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.
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.