ProCol<sup>®</sup> Vascular Bioprosthesis for Vascular Access: Midterm Results

Hatzibaloglou, A.; Velissaris, Ioannis; Kaitzis, D.; Grekas, Dimitrios; Avdelidou, Aphrodite; Kiskinis, Dimitrios

doi:10.1177/112972980400500104

Cited by 21 publications

(12 citation statements)

References 7 publications

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“…15 Other biological grafts such as bovine mesenteric vein and depopulated ureters also have substantial rates of dilatation. 8,11 By contrast, we recorded no true aneurysms in the implanted vessels at any time. The small perigraft haematomas or pseudoaneurysms we report were probably cannulation site injuries caused by needle access, and are consistent with all forms of both prosthetic and autogenous vascular access.…”

Section: Discussionmentioning

confidence: 52%

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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Section: Discussionmentioning

confidence: 52%

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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“…As was widely described, brachial arteries are usually used in the arteriovenous hemodialysis access confection [23]. According to the findings reported in this study, the viscoelastic differences were associated with structural variations that could be involved in the origin of the intimal hyperplasia and the vascular access dysfunction.…”

Section: Discussionmentioning

confidence: 66%

Structural and Functional Properties of Venous Wall: Relationship between Elastin, Collagen, and Smooth Muscle Components and Viscoelastic Properties

Zócalo¹,

Bia²,

Cabrera-Fischer

et al. 2013

ISRN Physiology

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The aims of this work were (1) to analyze the viscoelastic behavior of different venous segments and their differences, considering the structural characteristics (elastin, collagen, and smooth muscle content) of the venous wall; (2) to analyze the venous biomechanical behavior by means of the histological characteristics of the veins. Nine healthy male Corriedale sheep were included. One vein was selected from each animal to evaluate its biomechanical properties: (a) anterior vena cava, (b) right jugular vein, and (c) right femoral vein. Each selected vein was instrumented with pressure and diameter sensors. After excision, a small ring-shaped sample was set apart from each segment for histological analysis. The amounts of elastin, collagen and smooth muscle were correlated to calculated biomechanical parameters (high-and low-pressure compliance and viscosity). Conclusions are the following: (1) the viscoelastic behavior of the venous wall varies depending on the vascular territory, and it is associated with the variation of the histological structure. These differences involve muscle (both smooth and striated), elastin, and collagen contents. (2) In addition, the quantity of collagen was negatively correlated with high-and low-pressure compliances, and (3) the smooth muscle content was higher in peripheral veins and is positively correlated with venous wall viscosity.

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“…Most retrospective studies suggest that ePTFE grafts are superior to bovine artery grafts because the former are associated with less infection and thrombosis and have a longer patency period 129–144. Decellularized xenografts made from bovine mesenteric veins145–148 or bovine ureters149,150 have become available recently. Some clinical studies have suggested that these new bovine grafts may offer a safe alternative to patients who have a history of failed ePTFE grafts, but data are very limited 145.…”

Section: Prevention Strategiesmentioning

confidence: 99%

Neointimal hyperplasia associated with synthetic hemodialysis grafts

Terry

Shiu

et al. 2008

Kidney International

114

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Stenosis is a major cause of failure of hemodialysis vascular grafts and is primarily caused by neointimal hyperplasia (NH) at the anastomoses. The objective of this article is to provide a scientific review of the biology underlying this disorder and a critical review of the state-of-the-art investigational preventive strategies in order to stimulate further research in this exciting area. The histology of the NH shows myofibroblasts (that are probably derived from adventitial fibroblasts), extracellular matrices, pro-inflammatory cells including foreign-body giant cells, a variety of growth factors and cytokines, and neovasculature. The contributing factors of the pathogenesis of NH include surgical trauma, bioincompatibility of the synthetic graft, and the various mechanical stresses that result from luminal hypertension and compliance mismatch between the vessel wall and graft. These mechanical stimuli are focal in nature and may have a significant influence on the preferential localization of the NH. Novel mechanical graft designs and local drug delivery strategies show promise in animal models in preventing graft NH development. Successful prevention of graft stenosis would provide a superior alternative to the native fistula as hemodialysis vascular access.

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ProCol^® Vascular Bioprosthesis for Vascular Access: Midterm Results

Abstract: Our midterm results demonstrated that the ProCol vascular bioprosthesis was a promising material for VA with good patency and low complication rates.

Cited by 21 publications

References 7 publications

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

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

Structural and Functional Properties of Venous Wall: Relationship between Elastin, Collagen, and Smooth Muscle Components and Viscoelastic Properties

Neointimal hyperplasia associated with synthetic hemodialysis grafts

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ProCol® Vascular Bioprosthesis for Vascular Access: Midterm Results

Abstract: Our midterm results demonstrated that the ProCol vascular bioprosthesis was a promising material for VA with good patency and low complication rates.

Cited by 21 publications

References 7 publications

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

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

Structural and Functional Properties of Venous Wall: Relationship between Elastin, Collagen, and Smooth Muscle Components and Viscoelastic Properties

Neointimal hyperplasia associated with synthetic hemodialysis grafts

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Product

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ProCol^® Vascular Bioprosthesis for Vascular Access: Midterm Results