Vascular News 100 – November 2023 US Edition by BIBA Publishing

November 2023 / Issue 100

www.vascularnews.com

100 Featured in this issue:

12 New guidelines

Management of PAD in patients with diabetes addressed

16 Profile

Peter Schneider

th EDITION

25 Claire Dawkins

Adapting to life as a new consultant

OBITUARY

Roger M Greenhalgh 6th February 1941 – 6th October 2023 Roger Malcolm Greenhalgh, the surgeon internationally renowned for his unparalleled contribution to vascular education, training and research, died peacefully on 6th October, aged 82. At the time of his death, he was emeritus Professor of Surgery at Imperial College in London and head of its Vascular Surgery Research Group.

reenhalgh, born in Derbyshire, was not from a medical background. His parents were very entrepreneurial in their different ways and his grandfather, Fred Poynton, broke the world record in road walking over 20 miles in 1924. He went to Ilkeston Grammar School, a state school with entry by scholarship only. There he followed the advice of his headmaster, John Hewitson, that he should consider medicine as a career. He was the first in his family to attend university. Within a term of arriving at Clare College, Cambridge, his medical tutor, Dr Gordon Wright, predicted that Greenhalgh would be a surgeon. At St Thomas’s Hospital in London, he qualified as a doctor and was allowed to move up the surgical ladder with a rotation to learn research methods at the Hammersmith Hospital after his surgical training at St Thomas’s. During this time, he discovered a love of vascular surgery. The pioneer vascular surgeon, Peter Martin, inspired him by saying that he would go on to solve problems that he could not. Whilst in training, in 1974, he won the prestigious Moynihan Fellowship of the Association of Surgeons of Great Britain & Ireland. The £1,000 stipend enabled him to visit many worldwide vascular centres of excellence using the connections of his mentors Peter Martin, Frank Cockett and Professor Gerry Taylor. Greenhalgh joined the surgical consultant staff as senior lecturer at Charing Cross Hospital in 1976, less than 10 years after being a medical student. His career did not follow a conventional path by moving from the St Thomas’s system to St Bart’s and finally, to Charing Cross. He went on to become professor of surgery, head of the university department and dean of the Charing Cross & Westminster Medical School for four years, between 1993 and 1997, during which time he oversaw a merger with Imperial College London. His junior at St Bart’s and then Secretary of the Vascular Society of Great Britain and Ireland (VSGBI), Professor Bruce Campbell, said to Professor Greenhalgh, who was the millennium president of the Vascular Society from 1999 to 2000: “You always do your own thing, you know you do.” Greenhalgh’s long and distinguished research career started with an interest in hyperlipidaemia

when he was a resident, during which he attempted to elucidate the role played by serum lipids and lipoproteins in arterial disease as lead author of a 1971 paper published in The Lancet. His research, with more than 300 original published papers, spanned all areas of vascular surgery: venous, carotid, peripheral and aortic. His most significant contributions came from his early adoption of the rigour of prospective randomised trials to address the grey areas in vascular disease management. He led more than a dozen trials in the field of aneurysm management to promote level-one evidence in clinical practice, including the UK Small Aneurysms Trial (UKSAT) and the UK endovascular aneurysm repair (EVAR 1 and 2) trials. UKSAT was the first trial to show that there was no long-term survival benefit of early elective open repair of small abdominal aortic aneurysms. The 15-year follow up of the EVAR 1 and 2 trials were published in The Lancet in 2016 showing EVAR has an early survival benefit but an inferior late survival compared with open repair, but needs to be addressed by lifelong

He leads by example. Not only by his contributions, or his political influence, or his knowledge, or trials, but actually as a person.”— Enrico Ascher in 2018

surveillance of EVAR and reintervention if necessary. Greenhalgh was also the principal investigator of the mild to moderate intermittent claudication (MIMIC) trials which finally proved the adjuvant benefit of angioplasty over supervised exercise and best medical therapy in patients with stable mild and moderate intermittent claudication. Inspired by the impact of these many landmark trials, Andrew W Bradbury, Sampson Gamgee Professor of Vascular Surgery, University of

Birmingham, Birmingham, UK, and principal investigator of the randomised controlled BASIL trials, wrote to Professor Greenhalgh: “Your achievements are greater than anyone alive or dead.” Professor Bradbury recently presented first-time results from the BASIL-2 trial at CX 2023 during a session chaired by Greenhalgh. Greenhalgh founded the Charing Cross (CX) series of international symposia and annual books in 1978 when he was 37 years of age. This started as a small, focused symposium, with topics such as smoking and arterial disease, held at the Charing Cross Hospital. The earliest symposia had just 100–200 delegates but were always accompanied by a book covering the main presentations and discussions. The CX Symposium has grown exponentially and has been forced to move to much bigger venues to cope with the increasing popularity of the meeting which peaked at over 4,000 in-person attendees in the years immediately before the COVID-19 pandemic. Pioneers such as Michael DeBakey, Denton Cooley, Jesse Thompson, John Mannick, John Bergan, Jimmy Yao, Ted Diethrich, Juan Parodi and Frank Veith have all graced the podium. Tom Fogarty spoke of his catheter and Andreas Grüntzig spoke of his angioplasty in the 1980s. Julio Palmaz gave news of endovascular aneurysm repair (EVAR) at CX 1990. CX continues to provide top class vascular education and critical discussion of cutting-edge developments in the management of vascular disease. Professor Greenhalgh presided over the 45th symposium earlier this year. Many speakers feared his acerbic wit and the tolling of the bell if they strayed overtime. Professor Greenhalgh, who was quick to embrace digital methods of transmission, recently spoke from the state-of-the-art CX Vascular studio in London to detail the global interest in the CX brand of education. In 2023, the symposium saw registrations from 2,500 in-person attendees and an additional 7,000 people participated digitally, tuning in mainly from China. He was always in his element at the CX podium, his secret passion for the theatre on full display, enjoying Continued on page 4

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94.7% 64.1%

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Verhagen, et al. The ENGAGE Registry: Ten-Year Outcomes with the Endurant Stent Graft for Endovascular Abdominal Aortic Aneurysm Repair. Presented at: Charing Cross 2023 International Symposium; April 26, 2023; London, UK.

Indications The Endurant™ II/Endurant™ IIs bifurcated stent grafts are indicated for the endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms. They may be utilized in conjunction with the Heli-FX™ EndoAnchor™ system when augmented radial fixation and/or sealing is required; in particular, in the treatment of abdominal aortic aneurysms with short (≥ 4 mm and < 10 mm) infrarenal necks (see Neck length definition below). The Endurant II stent graft system aorto-uni-iliac (AUI) stent graft is indicated for the endovascular treatment of infrarenal abdominal aorticor aortoiliac aneurysms in patients whose anatomy does not allow the use of a bifurcated stent graft. The Endurant II/IIs stent graft system is indicated for use in patients with the following characteristics: • Adequate iliac or femoral access that is compatible with vascular access techniques, devices, or accessories • Proximal neck length of • ≥ 10 mm; or • ≥ 4 mm and < 10 mm when used in conjunction with the Heli-FX EndoAnchor system (bifurcated stent graft only) Note: Neck length is defined as the length over which the aortic diameter remains within 10% of the infrarenal diameter. • Infrarenal neck angulation of ≤ 60° • Aortic neck diameters with a range of 19 to 32 mm • Distal fixation length(s) of ≥ 15 mm • Iliac diameters with a range of 8 to 25 mm

• Morphology suitable for aneurysm repair

Contraindications The Endurant II/Endurant IIs stent graft system is contraindicated in: • patients who have a condition that threatens to infect the graft • patients with known sensitivities or allergies to the device materials When used with the Heli-FX EndoAnchor system, the Endurant II/IIs stent graft system is also contraindicated in: • patients with known sensitivities to the EndoAnchor implant materials. For contraindications regarding ancillary devices used with the Endurant II/Endurant IIs stent graft system, refer to the Instructions for Use provided with the device. Warnings and Precautions • The long-term safety and effectiveness of the Endurant II/Endurant IIs stent graft system has not been established. All patients should be advised that endovascular treatment requires lifelong, regular follow-up to assess the health and the performance of the implanted endovascular stent graft. Patients with specific clinical findings (e.g., endoleaks, enlarging aneurysms, changes in the structure or position of the endovascular graft), or less than the recommended number of EndoAnchor implants when used in short proximal necks (≥ 4 mm and < 10 mm), should receive enhanced follow-up. Specific follow-up guidelines are described in the Instructions for Use. • Patients experiencing reduced blood flow through the graft limb, aneurysm expansion, and persistent endoleaks may be required to undergo secondary interventions or surgical procedures. • The Endurant II/Endurant IIs stent graft system is not recommended in patients unable to undergo or who will not be compliant with the necessary preoperative and postoperative imaging and implantation procedures as described in the Instructions for Use. • Renal complications may occur: 1) From an excess use of contrast agents. 2) As a result of emboli or a misplaced stent graft. The radiopaque marker along the edge of the stent graft should be aligned immediately below the lower-most renal arterial origin.

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• Studies indicate that the danger of micro-embolization increases with increased procedure

duration. • The safety and effectiveness of the Endurant II/Endurant IIs stent graft system has not been evaluated in some patient populations. Please refer to the product Instructions for Use for details. MRI Safety and Compatibility: Non-clinical testing has demonstrated that the Endurant II/ Endurant IIs stent graft is MR Conditional. It can be scanned safely in both 1.5T & 3.0T MR systems under certain conditions as described in the product Instructions for Use. For additional MRI safety information, please refer to the product Instructions for Use.

Adverse Events Potential adverse events include (arranged in alphabetical order): amputation; anesthetic complications and subsequent attendant problems (e.g., aspiration), aneurysm enlargement; aneurysm rupture and death; aortic damage, including perforation, dissection, bleeding, rupture and death; arterial or venous thrombosis and/or pseudoaneurysm; arteriovenous fistula; bleeding, hematoma or coagulopathy; bowel complications (e.g., ileus, transient ischemia, infarction, necrosis); cardiac complications and subsequent attendant problems (e.g., arrhythmia, myocardial infarction, congestive heart failure, hypotension, hypertension); claudication (e.g., buttock, lower limb); death; edema; EndoAnchor system (for infrarenal EVAR procedures using the Heli-FX EndoAnchor system): partial deployment, inaccurate deployment, fracture, dislodgement, embolization, stent graft damage, modelling balloon damage); embolization (micro and macro) with transient or permanent ischemia or infarction; endoleak; fever and localized inflammation; genitourinary complications and subsequent attendant problems (e.g., ischemia, erosion, femoral-femoral artery thrombosis, fistula, incontinence, hematuria, infection); hepatic failure; impotence; infection of the aneurysm, device access site, including abscess formation, transient fever and pain; lymphatic complications and subsequent attendant problems (e.g., lymph fistula); neurologic local or systemic complications and subsequent attendant problems (e.g., confusion, stroke, transient ischemic attack, paraplegia, paraparesis, paralysis); occlusion of device or native

vessel; pulmonary complications and subsequent attendant problems; renal complications and subsequent attendant problems (e.g., artery occlusion, contrast toxicity, insufficiency, failure); stent graft: improper component placement; incomplete component deployment; component migration; suture break; occlusion; infection; stent fracture; graft twisting and/or kinking; insertion and removal difficulties; graft material wear; dilatation; erosion; puncture and perigraft flow; surgical conversion to open repair; vascular access site complications, including infection, pain, hematoma, pseudoaneurysm, arteriovenous fistula, dissection; vascular spasm or vascular trauma (e.g., iliofemoral vessel dissection, bleeding, rupture, death); vessel damage; wound complications and subsequent attendant problems (e.g., dehiscence, infection, hematoma, seroma, cellulitis) Please reference product Instructions for Use for more information regarding indications, warnings, precautions, contraindications, and adverse events. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

November 2023 | Issue 100

Obituary

OBITUARY

Roger M Greenhalgh 6th February 1941 – 6th October 2023 Continued from page 1

the cut and thrust of discussing the current, hotbutton issues in the vascular field with global experts. Age did not wither nor custom stale his delight in unpicking an argument to get to the core of the matter, always endeavouring to outline the research and education required to drive the topic forward. In the days before his passing, Professor Greenhalgh’s passion for the quality of the CX Symposium programme burned brightly right to the very end as he worked on the CX 2024 version in the Hammersmith Hospital’s De Wardener ward intensive care unit. Professor Greenhalgh played a pivotal role in the creation of the European Society for Vascular Surgery (ESVS) and the establishment of its journal. The ESVS was launched at CX in 1987 and Professor Greenhalgh wrote the constitution. He was founder and chairman of the editorial board for the European Journal of Vascular and Endovascular Surgery (EJVES) from 1987 to 2003. He became the first ESVS European honorary member because of his role in the ESVS foundation. He also played a major role in the development of surgical training and standards across Europe through his role as President of the European Board of Surgery for the European Union of Medical Specialists (Union Européenne des Médecins Spécialistes – UEMS) from 1998 to 2002 and the European Board of Vascular Surgery (2002-2006). The European Board of Vascular Surgery honoured Professor Greenhalgh as Honorary Life President in recognition of his founding role. His brilliant surgical skills were recognised by innumerable international surgical societies as well as the White House Medical Unit for the support he provided during the visit of President George HW

