Treatment of complex arteriosclerotic lesions with nitinol stents in the superficial femoral and popliteal arteries: a midterm follow-up.

PURPOSE: To evaluate the effectiveness of nitinol stents in patients with short, complex lesions in the superficial femoral and popliteal arteries and to assess midterm results. MATERIALS AND METHODS: Self-expandable nitinol stents were implanted in 54 extremities in 44 patients to treat complex stenoses (n = 32) and occlusions (n = 22) in the superficial femoral and popliteal arteries. Follow-up was performed for 5-51 months to evaluate early thrombosis and midterm patency rates. Midterm patency rates were compared between the following: stenoses and occlusions, proximal and distal locations, good and poor runoff, and diabetic patients and nondiabetic patients. All patients underwent clinical investigation and color Doppler sonography after 1 month and 6 months and at 6-month intervals thereafter. If restenosis or stent thrombosis was suspected, intraarterial digital subtraction angiography of the superficial and popliteal arteries was performed. RESULTS: Percutaneous stent implantation was successful in all patients. The mean duration of follow-up was 27 months (range, 5-51 months). No thrombotic occlusion occurred within the first 4 weeks after stent implantation. The primary 3-year patency rate was 76%, and the secondary patency rate was 87%. Three-year primary patency rates were 65% for diabetic patients and 82% for nondiabetic patients. CONCLUSION: In patients with short, complex stenoses and occlusions, implantation of nitinol stents may have a positive impact on midterm results.     

国产硅酮覆膜支架血液相容性的实验研究

目的评价国产硅酮覆膜支架在犬髂动脉内的血液相容性。方法实验犬9只。18条正常髂动脉,先行大球囊经皮腔内血管成形术(PTA)术后置人支架,继而置人硅酮覆膜支架10枚和镍钛合金编织型裸支架8枚(对照组)。术后第1、4、12周,两组分别抽取一定数量支架段血管行DSA观察通畅率和支架内再狭窄程度;其后处死动物,取出支架段血管,作苏木精-伊红染色及组织学检查,并对两组支架急性血栓形成情况、支架的内膜覆盖和新生内膜增生程度等作出评价。结果术后第1、4、12周DSA所见：①裸支架组各段时间造影均显示通畅,12周时支架段血管狭窄平均为36．7％;②硅酮膜支架组有2支血管闭塞(通畅率为80％),12周时支架段血管狭窄平均为72．3％。结论本组实验用国产硅酮膜支架的血液相容性不优于裸支架。     

Effects of nitinol Strecker stent placement on vascular response in normal and stenotic porcine iliac arteries

PURPOSE: This experimental study was conducted to evaluate neointimal thickness, lumen diameters, and histologic changes in normal and stenotic porcine iliac arteries following placement of self-expanding nitinol Strecker stents. MATERIALS AND METHODS: Neointimal trauma causing slight vascular stenosis was induced unilaterally within external iliac arteries of 12 swines by means of endothelial abrasion and high cholesterol diet. Nitinol Strecker stents were placed within the stenotic and the normal contralateral vascular segments. For histopathologic evaluation, the pigs were killed 12 or 24 weeks after stent placement and luminal diamters were evaluated angiographically. RESULTS: Excluding one occlusion, 15% narrowing of the lumen diameter was induced unilaterally (P = .002). Initial luminal gain after stent placement was greater for stenotic than for normal arteries. The amount of neointima thickness was not different between stenotic and normal vessels (P > .05). Comparing vascular diameters before stent placement and at follow-up, luminal loss due to neointima proliferation was 22% within normal arteries (P = .0002), while a luminal gain by 15% was found within the stenotic arteries (P = .008). Maturation of neointima and endothelial coverage were complete after 24 weeks. CONCLUSIONS: Even though nitinol Strecker stents induce excessive neointimal proliferation, stenotic arteries seem to profit from great early luminal gain resulting in 15% of vascular expansion at follow-up while slight stenosis is induced within normal iliac arteries.     

