Continuing evaluation of atrial fibrillation detection after cryptogenic stroke: 2-year findings from a multicentre study with Confirm Rx ICM.

Abstract

Background: The detection of atrial fibrillation (AF) after a cryptogenic stroke (CS) carries important therapeutic implications. In this study, we aimed to accurately assess the incidence of AF among CS subjects by using an insertable cardiac monitor (ICM).

Methods: A prospective, single-arm, multicentre registry was conducted to identify AF in 155 CS subjects using the Confirm Rx ICM (Abbott, California, USA) across 20 global sites. Inclusion criteria comprised participants aged 40 years or older who had experienced CS within a 90-day window. At each follow-up visit, expert electrophysiologists reviewed and adjudicated ICM detected AF episodes. The primary endpoint was the cumulative incidence of true device-detected AF (lasting more than 30 s) at 6 months, evaluated with Kaplan-Meier methods.

Results: AF incidence was 21.3% (95% CI 15.3% to 29.1%) at 6 months, increasing to 48.8% (95% CI 34.7% to 64.9%) at 24 months. Subjects with AF detection experienced an average of 50.9 true AF episodes per subject per year. The median time from implantation to AF detection (>30 s) was 72 days (IQR 7-261). Among subjects with 30 s AF detection, anticoagulation therapy was initiated in 65.2% (30/46) of subjects. Oral anticoagulation medication was prescribed in 8.3% (9/109) of subjects without AF. Recurrent ischaemic stroke or transient ischaemic attack occurred in 5 subjects (3.2%, 5/155).

Conclusion: These results show that ICM-driven long-term continuous AF monitoring is associated with high diagnostic yield in CS subjects.

Trial registration number: NCT03505801.