Wearing Your Heart on Your Sleeve: the Future of Cardiac Rhythm Monitoring
- 44 Downloads
Purpose of Review
This review describes the novel category of wearable ECG monitors and identifies where patients, healthcare providers, and device manufacturers should focus efforts to maximize the clinical benefit of these devices.
Notable wearable ECG monitors include the AliveCor Kardia devices, Apple Watch Series 4, and several others. The most common use case is monitoring for atrial fibrillation. The available evidence validates the ability of the Kardia devices and Apple Watch to distinguish atrial fibrillation from sinus rhythm. Key questions for manufacturers include how to calibrate each device’s algorithms and streamline workflows for healthcare providers.
Wearable ECG monitors are currently most useful to detect atrial fibrillation. Further study is needed to demonstrate whether wearable ECG monitors improve patient outcomes, and to expand their use into other indications. Device manufacturers and healthcare providers must work together to establish new workflows to process and act on wearable ECG data.
KeywordsAtrial fibrillation Stroke Wearables Electrocardiogram Apple Watch AliveCor
We are grateful to Daniel B. Kramer, MD, MPH, for critical review of the manuscript.
David McManus is supported by NIH grants R01HL126911, R01HL137734, R01HL137794, R01HL13660, R01HL141434, and U54HL143541.
Steven A. Lubitz is supported by NIH grant 1R01HL139731 and American Heart Association 18SFRN34250007.
Eric Ding is supported by a grant from the National Heart, Lung, Blood Institute (Grant #5T32HL120823).
Compliance with Ethical Standards
Conflict of Interest
Mostafa A. Al-Alusi and Eric Ding declare that they have no conflict of interest.
David McManus has received research support from Apple Computer, Bristol-Myers Squibb, Boehringher-Ingelheim, Flexcon, Fitbit Heart Rhythm Society, Pfizer, Samsung, Philips Healthcare, Biotronik, and has received consultancy fees or honoraria from Bristol-Myers Squibb, Pfizer, Flexcon, Boston Biomedical Associates, Samsung, and Rose Consulting.
Steven A. Lubitz receives sponsored research support from Bristol Myers Squibb / Pfizer, Bayer AG, and Boehringer Ingelheim, and has consulted for Bristol Myers Squibb / Pfizer and Bayer AG.
Human and Animal Rights and Informed Consent
This article does not contain any studies with human or animal subjects performed by any of the authors.
Papers of particular interest, published recently, have been highlighted as: • Of importance •• Of major importance
- 1.Gates B, Myhrvold N, Rinearson P. The road ahead: Viking Press; 1995.Google Scholar
- 2.Apple Watch Series 4 Health [Internet]. Apple. [cited 2019 May 2]. Available from: https://www.apple.com/apple-watch-series-4/health/.
- 3.KardiaBand [Internet]. AliveCor. [cited 2019 May 2]. Available from: https://store.alivecor.com/products/kardiaband.
- 4.KardiaMobile [Internet]. AliveCor. [cited 2019 May 2]. Available from: https://store.alivecor.com/products/kardiamobile.
- 5.QardioCore [Internet]. GetQardio [cited 2019 May 2]. Available from: https://www.getqardio.com/qardiocore-wearable-ecg-ekg-monitor-iphone/.
- 6.Hexoskin [Internet]. Hexoskin. [cited 2019 May 2]. Available from: https://www.hexoskin.com.
- 7.Withings Move ECG [Internet]. Withings. [cited 2019 May 2]. Available from: https://www.withings.com/us/en/move-ecg?gclid=EAIaIQobChMI6-ju_7_94QIVg0wNCh1ghQKnEAAYASAAEgLzRfD_BwEgclsrc=aw.ds.
- 8.Introducing Verily Study Watch [Internet]. Verily Blog. 2017 [cited 2019 May 16]. Available from: https://blog.verily.com/2017/04/introducing-verily-study-watch.html.
- 9.New Health Band Takes ECG Tracking to Heart [Internet]. Amazfit Blog. 2017 [cited 2019 May 2]. Available from: https://us.amazfit.com/blog/health-band.
- 10.KardiaAI 510(k) Notification K181823 [Internet]. Food and Drug Administration; 2019 [cited 2019 Jun 15]. Available from: https://www.accessdata.fda.gov/cdrh_docs/pdf18/K181823.pdf.
- 11.Kardia Band System 510(k) Notification K171816 [Internet]. Food and Drug Administration; 2017 [cited 2019 Jun 15]. Available from: https://www.accessdata.fda.gov/cdrh_docs/pdf17/K171816.pdf.
