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Levosimendan for Hemodynamic Support after Cardiac Surgery.

Giovanni Landoni1, Vladimir V Lomivorotov1, Gabriele Alvaro1

  • 1From the Department of Anesthesia and Intensive Care, San Raffaele Scientific Institute (G.L., M.G.C., F.P., F.M., R. Lembo, A.M.S., T.B., A. Belletti, A.Z.), and Vita-Salute San Raffaele University (G.L., A.Z.), Milan, the Department of Anesthesia and Intensive Care, Azienda Ospedaliero-Universitaria Mater Domini Germaneto, Catanzaro (G.A., B.A., M.G.M.), the Department of Anesthesia and Intensive Care, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza (R. Lobreglio, L.B.), the Department of Cardiovascular Anesthesia and Intensive Care, Azienda Ospedaliera Ordine Mauriziano (A. Bianchi), and the Department of Surgical Sciences, University of Turin (L.B.), Turin, the Division of Cardiac Anesthesia and Intensive Care Unit, Azienda Ospedaliera di Rilievo Nazionale dei Colli-Monaldi Hospital, Naples (A.P., L.V.), Division of Cardiothoracic and Vascular Anesthesia and Intensive Care, the Department of Anesthesia and Critical Care Medicine, Azienda Ospedaliero-Universitaria Pisana, Pisa (F.G., P.B.), and the Department of Cardiothoracic and Vascular Anesthesia and Intensive Care, University Hospital Policlinico S. Orsola, Bologna (M.B.) - all in Italy; the Department of Anesthesiology and Intensive Care, State Research Institute of Circulation Pathology, Novosibirsk (V.V. Lomivorotov, V.A.B., M.N.A.), the Department of Anesthesiology and Intensive Care, State Research Institute for Complex Issues of Cardiovascular Disease, Kemerovo (E.V.G., D.L.S.), the Department of Anesthesiology and Intensive Care, Moscow Regional Clinical and Research Institute, Moscow (V.V. Likhvantsev, T.S.Z.), and the Department of Anesthesiology and Intensive Care, Federal Center for Cardiovascular Surgery Astrakhan, Astrakhan (V.V.P.) - all in Russia; Federal University of Juiz de Fora, Juiz de Fora, Brazil (M.F.S.-F.); and the University of Melbourne, Melbourne, VIC, Australia (R.B.).

The New England Journal of Medicine
|March 22, 2017
PubMed
Summary

Low-dose levosimendan did not reduce 30-day mortality in cardiac surgery patients needing hemodynamic support. This randomized trial found no significant difference compared to placebo, indicating it is not effective for this patient group.

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Area of Science:

  • Cardiology
  • Critical Care Medicine
  • Pharmacology

Background:

  • Acute left ventricular dysfunction is a significant complication post-cardiac surgery, linked to higher mortality rates.
  • Previous meta-analyses suggested potential survival benefits of levosimendan in this population.
  • This study aimed to rigorously evaluate levosimendan's efficacy in a large-scale trial.

Purpose of the Study:

  • To determine if levosimendan, when added to standard care, reduces 30-day mortality in patients undergoing cardiac surgery who require perioperative hemodynamic support.
  • To assess the impact of levosimendan on mechanical ventilation duration, ICU stay, and hospital length of stay.

Main Methods:

  • A multicenter, randomized, double-blind, placebo-controlled trial (CHEETAH) was conducted.
  • 506 patients requiring perioperative hemodynamic support post-cardiac surgery were enrolled.
  • Patients received either levosimendan infusion (0.025-0.2 μg/kg/min) or placebo for up to 48 hours, alongside standard care.

Main Results:

  • The trial was halted for futility. No significant difference in 30-day mortality was observed between the levosimendan (12.9%) and placebo (12.8%) groups (P=0.97).
  • There were no significant differences in the duration of mechanical ventilation, ICU stay, or hospital stay between the groups.
  • Rates of hypotension and cardiac arrhythmias were also similar between the levosimendan and placebo arms.

Conclusions:

  • Low-dose levosimendan, as an adjunct to standard care, did not decrease 30-day mortality in patients needing hemodynamic support after cardiac surgery.
  • The findings do not support the use of levosimendan for improving survival in this specific high-risk surgical population.
  • Further research may be needed to explore levosimendan's role in other cardiac conditions or patient subgroups.