title: Results of the U.S. Food and Drug Administration continued access clinical trial of the GORE HELEX septal occluder for secundum atrial septal defect.
abstract: OBJECTIVE
  This report describes the immediate, 1-, and 5-year follow-up results of the U.S. Food and Drug Administration Continued Access clinical trial of the GORE HELEX Septal Occluder (W. L. Gore & Associates, Inc., Flagstaff, Arizona) for closure of secundum atrial septal defect.
  
  
  BACKGROUND
  The trial was conducted between May 2003 and August 2006 to allow continued enrollment in a trial of the investigational device during review of data from the Pivotal Trial. Devices with hydrophilic coating on the expanded polytetrafluoroethylene to improve echocardiographic visualization were first used in this trial.
  
  
  METHODS
  A total of 137 devices were implanted in 137 patients at 13 US institutions. Evaluations were scheduled at 1, 6, and 12 months for the initial trial and at 36 and 60 months for a later extension of the trial in those who consented to longer term evaluations.
  
  
  RESULTS
  Twelve-month follow-up was completed on 122 of 126 patients with implantations, and 5-year follow-up on 83 of 95 patients who agreed to the trial extension. The overall clinical success rate was 96.7%, and the major adverse event rate 3.6%. Wire frame fractures were seen in 11.7% of patients with no clinical symptoms. A trivial, clinically insignificant leak was seen, or could not be ruled out, in 26.6% of patients at the 5-year evaluation, but no clinically significant leaks were seen. No patient experienced an erosion or sudden catastrophic event.
  
  
  CONCLUSIONS
  The immediate, 1-, and 5-year follow-up outcomes of the Continued Access clinical trial continue to demonstrate that the GORE HELEX Septal Occluder is a safe and effective transcatheter occluder for repair of ostium secundum atrial septal defect.
authors.affiliation: Advocate Children's Hospital, Oak Lawn, Illinois; University of Illinois Medical College, Chicago, Illinois. Electronic address: alexander.javois@advocatehealth.com.
authors.forename: Alexander J
authors.initials: AJ
authors.lastname: Javois
authors.affiliation: Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.
authors.forename: Jonathan J
authors.initials: JJ
authors.lastname: Rome
authors.affiliation: Seattle Children's Hospital, Seattle, Washington.
authors.forename: Thomas K
authors.initials: TK
authors.lastname: Jones
authors.affiliation: Heart Institute and Department of Pediatrics at Cedars-Sinai Medical Center, Los Angeles, California.
authors.forename: Evan M
authors.initials: EM
authors.lastname: Zahn
authors.affiliation: Arnold Palmer Hospital for Children, Orlando, Florida.
authors.forename: Craig E
authors.initials: CE
authors.lastname: Fleishman
authors.affiliation: Texas Children's Hospital, Houston, Texas.
authors.forename: Ricardo H
authors.initials: RH
authors.lastname: Pignatelli
authors.affiliation: Joe DiMaggio Children's Hospital, Hollywood, Florida.
authors.forename: Larry A
authors.initials: LA
authors.lastname: Latson
mesh_terms: D000293:Adolescent; D000328:Adult; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D002648:Child; D002675:Child, Preschool; D020099:Coated Materials, Biocompatible; D005260:Female; D006344:Heart Septal Defects, Atrial / Q000000981:diagnostic imaging / Q000628:therapy*; D006801:Humans; D007223:Infant; D008297:Male; D008875:Middle Aged; D011138:Polytetrafluoroethylene; D011474:Prosthesis Design; D055989:Septal Occluder Device; D013997:Time Factors; D016896:Treatment Outcome; D014463:Ultrasonography; D014481:United States; D014486:United States Food and Drug Administration; D055815:Young Adult
chemical_list: D020099:Coated Materials, Biocompatible; D011138:Polytetrafluoroethylene
keywords: ASD; HELEX; atrial septal defect