Feasibility and safety of a single patch-based device for 30 days of continuous, uninterrupted ambulatory ecg monitoring

FUNDING ACKNOWLEDGEMENTS: Type of funding sources: Private company. Main funding source(s): iRhythm Technologies, Inc. BACKGROUND: 14-day continuous ambulatory ECG monitoring (AEM) has been shown to have superior diagnostic yield to traditional 48-hour Holter monitoring for paroxysmal or undiagnosed atrial fibrillation and a wide range of clinical arrhythmias. 30-day recordings are typically from event recorders (non-continuous) and require frequent adhesive/electrode and battery replacement, all of which can impair patient compliance, wear time, and diagnostic yield. A new, uninterrupted patch-based AEM with next-generation breathable adhesive, storage, and battery life has received FDA clearance for 14-day wear. We evaluated the safety and feasibility of using this device for 30-days of continuous AEM. METHODS: We enrolled 30 participants with indications for AEM and applied a single Zio Monitor device for 30-days and analyzed wear time, analyzable time, and diagnostic yield, compared to with Zio Monitor 14-day use and with our standard, previous-generation product. RESULTS: In the cohort (76% female, 35% non-white, age 37±9 years, BMI 30.6±6.8), the median wear time was 29 continuous days (IQR 28-30) with no device changeouts and no clinically significant skin irritation. Although median analyzable times were high and similar across the previous (XT) and next-generation (Monitor) devices, the mean was significantly higher with Monitor, indicating fewer outliers that experienced premature termination of wear time. Arrhythmia yield (AF ≥30 sec, SVT ≥90 bpm & ≥4 bt, VT ≥100 bpm & ≥4 bt, inc PVT/TdP/VF, Pause ≥3 s, and/or AVB (any 2nd Deg or CHB) was significantly higher with the new Zio Monitor Device compared to Zio XT (80.9% vs 77.1%; p=0.017). CONCLUSION: The application of a single, continuous, patch-based AEM for 30 days without adhesive (electrode) or battery replacement is feasible and safe. Analyzable time was high for 14-day and 30-day wear. The uninterrupted wear time and high compliance could lead to higher diagnostic yield than with traditional 30-day event recorders. [Figure: see text]