Placement of Endovascular Stent across the Branching Arteries: Long-term Serial Evaluation of Stent-tissue Responses Overlying the Arterial Orifices in an Experimental Study

Purpose

This study was designed to investigate the effects of stenting across the branching arteries on the patency and stent-tissue responses over the branching arterial orifices.

Methods

Thirteen dogs were observed after placing aortic stents across the celiac arteries (CA), superior mesenteric arteries (SMA), and renal arteries (RA). The animals were grouped according to stent types: large-cell group (n?=?6) and small-cell group (n?=?7). Angiography was performed to evaluate the branching artery patency at 2, 6, and 12?months after stent insertion, and the stent-tissue responses covering the orifices were evaluated on histopathologic examination.

Results

All branching arteries were patent on follow-up angiography; however, three patterns of stent-tissue responses over the orifices were observed: neointimal layering, bridging septa, and papillary hyperplasia. Although neointimal layering and bridging septa were evenly observed, severe papillary hyperplasia was more frequent at SMA and CA than RA. Four RA showed less than 50% ostial patency, and localized infarct was observed in six kidneys (24%). The ostial patency tended to decrease with small-cell stent during the follow-up period.

Conclusions

Various stent-tissue responses over the branching artery orifices are induced by the aortic stent covering the branching arteries and may not be easily detected by conventional angiography. Subclinical renal infarct also may occur despite patent renal angiography.     

Comparison of diamond-like carbon-coated nitinol stents with or without polyethylene glycol grafting and uncoated nitinol stents in a canine iliac artery model

Objective

Neointimal hyperplasia is a major complication of endovascular stent placement with consequent in-stent restenosis or occlusion. Improvements in the biocompatibility of stent designs could reduce stent-associated thrombosis and in-stent restenosis. We hypothesised that the use of a diamond-like carbon (DLC)-coated nitinol stent or a polyethylene glycol (PEG)-DLC-coated nitinol stent could reduce the formation of neointimal hyperplasia, thereby improving stent patency with improved biocompatibility.

Methods

A total of 24 stents were implanted, under general anaesthesia, into the iliac arteries of six dogs (four stents in each dog) using the carotid artery approach. The experimental study dogs were divided into three groups: the uncoated nitinol stent group (n = 8), the DLC-nitinol stent group (n = 8) and the PEG-DLC-nitinol stent group (n = 8).

Results

The mean percentage of neointimal hyperplasia was significantly less in the DLC-nitinol stent group (26.7±7.6%) than in the nitinol stent group (40.0±20.3%) (p = 0.021). However, the mean percentage of neointimal hyperplasia was significantly greater in the PEG-DLC-nitinol stent group (58.7±24.7%) than in the nitinol stent group (40.0±20.3%) (p = 0.01).

Conclusion

Our findings indicate that DLC-coated nitinol stents might induce less neointimal hyperplasia than conventional nitinol stents following implantation in a canine iliac artery model; however, the DLC-coated nitinol stent surface when reformed with PEG induces more neointimal hyperplasia than either a conventional or DLC-coated nitinol stent.     

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.     

Initial clinical experience with the 4-F self-expanding XPERT stent system for infrapopliteal treatment of patients with severe claudication and critical limb ischemia

PURPOSE: To evaluate the primary success and short-term patency associated with a new 4-F sheath-compatible self-expanding nitinol stent after failed conventional angioplasty of distal popliteal and infrapopliteal lesions in severe lifestyle-limiting claudication (LLC) and chronic critical limb ischemia (CLI). MATERIALS AND METHODS: Between May 2003 and July 2005, 35 patients with Rutherford category 3-5 disease (16 patients with CLI, 19 patients with LLC) underwent percutaneous transluminal angioplasty (PTA) and stent implantation. Indications for stent placement were residual stenosis, flow-limiting dissections, or elastic recoil after PTA. Before and after the intervention and during the 6-month follow-up, clinical investigation, color-flow and duplex Doppler ultrasonography, and digital subtraction angiography were performed. Technical success, primary patency at 6 months, clinical improvement as defined by Rutherford with clinical and hemodynamic measures, and complications were evaluated. RESULTS: A total of 22 patients underwent distal popliteal artery stent placement and 13 underwent tibioperoneal artery stent placement. Stent implantation was successfully performed in all patients. After stent placement, the primary cumulative patency rate for the study group at 6 months was 82%. The mean resting ankle-brachial index at baseline was 0.50 +/- 0.16 and significantly increased to 0.90 +/- 0.17 at 12-24 hours after intervention and 0.82 +/- 0.24 at latest follow-up (P < .001 for both). The sustained clinical improvement rate was 80% at the 6-month follow-up. The 6-month limb salvage rate regarding major amputation was 100%. The rate of major complications was 17%. CONCLUSIONS: Infrapopliteal application of the new nitinol stent is a safe, feasible, and effective method with good short-term patency rate in the treatment of severe LLC and chronic CLI.     

