Faculty Collaboration Database

Hypersensitivity reactions to aprotinin re-exposure in paediatric surgery. Eur J Cardiothorac Surg 2010 Feb;37(2):307-11

Date

09/22/2009

Pubmed ID

19767215

DOI

10.1016/j.ejcts.2009.07.049

Scopus ID

2-s2.0-74249101769 (requires institutional sign-in at Scopus site)   9 Citations

Abstract

OBJECTIVE: Hypersensitivity to aprotinin is low (1-3%) but more likely with re-exposure. The manufacturer issued a black box warning which lists aprotinin re-exposure within 1 year of prior exposure as a contraindication. We investigated the temporal relationship between re-exposure interval and hypersensitivity in children.

METHODS: With Human Research Review Board approval, charts of all patients exposed to aprotinin during cardiac surgery were reviewed. We extracted data for re-exposure interval and hypersensitivity to skin tests, intravenous test dosing or infusion of the loading dose. We defined systemic hypersensitivity as haemodynamic instability, respiratory symptoms or diffuse skin reaction temporally related to exposure.

RESULTS: From March 1994 to June 2007, there were a total of 2333 aprotinin exposures in 1824 patients. A total of 509 re-exposures occurred in 381 patients: 280 in 244 patients with early (within 1 year) re-exposure and 229 in 222 patients with late (after 1 year) re-exposure. Thirteen systemic hypersensitivity reactions occurred in the 509 re-exposures (2.6%): two during skin testing and 11 during the loading dose. Although the incidence of local hypersensitivity was increased with early re-exposure (6/280 or 2.1% vs 0/229, p=0.019), the incidence of the systemic reaction was not different between early and late re-exposures (6/280 or 2.1% (CI 0.8-4.6%) vs 7/229 or 3.1% (CI 1.2-6.2%), p=0.6). Six patients with a previous hypersensitivity reaction had an additional re-exposure to aprotinin; one of these patients had a systemic reaction during the third exposure.

CONCLUSION: The incidence and type of hypersensitivity to aprotinin re-exposure in our cohort is consistent with previous reports. Repeat exposure within 1 year did not increase the risk of systemic hypersensitivity.

Author List

Siehr S, Stuth E, Tweddell J, Hoffman G, Troshynski T, Jones D, Mitchell M, Ghanayem N

Authors

Stephanie S. Handler MD Associate Professor in the Pediatrics department at Medical College of Wisconsin
George M. Hoffman MD Chief, Professor in the Anesthesiology department at Medical College of Wisconsin
Michael Edward Mitchell MD Chief, Professor in the Surgery department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Adolescent
Adult
Aprotinin
Cardiac Surgical Procedures
Child
Child, Preschool
Drug Administration Schedule
Drug Eruptions
Drug Hypersensitivity
Epidemiologic Methods
Hemostatics
Humans
Infant
Infant, Newborn
Intraoperative Care
Serine Proteinase Inhibitors
Skin Tests
Time Factors
Young Adult