Thrombotic Outcomes Associated With Factor Eight Inhibitor Bypassing Activity Use in Neonatal and Infant Cardiac...

Area of Science:

• Pediatric Cardiology
• Hematology
• Cardiovascular Surgery

Background:

• Cardiopulmonary bypass (CPB) in neonates and infants undergoing cardiac surgery carries risks of bleeding and thrombosis.
• Factor Eight Inhibitor Bypassing Activity (FEIBA) is used for refractory bleeding but its thrombotic risk in this population is unclear.

Purpose of the Study:

• To evaluate thrombotic outcomes in neonates and infants exposed to FEIBA after cardiac surgery with CPB.
• To specifically assess risks associated with the Norwood procedure.

Main Methods:

• Retrospective, propensity score-matched cohort study at a single tertiary pediatric cardiac surgery center.
• Analysis of 198 neonates and infants (<1 year) undergoing cardiac surgery with CPB.
• FEIBA administered as rescue therapy for bleeding post-CPB.

Main Results:

• FEIBA exposure was not linked to a statistically significant increase in postoperative thrombosis at 7 or 30 days across all cohorts.
• Norwood neonates receiving FEIBA showed a nonsignificant 2-fold increase in thrombosis (17.4% vs 8.7% at 7 days).
• FEIBA-exposed Norwood neonates had significantly lower odds of shunt intervention before stage II palliation (OR 0.20, p=0.047).

Conclusions:

• FEIBA use is not associated with a significant increase in postoperative thrombosis in pediatric cardiac surgery patients.
• While a trend towards increased catheter-associated thrombosis was observed in Norwood neonates, shunt thrombosis and intervention rates were not elevated.