Original Title: Sistema de monitorización cardiovascular mediante fotopletismografía

Authors' objectives: To analyse the efficacy, effectiveness and safety of the Biobeat devices as a cardiovascular monitoring system in patients with cardiovascular disease.

Authors' results and conclusions: For summarising the evidence on the safety and efficacy of the Biobeat device, 19 studies published between 2020 and 2024 were included. Fifteen of the studies (79%) were conducted in Israel, and the overall target population was composed of healthy individuals (21%), as well as patients with hypertension (11%), with coronavirus disease 2019 or recently vaccinated against the Sars-Cov-2 virus (26%) or at risk of clinical deterioration (16%) (postoperative and hospitalised patients, as well as those admitted to an intensive care unit). In all the registries, the intervention consisted of using one of the Biobeat devices, either the wrist-worn watch or the chest patch, for cardiovascular monitoring in hospital or at home, compared to standard monitoring approaches, such as using a sphygmomanometer, an arterial line, a cardiac monitor, or cardiac output from pulse contour analysis or the National Early Warning Score (NEWS) used clinically. Various health outcomes were assessed: precision, accuracy, safety, and specificity of 13 health parameters, adverse effects using the NEWS score, level of satisfaction using the user satisfaction survey, mortality, or clinical deterioration using the multi-parameter real-time warning score (MPRT-WS). In the general population, several studies have found that the Biobeat devices provide similar measurements to a sphygmomanometer. The Biobeat measurements have also been found to be more strongly correlated with other parameters, such as CO2 or cardiac output, than measurements from the PiCCO® device. In postoperative heart surgery patients, the evidence suggests a high correlation between blood pressure readings from the Biobeat devices and those from arterial pressure monitoring. On the other hand, a recent study measuring blood pressure using the Biobeat device during haemodialysis sessions in patients with chronic liver disease reported a marked bias in systolic and diastolic blood pressure measurements, indicating that Biobeat data may not be valid in all situations.In recent years, there has been a rapid increase in digital tools that use mobile devices for health-related purposes. Photoplethysmography-based cuffless smart devices could be a valuable tool for managing certain chronic conditions, as they are also widely acceptable to patients. Nonetheless, comparison studies highlight variability in the accuracy of their measurements of various health parameters, indicating the need for more validation studies. Further, for these devices to be adopted in clinical practice, it should be demonstrated that their use has a clinical impact on patients, facilitating access to health care, improving efficiency and safeguarding the privacy of the data recorded. Studies demonstrating this type of clinical impact would justify the use of these devices in standard clinical practice, since it would help identify in which cases they should be used. Most of the studies included were observational in nature (67%). In addition, the majority were carried out in Israel, hindering the generalisation of results to other populations. Cost implications are barely touched on, and hence, the economic impact of adopting this technology in the Spanish National Health System compared to traditional monitoring systems is unknown. Further, there is a lack of longterm safety data, which is essential to ensure patient safety during prolonged periods of use.

Authors' methods: A review of the evidence was conducted to identify studies on the Biobeat devices. In March 2024, searches were conducted in each database, using the specific term related to the technology (Biobeat) as a search term.

Project Status: Completed

Year Published: 2025

URL for published report: https://www.euskadi.eus/contenidos/informacion/osteba_publicacion/eu_def/adjuntos/E-25-08-Sistema_de_monitorizacion_cardiovascular.pdf

English language abstract: An English language summary is available

Publication Type: Rapid Review

Country: Spain

Organisation Name: Basque Office for Health Technology Assessment

Contact Address: C/ Donostia – San Sebastián, 1 (Edificio Lakua II, 4ª planta) 01010 Vitoria - Gasteiz

Contact Name: Lorea Galnares-Cordero

Contact Email: lgalnares@bioef.eus

Copyright: <p>Osteba (Basque Office for Health Technology Assessment) Health Department of the Basque Government</p>