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Updated: Aug 15, 2026
Closure of a Patent Foramen Ovale (PFO): An Intervention Sequence
Published on: December 23, 2022
Percutaneous closure of a patent foramen ovale: single-centre experience using different types of devices and
Martijn C Post1, Kristien Van Deyk, Werner Budts
1Department of Cardiology, St Antonius Hospital, Nieuwegein, The Netherlands.
Insights
Percutaneous patent foramen ovale (PFO) closure is a safe and effective treatment for cryptogenic stroke, with low recurrence rates regardless of the device used.
Area of Science:
- Cardiology
- Interventional Cardiology
- Neurology
Background:
- Patent foramen ovale (PFO) is linked to paradoxical embolism and cryptogenic stroke.
- Percutaneous PFO closure shows low recurrence rates for ischemic stroke.
Purpose of the Study:
- To report single-center experience with four different percutaneous PFO closure devices.
- To evaluate the efficacy and safety of PFO closure for cryptogenic stroke and other indications.
Main Methods:
- Retrospective study of 112 patients undergoing percutaneous PFO closure (1999-2003).
- Primary endpoint: recurrence of stroke, TIA, or peripheral thrombo-embolic event.
- Complications (periprocedural and mid-term) were recorded.
Main Results:
- 112 patients (mean age 52.1 years) included; 91.9% for cryptogenic stroke.
- Low event rates: 1.8% stroke, 2.8% TIA during 1.9 years median follow-up.
- Device types: Cardioseal/Starflex, Amplatzer PFO, PFO Star/CardiaStar, Helex.
- Complications included arrhythmias, device dislocation, thrombus formation, and allergic reactions.
- No significant differences in outcomes or complications between device types.
Conclusions:
- Percutaneous PFO closure is highly efficient and safe.
- Device type does not significantly impact outcomes or complication rates.
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.
