November 2020 | Issue 88
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Paclitaxel: Vascular surgeons encouraged to consult talking points
Profile: Chris Imray
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Rebecka Hultgren: Aortic disease in women and men
Second COVID-19 wave conveys continuing uncertainty for vascular surgery As 2020 draws to a close, many countries across the globe face continuing challenges arising from COVID-19. At this year’s European Society for Vascular Surgery (ESVS) annual meeting, held virtually as biweekly webinars as ESVS Month (29 September–29 October), the organisation of hospitals during the pandemic was on the agenda. Speakers from Finland, Germany, Italy, and the UK detailed the situation in their respective countries, providing a snapshot of vascular surgery over the past nine months, sharing key details and learnings, and considering what lies ahead.
“W
e do not have a common strategy for all the hospitals in Finland, but all hospital districts have their own plan,” began Maarit Venermo (Helsinki University Hospital and University of Helsinki, Helsinki, Finland), who detailed the organisation in the biggest hospital district in Finland—Helsinki, Uusimaa. Venermo noted that the number of cases in Finland so far has been relatively low compared to the other countries being discussed during the ESVS webinar, citing fewer inhabitants as one of the reasons. While the population of Finland is 5.5 million, those of the UK, Italy, and Germany are at least 10 times higher, at 68 million, 60 million, and 84 million, respectively. “Maybe there is a natural distancing,” Venermo suggested. Addressing online viewers, Venermo explained that additional staff training was implemented for those treating COVID-19 patients. In the emergency clinic, for example, the workforce received training on identifying acute respiratory failure, assessing the need for treatment, and starting treatment for COVID-19 patients. Regarding staff transfers, Venermo detailed that approximately 1,500 employees were reassigned to another unit, with the biggest staff transfers made from different departments/hospital areas to the drive-in testing stations and to inpatient and intensive care units treating COVID-19 patients. Considering the impact of the pandemic on nonCOVID-19 treatment, Venermo expressed concern. “How many aneurysm rupture patients did not seek care because of COVID-19?” she asked rhetorically, noting that there was a dramatic decrease in the number of surgical operations performed from February to April 2020. In addition, Venermo reported that the total number of appointments was around 100,000 less in the March and April 2020 compared to the same period the year previously. In conclusion, the first wave of COVID-19 in Finland was managed “successfully,” Venermo relayed, with Helsinki and Uusimaa hospitals able to arrange the appropriate facilities quickly, and there being more than enough capacity for COVID-19 patients. “Only the future will show us how serious the second wave will be,” Venermo postulated, ending on the note that analysis of the damage caused by COVID-19 is yet to
How many aneurysm rupture patients did not seek care because of COVID-19?.” come, and, “we may never find out” the consequences for those needing treatment for reasons other than COVID-19.
Germany: A timeline of events
Next to speak was Eike Sebastian Debus (University Heart & Vascular Center Hamburg-Eppendorf, Hamburg, Germany), who informed online viewers about the organisation of hospitals in Germany, focusing on his centre in particular, during the pandemic. Debus detailed the situation via a timeline, first detailing the situation in the country as a whole, before honing in on the University Heart & Vascular Center HamburgEppendorf. For the hospital, the timeline began in January, with an early emphasis on testing. Debus detailed that the microbiology laboratory in the hospital began to offer daily COVID-19 virus diagnostics. Then, in February, the Institute for Medical Microbiology, Virology and Hygiene was able to detect the virus in a sample within a few hours, which coincided with the first case of a COVID-19 infection in Hamburg. A daily COVID-19 task force was initiated, and in March a series of clinical research projects were started. These included the Hamburg City Health Study, in which adults and children were tested for antibodies. Continued on page 4
“Starting to close the door on the paclitaxel controversy”: Late-breaking trials presented at TCT 2020 Findings from a series of latebreaking trials in the endovascular field were presented recently at TCT Connect (14–18 October, virtual), the 32nd annual scientific symposium of the Cardiovascular Research Foundation (CRF). Sahil A Parikh (Columbia University Medical Center, New York, USA) and Frank Veith (New York University Medical Center, New York, USA) moderated the session, with Marc Bonaca (University of Colorado, Aurora, USA) and Robert A Lookstein (Mount Sinai Health System, New York, USA) on the panel. FIRST ON THE VIRTUAL PODIUM was Connie N Hess (University of Colorado, Aurora, USA), who presented the results from a large subgroup analysis of the VOYAGER PAD randomised clinical trial. This showed neither a mortality risk nor benefit associated with the use of paclitaxel drug-coated devices in the treatment of peripheral arterial disease (PAD). The study also found that the benefit of rivaroxaban use on reducing ischaemic limb and cardiovascular outcomes was consistent regardless of whether a drug-coated device was used. Hess and team’s analysis examined the long-term safety of drug-coated devices (DCDs). It also evaluated whether rivaroxaban 2.5mg twice daily plus low dose aspirin versus low dose aspirin alone was consistent, either with or without use of a DCD. During the qualifying endovascular lower extremity revascularisation, DCD was used for 31% (n=1,358) of patients. Patients receiving DCD more frequently had prior endovascular lower extremity revascularisation, had higher baseline use of dual antiplatelet therapy and statins, and were more often treated for claudication than non-DCD patients. In the unweighted analysis, lower associated Continued on page 6
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November 2020 | Issue 88
Top story
Second COVID-19 wave conveys uncertainty for vascular surgery Continued from page 1
In April, the Clinic for Intensive Care Medicine (KIM) was built, with 154 beds. This was to be maintained until the end of May, at which time a vaccine study began. In August, wearing a face mask in the hospital became mandatory, and it was announced that visiting doctors, students, and interns were not allowed to work at the hospital until the end of the month. “Cases are rising in Germany,” Debus said, adding that an increase of infected patients is expected imminently at the University Heart & Vascular Center Hamburg-Eppendorf. He ended with a note of uncertainty: “We do not know how things will develop further”.
Maintenance of elective vascular surgery is possible, Italian study finds
Describing the situation in Italy, Mauro Gargiulo (University of Bologna and University Hospital Policlinico S Orsola, Bologna, Italy) was next to speak. He outlined a report from the Italian Society of Vascular Surgery (SICVE) on the impact of the COVID-19 pandemic on the activities of vascular surgery in the country, detailing results of prospective data from 154 units of vascular surgery collected weekly from 30 March–5 April. Gargiulo reported that in the first week there was an 80% reduction of beds and an 84% reduction of operating rooms for elective surgical activities. In addition, 43% of hospitals were conducting no elective surgery, with only 5% reporting no reduction of elective surgery. Then, Gargiulo spoke about the impact of the pandemic on the activities of the Metropolitan Unit of Vascular Surgery in Bologna (Emilia-Romagna region). He noted that Emilia-Romagna had second highest level of documented cases of COVID-19 infections in Italy, after Lombardy. The healthcare system of the city of Bologna maintained elective surgical activities of cardiac, oncological, and vascular surgery, he reported. Gargiulo reported that in the period of the Pandemic the Metropolitan Vascular Surgery of Bologna worked on two tertiary hospitals in the Bologna, which offered service for five peripheral hospitals. In a study recently published in the European Journal of Vascular and Endovascular Surgery, Gargiulo and colleagues set out to evaluate the protocols for COVID-19 infection prevention and surgery activities. The research team asked the question: Is it possible to safely maintain elective vascular surgery activity during the COVID-19 pandemic? According to the experience of the Metropolitan Unit of Vascular Surgery at the University of Bologna, the answer is ‘yes’, if an efficient safety protocol can be set to minimise the risk of infections for patients and
physicians, and the choice of elective surgical intervention is one with a low impact on hospital resources and scarce or no need for postoperative intensive care.
News in brief
Concern from London: “We have no idea how much trouble we are in now”
Opening a presentation on the organisation of hospitals in the UK during COVID-19, Mark Tyrrell (Guy’s and St Thomas’ NHS Foundation Trust, London, UK) highlighted a specific problem: “the ‘United’ Kingdom is not a single, homogenous entity”. In fact, the UK comprises four distinct, semi-autonomous countries, with a mix of urban and rural areas, and “huge wealth disparity,” he told viewers. In addition, “the current model of distribution of vascular care means that it really is not possible to accurately describe one response and one outcome,” Tyrrell explained. In the UK, vascular surgery is centralised and operated under a “Hub and Spoke” model, consisting of mainly city centre Hubs and town centre Spokes. “What I am going to share is very London-centric,” Tyrrell specified, informing ESVS webinar viewers that if they need a wider UK view, there are various reports on the
We may never find out the consequences for those needing treatment for reasons other than COVID-19.” Vascular Society for Great Britain and Ireland website. Tyrrell detailed that at St Thomas’ Hospital in London, vascular operating sessions fell from 15 per day plus emergencies to two per day in total. Emergencies were dealt with on the main site, but not electives; an off-site COVID-19-free service for urgent electives was established at London Bridge Hospital. Thresholds to surgery were reset, and a rigorous multidisciplinary daily meeting process was initiated to prioritise cases. Patient clinics stopped, with telephone clinics introduced as a replacement, and the Emergency Vascular Clinic moved to Guy’s Hospital. Tyrrell detailed that all elective surgery stopped, and that emergency activity fell “precipitously”. In the period from March through to June, there were six consecutive days with zero admissions and 37 total days with zero admissions. Three ruptured aortic aneurysms were turned down due to no capacity during this period, Tyrrell relayed. Ending his presentation, Tyrrell expressed concern due to a national knowledge deficit based on “virtually non-existent” antigen testing and “initially non-existent” antibody testing. Because of this knowledge deficit, “we have no idea how much trouble we are in now.”.
The latest stories from the vascular world
n PACLITAXEL: Vascular surgeons are being encouraged to take consideration of a set of talking points about the risks and benefits of paclitaxel devices—which has been developed by the Multi-Specialty and MultiSociety Coalition for Patient Safety With Paclitaxel Technologies—in discussions with their patients.
For more on this story go to page 12. n BRIDGING STENTS IN BEVAR: In an advertorial sponsored by Bentley, Vascular News speaks to coordinating investigator of the company's trial into the use of bridging stents in branched endovascular aneurysm repair (BEVAR) procedures, Martin Austermann (Münster, Germany). Austermann details his excitement that the trial will being much-needed evidence into the equation, and his belief that solid data will move the field closer to realising an ideal briding stent.
For more on this story go to page 19. n NEW GENETIC FACTORS ASSOCIATED WITH AAA RISK: The American Heart Association (AHA) recently announced the publication of a study identifying 14 new genes linked to an increased risk of abdominal aortic aneurysm (AAA). Previous studies have detected 10 locations in the human genome associated with potential risks. But this new work, published in the AHA's journal Circulation, more than doubled that number, to a total of 24 genetic factors associated with AAA.
For more on this story go to page 31.
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November 2020 | Issue 88
TCT 2020
“Starting to close the door on the paclitaxel controversy”: Late-breaking trials presented at TCT 2020 Continued from page 1
mortality was observed among patients receiving DCD versus non-DCD (2.9 vs. 3.9 per 100 patient-years; 3.5-year Kaplan-Meier cumulative incidence of 10.2% vs.13.8%). After weighting, there was no association between DCD use and mortality (3.5-year cumulative incidence 12.1% vs. 12.6%, HR 0.95, 95% CI 0.83-1.09, p=0.49). The benefit of rivaroxaban 2.5mg twice daily with aspirin compared to aspirin alone on reducing ischaemic limb and cardiovascular outcomes was also consistent regardless of whether a DCD was used. The VOYAGER PAD trial was funded by research grants to CPC Clinical Research from Bayer and Janssen.
angioplasty (PTA) control group (0.59±0.94mm versus 1.26±0.81mm, respectively, p=0.017), a 53% lower late lumen loss than the PTA control group. Using the classic late lumen loss method, subjects in the DCB group experienced lower late lumen loss compared to those in the PTA control group at nine months (0.89±0.77mm versus 1.31±0.72mm respectively, p=0.07 ), a 32% lower late lumen loss than the PTA control group. Historically, there has not been a DCB technologythat has demonstrated effectiveness in this vessel bed. According to a Medtronic press release, the data presented at TCT demonstrate that IN.PACT 0.014 may offer a clinical benefit in patients with CLI. The IN.PACT 0.014 DCB is an investigational device that is being evaluated in Europe. This device is not currently being evaluated in the USA.
IN.PACT 0.014 DCB may offer a clinical benefit in patients with CLI
Antonio Micari (University of Messina, Messina, Italy) presented first-ever results from Medtronic’s IN.PACT BTK study, a feasibility study assessing the safety and effectiveness of the company’s IN.PACT 0.014 drug-coated balloon (DCB) in critical limb ischaemia (CLI) patients with chronic total occlusion (CTO) in the infrapopliteal arteries. The IN.PACT BTK study is a prospective, multicentre, 1:1, randomised feasibility study assessing the safety and effectiveness of the IN.PACT 0.014 DCB, a 3.5μg/mm2 dose paclitaxel-coated balloon, versus conventional percutaneous transluminal angioplasty (PTA) for the treatment of CTOs in the infrapopliteal arteries. The study enrolled 50 patients at nine sites in Europe. At nine months, patients in the DCB group experienced a reduction in sub-segmental late lumen loss compared to those in the percutaneous transluminal
Clockwise from top left: Sahil A Parikh, Frank Veith, Marc Bonaca, Connie N Hess, and Robert A Lookstein
We are barely scratching the surface on drug-based delivery in the below knee circulation.”
TRIAL UPDATE
COVER study: Updates from the VERN group In March 2020, the Vascular and Endovascular Research Network (VERN) launched the COVID-19 vascular service (COVER) study that is aimed at capturing the impact of the pandemic on global vascular surgery. Over half a year on, co-lead Sandip Nandhra (Newcastle University, Newcastle, UK) gives an update on findings and progress. VERN IS A MULTIDISCIPLINARY research network that aims to advance vascular research through global collaboration. When it became apparent that the worldwide pandemic would heavily impact upon clinical and operative practice, VERN recognised the need to document this impact globally, using high-quality research methodology. We wanted to know how the pandemic would impact on patient care, clinical management, and training. The COVER study is a global prospective cohort study which used a variety of research methods to address these aims. This collaborative effort involved 251 centres across 53 countries.
The study is split into three tiers, which aimed to: (1) document the changes in vascular service delivery internationally using an online survey (thresholds for treatment, screening, staff redeployment); (2) record all vascular and endovascular interventions performed across a 12-week period during the COVID-19 pandemic and the outcomes following these procedures (in-hospital, short- and long-term) in all participating centres/countries; (3) document changes in how patients were managed during the pandemic when they presented to a vascular surgeon with any type of vascular pathology. Importantly, the study group
ILLUMENATE Global: Four-year results support durable long-term outcomes with the Stellarex DCB
Andrew Holden (Auckland City Hospital, Auckland, New Zealand) reported on late safety and efficacy outcomes for the low-dose Stellarex DCB (Philips) in de novo and restenotic femoropopliteal lesions from a large cohort. He revealed that four-year data from prospective, single-arm, multicentre ILLUMENATE Global trial show favourable safety and efficacy outcomes consistent with the ILLUMENATE randomised controlled trials, and also demonstrate similar efficacy in prespecified cohorts including different gender groups and diabetics. At four years, the rate of major target limb amputation was 0.8% and that of all-cause mortality was 8.1%. Clinically-driven target lesion revascularisation through four years was 75.6% at day 1,460 and the subgroup analysis revealed no difference in prespecified cohorts. “The ILLUMENATE Global study supports durable long-term outcomes with the Stellarex DCB and is applicable to a complex population,” Holden told the TCT audience. Later on in the session, Ehrin J Armstrong (UCHealth Heart and Vascular Center, Aurora, USA) presented results of the TANGO Registry, Catalin Toma (University of Pittsburgh, Pittsburgh, USA) presented results from the FLASH Registry, and Yu Sato (CVPath Institute, Gaithersburg, USA) gave the final presentation, on the anatomy of the human accessory renal artery peri-arterial renal sympathetic nerve for renal denervation.
Closing the door on the paclitaxel controversy
“I think we are really starting to close the door on the paclitaxel controversy,” Lookstein commented at the end of the session. “There is clearly a lot more work that needs to be done for paclitaxel below the knee and it is encouraging to see that there is going to be work on that,” he added. “We are barely scratching the surface on drug-based delivery in the below knee circulation, so there is a lot more work to do.”
recognises the dynamic nature of the pandemic worldwide and adapted quickly to capture additional information when needed. Clinical outcome data from the UK, Europe, and elsewhere have already been analysed and some have been published, with ongoing data capture in other areas of the world (e.g. Brazil) that are currently being affected by the pandemic. Tier 1 data, recently published in the British Journal of Surgery, highlight a marked reduction in operative work and vascular services offered to patients, such as screening programmes and outpatient clinics. This information is guiding policy decision-making in the UK. Future work will aim to analyse medium- and long-term data for operative and non-operative patients. Early Tier 2 results are undergoing peer-review: we will shortly report on in-patient mortality for more than 1,200 patients who had vascular procedures during the first wave between April and June 2020. Analysis of Tier 3 data is currently underway and will comprise some of the world’s only data regarding decision-making alterations to vascular care forced by
the pandemic related restrictions, policy, and resources with ongoing follow-up. Importantly, COVER follows the VERN collaborative authorship model, with all collaborators named on manuscripts as PubMed citable co-authors and is a methodologically sound prospective cohort study with detailed data collection tools and ethical approvals in place. Results will help us understand the impact of COVID-19 on vascular service provision, patient management, and outcomes in multiple countries at different stages of the pandemic. These data will be invaluable in informing the development of measures to help mitigate the impact of future peaks and/ or pandemics on patients, staff, and the healthcare service. Finally, on behalf of the COVER study team and VERN, I would like to thank all of our collaborators and partner originations across the globe. The author has no disclosures; the COVER Study was supported by a grant from the Vascular Society of Great Britain and Ireland (VSGBI) and has been adopted onto the National Institute for Health Research (NIHR) portfolio.
Issue 88 | November 2020
24-month AVeNEW study results: Covered stent angioplasty “statistically superior” to angioplasty alone in ESRD patients Against the backdrop of increasing end-stage renal disease (ESRD) prevalence in the USA, Bart Dolmatch (Portola Valley, USA) presented the 24-month results of the prospective, randomised controlled AVeNEW study at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2020 Symposium (12–15 September, virtual). THIS IS THE FIRST LEVEL ONE trial dedicated solely to assess the safety and efficacy of the Covera (BD) covered stent designed to treat stenosis in the arteriovenous fistula (AVF) access circuit, Dolmatch relayed. The two-year results showed statistically superior target lesion primary patency and AVF circuit primary patency with the use of the covered stent compared with angioplasty alone. Renal replacement is expensive, online attendees of the FIRST@CIRSE session heard, and largely achieved with haemodialysis using an AVF. However, Dolmatch explained how AVF stenosis interferes with efficient haemodialysis, leading physicians to try and find a treatment modality that reduces its
or the angioplasty with Covera covered stent group. The study met both its primary safety and efficacy endpoints: freedom from a primary safety event out to 30 days, and target lesion primary patency at six months, respectively. There was no significant difference in freedom from a primary safety event out to 30 days between the covered stent cohort and the angioplasty-alone cohort (95% and 96.4%, respectively; p=0.002). Target lesion primary patency at six months was “superb” and “statistically superior” in the covered stent group compared to angioplasty (78.7% and 47.9%, respectively; p<0.001). A 12-month exploratory subgroup analysis of target lesion primary
Fabrizio Fanelli and Bart Dolmatch at CIRSE 2020
were both superior in the covered stent group, while secondary patency was the same in both groups (91.4%). “Interestingly, all-cause death was lower in the covered stent group than the angioplasty group,” Dolmatch continued. “I am not sure if this is statistically significant, as we have not done that analysis yet, but it is a curious finding.” Looking specifically at freedom from loss of access circuit primary patency, he commented: “Access circuit patency for an AVF drops off regardless of which group you are in, and yet, at 24 months, there is a statistically superior outcome of circuit patency for the covered stent group compared to the angioplasty group [p=0.02].”
