Venous News 16 – October 2023 US Edition

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OCTOBER 2023 / Issue 16

Featured in this issue:

5 Adoption

9 Alejandro Gonzalez

Erin Murphy

Venous disease as a health problem in Mexico

of new techniques

Ochoa

The difficulties of moving from page to practice

By Jocelyn Hudson

Following the recent publication of new multisociety guidelines on varicose vein management, a debate at the International Union of Phlebology (UIP) 2023 World Congress (Sept. 17–21) in Miami highlighted the need to focus on implementation of guidelines and on translating the written word into day-to-day venous practice.

T

he 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 following topics: Evidence supporting the prevention and management of varicose vein patients with compression; treatment with drugs and nutritional supplements; evaluation and treatment of varicose tributaries; superficial venous aneurysms; and the management of complications of varicose veins and their treatment.

The publication—authored by Peter Gloviczki, MD, of the Mayo Clinic in Rochester, Minnesota, and 19 other

members of a multispecialty guideline writing committee—follows last year’s release of part one of the guidelines, which addressed duplex scanning and treatment of superficial truncal reflux.

Speaking with Venous News, Gloviczki shared a key message from these new guidelines: “Patients need their duplex performed standing up rather than in a supine position”. This, he explained, avoids many false positives and unnecessary varicose vein procedures.

In the introduction to their JVSVL paper, Gloviczki and colleagues outline the reason behind the two-part publication of the updated guidelines.

They note that all recommendations in part one were based on a new,

“Of special value [in these new guidelines] is the list of projects for future research.”

10 Profile

15 Multimodal imaging

Stephen Black

independent systematic review and meta-analysis that “provided the latest scientific evidence to support updated or completely new guidelines on evaluation with duplex scanning and on the management of superficial truncal reflux in patients with varicose veins”. However, the authors recognised “several additional important clinical issues” needed to be addressed, despite many having varying levels of scientific evidence associated with them. For this reason, when a systematic review was not available, the writing committee based ungraded statements on a comprehensive review of the literature, combined with unanimous consensus of the expert panel.

Alongside various recommendations, the writing committee highlight “several” knowledge gaps on the natural history, evaluation, prevention and treatment of patients with varicose veins, underscoring their top 20 recommendations for future research. The three they identify as the most important are comparative studies of polidocanol endovenous microfoam versus physician-compounded foam for treatment of varicose tributaries, comparative studies of polidocanol endovenous microfoam versus other techniques of thermal and non-thermal ablation of incompetent superficial truncal veins, and the best metric of axial reflux to determine ablation of superficial truncal veins.

Gloviczki told Venous News: “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 emphasizes 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

Efthymios Avgerinos

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.

GREENHALGH, 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’ 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’.

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 Continued on page 4

Continued on page 2

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October 2023 / Issue 16

Cover Story

The difficulties of moving from page to practice Continued from page 1

thrombophlebitis, bleeding varicose veins and treatment of superficial venous aneurysms. Of special value is the list of projects for future research.”

Worth the effort?

At UIP 2023, the question of whether societal guidelines are “worth the effort” was addressed in a debate.

According to Mark Meissner, MD, of the University of Washington in Seattle, the answer is “undoubtedly yes”.

He started by referencing the new SVS, AVF and AVLS guidelines as a feat to be recognised in and of itself, submitting to the audience that “whether you believe this is worth the effort or not, just getting three societies together to agree on a set of guidelines with multidisciplinary involvement— from vascular surgeons, interventional radiologists, venous and lymphatic medicine specialists, and vascular medicine specialists—probably the broadest group ever brought together to do any guidelines for any vascular technology there is, that is worth the effort to just bring everybody to the same page”.

Meissner first addressed the question of ‘effort’ from a monetary standpoint.

He remarked that the multisociety varicose vein guidelines represented excellent value for what they provide for venous specialists. These guidelines “weren’t just off the cuff [...] but they were based on a very thorough systematic review of the literature,” he said.

Getting to the crux of his argument, Meissner stressed that busy clinicians do not have the time to conduct an “exhaustive review of every clinical question there is”. Guidelines fill that gap. They provide a “great benefit” and are “very much worth the effort for the busy, practicing physician who doesn’t have the time to review every bit of evidence on the entire spectrum of varicose veins,” Meissner argued.

In addition to this, he highlighted the difficulties for the average physician of determining which evidence is applicable to which patient. “[The SVS,

AVF and AVLS] guidelines include a grade assessment of generalisability and precision for each of these recommendations that help you decide,” he said. “They’re not telling you that you have to decide in a certain way, but help you decide what to do for your patient in your practice.”

Finally, he stressed a key point: “We do need defined standards to demonstrate most of us are not outliers, and it’s very much better for us as societies and medical professionals to decide what is appropriate care.” If societies do not publish guidelines, he warned, “somebody else is going to do it for us”.

Meissner concluded by reiterating his opinion that societal guidelines are worth the effort, citing that the costs are “not that much” overall, especially when taken alongside the “immeasurable” benefit to clinicians. “[Guidelines are] the only place where you get a concise summary of the evidence out there, and you get guidance on how you apply that to

your practice,” he said. “This isn’t just putting a bunch of literature in front of you and saying ‘figure out what to do with it’, it tells you how you should apply this, realising there’s lots of room for clinical judgment and patient preferences.”

Putting forward the opposing view, Alun Davies, FRCS, of Imperial College London in London, England, argued instead that societal guidelines are “probably not worth the effort”.

According to Davies, one of the things that is wrong with societal guidelines is that clinicians “act as judge and jury”. There are many other stakeholders to consider, the presenter stressed.

He said that patients should be involved in the development of guidelines, for instance, as should industry, politicians, and payors.

“Really, societies are a very small, biased group of people who are putting these guidelines together,” he remarked.

In light of this, the presenter asked: “Who are these guidelines of benefit for? Are they for political reasons for a medical society? Are they really for the payors? Or do they give some legal protection?”

Implementation a key issue

Peter Gloviczki

“These up-to-date, evidence-based recommendations are made by a 20-member multidisciplinary expert panel of three leading North American societies.”

One of Davies’ main points, however, was to do with the issues surrounding implementation of societal guidelines.

“How do we get people to actually go and implement the guidelines?” he asked. Here, the presenter referenced the failure of guidelines for venous leg ulceration to be translated into practice, despite the sheer number of recommendations available. “There are more guidelines written by more organizations about venous leg ulceration than I care to think about,” he quipped.

Despite their differences in opinion, Meissner agreed with Davies that implementation of societal guidelines “is a problem”. He explained: “We put these guidelines out there and I think the grading criteria is very applicable to how to use them in your practice, but we don’t spend enough time teaching people how to interpret these levels of evidence and these recommendations, because I think that’s what’s really helpful to people in their practice.”

LATEST NEWS THE STORIES IN BRIEF FROM THE VENOUS WORLD

n PERCEPTION OF VENOUS DISEASE: The majority of respondents indicated that venous work might over 300 vascular be less “valued” than arterial work in the field surgeons who of vascular surgery responded to a recent survey indicated that they perceive the management of venous disease to be of less value than that of arterial disease.

Investigators Misaki M. Kiguchi, MD, of MedStar Washington Hospital Center in Washington, DC, and colleagues share this and other key findings in the Journal of Vascular Surgery: Venous and Lymphatic Disorders.

74.3% of 315

For more on this story go to page 5. n LYMPHEDEMA: Lymphedema patients feel “dissatisfied”, “let-down” and “neglected” by the U.S. healthcare system. This is the finding of a survey answered by nearly 2,000 patients, presented by Stanley Almost 90% G. Rockson, report never being tested MD, of Stanford for early 90% detection of University School lymphedema of Medicine in Stanford, California, at the International Union of Phlebology (UIP) World Congress (Sept. 17–21) in Miami.

For more on this story go to page 6. n STENT PLACEMENT IN NIVL PATIENTS: Parameters for patient selection are “poorly defined” for the treatment of nonthrombotic iliac vein lesions (NIVL), Kush Desai, MD, of Northwestern University in Chicago, told delegates at UIP 2023.

Failures following stent placement beg the question: was the stent necessary?

“NIVL is not a disease of mortality, it is a disease of quality of life.”

For more on this story go to page 16.

Editors-in-chief: Stephen Black, Manjit Gohel and Erin Murphy | Publisher: Stephen Greenhalgh | Content Director: Urmila Kerslake Head of Global News: Sean Langer | Editor: Jocelyn Hudson Jocelyn@bibamedical.com | Editorial contribution: Jamie Bell, Bryan Kay and Suzie Marshall Design: Terry Hawes and Wes Mitchell Advertising: sales@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: Print Tech Solutions. 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.

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October 2023 / Issue 16

Obituary

OBITUARY

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

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’ 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 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 hyperlipidemia when he was a 1 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 rigor of prospective randomized 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. The 15-year followup of the EVAR 1 and 2 trials were published in The Lancet in 2016. Greenhalgh was also the principal investigator of the Mild to moderate intermittent claudication (MIMIC) trials.

Inspired by the impact of these many landmark trials, Andrew W Bradbury, Sampson Gamgee Professor of Vascular Surgery, University of Birmingham, England, and principal investigator of the randomized controlled BASIL trials, wrote to Greenhalgh: “Your achievements are greater than anyone alive or dead.” 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 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 Charing Cross (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. 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.

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. In the days before his passing, Greenhalgh’s passion for the quality of the CX 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.

