Mitral Valve Clip Improves Valve Regurgitation Symptoms

Researchers at NorthShore University (Evanston, IL USA), reported the phase II results of the Endovascular Valve Edge-to-Edge REpair Study (EVEREST II trial), a multi-center, randomized clinical trial involved 279 patients (mean age 68) with moderate-to-severe or severe MR who were candidates for mitral valve surgery. Patients in the trial tended to have more comorbidities--such as hypertension and congestive heart failure (CHF)--than the average surgical patient. The patients were either symptomatic or asymptomatic with evidence of compromised left ventricular function, atrial fibrillation, or pulmonary hypertension.

The one-year follow-up of the study showed that only 9.6% of the 279 patients that had received the MitraClip had safety issues associated with the procedure, compared to 57% of the open-heart surgery patients. Conversly, in terms of effectiveness, 72.4% of the MitraClip patients had successful reduction of MR, compared to 87.8% of the surgical patients. Importantly, patients treated with the MitraClip could still have traditional surgery if needed. The study results were presented at the American College of Cardiology annual conference, held during February 2010 in Atlanta (GA, USA)

"This is a major advancement in cardiac care,” said lead author and study presenter Ted Feldman, M.D, director of NorthShore's cardiac catheterization laboratory. "It's the first catheter-based therapy for a mitral valve problem to complete a trial, and has transformed the lives of patients suffering from moderate to severe mitral regurgitation.”

The MitraClip is a 4 mm-wide, polyester-covered device developed by Abbott Vascular (Abbott Park, NJ, USA). Under general anesthesia, the clip is inserted via catheter through an artery in the groin, threaded up to the heart, and clamped to the mitral valve's two edges to hold them together. The heart beats normally during the procedure, and therefore does not require a heart-lung bypass machine.

Related Links:
NorthShore University
Abbott Vascular