The 50/50 cc Total Artificial Heart Trial: Extending the Benefits of the Total Artificial Heart to Underserved Populations.

Abstract

While use of the total artificial heart (TAH) is growing, the use of the device is not uniform across the gender and age spectrum because the vast majority of implants are in adult males. SynCardia has recently developed a smaller 50 cc TAH that was designed to accommodate patients with a body surface area as low as 1.2 m2 (potentially even lower using virtual implantation). Herein, we describe the early use of the 50 cc TAH (10 implants in the US and 18 outside the US). Twenty-eight devices have been implanted worldwide. Nineteen (68%) patients were female, 4 (14%) were 21 years of age or younger, and 2 (7%) had a diagnosis of congenital heart disease (1 Fontan). The smallest patient, by body surface area, was 1.35 m2. Six patients (21%) have been placed on the Freedom Driver, all of whom have survived. Fourteen patients (50%) have had a positive outcome to date. The development of the 50 cc TAH has expanded the population of patients who may benefit from TAH support and thus may help improve outcomes for patients who have had limited biventricular support options to date.