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Thrombotic risk of recombinant factor seven in pediatric cardiac surgery: a single institution experience
Todd J Karsies1, Kathleen K Nicol, Mark E Galantowicz
1Division of Critical Care, Nationwide Children's Hospital, Columbus, Ohio, USA.
Insights
Recombinant activated factor seven (rFVIIa) did not increase thrombosis in pediatric cardiac surgery patients. This hemostatic adjunct reduced bleeding and transfusion needs in congenital heart disease surgery.
Area of Science:
- Cardiovascular Surgery
- Hematology
- Pediatric Critical Care
Background:
- Recombinant activated factor seven (rFVIIa) is a hemostatic agent used in complex surgeries.
- Its safety and efficacy in pediatric congenital heart disease (CHD) surgery require thorough evaluation.
Purpose of the Study:
- To assess the thrombotic safety of rFVIIa in pediatric CHD surgery.
- To compare bleeding complications, transfusion requirements, and clinical outcomes between patients receiving rFVIIa and controls.
Main Methods:
- A retrospective matched case-control study was conducted over six years.
- Patients receiving rFVIIa post-CHD surgery were matched with controls based on age, diagnosis, and procedure.
- Outcomes analyzed included thrombosis, hemorrhage, transfusions, length of stay, and repeat procedures.
Main Results:
- No significant difference in thrombosis rates was observed between the rFVIIa group (8%) and controls (4%).
- rFVIIa use was associated with a significant reduction in transfusion volume (median 77.1 mL/kg vs 14.6 mL/kg) and decreased hemorrhagic chest tube output (8.3 vs 1.4 mL/kg/hour).
- No differences were found in ICU or hospital length of stay or mortality.
Conclusions:
- rFVIIa therapy did not elevate thrombotic complications in pediatric CHD surgery when used as rescue therapy.
- rFVIIa demonstrated a potential to decrease bleeding complications in this patient cohort.
Background:
Recombinant activated factor seven (rFVIIa) is increasingly being used as a hemostatic adjunct in pediatric cardiac surgery. We evaluated the thrombotic safety profile of rFVIIa in pediatric congenital heart disease (CHD) surgery.
Methods:
This was a retrospective matched case-control study over six years at a single institution. Patients who received rFVIIa after CHD surgery were matched to controls based on age, diagnosis, and procedure. We compared thrombosis, hemorrhage, transfusions, length of stay, and repeat procedures between groups.
Results:
Twenty-five patients received rFVIIa (mean dose: 70 mcg/kg); 50 controls were matched. There was no significant difference in the rate of thrombosis between patients who received rFVIIa and controls (8% vs 4%). After rFVIIa, there was a significant reduction in transfusion volume (median 77.1 mL/kg vs 14.6 mL/kg; p < 0.001) as well as a significant decrease in hemorrhagic chest tube output (8.3 +/- 1.6 mL/kg/hour vs 1.4 +/- 0.3 mL/kg/hour; mean +/- standard error of the mean; p < 0.001). No difference was seen in intensive care unit or hospital length of stay or mortality between patients receiving rFVIIa and controls.
Conclusions:
The rFVIIa therapy did not increase thrombotic complications when used as rescue therapy after CHD surgery but did appear to decrease bleeding complications in this small cohort.
