Vascular News 91 – September 2021 US Edition by BIBA Publishing

September 2021 | Issue 91

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Featured in this issue:

VOYAGER Santiago Garcia PAD & New Deepak research Bhatt presented Transcatheter at SVS mitral VAM valve2021 implantation

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Five-year ACST-2 results: Carotid artery surgery and stenting have similar longterm effects on stroke Carotid artery surgery and stenting have comparable long-term effects on fatal or disabling stroke in asymptomatic patients with severe carotid artery stenosis. That is the finding of late-breaking ACST-2 data presented in a Hot Line session at the European Society of Cardiology’s 2021 congress (ESC 2021; 27–30 August, virtual) and published simultaneously in The Lancet.

atients with severe carotid trial) is the largest study to date comparing the artery stenosis are at elevated long-term effect of CAS versus CEA on stroke in risk of stroke, and both carotid asymptomatic patients with a severely narrowed artery stenting (CAS) and carotid carotid artery that had not yet caused a stroke. endarterectomy (CEA) can restore However, Halliday et al see the study size as patency and reduce the long-term risk the chief limitation of the trial. They elaborate: of stroke. “This is the largest carotid intervention trial Writing in The Lancet, principal yet conducted, but still it must be considered investigator Alison Halliday (University together with all other trials of CAS versus The risk from of Oxford, Oxford, UK) and colleagues CEA.” each procedure detail that, in North America, some is about 1%. 100,000 surgery or stenting procedures Study details After that, are done each year to treat carotid The international, multicentre, randomised however, the artery narrowing, and numbers are ACST-2 trial enrolled patients with severe carotid annual risk over similar for Europe. About half are to artery narrowing found by chance, but with no the next five or prevent recurrent stroke in symptomatic recent stroke or other neurological symptoms. more years is patients and half are for primary stroke Participants were thought by their doctor to need halved, from 1% prevention in asymptomatic patients, CAS or CEA but both doctor and patient were down to 0.5% with the proportion varying from one substantially uncertain about which procedure per year country to another. “Successful CEA was preferable. approximately halves the long-term Between 15 January 2008 and 31 December risk among asymptomatic patients with 2020, a total of 3,625 patients were enrolled severe (e.g. 70–99%) stenosis,” the from 130 centres in 33 countries. Participants authors note. were randomly allocated 1:1 to CAS or CEA However, both CAS and CEA carry a short-term risk and followed up for an average of five years. The of stroke, which is about twice as great for symptomatic main outcomes were procedural risks (morbidity and as for asymptomatic patients. While the risks associated mortality within one month after the procedure) and, with carotid procedures used to be “substantial”, the most importantly, non-procedural stroke, subdivided by authors communicate, they have become lower over severity. the years. In fact, they reference nationwide registry data from Germany showing that, among asymptomatic patients, CAS and CEA are both associated with a risk of approximately 1% of disabling stroke or death. Comparative data are lacking on the long-term protective effects of the two carotid procedures. Halliday et al summarise the available data: “The evidence thus far from randomised trials of CAS versus CEA suggests appropriate similarity of the long-term protective effects of the two procedures, but it has involved only limited numbers of asymptomatic patients.” The ACST-2 trial, with a larger number of participants, aimed to provide more robust comparisons of the long-term protective effects of CAS versus CEA. ACST-2 (the second asymptomatic carotid surgery Continued on page 4

ACST-2 is the world’s largest randomised trial of carotid procedures to date, representing the work of many surgeons, radiologists and stroke doctors.”

Profile:Profile: VinodJoseph Thourani E Medicine Bavaria in modern pagetimes 20 page 00

Amputation rates higher for people with PAD who are poor or Black; other health gaps noted in special issue Poverty and Black race were associated with higher rates of lower leg amputation among people with peripheral arterial disease (PAD) who live in metropolitan areas, according to new research published in a special issue of the Journal of the American Heart Association (JAHA), an open access journal of the American Heart Association (AHA). THE ANALYSIS ON PAD-RELATED amputations is one of 16 new research studies highlighting health disparities among people from diverse population groups and published in the special spotlight issue of JAHA. JAHA senior associate editor Pamela Peterson (University of Colorado Denver, Denver, USA) and associate editor Sula Mazimba (University of Virginia Health System, Charlottesville, USA) note that while management of cardiovascular disease has reduced death rates over time, there are still “striking disparities” in the USA that have widened along racial, ethnic, socioeconomic and geographical lines. “We hope that this issue of JAHA will reinforce the recent AHA’s presidential advisory statement urging all stakeholders to a committed path towards transforming the conditions of historically marginalised communities, improving the quality of housing and neighbourhood environments of these populations, advocating for policies that eliminate inequities in access to economic opportunities, quality education and healthcare, and enhancing allyship among racial and ethnic groups,” they write. The study, “Geographic and socioeconomic disparities in major lower extremity amputation rates in metropolitan areas”, by Alexander Fanaroff (University of Pennsylvania, Philadelphia, USA) et al, is an analysis of national Medicare claims Continued on page 6

September 2021 | Issue 91

Top Stories

Amputation rates higher for people with PAD who are poor or Black; other health gaps noted in special issue Continued from page 1

data to determine ZIP code-level variation in rates of amputation among Medicare beneficiaries. “Limb amputation can be delayed and/or prevented by timely and aggressive treatment. However, lack of access to specialised care may delay PAD diagnosis and limit efforts to save the limbs if it has progressed to the advanced disease stage,” explained Fanaroff. Fanaroff and colleagues found that ZIP codes with a higher proportion of Black residents had higher amputation rates than ZIP codes with lower proportions of Black residents. In addition, ZIP codes with lower median household income, more residents eligible for Medicaid, and worse scores on the Distressed Communities Index scale (a composite marker of socioeconomic status), had higher amputation rates compared to ZIP codes with higher socioeconomic status, even after adjusting for clinical and demographic characteristics. “Though amputation rates are generally higher in rural areas, this finding shows that the association between lower socioeconomic status, race and amputation rate extends to major metropolitan areas as well as rural regions,” Fanaroff said. “We found that closer proximity to specialised PAD care within metropolitan areas does not ensure access to highquality care. Strategies targeted to communities with high amputation rates are also needed in urban areas to reduce these disparities.” A recent AHA scientific statement noted sex and ethnic disparities exist in the diagnosis and treatment of the most severe form of PAD, chronic limb-threatening ischaemia (CLTI). Another article in the spotlight issue is a retrospective study of more than 425,000 women (ages 12–49; 59% non-Hispanic white women, 31% non-

Limb amputation can be delayed and/ or prevented by timely and aggressive treatment. However, lack of access to specialised care may delay PAD diagnosis and limit efforts to save the limbs if it has progressed to the advanced disease stage.” Hispanic Black women and 10% Hispanic women) in South Carolina who gave birth from 2004–2016 and

CardioVascular Coalition urges Congress, CMS to reverse proposed Medicare cuts during PAD Awareness Month The CardioVascular Coalition (CVC), a coalition of physicians, care providers, advocates, and manufacturers working to improve awareness and prevention of peripheral arterial disease (PAD), has called on the US Congress and the Centers for Medicare & Medicaid Services (CMS) to address severe proposed cuts to speciality provider services in order to help increase access to care.

MS recently proposed cutting payments for revascularisation services by approximately 23% in the proposed Physician Fee Schedule (PFS) Rule for the calendar year 2022. The proposed cuts, which are being driven by a provision that purports to update clinical labour data, would have a severe impact on cardiology, vascular surgery, venous, radiation oncology, and radiology practices. Though outpatient health

services—including revascularisation— are cost-effective and convenient for patients, the proposed cuts would have profoundly negative effects on patient access and health equity. If the proposed cuts are finalised as currently proposed, Medicare beneficiaries will face more serious risks of limb loss. “As we recognise PAD Awareness Month and the major impact that PAD has on Americans—particularly people of colour—I am deeply troubled by CMS’

were followed through 2017. The study, “Incident heart failure within the first and fifth year of delivery among women with hypertensive disorders of pregnancy and pre-pregnancy hypertension in a diverse population”, by Angela M Malek (Medical University of South Carolina, Charleston, USA) et al, found racial and ethnic differences in heart failure rates among women who experience hypertensive disorders during pregnancy as well as among women who experience hypertensive disorders both before and during pregnancy. Non-Hispanic Black women who had hypertensive disorders of pregnancy with and without pre-pregnancy hypertension had a higher incident heart failure risk within five years of giving birth compared to non-Hispanic white women without hypertension (before or during pregnancy). Among women who had pre-eclampsia or other hypertensive disorders during pregnancy, heart failure event rates were substantially higher in non-Hispanic Black women than non-Hispanic white women: 2.28 compared to 0.96 per 1,000 person-years, respectively. In women who had hypertensive disorders of pregnancy with prepregnancy hypertension, heart failure event rates were also substantially higher among non-Hispanic Black women than non-Hispanic white women: 4.3 compared to 1.22 per 1,000 person-years, respectively. “These racial and ethnic differences are important since we already know non-Hispanic Black women experience higher pregnancy-related deaths than nonHispanic white women,” said Malek. “Clinical and public health prevention efforts are needed to reduce complications and death rates in women who have hypertensive disorders before or during pregnancy, as they are at increased risk of heart failure or dying from heart failure within five years.” Additional research is needed to examine further racial/ethnic differences in maternal incident heart failure after delivery. The clinical and public health implications of this research could inform changes to clinical practice to reduce modifiable cardiovascular risk factors and screening for adverse maternal outcomes in women identified as high risk, according to the study. Other research featured in the JAHA spotlight issue on health disparities can be accessed in full at www. ahajournals.org/jaha/spotlight_disparities.

flawed proposal to cut vital services like revascularisation by as much as 23%,” said CVC Board member Jeff Carr (Tyler Cardiac and Endovascular Center, Tyler, USA). “At a time when America is suffering a PAD and amputation crisis on top of the COVID-19 pandemic, it is absolutely critical to ensure patients’ continued access to the services that are proven to help prevent amputations and slow disease progression. Unless Congress and CMS act to address these proposed cuts, I fear that it will be harder for patients to access necessary care, resulting in even more amputations, worse outcomes, and even greater healthcare disparities.” According to estimates, PAD affects nearly 20 million Americans and is responsible for 80% of the 200,000 non-traumatic limb amputations that take place in the USA each year. These non-traumatic amputations often occur without any diagnostic testing, meaning

PAD patients are losing limbs before they receive testing to determine if limbsaving interventions are an option. PAD is exacerbated by conditions like diabetes, chronic hypertension, and renal disease, which are most prevalent in minority populations. Access to revascularisation therapies is especially vital to the African American, Hispanic, and Native American populations who are two-to-four times more likely to undergo a limb amputation due to PAD because of the increased prevalence of diabetes, obesity, and other risk factors. “To address the issues of patient access and systemic health inequity in our country, CMS must reverse course and not finalise the clinical labour policy in the 2022 PFS Proposed Rule,” continued Carr. “Further, CMS should work closely with Congress to fundamentally reform the Physician Fee Schedule so that any future unjustified cuts to speciality provider services can be avoided.”

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Issue 91 | September 2021

Guidelines

SVS

SVS releases updated clinical practice guidelines on extracranial cerebrovascular disease The Society for Vascular Surgery (SVS) has released updated clinical practice guidelines accompanied by an implementation document on the management of patients with extracranial carotid artery disease. The documents, both published in the Journal of Vascular Surgery, aim to use the existing clinical evidence to ensure patients with atherosclerotic occlusive disease in the carotid arteries receive appropriate treatment and care.

ince the SVS issued its previous update of the clinical practice guidelines for carotid artery disease in 2011, several pivotal studies comparing carotid endarterectomy (CEA) and carotid artery stenting (CAS) have been published. In addition, the literature has demonstrated a confirmation of the need for optimisation of medical therapy. Therefore, the updated SVS guidelines provide graded recommendations that address five questions: 1) Is carotid endarterectomy recommended over maximal medical therapy for asymptomatic carotid stenosis in low surgical risk patients?

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2) Is carotid endarterectomy recommended over transfemoral carotid artery stenting in low surgical risk patients for symptomatic carotid artery stenosis of >50%? 3) What is the optimal timing of carotid intervention in patients presenting with acute stroke? 4) What is the best screening protocol for carotid artery stenosis in asymptomatic patients? 5) What is the optimal sequence for intervention in patients with combined carotid and coronary artery disease?

Recommendations at a glance

According to Ali AbuRahma (West Virginia UniversityCharleston Division, Charleston, USA), chair of the writing group, “These guideline recommendations address the latest technology in the management of carotid disease, such as transcarotid artery stenting with flow reversal and how its outcomes compare to transfemoral stenting and the gold standard, CEA.” • The committee recommends CEA as the first-line treatment for symptomatic low surgical risk patients with stenosis of 50–99% and asymptomatic patients with stenosis of 70–99%. The perioperative risk of stroke and death must be <3% to ensure benefit for the patient. • In patients with recent stable stroke (modified Rankin 0–2), carotid revascularisation is considered appropriate in symptomatic patients with greater than 50% stenosis and is recommended and performed as soon as the patient is neurologically stable after 48 hours but definitely before 14 days of onset of symptoms. • In the general population, screening for clinically asymptomatic carotid artery stenosis in patients without cerebrovascular symptoms of significant risk factors for carotid Ali artery disease is AbuRahma

not recommended. • In selected asymptomatic patients who are at increased risk for carotid stenosis, screening is recommended for clinically asymptomatic carotid artery stenosis as long as the patients would potentially be fit for and willing to consider carotid intervention if significant stenosis is discovered. • In patients with symptomatic carotid stenosis 50–99%, who require both CEA and coronary artery bypass graft (CABG), the committee suggests CEA before or concomitant with CABG to potentially reduce the risk of stroke and stroke/death. The

These guideline recommendations address the latest technology in the management of carotid disease, such as transcarotid artery stenting with flow reversal and how its outcomes compare to transfemoral stenting and the gold standard, CEA.” sequencing of the intervention depends on clinical presentation and institutional experience. The writing group, composed of experts in carotid artery disease, also identified additional topics that needed to be addressed more thoroughly. A separate implementation document includes details on some of these topics, including therapeutic decision-making, perioperative management, medical therapy, other cerebrovascular conditions, and practice management. It is intended to make the guidelines more practical and helpful to clinicians, and provides implementation details to facilitate adoption and operationalisation of the guideline recommendations. “The advantage of

two documents is having quick access to evidencebased recommendations in the clinical practice guideline, while also having the implementation document, which comprehensively addresses every aspect of the management of carotid disease and stroke prevention,” says AbuRahma.

ACST-2 results “complement and reinforce” guidelines

Five-year ACST-2 results, showing that carotid artery surgery and stenting have similar long-term effects on stroke, have been revealed since the guidelines were published. Speaking to Vascular News, writing group member Efthymios D Avgerinos (University of Pittsburgh School of Medicine, Pittsburgh, USA) comments: “The long-anticipated results of ACST-2 complement and reinforce the recently published SVS guidelines implementation document. “ACST-2 confirmed the lowest to-date in-trial perioperative (~1%) and annual (~0.5%) stroke rates (disabling or fatal) after a carotid intervention for asymptomatic disease, and they were similar for both CEA and CAS. Still, minor perioperative strokes (and their unclear long-term implication) were slightly higher with CAS. “This is with the understanding that CAS (and CEA) operators are competent enough to achieve such a low perioperative event rate and best medical treatment can be aggressively implemented. As always, concern exists whether data from such randomised controlled trials can be extrapolated to real-world experience. “As with the CREST and ACT studies, ACST2 suggests and reinforces that in properly selected asymptomatic patients, CAS is probably equivalent to CEA in the hands of experienced interventionalists and should be considered for reduction of the long-term risk of stroke in patients with good life expectancy. Stepping on the ACST-2 results, transfemoral CAS seems to gain favourable evidence towards a firstline treatment; still, collective data is insufficient to recommend it as a primary therapy equivalent to CEA. This is in full agreement with the 2021 SVS guidelines.” (See page 1 for a full report of the ACST-2 five-year results.) Alongside AbuRahma and Avgerinos, the SVS guidelines writing group included Robert W Chang (Permanente Medical Group, San Francisco, USA), R Clement Darling, III (Albany Med Vascular, Albany, USA), Audra A Duncan (University of Western Ontario, London, Canada), Thomas L Forbes (University of Western Ontario), Mahmoud B Malas (University of California San Diego, La Jolla, USA), Bruce Alan Perler (Johns Hopkins, Baltimore, USA), Richard J Powell (Dartmouth-Hitchcock, Lebanon, USA), Caron B Rockman (New York University Langone, New York, USA), and Wei Zhou (University of Arizona, Tucson, USA).

