Polyflex Stent Research Articles

Tracheobronchial stent sizing and deployment practices airway stenting practices around the world: a survey study.

BackgroundTracheobronchial stents types, uses, techniques for deployment and extraction have practice variations around the world.MethodsWe collected responses by sending an online survey of 8 questions to world interventional bronchology member societies and social media groups.ResultsThere were 269 respondents from 47 countries. Europe had 97 respondents from 22 countries. There were 8 respondents from Australia, 7 from Africa (3 countries) and 7 from 4 countries in South America (SA). North America (NA) had 72 respondents from 3 countries. Asia had 78 respondents from 14 countries. For stent placements 15% [41] used fiberoptic bronchoscope (FB) only. Rigid bronchoscopy (RB) was solely utilized by 38% [102]. Forty-six percent [123] used a combination of RB and FB (P value <0.00001). For stent extraction 13% [19] used FB alone, 57% [85] used RB, and 36% [54] used a combination of RB and FB (P value <0.00001). Placement of stents were 50.5% [135] only by direct visualization. Twenty-three percent [61] always used fluoroscopic guidance. Twenty-six-point-five percent [71] used fluoroscopy in certain cases (P value <0.00001). Sixty percent [162] decided stent sizing by measurements of stenotic and non-stenotic areas on radiology. Twelve percent [32] respondents used sizing devices. Sixty-five percent [177] used a ruler and bronchoscope to measure stenotic areas. Thirty-eight percent [104] used visual estimation and experience. Seven percent [19] used serial balloon dilatation size. To prevent clogging of stents, 22% [59] prescribed mucolytics. Seventy-three percent [195] nebulized saline, 26% [70] had Mucomyst Nebulization, 24% [65] Nebulized bronchodilators and other methods 11% [30] were advised. Covered self-expandable metal stents (SEMS) 44% was the commonest type of stent used around the world. Silicone stents 37%, Y stents 15%, uncovered SEMS 12%, Montgomery T tube 5% followed. Polyflex stents 3% and custom-made stents 3% were least used. Biodegradable stents were used by 7.5%, and not used by 92.5%.ConclusionsTracheobronchial stent practice norms have slowly evolved, but its practice variations lack uniformity, and have sparse evidence-based studies for its direction.

1724 Acquired Broncho-Esophageal Fistula After 10 Years of Esophageal Stent Placement

INTRODUCTION: Acquired benign Broncho-esophageal fistulas (BEF) are uncommon and develops as a complication of inflammatory processes, malignant neoplasm and traumas of the chest but it has been rarely reported with esophageal or tracheal stents. We are reporting a case of Lt BEF after 10 years of esophageal stent placement for recurrent benign esophageal stricture. CASE DESCRIPTION/METHODS: A 52 years-old-female with history of HIV-1 infection was admitted with dysphagia to solid food. Her condition started 10 years ago after she presented with progressive odynophagia and dysphagia to solids and liquids. EGD at that time showed giant aphthous esophageal ulcer, 25 to 34 cm from the incisors, involving entire esophageal circumference. Biopsy showed ulcerated squamous mucosa with diffuse acute and chronic inflammation, negative stains for acid fast bacilli, fungal infection, CMV and HSV. She was treated with pantoprazole, hydrocortisone and thalidomide without improvement of her symptoms. Repeated EGD showed formation of benign esophageal stricture with negative repeated biopsy results. Over 6 months, she underwent multiple balloon dilatation of the stricture until 16 to 20 mm × 120 mm in length, Polyflex stent was placed with improvement of her symptoms She was lost for follow up before presenting again with progressive dysphagia to solids of 3 months duration associated with progressive weight loss. Esophagogram showed stable position of the stent in the mid esophagus with stable dilated proximal esophagus and no esophageal stricture. Due to concern of stent malfunction, the stent was removed but the patient continued to have dysphagia. Repeated esophagogram four days later, showed contrast media in the Left main bronchus tracking to the left lower lung lobe. Bronchoscopy and upper endoscopy showed chronic acquired Broncho-esophageal fistula extending from the lateral edge of membranous left main bronchus to the esophagus, 25 cm from incisors. PEG tube was placed for nutrition and she is planned for fistula repair in two weeks. DISCUSSION: BEF is a serious condition and treatment is mandatory to avoid continuous aspiration, chronic sepsis, and pulmonary failure, mainly in immunocompromised patients. There are no studies on the incidence of such fistulas after esophageal stent placements. On the other hand, some studies favored tracheal or esophageal stents as a corrective measure, although neither are free from complications, and they are palliative measures, making surgical repair the best option.

