@article{689b707a733d46e191e7ad7c6e7d8940,
title = "Proposal for Updated Nomenclature and Classification of Potential Causative Mechanism in Patent Foramen Ovale-Associated Stroke",
abstract = "Importance: Recent epidemiologic and therapeutic advances have transformed understanding of the role of and therapeutic approach to patent foramen ovale (PFO) in ischemic stroke. Patent foramen ovale is likely responsible for approximately 5% of all ischemic strokes and 10% of those occurring in young and middle-aged adults.Observations: Randomized clinical trials have demonstrated that, to prevent recurrent ischemic stroke in patients with PFO and an otherwise-cryptogenic index ischemic stroke, PFO closure is superior to antiplatelet medical therapy alone; these trials have provided some evidence that, among medical therapy options, anticoagulants may be more effective than antiplatelet agents.Conclusions and Relevance: These new data indicate a need to update classification schemes of causative mechanisms in stroke, developed in an era in which an association between PFO and stroke was viewed as uncertain. We propose a revised general nomenclature and classification framework for PFO-associated stroke and detailed revisions for the 3 major stroke subtyping algorithms in wide use. ",
author = "Tobis, {Jonathan M.} and Elgendy, {Akram Y.} and Saver, {Jeffrey L.} and Zahid Amin and Boudoulas, {Konstantinos Dean} and Carroll, {John D.} and Elgendy, {Islam Y.} and Grunwald, {Iris Q.} and Gertz, {Zachary M.} and Hijazi, {Ziyad M.} and Horlick, {Eric M.} and Kasner, {Scott E.} and Kent, {David M.} and Preetham Kumar and Kavinsky, {Clifford J.} and Liebeskind, {David S.} and Helmi Lutsep and Mojadidi, {Mohammad K.} and Mess{\'e}, {Steven R.} and Mas, {Jean Louis} and Mattle, {Heinrich P.} and Bernhard Meier and Ahmad Mahmoud and Mahmoud, {Ahmed N.} and Fabian Nietlispach and Patel, {Nimesh K.} and Rhodes, {John F.} and Mark Reisman and Sommer, {Robert J.} and Horst Sievert and Lars S{\o}ndergaard and Zaman, {Muhammad O.} and David Thaler",
note = "Funding Information: received contracted hourly payments and travel reimbursement for service as a scientific consultant advising on rigorous trial design and conduct to Abbott and Boehringer Ingelheim. For Dr Saver{\textquoteright}s work, the University of California Regents received payments on the basis of clinical trial contracts for the number of participants enrolled in multicenter clinical trials from Abbott and Boehringer Ingelhim; Dr Saver served as an unpaid site investigator under these contracts. Dr Amin serves as a consultant and member of the advisory board for Abbott. Dr Carroll has served on the Steering Committee of the RESPECT trial with payment for his services to his institution and was a local investigator for the REDUCE trial; Dr Carroll reports personal fees from Abbott Vascular and nonfinancial support from Gore during the conduct of the study and nonfinancial support from Edwards Lifesciences, personal fees from Abbott Vascular, and nonfinancial support from Medtronic outside the submitted work. Dr Hijazi owns stock options in Occlutech, a company that makes a patent foramen ovale closure device. Dr Horlick is a consultant for Abbott, Edwards, and Medtronic and receives research grants and nonfinancial support from Abbott; Dr Horlick also reports nonfinancial support from Occlutech and grants from Gore outside the submitted work. Dr Kasner reports grants from WL Gore and Associates during the conduct of the study and grants from Bayer and Bristol-Myers Squibb outside the submitted work. Dr Kent reports personal fees from Biogen outside the submitted work. Dr Kasner receives research support from WL Gore. Dr Lutsep has served as a consultant for Abbott, and as a site primary Investigator of the RESPECT trial and on the Neurology Executive Committee for the RESPECT trial. Dr Mess{\'e} served as the site primary investigator for the REDUCE trial and reports grants from WL Gore outside the submitted work. Drs Mattle and Meier have received speaker fees from Abbott and served as co–principal investigators of the PC and PRIMA trials. Dr Mattle also reports grants and personal fees from Cerenovus; personal fees from Bayer, Servier, and Medtronic; and grants from Abbott outside the submitted work. Dr Meier reports personal fees from Abbott during the conduct of the study. Dr Nietlispach has served as a consultant for Edwards Lifesciences, Abbott, and Medtronic. Dr Rhodes reports personal fees from WL Gore during the conduct of the study. Dr Sommer served as a co–principal investigator of the REDUCE trial, and he served as a national primary investigator for the ESCAPE Migraine trial sponsored by St Jude Medical; he also received an Investigator-Initiated Grant from AstraZeneca to fund the TRACTOR Migraine Trial and reports a patent to 18-50039-US-PV (501038.20704) pending and serving as a national principal investigator to the RELIEF Migraine-PFO Trial (sponsored by WL Gore & Associates). Dr Sievert has served as a consultant for 4tech Cardio, Abbott, Ablative Solutions, Ancora Heart, Bavaria Medizin Technologie GmbH, Bioventrix, Boston Scientific, Carag, Cardiac Dimensions, Celonova, Comed BV, Contego, CVRx, Dinova, Edwards, Endologix, Hangzhou Nuomao Medtech, Hemoteq, Holistick Medical, K2, Lifetech, Maquet Getinge Group, Medtronic, Mitralign, Mokita, Nuomao Medtech, Mokita, Occlutech, pfm Medical, Recor, Renal Guard, Rox Medical, Terumo, Vascular Dynamics, Venus, Venock, and Vivasure Medical. Dr Sondergaard has received consultant fees and institutional research grants from Abbott and WL Gore. Dr Thaler reports personal fees from Abbott Laboratories for serving on a steering committee. Dr Tobis has served as a consultant for Abbott and WL Gore, as a co-investigator of the RESPECT trial, on the Steering committee of the PREMIUM trial, and as a proctor for Cardiac Dimensions. No other disclosures were reported. Publisher Copyright: {\textcopyright} 2020 American Medical Association. All rights reserved. Copyright: Copyright 2020 Elsevier B.V., All rights reserved.",
year = "2020",
month = jul,
day = "1",
doi = "10.1001/jamaneurol.2020.0458",
language = "English",
volume = "77",
pages = "878--886",
journal = "JAMA Neurology",
issn = "2168-6149",
publisher = "American Medical Association",
number = "7",
}
