Levosimendan in patients undergoing extracorporeal membrane oxygenation after cardiac surgery: an emulated target trial using observational data

Abstract Background Retrospective 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. Methods All patients with refract...

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Main Authors: 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, Adrien Bouglé
Format: Article
Language:English
Published: BMC 2023-02-01
Series:Critical Care
Online Access:https://doi.org/10.1186/s13054-023-04328-6
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author 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
Adrien Bouglé
author_facet 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
Adrien Bouglé
author_sort Julien Massol
collection DOAJ
description Abstract Background Retrospective 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. Methods All 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. Results Two 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). Conclusions Using 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.
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spelling doaj.art-a04e5bd3480f4744abd5b342632feb9c2023-02-12T12:13:36ZengBMCCritical Care1364-85352023-02-0127111310.1186/s13054-023-04328-6Levosimendan in patients undergoing extracorporeal membrane oxygenation after cardiac surgery: an emulated target trial using observational dataJulien Massol0Noémie Simon-Tillaux1Joanna Tohme2Geoffroy Hariri3Pauline Dureau4Baptiste Duceau5Lisa Belin6David Hajage7Yann De Rycke8Ahmed Charfeddine9Guillaume Lebreton10Alain Combes11Adrien Bouglé12Department of Anesthesiology and Critical Care Medicine, La Pitié-Salpêtrière University HospitalDepartment of Anesthesiology and Critical Care Medicine, La Pitié-Salpêtrière University HospitalDepartment of Anesthesiology and Critical Care Medicine, La Pitié-Salpêtrière University HospitalDepartment of Anesthesiology and Critical Care Medicine, La Pitié-Salpêtrière University HospitalDepartment of Anesthesiology and Critical Care Medicine, La Pitié-Salpêtrière University HospitalDepartment of Anesthesiology and Critical Care Medicine, La Pitié-Salpêtrière University HospitalDepartment of Anesthesiology and Critical Care Medicine, La Pitié-Salpêtrière University HospitalDepartment of Anesthesiology and Critical Care Medicine, La Pitié-Salpêtrière University HospitalDepartment of Anesthesiology and Critical Care Medicine, La Pitié-Salpêtrière University HospitalDepartment of Anesthesiology and Critical Care Medicine, La Pitié-Salpêtrière University HospitalDepartment of Anesthesiology and Critical Care Medicine, La Pitié-Salpêtrière University HospitalDepartment of Anesthesiology and Critical Care Medicine, La Pitié-Salpêtrière University HospitalDepartment of Anesthesiology and Critical Care Medicine, La Pitié-Salpêtrière University HospitalAbstract Background Retrospective 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. Methods All 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. Results Two 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). Conclusions Using 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.https://doi.org/10.1186/s13054-023-04328-6
spellingShingle 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
Adrien Bouglé
Levosimendan in patients undergoing extracorporeal membrane oxygenation after cardiac surgery: an emulated target trial using observational data
Critical Care
title Levosimendan in patients undergoing extracorporeal membrane oxygenation after cardiac surgery: an emulated target trial using observational data
title_full Levosimendan in patients undergoing extracorporeal membrane oxygenation after cardiac surgery: an emulated target trial using observational data
title_fullStr Levosimendan in patients undergoing extracorporeal membrane oxygenation after cardiac surgery: an emulated target trial using observational data
title_full_unstemmed Levosimendan in patients undergoing extracorporeal membrane oxygenation after cardiac surgery: an emulated target trial using observational data
title_short Levosimendan in patients undergoing extracorporeal membrane oxygenation after cardiac surgery: an emulated target trial using observational data
title_sort levosimendan in patients undergoing extracorporeal membrane oxygenation after cardiac surgery an emulated target trial using observational data
url https://doi.org/10.1186/s13054-023-04328-6
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