Venous News 17 – February 2024

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FEBRUARY 2024 / Issue 17

Featured in this issue:

3 Approaching combined disease Mona Gupta

6 IVUS

8 Profile

Proceedings from a multispecialty peripheral roundtable published

Manj Gohel

Forecasting their Charing Cross (CX) 2024 venous program highlights, executive board members Stephen Black (London, UK), Manj Gohel (Cambridge and London, UK) and Erin Murphy (Charlotte, USA) discuss the “exciting” controversies and debates, first data releases and a “much expanded” workshop program bringing cutting-edge technology straight from the podium into practice.

By Jocelyn Hudson

First dedicated IVC stent assessed in multicenter study

The Gore VIAFORT vascular stent inferior vena cava (IVC) study, which is being led by co-principal investigators Stephen Black (London, UK) and Kush Desai (Chicago, USA), is set to provide some much-needed data on the treatment for iliocaval obstruction.

Black, consultant vascular surgeon at Guy’s and St Thomas’ Hospital and professor of venous surgery at King’s College London, notes that the study is introducing the first dedicated IVC stent, which, he comments, “will give us something different for these patients and hopefully improve the outcomes in this difficult group”.

Desai, associate professor of radiology, surgery and medicine and director of deep venous interventions in the Division of Interventional Radiology at Northwestern University Feinberg School of Medicine, goes into detail about the rationale for conducting the study. “There are now several investigational device exemption [IDE] trials for iliofemoral disease, where we have devices provided by numerous

companies that have been investigated in similar—but not identical—fashions for iliofemoral venous obstruction,” he says. There is a “gaping hole” in the evidence base when it comes to iliocaval disease, however, which, Desai notes, is particularly noticeable in relation to on-label and purpose-built treatments for IVC obstruction.

This gap in the literature is made starker by the fact that management of IVC obstruction is typically more complex than that of iliofemoral obstruction. Desai notes that a large part of his and his colleagues’ practice is the treatment of IVC obstruction, and that these patients are “significantly more challenging from multiple perspectives, not only technically, but with regard to long-term management and ensuring the best options for patency”.

“There really was a compelling need for an iliocaval obstruction device,” he tells Venous News. This need, he notes, was recognised by Gore, which proceeded to build a device designed specifically for this anatomy.

The current landscape of care for iliocaval obstruction is, according to

Results of a US study highlight racial and ethnic disparities in placement

CX 2024 program seeks to challenge venous controversy “head on” to build practice of the future

In the making: Data-driven venous care

The quest for more data—specifically multicenter, independently adjudicated and, where possible, randomized—in the field of venous disease continues, with various trials currently underway set to provide some eagerly anticipated evidence. The path to best practice is long and winding, however. Many obstacles, among them variations in treatment approach, the difficulties of randomizing patients, and the lasting effects of a global pandemic, must all be overcome.

14 I VC filters

“In addition to the lack of multicenter data for the treatment of iliocaval obstruction, you have such a variety of approaches, which hinders progress.”

KUSH DESAI Desai, “a bit all over the place”. He explains that treatment is currently all off-label in this space. Some physicians use legacy stents like the Wallstent (Boston Scientific), he explains, while others—including Desai and Black— perform double-barrelled reconstructions with off-label iliofemoral stent designs.

“In addition to the lack of multicenter data for the treatment of iliocaval obstruction, you have such a variety of approaches, which hinders progress,” Desai summarizes.

Desai reports that the VIAFORT study is now “well under way,” with the hope being that the trial will be fully enrolled

“THE THEME OF THIS YEAR is controversies, and it is just as well because there seems to be a neverending supply of controversial and debated areas in the venous space,” Gohel details. He explains that a key area housed in controversy will be appropriate care, as, with the “explosion of technologies” today he believes there has been a “real tendency to overtreat some pathologies”, which the co-chairs seek to address.

On this topic, he expands that international speakers will gather to discuss the broad variations of venous disease to “help the CX audience understand what the solid indications and foundations are for treating these pathologies”, he continues.

Adding to this, Black brings awareness to the realization that deep venous disease treatment has “expanded”, which has raised the “issue” of appropriateness, agreeing with Gohel. The CX 2024 program, he asserts, will address how treating a group of patients that are “much younger than their arterial contemporaries that we are normally familiar with” will expand on the “controversy” surrounding how a stent can remain patent for 40–50 Continued Continued on on page page 24

Continued on page 2

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February 2024 / Issue 17

Cover Story

In the making: Data-driven venous care Continued from page 1

by the end of the year.

Despite the good progress being made, Desai shares that the investigators continue to face a series of challenges. One of these relates back to Desai’s point about there being such a variety of approaches to treating IVC disease. “We’re finding that people have just so many different ways of doing it and, in order to have a trial that is scientifically rigorous and also, frankly, useful in terms of what it tells us about the disease state and how to move forward, you have to have some sort of coherence in approach, and that’s probably one of the bigger challenges from this trial,” he says.

Looking ahead, Desai underscores two main hopes for the VIAFORT study. One is that venous practitioners will have a proven, purpose-built system for iliocaval obstruction management. The second and “probably one of the more exciting things about this trial” is that it will be the first multicenter, independently adjudicated trial to look at iliocaval obstruction management in a space where the literature includes mainly single-center, retrospective studies.

Desai is keen to see more multicenter efforts with independent adjudication going forward. “The reported literature for outcomes in venous disease mainly come from single-center attempts, and once you subject a therapy to scrutiny—through not only a multicenter approach but independent adjudication of data— the truth can be quite different,” he says.

PTS patients soon to have randomized data backing care

Another dataset in the making is due to provide randomized evidence for patients suffering from postthrombotic syndrome (PTS). Suresh Vedantham (St Louis, USA) is principal investigator of the C-TRACT trial—a multicenter RCT evaluating

if the use of iliac vein stent placement along with standard PTS care is superior to standard PTS care alone in improving PTS severity and quality of life. The study is sponsored by the National Heart Lung and Blood Institute (NHLBI) of the National Institutes of Health (NIH).

Vedantham, professor of radiology and surgery at Washington University School of Medicine, states that it is not currently known if the clinical change observed in single-arm venous stent studies of patients with PTS is due to

“Medical and endovascular therapies are very different, so some patients have a strong preference towards one or the other, and are unwilling to be randomized.”

SURESH VEDANTHAM stent placement, or other factors.

Remarking more broadly on the landscape of care for the group of patients this trial aims to help, Vedantham shares that, “sadly, most patients with PTS suffer without being diagnosed”. He continues that, for the minority of patients that are diagnosed, PTS care is heterogeneous—a reflection of the absence of evidence-based therapies that show a consistent ability to help patients. Beyond providing data on venous stent placement, Vedantham says, the ambition for C-TRACT is “to help raise awareness of PTS and

increase the number of patients who receive dedicated attention to it”.

While enrollment in the trial is well underway, Vedantham points out that randomization has proved difficult.

By way of context, he stresses that it is notoriously difficult to randomize patients into endovascular therapy trials across disease states, with C-TRACT being no exception.

“Medical and endovascular therapies are very different, so some patients have a strong preference towards one or the other, and are unwilling to be randomized,” he says. In addition, Vedantham notes that medical physicians are less knowledgeable about endovascular therapies, while proceduralists can be “exceedingly ‘pro-intervention’”.

Furthermore, he details that very few physicians receive dedicated training in recruitment science and best practices. As a result, Vedantham explains, “it takes a major studyspecific effort to train investigators on properly communicating clinical equipoise to a potential participant”.

The wide availability of and reimbursement for some procedures compounds the aforementioned problems, Vedantham adds.

Finally, he points out that asking an endovascular provider to refer a patient to another endovascular provider who is located at a study site “flies against current culture”. Vedantham concludes on a positive note, however, opining that “there are many opportunities for collective improvement in terms of shifting the culture, incorporating technology, and prioritizing the most rigorous studies”.

Randomization has not been the only challenge. “[COVID-19’s] onset came right after a critical investigator meeting, when C-TRACT was about to take off,” Vedantham recalls. “Due mainly to coordinator turnover issues, C-TRACT closed more than a third of its study sites,” he details.

The investigators have had to make changes, with many follow-up visits now conducted remotely. There is an upside to this, however, which is that the adaptations “appear to have largely succeeded in enabling us to maintain data completeness”.

“Going forward, I hope it will be relatively smooth sailing.”

Editors-in-chief: Stephen Black, Manj Gohel and Erin Murphy | Publisher: Stephen Greenhalgh Content Director: Urmila Kerslake | Head of Global News: Sean Langer Editor: Jocelyn Hudson Jocelyn@bibamedical.com | Editorial contribution: Bryan Kay and Éva Malpass Design: Terry Hawes and Wes Mitchell Advertising: Jamia Trigiani jamia@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 PERCEPTIONS OF VENOUS DISEASE: In October of last year, Venous News reported on the results of a survey suggesting that venous work is less valued than arterial interventions. In this issue of the newspaper, Sarah Wells (Montreal, Canada), Eric Pillado (Chicago, USA) and Laura Marie Drudi (Montreal) dissect the reasons behind this and argue that a shift in the perception of venous disease is “necessary”.

For more on this story go to page 5 n COMPUTER-ASSISTED VACUUM THROMBECTOMY: Patients undergoing computer-assisted vacuum thrombectomy with the Indigo aspiration system (Penumbra) Ido Weinberg for pulmonary embolism (PE) showed 2.7% rates of both major adverse events (MAEs) and major bleeding at 48 hours post-procedure alongside “a significant reduction” in right ventricle/ left ventricle (RV/LV) ratio of 25.7%, according to an interim analysis of the STRIKE-PE study.

For more on this story go to page 10 n LESSONS ON LEADERSHIP: “Expect—and prepare for—the unexpected,” Karen Gibson, Sergeant at Arms at the United States Senate, told the UIP 2023 World Congress (Sept.

17–21) during a keynote address entitled ‘Leadership in crisis’. Speaking with Venous News, Gibson summarizes some key messages from her talk at the Miami, USA, meeting and shares advice on how to be a good leader in a high-pressure working environment, extolling in particular the benefits of continuous learning.

For more on this story go to page 13

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Issue 17 / February 2024

Comment

POINT OF VIEW

Approaching combined disease: Treat superficial, deep or both?

MONA GUPTA

Mona Gupta (Chicago, USA) writes about the importance of acknowledging the “complex relationship” between the deep and superficial venous systems.

T

he complex relationship between the deep and superficial venous systems is an important one to recognize and understand in order to fully treat patients. In the absence of an established treatment algorithm, the clinician must diagnose the coexisting abnormalities and determine which system to treat. Beyond that, the clinician must decide the order in which to treat, and whether both systems actually require treatment to achieve adequate symptom control.

Previously, treatment of chronic venous disease was limited to managing superficial venous reflux caused

by incompetent valves. Now, we have a better understanding that the pathophysiology is multifactorial and includes calf muscle pump function, decreased venous compliance, axial deep reflux, and venous outflow obstruction.

Chronic obstruction in the deep venous system commonly results from post-thrombotic inflammation and residual thrombosis or by external compression of the iliac veins.

