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ABSTRACT On May 26, 2021, the European Medical Device Regulation (EU-MDR) entered into effect resulting in a major shift in the requirements for assessment of medical devices in Europe. The EU-MDR Cardiovascular Collaboratory (EU-MCVC) was founded to contribute to the development of faster, more efficient, and more effective pathways for innovation of cardiac medical devices. A registry is an organized system that collects uniform data and evaluates specified outcomes in a population defined by a disease, condition, or exposure. Most registries have been created to improve the quality of care and provide feedback to physicians, hospitals, and health providers. Clinical registries represent an ideal construct for scientific, clinical, and policy-making collaboration. We describe diverse experiences from 5 European countries and address the traditional quality components in clinical trials. Continued collaboration is expected among academics, clinical trialists, patient representatives, regulatory experts, research organizations, registry platforms, regulatory bodies, and industry partners. Data quality is a primary concern and registry leaders need to optimize data quality to become regulatory compliant. A collaborative approach among medical device stakeholders may improve quality of care, reduce costs, and provide faster access to innovative technologies, with the common objective of improving cardiovascular care and outcomes.

RESUMEN El 26 de mayo de 2021 entró en vigor el Reglamento Europeo de Productos Sanitarios (EU-MDR), que supuso un importante cambio en los requisitos de evaluación de los productos sanitarios en Europa. El EU-MDR Cardiovascular Collaboratory (EU-MCVC) se fundó con el fin de contribuir al desarrollo de vías más rápidas, eficientes y eficaces para la innovación de productos sanitarios cardiacos. Un registro es un sistema organizado que recoge datos uniformes y evalúa resultados específicos en una población definida por una enfermedad, afección o exposición. La mayoría de los registros se han desarrollado para mejorar la calidad de la atención y proporcionar información a médicos, hospitales y proveedores de servicios sanitarios. Los registros clínicos representan una construcción ideal para la colaboración científica, clínica y política. Describimos diversas experiencias de 5 países europeos y abordamos los componentes de calidad tradicionales en los ensayos clínicos. Se espera una colaboración continua entre académicos, especialistas en ensayos clínicos, representantes de pacientes, expertos en regulación, organizaciones de investigación, plataformas de registros, organismos reguladores y socios de la industria. La calidad de los datos es una preocupación primordial y los responsables de los registros deben optimizarla para cumplir con la normativa. Un enfoque colaborativo entre las partes interesadas en los dispositivos médicos puede mejorar la calidad de la atención, reducir los costes y proporcionar un acceso más rápido a tecnologías innovadoras, con el objetivo común de mejorar la atención y los resultados cardiovasculares.

El Acceso Abierto (AA) ha sido la piedra angular del movimiento hacia la Ciencia Abierta (CA). Algunas instituciones supranacionales han emitido marcos de desarrollo de la CA, directrices y mandatos seguidos de manera desigual en distintos países y sistemas de educación superior. En este contexto de impulso de la CA, los académicos están adaptándose al nuevo esquema del AA. En este artículo exploramos qué motivaciones determinan la publicación en AA por parte de los académicos españoles, a partir de una encuesta encaminada a conocer las (des)ventajas que contemplan con respecto al AA, con énfasis en sus diferencias sociodemográficas y su percepción de la CA como posibles factores explicativos. Los resultados muestran que, aunque existen diferencias con respecto a la percepción de la CA, éstas aún no se traducen en diferencias estadísticamente significativas en la percepción del AA a través de las variables sociodemográficas consideradas (género, área de conocimiento, etc.).

Background The benefit of patent foramen ovale closure (PFOC) ≤9 months after a cryptogenic stroke has been demonstrated in several randomised clinical trials. There is, however, insufficient data to support PFOC in non-recent cryptogenic strokes.Aims The objective of the study was to evaluate the effectiveness of PFOC in relation to the time since the patient’s most recent cryptogenic cerebrovascular event (CVE) or systemic embolism (SE).Methods We conducted a multicentre, retrospective cohort study with international participation, to assess the results of an early closure (EC,

Introducción: las enfermedades del corazón son la primera causa de muerte en el mundo tanto en el hombre como en la mujer. La presentación de la cardiopatía isquémica varía dependiendo de múltiples factores, entre ellos el género. Materiales y método: estudio observacional, transversal con componente analítico de todos los pacientes ingresados con síndrome coronario agudo en el Hospital Docente Clínico-Quirúrgico Comandante Manuel Fajardo, entre enero del 2016 y diciembre del 2020. Resultados: el género femenino presentó una mediana de edad de 73 (RIC: 62-80), significativamente superior a la del género masculino, con mayor prevalencia de hipertensión arterial y diabetes mellitus (n = 353 y n = 143, respectivamente; p < 0.01). Se identificaron la edad, el valor de la creatinina y el síndrome coronario agudo con elevación del ST como factores desencadenantes de complicaciones cardíacas (RR: 1.01; IC 95%: 1.00-1.07; p = 0.03; RR: 1.01; IC 95%: 1.00-1.02; p = 0.01; y RR: 2.77; IC 95%: 1.31-5.87; p = 0.02, respectivamente). Conclusiones: las mujeres con síndrome coronario agudo presentaron una edad superior a la de los hombres, con mayor prevalencia de hipertensión arterial y diabetes mellitus, mientras las variables predictoras de complicaciones cardiovasculares intrahospitalarias identificadas fueron la edad, el valor de creatinina sérica y el síndrome coronario agudo con elevación del ST.