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 Greenhalgh wrote the constitution. He was founder and chairman of the editorial board for

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1. P rincess Anne attends the CX Symposium in 1982 2. M ichael DeBakey (far left), Karin Greenhalgh and Roger Greenhalgh in 1989 3. G reenhalgh operating 4. G reenhalgh receiving the first Living Legend or International Lifetime Achievement Award from the Society for Vascular Surgery (SVS) in 2018 from Enrico Ascher

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 Greenhalgh as Honorary Life President in recognition of his founding role.

His 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 H Bush to London in 1991. More recently, Greenhalgh became

a company director, founding BIBA Medical with his son, Stephen, in 1994. Greenhalgh was editor-inchief 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.

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. Writing in EJVES following Greenhalgh’s receipt of this award, his long-time research partner, Professor Janet Powell of Imperial College London hailed him as a “legendary figure” whose wit, humour and charm “have made him many friends across the world”.

The editors-in-chief of Venous News have also reflected on Greenhalgh’s legacy. Erin Murphy, of Atrium Health’s Sanger Heart and Vascular Institute in Charlotte, North Carolina, shared: “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. Through 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 am honored 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.”

Stephen Black, of King’s College London and Guy’and St Thomas’ Hospital, remarked: “Roger’s influence will be felt long after his passing. He has shaped the direction of vascular surgery through pivotal studies, seminal meetings and the establishment of the premier vascular journal, the EJVES. It was my pleasure to work with him at CX over the last several years and learn from him during that time.”

Manjit Gohel, of Cambridge University Hospitals in Cambridge, England, and Imperial College London, said: “It is difficult to put into words the enormous positive impact that Roger has had on the field of vascular surgery. His achievements in clinical trials, supporting education and promoting science through CX have laid the foundation for the next generation. It has been an honour working with Roger over the last few years with the CX meeting—his dedication was incredible; his sharp and quick-witted mind always impressive. He leaves a tremendous legacy and friends around the world.”

Professor Roger Greenhalgh, MA MD MChir FRCS, was married to Karin Maria (née Gross)— who died in April 2020 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.

Issue 16 / October 2023

New Techniques

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, MD, of Atrium Health’s Sanger Heart and Vascular Institute in Charlotte, North Carolina, posed this question to attendees of the International Union of Phlebology (UIP) World Congress (Sept. 17–21) in Miami. She identified clinical need, having a product that is perceived as better, and creating an enabling environment to facilitate adoption as the three main conditions that influence the pace and possibility of an innovation becoming widely used.

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,

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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 emphasized: “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,

“It is imperative to have knowledge of the field and confidence in how your product adds to it.”

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 new innovation to gain universal traction, it’s 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 utilized in rural areas,” Murphy reminisced. “However, how many of you in the audience initially dismissed the idea of virtual visits, thinking, ‘I am never going to do that’? I distinctly recall having that reaction.”

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,” Erin Murphy said, referring to her list of conditions Murphy that influence adoption of a novel technique.

by investigating the factors that female respondents were “significantly” that venous work might be less Survey suggests this, influence vascular surgeons’ current younger than their male counterparts “valued” than arterial work in the field perceptions of superficial and deep (p<0.0001). In addition, they had fewer of vascular surgery. On multivariable venous work venous disease treatments. years in practice (p<0.0001) and were regression, they detail, the predictors Kiguchi et al share that an anonymous more likely to perceive a gender bias for the perception of venous work being less valued survey was distributed electronically within a career encompassing venous less valued were female gender (odds to practicing vascular surgeons in disease compared with the male ratio 2.01, 95% confidence interval than arterial December 2021, with respondents respondents (p=0.02).

1.14–4.03) and completion of a vascular stratified by gender and practice Of the 315 participants in the survey, surgery fellowship (odds ratio 2, 95% interventions breakdown. They detail that a venousKiguchi et al relay that 143 confidence interval 1.15–3.57). heavy practice was defined as one with (45.4%) had a venousIn their conclusion,

The majority of more than 300 vascular surgeons who responded to a recent survey indicated that they perceive the management of venous disease to be of less value than that of arterial disease.

Investigators Misaki M. Kiguchi, MD, of MedStar Washington Hospital Center in Washington, DC, and colleagues share this and other key findings in the Journal of Vascular Surgery: Venous and Lymphatic Disorders.

BY WAY OF BACKGROUND TO their study, the authors note that biases and gender disparities influence career pathways in medicine, with vascular surgery being no exception. They continue that, despite venous disease comprising an estimated 1–3% of total healthcare expenditures, its value among vascular surgeons is ill defined. It was the aim of the present study to address

venous work comprising ≥25% of the total volume.

The investigators note that a total of 315 practicing vascular surgeons responded to their survey, with a majority of 81.5% from the USA. The respondents had a mean age of 46.6±9.6 years, the authors detail, and almost two-thirds (63.3%) identified as men.

In terms of race and ethnicity, Kiguchi and colleagues state that 63% of respondents identified as White (nonHispanic), 17.1% Asian or Asian Indian, 8.4% Hispanic, Latinx, or Spanish, 1.6% Black. The remaining 9.9% selected ‘unknown’ for this category.

Nearly half of respondents (47%) shared that their practice setting was academic, compared to 26.5% private practice, 23.3% hospital employed, and 3.2% ‘other’.

The investigators also note that the

heavy practice, with Kiguchi et al state that no differences found vascular surgeons in age or gender perceived the between the management of venous-heavy venous disease respondents perceived and venous-light to be of less venous work to be less practices. They value than that of “valued” than arterial continue that those arterial disease, work in the field of with a venousparticularly vascular surgery heavy practice by women and had significantly fellowship-trained more years in practice vascular surgeons. statistically (p=0.02), had “The prevalence of sought more venous training venous disease, as measured after graduation (p<0.0001), were by its proportion of the U.S. healthcare more likely to be in private practice budget, cannot be overstated,” the (p<0.0001), and were more likely to authors state. As a result, they stress desire a practice change (p=0.001) that “efforts to elevate the importance compared with those with a venousof chronic venous disease within the light practice. scope of vascular surgery practices are Kiguchi and colleagues report that, essential to ensure patients are provided overall, 74.3% of respondents indicated with appropriate specialty care.”

74.3% of 315

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October 2023 / Issue 16

UIP 2023

Let down and neglected: First formal attempts to quantify lymphedema patient dissatisfaction Lymphedema patients feel “dissatisfied”, “let-down” and “neglected” by the U.S. healthcare system—meaning there is an urgent need for reform in physician education.

This is the finding of a survey answered by nearly 2,000 lymphedema patients, the first formal attempt to quantify lymphedema patient dissatisfaction, presented by Stanley G Rockson, MD, of Stanford University School of Medicine in Stanford, California, at UIP 2023.

GIVEN THAT PATIENTS WITH lymphedema often encounter “a lack of awareness and general lymphatic ignorance within the healthcare system”, Rockson calls on the venous community to implement a nationwide postgraduate education program for U.S. doctors, in conjunction with the Center for Disease Control and Prevention (CDC).

He asks large societies—such as the

American Academy of Family Practice, by a specialist outside of the expected the American College of Surgeons, and authorities (cancer surgeons, radiation the American Heart Association—to oncologists, primary care physicians). “embrace this problem” and disseminate “There was a substantial percentage the education program, once developed, of this subgroup that never received through their channels. a diagnosis from a physician,” Rockson and colleagues sent out a says Rockson.

23-item online questionnaire to selfIn the LE&RN registry, identified lymphedema patients. This approximately 30% of patients were focused on healthcare interactions diagnosed by a family physician, an and patient experiences within the internist, or a doctor of osteopathy. medical system; 1,805 participants fully Frequently, a physical therapist made completed the survey. the diagnosis. Rockson underscores To validate this anonymously derived the fact that “while they have a great questionnaire data, the investigators also deal of experience with intervention conducted a comparative analysis of 529 for lymphedema, they are not actually patients from the Lymphatic Education credentialled to deliver diagnosis—and & Research Network (LE&RN) registry yet that is where a substantial number of to compare findings from the two those diagnoses emanate”. datasets and to collect information He summarizes: “Patients do feel on demographic and clinical generally neglected by the healthcare characteristics. environment. We, as healthcare The average score for professionals, let them down Almost 90% patient satisfaction with and they are not completely report never lymphedema diagnosis satisfied with their being tested and treatment, on a interactions and the for early scale of zero to 10, is % delays in their receipt detection of two. The mean distress of care.” lymphedema rating for lymphedema Over half is “moderately high”, at the questionnaire almost 50 out of 100, and respondents had cancer-related patient satisfaction with their lymphedema. Prior to cancer physician is “modest” (approximately treatment, two thirds of these patients 60% report being satisfied). report not receiving any educational The vast majority of patients (almost materials on lymphedema, and 86% 90%) report never being tested for early say they had no discussion with their detection of lymphedema. Of those healthcare provider about the threat that were tested, half were diagnosed of lymphedema.

Patient selection critical for cyanoacrylate treatment of chronic venous insufficiency Cyanoacrylate is an innovative treatment for saphenous reflux—but, like all treatments, patient selection is critical for success. Kathleen Gibson, MD, of Lake Washington Vascular Surgeons in Bellevue, Washington, told delegates how to safely use this treatment modality at the International Union of Phlebology (UIP) World Congress (Sept. 17–21) in Miami, offering advice on how to identify the ideal patient for this technique.

