Assessment of a Polyester-Covered Nitinol Stent in the Canine Aorta and Iliac Arteries

Purpose: To evaluate the patency and healing characteristics of a woven polyester fabric-covered stent in the canine model. Methods: Twenty-four self-expanding covered stents were placed in the infrarenal aorta and bilateral common iliac arteries of eight dogs and evaluated at 1 (n = 2), 3 (n = 2), and 6 (n = 4) months. Stent assessment was done using angiography prior to euthanasia, and light and scanning electron microscopy. Results: Angiographically, just prior to euthanasia, 8 of 8 aortic and 14 of 16 iliac endovascular covered stents were patent. Histologically, the stented regions showed complete endothelialization 6 months after graft implantation. A neointima had formed inside the stented vessel regions resulting in complete encasement of the fabric-covered stent by 3 months after graft implantation. Medial compression with smooth muscle cell atrophy was present in all stented regions. Explanted stent wires, examined by scanning electron microscopy, showed pitting but no cracks or breakage. Conclusion: The covered stent demonstrated predictable healing and is effective in preventing stenosis in vessels 10.0 mm or greater in diameter but does not completely preclude stenosis in vessels 6.0 mm or less in diameter.     

Self-expanding and balloon-expandable stents in the treatment of carotid aneurysms: an experimental study in a canine model.

PURPOSETo assess the efficacy of metal stents for the treatment of different forms and sizes of carotid aneurysms.METHODSA total of 14 experimentally constructed aneurysms in dogs were treated with transfemorally placed balloon-expandable tantalum and self-expanding nitinol stents.RESULTSIn 10 cases, stenting produced either immediate complete occlusion of the aneurysm (n = 7) or complete delayed thrombosis after 7 to 10 days (n = 3). In two cases treated with balloon-expandable tantalum endoprostheses, repeated angiography showed a persistent aneurysmal neck with a diameter of 1 mm. No incompletely occluded aneurysms were visible after implantation of nitinol stents. Nine-month angiographic follow-up revealed maximal stenosis of the stented vessel segment of up to 40% after placement of tantalum endoprostheses. However, no more than 15% stenosis followed the deployment of nitinol stents. Histologic examination confirmed these findings. Significantly greater intimal fibrocellular tissue growth surrounded tantalum filaments than nitinol filaments, which were covered with a smooth, thin neointimal layer. In two carotid arteries a subtotal and total occlusion of the parent vessel occurred after the insertion of a tantalum and nitinol stent, respectively. No recanalization of completely occluded aneurysms or delayed migration of a stent was observed.CONCLUSIONSPorous, tubular self-expanding nitinol stents may become the treatment of choice for broad-based and fusiform aneurysms of the internal carotid artery. However, blood flow dynamics of the aneurysms must be studied carefully in order to select an appropriate mesh size for complete occlusion while preserving the parent vessel. Improvements in the introducing system, stent material, and stent shape are required for simple implantation and reduction of intimal hyperplasia.     

Treatment of experimentally induced atherosclerosis in swine iliac arteries: A comparison of self-expanding and balloon-expanded stents

Atherosclerosis was induced in 20 Hanford miniature swine. Subsequently, one iliac artery lesion in each of 16 pigs was stented with either a self-expanding (8 pigs) or a balloon-expanded (8 pigs) stent. Immediately after stent placement, 4 animals in each group were taken off the atherogenic diet and continued on normal chow for the remainder of the study. Four months after stents were placed, atherosclerosis and the mural changes associated with the stent were more clearly evident in the arteries of the pigs continued on the atherogenic diet. These pigs also exhibited significantly more neointimal proliferation. In addition, the arteries containing the balloon-expanded stents showed more extensive and complex intimal changes when compared with arteries with self-expanding stents. Although both stent designs were equally effective in maintaining vascular patency, the balloon-expanded stent was more traumatic to the vessel wall which resulted in a significantly greater neointimal thickness.     

