Total artificial heart implantation as a bridge to transplantation in the United States.

Objectives: Although the SynCardia total artificial heart (SynCardia Systems, LLC) was approved for use as a bridge to transplantation in 2004 in the United States, most centers do not adopt the total artificial heart as a standard bridging strategy for patients with biventricular failure. This study was designed to characterize the current use and outcomes of patients placed on total artificial heart support.

Methods: The United Network of Organ Sharing Standard Transplant Research File was queried to identify total artificial heart implantation in the United States between 2005 and 2018. Multivariable Cox regression models were used for risk prediction.

Results: A total of 471 patients (mean age, 49 years; standard deviation, 13 years; 88% were male) underwent total artificial heart implantation. Of 161 transplant centers, 11 centers had cumulative volume of 10 or more implants. The 6-month cumulative incidence of mortality on the total artificial heart was 24.6%. The 6-month cumulative incidence of transplant was 49.0%. The 1-year mortality post-transplantation was 20.0%. Cumulative center volume less than 10 implants was predictive of both mortality on the total artificial heart (hazard ratio, 2.2, 95% confidence interval, 1.5-3.1, P < .001) and post-transplant mortality after a total artificial heart bridge (hazard ratio, 1.5, 95% confidence interval, 1.0-2.2, P = .039).

Conclusions: Total artificial heart use is low, but the total artificial heart can be an option for biventricular bridge to transplant with acceptable bridge to transplant and post-transplant survival, especially in higher-volume centers. The observation of inferior outcomes in lower-volume centers raises questions as to whether targeted training, center certifications, and minimum volume requirements could improve outcomes for patients requiring the total artificial heart.