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.     

Treatment of a malignant stricture after esophagojejunostomy by a self-expanding metallic stent

Gianturco self-expanding metallic stents (GSs) were placed across an esophagojejunostomy which had become strictured secondary to recurrent anastomotic gastric cancer. Placement of the GS enabled the patient to take liquid food and swallow saliva, though only for a short period of time. One month after placement, the stented lumen restrictured with a markedly irregular contour. The patient's clinical status deteriorated with eventual occlusion of the stented anastomosis. The patient died of renal insufficiency 80 days after placement of the stent. There are some questions concerning the stability of applying the Gianturco-type bare stent to the digestive tract. In the future, more suitable stents will have to be developed.     

Is a flared stent effective for decreasing stent migration in canine prostatic urethra?

Background: Prostatic urethral stents are effective in relieving obstructions caused by benign prostatic hyperplasia (BPH). However, migration of these stents occurs frequently.

Purpose: To evaluate the efficacy of a flared stent for decreasing the migration rate in comparison with a straight stent in a canine prostatic urethral model.

Material and Methods: The flared stent (15 mm in diameter and 20 mm in length) was flared up to 19 mm at both ends to prevent migration. A straight stent with the same size was straight without flaring. Both stents were made of a nitinol wire filament and covered with an expanded polytetrafluoroethylene (ePTFE) membrane. The flared stent was inserted in the prostatic urethra of 10 dogs (group 1) and the straight stent in the prostatic urethra of 12 dogs (group 2). Follow-up retrograde urethrography (RUG) was performed 1, 4, and 8 weeks after stent placement. Fisher's exact test was used to compare the migration rate between the two groups. When stent migration occurred during the follow-up period, the same type of stent was inserted again.

Results: Three of 10 (30.0%) flared stents migrated into the urinary bladder between 1 week and 4 weeks after placement. Seven of 12 (58.3%) straight stents migrated into the urinary bladder 1 (n = 3), 4 (n = 1), and 8 (n = 3) weeks following placement. The flared stent group showed lower migration rate than the straight stent group, but the migration rate did not reach statistical significance (P = 0.231). After the second stent placement, one of three (33.3%) flared stents migrated again after 4 weeks and two of seven straight stents (28.6%) after 1 week.

Conclusion: Although the migration rate was not statistically significant, the flaring of the stent seemed to reduce the migration rate in comparison with straight stents in a canine prostatic urethral model. However, the migration rate of the flared stent was still high, and further developments are required to decrease migration rate.     

Self-expanding endovascular graft: an experimental study in dogs

An arterial endovascular graft was constructed by wrapping an expandable nylon mesh around a framework of Gianturco self-expanding metallic stents. The devices were passed through a 12-French Teflon catheter and positioned in the normal abdominal aorta of five dogs, two of which also had a device placed in an external iliac artery. At follow-up (1-6 months), all grafts remained patent, even though slight luminal narrowing due to neointimal encasement was noted. Histologically, all grafts were covered by neointimal proliferation at the time of removal. The graft material expanded with the stents, resulting in a tight fit between the graft and the vessel wall. Side branches narrowed but remained open because of the size of the nylon mesh. No migration of the grafts equipped with a barbed lead stent was noted. Expandable nylon mesh can be used as an endovascular graft material when wrapped around a framework of self-expanding stents. The resulting device can be easily delivered via transcatheter techniques, and once placed in a vessel, the nylon acts as a support for neointimal encasement, which forms a new vascular lumen.     

Evaluation of the Effects of Temporary Covered Nitinol Stent Placement in the Prostatic Urethra: Short-Term Study in the Canine Model

Purpose To evaluate the effect of temporary stent placement on the canine prostatic urethra. Methods Retrievable PTFE-covered nitinol stents were placed in the prostatic urethras of 8 beagle dogs under fluoroscopic guidance. Retrograde urethrography was obtained before and after stenting. Retrograde urethrography and endoscopy were performed 1 and 2 months after deployment. The endoscopic degree of hyperplasia was rated on a scale of 0 to 4 (0 = absence, 4 = occlusion). On day 60, stents were removed and urethrography was performed immediately before euthanasia. Pathologic analysis was performed to determine the degree of glandular atrophy, periurethral fibrosis, and urethral dilation. Results Stent deployment was technically successful in 7 animals, and failed in 1 dog due to a narrow urethral lumen. Complete migration was seen in 2 animals at 1 month, and an additional stent was deployed. On day 30, endoscopy showed slight hyperplasia (grade 1) in 3 animals. On day 60, moderate hyperplasia (grade 2) was evidenced in 4 cases. No impairment of urinary flow was seen during follow-up. Retrieval was technically easy to perform, and was successful in all dogs. The major histologic findings were chronic inflammatory cell infiltrates; prostate glandular atrophy, with a mean value of 1.86 (SD 0.90); periurethral fibrosis, with a mean ratio of 29.37 (SD 10.41); and dilatation of the prostatic urethra, with a mean ratio of 6.75 (SD 3.22). Conclusion Temporary prostatic stent placement in dogs is safe and feasible, causing marked enlargement of the prostatic urethral lumen. Retrievable covered stents may therefore be an option for bladder outlet obstruction management in men.     

