THE CLEVELAND CLINIC CONTINUOUS-FLOW TOTAL ARTIFICIAL HEART, SIMPLY SMART

Heart failure (HF) is a critical healthcare issue and a primary source of cardiovascular mortality worldwide. Globally, it is estimated that up to 100,000 people are candidates for heart transplantation, but only about 5800 transplants were performed in 2016. At Cleveland Clinic, we are developing a continuous-flow total artificial heart (CFTAH) in an attempt to provide a viable alternative to transplantation for the growing population of patients with end-stage HF. The Cleveland Clinic CFTAH is a double-ended centrifugal pump with only one moving part that is designed to passively self-balance left and right circulations without active intervention. The device has no mechanical bearings to wear out and is driven by an extremely reliable 3-phase brushless, sensorless motor. The nominal external dimensions of the latest version of our adult CFTAH design to be tested in-vivo were 98.4 mm in length, 62 mm in diameter, 160 cc in volume displacement and 486 g in weight without the cable. Biocompatibility of the CFTAH has been demonstrated in two full-term 90-day in vivo tests, completed without the use of any anticoagulation. Since the conclusion of these tests, our team has been working on design improvements to further reduce susceptibility to thrombosis, enhance autoregulation, improve motor controller hardware, add clinically useful features to the control interface and enhance manufacturability. Our results to date suggest that a small, mechanically and electronically simple, auto-regulated total artificial heart has significant potential to provide an important clinical option for HF patients.