Abstract

Advanced heart failure (AdvHF) is associated with high morbidity and mortality. Patients with this clinical condition are potential candidates for heart transplantation or mechanical circulatory support. Initially, however, they are usually supported with inotropic drugs. Recent studies have suggested that levosimendan, independently of hemodynamic improvements, may lead to outcome benefits. To present clinical experiences concerning the indications, effectiveness, tolerance, and safety of levosimendan in the real-life therapy of patients with decompensated AdvHF in 3 cardiac centers in Poland. This is a prospective, observational, three-center study. Forty-nine patients with AdvHF admitted with decompensation were included (88% men, mean age 58 years, 65% ischemic etiology, left ventricular ejection fraction (LVEF) in median 20%) and followed up for an early (3 months) and prolonged period (1 year) after infusion of levosimendan. Patients were analyzed in relation to death. Levosimendan therapy was associated with reduced HF symptoms and signs, New York Heart Association (NYHA) class and level of B-type natriuretic peptide (BNP) at discharge. Five patients died during hospitalization, a further 10 during the three-month follow-up and 3 died during the next nine-month follow-up. During the three-month follow-up, 22 patients were re-hospitalized due to HF and in the next nine-month follow-up 8 were re-hospitalized. A multivariate analysis indicated the QRS duration at discharge (hazard ratio (HR) = 1.02; 95% confidence interval (95% CI) = 1.003-1.03; p = 0.018), high-sensitivity C-reactive protein (hsCRP) (HR = 1.01; 95% CI = 1.004-1.02; p = 0.002), and simultaneous dobutamine infusion (HR = 6.54; 95% CI = 1.4-30.5; p = 0.017) were independent risk factors for death in the one-year follow-up. There were no side effects leading to the interruption of the levosimendan infusion. The use of levosimendan was safe and associated with clinical improvement and reduction in BNP level in AdvHF patients hospitalized due to HF decompensation, although the mortality and re-hospitalization rate during the one-year follow-up remains high.

Highlights

  • Patients with advanced heart failure (AdvHF), which is associated with poor prognosis, comprise an estimated 1% to 10% of the overall heart failure (HF) population and this number is still increasing.[1,2] In acute HF, the estimated in-hospital mortality is 2–17%, a high 30-day mortality of 6.5%, and one-year mortality of up to 45%.3 On the other hand, the implementation of evidence-based therapies in chronic HF, which improved outcomes,[2] showed improvement in the advanced stage of the disease

  • Levosimendan therapy was associated with reduced HF symptoms and signs, New York Heart Association (NYHA) class and level of B-type natriuretic peptide (BNP) at discharge

  • A multivariate analysis indicated the QRS duration at discharge (hazard ratio (HR) = 1.02; 95% confidence interval = 1.003–1.03; p = 0.018), high-sensitivity C-reactive protein (HR = 1.01; 95% cardiac index (CI) = 1.004–1.02; p = 0.002), and simultaneous dobutamine infusion (HR = 6.54; 95% CI = 1.4–30.5; p = 0.017) were independent risk factors for death in the one-year follow-up

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Summary

Introduction

Patients with advanced heart failure (AdvHF), which is associated with poor prognosis, comprise an estimated 1% to 10% of the overall heart failure (HF) population and this number is still increasing.[1,2] In acute HF, the estimated in-hospital mortality is 2–17%, a high 30-day mortality of 6.5%, and one-year mortality of up to 45%.3 On the other hand, the implementation of evidence-based therapies in chronic HF, which improved outcomes,[2] showed improvement in the advanced stage of the disease. Therapy with classical inotropes, such as dobutamine and milrinone, is able to temporary improve hemodynamic and reduce symptoms, but long-term prognosis of patients with AdvHF remains unfavorable.[1,2,4,6]. Additional pharmacological options that improve prognosis are still desirable One such option is levosimendan, a calcium sensitizer. Advanced heart failure (AdvHF) is associated with high morbidity and mortality. Patients with this clinical condition are potential candidates for heart transplantation or mechanical circulatory support. They are usually supported with inotropic drugs. Recent studies have suggested that levosimendan, independently of hemodynamic improvements, may lead to outcome benefits

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