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Sample records for expandable nitinol stent

  1. Self-expanding nitinol stents: material and design considerations.

    PubMed

    Stoeckel, Dieter; Pelton, Alan; Duerig, Tom

    2004-02-01

    Nitinol (nickel-titanium) alloys exhibit a combination of properties which make these alloys particularly suited for self-expanding stents. Some of these properties cannot be found in engineering materials used for stents presently. This article explains the fundamental mechanism of shape memory and superelasticity, and how they relate to the characteristic performance of self-expanding stents. Nitinol stents are manufactured to a size slightly larger than the target vessel size and delivered constrained in a delivery system. After deployment, they position themselves against the vessel wall with a low, "chronic" outward force. They resist outside forces with a significantly higher radial resistive force. Despite the high nickel content of Nitinol, its corrosion resistance and biocompatibility is equal to that of other implant materials. The most common Nitinol stents are listed and described.

  2. Nitinol Self-Expanding Stents for the Superficial Femoral Artery.

    PubMed

    Nathan, Ashwin; Kobayashi, Taisei; Giri, Jay

    2017-04-01

    The superficial femoral artery is a complex artery subject to a unique set of biomechanical loading conditions in its course through the leg. Plain balloon angioplasty and balloon-expandable stents had unacceptably high rates of restenosis, necessitating target vessel revascularization. Nitinol alloy is well suited to provide the strength and flexibility needed of stents to withstand the external forces posed by the environment of the superficial femoral artery. Advances in stent technology with the addition of a slow-releasing antiproliferative agent and changes in scaffold design have shown promise in reducing the rates of stent fracture and in-stent restenosis. Published by Elsevier Inc.

  3. Self-Expandable Nitinol Stent Placement in Homocysteinemic Porcine Aorta

    PubMed Central

    França, Luís Henrique Gil; Pereira, Adamastor Humberto; Perini, Sílvio César

    2008-01-01

    PURPOSE To compare aortic intimal thickening of normal and hyperhomocysteinemic pigs (induced with a methionine-rich diet) following placement of a self-expanding nitinol stent. METHODS Eighteen Macau pigs were used. They were older than eight weeks in age and had an average weight of 30 kg. Pigs were randomly divided into two groups. The first, Group C (control), was fed a regular diet, and the second group, Group M, was fed a methionine-rich diet for 30 days to induce hyperhomocysteinemia. The self-expandable nitinol stents were 25mm in length and 8 mm in diameter after expansion. Blood samples were collected to measure total cholesterol, triglycerides, HDL and homocysteine concentrations. All animals were subjected to angiography. Thirty days after the procedure, the animals were sacrificed, and the abdominal aorta was removed for histological and digital morphometry analysis. RESULTS Under microscopic evaluation, the intima was significantly thicker in Group C than in Group M. When groups were compared by digital morphometric analysis, intimal thickening of the vessel wall was higher in Group C than in Group M. There was no significant change in total cholesterol, triglycerides or HDL concentrations in either group. In group C the levels of plasma homocysteine ranged from 14,40 to 16,73μmol/l; in Group M, plasma homocysteine levels ranged from 17.47 to 59.80 μmol/l after 30 days of a methionine-rich diet. CONCLUSION Compared to normal pigs, less intimal hyperplasia was observed in the abdominal aortas of hyperhomocysteinemic pigs thirty days after the insertion of a self-expandable nitinol stent. PMID:18438578

  4. Use of nitinol self-expandable stents in 26 dogs with tracheal collapse.

    PubMed

    Beranek, J; Jaresova, H; Rytz, U

    2014-02-01

    A study was designed to describe a novel approach to the treatment of tracheal collapse (TC) in dogs using self-expandable nitinol stents. Medical records were reviewed retrospectively for 26 client owned dogs in which nitinol stents were deployed. The entire length of trachea was supported independently of the extent of TC. Two overlapping stents were used instead of one in cases where one stent was not spanning the entire trachea adequately. The diameter of the cranial radiolucent portion of trachea, just behind the cricoid cartilage, was measured as a specific landmark to select the appropriate size of the stent. Two self-expandable nitinol stents were inserted in 9 of 26 dogs; the trachea in the rest of the cases was supported with only one stent. A follow up tracheoscopy was performed in 10 of 26 cases with recurrent clinical signs. Secondary tracheal stenosis in these cases was caused by stent fracture, granuloma or excessive stent shortening. Additional stents were placed successfully to expand the stenotic lumen. A support of the entire trachea may decrease risk of nitinol fracture at the end of the implant. Long term clinical improvement (25 of 26 dogs, 96 %) is comparable with the results of other studies.

  5. Percutaneous treatment of symptomatic superior mesenteric vein stenosis using self-expanding nitinol stents.

    PubMed

    Beyer, L P; Wohlgemuth, W A; Uller, W; Pregler, B; Goessmann, H; Niessen, C; Haimerl, M; Stroszczynski, C; Müller-Wille, R

    2015-10-01

    To evaluate the technical and clinical success of percutaneous superior mesenteric vein (SMV) stenting in symptomatic patients using self-expanding nitinol stents. We retrospectively analyzed the technical and clinical success of percutaneous SMV stenting of 6 symptomatic patients (3 men, mean age 67 years, range 48-81 years). Stenosis of the SMV was caused by postoperative stricture (n=3), pancreas carcinoma (n=1) and pancreatitis (n=2). As a result of the stenosis, 3 patients had symptomatic ascites, 2 patients showed signs of mesenteric ischemia and 1 patient had recurrent gastrointestinal bleeding. Stenting was performed by a percutaneous transhepatic approach using self-expanding nitinol stents. Stenting of the SMV was technically and clinically successful in all patients. No peri-interventional complications occurred. The stent diameters ranged from 6 to 14 mm. During the mean follow-up of 6 months (range, 2-10 months) 1 patient presented early stent occlusion 2 weeks after placement. Stenting of a symptomatic SMV stenosis using self-expanding nitinol stents is feasible and clinically effective. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  6. In situ cooling with ice water for the easier removal of self-expanding nitinol stents

    PubMed Central

    Merkel, Daniel; Brinkmann, Eckhard; Wiens, Daniel; Derwahl, Karl-Michael

    2015-01-01

    Background: It is yet to be determined what effects temperature has on the properties of nitinol in order to simplify the process of removing nitinol self-expanding metal stents (SEMS). Materials and methods: We describe the procedure for removal of SEMS in a total of 11 cases with 9 patients. A study involving cooling of nitinol stents in situ with ice water just before their removal was attempted. Results: All stents were removed successfully. In partially covered and in fully covered stents, the stent rigidity was noticeably reduced following cooling. Stent removal was performed by inversion, which was achieved by pulling on the stent from its distal end. No adverse events were observed during this trial. Conclusion: The higher pliability of the stents after ice-water cooling facilitates stent removal. With this method, a mobilization of all stents by the invagination technique was achieved. The separation of the uncoated stent ends from the intestinal wall by the invagination technique, as well as the mucosal vasoconstriction resulting from the cooling, lead to an easier SEMS removal and may serve to prevent severe bleeding of the mucosal wall during this process. PMID:26134772

  7. Polyurethane-Covered Self-expandable Nitinol Stent for Malignant Biliary Obstruction: Preliminary Results

    SciTech Connect

    Han, Young-Min; Hwang, Seung-Bae; Lee, Soo-Teik; Lee, Jeong-Min; Chung, Gyung-Ho

    2002-10-15

    Purpose: To evaluate the immediate and long-term results in ten patients with malignant biliary obstruction using a polyurethane-covered, self-expandable nitinol stent.Methods: A nitinol stent, fully covered with high-elasticity polyurethane, with an unconstrained diameter of 10 mm and a total length of 60-80 mm, was placed transhepatically under fluoroscopic guidance in ten patients. The length of the biliary obstruction varied between 30-50 mm. The follow-up examination included a clinical assessment, serum bilirubin measurement, and ultrasound examinations at one-month intervals in all patients. Results: Initial stent deployment was successful in eight patients. Two patients experienced proximal migration,which was solved by insertion of two, uncovered Wallstents. One patient had the stent removed after two weeks because of severe nausea and vomiting. One patient had delayed migration of the covered stent after 40 weeks. The follow-up duration was 3-40 weeks (Mean: 16.9 weeks). Seven patients died(3-26 weeks) and three patients survived (24-40 weeks). The bilirubin measurements in all patients had significantly decreased one week after stent insertion. The levels of amylase and lipase had did not increase after stent insertion. Conclusions: Apolyurethane-covered, self-expandable nitinol stent can be used effectively and safely in the treatment of malignant biliary obstruction. The preliminary results are favorable, but there is a need for further large studies to determine both long-term survival and patency.

  8. 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

  9. 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.

  10. A Word of Caution for Extra Large Self-expandable Nitinol Stents.

    PubMed

    Reyes Valdivia, Andrés; Duque Santos, Africa; Alvarez Marcos, Francisco; Romero Lozano, Asunción; Ocaña Guaita, Julia; Gandarias Zúñiga, Claudio

    2017-07-01

    To report an unsuccessful use of large nitinol stent to prevent proximal endoleak in endograft treatment for juxtarenal aortic aneurysm. An 82-year-old male presented coronary disease and severe chronic obstructive pulmonary disease requiring oxygen support. A large 80-mm juxtarenal aneurysm was found on routine urological examination. Neck features were as follows: 7 mm and high anterior-posterior angulation. ASA risk score IV was given. Patient wanted to be treated. We decided a 1-shot intervention based on self-expandable suprarenal fixation endograft with adjunctive extra large self-expandable (high radial force) nitinol stent. Control computed tomography scan demonstrates nitinol stent severe infolding and a possible perforation of the primary endograft. At 6-month follow-up, sac reveals enlargement of 5 mm and 6% volume increase. Patient does not want further treatments due to high risk of procedures. Extreme caution should be taken when using self-expandable extra large nitinol stents for preventive matters. Oversizing should be carefully considered, not necessarily reaching the endograft chosen size. When short and angulated neck morphology co-exists, other devices or procedures may be a better option. Copyright © 2017 Elsevier Inc. All rights reserved.

  11. Treatment of Benign Tracheal Stenosis Utilizing Self-Expanding Nitinol Stents

    SciTech Connect

    Sesterhenn, Andreas M. Wagner, Hans-Joachim; Alfke, Heiko; Werner, Jochen A.; Lippert, Burkard M.

    2004-08-15

    We assessed the results of self-expanding metallic stent insertion into benign proximal tracheal stenosis in patients not appropriate or unfit for surgical repair. Proximal benign tracheal stenoses had occurred in 11 patients (7 men, 4 women, mean age 68.8 years) after long-time intubation (n = 6), tracheostomy (n = 4), or chondropathia (n = 1). Fourteen self-expanding nitinol stents were placed in the patients under general anesthesia with endoscopical and fluoroscopical guidance. Stent insertion was successful in all cases and led to immediate relief of the morphological and functional airway obstruction. No immediate complications were noted. During the mean follow-up period of 67.5 weeks we observed one recurrent dyspnea 3 months after implantation and granuloma formation at the stent insertion site in another patient. Both complications were successfully treated with additional stent insertion in one case and laser resection of granulomas in the other. Self-expanding nitinol stents should be considered for the treatment of benign proximal tracheal obstruction in selected patients for whom surgical repair is contraindicated.

  12. Insertion of Self-Expandable Nitinol Stents Without Previous Balloon Angioplasty Reduces Restenosis Compared with PTA Prior to Stenting

    SciTech Connect

    Harnek, Jan; Zoucas, Evita; Stenram, Unne; Cwikiel, Wojciech

    2002-10-15

    Purpose: To compare the development of intimal hyperplasia after deployment of a self-expanding nitinol stent with and without previous percutaneous transluminal balloon angioplasty (PTA), with the results after PTA alone. Methods: In nine healthy pigs, the iliac arteries were divided into three groups: group 1 (n = 6 arteries) was treated with PTA; group 2 n 6)with insertion of self-expanding stents after PTA; and group 3 (n = 6) with stent insertion without previous PTA. After 8 weeks the vessels were examined with intravascular ultrasonography,histologic examination and morphometric analysis. Results: Although the injury index in group 1 (0.17{+-} 0.57) was lower (p <0.05) than in group 2 (0.26 {+-} 0.06) and group 3 (0.26 {+-} 0.08), PTA-treated arteries showed significantly (p <0.05) reduced mean luminal gain (0.53 {+-} 2.84) compared with arteries treated with PTA prior to stenting (2.58 {+-} 1.38) and compared with stenting alone (4.65 {+-}5.34). Stenting after PTA resulted in a higher (p<0.05) restenosis index (2.63 {+-} 1.06) compared with stenting without PTA (1.35 {+-} 0.59). Group 2 also had a significantly thicker intimap <0.05) and 83% and 74% higher intima/mediaratio (p <0.05) compared with groups 1 and 3, respectively. Conclusion: Insertion of a self-expandable nitinol stent without previous PTA results in less intimalhyperplasia than if PTA is performed prior to stenting, suggesting that direct stenting can be used in angioplasty sessions with a favorable outcome.

  13. Radial forces of stents used in thoracic endovascular aortic repair and bare self-expanding nitinol stents measured ex vivo - Rapid rescue for obstruction of the innominate artery using bare self-expanding nitinol stents.

    PubMed

    Matsumoto, Takuya; Inoue, Kentaro; Tanaka, Shinichi; Aoyagi, Yukihiko; Matsubara, Yutaka; Matsuda, Daisuke; Yoshiya, Keiji; Yoshiga, Ryosuke; Ohkusa, Tomoko; Maehara, Yoshihiko

    2017-02-01

    Purpose Our objective was to compare the radial forces of several stents ex vivo to identify stents suitable for rescue of the unexpected coverage of aortic arch branches in thoracic endovascular aortic repair. Methods We measured the radial forces of two types of self-expanding bare nitinol stents (E-luminexx and Epic) used singly or as double-walled pairs, and of three endoprostheses used in thoracic endovascular aortic repair (TEVAR, Gore c-TAG, Relay, and Valiant) by compressing the stent using an MTS Instron universal testing machine (model #5582). We also examined the compressive effects of the TEVAR endoprostheses and the bare nitinol stents on each other. Results The radial force was greater in the center than at the edge of each stent. In all stents tested, the radial force decreased incrementally with increasing stent diameter. The radial force at the center was two times greater when using two stents than with a single stent. In the compression test, only E-luminexx used as a pair was not compressed after compressing a Relay endoprosthesis by 12 mm. Conclusion Two E-luminexx stents are appropriate to restore the blood flow if a TEVAR endoprosthesis covers the innominate artery following innominate-carotid-left subclavian arterial bypass.

  14. Feasibility study for the investigation of Nitinol self-expanding stents by neutron techniques

    NASA Astrophysics Data System (ADS)

    Rogante, M.; Pasquini, U.; Rosta, L.; Lebedev, V.

    2011-02-01

    In this paper, neutron techniques - in particular, small angle neutron scattering (SANS) and neutron diffraction (ND) - are considered for the non-destructive characterization of Nitinol artery stents. This roughly equiatomic (50Ni-50Ti at%) shape memory alloy (SMA) exhibits significant properties of superelasticity and biocompatibility that make it suitable to be typically used as smart material for medical implants and devices. Nitinol self-expanding artery stents, as permanent vascular support structures, supply an ideal option to bypass surgery, but they are submitted for the whole of patient's life to the dynamical stress of the artery pulsation and the aggression from the biological environment. These stents, consequently, can suffer from wear and fracture occurrence likely due to a variety of cyclic fatigue, overload conditions and residual stresses. Neutrons have recently become a progressively more important probe for various materials and components and they allow achieving information complementary to those obtained from the traditional microstructural analyses. The outputs from the preliminary works already carried out in this field consent to consider neutron techniques capable to contribute to the development of these crucial medical implants. The achievable results can yield trends adoptable in monitoring of the stent features.

  15. The Safety and efficacy of a new self-expandable intratracheal nitinol stent for the tracheal collapse in dogs

    PubMed Central

    Kim, Joon-young; Han, Hyun-jung; Yun, Hun-young; Lee, Bora; Jang, Ha-young; Eom, Ki-dong; Park, Hee-myung

    2008-01-01

    To evaluate the potential utility of a self-expandable intratracheal nitinol stent with flared ends for the treatment of tracheal collapse in dogs, endotracheal stenting therapy was performed under fluoroscopic guidance in four dogs with severe tracheal collapse. During the 4 to 7 month follow-up, after stent implantation, clinical signs, including dyspnea and respiratory distress, dramatically improved in all dogs. The radiographs showed that the implanted stents improved the tracheal collapse, and there were no side effects such as collapse, shortening or migration of the stents. In conclusion, the self-expandable intratracheal nitinol stents provided adequate stability to the trachea and were effective for attenuating the clinical signs associated with severe tracheal collapse. PMID:18296893

  16. Bleeding after expandable nitinol stent placement in patients with esophageal and upper gastrointestinal obstruction: incidence, management, and predictors.

    PubMed

    Oh, Se Jin; Song, Ho-Young; Nam, Deok Ho; Ko, Heung Kyu; Park, Jung-Hoon; Na, Han Kyu; Lee, Jong Jin; Kang, Min Kyoung

    2014-11-01

    Placement of self-expandable nitinol stents is useful for the treatment of esophageal and upper gastrointestinal (GI) obstruction. However, complications such as stent migration, tumor overgrowth, and bleeding occur. Although stent migration and tumor overgrowth are well documented in previous studies, the occurrence of bleeding has not been fully evaluated. To evaluate the incidence, management strategies, and predictors of bleeding after placement of self-expandable nitinol stents in patients with esophageal and upper GI obstruction. We retrospectively reviewed the medical records and results of computed tomography and endoscopy of 1485 consecutive patients with esophageal and upper GI obstructions who underwent fluoroscopically guided stent placement. Bleeding occurred in 25 of 1485 (1.7%) patients 0 to 348 days after stent placement. Early stent-related bleeding occurred in 10 patients (40%) and angiographic embolization was used for 5/10. Late bleeding occurred in 15 patients (60%) and endoscopic hemostasis was used for 7/15. Twenty-two of 25 (88%) patients with bleeding had received prior radiotherapy and/or chemotherapy. Bleeding is a rare complication after placement of expandable nitinol stents in patients with esophageal and upper GI obstruction, but patients with early bleeding may require embolization for control. Care must be exercised on placing stents in patients who have received prior radiotherapy or chemotherapy. © The Foundation Acta Radiologica 2013 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

  17. Fatigue-Life Computational Analysis for the Self-Expanding Endovascular Nitinol Stents

    NASA Astrophysics Data System (ADS)

    Grujicic, M.; Pandurangan, B.; Arakere, A.; Snipes, J. S.

    2012-11-01

    Self-expanding endovascular stents made of Nitinol (a Ni-Ti intermetallic compound possessing superelastic and shape-memory properties) are being widely used to treat a common circulatory problem in which narrowed arteries, primarily due to fatty deposits, hamper blood flow to the extremities (the problem commonly referred to as "peripheral artery disease"). The stents of this type unfortunately occasionally fail structurally (and, in turn, functionally) rendering the stenting procedure ineffective. The failure is most often attributed to the fatigue-induced damage since over its expected ten-year life span, the stent will normally experience 370-400 million pulsating-blood flow-induced loading cycles. Redesign/redevelopment of the stents using the conventional make-and-test approaches is quite expensive and time consuming and therefore is being increasingly complemented by computational engineering methods and tools. In the present study, advanced structural and fluid-structure interaction finite element computational methods are combined with the advanced fatigue-based durability analysis techniques to further enhance the use of the computational engineering analysis tools in the development of vascular stents with improved high-cycle fatigue life.

  18. Use of self-expanding nitinol stents in the pediatric management of refractory esophageal caustic stenosis.

    PubMed

    Alonso, Verónica; Ojha, Devicka; Nalluri, Harsha; de Agustín, Juan Carlos

    2017-10-01

    The treatment of recurrent esophageal stricture secondary to the ingestion of a caustic agent is an arduous task. Self-expanding esophageal stents may be an alternative to repeated endoscopic esophageal dilations. We present the case of a two-year-old male with a severe and long esophageal stricture successfully treated by the combination of dilations and stent placement. After five months of serial pneumatic dilations, three self-expanding nitinol stents internally coated with silicone were introduced through a gastrostomy, covering the entire esophagus. The procedure was performed under endoscopic and radiological guidance. Three months later, the treatment was repeated with a single stent. A new stenosis in the proximal esophagus required surgical resection, and anastomosis followed by two pneumatic dilations for five months resulted in longer intervals where the patient was asymptomatic. The results obtained were satisfactory, allowing the patient to conserve and use his own esophagus. However, this is a unique case and the optimal maintenance time and withdrawal time of the stent must be determined.

  19. Primary nitinol stenting for femoropopliteal disease.

    PubMed

    Mewissen, Mark W

    2009-04-01

    The 1- to 2-year primary patency rates associated with self-expanding nitinol stents for the treatment of symptomatic femoropopliteal disease are superior to those for percutaneous transluminal angioplasty (PTA) and the first-generation stainless steel balloon-expandable stents. The advantages of nitinol stents include improved radial strength and flexibility, the ability to recover from being crushed, reduced foreshortening, and (importantly) deployability without balloon dilation of the stent edge (which may decrease the incidence of the edge stenosis, or "candy-wrap" effect, often observed with balloon-expandable stents). The technical success rate associated with primary deployment of nitinol stents is very high, and acute to 6-month patency results are predictably excellent. Prior to the introduction of nitinol stents, the original guidelines (2000) of the multidisciplinary TransAtlantic Inter-Society Consensus (TASC I) recommended only an adjunctive role for femoropopliteal stents following suboptimal PTA. The abbreviated 2007 TASC II report essentially extended this recommendation to nitinol stents. Here, current trials of nitinol stenting in the femoropopliteal segment are discussed, with emphasis on the advantages of primary (and often direct) deployment in selected circumstances dependent on factors including lesion length, lesion location, indication for treatment (critical limb ischemia or claudication, in-stent restenosis, stent-graft restenosis), and the relative appropriateness of other modalities (e.g., covered stents). Technical considerations in primary nitinol stenting are briefly reviewed. Open questions regarding the factors involved in nitinol stent fracture and the possible association of fracture and restenosis are examined in the context of current clinical trials. A new generation of femoropopliteal nitinol stents combining superior durability and flexibility is expected soon. Development and implementation of uniform reporting and

  20. Endovascular Treatment of Peripheral Artery Disease with Expanded PTFE-Covered Nitinol Stents: Interim Analysis from a Prospective Controlled Study

    SciTech Connect

    Duda, S.H.; Bosiers, M.; Pusich, B.; Huettl, K.; Oliva, V.; Mueller-Huelsbeck, S.; Bray, A.; Luz, O.; Remy, C.; Hak, J.B.; Beregi, J.-P.

    2002-10-15

    Purpose: Current covered peripheral stent designs have significant drawbacks in terms of stent delivery characteristics and flexibility. The aim of this study was to analyze the technical performance, safety and initial clinical efficacy of expanded polytetrafluoroethylene (PTFE)-covered nitinol stents for arteriosclerotic peripheral artery disease. Methods:Eighty-two patients underwent implantation of PTFE-covered nitinol stents for iliac and/or femoral obstructions. The study was conducted prospectively in seven European centers and one Canadian center. Patients were controlled clinically and by duplex ultrasound follow-up. Data up to discharge were collected in 79 patients. Seventy-four patients have thus far received 1 month follow-up and 32 patients, 6 month follow-up examinations. Results: The average lesion length measured 47 mm for the common and external iliac arteries and 50 mm for the femoral arteries. The mean severity of the stenoses was reduced from 94% to 4% in the iliac arteries and from 98% to 7% in the femoral arteries after stent placement and dilatation. One device deviation (inadvertent stent misplacement) and one puncture-related severe adverse event with formation of a pseudoaneurysm occurred. There were occlusions of the stent in five patients. No infections were noticed. Conclusion: The interim analysis of this trial using PTFE-covered nitinol stents indicates that a strategy using primary implantation of this stent type is technically feasible, has an acceptable safety profile and is effective from a short-term perspective.

  1. The first clinical experience with a peripheral, self-expanding nitinol stent in the treatment of saphenous vein graft disease: angiographic evidence of late expansion.

    PubMed

    Bokhari, Syed W; Vahdat, Omid; Winters, Rex J

    2003-07-01

    The ideal intervention for degenerated saphenous vein grafts (SVG) is still controversial. We report the first use of a peripheral, self-expanding nitinol stent in the treatment of a patient with symptomatic SVG disease. The procedure was well tolerated, without any short- or long-term complications. Quantitative coronary analysis of a 3-month follow-up angiogram revealed a continued expansion of the nitinol stent. Larger scale trials are warranted to evaluate whether the self-expanding nitinol stents can be used alone or in adjunct to other modalities for the treatment of SVG disease. The case report is followed by a literature review of SVG stenting.

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

    PubMed

    Song, Ho-Young; Park, Hyungkeun; Suh, Tae-Suk; Ko, Gi-Young; Kim, Tae-Hyung; Kim, Eun-Sang; Park, Taehan

    2003-02-01

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

  3. [Pyeloureteral stenting using nitinol stents].

    PubMed

    Guliev, B G; Zagazezhev, A M

    2016-11-01

    To test the effectiveness of nitinol stents in restoring patency of pyeloureteral segment (PUS). Endoureteral nitinol stents were used in 54 patients. The indications for stenting were recurrent strictures of upper urinary tract and ureteral tumor obstruction in 34 and 20 patients, respectively. In 9 (16.6%) of them, including 4 women and 5 men aged 28-65 years, stenting was performed for extensive recurrent PUS strictures. In 8 patients extensive strictures resulted from various surgical interventions on the PUS. In 2 patients, PUS narrowing was caused by open pyelolithotomy, in 6 patients by pyeloplasty, both open (4) and laparoscopic (2). A female patient with solitary right kidney and Bourneville - Pringle disease of the PUS received two metal prostheses. In all cases, nitinol stents were adequately installed in PUS. Hematuria was observed in 1 patient. During the follow-up period of 8 to 60 months, the results of stenting were considered good in 6 (66.7%) and satisfactory in 2 (22.2%) patients. At month 10, 1 (11.1%) patient developed the stent obstruction by proliferative tissue and underwent ureteroscopy with recanalization of the nitinol stent. The patient with Bourneville - Pringle disease was found to have a stone formed in the renal pelvic end of the endoprosthesis; she underwent percutaneous nephrolithotripsy. In another patient a lower calyceal stone migrated and wedged into the proximal end of the stent. The stone was extracted using percutaneous nephroscopy. Pyeloureteral stenting is an effective method to restore patency of the PUS in patients with extensive recurrent strictures. For adequate functioning of the stents, they need to be of optimal length and correctly installed.

  4. ALD mediated heparin grafting on nitinol for self-expanded carotid stents.

    PubMed

    Wang, Fei; Zhang, Yan; Chen, Xiumian; Leng, Bing; Guo, Xin; Zhang, Tao

    2016-07-01

    Carotid-artery atherosclerosis is a common cause of ischemic stroke. Carotid-artery stenting (CAS) is one of the most effective treatments. However, In-stent restenosis (ISR) and re-endothelialization delay are two major issues of intravascular stent which affect clinical safety and reduce effects. In this study, atomic layer deposition (ALD) technology was applied to deposit a layer (10nm) of Al2O3 on Nitinol surface as an intermediate functional layer. The alumina covered surface was then modified with a coupling agent 3-aminopropyltriethoxysilane (APS) and heparin sequentially in order to improve the hemocompatibility of Nitinol stents. The successful graft of APS and heparin onto Nitinol was proven by X-ray photoelectron spectroscopy. Furthermore, the predicted improvement in the biocompatibilities of modified Nitinol was confirmed by water contact angle measurement, protein adsorption, platelet adhesion, and plasma recalcification time determination. The results of hemolysis assay, cell proliferation and cytotoxicity tests revealed that the grafting of heparin on NiTi kept the original positive performance of nitinol material. The results indicate that ALD technology is of great potential for the manufacture of medical devices, especially for surface modifications and functionalization. ALD technology can help with modifications of inert metallic surfaces and therefore benefit implantable medical devices, especially intravascular stents.

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

    SciTech Connect

    Gandini, Roberto; Konda, Daniel Tisone, Giuseppe; Pipitone, Vincenzo; Anselmo, Alessandro; Simonetti, Giovanni

    2005-12-15

    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 of bilioptysis and confirmed the complete exclusion of the bronchobiliary fistula.

  6. Endovascular Treatment for Infra-inguinal Autologous Saphenous Vein Graft Occlusion Using Self Expanding Nitinol Stents.

    PubMed

    Yanagiuchi, T; Kimura, M; Shiraishi, J; Sawada, T

    2016-01-01

    For patients with infra-inguinal autologous vein bypass graft occlusion, conventional open surgical repair or endovascular treatment (EVT) for native vessel occlusion have generally been performed. A 73 year old female with non-healing ulcer and gangrene of the left lower leg was diagnosed as having infra-inguinal autologous saphenous vein graft occlusion. In this case, surgical repair such as patch angioplasty, interposition graft, or replacement graft did not seem promising because of repeated previous infection in the polytetrafluoroethylene (PTFE) vascular prosthesis and absence of available autologous vein due to past surgery. Moreover, there was no chance of crossing the native vessel, since the proximal superficial femoral artery (SFA) had already been resected. Thus, EVT was performed for the occluded autologous vein graft, implanting multiple self expanding bare nitinol stents throughout the vein graft achieving complete revascularization, good medium term patency, and dramatically improved wound healing. Endovascular recanalization using multiple bare stents could be an alternative treatment for infra-inguinal autologous vein graft occlusion.

  7. Endovascular Repair of Arterial Iliac Vessel Wall Lesions with a Self-Expandable Nitinol Stent Graft System

    PubMed Central

    Mensel, Birger; Kühn, Jens-Peter; Hoene, Andreas; Hosten, Norbert; Puls, Ralf

    2014-01-01

    Objective To assess the therapeutic outcome after endovascular repair of iliac arterial lesions (IALs) using a self-expandable Nitinol stent graft system. Methods Between July 2006 and March 2013, 16 patients (13 males, mean age: 68 years) with a self-expandable Nitinol stent graft. A total of 19 lesions were treated: nine true aneurysms, two anastomotic aneurysms, two dissections, one arteriovenous fistula, two type 1B endoleaks after endovascular aneurysm repair, one pseudoaneurysm, and two perforations after angioplasty. Pre-, intra-, and postinterventional imaging studies and the medical records were analyzed for technical and clinical success and postinterventional complications. Results The primary technical and clinical success rate was 81.3% (13/16 patients) and 75.0% (12/16), respectively. Two patients had technical failure due to persistent type 1A endoleak and another patient due to acute stent graft thrombosis. One patient showed severe stent graft kinking on the first postinterventional day. In two patients, a second intervention was performed. The secondary technical and clinical success rate was 87.5% (14/16) and 93.8% (15/16). The minor complication rate was 6.3% (patient with painful hematoma at the access site). The major complication rate was 6.3% (patient with ipsilateral deep vein thrombosis). During median follow-up of 22.4 months, an infection of the aneurysm sac in one patient and a stent graft thrombosis in another patient were observed. Conclusion Endovascular repair of various IALs with a self-expandable Nitinol stent graft is safe and effective. PMID:25119346

  8. Self-Expanding Nitinol Renal Artery Stents: Comparison of Safety and Efficacy of Bare Versus Polyzene-F Nanocoated Stents in a Porcine Model

    SciTech Connect

    Kurz, P.; Stampfl, U.; Christoph, P.; Henn, C.; Satzl, S.; Radeleff, B.; Berger, I.; Richter, G. M.

    2011-02-15

    Objective: To investigate the safety and efficacy of a Polyzene-F nanocoat on new low-profile self-expandable nitinol stents in minipig renal arteries. Materials and Methods: Ten bare nitinol stents (BNS) and 10 stents coated with a 50 nm-thin Polyzene-F coating were randomly implanted into renal arteries of 10 minipigs (4- and 12-week follow-up, 5 animals/group). Thrombogenicity, on-stent surface endothelialization, vessel wall injury, late in-stent stenosis, and peristrut vessel wall inflammation were determined by quantitative angiography and postmortem histomorphometry. Results: In 6 of 10 BNS, >50% stenosis was found, but no stenosis was found in stents with a nanothin Polyzene-F coating. Histomorphometry showed a statistically significant (p < 0.05) different average maximum luminal loss of 55.16% {+-} 8.43% at 12 weeks in BNS versus 39.77% {+-} 7.41% in stents with a nanothin Polyzene-F coating. Stents with a nanothin Polyzene-F coating had a significantly (p < 0.05) lower inflammation score after 12 weeks, 1.31 {+-} 1.17 versus 2.17 {+-} 0.85 in BNS. The results for vessel wall injury (0.6 {+-} 0.58 for Polyzene-F-coated stents; 0.72 {+-} 0.98 for BNS) and re-endothelialization, (1.16 {+-} 0.43 and 1.23 {+-} 0.54, respectively) were not statistically significant at 12-week follow-up. No thrombus deposition was observed on the stents at either follow-up time point. Conclusion: Nitinol stents with a nanothin Polyzene-F coating successfully decreased in-stent stenosis and vessel wall inflammation compared with BNS. Endothelialization and vessel wall injury were found to be equal. These studies warrant long-term pig studies ({>=}120 days) because 12 weeks may not be sufficient time for complete healing; thereafter, human studies may be warranted.

  9. Nitinol stent design - understanding axial buckling.

    PubMed

    McGrath, D J; O'Brien, B; Bruzzi, M; McHugh, P E

    2014-12-01

    Nitinol׳s superelastic properties permit self-expanding stents to be crimped without plastic deformation, but its nonlinear properties can contribute towards stent buckling. This study investigates the axial buckling of a prototype tracheobronchial nitinol stent design during crimping, with the objective of eliminating buckling from the design. To capture the stent buckling mechanism a computational model of a radial force test is simulated, where small geometric defects are introduced to remove symmetry and allow buckling to occur. With the buckling mechanism ascertained, a sensitivity study is carried out to examine the effect that the transitional plateau region of the nitinol loading curve has on stent stability. Results of this analysis are then used to redesign the stent and remove buckling. It is found that the transitional plateau region can have a significant effect on the stability of a stent during crimping, and by reducing the amount of transitional material within the stent hinges during loading the stability of a nitinol stent can be increased.

  10. Five-year outcomes of self-expanding nitinol stent implantation for chronic total occlusion of the superficial femoral and proximal popliteal artery.

    PubMed

    Sakamoto, Yasunari; Hirano, Keisuke; Iida, Osamu; Soga, Yoshimitsu; Suzuki, Kenji; Muramatsu, Toshiya; Tsukahara, Reiko

    2013-09-01

    To investigate the 5-year patency rates and predictors of restenosis after self-expanding nitinol stent implantation for chronic total occlusion (CTO) in superficial femoral and proximal popliteal artery (SFPA) lesions. Outcomes and long-term patency rates after self-expanding nitinol stent for CTO in the SFPA lesions have not been clarified. From January 2004 to December 2009, 861 serial arteriosclerosis obliterans patients, 1,017 limbs, underwent endovascular therapy with implantation of a self-expanding nitinol stent for SFPA lesions at four institutions in Japan. Of the cohort, 352 patients, 383 limbs, had self-expanding nitinol stents implanted for CTOs in the SFPA and were followed for 5 years. We retrospectively investigated patency rate and multivariate predictors associated with restenosis. Mean age was 72 ± 9 years and 31% were female patients. In total, 58% of the patients had diabetes mellitus and 25% were patients with critical limb ischemia. Occluded length was 194 ± 89 mm, mean total stent length was 198 ± 7 mm, and mean stent diameter was 7.1 ± 0.9 mm. Five-year primary and secondary patency rates were 51.8 and 79.5%, respectively, and the rates of freedom from bypass surgery, major or minor amputation, and all-cause death were 96.1, 96.2, and 78.4%, respectively. Female gender (odds ratio, 1.95; P = 0.0051) and mean stent diameter (odds ratio, 0.77; P = 0.0324) were factors strongly associated with restenosis. Women and patients requiring small stents failed to maintain primary patency when treated with self-expanding nitinol stents for CTO lesions in the SFPA. Although primary patency was low, the secondary patency rate was acceptable. Copyright © 2013 Wiley Periodicals, Inc.

  11. Primary Self-EXPANDing Nitinol Stenting vs Balloon Angioplasty With Optional Bailout Stenting for the Treatment of Infrapopliteal Artery Disease in Patients With Severe Intermittent Claudication or Critical Limb Ischemia (EXPAND Study).

    PubMed

    Schulte, Karl-Ludwig; Pilger, Ernst; Schellong, Sebastian; Tan, Kong Ten; Baumann, Frederic; Langhoff, Ralf; Torsello, Giovanni; Zeller, Thomas; Amendt, Klaus; Brodmann, Marianne

    2015-10-01

    To compare primary placement of a self-expanding nitinol stent to percutaneous transluminal angioplasty (PTA) with bailout stenting in infrapopliteal arteries of patients with severe intermittent claudication or critical limb ischemia (CLI). In the EXPAND trial (ClinicalTrials.gov; identifier NCT00906022), 92 patients (mean age 72.9±9.5 years; 62 men) undergoing treatment for infrapopliteal stenosis in 11 European centers were randomized 1:1 to either self-expanding nitinol stenting with the Astron Pulsar/Pulsar-18 nitinol stent or PTA with bailout stenting. The primary endpoint was sustainable clinical improvement after 12 months, defined as a ≥1-category increase for Rutherford category 3 patients or a ≥2-category increase for CLI patients (Rutherford categories 4/5) compared with baseline. Furthermore, target lesion revascularization (TLR), mortality, and amputation were assessed after 12 months. Sustained clinical improvement at 1 year was observed in 74.3% of the patients treated with primary stenting and in 68.6% of the patients treated with PTA and bailout stenting (p>0.05). Kaplan-Meier estimates of freedom from TLR (76.6% and 77.6%), mortality (7.4% vs 2.1%), and amputation [8.9% (major 6.7%) vs 13.2% (major 8.7%)] at 1 year were not significantly different. Primary self-expanding nitinol stenting did not show statistically different clinical outcomes compared to angioplasty with bailout stenting for infrapopliteal lesions. © The Author(s) 2015.

  12. Chronic vascular response after self-expanding nitinol stent implantation in superficial femoral arteries: a serial intravascular ultrasound analysis.

    PubMed

    Nishimura, Machiko; Fujii, Kenichi; Fukunaga, Masashi; Kawasaki, Daizo; Miki, Kojiro; Saita, Ten; Horimatsu, Tetsuo; Tamaru, Hiroto; Imanaka, Takahiro; Naito, Yoshiro; Masuyama, Tohru

    2016-10-01

    The mechanical properties of the self-expanding nitinol stents (SENS) and chronic biological stimulation on the wall from the SENS have not been fully investigated. This study evaluated the mechanical vascular response to SENS implantation in superficial femoral artery (SFA) lesions using serial volumetric intravascular ultrasound (IVUS). Twenty-five symptomatic patients due to de novo SFA lesions scheduled for SENS placement were prospectively enrolled. Serial IVUS studies were performed immediately after crossing with a guidewire, immediately after the procedure, and at a 8-month follow-up. Serial IVUS volumetric analysis was conducted after stent deployment and at follow-up. Mean stent, lumen and neointimal areas were calculated as the volume divided by the stent length, and the calcium arc was measured. At follow-up, SENS had increased 40.6 % in overall volume. The chronic stent expansion tended to be larger, and the mean neointimal area at the 8-month follow-up was significantly larger in less calcified lesions compared to heavily calcified lesions. As a result, the mean late lumen area loss was significantly larger in lesions with calcium arcs of 0° and in the first and second quadrants than in those with calcium arcs in the third and fourth quadrants (2.8 ± 7.2, 1.3 ± 5.6, 0.6 ± 5.9, 1.2 ± 5.4, -0.8 ± 5.2 mm(2), respectively; p < 0.001). SENSs continued to enlarge with intimal proliferation over 8 months in all lesions. Although arterial calcium affected the degree of chronic stent expansion during the follow-up period, neointimal proliferation was smaller in heavily calcified lesion compared to less calcified lesion following SENS implantation.

  13. Comparing the vascular response in implantation of self-expanding, bare metal nitinol stents or paclitaxel-eluting nitinol stents in superficial femoral artery lesions: a serial optical frequency domain imaging study.

    PubMed

    Miki, Kojiro; Fujii, Kenichi; Shibuya, Masahiko; Fukunaga, Masashi; Imanaka, Takahiro; Tamaru, Hiroto; Nishimura, Machiko; Horimatsu, Tetsuo; Honda, Yasuhiro; Fitzgerald, Peter J; Masuyama, Tohru; Ishihara, Masaharu

    2016-12-20

    This study sought to investigate differences in vascular response between self-expanding bare metal nitinol stents (BMS) and paclitaxel-eluting nitinol stents (PES), in superficial femoral artery (SFA) disease, using optical frequency domain imaging (OFDI). Six months after stent implantation, follow-up quantitative vascular angiography (QVA) and OFDI assessment were scheduled to evaluate vascular response. Volume index (VI) was defined as volume divided by stent length. The primary endpoint was OFDI-derived late lumen area loss, defined as lumen VI post stent implantation minus lumen VI at follow-up. A total of 28 SFA lesions were analysed, with cases randomised to receive either BMS or PES implantation. QVA-derived diameter stenosis at six-month follow-up was lower in the PES group than in the BMS group (28.5% vs. 39.7%, p=0.04). After six months, BMS VI increased by 33.8% (20.7±3.7 to 27.7±3.5 mm3/mm), whilst PES exhibited an increase of 32.1% (19.0±2.3 to 25.1±4.7 mm3/mm). Neointimal VI was smaller (7.4±2.6 mm3/mm vs. 10.5±3.2 mm3/mm, p<0.01) and late lumen area loss was lower (2.9±1.3 mm3/mm vs. 5.6±2.8 mm3/mm, p<0.01) in the PES group. Serial volumetric OFDI analyses confirmed significantly smaller amounts of neointimal tissue and lower late lumen area loss following PES implantation for SFA lesions at short-term follow-up.

  14. Midterm to long-term safety and efficacy of self-expandable nitinol stent implantation for coarctation of aorta in adults.

    PubMed

    Haji Zeinali, Ali Mohammad; Sadeghian, Mohammad; Qureshi, Shakeel A; Ghazi, Payam

    2017-09-01

    Endovascular treatment of coarctation of aorta (CoA) by self-expandable Nitinol stents is one of the recognized treatment methods and may be an alternative to surgery or balloon-expandable stent implantation for CoA but there is little information about midterm to long term results of self-expandable stents. Sixty-two patients with CoA (40 men), with a mean age of 30.7 ± 11 years, (range 17-63 years) underwent stent implantation with Optimed self-expandable Nitinol stents between 2005 and 2014. Successful outcome was defined as peak systolic pressure gradient ≤20 mmHg after stent implantation. The patients were followed-up clinically and by echocardiography and in patients, in whom there was suspicion of recoarctation, CT angiography or recatheterization was performed. 65 stents were successfully implanted in all 62 patients. Peak systolic pressure gradient decreased from mean 62.4 ± 18 mmHg (range 35-100 mmHg) to mean 2.8 ± 5 mmHg (range 0-15 mmHg; P < 0.001). Stent displacement occurred in 3 patients during the procedure. These were managed successfully by an overlapping second stent. None of the patients had major complications such as aortic dissection, rupture, or vascular access problems. In follow up, only three patients had recoarctation, and two of these were managed successfully by balloon redilation or further stenting 16 and 18 months after the first procedure and one patient refused reintervention. There were two deaths, unrelated to the procedure, 12 and 78 months after the initial intervention. Follow-up of a mean of 45.5 ± 17 months (range 12-105 months) demonstrated no evidence of aneurysm formation or stent fracture. Self-expandable nitinol stents for the treatment of native and recurrent CoA is safe and has good efficacy with acceptable midterm to long-term outcome. © 2017 Wiley Periodicals, Inc.

  15. Self-expanding nitinol stents in recanalisation of long-length superficial femoral artery occlusions in patients with critical limb ischaemia.

    PubMed

    Taneja, M; Tay, K H; Sebastian, M; Pasupathy, S; Lin, S E; Teo, T; Low, R; Irani, F G; Chng, S P; Dewan, A; Tan, B S

    2009-12-01

    This study aims to evaluate our experience with self-expanding nitinol stent- enabled recanalisation of long-length occlusions (30 cm or more) of the superficial femoral artery (SFA). 573 patients underwent 842 lower limb interventions from August 2006 to December 2008. A retrospective review of patients undergoing recanalisation of long-length SFA occlusions with self-expanding nitinol stents and an evaluation of their patency and impact on limb salvage, were done. 22 patients (mean age 62.5 years, male: female ratio 11:11) underwent 22 long-length SFA stenting procedures. The spectrum of critical limb ischaemia included rest pain (five), ulcer (six) and gangrene (11). Length of occlusions varied from 30 cm to 45 cm (average length 36.4 cm). Five patients had stents placed through the ipsilateral popliteal artery approach, and the rest had stents placed through the femoral artery approach. All patients were followed up over an average duration of 12 months. One patient died due to associated medical conditions during this period. Six out of 21 (28.6 percent) of the stents thrombosed completely on one year follow-up. Of these, two patients underwent amputation, one patient had a bypass, and the stent in two patients were recanalised with balloon angioplasty. All remaining patent stents showed varying degrees of stenoses at one year. The overall limb salvage rate at one year following stent placement was 81 percent. Our experience showed the beneficial result of long-length SFA stent placement with good limb salvage outcome. Repeat interventions may be required to maintain the patency of stents in these patients.

  16. The New Nitinol Conformable Self-Expandable Metal Stents for Malignant Colonic Obstruction: A Pilot Experience as Bridge to Surgery Treatment

    PubMed Central

    2014-01-01

    Introduction. Self-expandable metal stents (SEMS) are a nonsurgical option for treatment of malignant colorectal obstruction also as a bridge to surgery approach. The new nitinol conformable stent has improved clinical outcomes in these kinds of patients. We report a pilot experience with nitinol conformable SEMS placement as bridge to surgery treatment in patients with colorectal obstruction. Materials and Methods. Between April and August 2012, we collected data on colonic nitinol conformable SEMS placement in a cohort of consecutive symptomatic patients, with malignant colorectal obstruction, who were treated as a bridge to surgery. Technical success, clinical success, and adverse events were recorded. Results. Ten patients (7 male (70%)), with a mean age of 69.2 ± 10.1, were evaluated. The mean length of the stenosis was 3.6 ± 0.6 cm. Five patients (50%) were treated on an emergency basis. The median time from stent placement to surgery was 16 days (interquartile range 7–21). Technical and clinical success was achieved in all patients with a significant early improvement of symptoms. No adverse events due to the SEMS placement were observed. Conclusion. This pilot study confirmed the important role of nitinol conformable SEMS as a bridge to surgery option in the treatment of symptomatic malignant colorectal obstruction. PMID:24526914

  17. The new nitinol conformable self-expandable metal stents for malignant colonic obstruction: a pilot experience as bridge to surgery treatment.

    PubMed

    Di Mitri, Roberto; Mocciaro, Filippo

    2014-01-01

    Self-expandable metal stents (SEMS) are a nonsurgical option for treatment of malignant colorectal obstruction also as a bridge to surgery approach. The new nitinol conformable stent has improved clinical outcomes in these kinds of patients. We report a pilot experience with nitinol conformable SEMS placement as bridge to surgery treatment in patients with colorectal obstruction. Between April and August 2012, we collected data on colonic nitinol conformable SEMS placement in a cohort of consecutive symptomatic patients, with malignant colorectal obstruction, who were treated as a bridge to surgery. Technical success, clinical success, and adverse events were recorded. Ten patients (7 male (70%)), with a mean age of 69.2±10.1, were evaluated. The mean length of the stenosis was 3.6±0.6 cm. Five patients (50%) were treated on an emergency basis. The median time from stent placement to surgery was 16 days (interquartile range 7-21). Technical and clinical success was achieved in all patients with a significant early improvement of symptoms. No adverse events due to the SEMS placement were observed. This pilot study confirmed the important role of nitinol conformable SEMS as a bridge to surgery option in the treatment of symptomatic malignant colorectal obstruction.

  18. Two-year Clinical Outcomes Post Implantation of Epic(TM) Self-Expanding Nitinol Stents for the Aortoiliac Occlusive Disease in Patients with Peripheral Arterial Disease.

    PubMed

    Tsujimura, Takuya; Iida, Osamu; Fujita, Masashi; Masuda, Masaharu; Okamoto, Shin; Ishihara, Takayuki; Nanto, Kiyonori; Kanda, Takashi; Okuno, Shota; Matsuda, Yasuhiro; Fujihara, Masahiko; Yokoi, Yoshiaki; Mano, Toshiaki

    2017-10-05

    We investigated 2-year clinical outcomes after implantaton of Epic(TM) self-expanding nitinol stents for patients with peripheral artery disease (PAD) due to the aortoiliac occlusive disease (AIOD). This study was a multicenter and retrospective study. From February 2013 through October 2014, 292 lesions (chronic total occlusion, 21%; TASC Ⅱ C/D, 35%) in 217 consecutive patients (74±8 years; male, 81%; diabetes mellitus, 47%; dialysis, 21%; critical limb ischemia, 29%) who had undergone endovascular therapy (EVT) with Epic(TM) self-expanding nitinol stents for PAD with AIOD were analyzed. The primary endpoints were 2-year primary patency and target lesion revascularization (TLR)-free rate. The primary patency and freedom from TLR were determined by Kaplan-Meier analysis. Additionally, predictors for loss of patency were estimated by Cox proportional hazard model. The mean follow-up duration was 19.1±8.5 months. Primary patency was 87.3% at 2 years. Freedom from TLR rate was 94.1% at 2 years. Multivariate analysis revealed that the presence of diabetes mellitus was associated with a loss of patency. The Epic(TM) self-expanding nitinol stent was demonstrated to be safe and effectivene for AIOD when tested for two years in patients with PAD.

  19. Safety and biocompatibility of a novel self-expanding nitinol carotid stent with hybrid cell design in a porcine model of neointimal hyperplasia.

    PubMed

    Janas, Adam; Milewski, Krzysztof; Buszman, Piotr P; Nowakowski, Przemysław; Jelonek, Michał; Orlik, Bartłomiej; Krauze, Agata; Samborski, Stefan; Beaudry, Diane; Lecelrc, Guy; Król, Marek; Lapointe, Jean Martin; Wojakowski, Wojciech; Turek, Anna; Kiesz, Radosław S; Buszman, Paweł E

    2015-01-01

    Stent design may influence the outcomes, suggesting that adverse event rates vary according to free cell area and cell design. Open cell design technology of self-expandable stents, dedicated for carotid revascularisation has better deliverability, although closed cell technology is expected to cause fewer thromboembolic events. To evaluate the feasibility and vascular response of novel, hybrid cell, self-expandable nitinol stents (MER®, Balton, Poland) implanted into porcine carotid arteries. Hybrid cell design combines open and closed cell technology. All tested stents were implanted with 10% overstretch into 10 carotid segments of Polish domestic pigs. Control angiography was obtained immediately before and after vascular interventions as well as 28 days after the procedure. Thereafter, animals were sacrificed, and the treated segments were harvested and evaluated in the independent histopathology laboratory. All stents were easily introduced and implanted, showing good angiographic acute outcome. At 28 days, in the angiography, all vessels were patent with no signs of thrombi or excessive neointimal formation, with the late lumen loss of -0.11 ± 0.3 mm and percentage diameter stenosis 10.18 ± 8.1%. There was a 10% increase in the vessel reference diameter when compared to baseline (4.57 ± 0.5 vs. 4.96 ± 0.3 mm, p < 0.01). In the histopathology, mean area stenosis was 17.4% and mean intimal thickness was 0.20 mm. At histopathology, the mean injury, inflammation, and fibrin scores were low. Endothelialisation was complete in all stents, and neointimal tissue appeared moderately mature as shown by the moderate mean neointimal smooth muscle score. Nonetheless, histopathology shows one stent affected by peri-strut granulomas and one stent affected by marked mineralisation. The novel Polish self-expandable nitinol carotid stent with hybrid cell technology shows optimal biocompatibility and a vascular healing profile, and therefore may be introduced for first

  20. Successful Endovascular Repair of an Iatrogenic Perforation of the Superficial Femoral Artery Using Self-Expanding Nitinol Supera Stents in a Patient with Acute Thromboembolic Limb Ischemia.

    PubMed

    Eisele, Tom; Muenz, Benedikt M; Korosoglou, Grigorios

    2016-01-01

    The treatment of acute thromboembolic limb ischemia includes well-established surgical thrombectomy procedures and, in recent times, also percutaneous rotational thrombectomy using Straub Rotarex® system. This modality not only enables efficient treatment of such thrombotic occlusion but also in rare cases may imply the risk of perforation of the occluded artery. Herein, we report the case of a perforation of the superficial femoral artery (SFA) in an elderly female patient with thromboembolic limb ischemia. The perforation was successfully treated by implantation of self-expanding nitinol Supera stents and without the need for implantation of a stent graft.

  1. Successful Endovascular Repair of an Iatrogenic Perforation of the Superficial Femoral Artery Using Self-Expanding Nitinol Supera Stents in a Patient with Acute Thromboembolic Limb Ischemia

    PubMed Central

    Eisele, Tom; Muenz, Benedikt M.

    2016-01-01

    The treatment of acute thromboembolic limb ischemia includes well-established surgical thrombectomy procedures and, in recent times, also percutaneous rotational thrombectomy using Straub Rotarex® system. This modality not only enables efficient treatment of such thrombotic occlusion but also in rare cases may imply the risk of perforation of the occluded artery. Herein, we report the case of a perforation of the superficial femoral artery (SFA) in an elderly female patient with thromboembolic limb ischemia. The perforation was successfully treated by implantation of self-expanding nitinol Supera stents and without the need for implantation of a stent graft. PMID:27213074

  2. Thin film nitinol covered stents: design and animal testing.

    PubMed

    Levi, Daniel S; Williams, Ryan J; Liu, Jasen; Danon, Saar; Stepan, Lenka L; Panduranga, Mohanchandra K; Fishbein, Michael C; Carman, Greg P

    2008-01-01

    Interventionalists in many specialties have the need for improved, low profile covered stents. Thin films of nitinol (<5-10 microns) could be used to improve current covered stent technology. A "hot target" sputter deposition technique was used to create thin films of nitinol for this study. Covered stents were created from commercially available balloon-inflatable and self-expanding stents. Stents were deployed in a laboratory flow loop and in four swine. Uncovered stent portions served as controls. Postmortem examinations were performed 2-6 weeks after implantation. In short-term testing, thin film nitinol covered stents deployed in the arterial circulation showed no intimal proliferation and were easily removed from the arterial wall postmortem. Scanning electron microscopy showed a thin layer of endothelial cells on the thin film, which covered the entire film by 3 weeks. By contrast, significant neointimal hyperplasia occurred on the luminal side of stents deployed in the venous circulation. Extremely low-profile covered stents can be manufactured using thin films of nitinol. Although long-term studies are needed, thin film nitinol may allow for the development of low-profile, nonthrombogenic covered stents.

  3. Comparison of drug-eluting balloon angioplasty with self-expanding interwoven nitinol stent deployment in patients with complex femoropopliteal lesions.

    PubMed

    Teymen, Burak; Akturk, Suleyman; Akturk, Ulku; Tdjani, Muhammed

    2017-01-01

    Objective The aim of this study was to compare the drug-eluting balloon with self-expanding interwoven nitinol stent deployment in patients with complex femoropopliteal lesions. Methods We retrospectively identified patients at our clinic with complex femoropopliteal artery lesions treated either with self-expanding interwoven nitinol stent or drug-eluting balloon. All patients had ankle-brachial index measured before and after the intervention, and regular clinical follow-up with Doppler ultrasonography was performed at six months and one year. Patients underwent peripheral angiography if needed. Results From April 2012 to July 2015, 107 patients with complex femoropopliteal lesions treated with using self-expanding interwoven nitinol stent ( N = 49, mean length 143.5 mm, mean follow-up of 14.1 ± 3.7 months) or drug-eluting balloon ( N = 58, mean length 140.6 mm, mean follow-up of 13.8 ± 4.1 months). The technical success rate was 100% in Supera® and 96.6% in drug-eluting balloon group. There were seven restenosis in self-expanding interwoven nitinol stent (SUS) group (84.8% patency) and 11 restenosis in drug-eluting balloon group (79.2% patency). A significant increase in the ankle-brachial index in both groups after intervention demonstrated a hemodynamic success (SUS group 0.45 ± 0.06, drug-eluting balloon group 0.43 ± 0.07). The mean Rutherford Becker Class significantly decreased in both groups after a follow-up of 12 months (SUS group 0.70 ± 0.73, drug-eluting balloon group 0.74 ± 0.75). Conclusion Deploying drug-eluting balloon or self-expanding interwoven nitinol stent in patients with complex femoropopliteal lesions are both safe and effective with high patency rates with no statistical difference for one-year primary patency rates between them.

  4. Nitinol Esophageal Stents: New Designs and Clinical Indications

    SciTech Connect

    Strecker, Ernst-Peter; Boos, Irene; Vetter, Sylvia; Strohm, Michael; Domschke, Sigurd

    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 stent 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.

  5. Novel use of a peripheral, self-expanding nitinol stent in adjunct to excimer laser coronary atherectomy in the treatment of degenerated vein graft disease.

    PubMed

    Gim, Ronald D; Bokhari, Syed W; Winters, Rex J

    2005-01-01

    Decades of successful surgical revascularization of coronary artery disease have led to a growing population with saphenous vein graft disease. However, the treatment of degenerated saphenous vein graft still remains controversial. We report a novel but successful use of a peripheral, self-expanding nitinol stent in adjunct to excimer laser coronary atherectomy (ELCA) in the treatment of symptomatic, degenerated saphenous vein graft disease. The procedure was tolerated well without any short- or long-term complications. The case report is followed by a review of the literature on the treatment of vein graft disease.

  6. Use of an ePTFE-covered nitinol self-expanding stent graft for the treatment off pre-closure device failure during transcatheter aortic valve replacement.

    PubMed

    Steinvil, Arie; Bernardo, Nelson; Rogers, Toby; Koifman, Edward; Buchanan, Kyle; Alraies, M Chadi; Shults, Christian; Torguson, Rebecca; Okubagzi, Petros G; Pichard, Augusto D; Satler, Lowell F; Ben-Dor, Itsik; Waksman, Ron

    2017-03-01

    Our aim was to describe our experience with the use of an ePTFE-covered nitinol self-expanding stent graft (GORE® VIABAHN® Endoprosthesis, Gore Medical, USA) placed in the common femoral artery for the treatment of suture-mediated pre-closure device failure following transcatheter aortic valve replacement (TAVR). Access site-related vascular complications (VC) following sheath removal related to pre-closure device failure during TAVR are common and treatment options may vary. We performed an observational study on a series of consecutive patients who underwent TAVR between 2013 and 2015. Included were 25 patients at a mean (±SD) age of 82±9. Failure of the closure device resulted in overt bleeding in 19 patients, dissection or no flow in 5 patients, and angiographic pseudoaneurysm in 1. Overall 29 stents were deployed with diameters ranging from 8 to 11mm and a length of 50mm (26, 90%). All stent-graft deployments achieved complete hemostasis of the arteriotomy site and resulted in normal flow to the distal vessels. None of the patients required open surgical repair. The mean hemoglobin drop was 2.6±1.3g/dl. Blood transfusions were used in 15 (60%) patients. Acute kidney injury occurred in 4 (16%) patients, none of whom was treated with dialysis. Length of hospital stay was 9±5days. All patients survived during a 30-day follow-up period, and none had VC related to the stented site. The use of an ePTFE-covered Nitinol self-expanding stent graft is a feasible, safe, and effective treatment modality for access site-related VC following TAVR. The use of an ePTFE-covered nitinol self-expanding stent graft placed in the common femoral artery for the treatment of suture-mediated pre-closure device failure following transcatheter aortic valve replacement (TAVR) is described in 25 patients. Its use was found to be feasible, safe, and an effective treatment modality for access site-related vascular complications following TAVR. Copyright © 2016 Elsevier Inc. All

  7. Long-Term Primary Patency Rate After Nitinol Self-Expandable Stents Implantation in Long, Totally Occluded Femoropopliteal (TASC II C & D) Lesions.

    PubMed

    Elmahdy, Mahmoud Farouk; Buonamici, Piergiovanni; Trapani, Maurizio; Valenti, Renato; Migliorini, Angela; Parodi, Guido; Antoniucci, David

    2017-06-01

    Endovascular therapy for long femoropopliteal lesions using percutaneous transluminal balloon angioplasty or first-generation of peripheral stents has been associated with unacceptable one-year restenosis rates. However, with recent advances in equipment and techniques, a better primary patency rate is expected. This study was conducted to detect the long-term primary patency rate of nitinol self-expandable stents implanted in long, totally occluded femoropopliteal lesions TransAtlantic Inter-Society Census (TASC II type C & D), and determine the predictors of reocclusion or restenosis in the stented segments. The demographics, clinical, anatomical, and procedural data of 213 patients with 240 de novo totally occluded femoropopliteal (TASC II type C & D) lesions treated with nitinol self-expandable stents were retrospectively analysed. Of these limbs, 159 (66.2%) presented with intermittent claudication, while 81 (33.8%) presented with critical limb ischaemia. The mean-time of follow-up was 36±22.6 months, (range: 6.3-106.2 months). Outcomes evaluated were, primary patency rate and predictors of reocclusion or restenosis in the stented segments. The mean age of the patients was 70.9±9.3 years, with male gender 66.2%. Mean pre-procedural ABI was 0.45±0.53. One-hundred-and-seventy-five (73%) lesions were TASC II type C, while 65 (27%) were type D lesions. The mean length of the lesions was 17.9±11.3mm. Procedure related complications occurred in 10 (4.1%) limbs. There was no periprocedural mortality. Reocclusion and restenosis were detected during follow-up in 45 and 30 limbs respectively, and all were re-treated by endovascular approach. None of the patients required major amputation. Primary patency rates were 81.4±1.1%, 77.7±1.9% and 74.4±2.8% at 12, 24, and 36 months respectively. Male gender, severe calcification, and TASC II D lesion were independent predictors for reocclusion, while predictors of restenosis were DM, smoking and TASC II D lesions

  8. On the role of SMA modeling in simulating NiTinol self-expanding stenting surgeries to assess the performance characteristics of mechanical and thermal activation schemes.

    PubMed

    Saleeb, A F; Dhakal, B; Owusu-Danquah, J S

    2015-09-01

    The work is focused on a detailed simulation of the key stages involved in the NiTinol self-expanding stenting surgical procedure; i.e., crimping, deployment, SMA activation, as well as post-surgery steady-state cyclic behavior mimicking the systolic-to-diastolic pressure oscillations. To this end, a general multi-mechanism SMA model was utilized, whose calibration was completed using the test data from simple isothermal uniaxial tension experiments. The emphasis in the study was placed on the comparison of two alternative SMA activation protocols, in terms of both the immediate and long-term (post-surgery) performance characteristics. The first is 'hard' mechanical activation utilizing superelasticity, and the second is 'soft' thermal activation relying upon the combined one-way shape memory effect and constrained-recovery characteristics of the NiTinol material. The important findings are (1) the thermal activation protocol is far superior compared to the mechanical counterpart, from the point of view of lower magnitudes of the induced outward chronic forces, lesser developed stresses in the host tissue, as well as higher compression ratio with lesser crimping force for the same geometry of initial stent memory configuration, (2) the thermal activation protocol completely bypassed the complications of maintaining the high restraining force during deployment of the stent, and (3) there is no indication of any detrimental functional fatigue/degradation in the cured stenotic artery during cyclic pressure oscillations.

  9. Treatment for long-segment femoro-popliteal obstructions: initial experience with a 4-F compatible self-expanding nitinol stent and review of the literature.

    PubMed

    Baumann, F; Do, D-D; Willenberg, T; Baumgartner, I; Diehm, N

    2012-08-01

    The aim of this paper was to evaluate the efficacy of a novel 4-F compatible self-expanding Nitinol stent for the treatment of long femoro-popliteal obstructions. This retrospective analysis includes patients with femoro-popliteal obstructions ≥ 120 mm in length, treated with a novel Nitinol stent (Pulsar-18) between February 2010 and December 2011. Patients were categorized as either intermittent claudication (IC) or critical limb ischemia (CLI). Primary endpoint was primary patency, secondary endpoints were target lesion revascularization (TLR). A total of 31 patients (IC: N=18 and CLI: N=13) were included in the present series. Mean age was 73.3 ± 10.1 years and 71% (22/31) of the patients were male. Primary intervention was performed in 77.4% (24/31) of the patients and re-do revascularization in the remaining. Mean lesion length of femoro-popliteal obstructions was 163.5 ± 32.5 mm. Technical success was obtained in all patients. Mean follow-up duration was 316 ± 198 days. Primary patency rates were 83.3% in IC and 80.0% in CLI patients at 6 months and 64.1% and 54.9% at 12 months, respectively (P=0.84). Target lesion revascularization occurred in 5.6% of IC and 20.0% of CLI patients at 6 months and in 14.1% and 36.0% at 12 months, respectively (P=0.43). Endovascular stenting of long femoro-popliteal lesions using the Pulsar-18 stent provides acceptable results with patency and restenosis rates comparable with data from literature for stenting of long femoro-popliteal obstructions.

  10. Covered versus uncovered self-expandable nitinol stents in the palliative treatment of malignant distal biliary obstruction: results from a randomized, multicenter study.

    PubMed

    Kullman, Eric; Frozanpor, Farshad; Söderlund, Claes; Linder, Stefan; Sandström, Per; Lindhoff-Larsson, Anna; Toth, Ervin; Lindell, Gert; Jonas, Eduard; Freedman, Jacob; Ljungman, Martin; Rudberg, Claes; Ohlin, Bo; Zacharias, Rebecka; Leijonmarck, Carl-Eric; Teder, Kalev; Ringman, Anders; Persson, Gunnar; Gözen, Mehmet; Eriksson, Olle

    2010-11-01

    Covered biliary metal stents have been developed to prevent tumor ingrowth. Previous comparative studies are limited and often include few patients. To compare differences in stent patency, patient survival, and complication rates between covered and uncovered nitinol stents in patients with malignant biliary obstruction. Randomized, multicenter trial conducted between January 2006 and October 2008. Ten sites serving a total catchment area of approximately 2.8 million inhabitants. A total of 400 patients with unresectable distal malignant biliary obstruction. ERCP with insertion of covered or uncovered metal stent. Follow-up conducted monthly for symptoms indicating stent obstruction. Time to stent failure, survival time, and complication rate. The patient survival times were 116 days (interquartile range 242 days) and 174 days (interquartile range 284 days) in the covered and uncovered stent groups, respectively (P = .320). The first quartile stent patency time was 154 days in the covered stent group and 199 days in the uncovered stent group (P = .326). There was no difference in the incidence of pancreatitis or cholecystitis between the 2 groups. Stent migration occurred in 6 patients (3%) in the covered group and in no patients in the uncovered group (P = .030). Randomization was not blinded. There were no significant differences in stent patency time, patient survival time, or complication rates between covered and uncovered nitinol metal stents in the palliative treatment of malignant distal biliary obstruction. However, covered stents migrated significantly more often compared with uncovered stents, and tumor ingrowth was more frequent in uncovered stents. Copyright © 2010 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

  11. Cerebral Nitinol Stenting in Progressive Stroke and in Crescendo TIAs.

    PubMed

    Cohen-Inbar, Or; Amsalem, Yaaqov

    2015-11-01

    Acute ischemic stroke (AIS) is the third leading cause of death. Arterial stenosis is a common cause of stroke, with a high risk of recurrent stroke. Treatment guidelines for AIS and transient ischemic attack (TIA) are still under debate. Treatment guidelines for progressive stroke or crescendo TIAs do not exist. Percutaneous transluminal angioplasty and stenting (PTAS) is an increasingly attractive treatment option, whose efficacy is yet to be proven. However, stent placement poses both short- and long-term risks such as immediate ischemic events, in-stent stenosis, and stent breakage. Thus the choice of stent type is critical. We report our experience with the LEO + (Balt Extrusion, Montmorency, France) nitinol flexible self-expanding stent for the treatment of progressive cerebrovascular accident or crescendo TIAs. Twelve patients, presenting with a clinical picture of a crescendo TIA or progressive stroke in evolution not halted by optimal medical care, were treated. Patients had a corresponding major cerebral arterial narrowing and evidence of cerebral infarction on imaging. Patients were followed clinically and radiographically. Twelve patients 17 to 80 years of age were treated during the study period (20 months). Sixteen nitinol flexible self-expandable stents (LEO +) were placed. All patients showed moderate to substantial improvement in neurologic functions after the procedure. PTAS should be considered a treatment option in case of progressive stroke or crescendo TIAs coupled with appropriate anatomical findings. This may allow for a substantial improvement in functional and neurologic status. Georg Thieme Verlag KG Stuttgart · New York.

