical Center identified ruptured and intact AAA admissions and repairs using the International Classification of Diseases codes. They evaluated 65,125 admissions for ruptured AAAs and 461,191 repairs for intact AAAs. Current US Preventative Task Force screening criteria for AAA includes males between the ages 65 and 75 with a history of smoking. Those who did not meet the criteria for screening included: 68% of all patients admitted for AAAs 59% of patients who had undergone repair for ruptured AAAs Of those who did not qualify for screening: 63% were aged >75 years 24% were aged <65 years 36% were women

Abdominal aortic aneurysm

Expansion of the screening criteria to include selected women and a wider age range should be considered”

compares favourably to mortality rates of open repair in large aortic centres, which range between 9–17%.

“When we began the study, we had no idea the rate of mortality would be so much lower than the historical results of open surgical repair,” Oderich said.

The study, which included 430 patients with an average age of 74, also showed better outcomes regarding major adverse events, including paralysis and paraplegia caused by spinal cord injury. Spinal cord injury affected 6% of patients enrolled in the fenestrated or branched endovascular aneurysm repair (F/BEVAR) study, which is similar to contemporary open surgical studies in which the rate of spinal cord injuries reported was 5–10%.

This research is supported by Cook Medical and GE Healthcare, which provided funding for research coordinator support.

When we began the study, we had no idea the rate of mortality would be so much lower than the historical results of open surgical repair”

Over the study period, endovascular aneurysm repair (EVAR) increased for: rupture from 10% to 55% with a mortality of 35% intact AAAs from 45% to 83% with a mortality of 2% “The current screening guidelines are not based on modern practice data,” Dansey said. “The advantage of using EVAR is missed when calculating which patients would benefit from this low-risk procedure. Patients aged >75 years constituted more than one half of the patients admitted with AAA rupture and represent a critical and increasing screening-ineligible population.

This population will realise an especially high benefit of undergoing repair on intact AAAs, given the difference in mortality of 45% after repair of rupture AAAs versus 1.3% after repair of intact AAAs.” The authors noted that the UK’s National Institute for Health and Care Excellence (NICE) guidelines for AAA diagnosis and management found benefit for AAA screening for a prevalence as low as 0.35%.

According to Dansey, “It would be reasonable to conclude that screening women, who have a prevalence of AAA of 1.7% (reported for women with a positive smoking history) would be cost-effective, as was recommended in the NICE guidelines.”

Dansey further stated, “The number of ruptured AAA admissions has decreased over time, suggesting that screening and implementation of EVAR have had a positive effect. However, the number of repairs for rupture AAAs has remained unchanged, suggesting that screening remains underutilised.”

Researchers concluded most patients who had undergone repair for ruptured AAAs did not qualify for screening and EVAR was the primary treatment of both ruptured and intact AAAs with relatively low in-hospital mortality. Based on their findings, the team suggested that expansion of the screening criteria to include selected women and a wider age range should be considered.

November 2021 | Issue 92

12 Conference Coverage

CX AORTIC VIENNA

Open surgery remains a wellaccepted option to treat challenging aortic arch Results of a poll conducted at CX Aortic Vienna 2021 (5–7 October, broadcast) indicated that open procedures have their place in treating the hostile anatomy of the aortic arch, with 100% of voters expressing the opinion that the open elephant trunk technique should still be taught. This followed a series of presentations and edited cases on the frozen elephant trunk (FET) technique.

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ichael Jacobs (Maastricht University Medical Center, Maastricht, The Netherlands) opened the session with an edited case demonstrating the open surgical extension of a frozen elephant trunk (FET) in the aortic arch and thoracoabdominal aneurysm. He concluded that FET makes proximal anastomosis easier in open repair and also that the thoracoabdominal aortic aneurysm (TAAA) procedure is similar to the standard operation without a FET. Jacobs also summarised the findings of his team’s research: “We faced perioperative mortality, however the long-term outcomes are very favourable”.

A multidisciplinary approach is key to improving results and planning patient-tailored solutions. This was the main conclusion of Luca Bertoglio (VitaSalute San Raffaele University, Milan, Italy), who presented perioperative and midterm outcomes of open or endovascular treatment of downstream thoracic or thoracoabdominal aortic pathology after FET. He

summarised that FET is an optimal solution when any kind of distal thoracic procedures are planned, and that different distal open and endovascular solutions are available.

Michael Borger (University of Leipzig, Leipzig, Germany) argued that the elephant trunk technique remains a vital procedure today, highlighting the benefits of open cardiac surgery in the complex anatomy of the aortic arch. “Aortic arch surgery has a long history in cardiac surgery,” he communicated, noting that results are “very good” and have been improving in recent years. In addition, Borger outlined data showing some of the limitations of endovascular therapy. “Although we have made great strides in approaches to the thoracic aorta, there are of course still complications,” he informed the audience.

Borger also detailed that the ascending aorta and aortic arch is “hostile territory” for endovascular therapy due to the angulation and also the extreme

Patients should get a choice between open and endovascular surgery for aortic conditions, CX audience agrees A decisive vote at CX Aortic Vienna 2021 (5–7 October, broadcast) revealed that 90% of the audience was in favour of offering patients a choice between open and endovascular surgery for aortic arch procedures. Edited cases from Thomas Gandet (Arnaud de Villeneuve Hospital, Montpellier, France) and Tilo Kölbel (German Aortic Centre Hamburg, Hamburg, Germany) were among presentations that helped to inform this audience poll. The importance of providing both open and endovascular approaches was also raised in a discussion on aortic coarctation and in a session on dissection.

GANDET’S PRESENTATION outlined the Endo-Bentall procedure—a new endovascular treatment used in ascending aortic pathologies that was later described by moderator Afshin Assadian (Hospital Ottakring, Vienna, Austria) as the “final frontier” in this space. Gandet, a cardiac surgeon, was keen to stress the importance of collaboration between cardiac and vascular surgeons in optimising this complex procedure.

Following this, Kölbel described an aortic arch repair with a three-branched stent graft, concluding that the procedure is feasible and that the use of a steerable sheath reduces cervical access trauma.

He noted that, while there is not much published on the topic, short- and midterm outcomes from his own group, and those from Stéphan Haulon (Aortic

Clockwise from top left: Roger Greenhalgh (London, UK); Roberto Chiesa (Milan, Italy); Afshin Assadian (Vienna, Austria); Tilo Kölbel (Hamburg, Germany); and Thomas Gandet (Montpellier, France).

Centre Marie Lannelongue, Groupe Hospitalier Paris Saint Joseph, Paris, France) and colleagues, have been “very positive” to date.

Clockwise from top left: Roger Greenhalgh (London, UK); Roberto Chiesa (Milan, Italy); Afshin Assadian (Vienna, Austria); Michael Borger (Leipzig, Germany); Luca Bertoglio (Milan, Italy); and Michael Jacobs (Maastricht, The Netherlands).

mobility of this portion of the aorta. In fact, he noted that “it is much more mobile than any other portion of the aorta”.

“I hope that I have convinced you that conventional elephant trunk surgery is still required today,” Borger said, ending his presentation.

In a later presentation, Heinz Jakob (University Hospital Essen, Essen, Germany) described an optimised coagulation regimen in contemporary FET surgery, concluding that it is mandatory to have a modern approach to patient blood management in order to reduce the important risk factor of bleeding and, therefore, improve acute and long-term survival.

In addition to an earlier session debating the role the open elephant trunk technique can play in aortic arch challenges, which saw 100% of CX Aortic Vienna attendees vote in favour of this approach continuing to be taught, these edited cases formed the basis on which the audience decided that patients should be offered a choice between open and endovascular options. Further insight on this topic later came from W Anthony Lee (Florida Atlantic University, Boca Raton, USA), who presented an edited case detailing total endovascular repair of the aortic arch using the Relay triplebranch device (Terumo Aortic), and Kazuo Shimamura (Osaka University Graduate School of Medicine, Osaka, Japan), who discussed the possibility of reducing the risks of stroke and type 1 endoleak via the endovascular ‘chimney technique’ (Gore).

A similar message regarding endovascular and open surgery options came from a separate session later in the day—one that was primarily focused on aortic coarctation. Konstantinos Spanos (Larissa University Hospital, Larissa, Greece and UKE Hamburg, Hamburg, Germany) communicated that endovascular repair of coarctation in adults is effective and has an acceptable safety profile, with balloon-expandable covered stents being the preferred device for most procedures, while stent grafts may be used in co-existence of poststenotic aneurysm. However, responding to a question from moderator Haulon on the role that remains for open surgery, Spanos also noted that much of the current literature states that it is still

preferred in complex heart anatomies like heart hyperplasia or extensive aortic arch aneurysm in coarctation patients.

Discussion also turned to the importance of offering both open and endovascular solutions in a session on aortic dissection. Chair Roger Greenhalgh (Imperial College, London, UK) asked moderator Martin Grabenwöger (Clinic Floridsdorf, Vienna, Austria), a cardiac surgeon, his opinion on whether offering every patient the opportunity of both treatment options should become the norm in the future. “Yes,” he replied, detailing that, in his practice, Grabenwöger takes into account various factors when assessing a patient, including age. While he will choose open surgery for certain patients, he noted that for patients with a lot of comorbidities, he opts for partnering with his endovascular colleagues in the hybrid room.

A decisive vote revealed that 90% of the audience was in favour of offering patients a choice between open and endovascular surgery for aortic arch procedures”

Issue 92 | November 2021

Conference Coverage 13

New technologies will simplify and shorten aortic surgical procedures while reducing radiation In a session on “Reduction of radiation challenges” at CX Aortic Vienna 2021 (5–7 October, broadcast), experts highlighted new technologies with the potential to make aortic surgical procedures simpler and shorter, thereby reducing radiation exposure to patients and care teams. Tilo Kölbel (German Aortic Centre Hamburg, Hamburg, Germany) demonstrated the use of Fiber Optic RealShape (FORS; Philips) laser light guidance in an edited case, while a satellite symposium saw early users of FORS speak about their key experiences with this developing technology.

OPENING THE SESSION, TOM Carrell, executive director of Cydar Medical, outlined the benefits of Cydar EV Maps, which recently received regulatory clearance in the European Union. This software includes integrated planning, navigation and review, offering a dynamic, three-dimensional (3D) map of the current state of a patient’s anatomy, he informed viewers.

Carrell relayed that the technology offers more accurate device positioning and better overall outcomes with a reduced radiation dose, and that each new patient’s plan and surgery is informed by all previous similar cases.

Moderator Andres Schanzer (University of Massachusetts Medical

School, Worcester, USA) congratulated Carrell on an “excellent and provocative talk”, going on to ask about the applicability of Cydar EV Maps. Carrell responded by stressing that Cydar EV Maps is a software and is therefore generally applicable.

Audience polling following Carrell’s talk revealed that 82% of voters in the audience believe intelligent maps for surgery are a useful concept.

FORS provides “new, precise and low-radiation visualisation tool”

In an edited case, Kölbel presented a branched endovascular repair for a type IV thoracoabdominal aortic aneurysm

Physicians and industry alike urged to tackle multifactorial stroke risk following thoracic endovascular procedures As evidence builds on the importance of reducing the risk of stroke by removing residual air prior to thoracic endovascular aortic repair (TEVAR) procedures, the onus will be on surgeons and device manufacturers to minimise this risk—as per a discussion at CX Aortic Vienna 2021 (5–7 October, broadcast). This session also focused on findings from the Stroke from thoracic endovascular procedures (STEP) study, and featured a first-to-podium presentation highlighting the benefits of carbon dioxide compared to standard saline flushing after TEVAR.

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ilo Kölbel (German Aortic Centre Hamburg, Hamburg, Germany) began this session by introducing the problem of cerebral damage following both TEVAR and transcatheter aortic valve implantation (TAVI) procedures— noting that the relatively low rate of postoperative

using FORS laser light guidance.

He concluded that the procedure is feasible, with a low radiation dose and short fluoroscopy time, and that the 3D visualisation FORS offers enhances target vessel catheterisation. Kölbel summarised that FORS provides a “new, precise and low-radiation visualisation tool for complex endovascular aortic repair”.

Moderator Joost van Herwaarden (University Medical Center Utrecht, Utrecht, The Netherlands) was keen to know what the learning curve is for this novel technology, with Kölbel responding that FORS is “very intuitive”. An audience question addressed potential fatigue issues with fibre optic cables, but Kölbel stressed that, in his experience, the cables “usually last the whole case”.

Reflecting on Carrell’s presentation and Kölbel’s case, anchor Roger Greenhalgh (Imperial College, London, UK) remarked: “We have shown the audience the future”.

Early users share key moments with FORS 3D device guidance

In a Philips-sponsored satellite symposium, Kölbel opened a discussion on early users’ key moments using FORS 3D device guidance. Schanzer, Geert Schurink (Maastricht University Medical Center, Maastricht, The Netherlands), van Herwardeen and Marc Schermerhorn (Beth Israel Deaconess

stroke “does not tell the whole story”, as silent brain infarctions (SBIs) are far more prevalent and can lead to a range of neurological disorders later in life. He went on to detail that, while the source of stroke and SBIs is multifactorial, air embolisation caused by devices used in TEVAR and TAVI is one of the key contributors.