Primary patency of femoropopliteal arteries treated with nitinol versus stainless steel self-expanding stents: propensity score-adjusted analysis

PURPOSE: To evaluate, in a propensity score-adjusted analysis, the intermediate-term primary patency rates associated with nitinol versus stainless steel self-expanding stent placement for treatment of atherosclerotic lesions in femoropopliteal arteries. MATERIALS AND METHODS: The authors analyzed the clinical and imaging data of 175 consecutive patients with peripheral artery disease and either intermittent claudication (n = 150) or critical limb ischemia (n = 25) who underwent femoropopliteal artery implantation of nitinol (n = 104) or stainless steel (n = 123) stents in a nonrandomized setting. The stents were placed owing to either significant residual stenosis (ie, >30% lumen diameter reduction) or flow-limiting dissection after initial balloon angioplasty of the femoropopliteal artery. Patients were followed up for a median period of 9 months (mean, 13 months; range, 6-66 months) for the detection of a first in-stent restenosis, defined as a greater than 50% lumen diameter reduction that was seen at color-coded duplex ultrasonography and confirmed at angiography. RESULTS: Cumulative patency rates at 6, 12, and 24 months were 85%, 75%, and 69%, respectively, after nitinol stent placement versus 78%, 54%, and 34%, respectively, after stainless steel stent placement (P =.008, log-rank test). There were no statistically significant differences in associated patency among the three different nitinol stents used (P =.72, log-rank test). Multivariate Cox proportional hazard analysis, in which the effect of propensity to receive a nitinol stent was considered, revealed a significantly reduced risk of restenosis with the nitinol stents compared with the risk of restenosis with the stainless steel stents (adjusted hazard ratio, 0.44; 95% confidence interval: 0.22, 0.85; P =.014). CONCLUSION: Nitinol stents are associated with significantly improved primary patency rates in femoropopliteal arteries compared with stainless steel stents. Randomized controlled trials are needed to confirm these results.     

Carotid Artery Stenting Using a Novel Self-Expanding Braided Nickel–Titanium Stent: Feasibility and Safety Porcine Trial

We studied the deliverability and safety of a braided, self-expanding, closed-cell nickel–titanium (NiTi) stent (E-volution, Jotec GmbH, Hechingen, Germany) especially designed for the endovascular treatment of carotid artery bifurcation stenosis with special regard to in-stent stenosis and thrombosis compared with a laser-cut reference nitinol stent in a porcine model of percutaneous vascular interventions. We aimed to assess histopathologic response in minipig carotid and subclavian arteries. Eight minipigs received a total of 42 stents: 14 reference stents and 28 E-volution stents. Eleven of the E-volution stents were additionally coated with heparin. Control angiography was obtained immediately before and after vascular intervention as well as 4 weeks after the procedure. Primary endpoints were 28 days of angiographic analyses as well as histomorphometric analysis, including injury score, inflammation score, luminal diameter, vessel diameter, maximal neointimal thickness, and area of in-stent stenosis. Secondary end points were procedural success, 28-day mortality, and stent thrombosis. All stents could be delivered successfully without procedural complications, morbidity, or mortality during our observation time. As confirmed by histology, no in-stent thrombosis was observed. Compared with common carotid arteries, subclavian arteries are significantly more vulnerable to developing in-stent stenosis caused by neointima proliferation (p < 0.05). Compared with the use of 1 single stent/artery, serial application of two stents leads to a more excessive but not significantly different neointimal proliferation (p > 0.05). The E-volution stent, especially when heparin coated, is in line with the comparison to the laser-cut reference stent displaying similar results of angiographic, histologic, and histomorphometric analyses (p > 0.05). Compared with the reference laser-cut stent, the self-expanding nitinol stent (E-volution) with its advanced braiding technology is feasible and safe. In our opinion, the high radial resistive force and the advanced braided design with tight stent-strut interstices may be beneficial in terms of plaque stabilization. Further studies are necessary and warranted.     

