Clinical trial of new polyurethane vascular grafts for hemodialysis: compared with expanded polytetrafluoroethylene grafts.
We developed a new polyurethane vascular access graft coated with gelatin and reinforced with knitted polyester fibers (PE-PEUG). Advantages over expanded-polytetrafluoroethylene graft (E-PTFEG) were previously reported in experimental studies. Between May 1990 and August 1992, 39 PE-PEUGs including 34 loop and 5 straight and 18 E-PTFEGs including 18 loop were implanted to create arteriovenous (AV) fistulas in a total of 52 adult patients on maintenance hemodialysis (HD). They were followed up until October 1994. Hemostasis on the suture line was achieved within 3 min in all patients implanted with PE-PEUGs. Bleeding from the needle holes of PE-PEUG stopped within 10 min with gentle finger pressure. Minimal local edema developed in only a few patients implanted with PE-PEUG while most patients implanted with E-PTFEG developed moderate local edema. One seroma formation was found in an E-PTFE case. Aneurysmal dilatations were observed twice in a PE-PEUG patient 9 and 17 months after the implantation and once in a E-PTFEG patient 2 years after the implantation. The cumulative patency rate at 1 year in the PE-PEUG and E-PTFEG groups were 53.2 and 70.8%, respectively. Our clinical study showed that the PE-PEUG had several advantages over E-PTFEG: prompt hemostasis, no persistent edema and no formation of seroma, no change in elasticity, and sufficient mechanical strength. However, the cumulative patency rate was inferior to that with E-PTFEG implanted in our series. Further modifications are therefore necessary to improve the patency rate.
Nakagawa
Y
Y
Third Department of Surgery, Tokyo Women's Medical College, Japan.
Ota
K
K
Sato
Y
Y
Teraoka
S
S
Agishi
T
T
D000328:Adult; D000368:Aged; D001164:Arteriovenous Fistula; D001672:Biocompatible Materials / Q000378:metabolism*; D001807:Blood Vessel Prosthesis / Q000592:standards*; D004487:Edema / Q000473:pathology; D005260:Female; D005780:Gelatin / Q000378:metabolism; D006083:Graft Occlusion, Vascular; D006706:Homeostasis; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008855:Microscopy, Electron, Scanning; D008875:Middle Aged; D011138:Polytetrafluoroethylene / Q000378:metabolism; D011140:Polyurethanes / Q000378:metabolism; D019736:Prostheses and Implants; D006435:Renal Dialysis / Q000592:standards*
D001672:Biocompatible Materials; D011140:Polyurethanes; D005780:Gelatin; D011138:Polytetrafluoroethylene