A Novel Patch for Heart Rhythm Monitoring

Future Perspective

From a technological standpoint, the miniaturization of the Holter monitor concept was long overdue. In the author's opinion, there is little, if any, clinical advantage of the Holter monitor over newer technologies such as the Zio Patch. Once the reimbursement hurdles are overcome, it is possible that the Zio Patch concept may have the potential to replace the 60 year-old Holter monitor entirely.^[2,6] Furthermore, given that the Zio Patch records for a sufficiently long period of time in order to capture most intermittent arrhythmias, with yields that seem to be similar to other longer-term monitors, the Zio Patch has the potential to replace, and be a more cost-effective monitoring solution than other event monitors and MCOT devices. For many outpatients, compliance, ease-of-use and an optimal monitoring test are more important than real-time monitoring.

Further advances in the iRhythm Zio Patch are currently under development, including a slimmer profile and a more cost-effective manufacturing process.^[102] The technology is presently available for recordings with a longer duration than 14 days. Of course, the delay in analysis inherent with longer application has resulted in diminished interest. At present, such scenarios may be handled by removal after 14 days and reapplication of serial patches when appropriate. Others are working on a real-time leadless patch type monitor using cellular technology. Finally, it is hoped that removal of regulatory hurdles resulting in the requirement for physician prescription could permit greater access to presently available heart rhythm recording tools, including the Zio Patch and the smart-phone ECG recorder.

Another vendor has developed a different patch concept able to monitor vital signs, including heart rate, temperature, activity and body fluids.^[111] NASA has funded research with subsequent commercial application utilizing microwave radar for noninvasive vital sign detection.^[13] Defense research is developing systems that will allow remote vital sign detection, even through the wall of a room. Today, sensor systems are available to confirm medication compliance and in-home activity levels. Potentially, such technology could support solitary elderly people remaining in their homes.^[14]

In the current regulatory and reimbursement environment, the traditional health insurance model is often found lacking. Thus, payment for such novel concepts may also be novel, perhaps coming from the defense industry (research on new monitoring devices), retirement funds (assisted living alternatives) or direct-to-consumer demands, rather than traditional health insurance. Would you be willing to pay for remote cardiac monitoring of loved ones?

Disclaimer
The opinions expressed in this article are those of the author and do not necessarily reflect the views of Future Medicine Ltd.

Acknowledgements
The author would like to acknowledge the assistance of UN Kumar in the review of this manuscript.

Table 2. Comparison of major differences between the Zio® Patch and Holter monitor.
Heart monitor	Average typical use (days)	Longest typical use (days)	Number of ECG channels (typical use)	Physician over-reading	Rhythm analysis	Ref.
Zio® Patch	7–10	14	1	Yes	Proprietary at manufacturer	[2,6]
Holter	1	2	2	Yes	Using software by trained office-based medical assistants	[1,7]

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Executive Summary

Alternative Rhythm Recording Options

Presently available noninvasive rhythm recording options include the ECG, the Holter monitor, the event recorder or loop monitor, and real-time mobile outpatient cardiac telemetry.
Invasive rhythm evaluation options include the implanted loop recorder and cardiac electrophysiologic study, with or without a subsequently implanted cardiac electrical device such as a pacemaker or defibrillator.
New options available just in the past year include an iPhone ® (Apple, CA, USA) hardware add-on that can record rhythm strips live, as well as handheld heart rhythm recording devices, both to be used for symptomatic episodes only.

Use of the Zio ® Patch in an Ambulatory Setting

The Zio ® Patch (iRhythm Technologies, Inc., CA, USA) is a 2 × 5-inch band-aid like device that adheres to the upper chest and can continuously record up to 14 days of a single-channel ECG.
A retrospective clinical trial, completed in 2012, confirmed ease-of-use of the Zio Patch in an outpatient evaluation postemergency department visit, where 100% of patients returned their devices for rhythm review, recording an average of over 7 days of heart monitoring.

Acceptance Hurdles

Despite US FDA approval, the Zio Patch has met slow acceptance possibly due to reimbursement hurdles.
Explanations for the slow acceptance include a challenging regulatory environment and a general reluctance for compensation for new medical devices. Some physicians are adopting the Zio Patch as a loss-leader, absorbing the expense.

SuddenLife: A Consumer Health Alternative

A novel model utilizing the Zio Patch technology is presented for use outside of the traditional health insurance system, requiring direct payment from the patient.
This new concept allows screened patients to have their long-term cardiac recordings analyzed by a cardiologist with patient-specific written recommendations. This consumer health model may be attractive to those interested in a heart rhythm diagnostic evaluation, without the need for an in-office physician visit, at least until a diagnosis is made.

Future Perspective

Future advances include improvements in current technology, as well as defense- and aerospace-funded research into remote vital sign monitoring.
If reimbursement hurdles can be overcome, the traditional wired Holter monitor may be replaced by newer technologies, such as the Zio Patch.

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