Effects of Achieving Rapid, Intensive, and Sustained Blood Pressure Reduction in Intracerebral Hemorrhage Expansion and Functional Outcome.

BACKGROUND AND OBJECTIVES: The time taken to achieve blood pressure (BP) control could be pivotal in the benefits of reducing BP in acute intracerebral hemorrhage (ICH). We aimed to assess the relationship between the rapid achievement and sustained maintenance of an intensive systolic BP (SBP) target with radiologic, clinical, and functional outcomes. METHODS: Rapid, Intensive, and Sustained BP lowering in Acute ICH (RAINS) was a multicenter, prospective, observational cohort study of adult patients with ICH <6 hours and SBP ≥150 mm Hg at 4 Comprehensive Stroke Centers during a 4.5-year period. Patients underwent baseline and 24-hour CT scans and 24-hour noninvasive BP monitoring. BP was managed under a rapid (target achievement ≤60 minutes), intensive (target SBP <140 mm Hg), and sustained (target stability for 24 hours) BP protocol. SBP target achievement ≤60 minutes and 24-hour SBP variability were recorded. Outcomes included hematoma expansion (>6 mL or >33%) at 24 hours (primary outcome), early neurologic deterioration (END, 24-hour increase in NIH Stroke Scale score ≥4), and 90-day ordinal modified Rankin scale (mRS) score. Analyses were adjusted by age, sex, anticoagulation, onset-to-imaging time, ICH volume, and intraventricular extension. RESULTS: We included 312 patients (mean age 70.2 ± 13.3 years, 202 [64.7%] male). Hematoma expansion occurred in 70/274 (25.6%) patients, END in 58/291 (19.9%), and the median 90-day mRS score was 4 (interquartile range, 2-5). SBP target achievement ≤60 minutes (178/312 [57.1%]) associated with a lower risk of hematoma expansion (adjusted odds ratio [aOR] 0.43, 95% confidence interval [CI] 0.23-0.77), lower END rate (aOR 0.43, 95% CI 0.23-0.80), and lower 90-day mRS scores (aOR 0.48, 95% CI 0.32-0.74). The mean 24-hour SBP variability was 21.0 ± 7.6 mm Hg. Higher 24-hour SBP variability was not related to expansion (aOR 0.99, 95% CI 0.95-1.04) but associated with higher END rate (aOR 1.15, 95% CI 1.09-1.21) and 90-day mRS scores (aOR 1.06, 95% CI 1.04-1.10). DISCUSSION: Among patients with acute ICH, achieving an intensive SBP target within 60 minutes was associated with lower hematoma expansion risk. Rapid SBP reduction and stable sustention within 24 hours were related to improved clinical and functional outcomes. These findings warrant the design of randomized clinical trials examining the impact of effectively achieving rapid, intensive, and sustained BP control on hematoma expansion. CLASSIFICATION OF EVIDENCE: This study provides Class III evidence that in adults with spontaneous ICH and initial SBP ≥150 mm Hg, lowering SBP to <140 mm Hg within the first hour and maintaining this for 24 hours is associated with decreased hematoma expansion.

Can the microcystic, elongated and fragmented pattern of invasion influence the evaluation of the depth of myometrial invasion in low-grade endometrioid endometrial cancer using imaging techniques?

Objectives: The microcystic, elongated and fragmented pattern of invasion can be associated with an underestimation of the depth of myometrial invasion by imaging techniques. We aimed to evaluate the influence of microcystic, elongated and fragmented pattern of invasion in the diagnostic performance of transvaginal ultrasound scan and magnetic resonance imaging for the prediction of the depth of myometrial invasion in low-grade endometrioid endometrial carcinomas. Methods: Prospective and consecutive study including all low-grade (G1-G2) endometrioid endometrial carcinomas diagnosed between October 2013 and July 2018 in a tertiary hospital. Preoperative staging was performed with transvaginal ultrasound scan and/or magnetic resonance imaging followed by surgical staging. Final histology was considered as the reference standard. Sensitivity, specificity and diagnostic accuracy for the prediction of depth of myometrial invasion was calculated for both imaging techniques. The STARD 2015 guidelines were used. Results: A total of 136 patients were consecutively included. Transvaginal ultrasound scan was performed in 132 patients and magnetic resonance imaging in 119 patients. The diagnostic accuracy of transvaginal ultrasound scan for the prediction of depth of myometrial invasion in the microcystic, elongated and fragmented negative group (82% (95% confidence interval = 73-88)) was higher compared to the microcystic, elongated and fragmented positive group (61% (95% confidence interval = 36-83)). The diagnostic accuracy of magnetic resonance imaging was also higher in the microcystic, elongated and fragmented negative group (80% (95% confidence interval = 71-87)) compared to the microcystic, elongated and fragmented positive (47% (95% confidence interval = 21-73)). Conclusions: In low-grade endometrioid endometrial carcinomas with a positive microcystic, elongated and fragmented pattern of invasion, the evaluation of the depth of myometrial invasion using transvaginal ultrasound scan and magnetic resonance imaging may be underestimated.

