Abstract
Mechanical circulatory support devices experience a wide range of operating conditions during patient use. Since its first implant in June 2000, the Jarvik 2000 left ventricular assist device has witnessed systematic stepwise modifications to reduce the risk of serious adverse events and improve patient outcomes. Over time, clinical experience revealed a number of low-incidence failure modes that presented opportunities for improvement. Design changes have included, but are not limited to, a Y cable to permit battery changes without pump stoppage, increased pull strength of external cables from 35 to 200 lbs, an intermittent low-speed controller to improve aortic root washout, sintered titanium microsphere surface on the pump housing to prevent apical thrombus, and novel cone bearings to reduce thrombus formation. In summary, real world conditions challenge devices in ways that laboratory or animal experiments do not. Thorough case reviews have led to many improvements as the Jarvik 2000 continues through its second decade of implants.
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