Venous News 18 – June 2024 OUS

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JUNE 2024 / Issue 18

Featured in this issue:

3 Presidential address Outgoing AVF president points to a future that emphasizes outreach

6 The next frontier

Prosthetic valve shows “vast” improvements in chronic venous insufficiency

10 P rofile Gloria Salazar

13 VTE

AI associated with faster time to assessment of PE

“The forgotten stepchild of vascular surgery”: The quest to push forward basic science research in venous disease The 2024 Venous Symposium (May 8–11, New York City, USA) was highlighted by keynote speaker Peter Pappas (Chester, USA), regional medical director and program director of the Venous and Lymphatic Medicine Fellowship at the Center for Vein Restoration. Pappas spoke about new frontiers in venous and lymphatic disease management while looking at the past, present, and future of how disruptive technologies have shaped venous treatment.

New randomised data show cyanoacrylate glue performs strongly on patient satisfaction

By Brian McHugh

Patients undergoing cyanoacrylate glue closure for superficial venous disease reported higher periprocedural satisfaction than those who were treated via surgical stripping, data from a pair of randomised controlled trials (RCTs) assessing the VenaSeal system (Medtronic) reveal.

T

he modality also showed greater improvement in diseasespecific quality-of-life compared to surgery or endothermal ablation. However, at 30 days participants in both the glue closure and stripping arms were similarly satisfied post-procedurally, the primary investigators told the Charing Cross (CX) International Symposium 2024 (April 23–25, London, UK) in the first-time release of results from the Spectrum Program trials.

Similarly, principal investigators Kathleen Gibson (Lake Washington Vascular Surgeons, Bellevue, USA) and Manj Gohel (Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK) reported that in the RCT comparing the VenaSeal system to endothermal ablation, similar patient satisfaction was demonstrated between the two procedures. The results emerged in a Superficial Venous Controversies session at CX 2024.

“The initial results of two of the three studies in the VenaSeal Spectrum Program reinforce the safety and effectiveness of the VenaSeal system as compared to current standards of care,” said John Laird, chief medical officer for the Peripheral Vascular Health business in the Medtronic Cardiovascular portfolio. “As one of the largest clinical programs in the venous space, the

Spectrum Program demonstrates the Medtronic commitment to bring forward data to inform treatment decisions and advance the field of patient-centered research.”

The peri- and postprocedural primary endpoints were measured using the novel Venous Treatment Satisfaction Questionnaire (VenousTSQ) tool, Gohel said. Data from the RCTs also showed that VenaSeal performed similarly to both surgical stripping and endothermal ablation in terms of elimination of truncal reflux, the third primary endpoint. Results from the secondary endpoint measure of modified Aberdeen Varicose Vein Questionnaire (AVVQ) at 30 days showed trends in favor of the VenaSeal system compared to both surgical stripping and endothermal ablation.

When asked whether it is fair to use an AVVQ comparison if the patients are recovering from surgery and how they would advise patients as to which therapeutic option they should

“It is notable that there were trends towards advantages with VenaSeal and it performed comparably with our standards of care” KATHLEEN GIBSON

“IT IS MY HOPE THAT IN THE next 20 to 30 minutes, what I’m about to tell you will inspire a new generation of venous clinicians, researchers, and physicians to do better,” Pappas told the audience.

Pappas began his presentation by speaking about his history as a vascular surgeon. He stated that, when he joined a fellowship at the New Jersey Medical School, he was told “we have this field in venous disease in which there is really not a lot of basic science research. It’s the forgotten stepchild of vascular disease and we really want to elevate the quality of the work that’s being done there.

“Now, I knew nothing about it. As I read the current literature, I quickly realized my mentors were correct and that this was a career opportunity,” Pappas stated. However, he continued with the fellowship and dedicated his first year to benchwork research and his second year to clinical work.

“I was the first vascular surgeon at that time to get a K08 training grant from the National Institutes of Health,” Pappas continued, “and it opened the door for me for the next Continued on page 3

Continued on page 2

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June 2024 / Issue 18

Cover Story

New randomised data show cyanoacrylate glue performs strongly on patient satisfaction Continued from page 1

■ VenousTSQ post-procedural (30 days): The primary endpoint was not met; participants were similarly satisfied post-procedurally (p=0.7954, alpha=0.05) ■ Elimination of truncal reflux: The primary endpoint was not met; VenaSeal system performed similarly as endotheraml ablation (p=0.0858, alpha=0.025) ■ Modified AVVQ: The secondary endpoint was trending in favor of the VenaSeal system at 30 days (p=0.0076, alpha=n/a)

choose, Gibson responded with “if there’s someone where I think that there’s a particular advantage of one technology “This is an innovative study design, incorporating all of over the other, I will advise that.” the usual elements we have seen in other trials, including Gibson continued, saying “If I feel that they’re equally quality-of-life measures and closure rates, but also includes good for them, I present the risks to the patient. I always new outcome measures that are very patient focused on tell them about hypersensitivity, granuloma and nerve how they feel about their procedure and their outcomes,” injury, what their recovery I think will be like, and I will let Gibson said. “We are interested to see going forward them make that choice.” whether we see any differences when we follow them Meanwhile, six-month effectiveness out further. data showed that VenaSeal was non“Participants were satisfied with inferior to surgical stripping, their treatment. The VenaSeal with similar anatomic patients—and all of the closure rates (97.9% patients in general—had vs. 92.9%; p=0.00041). good quality-of-life The equivalent measure improvements at 30 days. was not tested between The VenaSeal patients VenaSeal and endothermal had similar elimination of ablation in the second truncal reflux and closure RCT, but the trial rates compared to what are investigators reported similar the worldwide gold standard. effectiveness in each arm.

There was a low incidence of adverse Kathleen Gibson The VenaSeal versus surgical stripping events, and very similar to what we see and Manj Gohel study included 106 patients, with 53 allocated to in published literature. We did not find any new each group. The VenaSeal versus endothermal ablation adverse events that had not been previously reported.” study included 275 participants, with 136 receiving Despite VenaSeal not meeting all of the patient-specific VenaSeal and 139 receiving endothermal ablation. All primary endpoints, “it is notable that there were trends patients were Clinical, Etiological, Anatomical and towards advantages with VenaSeal and it performed Pathophysiological (CEAP) classification 2–5. comparably with our standards of care,” Gibson added.

The Spectrum Program also contains a third single-arm VenaSeal system vs. surgical stripping RCT (30-day study set to measure VenaSeal’s impact on venous leg outcomes) ulcers (VLUs) in patients with C6 disease. It will measure ■ VenousTSQ peri-procedural: The primary endpoint time to ulcer healing through 12 months. was met, demonstrating superior patient satisfaction “This is a series of three studies, all with traditional for the VenaSeal system peri-procedurally (p=0.0013, outcome measures—a very robust safety assessment—but alpha=0.025) then with additional focus on patient satisfaction,” said ■ VenousTSQ post-procedural (30 days): The primary Gohel. “The patients were similar, although there were endpoint was not met; participants were similarly some subtle differences.” satisfied post-procedurally (p=0.0504, alpha=0.05) Gibson and Gohel were asked whether they saw any ■ Elimination of truncal reflux: The primary endpoint complications from insertion site bleeding during the trial, was not powered for testing due to early study closure; as one of the attendees was a VenaSeal patient and had VenaSeal system performed similarly as surgical a leak from the sheath insertion site two hours after stripping (p=n/a, alpha=n/a) receiving it.

■ Modified AVVQ: The secondary endpoint was trending “No we didn’t,” Gibson responded. “My comment in favor of the VenaSeal system at 30-days (p=0.0039, would be that can happen with any catheter. The lower alpha=n/a) in the leg that you go, the more likely that’s to happen afterwards.”

VenaSeal system vs. endothermal ablation RCT (30The Spectrum Program will follow up with patients over day outcomes) multiple years for select endpoints, expanding the body of ■ VenousTSQ peri-procedural: The primary endpoint long-term evidence for the VenaSeal system. was not met; participants were similarly satisfied periThe VenaSeal closure system is commercially procedurally (p=0.0260, alpha=0.0167) available in the USA and all EU member countries.

Editors-in-chief: Stephen Black, Manj Gohel and Erin Murphy | Publisher: Stephen Greenhalgh Content Director: Urmila Kerslake | Global Commercial Director: Sean Langer Editor: Brian McHugh brian@bibamedical.com | Editorial contribution: Jocelyn Hudson, Bryan Kay and Éva Malpass Design: Terry Hawes and Josh Lyon Advertising: Sean Langer sean@bibamedical.com Subscriptions: subscriptions@bibamedical.com Published by: BIBA News, which is a subsidiary of BIBA Medical Ltd BIBA Medical, Europe, 526 Fulham Road, Fulham, London, SW6 5NR, United Kingdom Tel: +44 (0) 20 7736 8788 BIBA Medical, North America, 155 North Wacker Drive, Suite 4250, Chicago, IL 60606, United States Tel: +1 708-770-7323 Printed by: Buxton Press. Reprint requests and all correspondence regarding the newspaper should be addressed to the editor at the United Kingdom address. © BIBA Medical Ltd, 2024. All rights reserved.

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NEWS IN BRIEF

THE LATEST STORIES FROM THE VENOUS WORLD

n CX VASCULAR LIVE DEBATE: SHOULD NIVL PATIENTS BE STENTED? Should non-thrombotic iliac vein lesion (NIVL) patients be given venous stents? That was the question put to Gerry O’Sullivan (Galway, Ireland), a consultant interventional radiologist at the University Hospital Galway, and Stephen Black (London, UK), a consultant vascular surgeon at Guy’s and St Thomas’ NHS Foundation Trust and professor of venous surgery at King’s College London during a CX Vascular Live discussion moderated

by Erin Murphy (Charlotte, USA), director of the venous and lymphatic program at Atrium Health’s Sanger Heart and Vascular Institute.

For more on this story go to page 4 n IVC 2024 The 2024 International Vein Congress (IVC) in Miami, USA saw Patrick Muck (Cincinnati, USA) speak on the state of the venous stent landscape; Brajesh Lal (Baltimore, USA) discusses when he believes is the best time to use lymphedema pumps and nonsurgical interventions for treating lymphedema; as well as a slew of presenting authors from across the globe delivering selected venous and lymphatics papers set for submission to the Journal of Vascular Surgery-Venous and Lymphatic Disorders (JVS-VL). Meanwhile, Lowell Kabnick (Morristown, USA) ran through next-generation venous devices currently in development.

For more on this story go to page 8 n LYMPHEDEMA A new study reveals a novel non-pneumatic compression device demonstrated statistically significant disruption in limb volume.

For more on this story go to page 12

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Issue 18 / June 2024

Conference Speeches

Outgoing American Venous Forum president addresses history, future direction of society with focus on community outreach At the 2024 American Venous Forum (AVF; March 3–6) in Tampa, USA, Glenn Jacobowitz, professor of Vascular and Endovascular Surgery at NYU Langone Health in New York City, USA, and president of the AVF addressed the audience.

D

uring his presidential speech, Jacobowitz emphasized the future, with plans to increase the expansion of international outreach programs, diversity and equity amongst members, and a focus on young venous specialists. He also stated that, since it has been five years since the previous group retreat where the current five-year plan was outlined, it is time to look ahead to what the next five years hold.

Jacobowitz participated in a retreat last year with former AVF president William A Marston, professor, Division of Vascular Surgery at the University of North

“The forgotten stepchild of vascular surgery”: The quest to push forward basic science research in venous disease Continued from page 1

20 years.” Pappas then explained the different grants currently available, including three types of grants from the American Venous Forum (AVF) for trainees or trained surgeons within the first five years of their careers.

