Advice

Technology overview

Technology overview

This briefing describes the regulated use of the technology for the indication specified, in the setting described, and with any other specific equipment referred to. It is the responsibility of healthcare professionals to check the regulatory status of any intended use of the technology in other indications and settings.

About the technology

CE marking

WL Gore & Associates first received a Class III CE mark for the Gore PROPATEN heparin‑coated vascular graft ('PROPATEN graft') in May 1999. The current certificate is effective from 16 November 2014, and is valid until 15 November 2017.

The associated Declaration of Conformity is dated 10 March 2011, and the Design Examination Certificate is effective from 3 May 2014 (valid until 2 May 2019).

Description

The PROPATEN graft is an artificial vascular graft made from ePTFE and coated on the inner (luminal) surface with low molecular weight heparin (CBAS 2‑heparin). The graft incorporates stretch technology which is intended to improve anastomotic compatibility, length forgiveness and kink resistance.

PROPATEN grafts are available in a range of configurations and sizes:

  • Standard‑walled or thin‑walled – Thin‑walled PROPATEN grafts are approximately 40% thinner than standard walled grafts and may be used because of their similarity to the host vessel.

  • Fixed rings, removable rings, or without rings – Integrated rings provide low‑profile radial support. Removable rings are attached to thin film so that they can be removed without damaging the graft.

  • Internal diameters ranging from 5–8 mm or tapered (from 6–4 mm or 7–4 mm).

  • Ringed section lengths of 5, 30, 40, 60 or 70 cm.

  • Standard lengths of 10, 20, 40, 45, 50, 60, 70, 80 or 90 cm.

The grafts can be cut to the appropriate length at an anastomotic angle to suit the procedure being performed.

Setting and intended use

The PROPATEN vascular grafts are intended for use as vascular prostheses for replacing or bypassing diseased vessels in patients with occlusive diseases. The scope of this briefing is the PROPATEN graft for treating PAD.

The grafts are designed to be used in the secondary care inpatient setting. They are intended only to be used by suitably qualified clinicians who are experienced in peripheral vascular bypass procedures. Their use is contraindicated in patients with known sensitivity to heparin, including patients who have had a previous (or existing) incident of HIT type 2.

Current NHS options

Lifestyle changes for people with PAD are described in the NICE guideline on prevention of cardiovascular disease and drug interventions are described in the NICE technology appraisal guidance on cilostazol, naftidrofuryl oxalate, pentoxifylline and inositol nicotinate for the treatment of intermittent claudication in people with peripheral arterial disease.

Surgical procedures, including angioplasty and bypass grafts, are additional treatment options for PAD. These aim to restore the flow of blood through the arteries of the legs, known as revascularisation. Angioplasty is a method where the narrowed area of the artery is widened by a small balloon which is inflated inside the vessel. Sometimes a 'stent' or small mesh tube may be left in place to keep the artery open.

Bypass surgery may be offered to people with severe lifestyle‑limiting intermittent claudication when angioplasty has been unsuccessful or is unsuitable, and where imaging has confirmed that it is appropriate. It may also be used in people with critical limb ischaemia needing revascularisation. NICE's guideline on lower limb peripheral arterial disease recommends that an autologous vein should be used whenever possible. A range of synthetic grafts is currently available to the NHS and current practice varies in the choice of graft.

NICE has also issued interventional procedures guidance on percutaneous laser atherectomy as an adjunct to balloon angioplasty (with or without stenting) for peripheral arterial disease.

NICE is aware of the following CE‑marked devices that appear to fulfil a similar function to the PROPATEN graft:

  • Hybrid vascular graft (Gore), featuring a nitinol reinforced section and heparin bonding (Carmeda BioActive Surface)

  • Flowline BIPORE HEPARIN ePTFE vascular graft (Jotec)

  • FUSION BIOLINE vascular grafts (Maquet), made of ePTFE and polyethylene terephalate (PET) with a heparin coating

  • INTERGARD heparin vascular graft (Atrium), made of PET

  • Vascutek Gelsoft Plus (Terumo) gelatin‑sealed knitted polyester vascular graft, with temporary heparin activity of up to 4 days.

