How real can we get in generating real world evidence? Exploring the opportunities of routinely collected administrative data for evaluation of medical devices.

Real-world data are considered a potentially valuable source of evidence for assessing medical technologies in clinical practice, but their widespread use is hampered by numerous challenges. Using the case of coronary stents in Italy, we investigate the potential of administrative databases for estimating costs and health outcomes associated with the use of medical devices in real world conditions. An administrative dataset was created ad hoc by merging hospital records from patients admitted between 2013 and 2019 for stent implantations with ambulatory records, pharmaceutical use data and vital statistics. Health outcomes were multifold: all-cause and cardiac mortality and myocardial infarction, within 30 days, 1, 2, 5 years. Costs were estimated from the National Health System perspective. We used multivariable Cox models and propensity score (PS) methods (PS matching; stratification on PS; inverse probability of treatment weighting using PS; PS adjustment). 257,907 coronary stents were implanted in 113,912 patients. For all health outcomes and follow-up times, and across all methods, patients receiving drug-eluting stents (DES) presented lower risk. For all-cause mortality, the DES patient advantage over bare-metal stent (BMS) patients declined over time but remained significant even at 5 years. For myocardial infarction, results remained quite stable. The DES group presented lower cumulative total costs (ranging from 3264 to 2363 Euros less depending on methods). Our results confirm the consolidated evidence of the benefits of DES compared to BMS. The consistency of results across methods suggests internal validity of the study, while highlighting strengths and limitations of each depending on research context. Administrative data yield great potential to perform comparative effectiveness and cost-effectiveness analysis of medical devices provided certain conditions are met.

One-year outcome of single-stent crossover versus accurate ostial stenting for isolated left anterior descending ostial stenosis.

BACKGROUND: The optimal strategy of percutaneous coronary intervention (PCI) for isolated left anterior descending (LAD) ostial lesions remains debatable. This study aimed to compare clinical outcomes of patients with isolated LAD ostial stenosis treated by single-stent crossover versus accurate ostial stenting. METHODS: A total of 216 eligible consecutive patients with isolated de novo LAD ostial stenosis were enrolled, and were stratified according to the stenting techniques. Clinical follow-up was performed by review of medical charts or telephone contact with the patients, and repeat angiography was made at 9-12 months after the procedure. Major adverse cardiovascular events (MACE) including cardiac death, myocardial infarction, non-fatal stroke and target vessel revascularization (TVR) were recorded. RESULTS: Single-stent crossover and accurate ostial stenting were applied to 78 (36%) and 138 (64%) patients, respectively. During a mean of 13 ± 4.1 months of follow-up, the rate of composite MACE (19.6 vs. 8.9%; P = 0.040) was higher in LAD ostial stenosis patients treated with accurate ostial stenting than those treated with single-stent crossover technique, mainly driven by more frequent TVR (17.4 vs. 7.7%; P = 0.048). PCI strategy was an independent predictor of MACE (hazard ratio 2.561; 95% CI, 1.041-6.299; P = 0.021) in the multivariable Cox regression analysis. CONCLUSIONS: Our retrospective study suggests that the single-stent crossover technique is associated with a better 1-year clinical outcome compared with accurate ostial stenting in patients with isolated LAD ostial stenosis.

A retrospective study on the preventive effect of statin after carotid artery stenting.

ABSTRACT: This retrospective study appraised the preventive effect of statin after carotid artery stenting (CAS).Records were extracted for 100 patients with CAS surgery indicator, aged between 20 and 75 years old, and treated for statin. The cohort study included treatment group (statin and routine treatment) and control group (routine treatment), each group 50 patients. Outcomes consisted of degree of nerve defect (as measured by National Institute of Health Stroke Scale), lipid profiles (mg/dL), and CAS complications within 30 days after surgery.After treatment, there were no significant differences in National Institute of Health Stroke Scale, lipid profiles, and mortality rate between 2 groups. However, significant differences in total cholesterol (mg/dL, P = .03), low-density lipoprotein (mg/dL, P = .01), transient ischemic attack (P = .03), ischemic stroke (P = .04), and cardiac complications (P = .03) were identified within 30 days after CAS between 2 groups.The results of this study showed that prior statin treatment may be effective for the prevention of CAS complications.

