Unilateral drainage and chemotherapy prolong the patency of a plastic stent placed above the sphincter of Oddi in patients with malignant hilar biliary obstruction.

Objectives: To evaluate the results of inside stent therapy for unresectable malignant hilar biliary obstruction and identify factors related to stent patency duration. Methods: Of 44 patients who underwent initial inside-stent placement above the sphincter of Oddi from April 2017 to December 2022, 42 with the resolution of jaundice (clinical success rate, 95.5%) were retrospectively analyzed. Univariate and multivariate logistic regression analysis identified factors associated with stent patency duration. Results: Univariate analysis revealed significant differences in the drainage method (406 days for unilateral drainage vs. 305 days for bilateral drainage of the right and left liver lobes, p = 0.022) with or without chemotherapy (406 days with vs. 154 days without, p = 0.038). Multivariate analysis (Cox proportional hazards analysis) revealed similar results, with unilateral drainage (p = 0.031) and chemotherapy (p = 0.048) identified as independent factors associated with prolonged stent patency. Early adverse events were observed in two patients (4.8%; one cholangitis, one pancreatitis). Conclusions: Inside-stent therapy was safely performed in patients with malignant hilar biliary obstruction. Simple unilateral drainage and chemotherapy may prolong stent patency.

Risk factors for biliary tract events during elective cholecystectomy waiting time after endoscopic retrograde cholangiopancreatography for choledocholithiasis.

Objectives: Endoscopic lithotripsy and elective cholecystectomy, followed by endoscopic retrograde cholangiopancreatography, are the first-line treatments for patients with common bile duct (CBD) stones (CBDS) and gallstones. However, this approach entails acute cholecystitis and recurrent cholangitis risk while patients await surgery. We aimed to identify acute cholecystitis and cholangitis risk factors during the waiting time for elective cholecystectomy. Methods: This study comprised 151 patients with CBDS combined with gallstones who underwent cholecystectomy within 90 days of the first endoscopic retrograde cholangiopancreatography at two tertiary care centers between January 2019 and October 2021. Results: The incidence of biliary tract events (acute cholecystitis, acute cholangitis, or any complications requiring unplanned cholangiopancreatography) was 28% (43 cases). In univariate and multivariate analyses, plastic stent placement as a bridge to surgery for the first treatment of CBDS was an independent risk factor for biliary tract events during the waiting time for surgery (odds ratio 4.25, p = 0.002). A subgroup analysis among those with plastic stent placement revealed a CBD diameter of ≤ 10 mm as an independent risk factor for acute cholecystitis (odds ratio 4.32; p = 0.027); a CBD diameter ≥ 11 mm was an independent risk factor for acute cholangitis and unplanned re-endoscopic retrograde cholangiopancreatography (odds ratio 5.66; p = 0.01). Conclusions: Plastic stent placement for CBDS before elective cholecystectomy increases the risk of acute cholecystitis or acute cholangitis during the waiting time for elective cholecystectomy.

Endoscopic ultrasound-guided choledochoduodenostomy versus hepaticogastrostomy combined with gastroenterostomy in malignant double obstruction (CABRIOLET_Pro): A prospective comparative study.

