Department of Cardiovascular Anesthesia and Intensive Care, Cardiocentro Ticino, Lugano, Switzerland.
Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Int J Cardiol. 2018 Jan 15;251:22-31. doi: 10.1016/j.ijcard.2017.10.077. Epub 2017 Oct 21.
Several studies suggested beneficial effects of perioperative levosimendan on postoperative outcome after cardiac surgery. However, three large randomized controlled trials (RCTs) have been recently published and presented neutral results. We performed a systematic review with meta-analysis and trial sequential analysis (TSA) to assess benefits and harms of perioperative levosimendan therapy in cardiac surgery.
Electronic databases were searched up to September 2017 for RCTs on preoperative levosimendan versus any type of control. The Cochrane methodology was employed. We calculated odds ratio (OR) or Risk Ratio (OR) and 95% confidence interval (CI) using fixed-effects meta-analyses and we further performed TSA.
We included data from 40 RCTs and 4246 patients. Pooled analysis of 5 low risk of bias trials (1910 patients) showed no association between levosimendan and mortality (OR 0.86 [95% CI, 0.62, 1.18], p=0.34, TSA inconclusive), acute kidney injury, need of renal replacement therapy, myocardial infarction, ventricular arrhythmias, and serious adverse events, but an association with higher incidence of supraventricular arrhythmias (RR 1.11 [95% CI, 1.00, 1.24], p=0.05, TSA inconclusive) and hypotension (RR 1.15 [95% CI, 1.01, 1.30], p=0.04, TSA inconclusive). Analysis including all 40 trials found that levosimendan was associated with lower postoperative mortality (OR 0.56 [95% CI, 0.44, 0.71], p<0.00001, TSA conclusive), acute kidney injury, and renal replacement therapy, and higher incidence of hypotension.
There is not enough high-quality evidence to neither support nor discourage the systematic use of levosimendan in cardiac surgery.
几项研究表明心脏手术后围手术期左西孟旦对术后转归有益。然而，最近发表了三项大型随机对照试验（RCT），结果呈中性。我们进行了系统评价和荟萃分析以及试验序贯分析（TSA），以评估心脏手术中围手术期左西孟旦治疗的益处和危害。
截至 2017 年 9 月，电子数据库中检索了术前左西孟旦与任何类型对照的 RCT。采用 Cochrane 方法。我们使用固定效应荟萃分析计算了比值比（OR）或风险比（OR）和 95％置信区间（CI），并进一步进行了 TSA。
我们纳入了 40 项 RCT 和 4246 例患者的数据。5 项低偏倚风险试验（1910 例患者）的汇总分析显示，左西孟旦与死亡率（OR 0.86 [95％CI，0.62，1.18]，p=0.34，TSA 不确定），急性肾损伤，需要肾脏替代治疗，心肌梗死，室性心律失常和严重不良事件之间无关联，但与室上性心律失常（RR 1.11 [95％CI，1.00，1.24]，p=0.05，TSA 不确定）和低血压（RR 1.15 [95％CI，1.01，1.30]，p=0.04，TSA 不确定）的发生率较高有关。包括所有 40 项试验的分析发现，左西孟旦与术后死亡率（OR 0.56 [95％CI，0.44，0.71]，p<0.00001，TSA 结论性），急性肾损伤和肾脏替代治疗以及低血压发生率较低有关。
没有足够的高质量证据来支持或劝阻心脏手术中系统性使用左西孟旦。
