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Standardized Mortality Ratio and Long-Term Stroke Incidence After PFO Closure: A Register Study
Maria Angerbjörn1, Bengt Johansson2, Elisabeth Hahlin2
1Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden.
JACC. Advances
|December 19, 2025
Summary
Patent foramen ovale (PFO) closure in cryptogenic stroke patients showed lower mortality than the general population. Subsequent stroke risk was similar to trials, with new atrial fibrillation and smoking as key modifiable risks.
Area of Science:
- Cardiology
- Neurology
- Public Health
Background:
- Patent foramen ovale (PFO) closure is often recommended for cryptogenic stroke patients.
- Long-term real-world outcomes following PFO closure remain largely unknown.
Purpose of the Study:
- To analyze standardized mortality ratio (SMR), subsequent stroke rates, and associated risk factors after PFO closure.
- To assess the long-term efficacy and safety of PFO closure in a real-world setting.
Main Methods:
- Utilized national registers for congenital heart disease and stroke to identify 827 patients who underwent PFO closure (2001-2018).
- Calculated SMR by comparing observed to expected deaths.
- Employed survival analysis and Cox regression to identify risk factors for subsequent events.
Main Results:
- A total of 827 patients were followed for a median of 8.0 years.
- Observed a significantly lower SMR (0.65) compared to the general population.
- Documented 34 ischemic strokes, with new-onset atrial fibrillation and active/previous smoking identified as significant risk factors (HR: 8.2 and 2.5, respectively).
Conclusions:
- PFO closure is associated with reduced all-cause mortality compared to the general population.
- Subsequent ischemic stroke rates align with findings from randomized controlled trials.
- New-onset atrial fibrillation and smoking are modifiable risk factors that warrant attention post-PFO closure.
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