The first-of-its-kind app-based DEFINE AFib study used AFib burden data to identify patients at high risk for AFib-related healthcare utilization. It found that Linq ICMs showed four times greater episode sensitivity than the Apple Watch. Investigators presented results at the AFib Symposium.
Primary results showed that Linq ICMs, paired with a novel algorithm, could detect AFib episodes and properly risk stratify patients as high risk prior to an AFib-related healthcare utilization 80% of the time. Using AI-based algorithms, the Reveal Linq and Linq II ICMs quantified AFib burden to inform treatment decisions and help anticipate future healthcare needs.
DEFINE AFib enrolled 973 patients using an app-based enrollment feature. It characterized the impact of AFib burden on patient outcomes and quality of life. Using the data, researchers built an algorithm capable of predicting patients’ risk of needing AFib-related healthcare in the next 30-day period. It also predicted clinically meaningful reductions in patient-reported quality of life.
Results showed that 22% of patients who crossed into the high-risk threshold for the first time experienced an AFib-related healthcare utilization (AFHCU). This occurred at a mean time of 164±145 days. That compared to 9% of patients in the low-risk group. Data supports the conclusion that the AI-based analytics from the ICMs provide valuable information. That rings particularly true for those at a higher risk of an AFib-related hospitalization, clinic visit, or therapeutic intervention.
A sub-analysis also highlighted the differences in performance between Linq devices and the Apple Watch for AFib detection. Medtronic says a 40% of AFib episodes (191) occurred without the user wearing the Apple Watch. Additionally, when worn, the watch only detected 26% of AFib episodes detected by the Linq ICM.
“Wearables allow patients to capture more real-time heart health data than ever before, but medical grade technology, like the LINQ family of ICMs, is necessary to provide clinicians with an accurate and reliable way to detect and manage cardiac conditions like AFib,” said Dr. Alan Cheng, chief medical officer of the Cardiac Rhythm Management business, at Medtronic. “These findings also indicate that, while consumer-grade devices such as smartwatches and monitors can provide some insights into overall heart health, they are limited in their ability to screen for and help manage chronic conditions like AFib. Medical grade devices with continuous monitoring capabilities like ICMs are more appropriate.”
