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 .
Safety Profile of a Miniaturized Insertable Cardiac Monitor: Results from Two Prospective Trials.
BACKGROUND Insertable cardiac monitors ( ICMs ) are used to continuously monitor the patient 's electrocardiogram . In response to patient activation or based on automated device algorithms , arrhythmia episodes are stored and automatically transmitted daily to the clinician . Thus , ICMs can be used to diagnose arrhythmias in at-risk patients and in those with symptoms potentially attributable to arrhythmias . The ICM described in this report has undergone a dramatic change in size and method of insertion . METHODS To evaluate the safety profile of the ICM procedure , we analyzed procedure-related adverse events ( AEs ) from two separate trials : A controlled , nonr and omized multicenter study ( Reveal LINQ(TM ) Usability study ) and a multicenter registry ( Reveal LINQ(TM ) Registry ) evaluating real-world experience . For the Registry we reported all procedure-related AEs upon occurrence , whereas for the Usability study , we reported events occurring during the first month of follow-up . RESULTS The Usability study enrolled 151 patients ( age 56.6 ± 12.1 years ; male 67 % ) at 16 centers ; during follow-up , an infection was observed in 1.3 % patients and a procedure-related serious AE ( SAE ) in 0.7 % patients . The Registry enrolled 122 patients ( age 61.0 ± 17.8 years ; male 47 % ) at seven centers ; during follow-up , an infection was observed in 1.6 % patients and a procedure-related SAE in 1.6 % patients . CONCLUSIONS The cumulative experience from a controlled clinical trial and a " real-world " registry demonstrate that the new ICM can be inserted with very low incidence of AEs
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 .