title: Skeletal myoblast transplantation in ischemic heart failure: long-term follow-up of the first phase I cohort of patients.
abstract: 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.
  
  
  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 < or = 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.
authors.affiliation: Université Paris-Descartes, Faculté de Médecine, Paris, France. albert.hagege@egp.ap-hop-paris.fr
authors.forename: Albert A
authors.initials: AA
authors.lastname: Hagège
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Marolleau
authors.forename: Jean-Thomas
authors.initials: JT
authors.lastname: Vilquin
authors.forename: Armelle
authors.initials: A
authors.lastname: Alhéritière
authors.forename: Séverine
authors.initials: S
authors.lastname: Peyrard
authors.forename: Denis
authors.initials: D
authors.lastname: Duboc
authors.forename: Eric
authors.initials: E
authors.lastname: Abergel
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Messas
authors.forename: Elie
authors.initials: E
authors.lastname: Mousseaux
authors.forename: Ketty
authors.initials: K
authors.lastname: Schwartz
authors.forename: Michel
authors.initials: M
authors.lastname: Desnos
authors.forename: Philippe
authors.initials: P
authors.lastname: Menasché
mesh_terms: D000319:Adrenergic beta-Antagonists / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D000638:Amiodarone / Q000627:therapeutic use; D002921:Cicatrix / Q000473:pathology / Q000601:surgery; D015331:Cohort Studies; D003131:Combined Modality Therapy; D017147:Defibrillators, Implantable; D005500:Follow-Up Studies; D006333:Heart Failure / Q000000981:diagnostic imaging / Q000188:drug therapy / Q000209:etiology / Q000601:surgery*; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D008297:Male; D008875:Middle Aged; D018482:Muscle, Skeletal / Q000166:cytology; D032446:Myoblasts / Q000637:transplantation*; D009203:Myocardial Infarction / Q000150:complications / Q000473:pathology / Q000601:surgery; D017202:Myocardial Ischemia / Q000150:complications / Q000601:surgery*; D011183:Postoperative Complications / Q000188:drug therapy / Q000517:prevention & control / Q000628:therapy; D013318:Stroke Volume; D017180:Tachycardia, Ventricular / Q000188:drug therapy / Q000517:prevention & control / Q000628:therapy; D014182:Transplantation, Autologous; D016896:Treatment Outcome; D014463:Ultrasonography
chemical_list: D000319:Adrenergic beta-Antagonists; D000638:Amiodarone