Abstract
We sought to synthesize the available evidence regarding safety and efficacy of intermittent levosimendan (LEVO) infusions in ambulatory patients with end-stage heart failure (HF). Safety and efficacy of ambulatory intermittent LEVO infusion in patients with end-stage HF are yet not established. We systematically searched MEDLINE, EMBASE, SCOPUS, Web of Science, and Cochrane databases, from inception to January 30, 2021 for studies reporting outcome of adult ambulatory patients with end-stage HF treated with intermittent LEVO infusion. Fifteen studies (8 randomized and 7 observational) comprised 984 patients (LEVO [N = 727] and controls [N = 257]) met the inclusion criteria. LEVO was associated with improved New York Heart Association (NYHA) functional class (weighted mean difference [WMD] −1.04, 95%CI: −1.70 to −0.38, p < 0.001, 5 studies, I2 = 93%), improved left ventricular (LV) ejection fraction (WMD 4.0%, 95%CI: 2.8% to 5.3%, p < 0.001, 6 studies, I2 = 9%), and reduced BNP levels (WMD −549 pg/mL, 95%CI −866 to −233, p < 0001, 3 studies, I2 = 66%). All-cause death was not different (RR 0.65, 95%CI: 0.38 to 1.093, p = 0.10, 6 studies, I2 = 0), but cardiovascular death was lower on LEVO (RR 0.34, 95%CI: 0.13 to 0.87, p = 0.02, 3 studies, I2 = 0) compared to controls. Furthermore, health-related quality of life (HRQoL) was improved alongside with reduced LV size following LEVO infusions. Major adverse events were not different between LEVO and placebo. In conclusion, intermittent LEVO infusions in ambulatory patients with end-stage HF is associated with less frequent cardiovascular death alongside with improved NYHA class, quality of life, BNP levels, and LV function. However, the current evidence is limited by heterogeneous and relatively small studies.
Highlights
Chronic heart failure (HF) is a major cause of recurrent hospitalizations and mortality
In countries with extreme long waiting for a donor heart, it may be used as a bridge-totransplantation if an left ventricular assist device implantation (LVAD) implantation is not feasible or not available [4]
Random-effect model meta-analysis of 5 out of 8 studies [8, 13, 16, 18, 20] showed New York Heart Association (NYHA) class improvement following LEVO use compared to before use, with a weighted mean difference (WMD) of −1.04 (95%CI: −1.6 to −0.4, p < 0.001)
Summary
Chronic heart failure (HF) is a major cause of recurrent hospitalizations and mortality. In countries with extreme long waiting for a donor heart, it may be used as a bridge-totransplantation if an LVAD implantation is not feasible or not available [4]. This inotropic support includes dopamine, dobutamine, milrinone, enoximone, and in some countries levosimendan (LEVO). Repetitive and continuous administration of conventional inotropes such as milrinone and dobutamine could provide hemodynamic relief in patients with end-stage HF and is associated with symptomatic improvements. In contrast to conventional inotropes, LEVO is a new inotropic agent that acts as a calcium sensitizer It sensitizes troponin C without increasing intracellular calcium concentration or exacerbating ischemia, and as an inodilator, it reduces the cardiac pre-, and afterload. We conducted a systematic review and meta-analysis of the current literature to synthesize evidence regarding exploring the efficacy and the safety of LEVO on different outcomes in ambulatory end-stage HF patients receiving intermittent LEVO infusions
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