FDA Approves Innovative Valve for Treatment of Aortic Stenosis

November 2011

The FDA has approved the SAPIEN transfemoral transcatheter heart valve, which is expected to revolutionize the treatment of severe aortic stenosis in those patients considered inoperable by traditional surgical technique. Developed by Edwards Lifesciences, the valve offers a new non-surgical treatment known as transcatheter aortic valve replacement (TAVR) for patients with failing aortic valves. Since 2007, Drs. Robert Guyton and Vinod Thourani, in cooperation with Emory interventional cardiologists Drs. Peter Block and Vasilis Babaliaros, were the Local Surgical Co-PIs of the Emory University Hospital-based location of the nationwide, multi-center trial that laid the groundwork for the FDA's decision.

TAVR is an innovative, non-invasive method of replacing diseased aortic heart valves in patients suffering from severe aortic stenosis that are too frail or sick to withstand the traditional open-heart surgical approach. The life threatening heart condition affects tens of thousands of Americans each year when the aortic valve tightens or narrows, preventing blood from flowing through normally.

During the TAVR procedure, doctors create a small incision in the groin or chest wall and then feed the new valve made of cow heart tissue, mounted on a wire mesh on a catheter, and place it where the new valve is needed. The Emory research team compared the procedure with traditional, open-heart surgery or medication therapy in high-risk patients, performing over 200 TAVR implants in the process — Emory was one of the highest volume centers participating in this clinical trial.

Study results published in the September 2010 and June 2011 editions of the New England Journal of Medicine showed reduced mortality among patients treated with TAVR and concluded that the procedure should be the new standard of care for patients who are unable to undergo traditional therapies.

"This landmark trial and consequent approval by the FDA of the transfemoral aortic valve replacement device will radically alter the management of the inoperable, yet viable patient population with severe aortic stenosis," said Dr. Thourani. "For the first time, we will be able to provide a truly surgical treatment for aortic stenosis without the deleterious aspects of cardiopulmonary bypass and a median sternotomy. We are fortunate that our multi-disciplinary heart valve team of cardiologists and cardiac surgeons will be able to provide this innovative technology to the citizens of Atlanta and our patients here at Emory University."

Further information regarding this technology should be addressed to 404-686-2513.