Objectives: Malignant double obstruction, defined as the simultaneous presence of biliary and gastric outlet obstruction, represents a challenging clinical scenario. Previous retrospective experiences have demonstrated shorter dysfunction-free survival (DyFS) of endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) versus EUS-hepaticogastrostomy (EUS-HGS) in this setting, but no prospective evidence is available. Methods: Twenty consecutive patients with malignant double obstruction, treated with EUS-gastroenterostomy (and EUS-guided biliary drainage, following a previously failed ERCP, were enrolled in a prospective observational study (ClinicalTrials.gov NCT04813055) comparing EUS-CDS versus EUS-HGS. Efficacy and safety were evaluated, with Biliary Dysfunctions as the primary outcome and DyFS using Kaplan-Meier estimates as a primary measure. Results: Twenty patients (75% with pancreatic cancer, 50% with metastatic disease) with EUS-gastroenterostomy were included (seven EUS-CDS and 13 EUS-HGS). No significant difference was detected at baseline. Technical success was 100% in both groups. EUS-CDS compared to EUS-HGS showed similar clinical success (100% vs. 92.3%, p = 0.5), a higher rate of post-procedural adverse events (42.9% vs. 7.7%, p = 0.067, mostly related to severe/fatal cholangitis in the EUS-CDS group) and a higher rate of biliary dysfunctions during follow-up (71.4% vs. 16.7%, p = 0.002).DyFS was significantly shorter in the EUS-CDS group (39 [15-62] vs. 268 [192-344] days, p = 0.0023), with a 30-days DyFS probability of 57.1% vs. 100% (hazard ratio = 7.8 [1.4-44.2]). Conclusions: In this prospective comparison of patients with malignant double obstruction undergoing EUS-gastroenterostomy, treating jaundice with EUS-CDS versus EUS-HGS resulted in a reduced probability of survival without biliary events and an increased risk of biliary dysfunctions (number needed to harm = 1.8), with detection of severe/fatal cholangitis.

Efficacy and safety of a novel polytetrafluoroethylene-coated self-expandable metal stent for distal malignant biliary obstruction.

Background: Stent migration and sludge formation remain significant problems associated with covered self-expandable metal stents (CSEMSs). The EGIS biliary stent fully covered flare type (EGIS biliary stent), a new type of polytetrafluoroethylene-coated self-expandable metal stent with low axial force and an anti-migration system, was developed to overcome these disadvantages. We conducted this study to evaluate the efficacy and safety of this stent in comparison with conventional CSEMS (c-CSEMS). Methods: We retrospectively analyzed consecutive patients with unresectable pancreatic cancer who received initial CSEMS for distal malignant biliary obstruction. The primary outcome was time to recurrent biliary obstruction (RBO). Secondary outcomes included technical success rate, functional success rate, stent-related adverse events, causes of RBO, and re-intervention. Results: A total of 40 patients were included (EGIS group: 20; c-CSEMS group: 20). The technical and functional success rates were similar between the two groups. Stent-related adverse event rates (20% vs. 15%, p > 0.99) and overall RBO rates (56% vs. 50%, p > 0.99) were not significantly different between the two groups. Stent migration was the most common cause of RBO in the EGIS group, while stent occlusion was in the c-CSEMS group. The median time to RBO (102 vs. 434 days, p = 0.10) was not significantly different between the two groups. Endoscopic transpapillary re-intervention was successful in most patients in both groups. Conclusions: The EGIS biliary stent was not associated with a longer time to RBO compared to c-CSEMS. Further improvements, especially against stent migration, are needed to improve its efficacy.

Efficacy and safety of uncovered self-expandable metal stents for distal malignant biliary obstruction in unresectable non-pancreatic cancer.

Objectives: The efficacy of uncovered self-expandable metal stents (UCSEMS) versus fully covered self-expandable metal stents for distal malignant biliary obstruction remains controversial. Additionally, the heterogeneity of the disease conditions has been indicated in previous studies because pancreatic and non-pancreatic cancers have different characteristics in clinical course. Therefore, the etiology of biliary obstruction necessitates investigations stratified by primary disease. This study aimed to evaluate the outcomes of UCSEMS, specifically for non-pancreatic cancer-induced distal malignant biliary obstruction. Methods: We conducted a single-center retrospective review to evaluate the time to recurrent biliary obstruction and frequency of adverse events (AEs) in patients receiving UCSEMS for unresectable non-pancreatic cancer-induced malignant biliary obstruction. Results: Overall, 32 patients were enrolled in the study between January 2016 and December 2023. The median time to recurrent biliary obstruction was 140 days. AE rates were low at 3.1% for both pancreatitis and cholecystitis, suggesting a potential benefit of UCSEMS in reducing post-procedural AEs. Conclusion: UCSEMS may reduce the risk of post-procedural AEs and should be considered in patients at high risk of post-endoscopic retrograde cholangiopancreatography pancreatitis. However, the patency period may be shorter, necessitating future comparative research with fully covered self-expandable metal stents to determine the optimal stent choice.

