Long-Term Outcome of Intra-Myocardial Injection of Autologous Bone Marrow Mononuclear Cells Combined with Isolated Coronary Artery Bypass Grafting for Patients with Chronic Ischemic Heart Failure.

Abstract

This study aimed to investigate whether intra-myocardial injection of autologous bone marrow mononuclear cells (aBMMNCs) into peri-scarred myocardium during coronary artery bypass grafting (CABG) improved the long-term outcome compared with CABG alone. From April 2011 to December 2012, 33 patients with chronic ischemic heart failure were randomly assigned to undergo CABG (control group) or CABG combined with intra-myocardial injection of aBMMNCs (treatment group). The primary endpoints of the study were the changes of left ventricular ejection fraction (LVEF), left ventricular end-diastolic volume (LVEDV), and left ventricular end-systolic volume (LVESV) from baseline to six-month and two-year follow-up, respectively. The secondary endpoints were the changes of III and IV NYHA classification, 6-minute walk test, B-type natriuretic peptide (BNP) from baseline to follow-up, and major adverse cardiovascular events (MACES) during the follow-up. No patient died and no severe surgical complication occurred perioperatively in either group. The mean number of transplanted aBMMNCs was 98.5 ± 48.3×106 per patient. The follow-up was completed at six months and 24 months postoperatively. No major transplant-related adverse events were detected during the study. The patients in the treatment group had more significant improvement in LVEF than in the control group at six-month follow-up (8.17% versus 4.71%, P = .020), but this benefit was not found at 24-month follow-up (7.44% versus 5.69%, P = .419). There was no significant difference in changes of LVEDV, LVESV, III and IV NYHA classification, 6-minute walk distance, BNP, and MACES between the two groups all through the study. Intra-myocardial injection of aBMMNC transplantation on arrested heart during CABG is a safe procedure based on a longer period observation. The patients with chronic ischemic heart failure can benefit from aBMMNCs transplantation in the short-term (6 months) demonstrated by improved global LVEF compared with the control group; however, this additional benefit dimed with time as showed by 24-month clinical and echocardiographic follow-up results.