Multiple studies have proven that treating the outflow obstruction does not worsen the distal reflux.1 Similarly, we have data supporting the treatment

of the superficial venous system in the setting of deep reflux and chronic deep vein thrombosis (DVT).2 With this information, we can confidently treat the superficial or the deep or both.

In my clinical setting, that of an outpatient vein clinic specializing in superficial venous reflux, deep venous disease walks in the door daily. Sometimes it is straightforward: the patient with a history of left leg swelling or left leg DVT and absence of superficial venous reflux on standing duplex ultrasound. Or the patient with the recurrent venous leg ulcer (VLU) who has had the superficial system closed.

But most often, it is a more complex diagnosis. The most important risk factors that I have been able to identify in my practice that make me suspect deep venous obstruction are prolonged common femoral vein reflux, out of proportion to the superficial reflux identified; history of DVT and/or inferior vena cava (IVC) filter; recurrent venous ulcer despite adequate treatment of the superficial system and thorough wound care; and recurrent superficial venous disease.

In patients in whom I suspect concomitant deep venous disease, I order a computed tomography (CT) venogram of the abdomen and pelvis to evaluate. I then assess the patient’s standing duplex ultrasound and the CT findings, combined with the patient’s symptoms. My general rule is to treat the dominant symptom first.

In patients with edema below the knee or new presentation of a venous ulcer, I am likely to close the superficial system

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first and monitor the patient’s recovery.

In patients with thigh edema, venous claudication, or recurrent/recalcitrant venous ulcers, I am more likely to treat the deep venous system first knowing these patients will likely require a superficial ablation as well.

Suspecting deep venous obstruction in the setting of superficial venous reflux is the first step. The next step is correctly diagnosing the coexisting disease patterns, determining how and when to treat, while prioritizing the patient’s primary symptoms.

Mona Gupta is associate professor of radiology at Northwestern University Feinberg School of Medicine in Chicago, USA. References: 1. Neglén P, Thrasher TL, Raju S. Venous outflow obstruction: an underestimated contributor to chronic venous disease. J Vasc Surg. 2003;38:879– 885.

2. Benfor B, Peden EK. A systematic review of management of superficial venous reflux in the setting of deep venous obstruction. Journal of vascular surgery: Venous and Lymphatic Disorders.

2022;10(4):945–954.

“In the absence of an established treatment algorithm, the clinician must diagnose the coexisting abnormalities and determine which system to treat.”

Abramowitz et al plumbed ATTRACT, the largest trial mechanical thrombectomy versus anticoagulation (3.3 Mechanical in the venous space to assess pharmacomechanical vs. 6.3 at 30 days; 2.5 vs. 5.5 at six months; and 2.6 vs. catheter-directed thrombolysis (pCDT) compared 4.9 at 12 months; p <0.001). thrombectomy to anticoagulation, and the single-arm CLOUT “Propensity score matching of patients in the registry, which included patients receiving mechanical ATTRACT and CLOUT studies showed that, demonstrates thrombectomy with the ClotTriever. despite more limited use of compression stockings, A total of 164 pairs were matched, with no treatment with mechanical thrombectomy resulted superior outcomes significant differences in baseline characteristics after in a significantly lower PTS incidence and improved matching, the authors noted.

Villalta scores compared with anticoagulation to anticoagulation in anyThey found that there were fewer patients with treatment,” the authors wrote. “Those treated with PTS at six months (19% vs. 46%; p<0.001) and mechanical thrombectomy had 27% and 21% lower DVT patients, analysis 12receiving months (17% vs. 38%; p< 0.001) among patients rates of PTS at six and 12 months, respectively, as well mechanical thrombectomy. as significantly lower mean Villalta scores at 30 days, of RCT and registry Abramowitz and colleagues discovered upon six months, and 12 months. Similarly, matched patients statistical modeling that, after adjusting for baseline treated with anticoagulation were found to have 3.1 data shows Villalta scores, patients treated with anticoagulation times the odds of developing PTS at 12 months in had “significantly higher odds” of developing any PTS logistic regression modeling adjusting for baseline

Mechanical thrombectomy using the ClotTriever device (Inari Medical) for iliofemoral deep vein thrombosis (DVT) was found to be “associated with significantly” lower Villalta scores and a lower incidence of postthrombotic syndrome (PTS) out to 12 months compared with treatment using anticoagulation, a propensity score matching analysis of a large randomized controlled trial (RCT) and registry data showed.

THE STUDY FINDINGS, LED BY FIRST author Steven Abramowitz, associate professor of surgery at Georgetown University School of Medicine and chair of the Department of Vascular Surgery at MedStar Washington Hospital Center in Washington, DC, USA, were published online in the Journal of Vascular Surgery-Venous and Lymphatic Disorders (JVS-VL).

To assemble a propensity matched cohort,

(odds ratio [OR] 3.1; 95% confidence interval [CI], 1.5–6.2; p=0.002), or moderate-to-severe PTS (OR 3.1; 95% CI, 1.1–8.4; p=0.027) at 12 months compared with those treated with mechanical thrombectomy.

They further found that mean Villalta scores were lower through 12 months among those receiving

“Matched patients treated with anticoagulation were found to have 3.1 times the odds of developing PTS at 12 months.”

STEVEN ABRAMOWITZ ET AL

Villalta scores.”

The authors noted the inherent limitations of propensity score matched analyses like the one they conducted. “A comparison of different clinical studies using propensity score matching by its nature introduces the possibility of bias from factors that differ between studies that are either unknown or unable to be controlled for,” Abramowitz et al wrote.

They highlighted how a RCT comparing iliofemoral DVT treatment using contemporary mechanical thrombectomy or anticoagulation would address most of their study’s limitations.

“Results from currently enrolling clinical trials will further clarify the role of these therapies in the prevention of Steven PTS following an acute DVT Abramowitz event,” the authors concluded.

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February 2024 / Issue 17

CX 2024

CX 2024 program seeks to challenge venous controversy “head on” to build practice of the future Continued from page 1

years, delivering clinical benefit to the patient throughout that period.

“We are looking at concepts of stent maintenance, of in-stent restenosis, how to keep stents open, how to better select patients, how to deal with in-flow—all the adjunctive techniques that we start to need to make a difference to patients today. That is what I am really enthused about and hope we can start stirring some discussion about,” says Black.

For Murphy, the “willingness” of the selected CX faculty to engage in discussion about these current challenges “head on” is what sets the symposium apart and will be reflected in the debates that are set to take place in 2024. “CX has been amazing for so many reasons—the debates are one of

my favorite areas,” she notes.

CX 2024 will also continue to be a space for first data releases; Murphy draws attention to new data which will be emerging from areas such as venous valve creation and pulmonary embolism, including a trial for pelvic venous congestion—a “controversial” area lacking data to date on which “exciting” recent work will be presented at the ExCeL center in London, UK. On the topic of data releases, Gohel expects that the superficial venous program will expand on the role of non-thermal modalities, particularly cyanoacrylate glue, via the VenaSeal spectrum study. Murphy notes that this is one of the largest randomized trials in the superficial space, concluding with Gohel who states that the release of this data at CX 2024 will provide a

Stephen Black

Manj Gohel

“solid foundation that is needed to build practice going forward”.

According to Black, clot management will also pull focus in the venous program, due to the growing range of devices that are available today.

Considering thrombotic devices, he notes that there has been a “big move away” from lytic toward mechanical thrombectomy only, noting that this is only partially driven by data. “There is absolutely good evidence out there from companies who have committed to randomized controlled trials”, he comments.

Aiming to push boundaries and interrogate best practice, another key focus at CX 2024 will be lively debate. Gohel hints at discussions which will compare whether or not there is adequate evidence to support

Erin Murphy

Large administrative databases enter crosshairs as comparative analysis shows percutaneous mechanical thrombectomy as superior to CDT for acute PE The pitfalls of large administrative databases came to the fore during the presentation of a propensity-match scoring analysis demonstrating that percutaneous mechanical thrombectomy (MT) was superior to catheterdirected thrombolysis (CDT) in patients diagnosed with acute pulmonary embolism (PE). Junji Taukagoshi, a vascular surgery resident at the University of Texas Medical Branch (UTMB) in Galveston, USA, presented the results from the retrospective analysis of patients drawn from the multi-institutional TriNetX network during the 2024 Southern Association for Vascular Surgery (SAVS) annual meeting (Jan. 24–27) in Scottsdale, USA. TAUKAGOSHI AND COLLEAGUES— including senior author Mitchell Cox, the vascular surgery program director at UTMB—showed that MT was associated with fewer 30-day perioperative complications, improved long-term pulmonary hypertension and right heart failure, and significantly fewer emergency room (ER) visits.

They performed the 1:1 propensity-match analysis with around 1,100 in each group who underwent the respective interventions within three days of a PE diagnosis from January 2017 to August 2023.

But the question of whether large administrative databases like TriNetX to produce the granularity of data can enable robust enough analysis quickly emerged when the study came under post-presentation scrutiny, with one questioner suggesting the research team perform sensitivity analysis to “potentially tease out these patients a little bit more precisely to make sure you don’t have a melting pot of individuals.”

Taukagoshi and Cox both acknowledged this limitation, with the latter describing both its benefits— large size, breadth and ease of use—along with the chief drawback that means “you can only get certain data from it.”

Taukagoshi detailed 30-day results show comparable mortality and number of blood transfusions.

“However, MT was clearly superior when it comes to gastrointestinal bleed and intracranial hemorrhage. it is interesting that it was also superior with both lower

rates of myocardial infarction and immediate postprocedural pulmonary hypertension. So, it looks like MT is the clear winner in the acute phase.”

Long term, MT continued to have better outcomes out to five years, Taukagoshi continued. “While mortality is not that much different, the incidence of chronic pulmonary hypertension and right heart failure are much improved in patients who had MT. They also had significantly fewer ER visits.”

Commenting further, he said 30-day data clearly showed MT as associated with “significantly fewer bleeding complications compared to CDT, which can be explained by thrombolytics,” alongside the lower incidence of MI and immediate postoperative pulmonary hypertension.

“Why is that?” he asked.

“We would speculate that more rapid clot

“We would speculate that more rapid clot clearance with MT might result in less myocardial strain and more rapid improvement in pulmonary hemodynamics.”

intervention of non-thrombotic iliac vein lesions as an “exciting” area on the program.

“This has really been an area where we have seen the greatest explosion of interventions around the world, particularly in the USA, and I think we sometimes need to just make sure the evidence supports the aggression and the strength of intervention. So, we are going to plan some really lively, interesting debates for that one and looking forward to that for sure”.

Appraising the location of CX 2024, Gohel reflects that the ExCeL will provide a “much expanded and exciting workshop program” for venous, including expert case presentations and interactions, and will enable the audience to supplement what they see on the podium and try out novel devices.

Wrapping up, Murphy reflects on the legacy left by recently passed Professor Roger M Greenhalgh, internationally renowned vascular surgeon and founder of the Charing Cross series of international symposia—“he was a legend and an inspiration and I hope we can make him proud this year. I believe that the program we are coming up with will do that, and I hope people will join us at CX 2024”.

clearance with MT might result in less myocardial strain and more rapid improvement in pulmonary hemodynamics.”