Late Type III endoleak and graft failure of an Ancure stent-graft

The authors report a case of a delayed type IIIb endoleak with sac expansion 6 years after an endovascular repair of an abdominal aortic aneurysm with an Ancure bifurcated stent-graft. The presumed etiology of the leak was secondary to erosion of the main body graft material by metal stents placed within the graft to correct kinking of the iliac limbs at the index operation. The endoleak was successfully treated by endovascular means with an aortouni-iliac device, contralateral iliac plug followed by a femoral-to-femoral bypass graft.     

Inhibition of neointimal proliferation with 188Re-labeled self-expanding nitinol stent in a sheep model

PURPOSE: To evaluate a self-expanding rhenium 188 (188Re) radiochemically labeled radioactive stent in sheep. MATERIALS AND METHODS: A self-expanding nitinol stent (30 mm in length, 8 mm in diameter) coated with a functionalized polymer layer was radiolabeled with 188Re. Fifty prostheses, 25 of which were radioactive (mean radioactivity, 20 MBq +/- 3.8 [SD]) and 25 of which were nonradioactive, were implanted into the external iliac arteries of 25 sheep. Stent patency was assessed with angiography. Neointimal formation was assessed with intravascular ultrasonography and histologic examination 1 month (in all sheep) and 3 months (in 12 sheep) after implantation. The results were analyzed by using repeated-measures analysis of variance with two repeated factors and paired t tests for comparison at each measuring point. RESULTS: All stents were placed successfully. Data in one animal had to be excluded from the study. After 3 months, a mean neointimal area reduction of 70 mm2 +/- 55 (SD) was observed inside the radioactive stents, and a mean lumen reduction of 126 mm2 +/- 39 was observed inside the nonradioactive control stents (P =.022). An edge effect was observed in the radioactive stents in that they showed an amount of neointimal formation at the edges that was similar to that seen in control stents. This neointimal formation accounted for the maximum lumen loss in the vascular segment with the stent. CONCLUSION: As compared with a nonradioactive stent, a beta particle-emitting stent, through endovascular irradiation, significantly inhibits neointimal formation inside the stent but not at the stent edges.     

Oversizing of self-expanding stents: influence on the development of neointimal hyperplasia of the carotid artery in a canine model

BACKGROUND AND PURPOSE: In carotid artery stent placement, marked oversizing of the stent relative to the internal carotid artery lumen is common. This study was performed to determine the influence of using oversized self-expanding nitinol stents on neointimal hyperplasia. METHODS: In six greyhound dogs, 24 self-expanding nitinol stents (eight SMART stents, eight Easy Wallstents, eight Sinus-Flex stents) were inserted into both common carotid arteries (CCAs). In each CCA, two stents were deployed; a stent of the appropriate diameter was implanted distally and an oversized stent proximally. After 4 months, transverse sections of each stent were examined histologically and at computerized image analysis. Neointimal hyperplasia was determined as the proportion of the residual diameter of the patent vessel lumen compared with the stent lumen. RESULTS: The amount of neointimal hyperplasia did not differ between the normal-sized and oversized stents. The mean preserved luminal diameter (+/-SEM) with normal- and oversized stents, respectively, were as follows: Easy Wallstent, 94% +/- 1.0 and 96% +/- 1.5; SMART stent, 92% +/- 1.6 and 93% +/- 1.8; and Sinus-Flex stent, 93% +/- 2.7 and 93% +/- 2.6. The mean preserved patent lumen with the 12 normal-sized stents (93% +/-1.0) was not significantly different from that of the 12 oversized stents (94% +/- 1.1, P =.502). CONCLUSION: Under experimental conditions, use of self-expanding stents oversized by 30-40% appeared to result in neointimal hyperplasia comparable to that caused by normal-sized stents. All three stent types appeared to have similarly low neointimal responses.     

Self-expanding metallic stents: preliminary evaluation in an atherosclerotic model

The performance of the self-expanding stainless steel (Gianturco) stent in atherosclerotic arteries was examined in a rabbit model. Atherosclerosis was induced by supplementing rabbit chow with 6% peanut oil and 2% cholesterol followed by endothelial disruption of the abdominal aorta with a balloon catheter and continuation on the atherogenic diet for the remainder of the study. Eighteen stents, 1 cm in length and 4 or 5 mm in diameter when fully expanded, were placed in atherosclerotic stenotic lesions in six rabbits. Luminal distention was consistently achieved. At 8 weeks follow-up, no luminal narrowing, stent migration, thrombus formation or branch vessel occlusion had occurred. Atherosclerotic neointimal proliferation occurred around the stent wires following placement, but did not cause significant luminal narrowing.     

