Non-Invasive Central Venous Pressure Measurement Using Enclosed-Zone Central Venous Pressure (ezCVPTM).

BACKGROUND: Central venous pressure (CVP) is measured to assess intravascular fluid status. Although the clinical gold standard for evaluating CVP is invasive measurement using catheterization, the use of catheterization is limited in a clinical setting because of its invasiveness. We developed novel non-invasive technique, enclosed-zone (ezCVPTM) measurement for estimating CVP. The purpose of this study was to assess the feasibility of ezCVP and the relationship between ezCVP and CVP measured by a catheter.Methods and Results:We conducted 291 measurements in 97 patients. Linear regression analysis revealed that ezCVP was significantly correlated with CVP (r=0.65, P<0.0001). The Bland-Altman analysis showed that ezCVP had an underestimation bias of -2.5 mmHg with 95% limits of agreement of -14.1 mmHg and 9.6 mmHg for CVP (P<0.0001). The areas under the curves of receiver operating curve with ezCVP to detect the CVP ≥12 cmH2O (8.8 mmHg) and CVP >10 mmHg were 0.81 or 0.88, respectively. The sensitivity, specificity and positive likelihood ratio of ezCVP for the CVP ≥8.8 mmHg and CVP >10 mmHg were 0.59, 0.96 and 14.8 with a cut-off value of 11.9 and 0.79, 0.97 and 26.3 with a cut-off value of 12.7. CONCLUSIONS: These findings suggest that ezCVP measurement is feasible and useful for assessing CVP.

Assessment of Lower-limb Vascular Endothelial Function Based on Enclosed Zone Flow-mediated Dilation.

This paper proposes a novel non-invasive method for assessing the vascular endothelial function of lower-limb arteries based on the dilation rate of air-cuff plethysmograms measured using the oscillometric approach. The principle of evaluating vascular endothelial function involves flow-mediated dilation. In the study conducted, blood flow in the dorsal pedis artery was first monitored while lower-limb cuff pressure was applied using the proposed system. The results showed blood flow was interrupted when the level of pressure was at least 50 mmHg higher than the subject's lower-limb systolic arterial pressure and that blood flow velocity increased after cuff release. Next, values of the proposed index, %ezFMDL, for assessing the vascular endothelial function of lower-limb arteries were determined from 327 adult subjects: 87 healthy subjects, 150 subjects at high risk of arteriosclerosis and 90 patients with cardiovascular disease (CAD). The mean values and standard deviations calculated using %ezFMDL were 30.5 ± 12.0% for the healthy subjects, 23.6 ± 12.7% for subjects at high risk of arteriosclerosis and 14.5 ± 15.4% for patients with CAD. The %ezFMDL values for the subjects at high risk of arteriosclerosis and the patients with CAD were significantly lower than those for the healthy subjects (p < 0.01). The proposed method may have potential for clinical application.

Endothelial Function Assessed by Automatic Measurement of Enclosed Zone Flow-Mediated Vasodilation Using an Oscillometric Method Is an Independent Predictor of Cardiovascular Events.

BACKGROUND: A new device for automatic measurement of flow-mediated vasodilation (FMD) using an oscillometric method has been developed to solve technical problems of conventional FMD measurement. This device measures enclosed zone FMD (ezFMD). The purpose of this study was to evaluate the prognostic value of endothelial function assessed by ezFMD for future cardiovascular events. METHODS AND RESULTS: We measured ezFMD in 272 participants who underwent health-screening examinations. First, we investigated cross-sectional associations between ezFMD and cardiovascular risk factors, and then we assessed the associations between ezFMD and first major cardiovascular events (death from cardiovascular causes, stroke, and coronary revascularization). Univariate regression analysis revealed that ezFMD was significantly correlated with age, triglycerides, glucose, smoking pack-years, estimated glomerular filtration rate, high-sensitivity C-reactive protein, and Framingham risk score. During a median follow-up period of 36.1 months (interquartile range 18.8-40.1 months), 12 participants died (6 from cardiovascular causes), 3 had stroke, 8 had coronary revascularization, and 10 were hospitalized for heart failure. There was no episode of acute coronary syndrome during the study period. Participants were divided into tertiles (low, intermediate, and high) based on ezFMD. Kaplan-Meier curves for first major cardiovascular events among the 3 groups were significantly different (P=0.004). After adjustment for cardiovascular risk factors, the low group was significantly associated with an increased risk of first major cardiovascular events compared with the high group (hazard ratio 6.47; 95% CI 1.09-125.55; P=0.038). CONCLUSIONS: These findings suggest that endothelial function assessed by ezFMD may be useful as a surrogate marker of future cardiovascular events. CLINICAL TRIAL REGISTRATION: URL: https://upload.umin.ac.jp. Unique identifier: UMIN000004902.

