Interventional VSD-Closure with the Nit-Occlud® Lê VSD-Coil in 110 Patients: Early and Midterm Results of the EUREVECO-Registry

• DOI: 10.1007/s00246-016-1502-8
• Publication Date: 2016-11-15T07:44:05Z
• Authors: Nikolaus A. Haas; Laura Kock; Harald Bertram; Regina Boekenkamp; Daniel De Wolf; Igor Ditkivskyy; Matthias W. Freund; Marc Gewillig; Christoph M. Happel; Ulrike Herberg; Edvard Karthasyan; Rainer Kozlik-Fel...; Oliver Kretschmar; Yulia Kuzmenko; Ornella Milanesi; Goetz Mueller; Giacomo Pongiglione; Stephan Schubert; Gleb Tarusinov; Christoph Kampmann
• Keywords: Heart Septal Defects, Ventricular; Male; Cardiac Catheterization; Adolescent; Septal Occluder Device; Operative Time; 610 Medicine & health; Perimembranous VSD; Nit-Occlud (R); Hemolysis; 2705 Cardiology and Cardiovascular Medicine; Congenital heart defects; EUREVECO; Interventional VSD closure; Muscular VSD; Nit-Occlud® Lê-VSD-Coil; Perimembranous VSD; Pediatrics, Perinatology and Child Health; Cardiology and Cardiovascular Medicine; 03 medical and health sciences; Muscular VSD; 0302 clinical medicine; Humans; 2735 Pediatrics, Perinatology and Child Health; Registries; Child; Interventional VSD closure; Retrospective Studies; Infant; Le-VSD-Coil; 3. Good health; Europe; EUREVECO; Treatment Outcome; Congenital heart defects; 10036 Medical Clinic; Child, Preschool; Fluoroscopy; Female

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.