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.     

Puncture of stents implanted into veins and arteriovenous fistulas: An Experimental Study

Purpose Puncture of venous Wallstents and nitinol stents with dialysis needles was tested in an animal study.Methods In 15 sheep, divided into a group with prior surgical unilateral carotid-jugular shunt creation (9 sheep) and a second group without shunt creation (6 sheep), a self-expanding nitinol stent and/or a Wallstent were bilaterally placed into the jugular veins. After 1 month, 10 nitinol stents and 9 Wallstents were punctured weekly with a 15-gauge cannula over a period of 15 weeks. Stent patency was followed up by colorcoded duplex ultrasound and angiography. After sacrifice, high resolution X-rays of the removed vessels were taken to assess stent deformation. From histological slices, neointimal thickness inside the stents was measured and analyzed statistically.Results Puncturing of both the nitinol stent and the Wallstent was technically feasible. Stent deformations were not found. One stent stenosis, probably related to puncture, was observed. The pattern of intimal hyperplasia differed between the nitinol stent and the Wallstent. Outward bulge of the vascular layers over the stent struts was greater in nitinol stents. In the relevant area in between the stent struts there was no significant difference in intimal thickness between the two types of stents. Intimal thickness was more pronounced in shunted than in nonshunted animals only in the Wallstent subgroup (p = 0.025) and more pronounced in punctured than in nonpunctured stents only in the nitinol stent subgroup (p = 0.018).Conclusion Puncturing of stents was feasible without major short-term complications. Therefore, stent implantation into the punctured segment of a hemodialysis fistula may be indicated if there is no alternative treatment.     

A new stent designed for carotid artery application. An experimental study

PURPOSE: To evaluate a new stent developed for treating arterial stenoses located adjacent to the bifurcation of the carotid artery. MATERIAL AND METHODS: Eight 4-cm-long nitinol stents, each with a diameter of 6 mm in its distal half and 9 mm in its proximal half, were tested in 4 pigs. In each animal, the abdominal aorta was catheterized through the left common carotid artery, and 2 stents were inserted into the right and left iliac arteries, respectively, with the wider portion in the common iliac artery and the narrower portion in the corresponding external iliac artery. The pigs were killed after 24 hours, or 1, 4 or 8 weeks, following control angiography. The arteries were examined macroscopically and by scanning electron microscopy. RESULTS: All stents remained in the intended position, fitting the arterial wall, following successive expansion to their maximum diameter and after 4 weeks were completely covered by endothelium. The arteries remained patent, with preserved flow to the side branches through the stent mesh. A small thrombus was found in I artery CONCLUSION: In animal experiments, the new stent was safely inserted over the arterial bifurcation, remained in place and was covered by endothelium while flow through side branches was preserved.     

Self-expanding nitinol stents for treatment of infragenicular arteries following unsuccessful balloon angioplasty