“WHEN THIS [TECHNIQUE] FIRST CAME out, I thought it would be great for my young, healthy, active patients who do not want to wear stockings and want to return to normal activities, such as working out, right away,” Gibson admitted, before suggesting that over time she now thinks that geriatric patients may have more to benefit from cyanoacrylate. “Those [fit, young] patients do well no matter what you do”, she continued. “The group that sees the most benefit from this technology is, for example, an elderly patient with limited mobility, perhaps on blood thinners, with difficulty putting on stockings. You need to get these geriatric patients ambulatory right away.”

There are several considerations doctors must account for when weighing up whether to use cyanoacrylate. This is particularly true for elderly patients with limited mobility and who may have thin skin, a low tolerance for tumescence, or advanced disease. Performing the least invasive procedure

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possible, Gibson noted, is often best for patients with this profile. She also noted that outcomes for obese patients in her experience were “really good” with cyanoacrylate, though she did not show data for this in her presentation.

According to Gibson, patients who are unsuitable for this treatment are those with: ◆ I nappropriate anatomy: veins that are too tortuous, truncal veins that are too short or too superficial ◆A history of adhesive or cyanoacrylate allergy, skin sensitivities, and/or atopic dermatitis ◆A preference for a traditional technique ◆D iscomfort with the idea of a permanent implant ◆N o insurance coverage for the technology and/ or for whom self-pay would be a financial hardship—there are other options Gibson also pointed out that the procedure needs to be performed by the right doctor. The specialist best suited to using cyanoacrylate, according to the speaker, understands superficial venous disease, has good training in ultrasound and anatomy, has experience of gaining venous access and achieving venous closure with radiofrequency or endothermal techniques, and has good judgment to select the right patient.

Positioning adhesives such as the VenaSeal closure system (Medtronic) as the modern treatment for saphenous reflux, Gibson gave a brief history of treatment options for chronic venous insufficiency.

From surgical treatment in the 1860s to medical compression stockings in the 1950s, interventionists developed radiofrequency ablation (RFA) in the 1990s.

In the 2000s, endovenous laser ablation (EVLA) and sclerotherapy both gained prominence, before adhesives entered the venous scene in 2015.

“Whenever you have something new you have a learning curve”, Gibson explained. “So how can we improve upon these historical techniques?”.

Eliminating the need for tumescent

The majority (90%) of cancer-related lymphedema patients also report not being given compression ahead of the initiation of cancer treatment.

During treatment for cancer, almost 80% of patients report never being questioned about lymphedema symptoms nor being examined for this condition, despite the fact surveillance techniques to detect stage 0 lymphedema are commercially available.

Patients with non-cancer-related lymphedema appear even more overlooked. The impact of lymphedema on quality of life, the delay in diagnosis from symptom onset, and the number of doctors consulted prior to diagnosis were all greater for patients with noncancer-related lymphedema than for patients with lymphedema related to cancer.

“The net result of all these data is to say that at every point of patient engagement within the healthcare environment, we have the opportunity to do better,” concludes Rockson. “From pretreatment education to pre-emptive treatment, to peritreatment symptom assessment, detection, testing and, eventually, diagnosis, referral, treatment patterns and sustained self-management.

All of these can be improved, and we hope that this subjectively derived data will help us [to achieve this].”

He urges that research and reform are needed to optimize lymphatic healthcare education and delivery within the U.S. medical system.

anesthesia—as in cyanoacrylate—would be one way of improving chronic venous insufficiency treatment, in Gibson’s view. “In expert hands it works great”, she opined, “but it is not appropriate for all patients.”

Evidence from the largest randomized vein trial ever done will inform future cyanoacrylate practice.

With the results due to be published in 2024, the VenaSeal Spectrum program is a post-market clinical study of the VenaSeal system compared to current standards of care. It consists of three distinct studies.

One compares the effectiveness of VenaSeal to that of endothermal ablation, using the results of a venous treatment satisfaction questionnaire at 30 days and the elimination of truncal reflux at index procedure as primary endpoints. A second evaluates VenaSeal versus surgical stripping, using the same primary endpoints. The third study investigates the effectiveness of VenaSeal in treating venous leg ulcers, using time to ulcer healing through 12 months as the primary endpoint. “These studies should give us more of an idea about provider experience and patient experience”, Gibson said. Alongside Manjit Gohel, MD (Cambridge University Hospitals, Cambridge; Imperial College London, London, England), Gibson is the global principal investigator of the VenaSeal Spectrum program.

A previous postmarket evaluation of VenaSeal, the WAVES trial, found that, at one month, 100% of the treated veins remained closed, quality-of-life scores improved significantly, and return to work and normal activity times were short.

“Whenever you have something new you have a learning curve.”

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8

October 2023 / Issue 16

Ablation

‘Good’ long-term results for radiofrequency ablation of saphenous veins Five years on from radiofrequency ablation (RFA) of saphenous veins, reoperation rates were low, incidences of nerve injury were minimal, and any postoperative occurrences could be identified early.

In a rare report of long-term results of RFA in Japan, Hitoshi Kusagawa, MD, PhD, of Matsusaka Ohta Clinic in Matsusaka-shi, Japan, presented these positive outcomes at the International Union of Phlebology (UIP) World Congress (Sept. 17–21) in Miami.

IN JAPAN, INSURANCE COVERAGE FOR RFA began in 2014. There have been many reports that the early results were excellent, but the longterm results have rarely been reported. The study investigators therefore set out to examine results up to five years after RFA—which was the only means of endovascular treatment at Kusagawa’s facility—and to evaluate recurrent varices after surgery (REVAS), reoperation (REDO), and complications.

Kusagawa and colleagues looked at 275 consecutive RFA cases (83 men, 192 women; age 67.5±10 years), where 354 veins (290 great saphenous vein and 64 short saphenous vein) were treated in 350 limbs. The interventionalists performed postoperative followup three days, one week, one month, and six months following treatment. Patients with residual lesions were followed up every six months thereafter.

Five years after RFA, the doctors interviewed these patients over the phone about reoperation, recurrence, and neuropathy, excluding those who died from other diseases. During this five-year follow-up, the

Femoral nerve blockade ‘might be beneficial’ for cetain patients undergoing endovenous laser ablation According to the results of a recently published single-center, randomized controlled trial, femoral nerve blockade “seems to decrease pain” during endovenous laser ablation (EVLA) combined with local phlebectomy.

Researchers suggest, therefore, that it “might be beneficial” for patients undergoing extensive local phlebectomies and those sensitive to pain during EVLA. AUTHORS ONERVA Hurmerinta-Kurkijärvi, MD, of the University of Helsinki in Finland, and colleagues begin by noting that EVLA using tumescent anesthesia for treatment of an insufficient great saphenous vein (GSV) can be painful and require intravenous pain management or, occasionally, sedation with propofol.

Femoral nerve blockade, the authors write, anesthetizes the femoral nerve distribution and is usually used for

investigators collected data on 327 veins. Of these, 223 veins (63%; 180 great saphenous vein, 43 short saphenous vein) underwent ultrasound examination.

Positive results

The occlusion rate after five years was 98.9% for great saphenous veins and 95.3% for small saphenous veins. This is favorable when compared with the occlusion rates in the published literature; Kusagawa listed his team’s findings alongside those of four other venous RFA studies, which reported occlusion rates of 85.2%, 93.1%, 94.2%, and 94.9%, respectively.

“Only” one recanalized vein was symptomatic and underwent retreatment. After great saphenous vein RFA, Kusagawa reported 80% of accessory saphenous veins were retained at five years, with persistent blood flow.

The five-year results after RFA were “generally good”, according to the speaker. Neuropathy occurred in 6.3% of cases, mainly in the great saphenous vein fulllength ablation cases, and 41% of them disappeared completely between six months and five years after RFA. There were no new cases of neuropathy within the five-year follow-up period, and all patients had reported “no problems” in daily life.

Endovenous heat-induced thrombus grade >2 RFA of saphenous veins gaining occurred in 5.9% of cases (6.6% of great saphenous popularity in Japan veins, 3.1% of small saphenous veins) and Nowadays, minimally invasive methods are regressed within one month in all cases with increasingly growing in popularity for the treatment anticoagulant therapy. of saphenous veins. As a standard surgery for varicose Incompetent perforator veins (IPVs) played the most veins of the great saphenous vein type, endovenous important role in reoperation cases by REVAS after ablation is deployed instead of the traditional RFA of saphenous veins, Kusagawa conveyed. The stripping—and Kusagawa pointed out that in most reoperation rate up to five years after RFA Western guidelines for the treatment, ablation was 10.7% (great saphenous vein 9.7%, has a higher recommendation level than small saphenous vein 15.6%). In traditional stripping due to its good the reoperation cases after great initial results. This is not the case in Kusagawa and saphenous vein RFA, the sites of Japan—yet, at least. colleagues looked reflux were 14 IPVs, seven deep RFA comprises a minimally at 275 consecutive venous junction-related, and six invasive technique for efficiently distal great saphenous veins. In treating venous reflux with minimal RFA cases (83 cases after small saphenous vein discomfort to the patient. One of the men, 192 women; RFA, there were five IPVs and main advantages of the technique, age 67.5±10 years) three isolated branch varices. as described by Octavian Andreou, The majority of postoperative MD, of the University of Medicine recurrences could be identified and Pharmacy in Cluj-Napoca, Romania, by follow-up to six months: the time et al in a 2023 comparative retrospective of diagnosis of recurrence by ultrasound study of RFA for the treatment of chronic examination was within six months of regular followinsufficiency of the saphenous vein, is that up in 61% of great saphenous veins and 79% of small it can be performed on an outpatient basis using saphenous veins. local anesthesia.

anterior thigh and knee procedures.

