The Take Home

Take Home: ISET

Cardiology Today’s Intervention was onsite in Hollywood, Florida, from Feb. 4-8, 2017, in attendance at the 29th Annual International Symposium on Endovascular Therapy. Several experts discussed their most important takeaways from the meeting, including William A. Gray, MD, from Main Line Health, Wynnewood, Pennsylvania; Cardiology Today’s Intervention Editorial Board member Michael R. Jaff, DO, FSCAI, from Newton-Wellesley Hospital in Newton, Massachusetts, and Harvard Medical School; Barry T. Katzen, MD, FSIR, from Miami Cardiac and Vascular Institute and Florida International University; John Moriarty, MD, from UCLA; and Victor Tapson, MD, FCCP, FRCP, from Cedars-Sinai.

CLI TOWN HALL MEETING
Barry T. Katzen

Katzen: One particularly noteworthy session was the Town Hall meeting on critical limb ischemia. At many meetings, CLI sessions focus on techniques and technologies and how certain lesions should be treated. However, this informative and engaging session at ISET 2017 was driven toward the specific purpose of increasing awareness of and dealing with the public health issues surrounding CLI. We identified challenges that clinicians face, including how to build CLI programs without having a definable diagnosis-related group or any specific codes by which quality outcomes and costs can be measured. We also identified opportunities to improve patient care, such as gaining a greater understanding of the actual cost of CLI.

During this session, I also took the opportunity to announce the formation of the Critical Limb Ischemia Global Society, which has been organized specifically to reduce amputation rates and mortality in patients with CLI. It is a nonprofit organization designed to address issues on the regulatory and reimbursement fronts as well as on the educational front.

Michael R. Jaff

Jaff: The opening Town Hall session on CLI was important. It was a very broad discussion that not only dealt with the magnitude of this terrible disease on our patients, the outcomes, the options for therapy and advances, but it also had an extensive discussion on how to build a team for limb salvage, the successful components of a team and how to know whether you’ve been successful — is it just preventing amputation or is it about having a functional outcome that matters? We also talked a lot about cost and price. The session ended with a discussion of the BEST-CLI trial, sponsored by the NIH: How it’s enrolling, what are the opportunities to increase enrollment and what will we learn from that trial.

Gray: The CLI Town Hall was a recognition and a tip of the hat to an emerging field which has gathered a lot of interest, but for which there’s still a paucity of data and a paucity of tool sets which are approved in the United States. We discussed the issues surrounding the difficulty with device testing, the challenges in endpoints such as CLI with amputation-free survival — should we just be focusing on patency — and some of the dropout rates we have in patients with CLI. We know that in many of the trials that have been done to date, we have a one-in-four chance of losing a patient for a variety of different reasons, including death at the 1-year mark. On top of all the other issues with this population, this makes it challenging to do trials.

Also, given the lack of data and a real need out there, we talked about what we should be doing, ranging from the choice of devices to the choice of patients to wound care, which is increasingly becoming an important component of CLI treatment.

On the nonclinical side of CLI, there was a discussion of cost, which has not been well described because the care takes place over a spectrum of places like the hospital, skilled nursing facilities and wound care centers. The combined costs of this disability are not insignificant. We were very honest and complete about the 360° view of CLI.

Photo credit: Cardiology Today’s Intervention

CAROTID STENTING
William A. Gray

Gray: The carotid stenting section attracted world-class experts, ranging from Thomas G. Brott, MD, principal investigator of the CREST-2 trial, to Frank J. Veith, MD, who is a lion in this field. A general consensus emerged on several topics. No. 1, there have been two large major trials published in reputable journals showing equivalence between carotid stenting and carotid endarterectomy, but with the acknowledgement that there is a minor excess in minor strokes in carotid stenting. This is a target for improvement in carotid stent outcomes. A possible solution is patient selection, and that was discussed at length.

Also discussed were issues around proximal protection and direct carotid access, including double filtration protection with a balloon attached to a filter which is deployed temporarily during post-deployment balloon inflation. We also talked about the newer mesh-covered stents, some of which already have data. Taken in sum, this suggests that we are on the verge of another wave of improved outcomes in carotid stenting because we see these as combined therapies, which can reduce the rates of complication and stroke outcomes. We touched on the fact that there are correlating data in diffusion-weighted MRI abnormalities that also show reduction in those findings with advancing technologies.

Lastly, like in CLI, we acknowledged that there is a financial and economic issue to be addressed. I think there was broad agreement that it would be reasonable for CMS to reconsider their coverage decision for carotid stenting given that there are now two very well done, very large trials published in journals that have shown equivalency between the two therapies, and that patient choice here should be primary.