The feasibility of self-expanding nitinol stents for treatment of infragenicular arteries following unsuccessful balloon angioplasty was assessed. Options for lower limb percutaneous revascularization are limited, especially for complex vessel obstruction. Depending on the lesion and the experience of the interventionalist, the failure rate of balloon angioplasty (PTA) ranges between 10 and 40%. Until recently, no self-expanding stent for the use in the infragenicular arteries was available. This is the first report of the results for 18 consecutive patients who received 4F sheath compatible self-expanding nitinol stents following unsuccessful PTA or early restenosis. Twenty-four stents were implanted in 21 lesions for various indications residual stenosis >50% due to heavy calcification, flow-limiting dissection, occluding thrombus resistant to thrombolyis, thrombaspiration, and PTA, and early restenosis after previous PTA. Stent implantation was feasible in all cases. No complications occurred. After the stent implantation, all primarily unsuccessful interventions could be transformed into successful procedures with no residual stenosis >30% in any case. After 6 ± 2 months, two of the 18 patients died, and 14 of the 16 remaining patients improved clinically. At follow-up, the patency could be assessed in 14 stented arteries. Three stents were occluded, one stent showed some neointimal hyperplasia (50–70% restenosis), the remaining ten stents showed no restenosis (0–30%). The use of self-expanding nitinol stents in tibioperoneal and popliteal arteries is a safe and feasible option for the treatment of unsuccessful PTA. The 6-months patency is high.     

Iliofemoral arterial occlusive disease: contrast-enhanced MR angiography for preinterventional evaluation and follow-up after stent placement.

PURPOSE: To evaluate the efficacy of contrast material-enhanced magnetic resonance (MR) angiography for the diagnosis of peripheral arterial occlusion and follow-up after stent placement. MATERIALS AND METHODS: Sixty-seven patients (21 women, 46 men; mean age, 64.6 years) were examined. Digital subtraction angiography and contrast-enhanced MR angiography were performed in 28 patients for preinterventional evaluation of iliofemoral arterial occlusion and in 39 patients for follow-up after stent placement in the iliac or femoral arteries, which had been performed several months before. RESULTS: All 24 occlusions were correctly diagnosed with contrast-enhanced MR angiography. Of the 59 stenoses, 36 were greater than 50% and 23 were 50% or less. Sensitivity and specificity for the detection of stenoses greater than 50% were 100% and 83%, respectively. Patency of the different stents was determined correctly with contrast-enhanced MR angiography. Some stents caused signal intensity dropout, which made MR evaluation of stents difficult. Generally, these signal intensity artifacts were most severe in stainless steel stents and mild in some nitinol stents. CONCLUSION: Contrast-enhanced MR angiography is comparable to digital subtraction angiography for the detection of stenosis greater than 50% and occlusion in the iliofemoral arteries. Stent patency can be determined, but contrast-enhanced MR angiography is not suitable for stent evaluation owing to signal intensity dropout; however, it provides information about the vascular anatomic areas proximal and distal to the stent.     

Treatment of wide-necked intracranial aneurysms with a novel self-expanding two-zonal endovascular stent device

Introduction Endovascular treatment of intracerebral wide-necked aneurysms carries the risk of incomplete embolisation and recanalisation of the aneurysm as well as coil protrusion into the parent artery and embolic complications. We present preliminary results with the placement of a novel tightly braided stent across the aneurysm neck which might lead to thrombosis of these aneurysms. Methods A bifurcation artery aneurysm was created in a male New Zealand White Rabbit. After 4 weeks, a novel highly flexible stent with a central tightly braided mesh was placed across the aneurysm neck. Diagnostic angiography was performed during the procedure and immediately after stent deployment as well as 2 and 4 weeks following stent placement. Histological analyses, including microscopic investigations for evaluating intra-aneurysmal thrombosis and proliferation of the intima, were performed after 1 month. Results Intra-aneurysmal flow reduction due to stent placement was achieved as early as 45 min after deployment. Unchanged complete occlusion of the aneurysm could be observed by angiography 2 and 4 weeks post-stent deployment. Histological analysis confirmed angiographical findings of complete aneurysm occlusion and excluded significant neointimal coverage. Conclusion This newly designed flexible stent may offer the potential to expand endovascular treatment of wide-necked intracranial aneurysms.     

