Cuffless blood pressure measuring devices: review and statement by the European Society of Hypertension Working Group on Blood Pressure Monitoring and Cardiovascular Variability

Abstract

Background:Many cuffless blood pressure (BP) measuring devices are currently on the market claiming that they provide accurate BP measurements. These technologies have considerable potential to improve the awareness, treatment, and management of hypertension. However, recent guidelines by the European Society of Hypertension do not recommend cuffless devices for the diagnosis and management of hypertension.Objective:This statement by the European Society of Hypertension Working Group on BP Monitoring and Cardiovascular Variability presents the types of cuffless BP technologies, issues in their validation, and recommendations for clinical practice.Statements:Cuffless BP monitors constitute a wide and heterogeneous group of novel technologies and devices with different intended uses. Cuffless BP devices have specific accuracy issues, which render the established validation protocols for cuff BP devices inadequate for their validation. In 2014, the Institute of Electrical and Electronics Engineers published a standard for the validation of cuffless BP devices, and the International Organization for Standardization is currently developing another standard. The validation of cuffless devices should address issues related to the need of individual cuff calibration, the stability of measurements post calibration, the ability to track BP changes, and the implementation of machine learning technology. Clinical field investigations may also be considered and issues regarding the clinical implementation of cuffless BP readings should be investigated.Conclusion:Cuffless BP devices have considerable potential for changing the diagnosis and management of hypertension. However, fundamental questions regarding their accuracy, performance, and implementation need to be carefully addressed before they can be recommended for clinical use.

Cuffless blood pressure devices: the gap between patient acceptability and need for validation

“…However, cuffless BP device accuracy is yet to be determined, with appropriate cuffless device validation protocols still under development. Given the high proportion of people with undiagnosed hypertension in the community, there is need to balance high participant acceptability and need for increased BP awareness in the community with fundamental concerns about accuracy [1]. Although the role of cuffless devices is yet to be established in clinical practice, it is clear that patients express overwhelming preference for cuffless technology compared to classic cuff-based methods.…”

“…In the recent statement by the European Society of Hypertension on ‘Cuffless blood pressure measuring devices’, Stergiou et al [1] conclude that fundamental questions remain regarding the accuracy and performance of wearable cuffless blood pressure (BP) monitoring technology. These devices have emerged as a novel approach to continuously measure BP, rather than single snapshot clinic measures that are subject to substantial variability.…”

“…Cuffless BP devices provide automated out-of-office BP readings without any cuff disturbance or user awareness. Given the accuracy of cuffless devices remains to be established, they have not been recommended for clinical use [1,3].…”

Innovations to address the burden of hypertension: Assessing accuracy of a smartphone application-based blood pressure estimation algorithm in Bangladesh, South Africa and Tanzania among general and pregnant populations

“…The lack of independent evaluations and insu cient rigor in the design of accuracy assessments is also a commonly cited criticism, with rami cations for regulatory oversight and trust by end-users. [24][25][26][27] Therefore, this study was developed in accordance with ISO requirements, which entailed a rigorous threshold for inter-nurse agreement to establish the reference value and ensuring a speci c distribution of participants across sex, age, and BP parameters. The blinding of all stakeholders, including the study team and software developers, to the device BP values, lends to the credibility of the ndings.…”

State-of-the-Art Deep Learning Methods on Electrocardiogram Data: Systematic Review

“…Recent attention in the medical field to the concept of BP variability [325] rather than clinical spot checks highlights the need for ambulatory BP monitors that are both ergonomic for the patient to increase compliance and comfort, as well as reliable and well validated. A common pitfall in the use of calibrated techniques is that subsequent test data points do not differ significantly from the calibration value and thus yield small errors in prediction, whereas the data are presented as an aggregate pooled correlation plot or Bland-Altman plot with a correlation value that simply reflects the range of BPs across the population rather than patient-specific BP variation [326,327]. In our review of articles using DL for BP prediction, we did not encounter significant attempts to address the issue of BP variability in training data; in fact, many publications explicitly removed data points with hypertensive values or large pulse pressures from their data sets as "artifacts" [93][94][95][96]98].…”