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RESULTS CryoLife, Inc. 1655 Roberts Boulevard, NW, Kennesaw, Georgia 30144 USA Phone: 888-427-9654 Fax: 770-590-3753 Email: CUSTSVC@cryolife.com www.CryoLife.com All registered trademarks are owned by CryoLife, Inc. © 2020 CryoLife, Inc. All rights reserved. MLENG1392.000 (2020-01)

Issue 91 | September 2021

New Data

SVS

cohort was 65 (59–70) compared to 66 (61–72) in the prosthetic group, and that the number of female patients in the venous group was slightly lower than in the prosthetic group, at 17 and 22, respectively. Medical comorbidities were not different between the two groups, he added. With regard to distribution by target artery, Govsyeyev stated that venous conduits were more “A strategy of adding rivaroxaban 2.5mg twice daily to aspirin should be considered likely to be used below the knee, whereas three quarters after lower extremity bypass regardless of conduit type,” concluded Nicholas Govsyeyev of prosthetic conduits had an above-the-knee target (University of Colorado, Aurora, USA) during the William J von Liebig Forum at the artery. Society for Vascular Surgery’s Vascular Annual Meeting (SVS VAM 2021; 18–21 August, Govsyeyev reported that, in the placebo group, San Diego, USA and online). Govsyeyev was giving an update on the VOYAGER PAD trial, the cumulative incidence of unplanned limb addressing the efficacy of rivaroxaban and aspirin in peripheral arterial disease (PAD) revascularisation at three years from randomisation patients with venous and prosthetic surgical bypass conduits. was 29.6% in the prosthetic cohort (n=388) compared to 13.1% in the venous cohort (n=314), with a risk “THE OPTIMAL ANTITHROMBOTIC reduced by 19% with rivaroxaban.” difference of 16.5%. Regarding acute limb ischaemia, therapy following infrainguinal bypass is not known,” The objectives of the current study, Govsyeyev the figures were 13.6% and 5.4%, respectively, with an Govsyeyev began. He noted that two major trials have explained, were to compare limb outcomes with venous 8.2% risk difference. examined the role of dual antiplatelet therapy (DAPT) versus prosthetic conduits in VOYAGER PAD patients The presenter then outlined results related to the and oral anticoagulation following infrainguinal who underwent bypass, and to evaluate whether the efficacy of rivaroxaban on the primary composite bypass—CASPAR and DUTCH BOA. While both efficacy of rivaroxaban is consistent across conduit endpoint by conduit type. “Prosthetic patients were these trials had neutral results, the presenter detailed, types. at higher risk for primary endpoint events, and this there was significant heterogeneity by conduit type, In order to assess this goal, the researchers used a was reduced with rivaroxaban, with an absolute risk with the CASPAR trial showing the potential benefit multivariate adjusted model to determine the risk of difference of 6.4%,” Govsyeyev revealed. Among of DAPT in prosthetic conduits and the the venous conduits, the data showed DUTCH BOA trial demonstrating the an absolute risk difference of 7.9% with potential benefit of anticoagulation in rivaroxaban. Govsyeyev added that there was venous conduits. Both trials, however, had a no significant interaction by conduit type significant increase in major bleeding. and overall bleeding was quite low in the “The VOYAGER PAD trial provides rivaroxaban and placebo groups. a large, prospective database to further Furthermore, the speaker informed examine the optimal antithrombotic regimen the audience that there was consistent following infrainguinal bypass,” Govsyeyev benefit of rivaroxaban on limb outcomes remarked. This trial randomised 6,554 regardless of conduit type. He summarised patients with symptomatic PAD undergoing the results: “Prosthetic conduits had a lower extremity revascularisation and higher risk for limb outcomes; acute limb receiving standard of care to rivaroxaban ischaemia was reduced in both venous and 2.5mg taken twice daily or placebo, with prosthetic conduits with rivaroxaban, with Nicholas Govsyeyev presents new VOYAGER PAD data at SVS VAM 2021 standard of care consisting of aspirin, a particularly strong benefit among venous clopidogrel use per the investigator’s conduits with a greater than 50% reduction; discretion, and the encouragement of statin use. limb outcomes in patients with venous and prosthetic major amputation was reduced in venous conduits but Govsyeyev summarised the key findings: “The conduits, and Cox proportional hazards to assess for not in prosthetic; unplanned limb revascularisation trial demonstrated a 15% reduction in the primary efficacy. was reduced in prosthetic but not in venous; and there composite endpoint of acute limb ischaemia, major Govsyeyev detailed that a total of 1,448 patients was no significant interaction for any limb outcome by amputation, myocardial infarction, ischaemic stroke, (66%) underwent bypass in the VOYAGER trial. conduit type.” and cardiovascular death; bleeding was increased, but Breaking this down by conduit type, he noted that Addressing the VAM audience, Govsyeyev overall incidence was low with rivaroxaban; there was prosthetic use was slightly more frequent (773 patients; concluded that a strategy of rivaroxaban 2.5mg twice no significant interaction for efficacy or safety on the 54%) than venous use (646 patients; 46%). daily reduces irreversible harm events and increases basis of surgical or endovascular revascularisation; and In terms of baseline characteristics, the speaker bleeding with a 6:1 benefit risk ratio, and that the surgical patients’ risk for primary endpoint events was communicated that the median age of the venous magnitude of benefit appears robust in surgical patients.

VOYAGER PAD: Rivaroxaban plus aspirin should be considered after lower extremity bypass regardless of conduit type

First ever analysis of TCAR in standard surgical risk patients demonstrates clinical benefits in large comparative dataset Silk Road Medical has announced positive results from an independent analysis of standard surgical risk patients undergoing carotid endarterectomy (CEA) and transcarotid artery revascularisation (TCAR) for atherosclerotic carotid disease. The analysis was presented at the Society for Vascular Surgery’s Vascular Annual Meeting (SVS VAM 2021; 18–21 August, San Diego, USA and online) and, according to Silk Road Medical, is the first ever presentation of outcomes for TCAR in standard surgical risk patients. MORE THAN 20,000 STANDARD surgical risk patients were included in the analysis (15,198 CEA and 5,066 TCAR) from the Vascular Quality Initiative (VQI) CEA and carotid artery stent (CAS) registries over four years

(August 2016 to September 2020). The results for symptomatic and asymptomatic standard surgical risk patients undergoing CEA and TCAR for atherosclerotic carotid disease showed that TCAR had statistically equivalent

stroke and death outcomes to CEA, while showing a nine-fold reduction in cranial nerve injury (2.7% vs. 0.3%, p=<0.001). “The promise of safely preventing stroke while delivering benefits from a less-invasive approach is critically important as we consider an expanded patient population. This first ever largescale, standard surgical risk analysis demonstrates that TCAR delivers on that promise,” said Erica Rogers, president and chief executive officer of Silk Road Medical. “These results reinforce the effectiveness of TCAR as an important treatment option for patients with carotid artery disease and standard surgical risk factors,” said Marc L Schermerhorn, chief, Division of Vascular and Endovascular Surgery at Beth Israel Deaconess Medical Center in Boston, USA. “TCAR again shows equivalent risk to CEA of perioperative stroke,

death, or myocardial infarction and ipsilateral stroke at one year in patients undergoing carotid revascularisation with improved secondary outcomes such as cranial nerve injury.”

These results reinforce the effectiveness of TCAR as an important treatment option for patients with carotid artery disease and standard surgical risk factors.”

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The AVeNEW Clinical Study was a prospective, multi-center, randomized, concurrently-controlled clinical study of the Covera™ Vascular Covered Stent in the treatment of stenosis in the venous outflow of the AV fistula access circuits. 280 patients were treated with the Covera Vascular Covered Stent at 24 investigational sites in the US, Europe, Australia and New Zealand. Patients were distributed globally with at least 50-75% being treated in the US. Target Lesion Primary Patency (TLPP) of 78.7% vs. 47.9% with PTA alone was defined as the interval following the index intervention until the next clinically-driven reintervention at or adjacent to the original treatment site or until the extremity was abandoned for permanent access. AVeNEW Clinical Study. Data on File. Bard Peripheral Vascular Inc., Tempe AZ

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Issue 91 | September 2021

New Data 13

SVS

Five-year STABLE II results show Zenith system makes the cut for acute complicated TBAD treatment Joseph V Lombardi (Cooper University Hospital, Camden, USA) reported long-term outcomes favouring the continued safety and effectiveness of a composite device (proximal covered stent graft plus distal bare stent) deployed for the endovascular repair of acute, type B aortic dissection (TBAD) complicated by aortic rupture and/or malperfusion.

“S

TABLE II results place freedom from all-cause mortality at 80.3% at one year, and 68.9% at five years [with the use of the Zenith dissection endovascular system from Cook Medical]. Further, there were two procedure-related deaths, and the freedom from dissection-related mortality remained 97.1% at one year through five years,” he told delegates of the Society for Vascular Surgery’s Vascular Annual Meeting (SVS VAM 2021; 18–21 August, San Diego, USA and online). The Zenith endovascular system includes a proximal covered stent graft to cover the primary entry tear plus a distal bare metal stent, built on a nitinol Z-stent platform, for true lumen support. The bare metal component provides expansible support along the length of the dissected aorta without blocking critical branch vessels to provide a scaffolding to aid adjunctive interventions and facilitate favourable aortic remodelling of the entire dissected aorta.

covered stent-graft plus distal bare stent, 79.5%) or the proximal stent graft alone (no distal bare stent, 20.5%). Dissections were more extensive in patients receiving the composite device (408.9±121.3mm long, with 47.4% of dissections extending into the iliac arteries) compared with those who did not receive the distal bare stent (315.9±100.1mm long, with 6.7% of dissections extending into the iliac arteries). Five-year follow-up was available for 86.1% of eligible patients.

False lumen thrombosis and the composite device

The researchers also communicated that proximal dissection events were reported in seven patients, including four patients with retrograde progression of dissection and three patients with a new tear/type A dissection. Outlining the adverse events Importantly, Lombardi called seen in the study, Lombardi out the progressive false lumen commented that notable adverse thrombosis seen within the stent events at one year were one graft region and the dissected instance of aortic rupture, one stent region. “Complete false instance of conversion to open lumen thrombosis rate increased repair and two instances of (75% of patients at five years vs. Joseph V stroke—there were no instances Lombardi 51.4% post-procedure), with a of paraplegia or paraparesis. higher complete thrombosis rate “Freedom from secondary intervention at five years in patients who received the was 88.2% in one year, and 70.7% at composite device (81%) compared with five years and secondary interventions the rate in patients who did not receive were used to treat a number of the distal bare stent (57.1%). presentations, including distal aortic “There were no incidences of growth. Aortic growth distal to the stent device fracture or infolding reported graft suggests the need for continuous and these five-year data suggest a monitoring,” he added. positive influence of composite device STABLE II is a prospective, singleuse on false lumen thrombosis,” he arm, multicentre study that enrolled summarised. 73 patients between August 2012 and January 2015 at institutions in the USA Bare metal stent necessities and Japan. The mean age of patients To a question posed on how the decision was 60.7 years with nearly 66% being was made to deploy or not deploy the male with acute TBAD complicated bare metal stent, Lombardi clarified: by malperfusion (78.1%), rupture “We left that up to our investigators (27.4%). Patients were treated with to determine the need for additional either a composite device (proximal stenting using the bare metal stent. A

Five-year results of the Gore Excluder IBE pivotal study confirm safety, efficacy and durability W L Gore & Associates (Gore) has announced that five-year results from the US prospective, multicentre study (n=63) evaluating endovascular repair of iliac aneurysms using the Gore Excluder iliac branch endoprosthesis (IBE) were presented at the Society for Vascular Surgery’s Vascular Annual Meeting (SVS VAM 2021; 18–21 August, San Diego, USA and online). Results of the study confirmed the safety, efficacy, and durability of the IBE for treatment of aortoiliac and iliac artery aneurysms.

THE GORE EXCLUDER IBE WAS APPROVED by the US Food & Drug Administration (FDA) in February 2016. According to a press release, it was the first off-the-shelf aortic branch device approved in the USA and remains the only device indicated for the endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms. Five-year primary patency of the internal iliac artery and external iliac artery IBE limbs was 95.1% and 100%, respectively. Furthermore, no patients experienced new onset buttock claudication on the IBE side or new onset erectile dysfunction. Additionally, there were no type I or type III endoleaks and no device migrations identified by the core lab, and freedom from secondary intervention was 88.2%. The device offers a treatment option that allows patients the benefits of endovascular therapy yet preserves pelvic perfusion. “The positive outcomes from Gore Excluder this five-year study validate the iliac branch effectiveness and durability of endoprosthesis the Gore Excluder IBE for the treatment of iliac artery aneurysms,” said Darren B Schneider (Penn Medicine and the University of

lot of the dissections were very focal on the thoracic aorta and some thought that an additional dissection stent was not needed to support normal aorta distally. So, this was a primary reason why dissection stents were not deployed, but the fact that we did not have dissection stents in a small cohort of patients gave us a nice control group to look at afterwards. When pressed on recommendations regarding when to use the dissection stent and tips on how far to place it, especially when the dissection was particularly distal, Lombardi explained: “The data is very supportive of the distal aortic remodelling using the dissection stent. And oftentimes, as you saw in the data, secondary interventions are not infrequent, and we will have to go back and reintervene for distal aortic growth

STABLE II results place freedom from allcause mortality at 80.3% at one year, and 68.9% at five years [with the use of the Zenith dissection endovascular system from Cook Medical].” to remedy ongoing expansion. The use of the dissection stent in that situation, for me and for a lot of our colleagues, has been very, very helpful in mitigating a continued false lumen flow. So, I am a believer in using it in all settings, as long as I am putting it across dissected aorta.”

Pennsylvania School of Medicine, Philadelphia, USA), the study’s national principal investigator. “Importantly, the IBE reduces the risk of common iliac artery enlargement and rupture while maintaining patency of the internal iliac artery to prevent complications associated with internal iliac artery sacrifice.” Used in conjunction with the Gore Excluder abdominal aortic aneurysm (AAA) endoprosthesis, the IBE isolates the common iliac artery from systemic blood flow and preserves blood flow in the external iliac and internal iliac arteries. Its design allows for a two-staged repositionable deployment for precise placement and has a precannulated internal iliac gate and bi-femoral delivery for ease of use.

Five-year primary patency of the internal iliac artery and external iliac artery IBE limbs was 95.1% and 100%, respectively.”

September 2021 | Issue 91

14 CX Aortic Vienna

Cardiac, vascular and endovascular leaders convene for CX Aortic Vienna Capturing the latest developments in the comprehensive treatment of aortic disease—from the aortic valve to the iliac arteries—CX Aortic Vienna returns for three days of CMEaccredited discussion and debate, bringing together the cardiac, vascular and endovascular worlds. With a live programme running from 5–7 October 2021, the meeting will showcase the latest approaches, open and endovascular, for the treatment of complex aortic problems.

X Aortic Vienna 2021 will be broadcast live online and available on-demand, with CX Aortic Vienna 2021 Vascular Endovascular and Cardiothoracic Executive Board members presenting from London, UK, and serving as expert moderators to generate exciting live audience discussion from around the world. Over five hours of CME content is available on each of the three days of broadcasting. “CX Aortic Vienna will begin at the top with the arch of the aorta. We ask ourselves: ‘What is the best way to treat aortic disease today?’” explains CX Aortic Vienna’s founding chair Roger Greenhalgh (London, UK). “In order to answer that we must involve cardiac surgeons, vascular surgeons and endovascular specialists, and then we shall work out how the patients should be best treated, debate it and discuss it. What we shall be considering at CX Aortic Vienna is every way in which the aorta can be managed—from the aortic valve to the iliac arteries.” The three days of education, innovation and evidence are brought to you with the participation of the Austrian Society of Vascular Surgery (ÖGG), the Swiss Society for Vascular Surgery (SGG), the German Society of Vascular Surgery (DGG), the Italian Society of Vascular and Endovascular Surgery (SICVE), the French Society

for Vascular and Endovascular Surgery (SCVE), and Aortic Surgery “How To Do It” (HTDI). The format will follow the CX style of short talks, debates, and audience interaction, presented live via broadcast, with five hours of CME programme on each day. The programme includes open and endovascular aortic techniques and technologies, including live and edited aortic cases, as well as industrial and networking satellite programmes spliced between CME sessions.

Day one:

Tuesday 5 October—features aortic arch challenges, with an opening session focusing on the frozen elephant trunk (FET) technique, asking whether the procedure continues to play an important role in the treatment of complex pathologies of the aortic arch. During the session, attendees will hear from expert speakers including Luca Bertoglio (Milan, Italy) who will discuss open or endovascular treatment of downstream thoracic or thoracoabdominal aortic pathology after FET, see edited cases from Gustavo Oderich (Houston, USA) and Tilo Kölbel (Hamburg, Germany), and learn about an optimised coagulation regime in contemporary FET surgery from Heinz Jakob (Essen, Germany). In a session dedicated to transcatheter aortic valve implantation (TAVI) and

paediatric cardiac aortic challenges, edited cases from David Holzhey (Leipzig, Germany) and Frank Arko (Charlotte, USA) document TAVI device deployment, and the benefits of thoracic stent grafts to see the positive remodeling of the aorta in patients with coarctation, respectively. Attendees will also gain insights from Michael Andrew Borger (Leipzig, Germany) on extraanatomic ascending-to-descending aortic bypass for patient with recurrent isthmus stenosis. Experts will also consider juxtarenal aortic neck challenges, with Giovanni Pratesi (Genoa, Italy) presenting an edited case detailing treatment of wide neck abdominal aortic aneurysms (AAAs) with enhanced proximal seal (ESAR) and Luca Bertoglio (Milan, Italy) discussing endovascular treatment of visceral aneurysm patch after previous thoracoabdominal aortic aneurysm (TAAA).

