Impact of gender on in-hospital and long-term outcomes after transcatheter aortic valve implantation: an analysis of the Spanish TAVI registry.

INTRODUCTION AND OBJECTIVES: Impact of gender on long-term outcomes after transcatheter aortic valve implantation (TAVI) remains uncertain. We aimed to investigate gender-specific differences in TAVI and its impact on outcomes. METHODS: This analysis used data from the prospective Spanish TAVI registry, which included consecutive TAVI patients treated in 46 Spanish centers from 2009 to 2021. The primary endpoint was all-cause mortality at 12 months. Secondary endpoints included in-hospital and 30-day mortality and TAVI-related complications. Adjusted logistic and Cox regression analyses were performed. RESULTS: The study included 12 253 consecutive TAVI patients with a mean age of 81.2 ± 6.4 years. Women (53.9%) were older, and had a higher STS-PROM score (7.0 ± 7.0 vs 6.2 ± 6.7; P < .001) than men. Overall, the TAVI-related complication rate was similar between women and men, with specific gender-related complications. While women more frequently developed in-hospital vascular complications (13.6% vs 9.8%; P < .001) and cardiac tamponade (1.5% vs 0.6%; P = .009), men showed a higher incidence of permanent pacemaker implantation (14.5% vs 17.4%; P = .009). There was no difference in all-cause mortality either in hospital (3.6% vs 3.6%, adjusted odds ratio [OR], 1.01; 95% confidence interval [95%CI], 0.83-1.23; P = .902), at 30 days (4.2% vs 4.2%, adjusted OR, 0.90; 95%CI, 0.65-1.25; P = .564) or at 1 year (11% vs 13%, adjusted HR, 0.94; [0.80-1.11]; P = .60). CONCLUSIONS: women treated with TAVI are older and have more comorbidities than men, leading to distinct complications between genders. Nevertheless, all-cause mortality in the short-term and at 1-year was similar between men and women.

Risks to Human Health from Mercury in Gold Mining in the Coastal Region of Ecuador.

Artisanal and small-scale gold mining (ASGM) plays a crucial role in global gold production. However, the adoption of poor mining practices or the use of mercury (Hg) in gold recovery processes has generated serious environmental contamination events. The focus of this study is assessing the concentration of Hg in surface waters within the coastal region of Ecuador. The results are used to conduct a human health risk assessment applying deterministic and probabilistic methods, specifically targeting groups vulnerable to exposure in affected mining environments. Between April and June 2022, 54 water samples were collected from rivers and streams adjacent to mining areas to determine Hg levels. In the health risk assessment, exposure routes through water ingestion and dermal contact were considered for both adults and children, following the model structures outlined by the U.S. Environmental Protection Agency. The results indicate elevated Hg concentrations in two of the five provinces studied, El Oro and Esmeraldas, where at least 88% and 75% of the samples, respectively, exceeded the maximum permissible limit (MPL) set by Ecuadorian regulations for the preservation of aquatic life. Furthermore, in El Oro province, 28% of the samples exceeded the MPL established for drinking water quality. The high concentrations of Hg could be related to illegal mining activity that uses Hg for gold recovery. Regarding the human health risk assessment, risk values above the safe exposure limit were estimated. Children were identified as the most vulnerable receptor. Therefore, there is an urgent need to establish effective regulations that guarantee the protection of river users in potentially contaminated areas. Finally, it is important to continue investigating the contamination caused by human practices in the coastal region.

PSF and MTF from a bar pattern in digital mammography.

