Incidence Of Adverse Clinical Outcomes Research Articles

Exploration of the shared gene signatures and molecular mechanisms between Alzheimer’s disease and intracranial aneurysm

Although Alzheimer’s disease (AD) and intracranial aneurysm (IA) were two different types of diseases that occurred in the brain, ruptured IA (RIA) survivors may experience varying degrees of cognitive dysfunction. Neither AD nor IA is easily recognizable by an early onset so that the incidence of adverse clinical outcomes would be on the rise. Therefore, we focused on the exploration of the shared genes and molecular mechanisms between AD and IA, which would be significant for the efficiency of co-screening and co-diagnosis. Two GEO datasets were selected for the weighted gene co-expression network analysis (WGCNA) and differentially expressed gene screening, obtaining 78 overlapped genes. Next, 9 hub genes were identified by the protein-protein interaction network, including PIK3CA, GAB1, IGF1R, PLCB1, PGR, PDGFRB, PLCE1, FGFR3, and SYNJ1. The interactions among the hub genes, miRNA, and TFs were also explored. Meanwhile, we performed GO and KEGG pathway enrichment analyses for the results of WGCNA and hub genes, which showed that the Ras signaling and Rap1 signaling were the main shared pathogenesis. In conclusion, the present bioinformatics analysis revealed that AD and IA had the shared genes and molecular mechanisms, and these outcomes were associated with inflammation and calcium homeostasis, which could provide research clues for further studies.

Adherence to GLP1-RA and SGLT2-I affects clinical outcomes and costs in patients with type 2 diabetes.

To evaluate the impact of adherence to glucagon like peptide-1 receptor agonists (GLP1-RA) and sodium-glucose transporter two inhibitors (SGLT2-I) on clinical outcomes and costs in patients with type 2 diabetes mellitus (T2DM). The 121,115 residents of the Lombardy Region (Italy) aged ≥40years newly treated with metformin during 2007-2015 were followed to identify those who started therapy with GLP1-RA or SGLT2-I. Adherence to drug therapy over the first year was defined as the proportion of days covered >80%. Within each drug class, for each adherent patient, one non-adherent patient was matched for age, sex, duration, adherence to metformin treatment and propensity score. The primary clinical outcome was a composite of insulin initiation, hospitalisation for micro- and macrovascular complications and all-cause mortality after the first year of drug treatment. Costs were evaluated based on reimbursements from the national healthcare system. After matching, 1182 pairs of adherent and non-adherent GLP1-RA users and 1126 pairs of adherent and non-adherent SGLT2-I users were included. In both groups, adherent patients experienced a significantly lower incidence of the primary outcome (HR: 0.85, 95% CI 0.72-0.98 for GLP1-RA and HR: 0.69, 95% CI 0.55-0.87 for SGLT2-I). A significant reduction in hospitalizations was found for adherent patients in the GLP1-RA group but not for the SGLT2-I group. Results were consistent when analyses were stratified by age and sex. While higher drug-related costs in the adherent group were counterbalanced by decreased hospitalisation costs in SGLT2-I treated patients, this was not the case for GLP1-RA. Higher adherence to drug treatment with GLP1-RA and SGLT2-I during the first year of the drug intake is associated with a lower incidence of adverse clinical outcomes in a real-world setting.

The association between sarcopenia and incident of depressive symptoms: a prospective cohort study

BackgroundEpidemiological studies have shown that sarcopenia was associated with depression among older adults. However, most of these investigations used a cross-sectional design, limiting the ability to establish a causal relation, the present study examined whether sarcopenia was associated with incident depressive symptoms.MethodsThis is a prospective cohort study with participants from the Western China Health and Aging Trends (WCHAT) study. Participants could complete anthropometric measurements and questionnaires were included. The exposure was sarcopenia, defined according to the Asian Working Group for Sarcopenia in 2019, the outcome was depressive symptoms, evaluated by GDS-15. We excluded depression and depressive symptoms at baseline and calculated the risk of incident depressive symptoms during the follow-up year.ResultsA total of 2612 participants (mean age of 62.14 ± 8.08 years) were included, of which 493 with sarcopenia. 78 (15.82%) participants with sarcopenia had onset depressive symptoms within the next year. After multivariable adjustment, sarcopenia increased the risk of depressive symptoms (RR = 1.651, 95%CI = 1.087–2.507, P = 0.0187) in overall participants. Such relationship still exists in gender and sarcopenia severity subgroups. Low muscle mass increased the risk of depressive symptoms (RR = 1.600, 95%CI = 1.150–2.228, P = 0.0053), but low muscle strength had no effect (RR = 1.250, 95%CI = 0.946–1.653, P = 0.117).ConclusionsSarcopenia is an independent risk factor for depressive symptoms, Precautions to early detect and targeted intervene for sarcopenia should continue to be employed in adult with sarcopenia to achieve early prevention for depression and reduce the incidence of adverse clinical outcomes.

