Incidence Of Hospitalization Research Articles

ANÁLISE DO PERFIL EPIDEMIOLÓGICO DAS INTERNAÇÕES E ÓBITOS POR LEUCEMIA NO BRASIL NA FAIXA ETÁRIA PEDIÁTRICA: UMA ANÁLISE DO ANO DE 2017 ATÉ A ATUALIDADE.

The present study is based on the epidemiological analysis of leukemia, the most common childhood cancer, which has a high prevalence and incidence rate in the pediatric population, as well as a significant impact on mortality in this age group. The objective of this research is to analyze the national profile of hospital admissions and deaths due to leukemia from 2017 to the present. For this purpose, secondary data from the Hospital Information System (SIH) and the Mortality Information System (SIM), collected from the DATASUS digital platform, were used. The selected variables included age groups under 1 to 19 years, male and female gender, and racial/ethnic categories of white, mixed-race, black, Asian, and indigenous populations. The results revealed a higher prevalence and incidence of hospitalizations for leukemia over the years, particularly in the Southeast, Northeast, and South regions, with a significant concentration in the 1 to 9-year age group, among males, and in the mixed-race and white populations. Regarding the number of deaths, substantial data were observed in the Southeast, Northeast, and North regions, predominantly in individuals aged 10 to 19 years, among males, and in the white and mixed-race populations. Given the above, the urgency of addressing leukemia in the pediatric population in Brazil is evident, as it impacts patients’ quality of life, the vital statistics of this population, and the healthcare system. The data highlight the need for public health actions to reduce regional disparities in specialized cancer care, late diagnoses, and ineffective and limited treatments.

Threshold Modeling for Antibiotic Stewardship in Oman.

Antimicrobial stewardship supports rational antibiotic use. However, balancing access to antibiotic treatment while controlling resistance is challenging. This research used a threshold logistic modelling approach to identify targets for antibiotic usage associated with carbapenem-resistant Acinetobacter baumannii (CRAb), carbapenem-resistant Klebsiella pneumonia (CRKP), and extended-spectrum β-lactamases- producing Escherichia coli (ESBL-producing E. coli) incidence in hospitals. This study utilises an ecological population-level design. Monthly pathogen cases and antibiotic use were retrospectively determined for inpatients between January 2015 and December 2023. The hospital pharmacy and microbiology information systems were used to obtain this data. Thresholds were identified by applying nonlinear modelling and logistic regression. Incidence rates of 0.199, 0.175, and 0.146 cases/100 occupied bed-days (OBD) for CRAb, CRKP, and ESBL-producing E. coli, respectively, were determined as the cutoff values for high (critical) incidence rates. Thresholds for aminoglycosides (0.59 defined daily dose (DDD)/100 OBD), carbapenems (6.31 DDD/100 OBD), piperacillin-tazobactam (3.71 DDD/100 OBD), third-generation cephalosporins (3.71 DDD/100 OBD), and fluoroquinolones (1.91 DDD/100 OBD), were identified. Exceeding these thresholds would accelerate the gram-negative pathogens' incidence rate above the critical incidence levels. Employing the threshold logistic approach enabled near real-time performance monitoring feedback, risk scores and alert signals for when the incidence of the selected pathogens are entering critical levels. Threshold logistic models can help inform and implement effective antimicrobial stewardship interventions to manage resistance within hospital settings.

Abstract 4134974: SGLT2 Inhibitors Following Acute Myocardial Infarction: A Systematic Review and Meta-Analysis

Background: Sodium-glucose cotransporter 2 inhibitors (SGLT2i) have demonstrated cardiovascular benefits in various settings. However, their impact after myocardial infarction (MI) in patients without prior heart failure remains unclear. Therefore, we conducted a meta-analysis comparing SGLT2i to placebo in post-MI patients. Methods: We systematically searched Pubmed, Embase, and Cochrane Central for randomized controlled trials (RCTs) comparing SGLT2i to placebo in post-MI patients. We calculated the Risk Ratio (RR) for binary outcomes and 95% confidence intervals (CI). Statistical analysis was performed using Review Manager 5.4. A random-effects model was used for all outcomes. Heterogeneity was examined with I2 statistics. Results: We included 3 RCTs comprising 11,065 patients in this meta-analysis, where 79.5% were male with a mean age of 61.9 years old. Two studies evaluated Empaglifozin and one Dapagliflozin. There was no statistically significant difference between groups in all-cause mortality (RR 1.05; 95% CI 0.78-1.41; p= 0.76; Figure 1A) and cardiovascular mortality (RR 1.04; 95% CI 0.84-1.29; p= 0.73; Figure 1B). There was a statistically significant reduction in the incidence of heart failure hospitalization in the SGLT2i group (RR 0.73; 95% CI 0.61-0.88; p< 0.01; Figure 1C). Conclusion: Our systematic review and meta-analysis found that SGLT2i significantly reduced the incidence of heart failure hospitalization in patients following MI, without significantly affecting all-cause or cardiovascular mortality.

