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Published on: February 26, 2013
Risk of Ischemic Stroke After Patent Foramen Ovale Closure
Kasper Bonnesen1, Kasper Korsholm2, Asger Andersen2
1Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark; Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.
Insights
Transcatheter patent foramen ovale (PFO) closure is recommended for cryptogenic stroke, but stroke recurrence risk remains higher than in the general population. This study shows real-world data on PFO closure outcomes for stroke prevention.
Area of Science:
- Cardiology
- Neurology
- Public Health
Background:
- Transcatheter patent foramen ovale (PFO) closure is a recommended treatment for cryptogenic stroke in patients aged 18-60 with a high likelihood of PFO-related events.
- Limited data exist regarding stroke recurrence after PFO closure in real-world clinical practice outside of controlled trials.
Purpose of the Study:
- To investigate the incidence of stroke recurrence following patent foramen ovale closure in routine clinical practice.
- To compare the risk of ischemic stroke in patients who underwent PFO closure versus a matched general population cohort.
Main Methods:
- A nationwide population-based cohort study was conducted using Danish registries from 2008 to 2021.
- Included were 1,162 patients who underwent PFO closure and 11,620 matched individuals from the general population.
- Weighted Cox regression was used to estimate adjusted Hazard Ratios (HRs) for ischemic stroke within 4 years post-PFO closure.
Main Results:
- The absolute 4-year risk of ischemic stroke was 2.5% (95% CI: 1.5%-4.0%) in the PFO closure group and 0.4% (95% CI: 0.3%-0.6%) in the general population.
- This represents an absolute increase of 2.1% (95% CI: 0.9%-3.3%) in ischemic stroke risk over 4 years for patients with PFO closure.
- The adjusted Hazard Ratio for ischemic stroke was 6.3 (95% CI: 3.1-12.6) for patients with PFO closure compared to the general population.
Conclusions:
- The 4-year risk of ischemic stroke after PFO closure in routine practice is comparable to findings from clinical trials.
- Despite comparable trial data, the risk of ischemic stroke remains significantly higher in patients who have undergone PFO closure than in the general population.
Background:
Transcatheter patent foramen ovale (PFO) closure is the recommended treatment for patients age 18 to 60 years with cryptogenic stroke having a high probability of being PFO-related. Limited data exist on stroke recurrence after PFO closure outside clinical trials.
Objectives:
The purpose of this study was to examine stroke recurrence after PFO closure in routine clinical practice.
Methods:
We used nationwide population-based Danish registries to conduct a cohort study of all patients with PFO closure during 2008 to 2021 (n = 1,162) and a birth year and sex-matched comparison cohort from the general population (n = 11,620). We calculated absolute and relative risks of ischemic stroke within 4 years after PFO closure. We used weighted Cox regression to estimate adjusted HRs of the association between PFO closure vs the general population and ischemic stroke.
Results:
The absolute risks of ischemic stroke in patients with PFO closure and in the general population, respectively, were 1.4% (95% CI: 0.8%-2.3%) and 0.1% (95% CI: 0.0%-0.1%) at 1 year, 1.4% (95% CI: 0.8%-2.3%) and 0.2% (95% CI: 0.2%-0.4%) at 2 years, 2.2% (95% CI: 1.3%-3.5%) and 0.4% (95% CI: 0.2%-0.5%) at 3 years, and 2.5% (95% CI: 1.5%-4.0%) and 0.4% (95% CI: 0.3%-0.6%) at 4 years. Thus, the absolute 4-year risk of ischemic stroke was 2.1% (95% CI: 0.9%-3.3%) higher in patients with PFO closure than in the general population, corresponding to an adjusted HR of 6.3 (95% CI: 3.1-12.6).
Conclusions:
The 4-year risk of ischemic stroke after routine PFO closure for cryptogenic stroke was comparable to that observed in clinical trials, but remained higher than in the general population.
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Ischemic Stroke ll: Pathophysiology
Hemorrhagic Stroke ll: Pathophysiology

