Anatomical Human Fitting of the Bivacor Total Artificial Heart

Purpose BiVACOR is a novel total artificial heart utilising a single centrifugal magnetically levitated rotor with the ability to modulate pulsatile flow through speed variation. The device has been successfully tested in cattle with encouraging 90-day results. We sought to undertake a multicentre virtual and anatomical fitting study of the BiVACOR in patients undergoing heart transplantation. Methods 10 patients on the heart transplant waiting list were recruited (5 Females, 5 Males) across two heart transplant centres. A 1:1 titanium model of the device with correct port configuration (Aorta, Pulmonary Artery, Right Atrium, Left Atrium) was provided by BiVACOR. Chest size and major vessel measurements were recorded from preoperative CT Scans. The sterilised model was then inserted into the patient's chest cavity post heart explant, prior to implantation of the donor heart. The atrial ports (right and left) on the device were lined up with their native counterparts. Measurements were recorded in-situ. The Device was then removed. 3D reconstructions were also created to simulate a virtual fitting. Results Mean age was 53 years (Range 38-67). Mean BMI was 28 (Range 20-37). Aetiology was varied - 5 Patients had Ischaemic Cardiomyopathy, whereas 1 was restrictive, 1 was giant cell myocarditis and 3 were dilated cardiomyopathy. Four had re-do sternotomies and 3 of these involved a ventricular assist device explant. Mean Spine-to-Sternum distance at the level of T10 was 14cm (range 11-18). Mean Ao diameter was 3.1cm (range 2.5-3.8). Mean PA Diameter was 3.4cm (range 2.0-4.2). Mean Ao to Ao Port distance was 0.2cm (range 0-0.5). Mean PA to PA Port distance was 4.2cm (range 1-7). The device fit in all patients. There was no gross distortion to the geometry between native vessels/chambers and ports. Conclusion This study described the virtual and anatomical fitting of the BiVACOR total artificial heart. The device fit within the chest cavities of all 10 patients, who represented a variety of body morphologies and heart failure aetiology.