Long-term outcome of perimembranous VSD closure using the Nit-Occlud® Lê VSD coil system

Rainer Kozlik-Feldmann, Avraham Lorber, Horst Sievert, Peter Ewert, Christian Jux, Götz C. Müller, Robert Dalla Pozza, Mustafa Yigitbasi, Dietmar Schranz, Angelika Lindinger, Omar Galal, Thomas Meinertz

Research output: Contribution to journalArticlepeer-review

11 Scopus citations

Abstract

Objective: This study presents data from the admission trial to show the feasibility, safety and effectiveness of the Nit-Occlud® Lê VSD in the treatment of perimembranous ventricular septal defects with an aneurysmal configuration and a diameter up to 8 mm. Background: The majority of ventricular septal defects (VSD) are still closed surgically, while a less invasive transcatheter treatment by closure devices is available. Device-based closure is reported to be associated with the risk of complete atrio-ventricular block, especially with double-disc devices in perimembranous defects. Methods: In six tertiary centers in Germany and Israel, an interventional closure of a periembranous VSD was attempted in 88 patients using the Nit-Occlud® Lê VSD. Results: The interventional VSD closure was performed in 85 patients. Patients had a median age of 8.0 (2–65) years and a median body weight of 26.7 (10–109) kg. A complete closure of the defects was achieved in 85.4% 2 weeks after device implantation, in 88.9% after three months and in 98.6% at the 5-year follow-up. There was no incidence of death during the study nor did any patient suffer of permanent atrio-ventricular block of higher degree. Serious adverse events, by definition, are potentially life-threatening or require surgery to correct, while major serious events require medical or transcatheter intervention to correct. The study results exhibit a serious adverse event rate of 3.5% (3/85 patients) and a major adverse event rate of 5.9% (5/85 patients). Conclusion: The Nit-Occlud® Lê VSD coil offers the possibility of an effective and safe approach in patients with aneurysmal perimembranous ventricular septal defects.

Original languageEnglish
Pages (from-to)382-390
Number of pages9
JournalClinical research in cardiology : official journal of the German Cardiac Society
Volume110
Issue number3
DOIs
StatePublished - Mar 2021

Keywords

  • Admission trial
  • Five-year follow-up
  • Interventional therapy
  • VSD coil system
  • Ventricular septal defect

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