Advances in Non-Invasive Blood Pressure Monitoring

Quan, Xina; Liu, Junjun; Roxlo, Thomas; Siddharth, Siddharth; Leong, Weyland; Muir, Arthur; Cheong, So‐Min; Rao, Anoop

doi:10.3390/s21134273

Cited by 40 publications

(29 citation statements)

References 76 publications

(111 reference statements)

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“…However, it was recently emphasized that using these standards for new devices is inappropriate, and that new standards are needed ( 11 ). More recently, some devices were cleared by the United States Food and Drug Administration (FDA) and the European Union (Conformity Marketing, CE-label) ( 12 ). The Samsung Galaxy Watch Active 2 that was used in this study recently received CE-clearance, but algorithms and validation studies are not openly disclosed ( 8 ).…”

Section: Introductionmentioning

confidence: 99%

Smartwatch-Based Blood Pressure Measurement Demonstrates Insufficient Accuracy

Falter

Scherrenberg

Driesen

et al. 2022

Front. Cardiovasc. Med.

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BackgroundNovel smartwatch-based cuffless blood pressure (BP) measuring devices are coming to market and receive FDA and CE labels. These devices are often insufficiently validated for clinical use. This study aims to investigate a recently CE-cleared smartwatch using cuffless BP measurement in a population with normotensive and hypertensive individuals scheduled for 24-h BP measurement.MethodsPatients that were scheduled for 24-h ambulatory blood pressure monitoring (ABPM) were recruited and received an additional Samsung Galaxy Watch Active 2 smartwatch for simultaneous BP measurement on their opposite arm. After calibration, patients were asked to measure as much as possible in a 24-h period. Manual activation of the smartwatch is necessary to measure the BP. Accuracy was calculated using sensitivity, specificity, positive and negative predictive values and ROC curves. Bland-Altman method and Taffé methods were used for bias and precision assessment. BP variability was calculated using average real variability, standard deviation and coefficient of variation.ResultsForty patients were included. Bland-Altman and Taffé methods demonstrated a proportional bias, in which low systolic BPs are overestimated, and high BPs are underestimated. Diastolic BPs were all overestimated, with increasing bias toward lower BPs. Sensitivity and specificity for detecting systolic and/or diastolic hypertension were 83 and 41%, respectively. ROC curves demonstrate an area under the curve (AUC) of 0.78 for systolic hypertension and of 0.93 for diastolic hypertension. BP variability was systematically higher in the ABPM measurements compared to the smartwatch measurements.ConclusionThis study demonstrates that the BP measurements by the Samsung Galaxy Watch Active 2 show a systematic bias toward a calibration point, overestimating low BPs and underestimating high BPs, when investigated in both normotensive and hypertensive patients. Standards for traditional non-invasive sphygmomanometers are not met, but these standards are not fully applicable to cuffless devices, emphasizing the urgent need for new standards for cuffless devices. The smartwatch-based BP measurement is not yet ready for clinical usage. Future studies are needed to further validate wearable devices, and also to demonstrate new possibilities of non-invasive, high-frequency BP monitoring.

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Section: Introductionmentioning

confidence: 99%

Smartwatch-Based Blood Pressure Measurement Demonstrates Insufficient Accuracy

Falter

Scherrenberg

Driesen

et al. 2022

Front. Cardiovasc. Med.

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“…Non‐invasive wireless blood pressure monitoring helps in patient diagnosis and treatment by compensating for shortcomings such as ischemic risk and enabling natural body movement. [ 186 , 187 , 188 , 189 ] In pediatrics, since the skin is very sensitive and fragile, the development of a very safe, accurate, soft, and comfortable blood pressure monitoring method and device is essential. Figure 2c shows the continuous monitoring of vital signals by attaching an optimized wireless skin interface device, which can be used in the pediatric intensive care unit (PICU), to various parts of the infant's body.…”

Section: Encapsulation For Wearable Bioelectronicsmentioning

confidence: 99%

Ultra‐Thin Flexible Encapsulating Materials for Soft Bio‐Integrated Electronics

2022

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Recently, bioelectronic devices extensively researched and developed through the convergence of flexible biocompatible materials and electronics design that enables more precise diagnostics and therapeutics in human health care and opens up the potential to expand into various fields, such as clinical medicine and biomedical research. To establish an accurate and stable bidirectional bio-interface, protection against the external environment and high mechanical deformation is essential for wearable bioelectronic devices. In the case of implantable bioelectronics, special encapsulation materials and optimized mechanical designs and configurations that provide electronic stability and functionality are required for accommodating various organ properties, lifespans, and functions in the biofluid environment. Here, this study introduces recent developments of ultra-thin encapsulations with novel materials that can preserve or even improve the electrical performance of wearable and implantable bio-integrated electronics by supporting safety and stability for protection from destruction and contamination as well as optimizing the use of bioelectronic systems in physiological environments. In addition, a summary of the materials, methods, and characteristics of the most widely used encapsulation technologies is introduced, thereby providing a strategic selection of appropriate choices of recently developed flexible bioelectronics.

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“…There are several review articles available on the Web of Science and Google Scholar that discuss the methodologies for estimating SBP, DBP, and MAP values without using a cuff [ 42 , 43 , 44 , 45 , 46 , 47 ]. Some studies mentioned two techniques (applanation tonometry and the volume clamp method) along with the cuffless methods [ 48 , 49 , 50 , 51 , 52 , 53 ]. However, these two methods are discussed to review the old techniques, and the main purpose of the reviews is to review the papers that can measure SBP, DBP, and MAP values rather than focusing to estimate the complete BP waveforms.…”

Section: Searching Strategymentioning

confidence: 99%

A Review of Noninvasive Methodologies to Estimate the Blood Pressure Waveform

Athaya

Choi

2022

Sensors

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Accurate estimation of blood pressure (BP) waveforms is critical for ensuring the safety and proper care of patients in intensive care units (ICUs) and for intraoperative hemodynamic monitoring. Normal cuff-based BP measurements can only provide systolic blood pressure (SBP) and diastolic blood pressure (DBP). Alternatively, the BP waveform can be used to estimate a variety of other physiological parameters and provides additional information about the patient’s health. As a result, various techniques are being proposed for accurately estimating the BP waveforms. The purpose of this review is to summarize the current state of knowledge regarding the BP waveform, three methodologies (pressure-based, ultrasound-based, and deep-learning-based) used in noninvasive BP waveform estimation research and the feasibility of employing these strategies at home as well as in ICUs. Additionally, this article will discuss the physical concepts underlying both invasive and noninvasive BP waveform measurements. We will review historical BP waveform measurements, standard clinical procedures, and more recent innovations in noninvasive BP waveform monitoring. Although the technique has not been validated, it is expected that precise, noninvasive BP waveform estimation will be available in the near future due to its enormous potential.

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Advances in Non-Invasive Blood Pressure Monitoring

Cited by 40 publications

References 76 publications

Smartwatch-Based Blood Pressure Measurement Demonstrates Insufficient Accuracy

Smartwatch-Based Blood Pressure Measurement Demonstrates Insufficient Accuracy

Ultra‐Thin Flexible Encapsulating Materials for Soft Bio‐Integrated Electronics

A Review of Noninvasive Methodologies to Estimate the Blood Pressure Waveform

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