The AVeNEW trial is ongoing, with one more year of data collection and analysis ahead, to bring its total duration to three years.
This is the first Level One trial dedicated solely to assess the safety and efficacy of the Covera [BD] covered stent.”
SAVE registry evidences safety of Surfacer system Covera
occurrence. “Angioplasty has been our go-to for many years,” he said. “We know that the durability after angioplasty is OK, but the question is, can we improve upon angioplasty durability when treating fistula stenosis?” Enter the AVeNEW study, a prospective, multicentre, multinational clinical trial of 280 patients with stenotic AVFs and clinical AVF dysfunction. Patients were randomised 1:1 to either the percutaneous transluminal angioplasty (PTA) group,
patency revealed that, regardless of certain lesion characteristics, “a preferential, better outcome using the covered stent compared to angioplasty alone. A Kaplan-Meier plot showed that the freedom from loss of target lesion primary patency was superior shortly after implantation of the covered stent compared to angioplasty, and remained statistically better at all time points. Secondary outcomes were also better for the covered stent cohort, Dolmatch related. The index of patency function and mean access circuit reinterventions
The Surfacer Inside-Out access catheter system device (Bluegrass Vascular) is safe and effective for patients with thoracic central venous obstruction requiring central venous access. That is conclusion of the prospective, multicentre SAVE (Surfacer system to facilitate access in venous occlusions) registry, published recently in the Journal of Vascular and Interventional Radiology (JVIR). GÜRKAN SENGÖLGE (MEDICAL UNIVERSITY OF VIENNA, VIENNA, Austria), co-author on the paper details: “We gained access with Surfacer technology in over 98% of the cases.”. “The publication of the results of the SAVE registry expands and strengthens the clinical evidence confirming the role the Surfacer system has in helping to establish central venous access in patients with venous obstructions,” states Maurizio Gallieni (University of Milan, Milan, Italy), who was a co-lead author. The Surfacer system has received US Food and Drug Administration (FDA) de novo device clearance in the USA and is CE marked in Europe. Gürkan Sengölge
November 2020 | Issue 88
Study finds 3mm arteriotomy may be routinely utilised for brachiocephalic fistula creation In a recently-published study, Jeremy Crane (Imperial College Healthcare NHS Trust, Hammersmith Hospital, London, UK) and colleagues conclude that a 3mm-long arteriotomy may be routinely utilised for brachiocephalic fistula creation in an attempt to limit the incidence of steal syndrome, while maintaining clinical patency outcomes. “THE ARTERIOVENOUS FISTULA [AVF] IS the modality of choice for long-term haemodialysis access,” the Journal of Vascular Access (JVA) paper begins. The authors cite lower rates of access-related infection and improved patient and access survival when compared to other modalities such as arteriovenous grafts or longstanding tunnelled central venous catheters as the reasons behind why the AVF is the most popular modality for haemodialysis access. However, AVF formation is “not to be taken lightly,” Crane and colleagues warn, noting that dialysis access-associated steal syndrome (DASS) as an “important” and “potentially limb threatening” complication. They explain that the hallmarks of steal syndrome are symptoms and signs of peripheral vascular insufficiency within the limb distal to the AVF, which are often detected through a thorough clinical history and examination. They go on to describe the feasibility of routinely fashioning a brachiocephalic fistula utilising a 3mm-
long arteriotomy in an attempt to reduce the incidence of symptomatic steal syndrome, while maintaining clinical patency outcomes. Crane and colleagues describe the study as a retrospective analysis of prospectively collected clinical data from a single surgeon. They detail that they included all patients who underwent brachiocephalic fistula formation using a routine 3mm-long arteriotomy within Hammersmith Hospital between January 2017 and March 2018 in the study. Primary outcomes included primary failure, failure of maturation, secondary patency, and steal syndrome. Writing in JVA, Crane et al relay that 68 brachiocephalic AVFs were fashioned utilising a 3mm arteriotomy during study period, adding that the mean age was 60.5 years with 59% having a history of diabetes mellitus. The mean follow-up was 368 days, the authors write. The authors report that primary failure occured in 10 (14.7%) of patients, and that cannulation was achieved
Older age and diabetes mellitus identified as risk factors for poor patency rates following vascular access construction Different risk factors affect patency between vascular access construction and the first percutaneous transluminal angioplasty, Mahoko Yoshida (Hiroshima University Hospital, Hiroshima, Japan) and colleagues conclude in the Journal of Vascular Access (JVA). Their results indicate that a poor patency rate is commonly associated with advanced age, and diabetes mellitus. “THESE FINDINGS SUGGEST that older patients and those with diabetes mellitus are more likely to experience vascular access problems after both vascular access construction and percutaneous transluminal angioplasty [PTA], and that different risk factors should be taken into account when managing patients undergoing haemodialysis after vascular access construction and PTA,” the study authors write. “Understanding the risk factors that contribute to vascular access problems may lead to better surveillance and focused care in high-risk patients,
resulting in more effective management of vascular access.”
Dialysis: “A global health concern”
The number of patients undergoing dialysis worldwide has been increasing each year, the study authors write, and is considered a global health concern. The majority of dialysis patients receive haemodialysis, and are known to suffer from various complications, including cardiovascular disease and infections. The most frequent issue relates to problems with vascular access: stenosis,
in 67.3% of remaining fistulae within three months, rising to 87.3% by six months. In terms of primary patency, Crane and colleagues note that this was 76% and 69% at six and 12 months, respectively. Secondary patency at the same time points was 91% and 94%, respectively. Finally, the authors detail that dialysis access steal syndrome was clinically apparent in three (4.4%) patients, with all cases being managed conservatively. The authors recognise that steal syndrome is multifactorial in origin and not purely related to anastomosis calibre. In addition, “follow-up among the patients included in the study is limited,” Crane and colleagues write, adding that late presentations of DASS due to ongoing arterial and venous remodelling and subsequent increase in fistula flow may subsequently occur. A randomised trial with clear documentation of venous and arterial diameter along with postoperative duplex ultrasound and haemodialysis access flow assessment would be useful, they suggest.
A randomised trial with clear documentation of venous and arterial diameter along with postoperative duplex ultrasound and haemodialysis access flow assessment would be useful.”
thrombosis, aneurysm, and infection. “In fact,” Yoshida et al say, “the medical expenses for vascular access-related complications is estimated at JPY 10,953,310,000/year”. The investigators therefore surmise that “recognition of risk factors for vascular access failure is needed not only to improve the quality of life of patients undergoing haemodialysis, but also to reduce medical expenditure”. They conducted a multicentre, prospective, observational study of 611 patients who had started haemodialysis between 1 April 2012 and 31 March 2018, and investigated the primary and secondary patency rates after construction of a radiocephalic arteriovenous fistula (AVF) and arteriovenous graft (AVG). Primary patency was defined as the period from vascular access construction to percutaneous transluminal angioplasty or surgical revision within 24 months; secondary patency was defined as the period from vascular access construction to the date of vascular access abandonment. The study also examined the patency rate following percutaneous transluminal angioplasty (PTA)—defined as the period from the first PTA to the next PTA or surgical revision within 12 months—as well as the clinical factors that contributed
to the development of restenosis. All patients were followed-up until December 2018.
Post-PTA patency unaffected by vascular access form in older patients
The study results reveal that radiocephalic AVF exhibited better 24-month primary and secondary patency rates than AVG in patients who started haemodialysis: 54.5% and 91.6% versus 25.1% and 70.3%. The authors note that these 24-month primary and
The majority of dialysis patients receive haemodialysis, and are known to suffer from various complications, including cardiovascular disease and infections.” Continued on page 10
November 2020 | Issue 88
Older age and diabetes mellitus identified as risk factors for poor patency rates following vascular access construction Continued from page 8
secondary patency rates after vascular access construction are higher than those reported in the literature by researchers investigating patients outside of Japan. They postulate that the higher patency rates seen in Japanese patients could be due to the fact that they undergo haemodialysis with lower blood flow, which they suggest may enable the vascular access to be used for longer periods. While the patency rates after vascular access construction between the two vascular access forms (radiocephalic AVF and AVG) was not significantly different in the multivariate analysis, they did show a significant difference in the log-rank test. “With respect to the post-PTA patency rate, although radiocephalic AVF appeared to result in a better patency rate than that of AVG, the difference was not statistically significant in either the log-rank test or Cox proportional hazard model,” Yoshida and colleagues discuss. “A previous study reported that AVF exhibited a better patency rate after both vascular access construction and PTA than AVG. Notably, another study showed that the patency rate of AVF did not differ from that of AVG in advanced-age patients undergoing haemodialysis, especially those aged
>65 years. In the present study, the median age of the patients was 70 years, suggesting that rather than the vascular access form, the background of the patients may be more strongly associated with the patency rate.”
Risk factors for vascular access complications
A Cox proportional hazard model demonstrated that aging, female sex, diabetes mellitus, low serum albumin, and use of an erythropoietin-stimulating agent were associated with poor primary patency after vascular access construction in this study. Of these identified risk factors, aging, diabetes mellitus, and low serum albumin may be indicative of a patient’s poor general condition, the study authors muse, while female sex has reportedly been associated with smaller vascular diameter, which can increase the number of vascular access problems. “Taken together these results indicate that vascular access patency might be improved if modifiable risk factors identified in the present study are well controlled,” Yoshida et al write. Furthermore, aging, diabetes mellitus, polycystic kidney disease, initiation of haemodialysis with the use of a temporary catheter, and a
shorter period from vascular access construction to use were associated with poor patency after the first PTA. These results led the study investigators to conclude that patients need to start haemodialysis “urgently”. “These findings suggest that with the exception of ageing and diabetes mellitus, different risk factors contribute to the incidence of vascular access problems after surgical construction of vascular access and restenosis after PTA,” the authors conclude. “Our data showed that stenosis accounted for 92% of vascular access problems. […] These findings suggest that the presence or absence of
Understanding the risk factors that contribute to vascular access problems may lead to better surveillance and focused care in high-risk patients.” procedure-induced stimulation may cause differences in the risk factors that influence the patency rates after vascular access construction and that after PTA.” identified as risk factors for poor patency rates following vascular access construction Different risk factors affect patency between vascular access construction and the first percutaneous transluminal
Ellipsys system offers greater patient eligibility and reduced time to dialysis, study finds Two devices for creating minimally invasive dialysis access—the Ellipsys vascular access system (Avenu Medical) and the WavelinQ 4F system (BD)—demonstrated high rates of technical success and low rates of complications in a new study. IN ADDITION, BOTH TECHNOLOGIES enabled patients to start dialysis sooner compared to surgery, offering significant quality-of-life benefits. The results were published in the Journal of Vascular and Interventional Radiology. For patients with end-stage renal disease (ESRD) who require haemodialysis, the preferred type of vascular access is an arteriovenous fistula (AVF)—a permanent connection between a vein and artery in the arm. Until recently, the only way to create an AVF was through a surgical procedure that subjects patients to discomfort, longer recovery times and delayed dialysis. Both the Ellipsys and WavelinQ devices offer a nonsurgical alternative by using a minimally invasive approach to create a percutaneous arteriovenous fistula (pAVF). The new single-centre study, led by
angioplasty, Mahoko Yoshida (Hiroshima University Hospital, Hiroshima, Japan) and colleagues conclude in JVA. Their results indicate that a poor patency rate is commonly associated with advanced age, diabetes mellitus, female sex, low serum albumin, and the use of an erythropoietin-stimulating agent. “These findings suggest that older patients and those with diabetes mellitus are more likely to experience vascular access problems after both vascular access construction and percutaneous transluminal angioplasty [PTA], and that different risk factors should be taken into account when managing
vascular surgeon Robert Shahverdyan (Vascular Access Center, Hamburg, Germany), compared the outcomes for 100 patients who underwent pAVF procedures (65 Ellipsys and 35 WavelinQ) from December 2017 to December 2019. The Ellipsys system had a technical success rate of 100%, and only 27.7% of patients required secondary interventions following fistula creation. The WavelinQ system demonstrated similar outcomes, with a technical success rate of 97% and 26.5% of patients requiring secondary interventions. Overall, 79.5% of Ellipsys patients and 58% of WavelinQ patients were able to successfully begin dialysis with their fistula. At 12 months, 82% of Ellipsys fistulas were still functional, compared to 60% of WavelinQ fistulas. “For every patient, my goal is to create the best
patients undergoing haemodialysis after vascular access construction and PTA,” the study authors write. “Understanding the risk factors that contribute to vascular access problems may lead to better surveillance and focused care in high-risk patients, resulting in more effective management of vascular access.”
possible dialysis access with the fewest possible interventions,” said Shahverdyan. “Our data show that with careful planning, both systems can safely and quickly create percutaneous fistulas with a high rate of success, though the Ellipsys system appears to create more durable access that is also easier to repair if that becomes necessary.” Compared to surgical fistulas, both devices reduced the time to dialysis (cannulation). The mean time to cannulation for WavelinQ was 90 days, compared to 60 days with Ellipsys. In fact, 75% of Ellipsys fistulas were ready for cannulation at just four weeks, with a small number of patients ready for early cannulation within a few days of fistula creation, Shahverdyan notes. “This study confirms other newly published data showing how much faster we can start using the Ellipsys percutaneous fistula for dialysis—a finding that has significant patient safety benefits,” said interventional radiologist Jeffrey Hull (Richmond Vascular Center, Richmond, USA). “The sooner a patient can start dialysis with their fistula, the sooner we can get them off such riskier dialysis access methods as central venous catheters, which are associated with much higher rates of infection and other complications.”
Issue 88 | November 2020
Medtronic to acquire Avenu Medical Medtronic recently announced the planned acquisition of Avenu Medical, a medical device company focused on the endovascular creation of arteriovenous fistulas (AVFs) for patients with end-stage renal disease (ESRD) undergoing dialysis. Terms of the transaction were not disclosed. A PRESS RELEASE EXPLAINS THAT AVENU Medical’s Ellipsys vascular access system is a single-catheter, ultrasound-guided device that inserts a catheter percutaneously into the arm to create a durable AVF. The procedure can be performed in the hospital outpatient centre, ambulatory surgery center (ASC), or physician’s office. “AVFs are like lifelines to patients undergoing dialysis. Until recently, the only option to create a fistula was through invasive surgery, which is associated with high failure rates,” said Jeffrey Hull (Richmond Vascular Center, Richmond, USA), cofounder of Avenu Medical. “The Ellipsys system has shown durable outcomes out to two years and has the ability to shorten procedure times and potentially
reduce costs. Unlike open surgery, sutures are not required after the procedure and the patient leaves with just an adhesive bandage.” The Ellipsys vascular access system bears the CE mark for distribution in the European Union and is cleared by the US Food and Drug Administration. It is indicated in both geographies for the creation of a proximal radial artery to perforating vein anastomosis for percutaneous creation of an AVF. “Medtronic’s acquisition of Avenu aligns directly with our vision of bringing less invasive,
of Medicine,” said Mark Pacyna, vice president and general manager of the Peripheral Vascular business at Medtronic. “Now with the acquisition of Avenu Medical, we can support procedures across the vascular access care continuum, while continuing to provide innovative endovascular therapies that will ultimately reach even more patients with ESRD around the world.” The acquisition is expacted to close in October, subject to the satisfaction of certain customary closing conditions. The acquisition of Avenu Medical is the sixth in a series of tuck in acquisitions that Medtronic has made in 2020. The transaction is expected to be immaterial to Medtronic's adjusted earnings per share in the first two years before turning accretive in fiscal year 2023. In addition, this transaction is expected to meet Medtronic's long-term financial metrics for acquisitions.
endovascular solutions to patients requiring durable vascular access,” said Mark Ritchart, president and chief executive officer of Avenu Medical. “With Medtronic’s extensive market presence, clinical leadership, and market development expertise, coupled with Avenu’s customer-focused team and innovative technology, we are confident that together, we can drive awareness and adoption of this technology globally.” “Within the last year, we have seen significant momentum with the launch of the IN.PACT AV drug-coated balloon (DCB) in the USA and primary endpoint results of the IN.PACT AV Access study being published in The New England Journal
AVFs are like lifelines to patients undergoing dialysis. Until recently, the only option to create a fistula was through invasive surgery, which is associated with high failure rates.”
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November 2020 | Issue 88
12 CIRSE 2020
PERIPHERAL
New prediction model for target lesion revascularisation grants “new level of security” to paclitaxel devices in the peripheral arteries “Please feel free to utilise this in your practice,” Michael Dake (University of Arizona Health Sciences, Tucson, USA) urged on the first day of the Cardiovascular and Interventional Radiological Society of Europe 2020 Symposium (CIRSE; 12–15 September, virtual). Speaking during a FIRST@CIRSE session, he presented a new, interactive, web-based tool built to predict patients’ freedom from target lesion revascularisation (TLR) following treatment with the Zilver PTX (Cook Medical) drugeluting stent (DES).
D
ake and colleagues used patient and lesion factors from five global clinical studies from Cook Medical to develop a prediction model for freedom from target lesion revascularisation (TLR) following use of Zilver PTX. These clinical studies studied both pre-market and post-market outcomes with the Zilver PTX stent in patients with femoropopliteal disease. In total, the collated data came from 2,374 patients, and included 15 risk factors in their creation of the model. “It is noteworthy that over 50% of the patients included in the model had over five-year follow-up. In fact, this is the first prediction model to estimate the impact of patient and lesion characteristics on freedom from TLR through five years for patients with PAD,” Dake enthused. “Based on unique patient profiles, the model provides expected patient outcomes following treatment with the Zilver PTX DES, and may assist in defining algorithms for patients as the value of population management is increasingly recognised.” Turning to the freedom from TLR results, Dake informed the CIRSE audience that 94% of the complete dataset (2,227 cases, with a median follow-up time of two years) was used to generate the model. Freedom from TLR was 90.5% at one-year, and 75.2%
at five years. Describing the model more closely, Dake next related the 15 risk factors that were considered when the tool was under construction: sex, age, diabetes, hypertension, hypercholesterolemia, renal disease, smoking status, Rutherford classification, lesion length, dexamethasone, popliteal involvement, total occlusion, calcification, prior interventions, and the number of patient runoff vessels. “Most all of these have been in the past implicated as being high-risk for TLR in studies performed over the last two decades,” Dake disclosed. He continued: “Risk factors common in PAD patients collectively contributed to overall prognosis. As expected, chronic limb-threatening ischaemia (CLTI), lesion length, and total occlusion have a significant impact on TLR. Other factors, such as diabetes and calcification, do not have a significant impact on TLR.” He then talked through three example patient profiles to illustrate how listening physicians could use this predictive model in their own practices. The risk factors any given patient may have are fed into the model, which then churns out an estimation of the risk that patient has of maintaining freedom from TLR out to five years, with a standard error given, when treated with the Zilver PTX. These
Over
50%
of the patients included in the model had over five-year follow-up
Calls in Germany for reimbursement as analysis shows drug-eluting technology is cost-effective Stefan Müller-Hülsbeck (Ev Luth Diakonissenanstalt zu Flensburg, Flensburg, Germany) presented attendees of the online meeting of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE; 12–15 September, virtual) with an update from the IMPERIAL head-to-head randomised trial comparing the Eluvia drug-eluting stent (DES; Boston Scientific) with the Zilver PTX DES (Cook Medical) for the treatment of femoropopliteal artery lesions. “THROUGH 24 MONTHS, THERE was a significantly lower clinicallydriven target lesion revascularisation (CD-TLR) rate for the Eluvia DES than for the Zilver PTX [12.7% vs. 20.1%; p=0.0495],” Müller-Hülsbeck told registrants. An “excellent” primary patency rate was sustained with the Eluvia DES (83% from Kaplan-Meier estimates), and both study devices
showed a low mortality rate at 24 months: 7.1% for Eluvia, and 8.3% for Zilver PTX. Cost-effectiveness analysis of the US Medicare system and the German health insurance system showed cost savings; on average, US$1,300 per patient was saved when patients were treated with the Eluvia device in the USA, MüllerHülsbeck said.
results also translate into a freedom from TLR KaplanMeier curve. The physician can then make an informed treatment decision based on individual risk factors.