Following this, Fiona Rohlffs (German Aortic Centre Hamburg, Hamburg, Germany) outlined the increased removal of residual air that can be achieved by introducing carbon dioxide to the standard, salinebased flushing technique often used in TEVAR, as well as the additional benefit of adding an extra flush port to the stent graft delivery system.

She went on to report preliminary results from the STEP study, which included the first cohort in which carbon dioxideflushed devices had been deployed in endovascular aortic arch repairs, noting an SBI incidence of about 50%— which compares favourably to the 80% rate reported in standard flushing without carbon dioxide.

Session moderator Markus Steinbauer (Barmherzige Brüder Hospital, Regensburg, Germany) stated that the industry is now taking notice of this research into the importance of removing residual air prior to these procedures, with many companies that manufacture TEVAR devices currently attempting to introduce features like additional flush ports. This prompted Roger Greenhalgh (Imperial College, London, UK), the session’s anchor, to claim that research from the STEP registry is paving the way for surgeons themselves to systematically consider how they can minimise stroke risks following thoracic endovascular procedures, before agreeing with Rohlffs that this is a multifactorial problem, and efforts to

Medical Center and Harvard Medical School, Boston, USA) all shared their experiences. Throughout the session, audience members were also encouraged to highlight what they believe to be the key benefits of FORS technology by contributing to a word cloud. The benefit of 3D visualisation was deemed to be the most important element, closely followed by precision and reduced radiation.

Clockwise from top left: Roger Greenhalgh (London, UK); Andres Schanzer (Worcester, USA); Joost van Herwaarden (Utrecht, The Netherlands); Tilo Kölbel (Hamburg, Germany); and Tom Carrell (Barrington, UK).

Also in the “Reduction of radiation challenges” session, Michele Antonello (University of Padua, Padua, Italy) spoke about an off-the-shelf endograft with four inner branches to treat thoracic aortic aneurysm, which, used in conjunction with intravascular ultrasound (IVUS), has resulted in shorter procedural times in his experience.

reduce liquid and solid embolisation are also key.

Evidence on the potential benefit of introducing carbon dioxide into this complex picture was then compounded by Richard Gibbs (Imperial College Healthcare NHS Trust, London, UK), who presented the results of a non-randomised, prospective study comparing carbon dioxide and standard saline flushing in 187 patients. Gibbs reported no difference in clinical stroke outcomes, but did highlight a significant reduction in the total number and surface area of new diffusion-weighted magnetic resonance imaging (DW-MRI) infarcts after carbon dioxide flushing. He concluded that patients are now being randomised across the UK, USA and New Zealand in a larger study designed to further examine this phenomenon.

More insight came from Wolf Eilenberg (German Aortic Centre Hamburg, Hamburg, Germany and Medical University Vienna, Vienna, Austria), who discussed the largest cohort study investigating cerebral microbleeds (CMBs) after TEVAR to date, in which 50% of patients presented with SBIs and 60% had CMBs— warranting further research, not only on the risk factors associated with CMBs, but also their long-term clinical impact. Greenhalgh echoed this view, describing these microbleeds as a “moving target” of which a greater understanding is needed. Referring more broadly to the growing body of evidence on post-TEVAR stroke, Greenhalgh concluded: “Those who are working on this subject are influencing the industry. And, the industry will do all it can, but surgeons will also have to do everything they can—it is a combined effort and, together, we are making progress.”

November 2021 | Issue 92

14 Conference Coverage

CX AORTIC VIENNA

Global experts share knowledge on aortic arch and thoracoabdominal techniques The ever-changing subject of aortic arch and thoracoabdominal treatment was addressed at CX Aortic Vienna 2021 (5–7 October, broadcast), with input from speakers and audience participation from across the globe. Edited cases and presentations from The Netherlands, France, Australia, the USA, the UK, China and Italy outlined the latest developments in the space. The session was also broadcast as part of the China Endovascular Course (CEC).

O

ne such global demonstration came from Michael Jacobs (Maastricht University Medical Center, Maastricht, The Netherlands), who presented an edited case of the ‘clamshell’ incision technique to perform open ascending, arch and descending aortic repair.

Following this presentation, moderator Stéphan Haulon (Aortic Centre Marie Lannelongue, Groupe Hospitalier Paris Saint Joseph, Paris, France) noted that pericardium grafts made from bovine materials—such as the one seen in Jacobs’ presentation—have been a “game-changer” and are now the number one choice in infectious cases. Jacobs agreed, adding that these materials appear to be far more infection-resistant than those previously used.

A later edited case saw George Matalanis (Austin Hospital and Melbourne University, Melbourne, Australia) share a branch-first,

computed tomography (CT) total arch replacement—claiming that the “beauty” of the procedure is that it is adaptable to many different pathologies, both acute and chronic. Matalanis noted that he staged the procedure to improve precision and reduce spinal cord ischaemia (SCI) risks.

An edited case from Gustavo Oderich (The University of Texas Health Science Center at Houston, Houston, USA), who demonstrated a left subclavian artery (LSA) branch reconstruction using an endovascular approach, also featured in this session.

He noted that selective angiography following the procedure confirmed the LSA was widely patent, but also revealed partial coverage of the innominate artery—leading him to realign the scallop using a balloon-expandable stent.

Discussing this, Haulon stated that, if the cone-beam CT had not been performed and revealed this potential complication,

Procedural staging for endovascular repair of extensive TAAA gains CX audience backing A poll conducted at CX Aortic Vienna 2021 (5–7 October, broadcast) saw an overwhelming majority of attendees vote in favour of staging endovascular thoracoabdominal aortic aneurysm (TAAA) repair procedures to reduce the rate of spinal cord ischaemia (SCI), a known complication after endovascular treatment.

This followed a presentation from Luca Bertoglio (Vita-Salute San Raffaele University, Milan, Italy), who demonstrated the benefits of both historical staging and planned procedural staging in reducing permanent SCI with data from 240 patients, and preceded an edited case from Gustavo Oderich (The University of Texas Health Science Center at Houston, Houston, USA), who has played a key role in an emerging shift away from routine cerebrospinal fluid (CSF) drainage in endovascular TAAA repair due to its associated complications.

STÉPHAN HAULON (AORTIC CENTRE Marie Lannelongue, Groupe Hospitalier Paris Saint

the patient may have later had a stroke, further noting that this was “an important message”. Oderich concurred, adding that postprocedural technical assessments are “critical”, while the session’s anchor, Roger Greenhalgh (Imperial College, London, UK), conveyed that the case highlighted a “golden rule” of vascular surgery, which is to always check results on the table.

Elsewhere, Chang Shu (Peking Union Medical College, Beijing, China) presented the HENDO approach to aortic arch repair, which combines hybrid, endovascular and open surgical techniques. Shu shared insight on surgical practice at his centre in China as well, stating that younger vascular surgeons are often trained in open surgery first, before moving on to endovascular techniques later.

Haulon demonstrated a “very challenging” fenestrated endovascular

Edited cases and presentations from The Netherlands, France, Australia, the USA, the UK, China and Italy outlined the latest developments in the space”

Joseph, Paris, France) and co-moderator Michael Borger (University of Leipzig, Leipzig, Germany) agreed that, in practice, they would also prefer to use procedural staging where possible. This preceded the audience poll, which saw 89% of attendees vote that staging procedures makes sense as a means of reducing SCI after elective fenestrated/branched endovascular aneurysm repair (F/BEVAR) procedures.

In a subsequent discussion, Haulon noted that there has recently been a shift away from CSF drainage in endovascular TAAA repair due to the perceived benefits being outweighed by the potential morbidity risks. Bertoglio agreed with this sentiment, but also noted that CSF drainage may be advisable in aortic centres with experienced anaesthesiology teams who can perform drainage at any time, and is still preferred in open surgery too.

Later in this session, Oderich presented an edited case demonstrating BEVAR using a total transfemoral

aneurysm repair (FEVAR) case and also gave a presentation on percutaneous three-branch arch endografting.

Moderator Oderich noted that he has performed just one such case and that the technique is an example of the evolution of the subject over the last 20 years. The area is where industry needs to focus going forward, he commented.

In another edited case, Michele Antonello (University of Padua, Padua, Italy) spoke on the geometrical determinants of target vessel instability in FEVAR, concluding that the sizing and planning of FEVAR should be performed in order to maintain a bridging length <5mm, since a longer distance may be associated with graft misalignment and a higher chance of target vessel instability. He added that new-generation bridging stents have showed a higher flare capability in his experience, and, even if they are not associated with clinical outcomes, show promise.

Moderator Tilo Kölbel (German Aortic Centre Hamburg, Hamburg, Germany) highlighted that Oderich is the “expert” on the topic, having introduced the term alongside Tara Mastracci (St Bartholomew’s Hospital, London, UK), which “really was a change in describing outcomes of branched FEVAR and branched EVAR (BEVAR)”.

Oderich asked Antonello to comment on the rates of renal artery occlusion in his experience. “If we have some very tortuous anatomy of the renal arteries, we switch to renal branches,” he replied, stating his belief that the technology “could be better”.

approach. He reported no technical defects or endoleaks, adding that the patient was free from postoperative complications and was discharged after one week.

Elsewhere, in a first-to-podium presentation of a systematic review and meta-analysis based on existing literature, Dittmar Böckler (University Hospital Heidelberg, Heidelberg, Germany) reported outcomes relating to endograft migration after thoracic endovascular aortic repair (TEVAR) procedures that included 10 studies. He noted a 4% pooled incidence of migration, a 28% rate of migrationrelated reintervention, a 21% rate of migration-related morbidity and a 3% rate of migration-related mortality.

Discussing these findings, he concluded that migration-related reintervention rates appear to be higher than general reintervention rates after TEVAR, but that migration-related mortality rate is lower compared to other post-TEVAR complications. Böckler added that post-TEVAR migration “needs more attention”, with this study underlining the importance of lifelong surveillance following the procedure.

Joseph Coselli (Baylor College of Medicine, Houston, USA) later presented the outcomes of 3,688 open TAAA repair surgeries performed between 1986 and 2021—noting that the 90% rate of freedom from repair failure at 15 years is “excellent” and indicates that open surgery is durable for this indication.

Clockwise from top left: Roger Greenhalgh (London, UK); Stéphan Haulon (Paris, France); Michael Borger (Leipzig, Germany); Joseph Coselli (Houston, USA); Gustavo Oderich (Houston, USA); Luca Bertoglio (Milan, Italy).

Issue 92 | November 2021

The Hurting Leg 17

Improved postoperative glucose control reduces restenosis incidence after infrapopliteal endovascular revascularisation for diabetics

a technical success rate of 87.2%. Primary patency was reported to be 61 (4.2)% and 50 (4.9)%, assisted-primary patency was 69 (5.2)% and 55 (6.1)%, with secondary patency at 71 (3.8)% and 59 (4.1)% at one and two years respectively.

Following Kaplan Meier analysis (estimate [SE]%), AFS was 74 (3.3)% and 63 (3.7)% at one and two years respectively. Cox regression analysis demonstrated that reduced baseline eGFR was highly associated with increased AFS (p=0.014). Furthermore, an independent In patients undergoing infrapopliteal endovascular revascularisation for chronic limbpredictor of AFS (p=0.033) and F-MALE (p=0.023), was threatening ischaemia (CLTI), poor perioperative glycaemic control is associated with a found to be post-procedural dual antiplatelet therapy. higher incidence of restenosis after intervention, with dual antiplatelet therapy associated Within the patient cohort, after infrapopliteal with better outcomes in diabetic patients. These are the main findings of a study recently endovascular revascularisation, a higher incidence of published online in the Journal of Vascular Surgery (JVS). binary restenosis was associated with poor perioperative glycaemic control, the authors report. rixie Yap (Guy’s and St Thomas’ NHS Foundation 70 years, with a ratio of 70:30 male and Cox regression analysis showed Trust, London, UK) and colleagues sought to female patients respectively. Twelve that perioperative capillary blood investigate the impact of perioperative glucose per cent of patients were type glucose level was an independent control and other factors associated with patient one diabetic with 88% of patients predictor for binary restenosis outcomes due to a paucity of evidence in the space. diagnosed type two diabetes. (p=0.015). Additionally, the authors The single-centre, retrospective cohort study enrolled Forty-six per cent of patients were relay that patients with greater 249 patients. Diabetic patients receiving infrapopliteal smokers with an average patient HbA1C post-operatively (58% vs. endovascular revascularisation for CLTI were eligible, estimated glomerular filtration rate (eGFR) 79% at 24 months, >6.5% vs. < 6.5%) however, patients with previous endovascular or surgical of 61±35ml/min/1.73m2. demonstrated significantly worsened interventions in the same leg or hybrid revascularisation Amputation free survival (AFS) and F-MALE. Postoperative glycaemic undertaken concomitant to the infrapopliteal freedom from major adverse limb events control and dual antiplatelet therapy endovascular revascularisation were excluded.

