Validation of a smartphone-based event recorder for arrhythmia detection

Area of Science:

• Cardiology
• Medical Devices
• Digital Health

Background:

• Ambulatory cardiac monitoring is crucial for diagnosing palpitations.
• External loop recorders (ELRs) are commonly used but can be cumbersome.
• Smartphone-based ECG recorders offer a potential alternative.

Purpose of the Study:

• To compare the diagnostic yield of smartphone-based ECG recorders (Kardia Mobile [KM]) versus traditional external loop recorders (ELRs).
• To evaluate patient preference and compliance between KM and ELR devices.

Main Methods:

• A study involving 33 patients with palpitations who simultaneously used KM and ELR for 14-30 days.
• Patients activated devices during symptomatic episodes; tracings were independently analyzed by cardiologists.
• Noninferiority was assessed using an unconditional test for paired binomial data.

Main Results:

• Kardia Mobile (KM) identified potential diagnoses in 89.5% of patients versus 68.4% for ELRs (P=0.024).
• In per-protocol analysis, KM achieved a 100% diagnosis rate compared to 72.2% for ELRs (P=0.001).
• Higher patient preference and compliance were observed with KM due to its ease of use and portability.

Conclusions:

• Smartphone-based ECG recorders (KM) are noninferior to ELRs for arrhythmia detection in outpatient settings.
• KM's convenience and portability make it a valuable tool for diagnosing symptomatic arrhythmias.
• This technology enhances patient experience and diagnostic accuracy in ambulatory cardiac monitoring.