Efficacy of levosimendan therapy in pediatric practice: a systematic review and meta-analysis of randomized controlled trials

Levosimendan is increasingly being used to treat heart failure and cardiac dysfunction in pediatric patients. Currently, there is limited evidence that this drug has a positive effect on treatment outcomes. The aim of the literature review was to investigate the effects of levosimendan on hemodynamic parameters and outcomes in pediatric patients in various clinical settings. The study design was a systematic review of randomized and non-randomized studies. Randomized clinical trials were included in the meta-analysis. The primary outcome of the meta-analysis was the effect of levosimendan on central venous oxygen saturation (ScvO2) and lactate levels as surrogate markers of low cardiac output syndrome. Study participants were pediatric patients (age 18 years) receiving levosimendan compared with any control. Forty-two studies published between 2004 and 2021 were identified, including a total of 1131 pediatric patients. Nine studies (including 547 patients) were RCTs, all conducted in the pediatric cardiac surgery setting. In the RCTs, the use of levosimendan was associated with a significant improvement in ScvO2 (p = 0.03) and a trend toward lower postoperative lactate levels (p = 0.08). No differences in secondary outcomes were found. The use of levosimendan in pediatric patients is not associated with serious side effects and may lead to hemodynamic improvement after cardiac surgery. However, its effect on major clinical outcomes remains to be determined. Overall, the quality of evidence for the use of levosimendan in pediatric patients is low, and further high-quality studies are needed.