Researchers at Scripps Translational Science Institute in La Jolla, California found a small adhesive patch worn over the heart outperformed the conventional Holter monitor in detecting abnormal heart rhythms. The team led by Scripps cardiologist Eric Topol published its findings online in this month’s issue of the American Journal of Medicine.
Topol and colleagues tested the Zio patch system made by iRhythm, a medical device company in San Francisco, against the conventional Holter heart monitor. The Zio system has a monitor chip, secured with water-resistant adhesive to the chest of the patient, which is worn for up to 14 days. The patch collects heart rhythm data and detects irregular rhythms, such as those indicating atrial fibrillation, a common problem that can lead to pooling of blood in the heart and increase the risk of a stroke.
After being worn by the patient, the Zio patch is sent back to iRhythm, where technicians analyze the data and highlight potential problems for the patient’s doctor to review. Both the patch and the analytical system received FDA clearance in 2009. A prescription is required for a patient to use the system.
A Holter heart monitor collects heart rhythm data through several electrodes attached to the chest and wired to a battery-powered recording device about the size of a smartphone. The Holter monitor continuously records heart beats for 24 to 48 hours, also detecting irregular rhythms, and is then returned to a technician for data download and analysis.
Biophysicist Norman Holter created an early version of the monitor in the 1940s, and received a U.S. patent for the device in 1965. Holter collaborated with Del Mar Engineering Laboratories to build the current heart monitoring device that became the state of the art for more than 40 years.
The Scripps team recruited 146 patients from nearby Scripps Green Hospital who were referred for ambulatory heart monitoring. The patients wore both the Zio patch for 14 days and the Holter monitor for 24 hours, then returned the devices for data download and analysis. In their analysis, independent physicians looked for six different types of heart rhythm problems.
The Zio system was found to detect more heart problems than the Holter monitor, with Zio finding 96 irregular heart rhythm events over the 14 days and the Holter monitor recording 61 events during the 24 hours it was worn. During the 24-hour period when both devices were worn, the Holter monitor picked up 11 more problem events than Zio, but the patch system later detected all of these 11 events. The Zio system also recorded two problem events not detected by the Holter monitor during the 24-hour period when both devices were worn.
Scripps Translational Science Institute is a collaboration between Scripps Research Institute and Scripps Health, a health care provider serving southern California, and funded in part by National Institutes of Health. Topol is the institute’s director.
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