Degrees of Inflammation in the Treatment of Subglottic Stenosis in a Rabbit Model: Histopathological Assessment of a Novel Bioabsorbable Ultra-high Ductility Magnesium Alloy Stent.

OBJECTIVE: Utilizing a novel histopathological scoring system and subglottic stenosis (SGS) rabbit model, we aimed to compare degrees of inflammation and severity of narrowing in the subglottis between two minimally invasive therapeutic modalities: endoscopic balloon dilation (EBD) alone versus EBD with placement of a bioabsorbable ultra-high ductility magnesium (UHD-Mg) alloy stent. METHODS: SGS was induced endoscopically via microsuspension laryngoscopy in 23 New Zealand white rabbits. The control group (n = 11) underwent EBD alone, the study arm (n = 12) underwent EBD with implantation of bioabsorbable UHD-Mg alloy stents. Rabbits were euthanized at 2-, 3-, and 6-weeks after SGS induction, coinciding with wound healing stages. Using Optical Coherence Tomography (OCT), cross-sectional areas of airways were compared to calculate the mean percentage of intraluminal area at sequential time points. A novel histopathological scoring system was used to analyze frozen sections of laryngotracheal complexes. The degree of inflammation was quantified by scoring changes in inflammatory cell infiltration, epithelial ulceration/metaplasia, subepithelial edema/fibrosis, and capillary number/dilation. Univariate analysis was utilized to analyze these markers. RESULTS: We found rabbits implanted with the bioabsorbable UHD-Mg alloy stent had statistically significantly higher scores in categories of hyperplastic change (stents vs controls: 1.48 vs 0.46 p < 0.001), squamous metaplasia (22 vs 5 p < 0.001), and neutrophils/fibrin in lumen (31 vs 8, p < 0.001). Rabbits who received EBD alone had higher scores of subepithelial edema and fibrosis (2.70 vs 3.49, p < 0.0256). The stented rabbits demonstrated significantly increased mean percent stenosis by intraluminal mean area compared to controls at 2 weeks (88.56 vs 58.98, p = 0.032), however at all other time points there was no significant difference between intraluminal subglottic stenosis by mean percent stenosis area. DISCUSSION: Rabbits with SGS treated with UHD-Mg alloy stents demonstrated histopathologic findings suggestive of lower levels of tracheal fibrosis. This could indicate a reduced tendency towards the development of stenosis when compared to EBD alone. There was not a difference in luminal size between stent and non-stented rabbits at the six-week end point. Histologically, however, overall the use of bioabsorbable UHD-Mg alloy stenting elicited a greater tissue response at the level of the superficial mucosa rather than fibrosis of the lamina propria seen in the stented rabbits. This suggests more favorable healing and less of a tendency towards fibrosis and stenosis even though there may not be a benefit from a luminal size standpoint during this early healing period. Compared to known complications of currently available non-bioabsorbable metal or silicone-based stents, this proof-of-concept investigation highlights the potential use of a novel biodegradable UHD-Mg stent as a therapeutic modality for pediatric SGS.

Cost-effectiveness of Resonance® metallic ureteral stent compared with standard polyurethane ureteral stents in malignant ureteric obstruction: A cost-utility analysis.

Background: Malignant ureteral obstruction (MUO) is a frequent challenge for urologists. Patients have poor prognoses, treatment aims to improve quality-of-life while optimising renal function. Standard practice in the United Kingdom is to use polyurethane stents, which require frequent surgical replacements for blockages and encrustation. More durable metallic stents are available, although these incur an increased initial purchase price. Aims: We aim to assess whether the use of polyurethane double-J (JJ) or metallic stent, Resonance® is more cost-effective for managing MUO in the UK healthcare setting. Methods: A Markov model was parameterised to 5 years with costs and health-related quality-of-life consequences for treating MUO with Resonance metallic stent (Cook Medical), versus standard JJ stents, from the UK care system perspective, with 3.5% discounting. Deterministic and probabilistic sensitivity analyses were undertaken to assess the effect of uncertainty. Results: Over 5 years, approximately four fewer repeat surgical interventions were estimated in the metallic stent arm compared with the JJ stent, driving a 23.4% reduction in costs. The mean estimates of costs and benefits indicate that treatment of MUO with Resonance for 5 years is dominant over JJ stents. Over 5 years a cost-saving of £2164.74 and a health gain of +0.046 quality-adjusted life years (QALYs) per patient is estimated. With a maximum willingness to pay of £20 k per QALY, a net monetary benefit (NMB) of £3077.83 is estimated. Probabilistic sensitivity analysis at a willingness to pay threshold of £20 000 indicates an 89.3% probability of Resonance being cost-effective over JJ stents. Within 1-year savings of £726.53 are estimated driven by a reduction of two fewer repeat surgical interventions when using the metallic stent. Conclusions: Resonance metallic stents for the treatment of MUO reduce the number of repeat procedures and could be a cost-effective option for the treatment, potentially offering efficiencies to the healthcare system.

A Cost-Consequence Analysis Comparing Balloon-Expandable Covered Stents for the Management of Aortoiliac Occlusive Disease.

