Plastic pigtail vs lumen-apposing metal stents for drainage of walled-off necrosis (PROMETHEUS study): an open-label, multicenter randomized trial.

BACKGROUND: Lumen-apposing metal stents (LAMS) have displaced double-pigtail plastic stents (DPS) as the standard treatment for walled-off necrosis (WON),ß but evidence for exclusively using LAMS is limited. We aimed to assess whether the theoretical benefit of LAMS was superior to DPS. METHODS: This multicenter, open-label, randomized trial was carried out in 9 tertiary hospitals. Between June 2017, and Oct 2020, we screened 99 patients with symptomatic WON, of whom 64 were enrolled and randomly assigned to the DPS group (n = 31) or the LAMS group (n = 33). The primary outcome was short-term (4-weeks) clinical success determined by the reduction of collection. Secondary endpoints included long-term clinical success, hospitalization, procedure duration, recurrence, safety, and costs. Analyses were by intention-to-treat. CLINICALTRIALS: gov, NCT03100578. RESULTS: A similar clinical success rate in the short term (RR, 1.41; 95% CI 0.88-2.25; p = 0.218) and in the long term (RR, 1.2; 95% CI 0.92-1.58; p = 0.291) was observed between both groups. Procedure duration was significantly shorter in the LAMS group (35 vs. 45-min, p = 0.003). The hospital admission after the index procedure (median difference, - 10 [95% CI - 17.5, - 1]; p = 0.077) and global hospitalization (median difference - 4 [95% CI - 33, 25.51]; p = 0.82) were similar between both groups. Reported stent-related adverse events were similar for the two groups (36 vs.45% in LAMS vs. DPS), except for de novo fever, which was significantly 26% lower in LAMS (RR, 0.26 [0.08-0.83], p = 0.015). CONCLUSIONS: The clinical superiority of LAMS over DPS for WON therapy was not proved, with similar clinical success, hospital stay and similar safety profile between both groups, yet a significant reduction in procedure time was observed. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov, NCT03100578.

Study of the accuracy of a radial arterial pressure waveform cardiac output measurement device after cardiac surgery.

BACKGROUND: Less invasive monitoring, such as radial arterial pulse contour analysis (ProAQT® sensor), represents an alternative when hemodynamic monitoring is necessary to guide postoperative management and invasive monitoring is not technically feasible. The aim of the study is to evaluate the accuracy of the ProAQT® sensor cardiac output measurements in comparison with Pulmonary Artery Catheter (PAC) during the postoperative course of patients who underwent cardiac surgery with cardiopulmonary bypass. CASE PRESENTATION: Prospective observational study in a Surgical Intensive Care Unit of a tertiary university hospital. Ten patients with a mean age of 73.5 years were included. The main comorbidities were hypertension, diabetes, dyslipidemia and the preoperative left ejection fraction was 43.8 ± 14.5%. Regarding the type of surgery, six patients underwent valve surgery, two underwent coronary artery bypass grafting and two underwent aortic surgery. The cardiac index measured simultaneously by the ProAQT® sensor was compared with the PAC. The parameters were evaluated at predefined time points during the early postoperative courses (6 h, 12 h, 24 h, 48 h and 72 h). The degree of agreement with the cardiac index between the PAC and the ProAQT® sensor along the time points was measured using the concordance correlation coefficient, Bland-Altman analysis, and four-quadrant plot. Sixty-three pairs of measurements were analyzed. We showed that measurements of cardiac index were slightly higher with PAC (ß Ì‚ = - 0.146, p-value = 0.094). The concordance correlation coefficient for the additive model of cardiac index was 0.64 (95% Confidence Interval: 0.36, 0.82), indicating a high concordance between both sensors. Bland-Altmann analysis showed a mean bias of 0.45 L·min-1·m-2, limits of agreement from - 1.65 to 2.3 L·min-1·m-2, and percentage of error was 82.5%. Four-quadrant plot of changes in cardiac index showed a good concordance rate (75%), which increases after applying the exclusion zone (87%). CONCLUSIONS: In patients undergoing cardiac surgery, the ProAQT® sensor may be useful to monitor cardiac index during the postoperative period, especially when more invasive monitoring is not possible.

Regional Gene Expression of Inflammation and Oxidative Stress Responses Does Not Predict Neurodegeneration in Aging.

Brain aging is accompanied by increased oxidative stress and what has been termed "neuroinflammation," which might contribute to age-related neurodegenerative diseases. We analyzed expression in the transcription of innate inflammatory response genes in eleven representative regions including frontal, parietal, inferior temporal, cingulate, occipital, entorhinal cortex, caudate, putamen, thalamus, substantia nigra, and cerebellar vermis in aging human brains. We probed members of the complement system, colony stimulating factor receptors, toll-like receptors, and pro- and anti-inflammatory cytokines in the brains of subjects with no neurological disease and neurofibrillary tangles (mean age: 47.1 ± 5.7 years) and those with no neurological disease and neurofibrillary pathology stages I-II (mean age: 70.6 ± 6.3 years). Although the entorhinal and frontal cortex were most altered, gene regulation patterns did not match regions with increased vulnerability. Analysis of false discovery rate thresholds revealed no differences for any gene in any region between the 2 groups, including cases in which individual comparisons analyzed using Student t or nonparametric tests showed apparent differences between groups. Moreover, gene expression of major anti-oxidative stress responses did not match neuroinflammation in aging or increased regional susceptibility to major neurodegenerative diseases.

