The Take Home

The Take Home: ISET

The International Symposium on Endovascular Therapy (ISET) was held Jan. 27 to 30 in Hollywood, Florida, and Cardiology Today’s Intervention covered it live. The conference offered up a number of hot topics in endovascular intervention, some of which are highlighted by George Adams, MD, from the University of North Carolina Chapel Hill Medical Center and UNC Rex Healthcare; William A. Gray, MD, from Main Line Health and Lankenau Heart Institute in Wynnewood, Pennsylvania; Barry T. Katzen, MD, from Miami Cardiac and Vascular Institute at Baptist Health South Florida; Jihad A. Mustapha, MD, from Michigan State University College of Osteopathic Medicine and Advanced Cardiac and Vascular Amputation Prevention Centers in Grand Rapids, Michigan; and Cardiology Today’s Intervention Editorial Board Member Kenneth Rosenfield, MD, MHCDS, from Massachusetts General Hospital.

George Adams

George Adams, MD

One important theme that emerged from ISET was biologic therapies. Specifically, the recent paper by Konstantinos Katsanos, MD, PhD, MSc, EBIR, assistant professor of interventional radiology at Patras University Hospital in Rion, Greece, and colleagues showing that there was a signal that paclitaxel-coated devices may confer a mortality risk when used in patients with peripheral artery disease prompted a session devoted to the topic. Presenters delineated patient-level data from studies of three drug-coated balloons and two drug-eluting stents showing that there was no increased mortality risk compared to plain old balloon angioplasty, as Katsanos and colleagues implied in their paper.

Also of note, Gary M. Ansel, MD, FACC, system medical chief for vascular at OhioHealth in Columbus and a Cardiology Today’s Intervention Editorial Board Member, gave a great presentation on fiscal responsibility and the current cost to health care and its trends. The take-home message is that with increasing costs, health care providers, industry and health care administrators are trying to work together to try to develop solutions to keep costs down and provide the most effective treatments. Otherwise, what will happen is that regulators will make these choices for us, and ultimately the patients may not have the devices which are warranted to treat PAD.

William A. Gray, MD

William A. Gray

A highlight was a robust and deep dive into the issues around the recent meta-analysis that suggested there might be a mortality effect related to the use of paclitaxel with drug-eluting technologies in the lower extremities. We had an expert panel and presentations that included a deep dive into the pharmacology of paclitaxel; its therapeutic dose ranging; the limited amount of paclitaxel that is still present in tissue and plasma after implantation or use of these devices according to robust pharmacokinetic studies; and then a summary of some of the patient-level data which are now available from some of the individual sponsors, which helps us understand better some of the issues that were raised in the meta-analysis. On balance, there did not appear to be a signal with DCB or DES paclitaxel usage in the lower extremities and long-term mortality. But ultimately, that will be determined by an amalgamation of these patient-level data by the FDA and the VIVA Vascular Leaders Forum and other entities. As is well-known, mortality is not a frequent event in these patients, and therefore these trials are not typically powered for mortality as an endpoint. It’s usually part of a composite endpoint. It usually takes several thousand patients to understand any real impact on mortality. In addition to that, we believe there will be other sources of data, like Medicare registries. Of note, however, is that Circulation published a correction that 5-year mortality was higher in patients treated with a paclitaxel-eluting stent (Zilver PTX, Cook Medical) vs. those treated with percutaneous transluminal angioplasty, not lower as previously reported.

We were also treated to an excellent Tegtmeyer Lecture by Jeffrey W. Olin, DO, professor of medicine at the Icahn School of Medicine at Mount Sinai. He gave us a spectacular lecture on fibromuscular dysplasia, which he’s been an enlightened expert on and has driven much of the therapeutic and diagnostic understanding of this disease. The lecture covered not only the presentation in the peripheral arterial system, but also the association of fibromuscular dysplasia with spontaneous coronary artery dissection.