En torno a la fecha de redacción de esta Página del Editor acabamos de conocer con gran satisfacción que en la última edición del Journal Citation Reports nuestra revista, REC: Interventional Cardiology, ha recibido su primer factor de impacto (FI), siendo este de 1,41. Es sin duda una excepcional noticia, con un valor muy por encima de lo esperado. En anteriores páginas ya hemos manifestado, como otros muchos editores han hecho antes, la excesiva y casi obsesiva dependencia que la publicación médica tiene actualmente con respecto al FI2-6. Todo parece girar en torno a esta métrica tan codiciada y que todas las revistas médicas sin excepción anuncian, sobre todo cuando sube. Los manuscritos publicados en REC: Interventional Cardiology en sus diferentes categorías han tenido de por sí una gran influencia y un notable impacto en la comunidad de cardiología intervencionista de nuestro país y también de otros. De hecho, algunos de los artículos han recibido numerosas citas en las revistas de mayor prestigio internacional. En esta misma línea, los documentos de consenso elaborados por la Asociación de Cardiología Intervencionista de la Sociedad Española de Cardiología (ACI-SEC) han resultado un éxito en difusión e impacto. No obstante, con todos los aspectos críticos que podamos...

The Japanese plum tree (Prunus salicina Lindl.) is mainly cultivated in temperate areas of China and some European countries. Certain amounts of wood (from pruning works) are generated every year from this crop of worldwide commercial significance. The main objective of this work was to value this agricultural woody residue, for which the chemical composition of pruning wood extracts from six Japanese plum cultivars was investigated, and the antiproliferative activity of extracts and pure phenolics present in those extracts was measured. For the chemical characterization, total phenolic content and DPPH radical-scavenging assays and HPLC‒DAD/ESI‒MS analyses were performed, with the procyanidin (−)-ent-epicatechin-(2α→O→7,4α→8)-epicatechin (5) and the propelargonidin (+)-epiafzelechin-(2β→O→7,4β→8)-epicatechin (7) being the major components of the wood extracts. Some quantitative differences were found among plum cultivars, and the content of proanthocyanidins ranged from 1.50 (cv. ‘Fortune’) to 4.44 (cv. ‘Showtime’) mg/g of dry wood. Regarding the antitumoral activity, eight wood extracts and four phenolic compounds were evaluated in MCF-7 cells after 48 h of induction, showing the wood extract from cv. ‘Songold’ and (‒)-annphenone (3), the best antiproliferative activity (IC50: 424 μg/mL and 405 μg/mL, respectively).

Finalist case in the ACCIS 2023 Madrid course A 59-year-old man was admitted to the cardiac intensive care unit (CICU) due to evolved inferior-posterior ST-segment elevation myocardial infarction complicated by cardiogenic shock. Upon arrival, transesophageal echocardiography revealed severe mitral regurgitation (MR) secondary to posterior leaflet restriction (figure 1A,B). After rupture of papillary muscles was ruled out, the patient was transferred to the cath lab, where a 100% thrombotic lesion was observed in the proximal left circumflex artery (figure 1D-E). Due to hypotension, we decided to support the angioplasty with the Impella CP device (Abiomed, United States) (figure 1C). Flow was finally restored (figure 1F). Figure 1. Five days later, the patient was hemodynamically stable with Impella at P6, but developed multiple complications, including acute kidney failure, significant bleeding, and hemolysis. Three-dimensional echocardiography showed MR without changes. At this point, spontaneous improvement of MR seemed unlikely, and the risk of heart transplant or surgery was unacceptable. Finally, we decided to implant a MitraClip (Abbott, United States) supported by Impella. The first MitraClip NTW (Abbott, United States) was placed between P2 and A2, with significant posterior-medial regurgitation (figure 2A-C). The second MitraClip NT (Abbott, United States) was implanted nearby. Residual MR was...

Caso finalista del curso Madrid ACCIS 2023 Varón de 59 años ingresado en la unidad de cuidados intensivos cardiológicos (UCIC) con infarto agudo de miocardio con elevación del segmento ST evolucionado en la región posteroinferior complicado con shock cardiogénico. A su llegada, la ecocardiografía transesofágica reveló la presencia de insuficiencia mitral (IM) grave por restricción del velo posterior (figura 1A-B). Tras descartar la rotura del músculo papilar, se trasladó al paciente a la sala de hemodinámica, donde se objetivó una lesión trombótica del 100% en el segmento proximal de la arteria circunfleja izquierda (figura 1D-E). La presencia de hipotensión obligó a realizar la angioplastia con el dispositivo Impella CP (Abiomed, Estados Unidos) (figura 1C). Finalmente, pudo reestablecerse el flujo (figura 1F). Figura 1. Aunque 5 días después, el paciente permanecía hemodinámicamente estable con el Impella en P6, desarrolló muchas complicaciones tales como daño renal agudo, hemorragia significativa y hemolisis. El ecocardiograma tridimensional confirmó la presencia de una IM sin alteraciones. Llegados a este punto, la mejoría espontánea de la IM parecía improbable y el riesgo de trasplante cardiaco o cirugía, inaceptable, por lo que optamos por implantar un dispositivo MitraClip (Abbott, Estados Unidos) con el sistema de soporte Impella. El primer MitraClip NTW (Abbott,...