Abbreviated Antiplatelet Therapy in Patients at High Bleeding Risk With or Without Oral Anticoagulant Therapy After Coronary Stenting: An Open-Label, Randomized, Controlled Trial.

BACKGROUND: The optimal duration of antiplatelet therapy (APT) in patients at high bleeding risk with or without oral anticoagulation (OAC) after coronary stenting remains unclear. METHODS: In the investigator-initiated, randomize, open-label MASTER DAPT trial (Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Standard DAPT Regimen), 4579 patients at high bleeding risk were randomized after 1-month dual APT to abbreviated or nonabbreviated APT strategies. Randomization was stratified by concomitant OAC indication. In this subgroup analysis, we report outcomes of populations with or without an OAC indication. In the population with an OAC indication, patients changed immediately to single APT for 5 months (abbreviated regimen) or continued ≥2 months of dual APT and single APT thereafter (nonabbreviated regimen). Patients without an OAC indication changed to single APT for 11 months (abbreviated regimen) or continued ≥5 months of dual APT and single APT thereafter (nonabbreviated regimen). Coprimary outcomes at 335 days after randomization were net adverse clinical outcomes (composite of all-cause death, myocardial infarction, stroke, and Bleeding Academic Research Consortium 3 or 5 bleeding events); major adverse cardiac and cerebral events (all-cause death, myocardial infarction, and stroke); and type 2, 3, or 5 Bleeding Academic Research Consortium bleeding. RESULTS: Net adverse clinical outcomes or major adverse cardiac and cerebral events did not differ with abbreviated versus nonabbreviated APT regimens in patients with OAC indication (n=1666; hazard ratio [HR], 0.83 [95% CI, 0.60-1.15]; and HR, 0.88 [95% CI, 0.60-1.30], respectively) or without OAC indication (n=2913; HR, 1.01 [95% CI, 0.77-1.33]; or HR, 1.06 [95% CI, 0.79-1.44]; Pinteraction=0.35 and 0.45, respectively). Bleeding Academic Research Consortium 2, 3, or 5 bleeding did not significantly differ in patients with OAC indication (HR, 0.83 [95% CI, 0.62-1.12]) but was lower with abbreviated APT in patients without OAC indication (HR, 0.55 [95% CI, 0.41-0.74]; Pinteraction=0.057). The difference in bleeding in patients without OAC indication was driven mainly by a reduction in Bleeding Academic Research Consortium 2 bleedings (HR, 0.48 [95% CI, 0.33-0.69]; Pinteraction=0.021). CONCLUSIONS: Rates of net adverse clinical outcomes and major adverse cardiac and cerebral events did not differ with abbreviated APT in patients with high bleeding risk with or without an OAC indication and resulted in lower bleeding rates in patients without an OAC indication. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03023020.

Comparison Between Lumen-Apposing Metal Stents and Plastic Stents in Endoscopic Ultrasound-Guided Drainage of Pancreatic Fluid Collection: A Meta-analysis and Systematic Review.

OBJECTIVES: This study aimed to explore efficacy and safety between LAMSs (lumen-apposing metal stents) and DPPSs (double-pigtail plastic stents) in endoscopic ultrasound-guided drainage for pancreatic fluid collections. METHODS: Electronic databases were searched to identify relevant studies published until July 20, 2020. RESULTS: Fifteen studies were identified in this study. Endoscopic ultrasound-guided drainage with LAMS has higher clinical success (90.01% vs 82.56%) (odds ratio [OR], 2.44; 95% confidence interval [CI], 1.79-3.33; P < 0.00001), less recurrence (OR, 0.44; 95% CI, 0.29-0.68; P = 0.0002), and fewer additional interventions (OR, 0.34; 95% CI, 0.211-0.55; P < 0.001). There was no significant difference between LAMS and DPPS in technical success (97.45% vs 97.38%) (OR, 0.92; 95% CI, 0.50-1.70; P = 0.80), adverse events (OR, 0.92; 95% CI, 0.41-2.09; P = 0.84), stent-related adverse events (OR, 0.78; 95% CI, 0.39-1.54; P = 0.47), and bleeding (OR, 1.47; 95% CI, 0.57-3.28; P = 0.42). Lumen-apposing metal stents have slightly more perforations (OR, 7.10; 95% CI, 1.22-41.30; P = 0.03) in studies of walled-off necrosis. CONCLUSIONS: Lumen-apposing metal stents have the advantage of higher clinical success, less recurrence, and fewer additional interventions. However, LAMS may increase perforation for walled-off necrosis.

