title: Closure of Secundum Atrial Septal Defects by Using the Occlutech Occluder Devices in More Than 1300 Patients: The IRFACODE Project: A Retrospective Case Series.
abstract: BACKGROUND
  The Occlutech Figulla ASD device series (OFSO) shows an improved device design for interventional ASD closure, larger follow-up series are missing.
  
  
  METHODS
  We retrospectively reviewed the feasibility, safety, implantation properties, results, and follow-up of ASD closure using Occlutech devices over a 5 year period by establishing a multi-institutional collaborative result registry with 16 contributing centers from 11 countries (IRFACODE).
  
  
  RESULTS
  In 1315 patients of all age groups (female 66.9%), successful (98%) ASD closure was performed (mean age 28.9 years, weight 52 kg, height 148.6 cm). Of the defects, 47.9% showed no or only a deficient aortic rim; in 11.9%, there was more than one defect; a septum aneurysm was present in 21.5%; and the mean implanted device size was 20.5 mm. Immediate closure was achieved in 78.6%, at discharge in 83.1%, and 96.4% and 97.3% at 6 and 12 months follow-up, respectively. During a mean follow-up of 2.7 years (in total 3597 patient years), significant complications were minimal (total = 8, <1%) with secondary device embolizations in five and AV-blocks in three patients. No erosion or death was reported.
  
  
  CONCLUSIONS
  ASD closure using OFSO is feasible in a large variety of patients, safe with only a minimal risk of severe side effects and especially without any aortic erosions despite a large percentage of large and complicated defects. © 2016 Wiley Periodicals, Inc.
authors.affiliation: Department for Congenital Heart Defects, Heart and Diabetes Centre North Rhine Westphalia, Ruhr University Bochum, Germany. Nikolaus.haas@med.uni-muenchen.de.|Department of Pediatric Cardiology and Intensive Care, Ludwig Maximilians University Munich Campus, Munich, Germany. Nikolaus.haas@med.uni-muenchen.de.
authors.forename: Nikolaus A
authors.initials: NA
authors.lastname: Haas
authors.affiliation: Department for Congenital Heart Defects, Heart and Diabetes Centre North Rhine Westphalia, Ruhr University Bochum, Germany.
authors.forename: Dagmar B
authors.initials: DB
authors.lastname: Soetemann
authors.affiliation: Department of Cardiology, Asfendiyarov Kazakh National Medical University, Almaty, Kazakhistan.
authors.forename: Ismail
authors.initials: I
authors.lastname: Ates
authors.affiliation: Department of Pediatric Cardiology, Faculty of Medicine, University of Gaziantep, Turkey.
authors.forename: Osman
authors.initials: O
authors.lastname: Baspinar
authors.affiliation: Amosov Institute, Kiew, Ukraine.
authors.forename: Igor
authors.initials: I
authors.lastname: Ditkivskyy
authors.affiliation: King Faisal Cardiac Centre, Jeddah, Saudi Arabia.
authors.forename: Christopher
authors.initials: C
authors.lastname: Duke
authors.affiliation: Département De Cardiologie Infantile Et Congénitale, Centre Hospitalier Régional Et Universitaire De Lille, Faculté De Médecine Lille 2, France.
authors.forename: Francois
authors.initials: F
authors.lastname: Godart
authors.affiliation: Division of Pacing and Electrophysiology, Rambam Health Care Campus and Bruce Rappaport, Faculty of Medicine, Haifa, Israel.
authors.forename: Avraham
authors.initials: A
authors.lastname: Lorber
authors.affiliation: Hospital Das Clinicas, Universida De Federal De Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.
authors.forename: Edmundo
authors.initials: E
authors.lastname: Oliveira
authors.affiliation: Cardiovascular Department, Humanitas Gavazzeni Institute, Bergamo, Italy.
authors.forename: Eustaquio
authors.initials: E
authors.lastname: Onorato
authors.affiliation: Department of Pediatric Cardiology, Türkiye, Yüksekİhtisas, Training and Research Hospital, Ankara, Turkey.
authors.forename: Feyza
authors.initials: F
authors.lastname: Pac
authors.affiliation: Pediatric Cardiology Unit, Queen Sirikit National Institute of Child Health (QSNICH), Bangkok, Thailand.
authors.forename: Worakan
authors.initials: W
authors.lastname: Promphan
authors.affiliation: Department of Pediatric Cardiology, Heart Center, University of Leipzig, Leipzig, Germany.
authors.forename: Frank-Thomas
authors.initials: FT
authors.lastname: Riede
authors.affiliation: Department of Pediatrics, Pediatric Cardiology Unit, Prince of Songkla University, Thailand.
authors.forename: Supaporn
authors.initials: S
authors.lastname: Roymanee
authors.affiliation: Department of Pediatric Cardiology and Congenital Heart Diseases, Medical University Gdansk, Poland.
authors.forename: Robert
authors.initials: R
authors.lastname: Sabiniewicz
authors.affiliation: Glenfield Hospital Leicester, United Kingdom.
authors.forename: Suhair Omar
authors.initials: SO
authors.lastname: Shebani
authors.affiliation: Cardiovascular Centre Frankfurt, Frankfurt, Germany.
authors.forename: Horst
authors.initials: H
authors.lastname: Sievert
authors.affiliation: Department of Cardiology, Children's Hospital and, Department of Pediatric, Medicine and Pharmacy University of Ho Chi Minh City, Vietnam.
authors.forename: Do
authors.initials: D
authors.lastname: Tin
authors.affiliation: Department for Congenital Heart Defects, Heart and Diabetes Centre North Rhine Westphalia, Ruhr University Bochum, Germany.
authors.forename: Christoph M
authors.initials: CM
authors.lastname: Happel
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001208:Asia; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D002648:Child; D002675:Child, Preschool; D005060:Europe; D005240:Feasibility Studies; D005260:Female; D006344:Heart Septal Defects, Atrial / Q000000981:diagnostic imaging / Q000628:therapy*; D006801:Humans; D007223:Infant; D057194:Intention to Treat Analysis; D008297:Male; D008875:Middle Aged; D011474:Prosthesis Design; D012042:Registries; D012189:Retrospective Studies; D012307:Risk Factors; D055989:Septal Occluder Device; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
keywords: ASD closure; Flex; Flex II; IRFACODE project; Occlutech device