Abstract 4113486: Cardiovascular Benefits of Sotagliflozin in Diabetic Populations: A Meta-Analysis

Background: Sotagliflozin, an inhibitor of both SGLT1 and SGLT2, is under investigation for potential cardioprotective effects in diabetic patients. Aims: This study assesses the efficacy and cardiovascular benefits of sotagliflozin in patients with type 1 or type 2 diabetes at high cardiovascular risk or with diagnosed heart failure. Methods: We systematically searched digital databases including ClinicalTrials.gov, PubMed, Google Scholar, Cochrane, Medline, and Embase, using a PICOS-based strategy and the PRISMA framework for data reporting. Randomized controlled trials comparing sotagliflozin against placebo over a minimum duration of eight weeks were analyzed using Review Manager (RevMan) 5.4.1. Results: Our meta-analysis included 7 studies with 16,315 participants with all studies comparing either 200 or 400 mg sotagliflozin to placebo. The meta analaysis revealed significant improvements in reduction the total number of cardiovascular deaths [OR= 0.70 (95% CI (0.51- 0.95)), p = 0.02]; reduction in Non-fatal MI [OR=0.76 (95% CI (0.70- 0.84)), p < 0.00001]; reduction in the incidence of hospitalizations due to HF [OR=0.54 (95% CI (0.44, 0.66)), p < 0.00001]; reduction In urgent hospitalizations [OR=0.66 (95% CI (0.53, 0.83)), p=0.0004]; improvement in LVEF>50% [ OR= 0.41 (95%CI (0.34, 0.51)), p<0.0001] and reduction in systolic blood pressure mean reduction of -0.81 (95% CI (1.36, -0.25)), p=0.005]. However there was no statistically significant reduction in all cause mortality [0.73 (95% CI (0.42, 1.26)), p=0.26] . Conclusion: Sotagliflozin significantly reduces the incidence of cardiovascular deaths, adverse events, and hospitalizations in diabetic patients at high risk of cardiovascular complications.

Abstract 4132291: Assessing the Efficacy of Preventive Percutaneous Coronary Intervention vs Optimal Medical Therapy for the Treatment of Vulnerable Plaque: A Meta-analysis

Introduction: Rupture and thrombosis of lipid-rich atherosclerotic plaques (vulnerable plaques) contributes to majority of acute coronary syndrome (ACS). Current guidelines recommend optimal medical therapy (OMT) for stabilization of vulnerable plaques. Recent evidence of preventive percutaneous intervention (PCI) as a targeted treatment shows improvement in outcomes in these patients. Hypothesis/Goals/Aims: We aim to evaluate the efficacy of preventive percutaneous coronary intervention (PCI) compared to optimal medical therapy (OMT) for treatment of non-vulnerable plaque within five years of follow up from available selected randomized controlled trials (RCTs). Methods: PubMed, Cochrane, OVID, and NIH Clinical Trials were searched for RCTs evaluating preventive PCI compared to standard of care medical therapy. All trials reported primary common endpoints as death from cardiac cause and myocardial infarction (MI). Secondary outcomes included all-cause mortality, any revascularization, hospitalization for unstable and progressive angina, and composite death (any cause, MI, or any revascularization). Sub analyses for secondary outcomes were included if measured by RCT. A fixed effect model with Mantel-Haenszel statistical method was used to calculate risk ratios, Z scores, and a 95% confidence interval. Results: Ten RCTs (n=15955 patients) were included. Preventive PCI of vulnerable plaques revealed a significant benefit in lowering incidence of MI (RR: 0.86 [0.77, 0.86], p=0.01) and death from cardiac cause (RR: 0.73 [0.62, 0.86], p=0.004). Similarly, patients undergoing preventive PCI had a lower incidence of hospitalization for unstable or progressive angina (RR: 0.75 [0.62, 0.91], p<0.0001) and composite death (RR: 0.55 [0.46, 0.67], p<0.001). No difference was noted in all-cause mortality. Incidence of revascularization had a significant benefit with OMT therapy compared to preventive PCI (RR: 1.84 [1.75, 1.94], p<0.0001). Conclusion: Preventive PCI in vulnerable plaque demonstrates cardiovascular benefit as a result from lower incidence of MI, death from cardiac cause, composite death and fewer hospitalization for unstable or progressive angina.

Risk factors and predictive model development for high blood loss in minimally invasive distal pancreatectomy: a retrospective cohort study.

High blood loss is an adverse event related to increased morbidity and poorer outcomes in pancreatic surgery patients. The aim of this study was to identify risk factors and establish a predictive model for high perioperative blood loss (HPBL) in minimally invasive distal pancreatectomy (MIDP). We collected data from 353 patients who underwent MIDP at a university affiliated tertiary hospital between January 2016 and October 2023. Perioperative blood loss was calculated based on pre- and postoperative hemoglobin concentrations according to a combination of the formulas provided by Nadler and Gross. Multivariate logistic regression analyses were performed for the training cohort to identify the clinical factors independently associated with perioperative blood loss (PBL). A predictive nomogram based on these factors was established and validated. Weight, imaging findings, serum albumin concentration, MIDP experience, spleen treatment, and operation time were independent predictors for HPBL. The established model for predicting HPBL showed that the area under the curve (AUC) was 0.799 (95% CI = 0.746-0.853) and 0.852 (95% CI = 0.760-0.943) for the training cohort and validation cohort, respectively. When utilized to predict blood transfusion, the AUC was 0.778 (95% CI = 0.691-0.865) in the training cohort and 0.818 (95% CI = 0.681-0.955) in the validation cohort. Patients with a high predicted risk had significantly higher incidences of postoperative pancreatic fistula, intra-abdominal infection, and longer hospital stays than patients with a low risk. We established and validated a model for predicting HPBL in MIDP patients. This novel model may have future utility when generating surgical strategies.

