Placement of a Newly Designed Y-Configured Bilateral Self-Expanding Metallic Stent for Hilar Biliary Obstruction: A Pilot Study.

PubMed

Jiao, Dechao; Huang, Kai; Zhu, Ming; Wu, Gang; Ren, Jianzhuang; Wang, Yanli; Han, Xinwei

2017-01-01

Whether unilateral or bilateral drainage should be performed for malignant hilar biliary obstruction remains a matter of debate. Although a Y-stent with a central wide-open mesh facilitates bilateral stent placement, it has its own limitations. This study aims to evaluate the feasibility and efficacy of a newly designed Y-configured bilateral self-expanding metallic stent (SEMS) for the treatment of hilar biliary obstruction. In this retrospective study, 14 consecutive patients with unresectable malignant hilar biliary obstruction (Bismuth type II or higher), who underwent placement of a newly designed Y-configured bilateral SEMS for hilar biliary obstruction from April 2013 to March 2015, were included into this study. Data on technical success, clinical success, stent patency, complications and patient survival were collected. Technical and clinical success was 100 and 92.9 %, respectively. Mean serum bilirubin level was significantly decreased 1 month after stent placement (P < 0.01). Furthermore, two patients (14.3 %) had early complications (one patient had severe hemobilia and one patient had cholangitis), and two patients (14.3 %) had late complications (one patient had cholangitis and one patient had cholecystitis). During the mean follow-up period of 298 days (range 89-465 days), six patients (42.9 %) developed stent occlusion caused by tumor ingrowth or overgrowth (n = 5) and sludge (n = 1). Median stent patency and overall survival times were 281 days (95 % CI 175.9-386.1 days) and 381 days (95 % CI 291.4-470.6 days), respectively. The use of the newly designed Y-configured bilateral SEMS is feasible and effective for hilar biliary obstruction using port docking deployment.

Partial stent-in-stent placement of biliary metallic stents using a short double-balloon enteroscopy.

PubMed

Tsutsumi, Koichiro; Kato, Hironari; Tomoda, Takeshi; Matsumoto, Kazuyuki; Sakakihara, Ichiro; Yamamoto, Naoki; Noma, Yasuhiro; Sonoyama, Takayuki; Okada, Hiroyuki; Yamamoto, Kazuhide

2012-12-07

Endoscopic intervention is less invasive than percutaneous or surgical approaches and should be considered the primary drainage procedure in most cases with obstructive jaundice. Recently, therapeutic endoscopic retrograde cholangiopancreatography (ERCP) using double-balloon enteroscopy (DBE) has been shown to be feasible and effective, even in patients with surgically altered anatomies. On the other hand, endoscopic partial stent-in-stent (PSIS) placement of self-expandable metallic stents (SEMSs) for malignant hilar biliary obstruction in conventional ERCP has also been shown to be feasible, safe and effective. We performed PSIS placement of SEMSs for malignant hilar biliary obstruction due to liver metastasis using a short DBE in a patient with Roux-en-Y anastomosis and achieved technical and clinical success. This procedure can result in quick relief from obstructive jaundice in a single session and with short-term hospitalization, even in patients with surgically altered anatomies.

Primary and revision efficacy of cross-wired metallic stents for endoscopic bilateral stent-in-stent placement in malignant hilar biliary strictures.

PubMed

Lee, T H; Moon, J H; Kim, J H; Park, D H; Lee, S S; Choi, H J; Cho, Y D; Park, S H; Kim, S J

2013-01-01

Endoscopic bilateral drainage for inoperable malignant hilar biliary strictures (HBS) using metal stents is considered to be technically difficult. Furthermore, endoscopic revision of bilateral stenting after occlusion can be challenging. This study was performed to evaluate the long-term efficacy of endoscopic bilateral stent-in-stent placement of cross-wired metallic stents in high-grade malignant HBS and planned endoscopic bilateral revision. A total of 84 patients with inoperable high-grade malignant HBS were enrolled from three academic tertiary referral centers. Two cross-wired metal stents were inserted using a bilateral stent-in-stent placement method. Bilateral endoscopic revision was also performed during follow-up using either identical metal stents or plastic stents. The main outcome measurements were technical and functional success, complications, stent patency, and endoscopic revision efficacy. The technical and clinical success rates of endoscopic bilateral stent-in-stent placement of cross-wired metallic stents were 95.2% (80/84) and 92.9% (78/84), respectively. Median patency (range) and survival were 238 days (10-429) and 256 days (10-1130), respectively. Obstruction of primary bilateral stents occurred in 30.8% (24/78) of patients with functionally successful stent placement. The technical and clinical success rates of planned bilateral endoscopic revision for occluded stents were 83.3% (20/24) and 79.2% (19/24), respectively. For revision, bilateral metallic stents were placed in 11 patients (55.0%); the remaining patients received plastic stents. Palliative endoscopic bilateral stent-in-stent placement of cross-wired metallic stents was effective in patients with inoperable HBS. Revision endoscopic bilateral stenting may be feasible and successful in cases where the primary deployed metal stents are occluded. © Georg Thieme Verlag KG Stuttgart · New York.

Very late stent thrombosis in a bare-metal stent, 9 years after implantation.

PubMed

Almasswary, Adel A

2009-06-01

Very late bare-metal stent thrombosis occurring beyond one year after stenting is uncommon. We report a case of bare-metal stent thrombosis presenting as acute myocardial infarction. The patient's stent was implanted 9 years ago, however, he was not adherent to his antiplatelet therapy (aspirin). This case highlights the importance of antiplatelet therapy in patients with stents even many years after implantation.

Dynamic Y stent fractures in crescentic tracheobronchomalacia.

PubMed

Popilevsky, Frida; Al-Ajam, Mohammad R; Ly, Vanthanh; Sanchez, Lisette Delgado; Cutaia, Michael

2012-07-01

Endobronchial stents have been used occasionally to treat benign conditions such as tracheobronchomalacia (TBM). This report describes a unique case of a patient with crescentic TBM in whom Dynamic Y stent was placed on 2 separate occasions to control symptoms and resulted in identical posterior wall stent fractures within a year of stent placement, both times. A silicone Y stent was substituted for the dynamic stent, and it has been effective in controlling symptoms for 9 months without complications. A literature review of cases of fractured Dynamic Y stents is made and factors affecting the choice of stent type for crescentic TBM are explored.

Fabrication and in vitro deployment of a laser-activated shape memory polymer vascular stent

PubMed Central

Baer, Géraldine M; Small, Ward; Wilson, Thomas S; Benett, William J; Matthews, Dennis L; Hartman, Jonathan; Maitland, Duncan J

2007-01-01

Background Vascular stents are small tubular scaffolds used in the treatment of arterial stenosis (narrowing of the vessel). Most vascular stents are metallic and are deployed either by balloon expansion or by self-expansion. A shape memory polymer (SMP) stent may enhance flexibility, compliance, and drug elution compared to its current metallic counterparts. The purpose of this study was to describe the fabrication of a laser-activated SMP stent and demonstrate photothermal expansion of the stent in an in vitro artery model. Methods A novel SMP stent was fabricated from thermoplastic polyurethane. A solid SMP tube formed by dip coating a stainless steel pin was laser-etched to create the mesh pattern of the finished stent. The stent was crimped over a fiber-optic cylindrical light diffuser coupled to an infrared diode laser. Photothermal actuation of the stent was performed in a water-filled mock artery. Results At a physiological flow rate, the stent did not fully expand at the maximum laser power (8.6 W) due to convective cooling. However, under zero flow, simulating the technique of endovascular flow occlusion, complete laser actuation was achieved in the mock artery at a laser power of ~8 W. Conclusion We have shown the design and fabrication of an SMP stent and a means of light delivery for photothermal actuation. Though further studies are required to optimize the device and assess thermal tissue damage, photothermal actuation of the SMP stent was demonstrated. PMID:18042294

Photodynamic therapy for occluded biliary metal stents

NASA Astrophysics Data System (ADS)

Roche, Joseph V. E.; Krasner, Neville; Sturgess, R.

1999-02-01

In this abstract we describe the use of photodynamic therapy (PDT) to recanalize occluded biliary metal stents. In patients with jaundice secondary to obstructed metal stents PDT was carried out 72 hours after the administration of m THPC. Red laser light at 652 nm was delivered endoscopically at an energy intensity of 50 J/cm. A week later endoscopic retrograde cholangiogram showed complete recanalization of the metal stent.

[Numerical modeling of shape memory alloy vascular stent's self-expandable progress and "optimized grid" of stent].

PubMed

Xu, Qiang; Liu, Yulan; Wang, Biao; He, Jin

2008-10-01

Vascular stent is an important medical appliance for angiocardiopathy. Its key deformation process is the expandable progress of stent in the vessel. The important deformation behaviour corresponds to two mechanics targets: deformation and stress. This paper is devoted to the research and development of vascular stent with proprietary intellectual property rights. The design of NiTinol self-expandable stent is optimized by means of finite element software. ANSYS is used to build the finite element simulation model of vascular stent; the molding material is NiTinol shape memory alloy. To cope with the factors that affect the structure of stent, the shape of grid and so on, the self-expanding process of Nitinol stent is simulated through computer. By making a comparison between two kinds of stents with similar grid structure, we present a new concept of "Optimized Grid" of stent.

[Cost-effectiveness trial of self-expandable metal stents and plastic biliary stents in malignant biliary obstruction].

PubMed

Daróczi, Tímea; Bor, Renáta; Fábián, Anna; Szabó, Ella; Farkas, Klaudia; Bálint, Anita; Czakó, László; Rutka, Mariann; Szűcs, Mónika; Milassin, Ágnes; Molnár, Tamás; Szepes, Zoltán

2016-02-14

Self-expandable metal and plastic stents can be applied in the palliative endoscopic treatment of patients with unresectable malignant biliary obstruction. The use of metal stentsis recommended if the patient's life expectancy is more than four months. To compare the therapeutic efficacy and cost-effectiveness of metal and plastic stents in the treatment of malignant biliary obstruction. The authors retrospectively enrolled patients who received metal (37 patients) or plastic stent (37 patients). The complication rate, stent patency and cumulative cost of treatment were assessed in the two groups. The complication rate of metal stents was lower (37.84% vs. 56.76%), but the stent patency was higher compared with plastic stents (19.11 vs. 8.29 weeks; p = 0.0041). In the plastic stent group the frequency of hospitalization of patients in context with stent complications (1.18 vs. 2.32; p = 0.05) and the necessity of reintervention for stent dysfunction (17 vs. 27; p = 0.033) were substantially higher. In this group multiple stent implantation raised the stent patency from 7.68 to 10.75 weeks. There was no difference in the total cost of treatment of malignant biliary obstruction between the two groups (p = 0.848). Considering the cost of treatment and the burden of patients the authors recommend self-expandable metal sten timplantation if the life expectancy of patients is more than two months. In short survival cases multiple plastic stent implantation is recommended.

Stent thrombosis with drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis.

PubMed

Palmerini, Tullio; Biondi-Zoccai, Giuseppe; Della Riva, Diego; Stettler, Christoph; Sangiorgi, Diego; D'Ascenzo, Fabrizio; Kimura, Takeshi; Briguori, Carlo; Sabatè, Manel; Kim, Hyo-Soo; De Waha, Antoinette; Kedhi, Elvin; Smits, Pieter C; Kaiser, Christoph; Sardella, Gennaro; Marullo, Antonino; Kirtane, Ajay J; Leon, Martin B; Stone, Gregg W

2012-04-14

The relative safety of drug-eluting stents and bare-metal stents, especially with respect to stent thrombosis, continues to be debated. In view of the overall low frequency of stent thrombosis, large sample sizes are needed to accurately estimate treatment differences between stents. We compared the risk of thrombosis between bare-metal and drug-eluting stents. For this network meta-analysis, randomised controlled trials comparing different drug-eluting stents or drug-eluting with bare-metal stents currently approved in the USA were identified through Medline, Embase, Cochrane databases, and proceedings of international meetings. Information about study design, inclusion and exclusion criteria, sample characteristics, and clinical outcomes was extracted. 49 trials including 50,844 patients randomly assigned to treatment groups were analysed. 1-year definite stent thrombosis was significantly lower with cobalt-chromium everolimus eluting stents (CoCr-EES) than with bare-metal stents (odds ratio [OR] 0·23, 95% CI 0·13-0·41). The significant difference in stent thrombosis between CoCr-EES and bare-metal stents was evident as early as 30 days (OR 0·21, 95% CI 0·11-0·42) and was also significant between 31 days and 1 year (OR 0·27, 95% CI 0·08-0·74). CoCr-EES were also associated with significantly lower rates of 1-year definite stent thrombosis compared with paclitaxel-eluting stents (OR 0·28, 95% CI 0·16-0·48), permanent polymer-based sirolimus-eluting stents (OR 0·41, 95% CI 0·24-0·70), phosphorylcholine-based zotarolimus-eluting stents (OR 0·21, 95% CI 0·10-0·44), and Resolute zotarolimus-eluting stents (OR 0·14, 95% CI 0·03-0·47). At 2-year follow-up, CoCr-EES were still associated with significantly lower rates of definite stent thrombosis than were bare-metal (OR 0·35, 95% CI 0·17-0·69) and paclitaxel-eluting stents (OR 0·34, 95% CI 0·19-0·62). No other drug-eluting stent had lower definite thrombosis rates compared with bare-metal

Functional Self-Expandable Metal Stents in Biliary Obstruction

PubMed Central

Kwon, Chang-Il; Ko, Kwang Hyun; Hahm, Ki Baik

2013-01-01

Biliary stents are widely used not only for palliative treatment of malignant biliary obstruction but also for benign biliary diseases. Each plastic stent or self-expandable metal stent (SEMS) has its own advantages, and a proper stent should be selected carefully for individual condition. To compensate and overcome several drawbacks of SEMS, functional self-expandable metal stent (FSEMS) has been developed with much progress so far. This article looks into the outcomes and defects of each stent type for benign biliary stricture and describes newly introduced FSEMSs according to their functional categories. PMID:24143314

Expandable metallic stents for tracheobronchial stenoses in esophageal cancer.

PubMed

Takamori, S; Fujita, H; Hayashi, A; Tayama, K; Mitsuoka, M; Ohtsuka, S; Shirouzu, K

1996-09-01

Tracheobronchial stenosis in patients with esophageal cancer can be life threatening. Few reports have discussed use of expandable metallic stents for central airway stenoses in patients with esophageal cancer. Twelve patients with esophageal cancer underwent placement of expandable metallic stents for respiratory distress caused by tracheobronchial stricture. Single or double metallic stents were placed in the stenotic airways under fluoroscopic guidance. Improvement in respiratory symptoms and clinical outcome were assessed. Most stenoses were located in the trachea or the left main bronchus. From one to four expandable metallic stents were placed in each stricture site, with immediate relief of respiratory symptoms in 8 patients. One patient with tracheomalacia in alive 3 years after stent placement and another is alive 6 months after stent insertion. The other 10 patients lived from 10 to 70 days (mean; survival, 35 days) after stent placement. Death was due to progression of disease. Although metallic stents are useful for relieving respiratory distress in patients with advanced esophageal cancer, additional therapies should be considered.

Resolution of Metallic Biliary Stent Allergic Reaction After Partial Stent Removal in a Patient with Nickel Sensitivity.

PubMed

Esparaz, Anthony M; Ahmed, Muneeb

2017-07-01

Local and systemic reactions to implanted metallic devices, particularly to those containing nickel, are well documented. Metal ions are released due to exposure of the metal to blood, proteins, other body fluids, and sheer mechanical stress. Metal ions then complex with native proteins and become antigens, which can elicit hypersensitivity reactions. Another case report depicts a specific allergic complication (early stent occlusion) related to metallic biliary stent implantation. We present a case of allergic symptoms, associated with eating, in a patient who developed nickel sensitivity after biliary metal stent placement confirmed by allergic skin testing to the same metallic biliary stent placed one year earlier. Symptoms resolved following partial removal of the non-epithelialized portion of the biliary stent.

Clinical Application of Fully Covered Self-Expandable Metal Stents in the Treatment of Bronchial Fistula.

PubMed

Cao, Ming; Zhu, Qiang; Wang, Wei; Zhang, Tian Xiao; Jiang, Min Zhong; Zang, Qi

2016-09-01

Background The study was designed to access the feasibility, safety, and efficacy of fully covered self-expandable metal stents in the treatment of bronchial fistula. Methods Clinical data of nine patients (seven males and two females) who were treated with placement of tracheobronchial or bronchial fully covered self-expandable metal stents from August 2005 to November 2011 were analyzed retrospectively. Among these patients, seven were diagnosed with bronchopleural fistula, one with tracheopleural fistula, and one with left main bronchoesophageal fistula. Eight had accompanying thoracic empyema. The fistula orifices ranged from 3.5 mm to 25 mm in diameter. All patients received topical anesthesia. L-shaped stents were placed in six patients and I-shaped stents in three under fluoroscopic guidance. After stent placement, patients with empyema were treated with pleural lavage. Results Stent placement in the tracheobronchial tree was successful in all patients, without procedure-related complications. The operating time was 5 to 16 minutes. A small amount of bubble overflowed from the intrathoracic drainage tube of only one patient. In the other patients, the bubble in the intrathoracic drainage tube disappeared immediately or angiography showed no overflow of contrast agent from the fistula orifice. The effective rate of fistula orifice closure after stent placement was 100%, with 88.9% rated as excellent. One patient coughed the stent out 5 days after placement and hence a new stent was placed. Among the patients with empyema, one died of septicemia arising from empyema on day 8 and another died of brain metastases of lung cancer 6 months after stent insertion with persistent empyema. In the other six patients, empyema resolved after 2 to 5 months (cure rate 75%). Seven patients were followed up for 3 to 36 months. During follow-up, one stent was removed 8 months after implantation due to difficult expectoration, without recurrent empyema. The remaining

A practical method to rapidly dissolve metallic stents.

PubMed

Bradshaw, Scott H; Kennedy, Lloyd; Dexter, David F; Veinot, John P

2009-01-01

Metallic stents are commonly used in many clinical applications including peripheral vascular disease intervention, biliary obstruction, endovascular repair of aneurysms, and percutaneous coronary interventions. In the examination of vascular stent placement, it is important to determine if the stent is open or has become obstructed. This is increasingly important in the era of drug-eluting stent usage in coronary arteries. We describe a practical, rapid and cost-effective method to dissolve most metallic stents leaving the vascular and luminal tissues intact. This practical method may replace the laborious and expensive plastic embedding methods currently utilized.

Current Status of Biliary Metal Stents

PubMed Central

Nam, Hyeong Seok; Kang, Dae Hwan

2016-01-01

Many advances have been achieved in biliary stenting over the past 30 years. Endoscopic stent placement has become the primary management therapy to relieve obstruction in patients with benign or malignant biliary tract diseases. Compared with plastic stents, a self-expandable metallic stent (SEMS) has been used for management in patients with malignant strictures because of a larger lumen and longer stent patency. Recently, SEMS has been used for various benign biliary strictures and leaks. In this article, we briefly review the characteristics of SEMS as well as complications of stent placement. We review the current guidelines for managing malignant and benign biliary obstructions. Recent developments in biliary stenting are also discussed. PMID:26911896

Impact of stent strut design in metallic stents and biodegradable scaffolds.

PubMed

Foin, Nicolas; Lee, Renick D; Torii, Ryo; Guitierrez-Chico, Juan Luis; Mattesini, Alessio; Nijjer, Sukhjinder; Sen, Sayan; Petraco, Ricardo; Davies, Justin E; Di Mario, Carlo; Joner, Michael; Virmani, Renu; Wong, Philip

2014-12-20

Advances in the understanding of healing mechanisms after stent implantation have led to the recognition of stent strut thickness as an essential factor affecting re-endothelialization and overall long term vessel healing response after Percutaneous Coronary Interventions (PCI). Emergence of Drug-eluting stents (DESs) with anti-proliferative coating has contributed to reducing the incidence of restenosis and Target Lesion Revascularization (TVR), while progress and innovations in stent materials have in the meantime facilitated the design of newer platforms with more conformability and thinner struts, producing lesser injury and improving integration into the vessel wall. Recent advances in biodegradable metal and polymer materials now also allow for the design of fully biodegradable platforms, which are aimed at scaffolding the vessel only temporarily to prevent recoil and constrictive remodeling of the vessel during the initial period required, and are then progressively resorbed thereby avoiding the drawback of leaving an unnecessary implant permanently in the vessel. The aim of this article is to review recent evolution in stent material and stent strut design while understanding their impact on PCI outcomes. The article describes the different metallic alloys and biodegradable material properties and how these have impacted the evolution of stent strut thickness and ultimately outcomes in patients. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Metallic stents for tracheobronchial pathology treatment.

PubMed

Serrano, Carolina; Laborda, Alicia; Lozano, Juan M; Caballero, Hugo; Sebastián, Antonio; Lopera, Jorge; de Gregorio, Miguel Ángel

2013-12-01

To present the 7-year experience of the treatment of benign and malignant tracheobronchial stenoses using metallic stents. One hundred twenty-three stents were inserted in 86 patients (74 benign and 12 malignant stenoses). Ninety-seven stents were placed in the trachea and 26 in the bronchi. The procedures were performed under fluoroscopic and flexible bronchoscopic guidance with the patient under light sedation. In cases of severe stenotic lesions or obstructions, laser resection was performed before stent placement. Clinical and functional pulmonary data were recorded before and 3 months after the procedure. Follow-up involved clinical data and radiographic techniques at 48 h and at 1-, 3-, 6-, and 12-month intervals. The technical success was 100 %. Dyspnea disappearance, forced expiratory volume in the first second, and pulmonary functional data improvement was observed in all patients (p < 0.001). Complications were detected in 23 patients (26.7 %). Mean follow-up time was 6.3 ± 1.2 months in patients with malignant lesions and 76.2 ± 2.3 months patients with in benign lesions. By the end of the study, 100 % of patients with malignant pathology and 6.7 % of patients with benign lesions had died. Endoluminal treatment of tracheobronchial stenosis with metallic stents is a therapeutic alternative in patients who are poor candidates for surgery. In unresectable malignant lesions, the benefit of metallic stenting is unquestionable. In benign lesions, the results are satisfactory, but sometimes other interventions are required to treat complications. New stent technology may improve these results.

Metallic Stents for Tracheobronchial Pathology Treatment

DOE Office of Scientific and Technical Information (OSTI.GOV)

Serrano, Carolina, E-mail: carolina.serrano@unizar.es; Laborda, Alicia, E-mail: alaborda@unizar.es; Lozano, Juan M., E-mail: juamauloz@gmail.com

2013-12-15

Purpose: To present the 7-year experience of the treatment of benign and malignant tracheobronchial stenoses using metallic stents. Patients and Methods: One hundred twenty-three stents were inserted in 86 patients (74 benign and 12 malignant stenoses). Ninety-seven stents were placed in the trachea and 26 in the bronchi. The procedures were performed under fluoroscopic and flexible bronchoscopic guidance with the patient under light sedation. In cases of severe stenotic lesions or obstructions, laser resection was performed before stent placement. Clinical and functional pulmonary data were recorded before and 3 months after the procedure. Follow-up involved clinical data and radiographic techniquesmore » at 48 h and at 1-, 3-, 6-, and 12-month intervals. Results: The technical success was 100 %. Dyspnea disappearance, forced expiratory volume in the first second, and pulmonary functional data improvement was observed in all patients (p < 0.001). Complications were detected in 23 patients (26.7 %). Mean follow-up time was 6.3 {+-} 1.2 months in patients with malignant lesions and 76.2 {+-} 2.3 months patients with in benign lesions. By the end of the study, 100 % of patients with malignant pathology and 6.7 % of patients with benign lesions had died. Conclusion: Endoluminal treatment of tracheobronchial stenosis with metallic stents is a therapeutic alternative in patients who are poor candidates for surgery. In unresectable malignant lesions, the benefit of metallic stenting is unquestionable. In benign lesions, the results are satisfactory, but sometimes other interventions are required to treat complications. New stent technology may improve these results.« less

Biodegradable Metals for Cardiovascular Stent Application: Interests and New Opportunities

PubMed Central

Moravej, Maryam; Mantovani, Diego

2011-01-01

During the last decade, biodegradable metallic stents have been developed and investigated as alternatives for the currently-used permanent cardiovascular stents. Degradable metallic materials could potentially replace corrosion-resistant metals currently used for stent application as it has been shown that the role of stenting is temporary and limited to a period of 6–12 months after implantation during which arterial remodeling and healing occur. Although corrosion is generally considered as a failure in metallurgy, the corrodibility of certain metals can be an advantage for their application as degradable implants. The candidate materials for such application should have mechanical properties ideally close to those of 316L stainless steel which is the gold standard material for stent application in order to provide mechanical support to diseased arteries. Non-toxicity of the metal itself and its degradation products is another requirement as the material is absorbed by blood and cells. Based on the mentioned requirements, iron-based and magnesium-based alloys have been the investigated candidates for biodegradable stents. This article reviews the recent developments in the design and evaluation of metallic materials for biodegradable stents. It also introduces the new metallurgical processes which could be applied for the production of metallic biodegradable stents and their effect on the properties of the produced metals. PMID:21845076

Acute Duodenal Obstruction After Percutaneous Placement of Metallic Biliary Stents: Peroral Treatment with Enteral Stents

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lopera, Jorge E.; Alvarez, Oscar A.; Perdigao, Joseph

2003-09-15

Three patients with malignant biliary obstruction were treated with placement of metallic biliary stents. Two patients had known partial duodenal stenosis but had no symptoms of gastrointestinal obstruction. The patients developed symptomatic duodenal obstruction early after biliary metallic stent placement. The symptomatic duodenal obstructions were successfully treated with peroral placement of duodenal stents, which obviated the need for surgical intervention.

Role of metallic stents in benign esophageal stricture

NASA Astrophysics Data System (ADS)

Shim, Chan Sup

2012-10-01

Simple esophageal strictures, which are focal, straight, and large in diameter, usually require 1 - 3 dilation sessions to relieve symptoms. However, complex strictures, which are long, tortuous, or associated with a severely compromised luminal diameter, are usually more difficult to treat with conventional bougie or balloon dilation techniques, and often have high recurrence rates. Although the permanent placement of self-expandable metal stents (SEMS) has been used to manage refractory benign esophageal strictures, this procedure is associated with additional problems, such as stricture from tissue hyperplasia, stent migration, and fistula formation. Thus, several new types of stents have been developed, including temporary SEMS, self-expandable plastic stents (SEPS), and biodegradable stents. The use of these new products has produced varied results. Temporary SEMS that have been used to relieve benign esophageal conditions have caused granulation tissue at both ends of the stent because of contact between the mucosa and the exposed metal components of the stent, thus hindering stent removal. We examined the tissue response to two new types of SEMS, a flange-type and a straighttype, each coated with a silicone membrane on the outside of the metal mesh. These two SEMS were evaluated individually and compared with a conventional control stent in animal experiments. Although the newly designed stents resulted in reduced tissue hyperplasia, and were thus more easily separated from the esophageal tissue, some degree of tissue hyperplasia did occur. We suggest that newly designed DES (drug-eluting stents) may provide an alternative tool to manage refractory benign esophageal stricture.

Silicone Y-Stent Placement on the Secondary Left Carina.

PubMed

Oki, Masahide; Saka, Hideo

2015-01-01

The silicone Y-stent has mainly been used for the treatment of lesions around the main carina, and only a few case reports have been published on the technique for the lesions around the secondary left carina (LC2). We investigated the feasibility, efficacy and safety of a stenting technique using a silicone Y-stent for patients with airway stenosis around LC2. Patients who underwent airway stent placement between December 2010 and September 2014 in a single center were retrospectively reviewed. Under general anesthesia, using rigid and flexible bronchoscopes, the airway lumen was re-established followed by Y-stent placement on LC2. We performed 274 airway stenting procedures for 253 patients during the study period. Twelve of them (7 with lung cancer, 3 with esophageal cancer/carcinosarcoma, 1 with thyroid cancer and 1 with renal cancer) underwent a Y-stent placement on LC2. Respiratory symptoms were relieved in all patients. Six of 7 patients with supplemental oxygen, including the mechanically ventilated patient before stent placement, could be discharged without supplemental oxygen. The chest radiograph after the procedure showed increased lung volume in all 7 patients with partial or complete atelectasis. Median survival after stenting was 197 days at the time of data collection. Retention of secretions occurred in 1 and hemoptysis in another patient. Silicone Y-stent placement on LC2 is technically feasible, effective and acceptably safe. © 2015 S. Karger AG, Basel.

Expandable metal stents for endoscopic bilateral stent-within-stent placement for malignant hilar biliary obstruction.

PubMed

Chahal, Prabhleen; Baron, Todd H

2010-01-01

Placement of biliary stents is effective for palliation of unresectable hilar malignant biliary obstruction. However, when bilateral self-expandable metal stents (SEMSs) are used, placement can be technically challenging. In many studies, side-by-side placement is performed, although it is unclear whether this is the most anatomical and functional approach. We sought to assess the technical feasibility and effectiveness of deploying bilateral SEMSs with a stent-within-stent approach using commercially available stents with a large cell width. Retrospective study. Tertiary care medical center. Patients with malignant biliary hilar obstruction referred for endoscopic palliation of obstructive jaundice. Technical success, ie, successful bilateral SEMS placement across the stricture; functional success, ie, decrease in pretreatment bilirubin level; early and late complications; and stent patency. Bilateral biliary drainage was attempted and successfully established in 21 patients with malignant hilar obstruction (15 men, 6 women; mean age 63.7 [standard deviation 13.9] years), resulting in clinical improvement of obstructive symptoms. Median follow-up was 6.14 months (interquartile range 3.5-9.5 months). There were 1 (5%) early and 7 (33%) late stent occlusions that required endoscopic reintervention. The 30-day mortality rate was 10% (2 deaths). Retrospective study of a series of cases treated at a tertiary care center by expert endoscopists. This simple technique was performed by using an open-cell expandable metal stent is technically feasible and easy and allows bilateral placement of SEMSs in patients with unresectable hilar malignancy. 2010 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

Metallic ureteral stents in malignant ureteral obstruction: clinical factors predicting stent failure.

PubMed

Chow, Po-Ming; Hsu, Jui-Shan; Huang, Chao-Yuan; Wang, Shuo-Meng; Lee, Yuan-Ju; Huang, Kuo-How; Yu, Hong-Jheng; Pu, Yeong-Shiau; Liang, Po-Chin

2014-06-01

To provide clinical outcomes of the Resonance metallic ureteral stent in patients with malignant ureteral obstruction, as well as clinical factors predicting stent failure. Cancer patients who have received Resonance stents from July 2009 to March 2012 for ureteral obstruction were included for chart review. Stent failure was detected by clinical symptoms, image studies, and renal function tests. Survival analysis for stent duration was used to estimate patency rate and factors predicting stent failure. A total of 117 stents were inserted successfully into 94 ureteral units in 79 patients. There were no major complications. These stents underwent survival analysis and proportional hazard regression. The median duration for the stents was 5.77 months. In multivariate analysis, age (P=0.043), preoperative serum creatinine level (P=0.0174), and cancer type (P=0.0494) were significant factors associated with stent failure. Cancer treatment before and after stent insertion had no effect on stent duration. Resonance stents are effective and safe in relieving malignant ureteral obstructions. Old age and high serum creatinine level are predictors for stent failure. Stents in patients with lower gastrointestinal cancers have longer functional duration.

Retreatment of recanalized aneurysms after Y-stent-assisted coil embolization with double enterprise stents: case report and systematic review of the literature.

PubMed

Kono, Kenichi; Shintani, Aki; Terada, Tomoaki

2014-01-01

It is necessary to consider possibility of recanalization and retreatment after coil embolization for cerebral aneurysms. There is concern that retreatment for recanalized aneurysms after Y-stent-assisted coil embolization may be difficult because of double stents, especially in Y-stents with double closed-cell stents owing to narrowed structures. However, no detailed reports of retreatment after Y-stent have been reported. Between July 2010 and June 2013, we treated four aneurysms with Y-stent-assisted coil embolization using Enterprise closed-cell stents. Recanalization occurred in one case (25%), and retreatment was performed. We easily navigated a microcatheter into the target portions of the aneurysm through the Y-stent and occluded the aneurysm with coils. Additionally, by systematically searching in PubMed, we found 105 cases of Y-stent-assisted coil embolization using Enterprise stents or Neuroform stents with more than 6 months of follow-up. Among them, retreatment was performed in 10 cases (9.5%). There were no significant differences in retreatment rates among different stent combinations (P=0.91; Fisher's exact test). In conclusion, navigation of a microcatheter into the aneurysm through the Y-stent with double Enterprise stents was feasible, and retreatment rates after Y-stent-assisted coiling may not depend on stent combinations.

Successful silicon stent for life-threatening tracheal wall laceration.

PubMed

Yamamoto, Shinichi; Endo, Shunsuke; Endo, Tetsuya; Mitsuda, Sayaka

2013-01-01

We report an 86-year-old woman with a large tracheal laceration caused by tracheal intubation at cardiopulmonary arrest who underwent a successful stent procedure. Tracheal laceration developed in the membranous portion longitudinally 6 cm in length to 2 cm above the carina. Following 9 days' tracheal intubation, a Y-shaped silicon stent was inserted over the lacerated trachea. Four months after the stenting procedure, we removed the Y-shaped silicon stent from the healed membranous wall. The patient returned to daily life without requiring thoracotomy.

Predictors of stent dysfunction after self-expandable metal stent placement for malignant gastric outlet obstruction: tumor ingrowth in uncovered stents and migration of covered stents.

PubMed

Hori, Yasuki; Naitoh, Itaru; Hayashi, Kazuki; Ban, Tesshin; Natsume, Makoto; Okumura, Fumihiro; Nakazawa, Takahiro; Takada, Hiroki; Hirano, Atsuyuki; Jinno, Naruomi; Togawa, Shozo; Ando, Tomoaki; Kataoka, Hiromi; Joh, Takashi

2017-10-01

Endoscopic metallic stenting is widely accepted as a palliation therapy for malignant gastric outlet obstruction (GOO). However, the predictors of stent dysfunction have not been clarified. We aimed to evaluate the predictors, especially tumor ingrowth in uncovered self-expandable metallic stents (U-SEMS) and migration of covered self-expandable metallic stents (C-SEMS), which are the main causes related to the stent characteristics. In this multicenter retrospective study, we compared patients with U-SEMS and C-SEMS in terms of clinical outcomes, and predictors of stent dysfunction. In total, 252 patients (126 with U-SEMS and 126 with C-SEMS) were enrolled. There were no significant differences in technical success, clinical success, GOO score, or time to stent dysfunction. Tumor ingrowth was significantly more frequent in U-SEMS (U-SEMS, 11.90% vs. C-SEMS, 0.79%; p = 0.002), and stent migration was significantly more frequent for C-SEMS (C-SEMS, 8.73% vs. U-SEMS, 0.79%; p = 0.005). Karnofsky performance status (p = 0.04), no presence of ascites (p = 0.02), and insufficient (<30%) stent expansion (p = 0.003) were significantly associated with tumor ingrowth in U-SEMS. Meanwhile, a shorter stent length (p = 0.05) and chemotherapy (p = 0.03) were predictors of C-SEMS migration. Both U-SEMS and C-SEMS are effective with comparable patencies. Tumor ingrowth and stent migration are the main causes of stent dysfunction for U-SEMS and C-SEMS, respectively. With regard to stent dysfunction, U-SEMS might be a good option for patients receiving chemotherapy, while C-SEMS with longer stents for patients in good condition. (Clinical trial registration number: UMIN000024059).

Endoscopic management of malignant biliary obstruction by means of covered metallic stents: primary stent placement vs. re-intervention.

PubMed

Kida, M; Miyazawa, S; Iwai, T; Ikeda, H; Takezawa, M; Kikuchi, H; Watanabe, M; Imaizumi, H; Koizumi, W

2011-12-01

Recent progress in chemotherapy has prolonged the survival of patients with malignant biliary strictures, leading to increased rates of stent occlusion. Occlusion of covered metallic stents now occurs in about half of all patients with malignant biliary strictures. The removal of metallic stents followed by placement of a second stent has been attempted, but outcomes remain controversial. The aim of the current study was to evaluate the effectiveness and safety of the primary placement and secondary placement (re-intervention) of covered metallic stents and to assess the feasibility and safety of stent removal. The study included 186 patients with unresectable malignant biliary strictures who underwent primary stent placement between October 2001 and March 2010.  Covered biliary self-expandable metal stents (SEMSs) were removed in 39 of these patients, and 36 underwent re-intervention. The patency times, occlusion rates of the first stent and re-intervention, success rates of stent removal, and complications were investigated. Covered SEMSs were placed in 186 patients. The median patency time of the first stent was 352 days. Stent occlusion occurred in 48.9 % of the patients and was mainly caused by debris or food residue (37 %), dislocation (19 %), and migration with hyperplasia (19 %). Stent removal was attempted in 50 patients and was successful without complication in 39 (78 %). Most of the patients in whom stent removal was unsuccessful had migration with hyperplasia. The median patency time of the second stent was 263 days. The stent patency time did not significantly differ between the first and the second stent. Covered SEMSs could be safely removed at the time of stent occlusion. Patency rates were similar for initial stent placement and re-intervention. © Georg Thieme Verlag KG Stuttgart · New York.

Metallic Full-Length Ureteral Stents: Does Urinary Tract Infection Cause Obstruction?

PubMed Central

Brown, James A.; Powell, Christopher L.; Carlson, Kristopher R.

2010-01-01

Metallic ureteral stents promise to offer superior upper urinary tract drainage with extended exchange intervals and freedom from extrinsic compression in patients with advanced malignancy or other significant obstructing retroperitoneal or pelvic processes. Existing literature indicates a variable experience with these relatively new devices, with some investigators reporting excellent results and long problem-free intervals, and others reporting less enthusiastic outcomes. We report a retrospective review of a series of five sequential patients undergoing placement of Resonance® (Cook Medical, Bloomington, IN) metallic ureteral stents for extrinsic ureteral compression refractory to placement of traditional (polymer) ureteral stents. Of five patients reviewed, three (60%) required additional operative intervention for stent migration or malposition. Four patients (80%) died of their primary malignancy <12 months after metallic stent placement. Four (80%) of five patients had obstruction of their stents demonstrated with nuclear renography and/or other imaging, and three (60%) required removal and alternative means of urinary tract drainage within 4 months of placement due to obstruction, intractable pain, or migration. Four patients (80%) had urinary tract infections (UTIs) within 4 months of stent placement. No obstruction was seen due to extrinsic ureteral compression after stent placement. Metallic ureteral stents may have utility for patients with pathological processes causing extrinsic ureteral compression refractory to the use of traditional polymer ureteral stents. However, metallic ureteral stents are not immune to obstruction, migration, and associated discomfort. Stent obstruction appears to be increased in patients with postoperative UTI. PMID:20730376

Metallic full-length ureteral stents: does urinary tract infection cause obstruction?

PubMed

Brown, James A; Powell, Christopher L; Carlson, Kristopher R

2010-08-17

Metallic ureteral stents promise to offer superior upper urinary tract drainage with extended exchange intervals and freedom from extrinsic compression in patients with advanced malignancy or other significant obstructing retroperitoneal or pelvic processes. Existing literature indicates a variable experience with these relatively new devices, with some investigators reporting excellent results and long problem-free intervals, and others reporting less enthusiastic outcomes. We report a retrospective review of a series of five sequential patients undergoing placement of Resonance (Cook Medical, Bloomington, IN) metallic ureteral stents for extrinsic ureteral compression refractory to placement of traditional (polymer) ureteral stents. Of five patients reviewed, three (60%) required additional operative intervention for stent migration or malposition. Four patients (80%) died of their primary malignancy <12 months after metallic stent placement. Four (80%) of five patients had obstruction of their stents demonstrated with nuclear renography and/or other imaging, and three (60%) required removal and alternative means of urinary tract drainage within 4 months of placement due to obstruction, intractable pain, or migration. Four patients (80%) had urinary tract infections (UTIs) within 4 months of stent placement. No obstruction was seen due to extrinsic ureteral compression after stent placement. Metallic ureteral stents may have utility for patients with pathological processes causing extrinsic ureteral compression refractory to the use of traditional polymer ureteral stents. However, metallic ureteral stents are not immune to obstruction, migration, and associated discomfort. Stent obstruction appears to be increased in patients with postoperative UTI.

Role of laser photoablative therapy and expandable metal stents in colorectal carcinoma

NASA Astrophysics Data System (ADS)

Chennupati, Raja S.; Trowers, Eugene A.

2000-05-01

Metallic stents are effective in relieving colorectal obstruction in more than 80% of cases. Self expanding metallic stents allow for decompression of the proximal colon and preoperative bowel cleansing. Hence, emergent surgery for large bowel obstruction with its associated high morbidity and mortality might be avoided. Endoscopic laser photoablation and stent placement may successfully palliate inoperable colorectal cancer patients by maintaining luminal patency and avoiding the need for a colostomy. Major complications associated with metallic stents include pressure necrosis, perforation, bleeding and migration. The effectiveness of expandable metallic stents in obstructive colorectal carcinoma is critically reviewed. The authors present a concise review of the effectiveness of endoscopic laser photoablation and expandable metal stent placement.

Comparison of outcomes among secondary covered metallic, uncovered metallic, and plastic biliary stents in treating occluded primary metallic stents in malignant distal biliary obstruction.

PubMed

Cho, Jae Hee; Jeon, Tae Joo; Park, Jeong Youp; Kim, Hee Man; Kim, Yoon Jae; Park, Seung Woo; Chung, Jae Bock; Song, Si Young; Bang, Seungmin

2011-02-01

The self-expandable metallic stent (SEMS) has been widely used for unresectable malignant biliary obstruction but eventually becomes occluded by tumor ingrowth/overgrowth and sludge. Therefore, we aimed to determine the therapeutic effectiveness of secondary stents and to find differences according to various combinations of the first and second stents for the management of occluded SEMSs in patients with malignant distal biliary obstruction. Between 1999 and November 2008, 77 patients with malignant biliary obstruction underwent secondary biliary stent placement as "stent-in-stent" at three university hospitals in Korea (40 covered, 26 uncovered, and 11 plastic stents). The membrane of the covered SEMS was regarded as the barrier against tumor ingrowth. We categorized the patients into three groups based on whether the covered SEMS was either the first or the second stent: membrane-SEMS (18 covered-covered; 9 covered-uncovered; 22 uncovered-covered SEMS), bare-SEMS (17 uncovered-uncovered SEMS), and plastic stent (3 covered-plastic; 8 uncovered-plastic). The median patency of second stents was 138, 109, and 88 days (covered, uncovered, and plastic stents). The second covered SEMSs had a significantly longer patency than plastic stents (p=0.047). In a multivariate analysis including membrane-SEMS, bare-SEMS, and plastic stent groups, the bare-SEMS had a worse cumulative stent patency (HR=2.04, CI=1.08-3.86) and survival time (HR=2.37, CI=1.25-4.49) than the membrane-SEMS. Patients with ampulla of Vater cancer had better stent patency (HR=0.27, CI=0.08-0.98) and survival (HR=0.17, CI=0.04-0.77) than those with other pancreatobiliary malignancies. In addition, antitumor treatment prolonged survival time (HR=0.50, CI=0.26-0.99). The placement of additional biliary stents using the "stent-in-stent" method is an effective treatment for an occluded metallic primary stent. In addition, double biliary SEMS placement using at least one covered SEMS (in the primary and

Tracheal obstruction caused by an expandable metallic stent: a case of successful removal of the stent.

PubMed

Okuyama, Hiroomi; Kubota, Akio; Kawahara, Hisayoshi; Oue, Takaharu; Nose, Satoko; Ihara, Toshiyuki

2005-07-01

We report a case of tracheal obstruction caused by an expandable metallic stent. A 3-month-old girl with severe tracheomalacia had a placement of a Palmaz stent. At 3 years of age, she developed progressive dyspnea. The CT scan showed tracheal obstruction caused by granulation tissue over the stent. At operation, the stent was found to have penetrated the posterior tracheal wall. Under partial cardiopulmonary bypass, the stent was removed along with the membranous wall of the trachea, and the trachea was reconstructed using slide tracheoplasty. Tracheal obstruction is one of the serious complications caused by an expandable metallic stent. Direct open approach to the trachea under cardiopulmonary bypass is thought to be a safe way to manage this problem.

First Experience of Inserting a Metallic Mesh Stent (Uventa Stent) in Malignant Ureteral Obstruction in Iran.

PubMed

Ghaed, Mohammad Ali; Daniali, Maziar; Ebrahimian, Mohammad

2018-05-03

Malignant ureteral obstruction is usually caused by an extrinsic compression including intra-abdominal cancers. One of the treatment modalities decompressing the obstruction is applying stent to open the ureter. Metallic Stent is an effective instrument which we used for the first time in Iran in our patient who had a metastatic colon cancerwith a single kidney and we used a Novel, Double-Layered, Coated, Self-expandable Metallic Mesh Stent (Uventa Stent) to keep the ureter open. After six months of follow up with ureteroscopy, there was no obstruction any more.

Drug-eluting versus bare-metal coronary stents: where are we now?

PubMed

Amoroso, Nicholas S; Bangalore, Sripal

2012-11-01

Drug-eluting stents have dramatically reduced the risk of restenosis, but concerns of an increased risk of stent thrombosis have provided uncertainty about their use. Recent studies have continued to show improved procedural and clinical outcomes with drug-eluting stents both in the setting of acute coronary syndromes and stable coronary artery disease. Newer generation drug-eluting stents (especially everolimus-eluting stents) have been shown to be not only efficacious but also safe with reduced risk of stent thrombosis when compared with bare-metal stents, potentially changing the benchmark for stent safety from bare-metal stents to everolimus-eluting stents. While much progress is being made in the development of bioabsorbable polymer stents, nonpolymer stents and bioabsorbable stent technology, it remains to be seen whether these stents will have superior safety and efficacy outcomes compared with the already much improved rates of revascularization and stent thrombosis seen with newer generation stents (everolimus-eluting stents and resolute zotarolimus-eluting stents).

A prospective randomized study for efficacy of an uncovered double bare metal stent compared to a single bare metal stent in malignant biliary obstruction.

PubMed

Lee, Hyun Jik; Chung, Moon Jae; Park, Jeong Yup; Park, Seung Woo; Nam, Chung Mo; Song, Si Young; Bang, Seungmin

2017-08-01

A biliary self-expandable metal stent (SEMS) is commonly used to relieve malignant biliary obstruction. The aim of this study was to compare the efficacy of a conventional uncovered SEMS with that of a newly developed uncovered double bare metal stent in reducing the risk of stent occlusion caused by tumor ingrowth. We performed a prospective, open-labeled, randomized trial in 71 patients at Severance Hospital, Yonsei University College of Medicine from June 2013 to June 2014. Patients with inoperable malignant biliary obstruction were included and randomized to receive an uncovered single bare metal stent (SBSs; S&G Biotech Inc.), an uncovered single bare metal stent (SBSt; Taewoong Medical), or an uncovered double bare metal stent (DBS; S&G Biotech Inc.). The mean age was 66.6 years (range, 35-83), and 42 (59.2%) were male. The mean duration of stent patency was 212 days (±152) in the DBS group (n = 24) compared with 124 days (±98) in the SBSs group (n = 23; P = 0.022 for noninferiority) and 116 days (±79) in the SBSt group (n = 24; P = 0.010 for noninferiority). There were no differences in the incidences of early and delayed complications or migration. The newly developed DBS is noninferior to the conventional uncovered SEMSs on duration of stent patency and tumor ingrowth occurred less frequently in the DBS group. This might decrease the need for reintervention and offer a better quality of life. The trial is registered with Clinicaltrials.gov no: NCT01869894.

Obstruction after Self-expanding Metallic Stents in Tuberculous Bronchial Stenosis

PubMed Central

Kim, Won; Lee, Youg Chul; Rhee, Yang Keun

1995-01-01

Expandable metallic stents seemed to be a good method in tuberculous bronchial stenosis that does not respond to medical therapy. But there was no long-term follow-up study after stents insertion in tuberculous bronchial stenosis. We report a case of obstruction after successful Gianturco metallic stents insertion due to tuberculous bronchial stenosis. PMID:7542914

Covered duodenal self-expandable metal stents prolong biliary stent patency in double stenting: The largest series of bilioduodenal obstruction.

PubMed

Hori, Yasuki; Naitoh, Itaru; Hayashi, Kazuki; Kondo, Hiromu; Yoshida, Michihiro; Shimizu, Shuya; Hirano, Atsuyuki; Okumura, Fumihiro; Ando, Tomoaki; Jinno, Naruomi; Takada, Hiroki; Togawa, Shozo; Joh, Takashi

2018-03-01

Endoscopic biliary and duodenal stenting (DS; double stenting) is widely accepted as a palliation therapy for malignant bilioduodenal obstruction. The aim of the current study was to investigate the patency and adverse events of duodenal and biliary stents in patients with DS. Patients who underwent DS from April 2004 to March 2017 were analyzed retrospectively with regard to clinical outcomes and predictive factors of recurrent biliary and duodenal obstruction (recurrent biliary obstruction [RBO] and recurrent duodenal obstruction [RDO]). A total of 109 consecutive patients was enrolled. Technical success of DS was achieved in 108 patients (99.1%). Symptoms due to biliary and duodenal obstruction were improved in 89 patients (81.7%). RBO occurred in 25 patients (22.9%) and RDO in 13 (11.9%). The median times to RBO and RDO from DS were 87 and 76 days, respectively. Placement of a duodenal uncovered self-expandable metal stent (U-SEMS) was significantly associated with RBO in the multivariable analysis (P = 0.007). Time to RBO was significantly longer in the duodenal covered self-expandable metal stent group than in the U-SEMS group (P = 0.003). No predictive factors of RDO were detected, and duodenal stent type was not associated with the time to RDO (P = 0.724). Double stenting was safe and effective for malignant bilioduodenal obstruction. Duodenal U-SEMS is a risk factor for RBO. The covered self-expandable metal stent is the preferred type of duodenal SEMS in patients with DS (Clinical trial registration number: UMIN000027606). © 2017 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.

Management of occluded metal stents in malignant biliary obstruction: similar outcomes with second metal stents compared to plastic stents

PubMed Central

Shah, Tilak; Desai, Svetang; Haque, Mahfuzul; Dakik, Hassan; Fisher, Deborah

2013-01-01

Background Covered or uncovered self expandable metallic stents (SEMS) placed in patients with malignant biliary obstruction can occlude in 19–40%, but optimal management is unclear. Aim We sought to summarize current evidence regarding management of occluded SEMS in patients with malignant biliary obstruction. Methods Two investigators independently searched Pubmed, Embase, and Web of Science using pre-defined search criteria, and reviewed bibliographies of included studies. Data were independently abstracted by two investigators, and analyzed using RevMan. We compared strategies of second SEMS versus plastic stents with respect to the following outcomes: rate of second stent re-occlusion, duration of second stent patency, and survival. Results Ten retrospective studies met inclusion criteria for the systematic review. Management options described were placement of an uncovered SEMS (n=125), covered SEMS (n=106), plastic stent (n=135), percutaneous biliary drain (n=7), mechanical cleaning (n=18), or microwave coagulation (n=7). Relative risk of re-occlusion was not significantly different in patients with second SEMS compared to plastic stents (RR 1.24, 95% CI 0.92, 1.67, I2= 0, p 0.16). Duration of second stent patency was not significantly different between patients who received second SEMS versus plastic stents (weighted mean difference 0.46, 95% CI −0.30, 1.23, I2=83%). Survival was not significantly different among patients who received plastic stents versus SEMS (weighted mean difference −1.13, 95% CI −2.33, 0.07, I2 86%, p 0.07). Conclusions Among patients with malignant biliary obstruction and occluded SEMS, available evidence suggests a strategy of placing a plastic stent may be as effective as second SEMS. Limitations of these findings were that all studies were retrospective and heterogeneity between studies was detected for two of the outcomes. PMID:22732833

Biliary metal stents for proximal esophageal or hypopharyngeal strictures.

PubMed

Bechtler, Matthias; Wagner, Florian; Fuchs, Erik-Sebastian; Jakobs, Ralf

2015-11-01

Endoscopic dilation is the standard of care for stenoses of the cervical esophagus, but refractory strictures require some form of stenting. Most endoscopists avoid the placement of metal stents near the upper esophageal sphincter as they can cause major problems like severe cervical pain and globus sensation. We report our results with the use of biliary SEMS in the upper esophagus, which have a smaller diameter than regular esophageal stents and therefore exert less expansive force. We retrospectively reviewed all patients in our center between July 2011 and June 2014 who received a biliary metal stent because of a refractory stricture in the cervical esophagus. We implanted biliary SEMS (Wallflex, Boston Scientific) with a diameter of 1 cm and length of 6-8 cm. Technical and clinical success, adverse events and duration of stenting were evaluated. Ten patients were treated with biliary SEMS in the upper esophagus. Strictures were located between 10 and 19 cm from incisor teeth. Stent placement was successful in all (10/10) patients. One stent had to be extracted because of pain and globus sensation. Apart from that stent tolerability was good. All remaining patients (9/9) reported improvement of dysphagia with a decrease in mean dysphagia score from 3.2 to 1.78. Mean duration of stenting was 68 days. Because of a high clinical success rate and good tolerability, biliary metal stents are a reasonable alternative for difficult strictures in the cervical esophagus, especially in the palliative setting.

Sutureless microvascular anastomosis assisted by an expandable shape-memory alloy stent

PubMed Central

Saegusa, Noriko; Sarukawa, Shunji; Ohta, Kunihiro; Takamatsu, Kensuke; Watanabe, Mitsuhiro; Sugino, Takashi; Nakagawa, Masahiro; Akiyama, Yasuto; Kusuhara, Masatoshi; Kishi, Kazuo; Inoue, Keita

2017-01-01

Vascular anastomosis is the highlight of cardiovascular, transplant, and reconstructive surgery, which has long been performed by hand using a needle and suture. However, anastomotic thrombosis occurs in approximately 0.5–10% of cases, which can cause serious complications. To improve the surgical outcomes, attempts to develop devices for vascular anastomosis have been made, but they have had limitations in handling, cost, patency rate, and strength at the anastomotic site. Recently, indwelling metal stents have been greatly improved with precise laser metalwork through programming technology. In the present study, we designed a bare metal stent, Microstent, that was constructed by laser machining of a shape-memory alloy, NiTi. An end-to-end microvascular anastomosis was performed in SD rats by placing the Microstent at the anastomotic site and gluing the junction. The operation time for the anastomosis was significantly shortened using Microstent. Thrombus formation, patency rate, and blood vessel strength in the Microstent anastomosis were superior or comparable to hand-sewn anastomosis. The results demonstrated the safety and effectiveness, as well as the operability, of the new method, suggesting its great benefit for surgeons by simplifying the technique for microvascular anastomosis. PMID:28742116

The effect of stent coating on stent deliverability: direct randomised comparison of drug eluting and bare metal stents using the same stent platform.

PubMed

Siminiak, Tomasz; Link, Rafał; Wołoszyn, Maciej; Kałmucki, Piotr; Baszko, Artur

2012-01-01

There is certain experimental and clinical evidence indicating that the covering of bare metal stents (BMS) with drug eluting polymers to produce drug eluting stents (DES) results in increased stent stiffness and modifies the mechanical properties of the stent platform. In addition, it has been speculated that the mechanical performance of DES, compared to BMS, may be related to the type of polymer used to cover stents. We aimed at evaluating the deliverability of DES with a lactate based biodegradable polymer and BMS in patients with stable coronary artery disease in a prospective randomised study. One hundred eleven consecutive patients (age: 36-77, mean 58.8 years) scheduled for routine angioplasty due to stable coronary disease were randomised to receive BMS (Chopin II(TM), Balton, Poland) or paclitaxel eluting stent (Chopin Luc(TM), Balton, Poland) using the same metal platform. Only patients scheduled for angioplasty using the direct implantation technique of a single stent were randomised. The exclusion criteria included patients 〉 80 years, multivessel disease and reference diameter of the target vessel 〉 3.5 mm. In the BMS group (n = 55; 35 males and 20 females), the mean diameter of implanted stents was 3.09 ± 0.40 and the mean length was 11.37 ± 2.80, whereas in the DES group (n = 56; 34 males and 22 females) the mean stent sizes were 3.02 ± 0.34 and 17.90 ± 7.38 mm, respectively (p 〉 0.05 for length). The groups did not significantly differ regarding the frequency of stent implantation to particular coronary vessels. The direct stenting technique was attempted and failed, leading to the stents' implantation after predilatation in five patients in the BMS group and six patients in the DES group. Failure of stent implantation and subsequent implantation of another stent type was observed in no BMS patients and in one DES patient (NS). Although stent covering with lactate based drug eluting polymer may increase its stiffness, it does not affect

Food impaction after expandable metal stent placement: experience in 1,360 patients with esophageal and upper gastrointestinal tract obstruction.

