Trends and Outcomes in Lung Transplantation in Patients with and without Idiopathic Pulmonary Fibrosis in Spain during the Period 2016-2020.

(1) Background: This paper aims to assess temporal trends (2016-2020) in incidence, patient's characteristics, complications, length of hospital stay (LOHS) and in-hospital mortality (IHM) among patients with and without idiopathic pulmonary fibrosis (IPF) undergoing lung transplantation (LTx). We also analyse the effect of the COVID-19 pandemic on LTx in these populations. (2) Methods: A retrospective, population-based observational study was conducted using the Spanish National Hospital Discharge Database. Multivariable adjustment was conducted with logistic regression to analyse the IHM. (3) Results: We identified 1777 admissions for LTx during the study period, of which 573 (32.2%) were performed in patients with IPF. The number of hospital admissions for LTx rose from 2016 to 2020, both in patients with and without IPF, but a marked reduction was observed from year 2019 to year 2020. Over time, the proportion of single LTx decreased and bilateral LTx increased significantly in both groups. The incidence of LTx complications increased significantly over time along with the increase in the incidence of IPF. No significant differences in the incidence of complications or in the IHM between patients with and without IPF were found. Suffering any complication of the LTx and pulmonary hypertension were conditions positively associated with IHM in patients with and without IPF. The IHM remained stable from 2016 to 2020 in both study populations and was not affected by the COVID pandemic. (4) Conclusions: Patients with IPF account for almost a third of all lung transplants. The number of LTx increased over time in patients with and without IPF, but a marked reduction was observed from 2019 to 2020. Although the proportion of LTx complications increased significantly over time in both groups, the IHM did not change. IPF was not associated with increased complications or IHM after LTx.

Trends in hospital admissions among children with asthma in Spain (2011-2020).

The purpose of this study is to describe and assess changes in incidence, clinical conditions, use of mechanical ventilation, length of hospital stay (LOHS), and in-hospital mortality (IHM) among children hospitalized with asthma in Spain from 2011 to 2020. We analyzed children aged 0 to 15 years hospitalized with an ICD code for asthma included in the Spanish National Hospital Discharge Database (SNHDD). The analysis was conducted for asthma as the primary diagnosis and with asthma in any diagnosis position. Joinpoint regression was used to assess time trends in incidence. We included a total of 85,664 children hospitalized with asthma; of these, 46,727 (54.55%) had asthma coded as the primary diagnosis. The number of boys was higher than the number of girls, irrespective of age group or diagnostic position. The frequency of asthma as primary diagnosis decreased from 55.7% in 2011 to 43.96% in 2020 (p < 0.001). The incidence of hospitalizations because of asthma decreased significantly from 2011 to 2020, with a faster decrease from 2018 onwards. Over time, the proportion of older children increased. In the year 2020, only 55 children had codes for asthma and COVID-19 in their discharge report, and this infection had no effect on hospitalizations this year. A significant increase in the use of non-invasive ventilation (NIV) was observed over time. Irrespective of the diagnostic position, LOHS and IHM remained stable over time, with the IHM under 0.1%.  Conclusion: Our results show a decrease in the incidence of hospital admissions with asthma either as the primary diagnosis or in any position. The age of children hospitalized seems to be increasing as the use of NIV. Better management of the disease from primary care and the emergency department as is the use of NIV could explain the reduction in incidence. What is Known: • Asthma is the most common chronic respiratory in childhood in high income countries. • The incidence of hospital admissions with asthma and associated factors is one of the best sources of information on morbidity trends and prognosis. What is New: • The incidence of hospital admissions for asthma in Spain decreased in children between 2011 and 2020 with a more frequent use of non-invasive mechanical ventilation and low mortality rates. • COVID-19 did not cause an increase in admissions with asthma in the year 2020.

Trends in prevalence and the effects on hospital outcomes of dementia in patients hospitalized with acute COPD exacerbation.