Bush to London in 1991. More recently, Professor Greenhalgh became a company director, founding BIBA Medical with his son, Stephen, in 1994. Professor Greenhalgh was editor-in-chief of the company’s foremost medical publication, Vascular News, from its inception in 1999 to 2023, overseeing a total of 100 editions of the newspaper in this time. He captured his experiences in the roles of surgeon, professor and company director in his 2011 autobiography, Born to be a Surgeon. Professor Greenhalgh received recognition for his lifelong contributions to vascular surgery from multiple prestigious groups, including most recently, an honorary Fellowship of the American College of Surgeons in October 2018 and the first Living Legend or International Lifetime Achievement Award from the Society for Vascular Surgery (SVS) in June 2018 after being nominated by the ESVS. Enrico Ascher (New York University, New York, USA), who presented the award and is a past president of the SVS, said of Professor Greenhalgh at the time: “He leads by example. Not only by his contributions, or his political influence, or his knowledge, or trials, but actually as a person. As a person who is totally committed to his profession, to his family, to his friends, to his peers. He thinks first about them, and not about himself. That is what makes him a moral leader, and what sets him apart.” Writing in EJVES following Professor Greenhalgh’s receipt of this award, his long-time research partner, Professor Janet Powell (Imperial College, London, UK) described him as a “brilliant” clinician with a “long and distinguished” research career, as well as highlighting his prowess as an educator and mentor, noting that “medical students and junior doctors have queued for the opportunity to work in his team”. She also hailed him as a “legendary figure” whose wit, humour and charm “have made him many friends across the world”. Professor Greenhalgh had many sporting skills and interests. He rowed in international regattas with future Olympian, Peter Thomas, at stroke whilst he was captain of boats as a medical student at St Thomas’s Medical School. He remained a strong

Medical students and junior doctors have queued for the opportunity to work in his team.”— Janet Powell in 2018

supporter of the Imperial College Boat Club and even had a boat named after him. His love of skiing saw him create the Association of International Vascular Surgeons (AIVS) which was used to forge international professional friendships and the AIVS continues to this day under the chairmanship of Mark A Adelman. He was supported throughout by his Austrian wife, Karin, whose ability to speak multiple European languages and communicate with people from all cultures, proved invaluable. Professor Roger Greenhalgh, MA MD MChir

KEY DATES:

1971: Greenhalgh is lead

Lifetime achievements: Through the years Professor Greenhalgh was involved in vascular education, training and research from the early 1970s to 2023

author of a paper on the role played by serum lipids and lipoproteins in arterial disease published in The Lancet

1978: G reenhalgh

founds the Charing Cross (CX) series of international symposia and annual books

1980s: T om Fogarty

speaks of his catheter and Andreas Grüntzig of his angioplasties at CX

1987: E uropean

Society for Vascular Surgery (ESVS) launches at CX

Issue 100 | November 2023

Obituary

THOUGHTS FROM THE VASCULAR WORLD “Your achievements are greater than anyone alive or dead.”

1. Roger Greenhalgh operating 2. Princess Anne attends the CX Symposium in 1982 3. Michael DeBakey (far left), Karin Greenhalgh and Roger Greenhalgh in 1989 4. White House Certificate of Appreciation awarded to Roger Greenhalgh in 1991 5. Roger Greenhalgh receiving the first Living Legend or International Lifetime Achievement Award from the Society for Vascular Surgery (SVS) in 2018 from Enrico Ascher

FRCS, was married to Karin Maria (née Gross)—who died in April 2020 4 from COVID-19. They were happily married for over 55 years and her constant support was integral to his success. He was at his most relaxed amongst his family. He is survived by his two children, Stephen (Lord Greenhalgh) and Christina, and three grandchildren Sebastian, Francesca and Marcus of whom he was immensely proud.

Share you messages, stories and photos

The Professor Roger M Greenhalgh book of condolence can be found here: https:// tinyurl.com/2ubsymf9. Please post your messages, stories and photos to commemorate his life and legacy.

1990: J ulio Palmaz

gives news of EVAR at CX

ANDREW BRADBURY

“We have lost a pioneer, an inspiration, a mentor and an icon of vasular surgery.” ANDREW HOLDEN

“A great legacy for the vascular community.” DITTMAR BÖCKLER

1995: U K Small

Aneurysm Trial (UKSAT)

2016: F ifteen-year follow-

2004: E ndovascular

up of the EVAR 1 presented at CX and published in The Lancet

aneurysm repair (EVAR) trials begin

2008: M IMIC trials 2017: F ifteen-year

followup of the EVAR 2 trial presented at CX

BIBAMedical 1994: G reenhalgh

founds BIBA Medical with his son Stephen

1999: First issue

of Vascular News is published

2011: T he biography

Born to be a surgeon goes on sale

November 2023 | Issue 100

CX Legacy Continues

THE LEGACY

Forty fiveyear legacy of CX vascular education continues Three newly appointed Charing Cross International Symposium (CX) co-chairs will ensure Roger Greenhalgh’s inspiring legacy of vascular education continues at CX 2024 with the 46th CX Symposium (23–25 April, London, UK). Dittmar Böckler (Heidelberg, Germany), Andrew Holden (Auckland, New Zealand) and Erin Murphy (Charlotte, USA) speak about CX founder Roger Greenhalgh’s lasting legacy and the honour of leading future CX Symposia in his wake. Professor Greenhalgh personally nominated the CX co-chairs to carry the CX baton and honour the style of education he had established.

■ Statement from Dittmar Böckler (Heidelberg, Germany)

“In 1998, I started my career in vascular surgery, more or less by chance. In 2000, as a young fellow, I was able to attend the Charing Cross Symposium, where I saw and experienced Professor Greenhalgh for the first time; his charisma, his aura, his passion, his foresight and his vision have left a lasting impression on my professional life. Over the past two decades, Professor Greenhalgh has become my role model in academic vascular surgery and medical education. Professor Greenhalgh is a pioneer and a giant in vascular surgery and medicine. It has been a privilege and honour to share his friendship over all these years. I will never forget his strong personal relationship with the German Society of Vascular Surgery (DGG) and his attendance at several of our Society’s annual meetings, together with his son Stephen. My thoughts are with the family, but also with Professor Greenhalgh, who has had an extraordinary influence on my life as a vascular surgeon. It is an honour and a privilege to carry on his legacy and vision with colleagues, friends of Roger and his son Stephen. I will never forget his credo: ‘…to discover and promote new talents and bring medical

education and CX to the next level, year by year! It is all about controversies and especially consensus in academic medicine, but also in life…’ Roger, thank you so much for what you have done for vascular surgery, for me in person, and for what you’re passing on to us—a great legacy for the global vascular community!”

■ Statement from Andrew Holden (Auckland, New Zealand)

“With the passing of Professor Roger Greenhalgh, we have lost a pioneer, an inspiration, a mentor and an icon of Vascular Surgery. Roger’s passion for education, evidence-based and patient-focused care as well as the value of an inclusive, multidisciplinary approach has greatly influenced many of our careers. Roger embraced innovation and encouraged debate but was quick to challenge ideas not backed with scientific rigour, often in an amusing but direct way! Although Roger battled physical health challenges in recent years, his intellectual capacity and inquisitive nature remained remarkable right to the end. Roger leaves a great legacy and we are humbled by the opportunity to continue this legacy in some small way.”

■ Statement from Erin Murphy (Charlotte, USA)

“Professor Greenhalgh will forever be cherished as a legendary surgeon of immense stature. He was a visionary, thriving on challenges and relentlessly pushing for progress. He once shared with me that he took immense joy in the process of creating something out of nothing, and indeed, he embodied the spirit of a true builder. Throughout his lifetime, he not only crafted an extraordinary life and career that commanded respect, but he also embraced moments to generously share his knowledge and inspire others. Working alongside Roger was an opportunity to witness gracious leadership, which was both a rewarding and humbling experience. I will deeply miss our chances to converse and collaborate. I am [honoured] to have been a part of his journey. His legacy will endure through the knowledge he imparted and the educational framework he established which will continue to enrich global education for years to come.”

News in brief

The latest stories from the vascular world

n CAROTID STENTING: The Centers for Medicare & Medicaid Services (CMS) has released its final decision regarding National Coverage Determination (NCD) 20.7 covering carotid artery stenting (CAS), essentially confirming the coverage expansion outlined in a July proposed decision memo.

For more on this story go to page 10. n THORACIC AORTIC GUIDELINES: Kevin Mani (Uppsala University, Uppsala, Sweden) writes that a forthcoming guidelines document on descending thoracic aortic (DTA) disesaes “does not shy away” from providing solid recommendations despite there being limited Level A evidence available. He advises that the updated guidelines, for which he is a member of the writing committee, will be released in 2024.

For more on this story go to page 18. n AAA SAC MANAGEMENT: Smart polymer treatment of abdominal aortic aneurysm (AAA) sacs during endovascular aneurysm repair (EVAR) is the focus of a new advertorial from Shape Memory Medical. “Smart polymer device treatment of the flow lumen outside of an endograft during elective EVAR is an exciting prospect,” the company tells Vascular News. Initial studies have been carried out, and the company is now on the path toward the “gold standard” in clinical evidence— a randomised controlled trial.

For more on this story go to page 21.

Editor-in-chief: Roger Greenhalgh | Publisher: Stephen Greenhalgh | Content Director: Urmila Kerslake | Head of Global News: Sean Langer Editor: Jocelyn Hudson Jocelyn@bibamedical.com | Editorial contribution: Jamie Bell, Will Date, Bryan Kay and Éva Malpass Design: Terry Hawes, Wes Mitchell and David Reekie Advertising: Rav Pankhania Rav@bibamedical.com Subscriptions: subscriptions@bibamedical.com Published by: BIBA News, which is a subsidiary of BIBA Medical Ltd | BIBA Medical, Europe, 526 Fulham Road, Fulham, London, SW6 5NR, United Kingdom Tel: +44 (0) 20 7736 8788 BIBA Medical, North America, 155 North Wacker Drive, Suite 4250, Chicago, IL 60606, United States Tel: +1 708-770-7323 Printed by: Buxton Press Reprint requests and all correspondence regarding the newspaper should be addressed to the editor at the United Kingdom address. © BIBA Medical Ltd, 2023. All rights reserved.

If you have comments on this issue or suggestions for upcoming editions write to jocelyn@bibamedical.com VascularNews

linkedin.com/company/Vascular-news

@VascularNews

100

CMY

CONTROVERSIES

CHALLENGES

CONSENSUS

Vascular & Endovascular

Controversies Update

LONDON, UNITED KINGDOM

Aortic Controversies

Peripheral Arterial Controversies

Venous & Lymphatic Controversies

Acute Stroke Controversies

Vascular Access Controversies

The Hurting Leg Controversies

Vascular Trauma Controversies

CMY

CXSYMPOSIUM.COM

45 YEAR LEGACY OF VASCULAR EDUCATION CONTINUES CX CO-CHAIRS

ANDREW HOLDEN

DITTMAR BÖCKLER

ERIN MURPHY

EDUCATION

INNOVATION

EVIDENCE

November 2023 | Issue 100

Latest News 15

PERIPHERAL

MVSS 2023: Human Acellular Vessel proves “safe, effective bypass conduit” in complex CLTI cohort An investigator-sponsored clinical study conducted at the Mayo Clinic in Rochester, USA, of the investigational Human Acellular Vessel (HAV) in patients with chronic limb-threatening ischemia (CLTI) was presented at the Midwestern Vascular Surgical Society (MVSS) annual meeting (7–9 September, Minneapolis, USA).

