Covered retrievable tracheobronchial hinged stent: an experimental study in dogs.

PURPOSE: To evaluate the safety and technical feasibility of the use of a covered retrievable tracheobronchial hinged stent and investigate the histopathologic airway changes after placement and removal of the stent in dogs. MATERIALS AND METHODS: The experimental stent was composed of tracheal and bronchial stents that were connected together at their ends. Each stent was woven from a single thread of 0.2-mm-diameter nitinol wire filament in a tubular configuration and covered with polyurethane solution by a dipping method. Drawstrings were attached at the upper end of the tracheal stent for stent removal. Under fluoroscopic guidance, 20 stents were placed at the lower trachea and left main bronchus in 20 dogs and were electively removed 4 weeks (n = 10) or 8 weeks (n = 10) after placement. Ten dogs were killed just after stent removal and the remaining 10 were killed 2 weeks after stent removal. RESULT: Stents were successfully placed in all dogs. Pneumonia was observed in three dogs. Stent migration occurred in seven dogs (35%). Except for two cases of stent expectoration, 18 stents were easily removed within a few minutes. There was considerable granulation tissue proliferation and inflammatory reaction in the airways of the dogs that were killed just after stent removal. The pathologic changes of the airways returned to almost-normal conditions 2 weeks after stent removal. CONCLUSION: Placement and removal of a covered retrievable tracheobronchial hinged stent seems to be feasible, and histopathologic changes of the airway related to the stents returned to normal 2 weeks after stent removal.     

Retrievable covered nitinol stents: experiences in 108 patients with malignant esophageal strictures

PURPOSE: The authors report their experience with three types of retrievable covered nitinol stents in patients with malignant esophageal strictures. MATERIALS AND METHODS: Three types of retrievable covered nitinol stents were designed. Type A stents were placed in 45 patients, type B stents were placed in 29 patients, and type C stents were placed in 34 patients. The stents were removed with use of a stent retrieval set under fluoroscopic guidance when the stents caused complications. Stent patency, symptom relief, survival rate, and complications were analyzed relative to stent type and radiation therapy. RESULTS: The timing of radiation and the stent type have significant effects on occurrence of complications such as stent migration and fistula formation (P =.002 and P = 0.029, respectively). Complications were significantly more frequent in patients with the type B stent than those with type A or type C stents (P =.008). Patients who underwent radiation therapy before stent placement or who underwent no radiation therapy experienced substantially less complications than those who underwent radiation therapy after stent placement (P =.005 and P <.001, respectively). The survival period was significantly longer in patients who underwent radiation therapy after stent placement than in the other groups (P =.034). Stents were removed from 15 patients (14%) 2 days to 16 weeks (mean, 4 weeks) after stent placement as a result of severe pain (n = 7), stent migration (n = 6), or stent deformity (n = 2). Stent removal was well tolerated in all patients. CONCLUSION: Use of retrievable covered nitinol stents seems to be a safe and effective method of treatment in patients with malignant esophageal strictures. However, removal of the stents was needed in 14% of the patients because of complications. Patients who underwent radiation therapy after stent placement and those with the type B stent experienced more complications than other patients.     

Treatment of tracheobronchial obstruction with a polytetrafluoroethylene-covered retrievable expandable nitinol stent

PURPOSE: To evaluate the clinical effectiveness of polytetrafluoroethylene (PTFE)-covered retrievable expandable nitinol stents in tracheobronchial strictures. MATERIALS AND METHODS: With fluoroscopic guidance, PTFE-covered retrievable expandable nitinol stents were placed in 15 symptomatic patients with benign (n = 6) or malignant (n = 9) tracheobronchial strictures. Complications and improvement in respiratory status were evaluated. Stents were removed electively 6 months after placement in benign strictures or if complications occurred. Membrane degradation or separation from the wire mesh was evaluated in removed stents. RESULTS: A total of 17 stents were successfully placed and were well tolerated in all patients. Sputum retention, stent migration, and tissue hyperplasia occurred in 23.5% (n = 4), 17.6% (n = 3), and 17.6% (n = 3) of stents, respectively. A total of 11 stents were successfully removed electively 6 months after placement (n = 4) or when complications occurred (n = 7). All 11 such stents were removed without difficulty with use of standard techniques, antecedent balloon dilation being necessary in two cases as a result of tissue hyperplasia. No removed stent showed signs of membrane degradation, and two removed stents showed signs of membrane separation from the mesh. CONCLUSIONS: PTFE-covered retrievable expandable nitinol stents were effective in the treatment of tracheobronchial strictures. Stent removal was easy with use of standard techniques, and no removed stent showed evidence of membrane degradation.     

