ABSTRACT
BACKGROUND: Atrial fibrillation (AF) is a stroke and heart complication riskbut 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. METHODS: The study included 100 subject, with 47 participants being male (47%) and ages ranging from 24 to 89â years (meanâ ±â SD: 59â ±â 17â 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. RESULTS: 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%). CONCLUSIONS: 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.
ABSTRACT
OBJECTIVE: To determine the accuracy of the AViTA BP636 upper-arm home blood pressure (BP) monitor in general populations with small to extra-large arms according to the ANSI/AAMI/ISO Universal Standard (ISO 81060-2 : 2018/Amd1 : 2020). METHODS: The AViTA BPM636 was utilized on 85 adult participants with upper-arm circumferences ranging from 15 to 52 cm, and four cuffs of different sizes (small: 15-22 cm, normal: 22-33 cm, large: 33-42 cm, and extra large: 42-52 cm) were used in this study. The recruitment fulfills the criteria of the ANSI/AAMI/ISO Universal Standard 81060-2 : 2018/Amd1 : 2020 in the general population using the same arm sequential BP measurement method. RESULTS: For validation criterion 1, the mean ± SD of the differences between the test device and reference blood pressure readings was -0.35 ± 4.68/0.56 ± 3.93 mmHg (systolic/diastolic) for adults. The mean difference of SBP between the test device and the reference device was -0.35 mmHg with a SD of 3.50 mmHg, wh{ich was within the acceptable range for criterion 2 (i.e. less than 6.93 mmHg) Similarly, the mean difference in DBP was 0.56 mmHg with a SD of 3.38 mmHg, which also met the criterion 2 (i.e. within 6.91 mmHg). CONCLUSION: AViTA BPM636 passed the criteria of the ANSI/AAMI/ISO 81060-2 : 2018/Amd 1 : 2020 protocol. It can be recommended for home-based BP measurements in the general population and people with extra-large arms ranging from 42 to 52 cm.
ABSTRACT
OBJECTIVE: To evaluate the accuracy of the AViTA oscillometric upper arm home blood pressure (BP) monitor in adult and pregnant populations according to the American National Standards Institute/Association for the Advancement of Medical Instrumentation/ International Organization for Standardization (ANSI/AAMI/ISO) Universal Standard (ISO 81060-2:2013). METHODS: BP measurements on the upper arm were performed on 85 adult subjects and 46 pregnant subjects. The AViTA BPM636 and a standard mercury reference sphygmomanometer were applied and followed the same arm sequential BP measurement method. The universal cuff of the test device was used for arm circumference of 22-42â cm. RESULTS: For validation criterion 1, the mean ± SD of the differences between the test device and reference BP readings was 1.1â ±â 5.49/2.9â ±â 5.17â mmHg (systolic/diastolic) for adults; and -2.2â ±â 5.93/1.5â ±â 4.92â mmHg (systolic/diastolic) for pregnant women. For criterion 2, the SD of the averaged BP differences between the test device and reference BP per adult subject was 4.45/4.20â mmHg (systolic/diastolic) and per pregnant women was 4.66/3.96. CONCLUSION: The AViTA BPM636 had passed the criteria of the ANSI/AAMI/ISO 81060-2:2013 protocol and can be recommended for home BP measurements in adults and pregnant populations.