Eff ectiveness of haemodialysis access with an autologous tissue-engineered vascular graft: a multicentre cohort study

Background Application of a tissue-engineered vascular graft for small-diameter vascular reconstruction has been a long awaited and much anticipated advance for vascular surgery. We report results after a minimum of 6 months of follow-up for the fi rst ten patients implanted with a completely biological and autologous tissue-engineered vascular graft. Methods Ten patients with end-stage renal disease who had been receiving haemodialysis through an access graft that had a high probability of failure, and had had at least one previous access failure, were enrolled from centres in Argentina and Poland between September, 2004, and April, 2007. Completely autologous tissue-engineered vascular grafts were grown in culture supplemented with bovine serum, implanted as arteriovenous shunts, and assessed for both mechanical stability during the safety phase (0–3 months) and eff ectiveness after haemodialysis was started. Findings Three grafts failed within the safety phase, which is consistent with failure rates expected for this high-risk patient population. One patient was withdrawn from the study because of severe gastrointestinal bleeding shortly before implantation, and another died of unrelated causes during the safety period with a patent graft. The remaining fi ve patients had grafts functioning for haemodialysis 6–20 months after implantation, and a total of 68 patient-months of patency. In these fi ve patients, only one intervention (surgical correction) was needed t