PURPOSE: To compare procedural and long-term costs associated with the use of Balloon-Expandable Covered Stents (BECS) in the management of Aortoiliac Occlusive Disease (AIOD). MATERIALS AND METHODS: A cost-consequence model was developed to simulate the intra- and post-operative management of patients with AIOD from the perspective of private health-payers. The study assessed the costs of the LifeStream (BD, Franklin Lakes, New Jersey), iCAST/Advanta V12 (Getinge, Goteborg, Sweden), BeGraft Peripheral (Bentley, Hechingen, Germany), and Viabahn Balloon Expandable (VBX) (W.L. Gore, Flagstaff, Arizona) BECS devices. Device costs were identified from the Australian Prosthesis List, whereas clinical outcomes of BECS were estimated from a systematic review of the literature. Costs were calculated over 24 and 36 month time horizons and reported in US dollars. RESULTS: Long-term, per-patient cost of each device at 24 and 36 months was $6253/$6634 for the LifeStream; $6359/$6869 for the iCAST/Advanta V12; $4806 (data available to 24 months) for the BeGraft Peripheral; and $4839/$5046 for the Viabahn VBX, respectively. Most of the cost difference was attributed to the number of stents required per treated limb and frequency of clinically-driven target lesion revascularization events. CONCLUSIONS: Best-available clinical evidence and economic modeling demonstrates that the BeGraft Peripheral and Viabahn VBX were of similar cost and the least costly options at 24 months, whereas at 36 months, the lowest cost BECS option for the treatment of AIOD was the Viabahn VBX. CLINICAL IMPACT: This analysis supports economically informed decision-making for health-payers managing systems that care for patients with AIOD. Stent length and avoiding reintervention were identified as key areas of cost-saving for future BECS development.

Assessment of mouth opening before and after head and neck radiotherapy in patients with intraoral stents.

Background: We evaluated the evolution of mouth opening before and after radiotherapy of the head and neck in patients using intraoral stents. Materials and methods: Twenty-one patients with head and neck cancer who were indicated for radiotherapy participated in this study. Maximum interincisal opening measurements were performed before and after radiotherapy. Paired analyses of the pre- and post-radiotherapy groups were performed using paired samples t-tests and correlation analyses using Spearman's correlation test, with p < 0.05 considered statistically significant. Results: Paired analyses of the pre- and post-radiotherapy groups revealed a statistically significant reduction in post-radiotherapy maximum interincisal opening (p < 0.001). However, only four individuals were diagnosed with trismus after radiotherapy. Regarding the correlation tests, no statistically significant differences were observed between the differences in pre- and post-radiotherapy maximum interincisal opening values and the study variables. Conclusion: The use of prosthetic devices during head and neck radiotherapy can reduce radiation doses in areas of no interest, thereby preventing the acute and late toxicities associated with cancer therapy.

Racial Disparities and Outcomes of Percutaneous Coronary Interventions in Patients Above 65 Years in America: A Systematic Review.

This systematic review aims to examine the racial disparities and outcomes of percutaneous coronary interventions (PCIs) in patients above 65 years in America. The review follows the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines 2020 and includes a comprehensive search strategy, study selection, data extraction, and quality assessment. The search strategy identified 10 relevant articles that were included in the review. The findings indicate that racial disparities exist in access to PCI, door-to-balloon (DTB) time, procedure utilization, and outcomes among elderly patients. African American and Hispanic patients were found to experience longer door-to-balloon time and lower rates of PCI utilization compared to White patients. Moreover, racial and ethnic minorities had worse clinical outcomes, including higher mortality rates and increased risk of major adverse cardiovascular events. The review also highlights the impact of Medicaid expansion on reducing disparities in access, treatment, and outcomes for patients with acute myocardial infarction (AMI). However, limitations in data availability and representation of racial and ethnic minorities in clinical trials were identified. The discussion section provides a robust analysis of the findings, exploring potential underlying factors contributing to the observed disparities. The review concludes that addressing racial disparities in PCI outcomes among elderly patients is crucial for achieving equitable healthcare delivery and improving cardiovascular health outcomes in America.

Ureteral stenting in the clinic: a safe and cost-effective alternative to the operating room.

PURPOSE: Ureteral stent placement is one of the most common procedures performed by urologists, and is typically done in the operating room. At Ochsner-LSU Health Shreveport, urologists have a unique setting allowing them to place ureteral stents for patients present in the outpatient ambulatory clinic without the need for nitrous oxide. This allows patients to avoid being admitted to the hospital and receiving subsequent general anesthesia in the operating room. Therefore, our novel study evaluates the feasibility, safety, and cost-effectiveness of ureteral stents insertion in the clinic. MATERIAL AND METHODS: In this study, we analyzed 240 patients with a total of 279 different ureteral stent insertion encounters to evaluate the safety and costs of stenting in the clinic compared to the operating room. Stents were placed in the outpatient clinic for 126 patients, which required either a new ureteral stent insertion or a scheduled stent exchange. RESULTS: Overall, there was an increased age and length of stent duration among those who were stented in the clinic. We did not observe any increase in narcotics use, pain, adverse injuries, or differences in stent length. The total cost of a stent insertion operating room was $16,349.91 whereas the clinic procedure cost $7,865.69, however: medicare reimbursement remained the same. CONCLUSION: Our findings demonstrate a novel use of stenting in the clinic is feasible as an outpatient alternative. It is a safe alternative to the operating room, and more cost-effective.

