Key result
After adjustment for age and comorbidity, patent foramen ovale was not a significant independent predictor of cerebrovascular events (HR 1.46; 95% CI 0.74-2.88; P=0.28).
Why the study?
The relationship between patent foramen ovale (PFO) and stroke is disputed due to methodological weaknesses in prior studies including invalid controls and lack of adjustment for age or comorbidity.
Does the presence of a patent foramen ovale or atrial septal aneurysm increase the risk of cerebrovascular events in an unselected general population?
Cohort (n=585)
No
Does the presence of a patent foramen ovale or atrial septal aneurysm increase the risk of cerebrovascular events in an unselected general population?
Hazard Ratio: 1.46 (95% CI 0.74–2.88)
p-value: p=0.28
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“Our findings show that the hole is not always the guilty party in a stroke; it may be an innocent bystander. If someone says you have a tiny hole in your heart, it's not doom and gloom. After following patients in our study with small holes in the heart for five years, their risk for stroke was no different than those who did not have the hole.”
“In the general population, it does not appear there is a direct association between the detection of a PFO and having a stroke. Our study looked at the general population with PFO; if you detect PFO in someone who has already had a stroke, one cannot immediately assume that the PFO is causative.”
In a prospective population-based cohort, the presence of a patent foramen ovale was not an independent risk factor for future cerebrovascular events after adjusting for age and comorbidities.
OBJECTIVES: We sought to determine the association between patent foramen ovale (PFO), atrial septal aneurysm (ASA), and stroke prospectively in a unselected population sample. BACKGROUND: The disputed relationship between PFO and stroke reflects methodologic weaknesses in studies using invalid controls, unblinded transesophageal echocardiography examinations, and data that are unadjusted for age or comorbidity. METHODS: The use of transesophageal echocardiography to identify PFO was performed by a single echocardiographer using standardized definitions in 585 randomly sampled, Olmsted County (Minnesota) subjects age 45 years or older participating in the Stroke Prevention: Assessment of Risk in a Community (SPARC) study. RESULTS: A PFO was identified in 140 (24.3%) subjects and ASA in 11 (1.9%) subjects. Of the 140 subjects with PFO, 6 (4.3%) had an ASA; of the 437 subjects without PFO, 5 had an ASA (1.1%, two-sided Fisher exact test, p = 0.028). During a median follow-up of 5.1 years, cerebrovascular events (cerebrovascular disease-related death, ischemic stroke, transient ischemic attack) occurred in 41 subjects. After adjustment for age and comorbidity, PFO was not a significant independent predictor of stroke (hazard ratio 1.46, 95% confidence interval 0.74 to 2.88, p = 0.28). The risk of a cerebrovascular event among subjects with ASA was nearly four times higher than that in those without ASA (hazard ratio 3.72, 95% confidence interval 0.88 to 15.71, p = 0.074). CONCLUSIONS: These prospective population-based data suggest that, after correction for age and comorbidity, PFO is not an independent risk factor for future cerebrovascular events in the general population. A larger study is required to test the putative stroke risk associated with ASA.
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Meissner et al. (2005) conducted a cohort in Patent foramen ovale and atrial septal aneurysm (n=585). Patent foramen ovale vs. No patent foramen ovale was evaluated on Cerebrovascular events (cerebrovascular disease-related death, ischemic stroke, transient ischemic attack) (HR 1.46, 95% CI 0.74-2.88, p=0.28). After adjustment for age and comorbidity, patent foramen ovale was not a significant independent predictor of cerebrovascular events (HR 1.46; 95% CI 0.74-2.88; P=0.28).
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