Recombinant activated factor VII in neonatal cardiac surgery

Area of Science:

• Cardiovascular Surgery
• Neonatal Medicine
• Hemostasis and Thrombosis

Background:

• Congenital heart defects necessitate complex surgical interventions in neonates.
• Cardiopulmonary bypass (CPB) is frequently employed during these procedures.
• Hemostatic management, including the use of recombinant activated factor VII (rVIIa), is critical.

Purpose of the Study:

• To investigate the association between rVIIa administration and intravascular thrombus formation in neonates undergoing cardiac surgery.
• To evaluate the impact of thrombus formation on patient outcomes, including mortality.

Main Methods:

• Retrospective analysis of neonates undergoing congenital cardiac lesion repair over a 9-year period.
• Comparison of thrombus formation rates in neonates who received rVIIa versus those who did not.
• Logistic regression analysis adjusted for relevant clinical scores and interventions.

Main Results:

• Overall thrombus frequency was 11% (45/416 operations).
• Thrombus formation occurred in 22% (28/129) of operations with rVIIa, compared to 6% (17/287) without rVIIa (OR 4.4, P < 0.0001).
• rVIIa administration remained significantly associated with thrombus formation after adjustment (OR 3.5, P = 0.0004).

Conclusions:

• rVIIa administration is associated with increased intravascular thrombus formation in neonates undergoing CPB surgery.
• Thrombus formation in the Norwood procedure population was linked to higher mortality.
• Careful consideration of rVIIa use in this vulnerable population is warranted.