Background.The MTF has difficulties being determined (according to the provisions of the IEC standards) in the hospital setting due to the lack of resources.Purpose.The objective of this work is to propose a quantitative method for obtaining the point spread function (PSF) and the modulation transfer function (MTF) of a digital mammography system from an image of a bar pattern.Methods.The method is based on the measurement of the contrast transfer function (CTF) of the system over the image of the bar pattern. In addition, a theoretical model for thePSFis proposed, from which the theoreticalCTFof the system is obtained by means of convolution with a square wave (mathematical simulation of the bar pattern). Through an iterative process, the free parameters of thePSFmodel are varied until the experimentalCTFcoincides with the one calculated by convolution. Once thePSFof the system is obtained, we calculate theMTFby means of its Fourier transform. TheMTFcalculated from the modelPSFhave been compared with those calculated from an image of a 65µm diameter gold wire using an oversampling process.Results.TheCTFhas been calculated for three digital mammographic systems (DMS 1, DMS 2 and DMS 3), no differences of more than 5 % were found with the CTF obtained with the PSF model. The comparison of theMTFshows us the goodness of thePSFmodel.Conclusions.The proposed method for obtainingPSFandMTFis a simple and accessible method, which does not require a complex configuration or the use of phantoms that are difficult to access in the hospital world. In addition, it can be used to calculate other magnitudes of interest such as the normalized noise power spectrum (NNPS) and the detection quantum efficiency (DQE).

Analysis of Mercury in Aquifers in Gold Mining Areas in the Ecuadorian Amazon and Its Associated Risk for Human Health.

Gold mining activity is a source of supply in many areas of the world, and especially in developing countries, it is practiced illegally and by applying unsafe techniques. Particularly in Ecuador, artisanal and small-scale gold mining (ASGM) is widespread, and it is based on the use of toxic substances, such as mercury (Hg), in gold recovery. Hg is a heavy metal that is water-insoluble, which, once mobilized, poses a threat to both the environment and human health. This study analyzes Hg concentrations in the six provinces of Napo, Sucumbíos, Orellana, Pastaza, Morona Santiago, and Zamora Chinchipe of the Ecuadorian Amazon region to conduct a human health risk assessment. Significant differences in Hg levels were found between provinces, but concentrations were below MPL imposed by Ecuadorian regulations everywhere. Nevertheless, a worrisome picture emerges, especially with regard to the most vulnerable receptors represented by the child population. There are multiple factors of incidence that may affect the possible future development of the phenomenon, and with reference to the social, economic, and environmental context of the region, it can be concluded that it may be appropriate to plan further investigation to arrive at a more comprehensive assessment. The results of this study can be used by decision makers to plan further investigation and to implement monitoring networks, risk mitigation strategies, and groundwater protection measures.

Human health risk assessment due to mercury use in gold mining areas in the Ecuadorian Andean region.

Mining activity drives economic development and has established itself as one of the main industrial spheres globally. However, illegal, and artisanal gold mining, which uses mercury (Hg), is a major source of global pollution. Hg is highly toxic and persistent in the environment, affecting human health and the ecosystem. The objective of this research is to; (a) analyze Hg concentrations in surface waters of nine provinces of the Andean region of Ecuador and compare them with the maximum permissible limits of Ecuadorian regulations, and (b) evaluate the health risk of people exposed to waters with high Hg content through residential and recreational scenarios. In this study, 147 water samples from rivers and streams were analyzed. The results revealed worrying levels of Hg, especially in the provinces of Azuay and Loja where Hg values of up to 0.0913 mg/L and 0.0387 mg/L, respectively, were detected. In addition, it was found that 45% of the samples did not meet the water quality criteria for the preservation of aquatic life, which represents a severe risk to the ecosystem. The probabilistic risk analysis yielded values that exceeded the acceptable exposure limit for adults and children in residential settings in Azuay and Loja, while in the recreational scenario the safe exposure limit was exceeded for both receptors only in the province of Azuay. The elevated presence of Hg in the provinces, mainly in Azuay and Loja, possibly related to illegal gold mining activity, represents a threat to water quality and aquatic life in the Andean region of Ecuador. Children are especially vulnerable, and effective regulation is required to ensure the safety of the population. This study provides valuable information for decision makers regarding the risk associated with Hg exposure in areas of mining activity in the Ecuadorian Andean region. In addition, it can contribute to the development of policies and strategies to control contamination in mining environments and protect human and environmental health in the region.