Efficacy of Intravenous Ferric Carboxymaltose in Heart Failure Patients with Iron Deficiency Anemia: A Meta-analysis of 6271 Patients.

Iron deficiency is prevalent among heart failure patients and is associated with worse clinical outcomes, including decreased quality of life and functional capacity. This condition often results in a higher incidence of hospitalization and mortality. Iron supplementation, particularly with intravenous ferric carboxymaltose (FCM), has shown potential benefits as an adjunct therapy in heart failure management. This study aims to evaluate the efficacy of FCM in the treatment of patients with heart failure and iron deficiency anemia, with a focus on its impact on mortality and hospitalization rates. A comprehensive search was conducted in PubMed, Web of Science, and Scopus databases from their inception until 1st December 2023. Meta-analysis was performed using RevMan 5.4, employing a random-model effect. The results were reported as risk ratios (RRs), standard mean differences (SMDs), and 95 % confidence intervals (CIs). The meta-analysis included 13 studies with a total of 6271 patients. Ferric carboxymaltose administration resulted in a significant improvement in the 6-minute walk distance (SMD: 1.45; 95 % CI: 0.55, 2.36; p = 0.002), quality of life, as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) (SMD: 1.49; 95 % CI: 0.87, 2.11; p < 0.00001), the rate of first hospitalization for heart failure or cardiovascular death (RR: 0.91; 95 % CI: 0.84, 0.98; p = 0.02). However, FCM did not show a significant impact on the risk of cardiovascular death (RR: 0.90; 95 % CI: 0.77, 1.05; p = 0.17), the need for intervention due to worsening heart failure (RR: 0.41; 95 % CI: 0.04, 4.51; p = 0.47), or all-cause mortality rates (RR: 0.89; 95 % CI: 0.69, 1.16; p = 0.28). While FCM treatment in patients with heart failure and iron deficiency anemia significantly improves functional capacity and quality of life, it has no notable effect on mortality rates or the likelihood of hospitalization. These findings highlight the need for further research to explore comprehensive treatment strategies that address both the symptomatic and survival aspects of heart failure management in this patient population.

Diuretics and mortality reduction in incident dialysis patients: a two-year observational study

Fluid overload predicts morbidity and mortality in dialysis patients. Diuretics can reduce fluid overload, but their effects on morbi-mortality following inception remain ill-defined. To determine whether diuretics reduce mortality and hospitalization rates in incident dialysis patients in the first 2 years after inception. Adult patients starting dialysis between 2009 and 2015 in the REIN registry were matched with the SNDS database and divided into four subgroups according to loop diuretics exposure: < 5%, 5–50%, 50–80% or > 80% over the observation period of each patient. The incidence of hospitalization was described based on the primary diagnoses of the discharge summaries and codes. In this study, which included 67,736 patients, 53,829 (79.5%) who had varying degrees of diuretic exposure exhibited a significantly lower mortality rate at 2 years compared to those without diuretic exposure (24.8% [95% CI 24.4–25.2], vs 37.5% [95% CI 36.7–38.3] respectively). However, the duration of diuretic exposure significantly impacted outcomes. The all-cause mortality rate at two years was highest in the group with ≥ 80% exposure (68.2% [95% CI 67.3–69.1]), followed by those with 50–80% exposure (15.7% [95% CI 15.0–16.4]), and those with 5–50% exposure (6.6% [95% CI 6.3–7.0]). An inverse probability weighting (IPW) propensity score analysis supported these findings. Stratified analyses showed consistent results regardless of a history of congestive heart failure and were similar for both hemodialysis and peritoneal dialysis patients. Additionally, the number of hospitalizations and length of stay were generally higher in the group with the longest exposure to loop diuretics. Diuretic exposure was generally associated with a lower mortality rate in dialysis patients. However, prolonged exposure (≥ 80%) was linked to an increased risk of mortality and hospitalization. This prolonged exposure may indicate residual diuresis at the cost of chronic fluid overload.