Barry T. Katzen

Barry T. Katzen, MD

A couple of topics of great interest were presented first at ISET. One was on the use of stem cells to reduce restenosis in arteriovenous fistulas. This was presented by Sanjay Misra, MD, FAHA, FSIR, professor of radiology at Mayo Clinic, and involved first-in-man implantation in surgically implanted arteriovenous fistulas after a certain amount of animal work. This presentation was also presented in a poster, which won the Best Poster Award. We also saw first-time demonstration of a device that may lead to catheterization without the need for fluoroscopy or for X-ray via the ability to determine a catheter in space by a new technology (Fiber Optic RealShape, Philips). This is a unique device, and I shared first-in-man experience on behalf of Joost van Herwaarden, MD, vascular surgeon at University Medical Center Utrecht, Netherlands.

There was also a lot of discussion about critical limb ischemia, which is an epidemic around the world. There were presentations on how to best treat that, how to detect it, how to prevent it and the role of medical therapy. Two out-of-the-box medical treatments for CLI and claudication were presented. One was the use of overhydration. Juan Carlos Parodi, MD, chief of surgery at Trinidad Hospital, University of Buenos Aires, presented his experience with high oral intake of fluids to alleviate symptoms of claudication. And Gervacio A. Lamas, MD, chairman of medicine and chief of the Columbia University Division of Cardiology at Mount Sinai Medical Center in Miami Beach, Florida, presented signal findings from a pilot study using chelation therapy to heal wounds in patients with CLI who failed endovascular or surgical therapy, the so-called “no-option patients.” These represented exciting, less invasive approaches to treating CLI.

Jihad A. Mustapha

Jihad A. Mustapha, MD, FACC, FSCAI

ISET was an exciting meeting, full of new trials, technologies, tips, tricks and techniques.

At ISET we were able to discuss some of the latest controversies in an extremely professional way and were able to come to some sort of common ground in those discussions. We looked at the latest technologies and therapies for CLI, which is a very serious and deadly disease.

In addition, there were townhalls in which we discussed various topics about disease in the vascular system. We listened to the perspectives of national and international key opinion leaders and combined their ideas together leading to a consensus approach on difficult unique topics such as whether it is better to treat the common femoral artery surgically or endovascularly. It was nice to see a multidisciplinary team discussing such topics in a calm fashion and have their perspective presented and accepted by both parties. Another extremely interesting townhall was on distal tibial or pedal bypass vs. endovascular revascularization.

ISET has taken us to the next level of education. It represents the modern world of education, where multiple specialties can discuss their different approaches to therapy and embrace the others’ perspectives.

Kenneth Rosenfield, MD, MHCDS

The most interesting session I went to was the one on pulmonary embolism, which is what I would call an international crisis, with a large number of patients that actually die from it, and yet it is an area where there is a huge gap in our knowledge base. Many of us are trying to fill that gap, including the leadership of ISET and the Pulmonary Embolism Response Team (PERT) Consortium, an initiative I helped create; there are now more than 125 PERT programs.

Kenneth Rosenfield

John Moriarty, MD, director of the program for interventional innovation and co-director of vascular ultrasound service at UCLA, talked about clot extraction and the new devices that are available for us. How do we find a place for those devices? What is their relative role? This is something we hope PERT programs and the PERT Consortium can help define.

Keith M. Sterling, MD, FSIR, chief of the department of cardiovascular and interventional radiology at Inova Alexandria Hospital and associate professor of radiology at George Washington University School of Medicine, spoke about thrombolytic therapy and the role of thrombolysis: catheter-directed with EKOS catheters and ultrasonic facilitation, and also systemic thrombolysis. When do you use each of these therapies? These are all areas of controversy and areas where we need to improve our decision-making. This is related to the whole issue of PERT programs and a multidisciplinary approach to decision-making and coming to a consensus about what the best treatment is for a given patient.

Disclosures: Adams reports he is a consultant for Boston Scientific, Cook Medical, C.R. Bard, Medtronic and Philips. Gray reports he is a consultant for Abbott Vascular, Boston Scientific, Medtronic, Surmodics and W.L. Gore and Associates. Katzen reports he is a consultant for Philips Healthcare and serves on advisory boards for Boston Scientific, Graftworks, Hemodynamics and W.L. Gore and Associates. Mustapha reports he has financial ties with 480 Biomedical, BD/Bard, Bioendothelium, Boston Scientific, Cagent Vascular, Cardio Flow, Cardiovascular Systems Inc., Medtronic, Micromedical Solutions, Philips, PQ Bypass, Reflow Medical and Terumo. Rosenfield reports he has financial ties with numerous drug and device companies.

