Abstract 3712: Procedural Safety and Short-term Outcome of Intracoronary BMC Therapy in 710 Consecutive Patients
Cell-based-therapies are a promising option in patients (pts) with acute or chronic heart failure. However, administration of cells requires intracoronary (IC) or intracardiac instrumentation potentially associated with procedural risks. Thus, we analyzed procedural complications and 30-days outcome of all pts receiving IC administration of bone marrow-derived progenitor cells (BMC) using the stop-flow technique between 2001 and 2008 in our monocentric trials and in an ongoing registry at a single center.
Results: A total of 710 procedures were performed in 497 pts (age 60+/−12 years; 14% women). Indication for BMC treatment was acute myocardial infarction (AMI, n=86), ischemic cardiomyopathy (ICM, n=566) or dilated cardiomyopathy (DCM, 58). In ischemic pts (AMI, ICM), BMCs were injected into the infarct-related artery (LAD 62%, RCX 12%, RCA 26% or ACVB in 0.6%), whereas the LAD was the target vessel in all DCM pts. Balloon-induced vessel occlusion time was 7.97±1.96 min. Concomitant revascularization of any vessel was performed in 11.6% of AMI, 23.9% of ICM and in none of the DCM pts. Vessel injuries following BMC administration leading to additional PCI were rare (3 vessel and 2 side branch occlusions, 3 embolizations, 1 IC thrombus, and 7 non flow-limiting dissections). None of the events occurred in DCM pts, 3 complications occurred in AMI pts (3.5%) and 13 occurred in the ICM group (2.3%). A significant increase in troponin T (>0.02ng/dl) was observed in 9.7% of ICM and in 4.9% of DCM pts 24 hours after treatment. Predictors of troponin T increase by univariate analysis were increased age, periprocedural vessel injury, concomitant revascularization, NYHA class, reduced LVEF, elevated creatinine, and PAOD or insulin-treated diabetes (all p<0.05). However, by multivariate analysis, only concomitant PCI (p=0.036) and periprocedural vessel injury (p<0.001) were independent significant predictors of troponin T increase. During the first 30 days after treatment, 2 deaths (1 AMI, 1 ICM) and 1 stroke (ICM) occurred.
Conclusions: IC infusion of BMC can be performed with adequate safety in pts with AMI or chronic heart failure. The observed complications are predominantly related to concomitant interventional procedures in pts with ischemic heart disease.