Published in:
01-05-2008 | Journal Review
From Other Journals
Journal Review Editors: Ahmed Alomran, Sanjiv Gandhi, Omar M. Khalid
Published in: Pediatric Cardiology | Issue 3/2008
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This retrospective, nonrandomized cohort study compared two groups of pediatric cardiac surgical patients to determine whether aprotinin is associated with adverse outcomes, particularly mortality and acute kidney failure, following open heart surgery. The authors compared all children undergoing pediatric cardiopulmonary bypass operations from 1994–1999, when aprotinin was not used (n = 1230), with those who underwent surgery from 2000–2006, when all patients received high-dose aprotinin (n = 1251). Primary end points were operative and late mortality, acute kidney failure, need for dialysis, and neurologic complications. The aprotinin group was younger (mean age, 3.49 ± 1.84 vs. 3.64 ± 4.75 years; p = .019) and had a higher Aristotle score (7.8 ± 2.3 vs. 7.2 ± 2.6, p < .001). Univariate and multivariate analyses showed no significant difference between the two groups for operative mortality (55 [4.5%] vs. 47 [3.8%], p = .508), acute kidney failure (68 [6.0%] vs. 69 [5.7%], p = .77), need for temporary dialysis (6 [0.49%] vs. 12 [0.96%], p = .17), or neurologic complications (14 [1.1%] vs. 17 [1.4%], p = .62). Aprotinin also had no influence on late mortality (24 vs. 10 deaths, p = .078).-
Aprotinin is an antifibrinolytic serine protease inhibitor. It reduces bleeding by delaying the rapid plasmin-mediated lysis of the fibrin clot and also decreases the inflammatory response to cardiopulmonary bypass. Several recent adult studies have linked the use of aprotinin with perioperative acute kidney failure and cerebrovascular accidents in patients following heart surgery and have suggested a mortality risk associated with this drug. This information has led to a withdrawal of aprotinin from the market. This article establishes the safety of aprotinin for pediatric patients. The study does have limitations, in that the patients were not randomly assigned and were not contemporaneous. Changes in operative and postoperative protocols may have influenced outcomes irrespective of aprotinin administration, thus creating a time-based selection bias. However, despite the fact that the aprotinin group of patients was statistically younger and had a higher Aristotle score, use of the drug was not associated with an increase in the risk of biochemical acute kidney failure, need for dialysis, or neurologic complications and also was not associated with increased risk of operative or late mortality. This article supports the continued use of aprotinin in select patient populations, including complex pediatric patients undergoing cardiopulmonary bypass operations.