Percutaneous closure of a patent foramen ovale: single-centre experience using different types of devices and mid-term outcome

Abstract

Introduction: Patent foramen ovale (PFO) has been identified as a source of paradoxical embolism and cryptogenic stroke. Low recurrence rates of ischaemic stroke after percutaneous closure have been described. We report our single-centre experience using four different types of devices.

Methods: All patients, who underwent a percutaneous PFO closure in the University Hospitals Leuven between February 1999 and December 2003, were included. The primary end point was defined as reoccurrence of stroke, transient ischaemic attack (TIA), or a peripheral thrombo-embolic event. The periprocedural and mid-term complications were reported.

Results: One-hundred and twelve patients, mean age 52.1 +/- 12.5 years (63 men/49 women), were included in the study. Indications for closure were cryptogenic stroke (91.9%), peripheral embolism (4.5%), obligate right-to-left shunt in Ebstein anomaly (1.8%), platypnoea syndrome or brain abscesses (both 0.9%). The Cardioseal/Starflex was used in 12, the Amplatzer PFO occluder in 35, the PFO Star/CardiaStar in 64, and the Helex in one patient. The primary end point occurred in 1.8% for stroke and 2.8% for TIA during a median follow-up of 1.9 years, range 4.9 years. Periprocedural complications were dislocation of the device (0.9%), transient arrhythmias (15.5%), aspiration pneumonia (0.9%), inguinal haematoma (3.6%), and an allergic reaction to medication (1.8%). Mid-term complications were perforation of the device (0.9%), persistent transient arrhythmias (6.3%) and thrombus formation on the device (0.9%). No significant differences in outcome or the occurrence of any type of complication could be documented between the different types of devices.

Conclusion: Percutaneous PFO closure seems to be a highly efficient and relatively safe procedure, independent of the type of device used for closure.