“Alternative Access” TAVR Study Will Examine Benefits of Non-Femoral Access

STS News, Summer 2013 -- STS has launched an investigational study with the American College of Cardiology that may allow more patients to benefit from transcatheter aortic valve replacement (TAVR).

TAVR using the Edwards SAPIEN valve was recently approved in the United States for inoperable or high-risk patients with aortic stenosis. For most patients, the transfemoral approach is used, but some patients have too much disease in the femoral artery to permit using this approach.

The transapical approach to TAVR, as shown here, is one of the “alternative access” methods being studied for safety and efficacy. Photo courtesy of Edwards Lifesciences

The new study will evaluate the safety and efficacy of “alternative access” approaches for TAVR, including transapical, transaortic, transsubclavian/transaxillary, and transiliac.

“An estimated 1 in 4 patients has been ineligible for TAVR because advanced disease precludes use of the FDA-approved access site,” said STS Research Center Director Fred Edwards, MD, Emeritus Professor of Surgery at the University of Florida, Jacksonville, and one of the study’s principal investigators. “This trial will determine whether ‘alternative access’ procedures are as safe and effective as procedures using the presently approved approaches.”

Earlier this year, the US Food and Drug Administration granted STS and the ACC a unique investigational device exemption (IDE) to study the alternative access approaches using the STS/ACC TVT Registry™, which is a device surveillance and benchmarking tool the two organizations developed to track clinical outcomes and improve patient safety. The IDE is believed to be the first sponsored by any medical specialty society.

The study will use TVT Registry data pertaining to inoperable patients aged 18 years and older who undergo TAVR for severe aortic stenosis using any non-femoral access approach with an Edwards SAPIEN valve between now and December 31, 2018.

The primary analysis will be performed when data on the first 1,000 evaluable patients are available.

“Implementing this study through the STS/ACC TVT Registry provides a unique opportunity to enroll a very diverse group of patients from a number of different institutions, providing us with a large sample population in which to study alternative access,” said Dr. Edwards. “This level of collaboration and use of registries will enable us to gather accurate information that may ultimately lead to label expansion.”

Four principal investigators—including Dr. Edwards; John Carroll, MD, from the American College of Cardiology; and J. Matthew Brennan, MD, MPH, and Sean O’Brien, PhD, from Duke University—will oversee the study.

As of early July, 239 US institutions were enrolled in the TVT Registry. The institutions are located in 46 states and the District of Columbia.