Validity of Wearable ECGs

Selected studies on the validity and clinical efficacy of wearable ECGs

Cardiovascular Digital Health Journal | 2022

5 MDs from Amsterdam University Medical Center
The single-lead ECG of the Apple Watch shows a high accuracy for identifying AF in a clinical setting.
Pepplinkhuizen, Shari, et al. "Accuracy and clinical relevance of the single-lead Apple Watch electrocardiogram to identify atrial fibrillation." Cardiovascular Digital Health Journal 3.6 (2022): 17-22

The Lancet ‘EClinicalMedicine’ | 2019

Multi-Centre Randomised Controlled Trial
243 participants followed over 18 months
Assessment of the use of Apple Watch smartphone-based event recorders resulted in greater detection rate and faster rhythm detection time.
Use of a smartphone-based event recorder increased the number of patients in whom an ECG was captured during symptoms over five-fold.
The study trial illustrated the potential application and effectiveness of wearable ECG devices.
“This safe, non-invasive and easy to use device should be considered part of on-going care to all patients presenting acutely with unexplained palpitations or pre-syncope.”
Reed, Matthew J., et al. "Multi-centre randomised controlled trial of a smartphone-based event recorder alongside standard care versus standard care for patients presenting to the emergency department with palpitations and pre-syncope." EClinicalMedicine (Lancet Discovery). 8 (2019): 37-46.
ID: NCT02783898
Link: clinicaltrials.gov

National Institute for Health Research | 2020

NIHR Health Technology Assessment
Based on systematic review of MEDLINE, MEDLINE Epub Ahead of Print and MEDLINE In-Process & Other Non-Indexed Citations, EMBASE, PubMed, Cochrane Databases of Systematic Reviews, Cochrane Central Database of Controlled Trials, Database of Abstracts of Reviews of Effects and the Health Technology Assessment Database.
Single time point lead-I ECG devices for the detection of AF in people with signs or symptoms of AF and an irregular pulse appear to be a cost-effective use of NHS resources compared with MPP followed by a 12-lead ECG in primary or secondary care, given the assumptions used in the base-case model.
Duarte R, Stainthorpe A, Greenhalgh J, Richardson M, Nevitt S, Mahon J, Kotas E, Boland A, Thom H, Marshall T, Hall M, Takwoingi Y. Lead-I ECG for detecting atrial fibrillation in patients with an irregular pulse using single time point testing: a systematic review and economic evaluation. Health Technol Assess. 2020 Jan;24(3):1-164.

New England Journal of Medicine | 2019

419,297 participants over 8 months
Apple Watch correctly detected AF in 84% of participants
This large study confirms Apple Watch's ability to detect AF in over 400,000 participants.
Perez, Marco V., et al. "Large-scale assessment of a smartwatch to identify atrial fibrillation." New England Journal of Medicine 381.20 (2019): 1909-1917.
ID: NCT03335800 “Apple Heart Study“
Link: clinicaltrials.gov

EP Europace | 2023

All patients underwent simultaneous 12-lead ECG recordings with a 30-second sl-ECG from an Apple Watch Series 6 and a CART-I Ring
Two cardiologists independently adjudicated all ECGs; any disagreements were resolved by a third cardiologist
A total of 1600 ECGs from 400 consecutive patients were recorded
In patients with cardiovascular disease, automatic AF detection algorithms from wearable devices have a higher rate of false-positive detections than previously reported. Physician-interpreted sl-ECGs have excellent diagnostic accuracy for AF.
Briosa E Gala, A., Sharp, A. J., Schramm, D., Ries, W., Pope, M. T. B., Leo, M., … & Betts, T. R. (2023). Single-lead ECGs with wearable technology: diagnostic accuracy in patients with cardiovascular disease. Europace, 25, 122-619