Elsevier

Heart Rhythm

Volume 13, Issue 7, July 2016, Pages 1425-1430
Heart Rhythm

Performance of a new atrial fibrillation detection algorithm in a miniaturized insertable cardiac monitor: Results from the Reveal LINQ Usability Study

https://doi.org/10.1016/j.hrthm.2016.03.005Get rights and content
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Background

For clinicians, confidence in atrial fibrillation (AF) episode classification is an important consideration when electing to use insertable cardiac monitors (ICMs).

Objective

The purpose of this study was to report on the improved AF detection algorithm in the Reveal LINQ ICM.

Methods

The Reveal LINQ Usability Study is a nonrandomized, prospective, multicenter trial. The ICM has been miniaturized, uses wireless telemetry for remote patient monitoring, and its AF algorithm includes a new p-wave filter. At 1 month post-device insertion, Holter monitor data were collected and annotated for true AF episodes ≥2 minutes, and performance metrics were evaluated by comparing Holter annotations with ICM detections.

Results

The study enrolled 151 patients (age 56.6 ± 12.1, male 67%). Reasons for monitoring included AF ablation or AF management in 81.5% (n = 123), syncope in 12.6% (n = 19), and other indications in 5.9% (n = 9) of patients. Of the 138 patients with an analyzable Holter recording, a total of 112 true AF episodes were identified in 38 patients (27.5%). The overall accuracy of the ICM to detect durations of AF or non-AF episodes was 99.4%, and the AF burden measured by the ICM was highly correlated with the Holter (Pearson coefficient 0.995).

Conclusion

The new AF detection algorithm in the Reveal LINQ ICM accurately detects the presence or absence of AF. Additionally, it showed high sensitivity in detecting AF duration in patients with a history of intermittent and symptomatic AF.

Keywords

Atrial fibrillation
Insertable cardiac monitor
Diagnosis
Long-term monitoring

Cited by (0)

The study was funded by Medtronic. Dr. Sanders is supported by a Practitioner Fellowship from the National Health and Medical Research Council of Australia and by the National Heart Foundation of Australia; reports having served on the advisory board of Biosense Webster, Medtronic, and St. Jude Medical; having received lecture fees from Biosense Webster, Medtronic, St. Jude Medical, and Boston Scientific, Merck; and having received research funding from Medtronic, St. Jude Medical, Boston Scientific, Biotronik, and Sorin. Dr. Pürerfellner reports having received consultancy fees from Medtronic and honoraria from St. Jude Medical, Biosense Webster, Sanofi, Daichi-Sankyo, Böhringer-Ingelheim, and Bristol-Myers Squibb. Dr. Dekker reports having received consultancy fees from Medtronic and St. Jude Medical, and research support from Medtronic, St. Jude Medical, and Philips. Dr. Pokushalov reports having received honoraria from Medtronic, Biosense Webster, and Boston Scientific. Drs. Sarkar, Di Bacco, and Maus are employees of Medtronic.