Žižek David, Žlahtič Tadej, Mrak Miha, Ivanovski Maja, Štublar Jernej, Džananović Dinko Zavrl, Peterlin Jakob, Cvijić Marta, Zupan Mežnar Anja
Cardiology Department, University Medical Centre Ljubljana, Zaloška 2, 1000 Ljubljana, Slovenia.
Faculty of Medicine, University of Ljubljana, Vrazov trg 2, 1000 Ljubljana, Slovenia.
Europace. 2025 Sep 1;27(9). doi: 10.1093/europace/euaf192.
There are limited prospective randomized studies comparing left bundle branch area pacing (LBBAP) and biventricular (BiV) pacing for cardiac resynchronization therapy (CRT). The study tested whether LBBAP is non-inferior to BiV pacing in patients with Class I indication for CRT.
The CSP-SYNC study is an investigator-initiated, randomized, single-centre study. Sixty-two patients were randomized 1:1 to LBBAP or BiV. The primary study endpoint was the change in left ventricular ejection fraction (LVEF) at 6 months. Secondary endpoints included changes in echo and clinical parameters after 6 months and 12 months. Thirty-one patients were randomized to each arm. Most patients were males (71%), and 32% had ischaemic cardiomyopathy. At 6 months, similar improvement of LVEF was observed in the LBBAP group compared to the BiV group [14.0% (95% confidence interval (CI): 11.2-16.8) in LBBAP vs. 8.5% (95% CI: 5.6-11.2) in BiV] with a mean intergroup difference of 5.6% (95% CI: 1.6-9.5; P < 0.001 for non-inferiority). Both groups showed comparable decrease in LVESV [-64 mL (95% CI: -78 to -50) vs. -40 mL (95% CI: -54 to -25) respectively, mean difference -24 mL (CI 95%: -44 to -4); P < 0.001 for non-inferiority] and changes in 6-min walk test (P < 0.001 for non-inferiority) and NYHA class (P = 0.011 for non-inferiority). Temporal trends of LV remodelling and heart failure hospitalization rates were also comparable.
In patients with a Class I indication for CRT, LBBAP was non-inferior to BiV pacing in improving LVEF and provided similar structural and electrical remodelling.
比较左束支区域起搏（LBBAP）和双心室（BiV）起搏用于心脏再同步治疗（CRT）的前瞻性随机研究有限。本研究旨在测试在有CRT I类适应症的患者中，LBBAP是否不劣于BiV起搏。
CSP-SYNC研究是一项由研究者发起的、随机、单中心研究。62例患者按1:1随机分为LBBAP组或BiV组。主要研究终点是6个月时左心室射血分数（LVEF）的变化。次要终点包括6个月和12个月后超声心动图和临床参数的变化。每组随机分配31例患者。大多数患者为男性（71%），32%患有缺血性心肌病。6个月时，与BiV组相比，LBBAP组LVEF有相似程度的改善[LBBAP组为14.0%（95%置信区间（CI）：11.2-16.8），BiV组为8.5%（95%CI：5.6-11.2）]，组间平均差异为5.6%（95%CI：1.6-9.5；非劣效性P<0.001）。两组左心室收缩末期容积均有相当程度的下降[-64mL（95%CI：-78至-50）对-40mL（95%CI：-54至-25），平均差异-24mL（95%CI：-44至-4）；非劣效性P<0.001]，6分钟步行试验变化（非劣效性P<0.001）和纽约心脏协会（NYHA）心功能分级（非劣效性P=0.011）也相似。左心室重构的时间趋势和心力衰竭住院率也相当。
在有CRT I类适应症的患者中，LBBAP在改善LVEF方面不劣于BiV起搏，并提供相似的结构和电重构。
