Purpose: The pneumatic pulsatile Total Artificial Heart (TAH) has emerged as an effective, life-saving means of bridging-to-transplantation (BTT) patients at imminent risk of death from biventricular failure. On the TAH, patients typically recover rapidly, becoming ambulatory. The initial configuration of the TAH system has required patients to remain in the hospital tethered to a large, heavy pneumatic driver (CSS console), with limited mobility. Recently, a new, portable (13 lb) electromechanical driver (EMD) has been developed to provide mobile pneumatic power for the TAH, affording patients complete ambulatory freedom. We hypothesized that the EMD would operate within the specification of the CSS, providing adequate drive power, allowing successful discharge from the hospital and eventual transplantation. We report on the fi rst cohort of patients to complete the trial.
Methods: TAH patients stable on the CSS were transitioned to the EMD. Efficacy success indicators include: 1. A Cardiac Index (CI) on EMD averaging >2.2 L/min/m2 throughout 90 days, and 2. Clinical outcomes.
Results: 13 patients (11 male) were successfully transitioned and maintained on EMD. Mean CI was 3.0 ± 0.9. Total time on EMD was 1,520 days with 116.9 days on avg. (1-442 day range). 8/13 patients were discharged home. All patients met the overall pre-specifi ed success of maintenance on EMD for 90 days (7/13 patients) or Tx (6/13 patients) within that period. Clinical outcomes were Tx (12/13 patients) or death post-90 day discharge (1/13 patients).
Conclusions: Using a portable EMD, TAH patients are increasingly mobile, allowing discharge from the hospital with successful bridge to transplantation, while residing in a home environment.