Published online March 1, 2006
PEDIATRICS Vol. 117 No. 3 March 2006, pp. S40-S46 (doi:10.1542/peds.2005-0620G)

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SUPPLEMENT ARTICLE

Summary Proceedings From the Cardiology Group on Postoperative Cardiac Dysfunction

Stephen J. Roth, MD, MPH^a, Ian Adatia, MBChB^b, Gail D. Pearson, MD, ScD^c and Members of the Cardiology Group

^a Department of Pediatrics, Stanford University School of Medicine, Division of Pediatric Cardiology, Stanford, California
^b Department of Pediatrics, School of Medicine, University of California, San Francisco Children’s Hospital, San Francisco, California
^c Division of Heart and Vascular Diseases, National Heart, Lung, and Blood Institute, National Institutes of Health, Department of Health and Human Services, Bethesda, Maryland

As many as one third of the 35000 to 40000 infants born in the United States each year with significant congenital heart defects require surgery before the first year of life. Intraoperative support techniques, including cardiopulmonary bypass, can precipitate a complex, systemic inflammatory response that impairs the function of multiple organs and results in more hemodynamic instability and early morbidity in newborns than in older infants and children. Vasoactive agents are routinely used in the postoperative management of these patients either to treat or prevent hemodynamic instability and low cardiac output. However, the effectiveness of vasoactive agents used either individually or in combination in achieving specific therapeutic goals such as maintenance of a minimum cardiac index or arteriovenous oxygen saturation difference has not been systematically evaluated in preterm and term neonates. In addition, there are insufficient safety data for these agents in preterm and term neonates, both as individual agents and in combination. This article proposes a framework for developing prospective clinical studies to determine the efficacy of different vasoactive agents to promote adequate cardiac output and hemodynamic stability after neonatal cardiac surgery. The framework provides an overview of the issues relevant to the design of prospective clinical studies of vasoactive agents in the newborn patient population undergoing cardiac surgery. The issues identified by the cardiology group illustrate the difficulty of designing and executing clinical trials in vulnerable pediatric populations with limited numbers of patients, especially when standard practice is widely believed to be beneficial despite the lack of rigorous data to support such practice.

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Key Words: neonates • congenital heart disease • cardiopulmonary bypass surgery • postoperative myocardial dysfunction • vasoactive agents

Abbreviations: CPB—cardiopulmonary bypass • FDA—Food and Drug Administration • BNP—brain natriuretic peptide

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Accepted Oct 17, 2005.

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