Validation of diagnostic accuracy of a handheld, smartphone-based rhythm recording device

Evaluation of the diagnostic accuracy of a rhythm recording device, for detection of atrial tachyarrhythmia (ATA) and atrial fibrillation (AF) compared to 12-lead-electrocardiogram (12-L-ECG).

Two hundred 12-L-ECGs (reference standard) and Coala Heart Monitor (CHM) recordings (index test) were collected from 189 patients. Two electrophysiologists independently performed manual analysis of all 12-L-ECGs and CHM recordings in random order. The CHM recordings were also analyzed by an automatic algorithm and compared to the results of the reference standard.

Manual analysis of CHM for ATA showed a sensitivity of 98.9% (95% confidence interval (CI): 94.0-100) and a specificity of 100% (CI: 96.6-100). Manual analysis for AF had a sensitivity of 100% (CI: 95.3-100) and a specificity of 97.5% (CI: 93.0-99.5). Automatic analysis for ATA showed a sensitivity of 93.5% (CI: 86.3-97.6) and a specificity of 92.6% (CI: 85.9-96.7). Automatic analysis for AF showed a sensitivity of 97.4% (CI: 91.0-99.7) and a specificity of 86.1% (CI: 78.6-91.7).

CHM has a very high accuracy for ATA and AF in manual analysis and a high accuracy for ATA and AF in automatic analysis, making the device suitable for screening.