New research indicates a wireless device could do a better job than the Holter monitor, the standard of care for mobile heart rhythm monitoring over the past half-century.
The Scripps Translational Science Institute compared the Holter monitor with the ZIO Patch, an FDA-cleared, non-invasive, water-resistant device worn on the chest for up to two weeks. STSI, based in San Diego, compared electrocardiograph data from 146 Scripps Green Hospital ambulatory care patients who were fitted with both the ZIO Patch and a Holter monitor.
In all, researchers said, the ZIO Patch, developed by San Francisco-based iRhythm, identified 96 arrhythmia events, while the Holter monitor detected 61.
“This is the first large prospective validation that this new technology superseded the device invented by Norman Holter in 1949,” said Eric Topol, MD, chief academic officer at Scripps Health and STSI's director.
Topol, a cardiologist and lead author of the study, continued in a prepared statement that over the course of tracking every heartbeat for two weeks “the ZIO Service proved to be significantly more sensitive” than the Holter, which consists of a cellphone-sized recorder usually worn about the waist and five to seven lead wires attached to the chest and can only be worn for 24 hours at a time.
“For millions of people who present each year with suspected arrhythmia, this may prove to be the new standard for capturing the culprit heart rhythm electrical disturbance, most commonly atrial fibrillation which carries a significant risk of stroke,” Topol added.
According to STSI officials, physicians analyzing data from both monitors reached a "definitive diagnosis" 90 percent of the time with the ZIO Patch but only 64 percent of the time with the Holter monitor. In addition, 81 percent of the survey participants reported liking the ZIO Patch over the Holter monitor, with 76 percent suggesting that the Holter monitor was obtrusive.
The STSI study also noted that the Holter monitor detected 11 more arrhythmias than the ZIO Patch during the first 24 hours, when both devices were worn at the same time. Those arrhythmias were eventually detected beyond the 24 hours by the ZIO Patch, as were two more arrhythmias not picked up by the Holter monitor during its 24 hours of operation.
The study was funded by iRhythm Technologies and an award made to STSI by the National Institutes of Health.