Incidence of Previously Undiagnosed Atrial Fibrillation Using Insertable Cardiac Monitors in a High-Risk Population: The REVEAL AF Study.
James A. Reiffel,Atul Verma,Peter R. Kowey,Jonathan L. Halperin,Bernard J. Gersh,Rolf Wachter,Erika Pouliot,Paul D. Ziegler +7 more
TLDR
The incidence of previously undiagnosed AF may be substantial in patients with risk factors for AF and stroke and further trials regarding the value of detecting subclinical AF and of prophylactic therapies are warranted.Abstract:
Importance In approximately 20% of atrial fibrillation (AF)–related ischemic strokes, stroke is the first clinical manifestation of AF. Strategies are needed to identify and therapeutically address previously undetected AF. Objective To quantify the incidence of AF in patients at high risk for but without previously known AF using an insertable cardiac monitor. Design, Setting, and Participants This prospective, single-arm, multicenter study was conducted from November 2012 to January 2017. Visits took place at 57 centers in the United States and Europe. Patients with a CHADS 2 score of 3 or greater (or 2 with at least 1 additional risk factor) were enrolled. Approximately 90% had nonspecific symptoms potentially compatible with AF, such as fatigue, dyspnea, and/or palpitations. Exposures Patients underwent monitoring with an insertable cardiac monitor for 18 to 30 months. Main Outcomes and Measures The primary end point was adjudicated AF lasting 6 or more minutes and was assessed at 18 months. Other analyses included detection rates at points from 30 days to 30 months and among CHADS 2 score subgroups. Median time from insertion to detection and the percentage of patients subsequently prescribed oral anticoagulation therapy was also determined. Results A total of 446 patients were enrolled; 233 (52.2%) were male, and the mean (SD) age was 71.5 (9.9) years. A total of 385 patients (86.3%) received an insertable cardiac monitor, met the primary analysis cohort definition, and were observed for a mean (SD) period of 22.5 (7.7) months. The detection rate of AF lasting 6 or more minutes at 18 months was 29.3%. Detection rates at 30 days and 6, 12, 24, and 30 months were 6.2%, 20.4%, 27.1%, 33.6%, and 40.0%, respectively. At 18 months, AF incidence was similar among patients with CHADS 2 scores of 2 (24.7%; 95% CI, 17.3-31.4), 3 (32.7%; 95% CI, 23.8-40.7), and 4 or greater (31.7%; 95% CI, 22.0-40.3) ( P = .23). Median (interquartile) time from device insertion to first AF episode detection was 123 (41-330) days. Of patients meeting the primary end point, 13 (10.2%) had 1 or more episodes lasting 24 hours or longer, and oral anticoagulation therapy was prescribed for 72 patients (56.3%). Conclusions and Relevance The incidence of previously undiagnosed AF may be substantial in patients with risk factors for AF and stroke. Atrial fibrillation would have gone undetected in most patients had monitoring been limited to 30 days. Further trials regarding the value of detecting subclinical AF and of prophylactic therapies are warranted. Trial Registration clinicaltrials.gov Identifier:NCT01727297read more
Citations
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2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS).
Gerhard Hindricks,Tatjana S. Potpara,Nikolaos Dagres,Elena Arbelo,Jeroen J. Bax,Carina Blomström-Lundqvist,Giuseppe Boriani,Manuel Castellá,Gheorghe Andrei Dan,Polychronis Dilaveris,Laurent Fauchier,Gerasimos Filippatos,Jonathan M. Kalman,Jonathan M. Kalman,Mark La Meir,Deirdre A. Lane,Jean-Pierre Lebeau,Maddalena Lettino,G. Y. H. Lip,Fausto J. Pinto,G. Neil Thomas,Marco Valgimigli,Isabelle C. Van Gelder,Isabelle C. Van Gelder,Bart P. Van Putte,Caroline L Watkins +25 more
TL;DR: The content of these European Society of Cardiology (ESC) Guidelines has been published for personal and educational use only and no commercial use is authorized.
Journal ArticleDOI
Passive Detection of Atrial Fibrillation Using a Commercially Available Smartwatch.