Continuing the discussion on the current state of benchwork research, Pappas referenced a study that was done in a dermatology lab in Europe that was “the last breakthrough in our understanding of the pathophysiology of venous ulceration.

“These investigators determined that macrophages demonstrate different physiologic phenotypes.

You have macrophages that regulate tissue destruction (M1 type), and macrophages that regulate tissue repair (M2 type),” Pappas told the audience.

“In venous disease, there’s a push towards tissue destruction.”

He explained that iron overload from red blood cell extravasation stimulates macrophages to produce tumor necrosis factor alpha (TNFalpha). This cytokine keeps macrophages in the M1 phenotype resulting in ongoing tissue destruction.

Pappas speculated that based on

Carolina Hospitals in Chapel Hill, USA, where there was a focus on making sure all persons have access to prevention and treatment options, addressing the current inequalities in venous care, and increasing access to understanding venous disease prevention and treatment.

Jacobowitz looked back at the past for help in determining the AVF’s future. “The AVF went through a brief time of financial stress and lower membership.

But our leaders identified a need to redefine our mission goals and align these goals in a way to expand our membership and diversify and also restructure our management team and our strategic plan.

“We can’t have a myopic view of the world,” Jacobowitz told the audience. He continued that the AVF has partnered with “35 international societies to increase collaboration and improve management of venous disease globally, leading to information exchange and joint project proposals, including guideline summaries, collaborative research, and education.”

The AVF now has educational offerings around the world, including early training programs, webinars, and planned symposia in South America, Europe, Egypt, and China. There are also international webinars, the first of which was viewed in over 60 countries.

Jacobowitz also mentioned that the AVF recently established more than $200,000 in annual grants.

Those grants include the AVF-Jobst Clinical Research Grant ($85,000), AVF-BSCI Translational Research Grant ($85,000), AVF-NIH/NHLBI Grant ($25,000), AVF Basic Science Research Grant ($15,000), and the

these observations possible future clinical applications could include the utilization of existing TNF-alpha blockers and/or iron chelators to promote wound healing. He added, however, that the current utilization of these drugs have only been tested in animal models.

Disruptive technologies

“So let’s talk a little bit about disruptive technologies,” Pappas told the audience. “Mark Meissner [University of Washington School of Medicine, Seattle, USA] and I were talking one day 15 years ago, and he introduced me to the term disruptive technology when discussing the impact the iPhone had on our daily activities.

“I would submit to you that the major disruptive technology in venous disease was the development of the VNUS catheter, which was originally called the Restore catheter. The original intent of this catheter was to restore venous valvular function and not to destroy the vein. After testing the feasibility of restoring valve function, it was discovered that the technique resulted in vein closure and the rise of thermal ablative technologies.

“I remember sitting in the audience in the early nineties when the first clinical data on thermal ablative technologies was presented. I couldn’t believe this actually worked and I was a late adopter because I wanted to see the data before subjecting patients to this brave new world,” Pappas stated. “As a result, this changed my perspective on the management of venous disease.”

Moving from catheters to stents, Pappas mentioned Raju and Neglen’s

3

AVF Janssen Fellowship ($50,000).

In the new year, there will be “increased focus on young venous specialists,” Jacobowitz stated. “We have a record number this year.” He continued by mentioning advanced practice providers (APP), “We’d like to continue to engage more with APPs and help mitigate the inequalities of care.”

Jacobowitz gave the audience of the forum a call to action near the end of his speech regarding the inequities of care. “It’s a complex problem, a large problem, but it involves the disease process...We need to develop programs to overcome hurdles and develop understanding about the geographically and economically underserved,” he explained.

Jacobowitz concluded by saying the AVF will “lead the way in venous care in the USA and abroad through our own initiatives and through collaborative work with our global partners and industry. All the while they’ll maintain focus on research and mentorship.”

“The AVF will lead the way in venous care in the USA and abroad through our own initiatives and through collaborative work with our global partners and industry” GLENN JACOBOWITZ

groundbreaking paper on the efficacy of Wallstents in patients with venous outflow obstruction.

This paper laid the foundation Peter Pappas for venous stent outcomes, with Pappas telling the audience that “Raju and Neglen’s results are the gold standard to which all future venous stent trials are measured against.

Next, Pappas asked: “What are the current needs of patients in the 2020s and going forward?” For example, “We haven’t really touched the surface of what we can do” when it comes to compression, Pappas stated. When it comes to disruptive technologies and compression, he said that the first use of active sensing technology to monitor compliance in a compression device was a major breakthrough. The first device was bulky and cost prohibitive, so it never really saw widespread utilization. Today, there is a new device from Sun Scientific, which I consider breakthrough technology. It’s an all-inone device that takes the best concepts of what we know about compression.”

The Aero-Wrap compression device allows patients to deliver a specific amount of pressure to their limbs via a handheld pump device. The device also has pneumatic cells that allow it to be converted into a pneumatic pump for lymphedema patients relieving the need to have a compression garment and a separate pneumatic pump.

Another possibility when it comes

to future compression devices is the use of sensing technology. Sensing technology will inform physicians of patient compliance, how often they use it and where the pressure is being applied. Future garments will also provide muscle stimulation through breakthroughs in fiber technology.

Pappas shifted the audience’s attention to thermal technologies.

“As far as I’m concerned, tumescent anesthesia is the biggest problem with thermal technologies,” Pappas said.

“This is an engineering problem. I don’t see why we can’t develop a device that can actually penetrate the vein wall and deliver peri-venous tumescent anesthesia.”

Regarding stents, Pappas believes there are still many technological possibilities coming soon. Specifically, he asks whether the industry can develop drug-eluting stents for postthrombotic patients or biodegradable stents for younger patients with nonthrombotic iliac vein lesions (NIVLs).

Future technologies

“What about the future?” Pappas asked. He believes that, with the advent and continued usage of artificial intelligence, 3D ultrasonography “will be able to give us 3D reconstructions of veins”.

Pappas concluded by looking further into the future. “In my lifetime, we will start to see colonization of our solar system. [Research has shown] astronauts returning to earth developed severe lymphedema that took up to six months to resolve. Space travel will require a new generation of doctors trained in Space Medicine,” he said.

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June 2024 / Issue 18

CX 2024 VENOUS STENTING

CX panel confronts conundrum of the moment: Should NIVL patients get stented?

Should non-thrombotic iliac vein lesion (NIVL) patients be given venous stents?

That was the question raised to Gerry O’Sullivan (Galway, Ireland), a consultant interventional radiologist at the University Hospital Galway, and Stephen Black (London, UK) a consultant vascular surgeon at Guy’s and St Thomas’ NHS Foundation Trust and professor of venous surgery at King’s College London during a recent CX Vascular Live discussion moderated by Erin Murphy (Charlotte, USA), director of the venous and lymphatic program at Atrium Health’s Sanger Heart and Vascular Institute.

believes that what vascular surgeons are looking for is “a tool that would accurately measure or quantify where that iliac vein lesion is and whether a stent is going to benefit. I think that doctors are crying out for that specific tool right now.”

O’Sullivan then assessed the situation in practical terms, saying that the patient should be spoken with to determine what they are willing to do and to set expectations. He suggested asking patients, “Are you willing to wear stockings? Would you be willing to take anti-coagulants? Are you prepared to put up with a vague chance or an outside chance of things going wrong?” He also stated that you must explain to your patients that a stent is not something that can be taken out

he responded. Black added that you should “take a really good history, examine your patients properly, make sure you understand what the other things are that could be driving leg swelling and you’ve eliminated those.”

Black also explained how he sets expectations for his patients, saying that he’ll tell patients that, if swelling is their primary issue with stenting, then “one, it’s a 50/50 shot whether it improves. It may not get better, [and I] make no promises on it. Two, it takes a long time to improve.”

He continued by saying that, if you plan on putting a stent in a C3 patient, you must be absolutely sure that you need to. Black referenced Elias’ argument that C3 disease should likely be looked at as a standalone diagnosis.

“Take a really good history, examine your patients properly, make sure you understand what the other things are that could be driving leg swelling and you’ve eliminated those”

“Is it a worthwhile measure at all because there are so many causes of swelling?” O’Sullivan added. “I think if the debate today had been ‘is stenting indicated in or is there evidence to support stenting for C5 and 6 patients,’ I think the result would have been very different.”

O’Sullivan concluded by saying that he “firmly believes” stenting is the right choice of action for treating C5 and C6 patients. “Those patients really need a stent, because their ulcers are horrible and we spend our whole lives trying to avoid patients getting ulcers.”

“I think we can agree that the end result of today’s debate is, ‘we need more data’ in this group,” Murphy stated as the conversation came to a close.

“W

e’re going to be discussing one of the most interesting debates from the Charing Cross (CX) International Symposium venous session,” Murphy began, on the role of treating NIVLs for advanced disease C3 to C6.

The roundtable video discussion covered an earlier debate between O’Sullivan and Steve Elias (Englewood, USA), director of the Center for Vein Disease at Englewood Hospital, which centered on the motion “treatment of [NIVLs] in C3–C6 disease is supported by the clinical evidence”.

“I think the difficulty is conflating C3, 4, 5, and 6 disease into one group,” Black said. He went on to say that when dealing with C6 disease, there are few people who would argue against trying a stent. However, for patients who only have “a swollen leg at C3,” that’s where the debate lies.

“I think that’s the difficulty really, because a lot of patients now are having stents for what I would regard as dubious indications,” O’Sullivan stated. “It’s an easy thing for a doctor to put in a stent.” Though, O’Sullivan continues to say that putting a stent into a patient is not always the right thing to do, at least when beginning treatment.

When dealing with C6 patients who have healed ulcers, O’Sullivan agrees, “a stent is a very worthwhile thing to do.”

Murphy agreed, saying that, while some patients who suffer from C3 venous disease do benefit from receiving a stent, “it’s a difficult patient group to work through.”

Black stated that, what people need to understand is that “all swelling, to some extent, is lymphedema” and that the “lymphatics start to fail”.

“Once the lymphatics stop working, the patients don’t recover. So even in patients who have got venous hypertension driving their leg swelling, that is from a May-Thurner or NIVL lesion, stenting it may not improve the situation because it may be too late,” Black stated.

Murphy responded, stating that

“setting patient expectations is one of the things that is important in that group.” She then continued, posing a question to O’Sullivan and Black. “Do you guys have some advice for people who are treating these patients and trying to sort through this group of difficult to diagnose patients with edema?”

O’Sullivan was first to answer, saying that imaging is an important factor. “I think you want to be comfortable with your imaging,” O’Sullivan began. “You want to be critical of your imaging as well, because imaging will tend to overcall a stenosis in my view.”

He also mentioned how intravascular ultrasound (IVUS) has recently been used and has benefits. O’Sullivan

STEPHEN BLACK

and is for life.

Black agreed with O’Sullivan, “I think those are all excellent points,”

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June 2024 / Issue 18

Trial Results

Prosthetic valve implantation shows “vast” improvements in deep chronic venous insufficiency “The surgical challenges of repairing deep venous reflux have been present for more than a generation. It is worth reflecting on the fact that this new technology has made the majority of patients vastly better,” were the words of principal investigator David Dexter (Norfolk, USA) who presented podium-first efficacy results from the Surgical Anti-reflux Venous Valve Endoprosthesis (SAVVE) trial at the Charing Cross (CX) International Symposium 2024 (April 23–25, London, UK).

THE TRIAL EVALUATED THE LONG-TERM efficacy of the VenoValve (EnVVeno Medical), a surgically implanted replacement venous valve for patients with deep chronic venous insufficiency (CVI). “These patients are the most severe of the severe,” Dexter detailed of their patient demographic, noting the trial’s inclusion of patients with Clinical, Etiological, Anatomical, Pathophysiological (CEAP) classifications between 4b and 6. He described that the “vast majority—around 60%—of these patients have active ulcers, and 70% of these ulcers had been active for at least a year.”