Management strategy for urologic morbidity in surgery of placenta accreta spectrum: stents or catheters?

OBJECTIVE: Surgery for placenta accreta spectrum disorders is known to be associated with urologic morbidity. Although previous studies have shown preoperative ureteral stent placement might be useful for preventing the urologic morbidity, the patient's discomfort caused by it should not be ignored. Whether there is an alternative management strategy remains unknown. This study was to evaluate the effectiveness of ureteral stents and catheters in preventing urologic injury in patients with placenta accreta spectrum undergoing surgery. METHODS: We conducted a retrospective cohort study. All cases with diagnosed placenta accreta spectrum who underwent surgery at Peking University Third Hospital between January 2018 and December 2020 were collected and reviewed. They were divided into two groups according to the different management strategies for preoperative placement of ureteral catheters or stents. The primary outcome was urologic injury, which was defined as the presence of ureteral or bladder injury during and after surgery. Secondary outcomes included urologic complications within the first three months after surgery. The median (interquartile range) or proportions were reported for variables. The Man Whitney U test, chi-square test and multivariate logistic regression were used for analysis. RESULTS: Ultimately, 99 patients were included in this study. Ureteral catheters were placed in 52 patients and ureteral stents were placed in 47 patients. Placenta accreta, placenta increta, and placenta percreta were diagnosed in three, 19, and 77 women, respectively. The hysterectomy rate was 52.53%. Overall, urologic injuries occurred in three patients (3.03%), including one case of combined bladder and ureteral injury (1.01%) and two cases of bladder injuries (2.02%). Only one ureteral injury occurred in a patient with a ureteral stent, which was recognized postoperatively (p = .475). All bladder injuries were vesical rupture which were recognized and repaired intraoperatively; one patient in the catheter group and two patients in the stent group (p = .929). After adjusting for confounding variables, multinomial regression analysis revealed no significant differences between the two groups in the incidence of bladder injuries(aOR: 0.695, 95% CI: 0.035-13.794, p = .811). A lower risk of urinary irritation (aOR: 0.186, 95% CI: 0.057-0.605, p = .005), hematuria (aOR: 0.011, 95% CI: 0.001-0.136, p < .001), and lower back pain (aOR: 0.075, 95% CI: 0.022-0.261, p < .001) was found in patients with ureteral catheters than in those with ureteral stents. CONCLUSION: The ureteral stents didn't confer a protective benefit in the surgical management for placenta accreta spectrum compare with catheters; however, they did result in a higher incidence of postoperative urologic complications. Ureteral temporal catheters may be an alternative strategy for placenta accreta spectrum cases suspected with urinary tract involved prenatally. Moreover, clearly and explicitly reporting "double J stent" or "temporal catheter" is necessary for future researches.

Multilevel Assessment of Stent-Induced Inflammation in the Adjacent Vascular Tissue.

A recent U.S. Food and Drug Administration report presented the currently available scientific information related to biological response to metal implants. In this work, a multilevel approach was employed to assess the implant-induced and biocorrosion-related inflammation in the adjacent vascular tissue using a mouse stent implantation model. The implications of biocorrosion on peri-implant tissue were assessed at the macroscopic level via in vivo imaging and histomorphology. Elevated matrix metalloproteinase activity, colocalized with the site of implantation, and histological staining indicated that stent surface condition and implantation time affect the inflammatory response and subsequent formation and extent of neointima. Hematological measurements also demonstrated that accumulated metal particle contamination in blood samples from corroded-stetted mice causes a stronger immune response. At the cellular level, the stent-induced alterations in the nanostructure, cytoskeleton, and mechanical properties of circulating lymphocytes were investigated. It was found that cells from corroded-stented samples exhibited higher stiffness, in terms of Young's modulus values, compared to noncorroded and sham-stented samples. Nanomechanical modifications were also accompanied by cellular remodeling, through alterations in cell morphology and stress (F-actin) fiber characteristics. Our analysis indicates that surface wear and elevated metal particle contamination, prompted by corroded stents, may contribute to the inflammatory response and the multifactorial process of in-stent restenosis. The results also suggest that circulating lymphocytes could be a novel nanomechanical biomarker for peri-implant tissue inflammation and possibly the early stage of in-stent restenosis. Large-scale studies are warranted to further investigate these findings.

[Brain aneurysms treatment with pCONus2 device. Initial experience at IMSS]. / Aneurismas cerebrales tratados con dispositivo pCONus2. Experiencia inicial en el IMSS.

