Heart Valve Repair without Surgery Now FDA-Approved

Several clinical trials conducted, in part, at Baptist Cardiac & Vascular Institute, have lead to the U.S. Food and Drug Administration’s (FDA) approval of an implantable device to repair mitral valve prolapse, or a heart valve that doesn’t close all the way. When the valve fails to close, blood flows backward in the heart – a condition known as mitral valve regurgitation.

Interventional cardiologists, like the Institute’s Ramon Quesada, M.D., implant the device, MitraClip (manufactured by Abbott Laboratories), into patients by making a puncture in the skin of the groin and threading a catheter with the clip up to the heart valve through an artery in the leg. The clip grasps the two leaflets that make up the valve and helps them close.

During the trial, Dr. Quesada implanted nearly 50 of these devices in patients with good outcomes. He was the only doctor in Florida chosen to implant the device to test its effectiveness.

The American Heart Association estimates that 2-3 percent of Americans live with mitral valve prolapse. Mitral valve regurgitation, resulting from that prolapse, can lead to complications such as heart failure, abnormal heartbeats or arrhythmias, and blood clots that may lead to stroke or heart attacks, the National Institutes of Health says.

“The approval of this device means an alternative for some people who need their valve repaired, but who are not candidates for surgery,” Dr. Quesada said. But, he warns, the clip is not for everyone. “Only one out of five patients we evaluate will be a candidate to use the clip in place of surgery.”

Patients who do get the clip benefit from a quicker recovery than with traditional open-heart surgery that requires a large incision and cracking of the ribs.