No Apparent Benefit from PFO Closure After Cryptogenic Stroke

Summary and Comment |
March 14, 2012

No Apparent Benefit from PFO Closure After Cryptogenic Stroke

  1. Hooman Kamel, MD

In the first published randomized trial of patent foramen ovale closure, recurrent strokes were uncommon and usually unrelated to PFO.

  1. Hooman Kamel, MD

At least 20% of strokes have no known cause and are labeled as cryptogenic. Patients with cryptogenic stroke have a high prevalence of patent foramen ovale (PFO), suggesting that this passage between the right and left heart allows paradoxical embolization from the systemic circulation. Cardiac devices for treating atrial septal defects are used off-label to close PFOs after cryptogenic stroke, but rigorous evidence about this practice has been lacking. Investigators have now performed a trial comparing PFO closure (using the study sponsor's device) with medical therapy alone. During a 5-year period, the investigators randomized 909 patients at 87 sites to closure or medical therapy alone (aspirin, warfarin, or both). Participants were aged 18 to 60 with recent stroke or transient ischemic attack (TIA), right-to-left shunting on transesophageal echocardiography, and no identifiable cause of stroke besides PFO.

PFO closure was durably successful in 86.7% of closure-device recipients. Cumulatively over 2 years, recurrent stroke or TIA occurred in 5.5% of the closure group versus 6.8% of the medical-therapy group, a nonsignificant difference (adjusted hazard ratio, 0.78; 95% confidence interval, 0.45–1.35). Most recurrent events had sources unrelated to PFO.


Although this trial was not adequately powered to exclude a small benefit from PFO closure, the findings confirm that stroke recurrence is uncommon in this population. Thus, even a low rate of procedural complications makes it difficult to improve on the natural history of uncorrected PFO. Closure might benefit a subset of high-risk patients with paradoxical embolization, but until this group can be reliably identified and shown to benefit, routine PFO closure cannot be recommended for cryptogenic stroke. Pooling these results with those from the recently completed RESPECT trial and ongoing REDUCE trial may shed more light on this issue.

Howard C. Herrmann, MD, a coauthor of this study, is a member of the Editorial Board for Journal Watch Cardiology. He had no role in the selection of this study for coverage or in the preparation or review of this summary.


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