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.

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.

Retrieval of n-Butyl Cyanoacrylate Cast Migrated to the Dorsalis Pedis and Posterior Tibial Artery During Embolization of the Deep Circumflex Iliac Artery Using the Stent Retriever Device: A Case Report.

CLINICAL IMPACT: This case highlights the innovative application of stent retriever devices for retrieving migrated NBCA casts, traditionally used for stroke management in peripheral arterial occlusions. This adaptation offers clinicians a new, effective tool for managing embolization complications, such as unintended material migration that can cause severe ischemia. Implementing this technique could change clinical practice by providing a reliable method to swiftly address and resolve potentially limb-threatening situations, thereby improving patient outcomes and procedural safety. This advancement in interventional radiology enhances clinicians' ability to handle complex embolic events with greater confidence and efficacy.

A Bridge to Curative Surgery for Obstructive Colorectal Cancer: Self-expandable Metallic Stent Versus Decompression Tube.

BACKGROUND/AIM: Self-expandable metallic stent (SEMS) placement is becoming the standard bridge-to-surgery (BTS) strategy for potentially curable left-sided obstructive colorectal cancer (OCRC). The study objective was to evaluate the effectiveness of SEMS placement as a BTS strategy for both right- and left-sided OCRC. PATIENTS AND METHODS: We retrospectively compared the short- and long-term outcomes of patients with OCRC who underwent placement of a SEMS versus a trans-nasal/anal decompression tube (DCT). The cohort comprised 57 patients with stage II/III right-sided OCRC (DCT, n=20; SEMS, n=8) or left-sided OCRC (DCT, n=9; SEMS, n=20). The short-term outcomes were the incidence of postoperative complications, rate of laparoscopic surgery, rate of stoma construction, and postoperative hospital stay; long-term outcomes were the 3-year overall survival (OS) and relapse-free survival (RFS). RESULTS: The SEMS group had a higher rate of laparoscopic surgery (85.7% vs. 6.9%, p<0.001), lower rate of stoma construction (10.7% vs. 34.5%, p=0.03), and shorter postoperative hospital stay (14 vs. 17 days, p=0.04) than the DCT group. Both groups had a similar incidence of postoperative complications. The 3-year OS and RFS were also similar in the DCT and SEMS groups for both right-sided OCRC (OS, 75.0% vs. 87.5%, HR=1.51, 95% CI=0.22-10.25, p=0.7; RFS, 65.0% vs. 50.0%, HR=0.97, 95% CI=0.28-3.36, p=0.9) and left-sided OCRC (OS, 88.8% vs. 90.0%, HR=1.19, 95% CI=0.10-14.29, p=0.9; RFS, 77.8% vs. 85.0%, HR=1.03, 95% CI=0.16-6.5, p=0.9). CONCLUSION: SEMS placement is a reasonable BTS strategy for left- and right-sided OCRC that achieves comparable short- and long-term outcomes to DCT insertion.

Endovascular stimulation of the pudendal nerve using a stent-mounted electrode array.

OBJECTIVE: Previous preclinical and clinical studies have demonstrated that pudendal nerve is a promising target for restoring bladder control. The spatial proximity between the pudendal nerve and its accompanying blood vessels in the pudendal canal provides an opportunity for endovascular neurostimulation, which is a less invasive approach compared to conventional chronically implanted electrodes. In this study, we investigated the feasibility of excitative stimulation and kilohertz-frequency block of the compound pudendal nerve in sheep using a stent-mounted electrode array. Approach: In a set of acute animal experiments, a commercially available hexapolar electrode catheter was introduced in the unilateral internal pudendal artery to deliver bipolar electrical stimulation of the adjacent compound pudendal nerve. The catheter electrode was replaced with a custom-made stent-mounted electrode array and the stimulation sessions were repeated. Global electromyogram (EMG) activity of the external urethral sphincter was recorded concurrently. Main results: We demonstrated the feasibility of endovascular stimulation of the pudendal nerve efferents with both electrode types. The threshold current of endovascular stimulation was influenced by electrode-nerve distance and electrode orientation. Increasing the axial inter-electrode distance significantly decreased threshold current. Endovascular kilohertz-frequency nerve block was possible with the electrode catheter. Significance: The present study demonstrated that endovascular stimulation of the pudendal nerve with the stent-mounted electrode array may be a promising less invasive alternative to conventional implantable electrodes, which has important clinical implications in the treatment of urinary incontinence. Endovascular blocking of pudendal nerve efferents may provide an alternative solution to the bladder-sphincter dyssynergia problem in bladder management for people with spinal cord injury. .

