Vascular News 86 – July 2020 US Edition

July 2020 | Issue 86

Vascular education goes virtual in the COVID-19 era The COVID-19 pandemic has changed the world as we know it. To continue vascular education during a time of worldwide travel restrictions and social distancing measures, societies and organisations have rallied to keep the discussion going virtually. The digital version of this year’s Charing Cross (CX) Symposium—CX 2020 LIVE—took place over 10 sessions from 26 May to 25 June, covering the latest research and current debates in vascular surgery. This year, the agenda covered the ongoing debate surrounding the use of paclitaxel in below-the-knee vessels, early, yet promising, results with fibre optic visualisation of complex aortic procedures, developments in the venous field, and new technologies for vascular access. During the course of five weeks, over 6,000 registrants logged in to the livestream from more than 120 countries to take part in live discussion, participate in polling, and pose questions to the experts.

T

he first week of CX 2020 LIVE covered the paclitaxel controversy (see page 28), unresolved since the Katsanos et al meta-analysis of December 2018, followed by a session (see pages 12–14) on the durability of endovascular aneurysm repair (EVAR), sac diameter, and UK National Institute of Health and Care Excellence (NICE) guidelines, published in March 2020. Subsequent weeks included two sessions of Podium 1sts, covering the latest developments in the aortic (see page 8) and peripheral arterial spaces (see pages 29–30).

Other highlights include the aortic arch discussion, which emphasised the importance of underlying pathology and the benefit of a multidisciplinary team (see page 10), the vascular access session, which covered early results with new technologies and the continuing debate on the place of endovascular fistula creation (see page 25), and the Juxtarenal Aneurysm Consensus session, in which surgeon-modified and custom-made endografts carved their place in treatment (see page 16).

SVS presidency passed virtually for the first time

Another key event on the vascular calendar, the Society for Vascular Surgery (SVS) Vascular Annual Meeting (VAM), also went virtual this year, in lieu of its annual June meeting. This year, SVS ONLINE: “New advances and discoveries in vascular surgery” ran from 20 June to 2 July and, for the first time, the presidency of the society was passed over virtually. Immediate past president Kim Hodgson (Springfield, USA) handed over the prestigious title to Ronald Dalman (Palo Alto, USA), who will serve as SVS president for 2020–2021.

Dalman noted the ongoing pandemic’s “unprecedented challenges” not only on the meeting itself, but also

Ian Loftus:

NICE abdominal aortic guidelines

Page 14

Hence Verhagen:

Profile

Page 18

SVS Crawford Forum sets stage for future of vascular surgery The E Stanley Crawford Critical Issues Forum, which took place on the first day of SVS ONLINE, charted the course of vascular surgery going forward. This year, it was devised by newly installed president Ronald Dalman.

the Society as a whole. He thanked Hodgson for his “leadership under really trying circumstances.”

Despite moving online, the meeting featured many of its traditional elements, including the annual Crawford Forum (see page 8) that focused on the future of vascular surgery.

Looking to the future

The vascular calendar is set to remain virtual for the remainder of 2020, with the inaugural CX Aortic Vienna meeting set to take place online from 8 to 11 September and the European Society for Vascular Surgery (ESVS) annual meeting taking the form of ESVS Month this year, from 29 September to 29 October. In 2021, a number of in-person meetings have been scheduled, notably the Leipzig Interventional Course (LINC) on 26–29 January in Leipzig, Germany, and the VEITHsymposium, which usually takes place in November, on 23–27 February in New York, USA.

AS IS CUSTOM, the at-that-point SVS presidentelect Dalman had been charged with devising the coveted E Stanley Crawford Critical Issues Forum.

This year, it took place during SVS ONLINE. It was part of the virtual conference’s opening day, 20 June, a pivotal session aimed at guiding the vascular specialty into the future.

Dalman took the approach of returning the forum to its baseline, as former SVS president Crawford envisaged: charting the course of vascular surgery going forward.

Dalman’s forum considered the direction in which vascular surgery is headed and centred around two key questions: What is vascular surgery and what is its future within the US healthcare system?

Joseph Mills, professor and chief at Baylor College of Medicine in Houston, USA, highlighted the work being carried out to establish vascular surgery as a respected part of the medical firmament, setting the stage for the overarching theme of this year’s iteration of the forum.

“I want to create a vision for our members, I Continued on page 4

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SVS Crawford Forum

SVS Crawford Forum sets stage for future of vascular surgery Continued from page 1

want to be able to position the SVS as leaders in this space,” he said. “Ultimately, we want to promote better outcomes in management of vascular care and vascular health for our patients.”

“We hold ourselves to be comprehensive vascular leaders and partners, and many of us have built practices based on this,” Mills said. “But, in many instances, we are viewed as highly technical surgeons who are relied upon for episodic interventions.

“So, to brand ourselves properly we have to do what we say we do, which is to provide comprehensive and longitudinal care.”

Next to speak was Richard Powell of DartmouthHitchcock Medical Center in Lebanon, USA, who carried on the theme of the forum with a talk on how the vascular specialty is valued within the US healthcare system. Vascular surgeons are critical to the safe functioning of an operating room environment, he told the SVS ONLINE audience. “How does the hospital administrator view vascular surgery?” was the core question posed by Powell.

“Our patients tend to be complicated. The average hospital administrator frequently has no idea what vascular surgeons do. I was surprised that this was the case. I have been on the Board of Trustees with Dartmouth for over 10 years and knew all the C-suite executives quite well.

“When I asked our own chief strategy officer, chief financial officer, and chief clinical officer and others what we do, they did not appreciate how frequently we help other services with both elective and, more importantly, with emergent surgical assists.”

Vascular surgeon burnout “a critical issue”

The backdrop of much of this reality in which vascular surgeons operate is the spectre of burnout. The SVS Wellness Task Force was set up to ameliorate and investigate what ails vascular specialists. The very genesis of the group came in response to data suggesting vascular surgeons were at higher risk than other specialties to burnout, said Dawn M Coleman, co-chair of the Wellness Task Force.

“This was considered a critical issue in the face of a threatened workforce. We have approached proactively this uncomfortable space to destigmatise a culture of complacent suffering, specifically to optimise our recruitment and retention.”

Coleman, associate professor, surgery, at the

University of Michigan in Ann Arbor, USA, made the link between reduced productivity and burnout, leading to the sort of lowered revenue incurred by hospitals and decreased quality of care suffered by patients that medicine seeks to avoid.

This led to the session’s final speaker: Ben Harder, managing editor and chief of health analysis of US News & World Report, publisher of respected national healthcare rankings that sorts out the best of American hospitals.

Vascular surgery is not listed as a distinct specialism in the platform’s analysis of the US healthcare system, a situation Dalman would like to remedy. But Harder outlined why vascular surgery as a distinct listing will not be forthcoming.

“Going back to 1990, we identified about a dozen different areas of complex specialty care to evaluate hospitals,” he said. “It has never been our mission to evaluate each department or each service of a broad healthcare organisation separately.

We want to promote better outcomes in management of vascular care and vascular health for our patients.”

“So, I want to be clear that the cardiovascular rankings that we publish evaluates care that is provided by medical cardiologists, interventional cardiologists, and by vascular surgeons as well as cardiothoracic surgeons. All of that is encompassed in that one specialty that we rank and publish. The reason for that is these disparate specialties and services provide care for overlapping patients.”

But Dalman was not finished. He pressed further: “Vascular surgery works with a lot of other specialties, and if we quantify our contributions only in the framework of cardiovascular service line, that is missing a significant contribution vascular surgeons make to health systems and patient outcomes. So, how do we more broadly capture what vascular surgeons bring to a health system?”

Harder demurred, again explaining that US News & World Report does not deviate from its core ranking parameters.

Finally, Dalman asked Harder whether participation in registries such as the Vascular Quality Initiative (VQI) was a ranking criterion, to which the answer was negative. Not to be deterred, the new SVS president pushed further. “I would encourage you to use the VQI for that purpose,” Dalman added.

News in brief

The latest stories from the vascular world

n PCR E-COURSE 2020 PODIUM 1ST: A sirolimus-eluting balloon has been shown to be effective and safe for the treatment of vasculogenic erectile dysfunction in a first-inman study presented at the Giuseppe PCR e-Course 2020 (25–27 Sangiorgi June). Giuseppe Sangiorgi (Novara, Italy) outlined the findings of the SUASION (Sirolimus-eluting balloon utilisation for treatment of vasculogenic erectile dysfunction) study.

For more on this story go to page 8.

n BALLOON-EXPANDABLE COVERED STENTS FOR TREATMENT OF ARTERIAL EMERGENCIES: Maria Antonella Ruffino (Turin, Italy) tells Vascular News about her team’s growing clinical experience with covered stents Maria Antonella as a platform that offers a Ruffino minimally invasive solution for arterial emergencies. Ruffino gives an insight into the advantage of covered stents in such cases, their potential limitations, and which stents may be a favourable option for emergency treatment.

For more on this story go to page 20.

n VIVA HOSTS LATEBREAKING CLINICAL TRIAL LIVESTREAM: In keeping with the trend towards digital education necessitated by the ongoing COVID-19 pandemic, Vascular Interventional Advances (VIVA) Physicians recently hosted a late-breaking clinical trial livestream, showcasing data on the Luminor drug-coated balloon (DCB; iVascular), Tack endovascular system (Intact Vascular), Eluvia drug-eluting stent system (Boston Scientific), Stellarex DCB (Philips), and Medicare Advantage insurance data on the safety of paclitaxel-coated peripheral devices.

For more on this story go to page 32.

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July 2020 | Issue 86

Fibre optic visualisation dissection patients, and the importance of a tailored approach to fragile aortas also emerged in the discussion. The session was chaired by Gustavo Oderich (Rochester, USA) and moderated by Roberto Chiesa (Milan, Italy).

CX 2020 LIVE audience delivers resounding vote in favour of fibre optic visualisation For the CX 2020 LIVE Aortic Podium 1st Session, 489 participants from 62 countries tuned in to hear a series of experts examine technological and procedural developments in the field.

Among topics covered was the early, yet promising, clinical experience with fibre optic imaging technology in complex aortic interventions—identified as the future by 84% of the audience. The benefit of multidisciplinary teams in aortic treatment, the role of aortic wrapping for type A

TILO KÖLBEL (Hamburg, Germany) opened with a presentation on the early clinical experience with Fibre Optic RealShape (FORS) technology (Philips) in complex aortic repair.

Although aortic interventions have developed “rapidly” from simple tubular stent grafts to fenestrated and branched devices using computed tomography (CT) for guidance, said Kölbel, “the hazard from radiation persists,” both for operators and for patients. He told the CX 2020 LIVE audience that FORS technology was developed using a laser fibre in catheters and wires to give a full 3D visualisation of materials without using radiation.

Kölbel detailed that the Hamburg team have used FORS in around 20 patients so far, and while the technology is still in its infancy, it represents a “revolutionary new tool on the horizon, which allows reliable 3D navigation […], has a high potential for reduction of radiation, improves workflow, and gives the operator more information about device position”.

Chiesa opened the discussion following Kölbel’s presentation, asking whether fibre optic technology could be a useful tool in dissection. Kölbel responded that the technology has not yet been applied in a very complex dissection case but noted that it could be a “very attractive” application.

Responding to a question from Egypt, Kölbel affirmed this technique can be used in peripheral arterial angioplasty and predicted a move into other areas, such as interventional neurology and cardiology.

Polling revealed that 84% of the audience believe fibre optic technology is the way forward in complex aortic repair.”

New strategy for fragile aortas

Aortic wrapping technique highlights benefit of multidisciplinary approach THE VALUE OF MULTIDISCIPLINARY working across vascular and cardiothoracic specialties was underscored by Stéphan Haulon (Paris, France), who detailed his experience of off-pump wrapping of the ascending aorta as a treatment option for acute type A dissections. The procedure is offered to frail patients, especially those over the age of 70 for whom in-hospital mortality is “significantly” higher.

The technique involves separating the ascending aorta from the pulmonary artery trunk and the right pulmonary artery, with a tailored Teflon plaque then placed around the aorta from the coronary ostia up to the innominate artery.

Haulon was initially sceptical of the technique, but was subsequently impressed when he investigated the outcomes. “When I moved to Paris, I really questioned the outcomes of this technique and I asked my new cardiothoracic surgeon colleagues if I could look at the 30-day mortality [and] survival rate during follow-up, and also evaluate aortic remodelling. They were happy to show the database up to a 10-year period,” he said.

Haulon presented data from 35 patients treated with aortic wrapping, with a mean age of 77 years, of whom seven had major complications and 11 required reinterventions. Three patients died in hospital within 30 days. Upon follow-up, which was at around 36 months on average, three patients required reintervention for aneurysm evolution and one patient died from dissection-related complication. The estimated survival rate at 12 months was 85%, Haulon told the CX 2020 LIVE audience, and 82% at 24 and 36 months.

Considering these results, Haulon commented that

Kölbel also stressed that currently this technology only reduces radiation from fluoroscopy.

“We still do digital subtraction angiography [DSA] runs and at the end of the procedure we would do a normal final angiograph using contrast and normal radiation, so we cannot reduce that yet”. However, he highlighted: “The big advantage is that we may be able to do the procedure even faster than before and our patients will benefit from that”.

Finally, Oderich asked how soon FORS could be miniaturised to stents and a wider range of wires and catheters. “This is a very early release of the technology,” Kölbel emphasised. “Although it is CE marked, we only have the choice of two catheters and one wire, so it is not able to visualise implants and endovascular aneurysm repair (EVAR) devices, for instance.” He revealed that any updates were some time away.

Polling at the end of Kölbel’s talk revealed that 84% of the audience believe fibre optic technology is the way forward in complex aortic repair.

“That is a call for new technology and for further investment into development of smarter imaging,” Kölbel concluded. “When it comes to imaging, there have been a lot of improvements, but basically, we are working with Stone Age technology.

I am really optimistic that we will see some modern ways of visualising materials inside the body very soon”.

Clockwise from top left: Roger Greenhalgh, Gustavo Oderich, Roberto Chiesa, and Stéphan Haulon off-pump aortic wrapping is associated with favourable early outcomes and a low rate of aortic events during follow–up; he said that the technique should be considered for patients at high risk for conventional surgical repair. “It could be considered [as] a first step before ascending or arch endografting,” he concluded.

In the discussion, moderator Chiesa described aortic wrapping as a “brave” approach. Other topics included the indications for aortic wrapping, prevention of the proximal extension of the dissection, and proximal wrapping of the root.

On indications for aortic wrapping, Haulon commented that there was a “huge selection bias in the series,” as a lot of patients are not suitable for such a repair. He said: “We have treated a couple of chronic type A dissections, but we have also learned from that experience on acute type A [dissections], that we can create a sealing zone for an arch endovascular repair. Now when we do a hybrid repair of the arch, or when we want to perform an arch branch repair and we have no proximal sealing zone, we are now very happy to use this technique because we are confident about the long-term outcomes.”

