Protocol of repeated outpatient infusions of levosimendan in elderly patients with advanced heart failure: preliminary data from a real-world experience

Abstract Background Intermittent infusions of Levosimendan (L) have been shown to reduce hospitalizations and improve quality of life in patients with advanced heart failure (HF). "Real–world" experience is currently insufficient, particularly in older patients. Purpose: Since November 2020 we treated elderly outpatients with advanced HF with repeated L infusions. Here, we present the preliminary analysis of the collected data. Methods The protocol involves three infusions of L given 14 days apart. The duration of each session was approximately 8 hours. The starting infusion rate is 0.05 μg/Kg/min, titrated every 30/60‘ to a maximum of 0.2 μg/Kg/min based on blood pressure, heart rate and rhythm recorded on telemetry. We evaluated patients by clinical, labatorily and echocardiographic at baseline and two weeks after the end of treatment. Results The treated population had a mean age of 79 years, a long history of disease (mean 12 years) and high comorbidities (mean Charlson Comorbidity Index of 6.8). As shown in Table 1, we compared our population with that of leading international trials on this type of treatment, and we found that our population was significantly older and more complex. Of the 19 patients enrolled, 15 completed the expected treatment of infusions while 4 were lost due to hospitalizations for cardiovascular causes and/or social issues. In the 50 infusions performed, we observed good tolerance to the therapy with a failure rate of 2 % and good safety profile in the absence of major adverse effects, particularly in terms of arrhythmias (Figure 1). At the end of the infusion cycles, there was significant improvement of clinical and hemodynamic parameters (Figure 2). Moreover, we found a decrease in systemic congestion in terms of VD–AD gradient reduction (p=0.031) associated with a downward trend in average daily furosemide dose, clinical congestion scores and mean NTproBNP value. Conclusions Our preliminary analysis seems to confirm the safety and tolerability of the developed treatment scheme. Further data are needed to confirm its efficacy in clinical, hemodynamic, and therapy effects.