A prospective randomized study of three expanded polytetrafluoroethylene (PTFE) grafts as small arterial substitutes. 1978

O M Hastings, and K M Jain, and R W Hobson, and K G Swan

A prospective, double-blind, randomized study was performed to determine the relative patency rate of polytetrafluoroethylene (PTFE) grafts, Gore-Tex, Impra, and a Surgikos prototype PTFE graft. The 48 grafts (40 x 4 mm) replaced excised segments of femoral arteries in adult mongrel dogs, whose mean weight was 20.6 +/- 0.9 kg; the grafts were removed after 12 weeks. Sterile technique and antibiotic therapy were included in the study. Anticoagulation was not employed. Anastomoses were performed with 6 = 0 polypropylene. Angiographic assessment of each anastomosis was made at surgery and prior to sacrifice. Patency was assessed daily by palpation and Doppler flow signals, as well as angiographically, prior to sacrifice. The overall patency rate was 62.5%. There were no statistically significant differences in patency rates among the three groups (Gore-Tex, 56%; Impra, 75%, Surgikos, 56%). Histologic evaluation revealed incomplete neointima formation and significant pannus formation in all three types of grafts without any significant discernible difference among them. The results suggest that further experimental evaluation of PTFE, as a small vessel substitute, is indicated prior to its use clinically in preference to autogenous vein.

UI MeSH Term Description Entries
D011138 Polytetrafluoroethylene Homopolymer of tetrafluoroethylene. Nonflammable, tough, inert plastic tubing or sheeting; used to line vessels, insulate, protect or lubricate apparatus; also as filter, coating for surgical implants or as prosthetic material. Synonyms: Fluoroflex; Fluoroplast; Ftoroplast; Halon; Polyfene; PTFE; Tetron. FEP,Fluon,Politef,Polytef,TFE,Teflon,Expanded PTFE,Fluoroplast,GORE-TEX,Goretex,PTFE,Tarflen,GORE TEX,PTFE, Expanded
D011183 Postoperative Complications Pathologic processes that affect patients after a surgical procedure. They may or may not be related to the disease for which the surgery was done, and they may or may not be direct results of the surgery. Complication, Postoperative,Complications, Postoperative,Postoperative Complication
D011446 Prospective Studies Observation of a population for a sufficient number of persons over a sufficient number of years to generate incidence or mortality rates subsequent to the selection of the study group. Prospective Study,Studies, Prospective,Study, Prospective
D001807 Blood Vessel Prosthesis Device constructed of either synthetic or biological material that is used for the repair of injured or diseased blood vessels. Vascular Prosthesis,Blood Vessel Prostheses,Tissue-Engineered Vascular Graft,Graft, Tissue-Engineered Vascular,Grafts, Tissue-Engineered Vascular,Prostheses, Blood Vessel,Prostheses, Vascular,Prosthesis, Blood Vessel,Prosthesis, Vascular,Tissue Engineered Vascular Graft,Tissue-Engineered Vascular Grafts,Vascular Graft, Tissue-Engineered,Vascular Grafts, Tissue-Engineered,Vascular Prostheses,Vessel Prostheses, Blood,Vessel Prosthesis, Blood
D002986 Clinical Trials as Topic Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries. Clinical Trial as Topic
D004285 Dogs The domestic dog, Canis familiaris, comprising about 400 breeds, of the carnivore family CANIDAE. They are worldwide in distribution and live in association with people. (Walker's Mammals of the World, 5th ed, p1065) Canis familiaris,Dog
D004311 Double-Blind Method A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment. Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D005263 Femoral Artery The main artery of the thigh, a continuation of the external iliac artery. Common Femoral Artery,Arteries, Common Femoral,Arteries, Femoral,Artery, Common Femoral,Artery, Femoral,Common Femoral Arteries,Femoral Arteries,Femoral Arteries, Common,Femoral Artery, Common
D000818 Animals Unicellular or multicellular, heterotrophic organisms, that have sensation and the power of voluntary movement. Under the older five kingdom paradigm, Animalia was one of the kingdoms. Under the modern three domain model, Animalia represents one of the many groups in the domain EUKARYOTA. Animal,Metazoa,Animalia
D001158 Arteries The vessels carrying blood away from the heart. Artery

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