Outcomes Of Stenting Research Articles

Long-term outcomes of carotid stenting in a single neurovascular center: up to 12-year retrospective analysis with a focus on the influence of comorbidities.

The aim of this study was to evaluate long-term outcomes in patients who underwent carotid artery stenting (CAS) for symptomatic or asymptomatic high-grade stenosis. A total of 1158 patients (asymptomatic, n = 636; symptomatic, n = 522) underwent CAS at our center between 2009 and 2020. A total of 560 patients or contacts (asymptomatic, n = 316; symptomatic, n = 244) were interviewed by telephone to evaluate long-term outcomes with a mean follow-up of 5 years. Mortality from all causes, myocardial infarction, and stroke, as well as comorbidities influencing their occurrence, including overall survival and stroke-free survival, were examined. The overall survival rate for all-cause mortality was 91.6% at 1 year, 77.1% at 5 years, and 55.7% at 10 years. A total of 39 (6.9%) patients had an ischemic stroke during long-term follow-up. The stroke-free survival rates at 1 year, 5 years, and 10 years were 97.9%, 92.7%, and 86.6%, respectively. Stroke-free survival and overall survival did not differ significantly between the symptomatic and asymptomatic groups (overall survival, p = 0.304; stroke-free survival, p = 0.336). Regular physical activity reduced the risk of stroke and death and was associated with better long-term clinical outcomes. Age at treatment and diabetes mellitus were statistically significantly associated with death during follow-up. Long-term follow-up data confirmed the effectiveness and durability of CAS as a therapy option for both symptomatic and asymptomatic patients. In patient selection for CAS, special consideration should be paid to patient age, ability to engage in physical activity, and diabetes mellitus.

Impact of Medina classification on clinical outcomes of imaging-guided coronary bifurcation stenting

BackgroundIntracoronary imaging improves clinical outcomes after stenting of complex coronary bifurcation lesions (CBLs), but the impact of Medina classification-based CBL distribution on outcomes of imaging-guided bifurcation stenting is unclear. MethodsIn this integrated analysis of four previous studies, in which all CBLs were treated with drug-eluting stents under intravascular ultrasound or optical coherence tomography guidance, the distribution of 763 CBLs was assessed using angiographic Medina classification. Major adverse cardiac events (MACE), including target lesion revascularization (TLR), myocardial infarction, stent thrombosis, and cardiac death, were investigated at 1-year follow-up. ResultsThe most and least prevalent Medina subtypes were 0-1-0 (27.9 %) and 0-0-1 lesions (2.8 %). The most and least frequent MACE/TLR rates were 18.2 %/18.2 % for 0-0-1 lesions and 4.1 %/2.8 % for 0-1-0 lesions. Risks were higher for 0-0-1 lesions than for 0-1-0 lesions for both MACE (hazard ratio [HR]: 4.04, 95 % confidence interval [CI]: 1.21–13.45, p = 0.02) and TLR (HR: 6.19, 95 % CI: 1.69–22.74, p = 0.006). MACE rates were similar for true and non-true CBLs excluding 0-0-1 lesions (8.2 % and 5.9 %, HR 1.54, 95 % CI: 0.86–2.77, p = 0.15), while MACE (HR: 3.25, 95 % CI: 1.10–9.63, p = 0.03) and TLR (HR: 4.24, 95 % CI: 1.38–12.96, p = 0.01) risks were higher for 0-0-1 lesions. ConclusionsThis integrated analysis of imaging-guided bifurcation stenting demonstrated similar clinical outcomes in true and non-true CBLs, except for 0-0-1 lesions, which had a significantly higher risk of MACE/TLR.

DRUG-ELUTING STENTS OUTCOMES IN DIABETICS WITH CORONARY ARTERY DISEASE AND PULMONARY IMPLICATIONS

The study aims to investigate the outcomes of drug-eluting stents (DES) in patients with diabetes mellitus and coronary artery disease (CAD) while considering implications for pulmonary and cardiac health. A prospective observational study design was employed. A cohort of 54 patients who underwent percutaneous coronary intervention (PCI) with DES implantation was included. Primary outcome measures included stent patency rates, restenosis rates, major adverse cardiovascular events (MACE), and pulmonary function tests. Subgroup analyses were conducted based on age and gender. The study unveiled a 91.5% stent patency rate at six months and a 12.3% restenosis rate. Furthermore, the cumulative MACE incidence at one year was 18.5%. Subgroup analysis identified gender-based differences in restenosis rates and a slightly elevated MACE incidence among patients with longer diabetes duration. Importantly, pulmonary function tests, encompassing spirometer and lung volume assessments, demonstrated no significant pulmonary impairment following DES implantation. These assessments indicated only a marginal 1.2% reduction in FEV1, while TLC remained statistically unchanged, reassuring that DES utilization does not adversely impact pulmonary health. This study contributes to the growing body of evidence supporting the use of DES as a viable intervention in managing CAD in diabetic patients with potential implications for both cardiac and pulmonary health. The outcomes highlight DES's potential to enhance long-term cardiovascular effects in this high-risk population.

