Apple Heart Study publication offers further insights on AF detection from wearables
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Results of the Apple Heart Study that were presented earlier this year at the American College of Cardiology Scientific Session have been published in The New England Journal of Medicine.
Presented data at ACC
As Cardiology Today previously reported at the meeting, the large-scale, app-based study enrolled 419,297 participants during an 8-month period, of whom 0.52% received an irregular pulse notification. Nearly half of participants (44%; n = 945) who received a notification went on to attend the first telehealth study visit. The ECG patch was mailed to 70% of participants (n = 658) and 68% returned their patch for analysis. Mean time to hookup was 13 days and mean wear time was 6.3 days. Of 450 participants who received an ECG patch to wear at home, 34.8% had observed atrial fibrillation (97.5% CI, 27-43).
“The absence of atrial fibrillation on a subsequent ECG patch does not imply that the initial notification was a false positive,” Marco Perez, MD, associate professor of medicine (cardiovascular medicine) at Stanford University Medical Center, and colleagues wrote. “Rather, atrial fibrillation may have been paroxysmal and infrequent, which is the most common pattern in early-stage atrial fibrillation. The index atrial fibrillation episode may have ended by the time the ECG patch was worn.”
All participants who received a notification of irregular heartbeat were asked to respond to a survey at 90 days to collect insights into the care pathway used in the Apple Heart Study; 64% responded. Of those, 15% admitted that they had AF before they self-enrolled in the Apple Heart study. There were 57% of patients who reported contacting a nonstudy provider. Of those, 28% started a new medication, 33% were referred to a specialist and 36% underwent additional testing.
“Rigorous investigation of this technology and of its use in a clinical setting is needed, including the ways this technology can guide further evaluation and treatment to improve clinical outcomes,” Perez and colleagues wrote. “Finally, this study provides a foundation on which further research in digital health can be conducted.”
Future research, potential concerns
The publication also included an editorial written by Edward W. Campion, MD, executive editor and online editor of NEJM, and John A. Jarcho, MD, assistant professor at Harvard Medical School and deputy editor of NEJM, in which they wrote: “The main message from the Apple Heart Study lies not in the technology tested, which is rapidly evolving and changing. The lessons lie in how the study was done and why it was done. People have been wearing fitness monitors for many years, but now we’re seeing the appeal of a watch with an app that can detect arrhythmias that may justify medical evaluation and treatment.”
Although Campion and Jarcho agree that wearable devices and the Apple Heart Study itself will facilitate research, there may be some hesitation from patients on the accessibility of their health care data, according to the editorial.
“Again and again we have seen privacy violations, sometimes because of negligent security and sometimes because of deliberate and deceptive misuse of personal data,” they wrote. “The uncomfortable fact is that our personal health data have considerable financial value to those who want to use them in the myriad marketplaces connected to our $3.7 trillion health economy. As we implement novel technology for improving human health, physicians need to help protect the interests of patients against the use of technology that ignores the greater good.” – by Darlene Dobkowski
Disclosures: The study was sponsored by Apple. Perez reports he received grants and personal fees from Apple along with personal fees from Boehringer Ingelheim. Campion reports he is the executive editor of The New England Journal of Medicine. Jarcho reports he is the deputy editor of The New England Journal of Medicine. Please see the study for all other authors’ relevant financial disclosures.
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