Edible Fruits from the Ecuadorian Amazon: Ethnobotany, Physicochemical Characteristics, and Bioactive Components.

In the Ecuadorian Amazon region, there are various types of edible fruits that have distinct qualities and benefits. Understanding the uses, properties, and functions of these fruits is important for researching products that are only available in local markets. This review aims to gather and summarize the existing scientific literature on the ethnobotany, physicochemical composition, and bioactive compounds of these native fruits to highlight the potential of the region's underutilized biodiversity. A systematic review was carried out following the PRISMA methodology, utilizing databases such as Web of Science, Scopus, Pubmed, Redalyc, and SciELO up to August 2023. The research identified 55 edible fruits from the Ecuadorian Amazon and reported their ethnobotanical information. The most common uses were fresh fruit consumption, preparation of typical food, and medicine. Additionally, nine native edible fruits were described for their physicochemical characteristics and bioactive components: Aphandra natalia (Balslev and Henderson) Barfod; Eugenia stipitate McVaugh; Gustavia macarenensis Philipson; Mauritia flexuosa L.f; Myrciaria dubia (Kunth) McVaugh; Oenocarpus bataua Mart; Plukenetia volubilis L.; Pouteria caimito (Ruiz and Pav.) Radlk.; and Solanum quitoense Lam. The analyzed Amazonian fruits contained bioactive compounds such as total polyphenols, flavonoids, carotenoids, and anthocyanins. This information highlights their potential as functional foods and the need for further research on underutilized crops.

Assessment of Hg pollution in stream waters and human health risk in areas impacted by mining activities in the Ecuadorian Amazon.

Illegal gold mining activities have contributed to the release and mobilization of Hg and environmental degradation in many parts of the world. This study aims to determine the concentration of Hg in five provinces of the Amazon Region of Ecuador, in addition to assessing the risk to human health of exposed populations, applying deterministic and probabilistic methods. For this purpose, 147 water samples were collected in rivers and streams crossing and/or located near mining areas. As a result, 100% of the samples analyzed exceeded the maximum permissible limit (MPL) according to the water quality criteria for the preservation of aquatic life of the Ecuadorian regulations, while 7% of the samples exceeded the MPL for drinking water. On the other hand, considering the European Environmental Quality Standard (EQS) for surface water bodies, in our study, 100% of the samples exceed the maximum permissible limit (0.07 µg/L), and with respect to the Canadian water quality guidelines, 35% of the samples exceed the permissible limit (0.001 mg/l) for drinking water, and 100% of the samples exceed the limit for life in water bodies (0.0001 mg/l). The risk assessment revealed that the probability of developing adverse health effects from exposure to Hg is below the recommended limits according to the probabilistic assessment; this is in relation to the criterion of residential and recreational use of water resources. However, it was identified that the child population doubles the acceptable systemic risk level according to the results of the deterministic assessment in the residential scenario. This information can be used by decision-makers to implement strategies to reduce Hg contamination and exposure of the population in Ecuadorian Amazonian rivers.

Instantaneous Wave-Free Ratio for the Assessment of Intermediate Left Main Coronary Artery Stenosis: Correlations With Fractional Flow Reserve/Intravascular Ultrasound and Prognostic Implications: The iLITRO-EPIC07 Study.

