Search

Background. There is a need for a more tolerable preoperative biliary drainage (PBD) method for perihilar cholangiocarcinoma (PHCC). In recent years, inside stents (ISs) have attracted attention as a less suffering PBD method. Few studies have compared IS with a fully covered self-expandable metallic stent (FCSEMS) as PBD for resectable PHCC. The aim of this study is to compare them. Methods. This study involved 86 consecutive patients (IS: 51; FCSEMS: 35). The recurrent biliary obstruction (RBO) rate until undergoing surgery or being diagnosed as unresectable, time to RBO, factors related to RBO, incidence of adverse events related to endoscopic retrograde cholangiography, and postoperative complications associated with each stent were evaluated retrospectively. Results. There was no significant difference between the two groups in the incidence of adverse events after stent insertion. After propensity score matching, the mean (SD) time to RBO was 37.9 (30.2) days in the IS group and 45.1 (35.1) days in the FCSEMS group, with no significant difference ( P = 0.912 , log-rank test). A total of 7/51 patients in the IS group and 3/35 patients in the FCSEMS group developed RBO. The only risk factor for RBO was bile duct obstruction of the future excisional liver lobe(s) due to stenting (HR 29.8, P = 0.008 ) in the FCSEMS group, but risk factors could not be indicated in the IS group. There was no significant difference in the incidence of bile leakage or liver failure. In contrast, pancreatic fistula was significantly more common in the FCSEMS group (13/23 patients) than in the IS group (3/28 patients) ( P < 0.001 ), especially in patients who did not undergo pancreatectomy ( P = 0.001 ). Conclusions. As PBD, both IS and FCSEMS achieved low RBO rates. Compared with FCSEMS, IS shows no difference in RBO rate, is associated with fewer postoperative complications, and is considered an appropriate means of PBD for resectable PHCC. This trail is registered with UMIN000025631.

Self-expandable metal stent (SEMS) placement is routinely performed in a variety of benign and malignant GI diseases. One of the most frequent adverse events after esophageal SEMS placement is stent migration. We evaluated a novel over-the-scope clip device (stentfix OTSC; Ovesco Endoscopy, Tuebingen, Germany) designed and approved for SEMS fixation.This single-center retrospective observational cohort study was performed to analyze stent migration rates before and after availability of the stentfix OTSC device. A cohort of patients who consecutively underwent SEMS fixation with the stentfix OTSC system (SF cohort) was compared with an historical cohort of patients who did not receive stentfix OTSC fixation or any other stent fixation method (NF cohort) before the stentfix OTSC system became available. Outcome variables including technical success, adverse events and clinical success were analyzed.Seventy-seven patients (SF cohort, 26; NF cohort, 51) underwent esophageal SEMS implantation for malignant (69%) and benign (31%) conditions. The technical success rate of stent fixation was 100%, and no procedure-related adverse events were observed. The stent migration rate was significantly lower in the SF cohort compared with the NF cohort (8.3% vs 35.4%, P .001), indicating a relative risk reduction of 76.5% associated with stentfix OTSC application. Stent implantation across the gastroesophageal junction was identified as a predictor of stent migration.In patients with benign or malignant gastroesophageal diseases, there was a significantly lower stent migration rate in patients managed with the stentfix OTSC system compared with those without stent fixation. The application was technically successful in all cases, and no adverse events related to clip application or removal were observed.

Background Self-expandable metallic stent (SEMS), an alternative to diverting stoma (DS), has been used as a “bridge to surgery” (BTS) to decompress acute obstruction of colorectal cancer (CRC) for decades. However, whether SEMS is a safe technique for obstruction of CRC without compromising the long-term survival of patients remains unidentified compared to those of DS. The aim of the present study was to elucidate the safety and survival outcomes of SEMS and DS. Methods Embase, PubMed, and Medline were searched for qualified studies published until October, 2020, in which SEMS or DS was performed as a BTS without resection at the same stage. The last search was on December 5th, 2020. The Newcastle–Ottawa scale (NOS) was used to assess the quality of included studies. The major complication rate, mortality, 3-year overall survival (OS), and permanent stoma rate were estimated as outcomes. Results The present study was registered on INPLASY (No. 2020100079). Seven eligible studies were included, involving 646 and 712 patients who underwent SEMS and DS treatments, respectively. The Clavien-Dindo I/II grade complication rate was significantly lower in the SEMS group than in the DS group (8.68 vs. 16.85%; RR, 0.59; 95% confidence interval (CI) 0.41–0.84; P = 0.004). The Clavien-Dindo III/IV grade complication rate was comparable in two groups (7.69 vs. 8.79%; RR, 0.82; 95% CI 0.54–1.27; P = 0.37). There were no statistical differences in the short-term mortality (5.16 vs. 4.53%; RR, 1.25; 95% CI 0.75–2.08; P = 0.39), 3-year OS (71.91 vs. 76.60%; RR, 0.93; 95% CI 0.86–1.01; P = 0.10), and permanent stoma rate (22.08 vs. 27.54%; RR, 0.84; 95% CI 0.67–1.06; P = 0.14) between the two groups. Conclusions To some extent, SEMS is a safe BTS technique for acute obstructive CRC, without significant adverse effect on the survival of patients. Given the advantage of minimal invasion, SEMS may be a better alternative to DS for obstructive CRC. However, the conclusions remain to be discussed because of lacking high-quality randomized controlled trails.

Endoscopic biliary drainage using a self-expandable metallic stent (SEMS) has been widely performed to treat distal malignant biliary obstruction (DMBO). However, the optimal position of the stent remains unclear.To determine the ideal position for SEMS placement.In total, 135 DMBO patients underwent SEMS (uncovered or covered) placement over a ten-year period. A total of 127 patients with biliary obstruction between the junction of the cystic duct and Vater's papilla were enrolled. An SEMS was placed through the upper common bile duct 2 cm from the biliary hilar duct in 83 patients (Hilar group) or near the top of the biliary obstruction in 44 patients (Lower group). Technical and functional success, adverse events, and risk factors for SEMS dysfunction were evaluated.The stent patency period was significantly longer in the Hilar group than in the Lower group (A longer patency period was achieved by positioning the SEMS near the biliary hilar duct.

The role of a covered vs. an uncovered self-expandable metal stent (SEMS) for malignant distal biliary obstruction (MDBO) is not clear. This meta-analysis compared the efficacy of covered vs. uncovered SEMS for patients with MDBO after endoscopic insertion.A systematic meta-analysis of all relevant articles listed in PubMed, the Cochrane Library, and Google Scholar databases was performed. Fixed effects or random effects models were used to investigate pooled effects with 95% confidence intervals (CIs).The meta-analysis included 2358 patients from 12 eligible studies. Time to recurrent biliary obstruction (RBO) was significantly longer for covered SEMS (mean difference, 45.51 days; 95% CI 11.79-79.24). Although there was no significant difference in the RBO rate, subgroup analysis in pancreatic cancer occupying more than 90% (PC) revealed that the RBO rates were significantly lower for covered SEMS (odds ratio [OR] 0.43, 95% CI 0.25-0.74). Stent migration, sludge formation, and overgrowth were significantly more common with a covered SEMS (OR 7.92, 95% CI 4.01-15.64; OR 3.25, 95% CI 1.89-5.59; OR 2.03, 95% CI 1.20-3.43, respectively). The rate of ingrowth was significantly lower for covered SEMS. There was no significant difference in total procedure-related adverse events between the two types of SEMS.A covered SEMS is superior to an uncovered SEMS with respect to prevention of RBO in patients with MDBO, particularly those caused by PC.

Benign biliary strictures (BBS) are usually treated with endoscopic retrograde cholangiopancreatography (ERCP) with the placement of multiple plastic stents (MPS) or a covered self-expandable metal stent (CSEMS). In this meta-analysis, we compared the efficacy and safety of MPS and CSEMS in the management of BBS. We reviewed several databases from inception to 28 April 2021 to identify RCTs that compared MPS with CSEMS in the management of BBS. Our outcomes of interest were stricture resolution, stricture recurrence, adverse events, stent migration and mean number of ERCPs to achieve stricture resolution. Data were analyzed using a random-effects model. We included eight RCTs with 524 patients. We found no significant difference in the rate of stricture resolution (risk ratio, 1.02; 95% CI, 0.96-1.10), stricture recurrence (risk ratio, 1.68; 95% CI, 0.72-3.88) or adverse events (risk ratio, 1.17; 95% CI, 0.73-1.87) between groups. Mean number of ERCPs was significantly lower in the CSEMS group (SMD, -1.99; 95% CI, -3.35 to -0.64). The rate of stent migration was significantly higher in the CSEMS group. CSEMS are comparable in efficacy and safety to MPS in the management of BBS but require fewer ERCPs to achieve stricture resolution.

