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

21 Citations (Scopus)

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

Fingerprint

Prostheses and Implants
Clinical Trials
Research
Equipment and Supplies
Surgical Instruments
Safety
Transcatheter Aortic Valve Replacement

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., ... 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

Clinical Trial Principles and Endpoint Definitions for Paravalvular Leaks in Surgical Prosthesis : An Expert Statement. / Ruiz, Carlos E.; Hahn, Rebecca T.; Berrebi, Alain; Borer, Jeffrey S.; Cutlip, Donald E.; Fontana, Greg; Gerosa, Gino; Ibrahim, Reda; Jelnin, Vladimir; Jilaihawi, Hasan; Jolicoeur, E. Marc; Kliger, Chad; Kronzon, Itzhak; Leipsic, Jonathon; Maisano, Francesco; Millan, Xavier; Nataf, Patrick; O'Gara, Patrick T.; Pibarot, Philippe; Ramee, Stephen R.; Rihal, Charanjit S.; Rodes-Cabau, Josep; Sorajja, Paul; Suri, Rakesh; Swain, Julie A.; Turi, Zoltan G.; Tuzcu, E. Murat; Weissman, Neil J.; Zamorano, Jose L.; Serruys, Patrick W.; Leon, Martin B.; Paravalvular Leak Academic Research Consortium.

In: Journal of the American College of Cardiology, Vol. 69, No. 16, 25.04.2017, p. 2067-2087.

Research output: Contribution to journalReview article

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 & 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, vol. 69, no. 16, pp. 2067-2087. https://doi.org/10.1016/j.jacc.2017.02.038
Ruiz, Carlos E. ; Hahn, Rebecca T. ; Berrebi, Alain ; Borer, Jeffrey S. ; Cutlip, Donald E. ; Fontana, Greg ; Gerosa, Gino ; Ibrahim, Reda ; Jelnin, Vladimir ; Jilaihawi, Hasan ; Jolicoeur, E. Marc ; Kliger, Chad ; Kronzon, Itzhak ; Leipsic, Jonathon ; Maisano, Francesco ; Millan, Xavier ; Nataf, Patrick ; O'Gara, Patrick T. ; Pibarot, Philippe ; Ramee, Stephen R. ; Rihal, Charanjit S. ; Rodes-Cabau, Josep ; Sorajja, Paul ; Suri, Rakesh ; Swain, Julie A. ; Turi, Zoltan G. ; Tuzcu, E. Murat ; Weissman, Neil J. ; Zamorano, Jose L. ; Serruys, Patrick W. ; Leon, Martin B. ; Paravalvular Leak Academic Research Consortium. / Clinical Trial Principles and Endpoint Definitions for Paravalvular Leaks in Surgical Prosthesis : An Expert Statement. In: Journal of the American College of Cardiology. 2017 ; Vol. 69, No. 16. pp. 2067-2087.
@article{fffa42d1aa804577a0c986f54631a386,
title = "Clinical Trial Principles and Endpoint Definitions for Paravalvular Leaks in Surgical Prosthesis: An Expert Statement",
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.} and {Paravalvular Leak Academic Research Consortium}",
year = "2017",
month = "4",
day = "25",
doi = "10.1016/j.jacc.2017.02.038",
language = "English (US)",
volume = "69",
pages = "2067--2087",
journal = "Journal of the American College of Cardiology",
issn = "0735-1097",
publisher = "Elsevier USA",
number = "16",

}

TY - JOUR

T1 - Clinical Trial Principles and Endpoint Definitions for Paravalvular Leaks in Surgical Prosthesis

T2 - An Expert Statement

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.

AU - Paravalvular Leak Academic Research Consortium

PY - 2017/4/25

Y1 - 2017/4/25

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

UR - http://www.scopus.com/inward/record.url?scp=85018424302&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85018424302&partnerID=8YFLogxK

U2 - 10.1016/j.jacc.2017.02.038

DO - 10.1016/j.jacc.2017.02.038

M3 - Review article

C2 - 28427582

AN - SCOPUS:85018424302

VL - 69

SP - 2067

EP - 2087

JO - Journal of the American College of Cardiology

JF - Journal of the American College of Cardiology

SN - 0735-1097

IS - 16

ER -