EUnetHTA final report for 24-hour blood pressure measurement device Mobil-O- Graph® published

On July 03, 2020, the network of European HTA agencies, EUnetHTA, published the final report for the Rapid Relative Effectiveness Assessment OTCA24 ‘The 24-hour blood pressure measurement device Mobil-O- Graph® with the built-in algorithm ARCSolver® to measure arterial stiffness for the optimization of hypertension treatment.”

Mobil-O-Graph®(I.E.M, Stolberg, Germany) is a peripheral blood pressure measuring. It can be coupled with ARCSolver® (Austrian Institute of Technology) algorithm that uses pulse wave analysis to calculate aortic systolic blood pressure (aSBP) and Augmentation Index (AIx) in combination with the oscillometric blood pressure measurement, and therefore arterial stiffness. Arterial stiffness parameters that can also be obtained using other devices help to assess hypertension more precisely and to define the cardiovascular risk.

The study objective was to find out whether the pulse wave analysis device Mobil-O-Graph® with the ARCSolver® algorithm in the out-patient setting is more effective and/or safer in patients at risk of cardiovascular events or in hypertension diagnosing and monitoring, compared to current standard practice.

A systematic literature search was conducted using the Embase.com platform, including Medline and Embase databases. Additionally, the Center for Research and Dissemination databases and clinicaltrials.gov were searched.

A total of 14 studies were found that describe the efficacy of Mobil-O-Graph® with ARCSolver® for primary and secondary prevention of cardiovascular risk as well as for diagnosis and monitoring of hypertension. No evidence was found on safety. No ongoing, non-published, relevant clinical trials were found.

ARCSolver®, as part of Mobil-O-Graph® is currently being reimbursed in Austria. No feedback regarding reimbursement was received from EUnetHTA partners.

It is not clear whether Mobil-O-Graph® with ARCSolver® is equal, less, or more effective than comparators in relation to patient outcome and therapeutic or diagnostic efficacy. The current literature on Mobil-O-Graph® with ARCSolver® focuses on technical efficacy and characteristics compared to other devices that measure arterial stiffness. There is moderate-quality evidence that Mobil-O-Graph® technical efficiency is equivalent to other devices, using an algorithm or carotid-femoral pulse wave velocity. There is a lack of evidence whether or not Mobil-O-Graph® with ARCSolver® is more effective and safer and lead patients to better health care services and treatment to hypertension control or cardiovascular events. Further studies need to concentrate on diagnostic accuracy compared to other cardiovascular risk assessment tools and to common blood pressure measurement in hypertension.

The full details in English can be found here.

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