Covered retrievable expandable nitinol stents in patients with benign esophageal strictures: initial experience

PURPOSE: To investigate the safety and clinical effectiveness of covered retrievable expandable nitinol stents in 25 patients with a benign esophageal stricture. MATERIALS AND METHODS: Under fluoroscopic guidance, covered retrievable expandable nitinol stents were placed in 25 patients with a benign esophageal stricture and were removed with a retrieval hook 1-8 weeks later. RESULTS: Stent placement was successful in all patients, with no procedural complications. After stent placement, all patients could ingest solid food. The stents were successfully removed from all but two patients. One patient passed the stent via the rectum, and the other regurgitated a high cervical stent. After stent removal, one patient developed a small esophagobronchial fistula, which spontaneously sealed within 1 week of stent removal. After stent removal or migration, all patients could ingest solid food. During follow-up (mean, 13 months; range, 2-25 months) after stent removal or migration, 12 patients maintained their improvement in dysphagia and needed no further treatment. Thirteen patients with recurrence were treated by means of repeat balloon dilation. CONCLUSION: Use of retrievable expandable nitinol stents seems to be a safe and effective method of treatment in selected patients with benign esophageal strictures.     

Malignant tracheobronchial strictures: palliation with covered retrievable expandable nitinol stent

PURPOSE: To evaluate the safety and clinical effectiveness of a covered retrievable expandable nitinol stent for the treatment of malignant tracheobronchial stricture and/or esophagorespiratory fistula (ERF). MATERIALS AND METHODS: With fluoroscopic guidance, stents were placed in 35 symptomatic patients with malignant tracheobronchial stricture and/or ERF in most cases caused by lung or esophageal cancer. The site of stricture was most commonly at the trachea or left main bronchus. If there were complications, the stent was removed with a retrieval set. Nine patients had combined symptomatic ERF. RESULTS: A total of 47 tracheobronchial stents were placed and were technically successful and well-tolerated in all patients. Improvement of dyspnea was achieved in 92% of the patients (24 of 26 patients). Associated ERF in nine patients was effectively treated with tracheobronchial stent placement with or without esophageal stent placement. Stent migration, tumor overgrowth, symptomatic sputum retention, and hemoptysis occurred in 17% (6/35), 6% (2/35), 20% (7/35), and 17% (6/35) of patients, respectively. There were no documented cases of tumor ingrowth. Stent removal was performed easily in five patients when stent migration (n = 2), severe pain (n = 1), tumor overgrowth (n = 1), or persistent gastrobronchial fistula (n = 1) developed. All patients died 2 days to 26 weeks (mean, 9.62 weeks) after stent placement because of disease progression (n = 18), pneumonia (n = 9), hemoptysis (n = 5), or unknown cause (n = 3). CONCLUSION: Use of a covered retrievable expandable nitinol stent is a safe and effective method for relieving dyspnea. This procedure contributed to improved quality of life for patients with malignant tracheobronchial stricture and/or ERF. Stent retrievability was useful in resolving stent-related complications.     

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.     

Results of temporary placement of covered retrievable expandable nitinol stents for tuberculous bronchial strictures

Covered retrievable expandable nitinol stents were successfully placed in nine patients with tuberculous bronchial strictures refractory to balloon dilation. Complications included stent migration (n = 1) and tissue hyperplasia at the proximal portion of the stent (n = 2). During the follow-up period (5-52 months), stricture recurred in three of five patients (60%) after temporary stent placement for 2 months, whereas stricture did not recur in the other four patients after temporary stent placement for 6 months. Temporary placement of covered retrievable stents appears to be an effective method for the treatment of patients with tuberculous bronchial strictures refractory to balloon dilation.     