  12. Late Stent Expansion and Neointimal Proliferation of Oversized Nitinol Stents in Peripheral Arteries

    SciTech Connect

    Zhao, Hugh Q. Nikanorov, Alexander; Virmani, Renu; Jones, Russell; Pacheco, Erica; Schwartz, Lewis B.

    2009-07-15

    For peripheral endovascular intervention, self-expanding (SE) stents are commonly oversized in relation to target arteries to assure optimal wall apposition and prevent migration. However, the consequences of oversizing have not been well studied. The purpose of this study was to examine the effects of SE stent oversizing (OS) with respect to the kinetics of late stent expansion and the long-term histological effects of OS. Pairs of overlapped 8 x 28-mm Nitinol SE stents were implanted into the iliofemoral arteries of 14 Yucatan swine. Due to variations in target artery size, the stent-to-artery ratio ranged from 1.2:1 to 1.9:1. Lumen and stent diameters were assessed by quantitative angiography at the time of implantation. Following angiographic assessment at 6 months, stented arteries were perfusion-fixed, sectioned, and stained for histological analysis. Immediately following implantation, the stents were found to be expanded to a range of 4.7-7.1 mm, largely conforming to the diameter of the recipient target artery. The stents continued to expand over time, however, and all stents had enlarged to nearly their 8-mm nominal diameter by 6 months. The histological effects of OS were profound, with marked increases in injury and luminal area stenosis, including a statistically significant linear correlation between stent-to-artery ratio and area stenosis. In this experimental model of peripheral endovascular intervention, oversized Nitinol SE stents are constrained by their target artery diameter upon implantation but expand to their nominal diameter within 6 months. Severe OS (stent-to-artery ratio >1.4:1) results in a profound long-term histological response including exuberant neointimal proliferation and luminal stenosis.

  13. The Primary Patency and Fracture Rates of Self-Expandable Nitinol Stents Placed in the Popliteal Arteries, Especially in the P2 and P3 Segments, in Korean Patients

    PubMed Central

    Chang, Il Soo; Park, Sang Woo; Yun, Ik Jin; Hwang, Jae Joon; Lee, Song Am; Kim, Jun Seok; Chang, Seong-Hwan; Jung, Hong Geun

    2011-01-01

    Objective We wanted to evaluate the status of self-expandable nitinol stents implanted in the P2 and P3 segments of the popliteal artery in Korean patients. Materials and Methods We retrospectively analyzed 189 consecutive patients who underwent endovascular treatment for stenoocclusive lesions in the femoropopliteal artery from July 2003 to March 2009, and 18 patients who underwent stent placement in popliteal arterial P2 and P3 segments were finally enrolled. Lesion patency was evaluated by ultrasound or CT angiography, and stent fracture was assessed by plain X-rays at 1, 3, 6 and 12 months and annually thereafter. Results At the 1-month follow-up, stent fracture (Type 2) was seen in one limb (up to P3, 1 of 18, 6%) and it was identified in seven limbs at the 3-month follow-up (Type 2, Type 3, Type 4) (n = 1: up to P2; n = 6: P3). At the 6-month follow-up, one more fracture (Type 1) (up to P3) was noted. At the 1-year follow-up, there were no additional stent fractures. Just four limbs (up to P2) at the 2-year follow-up did not have stent fracture. The primary patency was 94%, 61% and 44% at 1, 3 and 6 months, respectively, and the group with stent implantation up to P3 had a higher fracture rate than that of the group that underwent stenting up to P2 (p < 0.05). Conclusion We suggest that stent placement up to the popliteal arterial P3 segment and over P2 in an Asian population can worsen the stent patency owing to stent fracture. It may be necessary to develop a stent design and structure for the Asian population that can resist the bending force in the knee joint. PMID:21430937

  14. Long-Term Outcomes of Self-Expandable Nitinol Stent Implantation With Intraluminal Angioplasty to Treat Chronic Total Occlusion in the Superficial Femoral Artery (TransAtlantic Inter-Society Consensus Type D Lesions).

    PubMed

    Matsumi, Junya; Ochiai, Tomoki; Tobita, Kazuki; Shishido, Koki; Sugitatsu, Kazuya; Mizuno, Shingo; Yamanaka, Futoshi; Murakami, Masato; Tanaka, Yutaka; Takahashi, Saeko; Akasaka, Takeshi; Saito, Shigeru

    2016-02-01

    To evaluate the long-term outcomes of self-expandable nitinol stent implantation with intraluminal angioplasty for chronic total occlusion (CTO) in the superficial femoral artery (SFA) of patients with TransAtlantic Inter-Society Consensus (TASC) D lesions. From 2004 to 2011, self-expandable nitinol stent implantation in SFA was performed successfully in 72 consecutive limbs of 68 patients with TASC D lesions. These patients were assessed for an average of 38.8 ± 25.6 months. The procedure was performed using a 0.014" or 0.018" guidewire and intraluminal angioplasty. Patients with hemodialysis constituted 20.6% of cases. The mean occlusion length was 244.6 ± 34.1 mm. A bidirectional approach was performed in 69.4% of cases. Primary patency rates were 77.9%, 71.9%, 67.2%, and 51.5% at 1 year, 2 years, 3 years, and 5 years, respectively. Secondary patency rates were 88.6%, 78.7%, 71.1%, and 56.0% at 1 year, 2 years, 3 years, and 5 years, respectively. Cox regression multivariate analysis for hemodialysis pertaining to loss of primary and secondary patency resulted in hazard ratio = 2.555 (95% confidence interval, 1.108-5.891; P=.03) for loss of primary patency and hazard ratio = 3.615 (95% confidence interval, 1.380-9.471; P=.01) for loss of secondary patency. Long-term patency of self-expandable nitinol intraluminal stent implantation with intraluminal angioplasty to treat CTO (TASC D) in SFA is promising. Hemodialysis was the only independent predictor for loss of primary and secondary patency.

  15. Point-of-care seeding of nitinol stents with blood-derived endothelial cells.

    PubMed

    Jantzen, Alexandra E; Noviani, Maria; Mills, James S; Baker, Katherine M; Lin, Fu-Hsiung; Truskey, George A; Achneck, Hardean E

    2016-11-01

    Nitinol-based vascular devices, for example, peripheral and intracranial stents, are limited by thrombosis and restenosis. To ameliorate these complications, we developed a technology to promote vessel healing by rapidly seeding (QuickSeeding) autologous blood-derived endothelial cells (ECs) onto modified self-expanding nitinol stent delivery systems immediately before implantation. Several thousand micropores were laser-drilled into a delivery system sheath surrounding a commercial nitinol stent to allow for exit of an infused cell suspension. As suspension medium flowed outward through the micropores, ECs flowed through the delivery system attaching to the stent surface. The QuickSeeded ECs adhered to and spread on the stent surface following 24-h in vitro culture under static or flow conditions. Further, QuickSeeded ECs on stents that were deployed into porcine carotid arteries spread to endothelialize stent struts within 48 h (n = 4). The QuickSeeded stent struts produced significantly more nitric oxide in ex vivo flow circuits after 24 h, as compared to static conditions (n = 5). In conclusion, ECs QuickSeeded onto commercial nitinol stents within minutes of implantation spread to form a functional layer in vitro and in vivo, providing proof of concept that the novel QuickSeeding method with modified delivery systems can be used to seed functional autologous endothelium at the point of care. © 2015 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 104B: 1658-1665, 2016.

  16. Nitinol stent insertion for post-pneumonectomy syndrome.

    PubMed

    Harney, M S; Lacy, P D; O'Neill, S; Walsh, M

    2001-11-01

    Post-pneumonectomy syndrome is an unusual condition, that can occur a variable period of time after a patient has had a pneumonectomy. Management of this syndrome has been described using a number of different techniques, often with considerable mortality. We present a case report where this condition was treated successfully by insertion of an expandable Nitinol stent. This is the first time this technique has been described to treat this condition, and we feel it may be the procedure of choice in managing these patients.

  17. Self-expanding metal stents in malignant esophageal obstruction: a comparison between two stent types.

    PubMed

    Schmassmann, A; Meyenberger, C; Knuchel, J; Binek, J; Lammer, F; Kleiner, B; Hürlimann, S; Inauen, W; Hammer, B; Scheurer, U; Halter, F

    1997-03-01

    Self-expanding metal stents are a promising alternative in the palliation of malignant esophageal obstruction, but the relative value of different stent types is not well established. During a 3-year enrollment period in four different centers, 82 consecutive patients with malignant dysphagia without tumor recurrence after surgery or esophagorespiratory fistulas received either an uncovered Wallstent (44 patients) or a knitted nitinol stent (38 patients). Age (median: 79 yr), sex (F:M = 33:67), dysphagia score (median: 3), Karnofsky score (median: 53), body mass index (median: 19), type of pretreatment, tumor stage, stricture length (median: 5.4 cm), and stricture location were comparable in both stent groups. After stent placement, median dysphagia score improved markedly in both groups by two points. Procedure-related mortality (16 vs 0%; p < 0.01), early complication rate (32 vs 8%; p < 0.01), and severe persistent pain after stent placement (23 vs 0%; p < 0.002) were higher in the Wallstent compared with the knitted nitinol stent group. In contrast, stent dysfunction (7 vs 32%; p < 0.005), reintervention rate (9 vs 34%; p < 0.005), and costs were lower in the Wallstent compared with the nitinol stent group. In malignant esophageal obstruction, both stents markedly improved dysphagia. Uncovered Wallstents seem to cause more early severe complications than knitted nitinol stents. In contrast, stent dysfunction, reintervention rate, and costs appear to be higher in the nitinol stent group.

  18. Computational Study of Axial Fatigue for Peripheral Nitinol Stents

    NASA Astrophysics Data System (ADS)

    Meoli, Alessio; Dordoni, Elena; Petrini, Lorenza; Migliavacca, Francesco; Dubini, Gabriele; Pennati, Giancarlo

    2014-07-01

    Despite their success as primary treatment for vascular diseases, Nitinol peripheral stents are still affected by complications related to fatigue failure. Hip and knee movements during daily activities produce large and cyclic deformations of the superficial femoral artery, that concomitant to the effects of pulsatile blood pressure, may cause fatigue failure in the stent. Fatigue failure typically occurs in cases of very extended lesions, which often require the use of two or more overlapping stents. In this study, finite element models were used to study the fatigue behavior of Nitinol stents when subjected to cyclic axial compression in different conditions. A specific commercial Nitinol stent was chosen for the analysis and subjected to cyclic axial compression typical of the femoral vascular region. Three different configurations were investigated: stent alone, stent deployed in a tube, and two overlapping stents deployed in a tube. Results confirm that stent oversizing has an influence in determining both the mean and amplitude strains induced in the stent and plays an important role in determining the fatigue response of Nitinol stents. In case of overlapping stents, numerical results suggest higher amplitude strains concentrate in the region close to the overlapping portion where the abrupt change in stiffness causes higher cyclic compression. These findings help to explain the high incidence of stent fractures observed in various clinical trials located close to the overlapping portion.

  19. Comparison of diamond-like carbon-coated nitinol stents with or without polyethylene glycol grafting and uncoated nitinol stents in a canine iliac artery model

    PubMed Central

    Kim, J H; Shin, J H; Shin, D H; Moon, M-W; Park, K; Kim, T-H; Shin, K M; Won, Y H; Han, D K; Lee, K-R

    2011-01-01

    Objective Neointimal hyperplasia is a major complication of endovascular stent placement with consequent in-stent restenosis or occlusion. Improvements in the biocompatibility of stent designs could reduce stent-associated thrombosis and in-stent restenosis. We hypothesised that the use of a diamond-like carbon (DLC)-coated nitinol stent or a polyethylene glycol (PEG)-DLC-coated nitinol stent could reduce the formation of neointimal hyperplasia, thereby improving stent patency with improved biocompatibility. Methods A total of 24 stents were implanted, under general anaesthesia, into the iliac arteries of six dogs (four stents in each dog) using the carotid artery approach. The experimental study dogs were divided into three groups: the uncoated nitinol stent group (n = 8), the DLC-nitinol stent group (n = 8) and the PEG-DLC-nitinol stent group (n = 8). Results The mean percentage of neointimal hyperplasia was significantly less in the DLC-nitinol stent group (26.7±7.6%) than in the nitinol stent group (40.0±20.3%) (p = 0.021). However, the mean percentage of neointimal hyperplasia was significantly greater in the PEG-DLC-nitinol stent group (58.7±24.7%) than in the nitinol stent group (40.0±20.3%) (p = 0.01). Conclusion Our findings indicate that DLC-coated nitinol stents might induce less neointimal hyperplasia than conventional nitinol stents following implantation in a canine iliac artery model; however, the DLC-coated nitinol stent surface when reformed with PEG induces more neointimal hyperplasia than either a conventional or DLC-coated nitinol stent. PMID:21325363

  20. Comparison of diamond-like carbon-coated nitinol stents with or without polyethylene glycol grafting and uncoated nitinol stents in a canine iliac artery model.

    PubMed

    Kim, J H; Shin, J H; Shin, D H; Moon, M-W; Park, K; Kim, T-H; Shin, K M; Won, Y H; Han, D K; Lee, K-R

    2011-03-01

    Neointimal hyperplasia is a major complication of endovascular stent placement with consequent in-stent restenosis or occlusion. Improvements in the biocompatibility of stent designs could reduce stent-associated thrombosis and in-stent restenosis. We hypothesised that the use of a diamond-like carbon (DLC)-coated nitinol stent or a polyethylene glycol (PEG)-DLC-coated nitinol stent could reduce the formation of neointimal hyperplasia, thereby improving stent patency with improved biocompatibility. A total of 24 stents were implanted, under general anaesthesia, into the iliac arteries of six dogs (four stents in each dog) using the carotid artery approach. The experimental study dogs were divided into three groups: the uncoated nitinol stent group (n = 8), the DLC-nitinol stent group (n = 8) and the PEG-DLC-nitinol stent group (n = 8). The mean percentage of neointimal hyperplasia was significantly less in the DLC-nitinol stent group (26.7±7.6%) than in the nitinol stent group (40.0±20.3%) (p = 0.021). However, the mean percentage of neointimal hyperplasia was significantly greater in the PEG-DLC-nitinol stent group (58.7±24.7%) than in the nitinol stent group (40.0±20.3%) (p = 0.01). Our findings indicate that DLC-coated nitinol stents might induce less neointimal hyperplasia than conventional nitinol stents following implantation in a canine iliac artery model; however, the DLC-coated nitinol stent surface when reformed with PEG induces more neointimal hyperplasia than either a conventional or DLC-coated nitinol stent.

  1. [Finite Element Analysis of Effect of Key Dimension of Nitinol Stent on Its Fatigue Behaviour].

    PubMed

    Li, Jianjun; Wang, Shengzhang

    2015-04-01

    To evaluate the fatigue behavior of nitinol stents, we used the finite element method to simulate the manufacture processes of nitinol stents, including expanding, annealing, crimping, and releasing procedure in applications of the clinical treatments. Meanwhile, we also studied the effect of the crown area dimension of stent on strain distribution. We then applied a fatigue diagram to investigate the fatigue characteristics of nitinol stents. The results showed that the maximum strain of all three stent structures, which had different crown area dimensions under vessel loads, located at the transition area between the crown and the strut, but comparable deformation appeared at the inner side of the crown area center. The cause, of these results was that the difference of the area moment of inertia determined by the crown dimension induced the difference of strain distribution in stent structure. Moreover, it can be drawn from the fatigue diagrams that the fatigue performance got the best result when the crown area dimension equaled to the intermediate value. The above results proved that the fatigue property of nitinol stent had a close relationship with the dimension of stent crown area, but there was no positive correlation.

  2. Large-bore nitinol stents for malignant superior vena cava syndrome: factors influencing outcome.

    PubMed

    Maleux, Geert; Gillardin, Patrick; Fieuws, Steffen; Heye, Sam; Vaninbroukx, Johan; Nackaerts, Kristiaan

    2013-09-01

    The purpose of this article is to retrospectively evaluate the technical and clinical outcomes of large-bore nitinol stents for treating malignant superior vena cava syndrome. In addition, we analyzed factors potentially influencing the outcome. Over a 7-year period, 78 consecutive patients presented with superior vena cava syndrome related to primary lung tumor (n=62) or malignant lymphadenopathies (n=16). The factors analyzed were Kishi score at admission, tumor type, and need for an additional balloon-expandable stent. Technical success was obtained in all but one patient (99%), who presented with a stent migration immediately after insertion. In 17 patients (22%), an additional balloon-expandable stent was needed for complete expansion of the nitinol stent. For patients with symptomatic malignant lymphadenopathies or primary lung tumor, overall survival rates were 50% (n=8) and 54% (n=34), respectively, at 6 months and 19% (n=3) and 34% (n=21), respectively, at 12 months (p=0.376). There was no difference in survival as a function of the Kishi score (p=0.80) or of the placement of an additional balloon-expandable stent (p=0.35). Finally, reocclusion events were noted in patients both with (n=1) and without (n=7) a balloon-expandable stent. Large-bore nitinol stents are highly effective for malignant superior vena cava syndrome. The survival rates of patients with caval vein stenosis due to either the primary tumor or secondary enlarged adenopathies were equal. An additional balloon-expandable stent was required in 22% of cases owing to incomplete expansion of the nitinol stent but was not associated with higher thrombosis rate.

  3. Prevalence, factors, and clinical impact of self-expanding stent fractures following iliac artery stenting.

    PubMed

    Higashiura, Wataru; Kubota, Yasushi; Sakaguchi, Shoji; Kurumatani, Norio; Nakamae, Mitsuhiro; Nishimine, Kiyoshi; Kichikawa, Kimihiko

    2009-03-01

    To evaluate the prevalence, factors, and clinical impact of self-expanding stent fracture following iliac artery stenting. A review of the endovascular registry database for our department showed 353 patients with occlusive diseases of the iliac artery who underwent stenting between 1997 and 2007. While clinical data and images were retrospectively reviewed for all patients, 165 patients who underwent self-expanding stenting and plain radiograph with >or=6-months follow-up were analyzed. Mean follow-up was 43 months for 305 stents (elgiloy, n = 83; nitinol, n = 222) implanted in 216 iliac arteries. The mean duration until the last imaging study was 38 months. Items concerning prevalence of stent fracture, factors associated with fracture, and outcomes for patients with stent fracture were analyzed. Stent fracture was detected in 11 of 216 iliac arteries (5.1%). In stent-based analysis, 11 of 305 stents (3.6%) showed stent fracture, classified as type I in 2 stents, type II in 3 stents, type III in 4 stents, type IV in 1 stent, and type V in 1 stent. Stent fracture was detected in 11 of 222 nitinol stents (5.0%), but no Elgiloy stents. Cox proportional hazards regression model indicated stenting for chronic occlusion as a risk factor associated with nitinol stent fracture (hazard ratio [HR] = 6.09, P = 0.008, 95% confidence interval [CI] 1.59-23.3). Cumulative primary patency rates in iliac arteries with and without fractured stents were 90% and 91% at 8 years (P = .80), respectively. Fracture of self-expanding stents is rare in iliac arteries, but stenting for chronic occlusion represents a risk factor for fracture. Fractures of stents placed in iliac arteries rarely affect patency.

  4. [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.

  5. Endotracheal nitinol stents: lessons from the learning curve.

    PubMed

    Siegel, Bianca; Bent, John P; Ward, Robert F

    2013-04-01

    To reflect on lessons learned placing endotracheal nitinol stents in children. Case series with chart review. Tertiary care children's hospital. All children who underwent nitinol cervical tracheal stenting were included. Records were carefully reviewed for intraoperative and postoperative complications, management choices, outcomes, and factors that influenced results. Between 1999 and 2011, 7 children underwent 13 stent placements. Median follow-up was 5 years (range, 1-12 years). Six patients underwent stenting as a salvage procedure following open attempts at airway reconstruction. Four patients remain decannulated with their stent in place (median follow-up 7 years). The fifth patient had his stent removed endoscopically after 50 days because it became apparent that his obstruction was primarily laryngeal. The sixth child had his stent removed via a tracheal fissure after 14 months because of recalcitrant subglottic inflammation at the superior stent border. The seventh patient was decannulated for over 2 years but ultimately required tracheotomy replacement because of stenosis with the stent lumen. Complications included stent migration (23%), restenosis (29%), edema (29%), and granulation (57%). Endotracheal nitinol stents provide a realistic opportunity for decannulation in children for whom other options have failed but should be reserved only as a salvage procedure in severely complicated airways. Our experience has taught valuable lessons about stent indications, sizing, characteristics, and deployment, as well as means to avoid and manage their complications.

  6. Fluorocopolymer-coated nitinol self-expanding paclitaxel-eluting stent: pharmacokinetics and vascular biology responses in a porcine iliofemoral model.

    PubMed

    Hou, Dongming; Huibregtse, Barbara A; Eppihimer, Michael; Stoffregen, William; Kocur, Gordon; Hitzman, Cory; Stejskal, Elizabeth; Heil, John; Dawkins, Keith D

    2016-08-20

    Our aim was to evaluate arterial responses to paclitaxel and a novel fluorocopolymer-coated nitinol low-dose paclitaxel-eluting stent (FP-PES). Human smooth muscle cell (SMC) migration was assessed after exposure to paclitaxel in vitro. For pharmacokinetics and vascular response, FP-PES or bare metal stents (BMS) were implanted in porcine iliofemoral arteries. Paclitaxel significantly inhibited human coronary and femoral artery SMC migration at doses as low as 1 pM. Inhibition was significantly greater for femoral compared with coronary artery SMCs from 1 pM to 1 μM. Pharmacokinetics showed consistent paclitaxel release from FP-PES over the study duration. The peak arterial wall paclitaxel level was 3.7 ng/mg at 10 days, with levels decreasing to 50% of peak at 60 days and 10% at 180 days. Paclitaxel was not detected in blood or remote organs. Arteriogram and histomorphometry analyses showed FP-PES significantly inhibits neointimal proliferation versus BMS at 30 and 90 days. Re-endothelialisation scores were not different between groups. Paclitaxel affected femoral artery SMC migration at lower concentrations and to a greater degree than it did coronary artery SMCs. The novel FP-PES used in this preclinical study demonstrated a vascular healing response similar to BMS, while significantly inhibiting neointimal formation up to 90 days.

  7. 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.

  8. The use of covered nitinol stents to salvage dialysis grafts after multiple failures.

    PubMed

    Naoum, Joseph J; Irwin, Chance; Hunter, Glenn C

    2006-01-01

    The increasing number of patients requiring hemodialysis and the limited number of access sites have resulted in an increase in multiple graft revisions to maintain access for hemodialysis. Venous outflow or anastomotic stenoses in vascular grafts tend to recur and contribute to the difficulty in maintaining a functioning graft. Thus, extending the life of a failed graft becomes an important objective of this study, which was to assess the use of covered nitinol stents to salvage expanded polytetrafluoroethylene (ePTFE) grafts with venous anastomotic or outflow stenosis that have failed after multiple revisions. This is a review of 8 failed non-autogenous ePTFE grafts with isolated venous anastomotic or proximal outflow stenoses that had undergone multiple previous revisions, had failed percutaneous transluminal angioplasty (PTA), and required placement of a covered nitinol stent. Graft locations were forearm (2), upper arm (4), and femoral (2). The mean number of interventions per patient before stent placement was 5.87 thrombectomies (range 2-28) and 3.38 balloon angioplasties (range 2-19). Five patients had 0.62 interposition grafting and 3 had patch angioplasty. All 8 patients (100%) underwent successful dialysis after thrombectomy and stenting. The primary and secondary patency rates after stent placement were 50% and 75%, and 25% and 75%, at 3 and 6 months, respectively. Percutaneous thrombectomy, balloon angioplasty, and concomitant covered nitinol stent placement extend the function of hemodialysis access grafts that have previously failed multiple times.

  9. On the Mechanical Properties and Microstructure of Nitinol forBiomedical Stent Applications

    SciTech Connect

    Robertson, Scott W.

    2006-01-01

    This dissertation was motivated by the alarming number of biomedical device failures reported in the literature, coupled with the growing trend towards the use of Nitinol for endovascular stents. The research is aimed at addressing two of the primary failure modes in Nitinol endovascular stents: fatigue-crack growth and overload fracture. The small dimensions of stents, coupled with their complex geometries and variability among manufacturers, make it virtually impossible to determine generic material constants associated with specific devices. Instead, the research utilizes a hybrid of standard test techniques (fracture mechanics and x-ray micro-diffraction) and custom-designed testing apparatus for the determination of the fracture properties of specimens that are suitable representations of self-expanding Nitinol stents. Specifically, the role of texture (crystallographic alignment of atoms) and the austenite-to-martensite phase transformation on the propagation of cracks in Nitinol was evaluated under simulated body conditions and over a multitude of stresses and strains. The results determined through this research were then used to create conservative safe operating and inspection criteria to be used by the biomedical community for the determination of specific device vulnerability to failure by fracture and/or fatigue.

  10. On the mechanical properties and microstructure of Nitinol for biomedical stent applications

    NASA Astrophysics Data System (ADS)

    Robertson, Scott Wade

    This dissertation was motivated by the alarming number of biomedical device failures reported in the literature, coupled with the growing trend towards the use of Nitinol for endovascular stents. The research is aimed at addressing two of the primary failure modes in Nitinol endovascular stents: fatigue-crack growth and overload fracture. The small dimensions of stents, coupled with their complex geometries and variability among manufacturers, make it virtually impossible to determine generic material constants associated with specific devices. Instead, the research utilizes a hybrid of standard test techniques (fracture mechanics and x-ray micro-diffraction) and custom-designed testing apparatus for the determination of the fracture properties of specimens that are suitable representations of self-expanding Nitinol stents. Specifically, the role of texture (crystallographic alignment of atoms) and the austenite-to-martensite phase transformation on the propagation of cracks in Nitinol was evaluated under simulated body conditions and over a multitude of stresses and strains. The results determined through this research were then used to create conservative safe operating and inspection criteria to be used by the biomedical community for the determination of specific device vulnerability to failure by fracture and/or fatigue.

  11. Comparison of partially covered nitinol stents with partially covered stainless stents as a historical control in a multicenter study of distal malignant biliary obstruction: the WATCH study.

    PubMed

    Isayama, Hiroyuki; Mukai, Tsuyoshi; Itoi, Takao; Maetani, Iruru; Nakai, Yousuke; Kawakami, Hiroshi; Yasuda, Ichiro; Maguchi, Hiroyuki; Ryozawa, Shomei; Hanada, Keiji; Hasebe, Osamu; Ito, Kei; Kawamoto, Hirofumi; Mochizuki, Hitoshi; Igarashi, Yoshinori; Irisawa, Atsushi; Sasaki, Tamito; Togawa, Osamu; Hara, Taro; Kamada, Hideki; Toda, Nobuo; Kogure, Hirofumi

    2012-07-01

    Covered self-expandable metal stents (CSEMSs) were developed to prevent tumor ingrowth, but stent migration is one of the problems with CSEMSs. To evaluate a new, commercially available CSEMS with flared ends and low axial force compared with a commercially available CSEMS without the anti-migration system and high axial force. Multicenter, prospective study with a historical cohort. Twenty Japanese referral centers. This study involved patients with unresectable distal malignant biliary obstruction. Placement of a new, commercially available, partially covered SEMS. Recurrent biliary obstruction rate, time to recurrent biliary obstruction, stent-related complications, survival. Between April 2009 and March 2010, 141 patients underwent partially covered nitinol stent placement, and between May 2001 and January 2007, 138 patients underwent placement of partially covered stainless stents as a historical control. The silicone cover of the partially covered nitinol stents prevented tumor ingrowth. There were no significant differences in survival (229 vs 219 days; P = .250) or the rate of recurrent biliary obstruction (33% vs 38%; P = .385) between partially covered nitinol stents and partially covered stainless stents. Stent migration was less frequent (8% vs 17%; P = .019), and time to recurrent biliary obstruction was significantly longer (373 vs 285 days; P = .007) with partially covered nitinol stents. Stent removal was successful in 26 of 27 patients (96%). Nonrandomized, controlled trial. Partially covered nitinol stents with an anti-migration system and less axial force demonstrated longer time to recurrent biliary obstruction with no tumor ingrowth and less stent migration. Copyright © 2012 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

  12. Neointimal Hyperplasia in Low-Profile Nitinol Stents, Palmaz Stents, and Wallstents: A Comparative Experimental Study

    SciTech Connect

    Schuermann, Karl; Vorwerk, Dierk; Kulisch, Arthur; Stroehmer-Kulisch, Eva; Biesterfeld, Stefan; Stopinski, Tadeusz; Guenther, Rolf W.

    1996-04-15

    Purpose: To compare neointima formation following insertion of low-profile Nitinol stents, Palmaz stents, and Wallstents. Methods: Nitinol stents, Palmaz stents, and Wallstents similar in size were transfemorally inserted into the iliac arteries of 12 sheep. Four stents per sheep were deployed; the position of the stents was varied so that each type of stent was placed in each position (right or left, proximal or distal) with equal frequency. Stent patency was followed by angiography. Six sheep were euthanized after 1 month, and the remaining six after 6 months. Iliac arteries were removed en bloc and prepared for histological examination. Neointimal and medial thickness were measured by light microscopy, and measurements were analyzed statistically. Results: Mean neointimal thickness both over (NO) and between (NB) the stent struts was greater in Wallstents (NO = 0.341 mm, NB = 0.368 mm) than in the Nitinol (NO = 0.260 mm, NB = 0.220 mm) and Palmaz stents (NO = 0.199 mm, NB = 0.204 mm), but differences were not significant (p> 0.05). Medial atrophy in the area between the stent struts was greater in Wallstents compared with Nitinol and Palmaz stents (p < 0.007 and p < 0.02, respectively); in the area under the stent struts there was a significant difference only between Palmaz stents and Wallstents (p < 0.02). Conclusion: Under defined experimental conditions, none of the three types of stent appears to be preferable to the others regarding neointima formation in the short- to mid-term follow-up period.

  13. Successful Exclusion of Subclavian Aneurysms with Covered Nitinol Stents

    SciTech Connect

    Szeimies, Ulrike; Kueffer, Georg; Stoeckelhuber, Beate; Steckmeier, Bernd

    1998-05-15

    Two cases of percutaneous endoluminal exclusion of a subclavian aneurysm with a Dacron-coated nitinol stent are presented. One subclavian aneurysm followed trauma; the other was due to thoracic outlet stenosis which was caused by a cervical rib. In both patients the aneurysm was excluded successfully. The follow-up periods were 22 and 14 months, respectively. Stenoses at the stent graft occurred in both patients; one was treated by balloon angioplasty. In selected patients, endoluminal grafting could be an alternative to surgery; however, stent graft designs need to be improved and long-term follow-up is awaited.

  14. Percutaneous Palliation of Pancreatic Head Cancer: Randomized Comparison of ePTFE/FEP-Covered Versus Uncovered Nitinol Biliary Stents

    SciTech Connect

    Krokidis, Miltiadis; Fanelli, Fabrizio; Orgera, Gianluigi; Tsetis, Dimitrios; Mouzas, Ioannis; Bezzi, Mario; Kouroumalis, Elias; Pasariello, Roberto; Hatzidakis, Adam

    2011-04-15

    The purpose of this study was to compare the clinical effectiveness of expanded polytetrafluoroethylene/fluorinated-ethylene-propylene (ePTFE/FEP)-covered stents with that of uncovered nitinol stents for the palliation of malignant jaundice caused by inoperable pancreatic head cancer. Eighty patients were enrolled in a prospective randomized study. Bare nitinol stents were used in half of the patients, and ePTFE/FEP-covered stents were used in the remaining patients. Patency, survival, complications, and mean cost were calculated in both groups. Mean patency was 166.0 {+-} 13.11 days for the bare-stent group and 234.0 {+-} 20.87 days for the covered-stent group (p = 0.007). Primary patency rates at 3, 6, and 12 months were 77.5, 69.8, and 69.8% for the bare-stent group and 97.5, 92.2, and 87.6% for the covered-stent group, respectively. Mean secondary patency was 123.7 {+-} 22.5 days for the bare-stent group and 130.3 {+-} 21.4 days for the covered-stent group. Tumour ingrowth occurred exclusively in the bare-stent group in 27.5% of cases (p = 0.002). Median survival was 203.2 {+-} 11.8 days for the bare-stent group and 247.0 {+-} 20 days for the covered-stent group (p = 0.06). Complications and mean cost were similar in both groups. Regarding primary patency and ingrowth rate, ePTFE/FEP-covered stents have shown to be significantly superior to bare nitinol stents for the palliation of malignant jaundice caused by inoperable pancreatic head cancer and pose comparable cost and complications. Use of a covered stent does not significantly influence overall survival rate; nevertheless, the covered endoprosthesis seems to offer result in fewer reinterventions and better quality of patient life.

  15. The underdilation of nitinol stents at TIPS implantation: Solution or illusion?

    PubMed

    Mollaiyan, Ashkan; Bettinger, Dominik; Rössle, Martin

    2017-04-01

    This study investigates the behaviour of self-expanding nitinol stents at the time of TIPS-implantation and thereafter. Hundred consecutive patients with cirrhosis receiving a TIPS revision were included. The smallest stent diameter was measured radiologically immediately after implantation and before shunt revision. Accuracy of the measurement was assessed by comparing the nominal stent diameter with the largest stent diameter measured at the time of revision. Pearson correlation between largest measured and nominal diameters was excellent (r=0.952, p<0.001) showing that measurements are accurate. At TIPS implantation all stents were markedly underdilated reaching only 76-92% of their nominal diameter. Smallest measured diameters were similar (8mm) irrespective of the nominal diameter (8, 9, 10mm) of the stent. In addition, smallest diameters of 10mm stents were similar irrespective whether 8, 9 or 10mm balloons were used. During a mean follow-up of 12.7±17.8months (median 3 months, range 1-81) stents expanded by 0.5-1.6mm dependent on the nominal stent size (8, 9, 10mm) and the grade of primary underdilation. No significant difference was found between Viatorr and bare stents. At TIPS-implantation, the compliance of the surrounding tissue predominantly determines the stent diameter. The nominal size of the stent or the dilatation balloon has little influence. Accurate adjustment of a desired pressure gradient is, therefore, not possible. During follow-up, stents expand towards their nominal diameter questioning the usefulness of underdilation. Copyright © 2017 Elsevier B.V. All rights reserved.

  16. Fractures of self-expanding metallic stents in periampullary malignant biliary obstruction.

    PubMed

    Rasmussen, I C; Dahlstrand, U; Sandblom, G; Eriksson, L G; Nyman, R

    2009-09-01

    Self-expanding metallic stents are widely used for relieving biliary duct obstruction in patients with unresectable periampullary malignancies. However, only a few studies have assessed the occurrence of fractures in these stents. To determine the prevalence and significance of stent fracture after placement of self-expanding metallic stents for periampullary malignant biliary obstruction. Over a 5-year period, 48 patients underwent placement of self-expanding metallic stents for periampullary malignant biliary obstructions. Stents were introduced 2-6 weeks after a percutaneous transhepatic biliary decompression. The medical records and relevant images were reviewed for stent patency, stent fracture, type of stent, and stent-related complications. Stent fracture was detected in four of the 48 patients (8%): in one patient at 1 month and in three patients between 10 and 21 months after stenting. All four fractures involved one type of nitinol stent used in 38 patients. In one of the patients, fracture was complicated by life-threatening gastrointestinal bleeding. The mean survival time for all patients was 251 days (standard deviation [SD]+/-275 days) and the mean overall patency time for all stents was 187 days (SD+/-205 days). Stent fracture occurs after placement of self-expanding nitinol stents for periampullary malignant biliary obstruction. The low reported incidence of this complication may be due to a lack of awareness of and difficulty in detecting stent fracture. Fracture should be considered as a possible contributing factor in recurrent biliary obstruction after self-expanding metallic stent insertion.

  17. Recent advances in self-expanding stents for use in the superficial femoral and popliteal arteries.

    PubMed

    Aghel, Arash; Armstrong, Ehrin J

    2014-07-01

    Significant advances have been made in femoropopliteal stent design and clinical outcomes during the past decade. Initial randomized studies demonstrated superiority of nitinol self-expanding stents to balloon angioplasty for treatment of moderate-length superficial femoral artery stenoses. During longer-term follow-up, first generation nitinol stents were hampered by high rates of stent fracture. A number of newer nitinol stent designs have been developed with improved conformability, greater radial strength and lower rates of long-term stent fracture. These newer stent designs have demonstrated superior primary patency and decreased restenosis for the treatment of moderate-length femoropopliteal lesions relative to historical benchmarks. Recent advances in drug-eluting nitinol stents have also offered treatment options for challenging lesion subsets including very long femoropopliteal lesions and for the treatment of in-stent restenosis. This article reviews recent advances and upcoming research in nitinol self-expanding stent technology for the treatment of superficial femoral and popliteal artery stenosis.

  18. Treatment of a malignant esophageal fistula with a Gore-Tex-covered flexible nitinol stent

    SciTech Connect

    Kishi, Kazushi; Takeuchi, Taizo; Sonomura, Tetsuo; Kimura, Masashi; Kita, Keisuke; Sato, Morio; Terada, Masaki

    1997-01-15

    In order to treat fistulated esophageal cancer using a flexible stent, a covered flexible stent was constructed by wrapping a nitinol stent with a thin sheet of Gore-Tex, preserving the stents original advantages of flexibility and a low-profile introducer system. This stent was used to perform standard radiotherapy in a case of fistulated esophageal cancer.

  19. European Experience with the Self-Expanding Nitinol Coil: Pilot Phase Evaluation in Cardiovascular Applications.

    PubMed

    Beyar; Roguin

    1997-03-01

    BACKGROUND: The Cardiocoil (InStent) is a self-expanding nitinol coil that is restrained on a delivery catheter in a compressed state and deployed by a wire based release mechanism. We provide the initial data on the acute results of the use of this stent in a multi-center study in Europe. We also briefly review the other non-coronary applications of this stent. METHODS: One-hundred two stents were implanted in 76 patients for suboptimal results or dissections. There were 39 LAD lesions, 28 RCA lesions and 9 Circumflex lesions. There were eight total occlusions. Lesions were short in 41% (< 10 mm), tubular (between 10 and 20 mm) in 37%, and diffuse (> 20%) in 22%. Stent deployment included predilatation to the reference arterial side and post dilatation after stent deployment. RESULTS: Stent deployment was successful in all cases in which lesions could be crossed. In cases where the stent did not cross the lesion (n=3) it was removed uneventfully. There were no stent losses. Complications included subacute thrombosis in 4/76 (5.3%) patients (1- a long total RCA lesion, 2- diffuse proximal LAD diseases). There were no late acute events after stenting and no stent related mortality. Angiographic quantitative analysis showed that the stent expands by both its intrinsic self-expanding properties and by post deployment balloon assistance. CONCLUSIONS: The self-expanding coil stent for cardiovascular interventions is safe and effective in treating a variety of complex lesions. It provides adequate support to the arterial wall, preventing acute recoil and tacking dissections to the arterial wall. The long-term efficiency of this stent awaits further clinical testing.

  20. Three-year results of the VIBRANT trial of VIABAHN endoprosthesis versus bare nitinol stent implantation for complex superficial femoral artery occlusive disease.

    PubMed

    Geraghty, Patrick J; Mewissen, Mark W; Jaff, Michael R; Ansel, Gary M

    2013-08-01

    The predominant mode of bare nitinol stent failure is diffuse in-stent restenosis, and failure rates correlate to the length and complexity of the treated lesion. Addition of an expanded polytetrafluoroethylene lining to a nitinol stent frame, as found in the VIABAHN endoprosthesis, mitigates the ingrowth of intimal hyperplasia. We compared the long-term outcomes of complex superficial femoral artery disease intervention using the VIABAHN endoprosthesis to those obtained with bare nitinol stent implantation. One hundred forty-eight patients with symptomatic complex superficial femoral artery disease (TransAtlantic Inter-Society Consensus I class C and D lesions, accompanied by intermittent claudication or ischemic rest pain) were randomized to endovascular intervention using either bare nitinol stent implantation (76 patients) or nonheparin-bonded VIABAHN endoprosthesis deployment (72 patients). Patency, limb hemodynamics, and quality of life were evaluated at 1, 6, 12, 24, and 36 months following intervention. The average treated lesion measured 18 ± 8 cm in length, and 58.8% of lesions displayed segmental or complete occlusion. At 3 years, primary patency rates (defined by peak systolic velocity ratio ≤ 2.0 and no target lesion revascularization) did not significantly differ between patients treated with the VIABAHN stent graft and those who received a bare nitinol stent (24.2% vs 25.9%; P = .392). Stent fractures were significantly more common in bare nitinol stents (50.0%) than in the VIABAHN endoprostheses (2.6%). Primary-assisted patency rates were higher in those receiving bare nitinol stents than the VIABAHN stent graft (88.8% vs 69.8%; P = .04), although secondary patency rates did not differ between bare nitinol stent and stent graft recipients (89.3% vs 79.5%; P = .304). There were no instances of procedure-related mortality or amputation. The hemodynamic improvement and quality measures improved equally in both groups. The long-term outcomes of

  1. Contralateral approach to iliac artery recanalization with kissing nitinol stents present in the aortic bifurcation☆

    PubMed Central

    Joseph, George; Hooda, Amit; Thomson, Viji Samuel

    2015-01-01

    A 69-year-old man, who had earlier undergone reconstruction of the aortic bifurcation with kissing nitinol stents, presented with occlusion of the left external iliac artery. The occlusion was successfully and safely recanalized using contralateral femoral approach with passage of interventional hardware through the struts of the stents in the aortic bifurcation. Presence of contemporary flexible nitinol stents with open-cell design in the aortic bifurcation is not a contraindication to the use of the contralateral femoral approach. PMID:26702686

  2. Contralateral approach to iliac artery recanalization with kissing nitinol stents present in the aortic bifurcation.

    PubMed

    Joseph, George; Hooda, Amit; Thomson, Viji Samuel

    2015-01-01

    A 69-year-old man, who had earlier undergone reconstruction of the aortic bifurcation with kissing nitinol stents, presented with occlusion of the left external iliac artery. The occlusion was successfully and safely recanalized using contralateral femoral approach with passage of interventional hardware through the struts of the stents in the aortic bifurcation. Presence of contemporary flexible nitinol stents with open-cell design in the aortic bifurcation is not a contraindication to the use of the contralateral femoral approach.

  3. Treatment of a Ruptured Anastomotic Esophageal Stricture Following Bougienage with a Dacron-Covered Nitinol Stent

    SciTech Connect

    Heindel, Walter; Gossmann, Axel; Fischbach, Roman; Michel, Olaf; Lackner, Klaus

    1996-11-15

    A patient suffering from esophagorespiratory fistula after bougienage of a benign stricture at the site of the anastomosis between a jejunal interposition and the esophagus was referred for interventional treatment. A prototype nitinol stent centrally covered with Dacron was implanted under regional anesthesia and fluoroscopic guidance. The self-expanding prosthesis dilated the stenosis completely and closed the fistula, with consequent improvement in respiratory and nutritional status and thus the general quality of life. The patient was able to eat and drink normally until death 3 months later due to progression of his underlying malignant disease.

  4. Effects of Crimping on Mechanical Performance of Nitinol Stent Designed for Femoral Artery: Finite Element Analysis

    NASA Astrophysics Data System (ADS)

    Nematzadeh, F.; Sadrnezhaad, S. K.

    2013-11-01

    Nitinol stents are used to minimize improper dynamic behavior, low twistability, and inadequate radial mechanical strength of femoral artery stents. In this study, finite element method is used to investigate the effect of crimping and Austenite finish temperature ( A f) of Nitinol on mechanical performance of Z-shaped open-cell femoral stent under crimping conditions. Results show that low A f Nitinol has better mechanical and clinical performance due to small chronic outward force, large radial resistive force, and appropriate superelastic behavior.

  5. Multi-objective optimization of nitinol stent design.

    PubMed

    Alaimo, G; Auricchio, F; Conti, M; Zingales, M

    2017-09-01

    Nitinol stents continuously experience loadings due to pulsatile pressure, thus a given stent design should possess an adequate fatigue strength and, at the same time, it should guarantee a sufficient vessel scaffolding. The present study proposes an optimization framework aiming at increasing the fatigue life reducing the maximum strut strain along the structure through a local modification of the strut profile.The adopted computational framework relies on nonlinear structural finite element analysis combined with a Multi Objective Genetic Algorithm, based on Kriging response surfaces. In particular, such an approach is used to investigate the design optimization of planar stent cell.The results of the strut profile optimization confirm the key role of a tapered strut design to enhance the stent fatigue strength, suggesting that it is possible to achieve a marked improvement of both the fatigue safety factor and the scaffolding capability simultaneously. The present study underlines the value of advanced engineering tools to optimize the design of medical devices. Copyright © 2017 IPEM. Published by Elsevier Ltd. All rights reserved.

  6. 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.

  7. Nitinol stents in the treatment of benign proximal tracheal stenosis or tracheomalacia.

    PubMed

    Isa, A Y; Macandie, C; Irvine, B W

    2006-01-01

    Nitinol stents have been used in the treatment of benign tracheal stenosis. A retrospective review of five patients treated at Stobhill Hospital over the last six and a half years is presented. Age at presentation ranged from 17 to 76 years. The minimum follow-up period was 23 months and the maximum was 78 months. All our patients were successfully decannulated, with none requiring recannulation. Four patients developed granulation tissue related to the stent at intervals ranging from three weeks to 41 months post stenting. Topical mitomycin C application has been useful after resection of granulations using the carbon dioxide (CO2) laser. Stent migration occurred in one patient three weeks after insertion. Nitinol stents are easy to insert and effective in the treatment of tracheal stenosis, but can have associated morbidity. Their use should be considered carefully, as insertion should be regarded as permanent. Publications reporting experience and outcome with the use of Nitinol stents in the trachea are reviewed.

  8. Finite element modeling of a progressively expanding shape memory stent.

    PubMed

    Thériault, Philippe; Terriault, Patrick; Brailovski, Vladimir; Gallo, Richard

    2006-01-01

    Cardiovascular stents are small cylindrical devices introduced in stenosed arteries to reopen the lumen and restore blood flow. However, this treatment presents complications, including restenosis, which is the reclosing of the artery's diameter after the insertion of a stent. The structure of the prosthesis penetrates into and injures the walls of the patient's artery. There then follows a proliferation of cells and the formation of scar tissue around the injury, similar to the scarring of other organic tissues. This reaction to the trauma subjects the artery to close. The proposed solution is to develop a Nitinol stent with a progressive expansion device made of polyethylene, allowing smooth and gradual contact between the stent and the artery's wall by creep effect. The purpose of this paper is to describe the technology and methodology for the numerical study of this kind of stent through the finite element method. ANSYS 8.0 software is used to perform the analysis. The Nitinol is modeled with a superelastic law and the polyethylene with a yield hardening law. A first simulation determines the final geometry of the stent laser cut from a small tube. A second simulation examines the behavior of the prosthesis during surgery and over the 4 weeks following the operation. The results demonstrate that a compromise can be reached between a limited expansion prior the inflation of the expandable balloon and a significant expansion by creep of the polymer rings.

  9. Curve micromachining on the edges of nitinol biliary stent by ultrashort pulses laser

    NASA Astrophysics Data System (ADS)

    Hung, Chia-Hung; Chang, Fuh-Yu

    2017-05-01

    In this study, a curve micromaching process on the edges of nitinol biliary stent was proposed by a femtosecond laser system with a galvano-mirror scanner. Furthermore, the outer diameter of nitinol tube was 5.116 mm, its inner diameter was 4.648 mm, and its length was 100 mm. The initial fabricated results of nitinol biliary stent represented that the edges of nitinol biliary stent were steep and squared by femtosecond laser. However, the results also indicated that if the laser movement path was precisely programmed by utilizing the unique characteristic of Gaussian beam of femtosecond laser with aligning the edges of stent, the radius of edges enhanced significantly from 9 μm to 42.5 μm. As a result, the edges of nitinol biliary stent can be successfully fabricated from squared edges to rounded-shaped edges with precise dimension, clean surface morphology, and minimal heat-affected zone remained. Hence, the nitinol biliary stent, after femtosecond laser micromachining, would not need any further post-process to remove heat-affected zone and the squared edges.

  10. Double-Layered PTFE-Covered Nitinol Stents: Experience in 32 Patients with Malignant Esophageal Strictures

    SciTech Connect

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

    2010-08-15

    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.

  11. Nitinol Stent Oversizing in Patients Undergoing Popliteal Artery Revascularization: A Finite Element Study.

    PubMed

    Gökgöl, Can; Diehm, Nicolas; Nezami, Farhad Rikhtegar; Büchler, Philippe

    2015-12-01

    Nitinol stent oversizing is frequently performed in peripheral arteries to ensure a desirable lumen gain. However, the clinical effect of mis-sizing remains controversial. The goal of this study was to provide a better understanding of the structural and hemodynamic effects of Nitinol stent oversizing. Five patient-specific numerical models of non-calcified popliteal arteries were developed to simulate the deployment of Nitinol stents with oversizing ratios ranging from 1.1 to 1.8. In addition to arterial biomechanics, computational fluid dynamics methods were adopted to simulate the physiological blood flow inside the stented arteries. Results showed that stent oversizing led to a limited increase in the acute lumen gain, albeit at the cost of a significant increase in arterial wall stresses. Furthermore, localized areas affected by low Wall Shear Stress increased with higher oversizing ratios. Stents were also negatively impacted by the procedure as their fatigue safety factors gradually decreased with oversizing. These adverse effects to both the artery walls and stents may create circumstances for restenosis. Although the ideal oversizing ratio is stent-specific, this study showed that Nitinol stent oversizing has a very small impact on the immediate lumen gain, which contradicts the clinical motivations of the procedure.

  12. Endovascular Treatment of a Giant Superior Mesenteric Artery Pseudoaneurysm Using a Nitinol Stent-Graft

    SciTech Connect

    Gandini, Roberto; Pipitone, Vincenzo; Konda, Daniel Pendenza, Gianluca; Spinelli, Alessio; Stefanini, Matteo; Simonetti, Giovanni

    2005-01-15

    A 68-year-old woman presenting with gastrointestinal bleeding (hematocrit 19.3%) and in a critical clinical condition (American Society of Anesthesiologists grade 4) from a giant superior mesenteric artery pseudoaneurysm (196.0 x 131.4 mm) underwent emergency endovascular treatment. The arterial tear supplying the pseudoaneurysm was excluded using a 5.0 mm diameter and 31 mm long monorail expanded polytetrafluoroethylene (ePTFE)-covered self-expanding nitinol stent. Within 6 days of the procedure, a gradual increase in hemoglobin levels and a prompt improvement in the clinical condition were observed. Multislice CT angiograms performed immediately, 5 days, 30 days and 3 months after the procedure confirmed the complete exclusion of the pseudoaneurysm.

  13. Intravascular Ultrasound-Derived Stent Dimensions as Predictors of Angiographic Restenosis Following Nitinol Stent Implantation in the Superficial Femoral Artery.

    PubMed

    Miki, Kojiro; Fujii, Kenichi; Kawasaki, Daizo; Shibuya, Masahiko; Fukunaga, Masashi; Imanaka, Takahiro; Tamaru, Hiroto; Sumiyoshi, Akinori; Nishimura, Machiko; Horimatsu, Tetsuo; Saita, Ten; Okada, Kozo; Kimura, Takumi; Honda, Yasuhiro; Fitzgerald, Peter J; Masuyama, Tohru; Ishihara, Masaharu

    2016-06-01

    To identify intravascular ultrasound (IVUS) measurements that can predict angiographic in-stent restenosis (ISR) following nitinol stent implantation in superficial femoral artery (SFA) lesions. A retrospective review was conducted of 97 patients (mean age 72.9±8.9 years; 63 men) who underwent IVUS examination during endovascular treatment of 112 de novo SFA lesions between July 2012 and December 2014. Self-expanding bare stents were implanted in 46 lesions and paclitaxel-eluting stents in 39 lesions. Six months after stenting, follow-up angiography was conducted to assess stent patency. The primary endpoint was angiographic ISR determined by quantitative vascular angiography analysis at the 6-month follow-up. Variables associated with restenosis were sought in multivariate analysis; the results are presented as the odds ratio (OR) and 95% confidence interval (CI). At follow-up, 27 (31.8%) angiographic ISR lesions were recorded. The lesions treated with uncoated stents were more prevalent in the ISR group compared with the no restenosis group (74.1% vs 44.8%, p=0.02). Lesion length was longer (154.4±79.5 vs 109.0±89.3 mm, p=0.03) and postprocedure minimum stent area (MSA) measured by IVUS was smaller (13.9±2.8 vs 16.3±1.6 mm(2), p<0.001) in the ISR group. Multivariate analysis revealed that bare stent use (OR 7.11, 95% CI 1.70 to 29.80, p<0.01) and longer lesion length (OR 1.08, 95% CI 1.01 to 1.16, p=0.04) were predictors of ISR, while increasing postprocedure MSA (OR 0.58, 95% CI 0.41 to 0.82, p<0.01) was associated with lower risk of ISR. Receiver operating characteristic analysis identified a MSA of 15.5 mm(2) as the optimal cutpoint below which the incidence of restenosis increased (area under the curve 0.769). Postprocedure MSA can predict ISR in SFA lesions, which suggests that adequate stent enlargement during angioplasty might be required for superior patency. © The Author(s) 2016.

  14. Endoscopic Removal of a Nitinol Mesh Stent from the Ureteropelvic Junction after 15 Years

    PubMed Central

    Smrkolj, Tomaž; Šalinović, Domagoj

    2015-01-01

    We report a rare case of a patient with a large stone encrusted on a nitinol mesh stent in the ureteropelvic junction. The stent was inserted in the year 2000 after failure of two pyeloplasty procedures performed due to symptomatic ureteropelvic junction stenosis. By combining minimally invasive urinary stone therapies—extracorporeal shock wave lithotripsy, semirigid ureterorenoscopy with laser lithotripsy, and percutaneous nephrolithotomy—it was possible to completely remove the encrusted stone and nitinol mesh stent that was implanted for 15 years, rendering the patient symptom and obstruction free. PMID:26697258

  15. A direct nitinol stent delivery technique for endovascular treatment: a sheath-less stenting technique.

    PubMed

    Shintani, Yoshiaki; Kawasaki, Tomohiro; Fujimura, Takashi; Ishida, Kouichirou; Higuchi, Takanori; Kajiwara, Masataka; Fukuoka, Ryota; Orita, Yoshiya; Umeji, Kyoko; Koga, Hisashi; Koga, Nobuhiko

    2015-04-01

    Access site problems often cause serious complications in endovascular treatment. The aim of this study is to investigate whether a sheath-less nitinol stenting technique leads to reduce access site complications. This study was a single-center retrospective analysis of a prospectively maintained database. The study enrolled consecutive 98 patients with 111 lesions undergoing provisional stenting for de novo iliac artery or femoro-popliteal artery stenosis between August 2010 and November 2011. The patients were divided into two groups, a conventional procedure group and a sheath-less procedure group. The outcomes of this study were peri-procedural access site complications, initial success rate, procedure time, hemostatic time and bed-rest time. Forty-four lesions in 39 patients that treated using the sheath-less nitinol stent delivery technique were compared with 67 lesions in 59 patients treated using the conventional procedure. All procedures were successful. The incidence of pseudoaneurysm was significantly lower in the sheath-less procedure group than in the conventional procedure group (p = 0.043). However, there were no significant differences in any other complications. No significant difference was observed in the procedural time (p = 0.309). However, hemostatic time and bed-rest time were significantly shorter in the sheath-less procedure than in the conventional procedure (p < 0.0001). A sheath-less stenting technique reduced the access site incidence of pseudoaneurysm and did not increase other access site complications. Besides, this technique shortened hemostatic time and bed-rest time. The sheath-less stenting technique is considered to be a useful method for endovascular treatment.

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

    PubMed Central

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

    2016-01-01

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

  17. Statistical characteristics of surface integrity by fiber laser cutting of Nitinol vascular stents

    NASA Astrophysics Data System (ADS)

    Fu, C. H.; Liu, J. F.; Guo, Andrew

    2015-10-01

    Nitinol alloys have been widely used in manufacturing of vascular stents due to the outstanding properties such as superelasticity, shape memory, and superior biocompatibility. Laser cutting is the dominant process for manufacturing Nitinol stents. Conventional laser cutting usually produces unsatisfactory surface integrity which has a significant detrimental impact on stent performance. Emerging as a competitive process, fiber laser with high beam quality is expected to produce much less thermal damage such as striation, dross, heat affected zone (HAZ), and recast layer. To understand the process capability of fiber laser cutting of Nitinol alloy, a design-of-experiment based laser cutting experiment was performed. The kerf geometry, roughness, topography, microstructure, and hardness were studied to better understand the nature of the HAZ and recast layer in fiber laser cutting. Moreover, effect size analysis was conducted to investigate the relationship between surface integrity and process parameters.

  18. Polyurethane-Covered Nitinol Strecker Stents as Primary Palliative Treatment of Malignant Biliary Obstruction

    SciTech Connect

    Kanasaki, Shuzo; Furukawa, Akira; Kane, Teruyuki; Murata, Kiyoshi

    2000-03-15

    Purpose: To evaluate the clinical efficacy of the polyurethane-covered Nitinol Strecker stent in the treatment of patients with malignant biliary obstruction.Methods: Twenty-three covered stents produced by us were placed in 18 patients with malignant biliary obstruction. Jaundice was caused by cholangiocarcinoma (n = 5), pancreatic cancer (n = 6), gallbladder cancer (n = 4), metastatic lymph nodes (n = 2), and tumor of the papilla (n 1).Results: The mean patency period of the stents was 37.5 weeks (5-106 weeks). Recurrent obstructive jaundice occurred in two patients (11%). Adequate biliary drainage over 50 weeks or until death was achieved in 17 of 18 patients (94.4%). Late cholangitis was observed in two patients whose stents bridged the ampulla of Vater. Other late severe complications were not encountered.Conclusion: Although more study is necessary, our results suggest the clinical efficacy of our covered Nitinol Strecker stent in the management of obstructive jaundice caused by malignant diseases.

  19. Tricuspid valved stent implantation: novel stent with a self-expandable super-absorbent polymer.

    PubMed

    Iino, Kenji; Lozonschi, Lucian; Metzner, Anja; Marczynski-Bühlow, Martin; Renner, Jochen; Cremer, Jochen; Lutter, Georg

    2011-08-01

    Trans-catheter aortic and pulmonary valve replacement procedures can result in favorable outcomes in selected patients. The aim of this study was to investigate the functioning of a novel self-expanding valved stent with super-absorbent polymer (SAP) for minimally invasive replacement of the tricuspid valve. A newly designed nitinol stent with SAP was specially designed for the tricuspid annulus. This device was composed of right atrial anchoring elements, a left ventricular tubular stent, and a trileaflet bovine pericardial valve. The stent was coated with a waterproof material, and a pouch containing SAP for minimizing paravalvular leakage was placed beneath the atrial element. Seven pigs underwent minimally invasive off-pump tricuspid valved stent implantation. This was performed through a lower ministernotomy using a transventricular approach under transesophageal echocardiographic guidance. After 1 and 6h, a complete echocardiographic evaluation and hemodynamics (Swan-Ganz catheter) were performed. Six of seven pigs exhibited normal hemodynamics immediately after tricuspid valved stent implantation and maintained stability for the entire period of monitoring. In one pig, a part of the atrial stent elements was deployed into the right ventricle, leading to significant paravalvular leakage, and died very soon. All subsequent animals survived with good results in the observation period. Accurate positioning of the valved stent was documented in six of seven pigs. SAP expanded and filled the gap between the stent and the native annulus in all animals. Mild paravalvular leakage was found in two of the six animals. Nevertheless, the observed leakage decreased to trace levels 6h after implantation. In the additional four pigs, only trace tricuspid regurgitation was revealed. No right ventricular outflow tract obstruction was detected. Trans-apical off-pump tricuspid valved stent implantation is feasible in an acute experimental setting, and SAP may help to reduce

  20. Carotid Artery Stenting Using a Novel Self-Expanding Braided Nickel-Titanium Stent: Feasibility and Safety Porcine Trial

    SciTech Connect

    Ahlhelm, Frank Kaufmann, Ralf; Ahlhelm, Dirk Ong, Mai Fang; Roth, Christian Reith, Wolfgang

    2009-09-15

    We studied the deliverability and safety of a braided, self-expanding, closed-cell nickel-titanium (NiTi) stent (E-volution, Jotec GmbH, Hechingen, Germany) especially designed for the endovascular treatment of carotid artery bifurcation stenosis with special regard to in-stent stenosis and thrombosis compared with a laser-cut reference nitinol stent in a porcine model of percutaneous vascular interventions. We aimed to assess histopathologic response in minipig carotid and subclavian arteries. Eight minipigs received a total of 42 stents: 14 reference stents and 28 E-volution stents. Eleven of the E-volution stents were additionally coated with heparin. Control angiography was obtained immediately before and after vascular intervention as well as 4 weeks after the procedure. Primary endpoints were 28 days of angiographic analyses as well as histomorphometric analysis, including injury score, inflammation score, luminal diameter, vessel diameter, maximal neointimal thickness, and area of in-stent stenosis. Secondary end points were procedural success, 28-day mortality, and stent thrombosis. All stents could be delivered successfully without procedural complications, morbidity, or mortality during our observation time. As confirmed by histology, no in-stent thrombosis was observed. Compared with common carotid arteries, subclavian arteries are significantly more vulnerable to developing in-stent stenosis caused by neointima proliferation (p < 0.05). Compared with the use of 1 single stent/artery, serial application of two stents leads to a more excessive but not significantly different neointimal proliferation (p > 0.05). The E-volution stent, especially when heparin coated, is in line with the comparison to the laser-cut reference stent displaying similar results of angiographic, histologic, and histomorphometric analyses (p > 0.05). Compared with the reference laser-cut stent, the self-expanding nitinol stent (E-volution) with its advanced braiding technology is

  1. 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.

  2. Self-expanding intracoronary stents in the treatment of coronary artery disease: new developments and future directions.

    PubMed

    Lu, H; Grundeken, M J; Koch, K T; Wykrzykowska, J J

    2013-10-01

    The first stent implanted in the human coronary circulation was a self-expandable (SE) stent and was introduced almost simultaneously with the first balloon-expandable (BE) stents in the late 1980s. Nowadays, the majority of the available stents are delivered by balloon expansion. While BE stents reach their final size at the time of implantation, the SE stent continues to enlarge days to weeks after implantation. Potential advantages of the self-expandable and self-apposing properties of nitinol stents, a super-elastic metallic alloy of nickel and titanium, could be reduction of acute and late acquired stent malapposition with a subsequently decreased risk of target vessel restenosis. Several nitinol stents have been developed and clinically evaluated and are now in use in daily clinical practice. However, it is important to further improve and optimize the SE stent design and apply newer strategies to the development of next generation SE stents. The present review will provide an overview of the development of these devices and the currently available clinical evidence of the contemporary SE stents.

  3. Evaluation of Nitinol Stents Using a 3-Dimensional Printed Superficial Femoral Artery Model: A Preliminary Study.

    PubMed

    Girsowicz, Elie; Georg, Yannick; Seiller, Hélène; Lejay, Anne; Thaveau, Fabien; Heim, Frédéric; Chakfe, Nabil

    2016-05-01

    Mechanical tests assessing Nitinol stents used for the superficial femoral artery (SFA) are designed without taking into account their deployment environments. The objectives of this study were (1) to create normal and pathologic femoral artery models, (2) to run mechanical tests reproducing the stresses of the SFA, and (3) to study and compare Nitinol stents in those conditions. Femoral artery models with identical mechanical properties to the SFA were created using the 3-dimensional printing technology. Those models were designed with and without an asymmetric focal 50% stenosis. Three mechanical tests (bending-compression, bending-compression-torsion, and multiple bending tests) were created and 1 flexible stent was tested, of 6 and 7-mm diameter. Three samples of the stent, LifeStent (Bard(®)), were deployed and tested in the models. Stents alone were evaluated in the same conditions. The analysis focused on the comparison of rheologic curves, level of kink, and the energy deployed for each stent to kink. In the 3 tests, all stents deployed in the models presented a kink during their evaluation. When tested alone, during the compression-bending and bending-compression-torsion tests, no plicature was observed. During the multiple bending test, the energy deployed to plicature for the stent tested alone was of 1.4 ± 0.10 and 2.84 ± 0.1 J compared with 9.7 ± 0.6 and 8.25 ± 0.6 J when deployed in the model for the Lifestent 6 × 80 and 7 × 80 mm, respectively. For all of these 3 tests, 6-mm diameter stents exhibited a level of kink and energy of kink higher than 7 mm stents. The behavior of the stents changed in the stenosed model whatever diameter is taken into account. Analysis of the rheologic curves showed a decrease in the inflection of the curve related to the plication. In the bending-compression test, the presence of a stenosis lead to an early plication of the model, with less deployed kinking energy whereas in the bending

  4. High-resolution 3D X-ray imaging of intracranial nitinol stents.

    PubMed

    Snoeren, Rudolph M; Söderman, Michael; Kroon, Johannes N; Roijers, Ruben B; de With, Peter H N; Babic, Drazenko

    2012-02-01

    To assess an optimized 3D imaging protocol for intracranial nitinol stents in 3D C-arm flat detector imaging. For this purpose, an image quality simulation and an in vitro study was carried out. Nitinol stents of various brands were placed inside an anthropomorphic head phantom, using iodine contrast. Experiments with objects were preceded by image quality and dose simulations. We varied X-ray imaging parameters in a commercially interventional X-ray system to set 3D image quality in the contrast-noise-sharpness space. Beam quality was varied to evaluate contrast of the stents while keeping absorbed dose below recommended values. Two detector formats were used, paired with an appropriate pixel size and X-ray focus size. Zoomed reconstructions were carried out and snapshot images acquired. High contrast spatial resolution was assessed with a CT phantom. We found an optimal protocol for imaging intracranial nitinol stents. Contrast resolution was optimized for nickel-titanium-containing stents. A high spatial resolution larger than 2.1 lp/mm allows struts to be visualized. We obtained images of stents of various brands and a representative set of images is shown. Independent of the make, struts can be imaged with virtually continuous strokes. Measured absorbed doses are shown to be lower than 50 mGy Computed Tomography Dose Index (CTDI). By balancing the modulation transfer of the imaging components and tuning the high-contrast imaging capabilities, we have shown that thin nitinol stent wires can be reconstructed with high contrast-to-noise ratio and good detail, while keeping radiation doses within recommended values. Experimental results compare well with imaging simulations.

