Aims: Patients with cryptogenic embolic events and a patent foramen ovale (PFO) are at risk of paradoxical embolism causing recurrent cerebral events; however, transcatheter PFO closure remains controversial. The aim of this multicentre trial was to demonstrate the feasibility and safety of transcatheter closure of PFO with the HELEX Septal Occluder.
Methods and results: The study enrolled 128 patients (66 female; mean age, 50 years). Mean (+/-SD) PFO size was 10+/-3.7 mm; 38 patients also had an atrial septal aneurysm. Device implantation was successful in 127 patients. Device-related events during implantation or follow-up were device embolisation, wire-frame fracture, and retrieval cord breaks (two cases each; no sequelae). Other adverse events included atrial arrhythmia (two patients), migraine, convulsion, and transient ischaemic attack (one case each). There were no recurrent strokes, deaths, perforations, or accumulations of thrombi on the device. Within a mean follow-up period of 21+/-11 months, complete PFO closure using one device was achieved in 114 patients (90%). Five patients with a moderate to large residual shunt received a second device.
Conclusion: The HELEX Occluder can be used for PFO closure. Device- and procedure-related complications are rare. The closure procedure appears to reduce recurrence rates of stroke and transient ischaemic attack.