Clinical

Vascular Flow Technologies are delighted to announce the publication of the following paper:

‘Spiral Laminar Flow Prosthetic Bypass Graft: Medium-Term Results From a First-In-Man Structured Registry Study’

The paper was published in the November 2012 issue of the prestigious Annals of Vascular Surgery. We have summarised the findings of the paper below and you can download your own copy by clicking here.

Background

  • This paper describes a “first-in-man” study by Stonebridge, Vermassen, Dick,  Belch, and Houston on patients with peripheral arterial disease needing an above-the-knee or below-the-knee bypass graft
  • Lead author, Professor PA Stonebridge, first published his observations on Spiral Laminar Flow in The Lancet in 1991, with CM Brophy.

They proposed that spiral flow patterns might more accurately represent blood flow in arteries than current models of laminar flow and hypothesized that this flow pattern could exert a beneficial effect on the mechanisms of endothelial damage/repair

  • What are the features of spiral laminar flow that they highlighted?
    • Laminar stability
    • Reduced laterally directed forces
    • Reduced near-wall turbulence
    • Suppresses acute thrombus formation with no increase in platelet activation
    • Enhances oxygen flux to the arterial wall
    • Reduces luminal surface low-density lipoproteins concentration
    • Dampens wall stress temporal gradients
    • Lowers oscillatory shear stress index

The Study

  • The Spiral Flow™ Graft is a straight conduit internally engineered to produce outflow conditions identical to those seen in normal healthy arteries.
  • The graft was implanted into 40 patients with peripheral arterial disease requiring an above-the-knee or a below-the-knee bypass graft. The patients were recruited in 10 centres in the Netherlands and Belgium
  • Patients’ follow-up was asked for at 6 weeks and at 3, 6, 9, 12, 18, 24, and finally 30 months. Follow-up assessment included clinical assessment and colour Doppler assessment

The Results

  • The 12, 24, and 30 month primary patency rates were 86%, 81%, and 81% for above-the-knee bypasses and 73%, 57%, and 57% for below-the-knee bypasses, respectively. In the case of secondary patency rates numbers were the same for above-the-knee, and were 86%, 64%, and 64%, respectively, for below the-knee bypasses.

Key finding

  • This paper clearly demonstrates the potential for Spiral Laminar Grafts to be as good as, or better than, any known prosthetic graft technology, including Heparin bonded grafts

Why is this study important?

  • Peripheral arterial disease affects up to 20% of people over the age of 70. Patients are at high risk for cardiovascular events in the future, especially those needing bypass surgery. Improvements in bypass surgery techniques and devices are therefore very significant for this patient group. A large number of people could benefit.
  • This is a “First-in-man” study. These studies are very important. They are the bridge between clinical and non-clinical development and are designed for the safety of patients first and foremost.
  • This study demonstrates the validity of the concept of Spiral Laminar FlowTM. It shows patient outcomes  equivalent to, or exceeding,  any other prosthetic grafts, including Heparin bonded  grafts
  • The Annals of Vascular Surgery provides solid, peer reviewed coverage of clinical and experimental work in vascular surgery and is the official journal of six vascular surgery societies in the US and internationally.

Please call or e-mail if you have any questions about this paper and its findings or wish to talk to us about our Spiral FlowTM products.

Call: +44 (0) 1382 598 532

E-mail: info@vascular-flow.com