Repairing Faulty Heart Valves Without Surgery

Mitral valve regurgitation is a progressive, long-term disorder in which the mitral valve does not close properly and blood leaks backward with each heartbeat, causing the heart to work harder. It affects approximately 4 million people in the United States. About 250,000 develop significant mitral regurgitation annually. Patients with significant mitral regurgitation eventually become so weakened by the condition that they require open-heart surgery to replace or repair the damaged mitral valve. About 44,000 U.S. patients undergo open-heart surgery annually for mitral-valve repair.

Until recently, the only course of treatment for a leaky heart valve was open heart surgery, a major procedure that could take several months of recovery time. Emory Heart & Vascular Center interventional cardiologist Peter Block, MD, has performed several non-surgical repairs of the mitral valve at Emory University Hospital. The innovative procedure uses a catheter to attach a tiny metallic clip to a leaking mitral valve, the heart valve that separates the left upper chamber of the heart from the left lower chamber.

The new procedure is minimally invasive. Under full anesthesia, a catheter (a thin, flexible plastic tube), introduced through the skin in the thigh area, is guided through the femoral vein into the affected area of the heart. A smaller delivery catheter that holds the implantable clip is slipped through this tube, so the clip can be guided into place and attached to the leaflets (the "swinging doors") of the mitral valve. Once the clip is securely attached, the delivery catheter is removed. The entire process is monitored by an echocardiogram. The initial patients returned to normal activity within a few days.

The procedure is under an FDA-approved Investigational Device Exemption, and has been performed on five patients world-wide. The procedure will be under the FDA Exemption through the 10th patient, and then will enter clinical trials.

“The results are showing promise that open heart surgery will not be the only option for patients suffering from mitral valve regurgitation,” says Dr. Block. “There are many benefits — it is much less invasive since it is done through a catheter, and recovery time is quicker.”

To be eligible for the investigational procedure, candidates must have moderate to severe mitral regurgitation and be experiencing symptoms (fatigue, chest pain, shortness of breath); or, lacking these symptoms, they must have a weakened left ventricle.