Background: pCONus2 device has been used in some countries as coadyuvant in the treatment of wide-neck bifurcation aneurysms with coils. Objective: To present the first series of brain aneurysms treated with pCONus2 in the Mexican Institute for Social Security (IMSS). Material and methods: We retrospectively present the first 13 aneurysms treated from October 2019 to February 2022 with pCONus2 device at a third level hospital. Results: 6 aneurysms located at anterior communicating artery, 3 at middle cerebral artery bifurcation, 2 at internal carotid artery bifurcatión, and 2 at the tip of basilar artery were treated. Device deployment was performed without complications and it was possible to embolize aneurysms with coils in 12 patients (92%), while on an internal carotid bifurcation aneurysm (8%) there was an incident of a pCONus2 petal migration toward vascular lumen caused by coils mesh pressure, situation that was solved by placing an nitinol self-expandable microstent. In 7 cases (54%) we performed coiling technique after microcatheter passage through pCONus2, while in 6 cases (46%) we used the jailing technique without complications. Conclusions: pCONus2 is a useful device for wide-neck bifurcation aneurysms embolization. In Mexico our experience is yet limited; however, the first cases have been successful. Furthermore, we showed the first cases treated using jailing technique. Much more cases are required in order to carry out a statistically conclusive analysis and to establish the effectiveness and safety of the device.

Introducción: el dispositivo pCONus2 ha sido usado en algunos países como coadyuvante en el tratamiento con coils de los aneurismas de cuello ancho localizados en las bifurcaciones. Objetivo: presentar los primeros aneurismas tratados con pCONus2 en el Instituto Mexicano del Seguro Social (IMSS). Material y métodos: se exponen retrospectivamente 13 casos de pacientes tratados con pCONus2 de octubre de 2019 a febrero de 2022 en un hospital de tercer nivel del IMSS. Resultados: se trataron 6 aneurismas de la arteria comunicante anterior, 2 de la bifurcación de la arteria carótida interna, 3 en la bifurcación de la arteria cerebral media y 2 del tope de la arteria basilar. El uso del pCONus2 se hizo sin complicaciones ni incidentes en 12 pacientes (92%), mientras que en un aneurisma de la bifurcación de carótida interna (8%) ocurrió la migración de un pétalo del dispositivo hacia la luz vascular, motivado por la presión de la malla de coils, que se solucionó con un microstent. Siete aneurismas (54%) fueron embolizados con coils después del paso del microcatéter a través del pCONus2, mientras que en 6 (46%) se utilizó la técnica jailing, sin complicaciones ni incidentes. Conclusiones: el pCONus2 es un dispositivo útil en la embolización de aneurismas localizados en bifurcaciones arteriales. En México la experiencia todavía es poca, pero los primeros casos han sido exitosos. Mostramos, además, los primeros casos tratados con la técnica de jailing. Se requieren más casos en nuestro país para hacer un análisis estadísticamente concluyente y determinar la efectividad y seguridad del dispositivo.

Variation in Carotid Artery Stenosis Measurements Among Facilities Seeking Carotid Stenting Facility Accreditation.

BACKGROUND: Based on the inclusion criteria of clinical trials, the degree of cervical carotid artery stenosis is often used as an indication for stent placement in the setting of extracranial carotid atherosclerotic disease. However, the rigor and consistency with which stenosis is measured outside of clinical trials are unclear. In an agreement study using a cross-sectional sample, we compared the percent stenosis as measured by real-world physician operators to that measured by independent expert reviewers. METHODS: As part of the carotid stenting facility accreditation review, images were obtained from 68 cases of patients who underwent carotid stent placement. Data collected included demographics, stroke severity measures, and the documented degree of stenosis, termed operator-reported stenosis (ORS), by 34 operators from 14 clinical sites. The ORS was compared with reviewer-measured stenosis (RMS) as assessed by 5 clinicians experienced in treating carotid artery disease. RESULTS: The median ORS was 90.0% (interquartile range, 80.0%-90.0%) versus a median RMS of 61.1% (interquartile range, 49.8%-73.6%), with a median difference of 21.8% (interquartile range, 13.7%-34.4%), P<0.001. The median difference in ORS and RMS for asymptomatic versus symptomatic patients was not statistically different (24.6% versus 19.6%; P=0.406). The median difference between ORS and RMS for facilities granted initial accreditation was smaller compared with facilities whose accreditation was delayed (17.9% versus 25.5%, P=0.035). The intraclass correlation between ORS and RMS was 0.16, indicating poor agreement. If RMS measurements were used, 72% of symptomatic patients and 10% of asymptomatic patients in the population examined would meet the Centers for Medicare and Medicaid Services criteria for stent placement. CONCLUSIONS: Real-world operators tend to overestimate carotid artery stenosis compared with external expert reviewers. Measurements from facilities granted initial accreditation were closer to expert measurements than those from facilities whose accreditation was delayed. Since decisions regarding carotid revascularization are often based on percent stenosis, such measuring discrepancies likely lead to increased procedural utilization.

Prevalence, Management and Outcomes of Percutaneous Coronary Intervention for Coronary In-Stent Restenosis: Insights From the France PCI Registry.

