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Randomized Controlled Trial Observational Study
Levosimendan in patients undergoing extracorporeal membrane oxygenation after cardiac surgery: an emulated target trial using observational data.
- Julien Massol, Noémie Simon-Tillaux, Joanna Tohme, Geoffroy Hariri, Pauline Dureau, Baptiste Duceau, Lisa Belin, David Hajage, Yann De Rycke, Ahmed Charfeddine, Guillaume Lebreton, Alain Combes, and Adrien Bouglé.
- Department of Anesthesiology and Critical Care Medicine, La Pitié-Salpêtrière University Hospital, 47-83 Boulevard de L'Hôpital, 75013, Paris, France.
- Crit Care. 2023 Feb 7; 27 (1): 5151.
BackgroundRetrospective cohorts have suggested that levosimendan may facilitate the weaning of veno-arterial extracorporeal membrane oxygenation (VA-ECMO). We therefore studied this clinical question by emulating a randomized trial with observational data.MethodsAll patients with refractory postcardiotomy cardiogenic shock and assisted with VA-ECMO, admitted to a surgical intensive care unit at La Pitié-Salpêtrière Hospital between 2016 and 2019, were eligible. To avoid immortal-time bias, we emulated a target trial sequentially comparing levosimendan administration versus no levosimendan administration in patients treated with VA-ECMO. The primary outcome was time to successful ECMO weaning. The secondary outcomes were 30-day and 1-year mortality. We performed a multivariable analysis to adjust for confounding at baseline.ResultsTwo hundred and thirty-nine patients were included in the study allowing building a nested trials cohort of 1434 copies of patients. No association of levosimendan treatment and VA-ECMO weaning was found (HR = 0.91, [0.57; 1.45], p = 0.659 in multivariable analysis), or 30-day mortality (OR = 1.03, [0.52; 2.03], p = 0.940) and 1-year mortality (OR = 1.00, [0.53; 1.89], p = 0.999).ConclusionsUsing the emulated target trial framework, this study did not find any association of levosimendan treatment and ECMO weaning success after postcardiotomy cardiogenic shock. However, the population of interest remains heterogeneous and subgroups might benefit from levosimendan.© 2023. The Author(s).
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