Association of Digoxin With Interstage Mortality: Results From the Pediatric Heart Network Single Ventricle Reconstruction Trial Public Use Dataset

Abstract

BackgroundMortality for infants with single ventricle congenital heart disease remains as high as 8% to 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 association between digoxin use and interstage mortality in these infants.Methods and ResultsWe 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 to 2008. Parametric survival models were used to compare the risk of interstage mortality between those discharged to home on digoxin versus those discharged to home not on digoxin, adjusting for center volume, ascending aorta diameter, shunt type, and socioeconomic status. 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, with an adjusted hazard ratio of 3.5 (95% CI, 1.1–11.7; P=0.04). The number needed to treat to prevent 1 death was 11 patients. There were no differences in complications between the 2 groups during the interstage period.ConclusionsDigoxin use in infants with single ventricle congenital heart disease is associated with significantly reduced interstage mortality.

Impact of protein-losing enteropathy in children who underwent the Fontan operation

“…Utilising data from the Pediatric Heart Network Single Ventricle Reconstruction Trial, Oster et al reported a reduced risk of interstage mortality among those receiving digoxin therapy with a reduction from 12.3%, compared to 2.9% among those on digoxin. 17 This protective impact of digoxin was also seen even among those with no history of arrhythmia. 18 Longer term follow-up questioned the net protective effect of digoxin.…”

Single-ventricle reconstruction 2.0: A closer look at our understanding of care for infants undergoing the Norwood procedure

“…Importantly, patients discharged on digoxin were found to have an HR for mortality 3.5-fold lower than those not taking digoxin. 23 The present SVR II update does not include data regarding longitudinal practice patterns. However, there are data from the National Pediatric Cardiology Quality Improvement Collaborative as well as ad-hoc data from the SVR trial that demonstrate persistent variability in the management of post-Norwood infants through Stage II.…”

Perspective. Digoxin for interstage single ventricle patients: What could possibly go wrong?

“…These interstage programs have been credited with substantially reducing the incidence of interstage mortality. 3 How might one explain these interesting findings? Brown et al in a study using outcomes data provided through the National Pediatric Cardiology Quality Improvement Collaborative (NPC-QIC) reported on outcomes of 544 Norwood survivors without documented arrhythmias, 22% of whom were discharged on digoxin.…”

“…This difference could not be explained by other factors evaluated by the investigators including underlying anatomy. 3 How might one explain these interesting findings? Both papers' authors note that in most centers there was variability in the percentage of patients treated with digoxin and that it is impossible to know the reasons for the use of the medication in specific patients in these retrospective series.…”