A Pilot Study of the Home-Based 12-Lead Electrocardiogram in Clinical Practice

Area of Science:

• Cardiology
• Medical Devices
• Digital Health

Background:

• Telehealth consultations offer convenience for patients.
• Remote monitoring devices can enhance telehealth efficacy.
• Evaluating new technologies for remote cardiac assessment is crucial.

Purpose of the Study:

• To assess the feasibility and efficiency of the FDA-approved Smeartheart 12-lead ECG device for remote patient use.
• To evaluate the quality of ECGs obtained remotely before telehealth appointments.
• To identify barriers to the use of the Smeartheart device in a home setting.

Main Methods:

• Pilot study involving 10 patients using the Smeartheart device at home.
• Remote ECG acquisition prior to telehealth consultations with a cardiac electrophysiologist.
• Data collection on ECG quality, time, and patient attempts.

Main Results:

• Eight out of ten patients obtained diagnostic quality ECGs.
• ECG technician phone calls averaged 51 minutes.
• Patients required an average of 2.2 attempts to record a usable ECG.

Conclusions:

• The Smeartheart device demonstrates potential clinical utility for remote 12-lead ECG monitoring in routine care.
• Barriers such as internet connectivity, training, and motion artifact require further investigation.
• Additional research is needed to optimize the use of this remote ECG technology.