In some people, however, the mitral valve can leak, usually because of a congenital deformity or after a serious heart attack when the heart muscle itself is damaged. "Significant leakage of the mitral valve can shorten someone's life, not to mention making it tough to go about the activities of daily living," said Dr Scott Lim, a cardiologist at the University of Virginia Health System.
For years, the standard of care for mitral valve leakage has been open-heart surgery with the patient on a bypass machine. Now, heart patients at the UVa Health System have a new, less invasive, option to get a leaky valve fixed.
The UVa Health System is part of a national, randomized clinical trial of a tiny, permanent, implanted device made out of titanium called the MitraClip, which 'clips' the leaky halves of the mitral valve together without major surgery. The MitraClip procedure starts with a catheter in a patient's leg vein. The catheter, with the clip inside, is gently threaded to the heart to the part of the mitral valve that is leaking the most. Doctors then repair the valve via the catheter by putting the MitraClip clip on it with special hooks.
"The obvious advantage is that this is less invasive than open-heart surgery and patients can heal quicker," Lim said. "The procedure is done on an outpatient basis with an overnight observation. Patients can go home the very next day with no pain from open chest surgery."
Lim is the principal investigator at UVa for the trial, called EVEREST 2. He said the trial should help doctors know if the mitral valve clip is as effective as standard open- heart surgery. "We think this is as safe or safer but part of the purpose of the trial is to determine that for sure. So far, in 49 patients around the U.S. there have been no major life-threatening complications," Lim said.
General criteria for patients to be included in the trial are: over age 18 with significant mitral valve leakage and a candidate for mitral valve surgery. Patients in the study are randomized to either the MitraClip device or mitral valve surgery at UVa, and are required to have follow-up at set intervals at UVa for the study duration. For more information on the EVEREST 2 trial at UVa, contact Dr Scott Lim at (434) 924-9119 or Linda Bailes, RN, at (434) 982-1058.