Myocardial Repair by Percutaneous Cell Transplantation of Autologous Skeletal Myoblast as a Stand-Alone Procedure in Post-Myocardial Infarction Chronic Heart Failure Patients - Myocardial Repair by Percutaneous Cell Transplantation of Autologous Skeletal Myoblast as a Stand-Alone Procedure in Post-MI CHF Patients

Description:

The goal of the study was to evaluate the feasibility and safety of percutaneous cell transplantation of autologous skeletal myoblast as a stand-alone procedure in post-myocardial infarction (MI) chronic heart failure (CHF) patients.

Study Design

Patients Enrolled: 15
Mean Follow Up: One year
Mean Patient Age: Mean age 63 years
Female: 7
Mean Ejection Fraction: Mean baseline ejection fraction 29%

Patient Populations:

Symptomatic heart failure patients with New York Heart Association class ≥2, previous anterior wall MI ≥4 weeks at time of transplantation, LV ejection fraction 20-45%, and no contractile reserve during dobutamine stress echo

Exclusions:

History of syncope, sustained ventricular tachycardia or fibrillation, or target regional wall thickness <5 mm

Drug/Procedures Used:

Patients underwent percutaneous transendocardial skeletal myoblast injection as a stand-alone procedure using a NOA or fluoroscopy-guided injection catheter. An average of 18 injections were performed on each patient, with 15 million cells per injection. Patients were monitored with Holter, ECG tests, stress echocardiography, and left ventricular (LV) angiography.

Principal Findings:

Mean baseline ejection fraction was 29%, and 87% were treated with angiotensin-converting enzyme inhibitors. An average of 215 million cells were injected, with cell viability of 96%. The mean time post-MI was six years.

The first six patients enrolled in the study did not have an implantable cardiac defibrillator (ICD), as this was initially an exclusion criterion. Among those six initial patients, three patients had an event, one ventricular tachycardia, one nonsustained ventricular tachycardia, and one death. As a result of these events, the study was modified to require ICD implantation as an inclusion criterion. Nine patients were subsequently enrolled with an ICD, five of whom had an event (one tachycardia, one nonsustained ventricular tachycardia, one nonsustained ventricular tachycardia/ventricular tachycardia, one arrhythmia, and one slow ventricular tachycardia).

There was no difference in change from baseline to 12 months in ejection fraction (34.4% at baseline vs. 36.6% at 12 months, p=0.26), end diastolic volume (238 ml vs. 219 ml), or end systolic volume (158 ml vs. 143 ml, p=0.56). Wall motion score index was lower at follow-up compared with baseline both at rest (3.04 vs. 2.75, p=0.049) and at low-dose dobutamine stress (2.77 vs. 2.46, p=0.07). Additionally, New York Heart Association class improved from 2.8 at baseline to 1.8 at one year.

Interpretation:

Among post-MI CHF patients, percutaneous cell transplantation of autologous skeletal myoblast as a stand-alone procedure was feasible, but was associated with a large number of ventricular arrhythmias. Eight of the 15 patients in the trial had some type of ventricular disturbance. There were improvements in wall motion and New York Heart Association class suggesting potential efficacy; however, the safety of the procedure is questionable.

The safety results differ somewhat from the POZNAN study, where only one of the nine patients had an arrhythmia. The overall number of patients enrolled in both studies is small.

References:

Smits PC, Nienaber C, Colombo A, et al. Myocardial repair by percutaneous cell transplantation of autologous skeletal myoblast as a stand alone procedure in post myocardial infarction chronic heart failure patients. EuroIntervention. 2006 Feb;1(4):417-24.

Presented by Dr. Patrick W. Serruys at the March 2005 ACC Annual Scientific Session, Orlando, FL.

Clinical Topics: Arrhythmias and Clinical EP, Heart Failure and Cardiomyopathies, Noninvasive Imaging, Implantable Devices, SCD/Ventricular Arrhythmias, Acute Heart Failure, Echocardiography/Ultrasound, Nuclear Imaging

Keywords: Fluoroscopy, Myocardial Infarction, Follow-Up Studies, Echocardiography, Stress, Cell Transplantation, Dobutamine, Myoblasts, Skeletal, Heart Failure, Accelerated Idioventricular Rhythm, Cell Survival, Defibrillators, Implantable


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