First & only

The first and only DCB with superior, sustained results at 36 months for AV fistula lesions versus PTA.1,2

Separate trials evaluating target lesion primary patency for IN.PACT AV DCB at 36 months and Lutonix™* DCB at 24 months.†

36-month results

vs. PTA at 36 months vs. PTA at 36 months

26.9%

2.5% vs. PTA at 24 months months p = 0.087

*Third-party brands are trademarks of their respective owners.

0.087

24.4%

24.4%

43.1%

43.1% Standard

28.6%

28.6% continued from page 1 clear,” said Conte, “that an endo[vascular]-first, or, even more strikingly, endo-only approach, to all patients with CLTI is simply not evidence-based care. And Centers of Excellence must be skilled in both techniques of revascularization.

†Primary patency endpoints are defined differently; results are from different studies and may vary in a head-to-head comparison; charts are for illustration purposes only.

‡IN.PACT AV Access Trial: Target Lesion Primary Patency Rate was defined as freedom from clinically driven target lesion revascularization (CD-TLR) or access circuit thrombosis measured through 36 months (1,080 days) post-procedure.

§Lutonix AV Clinical Trial: Target Lesion Primary Patency was defined as freedom from clinically driven reintervention of the target lesion or access thrombosis measured through 24 months.

“Furthermore, informed decision-making with patients in this field should include the results of this evidence, and suitable patients should be offered the option of open bypass surgery, which I suspect is being under-offered and under-utilized in current practice. I think this trial should make that begin to change.

“It’s not surprising—it shouldn’t be surprising to us— that there are trade-offs between effectiveness and invasiveness. This is common in medicine and surgery, and, as I showed you, it is common in coronary artery disease. We need to embrace it and accept it. But I would suggest to you that one of the differences between coronary disease and vascular disease is that, as vascular surgeons doing both of these things, we have the opportunity to make these decisions. That could be either an advantage or burden, because we all have settled into our ways and our workflows, and may be unwilling to change what we currently do in practice.”

Conte then returned to an overarching message he also delivered at a BEST-CLI session hosted at the 2022 VEITHsymposium in New York last November: “I would suggest to you that centers doing less than 20% bypass in CLTI should really probably take stock about whether this is the best treatment for these patients,” he said.

Results from BEST-CLI showed that surgical bypass with adequate single-segment great saphenous vein (GSV) is a more effective revascularization strategy for patients with CLTI who are deemed to be suitable for either an open or continued from page 1 versity. The brilliance of that educational meeting, said Greenhalgh, inspired him to create something similar back in London, England, where the then-young vascular surgeon, soon-to-be surgery department chair, would birth the CX Symposium at Charing Cross in 1978.

“John Bergan was a master of education,” remarked Greenhalgh. “I tried to do what he and Jimmy Yao did. Jesse Thompson, from Dallas, came to the first CX meeting in 1978, which was focused on progress in stroke research. Even now, we have an acute stroke session, but the first was entirely about that area.”

Every year since, Greenhalgh recalls, he has been invited to the U.S. “and learned from the giants,” drawing particular attention to Houston, “the mecca of vascular surgery,” and its most famous cardiovascular son, Michael E. DeBakey, MD, with whom he had spent time the year prior to attending the Northwestern meeting. “Nothing after that equalled that amazing experience,” he said. “There was no comparison between the quality of care there seen anywhere else in the world.”

Thus, the CX cornerstone was laid. Over the years, the symposium was the setting for key moments in vascular surgery history. The European Society for Vascular Surgery (ESVS) was convened at the meeting in 1988, with DeBakey involved in prompting vascular societies of Europe to form a pancontinental group, Greenhalgh noted.

In the same decade, Andreas Grüntzig, MD, attended CX to talk about his version of a new balloon angioplasty system, and the symposium was an incubator for the development of key randomized-controlled (RCT) trials, such as the UK Small Aneurysm Trial, EVAR 1 and 2, and IMPROVE.

He references “interesting data” on the subject from Naseer Ahmad, MBChB, from Manchester Royal Infirmary in Manchester, England, which “would seem to suggest that in parts of the population where there is poverty, or inadequate facilities, that these are the areas in which the ‘hurting leg’ does not get the attention it should.” Suggesting what can be done to address this, Greenhalgh stresses that it is important to throw light upon this issue “in order to be able to get more people to get more timely intervention and have their leg saved.”

On the occasion of the 45th anniversary of CX, Greenhalgh ponders what is coming next for the meeting. In particular, he emphasizes the importance of future planning to ensure the concept of CX—education, innovation and evidence—continues.

