Mitral-valve repair can be accomplished with an investigational procedure that involves
the percutaneous implantation of a clip that grasps and approximates the edges of
the mitral leaflets at the origin of the regurgitant jet.
We randomly assigned 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 replacement 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 safety end point
was a composite of major adverse events within 30 days.
At 12 months, the rates of the primary end point for efficacy were 55% in the percutaneous-repair
group and 73% in the surgery group (P=0.007). The respective rates of the components
of the primary end point were as follows: death, 6% in each group; surgery for mitral-valve
dysfunction, 20% versus 2%; and grade 3+ or 4+ mitral regurgitation, 21% versus 20%.
Major adverse events occurred in 15% of patients in the percutaneous-repair group
and 48% of patients in the surgery group at 30 days (P<0.001). At 12 months, both
groups had improved left ventricular size, New York Heart Association functional class,
and quality-of-life measures, as compared with baseline.
Although percutaneous repair was less effective at reducing mitral regurgitation than
conventional surgery, the procedure was associated with superior safety and similar
improvements in clinical outcomes. (Funded by Abbott Vascular; EVEREST II ClinicalTrials.gov