Treatment of malignant biliary strictures with endoscopic retrograde cholangiopancreatography (ERCP) guided stent placement is highly effective. Our objective was to compare the efficacy and adverse outcomes between plastic stents (PS) and self-expandable metallic stents (SEMS).A cohort study was performed of all consecutive patients who underwent ERCP with stent placement for the management of malignant biliary stricture. Comparisons on clinical success, patency duration, stent dysfunction, unplanned reintervention and adverse outcomes were performed. Univariate and multivariable analyses were performed to identify factors associated with clinical success, need for reintervention, and stent dysfunction.From 2012 to 2019, 1139 patients underwent ERCP with PS placement while 1008 patients received SEMS for the management of malignant biliary stricture. In distal strictures, SEMS reported a significantly higher rate of clinical success compared with PS (94.1% vs 87.4%, P0.001) and a lower rate of unplanned reintervention (17.1% vs 27.4%, P0.001). In hilar strictures, the rates of clinical success and unplanned intervention were comparable. The patency duration and time to unplanned reintervention were significantly longer with SEMS than PS, irrespective of stricture location. In distal stricture, PS was associated with a significantly higher rate of cholangitis than SEMS (6.9% vs 2.4%; P.001) but a lower rate of pancreatitis (3.6% vs 6%; P = 0.021).Given superior efficacy, durability and lower rates of cholangitis, SEMS should be offered as the first line endoscopic treatment option for malignant distal biliary stricture. For malignant hilar stricture, SEMS is an attractive alternative to PS in some cases by offering a comparable efficacy with a superior durability.

Acute gastrointestinal obstruction due to colorectal cancer occurs in 7-30% of cases and is an abdominal emergency that requires urgent decompression. The safety and oncological effect of self-expandable metal stents (SEMS) in these patients remains controversial. This study aimed to evaluate its impact on these variables and compare it with that of emergency surgery (ES).Descriptive, retrospective and single-centre study, performed between 2008 and 2015, with follow-up until 2017. One hundred eleven patients with diagnosis of left malignant colonic obstruction were included and divided according to the treatment received: stent as bridge to surgery (SBTS group: 39), palliative stent (PS group: 30) and emergency surgery with curative (ECS group: 34) or palliative intent (EPS group: 8). Treatment was decided by the attending surgeon in charge.Technical and clinical general success rates for colorectal SEMS were 95.7% and 91.3%, respectively, with an associated morbimortality of 23.2%, which was higher in the PS group (p = 0.002). The SBTS group presented a higher laparoscopic approach and primary anastomosis (p 0.001), as well as a lower colostomy rate than the ECS group (12.8% vs. 40%; p = 0.023). Postoperative morbidity and mortality were significantly lower in the SBTS group compared to the ECS group (41% vs. 67.6%; p = 0.025). Overall survival (OS) and disease-free survival (DFS) were similar between the analysed groups.Colonic stent placement is a safe and effective therapeutic alternative to emergency surgery in the management of left-sided malignant colonic obstruction in both curative and palliative fields. It presents a lower postoperative morbimortality and a similar oncological prognosis.

Introduction: This multi-institutional retrospective study aimed to evaluate the efficacy of preoperative self-expandable metallic stent (SEMS) placement for patients with left-sided obstructive colorectal cancer (OCRC). Methods: Overall, 520 consecutive patients who received treatment for OCRC were enrolled. Of these, the data of 253 patients who underwent primary tumour resection for left-sided OCRC were reviewed. The short- and long-term outcomes were compared between the SEMS group and other three groups: transanal decompression tube (TaDT), decompressing stoma (DS), and emergency resection (ER). Results: The SEMS group had a higher frequency of laparoscopic surgery (p < 0.001), lesser frequency of postoperative stoma (p < 0.001), and more dissected lymph nodes (p < 0.001) than the other groups. Moreover, the SEMS group had shorter postoperative hospital stays than the TaDT, DS, and ER groups (p = 0.005, p = 0.037, and p < 0.001, respectively). The Kaplan-Meier survival curves of recurrence-free survival and overall survival did not differ significantly between the SEMS group and the other three groups in patients with stage II and III diseases. Discussion/Conclusion: Elective surgery after SEMS placement may improve short-term outcomes compared to other treatment strategies, with similar long-term outcomes.

The gastrointestinal tract is not a common site for metastasis from lung cancer, and colonic metastases are especially rare. Although surgical intervention can improve colonic obstruction, perioperative mortality is high in patients with advanced malignancy, and these patients experience a significant deterioration in quality of life postoperatively. This report describes an uncommon case of colonic metastasis from non-small cell lung cancer (NSCLC), in which colonic obstruction was improved with a self-expanding metallic stent. A 62-year-old man was admitted to our hospital for progressively worsening abdominal pain. He had been treated with immunotherapy and chemotherapy after being diagnosed with NSCLC (T4N2M1) 1.5 years earlier. Enhanced computed tomography showed intestinal obstruction and a mass in the colon at the hepatic flexure. Histopathological analysis of a biopsy specimen confirmed NSCLC metastasis. Considering his general condition, endoscopic stenting was chosen as an urgent decompression procedure. He was discharged 45 days after stenting and was able to resume immunotherapy. Emergency stenting could be offered at experienced centers when operative intervention is not part of the treatment plan, as it is safe and improves the efficiency of care along with the quality of life.

Expanding indications for neoadjuvant chemotherapy (NAC) for resectable pancreatic cancer prolong the period from diagnosis to surgery. In resectable pancreatic cancer with malignant biliary obstruction (MBO), the biliary drainage method without any biliary events is ideally required to safely perform NAC as planned. Plastic stents (PS) have been traditionally used for preoperative biliary drainage; however, recently, covered self-expandable metallic stents (CSEMS) have emerged as a tool for preoperative biliary drainage.To compare CSEMS with PS for preoperative biliary drainage in the management of resectable pancreatic cancer with MBO.In this multicenter retrospective cohort study, we compared CSEMS with PS for preoperative biliary drainage in patients with pancreatic cancer at three tertiary care centers between 2008 and 2019.Of the 120 enrolled patients, 45 underwent CSEMS and 75 underwent PS. No significant difference was observed in the basic characteristics between the groups. The rate of recurrent biliary obstruction (RBO) was significantly lower and the time to RBO was significantly longer in the CSEMS group. In multivariate analysis, CSEMS was an independent factor for a longer RBO. However, pancreatitis and cholecystitis were more common in the CSEMS group. The surgery-related adverse events were not significantly different between the two groups, except for longer surgery time and time to discharge in the CSEMS group.CSEMS for preoperative endoscopic biliary drainage in patients with pancreatic cancer reduced RBO, although the risk for pancreatitis or cholecystitis could be increased.

BACKGROUND AND AIM Durable biliary drainage is essential in patients with pancreatic cancer in the era of effective neoadjuvant chemotherapy (NACT). Plastic stent (PS) tends to occlude easily, and current metal stents are designed for nonresectable cancer. We evaluated the efficacy of a modified non-flared fully covered self-expandable metal stent (M-FCSEMS) during the perioperative period in patients with resectable or borderline resectable pancreatic cancer. METHODS Consecutive patients with resectable or borderline resectable pancreatic ductal adenocarcinoma had a 12-mm M-FCSEMS (M-FCSEMS group) or 7-Fr PS (PS group) placed for biliary decompression before NACT or curative-intent surgery. The primary outcome was the re-intervention rate, and secondary outcomes were technical success, stent patency, and adverse events (AEs). RESULTS Endoscopic stent placement was technically successful in all 60 patients. Twenty-three patients underwent surgery and 37 NACT before surgery. Re-intervention was performed in 10.0% (3/30) of patients in the M-FCSEMS group and 36.7% (11/30) of patients in the PS group (P = 0.030). The stent patency at 180 days was 89.8% (95% confidence interval, 77.3-100.0%) in the M-FCSEMS group and 30.2% (95% confidence interval, 11.4-80.0%) in the PS group (P

