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Few prospective studies have assessed the safety of direct oral anticoagulants (DOACs) in elective endoscopy. Our primary aim was to compare the risks of endoscopy-related gastrointestinal bleeding and thromboembolic events in patients on DOACs or vitamin K antagonists (VKAs) in this setting. Secondarily, we examined the impact of the timing of anticoagulant resumption on the risk of delayed bleeding in high-risk therapeutic procedures. We conducted a multicenter, prospective, observational study from January 2018 to March 2020 of 1602 patients on oral anticoagulants (1004 on VKAs and 598 on DOACs) undergoing 1874 elective endoscopic procedures. Our primary outcomes were 90-day thromboembolic events and 30-day endoscopy-related gastrointestinal bleeding. The inverse probability of treatment weighting propensity score method was used for baseline covariate adjustment. The 2 groups had similar risks of endoscopy-related gastrointestinal bleeding (VKAs vs DOACs, 6.2% vs 6.7%; adjusted odds ratio [OR], 1.05; 95% CI, 0.67–1.65) and thromboembolic events (VKAs vs DOACs, 1.3% vs 1.5%; adjusted OR, 0.90; 95% CI, 0.34–2.38). In high bleeding risk procedures (n = 747), delayed anticoagulant resumption (> 48 hours or 24–48 hours vs < 24 hours) did not reduce the risk of postprocedural bleeding (10.3%, 9%, and 5.8%, respectively; adjusted P =.43). Hot and cold snare polypectomy were the most frequent high-risk interventions (41.8% and 39.8%, respectively). In a prospective study of patients on DOACs or VKAs undergoing elective endoscopy, endoscopy-related bleeding and thromboembolic events showed similar risk. Our study suggests that early anticoagulant resumption is safe in most patients, but more data are needed for advanced high-risk therapeutic procedures. [Display omitted] [ABSTRACT FROM AUTHOR]

Tocilizumab has been proposed as a candidate therapy for patients with severe coronavirus disease 2019 (COVID-19), especially among those with higher systemic inflammation. We investigated the association between receipt of tocilizumab and mortality in a large cohort of hospitalized patients. In this cohort study of patients hospitalized with COVID-19 in Spain, the primary outcome was time to death and the secondary outcome time to intensive care unit (ICU) admission or death. We used inverse probability weighting to fit marginal structural models adjusted for time-varying covariates to determine the causal relationship between receipt of tocilizumab and outcome. Data from 1229 patients were analysed, with 261 patients (61 deaths) in the tocilizumab group and 969 patients (120 deaths) in the control group. In the adjusted marginal structural models, a significant interaction between receipt of tocilizumab and high C-reactive protein (CRP) levels was detected. Tocilizumab was associated with decreased risk of death (adjusted hazard ratio 0.34, 95% confidence interval 0.16–0.72, p 0.005) and ICU admission or death (adjusted hazard ratio 0.39, 95% confidence interval 0.19–0.80, p 0.011) among patients with baseline CRP >150 mg/L but not among those with CRP ≤150 mg/L. Exploratory subgroup analyses yielded point estimates that were consistent with these findings. In this large observational study, tocilizumab was associated with a lower risk of death or ICU admission or death in patients with higher CRP levels. While the results of ongoing clinical trials of tocilizumab in patients with COVID-19 will be important to establish its safety and efficacy, our findings have implications for the design of future clinical trials. [ABSTRACT FROM AUTHOR]

Copyright of Revista Española de Cardiología (18855857) is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Objectives The aim of this study was to assess the effectiveness of inferior vena cava (IVC) filter use among patients who develop recurrent symptomatic venous thromboembolism (VTE) on anticoagulant therapy. Background There is a lack of efficacy evidence of IVC filter therapy in patients with VTE recurrence on anticoagulant therapy. Methods In this cohort study of patients with acute VTE identified from the RIETE (Registro Informatizado de la Enfermedad Tromboembólica) registry, the associations between IVC filter placement for VTE recurrence in the first 3 months of anticoagulant therapy and the outcomes of all-cause mortality, pulmonary embolism (PE)–related mortality, second recurrent VTE, and major bleeding rates through 30 days after diagnosis of recurrence were assessed. Results Among 17 patients treated with filters and 49 matched patients treated without filters for VTE recurrence that presented as deep vein thrombosis, propensity score–matched groups showed no significant differences in death for filter insertion compared with no insertion (17.7% vs. 12.2%; p = 0.56). Among 48 patients treated with filters and 91 matched patients treated without filters for VTE recurrence that presented as PE, propensity score–matched groups showed a significant decrease in all-cause death for filter insertion compared with no insertion (2.1% vs. 25.3%; p = 0.02). The PE-related mortality rate was not significantly lower for filter insertion than no insertion (2.1% vs. 17.6%; p = 0.08), though the point estimates markedly differed. Conclusions Among patients with VTE recurrence during the first 3 months of anticoagulant therapy, IVC filter insertion was not associated with a survival benefit in patients who recurred with deep vein thrombosis, although it was associated with a lower risk for all-cause death in patients who recurred with PE. [ABSTRACT FROM AUTHOR]