Comparison the effects of carotid endarterectomy with carotid artery stenting for contralateral carotid occlusion.

BACKGROUND: There have been inconsistent results regarding the use of carotid artery endarterectomy (CEA) versus carotid artery stenting (CAS) for contralateral carotid occlusion (CCO). This study aimed to determine the optimal revascularization technique for patients with CCO. METHODS: We systematically searched the PubMed, Embase, and Cochrane Library databases to identify eligible studies published from inception to January 2, 2021. Odds ratios (ORs) with 95% confidence intervals (CIs) were used to calculate pooled effect estimates using a random-effects model. Sensitivity, subgroup, and publication bias analyses were also performed. RESULTS: Six studies involving 6,953 patients were selected for inclusion in this meta-analysis. Our results showed that while CEA was not associated with an increased risk of stroke compared to CAS (OR: 1.07; 95% CI: 0.75-1.51; P = 0.713), CEA was associated with a reduced risk of death compared to CAS (OR: 0.45; 95% CI: 0.29-0.70; P < 0.001). Furthermore, there were no significant differences between CEA and CAS for the risks of myocardial infarction (OR: 1.38; 95% CI: 0.73-2.62; P = 0.319) or major adverse cardiovascular events (OR: 1.03; 95% CI: 0.56-1.88; P = 0.926). Finally, the risk of myocardial infarction for CEA versus CAS was affected by disease status, while the risk of major adverse cardiovascular events was affected by the proportions of patients with male gender, coronary artery disease, and current or prior smoking. CONCLUSION: This study found that CEA and CAS resulted in similar outcomes for patients with CCO, while the risk of death was reduced in patients treated with CEA. Further high-level evidence should be collected to verify the results of this study.

Covered vs bare stent for distal malignant biliary obstruction due to primary common biliary cancer.

ABSTRACT: This study was designed as a means of comparing the clinical efficacy and long-term outcomes of covered vs bare stent insertion as a treatment for distal malignant biliary obstruction (DMBO) caused by primary common biliary cancer (PCBC).This retrospective study was designed using data collected between January 2012 and December 2019 to assess the short- and long-term outcomes in patients with DMBO caused by PCBC treated by inserting either bare or covered stents were compared.Ninety two patients with DMBO caused by PCBC were divided between bare (n = 51) or covered (n = 41) stent groups. Technical success rates in both groups were 100%. Clinical success of bare vs covered stent use were 96.1% and 97.6% (P = 1.00). Stent dysfunction was seen in 17 and 6 patients in the bare and covered stent groups, respectively (P = .04). The median stent patency for bare and covered stents was 177 and 195 days, respectively (P = .51). The median survival was 188 and 200 days in the bare and covered stent groups, respectively (P = .85).For patients with DMBO caused by PCBC, using bare vs covered stents yields similar clinical efficacy and long term outcomes.

Comparative evaluation of ballet-type and conventional stent graft configurations for endovascular aneurysm repair: A CFD analysis.

