The Hemodynamic Effects and Safety of Repetitive Levosimendan Infusions on Children With Dilated Cardiomyopathy.

Abstract

Limited treatment options are available for children with decompensated dilated cardiomyopathy (DCM), while they wait for either functional recovery or heart transplantation. We evaluated the safety of repetitive levosimendan infusions and short-term and long-term impacts of the therapy in this patient population. Eighty-one repetitive levosimendan infusions administered to 20 patients with DCM at severe or end stage of the disease in the pediatric intensive care unit were analyzed retrospectively. Echocardiographic assessments were reinterpreted by two experienced pediatric cardiologists. The mean follow-up time after therapy was 9.8 ± 3.3 years. The median age of the patients at the time of the first levosimendan infusion was 1.1 years (interquartile range: 0.3-2.1). Transient hypotension was reported in 17.3% of the infusions. No significant changes in the mean ejection fraction were detected after repetitive levosimendan infusion (31.6 ± 12.5 vs 33.1 ± 12.4; P = .39) or for the laboratory parameters for the group as a whole. In 7 (35%) of 20 patients, the mean ejection fraction improved from 20% ± 12% to 35% ± 11% ( P = .003). The administration of concomitant medications and time may have contributed to the healing process of these patients. Two patients were removed from the transplantation waiting-list owing to clinical recovery after six months of therapy. The long-term survival rate was 70% (n = 14 of 20). Repetitive levosimendan infusions in children with DCM appeared to be hemodynamically well tolerated without severe adverse events. Although one-third of the children had a good response to repetitive levosimendan infusions, no overall significant improvement in ventricular performance could be found in this heterogenous DCM patient population, which included the patients in end-stage heart failure.