Meta-Analysis Comparing Drug-Coated Balloon Versus Plain Old Balloon Angioplasty for In-stent Restenosis of Coronaries.

BACKGROUND: Despite the advent of newer stents, in-stent restenosis has been a persistent and formidable challenge. Trials have demonstrated the superiority of drug-coated balloons (DCB) over plain-old balloon angioplasty (POBA). A recent AGENT IDE trial highlighted the need for a more comprehensive understanding hence we conducted a meta-analysis aimed at elucidating their respective clinical outcomes. METHODS: A literature search was conducted by 2 investigators (SS and MH) using MEDLINE (EMBASE and PubMed) using a systematic search strategy by PRISMA till November 01, 2023. CRAN-R software was used for statistical analysis. The quality assessment was performed using the Cochrane Risk of Bias tool (Supplemental Table 5). RESULTS: We included 6 studies with a total of 1171 patients. Our analysis showed decreased odds of multiple outcomes with statistically significant results including TVR (OR 0.33, CI 0.19-0.57), TVF (OR 0.30, CI 0.09-0.99), TLR (OR 0.22, CI 0.10-0.46), restenosis (OR 0.1343, CI 0.06-0.27), and MACE (OR 0.2 CI 0.12-0.37). Although MI and all-cause mortality showed decreased odds with all-cause mortality at 0.8 (95% CI: 0.363-2.09), and MI at 0.6 (95% CI: 0.0349-1.07), the reductions did not reach statistical significance. CONCLUSION: Our analysis by scrutinizing six RCTs favored DCB over POBA. However, extensive research for deeper understanding cannot be overemphasized.

Management of Central Airway Obstruction. An American College of Chest Physicians Clinical Practice Guideline.

BACKGROUND: Central airway obstruction (CAO), seen in a variety of malignant and non-malignant airway disorders, is associated with a poor prognosis. The management of CAO is dependent on provider training and local resources, which may make the clinical approach and outcomes highly variable. We reviewed the current literature and provided evidence-based recommendations for the management of CAO. METHODS: A multidisciplinary expert panel developed key questions using the PICO (Patient, Intervention, Comparator, and Outcomes) format and conducted a systematic literature search using MEDLINE (PubMed) and the Cochrane Library. The panel screened references for inclusion and used vetted evaluation tools to assess the quality of included studies and extract data, and graded the level of evidence supporting each recommendation. A modified Delphi technique was used to reach consensus on recommendations. RESULTS: Nine thousand, six hundred and eighty-eight abstracts were reviewed, 150 full-text articles were assessed, and 31 studies were included in the analysis. One good practice statement and ten graded recommendations were developed. The overall certainty of evidence was very low. CONCLUSIONS: Therapeutic bronchoscopy can improve the symptoms, quality of life, and survival of patients with malignant and non-malignant CAO. Multi-modality therapeutic options, including rigid bronchoscopy with general anesthesia, tumor/tissue debridement, ablation, dilation, and stent placement should be utilized when appropriate. Therapeutic options and outcomes are dependent on the underlying etiology of CAO. A multidisciplinary approach and shared decision-making with the patient are strongly encouraged.

Single centre mid-term experience with E-liac branched device from Artivion®.

