Implant in legs can offer an alternative to drugs

By Roger Dobson and Sara Malm For The Mail On Sunday

A wire ‘paper clip’ implant could offer an alternative to drugs for patients with high blood pressure that has proved difficult to treat.

The device is placed in the upper thigh, in order to create a channel between the main artery and a vein.

It results in some of the blood flow in the leg being diverted back up into the body and heart and, astonishingly, the effect is to lower blood pressure throughout the body.

This experimental procedure has proven effective in reducing high blood pressure in patients who are not responding to the medication.

The results of the first international trial, which included a team at Eastbourne General Hospital in East Sussex, were published in The Lancet in 2015.

The trial showed that patients responded well to the treatment, with some able to reduce their medication. There is anecdotal evidence of some sufferers coming off medication completely.

Leading vascular surgeon John Scurr welcomed the development as ‘exciting’ but urged caution, saying: ‘These are promising early-stage results, however there are genuine concerns and it is important that patients realise this is still very much a trial.

‘I’m also concerned that the effect of the implant could make the blood pressure drop quickly, and put a strain on the heart.’

Complications after surgery include problems with narrowed veins, requiring a further procedure, which occurred in a third of cases.

Blood pressure is measured in two ways: systolic pressure – the pressure when the heart beats and pushes blood out into the arteries – and diastolic pressure – the pressure when the heart relaxes between beats.

The ideal reading is no higher than 120/80 and high blood pressure, or hypertension, is diagnosed when levels of 140/90 or above are consistently seen.

The condition affects one in three adults in the UK and increases the risk of heart attack and stroke.

A range of drugs is used to treat hypertension, including beta blockers, calcium channel blockers and diuretics.

But one in 15 people with high blood pressure suffer from drugs-resistant hypertension.

Blood pressure is measured in arteries, the vessels that distribute blood pumped out from the heart.

Veins, which are not as tough as arteries and are not pressurised, take it back to the heart.

The Rox Coupler device, which is currently available only at selected UK hospitals, is a thin nickel titanium wire the size of a paperclip.

It is designed to divert some of the blood from the iliac artery into an adjacent vein, in order to lower blood pressure without significantly reducing blood flow into the limb.

During the implantation procedure, the doctor inserts two catheters through a needle puncture in the upper thigh, one for the vein and one for the artery and creates a hole between the femoral artery and the vein next to it, in which the Rox Coupler is placed.

The stent keeps the small hole, around 4mm, open between the artery and the vein.

The results of the first international trial, which included a team at Eastbourne General Hospital (pictured) in East Sussex, were published in The Lancet in 2015

Jane Smith, 52, from Eastbourne, had the stent implanted by Eastbourne Hospital cardiologist Dr Neil Sulke six months ago. She had been diagnosed with hypertension five years earlier.

Jane said: ‘My blood pressure came tumbling down instantly and I have already stopped taking beta blockers. I also have diabetes, and reducing the blood pressure has lowered my risk of cardiovascular problems.

‘I am absolutely delighted.’

Dr Sulke said: ‘Implanting this device is safe and blood pressure reduction in instantaneous.

‘It could be a very important new treatment option for resistant hypertension patients.’

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