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Updated: Jul 2, 2025
Closure of a Patent Foramen Ovale PFO: An Intervention Sequence
Published on: December 23, 2022
Amplatzer or Figulla Flex II Occluder: a comparative study of outcomes after transcatheter patent foramen ovale
Stefan Toggweiler1, Federico Moccetti1, Nina Conrad1
1The Heart Center Lucerne, Luzerner Kantonsspital, Lucerne, Switzerland.
Insights
Percutaneous closure of patent foramen ovale (PFO) using two devices is safe and effective. Both the Abbott Amplatzer occluder and Occlutech Figulla Flex II occluder achieved high rates of successful PFO closure.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Devices
Background:
- Patent foramen ovale (PFO) closure is established for preventing paradoxical thromboembolic events.
- Uncertainty exists regarding the impact of different occluder device designs on clinical outcomes.
- This study compares two widely used double-disc PFO occluders.
Purpose of the Study:
- To compare the outcomes of percutaneous PFO closure using the Abbott Amplatzer occluder (APO) and the Occlutech Figulla-Flex-II occluder (OPO).
- To evaluate the efficacy and safety of these devices in preventing recurrent paradoxical thromboembolic events.
Main Methods:
- A registry of consecutive patients undergoing percutaneous PFO closure with either APO or OPO between February 2017 and December 2022.
- Primary endpoint: effective PFO closure (residual shunt grade 0 or 1) at 6-month follow-up via contrast echocardiogram.
- Secondary endpoints: procedural efficacy, safety, and major adverse cardiovascular events.
Main Results:
- 193 patients (mean age 51.7 years) received either APO (62.2%) or OPO (37.8%).
- Primary indication was cryptogenic stroke (87.1%).
- Effective closure at 6 months was 95.8% (APO: 96.6% vs. OPO: 94.5%, P = .30). No significant difference between devices.
- Procedural success was 99.5% with one minor air embolism complication.
Conclusions:
- Percutaneous PFO closure is a safe and effective procedure for preventing paradoxical thromboembolic events.
- Both the Abbott Amplatzer and Occlutech Figulla Flex II PFO occluders demonstrate comparable efficacy and safety profiles.
- Device choice does not appear to significantly impact closure rates or major adverse events.
Objectives:
Percutaneous closure of a patent foramen ovale (PFO) for the prevention of recurrent paradoxical thromboembolic events has been shown to be safe and effective in randomized controlled trials. However, it remains uncertain if differences in the structure and design of the occluder devices impact the outcomes. The aim of this study was to compare results of percutaneous PFO closure using 2 widely used double-disc occluders.
Methods:
Consecutive patients who underwent percutaneous PFO closure with the Abbott Amplatzer occluder (APO) or the Occlutech Figulla-Flex-II occluder (OPO) at the Heart Center Lucerne between February 2017 and December 2022 were included in a registry. The primary endpoint was effective closure of the PFO, defined as a residual shunt grade 0 or 1, assessed by contrast echocardiogram at 6-month follow-up. Secondary endpoints included procedural efficacy/safety and major adverse cardiovascular events during the hospital stay and at 6-month follow-up.
Results:
One hundred ninety-three consecutive patients (mean age 51.7 ± 12.5 years; 39% women; Risk of Paradoxical Embolism (RoPE) score = 7, IQR = 6-8) underwent percutaneous PFO closure with the APO (120 patients, 62.2%) or the OPO (73 patients, 37.8%). Main indications for closure were crypotogenic stroke in 168 patients (87.1%) and peripheral embolism in 13 patients (6.7%). At baseline, right-to-left shunt (RLS) greater than or equal to grade 2 was present in 189 patients (97.9%). Immediate procedural success was 99.5%. In 1 patient, an air embolism occurred during positioning of the APO occluder with transient chest pain and electrocardiogram changes, but without further sequelae to the patient. At 6-month follow-up, effective closure was achieved in 185 patients (95.8%; APO: 96.6% vs OPO: 94.5%, P = .30). Rates of atrial fibrillation and recurrent thromboembolic events were 4.2 and 0.5%, respectively.
Conclusions:
PFO closure is safe and effective when performed with either the self-expanding Abbott Amplatzer or Occlutech Figulla Flex II PFO occluder.