  5. Effects of Oxide Layer Composition and Radial Compression on Nickel Release in Nitinol Stents

    NASA Astrophysics Data System (ADS)

    Sullivan, Stacey J. L.; Dreher, Maureen L.; Zheng, Jiwen; Chen, Lynn; Madamba, Daniel; Miyashiro, Katie; Trépanier, Christine; Nagaraja, Srinidhi

    2015-09-01

    There is a public health need to understand the effects of surface layer thickness and composition on corrosion in nickel-containing medical devices. To address this knowledge gap, five groups of Nitinol stents were manufactured by various processing methods that altered the titanium oxide layer. The following surfaces were created: >3500 nm thick mixed thermal oxide (OT), ~420 nm thick mixed thermal oxide (SP), ~130 nm thick mixed thermal oxide (AF), ~4 nm thick native oxide (MP), and an ~4 nm thick passivated oxide (EP). Radially compressed and not compressed devices were evaluated for nickel (Ni) ion release in a 60-day immersion test. The results indicated that OT stents released the most Ni, followed by stents in the SP and AF groups. For OT and SP stents, which exhibited the thickest oxide layers, radial compression significantly increased Ni release when compared to non-compressed stents. This result was not observed in AF, MP, SP stents indicating that the increased Ni release may be explained by cracking of the thicker oxide layers during crimping. Strong correlations were observed between oxide layer thickness and cumulative Ni release. These findings elucidate the importance of oxide layer thickness and composition on uniform corrosion of laser-cut Nitinol stents.

  6. A Novel Thin Film Nitinol Covered Neurovascular Stent Significantly Decreases Intra-Aneurysmal Flow In Vitro

    NASA Astrophysics Data System (ADS)

    Chun, Youngjae; Hur, Soojung; Shayan, Mahdis; Kealey, Colin; Levi, Daniel; Mohanchandra, Kp; di Carlo, Dino; Carman, Gregory

    2013-11-01

    A novel thin film nitinol (TFN) stent has been developed to promote aneurysm quiescence by diminishing flow across the aneurysm's neck. Laboratory aneurysm models were used to assess the flow changes produced by stents covered with different patterns of TFN. Flow diversion stents were constructed by covering Wingspan stents (Boston Scientific, DxL:4x20mm) with TFNs (i.e., 77 and 82 percent porosity). The flow changes that occur after deployment of two different porous TFN covered stent in intracranial aneurysm models were evaluated in vitro. The 82 percent porous TFN covered stent reduced the intra-aneurysmal mean flow velocity by 86.42 percent, while a 77 percent porous TFN covered stent reduced to intra-aneurysmal mean flow velocity to 93.44 percent compared to a nonstented model. Local wall shear rates were also significantly reduced in wide-neck aneurysm model (i.e., 97.52 - 98.92 percent) with TFN stent placement. The results showed that TFN covered stents significantly reduced intra-aneurysmal flow velocity magnitudes and local wall shear rates. This suggests that TFN covered stents with both 77 and 82 percent porosity have great potential to promote thrombosis in both wide-necked and fusiform aneurysm sacs.

  7. Oversizing and Restenosis with Self-Expanding Stents in Iliofemoral Arteries

    SciTech Connect

    Saguner, Ardan M. Traupe, Tobias; Raeber, Lorenz; Hess, Nina; Banz, Yara; Saguner, Arhan R.; Diehm, Nicolas; Hess, Otto M.

    2012-08-15

    Purpose: Uncoated self-expanding nitinol stents (NS) are commonly oversized in peripheral arteries. In current practice, 1-mm oversizing is recommended. Yet, oversizing of NS may be associated with increased restenosis. To provide further evidence, NS were implanted in porcine iliofemoral arteries with a stent-to-artery-ratio between 1.0 and 2.3. Besides conventional uncoated NS, a novel self-expanding NS with an antiproliferative titanium-nitride-oxide (TiNOX) coating was tested for safety and efficacy. Methods: Ten uncoated NS and six TiNOX-coated NS (5-6 mm) were implanted randomly in the iliofemoral artery of six mini-pigs. After implantation, quantitative angiography (QA) was performed for calculation of artery and minimal luminal diameter. Follow-up was performed by QA and histomorphometry after 5 months. Results: Stent migration, stent fracture, or thrombus formation were not observed. All stents were patent at follow-up. Based on the location of the stent (iliac/femoral) and the stent-to-artery-ratio, stent segments were divided into 'normal-sized' (stent-to-artery-ratio < 1.4, n = 12) and 'oversized' (stent-to-artery-ratio {>=} 1.4, n = 9). All stent segments expanded to their near nominal diameter during follow-up. Normal-sized stent segments increased their diameter by 6% and oversized segments by 29%. A significant correlation between oversizing and restenosis by both angiography and histomorphometry was observed. Restenosis rates were similar for uncoated NS and TiNOX-coated NS. Conclusions: TiNOX-coated NS are as safe and effective as uncoated NS in the porcine iliofemoral artery. All stents further expand to near their nominal diameter during follow-up. Oversizing is linearly and positively correlated with neointimal proliferation and restenosis, which may not be reduced by TiNOX-coating.

  8. Nitinol Fatigue Investigation on Stent-Finish Specimens Using Tension-Tension Method

    NASA Astrophysics Data System (ADS)

    Lin, Z.; Pike, K.; Zipse, A.; Schlun, M.

    2011-07-01

    Nitinol fatigue strain limit versus both strain amplitude (range 0.25-1.25%) and mean strain (1.0, 2.0, and 4.0%) was investigated using a tension-tension method. In order to apply the fatigue testing results to a nitinol stent and evaluate stent fatigue performance, the dog-bone style specimens were processed from the same raw material common to implantable stent manufacturing, i.e., similar nitinol tubing, surface quality, and electropolished surface. To simulate a physiological environment, the tension-tension fatigue tests were conducted in water at 37 °C. This strain-controlled fatigue test was conducted with a run-out set at 106 cycles. The fatigue strain limit at 106 cycles as well as the mean strain effect and the effects of inclusions are discussed. Fatigue results appeared in a bi-modal pattern when the strain amplitude was at a level between too high, which made all specimens to fail, and too low, which allowed all specimens to survive.

  9. Polyorethaoe-covered nitinol strecker stents as primary palliative treatment of malignant biliary obstruction

    SciTech Connect

    Kanasaki, Shuzo; Furukawa, Akira; Kane, Teruyuki; Murata, Kiyoshi

    2000-03-15

    Purpose: To evaluate the clinical efficacy of the polyure-thane-covered Nitinol Strecker stent in the treatment of patients with malignant biliary obstruction.Methods: Twenty-three covered stents produced by us were placed in 18 patients with malignant biliary obstruction. Jaundice was caused by cholangiocarcinoma (n=5), pancreatic Cancer (n=6), gallbladder Cancer (n=4), metastatic lymph nodes (n=2), and tumor of the papilla (n=1).Resulrs: The mean patency period of the Stents was 37.5 weeks (5-106 weeks). Recurrent obstructive jaundice occurred in two patients (11%). Adequate biliary drainage over 50 weeks or until death was achieved in 17 of 18 patients (94.4%). Late cholangitis was observed in two patients whose stents bridged the ampulla of Vater. Other late severe complications were not encountered.Conclusion: Although more study is necessary, our results suggest the clinical efficacy of our covered Nitinol Strecker stent in the management of obstructive jaundice caused by malignant diseases.

  10. Nitinol stents loaded with a high dose of antitumor 5-fluorouracil or paclitaxel: esophageal tissue responses in a porcine model.

    PubMed

    Wang, Zhongmin; Liu, Jieying; Wu, Keqin; Shen, Yuanyuan; Mao, Aiwu; Li, Jian; Chen, Zhijin; Guo, Shengrong

    2015-07-01

    A poor prognosis associated with esophageal cancer leads to surgical resection not suitable for most patients. Nitinol stents loaded with 50% 5-fluorouracil (5-FU) or paclitaxel (PTX), functioning both as a stent and local chemotherapy, could provide a new therapy modality for these patients. To investigate esophageal tissue responses to nitinol stents loaded with 50% 5-FU or PTX implanted in the esophagus of healthy pigs. Twenty-three healthy Bama mini-pigs were randomly divided into 4 groups for stent implantation: group A (PTX stent, n = 13), group B (5-FU stent, n = 8), group C (blank film-covered stent, n = 1), and group D (bare stent, n = 1). Tissue responses were observed by endoscopy or pathologic analyses, and 5-FU or PTX concentrations were measured in the esophagus at the stent implantation site at different time points. Animal laboratory. Endoscopic placement of esophagus stent. Endoscopic examination, histology, and drug concentration analysis. In general, the esophageal tissue responses varied according to different parts of 5-FU or PTX stent (middle part [drug-containing part] and bare ends [drug-free part]). Severe tissue responses at the bare ends of the stent included inflammation, ulceration, and granulation. However, the tissue responses were greatly reduced in the middle part of the stent. The drug concentrations in the esophagus that had contact with the 5-FU stent or PTX stent were very high, especially for the first period after implantation, which did not cause obvious tissue damage. Some subjects had incomplete follow-up because of unexpected deaths and stent migration. The nitinol stents loaded with 50% 5-FU or PTX did not cause severe esophageal tissue responses, although there was a large concentration of the drug in these tissues. Copyright © 2015 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

  11. Wire-Interwoven Nitinol Stent Outcome in the Superficial Femoral and Proximal Popliteal Arteries: Twelve-Month Results of the SUPERB Trial.

    PubMed

    Garcia, Lawrence; Jaff, Michael R; Metzger, Christopher; Sedillo, Gino; Pershad, Ashish; Zidar, Frank; Patlola, Raghotham; Wilkins, Robert G; Espinoza, Andrey; Iskander, Ayman; Khammar, George S; Khatib, Yazan; Beasley, Robert; Makam, Satyaprakash; Kovach, Richard; Kamat, Suraj; Leon, Luis R; Eaves, William Britton; Popma, Jeffrey J; Mauri, Laura; Donohoe, Dennis; Base, Carol C; Rosenfield, Kenneth

    2015-05-01

    Stent-based therapy in the superficial femoral and popliteal arteries in patients with peripheral artery disease is compromised by restenosis and risk of stent fracture or distortion. A novel self-expanding nitinol stent was developed that incorporates an interwoven-wire design (Supera stent, IDEV Technologies, Inc, Webster, TX) to confer greater radial strength, flexibility, and fracture resistance. This prospective, multicenter, investigational device exemption, single-arm trial enrolled 264 patients with symptomatic peripheral artery disease undergoing percutaneous treatment of de novo or restenotic lesions of the superficial femoral or proximal popliteal (femoropopliteal) artery. Freedom from death, target lesion revascularization, or any amputation of the index limb at 30 days (+ 7 days) postprocedure was achieved in 99.2% (258/260) of patients (P < 0.001). Primary patency at 12 months (360 ± 30 days) was achieved in 78.9% (180/228) of the population (P < 0.001). Primary patency by Kaplan-Meier analysis at 12 months (360 days) was 86.3%. No stent fracture was observed by independent core laboratory analysis in the 243 stents (228 patients) evaluated at 12 months. Clinical assessment at 12 months demonstrated improvement by at least 1 Rutherford-Becker category in 88.7% of patients. The SUPERB Trial, an investigational device exemption study using an interwoven nitinol wire stent in the femoropopliteal artery, achieved the efficacy and safety performance goals predesignated by the Food and Drug Administration. On the basis of the high primary patency rate, absence of stent fracture, and significant improvements in functional and quality-of-life measures, the Supera stent provides safe and effective treatment of femoropopliteal lesions in symptomatic patients with peripheral artery disease. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00933270. © 2015 American Heart Association, Inc.

  12. Effect of laser polishing on the surface roughness and corrosion resistance of Nitinol stents.

    PubMed

    Park, Chan-Hee; Tijing, Leonard D; Pant, Hem Raj; Kim, Cheol Sang

    2015-01-01

    In this paper, we investigated the effect of laser polishing at different treatment times on the surface roughness and corrosion resistance of a biliary nickel-titanium (NiTi or Nitinol) stent. A specific area of the stent wire surface was checked for changes in roughness by scanning electron microscopy (SEM) and a noncontact profilometer. The corrosion resistance was assessed by potentiodynamic polarization test and electrochemical impedance spectroscopy. The surface characterization revealed that laser polishing reduced the surface roughness of stent by 34-64% compared to that of the as-received stent surface condition depending on the treatment time (i.e., 700-1600 μm). Measurements using potentiodynamic polarization in simulated body fluid solution showed better anti-corrosion performance of laser-polished stent compared to magnetically-polished stent and has comparable corrosion resistance with the as-received stent condition. In this paper, we have shown a preliminary study on the potential of laser polishing for the improvement of surface roughness of stent without affecting much its corrosion resistance.

  13. Covered nitinol stents for the treatment of esophageal strictures and leaks

    PubMed Central

    Bona, Davide; Laface, Letizia; Bonavina, Luigi; Abate, Emmanuele; Schaffer, Moshe; Ugenti, Ippazio; Siboni, Stefano; Carrinola, Rosaria

    2010-01-01

    AIM: To compare 2 different types of covered esophageal nitinol stents (Ultraflex and Choostent) in terms of efficacy, complications, and long-term outcome. METHODS: A retrospective review of a consecutive series of 65 patients who underwent endoscopic placement of an Ultraflex stent (n = 33) or a Choostent (n = 32) from June 2001 to October 2009 was conducted. RESULTS: Stent placement was successful in all patients without hospital mortality. No significant differences in patient discomfort and complications were observed between the Ultraflex stent and Choostent groups. The median follow-up time was 6 mo (inter-quartile range 3-16 mo). Endoscopic reintervention was required in 9 patients (14%) because of stent migration or food obstruction. No significant difference in the rate of reintervention between the 2 groups was observed (P = 0.8). The mean dysphagia score 1 mo after stent placement was 1.9 ± 0.3 for the Ultraflex stent and 2.1 ± 0.4 for the Choostent (P = 0.6). At 1-mo follow-up endoscopy, the cover membrane of the stent appeared to be damaged more frequently in the Choostent group (P = 0.34). Removal of the Choostent was possible up to 8 wk without difficulty. CONCLUSION: Ultraflex and Choostent proved to be equally reliable for palliation of dysphagia and leaks. Removal of the Choostent was easy and safe under mild sedation. PMID:20458763

  14. Covered nitinol stents for the treatment of esophageal strictures and leaks.

    PubMed

    Bona, Davide; Laface, Letizia; Bonavina, Luigi; Abate, Emmanuele; Schaffer, Moshe; Ugenti, Ippazio; Siboni, Stefano; Carrinola, Rosaria

    2010-05-14

    To compare 2 different types of covered esophageal nitinol stents (Ultraflex and Choostent) in terms of efficacy, complications, and long-term outcome. A retrospective review of a consecutive series of 65 patients who underwent endoscopic placement of an Ultraflex stent (n = 33) or a Choostent (n = 32) from June 2001 to October 2009 was conducted. Stent placement was successful in all patients without hospital mortality. No significant differences in patient discomfort and complications were observed between the Ultraflex stent and Choostent groups. The median follow-up time was 6 mo (inter-quartile range 3-16 mo). Endoscopic reintervention was required in 9 patients (14%) because of stent migration or food obstruction. No significant difference in the rate of reintervention between the 2 groups was observed (P = 0.8). The mean dysphagia score 1 mo after stent placement was 1.9 +/- 0.3 for the Ultraflex stent and 2.1 +/- 0.4 for the Choostent (P = 0.6). At 1-mo follow-up endoscopy, the cover membrane of the stent appeared to be damaged more frequently in the Choostent group (P = 0.34). Removal of the Choostent was possible up to 8 wk without difficulty. Ultraflex and Choostent proved to be equally reliable for palliation of dysphagia and leaks. Removal of the Choostent was easy and safe under mild sedation.

  15. 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.

  16. Primary nitinol stenting in femoropopliteal occlusive disease: a meta-analysis of randomized controlled trials.

    PubMed

    Acin, Francisco; de Haro, Joaquin; Bleda, Silvia; Varela, Cesar; Esparza, Leticia

    2012-10-01

    To determine the efficacy and safety of balloon angioplasty (BA) with optional stenting vs. routine stenting with current open cell nitinol stents for femoropopliteal occlusive disease by analyzing the overall results from all available randomized controlled trials. A bibliographic search of electronic medical databases (MEDLINE, Embase, ISI Web of Knowledge, and the Cochrane Central Register of Controlled Trials) was conducted to identify relevant articles from 1960 to July 2011. Of the 701 published articles retrieved, 17 clinical trials randomized patients with symptomatic femoropopliteal occlusive disease to either primary BA or primary stenting. Of these, 4 RCTs involved the use of currently employed high flexibility nitinol stents. Thirteen other trials that employed obsolete, steel, or coated stents were excluded. The technical success rate, the target lesion revascularization (TLR) rate, and the binary restenosis rate at 12 months were primary efficacy endpoints; mortality was the primary safety endpoint. The results are reported as the odds ratio (OR) with 2-tailed 95% confidence intervals (95% CI). The study population was made up of 627 patients (416 men; mean age 67±10 years) and 665 lesions (361 assigned to the primary stenting and 304 to BA). The mean length of the treated lesion was similar in both groups (74.6±45.7 mm in the stenting group vs. 66.7±41.3 mm in the BA group). Technical success was significantly higher in the stenting group compared to BA (95.8% vs. 64.2%; OR 0.31, 95% CI 0.09 to 0.92, p<0.001). Follow-up ranged from 12 to 24 months. Based on 3 studies, the TLR at 12 months favored the stent group (OR 2.47, 95% CI 0.72 to 8.49, p=0.065), but the difference did not reach statistical significance. However, the 12-month binary restenosis rate was significantly lower in the primary stenting group (OR 3.02, 95% CI 1.3 to 6.71, p<0.001). With respect to the safety endpoint, mortality was similar in both groups (OR 0.83, 95% CI 0.39 to 1

  17. The effects of surface processing on in-vivo corrosion of Nitinol stents in a porcine model.

    PubMed

    Sullivan, Stacey J L; Madamba, Daniel; Sivan, Shiril; Miyashiro, Katie; Dreher, Maureen L; Trépanier, Christine; Nagaraja, Srinidhi

    2017-10-15

    A major limitation with current assessments of corrosion in metallic medical devices is the lack of correlation between in-vitro and in-vivo corrosion performance. Therefore, the objective of this study was to elucidate the relationship between pitting corrosion measured by breakdown potentials (Eb) in ASTM F2129 testing and corrosion resistance in-vivo. Four groups of Nitinol stents were manufactured using different processing methods to create unique surface properties. The stents were implanted into iliac arteries of minipigs for six months and explanted for corrosion analysis. Scanning electron microscopy and energy dispersive X-ray spectrometry analyses indicated that stents with a thick complex thermal oxide (420nm) and high corrosion resistance in-vitro (Eb=975±94mV) were free from detectable corrosion in-vivo and exhibited no changes in Ni/Ti ratio when compared to non-implanted controls. This result was also found in mechanically polished stents with a thin native oxide (4nm; Eb=767±226mV). In contrast, stents with a moderately thick thermal oxide (130nm) and low corrosion resistance in-vitro (Eb=111±63mV) possessed corrosion with associated surface microcracks in-vivo. In addition, Ni/Ti ratios in corroded regions were significantly lower compared to non-corroded adjacent areas on explanted stents. When stents were minimally processed (i.e. retained native tube oxide from the drawing process), a thick thermal oxide was present (399nm) with low in-vitro corrosion resistance (Eb=68±29mV) resulting in extensive in-vivo pitting. These findings demonstrate that functional corrosion testing combined with a detailed understanding of the surface characteristics of a Nitinol medical device can provide insight into in-vivo corrosion resistance. Nitinol is a commonly used material in the medical device industry. However, correlations between surface processing of nitinol and in-vivo corrosion has yet to be established. Elucidating the link between in

  18. Use of Micropatterned Thin Film Nitinol in Carotid Stents to Augment Embolic Protection

    PubMed Central

    Shayan, Mahdis; Jankowitz, Brian T.; Shridhar, Puneeth; Chun, Youngjae

    2016-01-01

    Stenting is an alternative to endarterectomy for the treatment of carotid artery stenosis. However, stenting is associated with a higher risk of procedural stroke secondary to distal thromboembolism. Hybrid stents with a micromesh layer have been proposed to address this complication. We developed a micropatterned thin film nitinol (M-TFN) covered stent designed to prevent thromboembolism during carotid intervention. This innovation may obviate the need or work synergistically with embolic protection devices. The proposed double layered stent is low-profile, thromboresistant, and covered with a M-TFN that can be fabricated with fenestrations of varying geometries and sizes. The M-TFN was created in multiple geometries, dimensions, and porosities by sputter deposition. The efficiency of various M-TFN to capture embolic particles was evaluated in different atherosclerotic carotid stenotic conditions through in vitro tests. The covered stent prevented emboli dislodgement in the range of 70%–96% during 30 min duration tests. In vitro vascular cell growth study results showed that endothelial cell elongation, alignment and growth behaviour silhouettes significantly enhance, specifically on the diamond-shape M-TFN, with the dimensions of 145 µm × 20 µm and a porosity of 32%. Future studies will require in vivo testing. Our results demonstrate that M-TFN has a promising potential for carotid artery stenting. PMID:27983574

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

    PubMed

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

    2016-03-01

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

  20. Implantation study of a tissue-engineered self-expanding aortic stent graft (bio stent graft) in a beagle model.

    PubMed

    Kawajiri, Hidetake; Mizuno, Takeshi; Moriwaki, Takeshi; Iwai, Ryosuke; Ishibashi-Ueda, Hatsue; Yamanami, Masashi; Kanda, Keiichi; Yaku, Hitoshi; Nakayama, Yasuhide

    2015-03-01

    The use of stent grafts for endovascular aortic repair has become an important treatment option for aortic aneurysms requiring surgery. This treatment has achieved excellent outcomes; however, problems like type 1 endoleaks and stent graft migration remain. Bio stent grafts (BSGs), which are self-expanding stents covered with connective tissue, were previously developed using "in-body tissue architecture" technology. We assessed their early adaptation to the aorta after transcatheter implantation in a beagle model. BSGs were prepared by subcutaneous embedding of acryl rods mounted with self-expanding nitinol stents in three beagles for 4 weeks (n = 3/dog). The BSGs were implanted as allografts into infrarenal abdominal aortas via the femoral artery of three other beagles. After 1 month of implantation, aortography revealed no stenosis or aneurysmal changes. The luminal surface of the BSGs was completely covered with neointimal tissue, including endothelialization, without any thrombus formation. The cover tissue could fuse the luminal surface of the native aorta with tight conjunctions even at both ends of the stents, resulting in complete impregnation of the strut into the reconstructed vascular wall, which is expected to prevent endoleaks and migration in clinical applications.

  1. Relationship Between Primary Patency and Lesion Length Following Bare Nitinol Stent Placement for Femoropopliteal Disease.

    PubMed

    Soga, Yoshimitsu; Takahara, Mitsuyoshi; Iida, Osamu; Suzuki, Kenji; Hirano, Keisuke; Kawasaki, Daizo; Shintani, Yoshiaki; Yamaoka, Terutoshi; Ando, Kenji

    2015-12-01

    To evaluate the relationship between 1-year primary patency and lesion length in patients with femoropopliteal disease treated with bare nitinol stents. The study was a retrospective analysis of a prospectively maintained multicenter database. Between January 2004 and December 2011, 1047 consecutive patients (mean age 72 years; 765 men) underwent femoropopliteal stenting with nitinol stents in 1373 limbs. The mean vessel diameter was 5.3±0.7 mm and the mean lesion length was 142±75 mm. One-year follow-up data were collected and analyzed to ascertain which lesion length would be expected to demonstrate a 1-year primary patency above the established 66% objective performance goal (OPG). The lower limit of the 95% confidence interval (CI) for the unadjusted 1-year primary patency was >66% when the lesion length was ≤243 mm. After adjustment of the covariates to match those of the OPG-derived population, the 1-year primary patency decreased linearly with longer lesion length. The 1-year primary patency was 83.2% (95% CI 79.8% to 86.1%) for a 100-mm lesion length, 76.4% (95% CI 71.7% to 80.5%) for a 200-mm lesion length, and 70.7% (95% CI 62.4% to 77.7%) for a 300-mm lesion length. The maximum lesion length providing a 1-year primary patency significantly greater than 66% was calculated to be 263 mm. The 1-year primary patency of femoropopliteal lesions treated with bare nitinol stents decreased linearly with longer lesion length. The maximum lesion length providing a higher patency rate than the OPG of 66% was ~25 cm. © The Author(s) 2015.

  2. Evolution of patency rates of self-expandable bare metal stents for endovascular treatment of femoro-popliteal arterial occlusive disease: Does stent design matter?

    PubMed

    Treitl, Karla Maria; Woerner, Benedikt; Schinner, Regina; Czihal, Michael; Notohamiprodjo, Susan; Hoffmann, Ulrich; Treitl, Marcus

    2017-09-01

    To analyse the patency rates of femoro-popliteal stenting with different self-expandable Nitinol stent-designs. Two hundred and twenty-two patients (142 (64%) male; age 72.4 ± 11.6 years) with symptomatic femoro-popliteal peripheral arterial occlusive disease (PAOD) underwent percutaneous transluminal angioplasty (PTA) and stenting with three different Nitinol stents (interwoven IW: n = 70; closed-cell CC: n = 85; open-cell OC: n = 67). One-year post-procedural target lesion revascularization (TLR_12M) rates were investigated with regard to co-morbidities: diabetes (DBM), hyperlipidaemia (HLP), hypertension (RR), coronary artery disease (CAD) and degree of calcification. Twelve-month follow-up data were available for 60, 69 and 50 patients in the IW, OC and CC groups (179 patients in total). The cumulative patency (IW: 52 (86.7%); OC: 50 (72.5%); CC: 23 (46.0%); P < 0.001) and the TLR_12M rates (IW: 8 (13.3%); OC: 19 (27.5%); CC: 27 (54.0%); P < 0.001) differed significantly, as did the subgroup analyses (DBM: P = 0.05; RR: P = 0.003; HLP: P = 0.005; CAD: P = 0.02; localization: P < 0.001; calcification: P < 0.001), with the best patency for the IW stent and the highest TLR_12M for the CC stent. The interwoven stent-design was superior to the standard open- and closed-cell stent-designs in endovascular treatment of femoro-popliteal PAOD in a follow-up period of 12 months. • Results of femoro-popliteal stenting are still unsatisfactory. • Comparative studies for currently available different Nitinol stent-designs are lacking. • This is a first comparative study on long-term patency of different Nitinol stent-designs. • Interwoven stent-design leads to improved long-term patency. • Interwoven stent-design leads to lower TLR than other stent-designs.

  3. Effects of tissue digestion solutions on surface properties of nitinol stents.

    PubMed

    Sullivan, Stacey J L; Stafford, Philip; Malkin, Elon; Dreher, Maureen L; Nagaraja, Srinidhi

    2017-02-02

    Analysis of explanted medical implants can provide a wealth of knowledge about device safety and performance. However, the quality of information may be compromised if the methods used to clean tissue from the device disturb the retrieved condition. Common solutions used to digest tissue may adversely affect the surface of the device and its severity can be material and processing dependent. In this study, two groups of stents made from the same material (Nitinol) were shape set in a salt pot (SP) or further processed by mechanical polishing (MP) and then immersed in one of three tissue digestion solutions (TDS): nitric acid (HNO3 ), sodium hydroxide (NaOH), or papain enzyme (papain). Nickel (Ni) ion concentrations were measured for each stent-TDS combination and post-immersion stent surface constituents, morphology and oxide depths were compared to baseline samples. Exposure to the HNO3 TDS resulted in relatively high Ni ion release and surface damage for both stent types. Papain TDS induced a greater Ni ion release than NaOH TDS, however, both were significantly lower than HNO3 . The NaOH TDS increased the oxide layer thickness on MP stents. In contrast, all other stent immersions resulted in thinner oxide layers. For the Nitinol finishes used in this study, HNO3 is not recommended while papain and NaOH solutions may be appropriate depending on the post-retrieval analysis performed. This study elucidates the importance of preliminary testing for TDS selection and how the surface finish can affect the sensitivity of a material to a TDS. 2017 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 2017.

  4. Use of Nitinol Stents Following Recanalization of Central Venous Occlusions in Hemodialysis Patients

    SciTech Connect

    Rajan, Dheeraj K. Saluja, Jasdeep S.

    2007-07-15

    Purpose. To retrospectively review the patency of endovascular interventions with nitinol stent placement for symptomatic central venous occlusions in hemodialysis patients. Methods. A retrospective review of all patients who underwent endovascular interventions for dysfunctional hemodialysis grafts and fistulas was performed from April 2004 to August 2006. A total of 6 patients presented with arm and/or neck and facial swelling and left brachiocephalic vein occlusion. The study group consisted of 3 men and 3 women with a mean age of 79.5 years (SD 11.2 years). Of these 6 patients, 1 had a graft and 5 had fistulas in the left arm. The primary indication for nitinol stent placement was technical failure of angioplasty following successful traversal of occluded central venous segments. Patency was assessed from repeat fistulograms and central venograms performed when patients redeveloped symptoms or were referred for access dysfunction determined by the ultrasound dilution technique. No patients were lost to follow-up. Results. Nitinol stent placement to obtain technically successful recanalization of occluded venous segments was initially successful in 5 of 6 patients (83%). In 1 patient, incorrect stent positioning resulted in partial migration to the superior vena cava requiring restenting to prevent further migration. Clinical success was observed in all patients (100%). Over the follow-up period, 2 patients underwent repeat intervention with angioplasty alone. Primary patency was 83.3% (95% CI 0.5-1.2) at 3 months, and 66.7% at 6 and 12 months (0.2-1.1, 0.1-1.2). Secondary patency was 100% at 12 months with 3 patients censored over that time period. Mean primary patency was 10.4 months with a mean follow-up of 12.4 months. No complications related to recanalization of the occluded central venous segments were observed. Conclusion. Our initial experience has demonstrated that use of nitinol stents for central venous occlusion in hemodialysis patients is

  5. Use of nitinol stents following recanalization of central venous occlusions in hemodialysis patients.

    PubMed

    Rajan, Dheeraj K; Saluja, Jasdeep S

    2007-01-01

    To retrospectively review the patency of endovascular interventions with nitinol stent placement for symptomatic central venous occlusions in hemodialysis patients. A retrospective review of all patients who underwent endovascular interventions for dysfunctional hemodialysis grafts and fistulas was performed from April 2004 to August 2006. A total of 6 patients presented with arm and/or neck and facial swelling and left brachiocephalic vein occlusion. The study group consisted of 3 men and 3 women with a mean age of 79.5 years (SD 11.2 years). Of these 6 patients, 1 had a graft and 5 had fistulas in the left arm. The primary indication for nitinol stent placement was technical failure of angioplasty following successful traversal of occluded central venous segments. Patency was assessed from repeat fistulograms and central venograms performed when patients redeveloped symptoms or were referred for access dysfunction determined by the ultrasound dilution technique. No patients were lost to follow-up. Nitinol stent placement to obtain technically successful recanalization of occluded venous segments was initially successful in 5 of 6 patients (83%). In 1 patient, incorrect stent positioning resulted in partial migration to the superior vena cava requiring restenting to prevent further migration. Clinical success was observed in all patients (100%). Over the follow-up period, 2 patients underwent repeat intervention with angioplasty alone. Primary patency was 83.3% (95% CI 0.5-1.2) at 3 months, and 66.7% at 6 and 12 months (0.2-1.1, 0.1-1.2). Secondary patency was 100% at 12 months with 3 patients censored over that time period. Mean primary patency was 10.4 months with a mean follow-up of 12.4 months. No complications related to recanalization of the occluded central venous segments were observed. Our initial experience has demonstrated that use of nitinol stents for central venous occlusion in hemodialysis patients is associated with good mid-term patency and may

  6. Patient-level meta-analysis of 999 claudicants undergoing primary femoropopliteal nitinol stent implantation.

    PubMed

    Rocha-Singh, Krishna J; Beckman, Joshua A; Ansel, Gary; Lyden, Sean P; Schneider, Peter; Mehta, Manish; Dake, Michael; Mullin, Christopher M; Jaff, Michael R

    2017-06-01

    The factors that impact the clinical effectiveness of bare nitinol stents in claudicants with symptomatic femoropopliteal atherosclerosis are incompletely known. The authors analyzed variables that may influence stent durability and provide a benchmark for their effectiveness. Data analyzed from six studies (999 patients) included baseline noninvasive hemodynamic tests, angiographic characteristics, ultrasound defined stent patency and target lesion revascularization through 12-months. Baseline ankle-brachial index and lesion length predicted stent patency and target lesion revascularization and when combined interacted significantly to better predict outcomes. This meta-analysis provides an important comparator against which emerging therapies that treat claudicants with femoropopliteal atherosclerosis can be assessed. Peripheral Artery Disease BACKGROUND: The performance of bare metal nitinol stents in patients with symptomatic femoropopliteal peripheral artery disease (PAD) is not well defined. Patient-level data from six large prospective trials sponsored by medical device manufacturers was abstracted and analyzed to identify a cohort of patients with claudication and femoropopliteal artery occlusive disease. Twelve-month binary patency and target lesion revascularization (TLR) rates were primary outcomes. Stent patency was assessed by duplex ultrasonography (DUS) and TLR was a clinically driven intervention. To characterize the effects of patient characteristics on the outcomes, meta-regression was performed via mixed effects logistic regression models with patient-level covariates. About 999 patients were analyzed; the mean ABI was 0.68 ± 0.18, the mean lesion length was 84 ± 53 mm, the mean lesion stenosis was 78%, and nearly two thirds of patients had mild to severe calcification. The mean Rutherford clinical category was 2.7 ± 0.6 and ranged from 2.6 to 2.8 in all studies. The 12-month patency across all studies was 69.8% and TLR rates

  7. A newly designed big cup nitinol stent for gastric outlet obstruction

    PubMed Central

    Shi, Ding; Liao, Sheng-Hui; Geng, Jian-Ping

    2010-01-01

    AIM: To find out whether a newly designed big cup nitinol stent is suitable for treatment of patients with gastric outlet obstruction resulting from gastric cancer. METHODS: The new stent is composed of a proximal big cup segment (20 mm in length and 48-55 mm in diameter), a middle part (60 mm in length and 20 mm in diameter) covered by a polyethylene membrane and a distal sphericity (20 mm in length and 28 mm in diameter). Half of the proximal big cup segment is also covered by a polyethlene membrane, which is adjacent to the middle part of the stent. The stent is preloaded in a 6.0-mm-diameter introducer system. Thirteen patients with gastric outlet obstruction resulting from gastric cancer received the new stents under endoscopic and fluoroscopic guidance. RESULTS: Technical success was achieved in 12 of 13 (92.3%) patients. Among the 12 patients in whom endoscopic stent was placed successfully, the clinical success rate was 91.7% during a follow-up of average 6.5 mo. During the first month follow-up, the migration rate was 0%, recurrent obstruction 0% and gastric bleeding 8.3%. During the follow-up between 2-12 mo, no migration, recurrent obstruction and gastric bleeding occurred. CONCLUSION: The proximal big cup segment seems to be effective and promising for technical efficacy, clinical outcome, and preventing migration and tumor ingrowth and increasing the emptying rate of sinus ventriculi. PMID:20806440

  8. Accelerated in vitro durability testing of nonvascular Nitinol stents based on the electrical potential sensing method

    NASA Astrophysics Data System (ADS)

    Park, Chan-Hee; Tijing, Leonard D.; Pant, Hem Raj; Kim, Tae-Hyung; Amarjargal, Altangerel; Kim, Han Joo; Kim, Cheol Sang

    2013-09-01

    In this paper, we report an evaluation of the performance of a new stent durability tester based on the electrical potential sensing method through accelerated in vitro testing of six different nonvascular Nitinol stents simulating physiological conditions. The stents were subjected to a pulsatile loading of 33 Hz for a total of 62,726,400 cycles, at constant temperature and pressure of 35±0.5 °C and 120±4 mmHg, respectively. The electrical potential of each stent was measured in real-time and monitored for any changes in readings. After conducting test-to-fracture tests, the stents were visually checked, and by scanning electron microscopy. A sudden electrical potential drop in the readings suggests a fracture has occurred, and the only two instances of fracture in our present results were correctly determined by our present device, with the fractures confirmed visually after the test. The excellent performance of our new method shows good potential for a highly reliable and applicable in vitro durability testing for different kinds and sizes of metallic stents.

  9. Picosecond laser micromachining of nitinol and platinum-iridium alloy for coronary stent applications

    NASA Astrophysics Data System (ADS)

    Muhammad, N.; Whitehead, D.; Boor, A.; Oppenlander, W.; Liu, Z.; Li, L.

    2012-03-01

    The demand for micromachining of coronary stents by means of industrial lasers rises quickly for treating coronary artery diseases, which cause more than one million deaths each year. The most widely used types of laser for stent manufacturing are Nd:YAG laser systems with a wavelength of 1064 nm with pulse lengths of 10-3-10-2 seconds. Considerable post-processing is required to remove heat-affected zones (HAZ), and to improve surface finishes and geometry. Using a third harmonic laser radiation of picosecond laser (6×10-12 s pulse duration) in UV range, the capability of the picosecond laser micromachining of nitinol and platinum-iridium alloy for coronary stent applications are presented. In this study dross-free cut of nitinol and platinum-iridium alloy tubes are demonstrated and topography analysis of the cut surface is carried out. The HAZ characteristics have been investigated by means of microscopic examinations and measurement of micro-hardness distribution near the cut zones.

  10. Drug-coated balloons are replacing the need for nitinol stents in the superficial femoral artery.

    PubMed

    Kitrou, Panagiotis; Karnabatidis, Dimitrios; Katsanos, Konstantinos

    2016-08-01

    Amassed evidence from several randomized controlled trials and high quality meta-analyses clearly support the primary use of paclitaxel-coated balloons (PCB) in the superficial femoral artery over traditional plain balloon angioplasty or primary bare nitinol stenting with significantly lower vascular restenosis, less need for repeat procedures, improved quality of life and potential cost savings for the healthcare system. Stents may be reserved for bail-out in case of a suboptimal dilatation result, and for selected more complex lesions, or in case of critical limb ischemia in order to eliminate vessel recoil and maximize immediate hemodynamic gain. Debulking atherectomy remains unproven, but holds a lot of promise in particular in combination with PCBs, in order to improve compliance of the vessel wall by plaque removal, allow for a better angioplasty result and optimize drug transfer and bioavailability. The present overview summarizes and discusses current evidence about femoropopliteal PCB angioplasty compared to the historical standard of plain old balloon angioplasty and bare nitinol stents. Available evidence is appraised in the context of clinically meaningful results, relevant unresolved issues are highlighted, and future trends are discussed.

  11. Drug-eluting and bare nitinol stents for the treatment of atherosclerotic lesions in the superficial femoral artery: long-term results from the SIROCCO trial.

    PubMed

    Duda, Stephan H; Bosiers, Marc; Lammer, Johannes; Scheinert, Dierk; Zeller, Thomas; Oliva, Vincent; Tielbeek, Alexander; Anderson, John; Wiesinger, Benjamin; Tepe, Gunnar; Lansky, Alexandra; Jaff, Michael R; Mudde, Catharina; Tielemans, Hans; Beregi, Jean-Paul

    2006-12-01

    To review clinical outcomes of patients with chronic limb ischemia and TASC type C lesions treated with sirolimus-eluting versus bare SMART nitinol self-expanding stents. Data were obtained from a randomized, multicenter, double-blinded study conducted in 2 phases. All 93 patients had chronic limb ischemia and superficial femoral artery (SFA) occlusions or stenoses (average lesion length 8.3 cm). In total, 47 patients (31 men; mean age 66.3+/-9.1 years, range 50-84) received the sirolimus-eluting SMART stent and 46 patients (36 men; mean age 65.9 +/-10.8 years, range 38-83) received a bare SMART nitinol stent. Both groups were followed for a mean 24 months. Both the sirolimus-eluting and the bare SMART stents were effective in revascularizing the diseased SFA and in sustaining freedom from restenosis. For both types of stents, improvements in ankle-brachial indices (ABI) and symptoms of claudication were maintained over 24 months (median 24-month ABI 0.96 for the sirolimus group versus 0.87 for the bare stent group, p>0.05). At 24 months, the restenosis rate in the sirolimus group was 22.9% versus 21.1% in the bare stent group (p>0.05). The cumulative in-stent restenosis rates according to duplex ultrasound were 4.7%, 9.0%, 15.6%, and 21.9%, respectively, at 6, 9, 18, and 24 months; the rates did not differ significantly between the treatment groups. The TLR rate for the sirolimus group was 6% and for the bare stent group 13%; the TVR rates were somewhat higher: 13% and 22%, respectively. Mortality rates did not differ significantly between the groups. These data demonstrate that the sirolimus-eluting and the bare SMART stent are effective, safe, and free from restenosis in a majority of patients for up to 24 months. Because the restenosis rate in the bare stent group is unexpectedly low, no significant difference could be found between the sirolimus-eluting and the bare SMART stents.

  12. Mechanical modeling of self-expandable stent fabricated using braiding technology.

    PubMed

    Kim, Ju Hyun; Kang, Tae Jin; Yu, Woong-Ryeol

    2008-11-14

    The mechanical behavior of a stent is one of the important factors involved in ensuring its opening within arterial conduits. This study aimed to develop a mechanical model for designing self-expandable stents fabricated using braiding technology. For this purpose, a finite element model was constructed by developing a preprocessing program for the three-dimensional geometrical modeling of the braiding structure inside stents, and validated for various stents with different braiding structures. The constituent wires (Nitinol) in the braided stents were assumed to be superelastic material and their mechanical behavior was incorporated into the finite element software through a user material subroutine (VUMAT in ABAQUS) employing a one-dimensional superelastic model. For the verification of the model, several braided stents were manufactured using an automated braiding machine and characterized focusing on their compressive behavior. It was observed that the braided stents showed a hysteresis between their loading and unloading behavior when a compressive load was applied to the braided tube. Through the finite element analysis, it was concluded that the current mechanical model can appropriately predict the mechanical behavior of braided stents including such hysteretic behavior, and that the hysteresis was caused by the slippage between the constituent wires and their superelastic property.

  13. Balloon-expandable Metallic Stents for Airway Diseases.

    PubMed

    Ohki, Takashi; Sugimoto, Seiichiro; Kurosaki, Takeshi; Otani, Shinji; Miyoshi, Kentaroh; Yamane, Masaomi; Miyoshi, Shinichiro; Oto, Takahiro

    2016-10-01

    Stent placement is an essential treatment for airway diseases. Although self-expandable metallic stents and silicone stents are commonly applied for the treatment of airway diseases, these stents are unsuitable for the treatment of small airway diseases encountered in pediatric patients and lung transplant recipients with airway complications. Currently, only vascular balloon-expandable metallic stents are available for the treatment of small airway diseases; however, little research has been conducted on the use of these stents in this field. We have launched a prospective feasibility study to clarify the safety and efficacy of balloon-expandable metallic stents for the treatment of airway diseases.

  14. Use of a nitinol stent to palliate a colorectal neoplastic obstruction in a dog

    PubMed Central

    Culp, William T. N.; MacPhail, Catriona M.; Perry, James A.; Jensen, Tracey D.

    2015-01-01

    Case Description A 12-year-old castrated male Labrador Retriever was evaluated for clinical signs associated with colorectal obstruction. Clinical Findings The dog had a 2-week history of tenesmus and hematochezia. On rectal examination, an annular colorectal mass was palpable extending orad into the pelvic canal. The original diagnosis of the colorectal mass was a mucosal adenoma. The dog was maintained on a low-residue diet and fecal softeners for a period of 13 months after initial diagnosis. At that time, medical management was no longer effective. Treatment and Outcome Placement of a colonic stent was chosen to palliate the clinical signs associated with colorectal obstruction. By use of fluoroscopic and colonoscopic guidance, a nitinol stent was placed intraluminally to open the obstructed region. Placement of the stent resulted in improvement of clinical signs, although tenesmus and obstipation occurred periodically after stent placement. At 212 days after stent placement, the patient had extensive improvement in clinical signs with minimal complications; however, clinical signs became severe at 238 days after stent placement, and the dog was euthanized. Histologic evaluation of the rectal tumor from samples obtained during necropsy revealed that the tumor had undergone malignant transformation to a carcinoma in situ. Clinical Relevance A stent was successfully placed in the colon and rectum to relieve obstruction associated with a tumor originally diagnosed as a benign neoplasm. Placement of colorectal stents may be an option for the palliation of colorectal obstruction secondary to neoplastic disease; however, clinical signs may persist, and continuation of medical management may be necessary. PMID:21756178

  15. Reduced thrombogenicity of nitinol stents--in vitro evaluation of different surface modifications and coatings.

    PubMed

    Tepe, Gunnar; Schmehl, Joerg; Wendel, Hans P; Schaffner, Sivio; Heller, Stephan; Gianotti, Marc; Claussen, Claus D; Duda, Stephan H

    2006-02-01

    The material and the surface patterns of intravascular stents play a pivotal role in activating platelets and triggering adherence of inflammatory cells that consecutively leads to renarrowing caused by neointimal hyperplasia. To improve these features, besides mechanical and chemical modifications, ways of masking the stent by covering have been developed. In addition, polymer-coated stents are used as vehicle for local drug delivery. But as substances used for this application are described to possess an inflammatory potential, this aspect has to be evaluated. In the present study we compared different approaches to surface alterations applied to a nitinol stent design. Besides commonly used techniques like passivation and electropolishing, we evaluated coatings with heparin, aluminium and a polyurethane polymer regarding their thrombogenic and inflammatory characteristics. By weaving thin elastomer fibres a graft was generated. The previously described Chandler loop was used to simulate arterial flow conditions ex vivo using rotating PVC tubings filled with human blood. All stents received 120 min of blood contact. To determine thrombocyte activation and inflammatory reaction, the platelet count and levels of beta-TG, TAT and PMN-elastase were assessed. Scanning electron microscopy was used to visualize the reactions. Mechanical polishing and passivation did not improve the stent surface characteristics while sandblasting, electropolishing and aluminium covering decreased activation of the coagulation cascade. In terms of thrombogenicity, the heparin coating had no beneficial effect. The lowest thrombogenic potential was found in the Polyurethane-coated stent group. All stents showed similar levels of polymorph nuclear granulocyte elastase except for the membrane design. While mechanical and chemical modifications are able to reduce thrombogenicity, coating with this particular polyurethane polymer seems to be superior to these approaches regarding the

  16. Superficial femoral artery TASC D Registry: twelve-month effectiveness analysis of the Pulsar-18 SE nitinol stent in patients with critical limb ischemia.

    PubMed

    Lichtenberg, M; Stahlhoff, W; Boese, D

    2013-08-01

    Single center observational study analyzing the primary patency rate and freedom from target lesions revascularization rate of the Pulsar-18 nitinol stent after recanalization of long superficial femoral artery (SFA) occlusions (TASC D) in 22 patients with critical limb ischemia (CLI). Between 1/2011 and 7/2011, 22 consecutive patients (9 male, 13 female) with chronic total occlusions (CTO) of the femoro-popliteal arteries presenting with CLI (17 patients with Rutherford 4 score, and 5 patients with Rutherford 5 score) were enrolled and successfully recanalized using the Pulsar-18 self-expanding (SE) nitinol stent (BIOTRONIK AG, Buelach, Switzerland). Primary patency at 12 months was defined as no binary restenosis (>50%) on Duplex ultrasound (PSVR<2.5) and respectively no target lesion revascularization performed within 12 months. The average lesion length of the treated femoro-popliteal segment was 315 mm. Performing spot stenting average stent length in all patients was 245 mm (minimal 215 mm, maximal 315 mm). Technical success, with establishing an antegrade straight line flow to the foot through a reopened SFA, was achieved in all 22 patients. Subintimal and intraluminal recanalization techniques were used. Two patients with Rutherford 5 score had a minor amputation shortly after the recanalization procedure. All other patients had a complete wound healing of their lesions during a 6 month follow-up. After 12 month follow-up the primary patency rate of the Pulsar-18 SE nitinol stent was 77% with a per protocol restenosis in 5 of 22 patients. Seventeen patients showed a walking capacity on treadmill test >300 meters (Rutherford II). Two patients with a documented restenosis were Rutherford, these patients were treated conservatively. Three patients with restenosis and a Rutherford III score were scheduled for an endovascular target lesion revascularization leading to a freedom from target lesion revascularization rate of 86%. Endovascular intervention of long

  17. Development of tissue-engineered self-expandable aortic stent grafts (Bio stent grafts) using in-body tissue architecture technology in beagles.

    PubMed

    Kawajiri, Hidetake; Mizuno, Takeshi; Moriwaki, Takeshi; Ishibashi-Ueda, Hatsue; Yamanami, Masashi; Kanda, Keiichi; Yaku, Hitoshi; Nakayama, Yasuhide

    2015-02-01

    In this study, we aimed to describe the development of tissue-engineered self-expandable aortic stent grafts (Bio stent graft) using in-body tissue architecture technology in beagles and to determine its mechanical and histological properties. The preparation mold was assembled by insertion of an acryl rod (outer diameter, 8.6 mm; length, 40 mm) into a self-expanding nitinol stent (internal diameter, 9.0 mm; length, 35 mm). The molds (n = 6) were embedded into the subcutaneous pouches of three beagles for 4 weeks. After harvesting and removing each rod, the excessive fragile tissue connected around the molds was trimmed, and thus tubular autologous connective tissues with the stent were obtained for use as Bio stent grafts (outer diameter, approximately 9.3 mm in all molds). The stent strut was completely surrounded by the dense collagenous membrane (thickness, ∼150 µm). The Bio stent graft luminal surface was extremely flat and smooth. The graft wall of the Bio stent graft possessed an elastic modulus that was almost two times higher than that of the native beagle abdominal aorta. This Bio stent graft is expected to exhibit excellent biocompatibility after being implanted in the aorta, which may reduce the risk of type 1 endoleaks or migration.

  18. Effect of Self-Expanding Carotid Stents on Plaque Thickness and Vessel Diameter.

    PubMed

    Martínez-Pérez, Rafael; Marchuk, Graeme; Lee, Donald H; Pelz, David M; Lownie, Stephen P

    2017-09-01

    In vitro models have suggested that stents affect atherosclerotic plaques symmetrically because of their outward radial forces. We evaluated the effects of stents on carotid plaque and the arterial wall using carotid ultrasound in carotid stenting patients to see whether these effects were borne out in vivo. From a carotid stent database, 30 consecutive patients were selected. All had carotid Doppler ultrasound performed pre- and poststenting. The diameters of the lumen at the level of stenotic plaque pre- and poststenting, the dorsal and ventral plaque thickness, and of the outer arterial wall diameter were measured. Plaque thickness was measured at the level of maximal stenosis. Nonparametric tests were used to determine whether the stent effect and luminal enlargement were based on wall remodeling or on total arterial expansion. The patients were followed for an average of 22 months. Eighteen patients were male, with an average age of 70 years. A total of 87% of patients were symptomatic ipsilateral to the side of stenosis. Nine patients had angioplasty intraprocedurally. The luminal diameter increased poststenting in the region of severe stenosis. Plaque thickness, both ventrally and dorsally, decreased poststenting, with no significant difference between the ventral and dorsal plaque effects. The outer arterial wall diameters did not change. The measured lumen in the stent increased over time poststenting. Self-expanding nitinol stents alter the baseline ventral and dorsal plaque to a significant degree and do not significantly affect the native arterial wall and the overall arterial diameter.

  19. Accelerated fatigue behavior and mechano-physical characterizations of in vitro physiological simulation of nitinol stents.

    PubMed

    Saidane, K; Polizu, S; Yahia, L'h

    2007-01-01

    In this study, we have provided an experimental evaluation of the fatigue behavior of the nitinol (NiTi) endovascular device (peripheral stent). The accelerated fatigue tests were performed using arterial conditions, which mimicked actual physiological conditions. Natural, rubber latex-tubing materials were used to simulate human arteries. The equipment design and the test parameters used allowed for the simulation of a compliant artery and the application of circumferential forces to the device.The stent compliance values were good indicators for tracking the time evolution of fatigue behavior. Moreover, the analyses of changes on the surface morphology and on the chemical composition were used to establish a relationship between surface characteristics and peripheral stent response during 400 million cycles, which is equivalent to 10 yrs of human life. In order to determine the influence of the accelerated fatigue, an evaluation of both mechanical and surface characteristics was carried out before and after testing using the following tests and methods, respectively: radial hoop testing (RH), scanning electron microscope analysis (SEM), auger electron spectroscopy (AES), atomic absorption spectroscopy (AAS), and X-ray photoelectron spectroscopy (XPS). Under these experimental conditions, the studies have shown that after 400 million cycles, the tested stents did not demonstrate any mechanical failure. Moreover, the surface did not undergo any changes in its chemical composition. However, we did observe an increase in roughness and signs of pitting corrosion.

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

    SciTech Connect

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

    2000-09-15

    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. A 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.

  1. Stent evolution for peripheral arterial disease.

    PubMed

    Lejay, A; Thaveau, F; Girsowicz, E; Georg, Y; Heim, F; Durand, B; Chakfé, N

    2012-02-01

    Endovascular treatment and stent implantation for peripheral arterial disease have been proposed for over 20 years. However, the first experiments with stainless stents were relatively disappointing. The first improvement consisted in the introduction of nitinol self-expanding stents. This technology allowed an initial improvement of clinical performances, but the first generation of nitinol stents demonstrated a relatively high rate of fractures. Better knowledge of arterial biomechanics and advances in technology allowed to propose a second generation of nitinol stents with improved flexibility, which decreased the rates of fracture. In-stent restenosis related to neointimal hyperplasia has also led to the development of new concepts to improve patency rates after stenting: drug-eluting stents (coated-stents), biodegradable stents, and covered stents. These technologies will help to treat more complex lesions in the future, but we are still waiting for results of ongoing studies.

  2. Performance goals and endpoint assessments for clinical trials of femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease.

    PubMed

    Rocha-Singh, Krishna J; Jaff, Michael R; Crabtree, Tami R; Bloch, Daniel A; Ansel, Gary

    2007-05-01

    This analysis proposes safety and performance goals for prospective single-arm trials of bare nitinol stents to treat patients with debilitating claudication associated with femoropopliteal (FP) atherosclerotic lesions. To date there have been no analyses of clinical trials data to set efficacy and safety benchmarks for new bare nitinol stents in the treatment of claudication from FP disease. Industry has been reluctant to sponsor studies of nitinol stents due to logistical barriers. VIVA Physician's, Inc. (VPI) analyzed subject-level data from the PTA control arm of three randomized FDA device trials conducted by industry. Subjects with Rutherford category 2-4 claudication and FP lesion lengths 4-15 cm with 12 month duplex ultrasound (DUS) assessment were identified. These data were combined with the results of a survey of the medical literature (1990-2006) for similar subjects. Analysis of the industry derived control arm PTA data identified 116 patients (mean lesion length 8.7 cm) with a 12 month DUS defined FP patency of 28%. A similar cohort of 191 patients was identified from the medical literature in which the 12-month vessel patency equaled 37%; from these combined patient cohorts, expected vessel patency for PTA was estimated to equal 33%. Based on the PTA performance efficacy rate of 33% derived from industry clinical trial data and the medical literature, and the requirement that the bare nitinol stent 12-month efficacy performance goal be set to equal twice this rate, the patency efficacy goal equals 66%. Additional information is provided on safety and other reporting standards and stent integrity evaluation for bare metal stents. (c) 2007 Wiley-Liss, Inc.

  3. Stent overlapping and geometric curvature influence the structural integrity and surface characteristics of coronary nitinol stents.

    PubMed

    Kapnisis, Konstantinos K; Halwani, Dina O; Brott, Brigitta C; Anderson, Peter G; Lemons, Jack E; Anayiotos, Andreas S

    2013-04-01

    Preliminary studies have revealed that some stents undergo corrosion and fatigue-induced fracture in vivo, with significant release of metallic ions into surrounding tissues. A direct link between corrosion and in-stent restenosis has not been clearly established; nonetheless in vitro studies have shown that relatively high concentrations of heavy metal ions can stimulate both inflammatory and fibrotic reactions, which are the main steps in the process of restenosis. To isolate the mechanical effects from the local biochemical effects, accelerated biomechanical testing was performed on single and overlapping Nickel-Titanium (NiTi) stents subjected to various degrees of curvature. Post testing, stents were evaluated using Scanning Electron Microscopy (SEM) to identify the type of surface alterations. Fretting wear was observed in overlapping cases, in both straight and curved configurations. Stent strut fractures occurred in the presence of geometric curvature. Fretting wear and fatigue fractures observed on stents following mechanical simulation were similar to those from previously reported human stent explants. It has been shown that biomechanical factors such as arterial curvature combined with stent overlapping enhance the incidence and degree of wear and fatigue fracture when compared to single stents in a straight tube configuration.

  4. Bare nitinol stent enabled recanalization of long-segment, chronic total occlusion of superficial femoral and adjacent proximal popliteal artery in diabetic patients presenting with critical limb ischemia.

    PubMed

    Taneja, Manish; Tay, Kiang Hiong; Dewan, Atul; Sebastian, Mathew G; Pasupathy, Shanker; Lin, Sheuh En; Teo, Terence; Lo, Richard; Tan, Seck Guan; Irani, Farah G; Tan, Bien Soo

    2010-01-01

    To evaluate our experience of limb salvage with bare nitinol stent enabled recanalization of long length occlusions of superficial femoral artery (SFA) and adjacent proximal popliteal artery (PPA) in diabetic patients. A total of 573 patients underwent 842 lower limb interventions from August 2006 to September 2008 at our institute. A retrospective review was done of diabetic patients undergoing recanalization of long length SFA/adjacent PPA (>10 cm) occlusions with self expanding bare nitinol stents evaluating their impact on limb salvage. Forty-four patients (mean age 65.2 years, M:F 25:19) underwent 49 long-length (>10 cm) SFA/PPA stenting procedures over a period of 26 months. Diabetics comprised 66% of patients (n=29, mean age: 63.7 years, M: F 19:10). The infrapopliteal distal run-off in this diabetic subgroup comprised one vessel (n=14/29, 48%), two vessels (n=12/29, 41%), and three vessels (n=3/29, 10%). The spectrum of critical limb ischemia included rest pain (n=8), ulcer (n=7) and gangrene (n=14). The lengths of occlusions recanalized were 10-39 cm. A total of 58 stents (individual length 10-17 cm, average diameter 6 mm, mean 2 stents per patient) were placed with average length of stented segment being 23.8 cm. Four patients had stents placed through ipsilateral popliteal artery approach with rest placed through femoral artery approach. Significant complications of the procedure included distal embolization (n=3) successfully managed with thrombolysis and popliteal arteriovenous fistula in one patient undergoing recanalization through popliteal approach, managed with covered stent placement. No procedure related mortality occurred during thirty-day follow-up period. All were followed up over an average duration of twelve months post-procedure. Three patients died due to associated medical conditions during this period. The following amputations were done on follow-up (three toe amputations, five forefoot amputations, three below-knee amputations, two

  5. In vitro fatigue-crack growth and fracture toughness behavior of thin-walled superelastic Nitinol tube for endovascular stents: A basis for defining the effect of crack-like defects.

    PubMed

    Robertson, Scott W; Ritchie, Robert O

    2007-02-01

    Endovascular stents made of the superelastic nickel-titanium alloy Nitinol are subjected in service to tens of millions of loading cycles and even "single-event" overloads, both of which can potentially result in fracture and/or complete failure of the device. A fracture-mechanics-based methodology can provide a means to quantify relevant material parameters critical to the design against such failures. However, there is a dearth of relevant experimental data in the literature on such fracture-mechanics-based approaches to fatigue in Nitinol; furthermore, that which does exist invariably pertains to product forms that are not appropriate for stent manufacture, e.g., bulk Nitinol bar and strip. Consequently, the current work is focused on characterizing in vitro both subcritical and critical crack growth (fatigue-crack growth and R-curve fracture toughness) behavior in thin-walled ( approximately 400microm thick) Nitinol tubing similar to that used for medical device manufacture (following shape-setting procedures to flatten the material), with a resultant austenite finish temperature of A(f) approximately 25-30 degrees C, identical to self-expanding Nitinol stents. Fatigue-crack growth behavior, measured in Hanks' Balanced Saline Solution over a wide spectrum of growth rates (down to 10(-10)m/cycle) and at a range of positive load ratios (R=0.1-0.7), revealed significantly higher fatigue thresholds than had been previously reported for bulk Nitinol material. In addition, we examine the critical effect of test frequency, as most fatigue experiments on Nitinol have been performed at 30Hz or above, despite the fact that this is far in excess of the frequency of physiological loading. Finally, the fracture toughness properties are characterized in thin-section Nitinol and show marked crack-resistance (R-curve) behavior with a dependence on crack-growth angle (with respect to the tube drawing axis); additionally, measured toughnesses are found to be lower than has been

  6. Functional Self-Expandable Metal Stents in Biliary Obstruction

    PubMed Central

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

    2013-01-01

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

  7. Underwater femtosecond laser micromachining of thin nitinol tubes for medical coronary stent manufacture

    NASA Astrophysics Data System (ADS)

    Muhammad, Noorhafiza; Li, Lin

    2012-06-01

    Microprofiling of medical coronary stents has been dominated by the use of Nd:YAG lasers with pulse lengths in the range of a few milliseconds, and material removal is based on the melt ejection with a high-pressure gas. As a result, recast and heat-affected zones are produced, and various post-processing procedures are required to remove these defects. This paper reports a new approach of machining stents in submerged conditions using a 100-fs pulsed laser. A comparison is given of dry and underwater femtosecond laser micromachining techniques of nickel-titanium alloy (nitinol) typically used as the material for coronary stents. The characteristics of laser interactions with the material have been studied. A femtosecond Ti:sapphire laser system (wavelength of 800 nm, pulse duration of 100 fs, repetition rate of 1 kHz) was used to perform the cutting process. It is observed that machining under a thin water film resulted in no presence of heat-affected zone, debris, spatter or recast with fine-cut surface quality. At the optimum parameters, the results obtained with dry cutting showed nearly the same cut surface quality as with cutting under water. However, debris and recast formation still appeared on the dry cut, which is based on material vaporization. Physical processes involved during the cutting process in a thin water film, i.e. bubble formation and shock waves, are discussed.

  8. Structural Evaluation of Radially Expandable Cardiovascular Stents Encased in a Polyurethane Film

    NASA Technical Reports Server (NTRS)

    Trigwell, Steve; De, Samiran; Sharma, Rajesh; Mazumder, Malay K.; Mehta, Jawahar L.

    2004-01-01

    A method of encasing cardiovascular stents with an expandable polyurethane coating has been developed to provide a smooth homogeneous inner wall allowing for a confluent growth of endothelial cells. In this design, the metal wire stent structure is completely covered by the polyurethane film minimizing biocorrosion of the metal (stainless steel or nitinol), and providing a homogeneous surface for surface treatment and incorporation of various eluting drugs to prevent platelet aggregation while supporting endothelialization. The polyurethane surface was treated with a helium plasma for sterilization and promotes growth of cells. The paper details the performance of the coated film to expand with the metal stent up to 225 % during deployment. We present stress/strain behavior of polyurethane films, and subsequent plasma treatment of the surface and the adhesion of the coating to the stent structure upon expansion. A film of less than 25 tm was found to be sufficient for corrosion resistance and flexibility without producing any excess stress on the stent structure. Straining the film to 225 % and plasma modification did not affect the mechanical and surface properties while allowing for improved biocompatibility as determined by the critical surface tension, surface chemistry, and roughness.

  9. Structural evaluation of radially expandable cardiovascular stents encased in a polyurethane film.

    PubMed

    Trigwell, Steve; De, Samiran; Sharma, Rajesh; Mazumder, Malay K; Mehta, Jawahar L

    2006-02-01

    A method of encasing cardiovascular stents with an expandable polyurethane coating has been developed to provide a smooth homogeneous inner wall allowing for a confluent growth of endothelial cells. In this design, the metal wire stent structure is completely covered by the polyurethane film, minimizing biocorrosion of the metal (stainless steel or nitinol), and providing a homogeneous surface for surface treatment and incorporation of various eluting drugs to prevent platelet aggregation while supporting endothelialization. The polyurethane surface was treated with a helium plasma for sterilization and promotes growth of cells. The article details the performance of the coated film to expand with the metal stent up to 225% during deployment. Stress/strain behavior of polyurethane films, subsequent plasma treatment of the surface, and the adhesion of the coating to the stent structure upon expansion are presented. A film of less than 25 microm was found to be sufficient for corrosion resistance and flexibility without producing any excess stress on the stent structure. Straining the film to 225% and plasma modification did not affect the mechanical and surface properties, but allowed for improved biocompatibility as determined by the critical surface tension, surface chemistry, and roughness.

  10. Long-term resistance to fracture and/or corrosion of the nitinol wires of the talent stent-graft: observations from a series of explanted devices.

    PubMed

    Lin, Jing; Guidoin, Robert; Wang, Lu; Zhang, Ze; Paynter, Royston; How, Thien; Nutley, Mark; Wei, Dangheng; Douville, Yvan; Samis, Gregory; Dionne, Guy; Gilbert, Nathalie

    2013-01-01

    The biodurability of the Nitinol wires used in stent-grafts retrieved from reoperations and autopsy was analyzed to assess the possible causes of fracture and/or corrosion of the stents. The Nitinol wires of six explanted devices presented a corrosion-free surface after in vivo service. The drawing lines in the control wires were still present, but neither burrs nor flakes were observed. Pits and crevices were rare, but some shallow ones were present. Some abrasions of the surfaces of the Nitinol wires were also observed. The chemical composition of the explanted devices showed the presence of organic contamination that covered the thick layer of titanium oxide before reaching the Nitinol itself. The durability of the Nitinol employed in the manufacture of the Talent stent-grafts was confirmed; the results of this study show the Nitinol to be resistant to corrosion. We have also concluded that the fractures of the Nitinol wires in two devices were unique adverse incidents caused by compression and bending related to the sharp angle of the Nitinol wires.

  11. Clinical Outcomes of SMART Versus Luminexx Nitinol Stent Implantation for Aortoiliac Artery Disease: A Propensity Score-Matched Multicenter Study.

