Interventional VSD-Closure with the Nit-Occlud® Lê VSD-Coil in 110 Patients: Early and Midterm Results of the EUREVECO-Registry
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Interventional VSD-Closure with the Nit-Occlud® Lê VSD-Coil in 110 Patients: Early and Midterm Results of the EUREVECO-Registry. / Haas, Nikolaus A; Kock, Laura; Bertram, Harald; Boekenkamp, Regina; De Wolf, Daniel; Ditkivskyy, Igor; Freund, Matthias W; Gewillig, Marc; Happel, Christoph M; Herberg, Ulrike; Karthasyan, Edvard; Kozlik-Feldmann, Rainer; Kretschmar, Oliver; Kuzmenko, Yulia; Milanesi, Ornella; Mueller, Goetz; Pongiglione, Giacomo; Schubert, Stephan; Tarusinov, Gleb; Kampmann, Christoph.
in: PEDIATR CARDIOL, Jahrgang 38, Nr. 2, 02.2017, S. 215-227.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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T1 - Interventional VSD-Closure with the Nit-Occlud® Lê VSD-Coil in 110 Patients: Early and Midterm Results of the EUREVECO-Registry
AU - Haas, Nikolaus A
AU - Kock, Laura
AU - Bertram, Harald
AU - Boekenkamp, Regina
AU - De Wolf, Daniel
AU - Ditkivskyy, Igor
AU - Freund, Matthias W
AU - Gewillig, Marc
AU - Happel, Christoph M
AU - Herberg, Ulrike
AU - Karthasyan, Edvard
AU - Kozlik-Feldmann, Rainer
AU - Kretschmar, Oliver
AU - Kuzmenko, Yulia
AU - Milanesi, Ornella
AU - Mueller, Goetz
AU - Pongiglione, Giacomo
AU - Schubert, Stephan
AU - Tarusinov, Gleb
AU - Kampmann, Christoph
PY - 2017/2
Y1 - 2017/2
N2 - 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.
AB - 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.
KW - Adolescent
KW - Cardiac Catheterization/methods
KW - Child
KW - Child, Preschool
KW - Europe
KW - Female
KW - Fluoroscopy
KW - Heart Septal Defects, Ventricular/classification
KW - Hemolysis
KW - Humans
KW - Infant
KW - Male
KW - Operative Time
KW - Registries
KW - Retrospective Studies
KW - Septal Occluder Device
KW - Treatment Outcome
U2 - 10.1007/s00246-016-1502-8
DO - 10.1007/s00246-016-1502-8
M3 - SCORING: Journal article
C2 - 27847970
VL - 38
SP - 215
EP - 227
JO - PEDIATR CARDIOL
JF - PEDIATR CARDIOL
SN - 0172-0643
IS - 2
ER -