Comparison of temporary and permanent stent placement with concurrent radiation therapy in patients with esophageal carcinoma

PURPOSE: To assess the clinical effectiveness of temporary metallic stent placement with concurrent radiation therapy in patients with esophageal carcinoma by comparing it with permanent stent placement with concurrent radiation therapy. MATERIALS AND METHODS: Covered retrievable expandable nitinol stents were placed in 47 patients with esophageal carcinoma 1 week before starting radiation therapy; the stents were electively removed 4 weeks after placement in 24 patients (group A), while not electively removed in the other 23 patients (group B). In cases of complications, the stents were also removed from patients in groups A and B. The dysphagia score, complications (severe pain, granulation tissue formation, stent migration, esophagorespiratory fistula, and hematemesis), tumor overgrowth/regrowth, reintervention rates, and dysphagia-progression-free and overall survival rates were compared in the two groups. RESULTS: Stent placement or removal was technically successful and well tolerated in all patients. The dysphagia score was significantly improved in both groups after stent placement (P < .01). Each of the stent-related complications was less in group A than in group B but there was no significant difference. However, the total number of patients with one or more than one complications and who needed related reinterventions was significantly less in group A than in group B (P = .042 and .030, respectively). Tumor overgrowth/regrowth and the total number of patients who required related reinterventions was not significantly different (P = 1.00 and .517, respectively). Dysphagia-progression-free and overall survival rates were significantly longer in group A than in group B (P = .005 and .001, respectively). CONCLUSION: Temporary placement of a covered retrievable expandable metallic stent with concurrent radiation therapy for patients with esophageal carcinoma is beneficial for reducing complications and related reinterventions and for increasing resultant survival rates compared with permanent esophageal stent placement.     

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.     

Polydioxanone Biodegradable Stent Placement in a Canine Urethral Model: Analysis of Inflammatory Reaction and Biodegradation

PurposeTo investigate the inflammatory reaction and perform quantitative analysis of biodegradation after placement of a polydioxanone (PDO) biodegradable stent in a canine urethral model.Materials and MethodsPDO biodegradable stents were placed in the proximal and distal urethra of nine male mongrel dogs. The dogs were euthanized 4 weeks (group A; n = 3), 8 weeks (group B; n = 3), or 12 weeks (group C; n = 3) after stent placement. The luminal diameter of the stent-implanted urethra was assessed by follow-up retrograde urethrography, and histologic findings were obtained after the dogs were killed. Stents were removed after euthanasia, and their surface morphology and molecular weight were evaluated. Hematologic examination was performed to evaluate inflammatory reaction.ResultsStent placement was technically successful in all dogs. The average luminal diameter gradually decreased. The average number of epithelial layers (2.93 vs 4.42; P < .001), the average thickness of papillary projection (0.80 mm vs 1.28 mm; P < .001), and the average thickness of submucosal fibrosis (0.34 mm vs 0.49 mm ; P < .001) were significantly increased in group B versus group A. There were no significant differences between group B and group C. The average inflammatory cell infiltration did not differ significantly in the three groups. Molecular weight losses were 54% in group A and 84% in group B. In group C, PDO stents were completely decomposed.ConclusionsAn experimental study in a canine urethral model has demonstrated acceptable inflammatory reaction with gradually increasing granulation tissue but no luminal obstruction within 12 weeks.     

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.     

Temporary placement of covered retrievable expandable nitinol stents with barbs in high-risk surgical patients with benign prostatic hyperplasia: work in progress

Purpose

To report the use of a newly constructed, covered, retrievable, expandable nitinol stent with barbs to overcome the problem of stent migration associated with conventional covered prostatic expandable stents and to evaluate prospectively the technical feasibility and clinical effectiveness of the stents in patients with benign prostatic hyperplasia (BPH).

