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.

According to the societies, the Transcatheter Valve Therapy (TVT) Registry was jointly developed by STS/ACC to track real-world outcomes related to TAVR. The registry is the result of an ongoing collaboration between the two societies in support of TAVR introduction in the United States. It was also developed in collaboration with the FDA and the US Centers for Medicare & Medicaid (CMS), with input from the Society for Cardiovascular Angiography and Intervention and the American Association for Thoracic Surgery.

According to the societies, the TVT Registry is backed by the expertise of the STS National Database and the ACC's National Cardiovascular Data Registry (NCDR). It serves as the main repository for all clinical data related to TAVR and will incorporate additional catheter-based procedures that have yet to come to market in the United States. The TVT Registry will also be linked to the Social Security Death Master File and CMS databases to track long-term outcomes. The registry will be subject to data quality checks and audits.

To facilitate accurate and reliable data collection, STS and ACC will sponsor several educational opportunities and events for data managers, including webinars and conference calls. Participating hospitals will receive quarterly reports comparing an institution's procedure performance with that of the national experience. The registry measures will also look at patient risk factors to adjust for case-mix and adverse event rates. More information is available on the TVT Registry Web site.

“The TVT Registry will capture and house patient demographics, procedure details, and facility and physician information,” commented STS President Michael J. Mack, MD. “This standardized, evidence-based data source will offer much insight into clinical practice patterns and patient outcomes. I believe this coordinated effort optimizes patient safety and ensures the appropriate use of TAVR therapy.”

ACC President David R. Holmes Jr, MD, added. “The TVT Registry will provide an ideal mechanism for monitoring the use of transcatheter valve therapy. The Registry can provide relatively rapid feedback to individual sites and help identify trends in its usage. The Registry will also provide a rich source of data for long-term research. The ACC is pleased that through the work of the NCDR, we have been able to partner with STS in the development of this new tool and play a role in the thoughtful introduction of this therapy in the United States.”