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PREVAIL Study of Boston Scientific's Watchman Published

July 8, 2014—In the Journal of the American College of Cardiology, David R. Holmes, MD, et al published the findings from the PREVAIL trial, a prospective, randomized evaluation of the Watchman left atrial appendage closure device (Boston Scientific Corporation) in patients with atrial fibrillation versus long-term warfarin therapy (2014;64:1–16).

Annual Outcomes From the STS/ACC TVT Registry Evaluate Transcatheter Valve Therapy

November 30, 2015—David R. Holmes, Jr, MD, et al published a report of the annual outcomes of transcatheter valve therapy (TVT) from the Society of Thoracic Surgeons/American College of Cardiology (STS/ACC) TVT Registry, which is available online ahead of print in Annals of Thoracic Surgery and Journal of the American College of Cardiology.

STS/ACC TVT Registry Shows Real-World TAVR Results Are Consistent With Clinical Trials

March 31, 2014—David R. Holmes, MD, presented 1-year outcomes from the Society of Thoracic Surgery/American College of Cardiology (STS/ACC) Transcatheter Valve Therapy (TVT) Registry at the ACC.14: 63rd annual scientific session of the American College of Cardiology being held in Washington, DC. The US National TVT Registry is a collaboration of the STS, ACC, Centers for Medicare and Medicaid Services, and the US Food and Drug Administration.

ACC and STS Issue Expert Consensus Document on Transcatheter Valve Therapy

June 27, 2011—The American College of Cardiology (ACC) and the Society of Thoracic Surgeons (STS) have published an expert consensus document on transcatheter valve therapy.

Long-Term Data Reported From Continued Access Registries of Boston Scientific's Watchman LAAC Device

December 2, 2019—Findings from continued access registries on the long-term safety and efficacy of the Watchman left atrial appendage closure (LAAC) device (Boston Scientific Corporation) for stroke prevention in patients with nonvalvular atrial registries were published by David R. Holmes Jr, MD, et al in Journal of the American College of Cardiology (JACC; 2019;74:2878–2889). The investigators sought to evaluate 4.5- to 5-year data in two FDA-mandated registries for safety and efficacy of LAAC with the Watchman device: CAP (Continued Access to PROTECT-AF) and CAP2 (Continued Access to PREVAIL).

Multisociety Consensus Document Offers Guidance for TAVR

January 31, 2012—A multisociety expert consensus document from the American College of Cardiology Foundation (ACCF), the American Association for Thoracic Surgery (AATS), the Society for Cardiovascular Angiography and Interventions (SCAI), and the Society of Thoracic Surgeons (STS) was published to provide guidance on the use of transcatheter aortic valve replacement (TAVR) to treat patients with aortic valvular stenosis.

CMS Initiates National Coverage Analysis of TAVR

September 29, 2011—The US Centers for Medicare & Medicaid Services (CMS) has initiated a National Coverage Analysis (NCA) of transcatheter aortic valve replacement (TAVR). CMS stated that it received a formal national coverage determination (NCD) request from the Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC). According to CMS, STS and ACC advised the agency that clinical trial data shows that the most successful patient outcomes occur when the following criteria are met: the procedure is performed in a specialized heart center and managed using a multidisciplinary team in which each member has appropriate training and credentials (requirements are currently under development for this); the procedure is performed in a modified conventional cardiac laboratory or hybrid operating room that contains the specialized equipment necessary for the procedure; and the multidisciplinary team uses a planned approach to co-manage decision making as well as technical insertion of the device.

STS/ACC Launch Registry for Transcatheter Valve Therapy

December 1, 2011—The Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC) announced the launch of the first-of-its-kind registry to monitor the safety and efficacy of transcathether aortic valve replacement therapy (TAVR), which was approved by the US Food and Drug Administration (FDA) in November 2011 for elderly patients with aortic stenosis who are too sick, frail, or high risk for surgical therapy.