PubMed

Song, Min; Song, Ho-Young; Kim, Jin Hyoung; Park, Jung-Hoon; Jung, Hwoon-Yong; Kim, Jong-Hoon; Kim, Sung-Bae

2011-09-01

To retrospectively evaluate the incidence, predictive factors, and interventional management of food impaction after expandable metallic stent placement in patients with obstruction of the esophagus or upper gastrointestinal tract caused by benign or malignant disease. Between March 1993 and March 2010, 1,360 patients (1,029 men, 331 women; age range, 21-89 y; mean age, 61 y) underwent fluoroscopically guided stent placement for dysphagia caused by esophageal or gastrointestinal tract strictures. Five types of covered expandable metal stents were used, including four types of esophageal stents (types A-D) and one type of gastroduodenal stent (type E), with types A, B, C, D, and E stents used in 180, 60, 90, 432, and 598 patients, respectively. Multivariate analysis was performed to evaluate factors predictive of food impaction. Food impaction occurred in 41 of 1,360 patients (3.0%). The food impaction rates for types A, B, C, D, and E stents were 0.6%, 1.7%, 1.1%, 3.2%, and 4.0%, respectively. Multivariate analysis showed that stent length was an independent predictor of food impaction (odds ratio, 0.839; P = .012). Of the 41 patients with food impaction, 23 underwent endoscopic management, 12 underwent fluoroscopically guided management, and six did not require management because impacted food spontaneously passed through the stent. The overall food impaction rate was 3.0%, with multiple logistic regression analysis showing that shorter stent length was the only significant predictor of food impaction. Food impaction can be managed by endoscopic or fluoroscopically guided removal or placement of a second stent. Copyright © 2011 SIR. Published by Elsevier Inc. All rights reserved.

Y-configuration double-stent-assisted coiling using two closed-cell stents for wide-neck basilar tip aneurysms.

PubMed

Jeon, Pyoung; Kim, Byung Moon; Kim, Dong Joon; Kim, Dong I K; Park, Keun Young

2014-09-01

This study aimed to evaluate clinical and angiographic outcomes of Y-configuration double-stent-assisted (Y-stent) coiling using two closed-cell stents for wide-necked basilar tip aneurysm (BTA). A total of 25 patients underwent Y-stent coiling using two closed-cell stents as a first-time treatment in 18 (3 ruptured) BTAs, retreatment in 2 BTAs and as a third treatment in 5 wide-necked BTAs. Clinical and angiographic outcomes were evaluated retrospectively. Treatment-related complications were three (12.0 %) thromboembolic infarctions due to two acute in-stent thromboses and one embolism. Twenty-two (88 %) patients had favorable outcomes (modified Rankin scale score [mRS], 0-2) during the follow-up period (mean, 30 months; range, 6-54 months). Two patients died: one from initial subarachnoid hemorrhage and the other from intracerebral hemorrhage due to underlying Moyamoya disease. Post-treatment angiograms showed complete occlusion in nine aneurysms, residual neck in 11 aneurysms and residual sac in five aneurysms. Follow-up angiograms were available at least once between 5 to 34 months (mean, 16 months) in 21 patients. Nineteen patients showed improved or stable states (complete occlusion, n = 17; residual neck, n = 2). Major recurrences occurred in two BTAs (9.5 %). Those two major recurrent aneurysms had been large-sized aneurysms at the initial coiling procedure. Both showed not only coil compaction but also progressive growth to giant-sized aneurysms and intra-aneurysmal thrombus formation at the Y-stent coiling as a third-time treatment. Y-stent coiling using two closed-cell stents is a safe and durable treatment option for wide-necked BTA, but may have limited efficacy for large/giant sized and thrombosed aneurysms.

Stent implantation into the tracheo-bronchial system in rabbits: histopathologic sequelae in bare metal vs. drug-eluting stents.

PubMed

Sigler, Matthias; Klötzer, Julia; Quentin, Thomas; Paul, Thomas; Möller, Oliver

2015-12-01

Stent implantation into the tracheo-bronchial system may be life-saving in selected pediatric patients with otherwise intractable stenosis of the upper airways. Following implantation, significant tissue proliferation may occur, requiring re-interventions. We sought to evaluate the effect of immunosuppressive coating of the stents on the extent of tissue proliferation in an animal model. Bare metal and sirolimus-coated stents (Bx Sonic and Cypher Select, Johnson & Johnson, Cordis) were implanted into non-stenotic lower airways of New Zealand white rabbits (weight 3.1 to 4.8 kg). Three stents with sirolimus coating and six bare metal stents could be analyzed by means of histology and immunohistochemistry 12 months after implantation. On a macroscopic evaluation, all stents were partially covered with a considerable amount of whitish tissue. Histologically, these proliferations contained fiber-rich connective tissue and some fibromuscular cells without significant differences between both stent types. The superficial tissue layer was formed by typical respiratory epithelium and polygonal cells. Abundant lymphocyte infiltrations and moderate granulocyte infiltrations were found in both groups correspondingly, whereas foreign-body reaction was more pronounced around sirolimus-eluting stents. After stent implantation in the tracheo-bronchial system of rabbits, we found tissue reactions comparable to those seen after stent implantation into the vascular system. There was no difference between coated and uncoated stents with regard to quality and quantity of tissue proliferation. We found, however, a significantly different inflammatory reaction with a more pronounced foreign-body reaction in sirolimus-coated stents. In our small series, drug-eluting stents did not exhibit any benefit over bare metal stents in an experimental setting.

Self-Expandable Metallic Stent Placement in Malignant Gastric Outlet Obstruction: A Comparison Between 2 Brands of Stents.

PubMed

Ye, Bing-Wei; Lee, Kuei-Chuan; Hsieh, Yun-Cheng; Li, Chung-Pin; Chao, Yee; Hou, Ming-Chih; Lin, Han-Chieh

2015-07-01

Malignant gastric outlet obstruction is a late complication of intraabdominal malignancy. Self-expandable metallic stent placement has been a safe palliative treatment to relieve obstructive symptoms. We aimed to assess the efficacy and safety of metallic stents in our patients and analyzed the clinical outcome of different brands. Seventy-one patients with inoperable gastric outlet obstruction receiving WallFlex enteral stents (WallFlex group) or Bonastents (Bonastent group) since April 2010 were analyzed retrospectively. The overall technical and clinical success rates of stent placement were 100% and 93%, respectively. The baseline characteristics and clinical outcomes including procedure-related complications, restenosis, and reintervention rates were comparable between the 2 groups. However, the Bonastent group had a higher rate of stent fracture than the WallFlex group (13.3% vs 0%, P = 0.03). The mean duration of overall stent patency was 132.7 days. The mean duration of survival was 181.9 days. Resumption of regular diet or low residual diet at day 7 after stent insertion predicted stent patency (hazard ratio [HR]: 0.28, P = 0.01). Cancer with gastric origin (HR: 0.25, P = 0.045) and poststent chemotherapy (HR: 0.38, P = 0.006) predicted lower mortality; however, peritoneal carcinomatosis (HR: 3.09, P = 0.04) correlated with higher mortality. Metallic stent placement is a safe and effective method for relieving gastric outlet obstruction. Except higher rate of stent fracture in the Bonastent group, there is no significant difference in clinical outcomes between the Bonastent group and the WallFlex group.

Crossing Y-stent technique with dual open-cell stents for coiling of wide-necked bifurcation aneurysms.

PubMed

Ko, Jun Kyeung; Han, In Ho; Cho, Won Ho; Choi, Byung Kwan; Cha, Seung Heon; Choi, Chang Hwa; Lee, Sang Weon; Lee, Tae Hong

2015-05-01

Double stenting in a Y-configuration is a promising therapeutic option for wide-necked cerebral aneurysms not amenable to reconstruction with a single stent. We retrospectively evaluated the efficacy and safety of the crossing Y-stent technique for coiling of wide-necked bifurcation aneurysms. By collecting clinical and radiological data we evaluated from January 2007 through December 2013, 20 wide-necked bifurcation aneurysms. Twelve unruptured and eight ruptured aneurysms in 20 patients were treated with crossing Y-stent-assisted coiling. Aneurysm size and neck size ranged from 3.2 to 28.2mm (mean 7.5mm) and from 1.9 to 9.1mm (mean 4.5mm). A Y-configuration was established successfully in all 20 patients. All aneurysms were treated with a pair of Neuroform stents. The immediate angiographic results were total occlusion in 17 aneurysms, residual neck in two, and residual sac in one. Peri-operative morbidity was only 5%. Fifteen of 18 surviving patients underwent follow-up conventional angiography (mean, 10.9 months). The result showed stable occlusion in all 15 aneurysms and asymptomatic in-stent occlusion in one branch artery. At the end of the observation period (mean, 33.5 months), all 12 patients without subarachnoid hemorrhage had excellent clinical outcomes (mRS 0), except one (mRS 2). Of eight patients with subarachnoid hemorrhage, four remained symptom free (mRS 0), while the other four had were dependent or dead (mRS score, 3-6). In this report on 20 patients, crossing Y-stent technique for coiling of wide-necked bifurcation aneurysms showed a good technical safety and favorable clinical and angiographic outcome. Copyright © 2015. Published by Elsevier B.V.

Treatment of esophagopleural fistulas using covered retrievable expandable metallic stents.

PubMed

Kim, Tae-Hyung; Shin, Ji Hoon; Kim, Kyung Rae; Park, Jung-Hoon; Kim, Jin Hyoung; Song, Ho-Young

2014-04-01

To evaluate the clinical efficacy of placement of covered retrievable expandable metallic stents for esophagopleural fistulas (EPFs). During 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). Technical 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. Placement 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. Copyright © 2014 SIR. Published by Elsevier Inc. All rights reserved.

Bare metal stents, durable polymer drug eluting stents, and biodegradable polymer drug eluting stents for coronary artery disease: mixed treatment comparison meta-analysis

PubMed Central

Toklu, Bora; Amoroso, Nicholas; Fusaro, Mario; Kumar, Sunil; Hannan, Edward L; Faxon, David P; Feit, Frederick

2013-01-01

Objective To compare the efficacy and safety of biodegradable polymer drug eluting stents with those of bare metal stents and durable polymer drug eluting stents. Design Mixed treatment comparison meta-analysis of 258 544 patient years of follow-up from randomized trials. Data sources and study selection PubMed, Embase, and Central were searched for randomized trials comparing any of the Food and Drug Administration approved durable polymer drug eluting stents (sirolimus eluting, paclitaxel eluting, cobalt chromium everolimus eluting, platinum chromium everolimus eluting, zotarolimus eluting-Endeavor, and zotarolimus eluting-Resolute) or biodegradable polymer drug eluting stents, with each other or against bare metal stents. Outcomes Long term efficacy (target vessel revascularization, target lesion revascularization) and safety (death, myocardial infarction, stent thrombosis). Landmark analysis at more than one year was evaluated to assess the potential late benefit of biodegradable polymer drug eluting stents. Results From 126 randomized trials and 258 544 patient years of follow-up, for long term efficacy (target vessel revascularization), biodegradable polymer drug eluting stents were superior to paclitaxel eluting stents (rate ratio 0.66, 95% credibility interval 0.57 to 0.78) and zotarolimus eluting stent-Endeavor (0.69, 0.56 to 0.84) but not to newer generation durable polymer drug eluting stents (for example: 1.03, 0.89 to 1.21 versus cobalt chromium everolimus eluting stents). Similarly, biodegradable polymer drug eluting stents were superior to paclitaxel eluting stents (rate ratio 0.61, 0.37 to 0.89) but inferior to cobalt chromium everolimus eluting stents (2.04, 1.27 to 3.35) for long term safety (definite stent thrombosis). In the landmark analysis after one year, biodegradable polymer drug eluting stents were superior to sirolimus eluting stents for definite stent thrombosis (rate ratio 0.29, 0.10 to 0.82) but were associated with increased

Mechanical Characteristics of Composite Knitted Stents

DOE Office of Scientific and Technical Information (OSTI.GOV)

Tokuda, Takanori, E-mail: tkdtknr@gmail.com; Shomura, Yuzo; Tanigawa, Noboru

2009-09-15

We used metal wires and fibers to fabricate a composite knitted stent and then compare the mechanical characteristics of this stent with those of a pure metallic stent of the same construction in order to develop a stent that offers a comparable degree of expandability as metallic stents but can be used for highly curved lesions that cannot be treated using metallic stents. We fabricated two types of composite knitted stent (N-Z stents), using nitinol wire with a diameter of 0.12 mm and polypara-phenylene-benzobisoxazole (PBO) multifilament fiber (Zyron AS; Toyobo, Osaka, Japan). Stents were knitted into a cylindrical shape usingmore » the same textile pattern as a Strecker stent. Two loop lengths (L) of nitinol wire were used in the N-Z stents: L = 1.84 mm (N-Z stent L = 1.84) and L = 2.08 mm (N-Z stent L = 2.08). For the sake of comparison, we fabricated a metallic stent of nitinol using the same textile pattern (N-N stent L = 1.92). We applied a radial compression force diametrically to each stent and applied a bending force diametrically at the free end of a stent with one end fixed in order to evaluate the relationship between stent elasticity and load values. In addition, we macroscopically evaluated the generation of kinks when the stent was bent 180{sup o}. The radial compressive force when the stent diameter was reduced by 53% was 6.44 N in the case of N-Z stent L = 1.84, 6.14 N in the case of N-Z stent L = 2.08, and 4.96 N in the case of N-N stent L = 1.92 mm. The composite stent had a radial compressive force higher than that of a metallic stent. The restoring force to longitudinal direction at a 90{sup o} bending angle was 0.005 N for N-Z stent L = 1.84, 0.003 N for N-Z stent L = 2.08, and 0.034 N for N-N stent L = 1.92. The restoring force of the composite stent was significantly lower. Finally, the composite stent generated no definitive kinks at a bending angle of 180{sup o}, regardless of loop length. However, the N-N stent clearly produced kinks

Targeting In-Stent-Stenosis with RGD- and CXCL1-Coated Mini-Stents in Mice.

PubMed

Simsekyilmaz, Sakine; Liehn, Elisa A; Weinandy, Stefan; Schreiber, Fabian; Megens, Remco T A; Theelen, Wendy; Smeets, Ralf; Jockenhövel, Stefan; Gries, Thomas; Möller, Martin; Klee, Doris; Weber, Christian; Zernecke, Alma

2016-01-01

Atherosclerotic lesions that critically narrow the artery can necessitate an angioplasty and stent implantation. Long-term therapeutic effects, however, are limited by excessive arterial remodeling. We here employed a miniaturized nitinol-stent coated with star-shaped polyethylenglycole (star-PEG), and evaluated its bio-functionalization with RGD and CXCL1 for improving in-stent stenosis after implantation into carotid arteries of mice. Nitinol foils or stents (bare metal) were coated with star-PEG, and bio-functionalized with RGD, or RGD/CXCL1. Cell adhesion to star-PEG-coated nitinol foils was unaltered or reduced, whereas bio-functionalization with RGD but foremost RGD/CXCL1 increased adhesion of early angiogenic outgrowth cells (EOCs) and endothelial cells but not smooth muscle cells when compared with bare metal foils. Stimulation of cells with RGD/CXCL1 furthermore increased the proliferation of EOCs. In vivo, bio-functionalization with RGD/CXCL1 significantly reduced neointima formation and thrombus formation, and increased re-endothelialization in apoE-/- carotid arteries compared with bare-metal nitinol stents, star-PEG-coated stents, and stents bio-functionalized with RGD only. Bio-functionalization of star-PEG-coated nitinol-stents with RGD/CXCL1 reduced in-stent neointima formation. By supporting the adhesion and proliferation of endothelial progenitor cells, RGD/CXCL1 coating of stents may help to accelerate endothelial repair after stent implantation, and thus may harbor the potential to limit the complication of in-stent restenosis in clinical approaches.

Targeting In-Stent-Stenosis with RGD- and CXCL1-Coated Mini-Stents in Mice

PubMed Central

Weinandy, Stefan; Schreiber, Fabian; Megens, Remco T. A.; Theelen, Wendy; Smeets, Ralf; Jockenhövel, Stefan; Gries, Thomas; Möller, Martin; Klee, Doris; Weber, Christian; Zernecke, Alma

2016-01-01

Atherosclerotic lesions that critically narrow the artery can necessitate an angioplasty and stent implantation. Long-term therapeutic effects, however, are limited by excessive arterial remodeling. We here employed a miniaturized nitinol-stent coated with star-shaped polyethylenglycole (star-PEG), and evaluated its bio-functionalization with RGD and CXCL1 for improving in-stent stenosis after implantation into carotid arteries of mice. Nitinol foils or stents (bare metal) were coated with star-PEG, and bio-functionalized with RGD, or RGD/CXCL1. Cell adhesion to star-PEG-coated nitinol foils was unaltered or reduced, whereas bio-functionalization with RGD but foremost RGD/CXCL1 increased adhesion of early angiogenic outgrowth cells (EOCs) and endothelial cells but not smooth muscle cells when compared with bare metal foils. Stimulation of cells with RGD/CXCL1 furthermore increased the proliferation of EOCs. In vivo, bio-functionalization with RGD/CXCL1 significantly reduced neointima formation and thrombus formation, and increased re-endothelialization in apoE-/- carotid arteries compared with bare-metal nitinol stents, star-PEG-coated stents, and stents bio-functionalized with RGD only. Bio-functionalization of star-PEG-coated nitinol-stents with RGD/CXCL1 reduced in-stent neointima formation. By supporting the adhesion and proliferation of endothelial progenitor cells, RGD/CXCL1 coating of stents may help to accelerate endothelial repair after stent implantation, and thus may harbor the potential to limit the complication of in-stent restenosis in clinical approaches. PMID:27192172

Self-Expandable Metallic Stent Placement in Malignant Gastric Outlet Obstruction

PubMed Central

Ye, Bing-Wei; Lee, Kuei-Chuan; Hsieh, Yun-Cheng; Li, Chung-Pin; Chao, Yee; Hou, Ming-Chih; Lin, Han-Chieh

2015-01-01

Abstract Malignant gastric outlet obstruction is a late complication of intraabdominal malignancy. Self-expandable metallic stent placement has been a safe palliative treatment to relieve obstructive symptoms. We aimed to assess the efficacy and safety of metallic stents in our patients and analyzed the clinical outcome of different brands. Seventy-one patients with inoperable gastric outlet obstruction receiving WallFlex enteral stents (WallFlex group) or Bonastents (Bonastent group) since April 2010 were analyzed retrospectively. The overall technical and clinical success rates of stent placement were 100% and 93%, respectively. The baseline characteristics and clinical outcomes including procedure-related complications, restenosis, and reintervention rates were comparable between the 2 groups. However, the Bonastent group had a higher rate of stent fracture than the WallFlex group (13.3% vs 0%, P = 0.03). The mean duration of overall stent patency was 132.7 days. The mean duration of survival was 181.9 days. Resumption of regular diet or low residual diet at day 7 after stent insertion predicted stent patency (hazard ratio [HR]: 0.28, P = 0.01). Cancer with gastric origin (HR: 0.25, P = 0.045) and poststent chemotherapy (HR: 0.38, P = 0.006) predicted lower mortality; however, peritoneal carcinomatosis (HR: 3.09, P = 0.04) correlated with higher mortality. Metallic stent placement is a safe and effective method for relieving gastric outlet obstruction. Except higher rate of stent fracture in the Bonastent group, there is no significant difference in clinical outcomes between the Bonastent group and the WallFlex group. PMID:26200641

Hepatocellular Carcinoma Complicated by Gastroduodenal Obstruction: Palliative Treatment with Metallic Stent Placement

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lee, Ye Jin; Kim, Jin Hyoung, E-mail: m1fenew@daum.net; Song, Ho-Young

Purpose: To evaluate the clinical effectiveness of self-expandable metallic stents in seven patients with malignant gastroduodenal obstruction caused by inoperable hepatocellular carcinoma (HCC). Methods: Seven patients with gastroduodenal obstruction caused by advanced HCC underwent metallic stent placement from 2003 to 2010. These patients had total dysphagia (n = 5) or were able to eat only liquids (n = 2) before stent placement. Patients had Eastern Cooperative Oncology Group performance scores of 2 or 3, and Child-Pugh classification B or C. Results: Stent placement was technically successful in all seven patients (100%) and clinically successful in six (86%). Five patients couldmore » eat a soft diet, and one patient tolerated regular diet after stent placement. Stent-related obstructive jaundice occurred in one patient. One patient had hematemesis 11 days after stent placement. Overall mean survival was 51 days (range, 10-119 days). Stent patency was preserved in six patients with clinical success until death. Conclusion: Placement of a covered self-expandable metallic stent may offer good palliation in patients with gastroduodenal obstruction due to advanced HCC.« less

Effect of Covered Metallic Stents Compared With Plastic Stents on Benign Biliary Stricture Resolution

PubMed Central

Coté, Gregory A.; Slivka, Adam; Tarnasky, Paul; Mullady, Daniel K.; Elmunzer, B. Joseph; Elta, Grace; Fogel, Evan; Lehman, Glen; McHenry, Lee; Romagnuolo, Joseph; Menon, Shyam; Siddiqui, Uzma D.; Watkins, James; Lynch, Sheryl; Denski, Cheryl; Xu, Huiping; Sherman, Stuart

2017-01-01

IMPORTANCE Endoscopic placement of multiple plastic stents in parallel is the first-line treatment for most benign biliary strictures; it is possible that fully covered, self-expandable metallic stents (cSEMS) may require fewer endoscopic retrograde cholangiopancreatography procedures (ERCPs) to achieve resolution. OBJECTIVE To assess whether use of cSEMS is noninferior to plastic stents with respect to stricture resolution. DESIGN, SETTING, AND PARTICIPANTS Multicenter (8 endoscopic referral centers), open-label, parallel, randomized clinical trial involving patients with treatment-naive, benign biliary strictures (N = 112) due to orthotopic liver transplant (n = 73), chronic pancreatitis (n = 35), or postoperative injury (n = 4), who were enrolled between April 2011 and September 2014 (with follow-up ending October 2015). Patients with a bile duct diameter less than 6 mm and those with an intact gallbladder in whom the cystic duct would be overlapped by a cSEMS were excluded. INTERVENTIONS Patients (N = 112) were randomized to receive multiple plastic stents or a single cSEMS, stratified by stricture etiology and with endoscopic reassessment for resolution every 3 months (plastic stents) or every 6 months (cSEMS). Patients were followed up for 12 months after stricture resolution to assess for recurrence. MAIN OUTCOMES AND MEASURES Primary outcome was stricture resolution after no more than 12 months of endoscopic therapy. The sample size was estimated based on the noninferiority of cSEMS to plastic stents, with a noninferiority margin of −15%. RESULTS There were 55 patients in the plastic stent group (mean [SD] age, 57 [11] years; 17 women [31%]) and 57 patients in the cSEMS group (mean [SD] age, 55 [10] years; 19 women [33%]). Compared with plastic stents (41/48, 85.4%), the cSEMS resolution rate was 50 of 54 patients (92.6%), with a rate difference of 7.2% (1-sided 95% CI, −3.0% to ∞; P < .001). Given the prespecified noninferiority margin of −15%, the

Successful removal of self-expanding metallic stent after deployment for tubercular bronchostenosis.

PubMed

Isaac, Barney Thomas Jesudason; Datey, Ashima; Christopher, Devasahayam Jesudas

2016-01-01

The use of metallic stents is traditionally not recommended for benign tracheobronchial conditions. With advances in the field of interventional bronchoscopy, metal tracheobronchial stents have occasionally been used to treat benign disease. However, the removal of these stents from the airway is technically difficult. We are reporting the case of a young female subject who received a self-expanding metallic stent for alleviation of post-tubercular bronchostenosis, which was successfully removed after two months without complications. Metal stents can be used in benign tracheobronchial conditions but require meticulous follow-up to monitor complications. Experienced operators can remove them without major complications and this may be life-saving in emergencies. We are reporting this case for the rarity of such procedures in India. Copyright © 2015 Tuberculosis Association of India. Published by Elsevier B.V. All rights reserved.

Biodegradable metals for cardiovascular stents: from clinical concerns to recent Zn - alloys

PubMed Central

Bowen, Patrick K.; Shearier, Emily R.; Zhao, Shan; Guillory, Roger J.; Zhao, Feng; Goldman, Jeremy; Drelich, Jaroslaw W.

2016-01-01

Metallic stents are commonly used to promote revascularization and maintain patency of plaqued or damaged arteries following balloon angioplasty. To mitigate the long-term side effects associated with corrosion-resistant stents (i.e. chronic inflammation and late stage thrombosis), a new generation of so-called “bioabsorbable” stents is currently being developed. The bioabsorbable coronary stents will corrode and be absorbed by the artery after completing their task as vascular scaffolding. Research spanning the last two decades has focused on biodegradable polymeric, iron-based, and magnesium-based stent materials. The inherent mechanical and surface properties of metals make them more attractive stent material candidates than their polymeric counterparts. Unfortunately, iron produces a voluminous, retained oxide product in the arterial wall, whereas magnesium and its alloys corrode too rapidly. A third class of metallic bioabsorbable materials that are based on zinc has been introduced in the last few years. As summarized in this contribution, this new zinc-based class of materials demonstrates the potential for an absorbable metallic stent with the mechanical and biodegradation characteristics required for optimal stent performance. They appear to be free of flaws that limit the application of iron- and magnesium-based alloys, and polymers. This review compares bioabsorbable materials and summarizes progress towards bioabsorbable stents. It emphasizes on current understanding of physiological and biological benefits of zinc and its biocompatibility. Finally, the review provides an outlook on challenges in designing zinc-based stents of optimal mechanical properties and biodegradation rate. PMID:27094868

Sequential Stenting for Extensive Malignant Airway Stenosis

PubMed Central

Takahama, Makoto; Nakajima, Ryu; Kimura, Michitaka; Tei, Keiko; Yamamoto, Ryoji

2014-01-01

Purpose: Malignant airway stenosis extending from the bronchial bifurcation to the lower lobar orifice was treated with airway stenting. We herein examine the effectiveness of airway stenting for extensive malignant airway stenosis. Methods: Twelve patients with extensive malignant airway stenosis underwent placement of a silicone Dumon Y stent (Novatech, La Ciotat, France) at the tracheal bifurcation and a metallic Spiral Z-stent (Medico’s Hirata, Osaka, Japan) at either distal side of the Y stent. We retrospectively analyzed the therapeutic efficacy of the sequential placement of these silicone and metallic stents in these 12 patients. Results: The primary disease was lung cancer in eight patients, breast cancer in two patients, tracheal cancer in one patient, and thyroid cancer in one patient. The median survival period after airway stent placement was 46 days. The Hugh–Jones classification and performance status improved in nine patients after airway stenting. One patient had prolonged hemoptysis and died of respiratory tract hemorrhage 15 days after the treatment. Conclusion: Because the initial disease was advanced and aggressive, the prognosis after sequential airway stent placement was significantly poor. However, because respiratory distress decreased after the treatment in most patients, this treatment may be acceptable for selected patients with extensive malignant airway stenosis. PMID:25273272

Management of occluded self-expanding biliary metal stents in malignant biliary disease.

PubMed

Nennstiel, Simon; Tschurtschenthaler, Isolde; Neu, Bruno; Algül, Hana; Bajbouj, Monther; Schmid, Roland M; von Delius, Stefan; Weber, Andreas

2018-02-01

Occlusion of self-expanding metal stents (SEMS) in malignant biliary obstruction occurs in up to 40% of patients. This study aimed to compare the different techniques to resolve stent occlusion in our collective of patients. Patients with malignant biliary obstruction and occlusion of biliary metal stent at a tertiary referral endoscopic center were retrospectively identified between April 1, 1994 and May 31, 2014. The clinical records were further analyzed regarding the characteristics of patients, malignant strictures, SEMS, management strategies, stent patency, subsequent interventions, survival time and case charges. A total of 108 patients with biliary metal stent occlusion were identified. Seventy-nine of these patients were eligible for further analysis. Favored management was plastic stent insertion in 73.4% patients. Second SEMS were inserted in 12.7% patients. Percutaneous transhepatic biliary drainage and mechanical cleansing were conducted in a minority of patients. Further analysis showed no statistically significant difference in median overall secondary stent patency (88 vs. 143 days, P = 0.069), median survival time (95 vs. 192 days, P = 0.116), median subsequent intervention rate (53.4% vs. 40.0%, P = 0.501) and median case charge (€5145 vs. €3473, P = 0.803) for the treatment with a second metal stent insertion compared to plastic stent insertion. In patients with survival time of more than three months, significantly more patients treated with plastic stents needed re-interventions than patients treated with second SEMS (93.3% vs. 57.1%, P = 0.037). In malignant biliary strictures, both plastic and metal stent insertions are feasible strategies for the treatment of occluded SEMS. Our data suggest that in palliative biliary stenting, patients especially those with longer expected survival might benefit from second SEMS insertion. Careful patient selection is important to ensure a proper decision for either management

Application of memory metallic stents to urinary tract disorders in pediatric patients.

PubMed

Kamata, Shinkichi; Usui, Noriaki; Kamiyama, Masafumi; Yoneda, Akihiro; Tazuke, Yuko; Ooue, Takaharu

2005-03-01

The use of memory metallic stents for the urinary tract in pediatric patients has not been reported. The authors report on 2 patients with urinary tract disorders who were successfully treated with a memory metallic stent. A thermoexpandable, nickel-titanium alloy stent was placed at the urethroureteral junction of a 4-year-old boy with ureteral stenosis associated with cloacal exstrophy for 18 months and at the urethra of a 2-year-old girl with ischuria after a repair of cloacal anomaly for 6 months. Temporary insertion of a memory metallic stent is a safe and effective alternative for organic stricture or functional obstruction of the urinary tract in pediatric patients.

Clinical Outcomes of Self-Expandable Metal Stents for Malignant Rectal Obstruction.

PubMed

Lee, Hyun Jung; Hong, Sung Pil; Cheon, Jae Hee; Kim, Tae Il; Kim, Won Ho; Park, Soo Jung

2018-01-01

Self-expandable metal stents are widely used to treat malignant colorectal obstruction. However, data on clinical outcomes of stent placement for rectal obstruction specifically are lacking. We aimed to investigate the clinical outcomes of self-expandable metal stents in malignant rectal obstruction in comparison with those in left colonic obstruction and to identify factors associated with clinical failure and complication. This was a retrospective study. The study was conducted at a tertiary care center. Between January 2005 and December 2013, medical charts of patients who underwent stent placement for malignant rectal or left colonic obstruction were reviewed retrospectively. Study intervention included self-expandable metal stent placement. Technical success, clinical success, and complications were measured. Technical success rates for the 2 study groups (rectum vs left colon, 93.5% vs 93.1%; p = 0.86) did not differ significantly; however, the clinical success rate was lower in patients with rectal obstruction (85.4% vs 92.1%; p = 0.02). In addition, the complication rate was higher in patients with rectal obstruction (37.4% vs 25.1%; p = 0.01). Patients with rectal obstruction showed higher rates of obstruction because of extracolonic malignancy (33.8% vs 15.8%; p < 0.001) and stent use for palliation (78.6% vs 56.3%; p < 0.001). Multivariate analysis indicated obstruction attributed to extracolonic malignancy and covered stent usage to be independent risk factors for clinical failure. Factors predictive of complications in the palliative group were total obstruction, obstruction because of extracolonic malignancy, and covered stent usage. This was a retrospective, single-center study. The efficacy and safety of stent placement for malignant rectal obstruction were comparable with those for left colonic obstruction. However, obstruction attributed to extracolonic malignancy, use of covered stents, and total obstruction negatively impacted clinical outcomes

Endoscopic management of occluded metal biliary stents: metal versus 10F plastic stents.

PubMed

Yoon, Won Jae; Ryu, Ji Kon; Lee, Jung Won; Ahn, Dong-Won; Kim, Yong-Tae; Yoon, Yong Bum; Woo, Sang Myung; Lee, Woo Jin

2010-11-14

To compare the efficacy of self-expandable metal stents (SEMSs) with 10F plastic stents (PSs) in the endoscopic management of occluded SEMSs. We retrospectively reviewed the medical records of 56 patients who underwent SEMS insertion for palliation of unresectable malignant biliary obstruction between 2000 and 2007 and subsequent endoscopic retrograde biliary drainage (ERBD) with SEMS or PS for initial SEMS occlusion between 2000 and 2008. Subsequent ERBD with SEMS was performed in 29 patients and with PS in 27. The median time to stent occlusion after subsequent ERBD was 186 d in the SEMS group and 101 d in the PS group (P = 0.118). Overall median stent patency was 79 d for the SEMS group and 66 d for the PS group (P = 0.379). The mean number of additional biliary drainage procedures after subsequent ERBD in patients that died (n = 50) during the study period was 2.54 ± 4.12 for the SEMS group and 1.85 ± 1.95 for the PS group (P = 0.457). The mean total cost of additional biliary drainage procedures after the occlusion of subsequent SEMS or PS was $410.04 ± 692.60 for the SEMS group and $630.16 ± 671.63 for the PS group (P = 0.260). Tumor ingrowth as the cause of initial SEMS occlusion was the only factor associated with a shorter time to subsequent stent occlusion (101 d for patients with tumor ingrowth vs 268 d for patients without tumor ingrowth, P = 0.008). Subsequent ERBD with PSs offered similar patency and number of additional biliary drainage procedures compared to SEMSs in the management of occluded SEMS.

Long term follow-up of bifurcation aneurysms treated with braided stent assisted coiling and complex T- and Y- stent constructs.

PubMed

Cheung, Nicholas K; Chiu, Albert Hy; Cheung, Andrew; Wenderoth, Jason D

2018-06-01

Stent assisted coil embolization (SACE) of bifurcation aneurysms is challenging. Heterogeneous results have been achieved to date, but largely for laser cut stents. While braided stents offer multiple technical advantages, their long term efficacy has yet to be validated. To report the first long term 18 month results for the durability of bifurcation aneurysms treated with braided stents. Over a 4 year period, 59 consecutive patients with 60 bifurcation aneurysms underwent elective braided SACE across three Australian neurovascular centers. 17 of these aneurysms underwent T- or Y-shaped stent constructs. All patients had immediate, 6 month and 18 month clinical and radiological follow-up. Radiological assessment was made on modified Raymond-Roy occlusion scores while clinical assessment was based on the modified Rankin Scale. Subgroup analysis of 17 aneurysms treated with multi-stent constructs was conducted. 6 month follow-up data were available for 59 aneurysms and 18 month follow-up data for 58 aneurysms. Satisfactory aneurysm occlusion was achieved in 97% at inception and at 6 months, and 98% at 18 months. Good neurological outcomes were achieved in 95% at 18 months. Similar satisfactory results were achieved with the multi-stent construct cohort. Intraprocedural thromboembolic events were recorded in 5% and delayed events in 2%. Technical complications were found in 5%. All complication rate was 13%. Braided SACE was safe, efficacious, and durable at the long term 18 month follow-up, including for multi-stent constructs. Preliminary results indicate favorable clinical and radiological outcomes compared with laser cut stents. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Interventional radiology and the use of metal stents in nonvascular clinical practice: a systematic overview.

PubMed

Pron, G; Common, A; Simons, M; Ho, C S

1999-05-01

The intent of this systematic overview was to describe the clinical role of metal stents in nonvascular health care interventions and the level of evidence supporting their use. Structured searches of Medline were conducted and limited to original peer-reviewed articles published in English. Clinical practice involving metal stents was reported in more than 109 clinical series involving 4,753 patients. Stents were placed mainly for palliation of malignant biliary, esophageal, and airway obstruction in patients who were untreatable or had surgically unresectable lesions. Assessment of these interventions has so far centered on safety and technical success. Efficacy, quality of life, and costing factors were not routinely reported. Randomized trial evidence was available but limited; six randomized trials involving metal stents have been reported. Three trials involved biliary malignant obstruction, and all three reported metal stent (132 patients) palliation to be superior to plastic stent palliation (136 patients) based on longer patency and lower reintervention costs. Safety and complication differences between stents, however, were inconsistent across trials. In three trials involving esophageal malignant obstruction, metal stent (82 patients) palliation was reported to be superior to plastic stent (41 patients), based on lower complication and reintervention rates, and superior to laser therapy (18 patients), based on better dysphagia relief. Use of metal stents has been reported for obstructed ducts and passageways of most body systems. There is, however, limited controlled trial evidence confirming the advantages of their use over plastic stents or other forms of treatment.

The Integrity bare-metal stent made by continuous sinusoid technology.

PubMed

Turco, Mark A

2011-05-01

The Integrity Coronary Stent System (Medtronic Vascular, CA, USA) is a low-profile, open-cell, cobalt-chromium-alloy advanced bare-metal iteration of the well-known Driver/Micro-Driver Coronary Stent System (Medtronic Vascular). The Integrity stent is made with a process called continuous sinusoid technology. This process allows stent construction via wrapping a single thin strand of wire around a mandrel in a sinusoid configuration, with laser fusion of adjacent crowns. The wire-forming process and fusion pattern provide the stent with a continuous preferential bending plane, intended to allow easier access to, and smoother tracking within, distal and tortuous vessels while radial strength is maintained. Continuous sinusoid technology represents innovation in the design of stent platforms and will provide a future stent platform for newer technology, including drug-eluting stent platforms, drug-filled stents and core wire stents.

Metallic ureteral stents in malignant ureteral obstruction: short-term results and radiological features predicting stent failure in patients with non-urological malignancies.

PubMed

Chow, Po-Ming; Hsu, Jui-Shan; Wang, Shuo-Meng; Yu, Hong-Jheng; Pu, Yeong-Shiau; Liu, Kao-Lang

2014-06-01

To provide short-term result of the metallic ureteral stent in patients with malignant ureteral obstruction and identify radiological findings predicting stent failure. The records of all patients with non-urological malignant diseases who have received metallic ureteral stents from July 2009 to March 2012 for ureteral obstruction were reviewed. Stent failure was detected by clinical symptoms and imaging studies. Survival analysis was used to estimate patency rates and factors predicting stent failure. A total of 74 patients with 130 attempts of stent insertion were included. A total of 113 (86.9 %) stents were inserted successfully and 103 (91.2 %) achieved primary patency. After excluding cases without sufficient imaging data, 94 stents were included in the survival analysis. The median functional duration of the 94 stents was 6.2 months (range 3-476 days). Obstruction in abdominal ureter (p = 0.0279) and lymphatic metastasis around ureter (p = 0.0398) were risk factors for stent failure. The median functional durations of the stents for abdominal and pelvic obstructions were 4.5 months (range 3-263 days) and 6.5 months (range 4-476 days), respectively. The median durations of the stents with and without lymphatic metastasis were 5.3 months (range 4-398 days) and 7.8 months (range 31-476 days), respectively. Metallic ureteral stents are effective and safe in relieving ureteral obstructions resulting from non-urological malignancies, and abdominal ureteral obstruction and lymphatic metastasis around ureter were associated with shorter functional duration.

Biomedical engineering in design and application of nitinol stents with shape memory effect

NASA Astrophysics Data System (ADS)

Ryklina, E. P.; Khmelevskaya, I. Y.; Morozova, Tamara V.; Prokoshkin, S. D.

1996-04-01

Our studies in the field of endosurgery in collaboration with the physicians of the National Research Center of Surgery of the Academy of Medical Sciences are carried out beginning in 1983. These studies laid the foundation for the new direction of X-ray surgery--X-ray Nitinol stenting of vessels and tubular structures. X-ray nitinol stents are unique self-fixing shells based on the shape memory effect and superelasticity of nickel-titanium alloys self- reconstructed under human body temperature. Applied for stenting of arteries in cases of stenosis etc., bile ducts in cases of benign and malignant stenoses, digestive tract in cases of oesophageal cancer and cervical canal uterus in cases of postsurgical atresiss and strictures of uterine. The purpose of stenting is restoration of the shape of artery or tubular structure by a cylinder frame formation. The especially elaborated original method of stenting allows to avoid the traditional surgical operation, i.e. the stenting is performed without blood, narcosis and surgical knife. The stent to be implanted is transported into the affected zone through the puncture under the X-ray control. Clinical applications of X-ray endovascular stenting has been started in March 1984. During this period nearly 400 operations on stenting have been performed on femoral, iliac, brachio-cephalic, subclavian arteries, bile ducts, tracheas, digestive tract and cervical canal uterus.

Outcomes of Prosthetic Hemodialysis Grafts after Deployment of Bare Metal versus Covered Stents at the Venous Anastomosis

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kim, Charles Y., E-mail: charles.kim@duke.edu; Tandberg, Daniel J.; Rosenberg, Michael D.

2012-08-15

Purpose: To compare postintervention patency rates after deployment of bare metal versus covered stents across the venous anastomosis of prosthetic arteriovenous (AV) grafts. Methods: Review of our procedural database over a 6 year period revealed 377 procedures involving stent deployment in an AV access circuit. After applying strict inclusion criteria, our study group consisted of 61 stent deployments in 58 patients (median age 58 years, 25 men, 33 women) across the venous anastomosis of an upper extremity AV graft circuit that had never been previously stented. Both patent and thrombosed AV access circuits were retrospectively analyzed. Within the bare metalmore » stent group, 20 of 32 AV grafts were thrombosed at initial presentation compared to 18 of 29 AV grafts in the covered stent group. Results: Thirty-two bare metal stents and 29 covered stents were deployed across the venous anastomosis. The 3, 6, and 12 months primary access patency rates for bare metal stents were not significantly different than for covered stents: 50, 41, and 22 % compared to 59, 52, and 29 %, respectively (p = 0.21). The secondary patency rates were also not significantly different: 78, 78, and 68 % for bare metal stents compared to 76, 69, and 61 % for covered stents, respectively (p = 0.85). However, covered stents demonstrated a higher primary stent patency rate than bare metal stents: 100, 85, and 70 % compared to 75, 67, and 49 % at 3, 6, and 12 months (p < 0.01). Conclusion: The primary and secondary access patency rates after deployment of bare metal versus covered stents at the venous anastomosis were not significantly different. However, bare metal stents developed in-stent stenoses significantly sooner.« less

Malignant Ureteral Obstruction: Functional Duration of Metallic versus Polymeric Ureteral Stents

PubMed Central

Chow, Po-Ming; Chiang, I-Ni; Chen, Chia-Yen; Huang, Kuo-How; Hsu, Jui-Shan; Wang, Shuo-Meng; Lee, Yuan-Ju; Yu, Hong-Jeng; Pu, Yeong-Shiau; Huang, Chao-Yuan

2015-01-01

Background Ureteral obstruction caused by extrinsic compression is often associated with intra-abdominal cancers. Internal drainage with ureteral stents is typically the first-line therapy to relieve such obstructions. Novel designs of ureteral stents made of different materials have been invented to achieve better drainage. In this study, we described the functional outcomes of a Resonance metallic ureteral stent (Cook Medical, Bloomington, Indiana, USA) in patients with malignant ureteral obstruction and compare the functional duration of Resonance stents with regular polymeric stents in the same cohort. Methods Cancer patients who received polymeric stents and subsequent Resonance stents for ureteral obstruction between July 2009 and November 2012 were included in a chart review. Stent failure was detected by clinical symptoms, imaging studies, and renal function tests. The functional durations of each stent were calculated, and possible factors affecting stent patency were investigated. Results A total of 50 stents were successfully inserted into 50 ureteral units in 42 patients with malignant ureteral obstruction. There were 7 antegrade stents and 43 retrograde stents. There were no major complications. Stent-related symptoms were similar in both kinds of stents. After polymeric stents were replaced with Resonance metallic stents, hydronephrosis subsided or remained stable in 90% (45/50) of the ureteral units. Serum creatinine decreased or remained stable in 90% (38/42) of these patients. The Resonance stent exhibited a mean increase in functional duration of 4 months compared with the polymeric stents (p<0.0001), and 50% (25/50) of the Resonance stents exhibited a significant increase in functional duration (more than 3 months). Pre-operative serum creatinine < 2 was associated with a substantial increase in stent duration. Conclusions Resonance stents are effective and safe in relieving malignant ureteral obstructions after polymeric stents failure

The integrated place of tracheobronchial stents in the multidisciplinary management of large post-pneumonectomy fistulas: our experience using a novel customised conical self-expandable metallic stent.

PubMed

Dutau, Hervé; Breen, David Patrick; Gomez, Carine; Thomas, Pascal Alexandre; Vergnon, Jean-Michel

2011-02-01

Stump dehiscence after pneumonectomy is a cause of morbidity and mortality in patients treated for non-small-cell lung carcinoma. Surgical repair remains the treatment of choice but can be postponed or contraindicated. Bronchoscopic techniques may be an option with curative intent or as a bridge towards definitive surgery. The aim of the study is to evaluate the efficacy and the outcome of a new customised covered conical self-expandable metallic stent in the management of large bronchopleural fistulas complicating pneumonectomies. A case series using chart review of non-operable patients presenting with large bronchopleural fistulas (>6mm) post-pneumonectomies as a definitive treatment with curative intent for non-small-cell lung carcinomas and requiring the use of a dedicated conical shaped stent in two tertiary referral centres. Seven patients presenting large post-pneumonectomy fistulas (between 6 and 12 mm) were included. Cessation of the air leak and clinical improvement was achieved in all the patients after stent placement. Stent-related complications (two migrations and one stent rupture) were successfully managed using bronchoscopic techniques in two patients and surgery in one. Mortality, mainly related to overwhelming sepsis, was 57%. Delayed definitive surgery was achieved successfully in three patients (43%). This case series assesses the short-term clinical efficacy of a new customised covered conical self-expandable metallic stent in the multidisciplinary management of large bronchopleural fistulas complicating pneumonectomies in patients deemed non-operable. Long-term benefits are jeopardised by infectious complications. Copyright © 2010 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved.

[Complications and the management of fully covered retrievable metal stent placement in benign tracheal stenosis].

PubMed

Wang, Zheng-yu; Wang, Yong-li; Chen, Guang-li; Liang, Xi-hong; Wang, Zhen-chang; Ma, Jian-zhong; Wu, Guang-zhong; Zhang, Xiao-ping

2012-11-01

To study complications and the management of the use of covered retrievable expandable metallic stents in the treatment of benign tracheal stenosis. Fully covered retrievable metal stents were placed in 21 patients with benign tracheal stenosis. Stent-related complications and the management were reviewed and analysed. Twenty-eight fully covered retrievable metallic stents were successfully placed fluoroscopically in 21 patients. Stents were removed 4 - 12 months [mean (5.5 ± 2.2) mouths] after placement in all patients. Stent-related complications included granulation tissue (n = 18), stent migration (n = 4), stent expectoration (n = 2), halitosis (n = 8), mucous retention (n = 21) and mucus plugging (n = 1). Granulation tissue was removed with a carbon dioxide laser in 2 patients. Stents were replaced for 2 times and 3 times respectively in 2 patients after stent migration and stent expectoration. An additional stent was placed in 2 patients after stent migration. Symptom of halitosis was relieved after prolonged course of systemic antibiotics treatment in 8 patients. Symptom of mucous retention was relieved with nebulized saline and N-acetylcysteine saline inhalation. Mucous plug was expelled after severe coughing after suctioning using an aspirator in one patient. There were statistically significant differences in stricture diameter, rank of tachypnea and pulmonary function (FEV(1)) in all 21 patients before stent insertion and after stents removal. No patient has experienced recurrence during the follow-up period of 1 - 36 months [mean (23.2 ± 8.0) months]. Fully covered retrievable metallic stent may be a safe and effective in benign tracheal stenosis. Stent-related complications may be effectively managed.

Self-expandable metallic stents vs. plastic stents for endoscopic biliary drainage in hepatocellular carcinoma.

PubMed

Chung, Kwang Hyun; Lee, Sang Hyub; Park, Jin Myung; Lee, Jae Min; Ahn, Dong-Won; Ryu, Ji Kon; Kim, Yong-Tae

2015-06-01

The patency of self-expandable metallic stents (SEMS) is known to be better than plastic stents in the palliation of malignant biliary obstruction. However, data are scarce for obstructive jaundice caused by hepatocellular carcinoma (HCC). This study aimed to compare SEMSs and plastic stents for the palliation of obstructive jaundice in unresectable HCC. A total of 96 patients who underwent endoscopic retrograde biliary drainage with SEMSs or plastic stents were included in this retrospective analysis. The rate of successful biliary drainage, adverse events, stent patency duration, and patient survival were compared between the SEMS (n = 36) and plastic stent (n = 60) groups. The rate of successful biliary drainage was similar between the SEMS and plastic stent groups (25/36 [69.4 %] vs. 39/60 [65.0 %]; P = 0.655). Adverse events occurred in 6 patients (16.7 %) in the SEMS group and 13 patients (21.7 %) in the plastic stent group (P = 0.552). The median patency duration was also similar between the two groups (60 vs. 68 days; P = 0.396). The median patient survival was longer in the plastic stent group than in the SEMS group (123 vs. 48 days; P = 0.005). SEMSs were not superior to plastic stents for the palliation of malignant biliary obstruction in HCC with regard to successful drainage, stent patency, and adverse events. Patient survival was better in the plastic stent group. Given the lower cost, plastic stents could be a favorable option for malignant biliary obstruction caused by HCC. © Georg Thieme Verlag KG Stuttgart · New York.

Fluoroscopically guided placement of self-expandable metallic stents and stent-grafts in the treatment of acute malignant colorectal obstruction.

PubMed

Kim, Honsoul; Kim, Seung Hyoung; Choi, Sun Young; Lee, Kwang-Hun; Won, Jong Yoon; Lee, Do Yun; Lee, Jong Tae

2008-12-01

To evaluate the technical feasibility and clinical effectiveness of fluoroscopically guided placement of self-expandable metallic stents and stent-grafts for acute malignant colorectal obstruction. Radiologic images and clinical reports of 42 patients (22 men, 20 women; age range, 28-93 years; median age, 65.5 years) who underwent fluoroscopically guided colorectal stent insertion without endoscopic assistance for acute malignant obstruction were reviewed retrospectively. Eighteen patients received bare stents as a bridge to surgery. Twenty-four patients received 27 insertions of either a bare stent (n = 15) or a stent-graft (n = 12) for palliation. The obstruction was located in the rectum (n = 8), sigmoid (n = 17), descending colon (n = 8), splenic flexure (n = 3), and transverse colon (n = 6). Clinical success, defined as more than 50% dilatation of the stent with subsequent symptomatic improvement, was achieved in 41 of the 42 patients (98%). No major procedure-related complications occurred. Minor complications occurred in eight of the 45 procedures (18%). No perioperative mortalities occurred within 1 month after surgery. In the palliative group, the median stent patency was 62 days (range, 0-1,014 days). There was no statistically significant difference in stent patency between the bare stents (range, 0-855 days; median, 68 days) and stent-grafts (range, 1-1,014 days; median, 81 days). Fluoroscopically guided placement of self-expandable metallic stents and stent-grafts for the relief of acute malignant colorectal obstruction was technically feasible without endoscopic assistance-even in lesions proximal to the splenic flexure and transverse colon-and clinically effective in both bridge to surgery and palliative management.

Effects of cobalt-chromium everolimus eluting stents or bare metal stent on fatal and non-fatal cardiovascular events: patient level meta-analysis

PubMed Central

Sabaté, Manel; Kaiser, Christoph; Brugaletta, Salvatore; de la Torre Hernandez, Jose Maria; Galatius, Soeren; Cequier, Angel; Eberli, Franz; de Belder, Adam; Serruys, Patrick W; Ferrante, Giuseppe

2014-01-01

Objectives To examine the safety and effectiveness of cobalt-chromium everolimus eluting stents compared with bare metal stents. Design Individual patient data meta-analysis of randomised controlled trials. Cox proportional regression models stratified by trial, containing random effects, were used to assess the impact of stent type on outcomes. Hazard ratios with 95% confidence interval for outcomes were reported. Data sources and study selection Medline, Embase, the Cochrane Central Register of Controlled Trials. Randomised controlled trials that compared cobalt-chromium everolimus eluting stents with bare metal stents were selected. The principal investigators whose trials met the inclusion criteria provided data for individual patients. Primary outcomes The primary outcome was cardiac mortality. Secondary endpoints were myocardial infarction, definite stent thrombosis, definite or probable stent thrombosis, target vessel revascularisation, and all cause death. Results The search yielded five randomised controlled trials, comprising 4896 participants. Compared with patients receiving bare metal stents, participants receiving cobalt-chromium everolimus eluting stents had a significant reduction of cardiac mortality (hazard ratio 0.67, 95% confidence interval 0.49 to 0.91; P=0.01), myocardial infarction (0.71, 0.55 to 0.92; P=0.01), definite stent thrombosis (0.41, 0.22 to 0.76; P=0.005), definite or probable stent thrombosis (0.48, 0.31 to 0.73; P<0.001), and target vessel revascularisation (0.29, 0.20 to 0.41; P<0.001) at a median follow-up of 720 days. There was no significant difference in all cause death between groups (0.83, 0.65 to 1.06; P=0.14). Findings remained unchanged at multivariable regression after adjustment for the acuity of clinical syndrome (for instance, acute coronary syndrome v stable coronary artery disease), diabetes mellitus, female sex, use of glycoprotein IIb/IIIa inhibitors, and up to one year v longer duration treatment with dual

Effects of cobalt-chromium everolimus eluting stents or bare metal stent on fatal and non-fatal cardiovascular events: patient level meta-analysis.

PubMed

Valgimigli, Marco; Sabaté, Manel; Kaiser, Christoph; Brugaletta, Salvatore; de la Torre Hernandez, Jose Maria; Galatius, Soeren; Cequier, Angel; Eberli, Franz; de Belder, Adam; Serruys, Patrick W; Ferrante, Giuseppe

2014-11-04

To examine the safety and effectiveness of cobalt-chromium everolimus eluting stents compared with bare metal stents. Individual patient data meta-analysis of randomised controlled trials. Cox proportional regression models stratified by trial, containing random effects, were used to assess the impact of stent type on outcomes. Hazard ratios with 95% confidence interval for outcomes were reported. Medline, Embase, the Cochrane Central Register of Controlled Trials. Randomised controlled trials that compared cobalt-chromium everolimus eluting stents with bare metal stents were selected. The principal investigators whose trials met the inclusion criteria provided data for individual patients. The primary outcome was cardiac mortality. Secondary endpoints were myocardial infarction, definite stent thrombosis, definite or probable stent thrombosis, target vessel revascularisation, and all cause death. The search yielded five randomised controlled trials, comprising 4896 participants. Compared with patients receiving bare metal stents, participants receiving cobalt-chromium everolimus eluting stents had a significant reduction of cardiac mortality (hazard ratio 0.67, 95% confidence interval 0.49 to 0.91; P=0.01), myocardial infarction (0.71, 0.55 to 0.92; P=0.01), definite stent thrombosis (0.41, 0.22 to 0.76; P=0.005), definite or probable stent thrombosis (0.48, 0.31 to 0.73; P<0.001), and target vessel revascularisation (0.29, 0.20 to 0.41; P<0.001) at a median follow-up of 720 days. There was no significant difference in all cause death between groups (0.83, 0.65 to 1.06; P=0.14). Findings remained unchanged at multivariable regression after adjustment for the acuity of clinical syndrome (for instance, acute coronary syndrome v stable coronary artery disease), diabetes mellitus, female sex, use of glycoprotein IIb/IIIa inhibitors, and up to one year v longer duration treatment with dual antiplatelets. This meta-analysis offers evidence that compared with bare metal

Covered self-expandable metal stents for benign biliary tract diseases.

PubMed

Baron, Todd H

2011-05-01

Benign biliary diseases are often managed endoscopically using plastic stents. Benign biliary strictures (BBS) respond to placement of multiple large-bore plastic stents, though requiring multiple procedures to place stents, and to exchange stents to prevent and/or treat stent occlusion. Bile leaks close using plastic stents, which divert bile away from the leak into the duodenum. Covered self-expandable metal stents (CSEMS), intended for palliation of malignant biliary obstruction, have been used to treat benign biliary diseases. Advantages include small predeployment and large postexpansion diameters. Lack of imbedding of the metal into the bile duct wall enables removability. For strictures, one CSEMS is inserted without need for dilation and remains in place for up to 6 months. Successful removal has been reported in all cases. Long-term stricture resolution is achieved in up to 92%. Adverse events include migration and new stricture formation. For treatment of complex bile leaks, the covering and large diameter allow successful closure in nearly all cases. Other uses of CSEMS include treatment of postsphincterotomy bleeding and closure of perforations. CSEMS show promise for treatment of BBS and complex biliary leaks. Successful resolution can be achieved in the majority of patients with the advantage of fewer procedures, which offsets their higher cost.

Endoscopic management of occluded metal biliary stents: Metal versus 10F plastic stents

PubMed Central

Yoon, Won Jae; Ryu, Ji Kon; Lee, Jung Won; Ahn, Dong-Won; Kim, Yong-Tae; Yoon, Yong Bum; Woo, Sang Myung; Lee, Woo Jin

2010-01-01

AIM: To compare the efficacy of self-expandable metal stents (SEMSs) with 10F plastic stents (PSs) in the endoscopic management of occluded SEMSs. METHODS: We retrospectively reviewed the medical records of 56 patients who underwent SEMS insertion for palliation of unresectable malignant biliary obstruction between 2000 and 2007 and subsequent endoscopic retrograde biliary drainage (ERBD) with SEMS or PS for initial SEMS occlusion between 2000 and 2008. RESULTS: Subsequent ERBD with SEMS was performed in 29 patients and with PS in 27. The median time to stent occlusion after subsequent ERBD was 186 d in the SEMS group and 101 d in the PS group (P = 0.118). Overall median stent patency was 79 d for the SEMS group and 66 d for the PS group (P = 0.379). The mean number of additional biliary drainage procedures after subsequent ERBD in patients that died (n = 50) during the study period was 2.54 ± 4.12 for the SEMS group and 1.85 ± 1.95 for the PS group (P = 0.457). The mean total cost of additional biliary drainage procedures after the occlusion of subsequent SEMS or PS was $410.04 ± 692.60 for the SEMS group and $630.16 ± 671.63 for the PS group (P = 0.260). Tumor ingrowth as the cause of initial SEMS occlusion was the only factor associated with a shorter time to subsequent stent occlusion (101 d for patients with tumor ingrowth vs 268 d for patients without tumor ingrowth, P = 0.008). CONCLUSION: Subsequent ERBD with PSs offered similar patency and number of additional biliary drainage procedures compared to SEMSs in the management of occluded SEMS. PMID:21072899

Drug-eluting stents versus bare-metal stents for off-label indications: a propensity score-matched outcome study.