Objective This study aims to evaluate the effectiveness and safety of hepatic arterial infusion chemotherapy (HAIC) following the simultaneous placement of self-expandable metallic stent (SEMS) and iodine-125 (125I) seed strands for the management of advanced cholangiocarcinoma (CCA) patients presenting with malignant obstructive jaundice (MOJ). Methods Data from 74 patients with MOJ caused by advanced CCA treated with stent placement with 125I seed strands with or without HAIC between November 2015 and October 2020 were analysed retrospectively. Eighteen patients received 5 sessions of HAIC after SEMS placement with 125I seed strands (HAIC group), and 56 patients only underwent SEMS placement with 125I seed strands and served as controls (control group). HAIC consisted of infusions of gemcitabine (600-1000 mg/m2 given over 30 min) followed by oxaliplatin (60-100 mg/m2 given over 2 h), with an interval of 4 weeks. Propensity score matching (PSM) analysis was used to adjust for differences in the baseline characteristics of the groups (including age, total bilirubin, and serum alanine aminotransferase level). Overall survival (OS), stent patency, and adverse events were compared between the two groups. Results OS and stent patency were significantly better in patients in the HAIC group than in those in the control group (median survival time: before PSM, 362 vs. 185 days, p = 0.005; after PSM, 357 vs. 183 days, p = 0.012; median duration of stent patency: before PSM, 294 vs. 156 days, p = 0.001; after PSM, 287 vs. 183 days, p = 0.039). All adverse reactions were controllable by temporary symptomatic treatment. Serious complications and treatment-related deaths were not observed. Conclusion Our preliminary study showed that HAIC following SEMS placement with 125I seed strands is effective and safe for the management of advanced CCA patients presenting with MOJ and could improve stent patency and patient survival.

Fully covered self-expandable metal stents (FCSEMS) represent the latest advancement of metal biliary stents used to endoscopically treat a variety of obstructive biliary pathology. A large stent diameter and synthetic covering over the tubular mesh prolong stent patency and reduce risk for tissue hyperplasia and tumor ingrowth. Additionally, FCSEMS can be easily removed. All these features address issues faced by plastic and uncovered metal stents. The purpose of this paper is to comprehensively review the application of FCSEMS in benign and malignant biliary strictures, biliary leak, and post-sphincterotomy bleeding.

Banded Roux-en-Y gastric bypass (RYGB) was a common bariatric procedure in the 2000s, and the ring slippage is one of its late adverse events. Both plastic and metallic stents have been reported as adjunct methods to induce erosion and facilitate endoscopic removal of the ring. To compare the safety and effectiveness of self-expanding metallic stents (SEMS) and plastic stents (SEPS) to treat ring slippage. We conducted a retrospective longitudinal study analyzing consecutive patients with ring dysfunction treated with stents plus endoscopic removal. Ninety patients were enrolled (36 SEMS vs. 54 SEPS). The mean age was 48.56 ± 13.07 and 45.6 ± 12.1 in the SEMS and SEPS groups, respectively. All patients had band slippage, but 24 from SEMS group and 23 from SEPS group had further complications. There were more complications in metallic stent concerning mean absolute number of therapy-related adverse events (1.33 ± 0.48 vs. 1.72 ± 0.5, p > 0.05) and time until erosion (14.9 ± 1.6 vs. 13.8 ± 1.4 days, p > 0.05). Female sex and age > 41 years old correlated with longer time to band erosion and higher incidence of adverse events in SEMS patients. In SEPS group, only female sex was a risk factor for adverse events. Both procedures were efficient at inducing band erosion with similar safety profiles. Older and female patients are at a higher risk of treatment-related adverse events, especially those receiving SEMS.

Objectives The oncological outcomes, especially high recurrence rate, of bridge-to-surgery (BTS) self-expandable metallic stent (SEMS) placement remain concerning, emphasizing the necessity of standardized SEMS placement. However, its impact on long-term BTS outcomes is unknown. We investigated the long-term outcomes of BTS colonic stenting using standardized SEMS placement. Methods This prospective, multicenter cohort study conducted at 46 hospitals in Japan (March 2012-October 2013) included consecutive patients with stage II and III obstructive colorectal cancer managed with BTS SEMS placement. The SEMS placement technique was standardized by information dissemination among the participating hospitals. The primary outcome was overall survival (OS) after SEMS placement, and the secondary outcomes were relapse-free survival (RFS), recurrence, and short-term outcomes of SEMS placement and surgery. Results The 1-, 3-, and 5-year OS rates were 94.1%, 77.4%, and 67.4%(Kaplan-Meier), respectively, with high technical success (99.0%, 206/208) and low perforation (1.9%, 4/208) rates. The 1-, 3-, and 5-year RFS rates were 81.6%, 65.6%, and 57.9% (Kaplan-Meier), respectively, and the overall recurrence rate was 31.0% (62/200). The RFS rate was significantly poorer in patients with perforation (n = 4) than in those without perforation (n = 196) (log-rank p = 0.017); moreover, perforation was identified as an independent factor affecting RFS (hazard ratio: 3.31; 95% confidence interval: 1.03-10.71, multivariate Cox regression). Conclusions This large, prospective, multicenter study revealed satisfactory long-term outcomes of BTS colonic stenting using a standardized SEMS insertion method, which might be specifically due to reduced perforation rate. (UMIN000007953).

Although endobiliary radiofrequency ablation (RFA) may be an option for the treatment of ingrowth occlusion after self-expandable metal stent (SEMS) deployment, its utility remains uncertain. This study aimed to clarify its utility and safety using bovine liver.A prototype multifunctional RFA catheter and conventional uncovered SEMS were employed in this experimental study. We devised three model types: the ingrowth-ablation, ingrowth-ablation with stent-wire contact (created such that the electrodes were in contact with the metal stent-wire), and standard-ablation models (control). The study outcome was the ablation depth associated with RFA, which was compared among the three models.Thirty-six ablation procedures were conducted (12 for each of the 3 models). In the unipolar mode, the median ablation depth with the stent-wire contact model (1.0 mm) was significantly lower than that of the ingrowth-ablation (2.0 mm,In this

Biliary strictures can have several benign or malignant causes. We attempted to determine the usefulness of establishing a diagnosis using self-expandable metal stents (SEMS) in a prospective series of patients with suspected malignant biliary obstruction. Data of patients who underwent SEMS removal from August 2016 to December 2019 were collected. During this period, 55 patients underwent endobiliary biopsy and SEMS insertion and removal. Fifty-five consecutive patients (mean age, 69 years; range 53–90 years) were enrolled, and of these, 37 were male and 18 were female. A final diagnosis was established using biopsy specimens in 37 cases (67.3%) and surgical specimens in 6 cases (10.9%), with 12 cases (21.8%) diagnosed on radiological follow-up. The final diagnoses included malignancy in 34 cases (61.8%) and benign stricture in 21 cases (38.2%). Endobiliary biopsy had a sensitivity and specificity of 44.1% and 95.2%, whereas SEMS cytology had a sensitivity and specificity of 52.9% and 100%, respectively. Combining endobiliary biopsy and/or SEMS cytology yielded a sensitivity and specificity of 73.5% and 95.2%, respectively. (1) The use of biopsy results alone as a diagnostic tool yielded an area under the receiver operating characteristic curve (AUC) of 0.70 (0.60–0.79). (2) The addition of SEMS to the biopsy results yielded an AUC of 0.86 (0.78–0.94). (3) The addition of CA 19–9 levels to the biopsy results yielded an AUC of 0.81 (0.71–0.94). (4) Combining the endobiliary biopsy results, SEMS tissues, and CA 19–9 levels yielded the best diagnostic accuracy, with an AUC of 0.90 (0.83–0.98). Detection of biliary obstruction using the combination strategy was better than the diagnostic results based on biopsy alone according to recent 3-year data. Our study suggested that SEMS removal could help establish a diagnosis of suspected malignant biliary obstruction.

Few studies have investigated the long-term oncological outcomes of the self-expandable metallic stent (SEMS) as a bridge to surgery (BTS) for obstructive colorectal cancer (OCRC). We conducted this study to compare the short- and long-term outcomes of the SEMS with those of the traditional transanal decompression tube (TDT) in patients with stage II and III left-sided OCRC. The subjects of this retrospective study were 78 patients with pathological stage II and III left-sided OCRC who underwent radical surgery after SEMS or TDT placement, between April, 2005 and September, 2019. We compared perioperative data, including decompression success rates and 3-year relapse-free survival (RFS), between the SEMS and TDT groups. A SEMS was placed in 60 (76.9%) patients and a TDT was placed in 18 (23.1%) patients, achieving a clinical success rate of decompression of 98.3% in the SEMS group and 77.8% in the TDT group (P = 0.009). The 3-year RFS of the overall cohort was better in the SEMS group than in the TDT group (74.9% vs. 40.9%, respectively; P = 0.003). Decompression using a SEMS as the BTS may improve oncological outcomes over those achieved by a TDT in patients with left-sided stage II and III OCRC.

