Pediatric Cardiology

, Volume 38, Issue 2, pp 215–227 | Cite as

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

  • 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-Feldmann
  • Oliver Kretschmar
  • Yulia Kuzmenko
  • Ornella Milanesi
  • Goetz Mueller
  • Giacomo Pongiglione
  • Stephan Schubert
  • Gleb Tarusinov
  • Christoph Kampmann
Original Article

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.

Keywords

Interventional VSD closure Perimembranous VSD Muscular VSD Congenital heart defects Nit-Occlud® Lê-VSD-Coil EUREVECO 

Abbreviations

VSD

Ventricular septum defect

Nit-Occlud® Lê-VSD-Coil

Coil used in this study

EUREVECO

European Registry for Ventricular Septal Defect Coil Occlusion

LA

Left atrium

LV

Left ventricle

PA

Pulmonary artery

RV

Right ventricle

ECHO

Echocardiography

ECG

Electrocardiogram

TTE

Transthoracic echocardiography

TOE

Transesophageal echocardiography

RBBB

Right bundle branch block

AVBlock III°

Third-degree complete atrioventricular block

Notes

Funding

The funding is by hospital funding only.

Compliance with ethical standards

Conflict of interest

There is no conflict of interest by any of the authors regarding this report.

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Copyright information

© Springer Science+Business Media New York 2016

Authors and Affiliations

  • Nikolaus A. Haas
    • 1
    • 10
  • Laura Kock
    • 1
  • Harald Bertram
    • 2
  • Regina Boekenkamp
    • 3
  • Daniel De Wolf
    • 4
  • Igor Ditkivskyy
    • 5
  • Matthias W. Freund
    • 6
  • Marc Gewillig
    • 7
  • Christoph M. Happel
    • 1
  • Ulrike Herberg
    • 8
  • Edvard Karthasyan
    • 9
  • Rainer Kozlik-Feldmann
    • 10
  • Oliver Kretschmar
    • 11
  • Yulia Kuzmenko
    • 12
  • Ornella Milanesi
    • 13
  • Goetz Mueller
    • 14
  • Giacomo Pongiglione
    • 15
  • Stephan Schubert
    • 16
  • Gleb Tarusinov
    • 17
  • Christoph Kampmann
    • 18
  1. 1.Department for Congenital Heart Defects, Heart and Diabetes Center North Rhine WestphaliaRuhr University BochumBad OeynhausenGermany
  2. 2.Department of Pediatric Cardiology and Pediatric Intensive CareChildren’s Hospital Hannover Medical SchoolHannoverGermany
  3. 3.Department for Pediatric CardiologyLeiden University Medical CenterLeidenNetherlands
  4. 4.Department for Pediatric CardiologyGhent University Hospital, UZ GhentGhentBelgium
  5. 5.Department of Interventional CardiologyNational Amosov Institute of Cardio-Vascular SurgeryKievUkraine
  6. 6.Department for Pediatric CardiologyUniversity Medical Center UtrechtUtrechtNetherlands
  7. 7.Department for Pediatric CardiologyUniversity Hospital LeuvenLouvainBelgium
  8. 8.Department for Pediatric CardiologyUniversity Hospital BonnBonnGermany
  9. 9.Center for Congenital Heart Defects and Pediatric CardiologyResearch Institution for Complex Issues of Cardiovascular DiseasesKemerovoRussia
  10. 10.Department of Pediatric Cardiology and Pediatric Intensive CareKlinikum der Ludwigs Maximilian Universität MünchenMunichGermany
  11. 11.Department for Pediatric Cardiology/Congenital Heart DefectsUniversity Children’s Hospital ZurichZurichSwitzerland
  12. 12.Department of Pediatric CardiologyThe Scientific Practical Children’s Cardiac CenterKievUkraine
  13. 13.Department of Women and Children’s Health Pediatric Cardiac UnitUniversity Hospital of PadovaPaduaItaly
  14. 14.Department for Pediatric CardiologyUniversity Heart Centre HamburgHamburgGermany
  15. 15.Department for Pediatric Cardiology and Pediatric Cardiac SurgeryBambino Gesú Children’s HospitalRome, VaticanItaly
  16. 16.Department for Congenital Heart Defects/Pediatric CardiologyDeutsches Herzzentrum BerlinBerlinGermany
  17. 17.Center for Congenital Heart Defects, Pediatric Cardiology, Heart Centre DuisburgEvangelic Hospital NiederrheinDuisburgGermany
  18. 18.Department for Pediatric CardiologyUniversity Children’s HospitalMainzGermany

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