テルモ社製透析用人工血管(TRE‐687)の特徴とその臨床使用報告

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  • Feature and clinical use report of Terumo graft for hemodialysis (TRE-687).

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We conducted a clinical study of a newly developed self-sealing vascular graft for hemodialysis (TRE-687 by Terumo Corporation) to evaluate its efficacy and safety. TRE-687 grafts were implanted to 71 end-stage renal disease (ESRD) patients between September 1999 and March 2002. The patients consisted of 36 males and 35 females with an average age of 64.1±13.1 years old (mean±SD). The duration of the dialyses at the time of implantation was 0 to 31 years and 7 months. In 42 patients, the THE-687 was implanted in the forearm, the upper arm in 6 via the forearm, the upper arm, in 13 and the groin in 10. Evaluation of manipulability during anastomosis of the THE-687 to the host's vessels was easier or equal to ePTFE in 70 of 71 patients, and there was no hemorrhage from the suture holes in THE-687 in any patient. In 68 patients undergoing blood access, the average interval until the first puncture was 9.8 days after implantation, and it was possible to obtain blood access within 7 days after implantation in 37 patients (54.4%). Manipulability in needle puncturing was easier or equal to ePTFE in 286 of 292 punctures (97.9%), and the average hemostasis time after removal of the needle was 6.5±3.3 minutes (unknown for 3 punctures.).<br>Fifty-five adverse events occurred in 38 patients, but none of these events were related to TRE-687. During the course of the study (12 months after implantation), 57 percutaneous transluminal angioplasties (PTA), 49 thrombectomies, 8 partial replacements, and 9 changes in anastomotic site were performed as a salvage procedures for TRE-687. The cumulative secondary patency rate 12 months after implantation was 80.4%.<br>Therefore, it was confirmed that THE-687 has certain advantages: 1) allowing early cannulation 2) good manipulability on needle puncturing and prompt hemostasis as a blood access for ESRD patients.

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