A revolutionary paper clip sized implant can significantly lower blood pressure among patients with resistant hypertension, scientists have claimed.
The implant, called 'Coupler', is inserted between the artery and vein in the upper thigh, in a procedure lasting around 40 minutes under local anaesthetic.
Researchers from Queen Mary University of London led a randomised, blinded endpoint clinical trial with patients from multiple European Centres of Hypertension Excellence all of whom had resistant high blood pressure and had not responded to at least three types of drug treatment.
The team compared the effects of the Coupler versus usual medical treatment in 83 patients of whom 44 received the Coupler therapy. Patients who received the Coupler experienced a significant and durable reduction in blood pressure.
There was also a reduced number of hypertensive complications and hospital admissions for high blood pressure crises.
The Coupler, developed by ROX Medical in the US, also worked well among patients who had failed to respond to renal denervation (another new approach to treating high blood pressure), suggesting the Coupler targets different mechanisms of blood pressure control.
Patients who had not previously been treated with renal denervation experienced the same level or more of blood pressure reduction. In addition, unlike renal denervation, this new device-based treatment is fully reversible, immediate and pain-free.
"This is an entirely new and highly promising concept in high blood pressure treatment," said Dr Melvin Lobo, Lead Author and Principal Investigator of the study at Queen Mary University of London.
"Existing drugs focus on hormonal or neurological regulation of blood pressure, and newer treatments such as renal denervation are uniquely centred on the renal nervous system.
"The Coupler effectively targets the mechanical aspects of how blood circulation works - so it's a totally new approach to controlling blood pressure.
"The Coupler also highlights the importance of arterial stiffness as a major cause of resistant high blood pressure and it targets this issue both safely and successfully. Once the Coupler is placed, the results are also immediate, which again is unique to this treatment," Lobo said.
The study findings, published in The Lancet, show that blood pressure treatment with the ROX Coupler can give both patients and doctors an alternative option for treating high blood pressure in the future - particularly when standard therapies have failed.
Researchers said, the Coupler, like all therapies, did have a side effect. Around 29 per cent of patients who received the Coupler developed leg swelling which meant another short procedure was needed to deal with this (usually a stent in the vein).
