Implantation of a double allogeneic human engineered tissue graft on damaged heart: insights from the PERISCOPE phase I clinical trial

Reparación cardíaca; Ingeniería de tejidos cardíacos; Infarto de miocardioReparació cardíaca; Enginyeria de teixits cardíacs; Infart de miocardiCardiac repair; Cardiac tissue engineering; Myocardial infarctionBackground In preclinical studies, the use of double allogeneic grafts has shown promising results in promoting tissue revascularization, reducing infarct size, preventing adverse remodelling and fibrosis, and ultimately enhancing cardiac function. Building upon these findings, the safety of PeriCord, an engineered tissue graft consisting of a decellularised pericardial matrix and umbilical cord Wharton's jelly mesenchymal stromal cells, was evaluated in the PERISCOPE Phase I clinical trial (NCT03798353), marking its first application in human subjects. Methods This was a double-blind, single-centre trial that enrolled patients with non-acute myocardial infarction eligible for surgical revascularization. Seven patients were implanted with PeriCord while five served as controls. Findings Patients who received PeriCord showed no adverse effects during post-operative phase and one-year follow-up. No significant changes in secondary outcomes, such as quality of life or cardiac function, were found in patients who received PeriCord. However, PeriCord did modulate the kinetics of circulating monocytes involved in post-infarction myocardial repair towards non-classical inflammation-resolving macrophages, as well as levels of monocyte chemoattractants and the prognostic marker Meteorin-like in plasma following treatment. Interpretation In summary, the PeriCord graft has exhibited a safe profile and notable immunomodulatory properties. Nevertheless, further research is required to fully unlock its potential as a platform for managing inflammatory-related pathologies.This work was supported in part by grants from MICINN (SAF2017-84324-C2-1-R); Instituto de Salud Carlos III (ICI19/00039 and Red RICORS-TERAV RD21/0017/0022, and CIBER Cardiovascular CB16/11/00403) as a part of the Plan Nacional de I + D + I, and co-funded by ISCIII-Subdirección General de Evaluación y el Fondo Europeo de Desarrollo Regional (FEDER) and AGAUR (2021-SGR-01437)

Extracorporeal membrane oxigenation in COVID-19 patients: Results of the ECMO-COVID Registry of the Spanish Society of Cardiovascular and Endovascular Surgery