AIMS: To assess changes in prevalence and the effects on hospital outcomes of dementia among patients hospitalized with an acute exacerbation of chronic obstructive pulmonary disease (AE-COPD); and to evaluate sex-differences, as well as the impact of COVID-19 pandemic in this relationship. METHODS: We used a nationwide discharge database to select patients admitted with AE-COPD in Spain from 2011 to 2020. We identified those with any type of dementia, vascular dementia (VaD) or Alzheimer's disease (AD). RESULTS: We identified 658,429 hospitalizations with AE-COPD (4.45% had any type of dementia, 0.79% VaD and 1.57% AD). The presence of any type of dementia remained stable from 2011 to 2015, and increased significantly between 2016 and 2020. For VaD, the time trend showed no change until 2020, when a significant increment was found. The probability of AD decreased significantly overtime. The in-hospital mortality (IHM) among patients with any type of dementia remained stable overtime until 2020, when it increased significantly. Older age, higher comorbidity, COVID-19, and use of mechanical ventilation were variables associated to IHM. Women had lower risk of dying in the hospital than men in all subgroups. CONCLUSIONS: After a previous period of stability, the prevalence of any type of dementia increased over the last 5 years of the study, although we identified different trends depending on the specific cause of dementia. The IHM remained stable overtime until 2020, when it increased, probably related to the COVID-19 pandemic. It is remarkable the protective effect of female sex for IHM.

Differences in Sex and the Incidence and In-Hospital Mortality among People Admitted for Infective Endocarditis in Spain, 2016-2020.

(1) Background: A description of the trends and outcomes during hospitalization for infective endocarditis (IE) according to sex. (2) Methods: Using Spanish national hospital discharge data (2016-2020), we built Poisson regression models to compare the age-adjusted time trends for the incidence rate. We used propensity score matching (PSM) to compare the clinical characteristics and the in-hospital mortality (IHM) between men and women hospitalized with IE. (3) Results: We identified 10,459 hospitalizations for IE (33.26% women). The incidence of IE remained stable during this five-year period. The age-adjusted incidence of IE was two-fold higher among men vs. women (IRR = 2.08; 95%CI 2.0-2.17). Before PSM, women with IE were significantly older than men (70.25 vs. 66.24 years; p < 0.001) and had lower comorbidity according to the Charlson comorbidity index (mean 1.38 vs. 1.43; p = 0.019). After PSM, the IHM among women admitted for IE remained >3 points higher than that among men (19.52% vs. 15.98%; p < 0.001). (4) Conclusions: The incidence of IE was two-fold higher among men than among women. IHM was significantly higher among women after accounting for the potential confounders.

Prevalence of Dementia among Patients Hospitalized with Type 2 Diabetes Mellitus in Spain, 2011-2020: Sex-Related Disparities and Impact of the COVID-19 Pandemic.

(1) Background: To assess changes in the prevalence of dementia among patients hospitalized with type 2 diabetes (T2DM), to analyze the effects of dementia on in-hospital mortality (IHM) in this population, to evaluate sex differences, and to determine the impact of the COVID-19 pandemic on these parameters. (2) Methods: We used a nationwide discharge database to select all patients with T2DM aged 60 years or over admitted to Spanish hospitals from 2011 to 2020. We identified those with all-cause dementia, Alzheimer's disease (AD), and vascular dementia (VaD). The effect of sex, age, comorbidity, and COVID-19 on the prevalence of dementia subtypes and on IHM was assessed using multivariable logistic regression. (3) Results: We identified 5,250,810 hospitalizations with T2DM. All-cause dementia was detected in 8.31%, AD in 3.00%, and VaD in 1.55%. The prevalence of all subtypes of dementia increased significantly over time. After multivariable adjustment, higher values were observed in women for all-cause dementia (OR 1.34; 95% CI 1.33-1.35), AD (OR 1.6; 95% CI 1.58-1.62), and VaD (OR 1.12; 95% CI 1.11-1.14). However, female sex was a protective factor for IHM in patients with all-cause dementia (OR 0.90; 95% CI 0.89-0.91), AD (OR 0.89; 95% CI 0.86-0.91), and VaD (OR 0.95; 95% CI 0.91-0.99). IHM among patients with dementia remained stable over time, until 2020, when it increased significantly. Higher age, greater comorbidity, and COVID-19 were associated with IHM in all dementia subtypes. (4) Conclusions: The prevalence of dementia (all-cause, AD, and VaD) in men and women with T2DM increased over time; however, the IHM remained stable until 2020, when it increased significantly, probably because of the COVID-19 pandemic. The prevalence of dementia is higher in women than in men, although female sex is a protective factor for IHM.