(F-MALE) at one and two years and were found to be modifiable independent Additionally, patients with less than six months of limb salvage were measured per patient predictors of outcome in this cohort, clinical and radiological follow-up or less than 24 hours as endpoints. Binary (>50%) restenosis, following infrapopliteal endovascular of perioperative capillary blood glucose measurements primary, assisted-primary, and secondary revascularisation, with improved were excluded. patency were also measured per target postoperative glucose control possibly The finalised study population included 213 limbs vessel as endpoints. Additionally, through Across 203 patients, improving patency and F-MALE. in 203 patients. Patient records including patient angiography, technical success per target The authors conclude that their findings 437 infrapopliteal demographics, procedural details, capillary blood vessel was identified as immediate patency contribute to current evidence, but stress that target vessels were successfully further studies are required to determine the glucose and haemoglobin A1C (HbA1C) were collected with residual stenosis (<30%) for each of the crossed with a from the institute’s electronic patient records and treated arteries. extent to which intensive glucose control technical success improves outcomes in this cohort following analysed against the study endpoints using Kaplan-Meier Across 203 patients, 437 infrapopliteal rate of 87.2% and Cox regression analysis. The average patient age was target vessels were successfully crossed with infrapopliteal endovascular revascularisation.

T

203

437

87.2%

MolecuLight launches DX device to enable point-of-care imaging of wounds in new expanding market segments MolecuLight has announced the launch of the MolecuLightDX, a new point-of-care device model targeted at the needs of new expanding wound care market segments in the USA. The DX is an expansion of MolecuLight’s product line and compliments the MolecuLight i:X, a press release reads.

SPECIFICALLY, THE MolecuLightDX has the following new features frequently required in these segments: Comprehensive electronic medical record (EMR) integration options for multiple EMR environments

Patient-centric user interface and workflow to allow for easy patient and wound tracking An administrator workflow and system configuration capability Docking system for easier charging of the device As with the i:X, the DX has the same accurate, rapid digital wound measurement for documentation of procedures and of wound progression, MolecuLight claims, adding that a stickerless measurement capability which automatically measures wound area without the need for wound stickers is newly available on the DX. In addition, all MolecuLight procedures will be able to benefit from the reimbursement pathway available in the USA for the MolecuLight procedure, which is applicable to both the MolecuLight i:X and DX devices.

The reimbursement pathway includes two current procedural terminology (CPT) codes for physician work to perform “fluorescence wound imaging for bacterial presence, location, and load” and facility payment for Hospital Outpatient Department (HOPD) and Ambulatory Surgical Center (ASC) settings through an Ambulatory Payment Classification (APC) assignment.

One of the new features of the MolecuLightDX is a larger screen

Primary care professionals must adopt “proactive” approach towards “preventable” non-healing wounds In support of the Legs Matter Campaign’s awareness week (11–15 October), Sam Everington, a GP at the Bromley by Bow Centre in London, UK, and former British Medical Association (BMA) chair, is calling on GPs, pharmacists and other primary care professionals to adopt a proactive approach towards “preventable,” life-threatening or serious leg and foot problems.

EVERINGTON SAID: “THE LEGS Matter Campaign is rightly focused on patient and public empowerment, identifying the small changes that people need to make to create change. Healthcare professionals providing services in primary care and community pharmacies also need to be at the forefront of this change. As GPs and pharmacists, we are there when people seek support for worrying changes or new injuries to legs and feet. We all need to act promptly and provide the right care swiftly so that these wounds do not deteriorate into long-lasting leg or foot ulcers or other serious, chronic conditions. It is simply not necessary and can be prevented.

I would like to see all primary care professionals adopt a proactive approach to the spiralling number of serious leg and foot problems. If more patients and clinicians work together to address this national issue, we can start to turn the

tide on this hidden epidemic.”

As part of the campaign targeting the public and patients; GPs, pharmacists, podiatrists, tissue viability, district and practice nurses are among the healthcare professionals being urged to take action, support the initiative and to sign up for online events during the third national week.

Supported by NHS England, the Legs Matter Campaign was formed by a group of the UK’s leading lower limb clinicians, who, together with patient partners, are campaigning to make serious leg and foot problems a thing of the past.

Operating under the governance of the charity, The Tissue Viability Society, Legs Matter is also made up of representatives from The British Lymphology Society, Accelerate, The Royal College of Podiatry, The Society of Vascular Nurses, The Lindsay Leg Club Foundation, Foot in Diabetes UK and The Leg Ulcer Forum.

November 2021 | Issue 92

18 Interview

PROFILE

Michael Jenkins

“Go for it!” Michael Jenkins urges anyone looking to start a career in medicine, highlighting that the COVID-19 pandemic has put into sharp focus its “vocational and worthwhile nature”. Over the course of his own career to date, Jenkins has seen the shift towards a more minimally-invasive endovascular approach, but stresses that “there is still much work to be done” in this field, predicting a “temporary swing” back in favour of open surgery for some aortic conditions. Currently, Jenkins is president of the Vascular Society of Great Britain and Ireland (VSGBI) and has overseen a “busy year” at its helm. He anticipates the upcoming annual meeting—the first face-to-face VSGBI gathering following a two-year, COVID-19-induced hiatus—will be a highlight of his presidency.

I was good at science at school and it was then natural to aim for medicine. Subconsciously, there may have been an influence from the fact my father died of a sudden myocardial infarction (MI) when I was only four years old. I went in to medicine, always with a view to do surgery. My twin brother was of the same mind and we gravitated towards vascular and cardiac surgery as we both enjoyed the technical challenges. We realised we should choose different paths to avoid confusion though!

He is now a cardiac surgeon at the Royal Papworth Hospital in Cambridge, UK.

Who have been your career mentors?

I think I have always learned something from everyone I have worked for, but was always particularly impressed by good operators as I saw how their patients did better postoperatively. My early experience at the beginnings of endovascular aneurysm repair (EVAR) using homemade devices with Mo Adiseshia was memorable as was my time at the Royal Brompton Hospital (London, UK) with Magdi Yacoub and Chris Lincoln.

Visits to Hazim Safi in Houston, USA, were always inspirational as well.

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

Clearly the shift towards a more minimally-invasive endovascular approach has been a game changer. This has introduced both new techniques and technology and is a big advantage for some patients. It is disappointing that the initial promise has not translated to a durable solution for all though. There is still much work to be done as our patients are surviving longer and deserve longer lasting treatments.

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

I think there will be a temporary swing back in favour to open surgery for some aortic conditions, but I am confident stent grafts will evolve to overcome some of the current deficiencies. Vascular disease is also changing as we move from the smoking era. With an ageing population and more cross-sectional imaging, we will see more aortic dissection patients, but also, the diabetic and obesity epidemics will lead to more distal occlusive disease as well. It is also interesting to watch the landscape of deep venous disease to see if more active treatment of acute and chronic venous thrombosis will improve longer-term outcomes.

What are the biggest challenges currently facing vascular surgery?

I think globally this depends on the local healthcare

sector. Typically, most arterial patients are elderly and undergo expensive treatments. It can be difficult to make the fiscal case sometimes as traditional costeffectiveness calculations are not helpful, so having to be the patient advocate all the time can be challenging.

Workforce demands are also an increasing challenge, certainly in the UK. Newly-appointed consultants are probably better trained than ever before, but less experienced and need mentoring. At the other end of the scale, senior surgeons are not incentivised to stay (the inverse is probably true) and this needs to be addressed urgently to avoid a workforce crisis.

What are your current areas of research?

I am involved in a number of registries and trials of new endovascular devices. My main interest at the moment however is looking at how the aortic neck responds over time and the impact of this on the seal zone, both after standard EVAR and fenestrated EVAR (FEVAR) more proximally. It is interesting how we

I think there will be a temporary swing back in favour to open surgery for some aortic conditions, but I am confident stent grafts will evolve to overcome some of the current deficiencies” compare endovascular and open repair as treatments for aneurysms, but sometimes forget the completely different way in which this is achieved. I am also now convinced that aortic diameter at the seal zone is much more important than we previously believed and that staying within the confines of the instructions for use (IFU) is crucial to improve durability.

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

I think it would be fair to say that my interest has been dominated recently by global COVID-19 developments rather than anything specifically vascular. New data regarding the emergence of new variants and the science behind vaccine development has been fascinating.

Has COVID-19 provoked new ways of working for the vascular surgeon long term?

It certainly provoked new ways of working during the lockdown episodes. Having to make decisions under such circumstances was refreshing in that it bypassed

Andy Watt/NB Illustration

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

some of the red tape which can sometimes delay introduction of new ways of working. Emergency treatment actually became easier as it was not competing with elective activity. Hot clinics and direct entry of patients into accelerated pathways have been very successful and I am hopeful some of these changes will endure, but dealing with the backlog of cases (in some specialties) cannot be underestimated.

What have been the highlights of your VSGBI presidency?

It has been a busy year as it has included the second wave of the COVID-19 pandemic, crafting the response to it and then dealing with how to prioritise cases on waiting lists. It has also coincided with the release of the new vascular curriculum, the three-year cycle of a rewrite of the Provisional of Vascular Services (POVS) document and our new UK vascular journal, the first issue of which will hopefully coincide with our annual

Issue 92 | November 2021

Interview 19

scientific meeting in December. We are aiming for a jam-packed full on face-to-face meeting in Manchester, UK, in December (after a two year COVID-19 gap) so that will certainly be the highlight.

Could you tell us about one of your most memorable cases?

I invest a lot of energy in to all my complex cases so it is then a pleasure to see them again when they return to clinic. I suppose the ones that stick in the mind the most are the really unusual ones. About five years ago, I had to deal with a six-year-old boy with a mid-thoracic stenosis who had been stented in Poland with restenosis down to a pinhole. He had poor renal perfusion, raging hypertension and crippling claudication. I did a bypass and left the graft long enough in a loop in the chest to allow him to grow. A recent scan (now a pretty tall 11-year-old) has confirmed it has worked well. An upcoming case looks as if it will be a memorable one as well—a nine-year-old boy (unclear diagnosis) with a 9cm abdominal aortic aneurysm (AAA) and bilateral 7cm renal artery aneurysms.

What has been your proudest moment of your career to date?

Undoubtedly, being elected as president of the VSGBI by my peers. It is humbling and an honour.

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

Go for it! Although hard work, it is worth it. Both my sons are currently in medical school and loving it.

Medicine has to be one of the most interesting careers available—the vocational and worthwhile nature of a career in medicine has been highlighted by recent pandemic experiences. It also allows such varied options from academia, pure science, community-based work in addition to the more well-known spheres of general practice and hospital work.

What are your hobbies and interests outside of medicine?

I enjoy the mountains and wild places. I did a lot of climbing previously in Wales, Scotland, the Pyrenees and the Alps. Trashing my hands every weekend was not the best preparation for surgery though so I do much less, but still enjoy getting to the wilder areas of the country and love skiing. I have recently taken up cycling (mainly to complete the Hebridean challenge for the Circulation Foundation—visit www. justgiving.com/fundraising/circulationfoundationouterhebrideschallenge if you would like to donate!) and really love it. I also enjoy motorsport, both watching and participating in track driving events and have always enjoyed the design, technical aspects and aesthetics of fast, beautiful cars.

Fact file Appointments (selected)

2002–present: Consultant vascular surgeon, Imperial College Healthcare NHS Trust and Chelsea & Westminster NHS Foundation Trust, London, UK 2020–2021: President, Vascular Society of Great Britain and Ireland (VSGBI) 2016–2019: Chair, Circulation Foundation 2016–2018: President, British Society of Endovascular Therapy (BSET)

2013–2016: Director, Major Trauma Centre, Imperial, NW London Sector, London, UK

1989: Qualified MBBS, University College and Middlesex Hospital School of Medicine, London, UK

Surgical training

Honours and awards (selected)

1997–2002: Higher surgical training, NW Thames rotation, London, UK 1995–1997: Research at University College London (UCL), MS from London University, London, UK 1991–1994: Basic surgical training, Charing Cross surgical rotation, London, UK 1990: A&E and Anatomy demonstrating, UCL

2001: Association of Surgeons of Great Britain and Ireland (ASGBI) Gold Medal winner, FRCS (Gen Surg) 1989: 1st Broderip Scholarship (Pathology, Medicine, Surgery, Clinical Pharmacology & Therapeutics, Obstetrics and Gynaecology)

Issue 92 | November 2021

New Data 21

VIVA

IN.PACT Admiral

IN.PACT Admiral reduces clinically-driven revascularisation in complex target lesions Real-world data drawn from the IN.PACT Global study looking at five-year freedom from clinically-driven target lesion revascularisation (TLR) among prespecified chronic total occlusion (CTO), long lesion and de novo in-stent restenosis (ISR) cohorts “continues to confirm long-term clinical safety and effectiveness” of the IN.PACT Admiral (Medtronic) drug-coated balloon (DCB) in the treatment of complex femoropopliteal lesions.

R

esults from the study—involving 417 patients—were delivered by Gunnar Tepe, head of the Department of Diagnostic and Interventional Radiology at RoMed, Rosenheim, Germany, during a late-breaking session at Vascular Interventional Advances (VIVA) 2021 (5–7 October, Las Vegas, USA).