elivered by Sebastian Cifuentes, from the Department of Vascular and Endovascular Surgery at the Mayo Clinic, the researchers concluded that in the clinical study the HAV was a safe, resilient, and effective conduit for arterial bypass and limb salvage. The presentation reported the outcomes of 29 patients—with a mean age of 71 who had no available vein to use as a bypass graft—who underwent HAV implantation. Of these patients, 97% had previously experienced unsuccessful revascularisation procedures on the extremity and 21 (72%) had tissue loss or gangrene. Based on the state of this disease, this patient group had a 30–50% one-year risk of amputation. Notably, surgery in 22 (76%) patients necessitated a tibial artery target, a surgical procedure involving the fusion of two 42cm long HAVs to achieve the required bypass length. The Mayo team, led by Todd Rasmussen, MD, reported that the operations to implant the HAV achieved a 100% technical success rate, without any HAV-related major adverse events reported. At a median follow-up of nine months, the secondary patency rate for patients implanted with the HAV was 72%. The limb salvage rate

was 86%, corresponding to only a 14% amputation rate. “In a complex cohort of patients with CLTI and no autologous options, the HAV is a safe and effective arterial bypass conduit,” Cifuentes reported at MVSS 2023. “This experience using the US Food and Drug Administration (FDA) Expanded Access Program provides real-world data that can inform regulatory deliberations and future trials of the HAV. Further studies will evaluate the HAV as a first-line

bypass conduit to define patency and limb-salvage potential in less severe cases of CLTI.” The HAV, a bioengineered tissue, is under investigation as an infection-resistant alternative for revascularization. Designed to be ready off-the-shelf, the HAV has the potential to save valuable time for surgeons and to reduce discomfort and complications for patients. The HAV has accumulated more than 1,000 patient-years of experience worldwide in a series of clinical trials in multiple indications, including vascular trauma repair, arteriovenous access for hemodialysis, and PAD, Humacyte, the company behind the product, reports. The HAV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency. Meanwhile, Humacyte also recently announced positive top line results from its V005 Phase 2/3 trial of the Human Acellular Vessel (HAV) in vascular trauma repair. A company press release reported that the single-arm clinical trial was a success and showed that the HAV in this study had higher rates of patency, and lower rates of amputation

Human Acellular Vessel

US FDA approves LimFlow system for treatment of CLTI The US Food and Drug Administration (FDA) recently announced approval of LimFlow therapy—a novel and minimally invasive procedure designed to bypass blockages in arteries of the legs and restore blood flow for many thousands of people suffering from chronic limbthreatening ischemia (CLTI). LIMFLOW’S FDA APPROVAL FOLLOWS New England Journal of Medicine publication of results from the PROMISE II multicentre prospective study, co-led by University Hospitals (UH) Harrington Heart & Vascular Institute (Cleveland, USA), which found that the therapy enabled most patients treated to keep their leg and experience wound healing. Mehdi Shishehbor, president of UH Harrington Heart & Vascular Institute, and Angela and James

Sebastian Cifuentes

and infection, compared to historic synthetic graft benchmarks. Humacyte plans to file a Biologics License Application (BLA) for the treatment of vascular trauma with the FDA during the fourth quarter of 2023. The V005 trial was a single-arm study conducted in the USA and Israel in patients with arterial injuries resulting from gunshots, workplace injuries, car accidents, or other traumatic events. Patients enrolled in the study did not have the standard of care, saphenous vein, available to use as a bypass graft. As a result, had the patients not received the HAV, they likely would have been treated with synthetic grafts, ligation of the bleeding artery, and/or amputation.

Further studies will evaluate the HAV as a first-line bypass conduit to define patency and limb-salvage potential in less severe cases of CLTI.”

Hambrick chair in Innovation, as well as lead author and co-principal investigator of the study, said: “LimFlow is a unique alternative to major amputation, providing hope to hopeless cases. The results from this study are excellent, and expanding LimFlow’s availability beyond the hospitals participating in the clinical study has the potential to save many more limbs and lives.” A press release details that LimFlow takes a new approach to treating patients who are facing major amputation because they have no other suitable treatment options, such as traditional bypass surgery or endovascular revascularisation, due to extensive disease in the target arteries or other anatomical constraints. Using proprietary devices, the procedure essentially turns a vein into an artery. This shift rushes blood back into the foot. The PROMISE II study evaluated 105 CLTI patients who were treated with transcatheter arterialisation of the deep veins (TADV) using LimFlow therapy. All patients had non-healing wounds on their feet and were facing inevitable amputation before the procedure. At six months post-procedure, the rate of limb salvage was 76%. Within the same time period, 76% of patients had

completely healed or healing wounds. Freedom from all-cause mortality was 87% at six months. “Although vascular disease has existed for decades, research and innovations in treatment options have been lacking,” said Shishehbor. “At UH Harrington Heart & Vascular Institute, we are proud to have led the research that showed the FDA that LimFlow works, so that patients have another option to keep their leg and improve their quality of life.” Vein becoming artery with LimFlow crossing stent

November 2023 | Issue 100

16 Interview

PROFILE

to do outpatient endovascular procedures with enough confidence and safety that we were able to send patients home to the other islands on the same day of the procedure. The thing of which I am the proudest is that between 1999 and 2011, we had a senior endovascular fellowship. This permitted trained vascular surgeons who had the content knowledge, the practice and the open experience to perform endovascular techniques with us for three months or more and then return to their respective practices. We trained 40 physicians in endovascular care.

PETER SCHNEIDER

Peter Schneider (University of California San Francisco, San Francisco, USA) speaks to Vascular News about his life and career. Trained during the era of open surgery only, Schneider saw the benefits of endovascular intervention early on, writing Endovascular Skills in the early 1990s and unlocking “one of the most fun aspects” of his career so far, with doctors from around the world sharing with him the importance of the book in their catheter experience. Considering the field of vascular surgery more widely, he opines that the “next wave” of advancement is imminent—pointing towards technologies that he believes will enable more personalised care of patients—and considers some of the major challenges that need to be addressed.

Why did you choose to specialise in vascular surgery?

Work on the vascular system caught my attention because of the unique combination of multifaceted, multiorgan system care in patients with little margin for error. Vascular surgery gives the opportunity to provide full spectrum care, to make long-term relationships, and to make a difference in the lives of the most vulnerable. The goals are practical, dilemmas are intellectually stimulating, the procedures are anatomically based, aesthetically pleasing, and technically challenging, and, there are numerous opportunities for innovation. My training was in the era of open surgery only. The potential that catheter-based techniques could be a natural complement to what we offer with open reconstruction really caught my attention and convinced me in the late 1980s that surgeons needed to be able to include endovascular work in daily practice.

Who were your career mentors and what was the best advice that they gave you?

So many important people contributed to my knowledge base and advancement, that I cannot name them all here. Nevertheless, there were several standouts from my time in San Francisco and my early career in Los Angeles. These include; Bill Krupski (take the time to mentor trainees), Linda Reilly (thinking through a challenging clinical scenario), Ron Stoney (complex open aortic work), George Andros (challenge the status quo when it is important), Jerry Goldstone (make connections across specialties and across the world), Doug Gray (cutting-edge work can be performed in a community hospital setting), Joe Rapp (patience), Leo Dulawa (have fun every day), and Bob Harris (best all-around technical surgeon with whom I have worked), and Eugene Bernstein (understand the complex well enough to make it simple).

What have been some of the most important developments in vascular surgery over the course of your career so far?

There has been substantial evolution in every aspect of the vascular care we offer over the past three decades. Improvements in medical management, the care of aneurysm disease, venous disease, arterial occlusive disease throughout the body, and the prevention of limb loss have occurred. I believe that we are on the precipice of the next major acceleration in advancements. The first was the ability to get patients with many comorbidities through

major open surgeries. The second was the ability to do complex reconstructions using endovascular means. I believe that the next wave of advancement is upon us and will include the broad use of biologic therapies, the incorporation of AI, introduction of genomics, and the use of sensors and digital health to further transform our field and to eventually result in personalised medical and surgical care for our vascular patients.

What are the biggest challenges currently facing vascular surgery?

1) One of the wonderful and collegial things about vascular surgery is about how small and personal it is and how one person can have an idea that will make a difference in practice. However, at the same time our small workforce is a major disadvantage, especially with the avalanche of vascular disease upon us resulting from the demographics of the present era. 2) The multi-organ system nature of vascular care also dictates that we must stay at the forefront of multiple processes affecting multiple organs and their corresponding medical disciplines. 3) Another major challenge is that the awareness and education in vascular disease, and advocacy for vascular patients has trailed other fields. Our small size, the relatively recent nature of advances in care in this area, and the fact that we care for patients who do not have a voice in the various socioeconomic systems in which we work contribute to this challenge.

How did the treatment offered to vascular patients at Kaiser Permanente change over the 24-year period you were there? When I arrived in Hawaii, the Kaiser system (a large hospital system in the USA) did not have a vascular programme. We established a multidisciplinary diabetic limb treatment programme which initiated in January of 1995 and was responsible for evaluating every diabetic within our catchment area who developed a foot lesion and resulted in a 50% decrease in amputation within a year. We started an accredited vascular diagnostic lab, registries for aneurysm and carotid disease, oversaw the installation of an endovascular operating room in 2003, established an endovascular aneurysm repair (EVAR) programme for ruptured abdominal aortic aneurysm (AAA), and a robust clinical research programme. We used Telehealth regularly and sent staff to other islands to see patients given the broad geography of the Hawaiian islands. When closure devices became approved in the early 2000s, we began

You have served as national principal investigator for numerous clinical trials. Which of these trials do you think has had the most significant impact on vascular surgery?

FACT FILE CURRENT AND PAST POSITIONS (SELECTED) 2018–present: Professor of surgery, Division of Vascular and Endovascular Surgery, University of California San Francisco (UCSF; San Francisco, USA) 1994–2018: Founding member and chief of the Division of Vascular and Endovascular Surgery, Kaiser Permanente (Honolulu, USA)

EDUCATION 1976–1978: Undergraduate, University of California San Diego (La Jolla, USA) 1978–1983: The Johns Hopkins University School of Medicine Five-Year BA-MD Curriculum, The Johns Hopkins University (Baltimore, USA)

RESIDENCIES 1983–1989: Resident in general surgery, UCSF 1989–1990: Chief resident in general surgery, University of California San Francisco

FELLOWSHIPS 1990–1991: Vascular fellowship, UCSF 1986–1988: Postdoctoral research fellowship, Scripps Clinic, La Jolla, USA

We were able to enrol patients in numerous clinical trials even though we were in an isolated setting in a community hospital. Part of the advantage of our site was that we were able to include many patients who were considered underrepresented minorities. The trials that I felt were most significant included IN.PACT SFA and ROADSTER 2. IN.PACT SFA was a landmark femoral popliteal drug-coated balloon (DCB) randomised controlled trial (RCT) study that immediately established a standard for ‘best in class’ which continues today, more than 10 years later. The other study of which I am quite proud is ROADSTER 2. In this prospective, neurologically adjudicated, US Food and Drug Administration (FDA)-mandated study of transcarotid artery revascularisation (TCAR), the majority of cases were performed by new users, as opposed to previous carotid stent trials which required substantial experience of the operating physicians. The stroke and death risk in ROADSTER 2 was quite low and I believe also established a standard which subsequent carotid trials aimed to meet.

Could you tell us about Endovascular Skills?

I wrote Endovascular Skills in the early 1990s, partly out of concern that it was nearly impossible for practicing surgeons and vascular trainees to receive endovascular training. In an unanticipated manner, this endeavor turned out to be one of the most fun aspects of my career as doctors from around the USA and around the world have often approached me to mention that they used the texbook as a guide when they started their catheter experience. When I started working on the book, I was finishing fellowship. I had a strong interest in catheter-based techniques, and I could see that this approach would gradually improve and become an important part of what we could offer our patients. I started to put together resources including notes from cases, from the materials and methods of journal articles and ideas from conferences. In the first couple of years of my career I continued to build on this. I would frequently hear that there was a lack of resources to help with the building phase of understanding and planning and being aware of what the specific choices were for endovascular approaches. Endovascular Skills became a single-author book in the mid 1990s and it is currently in its fourth edition. I have added to it over the years as the technologies have become more sophisticated and more devices have become available. It is intended

Issue 100 | November 2023

alisonlang.com

Interview 17

to be relatively conversational and algorithmic and contains a lot of simple drawings that assist the reader in conceptualising where the procedure is going. My hope was that by putting this together, it would accelerate the progress of others. As a consequence, I have met people from all over the world who have used the text as a fellow or some early time frame of their careers and who benefited from it.

What are some of your current research interests?

I continue to be highly interested in the challenges of lower extremity salvage and also the safe reconstruction of carotid bifurcation disease. In addition, I believe that calcification has evolved over the years, has become endemic and extensive, and that there is tremendous opportunity for improvement in the prevention of calcification and in the management of it once it occurs. Calcification defies TASC classification, is across organ systems, and makes both open and endovascular reconstruction more difficult.

I see this as an area ripe for research and development in the coming years. In addition, during lower extremity revascularisation, I believe that there is likely substantial embolisation occurring at a subclinical level and may be causing long-term harm.

Could you outline one of your most memorable cases?

