Efficacy of levosimenden in pediatric patients with congenital heart disease: a systematic review and meta-analysis

Background: Levosimenden (LS) increasingly has been used in children with congenital heart disease (CHD) with limited evidence for its use. This study aimed to investigate the efficacy of LS in children with CHD. Methods: We conducted a systematic search of randomized controlled trials (RCT) using various search engines, according to PRISMA guidelines. All RCTs involving LS with possible outcomes for assessing the efficacy on various physiological parameters, especially with mean arterial pressure (MAP), heart rate (HR), and lactate levels were included. Results: Of 435 screened studies, 11 studies were included, encompassing a collective cohort of 345 CHD patients for control and 332 CHD patients for intervention who received LS. The pooled mean difference for the MAP among children who had LS was -0.99 (95%CI: -4.09, 2.11). (Heterogeneity I2 67%; p 0.009). Similarly, the HR and mean arterial lactate (MAL) were -2.95 (95%CI: -7.61, 1.71) and 0.02 (95%CI: -0.50, 0.54). Subgroup analysis with the LS with Milrionone and other agents for MAP, HR, and MAL was done and found that LS favors over the Milrionone when compared with other agents. 45% of the included studies exhibited a high ROB. Conclusion: Our findings emphasize improvement in MAP and HR with LS. Notably, subgroup analysis showed a favorable effect of LS compared to milrinone and other agents, particularly concerning MAP. These findings highlight the need for further robust investigations into the role of LS for pediatrics with CHD.