title: Myocardial repair by percutaneous cell transplantation of autologous skeletal myoblast as a stand alone procedure in post myocardial infarction chronic heart failure patients.
abstract: OBJECTIVE
  In this first multicentre study we assessed the safety and efficacy of percutaneous transendocardial skeletal myoblast injection as a stand alone procedure in congestive heart failure patients.
  
  
  RESULTS
  15 patients (14 male), age 63+/-7 (Mean+/-SD), NYHA class 2-4 were injected with 216+/-119 cells (81+/-19% Desmin+) using a NOGA or fluoroscopy guided injection catheter. The cells were injected in the scarred regions 6+/-4 years after myocardial infarction as a stand alone procedure. After treating the first 6 patients, the protocol was amended to require that remaining patients be fitted with an ICD prior to the cellular cardiomyoplasty procedure. Holter monitoring, ECG and ICD readings were obtained at multiple intervals. Stress echocardiography and LV angiography was performed at baseline, 3, 6 and 12 months post procedure.After 1 year follow-up 13 patients were still alive. Patient # 6 died suddenly 9 days post procedure. Patient #15 (ICD patient) survived an electrical storm 12 days post procedure, but died 2 days later due to cardiogenic shock. Two non-ICD patients received an ICD because of observed ventricular arrhythmias. It remains unknown whether these events are directly related to the cell injections.LV ejection fraction (%) changed from 34.4+/-10.3 to 36.6+/-10.4 (baseline versus 12 months FU, p=0.26). Wall motion score index improved both at rest (3.0+/-0.5 to 2.7+/-0.7, p=0.049) and under low-dose dobutamine stress (2.8+/-0.4 to 2.5+/-0.6, p=0.07, baseline versus 12 months FU).
  
  
  CONCLUSIONS
  Percutaneous autologous skeletal myoblast injection is feasible, resulting in wall motion and functional class improvement, but is potentially associated with an increased risk for ventricular arrhythmias. Randomised studies are needed, however, to further assess overall safety, efficacy and the potential for initial increased risk for arrhythmia following cell injection in these high-risk patients.
authors.affiliation: Department of Cardiology, Thorax Center, Erasmus Medical Center, Rotterdam, The Netherlands.
authors.forename: Pieter C
authors.initials: PC
authors.lastname: Smits
authors.forename: Christoph
authors.initials: C
authors.lastname: Nienaber
authors.forename: Antonio
authors.initials: A
authors.lastname: Colombo
authors.forename: Hüseyin
authors.initials: H
authors.lastname: Ince
authors.forename: Mauro
authors.initials: M
authors.lastname: Carlino
authors.forename: Dominique A M J
authors.initials: DA
authors.lastname: Theuns
authors.forename: Elena
authors.initials: E
authors.lastname: Biagini
authors.forename: Marco
authors.initials: M
authors.lastname: Valgimigli
authors.forename: Emile E M
authors.initials: EE
authors.lastname: Onderwater
authors.forename: Paul
authors.initials: P
authors.lastname: Steendijk
authors.forename: Nicholas S
authors.initials: NS
authors.lastname: Peters
authors.forename: Dick M
authors.initials: DM
authors.lastname: Goedhart
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys