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El presente artículo pretende contribuir al estudio de la novela española contemporánea a partir del examen de uno de los fenómenos literarios más fecundos de la última década: la llamada novela de la crisis. Para ello, examinamos la genealogía del término —que comenzó a usarse a partir de 2013 a raíz de la publicación de En la orilla de Rafael Chirbes—, así como su recorrido durante el decenio de los años diez, tanto a nivel académico como divulgativo. Asimismo, comparamos, desde una perspectiva crítica, las distintas propuestas de definición y clasificación que se han elaborado sobre esta controvertida etiqueta hasta ahora.

ABSTRACT Introduction and objectives: The Interventional Cardiology Association of the Spanish Society of Cardiology (ACI-SEC) and the Interventional Working Group of the Spanish Society of Pediatric Cardiology (GTH-SECPCC) present their annual activity report for 2022. Methods: All Spanish centers with catheterization laboratories and interventional activity in congenital heart diseases were invited to participate. Data were collected online and analyzed by an external company, together with the members of the ACI-SEC and the GTH-SECPCC. Results: A total of 22 centers participated (19 public and 3 private). Interventional data on adult congenital diseases contributed by another 99 hospitals to the Registry of Cardiac Catheterization and Interventional Cardiology of the ACI-SEC in 2022 were incorporated into the analysis. A total of 1141 diagnostic studies (4.3% more than in 2021) and 2508 interventional catheterizations (61.5% more than in 2020) were registered. The most frequent procedures were atrial septal defect closure (1135 cases), percutaneous closure of patent ductus arteriosus (262 cases), and pulmonary branch artery angioplasty (234 cases). The most significant increases in volume were related to balloon aortic valvuloplasty (48.9%), atrial septal defect closure (45.2%), and ventricular septal defect closure (40.7%). Interventional procedures were successful in 97.6%, with major procedural complications occurring in 1.4% and in-hospital mortality in 0.2%. Conclusions: This report is the third publication of the Spanish Cardiac Catheterization in Congenital Heart Diseases Registry. Both diagnostic and interventional procedures substantially increased, particularly in balloon aortic valvuloplasty, atrial septal defect closure, and ventricular septal defect closure. Most interventional techniques continue to demonstrate excellent safety and effectiveness outcomes.

RESUMEN Introducción y objetivos: La Asociación de Cardiología Intervencionista de la Sociedad Española de Cardiología (ACI-SEC) y el Grupo de Trabajo de Hemodinámica de la Sociedad Española de Cardiología Pediátrica y Cardiopatías Congénitas (GTH-SECPCC) presentan su informe anual de actividad hemodinámica en cardiopatías congénitas correspondiente al año 2022. Métodos: Se invitó a participar a los centros españoles con laboratorio de hemodinámica y actividad intervencionista en cardiopatías congénitas. La recogida de datos se realizó mediante un cuestionario telemático. Una empresa externa analizó los resultados, que fueron revisados por miembros de la ACI-SEC y el GTH-SECPCC. Resultados: Participaron en el registro 22 centros (19 públicos y 3 privados). Se incorporaron al análisis los datos de intervencionismo en cardiopatías congénitas del adulto aportados por otros 99 hospitales al Registro de Hemodinámica y Cardiología Intervencionista de la ACI-SEC del año 2022. Se registraron 1.141 estudios diagnósticos (un 4,3% más que en 2021) y 2.508 cateterismos intervencionistas (un 61,5% más que en 2021). Las técnicas con mayor casuística fueron el cierre de defectos interauriculares (1.135 casos), el cierre de ductus arterioso (262 casos) y la angioplastia de ramas pulmonares (234 casos). El incremento más significativo se comunicó en la valvuloplastia aórtica (48,9%), el cierre de defectos interauriculares (45,2%) y el cierre de comunicación interventricular (40,7%). La tasa de éxito en los procedimientos intervencionistas fue del 97,6%, con una tasa de complicaciones mayores del 1,4 % y una mortalidad intrahospitalaria del 0,2%. Conclusiones: El presente trabajo es la tercera publicación del Registro Español de Intervencionismo en Cardiopatías Congénitas. Se ha comunicado un aumento muy significativo de la mayoría de los procedimientos terapéuticos, destacando el incremento de la valvuloplastia aórtica, del cierre de defectos interauriculares y del cierre de comunicación interventricular. Todas las técnicas intervencionistas han comunicado excelentes datos de seguridad y eficacia.