Key data

Tepe reported that mean lesion lengths were 22.8±9.7cm, 26.4±8.6cm, and 17.1±10.5cm in the CTO, long lesion, and de novo ISR cohorts, respectively. The majority of lesions were calcified, he said.

Kaplan-Meier estimates of freedom from clinically-driven TLR through five years were 69.8% for CTO, 67.3% for the long lesion group and 58% for ISR. The cumulative incidences Gunnar Tepe

These data support incorporating the use of the IN.PACT Admiral DCB into clinical treatment algorithms for complex femoropopliteal disease” of the composite safety endpoint were 69.8%, 65.7%, and 56% in the CTO, long lesion and ISR cohorts, respectively, Tepe continued.

The number of major target limb amputations were very low in all three cohorts, with no amputations in the CTO, two in the long lesion, and one in the de novo ISR cohorts, he told VIVA attendees. KaplanMeier estimates of five-year freedom from all-cause

Two-year Ranger data demonstrate “sustained, high rate” of device efficacy

Patients treated with the Ranger drug-coated balloon (DCB; Boston Scientific) sustained “improved primary patency” with fewer reinterventions than those treated with uncoated devices, two-year results from the RANGER II SFA randomised controlled trial have demonstrated, investigators revealed during a late-breaking session at VIVA. PRINCIPAL INVESTIGATOR RAVISH Sachar, an interventional cardiologist at North Carolina Heart and Vascular at UNC REX Healthcare in Raleigh-Durham, USA, delivered the data, telling attendees that subgroup analyses—covering women, patients with baseline chronic total occlusions (CTOs) and calcified lesions—also suggest “consistent benefit” of DCB treatment versus standard percutaneous transluminal angioplasty (PTA).

Additionally, the two-year results showed no difference in mortality rate between the groups.

In a press release, Boston Scientific said the data confirmed the safety and efficacy of the Ranger DCB compared to standard PTA for the treatment of patients with peripheral arterial disease (PAD) in the superficial femoral artery (SFA) and proximal popliteal artery. The findings follow the May 2021 publication of one-year RANGER II SFA results in JACC: Cardiovascular Interventions.

Sachar and colleagues found that the Ranger DCB exhibited a higher primary patency rate of 84% compared to 71.4% in patients treated with standard PTA (p=0.0129).

The subgroup analyses also showed consistent benefit with greater long-term patency in patients with more complex lesions treated with the Ranger DCB, exhibiting an 89.1% vs. 72.4% primary patency rate in the moderate to severe calcium subgroup (p=0.0052) and a 76.6% compared to a 58.6% primary patency rate in patients with CTOs (p=0.1038).

“These two-year data demonstrate a sustained, high rate of efficacy—including in patients with more complex lesion subtypes, yet another proof point for physicians to consider when determining the best individualised treatment option for their patients with PAD,” said Sachar.

All the new data presented at Vascular Interventional Advances (VIVA) 2021, held 5–7 October in Las Vegas, USA.

mortality rates with vital status were 78.2% (CTO), 75.2% (long lesion), and 81.4% (ISR).

“This is the first presentation of prospectively collected five-year data from prespecified in-stent restenosis, long lesion and chronic total occlusion cohorts from a large global DCB study,” said Tepe.

He concluded: “High five-year freedom from clinically-driven TLR was demonstrated in all three prespecified cohorts, but it was slightly lower in the de novo ISR cohort, highlighting the challenging nature of ISR lesions. No safety issues were reported in any of the cohorts. Freedom from all-cause mortality with vital status at five years was 81.4% for de novo ISR, 75.2% for long lesions and 78.2% for CTOs. These data support incorporating the use of the IN.PACT Admiral DCB into clinical treatment algorithms for complex femoropopliteal disease.”

81.4%

Freedom from all-cause mortality with vital status at five years was for de novo ISR

75.2%

...for long lesions

78.2% ... for CTOs

Study details

The IN.PACT Global study was a prospective, multicentre, singlearm study conducted at 64 international sites that enrolled 1,535 participants, including some with complex lesions.

Assessments through five years included freedom from clinically-driven TLR, safety composite and major adverse events.

One-year results show “superior” primary patency rate for Eluvia compared to bare metal stents

One-year results presented in a late-breaking session at VIVA from the EMINENT trial demonstrated the superiority of the Eluvia drug-eluting stent (DES) system (Boston Scientific) compared to self-expanding bare metal stents for the treatment of patients with peripheral arterial disease (PAD) with superficial femoral artery (SFA) or popliteal artery lesions up to 210mm in length, the principal investigator (PI) said. The study enrolled 775 patients, making it the largest randomised trial of a drug-eluting stent for the treatment of PAD to date, Boston Scientific said in a press release.

IN THE TRIAL, THE ELUVIA STENT EXHIBITED superiority with a primary patency rate of 85.4% vs. 76.3% with bare metal stents (p=0.0087), data presented by EMINENT study PI Yann Gouëffic (Paris Saint-Joseph Hospital, Paris, France) showed. The analysis also showed a significantly greater rate of sustained clinical improvement without reintervention—83% for patients treated with the Eluvia stent compared to 76.6% for those treated with a bare metal stent (p=0.0450).

Further, there was no significant difference in major adverse events or all-cause mortality rates between patients treated with Eluvia and those treated with a bare metal stent through one year.

November 2021 | Issue 92

22 New Data

VIVA

PRESTIGE BTK study shows sustained results of Selution SLR out to 18 months Eighteen-month results from the PRESTIGE below-the-knee (BTK) study were presented as a late-breaking clinical trial at Vascular Interventional Advances (VIVA) 2021 (5–7 October, Las Vegas, USA). The objective of this clinical investigation is to evaluate safety and performance outcomes of Selution SLR (MedAlliance), a novel sirolimus-eluting balloon for the treatment of long tibial occlusive lesions (TASC C and D) in patients with chronic limbthreatening ischaemia (CLTI).

F

reedom from target lesion revascularisation (TLR) was exhibited by 88% of patients and 79% demonstrated amputationfree survival (AFS). The rate of wound healing was 79% and 79% of the patients improved their Rutherford score by at least one category. The 18-month results have been sustained from the sixmonth and 12-month data.

PRESTIGE (Physician-initiated, prospective, non-randomised, singlecentre trial investigating the safety

and efficacy of the treatment with the Selution sirolimus-coated balloon in TASC C and D tibial occlusive disease in patients with critical limb ischaemia from Singapore) is run at the Singapore General Hospital (SGH)

by Chong Tze Tec and Tang Tjun Yip. Twenty-five patients were enrolled with an average age of 64. Eighty-eight had diabetes mellitus and 44% had endstage renal failure. No patients required bailout stenting. Clinical follow-up was at one, three, six, 12 and 18 months.

Real-world data highlight “continued disparities” in CLTI management Medicare claims data “emphasise the importance of vascular care before amputation and the continued disparities that exist in contemporary vascular practice,” Eric A Secemsky (Beth Israel Deaconess Medical Center, Boston, USA) told delegates at VIVA, presenting findings from a real-world evaluation of inequalities in chronic limb-threatening ischaemia (CLTI) management associated with major limb amputation.

SECEMSKY AND COLLEAGUES AIMED TO DETERMINE whether patient, hospital and geographic factors are associated with different intensities of vascular care received prior to major amputation and also the intensity of vascular care received in the year before major amputation is associated with differences in outcomes postamputation.

The team used Medicare claims data from 2016–2019 to identify patients with a CLTI diagnosis who underwent a major lower limb amputation, a VIVA Foundation press release reports. In order to understand the factors associated with the intensity of vascular care received in the year prior to amputation, the researchers categorised intensity was as low (no angiography or revascularisation), medium (angiography only) or high (revascularisation by any method: surgical, endovascular or hybrid). The team then examined the association of patient (demographics, comorbidities), hospital and geographic characteristics with receiving low- (reference group) versus medium- versus high-intensity vascular care before amputation using ordered multivariable logistic regression.

Secondary endpoints examined included mortality and readmission.

Of 7,904 Medicare beneficiaries who underwent major amputation, 46% were above-the-knee amputations. Secemsky reported that, among the study cohort, 5,090 (63.4%) received low-intensity vascular care, 442 (5.5%) received medium-intensity care and 2,500 (31.1%) received high-intensity vascular care.

After multivariable adjustment, being male, being low income or receiving care at a safety-net hospital were all strongly associated with receiving lower-intensity vascular care prior to amputation. Patients who received high-intensity care died at a frequency of 19% vs. 23% among those who received low-intensity vascular care in the two years following amputation, the presenter added.

“We have observed minimal slowin native coronary arteries; coronary flow phenomena, seen with other in-stent restenosis; peripheral BTK and paclitaxel drug-eluting balloons. We arteriovenous fistula indications. have observed several cases of fast In August 2021, the first of over 3,000 wound healing with Selution SLR. It is patients was enrolled in a coronary easy to track and deliver. We are looking randomised controlled study comparing forward to gaining further Seltuion SLR with a clinical experience with limus drug-eluting stent this device,” commented (DES). This is the largest Chong.

DEB study ever initiated “Singapore has a high and has the potential to Percentage of patients percentage of diabetics in change medical practice, a exhibiting freedom its population and CLTI MedAlliance press release from target lesion therefore constitutes states. a major challenge MedAlliance’s DEB revascularisation (TLR) among patients seen technology involves with peripheral arterial MicroReservoirs made from disease (PAD) who biodegradable polymer may benefit from this intermixed with the antitechnology,” commented restenotic drug sirolimus.

Percentage Tang. SGH performs These MicroReservoirs demonstrating over 1,000 interventional provide controlled and amputation-free procedures a year on sustained release of the survival (AFS) patients suffering from drug for up to 90 days.

CLTI, according to a The company claimed MedAlliance press release. that extended release of sirolimus from Selution SLR was awarded CE mark stents has been proven highly efficacious approval for the treatment of PAD in both coronary and peripheral in February 2020 and for the treatment vasculatures. MedAlliance’s proprietary of coronary arterial disease in May 2020. CAT (cell-adherent technology) enables The US Food and Drug Administration the MicroReservoirs to be coated (FDA) has awarded Selution SLR with onto balloons and adhere to the four Breakthrough designations: for vessel lumen when delivered via the treatment of atherosclerotic lesions an angioplasty balloon.

88% 79%

Analysis finds racial differences in presentation and outcomes after peripheral vascular interventions Black patients included in the NCDR-PVI registry—who were younger and had higher rates of comorbidities and lower socioeconomic status than their white counterparts—had significantly higher rates of drug-eluting technology use but were less likely to have surgical or repeat peripheral vascular intervention (PVI) revascularisation in the year after index PVI. THIS WAS THE MAIN FINDING OF late-breaking data presented by Howard M Julien (University of Pennsylvania, Philadelphia, USA) at VIVA. The association between Black race and higher prevalence of peripheral arterial disease (PAD) has been well established, Julien told the audience, noting that, among PAD patients, Black race is independently associated with a greater likelihood of undergoing lower extremity amputation compared with surgical revascularisation.

After accounting for sociodemographic community distress, comorbid conditions, clinical presentation and hospital characteristics, Julien and colleagues aimed to evaluate whether the employment of drugeluting technologies, atherectomy and intravascular imaging during PVI procedures differed between Black and white patients in the NCDR-PVI registry.

Key data

Among 63,150 patient cases, the presenter reported that Black patients were younger (67.9 vs. 70 years), had higher rates of hypertension (94.4% vs.

89.5%) and diabetes (63% vs. 46.2%), were less likely to report being able to walk 200m (29.1% vs. 24.8%) and had higher Distressed Community Index scores (65.1 vs. 50.6). Black patients had higher use of drug-eluting technologies (adjusted odds ratio [aOR], 1.14; 95% confidence interval [CI], 1.06–1.23), with no difference in atherectomy use (aOR, 0.98; 95% CI, 0.91–1.05) or intravascular imaging use (aOR, 1.03; 95% CI, 0.88–1.22).

In Centers for Medicare & Medicaid Services-linked analyses of 7,429 cases (11.8%), Black patients had nonsignificantly greater adjusted hazard ratio (aHR) for major amputation (aHR, 2.50; 95% CI, 0.82–7.63) and were less likely to have surgical (aHR, 0.40; 95% CI, 0.17–0.96) or repeat PV revascularisation (aHR, 0.42; 95% CI, 0.30–0.59) at one year compared to white patients, Julien informed the audience.

Issue 92 | November 2021

New Data 23

Lithotripsy “consistently” treats real-world calcium in multiple peripheral vessel beds

An interim analysis from the DISRUPT PAD III observational study showed that intravascular lithotripsy (IVL; Shockwave Medical) performs “consistently well” across challenging peripheral vessels, lesions and subgroups of patients, Ehrin J Armstrong, medical director at Adventist Heart and Vascular Institute in St Helena, USA, told a clinical trials late-breaking session at Vascular Interventional Advances (VIVA) 2021 (5–7 October, Las Vegas, USA).

ANALYSIS OF THE FULL DATA SET contained in the study—reputedly the largest angiographic core lab adjudicated real-world evidence for IVL in heavily calcified peripheral arteries according to Shockwave Medical—is due to be presented next year.

