Abstract 1936: The Impact of Aprotinin on Outcomes in Infants Undergoing Cardiac Surgery in a Large Multi-institutional Database
Background: Aprotinin has been associated with renal failure and mortality in adults undergoing cardiac surgery and was withdrawn from the US market in 2007. The risks and benefits of aprotinin use in infant heart surgery continue to be debated.
Methods: We analyzed data on 5157 infants at 32 centers from the Pediatric Health Information System database who underwent stage I palliation, arterial switch operation or repairs of tetralogy of Fallot, truncus arteriosus, total anomalous venous return, common atrioventricular canal, or VSD from 2004 –2006 and in the 2nd half of 2008. Pts were classified into treatment groups:
either amicar or TXA, and
no antifibrinolytic therapy.
Results: Table 1⇓ summarizes pt demographics and postoperative outcomes in the antifibrinolytic exposure groups. In multivariate analysis, we adjusted for age and RACHS-1 category. Compared to that in the aprotinin group, adjusted in-hospital mortality was similar in the amicar/TXA group (OR 1.2, 95% CI 0.5–2.9) and the non-exposure group (0.9 (95% CI 0.7–1.2). Among all pts in RACHS-1 categories 4 and 6 in the 2nd half of 2006 vs. 2008, aprotinin was administered in 72% vs. 0%, TXA in 1% vs 21%, amicar in 2% vs. 34%, and no antifibrinolytic agent in 25% vs, 45%, respectively. Despite the unavailability of aprotinin in 2008, pts treated with antifibrinolytics in the two eras did not differ significantly in hospital LOS [median 20, range (13–20) vs. 23 (13–38), (p=0.12)], acute renal failure [9.3% vs 11.8%, (p=0.57)] or mortality [8.2% vs 8.7%, (p=1.0)].
Conclusion: In this multi-center, multivariable analysis of antifibrinolytics in infant heart surgery, aprotinin did not appear to confer a significant benefit on hospital mortality. TXA and amicar are currently being used in high-risk patients previously typically exposed to aprotinin without a significant era difference in postoperative outcomes.