Balloon-expandable cheatham-platinum stents versus self-expandable nitinol stents in coarctation of aorta: 3-year outcome of a randomized clinical trial

Abstract Introduction Although stenting showed early promising results in the treatment of patients with coarctation of aorta (CoA), its long-term benefit it is scarcely studied. Previously, we have shown, balloon-expandable stents (BES) and self-expandable (SES) stents were both effective and safe during 12-month follow up in the treatment of native CoA. Purpose To report the 3-year outcomes of BES versus SES stents in patients with native CoA. Methods Adult patients with de novo native CoA were randomized into Cheatham-platinum BES and uncovered nitinol SES groups in this parallel-group, open-label, blinded endpoint randomized clinical trial. All randomized patients were assigned to the 3-year structural follow up, consisted of clinical examination (including blood pressure measurement), exercise test for detecting masked hypertension, aortic CT angiography and transthoracic echocardiography. The 3-year incidence of recoarctation of aorta, thoracic aortic aneurysm formation, and residual hypertension were reported as the main long-term outcomes. Results Of the 92 patients initially randomized, 71 patients were participated in 3-year structural follow-up (Figure 1). Residual hypertension, defined as a persistent need for antihypertensive drugs at 3-year were significantly higher in BES (25 (71.4%) versus 17 (47.2%) patients (risk ratio (RR), 1.51, 95% confidence interval (CI), [1.00 to 2.26], p= 0.03) (Figure 2). Apart from five patients diagnosed with recoarctation during the first year of follow-up, no new cases of recoarctation were detected between 1 to 3-year follow up. Of note 2 of 3 patients with recorctation in the BES group, needed a second reintervention during the long-term follow up. Thoracic aortic aneurysm formation was not different in both stent types (4 (11.4%) versus 2 (5.6%) patients (RR, 2.06, 95% CI, [0.40 to 10.52], p= 0.37). Three-year median differences of ascending aorta and aortic arch were not different between the two groups. Conclusion Overall, both BES and SES were safe and effective in the long-term follow up. The rate of recoarctation was low even in the long-term follow up, which were safely reintervene. A hypothesis-generating difference were detected between two types of stents on residual hypertension which needs to be verified in larger studies.Baseline Characteristics and Study Flow3-year Outcomes

Abstract 14765: Long-Term Outcomes of Second-Generation Drug-Eluting Stents versus Coronary Artery Bypass Graft: A Sistematic Review and Meta-Analysis

Introduction: Long-term data is limited on the comparative outcomes of percutaneous coronary intervention (PCI) with second-generation drug-eluting stents (S-DES) versus coronary artery bypass grafting (CABG) in patients with coronary artery disease (CAD). Hypothesis: Our aim was to conduct a systematic review and meta-analysis comparing mortality and cardiovascular outcomes in patients with left main or multivessel CAD who underwent PCI with an S-DES versus CABG with a minimum mean follow-up period of 3 years. Methods: We searched PubMed, Embase, and Cochrane for studies that examined our clinical question. Three reviewers independently performed study selection and data extraction. Statistical analysis was performed using Review Manager 5.4.1. We calculated pooled hazard ratios (HR) with 95% confidence intervals (CI) under a random effects model. The data from observational studies were extracted and pooled as multivariable-adjusted HR or propensity score matching to minimize confounding. Results: We included 10 studies, 2 of which were randomized controlled trials (RCT), with a total of 25,866 patients, of whom 11,482 (44.3%) underwent PCI. The mean follow-up ranged from 3.0 to 11.8 years. S-DES had a significantly higher risk than CABG for all-cause mortality (HR 1.36; 95% CI 1.10-1.68; p=0.005) and myocardial infarction (MI) (HR 1.89; 95% CI 1.12-3.18; p=0.02). No significant difference between the groups was found for major cardiovascular events (HR 1.10; 95% CI 0.98-1.23; p=0.11) and stroke (HR 0.83; CI: 0.60-1.15; p=0.27). In a subgroup analysis of RCTs, there was no significant difference between patients who underwent S-DES or CABG. Conclusion: In this meta-analysis of RCTs and multivariable or propensity-matched observational studies, our findings suggest that PCI with S-DES is associated with an increased risk of mortality and MI events compared with CABG in patients with left main or multivessel CAD.

