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

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.

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Funding Support and Author Disclosures This paper reflects the views of the authors and should not be construed to represent the FDA’s views or policies. Dr Vemulapalli has received grants from or has contracts with the American College of Cardiology, The Society of Thoracic Surgeons, the National Institutes of Health (R01 and Small Business Innovation Research), the FDA (National Evaluation System for Health Technology collaborative community), Abbott, Boston Scientific, and Cytokinetics; and is an advisory board member or consultant for Janssen, HeartFlow, Boston Scientific, and the American College of Physicians. Dr Krucoff has received grants from, has contracts with, or is a consultant for Abbott Vascular, Boston Scientific, Medtronic, Mitre Medical, and OrbusNeich. Dr Alu has received institutional research funding from Abbott and Edwards Lifesciences. Dr Leon has received institutional grants for clinical research from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.