scholarly journals Biosafety of a novel covered self-expandable metal stent coated with poly(2-methoxyethyl acrylate) in vivo

PLoS ONE ◽  
2021 ◽  
Vol 16 (9) ◽  
pp. e0257828
Author(s):  
Tetsuya Ishizawa ◽  
Naohiko Makino ◽  
Yasuharu Kakizaki ◽  
Akiko Matsuda ◽  
Yoshihide Toyokawa ◽  
...  
Keyword(s):  
Bile Ducts ◽  
Histological Analysis ◽  
Inflammatory Marker ◽  
Metal Stents ◽  
Endoscopic Biliary Drainage ◽  
Metal Stent ◽  
Endoscopic Retrograde ◽  
Serological Examination

Covered self-expandable metal stents (CSEMS) are often used for palliative endoscopic biliary drainage; however, the unobstructed period is limited because of sludge occlusion. The present study aimed to evaluate the biosafety of a novel poly(2-methoxyethyl acrylate)-coated CSEMS (PMEA-CSEMS) for sludge resistance and examine its biosafety in vivo. Using endoscopic retrograde cholangiopancreatography, we placed the PMEA-CSEMS into six normal porcine bile ducts and conventional CSEMS into three normal porcine bile ducts. We performed serological examination and undecalcified histological analysis at 1, 3, and 6 months during follow-up. In the bile ducts with PMEA-CSEMS or conventional CSEMS, we observed no increase in liver enzyme or inflammatory marker levels in the serological investigations and mild fibrosis but no inflammatory response in the histopathological analyses. Thus, we demonstrated the biosafety of PMEA-CSEMS in vivo.

scholarly journals Safety and outcomes of endoscopic ultrasound-guided drainage for malignant biliary obstruction using cautery-enabled lumen-apposing metal stent

2020 ◽  
Vol 08 (11) ◽  
pp. E1633-E1638
Author(s):  
Jerry Yung-Lun Chin ◽  
Samir Seleq ◽  
Frank Weilert
Keyword(s):  
Clinical Success ◽  
Clinical Success Rate ◽  
Metal Stents ◽  
Metal Stent ◽  
Endoscopic Retrograde ◽  
Stent Patency ◽  
Stent Occlusion ◽  
Secondary Endpoints ◽  
Mean Time

Abstract Background and study aims There is increasing evidence to suggest that EUS-guided biliary drainage (EUS-BD) is a safe and effective treatment alternative for patients with malignant biliary obstructions (MBOs) after failed endoscopic retrograde cholangiopancreatography. Patients and methods We performed a retrospective analysis of data prospectively collected from patients with MBO who underwent choledochoduodenostomy (CDS) or gallbladder drainage (GBD) between August 2016 and June 2020 using the electrocautery-enabled lumen-apposing metal stents (ECE-LAMS). The primary endpoint was technical and clinical success. Secondary endpoints were adverse events (AEs) and reinterventions. Results A total of 60 patients were included in the study, with 56 CDS and 4 GBD. Median age was 76 years with 57 % male (34/60). The most common indication for EUS-BD was pancreatic cancer (78 %). Technical success was achieved in 100 % of cases, with a clinical success rate of 91.7 %. Mean total bilirubin pre-procedure was 202 umol/L (normal < 20 umol/L) and 63.8 umol/L post procedure (P < .001). Twenty-one patients had bilirubin recorded at 2 weeks post EUS-BD with 20 of 21 patients demonstrating > 50 % reduction in bilirubin (mean bilirubin reduction 75 %). AEs occurred in 12 of 60 patients (20 %), all of which were mild. The reintervention rate was 11.7 % (7/60). Stent occlusion occurred in 10 of 60 patients (16.7 %) with a mean time to stent occlusion of 46.2 days (3–133). Stent patency of 83.3 % was observed with a mean follow up of 7.9 months. Conclusion EUS-CDS and GBD using ECE-LAMS are effective EUS-based techniques for managing patients with MBO. AEs are usually mild and resolved by reintervention.