FABIO VERZINI (TURIN, ITALY) looked at a novel approach for the treatment of fragile aortas using the Valiant Navion thoracic stent graft (Medtronic). “Aortic fragility, especially in acute dissection and intramural haematoma, puts patients at a higher risk for adverse aortic events. Other patients may have increased inflammatory states or elevated aortic wall stress, or challenging anatomies that further impact the thoracic endovascular aortic repair (TEVAR) procedure. There is a clear need to have endovascular devices with specific features to treat fragile aortas.”

Verzini added: “The Medtronic Navion device with Covered Seal proximal configuration allows for decreased vessel trauma thanks to its fully covered proximal edge. Moreover, the proximal edge of the covered seal flares and perfectly accommodates the inner curvature of the thoracic aorta. The accurate deployment system reduces manipulation and movements, and the enhanced graft design provides increased flexibility and conformability.”

In response to a question from Oderich about whether fragile aorta consisted of acute aortic syndrome alone or whether it should include connective tissue disorders, Verzini indicated that, based on his own experience, the definition could be broadened to encompass patients “with a thrombosed neck, as well as those who may have a genetically triggered disease and some female patients, especially if they present with arteritis or an inflammatory disease. These are the patients more at risk of developing complications, and I tend to think of them as having fragile aorta more and more”.

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PCR e-Course coverage

PCR e-Course 2020: Sirolimus-eluting balloon “a valid treatment option” for vasculogenic erectile dysfunction A sirolimus-eluting balloon has been shown to be effective and safe for the treatment of vasculogenic erectile dysfunction (ED) in a first-in-man study presented at the PCR e-Course 2020 (25–27 June). Giuseppe Sangiorgi (Clinica San Gaudienzio, Novara, Italy) outlined the findings from the SUASION (Sirolimus-eluting balloon utilisation for treatment of vasculogenic erectile dysfunction) study.

H

e said: “Interventional treatment with approval, and, said Sangiorgi, that “is a sirolimus-eluting balloon may be dedicated to this indication”. Patients considered as a strategic approach were those affected by ED who had to patients affected by vasculogenic erectile not responded to phosphodiesterase-5 dysfunction who are non-responding to current inhibitors (PDEF-5i) for at least one year, first-line oral phosphodiesterase-5 inhibitors.” and who presented with an international More than 300 million men worldwide have index of erectile function-5 (IEF-5) score ED, with 52% of men in Europe between ≤12, and a dynamic Doppler with Caverjet the ages of 40 and 70 years reporting some injection with peak systolic velocity degree of ED. For patients with coronary artery Giuseppe Sangiorgi (PSV) ≤20cm/second. disease and/or diabetes, this increases to 67%, The efficacy endpoint in the trial is a Sangiorgi explained, adding that successful treatment composite of Delta International Index of IEF-5 ≥5 and has a strong impact on quality of life.

Delta Doppler PSV velocity >5cm/second, at six-month SUASION is a prospective, postmarket, nonfollow-up. The safety endpoint is freedom from target randomised, all-comers, multicentre, single-arm study lesion revascularisation (TLR) at eight-month follow-up. of a new sirolimus drug-eluting balloon (Magic Touch, Sangiorgi said: “So far, we have enrolled 27 patients, Concept Medical) that recently received CE mark with a mean age of 60 years. This is a very common

Global SYMPLICITY Registry shows renal denervation lowered blood pressure in patients with hypertension out to three years Medtronic has reported new data from the Global SYMPLICITY Registry (GSR), which showed that renal denervation (RDN) with the Medtronic Symplicity renal denervation system significantly reduced blood pressure (BP) in uncontrolled hypertension patients out to three years independent of anti-hypertension medication burden. The data were presented virtually as part of the PCR e-Course 2020.

THE STUDY SHOWED RDN LED to significant and clinically meaningful reductions in BP that were sustained out to three years post-procedure (17 mmHg OSBP [office systolic blood pressure]), with more patients achieving BP below 140 mmHg, while those at very high BP levels experiencing drops into lower risk BP ranges. The number of patients at the very highest BP level—greater than 180 mmHg systolic at baseline—dropped by two-thirds at three years.

Additionally, the number of patients who had reported office systolic BP less than 140 mmHg—a more controlled level of BP—increased from 13% at baseline to 39% at three years. The BP drops occurred while patients were prescribed an average of four or

more antihypertensive medications, which remained unchanged over three years. The absence of increase in medications suggest that RDN’s effect was independent of anti-hypertensive medication burden. RDN continued to show a strong safety profile at three years with an incidence of renal artery stenosis of 0.3%, which is within the expected range for patients with hypertension not undergoing denervation.

“In the largest real-world study of patients receiving renal denervation, we are seeing significant and clinically meaningful reductions in both office and 24-hour blood pressure sustained out to three years post-procedure, which demonstrates the durability of RDN,” said Felix Mahfoud, cardiologist at

population that we treat in our cath labs—diabetes mellitus in approximately 30%, and 30% of patients presented with coronary artery disease, and are undergoing therapy for it. The baseline IIEF score was 9.7±6.6 [which is] moderate to severe erectile dysfunction.”

The target lesion was the internal pudendal artery in 90% of patients. Bilateral disease affected 26%. In a minority of cases (14%), a drug-eluting stent was required, due, said Sangiorgi, to “a residual stenosis of less than 30%, or a flow limiting dissection”. Procedural success was 100%. Treatment success was measured by the minimum clinically relevant improvement in the IIEF-5 score and in Dynamic Doppler PSV between baseline and six-month follow-up. Sangiorgi reported that more than 74% had an improvement of >5 in the IIEF-5 score, and 73% had a Doppler PSV score

Of the 27 patients who reached sixmonth follow-up, 69% had improved their IEF-5 score and Doppler PSV compared to baseline.” increase of >10. At six months, this was 70.4% and 68.4%, respectively.

Summarising, he said: “Erectile dysfunction shares modifiable major cardiovascular risk factors with coronary artery disease and peripheral artery disease.

The vast majority of patients with erectile dysfunction presented with an arterial stenosis affecting the iliacpudendal-penile arteries. [...] “Percutaneous treatment with a sirolimus-eluting balloon may become the second line of therapy for patients with erectile dysfunction.”

Saarland University Medical Center in Homburg, Germany, who presented the data during the meeting. “These data reinforce that RDN is a viable, complementary option with positive effects on hypertensive patients without requiring an increase in medication burden over time.”

The Global SYMPLICITY Registry is the largest study documenting the long-term safety and effectiveness of the Medtronic renal denervation systems in a real-world setting in patients with uncontrolled hypertension. To date, the registry has enrolled more than 2,860 patients treated with RDN and includes three-year follow-up for more than 2,500 patients. The data presented at PCR closely mirror a recent manuscript of GSR data published in the Journal of the American College of Cardiology, which reported that RDN showed

To date, the registry has enrolled more than 2,860 patients treated with RDN and includes threeyear follow-up for more than 2,500 patients.”

lasting results in a variety of high-risk patients, including those with diabetes, chronic kidney disease (CKD), isolated systolic hypertension (ISH), or resistant hypertension.

“Following the positive SPYRAL HTN-OFF MED Pivotal data presented at the American College of Cardiology annual meeting, these new data provide additional evidence on the safety and efficacy of renal denervation to help manage uncontrolled hypertension, with study patients experiencing meaningful blood pressure reductions out to several years,” said Dave Moeller, vice president and general manager of the Coronary and Renal Denervation business, which is part of the Cardiac and Vascular Group at Medtronic. “As the body of clinical evidence supporting renal denervation grows, we are encouraged by the outcomes observed in both controlled clinical trials and real-world practice.”

In addition to the Global SYMPLICITY Registry, the Medtronic SPYRAL HTN Global Clinical Program includes the SPYRAL HTN-OFF MED PIVOTAL and SPYRAL HTN-ON MED Trials, both prospectively powered, randomised, sham-controlled studies evaluating patients with uncontrolled blood pressure in the absence and presence of prescribed anti-hypertensive medications respectively. Approved for commercial use in more than 50 countries around the world, the Symplicity Spyral system is limited to investigational use in the USA.

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Aortic arch advances

CX 2020 LIVE aortic arch discussion highlights importance of underlying pathology and benefit of multidisciplinary team

Through presentations, discussion, and polling, the CX 2020 LIVE Aortic Arch Consensus session—chaired by Roger Greenhalgh (London, UK) and moderated

by Stéphan Haulon (Paris, France)—aimed to tackle some vital questions, including how to reduce the risk of stroke in thoracic aortic endovascular procedures, what the best options are for the left subclavian

Silent cerebral lesions study: Clinical stroke incidence small but infarction rate “substantial” on magnetic resonance PHILIPPE CHARBONNEAU (PARIS, FRANCE) presented findings from a multicentre study which looked to quantify silent cerebral lesions, evaluate their clinical impact and to identify predictive factors following endovascular arch repair. He noted that TEVAR is the primary repair technique for aneurysms of the descending thoracic aorta but added that “neurological complications from this technique remain a significant concern” with the stroke rate at around 5%.

The study found that a total of 245 silent cerebral infarcts were detected in 45 patients, which represented almost 50% of the cohort.

Lesions were multiple in 78% with a “predilection for both hemispheres” (58%) as opposed to isolated hemispheres (33% left and 9% right). An operative analysis of patients with and without new lesions showed that urgent procedure, deployment in Ishimaru zone 0–1, placement of a branch or fenestrated endograft, a proximal stent diameter of more than 40mm and the use of a haemodynamic strategy during the deployment were all “significantly associated with the presence of ischaemic lesions”. Greenhalgh remarked that “The STEP study was set up for this very reason.

He concluded: “The key is to see whether we can modify technique to reduce [the infarction rate].”

branch, and how best to approach aortic arch aneurysms. The session covered atherosclerosis, dissection, transection and ulcers, and their role in guiding treatment was clearly emphasised, with audience polling revealing that 85% would alter reconstruction in the arch according to the underlying pathology. The session also dealt with the wider debate of open versus endovascular surgery and considered the benefits of a multidisciplinary team. In a boost for the endovascular approach in this difficulty anatomy, 63% of audience members disagreed with the statement “Open is best”.

GUSTAVO ODERICH (Rochester, USA) outlined preliminary experience with a range of device options that would enable the left subclavian artery [LSA] to stay patent. He began with the statistic that “30–60% of thoracic endovascular aortic repair [TEVAR] patients require Zone 2 incorporation with coverage of the LSA”. Considering the implications, he detailed: “We know LSA coverage without revascularisation is associated with more arm ischaemia, posterior circulation events, and spinal cord injury”.

He noted that patient-specific fenestrated stent grafts have been available for over two decades, and added that reports from the Cleveland Clinic and the Hamburg group demonstrate that mortality and stroke can be an issue, particularly if there is misalignment of the stent graft requiring arch manipulations.

He concluded: “Zone 2 extension is needed in up to 60% of TEVAR patients, and the preliminary

Polling revealed that 85% of the audience would alter reconstruction in the arch according to the underlying pathology.”

experience with LSA branch devices indicates low morbidity and stroke rates, with high patency rates”.

In the discussion following his presentation, Oderich first addressed a question from Haulon on treatment with an off-the-shelf device. He responded: “We can have an off-the-shelf device for the subclavian artery, because the location of the left subclavian artery in relation to the left carotid artery is quite predictable”.

He continued: “I do think that a lot of these patients currently being treated with coverage will actually have the option of revascularisation.

That would include acute cases, like dissection or even transection. In the pivotal trial from Gore, the enrolment has been quite fast for the chronic dissection group. It is quite impressive. They were tentatively trying to enrol 10 patients and they have already included 93. So, I think that there will be a large subset of patients that will benefit from the left subclavian branch”.

An audience member watching from Moldova then asked Oderich, “In what subgroup of patients would either a bypass or transposition be used rather than a branch endograft?” to which Oderich responded that the “obvious” cases would be when the subclavian artery is not suitable for a branch.

Oderich noted that, given the investigational nature of some grafts, surgeons are still “shying away” from treating patients with certain indications, for example a very dominant vertebral artery. That being said, “with increased experience, as we showed, the patency rate is excellent”.

Finally, a question from Singapore asked when you would choose an LSA branch device over a fenestrated one for the LSA. “The issues with fenestration are several-fold,” Oderich responded.

“First of all, from the standpoint of industry, it becomes [a] totally patient-specific device for the most part. The nice think about the branches is the ability to deploy the aortic stent graft and commit to that position. You do not have to keep twisting and you can just focus on the branch. “I would say people are probably going to move away from fenestration towards a branch,” he concluded.

Collaboration needed to respond to aortic arch aneurysms ROBERTO CHIESA (MILAN, ITALY) provided a comprehensive overview of total endovascular, hybrid, open and frozen elephant trunk repair techniques, looking at which is the best strategy to use in different scenarios, and the European Society for Vascular Surgery (ESVS) recommendations for each. He stressed: “The clever surgeon chooses the best option for the patient.”

Chiesa’s key message on aortic arch aneurysms was the need for multidisciplinary decision-making. He revealed that, at his centre, meetings take place every day between vascular and cardiac surgeons to decide on the choice of technique. Chiesa’s message also illustrated the potential that exists for using patient characteristics to choose between endovascular and open reconstruction. This view was reflected in the polling result on whether to alter reconstruction in the arch according to underlying pathology, with which 85% of respondents agreed. “It [the approach chosen] depends on the extent of the disease and the situation of the patient. In a fit patient, also in a young patient … open surgery can represent a good option.

Endovascular repair offers possibilities that open surgery cannot offer,” he said.

“Acceptable results in fit patients” can also be achieved using the Frozen Elephant Trunk technique, said Chiesa, describing a hybrid strategy—a combination of both open and endovascular technique—as “a good option in high to moderate-

risk patients”, and total endovascular branch repair as providing improving results in anatomically suitable patients. He closed his presentation with the prediction: “I think that will represent the future.”

Chiesa’s colleague, Luca Bertoglio (Milan, Italy), presented an edited case of a carotid subclavian bypass. He explained that LSA revascularisation is recommended in aortic procedures to reduce the incidence of spinal cord ischaemia and stroke.

Bertoglio noted that “we prefer to revascularise the LSA in our centre”.

Aortic Vienna Register at cxsymposium.com/cxaortic for the inaugural CX Aortic Vienna Live Virtual Conference (8–11 September 2020), with a programme focused on cardiovascular aortic advances and classical open and endovascular solutions.

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Endoleak management

Nearly 70% of CX 2020 LIVE global aortic audience finds type II endoleak without sac expansion harmless

In this session, presentations, polling, and live discussion enticed nearly 1,000 participants to join live from 75 countries, including the UK, Brazil, USA, Mexico, Italy, Spain, Saudi Arabia, Egypt, Germany, and Argentina—to name the top 10—all keen to ask questions of the experts in the search of consensus on endoleak management.

After hearing presentations from leading specialists who recognised that sac expansion is a key indicator for intervention in type II endoleaks, 68% of the CX LIVE audience voted that they regard type II endoleak without sac expansion as harmless.

