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Percutaneous Transvenous Transplantation of Autologous Myoblasts in the Treatment of Postinfarction Heart Failure - POZNAN
Description:
The goal of the phase I POZNAN trial was to evaluate safety and feasibility of autologous skeletal myoblast (ASM) transplantation performed with percutaneous transcoronary vein (PTCV) approach in patients with post-myocardial infarction (MI) heart failure.
Hypothesis:
Treatment of post-MI heart failure patients with ASM transplantation performed with PTCV approach will be safe and feasible.
Study Design
Study Design:
Patients Enrolled: 10
Mean Follow Up: Six months
Female: 10
Patient Populations:
Documented MI occurring a minimum of 3 months before the procedure; age <65 years; ejection fraction between 25% to 40%; one to three akinetic or dyskinetic segments on echocardiography and lack of myocardial viability on dobutamine echocardiography; heart failure NYHA class 2 or 3; and good coronary artery blood flow into the area of post-infarction injury as a result of previous revascularization or development of collateral flow.
Exclusions:
Episodes of unstable ischemia after the infarction onset or other causes requiring urgent revascularization; known inflammatory disease; renal insufficiency; history of stroke; peripheral muscular dystrophy.
Primary Endpoints:
Safety and feasibility
Secondary Endpoints:
Ejection fraction (EF) at six months
Drug/Procedures Used:
Patients with presence of an akinetic or dyskinetic post-MI injury with no viable myocardium and good coronary artery blood flow into the injured area were treated with ASM transplantation performed with PTCVs. A biopsy was performed to obtain an ASM specimen and then grown in cell culture.
The procedures were performed using a catheter system enabling intramyocardial injections from the lumen of cardiac veins under intravascular ultrasound guidance.
Concomitant Medications:
Prophylactic amiodarone infusion before and during the procedure
Principal Findings:
The procedure was abandoned in one patient due to the inability to position the catheter across the coronary venous valve, while ASM transplantation was performed in the remaining nine patients using the Trans Access catheter system. Access to the myocardium was performed using injections via the anterior interventricular vein in five patients and via the middle cardiac vein in four patients.
Eight of the nine patients were free from arrhythmia throughout 10-16 days of continuous ECG monitoring. The one patient who did not receive prophylactic amiodarone had episodes of ventricular tachycardia and experienced three shots from his internal defibrillator at day 8 post-procedure.
New York Heart Association classification improved in all nine patients at six-month follow-up. Six of the nine patients also had improvements in ejection fraction of 3-8% at six months.
Interpretation:
Among patients with post-MI heart failure, ASM transplantation performed with the PTCV approach was feasible and safe in this phase I study. Much larger randomized phase 2 and 3 clinical trials will be needed to assess efficacy and a broader safety evaluation.
Data from this study support the initiation of future trials, which could have widespread implications if myocardial regeneration of damaged tissue succeeds in post-MI heart failure patients.
References:
Siminiak T, et al. Percutaneous trans-coronary-venous transplantation of autologous skeletal myoblasts in the treatment of post-infarction myocardial contractility impairment: the POZNAN trial. Eur Heart J. 2005 Jun;26(12):1188-95.
Presented by Dr. Tomasz Siminiak at the American College of Cardiology Annual Scientific Session, March 2004.
Keywords: Defibrillators, Myocardial Infarction, Follow-Up Studies, Biopsy, Electrocardiography, Dobutamine, Tachycardia, Ventricular, Regeneration, Myoblasts, Skeletal, Heart Failure, Venous Valves, Echocardiography
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