Effectiveness 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 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 One patient was withdrawn from the study because of severe gastrointestinal bleeding shortly before implantation, and another died of unrelated causes during the safety period with a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.
McAllister
Todd N
TN
Cytograft Tissue Engineering, Novato, CA, USA.
Maruszewski
Marcin
M
Garrido
Sergio A
SA
Wystrychowski
Wojciech
W
Dusserre
Nathalie
N
Marini
Alicia
A
Zagalski
Krzysztof
K
Fiorillo
Alejandro
A
Avila
Hernan
H
Manglano
Ximena
X
Antonelli
Jorge
J
Kocher
Alfred
A
Zembala
Marian
M
Cierpka
Lech
L
de la Fuente
Luis M
LM
L'heureux
Nicolas
N
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