Helex septal occluder: feasibility study of closure of atrial septal defect.

BACKGROUND

A variety of transcatheter atrial septal defect (ASD) occluders are currently in use, the most commonly used device is the Amplatzer Septal Occluder (ASO) yet there is no perfect device. The Helex Septal Occluder is a new device (by W.L. Gore & Associates, Inc.) designed to improve the results of transcatheter ASD closure. We report our first experience in closing secundum ASDs with this new device after its recent modifications.

METHODS

Thirteen patients were selected for Helex device closure with median age of 8 years (2.5-44 years) and median weight 30 Kg (12-96 Kg). Inclusion criteria were: small to moderate Secundum ASDs with sufficient rims by transthoracic echo (TTE) and confirmed by transoesophageal echo (TEE). Two cardiologists carried out the decision of device size. One of the five available Helex ASD device sizes was used (15-35 mm). Follow up TTE was performed the next day, one month, six months and one year later.

RESULTS

Twelve patients had successful Helex septal occluder implantation. One patient was switched to Cribriform ASD device during the procedure because of failure of the locking mechanism. Two patients had trivial residual left to right shunt which disappeared at one month follow up in one patient. No embolic event, AV block or mortality was observed.

CONCLUSION

This feasibility study of the novel Helex septal occluder after its recent modification showed that it can successfully and safely close well selected secundum ASDs. There are several advantages over the currently available devices.