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Patent Foramen Ovale Closure After Stroke

J Am Coll Cardiol; 2016 March 1; Kent, et al

Publish date:

Patent Foramen Ovale (PFO) closure after stroke reduced recurrent stroke and had a statistically significant effect on the composite of stroke, transient ischemic attack, and death in adjusted but not unadjusted analyses among patients with patent foramen ovale (PFO) and cryptogenic stroke. This according to a pooled analysis of 2,303 patients from 3 completed randomized trials comparing PFO closure vs medical therapy in patients with cryptogenic stroke. Primary composite outcome was stroke, transient ischemic attack, or death. Researchers found:

• Closure was not significantly associated with the unadjusted primary composite outcome; the difference became significant after covariate adjustment (HR=0.68).

• For the outcome of stroke, all comparisons were statistically significant, with unadjusted and adjusted HRs of 0.58 and 0.58, respectively.

• In analyses limited to the 2 disc occluder device trials, the effect of closure was not significant for the composite outcomes, but was for the stroke outcome (aHR=0.39).

Citation: Kent DM, Dahabreh IJ, Ruthazer R, et al. Device closure of patent foramen ovale after stroke. J Am Coll Cardiol 2016;67:907-917. doi:10.1016/j.jacc.2015.12.023.

Commentary: There is an association between PFO and stroke, with that association being stronger the younger the person is who had the stroke. It is estimated that about 25% of the population has a PFO.1 This means, in patients with stroke who have an echocardiogram with a bubble study, there is a good chance that the test will show evidence of a PFO, meaning we will have to make a decision about what to do with the information. In patients with cryptogenic stroke (ie, those with no clear etiology found for their stroke), approximately 40% of patients may have a PFO.2 This meta-analysis suggests that such patients may benefit from PFO closure. Closure in this circumstance is not currently recommended in guidelines. The current American Heart Association guidelines state, “for patients with a cryptogenic ischemic stroke or TIA and a PFO without evidence for DVT, available data do not support a benefit for PFO closure (Class III).”3 —Neil Skolnik, MD

1. Hagen PT, Scholz DG, Edwards WD. Incidence and size of patent foramen ovale during the first 10 decades of life: an autopsy study of 965 normal hearts. Mayo Clin Proc 1984;59:17–20.

2. Lechat P, Mas JL, Lascault G, et al. Prevalence of patent foramen ovale in patients with stroke. N Engl J Med 1988;318:1148–52.

3. Guidelines for the Prevention of Stroke in Patients With Stroke and Transient Ischemic Attack: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2014; 45: 2160-2236. doi:10.1161/STR.0000000000000024.

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