Dexter told delegates that a total of 69 patients were enrolled, 97% had a successful valve implantation, leaving two patients with veins that were “too small or diseased” and so were reported as technical failures. The researchers then split the cohort into two subgroups defined by clinical improvement of revised Venous Clinical Severity Score (rVCSS) by ≥1, and clinically meaningful benefit with an rVCSS improvement of ≥3.

At 11-month follow-up, 65 (94%) patients showed clinical improvement of ≥1 and 50 (72%) presented clinically meaningful benefit of ≥3. “When we separated these two groups out,” Dexter said, “in the 50 patients who were meaningfully significant we saw a significant rVCSS drop, but the patients who weren’t

One-year results for synchronous anterior accessory saphenous vein ablation hold up Twelve-month results from the SYNCHRONOUS trial, which is evaluating the role of prophylactic anterior accessory saphenous vein (AASV) ablation for the prevention of recurrent varicose veins, showed superiority among the group of patients whose AASV was ablated at the same time as their great saphenous vein (GSV), as opposed to those patients who underwent ablation to the GSV only.

TOBIAS HIRSCH (HALLE, GERMANY) presented the data during a podium first in the Venous & Lymphatics Controversies session at the Charing Cross (CX) International Symposium 2024 (23–25 April, London, UK).

Some 13.7% of untreated AASVs larger than 2mm and 4.8% of those smaller than 2mm showed reflux after a year, while 0.9% of AASVs in the treatment group did so, Hirsch said.

The multicentre, prospective, controlled study enrolled 1,173 patients between February 2019 and April 2022, with half of the patients in group A (GSV only) and

meaningful didn’t get worse,” Dexter noted.

“The data presented shows that, for patients experiencing a clinical meaningful benefit rVCSS improvement of ≥3 points, the overall average rVCSS improvement was 8.46 points, including 9.29 points for patients at the two-year milestone, 8.08 points for patients at the oneyear milestone, and 8.71 points for patients at the six-month milestone.

All rVCSS evaluations were based on the patient’s most recent clinical visit, compared to baseline, for a weighted average of 11 months following VenoValve implantation for the clinically meaningful benefit patient cohort.”

Recording rVCSS and pain (Visual Analog Scale [VAS]) scores at six, 12 and 24 months, Dexter stated that scores improved through each stage of follow up. rCVSS showed a 8.71-, 8.08-, and 9.29-point

half in group B (GVS plus AASV).

The cohort is being followed out to five years.

Hirsch and colleagues are assessing the impact of synchronously treating the AASV Tobias Hirsch to prevent recurrent varicose veins, with secondary endpoints including complication rate, postoperative pain intensity, as well as quality of life.

“When a preventive ablation of the AASV is being considered, it can be stated that there is no increased rate of side effects,” Tobias said.

“Compression therapy after endovenous laser ablation leads to significantly fewer symptoms compared to no compression.

Therapy duration of up to 14 days was found to be the most effective regime.”

“Compression therapy after endovenous laser ablation leads to significantly fewer symptoms compared to no compression” TOBIAS HIRSCH

improvement, and average VAS score was recorded as 1.78, 2.05 and 2, respectively, in all patients.

At 12-month follow up, quality-of-life and venous symptoms were also reported, VEINES-QoL and VEINES-Sym scores showing a 33% and 39% improvement.

“Overall, the VenoValve is a safe and effective surgery for the treatment of symptomatic patients with deep CVI,” Dexter said, concluding his presentation. Then, during panel questions, session moderator Manj Gohel (Cambridge, UK) highlighted the technical failure during valve implantation and whether this may lower efficacy in women with small veins.

“Clinically, on table, the vast majority of failures occurred preoperatively, and this was not based on gender. It’s really based on preexisting post-thrombotic syndrome that we didn’t identify on duplex,” Dexter responded.

Closing out the session, Gohel thanked Dexter and commented: “People have been trying to do this for decades. In terms of clinical data, this is as good as we’ve got with implanted valves. This research is very exciting.” Dexter stated that, although the VenoValve is currently DAVID DEXTER investigational only, they hope with US Food and Drug Administration (FDA) evaluation of their endpoints, the device can be commerciallyimplanted soon.

“Overall, the VenoValve is a safe and effective surgery for the treatment of symptomatic patients with deep CVI”

Women and Black patients less likely to receive catheter-based treatment for pulmonary embolism New data from the REAL-PE analysis investigated catheter-based pulmonary embolism (PE) treatment, showing women and Black people were less frequently treated with minimally invasive therapy compared to men or non-Black patients. The results were presented at the Society for Cardiovascular Angiography & Interventions (SCAI) 2024 Scientific Sessions (May 2–4, Long Beach, USA).

Ultrasound-assisted catheter-directed thrombolysis (USCDT), a common invasive treatment for PE, enables deeper penetration of the clot-busting medication, restoring normal blood flow faster.

Mechanical thrombectomy (MT) has been shown to reduce thrombus burden and pulmonary artery pressure (PAP) and to improve right ventricular (RV) function in patients with high-risk or intermediate-high-risk PE. REAL-PE analyzed data from patients within the Truveta database diagnosed with PE and treated with USCDT or MT for PE. Characteristics including race, ethnicity, age, sex, comorbidities, and prior diagnoses were assessed to investigate their association with the treatment used. Of the more than 430,000 patients diagnosed with PE, about 2,000 patients analyzed were treated with one of the invasive therapies. Women or Black patients were less frequently treated with invasive therapy than men or nonBlack patients.

“Although this data demonstrates the value of real-world data in the assessments of new technologies in which randomized data are not always available, there is still work that needs to be done to evaluate the current utilization of advanced therapies for PE in underrepresented patient populations,” said Sahil A. Parikh (New York, USA), lead author of the study.

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June 2024 / Issue 18

Conference Watch IVC 2024

Choosing the right stent for the right situation

Muck reported.

Muck then turned to the Zilver Vena stent and a post-thrombotic syndrome patient who had an iliofemoral deep vein thrombosis (DVT) during Patrick Muck (Cincinnati, USA) provided a state of the venous stent landscape pregnancy: Nine months after giving during the 2024 International Vein Congress (IVC; April 18–20) in Miami, USA. birth, “I put a 16, 60 Zilver Vena in,” he described, reflecting that, today, he he TriHealth vascular surgery market leader [among venous would place a longer one. program director ran through stents] is the Abre, based “I think both Abre and the key differences between on the number of cases Zilver Vena have data in a the venous-specific stents currently throughout the USA [where subgroup analysis looking at available and how he goes about the Abre is used].” the stent across the inguinal selecting which one to deploy in Muck outlined a ligament, and, suffice to say, specific scenarios. particular scenario during that the Zilver Vena is very Within the last four years, the which he deployed the Abre Patrick Muck efficacious, not only in the iliac Venovo (Bard), Vici (Boston Scientific), in a patient who had a history segment but also in the common Zilver Vena (Cook), Abre (Medtronic) of varicose vein surgery decades ago. femoral areas,” Muck added. and Duo (Philips) venous stents have all When the patient saw Muck, multiple Meanwhile, a case involving the been approved for use by the US Food issues needed to be addressed, and, Venovo stent, which Muck described and Drug Administration (FDA). discovering a femoral vein occlusion, as having “excellent patency at three “I’ve been fortunate enough to use Muck and his team, using an RF wire, years in industry sponsored trials,” saw all of the [currently available stents on placed the Abre stent, with the patient he and his colleagues treat a patient the market] besides the Duo so far,” doing well several years down the road with C4b disease who had been offered Muck told the audience. “Likely the following the intervention, superficial intervention. “Six weeks

T

When are lymphedema pumps the answer?

During IVC 2024, Brajesh Lal (Baltimore, USA) gave a presentation focusing on when he believes is the best time to use lymphedema pumps and nonsurgical interventions for treating lymphedema.

LAL BEGAN HIS PRESENTATION BY POSING a question to the audience, “What is the lymphatic system, and what is lymph?” he asked. “The lymphatic system is, in many ways, a parallel system to the venous system. This is a very important fact to keep in mind as we walk through this talk and when we walk through treating our patients.”

He also reminded the audience that the lymphatic system transports a large amount of fluid through the body. In fact, your lymphatic system transports about 20 liters of plasma into capillary walls every day.

While primary lymphedema is rare, affecting just one in 100,000 individuals in the USA, secondary lymphedema is the common cause of the disease, affecting about one in 1,000 people in the USA. “There are two groups of patients in particular who suffer from secondary lymphedema in the Western world,” Lal stated. “Breast cancer surgery patients and [patients with] chronic venous insufficiency.”

Lal then continued by discussing how vascular surgeons get into trouble when it comes to lymphedema.

“There’s plasma that exudes from the arterial end of the capillary into the intersection, most of it travels back into the venous end of the capillaries and into the venous system, a little bit goes into our lymphatic system,” Lal explained.

“If you have primary lymphatic disease, you’ve got problems on the venous end. There’s less fluid draining through the venous system, more dependance on the lymphatic system, and you end up with interstitial fluid collection.”

The lymphatic system and venous system play off of one another, which can both help and hinder you.

Lal continued by saying that the basic principles of

lymphatic management is to increase pressure on the affected areas to remove fluid and augment drainage back into the venous system.

“There are a whole host of non-proffered approaches you can take,” Lal said. “Most important and primary are position, elevation of the limb, exercise if you’re dealing with low extremity edema which is what most of us will be dealing with, and activating the calf muscle pump.”

Lal also stated that breathing augmentation can be an important factor in treating lymphedema. If patients can be trained to use diaphragmatic breathing for a few minutes every couple hours, they will be augmenting, for a few minutes, the venous fluid.

Lymphatic pumps

“Massage, force and compression garments, and, what I’m talking about,” Lal continued, “how do pumps fit into all of this?”

Brajesh There are numerous options for pumps Lal on the market, including nonsequential pumps and pumps that provide both sequential and segmental compression. One of the more recent pumps to be introduced is non-pneumatic pumps, which can change its confirmation and creation suppression sequentially.

One of the biggest issues with pumps currently is

“If you have primary lymphatic disease, you’ve got problems on the venous end. There’s less fluid draining through the venous system, more dependance on the lymphatic system, and you end up with interstitial fluid collection” BRAJESH LAL

after undergoing ablation, there was no improvement and the patient was offered the Venovo stent,” he said.

“What I like about all these stents is the thumb wheel for the Venovo and the Abre, and the pinch-and-pull for the Zilver Vena, which means you can place it precisely where you need to.”

The Duo stent, recently approved by the FDA, has emerged as “very flexible and very strong,” Muck continued. “At the end of the day, when it comes to placing [stents], you don’t want one that’s too short, because, if it doesn’t lock in, it may migrate. You don’t want one that’s too wide because, if it’s too wide, then, not only can you end up with pain in the short term, but perhaps this effect as well.

“Ultimately, there’s no headto-head,” he added. “You have to individualize each patient based on their scenario as well as their IVUS. Then you can decide which stent is best for you.”

that there are numerous guidelines that all claim to promote best practices. The issue continues in that, though they promote best practices, they are “limited by a lack of standard descriptions, a standard way of providing their recommendations, and, of course, a limited quality of the evidence available,” Lal stated.

“I want to be very careful separating out where there is evidence and where there isn’t, and where there is opinion,” Lal told the audience. “All guidelines recommend an initial decongestive therapy followed by maintenance decongestive therapy.

However, evidence for this kind of approach has not been tested in any highly-quantitative manner. Though the recommendation was strong.”

