The impact of COVID-19 on breastfeeding rates: An international cross-sectional study.

BACKGROUND: Breastfeeding promotes children's health and is associated with positive effects to maternal physical and mental health. Uncertainties regarding SARS-CoV-2 transmission led to worries experienced by women and health professionals which impacted breastfeeding plans. We aimed to investigate the impact of self-reported and country-specific factors on breastfeeding rates during the COVID-19 pandemic. METHODS: This study is part of a broader international prospective cohort study about the impact of the COVID-19 pandemic on perinatal mental health (Riseup-PPD-COVID-19). We analysed data from 5612 women, across 12 countries. Potential covariates of breastfeeding (sociodemographic, perinatal, physical/mental health, professional perinatal care, changes in healthcare due to the pandemic, COVID-19 related, breastfeeding support, governmental containment measures and countries' inequality levels) were studied by Generalized Linear Mixed-Effects Models. RESULTS: A model encompassing all covariates of interest explained 24% of the variance of breastfeeding rates across countries (first six months postpartum). Overall, first child (ß = -0.27), age of the child (ß = -0.29), preterm birth (ß = -0.52), admission to the neonatal/pediatric care (ß = -0.44), lack of breastfeeding support (ß = -0.18), current psychiatric treatment (ß = -0.69) and inequality (ß = -0.71) were negatively associated with breastfeeding (p < .001). Access to postnatal support groups was positively associated with breastfeeding (ß = 0.59; p < .001). In countries with low-inequality, governmental measures to contain virus transmission had a deleterious effect on breastfeeding (ß = -0.16; p < .05) while access to maternity leave protected breastfeeding (ß = 0.50; p < .001). DISCUSSION: This study shows that mother's COVID-19 diagnosis and changes in healthcare and birth/postnatal plans did not influence breastfeeding rates. Virtual support groups help women manage breastfeeding, particularly when their experiencing a first child and for those under psychiatric treatment. The complex associations between covariates and breastfeeding vary across countries, suggesting the need to define context-specific measures to support breastfeeding.

A cross-country study on the impact of governmental responses to the COVID-19 pandemic on perinatal mental health.

This study aimed to analyse the role of governmental responses to the coronavirus disease 2019 (COVID-19) outbreak, measured by the Containment and Health Index (CHI), on symptoms of anxiety and depression during pregnancy and postpartum, while considering the countries' Inequality-adjusted Human Development Index (IHDI) and individual factors such as age, gravidity, and exposure to COVID-19. A cross-sectional study using baseline data from the Riseup-PPD-COVID-19 observational prospective international study (ClinicalTrials.gov: NCT04595123) was carried out between June and October 2020 in 12 countries (Albania, Brazil, Bulgaria, Chile, Cyprus, Greece, Israel, Malta, Portugal, Spain, Turkey, and the United Kingdom). Participants were 7645 pregnant women or mothers in the postpartum period-with an infant aged up to 6 months-who completed the Edinburgh Postnatal Depression Scale (EPDS) or the Generalised Anxiety Disorder Assessment (GAD-7) during pregnancy or the postpartum period. The overall prevalence of clinically significant depression symptoms (EPDS ≥ 13) was 30%, ranging from 20,5% in Cyprus to 44,3% in Brazil. The prevalence of clinically significant anxiety symptoms (GAD-7 ≥ 10) was 23,6% (ranging from 14,2% in Israel and Turkey to 39,5% in Brazil). Higher symptoms of anxiety or depression were observed in multigravida exposed to COVID-19 or living in countries with a higher number of deaths due to COVID-19. Furthermore, multigravida from countries with lower IHDI or CHI had higher symptoms of anxiety and depression. Perinatal mental health is context-dependent, with women from more disadvantaged countries at higher risk for poor mental health. Implementing more restrictive measures seems to be a protective factor for mental health, at least in the initial phase of the COVID-19.

Longitudinal relationship of liver injury with inflammation biomarkers in COVID-19 hospitalized patients using a joint modeling approach.