At five years, MT was also shown to be better, Taukagoshi added. “However, the overall incidence of chronic pulmonary hypertension is certainly higher than in previous studies. Clearly, our patient cohort had a high percentage of very significant high-risk PE events.”

So, is MT truly better? Taukagoshi asked, as he pointed to the limitations inherent in large databases.

He further revealed that such data had persuaded his institution to shift away from thrombolysis toward MT in the majority of cases where interventions are required for massive or submassive PE. “In the future, we would like to see if these results can be replicated with other large multi-institutional series or large datasets.”

Discussion points to lack of PE risk stratification information

Designated discussant Jean Panneton, a professor of surgery at Eastern Virginia Medical School in Norfolk, USA, led queries of the paper. He pointed to a lack of PE risk stratification information. “How do you believe that this may have impacted your results— [with] a propensity match that only matched for regular comorbidities, but nothing specific to the actual PE?” In light of the administrative database source of the data and attendant Current Procedural Terminology (CPT) codes, Panneton questioned whether it was possible to know whether all of the interventions for suction thrombectomy or CDT were indeed “actually done for PE.” “Could they have been possibly done for ischemic legs or for the 43% of patients with acute deep vein thrombosis [DVT] in that database?”

Jason Chin, a vascular surgeon at MedStar Health in Baltimore, USA, pointed out the different CDT regimens available and how that might have impacted results.

“It doesn’t seem like this database can parse that out,” he said. “I’m not sure if there is a code for ultrasound-assisted thrombolysis versus no-ultrasound assisted thrombolysis.”

Issue 17 / February 2024

Comment

POINT OF VIEW

Less vain and more vein: Evaluating the perceptions of venous disease amongst the vascular surgery community Sarah Wells, Eric Pillado, Laura Marie Drudi In October of last year, Venous News reported on the results of a survey suggesting that venous work is less valued than arterial interventions. Here, Sarah Wells (Montreal, Canada), Eric Pillado (Chicago, USA) and Laura Marie Drudi (Montreal) dissect the reasons behind this and argue that a shift in the perception of venous disease is “necessary”.

O

ur biases permeate the fabric of our very being, as they weave their way into our training and practice. It is clear that complex aortic work is definitely in vogue and ‘in’, and, well… treating veins gets a bad rap. While training, our staff perpetually complained about not only treating venous disease but also about not having the patience to sit and listen to these ‘complex’ patients. Current vascular surgery training paradigms focus significantly on arterial disease, and training programs rarely focus on venous disease management as part of the core curriculum.

It comes as no surprise that if those teaching the next generation of vascular specialists are not enthusiastic or motivated and possibly even deterring the pursuit of treating venous disease, the next generation will face similar sentiments. It is clear that not all vascular systems are created equal, but why?

The management of venous disease is imperative, as it has been reported to be twice as prevalent as coronary heart disease and five times more prevalent than peripheral arterial disease

(PAD). More than 25 million adults in the USA suffer from chronic venous insufficiency, with more than 6 million having advanced venous disease.2 Further, venous disease cost of care is estimated to range from $3 to $10 billion annually.2,4 However, there seems to be a discrepancy in its perceived importance among vascular surgery specialists.

It has been proposed that there exists a lack of adequate, specific and practical training throughout the academic curriculum presented to future vascular surgeons, which has led to the view that venous pathology, compared to arterial conditions, is of secondary nature.

In addition to this, themes such as less technical challenge, lower morbidity/mortality risk, ease of lifestyle, less institutional support for research or clinical programs, and fewer funding opportunities were highlighted as reasons for the existence of this perception in a survey on the topic Furthermore, the terms “ego” and “prestige” were mentioned when describing rationales for arterial work being more important than those in the field of venous disease.1

New data abound during CX 2024’s venous program This year’s Charing Cross (CX) International Symposium (April 23–25) in London, UK, is set to host over 30 first-to-podium and late-breaking trial presentations across the course of three days. Four of these will be delivered as part of the venous and lymphatic controversies program on the second day of the meeting.

THE FIRST VENOUS PODIUM-FIRST presentation is due to be shared in the deep venous

Vascular surgeons continue to be the largest provider for venous disease care in both medical and surgical specialties.3 More than 17% of all medical and surgical venous care providers do not have active board certification.

Therefore, it behooves our specialty to uphold best practices in venous disease and continue to better understand the venous disease population. Our versatility in open and endovenous surgical management provides our specialty the skillset to care for venous disease when compared to other specialties.

Another important and complex layer involved in this perception of venous and arterial work differing in value is gender bias and disparity. There is a significant lack of literature in venous disease compared to arterial disease regarding healthcare disparities.

Racial/ethnic, gender and socioeconomic disparities impact venous disease similarly to arterial disease, driving how we approach our patients’ care. Chronic venous insufficiency can involve a difficult disease pattern superimposed with various risk factors that vascular surgeons must navigate in a similar way as they do with arterial diseases.

It cannot go unsaid that vascular surgery is a male-dominated specialization and that, interestingly enough, the perception that venous diseases are of less importance stemmed mainly from younger female respondents. It is difficult to determine clearly why this may be the case, but survey data suggest that this disparity in perception paves the way for a key new body of research. An in-depth analysis

“As vascular surgery residents and fellows have reported feeling deficient in venous training, this is logically a root cause in the lack of value it has been historically attributed.”

controversies session, on the morning of Wednesday April 24. Stephen Black (London, UK) will present on ‘Defining the need for a dedicated IVC [inferior vena cava] stent’. Black is a consultant vascular surgeon at Guy’s and St Thomas’ Hospital, professor of venous surgery at King’s College London, and a member of the CX executive board.

Turning the audience’s attention to venous valves, David Dexter (Virginia Beach, USA) will also present a podium first in the deep venous controversies session. Dexter, a vascular surgeon at Sentara Vascular Specialists, will share efficacy results of the SAVVE, or ‘Surgical antireflux venous valve endoprosthesis’, trial. These will be long-term results on the use of a bioprosthetic valve for patients with chronic deep venous reflux.

Wednesday afternoon’s superficial venous controversies session will feature two further podiumfirst presentations. Tobias Hirsch, who is an angiologist

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of existing and potentially inherent gender-based values as drivers for framing systemic perceptions in vascular surgery could be a valuable step in reducing gender bias within the field.

Above all, the scarce exposure of trainees to the array of levels of venous interventions that exist seems to have driven and deeply embedded this perception that venous work is less of a challenge, and, in turn, of less interest to vascular specialists. As vascular surgery residents and fellows have reported feeling deficient in venous training, this is logically a root cause in the lack of value it has been historically attributed.

One could argue it is ironic, as venous disease pathologies are often complex, even more so than arterial ones, yet lack of attention to this nature during training is a recurring theme. A shift in this perception, however, is necessary.

Potential avenues for improving such a deficit could include various mandates with regard to trainee exposure to venous pathologies and interventions, as well as the inclusion of continuing education initiatives, similar to that of advanced aortic training and formal limb salvage. Addressing and reducing the gender bias in existing perceptions may also pave the way for a more equitable view of both venous and arterial work.

Sarah Wells is a clinical research assistant at Centre Hospitalier de l’Université de Montréal (CHUM) in Montreal, Canada; Eric Pillado is an integrated vascular surgery resident at Northwestern Medicine in Chicago, USA; and Laura Marie Drudi is an assistant professor of surgery at CHUM. References: 1. Kiguchi MM, Drudi LM, Jazaeri O, et al. Exploring the perception of venous disease within vascular surgery. JVS: Venous and Lymphatic Disorders.

2023:11(5);1063–69.

2. Kim Y, Png CYM, Sumpio BJ, et al. Defining the human and healthcare costs of chronic venous insufficiency. Seminars in Vascular Surgery. Vol. 34, no. 1, Mar. 2021, pp. 59–64. DOI.org (Crossref), https://doi.org/10.1053/j.semvascsurg.2021.02.007.

3. Gabel J, O’Dell T, Masuda E, et al. Who is treating venous disease in America today? Journal of Vascular Surgery: Venous and Lymphatic Disorders. Vol. 7, no. 4, July 2019, pp. 610–14.

DOI.org (Crossref), https://doi.org/10.1016/j. jvsv.2019.03.009.

4. O’Banion LA, Ozsvath K, Cutler B, et al. A review of the current literature of ethnic, gender and socioeconomic disparities in venous disease.

Journal of Vascular Surgery: Venous and Lymphatic Disorders. Vol. 11, no. 4, July 2023, pp. 682–87.

DOI.org (Crossref), https://doi.org/10.1016/j. jvsv.2023.03.006.

and phlebologist at the Vein Competency Centre Halle (Halle, Germany), will deliver results of the SYNCHRONOUS trial. This trial was designed to evaluate the impact of a synchronous prophylactic treatment of the anterior accessory saphenous vein (AASV) on the recurrent varicose vein rate in patients undergoing thermal ablation of an insufficient great saphenous vein.

The last podium-first presentation of the day will be delivered by Manj Gohel, consultant vascular surgeon at Cambridge University Hospitals NHS Foundation Trust (Cambridge, UK), honorary senior lecturer at Imperial College London (London, UK) and a CX executive board member, and Kathleen Gibson, vascular surgeon and medical director at Lake Washington Vascular (Bellevue, USA). The pair will speak on the VenaSeal Spectrum program of studies, which compare cyanoacrylate glue closure with thermal ablation and surgical stripping.

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February 2024 / Issue 17

Journal Highlights

SCAI, SIR, and SVS jointly publish proceedings from multispecialty peripheral IVUS roundtable Proceedings from an expert consensus roundtable that discussed the benefits of intravascular ultrasound (IVUS) in lower extremity revascularization procedures were released in the Journal of the Society for Cardiovascular Angiography & Interventions (JSCAI), Journal of Vascular and Interventional Radiology (JVIR), and Journal of Vascular Surgery: Vascular Insights.

T

he roundtable focused on the current challenges in diagnosing and treating lower extremity revascularization, knowledge and data gaps, and the potential role of IVUS in addressing these challenges. Experts shared their insights and experiences from the fields of interventional cardiology, interventional radiology, and vascular surgery. The expert consensus meeting was convened by SCAI and co-sponsored by: American Vein and Lymphatic Society (AVLS), American Venous Forum (AVF), Society of Interventional Radiology (SIR), Society for Vascular Medicine (SVM), and Society for Vascular Surgery (SVS).

“Improvements in outcomes following peripheral vascular intervention have lagged compared to other endovascular treatments, such as percutaneous coronary intervention. Both clinical experience and evidence support the greater use of peripheral IVUS to reduce adverse events and extend the patency of our lower extremity revascularization procedures. By gathering experts from different specialties, we aimed to foster collaboration and exchange

ideas to improve patient care for peripheral IVUS,” said Eric A Secemsky (Beth Israel Deaconess Medical Center, Boston, USA), lead author of the proceedings document.

“The roundtable provided a unique opportunity to identify knowledge gaps and discuss how IVUS can enhance our understanding and treatment of peripheral arterial and deep venous pathology.”

Lower extremity revascularization is a critical procedure used to restore blood flow to the legs and feet in patients suffering from peripheral arterial disease (PAD) and deep venous pathology. It is estimated that millions of people worldwide are affected by these conditions, which can lead to severe pain, non-healing wounds, and even limb loss if left untreated.