    PubMed

    Shintani, Yoshiaki; Soga, Yoshimitsu; Takahara, Mitsuyoshi; Iida, Osamu; Kawasaki, Daizo; Yamauchi, Yasutaka; Suzuki, Kenji; Hirano, Keisuke; Kawasaki, Tomohiro

    2015-10-01

    Endovascular therapy for aortoiliac (AI) lesions using stents is widely accepted. However, the long-term outcome of 2 different types of nitinol stents for AI lesions is unknown. The aim of this study was to examine the long-term outcome of the SMART and Luminexx nitinol stents for the treatment of de novo AI lesions. This study was a multicenter retrospective analysis of a prospectively maintained database. The study enrolled consecutive patients undergoing primary stenting for de novo AI artery stenosis between January 2005 and December 2009. A total of 1503 lesions in 1229 patients treated with SMART or Luminexx primary stenting were enrolled. The primary end point was primary patency, secondary end points were the primary assisted patency, secondary patency, and major adverse limb events (MALEs), which included major amputation and major reintervention. To minimize the differences between the groups, a propensity score matching analysis was performed, and 284 lesions per group were analyzed to identify outcomes. After the propensity score matching analysis, the lesion length was 60 ± 37 and 57 ± 31 mm (P = .275), and the reference vessel diameter was 8.2 ± 1.5 and 8.3 ± 1.5 mm (P = .482) in the SMART and Luminexx groups, respectively. The primary patency at 3 years was not significantly different between the groups (83.5% vs 82.2%, P = .842, respectively). The assisted primary patency and secondary patency rates were also not significantly different (91.7% vs 93.2%, P = .340, 99.2% vs 98.8%, P = .922). In addition, the MALE rate was not significantly different between the groups (98.3% vs 97.3%, P = .821). The current data suggest that the use of nitinol stents for the AI artery provided good long-term patency and freedom from MALE for 3 years of follow-up, regardless of whether SMART or Luminexx stents were used. © The Author(s) 2014.

  12. Self-expandable metal stents in malignant biliary obstruction.

    PubMed

    Jaganmohan, Sathya; Lee, Jeffrey H

    2012-02-01

    Malignant biliary obstruction can be due to direct tumor infiltration, extrinsic compression, adjacent inflammation, desmoplastic reaction from tumors or, more commonly, a combination of the above factors. Pancreatic cancer is the most common cause of malignant biliary obstruction, and jaundice occurs in 70-90% of the patients during the course of the disease. Compared with the uncovered metal stents, covered metal stents have longer patency and a lower rate of tumor ingrowth, but have a higher rate of stent migration. To combat the occlusion and provide an antitumor effect, drug-eluting stents were developed. A duodenal stricture complicates biliary stent placement in 10-20% of patients with distal biliary obstruction due to pancreatic cancer. When both strictures are considered, a biliary stent can be placed either preceding or following duodenal stent placement. Complications of self-expandable metal stents include stent occlusion, stent migration, cholecystitis and pancreatitis.

  13. Bayesian network meta-analysis of nitinol stents, covered stents, drug-eluting stents, and drug-coated balloons in the femoropopliteal artery.

    PubMed

    Katsanos, Konstantinos; Spiliopoulos, Stavros; Karunanithy, Narayan; Krokidis, Miltiadis; Sabharwal, Tarun; Taylor, Peter

    2014-04-01

    Several randomized controlled trials (RCTs) have shown the superiority of some of these technologies over balloon angioplasty, but direct comparisons between these treatment options are lacking. The authors conducted a network meta-analysis of RCTs comparing bare nitinol stents, covered nitinol stents, paclitaxel- or sirolimus-eluting stents (PES or SES), and paclitaxel-coated balloons (PCB) with plain balloon angioplasty or with each other in the femoropopliteal artery (PROSPERO registry: CRD42013004845). Sixteen RCTs comprising 2532 patients with 4227 person-years of follow-up were analyzed on an intention-to-treat basis. Bayesian random effects Poisson and binomial models were used for mixed treatment comparisons (WinBUGS). Clinical heterogeneity was accounted for by incorporating a meta-regression model on trial-specific baseline risk. End points included technical success, vascular restenosis, target lesion revascularization, and major amputations. Pairwise odds ratios and rate ratios (ORs and RRs) of absolute treatment effects were calculated, and the probabilities of each treatment being best are reported. Summary estimates are reported as the posterior median and associated credible intervals (CrIs) that serve the same purpose as confidence intervals in the context of the Bayesian framework. Extensive sensitivity, meta-regression, and network consistency analyses were performed to evaluate heterogeneity. Technical success was highest with covered stents (pooled OR, 13.6; 95% CrI, 3.3-31.1, probability best 82%) followed by uncovered stents (pooled OR, 7.0; 95% CrI, 2.6-129, probability best 18%) when compared with balloon angioplasty (reference treatment). Vascular restenosis was lowest with PES (RR, 0.43; 95% CrI, 0.16-1.18, probability best 45%) followed by PCB (RR, 0.43; 95% CrI, 0.26-0.67, probability best 42%). Target lesion revascularization was lowest with PCB (RR, 0.36; 95% CrI, 0.23-0.55, probability best 56%) followed by PES (RR, 0.42; 95% CrI, 0

  14. The EPIC nitinol stent system in the treatment of iliac artery lesions: one-year results from the ORION clinical trial.

    PubMed

    Clair, Daniel G; Adams, Julie; Reen, Bernard; Feldman, Robert; Starr, Jean; Diaz-Cartelle, Juan; Dawkins, Keith D

    2014-04-01

    To report the 1-year results of a pivotal study for a new-generation nitinol stent for the treatment of iliac atherosclerotic lesions. The ORION trial (ClinicalTrials.gov identifier NCT00896337) was a single-arm, non-randomized, prospective, multicenter clinical trial that enrolled 125 patients (81 men; mean age 61.1±9.3 years) implanted with the EPIC self-expanding nitinol stent system in 166 de novo or restenotic iliac artery lesions ≤13 cm long. The primary endpoint was the 9-month major adverse event rate [i.e., device- or procedure-related death within 30 days, myocardial infarction during the index hospitalization, target vessel revascularization (TVR), or index limb amputation]. Follow-up occurred at hospital discharge and at 1, 9, and 12 months. An independent core laboratory evaluated ultrasound results at 1, 9, and 12 months. The primary endpoint met the prespecified performance goal, with only 3.4% (4/117) of patients experiencing a major adverse event by 9 months (p<0.0001). By 12 months, 6 (5.4%) of 111 patients had TVR; none had an index limb amputation. The ankle-brachial index, Walking Impairment Questionnaire, and Rutherford classifications all showed sustained improvements through 12 months. Primary patency was 94.4% with comparable results for lesions classified as complex (TASC II C/D 95.5%) or non-complex (TASC II A/B 95.0%). The EPIC stent system demonstrated safety and effectiveness through 12 months, including improvements for complex lesions. The EPIC stent is a viable alternative to surgery for patients with either complex or non-complex lesions.

  15. Nitinol stent implantation for femoropopliteal disease in patients on hemodialysis: results of the 3-year retrospective multicenter APOLLON study.

    PubMed

    Fujihara, Masahiko; Higashimori, Akihiro; Kato, Yoshihiro; Taniguchi, Hiromasa; Iwasaki, Yusuke; Amano, Tomonori; Sumiyoshi, Akinori; Nishiya, Daisuke; Yokoi, Yoshiaki

    2016-09-01

    The clinical outcomes of nitinol stents for femoropopliteal arterial (FP) disease in patients on hemodialysis were assessed. Endovascular therapy (EVT) is accepted for symptomatic FP disease. However, the clinical outcomes of patients on dialysis are not well known. A multicenter retrospective study was conducted with data between November 2010 and August 2013. A total of 484 consecutive patients who successfully underwent EVT for FP disease with nitinol stents were recruited and analyzed. Patients were categorized into the hemodialysis group (N = 161) and non-hemodialysis group (N = 323). The primary measure was primary patency verified by duplex ultrasound at a rest peak systolic velocity (PSVR) of >2.5, and secondary measures were freedom from target lesion revascularization (TLR) and major amputation-free survival (AFS). Average follow-up duration was 19.5 ± 13.5 months. The primary patency rate at 3 years was significantly lower in the hemodialysis group than the non-hemodialysis group (33.8 vs. 43.7 %; p = 0.036). Freedom from TLR at 3 years was 55.0 % in the hemodialysis group and 66.1 % in the non-hemodialysis group (p = 0.032). The hemodialysis group showed a significantly lower AFS rate at 3 years than the non-hemodialysis group (86.4 vs. 58.2 %; p < 0.001). In hemodialysis patients, nitinol stent use resulted in a lower patency rate, higher TLR rate, and lower AFS rate compared to non-hemodialysis patients. These data suggest that nitinol stent implantation for FP arteries in hemodialysis patient needs to be reconsidered.

  16. Functionalized Non-vascular Nitinol Stent via Electropolymerized Polydopamine Thin Film Coating Loaded with Bortezomib Adjunct to Hyperthermia Therapy.

    PubMed

    Aguilar, Ludwig Erik; Tumurbaatar, Batgerel; Ghavaminejad, Amin; Park, Chan Hee; Kim, Cheol Sang

    2017-08-25

    Gastrointestinal malignancies have been a tremendous problem in the medical field and cover a wide variety of parts of the system, (i.e. esophagus, duodenum, intestines, and rectum). Usually, these malignancies are treated with palliation with the use of non-vascular nitinol stents. However, stenting is not a perfect solution for these problems. While it can enhance the quality of life of the patient, in time the device will encounter problems such as re-occlusion due to the rapid growth of the tumor. In this study, we propose a functionalization technique using electropolymerization of polydopamine directly onto the nitinol stent struts for the combined application of hyperthermia and chemotherapy. The coating was characterized using FESEM, XPS, and FT-IR. Drug release studies show that facile release of the anticancer drug BTZ from the surface of the polydopamine-coated stent could be achieved by the dissociation between catechol groups of polydopamine and the boronic acid functionality of BTZ in a pH-dependent manner. The anti-cancer property was also evaluated, and cytotoxicity on ESO26 and SNU-5 cancer cell lines were observed. Our results suggest that the introduced approach can be considered as a potential method for therapeutic stent application.

  17. Efficacy and complications in the use of self-expanding colonic stents: an analysis of 15 years' experience.

    PubMed

    Samper Wamba, J D; Fernández Martínez, A; González Pastrana, L; López González, L; Balboa Arregui, Ó

    2015-01-01

    To analyze the efficacy and safety of the procedure for placing self-expanding stents in the colon. To evaluate the factors associated with complications. To analyze the dose of radiation delivered in the procedure. This was a retrospective descriptive study of 478 procedures done at a single center to place self-expanding metallic stents in the colon. A total of 423 nitinol stents and 79 stainless steel stents were placed. We included all colonic obstructions, of which 446 had malignant causes and 8 had benign causes. We excluded patients with intestinal perforation, severe colonic bleeding, short life expectancy, or lesions located less than 5 cm from the anus. We collected the dosimetric data and analyzed the technical success, clinical success, and complications during follow-up. The procedure was a technical success in 92.26% of cases (n=441) and a clinical success in 78.45% (n=375); complications occurred during follow-up in 18.5% of cases. Complications occurred more frequently with the stainless steel stents than with the nitinol stents (OR: 3.2; 95% CI: 1.8-5.7). The mean value of the dose area product was 35 Gy*cm(2). When instead of being done by the interventional radiologist working together with an endoscopist the procedure was done exclusively by the interventional radiologist, the time under fluoroscopy (p=0.001), dose area product (p=0.029), and kinetic energy released per unit mass (p=0.001) were greater. The procedure for placing self-expanding colonic stents is efficacious and safe with an acceptable rate of complications. The doses of radiation delivered were low, and the radiation doses and time under fluoroscopy were lower when the procedure was done together with an endoscopist. Copyright © 2014 SERAM. Published by Elsevier España, S.L.U. All rights reserved.

  18. Nitinol stenting improves primary patency of the superficial femoral artery after percutaneous transluminal angioplasty in hemodialysis patients: a propensity-matched analysis.

    PubMed

    Kawamura, Yoshihiro; Ishii, Hideki; Aoyama, Toru; Tanaka, Miho; Takahashi, Hiroshi; Kumada, Yoshitaka; Toriyama, Takanobu; Murohara, Toyoaki

    2009-11-01

    Although percutaneous transluminal angioplasty (PTA) has become a common therapeutic standard for peripheral artery disease (PAD), high restenosis rates in the superficial femoral artery (SFA) remain a major problem. Nitinol stent implantation is reported to reduce restenosis in SFA after PTA in the general population; however, little is known about whether the nitinol stent improves primary patency after PTA in hemodialysis patients who are at higher risk of revascularization failure. The aim of this study was to clarify the effects of nitinol stent implantation for primary patency in SFA after PTA in hemodialysis patients with PAD. Eighty consecutive hemodialysis patients (167 SFA lesions) who underwent PTA with nitinol stents from January 2006 to January 2008 were compared with 64 hemodialysis patients (128 SFA lesions) who received stainless steel stents in the preceding 2 years. In the follow-up study to 2 years, incidence of restenosis, amputation, and all-cause mortality were analyzed. End points between the groups were examined with the Kaplan-Meier and log-rank methods. Prognostic values for end points were calculated by a Cox univariate analysis and Cox multivariable regression models. To statistically minimize the differences in each stent group, a propensity-matched analysis was also performed using the model including male gender, age, diabetes, hypertension, hyperlipidemia, smoking, incidence of ulcer/gangrene, and TransAtlantic Inter-Society Consensus (TASC) type C+D. The 2-year primary patency rate was 58% in the nitinol group vs 42% in the stainless steel group (hazard ratio [HR], 0.58; 95% confidence interval [CI], 0.39-0.84; P = .0045), despite a higher prevalence of TASC C+D lesion in the nitinol group (68% vs 49%, P = .0014). In 108 lesions matched after propensity score analysis, the primary patency for 2 years was 64% in the nitinol group vs 42% in the stainless steel group (HR, 0.39; 95% CI, 0.24-0.65; P = .0003). Cox multivariate models

  19. The use of a self-expandable stent with a self-expandable stent graft in a Fontan baffle.

    PubMed

    Choi, Eun Young; Lee, Kyung Suk; Song, Jin-young

    2013-02-01

    Intravascular or intracardiac stenosis occurs in various congenital heart diseases or after surgical repair. Although balloon angioplasty is the first option for relieving stenosis, frequently restenosis occurs because of elastic recoil or kingking component. The use of a self-expandable stent and covered stent in congenital heart disease has been reported for selected cases. In general, they have been performed for coarctation of the aorta or aortic aneurysm. We now report successful implantation of a self-expandable stent with a self-expandable covered stent graft in a case of lateral tunnel dehiscence with stenosis after a Fontan operation.

  20. New stents for SFA.

    PubMed

    MINAR, E; SCHILLINGER, M

    2009-10-01

    Endovascular stent implantation was introduced to femoropopliteal procedures almost two decades ago. Initial results with balloon-expandable stainless steel stents and self expanding Elgiloy stents, however, were disappointing. In particular, recurrence rates after long-segment femoropopliteal stenting were rather high, in the range of 60% to 80% at 1 year. After years of stagnation, recent developments in femoropopliteal stent technology have been promising. Self-expanding nitinol stents have been evaluated in several prospective studies. Initial problems with stent fractures seem to be resolved using second-generation devices. The second generation of Nitinol stents have an enhanced flexibility particularly also in axial direction due to a reduction of cell interconnections and a more spiral orientation of the interconnections. However, until now there is no proof of any impact of the stent design on restenosis rate. Otherwise, stenting has been shown to be beneficial compared to balloon angioplasty especially in longer femoropopliteal lesions. The superior fracture resistance of the latest stent generation in combination with the production of long nitinol stents of up to 20 cm in length allow that more difficult and complex lesions can be treated endovascularly. The main unresolved problem with femoropopliteal stenting is the treatment of instent restenosis. Future concepts to further improve long-term patency after femoropopliteal stenting are therefore under investigation, including drug-eluting stents (DES), biodegradable stents, and coated stent-grafts. Stent grafts appear to be a viable option for the treatment of complex superficial femoral artery lesions, with comparable outcomes to prosthetic above-knee femoropopliteal bypass surgery. Concerning DES, we have to wait for the results of the ongoing studies.

  1. Biodegradable and Elastomeric Poly(glycerol sebacate) as a Coating Material for Nitinol Bare Stent

    PubMed Central

    Kim, Min Ji; Hwang, Moon Young; Kim, JiHeung; Chung, Dong June

    2014-01-01

    We synthesized and evaluated biodegradable and elastomeric polyesters (poly(glycerol sebacate) (PGS)) using polycondensation between glycerol and sebacic acid to form a cross-linked network structure without using exogenous catalysts. Synthesized materials possess good mechanical properties, elasticity, and surface erosion biodegradation behavior. The tensile strength of the PGS was as high as 0.28 ± 0.004 MPa, and Young's modulus was 0.122 ± 0.0003 MPa. Elongation was as high as 237.8 ± 0.64%, and repeated elongation behavior was also observed to at least three times the original length without rupture. The water-in-air contact angles of the PGS surfaces were about 60°. We also analyzed the properties of an electrospray coating of biodegradable PGS on a nitinol stent for the purpose of enhancing long-term patency for the therapeutic treatment of varicose veins disease. The surface morphology and thickness of coating layer could be controlled by adjusting the electrospraying conditions and solution parameters. PMID:24955369

  2. Biodegradable and elastomeric poly(glycerol sebacate) as a coating material for nitinol bare stent.

    PubMed

    Kim, Min Ji; Hwang, Moon Young; Kim, JiHeung; Chung, Dong June

    2014-01-01

    We synthesized and evaluated biodegradable and elastomeric polyesters (poly(glycerol sebacate) (PGS)) using polycondensation between glycerol and sebacic acid to form a cross-linked network structure without using exogenous catalysts. Synthesized materials possess good mechanical properties, elasticity, and surface erosion biodegradation behavior. The tensile strength of the PGS was as high as 0.28 ± 0.004 MPa, and Young's modulus was 0.122 ± 0.0003 MPa. Elongation was as high as 237.8 ± 0.64%, and repeated elongation behavior was also observed to at least three times the original length without rupture. The water-in-air contact angles of the PGS surfaces were about 60°. We also analyzed the properties of an electrospray coating of biodegradable PGS on a nitinol stent for the purpose of enhancing long-term patency for the therapeutic treatment of varicose veins disease. The surface morphology and thickness of coating layer could be controlled by adjusting the electrospraying conditions and solution parameters.

  3. Self-Expandable Stent for Repairing Coarctation of the Left-Circumferential Aortic Arch with Right-sided Descending Aorta and Aberrant Right Subclavian Artery with Kommerell's Aneurysm.

    PubMed

    Khajali, Zahra; Sanati, Hamid Reza; Pouraliakbar, Hamidreza; Mohebbi, Bahram; Aeinfar, Kamran; Zolfaghari, Reza

    2017-01-01

    Endovascular treatment offers a great advantage in the management of main arteries stenoses. However, simultaneous presence of a group of anomalies may complicate the situation. Here we present a case of 21-year-old man with aortic coarctation. Radiographic imaging and angiography demonstrated aortic coarctation of the left-circumferential aortic arch, right-sided descending aorta, and Kommerell's diverticulum at the origin of right subclavian artery. These anomalies have rarely been reported to concurrently exist in the same case and the treatment is challenging. Percutaneous treatment for repair of aortic coarctation was successfully performed with deployment of self-expanding nitinol stents. Follow-up demonstrated the correction of blood pressure and improvement of the symptoms. It appears that deployment of self-expandable nitinol stents present a viable option for the management of coarcted aorta in patients having all or some of these anomalies together.

  4. Efficacy of a Dexamethasone-Eluting Nitinol Stent on the Inhibition of Pseudointimal Hyperplasia in a Transjugular Intrahepatic Portosystemic Shunt: An Experimental Study in a Swine Model

    PubMed Central

    Seo, Tae-Seok; Park, Young-Koo; Song, Ho-Young; Park, Sang Joon; Yuk, Sun-Hong

    2005-01-01

    Objective We wanted to evaluate the feasibility and efficacy of using a dexamethasone (DM)-eluting nitinol stent to inhibit the pseudointimal hyperplasia following stent placement in the transjugular intrahepatic portosystemic shunt tract (TIPS) of a swine. Materials and Methods Fifteen stents were constructed using 0.15 mm-thick nitinol wire; they were 60 mm in length and 10 mm in diameter. The metallic stents were then classified into three types; type 1 and 2 was coated with the mixture of 12% and 20%, respectively, of DM solution and polyurethane (PU), while type 3 was a bare stent that was used for control study. In fifteen swine, each type of stent was implanted in the TIPS tract of 5 swine, and each animal was sacrificed 2 weeks after TIPS creation. The proliferation of the pseudointima was evaluated both on follow-up portogram and pathologic examination. Results One TIPS case, using the type 1 stent, and two TIPS cases, using the type 2 stent, maintained their luminal patency while the others were all occluded. On the histopathologic analysis, the mean of the maximum pseudointimal hyperplasia was expressed as the percentage of the stent radius that was patent, and these values were 51.2%, 50% and 76% for the type 1, 2, and 3 stents, respectively. Conclusion The DM-eluting stent showed a tendency to reduce the development of pseudointimal hyperplasia in the TIPS tract of a swine model with induced-portal hypertension. PMID:16374082

  5. 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

  6. Nitinol Stents for Palliative Treatment of Malignant Obstructive Jaundice: Should We Stent the Sphincter of Oddi in Every Case?

    SciTech Connect

    Hatzidakis, Adam A.; Tsetis, Dimitris; Chrysou, Evangelia; Sanidas, Elias; Petrakis, John; Gourtsoyiannis, Nicholas C.

    2001-07-15

    Purpose: To evaluate the necessity of metallic stenting of the sphincter of Oddi in malignant obstructive jaundice when the tumor is more than 2 cm from the papilla of Vater.Methods: Sixty-seven self-expandable biliary stents were used in 60 patients with extrahepatic lesions of the common hepatic or common bile duct and with the distal margin of the tumor located more than 2 cm from the papilla of Vater. Stents were placed above the papilla in 30 cases (group A) and in another 30 with their distal part protruding into the duodenum (group B).Results: The 30-day mortality was 15%, due to the underlying disease. The stent occlusion rate was 17% after a mean period of 4.3 months. No major complications were noted. Average survival was 132 days for group A and 140 days for group B. In group A, 19 patients survived {<=} 90 days and in eight of these, cholangitis occurred at least once. Of 11 patients in group A with survival > 90 days, only two developed cholangitis. In group B, 13 patients who survived {<=} 90 days had no episodes of cholangitis and in 17 with survival > 90 days, cholangitis occurred in three. There is a statistically significant difference (p < 0.05) regarding the incidence of cholangitis in favor of group A.Conclusions: In patients with extrahepatic lesions more than 2 cm from the papilla and with a relative poor prognosis ({<=} 3 months), due to more advanced disease or to a worse general condition, the sphincter of Oddi should also be stented in order to reduce the postprocedural morbidity.

  7. Biliary stenting is not a prerequisite to endoscopic placement of duodenal covered self-expandable metal stents.

    PubMed

    Poincloux, L; Goutorbe, F; Rouquette, O; Mulliez, A; Goutte, M; Bommelaer, G; Abergel, A

    2016-02-01

    Duodenal covered self-expandable metal stent (cSEMS) can be used in malignant or benign gastroduodenal obstruction. The need for biliary stenting in patients with no concomitant biliary stricture, before duodenal cSEMS placement, remains unknown. The aim of this study was to determine whether cSEMS placement is responsible for biliary obstruction. This is a single-center, retrospective, case-controlled study, including 106 patients with symptomatic gastric outlet obstruction or duodenal fistula who received a covered nitinol duodenal stent by using through-the-scope/over-the-wire placement procedure. The main outcome measurement was the occurrence comparison of jaundice and bilirubin level, between patients with previous or concomitant biliary stenting (cSEMS + BS group), and patients with no biliary stent (cSEMS group) during an observational period of 90 days. Hundred and six patients underwent cSEMS placement between June 2005 and March 2014: 53 in the cSEMS group (58% male, mean age 66.4 ± 13.3 years) and 53 in cSEMS + BS group (60% male, mean age 70.4 ± 11.6 years). The obstruction was due to cancer in 45% in cSEMS group and 87% in cSEMS + BS group. No case of jaundice was reported in the cSEMS group or in the cSEMS + BS group. In cSEMS group, the mean bilirubin level (μmol/L ± SD) was 8.0 ± 4 at baseline and 8.5 ± 4.6 at day 10, while in the cSEMS + BS group it was 91.4 ± 108 at baseline and 35.3 ± 39 at day 10 (p < 0.01). Patients from the two groups were matched on age, gender and bilirubin level at baseline. Evolution of bilirubinemia was +0.98 ± 2.76 µmol/L in experimental group and +0.39 ± 522 µmol/L in the control group (p = 0.34). No significant difference was observed between the two groups in term of technical success, clinical effectiveness, migration and other complications. Previous biliary stenting is not required before endoscopic covered duodenal stent placement in patients with no associated biliary obstruction. Prospective studies

  8. Expandable stents: unique devices and clinical uses.

    PubMed

    Ross, Andrew S; Kozarek, Richard A

    2011-07-01

    The use of stents throughout the gastrointestinal tract has evolved over the past century. The evolution of endoscopic ultrasound and significant improvements in stent design are key factors that have allowed endoscopists to drive the use of stents in gastroenterology into new directions. Endoscopic creativity remains crucial in the evolution of any new endoscopic technology. Finally, the use of multidisciplinary teams, including endoscopists, radiologists, and surgeons, allows for the exchange of ideas and procedural planning necessary for successful innovation.

  9. [Placement of an ultraflex nitinol stent for severe tracheobronchial obstruction in a case of relapsing polychondritis].

    PubMed

    Miyazaki, Hiroo; Shimane, Shoko; Morita, Sumihito; Yamada, Takashi; Ida, Masaaki; Ozawa, Yoshihiro; Nagayama, Masaharu; Iwakiri, Shotaro; Chihara, Koji; Hirata, Takeo

    2005-05-01

    A 59-year-old man, who had been treated for bronchial asthma since 2000, was hospitalized with high fever and productive cough in November 2003. Chest radiography on admission showed consolidations in both lower lung fields, and computed tomography demonstrated anteroposterior narrowing of both main bronchi. A physical examination revealed deformity of auricular cartilage and saddle nose, and we diagnosed him relapsing polychondritis (RP). When he was readmitted 4 months later because of severe tracheobronchial stenosis and respiratory failure he required mechanical ventilation, but it was difficult to wean him from the ventilator. Self-expandable metallic stents were placed in the left main bronchus and the trachea. After the procedure, he was successfully weared from mechanical ventilation. Since airway complications of RP can be fatal, stent implantation should be considered in the management of RP with airway manifestations.

  10. Prophylactic placement of a covered nitinol stent to prevent carotid blowout in a patient with supraclavicular lymph node metastasis from esophageal cancer.

    PubMed

    Fujita, Takeshi; Ito, Katsuyoshi; Tanabe, Masahiro; Matsunaga, Naofumi

    2015-01-01

    Enlargement of primary tumor and metastatic lymph nodes in patients with head and neck cancer can be progressive and invade the surrounding vessels despite intensive treatment. Carotid blowout (CBS) tends to occur in these patients, and prompt treatment is required. Surgical management of carotid blowout is technically troublesome because exploration and repair of the previously irradiated or tumor-invaded field are difficult. Endovascular therapy with stent deployment is a good alternative to surgery. Even with such interventional procedures as stent grafting, it is sometimes difficult to obtain favorable outcomes in end-stage patients with poor general conditions. The prophylactic placement of a covered nitinol stent was performed to prevent carotid blowout in a patient with supraclavicular lymph node metastasis from esophageal cancer, and fatal bleeding due to carotid blowout was avoided. The usefulness of the prophylactic placement of a covered nitinol stent for preventing carotid blowout in an end-stage patient is presented.

  11. First in human experience of a new self-expandable percutaneous pulmonary valve implantation using knitted nitinol-wire and tri-leaflet porcine pericardial valve in the native right ventricular outflow tract.

    PubMed

    Kim, Gi Beom; Kwon, Bo Sang; Lim, Hong Gook

    2017-04-01

    Balloon-expandable percutaneous pulmonary valve systems using the Melody and Edwards SAPIEN transcatheter heart valves have been increasingly used instead of surgically implantable pulmonary valves. However, limited patients with right ventricular outflow tract (RVOT) lesions are suitable candidates for percutaneous pulmonary valve implantation (PPVI) using these systems after surgical correction of tetralogy of Fallot. Therefore, larger self-expandable valved-stents are being developed for native RVOT lesions. We report the first-in-human case of a new self-expandable PPVI in a patient with a native RVOT lesion using a newly made knitted nitinol-wire stent mounted with a tri-leaflet porcine pericardial valve developed in South Korea. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

  12. Use of self-expanding stents for better intracranial flow diverter wall apposition.

    PubMed

    Kühn, Anna Luisa; Wakhloo, Ajay K; Gounis, Matthew J; Kan, Peter; de Macedo Rodrigues, Katyucia; Lozano, J Diego; Marosfoi, Miklos G; Perras, Mary; Brooks, Christopher; Howk, Mary C; Rex, David E; Massari, Francesco; Puri, Ajit S

    2017-04-01

    Background Flow diverter (FD) malapposition is associated with stroke-related complications. We document the use of self-expanding nitinol stents to remove/reduce the ledge of a FD deployed for aneurysm treatment. Methods We identified five patients who were treated with the Pipeline embolization device (PED) in conjunction with a Neuroform EZ stent for inadequate wall apposition of the ends of the FD at our institution between May 2014 and July 2015. Among other parameters, angiographic results, cone-beam computed tomography assessment of wall apposition and patient clinical outcome were evaluated. Results Incomplete device end apposition was seen in three cases, and precarious positioning of the distal end of the PED over the aneurysm neck was seen in two cases. In all five cases, successful treatment with good wall apposition and proper pinning of the PED distal edge was achieved using an additional Neuroform EZ stent. Appropriate aneurysm neck coverage and flow stagnation was seen in all cases. The combination of high radial outward force and open-cell design permits the Neuroform EZ stent to jail the malappositioned edges of the FD while maintaining good vessel-wall apposition itself and prevent migration of the PED. Short-term follow-up angiography showed device patency and complete aneurysm obliteration in all cases. Conclusions Preliminary results of this small case series suggest that the Neuroform EZ stent allows for effective treatment of FD malapposition in selected patients amenable for this endovascular approach. Long-term and larger cohort studies are needed to validate these results.

  13. Numerical Modeling of Nitinol Stent Oversizing in Arteries with Clinically Relevant Levels of Peripheral Arterial Disease: The Influence of Plaque Type on the Outcomes of Endovascular Therapy.

    PubMed

    Gökgöl, Can; Diehm, Nicolas; Büchler, Philippe

    2017-02-01

    Oversizing of the Nitinol stents in the femoro-popliteal arterial tract is commonly performed by clinicians and further encouraged by stent manufacturers. However, in spite of the procedure's supposed benefits of strong wall apposition and increased luminal gain, its effects on the mechanical behavior of arteries with peripheral arterial disease are not fully clear. In this study, finite element (FE) analyses of endovascular revascularization of an idealized artery with 70% stenosis and three different plaque types have been performed to examine the influence of Nitinol stent oversizing on the arterial stresses and acute lumen gain. The analyses included the simulation of balloon angioplasty to model plaque failure, followed by stent implantation, in which four different oversizing ratios were investigated. Results showed that balloon angioplasty was crucial in determining the stress levels of the artery prior to stent implantation and heavily affected the outcome of endovascular therapy. For all plaque types, Nitinol stent oversizing was found to produce a marginal lumen gain in contrast to a significant increase in arterial stresses. For the arteries with lightly and moderately calcified plaques, oversizing was found to be non-critical; whereas for the arteries with heavily calcified plaques, the procedure should be avoided due to a risk of tissue failure.

  14. Safety and efficacy metrics for primary nitinol stenting in femoropopliteal occlusive disease: a meta-analysis and critical examination of current methodologies.

    PubMed

    Vardi, Moshe; Novack, Victor; Pencina, Michael J; Doros, Gheorghe; Burke, David A; Elmariah, Sammy; Cutlip, Donald E; Mauri, Laura; Yeh, Robert W

    2014-05-01

    The efficacy and safety of primary stenting for superficial femoral artery (SFA) disease have been benchmarked against historically derived performance goals. However, contemporary evidence evaluating SFA stenting is accumulating. The objective of this systematic review and meta-analysis was to quantitatively assess outcomes after primary SFA stenting with nitinol stents in contemporary practice, to compare these rates with commonly used efficacy and safety goals, and to discuss the clinical and regulatory implications of these findings. We searched MEDLINE, the US Food and Drug Administration (FDA) website, reference lists of qualifying articles, and conference proceedings until October 2012. Studies prospectively assessing primary nitinol stenting for diseased SFA were sought. Data from 11 prospective clinical trials were included. The twelve-month primary patency (PP) rate was reported in five trials. The meta-analytic 12-month PP rate was 71.6% (95% confidence interval [CI] 66.4-76.7%). The meta-analytic rate of 30-day freedom from a composite of death, target limb amputation, and reintervention was 99.9% (95% CI 100.0-90.0%). Contemporary nitinol-based bare-metal stents performed well in controlled settings. Occurrence of the 1-month composite safety endpoint was extremely uncommon. Copyright © 2013 Wiley Periodicals, Inc.

  15. Self-expandable biodegradable biliary stents in porcine model.

    PubMed

    Grolich, Tomáš; Crha, Michal; Novotný, Ladislav; Kala, Zdeněk; Hep, Aleš; Nečas, Alois; Hlavsa, Jan; Mitáš, Ladislav; Misík, Jan

    2015-02-01

    Treatment or prevention of a benign biliary tree stricture is an unresolved problem. A novel self-expandable biodegradable polydioxanon biliary stent in a porcine model was studied. This new stent was used in 23 pigs. Feasibility and safety of surgical stenting, time of biodegradation, and histologic reaction in 2, 8, 13, and 20 wk of a follow-up were studied. All stents were inserted into a common bile duct through a duodenal papilla following small dilatation. After surgical evaluation of abdominal cavities, the pigs were sacrificed to remove common bile ducts with the stents. All bile ducts were assessed by macroscopic and histopathologic examination. Self-expansion was correct in all cases. Neither bile duct obstruction nor postsurgical complications were observed. Macroscopic evaluation indicated lightening of the stent color in 2 wk, a partial disintegration in 8 wk, and a complete absorption in 13 and 20 wk. Histologic evaluation in general substantiated a mild-to-moderate inflammatory reaction in the lamina propria during the whole follow up and had no clinical consequences. No cholangitis, necrosis, abscess, or excessive fibroplasia was found in a hepatoduodenal ligament. Our results suggest that polydioxanon biodegradable self-expanding stents seem to be useful for biliary system implantation, offer a good biocompatibility, and completely degrade within 13 wk. Copyright © 2015 Elsevier Inc. All rights reserved.

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

    PubMed

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

    2015-06-01

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

  17. MR safety and imaging of neuroform stents at 3T.

    PubMed

    Nehra, Arvind; Moran, Christopher J; Cross, Dewitte T; Derdeyn, Colin P

    2004-10-01

    The Neuroform stent is a self-expanding nitinol stent designed for use in wide-necked intracranial aneurysms. Heating and imaging artifacts were evaluated by using a porcine carotid artery aneurysm model in a 3T MR system. A suspended Neuroform stent was tested for deflection. No heating was measured, and no evidence of deflection of the stent was found. Imaging artifacts were minimal. MR imaging in patients with Neuroform stent-treated aneurysms is safe and feasible.

  18. Balloon-expandable covered stent therapy of complex endovascular pathology.

    PubMed

    Giles, Heath; Lesar, Christopher; Erdoes, Luke; Sprouse, Richard; Myers, Stuart

    2008-11-01

    The current study was designed to investigate our hypotheses that balloon-expandable covered stents display acceptable function over longitudinal follow-up in patients with complex vascular pathology and provide a suitable alternative for the treatment of recurrent in-stent restenosis. All stents were Atrium iCast, which is a balloon-mounted, polytetrafluoroethylene-covered stent with a 6F/7F delivery system. A retrospective review was performed of 49 patients with 66 stented lesions. Data were analyzed with life tables and t-tests. The most commonly treated vessels were the iliac (61%) and renal (24%) arteries. Indications for covered stent placement were unstable atheromatous lesions (50%), recurrent in-stent restenosis (24%), aneurysm (8%), aortic bifurcation reconstruction (7.5%), dissection (4.5%), endovascular aneurysm repair-related (4.5%), and stent fracture (1.5%). Patency was assessed by angiogram or duplex ultrasonography. The primary end point was patency and secondary end points were technical success and access-site complications. Mean follow-up was 13 months (range 1.5-25). The technical success rate was 97%. Unsuccessful outcomes were due to deployment error (n=1) and stent malpositioning (n=1). The cohort (n=64) 6- and 12-month primary patency rates were 96% and 84%, respectively. Twelve-month assisted primary patency was 98%. Iliac artery stents (n=38) had a primary patency of 97% at 6 months and 84% at 12 months with an assisted primary patency of 100% at 12 months. Renal artery stents (n=16) had a primary patency of 92% at 6 months and 72% at 12 months with an assisted primary patency of 92% at 6 and 12 months. Stents placed for recurrent in-stent restenosis (n=16) had a primary patency of 85%, assisted primary patency of 93%, and a 15% restenosis rate at 12 months. Specifically, stents placed for renal artery recurrent in-stent restenosis (n=10) had a primary patency of 73%, assisted primary patency of 82%, and a restenosis rate of 27%. The

  19. In vitro comparison of self-expanding versus balloon-expandable stents in a human ex vivo model.

    PubMed

    Grenacher, Lars; Rohde, Stefan; Gänger, Ellen; Deutsch, Jochen; Kauffmann, Günter W; Richter, Götz M

    2006-01-01

    The objective was to compare the radial strength and expansile precision of self-expanding stents and balloon-expandable stents in a human cadaver bifurcation model. Seven different self-expanding (LUMINEXX, JOSTENT SelfX, JOSTENT SelfX hrf, Sinus-Repo, Sinus SuperFlex, Easy Wallstent, SMART) and four different balloon-expandable stent models (Palmaz, Sinus Stent, SAXX Medium, JOSTENT peripheral), each type 10 stents (total n = 110 stents) were implanted into the common iliac arteries of human cadaver corpses. The maximum stent diameter was 10 mm for all models. After stent implantation, the specimens were filled with silicone caoutchouc. After 24 h, the vascular walls including the stents were removed from the hardened casts. Diameters were taken and the weight of the cast cylinders was measured in air and in purified water to calculate the volume of the bodies (according to Archimedes Law) as a relative but precise degree for the radial strength of the implanted stents. The cylindrical casts of the self-expanding stents showed lower mean diameters (8.2 +/- 1.0 mm) and mean volumes (0.60 +/- 0.14 ml/cm) than in the balloon-expandable stent group (10.1 +/- 0.3 mm and 0.71 +/- 0.04 ml/cm, respectively; p < 0.01). The nominal maximum diameter of 10 mm was not achieved in any of the self-expanding stents, but this was achieved in more than 70% (29/40) of the balloon-expandable stent specimens (p < 0.05). The variation between achieved volumes was significantly larger in self-expanding (range: 0.23-0.78 ml/cm) than in balloon-expandable stents (range: 0.66-0.81 ml/cm; p < 0.05). Self-expanding stents presented considerably lower radial expansion force and lower degree of precision than balloon-expandable stents.

  20. In Vitro Comparison of Self-Expanding Versus Balloon-Expandable Stents in a Human Ex Vivo Model

    SciTech Connect

    Grenacher, Lars Rohde, Stefan Gaenger, Ellen; Deutsch, Jochen; Kauffmann, Guenter W.; Richter, Goetz M.

    2006-04-15

    The objective was to compare the radial strength and expansile precision of self-expanding stents and balloon-expandable stents in a human cadaver bifurcation model. Seven different self-expanding (LUMINEXX, JOSTENT SelfX, JOSTENT SelfX hrf, Sinus-Repo, Sinus SuperFlex, Easy Wallstent, SMART) and four different balloon-expandable stent models (Palmaz, Sinus Stent, SAXX Medium, JOSTENT peripheral), each type 10 stents (total n = 110 stents) were implanted into the common iliac arteries of human cadaver corpses. The maximum stent diameter was 10 mm for all models. After stent implantation, the specimens were filled with silicone caoutchouc. After 24 h, the vascular walls including the stents were removed from the hardened casts. Diameters were taken and the weight of the cast cylinders was measured in air and in purified water to calculate the volume of the bodies (according to Archimedes Law) as a relative but precise degree for the radial strength of the implanted stents. The cylindrical casts of the self-expanding stents showed lower mean diameters (8.2 {+-} 1.0 mm) and mean volumes (0.60 {+-} 0.14 ml/cm) than in the balloon-expandable stent group (10.1 {+-} 0.3 mm and 0.71 {+-} 0.04 ml/cm, respectively; p < 0.01). The nominal maximum diameter of 10 mm was not achieved in any of the self-expanding stents, but this was achieved in more than 70% (29/40) of the balloon-expandable stent specimens (p < 0.05). The variation between achieved volumes was significantly larger in self-expanding (range: 0.23-0.78 ml/cm) than in balloon-expandable stents (range: 0.66-0.81 ml/cm; p < 0.05). Self-expanding stents presented considerably lower radial expansion force and lower degree of precision than balloon-expandable stents.

  1. Expandable bioresorbable endovascular stent. I. Fabrication and properties.

    PubMed

    Su, Shih-Horng; Chao, Robert Y N; Landau, Charles L; Nelson, Kevin D; Timmons, Richard B; Meidell, Robert S; Eberhart, Robert C

    2003-06-01

    A bioresorbable, expandable poly(L-lactic acid) stent has been designed, based on a linear, continuous coil array principle, by which multiple furled lobes convert to a single lobe upon balloon expansion, without heating. Stent strength and compliance are sufficient to permit deployment by a conventional balloon angioplasty catheter. Several multiple lobe configurations were investigated, with expansion ratios ranging from 1.4 to 1.9 and expanded diameters ranging from 2.3 to 4.7 mm. Compression resistance of the expanded stent is dependent on fiber coil density and fiber ply. A range sufficient for endovascular service was obtained, with less than 4% elastic recoil in six day saline incubation studies. Surface plasma treatment with di(ethylene glycol) vinyl ether significantly reduced platelet adhesion in a 1 h porcine arteriovenous shunt model. Patency was maintained in one week implant studies in the porcine common femoral artery. However, a strong inflammatory response, and significant reduction of the vascular lumen were observed following two weeks implantation. The design principles and fabrication techniques for this bioresorbable stent are sufficiently versatile that a broad range of applications can be addressed. Much work remains to be done, including long-term evaluation of the inflammatory response, and of polymer degradation. The results of this study demonstrate the feasibility of expandable biodegradable stent design and deployment by conventional means.

  2. Use of a Nitinol Wire Stent for Management of Severe Tracheal Stenosis in an Eclectus Parrot (Eclectus roratus).

    PubMed

    Mejia-Fava, Johanna; Holmes, Shannon P; Radlinsky, MaryAnn; Johnson, Dan; Ellis, Angela E; Mayer, Jörg; Schnellbacher, Rodney; Divers, Stephen J

    2015-09-01

    A 25-year-old, female eclectus parrot (Eclectus roratus) presented for dyspnea 3 weeks after anesthesia and surgery for egg yolk coelomitis. Radiography, computed tomography, and tracheoscopy revealed multiple tracheal strictures spanning a length of 2.6 cm in the mid to distal trachea. Histopathologic examination revealed mild fibrosis, inflammation, and hyperplasia consistent with acquired tracheal strictures. Tracheal resection was not considered possible because of the length of the affected trachea. The strictures were resected endoscopically, and repeated balloon dilation under fluoroscopic guidance over the course of 10 months resulted in immediate but unsustained improvement. Computed tomography was used to measure the stenotic area. A 4 × 36-mm, custom-made, nitinol wire stent was inserted into the trachea under fluoroscopic guidance. After stent placement, intermittent episodes of mild to moderate dyspnea continued, and these responded to nebulization with a combination of saline, acetylcysteine, and dexamethasone. Multiple attempts to wean the patient off nebulization therapy and to switch to a corticosteroid-free combination were unsuccessful. The parrot eventually developed complications, was euthanatized, and necropsy was performed. Histologically, the tracheal mucosa had widespread erosion to ulceration, with accumulation of intraluminal exudate and bacteria, severe degeneration of skeletal muscle and tracheal rings, prominent fibrosis, and mild to moderate, submucosal inflammation. Clinicopathologic findings in this case suggested tracheomalacia, which has not been previously described in birds. Custom-made tracheal stents can be used for severe tracheal stenosis in birds when tracheal resection and anastomosis is not possible. Complications of tracheal stent placement in birds may include tracheitis and tracheomalacia. To our knowledge, this is the first report of tracheal stent placement in an avian species.

  3. Stent Fracture and Reocclusion After Placement of a Single Self-Expanding Stent in the Common Iliac Artery and Endovascular Treatment

    SciTech Connect

    Higashiura, Wataru Sakaguchi, Shoji; Morimoto, Kengo; Kichikawa, Kimihiko

    2008-09-15

    We present a case of fracture of a single self-expanding stent placed in the common iliac artery (CIA). An 80-year-old woman underwent placement of a self-expanding stent for CIA occlusion. Stent fracture and reocclusion were detected after 18 months. Successful revascularization was achieved using a stent-in-stent maneuver. The possibility of stent fracture with reocclusion should be considered following treatment with a single self-expanding stent for CIA occlusion.

  4. 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.

  5. Simulations of Self-Expanding Braided Stent Using Macroscopic Model of NiTi Shape Memory Alloys Covering R-Phase

    NASA Astrophysics Data System (ADS)

    Frost, M.; Sedlák, P.; Kruisová, A.; Landa, M.

    2014-07-01

    Self-expanding stents or stentgrafts made from Nitinol superelastic alloy are widely used for a less invasive treatment of disease-induced localized flow constriction in the cardiovascular system. The therapy is based on insertion of a stent into a blood vessel to maintain the inner diameter of the vessel; it provides highly effective results at minimal cost and with reduced hospital stays. However, since stent is an external mechanical healing tool implemented into human body for quite a long time, information on the mechanical performance of it is of fundamental importance with respect to patient's safety and comfort. Advantageously, computational structural analysis can provide valuable information on the response of the product in an environment where in vivo experimentation is extremely expensive or impossible. With this motivation, a numerical model of a particular braided self-expanding stent was developed. As a reasonable approximation substantially reducing computational demands, the stent was considered to be composed of a set of helical springs with specific constrains reflecting geometry of the structure. An advanced constitutive model for NiTi-based shape memory alloys including R-phase transition was employed in analysis. Comparison to measurements shows a very good match between the numerical solution and experimental results. Relation between diameter of the stent and uniform radial pressure on its surface is estimated. Information about internal phase and stress state of the material during compression loading provided by the model is used to estimate fatigue properties of the stent during cyclic loading.

  6. 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.

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

    SciTech Connect

    Lee, S; Li, Z; Jalaj, S; McGaw, C; B K, John; J S, Scolapio; J C, Munoz

    2014-06-01

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

  8. Comparison of Self-Expanding Polyethylene Terephthalate and Metallic Stents Implanted in Porcine Iliac Arteries

    SciTech Connect

    Wilczek, Krzysztof; Scheerder, Ivan de; Wang Kai; Verbeken, Eric; Piessens, Jan

    1996-05-15

    Purpose: Comparison of the biocompatibility of self-expanding polyethylene terephthalate (PET) stents with self-expanding metallic stents (Wallstents). Methods: Diameter- and length-matched PET stents and Wallstents were symmetrically implanted in the paired iliac arteries of 13 crossbred domestic swine. Stent deployment was studied angiographically and with intravascular ultrasound immediately after stent implantation. The angiographic stented lumen diameter was measured using quantitative vessel analysis before, immediately after stenting, and at 6-week follow-up. Cross-section histopathology and area morphometry were performed. Results: Immediately poststenting, intravascular ultrasound revealed proximal dislocation of 5 of the 13 PET stents, whereas all metal stents were firmly embedded at the implantation site. At 6-week follow-up, three of the remaining PET stents were totally or subtotally occluded by organized thrombus, whereas all metal stents were patent. Compared with immediately poststenting, the angiographic lumen diameter within the five remaining PET stents was reduced by 30%, and that of the metallic stents was virtually unaltered (p < 0.02). This observation was confirmed by postmortem morphometry, wherein the PET-stented vessel segments a diameter stenosis of 40% was measured vs only 9% in the metallic stents (p < 0.0001). Conclusion: PET-stent deployment is difficult to control due to the lack of radiopacity of this stent. PET stents seem to be more thrombogenic and lead to significantly more neointimal proliferation than metallic stents.

  9. Initial Outcomes of Symmetrically Flared Covered Nitinol Stents for Esophageal Pathologies.

    PubMed

    Yaffee, David W; Solomon, Brian; Xia, Yu; Grossi, Eugene A; Zervos, Michael D; Bizekis, Costas S

    2015-10-01

    A recently available, low profile, fully covered metal stent with symmetrical flares (FCMSF) may offer improved resistance to migration in esophageal disease. A retrospective review of 58 esophageal FCMSF placed in 46 consecutive patients was performed. Pathologies included stricture and leak of benign and malignant etiology. Sixteen of 58 stents (28%) were placed urgently/emergently. All patients had successful stent deployment with 0% stent-related hospital mortality. Postoperative morbidity occurred in 15 of the 58 (26%) stents and included stent migration, atrial fibrillation, pneumonia, pneumothorax, urinary retention, hemodynamic instability, and chronic obstructive pulmonary disease exacerbation. In patients with stricture (n=29), mean dysphagia scores were reduced from 3.1±0.6 preoperatively to 1.1±0.8 postoperatively (P<0.001). For leak, stent therapy (±drainage) avoided formal esophageal operation in 95% (21/22). Four stents (6.9%) were removed for stent migration, 2 of which migrated after adjuvant chemoradiation. Adjuvant chemoradiation therapy was an independent risk factor for stent migration (odds ratio=1.6; P=0.02) by multivariable regression analysis. The mean duration of stent therapy was 65±62 days for stricture (27/34 remain in situ) and 57±57 days for leak (10/22 remain in situ). The median hospital length of stay was 2 days. FCMSF provide a safe and effective therapy for both benign and malignant esophageal dysphagia and leaks. The symmetrical property may contribute to the overall low observed migration rate while still allowing for simple and safe stent retrieval.

  10. [Results of the upper digestive tract stenting with self-expanding stents].

    PubMed

    Fedorov, A G; Davydova, S V; Klimov, A E; Lebedev, N V

    2013-01-01

    The work is based on the analysis of the palliative treatment of 66 patients with malignant upper digestive tract obstruction who underwent implantation of 75 self-expanding metallic stents in the period of 2003-2012 yy. Early postoperative complications developed in 10 (15.2%) cases. Procedure-related complications were observed in 8 (12.1%) patients, non-specific complications occurred in 2 (3.0%) patients. In-hospital lethality was 4.5% (3 patients). 51 patients were followed until death. Symptomatic relapse of obstruction was observed in 4 cases. Median survival was 97 days. Stenting with self-expanding metal stents was concluded to be an effective and safe method of palliation of malignant upper digestive tract stenosis.

  11. Comparison of Small Intestinal Submucosa-Covered and Noncovered Nitinol Stents with PTFE Endografts in Injured Ovine Femoral Arteries: A Pilot Study

    SciTech Connect

    Nakata, Manabu; Pavcnik, Dusan Uchida, Barry T.; Van Alstine, William; Timmermans, Hans A.; Toyota, Naoyuki; Terada, Masaki; Brountzos, Elias; Kaufman, John A.; Keller, Frederick S.; Rosch, Josef

    2003-09-15

    The purpose of this study was to compare performance of small intestinal submucosa (SIS)-covered endografts (SCEs) to polytetra-fluoroethylene (PTFE)-covered endografts (PCEs) and to bare nitinol stents (BSs) in injured sheep femoral artery (FA). Bare Zilver 6 mm x 40 mm nitinol stents (n = 6), Zilver stents covered with SIS (n = 6), and Palmaz stents 6 mm x 37 mm covered with PTFE (n = 6) were implanted in the balloon-injured FAs of nine female sheep. Follow-up arteriograms were obtained before animal sacrifice at 1, 3 and 6 months, with three animals at each time point. The FAs with the implanted device were explanted for histologic studies and morphologic measurements. Stent implantation was technically successful in all sheep. All BS and SCEs were patent at each time point. Five BSs and five SCEs exhibited formation of progressive eccentric intimal hyperplasia (IH) that was more advanced in SCE at 6 months. Cross-sectional area narrowing averaged 60% for BSs and 67% for SCEs. One BS, one SCE and two patent PCEs exhibited mild-to-moderate formation of concentric IH. Four PCS occluded one at 1 month, two at 3 months and one at 6 months. Performance of the devices placed into sheep FAs depended on their relation to the curving peri-articular portion of the FA during extremity flexion. BSs and SCEs placed in this portion exhibited progressive growth of eccentric IH while PCEs placed in this portion occluded.

  12. Comparison of small intestinal submucosa-covered and noncovered nitinol stents with PTFE endografts in injured ovine femoral arteries: a pilot study.

    PubMed

    Nakata, Manabu; Pavcnik, Dusan; Uchida, Barry T; VanAlstine, William; Timmermans, Hans A; Toyota, Naoyuki; Terada, Masaki; Brountzos, Elias; Kaufman, John A; Keller, Frederick S; Rosch, Josef

    2003-01-01

    The purpose of this study was to compare performance of small intestinal submucosa (SIS)-covered endografts (SCEs) to polytetra-fluoroethylene (PTFE)-covered endografts (PCEs) and to bare nitinol stents (BSs) in injured sheep femoral artery (FA). Bare Zilver 6 mm X 40 mm nitinol stents (n = 6), Zilver stents covered with SIS (n = 6), and Palmaz stents 6 mm x 37 mm covered with PTFE (n = 6) were implanted in the balloon-injured FAs of nine female sheep. Follow-up arteriograms were obtained before animal sacrifice at 1, 3 and 6 months, with three animals at each time point. The FAs with the implanted device were explanted for histologic studies and morphologic measurements. Stent implantation was technically successful in all sheep. All BS and SCEs were patent at each time point. Five BSs and five SCEs exhibited formation of progressive eccentric intimal hyperplasia (IH) that was more advanced in SCE at 6 months. Cross-sectional area narrowing averaged 60% for BSs and 67% for SCEs. One BS, one SCE and two patent PCEs exhibited mild-to-moderate formation of concentric IH. Four PCS occluded one at 1 month, two at 3 months and one at 6 months. Performance of the devices placed into sheep FAs depended on their relation to the curving peri-articular portion of the FA during extremity flexion. BSs and SCEs placed in this portion exhibited progressive growth of eccentric IH while PCEs placed in this portion occluded.

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

    SciTech Connect

    Mermuys, Koen; Maleux, Geert Heye, Sam; Lombaerts, Rita; Nevens, Frederik

    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 until 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.

  14. Self-expandable metallic stents in nonmalignant large airway disease.

    PubMed

    Fortin, Marc; MacEachern, Paul; Hergott, Christopher A; Chee, Alex; Dumoulin, Elaine; Tremblay, Alain

    2015-01-01

    Airway self-expandable metallic stents (SEMS) were initially studied in malignant airway obstruction; however, their use in benign airway diseases has become progressively more frequent. This may be explained by their ease of insertion compared with silicone stents, which require rigid bronchoscopy for insertion. While initial experience with SEMS in benign disease suggested efficacy and promising short-term safety profile, long-term follow-up revealed significant complication rates. In addition to a high complication rate, the management of these complications is made more difficult by the semipermanent nature of these devices. Reported complications include infection, granulation tissue formation, stent migration, stent fracture, airway perforation and fistula formation, as well as extension of the initial injury, potentially eliminating other therapeutic options such as surgical resection. Therefore, SEMS should only be used in nonmalignant large airway disease as a last resort for patients in whom other endoscopic methods, including silicone stents and dilations, as well as surgical options have failed or are technically not feasible.

  15. Use of a New Hybrid Heparin-Bonded Nitinol Ring Stent in the Popliteal Artery: Procedural and Mid-term Clinical and Anatomical Outcomes.

    PubMed

    Parthipun, Aneeta; Diamantopoulos, Athanasios; Kitrou, Panagiotis; Padayachee, Soundrie; Karunanithy, Narayan; Ahmed, Irfan; Zayed, Hany; Katsanos, Konstantinos

    2015-08-01

    To report the immediate and mid-term clinical and anatomical outcomes of a novel, hybrid, heparin-bonded, nitinol ring stent (TIGRIS; Gore Medical) when used for the treatment of lesions located in the popliteal artery. This was a prospective single-centre registry. Patients eligible for inclusion were individuals suffering from symptomatic popliteal arterial occlusive disease (Rutherford-Becker stage 3-6; P1-P3 segments) and treated with placement of the TIGRIS stent(s). Patients were prospectively scheduled for clinical review and duplex ultrasound follow-up after 6 and 12 months. Outcome measures included immediate technical success, primary vessel patency, in-stent binary restenosis (evaluable by Duplex at 50 % threshold; PSVR > 2.0), freedom from target lesion revascularization (TLR) and amputation-free survival (AFS) estimated by Kaplan-Meier (K-M) survival analysis. Cox proportional-hazards regression analysis was also performed to adjust for confounders and search for independent predictors of outcomes. From August 2012 to March 2014, a total of 54 popliteal TIGRIS stents were implanted in 50 limbs of 48 patients (27 men and 21 women; mean age 76.0 ± 1.7 years). Median Rutherford-Becker stage was five at baseline and 37/50 (74.0%) were chronic total occlusions. Technical success was achieved in all cases (100%). Stented lesion length was 114.2 ± 36.9 mm (range 6-20 cm). Median follow-up was 11.8 ± 0.8 months. After 12 months, primary patency of the TIGRIS stent was 69.5 ± 10.2% with an 86.1 ± 5.9% freedom from TLR and 87 ± 5.0% AFS (K-M estimates). The TIGRIS hybrid heparin-bonded nitinol ring stent is a safe and effective endovascular option for complex occlusive disease of the popliteal artery.

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

    PubMed

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

    2016-02-14

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

  17. Primary Stent Placement for Recanalization of Iliac Artery Occlusions: Using a Self-Expanding Spiral Stent

    SciTech Connect

    Kim, Jae-Kyu; Kim, Yun-Hyeon; Chung, Sang-Yeung; Kang, Heoung-Keun

    1999-07-15

    Purpose: To report the clinical results for recanalizations of an occluded iliac artery by a self-expanding spiral stent. Methods: We attempted to recanalize 36 iliac artery occlusions in 34 patients [33 men, 1 woman, aged 51-75 years (average 61.6 years)]. The average lesion length was 6.92 cm (range 1-14 cm). The patients' chief complaints were intermittent claudication and resting pain. Fontaine classification was assigned before and after the procedure. Technical and clinical success were also analyzed. Results: Forty-five stents were successfully deployed in 34 patients. All 36 lesions (13 in the external iliac artery, 12 in the common iliac artery, and 11 in both) were patently recanalized on angiography. The follow-up period ranged from 6 months to 36 months (mean 11.9 months). Fourteen stents (39%) with incomplete expansion were dilated with a balloon catheter. Good technical (100%) and clinical (94%) results were obtained. The only complication was one hematoma at the puncture site. Reocclusions were noted in two lesions (5%) at 1 week and 15 months, respectively. Conclusion: A self-expanding spiral stent is a safe and effective device for recanalization of an iliac artery occlusion as the primary stent without any previous intervention.

  18. Mechanical Characteristics of Composite Knitted Stents

    SciTech Connect

    Tokuda, Takanori Shomura, Yuzo; Tanigawa, Noboru; Kariya, Shuji; Komemushi, Atsushi; Kojima, Hiroyuki; Sawada, Satoshi

    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 using 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, causing

  19. Clinical impact and risk stratification of balloon angioplasty for femoropopliteal disease in nitinol stenting era: Retrospective multicenter study using propensity score matching analysis.

    PubMed

    Tsuchiya, Taketsugu; Takamura, Takaaki; Soga, Yoshimitsu; Iida, Osamu; Hirano, Keisuke; Suzuki, Kenji; Yamaoka, Terutoshi; Miyashita, Yusuke; Kitayama, Michihiko; Kajinami, Koji

    2016-01-01

    Nitinol stenting could bring the better outcome in endovascular therapy for femoropopliteal disease. However, it might be expected that recent marked advances in both device technology and operator technique had led to improved efficacy of balloon angioplasty even in this segment. The aims of this study were to evaluate the clinical impact of balloon angioplasty for femoropopliteal disease and make risk stratification clear by propensity score matching analysis. Based on the multicenter retrospective data, 2758 patients (balloon angioplasty: 729 patients and nitinol stenting: 2029 patients), those who underwent endovascular therapy for femoropopliteal disease, were analyzed. The propensity score matching procedure extracted a total of 572 cases per group, and the primary patency rate of balloon angioplasty and nitinol stenting groups after matching was significantly the same (77.2% vs 82.7% at 1 year; 62.2% vs 64.3% at 3 years; 47.8% vs 54.3% at 5 years). In multivariate Cox hazard regression analysis, significant predictors for primary patency were diabetes mellitus, regular dialysis, cilostazol use, chronic total occlusion, and intra-vascular ultra-sonography use. The strategy of balloon angioplasty was not evaluated as a significant predictor for the primary patency. After risk stratification using five items (diabetes mellitus, regular dialysis, no use of intra-vascular ultra-sonography, chronic total occlusion, and no use of cilostazol: the DDICC score), the estimated primary patency rates of each group (low, DDICC score 0-2; moderate, DDICC score 3; high risk, DDICC score 4-5) were 88.6%, 78.3%, and 63.5% at 1 year; 75.2%, 60.7%, and 39.8% at 3 years; and 66.0%, 47.1%, and 26.3% at 5 years (p < 0.0001). The primary patency rate of balloon angioplasty and nitinol stenting groups was significantly the same in each risk stratification. This study suggests that balloon angioplasty does not have inferiority to nitinol stenting but does have

  20. Superficial femoral artery nitinol stent in a patient with nickel allergy.

    PubMed

    Jetty, Prasad; Jayaram, Srinidhi; Veinot, John; Pratt, Melanie

    2013-11-01

    We present a case of a patient who developed a systemic allergic reaction following placement of a nitnol stent in the superficial femoral artery for claudication symptoms. Shortly after, he was tested for contact dermatitis and found to have a severe reaction to nickel. His symptoms of severe itch and generalized rash resolved within days following stent explantation and reconstruction with a vein graft. The epidemiology and clinical significance of nickel allergy and the concomitant use of nickel-alloy stents are discussed. Copyright © 2013 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.

  1. Square Stent: A New Self-Expandable Endoluminal Device and Its Applications

    SciTech Connect

    Pavcnik, Dusan; Uchida, Barry; Timmermans, Hans; Keller, Frederick S.; Roesch, Josef

    2001-07-15

    The square stent is a new, simply constructed, self-expanding device that has recently been described. Compared with other stents, the square stent has a minimal amount of metal and thus requires a smaller-diameter catheter for introduction. Despite the small amount of metal present, the square stent has adequate expansile force. We have been evaluating the square stent for various interventional applications. In addition to the basic square stent, combinations of square stents and coverings for square stents were developed and evaluated to expand its uses and indications. One of the coverings tested is a new biomaterial: small intestinal submucosa (SIS). This paper will discuss the various applications of the square stent, which include a retrievable inferior vena cava filter, vascular occluder, graft adapter, and venous and aortic valves. In addition, we will review the important properties of SIS as a covering for the square stent.

  2. Differences in Endothelial Injury After Balloon Angioplasty, Insertion of Balloon-Expanded Stents or Release of Self-Expanding Stents: An Electron Microscopic Experimental Study

    SciTech Connect

    Harnek, Jan; Zoucas, Evita; Carlemalm, Erik; Cwikiel, Wojciech

    1999-01-15

    Purpose: To evaluate which of six different commonly available stents inserted into an artery without percutaneous transluminal angioplasty (PTA) causes the least endothelial damage. To compare the degree of endothelial injury after insertion of such a stent with injury caused by PTA. Methods: Twelve healthy pigs were used in the experiments. In the first part of the study six different types of stents were inserted into the common iliac arteries. In the second part of the study self-expanding stents with large spaces between the wires were used. PTA was performed in the contralateral iliac artery. The pigs were killed immediately after the procedure and resected specimens examined after fixation, using scanning electron microscopy. Results: All procedures but two were accomplished successfully. More endothelium was preserved after insertion of self-expanding stents with large spaces between the wires, compared with stents with small spaces and balloon-expanded stents. After insertion of self-expanding stents with large spaces, 50.1% {+-} 16.4% of the endothelium remained intact, compared with only 5.6% {+-} 7.7% after PTA. The difference was statistically significant (p < 0.001). Conclusion: Self-expanding stents with large spaces between the wires, inserted without PTA, cause less damage to the endothelium than other stents and significantly less damage than PTA.

  3. Polymeric photosensitizer-embedded self-expanding metal stent for repeatable endoscopic photodynamic therapy of cholangiocarcinoma.

    PubMed

    Bae, Byoung-chan; Yang, Su-Geun; Jeong, Seok; Lee, Don Haeng; Na, Kun; Kim, Joon Mee; Costamagna, Guido; Kozarek, Richard A; Isayama, Hiroyuki; Deviere, Jacques; Seo, Dong Wan; Nageshwar Reddy, D

    2014-10-01

    Photodynamic therapy (PDT) is a new therapeutic approach for the palliative treatment of malignant bile duct obstruction. In this study, we designed photosensitizer-embedded self-expanding nonvascular metal stent (PDT-stent) which allows repeatable photodynamic treatment of cholangiocarcinoma without systemic injection of photosensitizer. Polymeric photosensitizer (pullulan acetate-conjugated pheophorbide A; PPA) was incorporated in self-expanding nonvascular metal stent. Residence of PPA in the stent was estimated in buffer solution and subcutaneous implantation on mouse. Photodynamic activity of PDT-stent was evaluated through laserexposure on stent-layered tumor cell lines, HCT-116 tumor-xenograft mouse models and endoscopic intervention of PDT-stent on bile duct of mini pigs. Photo-fluorescence imaging of the PDT-stent demonstrated homogeneous embedding of polymeric Pheo-A (PPA) on stent membrane. PDT-stent sustained its photodynamic activities at least for 2 month. And which implies repeatable endoscopic PDT is possible after stent emplacement. The PDT-stent after light exposure successfully generated cytotoxic singlet oxygen in the surrounding tissues, inducing apoptotic degradation of tumor cells and regression of xenograft tumors on mouse models. Endoscopic biliary in-stent photodynamic treatments on minipigs also suggested the potential efficacy of PDT-stent on cholangiocarcinoma. In vivo and in vitro studies revealed our PDT-stent, allows repeatable endoscopic biliary PDT, has the potential for the combination therapy (stent plus PDT) of cholangiocarcinoma. Copyright © 2014 Elsevier Ltd. All rights reserved.

  4. Propensity Score Analysis Comparing Clinical Outcomes of Drug-Eluting vs Bare Nitinol Stents in Femoropopliteal Lesions.

