title: Effectiveness of haemodialysis access with an autologous tissue-engineered vascular graft: a multicentre cohort study.
abstract: 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 first 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 effectiveness after haemodialysis was started.
  
  
  RESULTS
  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 One patient was withdrawn from the study because of severe gastrointestinal bleeding shortly before implantation, and another died of unrelated causes during the safety period with a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 five patients had grafts functioning for haemodialysis 6-20 months after implantation, and a total of 68 patient-months of patency. In these five 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 five (60%) of the remaining eight patients 6 months after implantation.
  
  
  CONCLUSIONS
  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 fistulas, averaged across all patient populations.
authors.affiliation: Cytograft Tissue Engineering, Novato, CA, USA.
authors.forename: Todd N
authors.initials: TN
authors.lastname: McAllister
authors.forename: Marcin
authors.initials: M
authors.lastname: Maruszewski
authors.forename: Sergio A
authors.initials: SA
authors.lastname: Garrido
authors.forename: Wojciech
authors.initials: W
authors.lastname: Wystrychowski
authors.forename: Nathalie
authors.initials: N
authors.lastname: Dusserre
authors.forename: Alicia
authors.initials: A
authors.lastname: Marini
authors.forename: Krzysztof
authors.initials: K
authors.lastname: Zagalski
authors.forename: Alejandro
authors.initials: A
authors.lastname: Fiorillo
authors.forename: Hernan
authors.initials: H
authors.lastname: Avila
authors.forename: Ximena
authors.initials: X
authors.lastname: Manglano
authors.forename: Jorge
authors.initials: J
authors.lastname: Antonelli
authors.forename: Alfred
authors.initials: A
authors.lastname: Kocher
authors.forename: Marian
authors.initials: M
authors.lastname: Zembala
authors.forename: Lech
authors.initials: L
authors.lastname: Cierpka
authors.forename: Luis M
authors.initials: LM
authors.lastname: de la Fuente
authors.forename: Nicolas
authors.initials: N
authors.lastname: L'heureux
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001166:Arteriovenous Shunt, Surgical; D001705:Bioprosthesis; D001807:Blood Vessel Prosthesis; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007676:Kidney Failure, Chronic / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D006435:Renal Dialysis; D013997:Time Factors; D023822:Tissue Engineering / Q000379:methods*; D016896:Treatment Outcome; D014654:Vascular Patency