BACKGROUND: There is little information available on agreement between fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) in left main coronary artery (LMCA) intermediate stenosis. Besides, several meta-analyses support the use of FFR to guide LMCA revascularization, but limited information is available on iFR in this setting. Our aims were to establish the concordance between FFR and iFR in intermediate LMCA lesions, to evaluate with intravascular ultrasound (IVUS) in cases of FFR/iFR discordance, and to prospectively validate the safety of deferring revascularization based on a hybrid decision-making strategy combining iFR and IVUS. METHODS: Prospective, observational, multicenter registry with 300 consecutive patients with intermediate LMCA stenosis who underwent FFR and iFR and, in case of discordance, IVUS and minimal lumen area measurements. Primary clinical end point was a composite of cardiovascular death, LMCA lesion-related nonfatal myocardial infarction, or unplanned LMCA revascularization. RESULTS: FFR and iFR had an agreement of 80% (both positive in 67 and both negative in 167 patients); in case of disagreement (31 FFR+/iFR- and 29 FFR-/iFR+) minimal lumen area was ≥6 mm2 in 8.7% of patients with FFR+ and 14.6% with iFR+. Among the 300 patients, 105 (35%) underwent revascularization and 181 (60%) were deferred according to iFR and IVUS. At a median follow-up of 20 months, major adverse cardiac events incidence was 8.3% in the defer group and 13.3% in the revascularization group (hazard ratio, 0.71 [95% CI 0.30-1.72]; P=0.45). CONCLUSIONS: In patients with intermediate LMCA stenosis, a physiology-guided treatment decision is feasible either with FFR or iFR with moderate concordance between both indices. In case of disagreement, the use of IVUS may be useful to indicate revascularization. Deferral of revascularization based on iFR appears to be safe in terms of major adverse cardiac events. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT03767621.

History, Socioeconomic Problems and Environmental Impacts of Gold Mining in the Andean Region of Ecuador.

Mining in Ecuadorian territory comprises three stages of Ecuadorian history: pre-Columbian, colonial, and republican times. In its beginnings, this activity did not have regulations or a legal foundation. The first Mining Law dates back to 1830, and it has been modified until the most recent update in 2009. The Andean region consists of 10 provinces, 9 of which have registered gold concessions, the most important of which are Loja, Azuay, and in recent years, Imbabura and Pichincha, which are the provinces with the highest number of reported concessions. The objective of this study focused on analyzing the historical and current situation of Artisanal and Small-scale Mining (ASGM) and the emergence of large-scale (industrial) mining. For the elaboration of this study, different methodological techniques were used, such as literature review, field interviews, and expert judgment validation. The main findings show that the provinces of Loja, Azuay, Imbabura, and Pichincha are the most conflictive areas in the region due to the impacts caused by mining activities. In socio-economic terms, there are conflicts between inhabitants in favor and against these activities and problems associated with human health. In environmental terms, the findings suggest historical contamination of water sources by heavy metals, which has altered the surrounding aquatic and terrestrial systems. Finally, the study concludes that implementing public policies should be promoted to balance socio-economic and environmental aspects in gold mining activities in the Andean region of Ecuador, strengthening the use of new technologies and education to raise awareness of the serious effects of mining activities.

EFFICACY OF THE MEASLES-MUMPS-RUBELLA (MMR) VACCINE IN THE REDUCING THE SEVERITY OF COVID-19: AN INTERIM ANALYSIS OF A RANDOMISED CONTROLLED CLINICAL TRIAL

