Krause K, Jaquet K, Schneider C, Haupt S, Lioznov M V, Otte K-M, Kuck K-H
Department of Cardiology, Asklepios Hospital St Georg, Hamburg, Germany.
Heart. 2009 Jul;95(14):1145-52. doi: 10.1136/hrt.2008.155077. Epub 2009 Mar 30.
Clinical studies on intracoronary stem cell infusion in patients with acute myocardial infarction (AMI) have shown promising results for left ventricular ejection fraction (LVEF). However, preclinical studies have shown that intramyocardial cell injection is better than the intracoronary approach.
To test safety and feasibility of intramyocardial cell injection and left ventricular electromechanical mapping (EMM) early after AMI.
On day 10.5 (5) (mean (SD)) after AMI and percutaneous coronary intervention with stent implantation (culprit lesion: 15 LAD, 3 circumflex and 2 right coronary arteries) 20 patients (mean (SD) 60.4 (11.4) years) received bone marrow derived mononuclear cells in the low-voltage area using EMM-guided percutaneous intramyocardial injection. EMM and coronary angiography were performed in 15 patients at 6-months' follow-up. Echocardiography, recording of laboratory data and clinical assessment (6-month and 12-month follow-up) were carried out in all 20 patients.
None of the patients showed periprocedural complications. Three patients received an implantable cardioverter-defibrillator for primary prevention of sudden cardiac death and 6 (30%) patients showed in-stent restenosis. One patient underwent bypass surgery owing to chronic stent occlusion after 6 months. 2.0 (0.6)x10(8) cells, including 1.0 (0.3)x10(6) CD45(dim)/CD34(hi) stem cells, were injected in each patient. EMM showed a mean (SD) improvement from a baseline unipolar voltage of 45.5 (14.3)% to 59.3 (19.8)% of normal voltage (p = 0.002) and reduction of the low-voltage area from 28.7 (12.1)% to 20.3 (13.5)%; (p = 0.016). During the 12-month follow-up, the left ventricular ejection fraction (LVEF) improved from 40.8 (6.9)% to 47.1 (10.6)%; (p = 0.037).
Left ventricular EMM and percutaneous intramyocardial cell injection in patients with AMI was shown to be a safe procedure. It is associated with improved LVEF and electromechanical parameters after 12-months' follow-up.
Eudra-CT-No 2005-003629-19.
急性心肌梗死（AMI）患者冠状动脉内注入干细胞的临床研究显示左心室射血分数（LVEF）有良好结果。然而，临床前研究表明心肌内细胞注射优于冠状动脉途径。
检测AMI后早期心肌内细胞注射及左心室机电标测（EMM）的安全性和可行性。
在AMI及经皮冠状动脉介入并植入支架后第10.5（5）（均值（标准差））天（罪犯病变：15例左前降支、3例回旋支和2例右冠状动脉），20例患者（均值（标准差）60.4（11.4）岁）在低电压区使用EMM引导的经皮心肌内注射接受骨髓来源的单个核细胞。15例患者在6个月随访时进行了EMM和冠状动脉造影。所有20例患者均进行了超声心动图检查、实验室数据记录及临床评估（6个月和12个月随访）。
所有患者均未出现围手术期并发症。3例患者接受了植入式心脏复律除颤器用于心脏性猝死的一级预防，6例（30%）患者出现支架内再狭窄。1例患者在6个月后因慢性支架闭塞接受了搭桥手术。每位患者注射了2.0（0.6）×10⁸个细胞，包括1.0（0.3）×10⁶个CD45（dim）/CD34（hi）干细胞。EMM显示单极电压从基线时正常电压的45.5（14.3）%平均（标准差）改善至59.3（19.8）%（p = 0.002），低电压区从28.7（12.1）%减少至20.3（13.5）%；（p = 0.016）。在12个月随访期间，左心室射血分数（LVEF）从40.8（6.9）%提高至47.1（10.6）%；（p = 0.037）。
AMI患者的左心室EMM及经皮心肌内细胞注射显示是一种安全的操作。12个月随访后其与LVEF及机电参数改善相关。
Eudra-CT-No 2005-003629-19。