ROGER GREENHALGH (London, UK), chair, was joined by past president of the Vascular Society of Great Britain and Ireland (VSGBI), Ian Loftus (London, UK) as moderator. A significant talking point to emerge from the session was the fact that an expanding sac after endovascular aneurysm repair (EVAR) meant the physician had a job to do—to find the endoleak and put it right. In addition, the audience heard early experience of the use of contrast-enhanced ultrasound, which may help identify persistent endoleak after embolisation.

Questions came in thick and fast from the global CX aortic vascular community, from Kuala Lumpur in Malaysia, to São Paulo in Brazil, and Hamburg in Germany, for leading interventional radiologist Lindsay Machan (Vancouver, Canada), who presented on the treatment of type II endoleaks, and surgeon and CX Aortic Executive Board member Gustavo Oderich (Rochester, USA), who highlighted the potential advantage of using contrast-enhanced ultrasound to assess endoleak treatment success intraoperatively.

“Lack of agreement” on indications for type II endoleak treatment

Machan began by acknowledging the “continuing controversy” over whether type II endoleaks should even be treated, quoting a commentary by Thomas Forbes (Toronto, Canada), published in the Journal of Vascular Surgery in early 2020, in which the author professed to be “struck by how little progress we have made in our understanding of the pathophysiologic mechanism, significance, and treatment of type II endoleak”.

Machan said: “There is currently a lack of agreement on the indications for treatment of type II endoleaks, but an increase in sac size up to, or more than 10mm per year is generally accepted [as reason to intervene].

With specific reference to embolisation as a treatment option, there is no ‘best’ embolic agent, but a patientspecific approach is needed.”

He noted that guidelines from both the Society for Vascular Surgery (SVS) and European Society for Vascular Surgery (ESVS) recommend that conservative management is appropriate in isolated endoleaks without sac expansion, but stipulate that with an increasing sac size of 10mm or greater compared to pre-EVAR, treatment should be considered. “A relative indication is expansion of sac size over 5mm over any

Contrast-enhanced ultrasound may help identify persistent endoleak after embolisation ODERICH DETAILED THE USE of contrastenhanced ultrasound for intraoperative assessment and as an effective means of finding the precise location of a type II endoleak. Beginning his presentation, Oderich acknowledged that endoleak diagnosis can be difficult using angiography alone. Sharing his views, which clearly resonated with the online audience, he noted that although a conservative approach towards type II endoleaks has been recommended, when treatment is indicated, clinical success averages 50% to 60%.

Oderich explained that his centre employs both transarterial and translumbar approaches to treat endoleaks, depending on the type of endoleak and whether the inferior mesenteric artery is patent.

The use of intraoperative contrast-enhanced ultrasound is universal, Oderich said, to determine

six-month period,” he said.

The goal of treatment when opting to treat type II endoleaks is access to the nidus, Machan explained, and occlusion of that central communication and the feeding and draining branches.

He detailed that there are “multiple” possible access routes, including transarterial, translumbar, perigraft, transgraft, transvenous, as well as laparoscopic and open repairs.

Machan offered examples of each of these approaches but commented that the most commonly used route “still is transarterial embolisation”.

Looking at long-term outcomes, Machan highlighted a review from Cleveland Clinic, Cleveland, USA, looking at 140 procedures in 95 patients, with a mean follow-up of just over two years, and using a variety of embolic materials and approaches.

The paper, Machan said, described a five-year cumulative survival of 65%, freedom from explant in 89%, and secondary embolisation in 76% of patients.

There was, however, sac expansion of more than 5mm seen in nearly half of the patients (44%) at mean twoyear follow-up.

Intraoperative contrast-enhanced ultrasound may help identify persistent endoleak after embolisation.”

Machan’s presentation prompted Greenhalgh to ask during the following panel discussion whether type II endoleak should be considered “unimportant” unless there is sac expansion, and what level of sac increase is important to act upon.

Reflecting the lack of clarity over the issue, Machan responded: “I do not pretend to have the answer to those questions. That invited commentary by Thomas Forbes resonated very well with me.

“We continue in our multidisciplinary rounds to struggle with what to do with type II endoleaks—we use increasing sac size as our primary indication [to intervene].”

Duplex ultrasound a good alternative to CT

Polling revealed 60% of the audience regard type II endoleak without sac expansion harmless

if the endoleak is completely gone, or if there is a persistent endoleak that warrants additional intervention.

In his concluding remarks, Oderich commented that intraoperative contrast-enhanced ultrasound may help identify persistent endoleak after embolisation, and that additional treatment of persistent endoleak may help minimise the risk of a failed reintervention.

However, he surmised that larger clinical experience and longer follow-up is needed to advance the field.

MAARIT VENERMO (Helsinki, Finland) detailed her team’s experience since 2011 with ultrasound surveillance after EVAR. “We have found it feasible,” she told the CX 2020 LIVE audience.

Venermo and colleagues reviewed consecutive patients who underwent EVAR for intact infrarenal abdominal aortic aneurysms (AAA) between 2000 and 2016. Patients were divided into two groups, depending on whether they followed a CT-based (group A) or ultrasound-based (group B) postoperative imaging protocol. Group A included 168 patients, while B had 301 patients, with patients followed up for an average of 5.6 and 3.6 years, respectively.

Venermo concluded: “In our study, ultrasound surveillance was not inferior to CT surveillance. The total number of CT scans was lower in group B, even though 40% of patients in the ultrasound surveillance group had additional CT.” She continued: “Surprisingly, many patients—about a third—underwent CT scans for reasons other than an aneurysm.”

Finally, Venermo added that the data also point to the cost-effective nature of ultrasound surveillance: “Over 10 years, the cost of ultrasound protocol is 57% less expensive than annual CT protocol, despite the single extra CTs conducted on a relatively high proportion of the patients”.

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July 2020 | Issue 86

Guidelines

Nice AAA guidelines

NICE aortic guidelines recommend discussion between physician and patient before offering any treatment The UK National Institute for Health and Care Excellence (NICE) has published guidelines on abdominal aortic aneurysm (AAA) diagnosis and management. Discussion between physicians and patients to consider the risks of any intervention versus no intervention is encouraged, and, while the guidelines are in favour of open repair for most patients, they also highlight circumstances in which open repair is contraindicated because of structural or anaesthetic medical comorbidities.

W

hen the draft guidelines were published in May 2018—which recommended that UK healthcare professionals should favour open repair over endovascular repair for unruptured aneurysms—they cast a shadow over EVAR and have since been the source of debate and controversy among the vascular community, which has been exacerbated by multiple publication delays.

These final recommendations indicate that NICE has listened to the physician community’s concerns to recognise that EVAR is sometimes the only option in certain patients. The new guidance places the onus upon the physician to discuss all the management options for unruptured aneurysms with the patient—conservative management, open surgical repair, and EVAR. It is also notable that there is a recommendation for following patients in the National Vascular Registry to learn Ian Loftus more about results.

Furthermore, the guidelines now emphasis that the physician is responsible for discussing the known shortcomings of EVAR with the patient. EVAR has operative mortality and early mortality benefit for patients over open repair, but has been found in trials to have inadequate return for follow-up. This meant that failing EVARs with endoleak and secondary rupture were not picked up with consequent unacceptably high AAA-related mortality; a finding that became more marked after eight years of follow-up.

Recommendations in focus

In the new section on elective repair of unruptured aneurysms (1.5), the NICE board states in recommendation 1.5.1 that repair for patients with an unruptured AAA should be considered if it is symptomatic, asymptomatic, larger than 4cm and has grown by more than 1cm in one year (measured innerto-inner maximum anterior-posterior aortic diameter on ultrasound), or asymptomatic and 5.5cm or more, but measured inner-to-inner. The guidelines here rely on the UK Small Aneurysm Trial (UK SAT) and ADAM trial that identified one of the criteria for intervention as growth of more than 1cm per year. Notably, however, they also use a 5.5cm inner-to-inner measurement in the recommendation. In the UK SAT, a smaller measurement was used—5.5cm outer-to-outer.

Recommendation 1.5.2 focuses on discussing the benefits and risks of repair or conservative management.

It states: “When discussing aneurysm repair with patients who have an unruptured AAA, explain the overall balance of benefits and risks with repair and with conservative management, based on their current health and their expected future health. The decision on whether repair is preferred over conservative management should be made jointly by the patient and their clinician after assessment of a number of factors”.

These include aneurysm size and morphology, the patient’s age, life expectancy, fitness for surgery, and other conditions they have, the risk of AAA rupture if they do not have repair, the short- and long-term benefits

survival or long-term outcome, when compared with open surgical repair, have been discussed. Secondly, only consider complex EVAR if it will be performed with special arrangements for consent and for audit and research that will determine the clinical and cost effectiveness of complex EVAR when compared with open surgical repair, and all patients are entered onto the National Vascular Registry.

Comment

Ian Loftus, consultant vascular surgeon at St George’s University Hospital NHS Foundation Trust (London, UK) and past president of the Vascular Society of Great Britain and Ireland (Vascular Society), spoke to Vascular News about the newly-published guidelines. and risks, and other disadvantages of repair, and the He commented: “This has clearly been a very difficult uncertainties around estimates of risk for AAAs larger process for NICE and for the professions involved as than 5.5cm, again measured inner-to-inner. stakeholders. It would have been without precedent Recommendations 1.5.3 to 1.5.5 consider open to see a recommendation to completely stop such an surgical repair, standard EVAR, or conservative established therapy as endovascular aneurysm repair. management. The guidelines suggest healthcare The final version of the guidelines recognises the professionals offer open surgical repair for patients difficulties faced when a clinician sits with the individual patient, and the need for patient and clinician choice. It allows the flexibility to still proceed with endovascular repair in circumstances where that is felt to be an appropriate course of action.” Loftus added: “This should be seen, however, as a wake-up call to endovascular practitioners and industry. We need to ensure that endovascular therapies are performed in appropriate patients, in an appropriate environment. Most importantly, we must work together to Sophie Renton Michael Jenkins ensure long term durability of aneurysm repair. The collection of robust outcomes with unruptured AAAs “meeting the criteria in data, through the National Vascular Registry, is a vital recommendation 1.5.1, unless it is contraindicated part of the final guidelines.” because of their abdominal copathology, anaesthetic Sophie Renton, consultant vascular surgeon at risks, and/or medical comorbidities” (1.5.3), “who meet London North West University Healthcare NHS Trust the criteria in recommendation 1.5.1 and who have an (London, UK) and secretary to the Vascular Society, also abdominal copathology […] that may make EVAR the remarked on the recommendations: “I am pleased that preferred option” (1.5.4), and “meeting the criteria in the final NICE guidance recognises the importance of recommendation 1.5.1 who have anaesthetic risks and/ patient choice and gives greater autonomy to the doctoror medical comorbidities that would contraindicate open patient relationship. I believe these recommendations surgical repair” (1.5.5). are a pragmatic solution. The Vascular Society will be Finally, recommendations 1.5.6 and 1.5.7 outline working to support implementation of the guidelines and complex EVAR diagnosis and management. If open monitor progress of implementation through the NVR.” surgical repair and complex EVAR are both suitable Michael Jenkins, consultant vascular surgeon at St options (1.5.6), or for patients who have anaesthetic Mary’s Hospital, Imperial College Healthcare NHS risks and/or medical comorbidities that would Foundation Trust (London, UK), commented: “Crucially contraindicate open surgical repair (1.5.7), two factors the final NICE AAA guidance gives back autonomy should be taken into consideration. Firstly, only consider to clinicians and takes into account patient choice and EVAR if the risks of complex EVAR compared with shared decision making on an individual patient basis. It the risks of open surgical repair, and the uncertainties continues to acknowledge the better durability of open around whether complex EVAR improves perioperative repair, but now does accept the place of EVAR under certain circumstances including consideration of patient fitness.

“Additionally, the new guidance defines the place of custom devices and the importance of patient information during consent to clarify where we are uncertain regarding long term durability. Closer scrutiny and ongoing surveillance of such device performance over time within the UK National Vascular Registry is vital and will ultimately give us longer term data to decide the future utility of these devices. Although anatomical suitability and use within manufacturer’s ‘instructions for use’ is not stated, it is implied that it will be an important criterion within multidisciplinary team decision making.

“Importantly, allowing ongoing use of EVAR in controlled circumstances will allow us to re-evaluate where grafts perform well to help develop better and more durable devices for the future. It is now up to the vascular community to sensibly adopt and implement these guidelines and accept the important message behind them.”

Issue 86 | July 2020

SVS coverage

“Poor long-term survival” following explantation of an infected endograft Paolo Perini (University Hospital of Parma, Parma, Italy) told the audience of SVS ONLINE (20 June–2 July) that endograft explantation of an infected abdominal aortic endograft is associated with high postoperative mortality and poor long-term survival. Furthermore, there was a high rate of reinfection.

ACCORDING TO PERINI and colleagues, infection of an abdominal aortic endograft is a rare but “devastating complication” that is associated with high mortality. He told the SVS ONLINE audience that the aim of the present study—a multicentre review of endograft explantations performed over a 20-year period (1999–2019)—was to analyse factors “that may have influenced 30-day mortality, 30-day morbidity, and longterm survival”.

The investigators identified 257 patients who had undergone (abdominal aortic) endograft explantation at 11 centres over the study period. Of these, 49 (19%) had an infected endograft. “The mean age of patients was 73 years and there was a clear male preponderance [90% of patients]. This was a high-risk population. In fact, 86% of patients had an American Society of Anesthesiologist (ASA) score higher than 3,” Perini observed.

He added that one finding was that explantation for infection “generally occurred” earlier than explantation for endoleak correction (13 vs. 46 months, respectively; p<0.001).

Furthermore, 35% of patients had previously undergone endovascular correction. This finding did not mean prior endovascular correction was a risk factor for infection because, according to Perini, “explantation for other reasons presented a similar rate of endovascular

correction”. However, any intervention could be a factor in a patient developing an infection. He told Vascular News: “The fact that explantations for infection are performed earlier than explantations for other reasons (13 vs. 46 months) may indicate the infection often occurs during the first year after endovascular aneurysm repair (EVAR). Thus, utmost attention should be paid during this

Infection of an abdominal aortic endograft is a rare but devastating complication that is associated with high mortality.” period, especially in case of invasive manoeuvres (any invasive manoeuvre: cardiac, urologic, dental... ). So even though not demonstrated in the present study, endovascular reinterventions may potentially play a role in the development of ‘late’ endograft infections.”

All patients underwent complete endograft explantation, with 63% subsequently undergoing anatomic reconstruction and 37% undergoing

SVS releases new clinical practice guidelines on visceral artery aneurysms The Society for Vascular Surgery (SVS) has released new clinical practice guidelines on the appropriate care and treatment of aneurysms of the visceral arteries.

