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Minimum Core Data Elements for Evaluation of TAVR : A Scientific Statement by PASSION CV, HVC, and TVT Registry

Authors :
Simonato, Matheus
Vemulapalli, Sreekanth
Ben-Yehuda, Ori
Wu, Changfu
Wood, Larry
Popma, Jeff
Feldman, Ted
Krohn, Carole
Hardy, Karen M.
Guibone, Kimberly
Christensen, Barbara
Alu, Maria C.
Chen, Shmuel
Ng, Vivian G.
Chau, Katherine H.
Shahim, Bahira
Vincent, Flavien
MacMahon, John
James, Stefan
Mack, Michael
Leon, Martin B.
Thourani, Vinod H.
Carroll, John
Krucoff, Mitchell
Simonato, Matheus
Vemulapalli, Sreekanth
Ben-Yehuda, Ori
Wu, Changfu
Wood, Larry
Popma, Jeff
Feldman, Ted
Krohn, Carole
Hardy, Karen M.
Guibone, Kimberly
Christensen, Barbara
Alu, Maria C.
Chen, Shmuel
Ng, Vivian G.
Chau, Katherine H.
Shahim, Bahira
Vincent, Flavien
MacMahon, John
James, Stefan
Mack, Michael
Leon, Martin B.
Thourani, Vinod H.
Carroll, John
Krucoff, Mitchell
Publication Year :
2022

Abstract

Transcatheter aortic valve replacement (TAVR) is the standard of care for severe, symptomatic aortic stenosis. Real-world TAVR data collection contributes to benefit/risk assessment and safety evidence for the U.S. Food and Drug Administration, quality evaluation for the Centers for Medicare and Medicaid Services and hospitals, as well as clinical research and real-world implementation through appropriate use criteria. The essential minimum core dataset for these purposes has not previously been defined but is necessary to promote efficient, reusable real-world data collection supporting quality, regulatory, and clinical applications. The authors performed a systematic review of the published research for high-impact TAVR studies and U.S. multicenter, multidevice registries. Two expert task forces, one from the Predictable and Sustainable Implementation of National Cardiovascular Registries/Heart Valve Collaboratory and another from The Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry convened separately and then met to reconcile a final list of essential data elements. From 276 unique data elements considered, unanimous consensus agreement was achieved on 132 "core" data elements, with the most common reasons for exclusion from the minimum core dataset being burden or difficulty in accurate assessment (36.9%), duplicative information (33.3%), and low likelihood of affecting outcomes (10.7%). After a systematic review and extensive discussions, a multilateral group of academicians, industry representatives, and regulators established 132 interoperable, reusable essential core data elements essential to supporting more efficient, consistent, and informative TAVR device evidence for regulatory submissions, safety surveillance, best practice, and hospital quality assessments.

Details

Database :
OAIster
Notes :
application/pdf, English
Publication Type :
Electronic Resource
Accession number :
edsoai.on1349083109
Document Type :
Electronic Resource
Full Text :
https://doi.org/10.1016.j.athoracsur.2022.01.018