Outcomes of multi-hole self-expandable metal stents versus fully covered self-expandable metal stents for malignant distal biliary obstruction in unresectable pancreatic cancer.

Objectives: The multi-hole self-expandable metal stent (MHSEMS) is a novel SEMS with multiple small side holes on the covering membrane to prevent stent migration while minimizing tumor ingrowth. This study aimed to evaluate the clinical outcomes of MHSEMS in comparison with conventional covered SEMS (c-CMS). Methods: Consecutive patients with unresectable pancreatic cancer who underwent initial SEMS placement (MHSEMS or c-CMS) for malignant distal biliary obstruction were analyzed. Technical success, clinical success, causes of recurrent biliary obstruction (RBO), non-RBO adverse events, time to RBO (TRBO), and endoscopic reintervention were compared between groups. Results: A total of 65 patients were included (MHSEMS: 27, c-CMS: 38). The technical success, clinical success, and non-RBO adverse event rates were similar between groups. Although stent migration was less frequently observed in the MHSEMS group (0% vs. 17.6%, p = 0.032), overall RBO rates were similar between groups (53.8% vs. 55.9%, p > 0.99). The most common cause of RBO within 14 days in the MHSEMS group was non-occlusion cholangitis. Median TRBO was significantly shorter in the MHSEMS group (101 vs. 227 days, p = 0.030) and MHSEMS was an independent predictor for shorter TRBO in multivariate analysis (hazard ratio, 2.27; 95% confidence interval, 1.06-4.86; p = 0.034). Outcomes after endoscopic interventio were not significantly different between groups. Stent removal was successful in all attempted cases in both groups. Conclusions: MHSEMS was associated with a significantly shorter TRBO compared to c-CMS. Further modifications of the present MHSEMS may be needed.

Safety and efficacy of thermo-expandable metallic stent in ureteral stricture following gynecological malignancy surgery and radiotherapy: a single center experience with 33 cases.

BACKGROUND: The effectiveness of metallic stents in treating ureteral strictures following surgery and radiotherapy for gynecological tumors is currently uncertain. We aimed to investigate the efficacy and safety of thermo-expandable metallic stent (Memokath) in the treatment of ureteral stricture after radiotherapy for gynecological tumors. METHODS: In this descriptive cross-sectional study, 27 patients with ureteral stricture were treated with Memokath stent after gynecological tumor radiotherapy with or without chemotherapy that was admitted to our hospital from August 2021 to August 2023. Clinical data on efficacy, safety, and complications during stent insertion and indwelling were analyzed. RESULTS: The successful insertion of thirty-three stents in twenty-seven patients studied. The stenosis length was 10.14 ± 6.76 cm, and the hospitalization was 4.43 ± 1.83 days. One patient has died from the primary disease carrying a patency stent. The Kaplan-Meier graph showed that the cumilative patency rate of patients with thermo-expandable metallic stent were 92.4% (SD = 5.2%) in eight months, 77.4% (9.1%) in 12 months and 67.7% (SD = 12%) in 29 months, while the cumilative survival rate was 87.5% (SD = 11.5%) in 29 months. The stent patency was 81.48% and later complications of stent indwelling were 5/27, including refractory urinary tract infection (UTI) in three cases, stent migration, and stent intolerance respectively. The creatinine levels, hydronephrosis degree, and glomerular filtration rate improved after the operation, and the first two indicators were statistically significant. CONCLUSION: Memokath stent is a safe and effective treatment for ureteral stricture after surgery and radiotherapy with or without chemotherapy for gynecological tumors.

Self-expanding metal stent for relieving the stricture after endoscopic injection for esophageal varices.