PURPOSE: Cross limb stent graft (SG) configuration technique for endovascular aneurysm repair (EVAR) is employed for splayed aortic bifurcations to avoid device kinking and smoothen cannulation. The present study investigates three types of stent graft (SG) configurations for endovascular aneurysm repair (EVAR) in abdominal aortic aneurysm. A computational fluid dynamic analysis was performed on the pulsatile non-Newtonian flow characteristics in three ideally modeled geometries of abdominal aortic (AA) SG configurations. METHODS: The three planar and crosslimb SG configurations were ideally modeled, namely, top-down nonballet-type, top-down ballet-type, and bottom-up nonballet-type configurations. In top-down SG configuration, most of the device is deployed in the main body in the vicinity of renal artery and the limbs are extended to the iliac artery. While in the bottom-up configuration, some of the SG device is deployed in the main body, the limbs are deployed in aortic bifurcation, and the extra stent graft of the main body is extended to the proximal aorta until the below of the renal artery. The effects of non-Newtonian pulsatile flow on the wall stresses and flow patterns of the three models were investigated and compared. Moreover, the average wall shear stress (AWSS), oscillatory shear stress index (OSI), absolute helicity, pressure distribution, graft displacement and flow visualization plots were analyzed. RESULTS: The top-down ballet-type showed less branch blockage effect than the top-down nonballet-type models. Furthermore, the top-down ballet-type configuration showed an increased tendency to sustain high WSS and higher helicity characteristics than that of the bottom-up and top-down non-ballet type configurations. However, displacement forces of the top-down ballet-type configuration were 40% and 9.6% higher than those of the bottom-up and top-down nonballet-type configurations, respectively. CONCLUSIONS: Some complications such as graft tearing, thrombus formation, limb disconnection during long term follow up periods might be relevant to hemodynamic characteristics according to the configurations of EVAR. Hence, the reported data required to be validated with the clinical results.

Esophageal metal stent for malignant obstruction after prior radiotherapy.

The association between severe adverse events (SAEs) and prior radiotherapy or stent type remains controversial. Patients with esophageal or esophagogastric junctional cancer who underwent stent placement (2005-2019) were enrolled in this retrospective study conducted at a tertiary cancer institute in Japan. The exclusion criteria were follow-up period of < 1 month and insufficient data on stent type or cancer characteristics. We used Mann-Whitney's U test for quantitative data and Fisher's exact test for categorical data. Multivariate analysis was performed using a logistic regression model. 107 stents were placed. Low radial-force stents (L group) were used in 51 procedures and high radial-force stents (H group) in 56 procedures. SAEs developed after nine procedures, the median interval from stent placement being 6 days (range, 1-141 days). SAEs occurred more frequently in the H (14%: 8/56) than in the L group (2%: 1/51) (P = 0.03). In patients who had undergone prior radiotherapy, SAEs were more frequent in the H (36%: 4/11) than in the L group (0%: 0/13) (P = 0.03). Re-obstruction and migration occurred after 16 and three procedures, respectively; these rates did not differ significantly between groups (P = 0.59, P = 1, respectively). Low radial-force stents may reduce the risk of SAEs after esophageal stenting.

Efficiency of Percutaneous Stent Angioplasty in Renal Artery Stenosis - 15 Years of Experience at a Single Center.

PURPOSE: To determine the therapeutic efficiency of percutaneous revascularization in renal artery stenosis (RAS), as well as the role of comprehensive factors such as patient selection and degree of artery stenosis, on clinical outcome. METHODS AND MATERIALS: 101 patients with hemodynamically relevant RAS underwent percutaneous angioplasty (PTA). 65.7 % were male (mean age: 64 years; range: 18-84). The clinical data was retrospectively analyzed. The serum creatinine (Cr), glomerular filtration rate (GFR), and blood pressure (BP) levels pre- and postprocedural, between 6 months and 1 year, were retrospectively collected and statistically analyzed. RESULTS: Follow-up data was available in 34 (33.7 %) and 28 patients (27.7 %) for Cr and MAP, respectively. A significant drop in mean arterial pressure (MAP) was observed on follow-up (mean -5.27 mmHg). Higher baseline Cr and MAP values showed a more pronounced drop in the follow-up (Cr: p 0.002; difference to baseline -0.25 mg/dL, 95 %CI:-0.36, -0.07 and BP p < 0.001; diff. to baseline -0.72 mmHg; 95 %CI: -1.4, -0.40). There was no association between comorbidities, gender, and degree of stenosis with renal and BP outcome. No significant improvement in renal function was observed on follow-up (mean Cr drop: -0.015 mg/dL). The age group 51-60 years showed a significant improvement in BP (p 0.030; diff. to baseline -19.2 mmHg; 95 %CI: -34, -4.3). There was a slight reduction in antihypertensive medication following angioplasty (0.2 fewer). Minor complications were recorded in five procedures (4.9 %). CONCLUSION: Percutaneous renal artery revascularization in the presence of atherosclerotic RAS is a safe procedure associated with a significant drop in post-procedural BP. No significant improvement in renal function was observed. Further prospective studies focused on patient selection are necessary. KEY POINTS: · Percutaneous stent angioplasty in renal artery stenosis is associated with a significant improvement in post-procedural blood pressure control.. · There is no improvement in renal function after percutaneous stent angioplasty for renal artery stenosis (RAS).. · Percutaneous stent angioplasty is a safe procedure.. CITATION FORMAT: · Guerreiro H, Avanesov M, Dinnies S et al. Efficiency of Percutaneous Stent Angioplasty in Renal Artery Stenosis - 15 Years of Experience at a Single Center. Fortschr Röntgenstr 2021; 193: 298 - 304.

