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Purpose: To create a porcine hemodialysis access model that reliably reproduces intimal hyperplasia (IH) of the outflow vein similar to that which causes access failure in human patients undergoing dialysis treatments., Materials and Methods: Surgical technique for creation of side-to-side iliac-artery-to-ipsilateral-iliac-vein (IAV) native fistulas and IAV conduits was optimized in three standard-bred pigs. Persistent patency of fistulas and conduits was demonstrated in two additional pigs allowed to survive for 1 week. IAV fistulas and contralateral 2-cm polytetrafluoroethylene IAV conduits were created in five additional pigs. Venous outflow from these fistulas and conduits was evaluated with venography and intravascular ultrasound (IVUS) immediately after creation (day 0) and at 2-week intervals for as long as 64 days. Animals were killed at 30 days (n = 1), 42 days (n = 2), or 64 days (n = 2), and the arteries, veins, and conduits were evaluated histologically., Results: IAV native fistulas remained patent until the animals' death and conduits remained patent for at least 14 days in four of five pigs; both the fistula and conduit likely occluded before 16-day follow-up in the fifth pig. At 42-64 days, venography demonstrated maximum fistula outflow vein diameter stenoses of 53%-76% and maximum conduit outflow vein stenoses of 44%-84%, and IVUS demonstrated maximum area stenoses of 64%-86% and 43%-82%, respectively. Three of five conduits occluded, one before 16-day follow-up, one between 14 and 28 days, and the other after 42 days. Histologic sections demonstrated IH predominantly affecting the veins at the anastomoses and central (cephalad) to the anastomoses in all pigs., Conclusion: This porcine model reproduces IH in the fistula or conduit outflow vein with measurable stenosis. Such a model might allow relevant preclinical evaluation of interventional devices and techniques intended to reduce the effects of IH in human patients undergoing dialysis treatments.

Purpose: To determine the safety and short-term patency of a polytetrafluoroethylene (PTFE)-encapsulated carbon-lined endoluminal device (ED) deployed across the venous anastomosis of arteriovenous conduits., Materials and Methods: Arteriovenous grafts (n = 16) were created between femoral arteries and veins in eight female canines and allowed to mature 30 days +/- 5 (SD). Five were excluded before implantation because of thrombosis or intragraft stenosis. Deployment was conducted in the remaining 11 anastomoses. Fistulography and intravascular ultrasound (IVUS) were performed before and after the procedure and 1 month postimplantation. Stent migration, apposition, and stenosis were evaluated. The angle of the anastomosis was compared before and after deployment and at follow-up. Mural thrombus thickness, percentage of surface covering, and percentage of endothelialization within the device were measured histologically., Results: There was no significant migration. By explant, all devices were completely apposed. Stenosis occurred in three of nine grafts. The angle of the venous anastomosis decreased by 29.5 degrees (posteroanterior) and 32.4 degrees (oblique) after ED deployment. There was a further decrease of 6.1 degrees (posteroanterior) and 3.2 degrees (oblique) during the 4-week follow-up period. Hemostasis was difficult to achieve in this animal model. Five required more than 1 hour to achieve hemostasis manually. Six in three animals were closed with a Perclose device, achieving immediate hemostasis; however, three (one in each animal) re-bled intermittently 2 weeks after implantation for an average of 9.3 days. The puncture site of each graft that bled was radiographically shown abnormal., Conclusion: The ED can be deployed without stent migration and is completely apposed and patent after 4 weeks. Although bleeding was a problem with this animal model, delayed bleeding complications associated with puncture site abnormalities were seen only in grafts closed with a percutaneous suturing device.

Purpose: To determine whether gamma brachytherapy can prevent in-stent stenosis in hemodialysis grafts., Materials and Methods: Six-millimeter polytetrafluoroethylene arteriovenous grafts were created bilaterally in six dogs. After 1 month, Wallstents spanning the venous anastomosis were placed to accelerate restenosis. Gamma irradiation (12 Gy) was delivered endoluminally to one of the two grafts by using an iridium 192 source; thus, each animal served as its own control. Fistulography was performed monthly for 10 months or until graft thrombosis, with measurement of stenosis at each time point. At the conclusion of the study period, the treated area was examined histologically, and a computer model was used to calculate the volume of intimal hyperplasia., Results: Delayed stent migration resulted in exclusion of one dog. In the remaining five dogs; maximum stenosis across all time intervals was less for the treated side (P < .04), and the volume of intimal hyperplasia was less for the treated side (P < .045). In one animal studied at 1 year, this trend reversed in terms of percentage stenosis but not total neointimal volume., Conclusion: Brachytherapy with 192Ir (gamma) delivered at the time of stent placement reduces restenosis in this hemodialysis graft model, but, depending on the parameter evaluated (stenosis vs total volume of neointima), the benefit may wane or even reverse with time.

Purpose: To compare pulmonary emboli resulting from pulse-spray pharmacomechanical thrombolysis (PSPMT) and mechanical thrombolysis performed to declot dialysis-access grafts., Materials and Methods: Polytetrafluoroethylene arteriovenous shunts were created in eight dogs and were deliberately clotted at monthly intervals. Animals were randomly assigned to treatment with pulse-spray urokinase thrombolysis or a low-speed rotational percutaneous thrombolytic device. Perfusion imaging, pulmonary-artery pressure measurements, and pulmonary arteriography were performed before and after each procedure., Results: A total of 22 procedures were performed (11 PSPMT and 11 mechanical thrombolysis). Declotting was successful in all procedures, with 100% 30-day patency. Segmental defects were seen on perfusion images after 10 (91%) of 11 PSPMT procedures and two (18%) of 11 mechanical thrombolysis procedures (P < .002). Transient increases in pulmonary-artery pressure occurred in the PSPMT group. Complete resolution of emboli and return to baseline pressures were seen in all cases, even after multiple (up to four) procedures in the same animal. There was no histologic evidence of pulmonary infarction in either group., Conclusion: The percutaneous thrombolytic device is effective for declotting dialysis grafts in dogs and results in statistically significantly fewer pulmonary emboli compared with PSPMT.

Purpose: To develop a technique of percutaneous creation and/or revision of arteriovenous hemodialysis access grafts, and to study the feasibility of the technique in the acute setting., Materials and Methods: Arteriovenous shunts, consisting of silicone-covered Wallstents 6 (n = 10) or 8 (n = 1) mm in diameter and 11-17 cm in length, were created in 10 mongrel dogs. All shunts were created percutaneously except one, in which the carotid artery was exposed surgically and the jugular vein accessed percutaneously to create a straight external graft. All other grafts were femoral loops (femoral artery to femoral vein). Eight were tunneled subcutaneously and three were left external. All shunts were delivered through 10-F peel-away sheaths., Results: The 11 shunts were allowed to flow for a mean of 4 hours (range, 1.0-6.5 hours) before the animals were killed. Leakage around the "anastomoses" was not observed. Leaks in the silicone covering were observed, resulting in one early shunt failure. Two attempted survival experiments were aborted due to early shunt dislodgment at 1.5 and 3.5 hours., Conclusions: Percutaneous arteriovenous shunt creation is feasible through acceptably small sheaths. Peel-away sheath placement of the stent circumvents the technical problem of placing a closed device into both artery and vein. This technique may allow percutaneous revision of existing hemodialysis access grafts and possibly de novo creation of grafts in humans, but modification of the grafts will be needed to prevent dislodgment.