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J Thorac Cardiovasc Surg 1998;116:1082-1083
© 1998 Mosby, Inc.

LETTERS TO THE EDITOR

Fibrin sealant, aprotinin, and immune response in children undergoing operations for congenital heart disease

G. Schlag, J. Seifert

To the Editor:

In their well-planned study of 49 children, "Fibrin Sealant, Aprotinin, and Immune Response in Children Undergoing Operations for Congenital Heart Disease" (J Thorac Cardiovasc Surg 1998;115:883-9), Scheule and colleagues advise the reader that antibovine antibodies can be formed after professional application of a fibrin sealant. It is interesting to note that only some of the patients formed antibodies (14% immunoglobulin [Ig] E antibodies, 39% IgG antibodies); most patients did not form antibodies against aprotinin after identical application of the fibrin sealant.

Here it is important to ask the following question: Which factors led to the increased antibody formation? Even if data in Table IV do not show a significant difference with respect to the dose of aprotinin and the age of patients, the higher dose of aprotinin used in the older children seems to lead to an increased incidence of IgE or IgG antibodies. We must not forget that children of this age receive bovine milk products with their food. The gastrointestinal tract cannot be considered an absolute barrier for nutritious proteins, which can to some degree get into the blood without being degraded, and thus previous sensitization against bovine proteins cannot be excluded. A test for antibovine protein at baseline would have answered this question. We consider this a serious shortcoming of the study design that makes the conclusion doubtful.

Scheule and colleagues classified only the specific IgE antibodies according to their quantity, and only in 1 case could the level be classified as "high" (class III radio-allergosorbence test/fluorescence enzyme immunoassay). In this case the high value had already been determined 1 week after aprotinin application, which leads us to conclude that this patient had been sensitized against bovine protein before and that aprotinin in the fibrin sealant led to a booster effect.

The next important question is the clinical relevance of the antibodies found. Scheule and colleagues show that IgE antibody disappeared 1 year after exposure, suggesting a short half-life and therefore a low clinical relevance if any.

As far as we know from the manufacturer's pharmacovigilance department, there have only been 2 reports of anaphylactic reactions. In both cases the patients responded to standard treatment. The reports represent 2 cases in approximately 5 million applications, yielding a rate of 1 in 2.5 million. To minimize any risk, the medical histories taken before an operation should include questions on known allergies of any type and previous application of aprotinin, which may be used predominantly in heart surgery.


G. Schlag, MD
Professor of Anaesthesiology
Ludwig Boltzmann Institute for Experimental and Clinical Traumatology
Donaueschingenstrasse 13,
A-1200 Vienna, Austria

J. Seifert, MD
Professor
Chirurgische Forschung der Klinik Für Allgemeine
Chirurgie und Thoraxchirurgie
der Christian-Albrechts-Universität Kiel
Michaelisstrasse 5,
D-24105 Kiel, Germany

12/8/93095




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