CardioExchange Archive

Following the approval of the first device for transcathether aortic valve replacement therapy (TAVR) earlier this month, the Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC) have announced the launch of the TVT Registry, a joint initiative that will monitor the rollout of the new technology.

The registry was created in response to the concern, expressed by panel members at the FDA advisory panel last summer, that excessive enthusiasm for the Edwards Sapien device might cause a stampede of early usage. Panel members were afraid that the device might be used in patients who were not ideal candidates or by operators and centers who lacked sufficient experience. In announcing the approval of the Sapien device, the FDA said that the registry “will serve as a platform for continued evaluation of post market experience with this and future transcatheter devices and procedures for the treatment of aortic stenosis.”

The ACC and STS are bringing the “registry expertise” they have gained through experience with the STS National Database and the ACC’s National Cardiovascular Data Registry (NCDR). The new registry will serve “as the main repository for all clinical data related to TAVR and is positioned to incorporate additional catheter-based procedures that have yet to come to market in the United States,” according to the ACC and STS.

“The TVT Registry will capture and house patient demographics, procedure details, and facility and physician information,” said Michael J. Mack, president of the STS, in a press release. “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.”

“The TVT Registry will provide an ideal mechanism for monitoring the use of transcatheter valve therapy,” said David R. Holmes, Jr., president of the ACC, in a press release. “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.”

For the first year, hospitals will be charged $25,000 to participate in the registry. Subsequent years will cost $10,000.