The baseline data
Teasing apart the larger dataset to examine trends in baseline patient demographics, Dake said: “Looking a bit closer at some of these individual patient demographics, and how they are distributed within the various trials included in the analysis, you can see some differences. Of note, in the Japan post-market study, [there is] a very high frequency of renal disease, and a higher frequency of CLTI. In terms of diabetes, there was a high frequency in all studies, approaching 50%.” Appraising the baseline lesion characteristics, Dake informed viewers that 42% of patients had total occlusions, and that there was an increased number of prior interventions in both the single-arm study and the Japan post-market study, as both these trials included in-stent restenosis. “Patients with in-stent restenosis were not allowed to enter the other trials,” he explained.
“This is the first step”
Praising Dake for these results, moderator Stefan Müller-Hülsbeck (Diako Hospital, Flensburg, Germany) commented: “I think you have shown once again that paclitaxel is probably safe, and we meet a new level of security when using these kinds of devices, especially when using this kind of predictability model.” He then asked Dake if the model is already in use, and if so, if he was using it for his patients during his daily practice. “This is actually the first debut of this model and this website,” Dake responded. “The manuscript will be published in Cardiovascular and Interventional Radiology (CVIR).” He encouraged CIRSE attendees to visit the site themselves and “really get a sense of getting comfortable with how individual risk factors can affect TLR going out through five years”. Referring to his presentation as the launch of this predictive model, Dake closed the discussion by postulating: “Maybe other device manufacturers will look at this as a model and adopt predictive models as a way to counsel patients and their families in the clinic regarding their individual risk factors, modification of those risk factors, how we can really just predict and have them anticipate what results might be with individual different devices. I think this is the first step.”
Moderator Fabrizio Fanelli (Careggi thought this could “push the use of University Hospital, Florence, Italy) Eluvia, or more generally drug-eluting stated: “There is a pretty important gap stents” in the future. between the Eluvia DES and the Zilver “I think yes,” Müller-Hülsbeck PTX”. He queried if Müller-Hülsbeck replied, “especially in the USA, because thought this gap would grow larger there are some major differences. in the future, or if he believed that In Germany, I do not know exactly, outcomes from using these two devices because the difference there is slightly would become more similar in time. lower, but it is my hope—as we want Müller-Hülsbeck responded: to avoid patients coming back for early “Probably the results from [using] target lesion revascularisation—that both stents could differ, but I think this kind of technology becomes more there is also a high probability that the accepted by insurance companies for curves in terms reimbursement. of target lesion I am mentioning revascularisation that because, at the might come closer, moment, especially so we have to see in Germany, we what will happen do not receive any in five years. reimbursement if Turning tack to we use drug-eluting discuss the costtechnology, either effective analysis, the Zilver PTX or Fanelli next asked the Eluvia stent.” Stefan Müller-Hülsbeck and if Müller-Hülsbeck Fabrizio Fanelli
November 2020 | Issue 88
14 Paclitaxel
PERIPHERAL
Vascular surgeons encouraged to consult talking points document on paclitaxel devices Vascular surgeons are being encouraged to take consideration of a set of talking points about the risks and benefits of paclitaxel-equipped devices—which has been developed by a multispecialty panel of medical societies—in discussions with their patients. THE DOCUMENT, PUBLISHED ON 11 September 2020, is the work of the Multi-Specialty and Multi-Society Coalition for Patient Safety With Paclitaxel Technologies, which includes three leading vascular surgical membership bodies: the Society for Vascular Surgery (SVS), the Vascular and Endovascular Surgery Society (VESS), and the Society for Clinical Vascular Surgery (SCVS). The US Food and Drug Administration (FDA) tasked the coalition with putting together bullet points that reflect the current evidence around paclitaxel devices. The American College of Cardiology, American College of Radiology, American Heart Association, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine, and the Society of Interventional Radiology make up the remainder of the membership bodies on the coalition. “The coalition bullet points reflect the current evidence surrounding this complex topic and is
designed to help institutions and members to use when discussing PAD treatment options with their patients: discussing increased rate of long-term mortality in Some balloons and stents used to treat symptoms patients treated with paclitaxel-coated balloons and resulting from blocked blood vessels in leg(s) are paclitaxel-eluting stents,” the coalition stated. coated with the drug paclitaxel. “The statements are intended to summarise the Research studies show that paclitaxel-coated current state of the evidence and to serve as starting balloons and stents improve the chance that the treated points for discussion. blood vessel in your leg will remain open after your “The ability to effectively communicate risk treatment and lower the likelihood that you will and benefit of revascularisation is key part need a repeat procedure to re-open the of procedure selection. Please consider vessel. the following statement in your However, an analysis in discussions and informed 2019 that combined the consent process.” The results from multiple document follows in full. studies indicated that the A recent meta-analysis of use of paclitaxel-coated randomised trials suggests balloons and stents may an increased mortality increase your chance of rate after two years in dying, starting about two peripheral artery disease years after treatment. (PAD) patients treated with Although this analysis paclitaxel-coated balloons has limitations and further and paclitaxel-eluting stents research is still ongoing, for femoropopliteal disease the available information compared to patients treated as of April 2020 suggests with uncoated balloons or bare that paclitaxel-coated device use metal stents. The FDA recommends that may increase your chance of dying physicians discuss the risks and benefits of over the next two-to-five years compared to all available treatment options with treatment with uncoated balloons Paclitaxel their PAD patients. or bare metal stents. To this end, a Multi-Specialty There may be other options Paclitaxel Coalition (American College of Cardiology, for the treatment of your symptoms, including American College of Radiology, American Heart medications, exercise, balloons, stents or other devices Association, Society for Cardiovascular Angiography that do not contain paclitaxel, and surgery. You and and Interventions, Society for Vascular Medicine, your doctor should discuss the possible risks and Society of Interventional Radiology, Society for benefits of all treatments to identify those options that Vascular Surgery, Vascular and Endovascular Surgery are best for you. Society, and the Society for Clinical Vascular Surgery), The Multi-Specialty Paclitaxel Coalition is actively representing the majority of specialists who evaluate working with the FDA, medical device manufacturers, and treat patients with PAD, developed the following and clinical investigators to advance our understanding talking points, which have been reviewed by the of the long-term safety and effectiveness of paclitaxelFDA, that physicians/providers may consider when coated devices.
CDC recognises and codifies critical limb-threatening ischaemia in ICD-10-CM A coalition organised by the CLI Global Society (CLIGS) has announced its proposal to distinctly recognise “critical limb ischaemia” (CLI) and “chronic limb-threatening ischaemia” (CLTI) in the International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) was approved by the Centers for Disease Control (CDC) and went into effect on 1 October 2020.
T
he ICD-10-CM is a worldwide standard reference set of disease codes used to report medical services provided to patients. The announcement marks a major step forward in tracking patient treatments and outcomes for CLI and CLTI, which affect millions of patients globally. The CLIGS worked in close partnership with the vascular specialist community to develop the proposal. Coalition members include: Robert Lookstein, CLIGS Barry T Katzen, CLIGS Sean Roddy, Society for Vascular Surgery (SVS) Mitchell Weinberg, Society for Vascular Medicine (SVM) Bulent Arslan, Society of Interventional Radiology (SIR)
Mehdi Shishehbohr, Society for Cardiac Angiography and Intervention (SCAI) The goal of this initiative is to support coding professionals, educators, compliance staff, and physicians to identify and accurately report CLI and CLTI in clinical documentation, electronic medical records, and medical billing in order to track and monitor patient treatments and outcomes in the future. “This effort is a first step in building awareness of the complexity associated with caring for patients who suffer from CLI within public and commercial payers and the broader healthcare community,” says Barry Katzen, board chair of the CLIGSS. “These dedicated codes, now newly identified for CLI, are critical in our goal
to improve quality of life by preventing amputations and death due to CLI.” Lookstein, chair of the Vascular Societies Workgroup and CLIGS board member, acknowledges the collective effort of his colleagues, “who came together to prioritise the need for a well-defined and accessible method to identify, report, and track CLI for the benefit of patients who suffer from this disease. “We also look forward
This seemingly small change to medical coding will allow us to save countless limbs— and lives.”
to continued partnership as we launch initiatives to educate our membership, our hospitals, and healthcare-provider staff regarding these changes,” Lookstein explains. “They have the potential to positively impact the care we provide to these extremely vulnerable patients across the USA and around the world.” CLI and CLTI are advanced forms of peripheral arterial disease (PAD), a common circulation problem that occurs when arteries that carry blood throughout the body become narrowed or blocked, restricting blood flow to legs and feet. Those who smoke, have diabetes or chronic kidney disease, or suffer from high blood pressure or high cholesterol are susceptible to CLI and its complications. Left untreated, CLI can lead to tissue loss, gangrene, amputations, and eventually death. “The statistics are grim,” says Jihad Mustapha, founding board member of the CLIGS. “We know 60% of patients who receive an amputation due to PAD or CLI die within two years—this is higher than the five-year mortality rate for patients with breast, colon, and prostate cancer. “In order to fight this deadly disease, we need to have accurate data. This seemingly small change to medical coding will allow us to save countless limbs—and lives.”
November 2020 | Issue 88
16 CIRSE 2020
PERIPHERAL
Patients with multiple revascularisations are at higher risk of acute limb ischaemia, and derive “particularly robust benefit” from rivaroxaban Symptomatic peripheral arterial disease (PAD) patients undergoing recurrent lower extremity revascularisation have higher rates of ischaemic events, particularly acute limb ischaemia, than those patients who are undergoing their first peripheral revascularisation. This is the conclusion presented by Marc Bonaca (University of Colorado, Aurora, USA) at the 2020 meeting of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE; 12–15 September, virtual). Bonaca and colleagues conducted a subgroup analysis from the VOYAGER PAD trial. VOYAGER PAD IS A TRIAL OF 6,564 patients with symptomatic lower extremity PAD undergoing peripheral revascularisation. Patients were randomised 1:1 in a double blind fashion to either the rivaroxaban group, where they received 2.5mg of the drug twice daily, or a placebo group. The primary efficacy endpoint was a five-point composite of acute limb ischaemia, major amputation of vascular aetiology, myocardial infarction, ischaemic stroke, or cardiovascular death. The primary safety endpoint was thrombolysis in myocardial infarction (TIMI) major bleeding. In an assessment of the primary efficacy endpoint, the rivaroxaban group performed better than the placebo group, with fewer incidences of the five major complications included in the composite measurement. “In spite of best medical therapy in this population [those patients treated with a placebo], the event rate was nearly 20%, which was extremely high—nearly one in five had an event,” Bonaca said. A Kaplan-Meier curve plotting cumulative incidence of the composite measurement of major adverse events against time since randomisation revealed that, at three-years post-treatment initiation, the event rate was 19.9% in the placebo group, and 17.3% in the rivaroxaban arm (hazard ratio [HR], 0.85; 95% confidence interval [CI], 0.76–0.96; p=0.009). “Rivaroxaban risk-benefit was apparent early, and continued over time,” Bonaca commented, “with an
those undergoing their first revascularisation. They hypothesised that repeat revascularisation patients would have a higher rate of acute limb ischaemia, and would derive “even greater benefits with a rivaroxaban plus aspirin strategy versus aspirin alone”. The presence of known prior revascularisation was reported by investigators at baseline, and was
Stefan Müller-Hülsbeck and Marc Bonaca
defined as any history of endovascular, hybrid, or surgical lower extremity revascularisation. The primary outcome was the same composite as in the VOYAGER PAD study, and a COX model with interaction terms was used to assess for heterogeneity of efficacy and safety of rivaroxaban by prior lower
Figure 1; LER is lower extremity revascularisation
absolute risk reduction of 2.6% at three years, and a number needed to treat of just 39.” Bonaca and colleagues conducted a subanalysis investigating symptomatic PAD patients undergoing recurrent lower extremity revascularisation versus
extremity revascularisation status. From a comorbidity perspective, the prior revascularisation group had a higher risk profile, Bonaca shared, with more hypertension, diabetes, and hyperlipidaemia. PAD characteristics were similar between the two cohorts,
with the prior revascularisation group having a slightly lower risk: “they were more likely to be treated with an endovascular revascularisation, they had less frequently presented with acute limb ischaemia versus claudication, and the [average] ankle-brachial index was a bit higher. […] It is worth noting that they were very well-treated.” In the placebo cohort, the cumulative event rate for those with no prior lower extremity revascularisation was 17.7%—“very high,” Bonaca pointed out, “even in this very well-treated population.” Nevertheless, those patients who had had a prior revascularisation had a higher cumulative event rate of 23.8%, representing a 6.1% increase in risk. “When we look at the efficacy of rivaroxaban, stratified in these two groups [prior revascularisation and no prior revascularisation], we see the benefit is there for both groups,” Bonaca explained. In the rivaroxaban cohort, those with no prior revascularisation had a cumulative event rate of 16.9%, while those who had undergone an earlier revascularisation had a cumulative event rate of 18.1%. The impact of prior revascularisation was therefore less in the rivaroxaban cohort than in the placebo cohort. Comparing the placebo and rivaroxaban cohorts (Figure 1), Bonaca told delegates: “The benefit [of rivaroxaban] appears even greater in those who had a
These observations further demonstrate the heterogeneity of risk in the PAD population, and may assist in clinical risk stratification and therapeutic decision-making.” prior history of revascularisation, with a HR of 0.73, and a trend towards heterogeneity, meaning there may be an even greater benefit in this high-risk group.” Bonaca and colleagues looked at the limb outcomes of acute limb ischaemia and vascular amputation in patients treated with rivaroxaban with and without prior lower extremity revascularisation. In placebo patients with no prior revascularisation, rates of acute limb ischaemia and vascular amputation were lower at threeyears post-randomisation than they were in the group of patients who had had previous revascularisation: 6% vs. 10.8%, and 3.4% vs. 4.5%, respectively. As Bonaca put it: “Patients in the prior revascularisation group have a very high risk of acute limb ischaemia, almost 11%, and that is driving this risk-profile, and that benefit for acute limb ischaemia [with Rivaroxaban] is even greater in patients with a prior history of revascularisation. This does look like our hypothesis—that repeat revascularisation patients are at higher risk and would derive a greater benefit of rivaroxaban—was met in this analysis. “Rivaroxaban plus aspirin versus aspirin alone reduces irreversible harm events, so the heart, limb, and brain in patients that are undergoing revascularisation, but in this subgroup with prior revascularisation, there is a particularly robust benefit, and really notably in acute limb ischaemia. The current analysis demonstrates that within this population, those with multiple revascularisations are at higher risk than those who have undergone a first revascularisation only, and may derive particularly robust benefit from rivaroxaban plus aspirin versus aspirin alone. These observations further demonstrate the heterogeneity of risk in the PAD population, and may assist in clinical risk stratification and therapeutic decision-making.”
November 2020 | Issue 88
20 Interview
Profile
Chris Imray
President of the Vascular Society for Great Britain and Ireland (VSGBI) 2019–2020 and avid climber Chris Imray discusses various aspects of his career. He considers how the field has changed, outlines his continued research into how the brain responds to hypoxia and ischaemia, and highlights a "particularly important" study into COVID-19 and vascular surgery.
What led you to pursue a career in vascular surgery?
I trained at Charing Cross Hospital (London, UK) in the early 80s and within the first year or so, I was certain that I wanted a career in general surgery. The particular sub-speciality at the time did not seem that important. I am sure I was influenced by a number of surgeons but Keith Reynolds, an upper gastrointestinal tract surgeon stands out in my memory.
Who have been your mentors and what lessons did you learn from them?
Professor Roger Greenhalgh and Janet Powell at Charing Cross run a huge academic vascular practice and over the years have provided much crucial evidence on how aneurysms are best treated. Having good evidence to support complex interventions is a key component to safe modern surgery. Other standout professional mentors include Professor Richard Downing in Worcester, UK, whose technical prowess and quiet confidence impressed me enormously. Malcolm Simms, with his local anaesthetic distal vascular reconstructions stood out, as did Simon Smith, who taught me a lot of the principles on how to look after carotid surgical patients. Finally, Ross Naylor’s research has lead the transformation in safety of modern carotid surgery. In the altitude world, Tom Hornbein (US anaesthetist and first to traverse Everest in May 1963), the late Many Cauchy (Chamonix physician and guide), Jim Milledge (respiratory physician) and Jo Bradwell (Birmingham immunologist) have both inspired me and influenced many of the decisions I made.
How have you seen the vascular field develop over the course of your career?
In the early 80s vascular surgery was very much an open speciality, where ‘heroic’ procedures were undertaken by heroic surgeons. At that time in my career, that seemed like a very exciting prospect and it was probably one of the reasons I was drawn into it. Gradually, we moved away from the individual hero to team-based approaches. The vascular surgeon is very much the conductor of the complex and interrelated orchestra. The introduction of minimally invasive endovascular approaches has dramatically changed the options that are open to the patient and medications have evolved considerably with the growth of statins and dual antiplatelets. Finally, and an area of particular interest to me, links aspects of high altitude physiology and understanding the cardiorespiratory factors. Trying to match up the magnitude of the surgery/intervention with the fitness of the individual patient has become key.
How do you anticipate the field might change in the next decade and what developments would you like to see?
I think the patient voice is finally being recognised as a key component in the decision-making, this is probably somewhat overdue. Integration of open, endovascular, medical treatments are becoming more important. Just as we have seen in many of the elite sporting teams, maintaining a high level of attention to small details is delivering the best results. I think we have also moved away from an individual-based service to a much more
team-based approach. While I think developments on how to make the most of a team are probably going to be crucial in the future, I think understanding fitness of the individual and fine-tuning the best choice between an open, hybrid, or endovascular approach will become increasingly important. I think this will begin to help us as we improve on data collection, giving us a better idea as to which is the most appropriate personalised intervention.
In the last year, which new research paper has caught your attention?
The recently published COVER study, led by the trainee Vascular and Endovascular Research Network looking at the impact of COVID-19 on vascular surgery will turn out to be a particularly important study. I think we are likely to look back even in 10 or 15 years’ time and reflect upon the secondary impact that COVID-19 has had on our lives and particularly our high-risk vascular patients.
What are your current areas of research?