BACKGROUND: Esophageal stricture is one of the complications after esophageal varices sclerotherapy injection (ESI), and the incidence rate is between 2%-10%. AIM: To explore the efficacy of self-expanding metal stent (SEMS) for the stricture after endoscopic injection with cyanoacrylate (CYA) and sclerotherapy for esophageal varices. METHODS: We retrospectively analyzed the efficacy of SEMS to improve the stricture after endoscopic injection with CYA and sclerotherapy for esophageal varices in 4 patients from February 2023 to June 2023. RESULTS: The strictures were improved in four patients after stenting. The stent was removed after two weeks because of chest pain with embedding into esophageal mucosa in one patient. The stent was removed after one month, however, the stent was reinserted because of the strictures happening again in two patients. The stent was removed after three months, however, the stent was reinserted because of the strictures happening again in one patient. The stent embedded into esophageal mucosa in three patients. There were 3 patients suffered reflux esophagitis, and the acid reflux was relieved by taking hydrotalcite. There was no other complication of esophageal perforation, bleeding from varices or infection. CONCLUSION: SEMS may relieve the stricture which happened after endoscopic injection with CYA and sclerotherapy for esophageal varices. However, when we should remove the stent still needs to be explored.

Bifurcated Endografts for the Treatment of Aortoiliac Disease a Systematic Review and Individual Patient Data (IPD) Meta-Analysis.

BACKGROUND: This review aimed to assess the efficacy and safety of bifurcated endografts in the treatment of aortoiliac disease (AOID). METHODS: A systematic search on PubMed, Scopus, and Web of Science was performed. The primary endpoint was primary patency, whereas secondary endpoints included reintervention, technical, clinical success, and overall postoperative complications. RESULTS: Ten studies with a total of 365 patients were included in this review. Most included studies used the AFX unibody endograft, one study the Excluder endograft, and one the Powerlink endograft. The majority of included patients displayed TransAtlantic InterSociety Consensus (TASC) D aortoiliac lesions (56.1% 205/365). The pooled primary patency estimates at 12, 24, and 36 months were 93.93% (95% confidence interval [CI]: 87.7-100), 91.46% (95% CI: 84.6-98.8), and 90.25% (95% CI: 82.6-98.6), respectively. The mean primary patency time was 85.74 months (95% CI: 71.99-86.88). The pooled freedom from reintervention estimates at 12, 24, and 36 months were 91.94% (95% CI: 81.4-100), 91.03% (95% CI: 79.8-100), and 91.03% (95% CI: 79.8-100), respectively. The pooled estimates of major complications (rupture, graft thrombosis, amputation) were 11.12% (95% CI, 0.05%-3.03%), 3.76% (0.32%-9.45%), and 0.38% (0%-2.59%), whereas the pooled estimates for minor complications (hematoma, groin infection, dissection) and overall mortality were 5.27% (95% CI, 1.11%-11.38%), 6.93% (95% CI, 2.94%-12.16%), 2.19% (95% CI, 0.06%-6.14%), and1.57% (95% CI, 0.13-3.97), respectively. Technical and clinical success estimates were 99.92% (95% CI: 98.86%-100%) and 99.47% (95% CI: 94.92%-100%), respectively. CONCLUSION: The application of bifurcated endografts may present a safe and viable option in the treatment of AOID, with preliminary results indicating promising primary patency outcomes. However, the definitive assessment of their efficacy and safety will be better determined through long-term follow-up studies and high-quality randomized controlled trials, which are essential to substantiate these initial findings. CLINICAL IMPACT: Bifurcated endograft application may be a safe and viable alternative for high-risk patients with complex AOID TASC C and D lesions with encouraging primary patency outcomes potentially comparable to those of open surgery. Non-negligible postoperative complication rates were also noted. High-quality randomized controlled trials and studies comparing CERAB, kissing stenting, and the use bifurcated endografts for the treatment of AOID is necessary to draw more definite conclusions.

Tailoring silk-based covering material with matched mechanical properties for vascular tissue engineering.

Vascular covered stents play a significant therapeutic role in cardiovascular diseases. However, the poor compliance and biological inertness of commercial materials cause post-implantation complications. Silk fibroin (SF), as a biomaterial, possesses satisfactory hemocompatibility and tissue compatibility. In this study, we developed a silk film for use in covered stents by employing a layer-by-layer self-assembly strategy with regenerated SF on silk braiding fabric. We investigated the effects on the mechanical properties of the silk films in detail, which were closely correlated with fabric parameters and layer-by-layer self-assembly. The results showed that there was a significant relationship between these factors and both the compliance and mechanical strength. The 1 × 2/90°/100/SF6 film exhibited excellent mechanical properties. Notably, compliance reached 2.6%/100 mmHg, matching that of the human saphenous vein. Thus, this strategy shows promise in developing a novel covered stent, with biocompatible and comprehensive mechanical properties, and significant potential for clinical applications.

