CARD5: Chronic In-vivo evaluation of the BiVACOR rotary total artificial heart

Purpose: The BiVACOR Total Artificial Heart (TAH) combines magnetic levitation and rotary blood pump technology to create a small, durable and physiologically compatible device capable of replacing the failing heart. Pulsatile outflow is achieved via cyclic changes in pump speed, while large clearance gaps and flow paths improve hemocompatibility. The TAH is designed for implantation in women and some children, yet powerful enough to support adult males undergoing exercise. In preparation for first-in-human trials, in-vivo studies were undertaken using clinical-grade devices. Methods: The BiVACOR TAH was implanted into five calves (82 – 108 kg) for 30 days before elective termination. Hemodynamics, left-right balance, hemocompatibility, and end organ function were monitored throughout the study, while evidence of significant thromboembolism was evaluated at study termination via necropsy. Results: All five calves regained all physiological function (eating, drinking, defecating, standing, and regular treadmill exercise). The TAH demonstrated reliable operation, provided suitable hemodynamics (MAP 111 ± 6 mmHg, CVP 12 ± 5 mmHg, est.QL 12 ± 1 l/min) with pulsatile outflow (up to 40 mmHg @ 60BPM) and acceptable left/right balance (est.LAP-CVP 7.6 ± 3 mmHg). Normal end organ function was maintained (CREA 1 ± 0.44 mg/dL) with excellent hemocompatibility (pfHb 4.34 ± 0.74 mg/dL, LDH 1110 ± 182 U/L), while showing no evidence of significant device related thrombi or end organ dysfunction at necropsy. Summary: The BiVACOR TAH demonstrated promising chronic physiological performance, hemocompatibility, and physiological interaction. These results underpin progression of the BiVACOR TAH to first-in-human studies. The work was supported by NIH NHLBI under award number R44HL137454.