The decreasing well-being among doctoral candidates, coupled with a high prevalence of distress problems, is a topic of increasing concern in the field of higher education and research policy. The present study aimed to replicate, implement, and evaluate the effectiveness of The Third Half, a multi-component psychoeducational program in doctoral students. To address the limitations of the pilot study, we conducted a non-randomized controlled study using a repeated measures pre-post design with a total of 97 participants (Mage = 32.5; SD = 8.23), of whom 26 participated in the experimental group. Results showed that Third Half program participants reported significant decreases in indicators of negative affect (F = 4.01; p = .04) and anxiety (F = 4.95; p = .02) compared to the general control group; in the matched sample analysis (n = 20) significant decreases were found in indicators of negative affect (F = 4.72; p = .03), anxiety (F = 4.09; p

Background Despite tremendous therapeutic advancements, a significant proportion of coronary artery disease patients suffer from refractory angina pectoris, that is, quality-of-life-compromising angina that is non-manageable with established pharmacological and interventional treatment options. Adenoviral vascular endothelial growth factor-DΔNΔC (AdVEGF-D)-encoding gene therapy (GT) holds promise for the treatment of refractory angina.Methods ReGenHeart is an investigator-initiated, multicentre, randomised, placebo-controlled and double-blinded phase 2 clinical trial that aims to study the safety and efficacy of intramyocardially administered angiogenic AdVEGF-D GT for refractory angina. Patients will be randomised in a 2:1 ratio and blocks of six to receive either AdVEGF-D or placebo. Primary endpoints are improvements in functional capacity assessed with the 6 min walking test and angina symptoms with Canadian Cardiovascular Society class after 6 month follow-up. Secondary endpoints are improvements in myocardial perfusion assessed with either positron emission tomography or single-photon emission CT after 6 month follow-up and functional capacity and angina symptoms after 12 months. In addition, changes in the quality of life, the use of angina medication and the incidence of major adverse cardiac and cerebrovascular events will be evaluated.Conclusions The phase 2 ReGenHeart trial will provide knowledge of the safety and efficacy of AdVEGF-D GT to ameliorate symptoms in refractory angina patients, extending and further testing positive results from the preceding phase 1/2a trial.

Resumen: Introducción y objetivos: En cirugía protésica de rodilla y cadera está claro que aún no se ha desarrollado una técnica de cierre estandarizada óptima. A nivel local no existen datos que describan la práctica quirúrgica habitual en cierre de herida. El objetivo de este trabajo es analizar el cierre de herida en cirugía protésica a través de una encuesta sobre una muestra representativa a nivel nacional y así obtener información sobre el contexto del cierre en España. Material y método: Se conforma un grupo ad hoc de especialistas en cirugía protésica. El grupo de expertos, posterior al análisis de la literatura, elabora un cuestionario de 32 preguntas cerradas de opción múltiple, divididas en los siguientes bloques: hemostasia, cierre quirúrgico de la herida y apósitos. Resultados: Un total de 471 cirujanos respondieron la encuesta de forma completa y con información suficiente para efectuar el análisis descriptivo; 79% cree que el ácido tranexámico (ATX) puede influir en la disminución de tasa de infección de sitio quirúrgico; 96% cree que el tipo de cierre profundo a nivel de la artrotomía podría influir en los resultados y complicaciones tras prótesis de cadera y/o rodilla; 85% cree que el tipo de cierre superficial a nivel subcutáneo puede influir en los resultados y complicaciones tras prótesis de cadera y/o rodilla; 64% de los cirujanos utiliza la terapia de presión negativa incisional de simple uso para el tratamiento de las complicaciones de la herida quirúrgica (seromas, drenaje prolongado, dehiscencias). Conclusiones: Existe en nuestro entorno una alta variabilidad en el cierre de la herida y una baja inversión en formación sobre este tema. Los autores recomiendan a las diferentes sociedades científicas la inversión de recursos para mejorar la formación en dicho campo y reducir el porcentaje de cirujanos que se consideran inadecuadamente formados, así como adaptar las técnicas de cierre a aquellas consideradas patrón oro según la evidencia. Abstract: Background and objective: In orthopedic surgery, it is clear that an optimal standardized closure technique has not yet been developed. Locally, there are no objective data describing the standard surgical practice in wound closure. The aim of this study is to analyze the clinical practice of surgical wound closure in orthopedic surgery by means of a survey of a representative local sample and thus obtain information on the context of closure in Spain. Method: an ad hoc group of specialists in orthopedic surgery and traumatology was formed. The group of experts, after analyzing the literature, developed a questionnaire of 32 closed multiple-choice questions divided into the following blocks: hemostasis, surgical wound closure (deep, superficial, and cutaneous), and dressings. Results: A total of 471 surgeons responded to the survey completely and with sufficient information to perform the descriptive analysis. 79% believe that ATX can influence the decrease in surgical site infection rate. 96% believe that the type of deep closure at the level of the arthrotomy could influence outcomes and complications after hip and/or knee replacements. 85% believe that the type of shallow closure at the subcutaneous level may influence outcomes and complications after hip and/or knee replacement. 64% of surgeons use single-use incisional negative pressure therapy for the treatment of surgical wound complications (seroma, prolonged drainage, dehiscence). Conclusions: There is a high level of variability in wound closure in our setting and a low level of training on the subject. The authors recommend that the different scientific societies invest resources to improve training in this field and reduce the percentage of surgeons who are considered inadequately trained, as well as adapting closure techniques to those considered gold standard according to the evidence.