Abstract Background Over the past decade, the great impact of agricultural crop diseases has generated considerable economic losses and has compromised the production of edible crops at a time when the world population is only expected to rise, leading to the search for new pest management strategies. Besides that, the environmental impact resulting from the continued use of chemical pesticides has led to the search for natural and sustainable alternatives. One of the existing solutions that currently stands out for its effectiveness is the use of bioactive plant extracts. This study aims to evaluate the antimicrobial activity of propyl propane thiosulfinate (PTS) and propyl propane thiosulfonate (PTSO), two organosulfur compounds (OSCs) derived from Allium cepa, against a wide range of target bacteria and fungi. To this end, various in vitro procedures were conducted as well as soil sanitization tests using sterile substrate inoculated with soil-borne pathogens. In addition, this study also evaluates the pesticidal activity of both compounds through in vitro mortality and repellence tests. Results PTS and PTSO revealed inhibition activity on all the pathogens tested, belonging to different taxonomic groups. Moreover, both significatively reduced the population of bacteria and fungi in soil. The quantification of active substances in soil carried out in parallel to the microbial quantification showed that their use reduces the risk of residue accumulation since they break down quickly when applied. The set of antimicrobial tests performed demonstrated that the antifungal effect of both compounds is higher than the bactericidal effect. Lastly, PTS and PTSO showed a concentration-dependent significant biocidal and repellent effect against aphids. Conclusions The results presented in this work demonstrate that both PTS and PTSO have a significant antimicrobial and pesticidal activity against the great majority of phytopathogens tested, being a promising tool to improve pest management in crops. Graphical Abstract

BackgroundUp to one-fifth of patients continue to have poor quality of life after transcatheter aortic valve implantation (TAVI), with an additional similar proportion not surviving 1 year after the procedure. We aimed to assess the value of a new method based on an integrated analysis of left ventricular outflow tract flow velocity and aortic pressure to predict objective functional improvement and prognosis after TAVI.MethodsIn a cohort of consecutive patients undergoing TAVI, flow velocity–pressure integrated analysis was obtained from simultaneous pressure recordings in the ascending aorta and flow velocity recordings in the left ventricular outflow tract by echocardiography. Objective functional improvement 6 months after TAVI was assessed through changes in a 6-min walk test and NT-proBNP levels. A clinical follow-up was conducted at 2 years.ResultsOf the 102 patients studied, 82 (80.4%) showed objective functional improvement. The 2-year mortality of these patients was significantly lower (9% vs. 44%, p = 0.001). In multivariate analysis, parameter “(Pressure at Vmax − Pressure at Vo)/Vmax” was found to be an independent predictor for objective improvement. The C-statistic was 0.70 in the overall population and 0.78 in the low-gradient subgroup. All echocardiographic parameters and the valvuloarterial impedance showed a C-statistic of

At the time of drafting this Editor’s page, we were thrilled to learn that REC: Interventional Cardiology has received its very first impact factor (IF) of 1.4 in the latest edition of the Journal Citation Reports.1 This is outstanding news and the assigned IF greatly exceeds our expectations. Like many other editors before us, we have previously mentioned on past Editor’s pages the excessive and almost obsessive reliance of the current medical publication world on IF.2-6 Everything seems to revolve around this highly coveted metric, which is made public by all medical journals without exception, especially when it increases. The manuscripts published in the different sections of REC: Interventional Cardiology have significantly impacted the interventional cardiology community in Spain and abroad. Indeed, some of our articles have received numerous citations in top international journals. Likewise, consensus documents drafted by the Interventional Cardiology Association of the Spanish Society of Cardiology (ACI-SEC) have achieved significant dissemination and impact. However, despite the obvious negative aspects of IF, the truth is that it has become the most widely recognized and accepted metric to estimate the value, visibility, and impact of scientific publications. Therefore, if there is anything we would like to highlight in this Editor’s page, it...

ABSTRACT Introduction and objectives: Delayed vascular healing may induce late stent thrombosis. Optical coherence tomography (OCT) is useful to evaluate endothelial coverage. The objective of this study was to compare stent coverage and apposition in non-complex coronary artery lesions treated with durable polymer-coated everolimus-eluting stents (durable-polymer EES) vs biodegradable polymer-coated everolimus-eluting stents (biodegradable-polymer EES) vs polymer-free biolimus-eluting stents (BES) 1 and 6 months after stent implantation. Methods: Prospective, multicenter, non-randomized study that compared the 3 types of DES. Follow-up angiography and OCT were performed 1 and 6 months later. The primary endpoint was the rate of uncovered struts as assessed by the OCT at 1 month. Results: A total of 104 patients with de novo non-complex coronary artery lesions were enrolled. A total of 44 patients were treated with polymer-free BES, 35 with biodegradable-polymer EES, and 25 with durable-polymer EES. A high rate of uncovered struts was found at 1 month with no significant differences reported among the stents (80.2%, polymer-free BES; 88.1%, biodegradable-polymer EES; 82.5%, durable-polymer EES; P = .209). Coverage improved after 6 months in the 3 groups without significant differences being reported (97%, 95%, and 93.7%, respectively; P = .172). Conclusions: In patients with de novo non-complex coronary artery lesions treated with durable vs biodegradable vs polymer-free DES, strut coverage and apposition were suboptimal at 1 month with significant improvement at 6 months.