Is double-J stent mandatory in complete supine percutaneous nephrolithotomy for adult patients with staghorn renal stones?

BACKGROUND: It is controversial whether double-J (DJ) stent insertion is necessary in tubeless percutaneous nephrolithotomy (PCNL) for patients with staghorn stones. We compared the outcomes of using ureteral catheters and double-J stents in tubeless complete supine PCNL (csPCNL) of staghorn stones. METHODS: In this analytical cross-sectional study, from May 2008 to August 2022, 123 patients who underwent tubeless csPCNL were assessed. Patients were divided into two groups by either tubeless csPCNL with DJ stent (Group I; n = 23) or totally tubeless just with perioperative ureteral stent (Group II; n = 100). Demographic characteristics, stone-related factors, perioperative and postoperative parameters were compared in groups. RESULTS: Baseline characteristics were comparable in groups. The operative time in group I was significantly longer than group II (68.26 vs. 55.25 min, P = 0.05). However, the duration of hospitalization in Group I was shorter than the other group (1.81 vs. 2.37 days, P = 0.03). Stone free rate was notably higher in Group I (90.5% vs. 79.8.0%) with no statistically significant difference. No significant differences were found in major complications. Patients in Group II had a significantly shorter time to return to normal life (6.48 vs. 7.91 day; P = 0.043). Multivariable linear regression showed the preoperative creatinine level and stone size can affect the operative time (P = 0.02). In addition, stone number and underlying disease can affect the length of hospital stay (P = 0.007 & 0.030, respectively). CONCLUSION: Although not inserting a double J stent after csPCNL has acceptable results, because of higher residual rate in staghorn stone which cause more incidence of renal colic, longer time of hospital stay and return to normal life, inserting DJ stent is recommended.

A case of de novo extra-stent ulceration induced by persistent plaque protrusion after carotid artery stenting with a CASPER stent for a large-volume unstable plaque.

Plaque protrusion (PP) has been identified as a perioperative complication of carotid artery stenosis treated with carotid artery stenting (CAS). The CASPER stent (CS), a dual-layer micromesh stent, may be able to prevent PP. Despite using CS, de novo extra-stent ulceration induced by persistent PP is rare. A 75-year-old male patient, whose superficial temporal artery-middle cerebral artery bypass tended to occlude, underwent CAS using a CS for symptomatic pseudo-occlusive internal carotid artery with a large-volume unstable plaque. This led to de novo extra-stent ulceration induced by persistent PP, resulting in ischemic stroke that necessitated the application of the stent-in-stent technique. There was no recurrence of cerebral infarction postoperatively at 12 months. Here, we present, to the best of our knowledge, the first case of a patient with de novo extra-stent ulceration induced by persistent PP after CAS that led to de novo extra-stent ulceration. The inhibition of intimal formation on the stent surface caused by persistent PP was considered to be the underlying mechanism. The stent-in-stent technique is beneficial even in cases of PP accompanied by de novo extra-stent ulceration.

The Effect of Stenting on Post-Stenotic Dilatation in Coarctation of The Aorta.

The effect of stenting of native aortic coarctation (CoA) on post-stenotic dilatation (PSD) has not been previously described. We hypothesized that CoA stenting may lead to positive remodeling of PSD. Retrospective analysis of patients who underwent stent implantation for native CoA from 1999 to 2021 was performed. Primary outcome was incremental change PSD diameter and the PSD/DescAo (Descending Aorta) following stent implantation and comparison between covered and bare-metal stents. 90 consecutive patients, (26 female, average age at first intervention 12.0 years) were included. 35 patients (38.9%) underwent dilatation with bare-metal stents and 55 patients (61.1%) with covered stents. The covered stent subgroup was older (14.0 vs. 9.2 years old, p < 0.001) and PSD was larger (17.0 vs 14.0 mm, p < 0.001). Over a mean of 3.2 years, mean inter-catheterization growth of the PSD was blunted [- 0.05 mm, 95% CI (- 1.5 to 1.4)]. The covered stent subgroup demonstrated a negative inter-catheterization growth compared to the bare-metal stent subgroup (- 0.7 vs 1.6 mm, p < 0.001). When controlled for somatic growth, the PDS/DescAo decreased more significantly among those with covered stent vs bare metal (- 0.12 vs - 0.058, p = 0.004). Stenting of native CoA blunts the growth of PSD; covered stents were significantly associated with regression of the diameter of the PSD over time compared to bare-metal stents.