Materials and Methods

A covered retrievable expandable nitinol stent with four barbs was placed with use of an 18-F stent delivery system in seven consecutive patients with symptomatic BPH who had high operative risks. Age range of patients was 62–83 years (mean 74 years). In cases in which the stent migrated, it was replaced with a stent with eight barbs. The stents were routinely removed 4 months after placement using a 21-F stent removal set.

Results

Stent placement was technically successful and well tolerated in six of the seven patients. The remaining patient needed a second stent placement after removal of the first stent. The stent with four barbs migrated into the urinary bladder in four patients (57%); three of these patients received a second stent with eight barbs with good results, and the fourth patient did not need further treatment because his symptoms improved. Routine removal of the stent 4 months after placement was performed in three of the seven patients with good results.

Conclusions

Retrievable stents with eight barbs seem to overcome the problem of stent migration associated with conventional prostatic expandable stents. Preliminary results suggest that stents with barbs are both feasible and effective in patients with BPH.     

Malignant gastric outlet obstructions: treatment by means of coaxial placement of uncovered and covered expandable nitinol stents

PURPOSE: To assess whether coaxial placement of uncovered and covered expandable nitinol stents overcomes the disadvantages of the increased migration rate seen with covered stents and the tumor ingrowth seen in uncovered stents in the treatment of malignant gastric outlet obstructions. MATERIALS AND METHODS: Two types of expandable nitinol stent were designed: an uncovered stent and a covered stent. Under fluoroscopic guidance, the uncovered and covered stents were placed coaxially with complete overlap in 39 consecutive patients with malignant gastric outlet obstruction caused by stomach cancer. Food intake capacity was graded on a scale of 0-4. Stent patency rate was estimated by the Kaplan-Meier method. RESULTS: Technical success rate was 97% (38 of 39 patients). After stent placement, food intake capacity improved at least one grade in 36 patients. Stent migration occurred in three patients (8%), that is, partial (n = 2) or complete (n = 1) upward migration of the inner covered stent into the stomach. Two of these patients were treated by placement of an additional covered stent. During the mean follow-up period of 134 days (range, 15-569 d), 10 patients developed recurrent symptoms of obstruction with tumor overgrowth being the most common cause. Nine underwent placement of an additional covered stent with good results. The median period of primary stent patency was 157 days (mean, 278 d). The 30-, 60-, and 180-day patency rates were 97%, 91%, and 39%, respectively. Four patients (10%) died within 1 month after the procedure. CONCLUSION: Coaxial stent placement technique seems to contribute to decreasing the migration rate of the stent and decrease the rate of recurrent obstruction by preventing or delaying tumor ingrowth.     

Fate of migrated esophageal and gastroduodenal stents: experience in 70 patients

PURPOSE: To investigate the frequency of esophageal and gastroduodenal stent migration and the fate of such stents. MATERIALS AND METHODS: The authors studied five types of covered metal stents. Type A stents were nonretrievable polyurethane-covered stents with shouldered ends (n = 169), type B stents were retrievable polyurethane-covered stents with shouldered ends (n = 62), type C stents were retrievable polyurethane-covered stents with flared ends (n = 72), type D stents were retrievable polytetrafluoroethylene-covered stents with shouldered ends (n = 369), and type E stents were separated stents (n = 216). Types A-D stents were esophageal stents, and the type E stent was a gastroduodenal stent. Stents were placed in 888 patients with either benign (n = 43) or malignant (n = 845) causes of stricture. The rate of stent migration was analyzed relative to completeness of migration, the cause of obstruction, stent type, and stent placement location. The fate of migrated stents and the treatment of patients were evaluated. RESULTS: Stent migration occurred in 70 of the 888 patients (7.9%). Migration occurred in 11 of the 43 patients (25%) with benign cause of strictures and 591 of the 845 patients (7.0%) with malignant cause. The migration rates for types A, B, C, D, and E stents were 10%, 4.8%, 24%, 7.3% and 2.8%, respectively. Of the 70 migrated stents, 45 had complete migration and 25 had partial migration. The anastomotic sites were the areas most commonly associated with migration (16%), but this was not statistically significant. Forty of the 70 migrated stents were removed with retrieval devices under fluoroscopic guidance because they were not passed with stool and possibility of complications related to migrated stents. The remaining 30 stents exited via the rectum (n = 15), remained in the body without complications (n = 12), or were surgically removed because they caused complicated intestinal obstructions (n = 3). CONCLUSION: The overall migration rate for esophageal and gastroduodenal stents was 7.9%. Most migrated stents were removed nonsurgically, exited the body spontaneously, or remained in the body in an uncomplicated state. Surgical stent removal was necessary in three patients (4.3%) due to complicated intestinal obstructions.     

