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Closure of Secundum Atrial Septal Defects by Using the Occlutech Occluder Devices in More Than 1300 Patients: The IRFACODE Project: A Retrospective Case Series
Author(s) -
Haas Nikolaus A.,
Soetemann Dagmar B.,
Ates Ismail,
Baspinar Osman,
Ditkivskyy Igor,
Duke Christopher,
Godart Francois,
Lorber Avraham,
Oliveira Edmundo,
Onorato Eustaquio,
Pac Feyza,
Promphan Worakan,
Riede FrankThomas,
Roymanee Supaporn,
Sabiniewicz Robert,
Shebani Suhair Omar,
Sievert Horst,
Tin Do,
Happel Christoph M.
Publication year - 2016
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.26497
Subject(s) - medicine , septum secundum , surgery , retrospective cohort study , aneurysm , closure (psychology) , economics , market economy
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.