A Dedicated Algorithm For Endovascular Approach As A First-Line Treatment Option for Visceral Artery Aneurysms.

OBJECTIVES: Few data are reported in literature about visceral artery aneurysms (VAAs) management. The aim of the present study was to analyze VAAs management in a single institution, with a dedicated algorithm for endovascular approach as the first line treatment. METHODS: A single center retrospective cohort study was performed. Patients with a VAA submitted to either endovascular repair or open surgery from 2016 to 2023 were included. A dedicated algorithm was used to evaluate the endovascular approach feasibility assessing on the preoperative computed tomography angiography (CTA) the following parameters: (a) the tortuosity of the involved artery (<150°), (b) the healthy arterial diameter (>4mm), (c) the VAA proximity to the hilum and/or the presence of a bifurcation of the aneurysmatic artery, and (d) the circumferential calcium presence. An endovascular approach was chosen if (a) and (b) criteria were satisfied without (c) and (d) ones. Otherwise, it was deemed a challenging anatomy, and an open surgical treatment was considered. In the absence of (a) and/or (b) criteria open surgery was the preferred option. RESULTS: Thirty-one asymptomatic aneurysms (28 patients) were treated electively. The most frequent VAA location was the splenic artery (18 cases; 58%), followed by the renal arteries (6 cases; 19%), the common hepatic artery (5 cases; 16%), the gastroepiploic artery (1 case, 3.2%) and the pancreatoduodenal artery (1 case; 3%). Twenty-two aneurysms (71%) were initially treated by an endovascular approach (stent-graft deployment and/or transcatheter embolization) with 3 (13%) of them needing a surgical conversion. Nine aneurysms (29%) were submitted directly to a surgical treatment (aneurysm resection with or without interposition bypass) with no peri-operative and long-term complications. Technical success was 90.3%. CONCLUSIONS: Endovascular management as a first line approach is safe and effective in most cases. A preoperative dedicated algorithm is useful to identify suitable cases. Open surgery can be considered an alternative option in specific challenging anatomical situations or in case of endovascular failure.

Physician-modified funnel-shaped covered stent for selective false lumen exclusion in chronic type B aortic dissection.

PURPOSE: To describe the technique of off-centering a balloon-expandable covered stent for selective occlusion of a distal entry tear (ET) in a patient, conservatively treated for chronic type B aortic dissection (cTBAD), presenting FL expansion. TECHNIQUE: A 63-year-old male, with conservatively managed cTBAD, presented at follow-up with FL partial thrombosis and expansion (thoracic aorta FL from 21 mm to 27 mm and abdominal aorta FL from 11 mm to 15 mm in 6 months). No proximal ET was identifiable. Distal FL perfusion was caused by an ET in the abdominal aorta feeding a 2 mm accessory renal artery (ARA). As the aortic diameter was below the threshold for endovascular repair, a selective occlusion of the distal ET and ARA was planned. A balloon-expandable covered stent was modified by off-centering the covered stent proximally and resulting in a funnel-shape occluder after deployment across the ET into the ARA. To prevent type Ic endoleak due to possible FL expansion caused by an intra-operatively detected phrenic artery (PA), coils were deployed into the lumen of the modified stent and the ARA. The pre-discharge computed tomography angiography showed exclusion of both the ARA and ET and a type 2 endoleak from the PA. CONCLUSION: A balloon-expandable covered stent can be modified by off-centering the covered stent resulting in a funnel shape to adapt to different diameter requirements.

Hemidystonia-hemiatrophy syndrome following placement of internal carotid artery flow diverter stent.