RESUMEN Introducción y objetivos: A pesar del desarrollo de los stents farmacoactivos, el retraso en la endotelización puede causar trombosis tardía. La tomografía de coherencia óptica puede evaluar la cobertura intimal. El objetivo de este estudio fue comparar la cobertura y la aposición en lesiones coronarias no complejas de 3 tipos de stent: stent de everolimus con polímero persistente, stent de everolimus con polímero bioabsorbible y stent de biolimus sin polímero, a 1 y 6 meses del implante. Métodos: Se diseñó un estudio prospectivo, multicéntrico, no aleatorizado, que comparó 3 stents farmacoactivos. Se realizaron angiografía y tomografía de coherencia óptica a 1 o 6 meses. El objetivo primario fue comparar la cobertura. Resultados: Se incluyeron 104 pacientes con lesiones coronarias de novo no complejas. Se implantó stent sin polímero a 44 pacientes, stent con polímero bioabsorbible a 35 pacientes y stent con polímero persistente a 25 pacientes. Al mes, se observó una alta tasa de struts no cubiertos, sin diferencias significativas entre los grupos (80,2% sin polímero, 88,1% con polímero bioabsorbible y 82,5% con polímero persistente; p = 0,209). La cobertura mejoró a los 6 meses en los 3 stents, sin diferencias significativas entre ellos (97, 95 y 93,7%, respectivamente; p = 0,172). Conclusiones: En los pacientes con lesiones coronarias no complejas tratados con stent con polímero persistente, con polímero bsorbible o sin polímero, la cobertura y la aposición fueron subóptimas a 1 mes del implante, con mejoría significativa a los 6 meses.

Propyl-propane thiosulfonate (PTSO), an antioxidant organosulfur compound present in the genus Allium, has become a potential natural additive for food and feed, as well as a possible biopesticide for pest control in plants. A toxicological assessment is necessary to verify its safety for livestock, consumers, and the environment. As part of the risk assessment of PTSO, this study was designed to explore its potential reproductive toxicity in mice following the OECD 416 guideline. The investigation spans two generations to comprehensively evaluate potential reproductive, teratogenic, and hereditary effects. A total of 80 CD1 mice per sex and generation were subjected to PTSO exposure during three phases (premating, gestation, and lactation). This evaluation encompassed three dose levels: 14, 28, and 55 mg PTSO/kg b.w./day, administered through the feed. No clinical changes or mortality attributed to the administration of PTSO were observed in the study. Some changes in the body weight and food consumption were observed, but not related to sex or in a dose-dependent manner. The two parental generations (F0, F1) exhibited normal reproductive performance, and the offspring (F1 and F2) were born without any abnormalities. The serum sexual hormone levels (progesterone -P-, testosterone -T-, estradiol -E2-, follicular stimulating hormone -FSH-, and luteinizing hormone -LH-) were in a normal range. Although significant changes were observed in the sperm analysis in the case of F0 group, no variation was found for F1 group, and no alterations in fertility were recorded either. The absolute organ weights and relative organ weight/body weight and organ weight/brain weight ratios, and the complete histopathological study, showed no significant alterations in males and females for all the generations considered. Considering all the results obtained, PTSO is not considered a reproductive or developmental toxicant in mice under the assayed conditions. These results support the good safety profile of PTSO for its potential application in the agrifood sector.

Presentamos el caso de un varón de 83 años con estenosis valvular aórtica grave sintomática derivado para implante percutáneo de válvula aórtica (TAVI). El ecocardiograma confirmó la presencia de estenosis valvular aórtica calcificada grave (0,6 cm2) acompañada de anatomía bicúspide (figura 1A). La tomografía computarizada arroja una puntuación de Agatston de 17.727 (figura 1B) y muestra un anillo aórtico con un diámetro de 30 mm, una raíz aórtica dilatada y angulación aórtica > 70 º (figura 1C). también se hizo una aortografía (figura 1D). Durante 60 minutos, 2 operadores experimentados intentaron cruzar la válvula aórtica con una guía empleando catéteres de diferentes curvas y tamaños y varios tipos de guías (con o sin punta en J, hidrofílicas y no hidrofílicas). Luego, la estrategia fue usar un catéter guía coronario izquierdo XB4 de 6 Fr (Cordis, Estados Unidos) para manipular una guía intracoronaria hidrofílica de 0,014 pulgadas Pilot 50 (Abbott, Estados Unidos) que franqueó la válvula aórtica sin problemas (figura 1E). Después, se montó sobre la guía un extensor de catéter de 6 Fr (Deeper, IHT-Cordynamic, España) que se avanzó hacia el ápex del ventrículo izquierdo (figura 1F). Después, la guía intracoronaria se sustituyó por otra guía extra rígida de 0,035 pulgadas,...

Figura 1 This is the case of an 83-year-old man with symptomatic, severe aortic valve stenosis referred for transcatheter aortic valve implantation (TAVI). The echocardiogram revealed the presence of a severely calcified stenotic aortic valve (0.6 cm2) with bicuspid anatomy (figure 1A). The computed tomography scan revealed an Agatston calcium score of 17 727 (figure 1B), a 30 mm aortic annulus diameter, and dilated aortic root and aortic angulation > 70º (figure 1C). Aortography was performed (figure 1D). Crossing the aortic valve with a guidewire for 60 min using catheters of various curves/sizes and several types of guidewires (with or without J-shaped tip, whether hydrophilic or not) was attempted by 2 highly skilled operators. Strategy, then, changed and a XB4 6F left coronary guide catheter (Cordis, United States) was used to manipulate a 0.014 inch hydrophilic Pilot 50 intracoronary guidewire (Abbott, United States) that easily crossed the aortic valve (figure 1E). A 6-Fr guide catheter extension system (Deeper, IHT-Cordynamic, Spain) was mounted on the wire and advanced to the left ventricular apex (figure 1F). Afterwards, the intracoronary guidewire was replaced by a 0.035 inch extra-stiff guidewire by removing both the guide and extension catheter systems (figure 1G). This original new approach took...

