Medrol, Similar Glucocorticoids Failed to Improve Infants Heart Surgery Outcomes, Study Warns

Researchers are warning doctors to carefully consider giving Medrol or other glucocorticoids to infants before heart surgery, since the common practice does not appear to improve death rates associated with the procedure and may actually increased the risk of hyperglycemia.

In a study published this week in the New England Journal of Medicine, researchers from the Duke Pediatric and Congenital Heart Center focused on whether the use of infants glucocorticoid steroids before heart surgery improved outcomes or reduced the risk of death.

Infants undergoing heart surgery are often given methylprednisolone, sold under brand names like Medrol, to reduce inflammation and reduce the risk of negative outcomes. One older study indicated that it may also help reduce the risk of death. However, these new findings indicate that infants given glucocorticoids fared no better than infants given a placebo, but may actually face unintended risks from the treatment.

Researchers conducted a randomized, placebo-controlled, registry-based trial involving 1,263 infants less than a year old who were undergoing heart surgery with cardiopulmonary bypass at 24 sites. The medical sites were a part of the Society of Thoracic Surgeons Congenital Heart Surgery Database.

Infants were randomly assigned to receive prophylactic methylprednisolone, 30 mg per kilogram of body weight, or a placebo, administered into the cardiopulmonary-bypass pump-priming fluid.

Researchers focused on outcomes of death, heart transplant or any of 13 major complications. However, the findings produced conflicting results.

There was no difference of increased risk of death between infants who received steroids and those that received the placebo. Also, the steroids failed to reduce the risk of complications or heart transplantation.

The findings also indicated infants who received Medrol were more likely to have high blood glucose levels, which is a stress response to surgery. Nearly 20% of infants in the steroid group required postoperative insulin as a result, compared to 7% in the placebo group.

“Among infants undergoing surgery with cardiopulmonary bypass, prophylactic use of methylprednisolone did not significantly reduce the likelihood of a worse outcome in an adjusted analysis and was associated with postoperative development of hyperglycemia warranting insulin in a higher percentage of infants than placebo,” the researchers concluded.

Medrol May Still Have Some Use for Certain Infants

However, after researchers conducted a second analysis of the data, the infants given the steroid had a small, reduced risk of death. The risk of bleeding after surgery and requiring a second operation was also lower among infants in the steroid group.

The improvement wasn’t statistically significant, but there may be a small benefit to giving some infants steroids, researchers suggested.

However, they noted the majority of the findings point to no improved outcomes. Researchers said, at this time, doctors should continue to use them on infants undergoing heart surgery for the small added benefit.

The researchers explained doctors may want to focus on how they use them and on which infants. Administration should be more targeted for infants who could see a potential benefit. It should also be focused on those undergoing less complex operations who face a reduced risk of complication overall. The steroids may also be better suited for infants with longer cardiopulmonary bypass times, and those who were born prematurely.