title: Transcatheter closure of atrial septal defects in children and adolescents: single-center experience with the GORE® septal occluder.
abstract: OBJECTIVE
  Device closure of atrial septal defects (ASD II) is an alternative to surgery. ASD morphology and intracardiac relationships may influence device selection. Biocompatibility, techniques for closing large or multiple defects, and the risk of erosion are main issues in children
  
  
  BACKGROUND
  The GORE® Septal Occluder (GSO) is a non-self-centering device with a flat and conformable nitinol-frame covered with expanded polytetrafluoroethylene. We hereby evaluate our initial experience in children to demonstrate feasibility, efficacy, and safety.
  
  
  METHODS
  Single-center retrospective intention-to-treat analysis of GSO procedures in children and adolescents with hemodynamically significant ASD. All procedures were conducted under general anesthesia, fluoroscopy and transesophageal echocardiography. All defects were sized using stop-flow-technique. GSOs of 20-30 mm disc-diameter were implanted.
  
  
  RESULTS
  GSO implantation was attempted in 45 with technical success in 41 patients, median age 6 (range 3-17) years, bodyweight 19 (12-95) kg. Median balloon-sized diameter was 13 (8-19) mm resulting in a GSO-to-ASD-ratio of 2 (1.7-2.5). Deficient retro-aortic rims (<3 mm) were found in 12 patients, and 10 of these 12 defects could be closed. We observed no complications. Four extensive or multiple ASDs were not treated successfully with GSO. After retrieval, one was closed with a different device; three patients needed surgical therapy. The median follow-up of four (range 0.2-22) months was uneventful in all patients
  
  
  CONCLUSIONS
  We found the GSO device closure of ASDs in children to be effective. However, our initial experience is limited to short- and mid-term-follow-up of a low number of patients.
authors.affiliation: Department of Congenital Heart Defects and Pediatric Cardiology, Heart Center, University of Freiburg, Freiburg, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Grohmann
authors.forename: R
authors.initials: R
authors.lastname: Höhn
authors.forename: T
authors.initials: T
authors.lastname: Fleck
authors.forename: C
authors.initials: C
authors.lastname: Schmoor
authors.forename: B
authors.initials: B
authors.lastname: Stiller
mesh_terms: D000293:Adolescent; D000367:Age Factors; D000497:Alloys; D000768:Anesthesia, General; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D002648:Child; D002675:Child, Preschool; D017548:Echocardiography, Transesophageal; D005240:Feasibility Studies; D005260:Female; D005858:Germany; D006344:Heart Septal Defects, Atrial / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D006439:Hemodynamics; D006801:Humans; D057194:Intention to Treat Analysis; D008297:Male; D011138:Polytetrafluoroethylene; D011474:Prosthesis Design; D012189:Retrospective Studies; D055989:Septal Occluder Device; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000497:Alloys; C013616:nitinol; D011138:Polytetrafluoroethylene
keywords: catheter; congenital heart disease; device closure; occluder; pediatric; secundum type atrial septal defect