The International Symposium on Endovascular Therapy (ISET) was held Jan. 27 to 30 in Hollywood, Florida, and Cardiology Today’s Intervention covered it live. The conference offered up a number of hot topics in endovascular intervention, some of which are highlighted by George Adams, MD, from the University of North Carolina Chapel Hill Medical Center and UNC Rex Healthcare; William A. Gray, MD, from Main Line Health and Lankenau Heart Institute in Wynnewood, Pennsylvania; Barry T. Katzen, MD, from Miami Cardiac and Vascular Institute at Baptist Health South Florida; Jihad A. Mustapha, MD, from Michigan State University College of Osteopathic Medicine and Advanced Cardiac and Vascular Amputation Prevention Centers in Grand Rapids, Michigan; and Cardiology Today’s Intervention Editorial Board Member Kenneth Rosenfield, MD, MHCDS, from Massachusetts General Hospital.

George Adams

George Adams, MD

One important theme that emerged from ISET was biologic therapies. Specifically, the recent paper by Konstantinos Katsanos, MD, PhD, MSc, EBIR, assistant professor of interventional radiology at Patras University Hospital in Rion, Greece, and colleagues showing that there was a signal that paclitaxel-coated devices may confer a mortality risk when used in patients with peripheral artery disease prompted a session devoted to the topic. Presenters delineated patient-level data from studies of three drug-coated balloons and two drug-eluting stents showing that there was no increased mortality risk compared to plain old balloon angioplasty, as Katsanos and colleagues implied in their paper.

Also of note, Gary M. Ansel, MD, FACC, system medical chief for vascular at OhioHealth in Columbus and a Cardiology Today’s Intervention Editorial Board Member, gave a great presentation on fiscal responsibility and the current cost to health care and its trends. The take-home message is that with increasing costs, health care providers, industry and health care administrators are trying to work together to try to develop solutions to keep costs down and provide the most effective treatments. Otherwise, what will happen is that regulators will make these choices for us, and ultimately the patients may not have the devices which are warranted to treat PAD.

William A. Gray, MD

William A. Gray

A highlight was a robust and deep dive into the issues around the recent meta-analysis that suggested there might be a mortality effect related to the use of paclitaxel with drug-eluting technologies in the lower extremities. We had an expert panel and presentations that included a deep dive into the pharmacology of paclitaxel; its therapeutic dose ranging; the limited amount of paclitaxel that is still present in tissue and plasma after implantation or use of these devices according to robust pharmacokinetic studies; and then a summary of some of the patient-level data which are now available from some of the individual sponsors, which helps us understand better some of the issues that were raised in the meta-analysis. On balance, there did not appear to be a signal with DCB or DES paclitaxel usage in the lower extremities and long-term mortality. But ultimately, that will be determined by an amalgamation of these patient-level data by the FDA and the VIVA Vascular Leaders Forum and other entities. As is well-known, mortality is not a frequent event in these patients, and therefore these trials are not typically powered for mortality as an endpoint. It’s usually part of a composite endpoint. It usually takes several thousand patients to understand any real impact on mortality. In addition to that, we believe there will be other sources of data, like Medicare registries. Of note, however, is that Circulation published a correction that 5-year mortality was higher in patients treated with a paclitaxel-eluting stent (Zilver PTX, Cook Medical) vs. those treated with percutaneous transluminal angioplasty, not lower as previously reported.

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We were also treated to an excellent Tegtmeyer Lecture by Jeffrey W. Olin, DO, professor of medicine at the Icahn School of Medicine at Mount Sinai. He gave us a spectacular lecture on fibromuscular dysplasia, which he’s been an enlightened expert on and has driven much of the therapeutic and diagnostic understanding of this disease. The lecture covered not only the presentation in the peripheral arterial system, but also the association of fibromuscular dysplasia with spontaneous coronary artery dissection.

Barry T. Katzen

Barry T. Katzen, MD

A couple of topics of great interest were presented first at ISET. One was on the use of stem cells to reduce restenosis in arteriovenous fistulas. This was presented by Sanjay Misra, MD, FAHA, FSIR, professor of radiology at Mayo Clinic, and involved first-in-man implantation in surgically implanted arteriovenous fistulas after a certain amount of animal work. This presentation was also presented in a poster, which won the Best Poster Award. We also saw first-time demonstration of a device that may lead to catheterization without the need for fluoroscopy or for X-ray via the ability to determine a catheter in space by a new technology (Fiber Optic RealShape, Philips). This is a unique device, and I shared first-in-man experience on behalf of Joost van Herwaarden, MD, vascular surgeon at University Medical Center Utrecht, Netherlands.