One of the features of my career to date is that although it has been somewhat unstructured, my enthusiasm and energy to explore new concepts and ideas has remained undiminished. Currently, I am particularly interested in fitness for surgery, multidisciplinary team working and my continued area of research is how the brain responds to hypoxia and ischaemia. I was very excited that, just prior to COVID-19, we managed to get 12 patients through a phase one pharmaceutical interventional study giving dexamethasone to try and prevent simulated high altitude cerebral oedema. Unfortunately, with COVID-19 this has all been put on hold, but I am hoping we will be able to get this up and
I think the patient voice is finally being recognised as a key component in the decision-making process.” running again shortly. We have previously shown that 24 hours of 12% oxygen can simulate MRI measurable cerebral oedema and the question here is whether or not intravenous dexamethasone can mitigate this, and by what mechanism.
How has your work in vascular surgery influenced your altitude research and vice versa?
I have been described as a translational physiologist using hypoxia and the perturbations that we can generate at altitude as a potential model for the ischaemia we see at altitude. My PhD is on hypoxic and ischaemic brain and much of my work has been around these subjects. I am a strong proponent of cardiopulmonary exercise testing and this came out of research on Everest, undertaking VO2 max tests on the South Col (8,000m). In 2007, we had an unacceptably high mortality rate from open aortic surgery in my practice in the UK
and I recall a fascinating discussion with the then chief medical officer, arguing the case that we should introduce cardiopulmonary exercise testing into our unit in order to risk-stratify the patients undergoing open surgery. His answer was that it was too complex an undertaking in a hospital, but I was able to respond with the fact that we had done this at 8,000m and the case was won. Subsequently, we have dramatically improved our results using this risk stratification method (along with many other units).
What advice would you give to someone starting their career in vascular surgery?
Firstly, I think this is one of the most exciting and varied specialties there is. I have been fortunate enough to travel all over the world using the research in both vascular surgery and extreme environments as the pretext to these excursions. I think it important that modern vascular surgery understands the different
Issue 88 | November 2020
Interview 21 modalities available and is skilled in practicing them. I certainly did not plan much of my career, so I think that another piece of advice is to take opportunities as they occur. Having a positive and enthusiastic approach to the opportunities stands you in great stead. I think that having a good work–life balance is also the key to sustaining the energy and enthusiasm. I see many people who at the end of their career are not as enthusiastic as they originally were and I have been fortunate that my travel and research interests have kept me as enthusiastic as when I started out.
What are the biggest challenges currently facing vascular surgery? I think COVID-19 will turn out to be probably the biggest and most impactful event in medicine for the next 10 or 15 years and it is difficult to see something more challenging than that, unless one considers climate change, which I believe is the biggest challenge currently facing humanity.
What have been the highlights of your of VSGBI presidency?
When Ian Loftus put the chain of office around my neck in Manchester in November 2019, my biggest worry was whether the provisional NICE guidelines on abdominal aortic aneurysm surgery would be accepted. The guidelines were finally released and, in my view, were a pragmatic solution to the difficult open/EVAR problem. Access to EVAR has turned out to ne a crucial adjunct in the COVD-19 crisis. Following that, the rest of my presidency has been focused on the COVID-19 crisis. I have been extremely fortunate to work with a superb council. At the heat of the crisis, we were having weekly meetings on Zoom discussing how, first of all, we shut down vascular surgery in order to allow people to prioritise more urgent and emergency work, and then subsequently, the challenge of trying to restart. The council has been supremely supportive, and one of the most amazing reflections I have looking back on that is how they have worked together towards a common purpose in a collaborative fashion.
How do you like to spend time outside work?
As a teenager I was obsessed with climbing. I took a year out of medical school to work in Nepal and to climb in the Himalayas. Throughout my medical and surgical career, I have continued to climb. I managed to climb the highest summit on each of the continents (Seven Summits), completing the last in 2019. The odyssey had started unintentionally on our honeymoon on Kilimanjaro in 1988. I was fortunate that my wife shared both my interest, and understood my passion for, the mountains and although she sadly died in December 2019, I cannot thank her enough for the support she gave me and our family.
Fact file Current positions (selected)
1995–present Consultant vascular, renal transplant, and trauma surgeon, University Hospitals Coventry & Warwickshire NHS Trust, Coventry, UK 2009–present Honorary professorships, Warwick Medical School and Coventry University, Coventry, and Exeter University, Exeter, UK 2019–2020 President, Vascular Society of Great Britain and Ireland
Qualifications
1983 MB BS, Charing Cross Hospital Medical School, London, UK 1988 FRCS, Charing Cross Hospital Medical School, London, UK 2004 Diploma in Mountain Medicine, University of Leicester, Leicester, UK 2005 PhD in cerebral perfusion 2007 Diploma in Clinical Medical Sciences 2009 Honorary fellow, Royal College of Physicians 2011 Fellow, Royal Geographical Society 2020 Fellow, Faculty of Sports and Exercise Medicine
Publications (selected)
Saratzis A, Benson RA, Wayte S, et al. Acute kidney injury in aortic intervention: Findings from the Midlands Aortic Renal Injury (MARI) cohort study. European Journal of Vascular and Endovascular Surgery 2019; S1078–f5884(19)32021-0. doi: 10.1016/j.ejvs.2019.09.508. Benson R, McGregor G, Shehata M, et al. Optimising fitness for major vascular surgery. British Medical Journal 2019; 366:15002. doi: 10.1136/bmj.l5002.
November 2020 | Issue 88
22 New research
PERIPHERAL
RCT finds communitybased cardiac rehabilitation benefits intermittent claudication patients A recent randomised controlled trial (RCT)—the CIPIC Rehab study—found that three-months’ community-based cardiac rehabilitation improves walking distance in patients with intermittent claudication. It was also found to improve physical activity level, diet, and health-related quality of life. These results were presented by Maj Siercke (University of Copenhagen, Copenhagen, Denmark) during ESVS Month (29 September–29 October), the digital replacement for this year’s European Society for Vascular Surgery (ESVS) annual meeting. “WE KNOW THAT SUPERVISED exercise training improves walking distance and health-related quality of life,” Siercke began, adding that typical programmes include treadmill-based exercise. Siercke then referenced a 2009 Journal of Vascular Surgery study by Kruidenier et al, however, suggesting that treadmill exercise does not work for claudicants, “maybe because it is very boring and hard work,” she speculated. In response to the need for
an alternative, the presenter relayed to the online audience that communitybased cardiac rehabilitation programmes are well-established in the Danish community and “could easily be adapted for patients with claudication”. In the present study, Siercke and colleagues randomised 118 patients 1:1 to either a control group or an intervention group. Patients in the control group were given a logbook to record steps, a patient information brochure, and medication, while
Systematic review and metaanalysis finds “substantial” oneyear mortality rate in octogenarians after revascularisation for CLTI In octogenarians with chronic limbthreatening ischaemia (CLTI), researchers found a one-year mortality rate of 32% after revascularisation, which was significantly higher than in nonoctogenarians. Amputation rates were comparable between both age groups.
T
he authors—Lina F Wübbeke (Maastricht University Medical Centre, Maastricht, The Netherlands), Barend ME Mees (Maastricht University Medical Centre, European Vascular Centre, Aachen-Maastricht, Germany, and European Vascular Centre, Maastricht, the Netherlands) and colleagues— comment that this mortality rate is “substantial”. Writing in the European Journal of Vascular and Endovascular Surgery (EJVES), they remark: “This [outcome] is of major importance to clinical practice to inform patients and colleagues adequately during the decision-making process of any intervention in this
Community-based rehabilitation improved maximum walking distance by
37%
at six months those randomised to the intervention group were given a more extensive rehabilitation programme. Siercke outlined that the content of the intervention group programme consisted of two weekly exercise sessions for 12
fragile patient group.” The authors do acknowledge, however, that only low-quality evidence could be obtained supporting the results of this meta-analysis, because only observational studies were available for inclusion. Discussing their methods, Wübbeke, Mees, and colleagues detail that two independent researchers searched systematically Medline, Embase, and Cochrane Library databases. Meta-analyses were performed to analyse one-year mortality, one-year major amputation, and one-year amputation-free survival (AFS) after revascularisation. Wübbeke, Mees et al write that the review includes 21 observational studies with patients who were treated for CLTI, and that a meta-analysis of 12 studies with a total of 17,118 patients was performed. Writing in EJVES, the authors report that a mortality rate of 32% was found in octogenarians (95% confidence interval [CI] 27–37%), which was almost double the mortality rate in the non-octogenarians (17%, 95% CI 11–22%/OR 2.52, 95% CI 1.93–3.29; GRADE: “low”). They also state that no significant difference in amputation rate was found (octogenarians 15%, 95% CI 11–18%; non-octogenarians 12%, 95% CI 7–14%; GRADE: “very low”), and that amputationfree survival (AFS) was significantly lower in the octogenarian group (odds ratio [OR] 1.55, 95% CI 1.03–2.43; GRADE: “very low”). In a subgroup analysis differentiating between endovascular and surgical revascularisation, amputation rates were comparable, Wübbeke and colleagues detail. For octogenarians, those treated conservatively had a mortality rate significantly higher than those treated by revascularisation (OR 1.76, 95% CI 1.19–2.6; GRADE: “very low”). No significant difference in mortality
weeks, involved active engagement with groups of up to 10 patients, and included varied forms of physical exercise. Siercke reported that while maximal walking distance—the primary outcome—increased in both the control and intervention groups, the increase was 37% greater in the intervention group after six months. In addition, maximal walking distance was sustained over 12 months. In terms of secondary outcomes, the investigators found no significant difference in pain-free walking distance after six and 12 months, but did find a significant increase in physical activity in the intervention group compared to the control group at six (52% vs. 32%) and 12 (52% vs. 25%) months. While Siercke et al found no significant differences in either smoking or alcohol consumption after six and 12 months, they report improvements in diet after six and 12 months. Finally, quality of life score improved significantly in the intervention group at both six and 12 months. However, the investigators did not find any differences in anxiety and depression scores at either six or 12 months. Siercke concluded that three-months’ community-based rehabilitation improved maximum walking distance by 37% at six months, compared to the usual care in patients with intermittent claudication. In addition, the same positive effect was found in physical activity level, health-related quality of life, and improvement in diet.
rate was found between primary amputation and revascularisation in octogenarians (OR 0.7, 95% CI 0.24–2.03; GRADE: “very low”). In the discussion of their findings, Wübbeke, Mees et al recognise that their study is limited by the weakness of the Lina F Wübbeke available evidence. “No randomised controlled trials were available for inclusion,” they write, adding that 19 of the 21 studies were retrospective cohort studies, “increasing the risk of information bias”. They add that the current Global Vascular Guidelines on the Management of CLTI also stressed that high-quality data on ‘evidence-based revascularisation’ is limited. Considering future research, Wübbeke, Mees et al recognise that additional studies are needed “to provide more solid results and to determine the optimal management of octogenarians with CLTI”. Moreover, they write that outcomes after revascularisation have to be compared with outcomes after conservative treatment or primary amputation and standardised study designs and endpoints should be used as promoted by the current Global Vascular Guidelines on the Management of CLTI. Finally, they state that these results should also be used to develop adequate risk scores, enabling appropriate patient selection, and that quality of life studies should be performed to decide whether revascularisation interventions are always indicated in this group of frail patients.
November 2020 | Issue 88
24 ESVS 2020
Aortic disease in women and men: Overcoming challenges for a promising future Rebecka Hultgren Comment & Analysis Based on the Janet Powell Honorary Lecture she gave at this year's European Society for Vascular Surgery annual meeting (ESVS Month; 29 September–29 October, virtual), Rebecka Hultgren details contemporary knowledge within the broad spectrum of aortic diseases, with specific emphasis on relevant sex differences.
O
ne can identify three areas that probably hold the largest gains in order to achieve a promising future for patients with aortic disease: first, to decrease aortic-disease related deaths in the population; secondly, to decrease aortic-disease related shortterm deaths in the treated diagnosed population; and finally, to improve the long-term survival in successfully treated patients. An important factor to consider in all the efforts to achieve improved survival in the population is that the majority of persons, that also have an earlier onset of disease, are male. The women with an aortic disease represent a minority with a considerably later onset of disease. The primary focus has in the last three decades been to screen risk groups in the population with a high prevalence of disease. This has been evaluated and proven in elderly men in the well-cited randomised controlled trials (RCTs) and confirmed in later years in several observational studies. The only other possible screening model that could be cost-effective, also including women, would be to screen first-degree relatives to abdominal aortic aneurysm (AAA) patients, but these models must be evaluated further. A more intriguing scientific challenge would be to further explore the triggers for development of disease in the population, in women and men, in order to minimise these risks. Ongoing translational work, animal models, and some clinical studies do support that sex hormones can be of great interest in this context. The immediate clinical value of such an understanding, of the possible causality between sex hormone levels and development of AAA presently is distant, but once this is explored or confirmed it will certainly influence our care trajectories of persons at risk. A problematic, important, and commonly ignored fact within this area is that the vast majority of patients with aortic disease never are treated, and
this large proportion are not included
and dissection. To better understand the treated patients, and the dominating sex-differences in eligibility for treatment and worse outcome, this must be increasingly included in our scientific work. The histograms illustrate the Swedish experience with AAA patients and patients with dissection, visualised by showing the proportion of treated versus untreated patients with diagnosis. Women are repeatedly reported to be overrepresented in non-eligibility groups, untreated at rupture or in intact AAA cohorts, with few in-depth explorations to investigate such sex-or gender differences. To move the understanding of eligibility and treatment outcome forward in clinical care, one must include new perspectives on how we survey patients and what the thresholds for repair actually are based on. The concept of aortic size index (ASI), rather than just diameter will certainly be included in the future models of surveillance strategies. Other methods that could certify that patients are treated “just-in-time” are possible complimentary biomechanical methods. It is sad to note that we still, even if the knowledge of ASI and biomechanic methodology has been out
Histogram of all patients diagnosed with AAA. Summary by Hultgren, Data from the NBHW, Sweden.
Histogram of the distribution of patients diagnosed with dissection. Summary by Hultgren, Data from the NBHW, Sweden.
in scientific work. The worse survival rate in treated groups of women with AAA has been shown repeatedly in many papers, for open, endovascular, intact or ruptured, or for complex aortic repair. This is unfortunately also now reported for other aortic disease groups, such as thoracic aortic aneurysm (TAA)
there for quite some years, still do not have the means to include it in daily clinical practice. Possibly RCTs are the only way to move in order to include it in future recommendations. Last, the poor long-term relative survival in treated AAA patients was reported quite some years ago from us
and others. This was recently confirmed again in a new collaborative project with The Netherlands, a manifest 20% lower relative survival at four years for treated women, even when compared to a population with similar risk factors. This is an area where we would have expected improvement over time, with improved secondary prevention strategies, but unfortunately, no real positive trend is found for men or women. The future could be promising for all patients within the whole spectrum of aortic diseases, but care-givers in vascular surgery must improve their understanding of clinically relevant sex or gender differences by combining knowledge from guidelines, clinical and translational papers, and exploring their national-regional outcomes with these perspectives in order to achieve this goal. A more robust clinical implementation of our broad scientific knowledge will change the future for our aortic patients, both women and men. Selected references from the lecture 1. Bulder, R, Talvitie M, Hultgren R, et al. Long-term prognosis after elective AAA is poor in women and men: the challenges remain. Annals of Surgery, in press, 2020, PMID: 32657926. 2. Smedberg C, Steuer J, Leander K, Hultgren R. Incidence, time trends and sex differences in aortic dissection: a population based study on Swedish patients during 15 years. European Heart Journal, Volume 41, Issue 26, Pages 2430–2438 e-pub June 2020. 3. Ulug P, Sweeting MJ, von Allmen RS, et al. Morphological suitability for endovascular repair, non-intervention rates, and operative mortality in women and men assessed for intact abdominal aortic aneurysm repair: systematic reviews with metaanalysis. Lancet 2017 Jun 24;389(10088):2482–2491. doi: 10.1016/S0140–6736(17)30639-6. PMID: 28455148 Review. 4. Wanhainen A, Verzini F, Van Herzeele I, et al. Editor’s Choice – European Society for Vascular Surgery (ESVS) 2019 Clinical Practice Guidelines on the Management of Abdominal Aorto-iliac Artery Aneurysms. European Journal of Vascular and Endovascular Surgery 2019 Jan;57(1):8–93. doi: 10.1016/j.ejvs.2018.09.020, PMID: 30528142. 5. Sakahalisan N, Defraigne J, Katsargyris A, et al. Abdominal Aortic Aneurysms. Nature Reviews Disease Primers 2018 Vol 4:1 34. 6. Lo RC, Lu B, Fokkema MT, et al. Relative importance of aneurysm diameter and body size for predicting abdominal aortic aneurysm rupture in men and women. Journal of Vascular Surgery 2014 May;59(5):1209–16. doi: 10.1016/j.jvs.2013.10.104. Epub 2013 Dec 30.PMID: 24388278. 7. Hultgren R, Linne A, Svensjö S. Cost effectiveness of targeted screening of siblings to individuals with abdominal aortic aneurysms. British Journal of Surgery 2019 Feb;106(3):206–216. doi: 10.1002/ bjs.11047. PMID:30702746. 8. Villard C and Hultgren R. Abdominal aortic aneurysm – sex differences. Maturitas e-pub January, April 2018, 109, p 63–69. 9. Zommorodi, Bottai and Hultgren. Sex differences in repair rates and outcome in patients with ruptured abdominal aortic aneurysm – a nationwide propensity-score-matched analysis of 10,724 patients. e-published British Journal of Surgery 2019 Oct;106(11):1480–1487. PMID 31403186. 10. Fattahi, Rosenblad, Kragsterman, et al. Risk factors in 50-year-old men predicting development of abdominal aortic aneurysm – a prospective cohort study with 15 years of follow-up. Journal of Vascular Surgery 2020 Febr 27, PMID 32115319. 11. Hultgren, Elfström, Öhman, et al. Six-year follow up in men invited to a population-based abdominal aortic aneurysm screening program. Angiology, volume 71 Issue 7, 641–649 e-pub 2020. 12. Ulug P, Powell JT, Warschkow R, et al. Sex specific differences in the management of descending thoracic aortic aneurysms: systematic review with meta-analysis. European Journal of Vascular and Endovascular Surgery 2019 Oct;58(4):503–511. doi: 10.1016/j.ejvs.2019.04.022. 13. Thompson SG, Bown MJ, Glover MJ, et al. Screening women aged 65 years or over for abdominal aortic aneurysm: a modelling study and health economic evaluation. Health Technol Assess 2018 Aug;22(43):1–142. doi: 10.3310/hta22430. PMID: 30132754.
Rebecka Hultgren is an adjunct professor at Karolinska Institutet and senior consultant in the Department of Vascular Surgery at Karolinska University Hospital (Stockholm, Sweden). The author has no disclosures.
November 2020 | Issue 88
26 Thoracoabdominal repair
CX AORTIC VIENNA
Inaugural CX Aortic Vienna sees lively discussion on thoracic endograft and thoracoabdominal repair In the final session of the inaugural CX Aortic Vienna meeting, Maarit Venermo (Helsinki, Finland), and Roberto Chiesa (Milan, Italy) steered the audience through animated discussion on thoracic endografts and thoracoabdominal repair. JASON LEE (STANFORD, USA) AND ALI Khoynezhad (Manhattan Beach, USA) took part in a CX debate on the following motion: snorkels and parallel endografts enabling perfusion of branch vessels and extensions of endograft utility along the whole thoracoabdominal aorta are useful. Lee argued in favour of the motion, and Khoynezhad against. In Lee’s eyes, snorkel, chimney, periscope, and sandwich techniques are “likely all here to stay,” particularly when it comes to urgent cases, bailout, and difficult anatomy “that cannot be managed with commercially-available, current devices in the USA”. Arguing against this, Khoynezhad told the listening audience that parallel grafting “has many pitfalls and complications”, and shared that this method comes with a higher mortality when compared to a propensity-matched cohort. “Parallel grafts are an acceptable approach in emergency cases or as a bailout manoeuvre,” he concluded.
