McDonagh Sinéad T J, Rhodes Shelley, Warren Fiona C, Keenan Sam, Pentecost Claire, Keeling Philip, James Martin, Taylor Rod S, Clark Christopher E
Primary Care Research Group, Exeter, United Kingdom.
Exeter Clinical Trials Unit, College of Medicine and Health, University of Exeter Medical School, Exeter, United Kingdom.
Cardiovasc Digit Health J. 2022 May 26;3(4):171-178. doi: 10.1016/j.cvdhj.2022.05.002. eCollection 2022 Aug.
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).
To assess the diagnostic performance of the Plessey imPulse lead I ECG device compared with a 12-lead ECG in detecting AF.
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.
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.
The imPulse device has moderate sensitivity and good specificity compared with ECG AF detection in a hospital setting.
心房颤动（AF）会增加血栓栓塞和中风风险；口服抗凝治疗可降低这种风险，但前提是要检测出AF。一种便携式即时检测设备若能准确检测和识别AF，通过减少对后续12导联心电图（ECG）的需求，可减轻工作量并减少诊断延迟。
评估Plessey imPulse I导联ECG设备与12导联ECG在检测AF方面的诊断性能。
横断面诊断准确性研究。参与者同时进行12导联ECG和imPulse设备记录。imPulse设备将AF报告为“可能”“有可能”“不太可能”或“不太可能是未控制的AF”。对imPulse和ECG的参考结果进行交叉制表；根据不同的imPulse设备报告分类和心率亚组，估计敏感性、特异性、阳性/阴性预测值以及95%置信区间（CI）的阳性/阴性似然比。
共招募了217名参与者（平均年龄70.2岁[标准差12.7]），男性占56%，门诊患者占57%，住院患者占43%），199名纳入分析。199名参与者中有41名（20.6%）通过ECG诊断为AF，imPulse报告为可能、很可能或不太可能是未控制的AF的有49名（24.6%）。与ECG相比，imPulse检测可能、很可能或不太可能是未控制的AF与不太可能是AF的敏感性和特异性分别为80.5%（95%CI，65.1%-91.2%）和89.9%（84.1%-94.1%）。当比较很可能或不太可能是未控制的AF与可能或不太可能是AF时，敏感性和特异性分别为63.4%（46.9%-77.9%）和98.1%（94.6%-99.6%）。
在医院环境中与ECG检测AF相比，imPulse设备具有中等敏感性和良好的特异性。