Background: Longitudinal changes in gut microbiome and inflammation may be involved in the evolution of atherosclerosis after an acute coronary syndrome (ACS). We aimed to characterize repeated profiles of gut microbiota and peripheral CD4+ T lymphocytes during the first year after an ACS, and to address their relationship with atherosclerotic plaque changes. Methods: Over one year we measured the microbiome, peripheral counts of CD4+ T populations and cytokines in 67 patients shortly after a first ACS. We compared baseline measurements to those of a matched population of 40 chronic patients. A subgroup of 20 ACS patients underwent repeated assessment of fibrous cap thickness (FCT) of a non-culprit lesion. Results: At admission, ACS patients showed gut dysbiosis compared with the chronic group, which was rapidly reduced and remained low at 1-year. Also, their Th1 and Th2 CD4+ T counts were increased but decreased over time. The CD4+ T counts were related to ongoing changes in gut microbiome. Unsupervised clustering of repeated CD4+ Th0, Th1, Th2, Th17 and Treg counts in ACS patients identified two different cell trajectory patterns, related to cytokines. The group of patients following a high-CD4+ T cell trajectory showed a one-year reduction in their FCT [net effect = -24.2 µm; p = 0.016]. Conclusions: Patients suffering an ACS show altered profiles of microbiome and systemic inflammation that tend to mimic values of chronic patients after 1-year. However, in one-third of patients, this inflammatory state remains particularly dysregulated. This persistent inflammation is likely related to plaque vulnerability as evident by fibrous cap thinning (Clinical Trial NCT03434483).

RESUMEN Introducción y objetivos: Se describen los resultados del Registro Radcong-21 del Grupo de Trabajo de Hemodinámica de la Sociedad Española de Cardiología Pediátrica y Cardiopatías Congénitas con el objetivo de analizar los datos, establecer parámetros de referencia actualizados y compararlos con otros registros. Métodos: Registro multicéntrico, observacional, transversal y retrospectivo de pacientes con cardiopatías congénitas tratados con cateterismo cardiaco en 2021. Cada sala de hemodinámica remite los últimos 100 casos realizados hasta enero de 2022. Análisis descriptivo de variables antropomórficas, procedimientos (agrupados por tipo y riesgo estimado de radiación [RER]), características técnicas y parámetros dosimétricos. Revisión adicional de todos los valores fuera del intervalo de confianza del 95% de la mediana. Resultados: Se analizaron 1.090 procedimientos en 11 salas de hemodinámica de 10 centros hospitalarios. De los pacientes, el 22,8% fueron < 1 año, el 60,7% entre 1 y 18 años, y el 16,4% > 18 años. Los valores del producto dosis-área (PDA)/kg y del PDA/kg/fluoroscopia fueron muy similares independientemente del tipo de sala, al igual que ocurre con la edad, el peso y el grupo RER en la mayor parte de las salas pediátricas. El PDA/kg fue superior en los grupos RER I y III comparado con otros países con registros y programas de mejora activos en este campo (un 78 y un 8,3%, respectivamente). Conclusiones: Se obtienen datos representativos de los parámetros dosimétricos por edad y procedimientos en los cateterismos cardiacos congénitos en España en el año 2021. El PDA/kg es el que tiene menor dispersión en la muestra total. Existen áreas de mejora en comparación con otros países con programas de optimización.

