Long-term outcome of perimembranous VSD closure using the Nit-Occlud (R) Le VSD coil system

Kozlik-Feldmann, Rainer; Lorber, Avraham; Sievert, Horst; Ewert, Peter; Jux, Christian; Müller, Gotz C.; Dalla Pozza, Robert; Yigitbasi, Mustafa; Schranz, Dietmar; Lindinger, Angelika; Galal, Omar und Meinertz, Thomas (2020): Long-term outcome of perimembranous VSD closure using the Nit-Occlud (R) Le VSD coil system. In: Clinical Research in Cardiology, Bd. 110, Nr. 3: S. 382-390

Abstract

Objective: This study presents data from the admission trial to show the feasibility, safety and effectiveness of the Nit-Occlud (R) Le 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 (R) Le 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 (R) Le VSD coil offers the possibility of an effective and safe approach in patients with aneurysmal perimembranous ventricular septal defects.

• Dokumententyp: Zeitschriftenartikel
• Fakultät: Medizin
• Themengebiete: 600 Technik, Medizin, angewandte Wissenschaften > 610 Medizin und Gesundheit
• ISSN: 1861-0684
• Sprache: Englisch