Use of a Noninvasive Continuous Monitoring Device in the Management of Atrial Fibrillation: A Pilot Study

Michael A Rosenberg,Peter J Zimetbaum,Michelle Samuel,Amit Thosani

doi:10.1111/pace.12053

Michael A Rosenberg, Peter J Zimetbaum + Show 2 more

Open Access

https://doi.org/10.1111/pace.12053

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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

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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Results

Conclusion