Methylprednisolone does not reduce risk of adverse outcomes in infants undergoing heart surgery

Administration of perioperative methylprednisolone did not reduce the risk of adverse clinical outcomes in infants undergoing heart surgery with cardiopulmonary bypass (CPB), according to the STRESS trial. However, secondary and subgroup analyses suggested that some patients receiving corticosteroids may benefit from this therapy, especially non-premature infants undergoing lower complexity operations or those with a longer cardiopulmonary bypass (CPB) time.

“Perioperative corticosteroids have been used for decades to treat the inflammatory response in patients undergoing heart surgery with cardiopulmonary bypass,” started Dr Kevin Hill (Duke Children’s Hospital & Health Center, NC, USA). “This inflammatory response is most severe in infants and neonates undergoing heart surgery as the total blood volume in these patients is relatively small compared with the bypass circuit.” However, the safety and efficacy of the use of perioperative corticosteroids have not been established in children undergoing heart surgery with CPB.

The pragmatic STRESS trial (NCT03229538), designed within a registry using the Society of Thoracic Surgeons Congenital Heart Surgery Database (STS-CHSD), randomised 1,200 infants (<1 year) undergoing heart surgery with CPB 1:1 to methylprednisolone (30mg/kg) or placebo [1]. The primary outcome was a ranked composite of adverse clinical outcomes, ranging from operative mortality to post-operative length of stay.

No significant difference observed was observed with methylprednisolone versus placebo for the primary composite outcome (adjusted OR 0.86; 95% CI 0.71–1.05; P=0.14). The risk factor-unadjusted analysis of the primary outcome, which was a secondary outcome of the study, revealed a clinical benefit of the methylprednisolone arm over the placebo arm (OR 0.82; P=0.047). Also, fewer participants in the intervention arm experienced bleeding requiring operation (OR 0.34; P=0.016). The safety analysis revealed that participants in the methylprednisolone group were more likely to receive post-operative insulin than participants in the placebo group (P<0.001). On the other hand, participants in the methylprednisolone group were less likely to receive post-operative hydrocortisone (P=0.004), which is most commonly administered to patients with low cardiac output syndrome.

Overall. the trial did not demonstrate the superiority of methylprednisone and the observation of more insulin use suggests further studies are needed to evaluate the optimal approach. Dr Stephanie Fuller, a discussant of the trial, congratulated Dr Hill on the successful design of a ‘trial within a registry’, significantly reducing the time, effort, and cost that is usually associated with randomised controlled trials. “This is truly the future of paediatric randomised trials,” Dr Fuller concluded.

1. 1. Hill KD, et al. Steroids to reduce systemic inflammation after infant surgery: The STRESS trial. LBS.03, AHA Scientific Sessions 2022, 05–07 November Chicago, USA.

 

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Posted on 11 January, 2023