They state that it is straightforward to inject with ultrasound guidance because the nerve is easy to visualize in the groin.

Against this backdrop, the authors share that it was their aim in a doubleblind, randomized controlled trial to determine whether femoral nerve blockade before tumescent anesthesia decreases the pain of GSV EVLA combined with local phlebectomy.

Writing in the Journal of Vascular Surgery: Venous and Lymphatic Disorders, Hurmerinta-Kurkijärvi and colleagues detail that 80 patients who underwent GSV EVLA combined with local phlebectomy under tumescent anesthesia were randomized into two groups: placebo (control) and femoral nerve blockade (intervention). In the former, 40 patients were given placebo femoral nerve blockade with 0.9% saline before tumescent injection; in the latter, the same number of patients received 1% lidocaine with adrenaline for femoral nerve blockade before tumescent injection. The investigators specify that only the study nurse—who performed the randomization—knew which patients were in which group, while the patients and operating surgeon were unaware of the randomization group.

In the methods section of their paper, Hurmerinta-Kurkijärvi et al explain that the effectiveness of anesthesia was tested 10 minutes after injection

using the pin-prick test and a numeric rating scale (NRS). This scale was completed before and during tumescent anesthesia and during EVLA ablation and local phlebectomy, the authors note.

Furthermore, they share that the motor function of the femoral nerve was tested at the end of the procedure, and one hour, after using the Bromage method.

The authors report that the median NRS score for pain during tumescent injection around the GSV was two (interquartile range [IQR] 1–4) in the placebo group compared with one (IQR 1–3) in the femoral nerve blockade group. They found that very little pain was experienced during laser ablation, with the median NRS score being zero (IQR 0–0) and zero (0–0.75) in the placebo and femoral nerve blockade groups, respectively.

The most painful stage was injection of tumescence to the local phlebectomy

“No indication for routine use of femoral nerve blockade is indicated.”

sites in both groups, HurmerintaKurkijärvi et al communicate. They share that the median NRS score was four (IQR 3–7) in the placebo group and two (IQR 1–4) in the femoral nerve blockade group (p=0.01).

Finally, the investigators relay that, during local phlebectomy, the NRS score was two (IQR 0–4) versus one (IQR 0–3) in the placebo and femoral nerve blockade groups, respectively.

“Only the difference in pain during injection of tumescence before local phlebectomy was significant,” the authors write.

Hurmerinta-Kurkijärvi and colleagues summarize that femoral nerve blockade “seems to decrease pain” during EVLA combined with local phlebectomy, adding that patients experienced the highest pain when tumescence was injected before local phlebectomy. In addition, those in the femoral nerve blockade group experienced “significantly less pain” than the placebo group.

“No indication for routine use of femoral nerve blockade is indicated,” the authors conclude. However, they state that “it could be used to decrease the pain for patients who experienced strong pain during varicose vein surgery, especially if extensive local phlebectomies are required”.

Issue 16 / October 2023

Opinion

POINT OF VIEW

Venous disease as a health problem in Mexico ALEJANDRO GONZALEZ OCHOA Alejandro Gonzalez Ochoa, MD, gives an overview of how Mexico addresses the “predominant” problem of chronic venous disease (CVD) in the country, and suggests ways in which improvements can be made.

C

VD is a widespread and frequently underestimated condition that entails a broad spectrum of venous abnormalities. It creates a massive global burden for treatment and care, consuming approximately 2% of national healthcare budgets, and the problem is worsening. The literature shows a varicose vein incidence rate of 4–5% over two years and disease progression rates of 4% in a growing population of older adults with a tendency to obesity.1 Even in patients who have had their varicose veins removed, nearly half experience clinical recurrence or progression at five years.2 Mexico suffers these same CVD burdens and faces them against a backdrop of complex challenges.

Mexico is the 16th biggest country in the world with a population of 120–130 million3 and a demographic make-up that is socially, culturally, and economically heterogeneous, where CVD (CEAP C1–C6) has a prevalence of 71.3% and chronic venous insufficiency (CEAP C3–C6) of 25%.4 This enormous number of total patients is problematic for Mexico’s healthcare system, despite being the 14th biggest economy in the world.

Mexico also has 25 million people living in rural areas, where significant economic and cultural gaps persist when compared to the urban population.

This is directly reflected in the level of healthcare coverage, particularly for CVD, with the number of vascular specialists limited to roughly one for every 130,000 inhabitants.

Mexico is a country with deep spiritual beliefs that are reflected in medicine, with patients preferring treatment with natural-holistic remedies, and since CVD in the early stages can be uncomfortable but not incapacitating, there is a culture favoring medical advice from family members, friends, social media, or pharmacists, rather than primary care physicians from public healthcare, whom they actually try to avoid, allowing CVD to slowly progress

to severe stages.

Economics plays a key role in CVD treatment and care. Only 3–7% of the population has access to private health insurance or can afford to pay from their own pocket. These patients usually have direct access to a vascular specialist with same-day ultrasound MEXICO FACTS

with only 16.8% of patients with CVD being considered for vascular referral, even some with higher CEAP stages.4 Due to the high demand and limited availability of vascular specialists, the general surgeon is usually responsible for treating less complicated cases of venous disorders and is usually a second filter for patient referral.

Access to venous ultrasound can also be challenging in most GH networks since the service is not exclusive to the vascular department, dealing with appointment delays for weeks if not months, not to mention CT or MRI availability. Also, the radiologist may not be familiar with specialized venous mapping or reporting. Another problem is the low compliance of the patient at referral. Of 924 patients referred by primary physicians to a specialist, only 172 (18.6 %) complied.4 This is a reflection of patients who would rather continue juggling their symptoms than get through the ordeal that is the bureaucratic process—the long referral time for an appointment, logistic issues with an out-of-town referral, six-to-10-hour bus trips, no financial support for food and transport for the additional necessary companion. All of thsese factors can lead to nonreimbursed missed workdays, since some workplaces will not pay unless three consecutive days are justified Demographic make-up:

Socially, culturally, and economically heterogeneous where CVD has a prevalence of Size:

71.3 %

country 16 th biggest in the word

and chronic venous insufficeiency of

Population:

120–130 million evaluation, computed tomography (CT) or magnetic resonance imaging (MRI) within 24 hours, and elective surgical procedures scheduled within 72 hours. On the other hand, in the government healthcare (GH) network, which is responsible for covering 71% (88 million) of Mexicans,3 things get tricky, when entitlement to coverage does not account for the quality or availability of medical attention.

GH coverage eligibility stems from employment status, depending on whether a beneficiary works in the public or private sector. These services are provided through five different institutions, each with limited and independent budgets.5 In GH services, triage plays a significant role in managing the high demand for services, where patients have no direct access to vascular specialists. A referral is usually not authorized for patients in the lower CEAP category, and the primary physician evaluates according to progression or unless very symptomatic,

25 % “Due to the high demand and limited availability of vascular specialists, the general surgeon is usually responsible for treating less complicated cases of venous disorders and is usually a second filter for patient referral.” for medical reasons. Additionally, when a patient needs evaluation for a more complex treatment, the referral can take weeks or months. All the above problems affecting referral are worsening due to the growing desertion

9

of vascular specialists from GH networks to private practice.

The general approach to CVD treatment in Mexico may differ from other countries. Venoactive medications are widely accepted, and 90% of primary physicians will prescribe them before elastic compression.6 General lifestyle changes are recommended but usually with poor compliance.

Sclerotherapy is very affordable and broadly used as the primary treatment for varicose veins, but not for truncal saphenous vein reflux, and is usually not available in GH practice. An allin-one procedure is preferred over a staging treatment. Patients expect not only a functional benefit but also a cosmetic one. Thermal ablation is mostly a hospital-based procedure under regional anesthesia but is not available in most GH hospitals where open surgery is still the most frequent procedure for saphenous vein reflux treatment. GH does not usually cover home wound healing care or compression stockings.

An increasing disparity of resources between the private and public sectors pushes physicians and patients to be a bit more creative. Trying a hybrid approach for CVD care, patients get an initial evaluation in the private sector and, when necessary, continue care at a GH network. Although it can be a bureaucratic ordeal and not all GH hospitals allow it, patients commonly offer to cover additional supplies or equipment rental, physicians use their own surgical instruments or portable equipment, and refurbishing supplies as much as possible occurs frequently, but always with the goal of offering the patients the best clinical outcome.

In summary, CVD is a predominant problem in Mexico that has a significant impact on both afflicted individuals and the healthcare system. More efforts are warranted from the medical community to review healthcare policies and work with government officials to find an answer to the global CVD conundrum of determining the proper clinical stage for maximizing the allocation of already limited resources for treatment and care.

Alejandro Gonzalez Ochoa, MD, is a vascular surgeon at the Hospital General de Zona No12, Instituto Mexicano Seguro Social, in San Luis Rio Colorado, Mexico.

References: 1. Aslam MR, Muhammad Asif H, Ahmad K, et al.

Global impact and contributing factors in varicose vein disease development. SAGE Open Med. 2022;10. doi:10.1177/20503121221118992/ FORMAT/EPUB 2. Brittenden J, Cooper D, Dimitrova M, et al. Fiveyear outcomes of a randomized trial of treatments for varicose veins. New England Journal of Medicine. 2019;381(10):912–922. doi:10.1056/ NEJMOA1805186/SUPPL_FILE/NEJMOA1805186_ DATA-SHARING.PDF 3. Gobierno de Mexico. Data Mexico Salud. Data Mexico Economia.

