BIO8: A 14-Day In-Vivo Evaluation of a Newly Developed Maglev ECMO System BreathMoAssistTM

Background: 60% ICU patients develop heart or respiratory failure with mortality of 23~75%. ECMO is the most effective method for providing cardiac and pulmonary support for those patients. The BreathMoAssistTM ECMO system is a newly developed ECMO system in China. The system has a maglev motor with a single use pump head, preventing the blood damage caused by mechanical contact bearings also providing up to 7L/min flow rate. It’s oxygenator provides a low pressure drop of less than 50mmHg at 7L/min flow rate. It also contains an ultra small portable console (weighing less than 10 kg), designed for flexible adjustment to patients needs. This study aims to evaluate the in-vivo performance and safety of the BreathMoAssistTM ECMO system. Methods: The study was conducted with 10 healthy sheep models, weighing 54.3~76.8 kg. 5 were performed using VA cannulation and 5 were performed using VV cannulation. The VA cannulation was accessed with a 14~16Fr arterial cannula surgically connected to the carotid artery and a 21~22Fr venous cannula inserted into the right atrium through the right jugular vein. The VV cannulation was performed with two 21~22Fr venous cannulas or a 26Fr double-lumen cannula surgically inserted through the jugular vein, and perfused blood to the right atrium. The pump flow rate was maintained at 1~3L/min. The sweep gas flow rate was maintained as 1:1 to the blood flow rate with 50~80% oxygen concentration. The blood and gas flow rates are adjusted according to venous and arterial oxygen saturation levels. Active clotting time was maintained within the range of 150~250s. Results: 8 sheep survived till the end of the study. One died on postoperative day (POD) 6 due to bleeding at the cannulation site. One sheep refused to eat and was not able to stand, the study was terminated at POD 12. Plasma-free hemoglobin results were within the acceptable range with the mean value of 3.14±2.475 mg/dL. The post-oxygenator blood saturation was maintained above 99%, and arterial PCO2 was maintained around 45mmHg throughout the study with all the animal models. All sheep’s biochemical test results were stable. The autopsy showed no embolism or thrombus formation and no end-organ damage. No device-related adverse event occurred. Conclusions: This study demonstrated that the BreathMoAssistTM ECMO system is able to provide pulmonary and cardiac support effectively and safely. These findings support magAssist continuing development and consideration for first-in-human studies.