Clinical trial of new polyurethane vascular grafts for hemodialysis: compared with expanded polytetrafluoroethylene grafts

Artif Organs. 1995 Dec;19(12):1227-32. doi: 10.1111/j.1525-1594.1995.tb02290.x.

Abstract

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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Controlled Clinical Trial

MeSH terms

  • Adult
  • Aged
  • Arteriovenous Fistula
  • Biocompatible Materials / metabolism*
  • Blood Vessel Prosthesis / standards*
  • Edema / pathology
  • Female
  • Gelatin / metabolism
  • Graft Occlusion, Vascular
  • Homeostasis
  • Humans
  • Longitudinal Studies
  • Male
  • Microscopy, Electron, Scanning
  • Middle Aged
  • Polytetrafluoroethylene / metabolism
  • Polyurethanes / metabolism
  • Prostheses and Implants
  • Renal Dialysis / standards*

Substances

  • Biocompatible Materials
  • Polyurethanes
  • Gelatin
  • Polytetrafluoroethylene