This study demonstrates that significant differences in diagnostic yield exist between these two seemingly similar patch ambulatory ECG monitors applied during the same 7-day monitoring period and that these differences can impact clinical decision making."ĭr. The ability to accurately detect P-waves during an arrhythmia event allows physicians to make a more specific and confident rhythm diagnosis. The clarity of an ECG signal is important in providing the ability to see P-waves during a recorded arrhythmia. AEM diagnostics and ECG clarity vary with electrode location, signal noise, signal processing technology, and electronic design. Although duration of recording improves arrhythmia diagnosis, a very important factor is the clarity of the ECG recording. Rho commented "Most innovations in AEMs have focused on increased monitoring duration. Importantly, it was found that the superior signal clarity provided by the CAM patch may result in more informed clinical decisions in over a third of the patients.ĭr. Both devices were considered user-friendly however, the CAM patch was observed to be slightly easier to attach and remove, more stable, and associated with less skin reaction. ECG clarity was ranked as "high" in all CAM reports compared to the Zio XT reports (100% versus 16%, p<0.001). The CAM patch identified more arrhythmias (particularly atrial tachycardia, atrial flutter, and non-sustained VT) than the Zio XT patch in contrast to atrial fibrillation, where both monitors performed adequately. The study evaluated the differences in specific rhythm diagnosis and ECG clarity between the two commercially available patch AEMs. The outcome measures were to compare diagnostic yield, ECG signal clarity, ease of use and comfort, and, importantly, an assessment of differences in clinical decision-making based upon each device's rhythm diagnosis. At the end of the monitoring period, the patches were removed at the same visit. In the prospective time-paired comparative study led by electrophysiologist Robert Rho, MD, FHRS, FACC, 30 patients simultaneously wore a pectorally-placed arrhythmia monitoring patch (iRhythm Technologies, Zio XT patch) and a P-wave centric arrhythmia monitoring patch (Bardy Diagnostics, CAM patch) placed over the sternum with the intent of recording for 7 days. The study, " Comparison of two ambulatory patch ECG monitors: The benefit of the P-wave and signal clarity" concluded that the BardyDx CAM single-channel patch ambulatory ECG monitor (AEM), designed specifically to enhance P-wave detection, identified significantly more arrhythmias and resulted in better, more informed clinical decision-making over the iRhythm Zio ® XT patch. SEATTLE, WA - Bardy Diagnostics, Inc., ("BardyDx"), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, including the Carnation Ambulatory Monitor ("CAM™"), the world's only P-wave centric™ ambulatory cardiac monitor and arrhythmia detection device, announced today that the American Heart Journal has published the results of a head-to-head comparison of two patch-based arrhythmia monitoring systems. Bardy Diagnostics™ Announces Results of Head-to-Head Comparison of Patch-Based Arrhythmia Monitors
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