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. 2025 Apr;20(4):450-460.
doi: 10.1177/17474930241298778. Epub 2024 Nov 20.

Stroke recurrence after transcatheter PFO closure in patients with cryptogenic stroke

Bea Goessinger  1 , Stefan Greisenegger  2 , Stefan Kastl  1 , Raphael Rosenhek  1 , Wolfgang Serles  2 , Christian Hengstenberg  1 , Harald Gabriel  1 , Lore Schrutka  1
Affiliations

Stroke recurrence after transcatheter PFO closure in patients with cryptogenic stroke

Bea Goessinger et al. Int J Stroke. 2025 Apr.

Abstract

Background: Patent foramen ovale (PFO) closure is recommended for secondary prevention of cryptogenic stroke. However, data on long-term results are limited. We aimed to evaluate safety and efficacy of transcatheter PFO closure and predict neurologic recurrence.

Methods: Data from patients undergoing PFO closure between 2010 and 2015 were collected to assess the combined endpoint of transient ischemic attack (TIA), stroke, or death from stroke at short- and long-term follow-up.

Results: 330 patients were included, mean age was 49 (±12) years, and 55.5% were male. Before PFO closure, 86% experienced a stroke and 19% multiple neurological events. Procedure-related complications occurred in 2.4% of patients. Over a median follow-up of 10 years, the combined endpoint occurred in 3.6%, with a recurrence rate of 0.38 per 100 patient-years. Freedom from the combined endpoint at 5 and 10 years was 97.5% and 96.2%, respectively. New-onset atrial fibrillation was detected in 3%. The Risk of Paradoxical Embolism (RoPE) score (adjHR: 0.68; p = 0.032), the PFO-Associated Stroke Causal Likelihood (PASCAL) classification system (adjHR: 0.37; p = 0.042), and a history of prior neurological events (adjHR: 9.94; p < 0.001) were independent predictors of future recurrent neurologic events. Age, sex, and cardiovascular risk factors did not influence outcomes.

Conclusion: In this real-world cohort, transcatheter PFO closure was associated with low long-term recurrence of neurologic events, especially cryptogenic strokes. The RoPE score, the PASCAL score, and history of previous neurological events were predictive of recurrent events. This study supports the safety and efficacy of PFO closure for secondary prevention of cryptogenic strokes, and underscores the importance of patient selection.

Keywords: PFO closure; cryptogenic stroke; outcome; predictors.

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Conflict of interest statement

Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Figures

Graphical abstract
Graphical abstract
Figure 1.
Figure 1.
Patient selection. Selection of patients undergoing catheter based PFO closure between 2010 and 2015.
Figure 2.
Figure 2.
Combined primary outcome of TIA, stroke, or death from stroke. Shown is the Kaplan–Meier curve presenting the years free from recurrent neurological event after transcatheter PFO closure. All patients (n = 330) are included in the analysis. TIA: transient ischemic attack.
Figure 3.
Figure 3.
Kaplan–Meier curves of the combined primary outcome for TIA, stroke, and death from stroke as a function of the rate of previous neurological events. Shown are the Kaplan–Meier curves of the years free from the primary outcome (TIA, stroke, and death from stroke) stratified by the number of neurologic events before closure. Significantly higher rates of recurrent neurologic events were observed in the group with more than one event prior to closure, log-rank p < 0,001. TIA: transient ischemic attack.
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