Spiral Laminar Flow grafts show encouraging midterm patency results

Presented at Veith Symposium November 2013, New York Prof Frank Vermassen, University of Ghent Hospital, Belgium

Introduction

Advantages of spiral flow laminar flow stability

–Spiral flow preserves laminar flow through a stenosis better reducing turbulent kinetic energy

Why a spiral flow graft?

Hypothesis:

  • Intimal hyperplasia at the distal anastomosis is a frequent reason for graft failure.
  • Development of intimal hyperplasia is a reaction of the blood vessel to abnormal flow patterns
  • By inducing normal, spiral flow the development of intimal hyperplasia can be prevented

Patients and Methods

Phase 1 Study using 6 mm ringed ePTFE SLF graft (Vascular Flow Technologies Ltd). Spiral inducer at distal end to induce spiral flow at distal anastomosis.

39 Patients from 8 centres in Benelux

Study inclusion 02/06- 10/07; 5 year follow-up till 07/2013

  • 73 % male, 27% female
  • 59% above knee, 41% below knee
  • 57% CLI, 43% Claudication
  • 13% diabetics
  • 43% current smokers

Results

In 10 random patients the presence of spiral laminar flow at 3-6 months was assessed. All showed the distinctive flow pattern.

The five year cumulative patency rates were 62% above knee and 52% below knee.

Conclusions

  • The phase 1 study showed that implantation of the Spiral Flow graft is feasible and safe.
  • The Spiral Flow graft induces Spiral Laminar Flow at the distal anastomosis
  • The 5 year results are encouraging compared to published literature
  • Other products incorporating Spiral Laminar Flow technology are in development