Screening for Atrial Fibrillation in Older Adults at Primary Care Visits: VITAL-AF Randomized Controlled Trial
Abstract
Background:
Undiagnosed atrial fibrillation (AF) may cause preventable strokes. Guidelines differ regarding AF screening recommendations. We tested whether point-of-care screening with a handheld single-lead ECG at primary care practice visits increases diagnoses of AF.
Methods:
We randomized 16 primary care clinics 1:1 to AF screening using a handheld single-lead ECG (AliveCor KardiaMobile) during vital sign assessments, or usual care. Patients included were ages ≥65 years. Screening results were provided to primary care clinicians at the encounter. All confirmatory diagnostic testing and treatment decisions were made by the primary care clinician. New AF diagnoses during the 1-year follow-up were ascertained electronically and manually adjudicated. Proportions and incidence rates were calculated. Effect heterogeneity was assessed.
Results:
Of 30 715 patients without prevalent AF (n=15 393 screening [91% screened], n=15 322 control), 1.72% of individuals in the screening group had new AF diagnosed at 1 year versus 1.59% in the control group (risk difference, 0.13% [95% CI, –0.16 to 0.42]; P=0.38). In prespecified subgroup analyses, new AF diagnoses in the screening and control groups were greater among those aged ≥85 years (5.56% versus 3.76%, respectively; risk difference, 1.80% [95% CI, 0.18 to 3.30]). The difference in newly diagnosed AF between the screening period and the previous year was marginally greater in the screening versus control group (0.32% versus –0.12%; risk difference, 0.43% [95% CI, –0.01 to 0.84]). The proportion of individuals with newly diagnosed AF who were initiated on oral anticoagulants was not different in the screening (n=194, 73.5%) and control (n=172, 70.8%) arms (risk difference, 2.7% [95% CI, –5.5 to 10.4]).
Conclusions:
Screening for AF using a single-lead ECG at primary care visits did not affect new AF diagnoses among all individuals aged 65 years or older compared with usual care.
Registration:
URL: https://www.clinicaltrials.gov; Unique identifier: NCT03515057.
Footnotes
References
- 1.
Wolf PA, Abbott RD, Kannel WB . Atrial fibrillation as an independent risk factor for stroke: the Framingham Study.Stroke. 1991; 22:983–988. doi: 10.1161/01.str.22.8.983LinkGoogle Scholar - 2.
Hart RG, Pearce LA, Aguilar MI . Meta-analysis: antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation.Ann Intern Med. 2007; 146:857–867. doi: 10.7326/0003-4819-146-12-200706190-00007CrossrefMedlineGoogle Scholar - 3.
Healey JS, Connolly SJ, Gold MR, Israel CW, Van Gelder IC, Capucci A, Lau CP, Fain E, Yang S, Bailleul C, ; ASSERT Investigators. Subclinical atrial fibrillation and the risk of stroke.N Engl J Med. 2012; 366:120–129. doi: 10.1056/NEJMoa1105575CrossrefMedlineGoogle Scholar - 4.
Lubitz SA, Yin X, McManus DD, Weng LC, Aparicio HJ, Walkey AJ, Rafael Romero J, Kase CS, Ellinor PT, Wolf PA, . Stroke as the initial manifestation of atrial fibrillation: the Framingham Heart Study.Stroke. 2017; 48:490–492. doi: 10.1161/STROKEAHA.116.015071LinkGoogle Scholar - 5.
Borowsky LH, Regan S, Chang Y, Ayres A, Greenberg SM, Singer DE . First diagnosis of atrial fibrillation at the time of stroke.Cerebrovasc Dis. 2017; 43:192–199. doi: 10.1159/000457809CrossrefMedlineGoogle Scholar - 6.
Engdahl J, Andersson L, Mirskaya M, Rosenqvist M . Stepwise screening of atrial fibrillation in a 75-year-old population: implications for stroke prevention.Circulation. 2013; 127:930–937. doi: 10.1161/CIRCULATIONAHA.112.126656LinkGoogle Scholar - 7.