ABSTRACT Introduction and objectives: The results of the Radcong-21 Registry of the Spanish Society of Pediatric Cardiology and Congenital Heart Disease Working Group on Hemodynamics are described to analyze data, establish updated reference parameters, and compare them to other registries. Methods: Retrospective, cross-sectional, observational, multicenter registry of patients with congenital heart disease undergoing cardiac catheterization in 2021. Each cath lab sent the last 100 cases performed prior to January 2022. A descriptive analysis was conducted of anthropomorphic variables, procedural (grouped by type and radiation exposure categories [REC]) and technical characteristics, and dosimetric parameters with additional review of all values outside the 95%CI of the median. Results: A total of 1090 procedures performed in 11 cath lab of 10 hospital centers were analyzed. Age distribution: 22.8% 18 years. In dose area product (DAP)/Kg and DAP/Kg/fluoroscopy, the distribution was very similar regardless of the type of cath lab as is the case with most pediatric patients in terms of age, weight, and REC group. The DAP/Kg was higher in the REC I and III groups compared to other countries with registries and improvement programs in this area (78% and 8,3%, respectively). Conclusions: Representative data of dosimetric parameters by age and procedures in congenital cardiac catheterizations were obtained in Spain back in 2021. DAP/Kg is the parameter with the lowest dispersion in the sample. There is room for improvement compared to other countries with optimization programs in this area.

RESUMEN Introducción y objetivos: La Asociación de Cardiología Intervencionista de la Sociedad Española de Cardiología (ACI-SEC) y el Grupo de Trabajo de Hemodinámica de la Sociedad Española de Cardiología Pediátrica y Cardiopatías Congénitas (GTH-SECPCC) presentan su informe anual de actividad hemodinámica en cardiopatías congénitas correspondiente al año 2021. Métodos: Se invitó a participar a los centros españoles con laboratorio de hemodinámica y actividad intervencionista en cardiopatías congénitas. La recogida de datos fue telemática y su análisis lo efectuó una empresa externa junto con miembros de la ACI-SEC y el GTH-SECPCC. Resultados: Participaron 16 centros (15 públicos y 1 privado) que acumulan 34 salas de hemodinámica con actividad en cardiopatías congénitas, 7 (20,5%) de ellas con dedicación exclusiva a pacientes pediátricos. Se registraron 1.094 estudios diagnósticos (5,1% más que en 2020) y 1.553 cateterismos intervencionistas (6,4% más que en 2020). Las técnicas más frecuentes fueron el cierre de comunicación interauricular (336 casos), la angioplastia de ramas pulmonares (231 casos) y el cierre de ductus (228 casos). Respecto al año anterior se incrementaron significativamente las técnicas de implantación de válvulas percutáneas (29,3%), cierre de ductus (20,6%) y angioplastia aórtica (12,8%). La tasa de éxito en los procedimientos intervencionistas fue del 95%, con una tasa de complicaciones mayores del 2,7% y una mortalidad intrahospitalaria del 0,2%. Conclusiones: Este trabajo es la segunda publicación del Registro Español de Intervencionismo en Cardiopatías Congénitas. Se ha constatado un aumento significativo de los procedimientos diagnósticos y terapéuticos, destacando el incremento en la implantación de válvulas percutáneas, el cierre de ductus y la angioplastia aórtica. La mayoría de las técnicas intervencionistas siguen demostrando excelentes datos de seguridad y eficacia.

ABSTRACT Introduction and objectives: This is the 2021 annual activity report from the Interventional Cardiology Association of the Spanish Society of Cardiology (ACI-SEC), and the Interventional Working Group of the Spanish Society of Pediatric Cardiology (GTH-SECPCC). Methods: All Spanish centers with cath lab capabilities and interventional activity in congenital heart diseases were invited to participate. Data were collected online, analyzed by an external company, and ACI-SEC and GTH-SECPCC members. Results: A total of 16 centers participated—15 public and 1 private—including 34 cath labs with experience in congenital heart diseases, 7 of them (20.5%) exclusively dedicated to pediatric patients. A total of 1094 diagnostic studies (4.5% more than 2020) and 1553 interventional catheterizations (5.8% more than 2020) were registered. The most common procedures were atrial septal defect closure (336 cases), pulmonary branch artery angioplasty (231 cases), and percutaneous closure of the patent ductus arteriosus (228 cases). Interventional procedures were considered successful in 95% of the cases with rates of major procedural complication and in-hospital mortality of 2.7% and 0.2%, respectively. Conclusions: This is the second Spanish Cardiac Catheterization in Congenital Heart Diseases Registry report. A significant increase of diagnostic and interventional procedures was reported with a special increase of percutaneous valve implantation, ductus arteriosus closure, and aortic angioplasty. Most interventional techniques continue to demonstrate excellent safety and efficacy outcomes.

