Performance of a new leadless implantable cardiac monitor in detecting and quantifying atrial fibrillation - results of the XPECT trial
Abstract
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 treatment. 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, Minn) who were likely to present with paroxysmal AF were selected. A special Holter device stored 46 hours of subcutaneously recorded ECG, ICM markers, and 2 surface ECG leads. The ICM automatic arrhythmia classification was compared with the core laboratory classification of the surface ECG. Of the 206 analyzable Holter recordings collected, 76 (37%) contained at least 1 episode of core laboratory classified AF. The sensitivity, specificity, positive predictive value, and negative predictive value 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 treat AF patients independently of symptoms. Long-term studies are needed to evaluate the clinical benefits of the technology.
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Newer implantable loop recorders have dedicated algorithms resulting in increased interest in their use for AF detection, especially after cryptogenic stroke.
“Newer devices have dedicated algorithms resulting in increased interest in their use for AF detection, especially after cryptogenic stroke.”
From 2021 ISHNE/HRS/EHRA/APHRS Expert Collaborative Statement on mHealth in Arrhythmia Management: Digital Medical Tools for Heart Rhythm Professionals: From the International Society for Holter and Noninvasive Electrocardiology/Heart Rhythm Society/European Heart Rhythm Association/Asia-Pacific Heart Rhythm Society (2021) · cites this paper as Hindricks 2010
The stroke risk in AHRE patients seems lower than the stroke risk in patients with diagnosed AF.
“The stroke risk in AHRE patients seems lower than the stroke risk in patients with diagnosed AF, and not all AHRE represent AF. 142”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [142]
Not all AHRE represent AF.
“The stroke risk in AHRE patients seems lower than the stroke risk in patients with diagnosed AF, and not all AHRE represent AF. 142”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [142]
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- Authors
- Hindricks, G., Pokushalov, E., Urban, L., Taborsky, M., Kuck, K.-H., Lebedev, D., Rieger, G., & Pürerfellner, H.
- Affiliations
- National Institute of Cardiovascular Diseases (SK)
- From the University of Leipzig-Heart Center (G.H.), Leipzig, Germany; State Research Institute of Circulation Pathology (E.P.), Novosibirsk, Russia; The National Institute of Cardiovascular Diseases (L.U.), Bratislava, Slovakia; the Department of Cardiology (M.T.), Na Homolce Hospital, Prague, Czech Republic; the Department of Cardiology (K.-H.K.), Asklepios Klinik St Georg, Hamburg, Germany; Almazov Federal Center of the Heart, Blood, and Endocrinology (D.L.), St Petersburg, Russia; Medtronic (G.R....
- Venue
- Circulation Arrhythmia and Electrophysiology
- Published
- 2010-04
- Volume
- 3
- Issue
- 2
- Pages
- 141-147
- ISSN
- 1941-3084 (ISSN-L)
- 1941-3149
- OpenAlex
- W2144784619
- Cited by
- 422
- References
- 26
- Citations by year
- 2026: 3 · 2025: 10 · 2024: 15 · 2023: 9 · 2022: 11 · 2021: 30 · 2020: 24 · 2019: 20 · 2018: 38 · 2017: 40 · 2016: 43 · 2015: 42 · 2014: 32 · 2013: 30 · 2012: 29
- FWCI
- 21.73
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Circulation Arrhythmia and Electrophysiology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Atrial Fibrillation Management and Outcomes
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac pacing and defibrillation studies
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › ECG Monitoring and Analysis
- Keywords
- atrial fibrillation, implantable cardiac monitors, automatic arrhythmia detection, arrhythmia classification, Holter monitoring, diagnostic accuracy
- MeSH terms
- Adult, Aged, Aged, 80 and over, Algorithms, Atrial Fibrillation, Electrocardiography, Electrodes, Implanted, Female, Humans, Male, Middle Aged, Monitoring, Physiologic, Predictive Value of Tests, Prospective Studies, Reference Values, Sensitivity and Specificity, Reproducibility of Results, Electrocardiography, Ambulatory
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