XEN® Gel Stent compared to PRESERFLO™ MicroShunt implantation for primary open-angle glaucoma: two-year results.

PURPOSE: To evaluate the long-term efficacy and safety of two minimally invasive glaucoma surgery implants with a subconjunctival drainage approach: the XEN45 Gel Stent® (Xen) implant and the PRESERFLO™ MicroShunt (MicroShunt). METHODS: Retrospective comparative case series of primary open-angle glaucoma (POAG) patients with at least 6 months of follow-up after a MicroShunt or Xen implantation augmented with mitomycin C. RESULTS: Forty-one eyes of 31 patients underwent Xen implantation, and 41 eyes of 33 patients, MicroShunt implantation. Baseline characteristics were similar, except for more combined surgeries with phacoemulsification in the Xen group (37% vs. 2%). Mean baseline IOP ± standard deviation dropped from 19.2 ± 4.4 to 13.8 ± 3.8 mmHg (n = 26) in the Xen group and from 20.1 ± 5.0 to 12.1 ± 3.5 (n = 14) in the MicroShunt group at 24 months of follow-up (p = 0.19, t-test). The number of IOP-lowering medications dropped from 2.5 ± 1.4 to 0.9 ± 1.2 in the Xen group and from 2.3 ± 1.5 to 0.7 ± 1.1 in the MicroShunt group. The probability of qualified success was 73% and 79% at 24 months of follow-up for the Xen and MicroShunt groups, respectively. Postoperative complications were usually mild and self-limiting. The number of bleb needling and secondary glaucoma surgery procedures was similar in both groups; however, in the Xen group more additional MicroPulse® transscleral cyclophotocoagulation procedures were performed. CONCLUSION: Xen Gel Stent and PreserFlo MicroShunt implantations achieved comparable results in POAG eyes in terms of IOP-lowering and surgical success, with a similar high safety profile.

Flow-diverting stent and delayed intracranial bleeding: the case for discussing acquired von Willebrand disease.

A unique feature of the flow-diverting stent (FDS) has rendered it useful in the endovascular treatment of selected intracranial aneurysms for the last decade. Delayed aneurysmal rupture and intracranial parenchymal bleeding are two leading hemorrhagic complications after FDS. It has recently been shown for the first time that there is a relationship between FDS and reduced level of vWF activity in patients undergoing endovascular cerebral aneurysm treatment. Here, the current literature is reviewed in the context of this novel finding to propose an illustrative scenario that conceptually links implantation of FDS to delayed intracranial bleeding, through the mechanism of shear-induced activation of vWF. In this scenario, after FDS implantation, sustained release of activated vWF in association with platelets plays a pivotal role in the mechanisms of delayed intracranial hemorrhages.

Placement of self-expanding metallic tracheobronchial Y stent with laryngeal mask airway using conscious sedation under fluoroscopic guidance.