The study sought to compare the safety and effectiveness of drug-coated balloon (DCB) with bare nitinol stent in patients with complex femoropopliteal(FP) lesions in real-world practice.Patients with symptomatic (Rutherford stage 2 to 5) femoropopliteal lesions who underwent DCB or bare nitinol stent implantation at the Department of Cardiovascular Surgery of China-Japan Friendship Hospital from June 2016 to September 2017 were included. Demographics, angiographic and procedural variables were included. Freedom from target lesion revascularization (TLR), primary patency and major adverse events were obtained from follow-up results at 3,6 and12 months. Descriptive analysis was performed on all variables.A total of 90 eligible patients were enrolled, which included 51 DCB subjects (mean age, 63.1 ± 13.2 years; 76.5% male) with 55 lesions and 39 nitinol stent subjects (mean age, 66.5 ± 10.5 years; 61.5% male) with 42 lesions. Significant higher primary patency was observed in the DCB group compared with the stent group (74.5% vs. 52.4%; log-rank test P = 0.018; HR 0.335, 95%CI 0.124-0.903, P = 0.031). The rates of freedom from TLR (f-TLR) were 78.2% and 59.5% (log-rank test P = 0.032) for the DCB group and the stent group, respectively, at 12 months. CD-TLR rates were 18.2% vs. 38.1% with a P-value of 0.023. Female sex (HR 6.122, 95%CI 1.880-19.934, P = 0.003), lesion length over 20 cm (HR 5.514, 95%CI 2.312-13.148, P0.001) and renal insufficiency (HR 2.609, 95%CI 1.087-6.260, P = 0.032) were suggested as independent risk factors of reducing primary patency. There were no significant differences in major adverse events between the 2 groups.The result above demonstrates that DCB treatment has higher primary patency and lower TLR at 12 months than nitinol stent. These data confirm the safety and effectiveness of the DCB for patients with complex femoropopliteal lesions.

Background and aim Bilateral stent deployment for malignant biliary obstruction (MHBO) can be achieved using side-by-side (SBS) or stent-in-stent (SIS) procedures. Compared with SBS techniques, the procedural steps of SIS are technically complex due to the necessity of introducing the delivery system into a contralateral biliary tract through the mesh of the SEMS. To overcome this issue, a novel uncovered SEMS, the HILZO Moving Cell Stent (MCS) has been released. The present study examined the technical feasibility of treating MHBO using bilateral deployment of this novel stent without dilating the mesh of the first stent to achieve insertion of the second stent within a single session, using a prospective, multicenter setting. Method The primary outcome in the present study was the technical success rate. Technical success was defined as deployment of bilateral MCSs into two or more biliary tracts using SIS without a dilation device in a single-session. Results A total of 27 patients with complications of MHBO were enrolled in this study. Bilateral SIS using two MCS was successfully performed in 23 patients without using dilation devices among 27 patients (initial technical success rate; 85.2%). Median time to recurrent biliary obstruction (TRBO) was 271 days. Stent dysfunction was observed in 12 patients (44.4%), and re-intervention was successfully performed in all patients without one patient who instead received best supportive care. Conclusions The SIS technique using MCS without dilation of the mesh may be technically feasible and safe. In addition, this may be useful for re-intervention. Further comparative randomized trials are needed.

Endoscopic hilar multiple stenting is challenging. A 68-year-old patient had self-expandable metallic stents (SEMSs) inserted for unresectable hilar malignant biliary obstruction. After the SEMSs were inserted into the left hepatic duct and bile duct branch of segment (B) 6, a new SEMS with a wide mesh and slim delivery system was inserted into the right anterior hepatic duct. However, liver abscess and dilated B7 were observed on computed tomography; therefore, an additional new SEMS was quickly and easily inserted into B7. After the placement of these four SEMSs, the liver abscess improved. The new SEMS was effective for hilar multiple biliary drainage.

OBJECTIVE The literature suggests that blood-brain barrier disruption (BBBD) plays a significant role in the development of neurological events in patients with diffusion-weighted imaging (DWI) that is negative for lesions. In this prospective, single-center cohort study, the authors compared the imaging characteristics of patients suffering transient neurological events (TNEs) with those in patients suffering permanent neurological events (PNEs) after having undergone elective embolization of unruptured intracranial aneurysms. METHODS This prospective cohort study was conducted between July 2016 and June 2019. Inclusion criteria were adults undergoing elective neuroendovascular procedures and the absence of contraindications to MRI. All subjects underwent brain MRI including postcontrast FLAIR (pcFLAIR) sequences for evaluation of BBBD within 24 hours postprocedure. RESULTS In total, 128 patients harboring 133 unruptured aneurysms were enrolled, 109 of whom (85.2%) showed some degree of BBBD on pcFLAIR MRI and 50 of whom (39.1%) suffered an ischemic insult per DWI. In total, 23 patients (18%) suffered neurological complications, 16 of which (12.5%) were TNEs and 7 of which (5.5%) were PNEs. The median extent of BBBD was focal in asymptomatic patients as compared to hemispheric and lobar in the TNE and PNE groups, respectively (p < 0.001). The American Society of Anesthesiologists physical status classification predicted the extent of BBBD (p = 0.046). Lesions on DWI were noted in 34 asymptomatic patients (32.4%) compared to 9 patients (56.3%) with TNEs and all 7 patients (100%) with PNEs (p < 0.001). The median number of DWI lesions was 0 (range 0–18 lesions) in the asymptomatic group compared to 1.5 (range 0–8 lesions) and 8 (range 1–13 lesions) in the TNE and PNE groups, respectively (p < 0.001). Smoking (p = 0.008), older age (p = 0.002), and longer surgery (p = 0.006) were positively associated with the number of lesions on DWI. On multivariate analysis, intraarterial verapamil (p = 0.02, OR 8.01, 95% CI 1.35–47.43) and extent of BBBD (p < 0.001, OR 58.58, 95% CI 9.48–361.84) were positively associated with the development of TNEs, while intravenous infusion of midazolam during surgery (p = 0.02, OR 6.03, 95% CI 1.29–28.20) was negatively associated. An increased number of lesions on DWI was the only significant predictor for the development of PNEs (p < 0.001, OR 49.85, 95% CI 5.56–447.10). CONCLUSIONS An increasing extent of BBBD was associated with the development of TNEs, whereas an increasing number of lesions on DWI was significantly associated with the development of PNEs. BBBD imaging using pcFLAIR may serve as a valuable biomarker for detecting subtle cerebral ischemia and stratifying the risk for ischemic events.

Duodenal stenting has gradually been established as the first-line treatment for malignant gastric outlet obstruction (GOO). We encountered a case of duodenal stent fracture in a 76-year-old woman with gastric cancer and GOO. She underwent self-expandable metallic stent (SEMS) placement. The SEMS was found to be fractured 4 weeks after its placement. We removed the broken part of the stent and placed a second SEMS. SEMS fracture is a rare and - to the best of our knowledge - unreported complication; hence, clinicians and their patients should be aware of this possibility.

Background: Despite considerable morbid-mortality rates, common femoral endarterectomy is still considered the gold standard for atherosclerotic common femoral artery (CFA) disease. The aim of this study was to demonstrate computed tomography angiography based long-term patency after CFA stent placement and to analyze associated risk factors for restenosis. Methods: A retrospective and observational study was carried out in consecutive patients treated with endovascular stent placement in CFA lesions. A clinical follow-up and imaging study was performed using MD-CTA to assess different degrees of in stent restenosis (ISR) and primary, assisted, and secondary patency rates. Results: In a 5-year period, 35 extremities were treated in 33 patients with self-expandable nitinol stents. The technical success was 100% without complications related to the procedure. The mean follow-up (FU) was 32.2 months, and 8 limbs were lost. The degree of CFA stenosis was reduced from 79.69 ± 26.47% to 11.23 ± 24.53%. ISR < 20%, 20–70%, and ≥ 70% was evident in 15 (55.6%), 9 (33.3%), and 3 (11.1%) limbs, respectively. Estimated primary, assisted, and secondary patency was 79.5, 96.3, and 96.3%, respectively, after 24 months and 79.5, 96.3, and 96.3%, respectively after 60 months, with a freedom of clinical driven target lesion revascularisation rate of 87.8%. Conclusion: Endovascular treatment with self-expandable nitinol stents in CFA lesions had a high technical success rate and was related to few complications. A mild form of intimal hyperplasia was observed in a considerable number of cases. However, long-term patency was high; therefore, CFA stent placement might be a suitable therapeutic alternative in selected patients.