- 12.AliveCor Heart Monitor 510(k) Premarket Notification K142743 [Internet]. Food and Drug Administration; 2014 [cited 2019 Jun 15]. Available from: https://www.accessdata.fda.gov/cdrh_docs/pdf14/K142743.pdf.
- 13.De Novo classification request for ECG App DEN180044 [Internet]. Food and Drug Administration; 2018 [cited 2019 May 27]. Available from: https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN180044.pdf.
- 14.De Novo classification request for irregular rhythm notification feature DEN180042 [Internet]. Food and Drug Administration; 2018 [cited 2019 May 27]. Available from: https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN180042.pdf.
- 15.KardiaMobile 6L [Internet]. AliveCor. [cited 2019 May 20]. Available from: https://www.alivecor.com/kardiamobile6l/.
- 16.CALM-M for healthcare [Internet]. CALM Health. [cited 2019 May 16]. Available from: https://www.calm-health.com/calm-healthcare/.
- 17.HeartBit - technology [Internet]. HeartBit. [cited 2019 May 16]. Available from: https://theheartbit.com/technology/.
- 18.Revolutionary solution for exercise ECG detection [Internet]. Heartbit; 2018 [cited 2019 Jun 15]. Available from: https://drive.google.com/drive/folders/1TtJqy593UTSGUXS7UFETNgrFh1SiXC4e.
- 19.Study Watch Traditional 510(k) Premarket Notification K182456 [Internet]. Food and Drug Administration; 2019 [cited 2019 May 26]. Available from: http://www.accessdata.fda.gov/cdrh_docs/pdf18/K182456.pdf.
- 20.Triangle System 510(k) Premarket notification K142743 [Internet]. Food and Drug Administration; 2019 [cited 2019 Jun 15]. Available from: https://www.accessdata.fda.gov/cdrh_docs/pdf18/K183319.pdf.
- 21.Christensen CM. The innovators dilemma: when new technologies cause great firms to fail: Harvard Business Review Press; 2013.Google Scholar
- 22.Heart rate notifications on your Apple Watch [Internet]. Apple Support. [cited 2019 May 2]. Available from: https://support.apple.com/en-us/HT208931.
- 23.Overview of device regulation [Internet]. US Food and Drug Administration. [cited 2019 Jun 28]. Available from: https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation.
- 28.Turakhia MP, Perez MV. Results of a large-scale, App-based study to identify atrial fibrillation using a smartwatch: the Apple Heart Study. Oral session presented at: American College of Cardiology Scientific Sessions 2019. 2019 Mar 16–18. New Orleans, LA.Google Scholar
- 31.• Koshy AN, Sajeev JK, Negishi K, Wong MC, Pham CB, Cooray SP, et al. Accuracy of blinded clinician interpretation of single-lead smartphone electrocardiograms and a proposed clinical workflow. Am Heart J. 2018;205:149–53 This study compared the test characteristics of the AliveCor rhythm classification algorithm to interpretation of single-lead AliveCor tracings by primary care providers and electrophysiologists in a sample of 100 individuals undergoing cardioversion with gold-standard 12-lead ECGs. The study demonstrated that supplementing device algorithms with physician interpretation improves AF detection over either alone. CrossRefGoogle Scholar
- 35.Using Apple Watch for arrhythmia detection December 2018 [Internet]. 2018 [cited 2019 May 16]. Available from: https://www.apple.com/healthcare/site/docs/Apple_Watch_Arrhythmia_Detection.pdf.
- 37.• Wasserlauf J, You C, Patel R, Valys A, Albert D, Passman R. Smartwatch performance for the detection and quantification of atrial fibrillation. Circulation: Arrhythmia and Electrophysiology [Internet]. 2019 [cited 2019 May 29];12. Available from: https://www.ahajournals.org/doi/10.1161/CIRCEP.118.006834 This study compared the KardiaBand device to conventional implantable cardiac monitors in 24 patients with paroxysmal AF, finding that the KardiaBand is highly sensitive for detecting episodes of AF lasting more than 1 h. The results suggest that wearable devices may be useful for long-term noninvasive monitoring for AF.
- 39.Alonso A, Roetker NS, Soliman EZ, Chen LY, Greenland P, Heckbert SR. Prediction of atrial fibrillation in a racially diverse cohort: the Multi-Ethnic Study of Atherosclerosis (MESA). J Am Heart Assoc. 2016;5.Google Scholar
- 40.FDA permits marketing of artificial intelligence-based device to detect certain diabetes-related eye problems [Internet]. FDA Newsroom. 2018. Available from: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm604357.htm.