Use of self-expandable plastic stents (SEPS) in management of refractory benign esophageal strictures: a single center experience

Back ground Benign esophageal stricture is a common cause for dysphagia in adults. It can negatively affect the quality of patient’s life and may cause many complications. Benign esophageal strictures are caused by different procedures and disorders, such as gastroesophageal reflux disease, post-surgery anastomotic stricture, radiation, ablative therapy or caustic ingestion. The aim of the study was to assess the efficacy of Polyflex stent insertion in refractory benign esophageal strictures in patients admitted to the endoscopy unit of the Medical Research Institute hospital, Alexandria University, Alexandria, Egypt.

A prospective trial comparing two types of self-expanding stents in the palliation of malignant dysphagia: SEMS (Wallflex stent) versus SEPS (Polyflex stent)

A prospective trial comparing two types of self-expanding stents in the palliation of malignant dysphagia: SEMS (Wallflex stent) versus SEPS (Polyflex stent)

A Safe Method of Tracheal Polyflex Stent Placement: A Review of 20 Patients.

Background:Surgery is an appropriate therapeutic approach for tracheal stenosis due to various benign and malignant conditions. When surgery is postponed for certain reasons, other options are chosen for airway patency. One alternative is using airway stents.Objectives:We aimed to introduce a safe method of tracheal polyflex stent placement in patients with tracheal stenoses.Patients and Methods:During a 7-year period (2002 - 2008), polyflex stents were used 29 times among 20 patients for various indications. After encountering many difficulties in earlier cases, we gradually developed our new method and used it in most of our patients. In this method, without using large rigid bronchoscopes, the introducer tube could be used as a bronchoscope with the aid of a zero-degree lens and ventilating apparatus. In this method, the rate of possible trauma to the airway can be minimized by avoiding the use of thick rigid bronchoscopies and the stent can be placed faster and more accurately.Results:Polyflex stents were used in 11 men (55%) and 9 women with a mean age of 38.5 years. Stents were removed and changed in 12 cases and replaced with another type of stent in 3 patients. Indications were recurrence of tracheal stenosis (7), multisegmental tracheal stenosis (3), anesthesia limitations (3), tracheal tumors (2), dehiscence of tracheal anastomosis (1), severe inflammation of the tracheal mucosa (1), esophagobronchial fistula (1), and external pressure on the left main bronchus (1). In one patient, a stent was used to open a kinked Dumon stent as a temporary life-saving procedure. We found 6 cases of stent migration, 3 cases of granulation tissue formation, 1 case of infection, and 1 case of surgical site dehiscence.Conclusions:Stents would be regarded as a temporary means of reaching the ideal condition for resection and reconstruction in most patients with tracheal stenoses. Although an optimal stent has not been introduced yet, we used polyflex stents in most of our patients with tracheal stenosis due to its availability and ease of use. We suggest that this method is safe and less time consuming than its traditional method of placement.

SU-E-T-115: Dose Perturbation Study of Self-Expandable Metal and Polyester Esophageal Stents in Proton Therapy Beams

