A clinical validation of AViTA home blood pressure monitor for atrial fibrillation detection in adults.

Abstract

Background: 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.

Methods: 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.

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.