Health Problem: Cardiac arrhythmias occur when there is abnormal formation or conduction of electrical impulses in the myocardium. General types of arrhythmias include bradycardia, tachycardia, and heart block. Atrial fibrillation (AF) is 1 of the most common arrhythmias, with an estimated prevalence of 2.7 to 6.1 million people with AF in the United States. Arrhythmias may be benign or associated with adverse events such as embolic stroke, damage to vital organs, or sudden death.
Technology Description: The Zio Patch is a single-use, adhesive, external ambulatory electrocardiography (ECG) device that detects cardiac arrhythmias by continuously recording up to 14 days of ECG data. The device has no external wires or electrodes; it records ECG data via a single lead contained in the device housing. At the end of the monitoring period, the device is mailed to the manufacturer for analysis, and a report of ECG data is transmitted to the prescribing physician.
Controversy: It is unknown whether the Zio Patch is as accurate as the reference standard ambulatory ECG monitor, the Holter monitor. The Zio Patch has 1 lead versus the 12 leads of the Holter monitor, which may impact the detection rate of the patch. Also, it is unknown whether use of the Zio Patch has an impact on the clinical management of patients with arrhythmias.
Key Questions:
- Is use of the Zio Patch effective when diagnosing cardiac arrhythmias in symptomatic patients or patients diagnosed with an arrhythmia?
- Is use of the Zio Patch effective when screening for arrhythmias in asymptomatic patients?
- How does the Zio Patch compare with other ambulatory electrocardiography devices?
- Does the Zio Patch provide information that improves treatment decision making and health outcomes?
- Is the Zio Patch safe?
- Have definitive patient selection criteria been identified for the Zio Patch?
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