Audience vote snorkles and parallel endografts are useful, but not the best option Audience polling conducted after the debate revealed that while 83% of the audience believe snorkles and endografts enabling perfusion of branch vessels and extensions of endograft utility along the whole thoracoabdominal aorta are useful, 82% believe they are not the best method. Following the debate, Roman Gottardi (Salzburg,
In response to the question “Can we safely predict when not to use spinal cord drainage?” a majority [88%] voted “no”. Austria) provided a summary of the current trends in reduction or elimination of aortic impulse during stent graft deployment and balloon moulding in TEVAR. According to Gottardi, the preferred methods of reduction and elimination of aortic impulse during TEVAR are rapid right ventricular pacing and pharmacologic blood pressure lowering, which are less frequently used for balloon moulding.
Spinal cord ischaemia and the place of cerebrospinal fluid drainage addressed
Turning to spinal cord ischaemia in the context of thoracoabdominal repair, Gustavo Oderich (Houston, USA) spoke to the CX Aortic Vienna audience that cerebrospinal fluid drainage “is a key component of treatment of spinal cord injury”, but noted that evidence for efficacy of routine prophylactic drainage is “at best weak”. He called for a prospective randomised study of prophylactic versus rescue cerebrospinal fluid drainage. Anchor chair Roger Greenhalgh (London, UK)
remarked that it was not the first time this had been said, citing similar discussions in previous years with the likes of Stanley Crawford. Corinna Walter (Vienna, Austria) spoke next, discussing perioperative antithrombotic management and cerebrospinal fluid drainage in TEVAR. The more extensive the aortic coverage in any form of EVAR, the greater the risk of spinal cord ischaemia, she explained, adding that “There are multiple different approaches to reduce the risk of spinal cord ischaemia.” As described in detail in her talk, the team of which Walter is part have been successfully employing an antithrombotic regimen to minimise this risk, and she reported a 96% patency rate of visceral stent grafts “without a single case of spinal haematoma”—no cerebrospinal fluid drainage, and no catheter-related bleeding complications. Having heard about the challenges presented by spinal cord ischaemia, the CX Aortic Vienna audience were given a presentation delineating the “best protocol” for preventing the complication. Wrapping up the online conference, Germano Melissano (Milan, Italy) related how spinal cord ischaemia is “multifactorial”, and that its prevention “requires optimising all aspects of procedures”. However, after detailing the steps his institution implements to avoid spinal cord ischaemia, he concluded that, while cerebrospinal fluid drainage is a valid adjunct, “it comes with several potential serious complications. The problem is not yet solved,” he said, “more research is needed.” In response to a final poll that concluded the session, asking the audience “Can we safely predict when not to use spinal cord drainage?” a majority (88%) voted “no”.
“Are we making a difference [concerning long-term survival] with F/BEVAR?” He believes so, telling delegates that F/BEVAR “has improved survival compared to non-operative management in most patients, even in a high-risk patient population”. Frans Moll (Utrecht, The Netherlands) argued that a more compliant thoracic stent graft is needed. “Aortic stiffening is known to play an important role in cardiovascular disease,” he said, “and as we know, endografts induce stiffening of the aorta.” He concluded: “To overcome this issue, medical device manufacturers should work hand-in-hand with the surgeons to develop more compliant devices to reduce this stiffness mismatch with the aorta, especially when treating aortic pathologies in the proximal aorta, close to the aortic valve and in younger patient populations. This is an important issue to work on in the near.” Andrea Kahlberg (Milan, Italy) next shared his experience of more than 300 TEVAR procedures using the Zenith Alpha thoracic stent graft (Cook Medical), a low-profile modular endograft system. Kahlberg shared how this stent graft allowed his team to extend indications to patients with severe access problems, enabling safe passage through calcified and tortuous vessels. “It retains the precision and control of the previous generation device, but with higher conformability,” he enthused. “It has provided satisfactory mid-term results in our singlecentre series.” Discussing branched endografts for rupture chronic thoracoabdominal dissections, Stéphan Haulon (Paris, France) next took to the online podium. “I think that highvolume centres should be able to perform both techniques; open and endovascular repair of chronic dissections,” he said. “When using T-branch in chronic dissections, you need vast experience with complex iliac branch and fenestrated endografting,” he recommended. “Zone two extension is needed in up to 60% of TEVAR patients,” Gustavo Oderich (Houston, USA) concluded in his talk on left subclavian artery preservation during thoracic endovascular repair. Sharing his preliminary experience with left subclavian artery branch devices, he showed how these early results indicate low morbidity and stroke rates with high patency rates. He reminded delegates that left subclavian artery coverage without revascularisation is associated with higher risk of arm ischaemia, posterior circulation events, and spinal cord injury. Fabio Verzini (Turin, Italy) presented on fenestrated and branched endografting for postdissection thoracoabdominal aneurysms. “Thoracic endografting has been used as a minimally invasive solution for chronic type B aortic dissection, with favourable early results,” he said. “Unfortunately, high risk of late reintervention has been found, ranging from between 0 and 20%.”
83%
Further discussion: Thoracic endograft and throracoabdominal repair Alexander Zimmermann (Zurich, Switzerland) and Marek Ehrlich (Vienna, Austria) moderated another session on thoracic endograft and thoracoabdominal repair. Matt Eagleton (Boston, USA), programme committee co-chair of the Society for Vascular Surgery (SVS), asked the CX Aortic Vienna audience
While 83% of the audience believe snorkles and endografts enabling perfusion of branch vessels and extensions of endograft utility along the whole thoracoabdominal aorta are useful, 82% believe they are not the best method
82%
Issue 88 | November 2020
Fragile aortas 27
Polling at CX Aortic Vienna shows desire for fragile aortaspecific stent grafts Use of a specifically designed stent graft to treat a fragile aorta was backed by three quarters of the CX Aortic Vienna audience, polled during a session on the timing of intervention in thoracic aortic dissection.
S
téphan Haulon (Paris, France) and Roberto Chiesa (Milan, Italy) moderated the discussion, during which the audience viewed an edited case involving a new stent graft, the Valiant Navion (Medtronic), designed with specific features for fragile aorta pathologies. Attendees also heard during the session that timing of thoracic endovcascular aortic repair (TEVAR) is a “balance between early procedural risk and promotion of aortic remodelling,” while the merits of early intervention were also considered. Opening the session, Mark Farber (Chapel Hill, United States) addressed several misconceptions and controversies concerning the treatment of chronic type B aortic dissection, in a presentation on the management of chronic dissections with fenestrated or branched endovascular aortic devices. Farber challenged the assertions that TEVAR alone is successful in treating the condition, that small true
lumen will not allow expansion of devices, and that problems exist if the natural fenestrations are not aligned or small. He also presented data comparing endovascular outcomes of post-dissection and degenerative thoracoabdominal aneurysms. Ali Azizzadeh (Los Angeles, USA), gave CX Aortic Vienna attendees a detailed overview of the parameters for understanding windows of success in type B aortic dissection. During the presentation, he outlined recently revised temporal classifications of aortic dissection, discussed the predictors of intervention and mortality in patients with uncomplicated acute type b and considered research on the influence of timing after thoracic endovascular aortic repair for acute type B aortic dissection. Taking all of the data together, he concluded that there is growing evidence that optimal timing of TEVAR decreases risk of complications. According to Ian Loftus (London,
CX Aortic Vienna audience agree sac diameter is of crucial importance in postEVAR surveillance During the CX Aortic Vienna sac size and endovascular aneurysm repair (EVAR) follow-up session, polling revealed that 94% of the audience agreed with the statement “The only thing that matters in post-EVAR surveillance is sac diameter”. THIS RESULT FOLLOWED A PRESENTATION by Ian Loftus (London, UK), who showed data supporting this claim. “A large proportion of aneurysms fail to shrink, despite endovascular intervention, and this correlated with a poorer longterm survival,” he explained. “Whilst the rupture risk is important and needs to be reduced to a minimum, excess cardiovascular risk is also vital and should be a target of our surveillance programme. Furthermore, sac expansion should be deemed a therapeutic failure.” Loftus added that surveillance programmes are currently “largely ineffective”. He argued that things need to change, and stressed the importance of an individualised, ultrasound-based approach to patient surveillance. He added that tabletbased ultrasound technologies, which can be taken to the patient, are the way forward. Loftus ended with a nod towards the DETECT (Detection of EVAR sac expansion using ultrasound surveillance) study,
UK), timing of TEVAR is a balance between early procedural risk and promotion of aortic remodelling. In his presentation, Loftus made a case for reviewing the timing of intervention for type B dissections, and called for more treatment of the condition during the acute phase. Many practice delaying TEVAR until a subacute period, he said, noting that this has significant implications for services and resources. Loftus discussed data on the timing of TEVAR—taken from the VIRTUE registry—showing that intervention in the subacute period had a 0% mortality rate, compared to 8% in the acute phase. In his concluding remarks, Loftus said: “Contemporary data support more intervention in the acute phase.” Frank Vermassen (Ghent, Belgium) focused his presentation on whether early treatment of aortic dissection could be considered as a definitive solution. It is generally accepted that in acute type B dissection there should be a difference between complicated and uncomplicated cases, he remarked.
which will look specifically at the use of a novel tablet technology and sac size increase. Andres Schanzer (Worcester, USA) posited that aneurysm sac behaviour is associated with longterm survival, and that not only sac expansion, but any failure of the sac to regress, is associated with lower long-term survival. Finally, he noted that a decrease in long-term survival effect is independent of identification of endoleak. “We need to better understand if complete aneurysm exclusion is adequate treatment for aneurysm disease,” Schanzer told registrants. Considering why sac retraction is an important issue after EVAR, Jean-Pierre Becquemin was next to address the CX Aortic Vienna audience. “Since the beginning of EVAR treatment,” he began, “the search for endoleak was the main purpose of postoperative surveillance”. However, Becquemin concluded that diameter, more than endoleak, is a key factor of surveillance, detailing that failure of sac retraction and/or enlargement is associated with impaired overall survival, aneurysm-related survival, more complications, and the need for reintervention. Maarit Venermo (Helsinki, Finland) talked about the
Clockwise from top left: Roger Greenhalgh, Afshin Assadian, Alexander Zimmermann, Mari Murumets, Jeffrey Jim, and Maarit Venermo
Continuing pain, acute dilatation or expansion, branch vessel malperfusion, and rupture are classically considered as indications for early intervention, Vermassen added, noting that findings from the INSTEAD XL study show that even after TEVAR, progression of the disease occurs in almost 30% of patients. Vermassen opened the ensuing discussion by concluding that early treatment of aortic dissection is not a definitive solution. Theodoros Kratimenos (Athens, Greece) discussed the treatment of the fragile aorta, presenting an edited case involving the Valiant Navion device. He noted that there is a clinical need for an endograft with specific features to treat broad aortic pathologies, and he discussed the features and configurations of the Valiant Navion device and its particular features for fragile aorta pathologies. Kratimenos commented that the device is a suitable choice for the treatment of fragile aortas, minimising disruption to the native vessel, but said that a post market registry will be started to better understand outcomes regarding these complex patient populations. Ross Milner (Chicago, USA) discussed existing studies to have assessed the Valiant Navion and detailed the ongoing DISSECT-N Global TEVAR registry, which will enrol around 200 subjects, to be followed for three years’ post-procedure.
Helsinki University Hospital experience of ultrasound surveillance after EVAR. The team began using ultrasound for this purpose in 2011 and have found it to be non-inferior to CT surveillance. Over 10 years, the study group also found that with the new protocol of ultrasound surveillance, there was less radiation, and it was more cost-effective. Jeffrey Jim (Minneapolis, USA) considered how stent graft design influences overall abdominal aortic aneurysm (AAA) sac dynamics and overall therapy success, and, more specifically, how this applies with respect to the Endurant device (Medtronic). Successful abdominal aortic aneurysm (AAA) therapy with stent grafts have traditionally been determined by factors including freedom from mortality and the absence of endoleaks. However, sac regression and the negative impact of endoleaks on sac regression are now known and important factors, Jim stressed. “The design features of the Endurant likely have an impact on sac dynamics and therapy success,” he stated, concluding that “endograft design plays an important role in success of endovascular AAA therapy and this is something that all practitioners should consider for their patients”. Prompting discussion among the panellists, Martelli Massimiliano from Lugano, Switzerland, asked: “What is the relevant millimetre increase in sac diameter?” to which the consensus response was somewhere around 5mm. Following extensive dialogue on the importance of sac diameter, Mari Murumets (London, UK) discussed the technical aspects of reliable aortic sac diameter measurement by ultrasound, covering the limitation of ultrasound, common mistakes, how to minimise errors, and remaining challenges. Murumets covered topics including image resolution, sac measurement, and image acquisition.
CONTROVERSIES
CHALLENGES
CONSENSUS
Vascular & Endovascular
Controversies Update
19–22 APRIL 2021 MONDAY-THURSDAY Aortic Controversies
Peripheral Arterial Controversies
Venous & Lymphatic Controversies
Acute Stroke Controversies
Vascular Access Controversies
Controversies
DIGITAL EDITION WWW.CXSYMPOSIUM.COM CX 2021 will be streamed live daily with audience participation, discussion and polling
EDUCATION
INNOVATION
EVIDENCE
Issue 88 | November 2020
Aortic imaging 29
CX AORTIC VIENNA
Aortic imaging session at CX Aortic Vienna reveals universal preoccupation with radiation reduction, and showcases the latest in CT technology Polling at CX Aortic Vienna points to a high level of vigilance over radiation exposure during endovascular aneurysm repair (EVAR). This was among the messages to emerge from a discussion on the optimal use of aortic imaging for diagnostic purposes and to influence operative results, with a session on the topic split between examining thoracic and EVAR imaging.
Majority of the audience would not use IVUS to diagnose complex aortic conditions
The role of thoracic imaging and planning in revealing underlying thoracic aortic pathology was the initial focus of the session, with Frank Vermassen (Ghent, Belgium) opening on the topic of intramural haematomas and penetrating aortic ulcers, “two less common aortic pathologies,” in his words. “Being pathologies of the aortic wall, they are intimately related to each other, and to aortic dissection,” he informed viewers. Vermassen’s presentation focused on the diagnosis of both conditions, with intramural haematoma signposted by similar symptoms to those of acute aortic dissection, he said, and thoracic pain often a giveaway of a penetrating aortic ulcer. “Sometimes, even rupture can be the first sign,” Vermassen said. “Diagnosis is mostly made on CT scans, showing a focal or crater-like outpouching in the atherosclerotic wall with subintimal haematoma mostly in the descending aorta.” Medical management and serial follow-up are indicated in uncomplicated intramural haematoma/penetrating aortic dissection, he noted, adding that thoracic endovascular aortic repair (TEVAR) is the treatment of choice in complicated cases. Following Vermassen’s talk, the audience was asked to vote upon the use of intravascular ultrasound (IVUS) for diagnosis of the condition—with 75% suggesting they would not employ this technique.
Transection must be ruled out in cases of blunt thoracic aortic injury
Ali Azizzadeh (Los Angeles, USA) then took to the online podium to discuss the medical management of blunt thoracic aortic injury, viewed through the lens of the Aortic Trauma Foundation global registry. He believes that these most
recent data support the revision of the current Society for Vascular Surgery (SVS) clinical practice guidelines for the management of Grade II traumatic aortic injury. Azzizadeh told the CX Aortic Vienna audience that medical management “appears to be safe and effective, with a low overall intervention rate and no aortic-related deaths”. Polling then revealed that 86% of attendees agreed that aortic transection must be ruled out in such cases. Opening the EVAR-specific side of the aortic imaging session, Franco Grego (Padua, Italy) argued in favour of using a relatively new, systematic, preoperative cardiac evaluation in patients undergoing abdominal aortic aneurysm repair, as opposed to following the American Heart Association (AHA) and European Society of Cardiology (ESC)/European Society of Anaesthesiology (ESA) guidelines. Grego relayed findings of a retrospective study on patients with infrarenal abdominal aortic aneurysm undergoing elective repair, with both endovascular and open treatments included. “I think that a systematic, preoperative cardiac consultation can improve all our patients’ follow-up, reducing late cardiac-related morbidity and mortality, and therefore improving their lives,” he concluded.
Dynamic CT the “gold standard” for endoleak management
“Dynamic CT should be considered
the gold standard in troubleshooting endoleaks and guidance of therapy,” Alan Lumsden (Houston, USA) argued at CX Aortic Vienna. He called for a “dynamic CT for a dynamic process”. He went on to say that “the problem with magnetic resonance imaging [MRI] is that it requires a lot of expensive hardware [and] a lot of additional
working on. “Our vision for intelligent planning is bringing capabilities together such that each new case is informed by all previous similar cases globally, and each new case contributes to the planning of future cases. Review metrics will allow you to have some quantitative measures to assess the outcome of the patient to help you with
100%
YES Polling asked attendees whether 15-year EVAR follow-up results had led them to try to reduce radiation, to which 100% responded ‘yes’ expertise. CT, on the other hand, is generally much more applicable and available,” he opined. “The question is, can we acquire the same kind of images using CT?” Demonstrating through multiple videos the sorts of “images” dynamic CT is able to produce, Lumsden highlighted the improved spatial resolution made possible by this technology. Tom Carrell (Barrington, UK) next gave audience members an understanding of how physicians plan, navigate, and review EVAR cases today, and offered his insights into the future of this space, speaking as co-founder of Cydar Medical, a company that using cloud computing and artificial intelligence to improve image-guided surgery. Inviting the CX Aortic Vienna audience to “watch this space”, Carrell left viewers with an idea of the things the team at Cydar Medical are currently
The problem with magnetic resonance imaging [MRI] is that it requires a lot of expensive hardware [and] a lot of additional expertise. CT, on the other hand, is generally much more applicable and available.”
risk stratification when deciding on follow-up.”
Long-term EVAR results have prompted action to reduce radiation, polling finds
Maani Hakimi (Lucerne, Switzerland) presented a Siemens Healthineerssponsored edited case, demonstrating how to reduce radiation exposure during an EVAR, “an important goal during endovascular procedures”. “Preoperative planning and strategy is the key to success for the implementation of dose reduction,” he informed attendees of the online conference. “It has been proven that a standardised protocol and the use of a navigation system are necessary.” Hakimi added that by using a low-dose software programme, radiation exposure can be further reduced. Polling at the end of the session asked attendees whether 15-year EVAR follow-up results had led them to try to reduce radiation, to which 100% responded “yes”. The result was described as “terribly important” by chair Roger Greenhalgh (London, UK). The result also prompted Lumsden to criticise current practice for monitoring radiation exposure among physicians, commenting: “Our methods of radiation monitoring are prehistoric—we need to move into the modern day.”
