title: Association of Digoxin With Interstage Mortality: Results From the Pediatric Heart Network Single Ventricle Reconstruction Trial Public Use Dataset.
abstract: 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.
  
  
  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.
authors.affiliation: Children's Healthcare of Atlanta, GA (M.E.O., W.T.M.) Emory University School of Medicine, Atlanta, GA (M.E.O., M.K., C.M.C., W.T.M.).
authors.forename: Matthew E
authors.initials: ME
authors.lastname: Oster
authors.affiliation: Emory University School of Medicine, Atlanta, GA (M.E.O., M.K., C.M.C., W.T.M.).
authors.forename: Michael
authors.initials: M
authors.lastname: Kelleman
authors.affiliation: Emory University School of Medicine, Atlanta, GA (M.E.O., M.K., C.M.C., W.T.M.).
authors.forename: Courtney
authors.initials: C
authors.lastname: McCracken
authors.affiliation: University of Michigan Medical School, Ann Arbor, MI (R.G.O.).
authors.forename: Richard G
authors.initials: RG
authors.lastname: Ohye
authors.affiliation: Children's Healthcare of Atlanta, GA (M.E.O., W.T.M.) Emory University School of Medicine, Atlanta, GA (M.E.O., M.K., C.M.C., W.T.M.).
authors.forename: William T
authors.initials: WT
authors.lastname: Mahle
mesh_terms: D058366:Blalock-Taussig Procedure / Q000009:adverse effects / Q000401:mortality*; D002317:Cardiovascular Agents / Q000009:adverse effects / Q000627:therapeutic use*; D016208:Databases, Factual; D004077:Digoxin / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006330:Heart Defects, Congenital / Q000175:diagnosis / Q000401:mortality* / Q000628:therapy*; D006352:Heart Ventricles / Q000002:abnormalities / Q000187:drug effects* / Q000601:surgery*; D006801:Humans; D007223:Infant; D007226:Infant Mortality; D007231:Infant, Newborn; D008297:Male; D058327:Norwood Procedures / Q000009:adverse effects / Q000401:mortality*; D010351:Patient Discharge; D016032:Randomized Controlled Trials as Topic; D012189:Retrospective Studies; D012307:Risk Factors; D016019:Survival Analysis; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D004077:Digoxin
keywords: congenital; digoxin; heart defects; mortality; pediatrics; single ventricle