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Updated: Mar 20, 2026

Closure of a Patent Foramen Ovale PFO: An Intervention Sequence
Published on: December 23, 2022
Transcatheter closure of PFO as secondary prevention of cryptogenic stroke
R De Vecchis1, C Baldi2, S Cantatrione3
1Cardiology Unit, Presidio Sanitario Intermedio "Elena d'Aosta", ASL Napoli 1 Centro, via Cagnazzi 29, 80137, Naples, Italy. devecchis.erre@virgilio.it.
Insights
Patent foramen ovale closure for cryptogenic stroke remains debated. Current evidence does not consistently support device closure over medical therapy, warranting further investigation with newer devices.
Area of Science:
- Cardiology
- Neurology
- Medical Devices
Background:
- Patent foramen ovale (PFO) is a potential cause of cryptogenic stroke.
- Uncertainty exists regarding the optimal secondary prevention strategy for patients with PFO and stroke history.
Purpose of the Study:
- To review unsolved issues concerning the role of PFO in cryptogenic stroke.
- To analyze the evidence comparing transcatheter PFO closure with medical therapy for stroke prevention.
Main Methods:
- Review of PFO anatomy, epidemiology, and relevant clinical trials.
- Analysis of meta-analyses and current scientific guidelines on PFO closure versus antithrombotic therapy.
Main Results:
- Conflicting results from meta-analyses of major trials comparing PFO closure and medical therapy.
- Guidelines do not universally recommend PFO closure over antithrombotic therapy, except in specific cases (e.g., concomitant deep venous thrombosis).
Conclusions:
- The superior efficacy of transcatheter PFO occlusion over antithrombotic therapy alone is disputed.
- Further research with novel PFO closure devices is needed to clarify their role in stroke prevention compared to antithrombotic regimens.
Abstract:
This article covers the main unsolved issues regarding the potential role that the patent foramen ovale (PFO) plays in the genesis of so-called cryptogenic stroke. Some brief notions of the anatomy and epidemiology of the PFO are outlined. Subsequently, the results of the three trials on secondary prevention (medical therapy vs. transcatheter closure) in patients with PFO and a history of cryptogenic stroke are presented. The conflicting results of numerous meta-analyses derived from the three randomized controlled trials are discussed. Official scientific guidelines dispute an alleged superior efficacy of transcatheter PFO occlusion in comparison with antithrombotic therapy alone (anticoagulants or antiplatelet agents), except for selected cases of patients with documented PFO and a concomitant clinical-instrumental picture of deep venous thrombosis. Nevertheless, considering recent doubts about the presumptive thrombogenic and arrhythmogenic potential of PFO occlusion, which concerns only one of the septal occluders previously used, further in-depth investigations are warranted, centered on the use of newer dedicated devices to be tested in comparison with antithrombotic regimens alone.
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