Sabar Muhammad I, Ara Farhana, Henderson Alice, Ahmed Omar, Potter Christina, John Isaac, Mitchell Andrew R J, Yáñez-Muñoz Rafael J, Kaba Riyaz A
Ashford and St. Peter's Hospital, Chertsey, UK.
Centre of Gene and Cell Therapy, Centre for Biomedical Sciences, Biological Sciences, Royal Holloway, University of London, Egham, UK.
Pacing Clin Electrophysiol. 2019 Oct;42(10):1383-1389. doi: 10.1111/pace.13800. Epub 2019 Sep 16.
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.
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.
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.
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.
心房颤动在社区中通常无症状且未被诊断出来，这会增加这些患者发生心力衰竭和中风的风险。我们评估了一种新型六通道心电图数字健康筛查设备RhythmPad检测心房颤动的有效性、耐受性和准确性。
招募了752名到心脏病科就诊的参与者。进行了两次记录——一次使用RhythmPad设备进行六导联心电图记录，另一次进行标准12导联心电图记录。由两名不知情的心脏病专家分析记录的心电图轨迹。还比较了两个系统生成的计算机自动诊断报告。使用一份三部分问卷从研究参与者那里获得参与后的反馈。
由两名不知情的心脏病专家分析，与12导联心电图相比，六导联心电图检测正常窦性心律的敏感性为95.9%，特异性为97.2%。使用六导联心电图检测心房颤动的敏感性为93.4%，特异性为96.8%。六导联自动诊断报告正确诊断正常窦性心律的敏感性和特异性分别为97.5%和98.6%。对于心房颤动的正确诊断，六导联自动诊断报告的敏感性和特异性分别为95.4%和98.8%。共有95.4%的参与者认为RhythmPad使用起来很舒适，与六导联心电图采集相比，只有0.5%的参与者更喜欢12导联心电图设备。
与标准12导联心电图相比，RhythmPad数字健康设备及其自动诊断报告在检测心房颤动方面具有很高的准确性。
