Electrocardiographic patch devices and contemporary wireless cardiac monitoring

Abstract

Cardiac electrophysiologic derangements often coexist with disorders of the circulatory system. Capturing and diagnosing arrhythmias and conduction system disease may lead to a change in diagnosis, clinical management and patient outcomes. Standard 12-lead electrocardiogram (ECG), Holter monitors and event recorders have served as useful diagnostic tools over the last few decades. However, their shortcomings are only recently being addressed by emerging technologies. With advances in device miniaturization and wireless technologies, and changing consumer expectations, wearable "on-body" ECG patch devices have evolved to meet contemporary needs. These devices are unobtrusive and easy to use, leading to increased device wear time and diagnostic yield. While becoming the standard for detecting arrhythmias and conduction system disorders in the outpatient setting where continuous ECG monitoring in the short to medium term (days to weeks) is indicated, these cardiac devices and related digital mobile health technologies are reshaping the clinician-patient interface with important implications for future healthcare delivery.

Keywords: ambulatory patients; arrhythmias; cardiac; conduction system disorders; electrocardiography; healthcare delivery; medical devices.

Figure 1

Contemporary options for cardiac monitoring. The range of options for outpatient cardiac monitoring varies depending on the intended study duration, the presence or absence of symptoms, the need for continuous deployment (solid line with arrows) vs. intermittent symptom-triggered monitoring, ability of the subject to activate or initiate recording, likelihood of study completion specific to device design, and lifestyle (e.g., hindrance to work and activities, need for water resistance, ability to tolerate presence of device). Dashed line with arrow indicates serial deployment of multiple patch devices to achieve a study period of 30 days. ICD, implantable cardioverter defibrillator. ICM, injectable cardiac monitor. ILR, implantable loop recorder. PPM, pacemaker. ^*Manual contact and triggering required for intermittent activation or operation. ^§Superseded by SEEQ MCT.

Figure 2

A selection of contemporary wireless mobile cardiac monitoring devices. Two leading AECG adhesive patch devices on the medical device market today are (A) second-generation ZIO® XT Patch by iRhythm Technologies, Inc. and (B) SEEQ™ MCT patch device by Medtronic, Inc. (cellular transmitter not shown). Featuring touch-activable electrodes configured for the Apple iPhone or Androidbased systems are (C) third-generation AliveCor® by AliveCor, Inc. and (D) ECG Check by Cardiac Designs, LLC. As the first-in-class injectable cardiac monitor, (E) Reveal LINQ™ (4.0 × 7.2 × 44.8 mm; 2.4 g) by Medtronic, Inc. can record rhythm data for up to 3 years.