BACKGROUND: Central airway obstruction and fistula are treated with a tracheobronchial Y stent. In the currently used self-expandable metal Y stents, the delivery system is 8 mm in diameter and requires either a 9 mm tracheal tube or rigid bronchoscope to enable airway control during insertion. In this study we present a novel technique of laryngeal mask airway (LMA) assisted Y stent insertion, enabling airway control during deployment of the Y stent. METHODS: All procedures using LMA in assisting Y stent insertions between 2014-2020 were reviewed. Data collected included demographics, clinical diagnosis and disease characteristics, indication, procedural success rates, clinical outcome and survival. RESULTS: A total of 10 patients with a median age of 61.5 years (range 37-73) underwent LMA assisted Y stent insertion. Indications for stent insertion were malignant disease with central airway obstruction or fistula. In all cases airway patency was achieved leading to improvement of symptoms and performance status. No procedural complications were reported. The median survival was 4.5 weeks (range: 2-26). CONCLUSIONS: LMA assisted Y stent insertion enables airway control during the procedure. In comparison to silicone Y stent insertion, the procedure is less cumbersome, shorter in duration and does not require the use of general anesthesia or rigid bronchoscopy. KEY POINTS: SIGNIFICANT FINDINGS OF THE STUDY: LMA assisted Y stent insertion enables airway control during the implantation of metallic self-expanding Y stent. The procedure does not require the use of general anesthesia or rigid bronchoscopy. WHAT THIS STUDY ADDS: In this study we present the technique and outcomes of LMA assisted Y stent insertion. This method of Y stent insertion provides an additional treatment option for patients with central airway obstruction and fistula.

Tratamiento intervencionista con stents en recién nacidos con cardiopatías congénitas complejas / Interventionist treatment with stents in newborns with complex congenital heart disease

Introducción: La colocación de stents mediante cateterismo cardiaco en recién nacidos con ciertas cardiopatías congénitas complejas constituye un puente hacia la cirugía correctiva, paliativa o trasplante cardiaco. Objetivo: Evaluar el resultado del implante percutáneo de stents en pacientes recién nacidos con cardiopatías congénitas complejas. Presentación de los casos: Se colocó stents en cinco pacientes; a uno de ellos en la aorta y a los cuatros restantes en el ductus arterioso. Un primer paciente con hipoplasia de cavidades izquierdas en el que predominaba el bajo gasto se le colocó stent en el ductus e inmediatamente se le condujo al salón de operaciones para cerclaje pulmonar. Otro paciente con la misma enfermedad, pero en el que predominaba el hiperflujo pulmonar, se intervino de forma inversa, medió 47 días entre uno y otro proceder. A un tercer paciente, portador de coartación aórtica, se le colocó stent en la aorta y se le hizo cerclaje pulmonar 14 días después del proceder hemodinámico. Las condiciones clínicas del cuarto paciente, con síndrome de hipoplasia de cavidades izquierdas solo permitió colocar stent en el ductus. Esta paciente fallece en evento no relacionado con el cateterismo cardiaco. El último paciente intervenido, portador de una atresia pulmonar, tolera la colocación del stent en el ductus y la evolución clínica posterior demostró que no requería realizar cerclaje pulmonar. Conclusiones: La colocación de stent en el grupo de pacientes analizado es factible y el momento de su implante según el evento hemodinámico apremiante pudiera ser una forma alternativa del cateterismo cardiaco(AU)

Introduction: The paliative placing of stents by cardiac catetherism in new borns with specific congenital hearts diseases is a bridge through a new kind of corrective, paliative surgery or heart transplant. Objective: To evaluate the result of the percutaneous implant of stents in newborn patients with complex congenital heart diseases. Cases presentation: There were placed stents in 5 patients, to one of them in the aorta and to the other four in the ductus arteriosus. The first patient with hypoplasia of the left cavities in which low output predominated had an stent placing in the ductus and he was immediately taken to OR to perform a pulmonary cerclage. Another patients with the same disease but with predominance of pulmonary hyperflow was intervened in the inverse way; there were 47 days between both procedures. A third patient, carrier of aortic coarctation, had an stent placing in the aorta and he also had pulmonary cerclage 14 days after the hemodynamic procedure. The clinical conditions of the fourth patient, who had syndrome of left cavities´ hypoplasia, just allowed to place the stent in the ductus. This patients died in a procedure not related to heart catetherism. The last intervened patient, who was a carrier of pulmonary atresia, tolerated the stent placing in the ductus and the subsequent clinical evolution showed that it was not needed pulmonary cerclage. Conclusions: The stent placing in the analized group of patients is suitable and the moment for its implantation according to the hemodynamic event can be an alternative form of heart catetherism(AU)

Clinical Outcomes of Complications Following Self-Expandable Metallic Stent Insertion for Benign Tracheobronchial Stenosis.

