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MitraClip Safely Relieves Symptoms in Patients With No Surgical Options
Date:5/6/2010

0,000 patients newly diagnosed with mitral regurgitation in the United States each year, only about 20 percent have surgery. The rest are either too high-risk or not yet sick enough for surgery.

The MitraClip is an investigational device that has not yet been approved by the FDA. During the procedure, the device is mounted on a catheter and advanced into the heart via a vein in the groin. The clip is centered directly across the center of the valve and the leaflets are clipped together in the middle, converting a leaky single orifice mitral valve into a competent double-orifice valve. The entire procedure is done on a beating heart using x- ray and ultrasound to guide the procedure.

For the study, interventional cardiologists recruited 78 patients with severe mitral regurgitation (classified as moderate-to-severe, or severe) who were considered to be at very high risk for surgery. The average age of patients was 77 years. All patients had congestive heart failure, and 90 percent were in New York Heart Association (NYHA) class III or IV, meaning they were experiencing marked limitation of physical activity or even shortness of breath while resting. Some 60 percent of patients had previously undergone cardiac surgery, 85 percent had coronary artery disease, 35 percent had chronic lung disease, and 23 percent had moderate-to-severe kidney failure. According to a formula developed by the Society of Thoracic Surgeons, the average predicted risk of surgery-related death was 18.2 percent.

The placement of the MitraClip was successful in 96 percent of patients, with no procedural deaths. Within the first 30-days, mortality was 7.7 percent, which was significantly lower than the predicted 18.2 percent surgical mortality (p=0.008) and not significantly different from the 8.3 percent mortality in a matched control group who were treated with medica
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SOURCE Society for Cardiovascular Angiography and Interventions
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