To that end, he has recently appointed three new cochairs to the CX leadership team who will work alongside him to deliver the CX program going forward: Dittmar Böckler, MD, medical director of the Clinic for Vascular and Endovascular Surgery at University Hospital Heidelberg in Heidelberg, Germany; Andrew Holden, MD, director of interventional radiology at Auckland City Hospital in Auckland, New Zealand; and Erin Murphy, MD, director of the Venous and Lymphatic Institute at Sanger Heart and Vascular, Atrium Health in Charlotte, North Carolina. “We are covering the globe and all vascular subjects,” Greenhalgh said of the new leadership team. “There will be every opportunity for the CX concept to continue if that is considered to be worthwhile doing.” endovascular approach, the investigators reported. In patients without a suitable single-segment saphenous vein, both surgical and endovascular strategies were found to be effective in treating patients with CLTI, leading the investigators to conclude that there is “a complementary role for both revascularization strategies in these patients.”

BEST-CLI was a “landmark effort by [principal investigators] Alik Farber, Matt Menard and many others,” he said. Their passion and dedication “cannot be overstated in making this a reality over almost a decade, with much more to come from this trial.”

The work exhibited vascular surgeons taking the lead, he continued, “designing and executing science that is practice-changing science,” and “that needs to be recognized,” Conte added. It involved the BEST-CLI researchers taking lessons learned over the 20- to 30-year time span covering the development of evidence-based revascularization that he outlined in his address, he said, rolling them into the design of the trial. Conte, having summarized BEST-CLI’s headline results and delved into characteristics of its two cohorts to underscore his point, also noted the trial’s limitations—a theme of focus among its skeptics. “Any trial can only begin to answer certain questions, and raises many others,” he said. “I think it is currently the standard, landmark trial in our field from which we can launch forward with true evidence-based guidelines and approaches.”

In keeping with this long-standing tradition for being a theater for presentation and discussion of landmark advances in vascular care, this year will see CX play host to delivery of the first results from the much-anticipated BASIL-2 (Bypass versus angioplasty in severe ischemia of the leg-2) trial. They will be revealed by chief investigator Andrew Bradbury, MD, from the University of Birmingham in Birmingham, England, in the presence of representatives of the BEST-CLI (Best endovascular versus best surgical therapy for patients with critical limb ischemia) trial. A roundtable discussion is planned to include invited commentary from Eleni Whatley, from the U.S. Food and Drug Administration (FDA), and the British Secretary of State for Health, Steve Barclay. “At the moment of speaking, publication of the results will take place in The Lancet, which is a huge moment for CX,” he said. “We have had 45 years of a very global CX, and the tradition continues.” through the years

The CX anchor points to what he sees as one of the central pillars of the CX brand: its multidisciplinary appeal. “If you have an interest in—and are managing patients with—vascular disease,” he says, “there is something for you at CX.” This multidisciplinary approach is particularly important for the education of the next generation, Greenhalgh believes. “It is important to get as much experience alongside as many people as you can, so that you become a compendium of all those people that you have learned from,” he added.

Looking ahead, Greenhalgh believes one of the most pressing issues facing the vascular world is that of patients with a “hurting leg” not being seen by a professional in a timely manner. “My personal interest, not as yet proven, is a suspicion that patients whose legs hurt are at risk of amputation, and it is the responsibility of the vascular profession to do something about it,” he said.

Greenhalgh says he is not talking about patients who are referred to vascular specialists, but instead “the people who are not yet patients, whose legs hurt,” and who might not get advice from a doctor “simply because they think it is the aging process and they do not need to.” He continued: “They live in such an environment where they somehow do not get the advice that would enable them to have something done that would save their legs.”

This month, Corner Stitch highlights one of the papers recently presented at the Vascular and Endovascular Surgery Society (VESS) 2023 winter meeting in Whistler, British Columbia, Canada (Feb. 23–26). Nallely Saldana-Ruiz, MD, a senior vascular surgery fellow at the University of Washington in Seattle, and colleagues studied the trainee experience in open aortic reconstruction in the modern endovascular era—a topic on the minds of many trainees that sometimes influences how senior medical students rank programs. Here, she tells Christopher Audu, MD, what they found.

CA: Congrats on presenting at VESS 2023! Can you give us a synopsis of the study you presented?