Monitoring of peripheral vascular condition using a log-linearized arterial viscoelastic index during endoscopic thoracic sympathectomy.

This paper proposes a novel technique to support the monitoring of peripheral vascular conditions using biological signals such as electrocardiograms, arterial pressure values and pulse oximetry plethysmographic waveforms. In this approach, a second-order log-linearized model (referred to here as a log-linearized peripheral arterial viscoelastic model) is used to describe the non-linear viscoelastic relationship between blood pressure waveforms and photo-plethysmographic waveforms. The proposed index enables estimation of peripheral arterial wall stiffness changes induced by sympathetic nerve activity. The validity of the method is discussed here based on the results of peripheral vascular condition monitoring conducted during endoscopic thoracic sympathectomy (ETS). The results of ETS monitoring showed significant changes in stiffness variations between the periods before and during the procedures observed (p < 0.01) as well as during and after them (p < 0.01), so that it was confirmed that sympathetic nerve activity is drastically decreased in the area around the monitoring site after the thoracic sympathetic nerve trunk on the monitoring side is successfully blocked. In addition, no change was observed in the values of the proposed index during the ETS procedure on the side opposite that of the monitoring site. The experimental results obtained clearly show the proposed method can be used to assess changes in sympathetic nerve activity during ETS.

A log-linearized arterial viscoelastic model for evaluation of the carotid artery.

This paper proposes a method for qualitatively estimating the mechanical properties of arterial walls on a beat-to-beat basis through noninvasive measurement of continuous arterial pressure and arterial diameter using an ultrasonic device. First, in order to describe the nonlinear relationships linking arterial pressure waveforms and arterial diameter waveforms as well as the viscoelastic characteristics of arteries, we developed a second-order nonlinear model (called the log-linearized arterial viscoelastic model) to allow estimation of arterial wall viscoelasticity. Next, to verify the validity of the proposed method, the viscoelastic indices of the carotid artery were estimated. The results showed that the proposed model can be used to accurately approximate the mechanical properties of arterial walls. It was therefore deemed suitable for qualitative evaluation of arterial viscoelastic properties based on noninvasive measurement of arterial pressure and arterial diameter.

A novel noninvasive and simple method for assessment of endothelial function: enclosed zone flow-mediated vasodilation (ezFMD) using an oscillation amplitude measurement.

BACKGROUND: It is clinically important to estimate the degree of endothelial dysfunction. Several methods have been used to assess endothelial function in humans. Recently, we developed a new noninvasive method for measurement of vascular response to reactive hyperemia in the brachial artery, named enclosed zone flow-mediated vasodilation (ezFMD). The purpose of this study was to determine the validity of ezFMD for assessment of endothelial function. METHODS AND RESULTS: We measured ezFMD by a new device using an oscillometric method and conventional FMD using ultrasonography in 306 subjects, including patients with hypertension, dyslipidemia, and diabetes mellitus (218 men and 88 women, 30 ± 16 yr). Univariate regression analysis revealed that ezFMD significantly correlated with age (r = -0.42, P < 0.0001), body mass index (r = -0.13, P = 0.028), systolic blood pressure (r = -0.15, P = 0.009), diastolic blood pressure (r = -0.14, P = 0.011), fasting glucose level (r = -0.27, P = 0.006), smoking (r = -0.21, P = 0.007) and baseline pulse wave amplitude (r = -0.51, P < 0.0001). ezFMD significantly correlated with conventional FMD (r = 0.34, P < 0.0001). Multiple regression analysis revealed that age (P = 0.002), body mass index (P = 0.013), systolic blood pressure (P = 0.009), smoking (P = 0.004) and baseline pulse wave amplitude (P < 0.001) were independent predictors of ezFMD. CONCLUSIONS: These findings suggest that measurement of ezFMD, a novel noninvasive and simple method, may be useful for determination of vascular diameter response to reactive hyperemia. Since ezFMD is automatically measured by a device with an oscillometric method, measurement of ezFMD is easier and less biased than that of conventional FMD.

Novel non-invasive method of measurement of endothelial function: enclosed-zone flow-mediated dilatation (ezFMD).

