Prolonged Extracorporeal Membrane Oxygenation Without Systemic Anticoagulation in Sheep.

Area of Science:

• Biomedical Engineering
• Cardiovascular Research
• Medical Device Innovation

Background:

• Clinically significant bleeding is a major complication of extracorporeal membrane oxygenation (ECMO), affecting over 40% of patients.
• Systemic anticoagulation, while necessary to prevent circuit thrombosis, increases bleeding risk.
• Existing ECMO systems face challenges in balancing anticoagulation needs with bleeding complications.

Purpose of the Study:

• To evaluate the InFlo MOBYBOX ECMO system's ability to mitigate thrombosis and hemolysis.
• To assess if the system's multimodal design can reduce reliance on systemic anticoagulation.
• To investigate performance under low-flow conditions, a high-risk scenario for coagulation.

Main Methods:

• A seven-day ovine study using InFlo MOBYBOX ECMO systems with a biopassive hydrophilic coating.
• Continuous low-flow conditions (1.8-2.2 L/min) were maintained without systemic anticoagulants.
• Evaluated oxygen delivery, carbon dioxide removal, clotting, hematology, and organ damage.

Main Results:

• The InFlo MOBYBOX showed minimal clot coverage (2.3% ± 3.1%) in the inlet helical pathway.
• No device degradation, systemic thrombosis, or end-organ damage was observed.
• Hematologic indices remained stable, hemolysis was absent (confirmed by plasma-free hemoglobin), and oxygen transfer was preserved.

Conclusions:

• The InFlo MOBYBOX shows potential for anticoagulant-free low-flow ECMO support.
• The multimodal approach, combining optimized fluidics and surface coating, may enhance safety.
• Further research could advance extracorporeal therapies by reducing thrombosis and hemolysis.