A new device for transcatheter closure of the patent ductus arteriosus. A feasibility study in dogs

A new device for transcatheter closure of the patent ductus arteriosus was developed and initially evaluated in the vasculature of adult mongrel dogs. The device consists of a nylon sack that can be made in various sizes and shapes. A small flexible crossbar attached to the distal end maintains the position of the sack while it is filled with a segment of modified guide wire. The device is delivered coaxially through a 10-Fr Teflon catheter and is easily repositioned or retrieved before release. The expansile force of the sack against the vessel wall can be varied, and its stability is easily checked prior to detachment. The device produced immediate and permanent vascular occlusion without inflammation or erosion. Over time, the entire unit became incorporated into the vessel wall by neointimal encasement. Nylon sacks offer a simple, unique method of closing virtually any ductus arteriosus without general anesthesia and major surgery.     

Multislice CT Angiography of Fenestrated Endovascular Stent Grafting for Treating Abdominal Aortic Aneurysms: a Pictorial Review of the 2D/3D Visualizations

Fenestrated endovascular repair of an abdominal aortic aneurysm has been developed to treat patients with a short or complicated aneurysm neck. Fenestration involves creating an opening in the graft fabric to accommodate the orifice of the vessel that is targeted for preservation. Fixation of the fenestration to the renal arteries and the other visceral arteries can be done by implanting bare or covered stents across the graft-artery ostia interfaces so that a portion of the stent protrudes into the aortic lumen. Accurate alignment of the targeted vessels in a longitudinal aspect is hard to achieve during stent deployment because rotation of the stent graft may take place during delivery from the sheath. Understanding the 3D relationship of the aortic branches and the fenestrated vessel stents following fenestration will aid endovascular specialists to evaluate how the stent graft is situated within the aorta after placement of fenestrations. The aim of this article is to provide the 2D and 3D imaging appearances of the fenestrated endovascular grafts that were implanted in a group of patients with abdominal aortic aneurysms, based on the multislice CT angiography. The potential applications of each visualization technique were explored and compared with the 2D axial images.     

A novel self-expanding fully retrievable intracranial stent (SOLO): experience in nine procedures of stent-assisted aneurysm coil occlusion

Introduction The endovascular treatment of large and broad-necked aneurysms may require the use of a remodelling balloon or a stent system to achieve proper occlusion while maintaining the patency of the parent vessel. With the advent of self-expanding stents that can be delivered through a microcatheter, this kind of treatment has improved and problems with the previously used balloon expandable stents have largely been overcome. However, rigidity, insufficient trackability, and limited or non-existent retrievability may still restrict the application of self-expanding stents in some situations. Methods Recently, a stent system with a new and different design has been introduced. This stent is highly flexible, fully retrievable, and can be delivered through a standard 0.021-inch microcatheter without a wire. We describe the first nine cases of stent-assisted coil occlusion of intracranial aneurysms with the use of this stent system. Between May and June of 2004, nine patients with large or broad-necked aneurysms were treated in two endovascular centres. The anatomy of the aneurysms and parent vessels, technical details of the procedure, performance of the stent system, and follow-up results were evaluated. Results In all procedures, the SOLO stent could be introduced without difficulty, in one procedure after positioning of a different self-expanding stent system had failed due to vessel tortuosity. Overlapping stents were placed in one patient and stent retrieval or repositioning was successfully performed in two procedures. There was no interference or limitation of subsequent coil occlusion after stenting. With regard to the stent, immediate postprocedure and follow-up angiograms were unremarkable in terms of thromboembolic events and signs of intimal hyperplasia. Conclusion From our experience, we conclude that the SOLO stent shows satisfactory performance overall. Its unique design gives the stent properties that may help overcome some of the difficulties experienced with other self-expanding intracranial stent systems.     