Nasal High-Flow for Weaning Preterm Newborns with Risk of Chronic Lung Disease from nCPAP.

OBJECTIVE: The aim of the study is to compare the duration of oxygen therapy by using two methods of weaning from nasal continuous positive airway pressure (nCPAP) in very preterm babies. STUDY DESIGN: Between April 2014 and December 2016, 90 preterm <32 weeks and birthweight >1,000 g who, after at least 7 days on nCPAP, were clinically stable on <6 cm H2O and FiO2 <30% were randomly assigned to weaning directly from nCPAP or with nasal high flow therapy (nHFT). In the nCPAP group, pressure was gradually reduced until the infant was stable on 4 cm H2O and then discontinued. In the nHFT group, flow rate was reduced until the infant was stable at 3.l pm and then discontinued. RESULTS: Eighty-four infants completed the study. There were no differences between the groups for the primary outcome, duration of oxygen therapy (median 33 [14-48] versus 28 [15-37] days; p = 0.17). The incidence of moderate-to-severe bronchopulmonary dysplasia was similar. Weaning time was shorter in the nCPAP group (p = 0.02), but the failure rate was slightly higher although non-significant. In the nHFT group, we observed better perception of patient comfort and a lower incidence of severe nasal injury. CONCLUSION: Weaning by nHFT compared with weaning directly off nCPAP does not prolong duration of oxygen therapy. Rather, it is associated with better perceptions of infant comfort among parents and lower rates of severe nasal injury. KEY POINTS: · Nasal high-flow therapy is commonly used in most neonatal intensive care unit for nCPAP weaning.. · Weaning by nHFT does not increase the duration of oxygen therapy.. · nHFT use improves the perception of infant comfort among parents..

Serum Levels of CXCL13 Are Associated With Teriflunomide Response in Patients With Multiple Sclerosis.

BACKGROUND AND OBJECTIVES: To identify biomarkers associated with treatment response in patients with multiple sclerosis (MS) treated with the oral therapies teriflunomide, dimethyl fumarate (DMF), and fingolimod. METHODS: Serum levels of IL-6, IL-17, TNF-α, granulocyte-macrophage colony-stimulating factor, IL-10, interferon-gamma (IFN-γ) IL-1ß, and chemokine ligand 13 (CXCL13) were measured at baseline and 12 months with single molecule array (Simoa) assays in a cohort of patients with MS treated with teriflunomide (N = 19), DMF (N = 22), and fingolimod (N = 25) and classified into "no evidence of disease activity" (NEDA) and EDA patients after 1 year of treatment. RESULTS: Serum CXCL13 and TNF-α levels were significantly decreased after treatment with teriflunomide in NEDA compared with EDA patients after 1 year of treatment (p = 0.008 for both cytokines). These findings were validated in an independent cohort of patients with MS treated with teriflunomide (N = 36) and serum CXCL13, and TNF-α levels were again significantly reduced in NEDA patients (p < 0.0001 for CXCL13 and p = 0.003 for TNF-α). CXCL13, but not TNF-α, showed good performance to classify NEDA and EDA patients according to a cut-off value of 9.64 pg/mL based on the change in CXCL13 levels between baseline and 12 months, with a sensitivity of 75% and specificity of 82% in the original cohort, and sensitivity of 65.4% and specificity of 60% in the validation cohort. DISCUSSION: Altogether, these results point to CXCL13 as a treatment response biomarker to teriflunomide in relapsing-remitting patients with MS, and the change in CXCL13 levels during the first year of treatment can be used in clinical practice to identify optimal responders to teriflunomide.