NSR: Thank you. Presenting at VESS 2023 was truly a great experience. We were honored with the opportunity to share our work. Vascular surgery is a rapidly evolving field. While trainees around the country are exposed to many procedures during their years of training, some literature has demonstrated a wide variation in trainee experience and comfort with common procedures, including infrapopliteal revascularizations and in treating abdominal aortic aneurysm (AAA) disease. We noted a paucity of data on the trainee experience with complex aortic surgery, and wanted to understand what the complex thoracoabdominal aortic disease trainee experience was for recent vascular surgery graduates. We collected anonymous survey data from U.S. vascular surgery trainees who graduated in 2020. We wanted to get a better understanding of their experience during training, as well as learn about their current practice and any desire for additional training. Our study adds the unique perspective of early-career vascular surgeons and is strengthened by the anonymous nature of the survey. This allowed participants the opportunity to freely share their experience and how that experience may have shaped their current practice patterns. The limitations of the study include the small number of participants and the overall response rate. While it is certainly possible that the data can be biased by those who chose to answer the survey, we believe the responses provide a valuable insight into the early-career surgeon experience.

CA: What anecdotes or observations prompted this study?

NSR: The impetus for the study came from reading recent data, which demonstrated a wide variation in trainee experience with infrapopliteal bypasses and endovascular procedures. In their 2018 paper “Vascular fellow and resident experience performing infrapopliteal revascularization with endovascular procedures and vein bypass during training,” McCallum et al demonstrated a significant variation in trainee experience and comfort with treating infrapopliteal arterial disease. They suggest that a quarter of vascular surgery trainees were receiving insufficient exposure to infrapopliteal open and endovascular procedures. Their study found that 27% of vascular surgery trainees performed 10 or less infrapopliteal vein bypasses, while 29% performed 10 or fewer infrapopliteal endovascular procedures. Given these data and the paucity of data on the experience of trainees with treating complex aortic disease, we were compelled to ask the questions.

CA: From your analysis, what does your team think is the “number needed to learn” for trainees to feel comfortable treating complex aortic disease as junior attendings?

NSR: It is important to recognize that we never stop learning, even as we transition out of our trainee roles. It is also essential to acknowledge that the “number needed to learn” will vary from trainee to trainee. Learning is different from mastery, and if you ask five different surgeons the same question you will certainly get five different answers. Still, I think it likely takes anywhere between five to 10 cases before you feel comfortable with attempting to independently manage the pathology. For thoracoabdominal aortic aneurysm (TAAA) disease, learning how to approach and care for patients is challenging on many fronts. As an early-career surgeon, we will be faced with the complexities of decision-making and planning, all while carefully considering our patient’s physiology, anatomy, and fitness. Thus, “learning” is truly a long-term endeavor that is never complete.

CA: What do you propose that trainees who don’t have that sort of TAAA volume do to gain a certain level of comfort with this option—especially the open component?

NSR: The thoracoabdominal aortic disease training at the University of Washington is robust, and as trainees we are very fortunate to have such opportunities. Still, there is great benefit from cadaveric and simulation courses around the country for all trainees. Learning through simulation and didactics in a controlled environment, such as through courses like “The Big Apple Bootcamp,” the “Moore course,” and the open aortic training course at Houston Methodist Hospital, gives trainees unique exposure to the technical and clinical aspects of managing thoracoabdominal disease. However, I believe that there is no substitute for doing cases with those who manage and treat patients with thoracoabdominal disease often. learning the intricacies of treating complex pathology through the experience of others. These are skills that cannot be mastered with independent simulation alone. In fact, one of the key findings of our study was that the vascular graduates who continued to treat complex aortic disease in their practice were doing so with the participation of their partners. This highlights that as young surgeons we continue to learn from our mentors and colleagues.

CA: In your estimation, what was the most surprising finding from your study?

NSR: One thing we found most surprising was that while most trainees reported doing a low number of complex open and endovascular aortic cases during their training, many were performing them in practice. When we looked closer at the data, we noted that most of our trainees were doing these cases with partners. Early-career surgeons working closely with senior partners in early practice is not surprising at all, and our data helped us to understand that our current training paradigm is one in which we continue learning from others.

CA: I have a feeling you may have already alluded to it, but what is the biggest takeaway you’d like our readers to gain from this work?

CA: Should the Association of Program Directors in Vascular Surgery, SVS or other vascular surgical societies make this a priority and sponsor open or simulation courses to help address this training gap?

NSR: Simulation and access to additional training should be supported. Additionally, some of the most beneficial aspects of participating in simulations and didactics center on the learning that occurs through interaction. So much of our clinical growth comes from

NSR: Continuing to learn in the years following our formal trainee period is a critical part of our lifelong learning process. Still, because we found that the experience with the management of open and endovascular complex aortic disease treatment varied among trainees in our study, additional training in the form of simulation, dedicated courses, or “super fellowships” can provide effective educational adjuncts. Additionally, regionalization and the high-volume center—which provides dedicated care to patients with specific disease pathologies— may also afford the interested trainee the opportunity to learn a certain skillset in the form of visiting rotations and externships.