T

hese SVS evidence-based practice guidelines offer recommendations to inform the diagnosis, treatment options, screening and follow-up of visceral aneurysms. Evidence-based size thresholds for repair of aneurysms of the renal arteries, splenic artery, coeliac artery, and hepatic artery, among others are included. Open surgical and endovascular repair strategies are described as well as specific circumstances

extra-anatomic reconstruction. While anatomic reconstruction was more common overall, Perini noted that extraanatomic reconstruction was “a common solution for patients operated on in an urgent setting [57% of patients were urgent cases]”.

In terms of the infection itself, 22% of infections were found intraoperatively.

Additionally, the most commonly identified micro-organisms were Gram positive and multiple causative agents were found in two thirds of cases.

“Whenever possible, we started antibiotic therapy preoperatively in agreement with infectious disease specialists.

Postoperatively, targeted antibiotic therapy was continued for at least three weeks,” he explained.

At 30 days, mortality was 25% and this rose to 35% when in-hospital mortality was taken into considerations.

Perini commented: “We did not find any specific risk factors for higher mortality.

The presentation of aortoenteric fistula [40% of cases] was associated with a higher mortality rate but the difference [compared with other presentations] was not statistically significant. Morbidity rates were high, especially in terms of renal injury [27%], respiratory failure [33%], and gastrointestinal complications [18%].”

During long-term follow-up (mean 31.2±47.8 months), there were four aneurysm-related deaths and 20% of patients went on to have another infection. The one-year and five-year survival rates were 57% and 32%, respectively, and these rates were significantly lower than for patients who underwent explantation for another reason (83% and 65%, respectively; p=0.035). One-year survival rates were also significantly lower in patients who underwent extra-anatomic reconstruction than those who underwent anatomical reconstruction:

in which aneurysms may be considered for repair at a smaller size such as in women of childbearing age. False aneurysms are also discussed.

Of all intra-abdominal aneurysms, visceral arteries affect only 5% of cases. Visceral artery aneurysms include both true aneurysms as well as pseudoaneurysms. The clinical significance of visceral artery aneurysms is mainly related to their potential for rupture and, once that happens, the challenges of diagnosis and treatment.

“Nearly one-fourth of visceral artery aneurysms reported have presented with rupture, and the mortality rate of these diagnosed ruptures is at least 10%, probably higher,” said lead author Rabih Chaer. “The mortality following ruptured coeliac artery aneurysms and ruptured splenic artery aneurysms in pregnant women approaches 100%.”

With the increased use of sophisticated forms of intra-abdominal imaging, including magnetic resonance imaging and angiography (MRI, MRA) and computed tomography scans and angiography (CT, CTA), occult visceral artery aneurysms are being diagnosed with increased frequency.

“The detailed imaging studies have allowed for an improved ability among vascular surgeons to identify asymptomatic lesions, and an enhanced potential

15

33.3% vs. 72.2%, respectively; p=0.0014.

Perini noted to Vascular News that while a substantial proportion of patients who underwent extra-anatomic reconstruction were urgent cases (i.e. high-risk), the procedure itself may have contributed to the lower survival rate. “Regarding non-urgent patients who underwent extraanatomic reconstructions, complications were frequent and severe. Aside from a patient who died during the postoperative period, severe complications occurred in four out of five patients: one acute limb ischaemia due to axillobifemoral bypass thrombosis, two had a reinfection, and one developed an aneurysm of the aortic stump,” he explained.

Perini concluded that explantation of an infected endograft was “technically challenging” and was associated with “high postoperative mortality and morbidity rates”. He also noted that longterm survival was “poor”.

Paolo Perini

for preoperative or preprocedural planning and elective treatment of these aneurysms,” Chaer said.

“Improvements in endovascular therapies have also allowed an enhanced ability for treatment of these often anatomically complex lesions with a large variety of individualised and precise catheter-based therapies.”

These clinical practice guidelines provide much needed guidance to vascular surgeons who treat patients with aneurysms of the renal and visceral arteries. The ultimate treatment goal should be to prevent aneurysm expansion and potential rupture by exclusion from the arterial circulation while maintaining necessary distal or collateral bed perfusion.

The mortality following ruptured coeliac artery aneurysms and ruptured splenic artery aneurysms in pregnant women approaches 100%.”

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July 2020 | Issue 86

Juxtarenal aneurysm treatment

CX 2020 LIVE: Surgeonmodified and custom-made endografts carve their place in juxtarenal aneurysm treatment

Tips and tricks for repairing a thoracoabdominal aortic aneurysm using an off-the-shelf device BIJAN MODARAI (LONDON, UK) presented a

case that demonstrated the repair of a large thoracoabdominal aortic aneurysm using an offthe-shelf thoracoabdominal branched device. The Zenith t-Branch (Cook Medical) incorporates four downward-facing outer branches and is designed to be coupled in a modular fashion with proximal and distal components to allow treatment of a variety of aortic anatomies. Modarai noted that “a number of markers on the stent graft facilitate accurate positioning, once it is placed inside the

Clockwise from top left: Roger Greenhalgh, Stéphan Haulon, Gustavo Oderich, Nikolaos Tsilimparis, Bijan Modarai, and Said Abisi

Over a five-week period, CX 2020 LIVE attracted more than 6,000 registrants from over 120 countries. The topic of the 10th and final session was Juxtarenal Aneurysm Consensus. Experts covered cuttingedge developments in the field and tips and tricks for complex procedures. They also examined outcomes with a range of devices on the market. There was lively discussion reviewing surgeon-modified and custom-made fenestrated endografts and strong support for inner branch technology, backed by 79% of participants in the session. Other topics covered included bridging stent grafts, balloon-expandable covered bridging stents, and off-the-shelf solutions for hostile necks. The session was chaired by Stéphan Haulon (Paris, France) and moderated by Gustavo Oderich (Rochester, USA), who cautioned against being a staunch defender of one technique over another, as “everything has a potential role”.

SAID ABISI (LONDON, UK) reported on experience with inner branch technologies and noted that although endovascular aneurysm repair (EVAR) and branched endovascular aneurysm repair (BEVAR) have “good outcomes”, they are limited by “certain anatomical challenges which can make these procedures difficult”.

Fenestrated procedures in particular require “very accurate planning and positioning”, and vessel deformation due to infrarenal angulation and iliac tortuosity may result in “unpredictable outcomes”, he adds. In addition, traditional BEVAR with outer branches “requires enough working lumen for the branches to open out and also requires long aortic coverage and a longer distance for bridging stents”.

The researchers set out to examine a cohort of patients undergoing fenestrated and branched EVAR over the past two years, with a focus on procedural aorta”. He described the techniques adopted, which ultimately led to successful sealing of the aneurysm.

Asked about what the best strategy is for preventing bridging stent failure, Modarai answered that “the mode of failure is multifactorial.

I do not think it is about saying whether it is best to use a balloon-expandable or self-expandable stent. I think it comes down to good quality control”. He went on to explain that this means “adequate sizing; ensuring that those branches are positioned in the optimal way so that the bridging distance is not very long; ensuring that the stent is [far] enough inside the branch so that there is adequate overlap, and to make sure that the stent is not too far into the target vessel”.

In regards to the use of antiplatelet therapy, Modarai stated that because “we do not have level one evidence, I tend to put these patients for at least a year, if not for life, on dual antiplatelet agents in the hope that all of those measures will reduce the chances of a stent occlusion” but commented that a “mistake” that a lot of people make is to compare branches with fenestrations, which he said is “like comparing apples with oranges”.

A further question on the spinal complication rate, which Modarai highlighted was “the most feared complication with these repairs”, and how best to prevent it, led Modarai to remark that the rate of cord complication is “related to the amount of the aorta that is covered”. In terms of prevention, Modarai asserted that “again, I think it is multifactorial; some of the repairs are worth staging”.

Polling showed the majority of the audience like the idea of using inner brances

outcomes and to study the indications for use of inner branches.

Abisi summarised that inner branches “have a good early outcome for the treatment of highly complex aortic aneurysms”, adding that they are “easy to use, adaptable to variable anatomy, and have demonstrable advantages compared to conventional technology”.

However, he noted that longer-term data are needed to determine their wider applicability.

Responding to a question from Oderich regarding patency concerns, Abisi outlined that “this is why we are currently very cautious about selecting only those who are not suitable for standard fenestrated or branched”, and concluded that, as a result, the data need to be monitored, with patients followed-up over the long term.

Hopefully we will have data to support the use of [inner branches] in the near future”

Custom-made and surgeon-modified endografts both have their place NIKOLAOS TSILIMPARIS (MUNICH, GERMANY) offered an insight into the technical success achieved through surgeon-modified fenestrated endografts compared to custom-made fenestrated endografts. His presentation revealed that surgeon-modified endografts have been associated with higher type 3 endoleaks and reintervention, but achieve similar long-term outcomes to the custom-made devices.

However, Tsilimparis noted that to directly measure up the two treatment options side-byside could be seen as an “unfair comparison”, as they are “two different entities”. He highlighted the role physician-modified endografts have to play in urgent aortic repairs, adding that custom-made devices should be seen as the “first source” for elective repair.

On the importance of gaining experience with fenestrated EVAR in general, and of quality control in modifying a device. Tsilimparis commented that many surgeons had made the mistake of trying to learn the fenestrated endograft technique and how to modify the device simultaneously, rather than opting to use custom-made devices initially. “It is important to start with easy cases with custommade devices, and rely on surgeon-modified [devices] if you have the experience with these, and also if you feel very comfortable with the stent grafts and the technique overall.”

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July 2020 | Issue 86

Interview

Profile

Hence Verhagen

Hence Verhagen talks to Vascular News about his career in vascular surgery to date. He lauds the impact of the shift from open to endovascular techniques but stresses that treatment results must get “a lot more durable” in the future and encourages those starting a career in vascular surgery to go out of their comfort zone “regularly”. The incoming 2021 president of the European Society for Vascular Surgery (ESVS), Verhagen considers what he would like to achieve in this role and what we can expect from the upcoming annual meeting, which, like many other meetings in the wake of COVID-19, will be a virtual event.

What led you to become a vascular surgeon?

I had the pleasure of meeting Professor Bert Eikelboom early during my time at medical school. He inspired me and offered me the opportunity to do a few research programmes. After a few years, he offered me a PhD position. Eikelboom was a prominent leader in the field of endovascular repair of the aorta in the Netherlands and Europe and his work convinced me that I should pursue a career in vascular surgery.

Who have been your professional mentors, and what lessons did you learn from them?

I actually had a few mentors that were, in different ways, crucial to key decisions in my career. The first was Bert Eikelboom, as mentioned above. The second was Professor Theo van Vroonhoven, my trainer and mentor in general surgery. He was a vascular surgeon as well and was co-founder of the Dutch Vascular Society.

He taught me never to settle for any result less than 100% and was a very inspiring surgeon. The third was Professor Jan Blankensteijn, who guided me through the first years of vascular surgery, both clinically as well as scientifically. An exceptionally talented person, I learned a huge amount from him. He also introduced me to my fourth mentor, Professor Geoff White from the Royal Prince Alfred Hospital, Sydney, Australia, who was the friendliest and most inspiring surgeon I have ever met.

He introduced me at the right time and in the right place to the whole aortic endovascular revolution. He turned out to be the most influential person for my further career. We became very close over the years and so did our families. I still think about him (and miss him) every day. The fifth mentor is Professor Frans Moll, who I worked with in Utrecht, the Netherlands. We share the same professional hobbies and passion and we turned out to be quite a successful team. He pushed my career further in an incredible way. I admire—and try to copy—his never ending desire to innovate, improve, and keep on learning new techniques and technologies.

Again, a very inspiring and charming surgeon.

What are the most significant ways you have seen the vascular field develop over the course of your career?

Obviously, the whole shift from open to endovascular techniques revolutionised the vascular surgery arena.

It made the profession so much more interesting and appealing. When I look at all the minimally invasive interventions we do, how this impacts the life of our patients and their relatives, and the enthusiasm with which the young vascular surgeons master these techniques, I can be proud that I was part of this huge change in landscape. What a difference this is from my first few years in the field!

What developments would you most like to see realised in the next decade?

We are doing alright but treatment results need to get a lot better and a lot more durable. There is still a lot

to gain there. I cannot think of a world where we go back to open surgery. I really do not see a push towards open surgery, the way that the UK National Institute for Health and Care Excellence (NICE) has tried to accomplish, for example.

They do have a point though: for a variety of reasons, many—particularly young— vascular surgeons are hesitant to do open repair, resulting in endovascular treatments with very moderate results that probably should not have been done. The answer is to make endovascular treatment better and more durable, not to turn the clock back.

Which new paper presentation has caught your attention?

The Katsanos paper [Katsanos et al, “Risk of death following application of paclitaxel-coated balloons and stents in the femoropopliteal artery of the leg: A systematic review and meta-analysis of randomised controlled ttrials,” Journal of the American Heart Association, December 2018] is in my top 5% because really, nobody truly understands what is happening there, which makes it very interesting.

What do you hope to achieve as president of the ESVS?

My goal is an even better connection between the ESVS, the academy, and young vascular surgeons for whom the additional value of an ESVS membership is more clear.

Furthermore, I will also try to further professionalise the way the ESVS is run, and make improvements to the business model to have a more sustainable organisation.

Finally, reaching out to other professional societies including cardiology, radiology, vascular medicine, angiology, and cardiothoracic surgery to establish better interaction is high on our agenda.

Make sure to keep an open mind to change and go out of your professional comfort zone regularly.”

What advice would you give someone starting their career in vascular surgery?

Make sure to keep an open mind to change and go out of your professional comfort zone regularly, which is the only way to truly learn and stay young.

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

What are the biggest challenges currently facing vascular surgery?

What are your current areas of research and work?

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

There are so many proud moments, I really could not pick one above the other: from seeing your fellow perform a successful intervention, saving a patient’s life during an emergent intervention, to presenting important new data on a conference. So much to be proud of!

I am still mainly focussed on aortic pathology, both clinically as well as scientifically. I am considering a change of focus, but it is too early to say.

Inconvenience. In general, vascular surgery groups are too small to have decent on-call rosters.

Many, especially young people, see that as a huge disadvantage, which is driving many away from this great profession.

I keep on seeing memorable cases, some with exceptionally successful outcomes, some (sometimes unexpectedly) not so. Even after more than 20 years,

Issue 86 | July 2020

Interview

19

Fact File

Education and staff appointments

2007–present Professor, chief of Vascular Surgery, and head of training, Erasmus University Medical Center, Rotterdam, the Netherlands 2002–2007 Assistant professor Vascular Surgery, University Medical Center Utrecht, Utrecht, the Netherlands 2002–2003 Fellowship Vascular Surgery, University Medical Center Utrecht 2001–2002 (Endo) Vascular fellow, Royal Prince Alfred Hospital, Sydney, Australia 1996–2001 Surgeon in training 1993–1996 PhD student Vascular Surgery/ Haematology, University Medical Center Utrecht 1991 House officer Obstretics and Gynaecology, Harare Central Hospital, University of Zimbabwe, Harare, Zimbabwe 1990 House officer Internal Medicine, St Mary’s Hospital, London, UK 1984–1992 Medical School, Utrecht University, Utrecht, the Netherlands

Leadership roles (selected)

Board member Dutch Endovascular Forum Advisory board member Dutch Heart Foundation Founder Heart and Vascular Center, Erasmus University Medical Center Board member Erasmus University Trust Fund

Scientific and educational roles (selected)

new clinical issues appear regularly and that makes is so interesting and impossible to get bored.

