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.

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 < 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: Albert A Hagège, Jean-Pierre Marolleau, Jean-Thomas Vilquin, Armelle Alhéritière, Séverine Peyrard, Denis Duboc, Eric Abergel, Emmanuel Messas, Elie Mousseaux, Ketty Schwartz, Michel Desnos, Philippe Menasché
• Journal: Circulation (Circulation) Vol. 114 Issue 1 Suppl Pg. I108-13 (Jul 04 2006) ISSN: 1524-4539 [Electronic] United States
• PMID: 16820558 (Publication Type: Clinical Trial, Phase I, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Adrenergic beta-Antagonists
• Amiodarone

Topics

• Adrenergic beta-Antagonists (therapeutic use)
• Adult
• Aged
• Amiodarone (therapeutic use)
• Cicatrix (pathology, surgery)
• Cohort Studies
• Combined Modality Therapy
• Defibrillators, Implantable
• Follow-Up Studies
• Heart Failure (diagnostic imaging, drug therapy, etiology, surgery)
• Hospitalization (statistics & numerical data)
• Humans
• Male
• Middle Aged
• Muscle, Skeletal (cytology)
• Myoblasts (transplantation)
• Myocardial Infarction (complications, pathology, surgery)
• Myocardial Ischemia (complications, surgery)
• Postoperative Complications (drug therapy, prevention & control, therapy)
• Stroke Volume
• Tachycardia, Ventricular (drug therapy, prevention & control, therapy)
• Transplantation, Autologous
• Treatment Outcome
• Ultrasonography