PubMed

Austin, David; Oldroyd, Keith G; McConnachie, Alex; Slack, Rachel; Eteiba, Hany; Flapan, Andrew D; Jennings, Kevin P; Northcote, Robin J; Pell, Alastair C H; Starkey, Ian R; Pell, Jill P

2008-08-01

The US Food and Drug Administration recently concluded that data on off-label drug-eluting stent (DES) safety are limited. However, in actual clinical practice, DES are often used for off-label indications, and observational studies demonstrate that complications are higher when compared with on-label use. We aimed to determine whether clinical outcomes differ after DES and bare-metal stent implantation in a patient cohort defined by DES off-label indications. We used the national revascularization registry in Scotland to identify patients who underwent coronary stenting for an off-label indication between January 2003 and September 2005. Individual-level linkage to comprehensive national admission and death databases was used to ascertain the end points of death, myocardial infarction, and target-vessel revascularization. We calculated propensity scores on the basis of clinical, demographic, and angiographic variables and matched DES to bare-metal stents on a 1:1 basis. The final study population consisted of 1642 patients, well matched for important covariables at baseline. Event-free survival was calculated over 24 months with the Kaplan-Meier method. All-cause death was more common after bare-metal stent implantation during follow-up (7.7% versus 6.6%; hazard ratio 0.63; 95% confidence interval, 0.40 to 0.99; P=0.04). No difference in the rates of myocardial infarction were noted (7.3% versus 7.5%; hazard ratio 1.02; 95% confidence interval, 0.69 to 1.54; P=0.92). Target-vessel revascularization was reduced in patients treated with DES (13.9% versus 10.7%; hazard ratio 0.67; 95% confidence interval, 0.49 to 0.93; P=0.02). At 24 months, patients treated with DES for off-label indications had lower rates of death and target-vessel revascularization and similar rates of myocardial infarction, as compared with patients treated with bare-metal stents.

Pneumoperitoneum Caused by Transhepatic Air Leak After Metallic Biliary Stent Placement

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lee, Jei Hee; Lee, Deok Hee; Yu, Jeong-Sik

2000-11-15

A self-expanding metallic biliary stent was placed for palliation of a common bile duct obstruction in a 68-year-old male with unresectable pancreatic head cancer 3 days after initial percutaneous right transhepatic catheter decompression. The stent crossed the ampulla of Vater. Three days later, the stent was balloon-dilated and the percutaneous access was removed. At removal, a small contrast leak from the transhepatic tract was seen. Three days later, pneumoperitoneum was found with symptoms of peritoneal irritation and fever. A widely open sphincter of Oddi caused by the metallic stent, accompanied by delayed sealing of the transhepatic tract, may have causedmore » the air and bile leakage into the peritoneal space. This case shows that pneumoperitoneum may occur without ductal tear or bowel injury, with a biliary stent crossing the ampulla of Vater.« less

[Expandable metal mesh stents for treatment of tracheal stenoses and tracheomalacia].

PubMed

Müller, C; Dienemann, H; Hoffmann, H; Berger, H; Storck, M; Jolk, A; Schildberg, F W

1993-01-01

The treatment of tracheo-bronchial stenosis or tracheomalacia is mainly carried out by means of resection or tracheoplastic operative strategies. Since the introduction of metal-mesh stents, a definitive endoluminal therapy has to be considered under new aspects. Six patients with malignant stenosis or tracheomalacia due to compression were treated by implantation of Palmaz- or Wallstents. Immediately after the implantation, patients were relieved from dyspnoea, the forced inspiratory volume-1 (FIV1) was normalized. All implanted stents were well tolerated, even in the long-time follow-up (19 months). Bronchoscopic control showed overgrowth of the metal meshes by respiratory epithelium. The implantation of metal-mesh stents is an adequate alternative in the treatment of malignant stenosis and tracheomalacia.

[Clinical application of a fully covered self-expandable metallic stent in treatment of airway fistula].

PubMed

Zhu, Qiang; Zang, Qi; Jiang, Zhong-min; Wang, Wei; Cao, Ming

2013-06-01

To assess the feasibility, safety and efficacy of the use of a fully covered self-expandable stent for the treatment of airway fistula. From August 2005 to November 2011, 9 patients underwent treatment by the introduction of a tracheo-bronchial or bronchial fully covered self-expandable metallic stent. There were 7 males and 2 females, aged from 28-65 years with a mean of 46 years. In this group, 7 cases were diagnosed as bronchopleural fistula, 1 case as tracheopleural fistula, 1 case as broncho-esophageal fistula, 8 cases with thoracic empyema. The fistula orifices were from 3.5-25.0 mm in diameter with a mean 8.4 mm. All patients received topical anesthesia, and L-shaped stent was placed in 6 patients and I-shaped stent in 3 patients under fluoroscopic guidance. After the stent placement, the patients with empyema were treated with continual irrigation of the empyema cavity. Stent placement in the tracheo-bronchial tree was technically successful in all patients, without procedure-related complications. The operating time was from 5-16 minutes, mean time (10 ± 4) minutes. Except for 1 patient, immediate closure of the airway fistula was achieved in the other patients after the procedure, as shown by the immediate cessation of bubbling in the chest drain system or the contrast examination. In this study, 1 patient coughed the inserted stent out due to irritable cough on the 5th day and had to receive repositioning of a new stent. Among the patients who were with empyema, 1 patient died of septicemia on the 8th day and 1 patient died of brain metastases from lung cancer 6 months after the stent insertion with empyema not cured, the other 6 patients' empyema healed from 2-5 months, mean time 3.7 months. Seven patients were followed from 3 to 36 months with a median of 13.5 months. During follow-up, 1 stent was removed from a patient 8 months after the stent implantation without empyema recurred. The remaining patient presented good tolerability to the existence of

Thoracic Discitis as a Complication of Self-Expanding Metallic Stents in Esophageal Carcinoma

DOE Office of Scientific and Technical Information (OSTI.GOV)

McQueen, A. S.; Eljabu, W.; Latimer, J., E-mail: joanne.latimer@nth.nhs.uk

2011-02-15

The role of metallic stents in the palliation of esophageal cancer is well established. Self-expanding metal stents (SEMSs) are frequently used, as they provide an effective and safe method of relieving malignant dysphagia. A number of complications are associated with the use of SEMSs, including esophageal perforation. We report a case of thoracic discitis occurring in a patient with advanced esophageal malignancy, treated with SEMSs. We propose that the likely etiology in this patient was esophageal perforation by a metallic stent.

Endoscopic ultrasound-guided biliary drainage using a newly designed metal stent with a thin delivery system: a preclinical study in phantom and porcine models.

PubMed

Minaga, Kosuke; Kitano, Masayuki; Itonaga, Masahiro; Imai, Hajime; Miyata, Takeshi; Yamao, Kentaro; Tamura, Takashi; Nuta, Junya; Warigaya, Kenji; Kudo, Masatoshi

2017-12-08

This study was designed to evaluate the feasibility and safety of a newly designed self-expandable metal stent for endoscopic ultrasound-guided biliary drainage (EUS-BD) when it was delivered via three different stent delivery systems: a 7.5Fr delivery catheter with a bullet-shaped tip (7.5Fr-bullet), a 7Fr catheter with a bullet-shaped tip (7Fr-bullet), or a 7Fr catheter with a tee-shaped tip (7Fr-tee). This experimental study utilized a porcine model of biliary dilatation involving ten pigs. In the animal study, technical feasibility and clinical outcomes of the stent when placed with each of the delivery systems were examined. In addition, a phantom model was used to measure the resistance of these delivery systems to advancement. Phantom experiments showed that, compared with 7Fr-bullet, 7Fr-tee had less resistance force to the advancement of the stent delivery system. EUS-BD was technically successful in all ten pigs. Fistulous tract dilation was necessary in 100% (2/2), 75% (3/4), and 0% (0/4) of the pigs that underwent EUS-BD using 7.5Fr-bullet, 7Fr-bullet, and 7Fr-tee, respectively. There were no procedure-related complications. Our newly designed metal stent may be feasible and safe for EUS-BD, particularly when delivered by 7Fr-tee, because it eliminates the need for fistulous tract dilation.

Long-term outcome of self expandable metal stents for biliary obstruction in chronic pancreatitis.

PubMed

Waldthaler, Alexander; Schütte, Kerstin; Weigt, Jochen; Kropf, Siegfried; Malfertheiner, Peter; Kahl, Stefan

2013-01-10

Insertion of a self-expandable metal stent is still controversial for treatment of benign common bile duct stenosis but can be a valuable alternative to surgical treatment. Aim of our study was to analyze the efficacy of covered and uncovered self-expandable metal stent in patients with chronic pancreatitis and common bile duct stenosis. Twenty patients with common bile duct stenosis due to alcoholic chronic pancreatitis were retrospective analyzed. All patients had advanced chronic pancreatitis, presenting with calcifications in pancreatic head. Uncovered self-expandable metal stent (uSEMS) were used in 11 patients (3 females, 8 males) while in 9 patients (3 females, 6 males) partially covered self-expandable metal stent (cSEMS) were inserted. All patients treated with self-expandable metal stent had contraindications for surgery. Overall mean follow up time was 155 weeks: 206 (52-412) weeks in uSEMS, and 93 (25-233) weeks in cSEMS, respectively. Stent patency was in mean 118 weeks: 159 (44-412) weeks in uSEMS and 67 (25-150) weeks in cSEMS (P=0.019). In the uSEMS group, reintervention was necessary in 5 patients (45%) due to stent obstruction, whereas in the cSEMS group 4 patients (44%) needed reintervention (2 obstructions, 2 migration). Stent migration is an early complication, compared to obstruction (P<0.05), and in cSEMS obstruction occurred significantly earlier compared to uSEMS (P<0.05). Patency of uSEMS was significantly longer compared to partially cSEMS. Available self-expandable metal stent, unfortunately, do not meet the demands on successful treatment of benign common bile duct stenosis.

Covered versus uncovered self-expandable metal stents for malignant biliary strictures: A meta-analysis and systematic review.

PubMed

Moole, Harsha; Bechtold, Matthew L; Cashman, Micheal; Volmar, Fritz H; Dhillon, Sonu; Forcione, David; Taneja, Deepak; Puli, Srinivas R

2016-09-01

Self-expandable metal stents (SEMS) are used for palliating inoperable malignant biliary strictures. It is unclear if covered metal stents are superior to uncovered metal stents in these patients. We compared clinical outcomes in patients with covered and uncovered stents. Studies using covered and uncovered metallic stents for palliation in patients with malignant biliary stricture were reviewed. Articles were searched in MEDLINE, PubMed, and Ovid journals. Fixed and random effects models were used to calculate the pooled proportions. Initial search identified 1436 reference articles, of which 132 were selected and reviewed. Thirteen studies (n = 2239) for covered and uncovered metallic stents which met the inclusion criteria were included in this analysis. Odds ratio for stent occlusion rates in covered vs. uncovered stents was 0.79 (95 % CI = 0.65 to 0.96). Survival benefit in patients with covered vs. uncovered stents showed the odds ratio to be 1.29 (95 % CI = 0.95 to 1.74). Pooled odds ratio for migration of covered vs. uncovered stents was 9.9 (95 % CI = 4.5 to 22.3). Covered stents seemed to have significantly lesser occlusion rates, increased odds of migration, and increased odds of pancreatitis compared to uncovered stents. There was no statistically significant difference in the survival benefit, overall adverse event rate, and patency period of covered vs. uncovered metal stents in patients with malignant biliary strictures.

Treatment of cuff-related tracheal stenosis with a fully covered retrievable expandable metallic stent.

PubMed

Chen, G; Wang, Z; Liang, X; Wang, Y; Wang, Y; Wang, Z; Xian, J

2013-04-01

To investigate the clinical effectiveness, complications, and optimal duration of use of covered retrievable expandable metallic stents in the management of cuff-related tracheal stenosis. Twenty-one patients with cuff-related tracheal stenosis, Meyer-Cotton grade II (29%) and III (71%), who underwent fluoroscopically guided placement of covered retrievable expandable metallic stents were studied. Sixty-four-section computed tomography (CT) and bronchovideoscopy were performed prior to stent insertion, 1 month after stent insertion, in the case of stent-related complications, and after stent removal. Clinical manifestations, Hugh-Jones classification, and forced expiratory volume in 1 s (FEV1) were used to evaluate respiratory function before and after stent insertion and removal. The diameter of the stricture and FEV1 changes before insertion and after removal were analysed using the paired samples t-test. A p-value of ≤0.05 was considered statistically significant. Twenty-one patients had 27 covered retrievable expandable metallic stents placed. Stents were electively removed from 20 patients. The median duration of stent placement was 5 months (range 4-12 months). One stent was not removed due to mucopolysaccharidosis type II (MPS II or Hunter syndrome) with tracheomalacia. After stent removal, airway dimensions increased and airway occlusion was symptomatically relieved in all patients. CT and bronchovideoscopy showed patent lumens with increased dimensions. Stent-related complications occurred in 19 (91%) patients, including granulation tissue formation (n = 18, 86%), stent migration and stent expectoration (n = 2, 10%), mucus plugging (n = 1, 5%), and halitosis (n = 6, 29%). Some patients experienced multiple complications, which were all managed effectively while the stent was still in place. There was a statistically significant difference in the diameter of the stricture and FEV1 between the time of stent insertion and removal. An improvement in

Biliary and pancreatic stenting: Devices and insertion techniques in therapeutic endoscopic retrograde cholangiopancreatography and endoscopic ultrasonography

PubMed Central

Mangiavillano, Benedetto; Pagano, Nico; Baron, Todd H; Arena, Monica; Iabichino, Giuseppe; Consolo, Pierluigi; Opocher, Enrico; Luigiano, Carmelo

2016-01-01

Stents are tubular devices made of plastic or metal. Endoscopic stenting is the most common treatment for obstruction of the common bile duct or of the main pancreatic duct, but also employed for the treatment of bilio-pancreatic leakages, for preventing post- endoscopic retrograde cholangiopancreatography pancreatitis and to drain the gallbladder and pancreatic fluid collections. Recent progresses in techniques of stent insertion and metal stent design are represented by new, fully-covered lumen apposing metal stents. These stents are specifically designed for transmural drainage, with a saddle-shape design and bilateral flanges, to provide lumen-to-lumen anchoring, reducing the risk of migration and leakage. This review is an update of the technique of stent insertion and metal stent deployment, of the most recent data available on stent types and characteristics and the new applications for biliopancreatic stents. PMID:26862364

Bare Metal Stenting for Endovascular Exclusion of Aortic Arch Thrombi

DOE Office of Scientific and Technical Information (OSTI.GOV)

Mahnken, Andreas H., E-mail: mahnken@med.uni-marburg.de; Hoffman, Andras; Autschbach, Ruediger

BackgroundAortic thrombi in the ascending aorta or aortic arch are rare but are associated with a relevant risk of major stroke or distal embolization. Although stent grafting is commonly used as a treatment option in the descending aorta, only a few case reports discuss stenting of the aortic arch for the treatment of a thrombus. The use of bare metal stents in this setting has not yet been described.MethodsWe report two cases of ascending and aortic arch thrombus that were treated by covering the thrombus with an uncovered stent. Both procedures were performed under local anesthesia via a femoral approach.more » A femoral cutdown was used in one case, and a total percutaneous insertion was possible in the second case.ResultsBoth procedures were successfully performed without any periprocedural complications. Postoperative recovery was uneventful. In both cases, no late complications or recurrent embolization occurred at midterm follow-up, and control CT angiography at 1 respectively 10 months revealed no stent migration, freely perfused supra-aortic branches, and no thrombus recurrence.ConclusionTreating symptomatic thrombi in the ascending aorta or aortic arch with a bare metal stent is feasible. This technique could constitute a minimally invasive alternative to a surgical intervention or complex endovascular therapy with fenestrated or branched stent grafts.« less

The use of balloon-expandable metallic stents in the treatment of pediatric tracheomalacia and bronchomalacia.

PubMed

Furman, R H; Backer, C L; Dunham, M E; Donaldson, J; Mavroudis, C; Holinger, L D

1999-02-01

To evaluate the use of balloon-expandable metallic stents in the treatment of children with tracheomalacia and bronchomalacia in whom conventional therapy has failed. Retrospective case series. Tertiary pediatric otolaryngology and cardiothoracic surgery referral center. Six patients were identified as having undergone bronchoscopic placement of metallic balloon-expandable stents between 1994 and 1997. The age at stent placement, prior surgical interventions, and indications for and sites of stent placement were noted. Also, the complications related to stent placement and the current airway status of the patients were reviewed. Twelve balloon-expandable metallic angioplasty stents (Palmaz; Johnson & Johnson Interventional Systems Co, Warren, NJ) were placed bronchoscopically in 6 patients. Six stents were placed in the lower trachea, and 6 were placed in the main bronchi. The stents were balloon expanded under fluoroscopic guidance. Discontinuation of mechanical ventilation. The age at stent placement ranged from 1.5 to 38 months (mean age at placement, 10 months). The indications for stent placement were (1) tracheomalacia or bronchomalacia, (2) pericardial patch or slide tracheoplasty failure, and (3) bronchomalacia caused by tetralogy of Fallot and large pulmonary arteries. The primary complication of stent placement was postoperative granulation tissue formation. One patient required the removal of 2 tracheal stents because of granulation tissue formation. There were 2 deaths in the series, 1 possibly related to stent placement. Four of the 6 patients were weaned from mechanical ventilation, and 3 experienced prolonged relief of airway obstruction. Metallic balloon-expandable stents are effective in relieving lower tracheomalacia and bronchomalacia in select patients. Only patients in whom conventional therapy has failed should be considered for stent placement.

Safety and efficacy of self-expandable metal stents for obstructive proximal and distal large bowel cancer.

PubMed

Mitra, V; Hu, M; Majumdar, D; Krishnan, V; Chaudhury, B; Hancock, J; Dwarakanath, D

2017-03-01

Self-expandable metal stents are often used to treat obstructive large bowel cancers. This study assessed the safety and efficacy of colonic stent insertion carried out in a district general hospital. Methods A retrospective review was carried out between 1 January 2007 and 28 February 2014 to identify patients who underwent stent insertion for malignant colorectal obstruction. Results Seventy-five patients (median age 75.2 years, 70.6% male) with primary colorectal cancer underwent stent insertion - 53 underwent semi-elective self-expanded metal stent insertion (for subacute bowel obstruction) and 22 had emergency stent inserted (for acute bowel obstruction). The majority (88%) had self-expanded metal stents inserted for palliation. Technical and clinical success rates were 98.7% and 91.2%, respectively. One patient had stent-related perforation; there was no procedure-related mortality. Conclusion This study shows that self-expanded metal stent insertion in malignant colorectal obstruction is safe and effective and can be successfully delivered in a district general hospital with high technical and clinical success rates.

[Assessment of the course of ischemic heart disease after placement of stents with drug covering and uncovered metal stents: data of 3 years follow-up].

PubMed

Buza, V V; Karpov, Iu A; Samko, A N; Deev, A D; Lopukhova, V V; Levitskiĭ, I V; Sozykin, A V

2009-01-01

The placement of sirolimus-eluting stents decreases the frequency of repeat revascularization procedures in patients undergoing percutaneous coronary intervention (PCI) in randomized clinical trials. However, there is uncertainty about the effectiveness of sirolimus-eluting stents, and increasing concern about their safety in routine clinical practice. From the prof. Samko PCI laboratory in Moscow, Russia, we identified 426 patients, who received either bare-metal stents alone or sirolimus-eluting stents alone during an index PCI procedure between March 1, 2002, and September 31, 2004.The primary outcomes of the study were the rates of target-lesion revascularization, myocardial infarction, death, late stent thrombosis. The 3-year rate of target-lesion revascularization was significantly lower among patients who received sirolimus-eluting stents than among those who received bare-metal stents (3.1% vs. 19 %, p=0.001). The 3-year mortality rate was not different between the bare-metal stent group and the sirolimus eluting stent group (5.9% vs. 7.2%, p=0.68), the 3-year rate of all ARC late stent thrombosis was similar in the two groups (5.9% and 7.2%, respectively; p=0.95). Sirolimus-eluting stents are effective in reducing the need for target-vessel revascularization without significantly increased rates of death, late stent thrombosis, myocardial infarction.

The use of expandable metallic airway stents for tracheobronchial obstruction in children.

PubMed

Filler, R M; Forte, V; Fraga, J C; Matute, J

1995-07-01

Expandable metallic angioplasty stents (Palmaz stent) have been implanted in the trachea and/or bronchi of seven children. Three children had severe tracheal stenosis after tracheoplasty for congenital tracheal stenosis repair, and four had tracheomalacia or bronchomalacia with or without vascular compression. The mean age at stenting was 9.7 months (range, 2 to 15 months). Balloon expandable stents were inserted into the trachea or bronchus through a 3.5-mm bronchoscope under fluoroscopic control. Initially a single tracheal stent was used for all patients except for one with obstruction in the trachea and both bronchi, in whom three stents were implanted. Three children had recurrent airway obstruction 1 month later; one was cured with a second stent; one child died 1 year later; and the other is being treated for heart disease. The others have no serious respiratory problems. The stents in all have been in place for 1 to 25 (mean, 11) months. No immediate complications were noted. Early and late bronchoscopy showed incomplete epithelialization of the stent and patches of granulation tissue on it. Two stents were removed bronchoscopically, one at the completion of treatment for tracheomalacia and the other at the time of recurrent airway obstruction. This preliminary experience indicates that expandable metallic stents have a useful role in the treatment of selected lower airway obstructions.

Use of a retrievable metallic stent internally coated with silicone to treat airway obstruction.

PubMed

Kim, Jin Hyoung; Shin, Ji Hoon; Song, Ho-Young; Lee, Se Chul; Kim, Kyung Rae; Park, Jung-Hoon

2008-08-01

The authors hypothesized that internally covered stents can reduce the rates of stent migration or mucous retention. The authors performed this study to report their experience with use of a retrievable metallic stent internally coated with silicone in patients with benign or malignant central airway obstructions. From 2004 to 2007, the authors performed fluoroscopically guided placement of a retrievable metallic stent internally coated with silicone in 26 consecutive patients with benign (n = 5) and malignant (n = 21) central airway obstructions. Stents were woven from a single thread of a 0.2-mm-diameter nitinol wire in a tubular configuration and internally covered with silicone membrane. Stent placement was technically and clinically successful in 93% (25/26) and 85% (22/26) of the patients, respectively. There were eight complications (31%) after stent placement, including tumor overgrowth (n = 2), stent migration (n = 1), symptomatic granulation tissue formation (n = 1), severe pain (n = 1), improper stent location (n = 1), symptomatic sputum retention (n = 1) and esophagobronchial fistula (n = 1). Because of complications, five stents were removed with a retrieval hook under fluoroscopic guidance without difficulty. The median survival period and stent patency were 150.0 days +/- 91.4 and 143.0 days +/- 26.7, respectively. The use of a retrievable metallic stent internally coated with silicone is a safe and effective method for relieving dyspnea, with adequate stent patency in patients with benign or malignant central airway obstructions. This stent design seems to be less prone to migration or mucous retention.

A Critical Review on Metallic Glasses as Structural Materials for Cardiovascular Stent Applications.

PubMed

Jafary-Zadeh, Mehdi; Praveen Kumar, Gideon; Branicio, Paulo Sergio; Seifi, Mohsen; Lewandowski, John J; Cui, Fangsen

2018-02-27

Functional and mechanical properties of novel biomaterials must be carefully evaluated to guarantee long-term biocompatibility and structural integrity of implantable medical devices. Owing to the combination of metallic bonding and amorphous structure, metallic glasses (MGs) exhibit extraordinary properties superior to conventional crystalline metallic alloys, placing them at the frontier of biomaterials research. MGs have potential to improve corrosion resistance, biocompatibility, strength, and longevity of biomedical implants, and hence are promising materials for cardiovascular stent applications. Nevertheless, while functional properties and biocompatibility of MGs have been widely investigated and validated, a solid understanding of their mechanical performance during different stages in stent applications is still scarce. In this review, we provide a brief, yet comprehensive account on the general aspects of MGs regarding their formation, processing, structure, mechanical, and chemical properties. More specifically, we focus on the additive manufacturing (AM) of MGs, their outstanding high strength and resilience, and their fatigue properties. The interconnection between processing, structure and mechanical behaviour of MGs is highlighted. We further review the main categories of cardiovascular stents, the required mechanical properties of each category, and the conventional materials have been using to address these requirements. Then, we bridge between the mechanical requirements of stents, structural properties of MGs, and the corresponding stent design caveats. In particular, we discuss our recent findings on the feasibility of using MGs in self-expandable stents where our results show that a metallic glass based aortic stent can be crimped without mechanical failure. We further justify the safe deployment of this stent in human descending aorta. It is our intent with this review to inspire biodevice developers toward the realization of MG-based stents.

A Critical Review on Metallic Glasses as Structural Materials for Cardiovascular Stent Applications

PubMed Central

Jafary-Zadeh, Mehdi; Praveen Kumar, Gideon

2018-01-01

Functional and mechanical properties of novel biomaterials must be carefully evaluated to guarantee long-term biocompatibility and structural integrity of implantable medical devices. Owing to the combination of metallic bonding and amorphous structure, metallic glasses (MGs) exhibit extraordinary properties superior to conventional crystalline metallic alloys, placing them at the frontier of biomaterials research. MGs have potential to improve corrosion resistance, biocompatibility, strength, and longevity of biomedical implants, and hence are promising materials for cardiovascular stent applications. Nevertheless, while functional properties and biocompatibility of MGs have been widely investigated and validated, a solid understanding of their mechanical performance during different stages in stent applications is still scarce. In this review, we provide a brief, yet comprehensive account on the general aspects of MGs regarding their formation, processing, structure, mechanical, and chemical properties. More specifically, we focus on the additive manufacturing (AM) of MGs, their outstanding high strength and resilience, and their fatigue properties. The interconnection between processing, structure and mechanical behaviour of MGs is highlighted. We further review the main categories of cardiovascular stents, the required mechanical properties of each category, and the conventional materials have been using to address these requirements. Then, we bridge between the mechanical requirements of stents, structural properties of MGs, and the corresponding stent design caveats. In particular, we discuss our recent findings on the feasibility of using MGs in self-expandable stents where our results show that a metallic glass based aortic stent can be crimped without mechanical failure. We further justify the safe deployment of this stent in human descending aorta. It is our intent with this review to inspire biodevice developers toward the realization of MG-based stents

Esophagojejunal Anastomosis Fistula, Distal Esophageal Stenosis, and Metalic Stent Migration after Total Gastrectomy

PubMed Central

Al Hajjar, Nadim; Popa, Calin; Al-Momani, Tareg; Margarit, Simona; Graur, Florin; Tantau, Marcel

2015-01-01

Esophagojejunal anastomosis fistula is the main complication after a total gastrectomy. To avoid a complex procedure on friable inflamed perianastomotic tissues, a coated self-expandable stent is mounted at the site of the anastomotic leak. A complication of stenting procedure is that it might lead to distal esophageal stenosis. However, another frequently encountered complication of stenting is stent migration, which is treated nonsurgically. When the migrated stent creates life threatening complications, surgical removal is indicated. We present a case of a 67-year-old male patient who was treated at our facility for a gastric adenocarcinoma which developed, postoperatively, an esophagojejunostomy fistula, a distal esophageal stenosis, and a metallic coated self-expandable stent migration. To our knowledge, this is the first reported case of an esophagojejunostomy fistula combined with a distal esophageal stenosis as well as with a metallic coated self-expandable stent migration. PMID:25945277

Difficult removal of fully covered self expandable metal stents (SEMS) for benign biliary strictures: the "SEMS in SEMS" technique.

PubMed

Tringali, Andrea; Blero, Daniel; Boškoski, Ivo; Familiari, Pietro; Perri, Vincenzo; Devière, Jacques; Costamagna, Guido

2014-06-01

Removal of biliary Fully Covered Self Expandable Metal Stents can fail due to stent migration and/or hyperplastic ingrowth/overgrowth. A case series of 5 patients with benign biliary strictures (2 post-cholecystectomy, 2 following liver transplantation and 1 related to chronic pancreatitis) is reported. The biliary stricture was treated by temporary insertion of Fully Covered Self Expandable Metal Stents. Stent removal failed due to proximal stent migration and/or overgrowth. Metal stent removal was attempted a few weeks after the insertion of another Fully Covered Metal Stent into the first one. The inner Fully Covered Self Expandable Metal Stent compressed the hyperplastic tissue, leading to the extraction of both the stents in all cases. Two complications were reported as a result of the attempt to stents removal (mild pancreatitis and self-limited haemobilia). In the present series, the "SEMS in SEMS" technique revealed to be effective when difficulties are encountered during Fully Covered Self Expandable Metal Stents removal. Copyright © 2014 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

Side-by-side placement of bilateral endoscopic metal stents for the treatment of postoperative biliary stricture.

PubMed

Kaino, Seiji; Sen-Yo, Manabu; Shinoda, Shuhei; Kawano, Michitaka; Harima, Hirofumi; Suenaga, Shigeyuki; Sakaida, Isao

2017-02-01

Postoperative biliary strictures are usually complications of cholecystectomy. Endoscopic plastic stent prosthesis is generally undertaken for treating benign biliary strictures. Recently, fully covered metal stents have been shown to be effective for treating benign distal biliary strictures. We present the case of a 53-year-old woman with liver injury in which imaging studies showed a common hepatic duct stricture. Endoscopic retrograde cholangiopancreatography also confirmed the presence of a common hepatic duct stricture. Temporally fully covered metal stents with dilated diameters of 6 mm were placed in a side-by-side fashion in the left and right hepatic ducts, respectively. We removed the stents 2 months after their placement. Subsequent cholangiography revealed an improvement in the biliary strictures. Although we were apprehensive about the fully covered metal stents obstructing the biliary side branches, we noted that careful placement of the bilateral metal stents did not cause any complications. Side-by-side deployment of bilateral endoscopic fully covered metal stents can be one of the safe and effective therapies for postoperative biliary stricture.

Outcomes of secondary self-expandable metal stents versus surgery after delayed initial palliative stent failure in malignant colorectal obstruction.

PubMed

Yoon, Jin Young; Park, Soo Jung; Hong, Sung Pil; Kim, Tae Il; Kim, Won Ho; Cheon, Jae Hee

2013-01-01

When re-intervention is required due to an occluded first colorectal self-expanding metal stent for malignant colorectal obstruction, serious controversies exist regarding whether to use endoscopic re-stenting or surgery. To compare the clinical outcomes in patients who underwent stent re-insertion versus palliative surgery as a second intervention. A total of 115 patients who received either self-expandable metal stent (SEMS) insertion or palliative surgery for treatment of a second occurrence of malignant colorectal obstruction after the first SEMS placement were retrospectively studied between July 2005 and December 2009. The median overall survival (8.2 vs. 15.5 months) and progression-free survival (4.0 vs. 2.7 months) were not significantly different between the stent and surgery groups (p = 0.895 and 0.650, respectively). The median lumen patency in the stent group was 3.4 months and that in the surgery group was 7.9 months (p = 0.003). The immediate complication rate after second stent insertion was 13.9% and late complication rate was observed in 12 of 79 (15.2%) patients. There was no mortality related to the SEMS procedure. The complication and mortality rates associated with palliative surgery were 3.5% (2/57) and 12.3% (7/57), respectively. Although there is no significant difference in the overall survival between stenting and surgery, a secondary stent insertion had a lower mortality rate despite a shorter duration of temporary colorectal decompression compared to that of palliative surgery.

Metallic stents in the management of ureteric strictures

PubMed Central

Kulkarni, Ravi

2014-01-01

Management of ureteric strictures is a challenging task. Subtle presentation, silent progression and complex aetiology may delay diagnosis. A wide range of available treatment options combined with the lack of adequate randomised trials has led to the introduction of personal bias in the management of this difficult group of patients. Metallic ureteric stents offer an alternative to the conventional treatment modalities. A review of the currently available metallic stents and their role in the long-term management of ureteric strictures is presented. Materials used in the manufacture of indwelling urological devices are evolving all the time. Improved endo-urological techniques combined with new devices made from better compounds will continue to improve patient experience. PMID:24497686

A shape memory airway stent for tracheobronchomalacia in children: an experimental and clinical study.

PubMed

Tsugawa, C; Nishijima, E; Muraji, T; Yoshimura, M; Tsubota, N; Asano, H

1997-01-01

The authors have designed a coil airway stent using a thermal shape-memory titanium-nickel alloy (SMA) to relieve airway collapse in children. A characteristic of alloy allowed the stent to be enclosed in the thin introducer tube and to position it bronchoscopically in the collapsed airway. When the stent is warmed to 37 to 40 degrees C, it expands to the memorized diameter and stents the airway. In eight rabbits, an experimental model of potentially fatal tracheomalacia was created by fracturing the tracheal cartilages. The stents of 6 mm in diameter and 15 mm in length were placed, and then the stents were recovered to their original shape within 1 minute. All rabbits except one showed no respiratory symptoms during the follow-up period. Results of bronchoscopy performed 6 and 10 months after implantation showed satisfactory patency of the trachea. The rabbits were killed for histological evaluation 6 to 28 months after implantation. The specimens showed little proliferation of granulation and no dislodgement of the stents. This procedure was attempted in two children who had severe bronchomalacia. One 5-year-old patient underwent implantation with a stent of 5 mm in diameter and 25 mm in length into the left main bronchus. The patient was relieved from apneic attacks. The stent was removed 2 years after implantation after a remarkable improvement of ventilation. The other patient with left bronchomalacia, age 1 year 2 months, underwent implantation with a 5-mm x 20-mm stent. The animal experiment and clinical experience indicated that (1) this stent can be easily inserted and removed bronchoscopically, (2) the stent has good tissue compatibility and little interference of mucociliary function, and (3) the SMA stent is a promising therapeutic adjunct in the management of children with severe tracheobronchomalacia.

Comparison of a New Polytetrafluoroethylene-Covered Metallic Stent to a Noncovered Stent in Canine Ureters

DOE Office of Scientific and Technical Information (OSTI.GOV)

Chung, Hwan-Hoon, E-mail: chungmic@korea.ac.kr; Lee, Seung Hwa; Cho, Sung Bum

The aim of this study was to determine the feasibility of using a newly designed polytetrafluoroethylene (PTFE)-covered metallic stent in the ureter by comparing its effectiveness with that of the noncovered stent in a canine model. We placed 14 stents in the ureters of seven mongrel dogs that weighed 30-40 kg each. The covered and noncovered stents were deployed in the right and left ureters, respectively, of six dogs. In the seventh dog, a covered stent and a double-J catheter were inserted in the right ureter, and a covered stent only was inserted in the left ureter. The first sixmore » dogs were sacrificed at 5, 10, and 15 weeks after deployment of the stents (two for each follow-up period), and the seventh dog was sacrificed at 30 weeks. There was no migration or poor expansion of any of the stents observed on plain radiography. On intravenous pyelogram and retrograde pyelogram, all of the covered stents at each follow-up period had patent lumens at the stented segments without hydronephrosis, and the passage of contrast material through it was well preserved. The noncovered stents in the dogs sacrificed at 5 and 10 weeks and one of the two dogs sacrificed at 15 weeks showed near-complete occlusion of the stent lumen due to ingrowth of the soft tissue, and severe hydronephrosis was also noted. The noncovered stent in the other dog sacrificed at 15 weeks showed the passage of contrast material without hydronephrosis, but the lumen of the stent was still nearly occluded by the soft tissue. There was no evidence of hydronephrosis or passage disturbance of the contrast material in both ureters of the dog sacrificed at 30 weeks. We conclude that the newly designed PTFE-covered stent effectively prevented the luminal occlusion caused by urothelial hyperplasia compared to the near-total occlusion of the noncovered stents, and no migration of the covered stents was noted.« less

Partially Covered Metal Stents May Not Prolong Stent Patency Compared to Uncovered Stents in Unresectable Malignant Distal Biliary Obstruction.

PubMed

Kim, Jae Yun; Ko, Gyu Bong; Lee, Tae Hoon; Park, Sang-Heum; Lee, Yun Nah; Cho, Young Sin; Jung, Yunho; Chung, Il-Kwun; Choi, Hyun Jong; Cha, Sang-Woo; Moon, Jong Ho; Cho, Young Deok; Kim, Sun-Joo

2017-05-15

Controversy still exists regarding the benefits of covered self-expandable metal stents (SEMSs) compared to uncovered SEMSs. We aimed to compare the patency and stent-related adverse events of partially covered SEMSs (PC-SEMSs) and uncovered SEMSs in unresectable malignant distal biliary obstruction. A total of 134 patients who received a PC-SEMS or uncovered SEMS for palliation of unresectable malignant distal biliary obstruction were reviewed retrospectively. The main outcome measures were stent patency, stent-related adverse events, and overall survival. The median stent patency was 118 days (range, 3 to 802 days) with PC-SEMSs and 105 days (range, 2 to 485 days) with uncovered SEMSs (p=0.718). The overall endoscopic revision rate due to stent dysfunction was 36.6% (26/71) with PC-SEMSs and 36.5% (23/63) with uncovered SEMSs (p=0.589). Tumor ingrowth was more frequent with uncovered SEMSs (4.2% vs 19.1%, p=0.013), but migration was more frequent with PC-SEMSs (11.2% vs 1.5%, p=0.04). The incidence of stent-related adverse events was 2.8% (2/71) with PC-SEMSs and 9.5% (6/63) with uncovered SEMSs (p=0.224). The median overall survival was 166 days with PC-SEMSs and 168 days with uncovered SEMSs (p=0.189). Compared to uncovered SEMSs, PC-SEMSs did not prolong stent patency in unresectable malignant distal biliary obstruction. Stent migration was more frequent with PC-SEMSs. However, tumor ingrowth was less frequent with PC-SEMSs compared to uncovered SEMSs.

Partially Covered Metal Stents May Not Prolong Stent Patency Compared to Uncovered Stents in Unresectable Malignant Distal Biliary Obstruction

PubMed Central

Kim, Jae Yun; Ko, Gyu Bong; Lee, Tae Hoon; Park, Sang-Heum; Lee, Yun Nah; Cho, Young Sin; Jung, Yunho; Chung, Il-Kwun; Choi, Hyun Jong; Cha, Sang-Woo; Moon, Jong Ho; Cho, Young Deok; Kim, Sun-Joo

2017-01-01

Background/Aims Controversy still exists regarding the benefits of covered self-expandable metal stents (SEMSs) compared to uncovered SEMSs. We aimed to compare the patency and stent-related adverse events of partially covered SEMSs (PC-SEMSs) and uncovered SEMSs in unresectable malignant distal biliary obstruction. Methods A total of 134 patients who received a PC-SEMS or uncovered SEMS for palliation of unresectable malignant distal biliary obstruction were reviewed retrospectively. The main outcome measures were stent patency, stent-related adverse events, and overall survival. Results The median stent patency was 118 days (range, 3 to 802 days) with PC-SEMSs and 105 days (range, 2 to 485 days) with uncovered SEMSs (p=0.718). The overall endoscopic revision rate due to stent dysfunction was 36.6% (26/71) with PC-SEMSs and 36.5% (23/63) with uncovered SEMSs (p=0.589). Tumor ingrowth was more frequent with uncovered SEMSs (4.2% vs 19.1%, p=0.013), but migration was more frequent with PC-SEMSs (11.2% vs 1.5%, p=0.04). The incidence of stent-related adverse events was 2.8% (2/71) with PC-SEMSs and 9.5% (6/63) with uncovered SEMSs (p=0.224). The median overall survival was 166 days with PC-SEMSs and 168 days with uncovered SEMSs (p=0.189). Conclusions Compared to uncovered SEMSs, PC-SEMSs did not prolong stent patency in unresectable malignant distal biliary obstruction. Stent migration was more frequent with PC-SEMSs. However, tumor ingrowth was less frequent with PC-SEMSs compared to uncovered SEMSs. PMID:28208003

Anesthesia and airway management for removing pulmonary self-expanding metallic stents.

PubMed

Doyle, D John; Abdelmalak, Basem; Machuzak, Michael; Gildea, Thomas R

2009-11-01

The use of bronchoscopically placed self-expanding metallic stents (SEMS) and silastic stents in patients suffering from tracheobronchial stenosis or similar problems has proven to be an important clinical option. When complications occur, it may be necessary to remove the device. Removal of a SEMS is usually performed during general anesthesia with muscle relaxation and positive pressure ventilation, often using total intravenous anesthesia. Airway management depends on stent type and location. Intubating patients' tracheas with a tracheal stent requires special caution, as it risks damaging tissue and dislodging the stent distally. Potential complications with removal include tracheal disruption, retained stent pieces, mucosal tears, re-obstruction requiring new stent placement, the need for postoperative ventilation, pneumothorax, damage to the pulmonary artery, and death.

The Influence of a Metal Stent on the Distribution of Thermal Energy during Irreversible Electroporation

PubMed Central

van den Bos, Willemien; Neal, Robert E.; van Lienden, Krijn P.; Besselink, Marc G. H.; van Gemert, Martin J. C.; van der Geld, Cees W. M.; Meijerink, Martijn R.; Klaessens, John H.; Verdaasdonk, Rudolf M.

2016-01-01

Purpose Irreversible electroporation (IRE) uses short duration, high-voltage electrical pulses to induce cell death via nanoscale defects resulting from altered transmembrane potential. The technique is gaining interest for ablations in unresectable pancreatic and hepatobiliary cancer. Metal stents are often used for palliative biliary drainage in these patients, but are currently seen as an absolute contraindication for IRE due to the perceived risk of direct heating of the metal and its surroundings. This study investigates the thermal and tissue viability changes due to a metal stent during IRE. Methods IRE was performed in a homogeneous tissue model (polyacrylamide gel), without and with a metal stent placed perpendicular and parallel to the electrodes, delivering 90 and 270 pulses (15–35 A, 90 μsec, 1.5 cm active tip exposure, 1.5 cm interelectrode distance, 1000–1500 V/cm, 90 pulses/min), and in-vivo in a porcine liver (4 ablations). Temperature changes were measured with an infrared thermal camera and with fiber-optic probes. Tissue viability after in-vivo IRE was investigated macroscopically using 5-triphenyltetrazolium chloride (TTC) vitality staining. Results In the gel, direct stent-heating was not observed. Contrarily, the presence of a stent between the electrodes caused a higher increase in median temperature near the electrodes (23.2 vs 13.3°C [90 pulses]; p = 0.021, and 33.1 vs 24.8°C [270 pulses]; p = 0.242). In-vivo, no temperature difference was observed for ablations with and without a stent. Tissue examination showed white coagulation 1mm around the electrodes only. A rim of vital tissue remained around the stent, whereas ablation without stent resulted in complete tissue avitality. Conclusion IRE in the vicinity of a metal stent does not cause notable direct heating of the metal, but results in higher temperatures around the electrodes and remnant viable tissue. Future studies should determine for which clinical indications IRE in the

Temporary placement of metallic stent could lead to long-term benefits for benign tracheobronchial stenosis.

PubMed

Zhou, Guo-Wu; Huang, Hai-Dong; Sun, Qin-Ying; Xiong, Ye; Li, Qiang; Dong, Yu-Chao; Zhang, Wei

2015-12-01

The permanent placement of metallic stent for benign tracheobronchial stenosis (BTS) was controversial. This study was conducted to evaluate the long-term outcomes of temporary placement of metallic stent for BTS. The BTS patients who received temporary placement of retrievable self-expanded metallic stents were included between 2008 and 2011. Pre-stenting and follow-up respiratory status was analyzed. And symptom recurrence-free survival (SRFS) was assessed. A total of 49 stents were successfully temporarily placed in 40 consecutive BTS patients whose etiologies included endobronchial tuberculosis (EBTB) (n=22), post-tracheostomy stenosis (n=10), post-intubation stenosis (n=6) and post radiotherapy stricture (n=2). All stents were removed integrally after a median 18 days' stenting period, without major complications. During the median 27 months follow-up period after stent removal, a total of 22 patients were free of recurrence. And the overall 3-year SRFS rate was 52.0%. According to the etiology, the 3-year SRFS rates were 59.1% and 42.9% in the patients with EBTB and non-EBTB, respectively. Compared with pre-stenting, the follow-up internal diameter of stricture, Hugh-Jones scale, 6-minute walk test (6MWT) and percentage of forced expiratory volume in one second (FEV1%) were significantly improved. Multivariate analysis suggested that granulation tissue growth and tracheobronchial malacia might be independent factors of poor prognosis. Temporary placement of retrievable metallic stent may be an alternative treatment for BTS patients.

Fully-covered metal stents with endoscopic suturing vs. partially-covered metal stents for benign upper gastrointestinal diseases: a comparative study

PubMed Central

Ngamruengphong, Saowanee; Sharaiha, Reem; Sethi, Amrita; Siddiqui, Ali; DiMaio, Christopher J.; Gonzalez, Susana; Rogart, Jason; Jagroop, Sophia; Widmer, Jessica; Im, Jennifer; Hasan, Raza Abbas; Laique, Sobia; Gonda, Tamas; Poneros, John; Desai, Amit; Wong, Katherine; Villgran, Vipin; Brewer Gutierrez, Olaya; Bukhari, Majidah; Chen, Yen-I; Hernaez, Ruben; Hanada, Yuri; Sanaei, Omid; Agarwal, Amol; Kalloo, Anthony N.; Kumbhari, Vivek; Singh, Vikesh; Khashab, Mouen A.

2018-01-01

Background and study aims  Self-expandable metallic stents (SEMS) have been increasingly used in benign conditions (e. g. strictures, fistulas, leaks, and perforations). Fully covered SEMS (FSEMS) were introduced to avoid undesirable consequences of partially covered SEMS (PSEMS), but come with higher risk of stent migration. Endoscopic suturing (ES) for stent fixation has been shown to reduce migration of FSEMS. Our aim was to compare the outcomes of FSEMS with ES (FS/ES) versus PSEMS in patients with benign upper gastrointestinal conditions. Patients and methods  We retrospectively identified all patients who underwent stent placement for benign gastrointestinal conditions at seven US tertiary-care centers. Patients were divided into two groups: FSEMS with ES (FS/ES group) and PSEMS (PSEMS group). Clinical outcomes between the two groups were compared. Results  A total of 74 (FS/ES 46, PSEMS 28) patients were included. On multivariable analysis, there was no significant difference in rate of stent migration between FS/ES (43 %) and PSEMS (15 %) (adjusted odds ratio 0.56; 95 % CI 0.15 – 2.00). Clinical success was similar [68 % vs. 64 %; P  = 0.81]. Rate of adverse events (AEs) was higher in PSEMS group [13 (46 %) vs. 10 (21 %); P  = 0.03). Difficult stent removal was higher in the PSEMS group (n = 5;17 %) vs. 0 % in the FS/ES group; P  = 0.005. Conclusions  The proportion of stent migration of FS/ES and PSEMS are similar. Rates of other stent-related AEs were higher in the PSEMS group. PSEMS was associated with tissue ingrowth or overgrowth leading to difficult stent removal, and secondary stricture formation. Thus, FSEMS with ES for stent fixation may be the preferred modality over PSEMS for the treatment of benign upper gastrointestinal conditions. PMID:29404384

The use of cold sprayed alloys for metallic stents

NASA Astrophysics Data System (ADS)

AL-Mangour, Bandar

With the invention of the coronary stent, which is a wire metal mesh tube designed to keep the arteries open in the treatment of heart diseases, promising clinical outcomes were generated. However, the long term successes of stents have been delayed by significant in-stent restenosis (blockages) and stent fracture. In this research work, it has been proposed to use Cold Gas Dynamic Spraying (CGDS) coating material as an alternative choice to manufacture metallic stent. In CGDS, fine particles are accelerated to a high velocity and undergo solid-state plastic deformation upon impact on the substrate, which leads to particle-particle bonding. The feature of CGDS distinct from other thermal spray techniques is that the processing gas temperature is below the melting point of the feedstock. Therefore, unwanted effects of high temperatures, such as oxidation, grain growth and thermal stresses, are absent. In response to the fact that the majority of stents are made from stainless steel (316L) or Co-Cr alloy (L605), this study specifically addresses the development and characterization of 316L and 316L mixed with L605 coatings produced by the CGDS process. Scanning electron microscopy and electron backscatter diffraction were used to investigate the microstructural changes of these coatings before and after annealing. The effect of gas type on the microstructure of 316L coatings and the role of post-heat treatment in the microstructure and properties are also studied. Of particular interest are grain refinement, heat treatment, mechanical properties and corrosion behavior of the cold sprayed material.

Effect of Covered Metallic Stents Compared With Plastic Stents on Benign Biliary Stricture Resolution: A Randomized Clinical Trial.

PubMed

Coté, Gregory A; Slivka, Adam; Tarnasky, Paul; Mullady, Daniel K; Elmunzer, B Joseph; Elta, Grace; Fogel, Evan; Lehman, Glen; McHenry, Lee; Romagnuolo, Joseph; Menon, Shyam; Siddiqui, Uzma D; Watkins, James; Lynch, Sheryl; Denski, Cheryl; Xu, Huiping; Sherman, Stuart

Endoscopic placement of multiple plastic stents in parallel is the first-line treatment for most benign biliary strictures; it is possible that fully covered, self-expandable metallic stents (cSEMS) may require fewer endoscopic retrograde cholangiopancreatography procedures (ERCPs) to achieve resolution. To assess whether use of cSEMS is noninferior to plastic stents with respect to stricture resolution. Multicenter (8 endoscopic referral centers), open-label, parallel, randomized clinical trial involving patients with treatment-naive, benign biliary strictures (N = 112) due to orthotopic liver transplant (n = 73), chronic pancreatitis (n = 35), or postoperative injury (n = 4), who were enrolled between April 2011 and September 2014 (with follow-up ending October 2015). Patients with a bile duct diameter less than 6 mm and those with an intact gallbladder in whom the cystic duct would be overlapped by a cSEMS were excluded. Patients (N = 112) were randomized to receive multiple plastic stents or a single cSEMS, stratified by stricture etiology and with endoscopic reassessment for resolution every 3 months (plastic stents) or every 6 months (cSEMS). Patients were followed up for 12 months after stricture resolution to assess for recurrence. Primary outcome was stricture resolution after no more than 12 months of endoscopic therapy. The sample size was estimated based on the noninferiority of cSEMS to plastic stents, with a noninferiority margin of -15%. There were 55 patients in the plastic stent group (mean [SD] age, 57 [11] years; 17 women [31%]) and 57 patients in the cSEMS group (mean [SD] age, 55 [10] years; 19 women [33%]). Compared with plastic stents (41/48, 85.4%), the cSEMS resolution rate was 50 of 54 patients (92.6%), with a rate difference of 7.2% (1-sided 95% CI, -3.0% to ∞; P < .001). Given the prespecified noninferiority margin of -15%, the null hypothesis that cSEMS is less effective than plastic stents was rejected. The

Efficacy of Retrievable Metallic Stent with Fixation String for Benign Stricture after Upper Gastrointestinal Surgery.

PubMed

Kim, Jeong-Eun; Kim, Hyo-Cheol; Lee, Myungsu; Hur, Saebeom; Kim, Minuk; Lee, Sang Hwan; Cho, Soo Buem; Kim, Chan Sun; Han, Joon Koo

2016-01-01

To determine the efficacy of retrievable metallic stent with fixation string for benign anastomotic stricture after upper gastrointestinal (UGI) surgery. From June 2009 to May 2015, a total of 56 retrievable metallic stents with fixation string were placed under fluoroscopy guidance in 42 patients who were diagnosed with benign anastomotic stricture after UGI surgery. Clinical success was defined as achieving normal regular diet (NRD). The clinical success rate after the first stent placement was 57.1% (24/42). After repeated stent placement and/or balloon dilation, the clinical success rate was increased to 83.3% (35/42). Six (14.3%) patients required surgical revision to achieve NRD. One (2.4%) patient failed to achieve NRD. Stent migration occurred in 60.7% (34/56) of patients. Successful rate of removing the stent using fixation string and angiocatheter was 94.6% (53/56). Distal migration occurred in 12 stents. Of the 12 stents, 10 (83.3%) were successfully removed whereas 2 could not be removed. No complication occurred regarding distal migration. Using retrievable metallic stent with a fixation string is a feasible option for managing early benign anastomotic stricture after UGI surgery. It can reduce complications caused by distal migration of the stent.

Efficacy of Retrievable Metallic Stent with Fixation String for Benign Stricture after Upper Gastrointestinal Surgery

PubMed Central

Kim, Jeong-Eun; Lee, Myungsu; Hur, Saebeom; Kim, Minuk; Lee, Sang Hwan; Cho, Soo Buem; Kim, Chan Sun; Han, Joon Koo

2016-01-01

Objective To determine the efficacy of retrievable metallic stent with fixation string for benign anastomotic stricture after upper gastrointestinal (UGI) surgery. Materials and Methods From June 2009 to May 2015, a total of 56 retrievable metallic stents with fixation string were placed under fluoroscopy guidance in 42 patients who were diagnosed with benign anastomotic stricture after UGI surgery. Clinical success was defined as achieving normal regular diet (NRD). Results The clinical success rate after the first stent placement was 57.1% (24/42). After repeated stent placement and/or balloon dilation, the clinical success rate was increased to 83.3% (35/42). Six (14.3%) patients required surgical revision to achieve NRD. One (2.4%) patient failed to achieve NRD. Stent migration occurred in 60.7% (34/56) of patients. Successful rate of removing the stent using fixation string and angiocatheter was 94.6% (53/56). Distal migration occurred in 12 stents. Of the 12 stents, 10 (83.3%) were successfully removed whereas 2 could not be removed. No complication occurred regarding distal migration. Conclusion Using retrievable metallic stent with a fixation string is a feasible option for managing early benign anastomotic stricture after UGI surgery. It can reduce complications caused by distal migration of the stent. PMID:27833405

Predictors of the patency of self-expandable metallic stents in malignant gastroduodenal obstruction.

PubMed

Kim, Seung Han; Chun, Hoon Jai; Yoo, In Kyung; Lee, Jae Min; Nam, Seung Joo; Choi, Hyuk Soon; Kim, Eun Sun; Keum, Bora; Seo, Yeon Seok; Jeen, Yoon Tae; Lee, Hong Sik; Um, Soon Ho; Kim, Chang Duck

2015-08-14

To investigate the predictive factors of self-expandable metallic stent patency after stent placement in patients with inoperable malignant gastroduodenal obstruction. A total of 116 patients underwent stent placements for inoperable malignant gastroduodenal obstruction at a tertiary academic center. Clinical success was defined as acceptable decompression of the obstructive lesion within the malignant gastroduodenal neoplasm. We evaluated patient comorbidities and clinical statuses using the World Health Organization's scoring system and categorized patient responses to chemotherapy using the Response Evaluation Criteria in Solid Tumors criteria. We analyzed the relationships between possible predictive factors and stent patency. Self-expandable metallic stent placement was technically successful in all patients (100%), and the clinical success rate was 84.2%. In a multivariate Cox proportional hazards model, carcinoembryonic antigen (CEA) levels were correlated with a reduction in stent patency [P = 0.006; adjusted hazard ratio (aHR) = 2.92, 95%CI: 1.36-6.25]. Palliative chemotherapy was statistically associated with an increase in stent patency (P = 0.009; aHR = 0.27, 95%CI: 0.10-0.72). CEA levels can easily be measured at the time of stent placement and may help clinicians to predict stent patency and determine the appropriate stent procedure.

Predictors of the patency of self-expandable metallic stents in malignant gastroduodenal obstruction

PubMed Central

Kim, Seung Han; Chun, Hoon Jai; Yoo, In Kyung; Lee, Jae Min; Nam, Seung Joo; Choi, Hyuk Soon; Kim, Eun Sun; Keum, Bora; Seo, Yeon Seok; Jeen, Yoon Tae; Lee, Hong Sik; Um, Soon Ho; Kim, Chang Duck

2015-01-01

AIM: To investigate the predictive factors of self-expandable metallic stent patency after stent placement in patients with inoperable malignant gastroduodenal obstruction. METHODS: A total of 116 patients underwent stent placements for inoperable malignant gastroduodenal obstruction at a tertiary academic center. Clinical success was defined as acceptable decompression of the obstructive lesion within the malignant gastroduodenal neoplasm. We evaluated patient comorbidities and clinical statuses using the World Health Organization’s scoring system and categorized patient responses to chemotherapy using the Response Evaluation Criteria in Solid Tumors criteria. We analyzed the relationships between possible predictive factors and stent patency. RESULTS: Self-expandable metallic stent placement was technically successful in all patients (100%), and the clinical success rate was 84.2%. In a multivariate Cox proportional hazards model, carcinoembryonic antigen (CEA) levels were correlated with a reduction in stent patency [P = 0.006; adjusted hazard ratio (aHR) = 2.92, 95%CI: 1.36-6.25]. Palliative chemotherapy was statistically associated with an increase in stent patency (P = 0.009; aHR = 0.27, 95%CI: 0.10-0.72). CONCLUSION: CEA levels can easily be measured at the time of stent placement and may help clinicians to predict stent patency and determine the appropriate stent procedure. PMID:26290640

Silicone tracheobronchial stent: A rare cause for bronchoesophageal fistula and distortion of airway anatomy.

PubMed

Kumar, Bhupesh; Munirathinam, Ganesh Kumar; Puri, Goverdhan Dutt; Mishra, Anand Kumar; Arya, Virendra Kumar

2017-01-01

Silicone tracheobronchial stents are being increasingly used in a large number of patients for the treatment of tracheal stenosis. One very rare complication due to tracheobronchial stenting is bronchoesophageal fistula (BEF), which has been associated with the use of metallic stents. We report intraoperative management of a patient undergoing repair of a BEF, following previous insertion of a silicone Y-stent that is soft in texture and has not been implicated for this complication till date. In addition, misalignment of this silicone tracheobronchial Y-stent resulted in a tracheal mucosal bulge proximal to the stent that vanished after its removal.