- 41.Kapoor A, Amroze A, Golden J, Crawford S, O’Day K, Elhag R, et al. SUPPORT-AF: piloting a multi-faceted, electronic medical record-based intervention to improve prescription of anticoagulation. J Am Heart Assoc [Internet]. 2018 [cited 2019 Jun 28];7. Available from: https://www.ahajournals.org/doi/10.1161/JAHA.118.009946.
- 44.Institutions that support health records on iPhone (beta) [Internet]. Apple Support. 2019 [cited 2019 May 16]. Available from: https://support.apple.com/en-us/HT208647.
- 45.VA to provide capability for veterans to access their VA health data on Apple iPhones [Internet]. U.S. Department of Veteran Affairs News Releases. 2019 [cited 2019 May 16]. Available from: https://www.va.gov/opa/pressrel/pressrelease.cfm?id=5199.
- 46.Fitbit and Google announce collaboration to accelerate innovation in digital health and wearables [Internet]. Fitbit Press Releases. 2018 [cited 2019 Jun 28]. Available from: https://investor.fitbit.com/press/press-releases/press-release-details/2018/Fitbit-and-Google-Announce-Collaboration-to-Accelerate-Innovation-in-Digital-Health-and-Wearables/default.aspx.
- 47.AMA, Google launch health care interoperability & innovation challenge [Internet]. AMA Press Releases. 2018 [cited 2019 Jun 28]. Available from: https://www.ama-assn.org/press-center/press-releases/ama-google-launch-health-care-interoperability-innovation-challenge.
- 48.KardiaPro [Internet]. AliveCor. [cited 2019 May 2]. Available from: https://clinicians.alivecor.com.
- 49.QardioMD [Internet]. GetQardio. [cited 2019 May 2]. Available from: https://www.getqardio.com/qardiomd-heart-health/.
- 54.The HEARTLINE Study [Internet]. The HEARTLINE Study. 2019 [cited 2019 May 16]. Available from: https://www.heartline.com.
- 55.•• Halcox JPJ, Wareham K, Cardew A, Gilmore M, Barry JP, Phillips C, et al. Assessment of remote heart rhythm sampling using the AliveCor heart monitor to screen for atrial fibrillation: The REHEARSE-AF Study. Circulation. 2017;136:1784–94 This randomized controlled trial compared screening with intermittent twice weekly handheld AliveCor Kardia ECGs for 12 months to usual care, and found that intermittent screening was more likely to detect incident AF in patients ≥ 65 years of age. It also estimated cost-effectiveness of such ambulatory screening, suggesting a cost per diagnosis of $10,780. CrossRefGoogle Scholar
- 56.Hickey KT, Hauser NR, Valente LE, Riga TC, Frulla AP, Creber RM, Whang W, Garan H, Jia H, Sciacca RR, Wang DY A single-center randomized, controlled trial investigating the efficacy of a mHealth ECG technology intervention to improve the detection of atrial fibrillation: the iHEART study protocol. BMC Cardiovasc Disord [Internet]. 2016 [cited 2019 Mar 5];16. Available from: http://bmccardiovascdisord.biomedcentral.com/articles/10.1186/s12872-016-0327-y
- 58.Galloway CD, Valys AV, Shreibati JB, Treiman DL, Petterson FL, Gundotra VP, et al. Development and validation of a deep-learning model to screen for hyperkalemia from the electrocardiogram. JAMA Cardiology [Internet]. 2019 [cited 2019 May 6]; Available from: http://cardiology.jamanetwork.com/article.aspx?doi=10.1001/jamacardio.2019.0640.
- 59.Medicare Program; Revisions to payment policies under the physician fee schedule and other revisions to part B for CY 2019; Medicare Shared Savings program Requirements; Quality Payment Program; Medicaid Promoting Interoperability Program; Quality Payment Program--extreme and uncontrollable circumstance policy for the 2019 MIPS payment year; provisions from the Medicare Shared Savings Program--accountable care organizations--pathways to success; and expanding the use of telehealth services for the treatment of opioid use disorder under the substance use-disorder prevention that promotes opioid recovery and treatment (SUPPORT) for patients and communities act [internet]. Centers for Medicare & Medicaid Services; 2018 Nov. Available from: https://s3.amazonaws.com/public-inspection.federalregister.gov/2018-24170.pdf.
- 61.Sullivan HR, Schweikart SJ. Are current tort liability doctrines adequate for addressing injury caused by AI? AMA J Ethics. 2019;21:E160–6.Google Scholar