The TOPOS study.

Background: We aimed to study the long-term safety and efficacy of oblique venous stents for post-thrombotic syndrome (PTS) with iliac vein compression. Patients and methods: In the multinational, prospective, single-arm TOPOS study, PTS patients scheduled for endovascular therapy with the sinus-Obliquus® stent and optional distal extension with the sinus-Venous® or sinus-XL Flex® stent were enrolled at eight European vascular centres between October 2016 and December 2020. The primary outcome was primary stent patency at 24 months, and secondary outcomes included the clinical course of PTS (Villalta score, revised Venous Clinical Severity Score [rVCSS], Visual Analog Scale [VAS] of pain), quality of life changes (Chronic Venous Insufficiency Quality of Life Questionnaire, CIVIQ-20), and device-related complications. Results: We enrolled 60 patients (mean age 46±15 years, 68% women, 13% active ulcers): 80% required stent extension (70% below the inguinal ligament). The primary patency rate at 24 months was 80.7% (95%CI 68.1-90.0%); it was higher in patients without vs. those with stent extension (90.9% vs. 78.3%, p=.01). Compared to baseline, the Villalta, rVCSS, pain VAS, and CIVIQ-20 decreased by a median of 8 (interquartile range (IQR): 4-11), 5 (IQR: 3-7), 3 (IQR: 2-5), and 17 (IQR: 6-22) points, respectively; p<.001 for all parameters. Overall, 9 events of acute stent occlusion, 4 symptomatic stent stenosis, and 1 pulmonary embolism occurred. We did not observe major bleeding events or contralateral thrombosis. Conclusions: Endovascular treatment with the oblique stent and optional stent extension was safe and resulted in high patency rates at 24 months. The reduction in PTS severity was substantial and persisted over 2-year follow-up.

6-mm shunt transjugular intrahepatic portosystemic shunt in patients with severe liver atrophy and variceal bleeding.

OBJECTIVES: We proposed a strategy for the creation of a 6-mm transjugular intrahepatic portosystemic shunt (TIPS) and to assess its effectiveness compared to a conventional 8-mm shunt for TIPS-induced hepatic encephalopathy (HE). METHODS: Patients were reviewed retrospectively using propensity score matching (1:1) and divided into 6-mm and 8-mm shunt groups based on shunt diameter. The stent patency, HE incidence, and rebleeding rate between the two groups were then compared. RESULTS: From January 2018 to June 2021, both 6-mm shunt group and 8-mm shunt group included 58 patients. The 6-mm shunt group had significantly smaller liver volumes (879.3 ± 237.1 vs. 1008.8 ± 293.0; p = 0.010), and the median stent patency times were 30.7 and 33.8 months in the 6-mm and 8-mm groups, respectively (p = 0.124). No statistically significant difference was found between the two groups in the 1-year (8.6% vs. 3.4%; p = 0.242) and 2-year (17.2% vs. 12.1%; p = 0.242) rebleeding rates. The 1-year cumulative incidences of overt HE were 12.1% and 27.6% in the 6-mm and 8-mm groups, respectively (p = 0.040), and the 2-year cumulative overt HE incidences in these groups were 19.0% and 36.2%, respectively (p = 0.038). Notably, patients with a 6-mm shunt also experienced less hepatic impairment. CONCLUSIONS: For patients with variceal bleeding and a small liver volume, the 6-mm shunt significantly reduced the incidence of overt HE, protected perioperative liver function, and did not affect stent patency or rebleeding rate. CLINICAL RELEVANCE STATEMENT: For patients with variceal bleeding with small liver volume, the 6-mm transjugular intrahepatic portosystemic shunt (TIPS) significantly reduced the incidence of overt hepatic encephalopathy after TIPS, protected perioperative liver function, and did not affect stent patency and rebleeding rate. KEY POINTS: • A strategy for the creation of a 6-mm transjugular intrahepatic portosystemic shunt for patients with variceal bleeding and a small liver volume was proposed. • The 6-mm transjugular intrahepatic portosystemic shunt significantly reduced the incidence of overt hepatic encephalopathy. • The 6-mm transjugular intrahepatic portosystemic shunt did not affect stent patency or rebleeding rate.

Impact of a shorter replacement interval of plastic stents on premature stent exchange rate in benign and malignant biliary strictures.

