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 indicate there are 440 million wearables in patients hands worldwide.
• Wearables collect data on individual health metrics, typically for rhythm disorders and include:

o Heart rate

o?? Heart rhythm

o?? ECG

o?? Oxygen saturation

o?? Accelerometer

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

o?? Early detection of cardiac events

o?? Chronic disease management – especially with frequent hospitalizations

o?? 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.

o?? 81 devices had recently published articles on clinical validation

o?? 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 for suspicion 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:

o?? Stroke

o?? Heart Failure

o?? Hospitalization

o?? Mortality

o?? 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:

o?? Incidence of high atrial rate events

o?? 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 orsystem 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 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

o?? Large amounts of patient data vulnerable to data breaches

o?? Ensuring privacy is paramount

• Accuracy and Reliability

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

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

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

• Improved Patient Engagement

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

o?? High rates of device discontinuation due to poor user experience.

• Signal frequency and resolution?

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

o?? 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, Pharm.D., FCCM is a clinician and transformational healthcare executive with 20+ years experience developing innovative solutions to improve clinical outcomes, enhance provider experience and increase revenue.

Dr. Hassan aids health systems and providers by making telemedicine a reality as well as improving the process of difficult clinical challenges using evidence based clinical data creating and optimizing intelligent ecosystems to generate validated patient centered clinical and financial outcomes.

You can reach Erkan at [email protected]