A Randomised trial of anti-GM-CSF Otilimab in severe COVID-19 pneumonia (OSCAR).

Abstract BACKGROUND: Granulocyte-macrophage colony-stimulating factor (GM-CSF) and dysregulated myeloid cell responses are implicated in the pathophysiology and severity of coronavirus disease 2019 (COVID-19). METHODS: In this randomised, sequential, multicentre, placebo-controlled, double-blind study, adults aged 18-79 years (Part 1) or ≥70 years (Part 2) with severe COVID-19, respiratory failure, and systemic inflammation (elevated C-reactive protein/ferritin) received a single intravenous infusion of otilimab 90 mg (human anti-GM-CSF monoclonal antibody) plus standard care (NCT04376684). The primary outcome was the proportion of patients alive and free of respiratory failure at Day 28. RESULTS: In Part 1 (N=806 randomised 1:1 otilimab:placebo), 71% of otilimab-treated patients were alive and free of respiratory failure at Day 28 versus 67% who received placebo; the model-adjusted difference of 5.3% was not statistically significant (95% CI -0.8, 11.4; p=0.09). A nominally significant model-adjusted difference of 19.1% (95% CI 5.2, 33.1; p=0.009) was observed in the predefined 70-79 years subgroup, but this was not confirmed in Part 2 (N=350 randomised) where the model-adjusted difference was 0.9% (95% CI -9.3, 11.2; p=0.86). Compared with placebo, otilimab resulted in lower serum concentrations of key inflammatory markers, including the putative pharmacodynamic biomarker CCL17, indicative of GM-CSF pathway blockade. Adverse events were comparable between groups and consistent with severe COVID-19. CONCLUSIONS: There was no significant difference in the proportion of patients alive and free of respiratory failure at Day 28. However, despite the lack of clinical benefit, a reduction in inflammatory markers was observed with otilimab, in addition to an acceptable safety profile.

Time Trends in Clinical Characteristics and Hospital Outcomes of Hospitalizations for Lung Transplantation in COPD Patients in Spain from 2016 to 2020-Impact of the COVID-19 Pandemic.

(1) Background: To examine the clinical characteristics and hospital outcomes of hospitalization for lung transplantation in COPD patients in Spain from 2016 to 2020; and to assess if the COVID-19 pandemic has affected the number or the outcomes of lung transplantations in these patients. (2) Methods: We used the Spanish National Hospital Discharge Database to select subjects who had a code for COPD (ICD-10: J44) and had undergone a lung transplantation (ICD-10 codes OBYxxxx). (3) Results: During the study period, 704 lung transplants were performed among COPD patients (single 31.68%, bilateral 68.32%). The absolute number of transplants increased with raising rates of 8%, 14% and 19% annually from 2016 to 2019. However, a marked decrease of -18% was observed from 2019 to year 2020. Overall, 47.44% of the patients suffered at least one complication, being the most frequent lung transplant rejection (24.15%), followed by lung transplant infection (13.35%). The median length of hospital stay (LOHS) was 33 days and the in-hospital-mortality (IHM) was 9.94%. Variables associated with increased risk of mortality were a Comorbidity Charlson Index ≥ 1 (OR 1.82; 95%CI 1.08-3.05) and suffering any complication of the lung transplantation (OR 2.14; 95%CI 1.27-3.6). COPD patients in 2020 had a CCI ≥ 1 in a lower proportion than 2019 patients (29.37 vs. 38.51%; p = 0.015) and less frequently suffered any complications after the lung transplantation (41.26 vs. 54.6%; p = 0.013), no changes in the LOHS or the IHM were detected from 2019 to 2020. (4) Conclusions: Our study showed a constant increase in the number of lung transplantations from 2016 to 2019 in COPD patients, with a drop from 2019 to 2020, probably related to the COVID-19 pandemic. However, no changes in LOHS or IHM were detected over time.

Use of Cardiac Procedures in People with Diabetes during the COVID Pandemic in Spain: Effects on the In-Hospital Mortality.