Introduction: It has been debated whether the penumbral pattern, as identified using multimodal imaging, is a specific marker of tissue viability in ischemic stroke. We assessed whether perfusion computed tomography (PCT) accurately identifies salvageable tissue and helps predict postreperfusion outcomes.Methods: A retrospective study of patients with anterior circulation stroke undergoing reperfusion therapies who had a PCT before treatment and an assessment of vessel recanalization post treatment was conducted. Tissue at risk was considered as that with reduced cerebral blood flow, whereas the infarct core was the region of reduced cerebral blood volume, the mismatch region being salvageable tissue. The volume of hypodensity in slices corresponding to perfusion acquisition cage in 24-hour computed tomography (partial lesion volume [PLV]) was measured. Outcome variables were the amount of preserved tissue, that is, the difference between volumes of tissue at risk and PLV expressed as a percentage, and the modified Rankin Scale (mRS) score at 3 months.Results: Patients (n = 34) meeting the inclusion criteria were included. Vessel recanalization was associated with a larger amount of tissue at risk preserved from definite lesion (89% [interquartile range {IQR}: 76-94] versus 46% [IQR: 23-86], P < .005). The amount of preserved tissue correlated with clinical outcome at 24 hours: for each 10% of preserved tissue, the National Institutes of Health Stroke Scale score improved by 3 points (95% confidence interval [CI]: -4.9 to -.8, P = .007) and was the only predictor of independency (mRS score 0-2) following adjustment for covariates (odds ratio 1.15, 95% CI: 1.04-1.28, P = .005).Conclusions: PCT provides accurate markers of viability of tissue in acute ischemic stroke and could help predict the degree of improvement following reperfusion. [ABSTRACT FROM AUTHOR]

Solid organ transplantation is the treatment of choice for patients with end-stage organ disease. However, organ transplantation can stress the cardiovascular system and decrease immune surveillance, leading to early mortality and graft loss due to multiple underlying comorbidities. Clinical end-points in transplant include death and graft failure. Thus, generating accurate predictive models through regression models is crucial to test for definitive clinical post-transplantation end-points. Survival predictive models should assemble efficient surrogate markers or prognostic factors to generate a minimal set of variables derived from a proper modeling strategy through regression models. However, a few critical points should be considered when reporting survival analyses and regression models to achieve proper discrimination and calibration of the predictive models. Additionally, population-based risk scores may underestimate risk prediction in transplant. The application of predictive models in these patients should therefore incorporate both classical and non-classical risk factors, as well as community-based health indicators and transplant-specific factors to quantify the outcomes in terms of survival properly. This review focuses on assessment of clinical end-points in transplant through regression models by combining predictive and surrogate variables, and considering key points in these analyses to accurately predict definitive end-points, which could aid clinicians in decision making. [ABSTRACT FROM AUTHOR]

Objectives: The purpose of this study was to investigate the survival effects of inferior vena cava filters in patients with venous thromboembolism (VTE) who had a significant bleeding risk. Background: The effectiveness of inferior vena cava filter use among patients with acute symptomatic VTE and known significant bleeding risk remains unclear. Methods: In this prospective cohort study of patients with acute VTE identified from the RIETE (Computerized Registry of Patients With Venous Thromboembolism), we assessed the association between inferior vena cava filter insertion for known significant bleeding risk and the outcomes of all-cause mortality, pulmonary embolism (PE)-related mortality, and VTE rates through 30 days after the initiation of VTE treatment. Propensity score matching was used to adjust for the likelihood of receiving a filter. Results: Of the 40,142 eligible patients who had acute symptomatic VTE, 371 underwent filter placement because of known significant bleeding risk. A total of 344 patients treated with a filter were matched with 344 patients treated without a filter. Propensity score–matched pairs showed a nonsignificant trend toward lower risk of all-cause death for filter insertion compared with no insertion (6.6% vs. 10.2%; p = 0.12). The risk-adjusted PE-related mortality rate was lower for filter insertion than no insertion (1.7% vs. 4.9%; p = 0.03). Risk-adjusted recurrent VTE rates were higher for filter insertion than for no insertion (6.1% vs. 0.6%; p < 0.001). Conclusions: In patients presenting with VTE and with a significant bleeding risk, inferior vena cava filter insertion compared with anticoagulant therapy was associated with a lower risk of PE-related death and a higher risk of recurrent VTE. However, study design limitations do not imply a causal relationship between filter insertion and outcome. [Copyright &y& Elsevier]

Objectives: We reviewed publications with two main objectives: to describe how survival analyses are reported across medical journal specialties and to evaluate changes in reporting across periods and journal specialties. Study Design and Setting: Systematic review of clinical research articles published in 1991 and 2007, in 13 high-impact medical journals. Results: The number of articles performing survival analysis published in 1991 (104) and 2007 (240) doubled (17% vs. 33.5%; P 5 0.000), although not uniformly across specialties. The percentage of studies using regression models and the number of patients included also increased. The presentation of results improved, although only the reporting of precision of effect estimates reached satisfactory levels (53.1% in 1991 vs. 94.2% in 2007; P 5 0.000). Quality of reporting also varied across specialties; for example, cardiology articles were less likely than oncology ones to discuss sample size estimation (odds ratio 5 0.12; 95% confidence interval: 0.05, 0.30). We also detected an interaction effect between period and specialty regarding the likelihood of reporting precision of curves and precision of effect estimates. Conclusion: The application of survival analysis to medical research data is increasing, whereas improvement in reporting quality is slow. We propose a list of minimum requirements for improved application and description of survival analysis. [ABSTRACT FROM AUTHOR]

