title: Closure of patent foramen ovale defects using GORE® CARDIOFORM septal occluder: Results from a prospective European multicenter study.
abstract: OBJECTIVE
  The GORE® CARDIOFORM Septal Occluder (GSO) is a novel device designed for rapid and effective closure of patent foramen ovale (PFO) which has distinctive features making it suitable for a broad spectrum of anatomical variations. We report the procedural and 6 months follow-up results of the first prospective, multicenter study using GSO.
  
  
  RESULTS
  This single-arm study included 150 subjects undergoing closure of PFO in 10 European centers. In 149 out of 150 patients implantation of a GSO device was successful. One patient had a different PFO-closure device implanted. Periprocedural complications were few including one patient with suspected transient ischemic attack, two access site bleedings, and one patient with AV-fistula. No device embolization occurred. During the 6-month follow-up period one patient had a transient asymptomatic thrombus on the device and four patients (2.6%) were diagnosed new onset paroxysmal atrial fibrillation, which were successfully treated. No thrombembolic events occurred. Closure was successful in 94.2% of subjects at discharge evaluation and 96.9% at 6 months follow-up.
  
  
  CONCLUSIONS
  This prospective, multicenter study adds to previous published data and suggests that GSO is a versatile device for PFO closure with high procedural and closure success rates and low complication rates through mid-term follow-up. © 2017 Wiley Periodicals, Inc.
authors.affiliation: Department of Cardiology, Angiology, and Pulmology, University of Heidelberg, Heidelberg, Germany.|Center for Cardiac and Circulatory Diseases, Bruchsal, Germany.
authors.forename: Stefan E
authors.identifier: http://orcid.org/0000-0001-6348-0388
authors.initials: SE
authors.lastname: Hardt
authors.affiliation: Department of Pediatric Cardiology and Congenital Heart Disease, Deutsches Herzzentrum München, Technische Universität, Munich, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Eicken
authors.affiliation: Klinik für Kinderkardiologie und angeborene Herzfehler, Deutsches Herzzentrum Berlin, Berlin, Germany.
authors.forename: Felix
authors.initials: F
authors.lastname: Berger
authors.affiliation: Klinik für Kinderkardiologie und angeborene Herzfehler, Deutsches Herzzentrum Berlin, Berlin, Germany.
authors.forename: Stephan
authors.initials: S
authors.lastname: Schubert
authors.affiliation: Department of Paediatric Cardiology and Cardiac Surgery and Adult Congenital Heart Disease, IRCCS Policlinico San Donato, Milan, 20097, Italy.
authors.forename: Mario
authors.initials: M
authors.lastname: Carminati
authors.affiliation: Department of Paediatric Cardiology and Cardiac Surgery and Adult Congenital Heart Disease, IRCCS Policlinico San Donato, Milan, 20097, Italy.
authors.forename: Gianfranco
authors.initials: G
authors.lastname: Butera
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: Rene
authors.initials: R
authors.lastname: Höhn
authors.affiliation: Department of Cardiology-Research, Institute of Clinical Medicine, Aarhus University Hospital Skejby, Aarhus N, DK-8200, Denmark.
authors.forename: Jens Erik
authors.initials: JE
authors.lastname: Nielsen-Kudsk
authors.affiliation: Department of Cardiology, Sussex Cardiac Centre, Brighton, United Kingdom.
authors.forename: David
authors.initials: D
authors.lastname: Hildick-Smith
authors.affiliation: Department of Cardiology, Karolinska University Hospital, Stockholm, Sweden.
authors.forename: Magnus
authors.initials: M
authors.lastname: Settergren
authors.affiliation: Department of Congenital Cardiology, Leeds General Infirmary, Leeds, United Kingdom.
authors.forename: John D
authors.initials: JD
authors.lastname: Thomson
authors.affiliation: Department of Cardiology, Angiology, and Pulmology, University of Heidelberg, Heidelberg, Germany.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Geis
authors.affiliation: The Heart Centre, Rigshospitalet University Hospital, Copenhagen, 2100, Denmark.
authors.forename: Lars
authors.initials: L
authors.lastname: Søndergaard
mesh_terms: D000328:Adult; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D005060:Europe; D005260:Female; D054092:Foramen Ovale, Patent / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000628:therapy*; D006439:Hemodynamics; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011474:Prosthesis Design; D055989:Septal Occluder Device; D013997:Time Factors; D016896:Treatment Outcome
keywords: ASD/PDA/PFO; closure; stroke; structural heart disease intervention