Diabetes, Hypertension, and Smoking Do Not Affect Outcomes of Iliofemoral Vein Stenting for Chronic Proximal Venous Outflow Obstruction

ObjectiveDiabetes, hypertension, and smoking are well-recognized risk factors for Peripheral Artery Disease (PAD), but little is known of their impact on chronic venous insufficiency (CVI). This study evaluates these factors in patients undergoing iliac vein stenting (IVS) for CVI. MethodsA registry of 708 patients who underwent IVS from August 2011 to June 2021 was retrospectively analyzed. Symptoms were quantified using venous clinical severity score (VCSS) and CEAP classification. Both major and minor reinterventions were recorded. Logistic regression models were used to determine the unadjusted and adjusted odds ratio (OR) of any reintervention. Log-rank test was used to assess differences in reintervention-free survival. ResultsThe prevalence of hypertension was 51.1% (N = 362), diabetes was 23.0% (N = 163), and smoking was 22.2% (N = 157). Patients with diabetes (3.6 vs 3.4; P = 0.062), hypertension (3.6 vs. 3.3; P < 0.001), and smoking (3.7 vs 3.4; P = 0.003) had higher CEAP scores than those without these comorbidities. Improvement in VCSS composite scores showed no differences postoperatively (Diabetes: P = 0.513; Hypertension: P = 0.053; Smoking: P = 0.608), at 1-year follow-up (Diabetes: P = 0.666; Hypertension: P = 0.681; Smoking: P = 0.745), or at 5-year follow-up (Diabetes: P = 0.525; Hypertension: P = 0.953; Smoking: P = 0.146). Diabetes (P = 0.454), smoking (P = 0.355), and hypertension (P = 0.727) were not associated with increased odds of major reintervention. Log-rank test similarly showed no differences in reintervention-free survival for major or minor reoperations between those with and without diabetes (P = 0.79), hypertension (P = 0.14), and smoking (P = 0.80). ConclusionsDiabetes, hypertension, and smoking were prevalent among CVI patients, but unlike in PAD patients, they had little to no impact on long-term outcomes or reinterventions after IVS.

Abstract 16935: Distressed Community Index in Patients Undergoing Carotid Artery Stenting in Medicare-Linked Vascular Quality Initiative Registry

Introduction: Patients with high community-level socioeconomic distress have worse cardiovascular outcomes, yet its impact on carotid artery stenting (CAS) outcomes is unknown. We assessed the association between the Distressed Community Index (DCI), a zip-code level measure of community distress, with post-CAS mortality and stroke. Methods: We used the Vascular Quality Initiative database linked with Medicare claims outcomes data to identify patients undergoing CAS between 2015 and 2019. From a time-dependent ROC curve and using Youden index, we classified patients as high community distress if DCI≥65. Thirty-six-month cumulative mortality incidence using Kaplan-Meier by DCI groups, and hierarchical Cox regression with random intercept for site for linear DCI were used. For stroke, we used 36-month cumulative incidence function by DCI groups, and Fine and Gray models accounting for competing risk of death for linear DCI. Models were later adjusted for patient and procedural characteristics. Results: The final complete-case cohort included 8,595 patients (2,580/30% DCI≥65), had a mean age of 74.7 (±7.8) years, was 92.7% white and 97.6% non-Hispanic/Latino. The 36-month cumulative mortality incidence was similar in both groups (26.0% vs 22.5%, P=0.236). A 10-point increase in DCI did not increase mortality risk (unadjusted HR 1.00; 95% CI 0.98-1.03 and adjusted HR 1.01; 95% CI 0.87-1.17). At 36 months the high community distress group experienced higher stroke risk (29.8% vs 22.9%, P=0.008). However, a 10-point increase in DCI did not increase stroke risk (unadjusted sub-HR: 1.01; 95% CI 0.99-1.03, adjusted sub-HR: 1.00; 95% CI 0.98-1.02). Conclusions: In this selective set of patients with underrepresentation of demographic groups, for those who get prioritized to CAS, higher community distress was associated with an increased unadjusted 36-month stroke risk by DCI group. However, a 10-point increase in DCI was nonsignificant regardless of adjustment.

12-Month Outcomes of Carotid Artery Stenting With CGuard MicroNET-Covered Stent: A Single-Center Study in 113 Patients.