INTRODUCTION: The use of iliac branch device (IBD) is increasing due to the less invasive character and accumulated experience of physicians in this endovascular technique. Clinical data regarding the E-liac stent graft from Artivion®, however, are scarce. This study shows the mid-term outcomes of the E-liac stent graft from a large single centre. METHODS: Patients treated with IBD for (aorto-)iliac aneurysms between September 2015 and December 2022 with follow-up in our centre were included. (Post)operative (technical success, reintervention, 30-day mortality) and mid-term outcomes (endoleak, reintervention, hypogastric patency, mortality) were analysed. RESULTS: Sixty-three patients (60 male, median age 70 years (IQR 66-;76)) were treated with 82 E-liac stent grafts for aorto-iliac aneurysms with a median follow-up of 38 months (IQR 22-51). The technical success rate was 95%. 97.6% of the interal iliac arteries remained patent during follow-up. No 30-day mortality was encountered. During follow-up one patient had an endoleak type 1b of both hypogastric arteries, however the patient refused additional interventions. One other patient had a type 2 endoleak with contained rupture. Paliative treatment was chosen because of the patient's severe comorbidities. One (1.6%) IBD-related reintervention was performed with relining of the stent graft. Secondary patency of the interal iliac artery was 95.1% and the mortality was 25.4% during follow-up. CONCLUSIONS: This study shows high technical success rates for the E-liac stent graft, with corresponding good mid-term outcomes. The E-liac stent graft is a feasible, safe and effective stent graft in the treatment of aorto-iliac aneurysms.

Risk factors for recurrent biliary obstruction following suprapapillary placement of a plastic stent as preoperative biliary drainage for perihilar biliary malignancy.

BACKGROUND/PURPOSE: The usefulness of endoscopic biliary stenting by deploying a plastic stent suprapapillary, called inside-stent (IS) placement, as preoperative biliary drainage (PBD) for perihilar biliary malignancy (PHBM) has been demonstrated. This study investigated risk factors for recurrent biliary obstruction (RBO) after IS placement. METHODS: Consecutive patients with potentially resectable PHBM treated with IS placement as PBD between 2017 and 2023 at Nagoya University Hospital were retrospectively reviewed. RESULTS: A total of 157 patients were included, with RBO occurring in 34 (22%) patients. The non-RBO rates were 83% at 30 days, 77% at 60 days, and 57% at 90 days. The most common cause of RBO was stent occlusion (n = 14), followed by segmental cholangitis (n = 12) and stent migration (n = 8). Stent migration and occlusion occurred more frequently within and after 1 week post-stenting, respectively. In multivariate analysis, biliary infection before IS was the sole risk factor for RBO, with a hazard ratio of 2.404 (95% confidence interval 1.163-4.972; p = .018). This risk was reduced by temporary endoscopic nasobiliary drainage prior to definitive IS placement. CONCLUSIONS: Biliary infection before IS was identified as an independent risk factor for RBO in patients with PHBM with IS as PBD. CLINICAL TRIAL REGISTER: Clinical trial registration number: UMIN000025631.

Endovascular Treatment of "Donut-Shaped" Aneurysm-A Case Series.

Background and Objectives: Partially thrombosed aneurysms represent a subset primarily found within large and giant aneurysms. The presence of an intraluminal thrombus can cause an aneurysm to present in different shapes upon angiographic examination. We present a series of five cases of "donut-shaped" aneurysms observed over the past decade at the Clinic for Neurosurgery in the University Clinical Centre of Serbia. Materials and Methods: The management of "donut-shaped" aneurysms was accomplished through endovascular interventions, employing techniques such as the deployment of flow-diverting stents or a combination of stent placement and coil embolization. Results: Four out of five patients underwent endovascular treatment, yielding positive outcomes with complete thrombosis of the aneurysms during follow-up. The fifth patient was successfully diagnosed; however, due to their deteriorating condition, treatment was not feasible. Conclusions: Given the potential life-threatening complications associated with this entity, accurate diagnosis and appropriate management are crucial. In our cohort, endovascular interventions demonstrated efficacy in the majority of cases, underscoring the significance of this approach in treating "donut-shaped" aneurysms. Nevertheless, considering the rarity of this condition, further research is justified to refine diagnostic and therapeutic strategies for these complex intracranial vascular anomalies.

