Use of an ECG patch to remotely screen older patients at moderate-to-high stroke risk demonstrated modest benefits in long-term atrial fibrillation (AFib) diagnosis and anticoagulation exposure, based on findings from the AMALFI Trial presented at ESC Congress 2025 and simultaneously published in JAMA.

Rohan Wijesurendra, MD, et al., randomized 5,040 individuals identified from 27 primary care practices in the UK using an automated electronic health record search to either usual care or a 14-day continuous ECG monitoring patch that was sent to them by mail. The mean age of patients at baseline was 78 years, 47% were female and 19% had a prior stroke or transient ischemic attack. The primary outcome was the proportion of participants with the presence of AFib in primary care records within 2.5 years following randomization.

Based on the findings, AFib was diagnosed by 2.5 years after randomization in 172 individuals (6.8%) who received the patch compared with 136 (5.4%) in the control group. According to study investigators, patch-detected AFib burden was bimodally distributed, with 33% of cases having 100% burden (the entire monitoring period was spent in AFib), while more than half (55%) had low AFib burden of less than 10%.

AMALFI also included exploratory outcomes looking at exposure to oral anticoagulation and stroke. At 2.5 years, mean exposure to oral anticoagulation was 1.63 months in the intervention group compared with 1.14 months in the control group. Stroke occurred in 2.7% of participants who received the patch and 2.5% in those receiving usual care.

"Our trial shows that remote AFib screening with an ECG patch monitor in older patients at moderate-to-high stroke risk leads to a modest increase in AFib diagnosis and anticoagulation exposure," said Wijesurendra. "However, AFib diagnosis unrelated to the patch occurred more commonly than anticipated and over half of the patch-detected AFib burden was low burden. This suggests that AFib screening in this setting may have limited impact on stroke events; longer-term and cost-effectiveness analyses of AMALFI are planned and will provide more insight in due course."