Abstract

The SynCardia Total Artificial Heart (TAH) is a pneumatically driven assist system to provide mechanical circulatory support in patients with severe non-reversible biventricular failure, who otherwise have no mechanical support devices. The aim of our retrospective study is to assess the comorbidity and survival of patients awaiting cardiac transplant while circulatory support with TAH. We examined data related to survival, adverse events, and outcomes from patients undergoing TAH implantation between Januar 2001 and September 2019. For determination of the predictors for mortality we used multivariate analysis. Between February 2001 and September 2019, a total of 190 consecutive patients (88.9% men; mean age, 53±11.6 years,) underwent TAH implantation. Indications for TAH implantation were cardiomyopathy in 84 (44.2%), acute myocardial infarction in 50 (26.3%) and postcardiotomy biventricular heart failure in 29 (15.3%) and others (allograft rejection, myocarditis, endocarditis, congenital heart disease) in 27 patients (14.2%). The majority of patients (166/87.4%) were in INTERMACS profile 1, the remainder (24/12.7%) in INTERMACS profiles 2-3. Preoperative measures of the creatinine was 2.0±1.3 mg/dl and total bilirubin 3.0±3.8 mg/dl. The median support time was 169 days (range, 1 to 971 days). During TAH support, 32.1% of patients suffered from stroke, 30.5% from mesenteric ischemia and 24.2% from gastrointestinal bleeding. The median follow-up for survival of patients on support was 4.3 months. The 1-, 6- and 12-month survival was 71%, 42% and 35%, respectively. A total of 120 (63.2%) patients died during support. The most common causes of the death were multiorgan failure or/with sepsis. Multivariate analysis revealed that age p=0.003), underweight with BMI <18.5 kg/m² (p=0.001), higher total bilirubin (p=0.007) and preoperative IABP (p=0.013) were independent predictors for mortality during support. Sixty-nine (35.3%) were successfully bridged to transplantation after a mean support time of 311±205 days. 1-, 5- and 10-year survival was 64%, 58% and 51%, respectively. SynCardia TAH provides acceptable outcomes in critically sick patients with irreversible heart failure who are candidates for cardiac transplantation. More than one third of our TAH-patients were be successfully bridged to transplantation.

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