When each device is compared incrementally , BioMonitor 2-AF dominates Reveal LINQ and Confirm RX .
BACKGROUND Cryptogenic stroke is a stroke for which no cause is identified after st and ard diagnostic tests .
Long-term implantable cardiac monitors may be better at diagnosing atrial fibrillation and provide an opportunity to reduce the risk of stroke recurrence with anticoagulants .
OBJECTIVES The objectives were to assess the diagnostic test accuracy , clinical effectiveness and cost-effectiveness of three implantable monitors [ BioMonitor 2-AF ™ ( Biotronik SE & Co. KG , Berlin , Germany ) , Confirm Rx ™ ( Abbott Laboratories , Lake Bluff , IL , USA ) and Reveal LINQ ™ ( Medtronic plc , Minneapolis , MN , USA ) ] in patients who have had a cryptogenic stroke and for whom no atrial fibrillation is detected after 24 hours of external electrocardiographic monitoring .
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 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 . Clinical Trial Registration — clinical trials.gov Identifier NCT00680927
When each device is compared incrementally , BioMonitor 2-AF dominates Reveal LINQ and Confirm RX .
BACKGROUND Cryptogenic stroke is a stroke for which no cause is identified after st and ard diagnostic tests .
Long-term implantable cardiac monitors may be better at diagnosing atrial fibrillation and provide an opportunity to reduce the risk of stroke recurrence with anticoagulants .
OBJECTIVES The objectives were to assess the diagnostic test accuracy , clinical effectiveness and cost-effectiveness of three implantable monitors [ BioMonitor 2-AF ™ ( Biotronik SE & Co. KG , Berlin , Germany ) , Confirm Rx ™ ( Abbott Laboratories , Lake Bluff , IL , USA ) and Reveal LINQ ™ ( Medtronic plc , Minneapolis , MN , USA ) ] in patients who have had a cryptogenic stroke and for whom no atrial fibrillation is detected after 24 hours of external electrocardiographic monitoring .