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.
Abstract

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