Apple Watch Rear Sensors"Only one in seven self-referrals to physicians confirm a cardiac irregularity alert with an Apple Watch. The Apple Watch is not a diagnostic monitor and serves only as a screening device.
"The observation that new clinically actionable cardiovascular diagnoses of interest were diagnosed in only 11.4% of patients following medical evaluation as directed by the treating provider suggests a high false-positive rate as a screening tool for undiagnosed cardiovascular disease," Mayo Clinic researchers wrote in the Journal of the American Medical Informatics Association. "False-positive screening results have the potential to lead to excessive healthcare resource utilization and anxiety among the 'worried well.'”
The retrospective look at clinical documentation also suggests that a sizable portion of those presenting used the Apple Watch's feature "in a manner inconsistent with FDA guidance." The abnormal pulse detection feature is accessible across all generations of Apple Watch devices and is not to be confused with the ECG atrial fibrillation tool introduced with the Series 4 Apple Watch.
Among 264 patients whose clinical documentation was included in the study, 15.5% had records explicitly noting an abnormal pulse alert generated by the feature. The remainder included a reference to the watch and detection of abnormal pulse but did not explicitly mention that the user had received a generated alert, which the researchers noted could be a result of either incomplete documentation or the patient's manual use of the Apple Watch's heart monitoring application.
Patients who experienced symptoms were more likely to undergo diagnostic testing as part of their evaluation (78.5% versus 60.9%; p = .004). There was no significant difference in the proportion of patients with or without a documented abnormal pulse alert from the watch who underwent diagnostic testing.
Overall, 11.4% of patients received clinically actionable diagnoses. This diagnosis rate rose slightly to 15% among those documented to have received the alert.
"Therefore, for patients who experienced an abnormal pulse alert and presented for medical evaluation, 7 (95% confidence interval, 3.5-14.5) patients needed to be evaluated to establish [one] diagnosis of clinically actionable cardiovascular disease," the researchers wrote. "Among the 15 asymptomatic patients who presented following an abnormal pulse alert, only one was diagnosed with a clinically actionable cardiovascular diagnosis, yielding a number needed to diagnose of 15 (95% confidence interval, 2.9-286.5)."
Also of note were the patient populations included in the analysis. Twenty-two percent had pre-existing atrial fibrillation and 8.7% were younger than 22 years – both of which would exclude these patients from the FDA's guidance for this feature."
Author's note:
Regardless of the Mayo Clinic's FDA's guidance for use of the Apple watch physicians must make the evaluation and determination for each patient. The data reveals that the information must be taken with historical information. Physical examination is also part of the mandatory evacuation. The comments about the increase in utilization may affect health plan coverage.
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