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

Abstract

Aim: 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). Research design and methods: 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. Results: 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). Conclusion: 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.