Various risk assessment tools have been proposed to identify stable patients with acute pulmonary embolism (PE) who are at high risk of early adverse outcome (i.e., intermediate-high risk). We evaluated the ability of the 2019 ESC, Bova, modified FAST and PEITHO-3 models for predicting a 30-day complicated course (death, haemodynamic collapse, and/or recurrent PE) in a cohort of 848 stable patients with acute PE. We also tested whether replacement of echocardiographic right ventricle (RV) dysfunction by computed tomographic (CT) RV enlargement provides comparable prognostic information for identifying these patients. A complicated course occurred in 63 (7.4 %) of the 848 patients with PE during the first month of follow-up. The proportion of patients designated as having intermediate-high risk PE was 6.7 % with the ESC model, 4.4 % with the Bova score, 15.7 % with the FAST score, and 5.2 % with the PEITHO-3 model. However, among patients identified as intermediate-high risk, the 30-day complicated course rate was higher with the Bova score (21.6 %) than with the ESC model (17.5 %), the PEITHO-3 model (15.9 %), or the modified FAST score (14.3 %). When echocardiographic RV dysfunction was replaced by CT RV enlargement in the models, the proportion of patients classified as having intermediate-high risk PE and the rate of an adverse outcome among them slightly increased. The Bova score might identify patients with intermediate-high risk PE slightly better than the ESC, PEITHO-3, and modified FAST score. When echocardiography is not readily available, CT-assessed RV enlargement might be used for identifying intermediate-high risk PE. ClinicalTrials.gov number: NCT02238639. • Different scores have been developed for identifying intermediate-high risk patients with acute PE. • The Bova score showed the greatest ability to predict a complicated course among stable patients with acute pulmonary embolism. • Clinicians might consider the use of the Bova score to discuss advanced therapies with patients. [ABSTRACT FROM AUTHOR]

Background: Peptide microarray analysis is a novel method that can provide useful information on the nature of specific allergies. Objective: We sought to determine the specificity and diversity of IgE and IgG4 antibodies binding to sequential epitopes of αs1-, αs2-, β-, and κ-caseins and β-lactoglobulin by using a peptide microarray–based immunoassay. Methods: A microarray immunoassay was performed with sera from 31 children with IgE-mediated milk allergy (16 with positive oral milk challenge results [ie, the reactive group] and 15 with negative oral milk challenge results [ie, the tolerant group]). A library of peptides, consisting of 20 amino acids (AAs) overlapping by 17 (3-offset), corresponding to the primary sequences of αs1-, αs2-, β-, and κ-caseins and β-lactoglobulin was printed on epoxy-coated slides. A region was defined as an epitope if it was statistically associated with reactive groups and recognized by at least 75% of reactive patients. Results: By using this method, a total of 10 epitopes were identified: αs1 , AAs 28 to 50, 75% reactive and 26.7% tolerant; αs2 , AAs 1 to 20, 75% reactive and 13.3% tolerant; AAs 13 to 32, 75% reactive and 26.7% tolerant; AAs 67 to 86, 75% reactive and 33.3% tolerant; and AAs 181 to 207, 75% reactive and 20% tolerant; β-casein, AAs 25 to 50, 75% reactive and 33.3% tolerant, AAs 52 to 74, 81.3% reactive and 26.7% tolerant; and AAs 154 to 173, 75% reactive and 33.3% tolerant; β-lactoglobulin, AAs 58 to 77, 81.3% reactive and 40% tolerant; and κ-casein, AAs 34 to 53, 87.5% reactive and 40% tolerant. Conclusion: Several regions have been defined as epitopes, which showed differential recognition patterns between reactive and tolerant patients. Further studies are needed to validate the utility of this assay in clinical practice. [Copyright &y& Elsevier]

Purpose: To assess the efficacy of neuro-reflexotherapy intervention (NRT) for treating temporomandibular joint dysfunction attributed to myofascial pain. Neuro-reflexotherapy intervention consists of the temporary implantation of epidermal devices in trigger points in the back and ear. It has shown efficacy, effectiveness, and cost-effectiveness in treating subacute and chronic common back pain. No study, however, has explored its efficacy in treating myofascial temporomandibular joint pain (MF/TMJP). Patients and Methods: This was a randomized, double-blind, placebo-controlled trial. Patients with MF/TMJP for more than 3 months in spite of conservative treatment, and with no evidence of major structural damage in the joint, were recruited at the Maxillofacial Department of the Hospital Clínico Universitario, a teaching hospital in Madrid, Spain. Patients were randomly assigned to an intervention group and to a control group. Patients in the treated group underwent 2 NRTs, immediately after baseline assessment and 45 days later. Sham interventions in the control group consisted of placement of the same number of epidermal devices within a 5-cm radius of the target zones. In both groups, conservative treatment during follow-up was allowed and recorded. Patients underwent clinical evaluations on 4 occasions: 5 minutes before intervention, 5 minutes after intervention, and 45 and 90 days later. The preintervention assessment was performed by the physician at the hospital service who included the patient in the study. The 3 follow-up assessments were performed independently by 1 of 2 physicians who had no connection with the research team, and who were blinded to patients'' assignments. The primary outcome variable was level of pain severity during jaw movements at the last assessment (90 days), and the key comparison of interest was change in pain over time (pain levels at baseline and at 90 days). Level of pain was measured using a visual analog scale (VAS). Results: Fifty-one patients with MF/TMJP were recruited into the study. Random assignment allocated 27 patients to the intervention group, and 24 to the control group. Differences in pain severity in favor of the intervention group appeared immediately after the intervention, persisted for 45 days, and increased after the second intervention. Differences at last follow-up were highly clinically and statistically significant (4 to 5 points on the VAS, P = .000), allowing for patients in the intervention group to cease drug treatment (P = .005). There were no differences in the evolution of crepitus or clicking in the joint. There were no clinically relevant side effects associated with the intervention. Conclusions: For patients in whom conservative treatment has failed, NRT improves the chronic pain associated with MF/TMJP syndrome. [Copyright &y& Elsevier]