We have all had many memorable cases. We take our complications personally. It is nice to recall a time when on-the-spot thinking or perhaps luck helped to salvage an extreme situation. In the late 1990s, before we had the availability of EVAR, I operated on a ruptured aortic aneurysm. The patient and no detectable blood pressure and prior to the repair, I floated an aortic occlusion balloon under fluoroscopy. Upon balloon inflation, the patient immediately stabilized, allowing us to make an abdominal incision and get control of the aorta and do the repair. I believe the patient would have died if the classic open repair had been performed without prior balloon control. This patient was not recognised by me at the

“I believe that we are on the precipice of the next major acceleration in advancements.”

time of the emergency, however turned out to be one of my children’s school teachers. Subsequently, there was a lot of talk about this in the community as the patient went through a variety of challenges on his way to recovery. The patient subsequently quit smoking, finished out a career as a school teacher, and became a writer. This is why we do what we do. It was such a great reminder.

What advice would you give to someone looking to start a career in medicine? The ability to do meaningful work, help those in need, develop your skills, push yourself toward lifelong learning, and have some important say over how the work should be done, are all key facets of a rewarding career. This is the possibility that you have with a career in medicine. It is a gift.

What are your hobbies and interests outside of medicine?

My lifelong passion outside of medicine is surfing and my personal relationships with my family and friends.

November 2023 | Issue 100

18 Opinion

AORTIC

Researchers urge increased focus on health-related quality of life in acute type B aortic dissection patients In a recently published study, long-term health-related quality of life (HRQoL) was found to be seriously impaired in acute type B aortic dissection patients compared with the Dutch general population, especially regarding physical status. According to authors Frederike Meccanici (Erasmus University Medical Centre, Rotterdam, The Netherlands) and colleagues, this finding “warrants more attention for HRQoL during clinical follow-up”. WRITING IN THE EUROPEAN JOURNAL of Vascular and Endovascular Surgery (EJVES), Meccanici et al describe acute type B aortic dissection as a “rare yet serious cardiovascular event” that might have an impact on HRQoL. They note that the aim of the present study was to review long-term HRQoL among patients treated for acute type B aortic dissection, as data on this outcome are currently “scarce” in the literature. The investigators conducted a multicentre, crosssectional survey study, in which they retrospectively included consecutive patients with acute type B aortic dissection treated between 2007 and 2017 in four referral centres in The Netherlands. Meccanici and colleagues write that, between 2019 and 2021, the 36-item short form survey (SF-36) was sent to all 263 surviving patients and was compared with validated

SF-36 scores in the Dutch general population stratified by age and sex. The authors report in EJVES that a total of 144 of 263 surviving patients completed the SF-36, representing a response rate of 55%. They note that the median age of the respondents was 68 (interquartile range 61–76) years at completion of the questionnaire, and 40% (n=58) were female. Furthermore, they detail that initial treatment was medical in 55% (n=79), endovascular in 41% (n=59), and surgical in 4% (n=6) of the patients. Median follow-up time was 6.1 years. Meccanici et al report that, compared with the general population, patients scored “significantly worse” on six of eight SF-36 subdomains, particularly physical domains. They add that apart from bodily pain, there were “no substantial differences in

Is it possible to make descending thoracic aortic guidelines in view of the low evidence?

Kevin Mani Point of View Kevin Mani (Uppsala, Sweden) writes that a forthcoming guidelines document on descending thoracic aortic (DTA) diseases “does not shy away” from providing solid recommendations despite there being limited Level A evidence available.

or a patient affected by an acute ruptured type B aortic dissection, the lack of Level A evidence to support a treatment that may save his or her life is quite irrelevant—an intervention is required to stop the bleeding. As the vascular surgeon in charge of trying to save this patient’s life, you will have to make challenging and important decisions, that may result in success, or have catastrophic consequences. Even if it may seem simple enough to suggest that a thoracic aortic rupture should be sealed off with

a thoracic endovascular aortic repair (TEVAR), those of us who perform this procedure would know that this “simple” treatment requires several key decisions—how much sealing zone is required? What to do with the covered left subclavian? What about oversizing? How far down do you extend the repair? How to manage risk for paraplegia? And what to do with the haemothorax? The European Society for Vascular Surgery (ESVS) DTA guidelines aim to provide guidance on accurate

HRQoL between male and female acute type B aortic dissection patients”. They also relay that females scored “significantly worse” on five of eight subdomains compared with sex-matched normative data, whereas males scored “significantly lower” on six subdomains. Furthermore, Meccanici and colleagues share that younger patients, i.e. those ages 41–60 years, seemed more severely impaired in HRQoL compared with the age-matched general population. Treatment strategy did not influence HRQoL, and follow-up time was associated with better physical and mental component summary scores. The authors recognise “several” limitations that apply to their study. They acknowledge, for example, that no baseline HRQoL scores at the time of onset of disease were available, and HRQoL was assessed at one time point during follow-up. This resulted in the investigators not being able to perform a time trend analysis. In addition, Meccanici et al highlight that some non-responder bias was present, and that survival bias might also have affected their results. They also state that, as the participating centres were tertiary referral centres, the proportion of uncomplicated type B aortic dissections in the study might be lower than in clinical practice, limiting the findings’ generalisability. Looking ahead, the authors urge that “HRQoL should be an integrated part of the clinical follow-up” and write that physical rehabilitation in particular “might improve HRQoL in patients with acute type B aortic dissection”.

diagnostic methods and effective treatment strategies for patients with DTA diseases, including regarding several of the questions above. The ESVS DTA guidelines were first published in 2017 and were then the first comprehensive guidelines on the management of DTA diseases published by a vascular surgical society. This document included a total of 80 recommendations, 90% of which were based on consensus opinion of experts and/or retrospective studies. Not a single recommendation achieved Level A evidence, i.e. being based on data from multiple randomised trials. Is this to be regarded as failure for a clinical practice guidelines document by a scientific society? As a matter of fact, the need for clinical practice guidelines is probably even more acute in scenarios where the evidence for what is exactly the correct decision is lacking. When a recommendation can be supported by multiple randomised trials, one would assume that the clinical practice is already homogenised according to this evidence; whilst the need for guidance is more obvious when strong evidence is lacking. The ESVS DTA guidelines are not alone in including recommendations which lack level A evidence. To put this into perspective, in ten clinical practice guidelines published by the ESVS over the past six years, the proportion of recommendations based on Level A evidence has varied from 2% (in graft infections guidelines) up to 21% (in venous thrombosis guidelines). In the cardiology field, where randomised trials are much more prevalent than in vascular surgery, the proportion of

guideline recommendations supported by evidence from multiple trials is merely 8–14% (Fanaroff et al, Journal of the American Medical Association 2019). The updated ESVS DTA guidelines have been under development over the past two years. This process has involved systematic review of the literature in the field of DTA pathology, and development of key recommendations aiming to assist clinicians in specific clinical situations. For each recommendation, the available evidence is evaluated using the modified European Society of Cardiology (ESC) grading system. Fourteen experts in the field of DTA have formed the writing committee, and the guidelines are scrutinised by dedicated reviewers. This process is the basis for the recommendations that may lack Level A evidence and are expert opinion interpretations of available non-randomised studies. Although recommendations based on multiple randomised trials are scarce also in the new DTA guidelines, the document does not shy away from providing solid guidance on how to tackle some of the most challenging situations vascular surgeons and patients face when dealing with DTA diseases. The updated guidelines will be released in 2024 and will clearly demonstrate that it is possible to make DTA guidelines despite the low evidence. Kevin Mani is professor of vascular surgery at Uppsala University in Uppsala, Sweden, and a member of the ESVS DTA guidelines committee.

Issue 100 | November 2023

Spinal Cord Ischaemia 19

Preventing spinal cord ischaemia: Novel techniques for direct segmental artery revascularization show promise, WVS 2023 hears A VASCULAR SURGERY team from the University of Southern California (USC) in Los Angeles, USA, demonstrated the feasibility of multidisciplinary direct revascularisation of segmental arteries to prevent spinal cord ischaemia (SCI) using novel endovascular or extra-anatomic bypass techniques in high-risk patients with complex thoracoabdominal aortic aneurysms (TAAAs) following a retrospective review of fenestrated or branched endovascular aneurysm repairs (F/ BEVARs) over a five-year period, attendees of the recent Western Vascular Society (WVS) annual meeting (9–12 September, Koloa, USA) were told. The early work, which involves 12 patients undergoing either an endovascular or open approach, was hailed by audience member Benjamin W Starnes, chief of vascular surgery at University of Washington Medicine in Seattle, USA, who said, “This is a new idea. I applaud the courageousness of our colleagues at USC for pursuing this.”

USC integrated vascular surgery resident Anand Ganapathy, who presented the study results, told WVS 2023 that nine patients were treated endovascularly, with a total of 11 segmental arteries incorporated. Ganapathy outlined how seven were revascularised using a directional cuff sewn directly onto a physicianmodified graft that was extended with self-expanding Viabahn stents (Gore Medical); two of the arteries were treated using stented fenestrations; and the remaining two—located along the seal zone—were tackled using unbridged, large fenestrations without covered branched stents. The other three patients received an extraanatomic bypass. Extents I and II were the most common type of TAAA among the patient group, Ganapathy continued. Procedural details for endovascular repair of the aneurysms demonstrated an average of 4.3 target vessels (2–6) treated, with a technical success rate of 83%. Failures (two patients) involved a bridging stent to a renal artery “that was dislocated from the fenestration and not

recoverable” and a malalignment of an unstented fenestration to an intercostal artery “maintained with an uncovered stent.” Nine patients had successful prophylactic spinal drain placement. The three patients who underwent open repair of their segmental arteries received their bypass an average of three days prior to the F/BEVAR procedure. Ganapathy reported no mortality at 30 days post-procedure. Two patients—one who had a staged extraanatomic bypass, the other an unstented fenestration—incurred spinal cord ischaemia that “resolved completely by discharge.” Both had prophylactic spinal drain placement. Average follow-up was 472 days. Three of the 14 targeted segmental arteries occluded during follow-up, Ganapathy added.

Patient selection is everything—”

Senior author Sukgu Han Occluded branches involved one extraanatomic bypass and two directional cuffs. “They occurred beyond one year without causing spinal cord ischaemia,” he said. Ganapathy concluded: “Spinal cord ischaemia remains a serious complication of F/BEVAR, despite

current mitigation strategies. Our initial experience demonstrates feasibility of endovascular and extra-anatomic bypass for segmental revascularisation in select patients. Further work is planned to improve patient selection through anatomic and dynamic assessment of spinal cord perfusion patterns, as well as the safety and efficacy of segmental artery revascularisation procedures through a multidisciplinary, collaborative effort across expertise from a growing list of specialists. Our vision is that someday this might serve as another adjunct to the current spinal cord ischaemia mitigation protocols.” Karthikeshwar Kasirajan, a clinical professor of vascular surgery at Stanford University in Stanford, USA, who was the designated discussant of the paper at WVS, summarised the study’s headline findings, outlining how the novel techniques had been employed in 3.8% of F/BEVAR patients reviewed during the study period. Some 11% of the endovascular group and 33% of the open group developed transient paraplegia, he said. Kasirajan commented: “In my opinion, it should be noted that stent grafts have a lower instance of paraplegia when compared to open repairs in general. This is despite the fact that length of coverage is often more extensive as to require landing zones that are much more extensive than open repairs.

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November 2023 | Issue 100

20 Latest News

AORTIC

Randomised trial identifies potential long-term mortality benefit of supervised exercise programme prior to AAA repair IN A RANDOMISED controlled trial (RCT) of 124 patients, researchers found that attending a supervised exercise programme (SEP) prior to undergoing elective abdominal aortic aneurysm (AAA) repair was associated with a five-year mortality benefit. Writing in the Journal of Vascular Surgery (JVS), Sifut Sethi (Hull York Medical School, Hull, UK) and colleagues state that a preoperative SEP improves cardiorespiratory fitness and perioperative outcomes for patients undergoing elective AAA repair. They note that it was the aim of the present study to assess the effect of a preoperative SEP on the longterm survival of these patients and, secondarily, to consider long-term differences in cardiorespiratory fitness and quality of life. The authors share that, prior to the current analysis, patients scheduled for open or endovascular AAA repair were randomised to either a sixweek preoperative SEP or standard

management, and a significant improvement in a composite outcome of cardiac, pulmonary and renal complications was seen following SEP. In the present study, patients were followed up to five years post surgery, with all-cause mortality as the primary outcome. In their methods section, Sethi et al detail that data were analysed on an intention to treat and per protocol basis, explaining that the latter meant patients randomised to SEP who did not attend any sessions were excluded. The per protocol analysis, the authors continue, was further interrogated using a complier average causal effect analysis on an ‘all or nothing’ scale, which they note adjusts for compliance. Additionally, the authors convey, patients who agreed to longterm follow-up attended the research centre for cardiopulmonary exercise testing and/or provided quality-of-life measures. The intention to treat analysis, Sethi and colleagues reveal in JVS,

demonstrated that the primary endpoint occurred in 24 of the 124 participants at five years, with eight in the SEP group and 16 in the control group (p=0.08). Furthermore, they report that the per protocol analysis demonstrated a significant survival benefit associated with SEP attendance (four vs. 16 deaths; p=0.01). The researchers add that the complier average causal effect analysis confirmed a “significant intervention effect” (hazard ratio, 0.36; 95% confidence interval, 0.16–0.9; p=0.02), and that there was no difference between groups for cardiorespiratory fitness measures and most quality of life measures. Sethi et al acknowledge a series of limitations to their research. For example, they note that they were unable to collect specific data on

Further welldesigned RCTs considering the role of preoperative SEP for patients undergoing AAA repair are required.”

complications for several patients, and therefore the role of preoperative SEP on long-term complications “remains unknown”. Additionally, the authors write that the use of a per protocol analysis “may weaken the findings” of the present study; however, they stress that this effect “should be minimised” by the additional complier average causal effect analysis. Furthermore, with regard to cardiopulmonary exercise testing and quality-of-life data, Sethi and colleagues underline the fact that only a small proportion of participants who were still alive provided these data, which they label as a “clear limitation” of their results. Finally, the researchers stress that “it is possible that unmeasured confounding events could have occurred during the follow-up period, affecting the results”. They explain, however, that as these are not known, they could not be accounted for during analysis. Sethi et al conclude: “These novel findings suggest a long-term mortality benefit for patients attending a SEP prior to elective AAA repair.” They recognise, however, that the underlying mechanism behind this remains unknown. “Further well-designed RCTs considering the role of preoperative SEP for patients undergoing AAA repair are required,” the authors state in closing.