Validation of the FRAX predictive model for major osteoporotic fracture in a historical cohort of Spanish women.

FRAX is a fracture risk assessment tool to estimate the 10-yr probability of a major osteoporotic fracture or a hip fracture. The aim of the study was to assess the predictive ability of FRAX for major osteoporotic fracture in a cohort of Spanish women. The study was based on a retrospective cohort of women aged 40-90 yr. Patients were followed from their first bone densitometry to the first major osteoporotic fracture event (forearm, proximal humerus, clinical spine, or hip fracture) or for 10 yr whichever comes first. A total of 1231 women were included. Bone mineral density data and self-reported data on risk factors for fracture were obtained. The predictive ability of FRAX was assessed by analyzing calibration and discrimination, with the calculation of observed-to-expected (O/E) fracture ratios and the receiver operating characteristic (ROC) curve, respectively. A total of 222 women (18.1%) reported at least 1 fracture after the first assessment. The incidence of fracture was 14 (95% confidence interval [CI]: 10-17), 19 (95% CI: 15-23), 28 (95% CI: 21-36), and 67 (95% CI: 8-125) cases per 1000 woman-years in women aged <55, 55-64, 65-74, and ≥75 yr, respectively. The O/E ratio was 3.9 (95% CI: 3.4-4.5; p<0.0001). The area under the ROC curve was 61% (95% CI: 57-65%). FRAX underestimated the risk of major osteoporotic fracture in this cohort of Spanish women, particularly in those with a low risk of fracture according to the clinical factors used in the FRAX tool. Our findings highlight the need for validation studies of FRAX in Spain.

Desarrollo de un índice de capacidad estructural para hospitales de agudos con cirugía oncológica / Development of a structural capacity index for oncological surgery in acute hospitals

Introducción El estudio del impacto de la estructura sobre los resultados se ha basado principalmente en el número de intervenciones. El objetivo de este trabajo fue desarrollar un índice de capacidad estructural para hospitales de agudos con cirugía oncológica. Métodos Estudio transversal por encuesta, relativa a las características estructurales de los centros que habían realizado alguna intervención quirúrgica de oncología digestiva en Cataluña en 2004. Se desarrolló un índice sobre la base de la maximización de la fiabilidad, y se seleccionaron las variables por sus características métricas y también conceptuales. Resultados De los 45 centros seleccionados se obtuvo respuesta válida de 37. El conjunto de variables incluidas en el índice (relacionadas con la docencia, la gestión de casos y la tecnología) presentó buenas propiedades métricas (alfa de Cronbach: 0,92 y correlación ítem-total >0,7).Conclusiones El índice desarrollado permite clasificar los centros hospitalarios atendiendo a sus especificidades tecnológicas, organizativas y de gestión (AU)

Introduction The study of the impact of structure on outcomes has mainly been focused on the number procedures. The aim of our study was to develop a structure capacity index for hospitals for oncological surgery. Methods Cross-sectional study by means of a questionnaire related to the structural characteristics of hospitals that had performed gastrointestinal oncological surgery in Catalonia during 2004. Variables were considered for the index according to their measurement and conceptual properties. Results A response was obtained from 37 out of 48 hospitals. Variables with good conceptual and measurement properties (Cronbach alpha 0.92 and Item-Total correlation >0.7) were included in the index. These variables were related to teaching, management and technology. Conclusions The index has acceptable levels of reliability and validity, and can be a useful tool to classify hospitals according to their technological characteristics and management strategies (AU)

[Development of a structural capacity index for oncological surgery in acute hospitals]. / Desarrollo de un índice de capacidad estructural para hospitales de agudos con cirugía oncológica.

INTRODUCTION: The study of the impact of structure on outcomes has mainly been focused on the number procedures. The aim of our study was to develop a structure capacity index for hospitals for oncological surgery. METHODS: Cross-sectional study by means of a questionnaire related to the structural characteristics of hospitals that had performed gastrointestinal oncological surgery in Catalonia during 2004. Variables were considered for the index according to their measurement and conceptual properties. RESULTS: A response was obtained from 37 out of 48 hospitals. Variables with good conceptual and measurement properties (Cronbach alpha 0.92 and Item-Total correlation >0.7) were included in the index. These variables were related to teaching, management and technology. CONCLUSIONS: The index has acceptable levels of reliability and validity, and can be a useful tool to classify hospitals according to their technological characteristics and management strategies.