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No Benefit of Corticosteroids in Neonatal Heart Surgery

NEW YORK (Reuters Health) Jan 25 - Methylprednisolone does not improve outcomes in newborns undergoing cardiac surgery, and it may increase the risk of infection in some of those infants, an observational analysis suggests.
"These data reinforce the need for a large randomized trial in this population," the authors conclude in their report, published online January 23 in Pediatrics.
Dr. Sara K. Pasquali, with Duke University Medical Center in Durham, North Carolina, and colleagues explain that corticosteroids are used in pediatric heart surgery to reduce the inflammatory response triggered by cardiopulmonary bypass. But while inflammatory markers are reduced, the clinical benefits are being increasingly questioned.
Using a congenital heart surgery database and another that provided data on medication usage, the researchers identified 3,180 newborns who had heart surgery over a five-year period. Twelve percent received methylprednisolone on the day before surgery, 28% received it on the day of surgery, 22% received it on both days, and 38% received no perioperative steroids at all.
Neither of the two primary outcomes -- in-hospital mortality and postoperative length of stay (LOS) - differed significantly between babies who did and did not receive steroids, according to the report.
Specifically, unadjusted in-hospital mortality was 10.5% with no steroids, compared to 13.7% with methylprednisolone on the day of surgery, 11.1% with methylprednisolone on the day before surgery, and 10.9% with treatment on both days (p=0.13)
Adjusted mortality odds ratios in the three groups given methylprednisolone were 1.28, 0.95, and 1.00, respectively.
LOS was 14 days in all groups except the one given methylprednisolone on the day of surgery, for which the LOS was 15 days, the report indicates.
Overall, the risk of postoperative infection was similar in all groups. However, when patients were classified as high or low surgical risk, there was a significantly increased likelihood of infection across all methylprednisolone regimens in the low-surgical-risk group, Dr. Pasquali and colleagues report.
"This multicenter observational analysis of methylprednisolone in neonates undergoing heart surgery, along with other recent studies, calls into question the benefits of corticosteroids in children undergoing heart surgery," they conclude, "and furthermore supports the need for an adequately powered clinical trial in this population."

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