HRX 2024 AbstracX Library-Performance of a Novel Next-Generation Ambulatory ECG Long-Term Patch Monitor: A Multicenter Post-Market Evaluation

Performance of a Novel Next-Generation Ambulatory ECG Long-Term Patch Monitor: A Multicenter Post-Market Evaluation

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The document presents a multicenter post-market evaluation of a next-generation patch-based ambulatory ECG monitor, specifically the Zio Monitor, in comparison to the older Zio XT device. The study was led by a team of researchers and conducted across various institutions including Northwestern University, iRhythm Technologies, Cleveland Clinic, and Valley Health System. The primary focus of the study was to assess the clinical performance and utility of the newer device in monitoring ambulatory ECGs.<br /><br />Key findings from the evaluation highlight that the Zio Monitor consistently outperformed the Zio XT device in several metrics. The Zio Monitor demonstrated a longer wearable duration with an average of 12.6 days compared to 11.9 days for the Zio XT. Additionally, there was a notable reduction in early discontinuation rates with the Zio Monitor (1.1% vs 2.8%), suggesting improved patient compliance.<br /><br />Signal quality assessments revealed that the Zio Monitor had a higher analyzable time, offering an average of 12.2 days of usable data compared to 11.5 days for the Zio XT. It also achieved a higher percentage of analyzable ECG data, indicating superior signal quality. Skin irritation reports were significantly lower for the Zio Monitor at 0.47% compared to 1.35% with the Zio XT, which may contribute to improved user comfort and extended use.<br /><br />In terms of rhythm detection, the Zio Monitor showed a higher arrhythmia yield of 80.9% compared to 76.4% for the Zio XT, demonstrating its enhanced diagnostic capability for arrhythmias such as atrial fibrillation (AF). Overall, these findings point to the improved performance and clinical utility of the Zio Monitor, emphasizing the benefits of integrated design updates in medical devices. Further validation in real-world settings is suggested to confirm these results.

Keywords

Zio Monitor

Zio XT

ambulatory ECG

arrhythmia detection

clinical performance

patient compliance

signal quality

skin irritation

atrial fibrillation

medical devices