Patent Foramen Ovale Closure
The Pendulum Swings
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Three randomized controlled trials of percutaneous transcatheter closure of a patent foramen ovale (PFO) in patients with cryptogenic ischemic stroke recently reported a significant reduction in recurrent ischemic stroke with PFO closure plus medical therapy versus medical therapy alone (Table).1–3
Hitherto, a pooled analysis of individual participant data from 2303 patients aged <60 years with cryptogenic stroke enrolled in 3 earlier randomized controlled trials of PFO closure found that, in comparison with medical therapy, transcatheter PFO closure was associated with a borderline significant reduction in the composite of recurrent ischemic stroke, transient ischemic attack, or death (1.5% versus 2.3% per year; hazard ratio, 0.69; 95% confidence interval, 0.47–1.01) and an increase in new-onset atrial fibrillation (AF) (1.44% versus 0.48% per year; hazard ratio, 3.22; 95% confidence interval, 1.76–5.90).4 Given the low rate of recurrent stroke (0.98 per 100 person-years across both arms), uncertain safety and efficacy of PFO closure, and substantial cost of uncomplicated PFO closure of ≈$15 000, the 2016 American Academy of Neurology guidelines recommended that clinicians not routinely offer PFO closure to patients with cryptogenic stroke outside a research setting. Only in rare circumstances, such as recurrent cryptogenic stroke despite adequate medical therapy, did the American Academy of Neurology recommend PFO closure, and if so, by the AMPLATZER PFO disc occluder, because it was considered more likely to decrease recurrent stroke and less …