New Drugs and Devices From 2011 – 2012 That Might Change Your Practice

Joe Lex, MD

Disclosures

Western J Emerg Med. 2013;14(6):619-628. 

In This Article

Zio-patch®

In 1946, a physicist/chemist named Norman Jefferis "Jeff" Holter returned to his home of Helena, Montana, to establish a research lab after serving in the U.S. Navy Bureau of Ships and researching the behavior of waves. One of his early inventions was a device that still bears his name: the Holter monitor. In those pre-transistor days, the device was the size of a very large backpack and weighed about 85 pounds. The size of recorder varies among manufacturers, but the average dimensions of today's Holter monitors are about 110x70x30 mm. Most of them operate with two AA batteries and record a continuous period of 24 to 48 hours. The first report of Holter monitoring in humans appeared in 1954 by MacInnis. If you go to PUBMED now and search "Holter monitor," you will find more than 11,000 references.

The Zio® Patch is a single-use, noninvasive, waterproof, long-term continuous monitoring patch worn on the chest that provides continuous monitoring for up to 14 days. Theoretically by providing a longer time period of continuous recording, the Zio® Patch improves the likelihood of capturing arrhythmias and provides for an equal or higher diagnostic yield versus other devices on the market. Thus far there is very little literature on this device, but initial investigators gave it glowing reviews. While the authors acknowledged receiving a restricted research grant from the manufacturer iRhythm, they stated there were no conflicts of interest.

In their study they compared the Zio® Patch to a 24-hour Holter monitor in 74 consecutive patients with paroxysmal atrial fibrillation referred for Holter monitoring for detection of arrhythmias. The Zio® Patch allowed 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 atrial fibrillation events and estimating atrial fibrillation burden. Atrial fibrillation events were identified in 18 additional individuals in the Zio® Patch group, prompting therapy change. Other clinically relevant cardiac events recorded on the Zio® Patch after the first 24 hours of monitoring included symptomatic ventricular pauses, which prompted referrals for pacemaker placement or changes in medications.

The patient can remove the patch after the observation time and mail it back to the physician. Cost is about $150 per patch, considerably less than the cost of Holter monitoring. I predict that when these become freely available, emergency physicians will jump at the opportunity to use them. Think about the number of patients we see complaining of palpitations or similar symptoms and how difficult it is to arrange a Holter monitor from the ED. With the Zio® Patch, we take a Band-Aid®-sized device out of its package and slap it on the patient's chest and give them instructions about what to watch for and who to follow up with.

On the other hand, as with any innovative new device I worry about the "technological imperative," also known as "the inevitability thesis." Simply stated, "whatever can be done will be done," or, to put it more bluntly, "once you are handed a hammer, everything starts to look like a nail." Will we save lives with this device, or will we pick up "incidentalomas" that condemn patients to a lifetime of medication or, worse yet, internal defibrillators and pacemakers because now we can identify trivial problems that may never cause a symptom. Will we make our patients VOMIT (Victims Of Medical Investigational Technology)? We'll have to see.

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