Intraoperative Steroid Use and Outcomes Following the Norwood Procedure

Abstract

Objective Data supporting the use of perioperative steroids during cardiac surgery are conflicting and most pediatric studies have been limited by small sample sizes and/or diverse cardiac diagnoses. The objective of this study was to determine if intraoperative steroid administration improved outcomes following the Norwood procedure. Design A retrospective analysis was performed on the 549 neonates who underwent a Norwood procedure in the publicly available datasets from the Pediatric Heart Network’s Single Ventricle Reconstruction (SVR) trial. Groups were compared to determine if outcomes differed between intraoperative steroid recipients (n=498, 91%) and non-recipients (n=51, 9%). Results Baseline characteristics and intraoperative variables were similar between groups with the exception of a shorter duration of cross clamp and cardiopulmonary bypass time in the group that received steroids. Subjects who did not receive intraoperative steroids had improved hospital survival (94% vs 83%, p=0.03), but longer intensive care unit stays (16 days (IQR 12–33) vs 14 days (IQR 9–28), p=0.04) and hospital stays (29 days (IQR 21–50) vs 23 days (IQR 15–40, p=0.01) than steroid recipients. In multivariate analysis lengths of stay associations were no longer significant but hospital survival trended towards favoring the non-steroids group with an odds ratio of 3.52 (95% confidence interval 0.98–12.64, p=0.054). Conclusions In the large multi-centered SVR trial there was widespread use of intraoperative steroids. Intraoperative steroid administration was not associated with an improvement in outcomes and may be associated with a reduction in hospital survival in neonates undergoing the Norwood procedure. This study highlights the need for a randomized control trial.

Study protocol: NITric oxide during cardiopulmonary bypass to improve Recovery in Infants with Congenital heart defects (NITRIC trial): a randomised controlled trial

“…At the same time, this age group is exposed to CPB during a vulnerable phase of brain development13–15 and remains at highest risk of suffering neurological impairments16 due to acute brain injury occurring within the context of LCOS. Recent trials to reduce LCOS during cardiac surgery for CHD testing interventions such as steroids17 have not demonstrated consistent benefit 18. Given the adverse effects of CPB on early recovery and long-term neurodevelopment, there remains an urgent need for clinical trials evaluating novel therapies to address these problems 5…”

Corticosteroids in Pediatric Heart Surgery: Myth or Reality

“…In the neonate subgroup analyses, no difference in clinical outcomes was detected. Using datasets from a clinical trial (the Pediatric Heart Network's Single Ventricle Reconstruction trial), on neonates that had the Norwood procedure, Elhoff et al [ 47 ] compared the effect of intraoperative corticosteroid administration in 498 recipients with 51 non-recipients and found in the multivariate analysis no effect of corticosteroid on lengths of stay but a trend toward better hospital survival in non-recipients. This is one of the few studies where the authors have also looked at the neurodevelopment outcomes at 14 months and found no difference.…”

The Optimal Timing of Stage 2 Palliation for Hypoplastic Left Heart Syndrome

“…Our results harmonize with a recent study of intraoperative steroid use during the Norwood in the SVR Trial, in which intraoperative steroids were associated with greater hospital mortality in a multivariable logistic regression. 39 In a meta-analysis including 232 patients, intraoperative steroid use was not associated with significant reductions in morbidity or mortality in children undergoing cardiac surgery. 40 However, other published studies from the last decade present contradictory results.…”