All guidelines also recommend elevation, exercise, and compression garments, though the guidelines varied in how they express their recommendation.

Lal explained that he would be referencing the guidelines created by the American Venous Forum (AVF), “which is essentially a strong recommendation based on either moderate, moderate-good, and very good quality data.

“Manual-lymphatic draining or massage has been given various grades when the level of evidence is modest,” Lal continued. “Pump-assisted compression, however, generally gets a low grade recommendation as well as a moderate grade in terms of the evidence available.”

There is another new form of lymphedema treatment arriving soon, non-pneumatic compression devices. They are currently being tested in a randomized trial and allow patients to continue daily activities.

Lal explained that he uses pumps, but “as an adjunct to elevation, exercise and compression. I use it in patients who have severe edema and very large limb volumes. Those who are limited in terms of their ability to ambulate, and those who cannot apply compression devices when they go through the maintenance phase.”

Lal concluded by saying that, while he muddles along in his practice with the limited information and resources currently available, choosing to use a pump will depend on the facilities available.

Issue 18 / June 2024

Conference Watch

JVS-VL papers go under the microscope On the final day of IVC 2024, Joseph P. Hart (Milwaukee, USA), Andrea P. Munive-Gnecco (Bogotá, Colombia), Luis E. Londoño-Mejía (Bogotá, Colombia), Nuttawut Sermsathanasawadi (Bangkok, Thailand), Juan Cabrera Garcia-Olmedo (Grenada, Spain), and Suandaram Ravikumar (Dobbs Ferry, USA), each presented abstracts focusing on venous and lymphatics set for submission to the Journal of Vascular Surgery: Venous and Lymphatic Disorders (JVS-VL). Each presentation was then critiqued by one of the attending vascular surgeons.

HART’S STUDY FOCUSED ON THE CURRENT outcomes of interventions to treat mixed arterialvenous ulcers. Hart and his team looked at the outcomes of ulcer healing on about 1,100 patients at 24 weeks, and then a second follow-up at one year.

“Isolated venous ulcer was defined as the presence of a venous ulcer with a normal TBI [toe brachial index], or toe pressure greater than 60,” Hart told the audience via video conference. “Mixed was defined as a venous ulcer in the presence of an abnormal TBI or the toe pressure was less than 60.”

Hart and his team found that combined arterialvenous and arterial interventions accelerate wound heling times when compared to venous interventions alone. This leads to decreased ulcer recurrence and improved long-term limb-based events in mixed ulcers.

The second abstract, from Munive-Gnecco and her team, focused on the outcomes of varicectomies in Colombia, a sub-analysis of the Colombian Surgical Outcomes Study (ColSOS).

“In low- and middle-income countries like Colombia, primary data on surgical procedures is scarce,” Munive-Gnecco told the audience.

She and her team looked at nearly 4,000 patients who were over the age of 18 receiving varicectomies, limb amputations, and other vascular procedures in different institutions across the country.

The study concluded that the secondary data

An in-depth look at the upcoming generation of venous devices During IVC 2024, Lowell Kabnick (Morristown, USA), ran through the latest venous devices currently in development.

HE STARTED WITH THE SCureClamp (Amsel Medical), an 18-gauge needle that can clamp blood vessels. The device has been tested in the Dominican Republica and is currently on its second generation.

“We learned that we really needed to improve the device. Now, with Gen 2, we’ve gone from two-handed to onehanded technique,” Kabnick stated. He also spoke about the trauma-application of the SCureClamp.

“A lot of our wounds are noncompressible, and that’s important and this could be a potentially lifesaving event,” Kabnick continued. The SCureClamp is expected to be available commercially near the end of 2024 or

from the current database, which is from 2015, underestimated the real burden in perioperative mortality across patients.

It also became apparent that the procedures being looked at in this study are not directly comparable, which means that drawing conclusions based on the crude data may not be conducive to informed public health decisions, the investigators reported.

“The intricate interplay of factors influencing outcomes in vascular surgery necessitates a nuanced understanding,” Munive-Gnecco explained to the IVC 2024 gathering. “Efforts should be directed towards refining analyses that consider the unique characteristics of each procedure.”

The third abstract, from Londoño-Mejía and his team, looked at gonadal vein embolization in pelvic congestion syndrome—a Latin-American center experience.

Londoño-Mejía and his team performed a singlecenter, retrospective case series study looking at patients who underwent coil embolization between 2019 and 2023.

Londoño-Mejía began by explaining that, in their research, the prevalence of pelvic congestion syndrome is up 30-40% in patients who suffer from chronic pelvic pain. He also explained that, since this study was done in Colombia, a low- to middle-income country, there is difficulty in access to surgery and challenges in consistent follow-up post-procedure.

first quarter of 2025.

“Let’s shift a little bit to another technique that is mechanical only, nonthermal, and non-chemical. It’s called InVera,” Kabnick said. InVera (InVera Medical) is a medical device treatment for all chronic venous disease patients that, InVera Medical says, is lessinvasive, effective, pain-free, and faster than other, similar devices.

“The device is basically a coil,” Kabnick explained. “You insert the catheter 2cm below the junction, and you’re going to pull it back, and then you can repeat the first 10cm as well.”

As for the clinical results of InVera, “pre-clinical results were good. There were five animals and 10 lateral saphenous veins. [There were] nine complete occlusions and one partial occlusion. There were no adverse effects.”

Moving on from InVera, Kabnick brought a question to the audience: “Can we convert a thermal operation into a really non-thermal operation with this advent?” he posed. “This is a device called Solutio (MedVasc).”

With the Solutio device, “an RF catheter or laser-fiber will be inserted into the channel and the needle will be used for tumescent, so internal and

Londoño-Mejía concluded by stating that coil embolization results in successful improvement of patient symptoms, although objective measurements are needed in future research. More robust studies are necessary, including direct comparisons between different techniques, he added.

The fourth abstract, presented by Sermsathanasawadi, focused on the effectiveness of early cyanoacrylate closure and compression therapy alone in the healing of venous leg ulcers caused by superficial vein reflux in a randomized controlled trial.

Sermsathanasawadi’s presentation won a monetary prize along with a JVS plaque.

Sermsathanasawadi and his team defined the primary outcome for this study as complete reepithelialization of all ulcers on the leg with no dressing required. Ulcer wound size was evaluated every four weeks until the 24-week mark.

The study concluded that the rate of ulcer healing at 24 weeks was comparable between compression therapy alone and compression with cyanoacrylate glue; that cyanoacrylate glue had a higher rate of ulcer healing at 50 days than the compression only.

“Historically, foams have been considered statistical collections of bubbles.

This paradigm leads to the perception that you can interact with one bubble without changing the rest of the arrangement” CABRERA GARCIA-OLMEDO

external.

Tumescent anesthesia will be given, and you’ll pull [the device] back,” Kabnick said.

“You’ll have Lowell a whole area Kabnick anesthetized.”

“If we look at comparisons of tumescent anesthesia, obviously this is going to cause less pain,” Kabnick explained. “The point of fact is that in trial, it really did.”

The pain scores for patients using the device was low in the study, and the catheter was reported as safe and easy to use.

“They’re going to be doing clinical studies momentarily in the USA as well as in Europe,” Kabnick told the audience.

Kabnick then moved on to discuss what he called a “buzzword.”

“We’ve been hearing about highintensity ultrasound for a number of years,” Kabnick said. “It’s now starting to spread a little bit. It’s in Germany, it’s in Italy, it’s in Czech Republic, and now in the USA as a trial.”

“Essentially this is a thermal unit,”

Kabnick explained. “Then there’s a cooling membrane, which is disposable, for the company’s advantage. Looking at this, you can see that it’s really kind of a process of looking at ultrasound and focalizing the beam to the target area.”

Kabnick then went on to discuss how, with the ever-rising usage of artificial intelligence (AI) across industries, if AI could be trained to use the device, the time of procedure would drop drastically.

He referred to a study that looked at the usage outcomes of high-intensity focused ultrasound (HIFU), HIFU with foam sclerotherapy immediately after procedure, and HIFU with delayed foam sclerotherapy. The results showed that, with HIFU only at eight weeks, there were eight out of 10 successful closures, or 80%.

“At one year, 40%,” Kabnick continued. “Results of HIFU plus foam sclerotherapy at the same time showed 100% successful closure [immediately post procedure]. At one year, 88% successful closure. HIFU plus late foam sclerotherapy, successful closure was 82% [post procedure], and then 91% successful closure [at a one year follow up],” Kabnick said to the audience.

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June 2024 / Issue 18

Interview

PROFILE

GLORIA SALAZAR

“There are a lot of patients walking out there who are not being treated. So you can only imagine the impact that we can have as specialists to be able to improve those patients’ quality of life,” Gloria Salazar (Chapel Hill, USA) tells Venous News while detailing some of her most memorable patient cases. In this interview, Salazar, the vice chair of health equity & community engagement and associate professor at the University of North Carolina (UNC) Department of Radiology, sat down to discuss her history in medicine, the clinical trials she’s currently working on, and what she would tell prospective medical professionals.

Why did you pursue a career in medicine?

Ever since I was a little girl I wanted to be a doctor—it was between that and being an engineer. When I became a teenager, I had a strong desire to be part of Doctors Without Borders, though that never happened. That desire pushed me to have a career in medicine.

I also visited my uncle in the USA when I was a teen. We were at a social event and a doctor friend of my uncle started talking to me about my interest in medicine. He was the first person to tell me that I should consider applying for the United States Medical Licensing Exam (USMLE).

I had early exposure to research when I was in medical school. But, back in Brazil, you have to do a big test and then get accepted into the specialty of your choice. I was really torn because I liked everything––I wanted to do surgery, I wanted to do orthopedics, I wanted to do everything, really. I decided to go for radiology, because radiology encompassed all different specialties.

After I finished my residency in Brazil, I got an opportunity to come to the USA to work as a research fellow at the Beth Israel Deaconess Medical Center in Boston. I got to work with vascular interventional radiology and fell in love with it. The rest is history.

Who have been your career mentors, and what is the best advice they gave you?

I have been blessed to have several mentors throughout my career, too many to name in this article, but I wanted to specifically mention Salomao Faintuch, Elvira Lang, and Maureen Kohi for giving me the opportunity to make a positive impact in society––for which I will be forever grateful my entire life. Stephan Wicky Van Doyer, Greg Walker, Chris Athanasoulis and Art Waltman for being part of my early career stages that shaped my clinical practice and principles in the moment in my life that I most needed support.

I had amazing mentors in radiology when I was in Brazil including the Department chair, Dr Jacob Szejnfeld. I’m still connected with my mentors, and they have become my friends over the years. I have been very blessed to have so many people helping me in my career, indirectly or directly. Also, I am very thankful for my colleagues—vascular surgeons and interventional cardiologists—who I worked with at Mass General Hospital (MGH; Boston, USA).

Now at UNC, the team that we’ve formed really enhances knowledge, research, and

patient care. There are so many people to name. Over the years, I’ve created a good group of connections and people that I can rely on that have helped me and supported me.

What has been the most important development in the venous space over the course of your career?

I think the most important development is that we’re actually paying attention and that there is more awareness of this disease. When I was a fellow we were trained in venous disease, but it was heavily focused on arterial disease. You could rotate into a venous center, but we did not have a robust understanding of the disease process.

Back then we did not have pulmonary embolism (PE) response teams, those came out when I was at MGH in 2012. I think that was a huge development, not only for the treatment of PE, but also for the value of having multidisciplinary teams. I think that’s where we really show how we can make things happen if we work together.

There are other things that have really improved over the last 15 to 20 years. I think we know much more about what we’re doing with our patients and how we do it. I think there is a new understanding that there’s definitely no one-size-fits-all for venous disease in terms of thrombogenic pathways and patient presentation. Really, I think the last 20 years have been fundamental for us to understand where we organize ourselves as specialists.

