The Present and Future
Clinical Statement
Clinical Trial Design Principles and Endpoint Definitions for Transcatheter Mitral Valve Repair and Replacement: Part 2: Endpoint Definitions: A Consensus Document From the Mitral Valve Academic Research Consortium

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Abstract

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.

Key Words

heart failure
mitral regurgitation
mitral valve
valve intervention
valve surgery (or cardiac surgery)

Abbreviations and Acronyms

LV
left ventricular
MI
myocardial infarction
MR
mitral regurgitation
MV
mitral valve
MVARC
Mitral Valve Academic Research Consortium

Cited by (0)

For complete information on the MVARC members and participants, please see the Online Appendix. The MVARC initiative was funded by unrestricted grant support from Abbott Vascular, Boston Scientific, Cardiac Dimensions, Cordis, Edwards Lifesciences, Guided Delivery Systems Inc., Mitralign, Medtronic, Valtech. Dr. Stone has served as a consultant for AGA Medical, AstraZeneca, Atrium, Boston Scientific, Cardiovascular Systems, Inc., Eli Lilly/Daiichi Sankyo partnership, InfraReDx, InspireMD, Miracor, Osprey, Reva, TherOx, Thoratec, Velomedix, and Volcano; and has equity in the Biostar and MedFocus family of funds, Caliber, Guided Delivery Systems, MiCardia, and Vascular Nanotransfer Technologies. Dr. Adams has received royalties for intellectual property paid to his medical institution from Edwards Lifesciences and Medtronic. Dr. Abraham has served as a consultant for Abbott Vascular, Novartis, and St. Jude Medical/CardioMEMS. Dr. Généreux has received grants from Cardiac Dimensions, Inc.; and serves as a consultant/speaker for Abbott Vascular, Cardiovascular Systems, Inc., and Edwards Lifesciences. Dr. Mehran has received grants from AstraZeneca, Bristol-Myers Squibb/Sanofi-Aventis, Lilly/Daiichi Sankyo, and The Medicines Company; serves as a consultant for Abbott Vascular, AstraZeneca, Boston Scientific, Covidien, CSL Behring, Janssen (Johnson & Johnson), Maya Medical, Merck, and Regado Biosciences; and serves as an advisory board member for Covidien, Endothelix, Inc., Janssen, Merck, and Sanofi. Dr. Kuck has received grants and personal fees from Biosense Webster, Medtronic, and St. Jude Medical. Dr. Piazza has served as a consultant for Medtronic; has received grants from Medtronic and St. Jude Medical; and has equity in CardiAQ and Highlife. Dr. Head has received personal fees for lectures and product development from Medtronic. Dr. Filippatos has received grants from Abbott Vascular; and serves as a committee member or principal investigator of trials sponsored by Bayer, Cardiorentis, the European Union, Medtronic, and Novartis. Dr. Vahanian has received personal fees from and served as a consultant for Abbott Vascular, Edwards Lifesciences, and Valtech. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Saibal Kar, MD, served as Guest Editor for this paper.

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