January 3, 2014
Zio Patch Beats Holter For Extended Tracking Of Heart Rhythm
redOrbit Staff & Wire Reports - Your Universe Online
A small adhesive wireless patch worn on the chest for up to two weeks is better at detecting abnormal and potentially dangerous heart rhythms than the Holter monitor, the gold standard of care for decades, the Scripps Translational Science Institute (STSI) reported Thursday in the American Journal of Medicine.
The researchers said the ZIO Service – which includes the FDA-approved ZIO Patch, data analysis and a diagnostic report provided by device maker iRhythm Technologies – could replace the Holter monitor as the preferred method of tracking electrical heart activity in ambulatory patients.
“This is the first large prospective validation that this new technology superseded the device invented by Norman Holter in 1949,” said the study’s senior author and cardiologist Eric Topol, MD, STSI director and chief academic officer of Scripps Health.
“By tracking every heart beat for up to two weeks, the ZIO Service proved to be significantly more sensitive than the standard Holter, which uses multiple wires and typically is only used or tolerated for 24 hours.
“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,” he said.
The ZIO Patch is a compact, low profile, noninvasive, water-resistant device that is worn for up to two weeks throughout normal activity, and then mailed by the patient to iRhythm for analysis with a proprietary algorithm. The Holter monitor, which was first introduced in the 1940s, includes a fist-sized recorder typically worn at the waist with up to seven lead wires that attach to the chest.
The STSI study used electrocardiograph data collected from 146 patients who were fitted with a ZIO Patch and a Holter monitor after being referred to the cardiac investigations laboratory at Scripps Green Hospital for ambulatory heart monitoring. The Holter monitor was worn for 24 hours, while the ZIO Patch was worn for up to 14 days.
The results showed that the ZIO Service detected 96 arrhythmia events while the Holter monitor detected 61, something the researchers mainly attribute to the patch’s prolonged monitoring.
Doctors who reviewed data from both devices reported attaining a definitive diagnosis 90 percent of the time when using the patch results, compared with 64 percent of the time when using Holter monitor data. Additionally, a survey of study participants found that 81 percent of them preferred wearing the patch over the Holter monitor, with 76 percent saying the Holter monitor affected their daily living activities.
One unexpected finding from the study was that the Holter monitor detected 11 more arrhythmias than the ZIO Service during the initial 24-hour period when both devices were working simultaneously. However, all of those arrhythmias were detected beyond 24 hours by the patch during the device’s extended monitoring period, and the ZIO Service detected two arrhythmias not captured by the Holter during the initial 24-hour period.
“On the basis of these findings, novel, single-lead, prolonged-duration, low-profile devices may soon replace conventional Holter monitoring platforms for the detection of arrhythmia events in patients referred for ambulatory ECG monitoring,” the study’s authors concluded.