4 years' experience with a balloon-expandable endoprosthesis. Experimental and clinical application]

During a 4-year period of clinical application of the balloon-expandable Palmaz stent, a randomized trial comparing stent implantation and traditional balloon angioplasty of iliac arteries in arterial occlusive disease was started. The first long-term results, recorded after 2 years, indicate statistically significant differences in the complication rate (after stenting 2/62 and after angioplasty 5/69) and patency (greater than or equal to 70% of original lumen size upon stent implantation or balloon inflation: 95% after stenting and 72% after angioplasty). Clinical improvement after 2 years was 89% after stenting and 70% after angioplasty. Parallel to the clinical trials, experimental canine artery stenting was performed to evaluate differences in the long-term patency of stents exposed to restricted flow. Significant differences in neointimal healing were found between normally perfused stents and stents with artificially reduced flow: during the total observation period of 6 months the neointimal height was up to 200% higher in flow-restricted stents, while the histological composition of the neointima was the same as with normally perfused stents.     

Self-expanding nitinol stents in canine vertebral arteries: hemodynamics and tissue response.

PURPOSETo evaluate the hemodynamics and tissue response associated with stent placement in low-flow-velocity arteries.METHODSSix self-expanding nitinol stents (5.5 mm caliber) were implanted transfemorally within the proximal segments of vertebral arteries (2.5 mm diameter) in six adult dogs during anticoagulative protection.RESULTSControl angiograms demonstrated patency and 20% dilatation of all stented arteries. One artery was partially thrombosed 1 week later and subsequently showed a 50% stenosis. Throughout the observation period (4 to 9 months after stenting), the other five arteries remained patent without significant narrowing (< or = 15%). Small cervical muscle branches originating from the vertebral arteries within the stented segments remained patent. No major branch occlusions of the vertebrobasilar system were detected. Stent migration or kinking did not occur. MR studies of the brain 4 months after implantation revealed no infarcted areas. These findings were confirmed with brain sections. Stented artery specimens showed delayed stent dilatation. A comparison of the total mean thickness of intima covering the five 30- to 40-mm stents removed at 4, 6, and 9 months showed no significant difference (338, 332, and 389 microns, respectively). Histologic findings verified the macroscopic impression of a thicker intima at the inner curve of the stented artery segments and at the junctions of the stent filaments. The shortest (10 mm) stent had the thinnest neointimal growth (155 microns). Stented vessels showed compression of the media with atrophy, but without necrosis or perforation. Scanning electron photomicrographs revealed intact endothelial cell linings with typical elongated cells.CONCLUSIONSNo significant risk of thromboembolic events exists after implanting these nitinol stents in nonatherosclerotic vertebral arteries in dogs. Thicker neointimal growth after stenting may result from either low wall shear stress with possible flow separation or from changes in the shape and size of the stent, or both.     

Iliac artery stent placement: clinical experience and short-term follow-up regarding a self-expanding nitinol stent

PURPOSE: To evaluate the effectiveness, safety, and short-term patency rates of a self-expandable nitinol stent (JostentSelfX; Abbott Laboratories, Chicago, IL) for treatment of iliac artery stenoses. MATERIALS AND METHODS: In a prospective study, 34 chronic iliac artery stenoses were primarily treated in 27 patients (mean age, 61.7 years +/- 9.4) by placement of a JostentSelfX. Handling and visibility of the stent was scored on a 4-point scale. Before stent placement, within 3 days after stent placement and at 6 months follow-up, the clinical history, clinical stage according to the Rutherford classification, and the ankle-brachial index (ABI) were assessed. Intra-arterial digital subtraction angiography including measurement of the mean pressure gradient was performed at the time of stent placement and at 6 months follow-up or in case of recurrence of symptoms. The Wilcoxon signed rank test and Kaplan-Meier method were applied for statistical analysis. RESULTS: The immediate technical success rate was 94%. The clinical success rate immediately after the procedure was 96% and 85% at 6 months follow-up. Stent placement significantly decreased the severity of stenoses as well as the mean pressure gradients and significantly increased the ABI. Handling of the stent was judged good. No misplacement occurred. Foreshortening during deployment was negligible and no stent migration was seen. However, visibility of the stent during fluoroscopy was ranked as moderate to bad. Follow-up at 6 months revealed the cumulative angiographic primary patency rate (<50% restenosis and <10 mm Hg mean pressure gradient) to be 0.96. CONCLUSION: The evaluated self-expandable nitinol stent is an effective tool in treating iliac artery stenoses. Apart from poor visibility, handling was good. The angiographic patency rate is comparable with data reported in other stent trials.     

