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Patent foramen ovale (PFO) occurs in about one of four patients, so attributing PFO as the cause of an otherwise cryptogenic stroke is often based on circumstantial evidence. Three clinical trials (CLOSURE I, PC, and RESPECT) failed to establish a role for PFO closure in preventing recurrent stroke. Accordingly, a 2016 American Academy of Neurology practice advisory recommended against routine PFO closure for patients with cryptogenic ischemic stroke. Now two new randomized trials and an exploratory analysis of extended follow-up from RESPECT are set to agitate the mix.
In the industry-sponsored Gore REDUCE trial, 664 patients with cryptogenic stroke and PFO (81% with moderate-to-large shunts, defined as >6 microbubbles within 3 cardiac cycl…