A study to assess a novel automated electrocardiogram technology in screening for atrial fibrillation. Issue 10 (16th September 2019)

• Record Type: Journal Article
• Authors: Sabar, Muhammad I.; Ara, Farhana; Henderson, Alice; Ahmed, Omar; Potter, Christina; John, Isaac; Mitchell, Andrew R.J.; Yáñez‐Muñoz, Rafael J.; Kaba, Riyaz A.
• Is Part Of: Pacing and clinical electrophysiology. Volume 42:Issue 10(2019)
• Page Start: 1383
• Page End: 1389
• Publication Date: 2019-09-16
• Subjects: atrial fibrillation -- detection -- electrocardiogram -- novel devices -- screening; Cardiac pacing -- Periodicals; Electrophysiology -- Periodicals; 617.4120645
• DOI: 10.1111/pace.13800
• Languages: English
• ISSNs: 0147-8389

Abstract

Abstract: Introduction: Atrial fibrillation is often asymptomatic and un‐diagnosed in the community resulting in an increased risk of heart failure and stroke to those patients. We evaluated the effectiveness, tolerability, and accuracy of a novel six‐channel electrocardiogram digital‐health screening device, the RhythmPad, for the detection of atrial fibrillation. Methods: Seven hundred and fifty‐two participants attending the cardiology department were recruited. Two recordings were taken—a six‐lead electrocardiogram using the RhythmPad device and a standard 12‐lead electrocardiogram. Recorded traces were analyzed by two blinded cardiologists. The computer‐generated automated diagnostic reports from both systems were also compared. Post‐participation feedback was obtained from study participants using a three‐part questionnaire. Results: The sensitivity of the six‐lead electrocardiogram compared to the 12‐lead electrocardiogram, analyzed by two blinded cardiologists, for the detection of normal sinus rhythm was 95.9%, with a specificity of 97.2%. The sensitivity for the detection of atrial fibrillation using the six‐lead ECG was 93.4%, with specificity 96.8%. The six‐lead automated diagnostic report had a sensitivity and specificity of 97.5% and 98.6%, respectively, for correctly diagnosing normal sinus rhythm. For the correct diagnosis of atrial fibrillation, the six‐lead automated diagnostic report had a sensitivity and specificity of 95.4% and 98.8%, respectively. A total of 95.4% of participants found RhythmPad to be comfortable, with only 0.5% preferring the 12‐lead ECG device in comparison to six‐lead ECG acquisitions. Conclusion: The RhythmPad digital health device and its automated diagnostic report were highly accurate in detecting atrial fibrillation when compared to a standard 12‐lead electrocardiogram.