In vivo Hemodynamic Evaluation of an Implantable Left Ventricular Assist Device in a Long-term Anti-coagulation Regimen

Left ventricular assist devices (LVADs) are used to treat patients with severe (New York Heart Association class IV) heart failure. Thrombosis and bleeding are severe LVAD-related complications; thus, an effective anticoagulation regimen is crucial for successful postoperative management. The CH-VAD™ (CH Biomedical, Inc.) is a small, implantable, full-support (>5 L/min) LVAD with a centrifugal flow pump that has a fully magnetically levitated rotor, which confers superior hemocompatibility. In this study, the CH-VAD™ was implanted in two calves to evaluate its hemocompatibility and to establish an anticoagulation regimen for future GLP (good laboratory practice) studies. Heparin infusion was used during the surgery, and during postoperative management, the proper dosage of warfarin was given orally to maintain an international normalized ratio (INR) between 2.0 and 3.0. Pump performance, animal condition, and hematology results were recorded throughout the study (approximately 60 days). The results show that under the established anticoagulation regimen, the CH-VAD™ was well tolerated in the bovine model, with no significant thrombus or thromboembolic lesion formation in distal end organs. Low plasma free hemoglobin levels suggest that the device did not cause hemolysis. These results and the experience gained pave the way for future GLP studies.