Purpose: This work investigates dose perturbations due to Self-expandable metal and polyester esophageal stents undergoing proton radiotherapy for esophageal cancer. Methods: Five commercially available esophageal stents made of nitinol (Evolution, Wallflex and Ultraflex), stainless steel (Z-Stent) and polyester (Polyflex) were tested. Radiochromic film (GafChromic EBT3 film, Ashland, Covington, KY) wrapped around a stent and a 12cc syringe was irradiated with 2CGE (Cobalt Gray Equivalent) of proton beam in a custom fabricated acrylic phantom. An air-hollow syringe simulates the esophagus. Results: The Z-stent created the largest dose perturbations ranges from -14.5% to 6.1% due to the steel composition. The WallFlex, Evolution and Ultraflex stents produced the dose perturbation ranges of (−9.2%∼8.6%), (−6.8%∼5.7%) and (−6.2%∼6.2%), respectively. The PolyFlex stent contains the radiopaque tungsten markers located top, middle and bottom portions. When the focal cold spots induced by the markers were excluded in the analysis, the dose perturbation range was changed from (−11.6%∼6.4%) to (−0.6%∼5.0%). Conclusion: The magnitude of dose perturbation is related to material of a metallic stent. The non-metallic stent such as PolyFlex shows relatively lower dose perturbation than metallic stents except a radiopaque marker region. Overall Evolution and Ultraflex stent appear to be less dose perturbations. The largest dose perturbationsmore » (cold spots) were located at both edges of stents in distal area for the single proton beam irradiation study. The analysis of more than two proton beam which is more typical clinical beam arrangement would be necessary to minimize the doe perturbation effect in proton ratiotherapy.« less

The Role of Tracheal Stenting As an Alternative Treatment in Cicatricial and Non-Operable Tracheal Stenosis

Introduction: Tracheal stenosis is normally caused by trauma, infection, benign and malignant tumors, prolonged intubation or tracheostomy. The best treatment for tracheal stenosis is resection and anastomosis of trachea. Yet the major surgical complication of tracheal surgery is postoperative stenosis. The goal of this paper is to study the result of tracheal stenting as a replacement therapy for patients suffering from tracheal stenosis who are not good candidates for surgery. Materials and Methods: This study presents the results of stenting in patients with: Inoperable tumoral stenosis,Non-tumoral stenosis being complicated due to prior surgeries,Inability to undergo a major surgery.The study was performed between September 2002 and July 2011 and poly flex stents were used by means of rigid bronchoscopy. Results: A total of 25 patients received stents during this study. Among them 15 patients suffered from benign and 10 suffered from malignant tracheal stenosis. The patients were followed up for at most 12 months after the stenting operation. The mean age of the patients was 35 years. The most common cause of stenosis was prolonged intubation (75%). The most common indication for stenting was the history of multiple tracheal operations. The most common complication of stenting and cause of stent removal was formation of granulation tissue. 30% of patients with benign tracheal stenosis were cured and about 10% improved until they could stand a major operation. Ten patients in benign group and 2 patients in malignant group (20%) needed T-Tube insertion after stent removal but other patientcure by stenting. Conclusions: In benign cases stenting is associated with recurrence of symptoms which requires other therapeutic techniqus, so the stenting may not be named as a final solution in benign cases. However, this technique is the only method with approved efficacy for malignant cases with indication.

Removable esophageal stents have poor efficacy for the treatment of refractory benign esophageal strictures (RBES)

With the recent availability of removable esophageal stents, endoscopic stenting has been utilized to treat refractory benign esophageal strictures (RBES). The objective of this study was to review the feasibility and effectiveness of removable esophageal stents to treat RBES. Patients who received removable esophageal stents for the treatment of RBES at the institution between 2004-2010 using its stent implantation logs and endoscopic database were retrospectively identified. Patient demographics, stricture etiology and location, stent and procedure characteristics, and clinical outcomes were obtained. Twenty-five patients with a mean age of 70 (72% male) underwent initial stent placement; 24 were successful. Overall clinical success was achieved in five of the 19 patients (26%) ultimately undergoing stent removal. RBES etiologies included anastomotic (13), radiation (5), peptic (3), chemotherapy (1), scleroderma (1), and unknown (2). Alimaxx-E (Merit-Endotek, South Jordan, UT, USA) stents were placed in 20 patients and Polyflex (Boston Scientific, Natick, MA, USA) stents were used in five patients. Immediate complications included failed deployment (1) and chest pain (7). Five patients died prior to stent removal. Stent migration was found in 53% (10/19) of patients who underwent stent removal: nine required additional therapy and one had symptom resolution. Out of the nine patients without stent migration, five required additional therapy and four had symptom resolution. Although placement of removable esophageal stents for RBES is technically feasible, it is frequently complicated by stent migration and chest pain. In addition, few patients achieved long-term stricture resolution after initial stenting. In this study, most patients ultimately required repeated stenting and/or dilations to maintain relief of dysphagia.