Dual layer mesh stents constitute a novel treatment option for patients who undergo carotid artery stenting (CAS). The aim of this prospective study is to report 12month outcomes of patients who underwent CAS with CGuard (Inspire MD, Tel Aviv, Israel) microNET self-expanding stent with embolic protection system in a tertiary center from October 2018 to March 2022. Primary endpoints included in-stent restenosis >70% verified by ultrasound (DUS), ipsilateral transient ischemic attack (TIA), and stroke at 12months. Secondary endpoints included cardiovascular-related mortality (stroke, myocardial infarction, heart failure) and all-cause mortality during follow-up. One hundred thirteen patients were included in the study (male 72.5%), symptomatic 47.8%. Median follow-up was 25months (2-48). By 12months, there was one in-stent occlusion that manifested as stroke (1/113, 0.8%) but no other forms of in-stent restenosis. Two patients experienced contralateral TIA (1.7%). CVRM was 3.5% (4 MI) and all-cause mortality was 6% at follow-up. This prospective study shows that CAS with CGuard MicroNET-covered stent is safe with minimal neurological adverse events at 12months follow-up. Larger, and longer-term studies are necessary to define CGuard long-term safety and protection against carotid-related stroke.

Coronary Intravascular Lithotripsy for Treatment of Severely Calcified Lesions: Long-Term Sex-Specific Outcomes.

Intravascular lithotripsy (IVL) for calcified lesion preparation prior to drug-eluting stent placement has high procedural success and safety, especially in women, whereas other atheroablative approaches are associated with increased procedural complications. We sought to investigate long-term sex-based outcomes of IVL-facilitated stenting. We performed a patient-level pooled analysis of the single-arm Disrupt CAD III and IV studies. Patient baseline, procedural characteristics, and outcomes were examined according to sex at 30 days and 1 year. The primary end point was major adverse cardiac events (a composite of cardiac death, all myocardial infarction, or target vessel revascularization). Target lesion failure was defined as cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization. A total of 448 patients, 106 (24%) women, were included. Women were older and less likely to be smokers. Women had smaller reference vessel diameters (2.8 mm vs 3.1 mm), shorter lesion length (23.6 mm vs 27.1 mm), and shorter total calcified length (44.4 mm vs 49.3 mm) compared with men. Post-IVL angiographic outcomes and complications were similar between women and men. At 1 year, major adverse cardiac event rates (12.3% vs 13.2%, P = .52) were not different between women and men. There were no differences between women and men (10.4% vs 11.2%; P = .43) in target lesion failure at 1 year. Use of IVL in the treatment of severely calcified lesions is associated with low rates of adverse clinical events and with similar safety and effectiveness in women and men at 1 year.

Outcomes of Provisional Stenting With Versus Without Side Branch Intervention in Patients With Bifurcation Lesion–Related ST-Segment Elevation Myocardial Infarction

To date, the best approach to coronary bifurcation lesion remains unsettled, and the parameters to guide side branch ballooning or stenting are not yet defined. This study aimed to compare the survival outcomes after provisional stenting with versus without side branch intervention. A cohort was conducted on 132 patients who underwent coronary angiography at Toulouse University Hospital for ST-segment elevation myocardial infarction with large culprit nonleft main coronary bifurcation lesion. Study participants were divided into 2 groups depending on the performance or not of a side branch intervention. We observed the living status at 1-year after hospital discharge. Side branch intervention by balloon inflation or final balloon kissing technique was performed in 34.1% of study participants. At 1-year follow-up, the incidence of all-cause mortality was 7.8 per 100 person-years (95% confidence interval [CI] 4.1 to 15), and although it seemed higher in the side branch intervention group (10 per 100 person-years [95% CI 3.8 to 26.7] vs 6.6 per 100 persons-years [95% CI 2.8 to 15.9]), the survival analyses showed no differences in survival outcomes (hazard ratio side branch intervention 1.55 [0.42 to 5.78], p=0.513). In conclusion, in the setting of a coronary bifurcation causing ST-segment elevation myocardial infarction, simple provisional stenting without side branch intervention showed a low mortality rate and no differences in the 1-year survival outcomes.

Comparing Outcomes of 45 Xen Implantation Ab Interno With Closed Conjunctiva to Ab Externo With Open Conjunctiva Approaches.

