Validation of the optical Aktiia bracelet in different body positions for the persistent monitoring of blood pressure.

The diagnosis of hypertension and the adjustment of antihypertensive drugs are evolving from isolated measurements performed at the physician offices to the full phenotyping of patients in real-life conditions. Indeed, the strongest predictor of cardiovascular risk comes from night measurements. The aim of this study was to demonstrate that a wearable device (the Aktiia Bracelet) can accurately estimate BP in the most common body positions of daily life and thus become a candidate solution for the BP phenotyping of patients. We recruited 91 patients with BP ranging from low to hypertensive levels and compared BP values from the Aktiia Bracelet against auscultatory reference values for 4 weeks according to an extended ISO 81060-2 protocol. After initializing on day one, the observed means and standard deviations of differences for systolic BP were of 0.46 ± 7.75 mmHg in the sitting position, - 2.44 ± 10.15 mmHg in the lying, - 3.02 ± 6.10 mmHg in the sitting with the device on the lap, and - 0.62 ± 12.51 mmHg in the standing position. Differences for diastolic BP readings were respectively of 0.39 ± 6.86 mmHg, - 1.93 ± 7.65 mmHg, - 4.22 ± 6.56 mmHg and - 4.85 ± 9.11 mmHg. This study demonstrates that a wearable device can accurately estimate BP in the most common body positions compared to auscultation, although precision varies across positions. While wearable persistent BP monitors have the potential to facilitate the identification of individual BP phenotypes at scale, their prognostic value for cardiovascular events and its association with target organ damage will need cross-sectional and longitudinal studies. Deploying this technology at a community level may be also useful to drive public health interventions against the epidemy of hypertension.

Blood pressure from the optical Aktiia Bracelet: a 1-month validation study using an extended ISO81060-2 protocol adapted for a cuffless wrist device.

OBJECTIVE: The objective of this study (NCT04027777) was to assess the accuracy and precision of the Aktiia Bracelet, a CE-marked noninvasive optical blood pressure (BP) monitor worn at the wrist, over a period of 1 month. METHODS: In this study, participants aged between 21 and 65 years were recruited. The clinical investigation extended the ISO81060-2:2013 standard to the specificities of cuffless devices. Each BP assessment consisted of the simultaneous recording of optical signals with Aktiia Bracelet and double-blinded auscultation by two trained observers in the standard sitting position. The algorithms of Aktiia Bracelet further processed the recorded optical signals to perform a signal quality check and to calculate uncalibrated estimates of systolic BP (SBP) and diastolic BP (DBP). These estimates were transformed into mmHg using a subject-dependent calibration parameter, which was calculated using the first two available reference measurements per subject. RESULTS: Eighty-six participants were included in the analysis. The mean and SD of the differences between Aktiia Bracelet estimates and the reference (ISO81060-2 criterion 1) were 0.46 ± 7.75 mmHg for SBP and 0.39 ± 6.86 mmHg for DBP. The SD of the averaged paired difference per subject (ISO81060-2 criterion 2) were 3.9 mmHg for SBP and 3.6 mmHg for DBP. CONCLUSION: After initialization and during 1 month, the overall accuracy of Aktiia Bracelet satisfied validation criteria 1 and 2 of ISO81060-2 in the sitting position. The Aktiia Bracelet can be recommended for BP measurement in the adult population.

Accuracy testing of a new optical device for noninvasive estimation of systolic and diastolic blood pressure compared to intra-arterial measurements.

