title: Insights from the early experience of the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.
abstract: The current system for postmarket surveillance of medical devices in the United States is limited. To help change this paradigm for transcatheter valve therapies (TVTs), starting with transcatheter aortic valve replacement, the Society of Thoracic Surgeons and the American College of Cardiology partnered to form the TVT Registry program in close collaboration with the U.S. Food and Drug Administration and the Center for Medicare and Medicaid Services. The goal of the TVT Registry is to measure and improve quality of care and patient outcomes in clinical practice and to have a pivotal role in the scientific evidence and surveillance for medical devices. Challenges were faced in the early experience of the registry included developing multistakeholder partnerships, data collection requirements, and the use of the registry for pre- and post-market device evaluations. In addressing these challenges, the TVT Registry demonstrates that it is feasible for professional societies to assume a pivotal role in pre- and/or post-market studies, leveraging a clinical registry infrastructure. Sharing the TVT Registry experience may help other professional societies and stakeholders better anticipate and plan for these challenges.
authors.affiliation: Denver VA Medical Center, Denver, Colorado. Electronic address: john.rumsfeld@va.gov.
authors.forename: John S
authors.initials: JS
authors.lastname: Rumsfeld
authors.affiliation: Division of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota.
authors.forename: David R
authors.initials: DR
authors.lastname: Holmes
authors.affiliation: Campbell University College of Pharmacy and Health Sciences, Buies Creek, North Carolina.
authors.forename: Wendy Gattis
authors.initials: WG
authors.lastname: Stough
authors.affiliation: University of Florida Health Sciences Center, Jacksonville, Florida.
authors.forename: Fred H
authors.initials: FH
authors.lastname: Edwards
authors.affiliation: Centers for Medicare and Medicaid Services, Baltimore, Maryland.
authors.forename: Louis B
authors.initials: LB
authors.lastname: Jacques
authors.affiliation: Baylor Healthcare System, Heart Hospital Baylor, Dallas, Texas.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Mack
mesh_terms: D001021:Aortic Valve / Q000503:physiopathology; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods / Q000592:standards; D006349:Heart Valve Diseases / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods / Q000592:standards; D006439:Hemodynamics; D006801:Humans; D011358:Product Surveillance, Postmarketing / Q000592:standards; D016730:Program Development; D011474:Prosthesis Design; D058996:Quality Improvement; D019984:Quality Indicators, Health Care; D012042:Registries / Q000592:standards; D012955:Societies, Medical; D016896:Treatment Outcome
keywords: Centers for Medicare and Medicaid Services (U.S.); National Cardiovascular Data Registry, registries; U.S. Food and Drug Administration; heart valve prosthesis implantation; investigational device exemption; transcatheter aortic valve replacement