Ab externo with open conjunctiva placement may lead to improved gelatin stent (XEN Gel Stent; Allergan) success rate compared with ab interno with closed conjunctiva because it conferred more favorable intraocular pressure (IOP) and medication burden reduction based on our complete and qualified success criteria. To compare outcomes of a gelatin stent (XEN 45 Gel Stent; Allergan) placed either ab interno with closed conjunctiva (AIC) or ab externo with open conjunctiva (AEO) with or without cataract surgery in patients with glaucoma. Retrospective, nonrandomized comparative study of 85 eyes from 85 glaucoma patients who received XEN 45 Gel Stent placed either AIC (N=32) or AEO (N=53) with or without cataract surgery between July 2018 and January 2022 at Massachusetts Eye and Ear. Patients were included if they were 18 years of age or above and had at least 30 days of follow-up without any disqualifying event. Baseline demographics were similar between both groups, except for the glaucoma type. Both AIC and AEO procedures resulted in significant patterns of IOP and medication reduction from baseline up to 1 year. At postoperative year (POY)1, mean IOP was reduced to 11.34±4mmHg on 1.29±1.34 medications after AEO and 13.70±3.32mmHg on 2±1.81 medications after AIC. The average IOP reduction was significantly greater in the AEO group at all postoperative time points beyond postoperative week 2. There were significant differences in the survival curves of AEO and AIC groups under both the complete success criteria and the qualified success criteria. Under the complete success criteria, the cumulative probability of survival at POY1 was 28.5% in the AEO group and 3.8% in the AIC group. Under the qualified success criteria, the cumulative probability of survival at POY1 was 60.3% in the AEO group and 21.9% in the AIC group. In our study, we demonstrate that both placements reduce IOP and medication from baseline, with AEO placement having more favorable success rates compared with AIC placement.

Patients with Prior Exposure to a Combination of Statins & Angiotensin-Converting Enzyme Inhibitors (ACE-Is)/Angiotensin Receptor Blockers (ARBs) Have Better Outcomes after Carotid Revascularization than Patients with Prior Exposure to Statins Alone: A MultiCenter Analysis

Statin use has been studied and confirmed to have a beneficial impact on perioperative carotid endarterectomy (CEA) and carotid artery stenting (CAS) outcomes. The benefits of Angiotensin-converting enzyme inhibitors (ACE-I) in hypertension, ischemic heart disease, heart failure, diabetes mellitus, and renal disease are well-known; however, the impact of continuing or withholding ACE-Is/angiotensin receptor blockers (ARBs) on CEA and CAS outcomes is not addressed well in the literature. This study aimed to evaluate the impact of preoperative statin use combined with ACE-Is/ARBs in patients undergoing CEA or CAS on mortality and morbidity using a multi-institutional database. Using the data of all patients who underwent carotid artery revascularization, including CEA, transcarotid artery revascularization, and transfemoral carotid artery stenting from 2016 to 2021 in the Vascular Quality Initiative data, we determined as our primary outcome 30-day mortality/stroke after carotid revascularization based on periop exposure to statins alone, or the combination of statins and ACE-Is/ARBs. Secondary outcomes were postop myocardial infarction and postop congestive heart failure. Poisson regression with robust variance was used to determine postop outcomes comparing the combination of statin and ACE-Is/ARBs group with statins alone group. A total of 131,285 patients were included in the study, with 59,860 (46%) patients receiving statin only, and 71,425 (54%) receiving both statin and ACE-Is/ARBs preoperatively. Both patient groups differed significantly in preop clinical and demographic characteristics. After adjusting for potential confounders, the statins plus ACE-I/ARB group had a 12% lower risk of postop mortality/stroke (Incident Rate Ratio comparing Statin/ACE group to Statins Only group [IRR] 0.88, 95% confidence interval 0.81-0.95, P=0.001), 18% lower risk of postop congestive heart failure (IRR 0.82, 95% CI 0.68-0.98, P=0.029), and similar risk of postop myocardial infarction (IRR 1.05 95% confidence interval 0.91-1.20, P=0.54) compared to the statin-only group. Statins combined with ACE-Is/ARBs perioperatively offer better protection compared to statins alone in patients undergoing carotid revascularization surgery. We recommend the continuation of ACE-Is/ARBs use in patients undergoing carotid revascularization, especially if they have concurrent hypertension. Further prospective studies are needed to evaluate the benefit of adding ACE-Is/ARBs.

Unlocking Promising Therapies: Drug-Eluting Stents in Medically Refractory Angina Patients With Myocardial Bridging

Myocardial bridging (MB) is a congenital variation in which a coronary artery segment tunnels through the myocardium instead of following its usual epicardial route. Although MB is usually diagnosed incidentally and has a good long-term prognosis, it can lead to complications such as angina, myocardial infarction, arrhythmias, and sudden death. This study aimed to evaluate the outcomes of drug-eluting stent (DES) implantation in patients with MB and medically refractory angina. The study included 12 patients with significant MB who did not respond to maximal medical therapy and underwent DES implantation. The patients were followed up for a mean duration of 33months. The procedural success rate was 92%, with only 1 patient experiencing acute coronary artery rupture during the procedure. During the follow-up period, none of the patients reported angina symptoms, required additional percutaneous coronary intervention, or developed stent thrombosis. One patient (8.3%) died from a non-cardiac cause. The procedure demonstrates a high procedural success rate and leads to favorable long-term outcomes, including the absence of angina symptoms and the avoidance of stent-related complications. In conclusion, this study suggests that DES implantation can serve as an effective treatment option for selected patients with medically refractory angina and significant MB.