We also have clinical trials that have started in the venous space that were not even thought of 20 years ago. I think that is the beauty of the evolution and advancement of venous disease.

I would say that, in my view, that truly is a testament to collaborative work. There’s no way you can get to this level of advancement without collaboration.

Can you outline some of the trials that you’re currently involved in?

The major trial that I’m currently involved in is the EMBOLIZE trial, of which I’m principal investigator with Dr. Ronald Winokur. A critique of previous publications, and the major critique that leads to the lack of insurance coverage, is that previous studies were unable to select a homogenous patient population. The other critique was, in order for you to really establish that embolization does help reduce chronic pelvic pain in those patients, you need to compare it with an intervention or comparable procedure.

This study was not only to address what

FACT FILE CURRENT APPOINTMENTS Program chair of SIR 2025 Board of Directors of the IberoAmerican Society of Interventionism (SIDI) SPONSORED CLINICAL TRIALS Co-PI of EMBOLIZE trial EDUCATION MD Universidade Federal de São Paulo Vascular Internventional Fellowship, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston

has not worked in the past, but also to answer a specific research question, which is whether embolization of gonadals and internal iliac veins do help decrease venous-origin chronic pelvic pain.

With that definition, we also need to exclude patients with other gynecological conditions, because we know chronic pelvic pain is a broad umbrella of different diagnoses.

We also devoted a lot of time in our steering committee for the EMBOLIZE trial to develop a protocol that is standardized and is done the same way for everyone.

The patients in our study should not have any obstruction diagnosed by imaging or extra pelvic symptoms, should not have had any surgical interventions in the past, and should not have had any other diagnosis for gynecological causes of chronic pelvic pain.

Our endpoint is visual analog score and differences in the control and in the intervention group. Essentially, patients are going to be randomized to either procedure or venography alone. They’re all going to be blinded as to what intervention they will have.

For the control group, it will be a venography procedure without intervention and without embolization. This is so we can evaluate the placebo effect and also evaluate the differences.

Then we’re going to follow up for the inputs we’re testing for. We’re also looking for quality-of-life questionnaires and specific questions about different symptoms that can overlap with pelvic pain of venous origin.

With that, we’re going to follow up with patients both in person and electronically.

Then, at six months, we will unblind those patients to what they were treated for and we’ll offer the embolization to the group that was treated with venography alone.

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

I think some of the trials that are underway are needed, like the trials that are currently happening in the deep vein thrombosis (DVT) space and the PE space. Now, with the EMBOLIZE trial, I think we still lack understanding on what thrombogenic factors influence outcomes in stenting and in different interventions that we do. But I think this is a more complex question to answer.

I do think we’re going to learn much from the current trials. We also have innovations in valve technology with prosthetic valves being introduced.

I think what is needed is what we’re trying

Issue 18 / June 2024

11

alisonlang.com

Interview

to achieve as a group. When I say as a group, I mean societal groups internationally and nationally, showing how to coordinate those efforts and make sure we are moving this agenda forward in the most efficient manner.

I think this is a great start for future research, protocols that could be developed in the future, and in the venous space. I would say there’s still a lot to be researched, so I don’t think it’s going to get boring on the venous side.

We still have a lot to learn. We’re really just at the tip of the iceberg.

trip after we treated them. There are a lot of patients walking out there with diseases and they are not being treated. So, you can only imagine the impact that we can have to be able to improve those patients’ quality of life.

I also do a lot of obstetrics and hynaecology (OBGYN) work with high-risk obstetric patients. Every time I see those babies being born and the mom is not bleeding is a memorable moment for me.

Can you outline one of your most memorable cases?

You have to first ask yourself why you want to go into medicine. For me, and for many others that I talk to, it is helping the lives of patients. You can help the lives of patients in different capacities.

If you’re looking for a career in medicine, you need to look inside yourself and see what your core values are. If this career resonates with you, you should learn about it before you go into it. I would strongly recommend you talk to other physicians who are already in the

The most memorable cases are ones where the patient’s life is changed for the better, and I have so many of them, in particular with venous disease. I think that it is very rewarding to see a patient go from no quality of life to being able to spend time with their children and families. I’ve had so many stories of patients that could not go to Disney Land, for example, and they were able to make that

What advice would you give someone who is looking to start a career in medicine?

“There’s definitely no onesize-fits-all for venous disease in terms of thrombogenic pathways and patient presentation”

field how happy they feel about it.

It’s hard to talk about this without mentioning the burnout that we’re dealing with––not only in healthcare, but in life in general. So, please, choose a career that makes you happy. I think a career in medicine could be a career with high quality of life, depending on what you do and how you conduct yourself.

You can contribute to the wellbeing of humanity in different capacities, just think about which capacity you want to be in.

What are your hobbies and interests outside of medicine?

I love arts, music, and sports. I’m a big, big fan of soccer. I love going to soccer games and going to concerts and museums. I also love spending time with my friends and family, going to the beach, and playing golf with my son and husband.

A hobby that I have not continued, but did for a long time, is playing the guitar. I love music so much, but it’s been a long time since I’ve done that. Other than that, I just enjoy being in contact with nature.

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June 2024 / Issue 18

Lymphedema

Novel portable non-pneumatic compression device performed better than advanced compression devices in testing for lower extremity lymphedema During a presentation at the 2024 American Venous Forum (AVF; March 3–6) in Tampa, USA, a study that compared a novel non-pneumatic compression device with an advanced compression device demonstrated statistically significant disruption in limb volume that favored the former.

THE MULTICENTER, randomized, control crossover study’s primary endpoint was change in lymph volume from baseline, change in quality of life using the lymphedema quality of life tool (LYMQOL) validated qualityof-life scoring system, and treatment adherence during study period, presenter Todd Berland, director of outpatient vascular interventions at New York University in New York, USA, told those gathered.

The patients in the study were an average of 58 years old, and a majority of them were White women. Of the patients, there were “11 primary and 60 secondary lymphedema, 34 patients were unilateral and 37 bilateral,” and they had an average of

eight years since their diagnosis.

Berland outlined the non-pneumatic device at hand: the Dayspring (Koya Medical) device, battery-powered without a foot portion, which allows users to walk. The device also features components that “stretch and release, and fake or simulate a manual lymphatic massage experience,” he said. “Between the static compression that you get with the actual garment,” Berland continued, “stretching and elongating phenomenon, and the fact that you can walk with the device, and really activate that calf muscle pump, may account for what we see here in this study.

Now we compare this device to commercially available advanced pneumatic plug-inTodd Berland the-wall devices.”

The researchers looked at adult patients with primary or secondary lymphedema, looking for unilateral and bilateral patients, he told AVF 2024. “We had nine study sites with 121 patients consented. There were 22 screening failures, leaving us with 99 patients.”

The team randomly gave either the non-pneumatic device or advanced compression device to the patients.

“They used this for three months, and at the end of that three-month period we checked quality-of-life and limb-volume measurements. We then had them use nothing for one month, the washout period, to give us a new baseline. We rechecked limb volume and quality of life, and then the patients crossed over,” Berland said.

After the patients crossed over, they used the opposite device that they were originally given for another three-month

period. Measurements were taken of the patients’ lower extremities using a tape measure. Quality of life was also assessed at the end of three months.

Finally, patients were all given a diary to give their thoughts of the devices throughout the study.

The results of the study showed a “statistically significant disruption in limb volume favoring the Dayspring device,” Berland told the audience. “A 370mm volume reduction in this group compared to an 83mm reduction in advanced pneumatic compression.”

“When we look at the foot, there was actually no statistical significant difference here. Both devices and subgroups trended toward improved diameters and circumference of the foot,” he said.

The quality-of-life questionnaire also favored the Dayspring device, with the function, appearance and symptoms being rated as better than the advanced compression device. Even when it came to how committed the patients in the study were, the Dayspring device had an adherence rate of 81% compared to the advanced pneumatic compression rate of 56%.

Finally, as to which of the two devices the patients preferred, “78% of patients prefer the Dayspring device compared to 22% for advanced pneumatic compression,” Berland said.

The study met both its primary and secondary endpoints, showing limb volume change from baseline, change in quality-of-life, and treatment adherence.

STEVECO

12 MONTH FOLLOW-UP RESULTS OF AN INDEPENDENT RCT* COMPARING VENOUS STENTING VERSUS CONVENTIONAL TREATMENT

Primary Patency 91,4 %

Assisted Primary Patency 94,2 %

Mean VEINES-QoL values over time**

Mean VEINES-Sym values over time**

54 52 50 48 46 44 42 40

Control

Baseline

3 months

sinus-Venous

12 months

Control

54 52 50 48 46 44 42 52

Baseline

3 months

Figure 1 & 2: Mean values for VEINES-Sym and VEINS-QoL at baseline, 3-month and 12-month **Exact data on file. Graphic does not represent full decimal points

sinus-Venous

Secondary Patency 97,2 %

sinus-Venous

Qol score

Regression coefficient

95 % CI

p - value

VEINES-Qol

8,07

3,04 – 13,09

0,002*

VEINES-Sym

5,99

0,75 – 11,24

0,026*

12 months Table 1: Comparison of change in VEINES QOL/Sym (from baseline to 12 months) between the stent group versus the control group

* Data on file at optimed; Shekarchian, Soroosh et al. "Quality of Life after Stenting for Iliofemoral Venous Obstruction:

• Clinically meaningful: ≥4 points for VEINES-QOL/Sym Kahn, et al. JVS 2020

A Randomised Controlled Trial with One Year Follow Up." European journal of vascular and endovascular surgery:

• The regression coefficient indicates the difference in change score from

the official journal of the European Society for Vascular Surgery, S1078-5884(23)00610-X. 28 Jul. 2023, doi:10.1016/j.ejvs.2023.07.044

baseline to 12 months between the intervention group vs the contro group

Issue 18 / June 2024

Artificial Intelligence

VTE

Adoption of AI into workflow associated with faster time to assessment of PE patients An abstract presented at the 2024 American Venous Forum (AVF) annual meeting (March 3–6; Tampa, USA) revealed that, in the treatment of patients with pulmonary embolism (PE), the implementation of artificial intelligence (AI) software has been linked to a shorter time to assessment.

AT THE MEETING, JACOB SHAPIRO, shared this and other key findings from a review of patients diagnosed with PE at a single center over a six-year period.

Shapiro, a resident at TriHealth in Cincinnati, USA, and colleagues outline in their abstract that the serious and potentially life-threatening nature of PE necessitates a “streamlined PE workflow with timely assessment and initiation of treatment” to potentially improve a patient’s chance of survival. They add that AI has been increasingly used in healthcare to improve clinical efficiency.

The authors detail that, in October 2022, TriHealth implemented an AI-powered parallel workflow tool designed to automatically detect and triage patients with suspected PE. The aim of

the study, they share, was to evaluate the Speaking ahead of AVF, Shapiro clinical impact of AI software on time to stated that “further research is needed to assessment, time to anticoagulation, and determine if long-term patient outcomes patient outcomes at the institution. are impacted by this technology.”

Shapiro et al reviewed 150 patients On the learning curve with this AI diagnosed with PE between January software, Shapiro remarked that it is “very 2017 and July 2023, retrospectively minimal.” He explains: “The interface for collecting data on these patients prior to AI Jacob Shapiro reviewing CT [computed tomography] implementation and comparing it against scans is very intuitive and the chat feature those of PE patients following AI implementation. is easy to navigate. The patient’s lab values are also The researchers looked at scan-to-assessment time, automatically imported and obviously displayed.” scan-to-alert time—which they note was used as Shapiro commented that overreliance on AI a surrogate for scan-to-assessment time following could be a drawback of the technology. However, he AI implementation assuming best practice—time emphasized his overall opinion that, as an adjunct to to anticoagulation administration, Pulmonary an expert reviewer, there are “no real downsides.”

