Similarly, in selected patients, the opportunity to document a significant arrhythmia may preclude the need for inpatient hospitalization. Patients who have symptoms such as palpitations yet are documented to not have a significant concurrent arrhythmia potentially do not need the expense of consultation with a cardiac rhythm specialist. In addition, the potential for cost savings to the healthcare system are, in the author's opinion, evident. Table 2 further summarizes the differences between the Holter monitor and Zio Patch. A second head-to-head randomized comparison for all symptomatic indications has just been completed, with results expected in late 2013.
Zio heart monitor results Patch#
The authors found more than 28% of patients had changes in their clinical management for atrial fibrillation as a result of the longer duration of the Zio Patch recording. Due to the longer duration of Zio Patch recordings, more cardiac events were recorded, which translated to a statistically significant change in clinical decision management. During the simultaneous recording time, where the patients wore both devices, a strong correlation between the two modalities was noted (r = 0.96). It compared the Zio Patch with applications for a mean time of 10.8 ± 2.8 days with the traditional 24-h Holter monitor. Of the 45% who had a symptomatic arrhythmia, the average time to first symptomatic arrhythmia was 3.2 days (SD: 1.3 maximum: 10.7).Ī prospective comparison of Holter monitors with the Zio Patch was recently published online, to be printed in 2013. Many (55%) of the symptomatic patients were found to not have a significant concurrent arrhythmia, defined as an arrhythmia within 90 (±45) s of activation of the trigger marker. Palpitations (28%) and syncope (16%) were the most common indications for patch application. The average wear time was 7.2 days (SD: 3.5 maximum: 14). Of the 285 patients enrolled, all 285 (100%) returned their devices by mail for analysis. The concept was well accepted by the ED patient population. Upon completion of the monitoring, retrospective data analysis was performed.
Briefly, we deployed the FDA-approved Zio Patch products in three large suburban emergency departments (EDs), permitting the ED physician to prescribe at his or her discretion. We presented a retrospective analysis of the rhythm monitor in 2011. The iRhythm Zio Patch was cleared by the FDA for use only by physician prescription using the 510(k) pathway as the product was deemed 'substantially equivalent' to predicate devices. Use of the Zio Patch in an Ambulatory Setting
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