    PubMed

    Soga, Yoshimitsu; Takahara, Mitsuyoshi; Iida, Osamu; Nakano, Masatsugu; Yamauchi, Yasutaka; Zen, Kan; Kawasaki, Daizo; Ando, Kenji

    2016-02-01

    To present a propensity score matching analysis comparing the 1-year outcomes of de novo femoropopliteal lesions treated with drug-eluting stents (DES) or bare nitinol stents (BNS). A retrospective review was conducted of 452 limbs in 389 patients (mean age 74±8 years; 284 men) treated with DES implantation and 1808 limbs in 1441 patients (mean age 72±9 years; 1023 men) implanted with BNS for de novo femoropopliteal lesions. One-year follow-up data were available on all patients. The primary endpoint was 12-month restenosis assessed by duplex ultrasonography or follow-up angiography within ±2 months. Secondary endpoint was major adverse limb events (MALE) including major amputation, any reintervention, and restenosis. The BNS group was more likely to have current smoking, chronic total occlusion, and poor below-the-knee runoff. The stratification analysis demonstrated that diabetes mellitus (DM) and reference vessel diameter (RVD) had a significant interaction on the association of DES vs BNS implantation with restenosis (interaction p<0.05). Thus, the population was stratified into 4 subgroups (1: -DM, RVD ≥5 mm, 2: +DM, RVD ≥5 mm, 3: -DM, RVD <5 mm, and 4: +DM, RVD <5 mm); the RVD threshold was empirically determined. There were no significant intergroup differences in baseline variables after matching. There was no significant difference in restenosis risk between DES and BNS in the RVD ≥5 mm subgroup regardless of the presence of DM. The DES group had a significantly higher restenosis risk in the RVD <5 mm subgroup regardless of the presence of DM. No significant difference was observed in the risk of major amputation, reintervention, or MALE in any subgroup. These results suggest that a first-generation DES was not superior to a conventional BNS for femoropopliteal lesions. © The Author(s) 2015.

  5. Analysis of New Nitinol Ingot Qualities

    NASA Astrophysics Data System (ADS)

    Steegmüller, Rainer; Ulmer, Jochen; Quellmalz, Michael; Wohlschlögel, Markus; Schüßler, Andreas

    2014-07-01

    New ingot qualities, processed by optimized vacuum arc remelting (VAR), optimized vacuum induction melting followed by VAR and VAR followed by electron beam remelting, were compared with standard quality. Finished components as well as diamond-shaped samples representing a typical dimension of self-expanding stents were produced using Nitinol tubing drawn from the new ingot qualities. Metallographic longitudinal sections were prepared and analyzed to determine inclusion size and distributions of the various ingot qualities. Radial force and uniaxial tensile tests were used to determine the mechanical properties of fully processed material and tubing, respectively. Transformation temperatures of tubing as delivered from supplier and processed stents were measured by differential scanning calorimetry and deformation-and-free-recovery testing. Finally, fatigue tests were performed on diamond-shaped samples to evaluate the strain-life characteristics of the new ingot qualities. Results of this study are compared to ADMEDES historical data from standard Nitinol materials to gain an assessment of the new improved ingot qualities with regard to the production of Nitinol vascular implants. The latest developments in Nitinol ingot quality are highlighted and the results of the comparison from technical point of view are shown.

  6. 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.

  7. Determining Micromechanical Strain in Nitinol

    SciTech Connect

    Strasberg, Matthew; /SLAC

    2006-09-27

    Nitinol is a superelastic alloy made of equal parts nickel and titanium. Due to its unique shape memory properties, nitinol is used to make medical stents, lifesaving devices used to allow blood flow in occluded arteries. Micromechanical models and even nitinol-specific finite element analysis (FEA) software are insufficient for unerringly predicting fatigue and resultant failure. Due to the sensitive nature of its application, a better understanding of nitinol on a granular scale is being pursued through X-ray diffraction techniques at the Stanford Synchrotron Radiation Laboratory (SSRL) at the Stanford Linear Accelerator Center (SLAC). Through analysis of powder diffraction patterns of nitinol under increasing tensile loads, localized strain can be calculated. We compare these results with micromechanical predictions in order to advance nitinol-relevant FEA tools. From this we hope to gain a greater understanding of how nitinol fatigues under multi-axial loads.

  8. A comparison of FE beam and continuum elements for typical nitinol stent geometries

    NASA Astrophysics Data System (ADS)

    Ballew, Wesley; Seelecke, Stefan

    2009-03-01

    With interest in improved efficiency and a more complete description of the SMA material, this paper compares finite element (FE) simulations of typical stent geometries using two different constitutive models and two different element types. Typically, continuum elements are used for the simulation of stents, for example the commercial FE software ANSYS offers a continuum element based on Auricchio's SMA model. Almost every stent geometry, however, is made up of long and slender components and can be modeled more efficiently, in the computational sense, with beam elements. Using the ANSYS user programmable material feature, we implement the free energy based SMA model developed by Mueller and Seelecke into the ANSYS beam element 188. Convergence behavior for both, beam and continuum formulations, is studied in terms of element and layer number, respectively. This is systematically illustrated first for the case of a straight cantilever beam under end loading, and subsequently for a section of a z-bend wire, a typical stent sub-geometry. It is shown that the computation times for the beam element are reduced to only one third of those of the continuum element, while both formulations display a comparable force/displacement response.

  9. Response of Balloon-Expandable Endoprosthetic Metallic Stents Subjected to Over-Expansion In Vitro

    SciTech Connect

    Montague, B. J.; Kakimoto, W. M.; Arepally, A.; Razavi, M.; Dake, M. D.; Hofmann, L. V.

    2004-03-15

    We attempted to evaluate the in vitro behavior and performance of balloon-expandable endoprosthetic metallic stents subjected to over-expansion (OE). Seventy-two balloon-expandable endoprosthetic stents, representing 22 models from six manufacturers, were over- expanded in vitro. Stents were initially expanded to their maximum manufacturer- recommended diameter and then over-expanded incrementally to their endpoints. Endpoints for OE were either stent disarticulation or an inability to undergo further expansion despite balloon insufflation to maximum burst pressure. Measurements of stent dimensions were recorded at each overexpanded diameter and comparisons were made to manufacturer's specifications. A total of 288 balloon-driven expansions were performed on 72 stents. Sixteen stents were expanded to large diameters ({>=} 16 mm), 20 stents underwent OE of 50% or greater. One model tended to disarticulate after OE greater than 50%. There were five models that had a tendency to disarticulate after minimal OE. Five models were resistant to OE (25% or less OE) but did not disarticulate. Nearly all stents showed some degree of foreshortening with OE, while 36 stents underwent foreshortening of 30% or more. Models that are not recommended for OE include Intrastent, Intrastent DoubleStrut, NIR Royale and Omniflex. Good candidates for OE include Intrastent DoubleStrut LD, Palmaz large, Medtronic Extra Support Biliary Plus and Medtronic Flexible Biliary. Palmaz XL remains the only model available for expansion from 20 to 28 mm in diameter. For the remaining stents, OE is possible, however, caution should be used.

  10. Circumferential watertight dural repair using nitinol U-clips in expanded endonasal and sublabial approaches to the cranial base.

    PubMed

    Acerbi, Francesco; Genden, Eric; Bederson, Joshua

    2010-12-01

    In recent years, significant advances have been made in the field of expanded endonasal approaches that permit treatment of different cranial base intradural lesions. To report our technique of cranial base dural repair by the application of nitinol U-Clips in endoscope-assisted extended endonasal or sublabial approaches. Closure techniques and postoperative cerebrospinal (CSF) leaks are reported. We reviewed 11 patients with different kinds of cranial base tumors or vascular diseases (2 tuberculum sellae meningiomas, 1 planum sphenoidale meningioma, 4 craniopharyngiomas, 1 recurrent clival chordoma, 1 esthesioneuroblastoma, 1 ethmoidal melanoma metastasis, 1 basilar trunk aneurysm) who underwent an endoscope-assisted extended endonasal or sublabial approach. Dural repair was performed using nitinol U-Clips to circumferentially suture AlloDerm or fascia lata directly to the existing dural borders. Lumbar drainage was not used in 9 patients and was used in 2 patients for 5 days. Patients were evaluated for the appearance of CSF leaks. Postoperative CSF leak was observed in 1 patient (9%). This required a second transnasal repair. Circumferential dural closure with U-Clips is a useful adjunct to prevent CSF leaks after expanded endonasal or sublabial approaches to the cranial base for treatment of intracranial pathology.

  11. Bench-top Comparison of Physical Properties of 4 Commercially-Available Self-Expanding Intracranial Stents

    PubMed Central

    Cho, Su-hee; Jo, Won-il; Jo, Ye-eun; Yang, Ku Hyun; Park, Jung Cheol

    2017-01-01

    Purpose To better understand the performance of four commercially available neurovascular stents in intracranial aneurysm embolization, the stents were compared in terms of their basic morphological and mechanical properties. Materials and Methods Four different types of stents that are currently being used for cerebral aneurysm embolization were prepared (two stents per type). Two were laser-cut stents (Neuroform and Enterprise) and two were braided from a single nitinol wire (LEO and LVIS stents). All were subjected to quantitative measurements of stent size, pore density, metal coverage, the force needed to load, push, and deploy the stent, radial force on deployment, surface roughness, and corrosion resistance. Results Compared to their nominal diameters, all stents had greater diameters after deployment. The length generally decreased after deployment. This was particularly marked in the braided stents. The braided stents also had higher pore densities than the laser-cut stents. Metal coverage was highest in the LEO stent (14%) and lowest in the Enterprise stent (5%). The LIVS stent had the highest microcatheter loading force (81.5 gf). The LEO stent had the highest passage force (55.0 gf) and deployment force (78.9 gf). The LVIS and LEO stents had the highest perpendicular (37.1 gf) and circumferential (178.4 gf) radial forces, respectively. The Enterprise stent had the roughest stent wire, followed by the LVIS, LEO, and Neuroform stents. Conclusion The four neurovascular stent types differed in terms of morphological and physical characteristics. An understanding of this diversity may help to decide which stent is most suitable for specific clinical situations. PMID:28316867

  12. 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.

  13. Midterm Patency After Femoropopliteal Interventions: A Comparison of Standard and Interwoven Nitinol Stents and Drug-Coated Balloons in a Single-Center, Propensity Score-Matched Analysis.

    PubMed

    Steiner, Sabine; Schmidt, Andrej; Bausback, Yvonne; Piorkowski, Michael; Werner, Martin; Yahiaoui-Doktor, Maryam; Banning-Eichenseer, Ursula; Scheinert, Dierk

    2016-04-01

    To describe and compare primary patency rates in patients undergoing endovascular femoropopliteal interventions with standard or interwoven nitinol stents or drug-coated balloons. A cohort of 1292 patients was treated for symptomatic femoropopliteal occlusive disease classified as Rutherford category ≥ 1 at a large vascular center between June 2006 and August 2013 using either standard nitinol stents (SNS; n=432), interwoven nitinol stents (INS; n=470), or drug-coated balloons (DCB; n=390). Primary patency rates were assessed by ultrasound or angiographic readings for over 3 years of follow-up. Propensity score-matched pairs were formed to compare each treatment with another using survival analysis. Survival curves of primary patency favored INS compared with SNS in 368 propensity score-matched pairs (p<0.001). Kaplan-Meier estimates at 1, 2, and 3 years were 86.6%, 76.4%, and 68.9%, respectively, in the INS group vs 60.5%, 46.1%, and 42.1%, respectively, in the SNS group. No significant difference (p=0.232) was seen for the comparison of SNS vs DCB in 284 matched pairs over long-term follow-up (primary patency estimates at 1, 2, and 3 years were 79.8%, 53.8%, and 32.9%, respectively, in the DCB group vs 60.5%, 44.8%, and 40.3%, respectively, in the SNS group). Survival curves of primary patency favored INS over DCB in 254 matched pairs (p<0.001). Kaplan-Meier estimates at 1, 2, and 3 years were 79.0%, 51.2%, and 30.1%, respectively, in the DCB group vs 89.0%, 76.9%, and 66.2%, respectively, in the INS group. Propensity score-based analysis of primary patency suggests profound differences in restenosis rates between various treatment modalities for femoropopliteal disease for over 3 years of follow-up. © The Author(s) 2016.

  14. Emerging Stent and Balloon Technologies in the Femoropopliteal Arteries

    PubMed Central

    Pastromas, Georgios; Katsanos, Konstantinos; Krokidis, Miltiadis; Karnabatidis, Dimitrios

    2014-01-01

    Endovascular procedures for the management of the superficial femoral (SFA) and popliteal artery disease are increasingly common. Over the past decade, several stent technologies have been established which may offer new options for improved clinical outcomes. This paper reviews the current evidence for SFA and popliteal artery angioplasty and stenting, with a focus on randomized trials and registries of nitinol self-expanding stents, drug-eluting stents, dug-coated balloons, and covered stent-grafts. We also highlight the limitations of the currently available data and the future routes in peripheral arterial disease (PAD) stent and balloon technology. PMID:24672355

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

    SciTech Connect

    Crisostomo, Veronica; Uson-Gargallo, Jesus

    2007-07-15

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

  16. Use of a New Hybrid Heparin-Bonded Nitinol Ring Stent in the Popliteal Artery: Procedural and Mid-term Clinical and Anatomical Outcomes

    SciTech Connect

    Parthipun, Aneeta; Diamantopoulos, Athanasios; Kitrou, Panagiotis; Padayachee, Soundrie; Karunanithy, Narayan; Ahmed, Irfan; Zayed, Hany; Katsanos, Konstantinos E-mail: katsanos@med.upatras.gr

    2015-08-15

    PurposeTo report the immediate and mid-term clinical and anatomical outcomes of a novel, hybrid, heparin-bonded, nitinol ring stent (TIGRIS; Gore Medical) when used for the treatment of lesions located in the popliteal artery.Materials and MethodsThis was a prospective single-centre registry. Patients eligible for inclusion were individuals suffering from symptomatic popliteal arterial occlusive disease (Rutherford–Becker stage 3–6; P1–P3 segments) and treated with placement of the TIGRIS stent(s). Patients were prospectively scheduled for clinical review and duplex ultrasound follow-up after 6 and 12 months. Outcome measures included immediate technical success, primary vessel patency, in-stent binary restenosis (evaluable by Duplex at 50 % threshold; PSVR > 2.0), freedom from target lesion revascularization (TLR) and amputation-free survival (AFS) estimated by Kaplan–Meier (K–M) survival analysis. Cox proportional-hazards regression analysis was also performed to adjust for confounders and search for independent predictors of outcomes.ResultsFrom August 2012 to March 2014, a total of 54 popliteal TIGRIS stents were implanted in 50 limbs of 48 patients (27 men and 21 women; mean age 76.0 ± 1.7 years). Median Rutherford–Becker stage was five at baseline and 37/50 (74.0 %) were chronic total occlusions. Technical success was achieved in all cases (100 %). Stented lesion length was 114.2 ± 36.9 mm (range 6–20 cm). Median follow-up was 11.8 ± 0.8 months. After 12 months, primary patency of the TIGRIS stent was 69.5 ± 10.2 % with an 86.1 ± 5.9 % freedom from TLR and 87 ± 5.0 % AFS (K–M estimates).ConclusionThe TIGRIS hybrid heparin-bonded nitinol ring stent is a safe and effective endovascular option for complex occlusive disease of the popliteal artery.

  17. Comparison of the Fatigue Performance of Commercially Produced Nitinol Samples versus Sputter-Deposited Nitinol

    NASA Astrophysics Data System (ADS)

    Siekmeyer, Gerd; Schüßler, Andreas; de Miranda, Rodrigo Lima; Quandt, Eckhard

    2014-07-01

    Self-expanding vascular implants are typically manufactured from Nitinol tubing, using laser cutting, shape setting, and electropolishing processes. The mechanical and fatigue behavior of those devices are affected by the raw material and its processing such as the melting process and subsequent warm and cold forming processes. Current trends focus on the use of raw material with fewer inclusions to improve the fatigue performance. Further device miniaturization and higher fatigue life requirements will drive the need toward smaller inclusions and new manufacturing methods. As published previously, the high-cycle fatigue region of medical devices from standard processed Nitinol is usually about 0.4-0.5% half-alternating strain. However, these results highly depend on the ingot and semi-finished materials, the applied manufacturing processes, the final dimensions of test samples, and applied test methods. Fabrication by sputter deposition is favorable, because it allows the manufacturing of micro-patterned Nitinol thin-film devices without small burrs, heat-affected zones, microcracks, or any contamination with carbides, as well as the fabrication of complex components e.g., 3D geometries. Today, however, there is limited data available on the fatigue behavior for real stent devices based on such sputter-deposited Nitinol. A detailed study (e.g., using metallographic methods, corrosion, tensile, and fatigue testing) was conducted for the first time in order to characterize the micro-patterned Nitinol thin-film material.

  18. Safety and efficacy of the EPIC™ nitinol vascular stent system for the treatment of lesions located in the superficial femoral artery: prospective and multicentric trial.

    PubMed

    Nasser, Felipe; Kambara, Antonio; Abath, Carlos; Cavalcanti, Douglas; Barros, Ilana; Pires, Norma; Rivera, Marco; Neser, Adnan; Ingrund, Jose; Burihan, Marcelo; Silveira, Pierre; Galego, Gilberto; Bortoluzzi, Cristiano; Franklin, Rafael; Bosiers, Marc; Deloose, Koen; Razuk, Alvaro; Caffaro, Roberto; Karakhanian, Walter K; Park, Jong; Lopes, Caetano; Pinto, Daniel; Bez, Leonardo; Lopes, Rodrigo; Mourão, André; Kleinsorge, Gustavo

    2017-06-01

    The aim of this study was to evaluate the short and mid-term safety and efficacy of the EPIC™ nitinol vascular stent system for the treatment of lesions located in the superficial femoral artery (SFA). From October 2010 to June 2012, 83 subjects were enrolled in a prospective, multicenter, non-randomized study designed to demonstrate that the EPIC nitinol vascular stent system for SFA lesions is non-inferior to the published patency rates found in literature. Inclusion criteria were stenosis or occlusion of the SFA or SFA and proximal popliteal artery, with total length from 4 to 11 cm and amenable for treatment with a single stent, in patients with a score from 2 to 5 on Rutherford classification. The primary endpoint was primary patency rate at 12 months as determined by Duplex ultrasound. The secondary endpoints evaluated were: initial arteriographic success, primary patency rate at 6 months, major adverse event rate at one year and technical success. Follow-up with a complete clinical and physical exam, including ABI and Duplex ultrasound was performed at 6 and 12 months. Most patients (56.6%) were men and the mean age was 68.59 (33.1-99.15) years. 25.3% of the total population had intermittent claudication and 73.5% presented with critical limb ischemia. Most lesions were total occlusions (75.9%) and the mean lesion length was 71.16 mm. Contralateral femoral access was performed in 26.5%cases, and ipsilateral femoral approach was used for the remaining 73.5% patients. Technical and arteriographic success was obtained in all 83 (100.00%) patients. Duplex controlled primary patency rate at 6 and 12 months was 95.8% and 76.1%, respectively. The freedom from target lesion revascularization rate was 98.7% and 92.6% at 6 and 12 months, respectively. No stent fractures were observed in this study. Major adverse event rate at 1 year (clinically driven TLR, major amputation, and all-cause mortality) was 15.7%: two target lesion revascularizations (2.4%), one major

  19. Implantability, Complications, and Follow-Up After Transjugular Intrahepatic Portosystemic Stent-Shunt Creation With the 6F Self-Expanding Sinus-SuperFlex-Visual Stent

    PubMed Central

    Spira, Daniel; Wiskirchen, Jakub; Lauer, Ulrich; Ketelsen, Dominik; Nikolaou, Konstantin; Wiesinger, Benjamin

    2016-01-01

    Background The transjugular intrahepatic portosystemic stent-shunt (TIPSS) builds a shortcut between the portal vein and a liver vein, and represents a sophisticated alternative to open surgery in the management of portal hypertension or its complications. Objectives To describe clinical experiences with a low-profile nitinol stent system in TIPSS creation, and to assess primary and long-term success. Patients and Methods Twenty-six patients (5 females, 21 males; mean age 54.6 years) were treated using a low-profile 6F self-expanding sinus-SuperFlex-Visual stent system. The indication for TIPSS creation was refractory bleeding in 9 of the 26 patients, refractory ascites in 18 patients, and acute thrombosis of the portal vein confluence in one patient. Portosystemic pressure gradients before and after TIPSS, periprocedural and long-term complications, and the time to orthotopic liver transplantation (OLT) or death were recorded. Results The portosystemic pressure gradient was significantly reduced, from 20.9 ± 6.3 mmHg before to 8.2 ± 2.3 mmHg after TIPSS creation (P < 0.001). Procedure-related complications included acute tract occlusion (n = 2), liver hematoma (n = 1), hepatic encephalopathy (n = 1), and cardiac failure (n = 1). Three of the 26 patients had late-onset TIPSS occlusion (at 12, 12, and 39 months after TIPSS creation). Three patients died within one week after the procedure due to their poor general condition (multiorgan failure, acute respiratory distress syndrome, necrotizing pancreatitis, and aspiration pneumonia). Another four patients succumbed to their underlying advanced liver disease within one year after TIPSS insertion. Seven patients underwent OLT at a mean time of 9.4 months after TIPSS creation. Conclusion The sinus-SuperFlex-Visual stent system can be safely deployed as a TIPSS device. The pressure gradient reduction was clinically sufficient to treat the patients’ symptoms, and periprocedural complications were due to the TIPSS

  20. Tracheobronchial tree: expandable metallic stents used in experimental and clinical applications. Work in progress.

    PubMed

    Wallace, M J; Charnsangavej, C; Ogawa, K; Carrasco, C H; Wright, K C; McKenna, R; McMurtrey, M; Gianturco, C

    1986-02-01

    An expandable stainless steel stent was formulated for use in the treatment of tracheobronchial stenosis, tracheomalacia, and airway collapse following tracheal reconstruction. The stents were placed through an endotracheal tube into the trachea and bronchi of 11 healthy dogs. The stents expanded over time, substantially increasing the diameter of the lumen. Slight migration occasionally occurred, while an inflammatory reaction was noted in each animal. The stents were successfully used in the treatment of two cancer patients to dilate a postoperative bronchial stenosis that caused pneumonia and to support a tracheal graft that collapsed with respiration. Because of the stent migration in experimental studies, designs are being tested to develop stents with greater stability. These stents may be effective in overcoming stenosis caused by scarring, extrinsic compression, and collapse of reconstructed tracheobronchial structures.

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

    NASA Astrophysics Data System (ADS)

    Chennupati, Raja S.; Trowers, Eugene A.

    2000-05-01

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

  2. Intravascular US-guided direct intrahepatic portocaval shunt with an expanded polytetrafluoroethylene-covered stent-graft.

    PubMed

    Hoppe, Hanno; Wang, Stephen L; Petersen, Bryan D

    2008-01-01

    To retrospectively evaluate the midterm patency rate of the nitinol (Viatorr, W.L. Gore and Associates, Flagstaff, Ariz) stent-graft for direct intrahepatic portacaval shunt (DIPS) creation. Institutional Review Board approval for this retrospective HIPAA-compliant study was obtained with waiver of informed consent. DIPS was created in 18 men and one woman (median age, 54 years; range, 45-65 years) by using nitinol polytetrafluoroethylene (PTFE)-covered stent-grafts. The primary indications were intractable ascites (n = 14), acute variceal bleeding (n = 3), and hydrothorax (n = 2). Follow-up included Doppler ultrasonography at 1, 6, and 12 months and venography with manometry at 6-month intervals after the procedure. Shunt patency and cumulative survival were evaluated by using the Kaplan-Meier method and survival curves were plotted. Differences in mean portosystemic gradients (PSGs) were evaluated by using the Student t test. Multiple regression analysis for survival and DIPS patency were performed for the following parameters: Child-Pugh class, model of end-stage liver disease score, pre- and post-DIPS PSGs, pre-DIPS liver function tests, and pre-DIPS creatinine levels. DIPS creation was successful in all patients. Effective portal decompression and free antegrade shunt flow was achieved in all patients. Intraperitoneal bleeding occurred in one patient during the procedure and was controlled during the same procedure by placing a second nitinol stent-graft. The primary patency rate was 100% at all times during the follow-up period (range, 2 days to 30 months; mean, 256 days; median, 160 days). Flow restrictors were deployed in two (11%) of 19 patients. The 1-year mortality rate was 37% (seven of 19). Patency after DIPS creation with the nitinol PTFE-covered stent-graft was superior to that after TIPS with the nitinol stent-graft. RSNA, 2008

  3. 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

  4. Totally extraperitoneal laparoscopic inguinal hernia repair using a self-expanding nitinol framed hernia repair device: A prospective case series.

    PubMed

    D'Hondt, Mathieu; Nuytens, Frederiek; Yoshihara, Emi; Adriaens, Els; Vansteenkiste, Franky; Pottel, Hans

    2017-04-01

    The use of a self-expanding nitinol framed prosthesis (ReboundHRD(®)) for totally extraperitoneal laparoscopic inguinal hernia repair (TEP-IHR) could solve issues of mesh shrinkage and associated pain. We prospectively evaluated the use of the ReboundHRD(®) mesh for TEP-IHR. All patients who underwent a TEP-IHR using the ReboundHRD(®) Large mesh from April 2014 till May 2015, were included. No mesh fixation was performed. Follow-up assessments were performed at the day of surgery, 1, 2, and 7 days, 1, 3, 6, and 12 months. Outcome measures include post-operative pain (visual analogue scale, VAS), operative details, complications, and recurrence rate. In total, 69 TEP-IHR procedures were performed in 54 patients (15 bilateral hernias). No perioperative and 5 (9%) postoperative complications occurred, all graded Clavien-Dindo I-II. The median length of stay was 1 day (range 0-3), with 78% of the operations performed in an ambulatory setting. Median VAS score decreased from 3 (range 0-4) on the day of surgery to 1 (range 0-2) on day 7. Patients were completely pain-free at a median time of 5 (range 1-60) days. The majority (80.4%, 37/46) of the active patients went back to work within 2 weeks (maximum 6 weeks). At a median follow-up of 19 months (range 16-26 months), no recurrences occurred. TEP-IHR using a self-expanding nitinol framed hernia repair device is a safe technique in longterm follow-up. The technique is associated with a low incidence of postoperative pain, a short hospital stay and quick return to normal activities. Copyright © 2017 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.

  5. Understanding the requirements of self-expandable stents for heart valve replacement: Radial force, hoop force and equilibrium.

    PubMed

    Cabrera, María Sol; Oomens, Cees W J; Baaijens, Frank P T

    2017-04-01

    A proper interpretation of the forces developed during stent crimping and deployment is of paramount importance for a better understanding of the requirements for successful heart valve replacement. The present study combines experimental and computational methods to assess the performance of a nitinol stent for tissue-engineered heart valve implantation. To validate the stent model, the mechanical response to parallel plate compression and radial crimping was evaluated experimentally. Finite element simulations showed good agreement with the experimental findings. The computational models were further used to determine the hoop force on the stent and radial force on a rigid tool during crimping and self-expansion. In addition, stent deployment against ovine and human pulmonary arteries was simulated to determine the hoop force on the stent-artery system and the equilibrium diameter for different degrees of oversizing.

  6. Benign and malignant esophageal strictures: treatment with a polyurethane-covered retrievable expandable metallic stent.

    PubMed

    Song, H Y; Park, S I; Jung, H Y; Kim, S B; Kim, J H; Huh, S J; Kim, T H; Kim, Y K; Park, S; Yoon, H K; Sung, K B; Min, Y I

    1997-06-01

    To evaluate the clinical effectiveness of a polyurethane-covered, retrievable, self-expandable metallic stent and hook catheter in the treatment of esophageal strictures. Stents were constructed of 0.4-mm stainless steel wire in a cylindric zig-zag configuration of six to nine bends. Four to eight stents were connected in tandem by dipping in a polyurethane solution. A nylon loop was hooked inside to each bend of the proximal portion of the stent and strung with a thread. Under fluoroscopic guidance, 22 stents were placed in 16 patients with a malignant stricture and five patients with a benign stricture. The stent was removed with a hook catheter 2 months after placement in patients with a benign stricture and when complications occurred in patients with a malignant stricture. All patients had dysphagia with ingestion of soft foods or liquids. Stent placement was technically successful and well tolerated in 20 patients. In one patient, the stent was misplaced but relocated successfully. After stent placement, all patients were able to ingest solid and/or soft foods without dysphagia. After stent removal, strictures showed improvement but recurred in two patients. Use of polyurethane-covered, retrievable expandable stents seems to be a feasible and effective method of treatment of benign and malignant esophageal strictures.

  7. Sequential Structural and Fluid Dynamics Analysis of Balloon-Expandable Coronary Stents: A Multivariable Statistical Analysis.

    PubMed

    Martin, David; Boyle, Fergal

    2015-09-01

    Several clinical studies have identified a strong correlation between neointimal hyperplasia following coronary stent deployment and both stent-induced arterial injury and altered vessel hemodynamics. As such, the sequential structural and fluid dynamics analysis of balloon-expandable stent deployment should provide a comprehensive indication of stent performance. Despite this observation, very few numerical studies of balloon-expandable coronary stents have considered both the mechanical and hemodynamic impact of stent deployment. Furthermore, in the few studies that have considered both phenomena, only a small number of stents have been considered. In this study, a sequential structural and fluid dynamics analysis methodology was employed to compare both the mechanical and hemodynamic impact of six balloon-expandable coronary stents. To investigate the relationship between stent design and performance, several common stent design properties were then identified and the dependence between these properties and both the mechanical and hemodynamic variables of interest was evaluated using statistical measures of correlation. Following the completion of the numerical analyses, stent strut thickness was identified as the only common design property that demonstrated a strong dependence with either the mean equivalent stress predicted in the artery wall or the mean relative residence time predicted on the luminal surface of the artery. These results corroborate the findings of the large-scale ISAR-STEREO clinical studies and highlight the crucial role of strut thickness in coronary stent design. The sequential structural and fluid dynamics analysis methodology and the multivariable statistical treatment of the results described in this study should prove useful in the design of future balloon-expandable coronary stents.

  8. Design method of self-expanding stents suitable for the patient's condition.

    PubMed

    Yoshino, D; Inoue, K

    2010-01-01

    A medical device of mesh-shaped tubular structure, called a stent, is frequently used to expand the stenosis of a blood vessel. The stent normally has the structure of longitudinally repeated wavy wire parts and strut parts, and its mechanical properties, such as bending flexibility and rigidity in the radial direction, mainly depend on the shape of the wavy wire and the construction of the strut. This paper presents, a design support system for self-expanding stents that can design stent shape and evaluate stent performance as routine flow. A two-stage method for designing suitable stent shapes is built into this system. The mechanical properties of self-expandable stents are evaluated using a non-linear finite element method. The wire length of the stent and the wire width are adopted as design parameters, and the sensitivity of the mechanical properties to these parameters is obtained. When the patient's conditions, such as blood vessel type and the diameter of the blood vessel with stenosis, are given by medical examination, the performance of the stent in restoring blood flow has to be determined. Finally, a method is proposed for designing suitable stents with the desired performance on the basis of mechanical properties.

  9. Off-resonance magnetic resonance angiography improves visualization of in-stent lumen in peripheral nitinol stents compared to conventional T1-weighted acquisitions: an in vitro comparison study.

    PubMed

    Gitsioudis, Gitsios; Fortner, Philipp; Stuber, Matthias; Missiou, Anna; Andre, Florian; Müller, Oliver J; Katus, Hugo A; Korosoglou, Grigorios

    2016-11-01

    To compare the value of inversion recovery with on-resonant water suppression (IRON) to conventional T1-weighted (T1w) MRA and computed tomography angiography (CTA) for visualization of peripheral nitinol stents. We visualized 14 different peripheral nitinol stents in vitro both using Gadolinium (Gd) and ultrasmall superparamagnetic iron nanoparticles (USPIOs) for conventional T1w and IRON-MRA using clinical grade 1.5T MR scanner and iodinated contrast material for CTA using a 256-slice CT scanner. Parameter assessment included signal- and contrast-to-noise ratio (S/CNR), relative in-stent signal and artificial lumen narrowing. X-ray angiography served as gold standard for diameter assessment. Gd-enhanced IRON-MRA exhibited highest in-stent SNR and CNR values compared to conventional T1w MRA (IRON (Gd/USPIO): SNR = 30 ± 3/21 ± 2, CNR = 23 ± 2/14 ± 1; T1w: SNR = 16 ± 1/14 ± 2, CNR = 12 ± 1/10 ± 1, all p < 0.05). Furthermore, IRON-MRA achieved highest relative in-stent signal both using Gd and USPIO (IRON (Gd/USPIO): 121 ± 8 %/103 ± 6 %; T1w: 73 ± 2 %/66 ± 4 %; CTA: 84 ± 6 %, all p < 0.05). However, artificial lumen narrowing appeared similar in all imaging protocols (IRON (Gd/USPIO): 21 ± 3 %/21 ± 2 %; T1w: 16 ± 4 %/17 ± 3 %; CTA: 19 ± 2 %, all p = NS). Finally, IRON-MRA provided improvement of the in-stent lumen visualization with an 'open-close-open' design, which revealed a complete in-stent signal loss in T1w MRA. IRON-MRA improves in-stent visualization in vitro compared to conventional T1w MRA and CTA. In light of the in vitro results with Gd-enhanced IRON-MRA, the clinical implementation of such an approach appears promising.

  10. Status and Literature Review of Self-Expandable Metallic Stents for Malignant Colorectal Obstruction

    PubMed Central

    Cheung, Dae Young; Lee, Yong Kook

    2014-01-01

    Use of colorectal stents has increased dramatically over the last decades. Colorectal stents offer an alternative way to relieve fatal intestinal obstruction and can take place of emergency surgery, which associated with significant morbidity and mortality and a high incidence of stoma creation, to elective resection. Although there remain a few concerns regarding the use of stents as a bridge to surgical resection, use of self-expandable metallic stents for palliation in patients with unresectable disease has come to be generally accepted. Advantages of colorectal stents include acute restoration of luminal patency and allowance of time for proper staging and surgical optimization, and the well-known disadvantages are procedure-related complications including perforation, migration, and stent failure. General indications, procedures, and clinical outcomes as well as recent evidences regarding the use of colorectal stents will be discussed in this review. PMID:24570885

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

    SciTech Connect

    McQueen, A. S.; Eljabu, W.; Latimer, J. Raju, P. P. J.

    2011-02-15

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

  12. Self-expanding stents and aortoiliac occlusive disease: a review of the literature

    PubMed Central

    Bekken, Joost A; Jongsma, Hidde; de Vries, Jean-Paul PM; Fioole, Bram

    2014-01-01

    The treatment of symptomatic aortoiliac occlusive disease has shifted from open to endovascular repair. Both short- and long-term outcomes after percutaneous angioplasty and stenting rival those after open repair and justify an endovascular-first approach. In this article, we review the current endovascular treatment strategies in patients with aortoiliac occlusive disease, indications for primary and selective stenting in the iliac artery, and physical properties and future perspectives of self-expanding stents. PMID:24833925

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

    PubMed

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

    2013-01-01

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

  14. [Treatment of malignant colorectal obstruction by means of endoscopic insertion of self-expandable metallic stents].

    PubMed

    García-Cano, J; González Martín, J A; Redondo-Cerezo, E; Morillas Ariño, J; Pérez García, J I; Pérez Vigara, M G; Gómez Ruiz, C J; Pérez Sola, A

    2003-10-01

    Self-expandable metallic stents are being used increasingly to treat the obstruction of different segments of the digestive tract and biliary tree. We present our centre experience on the initial resolution of malignant colorectal obstruction by means of this type of stents. During a 18-month period, 13 patients patients suffering from malignant obstruction at the level of rectum, sigmoid or descending colon tried to be initially treated by means of endoscopic insertion of stents (non covered enteral Wallstents). Ten procedures were performed with both endoscopy and fluroscopy and three with only endoscopy. In 12 of the 13 patients (92,3%) the obstruction was solved by means of correct stent insertion. All the exclusively endoscopic procedures (without fluoroscopy) were successful. Six (50 %) patients with tumours at the rectosigmoid underwent later scheduled surgery. In the remaining six ones (a patient with an ovarian carcinoma and five with colonic adenocarcinoma) the stents were considered to be a palliative definitive treatment. Stent migration was observed in two of these patients and both were extracted endoscopically. Only one patient needed to have another stent inserted. A tumoural colo-vesical fistula developed in another patient in the palliative group, inside the previous inserted stent, and was treated by coaxial insertion of an esophageal Ultraflex. There were no other complications or mortality related to the endoscopic procedures. Self-expandable metallic stents might be considered, in general, as the initial treatment for the malignant obstruction at the level of rectum, sigmoid and descending colon

  15. 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.

  16. Expandable polyester silicon-covered stent for malignant esophageal strictures before neoadjuvant chemoradiation: a pilot study.

    PubMed

    Siddiqui, Ali A; Loren, David; Dudnick, Robert; Kowalski, Thomas

    2007-03-01

    Patients with resectable esophageal cancer often require placement of a surgical jejunostomy tube prior to receiving chemoradiation so as to maintain adequate nutrition due to their inability to swallow and eat. This study reports a single institutional experience with the Polyflex self-expanding silicone stent (Riisch; Kernen. Germany) in patients with malignant stenosis receiving chemoradiation prior to esophagectomy. This was a retrospective, nonrandomized study of 6 patients who underwent Polyflex esophageal stent placement across a malignant stricture prior to receiving neoadjuvant chemoradiation. The study assessed procedural success, restoration of oral nutrition, migration, and removal of the Polyflex stent. The outcomes measured were the efficacy of treatment, stent-related complications, and changes in the nutritional status of the patient after stent placement. Stent placement was successful in 5 of 6 patients (83%). Restoration of oral nutrition after stent placement occurred in 5 of 5 patients (100%). Migration of the stent into the stomach occurred in 3 patients (60%) without occurrence of gastric outlet obstruction; there was no proximal migration. Stents were successfully removed endoscopically or at the time of esophagectomy. This early experience suggests that the removable silicone Polyflex stent is an effective alternative to a surgical jejunostomy tube for the management of malignant esophageal stenosis in patients for whom neoadjuvant chemoradiation is planned prior to esophagectomy.

  17. Design and modeling balloon-expandable coronary stent for manufacturability

    NASA Astrophysics Data System (ADS)

    Suryawan, D.; Suyitno

    2017-02-01

    Coronary artery disease (CAD) is a disease that caused by narrowing of the coronary artery. The narrowing coronary artery is usually caused by cholesterol-containing deposit (plaque) which can cause a heart attack. CAD is the most common cause mortality in Indonesia. The commonly CAD treatment use the stent to opens or alleviate the narrowing coronary artery. In this study, the stent design is optimized for the manufacturability. Modeling is used to determine the free stent expansion due to applied pressure in the inner surface of the stent. The stress distribution, outer diameter change, and dogboning phenomena are investigated in the simulation. The result of modeling and simulating was analyzed and used to optimize the stent design before it is manufactured using EDM (Electric Discharge Machine) in the next research.

  18. Renal Transplant Ureteral Stenosis: Treatment by Self-Expanding Metallic Stent

    SciTech Connect

    Cantasdemir, Murat; Kantarci, Fatih; Numan, Furuzan; Mihmanli, Ismail; Kalender, Betul

    2003-02-15

    We report the use of a metallic stent in a transplant ureteral stenosis. A 28-year-old man with chronic renal failure due to chronic pyelonephritis, who received a living-donor renal transplant, presented with transplant ureteral stenosis. The stenosis was unresponsive to balloon dilation and was treated by antegrade placement of a self-expanding Memotherm stent. The stentedureter stayed patent for 3 years. It may be reasonable to treat post-transplant ureteral stenosis resistant to balloon dilation with self-expanding metallic stents. However, long-term follow-up is required to evaluate the efficacy of this treatment.

  19. [A case of severe motor and intellectual disability with tracheal stenosis due to granulation caused by metal stents treated successfully by silicone stents].

    PubMed

    Kotani, Haruko; Hino, Hiroyuki; Shiraishi, Taisuke; Ogura, Hideo

    2002-11-01

    A silicone stent (Dumon stent) was used in a severe motor and intellectual disability with severe tracheal stenosis due to granulation caused by an implanted the expanded metal stent (Ultraflex Nitinol Stent). To treat tracheobronchial malacia, diagnosed in infancy, expanded metalic stent was implanted at the ages of 30 and 32 years. However, a few months after the second implantation, progressive dyspnea appeared, and he had to use a respirator under intravenous anesthesia. Bronchoscopy showed re-stenosis of the trachea due to a granulation tissue within the stent. A Dumon stent was applied to control the re-stenosis. He was successfully weaned from a respirator. Since granulation tissue had recurred at the end of the Dumon stent after 3 months, a long term care of the airway and regular observation is necessary after implantation of stents.

  20. Preclinical Testing of a Novel Thin Film Nitinol Flow-Diversion Stent in a Rabbit Elastase Aneurysm Model.

    PubMed

    Ding, Y; Dai, D; Kallmes, D F; Schroeder, D; Kealey, C P; Gupta, V; Johnson, A D; Kadirvel, R

    2016-03-01

    Thin film nitinol can be processed to produce a thin microporous sheet with a low percentage of metal coverage (<20%) and high pore attenuation (∼70 pores/mm(2)) for flow diversion. We present in vivo results from the treatment of experimental rabbit aneurysms by using a thin film nitinol-based flow-diversion device. Nineteen aneurysms in the rabbit elastase aneurysm model were treated with a single thin film nitinol flow diverter. Devices were also placed over 17 lumbar arteries to model perianeurysmal branch arteries of the intracranial circulation. Angiography was performed at 2 weeks (n = 7), 1 month (n = 8), and 3 months (n = 4) immediately before sacrifice. Aneurysm occlusion was graded on a 3-point scale (grade I, complete occlusion; grade II, near-complete occlusion; grade III, incomplete occlusion). Toluidine blue staining was used for histologic evaluation. En face CD31 immunofluorescent staining was performed to quantify neck endothelialization. Markedly reduced intra-aneurysmal flow was observed on angiography immediately after device placement in all aneurysms. Grade I or II occlusion was noted in 4 (57%) aneurysms at 2-week, in 6 (75%) aneurysms at 4-week, and in 3 (75%) aneurysms at 12-week follow-up. All 17 lumbar arteries were patent. CD31 staining showed that 75% ± 16% of the aneurysm neck region was endothelialized. Histopathology demonstrated incorporation of the thin film nitinol flow diverter into the vessel wall and no evidence of excessive neointimal hyperplasia. In this rabbit model, the thin film nitinol flow diverter achieved high rates of aneurysm occlusion and promoted tissue in-growth and aneurysm neck healing, even early after implantation. © 2016 by American Journal of Neuroradiology.

  1. A comparison of temporary self-expanding plastic and biodegradable stents for refractory benign esophageal strictures.

    PubMed

    van Boeckel, Petra G A; Vleggaar, Frank P; Siersema, Peter D

    2011-08-01

    It is a challenge to manage refractory benign esophageal strictures (RBES). We compared the efficacy and safety of self-expanding plastic stents (SEPSs) with placement of biodegradable stents for the treatment of RBES. We studied 2 groups of consecutive patients with RBES who received temporary placement (6 weeks) of SEPSs (n = 20) or biodegradable stents (n = 18). Data were collected with respect to clinical outcome, complications, recurrent dysphagia, and reinterventions. SEPSs were removed in 16 (80%) patients. Stent placement was not successful in 1 patient, while stent removal was not performed in another 3 patients. Six (30%) patients with an SEPS were dysphagia-free after a median follow-up of 385 days (range, 77-924 days). Ten (50%) developed recurrent dysphagia. Major complications occurred in 2 patients (10%; 1 with hemorrhage and 1 with perforation). Six patients (33%) with a biodegradable stent were dysphagia-free after a median follow-up of 166 days (range 21-559 days) (P = .83 compared with SEPS). Twelve patients (67%) had recurrent dysphagia. Major complications occurred in 4 patients (22%; 2 with hemorrhage, 2 with severe retrosternal pain) with a biodegradable stent (P = .30 compared with SEPS). Reinterventions were less frequently indicated after biodegradeble stent than after SEPS placement (15 [mean, 0.8 ± 0.6 per stent placed] vs 21 [mean, 1.3 ± 0.4 per stent placed], respectively; P = .03). Placement of SEPSs or biodegradable stents provides long-term relief of dysphagia in 30% and 33%, respectively, of patients with RBES. Biodegradable stents require fewer procedures than SEPSs, offering an advantage. Although stent placement is a viable strategy in patients with RBES, the ideal strategy still needs to be defined. Copyright © 2011 AGA Institute. Published by Elsevier Inc. All rights reserved.

  2. Elastic Deformation Properties of Implanted Endobronchial Wire Stents in Benign and Malignant Bronchial Disease: A Radiographic In Vivo Evaluation

    SciTech Connect

    Hautmann, Hubert; Rieger, Johannes; Huber, Rudolf M.; Pfeifer, Klaus J.

    1999-03-15

    Purpose: To evaluate the long-term mechanical behavior in vivo of expandable endobronchial wire stents, we imaged three different prostheses in the treatment of tracheobronchial disease. Methods: Six patients with bronchial stenoses (three benign, three malignant) underwent insertion of metallic stents. Two self-expandable Wallstents, two balloon-expandable tantalum Strecker stents and two self-expandable nitinol Accuflex stents were used. Measurements of deformation properties were performed during voluntary cough by means of fluoroscopy, at 1 month and 7-10 months after implantation. The procedures were videotaped, their images digitized and the narrowing of stent diameters calculated at intervals of 20 msec. Results: After stent implantation all patients improved with respect to ventilatory function. Radial stent narrowing during cough reached 53% (Wallstent), 59% (tantalum Strecker stent), and 52% (nitinol Accuflex stent) of the relaxed post-implantation diameter. Stent compression was more marked in benign compared with malignant stenoses. In the long term permanent deformation occurred with the tantalum Strecker stents; the other stents were unchanged. Conclusion: Endobronchial wire stents can be helpful in the treatment of major airway collapse and obstructing bronchial lesions. However, evidence of material fatigue as a possible effect of exposure to recurrent mechanical stress on the flexible mesh tube may limit their long-term use. This seems to be predominantly important in benign bronchial collapse.

  3. The Influence of Statin Therapy on Restenosis in Patients Who Underwent Nitinol Stent Implantation for de Novo Femoropopliteal Artery Disease: Two-Year Follow-up at a Single Center.

    PubMed

    Kim, Wonho; Gandhi, Ripal T; Peña, Constantino S; Herrera, Raul E; Schernthaner, Melanie B; Acuña, Juan M; Becerra, Victor N; Katzen, Barry T

    2016-10-01

    To determine whether statin therapy is associated with reduced restenosis following nitinol stent implantation for de novo femoropopliteal artery disease. A total of 135 limbs in 135 patients (mean age, 72 y) implanted with nitinol stents in femoropopliteal occlusions were analyzed (statin arm, n = 91; nonstatin arm, n = 44). The patients were treated with one type of nitinol stent. At baseline, lesions and procedural characteristics were comparable between groups, except that the statin group had more hypertension, coronary artery disease, and hyperlipidemia. There were significant differences in the incidence of binary restenosis between groups at 1 year (45.5% for nonstatin group vs 28.6% for statin group; P = .05) and 2 years (56.8% for nonstatin group vs 38.5% for statin group; P = .04). Primary patency rates at 1 year were 50.5% in the nonstatin group and 72.5% in the statin group (P = .01). Two-year target lesion revascularization rates were 54.5% in the nonstatin group and 35.2% in the statin group (P = .03). On univariate analysis, statin therapy was associated with decreased relative risk of binary restenosis at 1 year (odds ratio [OR], 0.480; 95% confidence interval [CI], 0.227-1.014; P = .050). On multivariate analysis, statin therapy did not significantly affect the odds of binary restenosis (OR, 0.415; 95% CI, 0.071-2.437; P = .330). The incidence of binary restenosis was significantly lower in the statin group than in the nonstatin group following nitinol stent implantation for de novo femoropopliteal artery disease. Copyright © 2016 SIR. Published by Elsevier Inc. All rights reserved.

  4. Self-expanding stent placement for anterior circulation intracranial artery dissection presenting with ischemic symptoms.

    PubMed

    Kim, Dong Joon; Kim, Byung Moon; Suh, Sang Hyun; Kim, Dong Ik

    2015-02-01

    The prognosis of ischemic anterior circulation intracranial dissection (AC-ICD) is poor and its optimal management is still controversial. To evaluate the safety and efficacy of a self-expanding stent for ischemic AC-ICD. Eight patients (mean age, 36 years) underwent self-expanding stenting for ischemic AC-ICD. Imaging findings of ischemic AC-ICD, the reason for stenting, and the clinical and angiographic outcomes were retrospectively evaluated. AC-ICD involved intracranial internal carotid artery to middle cerebral artery (MCA) in 2, intracranial internal carotid artery alone in 3, and MCA alone in 3 patients. Six AC-ICDs showed complete or near occlusions while 2 had a severe degree of stenosis. Six AC-ICDs showed an intimal flap and 3 had intramural hematomas. Six patients underwent emergent stenting for acute stroke within 6 hours (n=2) or crescendo-type stroke within 24 hours (n=4), while 2 patients had stenting for recurrent ischemia on dual antiplatelet and/or anticoagulation after the initial attack. The mean dissection-related stenosis improved from 93.1% to 20.3% after stenting (P<.05). The mean National Institutes of Health Stroke Scale score improved from 7.5 to 1.4 (P<.05). All patients had excellent or favorable outcomes at 3 months: modified Rankin Scale score, 0 in 3, 1 in 3, and 2 in 1 patient(s). No patients had subarachnoid hemorrhage or ischemic symptom recurrence during the clinical follow-up (mean, 27 months). All stented arteries were patent without significant in-stent stenosis on angiographic follow-up (range, 3-12 months). Self-expanding stents seem to be safe and effective for AC-ICD presenting with acute/crescendo-type stroke or recurrent ischemia despite adequate medication.

  5. Management of cervical esophageal strictures with self-expanding metalic stents.

    PubMed

    Cindoruk, Mehmet; Karakan, Tarkan

    2006-12-01

    Esophageal strictures due to malignant diseases are treated with self-expanding metalicic stents. However, experience is limited with these metalic stents in the cervical esophagus. Due to technical difficulties and procedure-related complications, the cervical esophagus has been assigned as a risky area for stenting procedures. Another encountered problem is patient discomfort after the procedure. In this case report, we present three patients with cervical esophageal strictures who were successfully treated with self-expandable metalic stents. Two of these patients had inoperable esophageal carcinoma and the third had benign stenosis due to radiotherapy of larynx carcinoma. The two patients with malignant disease survived four and six months, respectively, after the procedure. The last patient with benign disease is still alive and has been without dysphagia symptom for six months.

  6. Tapered self expandable bare stent to treat acute superior mesenteric artery ischemia.

    PubMed

    Martinez Miguez, Marta; Carballo-Fernandez, Coral; Mosquera-Arochena, Nilo

    2012-01-01

    This case demonstrates the use of carotid stents in off-label emergency condition where standard self-expandable stents doesn't fit to native artery and balloon-expandable stents could not be also recommended. 56 years old patient, EVAR therapy performed 2 months before, suffering acute severe abdominal pain; emergency angioCT showed oclusion of superior mesenteric artery (SMA) and no complications related to previous EVAR. A percutaneuos supraselective trombolysis was performed. After 24 hours control DSA showed partial recanalization and tight stenoses in distal SMA with poor run-off to terminal branches. A 6-8 x 40 mm Carotid Stent (Acculink®, Abbot Vascular) was implanted with good inmediate technical result. After 6 months follow up both SMA and branches remain patent and no further treatment was required. tapered self expandable uncovered stents are a good treatment option to achieve better conformability to SMA,and bare metal stents do not compromise side-branches of this artery.

  7. [Stent for neurovascular diseases].

    PubMed

    Sakai, Nobuyuki; Sakai, Chiaki

    2009-09-01

    A stent is a medical device that can provide scaffolding to vessels and organ walls to keep the arteries open. Different types of stents have been used in the filed of neurovascular diseases, such as atherosclerosis and aneurysms. Carotid artery stenting (CAS) was approved in 2007 in Japan, and it has been widely used as an alternative to carotid endarterectomy (CEA) for treating severe carotid artery stenosis. According to current approval, the indications of carotid artery stenting are observed in high-surgical-risk patients, patients with more than 50% symptomatic stenosis, and those with more than 80% asymptomatic stenosis. The use of nickel-titanium (nitinol) crush-resistant self-expanding stents (Precise) and emblic-protection devices (Angioguard XP) has been approved. Intracranial atherosclerotic disease have frequently posed a risk for recurrent stroke despite the intensive medical treatment. The design of the Wingspan stent system is different from that of balloon-expandable stents. Target lesions are predilated with an undersized angioplasty balloon, followed by stent deployment. Another important indication is for intracranial aneurysms. Since the discovery Guglielmi dechatable coils (GDC) in the early 1990s, endovascular treatment has been drastically improved all over the world. However, a high recurrence rate is observed when large and wide-necked aneurysms are treated with detachble coils. The application of self-expanding stents such as Neuroform, Enterprize, or LEO, is effective for packing coils into the aneurysm, and flow modification effect can be achieved for the curative reconstruction of the parent arteries. Further reserch will confirm the application of stents for the treatment of cerebrovascular disease.

  8. DISCOVER: Dutch Iliac Stent trial: COVERed balloon-expandable versus uncovered balloon-expandable stents in the common iliac artery: study protocol for a randomized controlled trial

    PubMed Central

    2012-01-01

    Background Iliac artery atherosclerotic disease may cause intermittent claudication and critical limb ischemia. It can lead to serious complications such as infection, amputation and even death. Revascularization relieves symptoms and prevents these complications. Historically, open surgical repair, in the form of endarterectomy or bypass, was used. Over the last decade, endovascular repair has become the first choice of treatment for iliac arterial occlusive disease. No definitive consensus has emerged about the best endovascular strategy and which type of stent, if any, to use. However, in more advanced disease, that is, long or multiple stenoses or occlusions, literature is most supportive of primary stenting with a balloon-expandable stent in the common iliac artery (Jongkind V et al., J Vasc Surg 52:1376-1383,2010). Recently, a PTFE-covered balloon-expandable stent (Advanta V12, Atrium Medical Inc., Hudson, NH, USA) has been introduced for the iliac artery. Covering stents with PTFE has been shown to lead to less neo-intimal hyperplasia and this might lower restenosis rates (Dolmatch B et al. J Vasc Interv Radiol 18:527-534,2007, Marin ML et al. J Vasc Interv Radiol 7:651-656,1996, Virmani R et al. J Vasc Interv Radiol 10:445-456,1999). However, only one RCT, of mediocre quality has been published on this stent in the common iliac artery (Mwipatayi BP et al. J Vasc Surg 54:1561-1570,2011, Bekken JA et al. J Vasc Surg 55:1545-1546,2012). Our hypothesis is that covered balloon-expandable stents lead to better results when compared to uncovered balloon-expandable stents. Methods/Design This is a prospective, randomized, controlled, double-blind, multi-center trial. The study population consists of human volunteers aged over 18 years, with symptomatic advanced atherosclerotic disease of the common iliac artery, defined as stenoses longer than 3 cm and occlusions. A total of 174 patients will be included. The control group will undergo endovascular dilatation or

  9. 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.

  10. 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.

  11. A unique complication of self-expandable metal stent placement in malignant duodenal obstruction.

    PubMed

    Down, Christopher J; Kumar, Lalit; Singh, Sukhpal; Veeramootoo, Darmarajah

    2017-09-01

    Intestinal obstruction is a common complication in patients with advanced gastrointestinal malignancies. In the last two decades, endoscopic placement of duodenal stents has become a mainstay of palliative treatment in patients with unresectable obstructive duodenal pathology. Self-expandable metal stents have been reported to have excellent success rates, besides dramatically improve the patient's quality of life by reinstating the oral feeding ability. Re-intervention rates remain high, commonly as a consequence of tumour ingrowth resulting stent occlusion. We describe a unique case of duodenal stent obstruction secondary to impacted gallstones. To the best of our knowledge, this is the first case described in the literature and should alert clinicians to this unusual complication.

  12. Malignant Gastric and Duodenal Stenosis: Palliation by Peroral Implantation of a Self-Expanding Metallic Stent

    SciTech Connect

    Pinto, Isabel T.

    1997-11-15

    Purpose: To assess the use of self-expanding metallic stents in patients with inoperable malignant antrum-pylorus-duodenal obstruction. Methods: Six patients underwent implantation of a Wallstent self-expanding metallic endoprosthesis (20 mm in five patients and 16 mm in one). In five patients a catheter (Berenstein) was introduced perorally into the stomach. A guidewire (Terumo) was introduced through the catheter and advanced through the antrum-pylorus-duodenal stenosis. The guidewire was removed and a 260-cm-long, 0.035'' superstiff guide (Amplatz) was introduced. After the catheter was removed the stent assembly was introduced. In the last patient the stent was implanted through a percutaneous gastrostomy. Results: Treatment of inoperable gastric outlet obstruction caused by tumor compression is difficult and unsatisfactory. Peroral implantation of self-expanding metallic stents resulted in successful palliative therapy of antrum-pylorus-duodenal stenosis in six patients in whom surgery was not possible because of advanced disease and poor general condition. On average, patients were able to eat during 41 days. One patient is tolerating oral intake at 3 months. Conclusion: Implantation of stents resulted in palliative relief of malignant antrum-pylorus-duodenal obstructions.

  13. 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.

  14. Miniaturized Self-Expanding Drug-Eluting Stent in Small Coronary Arteries: Late Effectiveness

    PubMed Central

    de Oliveira, Flavio Roberto Azevedo; Mattos, Luiz Alberto Piva e; Abizaid, Alexandre; Abizaid, Andrea S.; Costa, J. Ribamar; Costa, Ricardo; Staico, Rodolfo; Botelho, Roberto; Sousa, J. Eduardo; Sousa, Amanda

    2013-01-01

    Background Small vessels represent a risk factor for restenosis in percutaneous coronary angioplasty (PCA). The Sparrow® self-expanding drug-eluting stent, which has a lower profile than the current systems, has never been tested in this scenario. Objectives To evaluate the late effectiveness of the Sparrow® drug-eluting stent, regarding in-stent late lumen loss (LLL). Methods Patients with ischemia, symptomatic or documented, were submitted to PCA in vessels with reference diameter < 2.75 mm, divided into two groups regarding Sparrow® stent type: group 1: Sparrow® drug-eluting stent (DES), group 2: Sparrow® bare metal stent (BMS). Clinical follow-up duration was 12 months. Evaluation using quantitative coronary angiography (QCA) was performed immediately and at 8 months. A decrease of over 65% of in-stent LLL with DES was estimated to calculate sample size. IBM® SPSS software, release 19 (Chicago, Illinois, USA) was used for the statistical analysis. Results A total of 24 patients were randomized, 12 in each group. The DES and BMS groups were similar in age (63.25 ± 10.01 vs. 64.58 ± 11.54, p = 0.765), male gender (58.3% vs. 33.3%, p = 0.412), risk factors and all angiographs aspects. Immediate results were satisfactory in both groups. At 8 months in-stent late lumen loss was significantly lower in DES than in BMS group (DES vs. BMS 0.25 ± 0.16 0.97 ± 0.76, p = 0.008). Conclusion In small-vessel PCA, the Sparrow® DES determined significant reduction in in-stent LLL, when compared to Sparrow® BMS. PMID:24100691

  15. Fracture and Collapse of Balloon-Expandable Stents in the Bilateral Common Iliac Arteries Due to Shiatsu Massage

    SciTech Connect

    Ichihashi, Shigeo Higashiura, Wataru; Itoh, Hirofumi; Sakaguchi, Shoji; Kichikawa, Kimihiko

    2012-12-15

    We report a case of stent fracture and collapse of balloon-expandable stents caused by shiatsu massage. A 76-year-old man presented with complaints of intermittent claudication of the right lower extremity. Stenoses of the bilateral common iliac arteries (CIAs) were detected. Balloon-expandable stents were deployed in both CIAs, resulting in resolution of symptoms. Five months later, pelvis x-ray showed collapse of both stents. Despite the stent collapse, the patient was asymptomatic, and his ankle brachial index values were within the normal range. Further history showed that the patient underwent daily shiatsu therapy in the umbilical region, which may have triggered collapse of the stent. Physicians should advise patients to avoid compression of the abdominal wall after implantation of a stent in the iliac artery.

  16. Bare metal stent versus paclitaxel eluting stent for intermediate length femoropopliteal arterial lesions (BATTLE trial): study protocol for a randomized controlled trial.

    PubMed

    Gouëffic, Yann; Kaladji, Adrien; Guyomarch, Béatrice; Montagne, Carine; Fairier, Damien; Gestin, Simon; Riche, Valéry-Pierre; Vent, Pierre Alexandre; Chaillou, Philippe; Costargent, Alain; Patra, Philippe

    2014-10-30

    Currently, endovascular treatment is indicated to treat femoropopliteal lesions ≤15 cm. However, the Achilles' heel of femoropopliteal endovascular repair remains restenosis. Paclitaxel eluting stents have shown promising results to prevent restenosis in femoropopliteal lesions compared to percutaneous transluminal angioplasty. A recently released prospective registry using a newer generation of self-expandable nitinol stents (Misago®; Terumo Corp., Tokyo, Japan) supports primary bare metal stenting as a first-line treatment for femoropopliteal lesions. To date, no studies have been designed to compare bare metal stents to paclitaxel eluting stents for the treatment of femoropoliteal lesions. The BATTLE trial was designed to compare paclitaxel eluting stents (Zilver® PTX®) and a last generation bare self-expandable nitinol stents (Misago® RX, Terumo Corp., Tokyo, Japan) in the treatment of intermediate length femoropopliteal lesions (≤14 cm). A prospective, randomized (1:1), controlled, multicentric and international study has been designed. One hundred and eighty-six patients fulfilling the inclusion criteria will be randomized to one of the two assessments of endovascular repair to treat de novo femoropopliteal lesions ≤14 cm in symptomatic patients (Rutherford 2 to 5): bare stent group and paclitaxel eluting stent group. The primary endpoint is freedom from in-stent restenosis at 1 year defined by a peak systolic velocity index >2.4 (restenosis of >50%) at the target lesion and assessed by duplex scan. Our main objective is to demonstrate the clinical superiority of primary stenting using Zilver® PTX® stent system versus bare metal self-expandable stenting in the treatment of femoropopliteal lesions in patients with symptomatic peripheral arterial disease. This is the first randomized and controlled study to compare the efficacy of bare metal stents and paclitaxel eluting stents for the treatment of femoropopliteal lesions. It may clarify the

  17. Covered Self-Expanding Transhepatic Biliary Stents:Clinical Pilot Study

    SciTech Connect

    Thurnher, Siegfried A.; Lammer, Johannes; Thurnher, Majda M.; Winkelbauer, Friedrich; Graf, Oswald; Wildling, Reinhard

    1996-11-15

    Purpose: We report our preliminary results with a new type of self-expanding covered stent for treatment of malignant biliary obstruction. Methods: Wallstents, fully covered with high elasticity polyurethane, with an unconstrained diameter of 10 mm and a total length of 69 mm, were placed transhepatically under fluoroscopic guidance in five patients. The length of the biliary obstruction varied between 30<+>-<+>50 mm. At 1 and 3 months (82<+>-<+>98 days) clinical assessment, serum bilirubin measurement, and ultrasound examination of the biliary tree were performed. Results: Initial uncomplicated deployment of the stents and internal drainage was possible in all patients. Distal stent migration resulted in early biliary reobstruction in one patient. At 3-month follow-up, partial reobstruction, most probably due to sludge formation, was found in another patient. Conclusion: Our initial results indicate that the covered, self-expanding Wallstent endoprosthesis can be reliably and safely deployed transhepatically for malignant biliary obstruction.

  18. Comparison of Drug-eluting Coronary Stents, Bare Coronary Stents and Self-expanding Stents in Angioplasty of Middle Cerebral Artery Stenoses

    PubMed Central

    Lee, Jong-Hyeog; Jo, Sung-Min; Jo, Kwang-Deog; Kim, Moon-Kyu; Lee, Sang-Youl

    2013-01-01

    Objective The purpose of this study is to investigate the results of treatment using stent-angioplasty for symptomatic middle cerebral arterial (MCA) stenosis and comparison of in-stent restenosis between drug-eluting stents (DES), bare metal coronary stents (BMS) and self-expanding stents (SES). Materials and Methods From Jan. 2007 to June. 2012, 34 patients (mean age ± standard deviation: 62.9 ± 13.6 years) with MCA stenosis were treated. Inclusion criteria were acute infarction or transient ischemic attacks (TIAs) and angiographically proven symptom related severe stenosis. Stents used for treatment were DES (n = 8), BMS (n = 13) and SES (n = 13). National Institutes of Health Stroke Scale (NIHSS) at admission was 2.5 ± 3.1 and mean stenosis rate was 79.0 ± 8.2%. Assessment of clinical and angiographic results was performed retrospectively. Results Among 34 patients, periprocedural complications occurred in four cases (11.8%), however, only two cases (6.0%) were symptomatic. All patients were followed clinically (mean follow-up period; 40.7 ± 17.7 months) and 31 were followed angiographically (91.2%. 13.4 ± 8.5 months). There was no occurrence of repeat stroke in all patients; however, mild TIAs related to restenosis occurred in three of 34 patients (8.8%). The mean NIHSS after stent-angioplasty was 1.7 ± 2.9 and 0.8 ± 1.1 at discharge. The modified Rankin score (mRS) at discharge was 0.5 ± 0.9 and 0.3 ± 0.8 at the last clinical follow-up. In-stent restenosis over 50% occurred in five of 31 angiographically followed cases (16.1%), however, all of these events occurred only in patients who were treated with BMS or SES. Restenosis rate was 0.0% in the DES group and 20.8% in the other group (p = 0.562); it did not differ between BMS and SES (2/11 18.2%, 3/13 23.1%, p = 1.000). Conclusion Stent-angioplasty appears to be effective for symptomatic MCA stenosis. As for restenosis, in our study, DES was presumed to be more effective than BMS and SES; meanwhile

  19. 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

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

    PubMed

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

    2015-10-01

    BACKGROUND⁄ 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. 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. 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. 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.

  1. Self-Expandable Metal Stenting of Refractory Upper Gut Corrosive Strictures: A New Role for Endoscopy?

    PubMed Central

    Manta, Raffaele; Conigliaro, Rita; Bertani, Helga; Manno, Mauro; Soliman, Ahmed; Fedeli, Paolo; Bassotti, Gabrio

    2011-01-01

    Caustic strictures of the gastrointestinal tract are often difficult to treat, since relapses are frequent after medical or endoscopic treatment. Thus, novel approaches are needed. We report here our experience with self-expandable metallic stents (SEMS) as a new endoscopic approach in three patients with corrosive strictures of the upper gastrointestinal tract. PMID:22606415

  2. Cholecystoduodenal Fistula: A Complication of Inserted Self-Expandable Metallic Biliary Stents

    SciTech Connect

    Nishida, Hirotoshi; Inoue, Hiroki; Ueno, Kazuto; Nagata, Yukitaka; Kato, Takeshi; Miyazono, Nobuaki; Nakajo, Masayuki

    1998-05-15

    We encountered a case of hepatic hilar cholangiocarcinoma resulting in cholecystoduodenal fistula after insertion of self-expandable metallic biliary stents (EMBSs). To our knowledge, there has been no report of cholecystoduodenal fistula after insertion of EMBSs. This case suggests that immediate gallbladder decompression may be necessary if acute cholecystitis occurs after insertion of EMBSs.