Silicone Tracheobronchial Stent: A Rare Cause for Bronchoesophageal Fistula and Distortion of Airway Anatomy

PubMed Central

Kumar, Bhupesh; Munirathinam, Ganesh Kumar; Puri, Goverdhan Dutt; Mishra, Anand Kumar; Arya, Virendra Kumar

2017-01-01

Silicone tracheobronchial stents are being increasingly used in a large number of patients for the treatment of tracheal stenosis. One very rare complication due to tracheobronchial stenting is bronchoesophageal fistula (BEF), which has been associated with the use of metallic stents. We report intraoperative management of a patient undergoing repair of a BEF, following previous insertion of a silicone Y-stent that is soft in texture and has not been implicated for this complication till date. In addition, misalignment of this silicone tracheobronchial Y-stent resulted in a tracheal mucosal bulge proximal to the stent that vanished after its removal. PMID:28701606

[Treatment of tracheobronchomalacia with expandable metallic stents].

PubMed

Antón-Pacheco Sánchez, J; García Vázquez, A; Cuadros García, J; Cano Novillo, I; Villafruela Sanz, M; Berchi García, F J

2002-10-01

Tracheomalacia is an unfrequent disease that causes tracheal collapse during breathing. It is generally associated to esophageal atresia, but cases of primary tracheomalacia and others secondary to extrinsic compression, have also been described. Spontaneous resolution is generally the rule and only a few cases need surgical treatment. When this therapy fails or is not indicated for any reason, endoluminal tracheobronchial stents may be used. We have treated two patients with four expandable metallic stents: one had severe tracheomalacia associated to esophageal atresia and the other tracheobronchomalacia secondary to cardiomegaly. Results have been good in both cases.

Mechanisms and Patterns of Intravascular Ultrasound In-Stent Restenosis Among Bare Metal Stents and First- and Second-Generation Drug-Eluting Stents.

PubMed

Goto, Kosaku; Zhao, Zhijing; Matsumura, Mitsuaki; Dohi, Tomotaka; Kobayashi, Nobuaki; Kirtane, Ajay J; Rabbani, LeRoy E; Collins, Michael B; Parikh, Manish A; Kodali, Susheel K; Leon, Martin B; Moses, Jeffrey W; Mintz, Gary S; Maehara, Akiko

2015-11-01

The most common causes of in-stent restenosis (ISR) are intimal hyperplasia and stent under expansion. The purpose of this study was to use intravascular ultrasound (IVUS) to compare the ISR mechanisms of bare metal stents (BMS), first-generation drug-eluting stents (DES), and second-generation DES. There were 298 ISR lesions including 52 BMS, 73 sirolimus-eluting stents, 52 paclitaxel-eluting stents, 16 zotarolimus-eluting stents, and 105 everolimus-eluting stent. Mean patient age was 66.6 ± 1.1 years, 74.2% were men, and 48.3% had diabetes mellitus. BMS restenosis presented later (70.0 ± 66.7 months) with more intimal hyperplasia compared with DES (BMS 58.6 ± 15.5%, first-generation DES 52.6 ± 20.9%, second-generation DES 48.2 ± 22.2%, p = 0.02). Although reference lumen areas were similar in BMS and first- and second-generation DES, restenotic DES were longer (BMS 21.8 ± 13.5 mm, first-generation DES 29.4 ± 16.1 mm, second-generation DES 32.1 ± 18.7 mm, p = 0.003), and stent areas were smaller (BMS 7.2 ± 2.4 mm(2), first-generation DES 6.1 ± 2.1 mm(2), second-generation DES 5.7 ± 2.0 mm(2), p <0.001). Stent fracture was seen only in DES (first-generation DES 7 [5.0%], second-generation DES 8 [7.4%], p = 0.13). In conclusion, restenotic first- and second-generation DES were characterized by less neointimal hyperplasia, smaller stent areas, longer stent lengths, and more stent fractures than restenotic BMS. Copyright © 2015 Elsevier Inc. All rights reserved.

A novel endobronchial approach to massive hemoptysis complicating silicone Y-stent placement for tracheobronchomalacia

PubMed Central

Ryu, Changwan; Boffa, Daniel; Bramley, Kyle; Pisani, Margaret; Puchalski, Jonathan

2018-01-01

Abstract Rationale: Airway stabilization for severe, symptomatic tracheobronchomalacia (TBM) may be accomplished by silicone Y-stent placement. Common complications of the Y-stent include mucus plugging and granulation tissue formation. Patient concerns: We describe a rare case of massive hemoptysis originating from a silicone Y-stent placed for TBM. Diagnoses: An emergent bronchoscopy showed an actively bleeding, pulsatile vessel at the distal end of the left bronchial limb of the Y-stent. It was felt that the bleeding was caused by, or at least impacted by, the distal left bronchial limb of the Y-stent eroding into the airway wall. Interventions: We hypothesized that placement of oxidized regenerated cellulose (ORC) would provide initial hemostasis, and the subsequent placement of a biocompatible surgical sealant would lead to definitive resolution. Outcomes: ORC provided sufficient hemostasis and the subsequent synthetic polymer reinforced the tissue for complete cessation of the bleed. Lessons: The combined use of ORC and a biocompatible surgical sealant provided long-term management for life-threatening hemoptysis, and potentially morbid procedures such as embolization or surgery were avoided by advanced endobronchial therapy. PMID:29465600

Predictive factors for the failure of endoscopic stent-in-stent self-expandable metallic stent placement to treat malignant hilar biliary obstruction.

PubMed

Sugimoto, Mitsuru; Takagi, Tadayuki; Suzuki, Rei; Konno, Naoki; Asama, Hiroyuki; Watanabe, Ko; Nakamura, Jun; Kikuchi, Hitomi; Waragai, Yuichi; Takasumi, Mika; Sato, Yuki; Hikichi, Takuto; Ohira, Hiromasa

2017-09-14

To investigate the factors predictive of failure when placing a second biliary self-expandable metallic stents (SEMSs). This study evaluated 65 patients with an unresectable malignant hilar biliary obstruction who were examined in our hospital. Sixty-two of these patients were recruited to the study and divided into two groups: the success group, which consisted of patients in whom a stent-in-stent SEMS had been placed successfully, and the failure group, which consisted of patients in whom the stent-in-stent SEMS had not been placed successfully. We compared the characteristics of the patients, the stricture state of their biliary ducts, and the implemented endoscopic retrograde cholangiopancreatography (ERCP) procedures between the two groups. The angle between the target biliary duct stricture and the first implanted SEMS was significantly larger in the failure group than in the success group. There were significantly fewer wire or dilation devices (ERCP catheter, dilator, or balloon catheter) passing the first SEMS cell in the failure group than in the success group. The cut-off value of the angle predicting stent-in-stent SEMS placement failure was 49.7 degrees according to the ROC curve (sensitivity 91.7%, specificity 61.2%). Furthermore, the angle was significantly smaller in patients with wire or dilation devices passing the first SEMS cell than in patients without wire or dilation devices passing the first SEMS cell. A large angle was identified as a predictive factor for failure of stent-in-stent SEMS placement.

Reintervention for stent occlusion after bilateral self-expandable metallic stent placement for malignant hilar biliary obstruction.

PubMed

Inoue, Tadahisa; Naitoh, Itaru; Okumura, Fumihiro; Ozeki, Takanori; Anbe, Kaiki; Iwasaki, Hiroyasu; Nishie, Hirotada; Mizushima, Takashi; Sano, Hitoshi; Nakazawa, Takahiro; Yoneda, Masashi; Joh, Takashi

2016-11-01

Endoscopic reintervention for stent occlusions following bilateral self-expandable metallic stent (SEMS) placement for malignant hilar biliary obstruction (MHBO) is challenging, and time to recurrent biliary obstruction (RBO) of the revisionary stent remains unclear. We aimed to clarify a suitable reintervention method for stent occlusions following bilateral SEMS placement for MHBO. Between 2002 and 2014, 52 consecutive patients with MHBO who underwent endoscopic reintervention for stent occlusion after bilateral SEMS placement were enrolled at two university hospitals and one tertiary care referral center. We retrospectively evaluated the technical and functional success rates of the reinterventions, and the time to RBO of the revisionary stents. Technical and functional success rates of the reinterventions were 92% (48/52) and 90% (43/48), respectively. Univariate analysis did not determine any significant predictive factors for technical and functional failures. Median time to RBO of the revisionary stents was 68 days. Median time to RBO was significantly longer for revisionary SEMS placement than for plastic stent placement (131 days vs 47 days, respectively; log-rank test, P = 0.005). Revisionary SEMS placement was the only independent factor that was significantly associated with a longer time to RBO of the revisionary stent in the multivariate Cox proportional hazards analysis (hazard ratio 0.37; 95% confidence interval 0.14-0.95; P = 0.039). Revisionary SEMS placement is a suitable endoscopic reintervention method for stent occlusion following bilateral SEMS placement from the perspective of time to RBO of the revisionary stent. © 2016 Japan Gastroenterological Endoscopy Society.

Air cholangiography in endoscopic bilateral stent-in-stent placement of metallic stents for malignant hilar biliary obstruction.

PubMed

Lee, Jae Min; Lee, Sang Hyub; Jang, Dong Kee; Chung, Kwang Hyun; Park, Jin Myung; Paik, Woo Hyun; Lee, Jun Kyu; Ryu, Ji Kon; Kim, Yong-Tae

2016-03-01

Although endoscopic bilateral stent-in-stent (SIS) placement of self-expandable metallic stents (SEMS) is one of the major palliative treatments for unresectable malignant hilar biliary obstruction, post-endoscopic retrograde cholangiopancreatography (ERCP) cholangitis can occur frequently due to inadequate drainage, especially after contrast injection into the biliary tree. The aim of this study is to evaluate the efficacy and safety of air cholangiography-assisted stenting. This study included 47 patients with malignant hilar biliary obstruction who underwent endoscopic bilateral SEMS placement using the SIS technique. They were divided into two groups, air (n = 23) or iodine contrast (n = 24) cholangiography. We retrospectively compared comprehensive clinical and laboratory data of both groups. There were no significant differences found between the two groups with respect to technical success (87% versus 87.5%, air versus contrast group, respectively), functional success (95% versus 95.2%), 30-day mortality (8.3% versus 8.7%) and stent patency. Post-ERCP adverse events occurred in 5 (21.7%) of the patients in the air group and 8 (33.3%) of the patients in the contrast group. Among these, the rate of cholangitis was significantly lower in the air group (4.8% versus 29.2%, p = 0.048). In multivariate analysis, air cholangiography, technical success and a shorter procedure time were significantly associated with a lower incidence of post-ERCP cholangitis. Air cholangiography-assisted stenting can be a safe and effective method for endoscopic bilateral SIS placement of SEMS in patients with malignant hilar biliary obstruction.

The Stent Patency and Migration Rate of Different Shaped Plastic Stents in Bile Flow Phantom Model and In Vivo Animal Bile Duct Dilation Model.

PubMed

Kwon, Chang-Il; Kim, Gwangil; Jeong, Seok; Lee, Don Haeng; Kim, Kyoung Ah; Ko, Kwang Hyun; Cho, Joo Young; Hong, Sung Pyo

2017-05-01

In research and development of biliary plastic stents (PS), continuous efforts have been made to overcome short patency time and high rate of migration. The aim of this study was to evaluate the patency and migration rate of different PS shapes for a given period of time. Using an in vitro bile phantom model, we compared the patency among different shapes of PS (three straight PS, four double-pigtail PS, and a new screw-shaped PS). We performed an analysis of the degree of luminal narrowing by light microscopic examination. Using an in vivo swine model, we compared the patency and migration rate among the three different types of PS. Eight weeks after the bile exposure in the bile flow phantom model, 80 PS were retrieved and analyzed. The straight PS showed less biofilm formation and luminal narrowing than other types of PS (p < 0.05). Forty-nine PS were inserted into the dilated bile ducts of 10 swine models, and 39 PS were successfully retrieved 8 weeks later. The stent migration occurred less frequently in the double-pigtail PS and the screw-shaped PS than it did in the straight PS (11.1, 10, and 27.3%, respectively). However, there was no statistical difference in stent patency among the different shapes. Stent patency may not be significantly different depending on the shape of PS for 8 weeks. The screw-shaped PS showed similar patency and migration rate to the double-pigtail PS. These results may help guiding future PS development and clinical decisions.

Novel biliary self-expanding metal stents: indications and applications.

PubMed

Blero, Daniel; Huberty, Vincent; Devière, Jacques

2015-03-01

Endoscopic insertion of a self-expanding metal stent (SEMS) through a malignant common bile duct stricture is the first line of palliation for malignant jaundice. Patency of these stents remains a major concern. SEMS dysfunction can result from tumor ingrowth, overgrowth and/or clogging. Initial SEMS modifications involved covering the central part of the stent in order to reduce ingrowth and ultimately increase patency. Fully covered stents became available shortly after reports of their use in human patients. The potential removability and radial strength of SEMS have led to evaluation of their use in new indications including benign biliary strictures, post sphincterotomy bleeding and perforation. Other aspects of development include the addition of features such as anti-reflux valves, drug elution and spontaneous biodegradability. These aspects and their clinical implications are reviewed and discussed.

Treatment of congenital tracheal stenosis by balloon-expandable metallic stents in paediatric intensive care unit

PubMed Central

Xu, Xuan; Li, Dandan; Zhao, Shuyu; Liu, Xicheng; Feng, Zhichun; Ding, Hui

2012-01-01

The aim of this study was to evaluate the use of balloon-expandable metallic stents in the treatment of children with congenital tracheal stenosis in whom conventional therapy has failed. From 2010 to 2011, balloon-expandable metallic stents were implanted into the trachea of eight infants aged 2–20 months in the paediatric intensive care unit. The infants had severe airway obstruction caused by congenital tracheal stenosis. Tracheal stents were placed after intraluminal balloon dilatation of the tracheal stenosis, inserted with balloon catheters and implanted into the desired position bronchoscopically. The stents were 12 to 29 mm long and 4 mm in diameter. Seven children were relieved of airway obstruction after this procedure. However, a child died due to severe sepsis after the placement of bronchial stents. No granulation tissue developed over the stents in any of the children. Stents have been in place for 1–6 months after insertion without any other complication. Balloon-expandable metallic stents are effective in relieving airway obstruction by congenital tracheal stenosis in children. This technique may provide an important remedy for congenital tracheal stenosis in children. PMID:22361127

[A Case of Recurrent Stenosis after Metallic Stenting for Esophagogastric Junction Adenocarcinoma with Peritoneal Metastases].

PubMed

Hirakawa, Toshiki; Morimoto, Junya; Nakazawa, Kazunori; Miyamoto, Hironari; Okada, Takuma; Nobori, Chihoko; Kurihara, Shigeaki; Wang, En; Aomatsu, Naoki; Iwauchi, Takehiko; Yamagata, Shigehito; Uchima, Yasutake; Takeuchi, Kazuhiro

2017-11-01

A 65-year-old man presented with severe strictures from the esophagogastric junction to the body of the stomach and was histopathologically diagnosed with adenocarcinoma. Computed tomography showed multiple peritoneal metastases. A long, covered metallic stent was placed, and chemotherapy was started. Subsequent granulation from the oral side of the stent caused stricture formation, and a covered stent was also placed. After 8 months, granulation from the oral side of the stent caused recurrent stricture formation. We again placed a metallic stent. Successful chemotherapy for stomach cancer with long-term benefit is possible with new molecularly targeted drugs. Stenting may cause adverse events such as stenosis, but can enable oral intake and is minimally invasive. This report describes a case that required multiple stent placement and reviews the relevant literature.

Medium-term follow-up after deployment of ultraflex expandable metallic stents to manage endobronchial pathology.

PubMed

Madden, Brendan P; Park, John E S; Sheth, Abhijat

2004-12-01

Between March 1997 and March 2004 we deployed 80 Ultraflex metallic expandable stents (Boston Scientific, Waterson, MA) in 69 patients under direct vision using rigid bronchoscopy. We report our medium- to long-term experience in patients for whom these stents were deployed. To date 15 patients have been followed for more than 1 year (median 41 months, range 12 to 83 months) after stent deployment. Indications for stenting in these patients were neoplasia (5), stricture (5), airway malacia (1), iatrogenic tracheal tear (1), and compression from an aortic aneurysm (1), a right interrupted aortic arch (1), and a right brachiocephalic artery aneurysm with tracheomalacia (1). Ten tracheal stents (9 covered, 1 uncovered) and 10 bronchial stents (8 uncovered, 2 covered) were inserted, and 5 patients received two stents. Five of these patients experienced no long-term problems. Complications included troublesome halitosis (5), which was difficult to treat despite various antibiotic regimes; granulation tissue formation above and below the stent that was successfully treated with low-power Nd:YAG laser therapy (7); and metal fatigue (1). We did not encounter stent migration. We conclude that Ultraflex expandable metallic stents have an important role in the management of selected patients with diverse endobronchial pathologies and are well tolerated in the long-term. Although associated granulation tissue can be successfully treated with Nd:YAG laser, halitosis can be a difficult problem to address.

[The thermoformable spiral metallic stents in the treatment of localized ureteral stenosis: an alternative to JJ stent? Prospective multicenter study].

PubMed

Bonniol, R; Meria, P; Safsaf, A; Albouy, B; Sibert, L

2011-06-01

Evaluation of the effectiveness and tolerance of thermoformable metallic spiral stents Memokath(®) 051 (Bard, Pnn Medical) in the treatment of localized ureteral stenosis in non-operable patients who have JJ ureteral stents. Prospective, descriptive and multicenter study of patients with ureteral strictures treated with metallic ureteral stents Memokath(®) 051. Assessment criteria (recurrent stenotic, permeability, tolerance) were measured by clinical, biological and radiological examination at 1 month, and then every 3 months. Fifteen stents (average length: 9.15 cm, range 6-15 cm) were implanted in 14 patients (mean age: 55 years, range: 38-72 years) with secondary suspended ureteral stenosis during 2 years in two centers. The median follow-up was 11 months (range 6 to 24 months). Technical difficulty was observed with two patients. Stents are still up in four patients. The stenosis recurred in four patients with spontaneous progression of stenosis but without endoprosthetics tissue invasion. Two and three migration were observed with spontaneous expulsions. Two lower urinary infections and one high occurred, resolved on antibiotic therapy, no inlay or hematuria, no pain (mean VAS score=3/10) or urinary disorders of the lower unit have been identified. Stents Memokath(®) 051 are well tolered and seem to position themselves as an interesting alternative to JJ ureteral stent in some frails patients. The refinement of contraindication should help to improve the stent's efficacity and to reduce the risk of migration and expulsion. Copyright © 2011 Elsevier Masson SAS. All rights reserved.

An approach to tracheostomy in a patient with an expandable metallic tracheal stent.

PubMed

Madden, Brendan P; Sheth, Abhijat

2005-09-01

With increasing use of expandable metallic stents to manage patients with a variety of endobronchial pathologies, some will have a subsequent need for tracheostomy insertion. We describe a successful technique to insert a tracheostomy using rigid and fibre-optic bronchoscopy in a patient who had an 8 cm expandable metallic tracheal stent deployed previously on account of tracheomalacia.

Metallic Zinc Exhibits Optimal Biocompatibility for Bioabsorbable Endovascular Stents

PubMed Central

Bowen, Patrick K.; Guillory, Roger J.; Shearier, Emily R.; Seitz, Jan-Marten; Drelich, Jaroslaw; Bocks, Martin; Zhao, Feng; Goldman, Jeremy

2015-01-01

Although corrosion resistant bare metal stents are considered generally effective, their permanent presence in a diseased artery is an increasingly recognized limitation due to the potential for long-term complications. We previously reported that metallic zinc exhibited an ideal biocorrosion rate within murine aortas, thus raising the possibility of zinc as a candidate base material for endovascular stenting applications. This study was undertaken to further assess the arterial biocompatibility of metallic zinc. Metallic zinc wires were punctured and advanced into the rat abdominal aorta lumen for up to 6.5 months. This study demonstrated that metallic zinc did not provoke responses that often contribute to restenosis. Low cell densities and neointimal tissue thickness, along with tissue regeneration within the corroding implant, point to optimal biocompatibility of corroding zinc. Furthermore, the lack of progression in neointimal tissue thickness over 6.5 months or the presence of smooth muscle cells near the zinc implant suggest that the products of zinc corrosion may suppress the activities of inflammatory and smooth muscle cells. PMID:26249616

In-situ investigation of stress conditions during expansion of bare metal stents and PLLA-coated stents using the XRD sin(2)ψ-technique.

PubMed

Kowalski, Wolfgang; Dammer, Markus; Bakczewitz, Frank; Schmitz, Klaus-Peter; Grabow, Niels; Kessler, Olaf

2015-09-01

Drug eluting stents (DES) consist of platform, coating and drug. The platform often is a balloon-expandable bare metal stent made of the CoCr alloy L-605 or stainless steel 316 L. The function of the coating, typically a permanent polymer, is to hold and release the drug, which should improve therapeutic outcome. Before implantation, DES are compressed (crimped) to allow implantation in the human body. During implantation, DES are expanded by balloon inflation. Crimping, as well as expansion, causes high stresses and high strains locally in the DES struts, as well as in the polymer coating. These stresses and strains are important design criteria of DES. Usually, they are calculated numerically by finite element analysis (FEA), but experimental results for validation are hardly available. In this work, the X-ray diffraction (XRD) sin(2)ψ-technique is applied to in-situ determination of stress conditions of bare metal L-605 stents, and Poly-(L-lactide) (PLLA) coated stents. This provides a realistic characterization of the near-surface stress state and a validation option of the numerical FEA. XRD-results from terminal stent struts of the bare metal stent show an increasing compressive load stress in tangential direction with increasing stent expansion. These findings correlate with numerical FEA results. The PLLA-coating also bears increasing compressive load stress during expansion. Copyright © 2015 Elsevier Ltd. All rights reserved.

Predictive factors for the failure of endoscopic stent-in-stent self-expandable metallic stent placement to treat malignant hilar biliary obstruction

PubMed Central

Sugimoto, Mitsuru; Takagi, Tadayuki; Suzuki, Rei; Konno, Naoki; Asama, Hiroyuki; Watanabe, Ko; Nakamura, Jun; Kikuchi, Hitomi; Waragai, Yuichi; Takasumi, Mika; Sato, Yuki; Hikichi, Takuto; Ohira, Hiromasa

2017-01-01

AIM To investigate the factors predictive of failure when placing a second biliary self-expandable metallic stents (SEMSs). METHODS This study evaluated 65 patients with an unresectable malignant hilar biliary obstruction who were examined in our hospital. Sixty-two of these patients were recruited to the study and divided into two groups: the success group, which consisted of patients in whom a stent-in-stent SEMS had been placed successfully, and the failure group, which consisted of patients in whom the stent-in-stent SEMS had not been placed successfully. We compared the characteristics of the patients, the stricture state of their biliary ducts, and the implemented endoscopic retrograde cholangiopancreatography (ERCP) procedures between the two groups. RESULTS The angle between the target biliary duct stricture and the first implanted SEMS was significantly larger in the failure group than in the success group. There were significantly fewer wire or dilation devices (ERCP catheter, dilator, or balloon catheter) passing the first SEMS cell in the failure group than in the success group. The cut-off value of the angle predicting stent-in-stent SEMS placement failure was 49.7 degrees according to the ROC curve (sensitivity 91.7%, specificity 61.2%). Furthermore, the angle was significantly smaller in patients with wire or dilation devices passing the first SEMS cell than in patients without wire or dilation devices passing the first SEMS cell. CONCLUSION A large angle was identified as a predictive factor for failure of stent-in-stent SEMS placement. PMID:28974893

A new polymer-free drug-eluting stent with nanocarriers eluting sirolimus from stent-plus-balloon compared with bare-metal stent and with biolimus A9 eluting stent in porcine coronary arteries.

PubMed

Takimura, Celso K; Galon, Micheli Z; Gutierrez, Paulo S; Sojitra, Prakash; Vyas, Ashwin; Doshi, Manish; Lemos, Pedro A

2015-04-01

Permanent polymers in first generation drug-eluting stent (DES) have been imputed to be a possible cause of persistent inflammation, remodeling, malapposition and late stent thrombosis. We aim to describe the in vivo experimental result of a new polymer-free DES eluting sirolimus from stent-plus-balloon (Focus np stent, Envision Scientific) compared with a bare-metal stent (BMS) (Amazonia CroCo, Minvasys) and with a biolimus A9 eluting stent (Biomatrix, Biosensors). In 10 juvenile pigs, 23 coronary stents were implanted in the coronary arteries (8 Amazonia CroCo, 8 Focus np, and 7 Biomatrix). At 28-day follow-up, optical coherence tomography (OCT) and histology were used to evaluate neointimal hyperplasia and healing response. According to OCT analysis, Focus np stents had a greater lumen area and less neointimal hyperplasia response than BMS and Biomatrix had. Histomorphometry results showed less neointimal hyperplasia in Focus np than in BMS. Histology showed a higher fibrin deposition in Biomatrix stent compared to Focus np and BMS. The new polymer-free DES with sirolimus eluted from stent-plus-balloon demonstrated safety and reduced neointimal proliferation compared with the BMS and Biomatrix stents at 28-day follow-up in this porcine coronary model. This new polymer-free DES is promising and warrants further clinical studies.

Frequency of Angina Pectoris After Percutaneous Coronary Intervention and the Effect of Metallic Stent Type.

PubMed

Gaglia, Michael A; Torguson, Rebecca; Lipinski, Michael J; Gai, Jiaxiang; Koifman, Edward; Kiramijyan, Sarkis; Negi, Smita; Rogers, Toby; Steinvil, Arie; Suddath, William O; Satler, Lowell F; Pichard, Augusto D; Waksman, Ron

2016-02-15

Although metallic coronary stents significantly reduce angina pectoris compared with optimal medical therapy, angina after percutaneous coronary intervention (PCI) remains frequent. We, therefore, sought to compare the incidence of any angina during the 1 year after PCI among the spectrum of commercially available metallic stents. Metallic stent type was classified as bare metal stent, Cypher, Taxus Express, Xience V, Promus Element, and Resolute. The primary end point was patient-reported angina within 1 year of PCI. Multivariable logistic regression was performed to assess the independent association of stent type with any angina at 1 year. Overall, 8,804 patients were queried in regard to angina symptoms; 32.3% experienced angina at some point in the first year after PCI. Major adverse cardiovascular events, a composite of all-cause mortality, target vessel revascularization, and Q-wave myocardial infarction, increased with angina severity: 6.8% for patients without angina, 10.0% for patients with class 1 or 2 angina, and 19.7% for patients with class 3 or 4 angina (p <0.001 for trend). After multivariable adjustment, there was no significant association between stent type and angina at 1 year after PCI. Baseline Canadian Cardiovascular Society class 3 or 4 angina, history of coronary artery bypass grafting, and history of PCI were associated with a higher likelihood of angina at 1 year; increasing age, male gender, presentation with acute coronary syndrome, and higher stented length were associated with less angina. In conclusion, metallic stent type is not associated with the occurrence of angina at up to 1 year after PCI. Copyright © 2016 Elsevier Inc. All rights reserved.

Single brand, fully-covered, self-expandable metal stent for the treatment of benign biliary disease: when should stents be removed?

PubMed

Mangiavillano, Benedetto; Khashab, Mouen A; Eusebi, Leonardo H; Tarantino, Ilaria; Bianchetti, Mario; Semeraro, Rossella; Pellicano, Rinaldo; Traina, Mario; Repici, Alessandro

2018-05-31

The two most relevant endoscopic treatable benign biliary diseases (BBD) are benign biliary strictures (BBSs) and biliary leaks (BLs), often associated with high morbidity. The most common endoscopic treatment for biliary strictures involves placement of multiple plastic stents (PSs), with or without balloon dilation, followed by planned exchange of the stents. Thus, there continues to be high interest in pursuing alternative endoscopic approaches that may achieve better results with fewer interventions. In this setting, the use of a fully-covered, self-expandable metal stent (FCSEMS) is an attractive alternative to single or multiple PSs for the treatment of BBDs. A single metal stent can remain in place for a longer period of time before removal; however, the maximum time the stent can be remain in place is still not well defined. The aim of this review is to determine the removal time of the TaeWoong® FCSEMS, placed for BBD. According to our data analysis, considering the absence of loss of the covering of the FCSEMS and of any adverse events during and after stent removal, leaving the TaeWoong medical FCSEMS in situ for an 8 months' period seems to be acceptable for benign biliary diseases. Further studies need to evaluate their removability at 1 year.

Risk of stent thrombosis among bare-metal stents, first-generation drug-eluting stents, and second-generation drug-eluting stents: results from a registry of 18,334 patients.

PubMed

Tada, Tomohisa; Byrne, Robert A; Simunovic, Iva; King, Lamin A; Cassese, Salvatore; Joner, Michael; Fusaro, Massimiliano; Schneider, Simon; Schulz, Stefanie; Ibrahim, Tareq; Ott, Ilka; Massberg, Steffen; Laugwitz, Karl-Ludwig; Kastrati, Adnan

2013-12-01

This study sought to compare the risk of stent thrombosis among patients treated with bare-metal stents (BMS), first-generation drug-eluting stents (G1-DES), and second-generation drug-eluting stents (G2-DES) for a period of 3 years. In patients undergoing coronary stenting, there is a scarcity of long-term follow-up data on cohorts large enough to compare rates of stent thrombosis across the stent generations. A total of 18,334 patients undergoing successful coronary stent implantation from 1998 to 2011 at 2 centers in Munich, Germany, were included in this study. Patients were stratified into 3 groups according to treatment with BMS, G1-DES, and G2-DES. The cumulative incidence of definite stent thrombosis at 3 years was 1.5% with BMS, 2.2% with G1-DES, and 1.0% with G2-DES. On multivariate analysis, G1-DES compared with BMS showed a significantly higher risk of stent thrombosis (odds ratio [OR]: 2.05; 95% confidence interval [CI]: 1.47 to 2.86; p < 0.001). G2-DES were associated with a similar risk of stent thrombosis compared with BMS (OR: 0.82; 95% CI: 0.56 to 1.19; p = 0.30). Beyond 1 year, the risk of stent thrombosis was significantly increased with G1-DES compared with BMS (OR: 4.72; 95% CI: 2.01 to 11.1; p < 0.001), but not with G2-DES compared with BMS (OR: 1.01; 95% CI: 0.32 to 3.25; p = 0.98). In a large cohort of unselected patients undergoing coronary stenting, compared with BMS, there was a significant excess risk of stent thrombosis at 3 years with G1-DES, driven by an increased risk of stent thrombosis events beyond 1 year. G2-DES were associated with a similar risk of stent thrombosis compared with BMS. Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Metallic Stents for Proximal Tracheal Stenosis: Is It Worth the Risk?

PubMed Central

Bansal, Sandeep; Dhingra, Shruti; Ghai, Babita; Gupta, Ashok K.

2012-01-01

Objective. To demonstrate the risk associated with blocked proximal tracheal stents when a patient presents with acute respiratory distress, with blockage of stent and what is the best management we can offer without damage to the stent and its associated complications. Case Report. A 22-yr-old, male patient, presented in severe respiratory distress. He had history of corrosive poisoning for which he was tracheotomised. A stainless steel wire mesh stent was placed in the trachea, from the subglottis, to just above the carina. One month later, he presented with a critically compromised airway with severe respiratory distress. Emergency tracheostomy was done and the metallic stent had to be cut open, in order to provide an airway. Conclusion. Management of blocked proximal stents with patient in respiratory distress remains a challenge. Formation of granulation tissue is common and fibreoptic bronchoscopic assisted intubation may not always be possible. A regular follow up of all patients with stents is essential. Placement of stents within a few centimetres of cricotracheal junction should not be encouraged for long term indications. PMID:22953113

Successful management of a benign anastomotic colonic stricture with self-expanding metallic stents: A case report

PubMed Central

Guan, Yong-Song; Sun, Long; Li, Xiao; Zheng, Xiao-Hua

2004-01-01

AIM: To assess the effectiveness of and complications associated with metallic stent placement for treatment of anastomotic colonic strictures. METHODS: A 46-year-old man underging two procedures of surgery for perforation of descending colon due to a traffic accident presented with pain, abdominal distention, and inability to defecate. Single-contrast barium enema radiograph showed a severe stenosis in the region of surgical anastomosis and the patient was too weak to accept another laparotomy. Under fluoroscopic and endoscopic guidance, we placed two metallic stents in the stenosis site of the anastomosis of the patient with anastomotic colonic strictures. RESULTS: In this case of postsurgical stenosis, the first stent relieved the symptoms of obstruction, but stent migration happened on the next day so an additional stent was required to deal with the stricture and relieve the symptoms. CONCLUSION: This case confirms that metallic stenting may represent an effective treatment for anastomotic colonic strictures in the absence of other therapeutic alternatives. PMID:15526381

A new polymer-free drug-eluting stent with nanocarriers eluting sirolimus from stent-plus-balloon compared with bare-metal stent and with biolimus A9 eluting stent in porcine coronary arteries

PubMed Central

Galon, Micheli Z.; Gutierrez, Paulo S.; Sojitra, Prakash; Vyas, Ashwin; Doshi, Manish; Lemos, Pedro A.

2015-01-01

Background Permanent polymers in first generation drug-eluting stent (DES) have been imputed to be a possible cause of persistent inflammation, remodeling, malapposition and late stent thrombosis. We aim to describe the in vivo experimental result of a new polymer-free DES eluting sirolimus from stent-plus-balloon (Focus np stent, Envision Scientific) compared with a bare-metal stent (BMS) (Amazonia CroCo, Minvasys) and with a biolimus A9 eluting stent (Biomatrix, Biosensors). Methods In 10 juvenile pigs, 23 coronary stents were implanted in the coronary arteries (8 Amazonia CroCo, 8 Focus np, and 7 Biomatrix). At 28-day follow-up, optical coherence tomography (OCT) and histology were used to evaluate neointimal hyperplasia and healing response. Results According to OCT analysis, Focus np stents had a greater lumen area and less neointimal hyperplasia response than BMS and Biomatrix had. Histomorphometry results showed less neointimal hyperplasia in Focus np than in BMS. Histology showed a higher fibrin deposition in Biomatrix stent compared to Focus np and BMS. Conclusions The new polymer-free DES with sirolimus eluted from stent-plus-balloon demonstrated safety and reduced neointimal proliferation compared with the BMS and Biomatrix stents at 28-day follow-up in this porcine coronary model. This new polymer-free DES is promising and warrants further clinical studies. PMID:25984451

Intravascular local gene transfer mediated by protein-coated metallic stent.

PubMed

Yuan, J; Gao, R; Shi, R; Song, L; Tang, J; Li, Y; Tang, C; Meng, L; Yuan, W; Chen, Z

2001-10-01

To assess the feasibility, efficiency and selectivity of adenovirus-mediated gene transfer to local arterial wall by protein-coated metallic stent. A replication-defective recombinant adenovirus carrying the Lac Z reporter gene for nuclear-specific beta-galactosidase (Ad-beta gal) was used in this study. The coating for metallic stent was made by immersing it in a gelatin solution containing crosslinker. The coated stents were mounted on a 4.0 or 3.0 mm percutaneous transluminal coronary angioplasty (PTCA) balloon and submersed into a high-titer Ad-beta gal viral stock (2 x 10(10) pfu/ml) for 3 min, and then implanted into the carotid arteries in 4 mini-swines and into the left anterior descending branch of the coronary artery in 2 mini-swines via 8F large lumen guiding catheters. The animals were sacrificed 7 (n = 4), 14 (n = 1) and 21 (n = 1) days after implantation, respectively. The beta-galactosidase expression was assessed by X-gal staining. The results showed that the expression of transgene was detected in all animal. In 1 of carotid artery with an intact intima, the beta-gal expression was limited to endothelial cells. In vessels with denuded endothelium, gene expression was found in the sub-intima, media and adventitia. The transfection efficiency of medial smooth muscle cells was 38.6%. In 2 animals sacrificed 7 days after transfection, a microscopic examination of X-gal-stained samples did not show evidence of transfection in remote organs and arterial segments adjacent to the treated arterial site. Adenovirus-mediated arterial gene transfer to endothelial, smooth muscle cells and adventitia by protein-coated metallic stent is feasible. The transfection efficiency is higher. The coated stent may act as a good carrier of adenovirus-mediated gene transfer and have a potential to prevent restenosis following PTCA.

Drug eluting stents and modern stent technologies for in-stent restenosis.

PubMed

Werner, Martin

2017-08-01

The implantation of metallic stents has become a standard procedure to improve the outcome after angioplasty of peripheral vessels. However, the occurrence of in-stent restenosis is hampering the long-term efficacy of these procedures and is associated with re-occurrence of symptoms. The optimal treatment modality for in-stent-restenosis in the peripheral vasculature is not well examined. This review discusses the existing evidence for the treatment of in-stent restenosis with drug eluting stents and modern stent technologies.

Comparison of the utility of covered metal stents versus uncovered metal stents in the management of malignant biliary strictures in 749 patients.

PubMed

Lee, Jeffrey H; Krishna, Somashekar G; Singh, Amanpal; Ladha, Harshad S; Slack, Rebecca S; Ramireddy, Srinivas; Raju, Gottumukkala S; Davila, Marta; Ross, William A

2013-08-01

Self-expandable metal stents (SEMSs) are used to relieve malignant biliary obstruction. To compare outcomes between covered self-expandable metal stents (CSEMSs) and uncovered self-expandable metal stents (USEMSs) in malignant biliary obstruction. Retrospective cohort study. Tertiary cancer center. Patients with malignant biliary obstruction. Placement of CSEMS or USEMS. Time to recurrent biliary obstruction (TRO), overall survival (OS), and adverse events. From January 2000 to June 2011, 749 patients received SEMSs: 171 CSEMSs and 578 USEMSs. At 1 year, there was no significant difference in the percentage of patients with recurrent obstruction (CSEMSs, 35% vs USEMSs, 38%) and survival (CSEMSs, 45% vs USEMSs, 49%). There was no significant difference in the median OS (CSEMSs, 10.4 months vs USEMSs, 11.8 months; P = .84) and the median TRO (CSEMSs, 15.4 months vs USEMSs, 26.3 months; P = .61). The adverse event rate was 27.5% for the CSEMS group and 27.7% for the USEMS group. Although tumor ingrowth with recurrent obstruction was more common in the USEMS group (76% vs 9%, P < .001), stent migration (36% vs 2%, P < .001) and acute pancreatitis (6% vs 1%, P < .001) were more common in the CSEMS group. Retrospective study. There was no significant difference in the patency rate or overall survival between CSEMSs and USEMSs for malignant distal biliary strictures. The CSEMS group had a significantly higher rate of migration and pancreatitis than the USEMS group. No significant SEMS-related adverse events were observed in patients undergoing neoadjuvant chemoradiation or surgical resection. Copyright © 2013 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

Covered metal stent or multiple plastic stents for refractory pancreatic ductal strictures in chronic pancreatitis: a systematic review.

PubMed

Shen, Yonghua; Liu, Mingdong; Chen, Min; Li, Yunhong; Lu, Ying; Zou, Xiaoping

2014-01-01

Refractory chronic pancreatitis has been proposed as a challenge for endoscopists following routine single plastic stenting. However, data on the efficacy and safety of further endoscopic stenting are still controversial. The current systematic review aimed to assess the efficacy and safety of placement of fully covered self-expandable metal stent (FCSEMS) and multiple plastic stents. Databases including MEDLINE, EMBASE, the Cochrane Library, CBM, CNKI, VIP, and WANFANG Database were used to search relevant trials. Published studies were assessed by using well-defined inclusion and exclusion criteria. The process was independently performed by two investigators. A total of 5 studies provided data of 80 patients. Forest plots and publication bias were not carried out because few studies were relevant and screened studies were all case series. The technical success rate was 100% both in placement of FCSEMS and multiple plastic stents. The functional success rate after placement of FCSEMS was 100%, followed by multiple plastic stents (94.7%). Complications occurred 26.2% after FCSEMS placement, which was not described in detail in multiple plastic stents. The stent migration rate was 8.2% for FCSEMS and 10.5% for multiple plastic stents. Reintervention rate was 9.8% for FCSEMS and 15.8% for multiple plastic stents. Pain improvement rate was 85.2% for FCSEMS and 84.2% for multiple plastic stents. FCSEMS appeared to be no significant difference with multiple plastic stents in treatment of refractory chronic pancreatitis. We need to develop more investigations. Copyright © 2014 IAP and EPC. Published by Elsevier B.V. All rights reserved.

Metal or plastic stents for preoperative biliary drainage in resectable pancreatic cancer.

PubMed

Tol, J A M G; van Hooft, J E; Timmer, R; Kubben, F J G M; van der Harst, E; de Hingh, I H J T; Vleggaar, F P; Molenaar, I Q; Keulemans, Y C A; Boerma, D; Bruno, M J; Schoon, E J; van der Gaag, N A; Besselink, M G H; Fockens, P; van Gulik, T M; Rauws, E A J; Busch, O R C; Gouma, D J

2016-12-01

In pancreatic cancer, preoperative biliary drainage (PBD) increases complications compared with surgery without PBD, demonstrated by a recent randomised controlled trial (RCT). This outcome might be related to the plastic endoprosthesis used. Metal stents may reduce the PBD-related complications risk. A prospective multicentre cohort study was performed including patients with obstructive jaundice due to pancreatic cancer, scheduled to undergo PBD before surgery. This cohort was added to the earlier RCT (ISRCTN31939699). The RCT protocol was adhered to, except PBD was performed with a fully covered self-expandable metal stent (FCSEMS). This FCSEMS cohort was compared with the RCT's plastic stent cohort. PBD-related complications were the primary outcome. Three-group comparison of overall complications including early surgery patients was performed. 53 patients underwent PBD with FCSEMS compared with 102 patients treated with plastic stents. Patients' characteristics did not differ. PBD-related complication rates were 24% in the FCSEMS group vs 46% in the plastic stent group (relative risk of plastic stent use 1.9, 95% CI 1.1 to 3.2, p=0.011). Stent-related complications (occlusion and exchange) were 6% vs 31%. Surgical complications did not differ, 40% vs 47%. Overall complication rates for the FCSEMS, plastic stent and early surgery groups were 51% vs 74% vs 39%. For PBD in pancreatic cancer, FCSEMS yield a better outcome compared with plastic stents. Although early surgery without PBD remains the treatment of choice, FCSEMS should be preferred over plastic stents whenever PBD is indicated. Dutch Trial Registry (NTR3142). Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Application of self-expandable metal stents for ureteroileal anastomotic strictures: long-term results.

PubMed

Liatsikos, Evangelos N; Kagadis, George C; Karnabatidis, Dimitrios; Katsanos, Konstantinos; Papathanassiou, Zafiria; Constantinides, Constantinos; Perimenis, Petros; Nikiforidis, George C; Stolzenburg, Jens-Uwe; Siablis, Dimitrios

2007-07-01

We report our long-term experience with the management of benign ureteroileal anastomotic strictures using self-expandable metal stents. A total of 16 male and 2 female patients with a mean+/-SD age of 72+/-7 years (range 66 to 78) with benign fibrotic strictures at the site of ureteroileal anastomosis underwent implantation of self-expandable metal stents with a nominal diameter of 6 to 8 mm. A total of 24 ureteroileal conduits were treated. The external nephrostomy tubes were removed after fluoroscopic validation of ureteral patency. Patients were followed with blood biochemistry, ultrasonography, urography and/or virtual endoscopy. Retrograde external-internal catheter insertion through the cutaneous stoma was performed in cases of recalcitrant stricture. The technical success rate of ureteroileal stricture crossing and stenting was 100% (24 of 24 cases). Mean followup was 21 months (range 7 to 50). The clinical success rate during the immediate post-stenting period was 70.8% (17 of 24 cases). The 1 and 4-year primary patency rates were 37.8% and 22.7%, respectively. Secondary interventions included repeat balloon dilation in 15 ureters, of which 8 also underwent subsequent coaxial stent placement. The 1 and 4-year secondary patency rates were 64.8% and 56.7%, respectively. Except in 2 patients who died external-internal Double-J catheters continued to be inserted retrograde in 6 ureteroileal conduits. They are periodically exchanged to prevent mucous inspissation and stent encrustation. Metal stents served as the definitive treatment for stricture in more than half of the cases, whereas in the remainder the stents allowed the uncomplicated and regular exchange of Double-J catheters in retrograde fashion. This combined, less invasive treatment for ureteroileal anastomotic strictures may help patients avoid surgical revision and preserve quality of life.

Self-Expandable Metallic Stent Placement for the Palliation of Esophageal Cancer.

PubMed

Kim, Kun Yung; Tsauo, Jiaywei; Song, Ho Young; Kim, Pyeong Hwa; Park, Jung Hoon

2017-07-01

Esophageal stents have been used to palliate patients with dysphagia caused by esophageal cancer. Early rigid plastic prostheses have been associated with a high risk of complications. However, with the development of self-expanding stents, it has developed into a widely accepted method for treating malignant esophageal strictures and esophagorespiratory fistulas (ERFs). The present review covers various aspects of self-expanding metallic stent placement for palliating esophageal cancer, including its types, placement procedures, indications, contraindications, complications, and some of innovations that will become available in the future. © 2017 The Korean Academy of Medical Sciences.

Self-Expandable Metallic Stent Placement for the Palliation of Esophageal Cancer

PubMed Central

2017-01-01

Esophageal stents have been used to palliate patients with dysphagia caused by esophageal cancer. Early rigid plastic prostheses have been associated with a high risk of complications. However, with the development of self-expanding stents, it has developed into a widely accepted method for treating malignant esophageal strictures and esophagorespiratory fistulas (ERFs). The present review covers various aspects of self-expanding metallic stent placement for palliating esophageal cancer, including its types, placement procedures, indications, contraindications, complications, and some of innovations that will become available in the future. PMID:28581260

[Trimming with argon plasma of self-expanding metal stents: report of 7 cases].

PubMed

Jury, Gastón; Amieva, Leandro; López, Fagalde Rafael; Jury, Rubén

2014-06-01

The use of self-expandable enteral stents for palliation of malignant stenosis may present the complication of concealing the ampulla of Vater behind the metallic mesh. Anchoring in the duodenal wall (distal or partial migration) may also be a complication of biliary metallic stents and therefore may cause difficulty in gaining access to the biliary tract. In these cases of difficult access, a fenestration on the prosthesis ( biliary or enteral) can be created to allow reaching the obstructed biliary tract by means of argon plasma (AP). Were retrospectively analysed 7 cases. Under endoscopic vision, AP was directed to filgurate and cut 6 biliary prosthesis and a duodenal stent. Fulguration and cut of biliary stent was performed in 5 cases of distal partial migration and cholangitis. In one case of obstruction caused by distal migration inside the duodenal stent light, cutting of the biliary stent was performed. A window was created in the enteral prosthesis in order to access the ampulla of Vater and place a biliary tract prosthesis. All cases were resolved successfully and without complications. We conclude that the use of AP to fulgurate and cut nitinol prosthesis was effective and presented no complications in this series.

Everolimus-Eluting Stents in Patients With Bare-Metal and Drug-Eluting In-Stent Restenosis: Results From a Patient-Level Pooled Analysis of the RIBS IV and V Trials.

PubMed

Alfonso, Fernando; Pérez-Vizcayno, María José; García Del Blanco, Bruno; García-Touchard, Arturo; López-Mínguez, José-Ramón; Masotti, Mónica; Zueco, Javier; Melgares, Rafael; Mainar, Vicente; Moreno, Raul; Domínguez, Antonio; Sanchís, Juan; Bethencourt, Armando; Moreu, José; Cequier, Angel; Martí, Vicens; Otaegui, Imanol; Bastante, Teresa; Gonzalo, Nieves; Jiménez-Quevedo, Pilar; Cárdenas, Alberto; Fernández, Cristina

2016-07-01

Treatment of patients with drug-eluting stent (DES) in-stent restenosis (ISR) is more challenging than that of patients with bare-metal stent ISR. However, the results of everolimus-eluting stents (EES) in these distinct scenarios remain unsettled. A pooled analysis of the RIBS IV (Restenosis Intra-Stent of Drug-Eluting Stents: Paclitaxel-Eluting Balloon vs Everolimus-Eluting Stent) and RIBS V (Restenosis Intra-Stent of Bare Metal Stents: Paclitaxel-Eluting Balloon vs Everolimus-Eluting Stent) randomized trials was performed using patient-level data to compare the efficacy of EES in bare-metal stent ISR and DES-ISR. Inclusion and exclusion criteria were identical in both trials. Results of 94 patients treated with EES for bare-metal stent ISR were compared with those of 155 patients treated with EES for DES-ISR. Baseline characteristics were more adverse in patients with DES-ISR, although they presented later and more frequently with a focal pattern. After intervention, minimal lumen diameter (2.22±0.5 versus 2.38±0.5 mm, P=0.01) was smaller in the DES-ISR group. Late angiographic findings (89.3% of eligible patients), including minimal lumen diameter (2.03±0.7 versus 2.36±0.6 mm, P<0.001) and diameter stenosis (23±22 versus 13±17%, P<0.001) were poorer in patients with DES-ISR. Results were consistent in the in-segment and in-lesion analyses. On multiple linear regression analysis, minimal lumen diameter at follow-up remained significantly smaller in patients with DES-ISR. Finally, at 1-year clinical follow-up (100% of patients), mortality (2.6 versus 0%, P<0.01) and need for target vessel revascularization (8 versus 2%, P=0.03) were higher in the DES-ISR group. This patient-level pooled analysis of the RIBS IV and RIBS V randomized clinical trials suggests that EES provide favorable outcomes in patients with ISR. However, the results of EES are less satisfactory in patients with DES-ISR than in those with bare-metal stent ISR. URL: http

Fully Covered Self-Expandable Metal Stents for Treatment of Both Benign and Malignant Biliary Disorders

PubMed Central

Abdel Samie, Ahmed; Theilmann, Lorenz

2012-01-01

Transpapillary stents are increasingly being used for biliary strictures, whether benign or malignant. However, there are different stent types and available data is controversial. Recently, completely covered self-expandable metal stents (CSEMSs) have been proposed as an alternative therapeutic option in different biliary indications, including strictures of the distal bile duct, anastomotic stenosis after orthotopic liver transplantation, bile duct leaks, periampullary perforation following endoscopic sphincterotomy (ES), and postsphincterotomy bleeding. Despite the higher costs of these devices, fully covered self-expanding metal stents seem to be a suitable therapeutic option to relief biliary obstruction due to bile duct stenosis, regardless of the underlying cause. PMID:22761543

Placement of retrievable self-expandable metallic stents with barbs into patients with obstructive prostate cancer.

PubMed

Song, Ho-Young; Kim, Choung Soo; Jeong, In Gab; Yoo, Dalsan; Kim, Jin Hyoung; Nam, Deok Ho; Bae, Jae-Ik; Park, Jung-Hoon

2013-03-01

To evaluate the technical feasibility and clinical effectiveness of retrievable self-expandable metallic stents with barbs in patients with obstructive prostate cancer. Retrievable self-expandable metallic stents with eight barbs each were inserted into eight consecutive patients with obstructive prostate cancer. Patient ages ranged from 55 to 76 years (mean, 69 years). All eight patients had previously received hormone therapy, and three had undergone palliative transurethral prostatectomy. Stents were removed using a 21-F stent removal set if they caused complications. Stent placement was technically successful and well tolerated in all patients. One had severe incontinence, which improved spontaneously, and two had gross haematuria, which disappeared spontaneously within 4 days. Peak urine flow rates and post-void residual urine volumes 1 month after stent placement were 5.6-10.2 ml/s (mean, 8.3 ml/s), and 5-45 ml (mean, 27 ml), respectively. During a mean follow-up of 192 days (range, 39-632 days), one patient required stent removal after 232 days because of stone formation within the stent. No further intervention was required because the mass improved after stent removal. These preliminary results suggest that retrievable stents with eight barbs are both feasible to place and effective in patients with obstructive prostate cancer.

Effects of heat treatment on shape-setting and non-linearmechanical properties of Nitinol stent

NASA Astrophysics Data System (ADS)

Liu, Xiaopeng; Wang, Yinong; Qi, Min; Yang, Dazhi

2007-07-01

NiTi shape memory alloy is a temperature sensitive material with non-linear mechanical properties and good biocompatibility, which can be used for medical devices such as stent, catheter guide wire and orthodontic wire. The majority of nitinol stents are of the self-expanding type basing on the superelasticity. Nitinol stents are shape set into the open condition and compressed and inserted into the delivery catheter. Additional the shape-setting treatment can be used as a tool to accurately tune the transformation temperatures and mechanical properties. In this study, different heat treatments have been performed on the Ti-50.7at%Ni alloy wires. And results of shape-setting, austenite transformation finish temperature and non-linear mechanical property of NiTi shape memory alloy at body temperature have been investigated. The experimental results show that the proper shape-setting temperature should be chosen between 450-550 °C. And the shape-setting results were stabilization when the NiTi wires were constrain-treated at 500 and 550°C and ageing time longer than 10 minutes. The austenite finish temperatures increased with ageing time and increased first and then decreased with ageing temperature. The peak values were obtained at 400°C. When the heat treatments was performed at the same temperature, both the upper plateau stresses and lower plateau stresses decreased with the ageing time. Most of treated nitinol wires owned good recovery ability at body temperature and the permanent sets were less than 0.05% when short time ageing treatment was performed at 500°C.

Self-expandable metal stents in the treatment of benign anastomotic stricture after rectal resection for cancer.

PubMed

Lamazza, A; Fiori, E; Sterpetti, A V; Schillaci, A; Scoglio, D; Lezoche, E

2014-04-01

To evaluate the use of self-expandable metallic stents to treat patients with symptomatic benign anastomotic stricture after colorectal resection. Ten patients with a benign symptomatic anastomotic stricture after colorectal resection were treated with endoscopic placement of a self-expandable metal stent. The stent was placed successfully in all 10 patients without any major morbidity. At a mean follow-up of 18 months the stenosis was resolved successfully in 7 out 10 patients (70%). The remaining three patients were subsequently treated successfully with balloon dilatation. Self-expandable metal stents represent a valid alternative to balloon dilatation to treat patients with benign symptomatic anastomotic stricture after colorectal resection for cancer. Colorectal Disease © 2013 The Association of Coloproctology of Great Britain and Ireland.

Bilateral metal stents for hilar biliary obstruction using a 6Fr delivery system: outcomes following bilateral and side-by-side stent deployment.

PubMed

Law, Ryan; Baron, Todd H

2013-09-01

Controversy exists on optimal endoscopic management for palliation of malignant hilar obstruction, with advocates for metal "side-by-side" (SBS) and "stent-in-stent" (SIS) techniques. We sought to evaluate the technical feasibility, efficacy, and outcomes of bilateral biliary self-expanding metal stents (SEMS) for treatment of malignant hilar obstruction using a stent with a 6Fr delivery system. This was a single-center, retrospective review of all patients who underwent bilateral placement of Zilver® biliary SEMS for malignant hilar obstruction from January 2010 to August 2012. Patients underwent endoscopic retrograde cholangiopancreatography with placement of stents using either the SIS or SBS stent techniques. Twenty-four patients (19 men, mean age 63 years) underwent bilateral stenting for malignant hilar obstruction during the study period. Seventeen and seven patients underwent the SBS and SIS technique, respectively. Cholangiocarcinoma (n=14) was the most common cause of hilar obstruction. Initial technical success was achieved in 24/24 (100%) of patients; however, 12 (50%) patients required re-intervention during the study period (median 98 days). Comparison of the SBS and SIS groups revealed no statistical difference with respect to need for re-intervention (P=0.31), successful re-intervention (P=0.60), or procedural length (P=0.89). Use of bilateral Zilver® SEMS in either the SBS or SIS configuration is safe, technically feasible, and effective for drainage of malignant hilar obstruction; however, duration of stent patency and procedure-free survival remain variable.

Evaluation of balloon withdrawal forces with bare-metal stents, compared with Taxus and Cypher drug-eluting coronary stents: balloon, stent and polymer interactions.

PubMed

Turk, Marvee; Gupta, Vishal; Fischell, Tim A

2010-03-01

There have been reports of serious complications related to difficulty removing the deflated Taxus stent delivery balloon after stent deployment. The purpose of this study was to determine whether the Taxus SIBS polymer was "sticky" and associated with an increase in the force required to remove the stent delivery balloon after stent deployment, using a quantitative, ex-vivo model. Balloon-polymer-stent interactions during balloon withdrawal were measured with the Taxus Liberté, Liberté bare-metal stent (BMS; no polymer = control), the Cordis Cypher drug-eluting stent (DES; PEVA/PBMA polymer) and the BX Velocity (no polymer). We quantitatively measured the force required to remove the deflated stent delivery balloon from each of these stents in simulated vessels at 37 degrees C in a water bath. Balloon withdrawal forces were measured in straight (0 degree curve), mildly curved (20 degree curve) and moderately curved (40 degree curve) simulated vessel segments. The average peak force required to remove the deflated balloon catheter from the Taxus Liberté DES, the Liberté BMS, the Cypher DES, and the Bx Velocity BMS were similar in straight segments, but were much greater for the Taxus Liberté in the moderately curved segments (1.4 lbs vs. 0.11 lbs, 0.11 lbs and 0.12 lbs, respectively; p < 0.0001). The SIBS polymer of the Taxus Liberté DES appears to be "sticky" and is associated with high forces required to withdraw the deflated balloon from the deployed stent in curved segments. This withdrawal issue may help to explain the clinical complications that have been reported with this device.