OBJECTIVE: The objective of this study was to compare the systolic (S) and diastolic (D) blood pressure (BP) estimations from a new optical device at the wrist with invasive measurements performed on patients scheduled for radial arterial catheterization in the ICU. Optical signals were automatically processed by a library of algorithms from Aktiia SA (OBPM - optical blood pressure monitoring algorithms). METHODS: A total of 31 participants from both sexes, aged 32-87 years, were enrolled in the study (NCT03837769). The measurement protocol consisted of the simultaneous recording of reflective photoplethysmographic signals (PPG) from the cuffless optical device and the reference BP values recorded by a contralateral radial arterial catheter. From the 31 participants, 23 subjects whose reference data quality requirements were adequate were retained for further analysis. The PPG signals from these patients were then automatically processed by the Aktiia OBPM library of algorithms, which generated uncalibrated estimates of SBP and DBP. After the automatic assessment of optical signal quality, 326 pairs of uncalibrated SBP and DBP determinations from 16 patients were available for analysis. These values were finally transformed into calibrated estimations (in mmHg) using arterial catheter SBP and DBP values, respectively. RESULTS: For SBP, a mean difference (±SD) of 0.0 ± 7.1 mmHg between the arterial catheter and the optical device values was found, with 95% limits of agreement in the Bland-Altman method of -11.9 to + 12.2 mmHg (correlation of r = 0.87, P < 0.001). For DBP, a mean difference (±SD) of 0.0 ± 2.9 mmHg between arterial catheter and the optical device values was found, with 95% limits of agreement in the Bland-Altman method of -4.8 to + 5.5 mmHg (correlation of r = 0.98, P < 0.001). CONCLUSION: SBP and DBP values obtained by radial artery catheterization and those obtained from optical measurements at the wrist were compared. The new optical technique appears to be capable of replacing more traditional methods of BP estimation.

Can one detect atrial fibrillation using a wrist-type photoplethysmographic device?

This study aims at evaluating the potential of a wrist-type photoplethysmographic (PPG) device to discriminate between atrial fibrillation (AF) and other types of rhythm. Data from 17 patients undergoing catheter ablation of various arrhythmias were processed. ECGs were used as ground truth and annotated for the following types of rhythm: sinus rhythm (SR), AF, and ventricular arrhythmias (VA). A total of 381/1370/415 10-s epochs were obtained for the three categories, respectively. After pre-processing and removal of segments corresponding to motion artifacts, two different types of feature were derived from the PPG signals: the interbeat interval-based features and the wave-based features, consisting of complexity/organization measures that were computed either from the PPG waveform itself or from its power spectral density. Decision trees were used to assess the discriminative capacity of the proposed features. Three classification schemes were investigated: AF against SR, AF against VA, and AF against (SR&VA). The best results were achieved by combining all features. Accuracies of 98.1/95.9/95.0 %, specificities of 92.4/88.7/92.8 %, and sensitivities of 99.7/98.1/96.2 % were obtained for the three aforementioned classification schemes, respectively. Graphical Abstract Atrial fibrillation detection using PPG signals.

A Novel Short-Term Event Extraction Algorithm for Biomedical Signals.

In this paper, we propose a fast novel nonlinear filtering method named Relative-Energy (Rel-En), for robust short-term event extraction from biomedical signals. We developed an algorithm that extracts short- and long-term energies in a signal and provides a coefficient vector with which the signal is multiplied, heightening events of interest. This algorithm is thoroughly assessed on benchmark datasets in three different biomedical applications, namely ECG QRS-complex detection, EEG K-complex detection, and imaging photoplethysmography (iPPG) peak detection. Rel-En successfully identified the events in these settings. Compared to the state-of-the-art, better or comparable results were obtained on QRS-complex and K-complex detection. For iPPG peak detection, the proposed method was used as a preprocessing step to a fixed threshold algorithm that lead to a significant improvement in overall results. While easily defined and computed, Rel-En robustly extracted short-term events of interest. The proposed algorithm can be implemented by two filters and its parameters can be selected easily and intuitively. Furthermore, Rel-En algorithm can be used in other biomedical signal processing applications where a need of short-term event extraction is present.

Robust heart rate estimation using wrist-type photoplethysmographic signals during physical exercise: an approach based on adaptive filtering.

Photoplethysmographic (PPG) signals are easily corrupted by motion artifacts when the subjects perform physical exercise. This paper introduces a two-step processing scheme to estimate heart rate (HR) from wrist-type PPG signals strongly corrupted by motion artifacts. Adaptive noise cancellation, using normalized least-mean-square algorithm, is first performed to attenuate motion artifacts and reconstruct multiple PPG waveforms from different combinations of corrupted PPG waveforms and accelerometer data. An adaptive band-pass filter is then used to track the common instantaneous frequency component (i.e. HR) of the reconstructed PPG waveforms. The proposed HR estimation scheme was evaluated on two datasets, composed of records from running subjects and subjects performing different kinds of arm/forearm movements and resulted in average absolute errors of 1.40 ± 0.60 and 4.28 ± 3.16 beats-per-minute for these two datasets, respectively. Importantly, the proposed method is fully automatic, induces an average estimation delay of 0.93 s, and is therefore suitable for real-time monitoring applications.

