Suverein Martje M, Delnoij Thijs S R, Lorusso Roberto, Brandon Bravo Bruinsma George J, Otterspoor Luuk, Elzo Kraemer Carlos V, Vlaar Alexander P J, van der Heijden Joris J, Scholten Erik, den Uil Corstiaan, Jansen Tim, van den Bogaard Bas, Kuijpers Marijn, Lam Ka Yan, Montero Cabezas José M, Driessen Antoine H G, Rittersma Saskia Z H, Heijnen Bram G, Dos Reis Miranda Dinis, Bleeker Gabe, de Metz Jesse, Hermanides Renicus S, Lopez Matta Jorge, Eberl Susanne, Donker Dirk W, van Thiel Robert J, Akin Sakir, van Meer Oene, Henriques José, Bokhoven Karen C, Mandigers Loes, Bunge Jeroen J H, Bol Martine E, Winkens Bjorn, Essers Brigitte, Weerwind Patrick W, Maessen Jos G, van de Poll Marcel C G
From the Departments of Intensive Care (M.M.S., T.S.R.D., M.E.B., M.C.G.P.), Cardiothoracic Surgery (R.L., P.W.W., J.G.M.), and Clinical Epidemiology and Medical Technical Assessment (B.E.), Maastricht University Medical Center, and the Department of Methodology and Statistics and the Care and Public Health Research Institute (B.W.), the Cardiovascular Research Institute Maastricht (R.L., J.G.M.), and the School for Nutrition and Translational Research in Metabolism (M.C.G.P.), Maastricht University, Maastricht, the Departments of Cardiothoracic Surgery (G.J.B.B.B.), Intensive Care (M.K.), and Cardiology (R.S.H.), Isala Clinics, Zwolle, the Departments of Intensive Care (L.O.) and Cardiothoracic Surgery (K.Y.L.), Catharina Hospital, Eindhoven, the Departments of Intensive Care (C.V.E.K., J.L.M.), Cardiology (J.M.M.C.), and Emergency Medicine (O.M.), Leiden University Medical Center, Leiden, the Departments of Intensive Care (A.P.J.V.), Cardiothoracic Surgery (A.H.G.D.), Anesthesia (S.E.), and Cardiology (J.H.), Amsterdam University Medical Center, and the Department of Intensive Care, Onze Lieve Vrouwe Gasthuis (B.B., J.M.), Amsterdam, the Departments of Intensive Care (J.J.H., D.W.D.) and Cardiology (S.Z.H.R.), University Medical Center Utrecht, Utrecht, the Department of Intensive Care, St. Antonius Hospital, Nieuwegein (E.S., B.G.H.), the Department of Intensive Care, Erasmus Medical Center (C.U., D.D.R.M., R.J.T., K.C.B., L.M., J.J.H.B.), and the Department of Cardiology, Thorax Center, Erasmus University Medical Center (J.J.H.B.), Rotterdam, the Departments of Intensive Care (T.J., S.A.) and Cardiology (G.B.), Haga Hospital, the Hague, and Cardiovascular and Respiratory Physiology Group, TechMed Center, University of Twente, Enschede (D.W.D.) - all in the Netherlands.
N Engl J Med. 2023 Jan 26;388(4):299-309. doi: 10.1056/NEJMoa2204511.
Extracorporeal cardiopulmonary resuscitation (CPR) restores perfusion and oxygenation in a patient who does not have spontaneous circulation. The evidence with regard to the effect of extracorporeal CPR on survival with a favorable neurologic outcome in refractory out-of-hospital cardiac arrest is inconclusive.
In this multicenter, randomized, controlled trial conducted in the Netherlands, we assigned patients with an out-of-hospital cardiac arrest to receive extracorporeal CPR or conventional CPR (standard advanced cardiac life support). Eligible patients were between 18 and 70 years of age, had received bystander CPR, had an initial ventricular arrhythmia, and did not have a return of spontaneous circulation within 15 minutes after CPR had been initiated. The primary outcome was survival with a favorable neurologic outcome, defined as a Cerebral Performance Category score of 1 or 2 (range, 1 to 5, with higher scores indicating more severe disability) at 30 days. Analyses were performed on an intention-to-treat basis.
Of the 160 patients who underwent randomization, 70 were assigned to receive extracorporeal CPR and 64 to receive conventional CPR; 26 patients who did not meet the inclusion criteria at hospital admission were excluded. At 30 days, 14 patients (20%) in the extracorporeal-CPR group were alive with a favorable neurologic outcome, as compared with 10 patients (16%) in the conventional-CPR group (odds ratio, 1.4; 95% confidence interval, 0.5 to 3.5; P = 0.52). The number of serious adverse events per patient was similar in the two groups.
In patients with refractory out-of-hospital cardiac arrest, extracorporeal CPR and conventional CPR had similar effects on survival with a favorable neurologic outcome. (Funded by the Netherlands Organization for Health Research and Development and Maquet Cardiopulmonary [Getinge]; INCEPTION ClinicalTrials.gov number, NCT03101787.).
体外心肺复苏（CPR）可恢复无自主循环患者的灌注和氧合。关于体外心肺复苏对难治性院外心脏骤停患者存活且伴有良好神经功能结局的影响，相关证据尚无定论。
在荷兰进行的这项多中心、随机、对照试验中，我们将院外心脏骤停患者随机分配接受体外心肺复苏或传统心肺复苏（标准高级心血管生命支持）。符合条件的患者年龄在18至70岁之间，接受过旁观者心肺复苏，初始为室性心律失常，且在开始心肺复苏后15分钟内未恢复自主循环。主要结局是存活且伴有良好神经功能结局，定义为30天时脑功能分类评分1或2（范围为1至5，分数越高表明残疾越严重）。分析采用意向性分析。
160例接受随机分组的患者中，70例被分配接受体外心肺复苏，64例接受传统心肺复苏；26例入院时不符合纳入标准的患者被排除。30天时，体外心肺复苏组有14例患者（20%）存活且伴有良好神经功能结局，而传统心肺复苏组为10例患者（16%）（优势比，1.4；95%置信区间，0.5至3.5；P = 0.52）。两组患者的严重不良事件数量相似。
在难治性院外心脏骤停患者中，体外心肺复苏和传统心肺复苏对存活且伴有良好神经功能结局的影响相似。（由荷兰卫生研究与发展组织和迈柯唯心肺公司[洁定集团]资助；INCEPTION临床试验注册号，NCT03101787。）