Day two:

Wednesday 6 October— the programme features a session on TAAA reconstruction and How To Do It (HTDI) from Roberto Chiesa (Milan, Italy) and his team. Among them, Daniel Mascia will detail TAAA standard open repair, Enrico Rinaldi will discuss recent advancements in TAAA open repair and organ protection, Andrea Kahlberg will offer tips and tricks in open conversion after thoracic endovascular aortic repair (TEVAR) or FET, and Luca Bertoglio will detail endovascular management of late complications of open TAAA repair,

CX Aortic Vienna will begin at the top with the arch of the aorta. We ask ourselves: What is the best way to treat aortic disease today?”

including intercostal and visceral patch aneurysm. Further focus on TAAA reconstruction on day two includes a podium first presentation from Dittmar Böckler (Heidelberg, Germany), a systematic review of migration in TEVAR, discussion of the durable long-term performance of a single TEVAR stent graft platform in multiple pathologies of the descending thoracic aorta from Joseph Bavaria (Philadelphia, USA), and outcomes of 3,677 TAAA open cases performed between 1986–2021, presented by Joseph Coselli (Houston, USA). Attendees will also hear the latest in radiation reduction challenges, including an edited case involving fenestrated EVAR using Fiber Optic RealShape (FORS) laser light guidance (Philips) from Kölbel, and discussion of dynamic computed tomography (CT) and magnetic resonance (MR) gold standards for aortic imaging from Alan Lumsden (Houston, USA). EVAR durability is also in the spotlight on day two of CX Aortic Vienna, with speakers touching on important current debates. Among them, Ian Loftus (London, UK) will detail 10year outcomes from aneurysm screening in South West London supporting an endovascular-first strategy, while Michael Stoner (Rochester Hills, USA) will consider the effect of aortic stent graft engineering on aortic sac regression after EVAR.

Final day:

Thursday 7 October—considers the importance of training and teamwork for optimal aortic patient outcomes. Eric Roselli (Cleveland, USA) will discuss the future training of aortic surgeons, while Bavaria lays out the importance of a multidisciplinary thoracic aortic team. Michael Jacobs (Maastricht, The Netherlands) will also set out the arguments and evidence to centralise complex open and endovascular aortic procedures. The three-day event will close with a series of best of abstract sessions, featuring abstracts from the Austrian, German and Swiss societies.

The speakers:

Left to right: Joseph Bavaria Dittmar Böckler Roberto Chiesa Joseph Coselli Gustavo Oderich

Issue 91 | September 2021

CX Aortic Vienna 15

Aortic Event

CX Aortic Vienna 2021 programme Bringing together the cardiac aortic, vascular and endovascular worlds, CX Aortic Vienna 2021, spanning the aortic valve to the iliac arteries. Broadcast globally, the CME-accredited meeting runs from 5 to 7 October. Register now at cxsymposium.com/cxaortic/cx-aortic-vienna/registration/. Day 1:

Day 2:

Day 3:

Tuesday 5th October

Wednesday 6th October

Thursday 7th October

Time: 11:00–18:00 London time (BST)

CX Aortic arch challenges. Is Frozen Elephant Trunk (FET) still needed? Time: 11:00–12:00 London time (BST)

Thoraco-Abdominal Aortic Aneurysm (TAAA) Reconstruction & How To Do It (HTDI) Professor Roberto Chiesa and team Time: 11:00–12:00 London time (BST)

Training & Teamwork for Optimal Aortic Patient Outcomes Time: 11:00–12:00 London time (BST)

Best of CX and Prize abstracts Time: 12:00–12:30 London time (BST) CX Aortic arch challenges. Is Frozen Elephant Trunk (FET) still needed? (continued) Time: 12:30–12:50 London time (BST) TAVI & CX Paediatric Cardiac Aortic Challenges Time: 12:50–13:30 London time (BST) Best of CX and Prize abstracts Time: 13:30–14:00 London time (BST) CX Juxtarenal Aortic Neck Challenges Time: 14:00–15:00 London time (BST) Industry Satellite: How to approach safely complex AAA with off-the-shelf solutions Time: 15:00–15:30 London time (BST) CX Arch Aortic Stroke from Thoracic Endovascular Procedures (STEP) Time: 15:30–16:20 London time (BST)

Best of CX and Prize abstracts Time: 12:00–12:30 London time (BST) Thoraco-Abdominal Aortic Aneurysm (TAAA) Reconstruction (continued) Time: 12:30–13:30 London time (BST) Industry Satellite: Five years of proven durability with Zenith Alpha thoracic Low-profile system Time: 13:30–14:00 London time (BST) Thoraco-Abdominal Aortic Aneurysm (TAAA) Reconstruction (continued) Time: 14:00–14:40 London time (BST) Reduction of Radiation Challenges Time: 14:40–15:00 London time (BST) Key FORS moments discussed Time: 15:00–15:30 London time (BST) Reduction of Radiation Challenges (continued) Time: 15:30–15:50 London time (BST)

Best of CX and prize abstracts Time: 12:00–12:30 London time (BST) CX Aortic Arch & Thoracoabdominal Techniques Time: 12:30–13:30 London time (BST) Best of CX and prize abstracts Time: 13:30–14:00 London time (BST) CX Aortic Arch & Thoracoabdominal Techniques (continued) Time: 14:00–15:00 London time (BST) Best of CX and prize abstracts Time: 15:00–15:30 London time (BST) Best of Italian Abstracts and Society of Vascular and Endovascular Surgery (SICVE) Time: 15:30–16:00 London time (BST) Best of Italian Abstracts and Society of Vascular and Endovascular Surgery (SICVE) Time: 16:00–16:30 London time (BST)

CX Aortic Dissection Challenges Time: 16:20–16:30 London time (BST)

CX EVAR Durability Questioned Time: 15:50–16:30 London time (BST)

Best of Austrian Society of Vascular Surgery (OGG) Abstracts Time: 16:30–17:00 London time (BST)

Industry Satellite: Endovascular treatment of Type B aortic dissection Time: 16:30–17:00 London time (BST)

The need for Personalised Solutions in Aortic Repair Time: 16:30–17:00 London time (BST)

Best of German Society for Vascular Surgery and Vascular Medicine (DGG) Time: 17:00–17:30 London time (BST)

CX Aortic Dissection Challenges (continued) Time: 17:00–18:00 London time (BST)

CX EVAR Durability Questioned (continued) Time: 17:00–17:20 London time (BST)

Best of Swiss Society for Vascular Surgery (SGG) Time: 17:30–18:00 London time (BST)

Ruptured Abdominal Aortic Aneurysm (AAA) Time: 17:12–18:00 London time (BST)

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Issue 91 | September 2021

CX Aortic Vienna 17

CX AORTIC VIENNA

CX Aortic Vienna 2021 to address key questions in the field The balance of open and endovascular aortic care with Gustavo Oderich Gustavo Oderich (University of Texas Health Science Center, Houston, Texas) talks about the future of Zone 0 treatment, describing it as “the last frontier” to be taken over by endovascular means. Oderich stresses the importance of multidisciplinary collaboration with cardiac and interventional cardiology specialists, particularly for Zone 0 procedures.

What is the future of endovascular and open techniques in Zone 0?

Zone 0 is the last frontier and I do not underestimate it. I have experienced three of the four possible major complications that can happen in Zone 0: wire perforation of a ventricle; retrograde type A; and injury of the aortic valve. I have not yet seen coverage of the coronary arteries, but I know others who have done, and so we have to be careful with that as well. Zone 0 treatment is evolving fast with the advent of transcatheter aortic valve replacement (TAVR) and arch devices, and I am sure at some point we will all be doing endovascular Bentall procedures, but there is still a way to go.

What are your thoughts on the Endo-Bentall procedure?

The major challenge with this procedure is going to be stenting the coronary arteries and assuring nearly 100% technical success and patency, given the high stakes of a failed procedure. The coronaries are very small vessels prone to spasm; therefore we typically have

to work with 0.014 or 0.018 systems. The stent graft technology is just not there yet. The other challenge is that current percutaneous valves are designed for stenotic disease and not for normal valves or valves with insufficiency, so the fixation of the device is going to be an issue. Again, the technology is not there yet. We have to focus on creating a device that is not going to migrate.

Is multidisciplinary collaboration necessary for complex endovascular procedures?

I think for Zone 0 you should have a multidisciplinary team that involves cardiac surgeons, along with vascular surgeons, cardiovascular anaesthesia and also interventional cardiologists, because we know things are going to move towards the aortic valve, towards the coronaries, and no single specialty has the expertise to deal with all the potential complications.

Is there a place for an aorticonly meeting to consider total aortic management?

Absolutely, and I think that CX Aortic Vienna is a great example of such a meeting. It has an excellent group of people putting together the programme, addressing the most pertinent questions to be answered in the aortic field. Also, we know multidisciplinary involvement is important, and CX Aortic Vienna is an opportunity in a more concise meeting to bring together all specialties to talk about aortic disease.

The future of aortic care with Tilo Kölbel

A conversation with Joseph Coselli

Tilo Kölbel (German Aortic Center and the University Heart Center, Hamburg, Germany) speaks about the excitement surrounding his edited case demonstrating a “Branched endovascular repair of Type IV thoracoabdominal aortic aneurysm using FORS [Fiber Optic RealShape; Philips] laser light guidance”. Kölbel predicts this “disruptive new” technology will change imaging during the management of aortic disease in the future.

Joseph Coselli (Baylor College of Medicine, Houston, USA) talks about the pioneers of the aortic field and future of aortic practice. Coselli advocates the “need not to have silos” and that instead “we need to have teams” involving interventional radiology, cardiac, vascular and endovascular specialists to promote a shared growth throughout the field.

What are you most looking forward to at CX Aortic Vienna 2021?

I am most excited about the discussion of open or endovascular aortic arch repair. There will be debate between open cardiac surgeons and endovascular surgeons in order to determine which patients and which anatomies should be treated with endovascular therapies. I very much look forward to discussing this with open surgeons as I am a strong proponent for the endovascular techniques.

Is it justified to have a meeting entirely dedicated to aortic care? To focus a whole meeting on aortic care is a very good idea because it allows aortic specialists to come together and to focus on this area. I see in other larger, more general meetings that it is more difficult to get together as aortic experts. We are usually distracted by other topics as only a few of us do aortic procedures exclusively.

Why should viewers tune in to your edited case “Branched endovascular repair of Type IV thoracoabdominal aortic aneurysm using FORS laser light guidance”?

I think everybody who wants to see the aortic repair of the future should view this case. FORS offers a radiation-free technology, giving more and better information on the 3D position of our instruments within the patient’s body, so it is endovascular repair in colour and in 3D—that is what I believe endovascular aortic repair will look like in most centres in five to 10 years.

I speak to you from the perspective of having been trained by Michael DeBakey, having had a lifelong personal friendship with Den Cooley, and having spent seven years working with Stanley Crawford, which gave me an opportunity to become very familiar with the thoracoabdominal aorta and vascular surgery across the full spectrum. When we look back at these pioneers in our speciality, we can see that they did procedures and

One of the things that has become very clear to me over the years is that we need not to have silos but we need to have teams.” techniques that they did not do in their training. As they gained knowledge, they reinforced how important it was to share that knowledge, to share their experience, and to teach others. One of the things that has become very clear to me over the years is that we need not to have silos but we need to have teams, which need to include interventional radiologists, radiologists, cardiologists, endovascular specialists, open aortic and vascular teams, etc. It is important we bring together the knowledge of these teams in order to treat the individual patient.

September 2021 | Issue 91

18 Conference Coverage

AORTIC

Thirty-year experience indicates SMA aneurysms are “relatively stable” Based on 30 years of experience, researchers have concluded that aneurysms of the superior mesenteric artery (SMA) are “relatively stable” and that those <20mm may be safely monitored with surveillance imaging. The experience also suggests that operative treatment should be considered if the aneurysms are symptomatic and that patients with vasculitis or fibromuscular dysplasia may need closer follow-up. PRESENTING THESE FINDINGS at the Society for Vascular Surgery’s Vascular Annual Meeting (SVS VAM 2021; 18–21 August, San Diego, USA and online), Grayson S Pitcher (Mayo Clinic, Rochester, USA) notes that the study represents one of the largest series on aneurysms of the SMA and its branches. “SMA aneurysms are rare and the SVS currently recommends repair of all SMA aneurysms and pseudoaneurysms regardless of size,” Pitcher stated. However, he stressed that the rupture rates of true aneurysms versus pseudoaneurysms vary significantly, with a much lower risk for true aneurysms. The presenter detailed that two recent, small series suggest SMA aneurysms <20mm may be safe to observe. In light of this, Pitcher and colleagues at the Mayo Clinic aimed to review

the centre’s 30-year experience with aneurysms of the SMA and its branches, determine their growth rate, and evaluate predictors of growth.

Study details

The research team conducted a retrospective review of all patients diagnosed with an aneurysm of the

Medical therapy linked with low early mortality in type B aortic intramural haematoma patients Medical management of type B aortic intramural haematomas is associated with low early mortality but a 19% risk of aortic-related intervention—primarily for proximal descending thoracic aneurysms, researchers from the Mayo Clinic in Rochester, USA, have found.

he investigators report that elevated creatinine, the haematoma thickness and aortic diameter at presentation portend eventual failure of medical management. The findings were delivered during Plenary Session 4 at the Society for Vascular Surgery’s Vascular Annual Meeting (SVS VAM 2021; 18–21 August, San Diego, USA and online) by Parvathi W Balachandran (Mayo Clinic, Rochester, USA). The study aimed to evaluate the natural history of medically treated aortic intramural haematomas and identify factors linked to faltering medical management. Balachandran and colleagues gathered data from consecutive patients diagnosed with type

SMA or one of its branches— associated with saccular excluding pseudoaneurysms (OR, 0.91; 95% CI, 0.76–1.1; and mycotic aneurysms—in p=1.1) or dissection-associated the period 1988–2018. aneurysms (OR, 1.2; 95% CI, Demographics, presentation, 0.91–1.5; p=0.2). aetiology, anatomic characteristics, and treatment Variables associated modalities were taken into with growth Grayson S Pitcher The team then used logistic consideration. Endpoints included outcomes, growth, regression models to assess and predictors of growth. the effect of multiple variables on Pitcher communicated that a total of growth. Pitcher said that while the 131 patients, or 144 aneurysms, were team evaluated a range of variables, included in the study. The average age the overwhelming majority were not of the patients was 60, 84 (64%) were associated with growth. male, and 66% of the aneurysms were The presenter revealed that degenerative, representing the most symptomatic status was significant and common aetiology. The majority of the that acute abdominal pain (OR, 5.91; aneurysms were found incidentally, with 95% CI, 1.56–22.41; p=0.0009) and only 27% being symptomatic. chronic abdominal pain (OR, 3.76; Growth rate of the aneurysms was 95% CI, 1.06–13.13; p=0.04) were first estimated using linear regression. significantly associated with growth rate. However, only 16% had a growth rate of Finally, Pitcher informed the audience ≥1mm per year. Due to the large number that there were only two ruptures in of aneurysms without any change in the team’s series. One of these ruptures size, aneurysms were dichotomised occurred in a 24mm saccular branch by slope and a categorised aneurysm and the other in a 12mm analysis was performed using fusiform branch aneurysm. He added logistic regression. that only one of the ruptures occurred in Addressing the SVS VAM an aneurysm less than 20mm in size out audience, Pitcher reported: of a possible 106 aneurysms. “Initial aneurysm size was significantly associated with growth rate for fusiform aneurysms only, meaning initial size is only predictive of growth for fusiform aneurysms”. The odds ratio (OR) for the fusiform aneurysm growth rate was 1.13 (95% confidence interval [CI], 1–1.3), with a p-value of 0.02. Initial aneurysm size was not significantly

The study represents one of the largest series on aneurysms of the SMA and its branches.”

B haematomas from 1995 to 2019. A total of 91 were identified. All patients received antihypertensive medications and pain control. Initial management was best medical therapy in 85% (n=77) and surgery in 13% (n=12) of patients. Two patients declined intervention and died within 48 hours, “hence were not included in the study,” said Balachandran. The primary outcome of the study was 30-day mortality. Secondary outcomes included five-year all-cause and aortic-related mortality, as well as aortic related surgical intervention for dissection or aneurysm. Balachandran et al found that 30-day mortality was 5% (n=4) among the best medical therapy group and 17% (n=2) in the surgery treatment group. All-cause five-year mortality was comparable between groups (57% vs 50%, p=0.8), with a median survival of 6.8 years after therapy and 5.9 years after surgery. “However, five-year aortic-related mortality was higher in the surgical group at 25% compared to best medical therapy due to high perioperative mortality,” Balachandran said. Of the 77 patients who were managed with best medical therapy, Balachandran told SVS VAM attendees, 19% (n=15) worsened and eventually required surgery for dissection (n=3) and aneurysm (n=12)—13% had surgery within two weeks of initial diagnosis and 87% required a late surgical intervention. Of the 81% who continued on the best medical therapy track, 2% succumbed to early in-hospital death. The median freedom from intervention was 4.6 years. On univariate analysis, coronary artery

disease, hypertension, baseline creatinine level, peripheral arterial disease, active smoking, intramural haematoma thickness and maximum aortic diameter were independent risk factors for subsequent need for surgery after medical management, the research team discovered. On multivariate analysis, chronic kidney disease with a creatinine >1.2mg/dL, intramural haematoma thickness (>7.7mm) and aortic diameter (>42mm) were predictive risk factors. Meanwhile, reintervention after initial surgical management was required in 25% (n=3), for aneurysm, endoleak and infected endograft with a median freedom from reintervention of 5.2 (IQR 3–7.9) years.

