美国明尼苏达大学医学院Demetris Yannopoulos团队研究了院外心脏骤停及难治性心室纤颤患者的先进再灌注策略的效果。2020年11月13日，该研究发表在《柳叶刀》杂志上。

在院外心脏骤停（OHCA）和心室纤颤的患者中，超过一半的患者出现难治性心室纤颤，对初始标准晚期心脏生命支持（ACLS）治疗无反应。研究组在美国首次对OHCA和难治性心室纤颤患者进行了体外膜氧合（ECMO）促进复苏与标准ACLS治疗的随机临床试验。

在这项临床2期、单中心、开放标签、适应性、安全性和有效性的随机临床试验中，研究组招募了18-75岁、转运到明尼苏达大学医学中心、OHCA和难治性心室纤颤的患者，三次电击后自发循环无恢复，采用隆德大学心脏骤停系统自动心肺复苏，估计转移时间小于30分钟。根据安全时间表，患者被随机分配接受早期ECMO促进复苏或标准ACLS治疗。主要结局是出院生存。次要结局是出院时以及出院后3个月和6个月的安全性、生存率和功能评估。

2019年8月8日至2020年6月14日，研究组共纳入36名患者。排除6名患者后，将余下30名随机分组，其中15名接受标准ACLS治疗，15名接受早期ECMO促进复苏。ECMO促进复苏组中有1名患者出院前退出研究。30名患者的平均年龄为59岁，25名（83％）为男性。

标准ACLS治疗组15名患者中有1名（7％）存活出院，而早期ECMO促进复苏组14名患者中有6名（43％），组间差异显著。由于ECMO优越性的后验概率超出了预定的监测范围，在招募了30名患者后，该研究在中期分析时终止。早期ECMO组的6个月累计生存率明显优于标准ACLS组。未观察到意外的严重不良事件。

研究结果表明，与标准ACLS治疗相比，早期ECMO促进复苏治疗OHCA和难治性心室纤颤患者可显著提高出院生存率。

附：英文原文

Title: Advanced reperfusion strategies for patients with out-of-hospital cardiac arrest and refractory ventricular fibrillation (ARREST): a phase 2, single centre, open-label, randomised controlled trial

Author: Demetris Yannopoulos, Jason Bartos, Ganesh Raveendran, Emily Walser, John Connett, Thomas A Murray, Gary Collins, Lin Zhang, Rajat Kalra, Marinos Kosmopoulos, Ranjit John, Andrew Shaffer, R J Frascone, Keith Wesley, Marc Conterato, Michelle Biros, Jakub Tolar, Tom P Aufderheide

Issue&Volume: 2020-11-13

Abstract:

Background

Among patients with out-of-hospital cardiac arrest (OHCA) and ventricular fibrillation, more than half present with refractory ventricular fibrillation unresponsive to initial standard advanced cardiac life support (ACLS) treatment. We did the first randomised clinical trial in the USA of extracorporeal membrane oxygenation (ECMO)-facilitated resuscitation versus standard ACLS treatment in patients with OHCA and refractory ventricular fibrillation.

Methods

For this phase 2, single centre, open-label, adaptive, safety and efficacy randomised clinical trial, we included adults aged 18–75 years presenting to the University of Minnesota Medical Center (MN, USA) with OHCA and refractory ventricular fibrillation, no return of spontaneous circulation after three shocks, automated cardiopulmonary resuscitation with a Lund University Cardiac Arrest System, and estimated transfer time shorter than 30 min. Patients were randomly assigned to early ECMO-facilitated resuscitation or standard ACLS treatment on hospital arrival by use of a secure schedule generated with permuted blocks of randomly varying block sizes. Allocation concealment was achieved by use of a randomisation schedule that required scratching off an opaque layer to reveal assignment. The primary outcome was survival to hospital discharge. Secondary outcomes were safety, survival, and functional assessment at hospital discharge and at 3 months and 6 months after discharge. All analyses were done on an intention-to-treat basis. The study qualified for exception from informed consent (21 Code of Federal Regulations 50.24). The ARREST trial is registered with ClinicalTrials.gov, NCT03880565.

Findings

Between Aug 8, 2019, and June 14, 2020, 36 patients were assessed for inclusion. After exclusion of six patients, 30 were randomly assigned to standard ACLS treatment (n=15) or to early ECMO-facilitated resuscitation (n=15). One patient in the ECMO-facilitated resuscitation group withdrew from the study before discharge. The mean age was 59 years (range 36–73), and 25 (83%) of 30 patients were men. Survival to hospital discharge was observed in one (7%) of 15 patients (95% credible interval 1·6–30·2) in the standard ACLS treatment group versus six (43%) of 14 patients (21·3–67·7) in the early ECMO-facilitated resuscitation group (risk difference 36·2%, 3·7–59·2; posterior probability of ECMO superiority 0·9861). The study was terminated at the first preplanned interim analysis by the National Heart, Lung, and Blood Institute after unanimous recommendation from the Data Safety Monitoring Board after enrolling 30 patients because the posterior probability of ECMO superiority exceeded the prespecified monitoring boundary. Cumulative 6-month survival was significantly better in the early ECMO group than in the standard ACLS group. No unanticipated serious adverse events were observed.

Interpretation

Early ECMO-facilitated resuscitation for patients with OHCA and refractory ventricular fibrillation significantly improved survival to hospital discharge compared with standard ACLS treatment.

DOI: 10.1016/S0140-6736(20)32338-2

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32338-2/fulltext