BACKGROUND AND AIM: The main disadvantage of plastic stents is the high rate of stent occlusion. The usual replacement interval of biliary plastic stents is 3 months. This study aimed to investigate if a shorter interval of 6-8 weeks impacts the median premature exchange rate (mPER) in benign and malignant biliary strictures. METHODS: All cases with endoscopic retrograde cholangiopancreatography (ERCP) and plastic stent placement were retrospectively analyzed since establishing an elective replacement interval of every 6-8 weeks at our institution and mPER was determined. RESULTS: A total of 3979 ERCPs (1199 patients) were analyzed, including 1262 (31.7%) malignant and 2717 (68.3%) benign cases, respectively. The median stent patency (mSP) was 41 days (range 14-120) for scheduled stent exchanges, whereas it was 17 days (1-75) for prematurely exchanged stents. The mPER was significantly higher for malignant (28.1%, 35-50%) compared with benign strictures (15.2%, 10-28%), P < 0.0001, respectively. mSP was significantly shorter in cases with only one stent (34 days [1-87] vs 41 days [1-120]) and in cases with only a 7-Fr stent (28 days [2-79]) compared with a larger stent (34 days [1-87], P = 0.001). Correspondingly, mPER was significantly higher in cases with only one stent (23% vs 16.2%, P < 0.0001) and only a 7-Fr stent (31.3% vs 22.4%, P = 0.03). CONCLUSION: A shorter replacement interval does not seem to lead to a clinically meaningful reduction of mPER in benign and malignant strictures. Large stents and multiple stenting should be favored as possible.

Enteral extended biliary stents versus conventional plastic biliary stents for the treatment of extrahepatic malignant biliary obstruction: a single-center prospective randomized controlled study.

BACKGROUND AND AIMS: The main limitation of plastic stents is the relatively short stent patency due to occlusion. We designed enteral extended biliary stents with lengths of 26 cm (EEBS-26 cm) and 30 cm (EEBS-30 cm) to prolong stent patency. This study aimed to compare patency among EEBS-26 cm, EEBS-30 cm, and conventional plastic biliary stent (CPBS). METHODS: A single-center prospective randomized controlled study was conducted. Eligible patients were randomized into the EEBS-26 cm, EEBS-30 cm, and CPBS groups, respectively. All patients were followed up every 3 months until stent occlusion, patient death, or at 12-month follow-up. The primary outcome was stent patency. The secondary outcomes included stent occlusion rate, patient survival, mortality, the rate of technical success, and adverse events. RESULTS: Totally 117 patients were randomized into the three groups. There were no significant differences among the three groups in technical success rate, hospital stay, mortality, patient survival, and adverse events (P = 1.000, 0.553, 0.965, 0.302, and 0.427, respectively). Median stent patency durations in the EEBS-26 cm, EEBS-30 cm, and CPBS groups were 156.0 (95% CI 81.6-230.4) days, 81.0 (95% CI 67.9-94.1) days, and 68.0 (95% CI 20.0-116.0) days, respectively (P = 0.002). The EEBS-26 cm group had longer stent patency compared with the CPBS (P = 0.007) and EEBS-30 cm (P < 0.001) groups. The EEBS-26 cm group had lower stent occlusion rates compared with the other groups at 6 months (48.1% vs. 90.5% vs. 82.8%, P = 0.001) and 9 months (75.0% vs. 100.0% vs. 92.9%, P = 0.022). CONCLUSION: EEBS-26 cm has prolonged stent patency and is safe and effective for the alleviation of unresectable extrahepatic malignant biliary obstruction.

Treatment of Femoropopliteal Lesions With the BioMimics 3D Vascular Stent System: Two-Year Results From the MIMICS-2 Trial.