Five-Year Outcomes of Single Trabecular Microbypass Stent (iStent®) Implantation with Phacoemulsification in Korean Patients.

This study reports the long-term intraocular pressure (IOP)-lowering efficacy and safety of a singletrabecular microbypass stent(iStent®; Glaukos Corp., San Clemente, CA, USA) for medically controlled open-angleglaucoma in Korean patients. This retrospective observational study included 42 eyes of 35 patients with primary open-angle glaucoma (POAG). All subjects underwent single first-generation iStent® implantation with phacoemulsification by a single surgeon with 5years follow-up. The primary outcomes were changes in IOP and the number of antiglaucoma medications compared to the preoperative values. The secondary outcome was the proportion of eyes with IOP ≤ 18mmHg without medication, ≤ 15mmHg without medication, and ≤ 18mmHg with or without medication. Adverse events and need for secondary glaucoma surgery were also recorded. The mean IOP decreased from 15.8 ± 2.8 to 13.8 ± 1.7mmHg and the mean number of medications was reduced from 2.24 ± 1.18 to 0.83 ± 1.12, respectively, at year5. At 3 and 5years, 80.6% and 78.6% of eyes, respectively, were receiving fewer medications than preoperative numbers. In contrast, only 50% of eyes on four preoperative medications showed medication reductions at 5years. At years3 and 5, 61.3% and 53.5% of eyes achieved IOP ≤ 18mmHg without medication, whereas 90.3% and 89.3% of eyes achieved ≤ 18mmHg regardless of medication use, respectively. Four eyes required additional glaucoma surgery (two Ahmed glaucoma valve implantations, one trabeculectomy, and one XEN45 Gel Stent implantation), and all were receiving four preoperative antiglaucoma medications. Transient IOP elevation (14.3%) was the most common complication, followed by five hyphema, one stent obstruction, one stent malposition, and one severe anterior chamber reaction. This study demonstrated a good safety profile and sustained IOP reduction after the implantation of a single trabecular microbypass stent (iStent®) with phacoemulsification in Korean patients. The majority of subjects with POAG showed a relatively good response; however, eyes receiving a higher number of medications preoperatively (especially four medications) had difficulty achieving a low target IOP.

Clinical outcomes of a balloon-expandable stent for symptomatic obstructions of the subclavian or innominate arteries.

Background: Upper-extremity peripheral arterial disease (PAD) may present with a broad spectrum of signs and symptoms. If an endovascular treatment is planned, percutaneous angioplasty and stent placement may lead to a better patency compared to percutaneous angioplasty alone. We assessed the characteristics and clinical course of patients with upper-extremity PAD who received angioplasty and a balloon-expandable stent. Patients and methods: We analyzed data from consecutive patients treated with angioplasty and placement of a balloon-expandable BeSmooth Peripheral Stent System® (Bentley, Germany) at the Angiology Department (University Hospital Zurich) between 2018 and 2022. The primary outcome was re-intervention at the target lesion within 6 months from index angioplasty and during available follow-up. The study was approved by the local ethical commission. Results: A total of 27 patients were treated. The median age was 70 (Q1-Q3: 60-74) years and 59% were men. The subclavian artery (74%) represented the most frequently treated target lesion, followed by the innominate artery (26%). The mean improvement in blood pressure in the treated arm was 21 (95%CI 7 to 35) mmHg at 24 hours and 29 (95%CI 15 to 43) mmHg at 6 months. At 6 months, 2 (8%) patients required a target lesion re-intervention. During the remaining follow-up period up to 24 months, one of these two patients required additional intervention and a total of 3 (11%) patients died due to sepsis, cancer, and unknown causes, respectively. Conclusions: Percutaneous catheter-based treatment with a balloon-expandable stent for symptomatic upper extremity PAD appeared to be effective and safe.

Real-life Indications and Outcome of Electrocautery-enhanced Lumen-apposing Metal Stents in a Tertiary Center.