BackgroundCOVID-19 is still a challenge, both with regard to its treatment and to the actual efficacy of the vaccines available to date, especially with the emergence of new variants. We evaluated the efficacy of the measles-mumps-rubella (MMR) vaccine in preventing SARS-CoV-2 infection and severity of COVID-19 in health workers. MethodsThis analysis includes data from one ongoing blinded, randomized, placebo-controlled trial with participants aged 18-60 years were randomly assigned to receive the MMR vaccine or a placebo. The primary efficacy analysis included all participants with a positive nasopharyngeal RT-PCR test since their inclusion. ResultsThe MMR vaccine did not prevent the SARS-CoV-2 infection. Participants in the MMR group, compared with those in the placebo group, had a 48% risk reduction in symptomatic COVID-19 (RR = 0.52; 95% CI: 0.33-0.83; p=0.004) and a 76% risk reduction in COVID-19 treatment (RR = 0.24; 95% CI: 0.06 - 0.88; p = 0.020) with one dose and a 51% risk reduction in COVID-19 symptoms (RR = 0.49; 95% CI: 0.31 - 0.78; p = 0.001) and a 78% risk reduction in COVID-19 treatment (RR = 0.22; 95% CI: 0.06 - 0.82; p = 0.015) with two doses. ConclusionsThis interim analysis of an ongoing clinical trial suggests that compared with a placebo, the vaccine reduces the risk of COVID-19 symptoms and reduces the need for COVID-19 treatment. Clinical Trials RegistryBrazilian Clinical Trials Registry (ReBEC n{degrees} RBR-2xd6dkj - https://ensaiosclinicos.gov.br/rg/RBR-2xd6dkj). HIGHLIGHTSO_LIThe MMR vaccine can stimulate the innate immunity inducing a nonspecific protection against other infections, called heterologous immunity. C_LIO_LIRepeated exposure to the antigen (innate immune response training) results in an extension of the action time of this immune response (innate immune response memory) and consequently in protection against other infections (heterologous immunity) for a longer time. C_LIO_LIThe MMR vaccine has been used by national immunization programs in the world for many years, it is very safe and can be stored and distributed at 2-8{degrees}C, making it particularly suitable for global distribution. C_LIO_LIAmong participants who received at least one dose, compared with those in the placebo group, participants in the MMR group had a significant risk reduction in symptomatic COVID-19 and of cases requiring treatment. C_LIO_LIThe use of MMR vaccine can be useful in several populations in the world that do not have access to the COVID-19 vaccine and in a future epidemic or pandemic as an emergency measure until specific treatments or vaccines for each case are available to the general population. C_LI

Design of Nature Tourism Route in Chimborazo Wildlife Reserve, Ecuador.

The design of new routes is a specific strategy to improve tourism management and to increase the attractiveness of landscape features, promoting activities as a part of sustainable development. This study proposes the design of alternative multi-parameter tourist routes in the Chimborazo Wildlife Reserve based on spatial network analysis implemented in ArcGIS 10.5® software. Tourist interest points were identified and mapped using spatial analysis software, then two routes for bicycles and hiking were defined as being the most efficient, based on the most frequented tourist attractions. The main contribution of this study is the identification of optimal routes for vehicular, bicycling, and hiking traffic through tourist attractions, considering variables such as the time, distance, average circulation speed, road state, and tourist facilities. As a result, two routes were identified. Route one includes 17 tourist attractions, five lodging establishments, four food centers, and one health center. On the other hand, route two includes 11 tourist attractions, two lodging and food establishments, and one health center. The final contribution of this research is to maximize tour satisfaction by presenting new routes of visiting tourist attractions due to the growing demand in the Chimborazo Reserve.

Clinical Outcomes Following Urgent vs. Elective Percutaneous Mitral Valve Repair.

AIM: To examine procedural and clinical outcomes among patients undergoing percutaneous mitral valve repair (PMVR) within an admission for acute-decompensated heart failure (ADHF). METHODS AND RESULTS: Prospective registry of all consecutive patients with symptomatic mitral regurgitation (MR) grade 3+ or 4+ who underwent PMVR our centre and classified in 2 groups: elective group and urgent PMVR group (within the index admission for ADHF). Echocardiographic, procedural and clinical outcomes were compared between groups. 85 patients (median age 77.0 [67.8-83.4] years, 64.7% male) were treated within the recruitment period. Among them, 17 (20%) underwent urgent MitraClip®. Urgent PMVR were at a higher risk for conventional surgery (p = 0.002) and had worse estimated prognosis according to HF risk scores (p < 0.001). Overall technical success was 100%, without differences between groups. At 30 days, no differences were found in mortality, MR reduction and in NYHA functional improvement between groups. Cumulative estimated survival free from all-cause death was 92.9% (82.4% vs. 95.6%), 89.4% (82.4% vs. 91.1%), 76.3% (82.4 vs. 74.9%) at 6 months, 1-year and 2-years, respectively, with no significant differences between urgent or elective PMVR (p = 0.769). CONCLUSION: MitraClip® implantation can be considered as an urgent therapy during admission for ADHF.