Issue 88 | November 2020
Abdominal aortic aneurysm 31
AORTIC
Study identifies new genetic factors associated with AAA risk The American Heart Association (AHA) recently announced the publication of a study identifying 14 new genes linked to an increased risk of abdominal aortic aneurysm (AAA). PREVIOUS STUDIES HAVE detected 10 locations in the human genome associated with potential risks. But this new work, published in the AHA’s journal Circulation, more than doubled that number, to a total of 24 genetic factors associated with abdominal aortic aneurysm. “This new information can enhance screening protocols and help identify individuals at risk for abdominal aortic aneurysm,” one of the study’s authors, Philip S Tsao (Stanford University School of Medicine, Stanford, USA; VA Palo Alto Health Care System, Palo Alto, USA) said in a news release. According to the AHA, the study used the world’s largest genetic biobank, the Million Veteran Program, which was created in 2011 to study how genes affect the health of US military veterans. Researchers tested about 18 million DNA sequence variants among more than 7,500 abdominal aortic aneurysm
cases and 172,000 veterans who did not have the condition. The work factored in the effects of blood pressure, finding that a genetic predisposition for an increase of 10 mmHg in diastolic blood pressure increased the risk. “We were surprised that diastolic blood pressure, as opposed to systolic blood pressure, is likely of greater significance in the development of abdominal aortic aneurysm,” Tsao said. The data also showed that 19 of the 24 genetic risk variants for the condition pointed to an increased risk for aneurysms in other parts of the body. Researchers created a “polygenic risk score” that helped identify groups of people more likely to develop abdominal aortic aneurysms, regardless of known risk factors such as smoking and family history. The authors acknowledge that their study should be interpreted within
the content of its limitations. “First, our AAA phenotype is based on HER [electronic health record] data and may result in misclassification of case status,” they write in Circulation. However, they add that such classification should reduce statistical power for discovery and on average bias results towards the null. Second, they recognise that although those with the highest polygenic risk score (PRS) are at an increased risk for AAA, the PRS mechanism of action represents a combination of many causal risk factors, rather than a single pathway that leads to disease. “However,” they
10
LOCATIONS
According to a recent analysis, the decision to delay operative repair of abdominal aortic aneurysm (AAA) should consider both patient age and local COVID-19 prevalence in addition to aneurysm size. Furthermore, endovascular aneurysm repair (EVAR) should be considered when possible due to a reduced risk of harm and lower resource utilisation.
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24
INDENTIFIED
Previous studies have detected 10 locations in the human genome associated with AAA risk; this new study identified 24
Analysis suggests reassessment of operative threshold for AAA repair during COVID-19
riting in the Journal of Vascular Surgery, Brandon McGuinness (McMaster University, Hamilton General Hospital, Hamilton, Canada) and colleagues note that the worldwide COVID-19 pandemic has forced healthcare systems to delay elective operations. The present study provides a structured analysis of the decision to delay AAA repair and quantify the potential for harm. The investigators constructed a decision tree modelling immediate repair of AAA relative to initial non-operative (delayed repair) approach. They considered risk of COVID-19 contraction and mortality, aneurysm rupture, and operative mortality. McGuinness and colleagues performed a deterministic sensitivity analysis for a range of patient ages (50 to >80), probability of COVID-19 infection (0.01–30%), aneurysm size (5.5–>7cm), and time horizons (3–9 months). They also conducted probabilistic sensitivity analyses (PSA) for three representative ages (60, 70, 80), and analyses for EVAR and open surgical repair. McGuinness et al report that patients with aneurysms
note, “assessment of individual risk can aid in identifying those at highest risk for AAA and more likely to obtain benefit from screening, regardless of mechanism”. Finally, they observe that the Veterans Health Administration healthcare system contains a much higher proportion of men than the general population, and so recognise that their ability to detect female-specific associations was more limited. That being said, they write that AAA is a disease process that “overwhelmingly affects men,” and so their results “should therefore still be generalisable to patients with AAA”.
7cm or greater demonstrated a higher probability of survival when treated with immediate EVAR or open surgical repair, compared to delayed repair, for patients under 80 years of age. When considering EVAR for aneurysms 5.5–6.9cm, immediate repair had a higher probability of survival except in settings with high probability of COVID-19 infection (10–30%) and advanced age (70–85+ years). A non-operative strategy maximised the probability of survival as patient age or operative risk increased. Probabilistic sensitivity analyses demonstrated that
It is important to focus on more than aneurysm size when deciding to delay operative repair of a AAA.”
patients with large aneurysms (>7cm) faced a 5.4–7.7% absolute increase in the probability of mortality with a delay of repair of three months. in addition, young patients (60–70 years) with 6–6.9cm aneurysms demonstrated an elevated risk of mortality (1.5–1.9%) with a delay of more than three months. Those with 5–5.9cm aneurysms demonstrated an increased survival with immediate repair in young patients (60), however this was small in magnitude (0.2–0.8%). Finally, they state that the potential for harm increased as length of surgical delay increased. For elderly patients requiring open surgical repair, in the content of endemic COVID-19, delay of repair improves probability of survival. Speaking to Vascular News, McGuinness comments on the study findings: “It is important to focus on more than aneurysm size when deciding to delay operative repair of a AAA. Practitioners need to consider the risk their patient faces of perioperative mortality as well as COVID-related mortality.” He adds: “Patients with low operative risk stand to gain the greatest net benefit from operative repair. If they are young and at a low risk of COVIDrelated mortality, they take on a greater risk with delay of surgery. This paper aims to contextualise these other considerations that should go into decision making along with aneurysm size.” The authors do acknowledge, however, the “constantly evolving” nature of the pandemic and warn that the length of time these recommendations are applicable to practice is “hard to Brandon predict”. McGuinness
November 2020 | Issue 88
32 Journal coverage
VENOUS
Comparable risk of recurrent VTE between patients with unprovoked VTE and patients with cancer Patients with venous thromboembolism (VTE) carry a high risk of recurrence. Accordingly, a 16-year Danish prospective cohort study of nearly 74,000 patients with incident VTE concluded that the risk of recurrence is substantial. Furthermore, the scientists found that the recurrence risk is similar for patients with cancer and patients with unprovoked VTE, reports The American Journal of Medicine. VTE, COMPRISING DEEP VEIN THROMBOSIS and pulmonary embolism, is the third most common cardiovascular disease after myocardial infarction and stroke. Historical trials have reported a cumulative recurrence risk of nearly 40% after 10 years with associated high mortality. Recurrent VTE is largely preventable if patients receive extended duration anticoagulation therapy, but the protective effect must
be carefully weighed against the risk of anticoagulantrelated bleeding. “Optimal duration of anticoagulation is a pivotal and an ongoing scientific and clinical concern,” explained lead investigator Ida Ehlers Albertsen of the Department of Cardiology, Aalborg University Hospital, and Aalborg Thrombosis Research Unit, Aalborg University, Aalborg, Denmark. “The emergence of the non-vitamin K antagonist oral anticoagulants has changed the landscape for prevention of thrombosis, and contemporary risk stratification approaches may need to be adjusted according to these effective and safer agents.” The study investigated the risk of recurrence after incident VTE stratified according to provoked, unprovoked, and cancerrelated VTE in a group of close to 74,000 routine care Danish in- and outpatients. Researchers linked nationwide Danish health registries to identify all patients with incident VTE from January 2000 through December 2015. The study revealed a ten-year cumulative incidence of more than 15% for all groups, indicating a substantial risk of recurrence for all patients with VTE, even in a contemporary clinical setting.
Study shows early treatment for leg ulcers leads to better outcomes for patients To deliver clinical and cost benefits, leg ulcer care pathways should be revised to include early assessment and treatment of superficial venous reflux, researchers behind a recent Journal of the American Medical Association (JAMA) Surgery study suggest.
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he investigators set out to determine the clinical and costeffectiveness of early endovenous ablation of reflux in patients with venous leg ulceration and superficial reflux. They conducted a 450-patient, multicentre, randomised clinical trial, which found that early endovenous ablation with compression accelerated venous ulcer healing, reduced the overall incidence of ulcer recurrence, and was highly cost-effective compared with compression with deferred intervention. In the clinical trial presented in JAMA Surgery, which was led by researchers at Imperial College London and clinicians at Imperial College Healthcare National Health Service (NHS) Trust (London, UK), 450 patients with venous leg ulcers were treated with early surgical interventions. This resulted in faster healing and a reduced risk of the condition coming back compared with current methods
of treating patients with compression stockings and delayed surgical interventions. They recommend that guidelines on treating leg ulcers should be revised to include early assessment of varicose veins and surgical treatment of leg ulcers to deliver clinical benefits and cost savings for the NHS. The authors
We believe that the current guidelines should be changed so that patients with leg ulcers are treated with surgery at an earlier stage.”
At 10-year follow-up, patients with unprovoked VTE (without cancer or any provoking factor) and cancer patients had the highest risk of recurrence compared with patients with provoked VTE. “Our concept of VTE is undergoing a major transition as we increasingly consider it as a chronic illness,” commented co-investigator Samuel Zachary Goldhaber of the Division of Cardiovascular Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, USA. “Ideally, stratification based upon well-defined risk factors should consistently identify patients needing continued treatment and, conversely, patients who can be safely managed with shorter time-limited treatment.” “Given the high risk of recurrence among all the types of incident VTE, it is worth discussing if the current recommended treatment duration after VTE according to clinical guidelines is optimal,” noted Albertsen. “To optimise duration of anticoagulation, we may need to rethink the arbitrary categorisation of provoked/unprovoked when risk stratifying patients with incident VTE and aim for more nuanced risk stratification.”
Our concept of VTE is undergoing a major transition as we increasingly consider it as a chronic illness .”
also suggest that this early treatment intervention could save the NHS an estimated £100 million per year. Lead author of the study Alun Davies (Imperial College London; Imperial College Healthcare NHS Trust, London, UK) says: “Venous leg ulcers cause enormous physical and mental distress to patients as well as having a financial impact on the NHS. Our study is the first to show that early surgical treatment of leg ulcers leads to faster healing and the reduced risk of the ulcer coming back compared to current methods. “The NHS spends around 2% of its budget on managing lower limb wounds and there is an urgent need to find more effective treatments. We believe that the current guidelines should be changed so that patients with leg ulcers are treated with surgery at an earlier stage. This approach will lead to better outcomes and improve patients’ quality of life.” The main treatment for leg ulcers is compression bandages or stockings, to improve the vein function in the legs. There are also surgical treatments, such as endovenous ablation. However, under current guidelines, this treatment is not usually offered until the ulcer has been present for many months, if at all. Furthermore, if the underlying cause of the ulcer is not treated, there is a high risk of the ulcer coming back after treatment. The researchers wanted to see whether performing endovenous ablation to treat varicose veins at an earlier stage can lead to faster healing and reduce the risk of venous leg ulcers
returning, requiring further treatment. They recruited 450 patients with venous leg ulcers from October 2013 to September 2016. All patients had leg ulcers for less than six months, and were treated at 20 hospitals in the UK, including Imperial College Healthcare NHS Trust hospitals. Two hundred and twenty-four patients were randomly assigned to receive endovenous ablation within two weeks of randomisation followed by wearing compression stockings. The rest of the patients were given compression stockings but the endovenous ablation treatment was delayed by six months or until the ulcer was healed. Of the 426 participants whose leg ulcer had healed, 121 participants experienced at least one recurrence during five-year follow-up. In the early-intervention group, 56 patients experienced recurrence during followup. In comparison, 65 participants in the delayed intervention group experienced recurrence during follow-up. The rate of recurrent ulcers was 60% higher in the deferred intervention group (0.16 per year of follow-up compared to 0.1 per year in the early-intervention group). They also found that healing was shorter in the early intervention compared to the deferred intervention group. The team compared the cost of early surgical intervention with delayed intervention over three years and found that early intervention was, on average, the less costly strategy over that time period.
Issue 88 | November 2020
Key updates 33
Deep vein arterialisation should be considered in “no option” CLTI patients, two-year LimFlow data show Mid-term results from a study of the largest population of patients with no-option chronic limb-threatening ischaemia (CLTI) treated with percutaneous deep vein arterialisation (pDVA) using the LimFlow device show that, in this complex group of patients, this treatment method is feasible, with a high technical success rate and amputation-free survival at six through to 24 months, coupled with effective wound healing. In selected patients with no-option CLTI, percutaneous deep vein arterialisation could be a recommended treatment to prevent amputation and heal wounds, Costantino Del Giudice (Université de Paris, Paris, France) told delegates attending the online 2020 meeting of the Cardiovascular and Radiological Society of Europe (CIRSE; 12–15 September, virtual).
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hese results from the ALPS (midterm outcomes of percutaneous deep venous arterialisation with a dedicated system for patients with no-option chronic limb-threatening ischemia) multicentre study were published in the Journal of Endovascular Therapy in May this year, and appeared in the August print issue, in addition to being presented at the CIRSE congress. The ALPS registry is the largest study to date of no-option CLTI patients treated with the LimFlow system reporting mid- and long-term results, and is a multicentre, retrospective study conducted at centres in Alkmaar, The Netherlands; Leipzig, Germany; Paris, France; and Singapore encompassing 32 end-stage—or “nooption”—CLTI patients. The investigators set out to evaluate the mid-term results of patients suffering from no-option CLTI treated with a dedicated system (the Limflow system) for percutaneous deep venous arterialisation. Thirty-two consecutive CLTI patients (mean age 67±14 years;
20 men) were treated with this method using the Limflow device at four centres between 11 July 2014 and 11 June 2018 and retrospectively analysed. Of all patients, 21 (66%) had diabetes, eight (25%) were on immunosuppression, four (16%) had dialysis-dependent renal failure, nine (28%) had Rutherford category six ischaemia, and 25 (78%) were deemed at high risk of amputation. The primary outcome was amputationfree survival (AFS) at six months. Secondary outcomes were wound healing, limb salvage, and survival at six, 12, and 24 months. Technical success was achieved in 31 patients (96.9%). The median follow-up was 34 months (range 16-63). At six, 12, and 24 months, estimates were 83.9%, 71%, and 67.2% for AFS, 86.8%, 79.8%, and 79.8% for limb salvage, and 36.6%, 68.2%, and 72.7% for complete wound healing, respectively. Median time to complete wound healing was 4.9 months (range 0.5–15). The deep vein arterialisation circuit occluded during follow-up in 21 patients; the median
Society of Interventional Radiology publishes IVC filter guidelines The Society of Interventional Radiology (SIR) recently published new clinical practice guidelines that provide evidencebased recommendations on the use of inferior vena cava (IVC) filters to treat venous thromboembolism (VTE). “THESE GUIDELINES ALLOW PHYSICIANS treating patients at risk of a pulmonary embolism to make evidence-based decisions about the use of IVC filters,” said John A Kaufman (Oregon Health & Science University, Portland, USA), the
time to occlusion was 2.6 months. Reintervention for occlusion was performed in 17 patients: 16 because of unhealed wounds and one for a newly developed ulcer.
Deep vein arterialisation a hope for “no option” patients
“No option” patients are those where no possible endovascular or surgical procedure will help, due to either the absence of a target vessel or thanks to unsuccessful prior interventions. These patients frequently have calcified vessels, diabetes mellitus, dialysis, and/ or long-term corticoid therapy. The risk of amputation and persistent wound is 58% when these patients are treated with conservative therapy, and the risk of death at one-year follow-up is 20%. Deep vein arterialisation aims to improve the blood flow to the foot. “We direct nutritional improvement by reversal of flow through venules,” Del Giudice told the CIRSE audience, describing how deep vein arterialisation works. “This stimulates arteriogenesis, and recruits hibernating collaterals.” The most important step, he shared, is patient selection. “Patients have to have a good heart function, a good life expectancy, foot arteries not treatable by an endovascular or surgical approach, a Rutherford class 5–6, a Wound, Ischaemia, and Foot Infection (Wifi) score of 3, and no infection,” Del Giudice listed. According to the speaker, the Limflow technique is the most commonly used method.
The LimFlow technique: How it works
Del Giudice talked CIRSE registrants through a case demonstrating the use of the LimFlow technique. This first involved performing arteriography and venography scans to aid target vessel selection. Next, the interventionalists
guidelines’ primary author. “Throughout the process, the multidisciplinary team followed a gold-standard methodology to ensure we reached the best possible consensus on VTE patient care.” The guidelines, published in the Journal of Vascular and Interventional Radiology, advise against the routine placement of IVC filters in most VTE cases where patients are being successfully treated with anticoagulants. However, if anticoagulation therapies fail or are not indicated for the patient, IVC filters may be considered if clinical risk factors such as bleeding, vascular injury, device migration and increased risk of recurrent deep vein thrombosis (DVT) are considered and deemed low. When IVC filters are placed, the guidelines recommend a follow-up program to increase retrieval and detect complications. In addition, if patients with retrievable IVC filters are no longer at risk of developing a pulmonary embolism, the guidelines recommend removal unless the risk outweighs the benefits. “With these multidisciplinary guidelines, the authors have removed any inconsistencies and uncertainties older guidelines may have presented
advanced the venous and arterial catheters to the target vessel, where the artery and vein were closest, and created an arteriovenous fistula, bridging the two vessels. Then, they advanced the guidewire along the vessel, using it to push the balloon through the arteriovenous fistula to create a passage. Blood flow is diverted from the blocked artery into the vein to salvage the lower leg. Del Giudice also shared an alternative technique whereby entry in the distal lateral or medial plantar vein from a subintimal channel in the plantar artery can be intentionally pursued as a bailout tactic; this involves pointing the tip of the guidewire opposite to the arterial wall calcifications. Yet another method is the venous arterialisation simplified technique (VAST). This utilises a low-profile balloon catheter and a snare to facilitate arteriovenous fistula creation during venous arterialisation. An arteriovenous fistula could also be created using a low-profile balloon catheter and an outback catheter. Del Giudice described a case where he and his team treated a patient using this method, explaining how the patient had occlusion of the popliteal artery. “Without any target vessel in the distal leg,” he said, “we performed subintimal ligation towards the posterior tibial artery, and then we used the outback [catheter] to advance the balloon into the posterior tibial vein, and create the [arteriovenous] fistula, advancing the guidewire. Finally, we performed a valvotomy with a low-profile balloon, and stented the vein from the ankle to the arteriovenous fistula.” Showing a table comparing the outcomes at six months from these different techniques, Del Giudice was positive: “There is good primary patency, ranging from 40–90% at six months, and good wound healing outcomes, ranging from 40–100%.
physicians treating patients with VTE,” said SIR president Michael D Dake (University of Arizona Health Sciences, Tucson, USA). “The authors should be proud of this achievement.” This is SIR’s first official clinical practice guideline, developed using gold-standard guideline methodology following the Standards for Trustworthy Clinical Practice Guidelines set by the National Academy of Medicine. SIR is committed to continuing developing evidence-based clinical practice guidelines to optimise patient care and improve patient outcomes. The guidelines were developed in collaboration with and endorsed by the American College of Cardiology, the American Heart Association/ American Stroke Association, American College of Surgeons (Committee on Trauma), American College of Chest Physicians (CHEST), Society for Vascular Medicine, Society for Vascular Surgery. The Canadian Association for Interventional Radiology and Cardiovascular and the Interventional Radiological Society of Europe have also endorsed the guidelines. The American Society of Hematology has affirmed the value of the statement.