BeGraft Aortic Stents: A European Multi-Centre Experience Reporting Acute Safety and Efficacy Outcomes for the Treatment of Vessel Stenosis in Congenital Heart Diseases.

BACKGROUND: Stent implantation has become the preferred method of treatment for treating vessel stenosis in congenital heart diseases. The availability of covered stents may decrease complications and have an important role in the management of patients with complex anatomy. AIM: This study aims to evaluate the feasibility and safety of the pre-mounted cobalt-chromium stent-graft-covered ePTFE Aortic BeGraft in a broad spectrum of vascular lesions. METHODS: This is a multicenter retrospective results analysis of 107 implanted BeGraft stents between 2016 and 2022 in six different European centers. RESULTS: One hundred and four patients with a mean age of thirteen years (range 1-70 years) and with the body weight of 56.5 kg (range 11-115 kg) underwent the BeGraft stent implantation. Stents were implanted in the following conditions: aortic coarctation (74 patients), RVOT dysfunction (12 patients), Fontan circulation (7 patients), and miscellaneous (11 subjects with complex CHD). All the stents were implanted successfully. The median stent diameter was 16 mm (range 7-24 mm), and the median length was 39 mm (range 19-49 mm). Major complications occurred in five subjects (4.7%). During a median follow-up of fourteen (1-70) months, stents' re-dilatation was performed in five patients. CONCLUSIONS: The BeGraft stent can be used safely and effectively in a wide spectrum of congenital heart diseases. Whether these good results will be stable in the longer term still needs to be investigated in a follow-up given its recent introduction into clinical practice, in particular regarding stent fracture or neointimal proliferation.

Elucidating the Relationship between Neutrophil-Lymphocyte Ratio and Plaque Composition in Patients with Drug-Eluting Stent Restenosis by Virtual Histology-Intravascular Ultrasound.

(1) Background: In-stent Restenosis (ISR) is a major factor influencing the prognosis and revascularization of target lesions. The plaque composition is unclear; therefore, it is critical to investigate ISR composition to identify clinical intervention markers. (2) Methods: This study was conducted on 36 patients with drug-eluting stent restenosis. The patients were classified into a Low Neutrophil-Lymphocyte Ratio (L-NLR) and High Neutrophil-Lymphocyte Ratio (H-NLR) according to the median NLR level of 36 patients. Discrepancies in the current information such as baseline data, biochemical examination, cardiac ultrasound data, etc., were examined to identify the underlying risk factors, and a multifactorial linear regression analysis of plaque properties was conducted. (3) Results: NLR = 2.64 was utilized to classify 18 patients into the L-NLR group and 18 patients into the H-NLR group. There were statistically significant differences in age, a pre-percutaneous coronary intervention (PCI) SYNTAX II score, a C-reactive protein (CRP), interleukin (IL)-6, plaque loading, a fibro-lipid tissue area, calcified nubs, and virtual histology-thin fibrous cap atherosclerotic (VH-TCFA). The significant impacts of variations in age, neutrophil-lymphocyte ratio (NLR) levels, and IL-6 levels on the plaque stress and percentage of the fibro-lipid tissue in virtual histology-intravascular ultrasound (VH-IVUS) were identified through multifactorial linear regression. (4) Conclusions: The high NLR group demonstrated increased myocardial injury severity, consistent with higher SYNTAX II scores, a higher plaque burden, and higher proportions of vulnerable components. NLR proved to be a risk factor for both the plaque load and the proportion of the fibro-lipid tissue in ISR.

Pharmacomechanical Thrombectomy and Catheter-Directed Thrombolysis, with or without Iliac Vein Stenting, in the Treatment of Acute Iliofemoral Deep Vein Thrombosis.

