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

被引：87

作者：

Ruiz, Carlos E. ^{[1
]}

Hahn, Rebecca T. ^{[2
,3
]}

Berrebi, Alain ^{[4
]}

Borer, Jeffrey S. ^{[5
,6
]}

Cutlip, Donald E. ^{[7
]}

Fontana, Greg ^{[8
]}

Gerosa, Gino ^{[9
]}

Ibrahim, Reda ^{[10
]}

Jelnin, Vladimir ^{[1
]}

Jilaihawi, Hasan ^{[11
]}

Jolicoeur, E. Marc ^{[10
]}

Kliger, Chad ^{[12
]}

Kronzon, Itzhak ^{[12
]}

Leipsic, Jonathon

Maisano, Francesco ^{[13
,14
]}

Millan, Xavier ^{[15
]}

Nataf, Patrick ^{[16
]}

O'Gara, Patrick T. ^{[17
]}

Pibarot, Philippe ^{[18
]}

Ramee, Stephen R. ^{[19
]}

Rihal, Charanjit S. ^{[20
]}

Rodes-Cabau, Josep ^{[18
]}

Sorajja, Paul ^{[21
,22
]}

Suri, Rakesh ^{[23
]}

Swain, Julie A. ^{[24
]}

Turi, Zoltan G. ^{[25
]}

Tuzcu, E. Murat ^{[23
]}

Weissman, Neil J. ^{[26
]}

Zamorano, Jose L. ^{[27
]}

Serruys, Patrick W. ^{[28
]}

Leon, Martin B. ^{[2
,3
]}

机构：

[1] Hackensack Univ, Med Ctr, Struct & Congenital Heart Ctr, Hackensack, NJ USA

[2] Columbia Univ, Med Ctr, New York, NY USA

[3] Cardiovasc Res Fdn, New York, NY USA

[4] Hop Europeen Georges Pompidou, Paris, France

[5] SUNY, Downstate Med Ctr, New York, NY USA

[6] Coll Med, New York, NY USA

[7] Baim Inst Clin Res, Boston, MA USA

[8] Cedars Sinai Med Ctr, Los Angeles, CA 90048 USA

[9] Padua Univ Hosp, Padua, Italy

[10] Montreal Heart Inst, Montreal, PQ, Canada

[11] NYU, Langone Med Ctr, New York, NY USA

[12] North Shore LIJ Hlth Syst, Lenox Hill Heart & Vasc Inst, New York, NY USA

[13] Univ British Columbia, St Pauls Hosp, Vancouver, BC, Canada

[14] Univ Hosp Zurich, Zurich, Switzerland

[15] Hosp Santa Creu & Sant Pau, Barcelona, Spain

[16] Hop Bichat Claude Bernard, AP HP, Serv Cardiol, Paris, France

[17] Brigham & Womens Hosp, 75 Francis St, Boston, MA 02115 USA

[18] Quebec Heart & Lung Inst, Quebec City, PQ, Canada

[19] Ochsner Clin & Alton Ochsner Med Fdn, New Orleans, LA USA

[20] Mayo Clin, Rochester, MN USA

[21] Minneapolis Heart Inst, Minneapolis, MN USA

[22] Abbott NW Hosp, Minneapolis, MN USA

[23] Cleveland Clin, Cleveland, OH USA

[24] Mt Sinai Sch Med, New York, NY USA

[25] Rutgers Robert Wood Johnson Med Sch, New Brunswick, NJ USA

[26] MedStar Hlth Res Inst, Washington, DC USA

[27] Hosp Clin San Carlos, Madrid, Spain

[28] Imperial Coll London, London, England

来源：

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY | 2017年 / 69卷 / 16期

关键词：

closure devices; regurgitation; transcatheter; AORTIC-VALVE IMPLANTATION; CARDIOVASCULAR MAGNETIC-RESONANCE; VON-WILLEBRAND-FACTOR; 6-MINUTE WALK TEST; QUALITY-OF-LIFE; PERCUTANEOUS REPAIR; HEART-FAILURE; EAE/ASE RECOMMENDATIONS; INFECTIVE ENDOCARDITIS; TRANSCATHETER CLOSURE;

D O I：

10.1016/j.jacc.2017.02.038

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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. (C) 2017 American College of Cardiology Foundation and European Society of Cardiology.

引用

页码：2067 / 2087

页数：21

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