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.

[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

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.

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.

Will mesh-covered stents help reduce stroke associated with carotid stent angioplasty?

PubMed

Richards, Carly N; Schneider, Peter A

2017-03-01

Carotid stent angioplasty (CAS) has been shown to protect patient from future stroke long-term efficacy similar to carotid endarterectomy (CEA). The risk of minor stroke in the perioperative period is higher than with CEA and not related to cerebral protection during the CAS procedure since a significant portion of the neurologic events occur between 1 and 30 days following stent deployment. This observation suggests mechanisms integral to the stent itself may be pertinent such as plaque embolization thru the stent struts may occur. It appears that this embolic risk can be reduced by use of specific carotid stent designs that include a mesh covering to minimize the open struts areas and thus embolization through the carotid stent. Improvements in stent design that eliminate post-procedural debris embolization will expand the application of CAS for severe internal carotid artery atherosclerotic stenosis. Copyright © 2017. Published by Elsevier Inc.

[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.

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

Double-layered PTFE-covered nitinol stents: experience in 32 patients with malignant esophageal strictures.

PubMed

Park, Jung Gu; Jung, Gyoo-Sik; Oh, Kyung Seung; Park, Seon-Ja

2010-08-01

We evaluated the effectiveness of a double-layered polytetrafluoroethylene (PTFE)-covered nitinol stent in the palliative treatment of malignant esophageal strictures. A double-layered PTFE-covered nitinol stent was designed to reduce the propensity to migration of conventional covered stent. The stent consists of an inner PTFE-covered stent and an outer uncovered nitinol stent tube. With fluoroscopic guidance, the stent was placed in 32 consecutive patients with malignant esophageal strictures. During the follow-up period, the technical and clinical success rates, complications, and cumulative patient survival and stent patency were evaluated. Stent placement was technically successful in all patients, and no procedural complications occurred. After stent placement, the symptoms of 30 patients (94%) showed improvement. During the mean follow-up of 103 days (range, 9-348 days), 11 (34%) of 32 patients developed recurrent symptoms due to tumor overgrowth in five patients (16%), tumor ingrowth owing to detachment of the covering material (PTFE) apart from the stent wire in 3 (9%), mucosal hyperplasia in 2 (6%), and stent migration in 1 (3%). Ten of these 11 patients were treated by means of placing a second covered stent. Thirty patients died, 29 as a result of disease progression and 1 from aspiration pneumonia. The median survival period was 92 days. The median period of primary stent patency was 190 days. The double-layered PTFE-covered nitinol stent seems to be effective for the palliative treatment of malignant esophageal strictures. We believe that the double-layer configuration of this stent can contribute to decreasing the stent's migration rate.

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

Malignant esophageal-tracheobronchial strictures: parallel placement of covered retrievable expandable nitinol stents.

PubMed

Nam, D H; Shin, J H; Song, H Y; Jung, G S; Han, Y M

2006-02-01

To assess the safety and clinical effectiveness of the parallel placement of covered retrievable expandable metallic stents in the palliative treatment of malignant esophageal and tracheobronchial strictures. Under fluoroscopic guidance, parallel stents were placed in 12 symptomatic patients with both malignant esophageal and tracheobronchial strictures. Seven of these 12 patients also had an esophagorespiratory fistula (ERF) and one patient had an esophagocutaneous fistula. Technical success, clinical improvement, complications, and survival rates were evaluated. A total of 28 esophageal and airway stents were successfully placed. The grade of dysphagia and dyspnea score significantly decreased after stent placement (P=0.002 and 0.003, respectively). ERF and esophagocutaneous fistula were sealed off in all eight patients after esophageal stent placement; however, the esophagocutaneous fistula reopened 1 month later. Complications included stent migration or expectoration (n=3), tracheal compression by the esophageal stent (n=3), new fistula development due to covering membrane degradation of the esophageal stent (n=1), and symptomatic sputum retention (n=1). Stent removal was easily performed for two stents; one migrated stent and the other with covering membrane degradation. All 12 patients died within the mean survival period of 72.50 days (range 7-375 days). Parallel placement of covered retrievable expandable metallic stents is safe and effective for the palliative treatment of malignant esophageal and tracheobronchial strictures.

Comparison of covered versus uncovered wire mesh stents in the canine biliary tract.

PubMed

Silvis, S E; Sievert, C E; Vennes, J A; Abeyta, B K; Brennecke, L H

1994-01-01

Self-expanding wire mesh stents have been developed for endoscopic placement across malignant biliary strictures, but tumor ingrowth may limit the usefulness of open mesh stents. We reasoned that coating the wire mesh might prevent tumor ingrowth. Tissue response to covered and uncovered stents was compared in dogs. Stents were surgically placed in the bile ducts of 22 mongrel dogs through the sphincter of Oddi. Either a silicone-covered stent or an uncovered stent was inserted. Liver function test values remained normal throughout a 1- or 3-month study. Necropsy revealed that all ducts were unobstructed. Bile duct histologic examination revealed mild-to-moderate cellular infiltration in all animals. Mucosal hyperplasia was more marked in the animals with uncovered stents and the bare wires became deeply embedded in bile duct epithelium, whereas the wires of covered stents did not. We conclude that covered stents are well tolerated by the canine bile duct. These results suggest that such stents may be removable, making self-expanding metal stents an appropriate treatment for both benign and malignant biliary strictures.

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.

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

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

Assessment of a Polyester-Covered Nitinol Stent in the Canine Aorta and Iliac Arteries

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

Castaneda, Flavio; Ball-Kell, Susan M.; Young, Kate

Purpose: To evaluate the patency and healing characteristics of a woven polyester fabric-covered stent in the canine model.Methods: Twenty-four self-expanding covered stents were placed in the infrarenal aorta and bilateral common iliac arteries of eight dogs and evaluated at 1 (n = 2), 3 (n = 2), and 6 (n = 4) months. Stent assessment was done using angiography prior to euthanasia, and light and scanning electron microscopy.Results: Angiographically, just prior to euthanasia, 8 of 8 aortic and 14 of 16 iliac endovascular covered stents were patent. Histologically, the stented regions showed complete endothelialization 6 months after graft implantation. Amore » neointima had formed inside the stented vessel regions resulting in complete encasement of the fabric-covered stent by 3 months after graft implantation. Medial compression with smooth muscle cell atrophy was present in all stented regions. Explanted stent wires, examined by scanning electron microscopy, showed pitting but no cracks or breakage.Conclusion: The covered stent demonstrated predictable healing and is effective in preventing stenosis in vessels 10.0 mm or greater in diameter but does not completely preclude stenosis in vessels 6.0 mm or less in diameter.« less

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.

Comparison of Covered Versus Uncovered Stents for Benign Superior Vena Cava (SVC) Obstruction.

PubMed

Haddad, Mustafa M; Simmons, Benjamin; McPhail, Ian R; Kalra, Manju; Neisen, Melissa J; Johnson, Matthew P; Stockland, Andrew H; Andrews, James C; Misra, Sanjay; Bjarnason, Haraldur

2018-05-01

To identify whether long-term symptom relief and stent patency vary with the use of covered versus uncovered stents for the treatment of benign SVC obstruction. We retrospectively identified all patients with benign SVC syndrome treated to stent placement between January 2003 and December 2015 (n = 59). Only cases with both clinical and imaging follow-up were included (n = 47). In 33 (70%) of the patients, the obstruction was due to a central line or pacemaker wires, and in 14 (30%), the cause was fibrosing mediastinitis. Covered stents were placed in 17 (36%) of the patients, and 30 (64%) patients had an uncovered stent. Clinical and treatment outcomes, complications, and the percent stenosis of each stent were evaluated. Technical success was achieved in all cases at first attempt. Average clinical and imaging follow-up in years was 2.7 (range 0.1-11.1) (covered) and 1.7 (range 0.2-10.5) (uncovered), respectively. There was a significant difference (p = 0.044) in the number of patients who reported a return of symptoms between the covered (5/17 or 29.4%) and uncovered (18/30 or 60%) groups. There was also a significant difference (p = < 0.001) in the mean percent stenosis after stent placement between the covered [17.9% (range 0-100) ± 26.2] and uncovered [48.3% (range 6.8-100) ± 33.5] groups. No significant difference (p = 0.227) was found in the time (days) between the date of the procedure and the date of clinical follow-up where a return of symptoms was reported [covered: 426.6 (range 28-1554) ± 633.9 and uncovered 778.1 (range 23-3851) ± 1066.8]. One patient in the uncovered group had non-endovascular surgical intervention (innominate to right atrial bypass), while none in the covered group required surgical intervention. One major complication (SIR grade C) occurred that consisted of a pericardial hemorrhagic effusion after angioplasty that required covered stent placement. There were no procedure-related deaths. Both covered and

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.

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.

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.

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.

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.

Covered Stent Grafts for Acquired Arterial Venous Fistulas: A Case Series.

PubMed

Sarac, Timur P; Vargas, Lina; Kashyap, Vikram; Cardella, Jonathan; Chaar, Cassius Ochoa

2018-01-01

Stent grafts have become the preferred method for treating abdominal aortic aneurysms (AAAs) but also have utility in treating other vasculopathies. In 2005, peripheral stent grafts were approved for treating superficial femoral artery occlusive disease. This report describes our experience using covered stent grafts to treat acquired arterial venous fistulae (aAVF). We reviewed the records of patients treated for aAVF with covered stent grafts. Eleven patients had 12 limbs treated with a stent graft. The data collected included presenting symptoms, mechanism of injury, vessel location, stent graft used for therapy, and patency. Eleven patients underwent successful treatment of 12 aAVF with a peripheral stent grafts. The average age was 55.6 (18-87), and there were 4 women and 7 men. The mechanisms of injuries were heart catheterization in 5 patients, penetrating trauma in 3 patients, and orthopedic injury in 3 patients. Five of the patients had concurrent pseudoaneurysms. Self-expanding expanded polytetrafluoroethelene (ePTFE) stent grafts were used in 8 patients, and balloon-expandable ePTFE stent grafts were used in 3 patients. Primary patency at 2 years is 100%, with all patients having significant relief of symptoms. Peripheral stent grafts are a useful tool for treating aAVF, with excellent patency. They provide a valuable minimally invasive approach to this disease. Copyright © 2017 Elsevier Inc. All rights reserved.

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

[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.

Transjugular Intrahepatic Portosystemic Shunt Flow Reduction with Adjustable Polytetrafluoroethylene-Covered Balloon-Expandable Stents Using the “Sheath Control” Technique

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

Blue, Robert C., E-mail: Robert.c.blue@gmail.com; Lo, Grace C.; Kim, Edward

PurposeA complication of transjugular intrahepatic portosystemic shunts (TIPS) placement is refractory portosystemic encephalopathy (PSE) often requiring TIPS reduction. We report the results of a “sheath control technique” utilizing constraining sheaths during deployment of polytetrafluoroethylene (PTFE)-covered balloon-expandable stents, minimizing stent migration, and providing additional procedural control.MethodsTIPS reduction was performed in 10 consecutive patients for PSE using Atrium iCast covered stents (Atrium Maquet Getinge Group, Germany). Within the indwelling TIPS stent, a 9 mm × 59 mm iCast stent was deployed with 2 cm exposed from the sheath’s distal end and the majority of the stent within the sheath to create the distal hourglass shape. During balloonmore » retraction, the stent was buttressed by the sheath. The proximal portion of the stent was angioplastied to complete the hourglass configuration, and the central portion of the stent was dilated to 5 mm. Demographics, pre- and post-procedure laboratory values, and outcomes were recorded.ResultsTen patients underwent TIPS reduction with 100 % technical success. There was no stent migration during stent deployment. All patients experienced initial improvement of encephalopathy. One patient ultimately required complete TIPS occlusion for refractory PSE, and another developed TIPS occlusion 36 days post-procedure. There was no significant trend toward change in patients’ MELD scores immediately post-procedure or at 30 days (p = 0.46, p = 0.47, respectively).ConclusionTIPS reduction using Atrium iCast PTFE balloon-expandable stents using the “sheath control technique” is safe and effective, and minimizes the risk of stent migration.« 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

Use of covered self-expandable stents for benign colorectal disorders in children.

PubMed

Lange, Bettina; Sold, Moritz; Kähler, Georg; Wessel, Lucas M; Kubiak, Rainer

2017-01-01

There is a lack of experience with covered self-expandable stents for benign colorectal disorders in children. Five children (4M, 1F) with a median age of 5years (range, 6months-9years) who underwent treatment with covered self-expandable plastic (SEPSs) or self-expandable metal stents (SEMSs) for a benign colorectal condition between April 2005 and November 2013 were recruited to this retrospective study. Etiologies included: anastomotic stricture with (n=1) or without (n=3) simultaneous enterocutaneous fistula, as well as an anastomotic leak associated with enterocutaneous fistula (n=1). All children suffered from either Hirschsprung's disease (n=3) or total colonic aganglionosis (Zuelzer-Wilson syndrome) (n=2). Median duration of individual stent placement was 23days (range, 1-87days). In all cases up to five different stents were placed over time. At follow-up two patients were successfully treated without further intervention. In another patient the anastomotic stricture resolved fully, but a coexisting enterocutaneous fistula persisted. Overall, three patients did not improve completely following stenting and required definite surgery. Stent-related problems were noted in all cases. There was one perforation of the colon at stent insertion. Further complications consisted of stent dislocation (n=4), obstruction (n=1), formation of granulation tissue (n=1), ulceration (n=1) and discomfort (n=3). Covered self-expandable stents enrich the armamentarium of interventions for benign colorectal disorders in children including anastomotic strictures and intestinal leaks. A stent can be applied either as an emergency procedure (bridge to surgery) or as an adjuvant treatment further to endoscopy and dilatation. Postinterventional problems are frequent but there is a potential for temporary or definite improvement following stent insertion. Copyright © 2017. Published by Elsevier Inc.

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

Tracheal stricture and fistula: management with a barbed silicone-covered retrievable expandable nitinol stent.

PubMed

Kim, Yong Hee; Shin, Ji Hoon; Song, Ho-Young; Kim, Jin Hyoung

2010-02-01

The purpose of this study was to evaluate the safety and effectiveness of a barbed silicone-covered retrievable expandable nitinol stent in preventing stent migration in patients with tracheal strictures or fistulas. Under fluoroscopic guidance, barbed silicone-covered retrievable expandable nitinol stents were placed in 15 patients with tracheal strictures, two patients with fistulas, two patients with combined strictures and fistulas, and one patient with variable extrathoracic airway obstruction. The three pairs of barbs were attached to the external stent surface at the middle of the stent at equal intervals. Technical success, improvement in respiratory status, complications, and related interventions were evaluated. The technical success rate was 100%, and respiratory status improved or the fistula closed in all 20 patients. Complications included sputum retention (three patients), tumor overgrowth (three patients), pain (one patient), and granulation tissue formation (one patient). No stent migration occurred, even in the three patients without fixed strictures. Four stents subsequently were removed because of complications, and one stent was removed because the patient's condition improved. Stent removal was not difficult and was uneventful. The silicone membranes and barbs of the removed stents were intact. Use of a barbed silicone-covered retrievable expandable nitinol stent relieves dyspnea and facilitates fistula closure in patients with benign or malignant tracheal strictures or fistulas. The barbed design of the stent is important in preventing migration.

Comparison of covered and uncovered self-expandable stents in the treatment of malignant biliary obstruction.

PubMed

Flores Carmona, Diana Yamel; Alonso Lárraga, Juan Octavio; Hernández Guerrero, Angélica; Ramírez Solís, Mauro Eduardo

2016-05-01

Drainage with metallic stents is the treatment of choice in malignant obstructive jaundice. Technical and clinical success with metallic stents is obtained in over 90% and 80% of cases, respectively. There are self-expandable metallic stents designed to increase permeability. The aim of this study was to describe the results obtained with totally covered self-expandable and uncovered self-expandable metallic stents in the palliative treatment of malignant biliary obstruction. Sixty eight patients with malignant obstructive jaundice secondary to pancreatobiliary or metastatic disease not amenable to surgery were retrospectively included. Two groups were created: group A (covered self-expandable metallic stents) (n = 22) and group B (uncovered self-expandable metallic stents) (n = 46). Serum total bilirubin, direct bilirubin, alkaline phosphatase and gamma glutamyl transferase levels decreased in both groups and no statistically significant difference was detected (p = 0.800, p = 0.190, p = 0.743, p = 0.521). Migration was greater with covered stents but it was not statistically significant either (p = 0.101). Obstruction was greater in the group with uncovered stents but it was not statistically significant either (p = 0.476). There are no differences when using covered self-expandable stents or uncovered self-expandable stents in terms of technical and clinical success or complications in the palliative treatment of malignant obstructive jaundice.

Outcomes of Temporary Partially Covered Stent Placement for Benign Tracheobronchial Stenosis.

PubMed

Ma, Ji; Han, Xinwei; Wu, Gang; Jiao, Dechao; Ren, Kewei; Bi, Yonghua

2016-08-01

To evaluate the intermediate outcomes of temporary partially covered tracheobronchial stenting in patients with benign tracheobronchial stenosis. We conducted a retrospective study of patients with benign tracheobronchial stenosis who underwent stent placement. All stents were removed approximately 3 months after placement. Respiratory function was assessed using the visual analogue scale (VAS) and Karnofsky performance status scale (KPS) before and after stent placement. The lumen diameters of the stenotic lesions were measured using chest computed tomography (CT) and compared between before stent placement and after stent removal. A total of 51 stents were successfully placed in consecutive 51 patients with benign tracheobronchial stenosis. No serious complications occurred. The mean VAS and KPS scores significantly improved after stent removal (6.291 ± 0.495 and 25.352 ± 10.533, respectively) compared with those before stent placement (1.493 ± 0.504 and 60.140 ± 16.344, respectively; P < 0.05). The mean lumen transverse diameters of the stenotic site in trachea and main bronchus after stent removal (17.235 ± 3.457 and 8.993 ± 0.961 mm; 1 month post-removal; 16.353 ± 4.132 and 8.357 ± 1.082 mm; 6 months post-removal) were significantly larger than those before stent placement (7.876 ± 2.351 and 2.143 ± 0.770 mm, respectively; P < 0.05). However, the mean lumen diameters between 1 and 6 months after stent removal had no significant difference (P > 0.05). Temporary partially covered stenting may be a safe and effective treatment for benign tracheobronchial stenosis.

A new intratracheal stent made from nitinol, an alloy with "shape memory effect".

PubMed

Vinograd, I; Klin, B; Brosh, T; Weinberg, M; Flomenblit, Y; Nevo, Z

1994-05-01

Temporary or permanent tracheal splinting in pediatric patients may be indicated in tracheomalacia or bronchomalacia, repair of congenital tracheal stenosis, and after tracheal resection. This study presents the results of the development of a new intraluminal airway stent made from titanium alloy, a metal with "shape memory effect". At low temperatures (martensitic state) the titanium alloy stent can be fashioned into a specific shape; then when heated to a higher temperature (austenitic state) the stent alters its shape, only to regain its original shape when recooled to the lower temperature. The stent, connected to a small electric power supply, was introduced into 20 young rabbits with the use of a 2.5 cm rigid bronchoscope. After implantation in the martensitic state the stent was warmed to 40 degrees C, the austenitic state, by an electric current of 1.5 to 3 ampere for 1 to 2 seconds. After a period of 8 to 10 weeks the stent was removed (in its martensitic state) through the same-sized bronchoscope after being cooled with 3 to 4 ml of 80% alcohol solution at 6 degrees C. No signs of airway obstruction developed in any of the animals after implantation or extraction of the stent. The biomechanical properties of the trachea, as shown by strain measurements with the use of incremental forces, showed significant differences between the stented and unstented segments (p < 0.005). The titanium alloy intratracheal stent adequately fulfilled the requirements of a temporary intraluminal airway splint, and because of its unique feature of shape memory effect the stent could be inserted, fixed, and removed easily, even in very small airways.

Elective implantation of covered stents for coarctation and recoarctation in adolescents and adults.

PubMed

Alcibar, Juan; Blanco, Roberto; Fernandez, Luis; Arriola, Josune; Garcia, Koldobika; Peña, Natividad; Inguanzo, Ramón; Voces, Roberto; Castellanos, Enrique; Montes, Pedro M

2013-06-01

Stent implantation is an effective therapy for aortic coarctation and recoarctation. However, in adolescents and adults, aortic wall rupture and dissection can occur, as well as aneurysms during follow-up. In order to reduce these complications, we electively implant covered stents. Since 2005, we have performed the procedure using femoral access in 17 patients (2 adolescents and 15 adults), 16 electively and 1 as a rescue procedure. We used the Mullins technique in all cases, implanting a NuMED(®) covered stent. Good stent apposition was achieved in all 17 procedures; 8 patients required a distal flare. Gradient was reduced from 40 (16) mmHg to 2 (2) mmHg (P<.001) and lumen diameter increased from 4 (2) mm to 19 (3) mm (P<.001). Two exceptional cases are discussed: one patient with aortic wall rupture who underwent a rescue procedure using a stent within a covered stent and another patient with total obstruction and intercostal aneurysm in whom the outcome was fatal at 48 h postprocedure (autopsy is shown). Four-year clinical follow-up included Doppler echocardiography; an additional imaging technique was required in 13 patients. All patients recovered well and there were no complications. Covered stents are effective in treating coarctation and recoarctation in adolescents and adults, are the treatment of choice in patients with complex anatomy, and must be available in the operating room as a rescue device when implanting a conventional stent. Copyright © 2012 Sociedad Española de Cardiología. Published by Elsevier Espana. 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.

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.

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.

Covered Biodegradable Stent: New Therapeutic Option for the Management of Esophageal Perforation or Anastomotic Leak

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

Cerna, Marie; Koecher, Martin, E-mail: martin.kocher@seznam.cz; Valek, Vlastimil

2011-12-15

Purpose: This study was designed to evaluate our experience with the treatment of postoperative anastomotic leaks and benign esophageal perforations with covered biodegradable stents. Materials and Methods: From 2008 to 2010, we treated five men with either an anastomotic leak or benign esophageal perforation by implanting of covered biodegradable Ella-BD stents. The average age of the patients was 60 (range, 38-74) years. Postoperative anastomotic leaks were treated in four patients (1 after esophagectomy, 1 after resection of diverticulum, 2 after gastrectomy). In one patient, perforation occurred as a complication of the treatment of an esophageal rupture (which occurred during amore » balloon dilatation of benign stenosis) with a metallic stent. Results: Seven covered biodegradable stents were implanted in five patients. Primary technical success was 100%. Clinical success (leak sealing) was achieved in four of the five patients (80%). Stent migration occurred in three patients. In two of these patients, the leak had been sealed by the time of stent migration, therefore no reintervention was necessary. In one patient an additional stent had to be implanted. Conclusion: The use of biodegradable covered stents for the treatment of anastomotic leaks or esophageal perforations is technically feasible and safe. The initial results are promising; however, larger number of patients will be required to evaluate the capability of these biodegradable stents in the future. The use of biodegradable material for coverage of the stent is essential.« less

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.

Covered biliary stents with proximal bare stent extension for the palliation of malignant biliary disease: can we reduce tumour overgrowth rate?

PubMed

Krokidis, Miltiadis; Hatzidakis, Adam

2017-08-01

Covered biliary stents have shown significant effectiveness in the palliative management of patients with malignant biliary disease due to prevention of tumour ingrowth. However, stent dysfunction may still occur due to growth of tumour at the borders of the covered stent (tumour overgrowth). The aim of this study is to assess the effectiveness of a bare extension in the prevention of tumour overgrowth when covered stents are used in the palliative treatment of malignant biliary strictures. This is a prospective, single arm, cohort study. Twenty-two patients with inoperable malignant biliary strictures in the distal common bile duct (Bismuth I-II) and life expectancy more than 6 months were included in the study. The combination of a fully covered biliary stent and a bare proximal and distal extension was used in all cases. All patients were followed-up until death. Primary patency, survival, complication rates and dysfunction cause were assessed. Mean survival was 263.7 days (median 255, SD: 77.6). Mean patency was 240 days (median: 237, SD: 87). The primary patency rate at 3, 6 and 12 months was 90%, 86% and 86% respectively. Tumour inor overgrowth did not occur in any of the patients. Dysfunction due to sludge formation occurred in three cases; all three were treated with bilioplasty. The combined use of a covered biliary stent and a bare extension appears to be a very effective tool in the palliation of malignant biliary disease, offering long-term patency for patients with inoperable malignant distal common bile duct strictures and increasing the quality of life of such patients.

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.

Treatment of Malignant Biliary Obstruction with a PTFE-Covered Self-Expandable Nitinol Stent

PubMed Central

Kwak, Hyo-Sung; Jin, Gong-Yong; Lee, Seung-Ok; Chung, Gyung-Ho

2007-01-01

Objective We wanted to determine the technical and clinical efficacy of using a PTFE-covered self-expandable nitinol stent for the palliative treatment of malignant biliary obstruction. Materials and Methods Thirty-seven patients with common bile duct strictures caused by malignant disease were treated by placing a total of 37 nitinol PTFE stents. These stents were covered with PTFE with the exception of the last 5 mm at each end; the stent had an unconstrained diameter of 10 mm and a total length of 50-80 mm. The patient survival rate and stent patency rate were calculated by performing Kaplan-Meier survival analysis. The bilirubin, serum amylase and lipase levels before and after stent placement were measured and then compared using a Wilcoxon signed-rank test. The average follow-up duration was 27.9 weeks (range: 2-81 weeks). Results Placement was successful in all cases. Seventy-six percent of the patients (28/37) experienced adequate palliative drainage for the remainder of their lives. There were no immediate complications. Three patients demonstrated stent sludge occlusion that required PTBD (percutaneous transhepatic biliary drainage) irrigation. Two patients experienced delayed stent migration with stone formation at 7 and 27 weeks of follow-up, respectively. Stent insertion resulted in acute elevations of the amylase and lipase levels one day after stent insertion in 11 patients in spite of performing endoscopic sphincterotomy (4/6). The bilirubin levels were significantly reduced one week after stent insertion (p < 0.01). The 30-day mortality rate was 8% (3/37), and the survival rates were 49% and 27% at 20 and 50 weeks, respectively. The primary stent patency rates were 85%, and 78% at 20 and 50 weeks, respectively. Conclusion The PTFE-covered self-expandable nitinol stent is safe to use with acceptable complication rates. This study is similar to the previous studies with regard to comparing the patency rates and survival rates. PMID:17923784

[Experimental study of an intratracheal stent made of shape memory alloy].

PubMed

Yoshimura, M; Tsugawa, C; Tsubota, N

1994-11-01

To develop a new prosthesis for treating tracheal stenosis and tracheobronchomalacia, we examined the usefulness of an intratracheal stent made of shape memory alloy (SMA), a titanium-nickel alloy composed of 50% of each metal. At its recovery temperature (37 degrees C), the SMA stent was designed to recall the memorized shape of a coil with a diameter of 5 or 6 mm and a length of 10 mm. For the present experiment, it was transformed to a smaller coil 3 mm in diameter at a low temperature (-50 degrees C) and then loaded into the prosthesis introducer tube. An experimental model of potentially fatal tracheomalacia was made surgically by cutting and fracturing the tracheal cartilages of rabbits and tracheal collapse was confirmed by rigid bronchoscope. The introducer tube with the SMA stent was inserted and then the prosthesis was advanced into the collapsed segment of the trachea using the stent pusher. The SMA stent warmed bo body temperature and recovered its memorized shape after 1-2 min. In 3 out of 8 rabbits, follow-up bronchoscopy performed at 6, 8, and 10 months after implantation revealed satisfactory patency of the SMA stent and the trachea. After follow-up, 3 animals were sacrificed for histological observation, which showed little proliferation of granulation tissue and no dislocation of the SMA stent from the malacic portion. The remaining 5 rabbits have been followed for 18-24 months and are doing well. We conclude that the SMA stent maintains good tracheal patency, causes little reaction in the tracheal wall, and is easy to handle. Thus, it shows the potential for clinical application.

Covered Stent and Coils Embolization of a Pulmonary Artery Pseudoaneurysm After Gunshot Wound

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

Huet, Nicolas, E-mail: nhuet@chu-grenoble.fr; Rodiere, Mathieu, E-mail: mrodiere@chu-grenoble.fr; Badet, Michel, E-mail: michel.badet@ch-chambery.fr

We report the first case of endovascular covered stent implantation for the treatment of a large pulmonary artery pseudoaneurysm (PAPA) following a right thoracic gunshot wound. After resuscitation and hemodynamic stabilization, a CT angiography was performed to analyze the neck size of the PAPA and its position relative to the branches of the parent artery. Covered stent implantation with additional coil embolization was successfully performed. At the 4-year follow-up, the stents remained patent and there was neither pseudoaneurysm recurrence nor treatment-related complication.

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.

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.

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).

Bronchoscopic management of critical central airway obstruction by thyroid cancer: Combination airway stenting using tracheal and inverted-Y carinal self-expanding metallic stents

PubMed Central

Madan, Karan; Shrestha, Prajowl; Garg, Rakesh; Hadda, Vijay; Mohan, Anant; Guleria, Randeep

2017-01-01

Central airway obstruction (CAO) can result from various benign and malignant etiologies. Anaplastic thyroid cancer (ATC) is the most aggressive form of thyroid cancer. Rapid airway compromise is the main cause of death in ATC. We report a patient with ATC who presented with a large neck mass leading to CAO with long segment tracheal and right main bronchial compression and respiratory failure. Urgent Rigid Bronchoscopy was performed for airway stabilization and patient was managed with a combination airway stenting approach. A combination of self expanding, metallic, covered inverted Y and straight tracheal stents was used to stabilize the near complete airway structure. We herein highlight the role of therapeutic rigid bronchoscopy with airway stenting as an efficacious treatment modality for management of malignant CAO. PMID:28360477

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.

Use of covered stents in simultaneous management of coarctation of the aorta and patent ductus arteriosus.

PubMed

Hekim Yılmaz, Emine; Bulut, Mustafa Orhan; Küçük, Mehmet; Yücel, İlker Kemal; Erdem, Abdullah; Çelebi, Ahmet

2018-03-21

To report clinical and procedural characteristics of twelve patients who received a covered stent for the treatment of aortic coarctation and concurrent patent ductus arteriosus (PDA). A single center database was retrospectively evaluated to obtain data of patients with combined aortic coarctation and PDA. We selected patients in whom a covered stent was used for the treatment of both pathologies. The stent length was chosen so as to cover the entire length of the lesion from healthy to healthy tissue and also cover the ampulla of PDA. The median age of the patients was 15 (range, 6.5-35) years. The diameter of the coarctated segment increased from a median of 8.4 (range, 2.6-10.8) mm to 16 (range, 9-24) mm (p<0.005), whereas the pressure gradient decreased from a median of 43 (range, 10-71) mm Hg to 0 (range, 0-8) mm Hg (p<0.005). Fourteen covered stents were used for 12 patients. Following deployment, seven stents were flared with larger and low-pressure balloons because of the gap between the distal end of the stent and the poststenotic dilated segment of the aorta, which caused residual PDA shunts and/or instability of the stent. After the procedure, no residual PDA shunt was present in any patient. To the best of our knowledge, this study includes the largest series of patients reported in literature in whom covered CP stents were used for simultaneous percutaneous treatment of coarctation and PDA. The procedure was successful and stable results were obtained during follow-up in all cases.

Biodegradable membrane-covered stent from chitosan-based polymers.

PubMed

Thierry, Benjamin; Merhi, Yahye; Silver, Jim; Tabrizian, Maryam

2005-12-01

Membrane-covered devices could help treat disease of the vasculature such as aneurysm, rupture, and fistulas. They are also investigated to reduce embolic complication associated with revascularization of saphenous vein graft. The aim of this study is to design a clinically applicable biodegradable membrane-covered stent based on the natural polysaccharide chitosan, which has been developed. The mechanical properties of the membrane is optimized through blending with polyethylene oxide (70:30% Wt CH:PEO). The membrane was able to sustain the mechanical deformation of the supporting self-expandable metallic stents during its deployment. The membrane was demonstrated to resist physiological transmural pressure (burst pressure resistance >500 mm Hg) and presented a high-water permeation resistance (1 mL/cm(2) min(-1) at 120 mmHg). The CH-PEO membrane showed a good hemocompatibility in an ex vivo assay. Heparin and hyaluronan surface complexation with the membrane further reduced platelet adhesion by 50.1 and 63% (p = 0.05). The ability of the membrane-covered devices to be used as a drug reservoir was investigated using the nitric oxide donor sodium nitroprusside (SNP). SNP-loaded membranes displayed significantly reduced platelet adhesion. (c) 2005 Wiley Periodicals, Inc.

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 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.

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.

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.

Magnesium alloy covered stent for treatment of a lateral aneurysm model in rabbit common carotid artery: An in vivo study

NASA Astrophysics Data System (ADS)

Wang, Wu; Wang, Yong-Li; Chen, Mo; Chen, Liang; Zhang, Jian; Li, Yong-Dong; Li, Ming-Hua; Yuan, Guang-Yin

2016-11-01

Magnesium alloy covered stents have rarely been used in the common carotid artery (CCA). We evaluated the long-term efficacy of magnesium alloy covered stents in a lateral aneurysm model in rabbit CCA. Magnesium alloy covered stents (group A, n = 7) or Willis covered stents (group B, n = 5) were inserted in 12 New Zealand White rabbits and they were followed up for 12 months. The long-term feasibility for aneurysm occlusion was studied through angiograms; the changes in vessel area and lumen area were assessed with IVUS. Complete aneurysmal occlusion was achieved in all aneurysms. Angiography showed that the diameter of the stented CCA in group A at 6 and 12 months was significantly greater than the diameter immediately after stent placement. On intravascular ultrasound (IVUS) examination, the mean lumen area of the stented CCA in group A was significantly greater at 6 and 12 months than that immediately after stent placement; the mean lumen area was also significantly greater in group A than in group B at the same time points. The magnesium alloy covered stents proved to be an effective approach for occlusion of lateral aneurysm in the rabbit CCA; it provides distinct advantages that are comparable to that obtained with the Willis covered stent.

Wing-shaped plastic stents vs. self-expandable metal stents for palliative drainage of malignant distal biliary obstruction: a randomized multicenter study.

PubMed

Schmidt, Arthur; Riecken, Bettina; Rische, Susanne; Klinger, Christoph; Jakobs, Ralf; Bechtler, Matthias; Kähler, Georg; Dormann, Arno; Caca, Karel

2015-05-01

Previous studies have shown superior patency rates for self-expandable metal stents (SEMS) compared with plastic stents in patients with malignant biliary obstruction. The aim of this study was to compare stent patency, patient survival, and complication rates between a newly designed, wing-shaped, plastic stent and SEMSs in patients with unresectable, malignant, distal, biliary obstruction. A randomized, multicenter trial was conducted at four tertiary care centers in Germany. A total of 37 patients underwent randomization between March 2010 and January 2013. Patients underwent endoscopic retrograde cholangiography with insertion of either a wing-shaped, plastic stent without lumen or an SEMS.  Stent failure occurred in 10/16 patients (62.5 %) in the winged-stent group vs. 4/18 patients (22.2 %) in the SEMS group (P = 0.034). The median time to stent failure was 51 days (range 2 - 92 days) for the winged stent and 80 days (range 28 - 266 days) for the SEMS (P = 0.002). Early stent failure (< 8 weeks after placement) occurred in 8 patients (50 %) vs. 2 patients (11.1 %), respectively (P = 0.022). After obtaining the results from this interim analysis, the study was discontinued because of safety concerns. The frequency of stent failure was significantly higher in the winged-stent group compared with the SEMS group. A high incidence of early stent failure within 8 weeks was observed in the winged-stent group. Thus, the winged, plastic stent without central lumen may not be appropriate for mid or long term drainage of malignant biliary obstruction. Study registration ClinicalTrials.gov (NCT01063634). © Georg Thieme Verlag KG Stuttgart · New York.

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

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.

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.

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.

Self-expanding Y stents in the treatment of central airway stenosis: a retrospective analysis.