Electrocautery-enhanced lumen-apposing stents (EC-LAMS) were originally designed for the drainage of the gallbladder, bile duct, and pancreas pseudocysts. Throughout the years, several off-label indications were established. This study aims to evaluate the indication, safety, efficacy, and outcome of all LAMS implanted in a single tertiary referral center. From April 2016 to April 2022, all patients undergoing LAMS placement in a single tertiary center were included. We present a detailed analysis of indications, success rates, and complications based on a retrospective analysis of our prospectively maintained database. A total of 86 stents were placed in 77 patients between April 2016 and April 2022. Indications were walled-off pancreatic necrosis (25.6%), bile duct obstructions (16.3%), acute cholecystitis (15.1%), pancreas pseudocysts (15.1%), postoperative collections (10.5%), postoperative pancreatic fistulas (9.3%), and gastro-gastrostomy/jejunostomy (8.1%) to enable to perform an endoscopic retrograde cholangiopancreatography in patients with gastric bypass. Technical success was 97.7% (84 out of 86). A total of 10 (11.7%) adverse events were observed. In 3 patients (3.5%), severe complications occurred, which required acute surgery; one displacement was closed through clips. In 7 patients (8.2%), bleedings occurred during necrosectomy or from mucosal erosions at the stent side, respectively, that were treated with endoclips. EC-LAMS are safe and show a high technical success rate in all indications. In everyday clinical practice, the main indications are hepato-pancreato-biliary, and therefore an hepato-pancreato-biliary-surgical department should have EC-LAMS in their armamentarium.

Clinical outcomes of percutaneous Fontan stenting in adults.

Fontan pathway stenosis is a well-known complication post-palliation. Percutaneous stenting is effective for angiographic/hemodynamic relief of Fontan obstruction, but its clinical impact in adults remains unknown. Retrospective cohort of 26 adults undergoing percutaneous stenting for Fontan obstruction between 2014 and 2022. Procedural details, functional capacity, and liver parameters were reviewed at baseline and during follow-up. Age was 22.5 (19; 28.8) years; 69% were male. Post-stenting, Fontan gradient significantly decreased [1.5±1.7 vs 0 (0; 1) mmHg, p<0.005], and minimal Fontan diameter increased [11.3±2.9 vs 19.3 (17; 20) mm, p<0.001]. One patient developed acute kidney injury periprocedurally. During a follow-up of 2.1 (0.6; 3.7) years, one patient had thrombosis of the Fontan stent, and two underwent elective Fontan re-stenting. New York Heart Association functional class improved in 50% of symptomatic patients. Changes in functional aerobic capacity on exercise testing were directly related to pre-stenting Fontan gradient (n=7; r=0.80, p=0.03) and inversely related to pre-stenting minimal Fontan diameter (r=-0.79, p=0.02). Thrombocytopenia (platelet count <150 109/L) was present in 42.3% of patients pre- and 32% post-procedure (p=0.08), and splenomegaly (spleen size >13 cm) in 58.3% and 58.8% (p=0.57), respectively. Liver fibrosis (aspartate aminotransferase to platelet ratio index and Fibrosis-4) scores were unchanged post-procedurally compared to baseline. Percutaneous stenting in adults is safe and effective in relieving Fontan obstruction, resulting in subjective improvement in functional capacity in some. A subset of patients demonstrated improvement in markers of portal hypertension, suggesting that Fontan stenting could improve FALD in select individuals.

Outcome of both-bare type nitinol metal stents in distal biliary malignant obstruction: A post-market clinical follow-up study

BACKGROUND&#x0D; Neoplastic stenosis of the distal biliary (DBS) tract is not rare and the most common treatment is an endoscopic stent placement. Partially covered self-expandable metal stents (PC-SEMS) have been recently introduced and preliminary data are controversial in terms of lower stent ingrowth compared to uncovered self-expandable metal stents (SEMS) at expense of higher risk of migration.&#x0D; &#x0D; AIM&#x0D; To confirm the safety and/or clinical performance of partially covered nitinol metal stents (Niti-S- Taewoong Medical Co. Ltd., Korea) in DBS management.&#x0D; &#x0D; METHODS&#x0D; This is a post-market clinical follow-up study which analyzed all consecutive patients from March 2021 to April 2022 who underwent PC-SEMSs [Niti-S Biliary Covered stent (Both Bare Type) - Taewoong Medical Co. Ltd., Korea] placement for drainage of malignant DBS. The follow-up time was 6 mo. The safety of the device was evaluated by occurrence of procedure-related and stent-related adverse events.&#x0D; &#x0D; RESULTS&#x0D; Thirty patients (21 males, median age 75 years) were enrolled: at the time of the procedure 24 patients had pancreatic cancer, 67% of patients had, at the time of the procedure, an advanced inoperable disease. Technical success rate was achieved in 96.7% of patients, while clinical success after 3-6 wk was achieved in 95% of patients and all surviving patients achieved normal bilirubin levels within 10 wk from the procedure. One patient had a mild procedure-related adverse event, and one experienced a moderate stent-related adverse event. Stent occlusion rate was 6.6%: 2 patients had recurrent biliary obstruction endoscopically treated, while stent migration was never recorded.&#x0D; &#x0D; CONCLUSION&#x0D; This PMCF study demonstrates that Niti-S SEMS (Both Bare Type – Taewoong) provides adequate palliation, no migration and fair duration of patency comparable with the best results in reported series of SEMS placement for DBS treatment.