Lowres N, Neubeck L, Salkeld G, Krass I, McLachlan AJ, Redfern J, Bennett AA, Briffa T, Bauman A, Martinez C, . Feasibility and cost-effectiveness of stroke prevention through community screening for atrial fibrillation using iPhone ECG in pharmacies. The SEARCH-AF study.Thromb Haemost. 2014; 111:1167–1176. doi: 10.1160/TH14-03-0231CrossrefMedlineGoogle Scholar - 8.
Svennberg E, Engdahl J, Al-Khalili F, Friberg L, Frykman V, Rosenqvist M . Mass screening for untreated atrial fibrillation: the STROKESTOP study.Circulation. 2015; 131:2176–2184. doi: 10.1161/CIRCULATIONAHA.114.014343LinkGoogle Scholar - 9.
Kaasenbrood F, Hollander M, Rutten FH, Gerhards LJ, Hoes AW, Tieleman RG . Yield of screening for atrial fibrillation in primary care with a hand-held, single-lead electrocardiogram device during influenza vaccination.Europace. 2016; 18:1514–1520. doi: 10.1093/europace/euv426CrossrefMedlineGoogle Scholar - 10.
Chan NY, Choy CC . Screening for atrial fibrillation in 13 122 Hong Kong citizens with smartphone electrocardiogram.Heart. 2017; 103:24–31. doi: 10.1136/heartjnl-2016-309993CrossrefMedlineGoogle Scholar - 11.
Chan PH, Wong CK, Pun L, Wong YF, Wong MM, Chu DW, Siu CW . Head-to-head comparison of the AliveCor Heart Monitor and Microlife WatchBP Office AFIB for atrial fibrillation screening in a primary care setting.Circulation. 2017; 135:110–112. doi: 10.1161/CIRCULATIONAHA.116.024439LinkGoogle Scholar - 12.
Kemp Gudmundsdottir K, Fredriksson T, Svennberg E, Al-Khalili F, Friberg L, Frykman V, Hijazi Z, Rosenqvist M, Engdahl J . Stepwise mass screening for atrial fibrillation using N-terminal B-type natriuretic peptide: the STROKESTOP II study.Europace. 2020; 22:24–32. doi: 10.1093/europace/euz255CrossrefMedlineGoogle Scholar - 13.
Fitzmaurice DA, Hobbs FD, Jowett S, Mant J, Murray ET, Holder R, Raftery JP, Bryan S, Davies M, Lip GY, . Screening versus routine practice in detection of atrial fibrillation in patients aged 65 or over: cluster randomised controlled trial.BMJ. 2007; 335:383. doi: 10.1136/bmj.39280.660567.55CrossrefMedlineGoogle Scholar - 14.
Kaasenbrood F, Hollander M, de Bruijn SH, Dolmans CP, Tieleman RG, Hoes AW, Rutten FH . Opportunistic screening versus usual care for diagnosing atrial fibrillation in general practice: a cluster randomised controlled trial.Br J Gen Pract. 2020; 70:e427–e433. doi: 10.3399/bjgp20X708161CrossrefMedlineGoogle Scholar - 15.
Uittenbogaart SB, Verbiest-van Gurp N, Lucassen WAM, Winkens B, Nielen M, Erkens PMG, Knottnerus JA, van Weert HCPM, Stoffers HEJH . Opportunistic screening versus usual care for detection of atrial fibrillation in primary care: cluster randomised controlled trial.BMJ. 2020; 370:m3208. doi: 10.1136/bmj.m3208CrossrefMedlineGoogle Scholar - 16.
Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomström-Lundqvist C, Boriani G, Castella M, Dan GA, Dilaveris PE, ; ESC Scientific Document Group. 2020 ESC guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): the task force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC.Eur Heart J. 2021; 42:373–498. doi: 10.1093/eurheartj/ehaa612CrossrefMedlineGoogle Scholar - 17.
NHFA CSANZ Atrial Fibrillation Guideline Working Group; Brieger D, Amerana J, Attia J, Bajorek B, Chan KH, Connell C, Freedman B, Ferguson C, Hall T, Haqqani H, . National Heart Foundation of Australia and the Cardiac Society of Australia and New Zealand: Australian clinical guidelines for the diagnosis and management of atrial fibrillation 2018.Heart Lung Circ. 2018; 27:1209–1266. doi: 10.1016/j.hlc.2018.06.1043CrossrefMedlineGoogle Scholar - 18.
