Several novel cuffless wearable devices and smartphone applications claiming that they can measure blood pressure (BP) are appearing on the market. These technologies are very attractive and promising, with increasing interest among health care professionals for their potential use. Moreover, they are becoming popular among patients with hypertension and healthy people. However, at the present time, there are serious issues about BP measurement accuracy of cuffless devices and the 2021 European Society of Hypertension Guidelines on BP measurement do not recommend them for clinical use. Cuffless devices have special validation issues, which have been recently recognized. It is important to note that the 2018 Universal Standard for the validation of automated BP measurement devices developed by the American Association for the Advancement of Medical Instrumentation, the European Society of Hypertension, and the International Organization for Standardization is inappropriate for the validation of cuffless devices. Unfortunately, there is an increasing number of publications presenting data on the accuracy of novel cuffless BP measurement devices, with inadequate methodology and potentially misleading conclusions. The objective of this review is to facilitate understanding of the capabilities and limitations of emerging cuffless BP measurement devices. First, the potential and the types of these devices are described. Then, the unique challenges in evaluating the BP measurement accuracy of cuffless devices are explained. Studies from the literature and computer simulations are employed to illustrate these challenges. Finally, proposals are given on how to evaluate cuffless devices including presenting and interpreting relevant study results.

High blood pressure (BP) is a major cardiovascular risk factor that is treatable, yet hypertension awareness and control rates are low. Ubiquitous BP monitoring technology could improve hypertension management, but existing devices require an inflatable cuff and are not compatible with such anytime, anywhere measurement of BP. We extended the oscillometric principle, which is used by most automatic cuff devices, to develop a cuff-less BP monitoring device using a smartphone. As the user presses her/his finger against the smartphone, the external pressure of the underlying artery is steadily increased while the phone measures the applied pressure and resulting variable-amplitude blood volume oscillations. A smartphone application provides visual feedback to guide the amount of pressure applied over time via the finger pressing and computes systolic and diastolic BP from the measurements. We prospectively tested the smartphone-based device for real-time BP monitoring in human subjects to evaluate usability (n = 30) and accuracy against a standard automatic cuff-based device (n = 32). We likewise tested a finger cuff device, which uses the volume-clamp method of BP detection. About 90% of the users learned the finger actuation required by the smartphone-based device after one or two practice trials. The device yielded bias and precision errors of 3.3 and 8.8 mmHg for systolic BP and −5.6 and 7.7 mmHg for diastolic BP over a 40 to 50 mmHg range of BP. These errors were comparable to the finger cuff device. Cuff-less and calibration-free monitoring of systolic and diastolic BP may be feasible via a smartphone.

We developed an iPhone X application to measure blood pressure (BP) via the “oscillometric finger pressing method”. The user presses her fingertip on both the front camera and screen to increase the external pressure of the underlying artery, while the application measures the resulting variable-amplitude blood volume oscillations via the camera and applied pressure via the strain gauge array under the screen. The application also visually guides the fingertip placement and actuation and then computes BP from the measurements just like many automatic cuff devices. We tested the application, along with a finger cuff device, against a standard cuff device. The application yielded bias and precision errors of −4.0 and 11.4 mmHg for systolic BP and −9.4 and 9.7 mmHg for diastolic BP (n = 18). These errors were near the finger cuff device errors. This proof-of-concept study surprisingly indicates that cuff-less and calibration-free BP monitoring may be feasible with many existing and forthcoming smartphones.

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