Closure of Secundum Atrial Septal Defects by Using the Occlutech Occluder Devices in More Than 1300 Patients: The IRFACODE Project: A Retrospective Case Series
Corresponding Author
Nikolaus A. Haas MD, PhD
Department for Congenital Heart Defects, Heart and Diabetes Centre North Rhine Westphalia, Ruhr University Bochum, Germany
Department of Pediatric Cardiology and Intensive Care, Ludwig Maximilians University Munich Campus, Munich, Germany
DBS and NAH share the authorship in this publication.
Correspondence to: Nikolaus A. Haas, MD, PhD; Department of Pediatric Cardiology and Intensive Care, Ludwig Maximilians University (LMU) Munich, Campus Grosshadern, Marchioninistrasse 15, D-81377 Munich, Germany. E-mail: [email protected]Search for more papers by this authorDagmar B. Soetemann MD
Department for Congenital Heart Defects, Heart and Diabetes Centre North Rhine Westphalia, Ruhr University Bochum, Germany
DBS and NAH share the authorship in this publication.
Search for more papers by this authorIsmail Ates MD, PhD
Department of Cardiology, Asfendiyarov Kazakh National Medical University, Almaty, Kazakhistan
Search for more papers by this authorOsman Baspinar MD
Department of Pediatric Cardiology, Faculty of Medicine, University of Gaziantep, Turkey
Search for more papers by this authorChristopher Duke MD
King Faisal Cardiac Centre, Jeddah, Saudi Arabia
Search for more papers by this authorFrancois Godart MD, PhD
Département De Cardiologie Infantile Et Congénitale, Centre Hospitalier Régional Et Universitaire De Lille, Faculté De Médecine Lille 2, France
Search for more papers by this authorAvraham Lorber MD, PhD
Division of Pacing and Electrophysiology, Rambam Health Care Campus and Bruce Rappaport, Faculty of Medicine, Haifa, Israel
Search for more papers by this authorEdmundo Oliveira MD
Hospital Das Clinicas, Universida De Federal De Minas Gerais, Belo Horizonte, Minas Gerais, Brazil
Search for more papers by this authorEustaquio Onorato MD
Cardiovascular Department, Humanitas Gavazzeni Institute, Bergamo, Italy
Search for more papers by this authorFeyza Pac MD
Department of Pediatric Cardiology, Türkiye, Yüksekİhtisas, Training and Research Hospital, Ankara, Turkey
Search for more papers by this authorWorakan Promphan MD, PhD
Pediatric Cardiology Unit, Queen Sirikit National Institute of Child Health (QSNICH), Bangkok, Thailand
Search for more papers by this authorFrank-Thomas Riede MD
Department of Pediatric Cardiology, Heart Center, University of Leipzig, Leipzig, Germany
Search for more papers by this authorSupaporn Roymanee MD, PhD
Department of Pediatrics, Pediatric Cardiology Unit, Prince of Songkla University, Thailand
Search for more papers by this authorRobert Sabiniewicz MD, PhD
Department of Pediatric Cardiology and Congenital Heart Diseases, Medical University Gdansk, Poland
Search for more papers by this authorSuhair Omar Shebani MD
Glenfield Hospital Leicester, United Kingdom
Search for more papers by this authorHorst Sievert MD, PhD
Cardiovascular Centre Frankfurt, Frankfurt, Germany
Search for more papers by this authorDo Tin MD
Department of Cardiology, Children's Hospital and, Department of Pediatric, Medicine and Pharmacy University of Ho Chi Minh City, Vietnam
Search for more papers by this authorChristoph M. Happel MD, PhD
Department for Congenital Heart Defects, Heart and Diabetes Centre North Rhine Westphalia, Ruhr University Bochum, Germany
Search for more papers by this authorCorresponding Author
Nikolaus A. Haas MD, PhD
Department for Congenital Heart Defects, Heart and Diabetes Centre North Rhine Westphalia, Ruhr University Bochum, Germany
Department of Pediatric Cardiology and Intensive Care, Ludwig Maximilians University Munich Campus, Munich, Germany
DBS and NAH share the authorship in this publication.
Correspondence to: Nikolaus A. Haas, MD, PhD; Department of Pediatric Cardiology and Intensive Care, Ludwig Maximilians University (LMU) Munich, Campus Grosshadern, Marchioninistrasse 15, D-81377 Munich, Germany. E-mail: [email protected]Search for more papers by this authorDagmar B. Soetemann MD
Department for Congenital Heart Defects, Heart and Diabetes Centre North Rhine Westphalia, Ruhr University Bochum, Germany
DBS and NAH share the authorship in this publication.
Search for more papers by this authorIsmail Ates MD, PhD
Department of Cardiology, Asfendiyarov Kazakh National Medical University, Almaty, Kazakhistan
Search for more papers by this authorOsman Baspinar MD
Department of Pediatric Cardiology, Faculty of Medicine, University of Gaziantep, Turkey
Search for more papers by this authorChristopher Duke MD
King Faisal Cardiac Centre, Jeddah, Saudi Arabia
Search for more papers by this authorFrancois Godart MD, PhD
Département De Cardiologie Infantile Et Congénitale, Centre Hospitalier Régional Et Universitaire De Lille, Faculté De Médecine Lille 2, France
Search for more papers by this authorAvraham Lorber MD, PhD
Division of Pacing and Electrophysiology, Rambam Health Care Campus and Bruce Rappaport, Faculty of Medicine, Haifa, Israel
Search for more papers by this authorEdmundo Oliveira MD
Hospital Das Clinicas, Universida De Federal De Minas Gerais, Belo Horizonte, Minas Gerais, Brazil
Search for more papers by this authorEustaquio Onorato MD
Cardiovascular Department, Humanitas Gavazzeni Institute, Bergamo, Italy
Search for more papers by this authorFeyza Pac MD
Department of Pediatric Cardiology, Türkiye, Yüksekİhtisas, Training and Research Hospital, Ankara, Turkey
Search for more papers by this authorWorakan Promphan MD, PhD
Pediatric Cardiology Unit, Queen Sirikit National Institute of Child Health (QSNICH), Bangkok, Thailand
Search for more papers by this authorFrank-Thomas Riede MD
Department of Pediatric Cardiology, Heart Center, University of Leipzig, Leipzig, Germany
Search for more papers by this authorSupaporn Roymanee MD, PhD
Department of Pediatrics, Pediatric Cardiology Unit, Prince of Songkla University, Thailand
Search for more papers by this authorRobert Sabiniewicz MD, PhD
Department of Pediatric Cardiology and Congenital Heart Diseases, Medical University Gdansk, Poland
Search for more papers by this authorSuhair Omar Shebani MD
Glenfield Hospital Leicester, United Kingdom
Search for more papers by this authorHorst Sievert MD, PhD
Cardiovascular Centre Frankfurt, Frankfurt, Germany
Search for more papers by this authorDo Tin MD
Department of Cardiology, Children's Hospital and, Department of Pediatric, Medicine and Pharmacy University of Ho Chi Minh City, Vietnam
Search for more papers by this authorChristoph M. Happel MD, PhD
Department for Congenital Heart Defects, Heart and Diabetes Centre North Rhine Westphalia, Ruhr University Bochum, Germany
Search for more papers by this authorConflict of interest: NAH, AL, EO, and TD are proctors for ASD closure with the Occlutech devices. The other authors have no conflict of interest relevant for this article to declare.
Authors' statement: All authors take responsibility for all aspects of the reliability and freedom from bias of the data presented and their discussed interpretation.
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.
Conclusion
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.
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