Spatial Distribution of Normal Lung Sounds in Healthy Individuals under Varied Inspiratory Load and Flow Conditions.

Respiratory sounds yield pertinent information about respiratory function in both health and disease. Normal lung sound intensity is a characteristic that correlates well with airflow and it can therefore be used to quantify the airflow changes and limitations imposed by respiratory diseases. The dual aims of this study are firstly to establish whether previously reported asymmetries in normal lung sound intensity are affected by varying the inspiratory threshold load or the airflow of respiration, and secondly to investigate whether fixed sample entropy can be used as a valid measure of lung sound intensity. Respiratory sounds were acquired from twelve healthy individuals using four contact microphones on the posterior skin surface during an inspiratory threshold loading protocol and a varying airflow protocol. The spatial distribution of the normal lung sounds intensity was examined. During the protocols explored here the normal lung sound intensity in the left and right lungs in healthy populations was found to be similar, with asymmetries of less than 3 dB. This agrees with values reported in other studies. The fixed sample entropy of the respiratory sound signal was also calculated and compared with the gold standard root mean square representation of lung sound intensity showing good agreement.

Development and Evaluation of a Disease Large Animal Model for Preclinical Assessment of Renal Denervation Therapies.

New-generation catheters-based renal denervation (RDN) is under investigation for the treatment of uncontrolled hypertension (HTN). We assessed the feasibility of a large animal model of HTN to accommodate the human RDN devices. Ten minipigs were instrumented to measure blood pressure (BP) in an awake-state. HTN was induced with subcutaneous 11-deoxycorticosterone (DOCA, 100 mg/kg) implants. Five months after, the surviving animals underwent RDN with the Symplicity® system. Norepinephrine (NE) renal gradients were determined before and 1 month after RDN. Renal arteries were processed for histological (hematoxylin-eosin, Movat pentachrome) and immunohistochemical (S100, tyrosine-hydroxylase) analyses. BP significantly rose after DOCA implants. Six animals died prematurely, mainly from infectious causes. The surviving animals showed stable BP levels after 5 months. One month after RDN, nerve damage was showed in three animals, with impedance drop >10%, NE gradient drop and reduction in BP. The fourth animal showed no nerve damage, impedance drop <10%, NE gradient increase and no change in BP. In conclusion, the minipig model of DOCA-induced HTN is feasible, showing durable effects. High mortality should be addressed in next iterations of this model. RDN may partially offset the DOCA-induced HTN. Impedance drop and NE renal gradient could be markers of RDN success.

Incidence and prognostic implications of late bleeding events after percutaneous mitral valve repair.

OBJECTIVES: MitraClip is an established therapy for patients with mitral regurgitation (MR) that are considered of high-risk or inoperable. However, late bleeding events (BE) after hospital discharge and their impact on prognosis in this cohort of patients have been poorly investigated. Our purpose is to address the incidence, related factors and clinical implications of BE after hospital discharge in patients treated with MitraClip. METHODS: Prospective registry of all consecutive patients (n = 80) who underwent MitraClip implantation in our Institution between June 2014 and December 2017. BE were defined according to MVARC definitions. A combined clinical end-point including admission for heart failure (HF) and all-cause mortality was established to analyze prognostic implications of BE. RESULTS: During a median follow up of 523.5 days, 41 BE were reported in 21 patients. Atrial fibrillation (AF, HR 4.54, CI95% 1.20-17.10) and combined antithrombotic therapy at discharge (HR 3.52, CI95% 1.03-11.34) were independently associated with BE. In the study period, 15 (18.8%) patients died, 20 (25%) were admitted for HF and 29 (36.3%) presented the combined end-point. After multivariable adjustment BE remained independently associated with an adverse outcome (HR 3.80, CI 95% 1.66-8.72). In the subgroup of patients with AF, HAS-BLED score was higher among subjects with BE (3.1 ±â€¯1.3 vs 2.1 ±â€¯0.9, p = 0.003). HAS-BLED score had a significant discrimination power for the occurrence BE (AUC: 0.677 [0.507-0.848]) in this subgroup. CONCLUSIONS: BE are common after MitraClip and are associated with an impaired outcome. Strategies to reduce bleeding events are paramount in this cohort of patients.

