Targeted left ventricular lead placement in biventricular pacing for heart failure: a national, multicentre, double-blind, randomised controlled trial in Denmark.

Observational data indicate better outcomes in patients with late myocardial activation at the left ventricular lead site.

观察数据表明，在左心室电极位置处有晚期心肌激活的患者预后更佳。

We aimed to test whether targeting the left ventricular lead at site of latest electrical activation improves outcomes.

我们的目标是测试将左心室电极定位在电活动最晚的部位是否能改善预后。

Methods

In this national, randomised, controlled, double-blinded, superiority trial we included patients from all five Danish university centres performing device implantation who had heart failure and wide QRS on guideline-directed medication, eligible for biventricular pacing.

在这项全国性的随机、对照、双盲、优效试验中，我们纳入了所有五家丹麦大学中心进行设备植入的患者，这些患者有心力衰竭和在指南指导下的药物治疗下宽QRS波，适合进行双心室起搏。

We randomly assigned (1:1) patients to either the intervention group, with left ventricular lead placement at the latest electrically activated site within the coronary sinus branches, or to control group, with left ventricular lead placement in a posterolateral non-apical branch.

我们以1:1的比例随机分配患者到干预组，即在冠状静脉窦分支内电活动最晚的部位放置左心室电极，或到对照组，即在后外侧非心尖分支放置左心室电极。

Primary outcome was a composite of time to death or first unplanned heart failure hospitalisation.

主要结果是死亡或首次计划外心力衰竭住院的时间的复合结果。

We used block randomisation and masked patients and all study personnel (except operating room personnel) to treatment allocation.

我们使用了分块随机化，并对患者和所有研究人员认治疗分配进行了盲法处理。

The primary outcome was a composite of time to death or first unplanned hospitalisation for heart failure.

主要结果是死亡或首次计划外心力衰竭住院的时间的复合结果。

Analysis followed a modified intention-to-treatapproach.

分析遵循了修改后的意向治疗分析方法。

Safety was assessed in all correctly assigned patients.

在所有正确分配的患者中评估了安全性。

The trial is registered at ClinicalTrials.gov (NCT03280862) and is complete.

该试验已在ClinicalTrials.gov注册（NCT03280862），并已完成。

Results

From March 20, 2018, to June 3, 2024, we included 1001 patients (255 females and 746 males); 499 were randomly assigned to the intervention group and 502 to the control group.

从2018年3月20日到2024年6月3日，我们共纳入了1001名患者（255名女性和746名男性）；499名被随机分配到干预组，502名被分配到对照组。

One incorrectly enrolled patient was excluded, leaving 1000 patients for the modified intention-to-treatanalysis.

一名错误入组的患者被排除，剩下1000名患者用于修改后的意向治疗分析。

Electrical activation at left ventricular lead was a mean of 9 milliseconds (95% CI 5-13) later in the intervention group.

左心室电极的电激活在干预组中平均晚了9毫秒（95% CI 5-13）。

Follow-up was completed on Feb 27, 2026, after a median 45·8 months (IQR 28·5-65·7).

随访在2026年2月27日完成，中位随访时间为45.8个月（四分位数间距28.5-65.7）。

The primary endpoint occurred in 139 (28%) of 499 patients in the intervention group and 128 (26%) of 501 in control group (hazard ratio1·10 [95% CI 0·86-1·39]; p=0·45).

主要终点事件在干预组的499名患者中有139例（28%）发生，在对照组的501名患者中有128例（26%）发生（风险比1.10 [95% CI 0.86-1.39]；p=0.45）。

Overall complication risk was similar between groups (71 [14%] patients in the intervention group vs 64 [13%] in the control group), but lead-related complications were more frequent in the intervention group.

两组之间的总体并发症风险相似（干预组71名（14%）患者与对照组64名（13%）患者），但干预组中与电极相关的并发症更为频繁。

One procedure-related death occurred in the intervention group.

干预组中发生了一例与手术相关的死亡。

interpretation

In patients with heart failure and prolonged QRS, targeted left ventricular lead placement at the site of latest electrical activation did not reduce the composite endpoint of death or unplanned hospitalisation for heart failure compared with conventional lead placement in a posterolateral, non-apical position.

对于心力衰竭和QRS间期延长的患者，将左心室电极定位于电活动最晚的部位，并未比在后外侧、非心尖部的传统电极放置减少死亡或因心力衰竭计划外住院的复合终点事件。

funding

Novo Nordisk Foundation, Danish Heart Foundation, Danish Pacemaker and ICD Registry, and Independent Research Fund Denmark.

诺和诺德基金会、丹麦心脏基金会、丹麦起搏器和ICD登记处以及丹麦独立研究基金会。