Given the nearly fiveyear time between type B aortic intramural haematoma and need for surgery beyond 30 days, diligent follow-up is needed.” Balachandran concluded: “Given the nearly five-year time between type B aortic intramural haematoma and need for surgery beyond 30 days, diligent follow-up is needed. These findings provide useful information to guide patient expectations and optimal treatment.”

Issue 91 | September 2021

Journal Highlights 19

Performance of commonlyused risk scores for AAA repair varies, study finds As regards in-hospital mortality for abdominal aortic aneurysm (AAA) repair, researchers have found that “not all risk scores are created equal”. Livia E V M de Guerre (Beth Israel Deaconess Medical Center, Boston, USA; University Medical Center, Utrecht, The Netherlands) and colleagues have identified performance variation between three commonly-used risk scores in administrative and quality improvement registries, and recently reported their findings online in the Journal of Vascular Surgery (JVS). “ACCURATE AND CONTEMPORARY prognostic risk prediction is essential to inform clinical decision-making surrounding AAA care,” the authors write. For this reason, de Guerre et al decided to validate and compare three different in-hospital mortality risk scores—Medicare, vascular study group of New England (VSGNE), and Glasgow Aneurysm Score (GAS)—in one administrative and two quality improvement registries. Writing in JVS, the authors report that the VSGNE risk score performed best in the quality improvement registries but underestimated mortality. However, they add, the Medicare risk score demonstrated better calibration in the administrative dataset after open repair. Although the VSGNE risk score appeared to perform better in the quality improvement registries, the authors note that “its overly-optimistic mortality estimates and its reliance on detailed anatomic and clinical variables reduced broader applicability to other databases”. The researchers included patients undergoing elective AAA repair from 2012–2015 in the national inpatient sample (NIS), the vascular quality initiative

(VQI; excluding the VSGNE region), and the national surgical quality improvement programme (NSQIP) datasets to validate the three risk scores. De Guerre and colleagues identified a total of 25,461 NIH, 18,588 VQI, and 8,051 NSQIP patients who underwent elective open or endovascular aneurysm repair (EVAR). Regarding mortality, they report the following key finding: “Overall, the Medicare risk score was more likely to overestimate mortality in the quality improvement registries, while the VSGNE risk score underestimated mortality in all databases”. The authors add that, after EVAR, the Medicare risk score had a higher area under the curve (AUC) in the NIS compared to GAS (p<0.001) but not compared to the VSGNE risk score (p=0.54). In addition, they found that the VSGNE risk score was associated with a significantly higher receiver operating characteristic (ROC) AUC compared to the Medicare (p<0.001) and GAS risk score (p<0.001) in the VQI registry, and that the VSGNE risk score showed improved calibration compared with the Medicare risk score across all three databases

Translumbar embolisation for type II endoleak “safe and effective” following EVAR, study suggests Writing in an article published online in the Journal of Vascular Surgery (JVS), John F Charitable, Neal Cayne (both NYU Langone Health, New York, USA), and colleagues conclude that translumbar embolisation is a safe and effective treatment option for type II endoleak with aneurysm growth following endovascular aneurysm repair (EVAR). THE AUTHORS ADD THAT patients taking antiplatelet medication and those with larger aneurysms at the time of endoleak identification appear to be at increased risk for persistent endoleak and need for subsequent procedures following initial translumbar embolisation. “These patients may require more intensive monitoring and follow-up,” they write. In order to investigate the outcomes of translumbar embolisation for type II endoleaks following EVAR, the investigators conducted a retrospective chart review of patients with type II endoleak after EVAR, treated from 2011–2018 at a single academic institution. They detail that treatment indications were the presence of persistent type II endoleak and aneurysm growth ≥5mm, with sac

stabilisation being defined as growth ≤5mm throughout the follow-up period. Charitable, Cayne and colleagues detail that 30 patients were identified, the majority of whom were men (n=24) with a mean age of 74.3 years (95% confidence interval [CI], 70.9–77.6). The researchers detail some key parameters of the study cohort: the mean maximal sac diameter at type II endoleak discovery was 5.8cm (95% CI, 5.4–6.2); the mean time to intervention from endoleak discovery was 33.7±28 months with a mean growth of 0.84cm (95% CI, 0.48–1.2) during Neal Cayne that time

(all p<0.001). After open repair, de Guerre et al continue, the Medicare risk score showed improved calibration compared with the VSGNE risk score in the NIS (p<0.001). However, in the VQI registry, they note that the VSGNE risk score compared to the Medicare risk score had significantly better discrimination (p=0.008) and calibration (p<0.001). The authors consider some of the reasons behind the variation. They recognise, for example, differences in variable definitions and availability between the databases that were used to create the risk models and the datasets to which the researchers subsequently applied each risk score. De Guerre and colleagues also highlight that the different patient populations represented within the datasets have different distributions of risk factors.

Accurate and contemporary prognostic risk prediction is essential to inform clinical decision-making surrounding AAA care.” In the discussion of their findings, the researchers stress that their results “need to be interpreted within the context of [the study’s] limitations”. For example, they recognise that that broader generalisability of their findings and recommendations towards universal applicability in clinical and research settings is “not straightforward” due to the inclusion of only three risk scores. However, they stress that scores they examined are the most commonly used among

period; and the mean follow-up time after translumbar embolisation was 19.1 months (95% CI, 11.1–27.2). A total of 28 patients were treated with cyanoacrylate glue alone, and two were treated with cyanoacrylate glue plus coil embolisation, Charitable, Cayne et al relay. The authors report in JVS that there was immediate complete endoleak resolution as assessed intraoperatively, and sac stabilisation in 15 cases (15%). Eleven patients (36.7%) had evidence of persistent type II endoleak on initial imaging after the embolisation procedure, the investigators reveal, noting that additional follow-up indicated eventual sac stabilisation at a mean of 21.3±7.2 months and therefore no need for further intervention. In the remaining four cases (13.3%), Charitable, Cayne and colleagues communciate, there was persistent type II endoleak after the inital translumbar embolisation requiring a second intervention. They write that repeat translumbar embolisation stabilised growth in three of these four patients after a mean of 17.6±12.9 months, and that one patient required sacotomy and ligation of lumbar vessels due to continued

persistence of the type II endoleak and continued aneurysm growth. “There were no ischaemic complications related to the embolisation procedures,” Charitable, Cayne et al note, detailing factors associated with persistent endoleak after initial embolisation were larger aneurysm diameter at the time of initial endoleak identification (p<0.001), and the use of antiplatelet agents (p<0.02). They add that the use of anticoagulation was not a significant risk factor for endoleak recurrence of aneurysm growth after translumbar embolisation.

Patients taking antiplatelet medication and those with larger aneurysms at the time of endoleak identification appear to be at increased risk for persistent endoleak.”

September 2021 | Issue 91

20 Interview

PROFILE

Joseph E Bavaria

“I would say that the future is incredibly bright for cardiovascular surgeons,” Joseph E Bavaria tells Vascular News. The 52nd president of the Society of Thoracic Surgeons (STS), Bavaria first studied engineering before pursuing a career in cardiovascular surgery, starting as an attending surgeon in 1993 in time to partake in the endovascular “revolution” of the mid to late 1990s. Considering the future of cardiovascular surgery, Bavaria believes that advanced technologies and techniques will open up new possibilities in treatments, but stresses that such developments must be democratised. He sees training and education as one of the biggest challenges facing cardiovascular surgery, with societies across the world not recognising the huge commitment needed to the speciality, and sees the need for a wider recognition of the pre-eminence and importance of cardiovascular disease treatment.

The reason why I decided to go into medicine is a little circuitous. I had come from a family of engineers, and my father’s approach to life was, ‘no matter what you want to do, go to engineering school first and then do that’. At first I really wanted to be a lawyer, but two things changed this. The first was that my grandfather— who, along with my grandmother, lived in our house with us in Cincinnati, Ohio—was dying of amyotrophic lateral sclerosis (ALS), and that affected me a lot. The second thing was that our next door neighbour in Cincinnati was a general and vascular surgeon. I got to know him and ended up being influenced by him. There were a couple of things that turned me towards cardiovascular surgery. Number one, I found that I was pretty good at the physiology and the medical part of the cardiovascular system, and it was very aligned with my engineering background in that era, which was the 1980s. The second thing was that, every summer, I used to work at the hospital where the next door neighbour I refer to above was a surgeon. The very last rotation I did there was in cardiovascular surgery and I was just fascinated. At that point I decided to go into cardiovascular surgery.

Who have been your career mentors?

I have had a number of career mentors. In chronological order, L Henry Edmunds, past chief of cardiovascular surgery at Penn Medicine and also editor of the Annals of Thoracic Surgery for 15 years, was my first mentor. As a resident, I did research on cardiac biophysics in his laboratory. My second mentor was probably the most important mentor I have had, and this was Timothy Gardner. He was chair of cardiovascular surgery after Edmunds, and he was the president of the American Association for Thoracic Surgery (AATS), which is a big deal—one of two really big global positions in cardiac surgery, the other being the presidency of the STS. Gardner was my mentor through my early career as a cardiac surgeon after my training and was very important. There were a couple of others. On the vascular side was Ronald Fairman, who was not only a mentor but also a colleague. Fairman was the chief of vascular surgery at Penn and was the president of the Society for Vascular Surgery (SVS). One non-local mentor would be Michael Mack, who is one of the most innovative cardiovascular surgeons around and was one of the inventors of the transcatheter valve revolution.

What do you think has been the most important development in cardiovascular surgery during your career to date? The endovascular revolution, so the concept of taking open cardiovascular reconstructive surgery and

therapeutics into the endovascular and endocardiac domain, is probably the biggest thing there is in cardiovascular diseases as a whole, from a therapeutic standpoint. At the very beginning of my career, we did not have these things, but it came pretty quickly after I started in 1993 as an attending physician, and by the mid to late 1990s the endovascular revolution was beginning and on its way. Frankly, I am doing this interview because I was on the ground floor of that revolution and in two different domains: the first one was endovascular treatment of thoracic aortic disease, and the second one was endocardiac treatment of valvular heart disease.

How do you anticipate the field might change in the next decade?

I think that the continual march towards increasingly precise endovascular treatment and endocardiovascular treatment will continue. There is going to be a push towards treating areas that have not been able to be treated before, such as the proximal aorta, some of the more complex heart valves, and some of the more complex and anatomical arrangements within the human body including the aortic arch and the thoracoabdominal aorta. I think that is going to be a revolution in the next 10 years.

I think there is finally going to be recognition that type A aortic dissection is a total aortic catastrophe, not just a localised catastrophe.”

Andy Watt/NB Illustration

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

In addition, and this is a bit more specific, I think there is finally going to be recognition that type A aortic dissection is a total aortic catastrophe, not just a localised catastrophe, and that the treatment paradigm is going to have to include both an open and an endovascular solution in its entirety. I think that we are finally going to be able to do that with advanced surgical techniques and advanced endovascular techniques. The other thing is that we are going to be very focused on decreasing stroke and decreasing cerebral complications from these procedures.

What do you think are the biggest challenges currently facing cardiovascular surgery?

One of the major challenges is the cost of technology. There are many new technologies and techniques to treat cardiovascular disease, but these are not available to most of the world, because they are very expensive. We

are going to have to come up with solutions so that these incredible technologies can be applied across the whole world. The second challenge relates to training and education. Cardiovascular surgery is hard. It is hard on your brain, your body and your time, and requires a certain dedication. Unfortunately, it seems like societies across the world are not valuing this commitment and as a result, the trainees coming through medical school today and through residency, they do not want to do it. Why would they want to do something like this if it is valued and paid at the same rate as anything else? We have a huge problem, and this is true in the UK and Europe as well as the USA, that is a shortage of specialists who can actually do this stuff. I suppose the last challenge is organisational. Cardiovascular diseases are essentially neck and neck with cancer as becoming the most common diseases in humans above a certain age, and I am sceptical as to

Issue 91 | September 2021

Interview 21 whether that is properly understood by administrators and politicians. We must recognise the pre-eminence and importance of cardiovascular disease treatment.

What are your current areas of research?

One of my main areas of research has to do with understanding the genetic basis of aneurysmal disease, so genetically-triggered aortic conditions, especially in the proximal aorta. This represents a huge knowledge gap that must be addressed. It is also really important because, unfortunately, it is not acquired disease, it is just fate, and it usually affects younger people. The second area of research is the application of endovascular treatment into the proximal aorta. This is the biggest therapeutic area that we are working on. The third thing is the recognition and then subsequent treatment of type A aortic dissection as a total aortic catastrophe. We are moving towards an understanding that at the index procedure and at the index part of the disease process you can make a big difference.

You are on the Executive Board for CX Aortic Vienna 2021. What should viewers look out for?

We should look out for the continually improving results of endovascular aortic surgery proximally and pay special attention to stroke rates and improved arch graft design. Number two would be data pointing to the fact that acute type A aortic dissection is a total aortic catastrophe, and not just an ascending issue. And then there are the subsequent new therapeutic attempts at treating this condition with greater emphasis at the index procedure towards stabilising the entire aorta. Number three would be longer-term endograft data in the thoracic aorta, looking at solid five- and ten-year data from really reputable studies.

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

I would say that the future is incredibly bright for cardiovascular surgeons. It is a broad field and there will be something for anyone who is interested in this area from peripheral vascular surgery more towards the pure cardiac side. There is probably going to be a limited but real need for cross-trained individuals who are both cardiac and vascular boarded—these are going to be your “true” aortic surgeons who can deal with the entire aorta. That is something that we will need to deal with as a whole, global community in the future.

What are your hobbies and interests outside of medicine?

Outside of work, I enjoy golf, travelling the world (I grew up in Europe), wine, which is intertwined with my love of travel. Also, while I am not a hunter, I enjoy trap and skeet shooting.