Adaptación y validacion al español de un cuestionario específico de calidad de vida en pacientes con traqueostomía (TQOL) / Adaptation and validation into Spanish of a specific questionnaire on quality of life in patients with tracheostomy (TQOL)

Antecedentes y objetivo: Una traqueostomía de larga duración puede tener efectos negativos significativos sobre la calidad de vida, ya que ocasiona cambios físicos, funcionales, sensoriales, psicológicos, sociales, económicos y laborales en la vida del individuo. El objetivo de este estudio fue validar al español un cuestionario de calidad de vida para estos pacientes.Materiales y métodosEstudio de validación psicométrica de un cuestionario en 45 pacientes mayores de 18 años, con permanencia de 6 meses de su traqueostomía, que entienden el español y comprenden bien las preguntas del cuestionario de salud SF-36 y de un cuestionario específico de calidad de vida del paciente con traqueostomía (TQOL-versión española). Este cuestionario es una modificación y adaptación cultural al español del instrumento original denominado Tracheostomy Specific Quality of Life Questionnaire (TQOL). Los 2 cuestionarios (TQOL-versión española) y SF-36 se cumplimentaron transcurridos los 6 meses desde la traqueostomía y entre 30 días y 50 días después de la primera administración. Se ha evaluado la fiabilidad y la repetitividad del TQOL-versión española. Se estudió la validez de constructo a través de la correlación entre los resultados del TQOL-versión española y las dimensiones del cuestionario SF-36.ResultadosLa fiabilidad del TQOL-versión española estimada mediante la prueba de alfa de Cronbach fue de 0,814, con variación entre ítems de 0,783 a 0,817 en la muestra a los 6 meses y de 0,794 en la muestra de validación, con variación entre ítems de 0,758 a 0,813. El coeficiente de correlación intraclase para la puntuación total de la escala mediante el análisis de concordancia de Bland-Altman y concordancia para las preguntas individuales con la prueba de simetría de McNemar fueron indicativos de buena estabilidad temporal. Se encontró una buena correlación entre las escalas del TQOL-versión española y las dimensiones del SF-36. (AU)

Background and objective: A long-term tracheostomy can have significant negative effects on quality of life because it causes physical, functional, sensory, psychological, social, economic, and work impairments to the life of the individual. The objective of this study was to validate in Spanish a quality-of-life questionnaire for these patients.Materials and methodsA psychometric validation study of a questionnaire in 45 patients over 18 years of age, with tracheostomy for six months, who understand Spanish and have a good understanding of the questions of the SF-36 questionnaire and a specific quality of life questionnaire for the patient with tracheostomy (TQOL-versión española). This questionnaire is a modification and cultural adaptation into Spanish of the original English instrument named Tracheostomy Specific Quality of Life Questionnaire (TQOL). The 2 questionnaires (TQOL-versión española) and the SF-36 were completed 6 months after the tracheostomy and between 30 and 50 days after the first administration. The reliability, repeatability, and construct validity of the TQOL-versión española were evaluated. The construct validity was assessed by the correlation between the results of the TQOL-versión española and the dimensions of the SF-36 questionnaire.ResultsThe reliability of the TQOL-versión española measured by Cronbach's alpha coefficient was .814, with variation between items from .783 to .817 in the sample at 6 months and from .794 in the validation sample, with variation between items from .758 to .813. There was intraclass correlation for the total score of the scale using the concordance analysis of Bland-Altman and agreement for the individual questions with the McNemar symmetry test. There was also a good correlation between the scales of the TQOL-versión española and the dimensions of the S-F36. (AU)

Adaptation and validation into Spanish of a specific questionnaire on quality of life in patients with tracheostomy (TQOL).

BACKGROUND AND OBJECTIVE: A long-term tracheostomy can have significant negative effects on quality of life because it causes physical, functional, sensory, psychological, social, economic, and work impairments to the life of the individual. The objective of this study was to validate in Spanish a quality-of-life questionnaire for these patients. MATERIALS AND METHODS: A psychometric validation study of a questionnaire in 45 patients over 18 years of age, with tracheostomy for six months, who understand Spanish and have a good understanding of the questions of the SF-36 questionnaire and a specific quality of life questionnaire for the patient with tracheostomy (TQOL-versión española). This Vquestionnaire is a modification and cultural adaptation into Spanish of the original English instrument named Tracheostomy Specific Quality of Life Questionnaire (TQOL). The two questionnaires (TQOL-versión española) and the SF-36 were completed 6 months after the tracheostomy and between 30 and 50 days after the first administration. The reliability, repeatability, and construct validity of the TQOL-versión española were evaluated. The construct validity was assessed by the correlation between the results of the TQOL-versión española and the dimensions of the SF-36 questionnaire. RESULTS: The reliability of the TQOL-versión española measured by Cronbach's alpha coefficient was .814, with variation between items from .783 to .817 in the sample at 6 months and from .794 in the validation sample, with variation between items from .758 to .813. There was intraclass correlation for the total score of the scale using the concordance analysis of Bland-Altman and agreement for the individual questions with the McNemar symmetry test. There was also a good correlation between the scales of the TQOL-versión española and the dimensions of the S-F36. CONCLUSIONS: The TQOL-versión española showed good reliability, repeatability, and construct validity, therefore it is a useful tool to assess the impact on individual patients with a tracheostomy in place for more than 6 months, and to establish strategies at the healthcare and social levels to improve the quality of daily life.

