ACC, STS provide updated results on TAVR procedures in the U.S.

In 2015, patients who underwent transcatheter aortic valve replacement (TAVR) had a decrease in in-hospital mortality and one-year mortality and an increase in 30-day post procedure pacemaker insertion, according to a registry analysis.

The results from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (STS/ACC TCT) registry were published online Dec. 9 in the Journal of the American College of Cardiology.

“The improved results are likely related to greater experience, and a lower risk patient population, as well as improving technology and anesthetic techniques,” Frederick L. Grover, MD, vice chair of the TVT registry’s steering committee, said in a news release.

In November 2011, the FDA approved the Sapien valve (Edwards Lifesciences) as the first FDA-approved transcather aortic valve prosthesis. Soon after, CMS issued a national coverage decision for TAVR that required heart teams and hospitals to participate in a prospective, nationally audited registry.

The ACC and STS then worked with the FDA, CMS and device manufacturers to develop the TVT registry, which became operational on Dec. 1, 2011. The registry now consists of three modules: TAVR, transcatheter mitral leaflet clip (TMC) and transcatheter mitral valve-in-valve therapy/transcatheter mitral valve-in-ring therapy (TMViV/TMViR).

At the end of 2015, 418 sites performed TAVR, 176 sites performed TMC and 98 sites performed TMViV and TMViR. As of that time, 54,782 TAVR procedures were entered into the registry, and the number of procedures increased from 4,627 in 2012 to 24,808 in 2015. Meanwhile, from 2013 to 2015, 3,745 TMC procedures and 349 TMViV/TMiVR procedures were performed.

Through the end of 2015, the median age of TAVR patients was 83 years old, while 52 percent were males and 94 percent were white. The median STS predicted risk of mortality was 7 percent during the four-year period, but it decreased to 6 percent in 2015. In addition, the predicted in-hospital mortality was 4 percent, but it declined to 3 percent in 2015.

The use of general anesthesia decreased from 97.6 percent of patients in 2012 to 82.6 percent in 2015. During that same time period, moderate sedation increased from 2.2 percent to 16.6 percent.

The use of the femoral artery access site for valve insertion increased from 75.9 percent in 2012 to 86.6 percent in 2015, while the transapical access decreased from 14.5 percent to 6.1 percent.

In-hospital deaths following TAVR decreased from 5.7 percent in 2012 to 2.9 percent in 2015, while the 30-day mortality decreased from 7.5 percent to 4.6 percent.

Further, the one-year mortality rate decreased from 25.8 percent in 2012 to 21.6 percent in 2015, the in-hospital stroke rate decreased from 2.2 percent to 2.0 percent and the 30-day stroke decreased from 2.3 percent to 1.9 percent.

There were also declines in post-operative atrial fibrillation and major bleeding rates, although the rate of 30-day new pacemaker insertion increased from 8.8 percent in 2013 to 12 percent in 2015.

The researchers cited a few limitation of the registry, including data completeness and accuracy. They mentioned that the TVT steering committee monitors data quality and a separate task force is conducing an analysis of the registry’s data quality, completeness and accuracy. They wrote that “data completeness has slowly improved over the four years of data collection; in-hospital data completeness is relatively good, but the 30-day and one-year data collection needs improvement.”

“The registry acts a lens showing us where we have been and where we are now, and it helps shape the future of where we are going,” David R. Holmes Jr., MD, chair of the TVT registry’s steering committee, said in a news release. "This annual report is a cornerstone of the mission of the TVT Registry to monitor our performance in optimizing health care of the growing number of patients with structural heart disease.”