title: Transcatheter valve therapy registry is a model for medical device innovation and surveillance.
abstract: Heart valve diseases are increasingly prevalent, especially in people older than age seventy. Many of these elderly people have other comorbid conditions, making them poor candidates for surgical treatment of heart valve diseases. Since 2011 such patients have been eligible to receive new nonsurgical heart valve treatments approved by the Food and Drug Administration (FDA) and covered by Medicare. This article examines the Transcatheter Valve Therapy Registry, which captures clinical information on all US patients undergoing new nonsurgical heart valve treatments. The registry has patient-level data from more than 27,000 patients treated with the novel devices. Patient- and procedure-related data are gathered from hospitals, patient-reported outcomes are assessed pre- and postprocedure, and longer-term data on mortality and repeat hospitalization are provided by linking the registry's data to Medicare patient data. The registry is a model of collaboration among professional societies, the FDA, the Centers for Medicare and Medicaid Services, hospitals, patients, and the medical device industry. It has been used to support Medicare coverage decisions, expand device indications, provide comprehensive device surveillance, and establish national quality benchmarks. Beyond having it serve as a collaborative model, future goals for the registry include shortening the FDA-approval timeline for devices, providing data for decision-making tools for patients, and public reporting of hospital performance.
authors: John D. Carroll (john.carroll@ucdenver.edu) is a professor of medicine at the University of Colorado School of Medicine, in Aurora.
authors: John D
authors: JD
authors: Carroll
authors: Jeff Shuren is director of the Center for Devices and Radiological Health at the Food and Drug Administration, in Silver Spring, Maryland.
authors: Jeff
authors: J
authors: Shuren
authors: Tamara Syrek Jensen is director of the Coverage and Analysis Group at the Center for Clinical Standards and Quality, Centers for Medicare and Medicaid Services, in Baltimore, Maryland.
authors: Tamara Syrek
authors: TS
authors: Jensen
authors: John Hernandez is divisional vice president of Health Economics and Outcomes Research at Abbott Vascular, in Santa Clara, California.
authors: John
authors: J
authors: Hernandez
authors: David Holmes is a professor of medicine at the Mayo Clinic College of Medicine, in Rochester, Minnesota.
authors: David
authors: D
authors: Holmes
authors: Danica Marinac-Dabic is director of the Division of Epidemiology, Center for Devices and Radiological Health, Food and Drug Administration.
authors: Danica
authors: D
authors: Marinac-Dabic
authors: Fred H. Edwards is Emeritus Professor at the University of Florida, in Jacksonville.
authors: Fred H
authors: FH
authors: Edwards
authors: Bram D. Zuckerman is director of the Division of Cardiovascular Devices, Center for Devices and Radiological Health, Food and Drug Administration.
authors: Bram D
authors: BD
authors: Zuckerman
authors: Larry L. Wood is corporate vice president of Edwards Lifesciences Corporation, in Irvine, California.
authors: Larry L
authors: LL
authors: Wood
authors: Richard E. Kuntz is senior vice president and chief scientific, clinical, and regulatory officer at Medtronic, in Minneapolis, Minnesota.
authors: Richard E
authors: RE
authors: Kuntz
authors: Michael J. Mack is a cardiothoracic surgeon at Baylor Scott & White Health, in Plano, Texas.
authors: Michael J
authors: MJ
authors: Mack
mesh_terms: D006349:Heart Valve Diseases / Q000601:surgery*; D006801:Humans; D000070516:Intersectoral Collaboration; D017146:Models, Organizational; D011358:Product Surveillance, Postmarketing / Q000379:methods / Q000592:standards*; D012042:Registries; D013673:Technology Assessment, Biomedical / Q000379:methods* / Q000458:organization & administration / Q000706:statistics & numerical data; D065467:Transcatheter Aortic Valve Replacement / Q000379:methods* / Q000592:standards / Q000706:statistics & numerical data; D014481:United States
keywords: Epidemiology; Evidence-Based Medicine; Legal/Regulatory Issues; Medicine/Clinical Issues; Quality Of Care