Abstract
Patients with left ventricular dysfunction (LVD) undergoing cardiac surgery have a high mortality rate. Levosimendan, a calcium sensitizer, improves myocardial contractility without increasing myocardial oxygen demand. It is not clear whether levosimendan can reduce mortality in cardiac surgery patients with LVD. The PubMed, Embase, and Cochrane Central databases were searched to identify randomized trials comparing levosimendan with conventional treatment in cardiac surgery patients with LVD. We derived pooled risk ratios (RRs) with random effects models. The primary endpoint was perioperative mortality. Secondary endpoints were renal replacement treatment, atrial fibrillation, myocardial infarction, ventricular arrhythmia, and hypotension. Fifteen studies enrolling 2606 patients were included. Levosimendan reduced the incidence of perioperative mortality (RR: 0.64, 95%CI: 0.45–0.91) and renal replacement treatment (RR:0.71, 95%CI:0.52–0.95). However, sensitivity analysis, subgroup analysis and Trial Sequential Analysis (TSA) indicated that more evidence was needed. Furthermore, levosimendan did not reduce the incidence of atrial fibrillation (RR:0.82, 95%CI:0.64–1.07), myocardial infarction (RR:0.56, 95%CI:0.26–1.23), or ventricular arrhythmia (RR:0.74, 95%CI:0.49–1.11), but it increased the incidence of hypotension (RR:1.11,95%CI:1.00–1.23). There was not enough high-quality evidence to either support or contraindicate the use of levosimendan in cardiac surgery patients with LVD.
Highlights
More than 1 million patients undergo cardiac surgery with cardiopulmonary bypass (CPB) in the United States and Europe every year[1]
Our analysis showed that use of levosimendan in patients with left ventricular dysfunction (LVD) undergoing cardiac surgery was associated with a significant reduction in perioperative mortality (RR: 0.64, 95%confidence intervals (CI):0.45– 0.91, P = 0.01, I2 = 15%) (Fig. 2)
Renal-replacement therapy was lower in the levosimendan group in random effects (RR:0.71, 95%CI:0.52–0.95, P = 0.01, I2 = 0%) (Supplementary Fig. 2)
Summary
Sensitivity analyses were performed by excluding individual trials one at a time and recalculating the pooled RR estimation for the remaining studies, which indicated that both Levin[29] and Levin[13] could influence the overall effect (Table 2). In this way, the results of sensitivity analysis and TSA showed that this result is not solid. We performed sensitivity analyses and found Levin[29], Levin[13], Baysal[25], and Mehta[17] all affected the overall effect (Supplementary Table 1) All of this evidence indicated that there was not enough evidence to support the idea that levosimendan could reduce renal-replacement therapy.
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