Although angiography is the dominant imaging modality in revascularization, it has inherent limitations. IVUS is a minimally invasive imaging technique that allows physicians to visualise the inside of blood vessels in real-time. It provides detailed information about the vessel wall, plaque composition, and

Nitinol stents placed in iliac veins “not associated with prolonged back pain,” study finds In a retrospective review of over 600 patients who underwent iliac vein stent placement, the development of back pain was found to be unrelated to stent type, diameter, length or covered vein territory.

CHLOE SNOW (GREENBELT, USA) AND colleagues share this and other findings in a recent Phlebology paper. The review was a joint investigation by researchers at Greenbelt’s Center for Vein Restoration, to which Snow is affiliated, and the Center for Vascular Medicine, also in Greenbelt.

Snow et al write in their introduction that endovascular stenting is the standard of care for the management of symptomatic chronic venous obstruction. However, they note that the increased radial resistive force and longer lengths of nitinol stents often used have “led to questions over persistent postoperative back pain”. The purpose of this investigation, therefore, was to assess the incidence and severity of postoperative back pain associated with nitinol stents compared to Wallstents (Boston Scientific).

The researchers performed a retrospective review of data from the Center for Vascular Medicine, assessing

blood flow characteristics, enabling more accurate diagnosis and treatment planning.

During the roundtable, participants highlighted the potential of IVUS in guiding revascularization procedures, such as angioplasty and stenting, to optimise outcomes for patients. They also emphasized the need for further research and evidence to support the integration of IVUS into routine clinical practice.

“Vascular diseases are complex conditions requiring team-based care, research and information sharing to ensure that patients have access to appropriate, quality care for their condition,” said SIR President Alda L Tam (MD Anderson Cancer Center, Houston, USA). “Ongoing collaboration among these specialties is paramount to improving outcomes for patients worldwide.”

The roundtable concluded with a

patient demographics and preoperative, one-week, three-, six- and 12-month visual analog pain scores (VAS) for back pain, stent type, diameter, length, and vein locations.

In the period April 2014–November 2021, a total of 627 patients—comprising 412 women and 215 men—were assessed for the presence of postoperative back pain after an initial iliac vein stent placement. The authors detail that the stents utilized were Wallstents (n=114), Venovo (BD; n=342) and Abre (Medtronic; n=171). The most common nitinol stent diameter and lengths were 14mm, 16mm and 120mm, respectively, they add, noting a p-value of ≤0.03.

The Venovo venous stent was granted Food and Drug Administration (FDA) premarket approval in 2019. BD reported at the time that theirs was the first stent indicated to treat iliofemoral venous occlusive disease. The previous year, one-year results from the prospective, multicenter, single-arm VERNACULAR

Abre stent Venovo stent

commitment to ongoing interdisciplinary collaboration and knowledge sharing among physicians. Participants agreed that treatment standards, formal training programs and global quality metrics remain needed to improve patient care.

“The roundtable provided a unique opportunity to identify knowledge gaps and discuss how IVUS can enhance our understanding and treatment of peripheral arterial and deep venous pathology.”

ERIC A SECEMSKY

trial had been shared, demonstrating the safety and effectiveness of Venovo for the treatment of symptomatic iliofemoral venous outflow obstruction.

In 2020, Medtronic announced that the Abre venous self-expanding stent system had received FDA approval to treat venous outflow obstruction.

The approval was based on 12-month results from the ABRE clinical study, which assessed the safety and effectiveness of the Abre stent in patients with iliofemoral venous outflow obstruction.

Results

Snow and colleagues report in Phlebology that the incidence of back pain at one week was 66%, occurring in 411 out of the 627 patients assessed in the review.

They add that VAS scores at one week and one, three and six months postoperatively were the following: Wallstents 2.6±3 (n=66), 1.7±2.6 (n=43), 0.7±2 (n=51), and 0±0 (n=27); Abre 3.5±3 (n=130), 3.8±3 (n=19), 1.2±2.5 (n=12), and 1±2 (n=5); and Venovo 2.5±3 (n=216), 2.4±3 (n=70), 0.9±2 (n=68), and 0.6±1.7 (n=49).

The authors state that there was no difference in the severity of back pain at any time point (p≥0.99) and that the development of back pain was unrelated to stent type, diameter, length or covered vein territory.

In their conclusion, Snow et al reiterate that postoperative back pain was observed in 66% of patients at one week, and that the average pain score at one week for the entire cohort was three, which declined to less than one at one month. Furthermore, they found that no difference in the severity of back pain between groups was observed at any time point, and that the development of back pain is unrelated to stent type, diameter, length or covered vein territory.

Issue 17 / February 2024

Advertorial

THIS ADVERTORIAL IS SPONSORED BY OPTIMED

STEVECO trial provides “important evidence” in quest for individualized venous treatment One-year results from the STEVECO randomized controlled trial (RCT) were recently published, providing some much-needed data on the role of venous stenting for patients with chronic venous insufficiency. Here, two of the trial’s investigators speak with Venous News to assess the challenges of conducting a randomized trial in the venous stenting field and the significance of the newly published results.

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 sinusVenous 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 postthrombotic syndrome (PTS) or nonthrombotic iliac vein lesions (NIVLs).

Results of the trial were published in July of last year in the European Journal of Vascular and Endovascular Surgery (EJVES). First author Soroosh Shekarchian (Maastricht, The Netherlands), senior author Houman Jalaie (Aachen, Germany) and colleagues concluded: “Symptomatic patients with deep venous obstruction who received dedicated venous stents had significantly higher VEINES-QoL/ Sym scores at 12 months compared to the control group.”

Jalaie had previously presented the trial design and preliminary data at the Leipzig Interventional Course (LINC) 2022 (June 6–9, Leipzig, Germany) and at VEITHsymposium 2023 (Nov. 14– 18, New York City, USA). “STEVECO demonstrates meaningful quality of life improvement comparing venous stenting to conservative treatment in a randomized trial,” he reported at the time. “This will be important evidence to share with our physician colleagues as we seek individualized treatment for our patients.”

In addition to the quality of life results, the investigators revealed a 91% primary patency and a 97% secondary patency rate with the sinusVenous stent in a challenging patient population. A total of 63 patients were included in the STEVECO trial, with 42 randomized to a stent group and 21 to a control group. Of these patients, the majority had PTS—38 (90.5%) in the stent group and 20 (95.2%) in the control group. From the PTS group, the majority had involvement of the common femoral vein.

Recruitment for STEVECO was a major challenge, as it has been and continues to be for numerous other trials in the venous stenting field.

Shekarchian, Jalaie et al write in their

EJVES paper that after three years, the inclusion rate dropped to almost zero and the trial had to be stopped.

In an accompanying commentary, Stephen Black and Taha Kahn of Guy’s and St Thomas’ NHS Foundation Trust in London, UK, note that, “While the STEVECO trial showed notable improvement in multiple scores of quality of life and disease severity, it failed to reach the prespecified primary endpoint goal” and focus on the difficulties of recruiting for a randomized venous stenting trial.

Black had previously noted that recruiting for a venous RCT is a common problem, stating during a venous session at the 2023 European Vascular Course (March 5–7, Maastricht, The Netherlands) that ATTRACT and CAVA both took 10 years to recruit. “You need to be applauded for trying this,” he said to the STEVECO investigators at the time.

Shekarchian, who is a clinical researcher at Maastricht University Medical Center, comments that recruitment to STEVECO was challenging for various reasons, citing patient reluctance to enter an RCT as one of the most significant. “Many patients knew they could get stenting in other centers, so they refused to be in the control group,” he tells Venous News.

Jalaie, who is head of the European Venous Center Aachen-Maastricht, consultant vascular and endovascular surgeon at the University Hospital RWTH Aachen and principal investigator of STEVECO, also highlights this point. He first notes that chronic venous obstruction patients have likely been suffering from their condition for years and are therefore understandably reluctant to turn down the relatively new and promising treatment option that is venous stenting.

He elaborates with an example of a typical patient he encounters: “Just imagine a patient, a 40-year-old woman, for instance, who has been suffering from chronic venous obstruction from severe PTS for 10 years. Now, she gets the chance to be treated, she’s sent to a high-volume venous center, and someone is asking if she wants to take part in a randomized trial to receive only conservative

treatment.” He notes that this was a common occurrence during the recruitment phase for STEVECO and remains a significant challenge for other prospective randomized venous trials that are currently underway, naming BEST-PTS and C-TRACT as two of the most prominent examples.

Jalaie explains the effect this reluctance amongst long-suffering patients to accept conservative treatment had on recruitment to STEVECO in terms of the numbers.

He points out that from any 10 patients who could have been a candidate for the trial, perhaps four would agree, out of which at least one would be too young or too old, leaving just two or three patients out of those initial 10 to be enrolled.

Jalaie adds that another challenge had to do with encouraging involvement from other centers to ensure this was a truly multicenter trial. He highlights that for a center to be involved in a randomized trial it has to be willing to dedicate a significant amount of time and effort to ensure all tasks, both clinical and non-clinical, are performed thoroughly. “You need images, you need inflow detection, you need to know which kind of patients are being included,” he stresses, adding

Soroosh Shekarchian

Houman Jalaie

“This will be important evidence to share with our physician colleagues as we seek individualized treatment for our patients.”

HOUMAN JALAIE that documentation is a necessary, albeit somewhat time consuming and monotonous part of any properly conducted randomized trial. In addition to these factors, some hospitals are simply not well enough equipped to be able to participate. “You need many things which many hospitals cannot deliver,” he says.

In addition to these challenges, Jalaie points out that the relative newness of venous stenting as a routine treatment option means that it is offered in only a few centers—two or three in the UK, two in Germany and, at that time, only one in The Netherlands. Any patient with chronic venous obstruction sent

to one of the few centers who offer this novel treatment option simply expects to be treated, Jalaie remarks.

Both Shekarchian and Jalaie also comment on the impact of COVID-19.

In March 2020, when the pandemic took hold on a global scale, Jalaie recalls that recruitment for STEVECO had reached around 50 patients. At this time, Jalaie explains that only urgent vascular cases were conducted, with everything else being put on hold.

“Venous cases were not urgent,” Jalaie says, and so, for six or seven months, the STEVECO trial was stopped completely. And once COVID-19 restrictions eased, the restart was slow.

Despite issues with recruitment, both investigators are keen to stress some of the positive ways in which STEVECO has contributed to the evidence base for venous stenting. Shekarchian remarks: “Before STEVECO, the quality of evidence was limited due to the lack of control groups. STEVECO has improved the level of evidence for providing such a treatment.”

He also notes that, while the trial did not reach its prespecified primary endpoint, there were some positive outcomes. “We know that the diseasespecific QoL, pain disease index and VCSS scores were significantly improved after one year of stenting compared with the control group.”

Jalaie recalls that the decision to conduct an interim analysis following the COVID-19-induced hiatus turned out to be a good one. When treatment could resume, the team enrolled another eight or nine patients, and—four years after recruiting the first patient in 2017—decided alongside Optimed to conduct an analysis before they had initially planned to.

