Submitted by Armen Hareyan on Jun 27th, 2008
Beaumont is the first hospital in metro Detroit to treat patients in a clinical study evaluating the MitraClip system to repair the mitral valve without open-heart surgery. The MitraClip device is used for patients with moderately severe to severe mitral regurgitation, the most common type of heart valve problem. With the clip, Beaumont interventional cardiologists and echocardiologists are able to repair defective mitral valves with a nonsurgical procedure in the cardiac catheterization lab in about two hours.
Beaumont is one of about 40 centers in North America evaluating the safety and effectiveness of this percutaneous (through the skin) procedure. The system is made by Evalve Inc. of Menlo Park, Calif. Participants in the study are randomized to receive the catheter-based repair with the MitraClip device or traditional open-heart valve repair or replacement.
"The results of the first patient are very encouraging," says George Hanzel, M.D., Beaumont's director of valvular and congenital heart disease and principal investigator for the study. "This device could potentially be an alternative treatment for some patients with mitral valve regurgitation."
Dr. Hanzel led a team of specialists in Beaumont's first procedure on 77-year-old Josephine Herndon of Rochester Hills. The patient did very well, was released from the hospital less than 48 hours after the procedure and at her 30-day follow-up visit reported a significant improvement in her symptoms of fatigue and shortness of breath. The hospital stay for surgical mitral valve repair can be up to five days.
During the procedure, a catheter (a thin, flexible plastic tube) is inserted through the patient's skin in the groin area and is guided through the femoral vein to the affected area of the heart. Then, a catheter that holds the MitraClip device goes in through the first catheter so that the clip can be guided into place and attached to the leaflets of the mitral valve. Once the clip is properly placed and securely attached, it is deployed and the catheters are removed. The entire process is monitored with echocardiography.
An estimated 4 million people in the United States have significant mitral valve regurgitation with about 250,000 newly diagnosed patients each year. In these patients, the leaflets or flaps of the mitral valve (the valve separating the left atrium and left ventricle) do not close properly. Blood then leaks backward through the valve with each heartbeat, causing the heart to work harder to circulate blood.
Enrollment in the clinical trial, EVEREST II, is open to patients who have moderately-severe mitral valve regurgitation and who are surgical candidates. Call Beaumont's Cardiology Research department at 248-898-5589 for more information or to see if you qualify for the study.
There are no drugs to specifically treat mitral regurgitation, though some drugs can help manage symptoms. The current standard of care is open-heart surgery to repair or replace the mitral valve. Beaumont surgeons are leaders in minimally invasive approaches for mitral valve surgery. Patients who do not qualify for the MitraClip procedure may qualify for a minimally invasive surgical approach. Surgical mitral valve repair has a mortality rate of less than one percent.
Source:
Beaumont Medical Center 