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J Thorac Cardiovasc Surg 1998;115:220-224
© 1998 Mosby, Inc.

CARDIOPULMONARY SUPPORT AND PHYSIOLOGY

Operations on the thoracic aorta and hypothermic circulatory arrest: Is aprotinin safe?

From the Department of Cardio-Thoracic Surgery^a and Nephrology,^b University of Vienna, Vienna, Austria.

Received for publication April 22, 1997; revisions requested July14, 1997; revisions received Sept. 11, 1997; accepted for publication Sept.11, 1997. Address for reprints: Marek Ehrlich, MD, Department of Cardio-ThoracicSurgery, Mount Sinai Medical Center, One Gustave Levy Place, Box 1028, NewYork, NY 10029.

Abstract

Introduction: The safety of aprotinin,especially when used with profound hypothermic circulatory arrest, is stilla matter of intense debate despite its presumed salutary effects on bloodloss. Many investigators have reported toxic renal effects of high-dose aprotininin such patients, but no prospective, randomized study has been conducted.To assess the potential detrimental effect of aprotinin on renal functionand its putative reduction of blood loss, 50 patients undergoing thoracicaortic operations with the use of profound hypothermic circulatory arrestwere randomly assigned to receive either low-dose aprotinin (1 x10 ⁶ kallikrein activationunits) or placebo.
Methods: The specificrenal tubular markers ß-₂-microglobulin and ß-N-acetyl-d-glucosaminidase,as well as serum creatinine and blood urea nitrogen, creatinine clearance,sodium excretion, and potassium excretion, were measured to evaluate renalfunction preoperatively, immediately after the procedure, and 24 hours and48 hours later.
Results: No statisticallysignificant difference was found in any measured renal parameter between thetwo groups (analysis of variance). Renal dysfunction, defined as an elevationof serum creatinine early postoperatively (1.5 times the preoperativevalue), occurred in two patients who received aprotinin and in one patientin the control group. Temporary dialysis (hemodialysis or continuous venovenoushemofiltration) was needed in two patients in the aprotinin group versus onein the control group. Furthermore, patients treated with aprotinin had significantlyless total postoperative blood loss (718 ± 340 ml vs 920 ±387 ml, p = 0.04). The aprotinin recipientsalso had a significantly lower transfusion requirement (p <0.05).
Conclusion: Thiscontrolled trial of low-dose aprotinin in patients undergoing thoracic aorticoperations using profound hypothermic circulatory arrest demonstrated no detectabledeleterious effects on renal function; moreover, the use of aprotinin wasassociated with significantly lower need for transfusion. (J Thorac CardiovascSurg 1998;115:220–5)

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