November 2020 | Issue 88
34 Market watch
Clinical News
Endurant
Sac regression with Endurant is associated with decreased risk of all-cause mortality
“Sac regression should be the new paradigm of success after EVAR [endovascular aneurysm repair],” concluded Dittmar Böckler (University of Heidelberg, Heidelberg, Germany) at the European Society for Vascular Surgery 2020 annual meeting (ESVS Month; 29 September–29 October, virtual). New data from the ENGAGE (OUS) real-world, global post-market registry evaluating the safety and effectiveness of the Medtronic Endurant stent graft system demonstrated that sac regression at one year (n=441) with Endurant is associated with decreased risk of allcause mortality through five years. Through five years, freedom from all-cause mortality among subjects whose sac diameter decreased at one year (n=441) was significantly higher (80% vs. 71.9%) compared to subjects whose sac diameter remained stable at one year (n=462) and compared to subjects whose sac diameter increased at one year (62.6% FF all-cause mortality, n=46). Furthermore, it was found that sac regression with Endurant at one year is likely to persist through five years and patients have better outcomes. Results also suggested that stable sacs may not be as benign as once thought. At five years follow-up (n-470), 63.8% of patients treated with Endurant demonstrated a sac diameter decrease, whereas 25.1% and 11.1% of patients treated with Endurant demonstrated stable sac and increasing sac diameters, respectively. Of subjects with sac regression at one year, 86% continue to have sac regression at five years and only 2% have sac increase at five years and 18% have sac increase at five years (n=213).
First two patients enrolled in PRISTINE study with Selution SLR
MedAlliance has announced enrolment of the first two patients in the PRISTINE registry with Selution sustained limus release (SLR) 018 drug-eluting balloon (DEB) for the treatment of patients with below-the-knee disease. This is the first DEB accepted by the US Food
and Drug Administration (FDA) for its breakthrough programme. The PRISTINE registry is a follow up to the encouraging results seen in the PRESTIGE clinical trial (below the knee, chronic limb threatening ischaemia [CLTI]) at six months. PRISTINE is a prospective registry to investigate the safety and efficacy of treatment with Selution SLR sirolimus drug-coated balloon in TASC C and D athero-occlusive infrainguinal disease in patients with CLTI from Singapore. The objective of the registry is to evaluate over 12 months safety and performance outcomes in 75 patients, with Selution SLR DEB in the treatment of infrainguinal occlusive lesions (TASC C and D) in patients with CLTI at Singapore General Hospital. The clinical primary safety endpoint of the registry is freedom from major adverse events through 30 days and the performance primary endpoint is freedom from cd-TLR within six months. The secondary endpoints are primary patency at six and 12 months follow-up, freedom from cd-TLR at 12 months, clinical success at followup in Rutherford score by one class or more, wound healing at six months, and freedom from major target limb amputation within six and 12 months post index procedure. “We are excited about the commencement of this large singlecentre prospective study focusing on patients with chronic limb threatening ischemia receiving the novel sirolimus drug-eluting balloon (Selution SLR DEB) from MedAlliance”, said associate professor Chong Tze Tec, head and senior consultant, Department of Vascular Surgery, Singapore General Hospital. “We believe this registry will give us detailed insight into the efficacy and safety of this new balloon technology which will benefit this challenging group of patients.” “We are delighted to report enrolment of the first two patients in the exciting PRISTINE registry”, added associate professor Tjun Tang, lead Investigator and a senior consultant in the Department of Vascular Surgery, Singapore General Hospital. “CLTI represents the worse part of the spectrum of peripheral artery disease and patients are at an increased risk of limb loss and mortality. The incidence is likely to increase in Singapore because of the rising trend in diabetes and end stage renal disease in the country and these patients are a challenging and frail population of patients. “We currently do far too many major lower limb amputations: in fact the rate in Singapore is two to three times higher than in western countries. We seriously need to address this issue. One of the cornerstones of treatment is to re-establish pulsatile blood flow to the foot to promote wound healing
and although percutaneous lower limb angioplasty has become the favoured option of revascularization, its Achilles heel is vessel recoil and restenosis from neointimal hyperplasia”. “Singapore General Hospital performs over 900 lower limb salvage revascularisation procedures per year and has established multi-disciplinary wound management protocols and we are highly encouraged by the pilot data we have found using this technology so far and PRISTINE will offer further insight, leveraging on our experience with PRESTIGE, whether this sirolimus coated balloon will become an established device in our angioplasty armamentarium in the future”, concluded Tang.
PQ Bypass completes enrolment in DETOUR II pivotal study
Compelling outcomes with TCAR versus CEA in patients with carotid artery stenosis published
Silk Road Medical has announced that positive results from the ongoing TransCarotid Artery Revascularisation (TCAR) Surveillance Project, comparing TCAR with carotid endarterectomy (CEA), have been published in Annals of Surgery. “These results continue to show low in-hospital stroke, death, and combined
stroke/death rates as well as statistically lower rates of in-hospital cranial nerve injury and in-hospital myocardial PQ Bypass has announced enrolment infarction compared to CEA,” says of the final subject in the company’s Mahmoud Malas (San Diego, USA), DETOUR II investigational device chief of vascular and endovascular exemption (IDE) clinical trial. This surgery at UC San Diego Health. milestone occurs only a month after He adds that “these promising the Detour system entered the US Food outcomes will likely increase the role and Drug Administration (FDA)’s of TCAR in the management of carotid breakthrough device programme. artery stenosis.” DETOUR II is led by national coThe study evaluated patients who principal investigators Sean Lyden underwent carotid procedures between (Cleveland Clinic, Cleveland, USA) 2016 and 2019, with 6,384 patients and Jihad Mustapha (Advanced in each group analysed using Cardiac and Vascular Centers, propensity score matching. Grand Rapids, USA). Both TCAR was associated with national co-PIs receive significantly lower rates of incompensation for their duties in hospital myocardial infarction this role. (TCAR, 0.5%; CEA, 0.9%; “The speed with which p=0.005) as well as cranial we were able to enroll nerve injury (TCAR, 0.4%; DETOUR2 in 2020 speaks to CEA, 2.7%, p<0.001). the large patient population Additionally, there were no that exists with long-segment statistical differences noted femoropopliteal disease that between TCAR and CEA for has sub-optimal endovascular in-hospital stroke/death (TCAR, options,” says Lyden. 1.6%; CEA, 1.6%, p=0.945) as “If percutaneous fem-pop well as stroke (TCAR, 1.4%; bypass is shown to be safe CEA, 1.4%, p=0.881) and death and effective, similar to the Detour (TCAR, 0.4%; CEA, 0.3%; outcomes demonstrated in procedure p=0.662). Patients receiving DETOUR1 study, it could be TCAR procedures were also a game changer for the way less likely to stay in the hospital we treat complex, long-segment SFA for more than one day (TCAR, 26.4%; [superficial femoral artery] disease CEA, 30.1%; p<0.001). At one year, the today,” continues Mustapha. incidence of ipsilateral stroke or death DETOUR II is a prospective, was similar between the two groups [HR multicentre trial evaluating the Detour (95%CI):1.09(0.87–1.36), P=0.44]. system for percutaneous femoral“The publication of these data popliteal bypass in patients with in the Annals of Surgery further extremely long, complex lesions in the validates the effectiveness of TCAR SFA. The study enrolled 202 patients in as a treatment option for patients with 36 sites in the USA and Europe, and is carotid artery disease, while highlighting assessing freedom from major adverse the consistency of these data,” says events (MAE) within 30 days of the Erica Rogers, Silk Road Medical’s chief index procedure as the primary safety executive officer. endpoint. The primary effectiveness is The TCAR Surveillance Project, a primary patency at 12 months. key initiative of the Society for Vascular “After finishing enrolment in Surgery’s Vascular Quality Initiative DETOUR II and achieving the (VQI), is an open-ended registry breakthrough device designation, PQ intended to compare real-world patient Bypass is on track to deliver results outcomes between TCAR and other from this study much earlier than what alternatives. we originally expected,” says Heather Simonsen, president of PQ Bypass. “We First patient recruited into a would like to thank the DETOUR II study to obtain the indication investigational sites for their ongoing for a bridging stent in BEVAR contribution to this important research.” procedures
Issue 88 | November 2020
Market watch 35 Switzerland).
Clinical News The first patient has been recruited into a trial investigating the BeGraft peripheral plus stent graft system (Bentley InnoMed) as a dedicated bridging stent in branched endovascular aortic repair (BEVAR) for the treatment of complex aortic aneurysms. It is the first study of its kind worldwide. Martin Austermann (St Franziskus Hospital, and University of Münster, Münster, Germany) is the coordinating investigator of the prospective, single arm, multi-centre clinical study. “Until now, we have not had a dedicated indicated bridging stent to connect branched endografts with renal and visceral arteries,” says Austermann. “There are many devices that could be used for this, but all in an off-label setting.” “It is great news that we could start a trial in collaboration with the Foundation for Cardiovascular Research and Education and Bentley for this indication, it has been an unmet need for such a long time,” he adds. “We are very pleased to run this study, which is approved by the German national competent authority BfArM, together with some other colleagues working in high volume centres in Germany. For us, as endovascular specialists, it is key to work as much as possible with medical devices that are indicated for certain procedures.” Eligible patients are those seeking elective repair of thoracoabdominal aortic aneurysm (TAAA) with BEVAR. The trial aims to carry out 100 BEVAR procedures with an average of 2.5 bridging stents per procedure. The primary efficacy endpoint is comprised of a measure of technical success defined as the successfully introduction and deployment of the BeGraft Plus implanted as a bridging stent in BEVAR, with bridging stent patency at 12 months (absence of restenosis (≥50% stenosis) or sole target vessel occlusion based on computed tomography (CT) angiography at 12 months. The primary safety endpoint at 12 months relates to the absence of procedure-related complications and bridging stent related endoleaks. “In one or two years, the trial will provide us with valuable information on occlusions or stent fracture, for example. We will be able to let the patient know what to expect, and it will make the procedure more predictable,” Austermann comments. The BeGraft Plus combines radial force with flexibility, a Bentley press release states. It consists of two layers of micro-porous expanded polytetrafluoroethylene (ePTFE) tubing based on two cobalt chromium stents and has a sandwich design. The outer ePTFE layer provides fixation of the outer stent and guarantees sealing properties. It also protects the inner ePTFE layer and prevents endoleaks.
The inner PTFE layer provides a sealing of the aneurysm and the inner stent supplies fixation of the inner and outer ePTFE layer. Compared to other available bridging stent grafts, Bentley claims it has an up to 3.5 times higher radial force and is kink-resistant.
CIRSE 2020: New clinical data support use of 4F devices for ambulatory PAD treatment
Outcomes of the BIO4AMB trial demonstrated that ambulatory treatment with 4-French (4F) devices is a valid and safe option for endovascular treatment of lower extremity peripheral arterial disease (PAD), a Biotronik press release reports. In addition, The 4F compatible products showed similar results to 6-French (6F) devices, with the added benefit of an eliminated need for a vascular closure device. These results were presented at the 2020 meeting of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE; 12–15 September, virtual). The BIO4AMB multicentre, controlled trial compared the rate of access site complications and major adverse events in 4F versus 6F femoral access endovascular interventions. The full-cohort analysis of 766 patients showed no significant differences in safety and efficacy between the patient group treated with 6F devices and those treated with Biotronik’s 4F product portfolio. “Compared to the already wellestablished 6F devices, 4F compatible devices were shown to be a valid alternative,” summarised co-principal investigator Marianne Brodmann (Medical University of Graz, Graz, Austria). The rate of freedom from access site complications was 97.2% in the 4F arm and 96.8% in the 6F arm (p=0.734). Brodmann, who presented the data, highlighted a key difference: “Use of 4F sheaths creates 45% smaller puncture holes, which resulted in low rates of access site complications despite not needing vascular closure devices. This may offer a better potential for ambulatory treatment.” The health economic evaluation of the BIO4AMB study, also presented at CIRSE, investigated the implications on safety, resource use and cost of lowerextremity peripheral treatment using 4F and 6F access in an ambulatory setting. In this analysis, the rate of vascular closure device use was 0% in the 4F arm versus 87.4% in the 6F arm (p<0.05). “Depending on the country specific reimbursement situation, ambulatory treatment may offer a cost saving option compared to a stationary setting,” concluded co-principal investigator and presenter Jos van den Berg (Regional Hospital of Lugano, Lugano,
Shape Memory Medical announces first patient enrolment in AAA-SHAPE study
Shape Memory Medical has announced the initiation of AAA-SHAPE, the company’s prospective safety study of the Impede-FX embolisation plug devices when used for abdominal aortic aneurysm (AAA) sac filling during elective endovascular aneurysm repair (EVAR). The study’s first procedure was performed by interventional radiologist Andrew Holden and vascular surgeon Andrew Hill at Auckland City Hospital in Auckland, New Zealand. The Impede-FX embolisation plug is comprised of Shape Memory polymer which is a porous, embolic scaffold. The biocompatible material is crimped for catheter delivery and self-expands to a “memorised” shape upon contact with blood for rapid conversion to organised thrombus. According to a press release, preclinical studies in aneurysm models demonstrated advanced healing of the initial thrombus to mature collagenous connective tissue and aneurysm sac shrinkage. In the USA, the Impede-FX embolisation plug is currently indicated for use with the Impede embolisation plug to obstruct or reduce the rate of blood flow in the peripheral vasculature. In countries recognizing CE marking, the Impede-FX embolisation plug is
Impede-FX, expanded
indicated for use to obstruct or reduce the rate of blood flow in the peripheral vasculature. “We are excited to be part of the AAA-SHAPE study,” said Holden, principal investigator for the study. “The concept of aneurysm sac management in combination with traditional EVAR could address an important unmet need in AAA patients, and we look forward to seeing our follow-up imaging results.” Independent of the AAA-SHAPE study, over 15 cases using Impede-FX for endoleak prevention and AAA sac filling concomitant with EVAR have been reported by Alexander Massmann (Saarland University Medical Center, Homburg/Saar, Germany) and Arne Schwindt (Franziskus Hospital, Münster, Germany). “We are encouraged by our early results, and we believe that clinical studies will be valuable to validate our experience,” said Massmann. “AAA sac expansion following EVAR is a common
complication associated with secondary intervention, rupture, and mortality, and we look forward to exploring the longerterm role of Shape Memory polymer in the management of AAA patients,” added Schwindt.
First patient enrolled in FUTURE SFA study of MagicTouch sirolimus-coated balloon
Concept Medical has announced enrolment of the first patient in the FUTURE SFA (Randomised controlled trial of first sirolimus coated balloon versus standard balloon angioplasty in the treatment of superficial femoral artery and popliteal artery disease) study. The index patient was successfully enrolled on 12 September in Singapore. FUTURE SFA is a randomised, double blind, placebo-controlled, multicentre trial to determine the effectiveness of the MagicTouch PTA sirolimus drugcoated balloon (DCB) versus standard percutaneous transluminal angioplasty for the treatment of superficial femoral and popliteal arterial disease. Sirolimus-coated balloons are considered to be the next new generation of DCBs and the novel MagicTouch PTA sirolimus-coated balloon (SCB), has emerged as a promising transcatheter technology in preventing restenosis for diseased arteries. The principal investigator of FUTURE SFA is Edward Choke (Sengkang General Hospital, Singapore), who comments: “I am inspired by the bold, imaginative, and futuristic concepts presented by the Nanolute technology of the MagicTouch PTA sirolimus-coated balloon. In contrast to other contemporary technologies, MagicTouch PTA offers a solution which optimises both the deliverability and the absorption of sirolimus into the vessel wall.” He adds: “Initial experience with the XTOSI first in man study suggested that MagicTouch PTA can provide an effective way of revascularisation for PAD patients, by keeping the vessels open longer and reducing the need of repeated angioplasty procedures. I look forward to the FUTURE SFA randomised controlled trial, which will test whether the Magic Touch PTA sirolimus-coated balloon can improve the patencies of femoral and popliteal arteries in PAD patients. We hope to establish whether SCB will emerge as the new standard of care which will impact the way we treat PAD.” The trial will enrol 153 patients with Rutherford class 3 to 6 PAD. These subjects will be randomised in 2:1 fashion to receive either Magic Touch PTA or standard balloon angioplasty. Primary outcome will be primary patency at six months, defined as duplex peak systolic velocity ratio (PSVR) of 2.4 or less. Patients, care providers, investigators and outcome assessors, including vascular technologists performing the duplex ultrasound, will be blinded to the treatment allocations.
November 2020 | Issue 88
36 Market watch
Product News
Alto
Endologix launches Alto abdominal stent graft system in Europe
Endologix has announced the first implant of its Alto abdominal stent graft, commencing the European commercial release of the recently CE mark approved endograft. “We are pleased to expand the product launch to include Europe, making Alto available to our physician partners and patients there as well as in the USA,” commented Matt Thompson, chief medical officer of Endologix. “Alto offers a highly differentiated endovascular treatment option for AAA [abdominal aortic aneurysm] patients and includes design features that we believe will enhance ease-of-use, improve acute outcomes, and preserve the long-term durability associated with patient-specific anatomically adaptive sealing.” The first case was performed at East & North Hertfordshire Hospital in Stevenage, UK, by Matthew Metcalfe (consultant vascular surgeon) and Kate Steiner (consultant interventional radiologist). The Alto device was specifically chosen for this patient because he felt the patient’s short, thrombus-lined conical aortic neck could only be treated using Alto. “We are very excited to have access to the Alto device given its unique approach to excluding the aneurysm using a custom sealing technology, and the higher sealing ring enabled me to land and seal in healthy aortic tissue, which should give this patient a good long-term durable outcome,” Metcalfe said. “Building off previous product generations, there have been a whole host of feature enhancements which we have been anticipating, such as Alto’s 7mm neck requirement and 15F delivery system, which allow us to treat a diverse set of patient anatomies.” The commercial release of Alto in Europe will be supported by a worldclass team of sales representatives, clinical specialists and distributors, all focused on the collective objective of improving the health and lives of patients with aortic disorders through a steadfast commitment to delivering innovative and trusted endovascular aneurysm repair (EVAR) solutions.
Reflow Medical receives approval in Japan for the Wingman catheter
Reflow Medical has announced that Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has approved
the Wingman chronic total occlusion (CTO) catheter. Reflow Medical has partnered with Century Medical, a medical device distributor based in Tokyo, to introduce the Wingman CTO catheter in Japan. The Wingman catheter crosses peripheral CTOs using an extendable bevelled tip. The physician controls the advancement and activation of the tip to create a channel to help penetrate, or cross, the occlusion with a guidewire, enabling further treatment of the lesion with therapeutic devices. The catheter is compatible with the physician’s preferred guidewire and procedural technique. Approval by Japan’s PMDA follows the completion of the WingIT CTO clinical trial, a prospective, international, multicentre study that treated 85 patients and followed them for 30 days. The Wingman catheter was able to demonstrate a 90% crossing rate
Wingman
when up to two previous guidewires could not cross the CTOs, meeting its primary safety and efficacy endpoints. “Reflow Medical focuses their efforts on developing technologies based on physicians’ needs,” said John R Laird (Adventist Heart and Vascular Institute, St Helena, USA). Laird was the principal investigator for the study. “We rely on Reflow for real clinical evidence when utilising the technology.” Reflow’s Wingman crossing catheter received clearance from the US Food and Drug Administration for the expanded CTO indication for the Wingman crossing catheter in March 2020 after completing the Wing-IT clinical trial. QuickClear
Philips launches QuickClear mechanical thrombectomy system for blood clot removal in latest portfolio expansion
Royal Philips has announced the launch of the QuickClear mechanical thrombectomy system. The singleuse system delivers an all-in-one aspiration pump and catheter to remove blood clots from the vessels of the peripheral arterial and venous systems
and has received US Food and Drug Administration (FDA) 510(k) clearance. The system’s design aims to simplify the use of the device and improve procedure times without the need for capital equipment or accessories. Chris Landon, senior vice president and general manager of image guided therapy devices at Philips claims that “by taking away the high initial capital expenditure costs associated with traditional mechanical thrombectomy systems, QuickClear can help bring cost-effective solutions to both the hospital and outpatient care settings.” The small footprint of the sterile device allows it to be placed easily on the table next to the patient. The company claims that the system can easily work at maximum aspiration power within seconds and that the consistency of the aspiration power during the procedure supports faster procedure times. Furthermore, the system’s range of catheters includes a large 10F aspiration catheter which, according to the company’s own in-house data, provides 59% more aspiration volume than 8F aspiration catheters. Bryan Fisher (Nashville, USA) says that the “QuickClear is a simple and easy to use mechanical thrombectomy system.” He adds that it “is significantly smaller than other systems without compromising aspiration power. The QuickClear mechanical thrombectomy system is the latest expansion of the company’s portfolio after acquiring Intact Vascular. Philips’ peripheral vascular portfolio already includes advanced interventional imaging systems for precision guidance; intravascular ultrasound (IVUS) catheters to assess the location of the disease and lesion morphology and guide and confirm the treatment; peripheral atherectomy devices to remove blockages; and peripheral therapy devices, such as Philips’ Stellarex drug-coated balloon, to treat lesions.
