FDA approves transcatheter heart valve for aortic valve-in-valve procedures

Edwards Lifesciences announced that the FDA has approved the Sapien XT transcatheter heart valve for use in aortic valve-in-valve procedures, according to a press release.

Perspective from Gregg W. Stone, MD

“U.S. approval of the valve-in-valve procedure provides an important, minimally invasive treatment option for patients who are at high risk for a subsequent open-heart surgery to replace their bioprosthetic valves,” Larry L. Wood, vice president of transcatheter heart valve therapy at Edwards Lifesciences, said in the release.

The Sapien XT valve (Edwards Lifesciences) received FDA approval in 2014 for treatment of high-risk and inoperable patients with severe aortic stenosis. The approval for valve-in-valve procedures follows results from the multicenter, nonrandomized PARTNER II Valve-in-Valve study, which included 97 patients from the PARTNER II trial enrolled in a primary registry and 100 continued-access patients. In the Valve-in-Valve study, Sapien XT was associated with a 1-year survival rate of 86.6% and a stroke rate of 3.7%, according to the release.

Danny Dvir, MD, interventional cardiologist at the Center for Heart Valve Innovation at St. Paul’s Hospital in Vancouver, British Columbia, Canada, said in the release that the researchers observed a 100% survival rate at 30 days among the 100 patients in the continued access registry. “This is quite remarkable and supports transcatheter aortic valve-in-valve replacement with the Sapien XT valve as a safe therapeutic alternative to reoperation for patients in need of a subsequent tissue valve replacement,” he said.

Disclosure: Wood is an employee of Edwards Lifesciences. Dvir reports consulting for Edwards Lifesciences and Medtronic.

Perspective

Gregg W. Stone, MD

This is a very interesting and important area. A lot of experience has accumulated doing valve-in-valve procedures, which are simpler and have had better outcomes than valve-in-ring procedures. The FDA approval is important because this is a very high-risk population of patients who are very difficult to manage with a repeat operation. This will increase the interest level for learning how to do this procedure to improve outcomes for those patients. It’s a very positive event for the field.

Gregg W. Stone, MD

Cardiology Today’s Intervention Editorial Board Member

Professor of Medicine, Columbia University

Director of Cardiovascular Research and Education, Columbia University Medical Center / New York-Presbyterian Hospital

Co-Director, Medical Research and Education, Cardiovascular Research Foundation

Disclosures: Stone reports consulting for Reva Medical.