PURPOSE: To report the safety and effectiveness outcomes through 2 years of the BioMimics 3D Vascular Stent System in the treatment of symptomatic patients with atherosclerotic femoropopliteal disease. MATERIALS AND METHODS: The tubular, nitinol BioMimics 3D stent, which was designed to impart a helical shape to the arterial segment, was implanted in 271 patients (mean age 68.4±9.5 years; 180 men) with de novo femoropopliteal lesions enrolled at 43 investigational sites [31 US (n=162), 6 German (n=78), and 6 Japanese (n=31)] in the prospective, single-arm MIMICS-2 investigational device exemption trial (ClinicalTrials.gov identifier NCT02400905) between June 2015 and October 2016. Mean lesion length was 81.2±38.4 mm, 30.0% of patients had total occlusions, and 45.9% had moderate to severe calcification. Primary safety and effectiveness endpoints were compared at 1 year with prespecified objective performance goals (OPGs) set by the VIVA Physicians organization. Outcomes through 2 years are reported. RESULTS: The primary effectiveness endpoint of 12-month primary stent patency was met by 182 of 249 patients (73.1%, 95% CI 67.3% to 78.2%), exceeding the OPG of 66%. The primary safety endpoint of 30-day freedom from major adverse events (MAEs) was met in 268 of 269 patients (99.6%, 95% CI 97.7% to 100%), exceeding the OPG of 88%. Kaplan-Meier estimates of freedom from loss of primary patency were 83.1% at 12 months and 70.2% at 24 months, freedom from MAEs estimates were 86.9% at 12 months and 79.2% at 24 months, and freedom from clinically-driven target lesion revascularization estimates were 88.0% at 12 months and 83.0% at 24 months. At 24 months, 88.2% of patients showed improvement of ≥1 Rutherford category; the ankle-brachial index was >0.9 for 64.4% vs 11.3% at baseline. There were no cases of stent fracture. CONCLUSION: Through 24 months, the BioMimics 3D Vascular Stent System provided safe and effective treatment for femoropopliteal lesions in patients with symptomatic peripheral artery disease.

Percutaneous stent placement for malignant hilar biliary obstruction: side-by-side versus stent-in-stent technique.

BACKGROUND: Currently, side-by-side (SBS) and stent-in-stent (SIS) are the two main techniques for stent deployment to treat hilar biliary obstructions. Previous studies comparing these two techniques are very limited, and thus, no consensus has been reached on which technique is better. The purpose of this study is to compare the clinical efficacy and safety of SBS and SIS deployment via a percutaneous approach for malignant hilar biliary obstruction. METHODS: From July 2012 to April 2019, 65 patients with malignant hilar biliary obstruction who underwent bilateral stenting using either the SBS or SIS techniques were included in this study. Among them, 27 patients underwent SIS stent insertion (SIS group), and the remaining 38 patients underwent SBS stent insertion (SBS group). Technical success, improvement of jaundice, complications, duration of stent patency, and overall survival were evaluated. RESULTS: Technical success was achieved in all patients in the two groups. The serum bilirubin level decreased more rapidly 1 week after the procedures in the SBS group than in the SIS group (P = 0.02). Although the total complication rate did not differ between the two groups, cholangitis was found to be more frequent in the SIS group (P = 0.04). The median stent patency was significantly longer in the SBS group (149 days) than in the SIS group (75 days; P = 0.02). The median overall survival did not significantly differ between the two groups (SBS vs. SIS, 155 days vs. 143 days; P > 0.05). CONCLUSIONS: Percutaneous transhepatic bilateral stenting using either the SBS or SIS technique is safe and effective in the management of malignant hilar biliary obstruction. However, SBS offers a quicker improvement of jaundice, a lower incidence of cholangitis after the procedure, and a longer stent patency period than SIS.

Dabigatran as an oral anticoagulant in patients with Budd-Chiari syndrome post-percutaneous endovascular intervention.

BACKGROUND AND AIM: Anticoagulants play an important role in the management of Budd-Chiari syndrome. There is a paucity of data on the efficacy and safety of direct-acting oral anticoagulants-dabigatran, among patients with Budd-Chiari syndrome. METHODS: In a retrospective analysis of prospectively maintained data, the stent patency rates, major bleeding episode, and a composite endpoint of major bleed and/or mortality rates were compared between Budd-Chiari syndrome patients treated with dabigatran (n = 36) or vitamin K antagonists (n = 62) following endovascular intervention. RESULTS: The baseline characteristics, including sites of block and types of interventions, were similar between the two groups. The mean duration of follow-up in the dabigatran and vitamin K antagonist groups was 10.5 ± 6.7 and 14.1 ± 6.9 months (P = 0.006), respectively. The endovascular stent patency rates were comparable between the dabigatran and vitamin K antagonist groups at 6 months (91% vs 96.5%) and 12 months (91% vs 93%), P = 0.296 (log-rank test), respectively. Major bleeding events were comparable between the dabigatran and vitamin K antagonist groups at 6 months (3.5% vs 2%) and 12 months (3.5% vs 6.5%), P = 0.895 (log-rank test), respectively. The composite endpoint of mortality and major bleed was comparable between dabigatran and vitamin K antagonists at 6 months (4% vs 5%) and 12 months (4% vs 8%), P = 0.875 (log-rank test), respectively. CONCLUSIONS: Dabigatran, as compared with vitamin K antagonists, is associated with similar stent patency rates and complications among patients with Budd-Chiari syndrome post-endovascular intervention.