We aimed to assess the effect of the COVID-19 pandemic in Spain on people with diabetes undergoing cardiac procedures, such as coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), open surgical valve replacement (OSVR), and transcatheter valve implantation (TCVI). We compared the year 2019 with the year 2020. We conducted an observational study using data from the Spanish National Hospital Discharge Database from 1 January 2019 to 31 December 2020. In 2020, a total of 21,067 cardiac procedures were performed on people with diabetes compared with 24,675 in the previous year. The use of CABG, PCI, OSVR and TCVI decreased from 2019 to 2020 by 13.9%, 14.8%, 21.4% and 2.9%, respectively. In 2020, patients had a significantly higher mean Charlson Comorbidity Index than in 2019 for all the cardiac procedures analyzed. In-hospital mortality (IHM) was higher (p > 0.05) for all the procedures in the year 2020. Over the entire period, female sex was a significant risk factor for IHM among those who underwent CABG, PCI and OSVR (OR 1.94, 95%CI 1.41-2.66; OR 1.19, 95%CI 1.05-1.35; and OR 1.79, 95%CI 1.38-2.32, respectively). The sensitivity analysis including two more years, 2017 and 2018, confirmed that female patients and comorbidity were risk factors for IHM in patients with diabetes regardless of whether it was during the pandemic era or before. We conclude that the frequency of cardiac procedures among people with diabetes declined in 2020. IHM did not change significantly in the COVID-19 era.

Sex Differences in Temporal Trends in Hospitalizations and In-Hospital Mortality in Patients with Sarcoidosis in Spain from 2001 to 2020.

(1) Background: We aimed to analyze temporal trends in hospitalization and in-hospital mortality (IHM) in patients with sarcoidosis in Spain from 2001-2020. (2) Methods: Using the Spanish National Hospital Discharge Database, we included patients (aged ≥ 20 years) hospitalized with a sarcoidosis code in any diagnostic field. (3) Results: We included 44,195 hospitalizations with sarcoidosis (56.34% women). The proportion of women decreased over time, from 58.76% in 2001 and 2002 to 52.85% in 2019 and 2020 (p < 0.001). The crude rates per 100,000 inhabitants increased by 4.02% per year among women and 5.88% among men. These increments were confirmed using Poisson regression analysis, which yielded an IRR of 1.03; 95% CI 1.01-1.04 for women and 1.04; 95% CI 1.02-1.06 for men. During the study period, no significant sex differences in IHM were recorded. Older age, COVID-19, respiratory failure, and the need for mechanical ventilation were independent predictors of IHM in men and women hospitalized with sarcoidosis, with IHM remaining stable over time. (4) Conclusions: The number of hospital admissions among patients with sarcoidosis in Spain increased threefold from 2001 to 2020. Although the incidence rates were higher in women, the trend followed that the incidence rates between sexes became closer. IHM was similar among men and women, with no significant change over time in either sex after multivariable analysis.

Impact of the COVID-19 Pandemic on the Use and Outcomes of Cardiac Procedures in COPD Patients.

(1) Background: The aim of this study was to assess the effects of the COVID-19 pandemic on the use and outcomes of cardiac procedures among people with chronic obstructive pulmonary disease (COPD) in Spain. (2) Methods: We used national hospital discharge data to select patients admitted to hospital with a diagnosis of COPD from 1 January 2019 to 31 December 2020. (3) Results: The number of COPD patients hospitalized in 2019 who underwent a cardiac procedure was 4483, 16.2% higher than in 2020 (n = 3757). The length of hospital stay was significantly lower in 2020 than in 2019 (9.37 vs. 10.13 days; p = 0.004), and crude in-hospital mortality (IHM) was significantly higher (5.32% vs. 4.33%; p = 0.035). Multivariable logistic regression models to assess the differences in IHM from 2019 to 2020 showed Odds Ratio (OR) values over 1, suggesting a higher risk of dying in 2020 compared to in 2019. However, the ORs were only statistically significant for "any cardiac procedure" (1.18, 95% CI 1.03-1.47). The Charlson comorbidity index increased IHM for each of the procedures analyzed. The probability of IHM was higher for women and older patients who underwent coronary artery bypass graft or open valve replacement procedures. Suffering a COVID-19 infection was associated with significantly higher mortality after cardiac procedures. (4) Conclusions: The COVID-19 pandemic limited the access to healthcare for patients with COPD.