Embolism Response Team (PERT) activations, and in-hospital mortalities.

Shapiro reported at AVF that scan-to-alert time in the post-AI group of 45 patients was “significantly faster” than scan-to-assessment time in the pre-AI group of 113 patients. He added that anticoagulants were administered faster for post-AI cases with PERT activation compared to cases without PERT activation, and that in-hospital mortalities decreased from 8.4% (pre-AI) to 2.2% (post-AI), with all mortalities occurring in cases without PERT activation.

“Adoption of AI into our workflow was JACOB SHAPIRO associated with faster time to assessment of PE patients,” Shapiro and colleagues conclude in their abstract. They elaborate that, with an average AI alert time of under six minutes, AI “optimizes Specifically, he gives the example of the ability to standard of care by promoting quicker triage.” look at scans in views other than axial (i.e. coronal Furthermore, they note that the combined benefit or sagittal) as a benefit for reviewers. of AI and PERT activation was highlighted by Giving a wider endorsement, Shapiro notes that it faster anticoagulation administration and decreased has already been widely adopted by neurosurgeons mortality in their sample. “These findings suggest a for strokes and that his institution has been using it link between earlier anticoagulation and reduced risk for PE for over 18 months. “We are already seeing it of mortality,” they write. integrated into clinical practice,” he says.

FDA clears AI-driven detection tool for pulmonary embolism Medical imaging artificial intelligence (AI) company Avicenna.AI has announced 510(k) clearance from the US Food and Drug Administration (FDA) for its CINA-iPE AI-powered tool that detects incidental pulmonary embolism (PE) during routine computed tomography (CT) scans.

THE CINA-IPE ALGORITHM identifies lung blood clots detected during routine CT scans for entirely different health conditions. Scan types may include full-body scans, scans of the chest, abdomen and pelvis, and scans of the thoracic area, along with the abdomen and pelvis. The tool was validated on 381 CT scans—performed for other clinical indications than for PE evaluation—acquired on 39 different scanner models from five leading manufacturers, “achieving excellent sensitivity and specificity,” according to Avicenna AI. “From day one, we have been committed to validating our AI tools on every type of CT scanner,” said Yasmina Chaibi, clinical affairs manager at Avicenna.AI. “In our validation studies, CINA-iPE achieved excellent sensitivity and specificity, demonstrating its ability to provide effective prioritization and triage on

routine CT scans performed for other clinical indications than pulmonary embolism suspicion.”

Avicenna.AI also received clearance for CINA-ASPECTS, an AI tool that assesses stroke severity, automatically processing noncontrast CT scans and calculating the “ASPECT” score. The “ASPECT” score is a topographic scoring system used to quantify the severity of a stroke from a brain CT scan.

“From day one, we have been committed to validating our AI tools on every type of CT scanner” YASMINA CHAIBI

“The interface for reviewing CT [computed tomography] scans is very intuitive and the chat feature is easy to navigate. The patient’s lab values are also automatically imported and obviously displayed”

The first FDA-cleared tool from Avicenna.AI in the category of computer-aided diagnosis (CADx), the CINA-ASPECTS identifies abnormalities in scans and provides a severity assessment. It computes a heat map, indicating the probability of hypodensity and sulcal effacement in the brain, displays a list of infarcted regions, and provides CT images to compare the right and left hemisphere.

“The validations and multi-readermulti-case studies we conducted highlighted that CINA-ASPECTS not only obtained outstand standalone performance,” Chaibi added, “but also demonstrated that its adjunctive use significantly improved clinicians’ accuracy in the assessment of ASPECTS region, compared to the conventional use of non-contrast computed tomography (NCCT) images alone.”

“We are delighted to launch CINA-ASPECTS to the US market, marking a significant milestone as our first CADx product receives FDA

clearance,” said Stéphane Berger, regulatory and quality manager for Avicenna.AI. “We take pride in being at the forefront of CADx solutions, being the first AI company supported by thorough clinical validation and a rich repository of real-world clinical data, which ensures compatibility across all manufacturers and platforms.”

The CINA-iPE and CINAASPECTS are just the latest AI tools from Avicenna.AI, others include CINA-ICH for the automatic detection of intracranial hemorrhages, CINALVO for large vessel occlusions, CINA-AD for aortic dissection, and CINE-PE for pulmonary embolisms.

“The clearance of CINE-iPE and CINAASPECTS marks a significant milestone in our mission to strive for excellence in advancing patient care,” said Cyril Di Grandi, co-founder and CEO of Avicenna.AI. “These achievements stand as a testament to the unwavering commitment of our team.”

13

June 2024 / Issue 18

Study Results

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Kurt S Schultz

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“Our hypothesis was patients undergoing iliac vein stenting later in the day would have smaller stents placed compared to those who had stents placed earlier in the day”

DO®

was 64, with 30 being in the early group and 34 in the late group.

Of the 64 patients, the mean age of the patients was 52 years old and 48 patients were female.

Since these patients are typically fasting starting at midnight the day of their surgeries, “patients who are having elective procedures later in the day are likely to be more dehydrated,” Schultz told the audience. “So, our hypothesis was patients undergoing iliac vein stenting later in the day would have smaller stents placed compared to those who had stents placed earlier in the day.”

The study found that later start times, which correlate with longer fasting times and more dehydration,

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SCHULTZ STATED THAT, WHILE iliac vein stenting is a viable treatment option, “inappropriate sizing of venous stents can have catastrophic complications, and there’s been a rise in reports of stent migration to the heart and lungs. Iliac vein size, as we know, depends on several factors, importantly the hydration status of patient but also BMI [body mass index] and whether the patient is prone or supine.”

The study that Schultz, Chaar and a multidisciplinary team of colleagues performed divided patients into two groups—those who received their procedures before 11 a.m. (early group) and those who received their procedures after 11 a.m. (late group).

The number of patients in the study

pain as compared to catastrophic complications such as a stent migration, Schultz responded by saying that his team have the data to look at those complications, adding, “I think that’s an appropriate next step.”

Importantly, Schultz and his team are developing a preprocedural hydration protocol, he concluded.

NAR

During the 2024 American Venous Forum (AVF) annual meeting in Tampa, Florida (March 3–6), Kurt S. Schultz, MD, a general surgery resident at the Yale University School of Medicine in New Haven, Connecticut, presented findings from a study regarding how fasting duration prior to venography is associated with stent size in patients with iliac vein compression. This study was conducted under the mentorship of Cassius Iyad Ochoa Chaar, an associate professor of surgery in the Division of Vascular Surgery and Endovascular Therapy at Yale.

were significantly associated with a smaller stent size compared to procedures performed earlier in the day. “In conclusion, based on our linear regression we found that a nine-hour fasting duration was associated with an approximately 2mm decrease in stent size,” Schultz stated. “So, the longer fasting duration was associated with smaller iliac vein stent size.”

The secondary clinical outcomes supported the hypothesis, with the left common iliac vein and external iliac vein being larger in terms of surface area in the early group when compared with the late group. However, Schultz explained, “this didn’t reach statistical significance.”

Following his presentation, Schultz was asked about if there were any complications in patients due to the size of the stents. He explained that there have been no stent migrations in the series which would be the rare and feared complication to avoid.

When asked about whether the patients had chronic pain associated with the oversized stents, as there is a larger issue with chronic

ift

New study reveals how fasting prior to venography shows differences in necessary stent size

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14

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08.05.24 16:53

Issue 18 / June 2024

Trial Results

15

DEEP VEIN THROMBOSIS

Novel ultrasound-facilitated thrombectomy with microbubbles shows promise in acute porcine model for DVT treatment

the ultrasound catheter one centimeter every 45 seconds. I think we can do it faster than that.”

Total time for the procedure averaged 17 minutes, with nearly complete clot treatment achieved, Marston said, concluding that the in vivo testing showed that the SonoThrombectomy System significantly reduced thrombus burden while preserving vessel walls. “This is a novel combination of ultrasound, microbubbles, and tPA, which we think will lead to the ability to do single-session sonothrombolysis,” he added. “We’re planning to move to in-human [testing] by the end of this year.”

Evaluation of the safety and performance of a novel pharmaco-mechanical procedure for acute deep vein thrombosis (DVT) in two pigs demonstrated a significant reduction in thrombus burden and vessel wall preservation, data from in vivo testing reveal.

T

he SonoThrombectomy system thrombus creation. Complete vessel (SonoVascular, Inc.) was tested on occlusion was achieved in all veins with swine with thrombi in their iliac veins. a mean diameter of 11mm ± 0.9mm and a The study focused on establishing how mean clot length of 10.9cm ± 1cm. the system—composed of an ultrasound The thrombus was then crossed with catheter that delivers microbubbles a .018 wire and treatment was performed to induce microbubble-mediated through SonoVascular’s 12F sheath sonothrombolysis (MMS) alongside with MMS. a mechanical thrombus retriever and “The procedure is a two-stage effort,” aspiration sheath—would work in treating Marston said. “First, the sheath is inserted DVT without vessel trauma, blood loss, or via the femoral common vein to the a prolonged intensive care unit (ICU) stay. thrombus, which allows crossing with William A. Marston Results were presented during the 2024 an open-ended guidewire. We then cross American Venous Forum (March 3–6) in the thrombus, and pass the ultrasound Tampa, USA, by William A. Marston, professor of catheter up and down to break up the clot with MMS vascular surgery at the University of North Carolina and administration of the tPA [tissue plasminogen Hospitals in Chapel Hill, USA. activator]. Second, retrieval is conducted using an Safety was evaluated by a gross examination of the associated basket. With this protocol, we advanced treated vessels following necropsy of the animals to identify intimal injury or disruption.

“We’ve all used ultrasound before,” Marston told the audience, “but this is a new method of using ultrasound, and the key is that it adds the function of microbubbles. These microbubbles are excited by the ultrasound waves to produce specific effects within the clot that you are addressing. This is a sub-megahertz frequency ultrasound catheter.”

WILLIAM A. MARSTON Both pigs had fluoroscopies performed to evaluate the iliofemoral venous segments before and after

11mm ± 0.9mm

Complete vessel occlusion was achieved in all veins with a mean diameter of 11mm ± 0.9mm and a mean clot length of 10.9cm ± 1cm.

“This is a novel combination of ultrasound, microbubbles, and tPA, which we think will lead to the ability to do singlesession sonothrombolysis”

CLOUT registry: Interim two-year rates of PTS ‘significantly lower’ than those in historical DVT studies Rates of post-thrombotic syndrome (PTS) among deep vein thrombosis (DVT) patients treated with the ClotTriever thrombectomy system (Inari Medical) who are logged in the real-world CLOUT registry demonstrated “significant and sustained improvement” out to 24 months, according to interim two-year data recently delivered at the 2024 American Venous Forum in Tampa, USA (March 3–6).

THE RATE OF MODERATEsevere PTS at the two-year mark was reported as 7.3% among 228 patients included in the interim analysis, presenter David Dexter, vascular surgeon at Sentara Vascular Specialists

dataset in DVT since the ATTRACT trial. Patients had low incidence of independently adjudicated safety events related to re-thrombosis, with only 5% and 8.4% at 30 days and six months, Dexter reported.

“With third-party adjudication of all safety events in this robust, large dataset, ClotTriever has a strong safety profile,” said Dexter.

“And the longer-term results are suggestive of sustained benefit

in Norfolk, USA, told AVF 2024 attendees.

The overall rate of PTS in the interim ClotTriever device results was 19.9%.

