Wireless adhesive patch challenges Holter heart rhythm monitor

For more than half a century, physicians have relied on a portable device called the Holter monitor to record patients' heart activity as they go about their everyday activities. However, according to a blog post by National Institutes of Health Director Francis Collins, M.D., Ph.D., a wireless adhesive patch designed to monitor the heart's rhythms could replace this traditional technology.

In the blog, Collins discusses the results of a clinical trial published this month in which NIH-funded researchers from the Scripps Translational Science Institute, in La Jolla, Calif., compared the arrhythmia-detecting abilities of the Holter monitor with that of the new Zio Patch, an FDA-cleared wireless adhesive device made by San Francisco-based iRhythm Technologies. A total of 146 patients referred for evaluation of cardiac arrhythmia underwent simultaneous ambulatory ECG recording with a conventional 24-hour Holter monitor and a 14-day adhesive patch monitor. 

During the first 24 hours, the Holter detected nearly 15 percent more arrhythmia events than the adhesive patch, Collins found. But, because patients found wearing the adhesive patch for a longer period of time more tolerable (about 11 days on average) the new device could detect a significantly greater number of arrhythmia events (96) than was the Holter (61), Collins wrote.

"Pretty amazing stuff, but it will take a lot more than sheer ingenuity to move these devices from the inventor's bench into the real-world settings," writes Collins. "...A new health gadget may sound cool, but you'd want to know that it's been shown to produce better health outcomes before you invest your money (and maybe even your life) in it."

"Another challenge that calls for research is how to maintain the privacy and security of mHealth data. How do we protect trial participants and ordinary consumers without adversely affecting research and quality of care? Who will set rules for mHealth data?" he adds. "All of these are crucial issues to think about as we move ahead into this exciting new era of digital, personalized healthcare."

Last month, an article in the peer-reviewed journal Medical Devices: Evidence and Research reported the results of an observational study of more than 200,000 cardiovascular patients which demonstrated significant in-hospital cost savings in the 12 months following diagnosis using mobile cardiac telemetry (MCT), a small sensor and monitor that patients wear daily. 

The study's most significant finding was the level of cost savings per patient in cardiovascular in-hospital costs when an MCT was used versus either an event or Holter monitor. The study shows that the substitution of the MCT for an event or Holter monitor provides a 10 to 15 times return on investment in the first 12 months post-utilization.

"Given the superior outcome of MCT regarding both patient care and hospital savings, hospitals only stand to gain by enforcing protocols that favor the MCT system over the Event or the Holter monitor," the article's authors concluded.

To learn more:
- read the NIH blog post

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