Patent foramen ovale closure to prevent secondary neurologic events.

In October of 2016 the United States Food and Drug Administration approved the Amplatzer Patent Foramen Ovale (PFO) occluder device for use in patients with cryptogenic stroke, to reduce the risk of recurrent stroke. This event followed 15years of off-label use of atrial septal occluder devices, 3 randomized trials, and enormous controversy over the efficacy of this procedure. While none of the trials reached the primary endpoint needed to prove the efficacy of PFO closure in preventing recurrent stroke, meta-analyses and 5-year follow-up of 1 trial suggest that PFO closure decreases the risk of recurrent stroke, especially in sub-groups with large shunts and atrial septal aneurysms, and especially when the Amplatzer device (rather than other devices) is used. While the relative reduction in stroke associated with PFO closure is large (about 50%), the absolute reduction is low (1-2%) and must be balanced against complications of the procedure (about 3%). Thus, PFO closure is restricted to patients with cryptogenic stroke, and depends heavily on patients' personal preferences. Uncertainties about the etiology of stroke in patients with PFO and the efficacy of PFO closure cause a difficult problem for the internal medicine specialist. At one extreme the internist may wonder if every patient with a documented PFO should be referred to a cardiologist. At the other extreme, supported by specialty society guidelines, internists may conclude that PFO closure is rarely necessary. In this paper we review the current status of PFO closure and suggest a rational strategy for this procedure.