Serum Sirolimus Levels After Implantation of Third Generation Drug Eluting Cobalt Chromium Coronary Stent in Ductus Arteriosus in Neonates with Duct-Dependent Pulmonary Circulation.

Ductal stenting (DS) palliates duct-dependent lesions using coronary stents. Sirolimus-eluting stents have replaced bare-metal stents in coronary interventions. Concerns exist about sirolimus levels in neonates. Therapeutic immunosuppressive sirolimus level is 5-15 ng/ml. After neonatal DS, drug levels were assessed at 24 h, 7 days and monthly thereafter till they were undetectable. Clinical course, ductal patency till their final corrective surgery was analyzed. The exact quantity of sirolimus in each stent was known. Twelve neonates with median age of 5.5 days received sirolimus-eluting stents, one stent in nine and two in the rest. The lesions were pulmonary atresia intact ventricular septum(PAIVS) in four, univentricular lesions with pulmonary atresia in four, biventricular lesions with pulmonary atresia in three and right ventricular rhabdomyoma in one neonate. If single stents up to 22 mm length, 24-h drug levels were less than 5 ng/ml. Even though 24-h levels were above 5 ng/ml in patients with single longer stent or two stents, it reduced to very low levels by seventh day. Two hospital deaths included rhabdomyoma with complete heart block and post-valvotomy cardiac failure for PAIVS. Stent patency after valvotomy for PAIVS exceeded three years. Patency was retained for 8-27 months till their elective corrective surgery in others. Sirolimus levels were acceptable at 24 h in all neonates receiving single stent under 22 mm length. In patients needing two stents, drug levels were in immunosuppressive range at 24 h but reduced rapidly within 7 days. The palliation provided by sirolimus-eluting DS was sufficiently long to provide clinical benefit.

Folfirinox chemotherapy prolongs stent patency in patients with malignant biliary obstruction due to unresectable pancreatic cancer.

BACKGROUND: Stent insertion for biliary decompression to relieve jaundice and subsequent biliary infection is necessary for patients with biliary obstruction caused by pancreatic cancer, and it is important to keep the stent patent as long as possible. However, few studies have compared stent patency in terms of chemotherapy in patients with pancreatic cancer. This study aimed to evaluate the differences in stent patency in terms of recently evolving chemotherapy. METHODS: Between January 2015 and May 2017, 161 patients with pancreatic cancer who had undergone biliary stent insertion with a metal stent were retrospectively analyzed. The relationship between chemotherapy and stent patency was assessed. Additionally, overall survival according to the treatment, risk factors for stent patency, and long-term adverse events were evaluated. RESULTS: Median stent patency was 42 days for patients with the best supportive care and 217 days for patients with chemotherapy (conventional gemcitabine-based chemotherapy and folfirinox) (P < 0.001). Furthermore, the folfirinox group showed the longest median stent patency and overall survival, with 283 days and 466 days, respectively (P < 0.001) despite higher adverse events rate. Patients who underwent folfirinox chemotherapy after stent insertion had better stent patency in multivariate analysis (HR = 0.26; 95% CI: 0.12-0.60; P = 0.001). CONCLUSIONS: Compared with patients who received best supportive care only, patients who underwent chemotherapy after stent insertion had better stent patency. More prolonged stent patency can be expected for patients with folfirinox than conventional gemcitabine-based chemotherapy.

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

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

Metallic Stent Expansion Rate at Day One Predicts Stent Patency in Patients with Gastric Outlet Obstruction.