Background and Objectives: The use of metallic stents in benign TBS is controversial. Here, we report the clinical outcomes of patients who developed complications due to self-expandable metallic stent (SEMS) insertion for benign TBS. Materials and Methods: Our institution, which is the largest and most active referral hospital for airway stenosis in South Korea, only uses silicone stents. We conducted a retrospective review of 20 patients referred after the insertion of SEMS for benign TBS from 2006 to 2015. Results: All 20 patients underwent rigid bronchoscopy for SEMS removal due to airway obstruction from granulation tissue overgrowth. All but one (95%) experienced successful removal of the SEMS. During a median follow-up period of 40 months, a median of seven rigid bronchoscopies per patient was needed to maintain airway patency. Three (15%) patients suffered acute complications during SEMS removal (bleeding (10%) and fistula (5%)). All patients suffered chronic complications (granulation tissue (80%), stent migration (58%), mucostasis (55%), and restenosis (43%)). Eventually, 15 patients (75%) needed airway prostheses (silicone stent (75%) and tracheostomy (25%)). Conclusion: Our findings indicate that SEMS should be avoided until positive results are consistently reported by high-quality studies in patients with benign TBS.

Endoscopic ultrasound (EUS) and the management of pancreatic cancer.

Pancreatic cancer is one of the leading causes of cancer-related mortality in western countries. Early diagnosis of pancreatic cancers plays a key role in the management by identification of patients who are surgical candidates. The advancement in the radiological imaging and interventional endoscopy (including endoscopic ultrasound (EUS), endoscopic retrograde cholangiopancreatography and endoscopic enteral stenting techniques) has a significant impact in the diagnostic evaluation, staging and treatment of pancreatic cancer. The multidisciplinary involvement of radiology, gastroenterology, medical oncology and surgical oncology is central to the management of patients with pancreatic cancers. This review aims to highlight the diagnostic and therapeutic role of EUS in the management of patients with pancreatic malignancy, especially pancreatic ductal adenocarcinoma.

Histological and Mechanical Behavior of INC 01 and 02 Bare Metal Stents Against a Commercial Stent: A Preclinical Study in a Porcine Model.

BACKGROUND: PCI is an expensive procedure in our population and it implies a huge cost for the institutions and National Health Service. AIM OF THE STUDY: The main objective was to evaluate the technical and biological success of two stents designed in Mexico. METHODS: Ten York pigs, 4-6 months of age, underwent implantation of the bare metal INC-01 (10 stents) and INC-02 (6 stents) coronary stent in addition to a conventional commercial stent (10 stents). Technical success was evaluated immediately with angiography and Intravascular Ultrasound IVUS, continued by a mean follow-up of 4 month and a final angiographic, IVUS and histological evaluation. RESULTS: Initial technical success, angiography and IVUS between the three stents were not significant. One stent presented restenosis in follow-up (commercial stent), but all other stents presented excellent clinical outcome, satisfactory angiographic and IVUS results. Inflammation, proliferation and endothelialization between the stents had no major differences in histological analysis in a mean of 4 months follow-up. CONCLUSIONS: In this pig model, the INC 01 and INC 02 stents showed the same delivering technical success, angiographic and IVUS features, biological and histological response compared to commercial last generation stents.

Bifurcation Aneurysm Treatment with PulseRider: Technical Nuances, Device Selection, Positioning Strategies, and Overcoming Geometric Challenges.

BACKGROUND: Endovascular therapy is a viable alternative to surgical clipping for the treatment of intracranial aneurysms; however, aneurysms arising at bifurcations remain a challenge. The purpose of this technical report is to share the nuances of treating aneurysms with the PulseRider (PR), including device selection and positioning strategy, from authors who are highly experienced in its use. METHODS: We offer a comprehensive guide for neuroendovascular surgeons less experienced with PR applications to include design, general coil embolization technique, principles of deployment and detachment, positioning options, and geometric challenges and their solutions. RESULTS: In our experience, the PR is well suited for addressing the challenges of treating bifurcation aneurysms. CONCLUSIONS: PR use is intuitive and straightforward for use in bifurcation aneurysms with ideal favorable. PR can also be safely and effectively used to address a much broader and more challenging range of geometries.