Department of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, Aarhus N, Denmark.
Department of Nuclear Medicine, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, Aarhus N, Denmark.
Europace. 2019 Sep 1;21(9):1369-1377. doi: 10.1093/europace/euz184.
To test in a double-blinded, randomized trial whether the combination of electrically guided left ventricular (LV) lead placement and post-implant interventricular pacing delay (VVd) optimization results in superior increase in LV ejection fraction (LVEF) in cardiac resynchronization therapy (CRT) recipients.
Stratified according to presence of ischaemic heart disease, 122 patients were randomized 1:1 to LV lead placement targeted towards the latest electrically activated segment identified by systematic mapping of the coronary sinus tributaries during CRT implantation combined with post-implant VVd optimization (intervention group) or imaging-guided LV lead implantation by cardiac computed tomography venography, 82Rubidium myocardial perfusion imaging and speckle tracking echocardiography targeting the LV lead towards the latest mechanically activated non-scarred myocardial segment (control group). Follow-up was 6 months. Primary endpoint was absolute increase in LVEF. Additional outcome measures were changes in New York Heart Association class, 6-minute walk test, and quality of life, LV reverse remodelling, and device related complications. Analysis was intention-to-treat. A larger increase in LVEF was observed in the intervention group (11 ± 10 vs. 7 ± 11%; 95% confidence interval 0.4-7.9%, P = 0.03); when adjusting for pre-specified baseline covariates this difference did not maintain statistical significance (P = 0.09). Clinical response, LV reverse remodelling, and complication rates did not differ between treatment groups.
Electrically guided CRT implantation appeared non-inferior to an imaging-guided strategy considering the outcomes of change in LVEF, LV reverse remodelling and clinical response. Larger long-term studies are warranted to investigate the effect of an electrically guided CRT strategy.
在一项双盲、随机试验中检验,与基于影像学指导的左心室(LV)导线植入和术后心室间起搏延迟(VVd)优化相比,电引导LV 导线放置联合术后 VVd 优化是否能更有效地提高心脏再同步治疗(CRT)患者的左心室射血分数(LVEF)。
根据是否存在缺血性心脏病,将 122 例患者分层,1:1 随机分为两组,一组为 LV 导线植入采用电引导策略,即在 CRT 植入过程中通过系统地对冠状窦分支进行标测,以确定最晚激活的电激动节段,并结合术后 VVd 优化;另一组为 LV 导线植入采用影像学引导策略,通过心脏计算机断层静脉造影、82Rubidium 心肌灌注成像和斑点追踪超声心动图,以最晚机械激活的非瘢痕心肌节段为目标。随访时间为 6 个月。主要终点是 LVEF 的绝对增加。其他观察终点包括纽约心脏协会(NYHA)心功能分级、6 分钟步行试验和生活质量、LV 逆重构以及器械相关并发症的变化。分析采用意向治疗。电引导组的 LVEF 增加幅度更大(11±10% vs. 7±11%;95%置信区间 0.4-7.9%,P=0.03);但在调整了预先指定的基线协变量后,这种差异没有统计学意义(P=0.09)。两组之间的临床反应、LV 逆重构和并发症发生率没有差异。
考虑到 LVEF、LV 逆重构和临床反应的变化,电引导 CRT 植入在疗效上并不逊于基于影像学的策略。需要进行更大规模的长期研究来探讨电引导 CRT 策略的效果。