Copyright of Revista Española de Cardiología (18855857) is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Background A firm mattress is commonly believed to be beneficial for low-back pain, although evidence supporting this recommendation is lacking. We assessed the effect of different firmnesses of mattresses on the clinical course of patients with chronic non-specific low-back pain.Methods In a randomised, double-blind, controlled, multicentre trial, we assessed 313 adults who had chronic non-specific low-back pain, but no referred pain, who complained of backache while lying in bed and on rising. Mattress firmness is rated on a scale developed by the European Committee for Standardisation. The Hs scale starts at 1·0 (firmest) and stops at 10·0 (softest). We randomly assigned participants firm mattresses (Hs=2·3) or medium-firm mattresses (Hs=5·6). We did clinical assessments at baseline and at 90 days. Primary endpoints were improvements in pain while lying in bed, pain on rising, and disability.Findings At 90 days, patients with medium-firm mattresses had better outcomes for pain in bed (odds ratio 2·36 [95% CI 1·13–4·93]), pain on rising (1·93 [0·97–3·86]), and disability (2·10 [1·24–3·56]) than did patients with firm mattresses. Throughout the study period, patients with medium-firm mattresses also had less daytime low-back pain (p=0·059), pain while lying in bed (p=0·064), and pain on rising (p=0·008) than did patients with firm mattresses.Interpretation A mattress of medium firmness improves pain and disability among patients with chronic non-specific low-back pain. [Copyright &y& Elsevier]

The risk of Trypanosoma cruzi reactivation is poorly understood. Previous studies evaluating the risk of reactivation report imprecise findings, and recommendations for monitoring and management from clinical guidelines rely on consensus opinion. We conducted a systematic review and meta-analysis to estimate the cumulative T. cruzi reactivation incidence in immunosuppressed adults, summarize the available evidence on prognostic factors for reactivation, and examine its prognostic effect on mortality. MEDLINE, Embase, LILACS, Clinical Trials, and CENTRAL from inception to 4 July 2022. Studies reporting the incidence of T. cruzi reactivation. Immunosuppressed adults chronically infected by T. cruzi. Two authors independently extracted data (including, but not limited to, incidence data, reactivation definition, follow-up, treatment, monitoring schedule, examined prognostic factors) and evaluated the risk of bias. We pooled cumulative incidence using a random-effects model. Twenty-two studies (806 participants) were included. The overall pooled incidence of T. cruzi reactivation was 27% (95% CI, 19–36), with the highest pooled proportion in the sub-group of transplant recipients (36%; 95% CI, 25–48). The highest risk period was in the first 6 months after transplant (32%; 95% CI, 17–58), decreasing drastically the number of new cases later. People living with HIV and patients with autoimmune diseases experienced significantly lower cumulative reactivation incidences (17%; 95% CI, 8–29 and 18%; 95% CI, 9–29, respectively). A single study explored the independent effect of benznidazole and found benefits for preventing reactivations. No studies evaluated the independent association between reactivation and mortality, while sensitivity analysis results using unadjusted estimates were inconclusive. The heterogeneity of diagnostic algorithms was substantial. Reactivation occurs in three out of ten T. cruzi -seropositive immunosuppressed adults. These findings can assist clinicians and panel guidelines in tailoring monitoring schedules. There is a great need for an accurate definition of reactivation and targeted monitoring. [ABSTRACT FROM AUTHOR]

The Composite Pulmonary Embolism Shock (CPES) score has been developed to identify normotensive patients with acute pulmonary embolism (PE) and a low cardiac index (referred to as normotensive shock). We aimed to externally assess the validity of this model for predicting a complicated course among hemodynamically stable patients with acute PE. Using prospectively collected data from the PROgnosTic valuE of Computed Tomography scan (PROTECT) study, we calculated the CPES score for each patient and the proportion of patients with a score > 3. We calculated the test performance characteristics to predict a complicated course (i.e., death from any cause, hemodynamic collapse, or recurrent PE) and the discriminatory power using the area under the receiver operating characteristic curve. Sixty-three of the 848 (7.4 %) patients had a complicated course during the 30-day follow-up period. Of the 848 enrolled patients, the CPES score was positive (i.e., score > 3) in 78 (9.2 %). The specificity was 92.1 % (723/785), the positive predictive value was 20.5 % (16/78), and the positive likelihood ratio was 3.22 for a complicated course. The areas under the receiver operating characteristic curve for a complicated course were 0.71 (95 % confidence interval [CI], 0.65–0.78). With the higher score risk classification threshold (cutoff score > 4), the proportion of patients designated as positive was 2.1 %, and the specificity was 98.1 %. When echocardiographic right ventricle (RV) dysfunction was replaced by computed tomographic RV enlargement, the specificity was 85.4 %, the positive predictive value was 14.2 %, and the positive likelihood ratio was 2.06 for a complicated course. When analyses were restricted to the subgroup of patients with intermediate-risk PE, the specificity and the positive predictive value for a complicated course were identical to the overall cohort. The CPES score has acceptable C-statistic, excellent specificity, and low positive predictive value for identification of hemodynamic deterioration in normotensive patients with PE. ClinicalTrials.gov number: NCT02238639. • Adequate risk stratification of PE may influence decisions for more intensive vigilance and escalation of treatment. • The CPES score has been developed to identify normotensive patients with acute PE and a low cardiac index. • The CPES score reliably identifies stable patients with PE who might be at risk for hemodynamic deterioration or death. [ABSTRACT FROM AUTHOR]