US Preventive Services Task Force; Curry SJ, Krist AH, Owens DK, Barry MJ, Caughey AB, Davidson KW, Doubeni CA, Epling JW, Kemper AR, Kubik M, . Screening for atrial fibrillation with electrocardiography: US Preventive Services Task Force recommendation statement.JAMA. 2018; 320:478–484. doi: 10.1001/jama.2018.10321CrossrefMedlineGoogle Scholar - 19.
Ashburner JM, Atlas SJ, McManus DD, Chang Y, Trisini Lipsanopoulos AT, Borowsky LH, Guan W, He W, Ellinor PT, Singer DE, . Design and rationale of a pragmatic trial integrating routine screening for atrial fibrillation at primary care visits: the VITAL-AF trial.Am Heart J. 2019; 215:147–156. doi: 10.1016/j.ahj.2019.06.011CrossrefMedlineGoogle Scholar - 20.
Ivers NM, Halperin IJ, Barnsley J, Grimshaw JM, Shah BR, Tu K, Upshur R, Zwarenstein M . Allocation techniques for balance at baseline in cluster randomized trials: a methodological review.Trials. 2012; 13:120. doi: 10.1186/1745-6215-13-120CrossrefMedlineGoogle Scholar - 21.
Basu P, Small DS . Constructing a more closely matched control group in a difference-in-differences analysis: its effect on history interacting with group bias.Obs Stud2020; 6:103–130. doi: 10.1596/978-1-4648-0779-4Google Scholar - 22.
Gertler PJ, Martinez S, Premand P, Rawlings LB, Vermeersch CMJ . Impact Evaluation in Practice. 2nd ed. Washington, DC: International Bank for Reconstruction and Development/The World Bank; 2016.CrossrefGoogle Scholar - 23.
Nalichowski R, Keogh D, Chueh HC, Murphy SN . Calculating the benefits of a Research Patient Data Repository.AMIA Annual Symposium Proceedings/AMIA Symposium AMIA Symposium. 2006:1044.Google Scholar - 24.
Ashburner JM, Singer DE, Lubitz SA, Borowsky LH, Atlas SJ . Changes in use of anticoagulation in patients with atrial fibrillation within a primary care network associated with the introduction of direct oral anticoagulants.Am J Cardiol. 2017; 120:786–791. doi: 10.1016/j.amjcard.2017.05.055CrossrefMedlineGoogle Scholar - 25.
Pedroza C, Truong VT . Performance of models for estimating absolute risk difference in multicenter trials with binary outcome.BMC Med Res Methodol. 2016; 16:113. doi: 10.1186/s12874-016-0217-0CrossrefMedlineGoogle Scholar - 26.
Alonso A, Krijthe BP, Aspelund T, Stepas KA, Pencina MJ, Moser CB, Sinner MF, Sotoodehnia N, Fontes JD, Janssens AC, . Simple risk model predicts incidence of atrial fibrillation in a racially and geographically diverse population: the CHARGE-AF consortium.J Am Heart Assoc. 2013; 2:e000102. doi: 10.1161/JAHA.112.000102LinkGoogle Scholar - 27.
Hemming K, Girling AJ, Sitch AJ, Marsh J, Lilford RJ . Sample size calculations for cluster randomised controlled trials with a fixed number of clusters.BMC Med Res Methodol. 2011; 11:102. doi: 10.1186/1471-2288-11-102CrossrefMedlineGoogle Scholar - 28.
Lowres N, Olivier J, Chao TF, Chen SA, Chen Y, Diederichsen A, Fitzmaurice DA, Gomez-Doblas JJ, Harbison J, Healey JS, . Estimated stroke risk, yield, and number needed to screen for atrial fibrillation detected through single time screening: a multicountry patient-level meta-analysis of 141,220 screened individuals.PLoS Med. 2019; 16:e1002903. doi: 10.1371/journal.pmed.1002903CrossrefMedlineGoogle Scholar - 29.
