Clinical Trial Principles and Endpoint Definitions for Paravalvular Leaks in Surgical Prosthesis

Carlos E. Ruiz; Rebecca T. Hahn; Alain Berrebi; Jeffrey S. Borer; Donald E. Cutlip; Greg Fontana; Gino Gerosa; Reda Ibrahim; Vladimir Jelnin; Hasan Jilaihawi; E. Marc Jolicoeur; Chad Kliger; Itzhak Kronzon; Jonathon Leipsic; Francesco Maisano; Xavier Millan; Patrick Nataf; Patrick T. O'Gara; Philippe Pibarot; Stephen R. Ramee; Charanjit S. Rihal; Josep Rodes-Cabau; Paul Sorajja; Rakesh Suri; Julie A. Swain; Zoltan G. Turi; E. Murat Tuzcu; Neil J. Weissman; Jose L. Zamorano; Patrick W. Serruys; Martin B. Leon

doi:10.1093/eurheartj/ehx211

Clinical Trial Principles and Endpoint Definitions for Paravalvular Leaks in Surgical Prosthesis

Carlos E. Ruiz, Rebecca T. Hahn, Alain Berrebi, Jeffrey S. Borer, Donald E. Cutlip, Greg Fontana, Gino Gerosa, Reda Ibrahim, Vladimir Jelnin, Hasan Jilaihawi, E. Marc Jolicoeur, Chad Kliger, Itzhak Kronzon, Jonathon Leipsic, Francesco Maisano, Xavier Millan, Patrick Nataf, Patrick T. O'Gara, Philippe Pibarot, Stephen R. RameeCharanjit S. Rihal, Josep Rodes-Cabau, Paul Sorajja, Rakesh Suri, Julie A. Swain, Zoltan G. Turi, E. Murat Tuzcu, Neil J. Weissman, Jose L. Zamorano, Patrick W. Serruys, Martin B. Leon

Cardiovascular Medicine

Research output: Contribution to journal › Review article › peer-review

14 Scopus citations

Abstract

The VARC (Valve Academic Research Consortium) for transcatheter aortic valve replacement set the standard for selecting appropriate clinical endpoints reflecting safety and effectiveness of transcatheter devices, and defining single and composite clinical endpoints for clinical trials. No such standardization exists for circumferentially sutured surgical valve paravalvular leak (PVL) closure. This document seeks to provide core principles, appropriate clinical endpoints, and endpoint definitions to be used in clinical trials of PVL closure devices. The PVL Academic Research Consortium met to review evidence and make recommendations for assessment of disease severity, data collection, and updated endpoint definitions. A 5-class grading scheme to evaluate PVL was developed in concordance with VARC recommendations. Unresolved issues in the field are outlined. The current PVL Academic Research Consortium provides recommendations for assessment of disease severity, data collection, and endpoint definitions. Future research in the field is warranted.

Original language	English (US)
Pages (from-to)	1224-1245
Number of pages	22
Journal	European heart journal
Volume	39
Issue number	15
DOIs	https://doi.org/10.1093/eurheartj/ehx211
State	Published - Apr 14 2018

Keywords

closure devices
regurgitation
transcatheter

ASJC Scopus subject areas

Cardiology and Cardiovascular Medicine

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10.1093/eurheartj/ehx211

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Ruiz, C. E., Hahn, R. T., Berrebi, A., Borer, J. S., Cutlip, D. E., Fontana, G., Gerosa, G., Ibrahim, R., Jelnin, V., Jilaihawi, H., Jolicoeur, E. M., Kliger, C., Kronzon, I., Leipsic, J., Maisano, F., Millan, X., Nataf, P., O'Gara, P. T., Pibarot, P., ... Leon, M. B. (2018). Clinical Trial Principles and Endpoint Definitions for Paravalvular Leaks in Surgical Prosthesis. European heart journal, 39(15), 1224-1245. https://doi.org/10.1093/eurheartj/ehx211

Ruiz, CE, Hahn, RT, Berrebi, A, Borer, JS, Cutlip, DE, Fontana, G, Gerosa, G, Ibrahim, R, Jelnin, V, Jilaihawi, H, Jolicoeur, EM, Kliger, C, Kronzon, I, Leipsic, J, Maisano, F, Millan, X, Nataf, P, O'Gara, PT, Pibarot, P, Ramee, SR, Rihal, CS, Rodes-Cabau, J, Sorajja, P, Suri, R, Swain, JA, Turi, ZG, Tuzcu, EM, Weissman, NJ, Zamorano, JL, Serruys, PW & Leon, MB 2018, 'Clinical Trial Principles and Endpoint Definitions for Paravalvular Leaks in Surgical Prosthesis', European heart journal, vol. 39, no. 15, pp. 1224-1245. https://doi.org/10.1093/eurheartj/ehx211

