title: Interventional VSD-Closure with the Nit-Occlud®Lê VSD-Coil in 110 Patients: Early and Midterm Results of the EUREVECO-Registry.
abstract: In August 2010, the Nit-Occlud®Lê (EUREVECO) became available for transcatheter coil occlusion of ventricular septal defects (VSDs). Retrospective European Registry for VSD Closure using the Nit-Occlud®Lê-VSD-Coil; analysis of the feasibility, results, safety and follow-up of VSD-closure over a 3-year period in 18 European centers. In 102 of 111 patients (female 66), successful VSD closure was performed (mean age 8.2 years, mean weight 28.82 kg), 81 perimembranous VSDs (48 with aneurysm), 30 muscular VSDs, mean procedure time was 121.1 min, and mean fluoroscopy time was 26.3 min. Short- and midterm term follow-up was possible in 100/102 patients, there was 1 embolization and 1 explantation after 24 months. Immediate complete closure occurred in 49 of 101 patients (48.5%), trivial residual shunt was present in 51 (50.0%), closure rate was 95% after 6 months and 97% after 1 year. Out of the 102 patients, there were 2 severe complications (1.8%) (1 severe hemolysis, 1 embolization) and 8 moderate/transient (=7.2%) including 1 transient AV block. During a mean follow-up period of 31.3 months (range 24-48) and a total follow-up time of 224.75 patient years, no further problems occurred. VSD closure with the Nit-Occlud®Lê VSD coil is feasible and safe with a minimal risk of severe side effects. The long-term effects and safety require further clinical follow-up studies.
authors.affiliation: Department for Congenital Heart Defects, Heart and Diabetes Center North Rhine Westphalia, Ruhr University Bochum, Georgstrasse 11, 32545, Bad Oeynhausen, Germany. NikolausHaas@med.uni-muenchen.de.|Department of Pediatric Cardiology and Pediatric Intensive Care, Klinikum der Ludwigs Maximilian Universität München, Munich, Germany. NikolausHaas@med.uni-muenchen.de.
authors.forename: Nikolaus A
authors.initials: NA
authors.lastname: Haas
authors.affiliation: Department for Congenital Heart Defects, Heart and Diabetes Center North Rhine Westphalia, Ruhr University Bochum, Georgstrasse 11, 32545, Bad Oeynhausen, Germany.
authors.forename: Laura
authors.initials: L
authors.lastname: Kock
authors.affiliation: Department of Pediatric Cardiology and Pediatric Intensive Care, Children's Hospital Hannover Medical School, Hannover, Germany.
authors.forename: Harald
authors.initials: H
authors.lastname: Bertram
authors.affiliation: Department for Pediatric Cardiology, Leiden University Medical Center, Leiden, Netherlands.
authors.forename: Regina
authors.initials: R
authors.lastname: Boekenkamp
authors.affiliation: Department for Pediatric Cardiology, Ghent University Hospital, UZ Ghent, Ghent, Belgium.
authors.forename: Daniel
authors.initials: D
authors.lastname: De Wolf
authors.affiliation: Department of Interventional Cardiology, National Amosov Institute of Cardio-Vascular Surgery, Kiev, Ukraine.
authors.forename: Igor
authors.initials: I
authors.lastname: Ditkivskyy
authors.affiliation: Department for Pediatric Cardiology, University Medical Center Utrecht, Utrecht, Netherlands.
authors.forename: Matthias W
authors.initials: MW
authors.lastname: Freund
authors.affiliation: Department for Pediatric Cardiology, University Hospital Leuven, Louvain, Belgium.
authors.forename: Marc
authors.initials: M
authors.lastname: Gewillig
authors.affiliation: Department for Congenital Heart Defects, Heart and Diabetes Center North Rhine Westphalia, Ruhr University Bochum, Georgstrasse 11, 32545, Bad Oeynhausen, Germany.
authors.forename: Christoph M
authors.initials: CM
authors.lastname: Happel
authors.affiliation: Department for Pediatric Cardiology, University Hospital Bonn, Bonn, Germany.
authors.forename: Ulrike
authors.initials: U
authors.lastname: Herberg
authors.affiliation: Center for Congenital Heart Defects and Pediatric Cardiology, Research Institution for Complex Issues of Cardiovascular Diseases, Kemerovo, Russia.
authors.forename: Edvard
authors.initials: E
authors.lastname: Karthasyan
authors.affiliation: Department of Pediatric Cardiology and Pediatric Intensive Care, Klinikum der Ludwigs Maximilian Universität München, Munich, Germany.
authors.forename: Rainer
authors.initials: R
authors.lastname: Kozlik-Feldmann
authors.affiliation: Department for Pediatric Cardiology/Congenital Heart Defects, University Children's Hospital Zurich, Zurich, Switzerland.
authors.forename: Oliver
authors.initials: O
authors.lastname: Kretschmar
authors.affiliation: Department of Pediatric Cardiology, The Scientific Practical Children's Cardiac Center, Kiev, Ukraine.
authors.forename: Yulia
authors.initials: Y
authors.lastname: Kuzmenko
authors.affiliation: Department of Women and Children's Health Pediatric Cardiac Unit, University Hospital of Padova, Padua, Italy.
authors.forename: Ornella
authors.initials: O
authors.lastname: Milanesi
authors.affiliation: Department for Pediatric Cardiology, University Heart Centre Hamburg, Hamburg, Germany.
authors.forename: Goetz
authors.initials: G
authors.lastname: Mueller
authors.affiliation: Department for Pediatric Cardiology and Pediatric Cardiac Surgery, Bambino Gesú Children's Hospital, Rome, Vatican, Italy.
authors.forename: Giacomo
authors.initials: G
authors.lastname: Pongiglione
authors.affiliation: Department for Congenital Heart Defects/Pediatric Cardiology, Deutsches Herzzentrum Berlin, Berlin, Germany.
authors.forename: Stephan
authors.initials: S
authors.lastname: Schubert
authors.affiliation: Center for Congenital Heart Defects, Pediatric Cardiology, Heart Centre Duisburg, Evangelic Hospital Niederrhein, Duisburg, Germany.
authors.forename: Gleb
authors.initials: G
authors.lastname: Tarusinov
authors.affiliation: Department for Pediatric Cardiology, University Children's Hospital, Mainz, Germany.
authors.forename: Christoph
authors.initials: C
authors.lastname: Kampmann
mesh_terms: D000293:Adolescent; D006328:Cardiac Catheterization / Q000379:methods*; D002648:Child; D002675:Child, Preschool; D005060:Europe; D005260:Female; D005471:Fluoroscopy; D006345:Heart Septal Defects, Ventricular / Q000145:classification / Q000628:therapy*; D006461:Hemolysis; D006801:Humans; D007223:Infant; D008297:Male; D061646:Operative Time; D012042:Registries; D012189:Retrospective Studies; D055989:Septal Occluder Device; D016896:Treatment Outcome
keywords: Congenital heart defects; EUREVECO; Interventional VSD closure; Muscular VSD; Nit-Occlud® Lê-VSD-Coil; Perimembranous VSD