Hot Line 1: AMALFI
30 Aug 2025
Hot Line ESC Congress 2025 Remote screening for asymptomatic atrial fibrillation – does it work?
Introducing the AMALFI trial, Professor Louise Bowman (Oxford Population Health - Oxford, UK), said: “The advent of new monitoring technology has enabled longer-duration screening for atrial fibrillation (AF). Our trial was designed to assess the long-term efficacy of remote screening for asymptomatic AF in older individuals at increased risk of stroke using a 14-day continuous ECG monitoring patch.”
In the investigator-initiated, unblinded AMALFI trial, eligible individuals were identified from 27 UK primary care practices via automated electronic health record searches. Participants were aged ≥65 years with a CHA2DS2VASc stroke risk score ≥3 for men or ≥4 for women, without a previous diagnosis of AF or atrial flutter. Participants were randomised either to receive and return by postal mail an ECG patch monitor or to usual care. The primary outcome was the proportion of participants with the presence of AF in primary care records within 2.5 years after randomisation, which was analysed using an intention-to-treat approach.
A total of 5,040 individuals were randomised. At baseline, participants had a mean age of 78 years, 47% were female and 19% had a prior stroke or transient ischaemic attack.
There was a modest increase in AF diagnosis at 2.5 years with the ECG patch.
A post-randomisation primary care record of AF was present in 6.8% of individuals in the intervention arm and 5.4% in the control arm (ratio of proportions 1.26; 95% CI 1.02 to 1.57; p=0.03). Patch-detected AF burden was bimodally distributed, with 33% of cases having 100% burden, while 55% had an AF burden <10%.
At 2.5 years, mean exposure to oral anticoagulation was 1.63 months in the intervention arm and 1.14 months in the control arm (difference 0.50 months; 95% CI 0.24 to 0.75; p<0.0001). Stroke occurred in 2.7% of participants in the intervention arm and 2.5% in the control arm (event rate ratio 1.08; 95% CI 0.76 to 1.53).
“Our trial shows that remote AF screening with an ECG patch monitor in older patients at moderate-to-high stroke risk leads to a modest increase in AF diagnosis and anticoagulation exposure,” concluded AMALFI Investigator, Doctor Rohan Wijesurendra (Oxford Population Health - Oxford, UK). “However, AF diagnosis unrelated to the patch occurred more commonly than anticipated and over half of the patch-detected AF burden was low burden (below 10%). This suggests that AF screening in this setting may have limited impact; longer-term and cost-effectiveness analyses of AMALFI are planned and will provide more insight in due course.”
