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Intraoperative corticosteroid fails to show benefit in neonates undergoing cardiac surgery
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While intraoperative methylprednisolone failed to show a significant benefit for mortality and morbidity outcomes in neonates undergoing cardiopulmonary bypass, it may yet yield some value for those undergoing palliative procedures.
According to a study published in the Journal of the American College of Cardiology, administration of intraoperative methylprednisolone 30 mg/kg for neonates receiving cardiopulmonary bypass failed to show a significant benefit on the incidence of the primary composite endpoint, which included death, mechanical circulatory support, cardiac arrest, hepatic injury, renal injury or rising lactate level.
However, researchers found a significant benefit of using prophylactic methylprednisolone in patients undergoing palliative procedures. Moreover, they observed significant interaction between treatment effect and center.
“Intraoperative administration of methylprednisolone does not uniformly enhance post-operative recovery of neonates undergoing cardiopulmonary bypass but may be beneficial in certain patients or under certain circumstances,” Eric M. Graham, MD, FAHA, FACC, chief of pediatric cardiology at the Medical University of South Carolina, told Cardiology Today. “Although this work does not resolve the debate about steroids in this population, It does however highlight the critical role center differences and practice variation can play in our studies and ultimately in patient outcomes.”
In this double-blind, randomized controlled trial of methylprednisolone vs. placebo, researchers analyzed outcomes among 176 neonates undergoing cardiopulmonary bypass at two centers (mean age at time of surgery, 8.6 days; 60% male; mean weight, 3.3 kg). The neonates were randomly assigned to methylprednisolone (n = 81) or placebo (n = 95) after anesthesia.
Researchers found that 33% of the methylprednisolone group and 42% of the placebo group reached the primary endpoint (OR = 0.63; 95% CI, 0.31-1.3; P = .21).
According to the study, methylprednisolone showed a protective effect among patients at one of the centers (OR = 0.35; 95% CI, 0.15-0.84; P = .02), but not at the other center (OR = 5.13; 95% CI, 0.85-30.90; P = .07).
“Although the effect of methylprednisolone on the primary endpoint was negative, the beneficial effect at [one] center was impressive,” the authors wrote. “Methylprednisolone resulted in a reduction in the incidence of the composite endpoint of death and objective signs of inadequate cardiac output at 30 days and hospital discharge and in the incidence of [low cardiac output syndrome] and resulted in a lower inotropic requirement.”
Additionally, prophylactic methylprednisolone was associated with a reduction in vasoactive inotropic requirements and also in incidence of the composite endpoint in neonates undergoing palliative operations (OR = 0.38; 95% CI, 0.15-0.99; P = .048).
“[At] the center enrolling the majority of patients (133 of 176, 76%), methylprednisolone was protective for the primary composite endpoint overall and for palliative operations,” Graham said. “Methylprednisolone also reduced the incidence of low cardiac output, vasoactive/inotropic requirements and treatment with post-operative open-label steroids at one center but not the other. These findings suggest that technical factors or support strategies may overwhelm the effect of steroids and provides insight into why it has been so difficult to determine if steroids are beneficial in this population despite more than a half century of investigation.” – by Scott Buzby
Disclosures: This work was supported by grant HL112968 from the National Heart, Lung, and Blood Institute. This work is solely the responsibility of the authors and does not necessarily represent the official views of the National Heart, Lung, and Blood Institute or National Institutes of Health. Graham has served as a research consultant to Bayer. The other authors reported no relevant financial disclosures.
Perspective
Back to TopMyriam Almeida-Jones, MD, FAAP
Despite the widespread use of corticosteroids in pediatric cardiac surgery, there is significant practice variability and conflicting data on the effects of empiric corticosteroid use in pediatric patients with congenital heart disease undergoing surgery with cardiopulmonary bypass.
Graham and colleges set out to evaluate whether a single preoperative dose of methylprednisolone significantly improves postoperative course in neonates undergoing cardiac surgery at two medical centers. This randomized, placebo-controlled trial failed to show that all neonates benefit from empiric intraoperative methylprednisolone. However, neonates who received methylprednisolone prior to undergoing palliative surgery with cardiopulmonary bypass at one of the centers had significantly improved clinical outcome compared with those who received placebo. While these data are not generalizable to all neonates, it does provide insight into the effects of system practice variability on clinical outcome.
Center-specific management strategies and patient characteristics may confer outcome advantage that outweighs the effects of methylprednisolone in neonates undergoing surgery with cardiopulmonary bypass. Larger, multi-institutional trials are still needed to tease out the effects of corticosteroids and complex system practice variations in the management of pediatric patients with congenital heart disease requiring surgery.
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