BACKGROUND: This study aims to evaluate and compare the outcomes and clinical efficacy of pharmacomechanical thrombectomy (PMCT) plus catheter-directed thrombolysis (CDT) and PMCT combined with CDT and venous stenting in managing acute iliofemoral deep vein thrombosis (DVT), while also assessing the long-term safety and efficacy of these interventions. METHODS: A retrospective case-control study spanning 3 years involved 112 patients presenting with acute symptomatic iliofemoral deep vein thrombosis (DVT), each with a symptom duration of less than 14 days. Patients were consecutively categorized into two groups based on individual clinical indications: PMCT + CDT vs. PMCT + CDT + venous stent. Statistical analyses were conducted to compare clinical features and outcomes between the two groups. Additionally, patients were followed up for 24 months post-treatment, during which quality of life (QoL) and severity of post-thrombotic syndrome (PTS) were analyzed. RESULTS: In this retrospective study, we analyzed a total of 112 consecutive patients, with 63 patients undergoing PMCT + CDT and 49 patients undergoing PMCT + CDT + venous stent. Between the two groups, regarding primary outcomes at 6 months, there was no difference in the observed cumulative patency rates, standing at 82.5% for PMCT + CDT and 81.6% for PMCT + CDT + stent. Survival analyses for primary, primary-assisted, and secondary patency yielded comparable results for PMCT + CDT, with p-values of 0.74, 0.58, and 0.72, respectively. The two-year patency rate was high in both groups (85.7% for PMCT + CDT vs. 83.7% for PMCT + CDT + stent). Additionally, during the follow-up period, there were no statistically significant differences observed in the incidence of PTS or the average Villalta score between the two groups. At 24 months post-intervention, the incidence of post-thrombotic syndrome (PTS) was 11.1% in the PMCT + CDT group and 22% in the PMCT + CDT + stent group (p = 0.381). Both treatment arms of the study groups experienced bleeding complications during the thrombolysis therapy; in the PMCT + CDT group, there were three cases of gastrointestinal bleeding, compared to two cases in the PMCT + CDT + stent group (p = 0.900). Additionally, there was one intracranial hemorrhage in the PMCT + CDT group and two in the PMCT + CDT + stent group. CONCLUSIONS: Pharmacomechanical thrombectomy (PMCT) combined with catheter-directed thrombolysis (CDT) therapy has shown significant efficacy in alleviating leg symptoms and reducing the occurrence of post-thrombotic syndrome (PTS), including the incidence of moderate-to-severe PTS. On the other hand, the utilization of PMCT + CDT + stent therapy, tailored to individual patients' clinical and venous conditions, may enhance long-term venous patency and lead to superior outcomes, including improved quality of life parameters.

Impact of Chronic Kidney Disease on the Coronary Revascularization Guided by Intracoronary Physiology: Results of the First Registry with Long-Term Follow-Up in a Latin American Population.

The use of invasive physiology methods in patients with renal dysfunction is not well elucidated. Our objective was to evaluate the in-hospital and long-term results of using intracoronary physiology to guide revascularization in patients with chronic kidney disease. In this retrospective study, we evaluated 151 patients from January 2018 to January 2022, divided into 2 groups: CKD (81 patients [114 lesions]) and non-CKD (70 patients [117 lesions]). The mean age was higher (p < 0.001), body mass index was lower (p = 0.007), contrast volume used was lower (p = 0.02) and the number of ischemic lesions/patients was higher (p = 0.005) in the CKD group. The primary outcomes (rate of major adverse cardiac events during follow-up, defined as death, infarction, and need for new revascularization) in the CKD and non-CKD groups were 22.07% and 14.92%, respectively (p = 0.363). There was a significant difference in the target lesion revascularization (TLR) rate (11.68%, CKD group vs. 1.49%, non-CKD group, p = 0.02), this initial statistical difference was not significant after adjusting for variables in the logistic regression model. There was no difference between the rates of death from all causes (6.49%, CKD group vs. 1.49%, non-CKD group, p = 0.15), reinfarction (3.89%, CKD group vs. 1.49%, non-CKD group, p = 0.394), and need for new revascularization (11.68%, CKD group vs. 5.97%, non-CKD group, p = 0.297). As there was no difference in the endpoints between groups with long-term follow-up, this study demonstrated the safety of using intracoronary physiology to guide revascularization in patients with CKD.

