左心室射血分数≤50%患者心脏再同步治疗中左束支区域起搏与双心室起搏的比较：国际协作性左束支区域起搏研究（I-CLAS）结果

Left bundle branch area pacing compared with biventricular pacing for cardiac resynchronization therapy in patients with left ventricular ejection fraction ≤50%: Results from the International Collaborative LBBAP Study (I-CLAS).

作者信息

Morcos Ramez, Vijayaraman Pugazhendhi, Cano Óscar, Zanon Francesco, Ponnusamy Shunmuga Sundaram, Herweg Bengt, Sharma Parikshit S, Jastrzebski Marek, Molina-Lerma Manuel, Whinnett Zachary I, Vernooy Kevin, Zou Jiangang, Nair Girish M, Pathak Rajeev K, Tung Roderick, Upadhyay Gaurav A, Curila Karol, Chelu Mihail G, Ellenbogen Kenneth A

机构信息

Geisinger Heart Institute, Wilkes-Barre, Pennsylvania.

出版信息

Heart Rhythm. 2025 Apr 25. doi: 10.1016/j.hrthm.2025.04.005.

DOI:10.1016/j.hrthm.2025.04.005

PMID:40288475

Abstract

BACKGROUND

Cardiac resynchronization therapy (CRT) with biventricular pacing (BVP) is an established treatment of heart failure with reduced ejection fraction and wide QRS. Left bundle branch area pacing (LBBAP) has emerged as a physiologic alternative by directly engaging the His-Purkinje system, potentially improving electrical resynchronization and clinical outcomes.

OBJECTIVE

The aim of the study was to compare the clinical outcomes between BVP and LBBAP in patients with left ventricular ejection fraction (LVEF) ≤50% undergoing CRT.

METHODS

This multicenter observational study included patients with LVEF ≤50% receiving CRT with either LBBAP or BVP at 18 centers from January 2018 to June 2023. The primary outcome was a composite of all-cause mortality or first heart failure hospitalization (HFH). Secondary outcomes included separate analyses of HFH and all-cause mortality. Propensity score matching was used to balance baseline characteristics. Kaplan-Meier curves, Cox proportional hazards models, and competing risk analyses were performed.

RESULTS

A total of 2579 patients were included (BVP, 1118; LBBAP, 1461). In the propensity score-matched cohort (BVP, 780; LBBAP, 780), LBBAP demonstrated shorter paced QRS duration (129 ± 19 ms vs 143 ± 22 ms; P < .001). LBBAP was associated with a significantly lower risk of the composite primary outcome (hazard ratio [HR], 0.81; 95% confidence interval [CI], 0.66-0.98; P = .048) and reduced HFH (HR, 0.63; 95% CI, 0.49-0.82; P < .001). No significant difference in all-cause mortality was observed (HR, 0.82; 95% CI, 0.63-1.07; P = .156). Procedural complications were lower with LBBAP (3.5% vs 6.5%, P = .004).

CONCLUSION

LBBAP was associated with superior electrical resynchronization, fewer HFHs, and lower procedural complications compared with BVP in patients with LVEF <50% requiring CRT. Randomized trials are needed to confirm long-term benefits.

摘要

背景

双心室起搏（BVP）的心脏再同步治疗（CRT）是治疗射血分数降低和QRS波增宽的心力衰竭的既定方法。左束支区域起搏（LBBAP）通过直接激活希氏-浦肯野系统已成为一种生理性替代方法，有可能改善电同步性和临床结局。

目的

本研究旨在比较接受CRT的左心室射血分数（LVEF）≤50%的患者中BVP和LBBAP的临床结局。

方法

这项多中心观察性研究纳入了2018年1月至2023年6月在18个中心接受LBBAP或BVP的CRT治疗的LVEF≤50%的患者。主要结局是全因死亡率或首次心力衰竭住院（HFH）的复合终点。次要结局包括对HFH和全因死亡率的单独分析。采用倾向评分匹配来平衡基线特征。进行了Kaplan-Meier曲线、Cox比例风险模型和竞争风险分析。

结果

共纳入2579例患者（BVP组1118例；LBBAP组1461例）。在倾向评分匹配队列中（BVP组780例；LBBAP组780例）中，LBBAP显示起搏QRS波时限更短（129±19毫秒对143±22毫秒；P<.001）。LBBAP与复合主要结局的风险显著降低相关（风险比[HR]，0.81；95%置信区间[CI]，0.66-0.98；P=.048），且HFH减少（HR，0.63；95%CI，0.49-0.82；P<.001）。在全因死亡率方面未观察到显著差异（HR，0.82；95%CI，0.63-1.07；P=.156）。LBBAP的手术并发症更低（3.5%对6.5%，P=.004）。