Dataset Information

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

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.

SUBMITTER: Kozlik-Feldmann R

PROVIDER: S-EPMC7906931 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Kozlik-Feldmann Rainer R Lorber Avraham A Sievert Horst H Ewert Peter P Jux Christian C Müller Götz C GC Dalla Pozza Robert R Yigitbasi Mustafa M Schranz Dietmar D Lindinger Angelika A Galal Omar O Meinertz Thomas T

Clinical research in cardiology : official journal of the German Cardiac Society 20201031 3

<h4>Objective</h4>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.<h4>Background</h4>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 ...[more]

PMID: 33128576

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