Jaff: The discussion about carotid stenting was great. It seems there is a gradually increasing renewed enthusiasm around this field. Even some of the most stalwart opponents of carotid stenting have started to say that the future for it looks brighter. Of course, reimbursement challenges remain for carotid stenting procedures in the standard, asymptomatic, non-high-risk patients with high-grade carotid disease. There were also some great discussions about CREST-2, which may prove to be the definitive study of carotid stenting, including how enrollment is going and what the future of that trial looks like.

VTE ADVANCES

Tapson: A lot of interesting things are going on in the venous thromboembolism world nowadays, often involving invasive therapy or catheter-directed therapy. In the VTE sessions at ISET 2017, we tried to sort out which kinds of patients can benefit from this kind of therapy.

Victor Tapson

A big theme over recent years has been risk-stratification of patients. We see patients with pulmonary embolism who are either low risk, intermediate risk or high risk. Low risk means your right ventricle is normal and your therapy will be anticoagulation, which has been proven to decrease mortality. The intermediate-risk patients are a little trickier, because they are a heterogenous group. The European Society of Cardiology VTE guidelines have emphasized the use of the simplified Pulmonary Embolism Severity Index (sPESI) score to risk-stratify these patients. If the score is 0, that would signal low risk, unless the right ventricle is also abnormal. If any one of the following factors are present — age 80 years or older, cardiopulmonary disease or cancer, heart rate > 110 bpm, systolic BP < 100 mm Hg or oxygen saturation < 90% — the sPESI score is 1 and that signals intermediate risk.

There was a lot of discussion about what to do with intermediate-risk patients. The ESC has further divided them into intermediate-low risk, ie, RV is abnormal on echocardiogram or a biomarker (troponin or type B natriuretic peptide) is elevated. Intermediate-high risk is defined as both an abnormal RV by echo and an abnormal biomarker. Maybe those are patients that we should be more aggressive with. These intermediate-risk patients are the most controversial. Several clinical trials are either underway or finishing up, including OPTALYSE PE, assessing catheter-based lysis with the EkoSonic Endovascular System (EKOS Corp.); FLARE, evaluating a clot extraction device (FlowTriever, Inari Medical); and a study of an inhibitor of the activated form of thrombin-activatable fibrinolysis inhibitor (DS-1040, Daiichi Sankyo). Hopefully more answers will come.

Patients with massive PE are also a heterogenous group, but easier to make decisions on. Once we see hypotension from acute PE, mortality clearly goes up and we should consider systemic thrombolysis or perhaps a catheter-based treatment in those patients.

Moriarty:The venous and PE sessions at ISET 2017 displayed something we are seeing increasingly at all meetings, whether interventional radiology, pulmonology or cardiology: the move toward a multidisciplinary team approach. This is certainly something that has been at the forefront of people’s minds for a while, but really has been put into action over the last short time.

John Moriarty

Regardless of the vascular condition, we have learned that working in a team seems to not only give you a good working environment, but also to give the best outcome to the patient, which is, of course, the most important thing. For my own practice, I always come away from ISET with something new, something that I have either been doing for years that could be done better, or most importantly, something that I haven’t been doing at all that I really should be doing. That was certainly the case here again this year.

Disclosure: Gray reports consulting for Boston Scientific, Cook Medical, Intact Vascular, Medtronic, Shockwave Medical, St. Jude Medical and W.L. Gore and Associates; performing contracted research for Boston Scientific, Intact Vascular and W.L. Gore and Associates; and holding equity in Biomedia, Conteso Medical and Silk Road Medical. Jaff reports serving on advisory boards for the American Orthotics/Prosthetics Association, Miceli, Primacea, Valiant Medical and Volcano/Philips; holding equity in Embolitech, Janacare, MC10, Northwind Medical, PQ Bypass, Primacea, Sano V and Vascular Therapeutics; being founder of Primacea; and serving as a non-compensated advisor for Abbott Vascular, Boston Scientific, Cordis and Medtronic. Katzen reports financial ties with Boston Scientific, Philips Healthcare and W.L. Gore and Associates. Moriarty reports receiving research funding from AngioDynamics, Argon Medical and Penumbra Medical. Tapson reports consulting for AngioDynamics, Bayer, EKOS/BTG, Inari, Janssen and Portola; receiving research funding from Bayer, BiO2 Medical, Daiichi Sankyo, EKOS/BTG, Inari, Janssen and Portola; and speaking for EKOS/BTG and Janssen.

