Nikolaus A Haas1,2, Dagmar B Soetemann3, Ismail Ates4, Osman Baspinar5, Igor Ditkivskyy6, Christopher Duke7, Francois Godart8, Avraham Lorber9, Edmundo Oliveira10, Eustaquio Onorato11, Feyza Pac12, Worakan Promphan13, Frank-Thomas Riede14, Supaporn Roymanee15, Robert Sabiniewicz16, Suhair Omar Shebani17, Horst Sievert18, Do Tin19, Christoph M Happel3. 1. Department for Congenital Heart Defects, Heart and Diabetes Centre North Rhine Westphalia, Ruhr University Bochum, Germany. Nikolaus.haas@med.uni-muenchen.de. 2. Department of Pediatric Cardiology and Intensive Care, Ludwig Maximilians University Munich Campus, Munich, Germany. Nikolaus.haas@med.uni-muenchen.de. 3. Department for Congenital Heart Defects, Heart and Diabetes Centre North Rhine Westphalia, Ruhr University Bochum, Germany. 4. Department of Cardiology, Asfendiyarov Kazakh National Medical University, Almaty, Kazakhistan. 5. Department of Pediatric Cardiology, Faculty of Medicine, University of Gaziantep, Turkey. 6. Amosov Institute, Kiew, Ukraine. 7. King Faisal Cardiac Centre, Jeddah, Saudi Arabia. 8. Département De Cardiologie Infantile Et Congénitale, Centre Hospitalier Régional Et Universitaire De Lille, Faculté De Médecine Lille 2, France. 9. Division of Pacing and Electrophysiology, Rambam Health Care Campus and Bruce Rappaport, Faculty of Medicine, Haifa, Israel. 10. Hospital Das Clinicas, Universida De Federal De Minas Gerais, Belo Horizonte, Minas Gerais, Brazil. 11. Cardiovascular Department, Humanitas Gavazzeni Institute, Bergamo, Italy. 12. Department of Pediatric Cardiology, Türkiye, Yüksekİhtisas, Training and Research Hospital, Ankara, Turkey. 13. Pediatric Cardiology Unit, Queen Sirikit National Institute of Child Health (QSNICH), Bangkok, Thailand. 14. Department of Pediatric Cardiology, Heart Center, University of Leipzig, Leipzig, Germany. 15. Department of Pediatrics, Pediatric Cardiology Unit, Prince of Songkla University, Thailand. 16. Department of Pediatric Cardiology and Congenital Heart Diseases, Medical University Gdansk, Poland. 17. Glenfield Hospital Leicester, United Kingdom. 18. Cardiovascular Centre Frankfurt, Frankfurt, Germany. 19. Department of Cardiology, Children's Hospital and, Department of Pediatric, Medicine and Pharmacy University of Ho Chi Minh City, Vietnam.
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.
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.
Authors: Isabelle Boon; Katrien Vertongen; Bernard P Paelinck; Laurent Demulier; An Van Berendoncks; Catherine De Maeyer; Fabienne Marchau; Joseph Panzer; Kristof Vandekerckhove; Daniel De Wolf Journal: Pediatr Cardiol Date: 2017-09-27 Impact factor: 1.655
Authors: Roel J R Snijder; Laura E Renes; Martin J Swaans; Maarten Jan Suttorp; Jurrien M Ten Berg; Martijn C Post Journal: J Interv Cardiol Date: 2020-09-07 Impact factor: 2.279