Oxigenación con membrana extracorpórea; COVID-19; Insuficiencia cardiacaExtracorporeal membrane oxygenation; COVID-19; Heart failureOxigenació amb membrana extracorpòria; COVID-19; Insuficiència cardíacaIntroducción y objetivos La oxigenación con membrana extracorpórea (ECMO) ha resultado ser una opción terapéutica en los pacientes con insuficiencia respiratoria o cardiaca severa por COVID-19. Las indicaciones y manejo de estos pacientes están aún por determinar. Nuestro objetivo es evaluar los resultados de la terapia ECMO en pacientes con COVID-19 incluidos en un registro prospectivo e intentar optimizar los resultados. Métodos En marzo de 2020 se inició un registro multicéntrico anónimo prospectivo de pacientes con COVID-19 tratados mediante ECMO veno-arterial (V-A) o veno-venosa (V-V). Se registraron las variables clínicas, analíticas y respiratorias preimplante, datos de implante y evolución de la terapia. El evento primario fue la mortalidad hospitalaria de cualquier causa y los eventos secundarios fueron la recuperación funcional y el evento combinado de recuperación funcional y mortalidad de cualquier causa a partir de los 3 meses de seguimiento tras el alta. Resultados Se analizó a un total de 365 pacientes procedentes de 25 hospitales, 347 V-V y 18 V-A (edad media de 52,7 y 49,4 años, respectivamente). Los pacientes con ECMO V-V fueron más obesos, presentaban menos fracaso orgánico diferente al pulmonar y precisaron menos terapia inotrópica previa al implante. El 33,3% y el 34,9% de los pacientes con ECMO V-A y V-V, respectivamente, fueron dados de alta del hospital (p = NS) y la mortalidad fue similar, del 56,2% y 50,9% de los casos respectivamente, la inmensa mayoría durante la ECMO y sobre todo por fracaso multiorgánico. El 14,0% (51 pacientes) permanecían ingresados. El seguimiento medio fue de 196 ± 101,7 días. En el análisis multivariante, resultaron protectores de evento primario en pacientes con ECMO V-V el peso corporal (OR 0,967; IC 95%: 0,95-0,99; p = 0,004) y la procedencia del propio hospital (OR 0,48; IC 95%: 0,27-0,88; p = 0,018), mientras que la edad (OR 1,063; IC 95%: 1,005-1,12; p = 0,032), la hipertensión arterial (3,593; IC 95%: 1,06-12,19; p = 0,04) y las complicaciones en ECMO globales (2,44; IC 95%: 0,27-0,88; p = 0,019), digestivas (OR 4,23, IC 95%: 1,27-14,07; p = 0,019) y neurológicas (OR 4,66; IC 95%: 1,39-15,62; p = 0,013) fueron predictores independientes de mortalidad. El único predictor independiente de aparición de los eventos secundarios resultó el momento de seguimiento del paciente. Conclusiones La terapia con ECMO permite supervivencias hospitalarias hasta del 50% en pacientes con COVID-19 grave. La edad, la hipertensión arterial y las complicaciones en ECMO son los predictores de mortalidad hospitalaria en pacientes con ECMO V-V. Un mayor peso corporal y la procedencia del propio hospital son factores protectores. La recuperación funcional solo se ve influida por el tiempo de seguimiento transcurrido tras el alta. La estandarización de los criterios de implante y manejo del paciente con COVID grave mejoraría los resultados y la futura investigación clínica.Background and aim: COVID-19 patients with severe heart or respiratory failure are potential candidates for extracorporeal membrane oxygenation (ECMO). Indications and management of these patients are unclear. Our aim is to describe the results of a prospective registry of COVID-19 patients treated with ECMO. Methods: An anonymous prospective registry of COVID-19 patients treated with veno-arterial (V-A) or veno-venous (V-V) ECMO was created on march 2020. Clinical, analytical and respiratory preimplantation variables, implantation data and post-implantation course data were recorded. The primary endpoint was all cause in-hospital mortality. Secondary events were functional recovery and the combined endpoint of mortality and functional recovery in patients followed at least 3 months after discharge. Results: Three hundred and sixty-six patients from 25 hospitals were analyzed, 347 V-V ECMO and 18 V-A ECMO patients (mean age 52.7 and 49.5 years respectively). Patients with V-V ECMO were more obese, had less frequently organ damage other than respiratory failure and needed less inotropic support; Thirty three percent of V-A ECMO and 34.9% of V-A ECMO were discharged (P = NS). Hospital mortality was non-significantly different, 56.2% versus 50.9% respectively, mainly during ECMO therapy and mostly due to multiorgan failure. Other 51 patients (14%) remained admitted. Mean follow-up was 196 ± 101.7 days (95%CI: 170.8-221.6). After logistic regression, body weight (OR 0.967, 95%CI: 0.95-0.99, P = 0.004) and ECMO implantation in the own centre (OR 0.48, 95%CI: 0.27-0.88, P = 0.018) were protective for hospital mortality. Age (OR 1.063, 95%CI: 1.005-1.12, P = 0.032), arterial hypertension (3.593, 95%CI: 1.06-12.19, P = 0.04) and global (2.44, 95%CI: 0.27-0.88, P = 0.019), digestive (OR 4,23, 95%CI: 1.27-14.07, P = 0.019) and neurological (OR 4.66, 95%CI: 1.39-15.62, P = 0.013) complications during ECMO therapy were independent predictors of primary endpoint occurrence. Only the post-discharge day at follow-up was independent predictor of both secondary endpoints occurrence. Conclusions: Hospital survival of severely ill COVID-19 patients treated with ECMO is near 50%. Age, arterial hypertension and ECMO complications are predictors of hospital mortality, and body weight and implantation in the own centre are protective. Functional recovery is only predicted by the follow-up time after discharge. A more homogeneous management of these patients is warranted for clinical results and future research optimization