BACKGROUND AND AIMS: Self-expandable metallic stent insertion has been a mainstream treatment for relieving the obstructive symptoms of malignant gastric outlet obstruction (MGOO), a late-stage complication of gastrointestinal malignancies. This study aims to investigate the predictive value of stent expansion rates in clinical outcomes in patients with MGOO. METHODS: Eighty-seven patients with inoperable MGOO receiving metallic stents were reviewed retrospectively from April 2010 to December 2014. Clinical outcomes, predictors of stent patency, and survival were analyzed. RESULTS: The technical and clinical success rates were 100 and 94.3%, respectively. The median stent patency time was 114 days (range 13-570 days). The median survival time was 133 days (range 13-1145 days). Stent dysfunctions occurred in 28 patients (32.2%), with restenosis accounting for the majority (82%). The stent expansion rate ≥75% at Day 1 predicted the stent patency [hazard ratio (HR) 0.12, P = 0.04]. However, it did not correlate with survival. Non-gastric cancer origins (HR 2.41, P = 0.002) and peritoneal carcinomatosis (HR 2.54, P = 0.001) correlated with poor survival. However, post-stent chemotherapy (HR 0.55, P = 0.03) was related to better outcome. The comparison of clinical outcomes of first and second stent insertions showed no significant difference in the stent expansion rate either at Day 0 and Day 1 (P = 0.97 and P = 0.57). CONCLUSIONS: Self-expandable metallic stent insertion is a safe and effective treatment for relieving the obstructive symptoms. The stent expansion rate ≥75% at Day 1 is a novel stent-related predictor of stent patency.

Reintervention for occluded metal stent in malignant bile duct obstruction: A prospective randomized trial comparing covered and uncovered metal stent.

BACKGROUND AND AIM: No prospective data are available on comparing covered and uncovered self-expandable metal stent (SEMS) for reintervention of occluded uncovered metal stents during endoscopic retrograde cholangiopancreatography in patients with malignant distal biliary obstruction. METHODS: From June 2010 to November 2014, 43 patients with inoperable distal biliary obstruction of a previously placed uncovered SEMS were enrolled from three centers in Korea and randomly assigned to covered (n = 22) or uncovered SEMS group (n = 21). The primary outcome was overall stent patency. Secondary outcome was time-to-stent occlusion, patient survival, cause of stent occlusion, and adverse events. RESULTS: Overall median patency of secondary stent was 112.0 days. Median stent patency of covered and uncovered SEMS was 112.0 and 181.0 days, respectively, (P = 0.373). There was a tendency towards a longer time-to-stent occlusion in uncovered SEMS group (median: 112.0 vs 181.0 days). However, it did not reach statistical significance (P = 0.214). Most common causes of occlusion were stent clogging (36.4%) and tumor ingrowth (33.3%) in covered and uncovered SEMS groups, respectively. There was no significant difference in median survival between the groups (median: 308 vs 300 days; P = 0.325). Acute cholangitis occurred in four patients (three in covered vs one in uncovered SEMS group, P = 0.607). CONCLUSIONS: In this exploratory trial, there were no statistically significant differences in stent patency, time-to-stent occlusion, patient survival, and complication rates between covered and uncovered SEMS groups. Larger confirmatory multicenter trial is needed for the clear conclusion (ClinicalTrials.gov: NCT01315522).

Long-term outcomes of endoscopic ultrasound-guided hepaticogastrostomy in patients with malignant biliary obstruction.

BACKGROUND: Hepaticogastrostomy drainage through endoscopic ultrasound (EUS-HGS) has emerged in the 2010s as a new technique for biliary decompression in cases of endoscopic retrograde cholangiopancreatography (ERCP) failure for malignant biliary obstruction (MBO). Substantial technical and procedural progress in performing EUS-HGS has been achieved, allowing high technical and clinical success and an acceptable risk of adverse events in studies mainly focusing on short-term outcomes. However, the long-term effects of EUS-HGS and the risk of recurrent biliary obstruction (RBO) have not been fully evaluated. OBJECTIVES: To evaluate the long-term effects of EUS-HGS and the risk of RBO. METHODS: Data from 211 patients undergoing technically successful EUS-HGS in three academic centers were retrospectively collected. Clinical success, adverse events, RBO, and reinterventions were evaluated. RESULTS: In total, 198 patients underwent technically successful EUS-HGS for MBO. The median overall survival was 144 days [108, 2011] after the procedure. Mean patient age was 69.39 (12.91) years. The cause of MBO was pancreatic cancer (n = 98, 49.5%) followed by cholangiocarcinoma (n = 29, 14.6%). The location of MBO was distal in 27.6% of cases and proximal in 68.4%. Adverse events were observed during the follow-up in 65 patients (33%). On multivariate analysis, the use of partially covered self-expandable metal stents (PCSEMS) was associated with a lower risk of RBO (HR = 0.47 [0.24-0.95], p = 0.034). Additionally, patients with distal stenoses had a trend toward better stent patency (HR = 0.06[0-0.77], p = 0.031). RBO developed in 38 cases (19.1%) mainly due tumor ingrowth (36.8%) with a high success rate of endoscopic management. CONCLUSIONS: While RBO occurred in a notable proportion of patients, the primary cause of mortality was progression of the underlying malignancy rather than stent dysfunction. The efficiency of stents, particularly PCSEMS, and the high success rate of endoscopic management for RBO underscore the effectiveness and reliability of these treatments in managing biliary complications.