4. González-Ochoa AJ. Epidemiology of chronic venous disease in Mexico and its impact on quality of life. Rev Mex Angiol. 2023;51(2):35–44. doi:10.24875/RMA.22000046 5. Valeria Villareal. How do Mexicans get healthcare?

Wilson Center.

6. Mezalek T, Feodor T, Chernukha L, et al. VEIN STEP: A prospective, observational, international study to assess effectiveness of conservative treatments in chronic venous disease. Adv Ther. doi:10.1007/ s12325-023-02643-6.

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October 2023 / Issue 16

Interview

PROFILE

STEPHEN BLACK

Stephen Black, MD, speaks to Venous News about his career to date. Despite having, in his own words, done “terribly” in an interview for a vascular senior house officer role at St Mary’s Hospital in London, England, Black is now consultant vascular surgeon at Guy’s and St Thomas’ NHS Foundation Trust and professor of venous surgery at King’s College London. He is on the cutting edge of venous research and is currently co-principal investigator for multiple clinical trials including ABRE, VIAFORT and DEFIANCE. Alongside discussing his own career, Black also considers the state of the venous field more widely, outlining patient selection and “maintenance of results” as two of the biggest challenges at present. Randomized data in the field are much needed, he says, indicating that ‘big data’ and artificial intelligence (AI) might provide some solutions to the difficulties of conducting such research. Finally, Black outlines his hobbies and interests outside of medicine, highlighting the importance of his family and a love for sport.

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

I grew up in South Africa and we were given a very clear set of instructions at school.

Choose between law, accounting, medicine or engineering. So, I chose medicine. Not particularly romantic but it made the most sense. Nowadays we would have likely had a very different discussion.

Vascular came about really by a series of decisions, none of which were conscious decisions, to choose it. I had wanted to do plastic surgery or orthopedics and having moved from South Africa to the UK, I was working as a locum in Brighton. I was, at the time, living in Parsons Green, London, and the commute became really tricky. I looked in the British Medical Journal careers section and saw a senior house officer job in vascular advertised at St Mary’s Hospital. The commute to Mary’s was much easier so I applied for it.

I was interviewed by Mike Jenkins and Nick Cheshire and did terribly. Ultimately, however, I got the job (after a few others dropped out!) and so began my journey in vascular. I ended up doing my research at Mary’s with John Wolfe and never looked back. Sometimes you have to go where the current takes you.

Who have been your career mentors and what is the best advice they have given?

I have been fortunate to have had many great mentors over the years. Bernie Little was a general surgeon and Head of Department at Edendale Hospital in Pietermaritzburg, South Africa. He was fantastic in setting me up for a career in surgery. After that I benefited a lot from support from Richard Corbett, a vascular surgeon in Haywards Heath, England, where I was a locum, who got me onto my first projects and was very supportive.

From the time of getting to Mary’s, John Wolfe, Mike Jenkins and Rick Gibbs were amazing and helped me navigate the politics of research. I have not always been very good at that! My subsequent training really benefited from support from all the people I trained with. Neil Browning, Martin Thomas, Kieren Dawson at Ashford and St Peters Hospital (Chertsey, England), Peter Leopold and David Gerrard at Frimley Hospital (Frimley, England), and then Kevin Burnand, Peter Taylor and Rachel Bell at St Thomas’ Hospital

and Ian Loftus, Matt Thompson and Tom Loosemore at St George’s Hospital (London, England). I think all contributed hugely to shaping the way I think and act as a surgeon and gave me the confidence to develop and grow. Rachel in particular was instrumental in helping me get to St Thomas’ and I will always be grateful for that.

The main advice that was consistent from all of them was a simple plan is a good plan. I have always taken that to heart. It is very easy to try and overcomplicate surgery, particularly in the endovascular era.

Outside of my training I have been grateful to meet and learn from amazing people in the venous space—Peter Neglen and Bo Eklof were amazing in setting me up for success and I have really learned a lot from Gerry O’Sullivan, Rick De Graaf, Nils Kucher, Neils Baekgaard, Erin Murphy, Marianne De Maeseneer, Kush Desai, Nicos Labropoulus, Tony Gasparis and Steve Elias. I genuinely would not be where I am without them. The venous world has a phenomenal group of enthusiastic physicians and there are a number of others that I could include in this list.

It is not, however, just about mentors. I have been very lucky to have a great team at St Thomas’ without whom I would be a failure.

Karen Breen, Beverley Hunt, Ander Cohen (thrombosis experts), Lily Benton, Diana Roque, Eleanor Davies, Belen Quintana, Azeb Mengtsu, Vanessa Livingstone (research team and clinical nurse specialists), Chung Lim, Emma Wilton, Leslie Fiengo, Taha Kahn, Mohamed Sayed, Mohamad Taha (great fellows), Adam Gwozdz, Rachael Morris, Anna Pouncey and Ehsanhul Choudhery (research fellows) have all made work fun and special. Now, my consultant colleagues in venous—Soundrie Padayachee (duplex), Taha Kahn, Prakash Saha and Bhavesh Natha— have added tremendous value. There are of course multiple other team members and I am grateful to them all. Success is never a solo pursuit.

What has been the most important development in the venous space during your career so far?

I think the introduction of dedicated venous stents really changed things. At that time they were introduced, treating venous patients was still a swear word in many respects, but that view has changed dramatically in the last few

FACT FILE EDUCATION AND TRAINING 1998: Graduated from the University of the Witwatersrand Medical School in Johannesburg, South Africa 2006: Completed a doctorate (MD) at St Mary’s Hospital and Imperial College London in London, England

POSITIONS IN VASCULAR SURGERY ORGANIZATIONS Program director for the Charing Cross (CX) Symposium Committee member of the European Venous Forum (EVF) Hands On Workshop (EVF HOW) Examiner for the fellowship of the European Board of Vascular Surgery

CLINICAL TRIALS Global co-principal investigator, Medtronic ABRE Global study Global co-principal investigator, Gore VIAFORT study

years. This brought growth and ultimately led to all the large medical technology companies really committing to the venous space. Allied with growth in thrombectomy devices there is really now a tangible change in the attitude to venous.

What are the biggest challenges currently facing the venous world?

I think the biggest challenge is patient selection and what I would call maintenance of results. Unlike peripheral arterial disease (PAD) and aortic patients, venous patients need the procedure to last for 40–50 years, and we need to make sure we can do that. We have already seen from the investigational device exemption (IDE) studies that there is a patency drop off at three years and this needs to be better. We need to move from a focus on the stent to how we can improve the longterm outcomes.

You are the global and UK principal investigator for a number of ongoing trials. Could you outline some of the research you are currently involved in? Is there a trial you are particularly excited to see the results for?

I am particularly excited by three new studies. The Gore VIAFORT study, which I am doing with Kush Desai, is introducing the first dedicated inferior vena cava (IVC) stent, which will give us something different for these patients and hopefully improve the outcomes in this difficult group.

DEFIANCE, funded by Inari Medical, is a randomized controlled trial (RCT) for mechanical thrombectomy. We absolutely need more data in this space and it's great that Inari have committed to this. We are using the same core lab and training as ATTRACT so I hope this will give us a positive study—or at least show if we are on totally the wrong track.

The final study is DEXTERITY from Mercator MedSystems. This is particularly interesting, and I hope paves the way for broadening treatments to the femoropopliteal segment. This is a very neglected part of venous and the patients struggle. I think the potential of drug therapy delivered directly to the vessel wall is really exciting.

What do you think are some of the major trials needed in the venous space?

We absolutely need more RCTs in all areas

Issue 16 / October 2023

11

alisonlang.com

Interview

but these have proved hard to deliver. I think this is due to equipoise problems for both patients and doctors.

There are some novel trial designs and I hope these will change the nature of how we do studies in the future. We need data for acute and chronic treatment plus ulcer care. In the latter, we especially need data on the role of the deep system in ulcer recurrence and failure to heal.

What do you think research might look like in the future? Are there alternatives to the ‘gold standard’ of the randomized controlled trial?

As above I think the potential lies in so-called ‘big data’. There are opportunities to utilize this and artificial intelligence (AI)-driven analysis that allow us to derive answers using the concept of causal inference for example.

This may help address recruitment problems and cost.

There is little point in an RCT that takes ten years to finish recruitment as by that time the goal posts have always moved.

Could you outline one of your most memorable cases?

I still remember the first-in-human VICI case that I performed in 2014. She was a young Spanish lady with very significant venous claudication and we got a really good result.

This was pivotal for me as I was fortunate to be able to do the case and was joined by Peter Neglen. It was really special to operate with him.

She has now been fine for nine years and has gone on to have children and been symptom free. It opened my eyes to the potential in treating venous outflow obstruction.

What advice would you give to someone looking to start a career in medicine and/or looking to specialize in venous surgery?

Medicine is an exciting and diverse career. If making money is the sole objective it's not the career to choose, but if you want to transform lives and influence the world in a small way then it is a great career. Venous is an open

“It is very easy to try and over complicate surgery, particularly in the endovascular era.”

field with enormous opportunity to shape the future for young surgeons, radiologists or other specialists who treat this disease.

We have a lot to learn and there are so many patients who still need solutions.

There is no better opportunity to make a mark than venous right now in vascular surgery.

What are your hobbies and interests outside of medicine?

My main focus outside medicine is my family.

I am married to a long-suffering wife, Quita, who has had to put up with me and done an amazing job at that. I have two great kids, Amber-Jade and James, and I really enjoy spending time with them and supporting their sport and journey through life. I would be lost without them.