Fact file Current faculty appointments

2014–present: Surgical director of the Heart and Vascular Center, Hospital of the University of Pennsylvania, Philadelphia, USA 2004–present: The Brooke Roberts– William Maul Measey professor of surgery, University of Pennsylvania School of Medicine, Philadelphia, USA

Current hospital and administrative appointments (selected)

2018–present: Founder/director, Penn Aorta Center 2003–present: Vice chief, Division of Cardiothoracic Surgery, University of Pennsylvania Health System, Philadelphia, USA 2002–present: Director, Clinical Research Program, Cardiothoracic Surgery, University of Pennsylvania Health System, Philadelphia, USA

Honours and awards (selected)

2019–2023: President, The Thoracic Surgery Foundation 2016–2017: President of the Society of Thoracic Surgeons (STS) 2009: Received the “Innovator of the Year” award from Penn Health System

September 2021 | Issue 91

22 Journal Highlights

PERIPHERAL

Latest meta-analysis on paclitaxel in peripheral arterial disease provokes mixed reception

equally for intermittent claudication (52%) and chronic limb threatening ischaemia (CLTI; 48%). The median follow-up period was two years. Authors report 87 major amputations in 2,216 limbs in the paclitaxel arm (4% crude risk) compared with 41 major amputations in the 1,544 limbs in the control arm (2.7% crude risk). The risk of major amputation was significantly higher for paclitaxel-coated balloons with a hazard ratio (HR) of 1.66 (95% confidence interval [CI] 1.14–2.42; p=0.008, one stage stratified Cox model). The observed amputation risk played out equally across “There appears to be heightened risk of major amputation after use of paclitaxel-coated femoropopliteal (p=0.055) and infrapopliteal (p=0.055) balloons [PCBs] in the peripheral arteries,” findings from a systematic review and metaarteries. The number needed to harm was 35 for CLTI. analysis of randomised controlled trials (RCTs) published in the European Journal of In this systematic review and meta-analysis, authors Vascular and Endovascular Surgery (EJVES) suggest. However, the authors clarify that suggest the summary effect demonstrated a 66% higher the level of evidence is graded moderate, not high, due to scarce events in some studies. relative risk of major amputation in the limbs treated with PCBs, and call for further investigations. nd, leading physicians propose that the “It is essential that we have publications such as this Further, Katsanos and colleagues write that there methodology used needs to be carefully interrogating data on new technologies in an was good evidence of a significant non-linear considered and scrutinised before these unbiased way. There is a natural tendency dose relationship with accelerated risk conclusions are accepted. to believe new technologies will per cumulative paclitaxel dose (chi Clarifying at the outset that he is not an expert provide better results than square model p=0.007). The 87 major on statistical methodology, globally recognised old ones. It is only by results were also stable amputations in leader in the development of new less-invasive pooling results from across sensitivity analyses 2,216 limbs in the procedures, Barry T Katzen, founder and medical published trials that (clarified as pertaining paclitaxel arm director of Miami Cardiac & Vascular Institute, enough numbers are to different models and (4% crude risk) Miami, USA, and the president of the CLI Global amassed to detect subgroups, based on Society, tells Vascular News: “As a physician engaged trends which might be anatomy and clinical in multidisciplinary limb salvage with a view to missed by individual indication and excluding improving quality of life by preventing amputations trials. Katsanos and unpublished trials). 41 major amputations and death due to critical limb ischaemia, the colleagues are to Ziv Haskal in 1,544 limbs in the conclusions from this meta-analysis are of concern, be commended for (University of Virginia, of course, and need to be taken seriously. However, highlighting the Charlottesville, USA), control arm (2.7% in parallel I have questions about the complex increased risk of the former editor (2011– crude risk) methodologies used in this paper to arrive at a finding amputation with PCBs 2020) of the Journal of that prospective RCTs have not demonstrated. From a and, as they say, this Vascular and Interventional practical point of view, before accepting the conclusion now needs to be confirmed or Radiology (JVIR) tells Vascular regarding the risk of paclitaxel drug-coated balloon refuted by further investigations.” News: “Dr Katsanos and the use, there needs to be a significant discussion and Commenting on the research team stand, again, to analysis of the methodologies employed in this paper. publication in EJVES, Younes shake-up the PCB planet with This needs to be undertaken by appropriate statistical Jahangiri, statistical editor of a suggested finding of worse experts before these findings change practice, if they the Journal of Vascular and amputation—the same goal do so at all.” Interventional Radiology, paclitaxel was intended This latest meta-analysis, authored by says: “The manuscript to make better, and with Konstantinos Katsanos (Patras University Hospital, has used a robust search a dose-dependent effect. Rion, Greece) and co-authors from France, Germany, strategy and meta-analysis Unsurprisingly, it is a Finland and The Netherlands, drills down on the longtechniques. Nevertheless, rigorous and clear-headed term risk of major amputation alone associated with there are a considerable analysis. But there are use of PCBs in the lower limbs. The findings point number of backinterpolations, intercalations to a significantly higher long-term risk of major limb calculations and imputations and imputations, likely to loss using these devices in the femoropopliteal and/or that have been performed for bring out critics, with force. infrapopliteal arteries. data generation, which might This may be a curtain raiser, but Anna Maria Belli, a former consultant radiologist not necessarily fit with realthe main play is yet to unfold.” and Professor of Interventional Radiology at St. world data. Additionally, exclusion George’s Hospital and of studies with no events in both arms, Medical School in especially if the studies were of high quality and London, UK, a past adequate follow-up, might have led to overestimation president of the of the crude risk in both groups and potentially to the Cardiovascular statistical significance of between-group differences. and Although the meta-analysis itself suggests an alarming Interventional signal in a heavily computational way, confirmation of Radiological accuracy and adequacy of the signal would still require Society of real-world targeted data.” Europe (CIRSE) The harm signals suggested for paclitaxel and proponent devices from previous meta-analyses have not been of evidence-based substantiated by a wealth of real-world datasets that trials, comments: have shown no long-term safety concerns, and instead suggested increased benefits with the use of paclitaxelcoated devices. Importantly, an interim mortality analysis of the SWEDEPAD registry randomised trial did not confirm a heightened mortality risk in cases of paclitaxel treatment, as noted in the EJVES paper. – As reported in EJVES, the investigators performed a literature search last updated on 20 February 2021 to Barry T Katzen Barry T analyse 21 RCTs with 3,760 lower limbs treated nearly Katzen

87 2,216

41 1,544

From a practical point of view, before accepting the conclusion regarding the risk of paclitaxel drugcoated balloon use, there needs to be a significant discussion and analysis of the methodologies employed in this paper.”

Issue 91 | September 2021

Journal Highlights 23

Nationwide study identifies sex disparities in long-term mortality after paclitaxel exposure A German claims-based cohort study has revealed that—in 13,204 patients treated with a paclitaxel-coated device for peripheral arterial disease (PAD)—mortality differences were mostly attributable to a female subgroup treated above the knee, while no statistically-significant differences were observed in male patients. These findings were recently published in the Journal of Clinical Medicine (JCM).

Christian-Alexander Behrendt

AUTHORS CHRISTIANAlexander Behrendt (University Medical Center Hamburg-Eppendorf, Hamburg, Germany) and colleagues note that, while randomised controlled trials (RCTs) have reported excess mortality in patients treated with paclitaxel-coated devices versus uncoated devices, observational studies have reported the opposite. The researches aimed, therefore, to elucidate the underlying factors driving an observed improvement in mortality associated with paclitaxel exposure in patients with PAD.

of patients with an index of endovascular revascularisation for symptomatic peripheral arterial occlusive disease between 2013 and 2017 was included. In total, 13,204 patients (54% females, mean age 74±11 years) were followed for a median of 3.5 years. The authors report that female patients were older (77 vs. 71 years), and had less frequent coronary artery disease (23% vs. 33%), dyslipidaemia (44% vs. 50%), and diabetes (29% vs. 41%), as well as being less likely to have a history of smoking (10% vs. 15%) compared with male patients.

Behrendt et al studied multicentre health insurance claims data from a large German insurance fund, BARMER. They detail that a homogenous sample

Ongoing and future trials should take sex disparities into account.”

Researchers recommend “timely interventions by specialists and guideline-based treatment” to reduce amputation rates A population-based study from 2013 to 2015 in Germany has found that nearly one fifth of patients with peripheral arterial disease (PAD) did not receive guideline-based vascular diagnostics three months before incidence amputation. Writing online in the European Journal of Vascular and Endovascular Surgery (EJVES), authors Kristina Hagenström (University Medical Center Hamburg-Eppendorf, Hamburg, Germany) and colleagues say this “reflects an underuse of health services”. In addition, the researchers report that, in one third of patients who did not receive vascular surgery, major amputation “probably could have been avoided”.

ue to a wider international variance in major amputation, high mortality rates and follow-up, and the “significantly reduced quality of life for patients with amputations,” the authors stress that vascular diagnostics and vascular surgery treatments “are of great importance” for lower limb preservation in patients with PAD. They note that patients with PAD have an increased risk of lower limb amputation, and that the prevalence of PAD and chronic limb-threatening ischaemia (CLTI) is expected to increase due to demographic trends. The guidelines state that vascular diagnostic and vascular surgical treatments can contribute significantly to the preservation of the lower extremities, and also that early revascularisation can minimise the risk of amputation. In a retrospective longitudinal study, Hagenström et al examined these guidelinebased procedures in patients before a first lower limb amputation and PAD. The researchers analysed data from a large German statutory health insurance (SHI) scheme on patients with first amputation of lower extremities and PAD between 2013 and 2015. They considered pre-defined vascular diagnostic and vascular surgical procedures, as specified by guidelines with inpatients and outpatient care in a defined time before lower limb amputation, Hagenström and colleagues detail.

Reporting their findings in EJVES, the authors relay that the overall estimated incidence of lower extremity amputations in the total population was 0.12% from 2013–2015. Of these patients, they specify, 51.7% had PAD, 81.8% had received at least one diagnostic measure, and 61% a vascular surgery procedure before the lower extremity amputation. Hagenström et al add that there were only minor variations in the use of diagnostic or surgical treatments between patients with major and minor amputations. “In total, 63.9% of patients had vascular surgery before the incidence major amputation compared with 60% of patients with a minor amputation,” they reveal. The investigators highlight “noticeable” regional

Timely interventions by specialists and guideline-based treatments could reduce the number of amputations and subsequent costs.”

In regard to mortality differences, Behrendt and colleagues relay that these were mostly attributable to the female subgroup who were revascularised above the knee (hazard ratio [HR], 0.78; 95% confidence interval [CI], 0.64–0.95), while no statistically significant differences were observed in male patients. “This study found that female patients treated above the knee benefitted from paclitaxel-coated devices, while no differences were observed in male patients,” the authors conclude in JCM. In addition to this fact, which Behrendt et al state has not previously been reported, they found evidence once again for a female patient disadvantage in real-world data. They write: “It appears likely that previously underprivileged female patients benefit from treatment with paclitaxelcoated devices, an association that is moderated through improved optimal pharmacological treatment during follow-up.” However, they note that this subgroup seems to be excluded from previous trials (in Germany)—a fact that would explain a selection bias, they state. Considering how their findings might impact further research in the area, the authors posit: “Ongoing and future trials should take sex disparities into account”.

differences in the data, ranging from 91% (Berlin) to 67% (Bremen) regarding diagnostic procedures provided before amputation, and from 83% (Hamburg) to 55% (Saxony-Anhalt) regarding vascular surgery before amputations. “Timely interventions by specialists and guideline-based treatments could reduce the number of amputations and subsequent costs,” the authors conclude. Commenting on the strengths of their study, they write that its design “permits analyses of a vast and unselected nationwide cohort” and is thus comparable with publications from other countries where population-based data were used. However, they stress that different healthcare systems must be considered. Hagenström and colleagues also acknowledge some limitations of their study, including the fact that the analysed administrative data are based on only one of several SHI companies in Germany, which limits the transferability of the statements made to the population of Germany as a whole.

Kristina Hagenström

September 2021 | Issue 91

24 Scientific Statement

AHA scientific statement provides update on epidemiology, diagnosis and management of PAD The American Heart Association (AHA) has released a new scientific statement on lower extremity peripheral arterial disease (PAD), focusing on contemporary epidemiology, management gaps and future directions. THE STATEMENT, AUTHORED by Michael H Criqui (University of California San Diego, San Diego, USA) and colleagues, has been published in Circulation.

Lower extremity PAD affects more than 230 million adults worldwide, the authors detail, adding that the condition is associated with an increased risk of various adverse clinical outcomes,

Favourable costeffectiveness results for endovascular SFA treatment in claudicants From a cost-effectiveness standpoint, primary stenting of the superficial femoral artery (SFA) for the treatment of intermittent claudication can, in many countries, be used as an adjunct to exercise training advice. This is the main conclusion of Henrik Djerf (Sahlgrenska University Hospital, Gothenburg, Sweden) and colleagues, reporting two-year results of a randomised, multicentre trial online in the European Journal of Vascular and Endovascular Surgery (EJVES). DJERF ET AL CONSIDER WHAT THEIR PAPER add to the literature: “This examination of the cost effectiveness within a randomised controlled trial for endovascular treatment of the SFA in patients with intermittent claudication adds longer follow-up data than previous studies.” The authors write that invasive treatment of intermittent claudication is commonly performed, despite limited evidence of its cost effectiveness. In addition, they note that endovascular treatment is

including cardiovascular diseases such as coronary heart disease and stroke, and leg outcomes such as amputation. Despite its prevalence and clinical importance, however, Criqui et al highlight a multifactorial underappreciation of PAD by healthcare professionals and patients, combining limited availability of the first-line diagnostic test—the ankle-brachial index—in clinics, and incorrect perceptions that a leg vascular disease is not fatal and that the diagnosis of PAD would not necessarily change clinical practice. In addition, the authors relay that many patients with PAD are not receiving evidence-based therapies. The new statement is designed to address these issues by providing an

performed frequently due to the fact that symptoms of intermittent claudication are mainly caused by atherosclerotic lesions in the SFA. The aim of the present study, Djerf and colleagues relay, was to investigate the cost effectiveness of endovascular treatment versus its non-invasive counterpart. The researchers randomised 100 patients with intermittent claudication due to lesions in the SFA to treatment with primary stenting, best medical treatment and exercise advice, or to best medical therapy and exercise advice alone (the control group), noting that patients were recruited from seven hospitals in Sweden. For their present analysis of cost effectiveness after two years, the investigators analysed 84 patients with data on quality-adjusted life years (QALYs). Writing in EJVES, Djerf et al report that the mean cost per patient was €11,060 in the stent group and €4,787 in the control group, resulting in a difference of €6,273 per patient between the groups. In addition, they found that the difference in mean QALYs between the groups was 0.26, in favour of the stent group, which resulted in an incremental costeffectiveness ratio (ICER) of €23,785 per QALY. The authors conclude that the costs associated with primary stenting in the SFA for the treatment of intermittent claudication were higher than for exercise advice

Henrik Djerf

update for healthcare professionals regarding contemporary epidemiology (i.e. prevalence, temporal trends, risk factors and complications) of PAD, the current status of diagnosis (physiological tests and imaging modalities), and describing major gaps in the management of PAD (i.e., medications, exercise therapy and revascularisation), Criqui and colleagues write. In concluding their statement, the authors look to the future: “Orchestrated efforts among different parties (e.g. healthcare providers, researchers, expert organisations and healthcare organisations) will be needed to increase the awareness and understanding of PAD and improve diagnostic approaches, management and prognosis of PAD.”

and best medical therapy alone. They add that, with concurrent improvement in health-related quality of life, primary stenting was a cost-effective treatment option according to the Swedish national guidelines (ICER <€50,000–70,000) and approaching the UK’s National Institute for Health and Care Excellence threshold for willingness to pay (ICER <£20,000–30,000). In many countries, primary stenting of the SFA is cost-effective and therefore can be used as an adjunct to exercise training advice, Djerf and colleagues summarise. However, they stress that successful implementation of structured exercise programmes and longer follow-up may alter these findings in the future.

This examination of the cost effectiveness within a randomised controlled trial for endovascular treatment of the SFA in patients with intermittent claudication adds longer follow-up data than previous studies.”

Issue 91 | September 2021

Conference Coverage 25

Veterans with claudication who undergo revascularisation “significantly more likely to have major amputation than those who do not” Patients within the Veterans Affairs Administration healthcare system who underwent an intervention for intermittent claudication (IC) were consistently at three-to-four times greater risk of undergoing subsequent amputation compared to those who did not, researchers at Stanford University (Stanford, USA) report.

urthermore, intervention was associated with a 40% greater hazard of disease progression to chronic limb-threatening ischaemia (CLTI), they found. The findings were revealed at the Society for Vascular Surgery’s Vascular Annual Meeting (SVS VAM 2021; 18–21 August, San Diego, USA and online) by Elizabeth L George, a vascular surgery integrated chief resident at Stanford University. George and colleagues looked into the association between intervention for IC, and progression to CLTI and amputation in light of data demonstrating “significant centre-level variability” in adherence to guideline-recommended therapy. Both the Society for Vascular Surgery (SVS) and the American Heart Association (AHA) recommend intervention for IC only after a failed trial of medical and exercise therapy, she said. With recent evidence suggesting intervention for claudication hastens progression of disease in as little as one-and-a-half years, “we sought to answer the question of whether intervention actually carries a risk for limb loss that is worse than the natural history of medically-managed claudication,” George told VAM attendees. George and colleagues carried out an observational national cohort study of veterans diagnosed with IC between 2003–2012, identifying patients with incident peripheral arterial disease (PAD) and focusing on a diagnosis of claudication. The primary and secondary outcomes of the study were, respectively, major amputation progression to CLTI. A total 25,737 veterans were diagnosed with IC at 130 Veterans Affairs medical centres during the study period, with a third undergoing vascular intervention during follow-up. A further 755, or 2.9%, had a major amputation—493 of them within five years of diagnosis. “Veterans who underwent revascularisation were overall significantly more likely to have major amputation than patients who did not [5.6% vs. 1.5%; p<0.001], and this was true at the five-year mark as well,” George revealed. “In adjusted Cox proportional hazard modelling, intervention was associated with three times higher hazard of amputation [adjusted hazard ratio (aHR) 3.60, 95% confidence interval (CI) 2.97–4.39; p<0.001].” Prescription of an antiplatelet agent (aHR 0.77, 95% CI 0.60–0.99; p<0.001] but not statin medication was associated with significantly lower hazard of amputation, George continued. On multivariable logistic regression, she said, intervention was “significantly associated” with three times greater odds of amputation at five years (adjusted odds ratio [aOR] 3.84, 95% CI 3.14–4.69; p<0.001). “But prescription of statins and antiplatelets were not associated with amputation,” she added. “A number of comorbidities were significantly associated but in both

models current smoking status was not.” George et al also found on Kaplan-Meier analysis that veterans who underwent intervention experienced significantly worse amputation-free survival at five years (p<0.001). The researchers delved deeper. “When we used a three-level independent variable— time to diagnosis to intervention less than or greater than six months compared to no intervention—our model revealed that intervention when performed more than six months out from diagnosis was associated with a greater hazard of major amputation compared to earlier intervention,” George explained. “This unexpected finding was also confirmed on KaplanMeier analysis and prompted us to perform a posthoc analysis to incorporate the secondary outcome of progression to CLTI to address the possibility that

Using three different statistical methods as points of comparison, veterans who underwent revascularisation for IC were consistently at threeto-four times greater hazard, odds, risk of undergoing subsequent amputation compared to veterans who did not receive revascularisation for IC.”

these later interventions were actually due to rapid progression of disease.” Using a composite endpoint of CLTI and major amputation, the investigators found that intervention was associated with a 40% greater hazard of disease progression in adjusted Cox proportional hazard modelling. “Intervention for IC is associated with significantly less freedom from disease progression during five-year follow-up on Kaplan-Meier analysis,” George said. “Overall, the rates of disease progression in the veteran population included in this study were quite high, with progression of disease from IC to CLTI noted in 60% of veterans who did not undergo a revascularisation and 75% who did undergo a revascularisation. “Our post-hoc hypothesis that earlier interventions are associated with more rapid progression of disease appears to be confirmed. And we again see that the progression to amputation and CLTI is much slower in veterans who do not undergo an intervention for claudication.” George conceded that her research team’s analysis suffers from a number of limitations, including a lack of granular data on symptomatology either at presentation or during follow-up; the homogenous patient population served by the Veterans Affairs system; the absence of data on supervised exercise therapy (SET); and the fact the covariates in their models do not vary by time. George further pointed out that the study does not account for different practice patterns. Citing the SVS Presidential Address given by Kim Hodgson (Southern Illinois University School of Medicine, Springfield, USA) at SVS VAM earlier in the week, George touched on the controversial use of invasive vascular interventions as a first-line therapy for claudication. “As one of the only risk-based studies that looks at the natural history of claudication, we found that within the VA system 33% of claudicants underwent invasive vascular interventions and, overall, 2.9% of veterans received a major amputation. Amputation risk for those who did not undergo an intervention was 1% at five years,” she said. Concluding, George added: “Using three different statistical methods as points of comparison, veterans who underwent revascularisation for IC were consistently at three-to-four times greater hazard, odds, risk of undergoing subsequent amputation compared to veterans who did not receive revascularisation for IC. And intervention was associated with a 40% greater hazard of disease progression to CLTI. Earlier use of medical and exercise therapy along with appropriate preoperative patient counselling regarding increased amputation risk with revascularisation for IC is warranted. Future research is needed to identify mechanisms and risk factors for accelerated disease progression following intervention as well as to figure out how procedural approach factors into the equation.”