“We were excited about it,” Jalaie shares, emphasizing again how “painful” the inclusion process had been. “The interim analysis luckily showed a significant change,” he reports. While recognizing that the primary aim of the trial was not achieved, he stresses the significance of the fact that the interim analysis showed the changes that it did with only 63 out of a planned 100 patients and after only one year. This shows the power of recanalization and stent angioplasty using dedicated venous stents, according to Jalaie.

“If a patient is selected correctly, [venous stenting] helps, and it will 100% increase the level of evidence, even with some shortcomings,” Jalaie says in summary, pointing to the effect the trial will have on propelling other venous stenting trials forward. “Overall, I am very happy because I was afraid the interim analysis wouldn’t show anything, then all the work would have been for nothing. [STEVECO] will add to the level of evidence and probably give more energy to the centers who are participating, as well as for BESTPTS in the UK and for C-TRACT in the USA.”

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February 2024 / Issue 17

Interview PROFILE

MANJ GOHEL

“As I learned more about venous pathologies, it became abundantly clear that patients with venous disease were a largely neglected population in need of strong, passionate advocates,” Manj Gohel (Cambridge and London, UK) tells Venous News, recalling his decision to specialize in the treatment of venous disease. Gohel is now at the forefront of venous care—a consultant vascular and endovascular surgeon at Cambridge University Hospitals NHS Foundation Trust, clinical lead for the Cambridge Vascular Unit and honorary senior lecturer at Imperial College London. He shares in this interview some career highlights so far, as well as his thoughts on the venous space more widely, outlining some key challenges that must be addressed—notably case selection and the ongoing debate regarding appropriate care—while also stressing that the venous field is currently a “vibrant space” for ongoing clinical research.

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

I grew up in Birmingham, UK, and my plan at school was always to study mathematics at university. I only considered medicine after speaking to a doctor at a careers event and his infectious passion and enthusiasm really stood out for me. Despite the enormous challenges of working in healthcare, particularly the UK National Health Service (NHS), I have never regretted my decision. It is an enormous privilege to work in healthcare and to be trusted by patients and families during their most difficult times.

During my junior surgical training, I thoroughly enjoyed all the different specialities I worked in. However, I was particularly fascinated by vascular surgery, as blood vessels had been a source of great fear and anxiety previously. Much of my vascular training occurred during the endovascular revolution, adding an exciting new dimension of therapies to traditional open surgery. Vascular surgery offers technically challenging surgeries and dramatic acute clinical presentations, but is also enormously unforgiving and undoubtedly tests your resilience. My interest in venous disease stems from my involvement in the ESCHAR trial, early in my surgical career. As I learned more about venous pathologies, it became abundantly clear that patients with venous disease were a largely neglected population in need of strong, passionate advocates.

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

I have been enormously fortunate to have worked with some inspirational trainers and mentors, many of whom are now close friends.

As an eager, but unfocused junior surgeon, I worked with Keith Poskitt, a vascular surgeon in Cheltenham (a district hospital in the UK).

He had set up an outstanding, nurse-led leg ulcer service in the region, and despite limited resources, he had inspired the ESCHAR study.

Keith was inspirational for his single-minded passion, always putting the patient first. I was able to join the research team and have been heavily involved in venous/leg ulcer research ever since.

After moving to London to continue my training, I worked with Alun Davies and we continue to work closely on several research projects. I have learned many things from Alun, not least the importance of collaboration and the power of being inclusive. The EVRA study is a tremendous example of how a strong

collaboration between passionate researchers can result in successful and impactful clinical research.

Since completing vascular surgery training, I have worked in Cambridge University Hospitals with outstanding and supportive colleagues and been fortunate to hold national and international roles which have allowed me to work with several pioneers and leaders as well as younger rising stars. The common theme is that success relies not on individuals, but on teams of motivated, talented people working together towards a common goal. The best advice I received was to “always listen to the patient”. Simple advice, but easy to forget in the temptation to perform endless scans and treat images.

It continues to be an honor to work with my venous colleagues as part of the Charing Cross (CX) Executive team (with Stephen Black and Erin Murphy).

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

After a century of stagnation, there have been major advances in venous diagnosis and treatment over the last 20 years. Recent advances in deep venous interventions such as stents and thrombectomy are exciting, but it is important to remember that most of the venous disease diagnosed and treated worldwide is superficial reflux. For this reason, the development of endovenous modalities to treat superficial reflux has had an enormous impact and massively increased accessibility of superficial venous procedures for patients with venous disease. This is particularly the case for the frail population with C5 and C6 disease, who can virtually all be treated with endovenous ablation procedures.

What are the biggest challenges currently facing the venous world?

In many ways, the venous space has never been better in terms of innovation, technology, and research. For the first time, we have the interventions capable of treating the complex array of deep and superficial venous pathologies we encounter. However, case selection remains an enormous challenge.

This is illustrated by the ongoing debate regarding early thrombus removal for acute iliofemoral deep vein thrombosis (DVT), where the published randomized controlled trials (RCTs) have been underwhelming in showing benefit for early thrombus removal.

Virtually all venous specialists acknowledge that some patients derive enormous clinical

FACT FILE CURRENT APPOINTMENTS • Consultant vascular and endovascular surgeon, Cambridge University Hospitals NHS Foundation Trust • Clinical lead, Cambridge Vascular Unit • Honorary senior lecturer, Imperial College London • Executive board member, CX Symposium • President, RSM Venous Forum EDUCATION 2012: FEBVS European Board of Vascular Surgery 2009: FRCS Royal College of Surgeons (Eng) 2007: MD University of Bristol 1999: MB ChB University of Bristol

benefit from early thrombus removal, but we struggle to define who. The same applies to pelvic vein embolization, deep venous stenting and perforator ablation procedures. Perhaps research efforts should focus on which patients to treat, rather than which stent/catheter/ thrombectomy device/catheter to use.

The explosion of new devices to treat venous disease does present a challenge as device introduction is often driven by commercial, rather than clinical motivations.

The ongoing debate regarding appropriate care and avoidance of overtreatment is as strong as ever. Unfortunately, the greatest driver of venous treatment strategy is reimbursement, rather than evidence-based best care.

Perhaps the biggest challenge relates to a lack of workforce in many countries (including the UK) to assess and treat venous disease. Traditional models of care need to be challenged, as there is an enormous unmet need, particularly with the management of venous leg ulceration, post-thrombotic syndrome and pelvic venous disease.

Could you outline some of the trials you are currently involved in?

The venous field is a vibrant space for ongoing clinical research, and I am fortunate to be involved in several exciting projects at present. The THRIVE study is a multicenter UK RCT aiming to establish whether thromboprophylaxis reduces the risk of venous thromboembolism (VTE) post endovenous ablation procedures. A new venous ulcer platform model has been developed in the UK, which will hopefully allow leg ulcer clinical trials to be performed easily and without extensive infrastructure difficulties. In Cambridge, we are looking at artificial intelligence technologies to improve diagnosis and predict outcomes after venous treatments—watch this space!

Along with Kathy Gibson, I am global principal investigator for the VenaSeal Spectrum program, which consists of three distinct studies to evaluate the role of VenaSeal (Medtronic) closure in modern endovenous practice. Two of the studies are randomized clinical trials comparing VenaSeal to surgical stripping and endovenous thermal ablation. We are excited to share the results in podium-first presentations at CX 2024. While no clinical trial is perfect, randomized clinical trials form the foundation of daily clinical practice.

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

I think the recent development of multiple thrombectomy devices for iliofemoral DVT is enormously significant as the avoidance of lytic infusion should make early thrombus removal procedures much safer. While I recognize the inconclusive results from ATTRACT, CAVA and CaVenT trials, there needs to be a robust, prospective evaluation of thrombectomy versus anticoagulation alone.

RCTs are planned in this field, but given the enormous criticism of previous trials (mainly due to selection bias/lack of equipoise), I wonder if more innovative study designs (such as observational studies with embedded RCTs) may be a more elegant and productive way to answer the question.

We are also in desperate need of large, prospective deep venous stenting trials, to provide robust evidence to support these increasingly popular interventions. Hopefully,

Issue 17 / February 2024

9

alisonlang.com

Interview

C-TRACT will help move the needle, but I fear that this trial will be besieged by many of the same challenges that befell ATTRACT.

What will you take away from your role as president of the Royal Society of Medicine (RSM) Venous Forum?

I have had the honor of being the president of the RSM Venous Forum since late 2021 and the role has involved educational and political activities. I have realized that provision of venous care is nowhere near where we would like it to be in the UK, or internationally.

COVID-19 has had a big, negative impact, but it is frustrating that we are having the same arguments with payors and policy makers as 20 years ago. However, through multidisciplinary education and events, we can continue to create enthusiastic teams of skilled professionals who can become the next generation of activists and educators.

Could you outline one of your most memorable cases?

I vividly recall the case of a young male

patient who had suffered with a venous ulcer for more than 20 years. He had readily treatable venous obstruction and superficial reflux and after uncomplicated deep vein stenting and great saphenous vein (GSV) ablation, his ulcer healed within two months.

He was memorable because the ulcer had an enormous impact on his life. He had confidence and mental health issues, which resulted in the breakdown of his marriage. He lost his job. The venous interventions and ulcer healing was the catalyst to change his outlook on life for the better. This case is an important reminder of how severely venous disease/ ulceration can impact patient quality of life.

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

A career in medicine is undoubtedly hard work and requires enormous motivation. The last few years have been very tough for healthcare professionals, particularly those working in state health systems. However, being a doctor is an enormous privilege and I am reminded regularly how we can transform people’s

“It is an enormous privilege to work in healthcare and to be trusted by patients and families during their most difficult times.”

lives for the better. A career in medicine is incredibly varied and very sociable, with the opportunity to work around the world. If you want to make a difference, then medicine is a fantastic career choice. Venous disease has seen a massive increase in interest in recent years. While there is still a long way to go, we now have exciting diagnostics, interventions and research opportunities, making it an excellent specialty choice. There is an enormous unmet need and a growing group of passionate and like-minded venous specialists who are inspiring the next generations.

What are your hobbies and interests outside of medicine?

Outside work, I try to spend as much time with my family as possible. My wife Tanya continues to demonstrate superhuman levels of tolerance, and my daughters Olivia and Clara are a constant source of joy and teenage drama. Family holidays are spent almost exclusively in France, where we all feel at home. We enjoy skiing, sport in general including cricket, and traveling.

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February 2024 / Issue 17

Conference Coverage VEINS/VIVA

Computer-assisted vacuum thrombectomy system for patients with pulmonary embolism demonstrates “rapid, statistically significant” improvement in RV/LV ratio Patients undergoing computer-assisted vacuum thrombectomy with the Indigo aspiration system (Penumbra) for pulmonary embolism (PE) showed 2.7% rates of both major adverse events (MAEs) and major bleeding at 48 hours post-procedure alongside “a significant reduction” in right ventricle/left ventricle (RV/LV) ratio of 25.7%, according to an interim analysis of the STRIKE-PE study.