Clinical remission following endoscopic placement of retrievable, fully covered metal stents in patients with esophageal achalasia.

PubMed

Zeng, Y; Dai, Y-M; Wan, X-J

2014-01-01

Metal stents may represent an alternative therapy in the treatment of achalasia. We therefore evaluated the effectiveness of retrievable, fully covered metal stents in patients with achalasia. Fifty-nine patients with achalasia were treated with retrievable, fully covered metal stents. Symptoms using a global symptom score (0-10), lower esophageal sphincter (LES) resting pressure, LES relaxation, and simultaneous contraction of the esophagus were analyzed before and 1 week and 1 month after intervention. Complications and treatment outcomes were followed up at 6, 12, 18, and 24 months postoperatively. Stent placement was successful, and clinical symptoms resolved (P < 0.01) in all patients. Regurgitation, dysphagia and chest pain improved significantly (all P < 0.01). Therapy improved LES resting pressure (51.4 ± 9.7 mmHg pretherapy vs. 20.9 ± 8.1 mmHg post-therapy), LES relaxation (58.1 ± 17.1% pretherapy vs. 84.5 ± 18.9% post-therapy), and simultaneous contraction of the esophagus (36.1 ± 8.6% pretherapy vs. 69.4 ± 23.1% post-therapy) 1 month after stent placement (all P < 0.01). The cumulative clinical remission rates 6, 12, 18, 24, 30, and 36 months after stent removal were 90.9%, 81.8%, 76.4%, 69.1%, 65.5%, and 49.1%, respectively. All patients tolerated stent placement. Twelve patients (25.5%) complained of substernal pain and five (10.6%) had substernal burning. Stents migrated in four patients (8.5%). Insertion of retrievable, fully covered metal stents is an effective and safe treatment in patients with achalasia. © 2013 Wiley Periodicals, Inc. and the International Society for Diseases of the Esophagus.

Temporary endoscopic metallic stent for idiopathic esophageal achalasia.

PubMed

Coppola, Franco; Gaia, Silvia; Rolle, Emanuela; Recchia, Serafino

2014-02-01

Idiopathic achalasia is a motor disorder of the esophagus of unknown etiology caused by loss of motor neurons determining an altered motility. It may determine severe symptoms such as progressive dysphagia, regurgitations, and pulmonary aspirations. Many therapeutic options may be offered to patients with achalasia, from surgery to endoscopic treatments such as pneumatic dilation, botulinum injection, peroral endoscopic myotomy, or endoscopic stenting. Recently, temporary placement of a stent was proposed by Cheng as therapy for achalasia disorders, whereas no Western authors have dealt with it up to date. The present study reports our preliminary experience in 7 patients with achalasia treated with a temporary stent. Partially covered self-expanding metallic stents (Micro-Tech, Nanjin, China) 80 mm long and 30 mm wide were placed under fluoroscopic control and removed after 6 days. Clinical follow-up was scheduled to check endoscopic success, symptoms release, and complications. The placement and the removal of the stents were obtained in all patients without complications. Mean clinical follow-up was 19 months. Five out of 7 patients referred total symptoms release and 2 experienced significant improvement of dysphagia. The procedure was not time consuming and was safe; no mild or severe complications were registered. In conclusion, our results may suggest a possible safe and effective endoscopic alternative treatment in patients with achalasia; however, further larger studies are necessary to confirm these promising, but very preliminary, data.

Role of fully covered self-expandable metal stent for treatment of benign biliary strictures and bile leaks.

PubMed

Pausawasadi, Nonthalee; Soontornmanokul, Tanassanee; Rerknimitr, Rungsun

2012-01-01

Endoscopic therapy by balloon dilation and placement of multiple large-bore plastic stents is the treatment of choice for benign biliary stricture. This approach is effective but it typically requires multiple endoscopic sessions given the short duration of stent patency. The endoscopic approach for treatment of bile leak involves the placement of a stent with or without biliary sphincterotomy. The self-expandable metal stent (SEMS) has traditionally been used for palliation of malignant biliary strictures given the long duration of stent patency owing to their larger stent diameter. Recently, SEMS has been used in a variety of benign biliary strictures and leaks, especially with the design of the covered self-expandable metal stent (CSEMS), which permits endoscopic-mediated stent removal. The use of CSEMS in benign biliary stricture could potentially result in a decrease in endoscopic sessions and it is technically easier when compared to placement of multiple plastic stents. However, complications such as cholecystitis due to blockage of cystic duct, stent migration, infection and pancreatitis have been reported. The potential subsegmental occlusion of contralateral intrahepatic ducts also limits the use of CSEMS in hilar stricture. Certain techniques and improvement of stent design may overcome these challenges in the future. Thus, CSEMS may be appropriate in only highly selected conditions, such as refractory benign biliary stricture, despite multiple plastic stent placement or difficult to treat bile duct stricture from chronic pancreatitis, and should not be used routinely. This review focuses on the use of fully covered self-expandable metal stent for benign biliary strictures and bile leaks.

Role of Fully Covered Self-Expandable Metal Stent for Treatment of Benign Biliary Strictures and Bile Leaks

PubMed Central

Pausawasadi, Nonthalee; Soontornmanokul, Tanassanee

2012-01-01

Endoscopic therapy by balloon dilation and placement of multiple large-bore plastic stents is the treatment of choice for benign biliary stricture. This approach is effective but it typically requires multiple endoscopic sessions given the short duration of stent patency. The endoscopic approach for treatment of bile leak involves the placement of a stent with or without biliary sphincterotomy. The self-expandable metal stent (SEMS) has traditionally been used for palliation of malignant biliary strictures given the long duration of stent patency owing to their larger stent diameter. Recently, SEMS has been used in a variety of benign biliary strictures and leaks, especially with the design of the covered self-expandable metal stent (CSEMS), which permits endoscopic-mediated stent removal. The use of CSEMS in benign biliary stricture could potentially result in a decrease in endoscopic sessions and it is technically easier when compared to placement of multiple plastic stents. However, complications such as cholecystitis due to blockage of cystic duct, stent migration, infection and pancreatitis have been reported. The potential subsegmental occlusion of contralateral intrahepatic ducts also limits the use of CSEMS in hilar stricture. Certain techniques and improvement of stent design may overcome these challenges in the future. Thus, CSEMS may be appropriate in only highly selected conditions, such as refractory benign biliary stricture, despite multiple plastic stent placement or difficult to treat bile duct stricture from chronic pancreatitis, and should not be used routinely. This review focuses on the use of fully covered self-expandable metal stent for benign biliary strictures and bile leaks. PMID:22563290

Biodegradable shape-memory block co-polymers for fast self-expandable stents.

PubMed

Xue, Liang; Dai, Shiyao; Li, Zhi

2010-11-01

Block co-polymers PCTBVs (M(n) of 36,300-65,300 g/mol, T(m) of 39-40 and 142 degrees C) containing hyperbranched three-arm poly(epsilon-caprolactone) (PCL) as switching segment and microbial polyester PHBV as crystallizable hard segment were designed as biodegradable shape-memory polymer (SMP) for fast self-expandable stent and synthesized in 96% yield by the reaction of three-arm PCL-triol (M(n) of 4200 g/mol, T(m) of 47 degrees C) with methylene diphenyl 4,4'-diisocyanate isocynate (MDI) to form the hyperbrached MDI-linked PCL (PTCM; M(n) of 25,400 g/mol and a T(m) of 38 degrees C), followed by further polymerization with PHBV-diol (M(n) of 2200 g/mol, T(m) of 137 and 148 degrees C). The polymers were characterized by (1)H NMR, GPC, DSC, tensile test, and cyclic thermomechanical tensile test. PCTBVs showed desired thermal properties, mechanical properties, and ductile nature. PCTBV containing 25 wt% PHBV (PCTBV-25) demonstrated excellent shape-memory property at 40 degrees C, with R(f) of 94%, R(r) of 98%, and shape recovery within 25s. PCTBV-25 was also shown as a safe material with good biocompatibility by cytotoxicity tests and cell growth experiments. The stent made from PCTBV-25 film showed nearly complete self-expansion at 37 degrees C within only 25 s, which is much better and faster than the best known self-expandable stents. Copyright (c) 2010 Elsevier Ltd. All rights reserved.

[Expandable stents and composite prosthesis].

PubMed

Baldeyrou, P

1999-11-01

Today, numerous expandable and mixed silicone metallic stents for trachea and bronchi are available. Among the many technical propositions, Nitinol is a new alloy with promising potential, offering the advantage of shape memory. The right stent is the one which best meets the needs of the individual stenotic situation as evaluated by endoscopy and CT. Sufficient experience has been acquired only with the Dumon stent, giving exact information about its qualities and possible complications. The new stents are thinner. Some can be inserted under fluoroscopic and fibroscopic control. They are presumed to produce fewer complications an provide answers to some still unresolved questions such as dyskinesia or stenosis on short bronchi. They appear to be more easily inserted on the tracheo-bronchial tree. More experience is needed to satisfactorily identify specific indications and contraindications. A prospective registry will be important to obtain comparative information more quickly.

Novel antireflux covered metal stent for recurrent occlusion of biliary metal stents: a pilot study.

PubMed

Hamada, Tsuyoshi; Isayama, Hiroyuki; Nakai, Yousuke; Kogure, Hirofumi; Togawa, Osamu; Kawakubo, Kazumichi; Yamamoto, Natsuyo; Ito, Yukiko; Sasaki, Takashi; Tsujino, Takeshi; Sasahira, Naoki; Hirano, Kenji; Tada, Minoru; Koike, Kazuhiko

2014-03-01

Feasibility of antireflux metal stent (ARMS), designed to prevent duodenobiliary reflux, was reported in patients with distal malignant biliary obstruction. In this prospective pilot study, we aimed to evaluate a newly designed ARMS as a reintervention for self-expandable metallic stent (SEMS) occlusion believed to be caused by duodenobiliary reflux. Patients with non-resectable distal malignant biliary obstruction were included in whom a prior SEMS was occluded as a result of sludge or food impaction between March 2010 and January 2012 at two Japanese tertiary referral centers. The occluded SEMS were endoscopically removed, if possible, and subsequently replaced by a newly designed ARMS. We evaluated the technical success rate and complications of ARMS and compared the time to occlusion of ARMS with that of prior SEMS. A total of 13 patients were included. ARMS was successfully placed in all patients in a single procedure. No procedure-related complications were identified. ARMS occlusion occurred in two patients (15%), the causes of which were sludge in one patient and unknown in the other. ARMS migration occurred in four patients (31%). ARMS patency time was significantly longer than that of prior SEMS (median, not available vs 58 days; P = 0.039). This newly designed ARMS is a technically feasible, safe, and effective reintervention for SEMS occlusion as a result of sludge or food impaction. An anti-migration mechanism to improve the outcomes of ARMS should be considered. © 2013 The Authors. Digestive Endoscopy © 2013 Japan Gastroenterological Endoscopy Society.

Endoscopic removal of malfunctioning biliary self-expandable metallic stents.

PubMed

Familiari, Pietro; Bulajic, Milutin; Mutignani, Massimiliano; Lee, Linda S; Spera, Gianluca; Spada, Cristiano; Tringali, Andrea; Costamagna, Guido

2005-12-01

Endoscopic removal of malfunctioning self-expandable metallic biliary stents (SEMS) is difficult and not well described. The aim of this study is to review the indications, the techniques, and the results of SEMS removal in a cohort of patients with malfunctioning stents. All patients who underwent an attempt at endoscopic removal of biliary SEMS over a 5-year period were retrospectively identified. The main indications for SEMS removal were the following: distal migration of the stent or impaction to the duodenum, impaction into the bile-duct wall, tissue ingrowth, and inappropriate length of the stent causing occlusion of intrahepatic ducts. SEMS were removed by using foreign-body forceps or polypectomy snares. Endoscopic removal of 39 SEMS (13 uncovered and 26 covered) was attempted in 29 patients (17 men; mean age, 66 years). SEMS extraction was attempted after a mean of 7.5 months (8.75 months standard deviation) post-SEMS insertion. Removal was successful in 20 patients (68.9%) and in 29 SEMS (74.3%). Covered SEMS were effectively removed more frequently than uncovered ones: 24 of 26 (92.3%) and 5 of 13 (38.4%), respectively (p < 0.05). No major complications were recorded. Multivariate analysis showed that the time interval between insertion and removal, SEMS length, stent-mesh design (zigzag vs. interlaced), and indication for removal were not predictive of success at stent removal. Endoscopic removal of biliary SEMS is feasible and safe in more than 70% of cases. Because only 38% of uncovered SEMS were removable, the presence of a stent covering is the only factor predictive of successful stent extraction. The presence of diffuse and severe ingrowth was the main feature limiting SEMS removal.

The biodurability of covering materials for metallic stents in a bile flow phantom.

PubMed

Bang, Byoung Wook; Jeong, Seok; Lee, Don Haeng; Lee, Jung Il; Lee, Se Chul; Kang, Sung-Gwon

2012-04-01

Covered biliary metal stents have been introduced for the purpose of overcoming tumor ingrowth and treatment of benign biliary stricture. The aim of this study was to evaluate the biodurability of three commercially available biliary metal stent covering materials [e-PTFE (expanded polytetrafluoroethylene), silicone, and polyurethane] in a bile flow phantom. By operation of a peristaltic pump, human bile was circulated continuously in an experimental perfusion system containing covered metal stents. Each stent was removed, respectively, 1, 2, 4, and 6 months after bile exposure. We performed a gross inspection of the covered stents. The covering membrane was detached from the stent and observed by scanning electron microscopy (SEM). Finally, we measured tensile and tear strength of the membranes. Bile-staining of the membrane showed gradual progression after bile exposure; however, progress was the fastest in e-PTFE. SEM examination showed that the polyurethane surface was smooth, and the silicone surface was relatively smooth. However, e-PTFE had a rough and uneven surface. After bile exposure, there were no significant changes in polyurethane and silicone; however, biofilms and microcracks were observed in e-PTFE. In contrast to a gradual decrease of tensile/tear strength of polyurethane and silicone, those of e-PTFE showed a rapid reduction despite of the strongest baseline tensile and tear strength. e-PTFE tended to form biofilms more frequently than polyurethane and silicone during bile exposure. e-PTFE seemed to be less durable than silicone and polyurethane, however, as clinically applicable material because of strong absolute tensile/tear strengths.

Delayed Esophageal Hemorrhage Caused by a Metal Stent: Treatment with Embolization

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kos, Xavier; Trotteur, Genevieve; Dondelinger, Robert F.

We report a case of life-threatening esophageal hemorrhage after metal stent implantation successfully treated by arterial embolization. An 85-year-old woman was admitted in shock secondary to massive hematemesis and melena. Recent medical history revealed esophageal cancer treated 8 weeks previously by endoesophageal radiotherapy (40 Gy) and endoscopic placement of a covered Wallstent prosthesis. Selective arteriography of the fifth posterior right intercostal artery showed massive contrast extravasation in the esophagus. Embolization was performed with 150-250-{mu}m polyvinyl alcohol particles. Follow-up at 5 months was uneventful. Arteriography and embolization are advised when severe hemorrhage occurs after esophageal implantation of metal stents.

Endoscopic removal and trimming of distal self-expandable metallic biliary stents

PubMed Central

Ishii, Kentaro; Itoi, Takao; Sofuni, Atsushi; Itokawa, Fumihide; Tsuchiya, Takayoshi; Kurihara, Toshio; Tsuji, Shujiro; Ikeuchi, Nobuhito; Umeda, Junko; Moriyasu, Fuminori; Tsuchida, Akihiko

2011-01-01

AIM: To evaluate the efficacy and safety of endoscopic removal and trimming of self-expandable metallic stents (SEMS). METHODS: All SEMS had been placed for distal biliary strictures. Twenty-seven endoscopic procedures were performed in 19 patients in whom SEMS (one uncovered and 18 covered) removal had been attempted, and 8 patients in whom stent trimming using argon plasma coagulation (APC) had been attempted at Tokyo Medical University Hospital. The APC settings were: voltage 60-80 W and gas flow at 1.5 L/min. RESULTS: The mean stent indwelling period for all patients in whom stent removal had been attempted was 113.7 ± 77.6 d (range, 8-280 d). Of the 19 patients in whom removal of the SEMS had been attempted, the procedure was successful in 14 (73.7%) without procedure-related adverse events. The indwelling period in the stent removable group was shorter than that in the unremovable group (94.9 ± 71.5 d vs 166.2 ± 76.2 d, P = 0.08). Stent trimming was successful for all patients with one minor adverse event consisting of self-limited hemorrhage. Trimming time ranged from 11 to 16 min. CONCLUSION: Although further investigations on larger numbers of cases are necessary to accumulate evidence, the present data suggested that stent removal and stent trimming is feasible and effective for stent-related complications. PMID:21677835

Multi-stage surgery for airway patency after metallic stent removal in benign laryngotracheal airway disease in two adolescents.

PubMed

Coordes, Annekatrin; Todt, Ingo; Ernst, Arne; Seidl, Rainer O

2013-05-01

Laryngotracheal stents may damage the highly complex laryngeal structures, impair voice and swallowing functions and cause tissue ingrowths, thereby necessitating airway patency interventions. In benign airway disease, the number of adolescents with laryngotracheal stents is therefore limited. We present two cases of laryngeal metallic stent placement following benign airway disease. Two adolescents presented with severe dyspnea and self-expandable metallic stent placement after benign laryngotracheal stenoses. Granulation tissue ingrowths required additional surgical interventions every 6-8 weeks to recanalize the stent lumen. We performed multi-stage surgery including removal of the embedded stent, segmental resection of the stenotic area, end-to-end-anastomosis and laryngotracheal reconstruction respectively, to achieve patent airway without tracheal cannulation. Montgomery T-tubes were temporarily inserted to bridge the complex reconstructions. In both adolescents, we achieved successful removal of the embedded stent and patent airway. Bilateral vocal fold paralysis required additional surgery to improve the final airway patency and vocal rehabilitation. Stent removal, segmental resection and laryngotracheal reconstruction provide the achievement of patent airway and allow decannulation. Temporary Montgomery T-tubes bridge complex laryngotracheal reconstructions. In benign laryngeal airway disease, stent placement should be avoided, especially in adolescents. Transfer to a specialist center should be considered prior to metallic stent implantation. In general, self-expanding tracheobronchial stents can be placed in selected patients where surgical interventions are limited. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Self-expandable metal stents for malignant colonic obstruction: data from a retrospective regional SIED-AIGO study.

PubMed

Di Mitri, Roberto; Mocciaro, Filippo; Traina, Mario; Montalbano, Luigi Maria; Familiari, Luigi; D'Amore, Fabio; Raimondo, Dario; Virgilio, Clara; Tarantino, Ilaria; Barresi, Luca; Giunta, Marco; Borina, Eleonora; Borruto, Antonino; Marino, Antonino

2014-03-01

Self-expandable metal stents are a non-surgical option for the treatment of symptomatic malignant colorectal obstruction as palliative treatment or as a bridge to surgery. To report data from a regional study on self-expandable metal stent (SEMS) placement for malignant colorectal obstruction. Two hundred and four patients (male 54.9%, mean age of 69.5 ± 14.2) were retrospectively evaluated and data on technical and clinical success, and complications, were analyzed. Technical and clinical success rates were 99% and 94.6% respectively, with 36.7% treated on an emergency basis and 63.3% electively. Palliative treatment was administered to 70.1%, and as a bridge to surgery for 29.9%. Complications were 17 neoplastic ingrowths, 10 stent migrations, and 4 perforations. Palliative treatment was associated with a higher risk of stent ingrowth (p=0.003), and chemotherapy with a lower risk of stent ingrowth (p=0.009). This regional study, although it has certain limitations, confirms the positive role of self-expandable metal stents in the treatment of symptomatic malignant colorectal obstruction, and that chemotherapy decreases the risk of ingrowth. Copyright © 2013 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

Evaluation of anti-migration properties of biliary covered self-expandable metal stents

PubMed Central

Minaga, Kosuke; Kitano, Masayuki; Imai, Hajime; Harwani, Yogesh; Yamao, Kentaro; Kamata, Ken; Miyata, Takeshi; Omoto, Shunsuke; Kadosaka, Kumpei; Sakurai, Toshiharu; Nishida, Naoshi; Kudo, Masatoshi

2016-01-01

AIM: To assess anti-migration potential of six biliary covered self-expandable metal stents (C-SEMSs) by using a newly designed phantom model. METHODS: In the phantom model, the stent was placed in differently sized holes in a silicone wall and retracted with a retraction robot. Resistance force to migration (RFM) was measured by a force gauge on the stent end. Radial force (RF) was measured with a RF measurement machine. Measured flare structure variables were the outer diameter, height, and taper angle of the flare (ODF, HF, and TAF, respectively). Correlations between RFM and RF or flare variables were analyzed using a linear correlated model. RESULTS: Out of the six stents, five stents were braided, the other was laser-cut. The RF and RFM of each stent were expressed as the average of five replicate measurements. For all six stents, RFM and RF decreased as the hole diameter increased. For all six stents, RFM and RF correlated strongly when the stent had not fully expanded. This correlation was not observed in the five braided stents excluding the laser cut stent. For all six stents, there was a strong correlation between RFM and TAF when the stent fully expanded. For the five braided stents, RFM after full stent expansion correlated strongly with all three stent flare structure variables (ODF, HF, and TAF). The laser-cut C-SEMS had higher RFMs than the braided C-SEMSs regardless of expansion state. CONCLUSION: RF was an important anti-migration property when the C-SEMS did not fully expand. Once fully expanded, stent flare structure variables plays an important role in anti-migration. PMID:27570427

Evaluation of anti-migration properties of biliary covered self-expandable metal stents.

PubMed

Minaga, Kosuke; Kitano, Masayuki; Imai, Hajime; Harwani, Yogesh; Yamao, Kentaro; Kamata, Ken; Miyata, Takeshi; Omoto, Shunsuke; Kadosaka, Kumpei; Sakurai, Toshiharu; Nishida, Naoshi; Kudo, Masatoshi

2016-08-14

To assess anti-migration potential of six biliary covered self-expandable metal stents (C-SEMSs) by using a newly designed phantom model. In the phantom model, the stent was placed in differently sized holes in a silicone wall and retracted with a retraction robot. Resistance force to migration (RFM) was measured by a force gauge on the stent end. Radial force (RF) was measured with a RF measurement machine. Measured flare structure variables were the outer diameter, height, and taper angle of the flare (ODF, HF, and TAF, respectively). Correlations between RFM and RF or flare variables were analyzed using a linear correlated model. Out of the six stents, five stents were braided, the other was laser-cut. The RF and RFM of each stent were expressed as the average of five replicate measurements. For all six stents, RFM and RF decreased as the hole diameter increased. For all six stents, RFM and RF correlated strongly when the stent had not fully expanded. This correlation was not observed in the five braided stents excluding the laser cut stent. For all six stents, there was a strong correlation between RFM and TAF when the stent fully expanded. For the five braided stents, RFM after full stent expansion correlated strongly with all three stent flare structure variables (ODF, HF, and TAF). The laser-cut C-SEMS had higher RFMs than the braided C-SEMSs regardless of expansion state. RF was an important anti-migration property when the C-SEMS did not fully expand. Once fully expanded, stent flare structure variables plays an important role in anti-migration.

Plastic or metal stents for benign extrahepatic biliary strictures: a systematic review

PubMed Central

2009-01-01

Background Benign biliary strictures may be a consequence of surgical procedures, chronic pancreatitis or iatrogenic injuries to the ampulla. Stents are increasingly being used for this indication, however it is not completely clear which stent type should be preferred. Methods A systematic review on stent placement for benign extrahepatic biliary strictures was performed after searching PubMed and EMBASE databases. Data were pooled and evaluated for technical success, clinical success and complications. Results In total, 47 studies (1116 patients) on outcome of stent placement were identified. No randomized controlled trials (RCTs), one non-randomized comparative studies and 46 case series were found. Technical success was 98,9% for uncovered self-expandable metal stents (uSEMS), 94,8% for single plastic stents and 94,0% for multiple plastic stents. Overall clinical success rate was highest for placement of multiple plastic stents (94,3%) followed by uSEMS (79,5%) and single plastic stents (59.6%). Complications occurred more frequently with uSEMS (39.5%) compared with single plastic stents (36.0%) and multiple plastic stents (20,3%). Conclusion Based on clinical success and risk of complications, placement of multiple plastic stents is currently the best choice. The evolving role of cSEMS placement as a more patient friendly and cost effective treatment for benign biliary strictures needs further elucidation. There is a need for RCTs comparing different stent types for this indication. PMID:20017920

Everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting metallic stents: a meta-analysis of randomised controlled trials.

PubMed

Cassese, Salvatore; Byrne, Robert A; Ndrepepa, Gjin; Kufner, Sebastian; Wiebe, Jens; Repp, Janika; Schunkert, Heribert; Fusaro, Massimiliano; Kimura, Takeshi; Kastrati, Adnan

2016-02-06

Bioresorbable coronary stents might improve outcomes of patients treated with percutaneous coronary interventions. The everolimus-eluting bioresorbable vascular scaffold is the most studied of these stent platforms; however, its performance versus everolimus-eluting metallic stents remains poorly defined. We aimed to assess the efficacy and safety of everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting metallic stents in patients with ischaemic heart disease treated with percutaneous revascularisation. We searched Medline, Embase, the Cochrane Central Register of Controlled Trials (CENTRAL), scientific sessions abstracts, and relevant websites for randomised trials investigating everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting metallic stents published or posted between Nov 30, 2006, and Oct 12, 2015. The primary efficacy outcome was target lesion revascularisation and the primary safety outcome was definite or probable stent (scaffold) thrombosis. Secondary outcomes were target lesion failure (the composite of cardiac death, target-vessel myocardial infarction, or ischaemia-driven target lesion revascularisation), myocardial infarction, death, and in-device late lumen loss. We derived odds ratios (ORs) and weighted mean differences with 95% CIs, and calculated the risk estimates for the main outcomes according to a random-effects model. This study is registered with PROSPERO, number CRD42015026374. We included six trials, comprising data for 3738 patients randomised to receive percutaneous coronary intervention with either an everolimus-eluting bioresorbable vascular scaffold (n=2337) or an everolimus-eluting metallic stent (n=1401). Median follow-up was 12 months (IQR 9-12). Patients treated with bioresorbable vascular scaffolds had a similar risk of target lesion revascularisation (OR 0.97 [95% CI 0.66-1.43]; p=0.87), target lesion failure (1.20 [0.90-1.60]; p=0.21), myocardial infarction (1.36 [0.98-1.89]; p

A novel endobronchial approach to massive hemoptysis complicating silicone Y-stent placement for tracheobronchomalacia: A case report.

PubMed

Ryu, Changwan; Boffa, Daniel; Bramley, Kyle; Pisani, Margaret; Puchalski, Jonathan

2018-02-01

Airway stabilization for severe, symptomatic tracheobronchomalacia (TBM) may be accomplished by silicone Y-stent placement. Common complications of the Y-stent include mucus plugging and granulation tissue formation. We describe a rare case of massive hemoptysis originating from a silicone Y-stent placed for TBM. An emergent bronchoscopy showed an actively bleeding, pulsatile vessel at the distal end of the left bronchial limb of the Y-stent. It was felt that the bleeding was caused by, or at least impacted by, the distal left bronchial limb of the Y-stent eroding into the airway wall. We hypothesized that placement of oxidized regenerated cellulose (ORC) would provide initial hemostasis, and the subsequent placement of a biocompatible surgical sealant would lead to definitive resolution. ORC provided sufficient hemostasis and the subsequent synthetic polymer reinforced the tissue for complete cessation of the bleed. The combined use of ORC and a biocompatible surgical sealant provided long-term management for life-threatening hemoptysis, and potentially morbid procedures such as embolization or surgery were avoided by advanced endobronchial therapy.

A new fully covered metal stent for the treatment of benign and malignant dysphagia: a prospective follow-up study.

PubMed

Hirdes, Meike M C; Siersema, Peter D; Vleggaar, Frank P

2012-04-01

Fully covered self-expandable metal stents (FCSEMSs) are increasingly being used for malignant and benign strictures. Particularly in the latter, FCSEMSs are known for their high migration rates. A new FCSEMS with a dog-bone shape and internal covering was developed to reduce migration risk. To evaluate recurrent dysphagia and safety of the new FC stent in benign and malignant esophageal disorders. Prospective follow-up study. Tertiary referral center. Between November 2009 and February 2011, 48 consecutive patients (mean age 61 years, range 28-81 years) underwent FC stent placement for malignant (n = 33) or benign (n = 15) dysphagia. FC stent placement. Recurrent dysphagia and complications. Indications for FC stent placement included esophageal cancer (n = 28), extrinsic malignant compression (n = 4), recurrent malignancy after esophagectomy (n = 1), and refractory benign esophageal stricture (n = 15). In malignant strictures, recurrent dysphagia occurred in 5 patients (15%) because of stent migration (n = 3), tissue overgrowth (n = 1), and acute edema (n = 1). In benign strictures, stents were prematurely removed in 9 (60%) patients because of stent migration (n = 5), tissue overgrowth (n = 3), and pain (n = 1). Recurrent dysphagia occurred in all patients after stent removal. Major complications occurred in 10 patients (30%) with malignant strictures and in 3 patients (20%) with benign strictures and included severe pain and/or vomiting (n = 8), fistula formation (n = 2), bleeding (n = 2), and aspiration pneumonia (n = 1). Nonrandomized study design. Although the new FC stent effectively treats malignant dysphagia, it is associated with substantial major complications. In patients with refractory benign esophageal strictures, recurrent dysphagia occurs rapidly after removal of the new FC stent. Copyright © 2012 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

Long-term outcomes of a newly developed hybrid metal stent for EUS-guided biliary drainage (with videos).

PubMed

Cho, Dong Hui; Lee, Sang Soo; Oh, Dongwook; Song, Tae Jun; Park, Do Hyun; Seo, Dong Wan; Lee, Sung Koo; Kim, Myung-Hwan

2017-05-01

Although fully covered self-expandable metal stents (FCSEMSs) have been commonly used for EUS-guided biliary drainage (EUS-BD), FCSEMS migration is a main limitation of this procedure. In the present study we evaluated the technical and clinical success rates, adverse events, and long-term outcomes of a newly developed hybrid stent that has been customized for EUS-BD. From September 2011 to May 2015, 54 consecutive patients with biliary obstruction were enrolled in this prospective, observational study. These patients were candidates for alternative BD techniques because of failed ERCP. The hybrid metal stent used for EUS-BD in this study was partially covered, had anchoring flaps, and is commercially available in Korea. EUS-guided hepaticogastrostomy (EUS-HGS) was performed in 21 patients and EUS-guided choledochoduodenostomy (EUS-CDS) in 33 patients. The technical and clinical success rates of EUS-BD were 100% (54/54) and 94.4% (51/54), respectively. Immediate adverse events developed after EUS-BD in 9 patients (16.6%; cholangitis in 3, bleeding in 2, self-limited pneumoperitoneum in 3, and abdominal pain in 1). Proximal or distal stent migration was not observed during the follow-up period (median, 148.5 days; IQR, 79.7-244), and the mean stent patency duration was 166.3 days and 329.1 days in the EUS-HGS and EUS-CDS groups, respectively. EUS-BD with the hybrid metal stent is technically feasible and can effectively treat biliary obstruction after failed ERCP. EUS-BD with the hybrid metal stent can reduce stent-related adverse events, especially stent migration. Copyright © 2017 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

Outcomes of second self-expandable metallic stent insertion for malignant gastric outlet obstruction.

PubMed

Kim, Chan Gyoo; Choi, Il Ju; Lee, Jong Yeul; Cho, Soo-Jeong; Kim, Soo Jin; Kim, Mi-Jung; Park, Sook Ryun; Park, Young Lee

2014-01-01

Self-expandable metallic stents are used widely to relieve malignant gastric outlet obstruction (GOO). However, restenosis or migration of first stents is a frequent complication. The purpose of this retrospective cohort study was to evaluate the effectiveness of second stents as an approach to manage failure of first stents in patients with malignant GOO. A total of 222 patients with gastric cancer received first stents due to inoperable GOO at National Cancer Center in Korea between January 2008 and June 2011. Monthly follow-up interviews were performed, and second stents (stent-in-stent or stent-after-migration) were inserted in 59 patients by June 2012. Technical and clinical successes and long-term complications were evaluated. The technical and immediate clinical success rates were 98.3 % (58/59) and 91.5 % (54/59), respectively. Patients who received a second stent due to late complications involving the first stent (migration, restenosis, and fracture) showed a higher clinical success rate (95.8 % [46/48]) than patients who received a second stent due to immediate clinical failure of the first stent (72.7 % [8/11], p = 0.04). The immediate clinical success rate of stent-after-migration (100 % [11/11]) was not different from that of stent-in-stent (89.6 % [43/48], p = 1.0). The stent dysfunction rate of stent-after-migration (27.3 % [3/11]) also was similar to that of stent-in-stent (29.2 % [14/48], p = 1.0). The median patencies of stent-in-stent and stent-after-migration were 27.4 and 58.4 weeks, respectively (p = 0.177). There were no significant prognostic factors for patency of second stents. Insertion of a second stent is effective for treating the first-stent failure in gastric cancer patients with GOO, especially if the immediate outcome of the first stent was successful.

Evaluation of a fully covered self-expanding metal stent with flared ends in malignant biliary obstruction: a multicenter study.

PubMed

Kahaleh, Michel; Talreja, Jayant P; Loren, David E; Kowalski, Thomas E; Poneros, John M; Degaetani, Marisa; Raijman, Isaac; Sejpal, Divyesh V; Patel, Sandeep; Rosenkranz, Lauren; McNamara, Kevin N; Brijbassie, Alan; Wang, Andrew Y; Gaidhane, Monica; Sethi, Amrita; Stevens, Peter D

2013-01-01

Limited data are available regarding fully covered metal stents in the management of malignant distal biliary strictures. The aim of this study was to evaluate the safety of a fully covered self-expanding metal stent (FCSEMS) with flared ends, in treating malignant biliary strictures. We report our long-term retrospective analysis from 6 centers. A total of 260 patients (142 males, median age 68 y) underwent endoscopic retrograde cholangiopancreatography with placement of FCSEMS (WallFlex; Boston Scientific, Natick, MA) for the palliation of obstructive jaundice in the setting of pancreatic adenocarcinoma (169), metastatic disease (36), cholangiocarcinoma (23), ampullary cancer (19), or other (13). Patients were evaluated clinically in follow-up and biochemical tests of liver function were obtained. Data were recorded for the following variables: patient survival, duration of stent patency, the need for subsequent biliary intervention, and complications. A total of 266 FCSEMS were placed in 260 patients. There was a median survival of 100 days (range, 7 to 531 d). There was a mean follow-up of 134±118 days (range, 4 to 519 d). Biliary decompression was successful in 252 patients (97%). At the end of the study period, 121 were alive with a patent stent, 65 patients died with a patent stent, 40 patients were successfully bridged to surgery, 8 patients had their patent stent removed and had no need for further stenting, and 18 patients were lost to follow-up. Five patients who had a successfully placed FCSEMS were considered a failure due to the following reason: migration (2), cholangitis (1), stent occlusion (1), and removal for management of proximal biliary obstruction (1). Two additional patients experienced migration that did not require FCSEMS removal or replacement. Stent replacement was required in 10 patients, of whom 6 had a second FCSEMS placed. The remaining 4 were in the failure group and underwent replacement with either uncovered stents or plastic

Fully covered self-expanding metal stents versus lumen-apposing fully covered self-expanding metal stent versus plastic stents for endoscopic drainage of pancreatic walled-off necrosis: clinical outcomes and success.

PubMed

Siddiqui, Ali A; Kowalski, Thomas E; Loren, David E; Khalid, Ammara; Soomro, Ayesha; Mazhar, Syed M; Isby, Laura; Kahaleh, Michel; Karia, Kunal; Yoo, Joseph; Ofosu, Andrew; Ng, Beverly; Sharaiha, Reem Z

2017-04-01

Endoscopic transmural drainage/debridement of pancreatic walled-off necrosis (WON) has been performed using double-pigtail plastic (DP), fully covered self-expanding metal stents (FCSEMSs), or the novel lumen-apposing fully covered self-expanding metal stent (LAMS). Our aim was to perform a retrospective cohort study to compare the clinical outcomes and adverse events of EUS-guided drainage/debridement of WON with DP stents, FCSEMSs, and LAMSs. Consecutive patients in 2 centers with WON managed by EUS-guided debridement were divided into 3 groups: (1) those who underwent debridement using DP stents, (2) debridement using FCSEMSs, (3) debridement using LAMSs. Technical success (ability to access and drain a WON by placement of transmural stents), early adverse events, number of procedures performed per patient to achieve WON resolution, and long-term success (complete resolution of the WON without need for further reintervention at 6 months after treatment) were evaluated. From 2010 to 2015, 313 patients (23.3% female; mean age, 53 years) underwent WON debridement, including 106 who were drained using DP stents, 121 using FCSEMSs, and 86 using LAMSs. The 3 groups were matched for age, cause of the pancreatitis, WON size, and location. The cause of the patients' pancreatitis was gallstones (40.6%), alcohol (30.7%), idiopathic (13.1%), and other causes (15.6%). The mean cyst size was 102 mm (range, 20-510 mm). The mean number of endoscopy sessions was 2.5 (range, 1-13). The technical success rate of stent placement was 99%. Early adverse events were noted in 27 of 313 (8.6%) patients (perforation in 6, bleeding in 8, suprainfection in 9, other in 7). Successful endoscopic therapy was noted in 277 of 313 (89.6%) patients. When comparing the 3 groups, there was no difference in the technical success (P = .37). Early adverse events were significantly lower in the FCSEMS group compared with the DP and LAMS groups (1.6%, 7.5%, and 9.3%; P < .01). At 6-month follow

Percutaneous intraductal radiofrequency ablation for clearance of occluded metal stent in malignant biliary obstruction: feasibility and early results.

PubMed

Pai, Madhava; Valek, Vlastimil; Tomas, Andrasina; Doros, Attila; Quaretti, Pietro; Golfieri, Rita; Mosconi, Cristina; Habib, Nagy

2014-02-01

The major complication occurring with biliary stents is stent occlusion, frequently seen because of tumour in-growth, epithelial hyperplasia, and sludge deposits, resulting in recurrent jaundice and cholangitis. We report a prospective study with the results of first in man percutaneous intraductal radiofrequency (RF) ablation to clear the blocked metal stents in patients with malignant biliary obstruction using a novel bipolar RF catheter. Nine patients with malignant biliary obstruction and blocked metal stents were included. These patients underwent intraductal biliary RF ablation through the blocked metal stent following external biliary decompression with an internal-external biliary drainage. All nine patients had their stent patency restored successfully without the use of secondary stents. Following this intervention, there was no 30-day mortality, haemorrhage, bile duct perforation, bile leak, or pancreatitis. Of the nine patients, six are alive and three patients are dead with a median follow-up of 122 (range 50-488) days and a median stent patency of 102.5 (range 50-321) days. Six patients had their stent patent at the time of last follow-up or death. Three patients with stent blockage at 321, 290, and 65 days postprocedure underwent percutaneous transhepatic drain insertion and repeat ablation. In this selective group of patients, it appears that this new approach is safe and feasible. Efficacy remains to be proven in future, randomized, prospective studies.

Clinical evaluation of radiotherapy for advanced esophageal cancer after metallic stent placement

PubMed Central

Yu, You-Tao; Yang, Guang; Liu, Yan; Shen, Bao-Zhong

2004-01-01

AIM: To evaluate the therapeutic effect of radiotherapy for esophageal cancer after expandable metallic stent placement. METHODS: Ten cases of advanced esophageal cancer were evaluated, 7 having complete obstruction and 3 with digestive-respiratory fistula. Ten nitinol stents were placed at the site of stenosis. Patients were treated with a total dose of 1200 cGy divided into 3 fractions of 400 cGy 4-7 d after stents placement. RESULTS: All the 10 stents were placed successfully at one time. After radiotherapy for advanced esophageal cancer, the survival period of the cases ranged from 14 to 22 mo, with a mean survival of 17 mo. No re-stenosis occurred among all the 10 cases. CONCLUSION: Stent placement combined with radiotherapy for esophageal cancer is helpful to prolong patients’ survival and reduce occurrence of re-stenosis. PMID:15237455

Biodegradable-polymer drug-eluting stents vs. bare metal stents vs. durable-polymer drug-eluting stents: a systematic review and Bayesian approach network meta-analysis.

PubMed

Kang, Si-Hyuck; Park, Kyung Woo; Kang, Do-Yoon; Lim, Woo-Hyun; Park, Kyung Taek; Han, Jung-Kyu; Kang, Hyun-Jae; Koo, Bon-Kwon; Oh, Byung-Hee; Park, Young-Bae; Kandzari, David E; Cohen, David J; Hwang, Seung-Sik; Kim, Hyo-Soo

2014-05-01

The aim of this study was to compare the safety and efficacy of biodegradable-polymer (BP) drug-eluting stents (DES), bare metal stents (BMS), and durable-polymer DES in patients undergoing coronary revascularization, we performed a systematic review and network meta-analysis using a Bayesian framework. Study stents included BMS, paclitaxel-eluting (PES), sirolimus-eluting (SES), endeavor zotarolimus-eluting (ZES-E), cobalt-chromium everolimus-eluting (CoCr-EES), platinium-chromium everolimus-eluting (PtCr-EES), resolute zotarolimus-eluting (ZES-R), and BP biolimus-eluting stents (BP-BES). After a systematic electronic search, 113 trials with 90 584 patients were selected. The principal endpoint was definite or probable stent thrombosis (ST) defined according to the Academic Research Consortium within 1 year. Biodegradable polymer-biolimus-eluting stents [OR, 0.56; 95% credible interval (CrI), 0.33-0.90], SES (OR, 0.53; 95% CrI, 0.38-0.73), CoCr-EES (OR, 0.34; 95% CrI, 0.23-0.52), and PtCr-EES (OR, 0.31; 95% CrI, 0.10-0.90) were all superior to BMS in terms of definite or probable ST within 1 year. Cobalt-chromium everolimus-eluting stents demonstrated the lowest risk of ST of all stents at all times after stent implantation. Biodegradable polymer-biolimus-eluting stents was associated with a higher risk of definite or probable ST than CoCr-EES (OR, 1.72; 95% CrI, 1.04-2.98). All DES reduced the need for repeat revascularization, and all but PES reduced the risk of myocardial infarction compared with BMS. All DESs but PES and ZES-E were superior to BMS in terms of ST within 1 year. Cobalt-chromium everolimus-eluting stents was safer than any DES even including BP-BES. Our results suggest that not only the biodegradability of polymer, but the optimal combination of stent alloy, design, strut thickness, polymer, and drug all combined determine the safety of DES.

Fully covered self-expandable metal stents (SEMS), partially covered SEMS and self-expandable plastic stents for the treatment of benign esophageal ruptures and anastomotic leaks.

PubMed

van Boeckel, Petra G A; Dua, Kulwinder S; Weusten, Bas L A M; Schmits, Ruben J H; Surapaneni, Naveen; Timmer, Robin; Vleggaar, Frank P; Siersema, Peter D

2012-02-29

Benign esophageal ruptures and anastomotic leaks are life-threatening conditions that are often treated surgically. Recently, placement of partially and fully covered metal or plastic stents has emerged as a minimally invasive treatment option. We aimed to determine the clinical effectiveness of covered stent placement for the treatment of esophageal ruptures and anastomotic leaks with special emphasis on different stent designs. Consecutive patients who underwent placement of a fully covered self-expandable metal stent (FSEMS), a partially covered SEMS (PSEMS) or a self-expanding plastic stent (SEPS) for a benign esophageal rupture or anastomotic leak after upper gastrointestinal surgery in the period 2007-2010 were included. Data on patient demographics, type of lesion, stent placement and removal, clinical success and complications were collected A total of 52 patients received 83 esophageal stents (61 PSEMS, 15 FSEMS, 7 SEPS) for an anastomotic leak (n=32), iatrogenic rupture (n=13), Boerhaave's syndrome (n=4) or other cause (n=3). Endoscopic stent removal was successful in all but eight patients treated with a PSEMS due to tissue ingrowth. Clinical success was achieved in 34 (76%, intention-to-treat: 65%) patients (PSEMS: 73%, FSEMS: 83%, SEPS: 83%) after a median of 1 (range 1-5) stent and a median stenting time of 39 (range 7-120) days. In total, 33 complications in 24 (46%) patients occurred (tissue in- or overgrowth (n=8), stent migration (n=10), ruptured stent cover (all Ultraflex; n=6), food obstruction (n=3), severe pain (n=2), esophageal rupture (n=2), hemorrhage (n=2)). One (2%) patient died of a stent-related cause. Covered stents placed for a period of 5-6 weeks may well be an alternative to surgery for treating benign esophageal ruptures or anastomotic leaks. As efficacy between PSEMS, FSEMS and SEPS is not different, stent choice should depend on expected risks of stent migration (SEPS and FSEMS) and tissue in- or overgrowth (PSEMS).

Fully covered self-expandable metal stents (SEMS), partially covered SEMS and self-expandable plastic stents for the treatment of benign esophageal ruptures and anastomotic leaks

PubMed Central

2012-01-01

Background Benign esophageal ruptures and anastomotic leaks are life-threatening conditions that are often treated surgically. Recently, placement of partially and fully covered metal or plastic stents has emerged as a minimally invasive treatment option. We aimed to determine the clinical effectiveness of covered stent placement for the treatment of esophageal ruptures and anastomotic leaks with special emphasis on different stent designs. Methods Consecutive patients who underwent placement of a fully covered self-expandable metal stent (FSEMS), a partially covered SEMS (PSEMS) or a self-expanding plastic stent (SEPS) for a benign esophageal rupture or anastomotic leak after upper gastrointestinal surgery in the period 2007-2010 were included. Data on patient demographics, type of lesion, stent placement and removal, clinical success and complications were collected Results A total of 52 patients received 83 esophageal stents (61 PSEMS, 15 FSEMS, 7 SEPS) for an anastomotic leak (n = 32), iatrogenic rupture (n = 13), Boerhaave's syndrome (n = 4) or other cause (n = 3). Endoscopic stent removal was successful in all but eight patients treated with a PSEMS due to tissue ingrowth. Clinical success was achieved in 34 (76%, intention-to-treat: 65%) patients (PSEMS: 73%, FSEMS: 83%, SEPS: 83%) after a median of 1 (range 1-5) stent and a median stenting time of 39 (range 7-120) days. In total, 33 complications in 24 (46%) patients occurred (tissue in- or overgrowth (n = 8), stent migration (n = 10), ruptured stent cover (all Ultraflex; n = 6), food obstruction (n = 3), severe pain (n = 2), esophageal rupture (n = 2), hemorrhage (n = 2)). One (2%) patient died of a stent-related cause. Conclusions Covered stents placed for a period of 5-6 weeks may well be an alternative to surgery for treating benign esophageal ruptures or anastomotic leaks. As efficacy between PSEMS, FSEMS and SEPS is not different, stent choice should depend on expected risks of stent migration (SEPS

Long-Term Results of Everolimus-Eluting Stents Versus Drug-Eluting Balloons in Patients With Bare-Metal In-Stent Restenosis: 3-Year Follow-Up of the RIBS V Clinical Trial.

PubMed

Alfonso, Fernando; Pérez-Vizcayno, María José; García Del Blanco, Bruno; Otaegui, Imanol; Masotti, Mónica; Zueco, Javier; Veláquez, Maite; Sanchís, Juan; García-Touchard, Arturo; Lázaro-García, Rosa; Moreu, José; Bethencourt, Armando; Cuesta, Javier; Rivero, Fernando; Cárdenas, Alberto; Gonzalo, Nieves; Jiménez-Quevedo, Pilar; Fernández, Cristina

2016-06-27

The aim of this study was to compare the long-term efficacy of everolimus-eluting stents (EES) and drug-eluting balloons (DEB) in patients with bare-metal stent in-stent restenosis (ISR). The relative long-term clinical efficacy of current therapeutic modalities in patients with ISR remains unknown. The 3-year clinical follow-up (pre-specified endpoint) of patients included in the RIBS V (Restenosis Intra-Stent of Bare-Metal Stents: Drug-Eluting Balloon vs Everolimus-Eluting Stent Implantation) randomized clinical trial was analyzed. All patients were followed yearly using a pre-defined structured questionnaire. A total of 189 patients with bare-metal stent ISR were allocated to either EES (n = 94) or DEB (n = 95). Clinical follow-up at 1, 2, and 3 years was obtained in all patients (100%). Compared with patients treated with DEB, those treated with EES obtained better angiographic results, including larger minimal luminal diameter at follow-up (primary study endpoint; 2.36 ± 0.6 mm vs. 2.01 ± 0.6 mm; p < 0.001). At 3 years, the rates of cardiac death (2% vs. 1%), myocardial infarction (4% vs. 5%) and target vessel revascularization (9% vs. 5%) were similar in the DEB and EES arms. Importantly, however, at 3 years, the rate of target lesion revascularization was significantly lower in the EES arm (2% vs. 8%; p = 0.04; hazard ratio: 0.23; 95% confidence interval: 0.06 to 0.93). The need for "late" (>1 year) target vessel (3 [3.2%] vs. 3 [3.2%]; p = 0.95) and target lesion (1 [1%] vs. 2 [2.1%]; p = 0.54) revascularization was low and similar in the 2 arms. Rates of definite or probable stent thrombosis (1% vs. 0%) were also similar in the 2 arms. The 3-year clinical follow-up of the RIBS V clinical trial confirms the sustained safety and efficacy of EES and DEB in patients treated for bare-metal stent ISR. In this setting, EES reduce the need for target lesion revascularization at very long-term follow-up. (RIBS V [Restenosis Intra-Stent of Bare Metal Stents

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

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lee, S; Li, Z; Jalaj, S

2014-06-01

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, Evolutionmore » 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 perturbations (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

Systematic review and meta-analysis of metal versus plastic stents for preoperative biliary drainage in resectable periampullary or pancreatic head tumors.

PubMed

Crippa, S; Cirocchi, R; Partelli, S; Petrone, M C; Muffatti, F; Renzi, C; Falconi, M; Arcidiacono, P G

2016-09-01

Preoperative biliary drainage (PBD) with stenting increases complications compared with surgery without PBD. Metallic stents are considered superior to plastic stents when considering stent-related complications. Aim of the present systematic review and meta-analysis is to compare the rate of endoscopic re-intervention before surgery and postoperative outcomes of metal versus plastic stents in patients with resectable periampullary or pancreatic head neoplasms. We conducted a bibliographic research using the National Library of Medicine's PubMed database, including both randomized controlled trials (RCTs) and non-RCTs. Quantitative synthesis was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. Statistical heterogeneity was assessed using the I(2) tests. One RCT and four non-RCTs were selected, including 704 patients. Of these, 202 patients (29.5%) were treated with metal stents and 502 (70.5%) with plastic stents. The majority of patients (86.4%) had pancreatic cancer. The rate of endoscopic re-intervention after preoperative biliary drainage was significantly lower in the metal stent (3.4%) than in the plastic stent (14.8%) group (p < 0.0001). The rate of postoperative pancreatic fistula was significantly lower in the meta stent group as well (5.1% versus 11.8%, p = 0.04). The rate of post-operative surgical complications and of - post-operative mortality did not differ between the two groups. Although the present systematic review and meta-analysis demonstrates that metal stent are more effective than plastic stents for PBD in patients with resectable periampullary tumors, randomized controlled trials are needed in order to confirm these data with a higher level of evidence. Copyright © 2016 Elsevier Ltd. All rights reserved.

Mechanical properties of different airway stents.

PubMed

Ratnovsky, Anat; Regev, Noa; Wald, Shaily; Kramer, Mordechai; Naftali, Sara

2015-04-01

Airway stents improve pulmonary function and quality of life in patients suffering from airway obstruction. The aim of this study was to compare main types of stents (silicone, balloon-dilated metal, self-expanding metal, and covered self-expanding metal) in terms of their mechanical properties and the radial forces they exert on the trachea. Mechanical measurements were carried out using a force gauge and specially designed adaptors fabricated in our lab. Numerical simulations were performed for eight different stent geometries, inserted into trachea models. The results show a clear correlation between stent diameter (oversizing) and the levels of stress it exerts on the trachea. Compared with uncovered metal stents, metal stents that are covered with less stiff material exert significantly less stress on the trachea while still maintaining strong contact with it. The use of such stents may reduce formation of mucosa necrosis and fistulas while still preventing stent migration. Silicone stents produce the lowest levels of stress, which may be due to weak contact between the stent and the trachea and can explain their propensity for migration. Unexpectedly, stents made of the same materials exerted different stresses due to differences in their structure. Stenosis significantly increases stress levels in all stents. Copyright © 2015 IPEM. Published by Elsevier Ltd. All rights reserved.

Self-Expanding Metal Stents Improve Swallowing and Maintain Nutrition During Neoadjuvant Therapy for Esophageal Cancer.

PubMed

Smith, Zachary L; Gonzaga, Jason E; Haasler, George B; Gore, Elizabeth M; Dua, Kulwinder S

2017-06-01

Patients with locally advanced esophageal cancer can have significant dysphagia. Nutritional support during neoadjuvant therapy is often delivered via nasoenteric or percutaneous feeding tubes. These approaches do not allow for per-oral feeding. Evaluate the safety and efficacy of fully covered self-expanding metal esophageal stents for nutritional support during neoadjuvant therapy. This was a pilot, prospective study at a single tertiary center. From March 2012 to May 2013, consecutive patients with esophageal cancer eligible for neoadjuvant therapy were enrolled. Metal stents were placed prior to starting neoadjuvant therapy. Data were collected at baseline and predetermined intervals until an endpoint (surgery or disease progression). Outcomes included dysphagia grade, satisfaction of swallowing score, nutritional status (weight, serum albumin), impact on surgery, and adverse events. Fourteen stents were placed in 12 patients (59.1 ± 9.5 years, 11 men, 1 woman). Dysphagia grade (pre 3.4 ± 0.5 vs post 0.2 ± 0.4, p < 0.0001) and swallowing scores (20.2 ± 5.9 vs 6.3 ± 4.7, p < 0.0001) significantly improved after stent placement. Improvements were sustained throughout neoadjuvant therapy. Body weight and serum albumin levels remained stable. Adverse events included severe chest pain (2), food impaction (1), and delayed stent migration (2). Five patients underwent surgical resection. No significant chemoradiation or operative adverse events occurred due to the presence of a stent. During neoadjuvant therapy for esophageal cancer, self-expanding metal stents are safe and effective in relieving dysphagia and maintaining nutrition. They allow patients to eat orally, thereby improving patient satisfaction. The presence of an in situ stent did not interfere with surgery.

Tracheal Self-Expandable Metallic Stents: A Comparative Study of Three Different Stents in a Rabbit Model.

PubMed

Serrano, Carolina; Lostalé, Fernando; Rodríguez-Panadero, Francisco; Blas, Ignacio de; Laborda, Alicia; de Gregorio, Miguel Angel

2016-03-01

The objective of this study was to assess tracheal reactivity after the deployment of different self-expandable metal stents (SEMS). Forty female New Zealand rabbits were divided into four groups. Three groups received three different SEMS: steel (ST), nitinol (NiTi), or nitinol drug-eluting stent (DES); the fourth group was the control group (no stent). Stents were deployed percutaneously under fluoroscopic guidance. Animals were assessed by multi-slice, computed tomography (CT) scans, and tracheas were collected for anatomical pathology (AP) study. Data from CT and AP were statistically analyzed and correlated. The DES group had the longest stenosis (20.51±14.08mm vs. 5.84±12.43 and 6.57±6.54mm in NiTi and ST, respectively, day 30; P<.05), and higher granuloma formation on CT (50% of cases). The NiTi group showed the lowest grade of stenosis (2.86±6.91% vs. 11.28±13.98 and 15.54±25.95% in DES and ST, respectively; P<.05). The AP study revealed that the ST group developed intense proliferative reactivity compared to the other groups. In the DES group, a destructive response was observed in 70% of the animals, while the NiTi was the least reactive stent. CT was more effective in detecting wall thickening (positive correlation of 68.9%; P<.001) than granuloma (not significant). The ST group developed granulomas and significant stenosis. NiTi was the least reactive stent, while DES caused significant lesions that may be related to drug dosage. This type of DES stent is therefore not recommended for the treatment of tracheobronchial stenosis. Copyright © 2015 SEPAR. Published by Elsevier Espana. All rights reserved.

Palliation of Malignant Biliary and Duodenal Obstruction with Combined Metallic Stenting

DOE Office of Scientific and Technical Information (OSTI.GOV)

Akinci, Devrim, E-mail: akincid@hotmail.com; Akhan, Okan; Ozkan, Fuat

2007-11-15

Purpose. The purpose of this study is to evaluate the efficacy of palliation of malignant biliary and duodenal obstruction with combined metallic stenting under fluoroscopy guidance. Materials and Methods. A retrospective analysis of 9 patients (6 men and 3 women) who underwent biliary and duodenal stenting was performed. The mean age of patients was 61 years (range: 42-80 years). The causes of obstruction were pancreatic carcinoma in 7 patients, cholangiocellular carcinoma in one, and duodenal carcinoma in the other. Biliary and duodenal stents were placed simultaneously in 4 patients. In other 5 patients dudodenal stents were placed after biliary stentingmore » when the duodenal obstruction symptoms have developed. In two patients duodenal stents were advanced via transgastric approach. Results. Technical success rate was 100 %. After percutaneous biliary drainage and stenting bilirubin levels decreased to normal levels in 6 patients and in remaining 3 patients mean reduction of 71% in bilirubin levels was achieved. Tumoral ingrowth occurred in one patient and percutaneous biliary restenting was performed 90 days after the initial procedure. Of the 9 patients, 6 patients were able to tolerate solid diet, whereas 2 patients could tolerate liquid diet and one patient did not show any improvement. Mean survival periods were 111 and 73 days after biliary and duodenal stenting, respectively. Conclusion. Combined biliary and duodenal stent placement which can be performed under fluoroscopic guidance without assistance of endoscopy is feasible and an effective method of palliation of malignant biliary and duodenal obstructions. If transoral and endoscopic approaches fail, percutaneous gastrostomy route allows duodenal stenting.« less

Preoperative biliary decompression preceding pancreaticoduodenectomy with plastic or self-expandable metallic stent.

