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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.
Insights
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.
Abstract:
Objective Assess the association between intraoperative methylprednisolone and specific postoperative outcomes among subgroups undergoing infant heart surgery.
Design:
Subpopulation analyses of The Steroids to Reduce Systemic Inflammation after Infant Heart Surgery trial, a double-blind randomized placebo-controlled trial.
Setting:
24 congenital heart centers.
Patients:
Infants (< 1 year 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) versus placebo administered into cardiopulmonary bypass pump-priming fluid.
Measurements And Main Results:
Outcomes included death, heart transplantation, mechanical circulatory support, reinterventions, and hospital length of stay. Ranked composite outcome (death, transplant, or one of 13 major complications) was compared between placebo and methylprednisolone for each subgroup using the win ratio. Methylprednisolone did not reduce odds of death, transplant, or mechanical circulatory support for any subgroup. Those receiving methylprednisolone had fewer catheterization or surgical reinterventions after STAT Category 1-3 operations [OR 0.50 (0.29-0.86)]; and fewer reoperations for bleeding among patients undergoing STAT Category 1-3 operations [OR 0.28 (0.09-0.87)], term infants [OR 0.30 (0.12-0.76)], and those without CSD [OR 0.22 (0.07-0.68)]. Length of stay was no different between methylprednisolone versus placebo. Those without chromosomal or syndromic diagnosis demonstrated a favorable association for methylprednisolone [win ratio 1.28 (1.01-1.61)] for the composite outcome.
Conclusion:
Exploratory subpopulation analyses, although underpowered, suggest that methylprednisolone is not associated with significant harm and may benefit certain subpopulations.
