title: Patent foramen ovale closure with the Gore septal occluder: initial UK experience.
abstract: OBJECTIVE
  To report procedural outcome and short-term follow-up data for the Gore septal occluder (GSO), a new device for closure of patent foramen ovale (PFO).
  
  
  BACKGROUND
  Transcatheter closure of PFO is an established treatment modality but no current device provides a perfect solution. The GSO has a number of design features, which make it potentially attractive for closure of defects in the atrial septum.
  
  
  METHODS
  Data from 9 centers in the United Kingdom implanting the GSO device, submitted to an electronic registry for evaluation.
  
  
  RESULTS
  Two hundred twenty-nine patients undergoing PFO closure from June 2011 to October 2012 were included. Indications for closure were secondary prevention of paradoxical cerebral emboli (83.4%), migraine (2.1%), platypnoea orthodeoxia (3.9%), and other (10.5%). Median PFO size was 8 mm and 34 and 39%, respectively, had long tunnel anatomy or atrial septal aneurysms. A GSO was successfully implanted in all cases. A single device was used in 98% but in 4 patients the initial device was removed and a second device required. Procedural complications occurred in 3% and later complications (e.g., atrial fibrillation, atrial ectopics, and device thrombus) in 5.7% of cases. All patients have undergone clinical and echocardiographic follow-up and all devices remain in position. Early bubble studies (median 0 months) with Valsalva maneuver in 67.2% were negative in 89%.
  
  
  CONCLUSIONS
  The GSO is an effective occlusion device for closure of PFO of all types. Longer-term follow-up particularly to document later closure rates are required.
authors.affiliation: Department of Congenital Cardiology, Leeds General Infirmary, Leeds, United Kingdom.
authors.forename: John D
authors.initials: JD
authors.lastname: Thomson
authors.forename: David
authors.initials: D
authors.lastname: Hildick-Smith
authors.forename: Paul
authors.initials: P
authors.lastname: Clift
authors.forename: Gareth
authors.initials: G
authors.lastname: Morgan
authors.forename: Matthew
authors.initials: M
authors.lastname: Daniels
authors.forename: Robert
authors.initials: R
authors.lastname: Henderson
authors.forename: Mark S
authors.initials: MS
authors.lastname: Spence
authors.forename: Vaikom S
authors.initials: VS
authors.lastname: Mahadevan
authors.forename: David
authors.initials: D
authors.lastname: Crossland
authors.forename: Oliver
authors.initials: O
authors.lastname: Ormerod
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D017548:Echocardiography, Transesophageal; D054092:Foramen Ovale, Patent / Q000150:complications / Q000000981:diagnostic imaging / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011474:Prosthesis Design; D012042:Registries; D012189:Retrospective Studies; D055989:Septal Occluder Device; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom; D055815:Young Adult
keywords: cerebrovascular accident; congenital heart; disease in adults; patent foramen ovale/atrial septal defect