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Updated: Jul 19, 2026

Closure of a Patent Foramen Ovale (PFO): An Intervention Sequence
Published on: December 23, 2022
Transcatheter closure versus medical therapy of patent foramen ovale and cryptogenic stroke
Basil Vasilios D Thanopoulos1, Petros D Dardas, Evangelos Karanasios
1Department of Cardiology, Aghia Sophia Children's Hospital, Athens, Greece. vthanop@otenet.gr
Insights
Device closure of patent foramen ovale (PFO) is a safe and effective alternative to antiplatelet therapy for preventing recurrent cryptogenic stroke (CS). PFO closure significantly reduced embolic events compared to antiplatelet therapy.
Area of Science:
- Cardiology
- Neurology
- Medical Devices
Background:
- No controlled data exist comparing device closure of patent foramen ovale (PFO) with medical treatment for cryptogenic stroke (CS).
- Evaluating PFO closure efficacy and safety is crucial for managing CS patients.
Purpose of the Study:
- To compare the efficacy and safety of PFO device closure versus antiplatelet therapy in patients with CS.
- To assess the recurrence rate of stroke in patients with PFO and CS undergoing different treatments.
Main Methods:
- A nonrandomized, prospective case series of 92 patients with PFO and CS.
- Patients were treated with either antiplatelet agents (44) or PFO catheter closure using the Amplatzer PFO occluder (APFOO) (48).
- A 2-year follow-up was completed for all patients.
Main Results:
- PFO closure achieved 91% immediate complete closure, with no complications.
- The PFO closure group had 0% incidence of embolic events/year, versus 14.75% in the antiplatelet therapy group (P < 0.001).
- The antiplatelet group experienced 3 major and 6 minor hemorrhagic events.
Conclusions:
- PFO closure with the APFOO is a viable alternative to medical treatment for CS.
- Larger randomized trials are needed to confirm the superiority of this device over other occluders and medical therapies.
Objectives:
The purpose of this study was to evaluate the efficacy and safety of device closure of patent foramen ovale (PFO) versus antiplatelet therapy in patients with cryptogenic stroke (CS).
Background:
There are no controlled data to support the therapeutic value of PFO closure with a device compared to medical treatment in patients with CS.
Methods:
We performed a nonrandomized, prospective, patient preference case series comparing the recurrence rate in 92 patients with PFO and CS who were treated either with antiplatelet agents (44 patients) or underwent catheter closure (48 patients) using the Amplatzer PFO occluder (APFOO). All patients completed a 2-year follow-up.
Results:
PFO closure group. Immediate complete closure (CC) was observed in 44/48 (91%) patients. Four (9%) patients had a minimal residual shunt immediately after the procedure. One patient developed hemopericardium that was successfully managed by pericardiocentesis. No other complication was observed. Follow-up. PFO closure group. Contrast bubble study at 6-month follow-up confirmed CC in all 48 patients. No complications were observed. Antiplatelet therapy group. Three (6%) and 6 (13%) patients had a major and minor hemorrhagic event, respectively. The average incidence of embolic events/year was 0 and 14.75% for the PFO closure group and the antiplatelet therapy group, respectively (P < 0.001).
Conclusions:
PFO closure using the APFOO is a rational alternative to medical treatment in patients with CS. Larger randomized clinical trials are required to support the use of this device over the other PFO occluders and medical therapy.
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