Abstract 11041: Use of Digoxin is Associated With Reduced Interstage Mortality: Results From the Pediatric Heart Network Single Ventricle Reconstruction Trial

Abstract

Introduction: Despite medical and surgical advances over the past few decades, mortality for infants with single ventricle congenital heart disease remains as high as 8-12% during the interstage period, the time between discharge after the Norwood procedure and before the stage II palliation. The objective of our study was to determine the effect of digoxin use on interstage mortality in infants with single ventricle congenital heart disease. Hypothesis: We hypothesized that digoxin would be associated with lower interstage mortality. Methods: We conducted a retrospective cohort study using the Pediatric Heart Network Single Ventricle Reconstruction Trial public use dataset, which includes data on infants with single right ventricle congenital heart disease randomized to receive either a Blalock-Taussig shunt or right ventricle-to-pulmonary artery shunt during the Norwood procedure at 15 institutions in North America from 2005-2008. Parametric survival models were used to compare the risk of interstage mortality between those discharged to home on digoxin vs. those discharged to home not on digoxin, adjusting for center volume, ascending aorta diameter, shunt type, and socioeconomic status. Further comparisons were made to compare the number of other adverse events in the two groups. Results: Of the 330 infants eligible for this study, 102 (31%) were discharged home on digoxin. Interstage mortality for those not on digoxin was 12.3%, compared to 2.9% among those on digoxin (Figure), with a number needed to treat of 11 patients to prevent one death. The adjusted hazard ratio was 3.5 (95%CI 1.1-11.7, p=0.04). There were no differences in complications between the two groups during the interstage period. Conclusions: Digoxin use in infants with single ventricle congenital heart disease is associated with significantly reduced interstage mortality and should be considered for all such infants unless otherwise contraindicated.