First experience with the 2005 modified Gore Helex ASD occluder system.

Area of Science:

• Cardiovascular Medicine
• Medical Devices
• Interventional Cardiology

Background:

• Atrial septal defects (ASD) and persistent foramen ovale (PFO) are common cardiac conditions.
• Transcatheter device closure has become a standard treatment for these defects.
• The Helex device, modified in 2005, aimed to simplify implantation for ASD and PFO closure.

Purpose of the Study:

• To evaluate the initial clinical experience with the modified Helex device for ASD and PFO closure.
• To assess the safety and efficacy of the Helex device in a pediatric and adult population.
• To report on implantation success rates, procedural times, and early occlusion outcomes.

Main Methods:

• Retrospective analysis of 11 patients (8 children, 3 adults) who underwent implantation of the modified Helex device.
• Patients were treated for relevant ASD with significant left-to-right shunts or PFO with a history of embolic events.
• Device implantation was performed percutaneously, with procedural success and early occlusion rates assessed.

Main Results:

• Successful implantation of the Helex occluder in all 11 patients.
• Mean fluoroscopy time was 8.4 minutes.
• Immediate occlusion rate after 24 hours was 91%, with excellent device adaptation to cardiac structures.

Conclusions:

• The modified Helex occluder is a reliable device for the transcatheter closure of small to moderate ASDs and PFOs.
• The simplified delivery system facilitates implantation.
• The procedure demonstrated a minimal risk of major complications in this initial series.