Patent foramen ovale (PFO) is the most common congenital heart abnormality of fetal origin and is present in approximately ∼25% of the worldwide adult population. PFO is the consequence of failed closure of the foramen ovale, a normal structure that exists in the fetus to direct blood flow directly from the right to the left atrium, bypassing the pulmonary circulation. PFO has historically been associated with an increased risk of stroke, the mechanism of which has been attributed to the paradoxical embolism of venous thrombi that shunt through the PFO directly to the left atrium. However, several studies have failed to show an increased risk of stroke in asymptomatic patients with a PFO, and the risk of stroke recurrence is low in patients who have had a stroke that may be attributed to a PFO. With the advent of transoesophageal and transthoracic echocardiography, as well as transcranial Doppler, a PFO can be routinely detected in clinical practice. Medical treatment with either antiplatelet or anticoagulation therapy is recommended. At the current time, closure of the PFO by percutaneous interventional techniques does not appear to reduce the risk of stroke compared to conventional medical treatment, as shown by three large clinical trials. Considerable controversy remains regarding the optimal treatment strategy for patients with both cryptogenic stroke and PFO. This Primer discusses the epidemiology, mechanisms, pathophysiology, diagnosis, screening, management and effects on quality of life of PFO.
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S.H. has served on the data safety and monitoring board for the RESPECT trial with St. Jude Medical and as an ad hoc consultant with Daiichi Sankyo and Bristol-Meyers Squibb Pfizer. S.R.M. is the local principal investigator for the Gore Helex Reduce trial, for which he has received salary support (modest, that is, <$5,000 per year). He has also received travel support from the American Academy of Neurology (AAN) to attend the Guideline Development Subcommittee meetings. H.S. has received study honoraria, travel expenses and consulting fees (<€25,000) from Abbott, Aptus Endosystems, Atrium, Biosense Webster, Boston Scientific, Carag, Cardiac Dimensions, CardioKinetix, CardioMEMS, Cardiox, Celonova, CGuard, Coherex Medical, Comed B.V., Contego Medical, Covidien, CSI, CVRx, ev3, FlowCardia, Gardia Medical, Gore, GTIMD Catheter Solutions, Guided Delivery Systems, Hemoteq, InSeal Medical, InspireMD, Kona Medical, Lumen Biomedical, Lifetech Scientific, Lutonix, Maya Medical, Medtronic, Occlutech, pfm Medical, Record, ResMed, SentreHeart, Spectranetics, Svelte Medical Systems, Tendyne, TriReme Medical, Trivascular, Valtech, Vascular Dynamics, Venus Medical, Veryan Medical and Vessix Vascular. He also owns stock options (<€25,000) from Cardiokinetix, Access Closure, Coherex Medical and SMT Medical. R.L.S. was a past consultant to Boehringer Ingelheim for the design and implementation of a secondary stroke prevention trial with dabigatran versus aspirin. The other authors have no relevant financial relationships with industry to disclose.
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Homma, S., Messé, S., Rundek, T. et al. Patent foramen ovale. Nat Rev Dis Primers 2, 15086 (2016). https://doi.org/10.1038/nrdp.2015.86
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