Performance of a new Leadless Implantable Cardiac Monitor in Detecting and Quantifying Atrial Fibrillation - Results of the XPECT Trial
Background—Current methods for detecting Atrial Fibrillation (AF) have limited diagnostic yield. Continuous monitoring with automatic arrhythmia detection and classification may improve detection of symptomatic and asymptomatic AF and subsequent patient management. The study purpose was to quantify the performance of the first implantable leadless cardiac monitor (ICM) with dedicated AF detection capabilities.
Methods and Results—Patients (n=247) with an implanted ICM (Reveal®; XT, Medtronic Inc., Minneapolis, MN) who were likely to present with paroxysmal AF were selected. A special Holter device stored 46 hours of subcutaneously recorded ECG, ICM markers, and two surface ECG leads. The ICM's automatic arrhythmia classification was compared to the core-lab's classification of the surface ECG. Of the 206 analyzable Holter recordings collected, 76 (37%) contained at least one episode of core-lab classified AF. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for identifying patients with any AF were 96.1%, 85.4%, 79.3%, and 97.4% respectively. The AF burden measured with the ICM was very well correlated with the reference value derived from the Holter (Pearson coefficient=0.97). The overall accuracy of the ICM for detecting AF was 98.5%.
Conclusions—In this ICM validation study the dedicated AF detection algorithm reliably detected the presence or absence of AF and the AF burden was accurately quantified. The ICM is a promising new diagnostic and monitoring tool for the clinician to manage AF patients independently of symptoms. Long-term studies are needed to evaluate the clinical benefits of the technology.
- Received May 8, 2009.
- Accepted January 4, 2010.
- Copyright © 2010, American Heart Association, Inc. All rights reserved. Unauthorized use prohibited