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Objective: To determine the feasibility and safety of skeletal myoblast transp lantation in patients with chronic myocardial infarction undergoing coronary art ery bypass grafting. Methods: Twelve patients with a previous myocardial infarct ion and ischemic coronary artery disease underwent treatment with coronary arter y bypass grafting surgery and intramyocardial injection of autologous skeletal m yoblasts cultured with autologous serum. Global and regional cardiac function wa s assessed by echocardiogram. Fluorine 18 fluorodeoxyglucose and nitrogen 13-am monia positron emission tomography studies were used to determine cardiac viabil ity and perfusion. A group of historical control patients(n=14) treated with coronary artery bypass grafting surgery wi thout myoblast transplantation was analyzed. Results: The left ventricular eject ion fraction improved from 35.5%±2.3%(mean±SEM) before surgery to 55.1%±8. 2%at 12 months(P< .01) in the myoblast group and from 33.6%±9.3%to 38.6%±1 1%in the control group. Regional contractility also improved in the myoblast gr oup, particularly in cardiac segments treated with skeletal myoblasts(wall motio n score index: 3.02±0.17 at baseline vs 1.36±0.14 at 12 months; P< .0001). Qua ntitative fluorine 18-fluorodeoxyglucose and nitrogen 13-ammonia positron emis sion tomography showed an increase in viability and perfusion 12 months after su rgery both globally and in segments treated with myoblasts(P=.012 and P=.004). S keletal myoblast implantation was not associated with adverse events or an incre ased incidence of cardiac arrhythmias. Conclusions: In patients with previous my ocardial infarction, treatment with skeletal myoblasts in conjunction with coron ary artery bypass is safe and feasible and is associated with an increased globa l and regional left ventricular function, improvement in viability, and perfusio n of cardiac tissue and no significant incidence of arrhythmias.
Objective: To determine the feasibility and safety of skeletal myoblast transp langeation in patients with chronic myocardial infarction undergoing coronary art ery bypass grafting surgery. Methods: Twelve patients with a previous myocardial infarct and ischemic coronary artery disease underwent treatment with coronary arter y bypass grafting surgery and intramyocardial injection of autologous skeletal m yoblasts cultured with autologous serum. Global and regional cardiac function wa s assessed by echocardiogram. Fluorine 18 fluorodeoxyglucose and nitrogen 13-am monia positron emission tomography studies were used to determine cardiac viabilility and perfusion. A group of Historical control patients (n = 14) treated with coronary artery bypass grafting surgery wi thout myoblast transplantation were analyzed. Results: The left ventricular eject ion fraction improved from 35.5% ± 2.3% (mean ± SEM) before surgery to 55.1% ± 8. 2% at 12 months (P <.01) in the myoblast group and from 33.6% ± 9.3% to 38.6% ± 1 1% in the control group. Regional contractility also improved in the myoblast group, particularly in cardiac segments treated with skeletal myoblasts (wall motio n score index: 3.02 ± 0.17 at baseline vs 1.36 ± 0.14 at 12 months; P <.0001) . Qua ntitative fluorine 18-fluorodeoxyglucose and nitrogen 13-ammonia positron emis sion tomography showed an increase in viability and perfusion 12 months after su rgery both global and in segments treated with myoblasts (P = .012 and P = .004). S keletal myoblast implantation was not associated with adverse events or an incresed incidence of cardiac arrhythmias. Conclusions: In patients with previous my ocardial infarction, treatment with skeletal myoblasts in conjunction with coron ary artery bypass is safe and feasible and is associated with an increased globa l and regional left ventricular function, improvement in viability, and perfusio n of cardiac tissue and no significant incidence of arrhythmias.