Thrombotic Outcomes Associated With Factor Eight Inhibitor Bypassing Activity Use in Neonatal and Infant Cardiac Surgery Including the Norwood Procedure: A Propensity Score‒Matched Analysis

Nicholas Houska; Nicole McCaw; Emily C Meneses; Richard J Ing; Gina Whitney; Charles Fraser 3rd; Beth B Warren; Manchula Navaratnam; John S Kim

doi:10.1053/j.jvca.2026.05.071

Thrombotic Outcomes Associated With Factor Eight Inhibitor Bypassing Activity Use in Neonatal and Infant Cardiac Surgery Including the Norwood Procedure: A Propensity Score‒Matched Analysis

J Cardiothorac Vasc Anesth. 2026 May 30:S1053-0770(26)00472-6. doi: 10.1053/j.jvca.2026.05.071. Online ahead of print.

Authors

Nicholas Houska¹, Nicole McCaw², Emily C Meneses³, Richard J Ing⁴, Gina Whitney⁴, Charles Fraser 3rd⁵, Beth B Warren⁶, Manchula Navaratnam⁴, John S Kim⁷

Affiliations

¹ Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, CA. Electronic address: Nicholas.houska@childrenscolorado.org.
² School of Medicine, Stanford University School of Medicine, Stanford, CA.
³ Department of Pediatrics-Child Health Biostatistics Core, Stanford University School of Medicine, Stanford, CA.
⁴ Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, CA.
⁵ Division of Cardiothoracic Surgery, Stanford University School of Medicine, Stanford, CA.
⁶ Department of Pediatrics-Hemophilia and Thrombosis Center, Stanford University School of Medicine, Stanford, CA.
⁷ Department of Pediatrics-Division of Pediatric Cardiology; University of Colorado School of Medicine, Aurora, CO.

PMID: 42336705
DOI: 10.1053/j.jvca.2026.05.071

Abstract

Objectives: To describe thrombotic outcomes associated with Factor Eight Inhibitor Bypassing Activity (FEIBA) exposure in neonates and infants undergoing cardiac surgery with cardiopulmonary bypass (CPB), including the Norwood procedure.

Design: Single-center, retrospective, propensity score-matched cohort study.

Setting: Tertiary pediatric cardiac surgery center.

Participants: Neonates and infants (<1 year) undergoing cardiac surgery with CPB.

Interventions: FEIBA administered as rescue therapy for refractory bleeding following CPB.

Measurements and main results: The primary outcome was postoperative thrombosis at 7 and 30 days. After propensity score matching, 198 patients were analyzed across 4 cohorts (Norwood neonates, non-Norwood neonates, combined neonates, and infants). FEIBA exposure was not associated with a statistically significant increase in the odds of thrombosis at 7 or 30 days in any cohort. Among Norwood neonates, thrombosis rates were higher with FEIBA exposure (17.4% v 8.7% at 7 days; 26.1% v 13.0% at 30 days) but were not statistically significant (odds ratio [OR] 2.18, 95% confidence interval [CI] 0.37-17.28; p = 0.405 at 7 days and OR 2.22, 95% CI 0.48-12.13; p = 0.319 at 30 days). The odds of shunt intervention before stage II palliation were lower among FEIBA-exposed Norwood neonates (OR 0.20, 95% CI 0.04-0.88; p = 0.047).

Conclusion: This study found that FEIBA use was not associated with a statistically significant increase in postoperative thrombosis in neonates and infants after cardiac surgery. Though patients undergoing the Norwood procedure had a 2-fold (nonsignificant) increase in catheter-associated thrombosis, we found no increase in the rate of shunt thrombosis or intervention.

Keywords: FEIBA; Norwood procedure; hemostasis, cardiopulmonary bypass; neonate; prothrombin complex concentrate; thrombosis.