Expandable intraluminal graft: a preliminary study. Work in progress

To overcome the problem of recurrence of stenosis after vascular balloon dilatations, we developed an expandable, intraluminal graft that allows dilatation of the lesion and simultaneous placement of a supportive endoprosthesis to prevent recoil of the arterial wall. The graft is made of continuous, woven, stainless steel wire. The resulting tubular mesh has a wall thickness of 200-450 micron and 80% open surface. The grafts, mounted on angioplasty catheters, are introduced through 8-12-F Teflon sheaths. Eleven grafts of 6, 8, and 10 mm in diameter by 20 mm long were placed in the aorta, common carotid, superior mesenteric, iliac, and renal arteries of dogs. Six grafts showed no stenosis in follow-up studies of up to 8 weeks. Two grafts had moderate stenosis as a result of neointimal hyperplasia. Two partial and one complete graft thrombosis occurred in nonheparinized animals in which the graft outflow was restricted. Anticoagulant was not used on a long-term basis. Light and electron microscopy studies showed complete covering of the graft's inner surface by endothelium at 3 weeks.     

Optimal Covering Material for Stent-Grafts Placed in the Portal Vein in a Canine Model

Purpose We evaluated the suitability of Dacron, polytetrafluoroethylene (PTFE), and small intestinal submucosa (SIS) as a covering material for stent-grafts placed in the portal vein as compared with a bare stent. Methods Using 24 beagle dogs, either bare stents or stent-grafts covered with Dacron, PTFE, or SIS were placed in the main trunk of the portal vein in 6 animals each. Portography was performed immediately after stent placement, and at 2, 4, and 12 weeks thereafter. Next, the extracted stents or stent-grafts were examined histopathologically. Neointimal thickness adjacent to the stent wire and at the midportion between the stent wires was compared among the groups. Then, the neointimal thickness at the sub- and supragraft sites was compared between each stent-graft group. Serial changes in the histologic features of the thickened neointima were also investigated. Results No significant difference was noted in the mean stenotic ratio of the portal vein diameter between the bare stent and PTFE groups, whereas it was significantly higher in the Dacron and SIS groups compared with the bare stent group. In neither of the studies on neointimal thickness adjacent to the stent wire and at the midportion between the stent wires were any significant differences noted between the neointimal thickness of the bare stent group and the sum of the neointimal thickness of the PTFE group, whereas the sum of the neointimal thickness of the Dacron and SIS groups was significantly greater than that of the bare stent group at both sites. In the comparison of the supragraft neointimal thickness, the SIS group showed significantly greater thickness than the PTFE group, while the difference between the Dacron and PTFE groups was not significant. In the comparison of the subgraft neointimal thickness, the Dacron and SIS groups showed significantly greater thickness than the PTFE group. Conclusion The present results indicate that of the three covering materials examined here, PTFE is the most suitable material for grafts placed in the portal vein.     

Self-expandable macroporous nitinol stents for transfemoral exclusion of aortic aneurysms in dogs: Preliminary results

This experimental study evaluated the feasibility of excluding artificially created aortic aneurysms in dogs with transfemorally inserted nitinol stents, serving as intraluminal bypass. Infrarenal aortic aneurysms were created in eleven dogs (28–35 kg) by end-to-end anastomosis of sacciform conduits. Single and double wire-knitted, macroporous, superelastic, self-expanding nitinol stents without any additional wrapping or in-between fabrics served as endovascular grafts. The pore size of the double-knitted stents was less than 0.7 mm². Angiography following stent placement showed immediate exclusion of the aneurysms for the double-knitted stents. For the single-knitted stents (2 cases), partial exclusion was achieved only after considerable delay. CT studies in the dogs with the double-knitted stents revealed patency of the grafts after 3 to 5 weeks with the aneurysms totally thrombosed. So far gross pathology of 1 dog at 24 h and 1 at 12 months revealed patency of the stents. At 12 months histopathology showed a neointima covering the inner stent surface with the aneurysm filled by an organized thrombus. It is concluded, that an “open” stent with a tight meshwork appears to be a suitable device to instantly exclude artificial aneurysms of the canine aorta.     