PubMed

Gompelmann, Daniela; Eberhardt, Ralf; Schuhmann, Maren; Heussel, Claus P; Herth, Felix J F

2013-10-01

Central airway obstruction (CAO) is a life-threatening situation. Stent insertion re-establishes patency of the central airways. Self-expanding metallic Y stents have been available since 2005, widening the spectrum of interventional bronchoscopic techniques. Retrospective analysis of all patients treated for CAO with a self-expanding metallic Y stent at the Thoraxklinik Heidelberg between May 2005 and January 2009. A total of 43 patients aged 26-81 had a metallic Y stent inserted endoscopically for the treatment of CAO; 39 of these patients (90.7%) had CAO due to malignant disease, four patients (9.3%) due to benign disease. In all 43 patients, the Y stent was deployed without any complications. A longitudinal follow up was possible in 32 of the 43 patients. The stents remained in situ for an average of 107.1 days (range 1-640 days). In 29 patients with malignant CAO the stenosis was successfully overcome with a Y stent; 11 of these patients died within 6 weeks following stent insertion. On follow up the remaining 18 patients showed immediate improvement of dyspnoea. Eight out of the 18 patients (44.4%) tolerated the stent without problems, two (11.1%) required further stenting, six (33.3%) had complications such as increased secretions, cough, dyspnoea or granulation tissue formation. The stent was removed in one patient (5.6%) due to increased secretions, and in another (5.6%) as the stent was no longer required due to successful tumour-specific therapy. Placement of Y stents in symptomatic CAO allows for quick relief of symptoms. Severe complications are rare. Stent removal is possible after successful treatment of the primary tumour. However, the prognostic indicator for survival is the underlying malignancy.

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.

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

A Novel Partially Covered Self-Expandable Metallic Stent with Proximal Flare in Patients with Malignant Gastric Outlet Obstruction.

PubMed

Takahara, Naminatsu; Isayama, Hiroyuki; Nakai, Yousuke; Yoshida, Shuntaro; Saito, Tomotaka; Mizuno, Suguru; Yagioka, Hiroshi; Kogure, Hirofumi; Togawa, Osamu; Matsubara, Saburo; Ito, Yukiko; Yamamoto, Natsuyo; Tada, Minoru; Koike, Kazuhiko

2017-07-15

Endoscopic placement of self-expandable metal stents (SEMSs) has emerged as a palliative treatment for malignant gastric outlet obstruction (GOO). Although covered SEMSs can prevent tumor ingrowth, frequent migration of covered SEMSs may offset their advantages in preventing tumor ingrowth. We conducted this multicenter, single-arm, retrospective study at six tertiary referral centers to evaluate the safety and efficacy of a partially covered SEMS with an uncovered large-bore flare at the proximal end as an antimigration system in 41 patients with symptomatic malignant GOO. The primary outcome was clinical success, and the secondary outcomes were technical success, stent dysfunction, adverse events, and survival after stent placement. The technical and clinical success rates were 100% and 95%, respectively. Stent dysfunctions occurred in 17 patients (41%), including stent migration in nine (23%), tumor ingrowth in one (2%), and tumor overgrowth in four (10%). Two patients (5%) developed adverse events: one pancreatitis and one perforation. No procedure-related death was observed. A novel partially covered SEMS with a large-bore flare proximal end was safe and effective for malignant GOO but failed to prevent stent migration. Further research is warranted to develop a covered SEMS with an optimal antimigration system.

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.

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

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

Full covered self-expandable metal stents for the treatment of anastomotic leak using a silk thread

PubMed Central

Choi, Cheol Woong; Kang, Dae Hwan; Kim, Hyung Wook; Park, Su Bum; Kim, Su Jin; Hwang, Sun Hwi; Lee, Si Hak

2017-01-01

Abstract To evaluate the safety and effectiveness of fixation of the fully covered self-expandable metal stent (SEMS) placement using a silk thread for complete closure of an anastomotic leak. An anastomotic leak is a life-threatening complication after gastrectomy. Although the traditional treatment of choice was surgical re-intervention, an endoscopic SEMS can be used alternatively. During the study period, we retrospectively reviewed consecutive patients who received a modified covered SEMS capable of being fixed using a silk thread (Shim technique) due to an anastomotic leak after gastrectomy to prevent stent migration. Demographic data, stent placement and removal, clinical success, time to resolution, and complications were evaluated. A total of 7 patients underwent fully covered SEMS with a silk thread placement for an anastomotic leak after gastrectomy to treat gastric cancer. The patients’ mean age was 71.3 ± 8.0 years. Man sex was predominant (85.7%). All patients’ American Society of Anesthesiologists (ASA) scores were between I and III. Total gastrectomy was performed in 5 patients (71.4%) and proximal gastrectomy was performed in 2 patients (28.6%). The time between gastrectomy and stent insertion was 22.3 ± 11.1 days. The size of the leaks was 27.1 ± 11.1 mm. Technical success and complete leak closure were achieved in all patients. Stent migration was absent. All stents were removed between 4 and 6 weeks. Delayed esophageal stricture was found in 1 patient (14.2) and successfully resolved after endoscopic balloon dilation. For an anastomotic leak after gastrectomy, fully covered SEMS placement with a silk thread is an effective and safe treatment option without stent migration. The stent extraction time between 4 and 6 weeks was optimal without severe complications. PMID:28723752

Full covered self-expandable metal stents for the treatment of anastomotic leak using a silk thread.

PubMed

Choi, Cheol Woong; Kang, Dae Hwan; Kim, Hyung Wook; Park, Su Bum; Kim, Su Jin; Hwang, Sun Hwi; Lee, Si Hak

2017-07-01

To evaluate the safety and effectiveness of fixation of the fully covered self-expandable metal stent (SEMS) placement using a silk thread for complete closure of an anastomotic leak. An anastomotic leak is a life-threatening complication after gastrectomy. Although the traditional treatment of choice was surgical re-intervention, an endoscopic SEMS can be used alternatively.During the study period, we retrospectively reviewed consecutive patients who received a modified covered SEMS capable of being fixed using a silk thread (Shim technique) due to an anastomotic leak after gastrectomy to prevent stent migration. Demographic data, stent placement and removal, clinical success, time to resolution, and complications were evaluated.A total of 7 patients underwent fully covered SEMS with a silk thread placement for an anastomotic leak after gastrectomy to treat gastric cancer. The patients' mean age was 71.3 ± 8.0 years. Man sex was predominant (85.7%). All patients' American Society of Anesthesiologists (ASA) scores were between I and III. Total gastrectomy was performed in 5 patients (71.4%) and proximal gastrectomy was performed in 2 patients (28.6%). The time between gastrectomy and stent insertion was 22.3 ± 11.1 days. The size of the leaks was 27.1 ± 11.1 mm. Technical success and complete leak closure were achieved in all patients. Stent migration was absent. All stents were removed between 4 and 6 weeks. Delayed esophageal stricture was found in 1 patient (14.2) and successfully resolved after endoscopic balloon dilation.For an anastomotic leak after gastrectomy, fully covered SEMS placement with a silk thread is an effective and safe treatment option without stent migration. The stent extraction time between 4 and 6 weeks was optimal without severe complications.

Bronchobiliary Fistula Treated by Self-expanding ePTFE-Covered Nitinol Stent-Graft

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

Gandini, Roberto; Konda, Daniel; Tisone, Giuseppe

A 71-year-old man, who had undergone right hepatectomy extended to the caudate lobe with terminolateral Roux-en-Y left hepatojejunostomy for a Klatskin tumor, developed bilioptysis 3 weeks postoperatively due to bronchobiliary fistula. Percutaneous transhepatic cholangiography revealed a non-dilated biliary system with contrast medium extravasation to the right subphrenic space through a resected anomalous right posterior segmental duct. After initial unsuccessful internal-external biliary drainage, the fistula was sealed with a VIATORR covered self-expanding nitinol stent-graft placed with its distal uncovered region in the hepatojejunal anastomosis and the proximal ePTFE-lined region in the left hepatic duct. A 10-month follow-up revealed no recurrence ofmore » bilioptysis and confirmed the complete exclusion of the bronchobiliary fistula.« less

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.

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.

Evaluation of the Biodurability of Polyurethane-Covered Stent Using a Flow Phantom

PubMed Central

Kim, Dong Hyun; Choi, Jung Ryul; Byun, Ju Nam; Kim, Young Chul; Ahn, Young Moo

2001-01-01

Objective To evaluate the biodurability of the covering material in retrievable metallic stents covered with polycarbonate polyurethane. Materials and Methods Using a peristaltic pump at a constant rate of 1ml/min, bile was recirculated from a reservoir through a long tube containing four stents. Each of these was removed from the system every two weeks and a radial tensile strength test and scanning electron microscopy (SEM) were performed. Each stent, removed at 2, 4, 6 and 8 weeks, was compared with a control stent not exposed to bile juice. Results Gross examination showed that stents were intact at 2 weeks, but at 4, 6 and 8 weeks cracks were observed. The size of these increased gradually in accordance with the duration of exposure, and at 8 weeks several large holes in the polyurethane membrane were evident. With regard to radial tensile strength, extension and peak load at break were 84.47% and 10.030 N/mm, 54.90% and 6.769 N/mm, 16.55% and 2.452 N/mm, 11.21% and 1.373 N/mm at 0, 2, 4 and 6 weeks, respectively. Scanning electron microscopy at 2 weeks revealed intermittent pitting and cracking, and examination at 4, 6 and 8 weeks showed that the size of these defects was gradually increasing. Conclusion When the polyurethane membrane was exposed to bile, biodegradation was first observed at week two and increased gradually according to the duration of exposure. PMID:11752974

[Membrane-covered self-expanding stents in the treatment of high-positioned esophageal stenosis or fistula].

PubMed

Liu, Jing-zheng; Zhong, Yun-shi; Xu, Mei-dong; Chen, Wei-feng; Zhou, Ping-hong; Yao, Li-qing

2013-12-01

To investigate the efficacy and safety of membrane-covered self-expanding metal stent in the treatment of high-positioned esophageal diseases, including esophageal stenosis, esophagotracheal fistula and anastomotic stricture. Clinical data of 84 patients who underwent stenting in our center from May 2005 to July 2013 were retrospectively analyzed. Of 84 patients, 31 were diagnosed as esophageal malignant stenosis, 2 compression stenosis, 10 radiation stenosis, 4 recurrent malignant stenosis, 27 anastomotic stricture, 1 esophageal stenosis after endoscopic submucosal dissection (ESD), 7 esophageal-tracheal fistula, 1 esophageal-mediastinal fistula, and 1 remnant stomach fistula. Distance from stenosis or fistula to central incisor was 15-20 cm in 48 cases, and more than 20 cm in 36 cases. All the patients were treated by 16 mm membrane-covered self-expanding metal stents. Main clinical manifestations and complications were evaluated. A total of 100 stents were placed in 84 patients,with a success rate of 100%. There were no complications such as perforation and bleeding during operation. Dysphagia and cough were improved quickly with a success rate of 100%. After the placement of stents, the incidence of complication was 6.0% (5/84), of which 2 cases were severe retrosternal pain, 1 was tracheal collapse, and 2 were stent displacement. Seventy-six patients (90.5%) received complete follow-up of 1 to 36 months (mean 15 months). Re-stenosis occurred in 4 cases, new esophageal-tracheal fistula in 2 cases. Among these 6 cases, 5 cases underwent successfully stent placement once again, and another one case received Savary bougie and Argon-ion coagulation with good efficacy. Endoscopic membrane-covered self-expanding metal stent placement is effective and safe for the relieve of dysphagia symptoms and the sealing of esophagotracheal fistula.

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.

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.

Outcomes after use of covered stents to treat coronary artery perforations. Comparison of old and new-generation covered stents.

PubMed

Hernández-Enríquez, Marco; Lairez, Olivier; Campelo-Parada, Francisco; Lhermusier, Thibault; Bouisset, Frédéric; Roncalli, Jérôme; Elbaz, Meyer; Carrié, Didier; Boudou, Nicolas

2018-05-28

To compare outcomes in patients receiving polytetrafluoroethylene (PTFE) and polyurethane (PL) covered stents (CS) after coronary artery perforation (CAP). The prognosis of CAP has improved with the advent of CSs. Information is scarce about the outcomes of new-generation CSs. Sixty-one patients were treated with CSs in a 5-years period (age = 77 ± 8.75% males). Procedural and clinical data were retrospectively collected. The primary endpoint was procedural success. Secondary endpoints included death and major adverse cardiac events (MACE) defined as a composite of death, myocardial infarction, target vessel, and lesion revascularization and need for surgical repair). Twenty-two (36%) received PL-CSs and 39 (65%) PTFE-CSs. There were no differences in procedural success (86% vs 69%, P = 0.216). Time to deliver was shorter with PL-CS despite larger length of stents (8[11] vs 15[16] min, P = 0.001; 20[5] vs 16[3] mm, P < 0.001). This group had lower rate of pericardial effusion and cardiac arrest (41% vs 72%, P = 0.028; 5% vs 26%, P = 0.045). At 1-year follow-up, MACE rates were similar (58% vs 56%, P = 1.000) with atrend toward TVR in the PL-CS arm (21% vs 5%, P = 0.083). No differences were found in mortality (26% vs 41%, P = 0.385). Each group had 1 stent thrombosis and in-stent restenosis trended higher in the PL-CS group (12% vs 3%, P = 0.223). Time to deliver was shorter with the PL-CS and resulted in lower rate of pericardial effusion and cardiac arrest. However, there were no significant differences in procedural success and 1-year follow-up MACE in patients treated with PL-CS or PTFE-CS. © 2018, Wiley Periodicals, Inc.

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

Covered Balloon-Expanding Stents in Airway Stenosis.

PubMed

Majid, Adnan; Kheir, Fayez; Chung, Jey; Alape, Daniel; Husta, Bryan; Oh, Scott; Folch, Erik

2017-04-01

The balloon-expanding stents are widely available but rarely described for use within the tracheobronchial tree. This report describes our experience with these stents in airway stenosis particularly as a lobar salvage therapy. This was a retrospective review of all records in which the balloon-expanding stents were used at a tertiary medical center. Ages, sex, location of stenosis, etiology of stenosis, stent size, duration of stent placement and associated interventions for airway stenosis were recorded. Patient's self-reported respiratory symptoms, dyspnea scale, and radiographic imaging at baseline and after stent placement were also reported. Twenty-one Atrium iCAST stents were inserted in 18 patients with malignant and benign airway disease. The median age was 69.5 years (interquartile range, 53.5 to 74). Most stents (n=20, 95%) were deployed in the lobar airways. There was a significant improvement in the modified Medical Research Council dyspnea scale from median of 3 to 2 (P<0.05). Self-reported respiratory symptoms improved in 14 patients (78%, P<0.05). Radiographic improvement post Atrium iCAST stent placement was achieved in 15 patients (83%). No deaths were related to airway stenting complications. Adverse events related to stents included migration (n=2, 9.5%), granulation tissue formation (n=2, 9.5%) and mucus plugging (n=1, 4.8%). Lobar stenting with balloon-expanding metallic stents appears feasible, safe and improves symptoms as well as radiographic atelectasis in patients with lobar airway stenosis in this small case series. Larger studies are needed to confirm this observation and to address long-term safety.

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.

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

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

Covered self-expandable metal stents with an anti-migration system improve patency duration without increased complications compared with uncovered stents for distal biliary obstruction caused by pancreatic carcinoma: a randomized multicenter trial.

PubMed

Kitano, Masayuki; Yamashita, Yukitaka; Tanaka, Kiyohito; Konishi, Hideyuki; Yazumi, Shujiro; Nakai, Yoshitaka; Nishiyama, Osamu; Uehara, Hiroyuki; Mitoro, Akira; Sanuki, Tsuyoshi; Takaoka, Makoto; Koshitani, Tatsuya; Arisaka, Yoshifumi; Shiba, Masatsugu; Hoki, Noriyuki; Sato, Hideki; Sasaki, Yuichi; Sato, Masako; Hasegawa, Kazunori; Kawabata, Hideaki; Okabe, Yoshihiro; Mukai, Hidekazu

2013-11-01

The requirements of biliary stents used in the palliation of malignant biliary obstruction are a long duration of patency and minimal adverse effects. Covered self-expandable metal stents (SEMSs) have been shown to prevent tumor ingrowth, which is the most frequent complication of uncovered SEMSs. However, because they are prone to migration, the superiority of covered SEMS has yet to be convincingly demonstrated. The aim of this study was to evaluate the superiority of covered over uncovered SEMSs in the palliation of distal biliary obstruction due to unresectable pancreatic carcinoma, using both stent types with relatively low axial force and uncovered flared ends to prevent their migration. From April 2009 to December 2010, 120 patients who were admitted to 22 tertiary-care centers because of distal biliary obstruction from unresectable pancreatic carcinomas were enrolled in this prospective randomized multicenter study. Patients were randomly assigned to receive a covered or uncovered SEMS deployed at the site of the biliary stricture during endoscopic retrograde cholangiopancreatography. Stent patency time, patient survival time, patient survival time without stent dysfunction (time to stent dysfunction or patient death), cause of stent dysfunction (ingrowth, overgrowth, migration, or sludge formation), and serious adverse events were compared between covered and uncovered SEMS groups. Patient survival time in the two groups did not significantly differ (median: 285 and 223 days, respectively; P=0.68). Patient survival time without stent dysfunction was significantly longer in the covered than in the uncovered SEMS group (median: 187 vs. 132 days; P=0.043). Stent patency was also significantly longer in the covered than in the uncovered SEMS group (mean±s.d.: 219.3±159.1 vs. 166.9±124.9 days; P=0.047). Reintervention for stent dysfunction was performed in 14 of 60 patients with covered SEMSs (23%) and in 22 of 60 patients with uncovered SEMSs (37%; P=0

Nitinol versus steel partially covered self-expandable metal stent for malignant distal biliary obstruction: a randomized trial.

PubMed

Soderlund, Claes; Linder, Stefan; Bergenzaun, Per E; Grape, Tomas; Hakansson, Hans-Olof; Kilander, Anders; Lindell, Gert; Ljungman, Martin; Ohlin, Bo; Nielsen, Jorgen; Rudberg, Claes; Stotzer, Per-Ove; Svartholm, Erik; Toth, Ervin; Frozanpor, Farshad

2014-11-01

Covered nitinol alloy self-expandable metal stents (SEMSs) have been developed to overcome the shortcomings of steel SEMS in patients with malignant biliary obstruction. In a randomized, multicenter trial, we compared stent patency, patient survival, and adverse events in patients with partly covered stents made from steel or nitinol. A total of 400 patients with unresectable distal malignant biliary obstruction were randomized at endoscopic retrograde cholangiopancreatography (ERCP) to insertion of a steel or nitinol partially covered SEMS, with 200 patients in each group. The primary outcome was confirmed stent failure during 300 days of follow-up.  At 300 days, the proportion of patients with patent stents was 77 % in the steel group, compared with 89 % in the nitinol group (P = 0.01). Confirmed stent failure occurred more often in the steel SEMS group compared with the nitinol SEMS group, in 30 versus 14 patients (P = 0.02). Stent migration occurred in 13 patients in the steel group and in 3 patients in the nitinol group (P = 0.01). Median patient survival (secondary outcome) was 137 days and 120 days in the steel SEMS and nitinol SEMS groups, respectively (P = 0.59). The nitinol SEMS showed longer patency time, and the nitinol group had fewer patients with stent failure, compared with the steel SEMS group. We could not detect any differences between the two groups regarding survival time, and regarding adverse event rate.Clinical trial registration : NCT 00980889. © Georg Thieme Verlag KG Stuttgart · New York.

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.

Clinical feasibility of a new through-the-scope fully covered esophageal self-expandable metallic stent: an in vivo animal study.

PubMed

Cheon, Young Koog; Lee, Tae Yoon; Sung, In Kyung; Shim, Chan Sup

2014-01-01

Most delivery devices used for esophageal stents for obstructing esophageal cancer have a diameter of 5-8 mm, a size that is too large to pass through the endoscopic working channel. The conventional esophageal stent requires multiple endoscopic procedures for implantation. The purpose of the present study was to evaluate the clinical feasibility of a newly developed fully covered, self-expanding, through-the-scope (TTS) esophageal stent in a porcine model. Eight mini pigs were used. Each animal underwent placement of a fully covered TTS stent (Hanarostent® Esophagus TTS) and the upper part of the stent was fixed by suturing with nylon. Fluoroscopy was carried out every week to assess migration of the stent. Follow-up endoscopy was done every month for 3 months to evaluate the status of the membrane, stent mesh, grade of tissue hyperplasia, and mucosal changes at both ends of the stent. All stents were successfully and easily deployed, and were placed without any distortion in the stent or without rupture of the membrane. In two cases, stent migration was observed after 8 weeks. No case of membrane disruption, stent mesh disruption or tissue hyperplasia at either end of the stent was found at the completion of the study. Our findings indicate that the new fully covered self-expanding TTS esophageal stent is easy and simple to implant, and no significant distortion of mesh or disruption of membrane was observed. © 2013 The Authors. Digestive Endoscopy © 2013 Japan Gastroenterological Endoscopy Society.

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.

Canine model of acute aortic rupture: treatment with percutaneous delivery of a covered Z stent--work in progress.

PubMed

Williams, D M; Andrews, J C; Chee, S S; Marx, M V; Abrams, G D

1994-01-01

To develop a percutaneous treatment for aortic rupture with use of a covered intraluminal stent. A transmural tear was created percutaneously in the thoracic aorta in six dogs with use of a 4-mm angioplasty balloon. Gianturco Z stents were covered with polytetrafluoroethylene, loaded into a 14-F sheath, and advanced through the femoral artery to the site of injury. Within 2 minutes after initiation of the injury, the stent was deployed. Homologous canine blood was given during the procedure. Dogs that survived 24 hours were then killed. The first stent did not expand completely, and the dog died in 1 hour. At necropsy, the first two dogs (1-hour and 8-hour survival) had a large left hemothorax and extensive periaortic hematoma, indicating intrathoracic exsanguination. The next four dogs were treated with a modified stent and survived 2 hours (n = 1), 8 hours (n = 1), and 24 hours (n = 2). At necropsy hemothorax did not exceed 15 mL, and periaortic hematomas were small. The cause of death in the two early casualties with the modified stent is uncertain. There were no signs of spinal cord injury despite occlusion of three pairs of intercostal arteries. The covered Z stent (in its modified form) tamponaded the aortic tear, preventing exsanguination. Long-term studies of biocompatibility of this device appear justified.

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.

Covered stent graft for treatment of a pseudoaneurysm and carotid blowout syndrome

PubMed Central

Janjua, Nazli; Alkawi, Ammar; Georgiadis, Alexandros L.; Kirmani, Jawad F.; Qureshi, Adnan I.

2008-01-01

Background Carotid blowout syndrome with pseudoaneurysm, a rapidly progressive pathology, may present emergently with massive oral hemorrhage. Use of an endograft prosthesis offers a treatment strategy with salvation of the carotid artery. Case History: A 55 year old man with advanced squamous cell carcinoma of the head and neck presented with recurrent transoral hemorrhage, requiring endovascular treatment. Technical Report: Coil embolization was initially performed with little impact on the hemorrhage. A 7 x 40 mm Fluency® Plus covered stent (Bard Peripheral Vascular, Tempe, Arizona, USA) was placed and was supplemented by a second 8 x 40 mm Fluency Plus stent, with resulting cessation of active contrast extravasation. Discussion: The risks and benefits of various treatment options of carotid pseudoaneurysm with blowout are discussed including the use or omission of antiplatelet and anticoagulant regimens, with reference to previously reported cases. Conclusion: Tandem, overlapping covered stent placement in the common carotid artery is feasible and offers a treatment option for carotid blowout syndrome. Risks of aggravation of hemorrhage versus long-term thromboembolic events without antiplatelet therapy must be considered in cases of active ongoing hemorrhage. PMID:22518207

Fully covered self-expanding metal stents are effective for benign esophagogastric disruptions and strictures.

PubMed

Wilson, Jennifer L; Louie, Brian E; Farivar, Alexander S; Vallières, Eric; Aye, Ralph W

2013-12-01

Self-expanding fully covered metal stents (CSs) are ideal for use in benign esophagogastric disease. We reviewed our experience with CS to evaluate outcomes, to determine a role for CS in a standard treatment for benign esophageal conditions, and to compare our results with recently published studies. We performed a retrospective chart review from 2005 to 2012. A total of 57 CSs were placed in 44 patients. Indications were stricture (11 patients), anastomotic leak (20), perforation (7), and tracheoesophageal fistulae (6). For GI tract disruptions, open repair or diversion was avoided in 31/33 patients (93.9 %) but required an associated drainage procedure in 22/33 (67 %) patients. Resolution does not depend on achieving radiological control with 6/26 (23 %) having evidence of a persistent leak. Benign strictures were dilated at a mean of 3.7 times prior to stenting. Adjunctive intra-mucosal steroid injections were used in 8/11 patients. Stents were removed at a mean of 33 days. At a mean of 283 days of follow-up, 6/11 (54.5 %) had symptom resolution. The most common complication was stent migration occurring in 17.5 % of patients overall. Covered stents are an effective adjunct in the management of benign upper gastrointestinal tract fistulae, leaks, perforations and benign strictures.

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.

Bending behaviors of fully covered biodegradable polydioxanone biliary stent for human body by finite element method.

PubMed

Liu, Yanhui; Zhu, Guoqing; Yang, Huazhe; Wang, Conger; Zhang, Peihua; Han, Guangting

2018-01-01

This paper presents a study of the bending flexibility of fully covered biodegradable polydioxanone biliary stents (FCBPBs) developed for human body. To investigate the relationship between the bending load and structure parameter (monofilament diameter and braid-pin number), biodegradable polydioxanone biliary stents derived from braiding method were covered with membrane prepared via electrospinning method, and nine FCBPBSs were then obtained for bending test to evaluate the bending flexibility. In addition, by the finite element method, nine numerical models based on actual biliary stent were established and the bending load was calculated through the finite element method. Results demonstrate that the simulation and experimental results are in good agreement with each other, indicating that the simulation results can be provided a useful reference to the investigation of biliary stents. Furthermore, the stress distribution on FCBPBSs was studied, and the plastic dissipation analysis and plastic strain of FCBPBSs were obtained via the bending simulation. Copyright © 2017 Elsevier Ltd. All rights reserved.

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

Stent selection for both biliary and pancreatic strictures caused by chronic pancreatitis: multiple plastic stents or metallic stents?

PubMed

Gupta, Rajesh; Reddy, D Nageshwar

2011-09-01

Endoscopic stenting is an effective treatment option in the management of both benign biliary strictures and pancreatic ductal strictures. Plastic stents and self-expandable metal stents have been used with variable success for the management of both benign biliary strictures and pancreatic ductal strictures caused by chronic pancreatitis. Fully covered self-expandable metal stents of improved design represent a major technological advance which has added to the endoscopic armamentarium. Both multiple plastic stents and covered self-expandable metal stents have shown promising results. However, data to support the use of self-expandable metal stents over multiple plastic stents or vice versa are still lacking.

Covered Stent-Graft Treatment of Traumatic Internal Carotid Artery Pseudoaneurysms: A Review

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

Maras, Dimitrios; Lioupis, Christos; Magoufis, George

Objective. To review the literature concerning the management with placement of covered stent-grafts of traumatic pseudoaneurysms of the extracranial internal carotid artery (ICA) resulting from penetrating craniocervical injuries or skull base fractures. Method. We have reviewed, from the Medline database, all the published cases in the English literature since 1990 and we have added a new case. Results. We identified 20 patients with traumatic extracranial ICA pseudoaneurysms due to penetrating craniocervical injuries or skull base fractures who had been treated with covered stent-graft implantation. Many discrepancies have been ascertained regarding the anticoagulation therapy. In 3 patients the ICA was totallymore » occluded in the follow-up period, giving an overall occlusion rate 15%. No serious complication was reported as a result of the endovascular procedure. Conclusion. Preliminary results suggest that placement of stent-grafts is a safe and effective method of treating ICA traumatic pseudoaneurysms resulting from penetrating craniocervical injuries or skull base fractures. The immediate results are satisfactory when the procedure takes place with appropriate anticoagulation therapy. The periprocedural morbidity and mortality and the early patency are also acceptable. A surveillance program with appropriate interventions to manage restenosis may improve the long-term patency.« less

Efficacy of endoscopic management of leak after foregut surgery with endoscopic covered self-expanding metal stents (SEMS).

PubMed

Aryaie, Amir H; Singer, Jordan L; Fayezizadeh, Mojtaba; Lash, Jon; Marks, Jeffrey M

2017-02-01

Anastomotic or staple-line leak after foregut surgery presents a formidable management challenge. In recent years, with advancement of endoscopy, self-expanding covered stents have been gaining popularity. In this study, we aimed to determine the safety and effectiveness of self-expanding covered stents in management of leak after foregut surgery. Consecutive patients who received a fully covered self-expandable metal stent (SEMS) due to an anastomotic leak after upper gastrointestinal surgery between 2009 and 2014 were retrospectively reviewed. Demographic data, stent placement and removal, clinical success, time to resolution, and complications were collected. Predictive factors for clinical success rate were assessed. A total of 20 consecutive patients underwent placement of fully covered SEMS for anastomotic leak, following esophagectomy (n = 5), esophageal diverticulectomy (n = 1), gastric sleeve (n = 4), gastric bypass (n = 3), partial gastrectomy (n = 4), and total gastrectomy (n = 3). All the stents were removed successfully, and clinical resolution was achieved in 18 patients (90 %) after a median of two (range 1-3) procedures and a mean of 6.2 weeks (range 0.4-14). Complications presented in 12 patients (60 %), including stent migration (n = 8), mucosal friability (n = 4), tissue integration (n = 2), and bleeding (n = 2). Two (10 %) patients' treatment was complicated by aorto-esophageal fistula formation resulting in one death. Demographic factors, comorbidities, and type of surgery were not predictive of clinical success rate or time to resolution. SEMS are effective tools for the management of leaks after foregut surgery. The biggest challenge with this approach is stent migration. Caution is warranted due to the risk of fatal complications such as aorto-esophageal fistula formation. No type of surgery or particular patient factor, including age, sex, BMI, albumin, history of radiation, malignancy, and comorbid diabetes or

Use of a specially designed partially covered self-expandable metal stent (PSEMS) with a 40-mm diameter for the treatment of upper gastrointestinal suture or staple line leaks in 11 cases.

PubMed

Fischer, Andreas; Bausch, Dirk; Richter-Schrag, Hans-Juergen

2013-02-01

The use of self-expandable stents to treat postoperative leaks and fistula in the upper gastrointestinal (GI) tract is an established treatment for leaks of the upper GI tract. However, lumen-to-stent size discrepancies (i.e., after sleeve gastrectomy or esophageal resection) may lead to insufficient sealing of the leaks requiring further surgical intervention. This is mainly due to the relatively small diameter (≤30 mm) of commonly used commercial stents. To overcome this problem, we developed a novel partially covered stent with a shaft diameter of 36 mm and a flare diameter of 40 mm. From September 2008 to September 2010, 11 consecutive patients with postoperative leaks were treated with the novel large diameter stent (gastrectomy, n = 5; sleeve gastrectomy, n = 2; fundoplication after esophageal perforation, n = 2; Roux-en-Y gastric bypass, n = 1; esophageal resection, n = 1). Treatment with commercially available stents (shaft/flare: 23/28 mm and 24/30 mm) had been unsuccessful in three patients before treatment with the large diameter stent. Due to dislocation, the large diameter stent was anchored in four patients (2× intraoperatively with transmural sutures, 2× endoscopically with transnasally externalized threads). Treatment was successful in 11 of 11 patients. Stent placement and removal was easy and safe. The median residence time of the stent was 24 (range, 18-41) days. Stent dislocation occurred in four cases (36 %). It was treated by anchoring the stent. Mean follow-up was 25 (range, 14-40) months. No severe complication occurred during or after intervention and no patient was dysphagic. Using the novel large diameter, partially covered stent to seal leaks in the upper GI tract is safe and effective. The large diameter of the stent does not seem to injure the wall of the upper GI tract. However, stent dislocation sometimes requires anchoring of the stent with sutures or transnasally externalized threads.

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.

Percutaneous bail-out treatment of vein graft rupture with a polytetrafluoroethylene-covered stent.

PubMed

Pavlidis, Antonios N; Karamasis, Grigorios V; Clapp, Brian R

2013-12-01

Vessel perforation is an undesirable and life-threatening complication during vein graft angioplasty. We report on a case of vein graft rupture during angioplasty, which was successfully managed with deployment of a polytetrafluoroethylene-covered stent.

Covered stent to exclude intravascular thrombus.

PubMed

Liistro, Francesco; Stankovic, Goran; Di Mario, Carlo; Montorfano, Matteo; Briguori, Carlo; Colombo, Antonio

2002-04-01

To describe the utility of stent-graft implantation to avoid distal embolization from a large thrombus-containing lesion. A 67-year-old man was evaluated for recent onset of disabling left leg claudication. Angiography disclosed a mobile lobular mass occluding the left common iliac artery; irregular staining suggested an atherothrombotic lesion. Through a percutaneous ipsilateral access and an 8-F sheath, a balloon-expandable Jostent peripheral stent-graft was positioned with the distal edge immediately proximal to the internal iliac artery ostium. A prominent "waist" at the center of the balloon confirmed entrapment of the thrombotic mass. Completion angiography showed an optimal result with no residual stenosis or evidence of distal embolization. At 6-month follow-up, the patient was asymptomatic with angiographically documented luminal patency and no evidence of in-stent stenosis. Stent-graft implantation appears a viable treatment alternative for thrombus-containing lesions, particularly when the thrombotic material is localized or is in a large vessel.

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

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.

Sustained Benefit at 2 Years for Covered Stents Versus Bare-Metal Stents in Long SFA Lesions: The VIASTAR Trial

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

Lammer, Johannes, E-mail: jlammer@gmx.at, E-mail: johannes.lammer@meduniwien.ac.at; Zeller, Thomas, E-mail: thomas.zeller@universitaets-herzzentrum.de; Hausegger, Klaus A., E-mail: klaus.hausegger@lkh-klu.at

PurposeThe hypothesis that covered stents are superior to bare-metal stents (BMS) in long femoropopliteal artery disease was tested. The one-year results of the VIASTAR trial revealed a patency benefit of covered stents in the treatment-per-protocol (TPP) analysis only.MethodsA prospective, randomized, single-blind, multicenter study evaluated 141 patients with symptomatic peripheral arterial disease (PAD) after treatment with heparin-bonded covered stents (VIABAHN{sup ®} Endoprosthesis) or BMS. Clinical outcomes and patency rates were assessed at 1, 6, 12, and 24 months. Mean lesion length was 19.0 ± 6.3 cm in the VIABAHN{sup ®} versus 17.3 ± 6.6 cm in the BMS group.ResultsThe 24-month primary patency rates in the VIABAHN{sup ®} andmore » BMS group were: intention-to-treat 63.1 (95 % CI 0.52–0.76) versus 41.2 % (95 % CI 0.29–0.57; log rank p = 0.04) and TPP 69.4 (95 % CI 0.58–0.83) versus 40.0 % (95 % CI 0.28–0.56; log rank p = 0.004). Freedom from target-lesion-revascularization (TLR) was 79.4 (95 % CI 0.70–0.90) versus 73.0 % (95 % CI 0.63–0.85) for VIABAHN{sup ®} versus BMS (log rank p = 0.37). For the TPP group in lesions ≥20 cm, the 24-month patency rates were 65.2 (95 % CI 0.50–0.85) versus 26.7 % (95 % CI 0.12–0.59; log rank p = 0.004) for VIABAHN{sup ®} versus BMS, and freedom from TLR was 80.0 (95 % CI 0.68–0.94) versus 61.9 % (95 % CI 0.44–0.87; log rank p = 0.13). The ankle brachial index was 0.89 ± 0.18 versus 0.91 ± 0.17 (p = 0.76) at 24-month in the VIABAHN{sup ®} versus the BMS group, respectively.ConclusionAt 24-month, this trial in PAD patients with long femoropopliteal lesions demonstrated a significantly improved primary patency rate for heparin-bonded covered stents compared to BMS, however, without a significant impact on clinical outcomes and TLR rate (Reg. Nr. ISRCTN48164244)« less

Airway complications after covered stent placement for malignant esophageal stricture: special reference to radiation therapy.

