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Minimum Core Data Elements for Transcatheter Mitral Therapies: Scientific Statement by PASSION CV, HVC, and TVTR.

Authors :
Vemulapalli, Sreekanth
Simonato, Matheus
Ben Yehuda, Ori
Wu, Changfu
Feldman, Ted
Popma, Jeffrey J.
Sundareswaren, Kartik
Krohn, Carole
Hardy, Karen M.
Guibone, Kimberly
Christensen, Barbara
Alu, Maria C.
Ng, Vivian G.
Chau, Katherine H.
Chen, Shmuel
Shahim, Bahira
Vincent, Flavien
MacMahon, John
James, Stefan
Mack, Michael
Source :
JACC: Cardiovascular Interventions; Jun2023, Vol. 16 Issue 12, p1437-1447, 11p
Publication Year :
2023

Abstract

Mitral regurgitation is the most common valvular disease and is estimated to affect over 5 million Americans. Real-world data collection contributes to safety and effectiveness evidence for the U.S. Food and Drug Administration, quality evaluation for the Centers for Medicare and Medicaid Services and hospitals, and clinical best practice research. We aimed to establish a minimum core data set in mitral interventions to promote efficient, reusable real-world data collection for all of these purposes. Two expert task forces separately evaluated and reconciled a list of candidate elements derived from: 1) 2 ongoing transcatheter mitral trials; and 2) a systemic literature review of high-impact mitral trials and U.S multicenter, multidevice registries. From 703 unique data elements considered, unanimous consensus agreement was achieved on 127 "core" data elements, with the most common reasons for exclusion from the minimum core data set being burden or difficulty in accurate assessment (41.2%), duplicative information (25.0%), and low likelihood of affecting outcomes (19.6%). After a systematic review and extensive discussions, a multilateral group of academicians, industry representatives, and regulators established and implemented into the national Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapies Registry 127 interoperable, reusable core data elements to support more efficient, consistent, and informative transcatheter mitral device evidence for regulatory submissions, safety surveillance, best practice development, and hospital quality assessments. [Display omitted] • Minimum core data elements have not been established for the field of transcatheter mitral valve therapies. • A collaboration of the PASSION-CV, Heart Valve Collaboratory, and STS/ACC TVT Registry has established a set of 127 core data elements based on an extensive systematic review and expert consensus. • Instantiation of core data elements in premarket and postmarket studies of transcatheter mitral interventions will promote consistency, efficiency and quality of data supporting evidence development for quality, regulatory, and clinical applications. [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
19368798
Volume :
16
Issue :
12
Database :
Supplemental Index
Journal :
JACC: Cardiovascular Interventions
Publication Type :
Academic Journal
Accession number :
164400772
Full Text :
https://doi.org/10.1016/j.jcin.2023.03.034