Effect of Intra-arrest Transport, Extracorporeal Cardiopulmonary Resuscitation, and Immediate Invasive Assessment and Treatment on Functional Neurologic Outcome in Refractory Out-of-Hospital Cardiac Arrest A Randomized Clinical Trial
Effect of Intra-arrest Transport, Extracorporeal Cardiopulmonary Resuscitation, and Immediate Invasive Assessment and Treatment on Functional Neurologic Outcome in Refractory Out-of-Hospital Cardiac Arrest A Randomized Clinical Trial
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DOI：
10.1001/jama.2022.1025
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发表时间：
2022-02-22
影响因子：
120.7
通讯作者：
Linhart, Ales
中科院分区：
文献类型：
--
作者：
Belohlavek, Jan;Smalcova, Jana;Linhart, Ales
院外心脏骤停（OHCA）预后不良。在这种情况下，停搏内转运、体外心肺复苏（ECPR）和立即有创评估和治疗（有创策略）是否有益仍不确定。目的：探讨成人难治性OHCA的早期有创入路是否能改善神经学上有利的生存率。设计、环境和参与者在捷克共和国布拉格进行的一项单中心随机临床试验，研究对象为被证实为心脏源性OHCA的成人，无自然循环恢复。在2013年3月至2020年10月期间，共招募了256名参与者，计划样本量为285人。观察患者直至死亡或第180天（最后一次患者随访于2021年3月30日结束）。干预措施在有创策略组（n = 124），开始机械压迫，随后骤停内转运到心脏中心进行ECPR，并立即进行有创评估和治疗。标准策略组（n = 132）在现场继续进行常规高级心脏生命支持。主要结局和测量主要结局是随机分组后180天神经系统预后良好（定义为脑功能类别[CPC] 1-2）的生存。次要结局包括30天的神经系统恢复（定义为前30天内任何时间的CPC 1-2）和30天的心脏恢复（定义为至少24小时不需要药物或机械心脏支持）。结果：在数据和安全监测委员会的建议下，当达到预定的无效标准时，试验停止。256例患者（中位年龄58岁，女性44例[17%]）中，256例（100%）完成了试验。主分析中，有创策略组39例（31.5%）患者存活至180天，标准策略组29例（22.0%）患者存活至180天，神经系统预后良好（优势比[OR] 1.63 [95% CI, 0.93 ~ 2.85]；差异为9.5% [95% CI, -1.3% ~ 20.1%]; P = 0.09）。30天，有创策略组有38例（30.6%）患者神经功能恢复，标准策略组有24例（18.2%）患者神经功能恢复（OR, 1.99 [95% CI, 1.11 ~ 3.57]；差异，12.4% [95% CI, 1.9% ~ 22.7%]; P = 0.02），分别有54例（43.5%）和45例（34.1%）患者心脏功能恢复（OR, 1.49 [95% CI, 0.91 ~ 2.47]；差异，9.4% [95% CI, -2.5% ~ 21%]; P = 0.12）。有创策略组出血发生率高于标准策略组（分别为31%和15%）。在难治性院外心脏骤停患者中，与标准复苏相比，早期停搏内转运、ECPR和有创性评估和治疗并没有显著提高180天的生存率和神经系统有利结果。然而，该试验可能不足以发现临床相关的差异。
IMPORTANCE Out-of-hospital cardiac arrest (OHCA) has poor outcome. Whether intra-arrest transport, extracorporeal cardiopulmonary resuscitation (ECPR), and immediate invasive assessment and treatment (invasive strategy) is beneficial in this setting remains uncertain.OBJECTIVE To determine whether an early invasive approach in adults with refractory OHCA improves neurologically favorable survival.DESIGN, SETTING, AND PARTICIPANTS Single-center, randomized clinical trial in Prague, Czech Republic, of adults with a witnessed OHCA of presumed cardiac origin without return of spontaneous circulation. A total of 256 participants, of a planned sample size of 285, were enrolled between March 2013 and October 2020. Patients were observed until death or day 180 (last patient follow-up ended on March 30, 2021).INTERVENTIONS In the invasive strategy group (n = 124), mechanical compression was initiated, followed by intra-arrest transport to a cardiac center for ECPR and immediate invasive assessment and treatment. Regular advanced cardiac life support was continued on-site in the standard strategy group (n = 132).MAIN OUTCOMES AND MEASURES The primary outcome was survival with a good neurologic outcome (defined as Cerebral Performance Category [CPC] 1-2) at 180 days after randomization. Secondary outcomes included neurologic recovery at 30 days (defined as CPC 1-2 at any time within the first 30 days) and cardiac recovery at 30 days (defined as no need for pharmacological or mechanical cardiac support for at least 24 hours).RESULTS The trial was stopped at the recommendation of the data and safety monitoring board when prespecified criteria for futility were met. Among 256 patients (median age, 58 years; 44 [17%] women), 256 (100%) completed the trial. In the main analysis, 39 patients (31.5%) in the invasive strategy group and 29 (22.0%) in the standard strategy group survived to 180 days with good neurologic outcome (odds ratio [OR], 1.63 [95% CI, 0.93 to 2.85]; difference, 9.5% [95% CI, -1.3% to 20.1%]; P = .09). At 30 days, neurologic recovery had occurred in 38 patients (30.6%) in the invasive strategy group and in 24 (18.2%) in the standard strategy group (OR, 1.99 [95% CI, 1.11 to 3.57]; difference, 12.4% [95% CI, 1.9% to 22.7%]; P = .02), and cardiac recovery had occurred in 54 (43.5%) and 45 (34.1%) patients, respectively (OR, 1.49 [95% CI, 0.91 to 2.47]; difference, 9.4% [95% CI, -2.5% to 21%]; P = .12). Bleeding occurred more frequently in the invasive strategy vs standard strategy group (31% vs 15%, respectively).CONCLUSIONS AND RELEVANCE Among patients with refractory out-of-hospital cardiac arrest, the bundle of early intra-arrest transport, ECPR, and invasive assessment and treatment did not significantly improve survival with neurologically favorable outcome at 180 days compared with standard resuscitation. However, the trial was possibly underpowered to detect a clinically relevant difference.