The Pediatric-Scaled Continuous-Flow Total Artificial Heart: Where Are We Now?


In 2017, Kiyotaka Fukamachi, MD, PhD, Director of the Cardiovascular Dynamics Laboratory in the Department of Biomedical Engineering, and collaborators were the first to demonstrate successful implantation of a pediatric continuous-flow total artificial heart (P-CFTAH) in an acute preclinical study. They confirmed in vivo the P-CFTAH’s self-regulating performance, including pump speed, flow and current, and its ability to maintain standard hemodynamic measures and good left and right atrial balance in response to manipulations of systemic and pulmonary vascular resistance.

The team first presented their findings at the American Heart Association Scientific Sessions and published them the following year, in 2018, in the Journal of Heart and Lung Transplantation. This first study validated the dimensional scaling of the P-CFTAH device—which is a smaller version of Cleveland Clinic’s CFTAH for adults—in terms of size and performance.

The P-CFTAH device features a dual-pump design unified in a single, continuously rotating brushless DC motor and rotor assembly supported by a hydrodynamic bearing. The sensorless design can produce pulsatile flow with speed modulation and automatically balance left and right circulations without electronic intervention.

Nearly three years later, Dr. Fukamachi and his team are working to anticipate and address challenges common among these sorts of implantable devices.

“I am confident that our P-CFTAH will overcome size and durability challenges inherent in developing this type of device, but there are many other challenges to face, including the small market for pediatric devices,” said Dr. Fukamachi. “One solution for this is to use P-CFTAH in adult patients as a biventricular assist device, which would increase the market size.”

He went on to say, “We continue to test the P-CFTAH to address the challenge universal to all mechanical circulatory support devices of long-term biocompatibility. We are performing computational fluid dynamics analyses, in vitro testing on the bench and in vivo preclinical experiments. We are working as quickly as possible so that this device can help pediatric patients with heart failure soon.”

Adapted from Consult QD

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