Five Year Outcomes in Patients with End Stage Renal Disease Who Received a Bioengineered Human Acellular Vessel for Dialysis Access

• DOI: 10.1016/j.ejvsvf.2022.01.003
• Publication Date: 2022-01-10T11:20:49Z
• Authors: Tomasz Jakimowicz; Stanislaw Przywara; Jakub Turek; Alison Pilgrim; Michal Macech; Norbert Zapotoczny; Tomasz Zubilewicz; Jeffrey H. Lawson; Laura E. Niklason
• Keywords: Clinical endpoint

Patients with end stage renal failure who require haemodialysis suffer morbidity and mortality due to vascular access. Bioengineered human acellular vessels (HAVs) may provide a access option fewer complications than other grafts. In prospective phase II trial from 2012 2014 (NCT01744418), HAVs were implanted into 40 patients at three sites in Poland. The protocol for this "first man" use of the HAV contemplated only two years follow up, results initially reported 2016. light retained function seen many year time point, up still alive was extended total 10 years. This interim report, long term point five years, assessed patient conduit status those continued routine dialysis HAV.HAVs are bioengineered by culturing smooth muscle cells on biodegradable polymer matrix. study, patent implants 24 months followed every months, starting month 27 through 60, or least post-implantation. report contains functional histological data 29 original demonstrated point.Eleven completed 60. One maintained primary patency, secondary patency. Secondary patency estimated 58.2% (95% confidence interval 39.2-73.1) after censoring deaths (n = 8) withdrawals 1). No infections during period.This shows that vessel (HAV) durable disease.