Levosimendan in venoarterial ECMO weaning. Rational and design of a randomized double blind multicentre trial

Abstract

Aims: Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is increasingly being used in circulatory failure. The main indications are cardiogenic shock, post-cardiotomy cardiac failure, and refractory cardiac arrest. However, VA-ECMO weaning is particularly challenging, and weaning failure is reported to be as high as 50%, with increased related mortality. Levosimendan is a novel long acting effect inodilator used in cardiogenic shock and terminal heart failure decompensation. Levosimendan use in VA-ECMO patients seems to reduce weaning failure regardless of the initial aetiology and to reduce mortality when administrated early after VA-ECMO initiation. However, studies are limited to retrospective analyses and reported case series. The aim of the WEANILEVO trial is to evaluate whether administration of levosimendan before VA-ECMO weaning is associated with a reduced rates of weaning failure and recourse to other temporary circulatory support.

Methods and results: WEANILEVO is a randomized, prospective, multicentre, double-blind, parallel-group, controlled trial. One hundred eighty patients will be enrolled if they had acute circulatory heart failure treated with VA-ECMO and for whom weaning is expected within 48 h. The study drugs are either levosimendan (0.2 μg/kg/min for 24 h) or a placebo. The primary endpoint of the trial is the absence of VA-ECMO weaning, recourse to another VA-ECMO, or other temporary circulatory assistance or death within 7 days of VA-ECMO weaning.

Conclusions: Levosimendan use in VA-ECMO appears to be beneficial for reducing weaning failure and mortality. The results of WEANILEVO should significantly influence decisions regarding the use of levosimendan for VA-ECMO weaning.

Keywords: ECMO; Heart failure; Levosimendan; Mortality; Weaning.