P950Intramyocardial bone marrow mononuclear cell injection in patients with ischemic heart disease: a safety evaluation of 333 procedures

Abstract

Background: Cardiac cell therapy has been introduced as a novel treatment option for ischemic heart disease patients. Previously, we demonstrated in a RCT that intramyocardial bone marrow mononuclear cell (BMC) injection improves myocardial perfusion in no-option patients with refractory angina pectoris (RAP). Since 2010 this procedure is a standardized treatment for refractory angina patients with myocardial ischemia without options for revascularization. Methods: We assessed 333 patients (age 63±10years, male 88%) who underwent intramyocardial injection of BMC, mesenchymal stromal cells or placebo injection between 2005 and 2017, using the NOGA system. Periprocedural and 1 year follow-up adverse events were noted. Major events were defined as an additional intervention or a prolonged hospitalisation. Results: The patients treated for RAP showed improved Canadian Cardiovascular Society score from 3.1±0.6 at baseline to 2.2±0.7 at 3 months (P<0.001) whereas quality-of-life improved by22% (P<0.001). There were no fatalities as a result of the procedure. Indication for injection was RAP (n=289), ischemic heart failure (n=35), acute myocardial infarction (n=9). In 39 patients (11.7%) a procedural complication occurred. Of which 43,6% was defined as major event. Those existed of 3 patients with a stroke; 1 during the procedure, 1 several hours after the procedure and 1 patient had a transient ischemic attack. Six patients had a spurious aneurysm needing an intervention. Two patients had a periprocedural myocardial infarction and 2 had an asthma cardiale. One patient had pericardial effusion requiring pericardiocentesis, 1 had a ventricular tachycardia followed by electric cardioversion and 1 patient had an abdominal aortic dissection. In 4 patients the cell material was aggregated and couldn't be used. During 1 year follow-up no additional adverse events were observed. Conclusion: Intramyocardial cell injection is relatively save, and associated with sustained improvements of anginal complaints in no-option refractory angina patients.