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.