Tissue hyperplasia: influence of a paclitaxel-eluting covered stent--preliminary study in a canine urethral model

PURPOSE: To evaluate a paclitaxel-eluting covered stent in reduction of tissue hyperplasia after stent placement in a canine urethral model. MATERIALS AND METHODS: Procedures were performed in accordance with the National Institutes of Health guidelines for humane handling of animals; approval of the committee of animal research was obtained. Twenty paclitaxel-eluting polyurethane-covered stents (drug stents) and 20 polyurethane-covered stents (control stents) were placed alternately between the proximal and distal urethra in 20 male dogs. The dose of paclitaxel was approximately 1800 mug in each drug stent but absent in each control stent. Dogs were sacrificed either 4 (n = 10) or 8 (n = 10) weeks after stent placement. The percentage diameter of stenosis was assessed with follow-up retrograde urethrography and histologic findings obtained after sacrifice and compared between drug stents and control stents and between the proximal and the distal urethra. RESULTS: Two drug stents partially migrated during retrograde urethrography immediately after stent placement; they were removed and replaced with a second stent during the same procedure. There was a strong tendency toward a lower percentage diameter of stenosis and numeric mean values of the four histologic findings, which indicates less formation of tissue hyperplasia in the proximal urethra than in the distal urethra. In particular, thickness of the papillary projection denoting the entire thickness of hyperplastic reaction was significantly less in drug stents than in control stents in the proximal urethra in the 8-week group (P = .016, Mann-Whitney U test). CONCLUSION: Local delivery of paclitaxel via covered stents has the potential to reduce tissue hyperplasia secondary to stent placement in a canine urethral model. With stent placement, there are distinct differences of tissue hyperplasia between the proximal and distal urethra.     

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.     

Flexible tantalum stents: Effects in the stenotic canine urethra

Purpose Evaluate the effects of flexible tantalum stents (Strecker) implanted into stenotic canine urethras.Methods Eight conditioned, adult, German shepherd dogs, weighing 30–40 kg, were used. Strictures were created surgically in the bulbar urethra just proximal to the os penis. Two months postsurgery, strictures were documented radiographically and then balloon dilated. Following dilatation, a single Strecker stent was placed across the stricture. Stents were 7 mm in expanded diameter and either 2 or 4 cm in length. Retrograde urethrography was performed immediately after stent placement and then biweekly for up to 12 months. Two dogs were sacrificed at 2, 4, 6, and 12 months post-stenting, and necropsy was performed. The urethra was excised, fixed, and examined by scanning electron and light microscopy.Results Clinical success was achieved without complications in all animals. Hyperplasia of the urothelium was noted 4–6 weeks after stent placement and was most pronounced at 4–6 months. Mucosal folds were found between the stent struts. Restenosis occurred at the distal end of the stent in one dog. Histological alterations were noted in the deeper layers of the urethral wall.Conclusion Strecker stents were well tolerated in all animals and seem useful for the treatment of urethral strictures.Presented at CIRSE Annual Meeting and Postgraduate Course, Budapest, June 20–24, 1993     

Experimental study of the intraurethral placement of expandable metallic stents

Various types of Gianturco expandable metallic stents were implanted into the urethra of four dogs in order to evaluate the suitable expandability of the stents in urethra and also to determine the effect of the stents on the urethral wall. The stent of 1.5 cm in length and constructed of 0.010 inch round stainless steel wire with twelve zigzag bends showed the suitable expandability on the canine urethra compared to the other stents. The urethra remained patent and the inflammatory changes on the urethral wall were moderately noted. No hematuria or calcifications around the stents were noted in any dogs. The experimental data showed a potential clinical application.     

Gianturco self-expanding stents: Clinical experience in the vena cava and large veins

Twenty-five patients with stenosis of the vena cava (21) and other large veins (4) have been treated with self-expanding Gianturco metallic stents. Eighteen patients had superior vena cava syndrome. In 17, the stricture was due to malignant superior vena cava compression recurrent after maximum tolerance radiotherapy and/or chemotherapy. In 16 of these patients there was early symptomatic relief. In 1 patient with a benign posttraumatic superior vena cava stricture, the stenosis was not relieved, and occlusion occurred after 1 month. Stenoses associated with dialysis shunts were relieved in 2 other patients. Two malignant and one benign inferior vena cava stenoses were relieved either until death, or in the benign case, for 30 months. One malignant subclavian vein obstruction occluded after 24 h due to stent misplacement and another with extrinsic mediastinal compression remained patent until death, extensive thrombus having been lysed prior to stent placement. The results of this short series suggest that the Gianturco self-expanding stent in the vena cava and large veins is easy and safe to place, and in most cases produces almost immediate palliation of the distressing effects of venous obstruction, often in a preterminal and inoperable patient.     

