Artificial organs · 2025
Evaluation of Gas Exchange and Hemocompatibility of an Experimental Oxygenator at Anticipated Human Fetal Flow Rates in Fetal Lambs Using a Dual Oxygenator Platform in the EXTra-Uterine Environment for Neonatal Development (EXTEND) System.
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Kosaka Seitaro, Wangmo Urgyen, Butt Zoya, Dave Apeksha, Hayes Kevin B, Choudhry Alia Mohsin, Khan Sameer A, Ngo Michelle, Weisman Hannah R, White Rachel S, Varela Maria F, Herrera Cruz Daisy C, Crompton Dan, Davey Marcus G, Flake Alan W
Аннотация
BACKGROUND: We previously reported the EXTEND (EXTra-uterine Environment for Neonatal Development) system provides physiologic support of fetal lambs (105-111 days gestational age; GA) via a pumpless arteriovenous circuit using a commercially available oxygenator (Maquet-Ox). However, for anticipated human subjects at 23-28 weeks of GA, a smaller oxygenator is required. To meet this requirement, a proprietary oxygenator (Experimental Oxygenator: Exp-Ox) was developed.
METHODS: Fourteen lambs (mean GA 99 days, mean weight at cannulation 1.36 kg) were placed on the EXTEND system. Thereafter, Exp-Ox was connected in parallel with the Maquet-Ox, and its durability and hemocompatibility were assessed over a prolonged use of up to 21 days, utilizing a dual oxygenator platform. Blood flow to Exp-Ox was increased over time using a tubing clamp to maintain the anticipated human fetal flow rates (50-165 mL/min).
RESULTS: Throughout the study, there was no deterioration in the oxygen and CO2 exchange function. The pressure drop in the Exp-Ox remained unchanged over time, with no statistically significant difference, whereas the calculated Exp-Ox resistance (pressure drop/blood flow) decreased since the change in pressure drop increased at a slower rate than the increase in blood flow. The quantitative clot burden in the Exp-Ox following completion of the study ranged from 0.03% to 2.55%, with no correlation to study duration.
CONCLUSIONS: The study demonstrated the Exp-Ox maintained its ability to transfer oxygen and CO2 and sustained hemocompatibility for up to 21 days at anticipated fetal flow rates on the EXTEND system.
METHODS: Fourteen lambs (mean GA 99 days, mean weight at cannulation 1.36 kg) were placed on the EXTEND system. Thereafter, Exp-Ox was connected in parallel with the Maquet-Ox, and its durability and hemocompatibility were assessed over a prolonged use of up to 21 days, utilizing a dual oxygenator platform. Blood flow to Exp-Ox was increased over time using a tubing clamp to maintain the anticipated human fetal flow rates (50-165 mL/min).
RESULTS: Throughout the study, there was no deterioration in the oxygen and CO2 exchange function. The pressure drop in the Exp-Ox remained unchanged over time, with no statistically significant difference, whereas the calculated Exp-Ox resistance (pressure drop/blood flow) decreased since the change in pressure drop increased at a slower rate than the increase in blood flow. The quantitative clot burden in the Exp-Ox following completion of the study ranged from 0.03% to 2.55%, with no correlation to study duration.
CONCLUSIONS: The study demonstrated the Exp-Ox maintained its ability to transfer oxygen and CO2 and sustained hemocompatibility for up to 21 days at anticipated fetal flow rates on the EXTEND system.