Avecor Trillium oxygenator versus noncoated Monolyth oxygenator: a prospective randomized controlled study

Area of Science:

• Biomedical Engineering
• Cardiovascular Surgery
• Materials Science

Background:

• Cardiopulmonary bypass (CPB) is associated with adverse effects.
• Surface coatings aim to mitigate CPB-induced harm.
• Investigating biomaterials like heparin, PEO, and sulfate/sulfonate groups for oxygenator coatings.

Purpose of the Study:

• To evaluate the impact of a coated hollow fiber membrane oxygenator on coagulation, inflammation, and clinical outcomes.
• To compare a biopassive surface oxygenator (Avecor) with a standard uncoated oxygenator (Monolyth).

Main Methods:

• Randomized trial of 200 patients undergoing valve surgery with or without coronary artery bypass grafting.
• Patients received CPB using either the coated Avecor or uncoated Monolyth oxygenator.
• Primary and secondary endpoints included biochemical markers, coagulation profiles, inflammatory mediators, blood loss, and neurological events.

Main Results:

• No significant differences were observed in biochemistry, coagulation profiles, inflammatory mediator release, or blood loss between the coated and uncoated oxygenator groups.
• Five patients in the coated oxygenator group experienced strokes, confirmed by CT scan, while no strokes occurred in the uncoated group.

Conclusions:

• The Avecor coated oxygenator demonstrates comparable performance to standard uncoated oxygenators regarding inflammation and coagulation.
• An elevated rate of neurological events was observed in patients using the Avecor oxygenator, warranting further investigation.
• Additional research is necessary to elucidate the reasons behind the increased neurological events.