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Methylprednisolone for Infant Heart Surgery: Subpopulation Analyses of a Randomized Controlled Trial
Sudeep D Sunthankar1, Kevin D Hill2, Jeffrey P Jacobs3
1Thomas P. Graham Jr. Division of Pediatric Cardiology and Center for Pediatric Precision Medicine, Department of Pediatrics, Monroe Carell Jr. Children's Hospital at Vanderbilt and Vanderbilt University Medical Center, Nashville, TN.
Insights
Prophylactic intraoperative methylprednisolone in infant heart surgery showed benefits like reduced hydrocortisone use but also risks including increased thrombosis in premature infants and higher blood glucose. Certain infant groups may benefit without significant harm.
Area of Science:
- Cardiology
- Pediatric Surgery
- Pharmacology
Background:
- Infant heart surgery carries risks of systemic inflammation and complications.
- Prophylactic corticosteroids are used to mitigate these risks.
- The STRESS trial investigated methylprednisolone's efficacy and safety.
Purpose of the Study:
- To evaluate the benefits and harms of prophylactic intraoperative methylprednisolone in specific subpopulations of infants undergoing heart surgery.
- To identify subgroups that may benefit from or be harmed by this intervention.
Main Methods:
- Subpopulation analyses from the STRESS trial, a double-blind, randomized, placebo-controlled study.
- Infants (<1 year) undergoing heart surgery with cardiopulmonary bypass were stratified by STAT category, age, gestational age, and CSD.
- Methylprednisolone (30 mg/kg) or placebo was administered during cardiopulmonary bypass.
Main Results:
- Methylprednisolone reduced postoperative hydrocortisone use in neonates, STAT categories 1-5, term infants, and those without CSD.
- Lower thrombosis rates were observed in neonates and term infants receiving methylprednisolone.
- Adverse effects included increased thrombosis in premature infants, increased AKI in neonates and STAT 1-3 groups, and elevated peak blood glucose and insulin levels across subgroups.
Conclusions:
- Prophylactic methylprednisolone demonstrated both benefits (reduced hydrocortisone, no increased infection) and harms (increased glucose, potential AKI risk).
- Specific subpopulations may benefit from its use, but careful consideration of risks is necessary.
- Further research may refine patient selection for optimal outcomes.
Objectives:
Evaluate benefits and harms of prophylactic intraoperative methylprednisolone in subpopulations undergoing infant heart surgery.
Design:
Subpopulation analyses of The Steroids to Reduce Systemic Inflammation after Infant Heart Surgery (STRESS) trial, a double-blind randomized placebo-controlled trial.
Setting:
Twenty-four congenital heart centers.
Patients:
Infants (< 1 yr old) undergoing heart surgery with cardiopulmonary bypass. Patients stratified by Society of Thoracic Surgeons-European Association for Cardio-Thoracic Surgery Congenital Heart Surgery (STAT) mortality category, age, gestational age, and presence of chromosomal or syndromic diagnosis (CSD).
Interventions:
Methylprednisolone (30 mg/kg) vs. placebo administered into cardiopulmonary bypass pump-priming fluid.
Measurements And Main Results:
Six postoperative outcomes: steroid use, acute kidney injury (AKI), thrombosis, infections, prolonged mechanical ventilation, peak blood glucose levels, and insulin exposure. One thousand two hundred patients received methylprednisolone or placebo. Beneficial effects associated with methylprednisolone included reduced use of postoperative hydrocortisone in neonates (odds ratio [OR], 0.39 [0.25-0.60]), both STAT category groups (1-3: OR, 0.64 [0.46-0.89]; 4-5: OR, 0.57 [0.34-0.97]), term infants (OR, 0.63 [0.47-0.83]), and those without CSD (OR, 0.63 [0.46-0.86]). Methylprednisolone was associated with lower thrombosis occurrence among neonates (OR, 0.37 [0.16-0.87]) and term infants (OR, 0.38 [0.19-0.75]). Adverse associations included increased thrombosis among premature infants ( p = 0.005), increased AKI among neonates (OR, 1.55 [1.02-2.37]) and those following STAT category 1-3 operations (OR, 1.34 [1.02-1.75]), and increased peak blood glucose levels and insulin exposure (all subgroups; p < 0.001). No increase in overall infection or reduction in prolonged mechanical ventilation with methylprednisolone.
Conclusions:
Both beneficial and adverse associations were observed with prophylactic methylprednisolone. Reduction in postoperative hydrocortisone administration and absence of increased infection rates are arguments favoring prophylactic methylprednisolone use. Methylprednisolone was associated with increased peak blood glucose levels and a neutral to harmful association with odds of AKI. These data suggest certain subpopulations may benefit from prophylactic intraoperative methylprednisolone without significant harm.
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