Abstract
Background: Antares is an algorithm for pulse wave analysis (PWA) by oscillometric blood pressure (BP) monitors in order to estimate central (aortic) blood pressure (cBP). Antares aims to enable brachial cuff-based BP monitors to be type II-devices, determining absolute cBP values independently of potential peripheral BP inaccuracies. The present study is an invasive validation of the Antares algorithm in the custo screen 400. Methods: We followed entirely the 2017 ARTERY protocol for validation of non-invasive cBP devices, the 2013 American National Standards Institute, Inc./Association for the Advancement of Medical Instrumentation/International Organization for Standardization (ANSI/AAMI/ISO) 81060-2 and 2018 AAMI/European Society of Hypertension (ESH)/ISO validation standard protocols. In total, 191 patients undergoing cardiac catheterization were included, of which 145 patients entered analysis. Invasive cBP recordings were compared to simultaneous non-invasive cBP estimations using the Antares algorithm, integrated into an oscillometric BP monitor. Results: Mean difference between invasive and non-invasively estimated systolic cBP was 0.71 mmHg with standard deviation of 5.95 mmHg, fulfilling highest validation criteria. Conclusion: Antares is the first algorithm for estimation of cBP that entirely fulfills the 2017 ARTERY and AAMI/ESH/ISO validation protocols. The Antares algorithm turns the custo screen 400 BP monitor into a type II-device. Integration of Antares into commercially available BP monitors could make it possible to measure PWA parameters in virtually every practice in future.
Highlights
Central blood pressure is not the same as peripheral blood pressure [1]
The study confirmed that the Antares algorithm turns the oscillometric custo screen 400 blood pressure monitor into a type II-device for non-invasive estimation of true central BP fulfilling entirely the 2017 ARTERY validation protocol (Table 4) as well as the 2013 ANSI/AAMI/International Organization for Standardization (ISO) 81060-2 and the 2018 AAMI/European Society of Hypertension (ESH)/ISO validation protocol including the criteria for high-accuracy devices
This validation study, which is comparing the invasively measured central BP with the non-invasive estimation using a regular oscillometric BP device, shows a level of agreement that faces the highest requirements as defined as the mean value of differences within five mmHg and standard deviation of less than 8 mmHg [7]
Summary
Central blood pressure (cBP) is not the same as peripheral blood pressure (pBP) [1]. Basically, in a young, healthy arterial system cBP is low and pBP much higher [1]. According to the current European Society of Hypertension/European Society of Cardiology (ESH/ESC) hypertension guidelines, measurement of cBP has practical consequences for the treatment of young patients with isolated systolic hypertension [6]. For these individuals, no medication is necessary if cBP is low. Antares is an algorithm for pulse wave analysis (PWA) by oscillometric blood pressure (BP) monitors in order to estimate central (aortic) blood pressure (cBP). Conclusion: Antares is the first algorithm for estimation of cBP that entirely fulfills the 2017 ARTERY and AAMI/ESH/ISO validation protocols. Integration of Antares into commercially available BP monitors could make it possible to measure PWA parameters in virtually every practice in future
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