Accuracy of Apple Watch for Detection of Atrial Fibrillation
2020; Lippincott Williams & Wilkins; Volume: 141; Issue: 8 Linguagem: Inglês
10.1161/circulationaha.119.044126
ISSN1524-4539
AutoresDhruv R. Seshadri, Barbara Bittel, Dalton Browsky, Penny L. Houghtaling, Colin K. Drummond, Milind Y. Desai, A. Marc Gillinov,
Tópico(s)ECG Monitoring and Analysis
ResumoHomeCirculationVol. 141, No. 8Accuracy of Apple Watch for Detection of Atrial Fibrillation Free AccessLetterPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessLetterPDF/EPUBAccuracy of Apple Watch for Detection of Atrial Fibrillation Dhruv R. Seshadri, MS, Barbara Bittel, BSN, RN, CCRP, Dalton Browsky, BS, Penny Houghtaling, MS, Colin K. Drummond, PhD, Milind Y. Desai, MD and A. Marc Gillinov, MD Dhruv R. SeshadriDhruv R. Seshadri Department of Biomedical Engineering, Case Western Reserve University, Cleveland, OH (D.R.S., C.K.D.). Search for more papers by this author , Barbara BittelBarbara Bittel The Heart and Vascular Institute, Cleveland Clinic, OH (B.B., D.B., P.H., M.Y.D., A.M.G.). Search for more papers by this author , Dalton BrowskyDalton Browsky The Heart and Vascular Institute, Cleveland Clinic, OH (B.B., D.B., P.H., M.Y.D., A.M.G.). Search for more papers by this author , Penny HoughtalingPenny Houghtaling The Heart and Vascular Institute, Cleveland Clinic, OH (B.B., D.B., P.H., M.Y.D., A.M.G.). Search for more papers by this author , Colin K. DrummondColin K. Drummond Department of Biomedical Engineering, Case Western Reserve University, Cleveland, OH (D.R.S., C.K.D.). Search for more papers by this author , Milind Y. DesaiMilind Y. Desai The Heart and Vascular Institute, Cleveland Clinic, OH (B.B., D.B., P.H., M.Y.D., A.M.G.). Search for more papers by this author and A. Marc GillinovA. Marc Gillinov A. Marc Gillinov, MD, Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic/Desk J4-1, Cleveland, OH 44195. Email E-mail Address: [email protected] The Heart and Vascular Institute, Cleveland Clinic, OH (B.B., D.B., P.H., M.Y.D., A.M.G.). Search for more papers by this author Originally published24 Feb 2020https://doi.org/10.1161/CIRCULATIONAHA.119.044126Circulation. 2020;141:702–703In the Apple Heart Study, 34% of individuals who received a notification of arrhythmia were later found to have atrial fibrillation (AF), and the positive predictive value in participants notified of an irregular pulse was 0.84.1 That study relied on optical sensors in Apple Watch Series 1 through 3 to detect an irregular pulse and a proprietary algorithm to indicate arrhythmia.1 In contrast, the Apple Watch Series 4 (AW4) uses electrodes to generate a single-lead ECG and provides 2 mechanisms for rhythm assessment: rhythm notification (AF, sinus rhythm [SR], or inconclusive) and single-lead ECG downloaded as a PDF for interpretation.2 This study assessed the accuracy of the AW4 for AF detection in patients who had undergone cardiac surgery, a group who frequently cycle between AF and SR.MethodsWe recruited 50 patients who had undergone cardiac surgery who were on telemetry. Exclusion criteria included cardiac pacemaker, surgical use of a radial artery, chronic heart rhythm abnormalities, and wrist tattoos. The protocol was approved by the institutional review board and registered at ClinicalTrials.gov (NCT03798613). Subjects provided written informed consent.Rhythm assessments were performed 3 times per day (morning, early/late afternoon, and early/late evening) over 2 days, resulting in 6 assessments per patient. At each assessment, the subject was randomly assigned by computer program 1 of 5 AW4 watches that was placed on a wrist (randomly assigned); 5 watches were purchased to mitigate the impact of possible hardware malfunctions and the potential impact of a single device. When instructed, subjects depressed the crown for 30 seconds, and the watch reading (SR, AF, inconclusive) was recorded. Simultaneously, a PDF of the waveform on the Apple Health App and a rhythm strip from telemetry were saved and adjudicated by a cardiologist blinded to the patient’s telemetry rhythm. ECGs were generated and viewed according to instructions provided by Apple.2 The Cohen κ statistic was used to measure agreement between the AW4 notification and telemetry and between the AW4 ECG interpretation and telemetry. The sensitivity and specificity in detecting AF were calculated from generalized estimating equations with an exchangeable correlation matrix accounting for repeated measurements.3 Statistical analyses were performed with R and SAS statistical software (SAS version 9.4; SAS Institute Inc, Cary, NC).ResultsOf 300 possible rhythm assessments, 292 were obtained; 2 patients were discharged before study completion, and 