Pressure Necrosis for the Removal of Embedded Self Expanding Esophageal Stents: A Rare Treatment for a Common Problem

Purpose: Covered self expandable metallic stents (SEMS) have traditionally been used for the treatment of malignant esophageal obstruction; however, recently they have been employed in the treatment of esophageal fistulas. Partially covered SEMS have been shown to be safe and effective and offer the benefit of decreased migration. However, safe removal is difficult due to tissue hyperplasia at the uncovered ends of the stent leading to its embedment into the esophageal wall. We report a case demonstrating successful removal of a partially covered SEMS by pressure necrosis created from placing a fully covered polyflex stent via a “stent in stent” method. A 64-year-old male was referred to our service after development of an esophageal perforation resulting in pneumonia and pleural effusion secondary to a TEE performed during cardioversion for paroxysmal atrial fibrillation. This arrhythmia occurred after the patient had a gastric sleeve procedure for morbid obesity. The patient had a partially covered SEMS placed with the proximal end above the gastroesophageal junction at 39cm from the incisors. The partially covered stent was initially chosen to help create a tissue seal at both ends of the stent to promote healing and to prevent migration. Tissue overgrowth was seen at the proximal end of the stent, but no tissue hyperplasia was seen at the distal end. The distal end of the stent extended down into the proximal gastric body, and the area of the perforation still appeared to be well covered. A 12 cm long fully covered polyflex stent with a central diameter of 18mm flaring out to 23mm at the ends was then successfully deployed under fluoroscopic guidance inside of the previously placed stent with the proximal end overlapping the proximal end of the previously placed stent by 3cm. We then confirmed endoscopically that the polyflex stent was completely covering the area of tissue overgrowth at the proximal end of the stent. Three weeks later, the patient went for repeat EGD, and the polyflex stent was successfully removed with alligator forceps revealing that nearly all of the tissue overgrowth had resolved at the proximal end of the stent from prior exam due to effective pressure necrosis. We initially were unable to remove the partially covered stent by gripping the proximal end with the alligator forceps, and we eventually had to grip the distal end and employ an eversion technique under fluoroscopic guidance with gentle traction to successfully remove the stent. The stent-in-stent technique is safe and effective for the removal of partially covered SEMS that are embedded into the esophageal wall. We recommend further larger prospective trials to analyze this method for the removal of SEMS.

Polyflex Stent Placement for the Treatment of Benign Esophageal Stricture: A 3 Year Follow-Up with Intact Stent Position

Purpose: Current therapy for benign esophageal strictures includes dilation as well as esophageal stents, such as self-expandable metal or plastic stents (SEPS). These endoprostheses have been shown to improve symptoms of dysphagia, but have known complications, such as migration in up to 30% of cases. We report a case of an 80 year old female who presented with a three-year history of refractory benign esophageal stricture, located 37 to 40 cm from the incisors. She complained of dysphagia along with significant weight loss. She had previously undergone frequent dilations in addition to twice daily proton pump inhibitor therapy. Upper endoscopy was performed, and 12 cm × 18 mm Polyflex Esophageal Stent (Boston Scientific, USA) was endoscopically placed under fluoroscopic guidance. The patient reported resolution of dysphagia, and a several pound weight gain. The patient refused stent removal at 3 months due to lack of symptoms. She was thereafter followed bi-monthly, during which she remained asymptomatic. Repeat endoscopy at 6, 11, and 36 months showed an intact stent in position. Polyflex stents (Boston Scientific, USA) are silicone endoprostheses that have been successfully used in relieving symptoms of dysphagia in both benign and malignant strictures. They have been shown to be an effective, longer term option in management of dysphagia as compared to serial dilatation in select individuals with refractory benign esophageal strictures. These stents are usually removed 4-8 weeks after placement, and manufacturer recommendation is removal after 9 months. Our patient refused stent removal, and was therefore followed serially without complications for 3 years to date. SEPS are an effective treatment of benign esophageal strictures, and may be safely used for durations longer than the recommended time.