Treatment of Spontaneous Subarachnoid Hemorrhage: A 20‐Year National Inpatient Sample Review

BACKGROUND Aneurysmal subarachnoid hemorrhage (aSAH) is a major source of morbidity and mortality, and its management has undergone foundational changes over thepast 2 decades. We reviewed the National Inpatient Sample to outline the changes in severity of illness, surgical management, and patient outcomes over time. METHODS A retrospective cohort of admissions for spontaneous SAH in the National Inpatient Sample from 2001 to 2020 was reviewed, including those who underwent microsurgical or endovascular surgery to secure a ruptured aneurysm. National incidence was calculated, and multivariable regression was used to identify changes in incidence and outcome through time, segmented by epoch. RESULTS Review of the National Inpatient Sample identified 448 655 patients with SAH, of whom 181 590 underwent surgical aneurysm treatment. The incidence of spontaneous SAH fell −0.097 per 100 000 person‐years each year (95%CI, −0.144 to −0.049). Among patients surgically treated for aneurysmal SAH, the proportion of patients &lt;50 years old fell from 40% to 30% between first and final epochs, and the proportion of those in the lowest stroke scale category, roughly equivalent to Hunt and Hess grade 1 or 2, fell from 66% to 45%. The proportion treated by microsurgery fell from 70% to 23% in favor of endovascular surgery. Hospital mortality among these treated cases was stable at 13% throughout the study period despite increasing illness severity indices. After adjustment, there was a 42% reduction of odds of hospital mortality in the final epoch compared with the first. CONCLUSION The incidence of hospitalization for spontaneous SAH fell between 2001 and 2020. Patients undergoing surgery to secure an aneurysm were more severely ill through time yet experienced a stable hospital mortality rate.

COVID-19 vaccination-related delayed adverse events among people with rheumatoid arthritis: results from the international COVAD survey.

This study aimed to assess COVID-19 vaccination-related AEs in patients with rheumatoid arthritis (RA), in the COVID-19 Vaccination in Autoimmune Diseases (COVAD)-2study. An online international cross-sectional survey captured self-reported data on COVID-19 vaccination-related adverse events (AEs) in people with RA, autoimmune diseases (AIDs; rheumatic [r] and non-rheumatic [nr]) and healthy controls (HCs). The survey was circulated by the COVAD study group, comprising 157 collaborators across 106 countries, from February to June 2022. Delayed AEs among RA were compared with other rAIDs, nrAIDs and HCs using multivariable binary regression. A total of 7203 participants were included (1423 [19.7%] RA, 2620 [36.4%] rAIDs, 426 [5.9%] nrAIDs, 2734 [38%] HCs), with 75% female. Compared to HCs, individuals with RA reported higher overall major AEs [OR 1.3 (1.0-1.7)], and an increased number of several minor AEs. Compared to nrAIDs, people with RA had several increased reported minor AEs including myalgia and joint pain. People with active RA had increased major AEs [OR 1.8 (1.1-3.0)] and hospitalisation [OR 4.1 (1.3 - 13.3)] compared to inactive RA. RA patients without autoimmune comorbidities had significantly fewer major and minor AEs than those with other rAIDs. A decreased incidence of hospitalisation was seen in patients taking methotrexate or TNF inhibitors compared to patients not taking these medications. COVID-19 vaccination is associated with minimal to no risks of delayed AEs in patients with RA compared to HCs, and fewer compared to other rAIDs. Active RA and presence of co-existing rAIDs were associated with an increased risk of delayed AEs.

Clinical profile of herpes zoster-related hospitalizations and complications: A French population-based database study

To estimate the incidence of hospitalization with a diagnosis of herpes zoster (HZ) and post-herpetic neuralgia (PHN) in France between 2013 and 2020, overall and stratified by age-group and immune status. Retrospective observational, database study, using the French hospital discharge database, which includes private and public data for all day-care and inpatient stays. Adults aged ≥18 years, hospitalized between January 1, 2013, and December 31, 2020, with a diagnosis of HZ or PHN were included. Overall, 62 077 adults had a first hospitalization with a diagnosis of HZ or PHN during the observation period. HZ and/or PHN incidence ranged between 14.6 and 16.3 hospitalizations/100 000 persons and was highest in people aged ≥80 years (97.6 hospitalizations/100 000 persons). The immunocompromised (IC) population accounted for 22% of the overall study population. IC patients had longer lengths of stay for HZ per episode compared with non-IC patients (15.5 ± 19.4 days vs 12.2 ± 13.5 days) and higher in-patient mortality (8% vs 4%). Average annual hospitalization costs per patient were higher in the IC vs non-IC population (€8018 vs €5603). Older age increases hospitalization rates up to 6-fold and IC status increases in-patient mortality up to two-fold.

The Burden of Seasonal Influenza and Its Potential Complications Among Older Japanese Adults: A Real-World Database Study.

Seasonal influenza may lead to severe complications, including respiratory and cardiovascular disease, that result in considerable healthcare resource utilization (HCRU) and mortality, particularly in older individuals. This real-world study assessed the burden of influenza and its potential complications in older Japanese adults. This retrospective claims database analysis (April 2015 to June 2019) included insured individuals aged ≥ 60 years at the start of four consecutive influenza seasons in Japan (October 1 to April 30). The primary endpoint was the incidence of influenza-related emergency room (ER) and outpatient visits, the incidence of hospitalizations, the probability of 30-day inpatient mortality, and 60-day medical costs of influenza or its potential complications. Of 8,974,708 individuals (43.2% male, mean ± standard deviation age 73.8 ± 8.9 years), 370,430 (4.13%) were diagnosed with influenza. Overall, 17.18 (95% confidence interval [CI] 16.32-18.04) and 3893.53 (3880.87-3906.19) per 100,000 individuals had influenza-related ER and outpatient visits, respectively, and 181.50 (178.71-184.28) per 100,000 individuals were hospitalized for influenza. The incidence of influenza-related ER visits and hospitalizations for influenza or potential complications and the probability of 30-day inpatient mortality increased with age. Seasonal influenza and its potential complications represent a substantial burden that increases with age in Japanese individuals.

