A new study from the Scripps Translational Science Institute, , shows that iRhythm's Zio patch, a wireless adhesive heart monitor patch, detects more arrhythmia events than a traditional Holter monitor and provides a better experience for patients.
The study of 146 patients with mild atrial fibrillation compared the two devices over the length of time they were designed to be worn -- 24 hours for the Holter monitor, a mobile phone-sized device worn at the waist and connected to the patient via multiple lead wires and two weeks for the Zio patch, a smaller adhesive device worn on the patient's chest. The Zio patch does not have any sort of connectivity -- the readings are simply stored in the water-resistant device, which the patient mails to iRhythm at the end of the monitoring period.
"What I like about [the Zio patch] is you're getting the person more in the wild, more in their natural state," lead author Dr. Eric Topol told Babyforyou.net.ua. "And you actually want to encourage patients to exercise with the band-aid on them. You're getting almost a stress test. You can't get that with a Holter."
The Zio patches detected 96 arrhythmia events over two weeks of monitoring, whereas the Holter monitors detected 61. For the initial 24 hours when both monitors were worn, the Holter monitor detected 11 arrhythmias missed by the Zio patch, but the Zio patch picked them up over the remaining time. The study data suggests that the arrhythmia events missed by the patch were mostly due to algorithm errors which could be corrected in future versions of the patch.
Both doctors and patients preferred the Zio patch. Doctors who looked at data from both devices said they reached a definitive diagnosis 90 percent of the time when using the patch results and 64 percent of the time when using Holter monitor data. A survey of participants, meanwhile, 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.
"I'm thinking the Holter monitor has had a long course, since 1949, and it might be on the way out," said Topol. "The Holter monitor is very obtrusive for patients. You really can't have normal function for that period of time. You can't take a shower, you can't exercise. It's not a very good device and moreover, you have to have the patient come to the hospital to get a formal hook-up procedure and disconnect and there's a fee for that. It's antiquated technology and the time has come to say 'we can do better'."
Topol said that even if additional studies show that devices like the Zio patch outclassing the Holter monitor, the switch over won't be able to scale until doctors and patients are ensured of reimbursement for this kind of technology.
"These are really inexpensive to make," he said. "The question is, can these be more palatable for patients, but also for a fraction of the cost we would attribute to a Holter monitor? [...] It's disruptive and challenging to the current reimbursement system. The current model is the Holter, and the question is 'Can we come up with a whole new model?'"
Topol said Scripps is also in the process of using the Zio patch in another study, comparing results from the patch to genomic data in patients who have a high risk of atrial fibrillation or have had a stroke with an unknown cause. The FDA-cleared Zio patch has previously been used in a study by the California Health Care Foundation.