Dr. Erkan Hassan

Monthly Writings

Evaluations and reviews of the latest in the field.

Digital Health Wearables: A Focus on Atrial Fibrillation

SUMMARY:

  • Healthcare wearables have exploded onto the care delivery scene

  • Although they can provide early identification, do they really offer opportunities for improving outcomes?

  • As wearables evolve, artificial intelligence and resolution of privacy issues should significantly improve the management of the conditions they monitor.

REVIEW

  • Digital health wearables are electronic devices designed to be worn on the body in various ways.

  • Typically equipped with sensors, they measure vital signs and biometric data which can then be transmitted to a healthcare provider or be used for self monitoring.

  • Current estimates are there are 440 million wearables in patients hands worldwide.

  • Wearables collect data on individual health metrics, typically for rhythm disorders and include:

    • Heart rate

    • Heart rhythm

    • ECG

    • Oxygen saturation

    • Accelerometer

  • The potential benefits of wearables are based on proactive health management and timely medical interventions of:

    • Early detection of cardiac events

    • Chronic disease management – especially with frequent hospitalizations

    • Patient Empowerment of real time data

FOCUS ON ATRIAL FIBRILLATION:

  • There are greater than 300 million ECG’s obtained annually worldwide

  • Atrial fibrillation occurs in approximately 4% of adults older than 60 years of age.

  • Mobile ECG digital devices can focus on identifying rhythm disorders.

  • Zepeda-Echavarria et al JMIR Cardio 2023;7:e44003 (doi: 10.2196.44003) recently reviewed the published data on ECG devices for home use.

    • 81 devices had recently published articles on clinical validation

    • 58 of 81 devices also [provided information on the device on the manufacturers website

      • 21 devices did not state it had an intended use for rhythm disorders

      • 31 devices stated an intended use of:

        • Arrhythmia 25 devices

          Atrial Fibrillation 6 devices

  • Most devices can detect atrial fibrillation with a sensitivity between 54.5% to 94%

  • Continuously monitored devices showed better performance than intermittent monitoring devices.

Is Home Monitoring of Atrial Fibrillation with Digital Devices Important:

  • Clinically Symptomatic Atrial Fibrillation is associated with increased risks of:

    • Stroke

    • Heart Failure

    • Hospitalization

    • Mortality

    • Cognitive decline

  • If the atrial fibrillation detected by wearable home devices are subclinical, it is unknown if patients will have the same consequences.

  • Two areas should be noted:

    • Incidence of high atrial rate events

    • Duration of atrial fibrillation (Waldo & Camm Circulation 2017:136;1795)

      • Subclinical Atrial Fibrillation lasting greater than 24 hours is associated with an increased risk of ischemic stroke or systemic embolism

      • High Atrial Rate Events:

        • Greater than 6 minutes duration: associated with  a 2.5 fold risk of ischemic stroke or system embolism

        • Greater than 3.8 hour/day: 9 times increased risk of ischemic stroke or systemic embolism

        • Greater 5.5 hours/day in 30 days: double the thromboembolic risk

  • Based on these 2 considerations, it remains unclear when and how to justify the initiation of treatment based on these findings.

CHALLENGES WITH DIGITAL HEALTH WEARABLES:

  • Data Privacy and Security

    • Large amounts of patient data vulnerable to data breaches

    • Ensuring privacy is paramount

  • Accuracy and Reliability

    • Noise and artifact resulting in 2-15% of ECGs being uninterpretable

    • Currently there is a disconnect between the vast amount of data generated and provision of actionable healthcare decisions.

    • Clinical validation studies are needed to ensure accuracy across various target patient populations.

  • Improved Patient Engagement

    • Adoption remains limited with only 38% of patients with cardiovascular disease using a smartwatch daily.

    • High rates of device discontinuation due to poor user experience.

  • Signal frequency and resolution

    • Determine the right “Monitoring Dose” to capture meaningful changes in data.

    • Different titration at home vs standard monitoring in hospital.

CONCLUSIONS:

  • Digital health wearables are positioned to transform how patients are monitored and treated.

  • They may improve early detection and chronic disease management.

  • Challenges remain and must be addressed before they can reach their full potential

Erkan Hassan