Removal of retrievable esophageal and gastrointestinal stents: experience in 113 patients

OBJECTIVE: Although there are frequent clinical situations in which esophageal and gastrointestinal stents should be removed, nonsurgical stent removal has been difficult. The purpose of our study was to describe the safety and efficacy of removing the retrievable nitinol stents with a retrieval hook. MATERIALS AND METHODS: Under fluoroscopic guidance, the removal of 119 esophageal, six gastroduodenal, and five rectal retrievable stents was attempted in 113 patients using a retrieval hook. Indications for stent removal included migration (n = 35), severe pain (n = 23), formation of a new stricture (n = 13), incomplete stent expansion (n = 7), airway compression (n = 2), esophagorespiratory fistula (n = 2), malpositioned stent (n = 1), and hematemesis (n = 1). The remaining 46 stents were electively removed. RESULTS: Of the 130 stents, 127 (97.7%) were successfully removed despite the following difficulties: untied drawstrings (n = 4), separation of the stent (n = 3), and fracture (n = 2) or disconnection (n = 2) of a retrieval hook. The removal procedure failed in three cases (2.3%). The causes of failure were the inability to place the hook into the migrated stent (n = 2) and a tight stricture above the migrated stent (n = 1). The procedure-related complications included minor (n = 4) and major (n = 1) bleeding and intramural rupture (n = 3). One patient died of major bleeding after removal of an esophageal stent. CONCLUSION: The stent retrieval hook is useful for removing retrievable esophageal and gastrointestinal stents.     

Autologous vein stent-graft: feasibility study

PURPOSE: To evaluate expandable stents healed into vein wall as autologous vein stent-grafts for endoluminal grafting. MATERIALS AND METHODS: Balloon expandable stents were placed into external jugular veins of eight dogs. Stent and vein patency was followed by ultrasonography. Five weeks after stent placement, jugular veins with endothelialized stent were harvested. The autologous vein stent-grafts were divided into two groups. In group A, autologous vein stent-grafts (n = 3) were placed immediately into Baker solution for microscopic examination. In group B, autologous vein stent-grafts (n = 3) underwent mechanical manipulation; they were compressed, mounted on angioplasty balloon, pushed through a 9-F sheath and dilated. The autologous vein stent-graft endothelialization and changes after mechanical manipulation were evaluated by light and electron microscopy. RESULTS: Stent placement was successful in seven dogs. One stent migrated into the pulmonary artery. One well placed stent was damaged by compression dressing and thrombosed. At 5 weeks, gross and microscopic examinations revealed the autologous vein stent-grafts were fully covered by a 0.115- +/- 0.036-mm-thick neointimal layer. Small wall thrombus was observed in one autologous vein stent-graft. Repeated manipulations did not result in any intimal damage or stent loosening in the autologous vein stent-grafts. CONCLUSION: Expandable stents healed into a vein have potential to be used as autologous vein stent-grafts for endoluminal grafting without risk of disruption during percutaneous transcatheter introduction.     

Treatment of Esophagopleural Fistulas Using Covered Retrievable Expandable Metallic Stents