In the framework of the Europlanet 2024 Research Infrastructure Transnational Access programme, a terrestrial field campaign was conducted from 29 September to 6 October 2021 in Makgadikgadi Salt Pans (Botswana). The main goal of the campaign was to study in situ the impact of the dust devils (DDs) on the observations made by the radiometer Radiation and Dust Sensor (RDS), which is part of the Mars Environmental Dynamics Analyzer instrument, on board NASA’s Mars 2020 Perseverance rover. Several DDs and dust lifting events caused by non-vortex wind gusts were detected using the RDS, and the different impacts of these events were analyzed in the observations. DD diameter, advection velocity, and trajectory were derived from the RDS observations, and then, panoramic videos of such events were used to validate these results. The instrument signal variations produced by dust lifting (by vortices or wind gusts) in Makgadikgadi Pans are similar to those observed on Mars with the RDS, showing the potential of this location as a Martian DD analog.

Dust devils are common on Mars and understanding their dynamics is important to gain insights about the meteorology of the planet. Here, the authors show characteristics of a Martian dust devil and its sound from Perseverance rover multi-sensor data combined with modelling.

En el momento de escribir esta página se cumplen 4 años desde el inicio de REC: Interventional Cardiology. Han sido años muy intensos en general debido a la pandemia de la COVID-19 y, en particular, por las incertidumbres y los retos que supone arrancar una nueva publicación médica en el entorno actual, tan competitivo en todos los aspectos. Con todo ello, creemos firmemente que estos 4 años han resultado muy satisfactorios para nuestra joven revista, más incluso de lo que habríamos aventurado en sus orígenes. Podemos decir que se ha logrado su consolidación y se la ha dotado de un contenido de calidad de forma estable, y eso a pesar de las limitaciones inherentes a una publicación que todavía carece de algunas de las indexaciones y métricas de impacto, que tan atractivas son para los autores. En este sentido hemos de reseñar, como se detallará más adelante, que son ya varias las indexaciones logradas y estamos muy cerca de alcanzar las más relevantes. Esta revista es el órgano oficial de la Asociación de Cardiología Intervencionista de la Sociedad Española de Cardiología (ACI-SEC), y por ello es, debe ser, su principal medio de expresión. En esta línea, la publicación de varios documentos de...

At the time of writing, 4 years have gone by since REC: Interventional Cardiology made its publishing appearance for the first time. Overall, these have been very intense years due to the COVID-19 pandemic. In particular due to the uncertainty surrounding the birth of a new medical journal in today’s competitive setting. Still, we strongly believe that these 4 years have been more profitable for our young journal than we could have ever anticipated. Although we still are in the process of being included in certain citation indices, which will give us the impact metrics so attractive to authors, our journal has become established and publishes quality content on a regular basis. In this sense, and as we will be seeing next, REC: Interventional Cardiology has already been included in some citation indices and we are very close to being accepted in the most relevant ones. REC: Interventional Cardiology is the official journal of the Interventional Cardiology Association of the Spanish Society of Cardiology (ACI-SEC) and stands tall as its official true means of expression. We can see that the decision to publish several consensus documents was correct as the thousands of visits received demonstrate.1,2 A couple more documents are in...

RESUMEN La estadística bayesiana valora de forma probabilística cualquier fuente de incertidumbre asociada a un estudio estadístico y utiliza el teorema de Bayes para actualizar, de manera secuencial, la información generada en las diferentes fases del estudio. Las características de la inferencia bayesiana la hacen especialmente útil para el tratamiento de datos cardiológicos procedentes de estudios experimentales u observacionales que contienen diferentes fuentes de variabilidad y complejidad. En este trabajo se presentan los conceptos básicos de la estadística bayesiana relativos a la estimación de parámetros y cantidades derivadas, predicción de nuevos datos y contrastes de hipótesis; estos últimos en el contexto de la selección de modelos o teorías.

ABSTRACT Bayesian statistics assesses probabilistically all sources of uncertainty involved in a statistical study and uses Bayes’ theorem to sequentially update the information generated in the different phases of the study. The characteristics of Bayesian inference make it particularly useful for the treatment of cardiological data from experimental or observational studies including different sources of variability, and complexity. This paper presents the basic concepts of Bayesian statistics associated with the estimation of parameters and derived quantities, new data prediction, and hypothesis testing. The latter in the context of model or theory selection.

Sr. Editor: En los estudios longitudinales en cardiología, el objetivo principal suele ser el tiempo hasta ciertos eventos adversos (EA), con el objetivo de identificar factores de riesgo o la eficacia de un tratamiento. Tradicionalmente se han empleado los composite endpoints, en concreto los EA cardiovasculares mayores (MACE) en sus diferentes versiones, que presentan la gran ventaja de aumentar la potencia de los estudios y de simplificar el análisis, pero dificultan la interpretación de los resultados1 y además presentan otras limitaciones, como otorgar el mismo peso a cada evento o utilizar únicamente la información sobre el primer evento. Por ello, en los últimos años ha crecido la preocupación por la actualización de estos métodos2. El problema de analizar datos de estudios longitudinales con varios EA de interés se presta de manera natural a ser abordado con modelos multiestado, ya que permiten plantear modelos con una estructura compleja de relaciones entre la aparición de los diferentes eventos teniendo en cuenta todos los datos disponibles para cada paciente, además de proporcionar información sobre el tiempo esperado y la probabilidad de aparición de cada EA, estableciendo su dependencia de los factores de riesgo o de las características del tratamiento3. Las principales ventajas de los modelos...

