McAllister Todd N, Maruszewski Marcin, Garrido Sergio A, Wystrychowski Wojciech, Dusserre Nathalie, Marini Alicia, Zagalski Krzysztof, Fiorillo Alejandro, Avila Hernan, Manglano Ximena, Antonelli Jorge, Kocher Alfred, Zembala Marian, Cierpka Lech, de la Fuente Luis M, L'heureux Nicolas
Cytograft Tissue Engineering, Novato, CA, USA.
Lancet. 2009 Apr 25;373(9673):1440-6. doi: 10.1016/S0140-6736(09)60248-8.
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.
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.
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 One patient was withdrawn from the study because of severe gastrointestinal bleeding shortly before implantation, and another died of unrelated causes during the safety period with a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.
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.
组织工程血管移植物用于小直径血管重建一直是血管外科期待已久且备受瞩目的进展。我们报告了首批十例植入完全生物性和自体组织工程血管移植物患者至少随访6个月后的结果。
2004年9月至2007年4月期间，从阿根廷和波兰的中心招募了十例终末期肾病患者，这些患者通过极有可能失败且至少有过一次先前通路失败的动静脉内瘘进行血液透析。完全自体组织工程血管移植物在添加牛血清的培养基中培养，作为动静脉分流植入，并在安全阶段（0 - 3个月）评估其机械稳定性，在开始血液透析后评估其有效性。
在安全阶段有3个移植物失败，这与该高风险患者群体预期的失败率一致。一名患者在植入前不久因严重胃肠道出血退出研究，另一名患者在安全期间因无关原因死亡，但其移植物通畅。其余五名患者的移植物在植入后6 - 20个月用于血液透析，总共有68个患者 - 月的通畅时间。在这五名患者中，仅需一次干预（手术矫正）来维持二级通畅。总体而言，其余九名患者中有七名（78%）在植入后1个月保持了初级通畅，其余八名患者中有五名（60%）在植入后6个月保持了初级通畅。
在这个高风险队列中，我们的初级通畅比例接近动静脉内瘘的透析结果质量改进计划目标（植入后3个月76%的患者），这是所有患者群体的平均水平。
