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J Am Coll Cardiol, 2006; 47:440-445, doi:10.1016/j.jacc.2005.10.044 (Published online 5 December 2005).
© 2005 by the American College of Cardiology Foundation
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EXPEDITED REVIEW

Patent Foramen Ovale: Innocent or Guilty?

Evidence From a Prospective Population-Based Study

Irene Meissner, MD*,||,*, Bijoy K. Khandheria, MD{dagger}, John A. Heit, MD*, George W. Petty, MD*, Sheldon G. Sheps, MD{ddagger}, Gary L. Schwartz, MD{ddagger}, 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
{dagger} Division of Cardiovascular Diseases
{ddagger} 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.

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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