Preclinical Testing of a Novel Extracorporeal Membrane Oxygenation System in an Acute Cardiogenic Shock Animal Model

ABSTRACT Background Preclinical studies with appropriate large animal experimental models are critical to the development of extracorporeal membrane oxygenation (ECMO) technology. This study aimed to evaluate the safety and efficacy of a novel ECMO system, compared with a commercially available ECMO system, in a large animal model of acute cardiogenic shock (ACS). Methods Eight healthy pigs (3 months old) were randomly assigned to four experimental groups to compare a novel ECMO device (the Hui Sheng‐1), coupled with a modified centrifugal pump (CP‐1) ( n = 2) or a Maquet RF32 centrifugal pump ( n = 2) with a commercial ECMO device, coupled with either a CP‐1 ( n = 2) pump or a RF32 pump ( n = 2) Following general anesthesia, a median sternotomy and central cannulation (aorta‐right atrium) was performed, ACS was induced, and a veno‐arterial ECMO model was established and operated continuously for 48 h. During the experiment, the rotation, flow rate, and mean arterial pressure were recorded, and complete blood cell counts, blood‐gas analysis, coagulation function, free hemoglobin concentration, and inflammatory factor concentrations were monitored. Results ACS was induced and ECMO was successfully performed in all animals without serious bleeding, thrombosis, instrument failure, or other adverse events. There was no statistically significant difference in free hemoglobin concentration between the experimental groups at every recorded time point ( p > 0.05). The ECMO rotation and flow rate were stable in all groups, and there was no significant difference in the mean arterial pressure or lactate level between the groups ( p > 0.05). IL‐1β, IL‐6, and IL‐10 levels were significantly lower in the CP‐1 groups than in the RF32 centrifugal pump groups ( p < 0.05), while there was no significant difference in TNF‐α, and IL‐8 levels ( p > 0.05). Conclusions Our data suggest that the novel ECMO device is safe and efficient during short‐term use in a large animal model of ACS.