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Ann Thorac Surg 2000;69:1913
© 2000 The Society of Thoracic Surgeons
a Cardiovascular Research Institute, Department of Pediatrics, University of California, San Francisco, 505 Pamassus Ave, Moffit 680, San Francisco, CA 94143-0106, USA
e-mail: jfineman{at}ped.card.ucsf.edu
Numerous animal and human studies clearly demonstrate that inhaled nitric oxide (NO) is a potent, selective, and endothelium-independent pulmonary vasodilator [1]. For these reasons, its use has been advocated in the care of children and adults with increased pulmonary vascular resistance secondary to heart disease. In the management of children with congenital heart disease, several indications have been advocated. These include its use in the pre-operative assessment of the vasodilatory capacity of the pulmonary circulation, its use in the post-operative assessment of reactive vs. anatomic pulmonary hypertension, and most commonly, its use in the peri-operative management of increased pulmonary arterial pressure [2]. However, what remains unclear is whether the use of inhaled NO improves the outcome of these children. In the current study, Day and colleagues randomized 40 children with post-operative pulmonary hypertension to receive inhaled NO or conventional therapy alone. They found that despite a mild decrease in pulmonary arterial pressure following initiation of inhaled NO, there were no differences in the incidence of pulmonary hypertensive crises or days on assisted ventilation and inotropic support.
Following several large, multi-centered, randomized trials that demonstrated a decreased need for extra-corporeal life support in subjects randomized to receive treatment, inhaled NO was recently approved by the Food and Drug Administration (FDA) for use in neonates with hypoxemic respiratory failure and persistent pulmonary hypertension [3]. Associated with this approval, we can expect an increase in the off-label usage of inhaled NO for patients with heart disease. Although many of the potential toxicities of inhaled NO, such as methemoglobenemia and nitrogen dioxide contamination, can be avoided by careful monitoring, others, such as potential lung injury and potential aberrations in endogenous NO activity during therapy, remain a concern. In addition, following FDA approval, the cost of administering inhaled NO has now become significant. Day and colleagues should be applauded for their attempt to begin to address the efficacy of inhaled NO in children with congenital heart disease with the use of a randomized trial. This represents one of the few attempts at randomization in this critically ill patient population. As the authors state, the current study is limited by sample size, cross over design, and the intravenous coadministration of NO donors. However, it is clear from this investigation that despite clinical impressions, an improvement in patient outcome is not obvious with inhaled NO, and large numbers of high-risk patients will be needed to determine potential changes in outcome. It is now imperative, that we continue Day and colleagues initial effort, and answer several important questions related to inhaled NO use in children with congenital heart disease, with large, multi-centered, randomized trials.
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