Clinical trial of a self-sealing PTFE-silicone dialysis graft

A double wall PTFE graft with a silicone rubber middle layer (PTFE-sil) shown in a canine model to be self-sealing after needle puncture, was tried in 30 dialysis patients. Thirty-five patients with PTFE grafts were controls. All patients were followed for 1 year. In the PTFE-sil group, mean time to first dialysis was 1.3 days after implantation; during first 10 treatments, 17% of punctures did not bleed, 61% bled minimally, and 4% required 10 or more minutes of compression. No bleeding complications were encountered at any time. Complications of PTFE-sil vs. PTFE were as follows: thrombosis 36.6% vs. 28.5%; infection 13.3% vs. 11.4%; seroma 3% vs. 0%; steal 3% vs. 0%; pseudoaneurysm 0% vs. 17.1%; one year primary patency 63% vs. 66%; secondary patency 75% vs. 67%. In conclusion, the PTFE-sil graft, can be used immediately after implantation, sparing patient additional access procedures for acute dialysis. This results in less morbidity, decrease in bleeding complications, considerable shortening of hospital stay and significant reduction in expenses.