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Review
. 2024 Jan;55(1):236-247.
doi: 10.1161/STROKEAHA.123.040546. Epub 2023 Nov 21.

Patent Foramen Ovale Management for Secondary Stroke Prevention: State-of-the-Art Appraisal of Current Evidence

Luciano A Sposato  1   2   3 , Catherine S W Albin  4 , Mitchell S V Elkind  5   6 , Hooman Kamel  7 , Jeffrey L Saver  8
Affiliations
Free article
Review

Patent Foramen Ovale Management for Secondary Stroke Prevention: State-of-the-Art Appraisal of Current Evidence

Luciano A Sposato et al. Stroke. 2024 Jan.
Free article

Abstract

Patent foramen ovale (PFO) is frequently identified in young patients with ischemic stroke. Randomized controlled trials provide robust evidence supporting PFO closure in selected patients with cryptogenic ischemic stroke; however, several questions remain unanswered. This report summarizes current knowledge on the epidemiology of PFO-associated stroke, the role of PFO as a cause of stroke, and anatomic high-risk features. We also comment on breakthrough developments in patient selection algorithms for PFO closure in relation to the PFO-associated stroke causal likelihood risk stratification system. We further highlight areas for future research in PFO-associated stroke including the efficacy and safety of PFO closure in the elderly population, incidence, and long-term consequences of atrial fibrillation post-PFO closure, generalizability of the results of clinical trials in the real world, and the need for assessing the effect of neurocardiology teams on adherence to international recommendations. Other important knowledge gaps such as sex, race/ethnicity, and regional disparities in access to diagnostic technologies, PFO closure devices, and clinical outcomes in the real world are also discussed as priority research topics.

Keywords: algorithm; atrial fibrillation; ethnicity; ischemic stroke; patent foramen ovale.

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Conflict of interest statement

Disclosures Dr Sposato received speaker/consulting honoraria from Boehringer Ingelheim, Pfizer, Bayer, Gore, and Daiichi Sankyo; research grants from Boehringer Ingelheim and Bayer; Editorial Board member, Neurology; Editor, Neurocardiology section, Stroke journal. Associate Editor, JAHA. Dr Albin received research support, American Academy of Neurology; Publishing royalties, publication relating to health care; Personal compensation, Associate Editor, Continuum: Lifelong Learning in Neurology, and received compensation from Springer Nature for other services. Dr Elkind: PI, ARCADIA trial (The Atrial Cardiopathy and Antithrombotic Drugs in Prevention After Cryptogenic Stroke Randomized Trial; National Institutes of Health [NIH]/National Institute of Neurological Disorders and Stroke [NINDS] U01NS095869): in-kind study drug from the Bristol-Myers Squibb (BMS)-Pfizer Alliance for Eliquis and ancillary study support from Roche Diagnostics; NIH Funding (R01NS29993; R01ES031808; 1UG3 NS119702); Royalties, UpToDate stroke chapter; Honoraria, lectures from the Atria Academy for Science and Medicine. Employment by American Heart Association. Dr Kamel: PI, ARCADIA trial (NIH/NINDS U01NS095869): in-kind study drug from BMS-Pfizer Alliance for Eliquis; Ancillary study support, Roche Diagnostics; NIH (R01HL144541, R01NS123576, U01NS106513); Deputy Editor, JAMA Neurology; Clinical trial steering/executive committees, Medtronic, Janssen, Javelin Medical; end point adjudication, AstraZeneca, Novo Nordisk, Boehringer Ingelheim; household ownership interests in TETMedical, Spectrum Plastics Group, Burke Porter Group. Compensation from American Medical Association for consultant services. Dr Saver provided study medication supplies for Novo Nordisk, Monies for drug shipping, temperature monitoring and after-hour enrollment for NINDS-funded FASTEST trial (rFVIIa for Acute Hemorrhagic Stroke Administered at Earliest Time), from neurology Department, receives monies to educational/research fund from Genentech for role on Executive Committee of Timeless Trial; Roche Pharmaceuticals, consulting; BrainsGate Ltd, consulting; Basking Biosciences, Kroger Prescription Plans Inc’s Pharmacy & Therapeutics Committee, voting committee member. Received compensation from Biogen for consultant services; compensation from Johnson & Johnson Health Care Systems Inc. for consultant services; compensation from Boehringer Ingelheim (prevention only) for consultant services; and compensation from Abbott Laboratories for consultant services.