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

J Am Heart Assoc. 2016 Jan 13;5(1):e002566. doi: 10.1161/JAHA.115.002566.


Background: Mortality 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 results: 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 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.

Conclusions: Digoxin use in infants with single ventricle congenital heart disease is associated with significantly reduced interstage mortality.

Keywords: congenital; digoxin; heart defects; mortality; pediatrics; single ventricle.

MeSH terms

  • Blalock-Taussig Procedure / adverse effects
  • Blalock-Taussig Procedure / mortality*
  • Cardiovascular Agents / adverse effects
  • Cardiovascular Agents / therapeutic use*
  • Databases, Factual
  • Digoxin / adverse effects
  • Digoxin / therapeutic use*
  • Female
  • Heart Defects, Congenital / diagnosis
  • Heart Defects, Congenital / mortality*
  • Heart Defects, Congenital / therapy*
  • Heart Ventricles / abnormalities
  • Heart Ventricles / drug effects*
  • Heart Ventricles / surgery*
  • Humans
  • Infant
  • Infant Mortality
  • Infant, Newborn
  • Male
  • Norwood Procedures / adverse effects
  • Norwood Procedures / mortality*
  • Patient Discharge
  • Randomized Controlled Trials as Topic
  • Retrospective Studies
  • Risk Factors
  • Survival Analysis
  • Time Factors
  • Treatment Outcome


  • Cardiovascular Agents
  • Digoxin