Closure of ostium secundum atrial septum defect with the Atriasept occluder: Early European experience

Objectives : This multicentre study sought to report the safety and efficacy of the ATRIASEPT septal occluder to repair atrial septal defect (ASD). Background : The ATRIASEPT is a low profile, flexible, double disk occluder with centering system specifically designed for closure of ostium secundum ASD. Method : Patients were enrolled from four participating European sites and followed up for 12 months post procedure. Outcomes were evaluated, including closure success and incidence of adverse events. Results : Seventy‐six patients received the ATRIASEPT device. Mean size of the defect was 15 ± 4 mm. Closure success was observed in 69 patients (89%) at the end of the procedure. Sixty‐four patients had a six‐month follow up with a complete closure by 58 patients (90%). Minor adverse events occurred in two patients. Significant functional improvement was reported by all symptomatic patients. Conclusion : Percutaneous closure of ASD ostium secundum type defects with the ATRIASEPT is safe and effective with high success rate and excellent mid‐term outcome. © 2010 Wiley‐Liss, Inc.