Posterior left pericardiotomy for the prevention of atrial fibrillation after cardiac surgery: an adaptive, single-centre, single-blind, randomised, controlled trial,The Lancet

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Posterior left pericardiotomy for the prevention of atrial fibrillation after cardiac surgery: an adaptive, single-centre, single-blind, randomised, controlled trial
The Lancet ( IF 168.9 ) Pub Date : 2021-11-14 , DOI: 10.1016/s0140-6736(21)02490-9
Mario Gaudino ₁ , Tommaso Sanna ₂ , Karla V Ballman ₃ , N Bryce Robinson ₁ , Irbaz Hameed ₁ , Katia Audisio ₁ , Mohamed Rahouma ₁ , Antonino Di Franco ₁ , Giovanni J Soletti ₁ , Christopher Lau ₁ , Lisa Q Rong ₄ , Massimo Massetti ₂ , Marc Gillinov ₅ , Niv Ad ₆ , Pierre Voisine ₇ , J Michael DiMaio ₈ , Joanna Chikwe ₉ , Stephen E Fremes ₁₀ , Filippo Crea ₂ , John D Puskas ₁₁ , Leonard Girardi ₁ ,

Affiliation

Department of Cardiothoracic Surgery, Weill Cornell Medicine, New York, NY, USA.
Department of Cardiovascular Medicine, Fondazione Policlinico Universitario A Gemelli IRCCS, Rome, Italy; Department of Cardiovascular and Pulmonary Sciences, Catholic University of the Sacred Heart, Rome, Italy.
Alliance Statistics and Data Center, Weill Medical College of Cornell University, New York, NY, USA.
Department of Anesthesiology, Weill Cornell Medicine, New York, NY, USA.
Department of Thoracic and Cardiovascular Surgery, Heart and Vascular Institute, Cleveland Clinic, Cleveland, OH, USA.
Division of Cardiothoracic Surgery, Washington Adventist Hospital and University of Maryland, Tacoma Park, MD, USA.
Division of Cardiac Surgery, Department of Cardiology, Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ), Québec City, QC, Canada.
Department of Cardiothoracic Surgery, Baylor Scott & White The Heart Hospital, Plano, TX, USA.
Department of Cardiac Surgery, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
Schulich Heart Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, Canada.
Department of Cardiovascular Surgery, Mount Sinai Morningside, New York, NY, USA.

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 (<1%) of 211 in the no intervention group died within 30 days after hospital discharge. The incidence of postoperative pericardial effusion was lower in the posterior left pericardiotomy group than in the no intervention group (26 [12%] of 209 vs 45 [21%] of 211; relative risk 0·58 [95% CI 0·37–0·91]). Postoperative major adverse events occurred in six (3%) patients in the posterior left pericardiotomy group and in four (2%) in the no intervention group. No posterior left pericardiotomy related complications were seen.

Interpretation

Posterior left pericardiotomy is highly effective in reducing the incidence of atrial fibrillation after surgery on the coronary arteries, aortic valve, or ascending aorta, or a combination of these without additional risk of postoperative complications.

Funding

None

中文翻译：

左后心包切开术预防心脏手术后心房颤动：一项适应性、单中心、单盲、随机、对照试验

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结局增加有关，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（一种将心包空间引流到左侧胸膜腔的手术操作）可能降低心脏手术后心房颤动发生率的假设。

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），这些患者正在接受冠状动脉、主动脉瓣或升主动脉的选择性干预，或这些干预措施的组合，由来自美国纽约州纽约长老会医院的威尔康奈尔医学中心。如果患者没有心房颤动或其他心律失常病史或没有实验干预的禁忌症，则他们符合条件。符合条件的患者被随机分配 (1:1)，按 CHA ₂ DS _2分层-VASc 评分并使用混合区组随机化方法（区组大小为 4、6 和 8）进行左后心包切开术或不干预。患者和评估者对治疗分配不知情。患者出院后随访至 30 天。主要结果是术后住院期间心房颤动的发生率，在意向治疗 (ITT) 人群中进行了评估。在接受治疗的人群中评估安全性。该研究已在 ClinicalTrials.gov 注册，NCT02875405，现已完成。

发现

在 2017 年 9 月 18 日至 2021 年 8 月 2 日期间，筛选了 3601 名患者，其中 420 名患者被随机分配到左后心包切开术组（n=212）或无干预组（n=208；ITT 人群）。中位年龄为 61 0 岁（IQR 53 0–70 0），102 名（24%）患者为女性，318 名（76%）为男性，中位 CHA ₂ DS ₂-VASc 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。没有患者失访，数据完整性为100%。左后心包切开术组3例患者未接受干预。在 ITT 人群中，左后心包切开术组术后心房颤动的发生率显着低于未干预组（212 例中的 37 [17%] vs208 [p=0 0007] 中的 66 [32%]；针对分层变量调整的优势比 0 44 [95% CI 0 27–0 70；p = 0 0005]）。左后心包切开术组 209 名患者中有 2 名（1%）和无干预组 211 名患者中有 1 名（<1%）在出院后 30 天内死亡。左后心包切开术组术后心包积液的发生率低于无干预组（209 人中的 26 [12%] vs 211 人中的 45 [21%]；相对风险 0 58 [95% CI 0 37–0 91 ]）。左后心包切开术组 6 名 (3%) 患者和无干预组 4 名 (2%) 患者发生术后主要不良事件。未见左后心包切开术相关并发症。