PubMed

Haapamäki, C; Seppänen, H; Udd, M; Juuti, A; Halttunen, J; Kiviluoto, T; Sirén, J; Mustonen, H; Kylänpää, L

2015-06-01

The rainage (PBD) prior to pancreaticoduodenectomy (PD) is controversial. If PBD is required, large bore self-expandable metallic stents (SEMS) are thought to maintain better drainage and have fewer postoperative complications than plastic stents. The confirming evidence is scarce. The aim of the study was to compare outcomes of surgery in patients who underwent PBD with SEMS or plastic stents deployed at endoscopic retrograde cholangiopancreatography (ERCP). This is a retrospective study of 366 patients having had PD during 2000-2009. Preceding endoscopic PBD was performed in 191 patients and nine had had percutaneous transhepatic drainage (PTD). At the time of operation, 163 patients had a plastic stent and 28 had SEMS. Due to stent exchanges, 176 plastic stents and 29 SEMS were placed in all. The stent failure rate was 7.4% for plastic stents and 3.4% for SEMS (p = 0.697). A bilirubin level under 50 µmol/L was reached by 80% of the patients with plastic stents and by 61% of the patients with SEMS (p = 0.058). A postoperative infection complication and/or a pancreatic fistula was found in 26% while using plastic stents and in 25% using SEMS (p = 1.000). In unstented patients with biliary obstruction, the bile juice was sterile significantly more often than in endoscopically stented patients (100% vs 1%, p < 0.001). When the stented and unstented patients were compared regarding postoperative infection complications, there was no significant difference between the groups (p = 0.365). Plastic stents did not differ from SEMS regarding the stent failure rate, bilirubin level decrease, amount of bacteria in the bile juice, or postoperative complications when used for PBD. The significantly higher price of SEMS suggests their use in selected cases only. © The Finnish Surgical Society 2014.

Fiber laser micromachining of thin NiTi tubes for shape memory vascular stents

NASA Astrophysics Data System (ADS)

Liu, Lei; Li, Dong Bo; Tong, Yi Fei; Zhu, Yu Fu

2016-07-01

Nickel titanium (NiTi) alloy has widely been used in the vascular stent manufacturing due to its excellent properties. Neodymium-doped yttrium aluminum garnet (Nd:YAG) laser is commonly used for the preparation of metal vascular stents. Recently, fiber lasers have been used for stent profiling for better cutting quality. To investigate the cutting-kerf characters of NiTi vascular stents fabricated by fiber laser cutting, laser cutting experiments with thin NiTi tubes were conducted in this study, while NiTi sheets were used in other fiber laser cutting studies. Different with striation topography, new topographies such as layer topography and topography mixed with layers and striations were observed, and the underlying reason for new topographies was also discussed. Comparative research on different topographies was conducted through analyzing the surface roughness, kerf width, heat-affected zone (HAZ) and dross formation. Laser cutting process parameters have a comprehensive influence on the cutting quality; in this study, the process parameters' influences on the cutting quality were studied from the view of power density along the cutting direction. The present research provides a guideline for improving the cutting quality of NiTi vascular stents.

Stent Thrombosis in Drug-Eluting or Bare-Metal Stents in Patients Receiving Dual Antiplatelet Therapy.

PubMed

Kereiakes, Dean J; Yeh, Robert W; Massaro, Joseph M; Driscoll-Shempp, Priscilla; Cutlip, Donald E; Steg, P Gabriel; Gershlick, Anthony H; Darius, Harald; Meredith, Ian T; Ormiston, John; Tanguay, Jean-François; Windecker, Stephan; Garratt, Kirk N; Kandzari, David E; Lee, David P; Simon, Daniel I; Iancu, Adrian Corneliu; Trebacz, Jaroslaw; Mauri, Laura

2015-10-01

This study sought to compare rates of stent thrombosis and major adverse cardiac and cerebrovascular events (MACCE) (composite of death, myocardial infarction, or stroke) after coronary stenting with drug-eluting stents (DES) versus bare-metal stents (BMS) in patients who participated in the DAPT (Dual Antiplatelet Therapy) study, an international multicenter randomized trial comparing 30 versus 12 months of dual antiplatelet therapy in subjects undergoing coronary stenting with either DES or BMS. Despite antirestenotic efficacy of coronary DES compared with BMS, the relative risk of stent thrombosis and adverse cardiovascular events is unclear. Many clinicians perceive BMS to be associated with fewer adverse ischemic events and to require shorter-duration dual antiplatelet therapy than DES. Prospective propensity-matched analysis of subjects enrolled into a randomized trial of dual antiplatelet therapy duration was performed. DES- and BMS-treated subjects were propensity-score matched in a many-to-one fashion. The study design was observational for all subjects 0 to 12 months following stenting. A subset of eligible subjects without major ischemic or bleeding events were randomized at 12 months to continued thienopyridine versus placebo; all subjects were followed through 33 months. Among 10,026 propensity-matched subjects, DES-treated subjects (n = 8,308) had a lower rate of stent thrombosis through 33 months compared with BMS-treated subjects (n = 1,718, 1.7% vs. 2.6%; weighted risk difference -1.1%, p = 0.01) and a noninferior rate of MACCE (11.4% vs. 13.2%, respectively, weighted risk difference -1.8%, p = 0.053, noninferiority p < 0.001). DES-treated subjects have long-term rates of stent thrombosis that are lower than BMS-treated subjects. (The Dual Antiplatelet Therapy Study [DAPT study]; NCT00977938). Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

'Stent in a stent'--an alternative technique for removing partially covered stents following sleeve gastrectomy complications.

PubMed

Vasilikostas, Georgios; Sanmugalingam, Nimalan; Khan, Omar; Reddy, Marcus; Groves, Chris; Wan, Andrew

2014-03-01

Endoscopic stenting is a relatively new technique for the treatment of post sleeve gastrectomy complications. Partially covered stents are used in this method to minimise the risk of migration but they are associated with difficulties with removal. Patients requiring emergency stenting following sleeve gastrectomy underwent insertion of a partially covered metallic stent. One month later, if the stent was not easily removable, a fully covered overlapping stent was inserted and the patient was readmitted 2 weeks later for removal of both stents. Four patients required stenting following sleeve gastrectomy leaks, and one patient required stenting for a stricture. In these cases, a 'stent in a stent' technique was used for removal. This technique allows the safe removal of partially covered stents inserted following sleeve gastrectomy complications.

Fully Covered Metallic Stents for the Treatment of Benign Airway Stenosis

PubMed Central

Ocak, Sebahat; Gourdin, Maximilien; d'Odémont, Jean-Paul

2016-01-01

Introduction. We herein report our experience with new fully covered self-expanding metallic stents in the setting of inoperable recurrent benign tracheobronchial stenosis. Methods. Between May 2010 and July 2014, 21 Micro-Tech® FC-SEMS (Nanjing Co., Republic of Korea) were placed in our hospital in 16 patients for inoperable, recurrent (after dilatation), and symptomatic benign airway stenosis. Their medical files were retrospectively reviewed in December 2014, with focus on stent's tolerance and durability data. Results. Twenty-one stents were inserted: 13 for posttransplant left main bronchus anastomotic stricture, seven for postintubation tracheal stenosis, and one for postlobectomy anastomotic stricture. Positioning was easy for all of them. Stents were in place for a mean duration of 282 days. The most common complications were granulation tissue development (35%), migration (30%), and sputum retention (15%). Fifty-five % of the stents (11/20) had to be removed because of various complications, without difficulty for all of them. None of the patients had life-threatening complications. Conclusion. Micro-Tech FC-SEMS were easy to position and to remove. While the rate of complications requiring stent removal was significant, no life-threatening complication occurred. Further studies are needed to better define their efficacy and safety in the treatment of benign airway disease. PMID:27777507

Fully Covered Metallic Stents for the Treatment of Benign Airway Stenosis.

PubMed

Dahlqvist, Caroline; Ocak, Sebahat; Gourdin, Maximilien; Dincq, Anne Sophie; Putz, Laurie; d'Odémont, Jean-Paul

2016-01-01

Introduction. We herein report our experience with new fully covered self-expanding metallic stents in the setting of inoperable recurrent benign tracheobronchial stenosis. Methods. Between May 2010 and July 2014, 21 Micro-Tech® FC-SEMS (Nanjing Co., Republic of Korea) were placed in our hospital in 16 patients for inoperable, recurrent (after dilatation), and symptomatic benign airway stenosis. Their medical files were retrospectively reviewed in December 2014, with focus on stent's tolerance and durability data. Results. Twenty-one stents were inserted: 13 for posttransplant left main bronchus anastomotic stricture, seven for postintubation tracheal stenosis, and one for postlobectomy anastomotic stricture. Positioning was easy for all of them. Stents were in place for a mean duration of 282 days. The most common complications were granulation tissue development (35%), migration (30%), and sputum retention (15%). Fifty-five % of the stents (11/20) had to be removed because of various complications, without difficulty for all of them. None of the patients had life-threatening complications. Conclusion. Micro-Tech FC-SEMS were easy to position and to remove. While the rate of complications requiring stent removal was significant, no life-threatening complication occurred. Further studies are needed to better define their efficacy and safety in the treatment of benign airway disease.

Hemodynamics of 8 different configurations of stenting for bifurcation aneurysms.

PubMed

Kono, K; Terada, T

2013-10-01

SACE is performed for complex aneurysms. There are several configurations of stent placement for bifurcation aneurysms. We investigated hemodynamics among 8 different configurations of stent placement, which may relate to the recanalization rate. We created a silicone block model of a patient-specific asymmetric bifurcation aneurysm. Enterprise closed-cell stents were deployed in the model as various configurations. 3D images of these stents were obtained by micro-CT. We performed CFD simulations for a no-stent model and 8 stent models: a single stent from a proximal vessel to a right or left distal vessel, a horizontal stent, a kissing-Y stent with a uniformly narrowed structure, a nonoverlapping-Y stent, a virtual-Y stent with no narrowed structure (fusion of 2 single stents), and 2 different crossing-Y stents with a focally narrowed structure. Hemodynamic parameters were evaluated. Cycle-averaged velocity and WSS in the aneurysm were reduced because of stent placement in the following order: single stent (19% reduction in cycle-averaged velocity) < nonoverlapping-Y stent (29%) < virtual-Y stent (32%) < horizontal stent (39%) < kissing-Y stent (48%) < crossing-Y stent (54%). Kissing- and crossing-Y stents redirected impingement flow into the distal vessels because of lowered porosity of stents due to narrowed structures. Among 8 different configurations of stent placement, kissing- and crossing-Y stents showed the strongest reduction in flow velocity in the aneurysm because of lowered porosity of stents and redirection of impingement flow. This may be a desirable reconstruction of flow hemodynamics and may decrease recanalization rates in SACE.

[How to prevent tissue overgrowth and incrustation of metal stents in the urinary tract in patients with pelvic malignancy] b ].

PubMed

Marković, Z; Masulović, D; Markovic, B; Anojcić, P; Mladenović, A

2009-01-01

At the current level of stent application in urology each irreversible urostasis contraindicated for surgical therapy implies consideration of indications for metal stent insertion. Stent incrustation which leads directly into a new uroobstruction is a characteristic complication of this method. Available experience in different uroobstructive conditions has shown that very different clinical aspects of stent usage may directly determine the possibility of their incrustation. Stent incrustation may occur in the early postprocedural course or several months later. After that, prevention of stent incrustation starts with postprocedural evaluation, selection of the stent type, and it is subsequently continued by insertion technique and lasts practically permanently after the insertion (infection control, promotion of diuresis and maintenance of normal urodynamics). Authors present own experianse in clinical aplication of metal stents in uroradiology strictures for period of last 15 years.

Do expandable metallic airway stents have a role in the management of patients with benign tracheobronchial disease?

PubMed

Madden, Brendan P; Loke, Tuck-Kay; Sheth, Abhijat C

2006-07-01

With increasing availability many centers are deploying expandable metallic stents to manage patients with diverse endobronchial disorders. Although these devices have an important role in malignant disease their usefulness in benign large airway disorders is less defined. Between 1997 and 2005, 31 patients aged 34 to 83 years with benign large airway compromise secondary to tracheomalacia (n = 7), posttracheostomy stricture (n = 8), posttracheostomy rupture (n = 2), postpneumonectomy bronchopleural fistula (n = 2), stricture after lung transplantation (n = 3), lobectomy, tuberculosis, traumatic injury to right main bronchus (n = 1 patient each), and external compression of the airway secondary to achalasia, multinodular goiter, aortic aneurysm, right brachiocephalic artery aneurysm, right interrupted aortic arch, and dissecting aneurysm (n = 1 patient each) who were medically unfit for formal surgical intervention were treated by Ultraflex stent deployment. The range of follow-up was 1 week to 96 months. Stents were deployed under anesthesia using rigid bronchoscopy. Complications included granulation tissue formation (n = 11) treated with Nd: YAG laser ablation, stent migration (n = 1; stent removed, another deployed), metal fatigue (n = 1), stent removal (n = 1), mucus plugging (n = 2), and halitosis (n = 6) difficult to treat despite antibiotics. Thirteen patients died of unrelated causes between 1 week and 15 months after stent deployment. Endobronchial metallic stents should be considered only for selected patients with large airway compromise secondary to benign airway diseases for whom other medical comorbidities contraindicate formal airway surgery. Once deployed, they are difficult to remove, are associated with significant complications, and require prospective bronchoscopic surveillance and often further therapeutic intervention.

Partially covered metal stents have longer patency than uncovered and fully covered metal stents in the management of distal malignant biliary obstruction: a retrospective study.

PubMed

Yokota, Yudai; Fukasawa, Mitsuharu; Takano, Shinichi; Kadokura, Makoto; Shindo, Hiroko; Takahashi, Ei; Hirose, Sumio; Kawakami, Satoshi; Fukasawa, Yoshimitsu; Sato, Tadashi; Enomoto, Nobuyuki

2017-10-11

Self-expandable metal stents (SEMSs) are widely used for malignant biliary obstructions. Nitinol-covered SEMSs have been developed to improve stent patency. Currently, SEMSs may be uncovered, partially covered, or fully covered; however, there is no consensus on the best stent type for the management of malignant distal biliary obstruction (MDBO). Patients with unresectable MDBO receiving SEMS (Wallflex™) were retrospectively analyzed. Time to recurrent biliary obstruction (TRBO) and survival time were compared among the three types of SEMSs. Univariate and multivariate analyses were performed to identify risk factors for stent dysfunction. In total, 101 patients received SEMSs for unresectable MDBO (44 uncovered, 28 partially covered, and 29 fully covered SEMSs). Median survival time was 200, 168, and 276 days in the uncovered, partially covered, and fully covered SEMSs groups, respectively. There were no differences in survival among the three groups. Median TRBO was 199, 444, and 194 days in the uncovered, partially covered, and fully covered SEMSs groups, respectively. Partially covered SEMSs had longer TRBO than uncovered (p = 0.013) and fully covered (p = 0.010) SEMSs. Tumor ingrowth occurred only with uncovered SEMSs and stent migration occurred only with fully covered SEMSs. Multivariate analyses confirmed that partially covered SEMSs have lower risk of dysfunction. Partially covered SEMSs with a proximal uncovered flared end have longer patency than uncovered and fully covered SEMSs by preventing tumor ingrowth and stent migration.

Stent fabric fatigue of grafts supported by Z-stents versus ringed stents: an in vitro buckling test.

PubMed

Lin, Jing; Wang, Lu; Guidoin, Robert; Nutley, Mark; Song, Ge; Zhang, Ze; Du, Jia; Douville, Yvan

2014-03-01

Stent-grafts externally fitted with a Z-shaped stents were compared to devices fitted with ringed stents in an in vitro oscillating fatigue machine at 200 cycles per minute and a pressure of 360 mmHg for scheduled durations of up to 1 week. The devices fitted with Z-stents showed a considerably lower endurance limit to buckling compared to the controls. The contact between the apexes of adjacent Z-stents resulted in significant damage to the textile scaffolds and polyester fibers due to the sharp angle of the Z-stents. The ringed stents did not cause any fraying in the textile scaffolds.

Treatment of benign and malignant tracheobronchial obstruction with metal wire stents: experience with a balloon-expandable and a self-expandable stent type.

PubMed

Rieger, Johannes; Hautmann, Hubert; Linsenmaier, Ulrich; Weber, Cristoph; Treitl, Markus; Huber, Rudolf Maria; Pfeifer, Klaus-Jürgen

2004-01-01

Over the last few years various types of metal wire stents have been increasingly employed in the treatment of both malignant and benign tracheobronchial obstruction. To date, however, few studies have investigated the in vivo properties of different stent types. We implanted 26 balloon-expandable tantalum Strecker stents (18 patients) and 18 self-expandable Wallstents (16 patients) into the tracheobronchial system of 30 patients with combined stenting in 4 patients. Mean age was 51 years (range: 0.5-79 years). Malignant disease was present in 23 patients, benign disease in seven patients. Both patients and individual stents were monitored clinically and radiographically. The probability of stents remaining within the tracheobronchial system, and of their remaining undislocated and uncompressed was calculated using Kaplan-Meier analysis for both stent types. Average stent follow-up time was 112 days until explantation and 115 days until patients' death or discharge. Kaplan-Meier analysis revealed a higher probability for the Wallstent to remain within the tracheobronchial system. Dislocation and compression occurred more rarely. Explantation, however, if desired, was more difficult compared to the Strecker stent. The Wallstent also led to the formation of granulation tissue, especially at the proximal stent end, frequently requiring reintervention. Both stent types proved to be effective therapeutic options in the management of obstructive tracheobronchial disease. The mechanical properties of the Strecker stent seem to be less favorable compared to the Wallstent but removal is easy. For benign disease, however, the Wallstent reveals limitations due to significant side effects.

Local Delivery of Gene Vectors From Bare-Metal Stents by Use of a Biodegradable Synthetic Complex Inhibits In-Stent Restenosis in Rat Carotid Arteries

PubMed Central

Fishbein, Ilia; Alferiev, Ivan; Bakay, Marina; Stachelek, Stanley J.; Sobolewski, Peter; Lai, Meizan; Choi, Hoon; Chen, I.-W.; Levy, Robert J.

2012-01-01

Background Local drug delivery from polymer-coated stents has demonstrated efficacy for preventing in-stent restenosis; however, both the inflammatory effects of polymer coatings and concerns about late outcomes of drug-eluting stent use indicate the need to investigate innovative approaches, such as combining localized gene therapy with stent angioplasty. Thus, we investigated the hypothesis that adenoviral vectors (Ad) could be delivered from the bare-metal surfaces of stents with a synthetic complex for reversible vector binding. Methods and Results We synthesized the 3 components of a gene vector binding complex: (1) A polyallylamine bisphosphonate with latent thiol groups (PABT), (2) a polyethyleneimine (PEI) with pyridyldithio groups for amplification of attachment sites [PEI(PDT)], and (3) a bifunctional (amine- and thiol-reactive) cross-linker with a labile ester bond (HL). HL-modified Ad attached to PABT/PEI(PDT)-treated steel surfaces demonstrated both sustained release in vitro over 30 days and localized green fluorescent protein expression in rat arterial smooth muscle cell cultures, which were not sensitive to either inhibition by neutralizing anti-Ad antibodies or inactivation after storage at 37°C. In rat carotid studies, deployment of steel stents configured with PABT/PEI(PDT)/HL-tethered adenoviral vectors demonstrated both site-specific arterial AdGFP expression and adenovirus-luciferase transgene activity per optical imaging. Rat carotid stent delivery of adenovirus encoding inducible nitric oxide synthase resulted in significant inhibition of restenosis. Conclusions Reversible immobilization of adenovirus vectors on the bare-metal surfaces of endovascular stents via a synthetic complex represents an efficient, tunable method for sustained release of gene vectors to the vasculature. PMID:18413497

Randomized multicenter study of multiple plastic stents vs. covered self-expandable metallic stent in the treatment of biliary stricture in chronic pancreatitis.

PubMed

Haapamäki, Carola; Kylänpää, Leena; Udd, Marianne; Lindström, Outi; Grönroos, Juha; Saarela, Arto; Mustonen, Harri; Halttunen, Jorma

2015-07-01

The use of covered self-expandable metallic stents (cSEMS) in benign biliary indications is evolving. The aim of the study was to assess the safety and feasibility of cSEMS compared with multiple plastic stents in the treatment of benign biliary stricture (BBS) caused by chronic pancreatitis. This was a prospective, multicenter, randomized study of 60 patients with BBS caused by chronic pancreatitis. All patients received an initial plastic stent before randomization. At randomization, the stent was replaced either with a single cSEMS or three plastic stents. After 3 months, the position of the cSEMS was checked or another three plastic stents were added. At 6 months after randomization, all stents were removed. Clinical follow-up including abdominal ultrasound and laboratory tests were performed at 6 months and 2 years after stent removal. Two patients dropped out of the cSEMS group before stent removal. In April 2014, the median follow-up was 40 months (range 1 - 66 months). The 2-year, stricture-free success rate was 90 % (95 % confidence interval [CI] 72 % - 97 %) in the plastic stent group and 92 % (95 %CI 70 % - 98 %) in the cSEMS group (P = 0.405). There was one late recurrence in the plastic stent group 50 months after stent removal. Stent migration occurred three times (10 %) in the plastic stent group and twice in the cSEMS group (7 %; P = 1.000). A 6-month treatment with either six 10-Fr plastic stents or with one 10-mm cSEMS produced good long-term relief of biliary stricture caused by chronic pancreatitis.Study registered at ClinicalTrials.gov (NCT01085747). © Georg Thieme Verlag KG Stuttgart · New York.

Efficacy of a Multiplex Paclitaxel Emission Stent Using a Pluronic® Mixture Membrane versus a Covered Metal Stent in Malignant Biliary Obstruction: A Prospective Randomized Comparative Study.

PubMed

Jang, Sung Ill; Lee, Se Joon; Jeong, Seok; Lee, Don Haeng; Kim, Myung-Hwan; Yoon, Hong Jin; Lee, Dong Ki

2017-07-15

A drug-eluting stent for unresectable malignant biliary obstruction was developed to increase stent patency by preventing tumor ingrowth. The safety and efficacy of a new generation of metallic stents covered with a paclitaxel-incorporated membrane using a Pluronic ® mixture (MSCPM-II) were compared prospectively with those of covered metal stents (CMSs) in patients with malignant biliary obstructions. This study was initially designed as a prospective randomized trial but was closed early because of a high incidence of early occlusion. Therefore, the data were analyzed using the intent-to-treat method. A total of 72 patients with unresectable distal malignant biliary obstructions were prospectively enrolled. The two groups did not differ significantly in basic characteristics and mean follow-up period (MSCPM-II 194 days vs CMS 277 days, p=0.063). Stent occlusion occurred in 14 patients (35%) who received MSCPM-II and in seven patients (21.9%) who received CMSs. Stent patency and survival time did not significantly differ between the two groups (p=0.355 and p=0.570). The complications were mild and resolved by conservative management in both groups. There were no significant differences in stent patency or patient survival in MSCPM-II and CMS patients with malignant biliary obstructions.

Use of Self-Expanding Metallic Ureteral Stents in the Secondary Treatment of Ureteral Stenosis Following Kidney Transplantation.

PubMed

Xu, Guibin; Li, Xun; He, Yongzhong; Zhao, Haibo; Yang, Weiqing; Xie, Qingling

2015-10-01

To evaluate the safety and efficacy of self-expanding metal stents in the treatment of ureteral stenosis following kidney transplantation. Seven patients who developed benign stenosis after kidney transplantation were treated by a self-expanding metallic stent implantation from June 2007 to March 2014. All patients had undergone at least one open surgical procedure and one endourologic procedure for treatment of the stenosis. The extent of stenosis varied from 1.2 to 3.7 cm. Ultrasonography, urography, diuretic renography, and urine culture were performed every 3 months after stent insertion. Ureteroscopic examination was performed when needed. Stent placement was technically effective in all cases. The mean operative time was 37 minutes (range, 26-59 minutes). Lower urinary-tract symptoms and the ipsilateral flank pain were common early-stage complications and were greatly relieved after an average of 3 months. The mean follow-up duration was 38 months (range, 13-86 months), and no stent migration or fragmentation was observed. Urothelial hyperplasia occurred in only one patient and was effectively managed with a Double-J stent. Five patients had normal stable renal function; the remaining two had impaired renal function, including one patient with a preoperative renal failure who required dialysis at the end of the follow-up period (36 months). As an alternative to open surgery, implantation of a self-expanding metal stent is a safe and effective treatment for ureteral stenosis in patients who have undergone kidney transplantation.

Biliary intraductal metastasis from advanced gastric cancer: radiologic and histologic characteristics, and clinical outcomes of percutaneous metallic stent placement.

PubMed

Lee, JooYeon; Gwon, Dong Il; Ko, Gi-Young; Kim, Jong Woo; Sung, Kyu-Bo

2016-06-01

To investigate the radiologic and histological characteristics of biliary intraductal metastasis of advanced gastric cancer and the clinical outcomes of percutaneous, metallic stent placement. We retrospectively assessed 24 patients with obstructive jaundice related to biliary intraductal metastasis of gastric cancers who underwent PTBD and subsequent metallic stent placement between 2003 and 2012. Intraductal metastases appeared as uniform, concentric, linear (n = 17) or band-like (n = 7), enhanced wall thickening on CT, and 20 patients (83.3 %) had cystic ductal lesions. On pathology specimens, malignant cells scattered in the submucosal layer caused a desmoplastic reaction. The technical and clinical success rate of stent placement was achieved in all 24 patients. The median survival time was 203 days. Stent occlusion was observed in four patients with 49-278 days following stent placement. The median stent patency time was 156 days. The radiologic and histological characteristics of biliary intraductal metastasis of advanced gastric cancer consist of uniform, linear or band-like, enhanced biliary wall thickening and malignant cells scattered in the submucosal layer, together with the desmoplastic reaction without any disruption of the epithelial layer. Uncovered metallic stent placement was also a safe and effective method of palliative treatment in these patients. • The CT findings of intraductal metastasis were linear/band-like, enhanced biliary wall thickening. • The histological finding was malignant cells scattered in the submucosal layer. • It showed a desmoplastic reaction without any disruption of the epithelial layer. • Uncovered metallic stent placement was a safe and effective palliative treatment.

Conformable covered versus uncovered self-expandable metallic stents for palliation of malignant gastroduodenal obstruction: a randomized prospective study.

PubMed

Lim, Sun Gyo; Kim, Jin Hong; Lee, Kee Myung; Shin, Sung Jae; Kim, Chan Gyoo; Kim, Kyung Ho; Kim, Ho Gak; Yang, Chang Heon

2014-07-01

A conformable self-expandable metallic stent was developed to overcome the limitation of previous self-expandable metallic stents. The aim of this study was to evaluate outcomes after placement of conformable covered and uncovered self-expandable metallic stents for palliation of malignant gastroduodenal obstruction. A single-blind, randomized, parallel-group, prospective study were conducted in 4 medical centres between March 2009 and July 2012. 134 patients with unresectable malignant gastroduodenal obstruction were assigned to a covered double-layered (n=66) or uncovered unfixed-cell braided (n=68) stent placement group. Primary analysis was performed to compare re-intervention rates between two groups. 120 patients were analysed (59 in the covered group and 61 in the uncovered group). Overall rates of re-intervention were not significantly different between the two groups: 13/59 (22.0%) in the covered group vs. 13/61 (21.3%) in the uncovered group, p=0.999. Stent migration was more frequent in the covered group than in the uncovered group (p=0.003). The tumour ingrowth rate was higher in the uncovered group than in the covered group (p=0.016). The rates of re-intervention did not significantly differ between the two stents. Conformable covered double-layered and uncovered unfixed-cell braided stents were associated with different patterns of stent malfunction. Copyright © 2014 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

Endoscopic treatment of benign biliary strictures using covered self-expandable metal stents (CSEMS).

PubMed

Irani, Shayan; Baron, Todd H; Akbar, Ali; Lin, Otto S; Gluck, Michael; Gan, Ian; Ross, Andrew S; Petersen, Bret T; Topazian, Mark; Kozarek, Richard A

2014-01-01

Traditional endoscopic management of benign biliary strictures (BBS) consists of placement of one or more plastic stents. Emerging data support the use of covered self-expandable metal stents (CSEMS). We sought to assess outcome of endoscopic temporary placement of CSEMS in patients with BBS. This was a retrospective study of CSEMS placement for BBS between May 2005 and July 2012 from two tertiary care centers. A total of 145 patients (81 males, median age 59 years) with BBS were identified; 73 of which were classified as extrinsic and were caused by chronic pancreatitis, and 70 were intrinsic. Main outcome measures were resolution of stricture and adverse events (AEs) due to self-expandable metal stents (SEMS)-related therapy. Fully covered and partially covered 8-10 mm diameter SEMS were placed and subsequently removed in 121/125 (97 %) attempts in BBS (failure to remove four partially covered stents). Stricture resolution occurred in 83/125 (66 %) patients after a median stent duration of 26 weeks (median follow-up 90 weeks). Resolution of extrinsic strictures was significantly lower compared to intrinsic strictures (31/65, 48 % vs. 52/60, 87 %, p = 0.004) despite longer median stent duration (30 vs. 20 weeks). Thirty-seven AEs occurred in 25 patients (17 %), with 12 developing multiple AEs including cholangitis (n = 17), pancreatitis (n = 5), proximal stent migration (n = 3), cholecystitis (n = 2), pain requiring SEMS removal and/or hospitalization (n = 3), inability to remove (n = 4), and new stricture formation (n = 3). Benign biliary strictures can be effectively treated with CSEMS. Successful resolution of biliary strictures due to extrinsic disease is seen significantly less often than those due to intrinsic disease. Removal is successful in all patients with fully covered SEMS.

Management of embedded metallic stents used in the treatment of grades III and IV subglottic, and upper tracheal stenosis in adults.

PubMed

Sendi, Khalil; Al-Khatib, Talal; Ahmed, Duha G; Tonkul, Al-Baraa

2014-11-01

The aim of this study was to evaluate the post-operative complications of using balloon-expandable metallic stents in treatment of benign, major subglottic and tracheal stenosis in adult patients whom conventional therapy has failed and to demonstrate how to deal with these complications in the long run. A retrospective review of five cases; adlut patiets with benign, major subglottic and upper tracheal stenosis whom were treated with balloon expandable metallic stents at King Abdulaziz University Hospital, in the years between 2008 and 2013. Granulation tissue formed in five of the four cases and restenosis occurred. Other complications encountered were stent infection and dislodgment. The complications were managed by removing the stents surgically via a laryngofissure incision and required the placement of a Montgomery T-tube. Managing the restenosis due to granulation tissue formation around the metallic stents is best achieved by removing the embedded metallic stents surgically via open technique and then by placement of a Montgomery T-tube as a bridging option to successful decannulation. Open surgical procedures remain the mainstay treatment for advanced airway stenosis.

Distribution of nickel after modified nitinol stent implantation in animals

NASA Astrophysics Data System (ADS)

Chepeleva, E.; Sergeevichev, D.; Lotkov, A.; Kashin, O.; Korobeynikov, A.; Kozyr, K.; Baystrukov, V.; Zubarev, D.; Kretov, E.; Pokushalov, E.

2017-09-01

Intravascular stenting of arteries in atherosclerotic lesions is one of the most frequently performed procedures in cardiovascular surgery today. Most stents are made of various stainless-steel alloys and other metals (such as nitinol). Nitinol is a biocompatible, superplastic and corrosion resistant material with an important feature of shape memory. However, the composition of this alloy includes nickel, which shows toxicity to the kidneys, liver, lungs, heart and other organs when it accumulates in the organism. In this research we investigated the nickel content in serum, urine and hair of the laboratory animals after implantation of nitinol stents treated with plasma ionic surface modification by silicon.

Internal stenting in malignant biliary obstruction.

PubMed

Cowling, M G; Adam, A N

2001-03-01

Internal stenting in inoperable malignant biliary obstruction plays an important role in patient management. Surgical bypass may still be undertaken where there is also duodenal obstruction, though the need for gastroenterostomy may be reduced with the increasing use of metallic stents for the relief of malignant gastric outlet obstruction. Stents may be placed endoscopically or percutaneously, though in most centers the endoscopic route is usually tried first, with the percutaneous route being reserved for endoscopic failures. Plastic and self-expanding metallic biliary stents are available, each with its own advantages and disadvantages. In general, longer periods of patency are observed with metallic stents, though they are more expensive. Plastic stents can be changed endoscopically relatively easily when they have blocked, and in practice it is common for plastic stents to be inserted via this route for initial biliary drainage. If there is prolonged survival thereafter, many workers insert a metallic stent in an attempt to reduce the number of interventions required. If the percutaneous route is being employed, the histologic diagnosis has been confirmed, and the malignancy is inoperable, our practice is to use a self-expanding metallic stent, as the delivery system is relatively small and subsequent occlusion less likely.

Fully covered self-expanding metal stents for refractory anastomotic colorectal strictures.

PubMed

Caruso, Angelo; Conigliaro, Rita; Manta, Raffaele; Manno, Mauro; Bertani, Helga; Barbera, Carmelo; Mirante, Vincenzo Giorgio; Frazzoni, Marzio

2015-05-01

Some patients with benign colorectal obstruction do not respond to endoscopic balloon dilation. Fully covered self-expandable metal stents (FCSEMSs) have several potential advantages over non-covered stents, including a higher likelihood of retrieval owing to limited local tissue reaction. However, the efficacy and safety of FCSEMSs in benign colorectal strictures have not yet been established. Retrospective analysis of prospectively collected data concerning patients with post-surgical benign symptomatic anastomotic colorectal strictures, refractory to endoscopic dilation and in whom FCSEMSs had been placed at our center. Technical success was defined as successful stent placement and deployment at the stricture site. Early clinical success was defined as symptom relief persisting at least for 3 days. Follow-up was based on monthly clinical evaluation and quarterly endoscopic assessment. Endoscopic stent removal was planned on the basis of clinical or endoscopic assessment. Prolonged clinical success was defined as persistent symptom relief during follow-up. Technical and early clinical success were obtained in 16 of 16 (100%) patients. The median follow-up was 21 months. Prolonged clinical success was achieved in 9/16 (56%) cases. There was no major complication, including perforation and bleeding. Stent migration occurred in 3 (19%) cases, in two of them associated with clinical failure. The median stent diameter was significantly higher in patients with successful than in those with unsuccessful clinical outcome (26 vs. 20 mm, P = 0.006). The clinical success rate was 1/6 (17%) in patients who received a 20-22 mm stent and 8/10 (80%) in those who received a 24-26 mm stent, respectively (P = 0.035). FCSEMSs can represent effective and safe treatment for refractory anastomotic colorectal strictures. Large diameter stents are warranted for better results.

Comparison between uncovered and covered self-expandable metal stent placement in malignant duodenal obstruction.

PubMed

Kim, Ji Won; Jeong, Ji Bong; Lee, Kook Lae; Kim, Byeong Gwan; Ahn, Dong Won; Lee, Jae Kyung; Kim, Su Hwan

2015-02-07

To compare the clinical outcomes of uncovered and covered self-expandable metal stent placements in patients with malignant duodenal obstruction. A total of 67 patients were retrospectively enrolled from January 2003 to June 2013. All patients had symptomatic obstruction characterized by nausea, vomiting, reduced oral intake, and weight loss. The exclusion criteria included asymptomatic duodenal obstruction, perforation or peritonitis, concomitant small bowel obstruction, or duodenal obstruction caused by benign strictures. The technical and clinical success rate, complication rate, and stent patency were compared according to the placement of uncovered (n = 38) or covered (n = 29) stents. The technical and clinical success rates did not differ between the uncovered and covered stent groups (100% vs 96.6% and 89.5% vs 82.8%). There were no differences in the overall complication rates between the uncovered and covered stent groups (31.6% vs 41.4%). However, stent migration occurred more frequently with covered than uncovered stents [20.7% (6/29) vs 0% (0/38), P < 0.05]. Moreover, the overall cumulative median duration of stent patency was longer in uncovered than in covered stents [251 d (95%CI: 149.8 d-352.2 d) vs 139 d (95%CI: 45.5 d-232.5 d), P < 0.05 by log-rank test] The overall cumulative median survival period was not different between the uncovered stent (70 d) and covered stent groups (60 d). Uncovered stents may be preferable in malignant duodenal obstruction because of their greater resistance to stent migration and longer stent patency than covered stents.

Comparison between uncovered and covered self-expandable metal stent placement in malignant duodenal obstruction

PubMed Central

Kim, Ji Won; Jeong, Ji Bong; Lee, Kook Lae; Kim, Byeong Gwan; Ahn, Dong Won; Lee, Jae Kyung; Kim, Su Hwan

2015-01-01

AIM: To compare the clinical outcomes of uncovered and covered self-expandable metal stent placements in patients with malignant duodenal obstruction. METHODS: A total of 67 patients were retrospectively enrolled from January 2003 to June 2013. All patients had symptomatic obstruction characterized by nausea, vomiting, reduced oral intake, and weight loss. The exclusion criteria included asymptomatic duodenal obstruction, perforation or peritonitis, concomitant small bowel obstruction, or duodenal obstruction caused by benign strictures. The technical and clinical success rate, complication rate, and stent patency were compared according to the placement of uncovered (n = 38) or covered (n = 29) stents. RESULTS: The technical and clinical success rates did not differ between the uncovered and covered stent groups (100% vs 96.6% and 89.5% vs 82.8%). There were no differences in the overall complication rates between the uncovered and covered stent groups (31.6% vs 41.4%). However, stent migration occurred more frequently with covered than uncovered stents [20.7% (6/29) vs 0% (0/38), P < 0.05]. Moreover, the overall cumulative median duration of stent patency was longer in uncovered than in covered stents [251 d (95%CI: 149.8 d-352.2 d) vs 139 d (95%CI: 45.5 d-232.5 d), P < 0.05 by log-rank test] The overall cumulative median survival period was not different between the uncovered stent (70 d) and covered stent groups (60 d). CONCLUSION: Uncovered stents may be preferable in malignant duodenal obstruction because of their greater resistance to stent migration and longer stent patency than covered stents. PMID:25663777

Mechanical behavior of polymer-based vs. metallic-based bioresorbable stents

PubMed Central

Ang, Hui Ying; Huang, Ying Ying; Lim, Soo Teik; Wong, Philip; Joner, Michael

2017-01-01

Bioresorbable scaffolds (BRS) were developed to overcome the drawbacks of current metallic drug-eluting stents (DES), such as late in-stent restenosis and caging of the vessel permanently. The concept of the BRS is to provide transient support to the vessel during healing before being degraded and resorbed by the body, freeing the vessel and restoring vasomotion. The mechanical properties of the BRS are influenced by the choice of the material and processing methods. Due to insufficient radial strength of the bioresorbable material, BRS often required large strut profile as compared to conventional metallic DES. Having thick struts will in turn affect the deliverability of the device and may cause flow disturbance, thereby increasing the incidence of acute thrombotic events. Currently, the bioresorbable poly-l-lactic acid (PLLA) polymer and magnesium (Mg) alloys are being investigated as materials in BRS technologies. The bioresorption process, mechanical properties, in vitro observations and clinical outcomes of PLLA-based and Mg-based BRS will be examined in this review. PMID:28894598

Long-term results of permanent metallic stent implantation in the treatment of benign upper urinary tract occlusion.

PubMed

Li, Xun; He, Zhaohui; Yuan, Jian; Zeng, Guohua; He, Yongzhong; Lei, Ming

2007-08-01

The management of complicated benign upper urinary tract occlusion is extremely challenging, especially in patients unable to undergo an open operative procedure. We report the long-term results of a permanent metallic stent for benign upper urinary tract occlusion. From October 1995 to December 1998, 13 patients (8 men and 5 women, with a mean age of 43 years) with benign upper tract occlusion have been treated by metallic stent implantation. All patients had a nephrostomy tube to relieve the obstruction and the average time of the nephrostomy tube stay was 27 months, ranging from 3 to 131 months. The average length of occlusion was 2.7 cm, ranging from 1 to 3.6 cm. Ultrasonography, urography, diuresis renography and urine culture were performed every 3 months after stent insertion. Ureteroscopy was done when needed. The mean follow-up was 92 months (12-132 months). Ureteral patency was achieved in six patients and assisted patency with a Double-J stent was achieved in three patients. In two patients the kidney had to be removed because of progressive malfunction and in two patients the metal stent had to be extracted with the Holmium: YAG laser, burning it down due to the uncontrollable pyonephrosis. In three patients the ipsilateral flank pain recurred. One of these patients experienced urine leakage due to the initial nephrostomy tract: a ureteroscopy revealed a complete hyperplastic urothelial response. Proximal stone formations were found in 2 patients and all were removed by percutaneous nephrolithotomy (PCNL). No stent migration or fragmentation was observed. The implantation of metal stent is a safe and effective treatment for benign upper urinary tract occlusion, and has satisfying long-term outcome in selected cases. A further investigation is needed for its impact on the urodynamics of upper urinary tract.

Efficacy of laser photoablative therapy and expandable metal stents for esophageal carcinoma

NASA Astrophysics Data System (ADS)

Balachandar, Gowra; Trowers, Eugene A.

2000-05-01

Malignant dysphagia is a serious condition in which 70% of patients die within one year, regardless of the treatment received. It provokes a rapid deterioration of a patient's physical condition and a significant worsening of quality of life. The surgical treatment of dysphagia is frequently complicated with technical difficulties, and often the tumors cannot be excised because of extensive invasion into adjacent structures. Furthermore, many patients are considered inoperable due to advanced age, associated diseases and malnutrition. Laser photoablative therapy coupled with expandable metal stents restores luminal patency in more than 80% of patients allowing them to eat liquids and soft foods. The efficacy of laser photoablative therapy and expandable metal stents for the palliation esophageal carcinoma will be critically reviewed.

Dilatation by Soehendra stent retriever is feasible and effective in multiple deployment of metallic stents to malignant hilar biliary strictures.

PubMed

Kato, Hironari; Kawamoto, Hirofumi; Noma, Yasuhiro; Sonoyama, Takayuki; Tsutsumi, Koichiro; Fujii, Masakuni; Okada, Hiroyuki; Yamamoto, Kazuhide

2013-01-01

The endoscopic management of malignant hilar biliary strictures using multiple metallic stents (MS) is technically demanding, in the initial deployment of MS and the recovery from MS occlusion with deployment of multiple plastic stents (PS). We evaluated the outcomes of the application of a Soehendra stent retriever (SSR) as a dilator of intractable strictures. Fifty-nine patients with malignant hilar biliary strictures had multiple MS inserted using a partial stent-in-stent procedure. When we encountered intractable strictures, we adopted SSR to dilate the stricture and the interstice of the MS. We evaluated the success rate of MS or PS deployment after SSR application and procedural complications. Five of 59 patients (8%) were subjected to SSR application for the initial MS deployment. MS were successfully deployed in all of these patients (100%). MS occlusion was noted in 27 patients. We applied SSR to seven patients (26%) for the deployment of multiple PS after MS occlusion. In five patients (71%), successful PS deployment was achieved after the SSR application. No complications related to dilatation using SSR occurred in any patient. SSR proved to be a potent dilator of difficult strictures in the management of malignant hilar biliary strictures.

Late migration of a metal stent after EUS-drainage of a pancreatic pseudocyst abscess.

PubMed

Maldonado Pérez, Belén; Guerra Veloz, María Fernanda; Romero Castro, Rafael

2018-04-01

Endoscopic ultrasound (EUS)-guided drainage of pancreatic collections has replaced surgery as the first line of treatment due its accuracy and safety profile. A higher success rate and fewer adverse events has been observed using fully covered metal stent for the drainage. However, complications of EUS-guided drainage can appear. We present a case of late migration of the stent.

Customized Hinged Covered Metallic Stents for the Treatment of Benign Main Bronchial Stenosis.

PubMed

Han, Xinwei; Al-Tariq, Quazi; Zhao, Yanle; Li, Lei; Cheng, Zhe; Wang, Huaqi; Liu, Chao; Jiao, Dechao; Wu, Gang

2017-08-01

To address the limitations of silicone stents, we designed a hinged self-expandable covered metallic stent. The aim of this study was to evaluate the safety and efficacy of the customized stents in clinical applications. This was a retrospective analysis. Under conscious sedation and local anesthesia, the stents were implanted or removed by interventional radiologists, with fluoroscopic guidance. Of 24 patients with benign main bronchial stenosis, stents were successfully placed in 21 (87.5%). The low-pressure balloon before dilation failed in 1 case (4.17%) of left main bronchial cicatricial stenosis. In 2 other cases (8.33%), stent placement was abandoned. Stents were successfully removed between 29 and 103 days after the procedure. After stent removal, the follow-up lasted for at least 12 months. Restenosis occurred only in 1 case (4.55%) owing to bronchial collapse 3 days after stent removal. Dyspnea occurred in another case (4.55%) at 2 months after retrieval; recurrence was confirmed using bronchoscopy, leading to a left pneumonectomy. The described procedure is safe and easy to be performed and avoids the use of intubation, bronchoscopy, and general anesthesia. Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

High-Resolution C-Arm CT and Metal Artifact Reduction Software: A Novel Imaging Modality for Analyzing Aneurysms Treated with Stent-Assisted Coil Embolization.

PubMed

Yuki, I; Kambayashi, Y; Ikemura, A; Abe, Y; Kan, I; Mohamed, A; Dahmani, C; Suzuki, T; Ishibashi, T; Takao, H; Urashima, M; Murayama, Y

2016-02-01

Combination of high-resolution C-arm CT and novel metal artifact reduction software may contribute to the assessment of aneurysms treated with stent-assisted coil embolization. This study aimed to evaluate the efficacy of a novel Metal Artifact Reduction prototype software combined with the currently available high spatial-resolution C-arm CT prototype implementation by using an experimental aneurysm model treated with stent-assisted coil embolization. Eight experimental aneurysms were created in 6 swine. Coil embolization of each aneurysm was performed by using a stent-assisted technique. High-resolution C-arm CT with intra-arterial contrast injection was performed immediately after the treatment. The obtained images were processed with Metal Artifact Reduction. Five neurointerventional specialists reviewed the image quality before and after Metal Artifact Reduction. Observational and quantitative analyses (via image analysis software) were performed. Every aneurysm was successfully created and treated with stent-assisted coil embolization. Before Metal Artifact Reduction, coil loops protruding through the stent lumen were not visualized due to the prominent metal artifacts produced by the coils. These became visible after Metal Artifact Reduction processing. Contrast filling in the residual aneurysm was also visualized after Metal Artifact Reduction in every aneurysm. Both the observational (P < .0001) and quantitative (P < .001) analyses showed significant reduction of the metal artifacts after application of the Metal Artifact Reduction prototype software. The combination of high-resolution C-arm CT and Metal Artifact Reduction enables differentiation of the coil mass, stent, and contrast material on the same image by significantly reducing the metal artifacts produced by the platinum coils. This novel image technique may improve the assessment of aneurysms treated with stent-assisted coil embolization. © 2016 by American Journal of Neuroradiology.

Fully covered Alimaxx esophageal metal stents in the endoscopic treatment of benign esophageal diseases.

PubMed

Senousy, Bahaa E; Gupte, Anand R; Draganov, Peter V; Forsmark, Chris E; Wagh, Mihir S

2010-12-01

Expandable esophageal stents are widely used for the palliation of dysphagia in patients with esophageal cancer and are also beginning to be used in patients with benign esophageal diseases such as refractory strictures and fistulas. There is concern regarding the increased risk of migration of the fully covered Alimaxx metal esophageal stent and experience with this stent in benign esophageal pathology has been reported in only a small series of patients. To evaluate the technical success in placement and removal, efficacy and complications of the Alimaxx esophageal stent for benign esophageal diseases. Our endoscopy database was retrospectively reviewed from 1/2003 to 2/2009 to identify patients with Alimaxx esophageal stent placement for benign diseases. Chart review was performed for age, gender, indication, site of the lesion, success of placement, outcome, and incidence of complications. Twenty-eight stents were successfully placed in 14 patients with benign esophageal diseases (mean: two stents/patient; range 1-7). Indications included esophageal fistula in seven (50%) and benign strictures in 7/14 (50%). Dysphagia improved in all patients while the fistula resolved in 6/7 (85.8%) patients. Complications related to stents included pain (2/28, 7%), stent related gastric ulcer (1/28, 4%), nausea and vomiting (3/21, 11%) and stent migration (11/28, 39%). All migrated stents were successfully endoscopically retrieved. The fully covered and removable Alimaxx stent is effective in the endoscopic management of benign esophageal strictures or fistulas, despite its relatively high rate of migration. Stent migration was successfully managed endoscopically without complications.

Temporary placement of retrievable fully covered metallic stents versus percutaneous balloon dilation in the treatment of benign biliary strictures.

PubMed

Kim, Jin Hyoung; Gwon, Dong Il; Ko, Gi-Young; Sung, Kyu-Bo; Lee, Sung Koo; Yoon, Hyun-Ki; Shin, Ji Hoon; Song, Ho-Young

2011-06-01

To compare retrospectively percutaneous transhepatic primary placement of a retrievable self-expanding metallic stent with percutaneous balloon dilation for the treatment of benign biliary strictures. From 2005-2009, 66 patients with benign biliary strictures in whom an endoscopic approach failed or in whom such an approach was inaccessible were evaluated. Of 66 patients, 31 underwent balloon dilation, and 35 underwent temporary metallic stent placement. The etiologies of the benign strictures were anastomotic stricture after surgery (n = 54), stricture secondary to intraoperative injury (n = 9), inflammatory stricture (n = 2), and stricture secondary to trauma (n = 1). The primary patency rates were significantly better in the stent group (87% at 3 years) than in the balloon group (44% at 3 years; P = .022). The indwelling period of percutaneous transhepatic biliary drainage (PTBD) catheters after the initial procedure was able to be significantly reduced in the stent group (median 2.5 months) compared with the balloon group (median 4.5 months; P = .001). Significant bleeding (associated with PTBD) occurred in one patient in the balloon group. In the stent group, stent migration occurred in two patients, and one patient underwent surgery for stent removal after failure of removal under fluoroscopic guidance. Percutaneous primary placement of a retrievable self-expanding metallic stent showed superior intermediate-term results compared with percutaneous balloon dilation for the treatment of benign biliary strictures. In addition, the indwelling period of PTBD catheters can be significantly reduced using temporary stent placement. Copyright © 2011 SIR. Published by Elsevier Inc. All rights reserved.

Endovascular Gene Delivery from a Stent Platform: Gene- Eluting Stents

PubMed Central

Fishbein, Ilia; Chorny, Michael; Adamo, Richard F; Forbes, Scott P; Corrales, Ricardo A; Alferiev, Ivan S; Levy, Robert J

2015-01-01

A synergistic impact of research in the fields of post-angioplasty restenosis, drug-eluting stents and vascular gene therapy over the past 15 years has shaped the concept of gene-eluting stents. Gene-eluting stents hold promise of overcoming some biological and technical problems inherent to drug-eluting stent technology. As the field of gene-eluting stents matures it becomes evident that all three main design modules of a gene-eluting stent: a therapeutic transgene, a vector and a delivery system are equally important for accomplishing sustained inhibition of neointimal formation in arteries treated with gene delivery stents. This review summarizes prior work on stent-based gene delivery and discusses the main optimization strategies required to move the field of gene-eluting stents to clinical translation. PMID:26225356

Long-term Outcome of Short Metallic Stents for Lobar Airway Stenosis.

PubMed

Fruchter, Oren; Abed El Raouf, Bayya; Rosengarten, Dror; Kramer, Mordechai R

2017-07-01

Whereas stents are considered an excellent treatment for proximal central major airway stenosis, the value of stenting for distal lobar airway stenosis is still controversial. Our aim was to explore the short-term and long-term outcome of metallic stents placed for benign and malignant lobar airway stenosis. Between July 2007 and July 2014, 14 patients underwent small airway stent insertion. The clinical follow-up included serial semiannual physical examinations, pulmonary function tests, imaging, and bronchoscopy. The etiologies for airway stenosis were: early post-lung transplantation bronchial stenosis (N=5), sarcoidosis (N=1), amyloidosis (N=1), anthracofibrosis (N=1), right middle lobe syndrome due to external lymph node compression (N=1), lung cancer (N=4), and stenosis of the left upper lobe of unknown etiology (N=1). Stents were placed in the right upper lobe bronchus (N=2), right middle lobe bronchus (N=6), left upper lobe bronchus (N=4), linguar bronchus (N=1), and left lower lobe bronchus (N=1). The median follow-up period ranged from 2 to 72 months (median 18 mo). Immediate relief of symptoms was achieved in the vast majority of patients (13/14, 92%). Out of 10 patients with benign etiology for stenosis, 9 (90%) experienced sustained and progressive improvement in pulmonary function tests and clinical condition. We describe our positive experience with small stents for lobar airway stenosis; further prospective trials are required to evaluate the value of this novel modality of treatment.

Use of a balloon-expandable metallic stent for treatment of nasopharyngeal stenosis in dogs and cats: six cases (2005-2007).

PubMed

Berent, Allyson C; Weisse, Chick; Todd, Kimberly; Rondeau, Mark P; Reiter, Alexander M

2008-11-01

To determine outcome associated with use of a balloon-expandable metallic stent for treatment of nasopharyngeal stenosis in dogs and cats. Retrospective case series. 3 dogs and 3 cats. All 6 animals had severe inspiratory stertor at initial examination. Two animals had no orifice present at the stenosis. Nasopharyngeal stenosis was diagnosed and stent size determined by use of computed tomography. A percutaneous transluminal angioplasty balloon premounted with a balloon-expandable metallic stent was placed over a guidewire, advanced through the stenotic lesion under fluoroscopic and rhinoscopic guidance, and dilated to restore patency. All animals had immediate resolution of clinical signs after stent placement. The procedure took a median of 38 minutes (range, 22 to 70 minutes). One animal with a stenosis located far caudally needed the tip of the stent resected because of hairball entrapment and exaggerated swallowing. Both animals without an orifice in the stenosis had tissue in-growth requiring a covered stent. All animals were reexamined 6 to 12 weeks after treatment via rhinoscopy, radiography, computed tomography, or a combination of techniques. All animals lacked signs of discomfort; 5 of 6 were breathing normally 12 to 28 months after the procedure. Transnasal balloon-expandable metallic stent placement may represent a rapid, safe, noninvasive, and effective treatment in animals with nasopharyngeal stenosis. If the stenosis is extremely caudal in the nasopharynx, serial balloon dilatation might be considered prior to stent placement. A covered stent should be considered initially if the stenosis is completely closed.

Improvement of quality of life and survival using self-expandable metal stent placement for severe malignant stenosis of the gastric body: a case report.

PubMed

Kumagai, Hozumi; Nio, Kenta; Shirakawa, Tsuyoshi; Uchino, Keita; Kusaba, Hitoshi; Isobe, Taichi; Komoda, Masato; Tamura, Shingo; Maeyama, Ryo; Nagai, Eishi; Akashi, Koichi; Baba, Eishi

2012-09-19

Advanced gastric carcinoma often decreases quality of life because of upper gastrointestinal tract stenosis. Self-expandable metal stents have been thought to be an effective, minimally invasive treatment for stenosis. However, the effectiveness of self-expandable metal stent placement for carcinomatous stenosis of the gastric body and antrum has not been clarified, and there have been few reports of such cases. A 74-year-old Japanese woman developed stenosis of the gastric body and antrum caused by advanced gastric cancer during first-line chemotherapy. She developed weight loss and poor nutrition due to inadequate intake. Self-expandable metal stent placement for stenosis of the gastric body and antrum ameliorated her symptoms rapidly and improved her general condition and quality of life. Eight days after self-expandable metal stent placement, second-line chemotherapy could be administered safely. Oral intake and nutritional status were maintained for 117 days after self-expandable metal stent placement, and she died of gastric cancer 176 days after self-expandable metal stent placement and initiation of second-line chemotherapy. Self-expandable metal stent placement for carcinomatous stenosis in the gastric body and antrum could be an effective therapeutic strategy for patients with inadequate oral uptake. It may provide rapid improvement of the patient's general condition and oral intake with minimal complications, comparatively long-term symptom relief, and a survival benefit by allowing second-line chemotherapy.