Costs and use of the technology

The manufacturer declined to provide the cost of a PROPATEN graft. Based on similar products, and expert advice, the likely cost of a PROPATEN graft is estimated to be between £600 and £1000 excluding VAT. For similar products, the cost varies depending on the size, shape and length.

According to the manufacturer, no additional or special training, equipment or support is needed in order to use the device. Optional educational programmes are available.

The lifespan of the technology is dependent on the functionality of the graft. Grafts with higher patency rates are less likely to need repeated interventional procedures and will therefore reduce overall costs to the NHS.

In England in 2013–14, 4285 bypass procedures of the femoral artery were done, including 330 emergency procedures. Of these, 2542 used autologous vein grafts and 810 used prosthetic grafts (HSCIC 2015).

The payment by results tariff for 2013–14 (Department of Health 2013) has been provided below for information. The NHS tariffs for outpatient attendance relating to consultant‑led vascular surgery services (service code 107) are:

  • first attendance: £156 (WF01B/WF02B)

  • follow‑up attendance: £93 (WF01A/WF02A).

The NHS costs for combined day case or ordinary elective spells (Payment by Results 2013–14) are:

  • bypasses to tibial arteries: £8266 (HRG code, QZ03Z)

  • amputations without complications and co‑morbidities: £7625 (HRG code, QZ11B)

  • amputations with complications and co‑morbidities: £14,724 (HRG code, QZ11A).

The costing report for the NICE guideline on lower limb peripheral arterial disease suggests that amputation may be offered when revascularisation options such as bypass cannot control critical limb ischaemia. It estimates that in addition to the procedure itself, the cost of care to the NHS is approximately £20,000 per patient in the year following an amputation.

Likely place in therapy

The PROPATEN graft could be used for patients with PAD needing a synthetic bypass graft. Use of the device is not expected to change the current clinical pathway.

Specialist commentator comments

One specialist commentator noted that there was a wide range of study designs and outcomes. No individual study was thought to be sufficiently powerful to be considered definitive. Two specialist commentators emphasised the importance of differentiating between results for above‑ and below‑knee femoropopliteal bypasses. It was suggested that the device should be evaluated in the context of historical data relating to other types of heparin‑bonded graft.

Three specialist commentators concluded that the overall performance of the PROPATEN graft was not as good as ASV grafts, but in most clinical scenarios it provided an outcome that was similar to that of standard (that is, non‑heparin‑bonded) ePTFE grafts. One specialist commentator suggested that there may be a higher long‑term risk of amputation with PTFE compared with heparin‑bonded PET, but that this has not yet been established.

One specialist commentator observed that in patients with an unsuitable or absent vein because of previous peripheral vascular surgery, the PROPATEN graft appears to be inferior to a Distaflo with vein patch in tibial bypasses. One specialist commentator advised that use of any prosthetic graft to bypass the arteries of the calf may rarely, if ever, be justified.

One specialist commentator suggested that the use of heparin‑bonded grafts might reduce the number of subsequent revisions needed, which could ultimately reduce pressure on the healthcare system. One specialist commentator noted that information about the relative costs of the PROPATEN grafts and other comparator grafts would help to inform decision‑making.

Equality considerations

NICE is committed to promoting equality and eliminating unlawful discrimination. In producing guidance, NICE aims to comply fully with all legal obligations to:

  • promote race and disability equality and equality of opportunity between men and women

  • eliminate unlawful discrimination on grounds of race, disability, age, sex, gender reassignment, pregnancy and maternity (including women post‑delivery), sexual orientation, and religion or belief (these are protected characteristics under the Equality Act 2010).

PAD is more common in people over the age of 60 years and affects more men than women. people with diabetes have an increased risk of developing PAD, and diabetes is recognised as a long‑term health condition that may cause disability.

The heparin that is used in the PROPATEN graft is of porcine origin. A number of religious groups are prohibited from contact with the flesh of pigs, and some patients may be opposed to the use of a heparin‑coated product.

Age, sex, disability and religion (or belief) are protected characteristics under the Equality Act 2010.