Findings from the first 752 patients included in the interim analysis demonstrated that IVL “consistently” showed its ability to safely and effectively modify superficial and deep calcium across multiple vascular beds, lesion types and in patients with chronic limbthreatening ischaemia (CLTI), Armstrong reported.

IVL resulted in consistent reduction in the diameter of stenosis with no associated distal embolisation, abrupt closure or thrombotic events at any time, according to Shockwave.

“Patients with heavy calcification have traditionally been excluded from endovascular treatment trials resulting in little available evidence to provide guidance for treating this challenging patient population,” said Armstrong. “The DISRUPT PAD III [observational study] shows that in common clinical situations that physicians encounter daily, peripheral IVL performs consistently well in a variety of peripheral vessels, lesions and subgroups.”

Of the 852 lesions treated in the iliac, common

femoral, superficial femoral, popliteal and infrapopliteal arteries, 88% presented with moderate/ severe calcification, with an average calcified length of 127mm. The use of IVL in these lesions resulted in a final residual stenosis of 24%, similar to the DISRUPT PAD III RCT finding of 22%, Armstrong told VIVA attendees.

Patients also experienced minimal procedural

The DISRUPT PAD III [observational study] shows that in common clinical situations that physicians encounter daily, peripheral IVL performs consistently well in a variety of peripheral vessels, lesions and subgroups”

Artio Medical announces firstin-human results for Amplifi vein dilation system

Preliminary clinical results from a first-in-human study assessing the Amplifi vein dilation system (Artio Medical) were presented at VIVA. Data were presented by Surendra Shenoy—an associate professor of surgery at the Washington University School of Medicine at Barnes-Jewish Hospital in St Louis, USA—during the event’s final late-breaking clinical trial session.

T

he Amplifi system is designed for percutaneous placement and up to 14 days of use to stimulate arm vein enlargement in haemodialysis patients using rapid, non-pulsatile, venous blood flow. Data presented at VIVA came from the first five patients treated in a prospective, nonrandomised, single-arm, first-in-human clinical study with the Amplifi system, and demonstrated that forearm and upper arm mean cephalic vein diameters had more than doubled over an average treatment period of 8.6 days.

Arteriovenous fistulas (AVFs) were successfully created using treated veins in all patients. Maturation data are available for the first three patients and show that both the forearm and upper arm AVFs matured quickly with mean outflow vein diameters of 7mm and a

mean blood flow rate of more than 1,000 ml/min after a six-week maturation period. No device-related or procedural adverse events were observed.

“Not long after AVFs were first pioneered for haemodialysis in 1966 by doctors Cimino, Brescia, and Appel, concerns were raised about patients who were not suitable for AVF surgery and the high rate of AVF maturation failure,” Shenoy said.

“Despite these challenges, AVF remains the preferred option for most patients today. The Amplifi system is the first device I have seen that has real potential to address both of these challenges in a major way, to make good on the promise of providing reliable, long-lasting vascular access sites for this unique and vulnerable patient population.”

complications, with only 0.9% and 0.1% of patients experiencing final dissections and perforations, respectively.

“Notably, there were no instances of embolisation, thrombus, no reflow or abrupt Ehrin J Armstrong closure.” The observational study completed enrolment in June 2021 with a total of 1,373 patients.

Dynamic of COVID-19 initially challenging

Late-breaking session panellist Benjamin W Starnes, the chief of Vascular Surgery at the University of Washington (UW) in Seattle, USA, commented: “Your one-year follow-up data happened right in the middle of a pandemic—what was it like to conduct a clinical trial in the setting of a pandemic?”

Armstrong said the dynamic of the COVID-19 virus was initially challenging, explaining: “At our own hospital, it was mandated that the research coordinators not interact with patients for the first few months, so I The use of IVL in lesions conducted a lot of the in the iliac, common follow-up myself. That femoral, superficial being said, our patients with peripheral arterial disease femoral, popliteal and [PAD]—because they have infrapopliteal arteries such complex issues—in resulted in a final some cases we flexed to residual stenosis of doing virtual visits, but we were able to get these patients in in most cases with outstanding follow-up.

Which, to me, really Similar to the DISRUPT demonstrated the versatility PAD III RCT finding of of conducting research, despite dealing with all these different complexities in the setting of a pandemic.”

24% 22%

IN.PACT AV sustained “superior” effectiveness in subgroups with high reintervention rates out to two years Several subgroups of patients treated with the IN.PACT AV drugcoated balloon (DCB; Medtronic) for arteriovenous fistulas (AVFs) demonstrated a “statistically significant” higher rate of target lesion primary patency (TLPP) compared to those who underwent standard percutaneous transluminal angioplasty (PTA) through 24 months, investigators behind the IN.PACT AV Access study have reported.

ROBERT LOOKSTEIN, EXECUTIVE VICE CHAIR IN THE DEPARTMENT of Diagnostic, Molecular and Interventional Radiology at Mount Sinai Health System in New York, USA, delivered the two-year results at VIVA. IN.PACT AV is a prospective, global, single-blinded, randomised controlled trial with 330 participants, with 170 receiving IN.PACT AV DCB and 160 undergoing PTA. The investigators reported that the primary outcome of TLPP—defined as freedom from clinically-driven target lesion revascularisation—in patients with restenotic lesions, radiocephalic and brachiocephalic AVF types, cannulation zone lesions as well as anastomotic lesions treated with the DCB through 24 months was superior to those who received PTA treatment in all cases.

“Benefits were seen in all other subgroups, though sample sizes were small and the treatment effect was not statistically significant,” Lookstein told VIVA attendees.

The results showed higher TLPP with DCB versus PTA based on time-to-event analyses: restenotic lesions (46% vs. 30.2%), radiocephalic AVFs (53.6% vs. 43%), brachiocephalic AVFs (48.5% vs. 27.3%), anastomotic lesions (48.4% vs. 32.7%), and lesions in the cannulation zone (74.2% vs. 18.9%). The greatest TLPP benefit through 24 months was observed in “lesions treated with the smallest balloon diameter sizes”—those treated with balloon diameters of >6mm showed a TLPP of 52.2% in the case of the DCB group vs. 38.9% among PTA patients. Meanwhile, lesions tackled using balloons with diameters ≤6mm saw TLPP rates of 52.1% (DCB) vs. 32.6% (PTA), the data showed.

November 2021 | Issue 92

24 The Hurting Leg: New Data

PROMISE I 24-month results “validate the benefits of the LimFlow system” LimFlow SA has announced 24-month results from the PROMISE I study of the LimFlow percutaneous deep vein arterialisation system, confirming “excellent and sustained outcomes” for both amputation-free survival and wound healing, a press release reports.

The late-breaking data were presented at Vascular Interventional Advances (VIVA) 2021 (5–7 October, Las Vegas, USA).

T

o relieve the symptoms of chronic limbthreatening ischaemia (CLTI), patients today are treated primarily with angioplasty or open bypass surgery. In many late-stage patients, however, neither option is feasible due to extensive disease in the target arteries or other anatomical constraints.

The minimally-invasive LimFlow System is designed to bypass blocked arteries in the leg and deliver oxygenated blood back into the foot via the veins in CLTI patients who are facing major amputation and have exhausted all other therapeutic options. No-option CLTI is defined as being ineligible for surgical or endovascular arterial revascularisation as adjudicated by an independent committee of vascular surgeons.

“The presentation of the PROMISE I 24-month results validate the benefits of the LimFlow system,” said Daniel Clair, chair of the Department of Vascular Surgery at Vanderbilt University Medical Center Section of Surgical Sciences in Nashville, USA, and PROMISE I principal investigator. “The high percentage of no-option CLTI patients that remained amputation free at 24-months is a major positive step forward for a condition characterised by high amputation and mortality rates.”

PROMISE I is a multicentre, prospective, single-arm study of the LimFlow system, conducted at seven study centres across the USA. All of the 32 patients Daniel Clair enrolled in the study had non-

healing wounds on the target foot. The primary endpoints were freedom from amputation, amputationfree survival, and survival overall. There were no amputations after day 75 in the study. At 24-months, freedom from amputation remained at 77% with an amputation-free survival of 59%. Three additional deaths within the second year of study resulted in 77% survival (two non-limb-related deaths; one from sepsis due to a non-healing wound in the non-treated foot).

Ninety-two per cent had all wounds classified as healed or healing as adjudicated by an independent core lab.

Technical success was reported at 97%.

“The two-year data from PROMISE I US feasibility study are highly encouraging and send a strong signal

The two-year data from PROMISE I US feasibility study are highly encouraging and send a strong signal about the potential of the LimFlow system to strengthen our mission of no limb left behind”

about the potential of the LimFlow system to strengthen our mission of no limb left behind,” said LimFlow CEO Dan Rose.

“We are swiftly advancing our study of the LimFlow system in the ongoing With an amputation-free PROMISE II US pivotal survival of study in a patient population which is facing a very poor overall prognosis in terms of mortality and quality of life after major limb amputation.

The LimFlow system is designed to help heal wounds and avoid major limb amputation, and we are proud of our mission of ‘No Limb Left Behind’.”

At 24-months, freedom from amputation remained at

77% 59%

LimFlow

Similar two-year patency for claudicants and CLTI patients treated with BioMimics-3D

INSIGHT data show “substantial reduction” of in-stent restenosis with Pantheris system

MIMICS-3D IS A EUROPEAN REGISTRY INVESTIGATING THE outcomes of BioMimics 3D treatment in patients with longer, more complex lesions than previously studied.

MIMICS-3D enrolled 507 patients treated with BioMimics 3D at 23 sites: 76% were claudicants (Rutherford class 1–3) and 24% had CLTI (Rutherford class 4–6). Of these, 34% and 47% were diabetic and 7% and 13% had renal insufficiency, respectively. Respective mean lesion length was 126.3±92.9mm and 130.2±92.7mm, and 54% and 64% of lesions were occluded. An independent clinical events committee adjudicated major adverse events (MAEs), including death and potential devicerelated events.

The primary safety endpoint, a composite of freedom from MAE comprising death, major index limb amputation, or clinically-driven target lesion revascularisation (CD-TLR) through 30 days, was 99% for claudicants and 97% for CLTI patients.

The primary outcome measure for effectiveness (freedom from CD-TLR through 12 months) at one and two years was 92% and 85% for claudicants and 85% and 77% for CLTI. Kaplan-Meier freedom from loss of primary patency (peak systolic velocity ratio ≤2.4) at one and two years (days 365 and 730) was 89% and 80% for claudicants and 81% and 72% for CLTI, respectively. There was no statistical difference in patency between the two groups through two years, although there was a slight trend toward a worse outcome in patients with CLTI.

THE INSIGHT TRIAL IS A multicentre, prospective, single-arm trial conducted at 17 institutions to evaluate the safety and effectiveness of the Pantheris system to reduce in-stent restenosis (ISR) in vascular stents placed in lower extremity arteries.

A total of 97 patients presenting with stent stenosis >70% were enrolled, with 85 having completed a six-month followup clinic visit and 78 completing the one-year visit. The patients had a mean age of 74 years, mean weight of 85.6 kg, and mean height of 165cm; were equally male/female; and were predominantly Caucasian (78%). Most had a history of smoking and were being treated for hypertension, coronary artery disease, and diabetes at the time of enrolment.

A subgroup analysis of the MIMICS-3D trial shows that the benefits of swirling flow previously established in claudicants are also relevant for chronic limb-threatening ischaemia (CLTI) patients.

Sahil A Parikh (Columbia University Medical Center, New York, USA) presented this finding in a late-breaking session at VIVA.

The data collected in the INSIGHT trial document a substantial reduction of in-stent restenosis (ISR) stenosis, with few adverse events related to use of the Pantheris optical coherence tomography (OCT) imaging atherectomy system (Avinger) and measured clinical benefit, Jon George (Einstein Medical Center, Philadelphia, USA) told attendees at VIVA. The ISR occlusions had a mean length of 13cm, none to mild calcification, and a mean stenosis of 85% prior to the procedure. As assigned by the clinical events committee, 97% of patients were free of major adverse events within 30 days postprocedure, and the freedom from target lesion revascularisation was 93% at six months postprocedure and 89% after one year. The anklebrachial index measures improved by 36% and 39% between baseline and 30 days and six months, respectively.

Patients experienced a 71% improvement (reduction) in Rutherford class by six months, with 77% of patients either Rutherford class 0 or 1. As adjudicated by a central core lab, stent stenosis was reduced by 82% after treatment.

Issue 92 | November 2021

KNOCKOUT PE data show “strong safety and efficacy” of EkoSonic endovascular system Boston Scientific announced positive results for the EkoSonic endovascular system (EKOS system) during a late-breaking clinical trial presentation at Vascular Interventional Advances (VIVA) 2021 (5–7 October, Las Vegas, USA).

Data from the KNOCOUT PE registry—established to measure institutional adoption of a lower dose and lowerduration thrombolysis protocol for the EKOS system— confirmed the safety and efficacy of the EKOS system for the treatment of patients with intermediate-high and highrisk pulmonary embolism (PE).

