Impact of Bleeding Complications on Outcomes Following Total Artificial Heart Implantation

Abstract

Bleeding complications are well recognized phenomena following left ventricular assist device (LVAD) implantation and have been associated with increased morbidity and mortality. This complication and its consequences, however, remain undefined for total artificial heart (TAH) implantation. A prospectively maintained database was used to identify all patients receiving TAH from January 2012 to May 2019 at a single institution. Baseline demographics and outcomes were retrospectively reviewed. The INTERMACS definition of major bleeding was used for stratification. Ninety-three patients underwent TAH implantation (age 50.0 ± 12.8, male 82.8%) between January 2012 and May 2019. The predominant cardiac diagnoses were idiopathic dilated cardiomyopathy (n=39, 41.9%), ischemic dilated cardiomyopathy (n=23, 24.7%), and restrictive cardiomyopathies (n=14, 15.1%). Most patients were INTERMACS profiles 1 and 2 (53% and 31%, respectively). The overall survival was 62.4%, with a median follow-up of 1.5 years [0.1, 4.2]. Fifty-six patients (60.2%) were successfully bridged to transplantation, with 1-year post-transplant survival of 91.1%. Thirty-four patients (36.6%) experienced major bleeding. There were no significant differences in baseline demographics, disease etiology, or INTERMACS profiles between the bleeding and non-bleeding cohorts. A trend towards increased overall mortality (HR 1.54 [0.84-2.81], p=0.143) and decreased rates of transplantation (50% vs 66%, p=0.185) were noted in the major bleeding cohort. Post-transplant survival at 1-year were 82.4% and 94.9% in the bleeding and non-bleeding cohorts, respectively (p=0.158). Three rejection episodes (17.6%) were noted in the bleeding cohort and 6 (15.4%) in the non-bleeding cohort (p>0.999). Major bleeding events occurred in over one-third of patients undergoing TAH implantation. This complication, however, did not appear to significantly impact survival or allograft rejection rates.