Early outcomes in adults hospitalized with severe SARS-CoV-2 infection receiving tocilizumab.

Background: Modulation of the immune system to prevent lung injury is being widely used against the new coronavirus disease (COVID-19). The primary endpoint was mortality at 7 days after tocilizumab administration. Secondary endpoints were admission to the intensive care unit, development of ARDS and respiratory insufficiency among others. Methods: We report the preliminary results from the Vall d'Hebron cohort study at Vall d'Hebron University Hospital, in Barcelona (Spain), including all consecutive patients who had a confirmed SARS-CoV-2 infection and who were treated with tocilizumab until March 25th. Results: 82 patients with COVID-19 received at least one dose of tocilizumab. The mean (± SD) age was 59.1 (19.8) years, 63% were male, 22% were of non-Spanish ancestry, and the median (IQR) age-adjusted Charlson index at baseline was 3 (1-4) points. Respiratory failure and ARDS developed in 62 (75.6%) and 45 (54.9%) patients, respectively. Median time from symptom onset to ARDS development was 8 (5-11) days. Mortality at 7 days was 26.8%. Hazard ratio for mortality was 3.3; 95% CI, 1.3-8.5 (age-adjusted hazard ratio for mortality 2.1; 95% CI, 0.8-5.8) if tocilizumab was administered after the onset of ARDS. Conclusion: Early administration of tocilizumab in patients needing oxygen supplementation may be critical to patient recovery. Our preliminary data could inform bedside decisions until more data regarding the precise timing in of initiation of the treatment with tocilizumab.

Antecedentes: Los tratamientos inmunomoduladores para la prevención del daño pulmonar están siendo ampliamente estudiados contra la COVID-19. El objetivo primario es evaluar la mortalidad a los 7 días después de la administración de tocilizumab. El objetivo secundario es el ingreso en UCI, el desarrollo de distrés respiratorio agudo e insuficiencia respiratoria aguda entre otros. Métodos: Informamos sobre los resultados preliminares de la cohorte del Hospital Universitario Vall d'Hebron en Barcelona (España), que incluye todos los pacientes consecutivos con infección confirmada por SARS-CoV-2 y que recibieron tratamiento con tocilizumab hasta el 25 de marzo 2020. Resultados: Ochenta y dos pacientes con COVID-19 recibieron al menos una dosis de tocilizumab. La edad media (±DE) fue de 59,1 (±19,8) años, el 63% eran hombres, 22% correspondía a paciente nacidos fuera de España, y la mediana (RIC) del índice de Charlson ajustado por edad en el momento basal fue de 3 (1-4) puntos. Sesenta y dos pacientes (75,6%) y 45 pacientes (54,9%) desarrollaron insuficiencia respiratoria y distrés respiratorio agudo respectivamente. La mediana de tiempo desde el inicio de los síntomas hasta el desarrollo de ditrés fue de 8 días (5-11). La mortalidad a los 7 días fue del 26,8% La hazard ratio de mortalidad fue del 3,3; IC 95% 1,3-8,5 (la hazard ratio de mortalidad ajustada por edad fue de 2,1; IC 95% 0,8-5,8) si el tocilizumab se administraba después del inicio del distrés respiratorio. Conclusión: La administración precoz de tocilizumab en pacientes con suplementos de oxígeno podría ser crítica para la recuperación de los pacientes. Nuestros datos podrían ayudar a tomar decisiones clínicas hasta que se disponga de más información sobre el momento adecuado para iniciar el tratamiento con tocilizumab.

Corrigendum: Dynamics of Emergency Cardiovascular Hospital Admissions and In-Hospital Mortality During the COVID-19 Pandemic: Time Series Analysis and Impact of Socioeconomic Factors.

[This corrects the article DOI: 10.3389/fcvm.2022.827212.].

