Clinical evaluation and diagnostic yield following evaluation of abnormal pulse detected using Apple Watch

Abstract

Objective The study sought to characterize the evaluation of patients who present following detection of an abnormal pulse using Apple Watch. Materials and Methods We conducted a retrospective review of patients evaluated for abnormal pulse detected using Apple Watch over a 4-month period. Results Among 264 included patients, clinical documentation for 41 (15.5%) explicitly noted an abnormal pulse alert. Preexisting atrial fibrillation was noted in 58 (22.0%). Most commonly performed testing included 12-lead echocardiography (n = 158; 59.8%), Holter monitor (n = 77; 29.2%), and chest x-ray (n = 64; 24.2%). A clinically actionable cardiovascular diagnosis of interest was established in only 30 (11.4%) patients, including 6 of 41 (15%) patients who received an explicit alert. Discussion False positive screening results may lead to overutilization of healthcare resources. Conclusions The Food and Drug Administration and Apple should consider the unintended consequences of widespread screening for asymptomatic (“silent”) atrial fibrillation and use of the Apple Watch abnormal pulse detection functionality by populations in whom the device has not been adequately studied.

Validation of an algorithm for continuous monitoring of atrial fibrillation using a consumer smartwatch

“…For example, although the Apple Watch has approval from the US Food and Drug Administration for their W-PPG and W-ECG technology, the device has not been adequately studied, and postmarket surveillance demonstrated a high false-positive rate, with only 15% of patients who received an abnormal pulse alert on an Apple Watch having AF confirmed. 22 Importantly, by incorporating data from the raw PPG signals and the other sensors in the watch, we were able to Values are given as % unless otherwise indicated. AF 5 atrial fibrillation; AUC area under the receiver operator characteristic curve; CI 5 confidence interval; P-ECG 5 patch electrocardiography; SENS 5 sensitivity; SENS est 5 estimated sensitivity using logistic regression; SPEC 5 specificity; SPEC est 5 estimated sensitivity using logistic regression; SR 5 sinus rhythm; TN 5 number of true-negative events (SR on P-ECG); TP 5 number of true-positive events (AF on P-ECG); W-ECG watch electrocardiography; W-PPG 5 watch photoplethysmography.…”

Association of Wearable Device Use With Pulse Rate and Health Care Use in Adults With Atrial Fibrillation

“…Like our results, those of prior studies raised questions about effective ways to apply wearable technology to improve health outcomes. A 2020 retrospective analysis 24 of Apple Watch alerts found that 11% of alerts were associated with a clinically actionable event. Another study of inpatients on telemetry 7 found poor sensitivity of smartwatch AF detection among patients after cardiac surgical treatment, a group known to have a high arrhythmia burden.…”

Smart Wearables for Cardiac Monitoring—Real-World Use beyond Atrial Fibrillation

“…AI is often considered a “black-box” technology, making it difficult for some clinicians to trust the results or communicate the meaning of AI-derived findings to patients [ 135 , 136 ]. Moreover, a recent study of abnormal pulse detected by the Apple Watch found that nearly 90% of the alerts did not lead to clinically actionable diagnoses, leading to concerns of increased low-value health utilization [ 137 ].…”