Long Term Single Centre experience with the Helex Septal Occluder
Introduction
The Helex(TM) Septal Occluder is a purposed designed device for transcatheter atrial septal defect (ASD) closure. We report our institutions experience with this device.
Methods
All patients who underwent implantation of a Helex(TM) Septal Occluder were reviewed. Procedures were performed using general anaesthesia with transoesophageal echocardiography guidance. Procedural success was defined as accurate placement of a device. Clinical review with transthoracic echocardiography was performed at 24hrs, 1mth, 6mths and 1yr following deployment and fluoroscopic screening was performed at 6mths.
Results
49 patients underwent device implantation between May 2001 and Dec 2008. Two patients had device closure of Fontan fenestrations, two had closure of patent foramen ovale and the remaining 45 procedures were for secundum ASD closure. The average ASD size was 11.9mm (range 5-22mm). Age range at implantation was 1-18 yrs with a weight range of 9.6-76.8 kg and the median follow up was 2.05 years (1mth – 7.58 years). In 15 patients a residual leak was noted immediately post-procedure with only 1 patient having a residual haemodynamically significant shunt at 1 year due to device malposition. There were two device embolization’s and both were retrieved percutaneously. There has been 1 device frame fracture identified. Five patients experienced migrainous headaches post-procedure which in 2 patients persisted beyond 6 months. No patients developed any pathological rhythm disturbances or complaints of palpitations.
Conclusions
The Helex(TM) device has proven to be an effective device with the added benefit of easy retrievability. The occurrence of frame fracture has not been of clinical concern.