To the Editor, The main objective of longitudinal studies conducted in cardiology is often time-to-adverse events (AE) to identify possible risk factors or the efficacy of treatment. Traditionally, composite endpoints have been used, often major adverse cardiovascular events (MACE) in their different versions. Their great advantage is to increase the statistical power of the studies and simplify analysis. However, they complicate the interpretation of results1 and have other limitations like giving the same weight to every event or using the information of the index event only. Therefore, over the last few years, concern has been growing on whether these methods should be updated.2 The problem with data analysis in longitudinal studies with several AE of interest can be approached using multi-state models in a natural way since they create models with a complex structure of relations during the appearance of different events and account for all the data available from every patient. Also, they provide information on time expected and probability of appearance of each AE, and establish their interdependence with risk factors or with the characteristics of treatment.3 The main advantages of multi-state models compared to other models commonly used are shown on table 1. Table 1. Comparison between the most commonly...

ABSTRACT Introduction and objectives: Coronary artery aneurysms are a complex situation. Our main objective is to describe the frequency of use of covered stents (grafts) for their management, as well as to characterize their long-term results compared to drug-eluting stents. Methods: Ambispective observational study with data from the International Coronary Artery Aneurysm Registry (CAAR) (NCT-02563626). Only patients who received a stent-graft or a drug-eluting stent where the aneurysm occurred were selected. Results: A total of 17 patients received, at least, 1 stent-graft while 196 received 1 drug-eluting in the aneurysmal vessel. Male predominance, a higher rate of dyslipidemia, a past medical history of coronary artery disease, previously revascularized coronary artery disease, and giant aneurysms were reported in the stent-graft cohort. The independent predictive variables of the composite endpoint of all-cause mortality, heart failure, unstable angina, reinfarction, stroke, systemic embolism, bleeding or any aneurysmal complications at the median follow-up of 38 months were suggestive of the existence of connective tissue diseases (HR, 5.94; 95%CI, 1.82-19.37), left ventricular dysfunction ≤ 55% (HR, 1.84; 95%CI, 1.09-3.1), and an acute indication for heart catheterization (HR, 2.98; 95%CI, 1.39-6.3). The use of stent-grafts was not associated with the occurrence of more composite endpoints (23.5% vs 29.6%; P = .598). Conclusions: The use of stent-grafts to treat coronary aneurysms is feasible and safe in the long-term. Randomized clinical trials are needed to decide what the best treatment is for these complex lesions. Keywords: Coronary aneurysm. Registry. Stent. Stent graft. Angioplasty.

RESUMEN Introducción y objetivos: Los aneurismas coronarios son una situación compleja. Planteamos como objetivo principal describir la frecuencia de utilización de stents recubiertos (grafts) para su tratamiento y caracterizar sus resultados a largo plazo en comparación con stents farmacoactivos. Métodos: Estudio observacional ambispectivo, con información procedente del Registro Internacional de Aneurismas Coronarios (CAAR) (NCT-02563626). Se seleccionaron los pacientes que recibieron un stent-graft o un stent farmacoactivo en la zona del aneurisma. Resultados: Un total de 17 pacientes recibieron al menos un stent-graft y 196 un stent farmacoactivo en la zona aneurismática. Se observa un predominio del sexo masculino y una mayor frecuencia de dislipemia, antecedentes de coronariopatía, enfermedad coronaria revascularizada previamente y aneurismas gigantes en la cohorte de stent-graft. Como variables independientes predictoras del desarrollo del evento combinado (muerte por cualquier causa, insuficiencia cardiaca, angina inestable, reinfarto, ictus, embolia sistémica, sangrado o cualquier complicación en el aneurisma), tras una mediana de seguimiento de 38 meses, destacaron la existencia de conectivopatías (hazard ratio [HR] = 5,94; intervalo de confianza del 95% [IC95%], 1,82-19,37), la disfunción del ventrículo izquierdo ≤ 55% (HR = 1,84; IC95%, 1,09-3,1) y la indicación aguda del cateterismo índice (HR = 2,98; IC95%, 1,39-6,3). El uso de stent-grafts comparado con el de stents farmacoactivos no se asoció al desarrollo de más eventos combinados (23,5 frente a 29,6%; p = 0,598). Conclusiones: El uso de stents recubiertos en aneurismas coronarios es factible y seguro a largo plazo. Se necesitan estudios clínicos aleatorizados para decidir el mejor tratamiento de este tipo de lesiones complejas.

