Spiral Laminar Flow Prosthetic Bypass Graft: Bypass Graft: Medium-Term Results From a First-In-Man Structured Registry Study
A number of surgical strategies and graft enhancements have been trialled to improve the performance of prosthetic grafts. Neointimal hyperplasia may, in part, be a normal cellular response to an abnormal (turbulent) flow environment. This first-in-man study assesses the safety and medium-term patency performance of a new graft designed to induce stable laminar flow through the distal anastomosis.
Forty patients who required an infrainguinal bypass graft were recruited / registered from a number of centres in Belgium and The Netherlands. Thirty-nine received a Spiral Laminar Flow graft as part of a standard treatment protocol (23 above-the-knee and 16 below-the-knee bypasses). Kaplan Meier analyses were used to calculate primary and secondary patency rates.
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 unchanged for above-the-knee bypasses and were 86%, 64%, and 64%, respectively, for below-the-knee bypasses. There were no amputations in the study population.
This first-in-man series shows potential for the idea of spiral flow enhanced prosthetic grafts. As always, randomised studies are required to explore the role of different enhanced prosthetic grafts.