  3. Cholecystoduodenal fistula: A complication of inserted self-expandable metallic bilitary stents

    SciTech Connect

    Nishida, Hirotoshi; Inoue, Hiroki; Ueno, Kazuto; Nagata, Yukitaka; Kato, Takeshi; Miyazono, Nobuaki; Nakajo, Masayuki

    1998-05-15

    We encountered a case of hepatic hilar cholangiocarcinoma resulting in cholecystoduodenal fistula after insertion of self-expandable metallic biliary stents (EMBSs). To our knowledge, there has been no report of cholecystoduodenal fistula after insertion of EMBSs. This case suggests that immediate gallbladder decompression may be necessary if acute cholecystitis occurs after insertion of EMBSs.

  4. Clinical effect of double coaxial self-expandable metallic stent in management of malignant colon obstruction

    PubMed Central

    Won, Yoodong; Lee, Su Lim; Ku, Young Mi; Kim, Ki Tae; Won, Hye Sung; An, Chang Hyeok

    2015-01-01

    PURPOSE We aimed to evaluate the clinical effectiveness and safety of double coaxial self-expandable metallic stent (DCSEMS) in management of malignant colonic obstruction as a bridge to surgery or palliation for inoperable patients. METHODS Between April 2006 and December 2012, 49 patients (27 males and 22 females; median age, 68 years; age range, 38–91 years) were selected to receive decompressive therapy for malignant colonic obstruction by implanting a DCSEMS. Application of DCSEMS was attempted in 49 patients under fluoroscopic guidance. The obstruction was located in the transverse colon (n=2), descending colon (n=7), sigmoid colon (n=24), rectosigmoid junction (n=6), and the rectum (n=10). The intended use of DCSEMS was as a bridge to elective surgery in 23 patients and palliation in 26 patients. RESULTS Clinical success, defined as >50% dilatation of the stent with subsequent symptomatic improvement, was achieved in 48 of 49 patients (98%). The stent was properly inserted in all patients. No immediate major procedure-related complications occurred. One patient in the bridge-to-surgery group had colon perforation three days after DCSEMS application. Four patients had late migrations of the double stent. CONCLUSION Application of DCSEMS is safe and effective in management of malignant colonic obstruction; it prevents stent migration and tumor ingrowth and lowers perforation rate during the stent application. PMID:25698096

  5. 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.

  6. Self-expandable metal stents for malignant gastric outlet obstruction: A pooled analysis of prospective literature

    PubMed Central

    van Halsema, Emo E; Rauws, Erik AJ; Fockens, Paul; van Hooft, Jeanin E

    2015-01-01

    AIM: To provide an overview of the clinical outcomes of self-expandable metal stent (SEMS) placement for malignant gastric outlet obstruction (MGOO). METHODS: A systematic literature search was performed in PubMed of the literature published between January 2009 and March 2015. Only prospective studies that reported on the clinical success of stent placement for MGOO were included. The primary endpoint was clinical success, defined according to the definition used in the original article. Data were pooled and analyzed using descriptive statistics. Subgroup analyses were performed for partially covered SEMSs (PCSEMSs) and uncovered SEMSs (UCSEMSs) using Fisher’s exact test. RESULTS: A total of 19 studies, including 1281 patients, were included in the final analysis. Gastric (42%) and pancreatic (37%) cancer were the main causes of MGOO. UCSEMSs were used in 76% of patients and PCSEMSs in 24%. The overall pooled technical success rate was 97.3% and the clinical success rate was 85.7%. Stent dysfunction occurred in 19.6% of patients, mainly caused by re-obstruction (12.6%) and stent migration (4.3%), and was comparable between PCSEMSs and UCSEMSs (21.2% vs 19.1%, respectively, P = 0.412). Re-obstruction was more common with UCSEMSs (14.9% vs 5.1%, P < 0.001) and stent migration was more frequent after PCSEMS placement (10.9% vs 2.2%, P < 0.001). The overall perforation rate was 1.2%. Bleeding was reported in 4.1% of patients, including major bleeding in 0.8%. The median stent patency ranged from 68 to 307 d in five studies. The median overall survival ranged from 49 to 183 d in 13 studies. CONCLUSION: The clinical outcomes in this large population showed that enteral stent placement was feasible, effective and safe. Therefore, stent placement is a valid treatment option for the palliation of MGOO. PMID:26604654

  7. Self-expandable metallic stents for palliative treatment of digestive cancer.

    PubMed

    Lopes, César Vivian; Pesenti, Christian; Bories, Erwan; Caillol, Fabrice; Giovannini, Marc

    2008-10-01

    BACKGROUND/GOAL: Self-expandable metallic stents can be used to reestablish luminal continuity in patients with malignancy of the esophagus, gastric outlet, or colon who are at high risk for surgical intervention. Data regarding their complication profiles remain incomplete. Our aim was to evaluate the feasibility and complications of endoscopic stenting in esophageal, gastroduodenal, and colonic malignancies. Between January 2003 and December 2005, 153 patients underwent 182 endoscopic procedures for insertion of 199 metallic stents in a single referral center. Complications were assessed retrospectively. The mean follow-up was 170 days. The mortality was 73.9% (113 patients), 105 cases between 1 and 60 weeks after the procedure (median survival, 17 wk), but none directly related to the stent placement. One single stent was required in 115 (75%) patients, and 37 (24.2%) cases required an overlapping stent. The procedure was unsuccessful in only 1 case of colonic obstruction. Thirty-eight (26.6%) patients developed 52 complications, of which 16 (9.4%) procedure-related complications (perforation, 5; migration, 5; obstruction, 3; misplacement, 2; and hemorrhage, 1) and 36 (21.3%) late complications (obstruction, 20; migration, 9; fistula, 6; and perforation, 1). Eight (5.6%) patients experienced more than 1 complication. Five (3.5%) cases required surgery (colon: 2 perforations, 1 fistula, and 1 obstruction; esophagus: 1 perforation). No significant difference on the complication rates was found for any site in which a metallic stent was inserted. Endoscopic stenting for palliation of digestive cancer, despite a reasonable complication rate, is feasible in most patients. Most dysfunctions are not life-threatening and can be managed endoscopically.

  8. Hemodynamic analysis of edge stenosis in peripheral artery stent grafts.

    PubMed

    Al-Hakim, R; Lee, E W; Kee, S T; Seals, K; Varghese, B; Chien, A; Quirk, M; McWilliams, J

    2017-10-01

    The purpose of this study was to characterize the hemodynamics of peripheral artery stent grafts to guide intelligent stent redesign. Two surgically explanted porcine arteries were mounted in an ex vivo system with subsequent deployment of an Xpert self-expanding nitinol stent or Viabahn stent graft. The arteries were casted with radiopaque resin, and the cast then scanned using micro-computed tomography at 8μm isotropic voxel resolution. The arterial lumen was segmented and a computational mesh grid surface generated. Computational fluid dynamics (CFD) analysis was subsequently performed using COMSOL Multiphysics 5.1. CFD analysis demonstrated low endothelial shear stress (ESS) involving 9.4 and 63.6% surface area of the central stent graft and bare metal stent, respectively. Recirculation zones were identified adjacent to the bare metal stent struts, while none were identified in the central stent graft. However, the stent graft demonstrated malapposition of the proximal stent graft edge with low velocity flow between the PTFE lining and arterial wall, which was associated with longitudinally and radially oriented recirculation zones and low ESS. Computational hemodynamic analysis demonstrates that peripheral artery stent grafts have a superior central hemodynamic profile compared to bare metal stents. Stents grafts, however, suffer from malapposition at the proximal stent edge which is likely a major contributor to edge stenosis. Copyright © 2017 Editions françaises de radiologie. Published by Elsevier Masson SAS. All rights reserved.

  9. A Newly Designed Nitinol Stent: Early Clinical Experience in the Treatment of Iliac Artery Stenoses and Occlusions

    PubMed Central

    Yoon, Chang Jin; Chung, Jin Wook; Hong, Soon Hyung; Song, Soon Young; Lim, Hyung Gehn; Lee, Yoon Sin

    2001-01-01

    Objective To investigate the effectiveness of the newly designed Niti-S stent in the management of iliac arterial stenoses and occlusions. Materials and Methods Stenoses (n=25) or occlusions (n=5) in the iliac arteries of 25 patients (30 limbs) were treated. The site of the lesions was the common (n=15) or external (n=11) iliac artery, or both (n=4). Eight limbs were treated for diffuse disease, six for highly eccentric lesion, five for occlusive lesion, and 11 for failed angioplasty. Results In all patients, technical success was achieved without major complications. One death, not procedure-related, occurred within 30 days. Ankle-brachial indexes improved from 0.63±0.30 to 0.99±0.21, and ischemic symptoms showed improvement in 22 patients (88%). Fontaine classifications before stenting, namely IIa(n=3), IIb(n=16), III(n=2), and IV(n=4) improved to I(n=17), IIa(n=5), and IV(n=3). Follow-up over a 27 (mean, 19.8±8)-month period showed that cumulative patency rates were 95.8% at 1 year and 86.2% at 2 and 3 years. No significant decrease in the mean ankle-brachial index was observed. Conclusion The Niti-S stent appears to be a safe and effective device for the treatment of iliac stenoses and occlusions. These preliminary results require confirmation with a larger series. PMID:11752985

  10. Short-term stenting using fully covered self-expandable metal stents for treatment of refractory biliary leaks, postsphincterotomy bleeding, and perforations.

    PubMed

    Canena, Jorge; Liberato, Manuel; Horta, David; Romão, Carlos; Coutinho, António

    2013-01-01

    Fully covered self-expandable metal stents (FCSEMS) have been used as a rescue therapy for several benign biliary tract conditions (BBC). Long-term stent placement commonly occurs, and prolonged FCSEMS placement is associated with the majority of the complications reported. This study evaluated the duration of stenting and the efficacy and safety of temporary FCSEMS placement for three BBCs: refractory biliary leaks, postsphincterotomy bleeding, and perforations. This was a retrospective case series with long-term follow-up of 25 patients who underwent FCSEMS placement for BBCs. This study included 17 patients with postcholecystectomy refractory biliary leaks who had previously undergone unsuccessful sphincterotomy and plastic stent placement, 4 patients with difficult-to-control postsphincterotomy bleeding, and 4 patients with a perforation following endoscopic sphincterotomy. Stents were removed according to clinical evidence of problem resolution. The review included stenting duration, safe FCSEMS removal, clinical efficacy, complications, and long-term outcomes. During the follow-up period, ERCP and cholangioscopy procedures were performed to exclude the possibility of bile duct lesion development. Complete resolution of the initial condition was achieved in all patients. Patients with biliary leaks had a median stent duration time of 16 days (range 7-28 days). Patients with bleeding had stents removed after a median time of 6 days (range 3-15 days). Patients with perforations had their stents removed after a median time of 29.5 days (range 21-30 days). There were no complications related to stenting. Temporary placement of a FCSEMS for 30 days or less is an effective rescue therapy for refractory biliary leaks, difficult-to-control post-endoscopic sphincterotomy bleeding, and perforations. Duration of stenting should be different for each type of condition. Stents can be safely removed, and short-term stenting is associated with the absence of early and late

  11. Comparison of Endoscopic Vacuum Therapy and Endoscopic Stent Implantation With Self-Expandable Metal Stent in Treating Postsurgical Gastroesophageal Leakage

    PubMed Central

    Hwang, Jae J.; Jeong, Yeon S.; Park, Young S.; Yoon, Hyuk; Shin, Cheol M.; Kim, Nayoung; Lee, Dong H.

    2016-01-01

    Abstract The aim of the present study was to evaluate the more effective therapy for the postsurgical gastroesophageal leakage by a head-to-head comparison of endoscopic vacuum therapy (EVT) and endoscopic stent implantation with self-expandable metal stent (E-SEMS). In this hospital-based, retrospective, observative study, the patients were classified into 2 groups. Those treated with EVT were assigned to the EVT group (n = 7), and those treated with E-SMS were assigned to the E-SEMS group (n = 11). We evaluated the clinical characteristics and treatment outcomes between the 2 groups. All 7 patients (100%) were treated with EVT, but only 7 of 11 patients (63.6%) in the stenting group were treated successfully. The median time to clinical success was 19.5 (5–21) days in the EVT group and 27.0 (3–84) days in the E-SEMS group. The median hospital stay was 37.1 (13–128) days in the EVT group and 87.3 (17–366) days in the E-SEMS group. The complicaion rate was lower in the EVT group (0/7, 0.0%) than that in the E-SEMS group (6/11, 54.5%) with statistically significant difference (P = 0.042). EVT is more effective and has fewer adverse effects than E-SMS therapy as a treatment for postsurgical gastroesophageal leakage. PMID:27100431

  12. Comparison of Endoscopic Vacuum Therapy and Endoscopic Stent Implantation With Self-Expandable Metal Stent in Treating Postsurgical Gastroesophageal Leakage.

    PubMed

    Hwang, Jae J; Jeong, Yeon S; Park, Young S; Yoon, Hyuk; Shin, Cheol M; Kim, Nayoung; Lee, Dong H

    2016-04-01

    The aim of the present study was to evaluate the more effective therapy for the postsurgical gastroesophageal leakage by a head-to-head comparison of endoscopic vacuum therapy (EVT) and endoscopic stent implantation with self-expandable metal stent (E-SEMS). In this hospital-based, retrospective, observative study, the patients were classified into 2 groups. Those treated with EVT were assigned to the EVT group (n = 7), and those treated with E-SMS were assigned to the E-SEMS group (n = 11). We evaluated the clinical characteristics and treatment outcomes between the 2 groups. All 7 patients (100%) were treated with EVT, but only 7 of 11 patients (63.6%) in the stenting group were treated successfully. The median time to clinical success was 19.5 (5-21) days in the EVT group and 27.0 (3-84) days in the E-SEMS group. The median hospital stay was 37.1 (13-128) days in the EVT group and 87.3 (17-366) days in the E-SEMS group. The complicaion rate was lower in the EVT group (0/7, 0.0%) than that in the E-SEMS group (6/11, 54.5%) with statistically significant difference (P = 0.042). EVT is more effective and has fewer adverse effects than E-SMS therapy as a treatment for postsurgical gastroesophageal leakage.

  13. 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

    2017-07-19

    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.

  14. Safety and efficacy of self-expandable metallic stents in malignant small bowel obstructions

    PubMed Central

    Tsuboi, Akiyoshi; Kuwai, Toshio; Nishimura, Tomoyuki; Iio, Sumio; Mori, Takeshi; Imagawa, Hiroki; Yamaguchi, Toshiki; Yamaguchi, Atsushi; Kouno, Hirotaka; Kohno, Hiroshi

    2016-01-01

    In this report, we present 3 cases of malignant small bowel obstruction, treated with palliative care using endoscopic self-expandable metallic stent (SEMS) placement, with the aim to identify the safety and efficacy of this procedure. Baseline patient characteristics, procedure methods, procedure time, technical and clinical success rates, complications, and patient outcomes were obtained. All 3 patients had pancreatic cancer with small bowel strictures. One patient received the SEMS using colonoscopy, while the other 2 patients received SEMS placement via double balloon endoscopy using the through-the-overtube technique. The median procedure time was 104 min. The technical and clinical success rates were 100%. Post-treatment, obstructive symptoms in all patients improved, and a low-residue diet could be tolerated. All stents remained within the patients until their deaths. The median overall survival time (stent patency time) was 76 d. SEMS placement is safe and effective as a palliative treatment for malignant small bowel obstruction. PMID:27833393

  15. The United States StuDy for EvalUating EndovasculaR TreAtments of Lesions in the Superficial Femoral Artery and Proximal Popliteal By usIng the Protégé EverfLex NitInol STent SYstem II (DURABILITY II).

    PubMed

    Matsumura, Jon S; Yamanouchi, Dai; Goldstein, Jeffrey A; Pollock, Christopher W; Bosiers, Marc; Schultz, Greg A; Scheinert, Dierk; Rocha-Singh, Krishna J

    2013-07-01

    Angioplasty and stenting are options for revascularization of symptomatic femoral popliteal disease. Although angioplasty alone is effective in short lesions, longer lesions are often treated with stents. Multiple overlapping stents are expensive and may be associated with stent fracture. This trial evaluated the safety and efficacy of a single self-expanding stent up to 20 cm in length in patients with atherosclerotic disease of the superficial femoral artery (SFA) and proximal popliteal artery. Patients with lesions >4 cm and <18 cm were enrolled in this nonrandomized, prospective, multicenter trial that evaluated the Protégé EverFlex Self-Expanding Peripheral Stent System (Covidien, Plymouth, Minn). The study's primary end points were the 30-day major adverse event rate and duplex ultrasound-assessed patency at 1 year. These were compared with published performance goals. A preplanned analysis was conducted for the primary effectiveness end points at 1 year. Follow-up, including history, ankle-brachial index, patient-reported outcomes, duplex ultrasound assessment, and radiographs, is planned through 3 years. There was core laboratory review of angiograms, ultrasound scans, and plain radiographs. A subgroup of patients was studied with graded treadmill testing. The study enrolled 287 patients (66% male; mean age, 68 years) with stenotic, restenotic, or occluded lesions of the SFA at 44 investigational sites in the United States and Europe. Systemic comorbidities included hypertension (88%), hyperlipidemia (86%), diabetes (43%), and prior SFA intervention (41%). The mean lesion length measured by the core laboratory was 89 mm. The mean normal-to-normal lesion length measured by sites was 110 mm. A total of 303 stents were implanted, and 95% of patients received a single stent. No major adverse events occurred at 30 days. At 1 year, primary outcome of duplex ultrasound stent patency was 67.7% in evaluable patients, and among 1-year secondary outcomes, the mean

  16. Small caliber covered self-expanding metal stents in the management of malignant dysphagia

    PubMed Central

    Kucera, Stephen; Barthel, James; Klapman, Jason; Shridhar, Ravi; Hoffe, Sarah; Harris, Cynthia; Almhanna, Khaldoun

    2016-01-01

    Background Use of large caliber [≥18 mm body diameter (BD)] self-expanding metal stents (SEMS) for management of malignant dysphasia is associated with substantial adverse event (AE) and mortality rates (MRs). We sought to determine dysphagia response, stent migration rates, and AE and MRs, for small caliber covered SEMS (sccSEMS) with BDs between 10–16 mm in malignant dysphagia. Methods Thirty-one patients underwent direct endoscopic placement of 50 sccSEMS between January 2008 and March 2011. Patients were monitored for change in dysphagia score (DS), stent migration, AEs, and death through May 2011. Results DS improved in 30 of 31 patients (97%). The median DS decreased from 3 to 2 (P<0.0001). The median effective duration of first sccSEMS placement was 116 (95% CI: 75–196) days. Major and minor AE rates were 6.5% and 19.4% respectively. No stent related deaths were encountered. The overall migration rate was 36% (18/50). The anticipated migration rate was 45.7% (16/35) and the unanticipated migration rate was 13.3% (2/15) (P=0.052). Positive effective clinical outcome occurred in 93.5% (29/31) of cases. Conclusions In malignant dysphagia, direct endoscopic sccSEMS placement provided acceptable dysphagia control and migration rates with substantial reductions in stent related AEs and MRs compared to those reported for large caliber SEMS. PMID:27284474

  17. Finite element analysis of balloon-expandable coronary stent deployment: influence of angioplasty balloon configuration.

    PubMed

    Martin, David; Boyle, Fergal

    2013-11-01

    Today, the majority of coronary stents are balloon-expandable and are deployed using a balloon-tipped catheter. To improve deliverability, the membrane of the angioplasty balloon is typically folded about the catheter in a pleated configuration. As such, the deployment of the angioplasty balloon is governed by the material properties of the balloon membrane, its folded configuration and its attachment to the catheter. Despite this observation, however, an optimum strategy for modelling the configuration of the angioplasty balloon in finite element studies of coronary stent deployment has not been identified, and idealised models of the angioplasty balloon are commonly employed in the literature. These idealised models often neglect complex geometrical features, such as the folded configuration of the balloon membrane and its attachment to the catheter, which may have a significant influence on the deployment of a stent. In this study, three increasingly sophisticated models of a typical semi-compliant angioplasty balloon were employed to determine the influence of angioplasty balloon configuration on the deployment of a stent. The results of this study indicate that angioplasty balloon configuration has a significant influence on both the transient behaviour of the stent and its impact on the mechanical environment of the coronary artery.

  18. Pre-Clinical Testing of a Novel Thin Film Nitinol Flow Diversion Stent in a Rabbit Elastase Aneurysm Model

    PubMed Central

    Ding, YongHong; Dai, Daying; Kallmes, David F.; Schroeder, Dana; Kealey, Colin P.; Gupta, Vikas; Johnson, A. David; Kadirvel, Ramanathan

    2015-01-01

    Purpose Thin Film Nitinol (TFN) can be processed to produce a thin microporous sheet with low percent metal coverage (<20%) and high pore density (~70 pores/mm2) for flow diversion. We present in vivo results from treatment of experimental rabbit aneurysms using a TFN-based flow diversion device. Materials and Methods Nineteen aneurysms in the rabbit elastase aneurysm model were treated with a single TFN flow diverter. Devices were also placed over 17 lumbar arteries to model peri-aneurysmal branch arteries of the intracranial circulation. Angiography was performed at 2 weeks (n=7), 1 month (n=8) and 3 months (n=4) immediately before sacrifice. Aneurysm occlusion was graded on a 3-point scale (Grade 1, complete occlusion; Grade 2, near-complete occlusion; Grade 3, incomplete occlusion). Toluidine blue staining was used for histologic evaluation. En face CD31 immunofluorescent staining was performed to quantify neck endothelialization. Results Markedly reduced intra-aneurysmal flow was observed on angiography immediately after device placement in all aneurysms. Grade 1 or 2 occlusion was noted in four (57%) aneurysms at 2-week, in six (75%) aneurysms at 4-week and in three (75%) aneurysms at 12-week follow-up. All 17 lumbar arteries were patent. CD31 staining showed that 75 ± 16% of the aneurysm neck region was endothelialized. Histopathology demonstrated incorporation of the TFN flow diverter into the vessel wall and no evidence of excessive neointimal hyperplasia. Conclusion In this rabbit model, the TFN flow diverter achieved high rates of aneurysm occlusion and promoted tissue in-growth and aneurysm neck healing, even early after implantation. PMID:26494695

  19. [Endoscopic palliation of malignant esophagus processes using a self-expanding metallic stent].

    PubMed

    Binek, J; Eigenmann, F; Hammer, B

    1995-04-15

    We investigated the palliative effect of self-expanding metallic stents on malignant obstruction of the esophagus in 10 patients. All patients had high grade dysphagia and one had an esophago-bronchial fistula. Endoscopic insertions of the prosthesis was done under sedation. Dilatation of the stricture prior to insertion was rarely necessary. Coated stents were used as secondary treatment for patients with fistulae. The procedure related morbidity was low and no mortality was observed. The stents remained patent during the residual lifetime of the patients. Dislocation or perforation did not occur. The median survival of 8 deceased patients was 3.5 months (range 1.25-14.5 months). At present 2 patients are still alive 2.7 and 1.5 months after the procedure. Self-expanding stents in the esophagus provide good palliative therapy of dysphagia or fistulae caused by malignant tumors. Insertion is relatively simple and safer than in nonexpandable types. These improvements may justify the considerably higher price of these devices.

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

    NASA Astrophysics Data System (ADS)

    Balachandar, Gowra; Trowers, Eugene A.

    2000-05-01

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

  1. Long-Term Results after Placement of Aortic Bifurcation Self-Expanding Stents: 10 Year Mortality, Stent Restenosis, and Distal Disease Progression

    SciTech Connect

    Houston, J. Graeme Bhat, Raj; Ross, Rose; Stonebridge, Peter A.

    2007-02-15

    Purpose. To retrospectively evaluate the 10 year follow-up results in patients who had 'kissing' self-expanding stent aortic bifurcation reconstruction. Methods. Forty-three patients were treated with 'kissing' self-expanding stents for aortoiliac occlusive disease. Early follow-up with clinical and ankle brachial pressure indices (ABPI) was performed at 3, 6, 12, and 24 months and with intra-arterial digital subtraction angiography at 12-24 months; clinical and angiographic follow-up was performed for symptom recurrence up to 10 years after treatment. Retrospective record review was performed to assess mortality, clinical patency, angiographic patency, and secondary assisted patency of both stents and downstream peripheral vessels at 5 and 10 years follow-up. Results. The 2 year primary angiographic and secondary assisted stent patencies were 89% and 93%, respectively. At 10 years follow-up in 40 patients the mortality was 38% (due to myocardial infarction, stroke, chronic renal failure, malignancy, and liver failure). At 5 and 10 years follow-up the primary clinical stent patency was 82% and 68%, and the secondary assisted stent patency 93% and 86%, respectively. At 5 and 10 years, the distal vessel patency was 86% and 72%, and the secondary assisted distal vessel patency treated by surgical or endovascular techniques was 94% and 88%, respectively. At 10 years there was no limb loss. Conclusion. The long-term (10 year) results of aortic bifurcation arterial self-expanding stent placement in patients with arterial occlusive disease show a 10 year primary stent patency rate of 68% but a secondary assisted patency rate of 86%. In addition there is a high overall mortality due to other cardiovascular causes and the rate of distal disease progression and loss of patency is similar to the loss of stent patency rate.

  2. [The use of intravascular nitinol stents in the treatment of subclavian vein compression for thoracic outlet syndrome].

    PubMed

    Pupka, Artur; Szyber, Przemysław P; Garcarek, Jerzy; Szyber, Piotr

    2007-01-01

    The purpose of this study is to evaluate the multimodal treatment (thrombolysis, anticoagulation and surgical decompression) of subclavian-axillary vein thrombosis (Paget-Schroetter syndrome) and possibility of shortening of time of therapy. In this paper 23 patients with Paget-Schroetter syndrome in Department of Vascular, General and Transplantological Surgery is presented. Thrombolysis with rt-PA, anticoagulation with heparin and intra venous angioplasty with the use intravascular stent, and operation with resection of the first rib in the treatment of subclavian vein thrombosis was used. During the follow up period the patients were divided into two groups: group I (13 patients) with traditional surgical decompression after 3-4 months (potential risk of hemorage) and group II (10 patients) with early surgical treatment (median 8 days). Long-term follow-up was obtained by chart review and asking patients to complete the DASH (Disabilities of the Arm, Shoulder and Hand) questionnaire that was developed by the American Academy of Orthopedic Surgeons. Complete revascularization with venous thrombolysis was achived in all patients. Decompresion with transaxillary resection of first rib and venous revascularization were performed in the same procedure in all patients. Statistical difference were not found in both groups. Most patients report no disability of upper limb at work and sport activity. Multimodal treatment of Paget-Schroetter syndrome (thrombolysis, the use of intravascular stents and early thoracic outlet decompression) can be used as a optimal of therapeutic method to subclavian vein thrombosis. The advantages of immediate surgical treatment are a promotion of rapid resumption of athletic activities.

  3. Use of fully covered self-expanding metal stents for the management of benign biliary conditions.

    PubMed

    García-Cano, J; Taberna-Arana, L; Jimeno-Ayllón, C; Martínez-Fernández, R; Serrano-Sánchez, L; Reyes-Guevara, A K; Viñuelas-Chicano, M; Gómez-Ruiz, C J; Morillas-Ariño, M J; Pérez-García, J I; Pérez-Vigara, G; Pérez-Sola, A

    2010-09-01

    biliary self-expanding metal stents (SEMS) have the advantage of being inserted undeployed with very small sizes and provide, when fully opened, large diameters for biliary drainage. However, their use in benign conditions has been very limited, mainly because of difficulty in their extraction. We present our initial experience with a fully covered SEMS (Wallflex) for the management of benign problems of the bile duct. in a prospective study, stents of 8 mm in diameter and 4, 6 or 8 cm long were inserted by means of ERCP. These SEMS were chosen when according to medical judgement it was thought that diameters greater than 10 French (3.3 mm) were needed for proper biliary drainage. Stents were extracted also endoscopically, several months later when deemed clinically appropriate. twenty biliary SEMS were inserted. Reasons for insertion were: large intrahepatic biliary fistula after hydatid cyst surgery (1), perforation of the papillary area following endoscopic sphincterotomy (2), coaxial insertion to achieve patency in obstructed uncovered stents inserted in benign conditions (3), benign strictures (7), multiple and large common bile duct stones that could not be extracted because of tapering and stricturing of the distal common bile duct (7). In all cases, successful biliary drainage was achieved and there were no complications from insertion. Stents were easily extracted after a mean time of 132 days (36-270) in place. Complete resolution of biliary problems was obtained in 14 patients (70%). in our initial experience, the fully covered Wallflex biliary stent was removed without any complication after being in place in the common bile duct for a mean time of over four months. Therefore, it could be used in the management of benign biliary conditions.

  4. Biliary self-expandable metal stents do not adversely affect pancreaticoduodenectomy.

    PubMed

    Cavell, Lianne K; Allen, Peter J; Vinoya, Cjloe; Eaton, Anne A; Gonen, Mithat; Gerdes, Hans; Mendelsohn, Robin B; D'Angelica, Michael I; Kingham, T Peter; Fong, Yuman; Dematteo, Ronald; Jarnagin, William R; Kurtz, Robert C; Schattner, Mark A

    2013-07-01

    Controversy exists regarding whether to place a plastic or a metal endobiliary stent in patients with resectable pancreatic cancer who require biliary drainage. Although self-expandable metal stents (SEMS) provide better drainage compared with plastic stents, concerns remain that SEMS may compromise resection and increase postoperative complications. Our objective was to compare surgical outcomes of patients undergoing pancreaticoduodenectomy (PD) with SEMS in place vs. plastic endoscopic stents (PES) and no stents (NS). We performed a retrospective analysis from a prospective database of all patients undergoing either attempted or successful PD with SEMS, PES, or NS in place at the time of operation. Patients were compared with regard to perioperative complications, margin status, and the rate of intraoperative determination of unresectability. A total of 593 patients underwent attempted PD. Of these, 84 patients were locally unresectable intraoperatively and 509 underwent successful PD, of which 71 had SEMS, 149 had PES, and 289 had NS. Among patients who had a preoperative stent, SEMS did not increase overall or serious postoperative complications, 30-day mortality, length of stay, biliary anastomotic leak, or positive margin, but was associated with more wound infections and longer operative times. In those with adenocarcinoma, intraoperative determination of local unresectability was similar in the SEMS group compared with other groups, with 16 (19.3%) in SEMS compared with 29 (17.7%) in PES (P=0.862), and 31 (17.5%) in NS (P=0.732). Placement of SEMS is not contraindicated in patients with resectable pancreatic cancer who require preoperative biliary drainage.

  5. Palliation of malignant esophageal obstruction and fistulas with self expandable metallic stents

    PubMed Central

    Dobrucali, Ahmet; Caglar, Erkan

    2010-01-01

    AIM: To evaluate the efficacy of self expandable metallic stents (SEMS) in patients with malignant esophageal obstruction and fistulas. METHODS: SEMS were implanted in the presence of fluoroscopic guidance in patients suffering from advanced and non-resectable esophageal, cardiac and invasive lung cancer between 2002 and 2009. All procedures were performed under conscious sedation. All patients had esophagus obstruction and/or fistula. In all patients who required reintervention, recurrence of dysphagia, hemorrhage, and fistula formation were indications for further endoscopy. Patients’ files were scanned retrospectively and the obtained data were analyzed using SPSS 13.0 for Windows. The χ2 test was used for categorical data and was analysis of variance for non-categorical data. Patients’ long-term survival was assessed using the Kaplan-Meier method. RESULTS: Stents were successfully implanted in 90 patients using fluoroscopic guidance. Reasons for stent implantation in these patients were esophageal stricture (77/90, 85.5%), external pressure (8/90, 8.8%) and tracheo-esophageal fistula (5/90, 5.5%). Dysphagia scores (mean ± SD) were 3.37 ± 0.52 before and 0.90 ± 0.43 after stent implantation (P = 0.002). Intermittent, non-massive hemorrhage due to the erosion caused by the distal end of the stent in the stomach occurred in only one patient who received implementation at cardio-esophageal junction. Mean survival following stenting was 134.14 d (95% confidence interval: 94.06-174.21). CONCLUSION: SEMS placement is safe and effective in the palliation of dysphagia in selected patients with malignant esophageal strictures. PMID:21128325

  6. Hepatic venous outflow obstruction after transplantation: outcomes for treatment with self-expanding stents.

    PubMed

    Viteri-Ramírez, G; Alonso-Burgos, A; Simon-Yarza, I; Rotellar, F; Herrero, J I; Bilbao, J I

    2015-01-01

    To evaluate the safety and patency of self-expanding stents to treat hepatic venous outflow obstruction after orthotopic liver transplantation. To evaluate differences in the response between patients with early obstruction and patients with late obstruction. This is a retrospective analysis of 16 patients with hepatic venous outflow obstruction after liver transplantation treated with stents (1996-2011). Follow-up included venography/manometry, ultrasonography, CT, and laboratory tests. We did a descriptive statistical analysis of the survival of patients and stents, technical and clinical success of the procedure, recurrence of obstruction, and complications of the procedure. We also did an inferential statistical analysis of the differences between patients with early and late obstruction. The mean follow-up period was 3.34 years (21-5,331 days). The technical success rate was 93.7%, and the clinical success rate was 81.2%. The rate of complications was 25%. The survival rates were 87.5% for patients and 92.5% for stents. The rate of recurrence was 12.5%. The rate of primary patency was 0.96 (95% CI 0.91-1) at 3 months, 0.96 (95% CI 0.91-1) at 6 months, 0.87 (95% CI 0.73-1) at 12 months, and 0.87 (95% CI 0.73-1) at 60 months. There were no significant differences between patients with early and late obstruction, although there was a trend toward higher rates of primary patency in patients with early obstruction (P=.091). Treating hepatic venous outflow obstruction after orthotopic transplantation with self-expanding stents is effective, durable, and effective. There are no significant differences between patients with early obstruction and those with late obstruction. Copyright © 2013 SERAM. Published by Elsevier España, S.L.U. All rights reserved.

  7. Successful technical and clinical outcome using a second generation balloon expandable coronary stent for transplant renal artery stenosis: Our experience

    PubMed Central

    Salsamendi, Jason; Pereira, Keith; Baker, Reginald; Bhatia, Shivank S; Narayanan, Govindarajan

    2015-01-01

    Transplant renal artery stenosis (TRAS) is a vascular complication frequently seen because of increase in the number of renal transplantations. Early diagnosis and management is essential to optimize a proper graft function. Currently, the endovascular treatment of TRAS using angioplasty and/or stenting is considered the treatment of choice with the advantage that it does not preclude subsequent surgical correction. Treatment of TRAS with the use of stents, particularly in tortuous transplant renal anatomy presents a unique challenge to an interventional radiologist. In this study, we present three cases from our practice highlighting the use of a balloon-expandable Multi-Link RX Ultra coronary stent system (Abbott Laboratories, Abbott Park, Illinois, USA) for treating high grade focal stenosis along very tortuous renal arterial segments. Cobalt–Chromium alloy stent scaffold provides excellent radial force, whereas the flexible stent design conforms to the vessel course allowing for optimal stent alignment. PMID:26629289

  8. Endosonography-guided drainage of malignant fluid collections using lumen-apposing, fully covered self-expanding metal stents.

    PubMed

    Musumba, Crispin; Tutticci, Nicholas; Nanda, Kavinderjit; Kwan, Vu

    2014-08-01

    Endosonography (EUS)-guided drainage of paragastric fluid collections using fully covered self-expanding metal stents (FCSEMS) is now a well-established procedure. Recently, new and specially designed lumen-apposing, fully-covered metal cystgastrostomy stents have been employed for this indication. In this case series, the use of these new stents for the drainage of malignant fluid collections in three symptomatic patients is described. Cases included a large pancreatic pseudocyst, secondary to underlying acute lymphoblastic leukemia, and two large collections of loculated ascites due to metastatic ovarian and cervical cancer, respectively. Technical success in inserting the new stents was achieved in all three patients, and resulted in symptomatic relief. There were no clinically significant complications directly attributed to the stents. These new lumen-apposing cystgastrostomy stents may provide a viable, minimally invasive, and effective alternative for drainage of malignant fluid collections, either for definitive treatment or for palliation of symptoms.

  9. Plastic prosthesis versus expandable metal stents for palliation of inoperable esophageal thoracic carcinoma: a controlled prospective study.

    PubMed

    De Palma, G D; di Matteo, E; Romano, G; Fimmano, A; Rondinone, G; Catanzano, C

    1996-05-01

    Rapid palliation of malignant dysphagia is usually possible with endoscopic implantation of a plastic prosthesis, but this device has a high rate of complications. Recently, expandable metal stents, a new class of endoprosthesis, have become available and may reduce complication rates. Thirty nine patients affected by esophageal thoracic cancer were randomly assigned to treatment with either a plastic stent (20 patients) or expandable metal stent (19 patients). The degree of palliation (expressed as dysphagia score) and incidence of complications (short- and long-term) were compared in both treatment groups. Technical success, as a percentage of successful intubation, was similar in both treatment groups (90% vs 94.7%, p = NS) and dysphagia scores improved significantly and similarly in both treatment groups. Nevertheless, complications and mortality related to implantation were significantly less frequent with metal stents than with plastic prostheses (complications: 0% vs 21%, p < 0.001; mortality: 0% vs. 15.8%, p < 0.001). Late complications included obstruction by food in both treatment groups (four cases with plastic stents vs four cases with metal stents), tube migration only with plastic prostheses (two cases) and tumor ingrowth only with metal stents (two cases). Expandable metal stents can be considered an effective and safer alternative to conventional plastic prostheses in the treatment of esophageal obstruction caused by inoperable cancer.

  10. Combined Placement of Covered Self-Expanding Metallic Stents and Nasojejunal Tube for Managing Large Lower Esophageal Perforations.

    PubMed

    Rana, Surinder S; Gupta, Rajesh; Dahiya, Divya; Behera, Arunanshu; Bhasin, Deepak K

    2014-02-01

    Covered self-expanding metallic stents (cSEMSs) have emerged as effective treatment option for esophageal perforations. However, the large lower esophageal perforations where the cSEMS is placed across gastroesophageal junction have lower healing rates because refluxed gastric contents constantly irritate perforation and also there is increased risk of stent migration. Moreover, gastric mucosa tends to prolapse into lumen of lower end of stent causing its obstruction, leading to seepage of saliva and fluids from upper end of stent even in the patients who are on parenteral nutrition. We present our experience of a novel technique of combined cSEMS and nasojejunal tube (NJT) placement in four patients (two males) with benign large lower esophageal perforations. The NJT was placed through the stent into the jejunum through which patients were given enteral feeding. The stents were placed 5 - 21 days after esophageal perforation with the size of perforation ranging from 4 to 6 cm. As the NJT formed a loop in stomach, it prevented migration of stent. And also its presence in lumen of stent prevented its obstruction by prolapsing gastric mucosa, thereby preventing seepage of saliva and fluids from side of stent. Both stents and NJT were removed after 6 weeks and leak closed in all patients. Combined cSEMS and NJT placement seems to be safe and effective for treating large lower esophageal perforations. NJT placement seems to decrease risk of migration, prevents seepage of fluids and permits early enteral nutrition, thereby improving the healing rates.

  11. Combined Placement of Covered Self-Expanding Metallic Stents and Nasojejunal Tube for Managing Large Lower Esophageal Perforations

    PubMed Central

    Rana, Surinder S; Gupta, Rajesh; Dahiya, Divya; Behera, Arunanshu; Bhasin, Deepak K

    2014-01-01

    Covered self-expanding metallic stents (cSEMSs) have emerged as effective treatment option for esophageal perforations. However, the large lower esophageal perforations where the cSEMS is placed across gastroesophageal junction have lower healing rates because refluxed gastric contents constantly irritate perforation and also there is increased risk of stent migration. Moreover, gastric mucosa tends to prolapse into lumen of lower end of stent causing its obstruction, leading to seepage of saliva and fluids from upper end of stent even in the patients who are on parenteral nutrition. We present our experience of a novel technique of combined cSEMS and nasojejunal tube (NJT) placement in four patients (two males) with benign large lower esophageal perforations. The NJT was placed through the stent into the jejunum through which patients were given enteral feeding. The stents were placed 5 - 21 days after esophageal perforation with the size of perforation ranging from 4 to 6 cm. As the NJT formed a loop in stomach, it prevented migration of stent. And also its presence in lumen of stent prevented its obstruction by prolapsing gastric mucosa, thereby preventing seepage of saliva and fluids from side of stent. Both stents and NJT were removed after 6 weeks and leak closed in all patients. Combined cSEMS and NJT placement seems to be safe and effective for treating large lower esophageal perforations. NJT placement seems to decrease risk of migration, prevents seepage of fluids and permits early enteral nutrition, thereby improving the healing rates. PMID:27785265

  12. Mechanical Interaction of an Expanding Coiled Stent with a Plaque-Containing Arterial Wall: A Finite Element Analysis.

    PubMed

    Welch, Tré R; Eberhart, Robert C; Banerjee, Subhash; Chuong, Cheng-Jen

    2016-03-01

    Wall injury is observed during stent expansion within atherosclerotic arteries, related in part to stimulation of the inflammatory process. Wall stress and strain induced by stent expansion can be closely examined by finite element analysis (FEA), thus shedding light on procedure-induced sources of inflammation. The purpose of this work was to use FEA to examine the interaction of a coiled polymer stent with a plaque-containing arterial wall during stent expansion. An asymmetric fibrotic plaque-containing arterial wall model was created from intravascular ultrasound (IVUS) images of a diseased artery. A 3D model for a coil stent at unexpanded state was generated in SolidWorks. They were imported into ANSYS for FEA of combined stent expansion and fibrotic plaque-distortion. We simulated the stent expansion in the plaqued lumen by increasing balloon pressure from 0 to 12 atm in 1 atm step. At increasing pressure, we examined how the expanding stent exerts forces on the fibrotic plaque and vascular wall components, and how the latter collectively resist and balance the expansive forces from the stent. Results show the expanding coiled stent creates high stresses within the plaque and the surrounding fibrotic capsule. Lower stresses were observed in adjacent medial and adventitial layers. High principal strains were observed in plaque and fibrotic capsule. The results suggest fibrotic capsule rupture might occur at localized regions. The FEA/IVUS method can be adapted for routine examination of the effects of the expansion of selected furled stents against IVUS-reconstructed diseased vessels, to improve stent deployment practices.

  13. Clinical outcome of simultaneous self-expandable metal stents for palliation of malignant biliary and duodenal obstruction.

    PubMed

    Kaw, M; Singh, S; Gagneja, H

    2003-03-01

    Previous studies have shown that self-expanding metal stents are an effective method for palliation of malignant biliary or duodenal obstruction. We present our experience with the use of simultaneous self-expandable metal stents for palliation of malignant biliary and duodenal obstruction. We performed a retrospective review of all patients undergoing simultaneous biliary and duodenal self-expandable metal stent placement between November 98 and May 2001. All the patients had documented evidence of biliary obstruction and symptomatic duodenal obstruction. The patients received endoscopic biliary stenting with biliary Ultraflex or Wallstents, and endoscopic duodenal stenting using enteral Wallstents. They were followed until their death. We identified 18 patients (11 men and 7 women) whose mean age was 65 years, (range, 46-85 years). Malignancies included pancreatic 14 (78%), biliary 2 (11%), lymphoma 1 (5%), and metastatic 1 (5%) disorders. Ten patients previously had plastic biliary stents placed for past malignant biliary obstruction (4 patients had recurrent biliary obstruction). All the patients had evidence of duodenal obstruction. Combined metal stenting was successful in 17 patients. One procedure failed due to a tortuous duodenal stricture. All the patients had effective palliation of biliary obstruction, as evidenced by a decrease in the level of total bilirubin and alkaline phosphatase. Of the 17 patients with successful duodenal stenting, 16 had a good clinical outcome, with relief of obstructive symptoms. No immediate stent-related complications were noted. During the follow-up period, 12 patients died of progression of the underlying malignancy. None of the deaths were stent related. Median survival time was 78 days. Two patients had recurrent biliary obstruction from tumor ingrowth at 45 and 68 days, respectively. Both underwent restenting: one by endoscopic retrograde cholangiopancreatography (ERCP) and the other by percutaneous transhepatic

  14. Vascular stents: Coupling full 3-D with reduced-order structural models

    NASA Astrophysics Data System (ADS)

    Avdeev, I.; Shams, M.

    2010-06-01

    Self-expanding nitinol stents are used to treat peripheral arterial disease. The peripheral arteries are subjected to a combination of mechanical forces such as compression, torsion, bending, and contraction. Most commercially available peripheral self-expanding stents are composed of a series of sub-millimeter V-shaped struts, which are laser-cut from a nitinol tube and surface-treated for better fatigue performance. The numerical stent models must accurately predict location and distribution of local stresses and strains caused by large arterial deformations. Full 3-D finite element non-linear analysis of an entire stent is computationally expensive to the point of being prohibitive, especially for longer stents. Reduced-order models based on beam or shell elements are fairly accurate in capturing global deformations, but are not very helpful in predicting stent failure. We propose a mixed approach that combines the full 3-D model and reduced-order models. Several global-local, full 3-D/reduced-order finite element models of a peripheral self-expanding stent were validated and compared with experimental data. The kinematic constraint method used to couple various elements together was found to be very efficient and easily applicable to commercial FEA codes. The proposed mixed models can be used to accurately predict stent failure based on realistic (patient-specific), non-linear kinematic behavior of peripheral arteries.

  15. Iliocaval Confluence Stenting for Chronic Venous Obstructions

    SciTech Connect

    Graaf, Rick de; Wolf, Mark de; Sailer, Anna M.; Laanen, Jorinde van Wittens, Cees; Jalaie, Houman

    2015-10-15

    PurposeDifferent techniques have been described for stenting of venous obstructions. We report our experience with two different confluence stenting techniques to treat chronic bi-iliocaval obstructions.Materials and MethodsBetween 11/2009 and 08/2014 we treated 40 patients for chronic total bi-iliocaval obstructions. Pre-operative magnetic resonance venography showed bilateral extensive post-thrombotic scarring in common and external iliac veins as well as obstruction of the inferior vena cava (IVC). Stenting of the IVC was performed with large self-expandable stents down to the level of the iliocaval confluence. To bridge the confluence, either self-expandable stents were placed inside the IVC stent (24 patients, SECS group) or high radial force balloon-expandable stents were placed at the same level (16 patients, BECS group). In both cases, bilateral iliac extensions were performed using nitinol stents.ResultsRecanalization was achieved for all patients. In 15 (38 %) patients, a hybrid procedure with endophlebectomy and arteriovenous fistula creation needed to be performed because of significant involvement of inflow vessels below the inguinal ligament. Mean follow-up was 443 ± 438 days (range 7–1683 days). For all patients, primary, assisted-primary, and secondary patency rate at 36 months were 70, 73, and 78 %, respectively. Twelve-month patency rates in the SECS group were 85, 85, and 95 % for primary, assisted-primary, and secondary patency. In the BECS group, primary patency was 100 % during a mean follow-up period of 134 ± 118 (range 29–337) days.ConclusionStenting of chronic bi-iliocaval obstruction shows relatively high patency rates at medium follow-up. Short-term patency seems to favor confluence stenting with balloon-expandable stents.

  16. Clinical outcomes of self-expandable stent placement for benign esophageal diseases: A pooled analysis of the literature

    PubMed Central

    van Halsema, Emo E; van Hooft, Jeanin E

    2015-01-01

    AIM: To analyze the outcomes of self-expandable stent placement for benign esophageal strictures and benign esophageal leaks in the literature. METHODS: The PubMed, Embase and Cochrane databases were searched for relevant articles published between January 2000 and July 2014. Eight prospective studies were identified that analyzed the outcomes of stent placement for refractory benign esophageal strictures. The outcomes of stent placement for benign esophageal leaks, perforations and fistulae were extracted from 20 retrospective studies that were published after the inclusion period of a recent systematic review. Data were pooled and analyzed using descriptive statistics. RESULTS: Fully covered self-expandable metal stents (FC SEMS) (n = 85), biodegradable (BD) stents (n = 77) and self-expandable plastic stents (SEPS) (n = 70) were inserted in 232 patients with refractory benign esophageal strictures. The overall clinical success rate was 24.2% and according to stent type 14.1% for FC SEMS, 32.9% for BD stents and 27.1% for SEPS. Stent migration occurred in 24.6% of cases. The overall complication rate was 31.0%, including major (17.7%) and minor (13.4%) complications. A total of 643 patients were treated with self-expandable stents mainly for postsurgical leaks (64.5%), iatrogenic perforations (19.6%), Boerhaave’s syndrome (7.8%) and fistulae (3.7%). FC SEMS and partially covered SEMS were used in the majority of patients. Successful closure of the defect was achieved in 76.8% of patients and according to etiology in 81.4% for postsurgical leaks, 86.0% for perforations and 64.7% for fistulae. The pooled stent migration rate was 16.5%. Stent-related complications occurred in 13.4% of patients, including major (7.8%) and minor (5.5%) complications. CONCLUSION: The outcomes of stent placement for refractory benign esophageal strictures were poor. However, randomized trials are needed to put this into perspective. The evidence on successful stent placement for benign

  17. A Comparative Biocompatibility Analysis of Ternary Nitinol Alloys

    PubMed Central

    Haider, Waseem; Munroe, Norman; Pulletikurthi, Chandan; Singh Gill, Puneet K.; Amruthaluri, Sushma

    2009-01-01

    Nitinol alloys are rapidly being utilized as the material of choice in a variety of applications in the medical industry. It has been used for self-expanding stents, graft support systems, and various other devices for minimally invasive interventional and endoscopic procedures. However, the biocompatibility of this alloy remains a concern to many practitioners in the industry due to nickel sensitivity experienced by many patients. In recent times, several new Nitinol alloys have been introduced with the addition of a ternary element. Nevertheless, there is still a dearth of information concerning the biocompatibility and corrosion resistance of these alloys. This study compared the biocompatibility of two ternary Nitinol alloys prepared by powder metallurgy (PM) and arc melting (AM) and critically assessed the influence of the ternary element. ASTM F 2129-08 cyclic polarization in vitro corrosion tests were conducted to evaluate the corrosion resistance in phosphate buffered saline (PBS). The growth of endothelial cells on NiTi was examined using optical microscopy. PMID:19956791

  18. Role of new sirolimus self-apposing stent in coronary interventions.

    PubMed

    Giustino, G; Mehran, R

    2015-02-01

    Device technology in interventional cardiology is continuously evolving. Self-expandable (SE) coronary artery stents were the first device to be implanted within a human coronary artery. However, because of their initial limitations, balloon-expandable (BE) stents were predominantly developed and used in the last 30 years. Unfortunately, in challenging anatomical settings such as bifurcation lesions, large, ectatic or aneurysmal vessels, tapered vessels or vasoconstricted arteries, outcomes with BE stents are not always optimal. The Stentys (Stentys SA, Paris, France) SE nitinol stents were initially developed for the treatment of coronary bifurcation lesions. The understanding of the underlying mechanism involved in incomplete stent apposition and subsequent stent thrombosis led to the introduction of self-apposing stents in the treatment of acute coronary syndrome in order to overcome the limitations of drug-eluting stents in presence of high thrombus burden. In this regard, Stentys allows a progressive stent expansion which could reduce the rates of incomplete stent apposition by conforming to vascular remodeling. Enhancing the advantages of this technology by adding the release of an antiproliferative drug to prevent restenosis is even more attractive and potentially effective. Recently, the results of the new Stentys sirolimus-eluting stent have been reported. This article provides an overview of the pathobiological rational, device characteristics and results of the new Stentys self-expandable sirolimus-eluting stent.

  19. A finite element study of balloon expandable stent for plaque and arterial wall vulnerability assessment

    NASA Astrophysics Data System (ADS)

    Karimi, Alireza; Navidbakhsh, Mahdi; Razaghi, Reza

    2014-07-01

    The stresses induced within plaque tissues and arterial layers during stent expansion inside an atherosclerotic artery can be exceeded from the yield stresses of those tissues and, consequently, lead to plaque or arterial layer rupture. The distribution and magnitude of the stresses in each component involved in stenting might be clearly different for different plaque types and different arterial layers. In this study, a nonlinear finite element simulation was employed to investigate the effect of plaque composition (calcified, cellular, and hypocellular) on the stresses induced in the arterial layers (intima, media, and adventitia) during implantation of a balloon expandable coronary stent into a stenosed artery. The atherosclerotic artery was assumed to consist of a plaque and normal/healthy arterial tissues on its outer side. The results indicated a significant influence of plaque types on the maximum stresses induced within the plaque wall and arterial layers during stenting but not when computing maximum stress on the stent. The stress on the stiffest calcified plaque wall was in the fracture level (2.38 MPa), whereas cellular and hypocellular plaques remain stable owing to less stress on their walls. Regardless of plaque types, the highest von Mises stresses were observed on the stiffest intima layer, whereas the lowest stresses were seen to be located in less stiff media layer. The computed stresses on the intima layer were found to be high enough to initiate a rupture in this stiff layer. These findings suggest a higher risk of arterial vascular injury for the intima layer, while a lower risk of arterial injury for the media and adventitia layers.

  20. Treatment of benign biliary leaks with transhepatic placement of coated self-expanding metallic stents.

    PubMed

    Páramo, M; García-Barquín, P; Carrillo, M; Millor Muruzábal, M; Vivas, I; Bilbao, J I

    To analyze the safety and efficacy of percutaneous placement of coated self-expanding metallic stents (SEMS) in patients with biliary leaks. This ethics committee at our center approved this study. We retrospectively reviewed all coated SEMS placed between October 2008 and September 2015. We analyzed patient-related factors such as the primary underlying disease, prior hepatic procedures, and clinical outcome. We evaluated the location, the number and type of leak (anastomotic or non-anastomotic), and the characteristics of the interventional procedure (number of stents deployed, location of the stents, technical success, and primary functionality). We recorded the complications registered. We studied 14 patients (11 men and 3 women). The mean follow-up period was 375.5 days (range 15-1920 days). Leaks were postsurgical in 12 patients. One patient developed an arteriobilioportal fistula. In another, the biliary leak occurred secondary to the rupture of the common bile duct after ERCP. A total of 23 coated SEMS were placed, including 21 Fluency(®) stents (Bard, Tempe, AZ, USA) and 2 Wallflex(®) stents (Boston Scientific, Galway, Republic of Ireland). The technical success of the procedure was considered total in 11 (78.6%) patients, partial in 2 (14.3%) patients, and null in 1 (7.2%) patient. The clinical outcome was good in 13 of the 14 patients. The mean period of primary functionality of the coated SEMS was 331 days (range 15-1920 days). No major complications were observed in 11 (78.6%) patients. Percutaneous placement of coated SEMS for the treatment of benign biliary leaks is safe and efficacious, with a high rate of technical and clinical success and a moderate rate of complications. Copyright © 2016 SERAM. Publicado por Elsevier España, S.L.U. All rights reserved.

  1. Use of Fully Covered Self-Expanding Metal Biliary Stents in Pediatrics: A Case Series.

    PubMed

    Mark, Jacob A; Mack, Cara L; Marwan, Ahmed I; Kramer, Robert E

    2017-08-23

    Endoscopic retrograde cholangiopancreatography (ERCP) is used to manage biliary pathology in pediatric patients. Plastic biliary stents have been utilized in this population for obstructive lesions and bile leaks, however they are sometimes not effective due to migration, occlusion, or ineffective sealing. Fully covered self-expanding metal stents (FCSEMS) have larger diameters making them more suitable for some situations. However, their use in pediatrics has not been defined. The aim of this study is to describe our experience with FCSEMS at our institution. We present a series of all patients who underwent FCSEMS placement at Children's Hospital Colorado including three adolescents and one young adult with complex medical needs. Patient age range was 12-24 years and the weight ranged between 36-75 kg. All patients underwent previous ERCP and one or more rounds of plastic stenting without adequate clinical response prior to consideration of FCSEMS placement. Indications included: 1) Recalcitrant biliary anastomotic stricture post liver transplant, 2) Persistent bile leak after needle perforation, 3) Recurrent obstructive choledocholithiasis after cholecystectomy, and 4) Malignant biliary stricture. Sizes of FCSEMS depended on patient bile duct size and biliary pathology. Dwell time was 6-8 weeks. Three patients had resolution of biliary pathology after FCSEMS therapy. One patient had distal migration of FCSEMS necessitating repeat stenting. There were no adverse events from FCSEMS placement or removal. FCSEMS therapy should be considered in appropriate pediatric patients when plastic biliary stents are not effective. Further studies are needed to evaluate the safety and efficacy of FCSEMS in the pediatric age group.

  2. Self-Expanding Metal Stenting in the Management of a Benign Colonic Stricture

    PubMed Central

    Jessamy, Kegan; Ozden, Nuri; Simon, Howard M.; Kobrossi, Semaan; Ubagharaji, Ezinnaya

    2016-01-01

    Colonic postanastomotic strictures occur in 1.5–8% of patients following colorectal surgery. Traditionally, colonic strictures were treated by multiple modalities including endoscopic dilatation. Self-expanding metal stents (SEMS) have been indicated in the management of benign colonic strictures; however, there are limited available data with regard to their efficacy. We present the case of a 68-year-old male who had perforated sigmoid diverticulitis followed by Hartmann's procedure with eventual reanastomosis 6 months later. He subsequently developed benign colonic stricture, which was treated with a metal stent. SEMS are associated with a low mortality rate and are appropriate in treating acute colonic obstruction as a result of benign stricture in the setting of postanastomosis. PMID:27403114

  3. Finite Element Modeling of A Novel Self-Expanding Endovascular Stent Method in Treatment of Aortic Aneurysms

    NASA Astrophysics Data System (ADS)

    Arokiaraj, Mark C.; Palacios, Igor F.

    2014-01-01

    A novel large self-expanding endovascular stent was designed with strut thickness of 70 μm × 70 μm width. The method was developed and investigated to identify a novel simpler technique in aortic aneurysm therapy. Stage 1 analysis was performed after deploying it in a virtual aneurysm model of 6 cm wide × 6 cm long fusiform hyper-elastic anisotropic design. At cell width of 9 mm, there was no buckling or migration of the stent at 180 Hg. Radial force of the stents was estimated after parametric variations. In stage 2 analysis, a prototype 300 μm × 150 μm stent with a cell width of 9 mm was chosen, and it was evaluated similarly after embedding in the aortic wall, and also with a tissue overgrowth of 1 mm over the stent. The 300/150 μm stent reduced the peak wall stress by 70% in the aneurysm and 50% reduction in compliance after embedding. Stage 3 analysis was performed to study the efficacy of stents with struts (thickness/width) 70/70, 180/100 and 300/150 μm after embedding and tissue overgrowth. The adjacent wall stresses were very minimal in stents with 180/100 and 70/70 μm struts after embedding. There is potential for a novel stent method in aortic aneurysm therapy.

  4. Impact of stent diameter on vascular response after self-expanding paclitaxel-eluting stent implantation in the superficial femoral artery.

    PubMed

    Miki, Kojiro; Fujii, Kenichi; Shibuya, Masahiko; Fukunaga, Masashi; Imanaka, Takahiro; Kawai, Kenji; Tamaru, Hiroto; Sumiyoshi, Akinori; Nishimura, Machiko; Horimatsu, Tetsuo; Saita, Ten; Yoshihara, Nagataka; Kimura, Takumi; Honda, Yasuhiro; Fitzgerald, Peter J; Masuyama, Tohru; Ishihara, Masaharu

    2017-10-01

    The optimal sizing of self-expanding paclitaxel-eluting stents (PES) in the treatment for superficial femoral artery (SFA) lesions is unclear. This study sought to investigate the influence of PES diameter on stent patency in SFA lesions using optical frequency domain imaging (OFDI). A total of 20 de novo SFA lesions were randomized 1:1 to receive either self-expanding PES with a nominal diameter of 6mm or 8mm. Follow-up angiography and OFDI was scheduled six months after stent implantation, and volumetric OFDI analysis was performed to evaluate vascular response to the stents. Volume index (VI) was defined as the volume divided by the stent length. The primary end point was lumen VI at the 6-month follow-up. Secondary end point was minimum lumen diameter (MLD) by quantitative vascular angiography (QVA) at the follow-up. Stent length was 78.0±23.9mm in the 6-mm group and 70.0±23.6mm in the 8-mm group (p=0.46). Baseline QVA data were also similar between the two groups. MLD immediately after stent implantation was similar between the two groups (4.2±0.5mm in the 6-mm group and 3.9±0.5mm in the 8-mm group, p=NS). At the 6-month follow-up, MLD was greater in the 8-mm group compared to the 6-mm group (4.0±1.0mm vs. 3.2±0.4mm, p<0.05). Stent VI was larger in the 8-mm group (28.4±6.7mm(3)/mm vs. 22.2±1.2mm(3)/mm, p=0.01). Neointimal VI was similar between the two groups (5.8±2.9mm(3)/mm vs. 5.2±2.6mm(3)/mm, p=0.68). Lumen VI was greater in the 8-mm group (23.2±7.6mm(3)/mm vs. 17.3±2.6mm(3)/mm, p=0.04). Chronic stent enlargement resulted in greater lumen area after implantation of self-expanding PES with a large diameter at the mid-term follow-up. Stent diameter might be important for stent patency in procedure with PES for SFA lesions. Copyright © 2017 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.

  5. The Results of Self-Expandable Kissing Stents in Aortic Bifurcation.

    PubMed

    Moon, Jae Young; Hwang, Hong Pil; Kwak, Hyo Sung; Han, Young Min; Yu, Hee Chul

    2015-03-01

    Kissing stent reconstruction is a widely used technique for the management of aortoiliac occlusive disease involving the aortic bifurcation or proximal common iliac arteries. The purpose of this study was to evaluate the results of self-expandable kissing stents in the aortic bifurcation. We reviewed medical records of the patients treated with a kissing stent retrospectively from January 2007 to December 2012. The primary and secondary patencies were determined with Kaplan-Meier analysis, and Cox regression was used to determine the factors associated with patency. A total of 21 patients were included, and all were male (median age 53±15 years, range 48-78 years). Major symptoms were claudication (n=16, 61.9%), rest pain (n=5, 23.8%) and gangrene (n=5, 23.8%). Tans-Atlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC) II classification was A 2 (9.5%), B 5 (23.8%), C 7 (33.3%) and D 8 (38%). The mean follow-up was 40.7 months. Major complication occurred in only one case which consisted of distal limb ischemia by emboli. Six patients developed symptomatic restenosis or occlusion. There was no major amputation, but minor amputation occurred in 3 patients. There were 2 mortalities not associated with the procedure (lung cancer and intracranial hemorrhage). Primary patency was 89.6% at 1 year, 74.7% at 3 years and 64.0% at 5 years. Secondary patency was 94.1% at 1 year, 88.2% at 3 years and 68.6% at 5 years. No risk factors for restenosis or occlusion were identified. Self-expandable kissing stents can be used successfully with comparable patency for endovascular treatment of symptomatic atherosclerotic occlusive lesions in the aortic bifurcation area.

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

    PubMed

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

    2015-01-01

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

  7. Percutaneous transhepatic self-expanding metal stents for palliation of malignant biliary obstruction.

    PubMed

    Lawson, A J; Beningfield, S J; Krige, J E J; Rischbieter, P; Burmeister, S

    2012-07-11

    Malignant biliary obstruction is often inoperable at presentation and has a poor prognosis. Percutaneously placed self-expanding metal stents (SEMS) have been widely used for palliation of malignant biliary obstruction as an alternative to major bypass surgery or when endoscopic drainage is not technically feasible. The success rate, procedural complications and outcomes in patients who underwent placement of SEMS in a tertiary referral centre are presented. All patients who had percutaneous transhepatic cholangiography (PTC) and SEMS for palliation of malignant biliary obstruction between May 2008 and July 2010 at Groote Schuur Hospital, Cape Town, were reviewed. A retrospective chart review was undertaken using multidisciplinary case notes of all patients. The data analysed included demographic information, diagnosis, level of biliary obstruction, number and type of procedures, efficacy and complications of SEMS insertion. Boston Scientific 69 mm by 10 mm Wallstent SEMS were used in all patients. RESULTS; Fifty patients (28 men, 22 women, mean age 61 years, range 48 - 80 years) underwent percutaneous SEMS placement. Twenty-one patients had biliary obstruction at the level of the hilum involving the hepatic duct bifurcation, 5 in the mid-common bile duct and 24 in the low common bile duct. In 20 patients (40%) SEMS were placed at the time of initial biliary drainage (one-stage procedure), while the remaining 30 patients underwent stent placement within 2 - 23 days of biliary drainage as a two-stage procedure because of difficult access through the lesion during the initial procedure. Five patients (10%) required bilateral SEMS insertion. Stent placement was successful in all patients and biliary obstruction was relieved in all. The mean serum bilirubin level decreased by a mean of 56% from 294 µmol/l to 129 µmol/l measured 5 days after stent insertion. Mean hospital stay after stent insertion was 4.1 days. The average length of hospital stay for patients who

  8. Understanding the Mechanical forces of Self-Expandable Metal Stents in the Biliary Ducts.

    PubMed

    Isayama, Hiroyuki; Nakai, Yousuke; Hamada, Tsuyoshi; Matsubara, Saburo; Kogure, Hirofumi; Koike, Kazuhiko

    2016-12-01

    Self-expandable metallic stent (SEMS) was an effective biliary endoprosthesis. Mechanical properties of SEMS, radial and axial force (RF, AF), may play important roles in the bile duct after placement. RF was well known dilation force and influenced on the occurrence of migration. AF, newly proposed by this author, was defined as the recovery force when the SEMS vended. AF was related with the cause of bile duct kinking, pancreatitis, and cholecystitis due to the compression of the bile duct, orifice of the cystic duct, and pancreatic orifice. Ideal SEMS may show high RF and low AF.

  9. Complication rates using balloon-expandable and self-expanding stents for the treatment of intracranial atherosclerotic stenoses : analysis of the INTRASTENT multicentric registry.

    PubMed

    Kurre, Wiebke; Brassel, Friedhelm; Brüning, Roland; Buhk, Jan; Eckert, Bernd; Horner, Susanna; Knauth, Michael; Liebig, Thomas; Maskova, Jana; Mucha, Dirk; Sychra, Vojtech; Sitzer, Matthias; Sonnberger, Michael; Tietke, Marc; Trenkler, Johannes; Turowski, Bernd; Berkefeld, Joachim

    2012-01-01

    Using balloon-expandable stents (BES) for treatment of intracranial stenoses, high inflation pressures and rigidity of the device are regarded as major drawbacks limiting feasibility and safety of the procedure. Self-expanding stents (SES) were developed to facilitate lesion access and to allow for less aggressive dilatation. We analyzed data of the INTRASTENT multicentric registry to assess whether self-expanding stents significantly reduced peri-interventional complication rates. Records of intracranial stent procedures were entered consecutively into the registry. Datasets were divided into two groups according to the type of stent used. For outcome measurement, we chose three categories: TIA/minor stroke [modified Rankin score (mRS) <2], disabling stroke, and patient death. Clinical outcome was compared between BES and SES. We analyzed types of adverse events occurring in each group in addition. Of 409 atherosclerotic lesions, 254 were treated with BES and 155 with SES. Technical success rates were 97.6% and 98.7%, respectively. Adverse event rates were 4.9%, 3.7%, and 0.8% for TIA/nondisabling stroke, disabling stroke, and death in the BES group compared with 5.3%, 6.0%, and 4.0% in the SES group. The differences were not statistically significant. We observed more perforator strokes after use of BES, but thromboembolic events occurred more often in the SES treatment group. Data of the INTRASTENT registry do not support the hypothesis that introduction of SES lowered the overall complication rate of intracranial stent procedures. There might be an advantage using self-expanding stents in vessel segments with important perforating arteries.