Measurement of flow-mediated dilatation (FMD) is the conventional non-invasive method for assessment of endothelial function; however, it requires an expensive ultrasound system and high levels of technical skill. Therefore, we developed a novel method for measurement of endothelial function, namely, measurement of ezFMD. ezFMD estimates the degree of vasodilatation from the oscillation signals transmitted to a sphygmomanometer cuff attached to the upper arm. The objective of this study was to validate the principle underlying the measurement of ezFMD, and to evaluate the repeatability of the ezFMD measurements. We observed the blood vessel behavior and oscillometric pattern in ten subjects. When the cuff was inflated to the level of the mean blood pressure, the oscillation amplitude increased with increasing degree of vasodilatation. In experiment to evaluate the repeatability of the ezFMD measurement, the average difference between the paired measurements was 3.7 %, the standard deviation was 11.5 %, and the average coefficient of variation value for the 11 paired measurements was 23.7 %. These results suggest the validity of the principle underlying the measurement of the ezFMD for the assessment of endothelial function. And, this study suggests that the repeatability of the ezFMD measurements is superior to that of the conventional measurement of FMD.

The comparison of a novel continuous cardiac output monitor based on pulse wave transit time and echo Doppler during exercise.

A new technology called estimated continuous cardiac output (esCCO) uses pulse wave transit time (PWTT) obtained from an electrocardiogram and pulse oximeter to measure cardiac output (CO) non-invasively and continuously. This study was performed to evaluate the accuracy of esCCO during exercise testing. We compared esCCO with CO measured by the echo Doppler aortic velocity-time integral (VTIao_CO). The correlation coefficient between esCCO and VTIao_CO was r= 0.87 (n= 72). Bias and precision were 0.33 ± 0.95 L/min and percentage error was 31%. The esCCO could detect change in VTIao_CO larger than 1 L/min with a concordance rate of 88%. In polar plot, 83% of data are within 0.5 L/min, and 100% of data are within 1 L/min. Those results show the acceptable accuracy and trend ability of esCCO. Change in pre-ejection period (PEP) measured by using M-mode of Diagnostic Ultrasound System accounted for approximately half of change in PWTT. This indicates that PEP included in PWTT has an impact on the accuracy of esCCO measurement. In this study, the validity of esCCO during exercise testing was assessed and shown to be acceptable. The result of this study suggests that we can expand its application.

A novel continuous cardiac output monitor based on pulse wave transit time.

Monitoring cardiac output (CO) is important for the management of patient circulation in an operation room (OR) or intensive care unit (ICU). We assumed that the change in pulse wave transit time (PWTT) obtained from an electrocardiogram (ECG) and a pulse oximeter wave is correlated with the change in stroke volume (SV), from which CO is derived. The present study reports the verification of this hypothesis using a hemodynamic analysis theory and animal study. PWTT consists of a pre-ejection period (PEP), the pulse transit time through an elasticity artery (T(1)), and the pulse transit time through peripheral resistance arteries (T(2)). We assumed a consistent negative correlation between PWTT and SV under all conditions of varying circulatory dynamics. The equation for calculating SV from PWTT was derived based on the following procedures. 1. Approximating SV using a linear equation of PWTT. 2. The slope and y-intercept of the above equation were determined under consideration of vessel compliance (SV was divided by Pulse Pressure (PP)), animal type, and the inherent relationship between PP and PWTT. Animal study was performed to verify the above-mentioned assumption. The correlation coefficient of PWTT and SV became r = -0.710 (p 〈 0.001), and a good correlation was admitted. It has been confirmed that accurate continuous CO and SV measurement is only possible by monitoring regular clinical parameters (ECG, SpO2, and NIBP).

A novel online method to monitor autonomic nervous activity based on arterial wall impedance and heart rate variability.

This paper proposes a new method of evaluating autonomic nervous activity using the mechanical impedance of arterial walls and heart rate variability. The cardiovascular system is indispensable to life maintenance functions, and homeostasis is maintained by the autonomic nervous system. Accordingly, it is very important to be able to make diagnosis based on autonomic nervous activity within the body's circulation. The proposed method was evaluated in surgical operations; the mechanical impedance of the arterial wall was estimated from arterial blood pressure and a photoplethysmogram, and heart rate variability was estimated using electrocardiogram R-R interval spectral analysis. In this paper, we monitored autonomic nervous system activity using the proposed system during endoscopic transthoracic sympathetic block surgery in eight patients with hyperhidrosis. The experimental results indicated that the proposed system can be used to estimate autonomic nervous activity in response to events during operations.