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

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 S eptember, 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 One patient was withdrawn from the study because of severe gastrointestinal bleeding shortly before implantation, and another died of unrelated causes during the safety period with a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 to maintain secondary patency. Overall, primary patency was maintained in seven (78%) of the remaining nine patients 1 month after implantation and fi ve (60%) of the remaining eight patients 6 months after implantation. Interpretation Our proportion of primary patency in this high-risk cohort approaches Dialysis Outcomes Quality Initiative objectives (76% of patients 3 months after implantation) for arteriovenous fi stulas, averaged across all patient populations.