title: Multicenter midterm follow-up results using the gore septal occluder for atrial septal defect closure in pediatric patients.
abstract: OBJECTIVE
  To assess the safety and efficacy of the Gore Septal Occluder (GSO) used for device-closure of significant secundum-type atrial septal defects (ASD II) focusing on pediatric patients.
  
  
  BACKGROUND
  The GSO is a patch-like double disc device. Due to its design, it is assumed to be safe, even when implanted in ASDs with deficient retro-aortic rims.
  
  
  METHODS
  Multicenter retrospective analysis of consecutive children and adolescents with a GSO in situ for at least 12 months according to a 1- to 4-year midterm follow-up.
  
  
  RESULTS
  Hundred and seventy three pediatric patients were enrolled. At implantation, median age was 6 years (range 0.7-17.9), median body weight and length were 21 kg (6.4-95) and 119 cm (65-193). Median follow-up period was 20 months (range 12-51). ASD anatomy was comprised of single defects in 131 patients (76%), multi-fenestrated defects in 42 (24%), and deficient retro-aortic rims in 33 (19%). Follow-up confirmed an overall closure-rate of 95.4%. Small residual shunts were reported in eight patients (4.6%) without need for any re-intervention. Complications were classified as minor events both during the initial procedure (9 patients, 5.2%) and on follow-up (another 9 patients), including transient AV block II in three patients (1.8%) and four snare-retrievals (2.4%) during the initial procedure.
  
  
  CONCLUSIONS
  Periprocedural and midterm follow-up data have shown the GSO to be effective and safe for ASD device closure in children and adolescents. GSO may be considered the first-choice device in deficient retro-aortic rims and multi-fenestrated defects, when covering most of the atrial septum is necessary. © 2016 Wiley Periodicals, Inc.
authors.affiliation: Department of Congenital Heart Defects and Pediatric Cardiology, Heart Center, University of Freiburg, Freiburg, Germany.
authors.forename: Jochen
authors.initials: J
authors.lastname: Grohmann
authors.affiliation: Department of Congenital Heart Defects and Pediatric Cardiology, Heart Center, University of Freiburg, Freiburg, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Wildberg
authors.affiliation: Department of Cardiology, German Pediatric Heart Center, Sankt Augustin, Germany.
authors.forename: Peter
authors.identifier: http://orcid.org/0000-0002-2256-1517
authors.initials: P
authors.lastname: Zartner
authors.affiliation: Department of Pediatric Cardiology and Congenital Heart Disease, University Children's Hospital, University Medicine Mainz, Mainz, Germany.
authors.forename: Tariq
authors.initials: T
authors.lastname: Abu-Tair
authors.affiliation: Department for Pediatric Cardiology and Congenital Heart Disease, Heart Center Duisburg, Duisburg, Germany.
authors.forename: Gleb
authors.initials: G
authors.lastname: Tarusinov
authors.affiliation: Department of Pediatric Cardiology, Medical University of Vienna, Vienna, Austria.
authors.forename: Erwin
authors.initials: E
authors.lastname: Kitzmüller
authors.affiliation: Faculty of Medicine, Clinical Trials Unit, Medical Center - University of Freiburg, Freiburg, Germany.
authors.forename: Claudia
authors.initials: C
authors.lastname: Schmoor
authors.affiliation: Department of Congenital Heart Defects and Pediatric Cardiology, Heart Center, University of Freiburg, Freiburg, Germany.
authors.forename: Brigitte
authors.initials: B
authors.lastname: Stiller
authors.affiliation: Department of Pediatric Cardiology and Congenital Heart Disease, University Children's Hospital, University Medicine Mainz, Mainz, Germany.
authors.forename: Christoph
authors.initials: C
authors.lastname: Kampmann
mesh_terms: D000293:Adolescent; D000367:Age Factors; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D002648:Child; D002675:Child, Preschool; D018618:Echocardiography, Doppler, Color; D017548:Echocardiography, Transesophageal; D005260:Female; D005500:Follow-Up Studies; D005858:Germany; D006344:Heart Septal Defects, Atrial / Q000000981:diagnostic imaging / Q000628:therapy*; D006801:Humans; D007223:Infant; D008297:Male; D011474:Prosthesis Design; D012189:Retrospective Studies; D012307:Risk Factors; D055989:Septal Occluder Device; D013997:Time Factors; D016896:Treatment Outcome
keywords: cardiac intervention; congenital heart disease; device closure; follow-up; occlude; pediatric; secundum-type atrial septal defect