Mitral-valve repair resulted in no significant difference in left ventricular reverse remodeling (P=0.18) or survival (HR 0.79; 95% CI 0.42-1.47) at 12 months compared to replacement.
RCT (n=251)
Does mitral-valve repair improve left ventricular end-systolic volume index at 12 months compared to chordal-sparing replacement in patients with severe ischemic mitral regurgitation?
In patients with severe ischemic mitral regurgitation, mitral-valve repair did not significantly improve left ventricular reverse remodeling or survival at 12 months compared to replacement, though replacement provided more durable correction of regurgitation.
Absolute Event Rate: 54.6% vs 60.7%
p-value: p=0.18
BACKGROUND: Ischemic mitral regurgitation is associated with a substantial risk of death. Practice guidelines recommend surgery for patients with a severe form of this condition but acknowledge that the supporting evidence for repair or replacement is limited. METHODS: We randomly assigned 251 patients with severe ischemic mitral regurgitation to undergo either mitral-valve repair or chordal-sparing replacement in order to evaluate efficacy and safety. The primary end point was the left ventricular end-systolic volume index (LVESVI) at 12 months, as assessed with the use of a Wilcoxon rank-sum test in which deaths were categorized below the lowest LVESVI rank. RESULTS: At 12 months, the mean LVESVI among surviving patients was 54.6±25.0 ml per square meter of body-surface area in the repair group and 60.7±31.5 ml per square meter in the replacement group (mean change from baseline, -6.6 and -6.8 ml per square meter, respectively). The rate of death was 14.3% in the repair group and 17.6% in the replacement group (hazard ratio with repair, 0.79; 95% confidence interval, 0.42 to 1.47; P=0.45 by the log-rank test). There was no significant between-group difference in LVESVI after adjustment for death (z score, 1.33; P=0.18). The rate of moderate or severe recurrence of mitral regurgitation at 12 months was higher in the repair group than in the replacement group (32.6% vs. 2.3%, P<0.001). There were no significant between-group differences in the rate of a composite of major adverse cardiac or cerebrovascular events, in functional status, or in quality of life at 12 months. CONCLUSIONS: We observed no significant difference in left ventricular reverse remodeling or survival at 12 months between patients who underwent mitral-valve repair and those who underwent mitral-valve replacement. Replacement provided a more durable correction of mitral regurgitation, but there was no significant between-group difference in clinical outcomes. (Funded by the National Institutes of Health and the Canadian Institutes of Health; ClinicalTrials.gov number, NCT00807040.).
Acker et al. (2013) conducted an RCT in Severe ischemic mitral regurgitation (n=251). Mitral-valve repair vs. Chordal-sparing mitral-valve replacement was evaluated on Left ventricular end-systolic volume index (LVESVI) at 12 months, adjusted for death (p=0.18). Mitral-valve repair resulted in no significant difference in left ventricular reverse remodeling (P=0.18) or survival (HR 0.79; 95% CI 0.42-1.47) at 12 months compared to replacement.