Key result
Jarvik 2000 maintains ~7 L/min flow without thrombus during fatal systemic infection.
Why the study?
Clinical application of the Jarvik 2000 Heart had not yet begun and required initial clinical use data.
Case Report (n=1)
No
Initial clinical use of the Jarvik 2000 Heart demonstrated adequate flow and minimal thrombus formation despite severe systemic infection, though the patient ultimately died of sepsis.
May inform device choice in infected LVAD recipients; hypothesis-generating and requires prospective validation.
Clinical application of the Jarvik 2000® Heart has begun. The first patient was treated at the Texas Heart Institute in December under medical emergency conditions to replace an infected HeartMate with a torn inflow valve. The Jarvik 2000 flow at 10,000-14,000 RPM was 7.2± 1.9 L/min for 16 days but infection could not be controlled. The patient succumbed to sepsis, MOF & ARDS. Despite positive cultures for MRSA Staph, Serratia, VRE, and Candida, the pump remained extremely clean with only a tiny torus of thrombus < 1/2 mm thick at one bearing, and no evidence of thromboembolism. The clinical Jarvik 2000 utilizes redundant power cables, an all analog manually adjusted control system with alarm and power monitoring functions, and battery power at all times for electrical isolation from the mains. The belt worn Li-ion battery pack weighs ∼1 1/2 lbs. and powers the device for 10–12 hrs. A 15 lb. reserve lead/acid battery with up to 40 hrs of capacity is also provided. The configuration for bridge to recovery and permanent use includes a skull mounted percutaneous power transmission pedistal for an effective barrier to infection. The MDA has granted clinical study approval at the Oxford Heart Centre for patients with dilated cardiomyopathy as bridge to recovery. We expect to implant several patients before June, and also to begin an IDE bridge to transplant study at the Texas Heart Institute in the near future, pending FDA approval.
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Jarvik et al. (2000) conducted a case report in Infected HeartMate with a torn inflow valve (n=1). Jarvik 2000 Heart was evaluated. The Jarvik 2000 Heart provided 7.2±1.9 L/min flow for 16 days in a single emergency patient, remaining free of significant thrombus despite severe systemic infection that ultimately proved fatal.
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