BACKGROUND: Despite the evolution of stent technology, there is a non-negligible risk of in-stent restenosis (ISR) after Percutaneous coronary intervention (PCI). Large-scale registry data on the prevalence and clinical management of ISR is lacking. METHODS: The aim was to describe the epidemiology and management of patients with ≥1 ISR lesions treated with PCI (ISR PCI). Data on characteristics, management and clinical outcomes were analyzed for patients undergoing ISR PCI in the France-PCI all-comers registry. RESULTS: Between January 2014 and December 2018, 31,892 lesions were treated in 22,592 patients, 7.3 % of whom underwent ISR PCI. Patients undergoing ISR PCI were older (68.5 vs 67.8; p < 0.001), and more likely to have diabetes (32.7 % vs 25.4 %, p < 0.001), chronic coronary syndrome or multivessel disease. ISR PCI concerned drug eluting stents (DES) ISR in 48.8 % of cases. Patients with ISR lesions were more frequently treated with DES than drug eluting balloon or balloon angioplasty (74.2 %, 11.6 % and 12.9 %, respectively). Intravascular imaging was rarely used. At 1 year, patients with ISR had higher target lesion revascularization rates (4.3 % vs. 1.6 %; HR 2.24 [1.64-3.06]; p < 0.001). CONCLUSIONS: In a large all-comers registry, ISR PCI was not infrequent and associated with worse prognosis than non-ISR PCI. Further studies and technical improvements are warranted to improve the outcomes of ISR PCI.

Covered stent treatment for arterial complications after pancreatic surgery: risk assessment for recurrence and peri-stent implantation management.

OBJECTIVES: To explore the risk factors for recurrence of arterial complications after pancreatectomy during the period of covered stent implantation and to provide some opinions on peri-stent implantation management. METHODS: Data on patients implanted with covered stents due to arterial complications after pancreatectomy between January 2017 and December 2021 were analyzed retrospectively. Technical success, clinical success, recurrence, and survival were evaluated to elucidate the practicability of covered stents. Wilson score, Random Forest, logistic regression, and Pearson's chi-square test with bootstrap aggregation were performed for determining the perioperative risk factors for recurrence. RESULTS: Among all fifty-five patients, success stent implantation (technical success) was achieved 100%. Patients who were hemodynamically stabilized without further treatment for artery complications in situ (clinical success) accounted for 89.1%. Based on statistical analysis, pre-stent implantation pancreatic fistula was identified as a robust recurrence-related risk factor for preoperative assessment (p = 0.02, OR = 4.5, 95% CI [1.2, 16.9]; pbootstrap = 0.02). Post-stent implantation pancreatic fistula (p = 0.01, OR 4.5, 95% CI [1.4, 14.6]; pbootstrap < 0.05) and SMA branches or GDA stumps (p = 0.02, OR 3.4, 95% CI [1.1, 10.3]) were relevant to recurrence. The survival rate during hospitalization was 87.3%. All survivors were free from recurrence during the subsequent follow-up. Vasospasm and stent occlusion were observed as short-term and long-term complications, respectively. CONCLUSION: A covered stent implantation is a feasible and effective treatment option for post-pancreatectomy arterial complications. Rigorous management of pancreatic fistula, timely detection of problems, sensible strategies during stent implantation, and reasonable anticoagulation therapy are necessary for a better prognosis. KEY POINTS: • A covered stent is feasible for various artery-related complications after pancreatectomy and has an ideal therapeutic effect. • Pancreatic fistula during the perioperative period of the covered stent is an independent risk factor for recurrent arterial complications and SMA branches or GDA stumps are prone to be recurrent offending arteries. • Rigorous management of pancreatic fistula, timely detection of problems, sensible strategies during stent implantation, and reasonable anticoagulation therapy are necessary for a better prognosis.

Avaliação no Mundo Real de um Stent Eluidor de Sirolimus de Hastes Ultrafinas em Pacientes com Infarto do Miocárdio com Supradesnivelamento do Segmento ST Submetidos à Intervenção Coronária Percutânea Primária (Registro INSTEMI) / Real-World Assessment of an Ultrathin Strut, Sirolimus-Eluting Stent in Patients with ST-Elevation Myocardial Infarction Submitted to Primary Percutaneous Coronary Intervention (INSTEMI Registry)

Resumo Fundamento O padrão-ouro atual dos stents farmacológicos (SF) coronários consiste em ligas metálicas com hastes mais finas e polímeros bioabsorvíveis. Objetivos Nosso objetivo foi comparar um stent eluidor de sirolimus de hastes ultrafinas (Inspiron®) com outras plataformas de SF de terceira geração em pacientes com infarto do miocárdio com supradesnivelamento do segmento ST (IAMCSST) submetidos à intervenção coronária percutânea (ICP) primária. Métodos Analisamos dados de um registro multicêntrico de IAMCSST de centros de referência da Região Sul do Brasil. Todos os pacientes foram submetidos à ICP primária, seja com Inspiron® ou outro SF de segunda ou terceira geração. Foi calculado pareamento por escore de propensão (PEP) para gerar grupos semelhantes (Inspiron® versus outros stents) em relação às características clínicas e do procedimento. Todos os testes de hipótese tiveram um nível de significância bilateral de 0,05. Resultados De janeiro de 2017 a janeiro de 2021, 1.711 pacientes foram submetidos à ICP primária, e 1.417 pacientes preencheram nossos critérios de inclusão (709 pacientes no grupo Inspiron® e 708 pacientes no grupo dos outros SF de segunda ou terceira geração). Após PEP, a amostra do estudo foi composta por 706 pacientes (353 pacientes no grupo Inspiron® e 353 pacientes no grupo dos demais SF de segunda ou terceira geração). As taxas de revascularização do vaso alvo (odds ratio [OR] 0,52; intervalo de confiança [IC] 0,21 a 1,34; p = 0,173), trombose de stent (OR 1,00; IC 0,29 a 3,48;p = 1,000), mortalidade (hazard ratio 0,724; IC 0,41 a 1,27; p = 0,257) e os desfechos cardiovasculares maiores (OR 1,170; IC 0,77 a 1,77; p = 0,526) foram semelhantes entre os grupos após um acompanhamento mediano de 17 meses. Conclusão Nossos achados mostram que o stent Inspiron® foi eficaz e seguro quando comparado a outros SF de segunda ou terceira geração em uma coorte contemporânea do mundo real de pacientes com IAMCSST submetidos à ICP primária.

