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Methylprednisolone for Heart Surgery in Infants - A Randomized, Controlled Trial
Kevin D Hill1, Prince J Kannankeril1, Jeffrey P Jacobs1
1From the Duke Pediatric and Congenital Heart Center (K.D.H., J.W.T., J.S.L.) and the Duke Clinical Research Institute (K.D.H., S.M.O., J.L.K., D.S.G., J.S.L.) - both in Durham, NC; Vanderbilt University Medical Center, Nashville (P.J.K., H.S.B., D.P.B.); the University of Florida Congenital Heart Center, Gainesville (J.P.J., M.B.); Johns Hopkins University School of Medicine, Baltimore (M.L.J., B.M.); the Medical University of South Carolina, Charleston (E.M.G.); the UPMC Children's Hospital of Pittsburgh, Pittsburgh (B.B.); the Section of Pediatric Cardiac Anesthesiology, Texas Children's Hospital, Department of Anesthesiology, Baylor College of Medicine, Houston (A.R., D.F.V.), and the Division of Cardiology, Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas (R.B.); the University of Utah-Primary Children's Hospital, Salt Lake City (A.S.H.); the University of Southern California and the Heart Institute, Children's Hospital of Los Angeles - both in Los Angeles (S.R.K.); the University of Cincinnati, Cincinnati Children's Hospital Medical Center, Cincinnati (A.B.), the Division of Pediatric Cardiac Surgery, Heart Vascular and Thoracic Institute, Cleveland Clinic Children's, Cleveland (T.K.), and the Department of Cardiothoracic Surgery, Nationwide Children's Hospital, and Ohio State University, Columbus (P.I.M.) - all in Ohio; the Ann and Robert H. Lurie Children's Hospital of Chicago, Northwestern University Feinberg School of Medicine, Chicago (E.W.), and the Advocate Children's Heart Institute, Advocate Children's Hospital, Division of Pediatric Cardiac Critical Care, Oak Lawn (A.H.V.B.) - both in Illinois; the Division of Cardiovascular Surgery, Children's Minnesota, Minneapolis (D.O.); the Section of Pediatric Cardiothoracic Surgery, Washington University School of Medicine, St. Louis (P.E.); the Division of Cardiology, Department of Pediatrics, Heart Institute, Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (J.S.K.); Children's Wisconsin, Medical College of Wisconsin, Milwaukee (J.P.S.); and the Division of Pediatric Cardiology, New York-Presbyterian Hospital-Columbia University Irving Medical Center, New York (B.R.A.), and the University of Rochester Medical Center, Rochester (M.F.S.) - both in New York.
Insights
Prophylactic methylprednisolone did not significantly improve outcomes for infants undergoing heart surgery. The drug was associated with increased postoperative hyperglycemia requiring insulin treatment in infants.
Area of Science:
- Pediatric Cardiology
- Cardiothoracic Surgery
- Clinical Pharmacology
Background:
- Perioperative prophylactic glucocorticoids are commonly used but their efficacy in infants undergoing heart surgery with cardiopulmonary bypass remains unclear.
- The study addresses a critical knowledge gap in pediatric cardiac critical care and surgical outcomes.
Purpose of the Study:
- To determine the effectiveness of prophylactic methylprednisolone in improving outcomes for infants undergoing heart surgery with cardiopulmonary bypass.
- To evaluate the safety profile, specifically the incidence of hyperglycemia, associated with methylprednisolone use in this population.
Main Methods:
- A multicenter, prospective, randomized, placebo-controlled trial was conducted involving 1263 infants (<1 year) undergoing heart surgery with cardiopulmonary bypass.
- Infants received either methylprednisolone or placebo, with outcomes assessed using a ranked composite of death, heart transplantation, major complications, and length of stay.
- Registry data from the Society of Thoracic Surgeons Congenital Heart Surgery Database were utilized for outcome evaluation.
Main Results:
- The primary analysis showed no significant difference in the likelihood of a worse outcome between the methylprednisolone and placebo groups (adjusted odds ratio, 0.86; P=0.14).
- Secondary analyses suggested a potential benefit of methylprednisolone (unadjusted odds ratio, 0.82; win ratio, 1.15).
- However, infants receiving methylprednisolone had a significantly higher incidence of postoperative hyperglycemia requiring insulin (19.0% vs. 6.7%, P<0.001).
Conclusions:
- Prophylactic methylprednisolone did not significantly reduce the likelihood of adverse outcomes in infants undergoing heart surgery with cardiopulmonary bypass.
- The use of methylprednisolone was associated with an increased risk of postoperative hyperglycemia requiring insulin treatment.
- These findings suggest that the risks of methylprednisolone may outweigh the benefits in this specific patient population.
Background:
Although perioperative prophylactic glucocorticoids have been used for decades, whether they improve outcomes in infants after heart surgery with cardiopulmonary bypass is unknown.
Methods:
We conducted a multicenter, prospective, randomized, placebo-controlled, registry-based trial involving infants (<1 year of age) undergoing heart surgery with cardiopulmonary bypass at 24 sites participating in the Society of Thoracic Surgeons Congenital Heart Surgery Database. Registry data were used in the evaluation of outcomes. The infants were randomly assigned to receive prophylactic methylprednisolone (30 mg per kilogram of body weight) or placebo, which was administered into the cardiopulmonary-bypass pump-priming fluid. The primary end point was a ranked composite of death, heart transplantation, or any of 13 major complications. Patients without any of these events were assigned a ranked outcome based on postoperative length of stay. In the primary analysis, the ranked outcomes were compared between the trial groups with the use of odds ratios adjusted for prespecified risk factors. Secondary analyses included an unadjusted odds ratio, a win ratio, and safety outcomes.
Results:
A total of 1263 infants underwent randomization, of whom 1200 received either methylprednisolone (599 infants) or placebo (601 infants). The likelihood of a worse outcome did not differ significantly between the methylprednisolone group and the placebo group (adjusted odds ratio, 0.86; 95% confidence interval [CI], 0.71 to 1.05; P = 0.14). Secondary analyses (unadjusted for risk factors) showed an odds ratio for a worse outcome of 0.82 (95% CI, 0.67 to 1.00) and a win ratio of 1.15 (95% CI, 1.00 to 1.32) in the methylprednisolone group as compared with the placebo group, findings suggestive of a benefit with methylprednisolone; however, patients in the methylprednisolone group were more likely than those in the placebo group to receive postoperative insulin for hyperglycemia (19.0% vs. 6.7%, P<0.001).
Conclusions:
Among infants undergoing surgery with cardiopulmonary bypass, prophylactic use of methylprednisolone did not significantly reduce the likelihood of a worse outcome in an adjusted analysis and was associated with postoperative development of hyperglycemia warranting insulin in a higher percentage of infants than placebo. (Funded by the National Center for Advancing Translational Sciences and others; STRESS ClinicalTrials.gov number, NCT03229538.).