Geoffrey H. Tison,Jose M. Sanchez,Brandon M. Ballinger,Avesh Singh,Jeffrey E. Olgin,Mark J. Pletcher,Eric Vittinghoff,Emily S. Lee,Shannon M Fan,Rachel A. Gladstone,Carlos Mikell,Nimit Sharad Sohoni,Johnson Hsieh,Gregory M. Marcus +13 more
TL;DR: This proof-of-concept study found that smartwatch photoplethysmography coupled with a deep neural network can passively detect AF but with some loss of sensitivity and specificity against a criterion-standard ECG.
Journal ArticleDOI
Effect of a Home-Based Wearable Continuous ECG Monitoring Patch on Detection of Undiagnosed Atrial Fibrillation: The mSToPS Randomized Clinical Trial
Steven R. Steinhubl,Jill Waalen,Alison M. Edwards,Lauren Ariniello,Rajesh R. Mehta,Gail S. Ebner,C Carter,Katie Baca-Motes,Elise Felicione,Troy C. Sarich,Eric J. Topol +10 more
TL;DR: Among individuals at high risk for AF, immediate monitoring with a home-based wearable ECG sensor patch, compared with delayed monitoring, resulted in a higher rate of AF diagnosis after 4 months.
Journal ArticleDOI
Rationale and design of a large-scale, app-based study to identify cardiac arrhythmias using a smartwatch: The Apple Heart Study.
Mintu P. Turakhia,Mintu P. Turakhia,Manisha Desai,Haley Hedlin,Amol Rajmane,Nisha Talati,Todd A. Ferris,Sumbul A Desai,Divya Nag,Mithun Patel,Peter R. Kowey,John S. Rumsfeld,Andrea M. Russo,Mellanie True Hills,Christopher B. Granger,Kenneth W. Mahaffey,Marco V Perez +16 more
TL;DR: The results of this trial will provide initial evidence for the ability of a smartwatch algorithm to identify pulse irregularity and variability which may reflect previously unknown AF.
Journal ArticleDOI
Searching for Atrial Fibrillation Poststroke: A White Paper of the AF-SCREEN International Collaboration
Renate B. Schnabel,Karl Georg Haeusler,Jeff S. Healey,Ben Freedman,Giuseppe Boriani,Johannes Brachmann,Axel Brandes,Alejandro Bustamante,Barbara Casadei,Harry J.G.M. Crijns,Wolfram Doehner,Gunnar Engström,Laurent Fauchier,Leif Friberg,David J. Gladstone,Taya V. Glotzer,Shinya Goto,Graeme J. Hankey,Joseph Harbison,FD Richard Hobbs,Linda S B Johnson,Hooman Kamel,Paulus Kirchhof,Eleni Korompoki,Derk W. Krieger,Gregory Y.H. Lip,Maja-Lisa Løchen,Georges H. Mairesse,Joan Montaner,Lis Neubeck,George Ntaios,Jonathan P. Piccini,Tatjana S. Potpara,Terence J. Quinn,James A. Reiffel,Antonio Luiz Pinho Ribeiro,Michiel Rienstra,Mårten Rosenqvist,Themistoclakis Sakis,Moritz F. Sinner,Jesper Hastrup Svendsen,Isabelle C. Van Gelder,Rolf Wachter,Tissa Wijeratne,Bernard Yan +44 more
TL;DR: Clinically diagnosed AF after a stroke or a transient ischemic attack is associated with significantly increased risk of recurrent stroke or systemic embolism, in particular, with additional stroke risk factors, and requires OAC rather than antiplatelet therapy.
References
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2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society
Craig T. January,L. Samuel Wann,Joseph S. Alpert,Hugh Calkins,Joaquin E. Cigarroa,Joseph C. Cleveland,Jamie B. Conti,Patrick T. Ellinor,Michael D. Ezekowitz,Michael E. Field,Katherine T. Murray,Ralph L. Sacco,William G. Stevenson,Patrick J. Tchou,Cynthia M. Tracy,Clyde W. Yancy +15 more
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Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the AnTicoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study.
