Comparison of 24 h ECG Holter Monitoring with Real-time Long-term ECG Monitoring System using ECGalert Software and Savvy Single-Lead Patch

Abstract

AIM: The aim of the study was to show non-inferiority of the single-channel ECGalert system to the gold standard (ECG Holter) in the detection of arrhythmias over the total wear time of both devices.
 METHODS: A prospective study enrolled a total of 165 patients hospitalized at the University Clinic of Cardiology, who underwent simultaneous single-channel ECG recording with ECGAlert system and a conventional 24 h Holter monitor on the 1st day and continued ECGAlert monitoring for few more days, under assignment of the doctor or at the wish of the patient.
 RESULTS: A total of 165 patients were included in the study, 61.2% male, mean age of 58.4 ± 12.7 years. Mean duration of ECG Holter monitoring was 23.2 ± 0.5 h and mean duration of ECGalert/Savvy monitoring was 64.6 ± 31.2. During the first 24 h of simultaneous ECG monitoring with both methods, no statistically significant difference was found in arrhythmia detection. Over the total wear time of both devices, the ECGalert system detected significantly more AF episodes as compared to Holter (p < 0.000). ECGalert demonstrated significantly lower detection rate of false pauses (0.001). However, false detection of episodes of VT or AF was significantly higher in ECGalert system versus Holter (p < 0.000 and p < 0.000 respectively). Patients were more satisfied with ECGalert system, due to lesser interference in daily activities.
 CONCLUSION: The ECGalert system demonstrated superiority over traditional Holter monitoring in arrhythmia detection in the total monitoring period, but not in the first 24 h.