Patients with in-stent restenoses

2007 ◽  
Vol 46 (05) ◽  
pp. 185-191 ◽  
Author(s):  
T. Nusser ◽  
B. J. Krause ◽  
M. Kochs ◽  
T. Habig ◽  
F. M. Mottaghy ◽  
...  
Keyword(s):  
Primary Endpoint ◽  
Bare Metal Stents ◽  
Target Lesion ◽  
Bare Metal Stent ◽  
Metal Stents ◽  
Bare Metal ◽  
Metal Stent ◽  
Post Intervention ◽  
Angiographic Restenosis

SummaryAims: We compared the intracoronary β-brachytherapy using a liquid rhenium-188 filled balloon with the slow-release, polymer-based, paclitaxel-eluting Taxus-Express stent for treatment of in-stent restenoses. Patients, methods: During the same study period, patients with restenoses in bare-metal stents were either treated with Taxus- Express stents (n = 50) or β-brachytherapy after successful angioplasty (n = 51). For brachytherapy 30 Gy in 0.5 mm tissue depth were administered. The irradiated segment exceeded the traumatized segment 7.5 mm on both sides. Primary endpoint was the minimal lumen diameter (MLD) at the target lesion at six months follow-up. Angiographic follow-up was available in 78% (n = 79/101) and clinical follow-up in all patients. Results: Baseline parameters did not differ statistically. The Taxus-Express stent resulted in a significantly larger MLD and a significantly lower percent diameter stenosis post intervention compared to β-brachytherapy, which both maintained until angiographic follow-up (primary endpoint 2.44 ± 0.74 mm versus 1.73 ± 0.74 mm, p <0.0001). Therefore, Taxus- Express stents were associated with a lower angiographic restenosis rate compared with β-brachytherapy, both for the target lesion (6.1% versus 17.4%) and the total segment (9.1% versus 23.9%). Moreover, use of Taxus-stent was associated with a clinical benefit based on a significantly lower MACE rate compared with β-brachytherapy (p <0.05). Conclusions: Paclitaxel-eluting Taxus- Express stents resulted in superior clinical and angiographic outcomes compared to intracoronary β-brachytherapy with a liquid 188Re filled balloon for treatment of restenosis within a bare-metal stent.

scholarly journals Self-Expanding Metal Stenting for Palliation of Patients with Malignant Colonic Obstruction: Effectiveness and Efficacy on 255 Patients with 12-Month's Follow-up

2012 ◽  
Vol 2012 ◽  
pp. 1-6 ◽  
Author(s):  
Søren Meisner ◽  
Ferran González-Huix ◽  
Jo G. Vandervoort ◽  
Alessandro Repici ◽  
Dimitrios Xinopoulos ◽  
...  
Keyword(s):  
Stent Placement ◽  
Clinical Success ◽  
Colonic Obstruction ◽  
Metal Stents ◽  
Control Group ◽  
Metal Stent ◽  
Multicenter Studies ◽  
Malignant Colonic Obstruction ◽  
Procedural Success

Background. Self-expanding metal stents can alleviate malignant colonic obstruction in incurable patients and avoid palliative stoma surgery.Objective. Evaluate stent effectiveness and safety on palliation of patients with malignant colorectal strictures.Design. Two prospective, one Spanish and one global, multicenter studies.Settings. 39 centers (22 academic, 17 community hospitals) from 13 countries.Patients. A total of 257 patients were enrolled, and 255 patients were treated with a WallFlex uncovered enteral colonic stent. Follow-up was up to 12 months or until death or retreatment.Interventions(s). Self-expanding metal stent placement.Main Outcome Measures. Procedural success, clinical success, and safety.Results. Procedural success was 98.4% (251). Clinical success rates were 87.8% at 30 days, 89.7% at 3 months, 92.8% at 6 months, and 96% at 12 months. Overall perforation rate was 5.1%. Overall migration rate was 5.5%. Overall death rate during follow-up was 48.6% (124), with 67.7% of deaths related to the patient’s colorectal cancer, unrelated in 32.3%. Only 2 deaths were related to the stent or procedure.Limitations. No control group.Conclusions. The primary palliative option for patients with malignant colonic obstruction should be self-expanding metal stent placement due to high rates of technical success and efficacy in symptom palliation and few complications.

scholarly journals PRECLINICAL EVALUATION OF THE VASCULAR EFFECTS OF REJUVENATE® COBALT CHROMIUM CORONARY STENT SYSTEM IMPLANTED IN THE PORCINE CORONARY IN STENT RESTENOSIS MODEL

2021 ◽  
Vol 54 (2) ◽  
pp. 132-138
Author(s):  
Murtaza Najabat Ali ◽  
Mariam Mir ◽  
Piotr Buszman
Keyword(s):  
Vascular Tissue ◽  
Bare Metal Stents ◽  
Bare Metal Stent ◽  
Metal Stents ◽  
Bare Metal ◽  
Cobalt Chromium ◽  
Metal Stent ◽  
Stent Patency ◽  
The Mean

