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Safety of aprotinin use and re-use in pediatric cardiothoracic surgery
Robert D B Jaquiss1, Nancy S Ghanayem, Michael C Zacharisen
1Medical College of Wisconsin, and the Children's Hospital of Wisconsin, Milwaukee, Wisc, USA. rjaquiss@chw.org
Insights
Hypersensitivity reactions to aprotinin are rare in pediatric cardiothoracic surgery patients, even with repeated use. The study found low incidence and no severe outcomes, suggesting aprotinin is generally safe for pediatric cardiac procedures.
Area of Science:
- Pediatric Cardiac Surgery
- Anesthesiology
- Immunology
Background:
- Hypersensitivity reactions to aprotinin are documented in adult cardiac surgery.
- The incidence and impact of these reactions in pediatric patients are less understood.
Purpose of the Study:
- To determine the incidence and impact of hypersensitivity reactions to aprotinin in children undergoing cardiothoracic surgery.
- To evaluate the safety of aprotinin re-exposure in this population.
Main Methods:
- Retrospective review of 865 pediatric cardiothoracic surgery patients exposed to aprotinin.
- Classification of reactions as mild (Type A) or severe (Type B).
- Analysis of reaction incidence based on initial and subsequent exposures.
Main Results:
- Overall reaction incidence was low (1.0% on first exposure, 1.3% on second, 2.9% on third+).
- Reactions were not more likely with re-exposure compared to initial exposure.
- No adverse sequelae were attributed to aprotinin reactions; skin testing and IgE assays were not definitive predictors.
Conclusions:
- The risk of hypersensitivity reactions to aprotinin in pediatric cardiothoracic surgery is low.
- Aprotinin appears safe for pediatric use, even with multiple exposures.
- Current diagnostic methods like skin testing and IgE assays have limitations in identifying reactors.
Background:
Hypersensitivity reactions to aprotinin have been reported in adult cardiac surgical patients undergoing initial and re-exposure to the medication. This study describes the incidence and impact of aprotinin hypersensitivity reactions in children undergoing cardiothoracic surgery.
Methods And Results:
In this retrospective review of our entire experience with aprotinin (n=865), 681 first exposures, 150 second exposures, and 34 third or higher exposures were examined. Reactions were classified as mild (generalized cutaneous erythema, Type A) or severe (unexplained cardiopulmonary instability after aprotinin exposure, Type B). Records of patients sustaining a reaction were reviewed to assess the impact of the reaction on outcome and to survey reaction management strategies. Reactions occurred in 7 of 681 first exposures (1.0%), of which 2 were Type A and 5 were Type B. In second exposures, there were reactions in 2 of 150 (1.3%), of which both were Type B. In 34 third or higher exposures, there was only 1 reaction (2.9%), which was Type B. Reactions were no more likely on second, third, or higher exposure than on initial exposure. Skin testing had a negative predictive value of 98.9% and a positive predictive value of 20%. Anti-aprotinin IgE was undetectable in 7 of 8 reactor cases tested. No adverse sequelae were attributed to aprotinin reaction.
Conclusions:
The risk of hypersensitivity reactions to aprotinin is low in children undergoing cardiothoracic surgery, even with multiple exposures to the medication. Reactions are more likely with re-exposure, and risk increases with multiple exposures. Neither skin testing nor assays for IgE identified reactors.