The mechanisms underlying liver disease in patients with COVID-19 are not entirely known. The aim is to investigate, by means of novel statistical techniques, the changes over time in the relationship between inflammation markers and liver damage markers in relation to survival in COVID-19. The study included 221 consecutive patients admitted to the hospital during the first COVID-19 wave in Spain. Generalized additive mixed models were used to investigate the influence of time and inflammation markers on liver damage markers in relation to survival. Joint modeling regression was used to evaluate the temporal correlations between inflammation markers (serum C-reactive protein [CRP], interleukin-6, plasma D-dimer, and blood lymphocyte count) and liver damage markers, after adjusting for age, sex, and therapy. The patients who died showed a significant elevation in serum aspartate transaminase (AST) and alkaline phosphatase levels over time. Conversely, a decrease in serum AST levels was observed in the survivors, who showed a negative correlation between inflammation markers and liver damage markers (CRP with serum AST, alanine transaminase [ALT], and gamma-glutamyl transferase [GGT]; and D-dimer with AST and ALT) after a week of hospitalization. Conversely, most correlations were positive in the patients who died, except lymphocyte count, which was negatively correlated with AST, GGT, and alkaline phosphatase. These correlations were attenuated with age. The patients who died during COVID-19 infection displayed a significant elevation of liver damage markers, which is correlated with inflammation markers over time. These results are consistent with the role of systemic inflammation in liver damage during COVID-19.

Long-term cardiac reverse remodeling after cardiac resynchronization therapy.

INTRODUCTION: The benefit of cardiac resynchronization therapy (CRT) in heart failure (HF) patients with reduced left ventricular ejection fraction (LVEF) have been observed in the first year. However, there are few data on long-term follow-up and the effect of changes of LVEF on mortality. This study aimed to assess the LV remodeling after CRT implantation and the probable effect of changes in LVEF with repeated measures on mortality over time in a real-world registry. METHODS: Among our cohort of 328 consecutive CRT patients, mixed model effect analysis have been made to describe the temporal evolution of LVEF and LVESV changes over time up with several explanatory variables. Besides, the effect of LVEF along time on the probability of mortality was evaluated using joint modeling for longitudinal and survival data. RESULTS: The study population included 328 patients (253 men; 70.2 ± 9.5 years) in 4.2 (2.9) years follow-up. There was an increase in LVEF of 11% and a reduction in LVESV of 42 mL during the first year. These changes are more important during the first year, but slight changes remain during the follow-up. The largest reduction in LVESV occurred in patients with left bundle branch block (LBBB) and the smallest reduction in patients with NYHA IV. The smallest increase in LVEF was an ischemic etiology, longer QRS, and LV electrode in a nonlateral vein. Besides, the results showed that the LVEF profiles taken during follow-up after CRT were associated with changes in the risk of death. CONCLUSION: Reverse remodeling of the left ventricle is observed especially during the first year, but it seems to be maintained later after CRT implantation in a contemporary cohort of patients. Longitudinal measurements could give us additional information at predicting the individual mortality risk after adjusting by age and sex compared to a single LVEF measurement after CRT.

Volumetric Absorptive Microsampling (VAMS) for assaying immunosuppressants from venous whole blood by LC-MS/MS using a novel atmospheric pressure ionization probe (UniSpray™).

Therapeutic drug monitoring (TDM) of immunosuppressants (IMS) is crucial to prevent rejection or toxicity after solid organ transplantation. Microsampling techniques (sampling <50 µL of blood) can be a good alternative to conventional venous sampling for TDM, due to their numerous advantages, including its easy and low-invasive sampling, enabling self-collection, and cost-saving shipment and storage. Furthermore, volumetric absorptive microsampling (VAMS) enables the collection of precise and accurate blood volumes, overcoming the hematocrit (Hct) effect related to dried blood spots, while offering the same benefits. In this work, an LC-MS/MS method for the determination of the 5 most common IMS (mycophenolic acid -MPA-, tacrolimus -TAC-, sirolimus -SIR-, everolimus -EVE- and cyclosporin A -CsA-) in venous blood collected with Mitra™ VAMS devices was developed and validated, employing a novel LC-MS/MS interface, Unispray™. The method was fully validated including linearity, limits of detection (LOD) and quantification (LLOQ), accuracy, precision, selectivity, carry-over, matrix effect, recovery, impact of Hct on recovery and autosampler and short-/long-term stability, satisfying acceptance criteria in all cases. LLOQs were 0.5 ng/mL for TAC, SIR and EVE, 20 ng/mL for CsA and 75 ng/mL for MPA. No impact of the Hct (range: 0.2 to 0.62 L/L) on recovery was found for any analyte. All compounds were stable in VAMS for at least 8 months at -20 °C. In addition, as part of the VAMS analytical method validation, we performed for the first time a broad statistical study to compare liquid venous blood concentrations from patients under TAC (n = 53) and MPA (n = 20) treatment to those observed when the same specimens were absorbed into VAMS. Our results showed that venous blood VAMS concentrations were correlated to those found in the original liquid venous blood, proving that the VAMS material itself will not bias blood drug concentrations. Therefore, the present method could be applied to evaluate possible correlations between venous blood and capillary blood collected with VAMS.

