Abstract 8256: Timing of Perioperative Methylprednisolone and Outcome in Infants Undergoing Heart Surgery
Background: Prior studies suggested peri-operative corticosteroids may reduce the post-bypass inflammatory response after congenital heart surgery, particularly regimens involving 2 doses (most often 1 dose given the night before surgery, and 1 in the operating room). More recent studies have called this into question, including a trial of methylprednisolone (MP) showing no benefit of 2 doses vs. 1 in infants. Lack of a placebo group and power to assess mortality or risks of treatment (infection) have limited prior analyses. In the present study we evaluated outcomes across MP regimens vs. no steroids in a large cohort.
Methods: Clinical data from the Society of Thoracic Surgeons Database were linked to medication data from the Pediatric Health Information Systems Database for 25 participating centers. All infants (≤30d) undergoing heart surgery from 2004-2008 were included. Multivariable analysis adjusting for patient and center characteristics, surgical risk category, and within center clustering was used to evaluate the association of MP regimen with outcome.
Results: A total of 3180 infants were included: 22% received MP on both the day before and day of surgery, 12% on the day before surgery, 28% on the day of surgery, and 38% did not receive any peri-operative steroids. In multivariable analysis (Table), there was no significant mortality or length of stay benefit associated with any MP regimen (vs. no steroids), and no difference in infection (sepsis, mediastinitis, wound infection). In subgroup analysis by surgical risk group there was a significant association of MP with infection consistent across all regimens (overall OR 2.6, 95% CI 1.3-5.2) in the lower surgical risk group.
Conclusions: This multicenter observational analysis did not find any benefit associated with MP in infants undergoing heart surgery and suggested increased infection in certain subgroups. These data reinforce the need for a large randomized trial in this population.
- © 2011 by American Heart Association, Inc.