Related Experiment Video
Updated: Sep 28, 2025
Closure of a Patent Foramen Ovale PFO: An Intervention Sequence
Published on: December 23, 2022
Outcomes Following Patent Foramen Ovale Percutaneous Closure According to the Delay From Last Ischemic Event
Paul Guedeney1, Jules Mesnier2, Michel Zeitouni1
1ACTION Study Group, INSERM UMRS_1166 Institut de Cardiologie (AP-HP), Sorbonne Université, Paris, France.
Insights
Percutaneous closure of patent foramen ovale (PFO) for secondary prevention shows similar outcomes regardless of the delay after the last embolic event. This study suggests timing is not a critical factor for preventing stroke or TIA after PFO closure.
Area of Science:
- Cardiology
- Neurology
- Medical Devices
Background:
- Randomized controlled trials for percutaneous closure of patent foramen ovale (PFO) have focused on patients with recent embolic events.
- The optimal timing for PFO closure relative to the last embolic event remains unclear.
Purpose of the Study:
- To evaluate the outcomes of percutaneous PFO closure based on the time delay from the last embolic episode.
- To identify determinants of late PFO closure procedures.
Main Methods:
- An international ambispective cohort study included 1179 patients undergoing PFO closure for secondary prevention of paradoxical embolic events.
- The primary endpoint was a composite of stroke or transient ischemic attack (TIA).
- Logistic regression was used to analyze determinants of late PFO closure, and outcomes were compared between early and late procedures.
Main Results:
- The median delay from the last embolic event to PFO closure was 6.0 months.
- Determinants of late closure included center, year of procedure, female sex, and lower paradoxical embolism risk score.
- No significant difference in the incidence rate of stroke or TIA was observed between early and late PFO closure procedures (0.51 vs 0.29 events per 100 patient-years).
Conclusions:
- The delay from the last ischemic event does not appear to affect outcomes after PFO closure for secondary prevention.
- Timing of PFO closure was not associated with the occurrence of stroke or TIA.
Background:
Randomised controlled trials evaluating percutaneous closure of patent foramen ovale (PFO) have included only patients with a recent embolic event. We aimed to evaluate outcomes after percutaneous PFO closure according to the delay from the last embolic episode.
Methods:
This international ambispective cohort included consecutive patients from 2 centres in France and Canada undergoing PFO closure for secondary prevention of a paradoxical embolic event. The primary end point was the composite of stroke or transient ischemic attack (TIA). A logistic regression model was used to evaluate determinants of late PFO closure procedures.
Results:
A total of 1179 patients (mean age 49 ± 12.7 years; 44.4% female) underwent PFO closure from 2001 to 2021. The median delay from last embolic event to procedure was 6.0 (interquartile range 3.4-11.2) months. The determinants of late PFO closure procedure were the centre (France vs Canada; adjusted odds ratio [aOR] 1.65, 95% confidence interval [CI] 1.25-2.19), year of procedure (since 2018 vs before 2018; aOR 1.43, 95% CI 1.08-1.90), female sex (aOR 1.63, 95% CI 1.28-2.07), and lower risk of paradoxical embolism score (aOR 1.10, 95% CI 1.03-1.19). After a median follow-up of 2.61 (1.13-7.25) years, the incidence rate of first stroke or TIA did not differ between early and late PFO procedures, with 0.51 vs 0.29 events per 100 patient-years, respectively (incidence rate ratio 1.74, 95% CI 0.66-5.08; P = 0.24), and the timing of PFO closure was not associated with the occurrence of stroke or TIA in univariate analysis (hazard ratio 0.54, 95% CI 0.22-1.34) for late vs early closure).
Conclusions:
This analysis provides indirect evidence that the delay from the last ischemic event does not affect outcomes after PFO closure for secondary prevention.
