1. Long-term outcome of perimembranous VSD closure using the Nit-Occlud® Lê VSD coil system.
- Author
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Kozlik-Feldmann R, Lorber A, Sievert H, Ewert P, Jux C, Müller GC, Dalla Pozza R, Yigitbasi M, Schranz D, Lindinger A, Galal O, and Meinertz T
- Subjects
- Adolescent, Adult, Aged, Child, Child, Preschool, Feasibility Studies, Female, Follow-Up Studies, Humans, Male, Middle Aged, Prosthesis Design, Retrospective Studies, Time Factors, Treatment Outcome, Young Adult, Cardiac Catheterization methods, Cardiac Surgical Procedures methods, Heart Septal Defects, Ventricular surgery, Septal Occluder Device
- 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.
- Published
- 2021
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