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Clinical Trial of New Polyurethane Vascular Grafts for Hemodialysis: Compared with Expanded Polytetrafluoroethylene Grafts
Author(s) -
Nakagawa Yoshihiko,
Ota Kazuo,
Sato Yuichi,
Teraoka Satoshi,
Agishi Tetsuzo
Publication year - 1995
Publication title -
artificial organs
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.684
H-Index - 76
eISSN - 1525-1594
pISSN - 0160-564X
DOI - 10.1111/j.1525-1594.1995.tb02290.x
Subject(s) - seroma , medicine , hemostasis , surgery , hemodialysis , edema , polytetrafluoroethylene , complication , materials science , metallurgy
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 lo cal 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.