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Issue 100 | November 2023

Advertorial 21

THIS ADVERTORIAL IS SPONSORED BY SHAPE MEMORY MEDICAL

The path toward the gold standard in clinical evidence—a randomised controlled trial

In focus: smart polymer treatment of abdominal aortic aneurysm (AAA) sacs during endovascular aneurysm repair (EVAR).

mart polymer device treatment of the flow lumen outside of an endograft during elective EVAR is an exciting prospect, Shape Memory Medical tells Vascular News. Smart polymer devices have numerous properties that formed the basis of an initial investigation into their potential to improve AAA sac behaviour: a porous matrix that supports thrombus formation throughout its structure. The open-cell structure of smart polymer also contributes to its radiolucency, low radial force, and conformability (Figure 1). Prospective single-arm studies in New Zealand NCT04227054 and The Netherlands NCT04751578 developed a technique to manage the AAA sac outside of an endograft with IMPEDE-FX RapidFill during EVAR.1 A guidewire and delivery sheath are placed in the blood lumen, outside the endograft where the smart polymer is delivered throughout the AAA sac (supplemental video in doi:10.1016/j.jvscit.2023.101241).1 The studies have completed enrolment, and one-year results are currently being written up for publication (Figure 2). With feasibility study data in hand, what is next for smart polymer technology and EVAR? Shape Memory Medical recently announced that the US Food and Drug Administration (FDA) granted investigational device exemption (IDE) for a prospective, multicentre, randomised, open-label trial to compare the performance of smart polymer treatment of a AAA sac during EVAR versus standard EVAR as a control (Figure 3). The design of the AAA-SHAPE Pivotal Trial (NCT06029660) incorporates contemporary ideas in AAA treatment. A key endpoint is the change in AAA volume. Aortic diameter is currently the gold standard measure for

AAA and EVAR. However, rapidly emerging data and analyses suggest aneurysm volume may be an earlier and more sensitive marker of changes in AAA morphology than diameter in surveillance,2–4 treatment thresholds, and interventional followup.5–8 Imaging technology is also rapidly evolving to facilitate the use of volume measurement in clinical practice, both for computed tomography (CT)9,10 and three-dimensional ultrasound11–14 assessments. Since volumetric measurements are three dimensional, they are able to detect minor changes compared to two-dimensional diameter changes. Therefore, both volume and diameter should be measured.20 Endicott and Simons recently noted: “Current aneurysm guidelines utilise sac stability as an endpoint for successful EVAR; however, recent studies have suggested that a stable (not shrinking) sac may in fact portend increased mortality with time.” They suggest “how success of EVAR is defined in terms of sac behavior” as a priority for the field.15 Indeed, numerous retrospective studies have recently linked an absence of sac regression to increased mortality.16–19 The results of the prospective AAA-SHAPE Pivotal Trial, with standard EVAR as the control and sac treatment with smart polymer under investigation, will generate high-quality data to describe AAA sac behaviour post EVAR, regardless of the arm. The primary endpoint will explore the effectiveness of the approach and long-term followup will explore whether smart polymer improves patient outcomes post EVAR. “We look forward to the journey ahead and the collaboration with our clinical investigators in the USA and Europe,” Shape Memory Medical shares with Vascular News.

References 1. H olden A, Hill AA, Khashram M, et al. Active aortic aneurysm sac treatment with shape memory polymer during endovascular aneurysm repair. J Vasc Surg Cases Innov Tech. 2023;9(3):101241. 2. R istl R, Klopf J, Scheuba A, et al. Comparing maximum diameter and volume when assessing the growth of small abdominal aortic aneurysms using longitudinal CTA data: Cohort study. Int J Surg. 2023. 3. O lson SL, Panthofer AM, Blackwelder W, et al. Role of volume in small abdominal aortic aneurysm surveillance. J Vasc Surg. 2022;75(4):1260– 1267 e1263. 4. Renapurkar RD, Setser RM, O’Donnell TP, et al. Aortic volume as an indicator of disease progression in patients with untreated infrarenal abdominal aneurysm. Eur J Radiol. 2012;81(2):e87–93. 5. Fillinger M, Excluder Bifurcated Endoprosthesis Clinical I. Threedimensional analysis of enlarging aneurysms after endovascular abdominal aortic aneurysm repair in the Gore Excluder pivotal clinical trial. J Vasc Surg. 2006;43(5):888–895. 6. van Keulen JW, van Prehn J, Prokop M, et al. Potential value of aneurysm sac volume measurements in addition to diameter measurements after endovascular aneurysm repair. J Endovasc Ther. 2009;16(4):506−513. 7. Franchin M, Serafini M, Tadiello M, et al. A morphovolumetric analysis of aneurysm sac evolution after elective endovascular abdominal aortic repair. J Vasc Surg. 2021;74(4):1222–1231 e1222. 8. G unerhan Y, Isik M, Dereli Y, et al. Assessing volumetric changes in abdominal aortic aneurysms following endovascular repair. Cardiovasc J Afr. 2021;32(4):182–187. 9. Caradu C, Pouncey AL, Lakhlifi E, et al. Fully automatic volume segmentation using deep learning approaches to assess aneurysmal sac evolution after infrarenal endovascular aortic repair. J Vasc Surg. 2022;76(3):620–630 e623. 10. Spinella G, Fantazzini A, Finotello A, et al. Artificial intelligence application to screen abdominal aortic aneurysm using computed tomography angiography. J Digit Imaging. 2023. 11. Zielinski AH, Bredahl KK, Ghulam QM, et al. Full-volume assessment of abdominal aortic aneurysm by improved-field-of-view 3D ultrasound performs comparably to computed tomographic angiography. Ultrasound Med Biol. 2022;48(2):283–292. 12. Zielinski AH, Bredahl KK, Ghulam QM, et al. One-year volume growth of abdominal aortic aneurysms measured by extended field-of-view ultrasound. Int Angiol. 2023;42(1):80–87. 13. Khan M, Rogers S, Carreira J, et al Aneurysm geometry analyzed by the novel three-dimensional tomographic ultrasound relates to abdominal aortic aneurysm growth. Ann Vasc Surg. 2022;87:469–477. 14. Maas EJ, Nievergeld AHM, Fonken JHC, et al. 3D ultrasound-based mechanical and geometrical analysis of abdominal aortic aneurysms and relationship to growth. Ann Biomed Eng. 2023. 15. Endicott KM, Simons JP. Essential innovation and clinical trial needs in vascular care: Aortic. Endovascular Today. https://evtoday.com/ articles/2023-aug/essential-innovation-and-clinical-trial-needs-invascular-care?c4src=current:feed. Published 2023. Accessed Sept 2023. 16. O’Donnell TFX, Deery SE, Boitano LT, et al. Aneurysm sac failure to regress after endovascular aneurysm repair is associated with lower long-term survival. J Vasc Surg. 2019;69(2):414−422. 17. Al-Tawil M, Muscogliati E, Jubouri M, et al. Correlative effect between sac regression and clinical outcomes following endovascular repair in abdominal aortic aneurysm: Fact or myth? Expert Rev Med Devices. 2023;20(8):643–650. 18. Pla Sanchez F, Martinez Lopez I, Hernandez Mateo MM, et al. Prognostic value of initial aneurysmal sac regression after evar. Ann Vasc Surg. 2020;64:109–115. 19. Boer GJ, Schroder LBW, Disli MC, et al. A stable aneurysm sac after endovascular aneurysm repair as a predictor for mortality: An in-depth analysis. J Vasc Surg. 2022;76(2):445–453. 20. van Keulen JW, van Prehn J, Prokop M, et al. Potential value of aneurysm sac volume measurements in addition to diameter measurements after endovascular aneurysm repair. Journal of endovascular therapy: an official journal of the International Society of Endovascular Specialists. Aug 2009;16(4):506–13. doi:10.1583/09-2690.1

Disclaimers: The content contains information about the AAA-SHAPE Pivotal Trial, Shape Memory Medical’s prospective, multicenter, randomized, open-label trial of the IMPEDE-FX RapidFill when used for prophylactic abdominal aortic aneurysm (AAA) sac filling during elective endovascular aneurysm repair (EVAR). For more information about the AAA-SHAPE Studies, please visit https://clinicaltrials.gov/study/NCT06029660. In countries recognizing CE marking, IMPEDEFX RapidFill is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature. The IMPEDE-FX RapidFill device is not approved for sale in the United States. Caution – INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL (OR UNITED STATES) LAW TO INVESTIGATIONAL USE.

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Issue 100 | November 2023

Latest News 23

VENOUS

Adoption of new techniques will stumble if policy and hospital buy-in are hurdles “What evidence do we need to see before a technique is adopted?”. Erin Murphy, of Atrium Health’s Sanger Heart and Vascular Institute in Charlotte, USA, posed this question to attendees of the International Union of Phlebology (UIP) World Congress (17–21 September, Miami, USA). THE FIVE PHASES OF technology adoption are “pretty well understood”, Murphy noted, before listing the order of users: the innovators, the early adopters, then—once a certain tipping point is reached—the early majority, the late majority, and the laggards. “And of course”, she added, “There are some who just never get there”. What influences this pathway, and how fast the adoption of new technologies or techniques happens, is “where the discussion is”, according to Murphy. Two factors contribute to the rate of adoption: First, is the “indication of attractiveness” (to what extent an innovation is perceived as better than the current standard), and second, is creation of a “facilitating environment” in which new innovations can flourish. This means the removal of barriers or the establishment of the necessary infrastructure or institutional frameworks. In the clinical setting, a product

being “better” could mean that it is more effective, safer, easier to use, cheaper, or more time efficient. If it meets a clinical need and is perceived as doing one or more of these things, its adoption looks promising. But Murphy cautioned: “No matter how good the innovation is, if you do not have an environment to facilitate use of the technology, then adoption will fall short”. An enabling environment includes policy support, insurance coverage, institutional endorsement (relevant for some healthcare systems), product education and support, as well as an awareness of product marketing. Policy support includes insurance policy coverage and hospital policy buy-in. Doctors, institutions, and societies can all play a part in steering policy development, and thus the adoption of new technologies and techniques, through the penning of guidelines and consensus statements and via the

publication of outcome data. Education is also important. “Fellowships are a means to advance— not necessarily products—but knowledge itself.” Conferences and societies play a pivotal role in education beyond the training years, potentially providing a stage for innovation to disseminate. Murphy conveyed to the delegates: “Industry funds the lion’s share of post-fellowship education and therefore plays a crucial role in product and field education.” Addressing industry representatives specifically, she emphasised: “It is imperative to have knowledge of the field and confidence in how your product adds to it. Assist individuals in navigating its usage and offer educational resources and honest support.” The impact of marketing can swing both ways, either encouraging or dissuading the adoption of a particular innovation. Drawing from her own experiences, Murphy shared: “I can attest that misleading and untruthful marketing has steered me away from certain product options. Transparent, instructive, non-pushy marketing is truly the most effective approach.” The degree of volunteerism is another facet of environment that drives or limits adoption. When faced with an abundance of choices for a particular product or technique, it can lead to a lack of widespread acceptance across the board. For a Erin new innovation to gain Murphy

