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Aprotinin in pediatric cardiac operations: a benefit in complex malformations and with high-dose regimen only
T P Carrel1, M Schwanda, P R Vogt
1Clinic for Cardiovascular Surgery, University Hospital, Zürich, Switzerland. thierry.carrel@insel.ch
Insights
High-dose aprotinin (a drug) effectively reduced blood loss and transfusion needs in complex pediatric heart surgeries, specifically transposition of the great arteries. However, it was not beneficial for routine congenital heart operations.
Area of Science:
- Cardiovascular Surgery
- Pediatric Cardiac Surgery
- Anesthesiology
Background:
- Limited data exists on aprotinin's benefits and indications in congenital heart operations.
- Previous studies involved small patient numbers across heterogeneous malformation groups.
Purpose of the Study:
- To investigate the efficacy and safety of aprotinin in pediatric patients undergoing congenital cardiac surgery.
- To compare low-dose and high-dose aprotinin regimens against a control group.
Main Methods:
- Aprotinin's efficacy was studied in 3 groups of children (<15 kg): ventricular septum defect, tetralogy of Fallot, and transposition of the great arteries.
- Two aprotinin regimens (low-dose A1, high-dose A2) were compared to a control (A0) for perioperative blood loss, transfusion needs, and coagulation effects.
Main Results:
- Aprotinin did not significantly alter coagulation tests or platelet counts compared to controls.
- High-dose aprotinin significantly reduced blood loss and transfusion requirements in transposition of the great arteries.
- No significant differences in blood loss or transfusion needs were observed for ventricular septum defect or tetralogy of Fallot patients.
Conclusions:
- High-dose aprotinin is effective in reducing blood loss and transfusion requirements solely in complex congenital cardiac operations.
- Aprotinin is not recommended as a routine blood conservation agent in pediatric cardiac surgery.
Background:
The benefits and the current indications of aprotinin in congenital operations are not well defined. At present there are only a few studies available that have investigated a small number of patients in several heterogeneous groups of malformations.
Methods:
We investigated efficacy and safety of aprotinin in three groups of children < 15 kg, presenting with isolated ventricular septum defect (n = 60), tetralogy of Fallot (n = 52), and transposition of the great arteries (n = 56). Low-dose aprotinin regimen A1 (500,000 KIU in pump prime only) and high-dose aprotinin A2 (50,000 KIU/kg during induction of anesthesia, 50,000 KIU/kg in pump prime, and 20,000 KIU/h continuous infusion) were compared to a control group A0 (without aprotinin) regarding perioperative blood loss, transfusion requirements, and effects on the coagulation system.
Results:
The most common coagulation tests of aprotinin-treated patients and the platelet numbers were comparable with those of control patients preoperatively and 15 minutes after protamine administration. A significant dose-dependent reduction in fibrin-fibrinogen split products was observed at the end of cardiopulmonary bypass in the majority of aprotinin-treated patients with transposition. In patients with ventricular septum defect and Fallot, no significant difference in blood loss and transfusion requirements could be observed between patients with or without aprotinin and no difference was observed between low- and high-dose regimen. In transposition of the great arteries, high-dose aprotinin led to significant reduction of blood loss (p = 0.02) and postoperative blood transfusion (p = 0.003). Severe side effects as a result of administration of aprotinin were not observed.
Conclusions:
High-dose aprotinin reduces blood loss and transfusion requirement only in complex congenital cardiac operations; therefore aprotinin cannot be recommended as a blood conservation agent in routine pediatric operations.