Percutaneous endovascular stents: an experimental evaluation

Percutaneous, expanding, endovascular stents were constructed of stainless steel wire formed in a zig-zag pattern. Stents were placed for varying periods of time in the jugular vein, vena cava, and abdominal aorta in each of five adult dogs. The dilating force of the stents could be controlled by different wire size, number and angle of wire bends, and stent length. In addition, multiple stents could be placed one inside the other or one after the other, depending on the circumstance. The stents distended the vessels and increased their diameter. No flow defects, luminal narrowing, or occlusion were noted in any of the stented vessels, even after 6 months. Side branches bridged by the stents remained patent and showed no indication of narrowing. Stent wires became encased by a proliferation of the tunica intima where they contacted the vessel wall. Encasement was slower and less extensive in the abdominal aorta. No vascular erosion or clot formation was found to be associated with any of the stents.     

Neue Stententwicklungen für die periphere arterielle Verschlusskrankheit

Infrainguinal peripheral occlusive disease is increasingly being treated by endovascular techniques. Bare metal stainless steel, self-expanding nitinol stents, drug-eluting and covered stents (stent grafts) are becoming increasingly more important adjuncts to percutaneous translumninal angioplasty in the treatment of peripheral artery disease. In this article the available evidence supporting the use of stents in the femoropopliteal and tibial arteries will be described as well as their limitations. Future stent developments will also be discussed.     

Stent-Based Nitric Oxide Delivery Reducing Neointimal Proliferation in a Porcine Carotid Overstretch Injury Model

BACKGROUND: The effects of nitric acid (NO) on vessel response to injury include the inhibition of platelet adhesion, platelet aggregation, leukocyte adhesion and smooth muscle cell proliferation. Releasing NO from a stent might reduce the clinical problem of restenosis. The present study was designed to examine whether an NO-eluting covered stent can prevent neointimal formation in a porcine carotid overstretch injury model. METHODS: The interior of a self-expanding polytetrafluoroethylene (ePTFE)-covered aSpire stent was coated with silicone, which contained 23.6 microg or 54.5 microg sodium nitroprusside (SNP, NO-releasing compound). The stent was implanted into carotid artery. Six pigs were implanted with stents, one high-dose SNP and one uncoated control, following balloon overstretch injury of the carotid artery with a balloon-to-artery ratio of 1.3:1. RESULTS: No local or systemic toxicity was evidenced in the six pigs after carotid artery implantation with either low- or high-dose stents within a week. At day 28, the mean intimal thickness was 0.12 +/- 0.05 mm for NO-eluting stents and 0.43 +/- 0.09 mm for uncoated stents (p = 0.008). The mean neointimal area was reduced from 2.40 +/- 0.39 mm2 for control stents to 0.49 +/- 0.16 mm2 for NO-eluting stents (p < 0.0001), which resulted in a 24% reduction of angiographic vessel narrowing. CONCLUSIONS: The NO-eluting ePTFE-covered stent is feasible and effectively reduces in-stent neointimal hyperplasia at 28 days in a porcine carotid overstretch model.     

Occlusion of experimentally created fusiform aneurysms with porous metallic stents

BACKGROUND AND PURPOSE: Carotid fusiform aneurysms are most commonly treated with occlusion of the parent vessel. The purpose of our study was to assess the effectiveness of self-expanding, cobalt-alloy stents in the ablation of experimental fusiform aneurysms with preservation of the parent vessel in a carotid artery model. METHODS: Porous metallic stents were placed endovascularly along the lengths of experimentally created fusiform aneurysms in the carotid arteries of dogs; aneurysms were also created in the animals' opposite carotid arteries to serve as controls. RESULTS: Before stent placement, angiography of the carotid arteries showed large fusiform aneurysms along the lengths of the common carotid arteries and complex patterns of flow. Immediately after stent placement there was disruption of the usual flow patterns within the lumens of the fusiform aneurysms. The lumen between the wall of the aneurysm and stented carotid showed stasis of contrast material and blood. Near-complete ablation of all aneurysms was observed 8 weeks after stent placement. The stented carotid arteries remained widely patent; control aneurysms and carotid arteries were patent and unchanged. Histopathologic analysis revealed fibrotic reactive scar tissue filling the space between the stent wires and outer wall of the fusiform aneurysm. CONCLUSION: Changing blood flow dynamics within an aneurysm can promote thrombus formation. The stent promotes stasis and thrombus within the residual lumen between the stent wall and the outer wall of the aneurysm because its woven wire mesh interferes with usual blood flow patterns, which then promotes formation of thrombus and fibrosis within the residual aneurysmal lumen.     