Anticoagulation plus antiplatelet therapy versus anticoagulation alone following iliac vein stent implantation in acute and subacute deep vein thrombosis: A multicenter study with propensity score matching.

BACKGROUND: Iliac vein stenting is an effective treatment for iliac venous stenosis after percutaneous mechanical thrombectomy. Nevertheless, while some researchers have investigated medical therapy following iliac vein stenting, no consensus has been reached to date. OBJECTIVES: To evaluate the effectiveness and safety of anticoagulation plus antiplatelet therapy following iliac vein stent implantation in patients with acute and subacute iliofemoral deep vein thrombosis (DVT). MATERIALS AND METHODS: This retrospective study comprised 234 patients: 167 patients in Group 1 with a mean age of 64.3 ± 13.5 years received anticoagulants alone, and 67 patients in Group 2 with a mean age of 60.7 ± 15.4 years received anticoagulation plus antiplatelet therapy. All patients received technically successful percutaneous pharmacomechanical thrombectomy and iliac vein stent implantation, and 61 patients underwent additional catheter-directed thrombolysis. The two groups exhibited comparable demographics, comorbidities, DVT burdens, and procedural details. Through propensity score matching (PSM) analysis, 62 pairs of patients from Group 1 and Group 2 were matched. RESULTS: During a follow-up period of 33.7 ± 16.5 months, the cumulative primary patency rates were 95.1 %, 89.7 % and 88.3 % at one, three and five years in Group 1 compared to 98.8 %, 98.5 % and 98.5 % in Group 2 for the entire cohort (p = 0.042); in the PSM analysis, the rates were 91.9 %, 87.3 % and 87.3 % at one, three and five years in Group 1 versus 98.4 % at one, three and five years in Group 2 (p = 0.039). The cumulative bleeding-free rate was 98.2 % at one, three and five years in Group 1 versus 95.5 %, 93.8 % and 93.8 % at one, three and five years in Group 2 for the entire cohort (p = 0.089), and it was 98.4 % at one, three and five years in Group 1 versus 95.2 %, 93.3 % and 93.3 % (p = 0.156) at one, three and five years in Group 2 in the PSM analysis. CONCLUSION: Anticoagulation plus antiplatelet therapy significantly improved stent patency, with a non-significant increase in the bleeding rate.

Stenting across inferior vena cava filters can be a safe and effective alternative to complex retrieval.

