Less invasive cath lab procedure may replace major open-heart surgery
March 9, 2004--A tiny metallic clip that can be delivered and attached to the heart's mitral valve with a catheter may eliminate the need for open-heart surgery in some patients who suffer from significant mitral regurgitation (MR). A debilitating condition, MR occurs when the valve, which allows blood to move through the heart, fails to close properly.
Early experience with the clip, which is being evaluated under an FDA approved Investigational Device Exemption, has been encouraging, says Principal Investigator Ted Feldman, MD, Director of the Cardiac Catheterization Lab at Evanston Hospital, flagship of the Evanston Northwestern Healthcare system. Evalve, Inc. (Redwood City, CA) developed and manufactures the system.
Dr. Feldman will present results of the Phase I trial at 9 a.m. CST Tuesday, March 9, at the American College of Cardiology Conference, Morial Convention Center, Hall A, New Orleans. The presentation, part of the Late-Breaking Clinical Trials II group, is titled Percutaneous Mitral Valve Repair Using the Edge-to-Edge Technique: Phase I US Trial Results.
To date, a total of 10 percutaneous mitral valve repairs using this device have been performed nationwide. Dr. Feldman performed the first U.S. procedure in Evanston Hospital's Cardiac Catheterization Laboratory. Other U.S. investigators participating in the trial are: Howard Herrmann, MD, University of Pennsylvania; Peter Block, MD, Emory University Hospital, Atlanta; Pat Whitlow, MD, Cleveland Clinic Foundation; William Gray, MD; Swedish Medical Center, Seattle; Kenneth Kent, MD, Washington Hospital Center, Washington, DC; and Hal Wasserman, MD, Columbia University Medical Center, New York.
"Collectively, we have used the clip in 10 patients without complications during the procedure. Prior to the catheter procedure all 10 patients had MR serious enough to require surgery. The majority of the patients treated with the device had their MR significantly reduced so as to no longer need surgery. The patients who did not receive optimal MR control with the clip were able to have routine, successful mitral valve surgery as previously indicated," explains Dr. Feldman.
In chronic MR, blood leaks backward with each heartbeat, requiring the heart to work harder. It's a progressive disorder that affects approximately 4 million people in the United States. Approximately 250,000 patients develop significant mitral regurgitation annually in the US.
Patients with significant mitral regurgitation eventually become so weakened by the condition that they require open-heart surgery with cardiopulmonary bypass. Approximately 50,000 people a year have open, arrested-heart mitral valve surgery.
To be eligible for the investigational procedure, candidates must have moderate to severe or severe mitral regurgitation 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 a cardiac catheterization laboratory, the initial procedures have taken 2-4 hours. Under general anesthesia, a catheter (a thin, flexible plastic tube) introduced through the skin in the thigh area, is guided from the femoral vein to the affected area of the heart. The clip is precisely steered into place and attached to the mitral valve, helping it to close properly. Once the clip is securely attached, the catheter is removed. The procedure is performed using echocardiography and fluoroscopy. The hospital stay has been one to two nights and patients generally returned to normal activity within one week. As experience with the procedure grows, Dr. Feldman expects that it will require less time and may utilize local anesthesia. In follow-up visits with patients who received the clip, Dr. Feldman has observed the device working according to design. "When I saw our second patient for follow-up, he had no heart murmur at all!" Dr. Feldman says.
"This new clip is one of the interventional cardiology devices in the pipeline that will change the face of cardiology in the coming years," says Dr. Feldman. "We are beginning to see an array of devices that are intended to repair or replace malfunctioning structures of the heart without surgical intervention. Recovery times will be reduced from weeks to just days," he adds.
Source: Eurekalert & othersLast reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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