P580Performance evaluation of dual vs. single lead automatic, real-world arrhythmic ECG recordings

Abstract

Abstract Background Detection of treatment-demanding paroxysmal arrhythmias can be difficult. Use of single lead ECG recordings for detection of Atrial Fibrillation (AF) has shown to lead to high false positive discovery rates, and requirements of additional manual clinical interpretation or 12-lead ECG to reach satisfactory diagnostic precision. Use of sequential, dual-lead ECG recordings for detection of AF has indicated significant clinical improvement in detection yield of AF and reduction of false positive discovery rates as compared to single lead-ECG. Methods The Coala Heart Monitor (Coala Life AB, Stockholm Sweden) system was evaluated by manual interpretation of 1,000 consecutive anonymous printouts of chest- and thumb-ECG waveforms, without any exclusion. The anonymized printouts contained three 10 s. strips of ECG at 25 mm/s, including mean heart rate, RR median and any user-provided annotation but with personal identification and algorithm analysis results blinded. The recordings were derived from actual Coala users with no training, control or influence, under a defined time period. The prevalence of cardiac conditions in the user population was unknown. The blinded recordings were manually interpreted by a trained cardiologist. The interpretation was compared with the automatic analysis performed by an enhanced algorithm in the Coala Cloud to evaluate ECG signal performance and to calculate performance metrics of a combination of sequential dual chest- and thumb-ECG measurements as compared to the clinical performance metrics of singe lead ECG measurements only. Results Metric Result using dual chest- and thumb-ECG and P-wave detection algorithm Result based on single lead thumb-ECG only Prevalence of AF in the recordings 14.4% (143 of 990 recordings) 14.4% (143 of 990 recordings) Percentage of recordings with ECG quality good enough to permit manual interpretation. 99,2% (8 of 998 non-readable) 98,7% (13 of 998 non-readable) Negative predictive value (NPV) for detecting AF 0.992 0.995 Positive predictive value (PPV) for detecting AF 0.872 0.647 False positive discovery rate 12.8% 35,3% Sensitivity for detecting AF 0.951 0.972 Specificity for detecting AF 0.976 0.909 Accuracy 0.973 0.919 Conclusion Based on 1,000 real-world recordings the combination of dual chest- and thumb-ECG with P-wave detection yielded significantly higher Positive Predictive Values as compared to single lead ECG measurements. Dual chest- and thumb-ECG reduced false positive AF indications from 35,3% for single lead-ECG to 12,8% using combined chest- and thumb-ECG with P-wave detection.