PubMed

Park, Ji Yeon; Shin, Ji Hoon; Song, Ho-Young; Yi, Seong Yoon; Kim, Jin Hyoung

2012-02-01

The purpose of this study was to evaluate the characteristics of airway complications and survival with special reference to radiation therapy in the care of patients undergoing covered stent placement for malignant esophageal strictures. A total of 208 patients who underwent stent placement with or without palliative radiation therapy for inoperable esophageal cancer were included. The endpoints were frequency, type, and management of airway complications; association between occurrence of airway complications and radiation therapy history; and differences in stent-to-complication interval and survival period after esophageal stenting between patients who underwent radiation therapy before and those who underwent radiation therapy after stent placement. Airway complications occurred in 23 patients (11.1%): 18 (78.3%) had esophagorespiratory fistula, three (13.0%) had airway narrowing, and two (8.7%) had both complications. The frequency of airway complications was significantly greater among patients who underwent RT than those who did not (p = 0.005) but was not significantly different between the radiation before stenting and radiation after stenting groups (p = 0.158). The median stent-to-complication interval and survival period after esophageal stenting were significantly shorter in the radiation before stenting group than in the radiation after stenting group (p = 0.002, p = 0.001). Esophagorespiratory fistula is much more common than airway narrowing as an airway complication. The rate of complications increases significantly in association with radiation therapy among patients with malignant esophageal stricture. Clinicians need to be aware of earlier airway complications and poorer prognosis among patients who undergo radiation therapy before placement of an esophageal stent than in patients who undergo radiation after stent placement.

Use of the Viatorr Expanded Polytetrafluoroethylene-Covered Stent-Graft for Transjugular Intrahepatic Portosystemic Shunt Creation in Children: Initial Clinical Experience

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

Mermuys, Koen; Maleux, Geert, E-mail: geert.maleux@uzleuven.be; Heye, Sam

2008-07-15

Four children, three boys and one girl, with a median age of 9 years 8 months, underwent transjugular intrahepatic portosystemic shunt creation with an expanded polytetrafluoroethylene (e-PTFE)-covered nitinol stent. The stent-graft was successfully placed in all four patients without any complication. Clinical and biochemical improvement was noted in all four patients during follow-up. Radiological follow-up with use of duplex ultrasound showed a recurrent stenosis of the shunt 180 days after stent-graft implantation in one patient. This was treated with placement of an additional stent-graft, re-expanding completely the recurrent stenosis. In the other three patients, the stent-graft remained fully patent untilmore » the end of the study or until orthotopic liver transplantation. These preliminary results suggest that use of the Viatorr ePTFE-covered stent-graft in children is safe and feasible, with potentially the same high patency rate and improved clinical outcome as reported in adult patients.« less

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.

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.

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

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.

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.

Durability of the balloon-expandable covered versus bare-metal stents in the Covered versus Balloon Expandable Stent Trial (COBEST) for the treatment of aortoiliac occlusive disease.

PubMed

Mwipatayi, Bibombe P; Sharma, Surabhi; Daneshmand, Ali; Thomas, Shannon D; Vijayan, Vikram; Altaf, Nishath; Garbowski, Marek; Jackson, Mark

2016-07-01

The Covered vs Balloon Expandable Stent Trial (COBEST) is the first multicenter trial to investigate the patency of covered stents (CSs) and bare-metal stents (BMSs) in the treatment of aortoiliac arterial disease. The short-term results demonstrated that CSs were superior to BMSs in maintaining patency for TransAtlantic Inter-Society Consensus (TASC) C and D lesions at 18 months and were equivalent to BMSs for TASC B lesions. The current study was conducted to determine if the initial patency advantage of CSs over BMSs was sustained at the 5-year follow-up. A retrospective post hoc analysis of COBEST was performed. Originally, 125 patients with 168 iliac arteries were prospectively enrolled and randomly assigned to receive a CS or BMS. In this study, 77 of the 125 patients (61.6%; 119 limbs) were assessed at 60 months for the primary and secondary end points, with particular attention paid to the outcomes stratified according to TASC lesion severity. The primary end point was the rate of binary stenosis or freedom from stent occlusion of the treated area, as determined by ultrasound imaging or quantitative visual angiography. The 5-year results of the COBEST showed that the CS had a significantly higher patency rate than the BMS at 18, 24, 48, and 60 months (95.1%, 82.1%, 79.9%, 74.7% for CS vs 73.9%, 70.9%, 63% and 62.5% for BMS; log-rank test, P = .01). On multivariate analysis, the type of stent used (hazard ratio [HR], 2.797; 95% confidence interval [CI], 1.471-5.318; P = .002) and the Rutherford classification (HR, 2.019; 95% CI, 1.278-3.191; P = .026) significantly affected the adjusted primary patency. On subgroup analysis, the CS showed significantly higher patency and a survival benefit compared with the BMS in TASC C and D lesions (HR, 8.639; 95% CI, 54.253-75.753; P = .003). Moreover, fewer patients received target limb revascularization in the CS group than in the BMS group (odds ratio, 2.32; 95% CI, 1.47-3.36; P = .02); however, there was no

[Transjugular intrahepatic portosystemic shunting with covered stents in children: a preliminary study of safety and patency].

PubMed

Zurera, L J; Espejo, J J; Canis, M; Bueno, A; Vicente, J; Gilbert, J J

2014-01-01

To retrospectively analyze the safety and efficacy of transjugular intrahepatic portosystemic shunting (TIPS) using covered stents in children. We present 6 children (mean age, 10.6 years; mean weight, 33.5kg) who underwent TIPS with 8mm diameter Viatorr(®) covered stents for acute (n=4) or recurrent (n=2) upper digestive bleeding that could not be controlled by endoscopic measures. Five of the children had cirrhosis and the other had portal vein thrombosis with cavernous transformation. We analyzed the relapse of upper digestive bleeding, the complications that appeared, and the patency of the TIPS shunt on sequential Doppler ultrasonography or until transplantation. A single stent was implanted in a single session in each child; none of the children died. The mean transhepatic gradient decreased from 16mmHg (range: 12-21mmHg) before the procedure to 9mmHg (range: 1-15mmHg) after TIPS. One patient developed mild encephalopathy, and the girl who had portal vein thrombosis with cavernous transformation developed an acute occlusion of the TIPS that resolved after the implantation of a coaxial stent. Three children received transplants (7, 9, and 10 months after the procedure, respectively), and the patency of the TIPS was confirmed at transplantation. In the three remaining children, patency was confirmed with Doppler ultrasonography 1, 3, and 5 months after implantation. None of the children had new episodes of upper digestive bleeding during follow-up after implantation (mean: 8.1 months). Our results indicate that TIPS with 8mm diameter Viatorr(®) covered stents can be safe and efficacious for the treatment of upper digestive bleeding due to gastroesophageal varices in cirrhotic children; our findings need to be corroborated in larger series. Copyright © 2011 SERAM. Published by Elsevier Espana. All rights reserved.

Effect of Antithrombotic Agents on the Patency of PTFE-Covered Stents in the Inferior Vena Cava: An Experimental Study

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

Makutani, Shiro; Kichikawa, Kimihiko; Uchida, Hideo

Purpose: To evaluate the efficacy of antithrombotic agents in the prevention of stenosis of polytetrafluoroethylene (PTFE)-covered stents in the venous system. Methods: Spiral Z stents covered with PTFE (PTFE-covered stents) were placed in the inferior vena cava (IVC) of 34 dogs. Nineteen dogs, used as a control group, were sacrificed at 2, 4, and 12 weeks. Fifteen dogs, previously given antithrombotic agents [cilostazol (n= 5), warfarin potassium (n= 5), cilostazol plus warfarin potassium (n= 5)] were sacrificed at 4 weeks, and then examined angiographically and histopathologically. The effect of the antithrombotic agents was compared between groups. Results: The patency ratemore » of the antithrombotic agent group was 93% (14/15), which was higher than the control group rate of 63% (12/19). The mean stenosis rate of the patent stent at both ends and at the midportion was lower at 4 weeks in the antithrombotic agent group than in the control group. In particular, the mean stenosis rate in the cilostazol plus warfarin potassium group was significantly lower than the control group (Tukey's test, p < 0.05). The mean neointimal thickness of the patent stent at both ends and at the midportion was thinner at 4 weeks in the antithrombotic agent group than in the control group. In particular, the thickness of the neointima in the cilostazol plus warfarin potassium group was significantly decreased when compared with the control group (Tukey's test p < 0.05). At 4 weeks, endothelialization in the antithrombotic agent group tended to be almost identical to that in the control group. Conclusion: The present study suggests that administration of an antithrombotic agent is an effective way of preventing the stenosis induced by a neointimal thickening of PTFE-covered stents in the venous system.« less

Partially covered versus uncovered self-expandable nitinol stents with anti-migration properties for the palliation of malignant distal biliary obstruction: A randomized controlled trial.

PubMed

Yang, Min Jae; Kim, Jin Hong; Yoo, Byung Moo; Hwang, Jae Chul; Yoo, Jun Hwan; Lee, Ki Seong; Kang, Joon Koo; Kim, Soon Sun; Lim, Sun Gyo; Shin, Sung Jae; Cheong, Jae Youn; Lee, Kee Myung; Lee, Kwang Jae; Cho, Sung Won

2015-01-01

Covered self-expandable metal stents (SEMSs) are increasingly used as alternatives to uncovered SEMSs for the palliation of inoperable malignant distal biliary obstruction to counteract tumor ingrowth. We aimed to compare the outcomes of partially covered and uncovered SEMSs with identical mesh structures and anti-migration properties, such as low axial force and flared ends. One hundred and three patients who were diagnosed with inoperable malignant distal biliary obstruction between January 2006 and August 2013 were randomly assigned to either the partially covered (n = 51) or uncovered (n = 52) SEMS group. There were no significant differences in the cumulative stent patency, overall patient survival, stent dysfunction-free survival and overall adverse events, including pancreatitis and cholecystitis, between the two groups. Compared to the uncovered group, stent migration (5.9% vs. 0%, p = 0.118) and tumor overgrowth (7.8% vs. 1.9%, p = 0.205) were non-significantly more frequent in the partially covered group, whereas tumor ingrowth showed a significantly higher incidence in the uncovered group (5.9% vs. 19.2%, p = 0.041). Stent migration in the partially covered group occurred only in patients with short stenosis of the utmost distal bile duct (two in ampullary cancer, one in bile duct cancer), and did not occur in any patients with pancreatic cancer. For the palliation of malignant distal biliary obstruction, endoscopic placement of partially covered SEMSs with anti-migration designs and identical mesh structures to uncovered SEMSs failed to prolong cumulative stent patency or reduce stent migration.

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

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.

In vivo geometry of the kissing stent and covered endovascular reconstruction of the aortic bifurcation configurations in aortoiliac occlusive disease.

PubMed

Groot Jebbink, Erik; Ter Mors, Thijs G; Slump, Cornelis H; Geelkerken, Robert H; Holewijn, Suzanne; Reijnen, Michel Mpj

2017-12-01

Objectives Various configurations of kissing stent (KS) configurations exist and patency rates vary. In response the covered endovascular reconstruction of the aortic bifurcation configuration was designed to minimize mismatch and improve outcome. The aim of the current study is to compare geometrical mismatch of kissing stent with the covered endovascular reconstruction of the aortic bifurcation configuration in vivo. Methods Post-operative computed tomographic data and patient demographics from 11 covered endovascular reconstruction of the aortic bifurcation and 11 matched kissing stent patients were included. A free hand region of interest and ellipse fitting method were applied to determine mismatch areas and volumes. Conformation of the stents to the vessel wall was expressed using the D-ratio. Results Patients were mostly treated for Rutherford category 2 and 3 (64%) with a lesion classification of TASC C and D in 82%. Radial mismatch area and volume for the covered endovascular reconstruction of the aortic bifurcation group was significantly lower compared to the kissing stent configuration ( P < 0.05). The D-ratio did not significantly differ between groups. Measurements were performed with good intra-class correlation. There were no significant differences in the post-procedural aortoiliac anatomy. Conclusions The present study shows that radial mismatch exists in vivo and that large differences in mismatch exist, in favour of the covered endovascular reconstruction of the aortic bifurcation configuration. Future research should determine if the decreased radial mismatch results in improved local flow profiles and subsequent clinical outcome.

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.

Assessment of safety and efficacy of an indigenous self-expandable fully covered esophageal metal stent for palliation of esophageal cancer.

PubMed

Padhan, R K; Nongthombam, S K; Venuthurimilli, A; Dhingra, R; Sahni, P; Garg, P K

2016-01-01

Patients with unresectable esophageal cancer require palliation for dysphagia. Placement of a self-expandable metal stent (SEMS) is the procedure of choice for palliation of dysphagia. To evaluate the safety and efficacy of an indigenous fully-covered SEMS in patients with esophageal cancer. Eligible patients with unresectable esophageal cancer requiring palliation for dysphagia were included in the study. An indigenous fully covered SEMS of appropriate length was placed under endoscopic and fluoroscopic guidance. Outcome measures assessed were adverse events and improvement in dysphagia. Twenty one patients (mean age 57.71±13.14 years; 17 males) were included. After stenting, dysphagia score decreased from 3.2+0.4 to 0.35+0.74 at 4 weeks. Adverse events included retrosternal pain, respiratory distress and aspiration pneumonia in 12, 2 and 1 patients respectively. Five patients required repeat stenting due to stent migration in 4 (following radiotherapy in 3) and tumour ingrowth in 1. There was primary stent malfunction in one patient. The median survival of patients was 140 (76-199) days, which was higher in those who received radiotherapy. The stent was reasonably safe and effective to relieve dysphagia due to unresectable esophageal cancer.

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

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.

In vivo geometry of the kissing stent and covered endovascular reconstruction of the aortic bifurcation configurations in aortoiliac occlusive disease

PubMed Central

Ter Mors, Thijs G; Slump, Cornelis H; Geelkerken, Robert H; Holewijn, Suzanne; Reijnen, Michel MPJ

2017-01-01

Objectives Various configurations of kissing stent (KS) configurations exist and patency rates vary. In response the covered endovascular reconstruction of the aortic bifurcation configuration was designed to minimize mismatch and improve outcome. The aim of the current study is to compare geometrical mismatch of kissing stent with the covered endovascular reconstruction of the aortic bifurcation configuration in vivo. Methods Post-operative computed tomographic data and patient demographics from 11 covered endovascular reconstruction of the aortic bifurcation and 11 matched kissing stent patients were included. A free hand region of interest and ellipse fitting method were applied to determine mismatch areas and volumes. Conformation of the stents to the vessel wall was expressed using the D-ratio. Results Patients were mostly treated for Rutherford category 2 and 3 (64%) with a lesion classification of TASC C and D in 82%. Radial mismatch area and volume for the covered endovascular reconstruction of the aortic bifurcation group was significantly lower compared to the kissing stent configuration (P < 0.05). The D-ratio did not significantly differ between groups. Measurements were performed with good intra-class correlation. There were no significant differences in the post-procedural aortoiliac anatomy. Conclusions The present study shows that radial mismatch exists in vivo and that large differences in mismatch exist, in favour of the covered endovascular reconstruction of the aortic bifurcation configuration. Future research should determine if the decreased radial mismatch results in improved local flow profiles and subsequent clinical outcome. PMID:28530484

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.

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.

Safety and Efficacy of Percutaneous Biliary Covered Stent Placement in Patients with Malignant Biliary Hilar Obstruction; Correlation with Liver Function.

PubMed

Hyun, Hyeran; Choi, Sun Young; Kim, Kyung Ah; Ko, Soo Bin

2016-09-01

To estimate the safety and efficacy of percutaneous ePTFE-covered biliary stent placement and the relationship between underlying liver function and stent patency in patients with malignant hilar obstruction. From March 2012 to June 2015, 41 patients [22 females, 19 males; mean age 69.8 (range 34-94) years] with malignant biliary obstruction underwent percutaneous biliary stent placement (31 patients with unilateral, 10 patients with bilateral side-by-side). Cumulative patient survival and stent patency rate curves were derived using the Kaplan-Meier method. A Cox model was used to explore the relationship between liver function and patient survival, and also biliary stent patency. Pearson correlation coefficient was used to analyze the relationship between patient survival and stent patency. Technical success rate was 100 % and clinical success rate was 95 %. During follow-up, four complications occurred (two bilomas and two cases of acute cholecystitis) and were treated successfully with percutaneous drainage. No other complication occurred. Mean serum bilirubin level was 11.34 ± 7.35 mg/dL before drainage and 5.00 ± 4.83 mg/dL 2 weeks after stent placement. The median patent survival duration was 147 days (95 % CI, 69.6-224.4 days). The median stent patency duration was 101 days (95 % CI, 70.0-132.0 days). The cumulative stent patency rates at 1, 3, 6, and 12 months were 97, 57.6, 30.3, and 17.0 %, respectively. Child-Pugh score was correlated significantly with patient survival (P = 0.011) and stent patency (P = 0.007). MELD score was correlated significantly with stent patency (P = 0.044). There was a correlation between patient survival and stent patency (r = 0.778, P < 0.001). Percutaneous placement of ePTFE-covered biliary stent was a safe and an effective method for malignant biliary obstruction. Underlying liver function seemed to be one of the important factors affecting patient survival and stent patency, and stent patency

Safety and Efficacy of Percutaneous Biliary Covered Stent Placement in Patients with Malignant Biliary Hilar Obstruction; Correlation with Liver Function

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

Hyun, Hyeran; Choi, Sun Young, E-mail: medmath@hanmail.net; Kim, Kyung Ah

PurposeTo estimate the safety and efficacy of percutaneous ePTFE-covered biliary stent placement and the relationship between underlying liver function and stent patency in patients with malignant hilar obstruction.Materials and MethodsFrom March 2012 to June 2015, 41 patients [22 females, 19 males; mean age 69.8 (range 34–94) years] with malignant biliary obstruction underwent percutaneous biliary stent placement (31 patients with unilateral, 10 patients with bilateral side-by-side). Cumulative patient survival and stent patency rate curves were derived using the Kaplan–Meier method. A Cox model was used to explore the relationship between liver function and patient survival, and also biliary stent patency. Pearsonmore » correlation coefficient was used to analyze the relationship between patient survival and stent patency.ResultsTechnical success rate was 100 % and clinical success rate was 95 %. During follow-up, four complications occurred (two bilomas and two cases of acute cholecystitis) and were treated successfully with percutaneous drainage. No other complication occurred. Mean serum bilirubin level was 11.34 ± 7.35 mg/dL before drainage and 5.00 ± 4.83 mg/dL 2 weeks after stent placement. The median patent survival duration was 147 days (95 % CI, 69.6–224.4 days). The median stent patency duration was 101 days (95 % CI, 70.0–132.0 days). The cumulative stent patency rates at 1, 3, 6, and 12 months were 97, 57.6, 30.3, and 17.0 %, respectively. Child–Pugh score was correlated significantly with patient survival (P = 0.011) and stent patency (P = 0.007). MELD score was correlated significantly with stent patency (P = 0.044). There was a correlation between patient survival and stent patency (r = 0.778, P < 0.001).ConclusionPercutaneous placement of ePTFE-covered biliary stent was a safe and an effective method for malignant biliary obstruction. Underlying liver function seemed to be one of the important factors

Nasal packing and stenting

PubMed Central

Weber, Rainer K.

2011-01-01

Nasal packs are indispensable in ENT practice. This study reviews current indications, effectiveness and risks of nasal packs and stents. In endoscopic surgery, nasal packs should always have smooth surfaces to minimize mucosal damage, improve wound healing and increase patient comfort. Functional endoscopic endonasal sinus surgery allows the use of modern nasal packs, since pressure is no longer required. So called hemostatic/resorbable materials are a first step in this direction. However, they may lead to adhesions and foreign body reactions in mucosal membranes. Simple occlusion is an effective method for creating a moist milieu for improved wound healing and avoiding dryness. Stenting of the frontal sinus is recommended if surgery fails to produce a wide, physiologically shaped drainage path that is sufficiently covered by intact tissue. PMID:22073095

Temporary placement of fully covered self-expandable metal stents in benign biliary strictures.

PubMed

Ryu, Choong Heon; Kim, Myung Hwan; Lee, Sang Soo; Park, Do Hyun; Seo, Dong Wan; Lee, Sung Koo

2013-07-01

Benign biliary strictures (BBSs) have been endoscopically managed with plastic stent placement. However, data regarding fully covered self-expandable metal stents (FCSEMSs) in BBS patients remain scarce in Korea. Forty-one patients (21 men, 65.9%) with BBSs underwent FCSEMS placement between February 2007 and July 2010 in Asan Medical Center. Efficacy and safety were evaluated retrospectively. Patients were considered to have resolution if they showed evidence of stricture resolution on cholangiography and if an inflated retrieval balloon easily passed through the strictures at FCSEMS removal. The mean FCSEMS placement time was 3.2 (1.9-6.2) months. Patients were followed for a mean of 10.2 (1.0-32.0) months after FCSEMS removal. The BBS resolution rate was confirmed in 38 of 41 (92.7%) patients who underwent FCSEMS removal. After FCSEMS removal, 6 of 38 (15.8%) patients experienced symptomatic recurrent stricture and repeat stenting was performed. When a breakdown by etiology of stricture was performed, 14 of 15 (93.3%) patients with chronic pancreatitis, 17 of 19 (89.5%) with gall stone-related disease, 4 of 4 (100%) with surgical procedures, and 2 of 2 (100%) with BBSs of other etiology had resolution at FCSEMS removal. Complications related to stent therapy occurred in 12 (29%) patients, including post-ERCP pancreatitis (n=4), proximal migration (n=3), distal migration (n=3), and occlusion (n=2). Temporary FCSEMS placement in BBS patients offers a potential alternative to plastic stenting. However, because of the significant complications and modest resolution rates, the potential benefits and risks should be evaluated in further investigations.

Long-term outcomes of covered self-expandable metal stents for treating benign biliary strictures.

PubMed

Park, Jin-Seok; Lee, Sang Soo; Song, Tae Jun; Park, Do Hyun; Seo, Dong-Wan; Lee, Sung Koo; Han, Seungbong; Kim, Myung-Hwan

2016-05-01

Fully covered, self-expandable metal stents (FCSEMSs) are acceptable tools for treating benign biliary stricture (BBS). However, little is known about the long-term outcomes of this technique. The aim of the present study was to evaluate the procedural and long-term outcomes of FCSEMSs for treating BBSs. A total of 134 consecutive patients (median age 56 years; range 21 - 83) with BBS were retrospectively reviewed. The main outcomes were technical and clinical success, stricture resolution, recurrence, and adverse events. Outcomes were analyzed by reviewing patient medical records. The success rates of FCSEMS placement and removal were 99.3 % and 98.2 %, respectively. Stricture resolution occurred in 103/132 (78.0 %) of the patients (median stent duration, 93 days; range 1 - 489). The associated factors for stricture resolution were longer stent indwelling period (≥ 120 days) and absence of stent migration. Stricture recurrence was seen in 26/103 patients (25.2 %; 95 % confidence interval [CI] 0.17 - 0.34) within a median of 390 days (range 4 - 903 days). Chronic pancreatitis was associated with stricture recurrence (hazard ratio [HR] 2.59, 95 %CI 1.20 - 5.61; P = 0.02). Stent migration occurred in 41/132 patients (31.1 %; 95 %CI 0.23 - 0.39). The FCSEMS with anchoring flaps appeared to protect against stent migration (HR 0.22, 95 %CI 0.08 - 0.63; P < 0.01). FCSEMSs had a high success rate for BBS resolution. Longer indwelling periods and the absence of stent migration might be important factors for stricture resolution. © Georg Thieme Verlag KG Stuttgart · New York.

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

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

Modulating the Release Kinetics of Paclitaxel from Membrane-Covered Stents Using Different Loading Strategies

PubMed Central

Sydow-Plum, Georg; Haidar, Ziyad S.; Merhi, Yahye; Tabrizian, Maryam

2008-01-01

Membrane-covered Express2TM Monorail® stents composed of chitosan (CH) blended with polyethylene oxide (PEO) in 70:30% wt (CH-PEO) were coated with a monolayer of hyaluronic acid (HA). This significantly improved the resistance to platelet adhesion and demonstrated excellent mechanical properties, resisting the harsh conditions during stent crimping and subsequent inflation. CH-PEO/HA membrane was then combined with a paclitaxel (Pac) delivery system via three different approaches for comparison of release profiles of Pac. The activity of Pac in these systems was confirmed since its presence in the membrane significantly decreased cell viability of U937 macrophages. Presented results are promising for applications requiring different release patterns of hydrophobic drugs.

Anchoring of a fully covered self-expandable metal stent with a 5F double-pigtail plastic stent to prevent migration in the management of benign biliary strictures.

PubMed

Park, Jong Kyu; Moon, Jong Ho; Choi, Hyun Jong; Min, Seul Ki; Lee, Tae Hoon; Cheon, Gab Jin; Cheon, Young Koog; Cho, Young Deok; Park, Sang-Heum; Kim, Sun-Joo

2011-10-01

Fully covered self-expandable metal stents (FCSEMSs) can be effectively placed in patients with benign biliary stricture (BBS). However, stent migration is an inherent problem of FCSEMSs. We evaluated the efficacy of anchoring with a 5F double-pigtail plastic stent (anchoring stent) to prevent migration of an FCSEMS in patients with BBS. Between January 2007 and December 2009, 33 of 37 consecutive patients with BBS who had experienced treatment failure of at least one plastic stent placement were prospectively enrolled in this study. The patients with BBS were randomly assigned to undergo FCSEMS placement with or without an anchoring stent (anchoring group: 16 patients; non-anchoring group: 17 patients). The main outcome measures were the stent migration rate and success rates. The technical success rate was 100% in both groups. Significantly less stent migration occurred in the anchoring group (6.3%, 1/16) than in the non-anchoring group (41.2%, 7/17; P=0.024). The median indwelling time was significantly longer in the anchoring group (154 days; range, 86-176 days) than in the non-anchoring group (114 days; range, 19-162 days; P=0.010). Improvement or resolution of the BBS was confirmed in 15 of 16 patients (93.8%) in the anchoring group, and in 12 of 17 patients (70.6%) in the non-anchoring group (P=0.101). The placement of an anchoring stent appears to be a simple and effective method of preventing premature migration of FCSEMSs in patients with BBS. Appropriately powered studies are needed to confirm this finding.

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.

The use of retrievable fully covered self-expanding metal stent in refractory postoperative restenosis of benign esophageal stricture in children.

PubMed

Zhang, Jie; Ren, Lixin; Huo, Jirong; Zhu, Zhiyuan; Liu, Deliang

2013-11-01

This study analyzes the efficacy and safety of a retrievable, fully covered self-expanding metal stent (cSEMS) in the treatment of refractory benign esophageal restenosis in children. This is a retrospective analysis of the application of a newly designed cSEMS in treating refractory benign postoperative restenosis in five children with ages ranging from 16 months to 8 years. Efficacy and safety were evaluated during the follow-up period. cSEMS with or without an antireflux valve at the distal end were successfully placed and removed in five children. These five patients were followed up for 4-12 months after stent removal. Among the five patients, ulcerative stricture was observed in two patients because of reflux esophagitis, while three patients showed no signs of stricture recurrence. Stent migration was observed in three patients, two of which required the stent to be reset. The narrow esophagus was successfully expended to a diameter of 12-13 mm. Besides the observation of mild granulation tissue growth in one case, no severe complications were observed during surgery and after stent placement. Our study suggests that a retrievable, fully covered SEMS is safe and partially effective for treating refractory benign postoperative esophageal restenosis in children during short-term observation. © 2013.

Successful management of benign biliary strictures with fully covered self-expanding metal stents.

PubMed

Devière, Jacques; Nageshwar Reddy, D; Püspök, Andreas; Ponchon, Thierry; Bruno, Marco J; Bourke, Michael J; Neuhaus, Horst; Roy, André; González-Huix Lladó, Ferrán; Barkun, Alan N; Kortan, Paul P; Navarrete, Claudio; Peetermans, Joyce; Blero, Daniel; Lakhtakia, Sundeep; Dolak, Werner; Lepilliez, Vincent; Poley, Jan W; Tringali, Andrea; Costamagna, Guido

2014-08-01

Fully covered self-expanding metal stents (FCSEMS) are gaining acceptance for the treatment of benign biliary strictures. We performed a large prospective multinational study to study the ability to remove these stents after extended indwell and the frequency and durability of stricture resolution. In a nonrandomized study at 13 centers in 11 countries, 187 patients with benign biliary strictures received FCSEMS. Removal was scheduled at 10-12 months for patients with chronic pancreatitis or cholecystectomy and at 4-6 months for patients who received liver transplants. The primary outcome measure was removal success, defined as either scheduled endoscopic removal of the stent with no removal-related serious adverse events or spontaneous stent passage without the need for immediate restenting. Endoscopic removal of FCSEMS was not performed for 10 patients because of death (from unrelated causes), withdrawal of consent, or switch to palliative treatment. For the remaining 177 patients, removal success was accomplished in 74.6% (95% confidence interval [CI], 67.5%-80.8%). Removal success was more frequent in the chronic pancreatitis group (80.5%) than in the liver transplantation (63.4%) or cholecystectomy (61.1%) groups (P = .017). FCSEMS were removed by endoscopy from all patients in whom this procedure was attempted. Stricture resolution without restenting upon FCSEMS removal occurred in 76.3% of patients (95% CI, 69.3%-82.3%). The rate of resolution was lower in patients with FCSEMS migration (odds ratio, 0.22; 95% CI, 0.11-0.46). Over a median follow-up period of 20.3 months (interquartile range, 12.9-24.3 mo), the rate of stricture recurrence was 14.8% (95% CI, 8.2%-20.9%). Stent- or removal-related serious adverse events, most often cholangitis, occurred in 27.3% of patients. There was no stent- or removal-related mortality. In a large prospective multinational study, removal success of FCSEMS after extended indwell and stricture resolution were achieved for

Endovascular treatment of arterio-ureteral fistulae with covered stents: Case series and review of the literature.

PubMed

Patel, Dhruv; Kumar, Abhishek; Ranganath, Praveen; Contractor, Sohail

2014-01-01

Arterio-ureteral fistulae are abnormal connections between an artery and the ureter and carry a high mortality. We present two cases of arterio-ureteral fistulae that presented with life-threatening hematuria. Both patients were treated with endovascular covered stent placement.

Combined use of covered stent and flow diversion to seal iatrogenic carotid injury with vessel preservation during transsphenoidal endoscopic resection of clival tumor.

PubMed

Shakir, Hakeem J; Garson, Alex D; Sorkin, Grant C; Mokin, Maxim; Eller, Jorge L; Dumont, Travis M; Popat, Saurin R; Leonardo, Jody; Siddiqui, Adnan H

2014-01-01

Transsphenoidal tumor resection can lead to internal carotid artery (ICA) injury. Vascular disruption is often treated with emergent vessel deconstruction, incurring complications in a subset of patients with poor collateral circulation and resulting in minor and major ischemic strokes. We attempted a novel approach combining a covered stent graft (Jostent) and two flow diverter stents [Pipeline embolization devices (PEDs)] to treat active extravasation from a disrupted right ICA that was the result of a transsphenoidal surgery complication. This disruption occurred during clival tumor surgery and required immediate sphenoidal sinus packing. Emergent angiography revealed continued petrous carotid artery extravasation, warranting emergent vessel repair or deconstruction for treatment. To preserve the vessel, we utilized a covered Jostent. Due to tortuosity and lack of optimal wall apposition, there was reduced, yet persistent extravasation from an endoleak after Jostent deployment that failed to resolve despite multiple angioplasties. Therefore, we used PEDs to divert the flow. Flow diversion relieved the extravasation. The patient remained neurologically intact post-procedure. This case demonstrates successful combined use of a covered stent and flow diverters to treat acute vascular injury resulting from transsphenoidal surgery. However, concerns remain, including the requirement of dual antiplatelet agents increasing postoperative bleeding risks, stent-related thromboembolic events, and delayed in-stent restenosis rates.

A Double-Layered Covered Biliary Metal Stent for the Management of Unresectable Malignant Biliary Obstruction: A Multicenter Feasibility Study.

PubMed

Park, Jin-Seok; Jeong, Seok; Lee, Don Haeng; Moon, Jong Ho; Lee, Kyu Taek; Dong, Seok Ho

2016-11-15

The covered self-expandable metal stent (CMS) was developed to prevent tumor ingrowth-induced stent occlusion during the treatment of malignant biliary obstruction. However, complications such as cholecystitis, pancreatitis, and stent migration can occur after the endoscopic insertion of CMSs. The aim of the present study was to assess the efficacy and safety of a double-layered CMS (DCMS) for the management of malignant bile duct obstruction. DCMSs were endoscopically introduced into 59 patients with unresectable malignant extrahepatic biliary obstruction at four tertiary referral centers, and the patient medical records were retrospectively reviewed. Both the technical and functional success rates were 100%. Procedure-related complications including pancreatitis, cholangitis, stent migration, and liver abscess occurred in five patients (8.5%). The median follow-up period was 265 days (range, 31 to 752 days). Cumulative stent patency rates were 68.2% and 40.8% at 6 and 12 months, respectively. At the final follow-up, the rate of stent occlusion was 33.9% (20/59), and the median stent patency period was 276 days (range, 2 to 706 days). The clinical outcomes of DCMSs were comparable to the outcomes previously reported for CMSs with respect to stent patency period and complication rates.

Placement of a covered polyester stent prevents complications from a colorectal anastomotic leak and supports healing: randomized controlled trial in a large animal model.

PubMed

Tsereteli, Zurab; Sporn, Emanuel; Geiger, Timothy M; Cleveland, Dava; Frazier, Shellaine; Rawlings, Arthur; Bachman, Sharon L; Miedema, Brent W; Thaler, Klaus

2008-11-01

Anastomotic leaks after colorectal operation continue to be a significant cause of morbidity. A covered endoluminal stent could seal a leak and eliminate the need for diversion. The aim of this study was to test the efficacy of a temporary covered stent to prevent leak related complications. Sixteen adult pigs (80-120 lbs) underwent open transection of the rectosigmoid followed by anastomosis with a circular stapler. Eight animals (study group) underwent endoscopic placement of a 21-mm covered polyester stent. Eight control group animals were left without stents. In all animals, a 2-cm leak was created along the anterior portion of the anastomosis. The animals were killed after 2 weeks and evaluated for abdominal infection, fistulae, and adhesions. The anastomosis was excised and the following parameters were assessed by a pathologist blinded to treatment: mucosal interruption (mm), inflammatory response, collagen type I and III, granulation, and fibrosis (grade 0-4). Stents were spontaneously expelled between postoperative days 6 and 9. At necropsy, none of the animals in the study group had leak related complications, whereas in the control group, 5 (63%) developed intraabdominal infection (4 abscesses, 1 fistula) at the anastomosis (P = .002). Dense adhesions to the anastomosis were found in 7 (88%) control animals. On histology, anastomotic sites in the study group had significantly less mucosal interruption and granulation. Two pigs in the study group died on postoperative day 7, one due to evisceration and one from bladder necrosis. The mortality result is not different from controls (P = .47), both events seem to be unrelated to stent placement. Temporary placement of a covered polyester stent across a colorectal anastomosis prevents leak-related complications and supports the healing of anastomotic leaks.

Endovascular treatment of arterio-ureteral fistulae with covered stents: Case series and review of the literature

PubMed Central

Patel, Dhruv; Ranganath, Praveen; Contractor, Sohail

2014-01-01

Arterio-ureteral fistulae are abnormal connections between an artery and the ureter and carry a high mortality. We present two cases of arterio-ureteral fistulae that presented with life-threatening hematuria. Both patients were treated with endovascular covered stent placement. PMID:27489652

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

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

Crisostomo, Veronica; Song, Ho Young; Maynar, Manuel

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

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.