PTS rates reported through a in CLOUT are critical window “significantly lower” than when longer-term those from historical DVT sequelae typically manifest in studies such as ATTRACT and CAVA, DVT patients. The low PTS rate that which reported moderate-severe PTS continues to improve over time is a rates ranging from 18–24%, he added. testament to the safety and effectiveness The interim results are the largest of wall-to-wall thrombus removal with prospective, multicenter two-year ClotTriever.”

10.9mm ± 1mm “The longer-term results are suggestive of sustained benefit through a critical window when longer-term sequelae typically manifest in DVT patients” DAVID DEXTER

June 2024 / Issue 18

Advertorial

16

THIS ADVERTORIAL IS SPONSORED BY OPTIMED

STEVECO trial catalyzes need for “a new era” of postthrombotic syndrome patient management Before the STEVECO trial, there were no randomized controlled trial data in the chronic disease space; in its wake, has come a more robust landscape to establish an evidence base: During the 2024 Charing Cross (CX) International Symposium (April 23–25, London, UK), Stephen Black (Guy’s and St Thomas’ NHS Foundation Trust and King’s College London, London, UK), Efthymios Avgerinos (Athens Medical Center and University of Athens, Greece), and Erin Murphy (Atrium Health’s Sanger Heart and Vascular Institute, Charlotte, USA) sat down with Houman Jalaie (University Hospital RWTH, Aachen, Germany), to discuss the STEVECO trial and how it provides necessary data on venous stenting for patients affected by chronic venous insufficiency.

T

he STEVECO (Stent versus conservative treatment in patients with deep venous obstruction) trial is a prospective, randomized, multicenter, 12-month trial comparing venous stenting using Optimed’s sinus-Venous stent to conservative treatment. The trial measured disease-specific quality of life (QoL), Venous Clinical Severity Score (VCSS), and patency in 63 patients who had either post-thrombotic syndrome (PTS) or non-thrombotic iliac vein lesions (NIVLs). The results of the study showed that symptomatic patients with deep venous obstruction who received the sinus-

Houman Jalaie, Efthymios Avgerinos, Erin Murphy, and Stephen Black at discussion table

Venous dedicated venous stent had significant improvement in QoL after 12 months. There was also a significant improvement in VCSS and the pain disability index.

To begin the roundtable discussion, Jalaie, senior author for the STEVECO trial, asked Black what the next steps are for bringing more evidence to the venous stenting field.

“That’s a great question,” Black said. “Obviously, you and your team have to be congratulated on performing this trial because there has been no randomized data in the chronic space before STEVECO, and I know the difficulties you had with running it. We

need data of some description, we need bigger registry data, and we work here on a project with the European Society for Vascular Surgery (ESVS) and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) to set up a European registry.”

Black praised the STEVECO trial, saying that it helps to establish more robust databases to support therapies that the vascular community is trying to offer patients.

Jalaie then turned his focus to Avgerinos, asking “what about Europewide efforts in terms of registries to augment the evidence base for venous stenting?”

“It’s an exciting time for the venous world, it’s an exciting time for ESVS,” Avgerinos said. “As we’re launching the ESVS venous registry, we’re going to get vein centers all around Europe to start entering data on deep venous intervention. We are also involving CIRSE to make sure that we get all the specialties in.”

Avgerinos continued, saying that one of other major goals of this registry is to help better assess the efficiency of venous procedures and the long-term follow-up that randomized controlled trials cannot currently give.

“The current ESVS guidelines on chronic venous disease were published in 2022,” Avgerinos stated. “That was just a little bit before the STEVECO trial came out, so it does not include the STEVECO trial. The guidelines right now include the fact that we can stent patients with iliac vein outflow obstruction when they have severe symptoms.” Avgerinos believes

that adding the knowledge from the STEVECO trial will help upgrade the level of evidence for chronic venous disease from a B to an A. “I think this will embark on a new era in the management of patients with post-thrombotic syndrome,” Avgerinos said.

Jalaie asked Murphy what could be done better in the future when it comes to patient recruitment, as the STEVECO trial struggled there.

Murphy responded, “Recruiting participants for randomized controlled trials has proven challenging, as we’ve seen across multiple studies.

While there is a demand for highgrade evidence, we need to consider whether additional randomized controlled trials are necessary. We now have the STEVECO data, extensive data sets from IDE stent trials, and numerous smaller single-center trials, all consistently showing that venous stenting is effective across patient subgroups. These studies universally demonstrate improvements in quality of life and venous functional outcome scores.”

Murphy continued, “I believe our next step should be trials focusing on real-world data across various specialties treating these patients. We need data that offers more insights into patient selection, identifying which patients benefit the most, and finding ways to reduce risks for higher-risk post-thrombotic patients.”

Black went even further, discussing how recruitment has plagued nearly every trial in the venous space. He specifically mentioned the C-TRACT

Issue 18 / June 2024

Advertorial

The sinusVenous stent, seen in these two images, is a highly flexible stent that does not sacrifice strength.

“Patients with deep venous obstruction who received the sinus-Venous stent showed significant improvement”

be optimized, if we do a trial of a technique that involves technical skill, ability, and a learning curve, and don’t do it when people have optimized how they deliver that treatment, you’re going to get a trial of a poor intervention against doing nothing, which is unlikely to give an outcome that is beneficial to patients or us,” Black added. “Technical success delivers optimal outcomes to the patients.”

When it comes to using technical tools to help select patients, Avgerinos says that above all else, the patient’s anatomy must be known.

“To be well prepared, to intervene, and to better communicate with our patients,

the stents patients receive need to be durable, especially in female patients who may, in the future, want to have children.

“We need to see the long-term durability for these treatments,” Black said. “Of course, we can only get that once these stents have been in people for a long time, so some of it has to be predicted.”

“We also have to work on the things that we’ve forgotten about in the drama around what is the next stent,” Black continued. “We need to maintain stents in patients and look after them. That comes with better drug therapy, potentially innovation around technologies that help us to look after stents for the lifetime of a patient, and we need to optimize that implantation

“I think this will “I believe our next “We’ve been trying embark on a new era step should be trials on several different in the management focusing on real-world fronts to make sure of patients with data across various that people are post-thrombotic specialties treating reporting to standard syndrome” these patients” outcome measures”

HOUMAN JALAIE

EFTHYMIOS AVGERINOS

ERIN MURPHY

STEPHEN BLACK

trial and the UK-based BEST-PTS trial, the latter of which was suspended due to recruitment issues.

“STEVECO was helpful in revising recruitment targets,” Black said.

“Because the data from your study allowed us to drop the numbers that we needed to recruit.”

“Probably the way to address recruitment is to look at novel trial designs that do not involve randomization of patients to try and get everybody into some form of prospective data collection,” Black continued. “Registries have their limitations, of course, but there are other options for trial design, particularly in the era of artificial intelligence (AI) that are now coming to the fore, which allow you to enroll

everybody regardless of treatment or place.”

Murphy emphasized the importance of standardizing data collection across trials, stating, “We need to ensure consistency in what we’re collecting. In reviewing those IDE trials, it became evident that they examined different patient groups and thought they were looking at the same conditions—PTS and NIVL—but the definitions varied across the trials.”

“I hope that we can get to a more standardized approach,” Black responded. “We’ve been trying on several different fronts to make sure that people are reporting to standard outcome measures.”

“When you touch again on aspects of all the trials that need to

we need to have good imaging,” Avgerinos said. “In today’s practice, I think imaging techniques have evolved.”

Avgerinos continued the conversation, explaining that while magnetic resonance venography (MRV) and computed-tomography venograms (CTV) are good, intravascular ultrasound (IVUS) will give the best imaging results. By combining IVUS with duplex and axial imaging, he said, you can decide which patients will benefit the most from specific procedures.

Moving towards the treatment of younger patients, Jalaie asked “How do we make sure to provide the best longterm treatment?”

Black answered first, stating that

phase of that stent.

Avgerinos spoke about anticoagulation, noting that there aren’t robust data regarding it, but “from what we know it seems that low molecular weight heparin, with its anti-inflammatory effects, may be beneficial in the early period after placing a stent.”

The roundtable discussion closed out with Jalaie asking the panel whether or not these procedures should be centralized.

“You have to do enough and do them often enough to become good, and that’s in the best interest of patients,” Black concluded. “Hopefully the data that we’re all generating can support that narrative as it has done for aortic surgery in the past.”

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18

June 2024 / Issue 18

Post-Thrombotic Syndrome

Study hints at long-term cost-effectiveness of CDT and PMT over oral anticoagulation for moderate and severe PTS During a presentation at the 2024 European Vascular Course (EVC; March 3–5) in Maastricht, The Netherlands, Anna Pouncey, a clinical research fellow for vascular surgery at Imperial College London in London, UK, presented findings from a study on the cost-effectiveness of early thrombus removal for acute iliofemoral deep vein thrombosis (DVT).

THE OBJECTIVE OF THE STUDY WAS TO look at early clot removal using endovascular intervention, which aims to reduce post-thrombotic syndrome (PTS) following iliofemoral DVT. The presenter noted that this technique has the possibility to reduce long-term morbidity, though it incurs a higher cost initially. The study examined the costeffectiveness of pharmacochemical thrombectomy (PMT) and catheter-directed thrombolysis (CDT) in comparison with oral anticoagulation for acute iliofemoral DVT in the United Kingdom.

Pouncey opened her presentation by explaining what cost-effectiveness meant in the study. “Our healthcare resources are finite,” she said. “So, if you spend a load of money on a treatment that doesn’t work, you are essentially going to harm patients and harm the healthcare system.You want to cause a healthgain, and you want this to be at an acceptable cost.”

Patients were measured using a quality-adjusted life year (QALY), which is a measure of how valuable the patient’s life is adjusted for how long they’re living.

“We can then use this to calculate something called an ICER, which is an incremental cost effectiveness ratio,” Pouncey told the audience. DVT “is a really

significant health-economic burden. So, roughly 50% of patients with an iliofemoral DVT will go on to develop [PTS]. This is a chronic, debilitating, and really expensive condition.”

Pouncey then went on to describe how she and her team went about conducting their study.

“The first step when you perform a costeffectiveness analysis, is you need to know what you’re looking at,” she said. “You need to know the patient population that you’re looking at.”

Pouncey and her team used a front-end decision tree to model possible patient outcomes in the acute setting. She explained that, “these are things like death, pulmonary embolism, bleeding from the treatment. Then once a patient, if they survived, got through to the chronic health state, we used something called a Markov model to model transitions between PTS states over time.”

The study defined cost based on the United Kingdom’s National Health Service national tariff workbook.

Aspirex achieves 78% two-year primary patency rate in P-MAX postmarket observational study At the Leipzig Interventional Course (LINC) 2024 (May 28–31, Leipzig, Germany), Michael Lichtenberg (Arnsberg Vascular Clinic, Arnsberg, Germany) shared for the first time a 24-month update from the P-MAX study of the Aspirex (BD) endovascular thrombectomy system in the treatment of acute venous occlusions. The study’s principal investigator highlighted procedural and technical success rates of 97.5% and a 24-month primary patency rate of 77.9% among other key findings.

P

-MAX is a prospective, multicentre, postmarket observational investigation designed to evaluate the outcomes of Aspirex in patients with deep vein thrombosis (DVT) of the pelvis, legs, and the inferior vena cava (IVC).

The study has enrolled patients at nine centres across the European Union, with follow-up already conducted for post-index procedure (discharge) and at one, six and 12 months. At LINC 2024, Lichtenberg shared 24-month follow-up data and noted that 36-month follow-up is also planned.

