1. Minimum Core Data Elements for Transcatheter Mitral Therapies: Scientific Statement by PASSION CV, HVC, and TVTR.
- Author
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Vemulapalli S, Simonato M, Ben Yehuda O, Wu C, Feldman T, Popma JJ, Sundareswaren K, Krohn C, Hardy KM, Guibone K, Christensen B, Alu MC, Ng VG, Chau KH, Chen S, Shahim B, Vincent F, MacMahon J, James S, Mack M, Leon MB, Thourani VH, Carroll J, and Krucoff MW
- Subjects
- Aged, Humans, United States, Treatment Outcome, Catheters, Centers for Medicare and Medicaid Services, U.S., Multicenter Studies as Topic, Medicare, Cardiology
- 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., Competing Interests: Funding Support and Author Disclosures Dr Vemulapalli has received grants/contracts from the American College of Cardiology, Society of Thoracic Surgeons, National Institutes of Health (R01 and SBIR), Food and Drug Administration (NEST cc), Abbott, Boston Scientific, and Cytokinetics; and is on the advisory board or is a consultant for Edwards Lifesciences, Medtronic, American College of Physicians, and Total CME. Ms Alu has received institutional research funding from Abbott and Edwards Lifesciences. Dr Shahim has received a research grant from the Stockholm county research council. Dr James has been a proctor for Medtronic. Dr Leon has received institutional grants for clinical research from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Thourani has been an advisor for Abbott Vascular, ARtivion, Atricure, Boston Scientific, Edwards Lifesciences, Medtronic, and Shockwave. Dr Carroll has received institutional grants for clinical trials from Edwards Lifesciences, Medtronic, and Abbott; and has been a consultant for Abbott. Dr Krucoff has received grants from Abbott Vascular, Boston Scientific, Medtronic, Mitre Medical, OrbusNeich, and 4C Medical; and has been a consultant for Abbott Vascular, Boston Scientific, Medtronic, Mitre Medical, OrbusNeich, and 4C Medical., (Copyright © 2023 American College of Cardiology Foundation. All rights reserved.)
- Published
- 2023
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