  10. Use of fully covered self-expanding metal stents in benign biliary diseases

    PubMed Central

    García-Cano, Jesús

    2012-01-01

    Biliary fully covered self-expanding metal stents (FCSEMS) are now being used to treat several benign biliary conditions. Advantages include small predeployment and large postexpansion diameters in addition to an easy insertion technique. Lack of imbedding of the metal into the bile duct wall enables removability. In benign biliary strictures that usually require multiple procedures, despite the substantially higher cost of FCSEMS compared with plastic stents, the use of FCSEMS is offset by the reduced number of endoscopic retrograde cholangiopancreatography interventions required to achieve stricture resolution. In the same way, FCSEMS have also been employed to treat complex bile leaks, perforation and bleeding after endoscopic biliary sphincterotomy and as an aid to maintain permanent drainage tracts obtained by means of Endoscopic Ultrasound-guided biliary drainage. Good success rates have been achieved in all these conditions with an acceptable number of complications. FCSEMS were successfully removed in all patients. Comparative studies of FCSEMS and plastic stents are needed to demonstrate efficacy and cost-effectiveness PMID:22523615

  11. Preoperative Drainage for Malignant Biliary Strictures: Is It Time for Self-Expanding Metallic Stents?

    PubMed Central

    Roque, Jason; Ho, Shiaw-Hooi

    2015-01-01

    Palliation of jaundice improves the general health of the patient and, therefore, surgical outcomes. Because of the complexity and location of strictures, especially proximally, drainage has been accompanied by increased morbidity due to sepsis. Another concern is the provocation of an inflammatory and fibrotic reaction around the area of stent placement. Preoperative biliary drainage with self-expanding metallic stent (SEMS) insertion can be achieved via a percutaneous method or through endoscopic retrograde cholangiopancreatography. A recently published multicenter randomized Dutch study has shown increased morbidity with preoperative biliary drainage. A Cochrane meta-analysis has also shown a significantly increased complication rate with preoperative drainage. However, few of these studies have used a SEMS, which allows better biliary drainage. No randomized controlled trials have compared preoperative deployment of SEMS versus conventional plastic stents. The outcomes of biliary drainage also depend on the location of the obstruction, namely the difficulty with proximal compared to distal strictures. Pathophysiologically, palliation of jaundice will benefit all patients awaiting surgery. However, preoperative drainage often results in increased morbidity because of procedure-related sepsis. The use of SEMS may change the outcome of preoperative biliary drainage dramatically. PMID:25674520

  12. Cefotaxime-eluting covered self-expandable stents in a canine biliary model: scanning electron microscopic study of biofilm formation.

    PubMed

    Gwon, Dong Il; Lee, Sang Soo; Kim, Eun-Young

    2012-12-01

    As bacterial attachment and subsequent biofilm formation on the surface of a stent lumen may be important in initiating sludge formation and subsequent stent blockage, there is a need for antibiotic-eluting stents to prevent sludge formation by bacterial attachment and colonization. To evaluate the antimicrobial effects of cefotaxime-eluting covered self-expandable stents (CE-CSEMS) in a canine biliary model by using scanning electron microscopy (SEM) to analyze biofilm formation on the inner surface of the stents. Three 10% (wt/vol) CE-CSEMS, three 20% (wt/vol) CE-CSEMS, and three control stents (CS) were endoscopically inserted into the bile ducts of nine mongrel dogs, which were followed up for 8 weeks. Gross and SEM examinations were performed to access the development and degree of biofilm formation in dogs with CS and CE-CSEMS. All stents were successfully inserted into canine bile ducts without any procedure-related complications. All nine dogs remained in good health without jaundice over the next 8 weeks. The degree of biofilm was similar in dogs implanted with CS and CE-CSEMS using two concentrations of cefotaxime either by gross inspection or SEM. All stent types showed a similar biofilm structure with relatively uniform thickness on SEM. Cefotaxime does not prevent biofilm development in a canine biliary model. Biofilm formation on the inner surface of biliary stents may be prevented by using broad-spectrum antimicrobial agents and stents that maintain a steady release of these agents for a long time, thus prolonging stent patency.

  13. 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

  14. A fully covered self-expandable metal stent anchored by a 10-Fr double pigtail plastic stent: an effective anti-migration technique

    PubMed Central

    Katsinelos, Panagiotis; Lazaraki, Georgia; Gkagkalis, Stergios; Chatzimavroudis, Grigoris; Anastasiadou, Kiriaki; Georgakis, Nikos; Giouleme, Olga; Zavos, Christos; Kountouras, Jannis

    2017-01-01

    Background Fully covered self-expandable metal stents (FCSEMS) have been used successfully in the treatment of malignant and benign biliary strictures. However, stent migration is a major complication. We investigated the efficacy of anchoring FCSEMS with a 10-Fr double-pigtail plastic stent to prevent migration in patients with biliary strictures. Methods Between January 2012 and May 2013, 10 patients with malignant biliary strictures and one patient with a suprapapillary benign biliary stenosis were enrolled in the study. The primary endpoint of the study was to record the migration rate of FCSEMS. Results The placement of FCSEMSs and the anchoring with a 10-Fr double-pigtail plastic stent were successful in all patients. During a median follow-up period of eight months, proximal or distal migration of FCSEMS was not observed. No procedural complications related to the placement of FCSEMS and/or the anchoring plastic stent were recorded. Conclusions The placement of an anchoring 10-Fr double-pigtail stent is a simple and effective anti-migration technique for FCSEMS in patients with malignant biliary strictures. PMID:28042247

  15. Self-Expanding Metal Stent (SEMS): an innovative rescue therapy for refractory acute variceal bleeding.

    PubMed

    Changela, Kinesh; Ona, Mel A; Anand, Sury; Duddempudi, Sushil

    2014-12-01

    Acute variceal bleeding (AVB) is a life-threatening complication of liver cirrhosis or less commonly splenic vein thrombosis. Pharmacological and endoscopic interventions are cornerstones in the management of variceal bleeding but may fail in 10 - 15 % of patients. Rescue therapy with balloon tamponade (BT) or transjugular intrahepatic portosystemic shunt (TIPS) may be required to control refractory acute variceal bleeding effectively but with some limitations. The self-expanding metal stent (SEMS) is a covered, removable tool that can be deployed in the lower esophagus under endoscopic guidance as a rescue therapy to achieve hemostasis for refractory AVB. To evaluate the technical feasibility, efficacy, and safety of SEMS as a rescue therapy for AVB. In this review article, we have performed an extensive literature search summarizing case reports and case series describing SEMS as a rescue therapy for AVB. Indications, features, technique, deployment, success rate, limitations, and complications are discussed. At present, 103 cases have been described in the literature. Studies have reported 97.08 % technical success rates in deployment of SEMS. Most of the stents were intact for 4 - 14 days with no major complications reported. Stent extraction had a success rate of 100 %. Successful hemostasis was achieved in 96 % of cases with only 3.12 % found to have rebleeding after placement of SEMS. Stent migration, which was the most common complication, was observed in 21 % of patients. SEMS is a safe and effective alternative approach as a rescue therapy for refractory AVB.

  16. Prevention of Intracranial In-stent Restenoses: Predilatation with a Drug Eluting Balloon, Followed by the Deployment of a Self-Expanding Stent

    SciTech Connect

    Vajda, Zsolt Guethe, Thomas Perez, Marta Aguilar Kurre, Wiebke; Schmid, Elisabeth Baezner, Hansjoerg; Henkes, Hans

    2013-04-15

    Stenting in intracranial atherosclerotic disease (ICAD) is increasingly debated, due to issues of procedural safety, technical efficacy, and in-stent recurrent stenoses (ISR). In the present study, feasibility, safety, and efficacy of angioplasty using a drug-eluting balloon (DEB) followed by the implantation of a self-expanding stent (Enterprise) were evaluated for the treatment of ICAD lesions. Fifty-two patients (median age: 71 years; range: 54-86 years; male/female ratio 37:15) underwent stenting of high-grade ICAD lesions between February 2010 and November 2011 in a single center. Angioplasty using a paclitaxel coated SeQuent Please (B. Braun, Germany) or DIOR (Eurocor, Germany) coronary PTCA balloon, followed by the implantation of a self-expanding stent (Enterprise, Codman, USA) was performed in 54 lesions. Angiographic and clinical follow-up was performed at 6 and 12 weeks, 6 and 12 months, and yearly thereafter. Technical success rate, periprocedural complications, occurrence of recurrent ischemic symptoms, and the development of an ISR were analyzed. Angioplasty using a DEB followed by stent implantation was successfully performed in 44 (81 %) cases. DEB insertion failed in 19 % of the cases and angioplasty was finally performed using a conventional PTCA balloon. The combined procedure related permanent neurologic morbidity and mortality rate (stroke, ICH, and subarachnoid hemorrhage) at 30 days and beyond was 5 %. Angiographic and clinical follow-up were obtained in 33 (61 %) lesions in 32 patients. Recurrent stenosis was seen in one (3 %) lesion. Angioplasty and stenting using a DEB is safe and yields encouragingly low ISR rates. Further technical developments to improve lesion accessibility are, nevertheless, mandatory.

  17. 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.

  18. The varying porosity of braided self-expanding stents and flow diverters: an experimental study.

    PubMed

    Makoyeva, A; Bing, F; Darsaut, T E; Salazkin, I; Raymond, J

    2013-03-01

    Braided self-expandable stents and flow diverters of uniform construction may develop zones of heterogeneous porosity in vivo. Unwanted stenoses may also occur at the extremities of the device. We studied these phenomena in dedicated benchtop experiments. Five braided devices of decreasing porosity were studied. To simulate discrepancies in diameters between the landing zones of the parent vessel and the aneurysm neck area, device extremities were inserted into silicone tubes of various diameters (2-3 mm), leaving the midportion free to react to experimental manipulations, which included axial approximation of the tubes (0-7 mm), and curvature (0-135°), with or without axial compression (0-2 mm). The length of the landing zone was sequentially decreased to study terminal device stenosis. All devices adopted a conformation characterized by 3 different zones: bilateral landing zones, a middle compaction zone, and 2 transition zones. It is possible, during deployment, to compact stents and FDs to decrease porosity, but a limiting factor was the transition zone, which remained relatively unchanged and of higher porosity than the expansion zone. Length of the transition zone increased when devices were constrained in smaller tubes. Heterogeneities in porosity with compaction and curvatures were predictable and followed simple geometric rules. Extremity stenoses occurred increasingly with decreasing length of the landing zone. Braided self-expandable devices show predictable changes in porosity according to device size, vessel diameter, and curvature. Adequate landing zones are required to prevent terminal device stenosis.

  19. 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.

  20. The use of self-expanding silicone stents in esophageal cancer care: optimal pre-, peri-, and postoperative care.

    PubMed

    Martin, Robert; Duvall, Ryan; Ellis, Susan; Scoggins, Charles R

    2009-03-01

    Preoperative nutritional supplementation, management of esophageal leaks, and postoperative anastomotic strictures still remain common problems in the management of esophageal cancer. Jejunal feeding tubes, total parenteral nutrition (TPN) with nasogastric suction, and repeated esophageal dilations remain the most common treatments, respectively. The aim of this study was to evaluate the use of removable silicone stents in (1) the preoperative nutritional optimization during neoadjuvant therapy, (2) the management of perioperative anastomotic leak, and (3) the management of postoperative anastomotic strictures. Review of our prospectively maintained esophageal database identified 15 patients who had removable self-expanding silicone stents placed in the management of one of these three management problems from July 2004 to August 2006. Preoperative therapy: Five patients underwent initial stent placement in preparation for neoadjuvant therapy. Dysphagia relief was seen in 100% of patients, with optimal caloric needs taken within 24 h of placement. All patients tolerated neoadjuvant therapy without delay from dehydration or malnutrition. One stent migration was found at the time of operation, which was removed without sequelae. Perioperative therapy: Five patients developed delayed (>10 days) esophageal leaks that were managed with removable esophageal stent and percutaneous drainage (in three patients). All patients had successful exclusion of the leak on the day of the procedure with resumption of oral intake on the evening of procedure. All five healed leaks without sequelae. Postoperative therapy: Five patients developed postoperative anastomotic strictures that required dilation and placement of removable esophageal stent. The median number of dilations was 1 (range 1-2), with all stents placed for approximate 3 months duration. All patients had immediate dysphagia relief after stent placement. Removable esophageal stents are novel treatment option to optimize

  1. Self-expanding plastic stent removed after radiochemotherapy for advanced esophageal cancer.

    PubMed

    Laquière, A; Grandval, P; Heresbach, D; Prat, F; Arpurt, J P; Bichard, P; D'Halluin, P-N; Berthillier, J; Boustière, C; Laugier, R

    2014-01-01

    Endoscopic evaluation after chemoradiotherapy (CR) is impossible with an esophageal stent in place. The main study objective was to evaluate self-expanding plastic stent (SEPS) removal post-CR. Secondary end-points were the improvement of dysphagia and patients' quality of life. From October 2008 to March 2011, 20 dysphagic patients who suffered from advanced esophageal cancer were enrolled in a multicenter, prospective study. SEPS was inserted prior to CR and then removed endoscopically. SEPS efficiency (dysphagia score) and tolerance, as well as the patients' quality of life (European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire validated for the esophagus), were monitored. Continuous variables were compared using a paired t-test analysis for matched data. A P-value of less than 0.05 was considered statistically significant. Twenty patients (15 men and 5 women), aged 61.5 years (±9.88) (range 43-82 years), with adenocarcinoma (n = 12) and squamous cell carcinoma (n = 8), were enrolled. SEPS were successfully inserted in all patients (100%). There was one perforation and three episodes of migration. All of these complications were medically treated. The mean dysphagia score at the time of stent placement was 2.79 (0.6). Mean dysphagia scores obtained on day 1 and day 30 post-SEPS placement were 0.7 (0.9) (P < 0.0001) and 0.45 (0.8) (P < 0.0001), respectively. Quality of Life Questionnaire validated for the esophagus score showed an improvement in dysphagia (P = 0.01) and quality of oral feeding (P = 0.003). All SEPS were removed endoscopically without complications. In two patients, the stent was left in place due to metastatic disease. SEPS are extractable after CR of esophageal cancer. Early stenting by SEPS prior to and during CR may reduce dysphagia and improve quality of oral alimentation. © 2013 Wiley Periodicals, Inc. and the International Society for Diseases of the Esophagus.

  2. Arterial bleeding during EUS-guided pseudocyst drainage stopped by placement of a covered self-expandable metal stent

    PubMed Central

    2013-01-01

    Background Hemorrhagic complications during EUS-guided pseudocyst drainage can occur, because the vessels on the internal wall of the pseudocyst might be compressed by the fluid and thus not visible on color Doppler or even power Doppler EUS. Case presentation We report a case of an immediate internal spurting arterial bleeding precipitated during EUS-guided pseudocyst drainage which stopped instantaneously by placement of a double flanged covered self-expandable metal stent through mechanical hemostasis. Conclusion In an unusual situation of bleeding from collateral circulation near the pseudocyst wall during pseudocyst drainage, the placement of an expandable metal stent proved to be useful. PMID:23706101

  3. Determination of coefficient of friction for self-expanding stent-grafts.

    PubMed

    Vad, Siddharth; Eskinazi, Amanda; Corbett, Timothy; McGloughlin, Tim; Vande Geest, Jonathan P

    2010-12-01

    Migration of stent-grafts (SGs) after endovascular aneurysm repair of abdominal aortic aneurysms is a serious complication that may require secondary intervention. Experimental, analytical, and computational studies have been carried out in the past to understand the factors responsible for migration. In an experimental setting, it can be very challenging to correctly capture and understand the interaction between a SG and an artery. Quantities such as coefficient of friction (COF) and contact pressures that characterize this interaction are difficult to measure using an experimental approach. This behavior can be investigated with good accuracy using finite element modeling. Although finite element models are able to incorporate frictional behavior of SGs, the absence of reliable values of coefficient of friction make these simulations unreliable. The aim of this paper is to demonstrate a method for determining the coefficients of friction of a self-expanding endovascular stent-graft. The methodology is demonstrated by considering three commercially available self-expanding SGs, labeled as A, B, and C. The SGs were compressed, expanded, and pulled out of polymeric cylinders of varying diameters and the pullout force was recorded in each case. The SG geometries were recreated using computer-aided design modeling and the entire experiment was simulated in ABAQUS 6.8/STANDARD. An optimization procedure was carried out for each SG oversize configuration to determine the COF that generated a frictional force corresponding to that measured in the experiment. The experimental pullout force and analytically determined COF for SGs A, B, and C were in the range of 6-9 N, 3-12 N, and 3-9 N and 0.08-0.16, 0.22-0.46, and 0.012-0.018, respectively. The computational model predicted COFs in the range of 0.00025-0.0055, 0.025-0.07, and 0.00025-0.006 for SGs A, B, and C, respectively. Our results suggest that for SGs A and B, which are exoskeleton based devices, the pullout forces

  4. 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

  5. Novel characteristics of traction force in biliary self-expandable metallic stents.

    PubMed

    Hori, Yasuki; Hayashi, Kazuki; Yoshida, Michihiro; Naitoh, Itaru; Ban, Tesshin; Miyabe, Katsuyuki; Kondo, Hiromu; Nishi, Yuji; Umemura, Shuichiro; Fujita, Yasuaki; Natsume, Makoto; Kato, Akihisa; Ohara, Hirotaka; Joh, Takashi

    2017-05-01

    In recent years, knowledge concerning the mechanical properties of self-expandable metallic stents (SEMS) has increased. In a previous study, we defined traction force and traction momentum and reported that these characteristics are important for optimal stent deployment. However, traction force and traction momentum were represented as relative values and were not evaluated in various conditions. The purpose of the present study was to measure traction force in various situations assumed during SEMS placement. Traction force and traction momentum were measured in non-stricture, stricture, and angled stricture models using in-house equipment. Stricture and angled stricture models had significantly higher traction force and traction momentum than those of the non-stricture model (stricture vs non-stricture: traction force, 7.2 N vs 1.4 N, P < 0.001; traction momentum, 237.8 Ns vs 62.3 Ns, P = 0.001; angled stricture vs non-stricture: traction force, 7.4 N vs 1.4 N, P < 0.001; traction momentum, 307.2 Ns vs 62.3 Ns, P < 0.001). Traction force was variable during SEMS placement and was categorized into five different stages, which were similar in both the stricture and angled stricture models. We measured traction force and traction momentum under simulated clinical conditions and demonstrated that strictures and the angular positioning of the stent influenced the traction force. Clinicians should be aware of the transition of the traction force and should schedule X-ray imaging during SEMS placement. © 2017 Japan Gastroenterological Endoscopy Society.

  6. Partially covered self-expanding metal stent for unresectable malignant extrahepatic biliary obstruction: results of a large prospective series.

    PubMed

    Gómez-Oliva, Cristina; Guarner-Argente, Carlos; Concepción, Mar; Jiménez, Francisco Javier; Rodríguez, Sarbelio; Gonzalez-Huix, Ferran; Mugica, Fernando; Cabriada, José Luis; Rodríguez, Claudio; Aguilar, Carlos Guarner

    2012-01-01

    Endoscopic biliary stenting is a well-established palliative treatment in patients with unresectable malignant biliary strictures. Obstruction of uncovered self-expanding metal stent (SEMS) due to tumor ingrowth is the most frequent complication. Partially covered SEMS might increase stent patency but could favor complications related to stent covering, such as pancreatitis, cholecystitis, and migration. The aim of this study was to evaluate the efficacy and safety of partially covered SEMS in patients with an unresectable malignant biliary stricture. Patients with malignant extrahepatic biliary obstruction treated endoscopically with partially covered SEMS were included in this multicenter, prospective, nonrandomized study. One hundred ninety-nine patients were endoscopically treated with partially covered SEMS in 32 Spanish hospitals. Clinical success after deep cannulation was 96%. Early complications occurred in 4% (3 pancreatitis, 2 cholangitis, 1 hemorrhage, 1 perforation, and 1 cholecystitis). Late complications occurred in 19.5% (18 obstructions, 10 migrations, 6 cholangitis without obstruction, 3 acute cholecystitis, and 2 pancreatitis), with no tumor ingrowth in any case. Median stent patency was 138.9 ± 112.6 days. One-year actuarial probability of stent patency was 70% and that of nonmigration was 86%. Multivariate analysis showed adjuvant radio- or chemotherapy as the only independent predictive factor of stent patency and previous insertion of a biliary stent was the only predictive factor of migration. The partially covered SEMS was easily inserted, had a high clinical success rate, and prevented tumor ingrowth. The incidence of possible complications related to stent coverage, namely, migration, pancreatitis, and cholecystitis, was lower than in previously published series.

  7. New treatment of iliac artery disease: focus on the Absolute Pro® Vascular Self-Expanding Stent System

    PubMed Central

    Gates, Lindsay; Indes, Jeffrey

    2013-01-01

    Management of iliac artery disease has evolved over the years, from a surgical-only approach to a primarily endovascular-only approach as the first line treatment option. This has been continuously improved upon with the advent of new devices and applied technologies. Most recently in particular, the literature has shown good, reliable outcomes with the use of self-expandable stents in iliac artery atherosclerotic lesions. Nevertheless, no device is without its limitations, and the Absolute Pro® Vascular Self-Expanding Stent System was designed with the intent of overcoming some of the shortcomings of other available stents while maintaining acceptable postprocedural outcomes. Based on preliminary industry-acquired data, it has achieved these goals and appears to be an emergent competitor for the treatment of both focal and complex iliac artery lesions. PMID:24049463

  8. Multiple stent delivery system Multi-LOC, a new technology for spot-stenting of the femoropopliteal artery - proof of concept study in a preclinical large animal model.

    PubMed

    Sigl, Martin; Dudeck, Oliver; Jung, Johannes; Koelble, Heinz; Amendt, Klaus

    2017-08-21

    A new stent system was studied in a porcine model to evaluate its feasibility for spot-stenting of the femoropopliteal artery. In a preliminary study in a single pig, handling and mechanical features of the novel multiple stent delivery system were tested. The Multi-LOC system demonstrated great feasibility regarding its pushability, trackability, and crossability. Excellent visibility of the individual stents allowed exact anatomically controlled implantation. In our main study, four to five short Multi-LOC stents (13 mm long) were implanted into the femoropopliteal arteries of six domestic pigs and long (60 to 100 mm) self-expandable nitinol stents were implanted into the same target vessel contralaterally to allow for intraindividual comparison. After four weeks survival under dual antiplatelet treatment, control angiography was performed. The animals were euthanized, stented vessels were explanted, and histologic sections were examined for the presence of neointimal formation. Multi-LOC stents demonstrated no occlusion of the femoropopliteal axis (0 vs. 1 occlusion distal to a control stent), no stent fractures (0 out of 26 vs. 2 out of 6 control stents), and lower percentage diameter stenosis (0.564 ± 0.056 vs. 0.712 ± 0.089; p = 0.008) and length of stenosis (19.715 ± 5.225 vs. 39.397 ± 11.182; p = 0.007) compared to a standard control stent, which was similar in total length to the multiple stented artery segment. Histological examination confirmed myointimal hyperplasia underlying in-stent stenosis. The multiple stent delivery system was studied in a porcine model, which demonstrated its feasibility. Preclinical experience revealed favourable results concerning stent fracture, restenosis, and patency of spot-stented femoropopliteal arteries.

  9. Definitive outcomes of self-expandable metal stents in patients with refractory post-transplant biliary anastomotic stenosis.

    PubMed

    Tarantino, Ilaria; Barresi, Luca; Curcio, Gabriele; Granata, Antonino; Ligresti, Dario; Tuzzolino, Fabio; Volpes, Riccardo; Amata, Michele; Traina, Mario

    2015-07-01

    Endoscopic retrograde cholangio-pancreatography is the gold standard of treatment in patients with biliary complications after liver transplantation. The benefits of fully covered self-expandable metal stents (FCSEMS) lie in their relative simplicity and the need for only two procedures, one for insertion, and the other for removal. Several case series have been published on such stents with generally good outcomes. Objective is to analyze definitive long-term outcomes of this treatment. Prospective, observational study in a single, tertiary-care referral centre. All consecutive patients with post-transplant biliary stenosis/leak were treated with FCSEMS after failure of conventional treatment. Recurrence was evaluated after four years. From February 2008 to April 2012, 70 patients were included. In all patients, the metal stent was successfully placed. After a mean of 86.7 ± 38.4 days, the stent was removed. Forty-six patients (65.7%) showed resolution. After a mean of 4 ± 1.2 years, 61% of patients maintained the results, but 39% showed recurrence. On the tested variables the diagnosis of stenosis, the number of previous procedures and plastic stents placed correlate with better long-term results. This series suggests a lack of long-term advantages of FCSEMS over plastic stents in the management of biliary stenosis after liver transplantation. Copyright © 2015 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

  10. Self-expandable covered metal tracheal type stent for sealing cervical anastomotic leak after esophagectomy and gastric pull-up: pitfalls and possibilities.

    PubMed

    Lindenmann, Joerg; Matzi, Veronika; Porubsky, Christian; Anegg, Udo; Sankin, Oliver; Gabor, Sabine; Neuboeck, Nicole; Maier, Alfred; Smolle-Juettner, Freyja Maria

    2008-01-01

    From January 2003 to June 2006, 6 patients with leakage of the cervical esophagogastrostomy after esophagectomy and gastric pull-up underwent endoscopic stenting using the self-expandable covered tracheal type device. Anastomotic healing was satisfactory. Stent extraction was performed after an average interval of 91 days. Initial stent migration occurred in 2 patients and post-extraction stenosis developed in 3 patients. Insertion of a self-expandable covered metal tracheal stent represents a safe approach resulting in immediate closure and subsequent healing of cervical anastomotic leakage.

  11. Optimum palliation of inoperable hilar cholangiocarcinoma: comparative assessment of the efficacy of plastic and self-expanding metal stents.

    PubMed

    Raju, Ramu P; Jaganmohan, Sathya R; Ross, William A; Davila, Marta L; Javle, Milind; Raju, Gottumukkala S; Lee, Jeffrey H

    2011-05-01

    Endoscopic retrograde biliary drainage (ERBD) with plastic or self-expanding metal stents (SEMS) is often performed for palliative care for cholangiocarcinoma. The objective was to compare the clinical effectiveness, including stent patency, complication rate, and need for salvage percutaneous transhepatic biliary drainage, of SEMS and plastic stents. A total of 100 patients with inoperable cholangiocarcinoma were identified from an endoscopic database from 1/1/01 to 9/30/06 at a tertiary cancer hospital and their clinical history was retrospectively reviewed. All patients were followed to death, re-intervention, or for at least one year. Stent patency and patient survival were estimated by Kaplan-Meier analysis, supplemented by the log-rank test for comparisons between groups. Forty-eight patients had SEMS placed and 52 patients had plastic stents placed. ERBD was successful in 46 (95.8%) in the SEMS group and 49 (94.2%) in the plastic group (P = 0.67). Median patency times were 1.86 months in the plastic group and 5.56 months in the SEMS group (P < 0.0001). A mean of 1.53 and 4.60 re-interventions were performed in the SEMS and plastic groups, respectively (P < 0.05). Complications occurred in 4/48 (8.3%) in the SEMS group and 4/52 (7.7%) in the plastic group (P = 0.79). Median survival was 9.08 and 8.22 months in the SEMS and plastic stent groups, respectively (P = 0.50). Metallic stent patency was superior to that of plastic stents in all Bismuth-Corlette classifications of hilar cholangiocarcinoma with similar complication rates. SEMS seem to be cost-effective and, when feasible, should be considered as an initial intervention in patients with inoperable hilar cholangiocarcinoma.

  12. Temporary placement of fully covered self-expandable metal stents for the treatment of benign biliary strictures

    PubMed Central

    Chaput, Ulriikka; Vienne, Ariane; Audureau, Etienne; Bauret, Paul; Bichard, Philippe; Coumaros, Dimitri; Napoléon, Bertrand; Ponchon, Thierry; Duchmann, Jean-Christophe; Laugier, René; Lamouliatte, Hervé; Védrenne, Bruno; Gaudric, Marianne; Chaussade, Stanislas; Robin, Françoise; Leblanc, Sarah

    2015-01-01

    Background Endoscopic treatment of benign biliary strictures (BBS) can be challenging. Objective To evaluate the efficacy of fully covered self-expandable metal stents (FCSEMS) in BBS. Methods Ninety-two consecutive patients with BBS (chronic pancreatitis (n = 42), anastomotic after liver transplantation (n = 36), and post biliary surgical procedure (n = 14)) were included. FCSEMS were placed across strictures for 6 months before endoscopic extraction. Early success rate was defined as the absence of biliary stricture or as a minimal residual anomaly on post-stent removal endoscopic retrograde cholangiopancreatography (ERCP). Secondary outcomes were the final success and stricture recurrence rates as well as procedure-related morbidity. Results Stenting was successful in all patients. Stenting associated complications were minor and occurred in 22 (23.9%) patients. Migration occurred in 23 (25%) patients. Stent extraction was successful in all but two patients with proximal stent migration. ERCP after the 6 months stenting showed an early success in 84.9% patients (chronic pancreatitis patients: 94.7%, liver transplant: 87.9%, post-surgical: 61.5%) (p = 0.01). Final success was observed in 57/73 (78.1%) patients with a median follow-up of 12 ± 3.56 months. Recurrence of biliary stricture occurred in 16/73 (21.9%) patients. Conclusions FCSEMS placement is efficient for patients with BBS, in particular for chronic pancreatitis patients. Stent extraction after 6 months indwelling, although generally feasible, may fail in a few cases. PMID:27403307

  13. Temporary placement of fully covered self-expandable metal stents for the treatment of benign biliary strictures.

    PubMed

    Chaput, Ulriikka; Vienne, Ariane; Audureau, Etienne; Bauret, Paul; Bichard, Philippe; Coumaros, Dimitri; Napoléon, Bertrand; Ponchon, Thierry; Duchmann, Jean-Christophe; Laugier, René; Lamouliatte, Hervé; Védrenne, Bruno; Gaudric, Marianne; Chaussade, Stanislas; Robin, Françoise; Leblanc, Sarah; Prat, Frédéric

    2016-06-01

    Endoscopic treatment of benign biliary strictures (BBS) can be challenging. To evaluate the efficacy of fully covered self-expandable metal stents (FCSEMS) in BBS. Ninety-two consecutive patients with BBS (chronic pancreatitis (n = 42), anastomotic after liver transplantation (n = 36), and post biliary surgical procedure (n = 14)) were included. FCSEMS were placed across strictures for 6 months before endoscopic extraction. Early success rate was defined as the absence of biliary stricture or as a minimal residual anomaly on post-stent removal endoscopic retrograde cholangiopancreatography (ERCP). Secondary outcomes were the final success and stricture recurrence rates as well as procedure-related morbidity. Stenting was successful in all patients. Stenting associated complications were minor and occurred in 22 (23.9%) patients. Migration occurred in 23 (25%) patients. Stent extraction was successful in all but two patients with proximal stent migration. ERCP after the 6 months stenting showed an early success in 84.9% patients (chronic pancreatitis patients: 94.7%, liver transplant: 87.9%, post-surgical: 61.5%) (p = 0.01). Final success was observed in 57/73 (78.1%) patients with a median follow-up of 12 ± 3.56 months. Recurrence of biliary stricture occurred in 16/73 (21.9%) patients. FCSEMS placement is efficient for patients with BBS, in particular for chronic pancreatitis patients. Stent extraction after 6 months indwelling, although generally feasible, may fail in a few cases.

  14. 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

    2016-12-07

    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.

  15. 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

  16. 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

  17. [The application of Y-shaped self-expandable covered metal stents in the thoracostomach-airway fistula: a single center, 11 years experience].

    PubMed

    Fang, Yi; Li, Tengfei; Han, Xinwei; Wu, Gang; Ren, Jianzhuang; Ren, Kewei; Lu, Huibin; Zhang, Quanhui; Li, Zongming

    2015-08-01

    To investigate the clinical feasibility and efficacy of Y-shaped self-expandable covered metal stents (Y-stents) in the management of thoracostomach-airway fistula. Retrospective analysis was performed for 108 patients treated for thoracostomach-airway fistula with Y-shaped self-expandable coated metal stents between April 2003 and October 2014. Y-stents were designed based on the dimensions of trachea and bronchus and sites of the fistula and then were inserted under DSA monitoring. There were 65 cases with single big Y-stent placement, 26 cases with single small Y-stent placement, 23 cases with double Y-stents placement, and 1 case with 3 Y-stents placement. Stent implantation was successfully accomplished with single manipulation in all patients. Complete occlusion of the fistula was obtained in 104 patients after the primary manipulation, and 4 patients required a secondary manipulation where a double Y-stents was inserted because of failure of primary manipulate. Ninety-two patients completed the follow-up , while 16 were lost. Fifty-nine patients died while 33 were alive with marked improvement in their quality of life. The placement of Y-stents can effectively occlude the thoracostomach-airway fistula in patients who had had the esophageal tumors resected. The technique is not only feasible but reliable to improve the quality of life of the patients.

  18. Fabrication of balloon-expandable self-lock drug-eluting polycaprolactone stents using micro-injection molding and spray coating techniques.

    PubMed

    Liu, Shih-Jung; Chiang, Fu-Jun; Hsiao, Chao-Ying; Kau, Yi-Chuan; Liu, Kuo-Sheng

    2010-10-01

    The purpose of this report was to develop novel balloon-expandable self-lock drug-eluting poly(ε-caprolactone) stents. To fabricate the biodegradable stents, polycaprolactone (PCL) components were first fabricated by a lab-scale micro-injection molded machine. They were then assembled and hot-spot welded into mesh-like stents of 3 and 5 mm in diameters. A special geometry of the components was designed to self-lock the assembled stents and to resist the external pressure of the blood vessels after being expanded by balloons. Characterization of the biodegradable PCL stents was carried out. PCL stents exhibited comparable mechanical property to that of metallic stents. No significant collapse pressure reduction and weight loss of the stents were observed after being submerged in PBS for 12 weeks. In addition, the developed stent was coated with paclitaxel by a spray coating technique and the release characteristic of the drug was determined by an in vitro elution method. The high-performance liquid chromatography analysis showed that the biodegradable stents could release a high concentration of paclitaxel for more than 60 days. By adopting the novel techniques, we will be able to fabricate biodegradable drug-eluting PCL stents of different sizes for various cardiovascular applications.

  19. An overview of thin film nitinol endovascular devices.

    PubMed

    Shayan, Mahdis; Chun, Youngjae

    2015-07-01

    Thin film nitinol has unique mechanical properties (e.g., superelasticity), excellent biocompatibility, and ultra-smooth surface, as well as shape memory behavior. All these features along with its low-profile physical dimension (i.e., a few micrometers thick) make this material an ideal candidate in developing low-profile medical devices (e.g., endovascular devices). Thin film nitinol-based devices can be collapsed and inserted in remarkably smaller diameter catheters for a wide range of catheter-based procedures; therefore, it can be easily delivered through highly tortuous or narrow vascular system. A high-quality thin film nitinol can be fabricated by vacuum sputter deposition technique. Micromachining techniques were used to create micro patterns on the thin film nitinol to provide fenestrations for nutrition and oxygen transport and to increase the device's flexibility for the devices used as thin film nitinol covered stent. In addition, a new surface treatment method has been developed for improving the hemocompatibility of thin film nitinol when it is used as a graft material in endovascular devices. Both in vitro and in vivo test data demonstrated a superior hemocompatibility of the thin film nitinol when compared with commercially available endovascular graft materials such as ePTFE or Dacron polyester. Promising features like these have motivated the development of thin film nitinol as a novel biomaterial for creating endovascular devices such as stent grafts, neurovascular flow diverters, and heart valves. This review focuses on thin film nitinol fabrication processes, mechanical and biological properties of the material, as well as current and potential thin film nitinol medical applications.

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

    PubMed Central

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

    2004-01-01

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

  1. Use of expanded polytetrafluoroethylen (ePTFE) stent graft in autogenic AV fistula with false aneurysm in lower extremity.

    PubMed

    Sieroń, Dominik; Wiggermann, Philipp; Knap, Daniel; Wawrzynek, Wojciech; Stroszczynski, Christian

    2012-04-01

    A 28-year-old German-Caucasian man arrived with deep vein thrombosis DVT, pain, oedema and rubor of right lower limb and drug abuse. The US Doppler imaging showed an autogenic AV fistula and false aneurysm of the right superficial femoral artery and femoral vein. The CT imaging showed additional closing of the left external iliac artery and common femoral artery, and of the distal and middle parts of the superficial femoral artery. The patient was treated within the angiography suite using a 8/25 mm (8 mm diameter/25 mm length) peripheral graft with expanded polytetrafluoroethylen ePTFE stent. After stent deployment, the dilatation was performed using 8/20 mm (8 mm diameter/20 mm length) balloons. After intervention, the digital subtraction angiography showed a good stent position with complete exclusion of false aneurysm and AV fistula. The outcome of US Doppler imaging also confirmed successful intervention.

  2. Palliation of Obstructing Malignant Colonic Lesions Using Self-Expanding Metal Stents: A Single-Center Experience

    SciTech Connect

    Shrivastava, Vivek; Tariq, Omar; Tiam, ReeNee; Nyhsen, Christiane; Marsh, Ralph

    2008-09-15

    To evaluate the efficacy, risks, and survival after palliative colorectal stenting at a single center, we conducted a retrospective review of consecutive patients who had colorectal self-expanding metal stents (SEMSs) inserted over an 8-year period (September 1998 to September 2006) to relieve an obstructing colorectal tumor. All patients either had proven distant metastases or were unfit for surgical decompression. A single interventional radiologist (R.M.) inserted the stents, which were either Memotherm or WallFlex. Ninety-one patients with a median age of 73 years had a colorectal stent inserted for palliation of an obstructing colorectal malignancy. Technical success was achieved in 81 of 91 (89%) patients, and clinical success in 80 of 81 (99%). At the time of analysis (December 2006), 13 of 91 (14.2%) patients were alive. The patients who died had a median survival of 59 days, IQR 17-181 days. Seven (7/81) patients suffered stent migration, which occurred 10.3 days (IQR, 5-14 days) after the procedure. Three patients (3/81) re-presented with intestinal obstruction secondary to tumor ingrowth and 10 (10.9%) patients suffered bowel perforation. Ten patients (10.9%) had two stents inserted coaxially and overlapping in one procedure. This was performed in cases where the stricture was too long to be easily crossed by a single stent. We conclude that colorectal SEMS is a safe and effective mode of treatment for the palliation of obstructing colorectal cancers, which avoids high-risk surgery.

  3. Clinical benefits and oncologic equivalence of self-expandable metallic stent insertion for right-sided malignant colonic obstruction.

    PubMed

    Ji, Woong Bae; Kwak, Jung Myun; Kang, Dong Woo; Kwak, Han Deok; Um, Jun Won; Lee, Sun-Il; Min, Byung-Wook; Sung, Nak Song; Kim, Jin; Kim, Seon Hahn

    2017-01-01

    The efficacy of stenting for right-sided malignant colonic obstruction is unknown. This study aimed to evaluate the safety, feasibility, and clinical benefits of self-expandable metallic stent insertion for right-sided malignant colonic obstruction. Clinical data from patients who underwent right hemicolectomy for right colon cancer from January 2006 to July 2014 at three Korea University hospitals were retrospectively reviewed. A total of 39 patients who developed malignant obstruction in the right-sided colon were identified, and their data were analyzed. Stent insertion was attempted in 16 patients, and initial technical success was achieved in 14 patients (87.5 %). No stent-related immediate complications were reported. Complete relief from obstruction was achieved in all 14 patients. Twenty-five patients, including two patients who failed stenting, underwent emergency surgery. In the stent group, 93 % (13/14) of patients underwent elective laparoscopic surgery, and only one surgery was converted to an open procedure. All patients in the emergency group underwent emergency surgery within 24 h of admission. In the emergency group, only 12 % (3/25) of patients underwent laparoscopic surgery, with one surgery converted to an open procedure. All patients in both groups underwent either laparoscopy-assisted or open right/extended right hemicolectomy with primary anastomoses as the first operation. The operative times, retrieved lymph nodes, and pathologic stage did not differ between the two groups. Postoperative hospital stay (9.4 ± 3.4 days in the stent group vs. 12.4 ± 5.9 in the emergency group, p = 0.089) and time to resume oral food intake (3.2 ± 2.1 days in the stent group vs. 5.7 ± 3.4 in the emergency group, p = 0.019) were shorter in the stent group. And there were no significant differences in disease-free survival and overall survival between the two groups. Stent insertion appears to be safe and feasible in patients with right

  4. Leo Stent for Endovascular Treatment of Broad-Necked and Fusiform Intracranial Aneurysms

    PubMed Central

    Juszkat, R.; Nowak, S.; Smól, S.; Kociemba, W.; Blok, T.; Zarzecka, A.

    2007-01-01

    Summary The advent of intracranial stents has widened the indications for endovascular treatment of broad-necked and fusiform aneurysms. Leo stent is a self-expandable, nitinol, braided stent dedicated to intracranial vessels. The aim of this study is to present our experience in endovascular treatment of broad-necked and fusiform intracranial aneurysms using self-expanding, nitinol Leo stents. Between February 2004 and November 2006, 25 broad-necked and three fusiform aneurysms in 28 patients were treated using Leo stents in our centre. There were 18 patients who experienced acute subarachnoid haemorrhage due to aneurysm rupture, two patients who experienced SAH at least 12 months ago and in eight patients aneurysms were found incidentally. Aneurysms were located as follows: internal carotid artery15, basilar artery5, basilar tip3, posterior inferior cerebral artery2, M1/M2 segment1, A2 segment1 and vertebral artery1. There were no difficulties with stent deployment and delivery. All patients after acute SAH (n=18) underwent stent implantation and coil embolization in one procedure. The remaining patients underwent coil embolization in a staged procedure. Immediate aneurysm occlusion of more than 95% was achieved in all patients who underwent stent placement and coil embolization in one procedure. There were three thromboembolic complications encountered in patients in an acute setting of SAH, preloaded only on acetylsalicylic acid. Use of abciximab led to patency within the stent and parent vessel. However, one of these patients presented rebleeding from the aneurysm during administration of abciximab and died. Application of Leo stents in cases of broadnecked and fusiform intracranial aneurysms is safe and effective with a low complication rate. PMID:20566117

  5. Esophageal self-expandable stent material and mesh grid density are the major determining factors of external beam radiation dose perturbation: results from a phantom model.

    PubMed

    Abu Dayyeh, B K; Vandamme, J J; Miller, R C; Baron, T H

    2013-01-01

    Self-expandable esophageal stents are increasingly used for palliation or as an adjunct to chemoradiation for esophageal neoplasia. The optimal esophageal stent design and material to minimize dose perturbation with external beam radiation are unknown. We sought to quantify the deviation from intended radiation dose as a function of stent material and mesh density design. A laboratory dosimetric film model was used to quantify perturbation of intended radiation dose among 16 different esophageal stents with varying material and stent mesh density design. Radiation dose enhancement due to stent backscatter ranged from 0 % to 7.3 %, collectively representing a standard difference from the intended mean radiation dose of 1.9 (95 % confidence interval [CI] 1.5 - 2.2). This enhancement was negligible for polymer-based stents and approached 0 % for the biodegradable stents. In contrast, all metal alloy stents had significant radiation backscatter; this was largely determined by the density of mesh design and not by the type of alloy used. Stent characteristics should be considered when selecting the optimal stent for treatment and palliation of malignant esophageal strictures, especially when adjuvant or neo-adjuvant radiotherapy is planned. © Georg Thieme Verlag KG Stuttgart · New York.

  6. Drug-Eluting Nitinol Stent Treatment of the Superficial Femoral Artery and Above-the-Knee Popliteal Artery (The Zilver PTX Single-Arm Clinical Study): A Comparison Between Diabetic and Nondiabetic Patients

    SciTech Connect

    Fanelli, Fabrizio; Primo, Massimiliano Di; Boatta, Emanuele; Johnston, Krystal; Sapoval, Marc

    2013-10-15

    Purpose: To describe the 1-year results of drug-eluting nitinol stent placement in the femoropopliteal artery of diabetic and nondiabetic patients. Materials and Methods: All patients enrolled in this prospective, multicenter study underwent paclitaxel-eluting stent placement for de novo or restenotic lesions of the superficial femoral and/or popliteal artery. Baseline and follow-up walking impairment questionnaire (WIQ) scores, Rutherford classifications, and ankle-brachial index (ABI) measurements were obtained. Follow-up was completed at 1, 6, and 12 months. Results: There were 285 diabetic patients and 502 nondiabetic patients treated. There were no significant differences in mean lesion length or lesion calcification between patient groups. Procedural success in both treatment groups was >97 %. There were no significant differences between diabetic and nondiabetic groups in Kaplan-Meier estimates of patency, event-free survival (EFS), or freedom from target lesion revascularization (TLR) at 6 and 12 months. Both groups experienced a significant increase in ABI and WIQ values after treatment, and these improvements were sustained to 12-month follow-up; however, nondiabetic patients had significantly greater 6- and 12-month WIQ scores compared with diabetic patients. Based on covariate analysis, the only factors shown to be significant and to negatively influence patency were longer lesion length (p = 0.009), higher Rutherford classification (p = 0.02), and lack of hypertension (p = 0.02); diabetic status was not found to be a significant factor. Conclusion: Diabetic and nondiabetic patients had similar estimates of primary patency, EFS, and freedom from TLR; however, diabetic patients showed less improvement in WIQ scores compared with nondiabetic patients.

  7. A thin film nitinol heart valve.

    PubMed

    Stepan, Lenka L; Levi, Daniel S; Carman, Gregory P

    2005-11-01

    In order to create a less thrombogenic heart valve with improved longevity, a prosthetic heart valve was developed using thin film nitinol (NiTi). A "butterfly" valve was constructed using a single, elliptical piece of thin film NiTi and a scaffold made from Teflon tubing and NiTi wire. Flow tests and pressure readings across the valve were performed in vitro in a pulsatile flow loop. Bio-corrosion experiments were conducted on untreated and passivated thin film nitinol. To determine the material's in vivo biocompatibility, thin film nitinol was implanted in pigs using stents covered with thin film NiTi. Flow rates and pressure tracings across the valve were comparable to those through a commercially available 19 mm Perimount Edwards tissue valve. No signs of corrosion were present on thin film nitinol samples after immersion in Hank's solution for one month. Finally, organ and tissue samples explanted from four pigs at 2, 3, 4, and 6 weeks after thin film NiTi implantation appeared without disease, and the thin film nitinol itself was without thrombus formation. Although long term testing is still necessary, thin film NiTi may be very well suited for use in artificial heart valves.

  8. Excimer Laser LEsion modification to expand non-dilatable stents: the ELLEMENT registry.

    PubMed

    Latib, Azeem; Takagi, Kensuke; Chizzola, Giuliano; Tobis, Jonathan; Ambrosini, Vittorio; Niccoli, Giampaolo; Sardella, Gennaro; DiSalvo, Maria Elena; Armigliato, Pietro; Valgimigli, Marco; Tarsia, Giandomenico; Gabrielli, Gabriele; Lazar, Lawrence; Maffeo, Diego; Colombo, Antonio

    2014-01-01

    Stent underexpansion is a risk factor for in-stent restenosis and stent thrombosis. Existing techniques to optimize stent expansion are sometimes ineffective. The aim of this study was to evaluate the effectiveness and feasibility of Excimer Laser Coronary Angioplasty (ELCA) in improving stent expansion when high-pressure non-compliant balloon inflation was ineffective. ECLA ablation was performed at high energy during contrast injection and only within the underexpanded stent. The primary endpoint of successful laser dilatation was defined as an increase of at least 1mm(2) in minimal stent cross-sectional area (MSA) on IVUS or an increase of at least 20% in minimal stent diameter (MSD) by QCA, following redilatation with the same non-compliant balloon that had been unsuccessful prior to ELCA. Secondary endpoints were cardiac death, myocardial infarction (MI) and target lesion revascularization. Between June 2009 and November 2011, 28 patients with an underexpanded stent despite high-pressure balloon inflation were included. The mean laser catheter size was 1.2±0.4 (range 0.9-2.0mm) and a mean of 62±12mJ/mm(2) at 62±21hertz were required for optimal expansion. Laser-assisted stent dilatation was successful in 27 cases (96.4%), with an improvement in MSD by QCA (1.6±0.6mm at baseline to 2.6±0.6mm post-procedure) and MSA by IVUS (3.5±1.1mm(2) to 7.1±1.9mm(2)). Periprocedural MI occurred in 7.1%, transient slow-flow in 3.6% and ST elevation in 3.6%. During follow-up, there were no MIs, there was 1 cardiac-death, and TLR occurred in 6.7%. The ELLEMENT study confirms the feasibility of ELCA with contrast injection to improve stent underexpansion in undilatable stented lesions. © 2014.

  9. Analytical Models for Predicting Mechanical Properties of Self-Expandable Metal Stents with Cover Membrane

    DTIC Science & Technology

    2007-11-02

    compressed, it elongates in its longitudinal direction. Consider the deformation of parallelogram cell as shown in Fig. 4(A). When the points A, B, and...the cell maintains a parallelogram shape during compression. The length between A and B of uncompressed stent is N klL wireAB 0 sin2 β= (14...Expansive pressure- deformation curve for bare type stent. 8 10 12 14 16 0 4 8 12 16 Experiments Pbare Pcoat Pcoated stent

  10. Stent-Assisted Coil Embolization of a Mycotic Renal Artery Aneurysm by Use of a Self-Expanding Neurointerventional Stent

    SciTech Connect

    Rabellino, Martin; Garcia-Nielsen, Luis; Zander, Tobias Baldi, Sebastian; Llorens, Rafael; Maynar, Manuel

    2011-02-15

    Mycotic aneurysms are uncommon, especially those located in visceral arteries. We present a case of a patient with two visceral mycotic aneurysms due to bacterial endocarditis, one located in right upper pole renal artery and the second in the splenic artery. Both aneurysms were treated as endovascular embolization using microcoils. In the aneurysm located at the renal artery, the technique of stent-assisted coils embolization was preferred to avoid coils migration due to its wide neck. The stent used was the Solitaire AB, which was designed for the treatment of intracranial aneurysms and was used recently in acute stroke as a mechanical thrombectomy device. Complete embolization of the aneurysm was achieved, preserving all the arterial branches without nephrogram defects in the final angiogram.

  11. Reversal of Transjugular Intrahepatic Portosystemic Shunt (TIPS)-Induced Hepatic Encephalopathy Using a Strictured Self-Expanding Covered Stent

    SciTech Connect

    Cox, Mitchell W.; Soltes, George D.; Lin, Peter H. Bush, Ruth L.; Lumsden, Alan B.

    2003-11-15

    Hepatic encephalopathy is a known complication following percutaneous transjugular intrahepatic portosystemic shunt (TIPS) placement. We describe herein a simple and effective strategy of TIPS revision by creating an intraluminal stricture within a self-expanding covered stent, which is deployed in the portosystemic shunt to reduce the TIPS blood flow. This technique was successful in reversing a TIPS-induced hepatic encephalopathy in our patient.

  12. A Prospective, Randomized Study of an Expanded Polytetrafluoroethylene Stent Graft versus Balloon Angioplasty for In-Stent Restenosis in Arteriovenous Grafts and Fistulae: Two-Year Results of the RESCUE Study.

    PubMed

    Falk, Abigail; Maya, Ivan D; Yevzlin, Alexander S

    2016-10-01

    To assess the safety and efficacy of an expanded polytetrafluoroethylene stent graft versus balloon angioplasty for the treatment of in-stent restenosis in the venous outflow of hemodialysis access grafts and fistulae. Two hundred seventy-five patients were randomized at 23 US sites to stent-graft placement or percutaneous transluminal angioplasty (PTA). Primary study endpoints were access circuit primary patency (ACPP) at 6 months and safety through 30 days; secondary endpoints were evaluated through 24 months. ACPP at 6 months was significantly higher in the stent-graft group (18.6%) versus the PTA group (4.5%; P < .001), and freedom from safety events (30 days) was comparable (stent graft, 96.9%; PTA, 96.4%; P = .003 for noninferiority). The separation in ACPP survival curves remained through 12 months (stent graft, 6.2%; PTA, 1.5%). Treatment area primary patency (TAPP) was superior for the stent-graft group (66.4%) versus the PTA group (12.3%) at 6 months (P < .001), with a survivorship difference in favor of stent-graft placement maintained through 24 months (stent graft, 15.6%; PTA, 2.2%). ACPP and TAPP for the stent-graft group were better than those for the PTA group when compared within central and peripheral vein subgroups (P < .001). In central veins, TAPP was 13.6% in the stent-graft group versus 4.3% in the PTA group at 24 months (P < .001). Stent-graft use provided better ACPP and TAPP than PTA when treating in-stent restenosis in patients receiving dialysis with arteriovenous grafts and fistulae. Copyright © 2016 SIR. Published by Elsevier Inc. All rights reserved.

  13. Stent-Assisted Clip Placement for Complex Internal Carotid Artery Intracranial Aneurysms

    PubMed Central

    Qureshi, Adnan I.; Chughtai, Morad; Khan, Asif A.; Suri, M. Fareed K.; Sherr, Gregory T.

    2016-01-01

    BACKGROUND We report two procedures using a stent-assisted microsurgical clip placement to treat complex intracranial aneurysms originating from supraclinoid segment of the internal carotid artery. CASE DESCRIPTIONS In both procedures, primary clip placement was considered technically difficult due to either complex morphology or inferior protrusion of aneurysm fundus within the interclinoid space. A nitinol self-expanding stent was placed across the neck of the aneurysm either preoperatively or intraoperatively. Obliteration of aneurysm and patency of the artery was confirmed by angiography after clip placement. CONCLUSION Description of an integrated open microsurgical and endovascular approach and review of literature pertaining to considerations for treatment approach are discussed. PMID:26958150

  14. Are Carotid Stent Fractures Clinically Significant?

    SciTech Connect

    Garcia-Toca, Manuel; Rodriguez, Heron E.; Naughton, Peter A.; Keeling, Aiofee; Phade, Sachin V.; Morasch, Mark D.; Kibbe, Melina R.; Eskandari, Mark K.

    2012-04-15

    Purpose: Late stent fatigue is a known complication after carotid artery stenting (CAS) for cervical carotid occlusive disease. The purpose of this study was to determine the prevalence and clinical significance of carotid stent fractures. Materials and Methods: A single-center retrospective review of 253 carotid bifurcation lesions treated with CAS and mechanical embolic protection from April 2001 to December 2009 was performed. Stent integrity was analyzed by two independent observers using multiplanar cervical plain radiographs with fractures classified into the following types: type I = single strut fracture; type II = multiple strut fractures; type III = transverse fracture; and type IV = transverse fracture with dislocation. Mean follow-up was 32 months. Results: Follow-up imaging was completed on 106 self-expanding nitinol stents (26 closed-cell and 80 open-cell stents). Eight fractures (7.5%) were detected (type I n = 1, type II n = 6, and type III n = 1). Seven fractures were found in open-cell stents (Precise n = 3, ViVEXX n = 2, and Acculink n = 2), and 1 fracture was found in a closed-cell stent (Xact n = 1) (p = 0.67). Only a previous history of external beam neck irradiation was associated with fractures (p = 0.048). No associated clinical sequelae were observed among the patients with fractures, and only 1 patient had an associated significant restenosis ({>=}80%) requiring reintervention. Conclusions: Late stent fatigue after CAS is an uncommon event and rarely clinically relevant. Although cell design does not appear to influence the occurrence of fractures, lesion characteristics may be associated risk factors.

  15. Influence of different self-expanding stent-graft types on remodeling of the aortic neck after endovascular aneurysm repair.

    PubMed

    Oberhuber, Alexander; Schwarz, Alexander; Hoffmann, Martin H; Klass, Oliver; Orend, Karl-Heinz; Mühling, Bernd

    2010-12-01

    To evaluate aortic neck changes, specifically aortic neck dilatation, over a 10-year period in patients undergoing endovascular aneurysm repair (EVAR) for abdominal aortic aneurysm. All patients who underwent elective EVAR at our institution from 1998 through 2007 were analyzed retrospectively. Among these, 103 patients (96 men; mean age 71 years, range 35-84) who received the 3 most frequently implanted self-expanding stent-grafts (35 Talent, 39 Excluder, and 29 Zenith) and had a minimum 3-month imaging follow-up at our department were selected for this study. All diameters were measured perpendicular to the centerline of flow on computed tomography; baseline data were derived from the first postoperative scan. Stent-graft migration was measured from the lowermost renal artery to the first strut of the stent-graft. Based on intra- and interobserver error measurements, a minimum change of 2 mm defined aortic neck dilatation. During a mean follow-up of 39.4 months (range 3-108.8), infrarenal aortic neck dilatation (>2 mm) was found in 10 patients (28.6%, 95% CI 14.6-46.3) in the Talent group, 4 (10.3%, 95% CI 2.9-24.2) in the Excluder group, and 9 (31.0%, 95% CI 15.3-50.8) in the Zenith group (p=0.299). In 7 (31%) of the 23 patients with neck dilatation, additional therapy was necessary. Suprarenal changes were found in 6 patients (17.1%, 95% CI 6.6-33.6), 8 patients (20.5%, 95% CI 9.3-36.5), and 5 patients (17.2%, 95% CI 5.8-35.8), respectively (p=0.218). Stent-graft migration >2 mm was seen in 2 (1.9%) of the 103 patients in follow-up. The overall endoleak rates were 37.1% for Talent, 30.8% for Excluder, and 37.9% for Zenith (p>0.05). Two patients were converted to open repair owing to Talent stent-graft migration and persistent type I leak (Zenith). The overall reintervention rate was 13.6% (13/103). Only a small number of the patients treated with self-expanding stent-grafts show notable infrarenal aortic neck dilatation, which does not appear to be related to

  16. Present and future of endovascular SFA treatment: stents, stent-grafts, drug coated balloons and drug coated stents.

    PubMed

    Bosiers, M; Deloose, K; Verbist, J; Peeters, P

    2008-04-01

    The current evolution towards treating more complex femoropopliteal lesions as seen in the renewed TASC II recommendations clearly reflects the continuous evolutions in femoropopliteal stent design. Recent stent design improvements focus on decreasing stent fractures rates which can negatively impact patency rates. By rearranging strut alignment towards helical connecting bridges or full helical stent designs, stent designers have successfully improved the fracture resistance of their stents. The superior fracture resistance of the latest stent generation in combination with the production of long nitinol stents of up to 20 cm in length allow that more difficult and complex lesions can be treated endovascularly. The continuous perfection of nitinol stent platforms followed by the transfer of coronary technologies (e.g. active coatings) towards peripheral devices might broaden the indications for the minimal invasive strategy towards TransAtlantic Inter-Society Consensus (TASC) II C&D lesions.

  17. MR Angiography of Peripheral Arterial Stents: In Vitro Evaluation of 22 Different Stent Types

    PubMed Central

    Burg, Matthias C.; Bunck, Alexander C.; Seifarth, Harald; Buerke, Boris; Kugel, Harald; Hesselmann, Volker; Köhler, Michael; Heindel, Walter; Maintz, David

    2011-01-01

    Purpose. To evaluate stent lumen visibility of a large sample of different peripheral arterial (iliac, renal, carotid) stents using magnetic resonance angiography in vitro. Materials and Methods. 21 different stents and one stentgraft (10 nitinol, 7 316L, 2 tantalum, 1 cobalt superalloy, 1 PET + cobalt superalloy, and 1 platinum alloy) were examined in a vessel phantom (vessel diameters ranging from 5 to 13 mm) filled with a solution of Gd-DTPA. Stents were imaged at 1.5 Tesla using a T1-weighted 3D spoiled gradient-echo sequence. Image analysis was performed measuring three categories: Signal intensity in the stent lumen, lumen visibility of the stented lumen, and homogeneity of the stented lumen. The results were classified using a 3-point scale (good, intermediate, and poor results). Results. 7 stents showed good MR lumen visibility (4x nitinol, 2x tantalum, and 1x cobalt superalloy). 9 stents showed intermediate results (5x nitinol, 2x 316L, 1x PET + cobalt superalloy, and 1x platinum alloy) and 6 stents showed poor results (1x nitinol, and 5x 316L). Conclusion. Stent lumen visibility varies depending on the stent material and type. Some products show good lumen visibility which may allow the detection of stenoses inside the lumen, while other products cause artifacts which prevent reliable evaluation of the stent lumen with this technique. PMID:22091380

  18. Self-expanding metal mesh stents and laser therapy: a complementary approach for the palliation of malignant dysphagia

    NASA Astrophysics Data System (ADS)

    Madhotra, Ravi; Raouf, A.; Sturgess, R.; Krasner, Neville

    1997-12-01

    Re-establishment of the oesophageal lumen is the main focus of care in patients with inoperable oesophageal carcinomas. The self-expanding metal mesh stents (MMS) are increasingly being used. 51 patients aged 44 - 89 with inoperable oesophago-gastric carcinomas were intubated with MMS. 18 of these patients had endoscopic laser therapy (ELT) as primary palliation. 25 patients required follow-up endoscopy at variable intervals after stent insertion. 17 patients were found to have significant tumor growth (9), overgrowth (4) and both (4). All these patients were treated with Nd:YAG or diode laser for maintenance of satisfactory swallowing. 4 patients being treated with Nd:YAG laser developed deformity of MMS. This complication was not encountered with diode laser. The reblockage of MMS due to ingrowth or overgrowth of tumor is a not uncommon complication. The timing of the stent insertion should be carefully chosen since the longer the stent is in situ, the greater is the likelihood of tumor ingrowth or overgrowth. ELT can effectively deal with tumor ingrowth and overgrowth. Nd:YAG laser can cause melting of MMS. Overall the combination of ELT and MMS may offer the best palliation, particularly when patient survival of several months is anticipated.

  19. Self-expandable metal stents for obstructing colonic and extracolonic cancer: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline.

    PubMed

    van Hooft, Jeanin E; van Halsema, Emo E; Vanbiervliet, Geoffroy; Beets-Tan, Regina G H; DeWitt, John M; Donnellan, Fergal; Dumonceau, Jean-Marc; Glynne-Jones, Robert G T; Hassan, Cesare; Jiménez-Perez, Javier; Meisner, Søren; Muthusamy, V Raman; Parker, Michael C; Regimbeau, Jean-Marc; Sabbagh, Charles; Sagar, Jayesh; Tanis, Pieter J; Vandervoort, Jo; Webster, George J; Manes, Gianpiero; Barthet, Marc A; Repici, Alessandro

    2014-11-01

    This Guideline is an official statement of the European Society of Gastrointestinal Endoscopy (ESGE). This Guideline was also reviewed and endorsed by the Governing Board of the American Society for Gastrointestinal Endoscopy (ASGE). The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system was adopted to define the strength of recommendations and the quality of evidence. Main recommendations The following recommendations should only be applied after a thorough diagnostic evaluation including a contrast-enhanced computed tomography (CT) scan. 1 Prophylactic colonic stent placement is not recommended. Colonic stenting should be reserved for patients with clinical symptoms and imaging evidence of malignant large-bowel obstruction, without signs of perforation (strong recommendation, low quality evidence). 2 Colonic self-expandable metal stent (SEMS) placement as a bridge to elective surgery is not recommended as a standard treatment of symptomatic left-sided malignant colonic obstruction (strong recommendation, high quality evidence). 3 For patients with potentially curable but obstructing left-sided colonic cancer, stent placement may be considered as an alternative to emergency surgery in those who have an increased risk of postoperative mortality, I. e. American Society of Anesthesiologists (ASA) Physical Status ≥ III and/or age > 70 years (weak recommendation, low quality evidence). 4 SEMS placement is recommended as the preferred treatment for palliation of malignant colonic obstruction (strong recommendation, high quality evidence), except in patients treated or considered for treatment with antiangiogenic drugs (e. g. bevacizumab) (strong recommendation, low quality evidence).

  20. Corrosion Behavior of Platinum-Enhanced Radiopaque Stainless Steel (PERSS®) for Dilation-Baloon Expandable Coronary Stents

    SciTech Connect

    Covino, Jr., Bernard S.; Craig, Charles H.; Cramer, Stephen D.; Bullard, Sophie J.; Ziomek-Moroz, Margaret; Jablonski, Paul D.; Turner, Paul C.; Radisch, Jr., Herbert R.; Gokcen, Nev A.; Friend, Clifford M.; Edwards, Michael R.

    2002-05-01

    Dilation-balloon expandable coronary stents are commonly made of implant grade stainless steels conforming to ASTM F138/F139, e.g., Biodur? 316LS (UNS S31673). Typical of such stents is the Boston Scientific/Interventional Technologies? (BS/IVT) LP-StentTM. In 2000, BS/IVT determined that the addition of 5 to 6 wt % platinum to Biodur 316LS produced a stainless steel with enhanced radiopacity to make their stents more visible radiographically and thus more effective clinically. A goal of the program was to ensure platinum additions would not adversely affect the corrosion resistance of Biodur 316LS. The corrosion resistance of 5-6 wt % PERSS? alloys and Biodur 316LS was determined using electrochemical tests for general, pitting, crevice and intergranular corrosion. Experimental methods included ASTM A262E, F746, F2129, and potentiodynamic polarization. The 6 wt % PERSS? alloy (IVT 78) had a resistance to pitting, crevice and intergranular corrosion that was similar to the Biodur 316LS base material. IVT 78 was a single-phase austenitic alloy with no evidence of inclusions or precipitates. It was more resistant to pitting corrosion than 5 wt % PERSS? alloys. Performance of the PERSS? alloys was not a function of alloy oxygen content in the range 0.01 to 0.03 wt %.

  1. Self-Expanding Metal Stents for Palliative Treatment of Superior Vena Caval Syndrome

    SciTech Connect

    Oudkerk, Matthijs; Kuijpers, Theodore J.A.

    1996-05-15

    Purpose: Two stent types (a new Wallstent and a Z-stent) were investigated in 30 patients with recurrent malignant superior vena caval syndrome (SVCS). Methods: Eligibility requirements were that the patient had recurrent symptoms after appropriate radiation therapy, chemotherapy, or both; {>=}75% of the vessel was occluded; and there was collateral flow. Because of the limited availability of stents, it was not possible to perform a prospectively randomized study. Results: In the Z-stent group (17 patients), occlusion of the stent due to acute thrombosis occurred within 12 hr in 4 patients (24%), but in the other 13 patients (76%) symptoms disappeared completely. After 2 weeks the cavogram in these patients showed no signs of thrombosis, and 12 (71%) of the patients remained symptom-free. There was partial occlusion in 5 patients (29%), without relevant clinical symptoms. Of the 13 patients who received Wallstents, only 1 had an acute immediate thrombosis (8%). Symptoms disappeared completely in the other 12 patients and no signs of thrombosis were seen. However, after 2 weeks complete stent occlusion with SVCS was found in 3 patients (23%) and partial occlusion with minor clinical symptoms in 6 (46%). Only 3 patients (23%) had complete relief of their SVCS. The difference between the rates of occlusion of the two stents after 2 weeks was highly significant (p= 0.008). Conclusions: The overall clinical success rate for long-term patency was 100% for the Z-stents and 69% for the new Wallstent. These results suggest that when used for this purpose, the new Wallstent is more thrombogenic at 2 weeks than the Z-stent.

