The Hospital of the University of Pennsylvania (HUP) is participating in a nationwide clinical trial of a new valve repair device that could replace major heart surgery in some patients.
A tiny clip - delivered by a catheter and deployed in the heart to repair a malfunctioning and leaking mitral valve - is building a favorable safety and feasibility profile as the EVEREST Phase I clinical trial nears completion.
Severe mitral valve regurgitation (MR) is a debilitating condition that causes shortness of breath, fatigue and palpitations. In the United States, about 250,000 people develop significant MR each year, with almost 50,000 requiring surgery. The clip is designed to secure the valve's leaflets near the center of the valve so that blood leakage is minimized and the heart pumps more efficiently. This new device could decrease a patient's hospital stay, result in fewer complications, provide a quicker recovery time, and significantly reduce health care costs. "In my most recently treated patient, we utilized two clips to reduce his MR from severe to mild. It has been six months since his procedure, and he has no symptoms whatsoever," says Howard C. Herrmann, MD, Director of Interventional Cardiology & the Cardiac Catheterization Laboratory at Penn, and principal investigator for HUP's component of the EVEREST Trial.
"The development and clinical evaluation of this device are paving the way for percutaneous, or through the skin, valve repair. We are at the beginning of an exciting new avenue in interventional cardiology. I have no doubt that in five or ten years, interventional cardiologists will be routinely treating valvular heart disease in many patients without cardiac surgery," adds Dr. Herrmann.
To date, a total of 24 patients who suffered from significant MR have received the clip as part of the EVEREST I clinical study under an FDA- approved investigational device exemption (IDE). The clip is a product of Evalve Inc., a medical device company, and the sponsor of the trial. Based on these promising results, a larger, Phase II safety and efficacy trial may be initiated later this year.
Dr. Herrmann presented an update of the trial's findings today at the American Heart Association's Scientific Sessions 2004 in New Orleans during a presentation entitled "Percutaneous Edge-to-Edge Mitral Valve Repair: Preliminary Results of the EVEREST- I Study."
To be eligible for the investigational procedure, candidates must have moderate-to-severe or severe MR and be experiencing symptoms (fatigue, chest pain, shortness of breath); or, lacking these symptoms, they must have a weakened left ventricle (heart muscle).
Performed in the cardiac catheterization lab, the initial procedures have taken approximately two to four hours. Under full anesthesia, a catheter (a thin, flexible plastic tube) is introduced through the skin in the thigh area and guided through the femoral vein to the affected area of the heart. A smaller delivery catheter that holds the clip is slipped through this tube so that the clip can be guided into place and attached to the leaflets (the "swinging doors") of the mitral valve. Once the clip is attached, the delivery catheter is removed. The entire process is monitored by an echocardiogram. The hospital stay has generally been two nights; and most patients returned to normal activity within one week.