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.

Endoscopic suture fixation is associated with reduced migration of esophageal fully covered self-expandable metal stents (FCSEMS).

PubMed

Wright, Andrew; Chang, Andrew; Bedi, Aarti Oza; Wamsteker, Erik-Jan; Elta, Grace; Kwon, Richard S; Carrott, Phillip; Elmunzer, B Joseph; Law, Ryan

2017-09-01

Esophageal fully covered self-expandable metal stents (FCSEMS) are indicated for the management of benign and malignant conditions of the esophagus including perforations, leaks, and strictures. FCSEMS are resistant to tissue ingrowth and are removable; however, stent migration occurs in 30-55% of cases. Endoscopic suture fixation of FCSEMS has been utilized to decrease the risk of stent migration though data supporting this practice remain limited. The primary aim of this study was to compare clinical outcomes and migration rate of patients who underwent placement of esophageal FCSEMS with and without endoscopic suture fixation. Our single-center, retrospective, cohort study includes patients who underwent esophageal FCSEMS placement with and without endoscopic suture fixation between January 1, 2012, and November 11, 2015. Baseline patient characteristics, procedural details, and clinical outcomes were abstracted. Logistic regression was performed to identify clinical and technical factors associated with outcomes and stent migration. A total of 51 patients underwent 62 FCSEMS placements, including 21 procedures with endoscopic suture fixation and 41 without. Suture fixation was associated with reduced risk of stent migration (OR 0.13, 95% CI 0.03-0.47). Prior stent migration was associated with significantly higher risk of subsequent migration (OR 6.4, 95% CI 1.6-26.0). Stent migration was associated with lower likelihood of clinical success (OR 0.21, 95% CI 0.06-0.69). There was a trend toward higher clinical success among patients undergoing suture fixation (85.7 vs. 60.9%, p = 0.07). Endoscopic suture fixation of FCSEMS was associated with a reduced stent migration rate. Appropriate patient selection for suture fixation of FCSEMS may lead to reduced migration in high-risk patients.

Nitinol Esophageal Stents: New Designs and Clinical Indications

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

Strecker, Ernst-Peter; Boos, Irene; Vetter, Sylvia

1996-11-15

Purpose: To evaluate the clinical use of covered and noncovered, knitted nitinol stents in patients presenting new stent indications. Methods: Self-expandable, knitted nitinol stents were implanted in four patients for treatment of dysphagia. In two patients who had malignant strictures and had esophago-respiratory fistulae and in one patient with an esophagocutaneous fistula, polytetrafluoroethylene (PTFE)-covered stents were implanted. One patient received a noncovered stent, but a retrograde approach through a percutaneous endoscopic gastrostomy (PEG) fistula had to be chosen for recanalization of an esophageal occlusion. Two patients received stents for treatment of benign strictures. Results: Recanalization of the stricture and stentmore » implantation were performed under fluoroscopic control without any procedure-related morbidity or mortality. Dysphagia improved in all patients and the esophageal fistulae could be sealed off by covered stents. During a maximum follow-up of 18 months, there was no stent migration or esophageal perforation. Complications observed were stent stenosis due to food impaction (1/4) and benign stent stenosis (2/2). Most complications could be treated by the interventional radiologist. Conclusion: Self-expandable, covered Nitinol stents provide an option for the treatment of dysphagia combined with esophageal fistulae. In combination with interventional radiology techniques, even complex strictures are accessible. For benign strictures, the value of stent treatment has not yet been proven.« less

A Large Posttraumatic Subclavian Artery Aneurysm Complicated by Artery Occlusion and Arteriobronchial Fistula Successfully Treated Using a Covered Stent

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

Stefanczyk, Ludomir, E-mail: stefanczyk_l@wp.pl; Czeczotka, Jaroslaw; Elgalal, Marcin

2011-02-15

The treatment of posttraumatic aneurysms of peripheral arteries using covered stents is increasingly commonplace. We present the case of a 10-year-old girl with a pseudoaneurysm of the subclavian artery complicated by an arteriobronchial fistula with hemorrhaging into the bronchial tree and distal subclavian artery occlusion. Despite the lack of artery patency, endovascular stent graft implantation was successful. Pseudoaneurysm exclusion and involution was achieved, together with a patent implant and maintained collateral circulation patency.

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

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.

A US Multicenter Study of Safety and Efficacy of Fully Covered Self-Expandable Metallic Stents in Benign Extrahepatic Biliary Strictures.

PubMed

Saxena, Payal; Diehl, David L; Kumbhari, Vivek; Shieh, Frederick; Buscaglia, Jonathan M; Sze, Wilson; Kapoor, Sumit; Komanduri, Srinadh; Nasr, John; Shin, Eun Ji; Singh, Vikesh; Lennon, Anne Marie; Kalloo, Anthony N; Khashab, Mouen A

2015-11-01

Endoscopic therapy is considered first line for management of benign biliary strictures (BBSs). Placement of plastic stents has been effective but limited by their short-term patency and need for repeated procedures. Fully covered self-expandable metallic stents (FCSEMSs) offer longer-lasting biliary drainage without the need for frequent exchanges. The aim of this study was to assess the efficacy and safety of FCSEMS in patients with BBS. A retrospective review of all patients who underwent ERCP and FCSEMS placement at five tertiary referral US hospitals was performed. Stricture resolution and adverse events related to ERCP and/or stenting were recorded. A total of 123 patients underwent FCSEMS placement for BBS and 112 underwent a subsequent follow-up ERCP. The mean age was 62 years (±15.6), and 57% were males. Stricture resolution occurred in 81% of patients after a mean of 1.2 stenting procedures (mean stent dwell time 24.4 ± 2.3 weeks), with a mean follow-up of 18.5 months. Stricture recurrence occurred in 5 patients, and 3 patients required surgery for treatment of refractory strictures. Stent migration (9.7%) was the most common complication, followed by stent occlusion (4.9%), cholangitis (4.1%), and pancreatitis (3.3%). There was one case of stent fracture during removal, and one stent could not be removed. There was one death due to cholangitis. Majority of BBS can be successfully managed with 1-2 consecutive FCSEMS with stent dwell time of 6 months.

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

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.

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

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.

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.

Multicenter trial evaluating the use of covered self-expanding metal stents in benign biliary strictures: time to revisit our therapeutic options?

PubMed

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

2013-09-01

Covered self-expanding metal stents are being used more frequently in benign biliary strictures (BBS). We report the results of a multicenter study with fully covered self-expanding metal stent (FCSEMS) placement for the management of BBS. : To prospectively evaluate the efficacy and safety of FCSEMS in the management of BBS. Patients with BBS from 6 tertiary care centers who received FCSEMS with flared ends between April 2009 and October 2010 were included in this retrospective study.Efficacy was measured after removal of FCSEMS by evaluating stricture resolution on the basis of symptom resolution, imaging, laboratory studies, and/or choledochoscopy at removal. Safety profile was evaluated by assessing postprocedural complications. A total of 133 patients (78, 58.6% males) with a mean age of 59.2±14.8 years with BBS received stents. Of the 133 stents placed, 97 (72.9%) were removed after a mean stent duration of 95.5±48.7 days. Stricture resolution after FCSEMS removal was as follows: postsurgical, 11/12 (91.6%); gallstone-related disease, 16/19 (84.2%); chronic pancreatitis, 26/31 (80.7%); other etiology, 4/5 (80.0%); and anastomotic strictures, 19/31(61.2%). Ninety-four patients were included in the logistic regression analyses. Patients who had indwelling stents for >90 days were 4.3 times more likely to have resolved strictures [odds ratio, 4.3 (95% confidence interval, 1.24-15.09)] and patients with nonmigrated stents were 5.4 times more likely to have resolved strictures [odds ratio, 5.4 (95% confidence interval, 1.001-29.29)]. FCSEMS for BBS had an acceptable rate of stricture resolution for postsurgical strictures, gallstone-related strictures, and those due to chronic pancreatitis. Predictors for stricture resolution include longer indwell time and absence of migration. Further study is warranted to assess long-term efficacy in a prospective manner with longer than 3-month time of stent indwelling time.

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

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.

SEMS vs cSEMS in duodenal and small bowel obstruction: High risk of migration in the covered stent group

PubMed Central

Waidmann, Oliver; Trojan, Jörg; Friedrich-Rust, Mireen; Sarrazin, Christoph; Bechstein, Wolf Otto; Ulrich, Frank; Zeuzem, Stefan; Albert, Jörg Gerhard

2013-01-01

AIM: To compare clinical success and complications of uncovered self-expanding metal stents (SEMS) vs covered SEMS (cSEMS) in obstruction of the small bowel. METHODS: Technical success, complications and outcome of endoscopic SEMS or cSEMS placement in tumor related obstruction of the duodenum or jejunum were retrospectively assessed. The primary end points were rates of stent migration and overgrowth. Secondary end points were the effect of concomitant biliary drainage on migration rate and overall survival. The data was analyzed according to the Strengthening the Reporting of Observational Studies in Epidemiology guidelines. RESULTS: Thirty-two SEMS were implanted in 20 patients. In all patients, endoscopic stent implantation was successful. Stent migration was observed in 9 of 16 cSEMS (56%) in comparison to 0/16 SEMS (0%) implantations (P = 0.002). Stent overgrowth did not significantly differ between the two stent types (SEMS: 3/16, 19%; cSEMS: 2/16, 13%). One cSEMS dislodged and had to be recovered from the jejunum by way of laparotomy. Time until migration between SEMS and cSEMS in patients with and without concomitant biliary stents did not significantly differ (HR = 1.530, 95%CI 0.731-6.306; P = 0.556). The mean follow-up was 57 ± 71 d (range: 1-275 d). CONCLUSION: SEMS and cSEMS placement is safe in small bowel tumor obstruction. However, cSEMS is accompanied with a high rate of migration in comparison to uncovered SEMS. PMID:24115817

Endovascular management of radiotherapy-induced injury to brachiocephalic artery using covered stents.

PubMed

Cenizo, Noelia Maria; Gonzalez-Fajardo, Jose A; Ibanez, Maria A; Gastambide, Victoria; Martin-Pedrosa, Miguel; Gutierrez, Vicente; Taylor, James; Vaquero, Carlos

2014-04-01

Actinic vascular lesions tend to be stenotic-occlusive lesions. In this article, we present 2 exceptional cases of pseudoaneurysms caused by radionecrosis of the supra-aortic trunks. Both patients were treated by a retrograde carotid approach and deployment of a self-expanding covered stent. Proper exclusion of the pseudoaneurysm was attained in both cases; the first patient remained asymptomatic 12 months later; the second patient died of mediastinitis. Compared with conventional surgery, endovascular management is a viable, less invasive alternative in select patients, especially in life-threatening cases. Copyright © 2014 Elsevier Inc. All rights reserved.

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.

Lumen-apposing covered self-expandable metal stents for short benign gastrointestinal strictures: a multicenter study.

PubMed

Yang, Dennis; Nieto, Jose M; Siddiqui, Ali; Riff, Brian P; DiMaio, Christopher J; Nagula, Satish; Ismail, Amr M; Ngamreungphong, Saowanee; Khashab, Mouen A; Wagh, Mihir S; Tzimas, Demetrios; Buscaglia, Jonathan M; Strand, Daniel S; Wang, Andrew Y; Chauhan, Shailendra S; Forsmark, Christopher E; Draganov, Peter V

2017-04-01

Background and study aim  Use of the fully covered self-expandable metal stent (SEMS) for benign luminal gastrointestinal (GI) stricture (BLGS) has been limited by the migration rate. The role of the lumen-apposing metal stent (LAMS) for BLGS is not well defined. We assessed the safety, feasibility, and efficacy of LAMS for the treatment of BLGS. Patients and methods  This was an observational, open-label, retrospective, single-arm, multicenter consecutive case series of patients undergoing LAMS placement for BLGS. Technical success was defined as successful placement of the LAMS. Short- and long-term clinical success rates were defined as symptom improvement/resolution with indwelling stent and after stent removal, respectively. All adverse events and additional interventions were recorded. Results  A total of 30 patients (mean age 51.6 years; 63.3 % women) underwent LAMS placement for GI strictures (83.9 % anastomotic). Median stricture diameter and length were 4.5 mm (range 2 - 10 mm) and 8 mm (range 5 - 10 mm), respectively. Technical success was achieved in 29 patients (96.7 %), with an adverse event rate of 13.3 %. The stent migration rate was 8.0 % (2/25) on follow-up endoscopy. Short-term clinical success was achieved in 90.0 % (27/30) at a median of 60 days (interquartile range [IQR] 40 - 90 days). Most patients (19/23; 82.6 %) experienced sustained symptom improvement/resolution without the need for additional interventions at a median follow-up of 100 days (IQR 60 - 139 days) after LAMS removal. Conclusion  This multicenter study demonstrated that LAMS placement represents a safe, feasible, and effective therapeutic option for patients with BLGS and is associated with a low stent migration rate. Our initial findings suggest that future prospective comparative studies are needed on the use of LAMS, endoscopic dilation, and conventional SEMS. . © Georg Thieme Verlag KG Stuttgart · New York.

Treatment of a coronary artery aneurysm by use of a covered stent graft – a case report

PubMed Central

Gundoğdu, Fuat; Arslan, Sakir; Buyukkaya, Eyup; Senocak, Huseyin

2007-01-01

Coronary artery aneurysm is a rare finding at coronary angiography. Most coronary aneurysms remain asymptomatic. There is no consensus on its management; some advocate aggressive approach while others advocate conservative management. A case of coronary artery aneurysm successfully treated by implantation of a polytetrafluoroethylene-covered coronary stent is presented. PMID:22477247

Anatomic bifurcated reconstruction of chronic bilateral innominate-superior vena cava occlusion using the Y-stenting technique.

PubMed

Amin, Parth; Sharafuddin, Mel J; Laurich, Chad; Nicholson, Rachael M; Sun, Raphael C; Roh, Simon; Kresowik, Timothy F; Sharp, William J

2012-02-01

This article presents the case of a 42-year-old man who presented with superior vena cava (SVC) syndrome due to fibrosing mediastinitis with multiple failed attempts at recanalization. We initially treated him with unilateral sharp needle recanalization of the right innominate vein into the SVC stump followed by stenting. Although his symptoms improved immediately, they did not completely resolve. Six months later, he returned with worsening symptoms, and venography revealed in-stent restenosis. The patient requested simultaneous treatment on the left side. The right stent was dilated, and a 3-cm-long occlusion of the left innominate vein was recanalized, again using sharp needle technique, homing into the struts of the right-sided stent. Following fenestration of the stent, a second stent was deployed from the left side into the SVC, and the two Y limbs were sequentially dilated to allow a true bifurcation anatomy (figure). The patient had complete resolution of his symptoms and continues to do well 6 months later. Copyright © 2012 Annals of Vascular Surgery Inc. Published by Elsevier Inc. All rights reserved.

Feasibility of placing a modified fully covered self-expandable metal stent above the papilla to minimize stent-induced bile duct injury in patients with refractory benign biliary strictures (with videos).

PubMed

Moon, Jong Ho; Choi, Hyun Jong; Koo, Hyun Cheol; Han, Seung Hyo; Lee, Tae Hoon; Cho, Young Deok; Park, Sang-Heum; Kim, Sun-Joo

2012-05-01

Endoscopic placement of fully covered self-expandable metal stents (FCSEMS) has been attempted to manage benign biliary strictures, but currently available FCSEMSs may be associated with unintended complications, including de novo strictures, in patients with normal life expectancy. To evaluate the feasibility of an intraductally placed modified FCSEMS to minimize stent-induced bile duct injury in patients with benign biliary strictures. Prospective observational clinical feasibility study. Tertiary-care academic center. This study involved 21 patients with symptomatic benign biliary strictures in whom conventional endoscopic management failed. Strictured segments were 15 mm above the ampulla of Vater. The modified FCSEMS has convex margins, a lasso, and an anti-migrating waist on the central portion. Stents were placed entirely above the papilla and removed after 3 to 5 months. Success, complications, removability, midterm outcome. FCSEMSs were successfully placed inside the bile duct in all patients. No episodes of pancreatitis, cholangitis, or sepsis were noted during the stenting period. Stent migration occurred in 4 patients (19.0%), but 3 were asymptomatic during follow-up. All stents were removed successfully with rat-tooth forceps without complications. Post-stenting cholangiograms showed improvement of strictures in 20 of 21 patients, without de novo focal stricture. The clinical success rate was 95.2%, with one recurrent stricture. The small number and lack of comparison with other types of FCSEMSs. Temporary intraductal placement of a newly modified FCSEMS effectively improved strictures and prevented potential stent-induced complications in patients with benign biliary strictures. Controlled large-scale trials are needed to confirm the long-term efficacy. Copyright © 2012 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

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

Our Experience on Silicone Y-Stent for Severe COPD Complicated With Expiratory Central Airway Collapse.

PubMed

Ozgul, Mehmet A; Cetinkaya, Erdogan; Cortuk, Mustafa; Iliaz, Sinem; Tanriverdi, Elif; Gul, Sule; Ozgul, Guler; Onaran, Hilal; Abbasli, Kenan; Dincer, Huseyin E

2017-04-01

Expiratory central airway collapse (ECAC) is abnormal central airway narrowing during expiration. ECAC involves 2 different pathophysiological entities as tracheobronchomalacia and excessive dynamic airway collapse (EDAC). Although the exact cause is unknown, chronic obstructive pulmonary disease (COPD) is frequently accompanied by ECAC. Although there are various publications on the relationship between COPD and ECAC, there are very few data for stent placement in patients with tracheobronchomalacia accompanied severe COPD. We share our results for stenting in ECAC among patients with severe COPD. The data in this case series were collected retrospectively. The ECAC diagnosis was made during flexible bronchoscopy with severe COPD. Silicone Y-stents were placed via rigid bronchoscopy under general anesthesia. A total of 9 patients' (7 men) data were evaluated with an average age of 67±10.73 years. One patient experienced stent migration on the second day of stenting prompting stent removal. Another patient died 1 month after stenting. Consequently, we evaluated the follow-up data of remaining 7 patients. The changes in forced expiratory volume 1 was not significant for these 7 cases (P=0.51). The modified Medical Research Council (mMRC) score improvement was statistically significant (P=0.03). Functional status improvement was observed in 4 of 7 patients. Of the 7 patients, mean additional follow-up bronchoscopic interventions requirement was 2.2 times. Our study showed significant decrease in mMRC score with stenting for ECAC in severe COPD. For 2 patients, we experienced severe complications during short-term follow-up period after stenting. Additional follow-up bronchoscopic interventions were required.

Mechanical behavior of peripheral stents and stent-vessel interaction: A computational study

NASA Astrophysics Data System (ADS)

Dottori, Serena; Flamini, Vittoria; Vairo, Giuseppe

2016-05-01

In this paper stents employed to treat peripheral artery disease are analyzed through a three-dimensional finite-element approach, based on a large-strain and large-displacement formulation. Aiming to evaluate the influence of some stent design parameters on stent mechanics and on the biomechanical interaction between stent and arterial wall, quasi-static and dynamic numerical analyses are carried out by referring to computational models of commercially and noncommercially available versions of both braided self-expandable stents and balloon-expandable stents. Addressing isolated device models, opening mechanisms and flexibility of both opened and closed stent configurations are numerically experienced. Moreover, stent deployment into a stenotic peripheral artery and possible postdilatation angioplasty (the latter for the self-expandable device only) are simulated by considering different idealized vessel geometries and accounting for the presence of a stenotic plaque. Proposed results highlight important differences in the mechanical response of the two types of stents, as well as a significant influence of the vessel shape on the stress distributions arising upon the artery-plaque system. Finally, computational results are used to assess both the stent mechanical performance and the effectiveness of the stenting treatment, allowing also to identify possible critical conditions affecting the risk of stent fracture, tissue damage, and/or pathological tissue response.

[A new generation of urethral stents--Allium in the therapy of symptomatic prostatic enlargement of various etiology].

PubMed

Marković, B B; Marković, Z; Yachia, D; Hadzi, Djokić J

2007-01-01

A number of urethral stents made of different materials, with different time of indwelling and different designs, primarily based on the vascular stent concept, have been applied in the clinical practice so far. According to the published studies, urethral stents have justified their clinical application, however with certain limitations. Within an attempt to overcome the limitations, a covered, temporary urethral stent was initially designed by Daniel Yachie and Ijko Markovi in Allium corporation from Israel. With its triangular shape, the stent is a replica of the obstructive prostatic urethral lumen. In has been applied in a series of 14 patients with lower urinary tract symptoms caused by the obstruction at the level of the prostatic urethra. The subjects were averagely aged 77.4 +/- 5.1 years. Allium prostatic stent remained in place in the patients for 4.93 +/- 3.17 months, at the average.

A fully covered self-expandable metal stent with antimigration features for benign biliary strictures: a prospective, multicenter cohort study.

PubMed

Walter, Daisy; Laleman, Wim; Jansen, Jeroen M; van Milligen de Wit, A W M; Weusten, Bas L; van Boeckel, Petra G; Hirdes, Meike M; Vleggaar, Frank P; Siersema, Peter D

2015-05-01

Self-expandable metal stents (SEMSs) are increasingly used for the treatment of benign biliary strictures (BBSs). A new fully covered SEMS (FCSEMS) with flared ends and high conformability was designed to prevent migration of the stent. To evaluate the efficacy of a novel FCSEMS with antimigration features. Prospective cohort study. Five hospitals in the Netherlands and Belgium. Consecutive patients with BBS. FCSEMS placement for 3 months. Initial and long term clinical success, stent migration rate and safety. Thirty-eight patients (24 men; mean age, 53 ± 16 years) were included. Stent placement was technically successful in 37 patients (97%). Two patients died of an unrelated cause before stent removal, and no data on these patients were available on stricture resolution. Initial clinical success was achieved in 28 of 35 patients (80%). During follow-up after stent removal, a symptomatic recurrent stricture developed in 6 of 28 patients (21%). Overall, the long-term clinical success rate was 63% (22 of 35 patients). Stent migration occurred in 11 of 35 patients (31%), including 5 symptomatic (14%) and 6 asymptomatic (17%) migrations. In total, 11 serious adverse events occurred in 10 patients (29%), with cholangitis (n = 5) being most common. Nonrandomized study design. Good initial clinical success was achieved after placement of this novel FCSEMS, but stricture recurrence was in the upper range compared with other FCSEMSs. The antimigration design could not prevent migration in a significant number of patients with a persisting stricture. Copyright © 2015 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

Clinical outcome of endoscopic covered metal stenting for resolution of benign biliary stricture: Systematic review and meta-analysis.

PubMed

Zheng, Xiao; Wu, Jun; Sun, Bo; Wu, Ye-Chen; Bo, Zhi-Yuan; Wan, Wei; Gao, Dao-Jian; Hu, Bing

2017-03-01

Management of benign biliary stricture is challenging. Endoscopic therapy has evolved as the first-line treatment for various benign biliary strictures. However, covered self-expandable metal stents (CSEMS) have not been approved by the United States Food and Drug Administration for the treatment of benign biliary stricture. With this goal, we conducted the present systemic review and meta-analysis to evaluate the efficacy and safety of endoscopic stenting with CSEMS in the treatment of benign biliary stricture. Systematic review and meta-analysis by searching PubMed, MEDLINE and Embase databases. In total, 37 studies (1677 patients) fulfilled the inclusion criteria. Pooled stricture resolutions were achieved in 83% of cases. Median stent dwelling time was 4.4 months, with median endoscopic retrograde cholangiopancreatography sessions of 2.0. Stricture recurrence at 4-year follow up was 11% (95% CI, 8-14%). Pooled complication rate was 23% (95% CI, 20-26%). Placement of CSEMS is effective in the treatment of benign biliary stricture with relatively short stenting duration and low long-term stricture recurrence rate. However, more prospectively randomized studies are required to confirm the results. © 2016 Japan Gastroenterological Endoscopy Society.

New dedicated bifurcated silicone stent placement for stenosis around the primary right carina.

PubMed

Oki, Masahide; Saka, Hideo

2013-08-01

Silicone stenting has been widely used to palliate respiratory symptoms in patients suffering from airway stenosis. Although many types and shapes of stents have been developed, there is no ideal stent for stenosis around the carina between the bronchus to the right upper lobe and the bronchus intermedius (primary right carina). The purpose of this study was to evaluate the feasibility, efficacy, and safety of a new silicone stent designed for treating airway stenosis around the primary right carina. We recruited 16 patients with suspected stenosis around the primary right carina. Ten of the patients met the inclusion criteria for inserting the study stent. All stenting procedures were performed with a rigid and flexible bronchoscope under general anesthesia. The study stent could be mounted successfully on the primary right carina in all 10 patients. Five patients underwent stenting using only the new stent, and the other five underwent stenting with it on the primary right carina and a silicone Y stent on the main carina. The dyspnea index improved in eight of the 10 patients, including one who was mechanically ventilated. Early complications developed in three patients (temporary pneumonia in two and retention of secretions in one), and late complications occurred in two patients (granuloma formation in one and hemoptysis in one). Stent placement with the new silicone stent designed to fit on the primary right carina is feasible, effective, and acceptably safe. UMIN-Clinical Trials Registry; No.: UMIN000001776; URL: www.umin.ac.jp/ctr.

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.

Evaluation of biodegradable paclitaxel-eluting nanofibre-covered metal stents for the treatment of benign cardia stricture in an experimental model.

PubMed

Zhu, Y-Q; Cui, W-G; Cheng, Y-S; Chang, J; Chen, N-W; Yan, L

2013-05-01

Benign strictures at the cardia are troublesome for patients and often require repeated endoscopic treatments. Paclitaxel can reduce fibrosis. This study evaluated a biodegradable paclitaxel-eluting nanofibre-covered metal stent for the treatment of benign cardia stricture in vitro and in vivo. Drug release was investigated in vitro at pH 7·4 and 4·0. Eighty dogs were divided randomly into four groups (each n = 20): controls (no stent), bare stent (retained for 1 week), and two drug-eluting stent (DES) groups with retention for either 1 week (DES-1w) or 4 weeks (DES-4w). Lower oesophageal sphincter pressure (LOSP) and 5-min barium height (5-mBH) were assessed before, immediately after stent deployment, at 1 week, and 1, 3 and 6 months later. Five dogs in each group were killed for histological examination at each follow-up point. Stent migration rates were similar (0 bare stent versus 2 DES; P = 0·548). The percentage and amount of paclitaxel released in vitro was higher at pH 4·0 than at pH 7·4. After 6 months, LOSP and 5-mBH were both improved in the DES-1w (P = 0·004 and P = 0·049) and DES-4w (both P < 0·001) groups compared with the bare-stent group, with better relief when the stent was retained for 4 weeks (P = 0·004 and P = 0·007). The DES was associated with a reduced peak inflammatory reaction and less scar formation compared with bare stents, especially when inserted for 4 weeks. The DES was more effective for the treatment of benign cardia stricture than bare stents in a canine model. Retention of the DES for 4 weeks led to a better clinical and pathological outcome than 1 week. © 2013 British Journal of Surgery Society Ltd. Published by John Wiley & Sons Ltd.

A new technique of deploying dynamic y stent using flexible bronchoscope, video laryngoscope, and laryngeal mask airway.

PubMed

Obeidat, Shadi; Badin, Shadi; Khawaja, Imran

2010-04-01

Dynamic Y stents are used in tracheobronchial obstruction, tracheal stenosis, and tracheomalacia. Placement may be difficult and is usually accomplished using a rigid grasping forceps (under fluoroscopic guidance) or a rigid bronchoscope. We report using a new stent placement technique on an elderly patient with a central tracheobronchial tumor. It included using a flexible bronchoscope, video laryngoscope, and laryngeal mask airway. The new technique we used has the advantages of continuous direct endoscopic visualization during stent advancement and manipulation, and securing the airways with a laryngeal mask airway at the same time. This technique eliminates the need for intraoperative fluoroscopy.

Management of pancreatic collections with a novel endoscopically placed fully covered self-expandable metal stent: a national experience (with videos).

PubMed

Chandran, Sujievvan; Efthymiou, Marios; Kaffes, Arthur; Chen, John Wei; Kwan, Vu; Murray, Michael; Williams, David; Nguyen, Nam Quoc; Tam, William; Welch, Christine; Chong, Andre; Gupta, Saurabh; Devereaux, Ben; Tagkalidis, Peter; Parker, Frank; Vaughan, Rhys

2015-01-01

Recent medical literature on novel lumen-apposing stents for the treatment of pancreatic fluid collections (PFCs) is limited by small numbers, solo operators, and single-center experience. To evaluate a recently developed lumen-apposing, fully covered self-expandable metal stent (FCSEMS) in the management of PFCs. Retrospective case series. Thirteen tertiary and private health care centers across Australia. Forty-seven patients (median age 51 years) who underwent endoscopic management of PFCs. Insertion of FCSEMS after PFC puncture under EUS guidance. A subgroup of 9 patients underwent direct endoscopic necrosectomy. Technical and clinical success rate, adverse event rate. The technical success rate was 53 of 54 patients (98.1%), and the initial clinical success rate was 36 of 47 (76.6%), which was sustained for more than 6 months in 34 of 36 (94.4%). Early adverse events included 4 cases (7.4%) of stent migration during direct endoscopic necrosectomy, 4 cases (7.4%) of sepsis, 1 case (1.9%) of bleeding, and 1 case (1.9%) of stent migration into the fistula tract. Late adverse events were 6 (11.1%) spontaneous stent migrations, 3 (5.6%) recurrent stent occlusions, 3 (5.6%) tissue ingrowth/overgrowth, and 2 (3.7%) bleeding into PFC. The majority of stents inserted (48 of 54, 88.9%) and removed (31 of 35, 88.6%) in our study were described by the operator as superior to pigtail stents with regard to ease of use. Retrospective study. Although FCSEMSs are technically easier to insert and remove compared with traditional pigtail stents, there are significant limitations to the widespread use of FCSEMSs in the management of PFCs. These include cost, adverse events, and lower-than-expected resolution rates. Copyright © 2015 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

Allium Stents: A Novel Solution for the Management of Upper and Lower Urinary Tract Strictures.

PubMed

Bahouth, Zaher; Moskovitz, Boaz; Halachmi, Sarel; Nativ, Ofer

2017-10-16

Stents are widely use in endoscopic urological procedures. One of the most important indications is the treatment of urinary tract strictures. Allium™ Medical has introduced several types of stents for the treatment of different types of urinary tract strictures, based on anatomic location. All the stents are made of nitinol and coated with a co-polymer that reduces encrustations. These stents are self-expandable and have a large caliber and a high radial force. They have different shapes, designed especially for the treatment of each type of stricture. One of the most important features of Allium-manufactured stents is the ease of removal, due to their special unraveling feature. The company has introduced the Bulbar Urethral Stent (BUS) for treatment of bulbar urethral strictures; a rounded stent available in different lengths. Initial data on 64 patients with bulbar urethral stricture treated with the BUS showed a significant improvement in symptoms, with minimal complications and few adverse events. For treatment of prostate obstruction in patients unfit for surgery or unwilling to undergo a classical prostatic surgery, the Triangular Prostatic Stent (TPS) was introduced, which has a triangular shape that fits in the prostatic urethra. Its body has a high radial force attached to an anchor (which prevents migration) through a trans-sphincteric wire (which reduces incontinence rate). Initial data on 51 patients showed significant improvement in symptoms and in urinary peak flow rate, with a relatively small number of complications. The Round Posterior Stent (RPS) was designed for treatment of post radical prostatectomy bladder neck contracture. This short, round stent has an anchor, which is placed in the bladder neck. This stent being relatively new, the clinical data are still limited. Ureteral strictures can be treated with the Ureteral Stent (URS), which is round-shaped, available in different lengths, and has an anchor option (for very distal or very

Future developments in biliary stenting

PubMed Central

Hair, Clark D; Sejpal, Divyesh V

2013-01-01

Biliary stenting has evolved dramatically over the past 30 years. Advancements in stent design have led to prolonged patency and improved efficacy. However, biliary stenting is still affected by occlusion, migration, anatomical difficulties, and the need for repeat procedures. Multiple novel plastic biliary stent designs have recently been introduced with the primary goals of reduced migration and improved ease of placement. Self-expandable bioabsorbable stents are currently being investigated in animal models. Although not US Food and Drug Administration approved for benign disease, fully covered self-expandable metal stents are increasingly being used in a variety of benign biliary conditions. In malignant disease, developments are being made to improve ease of placement and stent patency for both hilar and distal biliary strictures. The purpose of this review is to describe recent developments and future directions of biliary stenting. PMID:23837001

Self-Expandable Metal Stents and Trans-stent Light Delivery: Are Metal Stents and Photodynamic Therapy Compatible?

PubMed Central

Wang, Luo-Wei; Li, Li-Bo; Li, Zhao-Shen; Chen, Yang K; Hetzel, Fred W.; Huang, Zheng

2008-01-01

Background and Objectives: Obstructive non-small cell lung cancer and obstructive esophageal cancer are US FDA approved indications of photodynamic therapy (PDT). The usefulness of PDT for the treatment of cholangiocarcinoma is currently under clinical investigation. Endoscopic stenting for lumen restoration is a common palliative intervention for those indications. It is important to assess whether self-expandable metal stents are compatible with trans-stent PDT light delivery. Study Design/Materials and Methods: Direct effects of various components of metal biliary (n = 2), esophageal (n = 2), and bronchial (n = 1) stents on PDT light transmittance and distribution were examined using a point or linear light source (630 or 652 nm diode laser). Resected pig biliary duct and esophageal wall tissues were used to examine the feasibility of PDT light delivery through the fully expanded metal stents. Results: While using a point light source, the metal components (thread and joint) of the stent could cause a significant shadow effect. The liner material (polytetrafluoroethylene or polyurethane) could cause various degrees of light absorption. When the stent was covered with a thin layer of biliary duct and esophageal tissues containing all wall layers, the shadow effect could be mitigated due to tissue scattering. Conclusions: This study clearly demonstrates that it is feasible to combine stenting and PDT for the treatment of luminal lesions. PDT light dose should be adjusted to counteract the reduction of light transmittance caused by the metal and liner materials of stent. PMID:18951422

Evaluation on Compressive Characteristics of Medical Stents Applied by Mesh Structures

NASA Astrophysics Data System (ADS)

Hirayama, Kazuki; He, Jianmei

2017-11-01

There are concerns about strength reduction and fatigue fracture due to stress concentration in currently used medical stents. To address these problems, meshed stents applied by mesh structures were interested for achieving long life and high strength perfromance of medical stents. The purpose of this study is to design basic mesh shapes to obatin three dimensional (3D) meshed stent models for mechanical property evaluation. The influence of introduced design variables on compressive characteristics of meshed stent models are evaluated through finite element analysis using ANSYS Workbench code. From the analytical results, the compressive stiffness are changed periodically with compressive directions, average results need to be introduced as the mean value of compressive stiffness of meshed stents. Secondly, compressive flexibility of meshed stents can be improved by increasing the angle proportional to the arm length of the mesh basic shape. By increasing the number of basic mesh shapes arranged in stent’s circumferential direction, compressive rigidity of meshed stent tends to be increased. Finaly reducing the mesh line width is found effective to improve compressive flexibility of meshed stents.

A New Fully Covered Self-Expandable Metal Stent for the Treatment of Postsurgical Benign Biliary Strictures.