A glaucoma micro-stent with diverging channel and stepped shaft structure based on microfluidic template processing technology.

BACKGROUND: Minimally invasive glaucoma surgery (MIGS) has experienced a surge in popularity in recent years. Glaucoma micro-stents serve as the foundation for these minimally invasive procedures. Nevertheless, the utilization of these stents still presents certain short-term and long-term complications. This study aims to elucidate the creation of a novel drainage stent implant featuring a diverging channel, produced through microfluidic template processing technology. Additionally, an analysis of the mechanical properties, biocompatibility, and feasibility of implantation is conducted. RESULTS: The stress concentration value of the proposed stent is significantly lower, approximately two to three times smaller, compared to the currently available commercial XEN gel stent. This indicates a stronger resistance to bending in theory. Theoretical calculations further reveal that the initial drainage efficiency of the gradient diverging drainage stent is approximately 5.76 times higher than that of XEN stents. Notably, in vivo experiments conducted at the third month demonstrate a favorable biocompatibility profile without any observed cytotoxicity. Additionally, the drainage stent exhibits excellent material stability in an in vitro simulation environment. CONCLUSIONS: In summary, the diverging drainage stent presents a novel approach to the cost-effective and efficient preparation process of minimally invasive glaucoma surgery (MIGS) devices, offering additional filtering treatment options for glaucoma.

"Unkinking" the "Kink" Normalizes the Doppler Pattern.

Coarctation of the aorta (CoA) comprises 5-7% of congenital heart disease and can present as an isolated narrowing in the aortic arch just distal to the left subclavian artery or can be associated with cardiac abnormalities such as a bicuspid aortic valve, aortopathy, or ventricular septal defects. With the advances in the medical field, intervention on CoA can either be via surgical repair or endovascular stenting. Echocardiography is the mainstay in diagnosing CoA, with tomographic imaging such as magnetic resonance imaging (MRI) or computed tomography providing supplementary assessment of the aorta, valves, and collateral vessels. We present a case of a young hypertensive male who was noted to have a continuous cardiac murmur with diagnostic Doppler pattern of CoA on echocardiography that normalized soon after percutaneous stenting.

Investigation of Degradation and Biocompatibility of Indirect 3D-Printed Bile Duct Stents.

This study proposes a bile duct stent based on indirect 3D printing technology. Four ratio materials were synthesized from lactic acid (LA) and glycolide (GA) monomers by melt polymerization: PLA, PLGA (70:30), PLGA (50:50), and PLGA (30:70). The four kinds of material powders were preliminarily degraded, and the appearance was observed with an optical microscope (OM) and a camera. The weight and appearance of the four materials changed significantly after four weeks of degradation, which met the conditions for materials to be degraded within 4-6 weeks. Among them, PLGA (50:50) lost the most-the weight dropped to 13.4%. A stent with an outer diameter of 10 mm and an inner diameter of 8 mm was successfully manufactured by indirect 3D printing technology, demonstrating the potential of our research. Then, the degradation experiment was carried out on a cylindrical stent with a diameter of 6 mm and a height of 3 mm. The weight loss of the sample was less than that of the powder degradation, and the weight loss of PLGA (50:50) was the largest-the weight dropped to 79.6%. The nano-indenter system measured the mechanical properties of materials. Finally, human liver cancer cells Hep-3B were used to conduct in vitro cytotoxicity tests on the scaffolds to test the biocompatibility of the materials. A bile duct stent meeting commercial size requirements has been developed, instilling confidence in the potential of our research for future medical applications.

A multi-center study of the MicroNET-covered stent in consecutive patients with acute carotid-related stroke: SAFEGUARD-STROKE.

