Study Confirms TAVR is Safe, Effective for Aortic Valve Replacement in Select Patients

STS News, Winter 2014 -- The first public report from the STS/ACC TVT Registry™ shows that transcatheter aortic valve replacement for treatment of aortic stenosis in high surgical risk and inoperable patients in the United States is safe and effective, confirming results of pre-market clinical trials.

Led by STS Past President Michael J. Mack, MD, researchers used data from the TVT Registry to develop a study published in the November 20 issue of The Journal of the American Medical Association (JAMA), a theme issue on cardiovascular health.

“The large volume of data in the Registry provided an excellent source to promptly examine patient characteristics and outcomes,” said Dr. Mack, who is also Chair of the STS/ACC TVT Registry Steering Committee.

The TVT Registry was launched in December 2011, shortly after FDA approval of the SAPIEN transcatheter heart valve. In May 2012, the Centers for Medicare & Medicaid Services required all hospitals performing TAVR to capture clinical information in the TVT Registry as a requirement for Medicare coverage. The TVT Registry resulted from the joint efforts of STS, ACC, FDA, CMS, the National Institutes of Health, and Duke Clinical Research Institute.

The analysis published in JAMA included 7,710 patients who underwent TAVR at one of 224 participating sites. Successful device implantation occurred in 7,069 patients (92%). In-hospital mortality was 5.5%. Other major complications included stroke (2.0%), dialysis-dependent renal failure (1.9%), and major vascular injury (6.4%).

Median hospital stay was 6 days, with 4,613 patients (63%) discharged home. Among the 3,133 patients with available follow-up data at 30 days, mortality was 7.6% (noncardiovascular cause, 52%) and stroke occurred in 2.8%.

“Given the low in-hospital mortality and stroke rates, our real-world results from this newly introduced technology are similar to the success rates and complication patterns documented in carefully performed randomized trials that resulted in FDA approval,” said Dr. Mack. “The results are also similar to the global experience of TAVR, which is now based on second- and third-generation devices. We think that the American public can feel comfortable that this new registry is an effective means of monitoring the performance of new medical devices after they have been approved.” He cautioned, however, that longer term follow-up is essential to assess continued safety and efficacy, as well as patient health status.

Future of the TVT Registry
The TVT Registry currently has more than 10,000 patient records, and that number is expected to double in the next year. The large number of patient records allows for the development of reliable benchmarks for centers to compare their local results against risk-adjusted national standards.

“We envision the TVT Registry as an evolving portfolio of device registries, as part of the FDA’s new strategic plan for post-market device surveillance,” said STS Research Center Director Fred H. Edwards, MD, another study author. “As new medical devices are approved in the United States, we intend to incorporate experience with these devices into the Registry. This should provide a streamlined approach to national device surveillance and open up new avenues into research focused on the risks and benefits of medical device products.”