PubMed

Wu, Jun; Zhou, Dong-Xun; Wang, Tian-Tian; Gao, Dao-Jian; Hu, Bing

2017-09-01

Endotherapy with plastic stent (PS) placement is the main modality for treating benign biliary strictures (BBSs). Fully covered self-expandable metal stents (FCSEMSs) are being increasingly used for BBS management, with high stricture resolution. However, traditional metal tents are associated with high migration, causing treatment failure. We investigated the efficacy and safety of a new FCSEMS for postsurgical BBS treatment and compared these parameters between the FCSEMS and PS treatment through retrospective analysis. The primary outcome measurements included stricture resolution, stricture recurrence, and complications. In total, 69 patients were included, of whom 32 underwent FCSEMS treatment and 37 underwent PS treatment. The technical success rate and the number of endoscopic retrograde cholangiopancreatography procedures were similar between the groups. The median stenting duration was 5.2 months (range 1.5-15.3) in the FCSEMS group and 10.7 months (range 2.5-22.6) in the PS group (P < 0.01). The stents removal rate was 96.9% in the FCSEMS group and 94.6% in the PS group. The stricture resolution rate based on intention-to-treat analysis was 83.8% in the PS group and 84.4% (27/32) in the FCSEMS group (P = 0.947), whereas the rates from per-protocol analysis were 88.6% (31/35) and 87.1% (27/31), respectively (P = 0.574). Early and late complications were similar between the groups. The median follow-up time was 43 months (range 13-71). The stricture recurrence rate was 11.1% (3/27) in the FCSEMS group and 16.1% (5/31) in the PS group (P = 0.435). The new FCSEMS and the PS approach showed similar efficacy and safety in postsurgical BBS treatment. However, the FCSEMS required fewer procedural steps and shorter stenting time, making it an effective alternative modality.

Management of postoperative esophageal leaks with the Polyflex self-expanding covered plastic stent.

PubMed

Langer, Felix B; Wenzl, Etienne; Prager, Gerhard; Salat, Andreas; Miholic, Johannes; Mang, Thomas; Zacherl, Johannes

2005-02-01

Esophageal anastomotic leaks can lead to prolonged hospitalization. In this article we present our experience with the placement of the Polyflex self-expanding plastic stent (Willy Ruesch GMBH, Kernen, Germany) for leak occlusion. Between April 2000 and November 2003, 24 patients were included into this prospective study and underwent Polyflex stent placement for postoperative esophageal anastomotic leaks. The primary operation was esophagectomy in 13 patients, gastrectomy in 7, cardia resection in 2, and other procedures in 2 patients. The median interval between operation and stent placement was 19 days (range, 4 to 65). The effectiveness of leak occlusion was evaluated by water-soluble contrast swallow and the clinical course. In 2 patients stent misplacement produced an enlarged anastomotic dehiscence that necessitated reoperation. Radiologic evaluation was impossible in 4 patients because of their generally restricted condition. Among 18 evaluable patients, leak occlusion was successful with a single stent in 16 patients (89%) based on radiologic evaluation. Immediate oral feeding was well tolerated by these patients. After a median follow-up of 220 days (range, 7 to 1221), 9 cases of late stent dislocation were observed. Stent removal in patients after esophagectomy with gastric pull-up led to dysphagia from anastomotic strictures in 2 patients. Symptomatic strictures did not develop in the 5 evaluable postgastrectomy patients after stent removal. The placement of self-expanding plastic stents is a highly effective treatment for esophageal anastomotic leaks. Because clinically-relevant anastomotic strictures can be expected, we do not recommend stent removal after esophagectomy with gastric pull-up reconstruction.

An in vivo pilot study of a microporous thin film nitinol-covered stent to assess the effect of porosity and pore geometry on device interaction with the vessel wall.

PubMed

Chun, Youngjae; Kealey, Colin P; Levi, Daniel S; Rigberg, David A; Chen, Yanfei; Tillman, Bryan W; Mohanchandra, K P; Shayan, Mahdis; Carman, Gregory P

2017-03-01

Sputter-deposited thin film nitinol constructs with various micropatterns were fabricated to evaluate their effect on the vessel wall in vivo when used as a covering for commercially available stents. Thin film nitinol constructs were used to cover stents and deployed in non-diseased swine arteries. Swine were sacrificed after approximately four weeks and the thin film nitinol-covered stents were removed for histopathologic evaluation. Histopathology revealed differences in neointimal thickness that correlated with the thin film nitinol micropattern. Devices covered with thin film nitinol with a lateral × vertical length = 20 × 40 µm diamond pattern had minimal neointimal growth with well-organized cell architecture and little evidence of ongoing inflammation. Devices covered with thin film nitinol with smaller fenestrations exhibited a relatively thick neointimal layer with inflammation and larger fenestrations showed migration of inflammatory and smooth muscle cells through the micro fenestrations. This "proof-of-concept" study suggests that there may be an ideal thin film nitinol porosity and pore geometry to encourage endothelialization and incorporation of the device into the vessel wall. Future work will be needed to determine the optimal pore size and geometry to minimize neointimal proliferation and in-stent stenosis.

Incidence and Clinical Features of Early Stent Thrombosis in the Era of New P2y12 Inhibitors (PLATIS-2)

PubMed Central

Asher, Elad; Abu-Much, Arsalan; Goldenberg, Ilan; Segev, Amit; Sabbag, Avi; Mazin, Israel; Shlezinger, Meital; Atar, Shaul; Zahger, Doron; Polak, Arthur; Beigel, Roy; Matetzky, Shlomi

2016-01-01

Early stent thrombosis (EST) (≤ 30 days after stent implantation) is a relatively rare but deleterious complication of percutaneous coronary intervention (PCI). Administration of newer P2Y12 inhibitors (prasugrel and ticagrelor) combined with aspirin has been shown to reduce the incidence of sub-acute and late stent thrombosis, compared with clopidogrel. We investigated the “real life” incidence of EST in patients from a large acute coronary syndrome (ACS) national registry, where newer P2Y12 inhibitors are widely used. Patients were derived from the ACS Israeli Survey (ACSIS), conducted during 2006, 2008, 2010 and 2013. Major adverse cardiac events (MACE) at 30days were defined as all-cause death, recurrent ACS, EST and stroke.Of the 4717 ACS patients who underwent PCI and stenting, 83% received clopidogrel and 17% newer P2Y12 inhibitors. The rate of EST was similar in both groups (1.7% in the newer P2Y12 inhibitor group vs. 1.4% in the clopidogrel-treated patients, p = 0.42). Results were consistent after multivariate analysis (adjusted HR = 1.06 [p = 0.89]). MACE occurred in 6.4% in the newer P2Y12 inhibitor group compared with 9.2% in the clopidogrel group (P<0.01). However, multivariate logistic regression modeling showed that treatment with newer P2Y12 inhibitors was not significantly associated with the secondary endpoint of MACE when compared with clopidogrel therapy [OR = 1.26 95%CI (0.93–1.73), P = 0.136]. The incidence of "real life" EST at 1month is relatively low, and appears to be similar in patients who receive newer P2Y12 inhibitors as well as in those who receive clopidogrel. PMID:27310147

Incidence and Clinical Features of Early Stent Thrombosis in the Era of New P2y12 Inhibitors (PLATIS-2).

PubMed

Asher, Elad; Abu-Much, Arsalan; Goldenberg, Ilan; Segev, Amit; Sabbag, Avi; Mazin, Israel; Shlezinger, Meital; Atar, Shaul; Zahger, Doron; Polak, Arthur; Beigel, Roy; Matetzky, Shlomi

2016-01-01

Early stent thrombosis (EST) (≤ 30 days after stent implantation) is a relatively rare but deleterious complication of percutaneous coronary intervention (PCI). Administration of newer P2Y12 inhibitors (prasugrel and ticagrelor) combined with aspirin has been shown to reduce the incidence of sub-acute and late stent thrombosis, compared with clopidogrel. We investigated the "real life" incidence of EST in patients from a large acute coronary syndrome (ACS) national registry, where newer P2Y12 inhibitors are widely used. Patients were derived from the ACS Israeli Survey (ACSIS), conducted during 2006, 2008, 2010 and 2013. Major adverse cardiac events (MACE) at 30days were defined as all-cause death, recurrent ACS, EST and stroke.Of the 4717 ACS patients who underwent PCI and stenting, 83% received clopidogrel and 17% newer P2Y12 inhibitors. The rate of EST was similar in both groups (1.7% in the newer P2Y12 inhibitor group vs. 1.4% in the clopidogrel-treated patients, p = 0.42). Results were consistent after multivariate analysis (adjusted HR = 1.06 [p = 0.89]). MACE occurred in 6.4% in the newer P2Y12 inhibitor group compared with 9.2% in the clopidogrel group (P<0.01). However, multivariate logistic regression modeling showed that treatment with newer P2Y12 inhibitors was not significantly associated with the secondary endpoint of MACE when compared with clopidogrel therapy [OR = 1.26 95%CI (0.93-1.73), P = 0.136]. The incidence of "real life" EST at 1month is relatively low, and appears to be similar in patients who receive newer P2Y12 inhibitors as well as in those who receive clopidogrel.

One swallow does not a summer make but many swallows do: accumulating clinical evidence for nearly-eliminated peri-procedural and 30-day complications with mesh-covered stents transforms the carotid revascularisation field

PubMed Central

Hopkins, L. Nelson; Siddiqui, Adnan H.

2017-01-01

Atherosclerotic carotid artery stenosis (CS) continues to be a common cause of acute ischaemic stroke. Optimised medical therapy (OMT), the first-line treatment modality in CS, may reduce or delay – but it does not abolish – CS-related strokes. As per current AHA/ASA and ESC/ESVS/ESO guidelines, carotid artery stenting (CAS) is a less-invasive alternative to carotid endarterectomy (CEA) for CS revascularisation in primary and secondary stroke prevention. Ten-year follow-up from the CREST trial in patients with symptomatic and asymptomatic CS confirmed equipoise of CAS and CEA in the primary endpoint. Nevertheless CAS – using a widely open-cell, first-generation stent and first-generation (distal/filter) neuroprotection – has been criticised for its relative excess of (mostly minor) strokes by 30 days, a significant proportion of which were post-procedural. Atherosclerotic plaque protrusion through conventional carotid stent struts, confirmed on intravascular imaging, has been implicated as a leading mechanism of the relative excess of strokes with CAS vs. CEA, including delayed strokes with CAS. Different designs of mesh-covered carotid stents have been developed to prevent plaque prolapse. Several multi-centre/multi-specialty clinical studies with CGurad MicroNet-Covered Embolic Prevention Stent System (EPS) and RoadSaver/Casper were recently published and included routine DW-MRI cerebral imaging peri-procedurally and at 30 days (CGuard EPS). Data from more than 550 patients in mesh-covered carotid stent clinical studies to-date show an overall 30-day complication rate of ~1% with near-elimination of post-procedural events. While more (and long-term) evidence is still anticipated, these results – taken together with optimised intra-procedural neuroprotection in CAS (increased use of proximal systems including trans-carotid dynamic flow reversal) and the positive 12-month mesh-covered stent data reports in 2017 – are transforming the carotid

Preliminary investigation of the effects of surface treatments on biological response to shape memory NiTi stents.

PubMed

Trépanier, C; Leung, T K; Tabrizian, M; Yahia, L H; Bienvenu, J G; Tanguay, J F; Piron, D L; Bilodeau, L

1999-01-01

Nickel-titanium (NiTi) offers many advantages for the fabrication of coronary stents: shape memory, superelasticity, and radiopacity. However, many authors highlighted the selective dissolution of Ni from the alloy during the corrosion process that could lead to potential toxicity. The improvement of the NiTi stent's corrosion resistance by different surface treatments (electropolishing, heat treatment, and nitric acid passivation) was reported in a previous article. In the present study a comparative biocompatibility evaluation of such stents was performed through in vitro and in vivo assays. A cell proliferation test was completed to evaluate the cytotoxicity of surface treated NiTi using human fibroblasts. Then a stent implantation was performed in rabbit paramuscular muscle to study the inflammatory response generated by the same implants. Cell proliferation tests generally indicated an in vitro biocompatibility of our samples similar to the control group. An in vivo implantation study demonstrated the gradual overall reduction with time of the fibrocellular capsule thickness surrounding the implants. After a 12-week implantation period, the fibrous capsules surrounding the different implants tended toward the same value of 0.07 mm, which suggested that all surface treatments produced a similar biological response. This low value of the fibrocellular capsule indicated that our NiTi surface treated implants were relatively inert.

Flow Characteristics Near to Stent Strut Configurations on Femoropopliteal Artery

NASA Astrophysics Data System (ADS)

Paisal, Muhammad Sufyan Amir; Fadhil Syed Adnan, Syed; Taib, Ishkrizat; Ismail, Al Emran; Kamil Abdullah, Mohammad; Nordin, Normayati; Seri, Suzairin Md; Darlis, Nofrizalidris

2017-08-01

Femoropopiteal artery stenting is a common procedure suggested by medical expert especially for patient who is diagnosed with severe stenosis. Many researchers reported that the growth of stenosis is significantly related to the geometry of stent strut configuration. The different shapes of stent geometry are presenting the different flow pattern and re-circulation in stented femoropopliteal artery. The blood flow characteristics near to the stent geometry are predicted for the possibility of thrombosis and atherosclerosis to be formed as well as increase the growth of stenosis. Thus, this study aims to determine the flow characteristic near to stent strut configuration based on different hemodynamic parameters. Three dimensional models of stent and simplified femoropopliteal artery are modelled using computer aided design (CAD) software. Three different models of stent shapes; hexagon, circle and rectangle are simulated using computational fluid dynamic (CFD) method. Then, parametric study is implemented to predict the performance of stent due to hemodynamic differences. The hemodynamic parameters considered are pressure, velocity, low wall shear stress (WSSlow) and wall shear stress (WSS). From the observation, flow re-circulation has been formed for all simulated stent models which the proximal region shown the severe vortices. However, rectangular shape of stent strut (Type P3) shows the lowest WSSlow and the highest WSS between the range of 4 dyne/cm2 and 70 dyne/cm2. Stent Type P3 also shows the best hemodynamic stent performance as compare to others. In conclusion, Type P3 has a favourable result in hemodynamic stent performance that predicted less probability of thrombosis and atherosclerosis to be formed as well as reduces the growth of restenosis.

A systematic review and meta-analysis of randomized trials and prospective studies comparing covered and bare self-expandable metal stents for the treatment of malignant obstruction in the digestive tract.

PubMed

Yang, Zhiping; Wu, Qiong; Wang, Fang; Ye, Xiaofei; Qi, Xingshun; Fan, Daiming

2013-01-01

Self-expandable metal stents (SEMS) are widely used for the palliative treatment of malignant gastrointestinal obstruction. Our aim was to evaluate the evidence comparing covered and bare SEMS in the digestive tract using meta-analytical techniques. A literature search was performed using PubMed, Cochrane Library, and Embase databases for comparative studies assessing the two types of stents. The primary outcomes of interest were stent patency and patient survival; second outcomes included technical success, clinical success, tumor ingrowth, tumor overgrowth, and stent migration. A random-effects model was conducted. Pooled analysis was done separately based on the different segments of the digestive tract. Eleven studies (8 randomized controlled trials and 3 prospective cohort studies) including a total of 1376 patients were identified. Covered SEMS were equivalent to bare SEMS in terms of technical success, clinical success, stent patency (gastroduodenal obstruction: HR =0.87, 95% CI 0.53-1.42; colorectal obstruction: HR =0.89, 95% CI 0.18-4.45; biliary obstruction: HR =0.73, 95% CI 0.41-1.32) and survival rates (esophageal obstruction: HR =1.80, 95% CI 0.73-4.44; gastroduodenal obstruction: HR =0.83, 95% CI 0.55-1.26; biliary obstruction: HR =0.99, 95% CI 0.77-1.28), although bare stents were more prone to tumor ingrowth (esophageal obstruction: RR =0.10, 95% CI 0.01-0.77; gastroduodenal obstruction: RR =0.12, 95% CI 0.03-0.55; colorectal obstruction: RR =0.21, 95% CI 0.06-0.70; biliary obstruction: RR =0.21, 95% CI 0.06-0.69), whereas covered stents had the higher risk of stent migration (gastroduodenal obstruction: RR =5.01, 95% CI 1.53-16.43; colorectal obstruction: RR =11.70, 95% CI 2.84-48.27; biliary obstruction: RR =8.11, 95% CI 1.47-44.76) and tumor overgrowth (biliary obstruction: RR =2.03, 95% CI 1.08-3.78). Both covered and bare SEMS are comparable in efficacy for the palliative treatment of malignant obstruction in the digestive tract. Each type of

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

In-situ observation of switchable nanoscale topography for y-shaped binary brushes in fluids.

PubMed

Lin, Yen-Hsi; Teng, Jing; Zubarev, Eugene R; Shulha, Hennady; Tsukruk, Vladimir V

2005-03-01

Direct, in-fluid observation of the surface morphology and nanomechanical properties of the mixed brushes composed of Y-shaped binary molecules PS-PAA revealed nanoscale network-like surface topography formed by coexisting stretched soluble PAA arms and collapsed insoluble PS chains in water. Placement of Y-shaped brushes in different fluids resulted in dramatic reorganization ranging from soft repellent layer covered by swollen PS arms in toluene to an adhesive, mixed layer composed of coexisting swollen PAA and collapsed PS arms in water. These binary layers with the overall nanoscale thickness can serve as adaptive nanocoatings with stimuli-responsive properties.

Fenestration of a Papyrus PK covered stent to recover the occluded left main bifurcation after sealing a left main perforation during a CTO procedure.

PubMed

Werner, Gerald S; Ahmed, Waqar H

2017-09-01

Covered stents are indicated for coronary perforations, but they may seal off major side branches in that process. We report the successful sealing of an ostial left main perforation, induced by a guide catheter in the course of a retrograde approach to treat a chronic total occlusion (CTO) of the right coronary artery (RCA) in a 76year old woman with prior CABG. The implanted Papyrus covered stent, however, overlapped the left main bifurcation and occluded the non-grafted circumflex artery (CX) resulting in acute ischemia. Through a double lumen catheter advanced over the wire located in the left anterior descending coronary artery (LAD) territory, a stiff recanalization wire could be advanced from the side-port to penetrate the stent membrane towards the CX. This was successfully achieved, and after subsequent dilatation, a drug-eluting stent was implanted in Culotte-fashion from the CX to the left main with subsequent kissing-balloon dilatation. The clinical symptoms subsided immediately, and the RCA was finally recanalized in antegrade parallel wire technique. No periprocedural infarct was observed during 48h of follow-up before discharge. At clinical follow-up of 6months the patient is symptom-free. Copyright © 2017 Elsevier Inc. All rights reserved.

Predictors of outcomes in patients undergoing covered and uncovered self-expandable metal stent placement for malignant gastric outlet obstruction: a multicenter study.

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

2017-02-01

Uncovered self-expandable metal stents (U-SEMSs) and covered self-expandable metal stents (C-SEMSs) are available for palliative therapy for malignant gastric outlet obstruction (GOO). However, clinical differences and indications between the 2 types of SEMSs have not been elucidated. We retrospectively compared 126 patients with U-SEMS and 126 patients with C-SEMSs with regard to clinical outcome and factors predictive of clinical improvement after SEMSs placement. No significant difference was observed between the U-SEMS and C-SEMS groups with respect to technical success, clinical success, GOO score, or time to stent dysfunction. Stent migration was significantly more frequent in patients with C-SEMSs (U-SEMSs, .79%; C-SEMSs, 8.73%; P = .005). Karnofsky performance status, chemotherapy, peritoneal dissemination, and stent expansion ≤ 30% were associated significantly with poor GOO score improvement in multivariable analyses, but stent type was not (P = .213). In subgroup analyses, insufficient (≤30%) stent expansion was an independent factor in patients with U-SEMSs (P = .041) but not C-SEMSs. In the insufficient stent expansion subgroup, C-SEMSs was associated significantly with superior clinical improvement compared with U-SEMSs (P = .01). Insufficient stent expansion was observed more frequently in patients with GI obstruction because of anastomotic sites or metastatic cancer (44.8% [13/29], P = .001). No clinical difference, apart from stent migration, was observed between patients with U-SEMSs and C-SEMSs. GI obstruction because of an anastomotic site or metastatic cancer may be an indication for C-SEMS use to improve oral intake after SEMSs placement. Copyright © 2017 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

Characterization of compression behaviors of fully covered biodegradable polydioxanone biliary stent for human body: A numerical approach by finite element model.

PubMed

Liu, Yanhui; Zhang, Peihua

2016-09-01

This paper presents a study of the compression behaviors of fully covered biodegradable polydioxanone biliary stents (FCBPBs) developed for human body by finite element method. To investigate the relationship between the compression force and structure parameter (monofilament diameter and braid-pin number), nine numerical models based on actual biliary stent were established, the simulation and experimental results are in good agreement with each other when calculating the compression force derived from both experiment and simulation results, indicating that the simulation results can be provided a useful reference to the investigation of biliary stents. The stress distribution on FCBPBSs was studied to optimize the structure of FCBPBSs. In addition, the plastic dissipation analysis and plastic strain of FCBPBSs were obtained via the compression simulation, revealing the structure parameter effect on the tolerance. Copyright © 2016 Elsevier Ltd. All rights reserved.

Endoscopic Management of Post-Liver Transplantation Biliary Strictures With the Use of Fully Covered Metallic Stents.

PubMed

Jiménez-Pérez, M; Melgar Simón, J M; Durán Campos, A; González Grande, R; Rodrigo López, J M; Manteca González, R

2016-09-01

The aim of this work was to evaluate the safety and efficacy of a fully covered self-expandable metal stent (FCSEMS) in the treatment of post-liver transplantation biliary strictures. From October 2009 to October 2014, 44 patients with post-liver transplantation biliary stenosis were treated with the use of endoscopic retrograde cholangiography and placement of FCSEMS after informed consent. The FCSEMS was scheduled to remain in situ for 3-6 months. Patients were followed at regular intervals to evaluate for symptoms and liver function tests. Technical success, complications, and patient outcome were analyzed. All of the strictures were anastomotic, 52% having occurred within the 1st year following the transplantation. Placement of the FCSEMS was possible on the 1st attempt in 54% of patients. Stricture resolution at the time of stent removal was seen in 100% of the cases. During an average follow-up of 27.83 ± 18.3 months after stent removal, stenosis recurred in 9 out of 41 patients (21.9%). The average time of recurrence was 11.78 ± 13.3 months. In all of these cases, the recurrence was resolved by means of placement of another FCSEMS. In 4 cases, the recurrence was associated with a migration of the prosthesis, partial in 2 cases and total in 2 cases. Stent migration occurred in a total of 17 of the 41 patients (41.4%), in 13 of the 32 (40.6%) who had no recurrence of stenosis and in 4 of the 9 (44.4%) of those who experienced recurrence. The average numbers of endoscopic retrograde cholangiography studies required per patient were 2.8 in those with no recurrence and 3.3 in those with recurrence. No death was associated with the process. FCSEMS is a safe effective alternative to plastic stents in the treatment of post-transplantation biliary strictures, resulting in a lower risk of complications and better patient acceptance. Copyright © 2016 Elsevier Inc. All rights reserved.

A Prospective, Multicenter Study of a Novel Mesh-Covered Carotid Stent: The CGuard CARENET Trial (Carotid Embolic Protection Using MicroNet).

PubMed

Schofer, Joachim; Musiałek, Piotr; Bijuklic, Klaudija; Kolvenbach, Ralf; Trystula, Mariusz; Siudak, Zbigniew; Sievert, Horst

2015-08-17

This study sought to evaluate the feasibility of the CGuard Carotid Embolic Protective Stent system-a novel thin strut nitinol stent combined with a polyethylene terephthalate mesh covering designed to prevent embolic events from the target lesion in the treatment of carotid artery lesions in consecutive patients suitable for carotid artery stenting. The risk of cerebral embolization persists throughout the carotid artery stenting procedure and remains during the stent healing period. A total of 30 consecutive patients (age 71.6 ± 7.6 years, 63% male) meeting the conventional carotid artery stenting inclusion criteria were enrolled in 4 centers in Germany and Poland. The primary combined endpoint was the procedure success of the CGuard system and the number and volume of new lesions on the ipsilateral side assessed by diffusion-weighted magnetic resonance imaging at 48 h post-procedure and at 30 days. The secondary endpoint was 30-day major adverse cardiac or cerebrovascular events (death, stroke, or myocardial infarction). Protection devices were used in all procedures. Procedure success was 100%, with 0% procedural complications. The 30-day major adverse cardiac or cerebrovascular events rate was 0%. New ipsilateral ischemic lesions at 48 h occurred in 37.0% of patients and the average lesion volume was 0.039 ± 0.08 cm(3). The 30-day diffusion-weighted magnetic resonance imaging showed complete resolution of all but 1 periprocedural lesion and only 1 new minor (0.116 cm(3)) lesion in relation to the 48-h scan. The use of the CGuard system in patients undergoing carotid artery stenting is feasible. In addition, the benefit of using CGuard may extend throughout the stent healing period. Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

No Distal Migration in Unfixed Versus Fixed Cell Structure Covered Self-Expanding Metal Stents for Treatment of Benign Biliary Disease.

PubMed

Walter, Dirk; Sarrazin, Christoph; Trojan, Jörg; Kronenberger, Bernd; Bojunga, Jörg; Zeuzem, Stefan; Friedrich-Rust, Mireen; Albert, Jörg G

2015-08-01

Fully covered self-expandable metal stents (FCSEMS) are increasingly used for treatment of benign common bile duct (CBD) stricture or leakage, but dislodgement of FCSEMS is frequent. To compare dislocation rate and clinical outcome of a standard fixed cell structure FCSEMS (S-FCSEMS) to a novel FCSEMS with an unfixed cell structure (N-FCSEMS). We performed a retrospective analysis of all patients with FCSEMS insertion for benign biliary disease at our Hospital from 03/2008 to 03/2014. Both stent types N-FCSEMS and S-FCSEMS were applied as available unrelated to the indication. Twenty-nine patients (S-FCSEMS: 18, N-FCSEMS: 11) were included. Stent placement was technically successful in 28/29 (96.6 %) patients; stent removal was successful in 26/27 (96.2 %). Two patients with N-FCSEMS were excluded due to unsuccessful placement and withdrawal of consent for stent removal, respectively. Stent migration into the duodenum (distal migration) was observed in 9/18 (50 %) in the S-FCSEMS group compared to 0/9 in the N-FCSEMS (p < 0.005). FCSEMS migration into the CBD (proximal migration) was found in 2/18 (11 %, S-FCSEMS) versus 2/9 (22 %, N-FCSEMS, p = 0.514). A foreshortening of the N-FCSEMS occurred in 3/9 patients (33 %) compared to 0/18 S-FCSEMS (p = 0.08). Clinical resolution of the treated CBD-disease was observed in 5/9 (56 %, N-FCSEMS) versus 12/18 (67 %, S-FCSEMS) at the time of stent removal (p = 0.604) and in 0/9 and 10/18 (56 %) cases during follow-up, respectively (p < 0.005). An unfixed cell structure of FCSEMS seems to prevent distal migration, but proximal migration still occurs and foreshortening of the N-FCSEMS constrains clinical outcome.

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.

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

[Stent-assisted recanalization of femoropopliteal arterial occlusive disease. Influence of stent design on patency rates].

PubMed

Treitl, M; Reiser, M F; Treitl, K M

2016-03-01

Despite enormous technical progress the results of endovascular treatment of the femoropopliteal vasculature are unsatisfactory and its role is still controversially discussed. In the past decade numerous new stent designs have come onto the market but it is unclear whether they have benefits with respect to patency rates. Comparison of published data on patency rates and target lesion revascularization rates after use of different stent designs in the femoropopliteal vasculature. Analysis of 25 published studies and registries from 2006 to 2015 for classical open-cell stents, interwoven stents and partially or fully covered stents. The published data are heterogeneous and comparative studies for different stent designs are completely missing. Over the past decade the patency rates after femoropopliteal stenting could be improved. According to available data stenting of short lesions < 5 cm does not show any benefit compared to isolated balloon angioplasty. Primary stenting is now recommended for intermediate and longer lesions > 6.4 cm. Due to the heterogeneity of published data a clear benefit for a specific stent design is not obvious; however, data for interwoven stents are promising and show a tendency towards improved patency, at least for certain lesions. Randomized controlled comparative trials are needed to confirm this result.

[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.

Heparin-bonded covered stents versus bare-metal stents for complex femoropopliteal artery lesions: the randomized VIASTAR trial (Viabahn endoprosthesis with PROPATEN bioactive surface [VIA] versus bare nitinol stent in the treatment of long lesions in superficial femoral artery occlusive disease).

PubMed

Lammer, Johannes; Zeller, Thomas; Hausegger, Klaus A; Schaefer, Philipp J; Gschwendtner, Manfred; Mueller-Huelsbeck, Stefan; Rand, Thomas; Funovics, Martin; Wolf, Florian; Rastan, Aljoscha; Gschwandtner, Michael; Puchner, Stefan; Ristl, Robin; Schoder, Maria

2013-10-08

The hypothesis that endovascular treatment with covered stents has equal risks but higher efficacy than bare-metal stents (BMS) in long femoropopliteal artery disease was tested. Although endovascular treatment of short superficial femoral artery lesions revealed excellent results, efficacy in long lesions remains unsatisfactory. In a prospective, randomized, single-blind, multicenter study, 141 patients with symptomatic peripheral arterial disease were assigned to treatment with heparin-bonded, covered stents (Viabahn 72 patients) or BMS (69 patients). Clinical outcomes and patency rates were assessed at 1, 6, and 12 months. Mean ± SD lesion length was 19.0 ± 6.3 cm in the Viabahn group and 17.3 ± 6.6 cm in the BMS group. Major complications within 30 days were observed in 1.4%. The 12-month primary patency rates in the Viabahn and BMS groups were: intention-to-treat (ITT) 70.9% (95% confidence interval [CI]: 0.58 to 0.80) and 55.1% (95% CI: 0.41 to 0.67) (log-rank test p = 0.11); treatment per-protocol (TPP) 78.1% (95% CI: 0.65 to 0.86) and 53.5% (95% CI: 0.39 to 0.65) (hazard ratio: 2.23 [95% CI: 1.14 to 4.34) (log-rank test p = 0.009). In lesions ≥20 cm, (TransAtlantic Inter-Society Consensus class D), the 12-month patency rate was significantly longer in VIA patients in the ITT analysis (VIA 71.3% vs. BMS 36.8%; p = 0.01) and the TPP analysis (VIA 73.3% vs. BMS 33.3%; p = 0.004). Freedom from target lesion revascularization was 84.6% for Viabahn (95% CI: 0.72 to 0.91) versus 77.0% for BMS (95% CI: 0.63 to 0.85; p = 0.37). The ankle-brachial index in the Viabahn group significantly increased to 0.94 ± 0.23 compared with the BMS group (0.85 ± 0.23; p < 0.05) at 12 months. This randomized trial in symptomatic patients with peripheral arterial disease who underwent endovascular treatment for long femoropopliteal lesions demonstrated significant clinical and patency benefits for heparin-bonded covered stents compared with BMS in lesions ≥20 cm and for all

Evaluation of Polyurethane Nasolacrimal Duct Stents: In Vivo Studies in New Zealand Rabbits

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

Wilhelm, K.E., E-mail: wilhelm@uni-bonn.de; Grabolle, B.; Urbach, H.

2006-10-15

The purpose of this study was to evaluate the radiographic and biological effects of different polyurethane nasolacrimal duct stents in an animal model. Fifteen polyurethane nasolacrimal duct stents (n = 5 mushroom-type stents, n = 5 newly designed S-shaped TearLeader stents without hydrophilic coating, and n = 5 S-shaped TearLeader stents with hydrophilic coating) were implanted in the nasolacrimal ducts of eight unaffected New Zealand rabbits. One nasolacrimal system served as control. Clinical and radiographic follow-up was performed at 1-, 2-, and 4-week intervals, then after a 3-month interval, after which the animals were euthanized. All stents were implanted withoutmore » major periprocedural complications. The stents proved to be patent by the end of the procedure. During follow-up, all mushroom-type stents were occluded at 4 weeks. None of these stents opened to forced irrigation. Clinically, all rabbits demonstrated severe dacryocystitis. Three out of five TearLeader stents without hydrophilic coating were blocked at 4 weeks; one out of five was open to irrigation. Best results were observed in the stent group with hydrophilic coating. Follow-up dacryocystography demonstrated patent stents in nasolacrimal ducts of all animals after 4 weeks. In only one of five cases, the coated stent became partially occluded after 2 months. These animals were free of clinical symptoms. After 3 months, at least three out of five stents still opened to forced irrigation and only one stent was completely blocked. Dislocation of the stents was not observed. Refinement of the stent surface and stent design improves the results of nasolacrimal duct stenting in this animal model. Implantation of hydrophilic-coated S-shaped stents is highly superior to conventional mushroom-type stents and noncoated stent types. Hydrophilic coating seems to prevent foreign-body reactions, resulting in maximized stent patency.« less

Comparison of the influence of plastic and fully covered metal biliary stents on the accuracy of EUS-FNA for the diagnosis of pancreatic cancer.

PubMed

Siddiqui, Ali A; Fein, Michael; Kowalski, Thomas E; Loren, David E; Eloubeidi, Mohamad A

2012-09-01

Prior studies have reported that the presence of prior biliary stent may interfere with EUS visualization of pancreatic tumors. We aimed to compare the influence of the biliary plastic and fully covered self-expanding metal stents (CSEMS) on the accuracy of EUS-FNA cytology in patients with solid pancreatic masses. We conducted a retrospective study evaluating 677 patients with solid pancreatic head/uncinate lesions and a previous biliary stent in whom EUS-FNA was performed. The patients were stratified into two groups: (1) those with a plastic stents and (2) those with CSEMS. Performance characteristics of EUS-FNA including the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy were compared between the two groups. The frequency of obtaining an adequate cytology by EUS-FNA was similar in both the CSEMS group and the plastic stent group (97 vs. 97.1 % respectively; p = 1.0). The sensitivity, specificity, and accuracy of EUS-FNA was not significantly different between patients with CSEMS and plastic stents (96.8, 100, 100 % and 97.3, 98, 99.8 %, respectively). The negative predictive value for EUS-FNA was lower in the CSEMS group compared to the plastic stent group (66.6 vs. 78.1 % respectively; p = 0.42). There was one false-positive cytology in the plastic stent group compared to none in the CSEMS group. In a retrospective cohort trial, EUS-FNA was found to be highly accurate and safe in diagnosing patients with suspected pancreatic cancer, even in the presence of a plastic or metallic biliary stent. The presence of a stent did not contribute to a higher false-positive cytology rate.

Migrated esophageal stent posing a challenge for ventilation.

PubMed

D'souza, Nita; Arbhi, Sachin; Dikshit, Amit; Ghadge, Murarji; Jha, Smriti

2017-01-01

Self-expandable esophageal stents are being commonly used for palliative treatment in advanced esophageal cancer patients to relieve dysphagia, prevent tracheoesophageal fistula, and facilitate symptomatic betterment. The modern covered stents reduce the ingrowth of the tumor but have seen an increase in the incidence of stent migrations. We report a rather complicated presentation of an esophageal stent for esophageal dilatation and a challenging management of a difficult tracheostomy.

Effective treatment of benign biliary strictures with a removable, fully covered, self-expandable metal stent: A prospective, multicenter European study.

PubMed

Schmidt, Arthur; Pickartz, Tilman; Lerch, Markus M; Fanelli, Fabrizio; Fiocca, Fausto; Lucatelli, Pierleone; Cereatti, Fabrizio; Hoffmeister, Albrecht; van Steenbergen, Werner; Kraft, Matthias; Meier, Benjamin; Caca, Karel

2017-04-01

Temporary placement of removable, fully covered, self-expandable metal stents (fcSEMS) for treatment of benign biliary strictures (BBS) has been reported to be effective. However, the optimal extraction time point remains unclear and stent migration has been a major concern. The objective of this study was to evaluate the efficacy and safety of this treatment modality using an fcSEMS with a special antimigration design and prolonged stent indwell time. We performed a prospective, single-arm study at six tertiary care centers in Europe. Patients with BBS underwent endoscopic or percutaneous implantation of an fcSEMS (GORE® VIABIL® Biliary Endoprosthesis, W.L. Gore & Associates, Flagstaff, AZ, USA). The devices were scheduled to be removed nine months later, and patients were to return for follow-up for an additional 15 months. Forty-three patients were enrolled in the study. Stricture etiology was chronic pancreatitis in the majority of patients (57.5%). All fcSEMS were placed successfully, either endoscopically (76.7%) or percutaneously (23.3%). Stent migration was observed in two patients (5.2%). Primary patency of the SEMS prior to removal was 73.0%. All attempted stent removals were successful. At removal, stricture was resolved or significantly improved without need for further therapy in 78.9% of patients. Stricture recurrence during a follow-up of two years post-implant was observed in two patients. Temporary placement of the fcSEMS is a feasible, safe and effective treatment for BBS. The design of the device used in this study accounts for very low migration rates and facilitates easy stent retrieval, even after it has been in place for up to 11 months.