Outcomes with various drug eluting or bare metal stents in patients with diabetes mellitus: mixed treatment comparison analysis of 22 844 patient years of follow-up from randomised trials

PubMed Central

Kumar, Sunil; Fusaro, Mario; Amoroso, Nicholas; Kirtane, Ajay J; Byrne, Robert A; Williams, David O; Slater, James; Cutlip, Donald E; Feit, Frederick

2012-01-01

Objectives To evaluate the efficacy and safety of currently used drug eluting stents compared with each other and compared with bare metal stents in patients with diabetes. Design Mixed treatment comparison meta-analysis. Data sources and study selection PubMed, Embase, and CENTRAL were searched for randomised clinical trials, until April 2012, of four durable polymer drug eluting stents (sirolimus eluting stents, paclitaxel eluting stents, everolimus eluting stents, and zotarolimus eluting stents) compared with each other or with bare metal stents for the treatment of de novo coronary lesions and enrolling at least 50 patients with diabetes. Primary outcomes Efficacy (target vessel revascularisation) and safety (death, myocardial infarction, stent thrombosis). Results From 42 trials with 22 844 patient years of follow-up, when compared with bare metal stents (reference rate ratio 1) all of the currently used drug eluting stents were associated with a significant reduction in target vessel revascularisation (37% to 69%), though the efficacy varied with the type of stent (everolimus eluting stents∼sirolimus eluting stents>paclitaxel eluting stents∼zotarolimus eluting stent>bare metal stents). There was about an 87% probability that everolimus eluting stents were the most efficacious compared with all others, though there were limited usable data for the zotarolimus eluting Resolute stent in patients with diabetes. Moreover, there was no increased risk of any safety outcome (including very late stent thrombosis) with any drug eluting stents compared with bare metal stents. There was about a 62% probability that the everolimus eluting stent was the safest stent for the outcome of “any” stent thrombosis. Conclusions Among patients with diabetes treated with coronary stents all currently available drug eluting stents were efficacious without compromising safety compared with bare metal stents. There were relative differences among the drug eluting stents, such

Expandable stents.

PubMed

Nesbitt, J C; Carrasco, H

1996-05-01

Expandable metallic stents are effective in selected patients with malignant or benign airway stenoses. When used for malignant lesions, the primary purpose of the stent is to improve the quality of life; stents are usually chosen for palliation of symptoms in recognition of the low likelihood of success for other therapy. For patients with benign stenoses, the stents provide a permanent source of structural support to alleviate the narrowed segment. The advantages of the expandable metallic stents are as follows: (1) they can be inserted through an endotracheal tube or under local anesthesia with relative simplicity under fluoroscopic guidance; (2) they do not impair the drainage of sputum because ciliary movement is not interrupted; (3) over a period of a few weeks, the meshwork is gradually covered with mucosa as the stent becomes incorporated into the airway wall; (4) ventilation usually is not impaired if the metallic mesh stent covers another nonstenosed bronchus, because the interstices of the stent are nonobstructive; and (5) they are dynamic and continue to expand over time, particularly if concurrent treatment achieves an effect on the lesion that caused stenosis. Disadvantages of the expandable stent include (1) they often are only temporarily effective for tracheobronchial stenosis due to intraluminal tumor or granulation tissue, both of which can grow between the wires; (2) they are considered permanent stents because removal is difficult; and (3) they can be poorly positioned during placement or can become displaced by progressive migration after placement, and they cannot be repositioned. A relative contraindication to insertion is an inflammatory process or infection that can predispose to granulation formation, particularly at the points of maximal contact pressure of the stent to the airway mucosa. In the presence of inflammation, it may be better to use a silicone prosthesis until the inflammatory process subsides and fibrosis occurs. Granulation

Endoscopic bilateral stent-in-stent placement for malignant hilar obstruction using a large cell type stent.

PubMed

Park, Jin Myung; Lee, Sang Hyub; Chung, Kwang Hyun; Jang, Dong Kee; Ryu, Ji Kon; Kim, Yong-Tae; Lee, Jae Min; Paik, Woo Hyun

2016-12-01

Bilateral stent-in-stent (SIS) self-expandable metal stent placement is technically challenging for palliation of unresectable malignant hilar obstruction. In the SIS technique, the uniform large cell type biliary stent facilitates contralateral stent deployment through the mesh of the first metallic stent. This study aimed to assess the technical success and clinical effectiveness of this technique with a uniform large cell type biliary stent. Thirty-one patients who underwent bilateral SIS placement using a large cell type stent were reviewed retrospectively. All patients showed malignant hilar obstruction (Bismuth types II, III, IV) with different etiologies. Sixteen (51.6%) patients were male. The mean age of the patients was 67.0+/-14.0 years. Most patients were diagnosed as having hilar cholangiocarcinoma (58.1%) and gallbladder cancer (29.0%). Technical success rate was 83.9%. Success was achieved more frequently in patients without masses obstructing the biliary confluence (MOC) than those with MOC (95.2% vs 60.0%, P=0.03). Functional success rate was 77.4%. Complications occurred in 29.0% of the patients. These tended to occur more frequently in patients with MOC (50.0% vs 19.0%, P=0.11). Median time to recurrent biliary obstruction was 188 days and median survival was 175 days. The large cell type stent can be used efficiently for bilateral SIS placement in malignant hilar obstruction. However, the risk of technical failure increases in patients with MOC, and caution is needed to prevent complications for these patients.

Partially covered self-expandable metal stents versus polyethylene stents for malignant biliary obstruction: A cost-effectiveness analysis

PubMed Central

Barkun, Alan N; Adam, Viviane; Martel, Myriam; AlNaamani, Khalid; Moses, Peter L

2015-01-01

BACKGROUND/OBJECTIVE: Partially covered self-expandable metal stents (SEMS) and polyethylene stents (PES) are both commonly used in the palliation of malignant biliary obstruction. Although SEMS are significantly more expensive, they are more efficacious than PES. Accordingly, a cost-effectiveness analysis was performed. METHODS: A cost-effectiveness analysis compared the approach of initial placement of PES versus SEMS for the study population. Patients with malignant biliary obstruction underwent an endoscopic retrograde cholangiopancreatography to insert the initial stent. If the insertion failed, a percutaneous transhepatic cholangiogram was performed. If stent occlusion occurred, a PES was inserted at repeat endoscopic retrograde cholangiopancreatography, either in an outpatient setting or after admission to hospital if cholangitis was present. A third-party payer perspective was adopted. Effectiveness was expressed as the likelihood of no occlusion over the one-year adopted time horizon. Probabilities were based on a contemporary randomized clinical trial, and costs were issued from national references. Deterministic and probabilistic sensitivity analyses were performed. RESULTS: A PES-first strategy was both more expensive and less efficacious than an SEMS-first approach. The mean per-patient costs were US$6,701 for initial SEMS and US$20,671 for initial PES, which were associated with effectiveness probabilities of 65.6% and 13.9%, respectively. Sensitivity analyses confirmed the robustness of these results. CONCLUSION: At the time of initial endoscopic drainage for patients with malignant biliary obstruction undergoing palliative stenting, an initial SEMS insertion approach was both more effective and less costly than a PES-first strategy. PMID:26125107

Transhepatic metallic stenting for hepaticojejunostomy stricture following laparoscopic cholecystectomy biliary injury: A case of successful 20 years follow-up

PubMed Central

Donatelli, Gianfranco; Mutter, Didier; Dhumane, Parag; Callari, Cosimo; Marescaux, Jacques

2012-01-01

Laparoscopic cholecystectomy is still associated with a considerable rate of biliary injuries and related strictures. Advances in interventional endoscopy and percutaneous techniques have made stenting a preferred treatment modality for the management of these strictures. We report successful 20 years of follow-up of a case of trans-hepatic metallic stenting (2 Gianturco® prostheses, 5 cm long, 2 cm in diameter) done for stenosed hepatico-jejunostomy anastomosis after laparoscopic CBD injury. Percutaneous transhepatic stenting and long-term placement of metallic stents need to be re-evaluated as a minimally invasive definitive treatment option for benign biliary strictures in patients with altered anatomy such as hepatico-jejunostomy or in whom re-operation involves high risk. PMID:22837599

Transhepatic metallic stenting for hepaticojejunostomy stricture following laparoscopic cholecystectomy biliary injury: A case of successful 20 years follow-up.

PubMed

Donatelli, Gianfranco; Mutter, Didier; Dhumane, Parag; Callari, Cosimo; Marescaux, Jacques

2012-07-01

Laparoscopic cholecystectomy is still associated with a considerable rate of biliary injuries and related strictures. Advances in interventional endoscopy and percutaneous techniques have made stenting a preferred treatment modality for the management of these strictures. We report successful 20 years of follow-up of a case of trans-hepatic metallic stenting (2 Gianturco(®) prostheses, 5 cm long, 2 cm in diameter) done for stenosed hepatico-jejunostomy anastomosis after laparoscopic CBD injury. Percutaneous transhepatic stenting and long-term placement of metallic stents need to be re-evaluated as a minimally invasive definitive treatment option for benign biliary strictures in patients with altered anatomy such as hepatico-jejunostomy or in whom re-operation involves high risk.

Self-expandable metallic stent placement plus laparoscopy for acute malignant colorectal obstruction.

PubMed

Zhou, Jia-Min; Yao, Li-Qing; Xu, Jian-Min; Xu, Mei-Dong; Zhou, Ping-Hong; Chen, Wei-Feng; Shi, Qiang; Ren, Zhong; Chen, Tao; Zhong, Yun-Shi

2013-09-07

To investigate the clinical advantages of the stent-laparoscopy approach to treat colorectal cancer (CRC) patients with acute colorectal obstruction (ACO). From April 2008 to April 2012, surgery-related parameters, complications, overall survival (OS), and disease-free survival (DFS) of 74 consecutive patients with left-sided CRC presented with ACO who underwent self-expandable metallic stent (SEMS) placement followed by one-stage open (n = 58) or laparoscopic resection (n = 16) were evaluated retrospectively. The stent-laparoscopy group was also compared with a control group of 96 CRC patients who underwent regular laparoscopy without ACO between January 2010 and December 2011 to explore whether SEMS placement influenced the laparoscopic procedure or reduced long-term survival by influencing CRC oncological characteristics. The characteristics of patients among these groups were comparable. The rate of conversion to open surgery was 12.5% in the stent-laparoscopy group. Bowel function recovery and postoperative hospital stay were significantly shorter (3.3 ± 0.9 d vs 4.2 ± 1.5 d and 6.7 ± 1.1 d vs 9.5 ± 6.7 d, P = 0.016 and P = 0.005), and surgical time was significantly longer (152.1 ± 44.4 min vs 127.4 ± 38.4 min, P = 0.045) in the stent-laparoscopy group than in the stent-open group. Surgery-related complications and the rate of admission to the intensive care unit were lower in the stent-laparoscopy group. There were no significant differences in the interval between stenting and surgery, intraoperative blood loss, OS, and DFS between the two stent groups. Compared with those in the stent-laparoscopy group, all surgery-related parameters, complications, OS, and DFS in the control group were comparable. The stent-laparoscopy approach is a feasible, rapid, and minimally invasive option for patients with ACO caused by left-sided CRC and can achieve a favorable long-term prognosis.

Use of drug-eluting stents versus bare-metal stents in Korea: a cost-minimization analysis using population data.

PubMed

Suh, Hae Sun; Song, Hyun Jin; Jang, Eun Jin; Kim, Jung-Sun; Choi, Donghoon; Lee, Sang Moo

2013-07-01

The goal of this study was to perform an economic analysis of a primary stenting with drug-eluting stents (DES) compared with bare-metal stents (BMS) in patients with acute myocardial infarction (AMI) admitted through an emergency room (ER) visit in Korea using population-based data. We employed a cost-minimization method using a decision analytic model with a two-year time period. Model probabilities and costs were obtained from a published systematic review and population-based data from which a retrospective database analysis of the national reimbursement database of Health Insurance Review and Assessment covering 2006 through 2010 was performed. Uncertainty was evaluated using one-way sensitivity analyses and probabilistic sensitivity analyses. Among 513 979 cases with AMI during 2007 and 2008, 24 742 cases underwent stenting procedures and 20 320 patients admitted through an ER visit with primary stenting were identified in the base model. The transition probabilities of DES-to-DES, DES-to-BMS, DES-to-coronary artery bypass graft, and DES-to-balloon were 59.7%, 0.6%, 4.3%, and 35.3%, respectively, among these patients. The average two-year costs of DES and BMS in 2011 Korean won were 11 065 528 won/person and 9 647 647 won/person, respectively. DES resulted in higher costs than BMS by 1 417 882 won/person. The model was highly sensitive to the probability and costs of having no revascularization. Primary stenting with BMS for AMI with an ER visit was shown to be a cost-saving procedure compared with DES in Korea. Caution is needed when applying this finding to patients with a higher level of severity in health status.

Influence of strut cross-section of stents on local hemodynamics in stented arteries

NASA Astrophysics Data System (ADS)

Jiang, Yongfei; Zhang, Jun; Zhao, Wanhua

2016-05-01

Stenting is a very effective treatment for stenotic vascular diseases, but vascular geometries altered by stent implantation may lead to flow disturbances which play an important role in the initiation and progression of restenosis, especially in the near wall in stented arterial regions. So stent designs have become one of the indispensable factors needed to be considered for reducing the flow disturbances. In this paper, the structural designs of strut cross-section are considered as an aspect of stent designs to be studied in details. Six virtual stents with different strut cross-section are designed for deployments in the same ideal arterial model. Computational fluid dynamics (CFD) methods are performed to study how the shape and the aspect ratio (AR) of strut cross-section modified the local hemodynamics in the stented segments. The results indicate that stents with different strut cross-sections have different influence on the hemodynamics. Stents with streamlined cross-sectional struts for circular arc or elliptical arc can significantly enhance wall shear stress (WSS) in the stented segments, and reduce the flow disturbances around stent struts. The performances of stents with streamlined cross-sectional struts are better than that of stents with non-streamlined cross-sectional struts for rectangle. The results also show that stents with a larger AR cross-section are more conductive to improve the blood flow. The present study provides an understanding of the flow physics in the vicinity of stent struts and indicates that the shape and AR of strut cross-section ought to be considered as important factors to minimize flow disturbance in stent designs.

Combined Arterial Infusion and Stent Implantation Compared with Metal Stent Alone in Treatment of Malignant Gastroduodenal Obstruction

DOE Office of Scientific and Technical Information (OSTI.GOV)

Wang Zhongmin, E-mail: wzm0722@hotmail.co; Chen Kemin, E-mail: ckm0722@hotmail.co; Gong Ju

Many patients with malignant gastroduodenal obstruction have an unresectable primary lesion and distant metastases, which may prompt palliative management to allow the patient to eat and to improve the quality of life. Intraluminal metallic stent implantation (MSI) under fluoroscopic guidance has been reported to be an effective option for symptomatic relief in these patients, with a good safety record. An alternative, dual interventional therapy (DIT), has been used during the last decade, in which prosthesis insertion is followed by intra-arterial chemotherapy via the tumor-feeding arteries. The aim of this study was to compare success rates, complication rates, and survival timemore » between MSI and DIT in patients who presented with gastroduodenal obstruction from advanced upper gastrointestinal tract cancer. All consecutive patients with malignant gastroduodenal obstruction seen at our center between October 2002 and August 2007 were retrospectively studied. Patients were treated palliatively by either MSI or DIT by the patient's or the next of kin's decision. Outcomes included technical and clinical success, complication rates, and survival. Of the 164 patients with malignant gastric and duodenal outlet obstructions, 80 (49%) underwent stent insertion as the primary therapy, while the remaining 84 (51%) received DIT. Clinical characteristics were similar between the two groups. In the MSI cohort initial stent implantation was successful in 73 patients (91%), two stents were used in 5 patients, and delayed additional stent insertion for stent obstruction related to tumor overgrowth was required in 3 patients during follow-up. In the DIT cohort the technical success rate was 94%, 3 patients required two stents, and stent obstruction occurred in 2 patients after initial stent placement. Early postprocedural clinical success, indicated by average dysphagia score, improved significantly in both groups: MSI group, from 4.56 to 1.51 (P < 0.01); and DIT group

Percutaneous unilateral biliary metallic stent placement in patients with malignant obstruction of the biliary hila and contralateral portal vein steno-occlusion.

PubMed

Son, Rak Chae; Gwon, Dong Il; Ko, Heung Kyu; Kim, Jong Woo; Ko, Gi-Young

2015-01-01

To investigate the outcomes of percutaneous unilateral metallic stent placement in patients with a malignant obstruction of the biliary hila and a contralateral portal vein steno-occlusion. Sixty patients with a malignant hilar obstruction and unilobar portal vein steno-occlusion caused by tumor invasion or preoperative portal vein embolization were enrolled in this retrospective study from October 2010 to October 2013. All patients were treated with percutaneous placement of a biliary metallic stent, including expanded polytetrafluoroethylene (ePTFE)-covered stents in 27 patients and uncovered stents in 33 patients. A total of 70 stents were successfully placed in 60 patients. Procedural-related minor complications, including self-limiting hemobilia (n = 2) and cholangitis (n = 4) occurred in six (10%) patients. Acute cholecystitis occurred in two patients. Successful internal drainage was achieved in 54 (90%) of the 60 patients. According to a Kaplan-Meier analysis, median survival time was 210 days (95% confidence interval [CI], 135-284 days), and median stent patency time was 133 days (95% CI, 94-171 days). No significant difference in stent patency was observed between covered and uncovered stents (p = 0.646). Stent dysfunction occurred in 16 (29.6%) of 54 patients after a mean of 159 days (range, 65-321 days). Unilateral placement of ePTFE-covered and uncovered stents in the hepatic lobe with a patent portal vein is a safe and effective method for palliative treatment of patients with a contralateral portal vein steno-occlusion caused by an advanced hilar malignancy or portal vein embolization. No significant difference in stent patency was detected between covered and uncovered metallic stents.

Percutaneous Unilateral Biliary Metallic Stent Placement in Patients with Malignant Obstruction of the Biliary Hila and Contralateral Portal Vein Steno-Occlusion

PubMed Central

Son, Rak Chae; Ko, Heung Kyu; Kim, Jong Woo; Ko, Gi-Young

2015-01-01

Objective To investigate the outcomes of percutaneous unilateral metallic stent placement in patients with a malignant obstruction of the biliary hila and a contralateral portal vein steno-occlusion. Materials and Methods Sixty patients with a malignant hilar obstruction and unilobar portal vein steno-occlusion caused by tumor invasion or preoperative portal vein embolization were enrolled in this retrospective study from October 2010 to October 2013. All patients were treated with percutaneous placement of a biliary metallic stent, including expanded polytetrafluoroethylene (ePTFE)-covered stents in 27 patients and uncovered stents in 33 patients. Results A total of 70 stents were successfully placed in 60 patients. Procedural-related minor complications, including self-limiting hemobilia (n = 2) and cholangitis (n = 4) occurred in six (10%) patients. Acute cholecystitis occurred in two patients. Successful internal drainage was achieved in 54 (90%) of the 60 patients. According to a Kaplan-Meier analysis, median survival time was 210 days (95% confidence interval [CI], 135-284 days), and median stent patency time was 133 days (95% CI, 94-171 days). No significant difference in stent patency was observed between covered and uncovered stents (p = 0.646). Stent dysfunction occurred in 16 (29.6%) of 54 patients after a mean of 159 days (range, 65-321 days). Conclusion Unilateral placement of ePTFE-covered and uncovered stents in the hepatic lobe with a patent portal vein is a safe and effective method for palliative treatment of patients with a contralateral portal vein steno-occlusion caused by an advanced hilar malignancy or portal vein embolization. No significant difference in stent patency was detected between covered and uncovered metallic stents. PMID:25995688

Fully covered self-expandable metal stent in tracheobronchial disorders: clinical experience.

PubMed

Marchese, Roberto; Poidomani, Grazia; Paglino, Giuseppe; Crimi, Claudia; Lo Nigro, Chiara; Argano, Vincenzo

2015-01-01

The third-generation fully covered self-expandable metallic stent (SEMS) has been developed to solve the problems of difficult removal and in-stent granuloma formation related to the uncovered or partially covered type. There are few written reports about the performance of this type of stents with early encouraging results. To report and analyse our experience with the Silmet® stent in the management of malignant and benign tracheobronchial disorders. We retrospectively reviewed medical records of patients who underwent fully covered SEMS Silmet placement at the Interventional Pulmonology Unit, La Maddalena Cancer Center, Palermo, Italy, between May 2010 and August 2013. Stents were placed in 52 patients with malignant (n = 49) and benign airway obstruction (n = 2) and broncho-oesophageal fistula (n = 1). SEMSs were inserted into the trachea (n = 19), the main bronchi (n = 21) and the peripheral bronchi (n = 31). Besides 1 procedural dislocation, the deployment was successful in all patients with an immediate significant improvement of symptoms (Barthel Index p < 0.001; Medical Research Council score p < 0.001). A radiographic improvement was detected in 48% of patients. The mean follow-up duration was 119 ± 120 days (range 22-549 days). Complications observed were: migration (7.6%), tumour overgrowth (15%), infections (5.7%), granulation tissue formation (3.8%) and mucus plug (3.8%). The Silmet stent is effective, safe and simple to implant and remove. We suggest its use in cases of tight stenoses, in the treatment of small- to medium-caliber airways or in cases of tortuous airways. © 2015 S. Karger AG, Basel.

Palliative treatment with radiation-emitting metallic stents in unresectable Bismuth type III or IV hilar cholangiocarcinoma.

PubMed

Lu, Jian; Guo, Jin-He; Zhu, Hai-Dong; Zhu, Guang-Yu; Wang, Yong; Zhang, Qi; Chen, Li; Wang, Chao; Pan, Tian-Fan; Teng, Gao-Jun

2017-01-01

The emerging data for stenting in combination with brachytherapy in unresectable hilar cholangiocarcinoma are encouraging. The aim of this study was to evaluate the efficacy and safety of radiation-emitting metallic stents (REMS) for unresectable Bismuth type III or IV hilar cholangiocarcinoma. Consecutive patients who underwent percutaneous placement with REMS or uncovered self-expandable metallic stent (SEMS) for unresectable Bismuth type III or IV hilar cholangiocarcinoma between September 2011 and April 2016 were identified into this retrospective study. Data on patient demographics and overall survival, functional success, stent patency and complications were collected at the authors' hospital. A total of 59 patients were included: 33 (55.9%) in the REMS group and 26 (44.1%) in the SEMS group. The median overall survival was 338 days in the REMS group and 141 days in the SEMS group (p<0.001). The median stent patency time was 385 days for REMS and 142 days for SEMS (p<0.001). The functional success rate (87.9% vs 84.6%, p=0.722) and incidence of overall complications (27.3% vs 26.9%, p=0.999) did not differ in the two groups. Placement with REMS is safe and effective in palliation for unresectable Bismuth type III or IV hilar cholangiocarcinoma, and seems to prolong survival as well as patency of stent in these patients.

Comparison of the SYNERGY with the PROMUS (XIENCE V) and bare metal and polymer-only Element control stents in porcine coronary arteries.

PubMed

Wilson, Gregory J; Huibregtse, Barbara A; Pennington, Douglas E; Dawkins, Keith D

2012-06-20

This study evaluated vascular compatibility of the novel platinum chromium alloy Element stent platform delivering abluminal everolimus from a poly-lactide-co-glycolide bioabsorbable polymer (SYNERGY stent), currently undergoing clinical trial, compared with the PROMUS (XIENCE V) and bare metal and polymer-only Element stents. Stents (n=161) were implanted one per coronary artery in 72 swine at a stent-to-artery ratio of 1.1:1. Similar numbers of each device group were explanted at each of 30, 90, 180, and 360 days (except no PROMUS (XIENCE V) stent at 360 days) for pathological analysis. There was no stent thrombosis, myocardial infarction, or strut fractures in any group. Vascular response was similar between the SYNERGY and PROMUS (XIENCE V) stents, with no thrombi and complete endothelialisation on both scanning electron microscopy and histology at 30, 90 and 180 days. There were no significant differences for the morphologic parameters of luminal thrombus, endothelial cell coverage, strut tissue coverage, inflammation, internal elastic lamina (IEL) disruption, external elastic lamina (EEL) disruption and medial smooth muscle cell loss across device groups or between time points, but there was mild but greater (p<0.0001) para-strut fibrin at 30 days for both drug-eluting stents (DES) compared with the bare and polymer-only controls; this difference completely dissipated by 90 days. Inflammation was predominantly minimal to mild for all device types. No morphometric parameters, including intimal thickness, stent profile-based area stenosis, and EEL area were significantly different when comparing the SYNERGY stent with the bare metal Element and polymer-only Element control stents at 90, 180 and 360 days. In this non-injured porcine coronary artery model, the bioabsorbable polymer SYNERGY stent demonstrated vascular compatibility equivalent to the PROMUS (XIENCE V) stent and to the bare metal and polymer-only Element stents.

Fabrication of a silver particle-integrated silicone polymer-covered metal stent against sludge and biofilm formation and stent-induced tissue inflammation

PubMed Central

Lee, Tae Hoon; Jang, Bong Seok; Jung, Min Kyo; Pack, Chan Gi; Choi, Jun-Ho; Park, Do Hyun

2016-01-01

To reduce tissue or tumor ingrowth, covered self-expandable metal stents (SEMSs) have been developed. The effectiveness of covered SEMSs may be attenuated by sludge or stone formation or by stent clogging due to the formation of biofilm on the covering membrane. In this study, we tested the hypothesis that a silicone membrane containing silver particles (Ag-P) would prevent sludge and biofilm formation on the covered SEMS. In vitro, the Ag-P-integrated silicone polymer-covered membrane exhibited sustained antibacterial activity, and there was no definite release of silver ions from the Ag-P-integrated silicone polymer membrane at any time point. Using a porcine stent model, in vivo analysis demonstrated that the Ag-P-integrated silicone polymer-covered SEMS reduced the thickness of the biofilm and the quantity of sludge formed, compared with a conventional silicone-covered SEMS. In vivo, the release of silver ions from an Ag-P-integrated silicone polymer-covered SEMS was not detected in porcine serum. The Ag-P-integrated silicone polymer-covered SEMS also resulted in significantly less stent-related bile duct and subepithelium tissue inflammation than a conventional silicone polymer-covered SEMS. Therefore, the Ag-P-integrated silicone polymer-covered SEMS reduced sludge and biofilm formation and stent-induced pathological changes in tissue. This novel SEMS may prolong the stent patency in clinical application. PMID:27739486

Fabrication of a silver particle-integrated silicone polymer-covered metal stent against sludge and biofilm formation and stent-induced tissue inflammation.

PubMed

Lee, Tae Hoon; Jang, Bong Seok; Jung, Min Kyo; Pack, Chan Gi; Choi, Jun-Ho; Park, Do Hyun

2016-10-14

To reduce tissue or tumor ingrowth, covered self-expandable metal stents (SEMSs) have been developed. The effectiveness of covered SEMSs may be attenuated by sludge or stone formation or by stent clogging due to the formation of biofilm on the covering membrane. In this study, we tested the hypothesis that a silicone membrane containing silver particles (Ag-P) would prevent sludge and biofilm formation on the covered SEMS. In vitro, the Ag-P-integrated silicone polymer-covered membrane exhibited sustained antibacterial activity, and there was no definite release of silver ions from the Ag-P-integrated silicone polymer membrane at any time point. Using a porcine stent model, in vivo analysis demonstrated that the Ag-P-integrated silicone polymer-covered SEMS reduced the thickness of the biofilm and the quantity of sludge formed, compared with a conventional silicone-covered SEMS. In vivo, the release of silver ions from an Ag-P-integrated silicone polymer-covered SEMS was not detected in porcine serum. The Ag-P-integrated silicone polymer-covered SEMS also resulted in significantly less stent-related bile duct and subepithelium tissue inflammation than a conventional silicone polymer-covered SEMS. Therefore, the Ag-P-integrated silicone polymer-covered SEMS reduced sludge and biofilm formation and stent-induced pathological changes in tissue. This novel SEMS may prolong the stent patency in clinical application.

Aspirin Use Is Associated With Reduced Risk of Occlusion of Metallic Biliary Stents.

PubMed

Jang, Sunguk; Stevens, Tyler; Parsi, Mansour A; Lopez, Rocio; Vargo, John J

2017-03-01

Biliary self-expandable metallic stents (SEMSs) are widely used to treat malignant and benign conditions of bile duct. Despite their lower rate of occlusion and longer patency than plastic stents, SEMSs still have significant rates of occlusion. We aimed to identify factors associated with occlusion of biliary SEMS. We performed a retrospective study of consecutive patients who underwent endoscopic retrograde cholangiopancreatography with biliary SEMS placement at the Cleveland Clinic Foundation from March 2011 to April 2016. We collected clinical, endoscopic, radiographic, and surgical data from medical records and performed multivariable analysis to identify factors associated with SEMS patency. Subjects that received minimal daily dose of 81 mg at the time of stent placement until the end of follow-up were assigned to the aspirin exposure group (n = 157) and compared with subjects with no aspirin exposure (n = 436). Patients were followed for a median 81 days. The primary outcome was hazard ratio for SEMS occlusion requiring an interventional maneuver for biliary drainage. We analyzed data from patients receiving a total of 593 biliary SEMS for treatment of malignant and benign conditions of bile duct. Stent occlusion was observed in 126 cases. Multivariable analysis showed that daily use of aspirin (81 mg or more) was associated with 51% lower risk of stent occlusion than in patients without daily use of aspirin (hazard ratio, 0.49; 95% confidence interval, 0.32-0.75). Furthermore, SEMSs had a longer duration of stent patency in patients in the aspirin exposure group (434.4 days) versus the no aspirin exposure group (339.9 days) (P < .001). Stricture location limited to distal bile duct (in comparison with strictures involving proximal extrahepatic duct) was associated with lower risk of stent occlusion (hazard ratio, 0.39; 95% CI, 0.22-0.71). In an analysis of a large cohort of subjects with metallic biliary stent placement for malignant and benign

Medical Devices; Gastroenterology-Urology Devices; Classification of the Metallic Biliary Stent System for Benign Strictures. Final order.

PubMed

2016-07-13

The Food and Drug Administration (FDA) is classifying the metallic biliary stent system for benign strictures into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the metallic biliary stent system for benign strictures' classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

A comparison of outcomes between a lumen-apposing metal stent with electrocautery-enhanced delivery system and a bi-flanged metal stent for drainage of walled-off pancreatic necrosis.

PubMed

Bekkali, Noor L H; Nayar, Manu K; Leeds, John S; Charnley, Richard M; Huggett, Matthew T; Oppong, Kofi W

2017-12-01

 Bi-flanged metal stents (BFMS) have shown promise in the drainage of walled-off pancreatic necrosis (WON), but their placement requires multiple steps and the use of other devices. More recently, a novel device consisting of a combined lumen-apposing metal stent (LAMS) and electrocautery-enhanced delivery system has been introduced. The aim of this study was to compare the placement and outcomes of the two devices.  This was a retrospective review of consecutive patients undergoing endoscopic ultrasound-guided placement of BFMS or LAMS for drainage of symptomatic WON. Data from procedures between October 2012 and December 2016 were taken from a prospectively maintained database. We compared technical and clinical success, procedure time, costs, and composite end point of significant events (adverse events, stent migration, additional percutaneous drainage) between BFMS and LAMS.  72 consecutive patients underwent placement of BFMS (40 patients, 44 stents) or LAMS (32 patients, 33 stents). Technical success was 91 % for BFMS and 97 % for LAMS. Clinical success was 65 % vs. 78 %, respectively. Median in-room procedure time was significantly shorter in the LAMS group (45 minutes [range 30 - 80]) than in the BFMS group (62.5 minutes [range 35 - 135]; P  < 0.001) and fewer direct endoscopic necrosectomies (DEN) were performed (median 1 [0 - 2.0] vs. 2 [0 - 3.7], respectively; P  = 0.005). If only inpatients were considered (35 BFMS and 19 LAMS), there was no significant difference in DEN 2 (range 0 - 11) and 2 (range 0 - 8), respectively. The composite end point of 32 % vs. 24 % was not significantly different. Median procedural costs for all patients with successful stent placement for WON treatment was €4427 (range 1630 - 12 926) for BFMS vs. €3500 (range 2509 - 13 393) for LAMS ( P  = 0.10).  LAMS was superior to BFMS in terms of procedure time, with comparable adverse events, success, and

Metal versus plastic stents for drainage of malignant biliary obstruction before primary surgical resection.

PubMed

Song, Tae Jun; Lee, Jae Hoon; Lee, Sang Soo; Jang, Ji Woong; Kim, Jung Wook; Ok, Tae Jin; Oh, Dong Wook; Park, Do Hyun; Seo, Dong Wan; Lee, Sung Koo; Kim, Myung-Hwan; Kim, Song Cheol; Kim, Chul Nam; Yun, Sung Cheol

2016-11-01

Preoperative biliary drainage (PBD) with stent placement has been commonly used for patients with malignant biliary obstruction. In PBD, the placement of fully covered self-expandable metal stents (FCSEMSs) may provide better patency duration and a lower incidence of cholangitis compared with plastic stents. We aimed to evaluate which type of stent showed better outcomes in PBD. In this multicenter, prospective randomized trial, we compared PBD with FCSEMSs versus plastic stents in 86 patients with malignant biliary obstruction between January 2012 and December 2014. Patients with obstructive jaundice were randomly assigned to undergo PBD either with plastic stents or FCSEMS placement. Baseline characteristics were not significantly different between the 2 groups. Endoscopic stent placement was technically successful in all patients. Procedure-related adverse events were not significantly different between the 2 groups (plastic vs FCSEMS group; 16.3% vs 16.3%, P = 1.0). Reintervention was required in 16.3% of the plastic stent group and 14.0% of the FCSEMS group (P = .763). The interval to surgery after PBD (plastic vs FCSEMS group; 14.2 ± 8.3 vs 12.3 ± 6.9 days, P = .426) was not significantly different between groups. Surgery-related adverse events occurred in 43.6% of the plastic stent group and 40.0% of the FCSEMS group (P = .755). In patients with resectable malignant biliary obstruction, the outcomes of PBD with plastic stents and FCSEMSs were similar. Considering the cost-effectiveness, PBD with plastic stents may be preferable to FCSEMS placement. (Clinical trial registration number: NCT01789502.). Copyright © 2016 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

Chemotherapy versus self-expanding metal stent as primary treatment of severe dysphagia from unresectable oesophageal or gastro-oesophageal junction cancer.

PubMed

Touchefeu, Yann; Archambeaud, Isabelle; Landi, Bruno; Lièvre, Astrid; Lepère, Céline; Rougier, Philippe; Mitry, Emmanuel

2014-03-01

To compare chemotherapy first (group 1) versus self-expanding metal stent first (group 2) for the management of malignant dysphagia in unresectable oesophageal or gastro-oesophageal junction cancer. Patients from two university hospitals with severe malignant dysphagia (dysphagia score ≥ 2) uneligible for surgery or radiochemotherapy were evaluated retrospectively. Forty-two patients were included in group 1, and 29 in group 2. After 4 weeks, dysphagia scores improved by at least 1 point in 67% of patients in group 1 versus 93% in group 2 (p=0.01); 48% of patients in group 1 were able to eat solid food versus 68% in group 2 (p=0.054). In group 1, a self-expanding metal stent was secondarily placed in 18 patients (42.9%), whereas in group 2 dysphagia required a second self-expanding metal stent placement in 33.3% of patients. Chemotherapy as the first treatment may be a valid option, avoiding self-expanding metal stent insertion in half of the patients. Copyright © 2013 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

Y stenting assisted coiling using a new low profile visible intraluminal support device for wide necked basilar tip aneurysms: a technical report.

PubMed

Conrad, Marcelo D; Brasiliense, Leonardo B C; Richie, Alexa N; Hanel, Ricardo A

2014-05-01

Many endovascular techniques have been described in recent years for the management of wide necked aneurysms. The Y stent assisted technique has been generally used for coil embolization of wide necked bifurcation aneurysms. This technique was first described for the treatment of basilar tip aneurysms in combination with several different devices, demonstrating encouraging results. We report the results of the first two cases of wide necked basilar tip aneurysms treated with Y stent assisted coil embolization using a new low profile visible intraluminal stent (LVIS Jr; MicroVention, Tustin, California, USA) delivered through a 0.017 inch microcatheter. We also reviewed the literature comparing other endovascular techniques (coiling alone, stent assisted coiling, and Y stent assisted coiling) for wide necked aneurysms. The LVIS Jr device offers a new option for the treatment of these challenging lesions, with clear advantages over currently available intracranial stents. Larger series and long term results are needed to confirm the applicability and durability of this technique/technology.

Success and complications of an intra-ductal fully covered self-expanding metal stent (ID-FCSEMS) to treat anastomotic biliary strictures (AS) after orthotopic liver transplantation (OLT).

PubMed

Aepli, Patrick; St John, Andrew; Gupta, Saurabh; Hourigan, Luke F; Vaughan, Rhys; Efthymiou, Marios; Kaffes, Arthur

2017-04-01

Anastomotic biliary strictures (AS) after orthotopic liver transplantation (OLT) belong to the most common biliary complications and cause the biggest morbidity burden after OLT. Metal stents for benign biliary strictures are gaining acceptance with many published series. Traditional metal stent designs seem to have poor durability in AS after OLT. Novel intra-ductal stents are showing promise in these strictures. As a result, we designed a special stent with an antimigration waist and a short stent length with a long removal string that rests in the duodenum for easy removal. This is a retrospective multi-centre Australian study of AS after OLT treated with a novel intra-ductal fully covered self-expanding metal stent. From August 2008 to October 2014, records from three liver transplant centres were reviewed. Totally 36 ID-FCSEMS were inserted in 31 cases to treat an AS after OLT. The mean age of the patients was 56 years, and 61 % were male. The mean time of AS presentation after OLT was 20.3 months. Eight out of our 31 patients were previously treated using multiple plastic stenting over time without any success. Treatment with the ID-FCSEMS was performed with an average treatment time of 3.8 months. Stricture resolution was achieved in 100 %. All attempted stents removals were successful without any difficulty. Complications were reported in 6.5 %. It was pleasing that only one case of stent migration (2.8 %) was seen. Follow-up showed seven cases of AS recurrence (24.1 %), and all were treated successfully with repeat ERCP and stenting (some metal, some plastic). This novel ID-FCSEMS has a high clinical success and low complication rate, and in particular, there was only one case of stent migration. As a result, this stent type is preferred to traditional metal stents for treating AS after OLT.

Cost effectiveness of drug-eluting stents as compared with bare metal stents in patients with coronary artery disease.

PubMed

Wisløff, Torbjørn; Atar, Dan; Sønbø Kristiansen, Ivar

2013-01-01

The aim of this study was to estimate the incremental cost effectiveness of replacing bare metal stents (BMS) by drug-eluting stents (DES) when using trial data and registry data. We developed a Markov model (model of cost effectiveness of coronary artery disease) in which 60-year-old patients started by undergoing percutaneous coronary intervention for acute or subacute coronary artery disease. The patients are followed until death or 100 years of age. Data on the occurrence of events (revascularization, acute myocardial infarction, and death) were based on Scandinavian registry data. Separate analyses were conducted with data on effectiveness based on randomized controlled trials and patient registries. On using trial data, it was found that sirolimus-eluting stents (SES) yield 0.003 greater life expectancy and $3300 lower costs than do BMS (dominant strategy). Paclitaxel-eluting stents (PES) yield 0.148 more life years than do SES at additional lifetime costs of $2800 ($21,400 per life year gained). On using registry data, the cost per life year gained was found to be $4900 when replacing BMS with DES. Probabilistic sensitivity analyses, on the other hand, indicate that PES only has a 50%-75% probability of being cost effective, regardless of the type of effectiveness data. DESs are cost effective with current willingness to pay for life year gains. Whether PES or SES is the most effective DES remains uncertain.

Fabrication of Small Caliber Stent-grafts Using Electrospinning and Balloon Expandable Bare Metal Stents.

PubMed

Uthamaraj, Susheil; Tefft, Brandon J; Jana, Soumen; Hlinomaz, Ota; Kalra, Manju; Lerman, Amir; Dragomir-Daescu, Dan; Sandhu, Gurpreet S

2016-10-26

Stent-grafts are widely used for the treatment of various conditions such as aortic lesions, aneurysms, emboli due to coronary intervention procedures and perforations in vasculature. Such stent-grafts are manufactured by covering a stent with a polymer membrane. An ideal stent-graft should have a biocompatible stent covered by a porous, thromboresistant, and biocompatible polymer membrane which mimics the extracellular matrix thereby promoting injury site healing. The goal of this protocol is to manufacture a small caliber stent-graft by encapsulating a balloon expandable stent within two layers of electrospun polyurethane nanofibers. Electrospinning of polyurethane has been shown to assist in healing by mimicking native extracellular matrix, thereby promoting endothelialization. Electrospinning polyurethane nanofibers on a slowly rotating mandrel enabled us to precisely control the thickness of the nanofibrous membrane, which is essential to achieve a small caliber balloon expandable stent-graft. Mechanical validation by crimping and expansion of the stent-graft has shown that the nanofibrous polyurethane membrane is sufficiently flexible to crimp and expand while staying patent without showing any signs of tearing or delamination. Furthermore, stent-grafts fabricated using the methods described here are capable of being implanted using a coronary intervention procedure using standard size guide catheters.

Fabrication of Small Caliber Stent-grafts Using Electrospinning and Balloon Expandable Bare Metal Stents

PubMed Central

Uthamaraj, Susheil; Tefft, Brandon J.; Jana, Soumen; Hlinomaz, Ota; Kalra, Manju; Lerman, Amir; Dragomir-Daescu, Dan; Sandhu, Gurpreet S.

2016-01-01

Stent-grafts are widely used for the treatment of various conditions such as aortic lesions, aneurysms, emboli due to coronary intervention procedures and perforations in vasculature. Such stent-grafts are manufactured by covering a stent with a polymer membrane. An ideal stent-graft should have a biocompatible stent covered by a porous, thromboresistant, and biocompatible polymer membrane which mimics the extracellular matrix thereby promoting injury site healing. The goal of this protocol is to manufacture a small caliber stent-graft by encapsulating a balloon expandable stent within two layers of electrospun polyurethane nanofibers. Electrospinning of polyurethane has been shown to assist in healing by mimicking native extracellular matrix, thereby promoting endothelialization. Electrospinning polyurethane nanofibers on a slowly rotating mandrel enabled us to precisely control the thickness of the nanofibrous membrane, which is essential to achieve a small caliber balloon expandable stent-graft. Mechanical validation by crimping and expansion of the stent-graft has shown that the nanofibrous polyurethane membrane is sufficiently flexible to crimp and expand while staying patent without showing any signs of tearing or delamination. Furthermore, stent-grafts fabricated using the methods described here are capable of being implanted using a coronary intervention procedure using standard size guide catheters. PMID:27805589

Risk factors for covered metallic stent migration in patients with distal malignant biliary obstruction due to pancreatic cancer.

PubMed

Nakai, Yousuke; Isayama, Hiroyuki; Kogure, Hirofumi; Hamada, Tsuyoshi; Togawa, Osamu; Ito, Yukiko; Matsubara, Saburo; Arizumi, Toshihiko; Yagioka, Hiroshi; Mizuno, Suguru; Sasaki, Takashi; Yamamoto, Natsuyo; Hirano, Kenji; Tada, Minoru; Koike, Kazuhiko

2014-09-01

Covered metallic stents (CMSs) were developed to overcome tumor ingrowth in uncovered metallic stents (UMSs) for malignant biliary obstruction, but superiority of CMSs over UMSs is still controversial due to the high migration rate in CMS. Therefore, we conducted this retrospective analysis to clarify risk factors for stent migration, including mechanical properties of CMSs. Patients with unresectable pancreatic cancer, receiving CMS for distal malignant biliary obstruction in five tertiary care centers, were retrospectively studied. Univariate and multivariate analyses to identify prognostic factors for early (< 6 months) stent migration were performed using a proportional hazards model with death or stent occlusion without stent migration as a competing risk. Two mechanical properties were included in the analysis: axial force, the recovery force that leads to a CMS straightening, and radial force (RF), the expansion force against the stricture. Among 290 patients who received CMS placement for distal malignant biliary obstruction, stent migration rate was 15.2%. CMS migrated early (< 6 months) in 10.0% and distally in 11.7%, respectively. In the multivariate analysis, significant risk factors for early stent migration were chemotherapy (subdistribution hazard ratios [SHR] 4.46, P = 0.01), CMS with low RF (SHR 2.23, P = 0.03), and duodenal invasion (SHR 2.25, P = 0.02). CMS with low RF, chemotherapy, and duodenal invasion were associated with CMS migration from our study. © 2014 Journal of Gastroenterology and Hepatology Foundation and Wiley Publishing Asia Pty Ltd.

Pilot study of a novel, large-bore, fully covered self-expandable metallic stent for unresectable distal biliary malignancies.

PubMed

Mukai, Tsuyoshi; Yasuda, Ichiro; Isayama, Hiroyuki; Iwashita, Takuji; Itoi, Takao; Kawakami, Hiroshi; Kogure, Hirofumi; Nakai, Yousuke

2016-09-01

In patients with unresectable malignant distal biliary obstruction, covered self-expandable metallic stents (CSEMS) may remain patent longer than uncovered self-expandable metallic stents as a result of tumor ingrowth prevention. One main cause of recurrent biliary obstruction (RBO) in CSEMS is sludge formation, which can be prevented using a large-bore stent. Therefore, we developed a novel, 12-mm diameter fully covered SEMS (FCSEMS) and investigated its clinical safety, efficacy, and rate of adverse events. This prospective, multicenter pilot study, which ran between June 2011 and November 2012, included 38 consecutive patients with unresectable malignant distal biliary obstruction. All patients underwent endoscopic insertion of our novel stent. Primary endpoint was non-RBO rate 6 months after placement. Technical and functional success rates of the procedures were 100%. Six-month non-RBO rate was 50%, and median time to RBO was 184 days. Median survival time was 241 days. Twelve patients died within 6 months after stent placement without RBO. RBO was observed in 10 patients (26%), with seven experiencing stent occlusion and three experiencing stent migration. Adverse events other than RBO (at <30 days) developed in six patients (16%; cholecystitis, one; pancreatitis, one; hyperamylasemia, one; pancreatic ductitis, one; abdominal pain, two). Stent removal for reintervention was successfully completed in eight patients. Our novel FCSEMS may be safe and effective for managing malignant distal obstruction with an acceptable incidence of adverse events. © 2016 Japan Gastroenterological Endoscopy Society.

Fully covered self-expanding metallic stent placement for benign refractory esophageal strictures.

PubMed

Kahalekar, Vinit; Gupta, Deepak Trilokinath; Bhatt, Pratin; Shukla, Akash; Bhatia, Shobna

2017-05-01

Treatment options for benign refractory esophageal stricture are limited. We retrospectively analyzed data of 11 patients who underwent fully covered self-expanding metallic stent (FC-SEMS) placement for refractory benign esophageal stricture at our institute. Refractory benign esophageal stricture was defined as inability to dilate a stricture to a diameter of 14 mm after a minimum of five sessions at 2-week intervals or inability to maintain diameter of 14 mm for at least 4 weeks. Eleven patients with refractory benign esophageal stricture (corrosive-6, peptic-3, and post-sclerotherapy-2) underwent FC-SEMS placement. The stent was removed after 4-6 weeks as per manufacturer's recommendation. Patients were followed up for 1 year. Three patients with peptic strictures [length of stricture 2, 3, and 3 cm] and two patients with post-sclerotherapy stricture [length 2 and 1.5 cm] had complete response. Two of 6 patients with corrosive stricture (10 cm, 12 cm) developed recurrence of symptoms within 1 month of stent removal, and two after 2 months (8 cm, 3 cm). One patient with corrosive stricture (6 cm) had recurrence after 6 months, and responded to single session of dilatation. One patient with corrosive stricture was asymptomatic for last 12 months. Four stents were migrated. Four patients developed severe retrosternal pain following stent placement, which was managed with analgesics. There were no serious adverse events after placement of stent and removal of stent. Fully covered SEMS is safe and effective for refractory benign non-corrosive esophageal strictures.

Covered Metallic Stents With an Anti-Migration Design vs. Uncovered Stents for the Palliation of Malignant Gastric Outlet Obstruction: A Multicenter, Randomized Trial

PubMed Central

Lee, Hyuk; Min, Byung-Hoon; Lee, Jeong Hoon; Shin, Cheol Min; Kim, Younjoo; Chung, Hyunsoo; Lee, Sang Hyub

2015-01-01

OBJECTIVES: Previous studies reported comparable stent patency between covered self-expandable metallic stents (SEMS) and uncovered SEMS (UCS) for palliation of malignant gastric outlet obstruction (GOO). The aim of this study was to evaluate the efficacy and safety of the newly developed WAVE-covered SEMS (WCS), which has an anti-migration design, compared with UCS in gastric cancer patients with symptomatic GOO. METHODS: A total of 102 inoperable gastric cancer patients with symptomatic GOO were prospectively enrolled from five referral centers and randomized to undergo UCS or WCS placement. Stent patency and recurrence of obstructive symptoms were assessed at 8 weeks and 16 weeks after stent placement. RESULTS: At the 8-week follow-up, both stent patency rates (72.5% vs. 62.7%) and re-intervention rates (19.6% vs. 19.6%) were comparable between the WCS and the UCS groups. Both stent stenosis (2.4% vs. 8.1%) and migration rates (9.5% vs. 5.4%) were comparable between WCS and UCS groups. At the 16-week follow-up, however, the WCS group had a significantly higher stent patency rate than the UCS group (68.6% vs. 41.2%). Re-intervention rates in the WCS and UCS groups were 23.5% and 39.2%, respectively. Compared with the UCS group, the WCS group had a significantly lower stent restenosis rate (7.1% vs. 37.8%) and a comparable migration rate (9.5% vs. 5.4%). Overall stent patency was significantly longer in the WCS group than in the UCS group. No stent-associated significant adverse events occurred in either the WCS or UCS groups. In the multivariate analysis, WCS placement and chemotherapy were identified as independent predictors of 16-week stent patency. CONCLUSIONS: WCS group showed comparable migration rate and significantly more durable long-term stent patency compared with UCS group for the palliation of GOO in patients with inoperable gastric cancer. PMID:26372507

Use of a lumen-apposing metal stent to treat GI strictures (with videos).

PubMed

Irani, Shayan; Jalaj, Sujai; Ross, Andrew; Larsen, Michael; Grimm, Ian S; Baron, Todd H

2017-06-01

Benign GI strictures occur typically in the esophagus and pyloric channel but can occur anywhere in the GI tract and at anastomotic sites. Such strictures can be treated with dilation, incisional therapy, steroid injection, and stents. Our aim was to describe the use of a lumen-apposing metal stent (LAMS) to treat short, benign GI strictures. Consecutive patients who underwent LAMS placement for various benign strictures at 2 tertiary care centers from August 2014 to November 2015 were reviewed retrospectively. The main outcome measures were technical success, clinical success, stent migration, and adverse events. Twenty-five patients (7 males, 18 females) with a median age of 54 years (33-85 years) underwent 28 LAMS placements to treat various benign strictures. The location of the strictures included esophagogastric anastomoses (n=4), gastrojejunal anastomoses (n=13), pylorus (n=6), vertical banded gastroplasty (n=1), and ileocolonic anastomosis (n=1). Twenty patients had been previously treated with dilation alone (9 patients with ≥3 dilations), 11 patients with dilation and steroid injection, 2 patients with additional needle-knife therapy, and 1 patient with placement of a traditional fully covered self-expandable metal stent. A 15-mm internal diameter LAMS was placed in all patients; 3 patients had been treated previously with a 10-mm LAMS. Technical success was achieved in all patients, whereas clinical success was achieved in 15 of 25 patients (60%) who completed a minimum of 6 months of follow-up after placement. Median stent dwell time was 92 days (range, 3-273 days). Stent migration was seen in 2 of 28 stent placements (7%). Four of 25 patients (16%) developed 5 moderate adverse events (pain requiring removal, 2; new stricture formation, 2; bleeding, 1). Median follow-up was 301 days after stent placement. Study limitations include the small, select group of patients, the retrospective study design, and short follow-up. LAMS placement for benign GI

Research of Customized Aortic Stent Graft Manufacture

NASA Astrophysics Data System (ADS)

Zhang, Lei; Chen, Xin; Liu, Muhan

2017-03-01

Thoracic descending aorta diseases include aortic dissection and aortic aneurysm, of which the natural mortality rate is extremely high. At present, endovascular aneurysm repair (EVAR) has been widely used as an effective means for the treatment of descending aortic disease. Most of the existing coating stents are standard design, which are unable to meet the size or structure of different patients. As a result, failure of treatment would be caused by dimensional discrepancy between stent and vessels, which could lead to internal leakage or rupture of blood vessels. Therefore, based on rapid prototyping sacrificial core - coating forming (RPSC-CF), a customized aortic stent graft manufactured technique has been proposed in this study. The aortic stent graft consists of film and metallic stent, so polyether polyurethane (PU) and nickel-titanium (NiTi) shape memory alloy with good biocompatibility were chosen. To minimum film thickness without degrading performance, effect of different dip coating conditions on the thickness of film were studied. To make the NiTi alloy exhibit super-elasticity at body temperature (37°C), influence of different heat treatment conditions on austenite transformation temperature (Af) and mechanical properties were studied. The results show that the customized stent grafts could meet the demand of personalized therapy, and have good performance in blasting pressure and radial support force, laying the foundation for further animal experiment and clinical experiment.

Endoscopic removal of laser-cut covered self-expandable metallic biliary stents: A report of six cases.

PubMed

Tanisaka, Yuki; Ryozawa, Shomei; Kobayashi, Masanori; Harada, Maiko; Kobatake, Tsutomu; Omiya, Kumiko; Iwano, Hirotoshi; Arai, Shin; Nonaka, Kouichi; Mashimo, Yumi

2018-02-01

Covered self-expandable metallic stents (CSEMS) may provide palliative drainage for unresectable distal malignant biliary strictures. Laser-cut CSEMS allows easy positioning due to its characteristic of minimal stent shortening. Endoscopic stent removal is sometimes recommended for recurrent biliary obstruction (RBO). However, there are no previous reports of endoscopic removal of laser-cut CSEMS. The current study presents data from 6 patients who were placed a laser-cut CSEMS for unresectable distal malignant biliary strictures, and later endoscopic stent removal was attempted for RBO at the present institute. The duration of stent placement, the procedural success rate, the procedural duration, and accidental complications were evaluated. The mean duration of stent placement was 156±37.9 days (range, 117-205). The procedural success rate was 100%. The mean procedural duration was 11.8±7.5 min (range, 5-24). No complications were reported. Laser-cut CSEMS were safely removed from all patients. The present case report is the first to demonstrate that Endoscopic stent removal of laser-cut CSEMS was safely performed.

Management of post-gastrectomy anastomosis site obstruction with a self-expandable metallic stent.

PubMed

Cha, Ra Ri; Lee, Sang Soo; Kim, Hyunjin; Kim, Hong Jun; Kim, Tae-Hyo; Jung, Woon Tae; Lee, Ok Jae; Bae, Kyung Soo; Jeong, Sang-Ho; Ha, Chang Yoon

2015-04-28

Post-gastrectomy anastomosis site obstruction is a relatively rare complication after a subtotal gastrectomy. We present a case of a 75-year-old man who underwent a truncal vagotomy, omental patch, gastrojejunostomy, and Braun anastomosis for duodenal ulcer perforation and a gastric outlet obstruction. Following the 10(th) postoperative day, the patient complained of abdominal discomfort and vomiting. We diagnosed post-gastrectomy anastomosis site obstruction by an upper gastrointestinal series and an upper endoscopic examination. We inserted a self-expandable metallic stent (SEMS) at the anastomosis site. The stent was fully expanded after deployment. On the day following the stent insertion, the patient began to eat, and his abdominal discomfort was resolved. This paper describes the successful management of post-gastrectomy anastomosis site obstruction with temporary placement of a SEMS.

Aortobronchial fistula caused by an endobronchial lobar Y stent: a word of caution.

PubMed

Härting, Margarete; Welter, Stefan; Aigner, Clemens

2018-04-25

A 17-year-old female patient with a history of pulmonary tuberculosis was admitted with progressive dyspnoea and haemoptysis. Five months prior to admission, a left bronchial carina Y stent was implanted. Because of the already destroyed parenchyma, a pneumonectomy was planned. Intraoperatively, an aortobronchial fistula was discovered as the source of bleeding, which could be stopped by pledget-armed sutures. The formation of an aortobronchial fistula has to be considered as a potential source of endobronchial bleeding after stent implantation.

[Immediate and Long-term Results of the First in Russia of IntrocoronaryMetal Stent in the Coronary Artery].

PubMed

Babunashvili, A M; Navtsishvili, Z G; Konstantinov, B A

2016-02-01

The authors present immediate and long term results of the first in Russia implantation in coronary artery of Palmaz-Shatz metal stent. Indications for stenting were urgent after complicated dissection as a result of balloon dilation of discrete bifurcational stenosis of anterior interventricular artery (IVA). Immediate angiographic and clinical result was good. At control angiography after 13 years their was no restenosis in stented IVA. However novel narrowing was found in left main coronary artery (LMCA) in which drug eluting stent was implanted. Coronary angiography carried out after 7.5 years after stenting of LMCA and in 20 years after stent implantation in IVA revealed good patency of both stented segments without signs of restenosis. This case report demonstrates possibility of long term preservation of angiographic and clinical effect of staged endovascular treatment of coronary atherosclerosis.

Management of benign biliary strictures with a novel retrievable self-expandable metal stent.

