Clinical Trial Principles and Endpoint Definitions for Paravalvular Leaks in Surgical Prosthesis: An Expert Statement

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, Paravalvular Leak Academic Research Consortium

Research output: Contribution to journalReview article

26 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 languageEnglish (US)
Pages (from-to)2067-2087
Number of pages21
JournalJournal of the American College of Cardiology
Volume69
Issue number16
DOIs
StatePublished - Apr 25 2017

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Keywords

  • closure devices
  • regurgitation
  • transcatheter

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

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., ... Paravalvular Leak Academic Research Consortium (2017). Clinical Trial Principles and Endpoint Definitions for Paravalvular Leaks in Surgical Prosthesis: An Expert Statement. Journal of the American College of Cardiology, 69(16), 2067-2087. https://doi.org/10.1016/j.jacc.2017.02.038