Cardiology Today’s Intervention was onsite in Hollywood, Florida, from Feb. 4-8, 2017, in attendance at the 29th Annual International Symposium on Endovascular Therapy. Several experts discussed their most important takeaways from the meeting, including William A. Gray, MD, from Main Line Health, Wynnewood, Pennsylvania; Cardiology Today’s Intervention Editorial Board member Michael R. Jaff, DO, FSCAI, from Newton-Wellesley Hospital in Newton, Massachusetts, and Harvard Medical School; Barry T. Katzen, MD, FSIR, from Miami Cardiac and Vascular Institute and Florida International University; John Moriarty, MD, from UCLA; and Victor Tapson, MD, FCCP, FRCP, from Cedars-Sinai.

CLI TOWN HALL MEETING
Barry T. Katzen

Katzen: One particularly noteworthy session was the Town Hall meeting on critical limb ischemia. At many meetings, CLI sessions focus on techniques and technologies and how certain lesions should be treated. However, this informative and engaging session at ISET 2017 was driven toward the specific purpose of increasing awareness of and dealing with the public health issues surrounding CLI. We identified challenges that clinicians face, including how to build CLI programs without having a definable diagnosis-related group or any specific codes by which quality outcomes and costs can be measured. We also identified opportunities to improve patient care, such as gaining a greater understanding of the actual cost of CLI.

During this session, I also took the opportunity to announce the formation of the Critical Limb Ischemia Global Society, which has been organized specifically to reduce amputation rates and mortality in patients with CLI. It is a nonprofit organization designed to address issues on the regulatory and reimbursement fronts as well as on the educational front.

Michael R. Jaff

Jaff: The opening Town Hall session on CLI was important. It was a very broad discussion that not only dealt with the magnitude of this terrible disease on our patients, the outcomes, the options for therapy and advances, but it also had an extensive discussion on how to build a team for limb salvage, the successful components of a team and how to know whether you’ve been successful — is it just preventing amputation or is it about having a functional outcome that matters? We also talked a lot about cost and price. The session ended with a discussion of the BEST-CLI trial, sponsored by the NIH: How it’s enrolling, what are the opportunities to increase enrollment and what will we learn from that trial.

Gray: The CLI Town Hall was a recognition and a tip of the hat to an emerging field which has gathered a lot of interest, but for which there’s still a paucity of data and a paucity of tool sets which are approved in the United States. We discussed the issues surrounding the difficulty with device testing, the challenges in endpoints such as CLI with amputation-free survival — should we just be focusing on patency — and some of the dropout rates we have in patients with CLI. We know that in many of the trials that have been done to date, we have a one-in-four chance of losing a patient for a variety of different reasons, including death at the 1-year mark. On top of all the other issues with this population, this makes it challenging to do trials.

Also, given the lack of data and a real need out there, we talked about what we should be doing, ranging from the choice of devices to the choice of patients to wound care, which is increasingly becoming an important component of CLI treatment.

On the nonclinical side of CLI, there was a discussion of cost, which has not been well described because the care takes place over a spectrum of places like the hospital, skilled nursing facilities and wound care centers. The combined costs of this disability are not insignificant. We were very honest and complete about the 360° view of CLI.

Photo credit: Cardiology Today’s Intervention

CAROTID STENTING
William A. Gray

Gray: The carotid stenting section attracted world-class experts, ranging from Thomas G. Brott, MD, principal investigator of the CREST-2 trial, to Frank J. Veith, MD, who is a lion in this field. A general consensus emerged on several topics. No. 1, there have been two large major trials published in reputable journals showing equivalence between carotid stenting and carotid endarterectomy, but with the acknowledgement that there is a minor excess in minor strokes in carotid stenting. This is a target for improvement in carotid stent outcomes. A possible solution is patient selection, and that was discussed at length.

Also discussed were issues around proximal protection and direct carotid access, including double filtration protection with a balloon attached to a filter which is deployed temporarily during post-deployment balloon inflation. We also talked about the newer mesh-covered stents, some of which already have data. Taken in sum, this suggests that we are on the verge of another wave of improved outcomes in carotid stenting because we see these as combined therapies, which can reduce the rates of complication and stroke outcomes. We touched on the fact that there are correlating data in diffusion-weighted MRI abnormalities that also show reduction in those findings with advancing technologies.

PAGE BREAK

Lastly, like in CLI, we acknowledged that there is a financial and economic issue to be addressed. I think there was broad agreement that it would be reasonable for CMS to reconsider their coverage decision for carotid stenting given that there are now two very well done, very large trials published in journals that have shown equivalency between the two therapies, and that patient choice here should be primary.