“PE REMAINS A LIFE- threatening and complex disease, but these results provide an opportunity to advance patient care by showcasing evidence that proves a lower drug dose and shorter infusion duration of a thrombolytic agent may result in enhanced safety and efficacy,” said Keith M Sterling (Inova Alexandria Hospital, Alexandria, USA), study principal investigator. “The findings in this registry analysis are very reassuring to physicians making critical evidencebased decisions for their patients in what are oftentimes emergent treatment situations.”

The international registry of 489 patients across 83 centres included data from patients treated with the EKOS system who were provided a lower drug dose and shorter infusion duration of a thrombolytic agent than administered in previous studies, reflecting contemporary clinical practice. In the data, there were no intracerebral haemorrhagic (ICH) events, or brain bleeding events, with a low major bleeding rate of 2.5%, compared to the rate previously observed with systemic thrombolysis treatment.

Results also demonstrated a 23% postprocedure reduction in the main indicator of heart strain from PE, measured as right ventricular to left ventricular diameter ratio (RV/LV).

“The largest prospective body of evidence in the interventional PE space to date”

“As the largest prospective body of evidence in the interventional PE space to date, the KNOCOUT PE registry provides an accurate modern representation of patients with PE

New Data 25 treated with the EKOS system every day,” said Michael R Jaff, chief medical officer and vice president clinical affairs, technology and innovation, Peripheral Interventions, Boston Scientific. “The strong safety and efficacy findings exhibited in this registry add to the existing clinical evidence supporting the EKOS system as a treatment option that physicians can trust, as it is already the most studied interventional device in the PE space.”

The ultrasound technology used by the EKOS system accelerates thrombolysis, minimising the time it takes to treat a patient and lowering the necessary thrombolytic dose, which can result in optimised outcomes and a

lower risk of bleeding.

HI-PEITHO randomised trial begins enrolment

Boston Scientific has commenced enrolment in the HI-PEITHO clinical trial, a collaborative research study with the Pulmonary Embolism Response Team (PERT) Consortium and the University Medical Center of the Johannes Gutenberg University of Mainz (Mainz, Germany) comparing use of the EKOS system in combination with anticoagulation to anticoagulation alone for the treatment of acute, intermediatehigh-risk PE. “I am honoured to be part of this study’s global leadership whose mission

is to bring forth guidelines-informing data that will ensure physicians can feel confident in the most appropriate strategy for treating patients with intermediate-high-risk PE,” said Stavros Konstantinides (University Medical Center of the Johannes Gutenberg University of Mainz), study co-lead principal investigator.

The HI-PEITHO trial will enrol up to 544 patients with confirmed acute, intermediate-high-risk PE at as many as 65 sites in the USA and Europe. The composite primary endpoint is defined as PE-related mortality, cardiorespiratory decompensation or collapse and non-fatal symptomatic and objectively confirmed recurrence of PE.

Issue 92 | November 2021

New Data 27

VENOUS

Thrombolex announces “very exciting” interim RESCUE results Thrombolex recently announced the results of the RESCUE trial’s prespecified interim analysis, of the first 62 evaluable patients, in a late-breaking clinical trials session at Vascular Interventional Advances (VIVA) 2021 (5–7 October, Las Vegas, USA).

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his pivotal trial is scheduled to enrol at least 100 evaluable patients with acute intermediaterisk pulmonary embolism (PE). This trial is evaluating the efficacy and safety of the Bashir and Bashir S-B endovascular catheters (BECs) in the treatment of acute PE under an investigational device exemption (IDE) from the US Food and Drug Administration (FDA).

The Bashir endovascular catheter is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature. It is also now intended for the controlled

Bashir endovascular catheter

Five-year, single-centre VenaSeal outcomes for symptomatic saphenous incompetence revealed Morwan Bahi (Wellington Regional Hospital, Wellington, New Zealand) presented fiveyear results of a retrospective, observational, single-centre study detailing outcomes for all patients with symptomatic lower limb chronic venous insufficiency treated with saphenous vein closure with VenaSeal (Medtronic) cyanoacrylate ablation in a latebreaking session at VIVA. A PRESS RELEASE FROM THE VIVA Foundation states that the researchers detailed outcomes for all patients with symptomatic lower limb

and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature, enabling the restoration of blood flow in patients with venous thrombus.

The goal of RESCUE is to achieve an additional indication for use of these devices in the treatment of acute PE. This prespecified interim analysis was presented by Akhilesh Sista, chief of Interventional Radiology, NYU Langone Health, New York, USA. The analysis included 44 males and 18 females with an average age of 58.5 years; 90.3% had high intermediaterisk PE with both right ventricular dysfunction and elevated biomarkers. Each patient was treated with 7mgs of r-tPA into each pulmonary artery over five hours (a total of 14 mg r-tPA in 58 patients with bilateral PEs and 7mg in four patients with unilateral PEs) at 18 participating centres in the USA. Computed tomography (CT) scan at 48 hours after infusion showed that the right ventricular to left ventricular (RV/LV) diameter ratio decreased by 32.1% (0.52±0.38: 95% confidence interval [CI] 0.42–0.62, p<0.0001), and the pulmonary clot burden by Refined Modified Miller Index had decreased by 36.3% (8.4±4.3: 95% CI 7.34–9.5, p<0.0001). The successful device placement rate was 100%, there were no devicerelated complications and the major bleed rate at 72 hours was zero.

“These interim results from the RESCUE trial are

chronic venous insufficiency treated with saphenous vein closure with VenaSeal between 1 January 2016 and 31 December 2020. All patients were postoperatively reviewed at six weeks, and outcomes were recorded.

Bahi and colleagues identified 235 patients matching their study criteria.

The average age was 60.5 years, with slight male predominance (55.8%). The majority of patients were New Zealand European (63.8%), followed by Maori and Pacific (31.0%).

The most common indication was venous ulceration (57.9%). Other indications included superficial thrombophlebitis, recurrent cellulitis, varicose vein bleeding, and deep vein thrombosis (DVT). Fifty percent underwent bilateral treatment. Only one saphenous vein (greater saphenous vein or small saphenous vein) required treatment in 88% of patients. The most common postprocedure symptom was phlebitis in 49 (21%) patients, which is an expected part of recovery.

Excluding phlebitis, only 33 complications were noted, all relatively minor. The investigators reported 15 cases of residual varicose veins, nine saphenous nerve neuropraxia cases, six cases of wound cellulitis, and three DVTs.

very exciting,” said Sista.

“The most notable finding is the core lab-assessed reduction in pulmonary thrombus burden at 48 hours, which may translate to better short- and longterm outcomes pending further research. The reduction in RV/LV ratio and the absence of device- or drug-related adverse events are also salutary outcomes. The expandable infusion basket of the BECs, with its pharmacomechanical mode of action, appears to restore blood flow promptly. I look forward to the final results of RESCUE and subsequent investigations that will determine the role of this promising novel technology in the treatment of acute PE.” Brian Firth, chief scientific officer of Thrombolex and principal investigator on the Small Business Innovation Research grant from the National Heart Lung and Blood Institute (NHLBI) stated: “The strong support and encouragement that we have received from the NHLBI as we have conducted this trial, especially in the midst of the COVID-19 epidemic, has really made this trial possible. We would also like to acknowledge additional support from the Commonwealth of Pennsylvania, Department of Health.”

CT scan at 48 hours after infusion showed that the RV/LV diameter ratio decreased by

32.1%

I look forward to the final results of RESCUE and subsequent investigations that will determine the role of this promising novel technology in the treatment of acute PE”

Three-year VIVO results back “continued safety and effectiveness” of Zilver Vena Three-year results of the VIVO clinical study support the continued safety and effectiveness of the Zilver Vena venous stent (Cook Medical) in the treatment of symptomatic iliofemoral venous outflow obstruction, a press release from the VIVA Foundation summarises. Paul Gagne (The Vascular Experts, Darien, USA) presented the new data in a late-breaking session at VIVA. PATIENTS WITH SYMPTOMATIC OBSTRUCTION OF ONE iliofemoral venous segment were enrolled (i.e. Clinical, etiology, anatomy, pathophysiology [CEAP] clinical classification ≥3 or Venous Clinical Severity Score [VCSS] pain score ≥2). Follow-up through three years included measures of patency, reintervention, clinical outcomes (measured by VCSS, vascular duplex scan [VDS], CEAP “C”, and Chronic Venous Insufficiency Questionnaire [CIVIQ]), and device integrity measures of fracture and migration.

The VIVO study enrolled 243 patients (70% female; mean age, 53±15 years; 67.5% with current or past deep vein thrombosis). The 30-day primary safety endpoint and 12-month primary effectiveness endpoint were met, exceeding the corresponding performance goals (p<0.0001), and improvement in clinical outcome measures was demonstrated at 12 months (p<0.0001).

Follow-up through three years is complete, Gagne told VIVA attendees, reporting that results observed at 12 months were maintained. Specifically, three-year outcomes include high rates of patency by ultrasound (90.3±2.2%), freedom from clinically-driven reinterventions (92.6± 2%), and freedom from reinterventions (82.9±2.6%). Clinical improvement, as measured by VCSS, VDS, CEAP “C”, and CIVIQ, was sustained through three years (p<0.0001).

November 2021 | Issue 92

28 Interview

Position paper highlights renal denervation as a third option for hypertension management The European Society of Hypertension (ESH) presented an updated position paper on renal denervation during the eighth pre-ESH congress satellite symposium (10–11 September; Athens, Greece). The paper was recently published in the September issue of the Journal of Hypertension.

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enal denervation is a minimally invasive procedure intended to regulate overactivity of nerves that lead to and from the kidney, which play an important role in controlling blood pressure. In recent sham-controlled randomised trials and registries, clinically favourable effects of renal denervation have been consistently demonstrated across a wide spectrum of patients with uncontrolled hypertension, in the absence and presence of prescribed anti-hypertensive medications.

The position paper confirms that renal denervation is considered a safe endovascular procedure without significant short-term or long-term adverse effects based on data available up to three years.

“In light of the recent publication of several secondgeneration sham-controlled clinical trials, we thought it was important to provide an updated position paper on

renal denervation and its role in treating uncontrolled hypertension,” said Roland Schmieder, professor of Internal Medicine, Nephrology and Hypertension at the University Hospital Erlangen, Erlangen, Germany and chairman of the ESH working group on interventional treatment of hypertension.

“Renal denervation represents an evidence-based option to treat hypertension, in addition to lifestyle changes and blood pressure lowering drugs. Renal denervation expands therapeutic options to address the first objective of hypertension treatment, to effectively reduce elevated blood pressure and achieve blood pressure targets,” said Konstantinos Tsioufis, professor of Cardiology at the University of Athens, Athens, Greece, immediate past president of ESH. “Heightened cardiovascular risk such as evident organ damage or established disease like coronary artery disease or heart

Renal denervation: The most advanced and efficacious interventional approach to treat hypertension Following the release of the European Society of Hypertension’s (ESH’s) updated position paper on renal denervation, Konstantinos Tsioufis, professor of Cardiology at the University of Athens, Athens, Greece and immediate past president of ESH, discusses the use of renal denervation in the treatment of hypertension, considers the latest evidence in favour of the approach, and outlines the questions still to be answered.

What are the advantages of using renal denervation to treat hypertension?

In all recent sham-controlled trials there were clinically favourable effects of renal denervation for treatment of uncontrolled hypertension. The great advantage is that the intervention has shown meaningful office and ambulatory blood pressure decrease across multiple phenotypes of patients with mild to moderate, as well as more severe, hypertension in the presence and absence of medication.

This constant reduction in blood pressure over 24 hours—the “always on” impact—of renal denervation differentiates the intervention-induced changes in blood pressure from those by drugs due to the diverse pharmokinetic profiles and dosing regiments along with patient nonadherence.

How does renal denervation compare to other treatment approaches that are available?

According to latest second generation randomised controlled trials and the Global SYMPLICITY Registry (GSR), average blood pressure reduction

induced by renal denervation compared to sham ablation is 8-10mmHg in office systolic blood pressure reading and 5-7mmHg in ambulatory systolic blood pressure readings. Other interventional approaches to modulate sympathetic tone by baroreceptor activation is still under investigation.

What do trial data tell us about this approach and its outcomes in the longterm?

The antihypertensive effect of renal denervation is durable and, taking into consideration the average drop of 10mmHg in office blood pressure, the effect can be translated to significant improved cardiovascular prognosis (approximately 20% reduction in cardiovascular events and 26% in stroke). It is also an early and late-term safe procedure with minimal complications based on data from registries and recent sham randomised controlled trials. The observed blood pressure reduction is maintained long term with data available up to three years after the Konstantinos procedure.

Tsioufis

failure might be pointing towards treatment priority with renal denervation in hypertension. Additionally, patients who are unable or unwilling to take medication might be another renal denervation group, especially in the first stages of the hypertensive disease.”

Arterial hypertension constitutes the most prevalent and important risk factor for cardiovascular morbidity and mortality globally despite the availability of pharmacological treatments. In addition, approximately half of individuals with hypertension do not meet guideline-directed blood pressure goals.

