Background: 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-many study assesses the safety and medium-term patency performance of a new graft designed to induce stable laminar flow through the distal anastomosis. Method: Forty patients who required an infrainguinal bypass graft were recruited/registered from a number of centers 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. 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 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. Conclusion: This first-in-man series shows potential for the idea of spiral flow-enhanced prosthetic grafts. As always, randomized studies are required to explore the role of different enhanced prosthetic grafts.
Stonebridge, P. A., Vermassen, F., Dick, J., Belch, J. J. F., & Houston, G. (2012). Spiral laminar flow prosthetic bypass graft: Medium-term results from a first-in-man structured registry study. Annals of Vascular Surgery, 26(8), 1093-1099. https://doi.org/10.1016/j.avsg.2012.02.001