Realheart TAH in Brief
• Delivers physiological blood flow, pressure, and oxygenation
• Uses two atria and two ventricles to closely mimic natural blood flow
• Automatically adjusts blood flow volume based on atrial pressure
• Can pump different blood volume from the right and left ventricle to maintain right/left balance as in the natural heart.
A human heart consists of two pumps: a right pump and a left pump. The heart pumps blood through both pumps at the same time via a downwards movement of the plane between the atria and ventricles – the atrioventricular plane – delivering a pulsatile flow. Realheart TAH mimics this movement with its own atrioventricular plane, providing pulsatile blood flow that human organs are adapted to. Realheart TAH is designed to carefully mimic the natural blood flow to minimize blood damage and blood-related side effects that are common with existing heart pumps. To this end, the design undergoes thorough testing using multiple methods, including computer simulations, bench tests, and animal studies.
During treatment with implanted artificial hearts, infections can occur where the driveline passes through the skin. Realheart uses a thin driveline made of biocompatible material to minimize the risk of infection for the first product, but will evaluate the possibilities of cordless versions for future products.
Blood-related side effects are multifactorial problems. High shear stress and lack of pulse – both characteristics of existing continuous flow pumps – are noted as risk factors for many blood-related side effects. High shear stress can also damage blood cells themselves, leading to further complications. Realheart has carried out computer simulation studies in collaboration with University of Bath that concluded that Realheart TAH design results in low shear stress.
Compared to all other technologies on the market and those under development, we believe that Realheart TAH has the lowest risk of side effects thanks to the device’s natural blood flow pattern. No other technology known to Realheart can achieve pulsatile synchronized pumping on the right and left sides in combination with independently adjusted pumps for right/left balance, all controlled by the pressures in the atria – because no other heart pump has atria.
Although the product is designed and undergoing tests to minimize the risk of side effects, possible side effects can only be confirmed through clinical trials in patients.