Expanding the Performance Envelope of the Total Artificial Heart: Physiological Characterization, Development of a Heart Failure Model, And Evaluation Tool for Mechanical Circulatory Support Devices

Abstract

Heart failure (HF) affects an estimated 5.8 million Americans, accounting for near 250,000 deaths each year. With shortages in available donor hearts, mechanical circulatory support (MCS) has emerged as a life-saving treatment for advanced stage HF. With growth in MCS use, a clinical and developmental need has emerged for a standard characterization and evaluation platform that may be utilized for inter-device comparison and system training. The goal of this research was to harness SynCardia's total artificial heart (TAH) to meet this need. We first sought to characterize the TAH in modern physiological terms - i.e. hemodynamics and pressure-volume loops. We then developed a model of HF using the TAH and mock circulatory system operating in a reduced output mode. We demonstrated that MCS devices could be incorporated and evaluated within the HF model. Finally, we characterized the operational envelope of SynCardia's Freedom (portable), Driver operating against varying loading conditions. Our results describe the hemodynamic envelope of the TAH. Uniquely, the TAH was found not to operate with time-varying elastance, to be insensitive to variations in afterload up to at least 135 mmHg mean aortic pressure, and exhibit Starling-like behavior. After transitioning the setup to mimic heart failure conditions, left atrial pressure and left ventricular pressure were noted to be elevated, aortic flow was reduced, sensitivity to afterload was increased, and Starling-like behavior was blunted, consistent with human heart failure. The system was then configured to allow ready addition of ventricular assist devices, which upon placement in the flow circuit resulted in restoration of hemodynamics to normal. Lastly, we demonstrated that the Freedom Driver is capable of overcoming systolic pressures of 200 mmHg as an upper driving limit. Understanding the physiology and hemodynamics of MCS devices is vital for proper use, future device development, and operator training. Characterization of the TAH affords insight into the functional parameters that govern artificial heart behavior providing perspective on differences compared to the human heart. The use of the system as a heart failure model has the potential to serve as a valuable research and teaching tool to foster safe MCS device use.