How do you like to spend your time outside of work?

Outside of work (and that is a challenge) my hobbies and interests include spending time with my four children, sports, and travelling. We recently started the Erasmus MC – Medtronic Academy for optimising vascular disease awareness and education in subSaharan Africa: a wonderful educational programme with hopefully a large impact on many lives in that particular area of the world.

What has been the fallout of COVID-19 for vascular patients?

All elective interventions were stopped. Interventions were only considered if aneurysms reached a diameter of 7cm or larger. Patients with symptomatic carotid

stenoses or limb threatening ischaemia were intervened on as before COVID-19. For now, it is impossible to know what the extent of the “collateral damage” is or will be in the near future. Many vascular surgeons have noticed that outpatient wound care was suboptimal the last months resulting in an increase in patients with very severe wound problems recently.

What form will the ESVS annual meeting take this year?

We have chosen to opt for a completely digital ESVS Month! Every Tuesday and Thursday between 29 September and 22 October, the ESVS will welcome vascular surgeons, vascular surgeons in training, vascular nurses and sonographers, and other related specialists during its live webinars and interactive educational sessions. The programme committee has done an incredible job in selecting an ultra-educational and inspiring programme.

Education and Training committee member, European Society for Vascular Surgery Board member, CV Research “Coeur”, Erasmus Medical Center Head of training programme fellowship Vascular Surgery, Erasmus Medical Center

Scientific society memberships

Dutch Surgical Society Dutch Society for Vascular Surgery European Society for Vascular Surgery Society for Vascular Surgery International Society for Vascular Surgery International Society for Endovascular Specialists

Guidelines

Writing committee, Management of descending thoracic aorta diseases: Clinical practice guidelines of the European Society for Vascular Surgery (ESVS), Eur J Vasc Endovasc Surg 2017 Jan;53(1):4–52

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Paclitaxel Highlight Session, CX 2019

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PERIPHERAL

Issue 86 | July 2020

CX 2020 LIVE: Vascular Access session showcases new technologies, while debate on place of endovascular fistula creation continues

The CX 2020 LIVE Vascular Access Consensus session sparked global interest, with chair Nick Inston (Birmingham, UK) and moderator Domenico Valenti (London,

Vascular access UK) taking questions from 17 countries, spanning South America to South East Asia. The session pinpointed the latest developments in this fast-moving field, including cutting-edge technologies, such as endovascular arteriovenous fistula (endoAVF) creation, the use of covered stents in dialysis access, and the advantages of external support.

JENNIFER HANKO (BELFAST, UK) opened with the benefits and drawbacks of peritoneal dialysis compared to haemodialysis, stressing the importance of choosing “the right access, for the right patient, at the right time”. Polling revealed that audience members were split on whether endovascular fistula creation is the future, with Inston concluding that the topic is “still up for debate”.

“All modalities must be considered” when planning access, Hanko began, including peritoneal access, haemodialysis, conservative care “as appropriate,” and the patient’s suitability for kidney transplantation.

She suggested that more patients could benefit from peritoneal dialysis if they had it first, but also stressed that this approach is only recommended for certain patients.

Among the factors that predict a failure to successfully commence peritoneal dialysis are the presence of cardiovascular disease, low serum albumin, and age greater than 75 years. Furthermore, Hanko noted that there is “no consensus” on when a patient should proceed to both peritoneal dialysis catheter and back-up fistula creation if there were concerns that peritoneal dialysis was a suitable modality.

Patients with no fistula options “should be encouraged to do peritoneal dialysis if possible,” Hanko advised the CX 2020 LIVE audience.

“Traditionally, we have advocated radiocephalic fistula first.” However, Hanko acknowledged that there

Experience with endoAVF “encouraging,” but more data needed

New era of vascular access must move beyond “fistula first” approach

ROBERT JONES (BIRMINGHAM, UK) provided a technology update on endoAVF, looking at the performance of two catheter systems—Ellipsys (Avenu Medical) and WavelinQ (BD).

One of the major benefits with this approach is the lack of surgical trauma, “therefore potentially less intimal hyperplasia and stenosis formation”.

Jones also highlighted: “Both of these catheter systems utilise the forearm vascular anatomy to create an endoAVF, an area that is not typically used for surgical fistula creation”.

He added: “Multiple specialty operators can use both devices to create successful fistulas and this potentially can lead to a decreased waiting time for definitive access. Of utmost importance is patient preference.”

DAVID KINGSMORE (Glasgow, United Kingdom) also advocated a patient-tailored outlook to vascular access, describing in his presentation the “old era” approach of “fistula provision for all”—typified, he said, by European Society for Vascular Surgery (ESVS) 2018 guidelines on vascular access—as being ripe for change, in particular through greater use of early cannulation arteriovenous grafts (ecAVGs).

Kingsmore made the point that while, for many patients, fistulas remain the ideal treatment option, “for half [of patients] they are not”. Likewise, catheters for some patients are ideal, he commented, but for most they are not. “We have to consider what the patient aim is, and how to incorporate transplant with our vascular access planning. Overall, early cannulation grafts are certainly under-utilised and their outcomes can be optimised. We have an opportunity for a new era, to integrate and tailor optimal practices to patients’ aims, choices, and needs.”

Following his presentation, Valenti asked Kingsmore

Edited case illustrates endovascular fistula creation with WavelinQ PANAGIOTIS M KITROU (PATRAS, GREECE) demonstrated an edited case on the endovascular creation of an arteriovenous fistula using WavelinQ. The device consists of two rapid change catheters, with the arterial catheter inserted first.

Kitrou detailed the steps involved in preparing the patient, as well as the other devices required for the procedure. The issue of costs associated with endoAVF was raised in the discussion that followed.

Other queries on time-to-fistula maturation in endoAVF, and whether it is necessary to coil deep veins, were submitted.

23

are situations in which this may not be appropriate.

She pointed out that patient choice is also an important factor, summarising that the approach at the Belfast City Hospital “is no longer fistula first. It is the right access, for the right patient, at the right time”.

“A partnership”: Discussion highlights importance of working with patients to reach a solution Valenti opened the discussion after Hanko’s presentation, asking how patient choice influences her decision-making in fistula creation. “I think it is a partnership,” Hanko replied, adding that “it is about working with [patients] to get to a solution”.

Inston asked whether it is common practice to insert a peritoneal dialysis tube at the same time as creating a fistula, to which Hanko responded that it is not something she would advocate for most patients. But she acknowledged that a “small subset, probably less than 5%” would benefit.

“I think we can all testify to the fact that when patients fail peritoneal dialysis, we are not always that great at having their vascular access ready”.

In response to a question from the UK, about what to do if fistula formation is not what the patient wishes, Hanko said she would still strongly recommend it, and get additional education for the patient on the risks versus the benefits of a catheter compared to a fistula.

We have an opportunity for a new era, to integrate and tailor optimal practices to patients’ aims, choices, and needs.”

The audience were split over the future of endoAVF whether the “fistula first” approach has contributed to the underutilisation of grafts, to which he replied: “We are victims of looking at procedures rather than patients, [and] not integrating with other services and patient outcomes. Nick [Inston] has talked before about the outcomes and the changing success rate.

We have got to bear in mind that dialysis has evolved substantially over the years, and transplant has evolved even more.”

Covered endoprostheses are “the gold standard” for venous anastomosis with prosthetic vascular access An edited case was presented by Matteo Tozzi (Varese, Italy) on the use of a selfexpanding covered endoprosthesis—Viabahn (Gore)—to treat AVF failure at the venous anastomosis.

Tozzi reviewed the case of a 69-year-old male receiving haemodialysis for diabetic nephropathy, starting the dialysis with a tunnelled central

venous catheter filter for a bloodstream infection.

Responding to a question from the audience, Tozzi outlined that “in the cephalic arch, the stent graft is the first option for the stenosis because all other techniques such as drug-coated balloons, plain balloon or high-pressure balloon fail very fast”. In this instance, a covered stent graft is “the gold standard”.

Howe that “i choice the en

Issue 86 | July 2020

Paclitaxel

Real-world analysis demonstrates lower long-term mortality after DCB angioplasty of femoropopliteal lesions In a real-world retrospective analysis, recently published in JACC: Cardiovascular Interventions, the long-term mortality rate was lower after drug-coated balloon (DCB) angioplasty than after plain balloon angioplasty of femoropopliteal lesions. First author Tanja Böhme, senior author Thomas Zeller (both UniversitätsHerzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany), and colleagues note that known co-morbidities, risk factors, and disease severity were identified as mortality predictors, but not paclitaxel.

BÖHME ET AL CITE the continuing debate surrounding the association between paclitaxel and late mortality in femoropopliteal interventions as the principal motivation behind their study.

They note that the conversion was sparked by the December 2018 meta-analysis by Konstantinos Katsanos (University of Patras, Patras, Greece) et al, which suggested an increased long-term mortality risk following femoropopliteal angioplasty using paclitaxel-coated devices.

“It remains unclear whether treatment of femoropopliteal lesions with a paclitaxel-coated DCBs leads to an increase in all-cause mortality in a real-world setting,” Böhme and colleagues note, adding that health insurance data-based analyses even suggest a survival benefit for patients with paclitaxel-coated DCBs, referring specifically to a presentation given

by William Schuyler Jones (Duke Heart Center, Durham, USA) at the TransCatherTherapeutics 2018 conference (TCT; 21–25 September) and a paper by Eva Freisinger (University of Münster, Münster, Germany) et al published last year in the European Heart Journal.

The authors of the present

study therefore set out to evaluate the long-term mortality after paclitaxel DCB use and plain balloon angioplasty of femoropopliteal lesions in real-world practice.

Böhme et al conducted a retrospective mortality analysis of patients with at least three-year follow-up who underwent balloon-based endovascular therapy of femoropopliteal lesions. Between January 2011 and June 2016, 7,357 patients with femoropopliteal lesions were treated with either a DCB or plain balloon angioplasty; 1,579 fulfilled the study criteria. They detail that 514 patients were treated with plain balloon angioplasty without crossover to a paclitaxel-coated device during followup, and 1,065 patients were treated with DCB angioplasty.

The primary endpoint of the study was the difference in all-cause mortality rate after plain balloon and DCB angioplasty.

Secondary endpoints included threeyear and five-year mortality rates, the relationship between DCB length as a measure of drug concentration and mortality, as well as search for mortality predictors including type of treatment, age, gender, hyperlipidaemia, diabetes mellitus, renal insufficiency, cerebral artery disease, coronary heart disease,

VIVA Physicians publishes analysis evaluating mortality and paclitaxel-coated devices An individual patient-level data (IPD) analysis of the safety of paclitaxelcontaining devices (PTXD), conducted by VIVA Physicians, identified an absolute 4.6% increased mortality risk associated with PTXD use.

T

Tanja Böhme

and Rutherford-Becker class 1–3 versus 4.

The authors report that mortality incidence at mean follow-up of 52±20.5 months (median 51 months) was 27.8% after plain balloon angioplasty and 16.9% after DCB (p<0.001). Equally, for a cohort excluding patients over 80 years of age, the mortality rate after plain balloon angioplasty treatment was significantly higher (23.6% vs. 12.3%, p<0.001).

In addition, they note that DCB length was not correlated to mortality rate and, after propensity score matching, independent mortality predictors were plain balloon angioplasty treatment (p=0.035), age (p<0.001), stroke (p=0.025), and renal insufficiency (p=0.007).

In the discussion of their findings, the authors remark that, despite including a large number of patients with long-term follow-up in this single-centre study, they

All-comers randomised clinical trials are necessary to prove this longterm survival benefit and to identify the potential cause.”

he analysis, based on the most complete available data set of mortality events from PTXD randomised controlled trials, was led by Krishna Rocha-Singh (Prairie Heart Institute, Springfield, USA) and has been published in Circulation.

VIVA’s analysis included 2,185 subjects across 8 studies with a median follow-up of 4 years; ultimately, VIVA’s analysis identifies a weaker mortality signal than was initially reported in December 2018 by Katsanos et al.

VIVA Physicians’ paper, “Mortality and paclitaxelcoated devices: An individual patient data metaanalysis”, also acknowledges no drug-dose relationship was established.

This is VIVA’s second published article on the risk of increased late mortality in the context of PTXD from their independent, patient-level data analysis.

The current study includes subjects whose data were previously lost to follow-up.

Manufacturers of US Food and Drug Administration (FDA) approved and commercially available devices

25

were not able to confirm the findings of the Katsanos et al meta-analysis. “In this real-world study, even after adjusting for confounding variables, we found a significant mortality benefit for patients treated with DCB,” they write.

On the subject of mortality, the authors note that death was most common due to cardiovascular events. However, in a significant number of cases, the cause of death remained unknown.

Comparing their results to those of the Katsanos et al metaanalysis, Böhme and colleagues write that the mortality rates of their study are higher, “as expected”. They cite a potential reason for this as being Katsanos et al’s focus on randomised controlled trials, which “usually exclude patients at higher mortality risk, such as patients with end-stage renal disease. In addition, only patients with a certain life expectancy are included—frequently excluding elderly and frail patients results in a selection bias”.

Potential limitations

The authors note that the single-centre observational design of their study is a potential limitation but defend the retrospective data analysis, which they state “does not affect the primary study endpoint of all-cause mortality”. They also note that this study design represents strength in terms of excluding potential confounding variables due to a standardised prescription of secondary preventive drugs, such as statins and antiplatelet agents following the intervention. Another limitation they mention is that in almost half of the study population the cause of death could not be determined.

Böhme et al conclude that, in this real-world study, treatment of femoropopliteal lesions with DCB excluding patients with ischaemic wounds resulted in a survival advantage.

However, they note that all-comers randomised clinical trials are necessary to prove this long-term survival benefit and to identify the potential cause, such as a mobility benefit resulting in a positive risk profile modification as a result of a patent vessel.

in the USA provided de-identified data for VIVA’s independent analysis.

Cox proportional hazards one-stage meta-analysis models using intention-to-treat (ITT) methods were used for the primary analysis. A secondary analysis of additionally recovered missing vital status data was performed.

Read more on page 26

Manufacturers of FDA approved and commercially available devices in the USA provided deidentified data for VIVA’s independent analysis.”

26

July 2020 | Issue 86

Paclitaxel

COMPARE trial highlights efficacy of low-dose paclitaxel balloons

CX 2020 LIVE addresses ongoing investigation into paclitaxel safety The first session of CX 2020 LIVE saw participants from Stockholm to Santiago asking questions and engaging with leading vascular figures on the ongoing investigation into the safety of paclitaxel devices in the treatment of peripheral arterial disease (PAD).

