LAUSR

BACKGROUND Heart failure is a growing health problem worldwide. Due to the lack of donor hearts there is a need for alternative therapies, such as total artificial hearts (TAHs). The aim of this study is to evaluate the hemodynamic performance of the Realheart® TAH, a new 4-chamber cardiac prosthesis device. METHODS The Realheart® TAH was connected to a hybrid cardiovascular simulator with inflow connections at left/right atrium, and outflow connections at the ascending aorta/pulmonary artery. The Realheart® TAH was tested at different pumping rates and stroke volumes. Different systemic resistances (20.0-16.7-13.3-10.0 Wood units), pulmonary resistances (6.7-3.3-1.7 Wood units), and pulmonary/systemic arterial compliances (1.4-0.6 mL/mmHg) were simulated. Tests were also conducted in static conditions, by imposing predefined values of preload-afterload across the artificial ventricle. RESULTS The Realheart® TAH allows the operator to finely tune the delivered flow by regulating the pumping rate and stroke volume of the artificial ventricles. For a systemic resistance of 16.7 Wood units the TAH flow ranges from 2.7±0.1 to 6.9±0.1 L/min. For a pulmonary resistance of 3.3 Wood units the TAH flow ranges from 3.1±0.0 to 8.2±0.3 L/min. The Realheart® TAH delivered a pulse pressure ranging between ~25 mmHg and ~50 mmHg for the tested conditions. CONCLUSIONS The Realheart® TAH offers great flexibility to adjust the output flow and delivers good pressure pulsatility in the vessels. A low sensitivity of device flow to the pressure drop across it was identified and a new version is under development to counteract this.