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Updated: Apr 16, 2026
Closure of a Patent Foramen Ovale PFO: An Intervention Sequence
Published on: December 23, 2022
Using the GORE® Septal Occluder (GSO) in challenging patent foramen ovale (PFO) anatomies
Nicolas A Geis1, Sven T Pleger, Hugo A Katus
1Department of Internal Medicine III, University of Heidelberg, Germany.
Insights
The Gore(®) Septal Occluder effectively closes patent foramen ovale (PFO) in patients with complex septal conditions like atrial septal aneurysms or long PFO tunnels. This study shows a high closure rate and good safety profile for PFO closure in challenging anatomies.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Devices
Background:
- Percutaneous patent foramen ovale (PFO) closure is debated versus medical therapy for preventing recurrent embolic events after cryptogenic stroke.
- Patient selection is key, focusing on individuals with PFO-related stroke risk.
- Complex septal anatomies, including atrial septal aneurysms (ASA) and long PFO tunnels, are linked to higher stroke rates.
Purpose of the Study:
- To evaluate the efficacy and safety of the Gore(®) Septal Occluder (GSO) for PFO closure.
- To specifically assess GSO performance in patients with challenging septal anatomies, such as ASA and long PFO tunnels.
Main Methods:
- The GSO device was used for PFO closure in 41 patients.
- Patients had challenging anatomies: ASA (65.9%), long PFO tunnel >10mm (78%), or both (43.9%).
- Seven patients had tunnel lengths ≥20mm.
Main Results:
- Successful GSO implantation in all patients with no procedural complications.
- Excellent short-term and mid-term follow-up results.
- High complete closure rate of 95.1% at 6 months.
- Late complications occurred in 7.3% (atrial fibrillation, device thrombus).
Conclusions:
- The Gore(®) Septal Occluder demonstrates efficiency and safety for PFO closure.
- It is particularly effective in patients with challenging anatomies, including long-tunnel PFOs and atrial septal aneurysms.
Objectives:
We assessed efficacy and safety of the Gore(®) Septal Occluder (GSO) for patent foramen ovale (PFO) closure focusing on patients with challenging septal anatomies.
Background:
In times of controversial discussion whether percutaneous PFO closure is superior to medical therapy for the prevention of recurrent embolic events after cryptogenic stroke, patient selection should mainly focus on individuals with an increased likelihood that the ischaemic event is related to the PFO. In this context, specific septal anatomies-such as the presence of an atrial septal aneurysm as well as long PFO tunnel anatomy-have been associated with a higher rate of cerebrovascular accidents.
Methods:
The GSO was used for PFO closure in 41 patients presenting with either atrial septal aneurysm (ASA; 27/41; 65.9%) or long PFO tunnel (> 10 mm; 32/41; 78%). Seven of these patients even presented with a tunnel length ≥ 20 mm (7/41; 17.1%). Eighteen patients had both, long-tunnel anatomy and ASA (18/41; 43.9%).
Results:
The GSO was successfully implanted in all cases. No procedural complications occurred and all patients were discharged the day after the procedure. Short-term follow-up, including TEE examination, in all patients was performed 37.6 ± 9.0 days after the procedure. Mid-term follow-up was performed after 192.7 ± 45.3 days. Later complications occurred in 7.3% (2 new onset atrial fibrillation, 1 device thrombus). Only 3 patients (7.3%) had more than trace residual shunts at 6-weeks follow-up. At 6-months follow-up, the complete closure rate was 95.1% (39/41).
Conclusions:
The Gore(®) Septal Occluder is an efficient device for patent foramen ovale closure in challenging anatomies, including long-tunnel PFOs and atrial septal aneurysms.
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