Safety and Efficacy of a Novel Pneumatic-Driven ECMO Device

Extracorporeal membrane oxygenation (ECMO) is rapidly becoming a mainstream technology for lung or heart/lung support. Current ECMO devices mostly consist of a power-driven centrifugal pump and a dedicated oxygenator. We studied the safety and efficacy of a novel, fully pneumatically-driven ECMO device, which could be used in both veno-venous or veno-arterial mode in an animal model.

Six healthy, awake sheep were treated with the Mobybox ECMO device (Hemovent, Aachen, Germany) over a 7-day period in a veno-venous mode. Gas exchange, coagulation parameters and safety were assessed.

Using a blood flow rate of 2 L/min and a low sweep gas flow rate of 0.3 L/min, the PCO ₂ ranged from 38-44 mmHg pre oxygenator and dropped to 32-36 mmHg post oxygenator, whereas the PaO ₂ post oxygenator increased to 600 mmHg. Higher levels of sweep gas flow resulted in cessation of spontaneous breathing in some animals, consistent with high-efficiency carbon dioxide removal; thus, the sweep gas flow rate was maintained at a low level. Platelets dropped from 177±53/μL to 107±28/μL on day two, while returning to baseline by day seven (180±51/μL). Plasma-free hemoglobin remained low (2-9 mg/dl), whereas fibrinogen slightly increased, and then remained stable throughout the period. Neither the pump nor the oxygenator showed any visible clotting after 7 days.

The pneumatically-driven ECMO device provides excellent safety and physiologic efficacy in a 7-day sheep experiment without visible clotting, hemolysis, or sustained reductions in fibrinogen or platelets.