Early outcomes in adults hospitalized with severe SARS-CoV-2 infection receiving tocilizumab / Resultados preliminares en pacientes adultos con infección grave por SARS-CoV-2 tratados con tocilizumab

Background:Modulation of the immune system to prevent lung injury is being widely used against the new coronavirus disease (COVID-19). The primary endpoint was mortality at 7 days after tocilizumab administration. Secondary endpoints were admission to the intensive care unit, development of ARDS and respiratory insufficiency among others.Methods:We report the preliminary results from the Vall d’Hebron cohort study at Vall d’Hebron University Hospital, in Barcelona (Spain), including all consecutive patients who had a confirmed SARS-CoV-2 infection and who were treated with tocilizumab until March 25th.Results:82 patients with COVID-19 received at least one dose of tocilizumab. The mean (± SD) age was 59.1 (19.8) years, 63% were male, 22% were of non-Spanish ancestry, and the median (IQR) age-adjusted Charlson index at baseline was 3 (1–4) points. Respiratory failure and ARDS developed in 62 (75.6%) and 45 (54.9%) patients, respectively. Median time from symptom onset to ARDS development was 8 (5–11) days. Mortality at 7 days was 26.8%. Hazard ratio for mortality was 3.3; 95% CI, 1.3–8.5 (age-adjusted hazard ratio for mortality 2.1; 95% CI, 0.8–5.8) if tocilizumab was administered after the onset of ARDS.Conclusion:Early administration of tocilizumab in patients needing oxygen supplementation may be critical to patient recovery. Our preliminary data could inform bedside decisions until more data regarding the precise timing in of initiation of the treatment with tocilizumab. (AU)

Antecedentes:Los tratamientos inmunomoduladores para la prevención del daño pulmonar están siendo ampliamente estudiados contra la COVID-19. El objetivo primario es evaluar la mortalidad a los 7 días después de la administración de tocilizumab. El objetivo secundario es el ingreso en UCI, el desarrollo de distrés respiratorio agudo e insuficiencia respiratoria aguda entre otros.Métodos:Informamos sobre los resultados preliminares de la cohorte del Hospital Universitario Vall d’Hebron en Barcelona (España), que incluye todos los pacientes consecutivos con infección confirmada por SARS-CoV-2 y que recibieron tratamiento con tocilizumab hasta el 25 de marzo 2020.Resultados:Ochenta y dos pacientes con COVID-19 recibieron al menos una dosis de tocilizumab. La edad media (±DE) fue de 59,1 (±19,8) años, el 63% eran hombres, 22% correspondía a paciente nacidos fuera de España, y la mediana (RIC) del índice de Charlson ajustado por edad en el momento basal fue de 3 (1-4) puntos. Sesenta y dos pacientes (75,6%) y 45 pacientes (54,9%) desarrollaron insuficiencia respiratoria y distrés respiratorio agudo respectivamente. La mediana de tiempo desde el inicio de los síntomas hasta el desarrollo de ditrés fue de 8 días (5-11). La mortalidad a los 7 días fue del 26,8% La hazard ratio de mortalidad fue del 3,3; IC 95% 1,3-8,5 (la hazard ratio de mortalidad ajustada por edad fue de 2,1; IC 95% 0,8-5,8) si el tocilizumab se administraba después del inicio del distrés respiratorio.Conclusión:La administración precoz de tocilizumab en pacientes con suplementos de oxígeno podría ser crítica para la recuperación de los pacientes. Nuestros datos podrían ayudar a tomar decisiones clínicas hasta que se disponga de más información sobre el momento adecuado para iniciar el tratamiento con tocilizumab. (AU)

Dynamics of Emergency Cardiovascular Hospital Admissions and In-Hospital Mortality During the COVID-19 Pandemic: Time Series Analysis and Impact of Socioeconomic Factors.

