Abstract 16713: Pre-Clinical 30-day Survival Results of the BiVACOR TAH

Abstract

Introduction: The BiVACOR Total Artificial Heart (TAH) replaces the failing heart with a durable and physiologically adaptive pump, which combines magnetic levitation and rotary blood pump technology. The pump has large clearances to minimize shear stress, generates pulse pressure via cyclic changes in pump speed, and modulates total outflow based on physiological conditions. A single rotor design enables a small pump size. Aim: Primary endpoint was survival at 30 days with normal end-organ function and absence of device related thromboembolism at necropsy. Methods: Five calves (82 - 108 kg) were implanted with the BiVACOR TAH and underwent continuous hemodynamic monitoring for 30 days. The pumps ability to generate a pulse pressure, balance outflow to the systemic and pulmonary circulations and to increase outflow in response to increased physical activity was assessed. Hemocompatibility and end-organ function were routinely monitored. Necropsy was performed on day 30 to evaluate for evidence of thromboembolism and end organ damage. Explanted pumps were examined. Results: All five calves survived to 30 days with normal end-organ function. Stable hemodynamics were achieved with normal pressures in the aorta and left and right atrium (MAP 111 ± 6 mmHg, CVP 12 ± 5 mmHg, LAP of 20 +/- 5 mmHg). Average estimated pump output was 12 ± 2 L/min with average pulse pressure of 30 mmHg. Pump output increased during changes in daily physiological condition (10 to 14 L/min). No device-related thromboembolism or other end organ pathologies were detected at necropsy. All explanted pumps were free of internal pump thrombus. Hemocompatibility was demonstrated (pfHb 4.34 ± 0.74 mg/dL). Bypass time decreased by 34 minutes over the entire study cohort. Conclusion: The BiVACOR TAH demonstrates normal hemodynamics including left/right balance. Pump design allows for a normal pulse pressure, increased pump output in response to exercise, and excellent hemocompatibility without device-related thromboembolism. Operative time markedly improves with surgeon experience. The small pump size may expand the use of TAH to smaller patients. This device may address the need for select patients with advanced heart failure who require biventricular support.