Treo abdominal stent graft system launches commercially in the USA
Following approval this year by the US Food and Drug Administration (FDA) of the Treo abdominal aortic stentgraft system for the treatment of patients with abdominal aortic aneurysms (AAA), Terumo Aortic has announced the commercial launch of this endovascular device. One of the first procedures was undertaken by Matt Eagleton (Massachusetts General Hospital, Boston, USA). Eagleton comments: “The procedure was very successful, and the patient is recovering well. As the national principal investigator of the investigational device exemption (IDE) study, I was impressed with the performance of the Treo stent-graft system. Stent migration and endoleaks are major concerns in endovascular aortic repair (EVAR), and as the Treo device offers both suprarenal and
infrarenal fixation, distributing the stentgraft fixation in two different anatomical levels, this may work to reduce potential migration as evidenced in the pivotal study. Furthermore, the device design leads to clinically meaningful aneurysm sac shrinkage.” Treo received CE mark approval in 2015, and is integral to Terumo Aortic’s market-leading portfolio of surgical, endovascular, and hybrid devices to treat every segment of the aorta.
Gore enhances Viabahn endoprosthesis portfolio with lower profile delivery
Gore has announced the US launch of the lower profile, large diameter Gore Viabahn endoprosthesis. Gore previously received approval from the US Food and Drug Administration (FDA) for the enhanced Gore Viabahn endoprosthesis. “With broad clinical indications for use and numerous product improvements, the Viabahn device continues to be a dependable choice that demonstrates positive results in patients with complex vascular disease,” comments Amit J Dwivedi, (University of Louisville, Louisville, USA), who has implanted the lower profile device in complex arterial anatomy. “Older patients with co-morbidities such as hypertension, diabetes, and obesity may benefit from a less invasive endoluminal approach versus surgical bypass. These latest enhancements, including a lower profile, provide physicians with additional options for treating these patients.” According to a press release, this innovative Viabahn device design reduces the delivery profile for larger 9–13mm diameter stent grafts by up to 3Fr, enabling delivery through smaller sheaths. Smaller introducer sheaths have resulted in a lower risk of vascular access complications in select patient populations, a Gore press release states. Additionally, new radiopaque markers on the distal and proximal ends enhance visualisation under fluoroscopy, facilitating positioning and device delivery, as well as precise and predictable placement. “In addition to the radiopaque markers that facilitate positioning and deployment, the new lower profile enables use of a smaller sheath, potentially reducing the risk of damage at the access site,” says Yevgeniy (Eugene) Rits (Wayne State University; Detroit Medical Center; Harper University Hospital, Detroit, USA). “Combined with the trackability and flexibility I have always trusted with Viabahn devices, this new lower profile offering will become very instrumental in my dialysis access practice.” Currently, the Viabahn device is indicated for use in superficial femoral artery (SFA) lesions, iliac lesions, in-stent restenosis of SFA lesions, and in stenosis or thrombotic occlusion at the venous anastomosis of synthetic arteriovenous access grafts for haemodialysis.
Issue 88 | November 2020
Market watch 37 repeat procedures at 24 months.
Philips launches latest version of its Azurion imaging platform
Product News Biotronik’s Passeo-35 Xeo PTA balloon catheter is now available in Europe
Biotronik recently announced European market release of the Passeo-35 Xeo percutaneous transluminal angioplasty (PTA) balloon catheter. A company press release states that, compared to other available PTA balloons, the device offers physicians improved crossability, excellent trackability, and pushability in a wide range of sizes. “The new Passeo-35 Xeo balloon handled impressively well, crossing easily even in an occlusive lesion,” comments Gerd Grözinger (University Hospital Tübingen, Tübingen, Germany), after performing the firstin-human procedure with the balloon. “The deflation time was also very fast compared to other balloons, which can save valuable procedure time.” To aid in challenging lesion crossing, the Passeo-35 Xeo catheter offers a low entry profile, smooth tip taper, and up to 19.5% more pushability compared to competitors, facilitating improved catheter navigation in the peripheral vasculature. Catering to a full range of lesion sizes, the device is available in balloon diameters from 3–12mm and lengths of up to 250mm, with usable catheter lengths of 90, 130 and 170cm. Additionally, the Passeo-35 Xeo catheter is fully 5F compatible for balloon sizes up to 7mm in diameter and 250mm in length. The Passeo-35 Xeo balloon is indicated to dilate stenosis in the iliac, femoral, popliteal and infrapopliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. It is also recommended for post-dilatation of balloon-expandable and self-expanding stents in the peripheral vasculature. Passeo-35 Xeo is the platform for Biotronik’s recently released Dynetic-35 balloon-expandable cobalt chromium stent system.
CMS grants additional reimbursement for the Eluvia drug-eluting vascular stent system
Boston Scientific announced that the US Centers for Medicare and Medicaid Services (CMS) granted a new technology add-on payment (NTAP) for the Eluvia drug-eluting vascular stent system as part of the 2021 inpatient prospective payment system (IPPS). The NTAP designation, awarded to new medical devices determined to substantially improve the diagnosis or treatment of Medicare beneficiaries, will be effective on 1 October 1 2020 and will provide eligible hospitals with incremental reimbursement for the Eluvia stent system for up to three years. The Medicare criteria for an NTAP designation is based on newness of the
device, cost, and a substantial clinical improvement. The Eluvia stent system was developed for the treatment of peripheral arterial disease (PAD). The Eluvia stent reopens the blocked artery and restores blood flow, while also utilising a drug-polymer combination to offer a sustained, low-dose release of drug to prevent tissue regrowth within the stented artery. “The CMS determination is a very positive development for patients with PAD and supports what we have confirmed through our clinical trials— the Eluvia stent offers clinically superior outcomes compared to other peripheral drug-coated technology available to clinicians and their patients,” said Jeff Mirviss, executive vice president and president, Peripheral Interventions, Boston Scientific. “The decision is particularly important given the level of consideration and evaluation related to the role of paclitaxel in the peripheral vasculature, and we believe this designation reflects the unique attributes
Eluvia
of the Eluvia stent, which are clearly differentiated and improve the quality of life for the millions of people suffering from symptoms of PAD.” The NTAP designation will support access to the Eluvia stent for Medicare beneficiaries in the hospital inpatient setting, making it possible for eligible hospitals to receive NTAP payment in addition to the standard Medicare severity diagnosis related group (MSDRG) payment. The US Food and Drug Administration (FDA) approval of the Eluvia stent system in September 2018 was based on findings from the IMPERIAL trial, which exhibited the highest 24-month primary patency reported to date for the treatment of femoropopliteal disease in a US pivotal trial with a drug-coated balloon or drugeluting stent. Trial data confirmed a statistically significant lower clinicallydriven target lesion revascularisation (TLR) rate of 12.7% for patients treated with the Eluvia stent, in contrast to 20.1% observed within the Zilver PTX drug-eluting peripheral stent cohort (p=0.0495), thus reducing the need for
Royal Philips has announced the next-generation of its Azurion imageguided therapy platform, designed to improve the quality and efficiency of interventional procedures. The Azurion platform has been used in over two million procedures worldwide since its introduction three years ago, according to a company press release. In the past few decades, clinical practices around the world have evolved to successfully treat more patients and perform more complex procedures in interventional labs, the Philips press release noted, adding that with more staff and technologies involved during these procedures, interventional lab environments can become crowded and cluttered. In order to enhance clinician focus and control during procedures, Philips has integrated all the essential lab systems and tools into the new version of the Azurion platform. The Azurion image-guided therapy platform now integrates control of imaging, physiology, haemodynamic and informatics applications, as well as intuitive control of the gantry, at the tableside, allowing clinicians to control all compatible applications from a single touch screen while performing procedures. This can eliminate the need for clinicians to leave the sterile field and step into an adjacent control room, as well as supporting faster and better informed decision making, the company said. Philips is also introducing a new 3D imaging solution called SmartCT, where users are guided through image acquisition and can review and interact with the acquired CT-like 3D images on the tableside touch screen module using 3D visualisation and measurement tools. These tools have been designed to support procedures in a range of clinical domains, including neurology, oncology, and cardiovascular procedures. “Our aim as an innovation company and global market leader in imageguided therapy is to push the boundaries and set new industry standards for delivering an outstanding experience for clinicians, helping them to deliver superior care to every patient,” said Ronald Tabaksblat, general manager image guided therapy systems at Philips. “This next-generation Azurion makes routine cardiovascular procedures more efficient and supports the development of new minimally-invasive techniques to treat complex diseases such as stroke, lung cancer and spine disorders.” “The integrated platform enables us to efficiently carry out complex interventions at any time using a wide range of functions such as IVUS and iFR co-registration,” said Alexander Becker, head of the cardiac catheter laboratory at the Robert Bosch Hospital, Stuttgart, Germany, and one of the first hospitals to experience the new platform.
Azurion
“The use of the control panel by the examiner is intuitive, combining different sources of information to make patient evaluation much easier and faster.” Philips adds that the new Azurion platform allows clinicians to easily switch between imaging, physiology, haemodynamic and informatics applications, including SmartCT and IntraSight—a suite of clinically proven iFR, FFR, IVUS and co-registration modalities. The new Azurion also includes cybersecurity features, high-definition image display capabilities, and advanced remote and proactive services. The platform is available in three versions: complementing the Azurion 3 and 7 variants, Philips now also offers the Azurion 5 to facilitate tailored solutions to address specific customer needs.
Veryan Medical announces US launch and first commercial implant of BioMimics 3D vascular stent system
Veryan Medical recently announced the US launch and the first commercial implant in the USA of the BioMimics 3D vascular stent system. Nick Yeo, Veryan’s CEO commented: “Launching BioMimics 3D in the USA marks a significant landmark for Veryan. In preparation for this important commercial step, we have recruited a senior sales team, highly experienced in percutaneous vascular intervention, led by Joe DeJohn, Veryan’s US-based, chief commercial officer. I am confident that in building our commercial organisation on such strong networked foundations, supported by a major, real-world registry study that we expect to launch in USA next quarter, we will quickly establish BioMimics 3D as the go-to stent for femoropopliteal intervention in the USA.” On the same day that Veryan launched the device in the USA, Bret Wiechmann and his team at Vascular and Interventional Physicians in Gainesville, USA implanted the first commercial BioMimics 3D stent in the country. Wiechmann commented: “We are thrilled to have the opportunity to implant the first BioMimics 3D stent in the USA in anticipation of the full commercial launch. The three-dimensional, helical design is unique in this stent category and has demonstrated promising results, as evidenced by the recent release of the three-year follow up from the IDE [investigational device exemption] pivotal study.
November 2020 | Issue 88
38 Market watch
Industry News Bret Snyder named president and chief executive officer of W L Gore & Associates
W L Gore & Associates have announced that Bret Snyder, chair of the Gore board of directors, will succeed Jason Field in the role of president and CEO effective 9 October 2020. Jason will remain with the enterprise through December 2020 to support a smooth transition. “I have enjoyed my 16 years as a Gore Associate and am really proud of what we have accomplished together these last three years—in particular, increasing Associate engagement and growing sales and earnings, including through the pandemic challenge,” said president and CEO Jason Field. “Bret and I have worked closely together over the last few years, and I am confident Bret is uniquely positioned to lead Gore. He is especially close to the Gore values and culture that have made our Enterprise successful and are important to its continued success.” Bret brings 25 years of experience in research, innovation, and entrepreneurial growth to the role of president and CEO, with successes both inside and outside Gore. Since joining the
Enterprise in 2008, Bret has served in various technical and leadership roles throughout his career at Gore. Bret will continue to serve as the chair of the board, a position he has held since 2016. As the grandson of Gore’s founders Bill and Vieve Gore, Bret is the third generation of Gore family members to serve in the dual role of president and board chair. “I have the utmost respect for
Bret’s initial commitment upon joining Gore was in the Core Technology function, developing new materials for all the product divisions and working to expand Gore’s material science capabilities. He went on to join the PharmBIO business as a new product development engineer. Bret then served as technical leader for the portable electronics venting business, where he led through winning several large orders that significantly increased sales. Prior to joining Gore, Bret worked at Rohm and Haas, where he developed technology and served as a business and operations leader for the AgroFresh subsidiary. Bret holds a PhD in chemical engineering from University of Washington College of Engineering and a bachelor of science degree in chemical engineering from Brown University.
Mentice to acquire Vascular Simulations Jason’s leadership of Gore the last few years and have enjoyed working with him. He has embodied leading with integrity and has demonstrated a deeply personal commitment to the success of our Enterprise, our products and our Associates,” said Bret Snyder, chair of the board. “I am honoured to assume leadership of the Enterprise at this time and continue the positive momentum we have underway at Gore.”
Mentice recently signed a definitive agreement to acquire Vascular Simulations, a provider of replication solutions allowing endovascular procedures to be performed by doctors manipulating real medical devices within a physical 3D structure. This acquisition will expand Mentice’s global leadership role within endovascular simulation by offering value solutions that support all stages of a medical device’s development cycle
from initial concept to market-rollout to the safe adoption of a device, technique, and procedure by health systems worldwide. Mentice clients will now have the possibility to deploy and test real medical devices in a physical model under x-ray guidance, benefiting from a virtual high fidelity version of the same medical device and anatomy in a radiation-free environment. The integration and synchronisation of both the physical and digital space will provide an unparalleled realism that has unprecedented potential to improve clinical performance and patient outcomes. “The combined product portfolio will allow Mentice to offer simulation solutions into every stage of a medical device’s development cycle helping improve speed to market, device adoption, and volume targets ultimately driving better patient outcomes,” said David Fiorella, director of the Stony Brook Cerebrovascular Center and co-director of the Stony Brook Cerebrovascular and Comprehensive Stroke Center, professor of Neurosurgery and Radiology. “We are excited about this fusion of talents and solutions and are certain this acquisition has the potential to change the market perspective on skill acquisition and proficiency retention,” Fiorella continued.
Calendar of events Please be advised that the events listed opposite, because of COVID-19, are subject to change. Please check the relevant website for further details as the event may be cancelled, postponed, or become a virtual event.
6–8 November VIVA: Vascular Interventional Advances Virtual
7–9 March 24th European Vascular Course (EVC) Maastricht, the Netherlands
21–23 October Paris Vascular Insights Paris, France
24–27 November UK Vascular Societies’ Annual Scientific Meeting Virtual
19–22 April CX 2021 Vascular and Endovascular Controversies Digital Edition Virtual
16–20 November VEITHsymposium New York, USA
2021 26–29 January LINC – The Leipzig Interventional Course Leipzig, Germany
2–5 June Society for Vascular Surgery (SVS) Vascular Annual Meeting San Diego, USA
www.vivaphysicians.org
www.vascularsociety.org.uk
www.leipzig-interventional-course.com
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Limbof Chronic work Management es on the years of collaborative s and r Guidelin surgeon of four of having Global Vascula the product chronic limb- r The goal tion of the year sees the world. for patients with for Vascula The publica Ischaemia this ys s around the Society publication. The Threateningr experts and societie treatment pathwacement from r es’ of Vascula the guidelin by vasculato agree on the optimal ed in an announ fruition in European Journal describ come to the providers ischaemia was (JVS). journals: which has r Surgery societies’ threatening a “quixotic quest”, two of the the Journal of Vascula as Surgery was published in and (EJVES) document scular Surgery and Endova evaluation the definition, focuses on global patient he document ent of a large with mortality, and managem a disease associated particular and life. With population quality of practice, creating n, and impaired amputatio evidence-based as well as research, on guiding emphasis ks for treatment evidence or ed framewor standardis areas of low-levelperception of the insight into the overall providing stages of severity. and changing for spectrum and unmet needs, include a wider Conte from the Society disease to were Michael from the European from Co-editors Philippe Kohl Andrew Bradbury Surgery, and Vascular Nearly 60 Vascular Surgery Societies. ts Society for of Vascular Participan Federation that on the project. the World authors worked represented all specialties additional and . continents n of spanned six tening ischaemia limb-threa to the publicatio treat chronic Vascular News prior Vascular Guidelines to Speaking “the Global for Vascular , Conte said and the guidelines effort from the Society Vascular Surgery all are a combined Society for who have European Societies, Surgery, the of Vascular the past.” In the effort Federation in the World nt guidelines guidelines, Conte independe ive joint produced that we set of collaborat important project we are to create a and most —which first very limb ischaemia said, “the .” was advanced tening ischaemia undertook chronic limb-threa now calling is in a name? used definition to CLTI: What From CLIterminology from the widely limb(CLI) to chronic of a key shift The shift in limb ischaemia indication is of critical patient (CLTI) this g ischaemia g and treating threatenin around lising, identifyin the terminology in conceptua changed . “We have population
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2019 | Issue
83
en: Alan Lumsd
Profile
Page 26
Page 29
nted” “Unprecede t developmen ic of NICE aort guideline aneurysm
Institute N of the National guideline VERSIO THE DRAFT Care Excellence (NICE) on in and for consultati for Health when released that patients with ndation created a furore, be offered its recomme should only 2018, with d aneurysm able to undergo an unrupture if they were fit and providers open surgery, . Many surgeons, service guideline draft the procedure ers have called the n has been and stakehold and its publicatio “unimplementable” since then. Board,” deferred the NICE repeatedly of the now sits with UK), president “The guideline (London, and Ireland Loftus Ian Britain says for Great nted. “There Vascular Societycalls this step unprecede re-wording who sides and (VSGBI), ise on both ,” he tells Vascular the must be comprom workable guidance closely with to make this that NICE is working . News, noting progress the guideline onal Interventi ers to Society of stakehold in discussion the British VSGBI and together been of (BSIR) have cated the concerns of Radiology and communi a letter to members with NICE g ty. In challengin communi has been set the vascular writes: “It is no date VSGBI, Loftus and at present there with NICE, for all concernedWe remain in touch help to find a n. to our for publicatio reiterated our desire Conte interests of Michael about the fact that [...] and have is in the best “to recognise solution that did raise our concerns and tening workable Conte said, limb-threa NICE The He adds: “We constitutes this problem,” s, with both scenarios. patients.” practice, what of the guideline in different it.” in current suggests that to change the wording may be different limb ischaemia were unable ischaemia below which of critical BSIR, but is okay. value of perfusion previous concept everyone threshold which there is some and above the expanding is critical, 4 diabetes and on page everyone is that with Continued What we realised
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