Survey suggests venous work less valued than arterial interventions

universal traction, it is advantageous if it supersedes an existing option or there is limited choice in product use. The increase in virtual medical appointments since 2020 is an illustrative example of rapid adoption. For nearly two decades before the advent of the COVID-19 pandemic, virtual visits were already in existence. “They were being discussed and utilised in rural areas,” Murphy reminisced. Virtual visits were adopted so quickly because there was a clinical need for patients to meet with their doctors, these types of visits were perceived as better, and an enabling environment was swiftly established. In terms of being perceived as better, these visits were seen as safer. They were also deemed necessary and effective for basic-level care, as virtual visits prevented patients from avoiding treatment for routine medical issues that they would not have come in for otherwise. Billing codes for virtual visits were rolled out, the hospital system provided training to medical professionals, and doctors received product support. Further, hospitals required the use of virtual visits as there were limited options for seeing patients safely at the time, essentially eliminating volunteerism. “Clearly, virtual visits during [the start of the] COVID-19 [pandemic] checked all of the boxes,” Murphy said, referring to her list of conditions that influence adoption of a novel technique.

with no differences found in age or gender between the venous-heavy and venous-light practices. They continue that those with a venous-heavy practice had significantly more years in practice statistically (p=0.02), had sought more venous training after The majority of more than 300 vascular surgeons who responded to a recent survey graduation (p<0.0001), were more likely to be in indicated that they perceive the management of venous disease to be of less value private practice (p<0.0001), and were more likely to than that of arterial disease. Investigators Misaki M Kiguchi, of MedStar Washington desire a practice change (p=0.001) compared with Hospital Center in Washington, DC, USA, and colleagues share this and other key those with a venous-light practice. findings in the Journal of Vascular Surgery: Venous and Lymphatic Disorders. Kiguchi and colleagues report that, overall, 74.3% of respondents indicated that venous work might BY WAY OF BACKGROUND TO THEIR In terms of race and ethnicity, Kiguchi and be less “valued” than arterial work in the field of study, the authors note that biases and gender colleagues state that 63% of respondents identified vascular surgery. On multivariable regression, they disparities influence career pathways in medicine, as white (non-Hispanic), 17.1% Asian or Asian detail, the predictors for the perception of venous with vascular surgery being no exception. They Indian, 8.4% Hispanic, Latinx, or Spanish, 1.6% work being less valued were female gender (odds continue that, despite venous disease comprising Black. The remaining 9.9% selected ‘unknown’ for ratio 2.01, 95% confidence interval 1.14–4.03) and an estimated 1–3% of total healthcare expenditures, this category. completion of a vascular surgery fellowship (odds its value among vascular surgeons is ill defined. Nearly half of respondents (47%) shared that their ratio 2, 95% confidence interval 1.15–3.57). It was the aim of the present study to address this, practice setting was academic, compared to 26.5% In their conclusion, Kiguchi et al state that by investigating the factors that influence vascular private practice, 23.3% hospital employed, and vascular surgeons perceived the management of surgeons’ current perceptions of superficial and deep 3.2% ‘other’. venous disease to be of less value than that of venous disease treatments. The investigators also note that the female arterial disease, particularly by women and Kiguchi et al share that an anonymous survey respondents were “significantly” fellowship-trained vascular surgeons. was distributed electronically to practising vascular younger than their male counterparts “The prevalence of venous disease, surgeons in December 2021, with respondents (p<0.0001). In addition, they as measured by its proportion of the stratified by gender and practice breakdown. They had fewer years in practice US healthcare budget, cannot be detail that a venous-heavy practice was defined as (p<0.0001) and were more likely overstated,” the authors state. respondents perceived one with venous work comprising ≥25% of the to perceive a gender bias within As a result, they stress that venous work to be less total volume. a career encompassing venous “efforts to elevate the importance “valued” than arterial work in the field of The investigators note that a total of 315 practising disease compared with the male of chronic venous disease within vascular surgery vascular surgeons responded to their survey, with a respondents (p=0.02). the scope of vascular surgery majority of 81.5% from the USA. The respondents Of the 315 participants in the practices are essential to ensure had a mean age of 46.6±9.6 years, the authors detail, survey, Kiguchi et al relay that 143 patients are provided with appropriate and almost two-thirds (63.3%) identified as men. (45.4%) had a venous-heavy practice, specialty care.”

74.3% of 315

November 2023 | Issue 100

24 Latest News

VENOUS

Multi-society guidelines on varicose vein management published The Society for Vascular Surgery (SVS), American Venous Forum (AVF), and American Vein and Lymphatic Society (AVLS) have released the second and final part of new guidelines for the management of varicose veins of the lower extremities. The recommendations, which update the 2011 SVS and AVF guidance on the topic, were published online ahead of print in the Journal of Vascular Surgery: Venous and Lymphatic Disorders (JVS-VL). THE NEW DOCUMENT FOCUSES ON THE on evaluation with duplex scanning and on the following topics: management of superficial truncal reflux in patients ● Evidence supporting the prevention and management with varicose veins”. However, the authors recognised of varicose vein patients with compression “several additional important clinical issues” needed ● Treatment with drugs and nutritional supplements to be addressed, despite many having varying levels ● Evaluation and treatment of varicose tributaries of scientific evidence associated with them. For this ● Superficial venous aneurysms reason, when a systematic review was not available, ● The management of complications of varicose veins the writing committee based ungraded statements on and their treatment a comprehensive review of the literature, combined The publication—authored by Peter Gloviczki (Mayo with unanimous consensus of the expert panel. Clinic, Rochester, USA) and 19 other members of a Alongside a series of recommendations, the writing multispecialty guideline writing committee—follows committee highlight “several” knowledge gaps on the last year’s release of part one of the guidelines, natural history, evaluation, prevention and treatment which addressed duplex scanning and treatment of of patients with varicose veins, highlighting their superficial truncal reflux. top 20 recommendations for future research. Gloviczki and colleagues outline in their The most important three they identify introduction the reason behind the twoare comparative studies of polidocanol part publication of the updated guidelines. endovenous micro-foam versus physicianThey note that all recommendations in compounded foam for treatment of part one were based on a new, independent varicose tributaries, comparative studies of systematic review and meta-analysis that polidocanol endovenous micro-foam versus “provided the latest scientific evidence to other techniques of thermal and non-thermal Peter Gloviczki support updated or completely new guidelines ablation of incompetent superficial truncal

Quick, non-invasive, accurate: New PeVD screening tool holds potential “There is a pressing need for an effective, patient-centric and accurate screening tool” for pelvic venous disorders, says Tasneem G Pope, of Imperial College London in London, UK, speaking at the International Union of Phlebology (UIP) World Congress (17–21 September, Miami, USA). Diagnosing the disease is challenging, due to its multiformity and wide clinical presentation spanning multiple specialties. Now, one such novel screening tool shows promise. THIS NEW SCREENING TOOL FOR PELVIC venous disorders (PeVD) can help clinicians identify women suffering from the disease and facilitate early and appropriate referral to vascular specialties. PeVD has a significant impact on the quality of life of the women affected. When it was first independently described by Lo and Taylor in 1949, Lo attributed the symptoms and signs to the wearing of strong corsets. Today, women often spend months seeking medical attention from various specialties before receiving an appropriate vascular referral, Pope explains. The investigators therefore set out to assess the effectiveness of a screening questionnaire developed at the Venus Clinic in Singapore in identifying women with PeVD in a retrospective study. All patients referred to take the questionnaire were over 18 years old and had suspected PeVD. Patients completed a two-part screening questionnaire via an online platform. The first part is a six-item questionnaire largely derived from the International Pelvic Pain Consortium to determine a “basic” PeVD score, focusing on signs and symptoms commonly found in women suffering from PeVD. It was a binary score: answering “yes” gave a score of one, answering “no” scored zero. The

basic score could range from zero to six. Ninety-four women completed this section. The second section is a four-item adjunct added in 2022 to improve the accuracy of the screening tool. Answering “yes” for any of these questions was given greater weighting, scoring two. A “no” still scored zero, meaning the specific score could range from zero to eight. Thirty-four women (of the 94 who filled out the first part of the questionnaire) answered the fouritem Specific PeVD Score section. The two scores could be added together to give a combined score, with a maximum of 14. All women also underwent duplex ultrasound screening, and this was used as the reference standard.Both a higher basic score and a higher combined score was significantly positively associated with meeting the duplex ultrasound criterion for PeVD. In total, 73 women out of the 94 met the duplex ultrasound criteria, giving a prevalence of 78%. Of the 34 women who completed the specific score, the prevalence was 85%. In comparing the group comprising women that met the duplex ultrasound criteria with those that did not, there was no difference in mean age. However, the women meeting the duplex ultrasound criteria had a higher parity and higher number of vaginal

veins, and best metric of axial reflux to determine ablation of superficial truncal veins. Speaking to Venous News following the publication of these guidelines, Gloviczki commented: “These up-to-date, evidence-based recommendations are made by a 20-member multidisciplinary expert panel of three leading North American societies, dedicated to the care of patients with acute and chronic venous disease. This comprehensive document includes a list of practical recommendations, ungraded consensus statements, implementation remarks, and best practice statements to aid practitioners with the best and most appropriate management of patients with lower extremity varicose veins. It emphasises the superiority of endovenous techniques over conventional surgery, endorses both thermal and non-thermal ablation techniques and defines the role of compression, drugs and nutritional supplements. The guidelines address management of ablation-related thrombus extension (ARTE) after endovenous procedures and recommends best management of superficial thrombophlebitis, bleeding varicose veins and treatment of superficial venous aneurysms.”

These up-to-date, evidence-based recommendations are made by a 20-member multidisciplinary expert panel of three leading North American societies.” deliveries. Further studies, including validation of this tool in a larger prospective cohort and in a population with a low prevalence of the disease, are required. Pope recognised a limitation of the study being the potential for overdiagnosis of PeVD with the screening questionnaire—additional steps are needed in conjunction with the basic and specific scores to diagnose the disease. A UIP audience member noted that the study investigators had evaluated the relationship between the ultrasound-defined disease and the questionnaire score, but not between a clinical diagnosis and the questionnaire score, asking: “How confident are you in ultrasound’s ability to detect the disease?” Speaking from the floor, one of Pope’s coinvestigators responded that it was important to use the newly developed score appropriately. He clarified: “When someone presents to you with pelvic pain, do you do a pelvic duplex? A transvaginal duplex is invasive, regardless of what people say, that an ultrasound is not invasive. A transvaginal probe is invasive, these people are in pain, the psychology of it [is important]. Although it looks like we validated the ultrasound to validate the score, the score was developed because we wanted to see ‘Does the ultrasound actually fit? Do people with high scores actually have bad ultrasounds?’. This score is a start.” The moderator summarized: “A high score doesn’t mean you have PeVD. A high score means it is now fair to start investigating this woman for PeVD, because in the specific score, one aspect is ‘Have you had a laparoscopy and implant, a CT scan, gynecological examination for other gynecological conditions?’ And if it is no, in the score, you are more likely to have PeVD if other gynecological issues have been ruled that.”

Issue 100 | November 2023

Opinion 25

Strength in numbers: Adapting to life as a new vascular consultant

Claire Dawkins Point of View Claire Dawkins (Newcastle, UK) reflects on her first six months as a vascular consultant, championing the importance of her co-workers during this career step-up. just how powerful we are as a team. In isolation the demands placed upon us would rapidly overwhelm anyone. We have strength in numbers and I have found the team I have joined to be the most powerful asset I have in my practice, with their support I can achieve anything I set my mind to. I have called on their help clinically many times already. I recently realised how isolating being a consultant can be, especially at 3am when struggling to revascularise an ischaemic limb. Having a close team around, with people to call upon to share the challenging cases is vital. The hardest aspect was not being able to see

having theirs. But I am learning to look past the burnt carrots and see what is really causing me stress or upset. It is hard to do, because in that moment I just want to blame the carrots, but if I do that there will be another carrot the next day. Finally I have learnt that I need to look after myself. Prioritise my family and not say yes to everything. I have been told many times it is a marathon and not a sprint, but I still thought that I could do it all. Every opportunity sounds like something exciting and new, something I would enjoy. But in six short months I am close to overwhelming myself by not saying no. My advice to anyone starting out would be to really think about anything extra they take on, certainly within the first six months to a year, and not be afraid to say no. I have really enjoyed the transition from trainee to consultant, the fresh challenges have stretched me and I feel that I have grown rapidly into the role, although there is still much more I have to develop. There are many changes afoot within healthcare, particularly within the NHS. I am hopeful that together we can navigate these, improving patient care, working conditions and training. Claire Dawkins is a vascular consultant at the Newcastle Upon Tyne Hospitals NHS Foundation Trust in Newcastle, UK.