  2. Primary patency of percutaneously inserted self-expanding metallic stents in patients with malignant biliary obstruction

    PubMed Central

    Dahlstrand, Ursula; Sandblom, Gabriel; Eriksson, Lars-Gunnar; Nyman, Rickard

    2009-01-01

    Background: Effective bile duct drainage is crucial to the health-related quality of life of patients with jaundice caused by obstruction of the bile duct by inoperable malignant tumours. Methods: All patients who were treated at Uppsala University Hospital, Sweden with percutaneous stenting between 2000 and 2005 were identified retrospectively. Data on the location of the obstruction and type of stent used, date and cause of death and date of stent failure were abstracted from the patients' notes. Stent patency was defined as the duration from the insertion of the stent to the date of failure. In cases in which the cause of death was directly related to failure of the stent, the date of death was defined as the patency endpoint. Results: A total of 64 patients (34 women, 30 men) were identified. Their mean age was 71 years (standard deviation 11 years). The median length of patency was 11.4 months. Stent diameter >10 mm and distal stricture were found to be associated with significantly longer patency time in univariate Cox proportional hazard analysis. In multivariate Cox proportional hazard analysis, only location of the stricture was found to be independently and significantly associated with patency time. Discussion: Percutaneous stenting is a good alternative for patients with obstructive jaundice and a life expectancy ≤1 year. It may give instant relief from the symptoms associated with jaundice. Patency time may be prolonged by using stents with a diameter ≥10 mm. However, patency time was found to be lower for hilar tumours. PMID:19718365

  3. Lubrication of Nitinol 60

    NASA Technical Reports Server (NTRS)

    Pepper, Stephen V.; DellaCorte, Christopher; Glennon, Glenn

    2010-01-01

    The mechanical properties of Nitinol 60, 60 wt% Ni, 40 wt% Ti (55 at.% Ni, 45 at.% Ti) are sufficiently attractive to warrant its consideration as a lubricated triboelement. Triboelements are always run lubricated. The ability to lubricate Nitinol 60 by the oils usually used on spacecraft mechanisms--Pennzane 2001A, Krytox 143AC and Castrol 815Z--was experimentally determined. These oils were run in the boundary lubrication regime for Nitinol 60 balls running against Nitinol 60 counterfaces in the vacuum spiral orbit tribometer. Test results consisting of the coefficient of friction versus time (friction traces) and relative degradation rates of the oils are presented. Contrary to the inability to successfully lubricate other metal alloys with high titanium content, it was found that Nitinol 60 is able to be lubricated by these oils. Overall, the results presented here indicate that Nitinol 60 is a credible candidate material for bearing applications.

  4. Intimal hyperplasia following implantation of helical-centreline and straight-centreline stents in common carotid arteries in healthy pigs: influence of intraluminal flow†

    PubMed Central

    Caro, Colin Gerald; Seneviratne, Anusha; Heraty, Kevin B.; Monaco, Claudia; Burke, Martin G.; Krams, Rob; Chang, Carlos C.; Coppola, Gianfilippo; Gilson, Paul

    2013-01-01

    Intimal hyperplasia (IH) is a leading cause of obstruction of vascular interventions, including arterial stents, bypass grafts and arteriovenous grafts and fistulae. Proposals to account for arterial stent-associated IH include wall damage, low wall shear stress (WSS), disturbed flow and, although not widely recognized, wall hypoxia. The common non-planarity of arterial geometry and flow, led us to develop a bare-metal, nitinol, self-expanding stent with three-dimensional helical-centreline geometry. This was deployed in one common carotid artery of healthy pigs, with a straight-centreline, but otherwise identical (conventional) stent deployed contralaterally. Both stent types deformed the arteries, but the helical-centreline device additionally deformed them helically and caused swirling of intraluminal flow. At sacrifice, one month post stent deployment, histology revealed significantly less IH in the helical-centreline than straight-centreline stented vessels. Medial cross-sectional area was not significantly different in helical-centreline than straight-centreline stented vessels. By contrast, luminal cross-sectional area was significantly larger in helical-centreline than straight-centreline stented vessels. Mechanisms considered to account for those results include enhanced intraluminal WSS and enhanced intraluminal blood–vessel wall mass transport, including of oxygen, in the helical-centreline stented vessels. Consistent with the latter proposal, adventitial microvessel density was lower in the helical-centreline stented than straight-centreline stented vessels. PMID:24132200

  5. Y-Shaped Bilateral Self-Expandable Metallic Stent Placement for Malignant Hilar Biliary Obstruction: Data from a Referral Center for Palliative Care

    PubMed Central

    Di Mitri, R.; Mocciaro, F.

    2014-01-01

    Background and Aim. Malignant hilar strictures are a clinical challenge because of the current therapeutic approach and the poor prognosis. In recent years, self-expandable metallic stents have proven more effective than plastic stents for palliation of malignant hilar strictures, with the bilateral stent-in-stent technique registering a high success rate. We report our experience with Y-shaped endoscopic self-expandable metallic stents placement for treatment of advanced malignant hilar strictures. Methods. From April 2009 to August 2012, we prospectively collected data on patients treated with Y-shaped SEMS placement for advanced malignant hilar carcinoma. Data on technical success, clinical success, and complications were collected. Results. Twenty patients (9 males) were treated (mean age 64.2 ± 15.3 years). The grade of malignant hilar strictures according to the Bismuth classification was II in 5 patients (25%), IIIa in 1 (5%), and IV in 14 (70%). The mean bilirubin level was 14.7 ± 4.9 mg/dL. Technical success was achieved in all patients, with a significant reduction in bilirubin levels (2.9 ± 1.7 mg/dL). One patient experienced cholangitis as early complication, while in 2 patients stent ingrowth was observed. No stents migration was recorded. There was no procedure-related mortality. At the end of the follow-up (7.1 ± 3.1 months), 13 of the 20 patients (65%) had died. Conclusions. Our experience confirms endoscopic bilateral self-expandable metallic stents placement with stent-in-stent technique (Y-shaped configuration) as a feasible, effective, and safe procedure for palliation of unresectable malignant hilar strictures. PMID:24790548

  6. Comparison between gastrostomy feeding and self-expandable metal stent insertion for patients with esophageal cancer and dysphagia.

    PubMed

    Min, Yang Won; Jang, Eun Young; Jung, Ji Hey; Lee, Hyuk; Min, Byung-Hoon; Lee, Jun Haeng; Rhee, Poong-Lyul; Kim, Jae J

    2017-01-01

    Self-expandable metal stent (SEMS) insertion and percutaneous gastrostomy (PG) feeding are commonly used for patients with esophageal cancer and dysphagia. This study aimed to compare outcomes between SEMS insertion and PG feeding for them. We retrospectively analyzed 308 patients with esophageal cancer who underwent fully covered SEMS insertion (stent group) or PG (gastrostomy group) for dysphagia due to tumor. Patients with other causes of dysphagia, such as radiation-induced or postoperative stricture, were excluded from the study. Clinical outcomes were compared between the two groups, including overall survival and need for additional intervention and postprocedural nutritional status. At baseline, the stent group (n = 169) had more stage IV patients, less cervical cancers, and received radiotherapy and esophagectomy less often than the gastrostomy group (n = 64). The Kaplan-Meier curves showed higher overall survival in the gastrostomy group than in the stent group. Multivariate analysis revealed that PG was associated with better survival compared with SEMS insertion (hazard ratio 0.541, 95% confidence interval 0.346-0.848, p = 0.007). In addition, the gastrostomy group needed additional intervention less often (3.1% vs. 21.9%, p < 0.001) and experienced less decrease in serum albumin levels (-0.15 ± 0.56 g/dL vs. -0.39 ± 0.58 g/dL, p = 0.011) than the stent group after procedure. Our data suggested that, compared with SEMS insertion, PG is associated with better overall survival in patients with esophageal cancer and dysphagia. Stabilized nutritional status by PG may play a role in improving patient survival.

  7. Nitinol Temperature Monitoring Devices

    DTIC Science & Technology

    1976-01-09

    AD-A021 578 NITINOL TEMPERATURE MONITORING DEVICES William J. Buehler, et al Naval Surface Weapons Center Silver Spring, Maryland 9 January 1976...LABORATORY S NITINOL TEMPERATURE MONITORING DEVICES 9 JANUARY 1976 NAVAL SURFACE WEAPONS CENTER WHITE OAK LABORATORY SILVER SPRING, MARYLAND 20910 * Approved...GOVT ACCESSION NO. 3. RECIPIIENT’S CATALOG NUMBER NSWC/WOL/TR 75-140 ____ ______ 4 TITLE (and Subtitle) 5. TYPE OF REPCRT & PERIOD COVERED Nitinol

  8. An Efficient Finite Element Framework to Assess Flexibility Performances of SMA Self-Expandable Carotid Artery Stents

    PubMed Central

    Ferraro, Mauro; Auricchio, Ferdinando; Boatti, Elisa; Scalet, Giulia; Conti, Michele; Morganti, Simone; Reali, Alessandro

    2015-01-01

    Computer-based simulations are nowadays widely exploited for the prediction of the mechanical behavior of different biomedical devices. In this aspect, structural finite element analyses (FEA) are currently the preferred computational tool to evaluate the stent response under bending. This work aims at developing a computational framework based on linear and higher order FEA to evaluate the flexibility of self-expandable carotid artery stents. In particular, numerical simulations involving large deformations and inelastic shape memory alloy constitutive modeling are performed, and the results suggest that the employment of higher order FEA allows accurately representing the computational domain and getting a better approximation of the solution with a widely-reduced number of degrees of freedom with respect to linear FEA. Moreover, when buckling phenomena occur, higher order FEA presents a superior capability of reproducing the nonlinear local effects related to buckling phenomena. PMID:26184329

  9. Carotid stenting using tapered and nontapered stents: associated neurological complications and restenosis rates.

    PubMed

    Brown, Katherine E; Usman, Asad; Kibbe, Melina R; Morasch, Mark D; Matsumura, Jon S; Pearce, William H; Amaranto, Daniel J; Eskandari, Mark K

    2009-01-01

    Self-expanding stent design systems for carotid artery stenting (CAS) have morphed from nontapered (NTS) to tapered (TS); however, the impact of this change is unknown. We reviewed the outcomes of CAS with these two broad categories of stents in a single-center retrospective review of 308 CAS procedures from May 2001 to July 2007. Nitinol self-expanding TS or NTS coupled with cerebral embolic protection devices were used to treat extracranial carotid occlusive disease. Data analysis included demographics, procedural records, duplex exams, and conventional arteriography. Mean follow-up was 18 months (range 1-69). Restenosis was defined as >or=80% in-stent carotid artery stenosis by angiography. The mean age of the entire cohort was 71.3 years (75% men, 25% women). Of the 308 cases, 233 were de novo lesions and 75 had a prior ipsilateral carotid endarterectomy (n = 44) or external beam radiation exposure (n = 31). Preprocedure neurological symptoms were present in 30% of patients. TS were used in 156 procedures and NTS in 152 procedures. The 30-day ipsilateral stroke and death rates were 1.3% and 0.3%, respectively. An additional three (1.0%) posterior circulation strokes occurred. There was no statistically significant difference in the 30-day total stroke rates between TS (3.2%, n = 5) and NTS (1.3%, n = 2) (p = 0.5). At midterm follow-up, restenosis or asymptomatic occlusion was detected in eight cases (2.6%). All occurred in arteries treated with NTS, and this was statistically different when compared to arteries treated with TS (p = 0.03). Furthermore, a post-hoc subgroup analysis revealed significant correlation (chi(2) = 0.02) for restenosis in "hostile necks" when separated by TS vs. NTS. Early CAS outcomes between TS and NTS are comparable. In contrast, self-expanding nitinol TS may have a lower incidence of significant restenosis or asymptomatic occlusion when compared to NTS.

  10. Esophageal stent fracture: Case report and review of the literature

    PubMed Central

    Khara, Harshit S; Diehl, David L; Gross, Seth A

    2014-01-01

    Endoscopic esophageal stent placement is widely used in the treatment of a variety of benign and malignant esophageal conditions. Self expanding metal stents (SEMS) are associated with significantly reduced stent related mortality and morbidity compared to plastic stents for treatment of esophageal conditions; however they have known complications of stent migration, stent occlusion, tumor ingrowth, stricture formation, reflux, bleeding and perforation amongst others. A rare and infrequently reported complication of SEMS is stent fracture and subsequent migration of the broken pieces. There have only been a handful of published case reports describing this problem. In this report we describe a case of a spontaneously fractured nitinol esophageal SEMS, and review the available literature on the unusual occurrence of SEMS fracture placed for benign or malignant obstruction in the esophagus. SEMS fracture could be a potentially dangerous event and should be considered in a patient having recurrent dysphagia despite successful placement of an esophageal SEMS. It usually requires endoscopic therapy and may unfortunately require surgery for retrieval of a distally migrated fragment. Early recognition and prompt management may be able to prevent further problems. PMID:24627608

  11. Esophageal stent fracture: case report and review of the literature.

    PubMed

    Khara, Harshit S; Diehl, David L; Gross, Seth A

    2014-03-14

    Endoscopic esophageal stent placement is widely used in the treatment of a variety of benign and malignant esophageal conditions. Self expanding metal stents (SEMS) are associated with significantly reduced stent related mortality and morbidity compared to plastic stents for treatment of esophageal conditions; however they have known complications of stent migration, stent occlusion, tumor ingrowth, stricture formation, reflux, bleeding and perforation amongst others. A rare and infrequently reported complication of SEMS is stent fracture and subsequent migration of the broken pieces. There have only been a handful of published case reports describing this problem. In this report we describe a case of a spontaneously fractured nitinol esophageal SEMS, and review the available literature on the unusual occurrence of SEMS fracture placed for benign or malignant obstruction in the esophagus. SEMS fracture could be a potentially dangerous event and should be considered in a patient having recurrent dysphagia despite successful placement of an esophageal SEMS. It usually requires endoscopic therapy and may unfortunately require surgery for retrieval of a distally migrated fragment. Early recognition and prompt management may be able to prevent further problems.

  12. Endoscopic transluminal pancreatic necrosectomy using a self-expanding metal stent and high-flow water-jet system

    PubMed Central

    Hritz, István; Fejes, Roland; Székely, András; Székely, Iván; Horváth, László; Sárkány, Ágnes; Altorjay, Áron; Madácsy, László

    2013-01-01

    Walled-off pancreatic necrosis and a pancreatic abscess are the most severe complications of acute pancreatitis. Surgery in such critically ill patients is often associated with significant morbidity and mortality within the first few weeks after the onset of symptoms. Minimal invasive approaches with high success and low mortality rates are therefore of considerable interest. Endoscopic therapy has the potential to offer safe and effective alternative treatment. We report here on 3 consecutive patients with infected walled-off pancreatic necrosis and 1 patient with a pancreatic abscess who underwent direct endoscopic necrosectomy 19-21 d after the onset of acute pancreatitis. The infected pancreatic necrosis or abscess was punctured transluminally with a cystostome and, after balloon dilatation, a non-covered self-expanding biliary metal stent was placed into the necrotic cavity. Following stent deployment, a nasobiliary pigtail catheter was placed into the cavity to ensure continuous irrigation. After 5-7 d, the metal stent was removed endoscopically and the necrotic cavity was entered with a therapeutic gastroscope. Endoscopic debridement was performed via the simultaneous application of a high-flow water-jet system; using a flush knife, a Dormia basket, and hot biopsy forceps. The transluminal endotherapy was repeated 2-5 times daily during the next 10 d. Supportive care included parenteral antibiotics and jejunal feeding. All patients improved dramatically and with resolution of their septic conditions; 3 patients were completely cured without any further complications or the need for surgery. One patient died from a complication of prolonged ventilation severe bilateral pneumonia, not related to the endoscopic procedure. No procedure related complications were observed. Transluminal endoscopic necrosectomy with temporary application of a self-expanding metal stent and a high-flow water-jet system shows promise for enhancing the potential of this endoscopic

  13. Endoscopic transluminal pancreatic necrosectomy using a self-expanding metal stent and high-flow water-jet system.

    PubMed

    Hritz, István; Fejes, Roland; Székely, András; Székely, Iván; Horváth, László; Sárkány, Agnes; Altorjay, Aron; Madácsy, László

    2013-06-21

    Walled-off pancreatic necrosis and a pancreatic abscess are the most severe complications of acute pancreatitis. Surgery in such critically ill patients is often associated with significant morbidity and mortality within the first few weeks after the onset of symptoms. Minimal invasive approaches with high success and low mortality rates are therefore of considerable interest. Endoscopic therapy has the potential to offer safe and effective alternative treatment. We report here on 3 consecutive patients with infected walled-off pancreatic necrosis and 1 patient with a pancreatic abscess who underwent direct endoscopic necrosectomy 19-21 d after the onset of acute pancreatitis. The infected pancreatic necrosis or abscess was punctured transluminally with a cystostome and, after balloon dilatation, a non-covered self-expanding biliary metal stent was placed into the necrotic cavity. Following stent deployment, a nasobiliary pigtail catheter was placed into the cavity to ensure continuous irrigation. After 5-7 d, the metal stent was removed endoscopically and the necrotic cavity was entered with a therapeutic gastroscope. Endoscopic debridement was performed via the simultaneous application of a high-flow water-jet system; using a flush knife, a Dormia basket, and hot biopsy forceps. The transluminal endotherapy was repeated 2-5 times daily during the next 10 d. Supportive care included parenteral antibiotics and jejunal feeding. All patients improved dramatically and with resolution of their septic conditions; 3 patients were completely cured without any further complications or the need for surgery. One patient died from a complication of prolonged ventilation severe bilateral pneumonia, not related to the endoscopic procedure. No procedure related complications were observed. Transluminal endoscopic necrosectomy with temporary application of a self-expanding metal stent and a high-flow water-jet system shows promise for enhancing the potential of this endoscopic

  14. In Vitro Hemocompatibility of Thin Film Nitinol In Stenotic Flow Conditions

    PubMed Central

    Kealey, C.P.; Whelan, S.A.; Chun, Y.J.; Soojung, C.H.; Tulloch, A.W.; Mohanchandra, K.P.; DiCarlo, D; Levi, D.S.; Carman, G.P.; Rigberg, D.A.

    2010-01-01

    Because of its low profile and biologically inert behavior, thin film nitinol (TFN) is ideally suited for use in construction of endovascular devices. We have developed a surface treatment for TFN designed to minimize platelet adhesion by creating a super-hydrophilic surface. The hemocompatibility of expanded polytetrafluorethylene (ePTFE), untreated thin film nitinol (UTFN), and a surface treated superhydrophilic thin film nitinol (STFN) was compared using an in vitro circulation model with whole blood under flow conditions simulating a moderate arterial stenosis. Scanning electron microscopy analysis showed increased thrombus on ePTFE as compared to UTFN or STFN. Total blood product deposition was 6.3 ± 0.8 mg/cm2 for ePTFE, 4.5 ± 2.3 mg/cm2 for UTFN, and 2.9 ± 0.4 mg/cm2 for STFN (n = 12, p < 0.01). ELISA assay for fibrin showed 326 ± 42 µg/cm2 for ePTFE, 45.6 ± 7.4 µg/cm2 for UTFN, and 194 ± 25 µg/cm2 for STFN (n = 12, p < 0.01). Platelet deposition measured by fluorescent intensity was 79,000 ± 20000 AU/mm2 for ePTFE, 810 ± 190 AU/mm2 for UTFN, and 1600 ± 25 AU/mm2 for STFN (n = 10, p < 0.01). Mass spectrometry demonstrated a larger number of proteins on ePTFE as compared to either thin film. UTFN and STFN appear to attract significantly less thrombus than ePTFE. Given TFN's low profile and our previously demonstrated ability to place TFN covered stents in vivo, it is an excellent candidate for use in next-generation endovascular stents grafts. PMID:20810163

  15. The intrinsically high pitting corrosion resistance of mechanically polished nitinol in simulated physiological solutions.

    PubMed

    Bai, Zhijun; Rotermund, Harm H

    2011-10-01

    Nitinol wires have been widely used in many biomedical applications, such as cardiovascular stent due to their superelasticity and shape memory effect. However, their corrosion properties and the related biocompatibility are not well understood, and the reported results are controversial. In this study, we evaluate the pitting corrosion property of nitinol, titanium, nickel, and 316L stainless steel (316LSS) wires with different surface roughnesses in a saline solution at 37 °C. The cyclic potentiodynamic polarization results show that mechanically polished nitinol and Ti wires are highly resistant to pitting corrosion, while Ni and 316LSS wires are susceptible to pitting corrosion. Electrochemical impedance spectroscopy is used to study the interface of oxide film/solution and all mechanically polished nitinol wires are covered by 2-3 nm thick films formed under open circuit potential. Furthermore, the electronic structures and semiconducting properties of passive films on nitinol, Ti and Ni wires are studied by Mott-Schottky analysis. Passive films formed on nitinol and Ti exhibit n-type semiconducting characteristics, whereas films on Ni show p-type semiconducting characteristics. Scanning Kelvin Microscopy is used to measure the surface potential difference between common inclusions from the nitinol matrix and the results indicate that the inclusions are more electrochemically noble than the nitinol matrix. Band energy theory is used to model the electrochemical interface between the passive films of nitinol and the solution under different applied potential conditions. A mechanism for the strong pitting corrosion resistance of nitinol in saline solution is proposed.

  16. Placement of a new fully covered self-expanding metal stent for postoperative biliary strictures and leaks not responding to plastic stenting.

    PubMed

    Luigiano, Carmelo; Bassi, Marco; Ferrara, Francesco; Fabbri, Carlo; Ghersi, Stefania; Morace, Carmela; Consolo, Pierluigi; Maimone, Antonella; Galluccio, Gabriella; D'Imperio, Nicola; Cennamo, Vincenzo

    2013-04-01

    Fully covered self-expanding metal stents (FCSEMSs) are now being used to treat postoperative biliary strictures (BSs) and biliary leaks (BLs). The aim of this study was to assess the safety and effectiveness of a new FCSEMS (Wallflex) in patients with postoperative BSs and BLs after failure of traditional endoscopic treatment. Between January 2010 and December 2011, 16 patients (10 patients with postcholecystectomy BSs, 4 with postcholecystectomy BLs, and 2 with postorthotopic liver transplantation BSs) were enrolled. The technical and clinical success rate was 100%. All FCSEMSs were removed after a mean of 141 days. Complications occurred in 7 cases: 2 postprocedure pain, 2 mild pancreatitis, 1 early distal, and 2 late proximal FCSEMS migration. The overall long-term clinical success rate was 94% after a mean follow-up of 13 months. In our experience, the placement of FCSEMSs is an effective and secure method of treating refractory postoperative BSs or BLs.

  17. In-Graft Endovascular Stenting Repair for Supravalvular Stenosis From Aortic Rupture After Balloon-Expanding Transcatheter Aortic Valve Implantation.

    PubMed

    Furukawa, Nobuyuki; Scholtz, Werner; Haas, Nikolaus; Ensminger, Stephan; Gummert, Jan; Börgermann, Jochen

    2015-01-01

    An 81-year-old man with high-grade aortic valve stenosis and status post-coronary artery bypass grafting and supracoronary replacement of the ascending aorta was referred for transcatheter aortic valve implantation. He was in New York Heart Association class III and had dyspnea. After appropriate screening, we implanted a 29-mm SAPIEN XT valve (Edwards Lifesciences, Irvine, CA USA) through a transapical approach because of severe peripheral arterial occlusive disease. Postinterventional aortography revealed correct positioning and function of the valve and free coronary ostia but contrast extravasation in the vicinity of the interposed vascular prosthesis, resulting in severe luminal narrowing. We chose to manage the stenosis with an endovascular stent. After stenting, extravascular compression was markedly reduced, and the pressure gradient disappeared. The patient was discharged home on the 20th postoperative day. Three months later, computed tomography depicted correct positioning of both grafts. The patient's general health is good, and he is now in New York Heart Association class II. This case illustrates a complication of transcatheter aortic valve implantation specific for patients with an ascending aortic graft. Although stenting may be a good solution, as depicted by this case, self-expanding transcatheter aortic valves should be preferred in patients with ascending aortic grafts to avoid the described complication.

  18. Carotid artery stenting: which stent for which lesion?

    PubMed

    Bosiers, Marc; Deloose, Koen; Verbist, Jürgen; Peeters, Patrick

    2005-01-01

    The different geometries and working principles of carotid stents (nitinol or cobalt chromium, open- or closed-cell configuration) provide each product with unique functional properties. The individual characteristics of each device may make it an attractive choice in one circumstance but render it less desirable in other situations. In approximately 75% of all procedures, all types of stents will achieve similar outcomes, making adequate device selection unnecessary. For the remaining quarter, careful preoperative screening is mandatory. In addition to eventual access issues, the choice of the optimal carotid stent depends mainly on arterial anatomy and lesion morphology. When treating a tortuous anatomy, stents with a flexible and comformable open-cell configuration are preferred. In arteries with a significant mismatch between common carotid artery and internal carotid artery diameter, cobalt chromium (Elgiloy) or tapered nitinol stents are selected. Lesions with suspected high emboligenicity are best covered with stents with a closed-cell configuration, whereas highly calcified lesions need treatment with nitinol stents. Thorough knowledge of the characteristics, advantages and disadvantages, and working principles of the different available stents is mandatory to optimally select the materials to be used for patients eligible for carotid revascularization.

  19. Self expandable stents for relief of venous baffle obstruction after the Mustard operation.

    PubMed

    Brown, S C; Eyskens, B; Mertens, L; Stockx, L; Dumoulin, M; Gewillig, M

    1998-03-01

    Obstruction of the venous pathways after Mustard repair for transposition of the great arteries is associated with an increased risk of arrhythmia and sudden death. The purpose of this study was to assess the effectiveness of the largest (tracheal 22 x 40 mm) Wallstents in treating baffle obstructions. Retrospective analysis of patients with stented venous pathways. Eleven patients with baffle obstruction after Mustard repair for transposition of the great arteries. Stenoses were dilated with an 18 or 20 mm balloon. However, recoil was noticed in 11 patients: immediately (n = 7) or on repeat angiography (n = 4). Eighteen stents were implanted (mean (SD)) 18 (3.3) years postoperatively. After dilatation a tracheal Wallstent (11.5 F) was deployed. Relief of obstruction, haemodynamic improvement. In the inferior vena cava, 10 stents were deployed in seven baffle obstructions with an increase in diameter from 9.8 (2.4) mm to 16.5 (1.4) mm (p < 0.01) and a mean (SD) pressure gradient decrease from 5.1 (3.6) mm Hg to 1.4 (2.0) mm Hg; in the superior vena cava, eight stents were implanted increasing the diameter from 9.1 (3.7) mm to 15.6 (3.8) mm (p < 0.001) with a decrease in mean pressure gradient from 5.1 (2.7) mm Hg to 1.9 (1.5) mm Hg. No complications were experienced during implantation. No anticoagulation was prescribed. During follow up (1.7 (0.6) years; range, 0.9-2.6) no problems were noted; five patients were re-catheterised without change in measurements. There was no evidence of peal formation in any of the stents. It is concluded that Wallstents are safe, easy to use, and effective in relieving baffle obstruction. Anticoagulation does not seem necessary.

  20. 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.

  1. Role of Stent Grafts and Helical-Woven Bare-Metal Stents in the Superficial Femoral and Popliteal Arteries.

    PubMed

    Madassery, Sreekumar; Turba, Ulku C; Arslan, Bulent

    2016-06-01

    Peripheral vascular disease (PVD) is a devastating medical problem that may lead to significant life alterations for patients, from simply limiting their daily activities to potential loss of limbs and eventual demise. Superficial femoral and popliteal arteries are significantly common locations for PVD sequelae to present itself, and owing to their length and mobile nature, treatment of these segments are quite challenging. Indications for PVD treatment include lifestyle-limiting claudication that is not responding to medical management, ischemic rest pain, nonhealing ulcers, and lower extremity gangrene. There is a wide variety of treatment options that include medical management, interventional, and surgical techniques. Interventional techniques include plain old balloon angioplasty, cryoplasty, drug-coated balloon angioplasty, self-expanding bare-nitinol stents, self-expanding covered stents, self-expanding drug-eluding stents, and a number of atherectomy devices (ie, laser, rotational, orbital, and excisional). The scope of this article is to review indications, patient selection, and deployment techniques of Viabahn and Supera self-expanding stents. Copyright © 2016 Elsevier Inc. All rights reserved.

  2. Plastic vs. Self-Expandable Metal Stents for Palliation in Malignant Biliary Obstruction: A Series of Meta-Analyses.

    PubMed

    Almadi, Majid A; Barkun, Alan; Martel, Myriam

    2017-02-01

    Self-expandable metal stents (SEMS) are thought to have an advantage over plastic stents in achieving biliary drainage. We performed a systematic search of MEDLINE, EMBASE, Scopus, CENTRAL, and ISI Web of knowledge databases, from January 1980 to September 2015, for randomized-controlled trials (RCTs) comparing SEMS vs. plastic stents in the palliation of malignant biliary obstruction. Primary outcomes were durations of stent patency, patient survival, and 30-day mortality. Numerous secondary outcomes were assessed, and extensive sensitivity and subgroup analyses were performed. In all, 20 RCTs totaling 1,713 patients yielded a weighted mean difference (WMD) in time to stent patency (4 studies) of 4.45 months (95% confidence interval (CI), 0.31, 8.59; GRADE=moderate) favoring SEMS. There were no differences in overall patient survival (5 studies) WMD=0.67 months (95% CI, -0.66, 1.99; GRADE=moderate), or 30-day mortality (8 studies) odds ratio (OR)=0.80 (95% CI, 0.52, 1.24; GRADE=moderate) but there was a higher symptom-free survival at 6 months (4 studies) OR=5.96 (95% CI, 1.71, 20.81; GRADE=moderate). SEMS use resulted in lower rates of late complications (11 studies) OR=0.43 (95% CI, 0.26, 0.71; GRADE=moderate), sepsis or cholangitis (14 studies) OR=0.53 (95% CI, 0.37, 0.77; GRADE=high), blocking from sludge (8 studies) OR=0.11(95% CI, 0.07, 0.17; GRADE=moderate), and mean number of re-interventions (8 studies) WMD=-0.83 interventions (95% CI, -1.64, -0.02; GRADE=moderate). There was a longer patency of SEMS for those without a prior drainage attempt (2 studies) WMD 7.70 months (95% CI, 7.14, 8.25; GRADE=high). Although a survival advantage was found when an uncovered SEMS was used (3 studies) WMD 1.31 months (95% CI, 0.30, 2.32; GRADE=high), but not partially or fully covered SEMS (2 studies) WMD -0.66 months (95% CI, -1.02, -0.30; GRADE=high) vs. plastic stents, and for SEMS in the setting of pre- or post-procedural antibiotic administration (2 studies) WMD 1

  3. 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.

  4. Antireflux versus conventional self-expanding metallic Stents (SEMS) for distal esophageal cancer: results of a multicenter randomized trial

    PubMed Central

    Coron, E.; David, G.; Lecleire, S.; Jacques, J.; Le Sidaner, A.; Barrioz, T.; Coumaros, D.; Volteau, C.; Vedrenne, B.; Bichard, P.; Boustière, C.; Touchefeu, Y.; Brégeon, J.; Prat, F.; Le Rhun, M.

    2016-01-01

    Introduction: Self-expanding metal stents (SEMS) are commonly used in the palliation of dysphagia in patients with inoperable esophageal carcinoma. However, they predispose to gastroesophageal reflux when deployed across the gastroesophageal junction. The aims of this study were to: 1) assess the influence of the antireflux valve on trans-prosthetic reflux (primary outcome); and 2) compare the results of SEMS with and without antireflux valve in terms of reflux symptoms, quality of life (QOL), improvement of dysphagia and adverse events (secondary outcomes). Patients and methods: Thirty-eight patients were enrolled in nine centers. Carcinomas were locally advanced (47 %) or metastatic. After randomization, patients received either a covered SEMS with antireflux valve (n = 20) or a similar type of SEMS with no antireflux device but assigned to standard proton pump inhibitor therapy and postural advice (n = 18). Trans-prosthetic reflux was assessed at day 2 using a radiological score based on barium esophagography performed after Trendelenburg maneuver and graded from 0 (no reflux) to 12 (maximum). Monthly telephone interviews were conducted for Organisation Mondiale de la Santé (OMS) scoring from 0 (excellent) to 5 (poor), QOL assessment (based on the Reflux-Qual Simplifié scoring system) from 0 (poor) to 100 (excellent), dysphagia scoring from 0 (no dysphagia) to 5 (complete dysphagia) and regurgitation scoring from 0 (no regurgitation) to 16 (maximum). Results: No difference was noted in terms of age, sex, size of lesion, prosthesis length or need for dilation prior to SEMS placement. No difficulty in placing SEMS nor complications were noted. Radiological scores of reflux were found to be significantly lower in patients with an antireflux stent compared to the conventional stent and associated measures. The regurgitation scores were significantly decreased in patients with antireflux stents during the first 2 months after stent placement and

  5. Self expandable stents for relief of venous baffle obstruction after the Mustard operation

    PubMed Central

    Brown, S; Eyskens, B; Mertens, L; Stockx, L; Dumoulin, M; Gewillig, M

    1998-01-01

    Objective—Obstruction of the venous pathways after Mustard repair for transposition of the great arteries is associated with an increased risk of arrhythmia and sudden death. The purpose of this study was to assess the effectiveness of the largest (tracheal 22 × 40 mm) Wallstents in treating baffle obstructions.
Design—Retrospective analysis of patients with stented venous pathways.
Subjects—Eleven patients with baffle obstruction after Mustard repair for transposition of the great arteries.
Interventions—Stenoses were dilated with an 18 or 20 mm balloon. However, recoil was noticed in 11 patients: immediately (n = 7) or on repeat angiography (n = 4). Eighteen stents were implanted (mean (SD)) 18 (3.3) years postoperatively. After dilatation a tracheal Wallstent (11.5 F) was deployed.
Main outcome measures—Relief of obstruction, haemodynamic improvement.
Results—In the inferior vena cava, 10 stents were deployed in seven baffle obstructions with an increase in diameter from 9.8 (2.4) mm to 16.5 (1.4) mm (p < 0.01) and a mean (SD) pressure gradient decrease from 5.1 (3.6) mm Hg to 1.4 (2.0) mm Hg; in the superior vena cava, eight stents were implanted increasing the diameter from 9.1 (3.7) mm to 15.6 (3.8) mm (p < 0.001) with a decrease in mean pressure gradient from 5.1 (2.7) mm Hg to 1.9 (1.5) mm Hg. No complications were experienced during implantation. No anticoagulation was prescribed. During follow up (1.7 (0.6) years; range, 0.9-2.6) no problems were noted; five patients were re-catheterised without change in measurements. There was no evidence of peal formation in any of the stents.
Conclusion—It is concluded that Wallstents are safe, easy to use, and effective in relieving baffle obstruction. Anticoagulation does not seem neccessary.

 Keywords: Mustard procedure;  venous baffle obstruction;  stent PMID:9602654

  6. Fully covered, self-expandable metal stents for first-step endoscopic treatment of biliary leaks secondary to hepato-biliary surgery: a retrospective study.

    PubMed

    Mangiavillano, Benedetto; Luigiano, Carmelo; Tarantino, Ilaria; Barresi, Luca; Dinelli, Marco; Frego, Roberto; Bassi, Marco; Fabbri, Carlo; Cennamo, Vincenzo; Viaggi, Paolo; Traina, Mario; Santoro, Tara; Masci, Enzo

    2013-05-01

    Fully covered self-expanding metal stents are now being used to treat benign biliary diseases. To assess the outcomes of these stents as first-step therapy in patients with biliary leaks secondary to hepato-biliary surgery. Thirty patients (56.7% males; mean age: 60.2 ± 13 years) were retrospectively evaluated. The data collected included technical and clinical success, adverse events and follow-up findings (1, 3 and 6 months). Technical and clinical success rates were 100%. One early mild post-procedure pancreatitis occurred and resolved spontaneously. Three late stent distal migrations occurred, however cholangiography showed correct leak sealing in all patients. Stents were removed after a mean of 55.9 days. During follow-up no other complications occurred. In our experience fully covered self-expanding metal stent placement was safe and efficacious as first-step therapy for post-operative biliary leaks. However, prospective comparative studies with plastic stents are required to validate these findings. Copyright © 2012 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

  7. A comparison of the temporary placement of 3 different self-expanding stents for the treatment of refractory benign esophageal strictures: a prospective multicentre study

    PubMed Central

    2012-01-01

    Background Refractory benign esophageal strictures (RBESs) have been treated with the temporary placement of different self-expanding stents with conflicting results. We compared the clinical effectiveness of 3 types of stents: self-expanding plastic stents (SEPSs), biodegradable stents, and fully covered self-expanding metal stents (FCSEMSs), for the treatment of RBES. Methods This study prospectively evaluated 3 groups of 30 consecutive patients with RBESs who underwent temporary placement of either SEPSs (12 weeks, n = 10), biodegradable stents (n = 10) or FCSEMSs (12 weeks, n = 10). Data were collected to analyze the technical success and clinical outcome of the stents as evaluated by recurrent dysphagia, complications and reinterventions. Results Stent implantation was technically successful in all patients. Migration occurred in 11 patients: 6 (60%) in the SEPS group, 2 (20%) in the biodegradable group and 3 (30%) in the FCSEMS group (P = 0.16). A total of 8/30 patients (26.6%) were dysphagia-free after the end of follow-up: 1 (10%) in the SEPS group, 3 (30%) in the biodegradable group and 4 (40%) in the FCSEMS group (P = 0.27). More reinterventions were required in the SEPS group (n = 24) than in the biodegradable group (n = 13) or the FCSEMS group (n = 13) (P = 0.24). Multivariate analysis showed that stricture length was significantly associated with higher recurrence rates after temporary stent placement (HR = 1.37; 95% CI = 1.08-1.75; P = 0.011). Conclusions Temporary placement of a biodegradable stent or of a FCSEMS in patients with RBES may lead to long-term relief of dysphagia in 30 and 40% of patients, respectively. The use of SEPSs seems least preferable, as they are associated with frequent stent migration, more reinterventions and few cases of long-term improvement. Additionally, longer strictures were associated with a higher risk of recurrence. PMID:22691296

  8. Self-expanding metal stents for the palliation of malignant gastric outlet obstruction in patients with peritoneal carcinomatosis

    PubMed Central

    Rademacher, Christoph; Bechtler, Matthias; Schneider, Steffen; Hartmann, Bettina; Striegel, Johannes; Jakobs, Ralf

    2016-01-01

    AIM To evaluate the efficacy of self-expanding metal stents (SEMS) for the palliation of malignant gastric outlet obstruction in patients with and without peritoneal carcinomatosis (PC). METHODS We performed a retrospective analysis of 62 patients who underwent SEMS placement for treatment of malignant gastroduodenal obstruction at our hospital over a six-year period. Stents were deployed through the scope under combined fluoroscopic and endoscopic guidance. Technical success was defined as successful stent placement and expansion. Clinical success was defined as an improvement in the obstructive symptoms and discharge from hospital without additional parenteral nutrition. According to carcinomatosis status, patients were assigned into groups with or without evidence of peritoneal disease. RESULTS In most cases, obstruction was caused by pancreatic (47%) or gastric cancer (23%). Technical success was achieved in 96.8% (60/62), clinical success in 79% (49/62) of all patients. Signs of carcinomatosis were identified in 27 patients (43.5%). The diagnosis was confirmed by pathology or previous operation in 7 patients (11.2%) and suspected by CT, MRI or ultrasound in 20 patients (32.2%). Presence of carcinomatosis was associated with a significantly lower clinical success rate compared to patients with no evidence of peritoneal disease (66.7% vs 88.6%, P = 0.036). There was no significant difference in overall survival between patients with or without PC (median 48 d vs 70 d, P = 0.21), but patients showed significantly longer survival after clinical success of SEMS placement compared to those experiencing clinical failure (median 14.5 d vs 75 d, P = 0.0003). CONCLUSION Given the limited therapeutic options and a clinical success rate of at least 66.7%, we believe that SEMS are a reasonable treatment option in patients with malignant gastric outlet obstruction with peritoneal carcinomatosis. PMID:27920476

  9. Effect of Early Use of Covered Self-Expandable Endoscopic Stent on the Treatment of Postoperative Stapler Line Leaks.

    PubMed

    Quezada, Nicolás; Maiz, Cristóbal; Daroch, David; Funke, Ricardo; Sharp, Allan; Boza, Camilo; Pimentel, Fernando

    2015-10-01

    Postoperative leaks are a dreaded complication after bariatric surgery (BS). Its treatment is based on nutritional support and sepsis control by antibiotics, collections drainage and/or prosthesis, and/or surgery. The aim of this study is to report our experience with coated self-expandable endoscopic stents (SEES) for leaks treatment. This study was performed in a University Hospital, (censored). We performed a retrospective analysis of our BS database from January 2007 to December 2013. All patients with leak after BS treated with SEES were included. We identified 29 patients; 17 (59%) were women, with median age of 37 (19-65) years, and preoperative body mass index of 40 (28.7-56-6) kg/m(2). Nineteen (65.5%) patients had a sleeve gastrectomy and 10 (34.5%) a Roux-en-Y gastric bypass. All patients had a leak in the stapler line. Median time from surgery to leak diagnosis was 7 (1-51) days, and SEES were installed 8 (0-104) days after diagnosis. Twenty-one (72%) patients also had abdominal exploration. Median length of SEES use was 60 (1-299) days. Patients who had SEES as primary treatment (with or without simultaneous reoperation) had a shorter leak closure time (50 [6-112] vs 109 [60-352] days; p = 0.008). Twenty-eight (96.5%) patients successfully achieved leak closure with SEES. There were 16 migrations in 10 (34%) patients, 1 (3%) stent fracture, 1 opening of the blind end of alimentary limb (3%), and 5 patients (17%) required a second stent due to leak persistence. SEES is a feasible, safe, and effective management of post BS leaks, although patients may also require prosthesis revision and abdominal exploration. Primary SEES placement is associated with a shorter leak resolution time.

  10. Salvage therapy using self-expandable metal stents for recalcitrant anastomotic strictures after living-donor liver transplantation

    PubMed Central

    Jang, Sung Ill; Sung, Se Yong; Park, Hyunsung; Lee, Kwang-Hun; Joo, Seung-Moon; Lee, Dong Ki

    2017-01-01

    Background: Recently, there has been an increase in clinical success rates using nonsurgical methods to resolve anastomotic biliary strictures (ABSs) that develop after liver transplantation (LT). However, some strictures are particularly refractory and cannot be completely resolved by an endoscopic or percutaneous procedure. Consequently, the aim of this study was to examine the feasibility and efficacy of using a newly designed fully covered self-expandable metal stent (FCSEMS) to resolve refractory ABS. Methods: A total of 35 patients with an ABS that developed after LT, but could not be resolved by an endoscopic or percutaneous procedure, were included in this study. FCSEMSs were positioned endoscopically and removed after 2–3 months. After stent removal, the patients were followed to assess complications, including re-stenosis. Results: The mean period from LT to stricture was 13.7 months, and the mean duration of the stricture was 31.8 months. The type and mean number of procedures previously attempted were endoscopic retrograde cholangiopancreatography (ERCP) (9.1 ± 5.1) in 19 patients and percutaneous transhepatic biliary drainage (9.2 ± 4.8) in 16 patients. All patients had successful FCSEMS insertions and removals; the mean stent indwelling time was 3.2 months. The mean follow-up period was 18.7 months (range: 6.4–37.8 months). Stricture recurrence was observed in 6 of 29 patients (recurrence rate: 20.7%). The anastomotic stricture resolved with the FCSEMS insertion in 29 of 35 patients (clinical success rate: 82.9%). Conclusions: The newly designed FCSEMS is a potentially feasible and effective treatment for anastomotic strictures that develop after LT but are not amenable to treatment by conventional procedures. PMID:28246547

  11. Surface modifications of nitinol.

    PubMed

    Haider, Waseem; Munroe, N; Tek, V; Pulletikurthi, C; Gill, P K S; Pandya, S

    2009-01-01

    Nitinol (an acronym for the Nickel-Titanium Naval Ordnance Laboratory) has been extensively explored as an implant material for the medical industry. The potential problem with Nitinol implant devices is the release of Ni in the human body, which has stimulated a great deal of research on surface modifications and the application of coatings. This paper presents a comprehensive review of various treatments to modify the surface of Nitinol in an effort to inhibit Ni release and to render improved biocompatibility. We discuss the important in-service properties of Nitinol, such as biocompatibility, corrosion resistance, stability, uniformity, and the nature of passivating oxides produced by passivation, electropolishing, magnetoelectropolishing, ion beam implantation, sterilization, and artificial coatings.

  12. Reocclusion after Self-Expandable Metallic Stent Placement for Relieving Malignant Colorectal Obstruction as a Palliative Treatment

    PubMed Central

    Nitta, Toshikatsu; Fujii, Kensuke; Hirata, Yoshimasa; Tominaga, Tomo; Inoue, Yoshihiro; Kawasaki, Hiroshi; Kawakami, Ken; Ishibashi, Takashi

    2016-01-01

    Self-expandable metallic stent (SEMS) placement has been practiced in several hospitals in Japan, including ours, since January 2012. Here, we report the case of an 82-year-old Japanese man who presented to the hospital with a 1-week history of right hypochondrial pain. Computed tomography (CT) findings indicated colorectal cancer. The laboratory findings on admission indicated severe anemia (red blood cell count, 426 × 104/μL; hemoglobin, 7.9 g/dL). We performed SEMS placement because the patient refused to undergo surgery. He did not attend any of the scheduled follow-up visits after SEMS placement. However, a year and a half after the SEMS placement, the patient attended the hospital because of difficulty in passing stool. A plain abdominal CT scan showed bowel reobstruction due to the ascending colon cancer after SEMS placement. We performed an emergency operation, ascending colostomy, on the same day. Colorectal stent placement may be a good treatment option for patients who refuse to undergo conventional therapeutic treatments or in those with unresectable colorectal cancer. Patients should be carefully followed up every few months after SEMS placement because of the risk of reocclusion. PMID:28100994

  13. TIPS for refractory ascites: a 6-year single-center experience with expanded polytetrafluoroethylene-covered stent-grafts.

    PubMed

    Bercu, Zachary L; Fischman, Aaron M; Kim, Edward; Nowakowski, F Scott; Patel, Rahul S; Schiano, Thomas D; Chang, Charissa Y; Lookstein, Robert A

    2015-03-01

    OBJECTIVE. This single-center study evaluated the use of expanded polytetrafluoroethylene (ePTFE)-covered stent-grafts for transjugular intrahepatic portosystemic shunt (TIPS) placement to manage portal hypertension-related refractory ascites. MATERIALS AND METHODS. One hundred patients at a single tertiary care center in a major metropolitan hospital underwent TIPS placement with an ePTFE-covered stent-graft (Viatorr TIPS Endoprosthesis). Patients with portal hypertension-related ascites and preexisting hepatocellular carcinoma or liver transplant were excluded from the analysis. Records were reviewed for demographic characteristics, technical success of the TIPS procedures, and stent follow-up findings. Clinical results were assessed at 90- and 180-day intervals. RESULTS. Immediate technical success of the TIPS procedure was 100%. Of the 61 patients with documented follow-up, 55 (90.2%) had a partial or complete ascites response to TIPS creation. Of these 55 patients, nine experienced severe encephalopathy. Six of 61 patients (9.8%) did not experience a significant ascites response. Overall survival was 78.7% at 365-day follow-up. The 365-day survival was 84.2% for patients with a model for end-stage liver disease (MELD) score of less than 15, 67.0% for those with a score of 15-18, and 53.8% for those with a score of greater than 18 (p = 0.01). For patients with a MELD score of less than 18, the 365-day survival was 88.0% for those with an albumin value of 3 mg/dL or greater and 72.8% for those with an albumin value of less than 3 mg/dL (p = 0.04). CONCLUSION. TIPS placement using an ePTFE-covered stent-graft is an efficacious therapy for refractory ascites. Patients with preserved liver function-characterized by a MELD score of less than 15 or a MELD score of less than 18 and an albumin value of 3 mg/dL or greater-experience the greatest survival benefit.

  14. 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

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

    PubMed

    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.

  16. Memokath Stent Failure in Recurrent Bulbar Urethral Strictures: Results From an Investigative Pilot Stage 2A Study.

    PubMed

    Barbagli, Guido; Rimondi, Claudio; Balò, Sofia; Butnaru, Denis; Sansalone, Salvatore; Lazzeri, Massimo

    2017-09-01

    To evaluate the efficacy of the Memokath stent in managing recurrent bulbar urethral strictures. This is an investigative pilot stage 2A study in patients with a recurrent bulbar urethral stricture who underwent a Memokath stent implant from January 2014 to January 2016 in a single high-volume center for urethral reconstruction. The Memokath stent (Pnn Medical A/S, Kvistgaard, Denmark) was manufactured from nitinol, a biocompatible alloy of nickel and titanium, which was endoscopically placed. It had a 24-Fr outside diameter and was preloaded on a disposable delivery device. When correctly positioned, the stent was anchored by a warm water (55°C) instillation, which expanded the proximal end of the stent from 24 to 42 Fr .The stent was provided in lengths of 3-7 cm in 1-cm increments. Sixteen patients were included in the study. The median follow-up was 16 months. In 7 patients (43.7%), the stent was removed within 1 year. The main adverse events were pain, encrustations, stones, and recurrent strictures. Four patients (25%) were considered a success and 12 (75%) were failures. Study limitations include the small sample. The Memokath stent was deemed to be not clinically helpful and had significant side effects, and therefore should not be considered a treatment option for men with bulbar urethral strictures. Copyright © 2017 Elsevier Inc. All rights reserved.

  17. Overview of the 2011 food and drug administration's circulatory system devices panel of the medical devices advisory committee meeting on the Zilver® PTX® drug-eluting peripheral stent.

    PubMed

    Dvir, Danny; Torguson, Rebecca; Waksman, Ron

    2012-01-01

    Zilver® PTX® (Cook Medical, Bloomington, IN) is a self-expanding nitinol drug-eluting stent with a polymer-free paclitaxel coating on its outer surface. The stent aims to provide improved treatment for patients with symptomatic peripheral arterial disease in the above-the-knee femoropopliteal arteries. On October 13, 2011, the Food and Drug Administration's (FDA) Circulatory System Devices Panel reviewed the Zilver PTX premarket approval application. This summary aims to describe the discussions and recommendations made during the meeting. Based on the Panel's recommendations, it is anticipated that the device will be approved by the FDA. Copyright © 2012. Published by Elsevier Inc.

  18. Supera self-expanding stents for endovascular treatment of femoropopliteal disease: a review of the clinical evidence.

    PubMed

    Bishu, Kalkidan; Armstrong, Ehrin J

    2015-01-01

    Femoropopliteal lesions account for a significant proportion of endovascular interventions for peripheral artery disease in patients with disabling claudication or chronic limb ischemia. The femoropopliteal artery crosses two joint structures (hip and knee joints) and courses through the muscular adductor canal in the thigh, which places the artery at increased biomechanical stress. There is a critical need for stent platforms with a reduced risk of stent fracture while maintaining patency during long-term follow-up. The Supera peripheral stent system has a braided nickel-titanium alloy stent designed to withstand the unique stressors along the course of the femoropopliteal artery. This design may be associated with improved patency in association with reduced stent fracture rates on short- and medium-term follow-up. Further studies, including randomized controlled studies, comparing the Supera interwoven nickel-titanium alloy stent system with other stent platforms and angioplasty alone are needed.

  19. Endovascular stenting of mid-aortic syndrome due to Takayasu arteritis.

    PubMed

    Dogan, Ali; Sever, Kenan; Ozdemir, Emrah; Mansuroglu, Denyan; Kurtoglu, Nuri

    2017-09-13

    Introduction-patients: Takayasu arteritis may involve various parts of the aorta and its major branches. It leads to occlusive or aneurysmal disease of the vessel. It can be treated either with surgery or percutaneous intervention. We report a successful endovascular treatment of stenosis of the descending thoracic and abdominal aorta in a 19-year-old female. Methods-results-conclusions: Self-expandable nitinol stent was deployed and adequate opening of the aorta was obtained in this patient. Long-term durability of endovascular approach is a matter of debate. We also reviewed the sufficiency of endovascular treatment versus surgery.

  20. Early Stent Graft Perforation after Endovascular Repair for Pseudoaneurysm That Was Associated with Clavicle Nonunion

    PubMed Central

    Touma, Masanao; Ohno, Nobuhisa; Yoshikawa, Eiji; Yoshizawa, Kousuke; Fujiwara, Keiichi

    2015-01-01

    We report the case of a 62-year-old man who experienced a left axillary artery pseudoaneurysm that was secondary to nonunion of a 30-year-old left midshaft clavicle fracture. He initially underwent endovascular repair using a self-expanding nitinol stent graft, which was perforated at postoperative day 5. Therefore, we performed open repair with concomitant clavicle resection, and no complications were observed during an approximately 6-year follow-up. We recommend performing clavicle resection with vascular repair to prevent recurrence in similar cases. PMID:26421082

  1. Effect of a balloon-expandable intracranial stent vs medical therapy on risk of stroke in patients with symptomatic intracranial stenosis: the VISSIT randomized clinical trial.

    PubMed

    Zaidat, Osama O; Fitzsimmons, Brian-Fred; Woodward, Britton Keith; Wang, Zhigang; Killer-Oberpfalzer, Monika; Wakhloo, Ajay; Gupta, Rishi; Kirshner, Howard; Megerian, J Thomas; Lesko, James; Pitzer, Pamela; Ramos, Jandira; Castonguay, Alicia C; Barnwell, Stanley; Smith, Wade S; Gress, Daryl R

    Intracranial stenosis is one of the most common etiologies of stroke. To our knowledge, no randomized clinical trials have compared balloon-expandable stent treatment with medical therapy in symptomatic intracranial arterial stenosis. To evaluate the efficacy and safety of the balloon-expandable stent plus medical therapy vs medical therapy alone in patients with symptomatic intracranial stenosis (≥70%). VISSIT (the Vitesse Intracranial Stent Study for Ischemic Stroke Therapy) trial is an international, multicenter, 1:1 randomized, parallel group trial that enrolled patients from 27 sites (January 2009-June 2012) with last follow-up in May 2013. Patients (N = 112) were randomized to receive balloon-expandable stent plus medical therapy (stent group; n = 59) or medical therapy alone (medical group; n = 53). a composite of stroke in the same territory within 12 months of randomization or hard transient ischemic attack (TIA) in the same territory day 2 through month 12 postrandomization. A hard TIA was defined as a transient episode of neurological dysfunction caused by focal brain or retinal ischemia lasting at least 10 minutes but resolving within 24 hours. Primary safety measure: a composite of any stroke, death, or intracranial hemorrhage within 30 days of randomization and any hard TIA between days 2 and 30 of randomization. Disability was measured with the modified Rankin Scale and general health status with the EuroQol-5D, both through month 12. Enrollment was halted by the sponsor after negative results from another trial prompted an early analysis of outcomes, which suggested futility after 112 patients of a planned sample size of 250 were enrolled. The 30-day primary safety end point occurred in more patients in the stent group (14/58; 24.1% [95% CI, 13.9%-37.2%]) vs the medical group (5/53; 9.4% [95% CI, 3.1%-20.7%]) (P = .05). Intracranial hemorrhage within 30 days occurred in more patients in the stent group (5/58; 8.6% [95% CI, 2

  2. Self-expanding metal stents (SEMS) for preoperative biliary decompression in patients with resectable and borderline-resectable pancreatic cancer: outcomes in 241 patients.

    PubMed

    Siddiqui, Ali A; Mehendiratta, Vaibhav; Loren, David; Kowalski, Thomas; Fang, John; Hilden, Kristen; Adler, Douglas G

    2013-06-01

    Obstructive jaundice caused by distal biliary obstruction can present in up to 70 % of patients with localized cancer of the head of the pancreas. The aim of this study was to report our experience in using self-expanding metal stents (SEMS) for preoperative biliary decompression in patients with resectable and borderline resectable carcinoma of the pancreatic head. We performed a retrospective study evaluating patients from two tertiary referral centers. Two-hundred and forty-one patients with resectable and borderline resectable pancreatic carcinoma underwent ERCP with metal biliary stent placement between September 2006 and August 2011. We assessed the effectiveness of SEMS to adequately decompress the biliary tree, procedural success, patient survival, stent patency, and stent-related complications. Two-hundred and forty-one patients were evaluated [123 male, mean age (± SD) 67.4 ± 9.8 years; resectable 174, borderline resectable 67]. Patients with borderline-resectable cancer underwent neoadjuvant therapy and restaging before possible curative surgery. Successful placement of a metal biliary stent was achieved in all patients and improved jaundice. Patients were followed for mean duration of 6.3 months. The overall survival was 49 % at 27 months. Fourteen (5.8 %) patients experienced stent occlusion; the mean time to stent occlusion was 6.6 (range 1-20) months. Immediate complications included: post-ERCP pancreatitis (n = 14), stent migration (n = 3), and duodenal perforation (n = 3). Long-term complications included stent migration (n = 9) and hepatic abscess (n = 1). A total of 144/174 patients deemed to have resectable cancer at time of diagnosis underwent curative surgery. Due to disease progression or the discovery of metastasis after neoadjuvant therapy, only 22/67 patients with borderline-resectable cancer underwent curative surgery. SEMS should be considered for patients with obstructive jaundice and resectable or borderline resectable pancreatic

  3. Intra-aneurysmal hemodynamic alterations by a self-expandable intracranial stent and flow diversion stent: high intra-aneurysmal pressure remains regardless of flow velocity reduction.

    PubMed

    Shobayashi, Yasuhiro; Tateshima, Satoshi; Kakizaki, Ryuichi; Sudo, Ryo; Tanishita, Kazuo; Viñuela, Fernando

    2013-11-01

    Little is known about how much protection a flow diversion stent provides to a non-thrombosed aneurysm without the adjunctive use of coils. A three-dimensional anatomically realistic computation aneurysm model was created from the digital subtraction angiogram of a large internal carotid artery-ophthalmic artery aneurysm which could have been treated with either a neck bridging stent or a flow diversion stent. Three-dimensional computational models of the Neuroform EZ neck bridging stent and Pipeline embolization device were created based on measurements with a stereo-microscope. Each stent was placed in the computational aneurysm model and intra-aneurysmal flow structures were compared before and after placement of the stents. Computational fluid dynamics were performed by numerically solving the continuity and Navier-Stokes momentum equations for a steady blood flow based on the finite volume method. Blood was assumed as an incompressible Newtonian fluid. Vessel walls were assumed to be rigid, and no-slip boundary conditions were applied at the lumens. To estimate the change in the intra-aneurysmal pressures we assumed that, at the inlets, the intra-arterial pressure at peak systole was 120 mm Hg both before and after stent placement Without any stent, the blood flow entered into the aneurysm dome from the mid to proximal neck area and ascended along the distal wall of the aneurysm. The flow then changed its direction anteriorly and moved along the proximal wall of the aneurysm dome. In addition to the primary intra-aneurysmal circulation pattern, a counterclockwise vortex was observed in the aneurysm dome. The placement of a Neuroform EZ stent induced a mean reduction in flow velocity of 14% and a small change in the overall intra-aneurysmal flow pattern. The placement of a Pipeline device induced a mean reduction in flow velocity of 74% and a significant change in flow pattern. Despite the flow velocity changes, Neuroform EZ and Pipeline devices induced

  4. Safety and efficacy of palliative systemic chemotherapy combined with colorectal self-expandable metallic stents in advanced colorectal cancer: A multicenter study.

    PubMed

    Cézé, Nicolas; Charachon, Antoine; Locher, Christophe; Aparicio, Thomas; Mitry, Emmanuel; Barbieux, Jean-Pierre; Landi, Bruno; Dorval, Etienne; Moussata, Driffa; Lecomte, Thierry

    2016-04-01

    Self-expandable metallic stent (SEMS) placement is an accepted palliative therapy for management of acute malignant bowel obstruction in advanced colorectal cancer. Nevertheless, data are lacking on the effects of systemic chemotherapy combined with colorectal SEMS. The aim of this study was to investigate the safety and efficacy of palliative chemotherapy for advanced colorectal cancer combined with colorectal SEMS placement. This multicentre retrospective study included all consecutive advanced colorectal cancer patients who received first-line palliative chemotherapy combined with endoscopic stenting for colorectal cancer with obstruction. We analyzed the number of cycles and the type of combination used. The primary endpoint was overall survival. Secondary endpoints included progression-free survival, response rate, grade 3-4 toxicity and the outcomes of SEMS for malignant colorectal obstruction. A total of 38 patients were included. Among them, 25 patients received oxaliplatin and 5-fluorouracil combination chemotherapy. Objective response and stabilization occurred in 38 and 24% of patients, respectively. The median overall survival and progression-free survival from the start of chemotherapy were 18 and 5months, respectively. The objective response rate and overall disease control rate were 38 and 62%, respectively. Toxicity was generally acceptable. Major complications related to stenting included perforation (8%), stent migration (5%), and reobstruction secondary to tumor ingrowths (13%). Chemotherapy combined with colonic stenting as a first-line treatment seems to be a valid option in advanced colorectal cancer patients with malignant colorectal obstruction. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

  5. Experimental off-pump transventricular pulmonary valve replacement using a self-expandable valved stent: A new approach for pulmonary incompetence after repaired tetralogy of Fallot?

    PubMed

    Godart, François; Bouzguenda, Ivan; Juthier, Francis; Wautot, Fabrice; Prat, Alain; Rey, Christian; Corseaux, Delphine; Ung, Alexandre; Jude, Brigitte; Vincentelli, André

    2009-05-01

    Off-pump valve replacement using self-expandable stents is an emerging technique for pulmonary valve disease. However, significant limitations are the lack of easily available valve substitute to be inserted within the stent and, in the setting of repaired tetralogy of Fallot, the existence of huge pulmonary trunk. We report the first experimental results of a transventricular approach using a decellularized porcine xenograft mounted in a self-expandable stent. Pulmonary valve replacement was realized in 15 lambs by direct access of the infundibulum through a left thoracotomy, combined with pulmonary artery banding. Animals were followed by transthoracic echocardiography and, after control hemodynamic study, were electively killed either at day 7, month 1, or month 4 after implantation. Implantation succeeded in all lambs. Two animals died after implantation (1 pneumothorax and 1 endocarditis). Doppler echocardiographic follow-up did not show any significant transvalvular gradient and showed only mild pulmonary regurgitation. The hemodynamic control before termination revealed a systolic pulmonary valve gradient of 18.5 +/- 12.4 mm Hg at 1 week (n = 4), 13.5 +/- 10.6 mm Hg at 1 month (n = 4), and 4.3 +/- 4.9 mm Hg at 4 months (n = 5). Gross examination demonstrated the presence of connective tissue between the valved stent and pulmonary wall, which increased with time. Fifteen lambs underwent successful deployment of a self-expandable valved stent in the pulmonary position using a transventricular approach. This technique combined with pulmonary artery banding could be a therapeutic option for pulmonary insufficiency after repair of tetralogy of Fallot with a transannular patch.

  6. 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.

  7. Correction: Prospective pilot study of fully covered self-expandable metal stents for refractory benign pancreatic duct strictures: long-term outcomes

    PubMed Central

    Matsubara, Saburo; Sasahira, Naoki; Isayama, Hiroyuki; Takahara, Naminatsu; Mizuno, Suguru; Kogure, Hirofumi; Yamamoto, Natsuyo; Nakai, Yousuke; Tada, Minoru; Koike, Kazuhiko

    2016-01-01

    Background and study aims: Background and study aims: Temporary placement of a fully covered self-expandable metal stent (FCSEMS) has recently emerged as a treatment option for pancreatic duct strictures due to chronic pancreatitis refractory to conventional plastic stenting. However, there are no data about long-term outcomes with this therapeutic option. The aims of the current study were to estimate the feasibility, safety, efficacy, and long-term outcomes of temporary FCSEMS placement for refractory pancreatic duct strictures. Patients and methods: This was a prospective, single-center feasibility study. Ten patients with refractory pancreatic duct strictures due to chronic pancreatitis underwent FCSEMS placement for 3 months. We evaluated the rate of recurrent symptoms after stent removal during long-term follow-up, as well as adverse events (AEs). Results: Two patients required early (within 1 week) stent removal because of intolerable pain or pancreatitis. In the remaining 8 patients, the recurrence rate of any symptoms after FCSEMS removal was 63% during 35 months of follow up. The causes of recurrent symptoms were as follows: recurrence of stricture in 2; stent-induced stricture in 1; impaction of pancreatic stones in 1; and development of a pseudocyst in 1. When limited to stricture, the recurrence rate was 38%. Additional endoscopic treatments were required in 4 patients: a second FCSEMS placement in 1; plastic stent (PS) placement in 1; stone extraction in 1; and endoscopic ultrasound–guided pseudocyst drainage in 1. Asymptomatic stent migration occurred in 2 patients. Suppurative pancreatic ductitis due to food impaction in the FCSEMS occurred in 2 patients, and endoscopic pancreatic duct drainage was performed. Stent-induced ductal changes developed in 2 patients and PS treatment was required in 1 patient for pain relief. Conclusion: The FCSEMS appears to be a feasible and potentially effective option for the management of refractory pancreatic duct

  8. 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

  9. Tissue Responses to Endovascular Stent Grafts for Saccular Abdominal Aortic Aneurysms in a Canine Model

    PubMed Central

    Kim, Hyun Beom; Choi, Young Ho; So, Young Ho; Min, Seung-Kee; Kim, Hyo-Cheol; Kim, Young Il; Park, Jae Hyung

    2012-01-01

    We investigated tissue responses to endoskeleton stent grafts for saccular abdominal aortic aneurysms (AAAs) in canines. Saccular AAAs were made with Dacron patch in 8 dogs, and were excluded by endoskeleton stent grafts composed of nitinol stent and expanded polytetrafluoroethylene graft. Animals were sacrificed at 2 months (Group 1; n = 3) or 6 months (Group 2; n = 5) after the placement, respectively. The aortas embedding stent grafts were excised en bloc for gross inspection and sliced at 5 to 8 mm intervals for histopathologic evaluation. Stent grafts were patent in all except a dog showing a thrombotic occlusion in Group 2. In the 7 dogs with patent lumen, the graft overhanging the saccular aneurysm was covered by thick or thin thrombi with no endothelial layer, and the graft over the aortic wall was completely covered by neointima with an endothelial layer. Transgraft cell migration was less active at an aneurysm than at adjacent normal aorta. In conclusion, endoskeleton stent grafts over saccular aneurysms show no endothelial coverage and poor transgraft cell migration in a canine model. PMID:23091313