Closure on CLOSURE for Patent Foramen Ovale?

Mark J. Alberts, MD


May 07, 2012

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Hello, and welcome to this Medscape stroke update. I am Dr. Mark Alberts, professor of neurology at Northwestern University in Chicago. Today, I want to update you about the results of the CLOSURE trial.[1] CLOSURE was a prospective randomized trial of the STARFlex closure device in patients who had a PFO (patent foramen ovale) and who had experienced a cryptogenic stroke or a cryptogenic TIA (transient ischemic attack).

Slightly more than 900 patients were enrolled in CLOSURE, and they either had closure of the PFO (with the STARflex device) or received best medical therapy. After about 2 years, we have the results for the endpoint of recurrent stroke. Investigators found that 3% of patients who received the closure device and essentially the same percentage of patients treated with medical therapy had recurrent stroke. There was no statistically significant difference between the groups for recurrent stroke or TIA.

However, more complications were reported in the group that received the closure device; the rate of atrial fibrillation was 5.7% in the folks who received the closure device vs 0.7% in those who received medical therapy. Not all of these patients had persistent atrial fibrillation, but it did persist to the end of the study for some of them.

Thus, we have a controversy about whether or not PFOs need to be closed in people with cryptogenic stroke or TIA. The CLOSURE study found no evidence that closing the PFOs was beneficial in most of these patients. Moreover, the complication rate was higher after PFO closure.

I and some of my colleagues around the country are involved in another study, called the RESPECT trial, that is looking at a different closure device in a similar population of patients. That study is ongoing. But based on what we know now, there is no clear reason to close the PFO in the vast majority of these patients.

Thank you very much for your attention to this blog. I hope the information was useful. Have a good day.


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