Christian Thilo, Stephan Achenbach, Claudia Lueg, Laurin Kochinke, Jan Kaufmann, Norman Pfeiffer, Nadine R Lang-Richter, Tobias S Zech, Alice Steiner, Sarah Fiedelak, David Hartmann, Armin Stroebel, Markus Richter, Heribert Schunkert, Lars Anneken
The TS-ECG demonstrated high diagnostic agreement with standard 12-lead ECG for AF detection under controlled clinical conditions. These findings support further evaluation of the system in longitudinal and home-based studies to assess real-world feasibility and clinical utility.
BACKGROUND: Early detection of atrial fibrillation (AF) may reduce the risk of complications such as stroke. This study evaluated the diagnostic performance of a toilet seat-integrated electrocardiogram (TS-ECG) for AF detection under controlled clinical conditions.
METHODS: This prospective multicentre feasibility study included 83 participants (mean age 64 years, 55% male) recruited at two cardiology centres in Germany. Participants were assigned to sinus rhythm (n = 50), AF (n = 28), or other non-AF arrhythmias (n = 5). Each participant underwent simultaneous recordings using a standard 12-lead ECG and the TS-ECG. Recordings were independently interpreted by four experienced cardiologists blinded to device type. The primary endpoint was diagnostic agreement for AF detection between TS-ECG and the reference ECG.
RESULTS: Compared with the 12-lead ECG, the TS-ECG demonstrated a mean sensitivity of 96% (95% CI: 93-98%) and specificity of 95% (92-97%) across readers. When majority voting was applied, sensitivity increased to 99% (98-100%) and specificity to 97% (96-99%). Overall diagnostic accuracy was high across all readers.
CONCLUSION: The TS-ECG demonstrated high diagnostic agreement with standard 12-lead ECG for AF detection under controlled clinical conditions. These findings support further evaluation of the system in longitudinal and home-based studies to assess real-world feasibility and clinical utility.
TRIAL REGISTRATION: DRKS00035167.