Abstract 19135: Safety and Efficacy of Intramyocardial Delivery of Stem Cells in Ischemic Heart Failure: An Individual Patient Data-Based Meta-Analysis
Background. Intramyocardial stem cell delivery mode might be the choice for regeneration of chronic myocardial ischemia and/or left ventricular (LV) dysfunction.
Methods. Individual patient data-based meta-analysis includes data of 383 patients (part of MESS database, clinicaltrials.gov NCT01098591) with ischemic cardiomyopathy (iCMP) and treated either with autologous stem cell (SC) (bone marrow mononuclear or mesenchymal stem cells) using percutaneous 3D NOGA-guided delivery (n=290) or randomized to controls (n=93), data received from 5 European centers.
Results. The average follow-up (FUP) was 6.4±2.2 months. The baseline end-diastolic volume (189±73 ml vs 201±71 ml) and ejection fraction (EF) (41.4±14.5% vs 42.5±18.7%) were similar in SC treated vs controls. Procedural complication occurred in 2.1% of patients, and 80.8x10^6 cells were delivered in 11.2±2.5 myocardial sites. Compared with controls, intramyocardial delivery of SC improved (p<0.001) LV EF (mean difference 4.6%; 95% confidence interval /CI/ 6.4% to 2.7%); reduced infarct size (-2.22%; 95% CI -3.54% to -0.90%) and size of stress-induced myocardial ischemia (-5.6; 95% CI -7.38% to -3.88%). The CCS angina status (-1.0; 95% CI -0.68 to -1.06) and NYHA (-0.74; 95% CI -0.54 to -0.93) improved significantly (p<0.001) post SC therapy as compared with controls. Kaplan-Meier analysis resulted in a significant better survival (98.8% vs 93.5%, p<0.01) and MACCE-free survival (97.9% vs 78.5%, p<0.001) rate in SC-treated patients vs controls. Multivariate analysis resulted in a lower baseline EF and higher total number of intramyocardial delivered SC as significant predictors for improvement in EF, while norminal regression analysis revealed SC therapy as significant predictor for MACCE-free survival in patients with iCMP.
Conclusion. Meta-analysis of 3D NOGA endocardial mapping guided transendocardial stem cell treatment proves the safety and efficacy of this cardiac regeneration strategy in patients with chronic ischemia and low EF.
- © 2012 by American Heart Association, Inc.