Development of a Standard Protocol for the Harmonic Analysis of Radial Pulse Wave and Assessing Its Reliability in Healthy Humans

Abstract

This study was aimed to establish a standard protocol and to quantitatively assess the reliability of harmonic analysis of the radial pulse wave measured by a harmonic wave analyzer (TD01C system). Both intraobserver and interobserver assessments were conducted to investigate whether the values of harmonics are stable in successive measurements. An intraclass correlation coefficient (ICC) and a Bland–Altman plot were used for this purpose. For the reliability assessments of the intraobserver and the interobserver, 22 subjects (mean age 45 ± 14 years; 14 males and 8 females) were enrolled. The first eleven harmonics of the radial pulse wave presented excellent repeatability (\documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{upgreek} \usepackage{mathrsfs} \setlength{\oddsidemargin}{-69pt} \begin{document} }{}$\text {ICCs}>0.9$ \end{document} and \documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{upgreek} \usepackage{mathrsfs} \setlength{\oddsidemargin}{-69pt} \begin{document} }{}$\text {p}<0.001$ \end{document}) for the intraobserver assessment and high reproducibility (ICCs range from 0.83 to 0.96 and \documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{upgreek} \usepackage{mathrsfs} \setlength{\oddsidemargin}{-69pt} \begin{document} }{}$\text {p}<0.001$ \end{document}) for the interobserver assessment. The Bland–Altman plot indicated that more than 90% of harmonic values fell within two standard deviations of the mean difference. Thus, we concluded that the harmonic analysis of the radial pulse wave using the TD01C system is a feasible and reliable method to assess a hemodynamic characteristic in clinical trial.

Radial Pulse Spectrum Analysis as Risk Markers to Improve the Risk Stratification of Silent Myocardial Ischemia in Type 2 Diabetic Patients

“…The pulse pressure was then recorded on the left-hand radial artery with a pulse wave analyzer TD01C (MII-ANN Technology, Taiwan), which has proven its intrinsic reliability using the artificial pulse generator [27] . The intra-observer and inter-observer reliabilities of TD01C were also demonstrated in the clinical study [28] . The consecutive pressure pulses were obtained during a 12-second period.…”

“…Forth, only a few clinical studies of cardiovascular risk had performed radial pulse analysis [19] – [21] , [40] , which is not widely used in the clinical practice. Radial pulse wave measurement needs standard protocol and training to maintain its reliability [28] . There are some researches focused on the pulse wave analysis using carotid applanation tonometry to assess the risk of cardiovascular disease [41] – [43] .…”

Risk assessment of macrovascular and microvascular events in patients with type 2 diabetes by analyzing the amplitude variation of the fourth harmonic component of radial pulse wave

“…Radial pulse waves were noninvasively measured by medical‐grade devices that had been found to be highly reproducible (Chang and Wang ), and the intra‐observer and inter‐observer reliabilities met the criteria for medical interpretation (Portney and Watkins ; Chang et al ). The standard operating procedures for environmental temperature control and radial pressure wave measurement were as described in previous studies (Chang et al , ). Before the measurement started, each patient was asked to rest for more than 5 min, keeping blood pressure as stable as possible.…”

The First Harmonic of Radial Pulse as an Early Predictor of Silent Coronary Artery Disease and Adverse Cardiac Events in Type 2 Diabetic Patients

“…Therefore, it is necessary to determine the reliabilities of the TD01C measuring instrument for research purposes. In the previous clinical study for intraobserver reliability, the population mean and standard error of the difference of C 1 values between successive measurements was −0.006 ± 0.006 [ 31 ]. In the interobserver reliability study, the population mean, and standard error of the difference of C 1 values between successive measurements was −0.002 ± 0.008 [ 31 ].…”

“…TD01C has been proved its intrinsic reliability using an artificial pulse generator [ 30 ]. The intraobserver and interobserver reliabilities of TD01C were also manifested in the clinical study [ 31 ]. The successive pressure pulses were acquired during the 12-second period.…”