False arrhythmia alarms reduction in the intensive care unit: a multimodal approach.

The purpose of this study was to develop algorithms to lower the incidence of false arrhythmia alarms in the ICU using information from independent sources, namely electrocardiogram (ECG), arterial blood pressure (ABP) and photoplethysmogram (PPG). Our approach relies on robust adaptive signal processing techniques in order to extract accurate heart rate (HR) values from the different waveforms. Based on the quality of available signals, heart rate was either estimated from pulsatile waveforms using an adaptive frequency tracking algorithm or computed from ECGs using an adaptive mathematical morphology approach. Furthermore, we developed a supplementary measure based on the spectral purity of the ECGs to determine whether a ventricular tachycardia or flutter/fibrillation arrhythmia has taken place. Finally, alarm veracity was determined based on a set of decision rules on HR and spectral purity values. The proposed method was evaluated on the PhysioNet/CinC Challenge 2015 database, which is composed of 1250 life-threatening alarm recordings, each categorized into either bradycardia, tachycardia, asystole, ventricular tachycardia or ventricular flutter/fibrillation arrhythmia. This resulted in overall true positive rates of 95%/99% and overall true negative rates of 76%/80% on the real-time and retrospective subsets of the test dataset, respectively.

Sleep Disordered Breathing During Live High-Train Low in Normobaric Versus Hypobaric Hypoxia.

Saugy, Jonas J., Laurent Schmitt, Sibylle Fallet, Raphael Faiss, Jean-Marc Vesin, Mattia Bertschi, Raphaël Heinzer, and Grégoire P. Millet. Sleep disordered breathing during live high-train low in normobaric versus hypobaric hypoxia. High Alt Med Biol. 17:233-238, 2016.-The present study aimed to compare sleep disordered breathing during live high-train low (LHTL) altitude camp using normobaric hypoxia (NH) and hypobaric hypoxia (HH). Sixteen highly trained triathletes completed two 18-day LHTL camps in a crossover designed study. They trained at 1100-1200 m while they slept either in NH at a simulated altitude of 2250 m or in HH. Breathing frequency and oxygen saturation (SpO2) were recorded continuously during all nights and oxygen desaturation index (ODI 3%) calculated. Breathing frequency was lower for NH than HH during the camps (14.6 ± 3.1 breath × min-1 vs. 17.2 ± 3.4 breath × min-1, p < 0.001). SpO2 was lower for HH than NH (90.8 ± 0.3 vs. 91.9 ± 0.2, p < 0.001) and ODI 3% was higher for HH than NH (15.1 ± 3.5 vs. 9.9 ± 1.6, p < 0.001). Sleep in moderate HH is more altered than in NH during a LHTL camp.

Gastrointestinal motility during sleep assessed by tracking of telemetric capsules combined with polysomnography - a pilot study.

Studies of gastrointestinal function during sleep are hampered by lack of applicable techniques. Recent development of a novel ambulatory telemetric capsule system, which can be used in conjunction with polysomnography, offers a solution to this problem. The 3D-Transit system consists of ingestible electromagnetic capsules traceable through a portable extracorporeal receiver while traversing the gut. During sleep monitored by polysomnography, gastrointestinal motility was concurrently investigated using 3D-Transit in nine healthy subjects. Overall, the amplitude of gastric contractions decreased with depth of sleep (light sleep, N2 versus deep sleep, N3; P<0.05). Progression through the small intestine did not change with depth of sleep (Kruskal-Wallis probability =0.1), and there was no association between nocturnal awakenings or arousals and the occurrence of colonic or small intestinal propagating movements. Basal colonic activity was suppressed during both deep sleep (P<0.05) and light sleep (P<0.05) when compared with nocturnal wake periods. In conclusion, the novel ambulatory 3D-Transit system combined with polysomnography allows minimally invasive and completely ambulatory investigation of associations between sleep patterns and gastrointestinal motility.