40: Preliminary Data on the Safety and Performance of a Novel Extracorporeal Membrane Oxygenation Device in a Long-term Ovine Model

A novel portable extracorporeal membrane oxygenation (ECMO) device (Lifemotion®) has been developed. The aim of this study is to assess the safety and performance of this ECMO device with small tailed Han sheep. Sheep were supported using Lifemotion® (Chinabridge, China)(Figure 1) and Novalung Xlung kit 230 (as Control) with VV-ECMO)and VA-ECMO modes. Tracheal intubation, arteriovenous access and ECMO support were performed. Vital signs and blood laboratory tests of the subjects were monitored and recorded. Main organs were examined pathologically at the end of day fourteen. Fifteen sheep were survived until day fourteen, with ten in the Lifemotion® group (five VV-ECMO and five VA-ECMO) and five in the Control group (two VV-ECMO and three VA-ECMO). All sheep were successfully weaned from ECMO without transfusion or cannula complications. No significant differences were observed between the two groups in terms of vital signs, oxygenation, hemodynamic stability, and physiological function(Figure 2, Figure3). No obvious thrombosis and bleeding was observed at main organs, such as the brain, liver, and lung, etc. There were no serious adverse events and no disposable items replaced due to thrombosis during the monitor period. Both groups had satisfactory values in vital signs, blood gas, most blood cell count values, blood biochemistry during VV-ECMO and VA-ECMO. In this animal trial the novel ECMO device, Lifemotion®, demonstrated the safety and acceptable performance of the device by providing satisfactory oxygenation, stable hemodynamics and physiological function to the sheep. This study provides preliminary evidence for future clinical trials.