World’s Smallest Insertable Cardiac Monitor Shows 10-Fold Increase in AF Detection

Every year, stroke affects over 795,000 individuals. A vast majority, more than 87%, of these strokes are ischemic, which are caused by blockages in the blood vessels supplying the brain. Those suffering from atrial fibrillation (AF) are five times more likely to experience ischemic stroke. Now, the findings of a clinical study have shown that stroke patients with both large and small vessel disease witnessed a ten-fold increase in AF detection over three years with the use of an insertable cardiac monitor (ICM), compared to those who received standard care without constant, long-term monitoring.

Medtronic plc’s (Dublin, Ireland) LINQ family of ICMs provides continuous, long-term monitoring for patients at risk of irregular heart rhythms. These patients may experience symptoms such as dizziness, heart palpitations, syncope (fainting), and chest pain, which necessitate ongoing monitoring or management. Late-breaking clinical data from the STROKE AF clinical study demonstrates that the LINQ ICM, the smallest ICM globally, detects 10 times more AF in ischemic stroke patients at three years compared to standard care. The STROKE AF study is a prospective, randomized study involving 496 large and small vessel stroke patients from 33 centers in the U.S. These findings reinforce the continuous of continuous cardiac monitoring in ischemic stroke patients.

These recent results build on the STROKE AF study 12-month primary endpoint results published in June 2021. Over the first year, AF was detected in 12.5% of patients in the ICM group, compared to 1.8% of patients who received standard care (which involves external cardiac monitoring such as 12-lead ECGs, Holter monitoring, telemetry, or event recorders). After three years, the rate of AF detection rose to 21.7% in the ICM group versus 2.4% in the control group, resulting in a statistically significant hazard ratio of 10 (95% CI 4.0-25.2, p<0.001). The study also showed that 67% of patients (31 out of 46) in the ICM group had clinically significant AF episodes lasting over an hour, while 88% of AF episodes were asymptomatic.

In addition, Medtronic has obtained market clearance from the U.S. Food and Drug Administration to incorporate the AccuRhythm AI algorithms into the Reveal LINQ ICM. Medtronic launched the AccuRhythm AI algorithms in 2022 to improve the accuracy of information received by physicians, thereby improving patient care. These AI algorithms were developed by Medtronic using its proprietary, diverse, and unbiased database of over a million electrocardiogram heart rhythm episodes. The company expects the AccuRhythm AI algorithms to reduce approximately 89.5% of AF false alerts and 80.2% of pause false alerts with Reveal LINQ, while maintaining true alerts at rates of 98.2% and 99.9%, respectively.

"Adding AccuRhythm AI to the thousands of Reveal LINQ ICMs currently implanted in patients globally is important as it will help reduce the data burden on many hospitals and clinics that still regularly use this device for monitoring their patients," said Alan Cheng, M.D., vice president and chief medical officer for Cardiac Rhythm Management Operating Unit, which is part of the Cardiovascular Portfolio at Medtronic.

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