Objectives: The main objective of the study was to evaluate the implantation, safety, and vascular tissue effects of REJUVENATE® Cobalt Chromium Bare Metal Stent in the Porcine Coronary Restenosis model at short, mid and long-term follow up. Methodology: A total of 18 REJUVENATE® bare metal stents (CoCr, 95 µm strut thickness) were implanted into the coronary arteries (RCA, LCX and LAD) of the six pigs. Throughout the study period, stent patency, vascular response, percent stenosis, late lumen loss and performance of stent were evaluated by angiography, optical coherence tomography (OCT), and Histopathology (includes both Histopathology and histomorphometry) at 30, 90, and 180 days and compared with the results of control Bare Metal Stent Coflexus®. The mean, variance and standard deviation was analyzed using SPSS software. Results: OCT and QCA analysis demonstrated two cases of binary restenosis at 30 days follow-up and two at 90 days follow-up (33%). The mean area stenosed for Rejuvenate® was 34% as compared to 24% of Coflexus® and at 180 days follow up, it decreased to 21%. The histopathology analysis demonstrated favorable safety with acceptable levels of neointimal formation, with decreased levels of inflammation and complete endothelialization in 180 days. Conclusion: This study proved the potential safety of REJUVENATE® in porcine model and supports that this stent can move forward for the human trials.

scholarly journals Forgotten metal stent (3 years) presenting with a high burden of intra- and extra-hepatic ducts stones and cholangitis

2019 ◽  
Vol 2019 (10) ◽  
Author(s):  
Chiapo Lesetedi ◽  
Mpapho Joseph Motsumi
Keyword(s):  
Bile Duct ◽  
Open Cholecystectomy ◽  
Metal Stent ◽  
Endoscopic Retrograde ◽  
Plastic Stent ◽  
High Burden ◽  
Surgical History ◽  
History Of ◽  
Lost To Follow Up

Abstract Forgotten stents may lead to serious complications. We present a case report of a forgotten common bile duct (CBD) fully covered metal stent presenting with recurrent cholangitis. A 79-years-old female patient presented with a history of recurrent cholangitis. Past surgical history was notable for open cholecystectomy for symptomatic cholelithiasis in 2016. Subsequently, she was found to have retained CBD stones in the same year. She had endoscopic retrograde cholangiopancreatography (ERCP), during which a complete clearance of the stone was not achieved and she was stented with a completely covered metal stent. She was lost to follow-up until 2019. A differential diagnosis of cholangitis secondary to a blocked stent was made. At ERCP, she had intra- and extra-hepatic stones, which could not be removed. A plastic stent was deployed. She later had an open bile duct exploration with Roux-en-Y hepaticojejunostomy. Forgotten stents can lead to serious complications. An electronic stent follow-up registry is recommended.

scholarly journals Triple Covered Metal Stent Deployment Using Side-by-Side Technique for Hemobilia due to Hepatocellular Carcinoma (with Video)

2019 ◽  
Vol 38 (4) ◽  
pp. 348-351
Author(s):  
Takeshi Ogura ◽  
Tadahiro Yamada ◽  
Masanori Yamada ◽  
Saori Ueno ◽  
Kazuhide Higuchi
Keyword(s):  
Hepatocellular Carcinoma ◽  
Surgical Treatment ◽  
Bile Duct ◽  
Bile Ducts ◽  
Metal Stents ◽  
High Grade ◽  
Poor General Condition ◽  
Metal Stent ◽  
Stent Deployment ◽  
Bile Duct Invasion

A hepatocellular carcinoma (HCC) rarely expands into the biliary tract. In this situation, because of its hypervascular nature, cholangitis or hemobilia may sometimes occur. Surgery is one of the options in this situation. However, patients with HCC and bile duct invasion are sometimes in a poor general condition, as in the case presented in this report. For such patients, surgical treatment may need to be invasive. Thus, here we report technical tips for triple covered metal stent deployment using side-by-side technique for hemobilia due to HCC. After guidewire deployments at the left, anterior, and posterior bile ducts, 6-mm covered self-expandable metal stents were placed at each bile duct. This may be useful for high-grade hepatic hilar obstruction due to HCC because drainage and hemostasis effects are obtained.

scholarly journals Lumen-apposing metal stent through the meshes of duodenal metal stents for palliation of malignant jaundice

2021 ◽  
Vol 09 (03) ◽  
pp. E324-E330
Author(s):  
Benedetto Mangiavillano ◽  
Rastislav Kunda ◽  
Carlos Robles-Medranda ◽  
Roberto Oleas ◽  
Andrea Anderloni ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Standard Procedure ◽  
Pancreatic Head ◽  
Serum Levels ◽  
Metal Stents ◽  
Technical Failure ◽  
Metal Stent ◽  
Malignant Jaundice ◽  
Duodenal Stent

