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房室结消融术后伴射血分数降低的心房颤动患者行希氏束起搏与双心室起搏的比较:一项多中心、随机、交叉研究——ALTERNATIVE-AF 试验。

His-bundle pacing vs biventricular pacing following atrioventricular nodal ablation in patients with atrial fibrillation and reduced ejection fraction: A multicenter, randomized, crossover study-The ALTERNATIVE-AF trial.

机构信息

Department of Cardiology, the First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China; The Key Lab of Cardiovascular Disease, Science and Technology of Wenzhou, Wenzhou, China.

Department of Cardiology, the First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China; The Key Lab of Cardiovascular Disease, Science and Technology of Wenzhou, Wenzhou, China.

出版信息

Heart Rhythm. 2022 Dec;19(12):1948-1955. doi: 10.1016/j.hrthm.2022.07.009. Epub 2022 Jul 14.

Abstract

BACKGROUND

Atrioventricular nodal ablation (AVNA) combined with biventricular pacing (BVP) improves outcomes in patients with persistent atrial fibrillation (AF), adequate rate control, and reduced left ventricular ejection fraction (LVEF). His-bundle pacing (HBP) delivers physiological ventricular activation and is a promising alternative to BVP.

OBJECTIVE

The purpose of this trial was to compare HBP with BVP following AVNA.

METHODS

In this multicenter, prospective, randomized crossover trial, we recruited patients with persistent AF and reduced LVEF (≤40%). All patients underwent AVNA and received both HBP and BVP. Patients were randomized to either HBP or BVP for 9 months (phase 1), then were switched to the alternative pacing modality for the next 9 months (phase 2). The primary endpoint was change in LVEF.

RESULTS

Fifty patients (age 64.3 ± 10.3 years; ventricular rate 93.1 ± 19.9 bpm; 72% male) were enrolled. Thirty-eight patients completed the 2 phases and were included in the crossover analysis. A significant improvement in LVEF was observed with HBP compared to BVP (phase 1: ΔLVEF 21.3% and ΔLVEF 16.7%; phase 2: ΔLVEF 3.5% and ΔLVEF -2.4%; P = 0.015). Significant improvements in left ventricular end-diastolic diameter, New York Heart Association functional class, and B-type natriuretic peptide level were observed with both pacing modalities compared with baseline, whereas no significant differences were observed between HBP and BVP.

CONCLUSION

HBP delivers a modest but significant improvement in LVEF in patients with persistent AF, impaired ventricular function, and narrow QRS duration post-AVNA compared with BVP. Larger long-term trials are required to confirm the additional improvements in function with HBP.

摘要

背景

房室结消融(AVNA)联合双心室起搏(BVP)可改善持续性心房颤动(AF)、适当的心率控制和左心室射血分数(LVEF)降低的患者的预后。希氏束起搏(HBP)可提供生理性心室激动,是 BVP 的一种有前途的替代方法。

目的

本试验旨在比较 AVNA 后 HBP 与 BVP。

方法

在这项多中心、前瞻性、随机交叉试验中,我们招募了持续性 AF 和 LVEF 降低(≤40%)的患者。所有患者均接受 AVNA 治疗,并接受 HBP 和 BVP 治疗。患者随机接受 HBP 或 BVP 治疗 9 个月(第 1 阶段),然后在下 9 个月切换到另一种起搏方式(第 2 阶段)。主要终点是 LVEF 的变化。

结果

共纳入 50 例患者(年龄 64.3±10.3 岁;心室率 93.1±19.9 bpm;72%为男性)。38 例患者完成了 2 个阶段并纳入交叉分析。与 BVP 相比,HBP 可显著改善 LVEF(第 1 阶段:ΔLVEF 21.3%和ΔLVEF 16.7%;第 2 阶段:ΔLVEF 3.5%和ΔLVEF -2.4%;P=0.015)。与基线相比,两种起搏方式均显著改善了左心室舒张末期直径、纽约心脏协会功能分级和 B 型利钠肽水平,而 HBP 与 BVP 之间无显著差异。

结论

与 BVP 相比,AVNA 后持续性 AF、心室功能障碍和 QRS 波群时限狭窄的患者中,HBP 可适度但显著改善 LVEF。需要更大的长期试验来证实 HBP 在功能方面的额外改善。

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