ROGER GREENHALGH (LONDON, UK) chaired the event, with Andrew Holden (Auckland, New Zealand) moderating the panel discussion.

“High impact” of VIVA individual patient data analysis THE IPD ANALYSIS OF THE SAFETY OF paclitaxel-containing devices conducted by VIVA Physicians and detailed on page 25, identified an absolute 4.6% increased mortality risk— corresponding to a 38% increased relative mortality risk—associated with their use. This is a weaker mortality signal than that initially reported in December 2018 by Katsanos.

Presenting these results at CX 2020 LIVE, Gary Ansel (Columbus, USA) remarked: “The VIVA IPD has, and will continue to have, [a] high impact due to the richness of the dataset”.

Nearly two-thirds of the CX 2020 LIVE audience believe the VIVA Physicians’ IPD analysis does not provide consensus on the ongoing paclitaxel debate “once and for all”. When asked “Does the VIVA IPD settle this once and for all?”, 63% answered “no”.

Greenhalgh concluded: “What we have learnt today, from various pieces of data, is that this matter is not settled. What I personally like is that the FDA’s comments have left room for doctors to decide what they consider to be the right thing to do for the patient.”

SABINE STEINER (LEIPZIG, GERMANY) told the CX 2020 LIVE audience that the COMPARE trial, the first head-to head comparison of two paclitaxel-coated DCBs, showed “excellent efficacy” at one year in both arms. There was a similar patency at one year with the low-dose (2µg/mm2) Ranger DCB (Boston Scientific) compared with the higher dose (3.5µg/mm2) IN.PACT Admiral DCB (Medtronic).

Steiner told the CX 2020 LIVE audience that the COMPARE trial results “cannot identify any signal for a relationship between paclitaxel dose and mortality, at one year or beyond”.

The COMPARE trial, published in the European Heart Journal, was a prospective, randomised, non-inferiority trial of high- versus low-dose paclitaxel DCBs for femoropopliteal interventions. All patients enrolled in the study had PAD categorised as Rutherford class 2–4.

The trial met both its primary efficacy (primary patency through 12 months) and primary safety (freedom from major adverse events through 12 months) endpoints.

Steiner says that the investigators, led by Dierk Scheinert (Leipzig, Germany), “will follow the patients up to five years by telephone calls in order to gain safety information”.

Focusing on all-cause mortality, Steiner noted that the COMPARE trial data show “an overlapping of KaplanMeier curves through four years”, indicating “no signal for any relevant difference [between the two different paclitaxel dosages] with respect to mortality”. She continued: “Actually, death rates are rather low. After two years, where we do have quite a good follow-up, we observe a death rate which is around 3%”.

When looking at individual causes of death, Steiner shared that the research team did not see any “clear signal of an excess rate of a specific cardiovascular or non-cardiovascular death subtype.“Importantly,” she expanded, “the same holds true, or we see a similar pattern of causes of death, for the six patients who died in the high-dose DCB group. Importantly, no death was considered procedure- or device-related by the clinical events committee.”

Holden praised Steiner for bringing “new information

that we are seeing for the first time” to CX 2020 LIVE. Prompted by a question from Greenhalgh, Steiner clarified that the COMPARE trial was never designed to compare mortality between the Ranger DCB and the IN.PACT Admiral DCB, but rather efficacy. “What I would really like to highlight,” she stressed, “is that we have these meta-analyses showing us a signal that even for efficacy there will be a difference with respect to dose, so a higher dose will be more efficient.

“This was really the background of the COMPARE trial, that we wanted to have a non-inferiority design with respect to efficacy and primary patency. Here, we did not see a difference, which is really in contrast to the results from the meta-analyses.”

Holden said he “entirely” agreed with Steiner’s conclusions, adding: “I think it [the dose model] is the weakest part of the original [2018, Katsanos et al] metaanalysis.” Addressing Steiner, he said, “You have really shown that a low-dose device is as efficacious [as a high-dose one], and that there is no safety advantage or disadvantage.”

Steiner acknowledged that although she and her colleagues did not observe a signal with respect to mortality, the numbers in the COMPARE trial “are clearly very small in general, so there is a low mortality rate—we are definitely not powered for this question [detecting an association between increased mortality risk and paclitaxel dose].”

US FDA assessing “totality of evidence”, calls out specific value of individual patient-level data sets PROVIDING AN UPDATE ON THE PACLITAXEL late-mortality signal from the US Food and Drug Administration (FDA) perspective, Misti Malone (Centre for Devices and Radiological Health, US FDA) said that the agency is in the “signal discernment/refinement phase” of the ongoing investigation.

Following the FDA Advisory Committee Meeting last summer (19–20 June, Washington, DC, USA), approved paclitaxel devices have remained on the US market with labelling updates that discuss ongoing uncertainties regarding the signal, as well as the conclusions of June’s meeting. At the time, the agency agreed that the mortality signal existed, but that the signal magnitude was uncertain.

“Because patient comorbidities, extent of disease, and lesion characteristics play a role in clinical outcomes, [the] FDA believes it is important for physicians to determine what patients are considered [at] high risk of restenosis, and they have a favourable risk–benefit profile from treatment with paclitaxel-coated devices.”

Clinical trials are continuing with revised informed consent and increased patient follow-up. Additionally, the FDA has also promoted efforts to increase trial robustness, such as attempts to reduce “missingness”.

“We continue to collaborate with investigators of observational datasets, and through groups such as RAPID, a multi-stakeholder collaboration made of clinicians, industry members, and regulators aiming to improve the real-world evidence ecosystem, from data collection to analysis,” Malone explained. “These collaborations may provide insights into remaining questions, such as the precise magnitude of the signal,

the mechanism for late-term mortality, and the benefit– risk profile in real-world patient populations.”

Malone stressed the importance of collaboration, finishing by saying: “This is a global issue that requires global collaborations.”

Moderator Holden said he has found large populationbased studies “reassuring”, and asked for the FDA’s thoughts on these types of analyses.

“We value the totality of evidence,” Malone replied, “be it from randomised controlled trials, single-arm trials, or observational datasets. The devil is in the details for many of these trials, in which we identify how many patients have been followed-up to four or five years, which is when the signal was noticed in our data sets.

Many of these data sets have up to 50% missingness at this point, and although we may assume missingness accepts some level of randomness, it may not, so we typically need very robust, high-quality data with long follow-up in order to discern this mortality signal.

“So, we do value these observational datasets, and as part of the RAPID group, we are compiling all of the datasets we are aware of, and looking at the level of evidence and our confidence in the data that has been evaluated.”

Specifically commenting on individual, patient-level analyses, such as the VIVA individual patient-level data (IPD), Malone said: “We find those very valuable because we can dive into the details, we can see how the individual patients are affected, rather than looking at summary data. The higher-level meta-analyses help to guide us to our next step to do a more in-depth analysis.”

Issue 86 | July 2020

Peripheral arterial advances

Covered balloon-expandable stents are effective treatment options for aortoiliac occlusive disease

CX 2020 LIVE: Strong support for re-lining peripheral arteries and rivaroxaban use for widespread atherosclerosis In a series of Podium 1st presentations from world-class faculty, CX 2020 LIVE attendees heard the latest data on peripheral arterial disease management and an evaluation of different types of stents, including covered and helical options for challenging lesions. In total, nearly 5,000 people, from 125 countries, have registered for the inaugural, CMEaccredited series of 10 sessions. The first CX 2020 LIVE session dedicated to peripheral interventions has been viewed by 3,222 people, tuning in from five continents.

AN OVERWHELMING MAJORITY of 81% answered “yes” in agreement with the comment “I like relining”. The poll followed three sessions that looked at the concept of “relining”, using covered stents for the management of complex aortoiliac occlusive disease. Livestream attendees heard that the surgical management of complex lesions, which may be heavily calcified, is difficult, and may lead to rupture.

Meanwhile, the endovascular approach is gaining ground. Amer Zanabili (Oviedo, Spain) presented an edited case demonstrating the relining of an occluded, long TASC D iliac lesion, showcasing the potential of this technique. The polling results that followed then revealed an enthusiasm for this endovascular approach.

Roger Greenhalgh (London, UK) chaired the discussion, and Gunnar Tepe (Rosenheim, Germany) joined him as moderator for the session.

Three-quarters of the audience agreed with the statement: ‘I will use rivaroxaban in PAD lower extremity revascularisation.”

JEAN-PAUL DE VRIES, (GRONINGEN, THE NETHERLANDS) reported the key findings from a systematic review (published in the Journal of Vascular Surgery) of covered balloon-expandable stents for the management of aortoiliac occlusive disease. De Vries said: “Covered balloon-expandable stents are effective treatment options for aortoiliac occlusive disease as evidenced by the high rates of technical success and patency in all the stent grafts at one-year follow-up.

They are preferred over bare metal stents for complex aortoiliac lesions, based on the documented five-year patency results for Advanta V12 in the COBEST trial.”

Overall, the studies explored five different stents:

27

Advanta V12 (Getinge), Viabahn VBX (Gore), Lifestream (BD), BeGraft (Bentley), and Jostent (Abbott).

De Vries said the rates of technical success and primary patency were both high, adding that that primary patency, at one year, “was 96.6% for Viabahn VBX and that is comparable to the Advanta V12 [83.6–96.4% at one year] and 94.4% for BeGraft [one-year data were not available for Lifestream or Jostent].” He further noted that five-year data were only available for Advanta V12, showing a primary patency rate of 74.7% and a freedom from target lesion revascularisation rate of 67.4%. So far, the Advanta V12 is the only balloon-expandable stent graft with five-year outcomes, which are good.

De Vries noted that comparative trials were required because, at present, the data are insufficient to provide “any proof that the new-generation devices perform better than the former generation ones”. However, he observed that three-year data for Viabahn VBX had recently been published and these were comparable to three-year results for Advanta V12.

“Excellent” three-year results with Viabahn VBX relate to stent graft’s unique design ANDREW HOLDEN (AUCKLAND, NEW ZEALAND), in his talk, further expanded on the three-year data from the VBX FLEX investigational device exemption (IDE) trial.

The objective of the study, he explained, was “to evaluate the safety and efficacy of the VBX stent graft [Gore] for the treatment of arterial occlusive disease in patients with de novo or restenotic lesions in the common and/ or external iliac arteries”. The primary outcome was a composite of major adverse events at nine months.

Overall, in VBX FLEX, 234 devices were implanted into 213 lesions (134 patients) across 27 sites.

Holden said: “The Viabahn VBX is made up of a double polytetrafluoroethylene (PTFE) layer with independent stainless steel rings that give it flexibility and conformability.”

He reported that with the three-year data, freedom from target lesion revascularisation “was a very impressive 91.2%, which improves to 98.1% when we evaluate the clinically-driven target lesion

revascularisation.” Furthermore, according to Holden, “a number of clinical parameters remained improved at three years,” including the Rutherford category, resting ankle brachial index, and walking impairment questionnaire scores.

“In fact, of the patients who were at Rutherford 0 by three years, 80% had started from a baseline of Rutherford 3 or 4. Overall, 92% of patients improved at least one Rutherford category at three years,” he explained. “The VBX FLEX clinical study is truly a realworld study, including complex aortoiliac occlusive disease (TASC II C and D lesions, 32.1%), that has shown excellent results. […] These are no doubt due to the unique design of this device,” Holden concluded.

The ensuing discussion emphasised that covered stents have become the first-line treatment for complex aortoiliac disease. “What we have seen, particularly in complex disease, is a real practice shift towards covered stents.”

Rivaroxaban reduces risk of comorbidities in patients with peripheral arterial disease THREE-QUARTERS OF THE CX 2020 LIVE audience agreed with the statement: “I will use rivaroxaban in peripheral arterial disease lower extremity revascularisation”. Polling took place following a talk from Rupert Bauersachs (Darmstadt, Germany) giving the results of the VOYAGER PAD trial.

“After revascularisation, one in five peripheral arterial disease patients will suffer from acute limb ischaemia, major amputation, acute myocardial infarction, ischaemic stroke, or cardiovascular death within three years,” Bauersachs told CX 2020 LIVE delegates. The VOYAGER PAD trial, he went on to relate, therefore set out to evaluate the safety and efficacy of 2.5mg bid rivaroxaban plus aspirin versus aspirin alone to reduce thrombotic vascular events after peripheral revascularisation.

Bauersachs reported: “Rivaroxaban 2.5mg bid on top of aspirin was associated with a significant 15% reduction in major adverse limb events and major adverse cardiac events, with no significant increase in TIMI [thrombolysis in myocardial infarction] major bleeding. Acute limb ischaemia was significantly reduced by 33% compared to current standard of care.”

The study therefore met both its primary efficacy endpoint—a novel outcome measure combining major adverse limb events and major adverse cardiac events— and its primary safety endpoint—TIMI bleeding.

“Dual pathway inhibition treatment is the only antithrombotic regimen proven for significant benefit of the peripheral revascularisation in a large, randomised

controlled trial,” Bauersachs concluded.

As questions began to flood in from Europe and Asia, it became clear that many pertained to Bauersachs’ rationale for using such a low dose of rivaroxaban. “It is a very low dose, 2.5mg,” Bauersachs agreed, adding, “the actual daily dose for treating venous thromboembolism, for example, is 30mg. Because it is such as low dose, it has to be given twice a day.

“As we know, these are high-risk patients, so the objective was, with a low dose of anticoagulants on top of antiplatelets, to reduce those outcomes.”

Responding to a question asking why a low dose of warfarin was not used, Bauersachs said that previous VKA trials had shown “unacceptably high rates of bleeding” and had lacked efficacy.

Lastly, a CX 2020 LIVE viewer from Malaysia queried the recommended length of time for patients to take rivaroxaban plus aspirin, after revascularisation. In agreement with Tepe, Bauersachs said that it would be a long-term treatment.

“I think the point we are talking about here,” Greenhalgh said in summary, “is that patients with that sort of peripheral arterial disease will have all of these other issues and comorbidities. It is not a standalone condition, it is a marker of arterial disease throughout the body’s vascular system; the more peripheral, the higher the likelihood it will be severe elsewhere in the body.

“So, the use of rivaroxaban enables the complications that come with this complex disease to be reduced, and comorbidities can be handled better.”

Continued on page 28

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July 2020 | Issue 86

Peripheral arterial advances

MIMICS-2 study three-year results: Swirling flow “is the answer” Continued from page 27

Absence of longterm benefit from revascularisation in claudicants, according to five-year data A LIBERAL STRATEGY OF revascularisation in patients with intermittent claudication resulted in a substantial improvement in health-related quality of life for two years, but this benefit was lost at five years. This is the conclusion presented by Joakim Nordanstig (Gothenburg, Sweden), after he shared the five-year results from the IRONIC randomised trial. The IRONIC trial investigators aimed to study the clinical effectiveness and cost-effectiveness of the two most widely offered treatment strategies for patients with intermittent claudication: lower limb revascularisation in combination with best medical treatment and exercise advice, versus best medical treatment and exercise advice only.

