Recombinant Factor VIIa in Pediatric Cardiac Surgery

Area of Science:

• Pediatric Cardiac Surgery
• Hemostasis and Thrombosis
• Pharmacology

Background:

• Recombinant activated factor VIIa (rVIIa) is used off-label for refractory bleeding post-pediatric cardiac surgery.
• Understanding its efficacy and safety profile in this population is crucial.

Purpose of the Study:

• To review the indications, usage rates, and complications of rVIIa in children undergoing cardiac surgery.
• To compare thrombotic events and re-exploration rates between rVIIa recipients and matched controls.

Main Methods:

• Retrospective case-control observational study at a single quaternary pediatric hospital.
• Reviewed 1,515 cardiopulmonary bypass procedures over three years.
• Matched 42 rVIIa recipients with two control patients each based on age, procedure type, and bypass time.

Main Results:

• rVIIa was administered in 2.8% of cases for refractory bleeding.
• Major systemic thrombotic complications occurred in 19% of rVIIa patients versus 12.5% in controls.
• 80% of rVIIa patients on ECMO experienced circuit thrombosis interventions, compared to 31.25% in controls.
• Re-exploration for bleeding was required in 4.76% of rVIIa recipients versus 1.39% of controls.

Conclusions:

• rVIIa use in pediatric cardiac surgery is linked to increased thrombotic complications, especially in children requiring ECMO.
• Further prospective studies are needed to understand coagulopathy and the role of hemostatic agents like rVIIa.