Abstract
For patients with cryptogenic stroke found to have a patent foramen ovale (PFO), the rationale for mechanical closure can seem deeply compelling. PFO appears to be a common cause of cryptogenic stroke,1 most likely through a “paradoxical” (venous to arterial) embolism. Since this conduit can be eliminated with a minimally invasive percutaneous procedure, why wait around for a second, possibly disabling, event? Indeed, the logic of closure also has strong support from a wealth of observational studies. Our recent review uncovered 57 studies, describing mostly single-arm case series, but also 7 comparative studies of closure versus medical treatment.2 All together, this observational evidence included 8916 patients: 1903 medically treated, 7013 undergoing closure. The summary incidence rate (IR) of recurrent neurological events (stroke or transient ischemic attack) in closure studies was extremely low (0.8 [0.6–1.2] per 100 person-years). Notably, of 49 studies investigating closure-treated patients, more than half had absolutely no stroke recurrences on follow-up. In contrast, the IR of recurrent events among medically treated patients was considerably …
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