Stenosis of the vena cava: preliminary assessment of treatment with expandable metallic stents

To test the ability of Gianturco expandable metallic stents to dilate and maintain patency in stenotic venae cavae, stenosis of the inferior vena cava was created in seven mongrel dogs by the percutaneous injection of absolute ethanol into the paravascular retroperitoneal space. Gianturco stents, placed across the stenotic segment, resulted in successful dilatation with improved hemodynamics in four dogs. The stents failed to dilate an occluded vena cava in one dog; in the remaining dogs, stent placement was complicated by early migration and occlusion. Gianturco stents were placed in two patients, one with superior vena cava syndrome and one with retroperitoneal fibrosis that obstructed the inferior vena cava, and resulted in immediate relief of presenting symptoms. These results should be viewed cautiously, but further investigation into the clinical use of the stents is indicated, especially for patients for whom other treatments are difficult.     

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.     

Influence of a dexamethasone-eluting covered stent on tissue reaction: an experimental study in a canine bronchial model

This study was designed to evaluate the feasibility and efficacy of a dexamethasone (DXM)-eluting, covered, self-expanding metallic stent to reduce tissue reaction following stent placement in a canine bronchial model. We placed a DXM-eluting, polyurethane-covered, self-expanding metallic stent (drug stent, DS) and a polyurethane-covered, self-expanding metallic stent (control stent, CS) alternately in each left main bronchus and left lower lobe bronchus in 12 dogs. The stents were 20 mm in diameter and length when fully expanded. The dose of DXM was approximately 36.7 mg in each DS, but was absent in the CS. The dogs were euthanased 1 week (n=4), 2 weeks (n=4) or 4 weeks (n=4) after stent placement. Histologic findings, such as epithelial erosion/ulcer or granulation tissue thickness, were obtained from the mid-portion of the bronchus, where the stent had been placed, and evaluated between DS and CS. There were no procedure-related complications or malpositioning of any of the bronchial stents. Stent migration was detected in one dog just before euthanasia 1 week following stent placement. Stent patency was maintained until euthanasia in all dogs. Epithelial erosion/ulcer (%) was significantly less in the DS (mean±standard deviation, 46.88±23.75) than in the CS (73.75±14.08) (P=0.026) for all time-points. There was a decrease in epithelial erosion/ulcer as the follow-up period increased in both DS and CS. The granulation tissue thickness (mm) was less in DS (2.63±2.05) than in CS (3.49±2.95), although the difference was not significant (P=0.751) for all time-points. There was a tendency toward an increase in granulation tissue thickness and chronic lymphocytic infiltration as the follow-up period increased in both DS and CS. In conclusion, DXM-eluting, covered, self-expanding metallic stent seems to be effective in reducing tissue reaction secondary to stent placement in a canine bronchial model.     

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.     

Covered Stents in the Treatment of Pulmonary Arteriovenous Malformations

Seven patients with pulmonary arteriovenous malformations (PAVMs) not well suited to coil and/or plug treatment were treated with expanded polytetrafluoroethylene–covered stents. Mean diameter of treated arteries was 6 mm. Complete technical success was achieved in 7 of 8 PAVMs, 6 using only covered stents and 1 using both a covered and a bare stent owing to endoleak. In 1 patient, the parent vessel was sacrificed after identification of additional feeding vessels following stent graft placement. In 6 patients with median imaging follow-up of 8 months (range, 1–121 months), all stent grafts were patent, and all treated PAVMs were completely excluded without persistence.     

Renal cyst pseudoenhancement: evaluation with an anthropomorphic body CT phantom

PURPOSE: To evaluate the feasibility of using a retrievable urethral stent and to evaluate whether granulation tissue resolves after stent removal in a canine urethra. MATERIALS AND METHODS: Polyurethane-covered retrievable 0.10-mm-thick (n = 11) or 0.15-mm-thick (n = 10) nitinol wire stents were placed in the urethras of 20 dogs. In one dog, a second stent was placed in the urethra because of complete migration of the first stent into the urinary bladder. The stents were removed with retrieval hook wires 4 weeks (n = 10) and 8 weeks (n = 10) after placement. Fourteen dogs were sacrificed just after stent removal, and the other six dogs were sacrificed 2 weeks after stent removal. Information concerning procedure success, stent migration, and tissue response was obtained. RESULTS: Stent placement was technically successful in all dogs. Follow-up urethrograms showed partial (n = 4) or complete (n = 1) stent migration. Stent removal failed in two dogs due to partial or complete migration. Granulation tissue was observed at both ends of the stent in 17 dogs. Urethrograms and urethral specimens obtained 2 weeks after stent removal showed diminished granulation tissue and decreased thickness of the papillary projections of the epithelium compared with results obtained immediately after stent removal. CONCLUSION: Although some design modifications are necessary to reduce current complications, the polyurethane-covered retrievable nitinol stent seems feasible for use in the urethra. Stent-induced granulation tissue formation improved after stent removal.     