The presenter noted that patients over the age of 18 with acute thrombotic or thromboembolic occlusion (defined as the onset of pain within 14 days) and who signed a written informed consent form were included in the study. Key exclusion criteria included unsuitability for thrombectomy and known, unhealed, pre-existing mechanical damage to the vessel wall caused by surgical procedures or interventional complications, among other factors.

Lichtenberg shared with the LINC audience that 81 patients were enrolled in the study, consented to treatment, and subsequently treated with Aspirex. The mean age of these patients, he added, was 49.3±17.4 years, with 50.6% and 49.4% of the patients being male and female, respectively.

Regarding follow-up, Lichtenberg detailed that 80 (98.8%) patients completed one-month follow-up, reducing to 78 (96.3%) at six months, 74

“We added up the cost of acute intervention, and if you look at oral coagulation, it’s considerably cheaper than CDT and PMT. That is because of the cost of stenting, equipment, and increased hospital stay,” Pouncey stated.

However, after performing a base case analysis, the results were interesting.

“What we actually found is that both CDT and PMT were dominant over oral coagulation. What that means, is that they were both more effective and, over the lifetime, less costly,” Pouncey explained.

“In conclusion, CDT and PMT may be cost effective over [oral anticoagulation],” Pouncey told the audience. “This is because of a reduction in the long-term costs of moderate and severe PTS, will offset the early treatment costs. However, there is still significant uncertainty, and we need to continually update our analysis.”

“If you spend a load of money on a treatment that doesn’t work, you are essentially going to harm patients and harm the healthcare system. You want to cause a health-gain, and you want this to be at an acceptable cost”

(91.4%) at 12 months, and 66 (81.5%) at 24 months.

Lichtenberg provided some details on the medical history of the patients enrolled in the trial, noting that 21/81 (25.9%) were smokers, 5/81 (6.2%) had diabetes mellitus, 29/81 (35.8%) had hypertension, 11/81 (13.6%) were on systemic contraceptives, and 3/81 (3.7%) were undergoing cortisone therapy.

The presenter also detailed the key lesion characteristics of the 81 patients enrolled in the study. The mean target lesion length was 204.9mm, with a majority (70.4%) of the vessels occluded being veins, and the most common thrombus location being the external iliac vein (74.1%).

Procedural success in the P-MAX study was defined as intervention with Aspirex, with or without adjunctive treatment, being sufficient to remove the thrombus; maintain restored blood flow at least 72 hours post-intervention; avoid critical injuries at access site, route of

“Mechanical thrombectomy for iliofemoral DVT is safe and effective”

Michael Lichtenberg

catheter and target site; and be absent of acute distal embolism respective of pulmonary embolism. This was achieved in 79/81 (97.5%) patients.

Technical success was defined as a successful thrombectomy, which was

ANNA POUNCEY

achieved in 79/81 (97.5%) patients.

Primary patency was defined as freedom from reintervention, which was achieved in 79/80 (98.8%) patients at discharge, 75/80 (93.8%) at one month, 70/79 (88.6%) at six months, 62/72 (82.7%) at 12 months, and 53/68 (77.9%) at 24 months.

Safety was defined as serious adverse events (SAE) rate, procedure-related adverse events (AE) rate, and serious adverse device events (SADE) rate at one, six, 12 and 24 months.

Lichtenberg relayed that the SAE rate results were 27/81 (33.3%), 34/81 (42%), 40/80 (50%), and 46/77 (59.7%) at one, six, 12 and 24 months, respectively. The corresponding figures for AE rate were 11/80 (13.8%), 11/79 (13.9%), 11/74 (14.9%), and 11/66 (16.7%) and for SADE rate were 2/80 (2.5%), 2/79 (2.5%), 2.74 (2.7%), and 2/64 (3.1%).

In terms of secondary endpoints, the presenter reported that Venous Clinical Severity Score (VCSS), Venous Disability Score (VDS) and ClinicalEtiology-Anatomic-Pathophysiologic Score (CEAP) all improved from baseline—an improvement that he shared was sustained out to 24-month follow-up.

Speaking to Venous News following his presentation at LINC 2024, Lichtenberg commented: “Based on the very positive data from this study as well as others for mechanical thrombectomy, I suggest we stop thrombolysis therapy. Mechanical thrombectomy for iliofemoral DVT is safe and effective.”

Issue 18 / June 2024

Market Watch

Clinical News

Product News

Catheter-directed mechanical thrombectomy system demonstrates safety and effectiveness in patients with PE

New data from APEX-AV demonstrated that catheter-directed mechanical thrombectomy is safe and effective in patients with acute intermediate-risk pulmonary embolism (PE) with significant improvement in the right ventricle (RV) function and minimal major adverse events. The safety and efficacy results from the prospective trial were presented today as late-breaking science at the Society for Cardiovascular Angiography & Interventions (SCAI) 2024 Scientific Sessions (May 2–4, Long Beach, USA).

APEX-AV is a prospective, singlearm, multicenter investigational device exemption trial in which patients with acute intermediate-risk PE were treated with the AlphaVac F1885 aspiration system. The primary efficacy endpoint was a change in the right ventricleto-left ventricle (RV/LV) ratio from baseline to 48 hours post-procedure on core lab–adjudicated computed tomography angiography. The primary safety endpoint was a composite of 48 hours post-procedure major adverse

AlphaVac system

events: device-related death, major bleeding, and device-related serious adverse events.

Among the 122 patients treated at 25 US sites, the average reduction in the RV/LV ratio was 0.45 with a 35.5% mean percentage reduction in the overall clot burden from the baseline at 48 hours post-procedure. Five patients had major adverse events within the 48hour visit and no death was reported.

Lastly, procedural times were short with a mean procedural time of 37.2 ± 17.7 minutes.

“Pulmonary emboli can be extremely dangerous and require effective and prompt action,” said William Brent Keeling, Associate

Professor at the Emory School of Medicine in Atlanta, USA, and lead author of the study.

Johnson Company group chairman of cardiovascular and specialty solutions and vision.

Novel thrombectomy system demonstrates positive safety and feasibility results in treating acute PE

VVT Medical receives approval from Korean Ministry of Food and Drug Safety for ScleroSafe

Late-breaking data from the ENGULF trial showed that a novel dual-action thrombectomy device was effective and safe in treating acute pulmonary embolism (PE). The safety and effectiveness results were presented today as late-breaking science at the Society for Cardiovascular Angiography & Interventions (SCAI) 2024 Scientific Sessions (May 2–4, Long Beach, USA) and simultaneously published in JSCAI. PE can be life-threatening, with up to 30% of individuals dying within one month of diagnosis. Despite recent advances in therapeutic options, PE still carries a high risk of mortality and morbidity with few US Food & Drug Administration (FDA) -cleared thrombectomy catheters available to physicians.

The ENGULF trial is a prospective, single-arm, first-in-human, safety and feasibility study evaluating a novel embolectomy catheter system for the treatment of acute PE with a steerable and expandable funnel and an internal agitator, the Hēlo PE thrombectomy system.

Patients underwent a pre- and 48-hour post-procedural computed tomography (CT) scan. The primary efficacy outcome was the percent difference in the pre-to-post procedural right ventricle–to–left ventricle (RV/ LV) ratios. The primary and secondary safety outcomes were all-cause mortality, major life-threatening bleeding, device-related serious adverse events, pulmonary or cardiac injury, and clinical decompensation at 48 hours and 30 days post-procedure.

All 25 patients from eight centers underwent successful embolectomy.

The mean RV/LV ratio was 1.53±0.27 at baseline and 1.15±0.18 at 48 hours post-procedure (23.2%±12.81% change). Of note, there were no major adverse events at 48 hours and no deaths at 30 days.

Ice aspiration system

Expanse Ice aspiration system receives US FDA clearance for vessels of the peripheral arterial and venous systems

Expanse Ice recently announced that its Ice aspiration system has received 510(k) clearance from the US Food and Drug Administration (FDA). A press release notes that the Ice system is specifically designed to address the complex challenges associated with peripheral thrombectomies.

Eitan Konstantino, an entrepreneur in the vascular device field, is the driving force behind Expanse Ice. “We’ve engineered the Ice catheter system to harness the aspiration power typical of a large bore catheter, but within the slender profile of a much smaller device,” Konstantino said.

“It is clear this device was built with physicians in mind. It aims to address some of the biggest issues we see regularly. The device was designed and built with a strong understanding of foundational physics that leaves me optimistic for its success,” said Michael Lichtenberg, chief medical officer of angiology at the Vascular Center Clinic in Arnsberg, Germany.

“I am looking forward to being among the first users of the Expanse Ice system. Its ability to offer powerful clot removal in a compact size is an intriguing proposition that could significantly enhance our ability to meet patient needs more effectively and improve treatment outcomes in peripheral vascular disease,” said Aravinda Nanjundappa, director of peripheral vascular interventions at the Cleveland Clinic in Cleveland, USA. “The thrombectomy market is witnessing robust growth and the approval of the Ice system comes at an auspicious time,” said Shlomi Nachman, former Johnson &

VVT Medical has announced the completion of good manufacturing processes (GMP) certification and registration of novel non-thermal, anesthesia-free treatment for varicose veins. This milestone approval adds to the recent US Food and Drug Administration (FDA) 510(k) clearance and existing CE mark, reinforcing ScleroSafe‘s position as a trusted solution with regulatory approvals worldwide.

A company press release reads: “The approval of ScleroSafe by the Ministry of Food and Drug Safety (MFDS) marks a significant achievement for VVT Medical in the Korean market.

With the demand for innovative medical solutions on the rise in Korea, ScleroSafe offers a unique, painless, and anesthesia-free treatment option that aligns perfectly with the country’s growing preference for minimally invasive procedures to treat varicose veins.”

“We are delighted to receive approval from the MFDS for ScleroSafe,” said Erez Tetro, CEO of VVT Medical. “This endoresement underscores our commitment to providing cutting-edge technologies that improve patient outcomes and set new standards in vascular treatment.”

VVT Medical aims to strategically collaborate with leading Korean healthcare professional to introduce ScleroSafe and drive advancements in vascular care across Korea. Through these partnerships, VVT Medical seeks to improve access to advanced treatment options and elevate the standard of patient care nationwide.

The launch of ScleroSafe in Korea signifies a significant stride in VVT, reinforcing the company’s position as a pivotal player in the medical device industry. With a focus on addressing the needs of tens of millions of varicose vein patients worldwide, VVT Medical continues to prioritize innovation and excellence in healthcare.

Conference calendar June 13–14 Royal Society of Medicine Venous Forum London, UK

June 27–29 European Venous Forum (EVF) annual meeting 2024 Athens, Greece

June 19–22 Vascular Annual Meeting (VAM) 2024 Chicago, USA

rsm.ac.uk/events/venous/2023-24/ ves01/

vascular.org/vam-2024

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europeanvenousforum.org

Oct. 10–13 American Vein & Lymphatic Society’s 38th annual congress (AVLS 2024) Chicago, USA

Nov. 2–3 The VEINS (Venous Endovascular Interventional Strategies) 2024 Las Vegas, USA

Sept. 14–18 Cardiovascular and Interventional Radiological Society of Europe (CIRSE) annual congress 2024 Lisbon, Portugal

Oct. 17–19 Venous Symposium Europe 2024 Athens, Greece

Nov. 19–23 VEITHsymposium 2024 New York, USA

cirsecongress.cirse.org/about/ theannualcongress/

myavls.org/annual-congress-2024. html

venoussymposiumeurope.com

viva-foundation.org/veinsprogramming

veithsymposium.org/index.php

Feb. 2–5, 2025 International Symposium on Endovascular Therapy (ISET) 2025 Hollywood, USA hmpglobalevents.com/iset

Feb. 16–19, 2025 American Venous Forum 2025 Atlanta, USA venousforum.org/education/ annual-meeting

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