Retrospective cohort analysis of a single dose of aprotinin use in children undergoing cardiac surgery: a single-center experience.

OBJECTIVES: The great difference in side effects of aprotinin was noted in adult and pediatric fields in recent reports because aprotinin was suspended for safety reasons. The aim of this study is to describe associations between aprotinin using and red blood cells transfusion, renal injury, and mortality in pediatric with cardiac surgery.

METHODS: We retrospectively reviewed a cohort of 507 consecutive children who received a single dose of aprotinin (March-November 2007 before the FDA's decision for withdrawal of aprotinin) and a cohort of 494 consecutive children who did not receive aprotinin or other antifibrinolytic drugs (December 2007-August 2008).

RESULTS: The two groups' demographics were assessed by the Aristotle basic complexity (ABC) propensity score. Postoperative blood loss was significantly reduced in the aprotinin group [P < 0.001, 95% confidence intervals (CI): 0.00-0.00], but postoperative red blood cell transfusion was not different between two groups (P = 0.4, 95% CI: 0.393-0.412). No statistical significant differences were noted in postoperative dialysis [0.39% vs. 0.40%, P = 0.98, OR: 0.974, 95% CI: 0.137-6.944] and intra-hospital mortality (2.37% vs. 1.82%, P: 0.547, OR:1.306, 95% CI: 0.546-3.129)) and reoperations for bleeding, thrombotic, and respiratory morbidity between two groups; however, the aprotinin group had temporarily a higher rate of 1.5-fold increased creatinine (class R) in the first postoperative 72 h (22.95% vs. 13.93%, P < 0.001, OR: 1.840, 95% CI: 1.323-2.560), a longer duration of mechanical intubation [6.50 (4.50-24.00) h vs. 6.00 (4.50-22.00) h, P = 0.004, 95% CI: 0.002-0.005] and a 0.55% increased clinical mortality (although not statistically significant). More complex surgery had a higher rate of the increased creatinine (class R) in the first postoperative 72 h (ABC level 3 + 4 vs. level 1 + 2, P = 0.017, OR: 0.599, 95% CI: 0.392-0.915). The multivariate analysis showed that age (<1 year), CPB >100 min, and the larger amount of transfusion (≥14 ml·kg(-1) ) were also important risk factors for the postoperative renal dysfunction (class R).

CONCLUSIONS: Except reducing postoperative bleeding, we did not find other benefits of aprotinin. However, much higher postoperative creatinine levels, longer duration of mechanical ventilation, not less postoperative RBCs transfusion, and a 0.55% increased clinical mortality (although not statistically significant) were found in the aprotinin populations.