“T

he STRIKE-PE dataset is very encouraging as it confirms the promise of computer-assisted vacuum thrombectomy to restore blood flow quickly, safely and effectively while also showing promising, prompt and lasting improvement in patient outcomes,” said Ido Weinberg, a vascular medicine specialist at Massachusetts General Hospital in

Worcester, USA, who presented the data during a late-breaking science session at the Vascular Interventional Advances (VIVA) 2023 annual meeting (Oct. 30– Nov. 2) held in Las Vegas, USA. The interim analysis—comprising 150 patients of a real-world, multicenter study at up to 55 global centers aimed at evaluating 600 subjects with acute PE symptoms of ≤14 days and a RV/

Akura thrombectomy system for PE appears safe and demonstrates reduction of RV/LV ratio in first-inhuman study Results from a first-in-human, prospective, single-arm study of the Akura Medical thrombectomy system (Akura Medical) for pulmonary embolism (PE) were revealed at The VEINS 2023 (Oct. 28–30, Las Vegas, USA).

PRESENTER JAY MATHEWS (MANATEE Memorial Hospital, Bradenton, USA) detailed that the study enrolled five patients at two sites in Tbilisi, Georgia, in March and April 2023 to evaluate the safety and performance of percutaneous mechanical thrombectomy using the Akura Medical thrombectomy system. The Akura system is a low-profile system that combines targeted clot removal with a platform capable of providing objective data on hemodynamics to help clinicians understand the relationship between thrombus removal and alleviation of pulmonary artery pressures.

The key inclusion criteria included medically eligible patients aged >18 years with clinical symptoms consistent with acute PE or sPESI (simplified PE Severity Index) ≥1, with symptom onset ≤14 days, proximal PE confirmed by computed tomography angiography (CTA), a stable heart rate <130 bpm prior to procedure, and systolic blood pressure ≥90mmHg, with a right ventricular/left ventricular (RV/LV) ratio >0.9. Five patients were

Ido Weinberg at VIVA 2023

LV ratio ≥0.9—demonstrated that mean RV/LV ratio significantly decreased from 1.39 at baseline to 1.01 at 48 hours post-thrombectomy. Four patients experienced MAEs within 48 hours.

From baseline to 48 hours, the median clinical measures of heart rate and respiratory rate significantly decreased, Weinberg informed VIVA 2023.

In terms of secondary outcomes out to 90 days, Weinberg said the dyspnea scale significantly improved from presentation to discharge and from presentation to the three-month follow-up marker. Additionally, the sixminute walk test distance significantly improved from discharge to 90-day

enrolled, treated, and followed through seven-day follow-up.

The patients successfully received treatment with the Akura thrombectomy system to remove pulmonary thrombus in the pulmonary vasculature. The average procedure time from anesthesia start to closure was 117±50 minutes, with an average fluoroscopy time of 30±21 minutes (range, 13–68 minutes). Total blood loss was 247±80mL on average, with 189±120mL of contrast used per procedure. After 48 hours, the RV/LV ratio decreased by 0.35 from 1.29±0.15 to 0.94±0.12 (p<0.05; 26.85% reduction). Through seven-day follow-up, there were no deaths, device-related major bleeding, or device-related adverse events.

Mathews concluded that the Akura thrombectomy system for PE appears safe, and preliminary evidence shows that this platform technology leads to a significant reduction in RV/LV ratio and thrombus burden.

Jay Mathews at The VEINS 2023

follow-up.

“STRIKE-PE interim results demonstrated a rapid, statistically significant improvement in RV/LV ratio and clinical measures while maintaining safety,” Weinberg concluded. “At 90-day follow-up, treatment with computerassisted vacuum thrombectomy with the Indigo Aspiration system improved patients’ functional capacity.”

STRIKE-PE will follow patient outcomes out to one year.

“At 90-day followup, treatment with computerassisted vacuum thrombectomy with the Indigo aspiration system improved patients’ functional capacity.”

After

48 hours, the RV/LV ratio decreased by

0.35 from

1.29±0.15 to

0.94±0.12

Issue 17 / February 2024

Duo venous stent system shows 90.2% primary patency at 12 months, VIVID trial reveals The Duo venous stent system (Vesper Medical/Philips) showed a 98.7% freedom from major adverse events (MAEs) at 30 days and 90.2% primary patency at 12 months, results from the VIVID trial have revealed.

THE DATA—WHICH COVERED 162 subjects with non-thrombotic, acute thrombotic or chronic post-thrombotic clinically significant venous outflow obstruction—were presented during The VEINS 2023 (Oct. 28–30, Las Vegas, USA)

by Mahmood Razavi (St Joseph Heart & Vascular Center, Orange, USA), who highlighted how the trial provided “more clinical evidence in terms of durability and clinical improvement in these patients with venous outflow obstruction and venous stenting.”

The prospective, multicenter, single-arm, nonblinded clinical trial is designed to investigate the safety and efficacy of the Duo system as compared to pre-defined performance goals related to stenting of iliofemoral venous outflow obstructions.

The 98.7% freedom from MAE safety endpoint

Conference Coverage

exceeded the peer-reviewed literature-driven performance goal of 89% with a highly significant p value, Razavi told The VEINS. The 12-month primary patency rate of 90.2% similarly exceeded its Mahmood Razavi performance goal of 77%, he added.

“As expected, the best outcomes were in the nonthrombotic patients, followed by the acute thrombotic patients followed by the post-thrombotic patients,” Razavi explained.

He outlined significant sustained clinical improvement in terms of CEAP (clinical, etiology, anatomy, pathophysiology) classification, Villalta score and venous clinical severity score (VCSS).

“The safety and efficacy of the stent system were established, and the endpoints were met,” Razavi concluded.

“As expected, the best outcomes were in the non-thrombotic patients, followed by the acute thrombotic patients followed by the postthrombotic patients.”

One-year CLOUT data demonstrate low rate of PTS following treatment with ClotTriever David Dexter (Sentara Vascular Specialists, Norfolk, USA) shared one-year data from the CLOUT registry at The VEINS 2023 (Oct. 28–30, Las Vegas, USA).

LONG-TERM, PROSPECTIVE OUTCOME data after mechanical thrombectomy for deep vein thrombosis (DVT) are lacking. The CLOUT (ClotTriever Outcomes) registry is a prospective, multicenter study evaluating patient outcomes for proximal lower extremity DVT treated with the ClotTriever system (Inari Medical).

CLOUT is the largest mechanical thrombectomy study in the field of DVT, said Dexter, and although positive results have been previously published, this is the first report of one-year outcomes for all available patients. Patients in CLOUT were aged ≥18 years and enrolled regardless of bilateral disease, duration of symptoms, prior treatment failure for the current DVT event, or contraindications to thrombolytic therapy. A total of 310 patients completed the one-year followup visit.

One year after mechanical thrombectomy, moderate-to-severe post-thrombotic syndrome (PTS; Villalta score ≥10) was observed in 8.8% of treated limbs. The overall PTS rate (Villalta score ≥5) was 19.3%. Venous patency, as measured by the presence of flow with normal or partial compressibility on duplex ultrasound, was observed in 94.2% of cases.

Additionally, significant improvements from baseline in revised Venous Clinical Severity Score, Numeric Pain Rating Scale score, and EQ-5D questionnaire score were demonstrated.

In the real-world, all-comer CLOUT registry,

David Dexter at The VEINS 2023

one-year outcomes demonstrate a low rate of PTS following treatment with the ClotTriever system, which was complemented by patient-centric improvements in symptom relief and quality of life.

Study follow-up through two years is ongoing.

Dexter stated that these favorable clinical outcomes highlight the need for randomized controlled trial data comparing mechanical thrombectomy with standard of care anticoagulation treatment. The recently initiated randomized controlled DEFIANCE trial will compare the ClotTriever system to anticoagulation for the treatment of symptomatic iliofemoral DVT.

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Six-month outcomes from phaseone trial of anti-inflammatory drug to assess benefit in acute DVT patients demonstrate ‘promise’ THE OPEN-LABEL PHASE OF THE DEXTERITY-AFP trial investigating the Bullfrog microinfusion device—which involves the perivenous injection of the anti-inflammatory drug dexamethasone to improve patency and post-thrombotic syndrome (PTS) six months after thrombus removal in symptomatic deep vein thrombosis (DVT) patients— has shown positive results.

That’s according to late-breaking data revealed during The VEINS 2023 meeting (Oct. 28–30) in Las Vegas, USA, by David J Dexter, co-principal investigator and a vascular surgeon at Sentara Healthcare in Norfolk, USA. From a trend standpoint, Dexter told attendees, the 20-patient cohort, fully enrolled with six months of follow-up, showed a 5% rate of any PTS and currently no patients through 12 months with moderate-tosevere PTS. The femoropopliteal segment study is moving in its second phase during which 60 patients will be enrolled 1:1 in a dual-blinded randomized controlled trial (RCT), and is considered the first known to investigate local drug delivery intended to reduce venous inflammation associated with DVT. Of the total 21 patients initially enrolled in the first phase, one withdrew after one-month follow-up.

In terms of safety, there were no device or drugrelated serious adverse events observed. The primary efficacy endpoint—clinically relevant loss of primary patency—will be examined as combined with the RCT phase, the investigators revealed. Of the 21 patients followed at one month, 19 (90.5%) had fully compressible and two had partially compressible common femoral veins. Other key secondary endpoint data for the 20 participants with in-window, sixmonth follow-up included reduction from baseline to six months in average Villalta score (7.3 to 1.6) and 10-point pain score (3.2 to 0.5).

“Iliofemoral DVT continues to have poor outcomes,” Dexter told The VEINS 2023.

“Femoropopliteal DVT has been neglected because we have really poor therapeutic outcomes yet they compromise more than half of DVT cases we see.

Inflammation appears to be linked to vein wall scarring and PTS. Dexamethasone appears to show really promising results both in pre-clinical studies as well as in our single-arm, early-phase data.

The biomarker work, the compressibility work and the Villalta score all show really favorable early outcomes.”

“Femoropopliteal DVT has been neglected because we have really poor therapeutic outcomes yet they compromise more than half of DVT cases we see.”

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February 2024 / Issue 17

Conference Coverage

Intravenous anesthesia delivery during varicose vein treatment proves safe and reduces pain scores, researcher reports A new intravenous anesthesia delivery technique used during endothermal ablation for varicose veins demonstrated comparatively low pain scores according to first-in-human (FIH) data recently presented at the 2023 VEITHsymposium (Nov. 14–18, New York, USA).

THE INVESTIGATIONAL SOLUTIO study showed two “mild” device catheter (MedVasc), which contains deficiencies and no serious adverse both a bent needle for tumescence events. Patients—eight women and one deployment through the vessel wall into man—underwent treatment by a single the perivascular space and endothermic vascular surgeon. They were recorded as fiber for ablation treatment, produced having a great saphenous vein median a median score of 5 (0–24) on the length of 41cm. visual analogue scale (VAS) in nine “The subject with the 24 VAS score consecutive patients in Sweden, Michael reported that the pain came from the Åkesson (Scandinavian Venous Centre, puncture site area in the lower leg,” Malmö, Sweden), an interventional Åkesson told the audience. “The radiologist and developer of the device, surgeon suspected this was caused by a told VEITH 2023. Åkesson founded dissection while accessing the vein. He MedVasc in 2013. generally considered the catheter to be He hailed the catheter as safe and easy to use, but with a safe and feasible solution a short learning curve. Two resulting in a single puncture minor device-related defects as opposed to several. were reported—low flow Traditionally, Åkesson rate in the long needle and observed, patients find the catheter with high friction anesthesia part of the ablation while pushing the needle treatment process unpleasant, out of the catheter. Both with VAS pain scores often problems will be resolved varying from 20–60. with the prototype.”

