title: Atrial fibrillation detection using a novel three-vector cardiac implantable monitor: the atrial fibrillation detect study.
abstract: OBJECTIVE
  Continuous rhythm monitoring is valuable for adequate atrial fibrillation (AF) management in the clinical setting. Subcutaneous leadless implantable cardiac monitors (ICMs) yield an improved AF detection, overcoming the intrinsic limitations of the currently available external recording systems, thus resulting in a more accurate patient treatment. The study purpose was to assess the detection performance of a novel three-vector ICM device equipped with a dedicated AF algorithm.
  
  
  RESULTS
  Sixty-six patients (86.4% males; mean age 60.4 ± 9.4 years) at risk to present AF episodes, having undergone the novel ICM implant (BioMonitor, Biotronik SE&Co. KG, Berlin, Germany), were enrolled. External 48-h ECG Holter was performed 4 weeks after the device implantation. The automatic ICM AF classification was compared with the manual Holter arrhythmia recordings. Of the overall study population, 63/66 (95.5%) had analysable Holter data, 39/63 (62%) showed at least one true AF episode. All these patients had at least one AF episode stored in the ICM. On Holter monitoring, 24/63 (38%) patients did not show AF episodes, in 16 of them (16/24, 67%), the ICM confirmed the absence of AF. The AF detection sensitivity and positive predictive value for episodes' analysis were 95.4 and 76.3%, respectively.
  
  
  CONCLUSIONS
  Continuous monitoring using this novel device, equipped with a dedicated detection algorithm, yields an accurate and reliable detection of AF episodes. The ICM is a promising tool for tailoring individual AF patient management. Further long-term prospective studies are necessary to confirm these encouraging results.
authors.affiliation: Department of Arrhythmology, IRCCS Policlinico San Donato, University of Milan, Piazza E. Malan 1, 20097 San Donato Milanese (MI), Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Ciconte
authors.affiliation: Department of Arrhythmology, IRCCS Policlinico San Donato, University of Milan, Piazza E. Malan 1, 20097 San Donato Milanese (MI), Italy.
authors.forename: Massimo
authors.initials: M
authors.lastname: Saviano
authors.affiliation: Department of Arrhythmology, IRCCS Policlinico San Donato, University of Milan, Piazza E. Malan 1, 20097 San Donato Milanese (MI), Italy.
authors.forename: Luigi
authors.initials: L
authors.lastname: Giannelli
authors.affiliation: Department of Arrhythmology, IRCCS Policlinico San Donato, University of Milan, Piazza E. Malan 1, 20097 San Donato Milanese (MI), Italy.
authors.forename: Zarko
authors.initials: Z
authors.lastname: Calovic
authors.affiliation: Department of Arrhythmology, IRCCS Policlinico San Donato, University of Milan, Piazza E. Malan 1, 20097 San Donato Milanese (MI), Italy.
authors.forename: Mario
authors.initials: M
authors.lastname: Baldi
authors.affiliation: Department of Arrhythmology, IRCCS Policlinico San Donato, University of Milan, Piazza E. Malan 1, 20097 San Donato Milanese (MI), Italy.
authors.forename: Cristiano
authors.initials: C
authors.lastname: Ciaccio
authors.affiliation: Department of Arrhythmology, IRCCS Policlinico San Donato, University of Milan, Piazza E. Malan 1, 20097 San Donato Milanese (MI), Italy.
authors.forename: Amarild
authors.initials: A
authors.lastname: Cuko
authors.affiliation: Department of Arrhythmology, IRCCS Policlinico San Donato, University of Milan, Piazza E. Malan 1, 20097 San Donato Milanese (MI), Italy.
authors.forename: Raffaele
authors.initials: R
authors.lastname: Vitale
authors.affiliation: Biotronik Italia, Clinical Research, Vimodrone (MI), Italy.
authors.forename: Daniele
authors.initials: D
authors.lastname: Giacopelli
authors.affiliation: Department of Arrhythmology, IRCCS Policlinico San Donato, University of Milan, Piazza E. Malan 1, 20097 San Donato Milanese (MI), Italy.
authors.forename: Manuel
authors.initials: M
authors.lastname: Conti
authors.affiliation: Department of Arrhythmology, IRCCS Policlinico San Donato, University of Milan, Piazza E. Malan 1, 20097 San Donato Milanese (MI), Italy.
authors.forename: Felicia
authors.initials: F
authors.lastname: Lipartiti
authors.affiliation: Department of Arrhythmology, IRCCS Policlinico San Donato, University of Milan, Piazza E. Malan 1, 20097 San Donato Milanese (MI), Italy.
authors.forename: Federica
authors.initials: F
authors.lastname: Giordano
authors.affiliation: Department of Arrhythmology, IRCCS Policlinico San Donato, University of Milan, Piazza E. Malan 1, 20097 San Donato Milanese (MI), Italy.
authors.forename: Fabio
authors.initials: F
authors.lastname: Maresca
authors.affiliation: Department of Arrhythmology, IRCCS Policlinico San Donato, University of Milan, Piazza E. Malan 1, 20097 San Donato Milanese (MI), Italy.
authors.forename: Mario
authors.initials: M
authors.lastname: Moscatiello
authors.affiliation: Department of Arrhythmology, IRCCS Policlinico San Donato, University of Milan, Piazza E. Malan 1, 20097 San Donato Milanese (MI), Italy.
authors.forename: Gabriele
authors.initials: G
authors.lastname: Vicedomini
authors.affiliation: Department of Arrhythmology, IRCCS Policlinico San Donato, University of Milan, Piazza E. Malan 1, 20097 San Donato Milanese (MI), Italy.
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Santinelli
authors.affiliation: Department of Arrhythmology, IRCCS Policlinico San Donato, University of Milan, Piazza E. Malan 1, 20097 San Donato Milanese (MI), Italy.
authors.forename: Carlo
authors.initials: C
authors.lastname: Pappone
mesh_terms: D000200:Action Potentials; D000368:Aged; D000465:Algorithms; D001281:Atrial Fibrillation / Q000175:diagnosis* / Q000503:physiopathology; D004562:Electrocardiography / Q000295:instrumentation*; D015716:Electrocardiography, Ambulatory; D004867:Equipment Design; D005260:Female; D006329:Heart Conduction System / Q000503:physiopathology*; D006339:Heart Rate; D006801:Humans; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D058998:Remote Sensing Technology / Q000295:instrumentation*; D015203:Reproducibility of Results; D012815:Signal Processing, Computer-Assisted; D013686:Telemetry / Q000295:instrumentation*; D013997:Time Factors
keywords: Atrial fibrillation; BioMonitor; Continuous monitoring; Implantable cardiac monitor; Implantable loop recorder