Jaff: The discussion about carotid stenting was great. It seems there is a gradually increasing renewed enthusiasm around this field. Even some of the most stalwart opponents of carotid stenting have started to say that the future for it looks brighter. Of course, reimbursement challenges remain for carotid stenting procedures in the standard, asymptomatic, non-high-risk patients with high-grade carotid disease. There were also some great discussions about CREST-2, which may prove to be the definitive study of carotid stenting, including how enrollment is going and what the future of that trial looks like.

VTE ADVANCES

Tapson: A lot of interesting things are going on in the venous thromboembolism world nowadays, often involving invasive therapy or catheter-directed therapy. In the VTE sessions at ISET 2017, we tried to sort out which kinds of patients can benefit from this kind of therapy.

Victor Tapson

A big theme over recent years has been risk-stratification of patients. We see patients with pulmonary embolism who are either low risk, intermediate risk or high risk. Low risk means your right ventricle is normal and your therapy will be anticoagulation, which has been proven to decrease mortality. The intermediate-risk patients are a little trickier, because they are a heterogenous group. The European Society of Cardiology VTE guidelines have emphasized the use of the simplified Pulmonary Embolism Severity Index (sPESI) score to risk-stratify these patients. If the score is 0, that would signal low risk, unless the right ventricle is also abnormal. If any one of the following factors are present — age 80 years or older, cardiopulmonary disease or cancer, heart rate > 110 bpm, systolic BP < 100 mm Hg or oxygen saturation < 90% — the sPESI score is 1 and that signals intermediate risk.

There was a lot of discussion about what to do with intermediate-risk patients. The ESC has further divided them into intermediate-low risk, ie, RV is abnormal on echocardiogram or a biomarker (troponin or type B natriuretic peptide) is elevated. Intermediate-high risk is defined as both an abnormal RV by echo and an abnormal biomarker. Maybe those are patients that we should be more aggressive with. These intermediate-risk patients are the most controversial. Several clinical trials are either underway or finishing up, including OPTALYSE PE, assessing catheter-based lysis with the EkoSonic Endovascular System (EKOS Corp.); FLARE, evaluating a clot extraction device (FlowTriever, Inari Medical); and a study of an inhibitor of the activated form of thrombin-activatable fibrinolysis inhibitor (DS-1040, Daiichi Sankyo). Hopefully more answers will come.

Patients with massive PE are also a heterogenous group, but easier to make decisions on. Once we see hypotension from acute PE, mortality clearly goes up and we should consider systemic thrombolysis or perhaps a catheter-based treatment in those patients.

Moriarty:The venous and PE sessions at ISET 2017 displayed something we are seeing increasingly at all meetings, whether interventional radiology, pulmonology or cardiology: the move toward a multidisciplinary team approach. This is certainly something that has been at the forefront of people’s minds for a while, but really has been put into action over the last short time.

John Moriarty

Regardless of the vascular condition, we have learned that working in a team seems to not only give you a good working environment, but also to give the best outcome to the patient, which is, of course, the most important thing. For my own practice, I always come away from ISET with something new, something that I have either been doing for years that could be done better, or most importantly, something that I haven’t been doing at all that I really should be doing. That was certainly the case here again this year.

Disclosure: Gray reports consulting for Boston Scientific, Cook Medical, Intact Vascular, Medtronic, Shockwave Medical, St. Jude Medical and W.L. Gore and Associates; performing contracted research for Boston Scientific, Intact Vascular and W.L. Gore and Associates; and holding equity in Biomedia, Conteso Medical and Silk Road Medical. Jaff reports serving on advisory boards for the American Orthotics/Prosthetics Association, Miceli, Primacea, Valiant Medical and Volcano/Philips; holding equity in Embolitech, Janacare, MC10, Northwind Medical, PQ Bypass, Primacea, Sano V and Vascular Therapeutics; being founder of Primacea; and serving as a non-compensated advisor for Abbott Vascular, Boston Scientific, Cordis and Medtronic. Katzen reports financial ties with Boston Scientific, Philips Healthcare and W.L. Gore and Associates. Moriarty reports receiving research funding from AngioDynamics, Argon Medical and Penumbra Medical. Tapson reports consulting for AngioDynamics, Bayer, EKOS/BTG, Inari, Janssen and Portola; receiving research funding from Bayer, BiO2 Medical, Daiichi Sankyo, EKOS/BTG, Inari, Janssen and Portola; and speaking for EKOS/BTG and Janssen.