Abstract
The recent successful clinical applications of AbioCor TAH in 5 end-stage cardiac patients and of VADs such as Novacor, TCI, Lion Heart, DeBakey MicroMed, Jarvik 2000 in over 5000 patients have been extremely encouraging for the treatment of end-stage cardiac patients either bridging to heart transplantation or as a destination therapy. In Japan, since donor heart availability has been extremely limited, the number of heart transplantation to date is only 12 since 1999. Although Novacor and TCI VADs have been imported, their large size and high cost are suppressing their wide clinical use. There is a strong clinical need for a compact, durable, biocompatible, completely implantable, permanent VAD and TAH in Japan. To meet the clinical need in Japan, we have developed compact, electromechanical TAH and VAD intended for 50–60 Kg patients. Special features common to both systems include 1) easily controllable pusher-plate (PP) type pump with 55cc stroke volume, 2) efficient and compact electromechanical actuator comprising of a DC motor and a planetary roller screw, 3) vacuum formed durable polyurethane diaphragm, 4) pump housing made of extremely non-toxic and stable titanium alloy containing 6% Al and 7% Nb, 5) blood contacting surface coated with extremely anti-thrombogenic 2-methacryloyloxyethyl phosphorylcholine (MPC) polymer 5) micro-processor based compact and efficient controller, 6) compact, efficient NiMH rechargeable internal battery, 7) air-filled compliance chamber, and 8) TET system. These features allow anatomically, and blood and tissue compatible, highly efficient and easily controllable, long-term durable completely implant-able VAD and TAH. The TAH's dimensions are 90mm in diameter and 70mm in thickness, yielding the volume and weight of 400cc and 650g, while VAD's dimensions are 90mm and 56mm, giving volume and weight of 275cc and 500g. Both TAH and VAD can provide the maximum flow of 8L/min with the maximum efficiency of 13.5% and 24%). Both systems have been under evaluation in calves since March of 2001. All the procedures have been successfully worked out to produce long-term survivors. These devices can become the base for future development of the advanced circulatory support systems having extremely long durability and excellent biocompatibility through incorporation of technologies such as tissue engineering and regenerative medicine.
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