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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

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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.

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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

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Funding

The funding is by hospital funding only.

Author information

Authors and Affiliations

  1. Department for Congenital Heart Defects, Heart and Diabetes Center North Rhine Westphalia, Ruhr University Bochum, Georgstrasse 11, 32545, Bad Oeynhausen, Germany

    Nikolaus A. Haas, Laura Kock & Christoph M. Happel

  2. Department of Pediatric Cardiology and Pediatric Intensive Care, Children’s Hospital Hannover Medical School, Hannover, Germany

    Harald Bertram

  3. Department for Pediatric Cardiology, Leiden University Medical Center, Leiden, Netherlands

    Regina Boekenkamp

  4. Department for Pediatric Cardiology, Ghent University Hospital, UZ Ghent, Ghent, Belgium

    Daniel De Wolf

  5. Department of Interventional Cardiology, National Amosov Institute of Cardio-Vascular Surgery, Kiev, Ukraine

    Igor Ditkivskyy

  6. Department for Pediatric Cardiology, University Medical Center Utrecht, Utrecht, Netherlands

    Matthias W. Freund

  7. Department for Pediatric Cardiology, University Hospital Leuven, Louvain, Belgium

    Marc Gewillig

  8. Department for Pediatric Cardiology, University Hospital Bonn, Bonn, Germany

    Ulrike Herberg

  9. Center for Congenital Heart Defects and Pediatric Cardiology, Research Institution for Complex Issues of Cardiovascular Diseases, Kemerovo, Russia

    Edvard Karthasyan

  10. Department of Pediatric Cardiology and Pediatric Intensive Care, Klinikum der Ludwigs Maximilian Universität München, Munich, Germany

    Nikolaus A. Haas & Rainer Kozlik-Feldmann

  11. Department for Pediatric Cardiology/Congenital Heart Defects, University Children’s Hospital Zurich, Zurich, Switzerland

    Oliver Kretschmar

  12. Department of Pediatric Cardiology, The Scientific Practical Children’s Cardiac Center, Kiev, Ukraine

    Yulia Kuzmenko

  13. Department of Women and Children’s Health Pediatric Cardiac Unit, University Hospital of Padova, Padua, Italy

    Ornella Milanesi

  14. Department for Pediatric Cardiology, University Heart Centre Hamburg, Hamburg, Germany

    Goetz Mueller

  15. Department for Pediatric Cardiology and Pediatric Cardiac Surgery, Bambino Gesú Children’s Hospital, Rome, Vatican, Italy

    Giacomo Pongiglione

  16. Department for Congenital Heart Defects/Pediatric Cardiology, Deutsches Herzzentrum Berlin, Berlin, Germany

    Stephan Schubert

  17. Center for Congenital Heart Defects, Pediatric Cardiology, Heart Centre Duisburg, Evangelic Hospital Niederrhein, Duisburg, Germany

    Gleb Tarusinov

  18. Department for Pediatric Cardiology, University Children’s Hospital, Mainz, Germany

    Christoph Kampmann

Authors
  1. Nikolaus A. Haas
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  2. Laura Kock
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  3. Harald Bertram
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  4. Regina Boekenkamp
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  5. Daniel De Wolf
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  6. Igor Ditkivskyy
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  7. Matthias W. Freund
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  8. Marc Gewillig
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  9. Christoph M. Happel
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  10. Ulrike Herberg
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  13. Oliver Kretschmar
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  14. Yulia Kuzmenko
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  15. Ornella Milanesi
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  16. Goetz Mueller
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  17. Giacomo Pongiglione
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  18. Stephan Schubert
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  19. Gleb Tarusinov
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  20. Christoph Kampmann
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Corresponding author

Correspondence to Nikolaus A. Haas.

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

Additional information

Nikolaus A. Haas and Laura Kock have equally shared the authorship in this publication.

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Haas, N.A., Kock, L., Bertram, H. et al. Interventional VSD-Closure with the Nit-Occlud® Lê VSD-Coil in 110 Patients: Early and Midterm Results of the EUREVECO-Registry. Pediatr Cardiol 38, 215–227 (2017). https://doi.org/10.1007/s00246-016-1502-8

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  • DOI: https://doi.org/10.1007/s00246-016-1502-8

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