Introduction: Acute carotid-related stroke (CRS), with its large thrombo-embolic load and large volume of affected brain tissue, poses significant management challenges. First generation (single-layer) carotid stents fail to insulate the athero-thrombotic material; thus they are often non-optimized (increasing thrombosis risk), yet their use is associated with a significant (20-30%) risk of new cerebral embolism. Aim: To evaluate, in a multi-center multi-specialty investigator-initiated study, outcomes of the MicroNET-covered (cell area ≈ 0.02-0.03 mm2) carotid stent (CGuard, InspireMD) in consecutive CRS patients eligible for emergency recanalization. Treatment, other than study device use, was according to center/operator routine. Material and methods: Seventy-five patients (age 40-89 years, 26.7% women) were enrolled in 7 interventional stroke centers. Results: The median Alberta Stroke Program Early CT Score (ASPECTS) was 9 (6-10). Study stent use was 100% (no other stent types implanted); retrograde strategy predominated (69.2%) in tandem lesions. Technical success was 100%. Post-dilatation balloon diameter was 4.0 to 8.0 mm. 89% of patients achieved final modified Thrombolysis in Cerebral Infarction (mTICI) 2b-c/3. Glycoprotein IIb/IIIa inhibitor use as intraarterial (IA) bolus + intravenous (IV) infusion was an independent predictor of symptomatic intracranial hemorrhage (OR = 13.9, 95% CI: 5.1-84.5, p < 0.001). The mortality rate was 9.4% in-hospital and 12.2% at 90 days. Ninety-day mRS0-2 was 74.3%, mRS3-5 13.5%; stent patency was 93.2%. Heparin-limited-to-flush predicted patency loss on univariate (OR = 14.3, 95% CI: 1.5-53.1, p < 0.007) but not on multivariate analysis. Small-diameter balloon/absent post-dilatation was an independent predictor of stent patency loss (OR = 15.2, 95% CI: 5.7-73.2, p < 0.001). Conclusions: This largest to-date study of the MicroNET-covered stent in consecutive CRS patients demonstrated a high acute angiographic success rate, high 90-day patency and favorable clinical outcomes despite variability in procedural strategies and pharmacotherapy (SAFEGUARD-STROKE NCT05195658).

Development and clinical implementation of a digital workflow utilizing 3D-printed oral stents for patients with head and neck cancer receiving radiotherapy.

OBJECTIVES: We describe the development of 3D-printed stents using our digital workflow and their effects on patients enrolled in the lead-in phase of a multi-center, randomized Phase-II trial. MATERIALS AND METHODS: Digital dental models were created for patients using intraoral scanning. Digital processes were implemented to develop the mouth-opening, tongue-depressing, and tongue-lateralizing stents using stereolithography. Time spent and material 3D-printing costs were measured. Physicians assessed mucositis using the Oral Mucositis Assessment Scale (OMAS) and collected MD Anderson Symptom Inventory (MDASI) reports and adverse events (AEs) from patients at various time points (TPs). OMAS and MDASI results were evaluated using paired t-test analysis. RESULTS: 18 patients enrolled into the lead-in phase across 6 independent clinical sites in the USA. 15 patients received stents (average design and fabrication time, 8 h; average material 3D-printing cost, 11 USD). 10 eligible patients with complete OMAS and MDASI reports across all TPs were assessed. OMAS increased significantly from baseline to week 3 of treatment (mean difference = 0.34; 95 % CI, 0.09-0.60; p = 0.01). MDASI increased significantly from baseline to week 3 of treatment (mean difference = 1.02; 95 % CI, 0.40-1.70; p = 0.005), and week 3 of treatment to end of treatment (mean difference = 1.90; 95 % CI, 0.90-2.92; p = 0.002). AEs (grades 1-3) were reported by patients across TPs. Mucositis and radiation dermatitis were primarily attributed to chemoradiation. CONCLUSIONS: 3D-printed stents were successfully fabricated and well tolerated by patients. As patients enroll in the randomized phase of this trial, data herein will establish a baseline for comparative analysis.