Multiple plastic stent (MPS) for biliary anastomotic stricture (AS) after liver transplantation requires multiple procedures with consequent costs. To compare the success, adverse events and treatment-related costs of fully covered self-expandable metal stents (FCSEMS) versus MPS. Thirty liver transplant (LT) patients with clinically relevant naive AS were prospectively randomized to FCSEMS or MPS, with stent numbers increased at 3-month intervals. Treatment costs per patient were calculated for endoscopic retrograde cholangiopancreatography (including all devices and stents) and overall hospital stay. Radiological success was achieved in 73% of FCSEMS (median indwelling period of 6 mos) and 93% of MPS patients (P = NS) (median period of 11 mos). AS recurrence occurred in 36% of FCSEMS and 7% of MPS patients (P = NS), and AS re-treatment was needed in 53% and 13% (P < 0.01), respectively, during follow-up of 60 (34-80) months. Stents migrated after 29% and 2.6% of FCSEMS and MPS procedures, respectively (P < 0.01). Including re-treatments, long-term clinical success was achieved in 28/30 (93%) patients. Overall treatment-related costs were similar between groups. In the subgroup of LT patients in clinical remission after first-line treatment, treatment costs were 41% lower per FCSEMS patient compared with MPS patients. FCSEMS did not perform better than MPS. FCSEMS migration increased the rate of re-treatment and costs.

Background The aim of this study was to evaluate the efficacy and safety of a novel self-expanding nitinol stent (Smartflex stent) in femoropopliteal artery obliterans disease. Methods From June 2016 to May 2019, patients with atherosclerotic occlusion disease of the superficial femoral and popliteal arteries using the Smartflex stents were retrospectively analyzed in our institution. Patients were monitored at 1, 3, 6, and 12 months and annually thereafter. The main characteristics of the diseased vessels, perioperative and follow-up outcome were evaluated. Kaplan-Meier method was used to assess patency rate and the rate of freedom from clinically driven target lesion revascularization (CD-TLR). Results A total of 50 limbs from 48 patients (mean age 69.4 ± 8.95 years; 38 men) were included. Eighty-eight Smartflex stents (1.76 stents per limb) were deployed successfully. Of the study patients, 82% had claudication (Rutherford III), 10% had rest pain (Rutherford IV), and 8% had tissue loss (Rutherford V). Trans-Atlantic Inter-Society Consensus II C and D lesions were 26% and 42%, respectively. The mean lesion length was 18.2 ± 8.5 cm and the mean stented length was 22.3 ± 9.9 cm. The average follow-up time was 16.4 ± 8.2 months. Of these lesions, 42 (94%) were chronic total occlusions and 16 (32%) were severely calcified. The primary patency rate at 1 year per Kaplan-Meier estimating, the rate of freedom from CD-TLR at 1 year, and the second patency rate was 83.3%, 88.1%, and 94%, respectively. Among them, 90% patients had improved ankle-brachial indexes (0.47 ± 0.13 before and 0.84 ± 0.16 after). No stent fractures and kinking were identified. Conclusions Stenting of the femoropopliteal artery diseases using the Smartflex stent appeared to be safe and effective. It performed well in long-segment and above knee joint lesions.

Introduction Superior vena cava (SVC) syndrome (SVCS) is a life-threatening occurrence that necessitates prompt treatment. At present, endovascular stenting is proposed as a first-line treatment to relieve symptoms. We assessed the effectiveness, safety and outcome of SVC stent positioning in patients affected with advanced cancer. Methods Forty-two patients undergoing stent positioning in the SVC for neoplasms from January 2002 to December 2018 form the basis of this retrospective study. Demographic data, risk factors, associated diseases, symptoms at presentation according to the score proposed by Kishi and the type of SVCS according to Sanford and Doty were collected. Minor and major complications were recorded. Suspected stent occlusion was confirmed by means of recurrence of symptoms followed by a confirmatory computed tomography (CT). Results Thirty-four (81%) patients had a nonresectable lung tumour invading or compressing the SVC. Five (12%) patients had a non-Hodgkin's lymphoma, and three (7%) had metastatic lymphadenopathies. Nitinol stents (Memotherm®) were employed in 19 (45%) patients, and steel stents (Wallstent™) in the remaining 23 (55%) patients. Thirty-five (85%) patients died during follow up for disease progression and the overall survival rate at 24 months was 11% (standard error (SE)=0.058). Thirteen patients (32%) had a recurrence of SVCS because of stent thrombosis in three (23%) and extrinsic compression from uncontrolled cancer progression in ten (77%). The overall symptom-free interval at 24 months was 57% (SE=0.095). Conclusions We recommend the use of the endovascular procedure as a first-line treatment in locally advanced or metastatic tumour in the presence of SVCS.

Objective The NeVa M1 thrombectomy device is a novel hybrid-cell stent retriever with multifunctional zones for optimized retrieval of resistant clots located in the M1 segment of the middle cerebral artery. The objective was to evaluate the safety and efficacy of the NeVa in a “real-life” setting. Methods Twenty-nine consecutive patients (median age: 77 years) treated with the NeVa M1 for acute ischemic stroke of the M1 segement were retrospectively reviewed. First-pass and final modified thrombolysis in cerebral infarction (mTICI) scores, device-related complications, symptomatic intracranial hemorrhage, and 90-day modified Rankin scale (mRS) scores are reported. Primary outcome parameters were first-pass mTICI 2b-3 reperfusion and mRS 0–2 at 90 days. Results Median National Institutes of Health Stroke Scale scores decreased from 16 to 12 after treatment. mTICI 2b-3 reperfusion rates were 55% after the first pass, 79% after 1–2 passes, and 100% after the final pass. mTICI 2c-3 was obtained in 48% after the first pass, 62% after 1–2 passes, and 72% after the final pass. Rescue treatment was performed in 4 patients (14%). Device-related complications included 1 asymptomatic caroticocavernous fistula, 1 asymptomatic M2 dissection, and 1 symptomatic intracranial hemorrhage. The procedure-related vasospasm rate was 48%. A 90-day mRS of 0–2 was achieved by 31%. Conclusions The NeVa M1 provides a high first-pass complete reperfusion rate with an adequate safety profile. To retrieve resistant clots, the stent design exerts high mechanical traction forces, which may trigger vasospasm and vessel wall damage. Large, comparative studies are warranted to draw a definite conclusion on this device.

Several investigations on the feasibility of stent placement into the Eustachian tube (ET) are being conducted. However, stents optimized for the anatomical structure of the ET have not yet been developed. In this study, the efficacy and safety of a self-expandable metallic stent (SEMS) optimized for porcine ET morphology was investigated. Silicone was injected into a cadaveric porcine ET to analyze the ET morphology. The three-dimensional-reconstructed porcine ET phantom images obtained after a computed tomography scan were measured to determine the dimensions of the porcine ET. The SEMS was designed as a tapered structure on the basis of the morphological findings of the porcine ET. The tapered SEMS (T-SEMS) and conventional SEMS (C-SEMS) were placed into the porcine ET to compare the safety and efficacy of the two types of SEMSs. Stent-induced tissue hyperplasia in the T-SEMS group was significantly lower than that in the C-SEMS group (p

Bilio-duodenal bleeding, such as post-endoscopic sphincterotomy (EST) bleeding, common bile duct (CBD) bleeding after endoscopic retrograde cholangiopancreatography (ERCP), and duodenal bleeding due to malignant tumour invasion, can sometimes become severe. Six cases of refractory bilio-duodenal bleeding were stanched via covered self-expandable metallic stent (CSEMS) insertion, even though three of the patients had a history of gastrectomy. The dumbbell-shaped CSEMS was useful for managing post-EST bleeding. Additional duodenal CSEMS insertion was useful for the patient who had previously undergone uncovered SEMS insertion, and no migration of the CSEMS was observed. CSEMS insertion was useful for treating refractory bilio-duodenal haemorrhaging.