Improvement in VO2peak predicts readmissions for cardiovascular disease and mortality in patients undergoing cardiac rehabilitation.

BACKGROUND: Improvement in exercise capacity is a main goal of cardiac rehabilitation but the effects are often lost at long-term follow-up and thus also the benefits on prognosis. We assessed whether improvement in VO2peak during a cardiac rehabilitation programme predicts long-term prognosis. METHODS AND RESULTS: We performed a retrospective analysis of 1561 cardiac patients completing cardiac rehabilitation in 2011-2017 in Copenhagen. Mean age was 63.6 (11) years, 74% were male and 84% had coronary artery disease, 6% chronic heart failure and 10% heart valve replacement. The association between baseline VO2peak and improvement after cardiac rehabilitation and being readmitted for cardiovascular disease and/or all-cause mortality was assessed with three different analyses: Cox regression for the combined outcome, for all-cause mortality and a multi-state model. During a median follow-up of 2.3 years, 167 readmissions for cardiovascular disease and 77 deaths occurred. In adjusted Cox regression there was a non-linear decreasing risk of the combined outcome with higher baseline VO2peak and with improvement of VO2peak after cardiac rehabilitation. A similar linear association was seen for all-cause mortality. Applying the multi-state model, baseline VO2peak and change in VO2peak were associated with risk of a cardiovascular disease readmission and with all-cause mortality but not with mortality in those having an intermediate readmission for cardiovascular disease. CONCLUSION: VO2peak as well as change in VO2peak were highly predictive of future risk of readmissions for cardiovascular disease and all-cause mortality. The predictive value did not extend beyond the next admission for a cardiovascular event.

Cardiac resynchronization therapy outcomes in patients under nonoptimal medical therapy.

BACKGROUND: Cardiac resynchronization therapy (CRT) is indicated in symptomatic heart failure (HF) patients after achieving optimal medical therapy (OMT). However, many patients may not be under OMT when the CRT device is implanted. Here, we evaluate the long-term benefits of CRT in symptomatic HF patients receiving or not OMT. METHODS: We investigated the effect of OMT on HF developing or death in 328 consecutive patients with a CRT device implanted between 2005 and 2015 in a single tertiary center. After the CRT implant, we categorized the patients into three groups: no OMT, OMT at baseline and after 1 year of follow-up, and OMT only at the 1-year follow-up but not at baseline. We used multivariate Cox proportional hazards model to determine the effect of OMT on clinical outcomes. RESULTS: One hundred and twenty-two patients (37.2%) received OMT prior to CRT. OMT at baseline was not associated with a reduced risk of death or HF (HR 0.72; 95% CI 0.50-1.02; P = 0.067) compared with no-basal-OMT patients. After CRT, patients without OMT had a higher risk of death or HF than patients who received OMT in follow-up (HR 1.72, 95% CI 1.07-2.78, P = 0.025), and the risk of the patients who received OMT at baseline and at the 1-year follow-up was similar to that of the patients who achieved OMT at the 1-year follow-up (HR 0.90, 95% CI 0.54-1.50, P = 0.682). CONCLUSION: Basal OMT prior to CRT is not associated with better outcomes in terms of HF/death compared with no basal OMT. The subgroup of patients who achieved OMT at the 1-year follow-up exhibited a reduced risk of HF and death compared with patients who did not.

Prognostic value of nutrition status in the response of cardiac resynchronization therapy.