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t is a really tough time for everyone in healthcare, particularly in the UK National Health Service (NHS). A healthcare system on its knees, reeling from a global pandemic and an unprecedented year of strikes, held together, to a great degree, by the grit and goodwill of its staff. Navigating the transition from trainee to consultant was only made more complex during this turbulent time. While it feels hardly seconds ago that I took up my consultant post, it also feels like I have been doing this for years. Over the last six months I think the most important thing I have learnt is

a solution but not being ready to resign a patient to an amputation. I know that I could have called any of a number of my colleagues and they would have offered me advice, assistance and support whatever the hour. Fortunately my partner in crime overnight in interventional radiology came to my rescue, and together we knew we did everything possible. The thing that surprised me though was how much I would count on the team for non-clinical help, far more than I have clinically. They have helped me navigate complexities of professional relationships and interpersonal issues, training difficulties and managing the demands that consultant life brings. I hope in return I have provided them with support, and sufficient enthusiasm to make up for my lack of experience! Then there is my team at home. I certainly would not achieve what I am without the support of my husband, who accepts that the long hours and late nights are just part of what I do. The children whose games and laughter are my reinvigoration and family who are always there to support and babysit! I have also learnt a lot about myself. How I am ‘fine’ until all of a sudden I am not. Years ago, when I was cooking dinner for friends, I burnt the carrots. I had a meltdown, it was the end of the world that I had burnt them. But really it is not about the carrots, it is about everything else going on. I have had ‘carrot’ days and I have seen colleagues

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Issue 100 | November 2023

Market Watch 27

Clinical News

Passeo-18 Lux

Biotronik announces twoyear results from BIOLUX P-III BENELUX all-comers registry

Biotronik recently announced twoyear-results from the BIOLUX P-III BENELUX all-comers registry, presented by principal investigator Frank Vermassen (UZ Ghent, Ghent, Belgium) at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) annual congress 2023 (9–13 September, Copenhagen, Denmark). The prospective, international, multicentre postmarket registry evaluated the safety and efficacy of the Passeo-18 Lux drugcoated balloon (DCB) catheter in isolated popliteal artery lesions. The BIOLUX P-III BENELUX registry enrolled 99 patients in Belgium, The Netherlands, and Luxembourg with Rutherford 2–5 disease and at least two centimetres of healthy vessel segment between lesions in the popliteal artery and lesions in the distal superficial femoral artery. All patients were treated with the Passeo-18 Lux DCB. The bailout stenting rate was 14%. Biotronik reports that, at 24 months:  Freedom from clinically driven target lesion revascularisation (CDTLR) was 81.6%  Freedom from major target limb amputation was 98.0%  Freedom from all-cause of death was 89.4%  Significant improvement of Rutherford classification was observed for 88.1% of the patients “We face a scarcity of data evaluating endovascular therapy for isolated popliteal artery lesions, known as a difficult vessel bed to treat as we do not want to leave anything behind,” said Vermassen, chief of vascular and thoracic surgery at UZ Ghent. “It is encouraging to see that we can safely and effectively treat these lesions with a DCB-only approach.” “Biotronik is proud to be a leader in research of paclitaxel-coated balloons, striving to study device performance in the most challenging anatomy and patient characteristics,” said Stuart Perks, vice president of marketing, vascular intervention at Biotronik. “We repeatedly see the safety and effectiveness of Passeo-18 Lux DCB demonstrated in a diverse range of clinical presentations.”

Shape Memory Medical receives US FDA IDE approval to initiate head-to-head AAASHAPE trial

Shape Memory Medical recently announced that the US Food and Drug Administration (FDA) has granted investigational device exemption (IDE) for the company to begin a prospective, multicentre, randomised, open-label trial to determine safety and effectiveness of the Impede-FX RapidFill device to improve abdominal aortic aneurysm (AAA) sac behaviour when used with elective endovascular

Impede embolisation plug, expanded

aneurysm repair (EVAR). “Securing a first-round FDA approval for AAA-SHAPE marks a significant milestone in the clinical development of the novel shape memory polymer technology for treatment of aortic aneurysms,” said Ted Ruppel, president and chief executive officer of Shape Memory Medical. “Large studies report that 60% of aneurysms fail to regress or expand within one year following EVAR, a problem linked to rehospitalisations, secondary interventions, and increased mortality. AAA-SHAPE will directly compare EVAR plus sac management with Impede-FX RapidFill to stand-alone EVAR to determine whether shape memory polymer improves patient outcomes post-EVAR.” A press release details that AAASHAPE (Abdominal aortic aneurysm sac healing and prevention of expansion) will enrol 180 patients with infrarenal AAAs across 40 sites in the USA, Europe, and New Zealand. Study participants will be randomised 2:1, either to EVAR plus sac management with Impede-FX RapidFill (the treatment arm) or to standard EVAR (the control arm). Key endpoints will compare sac diameter and volume change, endoleak rates, secondary interventions, and mortality through five years. The investigational device, ImpedeFX RapidFill, incorporates the novel shape memory polymer, a proprietary, porous, polyurethane scaffold that is crimped for catheter delivery and selfexpands upon contact with blood. In AAA-SHAPE, Impede-FX RapidFill is intended to fill the aneurysm blood lumen around a commercially-available EVAR stent graft to promote aneurysm thrombosis and sac shrinkage. The AAA-SHAPE pivotal trial is

preceded by the AAA-SHAPE early feasibility studies which enrolled a combined 35 patients in New Zealand and The Netherlands. This early experience was recently described by Andrew Holden et al in the Journal of Vascular Surgery: Cases, Innovations, and Techniques. “The AAA-SHAPE early feasibility studies have been key to validating the procedural techniques and best practices that we will leverage in the pivotal trial,” said Marc Schermerhorn, chief of vascular and endovascular surgery, Beth Israel Deaconess Medical Center (Boston, USA) and principal investigator of the AAA-SHAPE pivotal trial. “We are excited to initiate this widely-anticipated trial in the USA and abroad.” Joining Schermerhorn as coprincipal investigators are Virendra Patel, chief of vascular surgery, New York Presbyterian/Columbia University Irving Medical Center (New York, USA) and Ross Milner, chief, Section of Vascular Surgery and Endovascular Therapy, University of Chicago Medicine (Chicago, USA). “We used to consider both aneurysm regression and Abdominal stability as aortic indicators of aneurysm a successful EVAR outcome. However, contemporary data reveal that stable sacs are not as benign as once thought and that any failure of the sac to regress is associated with higher long-term mortality,” said Patel. “Shape memory polymer is a meaningful advancement in AAA repair and has the potential to address these unmet needs.” Milner added: “I commend [Shape Memory Medical] on the decision to pursue a randomised controlled trial. This head-to-head study will offer the level 1 evidence the vascular community will seek to determine the potential role of shape memory polymer in the management of AAA patients.”

First US patient enrolled in SOCRATES short neck AAA trial

The first US patient has been treated as part of the SOCRATES trial (Short neck AAA randomised trial—ESAR and FEVAR), which compares the safety and performance of endosuture aneurysm repair (ESAR) with fenestrated endovascular aneurysm repair (FEVAR) for the treatment of abdominal aortic aneurysms (AAAs) with a short neck. The maiden procedure performed in the USA was carried out by Brant Ullery, the medical director of vascular and endovascular surgery at Providence Heart and Vascular Institute in Portland, USA, who is a SOCRATES trial co-principal investigator.

The randomised, postmarket, head-to-head study was designed to determine whether clinical outcomes of ESAR and FEVAR are equivalent in the treatment of infrarenal AAAs with a core lab-measured short proximal neck length of 4–15mm and minimal infrarenal sealing zone of 8mm, the trial’s sponsor, the Foundation for Cardiovascular Research and Education (FCRE), states. Organised globally by FCRE in collaboration with Medtronic as funding partner, it randomises patients 1:1 to either ESAR with the Endurant II/IIs stent graft system (Medtronic) and Heli-FX EndoAnchor system (Medtronic), or FEVAR with the Zenith fenestrated AAA endovascular graft (Cook Medical) or Anaconda fenestrated stent graft (Terumo). SOCRATES is slated to enrol approximately 204 patients at up to 40 sites globally. The prespecified safety endpoint is freedom from major adverse events through 30 days. The composite effectiveness endpoint is technical success at index procedure, freedom from type IA or type III endoleaks, freedom from aneurysm-related mortality, and freedom from secondary reinterventions through 12 months. Heli-FX has US Food and Drug Administration (FDA) clearance for distribution in the USA and CE-mark approval for distribution in Europe. Zenith Fenestrated is available in the USA and Europe, and Anaconda is available outside the USA. Speaking on the design of SOCRATES at this year’s Leipzig Interventional Course (LINC 2023; 6–9 June, Leipzig, Germany), Ullery’s co-principal investigator Giovanni Torsello, from St Franziskus Hospital in Münster, Germany, expanded on the intentions of the trial, which he stated is the “first comparative” study to compare ESAR and FEVAR. Torsello told LINC attendees how hostile aortic neck can lead to “loss of proximal seal over time,” noting how short necks are associated with increased risk of type IA endoleak and secondary procedures, ultimately asking: “How should we treat our patients with a short neck?” This is where SOCRATES seeks to step in. “If we can build the first comparative trial in the treatment of such patients, and we can learn more about the fate of those treated in these ways, it will be a fantastic trial,” Torsello said. The extension of trial enrolment to the USA from its initial European starting place would “make a great contribution to this prospective study,” he added.

November 2023 | Issue 100

28 Market Watch

Product News VasQ external vascular support

Laminate Medical announces US FDA clearance for VasQ AVF creation device

Laminate Medical Technologies has announced its flagship device, the VasQ external vascular support, has been cleared by the US Food and Drug Administration (FDA) for use to create arteriovenous fistulas (AVFs) for dialysis access. The device, designated by the FDA as a Breakthrough Technology, was cleared based on a de novo review of the 144-patient VasQ US pivotal study as well as a track record of safety and effectiveness of use in multiple studies from outside the USA. As recently published in the Journal of Vascular Access, VasQ patients in the VasQ study met the primary endpoint of improved primary patency (freedom from intervention plus adequate flow for haemodialysis) at six months. No serious adverse event associated with the device was reported over the two year study. Additional analysis comparing VasQ patients against claims data for traditional AVFs created by the same surgeons in the study, reported statistically superior rates of functional success (confirmed use of the AVF for dialysis), and reduced need for additional procedures. The result was central venous catheters (CVC), the primary source of hospitalisation due to infection in dialysis patients, were able to be removed in 80% of the patients within the first year as compared to 62% of unsupported fistulas as reported by the National Institute of Health’s United States Renal Data System. Ellen Dillavou, division chief of vascular surgery at WakeMed Hospital Systems (Raleigh, USA), stated: “I, along with other study investigators who have used the device, are excited that we can now offer VasQ to our fistula patients. We believe this will give our patients a better chance to receive a functioning fistula with fewer additional procedures and will allow earlier removal of central venous catheters before they lead to serious infections.” VasQ is a nitinol-based device implanted around the artery and vein during the surgical creation of an AVF. The device was designed to provide structural reinforcement of the mobilised vessels now freed from its native supporting tissue as well as guide a more stable arterial flow profile as it transitions into the vein. Magnetic resonance imaging as well as computational fluid dynamic models have supported the proposed mechanistic benefits of the VasQ design

products Regulatory Agency (MHRA) has designated three new approved bodies to increase the country’s capacity to certify medical devices. that have led to consistent beneficial TÜV SÜD, Intertek, and TÜV clinical outcomes in multiple studies, Rheinland UK join the four current Laminate claims. UK Approved Bodies, almost doubling “We are excited to finally bring current capacity for the certification VasQ to the dialysis patient population of medical devices in the UK, MHRA in the USA,” said Laminate CEO says in a press release. Tammy Gilon. “We could not be TÜV SÜD and Intertek have been more appreciative of our principal designated as UK Approved Bodies investigators as well as the global to assess and certify general medical community of dialysis access devices in accordance with Part II of physicians that saw the potential in the UK Medical Devices Regulations VasQ and produced the wealth of 2002. TÜV Rheinland UK has also data supporting the devices safety been designated to assess and certify and effectiveness.” general medical devices as well as in-vitro diagnostics in accordance CMS grants New Technology with Part IV. Add-on Payment for With the exception of the very Endologix’s Detour system lowest risk devices, manufacturers Endologix has announced that the must apply to a UK approved body for US Centers for Medicare & Medicaid UKCA certification. Products can only Services (CMS) recently be placed on the market granted a New Technology in England, Wales and Add-on Payment (NTAP) Scotland after they have for the Detour system, achieved certification. a US Food and Drug Laura Squire, MHRA Administration (FDA)chief healthcare quality designated Breakthrough and access officer said: Device, as part of its “By almost doubling Fiscal Year 2024 Hospital capacity for medical device Inpatient Prospective assessment in the UK, we Payment System. are supporting patients An Endologix press to access the safe and release notes that NTAP effective products they was created to facilitate need to protect their health. PTAB using the patient access for qualifying “Approved Bodies play Detour system new medical technologies a critical role in the supply that substantially improve the diagnosis of medical devices and expanding or treatment of Medicare beneficiaries. capacity has been a key priority for us As of 1 October 2023, CMS has been to support manufacturers to bring their providing hospitals with additional products to the UK.” device reimbursement when the Detour Before appointing an Approved system is used for eligible cases in the Body, the MHRA conducts a detailed hospital inpatient setting. assessment process to ensure that According to Endologix, organisations are stable and able to percutaneous transmural arterial bypass undertake impartial and objective (PTAB) with the Detour system offers conformity assessment activities, a novel approach to treating complex that they have an appropriate quality peripheral arterial disease (PAD), management system, the capacity and enabling physicians to bypass lesions competence to undertake assessments in the superficial femoral artery, by and the processes they use meet the using conduits routed through the relevant regulatory requirements. femoral vein via a transmural passage, After successful designation, the to restore blood flow to the leg. This MHRA monitors UK approved bodies’ approach is effective for patients with activities including by regular audits long lesions (20–46cm in length), those and by witnessing some of their audits that have already undergone failed of manufacturers. endovascular procedures, or those that may be suboptimal candidates for open SCAI: US FDA panel vote surgical bypass. “encouraging” for advance of “Receiving the NTAP designation renal denervation is a testament to the transformative The Society for Cardiovascular potential of the Detour system in Angiography & Interventions (SCAI) treating complex PAD. At Endologix, has welcomed the review of scientific we are deeply committed to pioneering data related to the premarket approval solutions that drive better patient applications for two renal denervation outcomes. With this added support systems, describing this as a “step from CMS for eligible patients, we are forward to advancing access to excited to see more patients benefit additional therapies for people with from this novel approach,” said Matt uncontrolled hypertension”. Thompson, president, and CEO The US Food and Drug of Endologix. Administration (FDA) Circulatory Systems Devices Panel met this UK MHRA adds capacity for week to review scientific evidence medical device certification on interventions aimed at reducing The UK’s Medicines and Healthcare blood pressure in patients with

