Spiral laminar flow prosthetic bypass graft: medium-term results from a first-in-man structured registry study.
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.


METHODS
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.


CONCLUSIONS
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.
Division of Cardiovascular Research, Ninewells Hospital and Medical School, University of Dundee, Dundee, Scotland. p.a.stonebridge@dundee.ac.uk
Peter A
PA
Stonebridge
Frank
F
Vermassen
John
J
Dick
Jill J F
JJ
Belch
Graeme
G
Houston
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001530:Belgium; D001783:Blood Flow Velocity; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation*; D005260:Female; D006083:Graft Occlusion, Vascular / Q000209:etiology / Q000503:physiopathology; D006801:Humans; D053208:Kaplan-Meier Estimate; D023821:Limb Salvage; D035002:Lower Extremity / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D009426:Netherlands; D058729:Peripheral Arterial Disease / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D011446:Prospective Studies; D011474:Prosthesis Design; D012039:Regional Blood Flow; D012042:Registries; D013314:Stress, Mechanical; D013997:Time Factors; D016896:Treatment Outcome; D018615:Ultrasonography, Doppler, Color; D014654:Vascular Patency