Occlusive effect of metallic stents on canine ureters

A three-part study, with successive modifications based on preceding results, was conducted to evaluate ureteral placement of metallic stents. Gianturco self-expanding (10 mm and 4 mm diameter) and balloon-expanded (4 mm diameter) metallic stents were placed in normal and stenotic canine ureters. No migration or ureteral perforation occurred during the follow-up of 10 mm stents. Varying degrees of hydronephrosis and hydroureter were found on all 1-week pyelograms. At 4 weeks, complete occlusion of the stented ureter was noted in all cases because of mucosal hyperplasia around the stent wires. To prevent this reaction, 4 mm self-expanding stents constructed of smaller wire that was uncoated or coated with either Teflon or polyurethane were tested in five dogs. In all cases, results were similar to those obtained with the larger prostheses. Finally, 4 mm balloon-expanded stents were placed in a normal ureter of three dogs. In one dog, the stent migrated out of the ureter. No migration or ureteral perforation occurred in the two remaining dogs. In these animals, mucosal hyperplasia and complete ureteral occlusion occurred 6 and 8 weeks after placement. Therefore, ureteral placement of Gianturco self-expanding as well as balloon-expanded metallic stents leads to occlusion of the ureter instead of maintaining its patency. Stents, therefore, may be useful as ureteral occlusion devices.     

Self-expanding metallic stents for small vessels: an experimental evaluation

Thirty-three self-expanding metallic stents were placed in 24 arterial segments of the hind legs and nine arteries of the abdominal viscera in seven dogs. Twelve 5-mm stents, eight 4-mm stents, and 13 3-mm stents were inserted. Follow-up ranged from 4 to 30 weeks. All 4-mm and 5-mm stents were patent at follow-up. Seven (54%) of the 3-mm stents remained patent. Stent wires were completely covered by a proliferation of the intima. No stent migration, occlusion of side branches, or vessel wall perforation was observed. A stent/artery ratio (SAR) was computed using stent and recipient vessel diameters. Good vascular patency was observed when the SAR was less than or equal to 1.2. An SAR greater than 1.2 was associated with immediate spasm, immediate or delayed thrombosis, or excessive intimal proliferation. Selection of correct stent size is a major determinant of patency in small arteries.     

Utilization of self-expanding stents in the treatment of intracranial atherosclerotic disease in the distal small cerebral vessels

Introduction Previously, endovascular treatment of stenosis related to intracranial atherosclerosis (ICAD) involving arteries measuring less than 2 mm in diameter was limited. To our knowledge, there are no reports in the literature addressing stent placement for treatment of stenosis in arteries of this size. Methods Four patients aged 33 to 80 years (mean 57.5 years) with medically refractory ICAD underwent angioplasty and stenting of small (<2 mm) distal intracerebral arteries. Vessel location and length of follow-up were anterior cerebral artery (ACA) A1 segment (5 months), ACA A2 segment (18 months), middle cerebral artery M1 segment (18 months), and posterior cerebral artery P1 segment (8 months) with vessel calibers ranging from 1.2 to 1.8 mm. Clinical and imaging follow-up ranged from 5 to 18 months. Results All procedures were successfully performed without complications. Follow-up out to 18 months demonstrated one vessel that went on to occlusion while the other stented vessel segments remained patent. One patient died 8 months after stenting, but the death was not related to neurological disease. The remaining patients experienced resolution of the presenting symptomatology and remained asymptomatic throughout follow-up. Conclusion In this small series, stenoses of distal (<2 mm) cerebral arteries were amenable to treatment using new self-expanding stents. We safely and successfully treated four arteries smaller than 2 mm in diameter with newer self-expanding stents. All patients remained clinically asymptomatic. One stent occluded at 5 months and the others remained patent during follow-up. Longer term clinical follow-up is required to determine the durability and viability of this therapy.