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Updated: Apr 16, 2026
Closure of a Patent Foramen Ovale PFO: An Intervention Sequence
Published on: December 23, 2022
Percutaneous patent foramen ovale closure: the Paradoxical Cerebral Embolism Prevention Registry
Luís Paiva1, Paulo Dinis1, Rui Providência1
1Serviço de Cardiologia, Hospital Geral, Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal.
Insights
Percutaneous closure of patent foramen ovale (PFO) is a safe and effective treatment for preventing recurrent cryptogenic stroke or TIA. This procedure significantly reduces the risk of future events compared to medical therapy alone.
Area of Science:
- Cardiology
- Neurology
- Interventional Cardiology
Background:
- Secondary prevention strategies for patients with patent foramen ovale (PFO) after cerebrovascular events remain undefined.
- The role of percutaneous PFO closure in managing cryptogenic stroke and TIA requires further investigation.
Purpose of the Study:
- To evaluate the safety and efficacy of percutaneous PFO closure for secondary prevention in patients with ischemic cerebrovascular disease of unknown etiology.
- To assess the long-term outcomes of PFO closure in preventing recurrent stroke or transient ischemic attack (TIA).
Main Methods:
- Prospective observational study involving patients with a history of cryptogenic TIA or stroke who underwent percutaneous PFO closure.
- Effectiveness assessed by comparing observed ischemic events with expected rates, using a total exposure of 542 patient-years.
- Evaluation of device implantation in patients with high-risk PFO characteristics.
Main Results:
- Seven primary endpoint events occurred during a mean follow-up of 4.3 years (1.3 per 100 patient-years).
- Percutaneous PFO closure demonstrated a 68.2% relative risk reduction in recurrent TIA or stroke compared to medical therapy alone.
- The procedure exhibited a low complication rate of 1.5% for device- or intervention-related issues.
Conclusions:
- Percutaneous PFO closure is a safe and effective therapeutic option for secondary prevention in patients experiencing cryptogenic stroke or TIA.
- Long-term data from this registry support the use of PFO closure to reduce the risk of recurrent cerebrovascular events.
Introduction:
The natural history and therapeutic interventions for secondary prevention after a cerebrovascular event in patients with patent foramen ovale (PFO) are not yet established. This study aims to assess the safety and efficacy of percutaneous PFO closure in a population of patients with ischemic cerebrovascular disease of unknown etiology.
Methods:
This prospective observational study included patients with a history of cryptogenic transient ischemic attack (TIA) or stroke who underwent percutaneous PFO closure. The effectiveness of the device for the secondary prevention of TIA or stroke was assessed by comparing observed events in the sample with expected events for this clinical setting.
Results:
The sample included 193 cases of percutaneous PFO closure (age 46.4 ± 13.1 years, 62.2% female) with a mean follow-up of 4.3 ± 2.2 years, corresponding to a total exposure to ischemic events of 542 patient-years. The high-risk characteristics of the PFO were assessed prior to device implantation. There were seven primary endpoint events during follow-up (1.3 per 100 patient-years), corresponding to a relative risk reduction of 68.2% in recurrent TIA or stroke compared to medical therapy alone. The procedure was associated with a low rate of device- or intervention-related complications (1.5%).
Conclusions:
In this long-term registry, percutaneous PFO closure was shown to be a safe and effective therapy for the secondary prevention of cryptogenic stroke or TIA.
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