Abdominal aortic aneurysm monitoring via arterial waveform analysis: towards a convenient point-of-care device.

Abdominal aortic aneurysms (AAAs) are lethal but treatable yet substantially under-diagnosed and under-monitored. Hence, new AAA monitoring devices that are convenient in use and cost are needed. Our hypothesis is that analysis of arterial waveforms, which could be obtained with such a device, can provide information about AAA size. We aim to initially test this hypothesis via tonometric waveforms. We study noninvasive carotid and femoral blood pressure (BP) waveforms and reference image-based maximal aortic diameter measurements from 50 AAA patients as well as the two noninvasive BP waveforms from these patients after endovascular repair (EVAR) and from 50 comparable control patients. We develop linear regression models for predicting the maximal aortic diameter from waveform or non-waveform features. We evaluate the models in out-of-training data in terms of predicting the maximal aortic diameter value and changes induced by EVAR. The best model includes the carotid area ratio (diastolic area divided by systolic area) and normalized carotid-femoral pulse transit time ((age·diastolic BP)/(height/PTT)) as input features with positive model coefficients. This model is explainable based on the early, negative wave reflection in AAA and the Moens-Korteweg equation for relating PTT to vessel diameter. The predicted maximal aortic diameters yield receiver operating characteristic area under the curves of 0.83 ± 0.04 in classifying AAA versus control patients and 0.72 ± 0.04 in classifying AAA patients before versus after EVAR. These results are significantly better than a baseline model excluding waveform features as input. Our findings could potentially translate to convenient devices that serve as an adjunct to imaging.

Photoplethysmography Fast Upstroke Time Intervals Can Be Useful Features for Cuff-Less Measurement of Blood Pressure Changes in Humans.

OBJECTIVE: Photoplethysmography (PPG) waveform analysis is being increasingly investigated for continuous, non-invasive, and cuff-less blood pressure (BP) measurement. However, the efficacy of this approach and the useful features and models remain largely unclear. The objectives were to develop easy-to-understand models relating PPG waveform features to BP changes (after a cuff calibration) and to determine their value in BP measurement accuracy. METHODS: The study data comprised finger, toe, and ear PPG waveforms, an ECG waveform, and reference manual cuff BP measurements from 32 human subjects (25% hypertensive) before and after slow breathing, mental arithmetic, cold pressor, and nitroglycerin administration. Stepwise linear regression was employed to create parsimonious models for predicting the intervention-induced BP changes from popular PPG waveform features, pulse arrival time (PAT, time delay between ECG R-wave and PPG foot), and subject demographics. Leave-one-subject-out cross validation was applied to compare the BP change prediction root-mean-squared-errors (RMSEs) of the resulting models to reference models in which PPG waveform features were excluded. RESULTS: Finger b-time (PPG foot to minimum second derivative time interval) and ear "STT" (PPG amplitude divided by maximum derivative), when combined with PAT, reduced the systolic BP change prediction RMSE of reference models by 6-7% (p 0.022). Ear STT together with pulse width reduced the diastolic BP change prediction RMSE of the reference model by 13% (p = 0.003). CONCLUSION: The two PPG fast upstroke time intervals can offer some added value in cuff-less BP trending. SIGNIFICANCE: This study offers important information towards achieving non-invasive and passive BP monitoring without a cuff.

Assessment of Calibration Models for Cuff-Less Blood Pressure Measurement After One Year of Aging.

OBJECTIVE: Many calibration models for cuff-less blood pressure (BP) measurement must be periodically updated with cuff BP values to account for vascular aging. However, the time period required for these "cuff re-calibrations" is largely unknown. The impact of one year of aging on several calibration models was assessed. METHODS: Ten humans (6 males, 57±18 years, 3 hypertensives) were studied during multiple recording sessions that occurred one year apart. In each session, electrocardiography (ECG), ear photoplethysmography (PPG), finger PPG, and toe PPG waveforms and manual cuff BP were recorded before and after slow breathing, mental arithmetic, cold pressor, and nitroglycerin. Linear models based on each PPG waveform, which were previously shown to offer value in predicting the intervention-induced BP changes in a larger subject cohort, were employed. The model coefficients were determined for each subject via one session, and the fully-defined, subject-specific calibration models were then evaluated in the corresponding subjects via the session one year later. RESULTS: Only a linear model relating toe pulse arrival time (PAT) - time delay between ECG R-wave and toe PPG foot - to systolic BP (SBP) remained useful. After the year, this model changed little on average (root-mean-squared-error (RMSE) = 1.5 mmHg) and predicted the cuff BP values better than the average of the initial cuff BP values of the subject (RMSE = 9.6±0.8 mmHg vs. 12.7±1.0 mmHg; p < 0.05). CONCLUSION: These results suggest annual cuff recalibrations for the toe PAT-SBP model. SIGNIFICANCE: Toe PAT may offer a practical recalibration period that fosters user adherence.

Evaluation of the Accuracy of Cuffless Blood Pressure Measurement Devices: Challenges and Proposals.

Several novel cuffless wearable devices and smartphone applications claiming that they can measure blood pressure (BP) are appearing on the market. These technologies are very attractive and promising, with increasing interest among health care professionals for their potential use. Moreover, they are becoming popular among patients with hypertension and healthy people. However, at the present time, there are serious issues about BP measurement accuracy of cuffless devices and the 2021 European Society of Hypertension Guidelines on BP measurement do not recommend them for clinical use. Cuffless devices have special validation issues, which have been recently recognized. It is important to note that the 2018 Universal Standard for the validation of automated BP measurement devices developed by the American Association for the Advancement of Medical Instrumentation, the European Society of Hypertension, and the International Organization for Standardization is inappropriate for the validation of cuffless devices. Unfortunately, there is an increasing number of publications presenting data on the accuracy of novel cuffless BP measurement devices, with inadequate methodology and potentially misleading conclusions. The objective of this review is to facilitate understanding of the capabilities and limitations of emerging cuffless BP measurement devices. First, the potential and the types of these devices are described. Then, the unique challenges in evaluating the BP measurement accuracy of cuffless devices are explained. Studies from the literature and computer simulations are employed to illustrate these challenges. Finally, proposals are given on how to evaluate cuffless devices including presenting and interpreting relevant study results.