OBJECTIVE: Venous stenting for acute and chronic venous disease has been increasingly used as more evidence has accumulated on the efficacy and durability of these interventions for symptomatic patients. Inferior vena cava (IVC) filters that could have been present for years will often be implicated in the obstructive pathology and removal can be challenging. The purpose of the present study was to evaluate whether stenting across an indwelling IVC filter is a safe and effective alternative to removal. METHODS: Consecutive patients who had undergone iliocaval stenting at our institution from 2007 to 2020 were identified and divided into groups stratified by the presence of an IVC filter. The operative notes, venography findings, and the electronic health records were queried to obtain the operative details, patient characteristics, postoperative outcomes, stent patency, and survival outcomes. The primary end point was iliocaval stent patency. The patients were divided into two groups according to the presence of an IVC filter with or without overstenting. We used the χ2 test and survival analysis as appropriate. RESULTS: A total of 224 consecutive patients were identified, of whom 71 were found to have undergone iliocaval stenting (age, 48 ± 18 years; 47.9% male; body mass index, 31 ± 9 kg/m2). Of the 71 patients, 15 had had stents placed across an indwelling IVC filter (overstented group) and 56 had not had an IVC filter present (non-overstented group). No differences were found in presentation between the overstented group (acute occlusion, 4 of 15 [26.7%]; chronic occlusion, 8 of 15 [53.3%]; and nonocclusive lesions, 3 of 15 [20%]) and the non-overstented group (acute occlusion, 29 of 56 [52%]; chronic occlusion, 18 of 56 [32%]; nonocclusive lesions, 9 of 56 [16%]; P = .2). Comparisons between the two groups revealed no differences in the baseline characteristics except for age (overstented, 57 ± 15 years; non-overstented, 46 ± 18 years; P = 0.03), preoperative anticoagulation therapy (overstented, 66.6%; non-overstented, 26.9%; P = .01), and bilateral leg symptoms (overstented, 86.7%; non-overstented, 23.2%; P < .001). Primary patency at 30 months was 85.6% in the overstented group and 86.1% in the non-overstented group (P = .78). At follow-up, no adverse events related to filter crushing were reported, and no differences were found in 30-month survival. CONCLUSIONS: In our single-center, retrospective study of iliocaval stenting, patients who had undergone overstenting across an indwelling IVC filter had had patency rates similar to those whose stents had been placed with no IVC filter in place. Thus, complex IVC filter removal, when not possible or when the risk of operative complications is too high, can be forgone in favor of stenting across the IVC filter, with no implications on midterm patency or adverse events.

Safety and efficacy of self-expandable metallic stent combined with 125I brachytherapy for the treatment of malignant obstructive jaundice.

BACKGROUND: Several previous studies demonstrated that the combination of self-expandable metallic stents (SEMS) and 125I seed implantation might prolong stent patency and obtain survival benefits for malignant obstructive jaundice (MOJ) patients. However, these studies rarely mentioned a comparison between CT-guided intratumoral 125I seed implantation and intraluminal 125I seed strand insertion combined with stenting for the management of MOJ. This study aimed to further evaluate the safety and efficacy of SEMS combined with 125I brachytherapy in the management of unresectable MOJ. METHODS: Fifty-nine patients with unresectable MOJ were retrospectively included from March 2018 to June 2021. The main therapeutic outcomes were evaluated in terms of stent patency, and overall survival. Cumulative stent patency and overall survival rates were calculated by Kaplan-Meier survival analysis. Both clinical and treatment factors associated with survival were analyzed. RESULTS: Technical success was achieved in all patients. The clinical success rate was 94% (32/34) in the seeds group and 92% (23/25) in the control group, no significant difference was found (p =1.000). The median duration of stent patency was significantly longer in the 125I brachytherapy group compared with the control group (289 days vs. 88 days, respectively, p =0.001). The 125I brachytherapy group demonstrated a significantly better median overall survival rate than the control group (221 days vs. 78 days, respectively, p =0.001). In multivariate analysis, stents with 125I brachytherapy (p =0.004) was a significant favorable prognostic factor that affected patient survival. No significant difference was observed between CT-guided 125I seed implantation and 125I seed strand insertion in stent patency (p =0.268), and overall survival (p =0.483). CONCLUSION: SEMS combined with 125I brachytherapy is safe and effective for treating MOJ. 125I brachytherapy may help to maintain stent patency and prolong overall survival. There was no significant difference between CT-guided 125I seed implantation with SEMS and 125I seed strand insertion with SEMS in stent patency and overall survival.

Outcomes of dedicated iliac venous stents during pregnancy and postpartum.

