UK surgeons 'slow' to adopt new device that could prevent amputations

Manufacturer claims UK medics are putting initial cost before long-term impact

The Zilver PTX drug eluting stent has been found to improve outcomes for patients with PAD, but take up in the UK is still slow, according to manufacturers

UK surgeons and radiologists have been slow to embrace a new technology that could significantly reduce the number of amputations performed as a result of complications caused by peripheral artery disease (PAD).

The Zilver PTX Drug-Eluting Stent from Cook Medical was introduced commercially to European physicians in 2009 and is the first device of its kind developed to treat PAD in the superficial femoral artery.

Clinical trials around the world have found it to be significantly more effective at preventing revascularisation when compared to angioplasty and bare metal stenting.

But, despite the growing evidence that it can help patients stay healthier for longer and prevent a large number of amputations, the NHS is yet to embrace the technology.

Technologies like the Zilver PTX offer a significant chance to minimise serious surgical interventions and improve patient outcomes, but the UK adoption of these proven technologies is extremely slow with regional variation

Speaking exclusively to BBH, Andy Förster, EMEA manager at Cook Medical’s Peripheral Intervention Clinical Division said the health service needed to think more long term about future treatment pathways and opt for the best overall treatment, rather than the cheapest option.

He spoke out after the National Institute for Clinical Excellence (NICE) published guidelines on how clinicians should diagnose and manage PAD, which is becoming an increasingly common health problem as the population ages and obesity rates soar.

The guidance comes hot on the heels of the revelation by Diabetes UK that the cost to the NHS of PAD-related amputations is in excess of £252m a year.

Förster said: “Technologies like the Zilver PTX offer a significant chance to minimise serious surgical interventions and improve patient outcomes, but the UK adoption of these proven technologies is extremely slow with regional variation.

“I have no doubt the surgical expertise is there, but I think that for the NHS it is much more likely to be a financial decision. What the NHS does not seem to do is look at its investment decisions on a mid to long-term basis.

“Instead there should be a more holistic view adopted by commissioning groups to take into account the development of multiple disciplinary teams and savings achieved through fewer re-admissions. For example, since gaining reimbursement in France, it’s calculated that Zilver PTX will save authorities, between €8m and €30m over a five year period, depending on the number of procedures conducted.”

The amputation rate in this country is very high compared to our European neighbours and we have now got to consider the most effective treatments that offer the best value for money in terms of helping patients in the long term

And he warned that the ageing population would mean the likelihood of complications from PAD increasing and more patients being put at risk of amputations.

PAD is caused by atherosclerosis, the build-up of fatty deposits within the lining of the arteries. Over time these arteries may narrow, resulting in a reduction in blood flow known as critical limb ischaemia, which in severe cases can lead to amputation of the limb.

NHS Information Centre figures show that in 2009-2010, there were 15,812 lower limb amputation procedures in England alone, many of which were linked to vascular disease.

The prevalence of PAD increases with age and at least one in 20 people over the age of 55 in the UK have some degree of the disease. These people have an increased mortality risk and are six to seven times more likely to suffer from heart disease or stroke compared with healthy people.

Traditionally, surgical interventions have included angioplasty, whereby a small balloon is inserted into the artery then inflated in the narrowed section; and stenting, where a small mesh tube is guided into the artery and expanded to allow for normal blood flow.

Unlike standard stents, the Zilver PTX stent is coated with Paclitaxel to prevent renarrowing of the artery and was shown to outperform angioplasty and bare metal stents in a randomised clinical trial.

As a result of this evidence, the technology has been named as a class three product by The Innovative Technology Adoption Procurement Programme (iTAPP), a scheme pioneered by the NHS to encourage the adoption of high-impact medical technologies that will improve patient outcomes while reducing the overall cost of care. Zilver PTX is also mentioned in The NHS Technology Adoption Centre’s Technology Briefing Packs .

Elsewhere in Europe, surgeons appear to be much more embracing of the technology, with more than 10,000 patients having undergone treatment across the continent, including in the UK.

Förster said: “The NHS has been waiting for the evidence and now the evidence is there in term of the impact of this technology. The amputation rate in this country is very high compared to our European neighbours and we have now got to consider the most effective treatments that offer the best value for money in terms of helping patients in the long term.”

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