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

Author(s): P. A. Stonebridge, F. Vermassen, J. Dick, J. J. Belch, G. Houston

Abstract:
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.

Full version: Available here

Click the link to go to an external website with the full version of the paper


ISBN: 1615-5947 (Electronic) 0890-5096 (Linking)
Publication Year: 2012
Periodical: Ann Vasc Surg
Periodical Number:
Volume:
Pages:
Author Address: Division of Cardiovascular Research, Ninewells Hospital and Medical School, University of Dundee, Dundee, Scotland; and Division of Vascular and Thoracic Surgery, University of Ghent, Ghent, Belgium.