Challenges of developing and executing a multi-site registry for a novel device with evolving indications for use.

BACKGROUND: The introduction of new technologies in endoscopy has been met with uncertainty, skepticism, and lack of standardization or training parameters, particularly when disruptive devices or techniques are involved. The widespread availability of a novel endoscopic suturing device (OverStitch™) for tissue apposition has enabled the development of applications of endoscopic suturing. METHODS: The American Gastroenterological Association partnered with Apollo Endosurgery to develop a registry to capture in a pragmatic non-randomized study the safety, effectiveness, and durability of endoscopic suturing in approximating tissue in the setting of bariatric revision and fixation of endoprosthetic devices. RESULTS: We highlight the challenges of the adoption of novel techniques by examining the process of developing and executing this multicenter registry to assess real-world use of this endoscopic suturing device. We also present our preliminary data on the safety and effectiveness of the novel device as it is applied in the treatment of obesity. CONCLUSIONS: The Prospective Registry for Trans-Orifice Endoscopic Suturing Applications (ES Registry) was an effective Phase 4, postmarketing registry aimed at capturing pragmatic, real-world use of a novel device. These findings serve to solidify the role of endoscopic suturing in clinical practice.

Dual activation profile of monocytes is associated with protection in Mexican patients during SARS-CoV-2 disease.

The COVID-19 pandemic, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has been one of the most catastrophic diseases observed in recent years. It has reported nearly 550 million cases worldwide, with more than 6.35 million deaths. In Mexico, an increased incidence and mortality of this disease were observed, where the immune response has been involved in the magnitude and severity. A critical version of the disease is accompanied by hyperinflammatory responses, with cytokine and defective cellular responses. A detailed understanding of the role of molecules and cells in the immune response during COVID-19 disease may help to generate effective protection mechanisms, improving those we already have. Here we analyzed blood samples obtained from patients at the Hospital Regional de Alta Especialidad de Ixtapaluca (HRAEI), Mexico, which were classified according to living guidance for clinical management of COVID-19 by the World Health Organization: asymptomatic, mild, severe, and critical disease. We observed increased interleukin (IL)-6 levels and a T-CD8+ and T-CD4+ cell reduction correlated with the critical disease version. Importantly, here, we described a significant reduction of CD11b+CD45highCD14low monocytes during severe disease, which displayed a non-classical profile, expressing IL-10, transforming growth factor (TGF)-ß, and indoleamine 2,3-dioxygenase (IDO)1 molecule. Moreover, CD11b+CD45highCD14low monocytes obtained from infected one-dose vaccinated patients (Pfizer® vaccine) who suffered minimal symptoms showed simultaneously a dual classical and no-classical profile expressing pro- and anti-inflammatory cytokines. These results suggest that blood monocytes expressing a dual pro- and anti-inflammatory profile might be a predictive marker for protection in the Mexican population during COVID-19 disease. KEY POINTS : • Exacerbated immune response is associated with COVID-19 severe disease. • Dual monocyte activation profile is crucial for predicting protection during COVID-19. • Vaccination is crucial to induce the dual activation profile in monocytes.

Revisión y análisis de las pandemias más devastadoras de la humanidad: de la antigüedad hasta la actualidad

Introduccion. Recently our world has sunk into a pandemic, owing to a new virus of the Coronaviridae family called SARS-CoV-2, better known as "COVID-19". Our generation had never known a pandemic of such proportions. This brings up the questions of how were other pandemics tackled in the past, what kind of therapy was used at the time and what scientific knowledge was available then. Objective. To describe the big pandemics in human history. Show the beliefs or perceptions concerning the origin of the disease when it happened. And run historically through the therapies applied and the scientific knowledge about the pandemics. Methodology. A systematic revision of the bibliography on the main pandemics in human history. The searching was carried out in the databases of Scopus, PubMed and Lilacs. Besides, a manual revision of literature in grey was implemented with the aim at adding other potentially valid studies for revision. Inclusion criteria: published articles in Spanish or English between 2007 and 2020, should they be available for full reading. Results. As a result of our search a total of 39 articles were found, most of them were bibliographic revisions and reference from official bodies because of the historic nature of this piece of work. Discussion. Twenty epidemics have been counted. Among these, we will point out those that have yielded the highest figures in morbidity and mortality, as follows: The Black Death, Smallpox, The Spanish Flu, Measles, HIV, and the most recent one, COVID-19. Conclusions. We can understand how therapies affected the succession of such pandemics, positively or negatively, and what influence they had on the development of science and research. Introducción: Recientemente, nuestro mundo se ha sumido en una pandemia, tras la aparición de un nuevo coronavirus, el SARS-CoV-2. Nuestra generación no había conocido una pandemia de tales dimensiones. Esto nos hace preguntarnos cómo se afrontaban en el pasado, cuáles eran las medidas terapéuticas y con qué conocimientos científicos se contaba. Objetivos: Describir las grandes pandemias de la historia de la humanidad;Reflejar las creencias o percepciones en cuanto al origen de la enfermedad en cada época;y recorrer históricamente las medidas terapéuticas y los conocimientos científicos en las pandemias. Metodología: Revisión sistemática de la literatura mediante análisis narrativo sobre las principales pandemias de la historia de la humanidad, realizada en las bases de datos Scopus, PubMed y Lilacs. Además, se llevó a cabo una revisión manual de literatura gris. Criterios de inclusión: artículos en idioma castellano o inglés, publicados entre 2007-2020, con acceso completo. Resultados: Se obtuvieron un total de 39 referencias, en su mayoría revisiones bibliográficas e informes de organismos oficiales, debido al carácter histórico del presente trabajo. Discusión: Se han contabilizado una veintena de epidemias y pandemias. De ellas, vamos a detallar las que han reportado mayores cifras de morbimortalidad: la peste negra, la viruela, la gripe española, el sarampión, el VIH y la más reciente COVID-19. Conclusiones: Podemos entender la forma en la que las medidas terapéuticas históricas afectaron positiva o negativamente la sucesión de dichas pandemias, así como la influencia que han tenido en el desarrollo de la ciencia y la investigación.