Interventional ASD-closure with the Occlutech devices in 1333 patients - first results of the IRFACODE - registry

Introduction: Today, transcatheter ASD closure is a worldwide accepted treatment standard for suitable ASDs. The Occlutech ASD device series (OSO, Flex I, Flex II) show an improved device design and gained CE mark in 2007; however larger follow-up series are missing.

Methods: Retrospective analysis of the feasibility, safety, results and follow-up of ASD-closure with these devices over a 5 year period in 16 centers from 11 countries (IRFACODE registry).

Patients: In 1333 patients (female 67,4%) successful (96,2%) ASD closure was performed, mean age 29 years (range 4 months - 83 years), mean weight 51,8 kg (range 4 - 175 kg), mean length 148,5 cm (range 43 - 195 cm). 15,9% of the defects showed no and 33,2% only a deficient aortic rim (total 49,1%), in 12,8% there was more than one defect, a septum aneurysm in 19,4%. Implantation was performed with TTE only in 19,4%, with TOE guidance in 80,8% and with ICE in 6,9%, mean device size was 21 mm, the occluders used were OSO 41,1%, Flex I 40,8% and Flex II 17,2%.

Results: Immediate closure during implantation was achieved in 78,6%, at discharge 82,5%, at 6 and 12 months follow-up 95% and 95,8% respectively. The overall complication rate was only 6,3% (including 23 new onset arrhythmias, 19 new onset migraine, 2 TIA); significant complications (total = 7, < 0,5%) were device embolizations in 4 patients (3 without balloon sizing), 3 AV-blocks and no erosion or death.

Conclusions: Interventional closure of ASDs using the Occlutech ASD devices is feasible in a large variety of patients and seems safe with only a minimal risk of severe side effects and especially without aortic erosions despite a large percentage of defects with no or only deficient aortic rim.