BackgroundA non-negligible rate of patients undergoing transcatheter aortic valve replacement (TAVR) do not report symptomatic improvement or even die in the short-midterm. We sought to assess the degree of objective functional recovery after TAVR and its prognostic implications and to develop a predictive model.MethodsIn a cohort of patients undergoing TAVR, a prospective evaluation of clinical, anatomical, and physiological parameters was conducted before and after the procedure. These parameters were derived from echocardiography, non-invasive analysis of arterial pulse waves, and cardiac tomography. Objective functional improvement 6 months after TAVR was assessed using a 6-min walk test and nitro-terminal pro-brain natriuretic peptide (NT-proBNP) levels. The derived predictive model was prospectively validated in a different cohort. A clinical follow-up was conducted at 2 years.ResultsAmong the 212 patients included, objective functional improvement was observed in 169 patients (80%) and subjective improvement in 187 (88%). Patients with objective functional improvement showed a much lower death rate at 2 years (9% vs. 31% p = 0.0002). Independent predictors of improvement were as follows: mean aortic gradient of ≥40 mmHg, augmentation index75 of ≥45%, the posterior wall thickness of ≤12 mm, and absence of atrial fibrillation. A simple integer-based point score was developed (GAPA score), which showed an area under the curve of 0.81 for the overall cohort and 0.78 for the low-gradient subgroup. In a validation cohort of 216 patients, these values were 0.75 and 0.76, respectively.ConclusionA total of 80% of patients experienced objective functional improvement after TAVR, showing a significantly lower 2-year mortality rate. A predictive score was built that showed a good discriminative performance in overall and low-gradient populations.

RESUMEN Introducción y objetivos: Los pacientes con estenosis en el tronco coronario izquierdo (TCI) han sido excluidos de los ensayos que apoyan la no inferioridad del cociente de presiones en el índice diastólico instantáneo sin ondas (iFR) respecto a la reserva fraccional de flujo (RFF) en la toma de decisiones sobre revascularización coronaria. El presente estudio propone valorar de manera prospectiva la concordancia entre los dos índices en lesiones del TCI y validar el valor de corte del iFR de 0,89 para su uso clínico. Métodos: Registro multicéntrico nacional, prospectivo, observacional, con la inclusión de 300 pacientes consecutivos con lesiones intermedias (estenosis angiográfica 25-60%) en el TCI. Se realizará un estudio con guía de presión y determinación de RFF e iFR. En caso de resultado concordante negativo (RFF > 0,80 / iFR > 0,89), no se realizará tratamiento; en caso de resultado concordante positivo (RFF ≤ 0,80 / iFR ≤ 0,89), se realizará revascularización; en caso de resultado discordante (RFF > 0,80 / iFR ≤ 0,89 o RFF ≤ 0,80 / iFR > 0,89), se realizará estudio con ecocardiografía intravascular y se considerará diferir la revascularización si el área luminal mínima es > 6 mm2. El criterio de valoración clínico primario será la incidencia del combinado de muerte cardiovascular, infarto no mortal relacionado con la lesión del TCI o necesidad de revascularización de la lesión del TCI a los 12 meses. Conclusiones: La demostración de la seguridad clínica en la toma de decisiones del iFR en pacientes con lesiones intermedias en el TCI tendría un impacto clínico importante y justificaría su uso sistemático para la decisión del tratamiento en estos pacientes de potencial alto riesgo. Registrado en ClinicalTrials.gov (identificador: NCT03767621).

ABSTRACT Introduction and objectives: Patients with left main coronary artery (LMCA) stenosis have been excluded from the trials that support the non-inferiority of the instantaneous wave-free ratio (iFR) compared to the fractional flow reserve (FFR) in the decision-making process of coronary revascularization. This study proposes to prospectively assess the concordance between the two indices in LMCA lesions and to validate the iFR cut-off value of 0.89 for clinical use. Methods: National, prospective, and observational multicenter registry of 300 consecutive patients with intermediate lesions in the LMCA (angiographic stenosis, 25% to 60%. A pressure gudiewire study and determination of the RFF and the iFR will be performed: in the event of a negative concordant result (FFR > 0.80/iFR > 0.89), no treatment will be performed; in case of a positive concordant result (FFR ≤ 0.80/iFR ≤ 0.89), revascularization will be performed; In the event of a discordant result (FFR> 0.80/iFR ≤ 0.89 or FFR ≤ 0.80/iFR> 0.89), an intravascular echocardiography will be performed and revascularization will be delayed if the minimum lumen area is > 6 mm2. The primary clinical endpoint will be a composite of cardiovascular death, LMCA lesion-related non-fatal infarction or need for revascularization of the LMCA lesion at 12 months. Conclusions: Confirm that an iFR-guided decision-making process in patients with intermediate LMCA stenosis is clinically safe and would have a significant clinical impact. Also, justify its systematic use when prescribing treatment in these potentially high-risk patients. Registered at ClinicalTrials.gov ( Identifier: NCT03767621).

Simvastatin (SIM) is a potent lipid-lowering drug used to control hyper-cholesterolemia and prevent cardiovascular diseases. SIM presents low oral bioavailability (5%) because of its low aqueous solubility. In this work, polyelectrolyte complexes (PEC) are developed with different chitosan (CS) and carboxymethylcellulose (CMC) ratios that will allow for an increase in the SIM dissolution rate (2.54-fold) in simulated intestinal medium (pH 4.5). Scanning Electron Microscopy (SEM) images revealed highly porous structures. The changes between both complexes, PEC-SIM:CS:CMC (1:1:2) and (1:2:1), were related to the relaxation of the polymer chains upon absorption of the dissolution medium. Fourier-transform infrared spectroscopy (FTIR), differential scanning calorimetry (DSC) and powder X-ray diffraction (XRPD) studies were used to evaluate the polymer/polymer and drug/polymer interactions on the different PEC-SIM:CS:CMC ratios. In addition, the PEC-SIM:CS:CMC (1:2:1) complex exhibited a high ratio of protonated amino groups (NH3+) and an increase in intramolecular hydrogen bonds, which were correlated with a high expansion of the interpolymer chains and an increase in the SIM dissolution rate. Different kinetic models such as zero-order, first-order, Higuchi and Korsmeyer–Peppas were studied to evaluate the influence of CS/CMC ionic interactions on the ability to improve the release rate of poorly soluble drugs.