Rifampicin is one of the mainstays in treating staphylococcal prosthetic joint infection (PJI). However, discontinuation due to intolerance, drug interactions, and adverse events is common. Two-stage revision surgery remains the gold standard, with the number of revision arthroplasties steadily increasing. This study aims to evaluate the effectiveness and safety of a novel two-stage revision protocol for staphylococcal prosthetic joint infection (PJI) utilizing bone cement spacers loaded with multiple high doses of antibiotics. Additionally, it seeks to analyze outcomes in patients ineligible for rifampicin treatment. A retrospective review of 43 cases of staphylococcal hip and knee prosthetic joint infections (PJIs) from 2012 to 2020 was conducted. In all instances, a commercial cement containing 1 g of gentamicin and 1 g of clindamycin, augmented with 4 g of vancomycin and 2 g of ceftazidime, was employed to cast a spacer manually after thorough surgical debridement. We report an eradication rate of 82%, with no significant differences observed (p = 0.673) between patients treated with (84%, n = 19) and without rifampicin (79%, n = 24). There were no disparities in positive culture rates (7%), spacer replacement (18%), or survival analysis (p = 0.514) after an average follow-up of 68 months (range 10–147) in the absence of systemic toxicity and surgical complications superimposable to those previously reported. In conclusion, two-stage revision with local high doses of ceftazidime, vancomycin, gentamicin, and clindamycin demonstrates high effectiveness in treating staphylococcal PJIs. Notably, systemic rifampicin does not influence the outcomes. This protocol, with multiple high doses of antibiotics loaded into the bone cement spacer, is presented as a viable and safe alternative for patients unsuitable for rifampicin treatment.

Abstract Prosthetic joint infection (PJI) is one of the most devastating complications of orthopedic surgery. However, not all patients are equally at the risk of severe infection. The incidences of PJI vary with the host and surgery-related risk factors. It is now generally accepted that some important medical comorbidities may predispose the patients to a high risk of PJI. Time-consuming and invasive surgical procedures, such as revision arthroplasties, are also associated with a high incidence of PJI, presumably due to the increased risk of surgical site contamination. Effective infection-preventing strategies should begin with identifying and optimizing the patients at a high risk of infection prior to surgery. Optimizing the operating room environment and antibiotic prophylaxis are also essential strategies that help minimize the overall incidence of infection in orthopedic surgery. The ideal antibiotic prophylaxis is still under debate, and discussions have emerged about whether variations or adjustments to the standard protocol are justified in patients at a high risk of infection. This also includes evaluating the possible benefits and risks of using high-dose dual antibiotic-loaded bone cement instead of low-dose single antibiotic-loaded bone cement in arthroplasty. This review summarizes the evidence showing that the combination of two local antibiotics in bone cement exerts a strong and longer-lasting antimicrobial effect against PJI-associated pathogens. This conclusion is consistent with the preliminary clinical studies showing a low incidence of PJI in high-risk patients undergoing cemented hemiarthroplasty, cemented revision, and primary arthroplasty if dual ALBC is used. These results may encourage clinicians to consolidate this hypothesis in a wider clinical range.