BackgroundFlow diverters (FDs) are effective in the treatment of carotid aneurysms. Compared with carotid aneurysms, the treatment of distal intracranial aneurysms with FDs has been associated with a relatively high incidence of complications. Low thrombogenic modified-surface FDs may reduce ischemic complications and allow for the use of a single antiplatelet medication. The aim of this study was to assess the safety and efficacy of the p48 MW HPC Flow Modulation Device (Phenox GmbH, Bochum, Germany) to treat distal intracranial aneurysms used in combination with prasugrel monotherapy.MethodsThis was a single-center, prospective, pivotal, open, single-arm study. Patients were included in this study from December 2019 to September 2020. The primary endpoints were the incidence of any neurologic deficit after treatment until 1 month of follow-up, defined as National Institutes of Health Stroke Scale (NIHSS) ≥1, and the incidence of acute ischemic lesions in magnetic resonance imagin (MRI) images 48 hours after treatment. The secondary endpoint was the rate of complete occlusion of the aneurysms at the 1-month follow-up.ResultsTwenty-one patients harboring 27 distal aneurysms of the anterior circulation were included. Mean age was 57.8 (SD 9.7) years, and 16 patients were female (80%). No patient had neurologic symptoms at the 1-month follow-up. Four patients (20%) had asymptomatic acute brain ischemic lesions on MRI. Complete aneurysm occlusion occurred in 9/27 (33.3%) aneurysms at the 1-month follow-up.ConclusionIn this pilot safety trial, treatment of distal intracranial aneurysms with p48 MW HPC under monotherapy with prasugrel appeared to be safe.

Objectives This single-center comparative randomized superiority study compared biliary stenting using fully covered self-expandable metal stents (FCSEMS) and biliary stenting using plastic stents (PS) in preoperative biliary drainage of patients with borderline resectable pancreatic cancer (BRPC) who are planned to undergo a single regimen of neo-adjuvant chemotherapy (NAC). Methods Twenty-two patients with BRPC who required preoperative biliary drainage before NAC (Gemcitabine plus Nab-paclitaxel) were randomly assigned 1:1 to the FCSEMS or PS group. The primary endpoint was the rate of stent dysfunction until surgery or tumor progression. Secondary endpoints were stent patency, number of re-interventions, adverse events of endoscopic retrograde biliary drainage (EBD), operation time, volume of intraoperative bleeding, postoperative hospitalization, postoperative adverse events and medical costs. Results Eleven patients in each of the groups reached the primary endpoint. The FCSEMS group showed a significantly lower rate of stent dysfunction (18.2% vs. 72.8%, P = 0.015), longer stent patency (P = 0.02), and lower number of re-interventions for stent dysfunction (0.27 ± 0.65 vs. 1.27 ± 1.1, P = 0.001) than the PS group. The adverse events of EBD, operation time, volume of intraoperative bleeding, postoperative hospitalization, postoperative adverse events and medical costs did not significantly differ between the two groups. Conclusions In patients with BRPC for preoperative biliary drainage, stent dysfunction occurred less frequently with FCSEMSs than with PSs. In addition, FCSEMS and PS provided similar preoperative management of BRPC in terms of the safety of surgery and medical costs. (UMIN ID000030473).

Background : : Malignant afferent loop syndrome occurs after biliary reconstruction and is difficult to treat because of the complicated anatomical changes. The aim of this study was to investigate the safety and efficacy of percutaneous metallic stent placement for malignant afferent loop syndrome via the blind end of the jejunal limb after biliary reconstruction. Methods : : Percutaneous metallic stent placement via the jejunal limb was performed in five male patients (median age, 68 years; range, 51–88 years) with malignant afferent loop syndrome following pancreatoduodenectomy or bile duct resection with reconstruction at our institute from June 2009 to April 2019. Reconstruction was performed using a modified Child’s method or the Roux-en-Y method, and blind end of the jejunal limb was surgically fixed to the abdominal wall. Percutaneous drainage of the afferent loop was performed via the blind end of the jejunal limb. Subsequently, percutaneous metallic stent placement was performed via the same route. Technical success, clinical success, and complications were retrospectively evaluated. Results : : Percutaneous metallic stent placement via the blind end of the jejunal limb was successfully achieved in all six procedures. Additional metallic stent placement was performed due to tumor ingrowth in a patient. Drainage catheters were removed from three patients, clamped in one, and could not be removed in one. Clinical success was achieved in four patients (80%) without major complications. Conclusion : : Percutaneous metallic stent placement for malignant afferent loop syndrome via the blind end of the jejunal limb after biliary reconstruction could be a safe and effective procedure.

During intracranial aneurysm embolization with the Pipeline embolization device (PED), ischemic and hemorrhagic complications have been observed in cases among Western populations. The postmarket multicenter registry study on the embolization of intracranial aneurysms with the PED in China, i.e., the PLUS study, was performed to assess real-world predictors of complications and functional outcomes in patients treated with the PED in a Chinese population. All patients with intracranial aneurysms who underwent embolization using the PED between November 2014 and October 2019 across 14 centers in China were included. The study endpoints included preoperative and early postoperative ( 10 mm, distal anterior circulation aneurysms, and adjunctive coiling were found to be independent predictors of delayed aneurysm rupture, distal intraparenchymal hemorrhage, and neurological compression symptoms, respectively. The rate of PED-related complications in the PLUS study was similar to that in Western populations. The PLUS study identified successful deployment after adjustment or unsuccessful device deployment and the degree of immediate postoperative occlusion as novel independent predictors of PED-related ischemic stroke in a Chinese population. ClinicalTrial.gov Identifier: NCT03831672 SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s13311-020-00990-8.

To evaluate the efficacy of a silver nanoparticle (AgNP)-coated self-expandable metallic stent (SEMS) for suppressing tissue hyperplasia in a rat esophageal model.Twenty-four male Sprague-Dawley rats were randomly assigned to four groups. Animals in group A underwent uncoated SEMS placement, whereas animals in groups B, C, and D underwent 6, 12, and 24 mg/mL AgNP-coated SEMS placement, respectively. All animals were euthanized 4 weeks after SEMS placement, and a gross examination and histological analyses were performed.All rats achieved technical success and survived until the end of the study. The gross examination showed moderate to severe tissue hyperplasia in 5 rats in group A and 2 rats in group B. In contrast, no animals in groups C and D had moderate or severe tissue hyperplasia. The gross examination revealed no complications. The percentage of granulation tissue area, number of epithelial layers, thickness of submucosal fibrosis, percentage of connective tissue area, inflammatory cell infiltration grade, degree of collagen deposition, and degrees of Ki67, TUNEL, and α-SMA-positive deposition were significantly lower in groups C and D than in group A (all p 0.05). However, only the percentage of granulation tissue area, number of epithelial layers, thickness of submucosal fibrosis, and percentage of connective tissue area were significantly lower in group B than in group A (all p 0.05). No histological parameters were significantly different between group D and group C (all p 0.05).AgNP-coated SEMSs suppressed tissue hyperplasia in a rat esophageal model.

BACKGROUND Intrasaccular flow-disruption represents a new paradigm in endovascular treatment of wide-necked bifurcation aneurysms. OBJECTIVE To retrospectively compare Woven Endobridge (WEB) embolization with microsurgical clipping for unruptured anterior circulation aneurysms using propensity score adjustment. METHODS A total of 63 patients treated with WEB and 103 patients treated with clipping were compared based on the intention-to-treat principle. The primary outcome measures were immediate technical treatment success, major adverse events, and 6-mo complete aneurysm occlusion. RESULTS The technical success rates were 83% for WEB and 100% for clipping. Procedure-related complications occurred more often in the clipping group (13%) than the WEB group (6%, adjusted P

ObjectivesThe purpose of this study was to evaluate the results of combining superficial femoral artery endovascular therapy with distal bypass originating from the popliteal artery as a method of lower extremity revascularization in patients with chronic limb-threatening ischemia.MethodsThe records of patients undergoing combined superficial femoral artery endovascular therapy with popliteal-to-distal bypass for chronic limb-threatening ischemia from January 2014 to April 2020 at a single institution were retrospectively reviewed. The patients’ background, operative details, and long-term outcomes were analyzed.ResultsFifty-two popliteal-to-distal bypasses with superficial femoral artery endovascular therapy were performed in 49 patients (33 men; mean age, 76 ± 9 years; diabetes mellitus, 80%; end-stage renal disease with hemodialysis, 47%). The Trans-Atlantic Inter-Society Consensus II classification of superficial femoral artery–popliteal lesion was “A” in 8 (15%) patients, “B” in 14 (27%) patients, “C” in 24 (46%) patients, and “D” in 6 (12%) patients. The intervention for superficial femoral artery lesions was plain old balloon angioplasty in 4 patients, self-expandable nitinol stent in 15 patients, drug-coated balloon in 18 patients, drug-eluting stent in 4 patients, stent graft in 10 patients, and interwoven nitinol stent in 1 patient. Distal bypass originated from the above-knee popliteal artery in 9 (17%) limbs and the below-knee popliteal artery in 43 (83%) limbs. The most common outflow artery was the posterior tibial artery (44%). The mean follow-up period was 17 ± 17 months. The primary and secondary patency of the graft was 44% and 72%, respectively, at 1 year and 39% and 72%, respectively, at 3 years. Primary patency and freedom from clinical-driven target lesion revascularization of superficial femoral artery endovascular therapy lesions were 85% and 90%, respectively, at 1 year and 63% and 75%, respectively, at 3 years. Limb salvage was 97% at 1 year and 92% at 3 years. Wound healing was 67% at 6 months and 83% at 12 months.ConclusionsCombined superficial femoral artery endovascular therapy with popliteal-to-distal bypass may be a promising approach for patients with chronic limb-threatening ischemia because of durable patency, acceptable wound healing, and good limb salvage.

