Key result
The totally implantable Novacor left ventricular assist system demonstrated normal hemodynamics and operation in a chronic ovine model, with a total system implant functioning for 260 days.
Preclinical ovine evaluation of the totally implantable Novacor LVAS demonstrated normal hemodynamics and system efficacy over a 260-day implant period, supporting its potential for long-term mechanical circulatory support.
Animal model durability supports LVAS feasibility; leaves open human translation and long-term safety confirmation.
The totally implantable Novacor left ventricular assist system (LVAS) comprises a pump/drive unit (VAD), electronic control and power subsystem (ECP), variable volume compensator (VVC), and belt skin transformer (BST). The system is now undergoing chronic in vivo evaluation. Cumulative animal testing of VAD, VVC, and BST subsystems are 12.1, 4.9, and 43 years, respectively. The longest implants were 279 days for the VAD, 767 days for the VVC, and 1,148 days for the BST. A chronic implant of the total system was electively terminated at 260 days. The LVAS was powered via the BST. Continuously monitored hemodynamic and pump parameters have demonstrated normal hemodynamics and LVAS operation. Periodic VVC determinations suggest a 0.8 ml/day diffusive gas loss. Tether-free operation has been demonstrated with an Ag-Zn battery backpack. The animal was healthy and free of infection as indicated by routine hematologic, biochemical and serum enzyme determinations. Hemolysis is minimal (plasma free hemoglobin less than 5 mg%). Pump output ranged from 7 to 8 L/min. Severe valve calcification was the reason for elective termination at 260 days. This preclinical in vivo experience, and in vitro reliability studies, demonstrate efficacy of the total system.
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CHEN et al. (1989) studied this question. Novacor left ventricular assist system (LVAS) was evaluated on Hemodynamic and pump parameters, system efficacy and reliability. The totally implantable Novacor left ventricular assist system demonstrated normal hemodynamics and operation in a chronic ovine model, with a total system implant functioning for 260 days.
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