ACC: Mitral Regurgitation Approaches Evaluated

Percutaneous repair less effective at reducing mitral regurgitation but safer than surgery

TUESDAY, April 5 (HealthDay News) -- Percutaneous repair that involves implantation of a mitral clip appears to be less effective at reducing mitral regurgitation than conventional surgery but seems to be associated with superior safety and similar improvements in other clinical outcomes, according to research published online April 4 in the New England Journal of Medicine to coincide with the American College of Cardiology's 60th Annual Scientific Session & Expo, held from April 2 to 5 in New Orleans.

Ted Feldman, M.D., of Evanston Hospital in Illinois, and colleagues randomized 279 patients with moderately severe or severe (grade 3+ or 4+) mitral regurgitation in a 2:1 ratio to undergo either percutaneous repair or conventional surgery for repair or placement of the mitral valve. The primary composite end point for efficacy was freedom from death, from surgery for mitral-valve dysfunction, and from grade 3+ or 4+ mitral regurgitation at 12 months. The primary end point for safety was a composite of major adverse events within 30 days.

The investigators found that the rates of the primary end point for efficacy were 55 percent in the percutaneous-repair group and 73 percent in the surgery group at 12 months. The rates of surgery for mitral-valve dysfunction were 20 percent in the percutaneous-repair group and 2 percent in the surgery group, and the rates of grade 3+ or 4+ mitral regurgitation were 21 and 20 percent, respectively. The death rate was 6 percent in each group. The investigators also found that major adverse events occurred in 15 percent of patients in the percutaneous-repair group and 48 percent of patients in the surgery group at 30 days.

"Ideally, any new procedure would also be at least equivalent to surgical valve repair in terms of safety, valve function, durability, and long-term outcomes," write the authors of an accompanying editorial. "The mitral-valve clip that was evaluated in this study fulfills some, but not all, of these criteria."

The study was supported by Abbott Vascular, the manufacturer of the clip used for percutaneous repair (MitraClip) in this study. Several authors disclosed financial relationships with pharmaceutical, biotechnology, and medical device companies, including Abbott.

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