En la página del editor publicada el pasado año destacábamos el carácter naciente de la revista y celebrábamos su primer año de andadura. También señalábamos su rápida y eficaz respuesta en los momentos iniciales y confusos de la crisis de la COVID-19, al publicar en un tiempo récord los documentos de consenso elaborados por la Asociación de Cardiología Intervencionista de la Sociedad Española de Cardiología (ACI-SEC) en colaboración con otras asociaciones. Una clara muestra de esta acertada actuación es el artículo que describía el efecto de la pandemia de la COVID-19 sobre la actividad asistencial en cardiología intervencionista en España, que ha recibido numerosas citas en las publicaciones de mayor prestigio1. Durante este último periodo anual se han publicado artículos especiales elaborados por la ACI-SEC, o por sus grupos de trabajo, como el de actualización de las recomendaciones sobre requisitos y equipamiento en cardiología intervencionista2 y el de la valoración de la función endotelial y provocación de vasoespasmo coronario3. Estos documentos son de gran interés para toda la comunidad cardiológica a afectos clínicos, pero también administrativos. Los principales protagonistas de esta trayectoria tan satisfactoria han sido los autores, tanto los que nos han enviado sus manuscritos bajo los diferentes formatos como los...

Last year’s Editor’s page discussed the emerging quality of our publication that celebrated its first anniversary at that time. Also, the fast and effective response of the journal at the early and confusing times of the COVID-19 crisis should be noted, publishing—in record time—consensus documents written by the Interventional Cardiology Association of the Spanish Society of Cardiology (ACI-SEC) in collaboration with other medical societies. A clear example of this was the article describing the effects of the COVID-19 pandemic on the healthcare situation in interventional cardiology in Spain that has been cited numerous times in some of today’s most prestigious medical journals.1 Over the last year, special articles elaborated by the ACI-SEC or by some of its working groups have been published such as “Update on requirements and equipment in interventional cardiology”,2 and the article on the assessment of endothelial function and spasm provocation test.3 Both documents are of great interest to the entire cardiovascular community, not only from the clinical but also from the administrative point of view. The main protagonists of such a satisfactory trajectory have been the authors, both those who have submitted their manuscripts in different formats as well as those invited by the editorial committee to write...

Background: In developed countries, health care delivery in dermatology is hampered by the low availability of dermatologists. Objective: To analyze the feasibility of a teledermatology-based action plan to provide initial dermatologic care in areas with low availability of dermatologists. Methods: A cross-sectional study describing the feasibility and cost of a 12-month action plan based on a store-and-forward teledermatology (TD) connecting primary care centers and a TD center. Teleconsultations from patients complaining of any cutaneous condition were included. The primary outcome measure was the percentage of patients not referred to the local dermatologist. Results: Among the total of 15,523 teleconsultations attended in the TD-based action plan, 3360 (21.65%) required a face-to-face visit with a local dermatologist. In 32.32% (n = 5017) of the cases, a therapeutic and follow-up plan report was issued. The most common conditions managed were melanocytic nevi (15.63%, n = 2426), followed by seborrheic keratosis (14.89%, n = 2312), and actinic keratosis (8.65%, n = 1342). The average response time was 14.52 days (95% CI 14.35-15.23). The additional total investment in this action plan was $142,681.01, with a unit cost of 9.20$/patient. Limitations: Noncontrolled study. Conclusions: Experienced dermatologists working with store-and-forward TD can deliver a fast and effective response in health care areas with access limitations.

Abstract Central aortic blood pressure could be helpful in the evaluation of patients with aortic stenosis (AS). The SphygmoCor XCEL device estimates central blood pressure (BP) measurement with its easy‐to‐use, operator‐independent procedure. However, this device has not been properly validated against invasive measurement in patients with severe AS. We evaluated the relationship between cuff‐brachial BP, transfer function‐estimated and invasively measured central aortic pressure in patients with severe AS before and after transcatheter aortic valve replacement (TAVR). Agreement between techniques was analyzed and, according to the ARTERY Society recommendations, the minimum acceptable error was a mean difference ± SD ≤5 ± ≤8 mm Hg. A total of 94 patients with AS undergoing TAVR had simultaneous non‐invasive and invasive measurements of central BP before and after the procedure. Before TAVR central systolic BP was in average slightly underestimated, though with wide variability, when using the default calibration of brachial‐cuff SBP (mean difference ± SD, −3 ± 15 mm Hg), and after TAVR the degree of underestimation increased (mean difference ± SD, −9 ± 13 mm Hg). The agreement tended to improve for those patients with low aortic gradient stenosis compared to those with high gradient at baseline (mean difference ± SD, −2 ± 11 mm Hg vs. −4 ± 17, respectively, p = .3). The cuff‐brachial systolic BP yielded numerically lower degree of agreement and weaker correlation with invasive measurements than SphygmoCor XCEL. In patients with severe AS the SphygmoCor XCEL cuff device, despite showing strong correlation, does not meet the ARTERY Society accuracy criteria for non‐invasive measurement of central SBP.