The Take Home: ISET
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The International Symposium on Endovascular Therapy, held Jan. 22 to 25 in Hollywood, Florida, tackled many of the hottest topics in endovascular intervention. To obtain the key take-home messages from ISET 2020, Healio spoke with experts in the field including Robert Lookstein, MD, MHCDL, FSIR, FAHA, FSVM, from Mount Sinai Health System; Jihad A. Mustapha, MD, FACC, FSCAI, from Advanced Cardiac and Vascular Centers for Amputation Prevention in Grand Rapids, Michigan, and Michigan State University College of Osteopathic Medicine; Constantino S. Peña, MD, FAHA, FSCCT, FSIR, from Miami Cardiac and Vascular Institute and Florida International University Herbert Wertheim College of Medicine; and Kenneth Rosenfield, MD, MHCDS, FACC, FAHA, MSCAI, from Massachusetts General Hospital.
All of Healio’s coverage from ISET 2020 can be found here.
Robert Lookstein, MD, MHCDL, FSIR, FAHA, FSVM
One of the overarching themes of ISET 2020 was multidisciplinary collaboration. This theme was well represented in sessions tackling critical limb ischemia and endovascular limb salvage cases showing the need for endovascular and open surgical specialists to collaborate, as well as in the management of patients with acute symptomatic venous thromboembolism, specifically pulmonary embolism, where there is an emerging evidence base that team-based approaches lead to improved outcomes. I walked away from the meeting feeling very assured that team-based care is on the minds of all vascular specialists and is here to stay. The paradigm shift is getting traction in the vascular community across the country and around the world.
One topic that was very salient during the meeting was the recent publication in the Journal of Vascular and Interventional Radiology of a meta-analysis which suggests that there is a correlation between the use of paclitaxel-coated balloons in the infrapopliteal arteries and amputation-free survival. There was a tremendous amount of conversation about this throughout the entire meeting. A number of physicians talked about it casually during breaks, a number of podium presentations tried to tackle this issue, and then there were a number of interviews with thought leaders trying to make sense of this new data set and how it is going to impact patient care. From my vantage point, there was a great deal of criticism focused on the methodology used in the meta-analysis. Specific observations related to the fact that a significant amount of included data was not peer-reviewed and that the products that were included are either not commercially available or have been removed from the global marketplace because of their inability to demonstrate clinical efficacy. In addition, there was a conspicuous omission of previous data sets that have evaluated paclitaxel-coated stents in infrapopliteal circulation, which now have long-term follow-up and appear to demonstrate clinical efficacy in avoiding amputation while having no adverse event profile that would cause concern to any practitioner. The majority of practitioners at the meeting appeared to not give this new data set serious consideration in terms of impact on their practice.
Increasingly at this meeting, it is becoming apparent that endovascular therapy across numerous disease states, including peripheral artery disease, VTE and repair of aortic and thoracic aneurysms, is becoming more recognized around the world as first-line therapy. All vascular specialists, regardless of training background, are embracing the concept and the techniques liberally. Adoption is increasing in North America and across the globe. Prospective outcomes research continually demonstrates very high levels of technical success, excellent mid- to long-term outcomes and incredible safety. This meeting reinforced that endovascular therapy and a team-based approach to vascular patient care is here to stay and will only lead to improved outcomes and greater access to vascular care for our patients for the foreseeable future.
Jihad A. Mustapha, MD, FACC, FSCAI
The data presented were up to date and were very well represented. Discussions about many new technologies to come and ongoing trials made me feel as if there is hope for the future for patients with peripheral artery disease in general.
The focused symposium on “Endovascular Therapy: The Essentials” was a very lively and interactive discussion during which different approaches to therapy were presented. The audience had ample time to ask questions and give input. This is a great approach to learning and one of the many reasons health care providers enjoy attending ISET.
This year’s detailed discussion and presentation on new frontiers of revascularization on end-stage patients with CLI and arteriovenous flow reversal are unique concepts that will help many patients with CLI in the future. Discussion on the DETOUR II trial of the PQ Detour endovascular bypass system (PQ Bypass) also added additional hope for patients that could not otherwise be treated. The transcarotid artery revascularization procedure (Enroute, Silk Road Medical) that was represented was also an eye-opener to me on the value of the technological advances shown at ISET.
I would like to see the continuation of more complex PAD and CLI cases with options on how to get access, cross chronic total occlusions and control the access site. I would also like to see discussion on how to get out of trouble when encountering unexpected situations during cases.
Credit: Pierce Harman
Photography for HMP Global
Constantino S. Peña, MD, FAHA, FSCCT, FSIR
This year, ISET was focused on new technology in the field of endovascular care, as well as other aspects. The townhall on innovation, artificial intelligence and other disruptors was one of many thought-generating sessions that enabled us to assess where the field is going. We looked at AI and the role it may have as well as the potential of artificial blood vessels. This may one day enable us to create our own arteries and custom vessels. There was also a thought-provoking presentation on the future ability to perform catheterizations without fluoroscopy. Putting all that together, there is much to ponder about the future of endovascular therapy.
