右心室起搏升级为心力衰竭心脏再同步治疗：一项随机试验。
Upgrade of right ventricular pacing to cardiac resynchronization therapy in heart failure: a randomized trial.
机构信息
Heart and Vascular Center, Semmelweis University, Varosmajor 68, H-1122 Budapest, Hungary.
Department of Cardiology and Angiology, National Institute of Cardiovascular Diseases and Slovak Medical University, Bratislava, Slovakia.
出版信息
Eur Heart J. 2023 Oct 21;44(40):4259-4269. doi: 10.1093/eurheartj/ehad591.
BACKGROUND AND AIMS
De novo implanted cardiac resynchronization therapy with defibrillator (CRT-D) reduces the risk of morbidity and mortality in patients with left bundle branch block, heart failure and reduced ejection fraction (HFrEF). However, among HFrEF patients with right ventricular pacing (RVP), the efficacy of CRT-D upgrade is uncertain.
METHODS
In this multicentre, randomized, controlled trial, 360 symptomatic (New York Heart Association Classes II-IVa) HFrEF patients with a pacemaker or implantable cardioverter defibrillator (ICD), high RVP burden ≥ 20%, and a wide paced QRS complex duration ≥ 150 ms were randomly assigned to receive CRT-D upgrade (n = 215) or ICD (n = 145) in a 3:2 ratio. The primary outcome was the composite of all-cause mortality, heart failure hospitalization, or <15% reduction of left ventricular end-systolic volume assessed at 12 months. Secondary outcomes included all-cause mortality or heart failure hospitalization.
RESULTS
Over a median follow-up of 12.4 months, the primary outcome occurred in 58/179 (32.4%) in the CRT-D arm vs. 101/128 (78.9%) in the ICD arm (odds ratio 0.11; 95% confidence interval 0.06-0.19; P < .001). All-cause mortality or heart failure hospitalization occurred in 22/215 (10%) in the CRT-D arm vs. 46/145 (32%) in the ICD arm (hazard ratio 0.27; 95% confidence interval 0.16-0.47; P < .001). The incidence of procedure- or device-related complications was similar between the two arms [CRT-D group 25/211 (12.3%) vs. ICD group 11/142 (7.8%)].
CONCLUSIONS
In pacemaker or ICD patients with significant RVP burden and reduced ejection fraction, upgrade to CRT-D compared with ICD therapy reduced the combined risk of all-cause mortality, heart failure hospitalization, or absence of reverse remodelling.
背景与目的
对于左束支传导阻滞、心力衰竭伴射血分数降低（HFrEF）的患者，新植入的心脏再同步治疗除颤器（CRT-D）可降低发病率和死亡率。然而，对于右心室起搏（RVP）的 HFrEF 患者，CRT-D 升级的疗效尚不确定。
方法
在这项多中心、随机、对照试验中，360 名有症状（纽约心脏协会 II-IVa 级）、HFrEF 患者，有起搏器或植入式心律转复除颤器（ICD），高 RVP 负荷≥20%，宽起搏 QRS 复合波持续时间≥150 ms，被随机分为 CRT-D 升级组（n=215）和 ICD 组（n=145），比例为 3:2。主要结局是 12 个月时评估的全因死亡率、心力衰竭住院或左心室收缩末期容积减少<15%的复合终点。次要结局包括全因死亡率或心力衰竭住院。
结果
中位随访 12.4 个月时，CRT-D 组 179 例中有 58 例（32.4%）发生主要结局，而 ICD 组 128 例中有 101 例（78.9%）发生主要结局（比值比 0.11；95%置信区间 0.06-0.19；P<0.001）。CRT-D 组 215 例中有 22 例（10%）发生全因死亡率或心力衰竭住院，而 ICD 组 145 例中有 46 例（32%）发生全因死亡率或心力衰竭住院（风险比 0.27；95%置信区间 0.16-0.47；P<0.001）。两组之间与手术或器械相关的并发症发生率相似[CRT-D 组 211 例中有 25 例（12.3%），ICD 组 142 例中有 11 例（7.8%）]。
结论
对于 RVP 负荷大、射血分数降低的起搏器或 ICD 患者，与 ICD 治疗相比，升级为 CRT-D 可降低全因死亡率、心力衰竭住院或无逆重构的综合风险。
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