PurposeTo evaluate the clinical efficacy of placement of covered retrievable expandable metallic stents for esophagopleural fistulas (EPFs).Materials and MethodsDuring the period 1997–2013, nine patients with EPF were treated using covered retrievable expandable metallic stents. The underlying causes of EPF were esophageal carcinoma (n = 6), lung cancer (n = 2), and postoperative empyema for Boerhaave syndrome (n = 1).ResultsTechnical success was achieved in eight patients (88.9%). In one patient, incomplete EPF closure was due to incomplete stent expansion. Clinical success, defined as complete EPF closure within 7 days, was achieved in five patients (55.6%). Overall fistula persistence (n = 1) or reopening (n = 4) occurred in five patients (55.6%) 0–15 days after stent placement. The causes of reopening were due to the gap between the stent and the esophagus (n = 3) or stent migration (n = 1). For fistula persistence or reopening, additional interventional management, such as gastrostomy, stent removal, or stent reinsertion, was performed. Stent migration occurred as a complication in one patient with EPF from a benign cause secondary to postoperative empyema. In the eight patients who died during the follow-up period, the mean and median survival times were 78.8 days and 46 days, respectively.ConclusionsPlacement of a covered expandable metallic esophageal stent for the palliative treatment of EPF is technically feasible, although the rate of clinical success was poor secondary to fistula persistence or reopening. Fistula reopening was caused by the gap between the stent and the esophagus or by stent migration, and additional interventional treatment was useful to ensure enteral nutritional support.     

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.     

Recurrent traumatic urethral strictures near the external sphincter: treatment with a covered,retrievable, expandable nitinol stent--initial results

PURPOSE: To investigate the clinical effectiveness of a covered, retrievable, expandable nitinol stent in treating traumatic urethral strictures near the external sphincter. MATERIALS AND METHODS: The stent was 10 mm in diameter when fully expanded and 40-50 mm long. To make it removable, two nylon drawstrings were attached to its lower inner margin. Twelve consecutive men (19-67 years; mean age, 47 years) with traumatic urethral strictures near the external sphincter that were refractory to endoscopic urethrotomy were treated. With fluoroscopic guidance, a stent was placed to completely bridge the external sphincter. The stent was electively removed with a retrieval hook wire 2 months after placement. Stent placement and removal were successful in all patients, with no procedural complications. RESULTS: Mean maximum urine flow rate was 5 mL/sec (range, 3-7 mL/sec) before stent placement and 27 mL/sec (range, 16-40 mL/sec) at 1 week after placement. During the mean follow-up of 20 months (range, 2-37 months) after the first stent removal, strictures recurred in eight of 12 patients. For the eight patients with recurrence, a second stent was placed and 4 months later was removed from seven of the eight patients. During the mean follow-up of 18 months (range, 4-32 months) after the second stent removal, strictures recurred in two patients, in whom a third stent was placed and then removed 4 months later, with good results. Four (33%) of 12 patients, five (62%) of eight patients, and two (100%) of two patients were successfully treated with placement of the first stent, the second stent, and the third stent, respectively. In the remaining patient, the second stent remains in place. CONCLUSION: Placement of a covered, retrievable, expandable nitinol stent seems to be effective in treating urethral strictures near the external sphincter and warrants further investigation.     

Removal of retrievable self-expandable urethral stents: experience in 58 stents

The purpose of this study was to retrospectively evaluate the safety and efficacy of removing retrievable self-expandable urethral stents using a retrieval hook wire. Under fluoroscopic guidance, the removal of 58 polyurethane or PTFE (polytetrafluoroethylene)-covered stents was attempted in 33 patients using a retrieval hook wire. Indications for removal were elective removal (n=21), stent migration (n=19), formation of tissue hyperplasia around or inside of the stent (n=14), stent deformity (n=3), and severe pain (n=1). The mean time the stents remained in place was 64.8±42.9 days (range, 1–177 days). Fifty-six (97%) of the 58 stents were successfully removed using the retrieval hook wire despite the following difficulties; hook wire disconnection (n=2), untied drawstrings (n=3), and polyurethane membrane disruption/separation (n=4). The removal procedure using a retrieval hook wire failed in two stents (3%) which had migrated into the urinary bladder. One of the two stents with migration into the urinary bladder was removed using a snare through the cystostomy route. The overall complication rate was 14% (seven hematuria cases and one urethral tear case), and all were minor and spontaneously resolved without further treatment. In conclusion, removal of retrievable urethral stents using a retrieval hook wire was safe and effective despite some technical difficulties. It is a useful method for allowing temporary stent placement and solving various complications of stent use.