Treatment of Takayasu's aortitis with self-expanding metallic stents (Gianturco stents) in two patients

Gianturco self-expanding metallic stents were successfully placed to treat incomplete balloon dilatation of the abdominal aorta in 2 patients with Takayasu's aortitis. In 1 case eleven 1-cm long, 1-cm diameter stents were inserted in tandem to bridge a long stenosis. In the other patient, four stents 1.5 cm long, 1.5 cm in diameter were inserted in tandem to bridge what had been a complete occlusion prior to balloon angioplasty. Clinical symptoms, as well as angiographic findings, improved significantly after placement of the stents. The patients underwent repeat aortography at 10 and 8 months, respectively, and were followed clinically for a total of 18 months and 15 months, respectively, without clinical evidence of deterioration. Our results show the usefulness of expandable metallic stents in the treatment of aortic stenosis due to Takayasu's aortitis that remains unresponsive to balloon dilatation.     

Endovascular placement of self-expanding nitinol coil stents for the treatment of femoropopliteal obstructive disease

PURPOSE: To report on a prospective two-center study to evaluate safety and effectiveness of a self-expanding nitinol coil stent in patients with femoropopliteal obstructive disease. MATERIALS AND METHODS: The IntraCoil nitinol stent was used in 37 patients (28 men and nine women; mean age, 62.4 y plus minus 10.7; range, 43-81 y) presenting with high-grade stenoses (n = 23) or short (<3 cm) occlusions (n = 17) of the superficial femoral artery (SFA; n = 33) or popliteal artery (n = 4). Indications for stent placement were significant residual stenosis (>30%) or dissection after angioplasty. Follow-up evaluations with measurement of the Doppler ankle-brachial index (ABI), assessment of Rutherford clinical stage, and color-coded duplex sonography were performed at discharge and 1, 3, 6, 12, and 18 months thereafter. Primary endpoints of the study were immediate technical and clinical success and 1-year patency. RESULTS: Initial technical success was achieved in all patients. In 10 patients (27%), more than one 40-mm-long device had to be implanted for total lesion coverage; in three patients (8.1%), stents were placed in two separate segments of the SFA simultaneously. The total number of stents deployed was 50. Stent placement induced an initial improvement of the ABI from 0.54 plus minus 0.2 to 0.92 plus minus 0.11 (P <.01). Follow-up data for 12 months after treatment are available for 29 of 37 patients (78.4%); mean follow-up is 15.6 months (range, 1-26 mo). Primary patency rates at 6 and 12 months were 97.1% (SE = 2.9) and 86.2% (SE = 6.5). The primary assisted patency rate was 100% at 12 months. CONCLUSION: Endovascular placement of the IntraCoil self-expanding nitinol coil stent for salvage of failed angioplasty in patients with femoropopliteal obstructive disease is an effective and safe procedure with promising mid-term results.     

Iliac artery stenosis and occlusion: preliminary results of treatment with Gianturco expandable metallic stents

Ten patients with atherosclerotic stenosis or occlusion of the iliac artery were treated with Gianturco expandable metallic stents. In the five cases of stenosis, only balloon dilation was performed prior to placement of stents. The five patients with occluded arteries were given intraarterial infusions of urokinase before balloon dilation and stent placement. Clinical symptoms improved in all patients, and no technical failures or complications occurred. Doppler ankle-brachial index studies were performed in nine cases, and in all nine cases the indexes improved after stent placement. During follow-up of 2-18 months (mean, 10.3 months), all arteries remained patent. Follow-up angiograms showed slight intimal thickening and no restenosis. Long-term follow-up and more clinical experience will be necessary to evaluate the efficacy of this stent. However, preliminary results suggest that the Gianturco expandable metallic stent is of value in the treatment of arterial occlusive disease.     

Expandable Metallic Stent Treatment for Malignant Colorectal Strictures

Four patients were treated by placement of an expandable metallic stent (two Gianturco Z-stents, two Ultraflex stents) for malignant colorectal strictures. All four patients were able to defecate after stent placement. Stent migration was recognized in one patient. Two patients suffered from tenesmus after stent placement.