Conduction System vs Biventricular Pacing in Heart Failure: The PhysioSync-HF Randomized Clinical Trial.

Background

To compare CSP vs BiVP on an HF-related outcome in patients with HFrEF and LBBB.

比较传导系统起搏（CSP）与双心室起搏（BiVP）在HFrEF和LBBB患者中心力衰竭相关结果的差异。

DESIGN, SETTING, AND PARTICIPANTS: PhysioSync-HF (Conduction System Pacing Versus Biventricular Resynchronization in Patients With Chronic Heart Failure) was an investigator-initiated, multicenter, noninferiority randomized clinical trial enrolling participants from November 2022 to December 2023 with 12 months of follow-up at 14 hospitals across all regions of Brazil.

设计、设置和参与者：PhysioSync-HF（传导系统起搏与双心室再同步化治疗慢性心力衰竭的比较）是一项由研究者发起的多中心、非劣效性随机临床试验，从2022年11月到2023年12月招募参与者，在巴西所有地区的14家医院进行为期12个月的随访。

Adults with symptomatic HFrEF (New York Heart Association NYHA] classes II through III), left ventricular ejection fraction (LVEF) of 35% or less, and LBBB (QRS duration ≥130 milliseconds) were eligible for inclusion.

符合条件的成年人包括有症状的HFrEF（纽约心脏协会NYHA II至III级）、左心室射血分数（LVEF）35%或以下以及LBBB（QRS间期≥130毫秒）。

Data were analyzed from May to August 2025.

数据分析时间为2025年5月至8月。

intervention

Patients were randomized 1:1 to either CSP (preferentially left bundle-branch area pacing) or BiVP.

患者按1:1的比例随机分配至CSP（优先左束支区域起搏）或BiVP。

main_outcomes_and_measures

The primary outcome was a hierarchical composite of death, HF hospitalizations, urgent HF visits, and change in LVEF at 12 months.

主要结果是一个层次化的复合指标，包括12个月内死亡、心力衰竭住院、紧急心力衰竭就诊以及左心室射血分数(LVEF)的变化。

The prespecified noninferiority margin for the odds ratio (OR) was 1.2.

预设的非劣效性边界为比值比(OR)为1.2。

Results

A total of 173 patients (median [IQR] age, 62 years [56-68]; 86 female patients [49.7%]; 115 (66.5%) with dilated cardiomyopathy; median [IQR] LVEF, 26% [22%-31%]; median [IQR] QRS, 180 milliseconds [170-200]) were included.

共有173名患者（中位年龄[四分位数间距]，62岁[56-68]；86名女性患者[49.7%]；115名（66.5%）患有扩张型心肌病；中位左心室射血分数[LVEF]，26%[22%-31%]；中位QRS间期，180毫秒[170-200]）被纳入研究。

At 12 months, CSP failed to meet noninferiority and was inferior to BiVP for the primary end point (OR, 2.36; 95% CI, 1.37-4.06; P = .99 for noninferiority; P = .002 for between-group difference).

在12个月时，CSP未能达到非劣效性，并且对于主要终点来说，与BiVP相比显示出劣势（OR，2.36；95%置信区间，1.37-4.06；非劣效性P值为.99；组间差异P值为.002）。

The time-to-event composite of death, HF hospitalizations, or urgent HF visits was higher in CSP (hazard ratio, 2.35; 95% CI, 0.99-5.61).

在CSP组中，死亡、心力衰竭住院或紧急心力衰竭就诊的事件时间复合终点更高（风险比，2.35；95%置信区间，0.99-5.61）。

Mean (SD) LVEF increased to 35% (12%) with CSP and 39% (12%) with BiVP (mean difference, 3.8%; 95% CI, 0.3%-7.3%).

平均（标准差）左心室射血分数（LVEF）在使用CSP后增加到35%（12%），而在使用BiVP后增加到39%（12%）（平均差异，3.8%；95%置信区间，0.3%-7.3%）。

Relative to baseline, both groups had comparable improvements in QRS duration, Kansas City Cardiomyopathy Questionnaire Overall Summary Score, NYHA class, and natriuretic peptide levels.

与基线相比，两组在QRS间期、堪萨斯城心肌病问卷总评分、纽约心脏病协会(NYHA)心功能分级和利钠肽水平方面均有可比性的改善。

Total direct medical cost related to the procedure and heart failure care was the equivalent of $7090 (95% CI, $5779-$8648) lower in patients randomized to CSP at 12 months.

随机分配到CSP的患者在12个月时，与程序和心力衰竭护理相关的总直接医疗成本比基线低了7090美元（95%置信区间，5779-8648美元）。

conclusions_and_relevance

In patients with HFrEF and LBBB, CSP was inferior to BiVP for a composite of death, HF hospitalizations, urgent HF visits, and change in LVEF at 12 months.

在患有射血分数降低的心力衰竭(HFrEF)和左束支传导阻滞(LBBB)的患者中，心脏同步化治疗(CSP)在12个月时对于死亡、心力衰竭住院、紧急心力衰竭就诊的复合结果以及左心室射血分数(LVEF)的变化方面，效果不如双心室起搏(BiVP)。

These findings do not support the routine use of CSP as the first-line resynchronization strategy in this population.

这些发现不支持在这一人群中将心脏同步化治疗(CSP)作为首选的再同步化策略进行常规使用。

trial_registration

ClinicalTrials.gov Identifier: NCT05572736.

临床试验注册号：NCT05572736。