Effective treatment of benign biliary strictures with a removable, fully covered, self-expandable metal stent: A prospective, multicenter European study

PubMed Central

Schmidt, Arthur; Pickartz, Tilman; Lerch, Markus M; Fanelli, Fabrizio; Fiocca, Fausto; Lucatelli, Pierleone; Cereatti, Fabrizio; Hoffmeister, Albrecht; van Steenbergen, Werner; Kraft, Matthias; Meier, Benjamin

2016-01-01

Background Temporary placement of removable, fully covered, self-expandable metal stents (fcSEMS) for treatment of benign biliary strictures (BBS) has been reported to be effective. However, the optimal extraction time point remains unclear and stent migration has been a major concern. Objective The objective of this study was to evaluate the efficacy and safety of this treatment modality using an fcSEMS with a special antimigration design and prolonged stent indwell time. Methods We performed a prospective, single-arm study at six tertiary care centers in Europe. Patients with BBS underwent endoscopic or percutaneous implantation of an fcSEMS (GORE® VIABIL® Biliary Endoprosthesis, W.L. Gore & Associates, Flagstaff, AZ, USA). The devices were scheduled to be removed nine months later, and patients were to return for follow-up for an additional 15 months. Results Forty-three patients were enrolled in the study. Stricture etiology was chronic pancreatitis in the majority of patients (57.5%). All fcSEMS were placed successfully, either endoscopically (76.7%) or percutaneously (23.3%). Stent migration was observed in two patients (5.2%). Primary patency of the SEMS prior to removal was 73.0%. All attempted stent removals were successful. At removal, stricture was resolved or significantly improved without need for further therapy in 78.9% of patients. Stricture recurrence during a follow-up of two years post-implant was observed in two patients. Conclusions Temporary placement of the fcSEMS is a feasible, safe and effective treatment for BBS. The design of the device used in this study accounts for very low migration rates and facilitates easy stent retrieval, even after it has been in place for up to 11 months. PMID:28507752

Carotid artery stenting: current and emerging options

PubMed Central

Morr, Simon; Lin, Ning; Siddiqui, Adnan H

2014-01-01

Carotid artery stenting technologies are rapidly evolving. Options for endovascular surgeons and interventionists who treat occlusive carotid disease continue to expand. We here present an update and overview of carotid stenting devices. Evidence supporting carotid stenting includes randomized controlled trials that compare endovascular stenting to open surgical endarterectomy. Carotid technologies addressed include the carotid stents themselves as well as adjunct neuroprotective devices. Aspects of stent technology include bare-metal versus covered stents, stent tapering, and free-cell area. Drug-eluting and cutting balloon indications are described. Embolization protection options and new direct carotid access strategies are reviewed. Adjunct technologies, such as intravascular ultrasound imaging and risk stratification algorithms, are discussed. Bare-metal and covered stents provide unique advantages and disadvantages. Stent tapering may allow for a more fitted contour to the caliber decrement between the common carotid and internal carotid arteries but also introduces new technical challenges. Studies regarding free-cell area are conflicting with respect to benefits and associated risk; clinical relevance of associated adverse effects associated with either type is unclear. Embolization protection strategies include distal filter protection and flow reversal. Though flow reversal was initially met with some skepticism, it has gained wider acceptance and may provide the advantage of not crossing the carotid lesion before protection is established. New direct carotid access techniques address difficult anatomy and incorporate sophisticated flow-reversal embolization protection techniques. Carotid stenting is a new and exciting field with rapidly advancing technologies. Embolization protection, low-risk deployment, and lesion assessment and stratification are active areas of research. Ample room remains for further innovations and developments. PMID:25349483

Mechanical behavior of deformed intravascular NiTi stents differing in design. Numerical simulation

NASA Astrophysics Data System (ADS)

Eremina, Galina M.; Smolin, Alexey Yu.; Krukovskii, Konstantin V.; Lotkov, Aleksandr I.; Kashin, Oleg A.; Kudryashov, Andrey N.

2017-12-01

Self-expanding intravascular NiTi stents serve to recover the lumen of vessels suffered from atherosclerotic stenosis. During their manufacturing or functioning in blood vessels, the stents experience different strains and local stresses that may result in dangerous defects or fracture. Here, using the method of movable cellular automata, we analyze how the design of a stent influences its stress state during shaping to a desired diameter on a mandrel. We consider repeated segments of different stents under two loads: uniform diametric expansion of their crown and expansion with relative displacements. The simulation data agree well with experiments, revealing critical strain, stress, and their localization sites at the shaping stage, and provide the way toward optimum stent designs to minimize the critical stress during shaping.

The use of double lasso, fully covered self-expandable metal stents with new "anchoring flap" system in the treatment of benign biliary diseases.

PubMed

Mangiavillano, B; Manes, G; Baron, T H; Frego, R; Dinelli, M; Radaelli, F; Teruzzi, V; Amato, A; Pallotta, S; Santoro, T; Masci, E

2014-09-01

Many benign biliary diseases (BBD) can be treated with fully covered, self-expandable metal stents (FCSEMS) but stent migration occurs in up to 35.7 %. The aim of this study was to prospectively assess the rate of, safety and effectiveness and stent migration of a new biliary FCSEMS with an anti-migration flap (FCSEMS-AF) in patients with BBD. This was a prospective study from four Italian referral endoscopy centers of 32 consecutive patients (10 females and 22 males; mean age: 60.1 ± 14.8 years; range: 32-84 years) with BBD who were offered endoscopic placement of a FCSEMS-AF as first-line therapy. Were 24 strictures and 8 leaks. Stent placement was technically successful in 32/32 patients (100 %). Immediate clinical improvement was seen in all 32 patients (100 %). One late stent migration occurred (3.3 %). FCSEMS-AF were removed from 30 of the 32 patients (93.7 %) at a mean (± SD) of 124.4 ± 84.2 days (range: 10-386 days) after placement. All patients remained clinically and biochemically well at 1- and 3-month follow-up. One patient (3.3 %) with a post-laparoscopic cholecystectomy stricture developed distal stent migration at 125 days. This new FCSEMS with anti-migration flap seems to be a safe and effective first-line treatment option for patients with BBD.

Endovascular Treatment of Splenic Artery Aneurysm With a Stent-Graft: A Case Report.

PubMed

Guang, Li-Jun; Wang, Jian-Feng; Wei, Bao-Jie; Gao, Kun; Huang, Qiang; Zhai, Ren-You

2015-12-01

Splenic artery aneurysm, one of the most common visceral aneurysms, accounts for 60% of all visceral aneurysm cases. Open surgery is the traditional treatment for splenic artery aneurysm but has the disadvantages of serious surgical injuries, a high risk of complications, and a high mortality rate.We report a case who was presented with splenic artery aneurysm. A 54-year-old woman complained of upper left abdominal pain for 6 months. An enhanced computed tomography scan of the upper abdomen indicated the presence of splenic artery aneurysm. The splenic artery aneurysm was located under digital subtraction angiography and a 6/60 mm stent graft was delivered and released to cover the aneurysm. An enhanced computed tomography scan showed that the splenic artery aneurysm remained well separated, the stent graft shape was normal, and the blood flow was unobstructed after 1 year.This case indicates a satisfactory efficacy proving the minimal invasiveness of stent graft exclusion treatment for splenic artery aneurysm.

Complications of stent placement in patients with esophageal cancer: A systematic review and network meta-analysis

PubMed Central

Doosti-Irani, Amin; Mansournia, Mohammad Ali; Rahimi-Foroushani, Abbas; Haddad, Peiman

2017-01-01

Background Palliative treatments and stents are necessary for relieving dysphagia in patients with esophageal cancer. The aim of this study was to simultaneously compare available treatments in terms of complications. Methods Web of Science, Medline, Scopus, Cochrane Library and Embase were searched. Statistical heterogeneity was assessed using the Chi2 test and was quantified by I2. The results of this study were summarized in terms of Risk Ratio (RR). The random effects model was used to report the results. The rank probability for each treatment was calculated using the p-score. Results Out of 17855 references, 24 RCTs reported complications including treatment related death (TRD), bleeding, stent migration, aspiration, severe pain and fistula formation. In the ranking of treatments, thermal ablative therapy (p-score = 0.82), covered Evolution® stent (p-score = 0.70), brachytherapy (p-score = 0.72) and antireflux stent (p-score = 0.74) were better treatments in the network of TRD. Thermal ablative therapy (p-score = 0.86), the conventional stent (p-score = 0.62), covered Evolution® stent (p-score = 0.96) and brachytherapy (p-score = 0.82) were better treatments in the network of bleeding complications. Covered Evolution® (p-score = 0.78), uncovered (p-score = 0.88) and irradiation stents (p-score = 0.65) were better treatments in network of stent migration complications. In the network of severe pain, Conventional self-expandable nitinol alloy covered stent (p-score = 0.73), polyflex (p-score = 0.79), latex prosthesis (p-score = 0.96) and brachytherapy (p-score = 0.65) were better treatments. Conclusion According to our results, thermal ablative therapy, covered Evolution® stents, brachytherapy, and antireflux stents are associated with a lower risk of TRD. Moreover, thermal ablative therapy, conventional, covered Evolution® and brachytherapy had lower risks of bleeding. Overall, fewer complications were associated with covered Evolution® stent and

Endoscopic stent suture fixation for prevention of esophageal stent migration during prolonged dilatation for achalasia treatment.

PubMed

Rieder, E; Asari, R; Paireder, M; Lenglinger, J; Schoppmann, S F

2017-04-01

The aim of this study is to compare endoscopic stent suture fixation with endoscopic clip attachment or the use of partially covered stents (PCS) regarding their capability to prevent stent migration during prolonged dilatation in achalasia. Large-diameter self-expanding metal stents (30 mm × 80 mm) were placed across the gastroesophageal junction in 11 patients with achalasia. Stent removal was scheduled after 4 to 7 days. To prevent stent dislocation, endoscopic clip attachment, endoscopic stent suture fixation, or PCS were used. The Eckardt score was evaluated before and 6 months after prolonged dilatation. After endoscopic stent suture fixation, no (0/4) sutured stent migrated. When endoscopic clips were used, 80% (4/5) clipped stents migrated (p = 0.02). Of two PCS (n = 2), one migrated and one became embedded leading to difficult stent removal. Technical adverse events were not seen in endoscopic stent suture fixation but were significantly correlated with the use of clips or PCS (r = 0.828, p = 0.02). Overall, 72% of patients were in remission regarding their achalasia symptoms 6 months after prolonged dilatation. Endoscopic suture fixation of esophageal stents but not clip attachment appears to be the best method of preventing early migration of esophageal stents placed at difficult locations such as at the naive gastroesophageal junction. © The Authors 2017. Published by Oxford University Press on behalf of International Society for Diseases of the Esophagus. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

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.

Outcomes of endoscopically inserted self-expandable metal stents in malignancy according to the type of stent and the site of obstruction.

PubMed

Jung, Kyoungwon; Ahn, Ji Yong; Jung, Hwoon-Yong; Cho, Charles J; Na, Hee Kyong; Jung, Kee Wook; Lee, Jeong Hoon; Kim, Do Hoon; Choi, Kee Don; Song, Ho June; Lee, Gin Hyug; Kim, Jin-Ho

2016-09-01

Self-expandable metal stents (SEMSs) can be used for the palliation of malignant obstruction in the upper gastrointestinal tract. This study assessed the feasibility and efficacy of endoscopically inserted SEMSs for the palliation of malignant obstruction in the stomach and duodenum. Between January 2011 and April 2014, 220 patients with gastric or duodenal obstruction due to malignancy underwent endoscopic SEMS insertion at Asan Medical Center. The associations of technical/clinical outcomes and complications with the type of stent and site of obstruction were analyzed. The 220 patients included 125 men (56.8 %) and 95 women (43.2 %); median patient age was 63 years. Fully covered, partially covered, and uncovered SEMSs were inserted into 16, 77, and 120 patients, respectively. Obstructions were located in the gastric outlet, including the duodenal bulb, in 106 patients, and in the duodenal second and third portions in 114 patients. Technical success was achieved in 213 of 220 patients (96.8 %) and clinical success in 184 of 213 (86.4 %). Clinical success rates were similar to the type of stent, but were significantly greater for gastric outlet (95/104, 91.3 %) than for duodenal (89/109, 81.7 %) obstructions (p = 0.039). Stent migration was observed in 20 patients (9.1 %) and stent obstruction in 51 (23.2 %). Rates of stent migration were significantly higher for fully covered (6/16, 37.5 %) than for partially covered (7/77, 9.1 %) and uncovered (7/120, 5.8 %) SEMSs (p < 0.001) and were significantly higher for gastric outlet (16/104, 15.4 %) than for duodenal (4/109, 1.2 %) obstructions (p = 0.003). Rates of stent obstruction were similar for fully covered (2/16, 12.5 %), partially covered (17/77, 22.1 %), and uncovered (32/120, 26.7 %) SEMSs (p = 0.409) and in patients with gastric outlet (26/104, 25.0 %) and duodenal (25/109, 22.9 %) obstruction (p = 0.724). SEMS selection for malignant obstruction of the upper gastrointestinal

Percuflex Helical Ureteral Stents Significantly Reduce Patient Analgesic Requirements Compared to Control Stents.

PubMed

Chew, Ben H; Rebullar, Karla A; Harriman, David; McDougall, Elspeth; Paterson, Ryan F; Lange, Dirk

2017-12-01

Ureteral stent symptoms are experienced by the majority of patients with ureteral stents. No one stent or technology has shown a clear advantage. The Helical™ stent, a spirally cut stent made of proprietary Percuflex™ material, was designed to conform to the shape of the ureter and better accommodate patient movement. We prospectively sought to compare unscheduled visits, analgesic use, and pain scores in patients who received a Percuflex Helical ureteral stent following ureteroscopy compared to a historical control group. Fifteen (n = 15) patients undergoing ureteroscopy for the treatment of kidney stones were consented for study. A Percuflex Helical ureteral stent was inserted after treating the urinary stone. The historical control group consisted of 30 patients, from a previous (ketorolac eluting) ureteral stent study utilizing the same protocol and clinical monitoring forms, who received a regular Percuflex ureteral stent. The control patients were matched by age and sex. The primary study outcome was to compare unscheduled visits. Secondary outcomes included comparison of Visual Pain Analog Scale (VPAS) scores and analgesic use between the two groups. There were no differences in the gender, age, BMI, or stone characteristics between groups. Both groups underwent retrograde ureteroscopy using holmium:YAG laser lithotripsy and stone fragmentation. There was a significant reduction in the amount of analgesics required in the Helical stent group (4.4 ± 7.99 mg morphine equivalents) compared to controls (16.75 ± 18.31 mg, p = 0.0035) to achieve similar VPAS scores. There was no difference in unscheduled visits (20%) or VPAS scores (13.84 ± 13.68 helical vs 14.29 ± 11.58 control, p = 0.7910) between groups. Patients who received a Percuflex Helical ureteral stent required significantly fewer analgesics than those who received a Percuflex stent and both had equivalent pain scores.

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.

Preoperative biliary drainage using a fully covered self-expandable metallic stent for pancreatic head cancer: A prospective feasibility study.

PubMed

Togawa, Osamu; Isayama, Hiroyuki; Kawakami, Hiroshi; Nakai, Yousuke; Mohri, Dai; Hamada, Tsuyoshi; Kogure, Hirofumi; Kawakubo, Kazumichi; Sakamoto, Naoya; Koike, Kazuhiko; Kita, Hiroto

2018-01-01

The role of endoscopic preoperative biliary drainage (PBD) for pancreatic head cancer is controversial because of the high incidence of stent occlusion before surgery. This study was performed to evaluate the feasibility and safety of PBD using a fully covered self-expandable metallic stent (FCSEMS). This multicenter prospective study involved 26 patients treated for pancreatic head cancer with distal bile duct obstruction from April 2011 to March 2013. An FCSEMS was endoscopically placed in 24 patients. Among these, 7 patients were diagnosed with unresectable cancer, and 17 underwent surgery at a median of 18 days after FCSEMS placement. The main outcome measure was preoperative and postoperative adverse events. Two adverse events (cholecystitis and insufficient resolution of jaundice) occurred between FCSEMS placement and surgery (12%). Postoperative adverse events occurred in eight patients (47%). The cumulative incidence of stent-related adverse events 4 and 8 weeks after FCSEMS placement among the 24 patients who underwent this procedure were 19%. PBD using an FCSEMS is feasible in patients with resectable pancreatic head cancer. Placement of an FCSEMS can be an alternative PBD technique when surgery without delay is impossible. A larger randomized controlled trial is warranted.

Esophageal leiomyoma in a dog causing esophageal distension and treated by transcardial placement of a self-expanding, covered, nitinol esophageal stent.

PubMed

Robin, Elisabeth M; Pey, Pascaline B; de Fornel-Thibaud, Pauline; Moissonnier, Pierre H M; Freiche, Valérie

2018-02-01

CASE DESCRIPTION A 10-year-old spayed female Rottweiler was referred for evaluation because of a 2-month history of regurgitation and weight loss, despite no apparent change in appetite. The dog had received antiemetic and antacid treatment, without improvement. CLINICAL FINDINGS Physical examination revealed a low body condition score (2/5), but other findings were unremarkable. Diffuse, global esophageal dilatation was noted on plain thoracic radiographs, and normal motility was confirmed through videofluoroscopic evaluation of swallowing. Transhepatic ultrasonographic and CT examination revealed a circumferential, intraparietal lesion in the distal portion of the esophagus causing distal esophageal or cardial subobstruction and no metastases. Incisional biopsy of the lesion was performed, and findings of histologic examination supported a diagnosis of esophageal leiomyoma. TREATMENT AND OUTCOME In view of numerous possible complications associated with esophageal surgery, the decision was made to palliatively treat the dog by transcardial placement of a self-expanding, covered, nitinol esophageal stent under endoscopic guidance. Two weeks after stent placement, radiography revealed complete migration of the stent into the gastric lumen. Gastrotomy was performed, and the stent was replaced and fixed in place. Twenty-four months after initial stent placement, the dog had a healthy body condition and remained free of previous clinical signs. CLINICAL RELEVANCE Diffuse benign muscular neoplasia should be considered as a differential diagnosis for acquired esophageal dilatation in adult and elderly dogs. In the dog of this report, transcardial stent placement resulted in resolution of the clinical signs, with no apparent adverse effect on digestive function. The described procedure could be beneficial for nonsurgical treatment of benign esophageal tumors in dogs.

Stent migration following endoscopic suture fixation of esophageal self-expandable metal stents: a systematic review and meta-analysis.

PubMed

Law, Ryan; Prabhu, Anoop; Fujii-Lau, Larissa; Shannon, Carol; Singh, Siddharth

2018-02-01

Covered self-expandable metal stents (SEMS) are utilized for the management of benign and malignant esophageal conditions; however, covered SEMS are prone to migration. Endoscopic suture fixation may mitigate the migration risk of covered esophageal SEMS. Hence, we conducted a systematic review and meta-analysis to evaluate the effectiveness and safety of endoscopic suture fixation for covered esophageal SEMS. Following PRISMA guidelines, we performed a systematic review from 2011 to 2016 to identify studies (case control/case series) reporting the technical success and migration rate of covered esophageal SEMS following endoscopic suture fixation. We searched multiple electronic databases and conference proceedings. We calculated pooled rates (and 95% confidence intervals [CI]) of technical success and stent migration using a random effects model. We identified 14 studies (212 patients) describing covered esophageal SEMS placement with endoscopic suture fixation. When reported, SEMS indications included leak/fistula (n = 75), stricture (n = 65), perforation (n = 10), and achalasia (n = 4). The pooled technical success rate was 96.7% (95% CI 92.3-98.6), without heterogeneity (I 2  = 0%). We identified 29 SEMS migrations at rate of 15.9% (95% CI 11.4-21.6), without heterogeneity (I 2  = 0%). Publication bias was observed, and using the trim-and-fill method, a more conservative estimate for stent migration was 17.0%. Suture-related adverse events were estimated to occur in 3.7% (95% CI 1.6-8.2) of cases. Endoscopic suture fixation of covered esophageal SEMS appears to reduce stent migration when compared to published rates of non-anchored SEMS. However, SEMS migration still occurs in approximately 1 out of 6 cases despite excellent immediate technical success and low risk of suture-related adverse events.

External carotid artery stenosis after internal and common carotid stenting.

PubMed

Siracuse, Jeffrey J; Epelboym, Irene; Li, Boyangzi; Hoque, Rahima; Catz, Diana; Morrissey, Nicholas J

2015-04-01

The external carotid artery (ECA) can be an important collateral for cerebral perfusion in the presence of severe internal carotid artery (ICA) disease. ICA stenting that covers the ECA origin may put the ECA at increased risk of stenosis. Our objective was to determine the rate of ECA stenosis secondary to ICA stenting, determine predictive factors, and describe any subsequent associated symptoms. We retrospectively reviewed clinical data on all ICA stents crossing the origin of the ECA placed by vascular surgeons at our institution. We analyzed patient demographics, comorbidities, stent type and sizes, as well as medication profile to determine predictors of ECA stenosis. Between 2005 and 2013, there were 72 (out of 119 total ICA stenting) patients (mean age 71, 68% male) who underwent placement of ICA stents that also crossed the origin of the ECA. Six patients (8.3%) had a significantly increased ECA stenosis postprocedure. There were no occlusions. All patients with ECA stenosis maintained patency of their ICA stent and were asymptomatic. Age, gender, comorbidities, stent type and size, and medication profile were not associated with ECA stenosis after stenting. ECA stenosis after ICA stenting covering the ECA origin is uncommon and not clinically significant in patients with patent ICA stents. The clinical significance of concurrent ECA and ICA stenosis after stenting is unclear as it is not captured here. The potential for ECA stenosis should not deter stenting across the ECA origin if necessary. Patient and stent factors are not predictive of ECA stenosis. Copyright © 2015 Elsevier Inc. All rights reserved.

Endoscopic stenting for benign upper gastrointestinal strictures and leaks.

PubMed

Sharaiha, Reem Z; Kim, Katherine J; Singh, Vikesh K; Lennon, Anne Marie; Amateau, Stuart K; Shin, Eun Ji; Canto, Marcia Irene; Kalloo, Anthony N; Khashab, Mouen A

2014-01-01

Self-expandable metal stents (SEMS) and self-expandable plastic stents (SEPS) maybe used for the treatment of benign upper gastrointestinal (GI) leaks and strictures. This study reviewed our experience with stent insertions in patients with benign upper GI conditions. Patients who underwent stent placement for benign upper GI strictures and leaks between March 2007 and April 2011 at a tertiary referral academic center were studied using an endoscopic database and electronic patient records. The technical success, complications, and clinical improvement after stent removal were compared according to type of stent. The outcomes measured were clinical response, adverse events, and predictors of stent migration. Thirty-eight patients (50 % male, mean age = 54 years, range = 12-82) underwent 121 endoscopic procedures. Twenty patients had stents placed for strictures, and 18 had stents placed for leaks. Stent placement was technically successful in all patients. The average duration of stent placement was 54 days (range = 18-118). Clinical improvement immediately after stent placement was seen in 29 of the 38 patients (76.3 %). Immediate post-procedure adverse events occurred in 8 patients. Late adverse events were seen in 18 patients. Evidence of stent migration occurred in 16 patients and was seen in 42 of the 118 successfully placed stents (35.5 %). Migration was more frequent with fully covered SEMS (p = 0.002). After stent removal, 27 patients were evaluable for long-term success (median follow-up time of 283 days, IQR 38-762). Resolution of strictures or leaks was seen in 11 patients (40.7 %). Predictors for long-term success included increasing age and if the stent did not cross the GE junction. Placement of SEPS and SEMS for benign refractory strictures and fistulas has modest long-term clinical efficacy and is limited by a significant migration rate. Stent migration is common and frequent with fully covered SEMS compared to other types of stents, regardless of

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.

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

Fully vs. partially covered selfexpandable metal stent for palliation of malignant esophageal strictures: a randomized trial (the COPAC study).

PubMed

Didden, Paul; Reijm, Agnes N; Erler, Nicole S; Wolters, Leonieke M M; Tang, Thjon J; Ter Borg, Pieter C J; Leeuwenburgh, Ivonne; Bruno, Marco J; Spaander, Manon C W

2018-06-12

 Covered esophageal self-expandable metal stents (SEMSs) are currently used for palliation of malignant dysphagia. The optimal extent of the covering to prevent recurrent obstruction is unknown. Therefore, we aimed to compare fully covered (FC) versus partially covered (PC) SEMSs in patients with incurable malignant esophageal stenosis.  In this multicenter randomized controlled trial, 98 incurable patients with dysphagia caused by a malignant stricture of the esophagus or cardia were randomized 1:1 to an FC-SEMS or PC-SEMS. The primary outcome was recurrent obstruction after endoscopic SEMS placement. Secondary outcomes were technical and clinical success, adverse events, and health-related quality of life (HRQoL). Patients were followed until 6 months after SEMS placement or to SEMS removal, second SEMS insertion, or death, whichever came first.  Recurrent obstruction after SEMS placement was similar for both types of stents: 19 % for FC-SEMSs and 22 % for PC-SEMSs ( P  = 0.65). The times to recurrent obstruction did not differ. The frequency of adverse events was similar between the two groups, with major adverse events occurring in 38 % and 47 % of patients for FC-SEMSs and PC-SEMSs, respectively ( P  = 0.34). No significant differences were seen in technical success, improvement of dysphagia, and HRQoL. Proximal esophageal stenosis and female sex were independently associated with recurrent obstruction and/or major adverse events.  Esophageal FC-SEMSs did not reveal a lower recurrent obstruction rate compared with PC-SEMSs in the palliative management of malignant dysphagia. © Georg Thieme Verlag KG Stuttgart · New York.

Enhancing Stent Effectiveness with Nanofeatures

PubMed Central

Bassous, Nicole; Cooke, John P.; Webster, Thomas J.

2016-01-01

Drug-eluting stents are an effective therapy for symptomatic arterial obstructions, substantially reducing the incidence of restenosis by suppressing the migration and proliferation of vascular smooth muscle cells into the intima. However, current drug-eluting stents also inhibit the growth of endothelial cells, which are required to cover the vascular stent to reduce an excessive inflammatory response. As a result, the endothelial lining of the lumen is not regenerated. Since the loss of this homeostatic monolayer increases the risk of thrombosis, patients with drug-eluting stents require long-term antithrombotic therapy. Thus, there is a need for improved devices with enhanced effectiveness and physiological compatibility towards endothelial cells. Current developments in nanomaterials may enhance the function of commercially available vascular devices. In particular, modified design schemes might incorporate nanopatterns or nanoparticle-eluting features that reduce restenosis and enhance re-endothelialization. The intent of this review is to discuss emerging nanotechnologies that will improve the performance of vascular stents. PMID:27826371

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.

Feasibility of using bulk metallic glass for self-expandable stent applications.

PubMed

Praveen Kumar, Gideon; Jafary-Zadeh, Mehdi; Tavakoli, Rouhollah; Cui, Fangsen

2017-10-01

Self-expandable stents are widely used to restore blood flow in a diseased artery segment by keeping the artery open after angioplasty. Despite the prevalent use of conventional crystalline metallic alloys, for example, nitinol, to construct self-expandable stents, new biomaterials such as bulk metallic glasses (BMGs) are being actively pursued to improve stent performance. Here, we conducted a series of analyses including finite element analysis and molecular dynamics simulations to investigate the feasibility of using a prototypical Zr-based BMG for self-expandable stent applications. We model stent crimping of several designs for different percutaneous applications. Our results indicate that BMG-based stents with diamond-shaped crowns suffer from severe localization of plastic deformation and abrupt failure during crimping. As a possible solution, we further illustrate that such abrupt failure could be avoided in BMG-based stents without diamond shape crowns. This work would open a new horizon for a quest toward exploiting superior mechanical and functional properties of metallic glasses to design future stents. © 2016 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 105B: 1874-1882, 2017. © 2016 Wiley Periodicals, Inc.

Stent placement for benign colonic stenosis: case report, review of the literature, and animal pilot data.

PubMed

Geiger, Timothy M; Miedema, Brent W; Tsereteli, Zurab; Sporn, Emanuel; Thaler, Klaus

2008-10-01

Permanent metal stent placement for malignant intestinal obstruction has been proven to be efficient. Temporary stents for benign conditions of the colon and rectum are less studied. This is a case study, review of the literature, and observation from an animal model on placement of stents in the colorectum for benign disease. A 55-year-old man presented with recurrent obstructions from a benign stricture of the distal sigmoid colon. After failed balloon dilations, a polyester coated stent was placed. The purpose of the stent was to improve symptoms and avoid surgery. The stent was expelled after 5 days. We conducted a literature review of stents placed for benign colorectal strictures and an animal study to evaluate stent migration. In the literature, there were 53 reports of uncovered metal stents, four covered metal stents, and six polyester stents. Patency rates were 71%, and migration rate was 43%. Migration occurred earlier with polyester stents (mean=8 days) versus covered (32 days) or uncovered metal stents (112 days). Severe complications were seen in 23% of patients. Four 45-kg pigs underwent rectosigmoid transection with a 21-mm anastomosis and endoscopic placement of a Polyflex stent. Two stents were secured with suture. Stents without fixation were expelled within 24 h of surgery. Stents with fixation were expelled between postoperative days 2 and 14. Stents for the treatment of benign colorectal strictures are safe, with comparable patency rates between stent types. Metal stents can cause severe complications. In a pig model, covered polyester stents tend to migrate early even with fixation. Further investigation needs to focus on new stent designs and/or better fixation.

Gianturco-Rösch Z stents in tracheobronchial stenoses.

PubMed

Petersen, B D; Uchida, B T; Barton, R E; Keller, F S; Rösch, J

1995-01-01

To evaluate expandable metallic Gianturco-Rösch Z (GRZ) stents for treatment of benign and malignant tracheobronchial stenoses. Six patients, ages 45-73 years, were treated for severe dyspnea with placement of GRZ stents. Three patients had benign tracheal lesions (one tracheomalacia, two postoperative) and received uncovered GRZ stents. Three patients had malignant stenoses at the level of the carina; one received an uncovered stent and the other two received silicone-covered GRZ stents. Two patients with benign lesions responded well to stent placement. One was asymptomatic for a year and then was lost to follow-up; the other improved substantially but died of end-stage lung disease 5 months after stent placement. A third patient with a benign high tracheal lesion did poorly; symptoms recurred secondary to inferior migration of a stent, which was removed surgically at 4 months. All patients with malignant lesions improved symptomatically after stent placement and remained without significant dyspnea until death (from 1 to 6 months). Expandable GRZ stents are promising devices for treatment of benign lesions and offer effective palliation of malignant tracheobronchial stenoses.

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.

[Evaluation of stents in treating childhood benign esophageal strictures].

PubMed

Reinshagen, K; Kähler, G; Manegold, B C; Waag, K-L

2009-01-01

Esophageal stenting is a popular of treatment of esophageal strictures in adults. It has also been described for children with benign strictures who did not respond to standard dilatation therapy. The aim of the study was to evaluate weather esophageal stents could be used safely and effectively in the treatment of benign esophageal strictures in children. From 1993 to 2005 stenting therapy was performed in 12 children with complicated esophageal strictures. Etiologies of the strictures were caustic burns in 9 patients, postoperative strictures due to complicated esophageal atresia in 2 patients and iatrogenic esophageal injury in 1 patient. Esophageal silicon tubi, covered retrievable expandable nitinol and plastic stents were placed endoscopically. The clinical course and the long term follow up were evaluated retrospectively The stents and tubi were placed in all patients without complications and were later removed successfully. 6 patients were treated with a self expanding plastic stent. The plastic stents showed a distinct tendency to migrate but in 5/6 patients esophageal stricture was treated successfully. 3 patients were treated by a covered self expanding nitinol stent. No migration occurred. One patient was asymptomatic after therapy, one required further dilatation therapy and the third had esophageal resection. 3 patients were treated by esophageal tubi. 2 patients required surgery in the follow up, one patient is asymptomatic. The use of stenting devices in children to treat benign esophageal strictures is safe and efficient. The self expanding plastic stents had the best long term results but required high compliance of parents and children due to the tendency of stent migration. Self expanding nitinol stents are more traumatic at the extraction procedure and are useful in patients with low compliance. Recurrence of strictures occurred most often after esophageal tubi possibly due to the lack of radial expansion.

A new fully covered metal stent with anti-migration features for the treatment of malignant dysphagia.

PubMed

Walter, Daisy; van den Berg, Maarten W; van Hooft, Jeanin E; Boot, Henk; Scheffer, Robert C H; Vleggaar, Frank P; Siersema, Peter D

2014-12-01

A new esophageal stent with two anti-migration features was developed to minimize migration. The aim of this study was to evaluate the clinical efficacy and safety of this stent in patients with malignant dysphagia. A total of 40 patients with dysphagia due to a malignant obstruction of the esophagus were prospectively enrolled in this cohort study. Stent placement was technically successful in 39 patients (98 %). The median dysphagia-free time after stent placement was 220 days (95 % confidence interval 94 - 345 days). Nine patients (23 %) experienced recurrent dysphagia due to tissue overgrowth (n = 2), stent fracture (n = 1), and partial (n = 5) or complete (n = 1) stent migration. A total of 16 serious adverse events occurred in 14 patients (36 %), with hemorrhage (n = 3) and severe nausea or vomiting (n = 3) being the most common causes. This new stent design was effective for the palliation of malignant dysphagia and had a low rate of recurrent dysphagia. However, despite the anti-migration features, stent migration was still a major cause of recurrent dysphagia. Furthermore, treatment was associated with a high adverse event rate. Dutch Trial Registration (NTR 3313). © Georg Thieme Verlag KG Stuttgart · New York.

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

[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.

Feasibility and safety of placement of a newly designed, fully covered self-expandable metal stent for refractory benign pancreatic ductal strictures: a pilot study (with video).

PubMed

Park, Do Hyun; Kim, Myung-Hwan; Moon, Sung-Hoon; Lee, Sang Soo; Seo, Dong-Wan; Lee, Sung-Koo

2008-12-01

Painful chronic pancreatitis with main pancreatic ductal strictures is usually managed with endotherapy with a plastic stent. To date, the role of placement of metallic stents, especially uncovered ones in benign pancreatic ductal stricture, has been unsatisfactory as a result of stent dysfunction related to mucosal hyperplasia. We explored the feasibility and safety of temporary placement of a newly designed, fully covered self-expandable metal stent (FCSEMS) in painful chronic pancreatitis and refractory benign pancreatic ductal strictures. A prospective pilot and feasibility study. A tertiary academic center. Thirteen patients with chronic painful pancreatitis of alcoholic (8) or idiopathic (5) etiology. ERCP with temporary FCSEMS placement (2 months). Endoscopic removal of FCSEMSs was performed with a snare or rat-tooth forceps. End points were feasibility, safety, and morbidity. Successful FCSEMS placement was performed in all enrolled patients. After immediate placement of FCSEMS, 2 patients had mild acute pancreatitis related mainly to the stricture dilation procedure (Soehendra stent retriever or balloon dilation). Complications associated with stent placement included 5 migrations (39%, 1 proximal and 4 distal) and 2 incidents of cholestatic liver dysfunction associated with the compression of the bile duct orifice by expansion of FCSEMSs. In 1 patient with proximal migration, the stent was repositioned by an inflated retrieval balloon. Additional endoscopic biliary sphincterotomy with or without biliary stenting was performed in 2 patients with cholestatic liver dysfunction. There was no occurrence of pancreatic sepsis among any patients. FCSEMSs were removed from 9 of 9 patients without stent migration (100% [9/9] as per protocol, and 69% [9/13] as intention to treat, respectively). Improvement or resolution of the pancreatic ductal strictures was confirmed in all 13 patients on follow-up ERCP (2 months after stent placement), regardless of stent

Hemodynamic comparison of stent configurations used for aortoiliac occlusive disease.