We report hemidystonia and cerebral hemiatrophy in a 39-year old woman beginning three months after placement of an internal carotid artery flow diverting stent for supraclinoid aneurysm, complicated by early post-procedural stroke. We highlight the unusual demographics and short latency to onset, as well as the occurrence of striatal mineralisation, which may reflect ongoing neurodegeneration, but has also been suggested to contribute to oxidative neuronal injury. The late age of the inciting cerebral insult and of onset of the movement disorder, temporal course, and relation to endovascular intervention serve to expand the spectrum of this unusual condition.

Safety and efficacy assessment of the Inno-Xmart venous stent system in managing symptomatic iliofemoral venous obstruction: a 12-month outcome analysis.

This study aims to evaluate the safety and efficacy of the dedicated Inno-Xmart braided venous stent system (Suzhou Innomed Medical Device Co., Ltd., Jiangsu, China) in treating symptomatic iliofemoral venous obstruction. This clinical study followed a prospective, multicentre, single-arm design with the application of an objective performance goal. Patients diagnosed with symptomatic iliofemoral venous obstruction who met the eligibility criteria of this study were enrolled and treated with the Inno-Xmart venous stent system. The safety endpoints included the assessment of stent fracture, satisfaction of delivery system and 12-month incidence rate of major adverse events (MAEs). The primary efficacy endpoint focused on evaluating the 12-month primary patency rate through venography as determined by core laboratory. Secondary efficacy endpoints included surgical success rate, 6-month primary patency rate and the changes in quality of life from baseline to 6- and 12-month follow-up intervals. Between September 18, 2019, and April 26, 2021, 193 patients were successfully enrolled across 18 research institutions. The surgical success rate was 95.3% (184/193), the 12-month MAE rate was 5.1% (9/178) with no stent fractures or migrations. The 12-month primary patency rate for the participants was 96.1%, significantly surpassing the literature-derived objective performance of 80% (95% confidence interval [CI], 92.1-98.4; P < 0.0001). In addition, the mean venous clinical severity score (VCSS) and Chronic Venous Disease Quality of Life Questionnaire (CIVIQ) scores at the 6- and 12-month follow-ups were significantly lower than the preoperative scores (P < 0.001). The innovative, dedicated braided venous stent designed to address symptomatic iliofemoral venous obstruction demonstrates a high technical success rate, low complication rates, and impressive mid-term (12-month) patency. It effectively enhanced the quality of life for patients and holds promising prospects for a wide range of applications. The clinical study was officially registered in the "Chinese Clinical Trial Registry" (Registration number: ChiCTR2000040216, date of registration: November 25th, 2020).

Subacute in-stent thrombosis after carotid artery stenting in a patient with gene polymorphisms associated with aspirin and clopidogrel resistance: a case report.

BACKGROUND: Carotid artery stenting (CAS) is a key treatment option for moderate to severe carotid artery stenosis. Carotid stent thrombosis (CST), a rare complication of CAS, has gained significant attention because of its catastrophic nature. More evidences are needed to guide the diagnosis and treatment of CST. CASE PRESENTATION: This study reports a rare case of sub-acute CST following CAS in a 50-year-old male patient who had experienced repeated cerebrovascular events on the premise of taking antiplatelet drugs. He also suffered an occlusion of the left middle cerebral artery (MCA) in the M2 segment, likely caused by an embolus detached from the stent thrombus. The cause of CST in this patient was presumed to be dual antiplatelet resistance (AR), as indicated by genetic testing. After treated with guide catheter-directed thrombolysis, thrombus aspiration, and a second round of thrombolysis, his in-stent thrombus was basically cleared. His M2 occlusion was resolved by mechanical thrombectomy using the Solitaire FR/Stent with Intermediate Catheter Assisting technique. The patient recovered well after replacement of antiplatelet drugs, and no new thromboembolic event occurred during the 13-month follow-up period. CONCLUSIONS: The occurrence rate of AR-related CST may be underestimated as the cause of majority CST cases remains unclear. Implementation of genetic test for aspirin and clopidogrel resistance may be helpful to find the possible cause of CST and to avoid future repeated cerebrovascular events by replacement of antiplatelet drugs.