Tracheobronchial Polyflex stents for the management of benign refractory hypopharyngeal strictures

To describe a modified technique for placement of a tracheobronchial self-expanding plastic stent (SEPS) in patients with benign refractory hypopharyngeal strictures in order to improve dysphagia and allow stricture remodeling. A case series of four consecutive patients with complex hypopharyngeal strictures after combined therapy for laryngeal cancer, previously submitted to multiple sessions of dilation without lasting improvement, is presented. All patients underwent placement of a small diameter and unflared tracheobronchial SEPS. Main outcome measurements were improvement of dysphagia and avoiding of repeated dilation. The modified introducer system allowed an easy and technically successful deployment of the tracheobronchial Polyflex stent through the stricture. All four patients developed complications related to stent placement. Two patients had stent migration (one proximal and one distal), two patients developed phanryngocutaneous fistulas and all patients with stents in situ for more than 8 wk had hyperplastic tissue growth at the upper end of the stent. Stricture recurrence was observed at 4 wk follow-up after stent removal in all patients. Although technically feasible, placement of a tracheobronchial SEPS is associated with a high risk of complications. Small diameter stents must be kept in place for longer than 3 mo to allow adequate time for stricture remodeling.

The Use of Self-Expanding Plastic Stents in the Management of Oesophageal Leaks and Spontaneous Oesophageal Perforations

Leakage after oesophageal anastomosis or perforation remains a challenge for the surgeon. Traditional management has been operative repair or intensive conservative management. Both treatments are associated with prolonged hospitalisation and high morbidity and mortality rates. Self-expanding metallic stents have played an important role in the palliation of malignant oesophageal strictures and the treatment of tracheoesophageal fistulae. However, self-expanding metal stents in benign oesophageal disease are associated with complications such as bleeding, food bolus impaction, stent migration, and difficulty in retrieval. The Polyflex stent is the only commercially available self-expanding plastic stent which has been used in the management of malignant oesophageal strictures with good results. This review will consider the literature concerning the use of self-expanding plastic stents in the treatment of oesophageal anastomotic leakage and spontaneous perforations of the oesophagus.

Radiotherapy Dose Perturbation of Esophageal Stents Examined in an Experimental Model

To investigate the radiotherapy dose perturbations caused by esophageal stents in patients undergoing external beam treatments for esophageal cancer. Four esophageal stents were examined (three metallic stents: WallFlex, Ultraflex, and Alveolus; one nonmetallic stent with limited radiopaque markers for visualization: Polyflex). All experiments were performed in a liquid water phantom with a custom acrylic stent holder. Radiochromic film was used to measure the dose distributions adjacent to the stents at locations proximal and distal to the radiation source. The stents were placed in an air-filled cavity to simulate the esophagus. Treatment plans were created and delivered for photon energies of 6 and 15 MV, and data analysis was performed on uniform regions of interest, according to the size and geometric placement of the films, to quantify the dose perturbations. The three metallic stents produced the largest dose perturbations with distinct patterns of "hot" spots (increased dose) measured proximal to the radiation source (up to 15.4%) and both "cold" (decreased dose) and hot spots measured distal to the radiation source (range, -6.1%-5.8%). The polymeric Polyflex stent produced similar dose perturbations when the radiopaque markers were examined (range, -7.6%-15.4%). However, when the radiopaque markers were excluded from the analysis, the Polyflex stent produced significantly smaller dose perturbations, with maximum hot spots of 7.3% and cold spots of -3.2%. The dose perturbations caused by esophageal stents during the treatment of esophageal cancer using external beam radiotherapy should be understood. These perturbations will result in hot and cold spots in the esophageal mucosa, with varying magnitudes depending on the stent. The nonmetallic Polyflex stent appears to be the most suitable for patients undergoing radiotherapy, but further studies are necessary to determine the clinical significance of the dose perturbations.