Apart from that my main interest is rugby. I am a die-hard Springbok fan and match days are a perpetual cauldron of emotion. I will pretty much watch any sport and enjoy trying to play (badly) where I can. My kids have recently convinced me to take up hockey!

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October 2023 / Issue 16

Section Name

research team reported. success in both. “All patients who effective outpatient management of Outpatient The findings were presented by were provided the option for outpatient acute iliofemoral DVT with MayDaniel Nguyen, BS, a medical student management—and left—returned.

Thurner Syndrome through mechanical treatment of from the University of Arizona College All outpatient cases were treated thrombectomy, angioplasty and of Medicine in Tucson, Arizona, at the successfully and were not converted to Nguyen concluded. “This acute iliofemoral Western Vascular Society (WVS) annual inpatient.” None developed a pulmonary stenting,” helps alleviate hospital resources, meeting in Koloa, Hawaii (Sept. 9–12). embolism in the interim, he added. accommodates for operating room DVT shown to The Arizona group, led by senior “In a time where many institutions staffing availability, mitigates expenses author Joshua A. Balderman, MD, are facing limitations, our data show for the patient and does not affect be just as began offering the management option we are able to provide safe and patient outcomes.” of outpatient treatment of non-emergent effective as DVT amid the healthcare and staffing limitations wrought by the COVID-19 ECMO can help salvage patients standard pandemic. undergoing mechanical thrombectomy Outpatients included in inpatient the study either had for acute PE not previously been method admitted prior to their A retrospective investigation of cardiovascular collapse during Daniel Nguyen

An analysis of nearly 100 patients who underwent mechanical thrombectomy angioplasty and stenting for acute iliofemoral deep vein thrombosis (DVT) with May-Thurner Syndrome showed the procedure could be carried out just as safely and effectively in the outpatient setting as in the usual inpatient environment.

DATA FROM THE retrospective review of patients treated by researchers from Pima Heart and Vascular and the University of Arizona showed greater than 75% primary patency out to one year in both those treated as inpatients and outpatients. The outpatient group showed superiority, though the analysis showed no statistically significant difference, the

vascular surgery consultation or were willing to be discharged starting on day one; were able to take direct oral anticoagulation (DOAC) therapy; and had the capacity to return within one-to-two weeks for intervention. Of the 92 patients who met inclusion criteria, 58 received treatment as an outpatient and 32 underwent the procedure—carried out with the ClotTriever device (Inari Medical)— as inpatients during a study period spanning from January 2020 to October 2022.

“There were no significant differences in patient demographics for the inpatient versus outpatient groups,” Nguyen told WVS 2023, reporting 100% technical

mechanical thrombectomy for intermediate- to high-risk pulmonary embolism (PE) found that extracorporeal membrane oxygenation (ECMO) can help to rescue patients who go into cardiac arrest periprocedurally.

Researchers behind the study, led by Eric Peden, MD, an associate professor of cardiovascular surgery at Houston Methodist in Houston, Texas, analyzed 151 patients who underwent large-bore aspiration thrombectomy with the FlowTriever device (Inari Medical), uncovering data that showed 6% (nine patients) went into cardiac arrest during the procedure.

Four of them were rescued with ECMO, with residual PE subsequently removed before discharge by surgical embolectomy in two and repeat mechanical thrombectomy performed in the other two, they reported.

The data were recently published in the Journal of Vascular Surgery-Venous and Lymphatic Disorders and originally presented at the 2023 annual meeting of the Southern Association for Vascular Surgery (SAVS) in Rio Grande, Puerto Rico (Jan. 18–21) by Bright Benfor, MD, a postdoctoral fellow at Houston Methodist.

A 98.7% technical success rate for the mechanical thrombectomy procedure was achieved among the patient cohort.

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Issue 16 / October 2023

IVC Research

13

REGIONALS

Data shore up ‘acceptability’ of IVC reconstruction patency and survival rates Data from a 10-year experience at the University of Colorado of inferior vena cava (IVC) surgical reconstructions following oncologic resections demonstrated “acceptable” long-term patency and survival.

SURVIVAL AT ONE AND FIVE YEARS was 86.5% and 71%, respectively, after either direct repair, patch angioplasty or interposition grafting of the IVC related to abdominopelvic tumor resections mainly due to the malignancy that these patients had. Patency was shown to be 97.6% at one year and 80% after five. The data emerged during a scientific session at the 2023 annual meeting of the Western Vascular Society (WVS) held in Koloa, Hawaii (Sept.

9–12), presented by Pedro J. Furtado Neves, MD, a postdoctoral vascular surgery research fellow at the institution located in Aurora, Colorado.

Some 80 patients were included in the retrospective institutional review, half of whom underwent patch angioplasty, 40% direct repair, and 12.5% interposition grafting. Most of the cohort were recorded as ASA classification 3 and 4, Neves told WVS 2023, and most of the tumors were either renal cell carcinomas (56.3%), leiomyosarcomas (10%), lipocarcomas (8.75%) and germ cell testicular tumors

Novel inferior vena cava filter retrieval device slashes procedural time and radiation exposure during in vivo experiments, Yale researchers report An inferior vena cava (IVC) retrieval device dubbed the next-generation in removal of the venous thromboembolism-fighting tools could substantially cut procedural times and radiation exposure according to data emerging out of in vivo testing at Yale University.

THE ARTICULATING Atraumatic Grasper is the brainchild of Cassius Iyad Ochoa Chaar, MD, associate professor of vascular surgery at Yale in New Haven, Connecticut, and colleagues, with in vitro and in vivo testing presented earlier this year.

The grasper got a fresh airing during the 2023 annual meeting of the New England Society for Vascular Surgery (NESVS) in Boston (Oct. 6–8), during which presenting author Valentyna Kostiuk, a Yale medical student and aspiring vascular surgeon, showed attendees how an advanced technique currently used in practice was deployed to retrieve a tilted filter in a patient, compared to a similarly positioned filter in a porcine model that was captured using the emerging grasper. In the case of the former, the procedural time was 55 minutes. During the example taken from in vivo testing, the procedural time was 11 minutes.

The data show great promise for the novel retrieval device to improve the efficiency of IVC filter removal procedures, Kostiuk told NESVS 2023.

So far, in vitro testing—which involved IVC filters being anchored to the inner wall of a flexible tube simulating the IVC and a high-contrast backlit camera view simulating 2D fluoroscopy projection during retrieval in the operating room—has demonstrated comparable retrieval times between the grasper and a

standard-of-care snare device to remove a retrievable IVC filter in a centered configuration. However, the grasper device was also effective to remove permanent filters in both centered and tilted configurations that could not be retrieved using a standard snare device. Additionally, Ochoa Chaar and colleagues found that grasper removal of a centered permanent filter required “significantly less time”—29 seconds vs. 79 seconds when compared to the snare removal of a retrievable filter in a centered configuration.

In the case of in vivo testing in a porcine model, six tilted infrarenal IVC filters were retrieved with the grasper via the right jugular approach.

Comparison analysis between animal and patient procedures was performed for total procedure time, and both retrieval and fluoroscopy time.

They showed that all IVC filters were retrieved using the grasper with no adverse events. The total procedure and fluoroscopy times were reduced by more than 50% in the pig group compared to the 12-patient match group—“significantly shorter,” the Yale researchers report. “Moreover, in the patient group, 16.7% of retrievals required advanced endovascular techniques and one IVC filter could not be retrieved [success rate= 91.7%], while all the IVC filters were successfully retrieved in the animal model without the use of

(7.5%) with retroperitoneal metastases. “A total of 10 patients had occlusive or nearly occlusive thrombosis of the IVC out of a total of 80 patients, of which 50% was due to local tumor recurrency compressing upon the reconstruction, and 40% were within 30 days so Pedro J. Furtado Neves we classified this as technical,” he said. “The majority of IVC reconstructions were performed with direct repair or patch angioplasty, which represents a more recent trend. Long-term patency and survival following IVC oncologic reconstructions are acceptable. Most occlusions and stenoses are rare and likely due to local recurrence or technical issues, which encourages intraoperative confirmation of no residual stenoses and the active search for a negative margin in the patients in these surgeries.”

additional tools.”

Kostiuk, speaking to Venous News after delivering her video presentation at NESVS 2023, highlighted the potential advance of the grasper over current standard of care in IVC filter removal. “Standard removal devices we have right now consist of a snare, so in order to remove the filter, you need to have the hook available to be captured by the snare loops.”

The case of the more advanced current technique—involving a wire loop and a snare—that was used in the case of the 27-year-old patient with a 9-degree tilted configuration who featured in her NESVS presentation further elucidates where practice currently stands, Kostiuk explained.

reposition the IVC filter and make its hook more accessible to be captured by the snare device. Thus, the use of multiple devices—snares and wire loops—during advanced endovascular retrievals significantly prolongs the total procedure and fluoroscopy time, and is associated with complications.”

The advantage of the grasper, on the other hand, lies in a novel design consisting of two unique features: the articulating arm with lateral movements that allow to direct the grasper device to the tilted IVC filter in any configuration, and a pair of grasping jaws, which can grasp the filter hook or filter neck—is particularly useful for filters with extreme lateral tilt or hook abutment to the IVC wall, Kostiuk explained. “Even if the hook is embedded in the IVC wall, or if the filter has been there for years and the hook is covered with scar tissue and not available to be captured by a snare and wires, you can still use the grasping jaws to engage the neck of the filter and to capture the filter,” she said.

“The hook is not that critical anymore.”

