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部分心脏去神经支配预防冠状动脉旁路移植术后房颤:pCAD-POAF随机临床试验

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

作者信息

Yang Ziang, Tiemuerniyazi Xieraili, Xu Fei, Wang Yang, Sun Yang, Yan Peng, Tian Liangxin, Han Chao, Zhang Yan, Pan Shiwei, Hu Zhan, Li Xi, Zhao Wei, Feng Wei

机构信息

Department of Cardiovascular Surgery, Fuwai Hospital, National Center for Cardiovascular Diseases, National Clinical Research Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.

Department of Medical Research and Biometrics Center, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.

出版信息

JAMA Cardiol. 2025 Jan 1;10(1):71-77. doi: 10.1001/jamacardio.2024.4639.

Abstract

IMPORTANCE

Efficient approaches to prevent postoperative atrial fibrillation (POAF) after coronary artery bypass grafting (CABG) are still needed.

OBJECTIVE

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.

DESIGN, SETTING AND PARTICIPANTS: This single-center, randomized clinical trial enrolled adult patients scheduled for isolated CABG in China. Enrollment was from August 15, 2022, to December 13, 2023; follow-up visits were 30 days after discharge.

INTERVENTIONS

Participants were randomized into the intervention group (CABG plus partial cardiac denervation) and the control group (CABG only) in a 1:1 pattern. All participants were continuously monitored for the incidence of POAF until day 6 after the operation.

MAIN OUTCOME AND MEASURES

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

RESULTS

The trial enrolled 430 patients (79 [18.4%] female; mean [SD] age, 61.9 [7.8] years). Compared with the control group, the 6-day incidence of 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]). 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). Safety assessments showed no difference between the 2 groups, while postoperative medical cost was reduced in the intervention group.

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

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT05009914.

摘要

重要性

冠状动脉旁路移植术(CABG)后预防术后心房颤动(POAF)的有效方法仍有待探索。

目的

探讨通过切断Marshall韧带(LOM)并切除沃特斯顿沟沿线脂肪垫实现的部分心脏去神经支配能否降低CABG后POAF的风险。

设计、地点和参与者:这项单中心随机临床试验纳入了在中国计划接受单纯CABG的成年患者。入组时间为2022年8月15日至2023年12月13日;出院后30天进行随访。

干预措施

参与者按1:1的比例随机分为干预组(CABG加部分心脏去神经支配)和对照组(仅CABG)。所有参与者持续监测POAF的发生率,直至术后第6天。

主要结局和测量指标

主要终点是术后6天内POAF的发生率,定义为持续超过30秒的室上性心律失常。

结果

该试验共纳入430例患者(79例[18.4%]为女性;平均[标准差]年龄为61.9[7.8]岁)。与对照组相比,干预组术后6天内POAF的发生率显著更低(18.1%对31.6%;P = 0.001;风险比,0.57[95%CI,0.41 - 0.81])。为进一步支持这些结果,采用Kaplan - Meier生存曲线进行的敏感性分析也显示干预组POAF的发生率显著降低(风险比,0.53[95%CI,0.36 - 0.79];P = 0.002)。安全性评估显示两组之间无差异,而干预组术后医疗费用有所降低。

结论和相关性

这项随机临床试验发现,部分心脏去神经支配是减少单纯CABG后POAF发生的有效方法,且无额外的术后并发症。这些结果表明,部分心脏去神经支配可能是心脏外科医生在预防CABG后POAF时可考虑的一个良好选择。

试验注册

ClinicalTrials.gov标识符:NCT05009914。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c366/11571071/a7eff4da62cb/jamacardiol-e244639-g001.jpg

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