Abstract Background and study aims Endoscopic retrograde cholangiopancreatography (ERCP) is the gold standard procedure for malignant jaundice palliation; however, it can be challenging when a duodenal self-expandable metal stent (SEMS) is already in place. Patients and methods The primary aim of our study was to evaluate the technical feasibility of the placement of a lumen apposing metal stent (LAMS) through the mesh (TTM) of duodenal stents. The secondary aims were to evaluate clinical outcomes and adverse events (AEs) related to the procedures. Results Data from 23 patients (11 F and 12 M; mean age: 69.5 ± 11 years old) were collected. In 17 patients (73.9 %) TTM LAMS placement was performed as first intention, while in six patients (26.1 %) it was performed after a failed ERCP. Thirteen patients (56.5 %) underwent the procedure due to advanced pancreatic head neoplasia. One technical failure was experienced (4.3 %). The TTM LAMS placement led to a significant decrease in the serum levels of bilirubin, ALP, GGT, WBC and CRP. No cases of duodenal SEMS occlusion occurred and no other AEs were observed during the follow-up. Conclusions Concomitant malignant duodenal and biliary obstruction is a challenging condition. Palliation of jaundice using TTM LAMS in patients already treated with duodenal stent is associated to promising technical and clinical outcomes.

scholarly journals What is the Impact of the Proportion of Solid Necrotic Content on the Number of Necrosectomies during EUS-Guided Drainage using Lumen-Apposing Metallic Stents of Pancreatic Walled-off Necrosis ?

2020 ◽  
Vol 29 (4) ◽  
pp. 623-628
Author(s):  
Andrada Seicean ◽  
Cristina Pojoga ◽  
Ofelia Mostean ◽  
Sorana Bolboaca ◽  
Madalina Ilie ◽  
...  
Keyword(s):  
Pancreatic Necrosis ◽  
Clinical Success ◽  
Metal Stents ◽  
Metal Stent ◽  
Endoscopic Necrosectomy ◽  
Medical Centers ◽  
One Step ◽  
Walled Off Necrosis ◽  
The Impact

Background and Aims: The fully-covered, lumen apposing metal stents are designed for one step placement, facilitating the direct endoscopic necrosectomy into the walled-off pancreatic necrosis. However, the prediction of the number of necrosectomy sessions in these patients is not known. This study evaluated the association between the proportion of solid necrotic material inside walled-off necrosis, as assessed during the endosonography placement of a lumen apposing metal stent, and the number of necrosectomies subsequently required. Methods: Patients from three tertiary medical centers with symptomatic walled off pancreatic necrosis (pain, infection, gastric/biliary obstruction) at more than 4 weeks after onset of acute pancreatitis were retrospectively analysed. Proportion of solid necrotic debris was estimated during endosonography procedure of lumen apposing metal stents placement. Necrosectomy was performed when obstruction or inflammation occurred subsequently. Lumen apposing metal stents were removed after clearance of necrotic content. Results: In 46 patients with successful lumen apposing metal stents placement, necrosectomy was performed in 39 patients (72.78%). Performance of 3 or more necrosectomies was significantly associated with more than 50% pancreatic necrosis (p=0.032), but not with walled-off pancreatic necrosis size or location. Necrotic infection during lumen apposing metal stents stenting was associated with hypoalbuminemia, but not with necrosectomy requirement. Clinical success after a median follow-up of 13.37 months was 87%. Conclusions: Walled-off pancreatic necrosis with more than 50% solid necrotic content were associated with more necrosectomy procedures, requiering longer endoscopy time, intravenous sedations, and higher costs.

Combining the Passeo-18 Lux Drug-Coated Balloon and the Pulsar-18 Bare Metal Stent: 12- and 24-Month Outcomes of the BIOLUX 4EVER Investigator-Initiated Trial

2020 ◽  
Vol 27 (6) ◽  
pp. 936-945
Author(s):  
Koen Deloose ◽  
Marc Bosiers ◽  
Patrick Peeters ◽  
Jürgen Verbist ◽  
Lieven Maene ◽  
...  
Keyword(s):  
De Novo ◽  
Ankle Brachial Index ◽  
Bare Metal Stents ◽  
Bare Metal Stent ◽  
Primary Patency ◽  
Metal Stents ◽  
Bare Metal ◽  
Metal Stent ◽  
Drug Coated Balloon

