Interventional VSD-Closure with the Nit-Occlud® Lê VSD-Coil in 110 Patients: Early and Midterm Results of the EUREVECO-Registry

Abstract

In August 2010, the Nit-Occlud Lê (EUREVECO) became available for transcatheter coil occlusion of ventricular septal defects (VSDs). Retrospective European Registry for VSD Closure using the Nit-Occlud Lê-VSD-Coil; analysis of the feasibility, results, safety and follow-up of VSD-closure over a 3-year period in 18 European centers. In 102 of 111 patients (female 66), successful VSD closure was performed (mean age 8.2 years, mean weight 28.82 kg), 81 perimembranous VSDs (48 with aneurysm), 30 muscular VSDs, mean procedure time was 121.1 min, and mean fluoroscopy time was 26.3 min. Short- and midterm term follow-up was possible in 100/102 patients, there was 1 embolization and 1 explantation after 24 months. Immediate complete closure occurred in 49 of 101 patients (48.5%), trivial residual shunt was present in 51 (50.0%), closure rate was 95% after 6 months and 97% after 1 year. Out of the 102 patients, there were 2 severe complications (1.8%) (1 severe hemolysis, 1 embolization) and 8 moderate/transient (=7.2%) including 1 transient AV block. During a mean follow-up period of 31.3 months (range 24-48) and a total follow-up time of 224.75 patient years, no further problems occurred. VSD closure with the Nit-Occlud Lê VSD coil is feasible and safe with a minimal risk of severe side effects. The long-term effects and safety require further clinical follow-up studies.

Nit-Occlud Lê VSD coil versus Duct Occluders for percutaneous perimembranous ventricular septal defect closure

“…In this study, the procedure success rate was high in both groups (95.6% in the DO group vs. 97.2%in the Coil group, P 5 .53) and comparable to other studies using conventional, off-label use or new devices for percutaneous pmVSD closure. [8][9][10][11][12][13][14][26][27][28][29] In contrast, the clo- [30][31][32][33] Thus, percutaneous VSD closure has been largely abandoned in many countries, and surgical closure is still accepted as the standard therapy for pmVSD. Patients in whom CHB was first detected after percutaneous VSD closure in our centers were treated with intense medication, including corticosteroids, temporary pacemaker and continuously followed for two weeks.…”

“…The conventional pmVSD Occluders have a high tendency to cause damage to the ventricular septum and other adjacent structures because of their big delivery system needed for the large profile devices, high clamping force caused by double disc design and high radial stress due to high device stiffness . Other devices with a low profile and ease of implantation may reduce the trauma, clamp force and radial stress to the ventricular septum and thereby decrease the CHB complication rate . Among available devices, Nit‐Occlud Lê VSD Coil and Duct Occluders have these characteristics and offer a promising alternative to conventional VSD occluders with a better outcome.…”

“…8 Other devices with a low profile and ease of implantation may reduce the trauma, clamp force and radial stress to the ventricular septum and thereby decrease the CHB complication rate. 8,9 Among available devices, Nit-Occlud Lê VSD Coil and Duct Occluders have these characteristics and offer a promising alternative to conventional VSD occluders with a better outcome. This study was approved by the Institutional Review Board of Quang Nam Central General Hospital and was conducted in accordance with the Declaration of Helsinki.…”

Ендоваскулярне Закриття Дефектів Міжшлуночкової Перегородки

“…Для закриття ДМШП використовувались такі пристрої: MemoPart VSD muscular occluder, MemoPart VSD perimembranous occluder, MemoPart ASD occluder (SHSMA, Shanghai shape memory alloy); muscular VSD occluders, tapered PDA occluder (Lepu medical technology, Beijing, Co., Ltd); Nit-occlud le VSD coil, Nit-occlud PDA coil (PFM medical, Cologne, Germany); KONAR-MF multifunctional occluder, Cera VSD occluder (Lifetech Scientific, Shenzhen, Co., Ltd.). Детальний опис усіх пристроїв є в іноземних публікаціях [12][13][14][15][16][17].…”

Inn i fremtiden med 3D og hologram

“…De siste årene er det blitt utviklet nytt, mer skånsomt utstyr. Tallene publisert fra et europeisk register (EUREVECO) viste ingen permanente tilfeller av komplett AV-blokk blant 81 pasienter med median oppfølgingstid på 31 måneder (1). Kanskje kan dette bli morgendagens behandling av denne vanlige hjertefeilen?…”