Introduction Self-expandable metal stents (SEMS) are a known treatment option for obstruction due to colorectal cancer. The objective of this project was to estimate the usage of such stents in Iceland between 2000-2018. We evaluated the number of patients who received the stent as a bridge to surgery (BtoS) or as a palliative therapy (PT) and evaluated complication rate and the technical and clinical success rate. Material and methods Retrospective review of patients in Landspitali University Hospital who received SEMS for malignant colorectal obstruction. Search was conducted using diagnostic and theraputic codes in the Icelandic electronic medical record system. Results A total of 43 patients with colorectal cancer received in total 53 SEMS for obstruction, the first patient in 2005. More patient received SEMS as PT (n=27) than as BtoS (n=16). Colon perforation occurred in 5 patients (12%). A resection with primary anastomosis was performed in 69% of the BtoS patients. The majority of the PT patients did not receive an operation (63%). Permanent stoma ratio was 27% for BtoS patients and 22% for PT patients. Conclusion SEMS served as BtoS with resection and primary anastomosis for the majority of patients in the BtoS group. For a majority of patients in the PT group, SEMS could be used to avoid surgery. The perforation rate was relatively high. Information on techincal and clinical success was poorly recorded. Because of the retrospective nature of the study and the small population size all results should be interpreted with caution.

Objective The left subclavian artery (LSA) origin can be intentionally covered by stent grafts, to provide adequate proximal landing zones during thoracic endovascular repair for Stanford type B aortic dissections (TBADs). To preserve the LSA, a novel single branched stent graft, named “Castor” was designed and a clinical trial conducted to investigate its suitability. Methods From April 2013 to March 2015, 73 patients with TBAD were treated by Castor stent grafts at 11 Chinese tertiary hospitals as part of a single arm prospective clinical trial. There were 50 acute ( 2 weeks [31.5%]). Results The technical success rate was 97% (n = 71/73). The two failures were caused by occlusion of the branch section of the stent graft. There were four intra-operative endoleaks (two type Ia, two type B from the LSA). The endoleak rate was 5% (n = 4/73). There was one in hospital death and no major complications. The median follow up time was 61 months (range 48–72 months). The mortality was 5% (n = 4/73) within one year and 7% within six years (n = 5/73). Two deaths were of unknown cause and three were not related to the aorta. Two new entry tears were found on the proximal or distal edge of the stent graft and were retreated endovascularly. Six occlusions of the branch section of the Castor stent graft were found, and the follow up patency rate of the branch section was 93% (n = 63/68). Two intra-operative endoleaks were left during follow up and eventually disappeared according to the latest computed tomography angiograms. Conclusion For patients with TBADs needing anchoring proximal to the origin of LSA, the Castor single branched stent graft may provide an easily manipulated, safe, and effective endovascular treatment.

Background Endoscopic ultrasound (EUS)-guided biliary drainage is becoming an option for palliation of malignant biliary obstruction. Lumen-apposing metal stents (LAMS) are replacing self-expandable metal stents (SEMS). The aim of this meta-analysis was to evaluate the efficacy and safety of LAMS and SEMS for EUS-guided choledochoduodenostomy (EUS-CDS). Methods A meta-analysis was performed using PRISMA protocols. Electronic databases were searched for studies on EUS-CDS. The primary outcome was clinical success. Secondary outcomes were technical success, reintervention, and adverse events. We used the random effects model with the DerSimonian–Laird estimation, and the results were depicted using forest plots. Subgroup analyses were also performed with data stratified by selected variable. Results Overall, 31 studies (820 patients) were included. The pooled rates of clinical and technical success were 93.6 % (95 % confidence interval [CI] 88.6 %–96.5 %) and 94.8 % (95 %CI 90.2 %–97.3 %) for LAMS, and 91.7 % (95 %CI 88.1 %–94.2 %) and 92.7 % (95 %CI 89.9 %–94.9 %) for SEMS, respectively. The pooled rates of adverse events were 17.1 % (95 %CI 12.5 %–22.8 %) for LAMS and 18.3 % (95 %CI 14.3 %–23.0 %) for SEMS. The pooled rates of reintervention were 10.9 % (95 %CI 7.7 %–15.3 %) for LAMS and 13.9 % (95 %CI 9.6 %–19.7 %) for SEMS. Subgroup analyses confirmed these results. Conclusions This meta-analysis showed that LAMS and SEMS are comparable in terms of efficacy for EUS-CDS. Clinical and technical success, post-procedure adverse events, and reintervention rates were similar between LAMS and SEMS use; however, adverse events require further investigation.

ObjectiveStenting is an established endoscopic therapy for malignant gastric outlet obstruction (mGOO). The choice of stent (covered vs uncovered) has been examined in prior randomised studies without clear results.DesignIn a multicentre randomised prospective study, we compared covered (CSEMS) with uncovered self-expandable metal stents (UCSEMS) in patients with mGOO; main outcomes were stent dysfunction and patient survival, with subgroup analyses of patients with extrinsic and intrinsic tumours.ResultsOverall survival was poor with no difference between groups (probability at 3 months 49.7% for covered vs 48.4% for uncovered stents; log-rank for overall survival p=0.26). Within that setting of short survival, the proportion of stent dysfunction was significantly higher for uncovered stents (35.2% vs 23.4%, p=0.01) with significantly shorter time to stent dysfunction. This was mainly relevant for patients with extrinsic tumours (stent dysfunction rates for uncovered stents 35.6% vs 17.5%, pConclusionsDue to poor patient survival, minor differences between covered and uncovered stents may be less relevant even if statistically significant; however, subgroup analysis would suggest to use covered stents for intrinsic and uncovered stents for extrinsic malignancies.

Single-balloon enteroscopy-assisted endoscopic retrograde cholangiopancreatography (SBE-ERCP) has been increasingly performed for the treatment of malignant biliary obstruction (MBO) in patients with surgically altered anatomy (SAA), however evidence is scarce. Therefore, we conducted this study to evaluate the efficacy and safety of self-expandable metallic stent (SEMS) placement using a short type SBE.We retrospectively examined consecutive patients with SAA who received initial SEMS for MBO at our institution between February 2016 and February 2019. We evaluated patient characteristics, technical and functional success rates, time to recurrent biliary obstruction (TRBO) and complications according to the location of the biliary stricture.A total of 26 patients were included in this study. The primary tumor was gastric cancer in 12, pancreatic cancer in 6, cholangiocarcinoma in 6 and gallbladder cancer in 2. The biliary stricture site was distal bile duct in 14, hilar bile duct in 3 and hepaticojejunostomy (HJ) anastomosis in 9. Technical and functional success rates were 92 and 88%, respectively. TRBO, median survival time, overall rate of RBO and early complications were not different according to the stricture site (SEMS placement

IntroductionDespite a decade of research into virtual stent deployment and the post-stenting aneurysmal hemodynamics, the hemodynamic factors which correlate with successful treatment remain inconclusive. We aimed to examine the differences in various post-treatment hemodynamic parameters between successfully and unsuccessfully treated cases, and to quantify the additional flow diversion achievable through stent compaction or insertion of a second stent.MethodsA systematic review and meta-analysis were performed on eligible studies published from 2000 to 2019. We first classified cases according to treatment success (aneurysm occlusion) and then calculated the pooled standardized mean differences (SMD) of each available parameter to examine their association with clinical outcomes. Any additional flow diversion arising from the two common strategies for improving the stent wire density was quantified by pooling the results of such studies.ResultsWe found that differences in the aneurysmal inflow rate (SMD −6.05, 95% CI −10.87 to −1.23, p=0.01) and energy loss (SMD −5.28, 95% CI −7.09 to −3.46, pConclusionsInflow rate and energy loss have shown promise as identifiers to discriminate between successful and unsuccessful treatment, pending future research into their diagnostic performance to establish optimal cut-off values.

