Related Experiment Video
Updated: Aug 26, 2025
Closure of a Patent Foramen Ovale PFO: An Intervention Sequence
Published on: December 23, 2022
Association of Atrial Septal Aneurysm and Shunt Size With Stroke Recurrence and Benefit From Patent Foramen Ovale
Jean-Louis Mas1, Jeffrey L Saver2, Scott E Kasner3
1GHU Paris Psychiatrie et Neurosciences, Hôpital Sainte-Anne, Service de Neurologie, Institut de Psychiatrie et Neurosciences de Paris, Université de Paris-Cité, Paris, France.
Insights
Patent Foramen Ovale (PFO) closure significantly reduces recurrent stroke risk. The benefit is greatest for patients with large shunts and atrial septal aneurysms (ASA), highlighting the importance of these PFO features.
Area of Science:
- Cardiology
- Neurology
- Vascular Medicine
Background:
- Patent Foramen Ovale (PFO) is a potential cause of stroke.
- The PFO-Associated Stroke Causal Likelihood classification system uses patient and PFO features to predict treatment response.
- The specific impact of PFO shunt size and atrial septal aneurysm (ASA) on stroke recurrence after PFO closure needs further clarification.
Purpose of the Study:
- To investigate the association between Patent Foramen Ovale (PFO) closure and recurrent ischemic stroke.
- To evaluate how PFO shunt size and the presence of an atrial septal aneurysm (ASA) modify the effectiveness of PFO closure in preventing stroke recurrence.
Main Methods:
- Pooled individual patient data from 6 randomized clinical trials comparing PFO closure with medical therapy.
- Analysis included 3740 patients with PFO-associated stroke, stratified by PFO shunt size (small vs. large) and presence/absence of ASA.
- Recurrent ischemic stroke was the primary outcome, assessed over a median follow-up of 57 months.
Main Results:
- PFO closure significantly reduced the risk of recurrent ischemic stroke (aHR, 0.41).
- The benefit of PFO closure was significantly greater in patients with both a large shunt and an ASA (aHR, 0.15) compared to other subgroups.
- Patients with large shunt and ASA experienced a greater absolute risk reduction in recurrent stroke at 2 years (5.5%) compared to other categories (1.0%).
Conclusions:
- PFO closure is effective in reducing recurrent stroke, particularly in patients with specific PFO characteristics.
- A combination of large shunt size and the presence of an ASA identifies patients who derive the most substantial benefit from PFO closure.
- These findings can aid in shared decision-making between patients and clinicians regarding PFO closure treatment.
Importance:
The Patent Foramen Ovale (PFO)-Associated Stroke Causal Likelihood classification system combines information regarding noncardiac patient features (vascular risk factors, infarct topography) and PFO features (shunt size and presence of atrial septal aneurysm [ASA]) to classify patients into 3 validated categories of responsiveness to treatment with PFO closure. However, the distinctive associations of shunt size and ASA, alone and in combination, have not been completely delineated.
Objective:
To evaluate the association of PFO closure with stroke recurrence according to shunt size and/or the presence of an ASA.
Design, Setting, And Participants:
Pooled individual patient data from 6 randomized clinical trials conducted from February 2000 to October 2017 that compared PFO closure with medical therapy. Patients in North America, Europe, Australia, Brazil, and South Korea with PFO-associated stroke were included. Analysis was completed in January 2022.
Exposures:
Transcatheter PFO closure plus antithrombotic therapy vs antithrombotic therapy alone, stratified into 4 groups based on the combination of 2 features: small vs large PFO shunt size and the presence or absence of an ASA.
Main Outcomes And Measures:
Recurrent ischemic stroke.
Results:
A total of 121 recurrent ischemic strokes occurred in the pooled 3740 patients (mean [SD] age, 45 [10] years; 1682 [45%] female) during a median (IQR) follow-up of 57 (23.7-63.8) months. Treatment with PFO closure was associated with reduced risk for recurrent ischemic stroke (adjusted hazard ratio [aHR], 0.41 [95% CI, 0.28-0.60]; P < .001). The reduction in hazard for recurrent stroke was greater for patients with both a large shunt and an ASA (aHR, 0.15 [95% CI, 0.06-0.35]) than for large shunt without ASA (aHR, 0.27 [95% CI, 0.14-0.56]), small shunt with ASA (aHR, 0.36 [95% CI, 0.17-0.78]), and small shunt without ASA (aHR, 0.68 [95% CI, 0.41-1.13]) (interaction P = .02). At 2 years, the absolute risk reduction of recurrent stroke was greater (5.5% [95% CI, 2.7-8.3]) in patients with large shunt and ASA than for patients in the other 3 categories (1.0% for all).
Conclusions And Relevance:
Patients with both a large shunt and an ASA showed a substantially greater beneficial association with PFO closure than patients with large shunt alone, patients with small shunt and ASA, and patients with neither large shunt nor ASA. These findings, combined with other patient features, may inform shared patient-clinician decision-making.
Related Concept Videos
01:26Aneurysm III: Interprofessional Care
01:21Aneurysm II: Clinical Manifestations and Diagnostic Studies
01:26Mitral Stenosis III: Medical Management