TY - JOUR
T1 - Insights from the early experience of the society of thoracic surgeons/American college of cardiology transcatheter valve therapy registry
AU - Rumsfeld, John S.
AU - Holmes, David R.
AU - Stough, Wendy Gattis
AU - Edwards, Fred H.
AU - Jacques, Louis B.
AU - Mack, Michael J.
N1 - Publisher Copyright:
© 2015 American College of Cardiology Foundation.
PY - 2015/3/1
Y1 - 2015/3/1
N2 - 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.
AB - 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.
KW - Centers for Medicare and Medicaid Services (U.S.)
KW - National Cardiovascular Data Registry
KW - U.S. Food and Drug Administration
KW - heart valve prosthesis implantation
KW - investigational device exemption
KW - registries
KW - transcatheter aortic valve replacement
UR - http://www.scopus.com/inward/record.url?scp=84926415787&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84926415787&partnerID=8YFLogxK
U2 - 10.1016/j.jcin.2014.09.022
DO - 10.1016/j.jcin.2014.09.022
M3 - Review article
C2 - 25703888
AN - SCOPUS:84926415787
SN - 1936-8798
VL - 8
SP - 377
EP - 381
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 3
ER -