Efficiency of Intramyocardial Injections of Autologous Bone Marrow Mononuclear Stem Cells in Patients with Ischemic Heart Failure: Long-Term Results

Abstract

Introduction: Intramyocardial injection of autologous bone marrow mononuclear cells (BMMC) is believed to be a promising method for the treatment of patients with chronic ischemic heart disease. Hypothesis: To evaluate long-term results of intramyocardial bone marrow cell injection in patients with severe ischemic heart failure. Methods: Ninety nine ischemic heart failure patients (age 58 ± 5) with left ventricle ejection fraction (LVEF) ≤35% and III-IV NYHA and CCS functional classes without possibility for conventional revascularization were randomized into two groups: 1 group (n=49) - received intramyocardial BMMC injection and patients of the second group (n=50) were treated with standard medical therapy for HF. The NOGA system was used to administer 4.9 x107 BMMC into the infarction border zone. We analyzed all clinical data at 6 and 12 month of the follow-up period. Results: None of the patients developed periprocedural complications following BMMC injections. In the first group, the injections led to improvement of CCS class (3.5 ± 0.5 vs 2.1 ± 0.6 after 6 months and 1.9 ± 0.6 after 12 months (p<0.05 vs. baseline) and NYHA functional class (3.4 ± 0.1 vs 2.3 ± 0.2 after 6 months and 2.0 ± 0.2 after 12 months; p<0.05). The same characteristics in patients of the 2 group therapy remained unaltered (p = NS). LVEF increased in group 1 (34 ± 2% vs 42 ± 3%; p<0.05) while it tended to decrease in the control group (34 ± 2% vs 31 ± 3%; p = NS). Summed rest score improved in the first group after 6 months (14.7 ± 5.4 vs 10.7 ± 4.9; p<0.05). The improvement of stress score was more noticeable (18.2 ± 5.4 vs 9.4 ± 4.2; p<0.05). Neither stress nor rest score changed in patients of the second group. At the moment after 12 month follow up period 5 patients (10.2%) from group 1 died compared with 14 patients (28%) from group 2 (log rank test, p=0.008). Conclusions: Intramyocardial injection of autologous bone marrow mononuclear cells in ischemic heart failure patients is a safe procedure that improves clinical symptoms and has beneficial effecton LV function.