Sex Differences in COVID-19 Hospitalization and Hospital Mortality among Patients with COPD in Spain: A Retrospective Cohort Study.

(1) Background: We aimed to assess the effect of COPD in the incidence of hospital admissions for COVID-19 and on the in-hospital mortality (IHM) according to sex. (2) Methods: We used national hospital discharge data to select persons aged ≥40 years admitted to a hospital with a diagnosis of COVID-19 in 2020 in Spain. (3) Results: The study population included 218,301 patients. Age-adjusted incidence rates of COVID-19 hospitalizations for men with and without COPD were 10.66 and 9.27 per 1000 persons, respectively (IRR 1.14; 95% CI 1.08-1.20; p < 0.001). The IHM was higher in men than in women regardless of the history of COPD. The COPD was associated with higher IHM among women (OR 1.09; 95% CI 1.01-1.22) but not among men. The COPD men had a 25% higher risk of dying in the hospital with COVID-19 than women with COPD (OR 1.25, 95% CI 1.1-1.42). (4) Conclusions: Sex differences seem to exist in the effect of COPD among patients suffering COVID-19. The history of COPD increased the risk of hospitalization among men but not among women, and COPD was only identified as a risk factor for IHM among women. In any case, we observed that COPD men had a higher mortality than COPD women. Understanding the mechanisms underlying these sex differences could help predict the patient outcomes and inform clinical decision making to facilitate early treatment and disposition decisions.

Impact of Type 2 Diabetes Mellitus on the Incidence and Outcomes of COVID-19 Needing Hospital Admission According to Sex: Retrospective Cohort Study Using Hospital Discharge Data in Spain, Year 2020.

(1) Background: To analyze incidence and in-hospital mortality (IHM) of COVID-19 needing hospital admission in Spain (2020) in patients with T2DM. (2) Methods: We conducted a retrospective cohort study. Using the Spanish Register of Specialized Care-Basic Minimum Database we estimated age-adjusted incidence rates (IR). (3) Results: We included 203,488 patients (56.77% men), of whom 45,620 (22.41%) had T2DM. Age-adjusted IRs/1000 for men with and without T2DM was 12.90 and 5.87, respectively (IRR 2.20; 95% CI 2.18-2.22; p < 0.001), and for women with and without T2DM was 9.23 and 4.27, respectively (IRR 2.16; 95% CI 2.13-2.19; p < 0.001). Crude IHM was 23.86% in people with T2DM, and 15.94% in non-T2DM people (p < 0.001). After matching, intensive-care admission (7.37% vs. 6.15%; p < 0.001) and IHM (23.37% vs. 20.41%; p < 0.001) remained higher in women with T2DM. After matching, IHM among T2DM men was 1.5% higher than among non-T2DM men (24.27% vs. 22.72%; p < 0.001). Men with T2DM had a 34% higher IHM than women with T2DM. Prevalent T2DM increased IHM among women (1.09; 95% 1.03-1.16) and men (1.05; 95% 1.01-1.10). (4) Conclusions: Incidence rates of COVID-19 needing hospital admission were higher in men vs. women, and for people with T2DM vs. non-T2DM. Men had higher IHM beside T2DM status. Prevalent T2DM was associated with higher IHM for both sexes.

Time Trends (2012-2020), Sex Differences and Predictors for Influenza Vaccination Uptake among Individuals with Chronic Obstructive Pulmonary Disease in Spain.

(1) Background: To analyze time trends, sex differences, and factors associated with influenza vaccination uptake among individuals with COPD in Spain, 2012-2020. (2) Methods: A cross-sectional study based on data from the European Health Surveys for Spain, 2020 (EHSS2020) and 2014 and from the Spanish National Health Interview Surveys for 2017 and 2012. (3) Results: The study included 65,447 participants. Prevalence of COPD was 5.9% (n = 3855). Overall, the influenza vaccination uptake among COPD patients was 57.8% versus 28.6% for those without COPD (p < 0.001). Men with COPD reported higher uptake than women in all the surveys studied. Neither the crude nor the multivariable analysis showed a significant variation change overtime for people with COPD. However, among those aged <65 years, crude uptake decreased from 2012 to 2020 (39.4% vs. 33.3%; p = 0.039). Over the entire period, men were vaccinated significantly more than women (OR 1.28; 95% CI 1.12-1.47). Among COPD participants, included in the EHSS2020, independent predictors of vaccine uptake included being male, higher age, reporting no current smoking and suffering cancer or heart disease. (4) Conclusions: In COPD patients, the influenza vaccination uptake is below desirable levels and did not improve from 2012 to 2020. Sex differences are found, with consistent and constant lower uptake among women with COPD. The observed lower uptake among COPD women and patients with unhealthy lifestyle requires increased attention.