Antithrombotic management of patients with deep vein thrombosis and venous stents: an international registry

BackgroundIn patients with acute deep vein thrombosis (DVT) treated with catheter-based thrombolysis and venous stenting, poststenting anticoagulant management is uncertain. ObjectivesTo determine the type and duration of antithrombotic therapy used in patients who have received venous stents for treatment of acute lower extremity DVT. MethodsWe created an international registry of patients with leg DVT from 2005 to 2019 who received venous stents as part of their acute management. We collected data on baseline clinical characteristics and pre-venous and post-venous stent antithrombotic therapy. ResultsWe studied 173 patients with venous stents: 101 (58%) were aged ≤50 years, 105 (61%) were female, and 128 (74%) had risk factors for thrombotic disease. DVT was iliofemoral in 150 (87%) patients, and catheter-based treatment was given within 7 days of diagnosis in 92 (53%) patients. After venous stenting, 109 (63%) patients received anticoagulant-only therapy with a direct oral anticoagulant (29%), warfarin (22%), or low-molecular-weight heparin (10%), and 59 (34%) received anticoagulant-antiplatelet therapy. In patients taking anticoagulant-only therapy, 29% received indefinite treatment; in patients on anticoagulant-antiplatelet therapy, 19% received indefinite treatment. Factors associated with combined anticoagulant-antiplatelet therapy vs anticoagulant-only therapy were use of thrombolytic, thrombectomy, and aspiration interventions (odds ratio [OR], 5.11; 95% CI, 1.45-18.05); use of balloon angioplasty (OR, 2.62; 95% CI, 1.20-5.76); and immediate stent restenosis (OR, 7.2; 95% CI, 1.45-5.89). ConclusionAnticoagulant therapy without concomitant antiplatelet therapy appears to be the most common antithrombotic strategy in patients with DVT and venous stenting. More research is needed to determine outcomes of venous stenting in relation to antithrombotic therapy.

Outcome of the Endoscopic Biliary Stenting for Irretrievable Common Bile Duct Stones in an Academic Hospital – A Prospective Study

Background: Choledocholithiasis is characterized by the existence of a stone in the common bile duct. Based on findings published in the Medical Clinics of North America, around 10-15% of individuals with gallstones experience the development of choledocholithiasis. Presently, the established approach for addressing common bile duct stones involves the implementation of endoscopic papillotomy and stone extraction. The combined utilization of Dormia basket, balloon catheter, and lithotripsy achieves a success rate of approximately 90%. In cases where traditional endoscopic removal methods prove ineffective, biliary stenting plays a crucial role in the conservative management of CBD stones. Objectives: The main goal of the study was to evaluate the outcome of biliary stenting in irretrievable common bile duct stones. Materials and Methods: This observational study took place at the Department of Gastroenterology, Dhaka Medical College and Hospital, Dhaka, from January 2018 to December 2018. The study included consecutive patients who were 18 years or older and diagnosed with common bile duct stones. These patients underwent endoscopic retrograde cholangiopancreatography (ERCP) for stone extraction. The study specifically focused on patients who received biliary stenting for irretrievable common bile duct stones, and they were enrolled as participants in the study. Results: Out of the 83 patients who underwent endoscopic retrograde cholangiopancreatography (ERCP) for stone extraction, 29 patients (35%) were deemed as having irretrievable stones, necessitating the implementation of stenting. Among these irretrievable stone cases, the average age was 46.69, and there was a predominance of females with 17 patients (58.6%). Of the 29 cases, 22 patients completed the follow-up. During the follow-up ERCP, a significant reduction was observed in both the average number of stones (3.14 vs. 1.9; P=0.002) and their size (16.32 vs. 12.4; P=0.005). Successful stone extraction was achieved in 14 patients (63.64%) during the second ERCP. In one patient (4.55%), spontaneous clearance of the stone occurred, while in 7 patients (31.81%), stone extraction was not possible during the second ERCP. The reduction in mean stone size was the only significant factor affecting the success of the second ERCP. However, there was no correlation found between the duration of stenting and the reduction in stone size (r=-0.193, p=0.401). Conclusion: Our study shows that repeat ERCP can successfully extract stones regardless of stenting duration. Unlike Western data, we emphasize the effectiveness of endoscopic biliary stenting in a context with limited access to advanced techniques, where initial stone extraction rates are lower. This approach is particularly beneficial for patients with stone sizes over 15 mm, avoiding the need for complex surgical procedures.