Randomized Trial of Left Bundle Branch Pacing vs Right Ventricular Pacing in Vulnerable Cardiac Function.

Left bundle branch pacing (LBBP), a more physiological pacing modality, may better preserve cardiac function.

左束支起搏（LBBP），一种更符合生理的起搏方式，可能更好地保护心脏功能。

This randomized trial aimed to evaluate the clinical outcomes of LBBP vs RVP in patients with a high pacing burden with high risk of cardiac dysfunction.

这项随机试验旨在评估在高起搏负担且心脏功能障碍风险高的患者中，左束支区域起搏(LBBP)与右室起搏(RVP)的临床结果。

Methods

In this prospective, multicenter, randomized controlled trial, 160 patients with a high pacing burden with high risk of cardiac dysfunction were randomly assigned in a 1:1 ratio to either LBBP or RVP.

在这项前瞻性、多中心、随机对照试验中，160名高起搏负担且心脏功能障碍风险高的患者按1:1的比例随机分配到左束支区域起搏(LBBP)组或右室起搏(RVP)组。

The primary endpoint was a composite of all-cause mortality, heart failure hospitalization, or PICM.

主要终点是全因死亡、心力衰竭住院或PICM的复合终点。

Secondary endpoints were the individual components of the primary endpoints, echocardiographic parameters, and NYHA functional class.

次要终点是主要终点的各个组成部分、超声心动图参数和NYHA功能分级。

Results

During a median follow-up duration of 36 months, the primary endpoint occurred in 9 patients in the LBBP group and in 25 patients in the RVP group (11.6% vs 33.9%; HR: 0.310; 95% CI: 0.145-0.664; P = 0.001), mainly driven by PICM (6.5% vs 18.2%; subdistribution HR: 0.324; 95% CI: 0.119-0.883; P = 0.028).

在中位随访时间为36个月时，LBBP组有9名患者和RVP组有25名患者发生了主要终点事件（11.6% vs 33.9%；HR: 0.310；95% 置信区间: 0.145-0.664；P = 0.001），主要由PICM驱动（6.5% vs 18.2%；亚分布HR: 0.324；95% 置信区间: 0.119-0.883；P = 0.028）。

No significant differences were observed in all-cause mortality (P = 0.391) and heart failure hospitalization (P = 0.100) between 2 groups.

两组之间全因死亡率（P = 0.391）和心力衰竭住院率（P = 0.100）没有显著差异。

LBBP showed superior improvements over RVP in left ventricular ejection fraction (mean difference: 5.34; 95% CI: 3.18-7.50; P < 0.001), left ventricular end-diastolic diameter (mean difference: -3.06; 95% CI: -4.38 to -1.73; P < 0.001), and left ventricular end-systolic diameter (mean difference: -3.74; 95% CI: -5.07 to -2.41; P < 0.001) from baseline to 36 months.

LBBP在左心室射血分数（平均差异：5.34；95% 置信区间：3.18-7.50；P < 0.001）、左心室舒张末期内径（平均差异：-3.06；95% 置信区间：-4.38至-1.73；P < 0.001）和左心室收缩末期内径（平均差异：-3.74；95% 置信区间：-5.07至-2.41；P < 0.001）方面，从基线到36个月的改善均优于RVP。

Patients in the LBBP group also showed favored NYHA functional class compared with those in the RVP group at the 36-month follow-up (1.66 ± 0.60 vs 1.90 ± 0.56, P = 0.014).

在36个月的随访中，LBBP组患者的纽约心脏病协会（NYHA）功能分级也优于RVP组（1.66 ± 0.60 vs 1.90 ± 0.56, P = 0.014）。

Conclusions

In patients with a high pacing burden with high risk of cardiac dysfunction, LBBP significantly reduced the risk of the composite outcome, driven primarily by a decreased risk of PICM, and is associated with better echocardiographic improvements and clinical function.

在高起搏负荷且心脏功能障碍风险高的患者中，左束支区域起搏（LBBP）显著降低了复合终点事件的风险，主要由心室充盈压增高（PICM）风险的降低所驱动，并且与更好的超声心动图改善和临床功能相关。

(A multicenter, prospective, randomized, controlled trial of left bundle branch pacing and right ventricular pacing in preventing deterioration of cardiac function in patients with ventricular pacing dependence [LBBP-FAVOUR]; ChiCTR2000036553).

（一项多中心、前瞻性、随机、对照试验，研究左束支区域起搏与右心室起搏在预防依赖心室起搏患者心脏功能恶化中的作用 [LBBP-FAVOUR]; ChiCTR2000036553）。