Continuing evaluation of atrial fibrillation detection after cryptogenic stroke: one-year findings from a multi-center study with confirm Rx ICM

Abstract

Abstract Background The detection of atrial fibrillation (AF) after a cryptogenic stroke (CS) carries crucial therapeutic implications. While clinical trials have meticulously explored the incidence of AF in CS patients, real-world data on this topic remain relatively sparse. In this study, we aimed to assess the incidence of AF among patients with cryptogenic stroke, who underwent the implantation of an insertable cardiac monitor (ICM). The abstract reports the interim results from the CS sub-study of the Smart Registry. Methods A prospective, single-arm, multi-center registry was conducted to identify AF in patients with cryptogenic stroke using the Confirm R ICM. Inclusion criteria comprised participants aged 40 years or older who had experienced cryptogenic strokes within a 90-day window. Prior to enrollment, comprehensive diagnostic assessments were performed to meticulously rule out all potential sources of embolism, in accordance with the minimal standards of the American and European Guidelines. 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 seconds) at 6 months. Kaplan-Meier curves were employed to assess the cumulative incidence of true device-detected AF through 12 months. Results In our study, 117 patients were enrolled across 19 global sites from September 2021 to August 31, 2023. Kaplan-Meier analysis revealed a 21.3% probability (confidence interval (CI): 14.5%, 30.7%) of true AF episodes lasting more than 30 seconds at 6 months, increasing to 31.0% (CI: 22.0%, 42.5%) at 12 months. Similar results were observed in episodes lasting over 120 seconds at both 6 months (20.7%) and 12 months (30.5%). In average, 14.4 true AF episodes per patient were detected per year. The median time from implantation to AF detection (> 30 seconds) was 31.5 days (interquartile range, 7 to 191). Conclusion Our ongoing study illustrates the effectiveness of the Confirm Rx ICM in detecting atrial fibrillation after cryptogenic stroke. These results confirm the diagnostics value of long-term continuous AF monitoring in cryptogenic stroke patients.