title: UK multicenter experience using the Gore septal occluder (GSO(TM) ) for atrial septal defect closure in children and adults.
abstract: BACKGROUND
  Percutaneous closure of atrial defects (ASD) has evolved as the treatment of choice for the majority of defects and patent oval foramens. The Gore Septal Occluder (GSO) is an innovative device consisting mostly of a folded thin GoreTex tube for use in the closure of septal defects.
  
  
  METHODS
  Reviewed is the multicenter UK experience of the first 22 ASD occlusions with the GSO(TM) device. All implantations were performed by consultant operators experienced in ASD device closure. The inclusion criterion was the presence of a hemodynamically significant secundum ASD with a diameter of <18 mm. Procedural data and acute and mid-term closure rates were retrospectively matched to a cohort of patients having defect closure using the Amplatzer Septal Occluder(TM) (ASO(TM) ).
  
  
  RESULTS
  Acute and 3-month follow-up closure rates for the GSO(TM) were 100% and 100% vs. 100% and 100% closure with the ASO(TM) implants. The difference in paired procedure times was not statistically significant (56 min: GSO(TM) ; 42 min: ASO(TM) device P = ns), nor was the paired difference in fluoroscopic screening times (12 min: GSO(TM) vs. 8.4 min: ASO(TM) , P = ns). One GSO device embolized immediately after deployment and was successfully retrieved at the same procedure. There were no other significant complications in either group.
  
  
  CONCLUSIONS
  The GSO(TM) implant can achieve comparable closure rates to the ASO(TM) in small to moderate atrial septal defects after 3 months. Longer fluoroscopy and procedure times are a drawback; however these should improve with familiarity with the implant and deployment system. The larger sheath size was not associated with increased complications in our cohort.
authors.affiliation: Yorkhill Hospital, Glasgow, United Kingdom.
authors.forename: Ben
authors.initials: B
authors.lastname: Smith
authors.forename: John
authors.initials: J
authors.lastname: Thomson
authors.forename: David
authors.initials: D
authors.lastname: Crossland
authors.forename: Mark S
authors.initials: MS
authors.lastname: Spence
authors.forename: Gareth J
authors.initials: GJ
authors.lastname: Morgan
mesh_terms: D000328:Adult; D000367:Age Factors; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D002648:Child; D002675:Child, Preschool; D005471:Fluoroscopy; D006344:Heart Septal Defects, Atrial / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D006439:Hemodynamics; D006801:Humans; D008875:Middle Aged; D011138:Polytetrafluoroethylene; D011474:Prosthesis Design; D015641:Radiography, Interventional; D012189:Retrospective Studies; D055989:Septal Occluder Device; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom
chemical_list: D011138:Polytetrafluoroethylene
keywords: atrial septal defect; congenital interventional cardiology; device occlusion