Instrumental methods for diagnosis and assessment of cardiovascular risk in hypertensive patients: authors’ research report (part 2)
Background. In the previous part we have described in details all the parameters that can be obtained by the contour and speed pulse wave analysis and noted the domestic device for estimating these parameters. This part reveals the results of the open clinical trial of BAT41-2 device produced by IKS-TECHNO (Kyiv) in the mode of determining the arterial stiffness and central blood pressure (BP) in hypertensive patients. The purpose of this study was to determine the potential for use BAT41-2 device in order to assess central BP and arterial stiffness parameters in comparison with SphigmoCor and Complior devices. Materials and methods. The study consisted of the following stages: screening (to check eligibility for the inclusion in the study), the study observation period included two visits. Subjects who responded to all the inclusion criteria and did not have any exclusion criteria were invited for the first visit, when following measurements were obtained by the tree devices (SphigmoCor, Complior and BAT41-2 switched to mode of determining of the arterial stiffness): office systolic BP, diastolic BP and heart rate, central BP, augmentation index, pulse wave velocity in the arteries of elastic and muscular types, ejection time, subendocardial viability ratio (Buckberg index). Besides signal of SphigmoCor and Complior devices was calibrated by supine office systolic BP, diastolic BP and heart rate measurements obtained with the mean of the automatic machine M-10 (Omron, Japan; top accuracy class A/A) using oscillometric method. Results. The final analysis included 69 patients. Results of the office BP and heart rate measuring with the Omron M-10 device almost completely corresponded to the results obtained by BAT41-2. There was a strong significant correlation between the results of central systolic BP by BAT41-2 and SphigmoCor devices (r = 0.98; p < 0.001). Also, there was a strong correlation of the augmentation index measured by BAT41-2 with the results obtained using SphigmoCor device (r = 0.90; p < 0.001). The best correlation for pulse wave velocity was observed for BAT41-2 and SphigmoCor pair and BAT41-2 and Complior pair. Conclusions. In addition to accuracy appropriated for foreign devices this domestic device has a number of advantages that will help to facilitate the work of practitioners for the diagnosis, risk stratification and more correct and proper choice of antihypertensive drugs.
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