Purpose: To report the outcomes after treating stenotic or occluded femoropopliteal lesions with a drug-coated balloon (DCB) followed by the implantation of a thin-strut self-expanding bare metal stent in the BIOLUX 4EVER trial ( ClinicalTrials.gov identifier NCT02211664). Materials and Methods: The prospective, multicenter, physician-initiated BIOLUX 4-EVER trial was conducted at 5 centers in Belgium and enrolled 120 patients (mean age 70.9±10.5 years; 79 men) with symptomatic stenotic or occluded de novo femoropopliteal lesions. A fifth of the patients had diabetes mellitus and nearly half had previous peripheral artery interventions. The lesions were a mean 83.3±49.5 mm long with a mean reference vessel diameter of 5.26±0.59 mm. Lesions were treated with a Passeo-18 Lux DCB followed by the implantation of a Pulsar-18 bare metal stent. Follow-up visits were conducted at 1, 6, 12, and 24 months postprocedure; the main outcome was primary patency at 12 months. Results: Technical success was obtained in all patients. Primary patency was observed in 89.9% of patients (95% CI 84.0% to 95.8%) at 12 months and in 83.5% at 24 months (95% CI 89.9% to 97.3%), and freedom from target lesion revascularization was 93.6% (95% CI 89.9% to 97.3%) and 86.1% (95% CI 79.9% to 92.3%), respectively. Ten patients died throughout the course of the trial (90.7% survival at 24 months), all of noncardiovascular causes. The ankle-brachial index improved from 0.68±0.09 at baseline to 0.93±0.11 and 0.93±0.12 at 12- and 24-month follow-up visits (p<0.001). An improvement of at least 1 Rutherford category was observed in 91 of 94 patients (96.8%) at 12 months and 78 of 83 patients (93.4%) at 24 months (p<0.001). Conclusion: The combination of a Passeo-18 Lux DCB followed by a Pulsar-18 stent implantation produced safe and effective outcomes in the treatment of femoropopliteal lesions at up to 24 months. Adding paclitaxel to the bare nitinol stent platform by predilating with a Passeo-18 Lux DCB seems to increase efficacy at 1 and 2 years compared with the use of bare metal stents only, which were investigated in the precursor 4-EVER study.

scholarly journals Coronary stent CD31-mimetic coating favours endothelialization and reduces local inflammation and neointimal development in vivo

2021 ◽  
Author(s):  
Sergio Diaz-Rodriguez ◽  
Charlotte Rasser ◽  
Jules Mesnier ◽  
Pascale Chevallier ◽  
Romain Gallet ◽  
...  
Keyword(s):  
Bare Metal Stents ◽  
Dip Coating ◽  
Metal Stents ◽  
Leukocyte Activation ◽  
Cobalt Chromium ◽  
Metal Stent ◽  
Human Coronary Artery ◽  
Post Implantation

Abstract Aims The rapid endothelialization of bare metal stents (BMS) is counterbalanced by inflammation-induced neointimal growth. Drug-eluting stents (DES) prevent leukocyte activation but impair endothelialization, delaying effective device integration into arterial walls. Previously, we have shown that engaging the vascular CD31 co-receptor is crucial for endothelial and leukocyte homeostasis and arterial healing. Furthermore, we have shown that a soluble synthetic peptide (known as P8RI) acts like a CD31 agonist. The aim of this study was to evaluate the effect of CD31-mimetic metal stent coating on the in vitro adherence of endothelial cells (ECs) and blood elements and the in vivo strut coverage and neointimal growth. Methods and results We produced Cobalt Chromium discs and stents coated with a CD31-mimetic peptide through two procedures, plasma amination or dip-coating, both yielding comparable results. We found that CD31-mimetic discs significantly reduced the extent of primary human coronary artery EC and blood platelet/leukocyte activation in vitro. In vivo, CD31-mimetic stent properties were compared with those of DES and BMS by coronarography and microscopy at 7 and 28 days post-implantation in pig coronary arteries (n = 9 stents/group/timepoint). Seven days post-implantation, only CD31-mimetic struts were fully endothelialized with no activated platelets/leukocytes. At day 28, neointima development over CD31-mimetic stents was significantly reduced compared to BMS, appearing as a normal arterial media with the absence of thrombosis contrary to DES. Conclusion CD31-mimetic coating favours vascular homeostasis and arterial wall healing, preventing in-stent stenosis and thrombosis. Hence, such coatings seem to improve the metal stent biocompatibility.

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