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Investigating device supporting reduction of treatment-resistant hypertension

Overall summary

Hypertension is a leading health risk factor globally, and high and uncontrolled blood pressure is strongly associated with an increased risk of myocardial infarction, stroke, heart and kidney failure, as well as other cardiovascular diseases and organ damage. Hypertension affects over 1 billion people worldwide and is directly responsible for more than 10 million deaths, leading to it being declared a public health crisis by the World Health Organisation (WHO).

Health Innovation Oxford and Thames Valley (formerly the Oxford AHSN) is working along with Afferent Medical Solutions who have developed AffeX, a handheld, battery- operated, portable device which generates electrical stimulation through auricular innervation for use in the management and reduction of treatment-resistant hypertension.

The Oxford HIN team conducted a feasibility study, speaking to key stakeholders along the care pathway to determine the potential clinical utility, place in the clinical pathway, user requirements and perceived usefulness of the device.

What is the challenge?

Hypertension, or elevated blood pressure, is a serious medical condition that significantly increases the risk of heart, brain, kidney and other diseases. Reducing blood pressure can in turn reduce a patient’s chance of stroke by 40%. As many as 38.8% of stokes result from blood pressure which is being treated but is uncontrolled. This is a huge burden on the NHS with strokes costing the UK economy £2.3 billion per year.

While there is a wide array of pharmacological treatments for high blood pressure, a strong proportion of patients who suffer from high blood pressure do not respond to treatment and are classed as having resistant hypertension. Patients who usually fail to respond to optimal doses of three or more medicines and retain a blood pressure of above or equal to 140/90 mmHg are usually classed as having resistant hypertension.

What did we do?

The Oxford AHSN performed an initial literature search to explore the evidence base surrounding treatment resistant hypertension to identify the current care pathway in the NHS.

The Oxford AHSN carried out a Lean Assessment Process, interviewing stakeholders across primary, secondary and tertiary care settings to obtain the information required to understand the benefits, clinical utility, acceptance, where it would be placed in the clinical pathway and potential barriers to adoption of the AffeX device.

The key objectives of this study were to assess the potential impact of the device in the clinical pathway setting to enable Afferent to further develop the product in line with NHS needs and start to investigate the evidence that would be required for a future business case once the product was ready for market.

This project was funded by the National Institute for Health and Care Research.

What has been achieved?

The Oxford AHSN feasibility study demonstrated that a non-invasive and non-pharmacological approach to treating resistant hypertension was most welcome given that this is a sub-group of patients who have not achieved blood pressure control with medication.

The evaluation suggested that introducing AffeX into the care pathway has the potential to reduce the amount of medication taken by patients with resistant hypertension. This in turn  reduces the impact of side effects and benefiting drug intolerant patients . If people with drug-resistant hypertension achieve blood pressure control, this could result in a reduction of patients having strokes,  heart attacks and renal failures.

What people said

“The study has been extremely useful to Afferent providing first-hand feedback on issues that need to be considered before AffeX can be adopted by the NHS.  It has also provided user input into Afferent’s device development programme – addressing a requirement set-out in the Medical Device Regulations.”

Dr Everard Mascarenhas,  CEO, Afferent Medical Solutions

What next?

Further evidence and data are required for clinical validation. These will be obtained by carrying out a clinical trial. Once the product has gained all of its required regulatory approvals, a real-world evaluation needs to be conducted to support further adoption.

Contact Lead Health Economist & Methodologist