EXPEDITED REVIEW
Patent Foramen Ovale: Innocent or Guilty?
Evidence From a Prospective Population-Based Study
Irene Meissner, MD*,||,*,
Bijoy K. Khandheria, MD ,
John A. Heit, MD*,
George W. Petty, MD*,
Sheldon G. Sheps, MD ,
Gary L. Schwartz, MD ,
Jack P. Whisnant, MD ,
David O. Wiebers, MD*,||,
Jody L. Covalt¶,
Tanya M. Petterson||,
Teresa J.H. Christianson|| and
Yoram Agmon, MD*
* Department of Neurology
Division of Cardiovascular Diseases
Division of Nephrology and Hypertension
Department of Health Sciences Research
|| Division of Epidemiology
¶ Stroke Research Center
|| Division of Biostatistics, Mayo Clinic, Rochester, Minnesota
Manuscript received July 28, 2005;
revised manuscript received September 26, 2005,
accepted October 3, 2005.
* Reprint requests and correspondence: Dr. Irene Meissner, Department of Neurology, Mayo Clinic, 200 First Street SW, Rochester, Minnesota 55905 (Email: meissner.irene{at}mayo.edu).
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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Abbreviations and Acronyms
| | ASA = atrial septal aneurysm | | CVD = cerebrovascular events | | IAS = interatrial septum | | PFO = patent foramen ovale | | SPARC = Stroke Prevention: Assessment of Risk in a Community study | | TEE = transesophageal echocardiography | | VTE = venous thromboembolism |
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