Esophageal stents for benign refractory strictures: a meta-analysis

Fully covered self-expanding removable stents (SERS) have been considered a viable alternative to serial bougienage. The primary aim of this meta-analysis was to determine the efficacy of SERS for refractory esophageal strictures. Medline, Embase, and PubMed databases were searched using the keywords "esophageal stricture," "esophageal stents," "benign stricture," "dysphagia," "caustic," "peptic stricture," "anastomotic," "radiation," and "dysphagia" for the period from January 1965 to June 2010. Articles were selected for review independently by two authors (T. T. and J. M.) on the basis of predefined inclusion criteria, and the data collected. A meta-analysis using a random effects model was done. Eight studies with a total of 199 patients were included in the final analysis (104-males, average age 56 years, range: 49 - 68 years). Overall, 46.2 % of patients (95 %CI: 38.3 % - 54.1 %) had dysphagia improvement at an average follow up of 74 weeks. There was a significant difference ( P = 0.019) in dysphagia improvement for patients with Polyflex stents (55.3 %; 95 %CI: 44.4 % - 65.9 %) versus nitinol stents (21.8 %; 95 %CI: 13.7 % - 33.7 %). On meta-regression, patient sex ( P = 0.80), patient age ( P = 0.725), corrosive etiology ( P = 0.30), stricture location ( P = 0.273), stricture length ( P = 0.32), time of removal ( P = 0.056), and duration of follow-up (0.35) had no significance influence on the outcome. The migration rate was 26.4 % (95 %CI: 25.3 % - 39.3 %). Although the efficacy of SERS placement in benign refractory strictures is 46.2 %, it is associated with migration rate of 26.4 %. Nevertheless, the use of these temporary stents, which can be successfully removed in 87 % of patients, is an alluring prospect for treating patients with this difficult condition.

Esophageal Stenting for Leaks and Strictures: A Benign Intervention for a Benign Indication?

As esophageal stents have evolved in composition, so alsohave indications for their placement [1]. Stents wereavailable initially only as rigid plastic or rubber stents, usedfor the treatment of malignant dysphagia. This rigid designresulted in difficult placement and frequent complications.In response to this, self-expanding metal stents (SEMS)were developed. Although better tolerated and easier toplace, these stents were plagued by tissue ingrowth throughtheir open mesh. In response to this, a covering membranewas added to stents to minimize tissue ingrowth. While apartially covered stent is sufficient to prevent tumoringrowth and occlude esophageal fistulas in malignantdysphagia, this design was inadequate for benign indica-tions due to concerns for the stent becoming imbedded atits distal and proximal uncovered ends with in some casesformation of new strictures [2].More recently, fully covered stents have been availableand have been used in a variety of benign indications(Table 1). The most widely studied stent is the Poly-flex stent (Boston Scientific, Natick, MA, USA), a self-expanding plastic stent (SEPS) which was introduced in2001 and remains the only stent with FDA approval for lateremovability. The Alimaxx-E stent (Merit Endotek, SouthJordan, UT, USA), used in the current study by Senousyand colleagues, was introduced in 2005. It is a hybrid fullycovered self-expanding metal stent (FCSEMS) constructedof nitinol and fully covered with polyurethane, with 20outer metal struts to resist migration. Although thisFCSEMS is only FDA-approved for immediate removal,the ability to resist tissue ingrowth has led to its use inbenign indications with a delayed removal. More recently,other esophageal FCSEMSs have become available in theUnited States but none are approved for delayed removal(Table 1).In this issue, Senousy and colleagues report on theirexperience using the Alimaxx-E stent for benign esophagealindications. In a retrospective study conducted over a 6-yearperiod, 14 patients were treated in total for esophageal fis-tulas (n = 7) and benign esophageal strictures (BES, n = 7)[3]. Given the important clinical differences between thesetwo groups, it is best to consider them separately.A heterogeneous group of difficult benign strictureswere treated in this study, including strictures due toradiation therapy, photodynamic therapy, post-surgicalanastomosis, and peptic disease. Impressively, all patientshad clinical resolution of their dysphagia after this short-term intervention; however, it is important to note thatlong-term follow-up in this retrospective study was notstandardized. Thus, despite this positive result, a majorconcern is the durability of this effect, as many of thesedifficult strictures may recur late after stent removal [4, 5].In a recently published study of 31 patients with the sameFCSEMS placement, stent placement was performed for arefractory BES in 7 patients [6]. With 6 months follow-upafter stent placement, stricture resolution was seen in only29% of patients. A recently published prospective study of40 patients with rigorous follow-up utilized a SEPS whichwas removed 4 weeks after initial placement. A similarlypoor long-term success rate (30%) was seen at 1 year forthese patients with refractory BES [7].A difficulty in studying interventions for patients withBES is the lack of a uniform definition. Recently, criteriahave been proposed to facilitate discussion about man-agement of difficult benign esophageal strictures, andwidespread adoption should be considered [8]. In this

