Advice

Summary

Summary

The Spiral Flow peripheral vascular (PV) graft is used for peripheral arterial disease to bypass or reconstruct damaged blood vessels. Of 5 studies (2 published and 3 abstracts), 1 of the published studies compared the Spiral Flow graft to other artificial grafts and reported similar or worse primary patency. The second comparative study, available as an abstract only, reported better patency rates for the Spiral Flow graft than for PTFE grafts. The other studies investigated primary and secondary patency rates for the Spiral Flow graft. The cost of a Spiral Flow PV graft is £952 to £1520, excluding VAT, depending on size.

Likely place in therapy

  • The Spiral Flow peripheral vascular (PV) graft is a synthetic graft used to treat peripheral arterial disease.

  • It would be used as an alternative to current peripheral vascular grafts to maintain effective blood flow to the lower limbs. Current practice varies in the choice of artificial grafts, which are used only when an autologous graft is unavailable.

Effectiveness and safety

  • The currently available evidence for the clinical effectiveness of the Spiral Flow PV graft is limited in both quantity and quality.

  • In the only fully‑published comparative study, patency rates for the Spiral Flow PV graft were the same or worse compared with another expanded polytetrafluoroethylene graft.

  • In 4 other studies, of which 3 were available only as abstracts, primary patency rates varied from 57% to 93%.

  • The exact number of patients included in all 5 studies is not clearly reported, but it is estimated to be around 230. Three studies (1 fully‑published) reported adverse effects, including 4 deaths. Two deaths were unrelated to the graft and 2 were in patients with serious comorbidities.

Technical factors

  • The Spiral Flow PV graft incorporates a helical interior that is designed to promote a natural spiral pattern of blood flow, which is claimed to reduce the risk of neointimal hyperplasia that can arise from unnatural turbulence in the blood flow.

  • The Spiral Flow PV graft is available in a range of lengths and diameters.

  • The Spiral Flow PV graft would be used in secondary care by suitably qualified clinicians, experienced in carrying out peripheral vascular bypass graft procedures.

Cost and resource use

  • The Spiral Flow PV graft costs between £952 and £1520, depending on size.

  • There was no published evidence on cost and resource use for the Spiral Flow PV graft.

  • Any graft reducing the need for repeated interventional procedures could reduce long‑term treatment costs.