Abstract
A new expanded-polytetrafluoroethylene (E-PTFE) vascular graft, Diastat®, designed to be used for blood access to perform hemodialysis, was developed. It contains a cannulation segment consisting of a stretch E-PTFE base tube surrounded by round E-PTFE fibers secured by a thin, perforated E-PTFE cover. Between July 1995 and August 1996, 65 Diastat® arteriovenous access implantations were performed in 62 patients in whom autogenous fistula construction was impossible. The mean age of the patients (mean±SD) was 54.9±11.5 years, the duration of hemodialysis at the time of implantation was 10.8±7.4 years, and the number of previous vascular access operations was 5.6±5.8. Eleven grafts were implanted in the forearm, 36 in the upper arm via the forearm, 14 in the upper arm, and 4 in the groin. After each dialysis session, a questionnaire evaluating the following parameters was completed by the dialysis personnel: difficulty of puncture, hemostasis after needle removal, and postoperative perigraft edema. The questionnaire results indicated that bleeding from the needle holes of 64 (50.0%) of the 128 Diastats® stopped in 5min, and in 10min in 40 (31.3%), in 15min in 14 (10.9%), and in more than 20min in 10 (7.8%). Difficulty in making the puncture was evaluated as easier in 53 of the 131 punctures (40.5%), the same in 66 (50.4%), and more difficult in 12 (9.2%). Postoperative perigraft edema was mild in 38 of the 62 patients (61.3%), moderate in 19 (30.6%), and severe in 5 (8.1%). Eleven of the 14 thrombosed grafts were salvaged, 8 by thrombectomy, and 3 by bypass grafting at the venous anastomosis with conventional E-PTFE grafts. Graft infections occurred in 6 patients (9.2%), and required total excision to eradicate the infection in 3 of them. Surgical treatment was performed in 3 of the 4 patients who developed venous hypertension and in 1 of the 4 patients with steal syndrome. No seroma formation or aneurysmal dilatation was found after implantation. The overall cumulative patency of Diastat® was 78% at 6 months and 74% at 10 months. The prompt hemostasis and minimal local edema confirm the suitability of the design concept of Diastat® for safe and early cannulation. It is concluded that Diastat® is preferable to the conventional E-PTFE graft as a vascular graft for hemodialysis.