Flared polyurethane-covered self-expandable nitinol stent for malignant biliary obstruction

PURPOSE: To determine the technical efficacy and safety of a flared polyurethane-covered self-expandable nitinol stent in the management of malignant biliary obstruction and to evaluate its clinical efficacy by estimating stent patency and patient survival rates. MATERIALS AND METHODS: Thirteen patients with common bile duct strictures (nonhilar) caused by malignant disease were treated by placement of 13 nitinol stents. The stents used include a flared section in the proximal portion (12 mm in diameter and 10 mm in length) and a section in the remnant portion that is fully covered with high-elasticity polyurethane, with an unconstrained diameter of 10 mm and a total length of 50-80 mm. Patient survival and stent patency rates were calculated with use of Kaplan-Meier survival analysis. The follow-up bilirubin and serum amylase and lipase levels were calculated, and the differences in means were evaluated with use of a Wilcoxon signed-rank test. The average follow-up duration was 22.9 weeks (range, 8-56 weeks). RESULTS: Placement was successful in all cases. The 30-day mortality rate was 0%. The survival rates were 38% and 24% at 20 and 50 weeks, respectively. Seventy-seven percent of study patients had adequate palliative drainage during their the remainder of their lives. The stent patency rates were 71% and 48% at 20 and 50 weeks, respectively. Three patients (23%) presented with stent occlusion requiring repeat intervention. There were no procedure-related complications such as proximal or distal migration. No complications occurred other than stent occlusion. One patient's stent was removed under endoscopic guidance 15 weeks after its insertion. Bilirubin levels had significantly decreased 1 week after stent insertion (P <.001). CONCLUSION: Preliminary results suggest that placement of a flared polyurethane-covered self-expandable nitinol stent is feasible and effective in achieving biliary drainage. The stents do not migrate, but there is tumor ingrowth into the flared portion of the stent. Treatment of a larger group of patients will be mandatory to validate these long-term results.     

In vivo evaluation of patency and in-stent stenoses after implantation of nitinol stents in iliac arteries using MR angiography

OBJECTIVE: Our study was a prospective in vivo study to evaluate whether MR angiography is suitable for assessing stent patency and grading in-stent stenoses and to examine whether the accuracy of MR angiography changes with time after stent implantation. SUBJECTS AND METHODS: In a prospective study, 34 iliac stenoses in 27 patients were treated by implantation of 35 nitinol stents. MR angiography was performed immediately after stent placement for 32 stents, and both digital subtraction angiography (DSA) and MR angiography were repeated at the 6-month follow-up for 23 stents. Three blinded observers assessed stent patency and the degree of in-stent stenoses on MR angiography and DSA (the standard of reference) images. The difference between the observers' grading of stenoses on DSA and on MR angiography was determined. Statistical analysis was performed using the Student's t test for paired samples. RESULTS: Stent patency was assessed correctly for all stents and both sets of MR angiography images. Evaluation of DSA 1 images (obtained at end of implantation procedure) revealed that 96.9% of in-stent stenoses were less than 50%. On DSA 2 images (obtained at follow-up), 95.7% of in-stent stenoses were graded as less than 50%. The difference between grading of stenoses on DSA and MR angiography images was 15.0% +/- 16.0% (minimum, 0.0%; maximum, 63.3%) for DSA 1 versus MR angiography 1 (statistically significant, p = 0.037) and 9.8% +/- 13.5% (minimum, 0.0%; maximum, 63.3%) for MR angiography 2 versus DSA 2 (not statistically significant, p = 0.355). CONCLUSION: Patency was correctly assessed for all stents on MR angiography. The quality of MR angiography regarding characterization of in-stent stenoses improved with time after stent placement. However, discrepancies of more than 60% between grading of lumen narrowing on DSA and MR angiography images occurred even at the 6-month follow-up. Thus, MR angiography is not yet a reliable technique for characterization of in-stent stenoses.