Romanov Alexander, Goscinska-Bis Kinga, Bis Jaroslaw, Chernyavskiy Alexander, Prokhorova Darya, Syrtseva Yana, Shabanov Vitaliy, Alsov Sergey, Karaskov Alexander, Deja Marek, Krejca Michal, Pokushalov Evgeny
State Research Institute of Circulation Pathology, Novosibirsk, Russian Federation
Medical University of Silesia, Katowice, Poland.
Eur J Cardiothorac Surg. 2016 Jul;50(1):36-41. doi: 10.1093/ejcts/ezv448. Epub 2015 Dec 30.
Totally epicardial cardiac resynchronization therapy (CRT) is a novel treatment modality for patients with heart failure (HF) and systolic dyssynchrony undergoing coronary artery bypass grafting (CABG). In this study, we have prospectively evaluated the long-term outcomes of totally epicardial CRT.
Between September 2007 and June 2009, one hundred and seventy-eight patients were randomly assigned to the CABG alone group (n = 87) and CABG with concomitant epicardial CRT implantation (n = 91). The primary end-point of the study was all-cause mortality in the two groups between the day of surgery and 13 August 2013 (common closing date). The secondary outcomes included mode of death, adverse cardiac events and lead performance.
The mean follow-up was 55 ± 10.7 months. According to per-protocol analysis with treatment as a time-dependent variable to account for conversion from CABG to CABG + CRT, there were 24 deaths (35.8%) in the CABG group and 17 deaths (15.3%) in the CABG + CRT group. When compared with CABG alone, concomitant CRT was associated with reduced risk of both all-cause mortality [hazard ratio (HR) 0.43, 95% confidence interval (CI) 0.23-0.84, P = 0.012] and cardiac death (HR 0.39, 95% CI 0.21-0.72, P = 0.002). Eleven (12.6%) sudden deaths were observed in the CABG group in comparison with 4 (4.4%) in the CABG + CRT group (P = 0.048). Hospital readmission was required for 9 (9.9%) patients in CABG + CRT group and for 25 (28.7%) patients in the CABG group (P = 0.001). There were 4 (1.5%) epicardial lead failures.
The results of our study suggest that the procedure of CABG and totally epicardial CRT system implantation is safe and significantly improves the survival of patients with HF and dyssynchrony during long-term follow-up.
NCT 00846001 (http://www.clinicaltrials.gov).
全皮下心脏再同步治疗（CRT）是一种针对心力衰竭（HF）且存在收缩不同步的患者在接受冠状动脉旁路移植术（CABG）时采用的新型治疗方式。在本研究中，我们前瞻性地评估了全皮下CRT的长期疗效。
在2007年9月至2009年6月期间，178例患者被随机分配至单纯CABG组（n = 87）和同期进行皮下CRT植入的CABG组（n = 91）。研究的主要终点是两组在手术日至2013年8月13日（共同截止日期）之间的全因死亡率。次要结局包括死亡方式、不良心脏事件和导线性能。
平均随访时间为55±10.7个月。根据将治疗作为时间依赖性变量的符合方案分析，以考虑从CABG转换为CABG + CRT的情况，CABG组有24例死亡（35.8%），CABG + CRT组有17例死亡（15.3%）。与单纯CABG相比，同期进行CRT与全因死亡率降低相关[风险比（HR）0.43，95%置信区间（CI）0.23 - 0.84，P = 0.012]以及心源性死亡降低相关（HR 0.39，95%CI 0.21 - 0.72，P = 0.002）。CABG组观察到11例（12.6%）猝死，而CABG + CRT组为4例（4.4%）（P = 0.048）。CABG + CRT组有9例（9.9%）患者需要再次住院，CABG组有25例（28.7%）患者需要再次住院（P = 0.001）。有4例（1.5%）皮下导线故障。
我们的研究结果表明，CABG及全皮下CRT系统植入手术是安全的，并且在长期随访中显著提高了HF和不同步患者的生存率。
NCT 00846001（http://www.clinicaltrials.gov）。