Aims: This study aimed to evaluate the decline in urgent cardiovascular hospital admissions and in-hospital mortality during the COVID pandemic in two successive waves, and to evaluate differences by sex, age, and deprivation index subgroups. Methods and Results: We obtained acute cardiovascular hospital episodes during the years 2019-2020 from region-wide data on public healthcare usage for the population of Catalonia (North-East Spain). We fitted time models to estimate the incidence rate ratios (IRRs) of the acute coronary syndrome (ACS) and acute heart failure (HF) admissions during the first pandemic wave, the between-waves period, and the second wave compared with the corresponding pre-COVID-19 periods and to test for the interaction with sex, age, and area-based socioeconomic level. We evaluated the effect of COVID-19 period on in-hospital mortality. ACS (n = 8,636) and HF (n = 27,566) episodes were defined using primary diagnostic ICD-10 codes. ACS and HF admissions decreased during the first wave (IRR = 0.66, 95%CI: 0.58-0.76 and IRR = 0.61, 95% CI: 0.55-0.68, respectively) and during the second wave (IRR = 0.80, 95%CI: 0.72-0.88 and IRR = 0.76, 95%CI: 0.69-0.84, respectively); acute HF admissions also decreased in the period between waves (IRR: 0.81, 95%CI: 0.74-0.89). The impact was similar in all sex and socioeconomic subgroups and was higher in older patients with ACS. In-hospital mortality was higher than expected only during the first wave. Conclusion: During the first wave of the COVID-19 pandemic, there was a marked decline in urgent cardiovascular hospital admissions that were attenuated during the second wave. Both the decline and the attenuation of the effect have been similar in all subgroups regardless of age, sex, or socioeconomic status. In-hospital mortality for ACS and HF episodes increased during the first wave, but not during the second wave.

Adjuvant therapy in early-stage cervical cancer after radical hysterectomy: are we overtreating our patients? A meta-analysis.

OBJECTIVE: There is a gap in knowledge regarding the ideal management of patients with early-stage cervical cancer and intermediate-risk features. Here, we present a meta-analysis of the published literature on oncological outcomes in these patients and determine trends in postoperative management. METHODS: MEDLINE and PubMed were used for literature searches. The inclusion criteria were: English language articles including ≥ 10 patients, patients who underwent radical hysterectomy, nodes negative, studies reporting oncological outcomes and complications treatment-related and compare a surgery-only cohort with a radiotherapy cohort. The PRISMA guidelines were followed. Combined relative risk was calculated using DerSimonian-Laird random-effects model and a forest plot was drawn. RESULTS: We collected 183 manuscripts on early-stage cervical cancer treated with radical hysterectomy alone or with adjuvant radiotherapy after surgery. A total of eight studies met the inclusion criteria. Regarding oncological outcomes, survival was reported in five studies. The relative risk of recurrence and the relative risk of mortality was similar in both groups independently whether receive or not adjuvant therapy. Most of the studies did not report significant differences regarding morbidity treatment related between the groups, except for a higher rate of lymphedema after radiotherapy. CONCLUSION: We found that the relative risk of recurrence and mortality was similar in both groups not depending on adjuvant therapy. Therefore, whether radiotherapy adjuvant treatment is indicated remains a topic of debate.

Surgeon preimplantation macroscopic graft appraisal improves risk stratification of deceased kidney donors: a prospective study.

BACKGROUND: Preimplantation scores assist with correct kidney graft allocation, but macroscopic graft features have never been evaluated in this scenario. METHODS: We designed a graft appraisal questionnaire, assessed its reproducibility by comparing the senior and junior surgeon responses and evaluated which features can predict transplant outcomes in 202 patients transplanted from 144 donors at a tertiary center. We created new prediction models in combination with validated preimplantation scores. The primary outcome was graft loss or eGFR<30 mL/min/1.73 m2 at six months and secondary outcomes were delayed graft function, early graft loss and graft function at six months. RESULTS: Interrater correlation was very good for adherent perinephric fat (kappa=0.91) and acceptable for cortical surface roughness (kappa=0.51) and cortical color (kappa=0.47). Adherent perirenal fat (Odds ratio=4.77; 95% CI: 2.10-10.85) and surface roughness (OR=2.11, 95% CI: 1.25-3.58) were independent predictors of the primary outcome, improving the kidney donor risk index efficacy model (AUC 0.71 vs. 0.82, P≤0.001), while cortical color and adherent fat improved the Irish risk model for delayed graft function (AUC 0.76 vs. 0.82, P=0.03). We created nomograms to visually assess the risk of both endpoints. CONCLUSIONS: Kidney graft macroscopic appraisal is reproducible between surgeons and can improve the accuracy of clinical preimplantational prediction scores.

Early Tracheostomy for Managing ICU Capacity During the COVID-19 Outbreak: A Propensity-Matched Cohort Study.