Chronic thromboembolic pulmonary hypertension (CTEPH) is a long-term sequel to pulmonary embolism (PE) whose incidence varies according to different published studies. We have carried out this study to determine its incidence within 2 years after index pulmonary embolism and to study limitations to an early diagnosis. OSIRIS is a multicentre, longitudinal cohort study. Patients were followed for 3, 6, 12, and 24 months after pulmonary embolism using a structured three-step algorithm. A physician-centered questionnaire at least one positive response in a screening proceeded to the second step, transthoracic echocardiography. The third step consisted of ventilation/perfusion lung scintigraphy and right heart catheterisation. A transthoracic echocardiography was performed in patients without positive response in the screening questionnaire after 2 years. CTEPH diagnosis required haemodynamic confirmation by right heart catheterisation and mismatched perfusion defects on lung scintigraphy. A total of 1191 patients were enrolled in 18 Spanish hospitals. Cumulative CTEPH incidence after 2-years PE was: 2.49 % (95 % CI: 1.68–3.56) and the incidence rate of CTEPH was 1.1 cases per 1000 person-months (95 % CI: 0.725; 1.60). The CTEPH algorithm presented a lack of adherence of 29 %; patient and physician preferences posed barriers to the triage algorithm The screening questionnaire, in patients who completed the follow-up, shows a specificity of 91.3 % (89.0–93.2 %) and negative predictive value of 99.4 % (98.4–99.8 %).. OSIRIS provides practiced clinical based data on the chronic thromboembolic pulmonary hypertension incidence and identified barriers to the implementation of a 3-step triage algorithm for its detection. clinicaltrials.gov identifier: NCT03134898. [Display omitted] • Two-year cumulative incidence of Chronic Thromboembolic Pulmonary Hypertension (CTEPH) after pulmonary embolism (PE) was 2.49% (95% CI: 1.68-3.56) • A structured three-step diagnostic algorithm based on clinical assessment starting with a screening questionnaire showed limited feasibility, but a high negative predictive value • Observed barriers from patients and physicians to the implementation of a screening-based CTEPH diagnostic algorithm may support the planning of future studies and help to address training gaps [ABSTRACT FROM AUTHOR]

Sex is an important factor associated with pulmonary embolism (PE) disease presentation and outcomes, which may be related to pathobiological, social, and treatment-based differences. We are seeking to illuminate sex differences in pulmonary embolism presentation, care, and outcomes using an international registry and a national US database of people 65 years and older, the age group in which the majority of these events occur. The Sex Differences in PrEsentation, Risk Factors, Drug and Interventional Therapies, and OUtcomes of Elderly PatientS with Pulmonary Embolism (SERIOUS-PE) study has been designed to address knowledge gaps in this area. This study will use data from the Registro I nformatizado E nfermedad T rombo E mbolica (RIETE) registry and the US Medicare Fee-For-Service beneficiaries. RIETE is a large international registry of patients with venous thromboembolism with data collected on PE presentation, risk factors, co-morbidities, drug and interventional therapies, as well as 30-day and 1-year outcomes (including recurrent VTE, major bleeding, and mortality). Data from US Medicare Fee-For-Service beneficiaries will be used to understand the sex differences in PE hospitalizations, advanced therapies, and outcomes at 30-day and 1-year follow-up. Assessment of outcomes in both databases will be performed in unadjusted models, as well as those adjusted for demographics, co-morbidities, and treatments, to understand whether the potential sex differences in outcomes are related to differences in risk factors and co-morbidities, potential disparities in treatment, or a plausible biological difference in women versus men. Linear trends will be assessed over time. RIETE data from March 2001 through March 2021 include 33,462 elderly patients with PE, of whom 19,294 (57.7%) were women and 14,168 (42.3%) were men. In the Medicare Fee-For-Service database, between January 2001 and December 31, 2019, 1,030,247 patients were hospitalized with a principal discharge diagnosis of PE, of whom 599,816 (58.2%) were women and 430,431 (41.8%) were men. Findings from the SERIOUS-PE study will help address important knowledge gaps related to sex differences in presentation and risk factors, treatment patterns, and outcomes of older adults with PE. The results may guide changes in prognostic prediction rules based on sex-specific findings, identify sex-based disparities in care delivery that should be addressed by quality improvement, or uncover potential differences in response to available therapies that warrant testing in dedicated randomized trials. • Sex and age may impact pulmonary embolism (PE) presentation and outcomes. • Sex differences in PE presentation, treatment patterns, and outcomes remain unknown. • The SERIOUS-PE study will use two large data sources to answer these knowledge gaps. • Treatment disparities need quality improvement initiatives to mitigate disparities. • Adjusted analyses of outcomes will indicate whether sex-specific RCTs are needed. [ABSTRACT FROM AUTHOR]

