title: The influence of deficient retro-aortic rim on technical success and early adverse events following device closure of secundum atrial septal defects: An Analysis of the IMPACT Registry®.
abstract: BACKGROUND
  Concern regarding aortic erosion has focused attention on the retro-aortic rim in patients undergoing device closure of atrial septal defects (ASD), but its effect on early outcomes is not well studied.
  
  
  METHODS
  A multicenter retrospective cohort study of patients undergoing device occlusion of ASD between 1/2011-10/2014 was performed, using data from the IMproving Pediatric and Adult Congenital Treatment Registry. Subjects were divided between those with retro-aortic rim <5 and ≥5 mm. Primary outcomes were technical failure and major early adverse events. Case times were measured as surrogates of technical complexity. The effect of deficient retro-aortic rim on primary outcomes was assessed using hierarchical logistic regression, adjusting for other suspected covariates and assessing whether they represent independent risk factors RESULTS: 1,564 subjects (from 77 centers) were included, with deficient retro-aortic rim present in 40%. Technical failure occurred in 91 subjects (5.8%) and a major early adverse event in 64 subjects (4.1%). Adjusting for known covariates, the presence of a deficient retro-aortic rim was not significantly associated with technical failure (OR: 1.3, 95% CI: 0.9-2.1) or major early adverse event (OR: 0.7, 95% CI: 0.4-1. 2). Total case (P = 0.01) and fluoroscopy time (P = 0.02) were greater in subjects with deficient rim, but sheath time was not significantly different (P = 0.07). Additional covariates independently associated with these outcomes were identified.
  
  
  CONCLUSIONS
  Deficient retro-aortic rim was highly prevalent but not associated with increased risk of technical failure or early adverse events. Studies with longer follow-up are necessary to assess other outcomes, including device erosion. © 2016 Wiley Periodicals, Inc.
authors.affiliation: Division of Cardiology, Children's National Medical Center, George Washington University School of Medicine and Health Sciences.|Department of Pediatrics, George Washington University School of Medicine and Health Sciences.
authors.forename: Michael L
authors.initials: ML
authors.lastname: O'Byrne
authors.affiliation: Division of Cardiology, The Children's Hospital of Philadelphia.|Department of Pediatrics, Perelman School of Medicine, The University of Pennsylvania, Philadelphia.
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: Gillespie
authors.affiliation: Mid America Heart Institute St. Luke's Health System.
authors.forename: Kevin F
authors.initials: KF
authors.lastname: Kennedy
authors.affiliation: Division of Cardiology, The Children's Hospital of Philadelphia.|Department of Pediatrics, Perelman School of Medicine, The University of Pennsylvania, Philadelphia.
authors.forename: Yoav
authors.initials: Y
authors.lastname: Dori
authors.affiliation: Division of Cardiology, The Children's Hospital of Philadelphia.|Department of Pediatrics, Perelman School of Medicine, The University of Pennsylvania, Philadelphia.
authors.forename: Jonathan J
authors.initials: JJ
authors.lastname: Rome
authors.affiliation: Division of Cardiology, The Children's Hospital of Philadelphia.|Department of Pediatrics, Perelman School of Medicine, The University of Pennsylvania, Philadelphia.|Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine at the University of Pennsylvania.
authors.forename: Andrew C
authors.initials: AC
authors.lastname: Glatz
mesh_terms: D000293:Adolescent; D006328:Cardiac Catheterization / Q000009:adverse effects* / Q000295:instrumentation; D002648:Child; D002675:Child, Preschool; D005260:Female; D006344:Heart Septal Defects, Atrial / Q000000981:diagnostic imaging / Q000453:epidemiology / Q000628:therapy*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D016015:Logistic Models; D008297:Male; D015999:Multivariate Analysis; D016017:Odds Ratio; D015995:Prevalence; D012042:Registries; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D055989:Septal Occluder Device; D013997:Time Factors; D017211:Treatment Failure; D014481:United States / Q000453:epidemiology; D055815:Young Adult
keywords: heart catheterization; outcomes research; pediatric cardiology