Lip GY, Nieuwlaat R, Pisters R, Lane DA, Crijns HJ . Refining clinical risk stratification for predicting stroke and thromboembolism in atrial fibrillation using a novel risk factor-based approach: the Euro Heart Survey on Atrial Fibrillation.Chest. 2010; 137:263–272. doi: 10.1378/chest.09-1584CrossrefMedlineGoogle Scholar - 30.
Marzec LN, Wang J, Shah ND, Chan PS, Ting HH, Gosch KL, Hsu JC, Maddox TM . Influence of direct oral anticoagulants on rates of oral anticoagulation for atrial fibrillation.J Am Coll Cardiol. 2017; 69:2475–2484. doi: 10.1016/j.jacc.2017.03.540CrossrefMedlineGoogle Scholar - 31.
Svennberg E, Friberg L, Frykman V, Al-Khalili F, Engdahl J, Rosenqvist M . Clinical outcomes in systematic screening for atrial fibrillation (STROKESTOP): a multicentre, parallel group, unmasked, randomised controlled trial.Lancet. 2021; 398:1498–1506. doi: 10.1016/S0140-6736(21)01637-8CrossrefMedlineGoogle Scholar - 32.
January CT, Wann LS, Calkins H, Chen LY, Cigarroa JE, Cleveland JC, Ellinor PT, Ezekowitz MD, Field ME, Furie KL, . 2019 AHA/ACC/HRS focused update of the 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 Clinical Practice Guidelines and the Heart Rhythm Society in collaboration with the Society of Thoracic Surgeons.Circulation. 2019; 140:e125–e151. doi: 10.1161/CIR.0000000000000665LinkGoogle Scholar - 33.
Steinhubl SR, Waalen J, Edwards AM, Ariniello LM, Mehta RR, Ebner GS, Carter C, Baca-Motes K, Felicione E, Sarich T, . Effect of a home-based wearable continuous ECG monitoring patch on detection of undiagnosed atrial fibrillation: the mSToPS randomized clinical trial.JAMA. 2018; 320:146–155. doi: 10.1001/jama.2018.8102CrossrefMedlineGoogle Scholar - 34.
Go AS, Reynolds K, Yang J, Gupta N, Lenane J, Sung SH, Harrison TN, Liu TI, Solomon MD . Association of burden of atrial fibrillation with risk of ischemic stroke in adults with paroxysmal atrial fibrillation: the KP-RHYTHM study.JAMA Cardiol. 2018; 3:601–608. doi: 10.1001/jamacardio.2018.1176CrossrefMedlineGoogle Scholar - 35. National Institutes of Health. US National Library of Medicine. ClinicalTrials.gov. A Study to Determine if Identification of Undiagnosed Atrial Fibrillation in People at Least 70 Years of Age Reduces the Risk of Stroke (GUARD-AF).Updated November 19, 2020. https://clinicaltrials.gov/ct2/show/NCT04126486. Accessed January 23, 2021.Google Scholar
- 36. University of Cambridge. The Safer Trial - Screening for Atrial Fibrillation with ECG to Reduce Stroke.2020. https://www.safer.phpc.cam.ac.uk. Accessed January 23, 2021.Google Scholar
- 37.
Lopes RD, Alings M, Connolly SJ, Beresh H, Granger CB, Mazuecos JB, Boriani G, Nielsen JC, Conen D, Hohnloser SH, . Rationale and design of the Apixaban for the Reduction of Thrombo-Embolism in Patients With Device-Detected Sub-Clinical Atrial Fibrillation (ARTESiA) trial.Am Heart J. 2017; 189:137–145. doi: 10.1016/j.ahj.2017.04.008CrossrefMedlineGoogle Scholar - 38.
Kirchhof P, Blank BF, Calvert M, Camm AJ, Chlouverakis G, Diener HC, Goette A, Huening A, Lip GYH, Simantirakis E, . Probing oral anticoagulation in patients with atrial high rate episodes: rationale and design of the Non-Vitamin K Antagonist Oral Anticoagulants in Patients With Atrial High Rate Episodes (NOAH-AFNET 6) trial.Am Heart J. 2017; 190:12–18. doi: 10.1016/j.ahj.2017.04.015CrossrefMedlineGoogle Scholar