Early mobilization and its impact on recovery in ICU patients with severe COVID-19: A randomized controlled trial

Introduction. The COVID-19 pandemic has severely impacted critically ill patients, often leading to prolonged immobilization in intensive care units (ICUs), which can result in ICU-acquired weakness (ICUAW) and delayed recovery. Early mobilization has emerged as a promising intervention to counter these effects by promoting faster recovery and reducing complications. This study aims to investigate the effects of early mobilization on physical function, muscle strength, and recovery outcomes in ICU patients with severe COVID-19. Methods. This randomized controlled trial (RCT) included 100 ICU patients (50 in the early mobilization group, 50 in the control group) with severe COVID-19. Early mobilization began within 48 to 72 hours of ICU admission and followed a stepwise progression through four mobility levels. Outcome measures included the Physical Function ICU Test (PFIT), Medical Research Council (MRC) sum score, incidence of delirium, ICU and hospital stay length, ventilator-free days, mortality, and readmission rates. Statistical analysis used intention-to-treat methods, with continuous and categorical variables tested accordingly. Results. The early mobilization group had a significantly shorter time to first mobilization (2.3 days vs. 5.8 days, p &lt; 0.001), higher PFIT scores at ICU discharge (25.4 vs. 18.2, p &lt; 0.001), and improved MRC sum scores (48.6 vs. 35.4, p &lt; 0.001) compared to the control group. The incidence of delirium was significantly lower in the early mobilization group (20% vs. 38%, p = 0.03). ICU and hospital stays were shorter in the early mobilization group (10.4 vs. 14.2 days, p &lt; 0.001; 18.5 vs. 24.1 days, p &lt; 0.001). The early mobilization group had more ventilator-free days (20.3 vs. 14.7, p &lt; 0.001). Mortality and readmission rates were similar between groups. Conclusion. Early mobilization significantly improves functional outcomes, reduces ICU and hospital length of stay, and lowers the incidence of delirium in ICU patients with severe COVID-19. These findings support incorporating early mobilization as standard practice in ICUs to enhance recovery outcomes.

Large-Scale Pharmacogenomics Analysis of Patients With Cancer Within the 100,000 Genomes Project Combining Whole-Genome Sequencing and Medical Records to Inform Clinical Practice.

As part of the 100,000 Genomes Project, we set out to assess the potential viability and clinical impact of reporting genetic variants associated with drug-induced toxicity for patients with cancer recruited for whole-genome sequencing (WGS) as part of a genomic medicine service. Germline WGS from 76,805 participants was analyzed for pharmacogenetic (PGx) variants in four genes (DPYD, NUDT15, TPMT, UGT1A1) associated with toxicity induced by five drugs used in cancer treatment (capecitabine, fluorouracil, mercaptopurine, thioguanine, irinotecan). Linking genomic data with prescribing and hospital incidence records, a phenome-wide association study (PheWAS) was performed to identify whether phenotypes indicative of adverse drug reactions (ADRs) were enriched in drug-exposed individuals with the relevant PGx variants. In a subset of 7,081 patients with cancer, DPYD variants were reported back to clinicians and outcomes were collected. We identified clinically relevant PGx variants across the four genes in 62.7% of participants in our cohort. Extending this to annual prescription numbers in England for the drugs affected by these PGx variants, approximately 14,540 patients per year could potentially benefit from a reduced dose or alternative drug to reduce the risk of ADRs. Validating PGx associations in a real-world data set, we found a significant association between PGx variants in DPYD and toxicity-related phenotypes in patients treated with capecitabine or fluorouracil. Reported DPYD variants were deemed informative for clinical decision making in a majority of cases. Reporting PGx variants from germline WGS relevant to patients with cancer alongside primary findings related to their cancer can be clinically informative, informing prescribing to reduce the risk of ADRs. Extending the range of actionable variants to those found in patients of non-European ancestry is important and will extend the potential clinical impact.

Effect of high-dose vs. standard-dose quadrivalent influenza vaccine on death and hospitalizations in older adults with cardiovascular disease: a prespecified analysis of the DANFLU-1 study

