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(Circulation. 2006;114:I-108 – I-113.)
© 2006 American Heart Association, Inc.

Cell Transplantation and Tissue Engineering

Skeletal Myoblast Transplantation in Ischemic Heart Failure

Long-Term Follow-Up of the First Phase I Cohort of Patients

Albert A. Hagège, MD, PhD; Jean-Pierre Marolleau, PhD; Jean-Thomas Vilquin, PhD; Armelle Alhéritière, MD; Séverine Peyrard; Denis Duboc, MD; Eric Abergel, MD, PhD; Emmanuel Messas, MD, MSc; Elie Mousseaux, MD; Ketty Schwartz, PhD; Michel Desnos, MD; Philippe Menasché, MD, PhD

From Université Paris-Descartes (A.A.H., A.A., E.A., E.M., E. Mousseaux, M.D., P.M), Faculté de Médecine; INSERM U 633, Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Departments of Cardiology, Imaging and Cardiovascular Surgery, Paris, France; Assistance Publique Hôpitaux de Paris (J.-P.M.), Hôpital Saint-Louis, Cell therapy laboratory, Paris, France; INSERM U 582 (J.-T.V., K.S.), Institut de Myologie, Paris, France; INSERM (S.P.), Clinical Investigation Center 92010, Paris, France; Université Paris-Descartes (D.D.), Faculté de Médecine, Assistance Publique Hôpitaux de Paris, Hôpital Cochin, Department of Cardiology, Paris, France.

Correspondence to Albert A. Hagège, Cardiology Department, Hôpital Européen Georges Pompidou, 20 Rue Leblanc, 75015 Paris, France. E-mail albert.hagege{at}egp.ap-hop-paris.fr

Background— Skeletal myoblast (SM) transplantation (Tx) in a post-myocardial infarction (MI) scar experimentally improves left ventricular (LV) ejection fraction (EF). Short-term follow-up (FU) studies have suggested that a similar benefit could clinically occur despite an increased risk of LV arrhythmias.

Methods and Results— We report the long-term FU of the first worldwide cohort of grafted patients (n =9, 61.8±11.6 years, previous MI, EF 35%) operated on (autologous SM Tx and bypass surgery) in 2000 to 2001 and evaluated before Tx, at 1 month (M1) and at a median FU of 52 (18 to 58) months after Tx (37 patient-years). NYHA class improved from 2.5±0.5 to 1.8±0.4 at M1 (P=0.004 versus baseline) and 1.7±0.5 at FU (P=not significant versus M1; P=0.0007 versus baseline). EF increased from 24.3±4% to 31±4.1% at M1 (+28%, P=0.001 versus baseline) and remained stable thereafter (28.7±8.1%, +18% versus baseline). There were 5 hospitalizations for heart failure in 3 patients at 28.6±9.9 months, allowing implant in 2 patients with a resynchronization pacemaker. An automatic cardiac defibrillator (ACD) was implanted in 5 patients for nonsustained (n =1) or sustained (n =4) ventricular tachycardia at 12.2±18.6 (1 to 45) months. Despite a beta-blocker/amiodarone combination therapy, there were 14 appropriate shocks for 3 arrhythmic storms in 3 patients at 6, 7, and 18 months after ACD implantation.

Conclusions— In this cohort of severe heart failure patients both clinical status and EF stably improve over time with a strikingly low incidence of hospitalizations for heart failure (0.13/patient-years) and the arrhythmic risk can be controlled by medical therapy and/or on-request ACD implantation.

Key Words: follow-up studies • heart failure • myocardial infarction • skeletal myoblasts • transplantation