Methylprednisolone not beneficial to neonates undergoing heart surgery
MedWire News: Perioperative methylprednisolone is not beneficial in neonates undergoing heart surgery, study findings show.
A subgroup analysis of the trial of the perioperative corticosteroid revealed that it is also associated with an increased risk for infection in low-surgical-risk neonates, report Sara Pasquali (Duke Clinical Research Institute, Durham, North Carolina, USA) and co-authors in Pediatrics.
The authors conducted the current study after noting that previous research in the area has been limited by a lack of placebo control, reduced power, and grouping of various steroid regiments together in analysis.
For the present analysis, they linked clinical data from the Society of Thoracic Surgeons Database to medication data from the Pediatric Health Information Systems Database for 3180 neonates (=30 days of age) who underwent heart surgery between 2004 and 2008.
Overall, 686 (22%) neonates received methylprednisolone, which is prescribed to reduce the inflammatory response associated with cardiopulmonary bypass, on both the day of and day before surgery, 397 (12%) on the day before surgery only, 901 (28%) on the day of surgery only, and 1196 (38%) did not receive any type of corticosteroid on the day of or day before surgery.
Multivariate analysis revealed no significant differences in in-hospital mortality, postoperative length of stay, postoperative intensive care unit length of stay, or postoperative infection (sepsis, mediastinitis, wound infection, endocarditis) between the methylprednisolone-treated babies and the babies who received no steroids.
These results remained significant in sensitivity analysis stratified by surgical risk (low risk: Society of Thoracic Surgeons-European Association for Cardiothoracic Surgery [STS-EACTS] categories 1-3; high: STS-EACTS categories 4-5) and adjusted for surgery start time.
However, within the low-surgical-risk group, there was a significant association between methylprednisolone use and postoperative infection consistent across all methylprednisolone regimens, at an overall odds ratio of 2.6.
"Lower-risk operations are generally associated with shorter cardiopulmonary bypass times and reduced inflammatory response such that little benefit from the anti-inflammatory properties of corticosteroids may be expected, and the potential risks of therapy may have a relatively greater impact on outcome," the authors explain.
Pasquali and team note that they did not detect a significant benefit associated with any of the methylprednisolone regimens examined. They say that this may be due to the fact that corticosteroids may not completely address the multifaceted inflammatory response.
They conclude: "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 and furthermore supports the need for an adequately powered clinical trial in this population."
By Piriya Mahendra