Skin-patch device for ambulatory monitoring.
Patients referred to the cardiac investigations laboratory at Scripps Green Hospital, La Jolla, Calif., between April and July 2012 were fitted simultaneously with a 24-hour Holter monitor and a Zio Patch, which is a lightweight, single-use electrocardiographic (ECG) device that was attached over the left pectoral region of the patient's chest by an adhesive patch. Patients wore the patch for a median of 11 days, but it can be worn for as long as 14 days.
Among 102 physicians surveyed in the study, 90% said they thought that the data from the patch provided a definitive diagnosis, compared with 64% who thought the Holter data allowed a definitive diagnosis, Dr. Paddy M. Barrett and his associates reported (Am. J. Med. 2014;127:95.ell-95.el7).
Patients showed a clear preference for the water-resistant patch, saying that it affected just 10% of their activities of daily living, compared with 76% of activities affected by the Holter monitor. The patch was comfortable to wear, according to 94%, and 52% said the Holter monitor was comfortable. Asked to choose between the two, 81% of patients said that they preferred the patch.
Researchers applied the patch, but, outside of the study, it sometimes is mailed directly to a patient for self-application. Patients can press a button on it to indicate when they feel symptoms. At the end of the monitoring period, the patch is mailed to an iRhythm facility for data analysis, from which a digital report is sent to the ordering physician. The Zio Patch is approved by the Food and Drug Administration.
During the first 24 hours when both devices were worn in the study, the Holter monitor detected 11 arrhythmic events not detected by the patch, but these and more were found during the extended use of the patch. A review of those 11 events led to an adjustment in the device's algorithm and extra training for the staff who review the data and produce the reports for clinicians, according to Dr. Barrett, who led the study while he was a fellow at Scripps Translational Science Institute, La Jolla, and now is a cardiology fellow at St. Vincent's University College Hospital, Dublin.
Six arrhythmias were included in the definition of arrhythmic events: supraventricular tachycardia; atrial fibrillation/flutter; a pause greater than 3 seconds; atrioventricular block; ventricular tachycardia; or polymorphic ventricular tachycardia/ventricular fibrillation.
In an interview, Dr. Barrett expressed particular interest in the device's ability to detect asymptomatic atrial fibrillation that commonly is missed by 24-hour Holter monitoring. "The detection of more [events] allows risk stratification and implementation of treatment strategies," he said. The investigators have no plans to conduct a long-term study to see if the incremental diagnoses obtained by the patch ultimately improve health outcomes.
The list price of the Zio device and service is $595, according to a spokeswoman for iRhythm Technologies, which markets the Zio. Dr. Barrett said the cost is roughly comparable to that of 24-hour Holter monitoring and less expensive than other forms of extended ECG monitoring. Most insurers will cover the Zio Patch. Aetna, one of the largest U.S. insurance companies, began covering the Zio Patch for long-term ECG monitoring in January 2014.
iRhythm Technologies helped fund the studies. Dr. Barrett reported having no financial disclosures.
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|Title Annotation:||EVIDENCE-BASED APPS|
|Publication:||Family Practice News|
|Date:||May 15, 2014|
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