Abstract Background The current gold standard of coronary drug-eluting stents (DES) consists of metal alloys with thinner struts and bioresorbable polymers. Objectives Our aim was to compare an ultrathin strut, sirolimus-eluting stent (Inspiron®) with other third-generation DES platforms in patients with ST-elevation myocardial infarction (STEMI) submitted to primary percutaneous coronary intervention (PCI). Methods We analyzed data from a STEMI multicenter registry from reference centers in the South Region of Brazil. All patients were submitted to primary PCI, either with Inspiron® or other second- or third-generation DES. Propensity score matching (PSM) was computed to generate similar groups (Inspiron® versus other stents) in relation to clinical and procedural characteristics. All hypothesis tests had a two-sided significance level of 0.05. Results From January 2017 to January 2021, 1711 patients underwent primary PCI, and 1417 patients met our entry criteria (709 patients in the Inspiron® group and 708 patients in the other second- or third-generation DES group). After PSM, the study sample was comprised of 706 patients (353 patients in the Inspiron® group and 353 patients in the other the other second- or third-generation DES group). The rates of target vessel revascularization (OR 0.52, CI 0.21 - 1.34, p = 0.173), stent thrombosis (OR 1.00, CI 0.29 - 3.48, p = 1.000), mortality (HR 0.724, CI 0.41 - 1.27, p = 0.257), and major cardiovascular outcomes (OR 1.170, CI 0.77 - 1.77, p = 0.526) were similar between groups after a median follow-up of 17 months. Conclusion Our findings show that Inspiron® was effective and safe when compared to other second- or third-generation DES in a contemporary cohort of real-world STEMI patients submitted to primary PCI.

Role of CT in the Pre- and Postoperative Assessment of Conotruncal Anomalies.

Conotruncal anomalies, also referred to as outflow tract anomalies, are congenital heart defects that result from abnormal septation of the great vessels' outflow tracts. The major conotruncal anomalies include tetralogy of Fallot, double-outlet right ventricle, transposition of the great arteries, truncus arteriosus, and interrupted aortic arch. Other defects, which are often components of the major anomalies, include pulmonary atresia with ventricular septal defect, pulmonary valve agenesis, aortopulmonary window, and double-outlet left ventricle. CT has emerged as a robust diagnostic tool in preoperative and postoperative assessment of various congenital heart diseases, including conotruncal anomalies. The data provided with multidetector CT imaging are useful for treatment planning and follow-up monitoring after surgery or intervention. Unlike echocardiography and MRI, CT is not limited by a small acoustic window, metallic devices, and need for sedation or anesthesia. Major advances in CT equipment, including dual-source scanners, wide-detector scanners, high-efficiency detectors, higher x-ray tube power, automatic tube current modulation, and advanced three-dimensional postprocessing, provide a low-risk, high-quality alternative to diagnostic cardiac catheterization and MRI. This review explores the various conotruncal anomalies and elucidates the role of CT imaging in their pre- and postoperative assessment. Keywords: CT, CT Angiography, Stents, Pediatrics © RSNA, 2022.

Patient-level and external factors in the use of drug-coated balloons and drug-eluting stents in femoropopliteal endovascular interventions.

OBJECTIVE: Drug-coated balloons (DCB) and drug-eluting stents (DES) have been rapidly adopted for femoropopliteal endovascular interventions due to their favorable patency rates. It is unclear whether choice of using drug coated devices versus bare metal stents (BMS) or plain balloon angioplasty (POBA) as primary treatment in femoropopliteal disease is mostly associated with patient-level factors, safety concerns, or by operator preferences. This study sought to evaluate factors associated with their use in a contemporary dataset. METHODS: All femoropopliteal lesions treated with endovascular interventions between 2016 and 2019 from the Vascular Quality Initiative registry were included. For each procedure, a primary treatment was identified based on the following hierarchy: DES > DCB > BMS > POBA. A hierarchical logistic regression model predicting DCB or DES use included patient-level characteristics, key events (period after Centers for Medicare and Medicaid Services reimbursement change, January 2018 [vs before] and period after Katsanos meta-analysis December 2018 [vs before]), and random effects for site and operator. Operator-level variability for DCB and DES use was summarized with an adjusted median odds ratio (MOR). RESULTS: A total of 57,753 femoropopliteal endovascular procedures were included. Poor functional status (odds ratio [OR], 0.92; 95% confidence interval [CI], 0.90-0.94), prior anticoagulant use (OR, 0.92; 95% CI, 0.87-0.97), higher Rutherford classification (OR, 0.86; 95% CI, 0.84-0.88), chronic kidney disease stage 4 or 5 (OR, 0.92; 95% CI, 0.86-0.98), and the period after the Katsanos meta-analysis publication (OR, 0.3; 95% CI, 0.29-0.32) were associated with a lower odds of DCB or DES use; whereas female sex (OR, 1.12; 95% CI,1.08-1.17), prior lesion treatment (OR, 1.17; 95% CI, 1.11-1.22), diabetes (OR, 1.07; 95% CI, 1.02-1.12), Trans-Atlantic Inter-Society Consensus class B (OR, 1.16; 95% CI, 1.09-1.24) and C (OR, 1.2; 95% CI, 1.12-1.28), and the period after the Centers for Medicare and Medicaid Services reimbursement change (OR, 1.08; 95% CI, 1.03-1.14) were associated with a higher odds of DCB or DES use. Significant variability in use was found across operators (adjusted MOR, 2.70; 95% CI, 2.55-2.85) and centers (adjusted MOR, 2.89; 95% CI, 2.50-3.27). CONCLUSIONS: DCB or DES use in femoropopliteal disease demonstrates wide variability across operators and is linked strongly with external factors, followed by anatomic lesion characteristics and a history of previous interventions. Future work needs to focus on tailoring DCB or DES use to patient and lesion characteristics and to develop appropriate use guidelines integrating these factors.