There were also fantastic presentations on the future role of multimodality imaging and its ability to improve results while reducing procedural time, complexity, radiation and contrast material used. Additionally, the ability to combine endovascular and open surgical techniques to improve patient outcomes was featured. For example, we witnessed this firsthand with a live TCAR case, demonstrating a safer alternative to traditional carotid artery stenting. Another example is the concept of percutaneous bypass surgery. These are young technologies that should be part of our solutions in the future.
Something that makes ISET special is its multispecialty approach. It creates a rich learning environment for attendees. At a lot of meetings, people stay in their own silos. Here, there are excellent interchanges with people from a variety of disciplines. Attendees are able to move forward and learn more because of the different perspectives from different specialties. The live cases are also a valuable part of the experience, and this year’s meeting featured procedures from a wide variety of settings.
Kenneth Rosenfield, MD, MHCDS, FACC, FAHA, MSCAI
There was a great presentation by Ian Del Conde, MD, from Miami Cardiac & Vascular Institute, about how to risk-stratify patients with PE who present acutely, and how to figure out the best treatment. This presentation emphasized the importance of the right ventricle and how its status plays a major role in defining the next steps and in the decision of whether to pursue an aggressive strategy. The RV has a lot less tolerance for overload and strain than the left ventricle.
Another highlight was a debate over the value of PE response teams (PERT). In the end, everyone essentially agreed that having a more team-based and systematic approach to dealing with PE in our hospitals is an advantage. Whether there is a formal multidisciplinary team like a PERT or whether one has a process without a formal team, it is important that patients are dealt with efficiently and effectively and have access to the full range of therapeutic alternatives to ensure they get proper care.
In my presentation, I emphasized that it is not just about treating the acute PE, it is also about how to follow patients in and out of the hospital for at least 1 year afterward. The reality is that almost 50% of patients do not ever get back to normal. The PERT concept emphasizes following these patients in a systematic way to prevent another PE and to ensure we are doing everything we can to return a patient to their normal state. We still have a lot to learn about the best ways to accomplish this. We hope the PERT Consortium’s database can help. We encourage all hospitals to join the consortium and contribute to the database.
There was also much discussion about the recent meta-analysis purporting to link paclitaxel-coated balloons with risk for reduced amputation-free survival in patients with below-the-knee lesions. The bottom line is that there are many methodological challenges with this paper, even more than for the other meta-analyses by this group. I do not see how this new paper adds to anything. The bottom line is, we know the data for the Medtronic DCB (IN.PACT Amphirion) in below-the-knee lesions were not good. The formulation, the way the drug was packaged on the balloon and the conduct of the trial all needed to be revised. That does not mean paclitaxel is bad. It means that this specific product was not ideal. That trial (IN.PACT DEEP) dominated the meta-analysis, and the other trials were compromised in one way or another. I do not see any particular benefit to having published this. Judging from the FDA presentations at this meeting, even the agency recognizes the severe limitations to this meta-analysis. It needs to be taken with a very large grain of salt and we need to move forward to figure out how to use these products in ways that help patients.
To tackle the paclitaxel issue, multiple societies have put together a coalition — the Multi-Specialty Coalition on Paclitaxel — to figure it out as quickly and expeditiously as possible, and if it is proven that there is a real mortality issue, what is its magnitude and how do we apply the information in clinical practice, given that we know about the significant benefits of paclitaxel therapies. It is a matter of risk and benefit, and we need to know more about the risk. This is one of the first efforts I have seen where all the specialties in the vascular arena are working together to collaborate on getting answers to a real issue. The FDA is very excited that we are all together. This framework, plus the RAPID registry, could provide a platform for other multidisciplinary discussions and collaborations. We are all proud to be part of an effort that is taking a high-road approach to this problem. – by Erik Swain
Reference:
Katsanos K, et al. J Vasc Interv Radiol. 2020;doi:10.1016/j.jvir.2019.11.015.
Disclosures: Lookstein reports he consults for Boston Scientific and Medtronic, serves on the speakers bureau for Abbott, Endologix and Medtronic, received research support from Angiodynamics, Bard, Boston Scientific, Penumbra, Philips Healthcare and Veniti and serves on clinical events committees for Intact Vascular, QT Vascular and Shockwave Medical. Mustapha reports he consults for PQ Bypass. Peña reports he consults for Avanos, Cordis and Philips; serves on scientific advisory boards for Boston Scientific, Surmodics and Venture Medical; holds equity in Cagent Medical and Integrity Spine; and is a speaker for Abbott Vascular, BD, Cook Medical, Penumbra and Sirtex. Rosenfield reports he has financial ties with Abbott Vascular, Access Vascular, Angiodynamics, Boston Scientific, BTG, Capture Vascular, Contego, Cruzar Systems, Embolitech, Endospan, Eximo, Janacare, Magneto, MD Insider, Micell, Orchestra, Philips, PQ Bypass, Primacea, Shockwave Medical, Silk Road Medical, Surmodics and the University of Maryland, and is a board member of VIVA Physicians and the PERT Consortium, which are not-for-profit 501(c)3 organizations.