Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation
Marco V Perez, Kenneth W Mahaffey, Haley Hedlin, John S Rumsfeld, Ariadna Garcia, Todd Ferris, Vidhya Balasubramanian, Andrea M Russo, Amol Rajmane, Lauren Cheung, Grace Hung, Justin Lee, Peter Kowey, Nisha Talati, Divya Nag, Santosh E Gummidipundi, Alexis Beatty, Mellanie True Hills, Sumbul Desai, Christopher B Granger, Manisha Desai, Mintu P Turakhia, Apple Heart Study Investigators, Marco V Perez, Mintu P Turakhia, Karma Lhamo, Shea Smith, Maya Berdichesky, Bhanu Sharma, Kenneth Mahaffey, Justin Parizo, Christoph Olivier, Mai Nguyen, Sushmitha Tallapalli, Rajvir Kaur, Rebecca Gardner, Grace Hung, Don Mitchell, Garrick Olson, Somalee Datta, Dmitry Gerenrot, Xu Wang, Patrick McCoy, Bikas Satpathy, Hans Jacobsen, Dmitry Makovey, Andrew Martin, Alex Perino, Connor O'Brien, Avani Gupta, Christine Toruno, Steve Waydo, Chris Brouse, Danielle Dorfman, Jeff Stein, Jerry Huang, Mithun Patel, Steve Fleischer, Evan Doll, Mike O'Reilly, Kelsey Dedoshka, Ming Chou, Heather Daniel, Matt Crowley, Candace Martin, Tim Kirby, Maz Brumand, Kelly McCrystale, Myra Haggerty, Jennifer Newberger, Dan Keen, Peter Antall, Kristina Holbrook, Allison Braly, Garrett Noone, Ben Leathers, Alisa Montrose, Jeff Kosowsky, Danielle Lewis, J R Finkelmeier, Kristen Bemis, Kenneth W Mahaffey, Manisha Desai, Nisha Talati, Divya Nag, Amol Rajmane, Sumbul Desai, Deidre Caldbeck, Lauren Cheung, Christopher Granger, John Rumsfeld, Peter R Kowey, Mellanie T Hills, Andrea Russo, Frank Rockhold, Christine Albert, Alvaro Alonso, Lisa Wruck, Karen Friday, Matthew Wheeler, Chad Brodt, Shirley Park, Albert Rogers, Ronald Jones, David Ouyang, Lee Chang, Alberta Yen, Julie Dong, Petra Mamic, Paul Cheng, Rajan Shah, Peem Lorvidhaya, Marco V Perez, Kenneth W Mahaffey, Haley Hedlin, John S Rumsfeld, Ariadna Garcia, Todd Ferris, Vidhya Balasubramanian, Andrea M Russo, Amol Rajmane, Lauren Cheung, Grace Hung, Justin Lee, Peter Kowey, Nisha Talati, Divya Nag, Santosh E Gummidipundi, Alexis Beatty, Mellanie True Hills, Sumbul Desai, Christopher B Granger, Manisha Desai, Mintu P Turakhia, Apple Heart Study Investigators, Marco V Perez, Mintu P Turakhia, Karma Lhamo, Shea Smith, Maya Berdichesky, Bhanu Sharma, Kenneth Mahaffey, Justin Parizo, Christoph Olivier, Mai Nguyen, Sushmitha Tallapalli, Rajvir Kaur, Rebecca Gardner, Grace Hung, Don Mitchell, Garrick Olson, Somalee Datta, Dmitry Gerenrot, Xu Wang, Patrick McCoy, Bikas Satpathy, Hans Jacobsen, Dmitry Makovey, Andrew Martin, Alex Perino, Connor O'Brien, Avani Gupta, Christine Toruno, Steve Waydo, Chris Brouse, Danielle Dorfman, Jeff Stein, Jerry Huang, Mithun Patel, Steve Fleischer, Evan Doll, Mike O'Reilly, Kelsey Dedoshka, Ming Chou, Heather Daniel, Matt Crowley, Candace Martin, Tim Kirby, Maz Brumand, Kelly McCrystale, Myra Haggerty, Jennifer Newberger, Dan Keen, Peter Antall, Kristina Holbrook, Allison Braly, Garrett Noone, Ben Leathers, Alisa Montrose, Jeff Kosowsky, Danielle Lewis, J R Finkelmeier, Kristen Bemis, Kenneth W Mahaffey, Manisha Desai, Nisha Talati, Divya Nag, Amol Rajmane, Sumbul Desai, Deidre Caldbeck, Lauren Cheung, Christopher Granger, John Rumsfeld, Peter R Kowey, Mellanie T Hills, Andrea Russo, Frank Rockhold, Christine Albert, Alvaro Alonso, Lisa Wruck, Karen Friday, Matthew Wheeler, Chad Brodt, Shirley Park, Albert Rogers, Ronald Jones, David Ouyang, Lee Chang, Alberta Yen, Julie Dong, Petra Mamic, Paul Cheng, Rajan Shah, Peem Lorvidhaya
Abstract
Background: Optical sensors on wearable devices can detect irregular pulses. The ability of a smartwatch application (app) to identify atrial fibrillation during typical use is unknown.
Methods: Participants without atrial fibrillation (as reported by the participants themselves) used a smartphone (Apple iPhone) app to consent to monitoring. If a smartwatch-based irregular pulse notification algorithm identified possible atrial fibrillation, a telemedicine visit was initiated and an electrocardiography (ECG) patch was mailed to the participant, to be worn for up to 7 days. Surveys were administered 90 days after notification of the irregular pulse and at the end of the study. The main objectives were to estimate the proportion of notified participants with atrial fibrillation shown on an ECG patch and the positive predictive value of irregular pulse intervals with a targeted confidence interval width of 0.10.
Results: We recruited 419,297 participants over 8 months. Over a median of 117 days of monitoring, 2161 participants (0.52%) received notifications of irregular pulse. Among the 450 participants who returned ECG patches containing data that could be analyzed - which had been applied, on average, 13 days after notification - atrial fibrillation was present in 34% (97.5% confidence interval [CI], 29 to 39) overall and in 35% (97.5% CI, 27 to 43) of participants 65 years of age or older. Among participants who were notified of an irregular pulse, the positive predictive value was 0.84 (95% CI, 0.76 to 0.92) for observing atrial fibrillation on the ECG simultaneously with a subsequent irregular pulse notification and 0.71 (97.5% CI, 0.69 to 0.74) for observing atrial fibrillation on the ECG simultaneously with a subsequent irregular tachogram. Of 1376 notified participants who returned a 90-day survey, 57% contacted health care providers outside the study. There were no reports of serious app-related adverse events.
Conclusions: The probability of receiving an irregular pulse notification was low. Among participants who received notification of an irregular pulse, 34% had atrial fibrillation on subsequent ECG patch readings and 84% of notifications were concordant with atrial fibrillation. This siteless (no on-site visits were required for the participants), pragmatic study design provides a foundation for large-scale pragmatic studies in which outcomes or adherence can be reliably assessed with user-owned devices. (Funded by Apple; Apple Heart Study ClinicalTrials.gov number, NCT03335800.).
Copyright © 2019 Massachusetts Medical Society.
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Source: PubMed