A novel three-vector implantable cardiac monitor demonstrated an atrial fibrillation detection sensitivity of 95.4% and a positive predictive value of 76.3% compared to 48-hour Holter monitoring.
Observational (n=66)
Does a novel three-vector implantable cardiac monitor accurately detect atrial fibrillation episodes compared to 48-hour Holter monitoring in patients at risk for AF?
A novel three-vector implantable cardiac monitor demonstrates high sensitivity (95.4%) and moderate positive predictive value (76.3%) for detecting atrial fibrillation episodes compared to 48-hour Holter monitoring.
AIMS: 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. METHODS AND 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. CONCLUSION: 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.
Ciconte et al. (2016) conducted an observational in Atrial fibrillation (n=66). Three-vector implantable cardiac monitor (BioMonitor) vs. 48-hour ECG Holter monitoring was evaluated on Atrial fibrillation detection sensitivity and positive predictive value for episode analysis. A novel three-vector implantable cardiac monitor demonstrated an atrial fibrillation detection sensitivity of 95.4% and a positive predictive value of 76.3% compared to 48-hour Holter monitoring.
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