Elizabeth L George presenting at SVS VAM 2021

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September 2021 | Issue 91

28 Venous

Iliac vein stenting for chronic venous obstruction “significantly” improves venous disease-specific quality of life

“significant improvement” from baseline for both the VEINES-QoL and the VEINES-Sym. Detailing specific findings, Morris revealed that the VEINES-QoL at baseline was 35.69, which improved to 64.18 at six months postoperatively. The improvement was sustained at 12, 24, and 36 months at 60.52, 60.37, and 55.98, respectively. The VEINES-Sym showed a similar level Venous disease-specific quality of life (QoL), as measured by the VEINES (Venous of improvement, Morris added, increasing to 60 at six insufficiency epidemiological and economic study)-QoL/Sym, improves significantly months, 52.85 at 12 months, 59 at 24 months, and 50.25 after iliac vein stenting for chronic venous obstruction. This is according to the 2021 at 36 months. “The change from baseline was highly European Venous Forum (EVF) prize-winning paper presented by Rachael Morris (St significant at all follow-up time points,” the speaker Thomas’ Hospital and King’s College London, London, UK) at the 21st EVF Annual Meeting remarked. (24–26 June, online). In addition to improvements in the VEINES-QoL/ Sym, Morris informed viewers that the Villalta score “QOL AFTER DEEP VEIN THROMBOSIS IS the change in leg problem over the last year—and the also improved. The baseline for this cohort was 14, severely impaired,” Morris began, noting that studies VEINES-Sym, a subscale of the VEINES-QoL that which the speaker said represents a cohort of patients have demonstrated impairment comparable to that includes questions relating to symptoms of chronic with “quite severe symptoms” who are “absolutely experienced by patients living with other significant venous disease only. For both the VEINES-QoL and the desperate for something to be done”. At six months cardiovascular, respiratory, and musculoskeletal VEINES-Sym, a higher score equates to a better clinical postoperatively this was nine, improving to 7.5 at conditions such as angina, arthritis, and chronic outcome, the speaker noted. 12 months, seven at 24 months, and finally six at 36 obstructive pulmonary disease. The aim of the current study, Morris relayed, was to months. Again, Morris added, these scores represent Post-thrombotic syndrome (PTS) comes with evaluate change in venous disease-specific QoL after a highly significant change from baseline at each time disabling physical symptoms, Morris explained, iliac vein stenting for chronic obstruction. A secondary point. including leg pain, swelling, venous claudication, aim was to identify factors associated with improvement On examination of factors associated with and venous ulceration—all factors which, the speaker in QoL after stenting. improvement in QoL, Morris reported that the team noted, have a significant impact on patients’ ability to This was a retrospective cohort study, the speaker could identify no factor that was significantly related undertake daily activities. “For some patients,” Morris told virtual attendees. The research team included with an improved QoL outcome, and suggested that elaborated, “even climbing the stairs is a struggle”. all VEINES-QoL/Sym larger studies are required The presenter stated that PTS has a significant questionnaires completed to gain some clarity in this psychological impact as well, and—due to the fact that by patients presenting to the area. some patients are left unable to work because of their St Thomas’ Hospital deep Morris concluded that symptoms—a significant social and economic burden. venous outpatient clinic a significant improvement The “gold standard” for assessment of QoL and before and after iliac vein in venous disease-specific severity of disease in PTS is the Villalta score combined stenting between 2016 and QoL, as reported by the with a venous disease-specific QoL questionnaire, 2019. VEINES-QoL/Sym, Morris informed EVF attendees. The VEINES-QoL/ Morris communicated was accompanied by a Sym is one such questionnaire and has been validated that the group identified 187 corresponding clinical “extensively” in several different languages, Morris patients who had completed improvement in PTS noted. In addition, it is currently recommended by the the VEINES-QoL/Sym syndrome severity, as European Society for Vascular Surgery. questionnaire at baseline measured by the Villalta Morris detailed that the VEINES-QoL/Sym or follow-up in the study score, in patients treated consists of two parts: the VEINES-QoL—a 25-item timeframe, adding that they at the St Thomas’ Hospital questionnaire relating to symptoms of chronic venous analysed 388 questionnaires deep venous outpatient Clockwise from top left: Chair Imre Bihari, disease, limitations in activity due to chronic venous in total. clinic between 2016 Rachael Morris, and co-chair Andrew Nicolaides disease, the psychological impact of the condition, and The speaker reported and 2019.

Researchers find little benefit to stenting for degree of stenosis in CIVO patients A new study suggests that the degree of intravascular ultrasound (IVUS)-determined iliofemoral venous stenosis does not appear to affect the initial clinical presentation, CEAP clinical class, supine foot venous pressure, clinical improvement, quality of life (QoL) improvement, stent patency, or reintervention rates after venous stenting. Arjun Jayaraj (The RANE Center for Venous and Lymphatic Diseases, Jackson, USA) and colleagues relay the findings of their recent investigation into the utility of the 50%-stenosis criterion for patients undergoing stenting for chronic iliofemoral venous obstruction (CIVO) online in the Journal of Vascular Surgery: Venous and Lymphatic Disorders. THE INVESTIGATORS DETAIL that the criterion for venous stenting in symptomatic CIVO has been the “arbitrary” use of stenosis of ≥50% extrapolated from arterial literature. Jayaraj et al conducted a retrospective review of contemporaneously entered electronic medical record data from 480 continuous patients (480 limbs) with initial iliofemoral stents placed (2014 to 2017) for symptomatic CIVO impairing their QoL. The IVUS-determined normal

minimal luminal areas for the common femoral vein (125mm), external iliac vein (150mm), and common iliac vein (200mm) were used to group limbs as having <50% (low-grade stenosis [LGS]) or ≥50% (high-grade stenosis [HGS]) stenosis, Jayaraj and colleagues communicate in their paper. They specify that, of the 480 limbs, 283 and 197 were in the LGS and HGS groups, respectively, also noting a preponderance of women, left laterality, and postthrombotic syndrome in both groups.

The authors report that, at baseline, although no difference was found in the visual analogue scale (VAS) pain score between groups, the LGS group had a higher venous clinical severity score (VCSS) than the HGS group (p=0.05). In addition, they convey that the baseline median supine foot venous pressure was 15 and 14mmHg in the LGS and HGS groups, respectively (p=0.17). At 24 months after stenting, Jayaraj et al reveal that the mean VCSS had improved from 6.3 to 4.4 (p<0.0001) and from 5.7 to 3.7 (p<0.0001) in the LGS and HGS groups, respectively, without significant differences between the two groups (p=0.07). In addition, they found a greater prevalence of ulcers in the LGS group (18% vs. 11%; p=0.04), with no difference in healing (p=0.41) or recurrence rates (p=0.36). The QoL scores had improved in both groups (LGS, from 58 to 37 [p<0.0001], the authors continue; HGS, from 61 to 35 [p<0.0001]), without differences between the two groups (p>3), adding also that no significant differences in stent patency or reintervention rates were found. Finally, they note that a baseline composite chronic venous insufficiency score (CCVIS)—incorporating the VAS score, VCSS, and chronic lower limb venous

insufficiency questionnaire-20 items (CIVIQ-20)—of ≥84.5, ≥86.9, or ≥105.3 was needed for a 30-, 40-, or 50-point improvement in most limbs after stenting. “We need to move away from the ‘stenting for the degree of stenosis concept’ to stenting for symptoms impairing the patient’s QoL,” the authors write in their discussion. They stress that the goal for the treatment of patients with CIVO is to improve their QoL and not typically to save their limb and/or life, which they add are important considerations in the treatment of peripheral arterial disease (PAD).

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Issue 91 | September 2021

Journal Highlights 31

TCAR may be associated with favourable outcomes for treatment of restenotic carotid lesions Transcarotid artery revascularisation (TCAR; Silk Road Medical) may be associated with favourable in-hospital outcomes for the treatment of restenotic carotid lesions after carotid endarterectomy (CEA)—following a study that also evaluated in-hospital outcomes of transfemoral carotid artery stenting (TFCAS) and redo-CEA. WRITING IN THE JOURNAL Stroke, Mahmoud B Malas (chief of Vascular and Endovascular Surgery, UCSD [University of California San Diego], San Diego, USA) et al describe a non-randomised, retrospective analysis of patients undergoing treatment for postCEA restenosis. Despite this indication being linked to a greater risk of ipsilateral stroke, an optimal procedural modality for it has yet to be determined, they note. The study’s researchers analysed a large contemporary cohort of patients in the vascular quality initiative (VQI) database—a prospectively maintained database containing patient- and procedure-speciﬁc data from more than 700 centres across the USA and Canada—who underwent TCAR, redoCEA, or TFCAS, after ipsilateral CEA between September 2016 and April 2020. Patients with prior ipsilateral carotid artery stenting (CAS) were excluded from this analysis, however. The primary outcome in this study was the composite endpoint of inhospital stroke or death, with secondary endpoints being in-hospital stroke, death, myocardial infarction (MI), the composite endpoint of stroke or transient ischaemic attack (TIA), and the composite endpoint of stroke, death, or MI. For the purposes of the study, strokes included any ipsilateral or contralateral cortical or vertebrobasilar

stroke, TIAs included any ipsilateral or contralateral TIA, and MI was diagnosed based on elevated troponin levels or electrocardiogram (ECG) changes. The final patient cohort included a total of 4,425 patients—1,676 TCAR (37.9%), 1,786 TFCAS (40.4%), and 963 redo-CEA (21.8%) patients. TCAR, despite a “considerably higher burden of comorbidities”, was associated with lower odds of in-hospital stroke/death (odds ratio [OR], 0.41 [95% confidence interval [CI], 0.24–0.70], p=0.021), stroke (OR, 0.46 [95% CI, 0.23–0.93], p=0.03), MI (OR, 0.32 [95% CI, 0.14–0.73], p=0.007), stroke/TIA (OR, 0.42 [95% CI, 0.24–0.74], p=0.002), and stroke/death/MI (OR, 0.41 [95% CI, 0.24–0.70], p=0.001) when compared with redo-CEA. There was no significant difference in the odds of death between the two groups (OR, 0.99 [95% CI, 0.28–3.5], p=0.995), Malas et al also report. TCAR was associated with lower odds of stroke/TIA (OR, 0.37 [95% CI, 0.18–0.74], p=0.005) when compared with TFCAS too—although there was no significant difference in the odds of stroke, death, MI, stroke/death, or stroke/ death/MI, between TCAR and TFCAS. “To our knowledge, this is the first and largest study of its kind to demonstrate better perioperative outcomes with TCAR when compared with both TFCAS and redo-CEA in the treatment of recurrent

Higher risk of periprocedural hazards for patients undergoing carotid interventions after thrombolysis A systematic review and meta-analysis has demonstrated that patients undergoing carotid interventions after thrombolysis have a higher risk of periprocedural hazards, compared with those patients who did not have prior thrombolysis. Authors Stavros K Kakkos (University Hospital of Patras, Patras, Greece) and colleagues report their findings in an article published online in the European Journal of Vascular and Endovascular Surgery (EJVES). “PATIENTS UNDERGOING CAROTID endarterectomy (CEA) or carotid artery stenting

carotid disease after endarterectomy,” classes (IV–V), and receive general Malas and colleagues write. “The anaesthesia. Malas et al add that, significant differences in primary and notably, TCAR was associated with a secondary endpoints between TCAR 60% reduction in the odds of stroke/TIA and redo-CEA were evident despite when compared with TFCAS and—after adjustment for patient characteristics, and stratifying by symptomatic status—was several potential confounders.” associated with a 70% reduction in In addition, they note that—although the odds of in-hospital stroke, a 90% they are unable to establish causal reduction in the odds of in-hospital determinants for the unfavourable stroke/TIA, and 50% and 60% reductions outcomes associated with redoin the odds of stroke/death and stroke/ CEA—they believe this may be due death/MI in the asymptomatic group, to longer surgery times with increased although no significant difference was manipulation of the carotid bifurcation, observed among symptomatic patients. and prolonged general These favourable outcomes anaesthetic exposure, but it may be due to the technical could also relate to lesion or advantages of TCAR, anatomic characteristics that they claim, referencing its increased case complexity and utilisation of dynamic flow therefore precluded minimally reversal, which reduces invasive intervention. When cerebral microembolisation. compared with TFCAS, they “Whereas in-hospital add, redo-CEA was associated outcomes from a prospective with higher mortality but Mahmoud B Malas registry are not sufficient similar rates of stroke and MI. to demonstrate the overall, Thus, they recommend avoidance of long-term benefit of any specific redo-CEA in high-risk patients, and assert revascularisation technique, they provide that “the findings in our study align with a real-world evaluation of periprocedural the prior literature and raise questions risks and how they differ based on patient regarding the role of redo-CEA in the demographics and comorbidities,” the treatment of recurrent carotid disease authors write, before concluding that— after endarterectomy”. while their findings support the idea that They also report that their study TCAR may be associated with favourable found patients undergoing TCAR, when outcomes in treating restenotic carotid compared with TFCAS, were more likely lesions—additional long-term studies are to be older (aged over 75 years), have warranted “before we can establish the coronary artery disease, be in higher best procedural therapy for the treatment American Society of Anesthesiologists of restenosis after CEA”.

