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FDA Approves New Valve Replacement Procedure for High-Risk Patients

Transcatheter aortic valve replacement, a cardiac procedure considered a “game changer” by many physicians, was approved by the U.S. Food and Drug Administration (FDA) in November. Through the procedure, physicians are for the first time able to replace aortic valves percutaneously.

The device, called the SAPIEN valve and developed by Edwards Lifesciences, consists of a valve made of cow heart tissue attached to a collapsible mesh stent.

The Washington University and Barnes-Jewish Heart & Vascular Center was one of only 23 U.S. centers to participate in the PARTNER (Placement of AoRTic traNscathetER valves) trial leading to the FDA’s approval.

“This has the potential to supplant the open procedure for high-risk patients,” says Ralph Damiano Jr., MD, chief of cardiac surgery at Barnes-Jewish and Washington University School of Medicine, who, with John Lasala, MD, PhD, serves as co-principal investigator of the trial at the university.“This is a phenomenal thing for patients who were not able to do their daily routine due to aortic stenosis,” says Alan Zajarias, MD, Washington University interventional cardiologist at Barnes-Jewish Hospital. “If they were not surgical candidates previously, we can now do something to help them live longer and feel better.”

Other physicians conducting the trial are Hersh Maniar, MD, cardiac surgeon; Brian Lindman, MD; and Zajarias, who spent six months in France training with the procedure’s developer, Alain Cribier, MD, chief of cardiology at the University Hospital in Rouen, France.

About 100,000 Americans over age 65 receive new aortic valves each year, while 30,000 more are in need of a replacement valve but can’t get it because the method of replacement—open-heart surgery—might kill them.

The FDA panel decision currently only applies to those patients who are not good surgical candidates. However, in the coming year, physicians hope the FDA also will approve the procedure for those considered high-risk surgical candidates but who can still have surgery. Surgery is still the treatment of choice for those who are surgical candidates.

Learn more about the new valve-replacement procedure here.

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