Clinical Trial Design Principles and Endpoint Definitions for Transcatheter Mitral Valve Repair and Replacement: Part 1: Clinical Trial Design Principles A Consensus Document From the Mitral Valve Academic Research Consortium

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

卷:66

Article

Stone, Gregg W.^1,2  Vahanian, Alec S.³  Adams, David H.⁴  Abraham, William T.⁵  Borer, Jeffrey S.⁶  Bax, Jeroen J.⁷  Schofer, Joachim⁸  Cutlip, Donald E.⁹  Krucoff, Mitchell W.¹⁰  Blackstone, Eugene H.¹¹  Genereux, Philippe^1,2,12  Mack, Michael J.¹³  Siegel, Robert J.¹⁴  Grayburn, Paul A.¹³  Enriquez-Sarano, Maurice¹⁵  Lancellotti, Patrizio¹⁶  Filippatos, Gerasimos¹⁷  Kappetein, Arie Pieter¹⁸ 

[1] Columbia Univ, New York Presbyterian Hosp, Med Ctr, New York, NY 10022 USA

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

[3] Hop Bichat Claude Bernard, F-75877 Paris, France

[4] Mt Sinai Hlth Syst, New York, NY USA

[5] Ohio State Univ, Columbus, OH 43210 USA

[6] Suny Downstate Med Ctr, Brooklyn, NY 11203 USA

[7] Leiden Univ, Med Ctr, Leiden, Netherlands

[8] Univ Hamburg, Ctr Cardiovasc, Hamburg, Germany

[9] Beth Israel Deaconess Med Ctr, Boston, MA 02215 USA

[10] Duke Univ, Med Ctr, Durham, NC USA

[11] Cleveland Clin, Cleveland, OH 44106 USA

[12] Hop Sacre Coeur, Montreal, PQ H4J 1C5, Canada

[13] Baylor Univ, Med Ctr, Dallas, TX USA

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

[15] Mayo Clin, Rochester, MN USA

[16] Univ Hosp Liege, Liege, Belgium

[17] Univ Athens, Hosp Attikon, Athens, Greece

[18] Erasmus Univ, Med Ctr, Rotterdam, Netherlands

关键词: heart failure;    mitral regurgitation;    mitral valve;    valve intervention;    valve surgery (or cardiac surgery);   

DOI  :  10.1016/j.jacc.2015.05.046

来源: Elsevier

【 摘 要 】

Mitral regurgitation (MR) is one of the most prevalent valve disorders and has numerous etiologies, including primary (organic) MR, due to underlying degenerative/structural mitral valve (MV) pathology, and secondary (functional) MR, which is principally caused by global or regional left ventricular remodeling and/or severe left atrial dilation. Diagnosis and optimal management of MR requires integration of valve disease and heart failure specialists, MV cardiac surgeons, interventional cardiologists with expertise in structural heart disease, and imaging experts. The introduction of transcatheter MV therapies has highlighted the need for a consensus approach to pragmatic clinical trial design and uniform endpoint definitions to evaluate outcomes in patients with MR. The Mitral Valve Academic Research Consortium is a collaboration between leading academic research organizations and physician-scientists specializing in MV disease from the United States and Europe. Three in-person meetings were held in Virginia and New York during which 44 heart failure, valve, and imaging experts, MV surgeons and interventional cardiologists, clinical trial specialists and statisticians, and representatives from the U.S. Food and Drug Administration considered all aspects of MV pathophysiology, prognosis, and therapies, culminating in a 2-part document describing consensus recommendations for clinical trial design (Part 1) and endpoint definitions (Part 2) to guide evaluation of transcatheter and surgical therapies for MR. The adoption of these recommendations will afford robustness and consistency in the comparative effectiveness evaluation of new devices and approaches to treat MR. These principles may be useful for regulatory assessment of new transcatheter MV devices, as well as for monitoring local and regional outcomes to guide quality improvement initiatives. (C) 2015 by the American College of Cardiology Foundation.

【 授权许可】

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