Versatile one-piece total artificial heart for bridge to transplantation or permanent heart replacement

A versatile, one-piece total artificial heart (TAH) system that can be driven by either an electromechanical acutator (EM-TAH) or a pneumatic source (P-TAH) has been developed. The common units for both TAHs are the conically shaped left and right pusher-plate-type pumps (63 ml SV) that sandwich a thin centerpiece (18 mm) having a respective actuator. The EM actuator, mounted in the middle of the centerpiece, consists of a direct-current brushless motor and a roller screw while the pneumatic actuator consists of a low-pressure air source. The outer diameter of the pumping unit is 97 mm with its central thickness being 82 mm; overall volume is 510 cc. The TAH is operated in the left master alternative ejection mode with the left pump fill signal. High-flex-life Hexsyn rubber is used as the diaphragm, and the blood-contacting surface is coated with dry gelatin. The TAH can provide 3-8 L/min flow with a preload of 1-10 mm Hg against 100 mm Hg afterload. Anatomical fit of the pumping unit has been demonstrated in the pericardial space of 26 heart transplant recipients with average body weight of 78 kg. To date, 2 P-TAH and 4 EM-TAH (1 week) implantations were performed in 80-100 kg calves demonstrating excellent anatomical fit, controllability, and biocompatibility. This versatile TAH is suitable for a bridge to transplantation or permanent heart replacement.