Wang Rong, Zhang Lin, Wang Yao, Gong Zhiyun, Xiao Cangsong, Wu Yang, Ren Chonglei, Cheng Nan, Gao Changqing
Department of Cardiovascular Surgery, Chinese People's Liberation Army General Hospital, Institute of Cardiac Surgery, Beijing, China.
Heart Surg Forum. 2016 Jun 24;19(3):E131-8. doi: 10.1532/hsf.1505.
This study aimed to investigate whether intra-myocardial injection of autologous bone marrow mononuclear cells (aBMMNCs) into peri-scarred myocardium during coronary artery bypass grafting (CABG) improved the long-term outcome compared with CABG alone.
From April 2011 to December 2012, 33 patients with chronic ischemic heart failure were randomly assigned to undergo CABG (control group) or CABG combined with intra-myocardial injection of aBMMNCs (treatment group). The primary endpoints of the study were the changes of left ventricular ejection fraction (LVEF), left ventricular end-diastolic volume (LVEDV), and left ventricular end-systolic volume (LVESV) from baseline to six-month and two-year follow-up, respectively. The secondary endpoints were the changes of III and IV NYHA classification, 6-minute walk test, B-type natriuretic peptide (BNP) from baseline to follow-up, and major adverse cardiovascular events (MACES) during the follow-up.
No patient died and no severe surgical complication occurred perioperatively in either group. The mean number of transplanted aBMMNCs was 98.5 ± 48.3×106 per patient. The follow-up was completed at six months and 24 months postoperatively. No major transplant-related adverse events were detected during the study. The patients in the treatment group had more significant improvement in LVEF than in the control group at six-month follow-up (8.17% versus 4.71%, P = .020), but this benefit was not found at 24-month follow-up (7.44% versus 5.69%, P = .419). There was no significant difference in changes of LVEDV, LVESV, III and IV NYHA classification, 6-minute walk distance, BNP, and MACES between the two groups all through the study.
Intra-myocardial injection of aBMMNC transplantation on arrested heart during CABG is a safe procedure based on a longer period observation. The patients with chronic ischemic heart failure can benefit from aBMMNCs transplantation in the short-term (6 months) demonstrated by improved global LVEF compared with the control group; however, this additional benefit dimed with time as showed by 24-month clinical and echocardiographic follow-up results.
本研究旨在探讨在冠状动脉旁路移植术（CABG）期间向瘢痕周围心肌内注射自体骨髓单个核细胞（aBMMNCs）与单纯CABG相比是否能改善长期预后。
2011年4月至2012年12月，33例慢性缺血性心力衰竭患者被随机分配接受CABG（对照组）或CABG联合心肌内注射aBMMNCs（治疗组）。该研究的主要终点分别是从基线到6个月和2年随访时左心室射血分数（LVEF）、左心室舒张末期容积（LVEDV）和左心室收缩末期容积（LVESV）的变化。次要终点是从基线到随访时纽约心脏协会（NYHA）III级和IV级分级、6分钟步行试验、B型利钠肽（BNP）的变化以及随访期间的主要不良心血管事件（MACE）。
两组患者围手术期均无死亡，也未发生严重手术并发症。每位患者移植的aBMMNCs平均数量为98.5±48.3×10⁶。术后6个月和24个月完成随访。研究期间未检测到与移植相关的重大不良事件。在6个月随访时，治疗组患者的LVEF改善比对照组更显著（8.17%对4.71%，P = 0.020），但在24个月随访时未发现这种益处（7.44%对5.69%，P = 0.419）。在整个研究过程中，两组之间LVEDV、LVESV、NYHA III级和IV级分级、6分钟步行距离、BNP和MACE的变化均无显著差异。
基于较长时间的观察，在CABG期间对停跳心脏进行心肌内注射aBMMNC移植是一种安全的手术。与对照组相比，慢性缺血性心力衰竭患者在短期内（6个月）可从aBMMNCs移植中获益，表现为整体LVEF改善；然而，24个月的临床和超声心动图随访结果显示，这种额外的益处随时间逐渐消失。