Covered TIPS Procedure-Related Major Complications: Incidence, Management and Outcome From a Single Center.

Background and Objective: Transjugular intrahepatic portosystemic shunt (TIPS) is a well-established procedure for treating complications of portal hypertension. Due to the complexity of anatomy and difficulty of the puncture technique, the procedure itself might brought potential complications, such as puncture failure, bleeding, infection, and, rarely, death. The aim of this study is to explore the incidence, management, and outcome of TIPS procedure-related major complications using covered stents. Methods: Patients who underwent TIPS implantation from January 2015 to December 2020 were recruited retrospectively. Major complications after TIPS were screened and analyzed. Results: Nine hundred and forty-eight patients underwent the TIPS procedure with 95.1% (n = 902) technical success in our department. TIPS procedure-related major complications occurred in 30 (3.2%) patients, including hemobilia (n = 13; 1.37%), hemoperitoneum (n = 7; 0.74%), accelerated liver failure (n = 6; 0.63%), and rapidly progressive organ failure (n = 4; 0.42%). Among them, 8 patients died because of hemobilia (n = 1), accelerated liver failure (n = 4), and rapidly progressive organ failure (n = 3). Conclusion: The incidence of major complications related to TIPS procedure is relatively low, and some of them could recover through effective medical intervention. In our cohort, the overall incidence is about 3%, which causes 0.84% death. The most fatal complication is organ failure and hemobilia.

Clinical and angiographic assessment of the culotte technique for the treatment of complex coronary bifurcation lesions / Valoración clínica y angiográfica de la técnica de culotte para el tratamiento de lesiones complejas en bifurcaciones coronarias

Abstract Introduction: The current standard treatment for bifurcation lesions is the provisional stent technique, by implanting only one stent in the main branch; however, in certain cases, the use of more complex techniques that require double stenting should be considered. Objective: To perform a clinical and angiographic assessment of patients with true bifurcation lesions treated with the two-stent culotte technique. Materials and methods: A prospective study was done, which included patients diagnosed with significant obstructive coronary artery disease in bifurcation areas, who were candidates for angioplasty with culotte technique. The study included 44 patients with proved diagnosis of coronary bifurcation lesions; 66% of the treated bifurcation lesions compromised the anterior descending artery and the diagonal branch and 27%, the circumflex artery with the marginal branch. It was found that 68% of the cases had Medina 1,1,1 lesions and 23% had Medina 0,1,1 lesions. Six months later, it was found that 12.5% of the patients followed up by angiography had in-stent restenosis (ISR) > 50% that involved at least one of the bifurcation areas. In 9% of these patients, the ISR was at the origin of the side branch only, and in 3%, the ISR was confined to the distal segment of the main branch stent. Conclusion: The use of the culotte technique with two new-generation stents to treat complex coronary bifurcation lesions is an effective option and does not increase the risk of complications during the procedure nor the risk of the appearance of ISR.

Resumen Introducción: El tratamiento estándar actual para las lesiones en bifurcaciones es la técnica de stent provisional, implantando solo un stent en la rama principal, sin embargo, en ciertos casos, se debería considerar el uso de técnicas más complejas que requieren de doble stent. Objetivo: Realizar una evaluación clínica y angiográfica de pacientes con verdaderas lesiones en bifurcaciones tratados con la técnica culotte de doble stent. Material y métodos: Se realizó un estudio prospectivo que incluyó pacientes diagnosticados con enfermedad obstructiva significativa de arterias coronarias en bifurcaciones, quienes eran candidatos a angioplastia con la técnica culotte. El estudio incluyó 44 pacientes con un diagnóstico comprobado de lesiones coronarias en bifurcaciones; el 66% de las lesiones en bifurcaciones tratadas comprometían la arteria descendente anterior y la rama diagonal, y el 27% la arteria circunfleja con la rama marginal. Se encontró que el 68% de los casos tenían lesiones Medina 1,1,1 y el 23% tenían lesiones Medina 0,1,1. A los seis meses, se encontró que el 12,5% de los pacientes en seguimiento con angiografía presentaban reestenosis intrastent (RIS) mayor al 50%, que comprometía al menos una de las áreas de bifurcación. En el 9% de estos pacientes, la RIS se ubicaba únicamente en el origen de la rama lateral, y en el 3%, la RIS se restringió al segmento distal del stent de la rama principal. Conclusiones: El uso de la técnica culotte empleando dos stents de nueva generación es una opción efectiva para tratar las lesiones complejas en bifurcaciones coronarias, y no aumenta el riesgo de complicaciones durante el procedimiento ni el riesgo de la aparición de reestenosis intrastent.