Three- and 6-month optical coherence tomographic surveillance following percutaneous coronary intervention with the Angiolite® drug-eluting stent: The ANCHOR study.

BACKGROUND: Pre-clinical results of a novel open-cell, thin strut, durable polymer, laser cut cobalt chromium sirolimus-eluting stent (Angiolite) were promising. Using quantitative optical coherence tomographic (OCT) analyses, we explored the healing characteristics of the Angiolite DES system at 3- and 6-months post implantation. METHODS: A total of 103 patients with de novo coronary lesions underwent percutaneous coronary intervention with the Angiolite DES and were randomized 1:3 into two cohorts for angiographic and OCT follow-up, with 28 and 70 patients returning for 3- or 6-month post-PCI surveillance, respectively. The primary endpoints were the 6-month rates of OCT-derived neointimal proliferation, strut coverage and incomplete strut apposition (ISA), whilst the secondary endpoints were 3-month OCT-derived measures of strut coverage and ISA, as well as 6-month quantitative coronary angiographic-derived measures [late lumen loss (LLL), binary restenosis]. RESULTS: The Angiolite stent was successfully implanted in all patients, without periprocedural complications. At 3- and 6-months follow-up, OCT strut coverage was evident in 86.3% and 83.3% of struts, mean neointimal thickness was 73.7 ± 46.5 µm and 73.9 ± 54.3 µm, mean neo-intimal area obstruction of 5.8% ±10.3% and 4.4% ± 11.3%, and ISA rates were 1.3% ± 7.3% and 1.1% ± 6.2%, respectively. In-stent LLL at 6 months was 0.07 ± 0.37 mm, with a binary in-stent angiographic restenosis rate of 0% without any stent thrombosis, myocardial infarction or cardiovascular death, with 1 patient undergoing ischemia-driven target-lesion revascularization. CONCLUSIONS: At 6 months, the Angiolite DES was safe with high rates of strut coverage, modest degrees of neointimal hyperplasia and very low rates of strut malapposition. These data coupled with the absence of in-stent binary restenosis and a very low 6-month in-stent LLL point towards an efficacious DES. Future studies are required to evaluate its efficacy in broader lesion subsets with longer follow-up.

Seguridad y eficacia de nuevos modelos de stents liberadores de sirolimus con polímero biodegradable en el modelo preclínico / Safety and efficacy of new biodegradable polymer-based sirolimus-eluting stents in a preclinical model

Introducción y objetivos: Los nuevos stents farmacoactivos (SFA), diseñados para solventar las limitaciones de los existentes, han de someterse inicialmente al análisis preclínico. El objetivo es analizar la eficacia y la seguridad de nuevos SFA con polímero biodegradable en comparación con stents convencionales (SC) y SFA comercializados en el modelo de arteria coronaria sana porcina. Métodos: Se implantaron aleatoriamente 101 stents (SC y stents liberadores de sirolimus con polímero biodegradable: 3 formulaciones test [BD1, BD2 y BD3], Orsiro, Biomime y Biomatrix) en las arterias coronarias de 34 cerdos domésticos. Se completó estudio angiográfico e histomorfométrico al mes (n = 83) y a los 3 meses (n = 18). Resultados: Los stents se implantaron en proporción stent/arteria de 1,31 ± 0,21, sin diferencias entre grupos. Al mes, los nuevos stents (BD1, BD2 y BD3) mostraron menos pérdida tardía y reestenosis angiográfica, así como menor área neointimal y reestenosis histológica (p < 0,0005) que los SC. No se observaron diferencias significativas entre los nuevos stents y los SC en endotelización, daño vascular o inflamación; solo se encontró mayor persistencia de fibrina en los nuevos (p = 0,0006). A los 3 meses, todas estas diferencias desaparecieron, excepto una menor área neointimal con el nuevo stent BD1 (p = 0,027). No hubo diferencias en ningún parámetro al mes ni a los 3 meses entre los nuevos stents y los comercializados. Conclusiones: En este modelo preclínico, los nuevos SFA con polímero biodegradable estudiados presentan menos reestenosis que los SC, sin diferencias significativas en seguridad y eficacia respecto a SFA comercializados (AU)