Abstract Background The results of the DANFLU-1 trial indicated that high-dose quadrivalent influenza vaccines (HDQIV) as compared to standard-dose quadrivalent influenza vaccines (SDQIV) may reduce the incidence of death and hospitalization with pneumonia or influenza in older adults. Whether this effect differs by the presence of cardiovascular disease is unknown. Purpose To conduct a prespecified analysis aimed at assessing whether the presence of cardiovascular disease at baseline modified the effect of HDQIV vs SDQIV on clinical outcomes in the DANFLU-1 trial. Methods DANFLU-1 was a pragmatic, open-label trial randomizing 12,477 adults aged 65-79 years 1:1 to HDQIV vs SDQIV during the 2021/2022 influenza season. The trial used the Danish nationwide registers to collect both baseline and outcome data. Participants were included in October and November of 2021 and follow-up ended on May 31, 2022. In this prespecified analysis, we assessed the effectiveness of HDQIV vs SDQIV on clinical endpoints according to the presence of cardiovascular disease at baseline and across different cardiovascular subgroups including ischemic heart disease, heart failure and atrial fibrillation. Effectiveness was assessed with Cox proportional hazards regression. In addition, hospitalizations were also assessed with recurrent event analysis using negative binomial regression. Results The mean age of the 12,477 participants in the DANFLU-1 trial was 71.7 years (SD 3.9) and 6600 (53%) were male. During a median follow-up of 237 days (interquartile range 232-239 days), 62 participants died (0.5%), 38 (0.3%) were hospitalized with pneumonia or influenza, 220 (1.8%) were hospitalized with a cardiorespiratory diagnosis, and 192 (1.5%) were hospitalized with a cardiovascular diagnosis. HDQIV was associated with a lower incidence of death during follow-up as compared with SDQIV (HR 0.51 [95% CI 0.30-0.86], p=0.012), and this effect was consistent in participants with CVD and without CVD and across cardiovascular subgroups (Figure 1). HDQIV was also associated with a lower incidence of hospitalization with pneumonia or influenza (IRR 0.30 (95% CI 0.14-0.64, p=0.002), and this effect was consistent irrespective of CVD (subgroup estimates were inestimable due to low power) (Figure 2). There was no difference in the incidence of cardiorespiratory or cardiovascular hospitalization between the HDQIV and SDQIV group. No significant effect modification by the presence of CVD or cardiovascular subgroups was observed (Figure 1 and 2). Conclusions In this prespecified analysis of the DANFLU-1 randomized trial, high-dose influenza vaccine was associated with a reduced rate of death and hospitalization with influenza or pneumonia and this effect was consistent in participants with CVD and across cardiovascular subgroups.Figure 1:Time to event analysisFigure 2:Recurrent event analysis

Relationship between chronic obstructive pulmonary disease and heart failure hospitalization in patients with atrial fibrillation: the Fushimi AF Registry

Abstract Background Chronic heart failure and chronic obstructive pulmonary disease (COPD) are both common diseases and often co-exist. Patients with COPD are at increased risk for hospitalizations due to cardiovascular diseases. However, in patients with atrial fibrillation (AF), the relationship between COPD and the risk of heart failure (HF) hospitalization remains unclear. Purpose The purpose of this study was to investigate the relationship between COPD and HF hospitalization in AF patients. Methods The Fushimi AF Registry, a community-based prospective survey, was designed to enroll all of the AF patients in Fushimi-ku, Japan. Fushimi-ku is densely populated with a total population of 283,000 and is assumed to represent a typical urban community in Japan. We started to enroll patients from March 2011, and follow-up data were available for 4,496 patients by the end of February 2022. We compared patients with and without COPD with regard to clinical background and HF hospitalization during follow-up period. Results In this cohort, the proportion of pre-existing HF among patients with COPD was 30.1%, and the proportion of COPD among patients with pre-existing HF was 5.9%. Of 4,496 patients, 238 (5.3%) patients had COPD (COPD; the mean age 75.6 years, female 20.6%), and the remaining 4,258 patients did not (Non-COPD; the mean age 73.5 years, female 41.6%). Patients with COPD were older than those without COPD. However, the proportions of patients with pre-existing HF, previous stroke, vascular disease, cardiomyopathy, coronary artery disease (CAD), diuretic use, renal dysfunction, diabetes mellitus (DM) and hypertension were comparable. During the median follow-up period of 1,824 days, the incidence of HF hospitalization was significantly higher in COPD than in Non-COPD (COPD vs. Non-COPD; 4.85% vs. 3.01% per person-year: p&amp;lt;0.01). In multivariate analysis adjusted by sex, age (≥ 75 years), heart disease (combined by heart failure, vascular disease, cardiomyopathy and CAD), renal dysfunction, DM, hypertension and diuretic use, COPD was an independent risk factor for HF hospitalization (hazard ratio (HR) 1.54, 95% confidence interval (CI) 1.15-2.07, P&amp;lt;0.01) (Figure 1). When we analyzed patients without pre-existing HF, the incidence of HF hospitalization was also significantly higher in COPD than in Non-COPD (COPD vs. Non-COPD; 2.87% vs. 1.75% per person-year: p=0.02). In multivariate analysis after adjusting for the same factors, COPD was an independent risk factor for HF hospitalization (HR 1.63, 95% CI 1.05-2.53, P=0.03) (Figure 2). Conclusion In patients with AF, COPD was the risk of HF hospitalization. The results were consistent in AF patients without pre-existing HF.

