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Reexploring the STRESS Trial: Subgroup Postoperative Outcomes Following Methylprednisolone for Infant Heart Surgery.
Sudeep D Sunthankar1, Kevin D Hill2, Jeffrey P Jacobs3
1Division of Pediatric Cardiology and Center for Pediatric Precision Medicine, Department of Pediatrics, Vanderbilt University Medical Center, 2220 Children's Way; Suite 5230, Nashville, TN, 37232, USA. sudeep.sunthankar@vumc.org.
Pediatric Cardiology
|May 2, 2025
Summary
Intraoperative methylprednisolone did not improve major outcomes in infant heart surgery but reduced reinterventions in specific subgroups. Further research is needed for these patient populations.
Area of Science:
- Pediatric Cardiac Surgery
- Pharmacology
- Critical Care Medicine
Background:
- Infant heart surgery carries significant risks, including mortality and complications.
- The use of corticosteroids like methylprednisolone aims to reduce systemic inflammation post-surgery.
- Optimal steroid use in this vulnerable population remains under investigation.
Purpose of the Study:
- To assess the association between intraoperative methylprednisolone and specific postoperative outcomes in infants undergoing heart surgery.
- To analyze these outcomes across various patient subgroups.
Main Methods:
- Subpopulation analyses from a double-blind, randomized, placebo-controlled trial (The Steroids to Reduce Systemic Inflammation after Infant Heart Surgery trial).
- Infants under 1 year old undergoing heart surgery with cardiopulmonary bypass were stratified by STAT Mortality Category, age, gestational age, and presence of chromosomal or syndromic diagnosis (CSD).
- Methylprednisolone was administered via cardiopulmonary bypass pump-priming fluid versus placebo.
Main Results:
- Methylprednisolone did not reduce the odds of death, transplant, or mechanical circulatory support in any subgroup.
- Fewer reinterventions were observed in patients receiving methylprednisolone within STAT Category 1-3 operations, term infants, and those without CSD.
- No significant difference in hospital length of stay was found between groups.
Conclusions:
- Exploratory analyses suggest methylprednisolone is not associated with significant harm in infant heart surgery subgroups.
- Certain subpopulations, particularly those without chromosomal or syndromic diagnosis, may experience benefits from methylprednisolone regarding the composite outcome.
- Further underpowered studies indicate potential benefits in specific patient groups, warranting cautious consideration.

