Smart Watch Helps Detect Irregular Heart Rhythm

Verily Study Watch - a first-ever FDA-approved clinically prescribed wrist-worn device, precisely detects atrial fibrillation, (Afib) an irregular heartbeat, that is known to raise the risk of heart attack and stroke. Using a technique called photoplethysmography, the watch accurately monitors heart rhythm while avoiding false positive results. The results are published in the Journal of the American Heart Association (1^✔ ✔Trusted Source
Clinical smart watch finds success at identifying atrial fibrillation

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Clinical Smart-Watch Proven Reliable to Monitor Atrial Fibrillation

As the use of wearable technology grows, smart-watches are marketed across the globe to consumers as a way to monitor health.

“Unfortunately, this has led to a tsunami of healthy patients coming to clinics complaining about having atrial fibrillation, and we see many false positives without really having a way to use these devices clinically,” said Hamid Ghanbari, M.D., M.P.H., a cardiac electrophysiologist the University of Michigan Health Frankel Cardiovascular Center.

To address the clinical gap, a research team led by Ghanbari developed a prescription wristwatch that continuously monitors the wearer’s heart rhythm and uses a unique algorithm to detect atrial fibrillation.

Much like consumer wearable devices, the Verily Study Watch detects subtle changes in heart rhythm by sending light pulses through the skin into the blood vessels, a process known as photoplethysmography.

If it suspected atrial fibrillation, the device would prompt a user to take a single-lead ECG to determine if the algorithm correctly identified Afib. The results would then be reviewed by a cardiographic technician before it was reported to the participant’s physician.

The device analyzed data every 15 minutes, and its deep neural network algorithm determined whether over 100 participants had atrial fibrillation between September 2020 and May 2021.

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The study watch correctly identified atrial fibrillation in the vast majority of participants, with levels of false negatives and positives that were similar to other devices for the detection of Afib using similar photoplethysmography technology.

Although there was a decrease in performance of the device for some episodes of atrial fibrillation for participants with darker skin tones, it was still able to detect Afib in those patients. Researchers say this is the first study to report the performance of the photoplethysmography-based algorithm for participants at all levels of physical activity.

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The device’s accuracy in detecting atrial fibrillation was comparable during low and moderate levels of activity. Consumer-facing devices, like Apple Watch and Fitbit, are cleared by the United States Food and Drug Administration for pre-diagnostic purposes but are not intended for clinical decision-making.

This device, Ghanbari says, could provide the link that allows providers to effectively use data from wearables to manage patients with Afib. “The prescription Study Watch bridges the gap between long-term, continuous monitoring that is currently more invasive and the consumer space with a practical solution for Afib detection and burden assessment,” he said.

“It is not intended to replace interval ECG monitoring for patients who need it. However, the multistage system may also limit the burden on clinicians and avoid the deluge of notifications generated by other wrist-worn devices that rarely result in clinically actionable findings.”

The creator of the watch, Verily Life Sciences, received 510(k) clearance from the FDA, a premarket submission to demonstrate the product’s efficacy and similarity to a legally marketed device.

“There is a need for clinical grade wrist-worn wearable that is affordable and can be prescribed by clinicians for the long term, personalized and continuous management of patients with Afib,” Ghanbari said.

Reference:

1. Clinical smart watch finds success at identifying atrial fibrillation - (https://www.michiganmedicine.org/health-lab/clinical-smart-watch-finds-success-identifying-atrial-fibrillation)

Source-Eurekalert