Results from the FIH During the four-week Michael Åkesson

Solutio catheter

“Two minor device-related defects were reported—low flow rate in the long needle and catheter with high friction while pushing the needle out of the catheter. Both problems will be resolved with the prototype.” follow-up period following treatment, no serious adverse events emerged and no signs of bleeding were reported, Åkesson added.

MedVasc notes on its website that,

during 2023, the company initiated the US Food and Drug Administration (FDA) 510k process to gain a regulatory pathway towards FDA clearance for the Solutio catheter.

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 17 / February 2024

Interview

“I still consider myself a student of leadership”: Retired Army General shares lessons on leading in a crisis “Expect—and prepare for—the unexpected,” Karen Gibson, Sergeant at Arms at the United States Senate, told the UIP 2023 World Congress (Sept. 17–21) during a keynote address entitled ‘Leadership in crisis’. In this interview with Venous News, Gibson summarizes some key messages from her talk at the Miami, USA, meeting and shares advice on how to be a good leader in a high-pressure working environment, extolling in particular the benefits of continuous learning.

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ibson has extensive leadership experience dating back to the earliest years of her military career.

“I had my first leadership position one year out of college,” she tells this newspaper. “I was 23 years old and leading 30 people, mostly men, all but two of whom were older than me.”

Gibson served in the US Army for 33 years, attaining the rank of Lieutenant General. Subsequently, she served as the Deputy Director of National Intelligence for National Security Partnerships, Director of Intelligence for US Central Command, Director of Intelligence for the multinational task force to defeat ISIS in Iraq and Syria, and Deputy Commanding General for the US Army Cyber Command before taking on her current role at the US Senate.

It was this considerable experience that made Gibson an apt choice for a keynote address on leadership at UIP 2023, and specifically leadership ‘in crisis’. She elaborates on the importance of her key piece of advice from the talk—to expect the unexpected: “Things we have not imagined, along the lines of the global pandemic, are going to happen and be disruptive, and leaders must lead their team through these crises.”

There are certain traits that are key to being a good leader, Gibson opines.

“True leadership needs to be authentic,” she says, explaining that, while it is a good practice to want to replicate certain traits, characteristics or practices of successful leaders, being a leader who is “genuine” is also important.

Alongside this, Gibson stresses that good leaders should, ideally, be transparent, consistent, confident, courteous and compassionate.

Gibson also underlines the importance of learning from past mistakes in order to hone one’s leadership style. “I have made a lot of mistakes,” Gibson admits, when asked about any pivotal moments during the course of her career that had a

particular influence on her leadership style. “The bigger the mistake, sometimes the more evident it is what you did wrong, which provides an opportunity to make corrections or to improve your leadership style.”

Another more specific pivotal moment for Gibson—which was the central vignette of her UIP talk—was how she and her team responded to Hurricane Irma when she was in a key leadership role for a military combatant command. She explains that while the command was operating in the Middle East it had to evacuate its headquarters in Florida due to the hurricane. “That incident really deeply informed my thinking about how to exercise leadership in a crisis, and now in my roles for life safety, emergency management, security and safety of the US Capitol, I really rely heavily on that experience to think about how we need to prepare, and how we might need to respond to unanticipated incidents at the Capitol.”

Decompress

There are parallels to be drawn between a career in the military and one in medicine, with Gibson sharing some lessons learned from her years leading in high-pressure environments that could be translated from one profession to another. She first notes that the continued demands of a high-pressure environment “can certainly take a toll, on one’s health, and also on one’s family and relationships, regardless of one’s field”. Gibson advises that it is important for leaders “not to take on too much,” and to be able to recognize when they might have done so.

Gibson believes in the importance of having the ability to “step away from the daily grind” when working in a high-pressure environment. She shares an example from her own experience: “Even when I was in a deployed environment, in a combat operation, I still had what I think of as my ‘bookends’—the beginning and

Karen Gibson

the end of my day and some rituals, whether it’s making my cup of coffee or reading 10 pages of a book before I go to sleep.”

During her UIP talk, Gibson underscored the importance, particularly in a crisis, of getting enough sleep, eating enough, and having the opportunity to exercise, meditate, or “decompress, in some way”. This is important not only for leaders but whole teams, Gibson points out. “A lot of times in a crisis people think that they can sprint and sustain this for long periods of time,” she says, “but that is not sustainable”.

Finally, Gibson emphasizes the necessity of having interests outside of one’s high-pressure working environment in order to create a “sense of balance”, and also of having confidantes, or “sounding boards” to

“Things we have not imagined, along the lines of the global pandemic, are going to happen and be disruptive, and leaders must lead their team through that.” share and discuss ideas with.

Gibson also reflects on how good leadership was influential during the early years of her professional life. “I was a career army officer, and so from the very beginning I was surrounded by leaders and expected to lead myself,” she recalls, stressing that good leadership was “imperative” in this environment. According to Gibson, an important part of being a good leader is taking the time to invest in the development of the people around you.

Some people who wish to become leaders will face barriers to assuming a leadership role, Gibson recognizes.

“Personally, I don’t feel I’ve faced any barriers to leadership,” she reflects, detailing that her role as an officer in the military was centered around leading from the very beginning. For

others, however, the opportunities may simply not be available. “I see this in my own organization,” says Gibson, who oversees 900 members of staff in the Senate Sergeant at Arms and “some of them work in areas where there are just not leadership opportunities”.

There can be structural limits in an organization to leadership opportunities, Gibson notes. She explains: “It can be a team of 10 people with one supervisor and that person’s been there for decades and isn’t going anywhere.” Despite this, however, Gibson is keen to stress that leadership can be demonstrated in other ways if the structural limits of an organization are an inhibiting factor. She advises seeking leadership opportunities outside the confines of a principal professional role, for example— perhaps in a volunteer organization or a community service organization.

“There are a lot of different ways that one can demonstrate or start to work on leadership if that is denied to them based on organizational structure.”

Delegate

Gibson also addresses some common mistakes leaders make. One she often sees is people who think they need to do everything themselves. This is particularly common in leaders who are moving to a more advanced leadership position with a larger team.

“You cannot keep doing everything yourself” in this situation, Gibson says. “Some people have difficulty either letting go of all the details or delegating and trusting people under them,” she adds, noting that this can be a “key developmental hurdle” for some leaders.

Another common mistake Gibson points out, particularly among junior leaders, is a belief that they must be universally liked. “Everyone is not going to like you,” she stresses, “and they’re not always going to like all of your decisions”. There is also a flipside to this, Gibson notes, which is a leader who does not care what people think and “doesn’t consider the human aspect” of their decisions. “That can be another challenge,” she says, which tends to come later in one’s career.

“I would say become a student of leadership,” Gibson advises anyone looking to assume a leadership role at some point in their career.

“I still consider myself a student of leadership,” Gibson opines, underscoring the continuous nature of learning and honing leadership skills over the course of one’s career.

“Watch the people around you, or the leaders that you observe, and see what practices you would want to adopt, or would not want to adopt” she advises, noting that this is something she continues to do.

In addition, Gibson emphasizes the importance of seeking mentors when looking to assume a leadership role.

“It’s important to have people who can guide and advise you,” she says.

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February 2024 / Issue 17

Journal Highlights

“Significant efforts” needed to improve level of evidence for management of lower extremity venous outflow obstruction A large international Delphi consensus on the management of lower extremity venous outflow obstruction has been published, identifying “clear areas of agreement and disagreement” between experts to support future research and writing of guidelines in this field. The consensus document appeared as an Editor’s Choice paper in the February edition of the European Journal of Vascular and Endovascular Surgery (EJVES).

AUTHORS STEPHEN BLACK (Guy’s and St Thomas’ NHS Foundation Trust, London, UK) and colleagues, on behalf of the International Venous Delphi Consensus Study Group, note that a “rapid” evolution of the treatment for lower extremity venous outflow obstruction has not been matched by a parallel proliferation of data. Instead, they write, “the pace of growth has occurred with a paucity of available evidence to support treatment”. This has been aggravated by the difficulties associated with running large randomized controlled trials. As a result, the authors state that “best practices for optimal patient outcomes are not well established”.

The purpose of the present study was to obtain consensus on management criteria for patients with lower extremity venous outflow obstruction.

Black et al detail that the study was conducted as a two-round Delphi consensus. They note that statements addressed imaging, symptoms and other baseline measures, differential diagnosis, treatment algorithm, indications for stenting, inflow and

outflow assessment, successful procedural outcomes, post-procedural therapies and stent surveillance, and clinical success factors.

The authors relay that six expert physicians prepared 40 statements as part of the first round, while an expanded panel of 24 physicians prepared 80 statements for the second round. All statements were sent to a preidentified group of venous experts who met qualifying criteria.

Black and colleagues note that a nine-point Likert scale was used and consensus was defined as ≥70% of respondents rating a statement between seven and nine (agreement) or between one and three (disagreement).

Round one results were used to guide rewording and splitting compound statements for greater clarity in round two.

The authors share that 75 of 110 (68%) experts responded in round one of the Delphi consensus, and 91 of 121 (75%) responded in round two.

They report that round one achieved consensus in 32/40 (80%) statements, with consensus not reached in the

treatment algorithm section. Round two achieved consensus in 50/80 (62.5%) statements.

Black et al specify that statements reaching consensus were imaging (2/3, 66%), symptoms and other baseline measures (12/24, 50%), differential diagnosis (2/8, 25%), treatment algorithm (10/17, 59%), indications for stenting (10/10, 100%), inflow and outflow assessment (2/2, 100%), procedural outcomes (2/2, 100%), post-procedural therapies and stent surveillance (5/7, 71%), and clinical success factors (5/7, 71%).

“Focused and coordinated” research required

In their concluding remarks, the investigators summarize that the areas in which consensus was not achieved must be the focus of venous disease research going forward. “This study has demonstrated that while there are several areas where venous experts agree on the assessment and management of lower extremity venous outflow obstruction, there are multiple domains where consensus was not achieved,” they write. “This underlines that treating venous disease remains a controversial area and requires focused and coordinated research efforts across specialties to answer several unresolved clinical questions. The Delphi consensus has identified those areas in which these efforts should be focused.”

Black and colleagues state in the discussion section of their EJVES paper that this new Delphi consensus

US study highlights racial and ethnic disparities in the placement of “overused” IVC filters

A

nationwide US study, recently published in the Journal of Vascular Surgery: Venous and Lymphatic Disorders (JVS-VL), showed that Black patients had the highest inferior vena cava (IVC) filter placement rate per 100,000 persons compared with white and Latino patients in the USA from 2016 to 2019.

“Given the known long-term complications and uncertain benefits of IVC filters, coupled with the 2010 US Food and Drug Administration [FDA] safety warning regarding adverse patient events for these devices, proactive measures should be taken to address this disparity among the Black patient population to promote health equity,” authors Jordan J Juarez (Philadelphia, USA) and colleagues remark.