BACKGROUND: During the first wave of the COVID-19 pandemic, shortages of ventilators and ICU beds overwhelmed health care systems. Whether early tracheostomy reduces the duration of mechanical ventilation and ICU stay is controversial. RESEARCH QUESTION: Can failure-free day outcomes focused on ICU resources help to decide the optimal timing of tracheostomy in overburdened health care systems during viral epidemics? STUDY DESIGN AND METHODS: This retrospective cohort study included consecutive patients with COVID-19 pneumonia who had undergone tracheostomy in 15 Spanish ICUs during the surge, when ICU occupancy modified clinician criteria to perform tracheostomy in Patients with COVID-19. We compared ventilator-free days at 28 and 60 days and ICU- and hospital bed-free days at 28 and 60 days in propensity score-matched cohorts who underwent tracheostomy at different timings (≤ 7 days, 8-10 days, and 11-14 days after intubation). RESULTS: Of 1,939 patients admitted with COVID-19 pneumonia, 682 (35.2%) underwent tracheostomy, 382 (56%) within 14 days. Earlier tracheostomy was associated with more ventilator-free days at 28 days (≤ 7 days vs > 7 days [116 patients included in the analysis]: median, 9 days [interquartile range (IQR), 0-15 days] vs 3 days [IQR, 0-7 days]; difference between groups, 4.5 days; 95% CI, 2.3-6.7 days; 8-10 days vs > 10 days [222 patients analyzed]: 6 days [IQR, 0-10 days] vs 0 days [IQR, 0-6 days]; difference, 3.1 days; 95% CI, 1.7-4.5 days; 11-14 days vs > 14 days [318 patients analyzed]: 4 days [IQR, 0-9 days] vs 0 days [IQR, 0-2 days]; difference, 3 days; 95% CI, 2.1-3.9 days). Except hospital bed-free days at 28 days, all other end points were better with early tracheostomy. INTERPRETATION: Optimal timing of tracheostomy may improve patient outcomes and may alleviate ICU capacity strain during the COVID-19 pandemic without increasing mortality. Tracheostomy within the first work on a ventilator in particular may improve ICU availability.

Menopause does not modify disability trajectories in a longitudinal cohort of women with clinically isolated syndrome and multiple sclerosis followed from disease onset.

BACKGROUND AND PURPOSE: To evaluate the effect of menopause on disability accumulation in women followed from their clinically isolated syndrome (CIS). METHODS: We examined the longitudinal changes in Expanded Disability Status Scale (EDSS) scores from CIS until the last follow-up in women belonging to the Barcelona CIS prospective cohort, followed through their menopausal transition. The analysis is based on 13,718 EDSS measurements, with an average of 28 EDSS measurements per patient. Differences in EDSS trajectories between menopausal and nonmenopausal women, controlling for age and disease duration, were evaluated. We performed two sensitivity analyses in women with confirmed MS and in those experiencing early menopause. RESULTS: From 764 eligible women, 496 (65%) responded to the questionnaire, and 74 (14.9%) reached menopause over the follow-up. We did not find a significant inflection point in EDSS trajectories around menopause (slope change -0.009; 95% CI -0.066; 0.046). The annual increase in EDSS over the complete course of the disease was significantly higher in menopausal women (0.049; 95% CI, 0.026-0.074) versus nonmenopausal (0.019; 95% CI, 0.008-0.031; interaction p value 0.025). This difference was lost when controlling for age and disease duration (EDSS annual increase of 0.059; 95% CI, 0.025-0.094 vs. 0.038; 95% CI, 0.021-0.057, respectively; interaction p value 0.321). No inflection point was detected when the analysis was restricted to women with confirmed MS or with earlier menopause. CONCLUSIONS: Menopause is not associated with an increased risk of disability in a CIS population, considering EDSS trajectories throughout the course of the disease together with age and disease duration.

Early outcomes in adults hospitalized with severe SARS-CoV-2 infection receiving tocilizumab.

BACKGROUND: Modulation of the immune system to prevent lung injury is being widely used against the new coronavirus disease (COVID-19). The primary endpoint was mortality at 7 days after tocilizumab administration. Secondary endpoints were admission to the intensive care unit, development of ARDS and respiratory insufficiency among others. METHODS: We report the preliminary results from the Vall d'Hebron cohort study at Vall d'Hebron University Hospital, in Barcelona (Spain), including all consecutive patients who had a confirmed SARS-CoV-2 infection and who were treated with tocilizumab until March 25th. RESULTS: 82 patients with COVID-19 received at least one dose of tocilizumab. The mean (± SD) age was 59.1 (19.8) years, 63% were male, 22% were of non-Spanish ancestry, and the median (IQR) age-adjusted Charlson index at baseline was 3 (1-4) points. Respiratory failure and ARDS developed in 62 (75.6%) and 45 (54.9%) patients, respectively. Median time from symptom onset to ARDS development was 8 (5-11) days. Mortality at 7 days was 26.8%. Hazard ratio for mortality was 3.3; 95% CI, 1.3-8.5 (age-adjusted hazard ratio for mortality 2.1; 95% CI, 0.8-5.8) if tocilizumab was administered after the onset of ARDS. CONCLUSION: Early administration of tocilizumab in patients needing oxygen supplementation may be critical to patient recovery. Our preliminary data could inform bedside decisions until more data regarding the precise timing in of initiation of the treatment with tocilizumab.