SU‐GG‐T‐319: Effects of Esophageal Stents on Radiotherapy Dose Perturbation Examined in an Experimental Model

Purpose: To investigate the radiotherapy dose perturbations caused by esophageal stents in patients undergoing x‐ray beam therapy for esophageal cancer. Method and Materials: Four experimental esophageal stents from Boston Scientific were examined (three metallic stents: Wallflex, Ultraflex and Alimaxx, and one polymeric stent with limited radiopaque markers for visualization: Polyflex). All experiments were performed in a water phantom with a custom acrylic stent holder in order to closely model the scatter and absorption characteristics of human soft tissue. Gafchromic film was used to measure the dose distributions at locations above and below the stents, which were placed in an air‐filled cavity to simulate the esophagus. Treatment plans were created and delivered for clinically relevant photon energies of 6 and 15 MV, and data analysis was performed on uniform regions of interest to quantify the dose perturbations. Results: The three metallic stents produced the largest dose fluctuations with distinct patterns of ‘hot’ spots (increased dose) measured above the stents (up to +15.4%) and both ‘cold’ (decreased dose) and ‘hot’ spots measured below the stents (range: −6.2 to +5.4%). The polymeric Polyflex stent produced similar dose alterations when the radiopaque markers were examined (range: −6.4 to +15.4%). However, when the markers were excluded from the analysis, the Polyflex stent produced significantly smaller dose fluctuations, with maximum ‘hot’ spots of +6.8% and cold spots of −2.5%. Minimal energy dependence was observed. Conclusion: The non‐metallic Polyflex stent appears to be the most suitable for patients undergoing radiotherapy. The radiopaque markers would facilitate precise localization in the esophagus, while the polymeric composition would have the least affect on the dose distribution within the treatment volume. More work needs to be performed to determine the clinical significance of the observed ‘hot’ and ‘cold’ spots but is beyond the scope of this study.

Solving the Problem of Difficult Stent Removal Due to Tissue Ingrowth in Partially Uncovered Esophageal Self-Expanding Metal Stents

Partially uncovered stents provide a better fixation to the esophageal wall than fully covered stents, but indication is limited to palliation because stent removal is compromised by mucosal ingrowth. After an unsuccessful attempt to remove a partially uncovered Evolution stent (Cook Medical Inc, Bloomington, IN) we placed a Polyflex stent (Boston Scientific, Natick, MA) inside the first stent, overlapping at the lower part to press the tissue out of the stent mesh. Both stents were easily removed 3 days later. By adopting this procedure to scheduled stent removals, partially uncovered SEMS may be used to prevent the frequently observed migrations of fully-covered stents in the treatment of esophageal perforation or anastomotic leakage.

High pharyngoesophageal strictures after laryngopharyngectomy can also be treated by self-expandable plastic stents

Permanent dysphagia occurring after laryngectomy or laryngopharyngectomy can usually be treated by periodic dilation. Occasionally, however, conservative treatment is insufficient, and patients require long-term tube feeding. We describe 4 cases with stricture after laryngopharyngectomy who underwent insertion of self-expandable plastic stents (SEPSs) across the stricture for treatment of dysphagia. The aim of this study was to evaluate the role of SEPSs in postlaryngopharyngectomy strictures. An interventional study of management of 4 patients of dysphagia after laryngopharyngectomy with SEPSs. Medical gastroenterology unit in a tertiary care hospital. Four patients with dysphagia after laryngopharyngectomy. SEPS placement and removal after 3 months. Improvement in dysphagia. Four patients with dysphagia after laryngopharyngectomy underwent dilation of stricture followed by SEPS placement for 3 months. Three patients had grade IV, and 1 grade III dysphagia. Endoscopy showed stricture at 10 to 14 cm from the incisors. Stricture was dilated up to 15 mm on 3 occasions, 2 weeks apart. A silicone Polyflex stent was placed across the stricture and removed after 3 months. No dysphagia recurred after 2 months. No significant complications were noted. Small sample size. SEPSs dilate postlaryngopharyngectomy strictures and prevent restenosis even after removal.

