Factor Eight Inhibitor Bypass Activity Use in Cardiac Surgery: A Propensity-matched Analysis of Safety Outcomes

Area of Science:

• Cardiology
• Hematology
• Critical Care Medicine

Background:

• Refractory bleeding during cardiac surgery poses a significant clinical challenge.
• Off-label use of Factor Eight Inhibitor Bypass Activity (FEIBA) is explored for managing such bleeding.
• Existing safety data, especially regarding thromboembolic events, is limited and shows mixed results.

Purpose of the Study:

• To evaluate the safety and outcomes of using FEIBA in adult patients undergoing cardiac surgery.
• To assess the association between FEIBA administration and thromboembolic complications, renal failure, and mortality.
• To compare outcomes between patients receiving FEIBA and a propensity-matched control group.

Main Methods:

• A retrospective review of adult cardiac surgery patients on cardiopulmonary bypass from July 2018 to June 2023.
• Propensity score matching (1:1 ratio) was used to create comparable groups of patients who received FEIBA and those who did not (n=352 per group).
• Primary outcome: composite of postoperative thromboembolic complications; Secondary outcomes: renal failure, reoperation, transfusion needs, ICU stay, and 30-day mortality.

Main Results:

• No significant difference in thromboembolic outcomes, ICU length of stay, or mortality between FEIBA and control groups.
• Patients receiving >750 U of FEIBA had significantly higher odds of acute renal failure (OR, 4.14).
• FEIBA recipients required more plasma and cryoprecipitate; doses of 501-750 U correlated with increased erythrocyte and platelet transfusions.

Conclusions:

• Low-dose FEIBA administration in cardiac surgery is not associated with increased thromboembolic events, ICU stay, or mortality.
• Higher FEIBA doses (>750 U) are linked to increased acute renal failure.
• Further research is needed to confirm the efficacy of activated factor concentrates for refractory bleeding in cardiac surgery.