To our knowledge, this is the ﬁrst and largest study of its kind to demonstrate better perioperative outcomes with TCAR when compared with both TFCAS and redo-CEA in the treatment of recurrent carotid disease after endarterectomy.” Malas et al

(CAS) after thrombolytic therapy have a higher risk of these studies, 2,557 of whom underwent either CEA periprocedural stroke and death, compared with patients (n=2,076) or CAS (n=481) following thrombolysis. undergoing CEA or CAS without prior thrombolytic After CEA, the authors report that the pooled therapy,” the authors write. However, they note that the periprocedural stroke/death rate was 5.2% and difference was statistically significant only for CAS. In intracranial haemorrhage was 2.4%. After CAS, the regards to other hazards, Kakkos et al note that there pooled perioperative procedural stroke/death rate was was also a higher risk of periprocedural intracranial 14.9% and ICH was 5.5%. haemorrhage (ICH) and local haematoma in patients In case control studies comparing CAS outcomes undergoing carotid interventions after thrombolysis. in patients receiving thrombolytic therapy versus no One of the findings that Kakkos and colleagues state thrombolytic therapy, the authors communicate that is “of most practical importance” is that periprocedural periprocedural stroke/death was significantly higher risks of stroke and death appeared to be higher if CEA after thrombolytic therapy (5.2% vs. 1.5%; odds ratio was performed in the first few days after thrombolysis. [OR] 8.49; 95% CI, 2.12–33.95), as was ICH (5.4% vs. This inverse relationship between timing to CEA and 0.7%; OR, 7.48; 95% CI, 4.69–11.92). periprocedural stroke/death “mandates careful patient Kakkos and colleagues also detail that metaselection and suggests that it may be safer to defer CEA regression analysis demonstrated an inverse for six to seven days after thrombolytic association between the time interval from intravenous therapy,” they posit in EJVES. thrombolytic therapy to undergoing CEA and the risk of Using the Medline, Scopus, and periprocedural stroke/death (p=0.032). “Perioperative Cochrane databases, Kakkos et stroke/death was 13% when CEA was performed al identified 25 studies involving three days after thrombolytic therapy and 10.6% when patients who underwent either CEA performed four days after thrombolytic therapy, with or CAS after thrombolytic therapy to the risk reducing to within the currently accepted 6% include in their systematic review threshold after six–seven days had elapsed,” they and meta-analysis. There were write in EJVES, communicating the results of Stavros K a total of 147,810 patients in their analysis. Kakkos

September 2021 | Issue 91

32 ESVS

Towards new horizons: ESVS president introduces hybrid 35th Annual Meeting Following an online-only conference in 2020, this year’s iteration of the European Society for Vascular Surgery (ESVS) Annual Meeting will take a hybrid format, with sessions held in Rotterdam, The Netherlands and online from 28–29 September. ESVS president Hence Verhagen (Erasmus MC, Rotterdam, The Netherlands) outlines what attendees can expect from the two-day event. FOR MANY YEARS THE ESVS ANNUAL Meeting has been bringing together vascular specialists from different parts of the globe to offer a common platform to advance and share knowledge in the field of vascular surgery. In 2020, for the first time ever the meeting was held in a completely new format, with all the educational and scientific activities purely online. All meetings and conferences have followed the same path for the last 18 months, resulting in a widely-felt desire and need to meet each other face to face. Therefore, the Society decided to move towards new horizons and introduce a hybrid 35th ESVS Annual Meeting with sessions held both on-site in Rotterdam as well as online. The Programme and Academy committees have put great efforts to tailor an exciting and highstandard programme with special attention given to providing the audience enough time and tools to interact and connect with the leading experts in the field. With interactivity at the heart of our focus, the programme will feature:

Hence Verhagen

Debates Interviews Q&A sessions Expert discussions High-standard scientific presentations On-site hands-on workshops This year’s scientific programme will include the best science from submitted abstracts, sessions with debates on controversies in vascular surgery, updates on clinical trials, discussions of ESVS guidelines and many other hot topics. In addition, European Vascular Surgeons in Training (EVST) will be organising two dedicated sessions with presentation and discussion of interesting case reports. Furthermore, the ESVS Academy will be offering hands-on workshops for those of you present on-site as well as a set of interactive workshops for those following online, on various topics such as open surgery, venous diseases, trauma management, endovascular treatment, etc. To keep you up-to-date with the latest developments in the device and pharmaceutical industry, our industry partners will be in attendance, offering symposia to present the latest developments and address all your questions.

Upcoming ESVS events and activities: What to look out for in 2022

Secretary General of the ESVS, Maarit Venermo (University of Helsinki and Helsinki University Hospital, Helsinki, Finland) outlines some upcoming Society events and activities beyond the Annual Meeting. WHILE THE ANNUAL MEETING is still at the centre of our attention, at ESVS we are already preparing our next events and activities. The fourth edition of the Mastercl@ss will take place next January and will focus on the treatment of deep and superficial venous diseases. Do not miss the opportunity to attend the state-of-the-art educational event with lectures and cases on various venous topics, live or on-demand. And remember that the Mastercl@ss is free for all ESVS members! 2021 saw the start of the Academy Pathways project, where our Academy Committee launched three distinct

Last but not least we will be thrilled to welcome you at our networking dinner to celebrate a long-awaited reunion. In addition, please note that the 35th ESVS Hybrid Annual Meeting in Rotterdam, The Netherlands, has been accredited by the European Accreditation Council for Continuing Medical Education (EACCME) with 14 European CME credits (ECMECs). In the specific context of the COVID-19 pandemic, ESVS follows very closely, and on a regular basis, the evolution of the restrictions in Europe, and especially in The Netherlands*, in order to have the most accurate and up-to-date information. The Executive Committee trusts that a meeting in Rotterdam will be possible and safe in September. Nevertheless, should the situation go against our plans, we are ready to transform our event into a fully online interactive experience! Obviously, we all feel a great desire to finally

pathways of educational content in both online sessions and onsite handson workshops (coming up during our Annual Meeting in Rotterdam). Our team of dedicated experts prepared sessions to cater for all levels of proficiency, across the following fields: Aortic, Venous and PAD [peripheral arterial disease]. Following the success of the sessions this year, I am very pleased to announce that the Academy Pathways will continue in 2022, with two new pathways being added: Carotid and Vascular Access. Stay tuned and do not miss the opportunity to register! In the coming months, we are

For many years the ESVS Annual Meeting has been bringing together vascular specialists from different parts of the globe to offer a common platform to advance and share knowledge in the field of vascular surgery.”

E C

meet each other in person again, so I am strongly inviting you to join us life in Rotterdam and I am very much looking forward to seeing you all onsite or online during the exciting ESVS 35th Hybrid Annual Meeting!

CMY

* ESVS is delighted to announce that the on-site element of the 35th Annual Meeting will go ahead in Rotterdam with official approval from the Dutch Government

continuing to grow our online educational offer with a great webinar programme. Two additional webinars have already been confirmed and are taking place on the 11 October from 18:30–20:00 CEST (Dual pathway inhibition: a new strategy for all PAD patients) and on the 24 November from 18:30–20:00 CET (Hypo preservation and guidelines). Additional webinars will Maarit Venermo follow in the coming months too, focusing on upcoming ESVS guidelines and major clinical trial releases, among others. They will all be free to access, CME accredited and available on-demand on the e-library. The videos from the webinars will add to the existing repertoire on the ESVS e-library, which gathers all the key educational resources of the Society. The

e-library is a home for various materials such as videos from our events (Masterclass, Annual Meeting, webinars etc), podcasts, abstract books and the “living textbook” Virtual Vascular, with chapters written by the leading experts in the field published every month. Fifteen chapters have already been published and others are coming soon, including: Vascular Imaging, Late complications and surveillance after EVAR, Iliac artery aneurysms, and many others. The e-library will continue to grow its offer in the future, with the development of new e-learning courses in 2022. The e-library is accessible to ESVS members and individual subscribers. ESVS membership also grants you free access to the European Journal of Vascular and Endovascular Surgery (EJVES), the leading vascular surgery journal with a record Impact Factor of 7.069, as well as discounts to our events, workshops and publication on EJVES Vascular Forum, among other benefits. Join our community of +2,500 vascular surgeons and healthcare professionals in Europe and across the globe!

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AORTIC VIENNA CLASSICAL OPEN AND ENDOVASCULAR SOLUTIONS

CARDIAC, VASCULAR AND ENDOVASCULAR AORTIC ADVANCES C

5 – 7 O C T O B E R 2 0 21

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September 2021 | Issue 91

34 Market Watch

Clinical News R3 Vascular reports the initiation of its first-in-human clinical study

R3 Vascular has reported the successful initiation of its first-in-human clinical study evaluating the technical and clinical performance of the R3 Vascular Magnitude bioresorbable sirolimuseluting scaffold (BRS) in patients suffering from chronic limbthreatening ischaemia (CLTI) due to occlusive below-the-knee (BTK) arterial disease. A press release details that the R3 Vascular platform incorporates an innovative scaffold design and bioresorbable polymer technology resulting in biomechanical performance comparable to metallic stents. At a 98-micron strut thickness across its usable range of diameters, the Magnitude BRS device is the thinnest BRS ever tested in this clinical setting, the release adds. “Given the dire and unmet clinical need of patients presenting with CLTI undergoing BTK revascularisation, we are extremely pleased by the rapid progression of our programme,” said R3 Vascular CEO Kamal Ramzipoor. “Our Magnitude BRS is well-positioned to improve the clinical outcomes of these patients by providing temporary mechanical support and sustained drug delivery while reducing the wellestablished complications associated with permanent implants.” “In this early clinical experience, we successfully tested the deliverability and mechanical performance of the Magnitude BRS. Postprocedural angiographic and duplex ultrasound data confirm the mechanical properties and ‘stent-like’ results of the Magnitude BRS device in presence of a highdisease burden. We are looking forward to expanding the patient population cohort and following the clinical results over time,” said Marianne Brodman (Medical University of Graz, Graz, Austria). Juan F Granada, a strategic advisor to R3 Vascular, added: “In BTK intervention, the prevention of vessel recoil following balloon dilatation is key to preventing negative remodelling and maintaining vessel patency over time. BRS offer the best of both worlds by providing vessel support while it is needed and allowing the opportunity for future reinterventions, which is important in this type of patient. The successful validation of this technology may finally offer an effective and durable way to treat patients with this complex medical condition.”

multicentre early feasibility study of the Impede-FX RapidFill device when used for abdominal aortic aneurysm (AAA) sac management during elective endovascular aneurysm repair (EVAR). The Dutch study’s first procedure was performed by Michel Reijnen, vascular surgeon at Rijnstate Hospital in Arnhem, The Netherlands. Ted Ruppel, president and chief executive officer of Shape Memory Medical said: “We would like to congratulate Michel Reijnen and the clinical study team at Rijnstate Hospital for a successful first AAA-SHAPE case in The Netherlands. The addition of Dutch sites to the AAA-SHAPE programme accelerates our ability to evaluate Impede-FX RapidFill and its potential to improve sac regression in AAA patients following EVAR.” The study will enrol up to 15 patients across three centres in The Netherlands, contributing to the AAA-SHAPE safety study, which is also currently enrolling up to 15 patients in Auckland, New Zealand. The Impede-FX RapidFill device contains five Impede-FX, 12mm embolisation plugs preloaded into a single delivery introducer for fast and efficient delivery of the embolic material. This high-volume platform incorporates the novel Shape Memory Polymer, a porous, embolic scaffold that is crimped for catheter delivery and selfexpands upon contact with blood for rapid conversion to organised thrombus. Preclinical and clinical studies have shown that Shape Memory Polymer offers effective and predictable space filling, stable clot formation for sac embolisation, and progressive healing as the material biodegrades. “We are excited to contribute to AAA-SHAPE,” said Reijnen, principal investigator for AAA-SHAPE Netherlands. “Patients who develop aneurysm sac shrinkage following EVAR have better outcomes than patients with a stable or growing aneurysm sac. We look forward to learning how the use of Impede-FX RapidFill in combination with EVAR influences sac behaviour,” continued Reijnen. “We are very pleased to be working together with colleagues from the Netherlands to add to our growing experience with AAA-SHAPE,” said Andrew Holden, interventional

First patient enrolled in Shape Memory Medical’s AAASHAPE Netherlands study Shape Memory Medical has announced the initiation of AAA-SHAPE Netherlands, the company’s prospective,

AAA sac fill (left) with Impede-FX RapidFill implants (right)

radiologist at Auckland City Hospital in Auckland, New Zealand. “Our preliminary experience with AAASHAPE has been very encouraging, and the first few patients have shown a reduction in AAA sac diameter at early follow-up,” continued Holden.

PRISTINE registry with Selution SLR sirolimus drugeluting balloon completes enrolment

MedAlliance has announced completion of patient enrolment in the PRISTINE clinical trial with the Selution SLR 018 drug-eluting balloon (DEB) for the treatment of patients with below-theknee (BTK) disease. According to a MedAlliance press release, Selution SLR is the first DEB to be awarded Breakthrough Device designation by the US Food and Drug Administration (FDA).

Selution SLR

The objective of the prospective PRISTINE trial is to evaluate the safety and efficacy of the Selution SLR sirolimus DEB in the treatment of infra-inguinal occlusive lesions (TASC C and D) in patients with chronic limbthreatening ischaemia in 75 patients over 12 months at Singapore General Hospital in Singapore. PRISTINE is a follow-up registry to the PRESTIGE trial. The 12-month data from PRESTIGE were presented at LINC 2021 (The Leipzig Interventional Course, 25–29 January, online), showing sustained benefits up to one year. Eighteen-month data are to be presented at VIVA 2021 (Vascular InterVentional Advances; 4–7 October, Las Vegas, USA), where it is anticipated that these benefits will be further sustained. A similar outcome benefit is expected from PRISTINE in a larger real-world population. “One of the important things to note is that we had few exclusion criteria, unlike many of the randomised controlled trials using drug-coated balloons in the peripheral vasculature, and the data represent real-life lesions that we face every day as vascular specialists in Singapore”, said lead investigator Tjun Yip Tang (Singapore General Hospital, Singapore). “PRISTINE will offer further insight, leveraging our initial experience with the PRESTIGE trial, into whether this sirolimus-eluting balloon will become an established device in our angioplasty armamentarium to fight the neointimal hyperplasia effect and restenosis phenomenon that lead to a significant number of clinically driven target lesion revascularisations in the BTK arteries,

in this frail and challenging cohort of patients, whose ischaemic foot wounds are difficult to heal.” In February 2020, MedAlliance received CE mark approval for Selution SLR in the treatment of peripheral arterial disease (PAD) and in May 2020 received CE mark approval for treatment in coronary arterial disease (CAD). MedAlliance has been awarded FDA Breakthrough designation for the Selution SLR for use in BTK and expects to begin the investigation device exemption (IDE) study later this year.

Boston Scientific initiates randomised controlled trial for the EkoSonic endovascular system Boston Scientific has commenced enrolment in the HI-PEITHO clinical trial, a collaborative research study with the Pulmonary Embolism Response Team (PERT) Consortium and the University Medical Center of the Johannes Gutenberg University of Mainz (Mainz, Germany) comparing use of the EkoSonic endovascular system (EKOS) in combination with anticoagulation to anticoagulation alone for the treatment of acute, intermediatehigh-risk pulmonary embolism (PE). The EKOS system uses ultrasound energy in combination with a thrombolytic drug to dissolve blood clots and restore blood flow in patients with PE and peripheral arterial occlusions. According to a company press release, the ultrasound technology used by the EKOS system accelerates thrombolysis, minimising the time it takes to treat a patient and lowering the necessary thrombolytic dose, which can result in optimised outcomes and a lower risk of bleeding. “I am honoured to be part of this study’s global leadership whose mission is to bring forth guidelineinforming data that will ensure physicians can feel confident in the most appropriate strategy for treating patients with intermediate-high-risk PE,” said Stavros Konstantinides (University Medical Center of the Johannes Gutenberg University of Mainz, Mainz, Germany), study co-lead principal investigator. The randomised HI-PEITHO trial will enrol up to 544 patients with confirmed acute, intermediate-high-risk PE at as many as 65 sites in the USA and Europe. The trial, which will follow patients for one year, will assess whether treatment with the EKOS system in combination with anticoagulation is associated with a significant reduction in adverse events compared to anticoagulation alone,

EkoSonic endovascular system

Issue 91 | September 2021

Market Watch 35

Clinical News within seven days of randomisation. The composite primary endpoint is defined as PE-related mortality, cardiorespiratory decompensation or collapse, and non-fatal symptomatic and objectively confirmed recurrence of PE. “Optimal treatment of PE is still poorly understood and there is a need for a coordinated institutional approach to this complex, lifethreatening problem,” said Kenneth Rosenfield (Massachusetts General Hospital, Boston, USA), study colead principal investigator. “The lead investigators of the trial are pleased to collaborate with the PERT Consortium, which is committed to evidence-driven therapy and is proud to take part in the HI-PEITHO study, aiming to advance the care of patients with PE.”

Artio Medical completes enrolment of first-in-human trial investigating Amplifi vein dilation system

Artio Medical announced today it has completed enrolment in its first-in-human study evaluating the Amplifi vein dilation system. In the study, five patients were treated by Adrian Ebner, head of the Cardiovascular Department at Sanatorio Italiano Hospital in Asunción, Paraguay. “I am very pleased with my initial experience using the Amplifi system,” Ebner said. “The device was simple to implant and well-tolerated by all patients. We observed significant vein enlargement in each enrolled patient and were able to successfully create arteriovenous (AV) fistulas in all patients after treatment, including patients who were poor candidates for AV fistula before treatment.” The Amplifi system is designed to stimulate arm vein enlargement in haemodialysis patients using rapid, non-pulsatile venous blood flow. After seven days of treatment, the device is removed during surgery to create an AV fistula. The Amplifi vein dilation system aims to make more haemodialysis patients eligible to receive an AV fistula, increase fistula maturation success, reduce maturation time, and prolong the usable life of these fistulas. Amplifi is the first and only medical device intended to dilate and prepare veins prior to AV fistula surgery, according to an Artio Medical press release. “I am grateful for Dr Ebner and the entire team at Sanatorio Italiano who contributed to the success of this first-in-human study,” said F Nicholas Franano, president and CEO of Artio Medical. “The company looks forward to sharing data on these first five patients in the coming months and building upon this promising early clinical experience. We remain focused on delivering a much-needed solution to the millions of patients worldwide who need haemodialysis.”