Kostiuk emphasized the in vivo case featured in the NESVS video: “This procedure took 11 minutes in the pig, while the other procedure that we showed in the patient, using Clockwise from top left: Valentyna Kostiuk; the wire loop and the snare—it Cassisus Iyad Ochoa Chaar; Kostiuk took 55 minutes,” she said. presenting at the NESVS annual meeting; the Articulating Atraumatic Grasper “That is five times the amount device in action of time to capture the filter.

This also means much more “You have one big wire loop already radiation. So, we make it significantly holding the filter, and one snare device safer for the patient—and faster for the with multiple loops, to try to capture vascular surgeons carrying out these the hook,” she said. “The problem is, procedures.” if you have a filter with significant The Yale researchers are currently lateral tilt, the filter can about the carrying out market analysis with a IVC wall, and it is really impossible view to advancing development of the to capture the hook using the snare grasper device as they look to perform only. Such complex configuration clinical studies to evaluate its safety requires the use of a wire loop to for use in patients.

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Issue 16 / October 2023

ESVS 2023

Multimodal imaging for venous disease: A how-to guide Start with a duplex scan, continue with axial imaging, and then assess with venography and intravascular ultrasound (IVUS). This was the advice of Efthymios (Makis) Avgerinos, MD, speaking on the standard of care that is multimodal imaging in assessing venous disease at the recent European Society for Vascular Surgery 37th annual meeting (Sept. 26–29) in Belfast, Northern Ireland.

T

he importance of identifying symptoms prior to conducting any imaging was a key message from the talk. Before beginning his run-through of using multimodal imaging, Avgerinos, of Athens Medical Center and the University of Athens in Greece, first advised: “We shouldn’t be talking of venous imaging unless we have a clinical suspicion that something is going on with the pelvic veins, unless [the patient] has back pain or abdominopelvic pain, a swollen leg, or varicose veins in unusual sites like the pubic area or the posterior thigh.”

Avgerinos noted that there are four anatomic levels that should be considered when it comes to identifying pathologic pelvic veins.

Based on the most recent Symptoms, varices and pathophysiology (SVP) classification by Mark Meissner, MD, these are: the left renal vein level, the iliac and gonadal vein level, the extrapubic varicosities, and the lower leg level. “We are looking for reflux, or we are looking for obstruction,” he said.

The presenter noted that there are four imaging modalities available at present—duplex scan, axial imaging, venography, and IVUS.

Duplex scan: “Not an easy-to-do ultrasound”

“Starting from the basics,” Avgerinos said, “the pelvic ultrasound”. This, he advised, will determine the pathophysiology and hemodynamics of pelvic venous disease (PeVD).

“We can measure diameters, identify obstructions, identify reflux and the sources of reflux, and we can also identify the varices,” he said, outlining the uses of duplex.

He also shared the “various” criteria available on how to document and establish a diagnosis of PeVD. The most frequently used ones are dilated veins of more than 5mm around the ovary and the uterus; dilated transuterine veins connecting the left and right uterine veins; and disappearance of, altered, or reversed flow with the Valsalva maneuver.

“This is not an easy-to-do ultrasound,” Avgerinos warned. “It requires expertise, dedication and time.” He also urged delegates to “be aware” that “it really matters how the patient is standing”.

The presenter explained: “If you

have the patient in the supine position, most of the time you are going to see compression at the common iliac, compression at the left renal vein.

If you have the patient in the supine position, you are going to miss reflux of the ovarian vein, you are going to miss reflux of the internal iliac veins, so you should get these patients in the standing position, and, many times, you are going to see the compression disappear, or you may actually uncover a reflux.”

Axial imaging: “We don’t look at images unless the patient has relevant symptoms”

Moving on to axial imaging, Avgerinos explained that this encompasses computed tomography (CT) venograms and magnetic resonance (MR) venograms. While practitioners might be more familiar with the former, the presenter highlighted the radiation hazards associated with this type of imaging, particularly for younger patients and those of childbearing age.

MR venogram, Avgerinos stated, has the benefit of being able to also provide venous flow information, however there is one major downside: “it’s not readily available, not many institutions have it”.

He also warned: “With axial imaging, if you get 100 asymptomatic patients, 25 of them are going to have a left common iliac vein compression and one-third of the patients are going to have a left renal vein compression, so, again, we don’t look at images unless the patient has relevant symptoms.”

explained is a white area in the middle of an image that shows compression of an overlying common iliac artery—as well as midline crossing, when there is internal iliac vein reflux, or varicose veins that can be seen down into the proximal thigh by injecting contrast in a refluxing internal iliac vein.

“Venography is not always accurate though,” Avgerinos warned, noting that “it really depends on the rotation that you give in your C-arm to identify the stenosis—you may actually miss it”.

In addition, he stressed that veins have a low flow, multiple curves, and collateral washout, and given that stenosis >50% is “significant” it can be “difficult to visualize with a venogram”.

when IVUS was used.

Avgerinos listed some further benefits of the technology: “You don’t need to use much contrast, you decrease radiation, you have a better sensitivity in your diagnostic testing, you have better and more accurate diameter measurements, you have better visualization of your stent to position it, and to assess its expansion.”

The presenter added: “By using IVUS, you can guarantee that you're giving your patient the best shot for a long-term patency.” He referenced his work at the University of Pittsburgh, Pennsylvania, of IVUS versus no IVUS, sharing that patency was “significantly higher” for patients in whom IVUS was used because lesions were not missed.

IVUS: “You’re giving Despite these multiple Efthymios your patient the best benefits, Avgerinos did Avgerinos shot for a longurge caution. “Be careful term patency” with IVUS,” he said, “because you This is where IVUS technology comes may get overdiagnosis.” To this point, in. Avgerinos noted that, currently, this he showed a series of images that is the standard of care for the diagnosis demonstrated a compressed common of venous obstruction, with two iliac vein with a patient in the supine technologies on the market at present: position, compared to a drastically one from Boston Scientific, another different image with the patient lying from Philips. With IVUS, he said, “you on their left side or standing up. can see every little luminal, wall, and extraluminal detail”.

“Treat symptoms, not images” There are data indicating how many Closing his presentation, more lesions IVUS can identify against Avgerinos stressed that “imaging traditional venography, the presenter for PeVD should always follow pointed out, turning the audience’s relevant symptomatology” and attention to the Venogram versus IVUS that it is important to identify all for diagnosis iliac vein obstruction communications between the pelvic (VIDIO) trial, in which the treatment and the leg veins. In addition, he plan changed in 57 out of 100 cases shared that no single imaging modality is ideal, and easy to perform and interpret. He advised delegates to start with duplex—stressing that this needs competency—continue with axial imaging, and then assess further with a complete venography and IVUS, closing with his key message of “treat symptoms, not images”.

“Imaging for PeVD should always follow relevant symptomatology.”

Venography: “Not always accurate”

Avgerinos then turned his attention to venography. He informed delegates that a full venographic assessment for PeVD should include the inferior vena cava (IVC), the right and left ovarian veins, the common iliac, and the internal iliac veins. The scope is to identify reflux or obstruction.

In terms of identifying common iliac vein stenosis, the presenter pointed out that this is not something that can often be seen directly. “You need to be familiar with the indirect signs of common iliac vein compression,” he advised.

Sharing the details of some of these “indirect” indicators, Avgerinos highlighted contrast stagnation, ‘pancaking’, the ‘bull’s eye’—which he

15

Examples of imaging for venous disease (courtesy of Efthymios Avgerinos)

16

October 2023 / Issue 16

UIP 2023 DEEP/PELVIC

Quick, noninvasive, accurate: New PeVD screening tool holds potential “There is a pressing need for an effective, patientcentric and accurate screening tool” for pelvic venous disorders, says Tasneem G Pope, MBBS Cantab, of Imperial College London in London, England, speaking at the International Union of Phlebology (UIP) World Congress (Sept. 17–21) in Miami. 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.

A common yet often undiagnosed condition worldwide, 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 explained.

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 was 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 was 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 four-item 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.

Screening tool shows promise

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 deliveries.

Further studies, including validation of this tool in a larger prospective cohort and in a

Are NIVL patients being over-stented?

Parameters for patient selection are “poorly defined” for the treatment of nonthrombotic iliac vein lesions (NIVL), Kush Desai, MD, of Northwestern University in Chicago, told delegates at UIP 2023.

“NIVL IS NOT A DISEASE OF mortality, it is a disease of quality of life, so we want to treat it with the commensurate amount of care,” he cautioned. Currently, most consider failure in the treatment of NIVL as a loss of stent patency, but Desai believes a lack of clinical improvement is “pretty clearly” the more appropriate marker. A 2015 meta-analysis found that stents placed for NIVL had very high patency projected at five years, indicating that a loss of patency was not tied to failure in NIVL treatment.

Desai noted that this finding has since been confirmed in multiple investigational device exemption (IDE) trials, and states that more datasets are forthcoming.

“Then the question is,” he continued, “do all patients show improvement

following iliac vein stent placement?”.

Another prospective cohort study, published in the European Journal of Vascular and Endovascular Surgery in 2018, reported that 63% of NIVL patients showed improvement following stent placement; a further 23% had no response, and 14% became slightly worse. The authors noted that they found “a remarkably high percentage of anomalous angiographic examinations of the deep pelvic veins” in young healthy patients.

“Taking this group of patients as a population, I personally find that abysmal,” Desai said. “It is a permanent prosthetic in a young patient—I do not think that we should accept that as something to be proud of. These patients will have stents for multiple decades, and nobody yet has a dataset

In total, 73 women out of the 94 met the duplex ultrasound criteria, giving a prevalence of 78%

73 out of 94 78% Of the 34 women who completed the specific score, the prevalence was 85%

34 85%

confirming that everything will be okay—it may be, but it also might not be. It could end up being a potential litigation problem down the line.”