“Many patients with uncontrolled hypertension struggle to adhere to lifelong drug therapy for a variety of reasons and may look to other options that complement traditional treatments,” said Reinhold Kreutz, professor of Clinical Pharmacology and Hypertension at the Charité Universitaetsmedizin, Berlin, Germany, and president of ESH. “We believe this advance could help clinicians work with patients to better manage their high blood pressure.”

Are there any unanswered questions to be investigated?

Currently there is an urgent need to define predictors of blood pressure response post renal denervation and there are efforts focusing on diverse parameters both clinical and laboratory.

There are data showing that in untreated patients with higher baseline heart rate and plasma renin aldosterone levels renal denervation are associated with better blood pressure reduction.

Moreover, the average and standard deviation of night-time ambulatory blood pressure has been identified as a potential robust predictor, which requires further research.

Another question is the long-term durability of blood pressure lowering and safety beyond three years as well as safety and efficacy in patients with comorbidities such as renal failure.

Further studies are also needed exploring the renal denervation-induced clinical impact in patients with heart failure (HF), atrial fibrillation (AF) and increased overall cardiovascular risk.

The cost-effectiveness of the procedure for healthcare systems is an additional point that will also need to be addressed.

Are there any drawbacks to this approach?

Given the established efficacy and safety the only drawback for renal denervation is physicians’ inertia to consider and refer hypertensives for this approach.

Additionally, there is a lack of information on the clinical impact of neuromodulation from the standpoint of hypertensive patients that limits the implication of the technology to everyday practice.

How should physicians evaluate which patients are suitable for renal denervation treatment for hypertension?

According to the latest evidence, the criteria for considering hypertensive patients for renal denervation is persistent uncontrolled hypertension despite guideline-based therapy including ameliorated lifestyle measures and efforts to increase adherence.

Heightened cardiovascular risk or established disease might be pointing towards treatment priority with renal denervation in hypertension.

Additionally, patients who are unable or unwilling to take medication might be another renal denervation group, especially in the first stages of the hypertensive disease. The shared decision-making process is important for renal denervation and according to patients’ preferences this interventional approach could be selected for diverse phenotypes of hypertension.

Do you see renal denervation as having a significant role to play in the future treatment of hypertension?

Renal denervation constitutes today the most advanced and efficacious devicebased interventional approach to treat hypertension, expanding therapeutic options as an alternative and not as a competitive strategy. This would be of important clinical value since approximately half of individuals with hypertension do not meet guidelinedirected blood pressure goals. Based on the available evidence, renal denervation is definitely included in the individualised treatment strategy of the future for better hypertension control and reduction of overall cardiovascular disease burden.

Konstantinos Tsioufis

November 2021 | Issue 92

30 Market Watch

Product News Terumo Aortic announces PMDA approval and first commercial implant of Treo endovascular device in Japan

Following the recent approval by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) of the Treo abdominal aortic stent graft system for sale in Japan for the treatment of patients with abdominal aortic aneurysm (AAA), Terumo Aortic recently announced the first commercial implant of this device in Japan.

This first implant was undertaken by Takao Ohki, chairman of the Department of Surgery, professor and chief of the Division of Vascular Surgery, Jikei University School of Medicine, Tokyo, Japan. Ohki commented: “The procedure was very successful, the device performed well, and the patient is making a good recovery. The major concerns in endovascular surgery are stent migration and endoleaks; the Treo device provides both suprarenal and infrarenal fixation allowing for distribution of the stent graft fixation in two different anatomical levels and is expected to result in superior long-term outcomes. In addition, the Treo device is sophisticated and very user friendly with a smooth, kink-resistant detachable sheath that definitely improves the accuracy and safety of the procedure.”

BD announces 510(k) clearance of expanded indications for the Rotarex atherectomy system

BD recently announced it has received 510(k) clearance for expanded indications from the US Food and Drug Administration (FDA) for the Rotarex atherectomy system.

The Rotarex atherectomy system is a rotational excisional device that is built to remove and aspirate varying lesion morphologies including plaque

Rotarex atherectomy system

and thrombus in the peripheral arteries.

The Rotarex system, already cleared for use in native arterial vessels, now has the expanded indications to treat within peripheral arteries fitted with stents, stent grafts, and native or artificial bypasses.

“The Rotarex atherectomy system is quick and efficient for treating arterial lesions,” said Prakash Krishnan, a cardiologist at the Icahn School of Medicine at Mount Sinai in New York,

USA. “With ability to use it for both atherectomy and thrombectomy, it is now a great product to be able to treat in-stent restenosis. Rotarex has been a great device for me to have in my practice, and I am excited about these new indications.”

The FDA clearance of the Rotarex atherectomy system’s new expanded indications follows more than 10 years of real-world clinical experience involving the treatment of thousands of patients globally. Now, physicians can use a proven tool to address some of their most challenging peripheral arterial disease (PAD) lesions, including the treatment of in-stent restenosis.

“I have had the ability to use the Rotarex atherectomy system for over 10 years both within and outside the USA,” said Miguel Montero-Baker, a vascular surgeon at Baylor College of Medicine in Houston, USA. “This indication expansion is exciting and will allow me to utilise a device I trust to care for my complex PAD patients.”

ReCor Medical’s Paradise ultrasound renal denervation system used in first German cases

ReCor Medical has announced that its Paradise ultrasound renal denervation system is now available for the treatment of uncontrolled hypertension in Germany. The first hospitals performing the procedure commercially are Heart Center Leipzig, Leipzig and Saarland University Hospital, Homburg/ Saar.

“Despite the availability of antihypertensive medications, many patients fail to control their hypertension, a dangerous condition that can lead to heart attack and death.

Clinical data from the ACHIEVE, RADIOSOUND, RADIANCE-HTN SOLO and TRIO trials show that ultrasound renal denervation with the Paradise system can lower blood pressure and is a new treatment option for physicians to help their selected patients,” said Felix Mahfoud of Saarland University Hospital and chairman of the Arterial Hypertension Working Group of the German Society of Cardiology (DGK), who served as study investigator for the RADIANCEHTN SOLO and TRIO trials. “We are pleased to be one of the first hospitals in Europe to offer renal denervation with ultrasound.”

In Leipzig, the first procedure was successfully performed at the Heart Center Leipzig at the University Clinic for Cardiology. There, Philipp Lurz and Karl Fengler led the RADIOSOUND trial, and both have participated in the RADIANCE-HTN SOLO and TRIO studies in patients with uncontrolled hypertension.

Paradise ultrasound renal denervation is a device-based, minimally invasive

procedure for the treatment of high blood pressure. During the procedure, which usually takes less than an hour, the Paradise catheter is placed in the renal artery. Typically, three doses of ultrasound energy lasting a few seconds are applied to each of the main arteries leading to the kidneys. The ultrasound emissions denervate the renal nerves and cause a reduction in sympathetic nervous system activity, which can result in lower blood pressure.

In September 2021, the European Society of Hypertension published an updated position paper stating that renal denervation “is effective in reducing or interrupting the sympathetic signals to the kidneys and decreasing whole body sympathetic activity.” The society noted that five independent sham-controlled randomized clinical trials—including RADIANCE-HTN SOLO and TRIO— provide “conclusive evidence” that renal denervation can lower ambulatory and office blood pressure both in patients with and without concomitant antihypertensive medication.

“The Paradise System has generated a significant body of clinical evidence in the ACHIEVE, RADIOSOUND, RADIANCE-HTN SOLO and TRIO studies—executed over a number of years in centres across the USA and Europe—showing a significant lowering of blood pressure in patients with uncontrolled hypertension,” said ReCor president and CEO Andrew M Weiss.

Hypertension is one of the leading contributors to disease burden worldwide, leading to increased cardiovascular morbidity and mortality, impaired quality of life, and increased cost to health systems. Based on meta-analyses of randomised trials using pharmacological treatments, a decrease of 10mmHg in office systolic blood pressure is estimated to lower the incidence of cardiovascular events by 20%. Despite the broad availability of antihypertensive medications, access to drugs and adherence remain challenging for patients and physicians.

The Paradise system is an investigational device in the USA. ReCor is currently conducting a US Food and Drug Administration (FDA) investigation device exemption (IDE) pivotal study (RADIANCE-II) in patients with uncontrolled hypertension.

First patient treated with Cardiovascular Systems’ ViperCross peripheral support catheter

Cardiovascular Systems recently announced that the first patient has been successfully treated with its ViperCross peripheral support catheter.

Billy J Kim (The Surgical Clinic, Nashville, USA), treated the first patient with ViperCross.

Kim remarked: “ViperCross offers the right balance of support and flexibility to successfully navigate tortuous anatomy and cross challenging lesions. In addition, ViperCross provides excellent guidewire support and facilitates easy guidewire exchange.”

Peripheral support catheters are used

during peripheral vascular intervention (PVI) procedures for guidewire support to enable lesion crossing, as well as for guidewire exchanges. Physicians use support catheters in approximately 50% of PVIs, primarily in belowthe-knee and complex interventions.

When calcium is present, lesions can be challenging to cross with an interventional guidewire and often require advanced tools prior to vessel preparation and treatment.

Scott R Ward, chairman, president and chief executive officer of CSI, commented: “With the commercial launch of ViperCross, CSI now offers a complete portfolio of products for the treatment of peripheral arterial disease, including atherectomy, balloon catheters, guidewires, support catheters and embolic protection. Combined, these products advance our ability to help physicians improve outcomes for patients undergoing complex peripheral interventions.”

Surmodics announces successful first patient uses of Sublime radial access 0.018 RX PTA dilatation catheter

Surmodics has announced the successful first clinical uses of the Sublime radial access 0.018 RX percutaneous transluminal angioplasty (PTA) dilatation catheter.

Ankur Lodha, perfomed the first procedures with the device at Cardiovascular Institute of the South’s office-based catheterisation lab in Lafayette, USA. Subsequently, Imraan Ansaarie, utilised the Sublime radial access 0.018 RX PTA dilatation catheter in cases at Advanced Endovascular Institute of St Augustine in St Augustine, USA. The device is the latest addition to the Sublime radial access platform, joining the Sublime radial access guide sheath and the Sublime radial access 0.014 RX PTA dilatation catheter.

“Sublime radial access RX PTA dilatation catheters will allow physicians to treat the most distal blockages in the foot with just radial access. This will help us perform more complex interventions via this approach which was not possible prior,” said Lodha.

Medtronic receives CE mark approval for radial artery access portfolio

Medtronic recently announced it has received CE mark approval for its radial artery access portfolio, which includes the Rist radial access selective catheter and the Rist 079 radial access guide catheter—the first catheter specifically designed for the unique demands of accessing the neurovasculature to treat stroke, brain aneurysms and other conditions through the radial artery versus access through the transfemoral artery, according to a company press release.

The Rist 079 radial access guide catheter is 510(K) cleared by US Food and Drug Administration (FDA) and has been in use at limited sites in the USA, receiving strong customer

Issue 92 | November 2021

Market Watch 31

Product News feedback in more than 100 cases on its outperformance in navigability and support for the radial pathway, the release adds.

“With excellent navigability, this first-of-its-kind device will allow clinicians to reach distal locations while still achieving excellent stability to the system,” said Alejandro Tomasello, head of the Interventional Neuroradiology Unit at Vall d’Hebron Hospital in Barcelona, Spain. “The radial artery access portfolio works well in tandem with Phenom PLUS, Phenom 021 microcatheter for stent deployment or Phenom 027 microcatheter for flow diverter deployment, which is a fantastic set up for the Pipeline Vantage embolisation device with Shield technology treatments [all Medtronic].”

Transradial techniques have been the standard of care in the cardiac interventional community since the American Heart Association (AHA) recommended a radial-first approach for acute coronary syndrome in 2018, citing lower bleeding and vascular complications than transfemoral artery access.

Other advantages demonstrated in cardiovascular procedures to radial access include strong patient preference, immediate ambulation

and reduced costs, which have led the neurointerventionist community to examine adoption of the transradial approach to their practice, the release also states.

Gore’s lower profile delivery Viabahn endoprosthesis gets EMEA launch Gore has announced the EMEA launch of the lower profile, large diameter Viabahn endoprosthesis with Propaten bioactive surface.

The device enhancements build on a market-leading stent graft device, which has become an important tool for treating complex vascular disease, Gore said in a press release. According to the company, the device design reduces the delivery profile for larger 9–13 mm diameter stent grafts by up to

Viabahn endoprosthesis with Propaten bioactive surface

3Fr, enabling delivery through smaller sheaths. Smaller introducer sheaths have resulted in a lower risk of vascular access complications in select patient populations.

New radiopaque markers, now also on the larger diameter device configurations, enhance visualisation under fluoroscopy, facilitating positioning and device delivery, as well as precise and predictable placement, the company added.

“In addition to the radiopaque markers that facilitate positioning and deployment, the new lower profile enables use of a smaller sheath, potentially reducing the risk of damage at the access site,” said Manuel Alonso, vascular surgeon, Oviedo, Spain.

“Combined with the trackability and flexibility this new lower profile offering will become very instrumental for treating complex patients across disease states in my practice.”

