Abstract
Background Recent studies suggest that levosimendan does not provide mortality benefit in patients with low cardiac output syndrome undergoing cardiac surgery. These results conflict with previous findings. The aim of the current study is to assess whether levosimendan reduces postoperative mortality in patients with impaired left ventricular function (mean EF ≤ 40%) undergoing cardiac surgery. Methods We conducted a comprehensive search of PubMed, EMBASE, and Cochrane Library Database through November 20, 2017. Inclusion criteria were random allocation to treatment with at least one group receiving levosimendan and another group receiving placebo or other treatments and cardiac surgery patients with a left ventricular ejection fraction of 40% or less. The primary endpoint was postoperative mortality. Secondary outcomes were cardiac index, pulmonary capillary wedge pressure (PCWP), length of intensive care unit (ICU) stay, postoperative atrial fibrillation, and postoperative renal replacement therapy. We performed trial sequential analysis (TSA) to evaluate the reliability of the primary endpoint. Results Data from 2,152 patients in 15 randomized clinical trials were analyzed. Pooled results demonstrated a reduction in postoperative mortality in the levosimendan group [RR = 0.53, 95% CI (0.38–0.73), I2 = 0]. However, the result of TSA showed that the conclusion may be a false positive. Secondary outcomes demonstrated that PCWP, postoperative renal replacement therapy, and length of ICU stay were significantly reduced. Cardiac index was greater in the levosimendan group. No difference was found in the rate of postoperative atrial fibrillation. Conclusions Levosimendan reduces the rate of death and other adverse outcomes in patients with low ejection fraction who were undergoing cardiac surgery, but results remain inconclusive. More large-volume randomized clinical trials (RCTs) are warranted.
Highlights
Cardiac surgery is a common operation, with more than 1 million procedures performed annually in the United States and Europe [1]
Seven studies [10, 11, 18, 32, 34, 35, 37] taking bolus and 24-hour prolonged infusion of levosimendan suggested that there was a significant reduction in the risk of postoperative mortality in the levosimendan group (RR = 0.48 [95% confidence intervals (CIs): 0.32, 0.73], p for effect = 0.0004)
The subgroup analysis by type of cardiac surgery suggested that both coronary surgery and other surgical types in this analysis could lower the mortality in the levosimendan group (RR = 0.56 [95% CI: 0.35, 0.90], p for effect = 0.02 and relative risk (RR) = 0.50 [95% CI: 0.32, 0.78], p for effect = 0.002)
Summary
Cardiac surgery is a common operation, with more than 1 million procedures performed annually in the United States and Europe [1]. Postoperative risk of mortality remains high, especially in patients with postoperative low cardiac output syndrome. Preoperative left ventricular dysfunction is an independent risk factor for mortality and is associated with postoperative low cardiac output syndrome [2]. Recent studies suggest that levosimendan does not provide mortality benefit in patients with low cardiac output syndrome undergoing cardiac surgery. The aim of the current study is to assess whether levosimendan reduces postoperative mortality in patients with impaired left ventricular function (mean EF ≤ 40%) undergoing cardiac surgery. Levosimendan reduces the rate of death and other adverse outcomes in patients with low ejection fraction who were undergoing cardiac surgery, but results remain inconclusive.
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