There are several prognostic models to estimate the risk of mortality after surgery for active infective endocarditis (IE). However, these models incorporate different predictors and their performance is uncertain. We systematically reviewed and critically appraised all available prediction models of postoperative mortality in patients undergoing surgery for IE, and aggregated them into a meta-model. We searched Medline and EMBASE databases from inception to June 2020. We included studies that developed or updated a prognostic model of postoperative mortality in patient with IE. We assessed the risk of bias of the models using PROBAST (Prediction model Risk Of Bias ASsessment Tool) and we aggregated them into an aggregate meta-model based on stacked regressions and optimized it for a nationwide registry of IE patients. The meta-model performance was assessed using bootstrap validation methods and adjusted for optimism. We identified 11 prognostic models for postoperative mortality. Eight models had a high risk of bias. The meta-model included weighted predictors from the remaining three models (EndoSCORE, specific ES-I and specific ES-II), which were not rated as high risk of bias and provided full model equations. Additionally, two variables (age and infectious agent) that had been modelled differently across studies, were estimated based on the nationwide registry. The performance of the meta-model was better than the original three models, with the corresponding performance measures: C-statistics 0.79 (95% CI 0.76–0.82), calibration slope 0.98 (95% CI 0.86–1.13) and calibration-in-the-large –0.05 (95% CI –0.20 to 0.11). The meta-model outperformed published models and showed a robust predictive capacity for predicting the individualized risk of postoperative mortality in patients with IE. PROSPERO (registration number CRD42020192602). [ABSTRACT FROM AUTHOR]

• Sepsis was more common in males than females • Males with sepsis presented higher disease severity than females • Sex did not affect mortality in patients with sepsis and admitted to intensive care units Men have been considered to have a higher incidence of infectious diseases, with controversy over the possibility that sex could influence the prognosis of the infection. This study aimed to explore this assumption in patients admitted to the intensive care unit (ICU) with septic bacteremia. A retrospective analysis (2006-2017) of septic patients with microbiologically confirmed bacteremia (n=440) was performed. Risk of ICU and in-hospital mortality in males versus females was compared by univariate analysis and a propensity score analysis integrating their clinical characteristics. Sepsis more frequently occurred in males (80.2% vs 76.1%) as well as in-hospital (48.0% vs 41.3%) and ICU (39.9% vs 36.5%) mortality. Univariate analyses showed that males had a higher Charlson comorbidity index and worse McCabe prognostic score. However, the propensity score in 296 matched patients demonstrated that females had higher risk of both ICU (OR 1.39; 95% CI 0.89-2.19) and in-hospital mortality (OR 1.18; 95% CI 0.77-1.83), but without statistical significance. Males with sepsis had worse clinical characteristics when admitted to the ICU, but sex had no influence on mortality. These data contribute to helping reduce the sex-dependent gap present in healthcare provision. [ABSTRACT FROM AUTHOR]

To address the association between psychiatric disorders and short-term outcomes after acute symptomatic pulmonary embolism (PE). We identified adults with PE enrolled in the RIETE registry between December 1, 2013, and January 31, 2019. Using multinomial regression, we assessed the association between a history of psychiatric disorders and the outcomes of all-cause mortality, PE-related mortality, and venous thromboembolism recurrence and bleeding rates through 30 days after initiation of treatment. We also examined the impact of depression on all-cause and PE-specific mortality. Among 13,120 patients diagnosed with acute PE, 16.1% (2115) had psychiatric disorders and 4.2% died within the first 30-days of follow-up. Patients with psychiatric disorders had increased odds for all-cause (adjusted odds ratio [ OR ] 1.50; 95% CI, 1.21 to 1.86; P < 0.001) and PE-related mortality (adjusted OR 1.64; 95% CI, 1.09 to 2.48; P = 0.02) compared to those without psychiatric disorders. Multinomial logistic regression showed a non-significant trend toward lower risk of recurrences for patients with psychiatric disorders (adjusted OR 0.49; 95% CI, 0.21 to 1.15; P = 0.10). Psychiatric disorders were not significantly associated with increased odds for major bleeds during follow-up (adjusted OR 1.09; 95% CI, 0.85 to 1.40; P = 0.49). Results were consistent in a sensitivity analysis that only considered patients with a diagnosis of depression. In patients with acute PE, history of psychiatric disorders might predict all-cause and PE-related death in the ensuing month after diagnosis. • If psychiatric disorders are associated with prognosis after PE, interventions might be worth testing to mitigate outcomes. • In patients with PE, history of psychiatric disorders is a predictor of death in the ensuing month after diagnosis. • Depression was associated with a 1.4-fold increase in the odds of 30-day all-cause mortality. [ABSTRACT FROM AUTHOR]

Background: Nontraumatic headache is a frequent complaint in the emergency department (ED). Cranial computed tomography (CT) is a widely available test for the diagnostic work-up, despite the risk of exposure to ionizing radiation.Objectives: We sought to develop and evaluate a cranial CT request computerized decision support system (CDSS) for adults with their first presentation of unusual severe nontraumatic headache in the ED.Methods: Electronic database searches identified clinical decision and prediction rules and studies delineating risk factors in nontraumatic headache. A long list of risk factors extracted from these articles was reduced by a 30-member multidisciplinary expert panel (radiologists, emergency physicians, methodologists), using a 90% agreement threshold. This shortlist was used to develop the algorithm for the cranial CT request CDSS, which was implemented in March 2016. Impact evaluation compared CT scan frequency and diagnostic yield of pathologic findings before (March-August 2015) and after (March-August 2016) implementation.Results: From the 10 selected studies, 10 risk factors were shortlisted to activate a request for cranial CT. Before implementation, 377 cranial CTs were ordered (15.3% of 2469 CT scans) compared with 244 after (9.5% of 2561 CT scans; pre-post difference 5.74%; 95% confidence interval [CI] 3.92-7.56%; p < 0.001), corresponding to a 37.6% relative reduction in the test ordering rate (95% CI 25.7-49.5%; p < 0.001). Despite the reduction in cranial CT scans, we did not observe an increase in pathological findings after introducing the decision support system (70 cases before [18.5%] vs. 35 cases after [14.3%]; pre-post difference -4.0% [95% CI -10.0 to 1.6%]; p = 0.170).Conclusion: In nontraumatic headache among adults seen in the ED, CDSS decreased the cranial CT request rate but the diagnostic yield did not improve. [ABSTRACT FROM AUTHOR]