RESUMEN Introducción y objetivos: La Asociación de Cardiología Intervencionista de la Sociedad Española de Cardiología (ACI-SEC) y el Grupo de Trabajo de Hemodinámica de la Sociedad Española de Cardiología Pediátrica y Cardiopatías Congénitas (GTH-SECPCC) presentan el informe de actividad hemodinámica en cardiopatías congénitas de 2020, año de inicio de la pandemia de la enfermedad coronavírica de 2019 (COVID-19). Métodos: Se invitó a participar a los centros españoles con laboratorio de hemodinámica y actividad intervencionista en cardiopatías congénitas. La recogida de datos se realizó telemáticamente; una empresa externa, junto con miembros de la ACI-SEC y el GTH-SECPCC, los analizó. Resultados: Participaron 16 centros (todos públicos), que acumulan 30 salas de hemodinámica con actividad en cardiopatías congénitas, 7 (23,3%) de ellas con dedicación exclusiva a pacientes pediátricos. Se registraron 1.046 estudios diagnósticos y 1.468 cateterismos intervencionistas. Los procedimientos terapéuticos fueron exitosos en el 94,9%, con una tasa de complicaciones mayores del 2% y una mortalidad del 0,1%. Las técnicas más frecuentes fueron el cierre de comunicación interauricular (377 casos), la angioplastia pulmonar (244 casos) y el cierre de ductus arterioso (199 casos). Conclusiones: El presente trabajo representa la primera publicación del Registro Español de Intervencionismo en Cardiopatías Congénitas. La casuística registrada está condicionada por la pandemia de la COVID-19. Los cateterismos diagnósticos siguen teniendo un papel relevante en esta actividad. Para la mayoría de las técnicas intervencionistas se han reportado excelentes datos de seguridad y eficacia.

ABSTRACT Introduction and objectives: The Interventional Cardiology Association of the Spanish Society of Cardiology (ACI-SEC) and the Spanish Society of Pediatric Cardiology Working Group on Interventional Cardiology (GTH-SECPCC) introduce their annual activity report for 2020, the starting year of the pandemic of coronavirus disease (COVID-19). Methods: All Spanish centers with cath labs and interventional activity in congenital heart diseases were invited to participate. Data were collected online, and analyzed by an external company together with members from the ACI-SEC and the GTH-SECPCC. Results: A total of 16 centers participated (all of them public) including 30 cath labs experienced in the management of congenital heart diseases, 7 of them (23.3%) dedicated exclusively to pediatric patients. A total of 1046 diagnostic studies, and 1468 interventional cardiac catheterizations were registered. The interventional procedures were considered successful in 93.4% of the cases with rates of major procedural complications and mortality of 2%, and 0.1%, respectively. The most frequent procedures were atrial septal defect closure (377 cases), pulmonary angioplasty (244 cases), and the percutaneous closure of the patent ductus arteriosus (199 cases). Conclusions: This report is the first publication from the Spanish Cardiac Catheterization in Congenital Heart Diseases Registry. The data recorded are conditioned by the COVID-19 pandemic. Diagnostic cardiac catheterization still plays a key role in this field. Most interventional techniques have reported excellent security and efficacy rates.

Abstract Background The appropriate degree of constraint in knee prosthetic revision is unknown, necessitating the use of the lowest possible constraint. This study aimed to compare the long-term clinical and survival results of revision with rotation hinge knee (RHK) VS constrained condylar constrained knee (CCK) implants. Methods Overall, 117 revision case were prospectively reviewed and dividing into two groups based on the degree of constraint used, using only one prosthetic model in each group (61 CCK vs 56 RHK). All implants were evaluated for a minimum of 10 years. Survival of both implants at the end of follow-up, free from revision for any cause, aseptic loosening, and septic cause was compared. Results Better results were seen with use of the RHK in joint ranges of (p = 0.023), KSCS (p = 0.015), KSFS (p = 0.043), and KOOS (p = 0.031). About 22.2% of the cases required repeat surgery (11.7% RHK vs 29.6% CCK, p = 0.023). Constrained condylar implants had a significantly lower survival rates than rotating hinge implants (p = 0.005), due to a higher aseptic loosening rate (p = 0.031). Conclusion Using a specific RHK design with less rotational constraint has better clinical and survival outcomes than implants with greater rotational constraint, such as one specific CCK.