1 patient withdrew consent. On telemetry, AF was observed in 90 instances, and SR was seen in 202; 25 of 50 patients had ≥1 episodes of AF.The AW4 notification correctly identified AF in 34 of 90 instances, yielding a sensitivity of 41% (Table). Of 25 patients with at least 1 episode of AF, AF was identified in 19. Among patients in SR, none was designated as AF (ie, no false positives); however, rhythm was deemed inconclusive in 31% of patients, and there was no additional attempt to assess rhythm. Overall agreement between AW4 notification and telemetry was 61% (κ statistic = 0.33 [95% CI, 0.24–0.41]).Table. Rhythm Detection by the AW4 in 90 Instances of Telemetry-Confirmed AFAF, n (%)SR, n (%)Inconclusive, n (%)No Reading, n (%)Sensitivity, %Specificity, %Apple Watch notification/display34 (38)27 (30)29 (32)0 (0)41100Apple Watch PDF interpretation84 (93)0 (0)0 (0)6 (7)96100AF indicates atrial fibrillation; AW4, Apple Watch 4; and SR, sinus rhythm.Rhythm was assessed with the Apple Watch 4 in 2 distinct fashions: notification/display on the watch face and offline interpretation of the PDF of the rhythm waveform stored by the Apple Heart App.The AW4 generated a retrievable PDF of the ECG waveform in 284 of 292 rhythm assessments; in 8 instances, the AW4 and associated app failed to generate a PDF, and these missing data were treated as incorrect rhythm interpretations. Of 90 instances of AF, the PDF waveform demonstrated AF in 84 (96% sensitivity). In 25 patients with at least 1 episode of AF, AF was identified in 24. Among patients in SR, none was designated as AF (no false positives); however, rhythm was deemed inconclusive in 2 because no PDF of the waveform was generated (Table). Overall, agreement between the Apple Watch–generated PDF rhythm strips and telemetry was 98.9% (κ statistic = 0.98 [95% CI, 0.96–1.0]).DiscussionThis study evaluated the accuracy of the AW4 to detect AF in cardiac patients. The AW4 provides 2 mechanisms for rhythm assessment: a notification/display on the watch and a downloadable waveform on PDF. The display on the watch did not provide notification of AF in a significant proportion of instances; however, it generated no false-positive reports of AF. The limited number of rhythm assessments in this study precluded identification of factors associated with failure to generate AF notifications. The saved PDF waveform enabled accurate determination of heart rhythm, whether AF or SR. The single-lead electrocardiographic waveform saved as a PDF provided a more reliable means of detecting AF than the rhythm notification of the watch.In Apple’s internal study of 588 subjects, the algorithm that classified ECGs as SR, AF, or inconclusive demonstrated >98% sensitivity and >99% specificity.4 The unreadable (ie, inconclusive) rate reported in that study was 6% compared with 31% in this pilot study. Variations in sensitivity between these 2 studies suggest the need for further validation before this technology is adopted by the public for AF detection. Physicians should exercise caution before undertaking action based on electrocardiographic diagnoses generated by this wrist-worn monitor.Sources of FundingFunding was provided by the Mary Elizabeth Holdsworth Fund at Cleveland Clinic.DisclosuresNone.FootnotesThe data that support the findings of this study are available from the corresponding author on reasonable request.https://www.ahajournals.org/journal/circA. Marc Gillinov, MD, Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic/Desk J4-1, Cleveland, OH 44195. Email [email protected]orgReferences1. Perez MV, Mahaffey KW, Hedlin H, Rumsfeld JS, Garcia A, Ferris T, Balasubramanian V, Russo AM, Rajmane A, Cheung L, et al; Apple Heart Study Investigators. Large-scale assessment of a smartwatch to identify atrial fibrillation.N Engl J Med. 2019; 381:1909–1917. doi: 10.1056/NEJMoa1901183CrossrefMedlineGoogle Scholar2. Apple Support. Taking an ECG with the ECG app on Apple Watch Series 4.November 18, 2019. https://support.apple.com/en-us/HT208955. Accessed May 7, 2019.Google Scholar3. Genders TS, Spronk S, Stijnen T, Steyerberg EW, Lesaffre E, Hunink MG. Methods for calculating sensitivity and specificity of clustered data: a tutorial.Radiology. 2012; 265:910–916. doi: 10.1148/radiol.12120509CrossrefMedlineGoogle Scholar4. Apple Inc. 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February 25, 2020Vol 141, Issue 8 Advertisement Article InformationMetrics © 2020 American Heart Association, Inc.https://doi.org/10.1161/CIRCULATIONAHA.119.044126PMID: 32091929 Originally publishedFebruary 24, 2020 Keywordsatrial fibrillationPDF download Advertisement SubjectsAtrial FibrillationLifestyle
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