NEW YORK (Reuters Health) – Methylprednisolone does not improve outcomes in newborns undergoing cardiac surgery, and it may increase the risk of infection in some of those infants, according to the results of an observational analysis reported in the February issue of Pediatrics.
“These data reinforce the need for a large randomized trial in this population,” the authors conclude.
Dr. Sara K. Pasquali, with Duke University Medical Center in Durham, North Carolina, and colleagues explain that corticosteroid administration in children undergoing heart surgery is intended to reduce the inflammatory response triggered by cardiopulmonary bypass. While inflammatory markers are reduced, the clinical benefits are being increasingly questioned.
To investigate, the team linked information from a congenital heart surgery database and another that provided data on medication usage. This identified 3180 neonates that underwent heart surgery over a 5-year period; 38% received no perioperative steroids while 28% received methylprednisolone on the day of surgery, 12% on the day before surgery, and 22% on both days.
Primary outcomes were in-hospital mortality and postoperative length of stay. Neither was significantly different between the group that did not receive steroids and the groups that did.
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.
Total length of stay 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 postop 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,”:
SOURCE:
Perioperative Methylprednisolone and Outcome in Neonates Undergoing Heart Surgery
Pediatrics 2012;129:385–391.
