A minimally invasive procedure to repair severe mitral valve regurgitation by clipping together the valve’s leaflets can improve function and quality of life and reduce the risk of hospitalization, research shows. Approximately a third of patients who have the procedure need more than one clip to correct the problem, suggest data being presented at the 27th annual International Symposium on Endovascular Therapy (ISET).
Mitral valve prolapse is a common condition in which the valve’s leaflets don’t close properly. Many people with the condition never have symptoms, but in severe cases the blood leaks backward into the left atrium of the heart. About 250,000 people a year are diagnosed with this condition, called mitral valve regurgitation, which can cause shortness of breath, dizziness, fatigue and an irregular heartbeat. Recently approved by the Food and Drug Administration, the MitraClip holds together the valve’s leaflets to reduce the degree of regurgitation.
“In many cases one clip is sufficient; however in one-third of the patients additional clips are necessary to reduce the degree of regurgitation without producing stenosis, making the valve too tight,” said Ramon Quesada, M.D., medical director of Interventional Cardiology & Cardiac Research for the Miami Cardiovascular Institute. “That’s good news, especially for people with no other options.”
Dr. Quesada was an investigator in the EVEREST II trial, which enrolled 279 patients with severe mitral valve disease. Patients were randomized to either undergo surgical repair (95 patients) or to have the clip placed (184 patients). In the subgroup of patients who were at high risk for surgical repair it was found that the Mitraclip procedure was beneficial because it improved the patient’s cardiovascular function and reduced the rate of hospitalization for heart failure.
Mitral valve regurgitation (also called mitral valve prolapse) is the most common type of heart valve problem in the United States. Every year, about 50,000 people have a severe enough problem that they require surgery, which is the “gold standard” treatment. However, open-heart surgical valve repair is a major procedure requiring heart-lung bypass and prolonged anesthesia. The valve is then replaced or repaired using a variety of techniques. Because many of these patients are older, surgery is often considered too high risk. In the non-surgical transcatheter treatment with MitraClip, the physician threads a catheter through the arteries and advances a clothespin-like clip into the heart’s left atrium where it is positioned to clasp the leaflets together, allowing blood to continue flowing but not back up into the atrium. The device is made of metal and covered with a polyester fabric.