Doctors Use Tiny Clip to Repair Leaky Heart Valve Without Surgery
The device may help some patients, but a number of doctors still have concerns.
March 15, 2010— -- A tiny clip that holds together "floppy" halves of a leaky heart valve appears to be safer than surgical repair and has comparable efficacy at one year, heart researchers say.
At 30 days less than 10 percent of the patients treated with the clip had complications such as the need for blood transfusions versus 57 percent of the patients who had surgery, said Dr. Tom Feldman of Northshore University Health System in Evanston, Ill., who led a study called EVEREST II in which 136 patients were treated with the device, while 80 patients had surgical repairs. He reported the results at the American College of Cardiology meeting in Atlanta, Ga.
At 12 months, 72 percent of the patients treated with the device, called MitraClip, were still symptom-free or had only minor symptoms. That was good enough to be judged comparable to the surgery patients, even though the surgery results look better at one year with 90 percent of those patients still had a good clinical outcome.
The leaky valve condition, called mitral regurgitation, is diagnosed in about 250,000 Americans every year. When the valve fails to close properly it causes blood to flow backward, which decreases the efficiency of the heart. Patients with severe regurgitation develop irregular heartbeats and heart failure.
Treatment for the condition includes medical therapy, which is used in patients who have only mild symptoms. But in patients with severe symptoms -- meaning they cannot perform normal functions such as walking short distances without experiencing pain or breathlessness, surgical repair of the leaky valve or surgery to replace the valve with a mechanical valve is the gold standard treatment.
The device tested by Feldman is a tiny clip that acts like a clothes pin to hold together the valve flaps.
The clip is mounted on a catheter and then threaded up into the heart through an incision in an artery in the groin.
Unlike surgery patients who have a painful recovery from the open heart procedure, the patients treated with clip are up and walking quickly. "They feel better and don't have the pain that surgery patients experience," Feldman said in an interview with MedPage Today.
