News | ECG Monitoring Services | May 08, 2018

BardyDx CAM Ambulatory ECG Monitor Patch Detects More Arrhythmias in Head-to-Head Study

Seven-day monitoring period reveals greater ECG signal clarity compared to Zio XT patch

BardyDx CAM Ambulatory ECG Monitor Patch Detects More Arrhythmias in Head-to-Head Study

May 8, 2018 — Bardy Diagnostics Inc. (BardyDx) announced that the American Heart Journal has published the results of a head-to-head comparison of two patch-based arrhythmia monitoring systems. The study, "Comparison of two ambulatory patch ECG monitors: The benefit of the P-wave and signal clarity,"[1] concluded the BardyDx CAM single-channel patch ambulatory ECG monitor (AEM), designed specifically to enhance P-wave detection, identified significantly more arrhythmias and resulted in better, more informed clinical decision-making over the iRhythm Zio XT patch.

In the prospective time-paired comparative study — led by electrophysiologist Robert Rho, M.D., FHRS, FACC — 30 patients simultaneously wore a pectorally-placed arrhythmia monitoring patch (iRhythm Technologies, Zio XT patch) and a P-wave centric arrhythmia monitoring patch (Bardy Diagnostics, CAM patch) placed over the sternum with the intent of recording for 7 days. At the end of the monitoring period, the patches were removed at the same visit. The outcome measures were to compare diagnostic yield, ECG signal clarity, ease of use and comfort, and an assessment of differences in clinical decision-making based upon each device's rhythm diagnosis.

The study evaluated the differences in specific rhythm diagnosis and ECG clarity between the two commercially available patch AEMs. The CAM patch identified more arrhythmias (particularly atrial tachycardia, atrial flutter and non-sustained VT) than the Zio XT patch in contrast to atrial fibrillation, where both monitors performed adequately. ECG clarity was ranked as "high" in all CAM reports compared to the Zio XT reports (100 percent versus 16 percent, p<0.001). Both devices were considered user-friendly; however, the CAM patch was observed to be slightly easier to attach and remove, more stable and associated with less skin reaction. It was found that the superior signal clarity provided by the CAM patch may result in more informed clinical decisions in over a third of the patients.

Rho commented, "Most innovations in AEMs have focused on increased monitoring duration. Although duration of recording improves arrhythmia diagnosis, a very important factor is the clarity of the ECG recording. AEM diagnostics and ECG clarity vary with electrode location, signal noise, signal processing technology and electronic design. The clarity of an ECG signal is important in providing the ability to see P-waves during a recorded arrhythmia. The ability to accurately detect P-waves during an arrhythmia event allows physicians to make a more specific and confident rhythm diagnosis. This study demonstrates that significant differences in diagnostic yield exist between these two seemingly similar patch ambulatory ECG monitors applied during the same 7-day monitoring period and that these differences can impact clinical decision making."  

The patch-to-patch comparison study builds on a study conducted by Warren Smith, MBChB, comparing the BardyDx CAM patch and a traditional Holter monitor, also in a simultaneous, paired assessment. That study demonstrated that the BardyDx CAM "resulted in a significantly improved rhythm diagnosis and avoided inaccurate diagnoses made by the standard three-channel Holter monitor" on a time-controlled basis.

The updated version of the CAM is called the Carnation. 

For more information: www.bardydx.com

 

Reference:

1. Robert Rho, Mark Vossler, Susan Blancher, et al. Comparison of two ambulatory patch ECG monitors: The benefit of the P-wave and signal clarity. American Heart Journal. DOI: https://doi.org/10.1016/j.ahj.2018.03.022

 

Related Content

HHS Releases Second Edition of Physical Activity Guidelines for Americans
News | Cardiac Diagnostics | November 14, 2018
The U.S. Department of Health and Human Services (HHS) released the second edition of the Physical Activity Guidelines...
ACC and AHA Release Updated Cholesterol Guidelines for 2018. #AHA18 #AHA2018
Feature | Cardiac Diagnostics | November 13, 2018
November 13, 2018 — New cholesterol guidelines from the American Heart Association (AHA) and the American College of
AMI READMITS Score Predicts Heart Attack Patients at High Readmission Risk
News | Cardiac Diagnostics | October 09, 2018
Tracking just seven factors of heart attack patients when they are first admitted to the hospital can help flag those...
Siemens Healthineers Showcases New In Vivo and In Vitro Cardiovascular Solutions at TCT 2018
News | Cardiac Diagnostics | September 21, 2018
At the 2018 Transcatheter Cardiovascular Therapeutics (TCT) conference, Sept. 21-25 in San Diego, Siemens Healthineers...
Weight Loss Drug Does Not Increase Cardiovascular Events
News | Cardiac Diagnostics | August 31, 2018
A weight loss drug does not increase cardiovascular events, according to late breaking results from the CAMELLIA-TIMI...
Acarix Presents CADScor System at ESC 2018
News | Cardiac Diagnostics | August 27, 2018
Acarix AB’s ultra-sensitive acoustic CADScor System for coronary artery disease risk assessment will be on display at...
NIH Ending Funding for Moderate Alcohol and Cardiovascular Health Trial
News | Cardiac Diagnostics | August 24, 2018
The National Institutes of Health announced in June it plans to end funding to the Moderate Alcohol and Cardiovascular...
Study Shows Multiple Benefits of Patient-to-Patient Connectivity in Familial Chylomicronemia Syndrome
News | Cardiac Diagnostics | August 07, 2018
Akcea Therapeutics Inc., an affiliate of Ionis Pharmaceuticals Inc., announced the publication of results from the...
Being Overweight May Change Young Adults' Heart Structure, Function
News | Cardiac Diagnostics | August 03, 2018
Even as a young adult, being overweight may cause higher blood pressure and thicken heart muscle, setting the stage for...
Overlay Init