AimsCardiopoietic cells, produced through cardiogenic conditioning of patients' mesenchymal stem cells, have shown preliminary efficacy. The Congestive Heart Failure Cardiopoietic Regenerative Therapy (CHART-1) trial aimed to validate cardiopoiesis-based biotherapy in a larger heart failure cohort.Methods and resultsThis multinational, randomized, double-blind, sham-controlled study was conducted in 39 hospitals. Patients with symptomatic ischaemic heart failure on guideline-directed therapy (n = 484) were screened; n = 348 underwent bone marrow harvest and mesenchymal stem cell expansion. Those achieving > 24 million mesenchymal stem cells (n = 315) were randomized to cardiopoietic cells delivered endomyocardially with a retention-enhanced catheter (n = 157) or sham procedure (n = 158). Procedures were performed as randomized in 271 patients (n = 120 cardiopoietic cells, n = 151 sham). The primary efficacy endpoint was a Finkelstein-Schoenfeld hierarchical composite (all-cause mortality, worsening heart failure, Minnesota Living with Heart Failure Questionnaire score, 6-min walk distance, left ventricular end-systolic volume, and ejection fraction) at 39 weeks. The primary outcome was neutral (Mann-Whitney estimator 0.54, 95% confidence interval [CI] 0.47-0.61 [value > 0.5 favours cell treatment], P = 0.27). Exploratory analyses suggested a benefit of cell treatment on the primary composite in patients with baseline left ventricular end-diastolic volume 200-370 mL (60% of patients) (Mann-Whitney estimator 0.61, 95% CI 0.52-0.70, P = 0.015). No difference was observed in serious adverse events. One (0.9%) cardiopoietic cell patient and 9 (5.4%) sham patients experienced aborted or sudden cardiac death.ConclusionThe primary endpoint was neutral, with safety demonstrated across the cohort. Further evaluation of cardiopoietic cell therapy in patients with elevated end-diastolic volume is warranted.

Abstract The concept that cell‐based repair of myocardial injury might be possible was introduced almost two decades ago; however, the field of cardiovascular reparative medicine has been criticized as translation to clinically effective approaches has been slow. The recent retraction of a series of papers has further impacted perception of this area of research. As researchers, clinicians, and teachers in this field, we felt it incumbent to critically appraise the current state of cardiac cell repair, determine what can be learned from past mistakes, and formulate best practices for future work. This special communication summarizes an introspective assessment of what has fallen short, how to prevent similar issues, and how the field might best move forward in the service of science and patients.

The use of additive manufacturing or 3D printing in biomedicine has experienced fast growth in the last few years, becoming a promising tool in pharmaceutical development and manufacturing, especially in parenteral formulations and implantable drug delivery systems (IDDSs). Periprosthetic joint infections (PJIs) are a common complication in arthroplasties, with a prevalence of over 4%. There is still no treatment that fully covers the need for preventing and treating biofilm formation. However, 3D printing plays a major role in the development of novel therapies for PJIs. This review will provide a deep understanding of the different approaches based on 3D-printing techniques for the current management and prophylaxis of PJIs. The two main strategies are focused on IDDSs that are loaded or coated with antimicrobials, commonly in combination with bone regeneration agents and 3D-printed orthopedic implants with modified surfaces and antimicrobial properties. The wide variety of printing methods and materials have allowed for the manufacture of IDDSs that are perfectly adjusted to patients’ physiognomy, with different drug release profiles, geometries, and inner and outer architectures, and are fully individualized, targeting specific pathogens. Although these novel treatments are demonstrating promising results, in vivo studies and clinical trials are required for their translation from the bench to the market.

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Abstract Background Greater trochanteric pain syndrome encompasses a range of causes of lateral hip pain including greater trochanteric bursitis, tendinopathy and tears of the gluteus minimus and medius, and lateral snapping hip (LSH). Surgical options for LSH range from open surgery to endoscopic surgery, including a diamond-shaped cut or a simple transversal release to gluteus maximus tendon release. Resection of an area of proximal iliotibial band (ITB) and step-cut or z-plasty lengthening have not proven superior to transverse release of the ITB. Therefore, making a complete and effective transverse cut guided by ultrasound may represent a potential advance over endoscopic surgery. Purpose In this case series study, we describe how to perform proximal release of the ITB guided by ultrasound. Methods The surgical technique—either z-plasty or transverse section of the ITB—was first validated on 10 cadaver specimens and then used in clinical practice. Fourteen patients (5 males and 9 females) were operated from 2014 to 2018. Mean age was 43 years (29–62). Results The snap resolved in all patients, as verified actively during the surgical procedure as the patient has only local anesthesia. The VAS score for sports activity improved from 7 (5–9) before surgery to 0 (0–2) after 1 year. The HSS score improved from 58 points (47–72) to 96 at 1–2 years. There were no complications other than minor hematomas nor recurrences. Conclusion Ultrasound-guided release of the LSH is a novel surgical option with encouraging results in patients for whom conservative protocols have failed. It can be performed under local anesthesia in an outpatient setting with minimal aggressiveness. It is relatively easy, quick, and painless; no stitches are required. Weight bearing is immediate, and patients usually need crutches for only 2–3 days. Although complete recovery may take 3 months, the rehabilitation protocol is fast and painless.