Speaking to the fact that the IRONIC trial included femoropopliteal lesions and aortoiliac lesions alike, Greenhalgh commented, “Assessors would say that the expectation of success or reconstruction over five years with the aortoiliac is far better than with the femoropopliteal. Some would argue that you should keep them separate because the expectation is different. They may present with intermittent claudication, so it is one presentation, but a different expectation of natural history.”

THOMAS ZELLER (BAD KROZINGEN, GERMANY) presented the three-year results of a US investigational exemption device study, MIMICS-2, for which he is the European principal investigator. The prospective, singlearm, multicentre clinical trial found comparable efficacy and safety results for the helical BioMimics 3D stent (Veryan Medical) and drug-coated balloons or drugeluting stents available on the market.

The primary endpoint for this study consisted of a safety endpoint, composite of deaths, major amputation, clinically-driven target lesion revascularisation through 30 days, and an effectiveness endpoint defined as primary patency at 12 months. The proportion of chronic total occlusions was 30%, and moderate-to-severe calcification was seen in 46% of lesions.

Both device and technical success was 100%, and the primary safety and primary efficacy endpoints were reached. Zeller told the audience that these results represent “a clear achievement” for the BioMimics 3D stent.

Three-year freedom from clinically-driven target lesion revascularisation was 81% for the entire patient cohort, and there was “only” a decrease by 8% of freedom from reintervention between one and three years, Zeller related.

Describing the device, Zeller said: “The BioMimics 3D stent represents a new bare metal stent, designed with a helical centreline, which imparts a nonplanar curvature to the stented femoropopliteal segment, inducing swirling flow.”

This mimics the natural flow of certain anatomy, Zeller explained. The vessel curvature in the aortic arch and the iliac arteries induces a swirling flow in normal anatomy, known to protect endothelial cells against atherosclerosis and restenosis, he noted. This is based on the lifetime work of Colin Caro (London, UK). Greenhalgh elaborated:

“From what you have just told us, we can say Colin [Caro] was right all along. Swirling flow is the answer.”

Zeller assessed the results of the BioMimics 3D stent from the MIMICS 2 study against those for contemporary devices, including bare metal stents, drug-coated balloons, and drug-eluting stents. “If you compare the BioMimics 3D stent results from the MIMICS 2 study with Supera (Abbott), Zilver PTX (Cook Medical), Eluvia (Boston Scientific), and the IN.PACT Admiral (Medtronic), we can see that freedom from reintervention up to three years is almost comparable,” Zeller said.

Zeller responded to a question from Tepe about the lower event rate seen in the long term, commenting: “It underlines the theory of the basal-protective and endothelial-protective effect of swirling flow. We have the acute phase, where we see the patency failures, which are induced by acute inflammation, resulting in neointimal hyperproliferation and, over time, it evens out regarding the need for reintervention.

“For me, the most interesting question would be: ‘What is the outcome of combining this sort of longterm protective stent design with acute suppression of neointimal hyperproliferation means with an antiproliferative agent?’ That would be a very interesting study to be seen in the future.”

Following Zeller’s presentation, Greenhalgh commented: “[The BioMimics 3D stent represents] a completely new way. We are hearing about the future here. This is not just practical reconstruction—you have just heard how the future is going to go.

“Caro spent his life analysing normal flow of an artery, and he believed that if the blood swirled, then it would reduce the risk of arterial disease, and we have just heard that that is possible, and he was right. We have also had a peek into the future, about how the treatment might be.”

SVS pilots supervised exercise therapy app for peripheral arterial disease patients Doctor-prescribed and -supervised exercise therapy is going digital. The Society for Vascular Surgery (SVS) will begin piloting a ground-breaking app for supervised exercise therapy (SET), for athome use by patients with peripheral arterial disease (PAD).

T

he SET app was introduced on 25 June during the Society’s virtual meeting, SVS ONLINE: “New advances and discoveries in Vascular Surgery,” (20 June–2 July) as part of a session on “Digital health advancements in Vascular Surgery”. SVS member Oliver Aalami (Stanford University, Palo Alto, USA), who is also a member of the SVS Health Information Technology Task Force, is developing the app, powered by Cell-Ed, a remote learning and telehealth company.

How it works

Physicians and healthcare providers must prescribe the app, which will include health education, exercise assessment and goal-setting, and coaching. The app will help schedule exercise, monitor

compliance, and report feedback for later follow-up. Weekly interactions with a live coach will help guide the patient, Aalami told the SVS ONLINE

SVS is launching the app with 50 patients from across the USA. A national launch is planned for the final quarter of 2020.”

SVS supervised exercise therapy application

audience. He added that the app works on any mobile device. SET is a first-line therapy for PAD patients, carried out in hospitals and clinics with physicians “immediately available,” said Aalami.

Therapy generally includes three sessions a week over 12 weeks, with walking alternating with resting periods, for 30 to 60 minutes. The therapy has been shown to lower the need for intervention.

However, despite its success, only 50% of providers in a 2019 survey reported referring patients to a SET programme, though more than 95% would have liked to; transportation is one issue.

National launch planned for late 2020

SVS is launching the app with 50 patients

from across the USA. A national launch is planned for the final quarter of 2020.

In addition, the Vascular Quality Initiative (VQI) is exploring integration for patient-recorded outcomes reporting, which Aalami described as “an exciting development”.

Reimbursement from private and federal insurers is being evaluated.

“We look forward to the participation of all SVS members […] to the benefit of all patients with PAD,” he said.

The SET programme includes a baseline assessment, daily walks five days a week, with podcast content and nudges, benchmark assessment at the half-way point, end-of-programme assessment, health coaching throughout, and optional education units and surveys.

Issue 86 | July 2020

Market Insights

Figure 1

Figure 2

Figure 3

Figure 4

Survey indicates that elective aortic procedures could return to normal levels within three months A BIBA MedTech Insights survey, conducted in May 2020, shows that about 65% of physicians in Western Europe believe their centres could be performing their normal level of endovascular aneurysm repair (EVAR) procedures within three months of COVIDrelated restrictions being lifted. Similar findings were seen for elective endovascular thoracoabdominal procedures (chimney EVAR/fenestrated EVAR) and elective thoracic endovascular aortic repair (TEVAR) procedures BIBA MEDTECH INSIGHTS polled physicians at 238 centres across the globe about how the COVID-19 pandemic has affected clinical practice at their centre. More than half of respondents were vascular surgeons, with the rest ranging from interventional radiologists to angiololgists. Furthermore, 46% of respondents came from the top four European countries: Italy, Germany, the UK, and Spain. Therefore, this article reviews the key Western European findings from the survey.

Overall, in Western Europe, the survey showed a trend for centres

to have seen at least seen some reduction in endovascular aortic (thoracic, thoracoabdominal, and abdominal) procedures, with only a few respondents saying that their centres were continuing to perform all elective and emergency procedures. However, the proportion of centres only performing emergency procedures did depend on the type of procedure or the country. For example, 74% of UK centres were only performing emergency EVAR procedures, but only 22% of German centre were (see Figure 2). Furthermore, of the

UK centres that were still performing at least some elective EVAR procedures, the tendency was for them to have seen a more than 25% reduction in elective procedures.

Looking to the future, the survey asked respondents how soon they thought their centre would be back to performing their usual level of elective procedures. The answers, again, differed depending on the type of procedure. But, the general suggestion was that it would take up to three months for procedures to “return to normal” (assuming all COVID-19 restrictions on performing elective procedures are lifted).

Referring to EVAR, in Western Europe, 30% of respondents estimated that their centre could be back to performing their normal level of elective procedures within one month and 35% guessed between one and three months (65% overall).

29

The majority of respondents also believed that they could “return to normal” in terms of elective TEVAR and Chimney/Fenestrated EVAR procedures within three months.

Only 5% of UK respondents thought that their centre could return to their normal level of EVAR procedures by June (when asked in May) compared with 56% of German respondents. However, 47% of UK physicians estimated that they could get back to normal between one and three months. See Figure 3.

In terms of the measures needed to “clear the backlog” of elective procedures, in the survey overall, increased operating days, adjusted working practices, and increased operating hours were the most common answers.

However, of note, 10% felt no extra measures would be necessary.

See Figure 4.

BIBA Briefings

BIBA Briefings is an online platform (www.bibamedtech.com/bibabriefings) that gives an in-depth analysis of the latest market intelligence from BIBA MedTech Insights (www.bibamedtech.com). It also reviews the latest industry news and pipeline developments.

For sales enquiries (including BIBA MedTech Insights), please contact Merveille Anderson: merveille@bibamedical.com

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July 2020 | Issue 86

VIVA late-breaking trials

VIVA hosts latebreaking clinical trial livestream In keeping with the trend towards digital education necessitated

by COVID-19, Vascular Interventional Advances (VIVA) Physicians recently hosted a late-breaking clinical trial livesteam, showcasing some of the latest data in the vascular field.

iVascular’s Luminor DCB

Luminor DCB shows promise in TASC C and D tibial occlusive disease

Tjun Tang (Singapore General Hospital, Singapore) presented interim sixmonth results of the MERLION trial, a prospective, non-randomised, single-arm, observational, multicentre clinical study evaluating the safety and efficacy of the iVascular Luminor drug-coated balloon (DCB) and Angiolite drug-eluting stent (DES) for treatment of TASC C and D tibial occlusive lesions in Asian patients presenting with chronic limb threatening ischaemia (CLTI) from Singapore.

The clinical primary endpoints were freedom from major adverse events, which was a composite of freedom from device- and procedure-related mortality through 30 days, freedom from major target lower extremity amputation (LEA), and clinically driven target lesion revascularisation (TLR), defined as any reintervention performed for ≥50% diameter restenosis of the target lesion after documentation of recurrent clinical symptoms.

Fifty patients (66 atherosclerotic lesions) were treated with 77 Luminor DCB and 4 Angiolite DES. Ninety-four per cent had diabetes mellitus (DM), 50% end stage renal failure (ESRF), and 80% were non-smokers. Eighty-eight per cent of patients presented with Rutherford Score 5 and 6 wounds. In terms of lesions treated, 71.2% were de novo in nature, 60.6% were TASC C, and the mean lesion length treated was 13.7±9.5cm.

There was 100% technical success but three of 66 (4.5%) lesions required bailout stenting for severe flow limiting dissections, using the Angiolite DES. There were no deaths within 30 days of intervention and six-month amputation free survival (AFS) was 86% (three deaths and four major LEA). Target lesion primary patency at six months was

78.9% (52/57 lesions), freedom from TLR was 91.2% (45/57 lesions), and 68.3% had ≥1 category improvement in Rutherford Score.

Tang concluded that the iVascular Luminor DCB is safe and efficacious in treating highly complex infra-popliteal atherosclerotic lesions in an otherwise challenging frail population of CLTI patients with a high incidence of DM and ESRF. In addition, it is associated with a high technical success rate, six-month target lesion patency, and AFS.

Medicare Advantage cohort: No evidence of increased long-term mortality following treatment with drug-coated devices Eric Secemsky (Beth Israel Deaconess Medical Center, Boston, USA) and

Cox-proportional hazard models. Inverse probability of treatment weighting was used to adjust for differences between groups.

Of 16,796 patients revascularised, 4,427 (26.4%) were treated with drugcoated devices: 3,600 (81.3%) balloons and 827 (18.7%) stents. Following revascularisation, the median follow-up was 2.66 years (IQR 2.02–3.52; longest follow-up 4.75 years).

Treatment with drug-coated devices was associated with similar long-term mortality as nondrug-coated devices (adjusted HR 1.03; 95% CI=0.96-1.10; P=0.39). Results were comparable for patients treated with balloons alone (adjusted HR 1.00; 95% CI=0.92–1.08; P=0.96) or stents (adjusted HR 1.02; 95% CI=0.88–1.18; P=0.78). These findings did not differ based on treatment setting, disease severity, age, sex, or comorbidity burden (interaction p>0.05 for all).

Secemsky concluded that, in this large cohort of MA beneficiaries, there was no evidence of increased long-term mortality following treatment with drugcoated devices. These findings persisted by device type, procedure setting, and patient characteristics.

TOBA II BTK trial: Positive one-year data announced

Intact Vascular announced the positive one-year results from its Tack optimised balloon angioplasty (TOBA) II BTK clinical trial.

Co-principal investigator Patrick Geraghty, professor of Surgery and Radiology at the Washington University School of Medicine in St Louis, USA, presented the one-year results, which successfully demonstrated sustained improvement in Rutherford category, toe-brachial index (TBI), and quality-oflife metrics following management of patients with post-PTA dissection with the Tack Endovascular System (4F), in conjunction with excellent limb salvage and amputation-free survival rates.

“The Tack device is a valuable treatment option that augments an aggressive approach to endovascular limb

The Tack device [Intact Vascular] is a valuable treatment option that augments an aggressive approach to endovascular limb salvage.” colleagues assessed mortality in patients treated with or without drug-coated devices who were insured by Medicare Advantage (MA), an alternative to traditional Medicare that represents >30% of the Medicare eligible population.

Patients treated with or without drugcoated devices for femoropopliteal artery revascularisation between April 2015 and December 2017 were studied using a sample of de-identified MA claims from Optum’s De-identified Clinformatics Datamart Database.

All-cause mortality was assessed through December 2019 using KaplanMeier cumulative mortality curves and

salvage,” commented Geraghty.

Tack implants demonstrated an 81.3% Kaplan-Meier tacked segment patency and a 78.6% Kaplan-Meier target lesion patency, with an 83.1% KaplanMeier freedom from clinically-driven reintervention at one-year.

No fractures, embolisation, or migration of the Tack device were observed, confirming the durability of the minimal metal implants.

Additionally, in the CLTI cohort, a population associated with high rates of amputation and mortality, Tack implants demonstrated a remarkable 96.1% Kaplan-Meier target limb salvage and 89% amputation-free survival.

Boston Scientific’s Eluvia

Excellent vessel patency and good safety profile out to two years in patients treated with Eluvia

Frank Vermassen (Ghent University Hospital, Gent, Belgium) presented twoyear results of the IMPERIAL long lesion sub-study.

The aim of the study was to evaluate the long-term safety and effectiveness of the Eluvia drug-eluting vascular stent system for treating superficial femoral artery and/or proximal popliteal artery lesions >140mm and ≤190mm in length.

The long lesion sub-study was a singlearm branch of the prospective, global IMPERIAL study including patients with lesions >140 mm in length who were treated with Eluvia. Primary patency, patient outcomes, and major adverse events have now been assessed through 24 months.

Fifty patients with mean lesion length 162.8±34.7mm were enrolled (40% with diabetes, 28% with severe calcification, 32% with occlusion). Overall, 24-month clinical follow-up was completed for 43 patients (two died, one withdrew, four missed the visit). At 24 months, the freedom from clinically-driven target lesion revascularisation rate was 86.7% (38/44) and the Kaplan-Meier estimate of primary patency was 77.2%. A total of 88.1% (37/42) of patients presented as Rutherford category 0 or 1 at 24 months and the same number demonstrated improvement of at least one category without the need for TLR. In conclusion, the investigators reported excellent vessel patency and a good safety profile were observed after two years in patients treated with Eluvia in the IMPERIAL long lesion sub-study, despite the lesion complexity.