Biodegradable ureteral stents: in vitro assessment of the degradation rates of braided synthetic polymers and copolymers.

OBJECTIVES: The control and predictability of degradation rates and the absence of obstructive phenomena are two main challenges for research regarding biodegradable ureteral stents. The objectives are to assess the degradation performance and safety of braided combinations of three synthetic biodegradable polymers and copolymers; and to evaluate the interference of a heparin dip coating on degradation and bacterial colonization. METHODS: The hydrolysis of polyglycolic acid (PGA), poly lactic-co-glycolic acid (PLGA) and Glycomer™ 631 is assessed in this in vitro study that comprises ten groups. Stent samples present a braided arrangement and are incubated in porcine urine that undergoes analysis and exchange every 48 h until degradation. Coating is carried out with sodium heparin via dip coating and determination of the heparin release is carried out by ELISA test. Variables of study are stent mass, mass fold change, degradation time, bacterial colonization and concentration of heparin released in artificial urine. RESULTS: There is statistical significance in degradation times between all materials except between the Glycomer™ 631 alone and combined with PGA. Mass fold change analysis of the Glycomer™ 631 evidences an increasing trend of its mass during degradation. The combination of Glycomer™ 631 and PGA presents a progressive and gradual degradation, where PGA degrades at week 3 while Glycomer™ 631 remains intact until its fragmentation at the late stage of degradation. Heparin coating has no significant impact on mean degradation times and trends in any group, nor on bacteriuria rates; heparin concentration decreases significantly after 72 h. Products of degradation are released steadily with minimum dimensions. CONCLUSIONS: The combination of synthetic biodegradable polymers and copolymers with different degradation rates provides a gradual staged degradation. Heparin dip coating is a safe and feasible technique to coat biodegradable ureteral stents without interfering in degradation rates although it does not have a significant effect on the onset of bacterial colonization.

CT angiography for the assessment of EVAR complications: a pictorial review.

Endovascular aneurysm repair (EVAR) is a minimally invasive treatment proposed as an alternative to open repair in patients with abdominal aortic aneurysms. EVAR consists in a stent-graft placement within the aorta in order to exclude the aneurysm from arterial circulation and reduce the risk of rupture. Knowledge of the various types of devices is mandatory because some stents/grafts are more frequently associated with complications. CT angiography is the gold standard diagnostic technique for preprocedural planning and postprocedural surveillance. EVAR needs long-term follow-up due to the high rate of complications. Complications can be divided in endograft device-related and systemic complications. The purpose of this article is to review the CT imaging findings of EVAR complications and the key features for the diagnosis.

Editor's Choice - Cost Effectiveness of Primary Stenting in the Superficial Femoral Artery for Intermittent Claudication: Two Year Results of a Randomised Multicentre Trial.

OBJECTIVE: Invasive treatment of intermittent claudication (IC) is commonly performed, despite limited evidence of its cost effectiveness. IC symptoms are mainly caused by atherosclerotic lesions in the superficial femoral artery (SFA), and endovascular treatment is performed frequently. The aim of this study was to investigate its cost effectiveness vs. non-invasive treatment. METHODS: One hundred patients with IC due to lesions in the SFA were randomised to treatment with primary stenting, best medical treatment (BMT) and exercise advice (stent group), or to BMT and exercise advice alone (control group). Patients were recruited at seven hospitals in Sweden. For this analysis of cost effectiveness after 24 months, 84 patients with data on quality adjusted life years (QALY; based on the EuroQol Five Dimensions EQ-5D 3L™ questionnaire) were analysed. Patient registry and imputed cost data were used for accumulated costs regarding hospitalisation and outpatient visits. RESULTS: The mean cost per patient was €11 060 in the stent group and €4 787 in the control group, resulting in a difference of €6 273 per patient between the groups. The difference in mean QALYs between the groups was 0.26, in favour of the stent group, which resulted in an incremental cost effectiveness ratio (ICER) of € 23 785 per QALY. CONCLUSION: The costs associated with primary stenting in the SFA for the treatment of IC were higher than for exercise advice and BMT alone. With concurrent improvement in health related quality of life, primary stenting was a cost effective treatment option according to the Swedish national guidelines (ICER < €50 000 - €70 000) and approaching the UK's National Institute for Health and Care Excellence threshold for willingness to pay (ICER < £20 000 - £30 000). From a cost effectiveness standpoint, primary stenting of the SFA can, in many countries, be used as an adjunct to exercise training advice, but it must be considered that successful implementation of structured exercise programmes and longer follow up may alter these findings.