OBJECTIVES: Short-term follow-up after autologous skeletal myoblasts (ASM) transplantation (Tx) (Myoblast Autologous Grafting in Ischaemic Cardiomyopathy (MAGIC) Phase II Study) for the treatment of ischaemic cardiomyopathy revealed improved left ventricular (LV) remodelling. Our study reports the longest long-term worldwide follow-up of a single-centre cohort, focusing on the safety and efficacy of ASM-Tx. METHODS: The multicentre MAGIC Phase II Study involved 120 patients and was conducted between 2004 and 2006. Out of the 120 patients involved in the entire study, the cohort treated at our institution contained 7 patients only. These 7 patients received ASM-Tx (injection volume: 400 million cells, n = 2 low dosage; 800 million cells, n = 2 high dosage) or placebo (n = 3) injections, in addition to coronary artery bypass grafting (CABG). After closure of the MAGIC registry, we conducted a long-term follow-up for our 7-patient cohort. The mean follow-up was 72.0 ± 5.3 months. The follow-up was complete for echo data, implanted cardioverter defibrillator (ICD) report, clinical investigation and New York Heart Association (NYHA) class. RESULTS: At final follow-up, all the patients were alive, and 5 were in NYHA class 1 or 2. There were 6 hospitalizations for congestive heart failure during the follow-up (1 patient from each group). One patient (placebo group) was treated twice for ventricular fibrillation by the ICD. The LV ejection fraction remained stable in all the three groups (31.1 ± 3.9% preoperative vs 29.4 ± 4.4% at final follow-up). The LV volumes were reduced in the high-dosage group, remained unchanged in the low-dosage group and deteriorated in the placebo group. CONCLUSIONS: Our long-term data confirm the findings of the MAGIC study. The LV function did not improve, but the long-term LV volumes in the high-dosage group were reduced. During the follow-up, there were also no additional arrhythmogenic incidences. Our data could imply that CABG in combination with ASM-Tx is safe and has beneficial therapeutic effects in the long-term. However, due to the small patient number, the clinical impact is limited.
RCT Entities:
OBJECTIVES: Short-term follow-up after autologous skeletal myoblasts (ASM) transplantation (Tx) (Myoblast Autologous Grafting in Ischaemic Cardiomyopathy (MAGIC) Phase II Study) for the treatment of ischaemic cardiomyopathy revealed improved left ventricular (LV) remodelling. Our study reports the longest long-term worldwide follow-up of a single-centre cohort, focusing on the safety and efficacy of ASM-Tx. METHODS: The multicentre MAGIC Phase II Study involved 120 patients and was conducted between 2004 and 2006. Out of the 120 patients involved in the entire study, the cohort treated at our institution contained 7 patients only. These 7 patients received ASM-Tx (injection volume: 400 million cells, n = 2 low dosage; 800 million cells, n = 2 high dosage) or placebo (n = 3) injections, in addition to coronary artery bypass grafting (CABG). After closure of the MAGIC registry, we conducted a long-term follow-up for our 7-patient cohort. The mean follow-up was 72.0 ± 5.3 months. The follow-up was complete for echo data, implanted cardioverter defibrillator (ICD) report, clinical investigation and New York Heart Association (NYHA) class. RESULTS: At final follow-up, all the patients were alive, and 5 were in NYHA class 1 or 2. There were 6 hospitalizations for congestive heart failure during the follow-up (1 patient from each group). One patient (placebo group) was treated twice for ventricular fibrillation by the ICD. The LV ejection fraction remained stable in all the three groups (31.1 ± 3.9% preoperative vs 29.4 ± 4.4% at final follow-up). The LV volumes were reduced in the high-dosage group, remained unchanged in the low-dosage group and deteriorated in the placebo group. CONCLUSIONS: Our long-term data confirm the findings of the MAGIC study. The LV function did not improve, but the long-term LV volumes in the high-dosage group were reduced. During the follow-up, there were also no additional arrhythmogenic incidences. Our data could imply that CABG in combination with ASM-Tx is safe and has beneficial therapeutic effects in the long-term. However, due to the small patient number, the clinical impact is limited.
Authors: Rafael Vidal-Perez; Fernando Otero-Raviña; Manuel Franco; José M Rodríguez Garcia; Rosa Liñares Stolle; Ramona Esteban Alvarez; Cristina Iglesias Díaz; Elena Outeiriño López; María José Vázquez López; José Ramón Gonzalez-Juanatey Journal: Int J Cardiol Date: 2012-02-02 Impact factor: 4.164
Authors: Arthur J Moss; Wojciech Zareba; W Jackson Hall; Helmut Klein; David J Wilber; David S Cannom; James P Daubert; Steven L Higgins; Mary W Brown; Mark L Andrews Journal: N Engl J Med Date: 2002-03-19 Impact factor: 91.245
Authors: Daniel Levy; Satish Kenchaiah; Martin G Larson; Emelia J Benjamin; Michelle J Kupka; Kalon K L Ho; Joanne M Murabito; Ramachandran S Vasan Journal: N Engl J Med Date: 2002-10-31 Impact factor: 91.245
Authors: Philippe Menasché; Albert A Hagège; Jean-Thomas Vilquin; Michel Desnos; Eric Abergel; Bruno Pouzet; Alain Bel; Sorin Sarateanu; Marcio Scorsin; Ketty Schwartz; Patrick Bruneval; Marc Benbunan; Jean-Pierre Marolleau; Denis Duboc Journal: J Am Coll Cardiol Date: 2003-04-02 Impact factor: 24.094
Authors: P Menasché; A A Hagège; M Scorsin; B Pouzet; M Desnos; D Duboc; K Schwartz; J T Vilquin; J P Marolleau Journal: Lancet Date: 2001-01-27 Impact factor: 79.321
Authors: Frank Grothues; Gillian C Smith; James C C Moon; Nicholas G Bellenger; Peter Collins; Helmut U Klein; Dudley J Pennell Journal: Am J Cardiol Date: 2002-07-01 Impact factor: 2.778