Abstract
The Arrow LionHedrt™ LVAS is the first completely implanted blood pump system - utilizing transcutaneous power transmission and an implanted compliance chamber - to be implanted in humans. Clinical trials in 29 patients in Europe and 10 in the US. (23 patient-years) represent the largest clinical experience to date with transcutaneous power transmission. Power is transmitted inductively from an external coil (11.O cm outer dia.) driven by a power transmitter (PT) to an implanted coil (7.3 cm dia.) connected to the implanted controller. The range of coil separation is 2.5 cm axially and 2.0 cm radially. In normal use, the PT is powered by a portable battery pack, or a household or automobile source. An implanted, rechargeable battery allows for up to 45 minutes of external coil removal. Safety systems include alarms for coil dislocation, metal interference, abnormal power levels, and high temperature. The reliability of the PT has been excellent, with no power transmission failures. The preferred internal coil implantation site was moved from the sixth intercostal region to the sub-clavicular location. An improved coil fixation device and coil strain relief were designed. There have been no adverse tissue responses to the coils other than mild early post-operative swelling in some patients. The elimination of percutaneous tubes has resulted in a low incidence of device-related sepsis.
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