LimFlow system a ‘costeffective and high-value alternative’ to traditional therapies

Percutaneous Deep Vein Arterialisation (pDVA) with the LimFlow system offers a cost-effective and high-value alternative to traditional therapies or amputation, according to a recent study published in the Journal of Critical Limb Ischemia. Peter Schneider, professor of surgery at the University of California (San Francisco, USA) and co-author of the published article, said: “The cost-effectiveness analysis builds on recently published 12-month data from the PROMISE I study by showing that pDVA with the LimFlow system can be a high-value therapy alternative to the status quo for no-option CLTI patients. “This research highlights the health economic benefits of reducing amputations and the need to offer patients a better alternative worldwide.” The findings highlighted significant and promising data from costeffectiveness analysis comparing pDVA with the LimFlow system to the status quo treatment for no-option CLTI patients, according to the study authors. The status quo was defined by a meta-analysis conducted by the Yale Cardiovascular Research Group on no-option patient outcomes from other reputable studies ranging from 2006 to 2018, which is pending publication in the Journal of Critical Limb Ischemia.

The comparative analysis demonstrates that expected outcome improvements with pDVA justify its incremental costs and qualifies it as a “high-value” therapy per established willingness-to-pay thresholds. Dan Rose, CEO of LimFlow, added: “Avoiding major amputation is a key treatment goal in CLTI due to its associated high costs, loss of functional status and quality of life, and high mortality. “The analysis using data from PROMISE I demonstrates our technology can provide significant clinical and health-economic value to patients and healthcare providers who are drastically underserved by the status quo.”

Concept Medical provides update on IMPRESSION trial to evaluate MagicTouch AVF

Concept Medical has provided an update on the progress of the IMPRESSION (Sirolimus-coated balloon angioplasty versus plain balloon angioplasty in the treatment of dialysis access dysfunction) trial—a prospective, multicentre, two-arm parallel group, randomised clinical study designed to assess the efficacy of its MagicTouch AVF sirolimuscoated balloon in treating dysfunctional fistulas. The IMPRESSION trial will compare the efficacy of the sirolimuscoated balloon versus a placebo plain balloon—the control arm—in the treatment of dysfunctional, or stenosed, arteriovenous fistulas (AVFs) used for vascular access in haemodialysis. A total of 170 patients with endstage renal disease (ESRD) are being

randomised in a 1:1 fashion between the two groups—and only ESRD patients with a matured dysfunctional AVF that has been in use for at least one month prior to angioplasty will be enrolled. The study’s primary objective is to determine if the use of a sirolimuscoated balloon will result in an improvement in primary circuit patency at six months when compared with plain balloon angioplasty. The index patient was enrolled on 11 January 2021 and—at time of writing—37 patients have been enrolled in the IMPRESSION trial. The trial is being conducted at three sites in Singapore, led by Chieh Suai Tan (Department of Renal Medicine, Singapore General Hospital [SGH], Singapore). Other site principal investigators include Edward Choke (Department of Surgery, Sengkang General Hospital, Singapore) and Jackie Ho (Department of Cardiac, Thoracic and Vascular Surgery, National University Heart Centre, Singapore). According to a Concept Medical press release, SGH was chosen to lead this randomised controlled trial because of its prior experience using sirolimuscoated balloons in two investigatorinitiated pilot studies. The studies had shown that patency rates associated with the use of the MagicTouch AVF in thrombosed arteriovenous grafts (AVGs) and dysfunctional AVFs were 65% and 82.9% at six months, respectively. The MagicTouch AVF has already been granted Breakthrough Device designation by the US Food and Drug Administration (FDA)—receiving this designation in August 2019.

Vascular surgeons take on cycle challenge in aid of the Circulation Foundation

In October this year, a team of vascular surgeons, nurses, and healthcare scientists will take on a 185-mile cycle challenge through the Outer Hebrides Islands off the coast of Scotland, UK, in a bid to raise awareness and funding for the Circulation Foundation. ESTABLISHED IN 1992, THE CIRCULATION Foundation is the charitable foundation of the Vascular Society of Great Britain and Ireland (VSGBI), and works to fund and promote research into the causes, prevention and treatment of vascular disease. According to the Foundation, vascular disease is as common as cancer and heart disease, and accounts for 40% of deaths in the UK. The Foundation’s vision is a society free of vascular disease and its associated suffering. Despite the COVID-19 pandemic and heavy workloads, the cycling team is committed to taking on the Outer Hebrides challenge to raise awareness and gain support for their often under-represented patients with vascular disease. VSGBI president Michael Jenkins (Imperial College Healthcare NHS Foundation Trust, London, UK) considers the challenge ahead: “When Chris (Imray) and I first thought of doing this, we had no idea it was a recognised cycle route! Once we realised it was and began talking about it, we realised others were interested and we now have a group including members from most of our allied vascular societies—vascular nursing, vascular scientists and vascular anaesthetists. The original plan was a sunny Spring venture, but COVID-19 put pay to that so now we are venturing out in (likely to be not-so-sunny) October… So, even more reason to sponsor us as the first of the

Autumn gales roll in from the Atlantic! The Circulation Foundation and all our patients will benefit.” All funds raised will go towards the funding and promotion of research into the causes, prevention, and treatment of vascular disease. To donate, please visit https://www.justgiving.com/ fundraising/circulationfoundation-outerhebrideschallenge. To find out more about the Circulation Foundation, please visit https://www.circulationfoundation.org.uk/.

Specialised source of news and education in the field of renal disease management Breaking news, in-depth analysis, and leading opinion from key industry figures Steered by globally-renowned physicians to monitor the latest innovations and controversies alike in the kidney care field Industry updates and real-time event coverage via social media, videos and more on print and digital platforms Visit www.renalinterventions.net and click ‘Subscriptions’ for complimentary print subscription* and e-newsletter subscription** *Available for US and EU readers only **Available worldwide

Issue 91 | September 2021

Market Watch 37

Product News Medtronic receives CE mark for 200mm and 250mm IN.PACT Admiral DCBs

Medtronic has announced CE mark approval and the European launch of the 200mm and 250mm IN.PACT Admiral drug-coated balloons (DCBs). The product is intended to treat long complex femoropopliteal lesions efficiently in patients with peripheral arterial disease (PAD). The 200mm and 250mm IN.PACT Admiral DCB enables physicians to treat longer lesions using a single DCB instead of multiple DCBs. Thomas Zeller, director of the Department of Angiology at Universitaets-Herzzentrum, FreiburgBad Krozingen, Germany, performed the first case using the new sizes of the IN.PACT Admiral DCB in Europe. He stated: “Patients with SFA [superficial femoral artery] disease often present with longer and more complex lesions as time goes on, which makes it challenging to effectively treat the

IN.PACT Admiral – 250mm, 200mm and 150mm

entire segment. We know the IN.PACT Admiral DCB is effective in providing durable results, and now with the longer sizes, it is a more efficient treatment option for these difficult to treat lesions. Using the new sizes of the IN.PACT Admiral DCB could potentially lead to saving both time and money by using one balloon instead of multiple balloons.” About the IN.PACT Admiral DCB: The IN.PACT Admiral DCB is a clinically established, primary endovascular therapy, which has been shown to provided durable, consistent and safe outcomes across multiple clinical trials, as well as across complex patient and lesion types. With more than 3,500 patients enrolled in 21 clinical studies and 600,000+ patients treated worldwide, the IN.PACT Admiral DCB is the preferred DCB for treatment of femoropopliteal disease allowing reduced interventions and preserving future treatment options. A DCB’s primary mode of action is physical dilatation of the vessel lumen by percutaneous transluminal angioplasty (PTA), followed by the delivery of paclitaxel. The unique formulation of IN.PACT Admiral DCB with its drug dose, excipient and crystallinity, provides sustained drug residence in the tissue, leading to an effective and durable outcome.

The 200mm and 250mm IN.PACT Admiral DCBs received FDA approval in May of 2018.

FDA approves expanded PAD indication for Xarelto plus aspirin to include patients after LER due to symptomatic PAD

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the US Food and Drug Administration (FDA) has approved an expanded peripheral arterial disease (PAD) indication for the Xarelto (rivaroxaban) vascular dose (2.5mg twice daily plus aspirin 100mg once daily) to include patients following recent lower-extremity revascularisation (LER) due to symptomatic PAD. The approval is based on data from the Phase III VOYAGER PAD study. According to a press release, Xarelto is now the first and only therapy indicated to help reduce the risks of major cardiovascular events in patients with coronary artery disease (CAD) and major thrombotic vascular events, such as myocardial infarction, ischaemic stroke, acute limb ischaemia, and major amputation of a vascular aetiology, in patients with PAD, including patients who have recently undergone LER due to symptomatic PAD. “For more than 20 years, many physicians have used dual antiplatelet therapy after lower extremity revascularisation due to symptomatic PAD with limited data to support efficacy and safety in this setting. Now, the VOYAGER PAD and COMPASS clinical studies have demonstrated the utility of dual pathway inhibition in targeting both platelets and thrombin in patients with PAD. These data provide a new mechanism of treatment using an evidence-based strategy for this vulnerable population,” said Marc P Bonaca (University of Colorado Anschutz Medical Campus, Aurora, USA). “This FDA approval of rivaroxaban plus aspirin is a major advancement for PAD management and sets the stage to evolve the current standard of care for patients with PAD.” Xarelto now has nine indications in the USA. Today’s approval is based on the Phase III VOYAGER PAD trial, which demonstrated the Xarelto vascular dose (2.5mg twice daily plus aspirin

Xarelto (rivaroxaban)

100mg once daily) reduced the risk of major adverse limb and cardiovascular

events by 15% in patients with symptomatic PAD post-LER compared to aspirin alone. The VOYAGER PAD trial saw no significant difference in thrombolysis in myocardial infarction (TIMI) major bleeding between Xarelto with aspirin compared to aspirin alone. The results from the VOYAGER PAD study complement findings from the landmark Phase III COMPASS trial, which also examined the dual pathway approach of Xarelto with aspirin in CAD and/or PAD patients and further supports this FDA label extension in PAD patients. Data from the Phase III COMPASS trial resulted in FDA approval in 2018 to reduce the risk of major cardiovascular events, such as heart attack, stroke and cardiovascular death in people with chronic PAD and CAD. While there were more major bleeds with the Xarelto vascular dose in COMPASS, there was no significant difference in rates of fatal bleeding, intracranial bleeding or symptomatic bleeding into a critical organ.

Terumo Aortic announces US FDA approval for RelayPro endovascular device Terumo Aortic has announced that the US Food and Drug Administration (FDA) has granted approval of its RelayPro thoracic stent-graft system for sale in the USA for the treatment of patients with thoracic aortic aneurysms (TAA) and penetrating atherosclerotic ulcers (PAUs). The approval follows the successful completion of the RelayPro aneurysm study in the USA and Japan. This was a prospective, multicentre, non-blinded, non-randomised study of the RelayPro thoracic stent-graft in 110 patients with thoracic aneurysms and PAUs in the descending aorta. RelayPro is a low profile, nextgeneration thoracic stent-graft device designed to expand the treatment of

RelayPro

thoracic endovascular aortic repair (TEVAR) to patients with smaller access vessels. The platform utilises the same stent design, materials and foundational dual sheath technology of the RelayPlus system; with a three to four French reduction in outer profile, RelayPro delivers the accuracy, control and confidence of RelayPlus without compromising device integrity and durability, say Terumo Aortic. Wilson Szeto, chief of cardiovascular surgery at Penn Presbyterian University of Pennsylvania Health System (Philadelphia, USA), and co-national principal investigator of the study: said: “RelayPro’s ability to navigate smoothly over the arch as a result of the

Dual Sheath system enables accurate deployment, and combined with the low profile of the device, this allows me to successfully treat complex anatomy with precision.” A company press release also states that the RelayPro is the only lower profile device with a non-bare stent design available in the United States to treat aneurysms and penetrating atherosclerotic ulcers. Paul Kuznik, president of Terumo Aortic North America, added: “This announcement represents a significant opportunity for Terumo Aortic in the USA further complementing our abdominal endovascular and open surgical graft portfolio, as well as expanding our range of products to treat thoracic aortic aneurysms. We are committed to providing physicians with innovative aortic solutions for the treatment of their patients.” “One of the key features and benefits of RelayPro is being able to choose from a range of sizes and tapers, allowing me to tailor my device selection to meet the individual needs of each patient and adapt to complex anatomy and morphology,” said co-National principal investigator Venkatesh G Ramaiah (chief of Vascular and Endovascular Surgery Honor Health Network, Scottsdale, USA) “In addition, the unique delivery system, the low profile, and the options of bare stent and non-bare stent are clear differentiators. This is a landmark advancement in the endovascular treatment of thoracic aneurysms.” RelayPro received CE mark approval in 2017.

Surmodics announces successful first patient use of Pounce thrombectomy system

Surmodics has announced that J Michael Bacharach, a vascular interventionalist/ cardiologist at North Central Heart, a division of Avera Heart Hospital in Sioux Falls, USA, successfully treated the first patient with the company’s Pounce thrombectomy system. The procedure involved a patient presenting with increasing pain in the left leg and was diagnosed with an occluded superficial femoral artery (SFA). Three passes of the Pounce device removed 30cm of subacute thrombus and blood flow was successfully restored. Eight additional cases have since been performed in the USA with positive outcomes reported following each procedure. “Despite the challenge presented by this particular case, I could not have asked for anything more. The device’s performance was really amazing,” said Bacharach. “I was able to safely and effectively achieve a positive outcome for this patient with minimal blood loss and without the use of thrombolytics. I am very excited about the results of this case. I am a believer in the Pounce system.” The Pounce Thrombectomy System received US Food and Drug Administration 510(k) clearance in September 2020.

September 2021 | Issue 91

38 Market Watch Jeti Registry. Both the Jeti peripheral thrombectomy systems have received 510(k) clearance from the US Food and Drug Administration (FDA) for the aspiration and breaking up of soft emboli and thrombus from the peripheral vasculature, as well as CE mark in Europe and approvals in other countries.

Industry News Abbott expands peripheral vascular offerings with acquisition of Walk Vascular

Abbott announced today that it has acquired Walk Vascular, a commercialstage medical device company with a minimally invasive mechanical aspiration thrombectomy system designed to remove peripheral blood clots. Walk Vascular’s peripheral thrombectomy systems will be incorporated into Abbott’s existing endovascular product portfolio. Financial terms were not disclosed. “The acquisition of Walk Vascular fits well into our leading vascular device offerings and further drives Abbott’s ability to provide one-of-a-

Jeti thrombectomy system

Surmodics builds thrombectomy portfolio with acquisition of Vetex Medical ReVene thrombectomy catheter

kind endovascular therapy solutions to improve patient care,” said Julie Tyler, senior vice president of Abbott’s vascular business. “Walk Vascular’s technology provides physicians with tools to efficiently remove dangerous clots from blood vessels to improve patient care.” Walk Vascular’s Jeti peripheral thrombectomy system and Jeti AIO (All In One) peripheral thrombectomy system are aspiration systems for the removal of thrombus. The Jeti systems are designed to break-up and remove clots from the peripheral vascular system while reducing the risk of dislodged clots. The systems are backed by real-world clinical experiences, and Walk is currently enrolling up to 250 patients in the USA and Europe in the

Surmodics recently announced that it has acquired privately-held Vetex Medical Limited. The Galway, Irelandbased medical device developer and manufacturer has focused exclusively on venous clot removal solutions. The transaction expands Surmodics’ thrombectomy portfolio with a second US Food and Drug Administration (FDA) 510(k)-cleared device, the ReVene thrombectomy catheter. The ReVene mechanical thrombectomy catheter is specifically designed to remove large, mixedmorphology blood clots commonly found with venous thromboembolism (VTE). According to a press release, the device’s dual action technology efficiently removes mixed-morphology clot in a single session, minimising the need for thrombolytics and without capital equipment. “This acquisition demonstrates our

Celt arterial closure device

commitment to the expansion of our thrombectomy platform to remove thrombus in venous vascular beds, with an exciting technology that offers significant improvements over current therapies,” said Gary Maharaj, president and chief executive officer of Surmodics. “The ReVene thrombectomy catheter has the potential to significantly expand the use and accessibility of venous mechanical thrombectomy by allowing physicians to intervene early and complete the procedure in a single session,” said Stephen Black (Guy’s and St Thomas’ NHS Foundation Trust, London, UK), principal investigator and leading enroller of the VETEX feasibility study. “The ease of use, intuitive design, and efficient performance of this device enables it to become the first-line treatment and a confident choice by venous interventionalists.”

Calendar of events 25–28 September Cardiovascular and Interventional Radiological Society of Europe (CIRSE) Annual Meeting 2021 Online

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.cirse.org.events/cirse2021

28–29 September European Society for Vascular Surgery (ESVS) 35th Hybrid Annual Meeting Rotterdam, The Netherlands and online

www.esvs.org/events/35th-annual-meeting-2021

4–7 October VIVA: Vascular InterVentional Advances Las Vegas, USA

5–7 October CX Aortic Vienna Broadcast

www.cxsymposium.com/cxaortic

21–23 October Paris Vascular Insights Paris, France

www.parisvascularinsights.com

16–20 November VEITHsymposium 2021 Orlando, USA

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

www.vascularsociety.org.uk/vsasm_2021.aspx

2–4 December VERVE Symposium Sydney, Australia

www.vervesymposium.com

www.veithsymposium.org

www.vivaphysicians.org/future-meetings

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