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title = "Clinical Trial Principles and Endpoint Definitions for Paravalvular Leaks in Surgical Prosthesis",

abstract = "The VARC (Valve Academic Research Consortium) for transcatheter aortic valve replacement set the standard for selecting appropriate clinical endpoints reflecting safety and effectiveness of transcatheter devices, and defining single and composite clinical endpoints for clinical trials. No such standardization exists for circumferentially sutured surgical valve paravalvular leak (PVL) closure. This document seeks to provide core principles, appropriate clinical endpoints, and endpoint definitions to be used in clinical trials of PVL closure devices. The PVL Academic Research Consortium met to review evidence and make recommendations for assessment of disease severity, data collection, and updated endpoint definitions. A 5-class grading scheme to evaluate PVL was developed in concordance with VARC recommendations. Unresolved issues in the field are outlined. The current PVL Academic Research Consortium provides recommendations for assessment of disease severity, data collection, and endpoint definitions. Future research in the field is warranted.",

keywords = "closure devices, regurgitation, transcatheter",

author = "Ruiz, {Carlos E.} and Hahn, {Rebecca T.} and Alain Berrebi and Borer, {Jeffrey S.} and Cutlip, {Donald E.} and Greg Fontana and Gino Gerosa and Reda Ibrahim and Vladimir Jelnin and Hasan Jilaihawi and Jolicoeur, {E. Marc} and Chad Kliger and Itzhak Kronzon and Jonathon Leipsic and Francesco Maisano and Xavier Millan and Patrick Nataf and O'Gara, {Patrick T.} and Philippe Pibarot and Ramee, {Stephen R.} and Rihal, {Charanjit S.} and Josep Rodes-Cabau and Paul Sorajja and Rakesh Suri and Swain, {Julie A.} and Turi, {Zoltan G.} and Tuzcu, {E. Murat} and Weissman, {Neil J.} and Zamorano, {Jose L.} and Serruys, {Patrick W.} and Leon, {Martin B.}",

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AU - Ruiz, Carlos E.

AU - Hahn, Rebecca T.

AU - Berrebi, Alain

AU - Borer, Jeffrey S.

AU - Cutlip, Donald E.

AU - Fontana, Greg

AU - Gerosa, Gino

AU - Ibrahim, Reda

AU - Jelnin, Vladimir

AU - Jilaihawi, Hasan

AU - Jolicoeur, E. Marc

AU - Kliger, Chad

AU - Kronzon, Itzhak

AU - Leipsic, Jonathon

AU - Maisano, Francesco

AU - Millan, Xavier

AU - Nataf, Patrick

AU - O'Gara, Patrick T.

AU - Pibarot, Philippe

AU - Ramee, Stephen R.

AU - Rihal, Charanjit S.

AU - Rodes-Cabau, Josep

AU - Sorajja, Paul

AU - Suri, Rakesh

AU - Swain, Julie A.

AU - Turi, Zoltan G.

AU - Tuzcu, E. Murat

AU - Weissman, Neil J.

AU - Zamorano, Jose L.

AU - Serruys, Patrick W.

AU - Leon, Martin B.

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N2 - The VARC (Valve Academic Research Consortium) for transcatheter aortic valve replacement set the standard for selecting appropriate clinical endpoints reflecting safety and effectiveness of transcatheter devices, and defining single and composite clinical endpoints for clinical trials. No such standardization exists for circumferentially sutured surgical valve paravalvular leak (PVL) closure. This document seeks to provide core principles, appropriate clinical endpoints, and endpoint definitions to be used in clinical trials of PVL closure devices. The PVL Academic Research Consortium met to review evidence and make recommendations for assessment of disease severity, data collection, and updated endpoint definitions. A 5-class grading scheme to evaluate PVL was developed in concordance with VARC recommendations. Unresolved issues in the field are outlined. The current PVL Academic Research Consortium provides recommendations for assessment of disease severity, data collection, and endpoint definitions. Future research in the field is warranted.

AB - The VARC (Valve Academic Research Consortium) for transcatheter aortic valve replacement set the standard for selecting appropriate clinical endpoints reflecting safety and effectiveness of transcatheter devices, and defining single and composite clinical endpoints for clinical trials. No such standardization exists for circumferentially sutured surgical valve paravalvular leak (PVL) closure. This document seeks to provide core principles, appropriate clinical endpoints, and endpoint definitions to be used in clinical trials of PVL closure devices. The PVL Academic Research Consortium met to review evidence and make recommendations for assessment of disease severity, data collection, and updated endpoint definitions. A 5-class grading scheme to evaluate PVL was developed in concordance with VARC recommendations. Unresolved issues in the field are outlined. The current PVL Academic Research Consortium provides recommendations for assessment of disease severity, data collection, and endpoint definitions. Future research in the field is warranted.

KW - closure devices

KW - regurgitation

KW - transcatheter

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Clinical Trial Principles and Endpoint Definitions for Paravalvular Leaks in Surgical Prosthesis

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