Experts claim a new medical device which resembles a twisted paper clip could potentially save the lives of those at greatest risk from stroke, heart attacks and heart failure.
Inserted into the groin, the device controls and lowers the blood pressure of even the most hard-to-treat patients. The coupler creates a chamber between the artery and the vein in the upper thigh which appears to help lower resistance and bring blood pressure down.
According to a report published in the medical journal, The Lancet, the device was effective in two thirds of cases during a study of 83 patients.
It found that those who received the device experienced an immediate reduction in blood pressure; however, one third also developed swelling in their leg which needed treatment.
In the UK, high blood pressure affects one in three adults, creating strain on the vessels carrying blood around the body, and causing them to become clogged up or to weaken. Ultimately, this can lead to significant damage to the heart or brain and can result in death.
One in 20 of those affected suffer from resistant hypertension, which does not respond to medication.
The study, led by researchers Queen Mary University of London and funded by the manufacturers, ROX Medical in California, tested the device on 42 patients with high blood pressure which had not responded to at least three types of drug intervention.
They compared the effects with 35 patients who were given the standard treatment for uncontrolled high blood pressure.
The study found “significant reductions in blood pressure” in the group fitted with the device six months after it was implanted, with fewer hypertensive complications and fewer hospital admissions for high blood pressure emergencies. This cohort of patients were also able to reduce their medication.
However, the device did have some side-effects. In almost a third of patients (29%) swelling developed in the leg in which the coupler was inserted, resulting in the need for another procedure to insert a stent in the vein.
Lead author Dr Melvin Lobo, from Queen Mary University of London, acknowledged there was more to learn about the device:
“We need more research to explore the long-term effects of the coupler, better understand its safety and understand more about how it works within the body.
“We must find better means of treating high blood pressure as drugs do not work for everyone and the coupler is a big step forward in our search for alternative treatment.”
Prof Tom MacDonald, president of the British Hypertension Society, and professor of clinical pharmacology at the University of Dundee, said the device could be “a fantastic thing for patients”.
“It’s another potentially great advance in the treatment of hypertension. It’s not without its problems, but the beauty of it is you can reverse it, and it can be given to people on top of hypertension medication.
“We now need more rigorously controlled studies and a definitive trial before it can be funded for the NHS.”
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