Transcatheter Ventricular Septal Defect Closure with Nit-Occlud Lê VSD Device—Five Years’ Experience and Literature Review

Introduction: Transcatheter closure is an alternative to ventricular septal defect (VSD) occlusion surgery. Nit-Occlud Lê VSD coil is a new device yet to be evaluated. The study aimed to evaluate immediate and midterm results after transcatheter closure with the Nit-Occlud Lê VSD device. Methods: The retrospective analysis included 30 patients with VSD referred for closure during the period from October 2015 to December 2020. Results: At the time of intervention, the patients’ mean age and body weights were 7.5 ± 5.6 years and 29.3 ± 19.1 kg. The majority of the defects had perimembranous location (24/30), four defects had muscular and two outlet subaortic position. The mean effective right-side diameter of the VSDs was 3.6 ± 1.3 mm. Single ventricular fibrillation, device embolization, and hemolysis developed in different patients and were successfully treated. None of the patients had a complete atrioventricular block. The coil was successfully placed in 25/30 (83.3%) patients. The majority of the devices were 10 mm × 6 mm (11/25) and 12 mm × 8 mm (8/25) in size. Two patients required the implantation of a second device. The follow-up period was 2.1 ± 1.4 years. Complete VSD closure was achieved in 48% of cases immediately after the intervention, 74% during 2.1 ± 1.6 months after the procedure, and 81% over follow-up. The remaining patients had a trivial residual defect. During the follow-up, approximately one-third of patients developed trivial aortic and mitral valve regurgitation, and half of the patients acquired trace/mild tricuspid regurgitation. Standardized (z-score) left ventricular end-diastolic diameter (0.15 ± 0.37 vs. 0.92 ± 0.82, p = 0.005) and left atrium dimension (0.47 ± 0.58 vs. 1.89 ± 1.11, p = 0.005), as well as the left atrium to aortic root ratio (1.2 ± 0.1 vs. 1.4 ± 0.2, p = 0.005) showed a significant decrease over follow-up related to the period before intervention. Conclusion: Intervention with Nit-Occlud® Lê VSD coil showed appropriate results regarding VSD closure rate, complications, and chamber remodeling. The introduction of this device into clinical practice is a significant step forward in transcatheter perimembranous VSD occlusion.