hypertension, scrutinising data for two renal denervation systems—the Paradise system from Recor Medical and Medtronic’s Symplicity Spyral device—as tools to reduce blood pressure in adults with uncontrolled hypertension, who may be inadequately responsive to, or are intolerant to, anti-hypertensive medications. While the FDA panel voted in favour that available data supporting the efficacy and safety of both of the devices, votes differed on whether the benefits outweighed the risks. The committee voted unanimously in support of safety, eight to three in support of its effectiveness, with one member abstaining, and 10 voted the benefits outweigh risks while two disagreed for the Paradise system. For the Medtronic Symplicity Spyral device, the committee voted unanimously in support of safety, seven in support and six against on effectiveness, and six voted yes, seven against (with tiebreaker by chair) and one abstained on the benefits outweigh risks. In a statement, SCAI said that it is encouraged by the panel’s vote as a step toward advancing access to additional therapies for people with uncontrolled high blood pressure. “Advancements like renal denervation are imperative to enhancing shared decision-making that can lead to better treatment and outcomes for patients,” the statement reads. “The FDA, renal denervation industry and healthcare personnel community spent many hours working and collaborating closely on these trials and deliberations for the betterment of patients and the care they receive.” Ahead of the votes this week, SCAI released a position statement on renal denervation for hypertension regarding patient selection, best practices for optimal techniques, competence, training and organisational recommendations. In conclusion, SCAI agrees that device therapies targeting the renal sympathetic nervous system hold promise as adjuncts to abate or interventions to abolish hypertension, depending upon the underlying severity of blood pressure elevation. Appropriate patient selection, pre-procedure evaluation, careful procedural planning and technique, implementation of strict operator training standards and facility requirements are paramount to programmatic success. “It is important we continue to seek out new treatment options for patients, including the use of renal denervation, given the growing global prevalence of uncontrolled hypertension increase year over year,” George Dangas (Icahn School of Medicine at Mount Sinai, New York, USA), SCAI president, was quoted as saying in the statement. “The panel’s vote will allow physicians and patients access to a renal denervation procedure for the first time with the potential to improve the treatment and quality of life for those suffering from hypertension.”

Issue 100 | November 2023

Market Watch 29

Product News Zeus launches next-generation tubing for bioresorbable vascular scaffolds

Zeus recently announced that it has developed Absorv XSE oriented tubing, the newest member of the company’s family of bioabsorbable products. Available in a variety of resins and expanded size ranges, Absorv XSE provides a highly customisable platform for design and offers an alternative to metallic products implanted permanently in the human body, Zeus claims in a press release. “Our new Absorv XSE oriented tubing gives medical device manufacturers another tool in their design toolkit,” noted Carl Liebert, director of product management at Zeus. “As our customers set out to develop next-generation devices, this latest Zeus tubing platform helps them expand the types of applications they address and produce better overall designs.” According to Zeus, the versatility of Absorv XSE enables medical device manufacturers to explore bioresorbable vascular scaffold (BRS) applications beyond the treatment of coronary artery disease. Expanded applications within the cardiovascular system, peripheral vascular system, ear, nose, and throat (ENT), and related fields are now

within reach. By leveraging significant advancements in polymer processing, Zeus states that it offers the new, highly customisable Absorv XSE platform in multiple polymer options and expanded size ranges. Through customisation, device engineers can configure product properties to meet specific design requirements related to mechanical properties and absorption profiles. “The development of Absorv XSE required an in-depth approach,” said James Lindsey III, senior research engineer at Zeus. “By focusing intently on structure-property relationships and application-specific morphology development, we were able to develop a truly novel manufacturing process with new game-changing capabilities.” Medical device manufacturers can also rely on the dimensional uniformity of Absorv XSE, Zeus claims. Test results from MeKo MedTech, a business unit of MeKo Manufacturing e.K. and global leader in precision laser cutting, showed that longer lengths and improved wall thickness uniformity throughout the length of Absorv XSE tubing resulted in approximately 25% more usable scaffolds after laser cutting than the previous generation of Absorv oriented tubing. These findings translate to improved consistency, greater laser-cutting efficiency, and

more predictable outcomes for providing a better periprocedural design engineers. experience for the patient,” said Misaki “We developed Absorv XSE Kiguchi, vascular surgeon oriented tubing to address at MedStar Heart and shortcomings with firstVascular Institute generation bioresorbable (Washington DC, vascular scaffolds. USA). This next evolution in With 2.5 million+ bioresorbable device patients treated, ClosureFast design gives device Medtronic states that engineers more efficient the ClosureFast procedure and predictable options,” is the global market leader in said Jason Fant, product manager RFA for the treatment of CVI and has at Zeus. “With a combination of 200+ published clinical studies and unmatched sizing, uniform wall articles. thickness, and tailored absorption A press release details that profiles, Absorv XSE oriented tubing ClosureFast 6Fr builds upon the will allow designers to replace metallic technology’s proven platform. New stents in a wider variety of procedures.” features in the updated ClosureFast RFA catheter include: Updated ClosureFast ● A lower profile 6Fr catheter radiofrequency ablation designed for better flexibility, catheter receives US FDA 510(k) easier navigation, and greater kink clearance for treatment of CVI resistance, even in tortuous veins Medtronic has announced that an ● Increased length of the heating updated ClosureFast radiofrequency element (from 7cm to 8cm) for ablation (RFA) catheter in a lower 6Fr greater procedural efficiency profile is now available in the USA “Offering the ClosureFast catheter following 510(k) clearance from the in a lower 6Fr profile is part of our US Food and Drug Administration commitment to provide meaningful (FDA). The ClosureFast procedure product advancements for patients,” is intended to treat chronic venous said David Moeller, SVP and president insufficiency (CVI). of Peripheral Vascular Health at “For patients with mild tortuosity in Medtronic. “We listened to our their saphenous veins, where I would customers’ feedback to evolve this normally use a wire or two access trusted, market leading technology. The points, I have found that the new new features are designed to provide ClosureFast 6Fr system glides through advantages in technical performance more easily than the 7Fr system, and procedural efficiency.”

International Multidisciplinary Endovascular Forum Florence, 11-13 April 2024 Advancing the world of knowledge

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SCAN ME

November 2023 | Issue 100

30 Market Watch

Industry News Nick West appointed to associate CMO role at Shockwave Medical

Shockwave Medical has announced that Nick West has joined the company in the role of associate chief medical officer (CMO). He will report to current CMO Keith Dawkins, and will be based in Santa Clara (USA) with plans to succeed Dawkins as CMO in mid-2024. “Dr West brings to Shockwave a wealth of expertise in the interventional cardiology space,” said Dawkins. “Having known Nick for many years, I am confident that his expertise will be highly influential in further developing intravascular lithotripsy (IVL) as the standard of care for calcium modification, and will also be a valued asset in the evaluation and development of novel transformational technologies to augment our portfolio in the years to come.” West joins Shockwave from Abbott Vascular, where he served as CMO and divisional vice president of global medical affairs for the past four years. Prior to his time with Abbott, West served as an attending cardiologist at the Royal Papworth Hospital NHS Foundation Trust (Cambridge, UK).

intracoronary imaging/vulnerable plaque detection, and bioresorbable scaffold technology. He is a founding member and CMO of the Cambridge“There is no denying the exceptional based vulnerable plaque startup, job Shockwave has done to generate PlaqueTec, and sits on the Innovation significant momentum behind IVL Council of the UCLA School in a relatively short period of time. of Biodesign. I am extremely excited to utilise West was also a co-author of the everything I have learned from my ILUMIEN IV late-breaking clinical time both in industry trial presented at the and previously as an European Society of interventional cardiologist Cardiology (ESC) congress to help continue to (25–28 August, Amsterdam, propel Shockwave The Netherlands) earlier forward as one of the this year. “His expertise in most innovative players intravascular imaging will in the cardiovascular be especially beneficial space,” said West. “I look to many Shockwave IVL forward to contributing customers as the use of Nick West to the company’s mission imaging continues to of developing exceptional increase, and, as a result, solutions to revolutionise treatments for there arises a greater appreciation underserved patient populations.” for the presence and diverse West graduated in medicine from morphology of cardiovascular Trinity Hall, University of Cambridge calcium,” Dawkins concluded. (Cambridge, UK) and St Thomas’ Hospital Medical School (London, FastWave Medical secures UK) and trained in interventional multi-million dollar private cardiology at the John Radcliffe financing within weeks Hospital (Oxford, UK) and Green Lane FastWave Medical recently announced Hospital (Auckland, New Zealand). He the swift closure of an oversubscribed has published over 170 peer-reviewed multi-million dollar private financing. papers and book chapters on topics A press release states that this including vascular biology, coronary achievement, secured in just a few physiology/microvascular function, weeks, highlights the growing interest

and confidence in FastWave’s ability to execute its vision for the development of multiple intravascular lithotripsy (IVL) systems. Scott Nelson, co-founder and CEO of FastWave Medical, commented: “This financial milestone, combined with the speed at which our engineering team is moving, underscores FastWave’s momentum in the IVL space.” FastWave Medical details that its journey began just two and a half years ago with a clear vision: to address the challenges of artery calcification, a significant predictor of adverse cardiac events, through differentiated IVL platforms. An ageing global population that calls for effective and minimally invasive solutions has never been higher. FastWave’s charge to this cause has led to the development of multiple IVL systems, providing physicians with more treatment options that are economical and easy to use. Arthur Lee, an interventional cardiologist at The Cardiac & Vascular Institute (Gainesville, USA) and advisor with High Circle Ventures, shared: “IVL is an impressive therapy and FastWave’s team is moving remarkably quickly. Their inventive IVL systems promise to fill muchneeded gaps with existing technologies and I am excited about the prospects of treating my patients with FastWave’s devices.”

22–24 November The Vascular Societies’ Annual Scientific Meeting Dublin, Ireland

3–6 March VENOUS2024 (American Venous Forum annual meeting) Tampa, USA

28–31 May Leipzig Interventional Course (LINC) Leipzig, Germany

1–3 December 20th European Angiology Days Online

14–16 March IM Endo Forum - International Multidisciplinary Endovascular Forum Edition Florence, Italy

19–22 June Vascular Annual Meeting (VAM24) Chicago, USA

Conference calendar 29 October–2 November The VEINS (Venous Endovascular Interventional Strategies) and VIVA (Vascular Interventional Advances) Las Vegas, USA viva-foundation.org/future-meetings

8–10 November Paris Vascular Insights (PVI) Paris, France paris-vascular-insights.com

14–18 November VEITHsymposium New York, USA

veithsymposium.org/index.php

vascularsociety.org.uk

europeanangiologydays.net

2024 3–5 March 27th European Vascular Course Maastricht, The Netherlands vascular-course.com

venousforum.org/education/annual-meeting/

imendoforum.com

23–25 April Charing Cross (CX) Symposium London, UK cxsymposium.com

leipzig-interventional-course.com/visitors/ linc-2024/

vascular.org/2024-vascular-annual-meeting

20–22 June 24th European Venous Forum (EVF) Annual Meeting Versailles, France europeanvenousforum.org

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