Abstract

BackgroundOutpatient ambulatory cardiac rhythm monitoring is a routine part of the management of patients with paroxysmal atrial fibrillation (AF). Current systems are limited by patient convenience and practicality.MethodsWe compared the Zio® Patch, a single-use, noninvasive waterproof long-term continuous monitoring patch, with a 24-hour Holter monitor in 74 consecutive patients with paroxysmal AF referred for Holter monitoring for detection of arrhythmias.ResultsThe Zio® Patch was well tolerated, with a mean monitoring period of 10.8 ± 2.8 days (range 4–14 days). Over a 24-hour period, there was excellent agreement between the Zio® Patch and Holter for identifying AF events and estimating AF burden. Although there was no difference in AF burden estimated by the Zio® Patch and the Holter monitor, AF events were identified in 18 additional individuals, and the documented pattern of AF (persistent or paroxysmal) changed in 21 patients after Zio® Patch monitoring. Other clinically relevant cardiac events recorded on the Zio® Patch after the first 24 hours of monitoring, including symptomatic ventricular pauses, prompted referrals for pacemaker placement or changes in medications. As a result of the findings from the Zio® Patch, 28.4% of patients had a change in their clinical management.ConclusionsThe Zio® Patch was well tolerated, and allowed significantly longer continuous monitoring than a Holter, resulting in an improvement in clinical accuracy, the detection of potentially malignant arrhythmias, and a meaningful change in clinical management. Further studies are necessary to examine the long-term impact of the use of the Zio® Patch in AF management.

Highlights

  • Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, and its prevalence in the population is increasing.[1]

  • We examine a novel outpatient ambulatory cardiac rhythm monitoring device called the Zio R Patch, a single-use, noninvasive waterproof long-term continuous monitoring patch, capable of continuously monitoring for up to 14 days, and compare its use with that of the 24-hour Holter monitor in the management of patients with AF

  • The rhythm data were collected on the device, and after the device was received by the manufacturer, the data were analyzed using the manufacturer’s Food and Drug Administration (FDA)-cleared proprietary algorithm and underwent technical review for report creation and quality assurance, after which the report was uploaded to a secure website, where it was reviewed by cardiologists on the investigation team

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Summary

Introduction

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, and its prevalence in the population is increasing.[1] Treatment of AF, regardless of the etiology, is a heavy burden on the healthcare system, with annual U.S costs for AF management $6.65 billion total, with $2.93 billion for hospitalizations alone.[2] Due to the frequency of asymptomatic episodes,[3,4] outpatient ambulatory cardiac rhythm monitoring is an integral part of the management of paroxysmal. Outpatient ambulatory cardiac rhythm monitoring is a routine part of the management of patients with paroxysmal atrial fibrillation (AF). Current systems are limited by patient convenience and practicality

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