Real world study of Reveal LINQ Insertable Cardiac Monitor to detect atrial fibrillation.- Medtronic

Medtronic plc announced one-year results from a real-world study of patients who had a cryptogenic stroke, or stroke of unknown cause. The study found that the Reveal LINQ Insertable Cardiac Monitor (ICM) detected atrial fibrillation (AF) at a greater rate than previously reported in a randomized controlled clinical trial (the CRYSTAL AF Study, published in The New England Journal of Medicine in 2014). The results from the observational real-world study were presented at the 68th American Academy of Neurology Annual Meeting in Vancouver, Canada.

The study evaluated 1,247 patients across the U.S. to understand the incidence and duration of AF episodes in a large, real-world population of cryptogenic stroke patients with an ICM after one year of follow up and to compare the AF detection rates among these patients to those of the CRYSTAL AF Study. At 12 months, 1,737 AF episodes were detected in 192 patients, resulting in an AF detection rate of 16.3 percent. This represents a 32 percent relative increase compared to the rate observed in the CRYSTAL AF Study at the same time. The current recommended guidelines for AF detection are 30-days of monitoring within six months of having a cryptogenic stroke. However, because AF may occur infrequently, it may not be detected by conventional monitoring techniques such as in-hospital monitoring, electrocardiography or traditional ambulatory cardiac monitors such as a Holter. The real-world study found that 72 percent of patients diagnosed with AF would have been undiagnosed if their cardiac monitoring had been limited to 30 days.

Comment:The Reveal LINQ ICM is indicated for patients who experience symptoms such as dizziness, palpitation, syncope (fainting) and chest pain that may suggest a cardiac arrhythmia, and for patients at increased risk for cardiac arrhythmia.

Comment:Reveal LINQ Insertable Cardiac Monitor (ICM) System is the smallest implantable cardiac monitoring device available for patients and is available in the US and EU.