Influenza vaccination uptake among high-risk target groups and health care workers in Spain and change from 2017 to 2020.

OBJECTIVE: Using the 2020 European Health Survey for Spain (EHSS2020), which ran from July 2019 to July 2020, we aimed to describe influenza vaccination uptake among the following target groups; individuals aged ≥65 years, health care workers (HCWs), and persons with high-risk chronic medical conditions. We analyzed changes in uptake since the previous Spanish National Health Interview Survey conducted in 2017 and identified variables associated with vaccine uptake. METHODS: We performed a cross-sectional study. The primary study variable was the self-reported uptake of influenza vaccine in the previous year. We analyzed sex, age, country of birth, and being an HCW. We identified participants with self-reported respiratory diseases, cardiovascular disease, diabetes, cancer, and cerebrovascular diseases. Multivariable logistic regression was applied to assess changes over time and to identify variables associated with vaccination in target groups. RESULTS: Uptake was 19.2% in 22,072 participants aged ≥15 years. Uptake was 54.4% for those aged ≥65 years, 41.6% for those with a high-risk medical condition, and 26.53% among HCWs. Uptake by disease was 52.1% for cerebrovascular diseases, 51.3% for cardiovascular diseases, 48.3% for diabetes, 46.1% for cancer, and 36.2% for respiratory diseases. No significant improvement has been observed since 2017 in any target group, except for participants with cancer, whose uptake increased from 33.2% to 46.1%(p < 0.001). The variables that significantly increased the probability of reporting vaccine uptake were female sex, age ≥35 years, being born in Spain, self-reported respiratory or cardiovascular diseases, diabetes, cancer, and being a HCW. CONCLUSIONS: Influenza vaccination uptake among target groups in Spain is below desirable levels and has not improved significantly since 2017. Older age, female sex, and being born in Spain are positive predictors of vaccine uptake. The COVID-19 pandemic highlights the urgent need to implement new strategies to increase influenza vaccine uptake.

Long-term follow-up of patients with venous thromboembolism and COVID-19: Analysis of risk factors for death and major bleeding.

INTRODUCTION: COVID-19 predisposes patients to a higher risk of venous thromboembolism (VTE), although the extent of these implications is unclear and the risk of bleeding has been poorly evaluated. To date, no studies have reported long-term outcomes of patients with COVID-19 and VTE. METHOD: Prospective observational study to evaluate long-term (90 days or more) outcomes of patients diagnosed with VTE (PE, DVT of the extremities, or both) in the setting of COVID-19. The main outcome of the study was a compound of major bleeding and death. RESULTS: The study comprised 100 patients (mean age 65 ± 13.9 years). At the time of VTE diagnosis, 66% patients were hospitalized, 34.8% of them in the ICU. Mean follow-up was 97.9 ± 23.3 days. During the study period, 24% patients died and median time to death was 12 (IQR: 2.25-20.75) days, 11% patients had major bleeding and median time to event was 12 (IQR: 5-16) days. The cause of death was PE in 5% and bleeding in 2% of patients. There were no VTE recurrences. The main study outcome occurred in 29% patients. Risk of death or major bleeding was independently associated with ICU admission (HR 12.2; 95% CI 3.0-48.3), thrombocytopenia (HR 4.5; 95% CI 1.2-16.5), and cancer (HR 21.6; 95% CI 1.8-259). CONCLUSION: In patients with COVID-19 and VTE, mortality and major bleeding were high and almost a third of deaths were VTE-related. The majority of complications occurred in the first 30 days. ICU admission, thrombocytopenia, and cancer are risk factors for poor prognosis.