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心脏手术中心外膜脂肪垫注射肉毒毒素抑制心房颤动的长期效果:一项随机研究的 3 年随访。

Long-term suppression of atrial fibrillation by botulinum toxin injection into epicardial fat pads in patients undergoing cardiac surgery: Three-year follow-up of a randomized study.

机构信息

E. Meshalkin National Medical Research Center of the Ministry of Health of the Russian Federation, Novosibirsk, Russian Federation.

Institute of Cardiology, Siberian Division of Russian Academy of Medical Sciences, Tomsk, Russian Federation.

出版信息

Heart Rhythm. 2019 Feb;16(2):172-177. doi: 10.1016/j.hrthm.2018.08.019. Epub 2018 Nov 7.

Abstract

BACKGROUND

Botulinum toxin (BTX) injections into epicardial fat pads in patients undergoing coronary artery bypass grafting (CABG) has resulted in suppression of atrial fibrillation (AF) during the early postoperative period through 1-year of follow-up in a pilot program.

OBJECTIVE

The purpose of this study was to report 3-year AF patterns by the use of implantable cardiac monitors (ICMs).

METHODS

Sixty patients with a history of paroxysmal AF and indications for CABG were randomized 1:1 to either BTX or placebo injections into 4 posterior epicardial fat pads. All patients received an ICM with regular follow-up for 3 years after surgery. The primary end point of the extended follow-up period was incidence of any atrial tachyarrhythmia after 30 days of procedure until 36 months on no antiarrhythmic drugs. The secondary end points included clinical events and AF burden.

RESULTS

At the end of 36 months, the incidence of any atrial tachyarrhythmia was 23.3% in the BTX group vs 50% in the placebo group (hazard ratio 0.36; 95% confidence interval 0.14-0.88; P = .02). AF burden at 12, 24, and 36 months was significantly lower in the BTX group than in the placebo group: 0.22% vs 1.88% (P = .003), 1.6% vs 9.5% (P < .001), and 1.3% vs 6.9% (P = .007), respectively. In the BTX group, 2 patients (7%) were hospitalized during follow-up compared with 10 (33%) in the placebo group (P = .02).

CONCLUSION

Injection of BTX into epicardial fat pads in patients undergoing CABG resulted in a sustained and substantial reduction in atrial tachyarrhythmia incidence and burden during 3-year follow-up, accompanied by reduction in hospitalizations.

摘要

背景

在一项试点计划中,在接受冠状动脉旁路移植术(CABG)的患者的心外膜脂肪垫中注射肉毒杆菌毒素(BTX),可在术后早期至术后 1 年期间抑制心房颤动(AF)。

目的

本研究旨在通过植入式心脏监测器(ICM)报告 3 年的 AF 模式。

方法

60 例有阵发性 AF 病史且有 CABG 适应证的患者按 1:1 随机分为 BTX 或安慰剂注射到 4 个心外膜后脂肪垫。所有患者均在手术后接受 ICM 常规随访 3 年。扩展随访期的主要终点是术后 30 天至 36 个月期间无抗心律失常药物的任何房性心动过速的发生率。次要终点包括临床事件和 AF 负担。

结果

在 36 个月时,BTX 组任何房性心动过速的发生率为 23.3%,安慰剂组为 50%(风险比 0.36;95%置信区间 0.14-0.88;P =.02)。BTX 组的 AF 负担在 12、24 和 36 个月时明显低于安慰剂组:0.22%比 1.88%(P =.003),1.6%比 9.5%(P <.001),1.3%比 6.9%(P =.007)。BTX 组在随访期间有 2 例(7%)患者住院,而安慰剂组有 10 例(33%)患者住院(P =.02)。

结论

在接受 CABG 的患者的心外膜脂肪垫中注射 BTX 可在 3 年随访期间持续且显著降低房性心动过速的发生率和负担,同时减少住院治疗。

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