Next-generation Ambulatory ECG Monitor Delivers High-quality Clinical Data
Presenter: Jay H. Alexander, MD, of North Shore University Health System Faculty Practice, Evanston, IL
A lighter, more compliant next-generation ECG monitor may improve both patient and provider experience, with both standard 14-day and extended 30-day wear.
The optimal design of ambulatory ECG monitoring (AEM) devices may improve patient experience and compliance, provide more complete data, and enhance clinical decision-making. AEM monitoring over 14 days has been shown to have superior diagnostic yield than traditional 48-hour Holter monitoring for infrequent arrhythmias.
The first-generation Zio patch (Zio XT) and Zeus analysis system received FDA clearance in 2009. To date, more than 6 million Zio devices have been prescribed. A new, uninterrupted patch-based AEM with next-generation breathable adhesive, storage, and battery life received FDA clearance for 14-day wear in May 2021.
Presenter Jay H. Alexander, MD, of North Shore University Health System Faculty Practice, provided the details of the first report of wear and clinical experience of the new monitor. Researchers analyzed commercial data from 673 monitors prescribed by 75 U.S. physicians. Wear metrics, analyzable data, and clinical findings were determined and compared to 262,284 patients who wore the Zio XT.
The median age of the patients who wore these two monitors was 66 years; 46% were female. The primary indications for wearing a monitor were palpitations (33%), paroxysmal atrial fibrillation (8%), and syncope and collapse (9%).
In addition, the researchers analyzed data from 30 patients enrolled in an IRB-approved, extended-wear validation study of safety and feasibility of 30-day wear. The median age of patients was 35 years; one- quarter were female and three-quarters were male.
Virtually all patients wore their monitors for the full 14-day or 30-day prescribed periods. ECGs were analyzable for 99% of all patients.
“Zio monitors demonstrated high compliance and high-quality ECG,” said Alexander. “The Zio monitor showed high wear metrics and analyzable ECG as compared to national Zio XT prescriptions.”
The arrhythmia yield was 77.1% for Zio XT and 80.9% for Zio monitor (p = 0.0168). Arrhythmia yield was calculated by atrial fibrillation of 30 or more seconds, supraventricular tachycardia of 90 or more beats per minute (bpm), ventricular tachycardia of 100 or more bpm, including polymorphic ventricular tachycardia/Torsades de Pointes/ventricular fibrillation, pause of 3 or more seconds, and/or atrioventricular block.
“The 30-day clinical data demonstrated high compliance and high analyzable ECG, with no subjects experiencing clinically significant skin irritation,” said Alexander. He noted that extended wear monitoring yielded additional clinical findings beyond 14 days.
In conclusion, Alexander said, “The post-clearance evaluations of this next-generation ECG monitor showed consistent and even improved performance, with potential to greatly improve monitoring and decision-making in patient care.”
References
Rosenberg MA, Samuel M, Thosani A, et al. Use of a noninvasive continuous monitoring device in the management of atrial fibrillation: a pilot study. Pacing Clin Electrophysiol 2013; 36(3):328-333. doi: 10.1111/pace.12053. Epub 2012 Dec 13. PMID: 23240827; PMCID: PMC3618372.
Alexander JH, Hsu M, Ellis J, et al. Initial real-world and clinical experience of the next-generation ambulatory ECG Zio monitor: implications for standard and extended wear monitoring. Presented at American College of Cardiology Annual Scientific Session & Expo Together With World Congress of Cardiology, March 4, 2023, New Orleans, LA. Presentation Number: 1021-07.
Disclosures
Jay H. Alexander: Consultant Fees/Honoraria - iRhythm Technologies; Officer, Director, Trustee, or other Fiduciary Role - iRhythm Technologies