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. 2023 Aug 8;13(1):69.
doi: 10.1186/s13613-023-01164-3.

Overview of the current use of levosimendan in France: a prospective observational cohort study

Bernard Cholley  1   2 , Mirela Bojan  3 , Benoit Guillon  4 , Emmanuel Besnier  5 , Mathieu Mattei  6 , Bruno Levy  7 , Alexandre Ouattara  8   9 , Nadir Tafer  8   9 , Clément Delmas  10 , David Tonon  11 , Bertrand Rozec  12 , Jean-Luc Fellahi  13 , Pascal Lim  14 , François Labaste  15 , François Roubille  16 , Thibaut Caruba  17 , Philippe Mauriat  8 ; ARCOTHOVA study group
Collaborators, Affiliations

Overview of the current use of levosimendan in France: a prospective observational cohort study

Bernard Cholley et al. Ann Intensive Care. .

Erratum in

Abstract

Background: Following the results of randomized controlled trials on levosimendan, French health authorities requested an update of the current use and side-effects of this medication on a national scale.

Method: The France-LEVO registry was a prospective observational cohort study reflecting the indications, dosing regimens, and side-effects of levosimendan, as well as patient outcomes over a year.

Results: The patients included (n = 602) represented 29.6% of the national yearly use of levosimendan in France. They were treated for cardiogenic shock (n = 250, 41.5%), decompensated heart failure (n = 127, 21.1%), cardiac surgery-related low cardiac output prophylaxis and/or treatment (n = 86, 14.3%), and weaning from veno-arterial extracorporeal membrane oxygenation (n = 82, 13.6%). They received 0.18 ± 0.07 µg/kg/min levosimendan over 26 ± 8 h. An initial bolus was administered in 45 patients (7.5%), 103 (17.1%) received repeated infusions, and 461 (76.6%) received inotropes and or vasoactive agents concomitantly. Hypotension was reported in 218 patients (36.2%), atrial fibrillation in 85 (14.1%), and serious adverse events in 17 (2.8%). 136 patients (22.6%) died in hospital, and 26 (4.3%) during the 90-day follow-up.

Conclusions: We observed that levosimendan was used in accordance with recent recommendations by French physicians. Hypotension and atrial fibrillation remained the most frequent side-effects, while serious adverse event potentially attributable to levosimendan were infrequent. The results suggest that this medication was safe and potentially associated with some benefit in the population studied.

Keywords: Cardiogenic shock; Heart failure; Inotropes; Levosimendan; Repetitive infusions; VA-ECMO weaning.

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Conflict of interest statement

Bernard Cholley, Bruno Levy, Alexandre Ouattara, Jean-Luc Fellahi, and Thibaut Caruba are part of an advisory board for Orion Pharma in charge of designing and coordinating the FRANCE LEVO registry, at the request of the French Haute Autorité de Santé. Philippe Mauriat is a consultant for Orion Pharma.

Figures

Fig. 1
Fig. 1
Repeated levosimendan infusions. Among “others”, 25 patients were admitted to hospital for a planned repeated infusion in the context of chronic heart failure
Fig. 2
Fig. 2
Use of inotropic agents during the week before and the week after levosimendan initiation. Day 0 corresponds to the initiation of levosimendan infusion
Fig. 3
Fig. 3
Variations in Vasoactive Inotropic Score approximation during the week before and the week after levosimendan initiation. Day 0 corresponds to the initiation of levosimendan infusion
Fig. 4
Fig. 4
Relation between the delay to levosimendan treatment with respect to ICU admission and the duration of ICU/hospital stay. Analyses were adjusted for the variables shown in Table 4
See this image and copyright information in PMC

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