Department of Anesthesia and Critical Care, University Hospital of Dijon, Dijon, France.
Direction of Clinical Research, University Hospital of Dijon, Dijon, France.
ESC Heart Fail. 2021 Aug;8(4):3339-3347. doi: 10.1002/ehf2.13427. Epub 2021 Jun 18.
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.
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.
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.
静脉-动脉体外膜肺氧合（VA-ECMO）越来越多地用于循环衰竭。主要适应证为心源性休克、心脏手术后心功能衰竭和难治性心脏骤停。然而，VA-ECMO 脱机特别具有挑战性，据报道脱机失败率高达 50%，相关死亡率增加。左西孟旦是一种新型长效作用的正性肌力药和血管扩张剂，用于心源性休克和终末期心力衰竭失代偿。左西孟旦在 VA-ECMO 患者中的应用似乎可以降低脱机失败率，无论最初的病因如何，并在 VA-ECMO 启动后早期给药时降低死亡率。然而，这些研究仅限于回顾性分析和报道的病例系列。WEANILEVO 试验的目的是评估在 VA-ECMO 脱机前给予左西孟旦是否与降低脱机失败率和需要其他临时循环支持相关。
WEANILEVO 是一项随机、前瞻性、多中心、双盲、平行组、对照试验。如果 180 名接受 VA-ECMO 治疗的急性循环性心力衰竭患者预计在 48 小时内进行脱机，将招募这些患者。研究药物为左西孟旦（0.2μg/kg/min，持续 24 小时）或安慰剂。试验的主要终点是在 VA-ECMO 脱机后 7 天内无 VA-ECMO 脱机、需要再次 VA-ECMO 或其他临时循环辅助或死亡。
左西孟旦在 VA-ECMO 中的应用似乎有利于降低脱机失败率和死亡率。WEANILEVO 的结果将显著影响关于使用左西孟旦进行 VA-ECMO 脱机的决策。