There was also a lot of discussion about critical limb ischemia, which is an epidemic around the world. There were presentations on how to best treat that, how to detect it, how to prevent it and the role of medical therapy. Two out-of-the-box medical treatments for CLI and claudication were presented. One was the use of overhydration. Juan Carlos Parodi, MD, chief of surgery at Trinidad Hospital, University of Buenos Aires, presented his experience with high oral intake of fluids to alleviate symptoms of claudication. And Gervacio A. Lamas, MD, chairman of medicine and chief of the Columbia University Division of Cardiology at Mount Sinai Medical Center in Miami Beach, Florida, presented signal findings from a pilot study using chelation therapy to heal wounds in patients with CLI who failed endovascular or surgical therapy, the so-called “no-option patients.” These represented exciting, less invasive approaches to treating CLI.

Jihad A. Mustapha

Jihad A. Mustapha, MD, FACC, FSCAI

ISET was an exciting meeting, full of new trials, technologies, tips, tricks and techniques.

At ISET we were able to discuss some of the latest controversies in an extremely professional way and were able to come to some sort of common ground in those discussions. We looked at the latest technologies and therapies for CLI, which is a very serious and deadly disease.

PAGE BREAK

In addition, there were townhalls in which we discussed various topics about disease in the vascular system. We listened to the perspectives of national and international key opinion leaders and combined their ideas together leading to a consensus approach on difficult unique topics such as whether it is better to treat the common femoral artery surgically or endovascularly. It was nice to see a multidisciplinary team discussing such topics in a calm fashion and have their perspective presented and accepted by both parties. Another extremely interesting townhall was on distal tibial or pedal bypass vs. endovascular revascularization.

ISET has taken us to the next level of education. It represents the modern world of education, where multiple specialties can discuss their different approaches to therapy and embrace the others’ perspectives.

Kenneth Rosenfield, MD, MHCDS

The most interesting session I went to was the one on pulmonary embolism, which is what I would call an international crisis, with a large number of patients that actually die from it, and yet it is an area where there is a huge gap in our knowledge base. Many of us are trying to fill that gap, including the leadership of ISET and the Pulmonary Embolism Response Team (PERT) Consortium, an initiative I helped create; there are now more than 125 PERT programs.

Kenneth Rosenfield

John Moriarty, MD, director of the program for interventional innovation and co-director of vascular ultrasound service at UCLA, talked about clot extraction and the new devices that are available for us. How do we find a place for those devices? What is their relative role? This is something we hope PERT programs and the PERT Consortium can help define.

Keith M. Sterling, MD, FSIR, chief of the department of cardiovascular and interventional radiology at Inova Alexandria Hospital and associate professor of radiology at George Washington University School of Medicine, spoke about thrombolytic therapy and the role of thrombolysis: catheter-directed with EKOS catheters and ultrasonic facilitation, and also systemic thrombolysis. When do you use each of these therapies? These are all areas of controversy and areas where we need to improve our decision-making. This is related to the whole issue of PERT programs and a multidisciplinary approach to decision-making and coming to a consensus about what the best treatment is for a given patient.

Disclosures: Adams reports he is a consultant for Boston Scientific, Cook Medical, C.R. Bard, Medtronic and Philips. Gray reports he is a consultant for Abbott Vascular, Boston Scientific, Medtronic, Surmodics and W.L. Gore and Associates. Katzen reports he is a consultant for Philips Healthcare and serves on advisory boards for Boston Scientific, Graftworks, Hemodynamics and W.L. Gore and Associates. Mustapha reports he has financial ties with 480 Biomedical, BD/Bard, Bioendothelium, Boston Scientific, Cagent Vascular, Cardio Flow, Cardiovascular Systems Inc., Medtronic, Micromedical Solutions, Philips, PQ Bypass, Reflow Medical and Terumo. Rosenfield reports he has financial ties with numerous drug and device companies.

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