PubMed

Groot Jebbink, Erik; Mathai, Varghese; Boersen, Johannes T; Sun, Chao; Slump, Cornelis H; Goverde, Peter C J M; Versluis, Michel; Reijnen, Michel M P J

2017-07-01

Endovascular treatment of aortoiliac occlusive disease entails the use of multiple stents to reconstruct the aortic bifurcation. Different configurations have been applied and geometric variations exist, as quantified in previous work. Other studies concluded that specific stent geometry seems to affect patency. These variations may affect local flow patterns, resulting in different wall shear stress (WSS) and oscillating shear index (OSI). The aim of this study was to compare the effect of different stent configurations on flow perturbations (recirculation and fluid stasis), WSS, and OSI in an in vitro setup. Three different stent configurations were deployed in transparent silicone models: bare-metal kissing (BMK) stents, covered kissing (CK) stents, and the covered endovascular reconstruction of the aortic bifurcation (CERAB) configuration. Transparent covered stents were created with polyurethane to enable visualization. Models were placed in a circulation setup under physiologic flow conditions. Time-resolved laser particle image velocimetry techniques were used to quantify the flow, and WSS and OSI were calculated. The BMK configuration did not show flow disturbances at the inflow section, and WSS values were similar to the control. An area of persistent low flow was observed throughout the cardiac cycle in the area between the anatomic bifurcation and neobifurcation. The CK model showed recirculation zones near the inflow area of the stents with a resulting low average WSS value and high OSI. The proximal inflow of the CERAB configuration did not show flow disturbances, and WSS values were comparable to control. Near the inflow of the limbs, a minor zone of recirculation was observed without changes in WSS values. Flow, WSS, and OSI on the lateral wall of the proximal iliac artery were undisturbed in all models. The studied aortoiliac stent configurations have distinct locations where flow disturbances occur, and these are related to the radial mismatch

A novel, ring-connected stent versus conventional GI stents: comparative study of physical properties and migration rates in a canine colon obstruction model.

PubMed

Park, Hong Suk; Choo, In Wook; Seo, Soowon; Hyun, Dongho; Lim, Sooyoun; Kim, Jae J; Hong, Saet-Byul; Min, Byung-Hoon; Do, Young Soo; Choo, Sung Wook; Shin, Sung Wook; Park, Kwang Bo; Cho, Sung Ki

2015-01-01

Migration of stents is one of the most common adverse events in covered stent placement in GI tract obstruction. To compare physical property and migration rates in a canine colon obstruction model among a novel stent and conventional stents. Comparative physical test and animal study. Medical device testing laboratory and animal laboratory. Mongrel dogs (N=26). Surgical colon obstruction followed by placement of a novel (n=13) or conventional (n=13) stent. Physical properties, migration, and adverse events. The novel stent showed better flexibility, as in a physical test of longitudinal compressibility and axial force, than did conventional stents, and it withstood the fatigue test for 10 days. In terms of radial force and tensile strength, the novel stent showed the same or better results than conventional stents. In a canine colon obstruction model, the migration rate of a novel stent was significantly lower than that of a conventional stent (2/13, 15.4% vs 8/13, 61.5%; P=.008). Animal study of limited size. The novel, ring-connected stent is more flexible and more resistant to migration than the conventional stents. Copyright © 2015 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

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.

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

[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.

Gastric ulceration following oesophageal stent migration complicating surgical management of oesophageal cancer

PubMed Central

Markar, Sheraz R.; Ross, Andrew; Low, Donald E.

2012-01-01

Oesophageal, fully covered self-expanding metal stents (SEMS) allow palliation of dysphagia so as to support nutrition during neoadjuvant therapy. We present a 68-year old man with an oesophageal adenocarcinoma (T3N1M0) who had a fully covered oesophageal SEMS placed prior to neoadjuvant chemoradiotherapy. Repeat endoscopy 8 weeks later (for stent removal) showed that the stent had migrated and impacted upon the greater curvature of the stomach with a resultant ulcer. Surgery was delayed and, 10 weeks following the cessation of neoadjuvant chemoradiotherapy, this patient underwent a right thoracoabdominal oesophagogastrectomy. Operative findings included an erosion of the stent-induced gastric ulcer into the body of the pancreas and showed that the ulcerated tumour had become adherent to the thoracic aorta. This report demonstrates that the complications of stent migration can significantly impact upon surgical resection at multiple levels and provides a case for the routine removal of stents used in the neoadjuvant setting. PMID:22593562

Management of benign dynamic "A-shape" tracheal stenosis: a retrospective study of 60 patients.

PubMed

Plojoux, Jérôme; Laroumagne, Sophie; Vandemoortele, Thomas; Astoul, Philippe J; Thomas, Pascal A; Dutau, Hervé

2015-02-01

Benign tracheal stenosis complicates tracheal intubation or tracheostomy in 0.6% to 65% of cases. Surgical resection is the standard treatment. Endoscopic management is used for inoperable patients with 17% to 69% success. Dynamic "A-shape" tracheal stenosis (DATS) results in a dynamic stenosis with anterior fracture of tracheal cartilage and frequently associated posterior malacia. We report the results of our multidisciplinary management. Sixty patients with DATS were included. Management decision was made during initial bronchoscopy. When suitable, patients were referred to thoracic surgery for tracheal resection. Posterior localized tracheomalacia was treated with laser photocoagulation of the posterior tracheal wall. Tracheal stents were placed if the stenosis persisted after laser treatment. The choice of stent (straight silicone, hour-glass shaped silicone, T-tube, or fully-covered self-expandable metallic stent) was based on operator's judgment. After 12 to 18 months, stents were removed. If the stenosis persisted after stent removal, surgery was reconsidered. If surgery was not possible, a stent was replaced. In case of satisfactory result, a stent was replaced only after recurrence. Stable patients after treatment were considered as success, requirement of long-term tracheostomy or T tube as failure, and long-term stent as partial success. All patients developed DATS after tracheostomy. Thirty-three patients had posterior tracheomalacia. In 13 patients, mild stenosis required only endoscopic surveillance. Two patients were referred to thoracic surgery for tracheal resection surgery. Endoscopic management was the initial therapy in 45 patients (75%) and was considered successful in 23 patients (51%), partially successful in 10 (22%), and failed in 12 (27%). Five patients with successful outcomes required only laser therapy. Overall 70 stents were placed in 35 patients, with a migration rate of 31%. The DATS management was successful in 63%. Stent migration

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.

Angiographic analysis of animal model aneurysms treated with novel polyurethane asymmetric vascular stent (P-AVS): feasibility study.

PubMed

Ionita, Ciprian N; Dohatcu, Andreea; Sinelnikov, Andrey; Sherman, Jason; Keleshis, Christos; Paciorek, Ann M; Hoffmann, K R; Bednarek, D R; Rudin, S

2009-01-01

Image-guided endovascular intervention (EIGI), using new flow modifying endovascular devices for intracranial aneurysm treatment is an active area of stroke research. The new polyurethane-asymmetric vascular stent (P-AVS), a vascular stent partially covered with a polyurethane-based patch, is used to cover the aneurysm neck, thus occluding flow into the aneurysm. This study involves angiographic imaging of partially covered aneurysm orifices. This particular situation could occur when the vascular geometry does not allow full aneurysm coverage. Four standard in-vivo rabbit-model aneurysms were investigated; two had stent patches placed over the distal region of the aneurysm orifice while the other two had stent patches placed over the proximal region of the aneurysm orifice. Angiographic analysis was used to evaluate aneurysm blood flow before and immediately after stenting and at four-week follow-up. The treatment results were also evaluated using histology on the aneurysm dome and electron microscopy on the aneurysm neck. Post-stenting angiographic flow analysis revealed aneurysmal flow reduction in all cases with faster flow in the distally-covered case and very slow flow and prolonged pooling for proximal-coverage. At follow-up, proximally-covered aneurysms showed full dome occlusion. The electron microscopy showed a remnant neck in both distally-placed stent cases but complete coverage in the proximally-placed stent cases. Thus, direct flow (impingement jet) removal from the aneurysm dome, as indicated by angiograms in the proximally-covered case, was sufficient to cause full aneurysm healing in four weeks; however, aneurysm healing was not complete for the distally-covered case. These results support further investigations into the treatment of aneurysms by flow-modification using partial aneurysm-orifice coverage.

Angiographic analysis of animal model aneurysms treated with novel polyurethane asymmetric vascular stent (P-AVS): feasibility study

PubMed Central

Ionita, Ciprian N.; Dohatcu, Andreea; Sinelnikov, Andrey; Sherman, Jason; Keleshis, Christos; Paciorek, Ann M.; Hoffmann, K R.; Bednarek, D. R.; Rudin, S

2009-01-01

Image-guided endovascular intervention (EIGI), using new flow modifying endovascular devices for intracranial aneurysm treatment is an active area of stroke research. The new polyurethane-asymmetric vascular stent (P-AVS), a vascular stent partially covered with a polyurethane-based patch, is used to cover the aneurysm neck, thus occluding flow into the aneurysm. This study involves angiographic imaging of partially covered aneurysm orifices. This particular situation could occur when the vascular geometry does not allow full aneurysm coverage. Four standard in-vivo rabbit-model aneurysms were investigated; two had stent patches placed over the distal region of the aneurysm orifice while the other two had stent patches placed over the proximal region of the aneurysm orifice. Angiographic analysis was used to evaluate aneurysm blood flow before and immediately after stenting and at four-week follow-up. The treatment results were also evaluated using histology on the aneurysm dome and electron microscopy on the aneurysm neck. Post-stenting angiographic flow analysis revealed aneurysmal flow reduction in all cases with faster flow in the distally-covered case and very slow flow and prolonged pooling for proximal-coverage. At follow-up, proximally-covered aneurysms showed full dome occlusion. The electron microscopy showed a remnant neck in both distally-placed stent cases but complete coverage in the proximally-placed stent cases. Thus, direct flow (impingement jet) removal from the aneurysm dome, as indicated by angiograms in the proximally-covered case, was sufficient to cause full aneurysm healing in four weeks; however, aneurysm healing was not complete for the distally-covered case. These results support further investigations into the treatment of aneurysms by flow-modification using partial aneurysm-orifice coverage. PMID:19763252

Very late stent thrombosis and late target lesion revascularization after sirolimus-eluting stent implantation: five-year outcome of the j-Cypher Registry.

PubMed

Kimura, Takeshi; Morimoto, Takeshi; Nakagawa, Yoshihisa; Kawai, Kazuya; Miyazaki, Shunichi; Muramatsu, Toshiya; Shiode, Nobuo; Namura, Masanobu; Sone, Takahito; Oshima, Shigeru; Nishikawa, Hideo; Hiasa, Yoshikazu; Hayashi, Yasuhiko; Nobuyoshi, Masakiyo; Mitudo, Kazuaki

2012-01-31

There is a scarcity of long-term data from large-scale drug-eluting stent registries with a large enough sample to evaluate low-frequency events such as stent thrombosis (ST). Five-year outcomes were evaluated in 12 812 consecutive patients undergoing sirolimus-eluting stent (SES) implantation in the j-Cypher registry. Cumulative incidence of definite ST was low (30 day, 0.3%; 1 year, 0.6%; and 5 years, 1.6%). However, late and very late ST continued to occur without attenuation up to 5 years after sirolimus-eluting stent implantation (0.26%/y). Cumulative incidence of target lesion revascularization within the first year was low (7.3%). However, late target lesion revascularization beyond 1 year also continued to occur without attenuation up to 5 years (2.2%/y). Independent risk factors of ST were completely different according to the timing of ST onset, suggesting the presence of different pathophysiological mechanisms of ST according to the timing of ST onset: acute coronary syndrome and target of proximal left anterior descending coronary artery for early ST; side-branch stenting, diabetes mellitus, and end-stage renal disease with or without hemodialysis for late ST; and current smoking and total stent length >28 mm for very late ST. Independent risk factors of late target lesion revascularization beyond 1 year were generally similar to those risk factors identified for early target lesion revascularization. Late adverse events such as very late ST and late target lesion revascularization are continuous hazards, lasting at least up to 5 years after implantation of the first-generation drug-eluting stents (sirolimus-eluting stents), which should be the targets for developing improved coronary stents.

Stent-based nitric oxide delivery reducing neointimal proliferation in a porcine carotid overstretch injury model.

PubMed

Hou, Dongming; Narciso, Hugh; Kamdar, Kirti; Zhang, Ping; Barclay, Bruce; March, Keith L

2005-01-01

The effects of nitric acid (NO) on vessel response to injury include the inhibition of platelet adhesion, platelet aggregation, leukocyte adhesion and smooth muscle cell proliferation. Releasing NO from a stent might reduce the clinical problem of restenosis. The present study was designed to examine whether an NO-eluting covered stent can prevent neointimal formation in a porcine carotid overstretch injury model. The interior of a self-expanding polytetrafluoroethylene (ePTFE)-covered aSpire stent was coated with silicone, which contained 23.6 microg or 54.5 microg sodium nitroprusside (SNP, NO-releasing compound). The stent was implanted into carotid artery. Six pigs were implanted with stents, one high-dose SNP and one uncoated control, following balloon overstretch injury of the carotid artery with a balloon-to-artery ratio of 1.3:1. No local or systemic toxicity was evidenced in the six pigs after carotid artery implantation with either low- or high-dose stents within a week. At day 28, the mean intimal thickness was 0.12 +/- 0.05 mm for NO-eluting stents and 0.43 +/- 0.09 mm for uncoated stents (p = 0.008). The mean neointimal area was reduced from 2.40 +/- 0.39 mm2 for control stents to 0.49 +/- 0.16 mm2 for NO-eluting stents (p < 0.0001), which resulted in a 24% reduction of angiographic vessel narrowing. The NO-eluting ePTFE-covered stent is feasible and effectively reduces in-stent neointimal hyperplasia at 28 days in a porcine carotid overstretch model.

Association between silent embolic cerebral infarction and continuous increase of P2Y12 reaction units after neurovascular stenting.

PubMed

Kim, Bum Joon; Kwon, Joo Y; Jung, Jin-Man; Lee, Deok Hee; Kang, Dong-Wha; Kim, Jong S; Kwon, Sun U

2014-10-01

Endovascular procedures are one of the important treatment options for steno-occlusive arteries in ischemic stroke patients. However, embolic complications after such procedures are always a concern. The authors investigated the association between serial change of residual platelet reactivity and silent embolic cerebral infarction (SECI) after endovascular treatment. Ischemic stroke patients undergoing stenting of intra- or extracranial arteries were recruited prospectively. Residual platelet reactivity, represented by aspirin reaction units (ARUs) and P2Y12 reaction units (PRUs), was measured serially (6 hours before, immediately after, and 24 hours after the procedure). A loading dosage of aspirin (500 mg) and/or clopidogrel (300 mg) was given 24 hours before the procedure to patients naïve to antiplatelet agents, whereas the usual dosage (aspirin 100 mg and clopidogrel 75 mg) was continued for patients who had previously been taking these agents for more than a week. Diffusion-weighted MRI was performed before and 24 hours after the procedure to detect new SECIs. Clinical characteristics, baseline ARU and PRU values, and the change in ARU and PRU values after stenting were compared between patients with and without SECIs. Among 69 consecutive patients who underwent neurovascular stent insertion, 41 patients (59.4%) had poststenting SECIs. The lesion was located only at the vascular territory of the stented vessel in 21 patients (51.2%), outside the stented vessel territory in 8 patients (19.5%), and both inside and outside in 12 patients (29.3%). The occurrence of SECIs was not associated with the baseline ARU or PRU value, but was associated with PRU increase after stenting (36 ± 73 vs -12 ± 59, p = 0.007), deployment of a longer stent (31.1 ± 16.5 mm vs 21.8 ± 9.9 mm, p = 0.01), and stent insertion in extracranial arteries (78.1% vs 45.2%, p = 0.008). Stent length (OR 1.066, p = 0.01) and PRU change (OR 1.009, p = 0.04) were independently associated with

Safety of endoscopic removal of self-expandable stents after treatment of benign esophageal diseases.

PubMed

van Halsema, Emo E; Wong Kee Song, Louis M; Baron, Todd H; Siersema, Peter D; Vleggaar, Frank P; Ginsberg, Gregory G; Shah, Pari M; Fleischer, David E; Ratuapli, Shiva K; Fockens, Paul; Dijkgraaf, Marcel G W; Rando, Giacomo; Repici, Alessandro; van Hooft, Jeanin E

2013-01-01

Temporary placement of self-expandable stents has been increasingly used for the management of benign esophageal diseases. To evaluate the safety of endoscopic removal of esophageal self-expandable stents placed for the treatment of benign esophageal diseases. Multicenter retrospective study. Six tertiary care centers in the United States and Europe. A total of 214 patients with benign esophageal diseases undergoing endoscopic stent removal. Endoscopic stent removal. Endoscopic techniques for stent removal, time to stent removal, and adverse events related to stent removal. A total of 214 patients underwent a total of 329 stent extractions. Stents were mainly placed for refractory strictures (49.2%) and fistulae (49.8%). Of the removed stents, 52% were fully covered self-expandable metal stents (FCSEMSs), 28.6% were partially covered self-expandable metal stents (PCSEMSs), and 19.5% were self-expandable plastic stents. A total of 35 (10.6%) procedure-related adverse events were reported, including 7 (2.1%) major adverse events. Multivariate analysis revealed that use of PCSEMSs (P < .001) was a risk factor for adverse events during stent removal. Favorable factors for successful stent removal were FCSEMSs (P ≤ .012) and stent migration (P = .010). No significant associations were found for stent indwelling time (P = .145) and stent embedding (P = .194). Retrospective analysis, only tertiary care centers. With an acceptable major adverse event rate of 2.1%, esophageal stent removal in the setting of benign disease was found to be a safe and feasible procedure. FCSEMSs were more successfully removed than self-expandable plastic stents and PCSEMSs. Adverse events caused by stent removal were not time dependent. Copyright © 2013 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

Multidetector-Row Computed Tomography in the Evaluation of Transjugular Intrahepatic Portosystemic Shunt Performed with Expanded-Polytetrafluoroethylene-Covered Stent-Graft

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

Fanelli, Fabrizio, E-mail: fabrizio.fanelli@uniroma1.it; Bezzi, Mario; Bruni, Antonio

2011-02-15

We assessed, in a prospective study, the efficacy of multidetector spiral computed tomography (MDCT) in the evaluation of transjugular intrahepatic portosystemic shunt (TIPS) patency in patients treated with the Viatorr (Gore, Flagstaff, AZ) expanded-polytetrafluoroethylene (e-PTFE)-covered stent-graft. Eighty patients who underwent TIPS procedure using the Viatorr self-expanding e-PTFE stent-graft were evaluated at follow-up of 1, 3, 6, and 12 months with clinical and laboratory tests as well as ultrasound-color Doppler (USCD) imaging. In case of varices, upper gastrointestinal endoscopy was also performed. In addition, the shunt was evaluated using MDCT at 6 and 12 months. In all cases of abnormal findingsmore » and discrepancy between MDCT and USCD, invasive control venography was performed. MDCT images were acquired before and after injection of intravenous contrast media on the axial plane and after three-dimensional reconstruction using different algorithms. MDCT was successfully performed in all patients. No artefacts correlated to the Viatorr stent-graft were observed. A missing correlation between UCSD and MDCT was noticed in 20 of 80 (25%) patients. Invasive control venography confirmed shunt patency in 16 (80%) cases and shunt malfunction in 4 (20%) cases. According to these data, MDCT sensitivity was 95.2%; specificity was 96.6%; and positive (PPV) and negative predictive values (NPV) were 90.9 and 98.2%, respectively. USCD sensitivity was 90%; specificity was 75%; and PPV and NPV were 54.5 and 95.7%, respectively. A high correlation (K value = 0.85) between MDCT and invasive control venography was observed. On the basis of these results, MDCT shows superior sensitivity and specificity compared with USCD in those patients in whom TIPS was performed with the Viatorr stent-graft. MDCT can be considered a valid tool in the follow-up of these patients.« less

Modified fully covered self-expandable metal stents with antimigration features for benign pancreatic-duct strictures in advanced chronic pancreatitis, with a focus on the safety profile and reducing migration.

PubMed

Moon, Sung-Hoon; Kim, Myung-Hwan; Park, Do Hyun; Song, Tae Joon; Eum, Junbum; Lee, Sang Soo; Seo, Dong Wan; Lee, Sung Koo

2010-07-01

Fully covered self-expandable metal stent (FCSEMS) placement has recently been tried in the management of refractory pancreatic-duct strictures associated with advanced chronic pancreatitis. The major limitation of FCSEMSs was frequent migration. To assess the safety, migration rate, and removability of modified FCSEMSs with antimigration features used for the treatment of benign pancreatic-duct strictures. Prospective study. Tertiary academic center. Thirty-two patients with chronic painful pancreatitis and dominant ductal stricture. Transpapillary endoscopic placement of FCSEMSs in the pancreatic duct with removal after 3 months. Technical and functional success and adverse events associated with the placement of metal stents. FCSEMSs were successfully placed in all patients through the major (n = 27) or minor (n = 5) duodenal papilla. All patients achieved pain relief from stent placement. There was no occurrence of stent-induced pancreatitis or pancreatic sepsis. No stent migrated, and all stents were easily removed. Follow-up ERCP 3 months after stent placement showed resolution of duct strictures in all patients. Pancreatograms obtained at FCSEMS removal displayed de novo focal pancreatic duct strictures in 5 patients, but all were asymptomatic. No long-term follow-up. Temporary 3-month placement of FCSEMSs was effective in resolving pancreatic-duct strictures in chronic pancreatitis, with an acceptable morbidity profile. Modified FCSEMSs can prevent stent migration, but may be associated with de novo duct strictures. Further trials are needed to assess long-term safety and efficacy. Copyright 2010 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

TOKYO criteria 2014 for transpapillary biliary stenting.

PubMed

Isayama, Hiroyuki; Hamada, Tsuyoshi; Yasuda, Ichiro; Itoi, Takao; Ryozawa, Shomei; Nakai, Yousuke; Kogure, Hirofumi; Koike, Kazuhiko

2015-01-01

It is difficult to carry out meta-analyses or to compare the results of different studies of biliary stents because there is no uniform evaluation method. Therefore, a standardized reporting system is required. We propose a new standardized system for reporting on biliary stents, the 'TOKYO criteria 2014', based on a consensus among Japanese pancreatobiliary endoscopists. Instead of stent occlusion, we use recurrent biliary obstruction, which includes occlusion and migration. The time to recurrent biliary obstruction was estimated using Kaplan-Meier analysis with the log-rank test. We can evaluate both plastic and self-expandable metallic stents (uncovered and covered). We also propose specification of the cause of recurrent biliary obstruction, identification of complications other than recurrent biliary obstruction, indication of severity, measures of technical and clinical success, and a standard for clinical care. Most importantly, the TOKYO criteria 2014 allow comparison of biliary stent quality across studies. Because blocked stents can be drained not only using transpapillary techniques but also by an endoscopic ultrasonography-guided transmural procedure, we should devise an evaluation method that includes transmural stenting in the near future. © 2014 The Authors. Digestive Endoscopy © 2014 Japan Gastroenterological Endoscopy Society.

Endoscopic stenting as bridge-to-surgery (BTS) in left-sided obstructing colorectal cancer: Experience with conformable stents.

PubMed

Parodi, Andrea; De Ceglie, Antonella; De Luca, Luca; Conigliaro, Rita; Naspetti, Riccardo; Arpe, Paola; Coccia, Gianni; Conio, Massimo

2016-11-01

Compared to emergency surgery, self-expandable metallic stents are effective and safe when used as bridge-to-surgery (BTS) in operable patients with acute colorectal cancer obstruction. In this study, we report data on the new conformable colonic stents. To evaluate clinical effectiveness of conformable stents as BTS in patients with acute colorectal cancer obstruction. This was a retrospective study. The study was conducted at six Italian Endoscopic Units. Data about patients with acute malignant colorectal obstruction were collected between 2007 and 2012. All patients were treated with conformable stents as BTS. Technical success, clinical success, rate of primary anastomosis and colostomy, early and late complications were evaluated. Data about 88 patients (62 males) were reviewed in this study. Conformable SEMS were correctly deployed in 86 out of 88 patients, with resolution of obstruction in all treated patients. Tumor resection with primary anastomosis was possible in all patients. A temporary colostomy was performed in 40. Early complications did not occur. Late complications occurred in 11 patients. Stent migration was significantly higher in patients treated with partially-covered stents compared to the uncovered group (35% vs. 0%, P<0.001). Endoscopical re-intervention was required in 12% of patients. One patient with rectal cancer had an anastomotic dehiscence after surgery and he was successfully treated with endoscopic clipping. One year after surgery, all patients were alive and local recurrence have not been documented. This was a retrospective and uncontrolled study. Preliminary data from this large case series are encouraging, with a high rate of technical and clinical success and low rate of clinically relevant complications. Partially-covered SEMS should be avoided in order to reduce the risk of endoscopic re-intervention. Copyright © 2016. Published by Elsevier Masson SAS.

One Year Outcomes of 101 BeGraft Stent Grafts used as Bridging Stents in Fenestrated Endovascular Repairs.

PubMed

Spear, Rafaelle; Sobocinski, Jonathan; Hertault, Adrien; Delloye, Matthieu; Azzauiu, Richard; Fabre, Dominique; Haulon, Stéphan

2018-04-01

To evaluate the outcomes of the second generation BeGraft balloon expandable covered stent Graft System (Bentley InnoMed, Hechingen, Germany) implanted as bridging stent grafts during fenestrated endovascular aortic repair (FEVAR) of complex aneurysms. This was a single centre prospective study including all consecutive patients treated by FEVAR performed with second generation BeGraft stent grafts as bridging stents. Demographics of patients, diameter and length of the bridging stent grafts, technical success, re-interventions, occlusions, post-operative events, and imaging (Cone Beam CT and/or CT scan, and contrast enhanced ultrasound) were prospectively collected in an electronic database. Duplex ultrasound was performed before discharge and at 6 month follow-up. At 1 year, patients were evaluated clinically and by imaging (CT and ultrasound). Between November 2015 and September 2016, 39 consecutive patients (one woman) were treated with custom made fenestrated endografts (2-5 fenestrations) for complex aneurysms or type 1 endoleak after EVAR, using a variety of bridging stents including the BeGraft. All 101 BeGraft stent grafts were successfully delivered and deployed. There was no in hospital mortality. Early fenestration patency rate was 99% (96/97); the sole target vessel post-operative occlusion was secondary to a dissection of the renal artery distal to the stent. Complementary stenting was unsuccessful in recovering renal artery patency; bilateral renal stent occlusion was observed in the same patient on a CT scan performed 2 months after the procedure. He required post-operative dialysis. No additional renal impairment was observed. During follow-up (median 13 months [11-15]), all fenestrations stented with BeGraft stent grafts remained patent (95/97, 98%). One type 1b endoleak was detected and treated (2.6%). BeGraft stent grafts used as bridging stents during FEVAR are associated with favourable outcomes at 1 year follow-up. Long-term follow-up is

Tracheal reaction to three different intraluminal stents in an animal model of tracheomalacia.

PubMed

Weinberg, Mark; Sandbank, Judith; Flumenblit, Yoseph; Klin, Baruch; Vinograd, Itzhak

2005-06-01

Three different internal airway stents were studied in an animal model of tracheomalacia: the Palmaz stent (Johnson & Johnson, Warren, New Jersey) and the NIR stent (Medinol Ltd., Tel Aviv, Israel)--both made of stainless steel in the form of tubular mesh--and the Nitinol stent, made of nickel-titanium formed into a spiral shape. All three stents could be adequately stabilized in the malacic tracheal segment. The Nitinol stent (Medinol Ltd., Tel Aviv, Israel) proved to be less reactive to the tracheal mucosa, demonstrated higher biocompatibility with significantly less granulation tissue formation, and showed superior radial resistance. Extraction of the Nitinol stent also proved to be much smoother. This stent may be the stent of choice in the treatment of tracheo- and bronchomalacia.

Endoscopic management with inside stent for proximal benign biliary stricture after laparoscopic cholecystectomy.

PubMed

Sasahira, Naoki; Isayama, Hiroyuki; Kogure, Hirofumi; Tsujino, Takeshi; Koike, Kazuhiko

2012-05-01

Endoscopic placement of a plastic stent is the standard drainage for a symptomatic benign biliary stricture. Although a removable fully covered self-expandable metal stent has been applied for distal benign biliary stricture, placement of a plastic stent remains the standard treatment for proximal benign biliary stricture. Placement of a plastic stent above the papilla (inside stent) is an alternative to the conventional method because of its preventive effect against the dysfunction of the stent in patients with proximal benign biliary stricture. © 2012 The Authors. Digestive Endoscopy © 2012 Japan Gastroenterological Endoscopy Society.

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.

Risk Factors for Migration, Fracture, and Dislocation of Pancreatic Stents

PubMed Central

Kawaguchi, Yoshiaki; Lin, Jung-Chun; Kawashima, Yohei; Maruno, Atsuko; Ito, Hiroyuki; Ogawa, Masami; Mine, Tetsuya

2015-01-01

Aim. To analyze the risk factors for pancreatic stent migration, dislocation, and fracture in chronic pancreatitis patients with pancreatic strictures. Materials and Methods. Endoscopic stent placements (total 386 times) were performed in 99 chronic pancreatitis patients with pancreatic duct stenosis at our institution between April 2006 and June 2014. We retrospectively examined the frequency of stent migration, dislocation, and fracture and analyzed the patient factors and stent factors. We also investigated the retrieval methods for migrated and fractured stents and their success rates. Results. The frequencies of stent migration, dislocation, and fracture were 1.5% (5/396), 0.8% (3/396), and 1.2% (4/396), respectively. No significant differences in the rates of migration, dislocation, or fracture were noted on the patient factors (etiology, cases undergoing endoscopic pancreatic sphincterotomy, location of pancreatic duct stenosis, existence of pancreatic stone, and approach from the main or minor papilla) and stent factors (duration of stent placement, numbers of stent placements, stent shape, diameter, and length). Stent retrieval was successful in all cases of migration. In cases of fractured stents, retrieval was successful in 2 of 4 cases. Conclusion. Stent migration, fracture, and dislocation are relatively rare, but possible complications. A good understanding of retrieval techniques is necessary. PMID:25945085

A non-randomized study in consecutive patients with postcholecystectomy refractory biliary leaks who were managed endoscopically with the use of multiple plastic stents or fully covered self-expandable metal stents (with videos).

PubMed

Canena, Jorge; Liberato, Manuel; Meireles, Liliane; Marques, Inês; Romão, Carlos; Coutinho, António Pereira; Neves, Beatriz Costa; Veiga, Pedro Mota

2015-07-01

Endoscopic management of postcholecystectomy biliary leaks is widely accepted as the treatment of choice. However, refractory biliary leaks after a combination of biliary sphincterotomy and the placement of a large-bore (10F) plastic stent can occur, and the optimal rescue endotherapy for this situation is unclear. To compare the clinical effectiveness of the use of a fully covered self-expandable metal stent (FCSEMS) with the placement of multiple plastic stents (MPS) for the treatment of postcholecystectomy refractory biliary leaks. Prospective study. Two tertiary-care referral academic centers and one general district hospital. Forty consecutive patients with refractory biliary leaks who underwent endoscopic management. Temporary placement of MPS (n = 20) or FCSEMSs (n = 20). Clinical outcomes of endotherapy as well as the technical success, adverse events, need for reinterventions, and prognostic factors for clinical success. Endotherapy was possible in all patients. After endotherapy, closure of the leak was accomplished in 13 patients (65%) who received MPS and in 20 patients (100%) who received FCSEMSs (P = .004). The Kaplan-Meier (log-rank) leak-free survival analysis showed a statistically significant difference between the 2 patient populations (χ(2) [1] = 8.30; P < .01) in favor of the FCSEMS group. Use of <3 plastic stents (P = .024), a plastic stent diameter <20F (P = .006), and a high-grade biliary leak (P = .015) were shown to be significant predictors of treatment failure with MPS. The 7 patients in whom placement of MPS failed were retreated with FCSEMSs, resulting in closure of the leaks in all cases. Non-randomized design. In our series, the results of the temporary placement of FCSEMSs for postcholecystectomy refractory biliary leaks were superior to those from the use of MPS. A randomized study is needed to confirm our results before further recommendations. Copyright © 2015 American Society for Gastrointestinal Endoscopy

The impact of precise robotic lesion length measurement on stent length selection: ramifications for stent savings.

PubMed

Campbell, Paul T; Kruse, Kevin R; Kroll, Christopher R; Patterson, Janet Y; Esposito, Michele J

2015-09-01

Coronary stent deployment outcomes can be negatively impacted by inaccurate lesion measurement and inappropriate stent length selection (SLS). We compared visual estimate of these parameters to those provided by the CorPath 200® Robotic PCI System. Sixty consecutive patients who underwent coronary stent placement utilizing the CorPath System were evaluated. The treating physician assessed orthogonal images and provided visual estimates of lesion length and SLS. The robotic system was then used for the same measures. SLS was considered to be accurate when visual estimate and robotic measures were in agreement. Visual estimate SLSs were considered to be "short" or "long" if they were below or above the robotic-selected stents, respectively. Only 35% (21/60) of visually estimated lesions resulted in accurate SLS, whereas 33% (20/60) and 32% (19/60) of the visually estimated SLSs were long and short, respectively. In 5 cases (8.3%), 1 less stent was placed based on the robotic lesion measurement being shorter than the visual estimate. Visual estimate assessment of lesion length and SLS is highly variable with 65% of the cases being inaccurately measured when compared to objective measures obtained from the robotic system. The 32% of the cases where lesions were visually estimated to be short represents cases that often require the use of extra stents after the full lesion is not covered by 1 stent [longitudinal geographic miss (LGM)]. Further, these data showed that the use of the robotic system prevented the use of extra stents in 8.3% of the cases. Measurement of lesions with robotic PCI may reduce measurement errors, need for extra stents, and LGM. Copyright © 2015 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.

Antireflux Metal Stent as a First-Line Metal Stent for Distal Malignant Biliary Obstruction: A Pilot Study.

PubMed

Hamada, Tsuyoshi; Isayama, Hiroyuki; Nakai, Yousuke; Togawa, Osamu; Takahara, Naminatsu; Uchino, Rie; Mizuno, Suguru; Mohri, Dai; Yagioka, Hiroshi; Kogure, Hirofumi; Matsubara, Saburo; Yamamoto, Natsuyo; Ito, Yukiko; Tada, Minoru; Koike, Kazuhiko

2017-01-15

In distal malignant biliary obstruction, an antireflux metal stent (ARMS) with a funnel-shaped valve is effective as a reintervention for metal stent occlusion caused by reflux. This study sought to evaluate the feasibility of this ARMS as a first-line metal stent. Patients with nonresectable distal malignant biliary obstruction were identified between April and December 2014 at three Japanese tertiary centers. We retrospectively evaluated recurrent biliary obstruction and adverse events after ARMS placement. In total, 20 consecutive patients were included. The most common cause of biliary obstruction was pancreatic cancer (75%). Overall, recurrent biliary obstruction was observed in seven patients (35%), with a median time to recurrent biliary obstruction of 246 days (range, 11 to 246 days). Stent occlusion occurred in five patients (25%), the causes of which were sludge and food impaction in three and two patients, respectively. Stent migration occurred in two patients (10%). The rate of adverse events associated with ARMS was 25%: pancreatitis occurred in three patients, cholecystitis in one and liver abscess in one. No patients experienced nonocclusion cholangitis. The ARMS as a first-line biliary drainage procedure was feasible. Because the ARMS did not fully prevent stent dysfunction due to reflux, further investigation is warranted.