Furthermore, clinical outcome improvements were sustained through two years.

Long-term safety profile of the Stellarex low-dose DCB reconfirmed

Royal Philips announced the fouryear results from the ILLUMENATE European randomised controlled trial (EU RCT).

The Stellarex DCB cohort demonstrated similar all-cause mortality compared with the control arm through four years. This analysis included missing data found post hoc to achieve a followup compliance of 93.9%, increasing the robustness of the statistical analysis.

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July 2020 | Issue 86

Market Watch

Product News

Cook’s Advance Serenity PTA catheter

Advance Serenity hydrophilic PTA balloon catheter now available in the USA

Cook Medical recently announced that the Advance Serenity hydrophilic percutaneous transluminal angioplasty (PTA) balloon catheter is now available to physicians in the USA. The catheter is manufactured by Surmodics and distributed by Cook Medical.

According to a press release, Advance Serenity is a hydrophilic-coated angioplasty balloon catheter designed to meet the technical needs of clinicians for treatment of patients who suffer from peripheral arterial disease (PAD), which includes below-the-knee disease. The catheter portfolio includes both a 0.014and an 0.018-inch diameter wire guide platform and will be available in a wide variety of balloon lengths and diameters.

“Now that we have added Advance Serenity to our product portfolio of vascular solutions, physicians have one more tool in their toolbox to help treat patients who have PAD,” said Mark Breedlove, vice president of Cook Medical’s Vascular division.

Cook Medical is working to make Advance Serenity balloon catheters available to physicians in Europe in the coming months.

BD announces launch of Halo One thin-walled guiding sheath

BD has announced the launch of the Halo One thin-walled guiding sheath, designed to perform as both a guiding sheath and an introducer sheath, for use in peripheral arterial and venous procedures requiring percutaneous introduction of intravascular devices.

According to the company, the device consists of a thin-walled (1F wall thickness) sheath made from braided single-lumen tubing, fitted with a female luer hub at the proximal end and a formed atraumatic distal tip. The thin-walled design reduces the size of the arteriotomy compared with standard sheaths of equivalent French size to help minimise access-site complications.

A stainless-steel braid construction fortifies the design for extra support.

The Halo One thin-walled guiding sheath is available in a broad size range (4, 5, and 6F) with shaft lengths of 10 and 25 cm, as well as shaft lengths of 45, 70, and 90cm for 4 and 5F sizes. The device is suitable for distal peripheral intervention as well as for alternative approaches, such as tibiopedal or radial

Clinical News access sites.

“With Halo One thin-walled guiding sheath, we’re focusing on where those interventions begin, at the point of access. It effectively downsizes the access profile of peripheral procedures compared to standard sheaths, making it a valuable complement to our innovative portfolio of peripheral artery disease interventional devices,” said Steve Williamson, worldwide president of BD Peripheral Intervention.

“Access site complications occur in up to 11% of peripheral vascular interventions,” said JD Meler, vice president for medical and clinical affairs at BD. “A low profile guiding sheath that is available in lengths suitable for distal peripheral interventions and with a design that can help to reduce access site complications, which have been shown to increase hospital length of stay and costs, is a meaningful addition to our interventional suite of products.”

Surmodics receives CE mark for its SurVeil DCB

Surmodics recently announced it has received CE mark certification in the European Union for its SurVeil drugcoated balloon (DCB).

“I am excited about the potential of the SurVeil DCB to improve the treatment of PAD,” said Marianne Brodmann, interventional cardiologist at Medical University Graz (Graz, Austria) and a principal investigator of TRANSCEND, Surmodics’ pivotal clinical trial for the SurVeil DCB. “Drug-coated balloons have been widely utilised in Europe as a frontline treatment for PAD.” The SurVeil DCB, a next-generation device that utilises best-in-class technology in the treatment of peripheral arterial disease (PAD), includes a proprietary drug-excipient formulation for a durable balloon coating, and is manufactured using an innovative process to improve coating uniformity. Preclinical data have shown a more evenly distributed and durable drug effect, and lower incidence of downstream drug particles compared to the control DCB. “This CE mark is a critical milestone and an exciting step forward for Surmodics as we continue to demonstrate industry leadership in the development of pioneering vascular medical devices,” said Gary Maharaj, president and chief executive officer of Surmodics.

“The design of the SurVeil DCB reflects our dedication to providing innovative solutions that bring real clinical value—benefitting both clinicians and the patients that they treat.” In February 2018, Surmodics entered into an agreement with Abbott that provided Abbott with exclusive worldwide commercialisation rights for the SurVeil DCB.

Medtronic begins real-world, post-market study of Valiant Navion in patients with thoracic aortic dissection

Medtronic has announced the start of a prospective, observational, global, multicentre, real-world, post-market study to evaluate the safety and effectiveness of the Valiant Navion thoracic stent graft system in the treatment of thoracic aortic dissection.

The first patient procedure in the DISSECT-N study was performed at Northwell Health in New York, USA

by Derek Brinster, director of Aortic Surgery.

“Treatment of aortic dissection is often challenging, especially as patients with fragile aortas have different needs.

The Valiant Navion CoveredSeal configuration, designed with fragile aortic tissue in mind, can be especially helpful in treating this condition,” said Ross Milner, director of the Center for Aortic Diseases at the University of Chicago Medicine in Chicago, USA and US principal investigator for the DISSECT-N study. “I believe the DISSECT-N study—one of the larger prospective aortic dissection repair studies, which includes independent core-lab imaging review—will offer critical contemporary insights about TEVAR use in patients with various types of thoracic aortic dissection.”

The DISSECT-N study will enrol at least 200 patients with an acute or chronic thoracic aortic dissection across approximately 45 sites in North America, Europe, and Asia Pacific. The primary endpoint is composite safety and effectiveness, including technical procedure success and freedom from major adverse events (MAEs) reported up to one month following the index procedure. Patients will be followed for three years.

Positive two-year data from ALPS registry of LimFlow system published LimFlow SA has announced the publication of positive two-year data from the ALPS registry of the LimFlow percutaneous deep vein

LimFlow’s pDVA system

arterialisation (pDVA) system.

Results were published online in May in the Journal of Endovascular Therapy and will also appear in the August print issue of the journal.

The ALPS Registry is the largest study to date of no-option chronic limbthreatening ischaemia (CLTI) patients treated with the LimFlow system

reporting mid- and long-term results.

“In this complex group of patients, pDVA using the LimFlow device has shown to be feasible and safe with high technical success and good amputationfree survival at six months up to 24 months coupled with good wound healing,” said the paper’s lead author, Andrej Schmidt (Leipzig University Hospital, Leipzig, Germany). “In selected patients with no-option CLTI, pDVA is a safe and effective treatment to prevent amputation and heal wounds.”

“Patients with this disease suffer with chronic ulcers, often including gangrene, recurrent pain, and a very poor quality of life. CLTI is associated with poor mid- and long-term survival, and nooption patients often face the worst outcomes,” said Roberto Ferraresi, chief of the Peripheral Interventional Unit at the San Carlo Clinic, Milan, Italy, coauthor of the paper, and a pioneer in the interventional treatment of CLTI. “These patients desperately need an option to avoid amputation and improve their life, and LimFlow offers a very promising alternative for them.”

The ALPS registry is a multicentre, retrospective study conducted at centres in Alkmaar, the Netherlands; Leipzig, Germany; Paris, France; and Singapore, encompassing 32 end-stage—or “nooption”—CLTI patients. All patients had non-healing wounds on the target foot and no arterial target for surgical or endovascular revascularisation. Among them, 66% had diabetes, 53% had renal insufficiency, and 16% were dialysis dependent. The majority of patients had experienced failed prior attempts at revascularisation.

The registry reported major amputation-free survival of 84%, 71%, and 67%, respectively, at six months, one year, and two years. Additionally, a positive trend of successful wound healing was demonstrated, with 73% of wounds completely healed at two years.

Technical success was 97%.

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. For many patients, restoring perfusion in the lower limbs resolves chronic pain, improves quality of life, enables wound healing, and prevents major amputation.

“It is very gratifying to see these durable results being demonstrated by the LimFlow system in a real-world setting with consecutive patients,” said LimFlow CEO Dan Rose. “For these no-option patients, the next intervention for their leg was going to be major amputation, with the associated morbidity and high mortality risk that comes with amputation. Instead, two years later, the vast majority of patients are alive, with almost three-quarters of them experiencing completely healed wounds.”

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July 2020 | Issue 86

Market Watch

Industry News LeMaitre Vascular acquires Artegraft

LeMaitre Vascular recently announced that it has acquired the business and assets of Artegraft for US$90 million.

Under the terms of the deal, LeMaitre will continue to operate Artegraft’s manufacturing facility in North Brunswick, USA for at least three and a half years and will retain most of Artegraft’s employees, including seven sales and marketing personnel.

Artegraft processes and sells biologic vascular grafts that are derived from bovine carotid arteries and are implanted primarily in haemodialysis access patients. The products are marketed under the brand Artegraft and are sold only in the USA. Artegraft generated trade sales of US$15.6 million and estimated hospital-level sales of US$18.6 million during the twelvemonth period ended 31 May 2020.

Artegraft’s unit sales grew 10% in 2019.

Dave Roberts, LeMaitre Vascular’s president, commented, “We are pleased to add Artegraft to our product offering, augmenting the suite of biologic and dialysis access products used by our core customer, the vascular surgeon.

With this acquisition, we expect Artegraft to be the largest product line in our US sales bag and the cornerstone

of our offering of devices used to treat patients with end-stage renal disease.”

Rick Gibson, CEO of Artegraft, commented, “With their focus on haemodialysis access procedures, biologic implants, and the vascular surgeon, LeMaitre Vascular is ideally positioned to build on Artegraft’s success. We look forward to working with the LeMaitre team to ensure a smooth transition of the business.”

LeMaitre Vascular financed the acquisition and related expenses with available cash on hand and a US$65 million senior secured credit facility.

The credit facility comprises a US$40 million five-year term loan and a US$25 million revolver and was provided by KeyBank National Association and Truist Bank.

Rexgenero acquires the key technology and programme assets of aratinga.bio SAS Group

Rexgenero, a regenerative medicine company developing advanced cell therapies to treat chronic limbthreatening ischaemia (CLTI), has announced the acquisition of all the key assets of aratinga.bio SAS Group, a preclinical-stage immunotherapy biotechnology company based in Paris,

France.

The acquisition, which follows the recent approval by the French Commercial Court, includes all patent applications and related intellectual property, the exclusive license agreement for polymeric nanoparticle technology and the bioproduction facilities of aratinga.bio SAS Group, as well as the entire aratinga.bio team.

All assets of aratinga.bio SAS Group will be transferred to a newly-created French subsidiary of Rexgenero.

David Horn Solomon, chair of Rexgenero, comments: “The acquisition of the aratinga.bio SAS Group’s assets and intellectual property will enable the creation of an integrated cell and gene therapy platform that combines our innovative late-stage Phase III REX-001 programme for chronic limbthreatening ischaemia with aratinga.bio SAS Group’s potentially transformative in vivo CAR-T platform. In addition, the operating synergies between the two businesses are considerable.”

Renaud Vaillant, chief executive officer of aratinga.bio SAS Group, says: “This unique combination provides the solution we have been looking for, enabling us to continue the development of our breakthrough CAR-T technology to proof of concept in 2020 in preparation for a Phase I/II clinical trial.”

Cécile Bauche, chief scientific officer of aratinga.bio SAS Group, adds: “This acquisition will provide funding for experiments needed to demonstrate

proof of concept of our CAR-T therapeutics in vivo.”

The transaction enables aratinga.bio SAS Group to continue the development of its technology, and for the Paris-based team (15 people in Villejuif, close to the Institut Gustave Roussy) to pursue this programme.

BD acquires Straub Medical

Straub Medical was acquired by Becton, Dickinson and Company (BD) on 20 April 2020. Straub Medical manufactures, develops, and sells medical devices for the treatment of arterial and venous diseases.

Gido Karges, CEO of Straub Medical, comments: “BD is the ideal strategic addition to Straub Medical. With its complementary product portfolio and established global sales channels, BD offers treatment solutions for vascular specialists around the world to advance the world of health.”

“With our extensive expertise in endovascular technologies and our strong global infrastructure, BD is the right company to offer Straub Medical products worldwide as an important building block of our modern treatment solutions,” says Steve Williamson, president of BD’s Peripheral Intervention business.

Calendar of events 8–11 September CX Aortic Vienna Virtual event

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.

www.cxsymposium.com/ cxaortic

29 September–29 October ESVS Month Virtual event www.esvs.org

September

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2019 | Issue

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Institute N of the National guideline VERSIO THE DRAFT Care Excellence (NICE) on in and for consultati for Health when released that patients with ndation created a furore, be offered its recomme should only 2018, with d aneurysm able to undergo an unrupture if they were fit and providers open surgery, . Many surgeons, service guideline draft the procedure ers have called the n has been and stakehold and its publicatio “unimplementable” since then.

Board,” deferred the NICE repeatedly of the now sits with UK), president “The guideline (London, and Ireland Loftus Ian Britain says for Great nted. “There Vascular Societycalls this step unprecede re-wording who sides and (VSGBI), ise on both ,” he tells Vascular the must be comprom workable guidance closely with to make this that NICE is working .

News, noting progress the guideline onal Interventi ers to Society of stakehold in discussion the British VSGBI and together been of (BSIR) have cated the concerns of Radiology and communi a letter to members with NICE g ty. In challengin communi has been set the vascular writes: “It is no date VSGBI, Loftus and at present there with NICE, for all concernedWe remain in touch help to find a n. to our for publicatio reiterated our desire Conte interests of Michael about the fact that [...] and have is in the best “to recognise solution that did raise our concerns and tening workable Conte said, limb-threa NICE The He adds: “We constitutes this problem,” s, with both scenarios. patients.” practice, what of the guideline in different it.” in current suggests that to change the wording may be different limb ischaemia were unable ischaemia below which of critical BSIR, but is okay. value of perfusion previous concept everyone threshold which there is some and above the expanding is critical, 4 diabetes and on page everyone is that with Continued What we realised

16–17 October Critical Issues in Aortic Endografting Paris, France www.critical-issuescongress.com

2–5 November VIVA: Vascular Interventional Advances Las Vegas, USA www.vivaphysicians.org

25–27 November Vascular Societies’ Annual Scientific Meeting Brighton, UK

2021

www.vascularsociety.org.uk

26–29 January LINC – The Leipzig Interventional Course Leipzig, Germany

www.leipzig-interventionalcourse.com

23–27 February VEITHsymposium New York, USA

www.veithsymposium.org

7–9 March 24th European Vascular Course (EVC) Maastricht, the Netherlands www.vascular-course.com

2–5 June Society for Vascular Surgery (SVS) Vascular Annual Meeting San Diego, USA www.vascular.org

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