A prospective, randomized comparison of bovine carotid artery and expanded polytetrafluoroethylene for permanent hemodialysis vascular access

Kennealey, Peter; Elias, Nahel; Hertl, Martin; Ko, Dicken S.C.; Saidi, Reza F.; Markmann, James F.; Smoot, Elizabeth E.; Schoenfeld, David; Kawai, Tatsuo

doi:10.1016/j.jvs.2011.02.008

Cited by 67 publications

(68 citation statements)

References 25 publications

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“…1G,H). Commercially available decellularized xenografts, such as the Artegraft Bovine Carotid Arteries ™ , demonstrated significantly higher patency rates (60.5% with 26 patients) than polytetrafluoroethylene grafts (10.1% with 27 patients) at 1 year post implantation [102]. To enhance integration and remodeling of decellularized scaffolds, cells are often seeded onto the decelluarlized scaffolds prior to implantation [103].…”

Section: Decellularized Vascular Scaffolds For Vascular Engineeringmentioning

confidence: 99%

Engineering of arteries in vitro

Huang

Niklason

2014

Cell. Mol. Life Sci.

107

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This review will focus on two elements that are essential for functional arterial regeneration in vitro: the mechanical environment and the bioreactors used for tissue growth. The importance of the mechanical environment to embryological development, vascular functionality, and vascular graft regeneration will be discussed. Bioreactors generate mechanical stimuli to simulate the biomechanical environment of the arterial system. This system has been used to reconstruct arterial grafts with appropriate mechanical strength for implantation by controlling the chemical and mechanical environments in which the grafts are grown. Bioreactors are powerful tools to study the effect of mechanical stimuli on extracellular matrix (ECM) architecture and the mechanical properties of engineered vessels. Hence biomimetic systems enable us to optimize chemo-biomechanical culture conditions to regenerate engineered vessels with physiological properties similar to those of native arterial vessels. In addition, this review will introduce and examine various approaches and techniques that have been used to engineer biologically-based vascular grafts, including collagen-based grafts, fibrin-gel grafts, cell sheet engineering, biodegradable polymers, and decellularization of native vessels.

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Section: Decellularized Vascular Scaffolds For Vascular Engineeringmentioning

confidence: 99%

Engineering of arteries in vitro

Huang

Niklason

2014

Cell. Mol. Life Sci.

107

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“…5 Many biological alternatives to ePTFE for dialysis access have been studied, but none has gained wide acceptance. Bovine carotid artery grafts 6,7 have been shown to provide acceptable patency in only small, single-centre studies, and depopulated bovine ureters and bovine mesenteric vein are prone to stenosis and aneurysm. 8–13 Cryopreserved human vein shows some tendency for dilatation and could increase panel-reactive antibodies, 14 whereas a previous autologous tissue-engineered conduit was subject to structural degradation and aneurysm formation.…”

Section: Introductionmentioning

confidence: 99%

Bioengineered human acellular vessels for dialysis access in patients with end-stage renal disease: two phase 2 single-arm trials

et al. 2016

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Summary Background For patients with end-stage renal disease who are not candidates for fistula, dialysis access grafts are the best option for chronic haemodialysis. However, polytetrafluoroethylene arteriovenous grafts are prone to thrombosis, infection, and intimal hyperplasia at the venous anastomosis. We developed and tested a bioengineered human acellular vessel as a potential solution to these limitations in dialysis access. Methods We did two single-arm phase 2 trials at six centres in the USA and Poland. We enrolled adults with end-stage renal disease. A novel bioengineered human acellular vessel was implanted into the arms of patients for haemodialysis access. Primary endpoints were safety (freedom from immune response or infection, aneurysm, or mechanical failure, and incidence of adverse events), and efficacy as assessed by primary, primary assisted, and secondary patencies at 6 months. All patients were followed up for at least 1 year, or had a censoring event. These trials are registered with ClinicalTrials.gov, NCT01744418 and NCT01840956. Findings Human acellular vessels were implanted into 60 patients. Mean follow-up was 16 months (SD 7·6). One vessel became infected during 82 patient-years of follow-up. The vessels had no dilatation and rarely had post-cannulation bleeding. At 6 months, 63% (95% CI 47–72) of patients had primary patency, 73% (57–81) had primary assisted patency, and 97% (85–98) had secondary patency, with most loss of primary patency because of thrombosis. At 12 months, 28% (17–40) had primary patency, 38% (26–51) had primary assisted patency, and 89% (74–93) had secondary patency. Interpretation Bioengineered human acellular vessels seem to provide safe and functional haemodialysis access, and warrant further study in randomised controlled trials. Funding Humacyte and US National Institutes of Health.

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“…Although there was no difference in secondary patency, primary and assisted primary patency were higher with bovine carotid than with ePTFE (60% versus 10% and 60% versus 21% at 1 year, respectively). 24 Although bovine carotid has not been studied in vascular trauma, experience suggests that it may be a valid consideration in select cases. Similarly, bovine jugular vein plays a role in reconstruction of the right ventricular outflow tract in congenital heart surgery.…”

Section: Biologic Conduits: Xenograftsmentioning

confidence: 99%