Conventional pulse transit times as markers of blood pressure changes in humans.

Pulse transit time (PTT) represents a potential approach for cuff-less blood pressure (BP) monitoring. Conventionally, PTT is determined by (1) measuring (a) ECG and ear, finger, or toe PPG waveforms or (b) two of these PPG waveforms and (2) detecting the time delay between the waveforms. The conventional PTTs (cPTTs) were compared in terms of correlation with BP in humans. Thirty-two volunteers [50% female; 52 (17) (mean (SD)) years; 25% hypertensive] were studied. The four waveforms and manual cuff BP were recorded before and after slow breathing, mental arithmetic, cold pressor, and sublingual nitroglycerin. Six cPTTs were detected as the time delays between the ECG R-wave and ear PPG foot, R-wave and finger PPG foot [finger pulse arrival time (PAT)], R-wave and toe PPG foot (toe PAT), ear and finger PPG feet, ear and toe PPG feet, and finger and toe PPG feet. These time delays were also detected via PPG peaks. The best correlation by a substantial extent was between toe PAT via the PPG foot and systolic BP [- 0.63 ± 0.05 (mean ± SE); p < 0.001 via one-way ANOVA]. Toe PAT is superior to other cPTTs including the popular finger PAT as a marker of changes in BP and systolic BP in particular.

PPG Sensor Contact Pressure Should Be Taken Into Account for Cuff-Less Blood Pressure Measurement.

OBJECTIVE: Photo-plethysmography (PPG) sensors are often used to detect pulse transit time (PTT) for potential cuff-less blood pressure (BP) measurement. It is known that the contact pressure (CP) of the PPG sensor markedly alters the PPG waveform amplitude. The objective was to test the hypothesis that PTT detected via PPG sensors is likewise impacted by CP. METHODS: A device was built to measure the time delay between ECG and finger PPG waveforms (i.e., pulse arrival time (PAT) - a popular surrogate of PTT) and the PPG sensor CP at different CP levels. These measurements and finger cuff BP were recorded while the CP was slowly varied in 17 healthy subjects. RESULTS: Over a physiologic range of CP, the maximum deviations of PAT detected at the PPG foot and peak were 22±2 and 40±7 ms (p<0.05), which translate to ∼11 and ∼20 mmHg BP error based on the literature. The curve relating PAT detected at the PPG foot to CP was U-shaped with minimum near finger diastolic BP. A conceptual model accounting for finger artery viscoelasticity and nonlinearity explained this curve. CONCLUSION: Since the regulatory bias error for BP measurement is limited to 5 mmHg, PPG sensor CP should be taken into account for cuff-less BP measurement via PTT. SIGNIFICANCE: This study suggests that widely pursued PPG-based BP measurement devices including those that detect PTT should maintain the CP or include a CP measurement in the calibration equation for deriving BP.

Formulas to Explain Popular Oscillometric Blood Pressure Estimation Algorithms.

Oscillometry is the blood pressure (BP) measurement principle of most automatic cuff devices. The oscillogram (which is approximately the blood volume oscillation amplitude-external pressure function) is measured, and BP is then estimated via an empirical algorithm. The objective was to establish formulas to explain three popular empirical algorithms in the literature-the maximum amplitude, derivative, and fixed ratio algorithms. A mathematical model of the oscillogram was developed and analyzed to derive parametric formulas for explaining each algorithm. Exemplary parameter values were obtained by fitting the model to measured oscillograms. The model and formulas were validated by showing that their predictions correspond to measurements. The formula for the maximum amplitude algorithm indicates that it yields a weighted average of systolic and diastolic BP (0.45 and 0.55 weighting) instead of commonly assumed mean BP. The formulas for the derivative algorithm indicate that it can accurately estimate systolic and diastolic BP (<1.5 mmHg error), if oscillogram measurement noise can be obviated. The formulas for the fixed ratio algorithm indicate that it can yield inaccurate BP estimates, because the ratios change substantially (over a 0.5-0.6 range) with arterial compliance and pulse pressure and error in the assumed ratio translates to BP error via large amplification (>40). The established formulas allow for easy and complete interpretation of perhaps the three most popular oscillometric BP estimation algorithms in the literature while providing new insights. The model and formulas may also be of some value toward improving the accuracy of automatic cuff BP measurement devices.

An iPhone Application for Blood Pressure Monitoring via the Oscillometric Finger Pressing Method.

We developed an iPhone X application to measure blood pressure (BP) via the "oscillometric finger pressing method". The user presses her fingertip on both the front camera and screen to increase the external pressure of the underlying artery, while the application measures the resulting variable-amplitude blood volume oscillations via the camera and applied pressure via the strain gauge array under the screen. The application also visually guides the fingertip placement and actuation and then computes BP from the measurements just like many automatic cuff devices. We tested the application, along with a finger cuff device, against a standard cuff device. The application yielded bias and precision errors of -4.0 and 11.4 mmHg for systolic BP and -9.4 and 9.7 mmHg for diastolic BP (n = 18). These errors were near the finger cuff device errors. This proof-of-concept study surprisingly indicates that cuff-less and calibration-free BP monitoring may be feasible with many existing and forthcoming smartphones.