Risk factors for infections caused by carbapenem-resistant Enterobacterales: an international matched case-control-control study (EURECA)

Cases were patients with complicated urinary tract infection (cUTI), complicated intraabdominal (cIAI), pneumonia or bacteraemia from other sources (BSI-OS) due to CRE; control groups were patients with infection caused by carbapenem-susceptible Enterobacterales (CSE), and by non-infected patients, respectively. Matching criteria included type of infection for CSE group, ward and duration of hospital admission. Conditional logistic regression was used to identify risk factors. Findings Overall, 235 CRE case patients, 235 CSE controls and 705 non-infected controls were included. The CRE infections were cUTI (133, 56.7%), pneumonia (44, 18.7%), cIAI and BSI-OS (29, 12.3% each). Carbapenemase genes were found in 228 isolates: OXA-48/like, 112 (47.6%), KPC, 84 (35.7%), and metallo-beta-lactamases, 44 (18.7%); 13 produced two. The risk factors for CRE infection in both type of controls were (adjusted OR for CSE controls; 95% CI; p value) previous colonisation/infection by CRE (6.94; 2.74-15.53; <0.001), urinary catheter (1.78; 1.03-3.07; 0.038) and exposure to broad spectrum antibiotics, as categorical (2.20; 1.25-3.88; 0.006) and time-dependent (1.04 per day; 1.00-1.07; 0.014); chronic renal failure (2.81; 1.40-5.64; 0.004) and admission from home (0.44; 0.23-0.85; 0.014) were significant only for CSE controls. Subgroup analyses provided similar results. Interpretation The main risk factors for CRE infections in hospitals with high incidence included previous coloni-zation, urinary catheter and exposure to broad spectrum antibiotics

NEOTROPICAL CARNIVORES: a data set on carnivore distribution in the Neotropics

Mammalian carnivores are considered a key group in maintaining ecological health and can indicate potential ecological integrity in landscapes where they occur. Carnivores also hold high conservation value and their habitat requirements can guide management and conservation plans. The order Carnivora has 84 species from 8 families in the Neotropical region: Canidae; Felidae; Mephitidae; Mustelidae; Otariidae; Phocidae; Procyonidae; and Ursidae. Herein, we include published and unpublished data on native terrestrial Neotropical carnivores (Canidae; Felidae; Mephitidae; Mustelidae; Procyonidae; and Ursidae). NEOTROPICAL CARNIVORES is a publicly available data set that includes 99,605 data entries from 35,511 unique georeferenced coordinates. Detection/non-detection and quantitative data were obtained from 1818 to 2018 by researchers, governmental agencies, non-governmental organizations, and private consultants. Data were collected using several methods including camera trapping, museum collections, roadkill, line transect, and opportunistic records. Literature (peer-reviewed and grey literature) from Portuguese, Spanish and English were incorporated in this compilation. Most of the data set consists of detection data entries (n = 79,343; 79.7%) but also includes non-detection data (n = 20,262; 20.3%). Of those, 43.3% also include count data (n = 43,151). The information available in NEOTROPICAL CARNIVORES will contribute to macroecological, ecological, and conservation questions in multiple spatio-temporal perspectives. As carnivores play key roles in trophic interactions, a better understanding of their distribution and habitat requirements are essential to establish conservation management plans and safeguard the future ecological health of Neotropical ecosystems. Our data paper, combined with other large-scale data sets, has great potential to clarify species distribution and related ecological processes within the Neotropics. There are no copyright restrictions and no restriction for using data from this data paper, as long as the data paper is cited as the source of the information used. We also request that users inform us of how they intend to use the data