BACKGROUND: Cardiac resynchronization therapy (CRT) is indicated in symptomatic heart failure (HF) patients after achieving optimal medical therapy. However, there are still a large percentage of patients who do not respond to CRT. Malnutrition is a frequent comorbidity in patients with HF, and it is associated with a poorer prognosis. Here, we evaluate the nutritional status of patients assessed by Controlling Nutritional Status (CONUT) score and its association with structural remodeling and cardiovascular events. METHODS: We investigated the effect of CONUT on HF/death in 302 consecutive patients with a CRT device implanted between 2005 and 2015 in a single tertiary center. We categorized the patients into three groups: normal nutritional status (CONUT 0-1), mild malnutrition (CONUT 2-4) and moderate-severe malnutrition (CONUT ≥ 5). Changes in nutritional status were assessed in patients with mild-to-severe malnutrition prior to CRT. RESULTS: One hundred and forty-eight patients exhibited normal nutritional status (49.0%), 99 patients exhibited mild malnutrition (32.8%) and 55 patients exhibited moderate-severe malnutrition (18.2%). CONUT scores of at least 2 were associated with higher risk of HF/death compared with CONUT 0-1. Significant left ventricular (LV) reverse remodeling was noted in patients with better nutritional status. In addition, those malnutrition patients at baseline that improved nutritional state exhibited fewer HF/death events at follow-up. CONCLUSION: CONUT score prior to CRT was an independent risk factor of death/HF and was correlated with LV reverse remodeling. Improvements in CONUT score during long-term follow-up were associated with a reduction in the rate of HF/death.

Predictive models of malignant transudative pleural effusions.

BACKGROUND: There are no firm recommendations when cytology should be performed in pleural transudates, since some malignant pleural effusions (MPEs) behave biochemically as transudates. The objective was to assess when would be justified to perform cytology on pleural transudates. METHODS: Consecutive patients with transudative pleural effusion (PE) were enrolled and divided in two groups: malignant and non-MPE. Logistic regression analysis was used to estimate the probability of malignancy. Two prognostic models were considered: (I) clinical-radiological variables; and (II) combination of clinical-radiological and analytical variables. Calibration and discrimination [receiver operating characteristics (ROC) curves and area under the curve (AUC)] were performed. RESULTS: A total of 281 pleural transudates were included: 26 malignant and 255 non-malignant. The AUC obtained with Model 1 (left PE, radiological images compatible with malignancy, absence of dyspnea, and serosanguinous appearance of the fluid), and Model 2 (the variables of Model 1 plus CEA) were 0.973 and 0.995, respectively. Although no false negatives are found in Models 1 and 2 to probabilities of 11% and 14%, respectively, by applying bootstrapping techniques to not find false negatives in 95% of other possible samples would require lowering the cut-off points for the aforementioned probabilities to 3% (Model 1) and 4% (Model 2), respectively. The false positive results are 32 (Model 1) and 18 (Model 2), with no false negatives. CONCLUSIONS: The applied models have a high discriminative ability to predict when a transudative PE may be of neoplastic origin, being superior to adding an analytical variable to the clinic-radiological variables.

Acute focal bacterial nephritis in a cohort of hospitalized adult patients with acute pyelonephritis. Assessment of risk factors and a predictive model.

BACKGROUND: Acute focal bacterial nephritis (AFBN) is a complicated form of acute pyelonephritis (APN) characterized by single or multiple areas of localised infection in the kidney without liquefaction or abscess. Studies investigating AFBN in adults are scarce. AIM: The present study was aimed at evaluating the prevalence, associated factors, and presence of atypical clinical and radiological manifestations in adult AFBN patients. Also, we developed a clinical prediction model to evaluate the probability of AFBN in patients with APN. METHODS: The clinical records of 377 patients (mean age 54years, 74.0% females) admitted to a hospital over a 5-year period with APN were reviewed. RESULTS: A total of 57 cases of AFBN were radiologically identified (prevalence, 15.1%). Patients with AFBN were younger and displayed atypical manifestations more frequently than patients without AFBN; these included both clinical and radiological (pleural effusion, gallbladder wall thickening, fluid around the gallbladder, perirenal fluid, and ascites) manifestations. Patients with AFBN showed lower systolic blood pressure and needed more days of therapy to become afebrile, longer total duration of antibiotic therapy, and longer hospital stay than patients without AFBN. Contraceptive use was more frequent in patients with AFBN. A model based on five clinical variables showed good discrimination performance for the diagnosis of AFBN (Area under the curve, 0.77 (95% CI, 0.69-0.89)). CONCLUSIONS: Patients with AFBN frequently present with atypical clinical and radiological manifestations. Clinical presentation by means of a predictive model may predict the presence of AFBN. Patients with AFBN need more intensive therapy, which is followed by a favourable outcome.