Cohort study
Patent Foramen Ovale (PFO) Device Closure in Patients >60 Years of Age With Ischemic Stroke
- Retrospective cohort study
- propensity-score matched (1:4)
- Medicare fee-for-service data
Authors' conclusion
In a real-world U.S. cohort of patients >60 years of age, PFO closure was associated with a reduced risk for recurrent ischemic stroke compared with medical therapy alone, while maintaining a clinically acceptable safety profile.
Study context
- Population
- Medicare patients >60 years hospitalized with ischemic stroke and PFO or atrial septal defect, US, 2016–2022matched cohort n = 5,508
- Participants
- 20,999 patients
- Exposure
- PFO device closure vs no device implantation
- Devicen = 1,132
- Controln = 4,376reference
- Outcome
- Recurrent ischemic stroke
- Follow-up
- Through 3 years
Main finding
As reported in the abstract
Hazard ratio
0.62
95% CI 0.44–0.88
P = 0.007
By group
Device vs Control
HR 0.62 (95% CI 0.44–0.88); P = 0.007
Observational data: associations, not effects.
Further findings
30-day death
- Not different between groups
Safety
30-day VTE · more common with device
P < 0.001
30-day AF or flutter · more common with device
P = 0.01
Original publication
PFO Device Closure in Patients >60 Years of Age With Ischemic Stroke. JACC Cardiovasc Interv. Published 26 May 2025. doi:10.1016/j.jcin.2025.03.034
Summarised from the published abstract; every number is checked against it