PubMed

Hu, Bing; Leung, Joseph W; Gao, Dao Jian; Wang, Tian Tian; Wu, Jun

2014-03-01

Endoscopic placement of covered self-expandable metal stent (SEMS) has gained popularity in the management of benign biliary strictures (BBS). The existing SEMS has been designed primarily to palliate malignant biliary obstruction and has a high frequency of stent migration, difficulty in retrieval and stricture recurrence after stent removal. This study aimed to design a novel retrievable SEMS dedicated to the treatment of extrahepatic BBS and evaluate its clinical efficacy and safety. A short fully covered SEMS (FCSEMS) with a retrieval lasso was designed for the specific treatment of BBS. A total of 45 patients with segmental extrahepatic BBS were included in this study. The stent was placed entirely inside the bile duct with only the retrieval lasso extending from the papilla. The stents were recommended to be in situ for 6 to 12 months before removal. The FCSEMS was successfully placed in all 45 patients. In all, 33 patients had their FCSEMS successfully removed after a mean period of 8.6 ± 3.7 (range 2-15.5) months. Stent migration occurred in 9.1% of the patients. During a mean follow-up of 18.9 months after stent removal, recurrent stricture was found in 2 (6.1%) patients and was successfully treated with a second FCSEMS. Overall, the strictures resolved in 30/33 (90.9%) patients. Intraductal placement of a short FCSEMS is suitable for the treatment of segmental extrahepatic BBS. This new removable design offered prolonged stenting and drainage for BBS for up to one year with minimal complications. © 2013 Chinese Medical Association Shanghai Branch, Chinese Society of Gastroenterology, Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine and Wiley Publishing Asia Pty Ltd.

Risk factors for technical failure of endoscopic double self-expandable metallic stent placement by partial stent-in-stent method.

PubMed

Kawakubo, Kazumichi; Kawakami, Hiroshi; Toyokawa, Yoshihide; Otani, Koichi; Kuwatani, Masaki; Abe, Yoko; Kawahata, Shuhei; Kubo, Kimitoshi; Kubota, Yoshimasa; Sakamoto, Naoya

2015-01-01

Endoscopic double self-expandable metallic stent (SEMS) placement by the partial stent-in-stent (PSIS) method has been reported to be useful for the management of unresectable hilar malignant biliary obstruction. However, it is technically challenging, and the optimal SEMS for the procedure remains unknown. The aim of this study was to identify the risk factors for technical failure of endoscopic double SEMS placement for unresectable malignant hilar biliary obstruction (MHBO). Between December 2009 and May 2013, 50 consecutive patients with MHBO underwent endoscopic double SEMS placement by the PSIS method. We retrospectively evaluated the rate of successful double SEMS placement and identified the risk factors for technical failure. The technical success rate for double SEMS placement was 82.0% (95% confidence interval [CI]: 69.2-90.2). On univariate analysis, the rate of technical failure was high in patients with metastatic disease and unilateral placement. Multivariate analysis revealed that metastatic disease was a significant risk factor for technical failure (odds ratio: 9.63, 95% CI: 1.11-105.5). The subgroup analysis after double guidewire insertion showed that the rate of technical success was higher in the laser-cut type SEMS with a large mesh and thick delivery system than in the braided type SEMS with a small mesh and thick delivery system. Metastatic disease was a significant risk factor for technical failure of double SEMS placement for unresectable MHBO. The laser-cut type SEMS with a large mesh and thin delivery system might be preferable for the PSIS procedure. © 2014 Japanese Society of Hepato-Biliary-Pancreatic Surgery.

Study of the Behavior of a Bell-Shaped Colonic Self-Expandable NiTi Stent under Peristaltic Movements

PubMed Central

Puértolas, José A.; López, Enrique

2013-01-01

Managing bowel obstruction produced by colon cancer requires an emergency intervention to patients usually in poor conditions, and it requires creating an intestinal stoma in most cases. Regardless of that the tumor may be resectable, a two-stage surgery is mandatory. To avoid these disadvantages, endoscopic placement of self-expanding stents has been introduced more than 10 years ago, as an alternative to relieve colonic obstruction. It can be used as a bridge to elective single-stage surgery avoiding a stoma or as a definitive palliative solution in patients with irresectable tumor or poor estimated survival. Stents must be capable of exerting an adequate radial pressure on the stenosed wall, keeping in mind that stent must not move or be crushed, guaranteeing an adequate lumen when affected by peristaltic waves. A finite element simulation of bell-shaped nitinol stent functionality has been done. Catheter introduction, releasing at position, and the effect of peristaltic wave were simulated. To check the reliability of the simulation, a clinical experimentation with porcine specimens was carried out. The stent presented a good deployment and flexibility. Stent behavior was excellent, expanding from the very narrow lumen corresponding to the maximum peristaltic pressure to the complete recovery of operative lumen when the pressure disappears. PMID:23841067

MRI Artifacts of a Metallic Stent Derived From a Human Aorta Specimen

DOE Office of Scientific and Technical Information (OSTI.GOV)

Soto, M. E.; Flores, P.; Marrufo, O.

Magnetic resonance imaging has proved to be a useful technique to get images of the whole body. However, the presence of ferromagnetic material can cause susceptibility artifacts, which result from microscopic gradients that occur near the boundaries between areas displaying different magnetic susceptibility. These gradients cause dephasing of spins and frequency shifts in the surrounding tissues. Intravoxel dephasing and spatial mis-registration can degrade image quality. An aorta with a metallic stent was preserved in formaldehyde at 10% inside acrylic cylinders and used to obtain MR images. We tested pulsed spin echo and gradient echo sequences to improve image quality. Allmore » experiments were performed on a 7T/21 cm Varian system (Varian, Inc, Palo Alto, CA) equipped with Direct Drive technology and a 16-rung birdcage coil transceiver. The presence of metallic stents produces a lack of signal that might give falsely reassuring appearances within the vessel lumen.« less

Spectral Imaging for Intracranial Stents and Stent Lumen.

PubMed

Weng, Chi-Lun; Tseng, Ying-Chi; Chen, David Yen-Ting; Chen, Chi-Jen; Hsu, Hui-Ling

2016-01-01

Application of computed tomography for monitoring intracranial stents is limited because of stent-related artifacts. Our purpose was to evaluate the effect of gemstone spectral imaging on the intracranial stent and stent lumen. In vitro, we scanned Enterprise stent phantom and a stent-cheese complex using the gemstone spectral imaging protocol. Follow-up gemstone spectral images of 15 consecutive patients with placement of Enterprise from January 2013 to September 2014 were also retrospectively reviewed. We used 70-keV, 140-keV, iodine (water), iodine (calcium), and iodine (hydroxyapatite) images to evaluate their effect on the intracranial stent and stent lumen. Two regions of interest were individually placed in stent lumen and adjacent brain tissue. Contrast-to-noise ratio was measured to determine image quality. The maximal diameter of stent markers was also measured to evaluate stent-related artifact. Two radiologists independently graded the visibility of the lumen at the maker location by using a 4-point scale. The mean of grading score, contrast/noise ratio and maximal diameter of stent markers were compared among all modes. All results were analyzed by SPSS version 20. In vitro, iodine (water) images decreased metallic artifact of stent makers to the greatest degree. The most areas of cheese were observed on iodine (water) images. In vivo, iodine (water) images had the smallest average diameter of stent markers (0.33 ± 0.17mm; P < .05) and showed the highest mean grading score (2.94 ± 0.94; P < .05) and contrast/noise ratio of in-stent lumen (160.03 ±37.79; P < .05) among all the modes. Iodine (water) images can help reduce stent-related artifacts of Enterprise and enhance contrast of in-stent lumen. Spectral imaging may be considered a noninvasive modality for following-up patients with in-stent stenosis.

Drug-eluting stents versus bare-metal stents in saphenous vein grafts: a double-blind, randomised trial.

PubMed

Brilakis, Emmanouil S; Edson, Robert; Bhatt, Deepak L; Goldman, Steven; Holmes, David R; Rao, Sunil V; Shunk, Kendrick; Rangan, Bavana V; Mavromatis, Kreton; Ramanathan, Kodangudi; Bavry, Anthony A; Garcia, Santiago; Latif, Faisal; Armstrong, Ehrin; Jneid, Hani; Conner, Todd A; Wagner, Todd; Karacsonyi, Judit; Uyeda, Lauren; Ventura, Beverly; Alsleben, Aaron; Lu, Ying; Shih, Mei-Chiung; Banerjee, Subhash

2018-05-19

Few studies have examined the efficacy of drug-eluting stents (DES) for reducing aortocoronary saphenous vein bypass graft (SVG) failure compared with bare-metal stents (BMS) in patients undergoing stenting of de-novo SVG lesions. We assessed the risks and benefits of the use of DES versus BMS in de-novo SVG lesions. Patients were recruited to our double-blind, randomised controlled trial from 25 US Department of Veterans Affairs centres. Eligible participants were aged at least 18 years and had at least one significant de-novo SVG lesion (50-99% stenosis of a 2·25-4·5 mm diameter SVG) requiring percutaneous coronary intervention with intent to use embolic protection devices. Enrolled patients were randomly assigned, in a 1:1 ratio, by phone randomisation system to receive a DES or BMS. Randomisation was stratified by presence or absence of diabetes and number of target SVG lesions requiring percutaneous coronary intervention (one or two or more) within each participating site by use of an adaptive scheme intended to balance the two stent type groups on marginal totals for the stratification factors. Patients, referring physicians, study coordinators, and outcome assessors were masked to group allocation. The primary endpoint was the 12-month incidence of target vessel failure, defined as the composite of cardiac death, target vessel myocardial infarction, or target vessel revascularisation. The DIVA trial is registered with ClinicalTrials.gov, number NCT01121224. Between Jan 1, 2012, and Dec 31, 2015, 599 patients were randomly assigned to the stent groups, and the data for 597 patients were used. The patients' mean age was 68·6 (SD 7·6) years, and 595 (>99%) patients were men. The two stent groups were similar for most baseline characteristics. At 12 months, the incidence of target vessel failure was 17% (51 of 292) in the DES group versus 19% (58 of 305) in the BMS group (adjusted hazard ratio 0·92, 95% CI 0·63-1·34, p=0·70). Between-group differences in

Lesion length impacts long term outcomes of drug-eluting stents and bare metal stents differently.

PubMed

Chang, Shang-Hung; Chen, Chun-Chi; Hsieh, Ming-Jer; Wang, Chao-Yung; Lee, Cheng-Hung; Hsieh, I-Chang

2013-01-01

Long lesions have been associated with adverse outcomes in percutaneous coronary interventions with bare metal stents (BMS). However, the exact impact of lesion length on the short- and long-term outcomes of drug-eluting stent (DES) implantations is not as clear. This study compared the impact of lesion length on angiographic and clinical outcomes of BMS and DES in a single-center prospective registry. Lesion length was divided into tertiles. The primary endpoints were angiographically defined binary in-stent restenosis (ISR) rate and major adverse cardiac event (MACE). Of the 4,312 de novo lesions in 3,447 consecutive patients in the CAPTAIN registry, 2,791 lesions (of 2,246 patients) received BMS, and the remaining 1,521 lesions (of 1,201 patients) received DES. The mean follow-up duration was 4.5 years. The longer the lesion, the higher the ISR rate (14%, 18%, and 29%, p<0.001) and the lower the MACE-free survivals (p = 0.007) in the BMS group. However, lesion length showed no such correlation with ISR rates (4.7%, 3.3%, and 7.8%, p = 0.67) or MACE-free survivals (p = 0.19) in the DES group. In our single-center prospective registry, lesion length defined in tertiles has no impact on the short-term (ISR) or long-term (MACE) outcomes of patients implanted with DES. In contrast, longer lesion correlates with higher ISR and MACE rates in BMS group.

A new partially covered metal stent for palliation of malignant dysphagia: a prospective follow-up study.

PubMed

van Boeckel, Petra G; Siersema, Peter D; Sturgess, Richard; Dwyer, Laura; Raijman, Isaac; Hirdes, Meike M; Vleggaar, Frank P

2010-12-01

Metal stents are frequently used for palliation of malignant dysphagia. Recently, a new stent design, the partially covered Wallflex stent (Boston Scientific, Natick, Mass), has been introduced. To determine clinical effectiveness and safety of the esophageal Wallflex stent for the palliation of dysphagia. A prospective follow-up study evaluating a new stent design. Three tertiary-care referral centers. This study involved 37 patients with cancer of the esophagus or gastric cardia. Stent placement. Data were collected regarding technical and clinical outcome, complications, recurrent dysphagia, and survival. A total of 37 patients (median age, 67 years; range, 48-84 years; 22 men [59%]) had a Wallflex stent placed. Stent placement was technically successful in all but 1 patient. Dysphagia improved from a median dysphagia score of 3 (ability to swallow liquids only) to 1 (ability to eat some solid foods) 4 weeks after stent placement. Major complications occurred in 3 patients (8%; pneumonia in 1, severe pain in 2), and 1 patient (3%) died from a complication (pneumonia). Minor complications included mild retrosternal pain in 10 patients (27%) and regurgitation in 7 patients (19%). In total, 8 patients (22%) developed recurrent dysphagia because of stent migration (n = 2 [6%]), food impaction (n = 2 [6%]), or tissue ingrowth or overgrowth (n = 4 [10%]). Nonrandomized study design. Placement of a partially covered Wallflex stent is safe and effective for the palliation of malignant dysphagia, with migration and tissue in- and overgrowth rates comparable to those of similarly designed stents. Retrosternal pain may occur more often with this stent than with other stent designs. Copyright © 2010 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

Randomized trial in malignant biliary obstruction: Plastic vs partially covered metal stents

PubMed Central

Moses, Peter L; AlNaamani, Khalid M; Barkun, Alan N; Gordon, Stuart R; Mitty, Roger D; Branch, M Stanley; Kowalski, Thomas E; Martel, Myriam; Adam, Viviane

2013-01-01

AIM: To compare efficacy and complications of partially covered self-expandable metal stent (pcSEMS) to plastic stent (PS) in patients treated for malignant, infrahilar biliary obstruction. METHODS: Multicenter prospective randomized clinical trial with treatment allocation to a pcWallstent® (SEMS) or a 10 French PS. Palliative patients aged ≥ 18, for infrahilar malignant biliary obstruction and a Karnofsky performance scale index > 60% from 6 participating North American university centers. Primary endpoint was time to stent failure, with secondary outcomes of death, adverse events, Karnofsky performance score and short-form-36 scale administered on a three-monthly basis for up to 2 years. Survival analyses were performed for stent failure and death, with Cox proportional hazards regression models to determine significant predictive characteristics. RESULTS: Eighty-five patients were accrued over 37 mo, 42 were randomized to the SEMS group and 83 patients were available for analyses. Time to stent failure was 385.3 ± 52.5 d in the SEMS and 153.3 ± 19.8 d in the PS group, P = 0.006. Time to death did not differ between groups (192.3 ± 23.4 d for SEMS vs 211.5 ± 28.0 d for PS, P = 0.70). The only significant predictor was treatment allocation, relating to the time to stent failure (P = 0.01). Amongst other measured outcomes, only cholangitis differed, being more common in the PS group (4.9% vs 24.5%, P = 0.029). The small number of patients in follow-up limits longitudinal assessments of performance and quality of life. From an initially planned 120 patients, only 85 patients were recruited. CONCLUSION: Partially covered SEMS result in a longer duration till stent failure without increased complication rates, yet without accompanying measurable benefits in survival, performance, or quality of life. PMID:24379581

Safety and Efficacy of a Fully Covered Self-Expandable Metallic Stent in Benign Airway Stenosis.

PubMed

Fortin, Marc; Lacasse, Yves; Elharrar, Xavier; Tazi-Mezalek, Rachid; Laroumagne, Sophie; Guinde, Julien; Astoul, Philippe; Dutau, Hervé

2017-01-01

The use of self-expandable metallic stents (SEMS) in benign airway disease was the object of a boxed warning from the United States Food and Drug Administration in 2005 due to the risk of stent-related complications and difficulties associated with their removal. Third-generation fully covered SEMS have been commercialized since this warning and theoretically should not present the same difficulties associated with removal as they cannot become embedded in the airway mucosa. We aimed to examine the safety and efficacy of a specific third-generation SEMS, the Silmet stent. We reviewed the records of all patients treated for benign airway stenosis with third-generation Silmet SEMS from January 2011 to December 2015 at the North Hospital of Marseilles, France. Forty SEMS were inserted in 30 patients over this period. Twenty (50.0%) stents were removed because of stent-related complications after a median of 77.0 ± 96.6 days (migration 32.5%, granulation tissue formation 7.5%, subjective intolerance 5.0%, mucus plugging 2.5%, laryngeal edema 2.5%). There were no cases of stent-related mortality. All complications were managed successfully endoscopically. Thirty-six stents (90.0%) were removed successfully after a median of 122.0 ± 113.2 days without any complications. The clinical success rate of stent treatment was 40.7%. Third-generation SEMS are a safe treatment option for complex benign airway stenosis, but complications requiring stent removal are frequent. Further studies are needed to compare the performance of third-generation SEMS and silicone stents in benign airway stenosis. © 2017 S. Karger AG, Basel.

Safety and benefits of self-expandable metallic stents with chemotherapy for malignant gastric outlet obstruction.

PubMed

Miyabe, Katsuyuki; Hayashi, Kazuki; Nakazawa, Takahiro; Sano, Hitoshi; Yamada, Tomonori; Takada, Hiroki; Naitoh, Itaru; Shimizu, Shuya; Kondo, Hiromu; Nishi, Yuji; Yoshida, Michihiro; Umemura, Shuichiro; Hori, Yasuki; Kato, Akihisa; Ohara, Hirotaka; Joh, Takashi

2015-07-01

The influence of chemotherapy on placement of self-expandable metallic stents (SEMS) for malignant gastric outlet obstruction (MGOO) has not been evaluated extensively. We investigated the influence of chemotherapy on the clinical outcomes of SEMS placement for MGOO. A total of 152 cancer patients with MGOO from a university hospital and affiliate hospitals were included. The patients were classified according to chemotherapy status and evaluated for palliative efficacy and safety of SEMS placement. Technical success rate, time to oral intake, and parameters indicating improvement of physical condition did not differ between the with- and without-chemotherapy groups after stent placement. Re-intervention and stent migration were significantly more frequent in the with-chemotherapy group than in the without-chemotherapy group after stent placement (re-intervention, 32.4% vs 7.8%, P = 0.0005; stent migration, 13.5% vs 1.7%, P = 0.0097). The frequency of adverse events did not differ between the with- and without-chemotherapy groups. Although chemotherapy after stent placement was an independent predictive factor for shortening the stent patency period (hazard ratio [HR], 3.10; P = 0.0264), the use of additional stents facilitated uneventful recovery and further prolonged survival time (HR, 0.60; P = 0.0132). Various cancer patients with MGOO can undergo SEMS placement safely regardless of chemotherapy, and concurrent chemotherapy after stent placement can prolong survival time, although re-intervention and stent migration may be increased. © 2015 The Authors. Digestive Endoscopy © 2015 Japan Gastroenterological Endoscopy Society.

Nasojejunal-stent technique (NJST): A new system to prevent fully covered metal stent migration in the treatment of benign esophageal diseases.

PubMed

Hernández Mondragón, Oscar Víctor; Cuellar, Raquel Palos; Murcio Pérez, Enrique

2018-05-19

Fully covered self-expandable metal stents (FCSEMS) have been used for the treatment of benign esophageal conditions such as perforation, leaks, and strictures [1]; high clinical success is reported [2]. Different anchoring methods have been described (clips, suturing devices, over-the-scope clips and Shim technique [2]), because of high migration rates (4-36%) [3,4]. However, not all cases are candidates, mostly in "difficult" cases where enteral feeding is needed [5]. We report the use of the nasojejunal-stent technique (NJST) to prevent migration of FCSEMS in three difficult cases. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Role of stents and laser therapy in biliary strictures

NASA Astrophysics Data System (ADS)

Chennupati, Raja S.; Trowers, Eugene A.

2001-05-01

The most frequent primary cancers causing malignant obstructive jaundice were pancreatic cancer (57%), hilar biliary cancer (19% including metastatic disease), nonhilar biliary cancer (14%) and papillary cancer (10%). Endoscopic stenting has widely replaced palliative surgery for malignant biliary obstruction because of its lower risk and cost. Self-expandable metal stents are the preferred mode of palliation for hilar malignancies. Plastic stents have a major role in benign biliary strictures. Major complications and disadvantages associated with metallic stents include high cost, cholangitis. malposition, migration, unextractability, and breakage of the stents, pancreatitis and stent dysfunction. Dysfunction due to tumor ingrowth can be relieved by thermal methods (argon plasma coagulator therapy). We present a concise review of the efficacy of metallic stents for palliation of malignant strictures.

Electrical potentials between stent-grafts made from different metals induce negligible corrosion.

PubMed

Kazimierczak, A; Podraza, W; Lenart, S; Wiernicki, I; Gutowski, P

2013-10-01

Evaluation of the risk of galvanic corrosion in various stent-grafts in current practice, when devices with unmatched alloy compositions are deployed together. Five nitinol (NT) and two steel (SS) stent-grafts produced by different companies were used in different combinations to create 21 samples (NT:NT, n = 10; NT:SS, n = 10; SS:SS, n = 1). Electric potential was measured between the metal couplings after immersion in 0.9% NaCl at a temperature of 37 °C. Subsequently, the same samples were incubated for 24 months in 0.9% NaCl at 37-39 °C under hermetic conditions and examined under a scanning electron microscope in order to search for any evidence of corrosion. Electric potentials between different metals alloys were found (means: NT:SS, 181 μV; NT:NT, 101 μV; SS:SS, 160 μV). The mean electrical potential between stainless steel and nitinol samples was significantly higher than between NT:NT couplings (p < .001). During the final scanning electron microscope examination, only one spot of pitting corrosion (>10 μm) on a nitinol surface was found (associated with previous mechanical damage) in an NT:SS sample after 24 months of incubation in vitro and no sign of mechanical failure of the wires was found. Direct contact between the stainless steel and the nitinol alloys does indeed create electrical potential but with a minimal risk of galvanic corrosion. No evidence was found for significant galvanic corrosion when two endovascular implants (stent-grafts) made from different metal composition were used in the same procedure. Copyright © 2013 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.

Technical feasibility and revision efficacy of the sequential deployment of endoscopic bilateral side-by-side metal stents for malignant hilar biliary strictures: a multicenter prospective study.

PubMed

Lee, Tae Hoon; Park, Do Hyun; Lee, Sang Soo; Choi, Hyun Jong; Lee, Jun Kyu; Kim, Tae Hyeon; Kim, Jong Hyeok; Jeong, Seok; Park, Sang-Heum; Moon, Jong Ho

2013-02-01

Theoretically, the side-by-side bilateral placement of metal stents may be technically easier than stent-in-stent bilateral placement in stent revision. However, side-by-side placement can be technically challenging, as the deployment of the first stent can preclude the passage of the second stent. We explored the technical feasibility and revision efficacy of endoscopic bilateral side-by-side stent placement for malignant hilar biliary strictures. Forty-four patients with Bismuth type II or higher malignant hilar biliary strictures were enrolled in seven academic tertiary referral centers. Endoscopic placement of side-by-side bilateral metal stents with 7F thin delivery shaft was performed. The outcome measurements were the technical and functional success, adverse events, endoscopic revision success rate, and stent patency. Overall, the technical and functional success rates were 91 % (40/44), and 98 % (39/40), respectively. Two of the failed patients were converted successfully with subsequent contralateral stent-in-stent placement, and the other patients underwent percutaneous intervention. Early stent-related adverse events occurred in 10 %. The endoscopic revision rate due to stent malfunction during follow-up (median: 180 days) was 45 % (18/40; tumor ingrowth in 4 and in-stent sludge impaction/stone formation in 14 patients). The endoscopic revision success rate was 92 % (12/13). Five patients with comorbidity underwent initial percutaneous intervention. The median survival and stent patency periods were 180 and 157 days, respectively. The sequential placement of a metal stent with a 7F thin delivery shaft in bilateral side-by-side procedures may be feasible and effective for malignant hilar biliary strictures and for endoscopic stent revision.

Design Investigation on Applicable Mesh Structures for Medical Stent Applications

NASA Astrophysics Data System (ADS)

Asano, Shoji; He, Jianmei

2017-11-01

In recent years, utilization of medical stents is one of effective treatments for stenosis and occlusion occurring in a living body’s lumen indispensable for maintenance of human life such as superficial femoral artery (SFA) occlusion. However, there are concerns about the occurrence of fatigue fractures caused by stress concentrations, neointimal hyperplasia and the like due to the shape structure and the manufacturing method in the conventional stents, and a stent having high strength and high flexibility is required. Therefore, in this research, applicable mesh structures for medical stents based on the design concepts of high strength, high flexibility are interested to solve various problem of conventional stent. According to the shape and dimensions of SFA occlusion therapy stent and indwelling delivery catheter, shape design of the meshed stent are performed using 3-dimensional CAD software Solid Works first. Then analytical examination on storage characteristics and compression characteristics of such mesh structure applied stent models were carried out through finite element analysis software ANSYS Workbench. Meshed stent models with higher strength and higher flexibility with integral molding are investigated analytically. It was found that the storage characteristics and compression characteristics of meshed stent modles are highly dependent on the basic mesh shapes with same surface void ratio. Trade-off relationship between flexibility and storage characteristics is found exited, it is required to provide appropriate curvatures during basic mesh shape design.

IVUS Findings in Late and Very Late Stent Thrombosis. A Comparison Between Bare-metal and Drug-eluting Stents.

PubMed

Fuentes, Lara; Gómez-Lara, Josep; Salvatella, Neus; Gonzalo, Nieves; Hernández-Hernández, Felipe; Fernández-Nofrerias, Eduard; Sánchez-Recalde, Ángel; Alfonso, Fernando; Romaguera, Rafael; Ferreiro, José Luis; Roura, Gerard; Teruel, Luis; Gracida, Montserrat; Marcano, Ana Lucrecia; Gómez-Hospital, Joan-Antoni; Cequier, Ángel

2018-05-01

Stent thrombosis (ST) is a life-threatening complication after stent implantation. Intravascular ultrasound is able to discern most causes of ST. The aim of this study was to compare intravascular ultrasound findings between bare-metal stents (BMS) and drug-eluting stents (DES) in patients with late (31 days to 1 year) or very late ST (> 1 year). Of 250 consecutive patients with late or very late ST in 7 Spanish institutions, 114 patients (45.5% BMS and 54.5% DES) were imaged with intravascular ultrasound. Off-line intravascular ultrasound analysis was performed to assess malapposition, underexpansion, and neoatherosclerosis. The median time from stent implantation to ST was 4.0 years with BMS and 3.4 years with DES (P = .04). Isolated malapposition was similarly observed in both groups (36.5% vs 46.8%; P = .18) but was numerically lower with BMS (26.6% vs 48.0%; P = .07) in patients with very late ST. Isolated underexpansion was similarly observed in both groups (13.5% vs 11.3%; P = .47). Isolated neoatherosclerosis occurred only in patients with very late ST and was more prevalent with BMS (22.9%) than with DES (6.0%); P = .02. At 2.9 years' follow-up, there were 0% and 6.9% cardiac deaths, respectively (P = .06) and recurrent ST occurred in 4.0% and 5.2% of patients, respectively (P = .60). Malapposition was the most common finding in patients with late and very late ST and is more prevalent with DES in very late ST. In contrast, neoatherosclerosis was exclusively observed in patients with very late ST and mainly with BMS. Copyright © 2017 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

An Update to Hepatobiliary Stents

PubMed Central

Moy, Brian T.; Birk, John W.

2015-01-01

Endoscopic stent placement is a common primary management therapy for benign and malignant biliary strictures. However, continuous use of stents is limited by occlusion and migration. Stent technology has evolved significantly over the past two decades to reduce these problems. The purpose of this article is to review current guidelines in managing malignant and benign biliary obstructions, current endoscopic techniques for stent placement, and emerging stent technology. What began as a simple plastic stent technology has evolved significantly to include uncovered, partially covered, and fully covered self-expanding metal stents (SEMS) as well as magnetic, bioabsorbable, drug-eluting, and antireflux stents.1 PMID:26357636

Airway stents

PubMed Central

Keyes, Colleen

2018-01-01

Stents and tubes to maintain the patency of the airways are commonly used for malignant obstruction and are occasionally employed in benign disease. Malignant airway obstruction usually results from direct involvement of bronchogenic carcinoma, or by extension of carcinomas occurring in the esophagus or the thyroid. External compression from lymph nodes or metastatic disease from other organs can also cause central airway obstruction. Most malignant airway lesions are surgically inoperable due to advanced disease stage and require multimodality palliation, including stent placement. As with any other medical device, stents have significantly evolved over the last 50 years and deserve an in-depth understanding of their true capabilities and complications. Not every silicone stent is created equal and the same holds for metallic stents. Herein, we present an overview of the topic as well as some of the more practical and controversial issues surrounding airway stents. We also try to dispel the myths surrounding stent removal and their supposed use only in central airways. At the end, we come to the long-held conclusion that stents should not be used as first line treatment of choice, but after ruling out the possibility of curative surgical resection or repair. PMID:29707506

Very late stent thrombosis with second generation drug eluting stents compared to bare metal stents: Network meta-analysis of randomized primary percutaneous coronary intervention trials.

PubMed

Philip, Femi; Stewart, Susan; Southard, Jeffrey A

2016-07-01

The relative safety of drug-eluting stents (DES) and bare-metal stents (BMS) in primary percutaneous coronary intervention (PPCI) in ST elevation myocardial infarction (STEMI) continues to be debated. The long-term clinical outcomes between second generation DES and BMS for primary percutaneous coronary intervention (PCI) using network meta-analysis were compared. Randomized controlled trials comparing stent types (first generation DES, second generation DES, or BMS) were considered for inclusion. A search strategy used Medline, Embase, Cochrane databases, and proceedings of international meetings. Information about study design, inclusion criteria, and sample characteristics were extracted. Network meta-analysis was used to pool direct (comparison of second generation DES to BMS) and indirect evidence (first generation DES with BMS and second generation DES) from the randomized trials. Twelve trials comparing all stents types including 9,673 patients randomly assigned to treatment groups were analyzed. Second generation DES was associated with significantly lower incidence of definite or probable ST (OR 0.59, 95% CI 0.39-0.89), MI (OR 0.59, 95% CI 0.39-0.89), and TVR at 3 years (OR 0.50: 95% CI 0.31-0.81) compared with BMS. In addition, there was a significantly lower incidence of MACE with second generation DES versus BMS (OR 0.54, 95% CI 0.34-0.74) at 3 years. These were driven by a higher rate of TVR, MI and stent thrombosis in the BMS group at 3 years. There was a non-significant reduction in the overall and cardiac mortality [OR 0.83, 95% CI (0.60-1.14), OR 0.88, 95% CI (0.6-1.28)] with the use of second generation DES versus BMS at 3 years. Network meta-analysis of randomized trials of primary PCI demonstrated lower incidence of MACE, MI, TVR, and stent thrombosis with second generation DES compared with BMS. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Efficacy and safety of a new fully covered self-expandable non-foreshortening metal esophageal stent.

PubMed

Dua, Kulwinder S; Latif, Sahibzada U; Yang, Juliana F; Fang, Tom C; Khan, Abdul; Oh, Young

2014-10-01

Fully covered esophageal self-expandable metal stents (SEMSs) are potentially removable but can be associated with high migration rates. For precise positioning, non-foreshortening SEMSs are preferred. Recently, a new fully covered non-foreshortening SEMS with anti-migration features was introduced. To evaluate the efficacy and safety of this new esophageal SEMS. Retrospective study. Single, tertiary-care center. Consecutive patients with malignant and benign strictures with dysphagia grade of ≥3 and patients with fistulas/leaks were studied. Stent placement and removal. Technical success in stent deployment/removal, efficacy in relieving dysphagia and sealing fistulas/leaks, and adverse events. Forty-three stents were placed in 35 patients (mean [± standard deviation] age 65 ± 11 years; 31 male), 24 for malignant and 11 for benign (5 strictures, 6 leaks) indications. Technical success in precise SEMS placement was 100%. The after-stent dysphagia grade improved significantly (at 1 week: 1.5 ± 0.7; at 4 weeks: 1.2 ± 0.4; baseline: 3.8 ± 0.4; P < .0001). Twenty stents were removed for clinical indications, with technical success of 100%. All leaks sealed after SEMS placement and did not recur after stent removal. All benign strictures recurred after stent removal. Adverse events included migration (14%), chest pain (11%), and dysphagia from tissue hyperplasia (6%). There was no stent-related mortality. Nonrandomized, single-center study. The new esophageal SEMS was effective in relieving malignant dysphagia, allowed for precise placement, and was easily removable. It was effective in treating benign esophageal fistulas and leaks. Stent-related adverse events were acceptable. Copyright © 2014 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

Clinical outcomes, quality of life, advantages and disadvantages of metal stent placement in the upper gastrointestinal tract.

PubMed

Vlavianos, Panagiotis; Zabron, Abigail

2012-03-01

This review will discuss the immediate- and long-term success, complications and overall benefits of self-expandable metal stents (SEMSs) in malignant or benign obstruction of the oesophagus, stomach and duodenum. Over recent years, indications such as benign disease have expanded, as has SEMS diversity with self-expandable plastic stents (SEPSs) or fully covered and biodegradable stents, for example. SEMSs have been increasingly used in malignant upper gastrointestinal obstruction with many reports confirming efficacy, despite a significant complication rate. Fully covered stents are increasingly used for a variety of benign oesophageal disease, but their place in gastric outlet obstruction is still unclear. Covered and uncovered stents have different functional characteristics and stent type must be selected on an individual basis. Biodegradable stents show promise and the outcome of experience in larger patient cohorts is eagerly awaited. This area is an evolving field, in which the clinician requires up-to-date knowledge of therapeutic options to make individualized treatment choices in difficult clinical circumstances. Technical and clinical success for oesophageal or gastroduodenal SEMSs are then above 90%. Minor complications are common, but serious complications seldom occur. Biodegradable stents may be useful, especially when stenting is needed for a short period of time.

Endoscopic management of unresectable malignant gastroduodenal obstruction with a nitinol uncovered metal stent: A prospective Japanese multicenter study

PubMed Central

Sasaki, Reina; Sakai, Yuji; Tsuyuguchi, Toshio; Nishikawa, Takao; Fujimoto, Tatsuya; Mikami, Shigeru; Sugiyama, Harutoshi; Yokosuka, Osamu

2016-01-01

AIM: To determine the safety and efficacy of endoscopic duodenal stent placement in patients with malignant gastric outlet obstruction. METHODS: This prospective, observational, multicenter study included 39 consecutive patients with malignant gastric outlet obstruction. All patients underwent endoscopic placement of a nitinol, uncovered, self-expandable metal stent. The primary outcome was clinical success at 2 wk after stent placement that was defined as improvement in the Gastric Outlet Obstruction Scoring System score relative to the baseline. RESULTS: Technical success was achieved in all duodenal stent procedures. Procedure-related complications occurred in 4 patients (10.3%) in the form of mild pneumonitis. No other morbidities or mortalities were observed. The clinical success rate was 92.3%. The mean survival period after stent placement was 103 d. The mean period of stent patency was 149 d and the patency remained acceptable for the survival period. Stent dysfunction occurred in 3 patients (7.7%) on account of tumor growth. CONCLUSION: Endoscopic management using duodenal stents for patients with incurable malignant gastric outlet obstruction is safe and improved patients’ quality of life. PMID:27076769

A Zr-based bulk metallic glass for future stent applications: Materials properties, finite element modeling, and in vitro human vascular cell response.

PubMed

Huang, Lu; Pu, Chao; Fisher, Richard K; Mountain, Deidra J H; Gao, Yanfei; Liaw, Peter K; Zhang, Wei; He, Wei

2015-10-01

Despite the prevalent use of crystalline alloys in current vascular stent technology, new biomaterials are being actively sought after to improve stent performance. In this study, we demonstrated the potential of a Zr-Al-Fe-Cu bulk metallic glass (BMG) to serve as a candidate stent material. The mechanical properties of the Zr-based BMG, determined under both static and cyclic loadings, were characterized by high strength, which would allow for the design of thinner stent struts to improve stent biocompatibility. Finite element analysis further complemented the experimental results and revealed that a stent made of the Zr-based BMG was more compliant with the beats of a blood vessel, compared with medical 316L stainless steel. The Zr-based BMG was found to be corrosion resistant in a simulated body environment, owing to the presence of a highly stable ZrO2-rich surface passive film. Application-specific biocompatibility studies were conducted using human aortic endothelial cells and smooth muscle cells. The Zr-Al-Fe-Cu BMG was found to support stronger adhesion and faster coverage of endothelial cells and slower growth of smooth muscle cells than 316L stainless steel. These results suggest that the Zr-based BMG could promote re-endothelialization and potentially lower the risk of restenosis, which are critical to improve vascular stent implantation integration. In general, findings in this study raised the curtain for the potential application of BMGs as future candidates for stent applications. Vascular stents are medical devices typically used to restore the lumen of narrowed or clogged blood vessel. Despite the clinical success of metallic materials in stent-assisted angioplasty, post-surgery complications persist due to the mechanical failures, corrosion, and in-stent restenosis of current stents. To overcome these hurdles, strategies including new designs and surface functionalization have been exercised. In addition, the development of new materials with

Unique usage of a partially covered metal stent for drainage of a pancreatic pseudocyst via endosonography-guided transcystgastrostomy.

PubMed

Nici, Anthony J; Hussain, Syed A; Kim, Sang H; Mehta, Preeti

2012-05-01

Pancreatic pseudocysts are frequent complications of pancreatitis episodes. The current therapeutic modalities for drainage of pancreatic pseudocysts include surgical, percutaneous, and endoscopic drainage modalities. Endosonography-assisted endoscopic drainage of these pseudocysts with the placement of multiple plastic or fully covered self-expanding biliary metal stents is becoming more commonly carried out. The present case report discusses the unique and successful drainage of a pancreatic pseudocyst with the placement of a partially covered self-expanding metal stent. © 2012 The Authors. Digestive Endoscopy © 2012 Japan Gastroenterological Endoscopy Society.

Mechanisms of Biliary Plastic Stent Occlusion and Efforts at Prevention

PubMed Central

Kwon, Chang-Il; Lehman, Glen A.

2016-01-01

Biliary stenting via endoscopic retrograde cholangiopancreatography has greatly improved the quality of patient care over the last 30 years. Plastic stent occlusion limits the life span of such stents. Attempts to improve plastic stent patency duration have mostly failed. Metal stents (self-expandable metal stents [SEMSs]) have therefore replaced plastic stents, especially for malignant biliary strictures. SEMS are at least 10 times more expensive than plastic stents. In this focused review, we will discuss basic mechanisms of plastic stent occlusion, along with a systematic summary of previous efforts and related studies to improve stent patency and potential new techniques to overcome existing limitations. PMID:27000422

Self-Expanding Metal Stents for the Treatment of Post-Surgical Esophageal Leaks: A Tertiary Referral Center Experience.

PubMed

Anderloni, Andrea; Genco, Chiara; Massidda, Marco; Di Leo, Milena; Fumagalli, Uberto Romario; Rosati, Riccardo; Correale, Loredana; Maselli, Roberta; Ferrara, Elisa Chiara; Jovani, Manol; Repici, Alessandro

2018-06-05

The study aimed to evaluate the effectiveness and safety of self-expanding metal stents (SEMS) in the management of post-surgical esophageal leaks. Retrospective data of consecutive patients with a post-surgical esophageal leak treated by means of a metal stent between January 2008 and December 2014 at the Humanitas Research Hospital (Milan, Italy) were extracted from a prospectively maintained register of SEMS used for benign indications, such as post-surgical benign esophageal strictures and/or leaks. The primary outcome of the study was to assess the rate of successful leak closure and to identify the variables associated with its achievement. As a secondary outcome, we evaluated the overall safety of SEMS placement and the efficacy and safety for different types of SEMS in this specific setting of patients. Leak resolution was documented with endoscopic and/or imaging studies. In the case of leak persistence, further attempts of esophageal stenting were carried out at the discretion of both endoscopists and surgeons. A total of 49 patients were included in the study (men 41 of 49, 83.7%, mean age 62.4 ± 11.9). One patient was excluded from analysis, because of death 1 day after stent insertion due to worsening of pre-existing mediastinitis. A total number of 82 stents were placed (mean number of stents per patient: 1.7) in 49 patients: 35 patients (71.4%) received a partially covered SEMS (PCSEMS) as the first stent positioned, while the remaining 14 (28.6%) received a fully covered SEMS (FCSEMS); but 1 patient (2%) died following stent insertion; therefore, data regarding therapeutic success were available for 48 patients. Stents were left in place for a mean period of 21.9 ± 15.2 days. Leak closure after the first stent placement was achieved in 22 of 48 (45.8%) patients. Of the 26 patients with failure of index stent placement, 18 patients underwent further stenting attempts (69.2%), and secondary closure of leak was achieved in 7 (38.9%) of these 18

Biliary hemorrhage after removal of an expandable metallic stent during liver transplantation.

PubMed

Narumi, Shunji; Hakamda, Kenichi; Toyoki, Yoshikazu; Ishido, Keinosuke; Nara, Masaki; Yoshihara, Syuichi; Sasaki, Mutsuo

2008-11-01

The self-expandable metallic stent (SEMS) has become a common device for palliative treatment of malignant biliary obstructions or benign strictures. Despite the ease of placement of SEMSs, their removal has been reported to be very difficult. Here, we report a case with primary sclerosing cholangitis who developed massive hemorrhage after intraoperative removal of a SEMS. Possible living donor liver transplantation (LT) was considered for a 49-year-old female with primary sclerosing cholangitis. However, her general condition did not meet the criteria for LT; therefore, she was referred back to her primary physician. Two years later, she developed jaundice, and her primary physician placed multiple SEMSs, 1 of which was placed across the papilla of Vater. She was evaluated rapidly, and underwent living donor LT. During the operation, the common bile duct was examined and an incision was made. A stent was found firmly embedded in the bile duct. Each wire of the SEMS was pinched and then successfully pulled out 1 by 1. Finally, all parts of the SEMS were removed. Before creating the Roux-en-Y limb, hemorrhage from the remnant bile duct was confirmed by examination of the duodenum and bile duct stump. The bile duct was sewn internally with monofilament stitches and compressed for 10 minutes. Finally, hemostasis was brought about and transplantation was completed successfully. Despite some reports regarding successful endoscopic removal of SEMSs, its removal in patients with portal hypertension coagulopathy is risky. SEMSs should not be placed in patients who are candidates for LT.

Impending rupture of saphenous vein graft aneurysm with floating fractured bare metal stent treated by coil embolization and covered stent implantation.

PubMed

Kodama, Atsuko; Kurita, Tairo; Kato, Osamu; Suzuki, Takahiko

2016-11-01

Aneurysmal degeneration of a saphenous vein graft (SVG) is a rare, but potentially fatal complication of coronary artery bypass graft (CABG) surgery. In this case report, a patient that had undergone prior CABG surgery and bare metal stent (BMS) implantation at the site of a stenotic SVG lesion presented at our hospital with chest pain, and an SVG aneurysm was detected at the previous BMS implantation site. In addition, the implanted BMS was fractured and floating in the SVG aneurysm. The SVG aneurysm was successfully occluded by percutaneous intervention, using a combination of distal covered stent deployment at the site of the anastomosis between the native coronary artery and the SVG and proximal coil embolization of the aneurysm.

Angulated Stents-A Novel Stent Improvisation to Manage Difficult Post-tuberculosis Bronchial Stenosis.

PubMed

Tay, Chee Kiang; Jeong, Byeong-Ho; Kim, Hojoong

2017-10-18

Post-tuberculosis bronchostenosis (PTBS), a complication of endobronchial tuberculosis is currently treated by bronchial stenting. However, in cases of angulated bronchial stenoses, difficulty is often encountered in stent insertion and maintenance, resulting in stent migration, granulation tissue overgrowth, and restenosis. To accommodate the angulated alignment of the stenosis, we devised an "angulated stent"-a novel improvisation of the conventional stent via splicing and suturing to achieve a resultant angulated shape. A retrospective review was undertaken to evaluate the performance of this stent. Among 283 PTBS patients who underwent interventional bronchoscopy at our center from 2004 to 2014, 21 were treated with at least one angulated stent. Clinical outcomes, including the stenting duration were investigated. After a median follow-up of 26 months, stent removal was successful in 7 (33.3%) out of 21 patients. In patients managed with angulated stents, the median duration to stent change or eventual removal was longer than those treated with straight tube stents (392 days vs. 86 days; p < 0.05). Angulated stents are a feasible treatment option in patients with angulated PTBS by reducing complications and prolonging the stent-changing interval.

Comparison of the long-term safety and efficacy of drug-eluting and bare-metal stent implantation in saphenous vein grafts.

PubMed

Latib, Azeem; Ferri, Luca; Ielasi, Alfonso; Cosgrave, John; Godino, Cosmo; Bonizzoni, Erminio; Romagnoli, Enrico; Chieffo, Alaide; Valgimigli, Marco; Penzo, Carlo; Carlino, Mauro; Michev, Iassen; Sangiorgi, Giuseppe M; Montorfano, Matteo; Airoldi, Flavio; Colombo, Antonio

2010-06-01

Concerns about the long-term safety of drug-eluting stents (DES) in saphenous vein grafts has become an area of controversy and uncertainty. In this retrospective registry, we compared the outcomes in 127 patients (143 lesions) treated with DES from April 2002 to June 2006 (DES group) with 131 patients (160 lesions) treated with bare-metal stents in the preceding 36 months (bare-metal stent group). End points analyzed were cumulative death, myocardial infarction, and target vessel revascularization at 2 years after stent implantation. The DES group was significantly (P<0.05) more complex with a greater frequency of diabetes (33.1%versus 15.3%), older grafts (11.6+/-5.3 years versus 9.6+/-5.2 years), restenotic lesions (23.8% versus 4.4%), total occlusions (7.7% versus 1.2%), and smaller grafts (3.16+/-0.66 mm versus 3.44+/-0.76 mm) treated with longer stents (34.1+/-25.1 mm versus 22.7+/-11.6 mm). At 2 years, there was no statistical difference in death (8.7% versus 7.8%), myocardial infarction (6.3% versus 9.4%), or target vessel revascularization (19.7% versus 24.2%) between DES and bare-metal stents, respectively. A propensity analysis to adjust for baseline differences suggested that there was no observed association between DES and increased mortality (hazard ratio, 0.72; 95% CI, 0.21 to 2.44; P=0.60) but possibly an association with a reduction in target vessel revascularization (hazard ratio, 0.31; 95% CI, 0.14 to 0.66; P=0.002). Despite being implanted in patients and lesions more complex than the bare-metal stent group, there was no observed association between DES implantation in saphenous vein grafts and an increase in late mortality. DES may maintain their efficacy in reducing revascularization rates in diseased saphenous vein grafts over a 2-year follow-up period.

Cost-effectiveness of drug-eluting stents versus bare-metal stents in patients undergoing percutaneous coronary intervention.

PubMed

Baschet, Louise; Bourguignon, Sandrine; Marque, Sébastien; Durand-Zaleski, Isabelle; Teiger, Emmanuel; Wilquin, Fanny; Levesque, Karine

2016-01-01

To determine the cost-effectiveness of drug-eluting stents (DES) compared with bare-metal stents (BMS) in patients requiring a percutaneous coronary intervention in France, using a recent meta-analysis including second-generation DES. A cost-effectiveness analysis was performed in the French National Health Insurance setting. Effectiveness settings were taken from a meta-analysis of 117 762 patient-years with 76 randomised trials. The main effectiveness criterion was major cardiac event-free survival. Effectiveness and costs were modelled over a 5-year horizon using a three-state Markov model. Incremental cost-effectiveness ratios and a cost-effectiveness acceptability curve were calculated for a range of thresholds for willingness to pay per year without major cardiac event gain. Deterministic and probabilistic sensitivity analyses were performed. Base case results demonstrated that DES are dominant over BMS, with an increase in event-free survival and a cost-reduction of €184, primarily due to a diminution of second revascularisations, and an absence of myocardial infarction and stent thrombosis. These results are robust for uncertainty on one-way deterministic and probabilistic sensitivity analyses. Using a cost-effectiveness threshold of €7000 per major cardiac event-free year gained, DES has a >95% probability of being cost-effective versus BMS. Following DES price decrease, new-generation DES development and taking into account recent meta-analyses results, the DES can now be considered cost-effective regardless of selective indication in France, according to European recommendations.

[Neoplasic colonic obstruction: resolution with self-expanding metallic stents].

PubMed

Jury, Gastón; Amieva, Leandro; Dolan, Martín; Fagalde, Rafael López; Naiderman, Diego; Pastorino, Martín; Jury, Rubén

2014-03-01

The endoscopic placement of self-expanding metallic stents (SEMS) emerges as a therapeutic option for neoplastic colonic obstruction in two situations: as palliative treatment and as a bridge to surgery. The latter can avoid emergency surgery, thus decreasing the rate of ostomies and the mortality and morbidity associated with them. To evaluate the feasibility, safety and benefits of SEMS placement for the treatment of neoplastic colorectal obstruction. Between August 2008 and June 2012, we included in this prospective, longitudinal, descriptive and observational study all the patients suffering from colorectal neoplasia who were subjected to SEMS placement by the same group ofendoscopists. Nitinol SEMS were inserted under endoscopic vision and radioscopic control. Twenty seven SEMS were inserted in 27 patients, 61% of them were male and the average age was 70 years old. Symptoms of colonic suboclussion or obstruction were found in 92% of patients, 88% of the lesions were located in the left-side colon, 41% of cases were performed on an ambulatory basis and 65% of stenting was carried out for palliative purposes. The average time of hospitalization was 6,46 days. Technical and clinical success were 93% and 100%, respectively. Minor complications were observed in 11% of patients. Colonic stenting was followed by elective surgery within one month, by a laparoscopic technique in most cases. The placement of SEMS arises as a safe and effective alternative to palliative surgery or as a bridge to elective surgery.

Covered versus Uncovered Self-Expandable Metal Stents for Managing Malignant Distal Biliary Obstruction: A Meta-Analysis.

PubMed

Li, Jinjin; Li, Tong; Sun, Ping; Yu, Qihong; Wang, Kun; Chang, Weilong; Song, Zifang; Zheng, Qichang

2016-01-01

To compare the efficacy of using covered self-expandable metal stents (CSEMSs) and uncovered self-expandable metal stents (UCSEMSs) to treat objective jaundice caused by an unresectable malignant tumor. We performed a comprehensive electronic search from 1980 to May 2015. All randomized controlled trials comparing the use of CSEMSs and UCSEMSs to treat malignant distal biliary obstruction were included. The analysis included 1417 patients enrolled in 14 trials. We did not detect significant differences between the UCSEMS group and the CSEMS group in terms of cumulative stent patency (hazard ratio (HR) 0.93, 95% confidence interval (CI) 0.19-4.53; p = 0.93, I2 = 0%), patient survival (HR 0.77, 95% CI 0.05-10.87; p = 0.85, I2 = 0%), overall stent dysfunction (relative ratio (RR) 0.85, M-H, random, 95% CI 0.57-1.25; p = 0.83, I2 = 63%), the overall complication rate (RR 1.26, M-H, fixed, 95% CI 0.94-1.68; p = 0.12, I2 = 0%) or the change in serum bilirubin (weighted mean difference (WMD) -0.13, IV fixed, 95% CI 0.56-0.3; p = 0.55, I2 = 0%). However, we did detect a significant difference in the main causes of stent dysfunction between the two groups. In particular, the CSEMS group exhibited a lower rate of tumor ingrowth (RR 0.25, M-H, random, 95% CI 0.12-0.52; p = 0.002, I2 = 40%) but a higher rate of tumor overgrowth (RR 1.76, M-H, fixed, 95% CI 1.03-3.02; p = 0.04, I2 = 0%). Patients with CSEMSs also exhibited a higher migration rate (RR 9.33, M-H, fixed, 95% CI 2.54-34.24; p = 0.008, I2 = 0%) and a higher rate of sludge formation (RR 2.47, M-H, fixed, 95% CI 1.36-4.50; p = 0.003, I2 = 0%). Our meta-analysis indicates that there is no significant difference in primary stent patency and stent dysfunction between CSEMSs and UCSEMSs during the period from primary stent insertion to primary stent dysfunction or patient death. However, when taking further management for occluded stents into consideration, CSEMSs is a better choice for patients with malignant biliary

Covered versus Uncovered Self-Expandable Metal Stents for Managing Malignant Distal Biliary Obstruction: A Meta-Analysis

PubMed Central

Sun, Ping; Yu, Qihong; Wang, Kun; Chang, Weilong; Song, Zifang; Zheng, Qichang

2016-01-01

Aim To compare the efficacy of using covered self-expandable metal stents (CSEMSs) and uncovered self-expandable metal stents (UCSEMSs) to treat objective jaundice caused by an unresectable malignant tumor. Methods We performed a comprehensive electronic search from 1980 to May 2015. All randomized controlled trials comparing the use of CSEMSs and UCSEMSs to treat malignant distal biliary obstruction were included. Results The analysis included 1417 patients enrolled in 14 trials. We did not detect significant differences between the UCSEMS group and the CSEMS group in terms of cumulative stent patency (hazard ratio (HR) 0.93, 95% confidence interval (CI) 0.19–4.53; p = 0.93, I2 = 0%), patient survival (HR 0.77, 95% CI 0.05–10.87; p = 0.85, I2 = 0%), overall stent dysfunction (relative ratio (RR) 0.85, M-H, random, 95% CI 0.57–1.25; p = 0.83, I2 = 63%), the overall complication rate (RR 1.26, M-H, fixed, 95% CI 0.94–1.68; p = 0.12, I2 = 0%) or the change in serum bilirubin (weighted mean difference (WMD) -0.13, IV fixed, 95% CI 0.56–0.3; p = 0.55, I2 = 0%). However, we did detect a significant difference in the main causes of stent dysfunction between the two groups. In particular, the CSEMS group exhibited a lower rate of tumor ingrowth (RR 0.25, M-H, random, 95% CI 0.12–0.52; p = 0.002, I2 = 40%) but a higher rate of tumor overgrowth (RR 1.76, M-H, fixed, 95% CI 1.03–3.02; p = 0.04, I2 = 0%). Patients with CSEMSs also exhibited a higher migration rate (RR 9.33, M-H, fixed, 95% CI 2.54–34.24; p = 0.008, I2 = 0%) and a higher rate of sludge formation (RR 2.47, M-H, fixed, 95% CI 1.36–4.50; p = 0.003, I2 = 0%). Conclusions Our meta-analysis indicates that there is no significant difference in primary stent patency and stent dysfunction between CSEMSs and UCSEMSs during the period from primary stent insertion to primary stent dysfunction or patient death. However, when taking further management for occluded stents into consideration, CSEMSs is a

Effects of the temporary placement of a self-expandable metallic stent in benign pyloric stenosis.

PubMed

Choi, Won Jae; Park, Jong-Jae; Park, Jain; Lim, Eun-Hye; Joo, Moon Kyung; Yun, Jae-Won; Noh, Hyejin; Kim, Sung Ho; Choi, Woo Seok; Lee, Beom Jae; Kim, Ji Hoon; Yeon, Jong Eun; Kim, Jae Seon; Byun, Kwan Soo; Bak, Young-Tae

2013-07-01

The use of self-expandable metallic stents (SEMS) is an established palliative treatment for malignant stenosis in the gastrointestinal tract; therefore, its application to benign stenosis is expected to be beneficial because of the more gradual and sustained dilatation in the stenotic portion. We aimed in this prospective observational study to evaluate the efficacy and safety of temporary SEMS placement in benign pyloric stenosis. Twenty-two patients with benign stenosis of the prepylorus, pylorus, and duodenal bulb were enrolled and underwent SEMS placement. We assessed symptom improvement, defined as an increase of at least 1 degree in the gastric-outlet-obstruction scoring system after stent insertion. No major complications were observed during the procedures. After stent placement, early symptom improvement was achieved in 18 of 22 patients (81.8%). During the follow-up period (mean 10.2 months), the stents remained in place successfully for 6 to 8 weeks in seven patients (31.8%). Among the 15 patients (62.5%) with stent migration, seven (46.6%) showed continued symptomatic improvement without recurrence of obstructive symptoms. Despite the symptomatic improvement, temporary SEMS placement is premature as an effective therapeutic tool for benign pyloric stenosis unless a novel stent is developed to prevent migration.

Effects of the Temporary Placement of a Self-Expandable Metallic Stent in Benign Pyloric Stenosis

PubMed Central

Choi, Won Jae; Park, Jain; Lim, Eun-Hye; Joo, Moon Kyung; Yun, Jae-Won; Noh, Hyejin; Kim, Sung Ho; Choi, Woo Seok; Lee, Beom Jae; Kim, Ji Hoon; Yeon, Jong Eun; Kim, Jae Seon; Byun, Kwan Soo; Bak, Young-Tae

2013-01-01

Background/Aims The use of self-expandable metallic stents (SEMS) is an established palliative treatment for malignant stenosis in the gastrointestinal tract; therefore, its application to benign stenosis is expected to be beneficial because of the more gradual and sustained dilatation in the stenotic portion. We aimed in this prospective observational study to evaluate the efficacy and safety of temporary SEMS placement in benign pyloric stenosis. Methods Twenty-two patients with benign stenosis of the prepylorus, pylorus, and duodenal bulb were enrolled and underwent SEMS placement. We assessed symptom improvement, defined as an increase of at least 1 degree in the gastric-outlet-obstruction scoring system after stent insertion. Results No major complications were observed during the procedures. After stent placement, early symptom improvement was achieved in 18 of 22 patients (81.8%). During the follow-up period (mean 10.2 months), the stents remained in place successfully for 6 to 8 weeks in seven patients (31.8%). Among the 15 patients (62.5%) with stent migration, seven (46.6%) showed continued symptomatic improvement without recurrence of obstructive symptoms. Conclusions Despite the symptomatic improvement, temporary SEMS placement is premature as an effective therapeutic tool for benign pyloric stenosis unless a novel stent is developed to prevent migration. PMID:23898381

Everolimus-eluting stents in interventional cardiology