Division of Cardiology, Department of Internal Medicine, National Taiwan University Hospital, and National Taiwan University College of Medicine, Yun-Lin Branch, Douliu City, Yunlin County.
R&D Software Department, AViTA Corporation, Taipei, Taiwan.
Blood Press Monit. 2024 Dec 1;29(6):299-304. doi: 10.1097/MBP.0000000000000723. Epub 2024 Aug 20.
Atrial fibrillation (AF) is a stroke and heart complication risk but is often overlooked due to subtle symptoms. The accessibility of sphygmomanometers that can detect AF, may play crucial roles in identifying asymptomatic patients. AViTA BPM63B is an automatic blood pressure (BP) monitor for atrial fibrillation detection. This study validated the performance of BPM63B for AF detection using two novel algorithms of time-domain analysis and frequency-domain analysis which evaluate multiple statistics.
The study included 100 participants, with 47 participants being male (47%) and ages ranging from 24 to 89 years (mean ± SD: 59 ± 17 years). Each participant received three consecutive readings from the subject device and a 12-lead ECG assessment. The pulse wave data from subject device was analyzed using the two algorithms. The atrial fibrillation status thus determined was compared to the ECG results interpreted by a physician.
Among the 100 participants, 52 patients had chronic atrial fibrillation, along with 48 outpatients exhibiting sinus rhythm or non-atrial fibrillation arrhythmias. Using the time-domain analysis method for atrial fibrillation detection, we achieved a sensitivity of 94.8% [95% confidence interval (CI), 90.08-97.75%] and a specificity of 98.6% (95% CI, 95.07-99.83%). Similarly, utilizing the frequency-domain analysis method resulted in a sensitivity of 91.6% (95% CI, 86.08-95.46%) and specificity of 94.4% (95% CI, 89.35-97.57%).
These findings suggest that AViTA BPM63B, which integrates two novel algorithms for atrial fibrillation diagnosis, demonstrates high sensitivity and specificity. Utilizing the AViTA BPM63B for BP monitoring could aid in the early detection of atrial fibrillation among outpatients in cardiology clinics.
心房颤动（AF）是中风和心脏并发症的风险因素，但由于症状不明显，往往被忽视。能够检测到 AF 的血压计的普及可能在识别无症状患者方面发挥着至关重要的作用。AViTA BPM63B 是一种用于检测心房颤动的自动血压（BP）监测器。本研究使用时域分析和频域分析两种新算法验证了 BPM63B 在检测 AF 方面的性能，这两种算法评估了多种统计数据。
该研究纳入了 100 名参与者，其中 47 名参与者为男性（47%），年龄在 24 岁至 89 岁之间（平均±标准差：59±17 岁）。每位参与者接受三次来自受试者设备的连续读数和 12 导联心电图评估。使用两种算法分析来自受试者设备的脉搏波数据。通过心电图确定的心房颤动状态与医生解读的结果进行比较。
在 100 名参与者中，52 名患者患有慢性心房颤动，48 名门诊患者表现出窦性节律或非心房颤动性心律失常。使用时域分析方法检测心房颤动，我们的敏感性为 94.8%（95%置信区间（CI）：90.08-97.75%），特异性为 98.6%（95%CI：95.07-99.83%）。同样，使用频域分析方法的敏感性为 91.6%（95%CI：86.08-95.46%），特异性为 94.4%（95%CI：89.35-97.57%）。
这些发现表明，集成了两种用于心房颤动诊断的新算法的 AViTA BPM63B 具有高敏感性和特异性。在心脏病学诊所中，使用 AViTA BPM63B 进行血压监测可能有助于早期发现门诊患者的心房颤动。
