Mitral-valve repair versus replacement for severe ischemic mitral regurgitation.
Mitral-valve repair versus replacement for severe ischemic mitral regurgitation.
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DOI：
10.1056/nejmoa1312808
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发表时间：
2014-01-02
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通讯作者：
CTSN
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作者：
Acker MA;Parides MK;Perrault LP;Moskowitz AJ;Gelijns AC;Voisine P;Smith PK;Hung JW;Blackstone EH;Puskas JD;Argenziano M;Gammie JS;Mack M;Ascheim DD;Bagiella E;Moquete EG;Ferguson TB;Horvath KA;Geller NL;Miller MA;Woo YJ;D'Alessandro DA;Ailawadi G;Dagenais F;Gardner TJ;O'Gara PT;Michler RE;Kron IL;CTSN
缺血性二尖瓣反流与相当大的死亡风险相关。实践指南建议对患有这种严重疾病的患者进行手术，但也承认修复或置换的支持证据有限。
我们将251例严重缺血性二尖瓣反流患者随机分配接受二尖瓣修复或保留腱索的置换术，以评估疗效和安全性。主要终点是12个月时的左心室收缩末期容积指数（LVESVI），采用Wilcoxon秩和检验进行评估，其中死亡病例归类于最低LVESVI秩之下。
在12个月时，存活患者中修复组的平均LVESVI为每平方米体表面积54.6±25.0毫升，置换组为每平方米60.7±31.5毫升（与基线相比的平均变化分别为每平方米 -6.6毫升和 -6.8毫升）。修复组的死亡率为14.3%，置换组为17.6%（修复的风险比为0.79；95%置信区间为0.42 - 1.47；对数秩检验P = 0.45）。校正死亡因素后，LVESVI在两组间无显著差异（z评分1.33；P = 0.18）。12个月时二尖瓣反流中度或重度复发率在修复组高于置换组（32.6%对2.3%，P<0.001）。在12个月时，主要不良心脏或脑血管事件复合发生率、功能状态或生活质量在两组间无显著差异。
我们观察到接受二尖瓣修复的患者和接受二尖瓣置换的患者在12个月时左心室逆向重构或生存率无显著差异。置换对二尖瓣反流的矫正更持久，但临床结果在两组间无显著差异。（由美国国立卫生研究院和加拿大卫生研究院资助；ClinicalTrials.gov编号，NCT00807040）
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. 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. 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. 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.)