Meta-analysis of the Safety and Efficacy of Levosimendan for Cardiac Insufficiency in Infants and Children.

This meta-analysis aimed to evaluate the safety and efficacy of levosimendan for cardiac insufficiency in infants and children, conducted in accordance with PRISMA guidelines and a PROSPERO-registered protocol. Databases including PubMed, Web of Science, Embase, and the Cochrane Library were searched up to October 6, 2024. A total of 276 initial records were screened, and 16 studies (10 randomized controlled trials and 6 retrospective observational studies) were ultimately included. Meta-analyses using Stata and RevMan revealed that at 6 h post-intervention, levosimendan significantly reduced heart rate (WMD=-7.60, 95% CI [-15.16,-0.04]), mean arterial pressure (WMD=-4.04, 95% CI [-6.5,-1.58]), and lactate levels (SMD=-0.29, 95% CI [-0.58,-0.00]) compared with the control group. However, no significant effects on these three indices were observed at 12 or 24 h. Levosimendan showed no significant impacts on central venous pressure, oxygen saturation, B-type natriuretic peptide, ejection fraction, or length of hospitalization. It also did not increase the risks of acute kidney injury, arrhythmia, mortality, or pneumonia, and no publication bias was detected. In conclusion, levosimendan has a favorable safety profile in this pediatric population. Beneficial effects were observed early, mainly manifested by improvements in hypoxia-related indicators and reductions in heart rate and blood pressure within 6 h, without increasing adverse event risk, and the effects were limited to this early 6-h time point.