Background: Despite advances in hospital management in recent years, it is not clear whether mortality after acute pulmonary embolism (PE) has decreased over time.Objectives: This study describes the trends in the management and outcomes of acute symptomatic PE.Methods: We identified adults with acute PE enrolled in the registry between 2001 and 2013. We assessed temporal trends in length of hospital stay and use of pharmacological and interventional therapies. Using multivariable regression, we examined temporal trends in risk-adjusted rates of all-cause and PE-related death to 30 days after diagnosis.Results: Among 23,858 patients with PE, mean length of stay decreased from 13.6 to 9.3 days over time (32% relative reduction, p < 0.001). For initial treatment, use of low-molecular-weight heparin increased from 77% to 84%, whereas the use of unfractionated heparin decreased from 22% to 8.4% (p < 0.001 for trend for all comparisons). Thrombolytic therapy use increased from 0.7% to 1.0% (p = 0.07 for trend) and surgical embolectomy use doubled from 0.3% to 0.6% (p < 0.01 for trend). Risk-adjusted rates of all-cause mortality decreased from 6.6% in the first period (2001 to 2005) to 4.9% in the last period (2010 to 2013) (p = 0.02 for trend). Rates of PE-related mortality decreased over time, with a risk-adjusted rate of 3.3% in 2001 to 2005 and 1.8% in 2010 to 2013 (p < 0.01 for trend).Conclusions: In a large international registry of patients with PE, improvements in length of stay and changes in the initial treatment were accompanied by a reduction in short-term all-cause and PE-specific mortality. [ABSTRACT FROM AUTHOR]

Study Objective: To develop individualized dynamic predictions for the occurrence of acute kidney injury (AKI) during the first postoperative week after cardiac surgery.Design: Observational retrospective cohort study.Setting: Single university teaching hospital in Madrid, Spain.Patients: 3960 cases of major cardiac surgery performed from January 2002 to December 2013.Measurements: Baseline demographic and clinical characteristics, intraoperative risk factors, and repeated postoperative estimated glomerular filtration rates (eGFR). The primary outcome was AKI during the first postoperative week (stage 1 or higher of the Acute Kidney Injury Network). The dataset was split in two random samples (exploratory and validation). By combining time-to-event outcomes (AKI), and longitudinal data (repeated postoperative eGFR), we developed two different joint models for patients with normal and high baseline levels of serum creatinine (sCr).Main Results: AKI occurred in 1105 patients (31%, 95% confidence interval [CI] 29.5-32.5) in the exploratory sample and 128 (32.2%, 95% CI 27.6-36.8) in the validation sample. For high baseline sCr patients, the risk of an AKI event was associated with the eGFR trajectory (hazard ratio [HR] 0.91, 95% CI 0.90-0.92), as well as with age, and cardiopulmonary bypass time. The normal baseline sCr model incorporated the same covariates and intraoperative transfusion. In this second model, the risk of an AKI event was associated with both the eGFR trajectory (HR 0.91, 95% CI 0.91-0.92, for the current value of eGFR), and with its slope at that point (HR 0.96, 95% CI 0.94-0.99). So AKI risk decreased when the eGFR values increased, in accordance with the speed of this rise. Internal validation showed good discrimination and calibration of both joint models. The AUCs were always higher than 0.7.Conclusions: The joint models obtained combining both patient risk factors and postoperative eGFR values, are useful to predict individualized risk of cardiac surgery-associated AKI. Predictions can be updated as new information is gathered. [ABSTRACT FROM AUTHOR]

Background context In the context of shared decision-making, a valid estimation of the probability that a given patient will improve after a specific treatment is valuable. Purpose To develop models that predict the improvement of spinal pain, referred pain, and disability in patients with subacute or chronic neck or low back pain undergoing a conservative treatment. Study design and setting Analysis of data from a prospective registry in routine practice. Patient sample All patients who had been discharged after receiving a conservative treatment within the Spanish National Health Service (SNHS) (n=8,778). Outcome measures Spinal pain, referred pain, and disability were assessed before the conservative treatment and at discharge by the use of previously validated methods. Methods Improvement in spinal pain, referred pain, and disability was defined as a reduction in score greater than the minimal clinically important change. A predictive model that included demographic, clinical, and work-related variables was developed for each outcome using multivariate logistic regression. Missing data were addressed using multiple imputation. Discrimination and calibration were assessed for each model. The models were validated by bootstrap, and nomograms were developed. Results The following variables showed a predictive value in the three models: baseline scores for pain and disability, pain duration, having undergone X-ray, having undergone spine surgery, and receiving financial assistance for neck or low back pain. Discrimination of the three models ranged from slight to moderate, and calibration was good. Conclusions A registry in routine practice can be used to develop models that estimate the probability of improvement for each individual patient undergoing a specific form of treatment. Generalizing this approach to other treatments can be valuable for shared decision making. [ABSTRACT FROM AUTHOR]

