The BALANCE Study Clinical Benefit and Long-Term Outcome After Intracoronary Autologous Bone Marrow Cell Transplantation in Patients With Acute Myocardial Infarction
The BALANCE Study Clinical Benefit and Long-Term Outcome After Intracoronary Autologous Bone Marrow Cell Transplantation in Patients With Acute Myocardial Infarction
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DOI：
10.1016/j.jacc.2009.02.051
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发表时间：
2009-06-16
影响因子：
24
通讯作者：
Strauer, Bodo Eckehard
中科院分区：
文献类型：
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作者：
Yousef, Muhammad;Schannwell, Christiana Mira;Strauer, Bodo Eckehard
目的 本研究的目的是调查急性心肌梗死 (AMI) 后接受细胞治疗的患者心室血流动力学状态、几何结构和收缩性的改善程度以及长期临床结果。 背景 动物实验和临床研究表明，自体骨髓细胞 (BMC) 移植可以改善心室功能并防止重构。 方法 62 名患者在 AMI 后 7 +/- 2 天接受冠状动脉内自体 BMC 移植。将细胞直接注入梗塞相关动脉。对照组由 62 名具有相似左心室 (LV) 射血分数 (EF) 和诊断的患者组成。所有患者均接受多项检查（例如冠状动脉造影、右心导管插入术、双平面左心室造影、静息和运动时心电图 [ECG]、超声心动图、晚电位 [LP]、心率变异性 [HRV] 和 24 小时动态心电图）。 BMC 治疗后 3、12 和 60 个月进行治疗随访。结果 BMC 治疗后 3 个月，EF 和每搏量指数显着改善。梗塞面积显着减少8%。收缩速度（长度/秒、体积/秒）显着增加，心室功能曲线的斜率（收缩压/收缩末期体积）变得更陡。梗塞区收缩力显着改善，左心室缩短速度 (VCF) 增加 31%，尤其是梗塞区边缘区。相比之下，BMC 治疗前后非梗塞区域的 VCF 没有差异。此外，BMC 治疗后记录了异常 HRV、LP 和异位搏动的减少。 BMC 治疗后 12 个月和 60 个月，左心室收缩力、血流动力学状态和几何形状参数稳定。与对照组相比，治疗组患者的运动能力显着增强，死亡率显着降低。结论 BMC 治疗可显着且长期改善 AMI 后患者的左心室功能、生活质量和死亡率。 BMC治疗后未观察到副作用，表明BMC治疗是安全的。 (J Am Coll Cardiol 2009; 53: 22 62-9) (C) 2009 年，美国心脏病学会基金会
Objectives The aim of this study was to investigate the quantitative amount of improvement of ventricular hemodynamic status, geometry, and contractility as well as the long-term clinical outcome of cell-treated patients after acute myocardial infarction (AMI).Background Animal experiments as well as clinical studies have demonstrated that autologous bone marrow cell (BMC) transplantation might improve ventricular function and prevent remodeling.Methods Sixty-two patients underwent intracoronary autologous BMC transplantation 7 +/- 2 days after AMI. Cells were infused directly into the infarct-related artery. The control group consisted of 62 patients with comparable left ventricular (LV) ejection fraction (EF) and diagnosis. All patients had several examinations (e. g., coronary angiography, right heart catheterization, biplane left ventriculography, electrocardiogram [ECG] at rest and exercise, echocardiography, late potential [LP], heart rate variability [HRV], and 24-h Holter ECG). The therapeutic follow-up was performed 3, 12, and 60 months after BMC therapy.Results Three months after BMC therapy there was significant improvement of EF and stroke volume index. The infarct size was significantly reduced by 8%. Contraction velocities (lengths/second, volumes/second) increased significantly and the slope of the ventricular function curve (systolic pressure/end-systolic volume) became steeper. There was significant improvement of contractility in the infarct zone, as evidenced by a 31% increase of LV velocity of shortening (VCF), preferably in the border zone of the infarct zone. In contrast, the noninfarcted area showed no difference in VCF before and after BMC therapy. Furthermore, decreases of abnormal HRV, LP, and ectopic beats were documented after BMC therapy. Twelve and 60 months after BMC therapy the parameters of contractility, hemodynamic status, and geometry of the LV were stable. The exercise capacity of treated patients was significantly augmented, and the mortality was significantly reduced in comparison with the control group.Conclusions BMC therapy leads to significant and longstanding improvements of LV performance as well as quality of life and mortality of patients after AMI. After BMC therapy, no side effects were observed, showing that BMC therapy is safe. (J Am Coll Cardiol 2009; 53: 22 62-9) (C) 2009 by the American College of Cardiology Foundation