Partial Cardiac Denervation to Prevent Postoperative Atrial Fibrillation After Coronary Artery Bypass Grafting: The pCAD-POAF Randomized Clinical Trial.

Background

To investigate whether partial cardiac denervation, achieved by cutting off the ligament of Marshall (LOM) and resecting the fat pad along the Waterston groove, can reduce the risk of POAF following CABG.

研究部分心脏去神经化，通过切断马歇尔韧带（LOM）和切除Waterston沟旁的脂肪垫，是否能降低冠状动脉旁路移植术（CABG）后新发房颤（POAF）的风险。

DESIGN, SETTING AND PARTICIPANTS: This single-center, randomized clinical trial enrolled adult patients scheduled for isolated CABG in China.

设计、场所和参与者：这项单中心、随机临床试验在中国招募了计划接受孤立冠状动脉旁路移植术（CABG）的成年患者。

Enrollment was from August 15, 2022, to December 13, 2023; follow-up visits were 30 days after discharge.

招募时间为2022年8月15日至2023年12月13日；出院后30天进行随访访问。

Methods

Participants were randomized into the intervention group (CABG plus partial cardiac denervation) and the control group (CABG only) in a 1:1 pattern.

参与者被随机分配到干预组（冠状动脉旁路移植术加部分心脏去神经化）和对照组（仅冠状动脉旁路移植术），比例为1:1。

All participants were continuously monitored for the incidenceof POAF until day 6 after the operation.

所有参与者在手术后第6天持续监测新发房颤的发生率。

main_outcome_and_measures

The primary end point was the incidenceof POAF in 6 days, defined as a supraventricular arrhythmia lasting for more than 30 seconds.

主要终点是6天内新发房颤的发生率，定义为持续超过30秒的房上性心律失常。

Results

The trial enrolled 430 patients (79 [18.4%] female; mean [SD] age, 61.9 [7.8] years).

该试验招募了430名患者（女性79名[18.4%]；平均[标准差]年龄为61.9[7.8]岁）。

Compared with the control group, the 6-day incidenceof POAF was significantly lower in the intervention group (18.1% vs 31.6%; P = .001; risk ratio, 0.57 [95% CI, 0.41-0.81]).

与对照组相比，干预组6天内的房颤发生率显著降低（18.1%对比31.6%；P = .001；风险比，0.57 [95% 置信区间, 0.41-0.81]）。

To further support these results, a sensitivity analysis performed with Kaplan-Meier survival curves also showed a significant reduction in the occurrence of POAF in the intervention group (hazard ratio, 0.53 [95% CI, 0.36-0.79]; P = .002).

为了进一步支持这些结果，使用Kaplan-Meier生存曲线进行的敏感性分析也显示干预组房颤发生率显著降低（风险比，0.53 [95% 置信区间, 0.36-0.79]；P = .002）。

Safety assessments showed no difference between the 2 groups, while postoperative medical cost was reduced in the intervention group.

安全性评估显示两组之间没有差异，而干预组的术后医疗费用有所减少。

conclusions_and_relevance

This randomized clinical trial found that partial cardiac denervation was an effective procedure to reduce the occurrence of POAF after isolated CABG without additional postoperative complications.

这项随机临床试验发现，部分心脏去神经化是一种有效的手术程序，可以在没有额外术后并发症的情况下减少孤立性冠状动脉旁路移植术后新发房颤的发生。

These results suggest that partial cardiac denervation may be a good option for cardiac surgeons to consider for preventing POAF after CABG.

这些结果表明，部分心脏去神经化可能是心脏外科医生在预防冠状动脉旁路移植术后房颤（POAF）时应考虑的一个好选择。

trial_registration

ClinicalTrials.gov Identifier: NCT05009914.

ClinicalTrials.gov 注册号：NCT05009914。