Introduction and objectives New drug-eluting stents (DES) designed to overcome the limitations of existing devices should initially be tested in preclinical studies. Our objective was to analyze the safety and efficacy of new biodegradable polymer-based DES compared with bare-metal stents (BMS) and commercially available DES in a model of normal porcine coronary arteries. Methods: We randomly implanted 101 stents (BMS and biodegradable polymer-based sirolimus-eluting stents: 3 test stent iterations [BD1, BD2, and BD3], Orsiro, Biomime and Biomatrix) in the coronary arteries of 34 domestic pigs. Angiographic and histomorphometric studies were conducted 1 month (n = 83) and 3 months (n = 18) later. Results: The stents were implanted at a stent/artery ratio of 1.31 ± 0.21, with no significant differences between groups. At 1 month, the new test stents (BD1, BD2 and BD3) showed less late loss and angiographic restenosis, as well as lower histologic restenosis and neointimal area (P < .0005), than the BMS. There were no differences in endothelialization, vascular injury, or inflammation between the new test stents and BMS, although the new stents showed higher fibrin deposition (P = .0006). At 3 months, all these differences disappeared, except for a lower neointimal area with the new BD1 stent (P = .027). No differences at any time point were observed between the new test stents and commercially available controls. Conclusions: In this preclinical model, the new biodegradable polymer-based DES studied showed less restenosis than BMS and no significant differences in safety or efficacy vs commercially available DES (AU)

Safety and Efficacy of New Biodegradable Polymer-based Sirolimus-Eluting Stents in a Preclinical Model.

INTRODUCTION AND OBJECTIVES: New drug-eluting stents (DES) designed to overcome the limitations of existing devices should initially be tested in preclinical studies. Our objective was to analyze the safety and efficacy of new biodegradable polymer-based DES compared with bare-metal stents (BMS) and commercially available DES in a model of normal porcine coronary arteries. METHODS: We randomly implanted 101 stents (BMS and biodegradable polymer-based sirolimus-eluting stents: 3 test stent iterations [BD1, BD2, and BD3], Orsiro, Biomime and Biomatrix) in the coronary arteries of 34 domestic pigs. Angiographic and histomorphometric studies were conducted 1 month (n = 83) and 3 months (n = 18) later. RESULTS: The stents were implanted at a stent/artery ratio of 1.31 ± 0.21, with no significant differences between groups. At 1 month, the new test stents (BD1, BD2 and BD3) showed less late loss and angiographic restenosis, as well as lower histologic restenosis and neointimal area (P < .0005), than the BMS. There were no differences in endothelialization, vascular injury, or inflammation between the new test stents and BMS, although the new stents showed higher fibrin deposition (P = .0006). At 3 months, all these differences disappeared, except for a lower neointimal area with the new BD1 stent (P = .027). No differences at any time point were observed between the new test stents and commercially available controls. CONCLUSIONS: In this preclinical model, the new biodegradable polymer-based DES studied showed less restenosis than BMS and no significant differences in safety or efficacy vs commercially available DES.

Titulares sensacionalistas: ¿también en la prensa científica? / Sensationalist headlines: also in the scientific press?

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