Initial real world and clinical experience of the next generation ambulatory ecg zio monitor: implications for standard and extended wear monitoring

Abstract 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.

/pdf/feasibility-and-safety-of-a-single-patch-based-device-for-30-r53z0d11.pdf

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

Placebos are medical interventions that falsely lead patients to believe that they are receiving treatment and that their condition is being changed, when truly no specific treatment is being administered. Using placebos in research involving terminal illnesses has become debatable. While a placebo could potentially give way to new treatments, through testing alongside a specific drug in a clinical trial, the placebo itself may fail and the patient is not cured leading to possible fatality. It has been found that using placebos in research, like performing surgeries, can aid in medical or clinical research and could help our society financially by discouraging unnecessary operations. On the other hand, there are also risks involved, including the health risks that may result from the placebocontrolled trial, and most importantly the justification and ethics of using placebos on patients without their consent. While evaluating several studies involving placebo-induced treatments, we have discovered methods in which placebos can help society; although these helpful means can also raise issues regarding one’s ethics. Using placebos in treatments will not necessarily treat the illness itself, but they can be beneficial towards research in discovering new treatments for terminal illnesses.

/pdf/using-placebos-in-research-involving-terminal-illnesses-54rflafo8t.pdf

Using placebos in research involving terminal illnesses

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Initial real world and clinical experience of the next generation ambulatory ecg zio monitor: implications for standard and extended wear monitoring

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

Using placebos in research involving terminal illnesses