Internal versus external ureteric stents for uretero-ileal anastomosis after laparoscopic radical cystectomy with orthotopic neobladder: A prospective comparative study.

PubMed

Abdel Hakim, Mahmoud A; Abdalla, Ahmed A; Saad, Ismail R; ElSheemy, Mohammed S; El Feel, Ahmed S; Salem, Hosni K; Abdel Hakim, Amr M

2016-06-01

To prospectively compare the use of external ureteric stents with internal JJ stenting of the uretero-ileal anastomosis in patients undergoing laparoscopic radical cystectomy (LRC) with a Y-shaped ileal orthotopic neobladder (ON). The study included 69 patients undergoing LRC with ON. Patients were grouped according to the type of uretero-ileal stents used. An external ureteric stent was used in Group A (33 patients) and a JJ stent was used in Group B (36). We prospectively compared the duration of hospital stay, the incidence of short- and intermediate-term complications in the two study groups. The mean (SD) follow-up periods were 29.18 (3.94) and 28.19 (3.37) months for patients in Groups A and B, respectively. Perioperative patient characteristics were comparable in the two study groups. The use of JJ stenting was associated with a shorter hospital stay compared with external stenting, at a mean (SD) of 14.63 (3.74) and 6.8 (3.03) days in Groups A and B, respectively (P < 0.001). The incidence of urinary leakage was comparable in the two study groups, at 6.1% in Group A vs 8.3% in Group B (P = 1.0). Strictures of the uretero-ileal anastomosis occurred in two patients (6%) in Group A and confirmed by intravenous urography. All strictures were treated with antegrade JJ fixation. JJ stents could be used as an effective alternative to external ureteric stents to support the uretero-ileal anastomosis. JJ stenting is associated with a shorter hospital stay and similar complication rates compared with external stenting in patients undergoing LRC with ON.

Repeated unit cell (RUC) approach for pure bending analysis of coronary stents.

PubMed

Ju, Feng; Xia, Zihui; Zhou, Chuwei

2008-08-01

Flexibility is one of the key properties of coronary stents. The objective of this paper is to characterize the bending behaviour of stents through finite element analysis with repeated unit cell (RUC) models. General periodic boundary conditions for the RUC under the pure bending condition are formulated. It is found that the proposed RUC approach can provide accurate numerical results of bending behaviour of stents with much less computational costs. Bending stiffness, post-yield bending behaviour and the relationship between moment and bending curvature are investigated for Palmaz-Schatz stents and stents with the V- and S-shaped links. It is found that the effect of link geometry on the bending behaviour of stent is significant. The behaviour of stents subjected to cyclic bending is also investigated.

A prospective group sequential study evaluating a new type of fully covered self-expandable metal stent for the treatment of benign biliary strictures (with video).

PubMed

Poley, Jan-Werner; Cahen, Djuna L; Metselaar, Herold J; van Buuren, Henk R; Kazemier, Geert; van Eijck, Casper H J; Haringsma, Jelle; Kuipers, Ernst J; Bruno, Marco J

2012-04-01

Fully-covered self expandable metal stents (fcSEMSs) are an alternative to progressive plastic stenting for the treatment of benign biliary strictures (BBS) with the prospect of a higher treatment efficacy and the need for fewer ERCPs, thereby reducing the burden for patients and possibly costs. Key to this novel treatment is safe stent removal. To investigate the feasibility and safety of stent removal of a fcSEMS with a proximal retrieval lasso: a long wire thread integrated in the proximal ends of the wire mesh that hangs freely in the stent lumen. Pulling it enables gradual removal of the stent inside-out. A secondary aim was success of stricture resolution. Non-randomized, prospective follow-up study with 3 sequential cohorts of 8 patients with BBS. Academic tertiary referral center. Eligible patients had strictures either postsurgical (post-cholecystectomy (LCx) or liver transplantation (OLT)), due to chronic pancreatitis (CP), or papillary stenosis (PF). Strictures had to be located at least 2 cm below the liver hilum. All patients had one plastic stent in situ across the stricture and had not undergone previous treatment with either multiple plastic stents or fcSEMS. The first cohort of patients underwent stent placement for 2 months, followed by 3 months if the stricture had not resolved. The second and third cohort started with 3 months and 4 months, respectively, both followed by another 4 months if indicated. Treatment success was defined by stricture resolution at cholangiography, the ability to pass an inflated extraction balloon and clinical follow-up (at least 6 months). safety of stent removal. Secondary outcomes were complications and successful stricture resolution. A total of 23 patients (11 female; 20-67 yrs) were eligible for final analysis. One patient developed a malignant neuroendocrine tumor in the setting of CP. Strictures were caused by CP (13), OLT (6), LCx (3) and PF (1). In total 39 fcSEMS were placed and removed. Removals were easy

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.

Fast Virtual Stenting with Active Contour Models in Intracranical Aneurysm

PubMed Central

Zhong, Jingru; Long, Yunling; Yan, Huagang; Meng, Qianqian; Zhao, Jing; Zhang, Ying; Yang, Xinjian; Li, Haiyun

2016-01-01

Intracranial stents are becoming increasingly a useful option in the treatment of intracranial aneurysms (IAs). Image simulation of the releasing stent configuration together with computational fluid dynamics (CFD) simulation prior to intervention will help surgeons optimize intervention scheme. This paper proposed a fast virtual stenting of IAs based on active contour model (ACM) which was able to virtually release stents within any patient-specific shaped vessel and aneurysm models built on real medical image data. In this method, an initial stent mesh was generated along the centerline of the parent artery without the need for registration between the stent contour and the vessel. Additionally, the diameter of the initial stent volumetric mesh was set to the maximum inscribed sphere diameter of the parent artery to improve the stenting accuracy and save computational cost. At last, a novel criterion for terminating virtual stent expanding that was based on the collision detection of the axis aligned bounding boxes was applied, making the stent expansion free of edge effect. The experiment results of the virtual stenting and the corresponding CFD simulations exhibited the efficacy and accuracy of the ACM based method, which are valuable to intervention scheme selection and therapy plan confirmation. PMID:26876026

Balloon-Expandable Stent Graft for Treating Uretero-Iliac Artery Fistula

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

Guntau, Moritz, E-mail: guntau@med.uni-marburg.de; Hegele, Axel; Rheinheimer, Stephan

PurposeTo evaluate the safety, efficacy and outcome of percutaneous balloon-expandable covered stent graft placement for uretero-iliac artery fistula (UAF) treatment.MethodsThis retrospective study evaluated the single-center experience of percutaneous balloon-expandable covered stent graft placement (ADVANTA™, Atrium Hudson, NH, USA) in UAF. Data were obtained from a prospective institutional database. Patient follow-up included complications, symptoms recurrence and mortality rate.ResultsTen UAFs in eight patients (3 males; 5 females) with a mean age of 64.5 (35–77) years were identified. All patients had a history pelvic malignancy, extirpative surgery (n = 6), long-term ureteral stenting (n = 7) and pelvic radiation (n = 5). All procedures were completed successfully without complications.more » Thirty-day mortality rate was zero. At a median follow-up of 6 (1–60) months, one patient suffered recurrent hematuria requiring a secondary stent graft placement 26 months after the initial treatment. During follow-up, five patients died of the underlying disease (43, 66, 105, and 183 and 274 days after the last procedure).ConclusionPercutaneous balloon-expandable stent graft placement in UAF is a safe and effective treatment option. Implantation of stent grafts should be considered as treatment of choice in UAF.« less

Newly Designed Y-configured Single-Catheter Stenting for the Treatment of Hilar-Type Nonanastomotic Biliary Strictures After Orthotopic Liver Transplantation

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

Wang Changming; Li Xuan, E-mail: lixuanbysy@163.com; Song Shibing

2012-02-15

Purpose: This study was designed to introduce our novel technique of percutaneous single catheter placement into the hilar bile ducts strictures while fulfilling the purpose of bilateral biliary drainage and stenting. We investigated the efficacy and safety of the technique for the treatment of hilar nonanastomotic biliary strictures. Methods: Ten patients who were post-orthotopic liver transplantation between July 2000 and July 2010 were enrolled in this study. Percutaneous Y-configured single-catheter stenting for bilateral bile ducts combined with balloon dilation was designed as the main treatment approach. Technical success rate, clinical indicators, complications, and recurrent rate were analyzed. Results: Technical successmore » rate was 100%. Nine of the ten patients had biochemical normalization, cholangiographic improvement, and clinical symptoms relief. None of them experienced recurrence in a median follow-up of 26 months after completion of therapy and removal of all catheters. Complications were minor and limited to two patients. The one treatment failure underwent a second liver transplantation but died of multiple system organ failure. Conclusions: Percutaneous transhepatic Y-configured single-catheter stenting into the hilar bile ducts is technically feasible. The preliminary trial of this technique combined with traditional PTCD or choledochoscopy for the treatment of hilar biliary strictures after orthotopic liver transplantation appeared to be effective and safe. Yet, further investigation is needed.« less

Serial Versus Direct Dilation of Small Diameter Stents Results in a More Predictable and Complete Intentional Transcatheter Stent Fracture: A PICES Bench Testing Study.

PubMed

Crystal, Matthew A; Morgan, Gareth J; Danon, Saar; Gray, Robert G; Gruenstein, Daniel H; Gordon, Brent M; Goldstein, Bryan H

2018-01-01

Balloon-expandable stents, implanted in infants and children with congenital heart disease (CHD), often require redilation to match somatic growth. Small diameter stents may eventually require longitudinal surgical transection to prevent iatrogenic vascular stenosis. Intentional transcatheter stent fracture (TSF) is an emerging alternative approach to stent transection, but little is known about the optimal stent substrate and best protocol to improve the likelihood of successful TSF. Bench testing was performed with a stent dilation protocol. After recording baseline characteristics, stents were serially or directly dilated using ultra-high-pressure balloons (UHPB) until fracture occurred or further stent dilation was not possible. Stent characteristics recorded were as follows: cell design, metallurgy, mechanism, and uniformity of fracture. Stents tested included bare-metal coronary stents, premounted small diameter stents, and ePTFE-covered small diameter premounted stents. Ninety-four stents representing 9 distinct models were maximally dilated, with 80 (85%) demonstrating evidence of fracture. Comprehensive fracture details were recorded in 64 stents: linear and complete in 34/64 stents (53.1%), linear and incomplete in 9/64 stents (14.1%), transverse/complex and complete in 6/64 stents (9.4%), and transverse/complex and incomplete in 15/64 stents (23.4%). Stent fracture was not accomplished in some stent models secondary to significant shortening, i.e., "napkin-ring" formation. Serial dilation resulted in evidence of fracture in 62/67 (92.5%) stents compared with 18/27 (66.7%) stents in the direct dilation group (p = 0.003). Intentional TSF is feasible in an ex vivo model. Serial dilation more reliably expanded the stent and allowed for ultimate stent fracture, whereas direct large diameter dilation of stents was more likely to generate a "napkin-ring" configuration, which may be more resistant to fracture. In vivo animal and human testing is necessary to

Long-Term Outcomes of Double-Layered Polytetrafluoroethylene Membrane-Covered Self-Expandable Segmental Metallic Stents (Uventa) in Patients with Chronic Ureteral Obstructions: Is It Really Safe?

PubMed

Kim, Myong; Hong, Bumsik; Park, Hyung Keun

2016-12-01

To evaluate the long-term clinical efficacy and safety of double-layered polytetrafluoroethylene membrane-covered self-expandable segmental metallic stents (Uventa) in patients with chronic ureteral obstruction. In a retrospective study, a total of 50 ureter units (44 patients) with chronic obstructions were included from July 2010 to May 2015. Indications for Uventa placement were primary stenting for malignant ureteral obstruction, failed conventional polymeric Double-J stent (PS), or percutaneous nephrostomy (PCN) technique, with comorbidities or fears limiting PS/PCN changes, or with irritation or pain due to PS/PCN. Patients underwent Uventa stent placement using the antegrade or retrograde approach. There were no immediate procedure-related complications, and all stents were placed in the proper sites. During the median follow-up of 30.9 (interquartile range [IQR], 8.1-49.0) months, the primary (no obstruction and no additional intervention) and overall success (no obstruction and no additional intervention except supplementary Uventa) was 30.0% and 34.0%, respectively. Moreover, 14 of 50 ureter units (28.0%) experienced major complications (≥Clavien-Dindo class IIIb), such as ureteroarterial fistula (three cases, 6.0%), ureteroenteric fistula (three, 6.0%), ureterovaginal fistula (one, 2.0%), ureter perforation (one, 2.0%), uncontrollable bleeding (one, 2.0%), and complete obstruction (five, 10.0%). On univariate analysis, major complications were associated with female (odds ratio [OR] = 6.000), cervical cancer (OR = 4.667), ureteral stricture length (≥6.0 cm, OR = 4.583), and placement duration (≥24.0 months, OR = 20.429; all p < 0.05). In long-term follow-up, the Uventa stent demonstrated poor treatment outcomes with frequent major complications in patients with chronic ureteral obstructions.

Robot-assisted antegrade in-situ fenestrated stent grafting.

PubMed

Riga, Celia V; Bicknell, Colin D; Wallace, Daniel; Hamady, Mohamad; Cheshire, Nicholas

2009-05-01

To determine the technical feasibility of a novel approach of in-situ fenestration of aortic stent grafts by using a remotely controlled robotic steerable catheter system in the porcine model. A 65-kg pig underwent robot-assisted bilateral antegrade in-situ renal fenestration of an abdominal aortic stent graft with subsequent successful deployment of a bare metal stent into the right renal artery. A 16-mm iliac extension covered stent served as the porcine aortic endograft. Under fluoroscopic guidance, the graft was punctured with a 20-G customized diathermy needle that was introduced and kept in place by the robotic arm. The needle was exchanged for a 4 x 20 mm cutting balloon before successful deployment of the renal stent. Robot-assisted antegrade in-situ fenestration is technically feasible in a large mammalian model. The robotic system enables precise manipulation, stable positioning, and minimum instrumentation of the aorta and its branches while minimizing radiation exposure.

Robot-Assisted Antegrade In-Situ Fenestrated Stent Grafting

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

Riga, Celia V., E-mail: c.riga@imperial.ac.uk; Bicknell, Colin D.; Wallace, Daniel

2009-05-15

To determine the technical feasibility of a novel approach of in-situ fenestration of aortic stent grafts by using a remotely controlled robotic steerable catheter system in the porcine model. A 65-kg pig underwent robot-assisted bilateral antegrade in-situ renal fenestration of an abdominal aortic stent graft with subsequent successful deployment of a bare metal stent into the right renal artery. A 16-mm iliac extension covered stent served as the porcine aortic endograft. Under fluoroscopic guidance, the graft was punctured with a 20-G customized diathermy needle that was introduced and kept in place by the robotic arm. The needle was exchanged formore » a 4 x 20 mm cutting balloon before successful deployment of the renal stent. Robot-assisted antegrade in-situ fenestration is technically feasible in a large mammalian model. The robotic system enables precise manipulation, stable positioning, and minimum instrumentation of the aorta and its branches while minimizing radiation exposure.« 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.

Predictors of early stent occlusion among plastic biliary stents.

PubMed

Khashab, Mouen A; Kim, Katherine; Hutfless, Susan; Lennon, Anne Marie; Kalloo, Anthony N; Singh, Vikesh K

2012-09-01

A major disadvantage of plastic biliary stents is their short patency rates. The aim of this study was to identify predictors of early stent occlusion among patients receiving conventional plastic biliary stents. Early stent occlusion was defined as worsening cholestatic liver test results of a severity sufficiently significant to warrant ERCP with stent exchange prior to the planned stent exchange, or as symptoms of cholangitis. The association of cumulative stent diameter, demographics, stricture location, procedure indication, Charlson comorbidity index, history of prior early stent occlusion, presence of gallbladder, and performance of sphincteromy with the occurrence of early stent occlusion was studied using logistic regression and multivariate analysis. Our patient cohort comprised 343 patients (mean age 59.3 years) who underwent 561 ERCP procedures with the placement of one or more plastic biliary stents (mean number of stents per procedure 1.2, mean total diameter of stents per procedure 12 Fr). Early stent occlusion occurred in 73 (13 %) procedures. Female gender was protective against early stent occlusion (adjusted OR 0.54, 95 % CI 0.32-0.90, p = 0.02), while hilar stricture location was independently associated with a significantly increased risk of early stent occlusion (adjusted OR 3.41, 95 % CI 1.68-6.90, p = 0.0007). Early occlusion of conventional biliary stents occurred in 13 % of cases. While female gender decreased the risk of early stent occlusion, hilar stricture location was a significant predictor of early stent occlusion. Our results suggest that physicians should consider early elective stent exchange in patients with hilar strictures.

Sensor to detect endothelialization on an active coronary stent

PubMed Central

2010-01-01

Background A serious complication with drug-eluting coronary stents is late thrombosis, caused by exposed stent struts not covered by endothelial cells in the healing process. Real-time detection of this healing process could guide physicians for more individualized anti-platelet therapy. Here we present work towards developing a sensor to detect this healing process. Sensors on several stent struts could give information about the heterogeneity of healing across the stent. Methods A piezoelectric microcantilever was insulated with parylene and demonstrated as an endothelialization detector for incorporation within an active coronary stent. After initial characterization, endothelial cells were plated onto the cantilever surface. After they attached to the surface, they caused an increase in mass, and thus a decrease in the resonant frequencies of the cantilever. This shift was then detected electrically with an LCR meter. The self-sensing, self-actuating cantilever does not require an external, optical detection system, thus allowing for implanted applications. Results A cell density of 1300 cells/mm2 on the cantilever surface is detected. Conclusions We have developed a self-actuating, self-sensing device for detecting the presence of endothelial cells on a surface. The device is biocompatible and functions reliably in ionic liquids, making it appropriate for implantable applications. This sensor can be placed along the struts of a coronary stent to detect when the struts have been covered with a layer of endothelial cells and are no longer available surfaces for clot formation. Anti-platelet therapy can be adjusted in real-time with respect to a patient's level of healing and hemorrhaging risks. PMID:21050471

Biodegradable stents for the treatment of refractory or recurrent benign esophageal stenosis.

PubMed

Imaz-Iglesia, Iñaki; García-Pérez, Sonia; Nachtnebel, Anna; Martín-Águeda, Belén; Sánchez-Piedra, Carlos; Karadayi, Bilgehan; Demirbaş, Ali Rıza

2016-06-01

Esophageal stents are used for the treatment of refractory and recurrent dyphagias. In 2007, esophageal biodegradable stents (EBS) were authorised as an alternative to existing metal and plastic stents in Europe. The advantages claimed for EBS are fewer complications concerning tissue ingrowth, stent migration and stent removal. We performed a systematic review to evaluate the efficacy and safety of EBS compared to fully-covered self-expanding metal stents, self-expanding plastic stents, and esophageal dilation for the treatment of refractory or recurrent benign esophageal stenosis. Three comparative studies (one randomized controlled trial and two cohort studies) were assessed. The studies used different inclusion criteria, had a very small (sample) size and the quality of the evidence was very low. Expert commentary: The current evidence is insufficient to determine the relative efficacy or safety of esophageal biodegradable stents. The results of this systematic review should be updated once new evidence is available.

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.

Investigation on the potential of thulium-fibre-laser irradiation for in-stent tissue ablation (Conference Presentation)

NASA Astrophysics Data System (ADS)

Sroka, Ronald; Frank, Johannes; Reichenberger, Frank; Behr, J.; Gesierich, Wolfgang

2017-04-01

Granulation and tumor regrowth in the area of bronchi stent implants may result in restenosis. It had been shown that by means of Thulium-Fibre-Laser (TFL) a controlled ablation and reduction of the tissue within the stent could be performed. When using Nd:YAG irradiation there is risk for explosive flames, burns of fibre and stent, ruptures of stent meshes as well as perforation of stent and cover. Therefore it was the aim to investigate the safety margin when using TFL. Four different types of clinical used stents (with/without cover) were fixed to pig trachea tissue. Irradiation was performed by fibre assisted TFL-1940nm-laser irradiation while laser power, light application duration and distance, as well as oxygen percentage and contamination were varied. In case of Nitinol-stents rupture were observed at power levels >=7W or distances of <5mm, oxygen conc. of 40% result in increased flame appearance. Polyurethan-covers were ruptured at each variable, flame appeared at 5W. Silicon-stents were destroyed at power levels of about 5W and distances of <5mm and additionally 30%-oxygen or contamination either by blood or soot result in increased appearance of burns and flames. Based upon these observations in clinical TFL-irradiation the distance should >=5 mm and the power level should be <=6W. Furthermore the oxygen conc. should not exceed 30% and short term continuous irradiation of less than 15s exposition should be considered. In case of Silicon-stents light application on contaminated area should be avoided.

Delayed complications after flow-diverter stenting: reactive in-stent stenosis and creeping stents.

PubMed

Cohen, José E; Gomori, John Moshe; Moscovici, Samuel; Leker, Ronen R; Itshayek, Eyal

2014-07-01

We assessed the frequency and severity of changes in stent configuration and location after the treatment of intracranial aneurysms, and patterns of in-stent stenosis. We retrospectively reviewed data for consecutive aneurysm patients managed with endovascular implantation of flow-diverter stents (Silk Flow Diverter [Balt Extrusion, Montmorency, France] and Pipeline Embolization Device [ev3/Coviden, Minneapolis, MN, USA]) from October 2011 to July 2012. Routine 2, 6, 9-12, and 16-20 month follow-up angiograms were compared, with a focus on changes in stent configuration and location from immediately after deployment to angiographic follow-up, and the incidence and development of in-stent stenosis. Thirty-four patients with 42 aneurysms met inclusion criteria. The Silk device was implanted in 16 patients (47%, single device in 15), the Pipeline device in 18 (53%, single device in 16). On first follow-up angiography, in-stent stenosis was observed in 38% of Silk devices and 39% of Pipeline devices. In-stent stenosis was asymptomatic in 12 of 13 patients. One woman presented with transient ischemic attacks and required stent angioplasty due to end tapering and mild, diffuse in-stent stenosis. Configuration and location changes, including stent creeping and end tapering were seen in 2/16 patients (13%) with Silk devices, and 0/18 patients with Pipeline devices. We describe stent creeping and end tapering as unusual findings with the potential for delayed clinical complications. In-stent stenosis, with a unique behavior, is a frequent angiographic finding observed after flow-diverter stent implant. The stenosis is usually asymptomatic; however, close clinical and angiographic monitoring is mandatory for individualized management. Copyright © 2013 Elsevier Ltd. All rights reserved.

Stenting in Malignant Biliary Obstruction.

PubMed

Almadi, Majid A; Barkun, Jeffrey S; Barkun, Alan N

2015-10-01

Decompression of the biliary system in patients with malignant biliary obstruction has been widely accepted and implemented as part of the care. Despite a wealth of literature, there remains a significant amount of uncertainty as to which approach would be most appropriate in different clinical settings. This review covers stenting of the biliary system in cases of resectable or palliative malignant biliary obstruction, potential candidates for biliary drainage, technical aspects of the procedure, as well as management of biliary stent dysfunction. Furthermore, periprocedural considerations including proper mapping of the location of obstruction and the use of antibiotics are addressed. Copyright © 2015 Elsevier Inc. All rights reserved.

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.

Relation between calcium burden, echocardiographic stent frame eccentricity and paravalvular leakage after corevalve transcatheter aortic valve implantation.

PubMed

Di Martino, Luigi F M; Soliman, Osama I I; van Gils, Lennart; Vletter, Wim B; Van Mieghem, Nicolas M; Ren, Ben; Galema, Tjebbe W; Schultz, Carl; de Jaegere, Peter P T; Di Biase, Matteo; Geleijnse, Marcel L

2017-06-01

Paravalvular aortic leakage (PVL) after transcatheter aortic valve implantation (TAVI) is a complication with potentially severe consequences. The relation between native aortic root calcium burden, stent frame eccentricity and PVL was not studied before. Two-hundred-and-twenty-three consecutive patients with severe aortic stenosis who underwent TAVI with a Medtronic CoreValve System© and who had available pre-discharge transthoracic echocardiography were studied. Echocardiographic stent inflow frame eccentricity was defined as major-minor diameter in a short-axis view >2 mm. PVL was scored according to the updated Valve Academic Research Consortium (VARC-2) recommendations. In a subgroup of 162 (73%) patients, the calcium Agatston score was available. Stent frame eccentricity was seen in 77 (35%) of patients. The correlation between the Agatston score and stent frame eccentricity was significant (ρ = 0.241, P = 0.003). Paravalvular leakage was absent in 91 cases (41%), mild in 67 (30%), moderate in 51 (23%), and severe in 14 (6%) cases. The correlation between stent frame eccentricity and PVL severity was significant (ρ = 0.525, P < 0.0001). There was a relation between particular eccentric stent frame shapes and the site of PVL. Calcification of the aortic annulus is associated with a subsequent eccentric shape of the CoreValve prosthesis. This eccentric shape results in more PVL, with the localization of PVL related to the shape of stent frame eccentricity. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2017. For permissions, please email: journals.permissions@oup.com.

The development of self-expanding peripheral stent with ion-modified surface layer

NASA Astrophysics Data System (ADS)

Lotkov, Alexander I.; Kashin, Oleg A.; Kudryashov, Andrey N.; Krukovskii, Konstantin V.; Kuznetsov, Vladimir M.; Borisov, Dmitry P.; Kretov, Evgenii I.

2016-11-01

In work researches of chemical composition of surface layers of self-expanding stents of nickel-titanium (NiTi) and their functional and mechanical properties after plasma immersion processing by ions of silicon (Si). It is established that in the treatment in the inner and outer surfaces of stents formed doped silicon layer with a thickness of 80 nm. The formation of the doped layer does not impair the functional properties of the stent. At human body temperature, the stent is fully restore its shape after removing the deforming load. The resulting graph of loading of stents during their compression between parallel plates. The research results allow the conclusion that Si-doped stents are promising for treatment of peripheral vascular disease. However, related studies on laboratory animals are required.

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

Endoscopic control of enterocutaneous fistula by dual intussuscepting stent technique.

PubMed

Melich, George; Pai, Ajit; Balachandran, Banujan; Marecik, Slawomir J; Prasad, Leela M; Park, John J

2016-09-01

Large high-output enterocutaneous fistulas pose great difficulties, especially in the setting of recent surgery and compromised skin integrity. This video demonstrates a new technique of endoscopic control of enterocutaneous fistula by using two covered overlapping stents. In brief, the two stents are each inserted endoscopically, one proximal, and the other distal to the fistula with 2 cm of each stent protruding cutaneously. Following this, the proximal stent is crimped and intussuscepted into the distal stent with an adequate overlap. A prolene suture is passed through the anterior wall of both stents to prevent migration. The two stents used were evolution esophageal stents-10 cm long, fully covered, double-flared with non-flared and flared diameters being 20 and 25 mm, respectively (product number EVO-FC-20-25-10-E, Cook Medical, Bloomington, IN, USA). The patient featured in this video developed a high-output enterocutaneous fistula proximal to a loop ileostomy, which was created following a small bowel leak after a curative surgery for bladder cancer. Using the technique featured in this video (schematic depicted in Fig. 1), the patient was nutritionally optimized with oral feeds from albumin of 0.9-3.4 g/dl within 2 months despite prior failure to achieve nutrition optimization and adequate skin protection with combination of oral and/or parenteral nutrition. Three months after stenting, following nutritional optimization and improvement of skin coverage, definitive procedure consisted of uncomplicated fistula resection with primary stapled side-to-side functional end-to-end anastomosis. The stents were not completely incorporated into the mucosa and were rather easily pulled through the residual fistula opening just prior to the surgery. Only minimal fibrosis was noted and less than 20 cm of involved small bowel needed to be resected. Had the fistula have closed completely, the options would have included (1) proceeding to bowel resection with

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.

Covered self-expanding metal stents may be preferable to plastic stents in the treatment of chronic pancreatitis-related biliary strictures: a systematic review comparing 2 methods of stent therapy in benign biliary strictures.

PubMed

Siiki, Antti; Helminen, Mika; Sand, Juhani; Laukkarinen, Johanna

2014-08-01

Covered self-expanding metal stents (CSEMS) are being increasingly used in the endoscopic treatment of benign biliary strictures (BBS). There is no solid evidence yet to support their routine use. To evaluate feasibility, success rate, and complications of CSEMS compared with multiple plastic stents (PS) in BBS in a systematic review. A systematic search of electronic databases (Medline, Scopus, and Embase) for studies published from 2000 to 2012 combined to hand-search of reference lists resulted 4977 articles. Out of 99 potentially relevant studies selected for full-text review, 12 CSEMS (376 patients) and 13 PS studies (570 patients) met the final inclusion criteria. A systematic review comparing the 2 methods was made using proportion meta-analysis. A tendency to successful use of CSEMS in strictures related to chronic pancreatitis (CP) was shown: clinical success of 77% and 33% [95% confidence interval (CI), 61%-94% vs. 4%-63%, P=0.06] was achieved with CSEMS and PS at 12 months follow-up, respectively. There were no differences in the success rates of other etiologies except CP or in the early complications. In CSEMS, incidence of late adverse events was lower in CP-related strictures (3% vs. 67%, 95% CI, 0%-13% vs. 17%-99%, P=0.02). The median number of endoscopic retrograde cholangiopancreatographies was lower with CSEMSs: 1.5 versus 3.9 (P=0.002). Improved clinical success with fewer endoscopic sessions and corresponding complication rate may be achieved with CSEMS treatment compared with PS in BBS secondary to CP. In other BBS etiologies, this systematic review remains inconclusive.

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.

Allium Stents: A Novel Solution for the Management of Upper and Lower Urinary Tract Strictures

PubMed Central

Bahouth, Zaher; Moskovitz, Boaz; Halachmi, Sarel; Nativ, Ofer

2017-01-01

Stents are widely use in endoscopic urological procedures. One of the most important indications is the treatment of urinary tract strictures. Allium™ Medical has introduced several types of stents for the treatment of different types of urinary tract strictures, based on anatomic location. All the stents are made of nitinol and coated with a co-polymer that reduces encrustations. These stents are self-expandable and have a large caliber and a high radial force. They have different shapes, designed especially for the treatment of each type of stricture. One of the most important features of Allium-manufactured stents is the ease of removal, due to their special unraveling feature. The company has introduced the Bulbar Urethral Stent (BUS) for treatment of bulbar urethral strictures; a rounded stent available in different lengths. Initial data on 64 patients with bulbar urethral stricture treated with the BUS showed a significant improvement in symptoms, with minimal complications and few adverse events. For treatment of prostate obstruction in patients unfit for surgery or unwilling to undergo a classical prostatic surgery, the Triangular Prostatic Stent (TPS) was introduced, which has a triangular shape that fits in the prostatic urethra. Its body has a high radial force attached to an anchor (which prevents migration) through a trans-sphincteric wire (which reduces incontinence rate). Initial data on 51 patients showed significant improvement in symptoms and in urinary peak flow rate, with a relatively small number of complications. The Round Posterior Stent (RPS) was designed for treatment of post radical prostatectomy bladder neck contracture. This short, round stent has an anchor, which is placed in the bladder neck. This stent being relatively new, the clinical data are still limited. Ureteral strictures can be treated with the Ureteral Stent (URS), which is round-shaped, available in different lengths, and has an anchor option (for very distal or very

Unconstrained Recovery Characterization of Shape-Memory Polymer Networks for Cardiovascular Applications

PubMed Central

Yakacki, Christopher M.; Shandas, Robin; Lanning, Craig; Rech, Bryan; Eckstein, Alex; Gall, Ken

2009-01-01

Shape-memory materials have been proposed in biomedical device design due to their ability to facilitate minimally invasive surgery and recover to a predetermined shape in-vivo. Use of the shape-memory effect in polymers is proposed for cardiovascular stent interventions to reduce the catheter size for delivery and offer highly controlled and tailored deployment at body temperature. Shape-memory polymer networks were synthesized via photopolymerization of tert-butyl acrylate and poly (ethylene glycol) dimethacrylate to provide precise control over the thermomechanical response of the system. The free recovery response of the polymer stents at body temperature was studied as a function of glass transition temperature (Tg), crosslink density, geometrical perforation, and deformation temperature, all of which can be independently controlled. Room temperature storage of the stents was shown to be highly dependent on Tg and crosslink density. The pressurized response of the stents is also demonstrated to depend on crosslink density. This polymer system exhibits a wide range of shape-memory and thermomechanical responses to adapt and meet specific needs of minimally invasive cardiovascular devices. PMID:17296222

Proximal migration of transanastomotic pancreatic stent following pancreaticoduodenectomy and pancreaticojejunostomy.

PubMed

Ammori, B J; White, C M

1999-06-01

The use of catheters to stent the pancreaticojejunal anastomosis following pancreaticoduodenectomy is practiced by some surgeons. Their long-term effects in this setting, however, remain unknown. A 60-yr-old woman underwent a potentially curative pylorus preserving pancreaticoduodenectomy for Stage I ampullary carcinoma. Roux-en-Y pancreaticojejunostomy was constructed over a short stent. She presented 4 yr later with abdominal pain, steatorrhea, and weight loss. Computed tomography revealed a stent within the proximal pancreatic duct, with gross upstream ductal dilatation and parenchymal features of chronic pancreatitis. Laparotomy revealed no disease recurrence. The stent, removed through a jejunotomy, was occluded. On-table pancreatogram demonstrated a 3-cm proximal duct stricture. Drainage was achieved with a lateral pancreaticojejunostomy (modified Puestow procedure). Recovery was uneventful, with clinical recovery of pancreatic exocrine function at 6 mo follow-up. Proximal migration of transanastomotic pancreatic stent with subsequent development of chronic pancreatitis is a potential complication following pancreaticoduodenectomy. It can be managed effectively with stent removal and a lateral pancreaticojejunostomy.

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

Stent patency in patients with distal malignant biliary obstruction receiving chemo(radio)therapy

PubMed Central

Haal, Sylke; van Hooft, Jeanin E.; Rauws, Erik A. J.; Fockens, Paul; Voermans, Rogier P.

2017-01-01

Background and study aims  Recent literature suggests that chemo(radio)therapy might reduce the patency of plastic stents in patients with malignant biliary obstruction. Whether this might also be valid for other types of stents is unknown. The aim of this study was to determine the influence of chemo(radio)therapy on the patency of fully-covered self-expandable metal stents (FCSEMSs) and plastic stents. Patients and methods  We retrospectively reviewed the electronic medical records of patients with distal malignant biliary obstruction who underwent biliary stent placement between April 2001 and July 2015. Primary outcome was duration of stent patency. Secondary outcome was stent patency at 3 and 6 months. We used Kaplan–Meier survival analyses to compare stent patency rates between patients who received chemo(radio)therapy and patients who did not. Results  A total of 291 biliary stents (151 metal and 140 plastic) were identified. The median cumulative stent patency of FCSEMSs did not differ between patients receiving chemo(radio)therapy (n = 51) and those (n = 100) who did not ( P  = 0.70, log-rank test). The estimated cumulative stent patency of plastic stents was also comparable in 99 patients without and 41 patients with chemo(radio)therapy ( P  = 0.73, log-rank test). At 3 and 6 months, FCSEMS patency rates were 87 % and 83 % in patients without chemo(radio)therapy and 96 % and 83 % in patients with therapy, respectively. Plastic patency rates were 69 % and 55 % in patients without and 85 % and 39 % in patients with therapy, respectively. After 1 year, 78 % of the FCSEMSs were still patent in patients without chemo(radio)therapy and 69 % of the FCSEMSs were still patent in patients with therapy. Conclusion  Our data indicate that chemo(radio)therapy does not reduce the patency of biliary fully-covered metal and plastic stents. PMID:29090242