Juarez, a medical student at Lewis Katz School of Medicine at Temple University, et al detail that they performed a retrospective review of National Inpatient Sample data to identify adult patients with a primary discharge diagnosis of acute proximal lower extremity deep vein thrombosis (DVT) from January 2016 to December 2019, including self-reported patient race and ethnicity.

The authors note that weighted multivariable logistic regression was used to compare IVC filter use by race

and ethnicity. The regression model was adjusted for patient demographics, hospital information, weekend admission, and clinical characteristics.

Juarez and colleagues report in JVS-VL that, of 134,499 acute proximal lower extremity DVT patients included in the review, 18,909 (14.1%) received an IVC filter. Of the patients who received an IVC filter, 12,733 were white (67.3%), 3,563 were Black (18.8%), and 1,679 were Latino (8.95%). They relay that IVC filter placement decreased for all patient groups between 2016 and 2019.

After adjusting for the US population distribution, the investigators explain that the IVC filter placement rates were 11 to 12 per 100,000 persons for Black

“Future work should assess whether clinical bias for adherence to other treatments could be perpetuating this disparity in minoritized communities.”

“represents the most widespread survey of experts to date” and “provides an important benchmark of consensus that highlights areas where further research is needed to clarify treatment for patients with venous disease”.

In their analysis, the authors underline the fact that a lack of consensus among experts was most common in statements relating to treatment. This, they write, demonstrates a “clear need” to focus future research on the treatment algorithm and clinical outcomes—including health economic outcomes—to help ensure treatments become “more robust”.

Overall, the investigators stress that consensus was achieved for most statements in both rounds of the Delphi process despite a lack of high-quality evidence guiding treatment. They reiterate, however, that a “clear lack” of consensus in several areas highlights the need for “significant efforts” to improve current evidence levels.

“Treating venous disease remains a controversial area and requires focused and coordinated research efforts across specialties to answer several unresolved clinical questions.”

patients, seven to eight/100,000 persons for white patients, and four to five/100,000 persons for Latino patients. They share that the difference in IVC filter placement rates was statistically significant between patient groups (Black patients versus white patients, p<0.05; Black patients versus Latino patients, p<0.05; Latino patients versus white patients, p<0.05).

In discusssing their findings, Juarez et al look into possible reasons behind the uncovered disparities.

“Although the reasons behind this racial and ethnic disparity need further investigation,” they write, “factors such as clinician bias related to concern for medication adherence could play a role.”

The authors also consider their results more generally in the context of IVC filter usage in the USA. They point to previously reported literature showing an implantation rate much higher in the USA than in Europe (three per 100,000 persons based on data from five large European countries). Against this background, they comment that higher placement rates in the Black community are “especially concerning” and “suggest that IVC filters are still overused in the USA”.

Focusing next on some of the limitations of their research, Juarez and colleagues underscore the possibility of unmeasured confounders not assessed and adjusted for in their multivariable regression analysis, among others.

“Future work should assess whether clinical bias for adherence to other treatments could be perpetuating this disparity in minoritized communities,” the authors write as a forward-looking concluding remark.

Issue 17 / February 2024

Market Watch

Clinical News US FDA approves ENGULF US pivotal trial of Heˉlo thrombectomy system

Product News

Endovascular Engineering (E2) has announced US Food and Drug Administration (FDA) investigational device exemption (IDE) approval for its ENGULF US pivotal trial.

The study will evaluate the safety and effectiveness of the Hēlo thrombectomy system in treating pulmonary embolism (PE). The approval of the IDE follows the successful completion of the company’s 25-patient feasibility study.

“We are excited to be at the forefront of this innovative procedure with the completion of the ENGULF feasibility study. This significant achievement sets the stage for definitive results in the ENGULF pivotal trial. The Hēlo thrombectomy system represents a significant leap forward in pulmonary embolism treatment, and I am enthusiastic about investigating its full potential in the upcoming phase of the study,” said Jay Giri (University of Pennsylvania, Philadelphia, USA) the national principal investigator (PI) for the ENGULF feasibility study.

“We intend to build upon the robust foundation of clinical success we’ve seen thus far, solidifying the Hēlo thrombectomy system’s role as a transformative force in the treatment of pulmonary embolism,” said Andrew Klein (Piedmont Heart Institute, Atlanta, USA), the national PI for the ENGULF pivotal study.

Mike Rosenthal, CEO of E2, commented: “The positive results from our feasibility study give us confidence as we enter the pivotal phase. The Hēlo system introduces a differentiated technology with the potential to advance PE treatment options. Embarking on our ENGULF pivotal trial is a significant step, further validating the system’s safety and efficacy. It advances our efforts toward introducing this innovative technology to the market, ultimately helping patients with PE.” The Helo thrombectomy system for PE is for investigational use only and is not approved for commercial use, E2 advises. The device is not available for sale.

Enrollment complete in APEX-AV study of mechanical aspiration system for acute PE

Patient enrollment is now complete in the APEX-AV trial evaluating the safety and efficacy of the AlphaVac F1885 (AngioDynamics) multipurpose mechanical aspiration system for the treatment of acute intermediate-risk pulmonary embolism (PE).

APEX-AV is a single-arm investigational device exemption (IDE) study involving 122 patients with confirmed acute, intermediate-risk PE across 25 hospital-based sites in the USA. The primary efficacy endpoint of APEX-AV is the reduction in RV/ LV ratio between baseline and 48 hours post-procedure. The primary safety endpoint is the rate of major adverse events (MAEs), including devicerelated death and major bleeding within the first 48 hours. Patients will be followed for 30 days post-index procedure.

AngioDynamics initiated the study in partnership with the Pulmonary Embolism Response Team (PERT) Consortium. It is led by co-principal investigators William Brent Keeling, associate professor of surgery at the Emory University School in of Medicine in Atlanta, USA, and immediate past president of the PERT Consortium, and Mona Ranade, assistant professor of interventional radiology at the David Geffen School of Medicine at the University of California, Los Angeles, USA. “Data from the APEX-AV study expand the current body of literature on the safety and efficacy of mechanical thrombectomy and broaden the PE treatment options, particularly in this space,” said Ranade.

The AlphaVac F1885 system is cleared for the removal of thromboemboli from the venous system. APEX-AV was designed to provide safety and efficacy data for a clearance specific to PE.

VVT Medical and Methapharm sign a distribution agreement for the marketing of ScleroSafe in the USA

VVT Medical recently announced the signing of a strategic distribution agreement with Methapharm, a specialty pharmaceutical company.

According to a press release, this collaboration marks a pivotal moment in the realm of varicose vein treatment, leveraging the strengths of both entities for the marketing of VVT Medical’s ScleroSafe platform in the USA. The ScleroSafe platform received its 510(k) clearance from the US Food and Drug Administration (FDA) in June 2023, which laid the foundation for this strategic partnership. ScleroSafe is a novel medical device that utilizes a dual syringe technique, VVT Medical notes.

The press release continues that Methapharm is uniquely positioned to spearhead the distribution of ScleroSafe, due to its extensive expertise in varicose veins and its relationships with key stakeholders and physicians in the USA. The collaboration is further fortified by the strong synergy between the two companies, the release adds, sharing application in the same procedure for efficient, non-thermal, non-tumescent (NT-NT) treatment and management of varicosities in superficial veins.

Erez Tetro, CEO of VVT Medical, stated: “ScleroSafe holds the promise of transforming varicose vein treatment, providing patients with a safe, effective, and straightforward option.” He emphasized the collaboration with Methapharm, saying: “We have strong confidence in the positive influence our product can bring to the lives of many throughout the USA, and we consider Methapharm as the ideal collaborator to realize this vision.”

Craig Baxter, CEO of Methapharm stated: “We at Methapharm are very excited to form this strategic relationship with VVT Medical, and we look forward to adding ScleroSafe to our offerings. We believe it will contribute significantly to our efforts to continually offer the best possible patient care.”

AngioDynamics’ AlphaVac system

Vein360 receives US FDA clearance to reprocess the Philips Visions PV 0.035, 0.018, and 0.014 digital IVUS catheters

Vein360 has announced it received US Food and Drug Administration (FDA) 510(k) clearance for reprocessing the Philips Visions PV 0.035 digital intravascular ultrasound (IVUS) catheter in June of 2023 and the Visions PV 0.018 digital IVUS catheter in August of 2023. In addition, the company received FDA 510(k) clearance to reprocess the Visions PV.014P RX digital IVUS catheter, reprocessed Eagle Eye Platinum RX digital IVUS catheter, reprocessed Eagle Eye Platinum ST RX digital IVUS catheter, and reprocessed Visions PV.014P RX digital IVUS catheter in October 2023.

Vein360’s co-founder and chief medical officer Chris Meyer commented in the company’s press release: “As independent endovascular physicians, our reimbursement for IVUS has eroded so much that we are often paid less than the cost of the catheter. This hurts our ability to work autonomously in our own OBLs [officebased labs] and ASCs [ambulatory surgery centers]. It was clear to us that the Philips IVUS with its phased array transducers was easier to use and had superior image quality when compared to Boston’s Opticross. Our goal in the submissions was to get this superior technology in the hands of physicians while allowing them to maintain profitability when performing IVUS. At Vein360, we will continue to work tirelessly to reduce procedural cost so that physicians can focus on patient care.”

Philips’ Visions PV 0.035, 0.018, and 0.014 digital IVUS catheters

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

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

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

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

May 8–11 Venous Symposium New York City, USA

venous-symposium.com

May 28–31 Leipzig Interventional Course (LINC) Leipzig, Germany leipzig-interventional-course.com/ visitors/linc-2024

June 19–22 Vascular Annual Meeting (VAM) Chicago, USA vascular.org/vam-2024

June 27–29 24th European Venous Forum (EVF) annual meeting Athens, Greece europeanvenousforum.org

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

myavls.org/annual-congress-2024. html

CX2024 Inhouse Programme Highlights - VEN - Venous Hightlights - Feb 2024-v2.pdf

CONTROVERSIES

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30/01/2024

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CHALLENGES

CONSENSUS

Vascular & Endovascular

Controversies Update Aortic Controversies

Peripheral Arterial Controversies

Venous & Lymphatic Controversies

Carotid & Acute Stroke Controversies

Vascular Access Controversies

The Hurting Leg Controversies

Vascular Trauma Controversies

23–25 APRIL 2024 TUESDAY-THURSDAY NEW VENUE, ExCeL LONDON, UNITED KINGDOM

EARLY BIRD DISCOUNT ENDS 25 FEBRUARY

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Programme Highlights

Venous & Lymphatic Controversies

Venous & Lymphatic CONTROVERSIES

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• Debate: Treatment of non-thrombotic iliac vein lesions in C3-C6 disease is supported by the clinical evidence Wednesday, 24 April • Podium First: Results of the randomised clinical trials comparing cyanoacrylate glue closure with thermal ablation and surgical stripping Wednesday, 24 April • Venous Workshop: Hands-On Thermal Ablation Course – Part of the Venous Workshop Tuesday, 23 April

VENOUS & LYMPHATIC EXECUTIVE BOARD:

STEPHEN BLACK

MANJ GOHEL

ERIN MURPHY

45 YEAR LEGACY OF VASCULAR EDUCATION CONTINUES EDUCATION

INNOVATION

EVIDENCE