Posterior left pericardiotomy for the prevention of atrial fibrillation after cardiac surgery: an adaptive, single-centre, single-blind, randomised, controlled trial
Posterior left pericardiotomy for the prevention of atrial fibrillation after cardiac surgery: an adaptive, single-centre, single-blind, randomised, controlled trial
复制标题
DOI：
10.1016/s0140-6736(21)02490-9
复制
发表时间：
2021-12-02
期刊：
影响因子：
168.9
通讯作者：
Girardi, Leonard
中科院分区：
文献类型：
--
作者：
Gaudino, Mario;Sanna, Tommaso;Girardi, Leonard
背景：心房颤动是心脏手术后最常见的并发症，与住院时间延长和不良后果增加有关，包括死亡和中风。心包积液在心脏手术后很常见，可引发心房颤动。我们检验了左后心包切开术（一种将心包间隙引流至左胸膜腔的手术手法）可能减少心脏手术后房颤的发生率的假设。方法：在这项适应性、随机、对照试验中，我们招募了成年患者（年龄=18岁），他们接受了冠状动脉、主动脉瓣或升主动脉的选择性干预，或这些干预的组合，由美国纽约州纽约长老会医院威尔康奈尔医学院心胸外科的成员进行。如果患者没有房颤史或其他心律失常或实验干预的禁忌症，则符合条件。符合条件的患者被随机分配（1:1），根据CHA2DS2-VASc评分分层，并采用混合分组随机化方法（分组大小为4,6和8），进行左后心包切开术或不干预。患者和评估人员对治疗分配不知情。随访至出院后30天。主要终点是术后住院期间房颤的发生率，在意向治疗（ITT）人群中进行评估。在接受治疗的人群中评估安全性。该研究已在ClinicalTrials.gov注册，编号NCT02875405，现已完成。结果：在2017年9月18日至2021年8月2日期间，筛选了3601例患者，其中420例被纳入，并随机分配到左侧后心包切开术组（n=212）或不干预组（n=208； ITT人群）。中位年龄为61.0岁（IQR 53.0 ~ 70.0），女性102例（24%），男性318例（76%），CHA2DS2-VASc中位评分为2.0 （IQR 1.0 ~ 3.0）。两组在临床和手术特征方面是平衡的。无患者失访，数据完整性100%。左侧后心包切开术组3例患者未接受干预。在ITT人群中，左后心包切开术组术后房颤发生率明显低于未干预组（212例中37例[17%]vs 208例中66例[32%][p=0.0007]；优势比调整为分层变量0.44 [95% CI 0.27-0.70; p=0.0005]）。209例患者中2例（1%）为左后心包切开术组，1例(
Background: Atrial fibrillation is the most common complication after cardiac surgery and is associated with extended in-hospital stay and increased adverse outcomes, including death and stroke. Pericardial effusion is common after cardiac surgery and can trigger atrial fibrillation. We tested the hypothesis that posterior left pericardiotomy, a surgical manoeuvre that drains the pericardial space into the left pleural cavity, might reduce the incidence of atrial fibrillation after cardiac surgery.Methods: In this adaptive, randomised, controlled trial, we recruited adult patients (aged =18 years) undergoing elective interventions on the coronary arteries, aortic valve, or ascending aorta, or a combination of these, performed by members of the Department of Cardiothoracic Surgery from Weill Cornell Medicine at the New York Presbyterian Hospital in New York, NY, USA. Patients were eligible if they had no history of atrial fibrillation or other arrhythmias or contraindications to the experimental intervention. Eligible patients were randomly assigned (1:1), stratified by CHA2DS2-VASc score and using a mixed-block randomisation approach (block sizes of 4, 6, and 8), to posterior left pericardiotomy or no intervention. Patients and assessors were blinded to treatment assignment. Patients were followed up until 30 days after hospital discharge. The primary outcome was the incidence of atrial fibrillation during postoperative in-hospital stay, which was assessed in the intention-to-treat (ITT) population. Safety was assessed in the as-treated population. This study is registered with ClinicalTrials.gov, NCT02875405, and is now complete.Findings: Between Sept 18, 2017, and Aug 2, 2021, 3601 patients were screened and 420 were included and randomly assigned to the posterior left pericardiotomy group (n=212) or the no intervention group (n=208; ITT population). The median age was 61.0 years (IQR 53.0-70.0), 102 (24%) patients were female, and 318 (76%) were male, with a median CHA2DS2-VASc score of 2.0 (IQR 1.0-3.0). The two groups were balanced with respect to clinical and surgical characteristics. No patients were lost to follow-up and data completeness was 100%. Three patients in the posterior left pericardiotomy group did not receive the intervention. In the ITT population, the incidence of postoperative atrial fibrillation was significantly lower in the posterior left pericardiotomy group than in the no intervention group (37 [17%] of 212 vs 66 [32%] of 208 [p=0.0007]; odds ratio adjusted for the stratification variable 0.44 [95% CI 0.27-0.70; p=0.0005]). Two (1%) of 209 patients in the posterior left pericardiotomy group and one (