Effect of renin-angiotensin system inhibitors in elderly patients with heart failure and reduced ejection fraction

Abstract Background More than half of the patients admitted for acute decompensated heart failure (ADHF) in Japan are over 80 years of age. Both Japanese and European heart failure guidelines recommend the use of renin-angiotensin system inhibitors (RASIs) in patients with heart failure with reduced ejection fraction (HFrEF). However, there is a paucity of data on the effect of RASIs in elderly patients with HFrEF, because elderly patients have been excluded from large clinical trials. Purpose The purpose of the current study was to clarify the effect of RASIs in elderly patients with HFrEF. Methods This was a post-hoc analysis of a prospective, observational, multicentre cohort study that enrolled consecutive patients admitted with ADHF to 19 secondary and tertiary hospitals in Japan between October 2014 and March 2016. Patients who were ≥ 80 years old, with left ventricular ejection fraction (LVEF) &amp;lt; 40% and discharged alive were included in the present study. RASIs were defined as either ACE inhibitors or angiotensin II receptor blockers. The primary endpoint was a composite of all-cause death and heart failure (HF) hospitalisation. Results Among 518 patients enrolled, 288 patients received RASIs at discharge and 230 patients did not. The median follow-up period was 335 days (interquartile range; 124 – 499 days). Patients receiving RASIs were younger (85.7 ± 4.4 vs. 86.5 ± 4.4 years of age, p=0.03), had a higher body mass index (BMI; 21.4 ± 3.3 vs. 20.6 ± 3.7 kg/m², p=0.01) and better renal function (eGFR; 45.4 ± 21.5 vs. 38.2 ± 19.2 ml/min/1.73m², p&amp;lt;0.001). Patients receiving RASIs had a higher LVEF (30.9 ± 6.3 vs. 28.5 ± 7.1%, p&amp;lt;0.001). The use of beta-blockers at discharge was more prevalent in patients receiving RASIs (77.8% vs. 60.4%, p&amp;lt;0.001), but the use of mineralocorticoid receptor antagonists was not (50.0% vs. 42.2%, p=0.08). The cumulative incidence of all-cause death or HF hospitalisation one year after discharge was significantly lower in patients receiving RASIs (40.1% vs. 59.5%, p&amp;lt;0.001). Even after adjusting for confounders, the risk of a composite of all-cause death and HF hospitalisation was significantly lower in patients receiving RASIs (adjusted hazard ratio 0.59, 95% confidence interval 0.45-0.77, p&amp;lt;0.001). There was no interaction between the effect of RASIs and subgroup factors such as age, BMI, dementia, malignancy, frailty, and renal function. Conclusion Use of RASIs at discharge was associated with lower incidence of all-cause death or HF hospitalisation in elderly patients with HFrEF.

Temporal trends in mortality and hospitalisation risk in patients with heart failure according to frailty status

Abstract Background Heart failure (HF) and frailty often coexist, and patients with both conditions have a higher risk of mortality and hospitalisation compared with those who are not frail. Over the past two decades, advances in medication targeting HF have been introduced, prolonging the life of patients with HF, but also resulting in increased comorbidity accumulation and susceptibility to frailty. It remains unknown how the interplay between HF and frailty at HF onset impacts patient prognosis and how this has changed over time. Purpose We investigated the temporal trends in the risk of all-cause mortality and HF hospitalisation in patients with HF from 1999 to 2017 according to their frailty status. Methods From Danish nationwide registers, we included patients with new-onset HF. Patients were categorised into four groups according to the year of HF onset: 1999-2002, 2003-2007, 2008-2012, and 2013-2017. The Hospital Frailty Risk Score was used to classify patients into frailty severity categories: 1) non-frail, 2) moderately frail, and 3) severely frail. The primary outcome was the 5-year cumulative incidence of all-cause mortality, assessed using the Kaplan-Meier estimator. The secondary outcome was the 5-year risk of HF hospitalisation, assessed using the Aalen-Johansen estimator, accounting for the competing risk of death. Moreover, a sensitivity analysis was conducted using a multivariable Cox proportional hazard model, investigating the interaction between year group and frailty status for all-cause mortality, comparing frail patients with non-frail patients. Results Among 131,235 patients with HF (median age 74 years; 39.7% female), 102,635 (78%) were categorised as non-frail, 26,054 (20%) as moderately frail, and 2609 (2%) as severely frail. The proportion of moderately frail patients increased the most, from 13% in 1999 to 25% in 2017. From 1999-2002 to 2003-2017, the 5-year cumulative incidence of all-cause mortality declined from 56.4% (95% CI, 55.8-57.0%) to 33.3% (32.6-34.1%), 79.8% (78.5-81.0%) to 58.6% (57.2-60.1%), and 90.8% (85.6-96.0%) to 79.8% (76.4-83.2%) in the non-frail, moderately frail, and severely frail patient group, respectively (Fig 1). The largest relative improvement was observed in the non-frail patient group. The 5-year cumulative incidence of HF hospitalisation remained fairly constant across the frailty groups (Fig 2). Conclusions From 1999 to 2017, we observed an increase in moderately and severely frail patients. Overall, the mortality risk decreased across all frailty groups. These findings underscore the importance of implementing guidelines directed at frail patients with HF.5-year risk of all-cause mortality5-year risk of HF hospitalisation

