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

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.

• Authors: Y Nakagawa, K Ota, Y Sato, S Teraoka, T Agishi
• Journal: Artificial organs (Artif Organs) Vol. 19 Issue 12 Pg. 1227-32 (Dec 1995) ISSN: 0160-564X [Print] United States
• PMID: 8967879 (Publication Type: Clinical Trial, Comparative Study, Controlled Clinical Trial, Journal Article)

Chemical References

• Biocompatible Materials
• Polyurethanes
• Gelatin
• Polytetrafluoroethylene

Topics

• 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)