Date of download: 6/28/2016 Copyright © The American College of Cardiology. All rights reserved. From: The STS-ACC Transcatheter Valve Therapy National Registry: A New Partnership and Infrastructure for the Introduction and Surveillance of Medical Devices and Therapies J Am Coll Cardiol. 2013;62(11): doi: /j.jacc TVT Registry Is Placed in Context of Process of Device Evaluation Leading to and After FDA Approval The dotted vertical line represents the time when Food and Drug Administration (FDA) approval occurs. Previous clinical registries run by professional societies have been developed to monitor results of established procedures. The transcatheter valve therapy (TVT) registry will prospectively capture patients immediately after device approval. There are plans to potentially expand the TVT registry into the pre-PMA period to further bring data element standardization and efficient transitions from the pre-approval to post-approval phases of device evaluation. PMA = premarket approval; RCT = randomized clinical trial. Figure Legend:

Date of download: 6/28/2016 Copyright © The American College of Cardiology. All rights reserved. From: The STS-ACC Transcatheter Valve Therapy National Registry: A New Partnership and Infrastructure for the Introduction and Surveillance of Medical Devices and Therapies J Am Coll Cardiol. 2013;62(11): doi: /j.jacc Cumulative TVT Registry Sites Enrolled From January 2012 to Beginning August 2013 The graph depicts the number of hospitals enrolled in the transcatheter valve therapy (TVT) registry during 2012 plus mid 2013 and represents nearly all active transcatheter aortic valve replacement sites in the United States. The process of enrollment can take some time for hospitals to complete, and the few remaining sites are expected to complete the process soon. ACC = American College of Cardiology; NCDR = National Cardiovascular Data Registry; STS = The Society of Thoracic Surgeons. Figure Legend:

Date of download: 6/28/2016 Copyright © The American College of Cardiology. All rights reserved. From: The STS-ACC Transcatheter Valve Therapy National Registry: A New Partnership and Infrastructure for the Introduction and Surveillance of Medical Devices and Therapies J Am Coll Cardiol. 2013;62(11): doi: /j.jacc Cumulative TVT Records May 2012 to Beginning August 2013 Patients who have undergone transcatheter aortic valve replacement and have had their data entered into the transcatheter valve therapy (TVT) registry during 2012 plus mid 2013 are plotted as a function of month of data submission for their procedure. Acceleration of entries occurred after the national coverage decision from the Center for Medicare and Medicaid Services announced the reimbursement requirements that included registry participation. Sites are still entering their backlog of completed cases. As of August 7, 2013 there were 8,108 patient records entered. Abbreviations as in Figure 2. Figure Legend: