Department of Internal Medicine, Division of Cardiology, Chonnam National University Medical School, Chonnam National University Hospital, Gwangju, South Korea.
Department of Emergency Medicine, Chonnam National University Medical School, Chonnam National University Hospital, Gwangju, South Korea.
ESC Heart Fail. 2023 Aug;10(4):2672-2679. doi: 10.1002/ehf2.14450. Epub 2023 Jul 6.
The clinical benefits of venoarterial extracorporeal membrane oxygenation (VA-ECMO) for profound cardiogenic shock are well known. However, peripheral VA-ECMO increases the left ventricular afterload, thus compromising myocardial recovery. Recent studies have revealed the benefit of left ventricular unloading using various methods applied at different times. The EARLY-UNLOAD trial compares the clinical outcomes of early left ventricular unloading and conventional approach after VA-ECMO.
The EARLY-UNLOAD trial is a single-centre, open-label, randomized trial that recruited 116 patients with cardiogenic shock undergoing VA-ECMO. Patients meeting the inclusion criteria were randomized in a 1:1 ratio to two groups: routine left ventricular unloading via intracardiac echocardiography-guided transseptal left atrial cannulation within 12 h of VA-ECMO initiation or conventional approach that indicates rescue left ventricular unloading if clinical signs of an increased left ventricular afterload are present. The primary endpoint is the cumulative incidence of all-cause death within 30 days, and patients will be followed-up for 12 months. A key secondary endpoint is a composite measure of all-cause death and rescue transseptal left atrial cannulation in the conventional group (suggestive of VA-ECMO treatment failure) within 30 days. The enrolment of patients was finished in September 2022.
The EARLY-UNLOAD trial is the first randomized controlled trial to compare early left ventricular unloading and conventional approach after VA-ECMO using the same unloading modality. The results could impact clinical practice to overcome the haemodynamic issues associated with VA-ECMO.
众所周知，静脉-动脉体外膜肺氧合（VA-ECMO）在心源性休克中的临床益处。然而，外周 VA-ECMO 增加了左心室后负荷，从而影响心肌恢复。最近的研究揭示了使用不同方法在不同时间施加的左心室卸载的益处。EARLY-UNLOAD 试验比较了 VA-ECMO 后早期左心室卸载和常规方法的临床结果。
EARLY-UNLOAD 试验是一项单中心、开放标签、随机试验，招募了 116 名接受 VA-ECMO 的心源性休克患者。符合纳入标准的患者以 1:1 的比例随机分为两组：VA-ECMO 启动后 12 小时内通过心内超声引导下经房间隔左心房穿刺进行常规左心室卸载或常规方法，如果存在左心室后负荷增加的临床迹象，则指示进行左心室卸载。主要终点是 30 天内全因死亡的累积发生率，患者将随访 12 个月。一个关键的次要终点是 30 天内常规组全因死亡和经房间隔左心房穿刺的复合指标（提示 VA-ECMO 治疗失败）。患者的招募已于 2022 年 9 月完成。
EARLY-UNLOAD 试验是第一项比较 VA-ECMO 后早期左心室卸载和常规方法的随机对照试验，使用相同的卸载方式。结果可能会影响临床实践，以克服与 VA-ECMO 相关的血液动力学问题。