BackgroundIndications for flow diversion stent (FDS) treatment are expanding. However, there is still a lack of evidence for the long-term outcome in distally located aneurysms in the M2 segment of the middle cerebral artery (MCA) and beyond.MethodsConsecutive subjects (from June 2013 to August 2020) with MCA aneurysms in the M2 segment or beyond treated with FDS were reviewed retrospectively. The primary endpoints for clinical safety were the absence of mortality, stroke event, re-rupture of the aneurysm, and worsening of clinical symptoms. The primary endpoint for treatment efficacy was complete/near-complete occlusion at follow-up after 12 months.Results23 patients were identified: 7 aneurysms were located in the M2 segment of the MCA, 4 in the M2-M3 bifurcation, 2 in M3, 3 in M3-4 branching, and 2 in M4; 5 aneurysms were located in M2 with extension into the M1-M2 bifurcation. 13 aneurysms were of fusiform morphology, 8 sacculofusiform, and 2 saccular. 16 aneurysms were of highly suspected dissecting etiology. The median diameter of the parent vessel was 2.1 mm proximally and 2 mm distally. The median time of the follow-up was 30 months (range 16 months to 6 years). Complete/near complete occlusion was observed in 14/20 patients (70%) and one stable remodeling (5%) was seen at 12 months. 22 patients (95.6%) had an excellent clinical outcome (mRS 0–1) at 6 months. Technical challenges associated with the deployment of FDS occurred in 8.7% of cases. Severe complications, intraparenchymal hemorrhage and re-rupture of the aneurysm occurred in 2 patients (8.7%).ConclusionFlow diversion of distally located aneurysms is technically feasible with low morbidity and mortality.

Placement of self-expanding metal stents (SEMS) has emerged as a minimally invasive treatment option for esophageal perforation and leaks. The aim of our study was to assess the role of SEMS for the management of benign esophageal diseases such as perforations and anastomotic leaks. All patients (n = 26) who underwent SEMS placement for esophageal perforation and anastomotic leaks between May 2012 and February 2019 were included. Data were analyzed in relation to the indications, type of stent used, complications, and outcomes. Indications for stent placement included anastomotic leaks 65% (n = 17) and perforations 35% (n = 9). Fully covered SEMS (FCSEMS) was placed in 25 patients, and in 1, partially covered SEMS (PCSEMS) was placed. Stent placement was successful in all the patients (n = 26). Four patients did not report for follow-up after stenting. Among the patients on follow-up, 91% (20/22) had healing of the mucosal defect. Stent-related complications were seen in 5 (23%) patients and included stent migration [3], reactive hyperplasia [1] and stricture [1]. Covered stent placement for a duration of 8 weeks is technically safe and clinically effective as a first-line procedure for bridging and healing benign esophageal perforation and leaks.

BackgroundHigh-frequency optical coherence tomography (HF-OCT) is an intra-vascular imaging technique capable of assessing device-vessel interactions at spatial resolution approaching 10 µm. We tested the hypothesis that adequately deployed Woven EndoBridge (WEB) devices as visualized by HF-OCT lead to higher aneurysm occlusion rates.MethodsIn a leporine model, elastase-induced aneurysms (n=24) were treated with the WEB device. HF-OCT and digital subtraction angiography (DSA) were performed following WEB deployment and repeated at 4, 8, and 12 weeks. Protrusion (0-present, 1-absent) and malapposition (0-malapposed, 1-neck apposition >50%) were binary coded. A device was considered ‘adequately deployed’ by HF-OCT and DSA if apposed and non-protruding. Aneurysm healing on DSA was reported using the 4-point WEB occlusion score: A or B grades were considered positive outcome. Neointimal coverage was quantified on HF-OCT images at 12 weeks and compared with scanning electron microscopy (SEM).ResultsAdequate deployment on HF-OCT correlated with positive outcome (P=0.007), but no statistically significant relationship was found between good outcome and adequate deployment on DSA (P=0.289). Absence of protrusion on HF-OCT correlated with a positive outcome (P=0.006); however, malapposition alone had no significant relationship (P=0.19). HF-OCT showed a strong correlation with SEM for the assessment of areas of neointimal tissue (R²=0.96; PConclusionHF-OCT visualizes features that can determine adequate device deployment to prognosticate early aneurysm occlusion following WEB implantation and can be used to longitudinally monitor aneurysm healing progression.

We report 8-year experience with vascular access complications (VACs) after percutaneous transfemoral transcatheter aortic valve implantation (TAVI). From January 2010 to January 2018, patients with iliofemoral VAC treated by an intervention following percutaneous transfemoral TAVI were included. Major VAC was defined according to the Valve Academic Research Consortium 2 classification. As first-line strategy, VACs were treated using covered nitinol stents (CS). Among 795 percutaneous transfemoral TAVI, 74 (9.3%) patients (female, 57%; 82 ± 8 years) with VAC treated by CS and/or open repair were included in this study: 59 CS cases and 15 open repair cases. Two CS patients were converted to open repair. Technical success for stent implantation was 97%. The main VAC was a persistent bleeding related to percutaneous closure device failure (72%). Thirty-day mortality in the study cohort was 5.4% (4/74), including 1 VAC-related death. One patient had postoperative lower limb ischemia successfully treated by open repair. No amputation, new-onset claudication or in-stent occlusion was recorded. Endovascular intervention using self-expandable nitinol covered stent is safe and effective as a first-line strategy for the treatment of VAC in percutaneous transfemoral TAVI. However, open repair is needed in case of unfeasibility or failure of endovascular therapy.

Stent migration is one of the main drawbacks of covered self-expandable metal stent (SEMSs), occurring in up to 40% of malignant colorectal obstruction management cases. Various types of covered SEMSs have been developed to reduce this risk. We aimed to compare the effectiveness and complication rates of the flare-type covered SEMS (Flare) with those of the double-layered covered SEMS (ComVi). We performed a prospective, randomized study in four tertiary referral centers between July 2016 and April 2018. Patients with malignant colorectal obstruction were eligible for the study. The primary outcome was migration rate as observed within the first month. Rates of technical success, clinical success, and complications within the first month were also assessed. A total of 60 patients were included (mean age, 70.5 ± 12.5 years; male, 31 [51.7%]). Flare and ComVi stents were applied in 30 patients each. The Flare and ComVi groups showed comparable technical success rates (90% [27/30] vs. 96.7% [29/30], p = 0.605) and clinical success rates (85.2% [23/27] vs. 75.9% [22/29], p = 0.589). Migration occurred in three (11.1%) and four (13.8%) cases in the Flare and ComVi groups, respectively, without significant difference (p = 0.99), and the risk of other complications, including perforation and re-obstruction, did not differ between the two groups. Our study indicates that both flare-shape and double-layered covered SEMSs are equally effective options for the management of malignant colorectal obstruction with low migration rates when compared with previously reported migration risk of covered SEMS.

Background A low-profile visualized intraluminal support (LVIS) device may incompletely expand during stent deployment in tortuous vessels. However, the cause of incomplete expansion remains uninvestigated. We aimed to examine in vitro the factors causing incomplete expansion in LVIS deployment by using various vessel models. Methods A linear model group was created by connecting linear silicone tubes (inner diameter 4 mm) at both sides of the LVIS deployment vessel (inner diameter 4 mm) with different curvature angles of 10–140° at 10° intervals. For comparison, proximal and distal bending model groups were created, both with 90° bending on the proximal/distal larger curvature side of the deployment vessel. A single operator macroscopically deployed an LVIS (4.5×32 mm) four times in each model and 56 times in each group. Results In each model group the LVIS deployment vessel with a narrow curvature angle incompletely expanded. Incomplete expansion occurred significantly more frequently in the distal bending model group (34%, 19/56) compared with that in the linear model group (14.3%, 8/56; p Conclusions Factors such as acute angle, distal bending, and proximal bending of the deployment vessel can cause incomplete LVIS expansion.