Alan S. Go,Elaine M. Hylek,Kathleen A. Phillips,Yuchiao Chang,Lori E. Henault,Joe V. Selby,Daniel E. Singer +6 more
TL;DR: It is confirmed that atrial fibrillation is common among older adults and provides a contemporary basis for estimates of prevalence in the United States.
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2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS
Paulus Kirchhof,Stefano Benussi,Dipak Kotecha,Anders Ahlsson,Dan Atar,Barbara Casadei,Manuel Castellá,Hans-Christoph Diener,Hein Heidbuchel,Jeroen M.L. Hendriks,Gerhard Hindricks,Antonis S. Manolis,Jonas Oldgren,Bogdan A. Popescu,Ulrich Schotten,Bart P. Van Putte,Panagiotis Vardas,Stefan Agewall,John Camm,Gonzalo Barón Esquivias,Werner Budts,Scipione Carerj,Filip Casselman,Antonio Coca,Raffaele De Caterina,Spiridon Deftereos,Dobromir Dobrev,José M. Ferro,Gerasimos Filippatos,Donna Fitzsimons,Bulent Gorenek,Maxine Guenoun,Stefan H. Hohnloser,Philippe Kolh,Gregory Y.H. Lip,Athanasios J. Manolis,John J.V. McMurray,Piotr Ponikowski,Raphael Rosenhek,Frank Ruschitzka,Irina Savelieva,Sanjay Sharma,Piotr Suwalski,Juan Tamargo,Clare J Taylor,Isabelle C. Van Gelder,Adriaan A. Voors,Stephan Windecker,José Luis Zamorano,Katja Zeppenfeld +49 more
TL;DR: The Task Force for the management of atrial fibrillation of the European Society of Cardiology has been endorsed by the European Stroke Organisation (ESO).
Journal ArticleDOI
Worldwide Epidemiology of Atrial Fibrillation: A Global Burden of Disease 2010 Study
Sumeet S. Chugh,Rasmus Havmoeller,Kumar Narayanan,David Singh,Michiel Rienstra,Emelia J. Benjamin,Richard F. Gillum,Younghoon Kim,John H. McAnulty,Zhi Jie Zheng,Mohammad H. Forouzanfar,Mohsen Naghavi,George A. Mensah,Majid Ezzati,Christopher J L Murray +14 more
TL;DR: Evidence of progressive increases in overall burden, incidence, prevalence, and AF-associated mortality between 1990 and 2010 is provided, with significant public health implications.
Journal ArticleDOI
Executive Summary: Heart Disease and Stroke Statistics--2016 Update: A Report From the American Heart Association.
Dariush Mozaffarian,Emelia J. Benjamin,Alan S. Go,Donna K. Arnett,Michael J. Blaha,Mary Cushman,Sandeep R Das,Sarah D. de Ferranti,Jean-Pierre Després,Heather J. Fullerton,Virginia J. Howard,Mark D. Huffman,Carmen R. Isasi,Monik C. Jiménez,Suzanne E. Judd,Brett M. Kissela,Judith H. Lichtman,Lynda D. Lisabeth,Simin Liu,Rachel H. Mackey,David J. Magid,Darren K. McGuire,Emile R. Mohler,Claudia S. Moy,Paul Muntner,Michael E. Mussolino,Khurram Nasir,Robert W. Neumar,Graham Nichol,Latha Palaniappan,Dilip K. Pandey,Mathew J. Reeves,Carlos J. Rodriguez,Wayne D. Rosamond,Paul D. Sorlie,Joel M. Stein,Amytis Towfighi,Tanya N. Turan,Salim S. Virani,Daniel Woo,Robert W. Yeh,Melanie B. Turner +41 more
TL;DR: Author(s): Writing Group Members; Mozaffarian, Dariush; Benjamin, Emelia J; Go, Alan S; Arnett, Donna K; Blaha, Michael J; Cushman, Mary; Das, Sandeep R; de Ferranti, Sarah; Despres, Jean-Pierre; Fullerton, Heather J; Howard, Virginia J; Huffman, Mark D; Isasi, Carmen R; Jimenez, Monik C; Judd, Suzanne
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