Terumo Aortic announces first implant of landmark thoracoabdominal hybrid device

Terumo Aortic has announced the successful implantation of the company’s first custom-made thoracoabdominal hybrid device to treat thoracoabdominal aortic disease.

The world’s first thoracoabdominal repair procedure using a hybrid open stent graft was carried out by Sebastian Debus and supported by Sabine Wipper at University Heart

Centre Hamburg (Hamburg, Germany).

This procedure represents a key stage in the development of a device for the treatment of patients with thoracoabdominal aortic disease using minimally invasive surgical techniques.

Utilising technology from the company’s existing hybrid portfolio, the custom-made thoracoabdominal hybrid device incorporates a combination of Terumo Aortic’s Gelweave woven surgical and unique stent graft technology to address the patient’s specific anatomy.

Debus, chairman of the Department of Vascular Medicine, University Heart Centre Hamburg, commented: “This unique hybrid graft was designed in collaboration with Terumo Aortic to reduce the risk of complications associated with thoracotomy and extracorporeal circulation. The device consists of a proximal stent graft for transabdominal retrograde delivery to the descending aorta combined with a distal six-branched abdominal device for open abdominal aortic repair. The preliminary end-to-side anastomosed branch to the iliac artery allows continuous retrograde flow to the distal aorta following proximal stent graft deployment, and visceral vessels are subsequently anastomosed. This is the ‘first-in-human’ device implanted; it was easy to implant and the procedure was uneventful and straightforward.

The patient showed ‘fast track’ recovery and postoperative course was without complications.”

Issue 92 | November 2021

Market Watch 33

BIOPACT head-to-head non-inferiority randomised controlled trial completes enrolment

Clinical News Endologix initiates randomised study of Alto abdominal stent graft system

Endologix recently revealed that the first patient has been enrolled in the company’s JAGUAR study to compare outcomes for the Alto abdominal stent graft system to other commercially available endovascular aneurysm repair (EVAR) devices for the treatment of abdominal aortic aneurysm (AAA).

JAGUAR (Objective analysis to gauge EVAR outcomes through randomisation in a real-world population) is a prospective, randomised, multicentre study that will enrol approximately 450 patients at up to 60 sites worldwide. The study is designed for at least 300 patients to be randomly allocated to the Alto cohort and 150 to the comparator group.

All patients will be followed through five years. Results from the study will be independently adjudicated by a third party.

“The availability of compelling clinical evidence for EVAR devices is crucial for making informed treatment decisions and improving patient outcomes,” said Jean Panneton, vascular surgeon with Sentara Vascular Specialists (Norfolk, USA) who treated the patient at Sentara Norfolk General Hospital (Norfolk, USA).

Alto abdominal stent graft system

JAGUAR has two primary endpoints: a clinical endpoint and an imaging endpoint. The clinical endpoint is a composite of aneurysm-related complications and consists of freedom from device-related interventions, conversion to open surgery, Type I and III endoleaks, clinically significant device migration, aneurysm enlargement, occlusion, aneurysm rupture and aneurysm-related death. The imaging endpoint is related to proximal neck dilation over time and allows for early insight into mechanisms of graft failure.

“Endologix is committed to investing in clinical evidence,” said Matt Thompson, chief medical officer of Endologix. “JAGUAR joins our LEOPARD study as the only two randomised clinical trials designed to evaluate comparative endograft performance. We believe that this real-world study will provide valuable insights to inform EVAR treatment decisions and improve patient outcomes.”

First patient enrolled in BIONETIC-I study of iliac artery treatment with Biotroniks’s Dynetic-35 stent system

Biotronik has announced the first patient enrolment in the BIONETIC-I study of the safety and efficacy of the Dynetic-35 cobalt chromium balloon-expandable stent system for the treatment of atherosclerotic peripheral arterial disease (PAD) lesions in the iliac arteries.

The study will also evaluate the use of the stent system in association with Biotroniks’s Passeo-35 Xeo peripheral dilatation catheter. The first patient was

The investigator-initiated BIOPACT randomised controlled trial (RCT) has completed enrolment, Biotronik recently announced. This noninferiority study evaluates the safety and efficacy of paclitaxel drug-coated balloons (DCBs), comparing the Biotronik Passeo-18 Lux paclitaxelreleasing percutaneous transluminal angioplasty (PTA) balloon catheter to the IN.PACT Admiral paclitaxel-coated PTA balloon catheter (Medtronic).

The study enrolled 302 patients in Austria, Belgium, France and Switzerland and will collect follow-up at one, six, 12, 24, 36, 48 and 60 months.

Patients with Rutherford class 2–4 disease were randomized 1:1 to either the Passeo-18 Lux DCB or IN.PACT Admiral DCB for the treatment of stenotic, non-stented restenotic or occlusive lesions in the femoropopliteal artery. A non-inferiority hypothesis will be tested to compare the clinical performance of Passeo-18 Lux to IN.PACT Admiral.

Dynetic-35 stent

enrolled by investigator Koen Keirse, vascular surgeon at the Tienen Medical Center in Tienen, Belgium.

The prospective, international, multicentre, single-arm, observational study will evaluate treatment of iliac lesions in approximately 159 patients with up to 60-month follow-up. The primary endpoint is major adverse events (MAEs) at 12 months. MAEs include device- or procedure-related death within 30 days post-index procedure, clinically-driven target lesion revascularisation and major index limb amputation up to 12 months post-index procedure.

“I was impressed by the performance of the latest balloon-expandable iliac stent on the market. The cobalt chromium structure is, to me, very important,” said Keirse. “I am sure that the Dynetic-35 stent’s unique characteristics and fantastic size range— including stents up to 78 mm—will be of added value in many cath labs.”

“I am enthusiastic to collect new clinical data to add to the body of literature regarding iliac artery baremetal stenting, as we have not had new data in this field for some time,” added principal investigator Marianne Brodmann, head of the Clinical Division of Angiology, Department of Internal Medicine at the Medical University Graz in Graz, Austria.

The next-generation Dynetic-35 iliac stent system, which was launched in the EU and other CE mark-accepting countries last year, is 6Fr compatible across the entire size matrix, and is indicated for the treatment of de novo or restenotic lesions in the iliac arteries.

Passeo-18 Lux DCB

The primary efficacy endpoint is freedom from clinically-driven target lesion revascularisation at 12 months post-procedure. The primary safety endpoint is a composite of freedom from device- and procedure-related death through 30 days post-index procedure, freedom from major target limb amputation and clinically-driven target vessel revascularisation through 12 months post-index procedure. Key secondary endpoints include primary patency, major target limb amputation and all cause of death.

“I am thrilled about this milestone for the BIOPACT RCT and thank all of our investigators for their participation and contribution to the fast enrolment despite the pandemic-induced challenges in patient care over the last year and a half,” said principal investigator Koen Deloose (AZ Sint Blasius Hospital, Dendermonde, Belgium). “Having more head-to-head data is critical to better understand differences in device design and drug dosage and the more data we can add to the safety debate of paclitaxel-coated balloons, the better.

We eagerly await the follow-up results of this trial.”

“This head-to-head clinical trial will add to the already extensive evidence supporting our Passeo-18 Lux DCB,” said Alexander Uhl, president Vascular Intervention at Biotronik. “We look forward to these data confirming Passeo-18 Lux’s position amongst the

leading DCBs.” The primary endpoint is intended to be presented upon completion of 12-month follow-up in late 2022.

Terumo Aortic announces launch of landmark global surgical graft study

Terumo Aortic has announced the launch of the company’s global surgical graft study known as PANTHER. This study is a prospective and retrospective, multicentre, multi-arm, postmarket study of the company’s range of knitted and woven surgical grafts and cardiovascular patches.

According to a press release, the PANTHER study is the first of its kind in the world and represents a significant commitment to the extensive collection of data on the company’s open surgical grafts and cardiovascular patches across a large number of geographies.

One of the key aims of the study is to demonstrate the long-term clinical performance of open surgical grafts.

The study will start with over 30 sites primarily in Europe and North America.

There are five defined cohorts as outlined in the study protocol with each group representing a specific product family; approximately 900 patients will be enrolled and followed for more than 10 years. Future expansion of the study to include new products is anticipated bringing total enrolment to over 1,500 patients.

Lijckle van der Laan (Amphia Hospital, Breda, The Netherlands) enrolled the first patient in Europe and commented: “The PANTHER study is an exciting opportunity to gather long-term follow-up data on surgical

Gelweave Plexus

grafts used to treat a wide range of cardiothoracic and vascular pathologies.

I am not aware of this type of data having been recorded previously in relation to the scope of this study and it will provide physicians with a far better understanding of the clinical behaviour of these surgical grafts.”

In the USA, principal investigator Daniel Newton (Virginia Commonwealth University School of Medicine, Richmond, USA) added: “We are delighted to have enrolled the first patient in the USA. We look forward to contributing to this global study and collecting data on grafts and patches implanted for open surgery. To date, the majority of studies on surgical grafts are limited to short-term follow-up and the study will be a significant step towards understanding long-term outcomes.”

November 2021 | Issue 92

34 Market Watch

Industry News Joerns Healthcare introduces point-of-care imaging to wound care portfolio through MolecuLight partnership

Joerns Healthcare, a healthcare technology and equipment services company, announces the addition of the MolecuLight i:X and DX wound imaging platforms to its wound management portfolio through an agreement with MolecuLight to provide MolecuLight’s fluorescence imaging technology for point-of-care detection of the bacterial burden in wounds.

Boston Scientific announces agreement to acquire Devoro Medical

Boston Scientific recently announced an agreement to acquire Devoro Medical, developer of the Wolf thrombectomy platform. The nonconsole and lytic-free Wolf technology targets and captures blood clots using finger-like prongs that retrieve and remove thrombi in the arterial and venous systems.

“The addition of the Wolf platform advances our efforts to ensure physicians have the right tools to

improve procedural efficiencies,” said Jeff Mirviss, executive vice president and president, Peripheral Interventions, Boston Scientific. “Clot management remains a core focus of our business, and upon commercialisation, this highly differentiated technology will complement and expand our offerings to a full suite of interventional strategies for thromboemboli, which also includes the EkoSonic endovascular system (EKOS) and the AngioJet thrombectomy system.”

Boston Scientific has been a strategic investor in Devoro Medical since 2019 and currently holds an equity stake of approximately 16%. As a result, the transaction consists of an upfront payment of approximately US$269

million for the 84% stake not yet owned and up to US$67 million upon achievement of certain clinical and regulatory milestones.

“The Wolf platform is a compelling new option for physicians performing thrombectomy procedures and, importantly, it is designed to target and remove clots without damaging blood vessels, while also minimising blood-loss, which may improve outcomes,” said Michael R Jaff, chief medical officer and vice president of clinical affairs, technology and innovation, Peripheral Interventions, Boston Scientific. “We look forward to accelerating the progress of this platform technology so that we help patients who are dealing with these common, yet challenging health conditions.”

Nectero Medical completes US$19.5 million Series C financing

Nectero Medical has announced the closing of its US$19.5 million Series C financing round, led by new investor Boston Scientific Corporation.

Proceeds will support the company’s in vivo and clinical trials to develop a potentially disruptive treatment platform that stabilises small- to mid-sized aortic aneurysms by significantly reducing their growth rate.

A press release from the company states that Nectero’s initial application,

the Endovascular aortic stabilisation treatment (EAST), has demonstrated impressive early clinical results suggesting the potential to dramatically inhibit abdominal aortic aneurysm (AAA) disease growth. The EAST system is expected to prevent rupture and inhibit further degradation of the aortic tissue with a simple, one-time catheter-based procedure that locally delivers a proprietary compound and.

The system is now treating AAA patients in a multisite Phase 1 safety study. “For small- to mid-sized aneurysms, ‘active surveillance’ is the current standard of care,” said Jack Springer, CEO of Nectero Medical. “Unfortunately, these patients are not without risk of rupture, yet they are not eligible for treatments with surgical repair or endovascular grafts due to complications associated with these procedures. We expect our EAST system to satisfy this compelling unmet clinical need.”

Calendar of events Please be advised that the events listed opposite, because of COVID-19, are subject to change. Please check the relevant website for further details as the event may be cancelled, postponed, or become a virtual event.

2021

2022

16–20 November VEITHsymposium 2021 Orlando, USA

31 January–3 February Leipzig Interventional Course (LINC) 2022 Leipzig, Germany & virtual

www.veithsymposium.org

1–3 December The Vascular Societies’ Annual Scientific Meeting (VSASM) 2021 Manchester, UK

www.vascularsociety.org.uk/vsasm_2021.aspx

2–4 December VERVE Symposium Sydney, Australia

www.vervesymposium.com

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2019 | Issue

83

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

6–8 March 25th European Vascular Course (EVC) Maastricht, The Netherlands www.vascular-course.com/

26–28 April Charing Cross (CX) Symposium 2022 London, UK & virtual

15–18 June Society for Vascular Surgery (SVS) Vascular Annual Meeting 2022 Boston, USA www.vascular.org/vam

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

www.cxsymposium.com/cx2022/

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