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BackgroundThe long-term prognosis of arteriovenous (AV) polytetrafluoroethylene (PTFE) hemodialysis grafts is dissatisfying. Responsible for the poor outcome is a stenosis of the venous anastomosis. This originates from both pseudointimal (PI) and neointimal hyperplasia (IH) development. Although cuffed grafts have a better short-term prognosis than straight grafts, the late results of both types are poor. This current study aimed to compare both arteriovenous straight and Venaflo-type (Bard, Tempe, Ariz) prostheses in an animal study with regard to patency, PI, and IH development.MethodsSixteen iliac arteriovenous expanded polytetrafluoroethylene (ePTFE) loops were inserted into 16 pigs. Animals were randomized into two groups. Group 1 animals received straight configured ePTFE grafts and group 2 animals received grafts with a Venaflo-type cuffed venous anastomosis. After insertion of the shunts and immediately before graft harvest, the shunt flows were measured. Six weeks after implantation, patency rates and development of pseudointima (PI) within the grafts were noted. The thickness of the venous intimal hyperplasia was measured using digital planimetry.ResultsPatency rates after 6 weeks were 25% for straight and 62% for Venaflo-type grafts. In both groups a significant decrease of the graft blood flow compared with the preoperative levels was observed, which was attributed to the marked development of pseudointima. The reduction in flow at graft harvest was greater in the straight ePTFE group (658 ± 68 vs 260 ± 42 mL/min, P < .05) than for the Venaflo-type grafts (770 ± 107 vs 661 ± 284 mL/min, P = ns), but the differences between the groups were statistically not significant. A marked pseudointima developed in the Venaflo cuff. The PI development was significantly higher in the graft hood (2.9 ± 0.6 mm) than in the heel (2.5 ± 0.4 mm, P < .05). In both groups, an intimal hyperplasia formed on the vein wall just opposite to the graft inflow. The intimal hyperplasia development was more pronounced in the straight configured shunts.ConclusionsThe results of the present study confirm the inferior clinical results of ePTFE grafts used for hemodialysis access. Although the patency rates of cuffed grafts were superior, in both graft types a significant pseudointima leading to subtotal graft stenosis was observed in all grafts. Both straight and Venaflo-grafts. The Venaflo grafts have a slightly bettertype cuffed ePTFE grafts have major hemodynamic drawbacks that have to be addressed in future graft design efforts.Clinical RelevanceArteriovenous grafts have a poor long-term prognosis. The problem in most cases is the development of a stenosis at the graft vein anastomosis. Currently, two different graft types are available, the straight and the Venaflo-type grafts. The Venaflo grafts have a slightly better outcome compared with the straight grafts. However, there are only clinical data available. The amount of pseudointima and intimal hyperplasia development is not exactly known. We therefore aimed to compare both graft types in a controlled animal setting. This is the first time that both graft types are evaluated using a randomized controlled animal study.

IntroductionThe long-term prognosis of arteriovenous polytetrafluoroethylene (PTFE) hemodialysis grafts remains poor, causing significant morbidity and costs. The high failure rate is due to a stenosis development of the graft-vein anastomosis, consisting of two pathophysiologically separate and characteristic lesions emerging from two main mechanisms: development of intimal hyperplasia in the vein and pseudointima in the graft. We developed a new venous anastomotic graft design that combines a flow diffuser and flow division, thereby creating a double-channel graft (Bi-Flow graft) and tested it in vitro.MethodsIn vitro experiments have been performed using silastic models of six different anastomotic configurations (straight end-to-side, cuffed Venaflo-type, large and small diffuser, and large and small Bi-Flow) inserted into a pulsatile-flow circuit. The silastic models were created using a computerized numerical control design approach, varying only the venous anastomoses. Velocity fields and shear stresses were obtained using particle image velocimetry, and volumetric flow rates through the models were measured using an ultrasound flowmeter.ResultsThe hooded graft configurations showed significantly lower shear forces than did the end-to-side anastomosis. The shear stresses in the straight end-to-side graft were as high as arterial wall stresses. Large separation areas were present in the hooded grafts, except for the small Bi-Flow graft, which showed only isolated separation zones near the baffle used to divide the flow. The double-channel grafts exhibited a parabolic flow profile consisting of laminar flow in the double-outflow portion of the model's laminar flow pattern through the venous anastomosis. A marked flow separation was present in the large Bi-Flow model. Volumetric flow measurements revealed an average flow increase of 21% through the small Bi-Flow graft, which was attributed to the optimization of flow dynamics and pattern within the venous anastomosis of the double-channel graft.ConclusionThe new arteriovenous Bi-Flow graft design addresses two major problems responsible for the development of venous stenosis of prosthetic hemodialysis grafts in vitro. The new graft design should be further investigated in animal studies.Clinical RelevanceArteriovenous polytetrafluoroethylene grafts have a poor long-term prognosis, and most are occluded after only 2 years. The most important cause is the development of a venous anastomotic stenosis. The stenosis consists of venous intimal hyperplasia and graft pseudointima that narrows the lumen. The intimal hyperplasia results predominantly from high wall shear stresses, and the pseudointima develops within flow separation areas near the polytetrafluoroethylene wall. We developed a new arteriovenous graft design, which combines a flow diffuser to decrease flow velocity and resulting shear stress with a baffle that divides the outflow tract, thus forming two separate channels. The new graft was investigated using particle image velocimetry and volumetric flow measurements.