Performance of the imPulse device for the detection of atrial fibrillation in hospital settings

Sinéad T J McDonagh; Shelley Rhodes; Fiona C Warren; Sam Keenan; Claire Pentecost; Philip Keeling; Martin James; Rod S Taylor; Christopher E Clark

doi:10.1016/j.cvdhj.2022.05.002

Performance of the imPulse device for the detection of atrial fibrillation in hospital settings

Cardiovasc Digit Health J. 2022 May 26;3(4):171-178. doi: 10.1016/j.cvdhj.2022.05.002. eCollection 2022 Aug.

Authors

Affiliations

¹ Primary Care Research Group, Exeter, United Kingdom.
² Exeter Clinical Trials Unit, College of Medicine and Health, University of Exeter Medical School, Exeter, United Kingdom.
³ Royal Devon and Exeter National Health Service Foundation Trust, Exeter, United Kingdom.
⁴ Torbay and South Devon NHS Foundation Trust, Torquay, United Kingdom.
⁵ MRC/CSO Social and Public Health Sciences Unit & Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, Scotland.

Abstract

Background: Atrial fibrillation (AF) increases thromboembolism and stroke risk; this can be reduced by oral anticoagulation, but only if AF is detected. A portable, point-of-care device, capable of accurately detecting and identifying AF, could reduce workload and diagnostic delay by minimizing need for follow-up 12-lead electrocardiogram (ECGs).

Objective: To assess the diagnostic performance of the Plessey imPulse lead I ECG device compared with a 12-lead ECG in detecting AF.

Methods: Cross-sectional diagnostic accuracy study. Participants underwent simultaneous 12-lead ECG and imPulse device recordings. The imPulse device reports AF to be "probable," "possible," "unlikely," or "uncontrolled AF unlikely." imPulse and ECG reference results were cross-tabulated; sensitivity, specificity, positive/negative predictive values, and positive/negative likelihood ratios with 95% confidence interval (CI) were estimated based on different imPulse device report categorizations and heart rate subgroups.

Results: A total of 217 participants were recruited (mean age 70.2 [standard deviation 12.7]), 56% male, 57% outpatients, 43% inpatients) and 199 were included in analyses. AF was diagnosed on ECG for 41 of 199 (20.6%) participants and reported by imPulse as possible, probable, or uncontrolled AF unlikely present for 49 of 199 (24.6%). Sensitivity and specificity for imPulse detection of possible, probable, or uncontrolled AF unlikely vs unlikely, compared with ECG, were 80.5% (95% CI, 65.1%-91.2%) and 89.9% (84.1%-94.1%), respectively. When probable or uncontrolled AF unlikely were compared vs possible or unlikely AF, sensitivity and specificity were 63.4% (46.9%-77.9%) and 98.1% (94.6%-99.6%), respectively.

Conclusion: The imPulse device has moderate sensitivity and good specificity compared with ECG AF detection in a hospital setting.

Keywords: Arrhythmia; Atrial fibrillation; Diagnostics; Screening; Sensitivity; Specificity.