OBJECTIVE: The aim of this study was to assess the performance of dedicated iliac venous stents during subsequent pregnancy and postpartum, including stent patency and stent integrity, as well as incidence of venous thromboembolism and bleeding complications. METHODS: This study included retrospective analysis of prospectively collected data of patients attending a private vascular practice. Women of child-bearing age who had received dedicated iliac venous stents were included in a surveillance program and then, for any subsequent pregnancies, followed the same pregnancy care protocol. This included an antithrombotic regime of 100 mg aspirin daily until gestation week 36, and subcutaneous enoxaparin at a dose dependent on risk of thrombosis: low-risk patients, those stented for non-thrombotic iliac vein lesion, received a prophylactic dose of 40 mg/day from the third trimester; high-risk patients, those stented for thrombotic indication, received a therapeutic dose of 1.5 mg/kg/day from the first trimester. All women underwent follow-up with duplex ultrasound assessment of stent patency during pregnancy and at 6 weeks postpartum. RESULTS: Data was analyzed for a total of 10 women and 13 post-stent pregnancies. Stents were placed for non-thrombotic iliac vein lesions in seven patients, and for post-thrombotic stenoses in three patients. All stents were dedicated venous stents, and four crossed the inguinal ligament. All stents remained patent during pregnancy, at 6 weeks postpartum, and latest follow-up (median time post-stent, 60 months). There were no cases of deep vein thrombosis or pulmonary embolism, and no bleeding complications. There was only one reintervention case due to in-stent thrombus, and one case of asymptomatic stent compression. CONCLUSIONS: Dedicated venous stents performed well through pregnancy and post-partum. A protocol including the use of low dose antiplatelets in combination with anticoagulation at either a prophylactic or therapeutic dose depending on the patient's risk profile appears safe and effective.

Impact of endobiliary radiofrequency ablation on survival of patients with unresectable cholangiocarcinoma: a narrative review.

Cholangiocarcinoma (CCA) is a rare cancer originating from the biliary epithelium and accounts for about 3% of all gastrointestinal malignancies. Unfortunately, the majority of patients are not eligible for surgical resection at the time of diagnosis, because of the locally advanced stage or metastatic disease. The overall survival time of unresectable CCA is generally less than 1 year, despite current chemotherapy regimens. Biliary drainage is often required as a palliative treatment for patients with unresectable CCA. Recurrent jaundice and cholangitis tend to occur because of reobstruction of the biliary stents. This not only jeopardizes the efficacy of chemotherapy, but also causes significant morbidity and mortality. Effective control of tumor growth is crucial for prolonging stent patency and consequently patient survival. Recently, endobiliary radiofrequency ablation (ERFA) has been experimented as a treatment modality to reduce tumor mass, and delay tumor growth, extending stent patency. Ablation is accomplished by means of high-frequency alternating current which is released from the active electrode of an endobiliary probe placed in a biliary stricture. It has been shown that tumor necrosis releases intracellular particles which are highly immunogenic and activate antigen-presenting cells, enhancing local immunity directed against the tumor. This immunogenic response could potentially enhance tumor suppression and be responsible for improved survival of patients with unresectable CCA who undergo ERFA. Several studies have demonstrated that ERFA is associated with an increased median survival of approximately 6 months in patients with unresectable CCA. Furthermore, recent data support the hypothesis that ERFA could ameliorate the efficacy of chemotherapy administered to patients with unresectable CCA, without increasing the risk of complications. This narrative review discusses the results of the studies published in recent years and focuses on the impact that ERFA could have on overall survival of patients with unresectable cholangiocarcinoma.

Is endoscopic radiofrequency ablation plus stent placement superior to stent placement alone for the treatment of malignant biliary obstruction? A systematic review and meta-analysis.

OBJECTIVE: Malignant biliary obstruction (MBO) is a rare disease with a poor prognosis. Recent studies have shown that endoscopic radiofrequency ablation (ERFA) may improve survival. We conducted a systematic review and meta-analysis of the efficacy of ERFA in combination with biliary stent placement for the treatment of MBO. METHODS: The study was registered in INPLASY (number 202340096). The PubMed, Cochrane Library, Web of Science, and Embase databases were searched from inception to April 2023. We selected studies comparing the efficacy of ERFA plus stent placement with stent placement alone. The primary outcomes were pooled hazard ratios (HRs) for overall survival and stent patency; the secondary outcomes were the odds ratios (ORs) for adverse events. RESULTS: Eleven studies (four randomized controlled trials and seven observational studies) were included in the meta-analysis. Pooled analysis showed a difference in survival time between the two groups (HR 0.65, 95% confidence interval [CI] 0.58-0.73, I2 = 40%). However, there were no differences in the duration of stent patency or the incidence of adverse events (HR 1.04, 95% CI 0.84-1.29, I2 = 46%; OR 1.41, 95% CI 1.02-1.96, I2 = 29%). CONCLUSIONS: ERFA has a significant survival benefit for MBO, but does not increase the risk of adverse events.