Pulmonary Arterial Remodeling Is Related to the Risk Stratification and Right Ventricular-Pulmonary Arterial Coupling in Patients With Pulmonary Arterial Hypertension.

BACKGROUND: Pulmonary arterial (PA) stiffness has an essential contribution to the right ventricular (RV) failure pathogenesis. A comprehensive and multiparameter risk assessment allows predicting mortality and guiding treatment decisions in PA hypertension (PAH). We characterize PA remodeling with intravascular ultrasound (IVUS) in prevalent and stable patients with PAH according to the ESC/ERS risk table and analyze the RV-PA coupling consequences. METHODS: Ten control subjects and 20 prevalent PAH adult patients underwent right heart catheterization (RHC) with simultaneous IVUS study. We estimated cardiac index (CI), pulmonary vascular resistance, and compliance (PVR, PAC) by standard formulas. From IVUS and RHC data, PA diameter, wall thickness/luminal diameter ratio, and indexes of stiffness (pulsatility, compliance, distensibility, incremental elastic modulus - Einc-, and the stiffness index ß) were measured. We evaluated RV-PA coupling by the ratio of tricuspid annular plane systolic excursion to systolic pulmonary arterial pressure (TAPSE/sPAP). The individual average risk was calculated by assigning a score of 1 (low-risk -LR-), 2 (intermediate-risk -IR-), and 3 (high-risk -HR-) for each of seven variables (functional class, six-minute walking test, brain natriuretic peptide, right atrial area and pressure, CI, and PA oxygen saturation) and rounding the average value to the nearest integer. RESULTS: All PA segments interrogated showed increased vessel diameter, wall cross-sectional area (WCSA), and stiffness in patients with PAH compared to control subjects. 45% corresponded to LR, and 55% corresponded to IR PAH patients. The different measurements of PA stiffness showed significant correlations with TAPSE/sPAP (r = 0.6 to 0.76) in PAH patients. The IR group had higher PA stiffness and lower relative WCSA than LR patients (P < 0.05), and it is associated with a lower PAC and TAPSE/sPAP (P < 0.05). CONCLUSION: In prevalent PAH patients, the severity of proximal PA remodeling is related to the risk stratification and associated with PAC and RV-PA coupling impairment beyond the indirect effect of the mean PA pressure. The concomitant assessment of IVUS and hemodynamic parameters at diagnosis and follow-up of PAH patients could be a feasible and safe tool for risk stratification and treatment response of the PA vasculopathy during serial hemodynamic measurements.

30-Day Mortality Following Palliative Radiotherapy.

PURPOSE: 30-day mortality (30-DM) is a parameter with widespread use as an indicator of avoidance of harm used in medicine. Our objective is to determine the 30-DM followed by palliative radiation therapy (RT) in our department and to identify potential prognosis factors. MATERIAL/METHODS: We conducted a retrospective cohort study including patients treated with palliative RT in our center during 2018 and 2019. Data related to clinical and treatment characteristics were collected. RESULTS: We treated 708 patients to whom 992 palliative irradiations were delivered. The most frequent primary tumor sites were lung (31%), breast (14.8%), and gastrointestinal (14.8%). Bone was the predominant location of the treatment (56%), and the use of single doses was the preferred treatment schedule (34.4%). The 30-DM was 17.5%. For those who died in the first month the median survival was 17 days. Factors with a significant impact on 30-DM were: male gender (p < 0.0001); Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 2-3 (p = 0.0001); visceral metastases (p = 0.0353); lung, gastrointestinal or urinary tract primary tumors (p = 0.016); and single dose RT (p = <0.0001). In the multivariate analysis, male gender, ECOG PS 2-3, gastrointestinal and lung cancer were found to be independent factors related to 30-DM. CONCLUSION: Our 30-DM is similar to previous studies. We have found four clinical factors related to 30-DM of which ECOG was the most strongly associated. This data may help to identify terminally ill patients with poor prognosis in order to avoid unnecessary treatments.