A New Model for Device Innovation and Surveillance

Journal Wrap | The STS/ACC TVT Registry is a model for collaboration among professional societies and is a model for medical device innovation and surveillance since it “facilitates and accelerates the learning process during the introduction of revolutionary new treatments for heart valve abnormalities,” according to a study published Feb. 2 in Health Affairs.

The study, included as part of Health Affairs’ thematic issue on biomedical innovations, was led by John Carroll, MD, member of the TVT Registry Steering Committee. Carroll and colleagues describe the history of heart valve treatment development, the regulatory process for U.S. market approval of devices, how the TVT Registry was developed and all that it has accomplished since its launch in December 2011.

They note that the Registry now has more than 27,000 patient records representing all U.S. patients undergoing new nonsurgical heart valve treatments, with transcatheter aortic valve replacement now available in 354 U.S. hospitals, and transcatheter mitral valve repair now available in 100 U.S. hospitals. With the patient- and procedural-related data that is gathered, “patient-reported outcomes are assessed pre-and post-procedure, and long-term data on mortality and repeat hospitalization are provided by linking the Registry’s data to Medicare patient data.”

Further, the Registry has been able to “support Medicare coverage decisions, expand device indications, provide comprehensive device surveillance, and establish national quality benchmarks.”

The authors note that, moving forward, future goals of the registry include “shortening the U.S. Food and Drug Administration (FDA) approval timeline for devices, providing data for decision-making tools for patients, and public reporting of hospital performance.”

“We are pleased to have the structure, accomplishments and future goals of the STS/ACC TVT Registry published in this highly influential journal in the health policy field,” said Carroll. “My coauthors include others representing the ACC and the Society of Thoracic Surgeons as well as leaders from the FDA, the Centers for Medicare and Medicaid Services, and the medical device industry who are all engaged in this collaboration to improve care of patients, the performance of hospitals, and the effectiveness of our national system for medical device regulation and surveillance.”

Carroll J, Shuren J, Jensen TS, et al. Health Affairs. 2015;34:328-34.

Keywords: CardioSource WorldNews Interventions

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