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Published on: January 18, 2018
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.
Insights
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.
Background:
Closure of a patent foramen ovale (PFO) is frequently recommended in patients with cryptogenic stroke. Long-term outcomes in real-world settings remain unknown.
Objectives:
This study analyzed standardized mortality ratio (SMR), subsequent stroke, and associated risk factors after PFO closure.
Methods:
National registers on congenital heart disease and stroke were cross-linked to identify individuals who underwent PFO closure between 2001 and 2018. The ratio of observed to expected deaths was calculated (SMR). Data were analyzed using survival analysis and Cox regression.
Results:
A total of 827 patients (60.5% males, median age 47.9 years, IQR: 40.0-55.6 at the time of PFO closure) were included and observed for a median duration of 8.0 years (IQR: 4.8-11.0). During follow-up, 23 patients died, SMR was 0.65 (95% CI: 0.41-0.98). A total of 34 ischemic strokes occurred, yielding an incidence rate of 0.51 events per 100 patient-years. Among the 34 patients who experienced a subsequent stroke, 27 were receiving antithrombotic therapy at the time of the event. New-onset atrial fibrillation following PFO closure was associated with an increased risk of subsequent ischemic stroke (HR: 8.2; 95% CI: 2.6-25.8), as was active/previous smoking (HR: 2.5; 95% CI: 1.2-5.1).
Conclusions:
Patients undergoing PFO closure demonstrated a lower all-cause mortality compared to the general population. The observed rate of subsequent ischemic stroke was consistent with findings from previous randomized controlled trials. New-onset atrial fibrillation following PFO closure and active/previous smoking emerged as modifiable risk factors.
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