Early Intervention in Patients With Asymptomatic Severe Aortic Stenosis and Myocardial Fibrosis

Development of myocardial fibrosis in patients with aortic stenosis precedes left ventricular decompensation and is associated with an adverse long-term prognosis. To investigate whether early valve intervention reduced the incidence of all-cause death or unplanned aortic stenosis-related hospitalization in asymptomatic patients with severe aortic stenosis and myocardial fibrosis. This prospective, randomized, open-label, masked end point trial was conducted between August 2017 and October 2022 at 24 cardiac centers across the UK and Australia. Asymptomatic patients with severe aortic stenosis and myocardial fibrosis were included. The final date of follow-up was July 26, 2024. Early valve intervention with transcatheter or surgical aortic valve replacement or guideline-directed conservative management. The primary outcome was a composite of all-cause death or unplanned aortic stenosis-related hospitalization in a time-to-first-event intention-to-treat analysis. There were 9 secondary outcomes, including the components of the primary outcome and symptom status at 12 months. The trial enrolled 224 eligible patients (mean [SD] age, 73 [9] years; 63 women [28%]; mean [SD] aortic valve peak velocity of 4.3 [0.5] m/s) of the originally planned sample size of 356 patients. The primary end point occurred in 20 of 113 patients (18%) in the early intervention group and 25 of 111 patients (23%) in the guideline-directed conservative management group (hazard ratio, 0.79 [95% CI, 0.44-1.43]; P = .44; between-group difference, -4.82% [95% CI, -15.31% to 5.66%]). Of 9 prespecified secondary end points, 7 showed no significant difference. All-cause death occurred in 16 of 113 patients (14%) in the early intervention group and 14 of 111 (13%) in the guideline-directed group (hazard ratio, 1.22 [95% CI, 0.59-2.51]) and unplanned aortic stenosis hospitalization occurred in 7 of 113 patients (6%) and 19 of 111 patients (17%), respectively (hazard ratio, 0.37 [95% CI, 0.16-0.88]). Early intervention was associated with a lower 12-month rate of New York Heart Association class II-IV symptoms than guideline-directed conservative management (21 [19.7%] vs 39 [37.9%]; odds ratio, 0.37 [95% CI, 0.20-0.70]). In asymptomatic patients with severe aortic stenosis and myocardial fibrosis, early aortic valve intervention had no demonstrable effect on all-cause death or unplanned aortic stenosis-related hospitalization. The trial had a wide 95% CI around the primary end point, with further research needed to confirm these findings. ClinicalTrials.gov Identifier: NCT03094143.

Demographics and clinical outcomes of flow-gradient patterns of aortic stenosis: an analysis of the CURRENT AS Registry-2

Abstract Background Low-gradient (LG) severe aortic stenosis (AS) has not been fully characterized compared with high-gradient (HG) AS. Methods Among 3369 patients with severe AS enrolled in the CURRENT AS Registry-2, the current study population consisted of 3363 patients with data on left ventricular ejection fraction (LVEF) after excluding patients with LG AS without indexed stroke volume data. Patients were divided into 4 groups (LG AS with reduced LVEF: N=285, paradoxical low-flow low-gradient [LFLG] AS: N=220, normal-flow low-gradient [NFLG] AS: N=872, and HG AS: N=1986). Results Compared to HG AS, LG AS with reduced LVEF more often had cardiovascular comorbidities, advanced cardiac damage stages, and frailty with less extensive aortic valve (AV) calcification by computed tomography (CT), and paradoxical LFLG AS more often had atrial fibrillation, concomitant valvular disease, advanced cardiac damage stages, and frailty with less extensive AV calcification, while NFLG AS were less often symptomatic, and had comparable cardiac damage stages, and frailty with less extensive AV calcification. Patients with the 3 types of LG AS less often underwent surgical or transcatheter aortic valve replacement than those with HG AS (cumulative 3-year incidence: LG AS with reduced LVEF: 64.5%, paradoxical LFLG AS: 59.1%, NFLG AS: 54.2%, and HG AS: 87.3%, P&amp;lt;0.001). Cumulative 3-year incidence of death or heart failure hospitalization was much higher in patients with LG AS with reduced LVEF and paradoxical LFLG AS than in those with HG AS (cumulative 3-year incidence: LG AS with reduced LVEF: 65.9%, paradoxical LFLG: 51.1%, NFLG: 35.5%, and HG: 30.5%, P&amp;lt;0.001). After adjusting confounders, LG AS with reduced LVEF and paradoxical LFLG AS compared with HG AS were independently associated with higher risk for death or heart failure hospitalization (HR: 1.82, 95%CI: 1.49-2.23, P&amp;lt;0.001; HR 1.43, 95%CI: 1.13-1.82, P=0.003, respectively), but not NFLG AS (HR 1.03, 95%CI: 0.88-1.21, P=0.68). Conclusions Aortic stenosis might be less severe in LG AS than in HG AS when assessed by the CT calcium score of the aortic valve, and each of the 3 hemodynamic types of LG AS had distinct clinical, and echocardiographic characteristics as well as clinical outcomes that were different from HG AS.Different patterns of severe AS