Potential over-stenting of NIVL patients

Many patients are treated for NIVL based on having a 50% area (intravascular ultrasound [IVUS]) reduction of the iliofemoral veins, most commonly at a compression site in the left common iliac vein from the overriding right common iliac artery. Desai claimed that there are no clear, multicenter data to support this criterion, adding that he believes this 50% treatment threshold is “not validated,” though he admitted that this is “certainly up for debate”.

In the multicenter VIDIO trial, which prospectively enrolled 100 C4–C6 patients (of which 68 received stents), the investigators found that in a 48-patient subset analysis of NIVL, IVUS diameter rather than area measurements of baseline stenosis were significantly predictive of clinical success, but indicated that a higher

population with a low prevalence of the disease, are required. Pope recognized 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 ultrasounddefined 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 co-investigators 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’s no, in the score, you’re more likely to have PeVD if other gynecological issues have been ruled that.”

optimal threshold of stenosis (>61% diameter reduction) may be necessary.

“It is a small study”, Desai noted, “but it is the first multicenter study [on the usefulness of IVUS at predicting when stent placement will result in clinical improvement] and the authors found that there is no correlation with area stenosis [and success of NIVL treatment]”.

Desai commented that it is possible for IVUS or venography to be “positive,” but for the patient to not have clinical disease—which would mean that the patient does not require treatment for NIVL. Patient selection for NIVL is difficult. Symptoms can be “highly variable”, in Desai’s words, and edema can arise from etiologies other than venous obstruction.

Most stents, at least in the U.S., are placed for C3 disease, yet there has never been a published study showing that limb volume decreases following non-thrombotic iliac vein lesion stent placement. Desai is unconvinced, telling the UIP audience: “I am not sure I totally trust that it does get better”.

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Issue 16 / October 2023

Market Watch

Clinical News Aidoc’s AI solution for PE clinically proven to reduce hospital stay duration and improve patient access to treatment

Product News New clinical data support Viz. ai solution for improved PE detection and care coordination

Viz.ai has announced new clinical data from two studies demonstrating Research in the advancement of the real-world clinical efficacy of Viz. artificial intelligence (AI)-driven ai’s pulmonary embolism (PE) module pulmonary embolism (PE) care to quickly and accurately was unveiled recently during identify PE and associated the 9th Annual Pulmonary right heart strain, accelerate Embolism Symposium (Sept. care coordination, and improve 21–23) in Austin, Texas. healthcare workflow efficiency.

A press release reports The first study, ‘Automated that research from three PE clot detection and RV/LV institutions utilizing Aidoc’s ratio measurement using AI PE AI solution demonstrated [artificial intelligence]-based clinical value in reducing deep learning algorithms: a mean hospital length of stay, preliminary validation study,’ improving patient access, evaluated the performance Viz.ai mobile viewer for the Viz of Viz PE and Viz right and correctly alerting care PE module teams of suspected PEs ventricle/left ventricle (RV/ with potential for advanced LV) algorithms. The study interventions. found that, across 100 retrospectively The three studies highlighted the care collected chest computed tomography advantages of utilizing Aidoc in the pulmonary angiogram (CTPA) images, management of acute PEs, including Viz PE demonstrated a sensitivity numerous patient outcome benefits. of 91.1% and specificity of 100%.

Key findings from the studies presented Furthermore, the study revealed a include: significant positive correlation between ● 37% hospital length of stay algorithmic and manual calculation of reduction with AI-triggered RV/LV ratio.

Pulmonary embolism response “Our preliminary findings underscore team (PERT) activation and the remarkable performance of Viz PE initiation of advanced therapies and Viz RV/LV,” said Parth Rali, MD, ● 68% increased access of catheterof Temple University in Philadelphia, directed interventional therapy for Pennsylvania. “We are excited to intermediate-high to high acuity partner with Viz.ai and pioneer PE patients investigator-initiated research that will ● A highly sensitive (95%) early reveal the impact of AI technology in alerting system that successfully revolutionizing patient care.” identified critical PE patients The second study, ‘The use of “Proving the robustness of any AI artificial intelligence technology solution hinges on the application of in the detection and treatment of scientific rigor and the scrutiny of peer pulmonary embolism at a tertiary review,” shared Jerome Avondo, VP of referral center,’ demonstrated how Clinical Affairs and Reimbursement, Viz PE directly improves patient wait Aidoc. times for evaluation. Adoption of Viz. “Collaborating with these esteemed ai’s technology significantly reduced institutions to evaluate Aidoc’s PE time to consult on average from four AI solutions is critical to increasing hours to six minutes, leading to faster awareness of the multifaceted diagnosis and initiation of treatment. benefits AI can provide to patients, When combined with multidisciplinary providers and health systems. A evaluation by an existing Pulmonary difficult to manage, high acuity patient embolism response team (PERT), time population, such as PE, presents to radiology report was reduced by novel opportunities for assessing the 109 minutes, showcasing the potential impact of artificial intelligence and combined benefits of AI technology understanding the overall impact on and the PERT model of care on PE care outcomes.” and management, Viz.ai claims.

UK MHRA adds capacity for medical device certification

and by witnessing some of their audits of manufacturers.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) Updated ClosureFast has designated three new approved radiofrequency ablation catheter bodies to increase the country’s receives US FDA 510(k) clearance capacity to certify medical devices. for treatment of CVI TÜV SÜD, Intertek, and TÜV Medtronic has announced that an Rheinland UK join the four current updated ClosureFast radiofrequency UK Approved Bodies, almost doubling ablation (RFA) catheter in a lower 6Fr current capacity for the certification profile is now available in the U.S. of medical devices in the UK, MHRA following 510(k) clearance from the says in a press release.

Food and Drug Administration (FDA).

TÜV SÜD and Intertek have been The ClosureFast procedure is intended designated as UK Approved Bodies to treat chronic venous insufficiency to assess and certify general medical (CVI). devices in accordance with Part II of “For patients with mild tortuosity in the UK Medical Devices Regulations their saphenous veins, where I would 2002. TÜV Rheinland UK has also normally use a wire or two access been designated to assess and certify points, I have found that the new general medical devices as well ClosureFast 6Fr system glides as in-vitro diagnostics in through more easily than accordance with Part IV. the 7Fr system, providing With the exception a better periprocedural of the very lowest risk experience for the devices, manufacturers patient,” said Misaki must apply to a UK Kiguchi, MD, of MedStar approved body for UKCA Heart and Vascular certification. Products Institute in Washington, can only be placed on the DC. market in England, Wales Medtronic states that the ClosureFast and Scotland after they have ClosureFast procedure is achieved certification. the global market leader in RFA for Laura Squire, MHRA chief the treatment of CVI and has 200+ healthcare quality and access officer, published clinical studies and articles. said: “By almost doubling capacity for A press release details that medical device assessment in the UK, ClosureFast 6Fr builds upon the we’re supporting patients to access the technology’s proven platform. New safe and effective products they need to features in the updated ClosureFast protect their health.

RFA catheter include: “Approved Bodies play a critical ● A lower profile 6Fr catheter role in the supply of medical devices designed for better flexibility, and expanding capacity has been a key easier navigation, and greater kink priority for us to support manufacturers resistance, even in tortuous veins to bring their products to the UK.” ● Increased length of the heating Before appointing an Approved element (from 7cm to 8cm) for Body, the MHRA conducts a detailed greater procedural efficiency assessment process to ensure that “Offering the ClosureFast catheter organizations are stable and able to in a lower 6Fr profile is part of our undertake impartial and objective commitment to provide meaningful conformity assessment activities, product advancements for patients,” that they have an appropriate quality said David Moeller, SVP and president management system, the capacity and of Peripheral Vascular Health at competence to undertake assessments Medtronic. “We listened to our and the processes they use meet the customers’ feedback to evolve this relevant regulatory requirements. trusted, market leading technology. The After successful designation, the new features are designed to provide MHRA monitors UK Approved Bodies’ advantages in technical performance activities including by regular audits and procedural efficiency.”

Conderence calendar Oct. 28–30 The VEINS (Venous Endovascular Interventional Strategies) Las Vegas, Nevada

viva-foundation.org/future-meetings

Nov. 14–18 VEITHsymposium New York City

veithsymposium.org/index.php

19

Dec. 1–3 20th European Angiology Days Online europeanangiologydays.net

2024 Jan. 22–25 International Symposium on Endovascular Therapy (ISET) Miami Beach, Florida hmpglobalevents.com/iset

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

March 23–28 Society of Interventional Radiology (SIR) annual meeting London, England

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

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

evfvip.com

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

April 23–25 Charing Cross (CX) Symposium London, England

June 20–22 24th European Venous Forum (EVF) annual meeting Versailles, France

venousforum.org

cxsymposium.com

europeanvenousforum.org

ai169721648415_CX 2024 CX Co-chairs Oct 2023.pdf 1 13/10/2023 18:01:32

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Venous & Lymphatic Controversies

Acute Stroke Controversies

Vascular Access Controversies

The Hurting Leg Controversies

Vascular Trauma Controversies

CMY

CXSYMPOSIUM.COM

K

45 YEAR LEGACY OF VASCULAR EDUCATION CONTINUES CX CO-CHAIRS

ANDREW HOLDEN

DITTMAR BÖCKLER

ERIN MURPHY

EDUCATION

INNOVATION

EVIDENCE