T1582: The Use of Polyflex Stents in the Management of Complicated Esophageal Diseases

Polyflex stents are removable, self-expanding, plastic stents (RSEPS) that are indicated for the treatment of malignant and benign esophageal strictures. However, they can also play an important role in the treatment of iatrogenic esophageal perforations and post-surgical anastomotic leaks by avoiding the need for surgical intervention in complicated cases. We report our experience at Georgetown University Hospital with the Polyflex esophageal stent in the treatment and management of complicated esophageal diseases.We retrospectively examined records of all pts who underwent placement of a Polyflex esophageal stent between 2004 to 2009. Patient demograhics, procedure indication, endoscopic findings, and subsequent follow-up (imaging, endoscopy and clinic) were analyzed. A successful outcome was defined as no further need for surgical or alternative endoscopic interventions and ability of the patient to tolerate oral intake. Complications were defined as chest discomfort requiring removal of the stent, stent migration, bleeding, GERD, and death.A total of 22 stents were placed in 14 pts(8 males and 6 females) with a mean age of 57 years (range, 36-83 years). Indication for stent placement were 9 for post-surgical anastomotic leak and 5 for perforations. The mean follow-up was 3 months. Stent deployment was successful in all patients. There was one patient with an unsuccessful outcome. The patient had a persistent leak despite insertion of multiple stents that required use of a fibrin sealant. However, this patient had a significant defect that was decreased by about 90% after placement of a Polyflex stent which then allowed for further treatment with the fibrin sealant. A total of 4 pts had complications following the procedure. The first patient had complicated medical issues and care was withdrawn and he subsequently died. Stent migration was noted in 3 patients. However, in these three patients the migrated stent was seen on follow-up imaging with resolution of the mucosal defect.Esophageal perforations and post-surgical anastomotic leaks can be managed endoscopically with placement of RSEPS with continued aggressive medical and endoscopic care. In our institution, this has become the initial treatment modality for complicated esophageal diseases where a team approach that includes endoscopists and thoracic surgeon is used. This practice is not only safe and effective but decreases the need for surgery, post-operative care, and length of hospital stay—all of which lead to improved patient satisfaction. In high risk surgical candidates this is an invaluable option when mortality from surgery or from lack of intervention would be inevitable.

Clinical Outcomes After Self-Expanding Plastic Stent Placement for Refractory Benign Esophageal Strictures

Refractory benign esophageal strictures (RBES) are defined as those that persist structurally and symptomatically after repeated dilation sessions. Small series have reported favorable outcomes after placement and subsequent removal of Polyflex self-expanding plastic stents (SEPS). To characterize the outcomes after Polyflex stent placement in patients with RBES. Outcomes of consecutive patients who underwent Polyflex stent placement for RBES between April 15, 2005 and November 20, 2006 were analyzed retrospectively. The etiology of the stricture, number of dilations prior to initial SEPS placement, size of stent placed, stricture resolution after SEPS removal, cases of stent migration, duration of SEPS placement, time to repeat dilation and/or SEPS replacement after stent removal, and complications were assessed. Twenty-three Polyflex stents were placed in 13 patients suitable for analysis. The majority of stenoses (11/13) were attributable to anastomotic strictures after curative esophagogastrectomy for esophageal neoplasms. All 11 patients in this group had satisfactory relief of dysphagia to solids determined clinically with indwelling SEPS placement. SEPS migration occurred in seven instances (30% of SEPS placed). Dysphagia remediation after subsequent SEPS removal was observed in only three patients (23%). Placement of a partially covered metal stent within a Polyflex stent was necessary in one case due to epithelial hyperplasia. The mean time for repeat dilation and/or SEPS reinsertion due to recurrent dysphagia after stent removal was 37 days (range 6-120 days). Polyflex stents provided satisfactory palliation of dysphagia for RBES while in place. However, unplanned SEPS migration and dysphagia recurrence after stent removal were common.