The biggest risks related to VAD surgery are bleeding, infection, and the failure of other organs, such as the kidneys, liver, or lungs. Since an LVAD supports only the left side of the heart, failure of the right side can occur and become a serious complication. The use of a mechanical circulatory device introduces inherent risks, however small, of events such as air entering the arteries during device implant or failure of the device itself.
Although risk is inevitable in the application of any medical technology, the Jarvik 2000 FlowMakerŽ has been developed and tested for over 20 years to minimize complications. Perhaps the Jarvik 2000's most important attributes in this regard are the simplicity and economy of its design.
With no inflow or outflow valves and no air vent tube to the outside of the body, the Jarvik 2000 eliminates the risk of problems associated with these components. The very small size of the Jarvik 2000 makes it the only blood pump to be implanted inside the natural heart's left ventricle. Its positioning inside the heart eliminates the risk of infection in a "tissue capsule" around the outside of the device because no such capsule forms. Capsule infection and air vent tube infection still occur at high rates in some VADs, while complications due to infections of all types remain much lower in Jarvik 2000, as reported in the scientific literature.
Stroke from blood clots has not yet been eliminated with the Jarvik 2000 and has occurred in 8-12% of all patients treated to date. Most have recovered significantly, and some have recovered completely. Better surgical technique and better anticoagulation management can further reduce the rate of blood clots associated with the Jarvik 2000. Additionally, a pump design improvement tested in animals but not yet introduced in patients appears promising. The risk of stroke with the Jarvik 2000 is about the same as the risk with the HeartMate and Novacor devices.
As a device that must operate safely inside the human body for long periods of time, the Jarvik 2000 has shown itself to be highly reliable, with no mechanical failures of the implanted blood pump in more than 200 cases to date. The titanium, blood-contacting surfaces are highly polished, biocompatible and remain corrosion free in the harsh environment that blood creates. The small, spinning impeller responsible for generating the bloodflow through the pump causes no clinically significant damage to blood cells.