Original articles: Cardiovascular
Randomized controlled study of inhaled nitric oxide after operation for congenital heart disease

https://doi.org/10.1016/S0003-4975(00)01312-6Get rights and content

Abstract

Background. Inhaled nitric oxide selectively decreases pulmonary vascular resistance. This study was performed to determine whether inhaled nitric oxide decreases the incidence of pulmonary hypertensive crises after corrective procedures for congenital heart disease.

Methods. Patients with a systolic pulmonary arterial pressure of 50% or more of the systolic systemic arterial pressure during the early postoperative period were randomized to receive 20 parts per million inhaled nitric oxide (n = 20) or conventional therapy alone (n = 20). Acute hemodynamic and blood gas measurements were performed at the onset of therapy. The efficacy of sustained therapy was determined by comparing the number of patients in each group who experienced a pulmonary hypertensive crisis.

Results. In comparison to controls, there were no significant differences in the baseline and 1-hour measurements of patients who were treated with nitric oxide. Four patients in the control group and 3 patients in the nitric oxide group experienced a pulmonary hypertensive crisis.

Conclusions. Nitric oxide did not substantially improve pulmonary hemodynamics and gas exchange immediately after operation for congenital heart disease. Nitric oxide also failed to significantly decrease the incidence of pulmonary hypertensive crises.

Section snippets

Material and methods

This study was approved by the Research and Human Subjects Committee of Primary Children’s Medical Center (July 29, 1993). Informed consent was obtained from the patients (≥ 18 years of age) or their parents. An Investigational New Drug application for the use of inhaled nitric oxide for postoperative pulmonary hypertension was approved by the US Food and Drug Administration (March 12, 1993). This study was performed from August 1993 to August 1999.

Patients

Nineteen patients were enrolled into each patient group. Two patients were enrolled on two separate occasions; both underwent operation for pulmonary venous obstruction after an initial repair of total anomalous pulmonary venous return. The patients’ diagnoses are listed in Table 1. A similar number of patients had Down syndrome in each group. Table 1 also indicates that several patients in each group had radiographic evidence of lung disease before operation. The median age was 6 months

Comment

In this study, nitric oxide did not acutely improve pulmonary hemodynamics and arterial blood gases in comparison to conventional therapy. Nitric oxide also failed to significantly decrease the incidence of pulmonary hypertensive crises. This study is clearly limited by its size; however, it provides an estimate of the number of patients needed to exclude, with greater power, the possibility that inhaled nitric oxide prevents clinically significant pulmonary hypertensive crises after operation

Acknowledgements

We thank each member of the Department of Respiratory Care Services at Primary Children’s Medical Center who assisted in the delivery of inhaled nitric oxide.

References (21)

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