No abstract

Two equally important issues need to be addressed during the early stages of the design of an implantable total artificial heart (TAH): proper anatomical fit and cardiac output capacity. As part of a first-time feasibility study to develop a neonate-size TAH, two studies were conducted to establish useful anatomical and physiological standards. The first (Study A) was conducted to determine the maximum dimensions of a neonate-size TAH. Twelve preserved hearts from full-term neonates with the hypoplastic left heart syndrome were examined. A second study (Study B) was designed to determine the acceptable minimum stroke volume compatible with minimum neonate cardiac output requirements. This study was based on a combination of: a) reported cardiac output studies in healthy term neonates, and term neonates with heart failure, b) body weight range, and c) limiting factors of TAH technology, e.g., valvular regurgitation and leveling off of the maximum cardiac output value at a specific heart rate and filling pressure. The proposed neonatal standards for TAH technology are presented.

A bolus method for noninvasive measurement of cardiac output (CO) and mixed venous oxygen content (O2) has been tested against absolute CO and O2 standards in dogs. No statistical differences in CO were found between bolus method and electromagnetic flowmeter measurement comparisons in an 18-dog study in which CO varied from 0. 5 to 3.0 l/min. The SD for all paired differences was 0.14 l/min; however, data averaging over 10-min intervals were found to reduce the CO measurement uncertainty to <0.08 l/min. The ability of the bolus method to follow rapid CO changes, experimentally produced by control of a pump (surgically placed between the superior and inferior vena cava and the right atrium), was documented and found to satisfy CO monitoring requirements of unstable subjects. O2 bolus values were found to be statistically equivalent to reference measurements.

No abstract