Abstract: Background: A clinically isolated syndrome (CIS) may be the initial presentation of multiple sclerosis (MS). However, some CIS never develop MS. The identification of patients at risk of MS conversion is crucial as early treatment may improve their outcome. Free kappa chains (FKC) are increased in cerebrospinal fluid (CSF) of MS patients. We studied the accuracy of CSF FKC level measurement, using a new nephelometric test, to predict conversion of CIS patients to MS. Methods: We calculated linearity and inter-assay variability of the FKC test for CSF values and quantified this protein in CSF from 25 patients with non-inflammatory neurological diseases (NIND) and 78 consecutive CIS patients. We assessed whether high CSF FKC levels associate with CIS conversion to clinically definite MS, defined as the onset of new relapses during follow-up. Results: Between 0.1 and 5mg/l the FKC test showed linearity of 0.98 and inter-assay correlation coefficient of =0.99. A cut-off value of 0.53mg/l (mean+2SD of NIND group CSF FKC values) was calculated. CIS patients with CSF FKC above this value showed earlier conversion to MS in univariate and multivariate Cox analysis (HR=6.41; 95% CI=1.88–21.78, p=0.003). Conclusion: High CSF FKC levels accurately predict CIS patient conversion to MS. [Copyright &y& Elsevier]

Abstract: Background context: Conflicting reports exist regarding the prevalence of Modic changes among low back pain (LBP) patients and factors associated with their existence. Purpose: To assess the prevalence of Modic changes and other findings on lumbar magnetic resonance imaging (MRI) among Spanish adult chronic LBP patients and the patient characteristics and radiological findings associated with Modic changes. Study design: A cross-sectional imaging study among chronic LBP patients. Patient sample: Four hundred eighty-seven patients (263 women and 224 men) undergoing lumbar spine MRI examination for chronic LBP. Outcome measures: Gender, age, body mass index (BMI), lifetime smoking exposure, degree of physical activity, and image features (disc degeneration, type and extension of Modic changes, disc contour, annular tears, spinal stenosis, and spondylolisthesis). Methods: Ten radiologists from six hospitals across six cities in Spain consecutively recruited adult patients in whom lumbar MRI had been prescribed for LBP lasting ≥3 months. Patients'' characteristics and imaging findings were assessed through previously validated instruments. A multivariate logistic regression model was developed to assess the features associated with Modic changes. Results: Modic changes were found in 81% of the patients. The most common was Type II (51.3%), affecting only the end plate. Variables associated with Type I changes were disc contour abnormalities, spondylolisthesis, and disc degeneration. The same variables were associated with a higher risk of Type II or any type of Modic changes, as well as being male, and having a higher BMI. Conclusions: Modic changes are found in 81% (95% confidence interval, 77–85) of adult Spanish patients in whom an MRI is prescribed for chronic LBP. Modic changes are more likely to be found in males with a high BMI, who also show disc contour abnormalities, spondylolisthesis, or disc degeneration. [Copyright &y& Elsevier]

General and specific severity scores for patients with acute kidney injury have significant limitations due in part to the diversity of methods that have been used. Here we prospectively validated five general (APACHE II, SAPS II, SOFA, LODS, and OSF) and three specific (SHARF, Liaño, and Mehta) scoring systems in 366 critically ill patients who developed acute kidney injury in the intensive care unit. Sequential scores in each system were determined on the day that acute kidney injury was diagnosed, on the day when acute kidney injury–specific score criteria were achieved, and on the day of initial nephrology consultation. Acute kidney injury, defined as an increase of 50% or more in the baseline serum creatinine, was mainly due to sepsis, and had an incidence of 19% and an overall 68% mortality. A progressive improvement in score performance was found. On the day of initial nephrology consultation, most scores showed a good performance and two indices (SAPS II and SHARF) achieved an area under the receiver operating characteristic curve above 0.80. Calibration was good on all three defining days, except for OSF when score criteria were achieved, and Mehta at the time of nephrology consultation. Our study shows that early and sequential evaluation is a better approach for prognostic scoring in critically ill patients who develop acute kidney injury.Kidney International (2009) 75, 982–986; doi:10.1038/ki.2009.3; published online 11 February 2009 [ABSTRACT FROM AUTHOR]

Abstract: Candidemia is an important problem in pediatrics. In our hospital, highest candidemia rates were documented among children with congenital heart disease (CHD). A series was conducted to describe the clinical and mortality features of candidemia in these patients. Fifty-two cases (1988–2000) included very young infants (median age, 2 months) who received long-term antibiotic treatment (median, 20.5 days). Candida parapsilosis predominated (54%). Endovascular infections occurred in 11.5%. In-hospital mortality was 39% and related mortality 14%. Maintenance of catheter (odds ratio [OR], 6.0; 95% confidence interval [CI], 1.0–37.2; P = .05) and severity of patients as measured with the Pediatric Risk Score of Mortality I (OR, 1.1, 95% CI, 1.0–1.3; P = .05) were independently associated with mortality. In summary, candidemia in children with CHD is diagnosed to very young infants with prolonged antibiotic therapy. Mortality is high but, in most cases, is not related to candidemia. Optimal management may include exclusion of endocarditis, early antifungal treatment, and catheter removal. [Copyright &y& Elsevier]