Real-World Incidence of Adverse Clinical Outcomes Among People With Coronary Artery Disease and/or Peripheral Artery Disease in Relation to Vascular Risk in the United States

Presence of polyvascular disease, diabetes, heart failure, or renal insufficiency in patients with chronic coronary artery disease (CAD) and peripheral artery disease (PAD) are associated with increased risks of adverse events, including major adverse cardiovascular events (MACEs) and major adverse limb events (MALEs). In this retrospective observational study using administrative claims data from Optum's deidentified Clinformatics Data Mart Database from January 2016 to September 2021, we described the incidence rates of MACEs, MALEs, and major thrombotic vascular events in patients with CAD or PAD stratified by the presence of risk factors (i.e., polyvascular disease, diabetes, heart failure, or renal insufficiency). A total of 1,435,241 patients (77% CAD and 34% PAD) met the inclusion and exclusion criteria. Patients with 0 risk factors were deemed the low-risk group (47%; n=681,333) and patients with ≥1 risk factor were deemed the high-risk group (53%; n=753,908). The mean age was 71.8 and 73.6years, and 42% and 44% were female in the low- and high-risk groups, respectively. Compared with the low-risk group, the high-risk group had a 72% higher hazard of developing MACEs (adjusted hazard ratio 1.72, 95% confidence interval 1.70 to 1.74), 82% higher hazard of developing major thrombotic vascular events (1.82, 1.80 to 1.84), and 146% higher hazard of developing MALEs (2.46, 2.39 to 2.53) (all p <0.001). In conclusion, in patients with CAD or PAD, the presence of 1 or more risk factors was associated with higher risks of MACEs, MALEs, and major thrombotic vascular events, underscoring the need to improve management of underlying diseases in this population.

Adverse Outcomes, Healthcare Resource Utilization, and Costs Associated with Systemic Corticosteroid use Among Adults with Systemic Lupus Erythematosus in the UK.

This analysis was conducted to assess the incidence of adverse clinical outcomes, healthcare resource use (HCRU), and the costs associated with systemic corticosteroid (SCS) use in adults with systemic lupus erythematosus (SLE) in the UK. We identified incident SLE cases using the Clinical Practice Research Datalink GOLD, Hospital Episode Statistics-linked healthcare, and Office for National Statistics mortality databases from January 1, 2005, to June 30, 2019. Adverse clinical outcomes, HCRU, and costs were captured for patients with and without prescribed SCS. Of 715 patients, 301 (42%) had initiated SCS use (mean [standard deviation (SD)] 3.2 [6.0] mg/day) and 414 (58%) had no recorded SCS use post-SLE diagnosis. Cumulative incidence of any adverse clinical outcome over 10-year follow-up was 50% (SCS group) and 22% (non-SCS group), with osteoporosis diagnosis/fracture most frequently reported. SCS exposure in the past 90days was associated with an adjusted hazard ratio of 2.41 (95% confidence interval 1.77-3.26) for any adverse clinical outcome, with increased hazard for osteoporosis diagnosis/fracture (5.26, 3.61-7.65) and myocardial infarction (4.52, 1.16-17.71). Compared to low-dose SCS (< 7.5mg/day), patients on high-dose SCS (≥ 7.5mg/day) had increased hazard for myocardial infarction (14.93, 2.71-82.31), heart failure (9.32, 2.45-35.43), osteoporosis diagnosis/fracture (5.14, 2.82-9.37), and type 2 diabetes (4.02 1.13-14.27). Each additional year of SCS use was associated with increased hazard for any adverse clinical outcome (1.15, 1.05-1.27). HCRU and costs were greater for SCS users than non-SCS users. Among patients with SLE, there is a higher burden of adverse clinical outcomes and greater HCRU in SCS versus non-SCS users.

Clinical outcomes in heart failure patients with and without atrial fibrillation receiving sodium-glucose cotransporter-2 inhibitor.

We report a retrospective analysis of a nationwide health database to study the association between sodium-glucose cotransporter-2 inhibitor (SGLT2I) use and the incidence of adverse clinical outcomes among heart failure (HF) patients with and without atrial fibrillation (AF) stratified by CHA2DS2-VASc score. The outcome of this study was on the development of adverse events, including acute myocardial infarction (AMI), hemorrhagic stroke, ischemic stroke, cardiovascular (CV) death, and all-cause mortality. By dividing the number of adverse events by the total person-years, the incidence rate was calculated. The hazard ratio (HR) was estimated by the Cox proportional hazard model. A total of 95% confidence interval (CI) was also presented to show the risk of adverse events for HF patients with and without AF taking SGLT2I. SGLT2I users had a lower risk of AMI (adjusted HR = 0.83; 95% CI = 0.74, 0.94), CV death (adjusted HR = 0.47; 95% CI = 0.42, 0.51), and all-cause death (adjusted HR = 0.39; 95% CI = 0.37, 0.41). Considering HF patients without AF and SGLT2I as the reference group, HF patients without AF but with SGLT2I had a reduced risk of adverse outcomes of 0.48 (95% CI = 0.45, 0.50), and HF patients with AF and SGLT2I had the decreased hazard ratio of 0.55 (95% CI = 0.50, 0.61). The adjusted HR of adverse outcomes for HF patients with CHA2DS2-VASc score less than 2 and SGLT2I without and with AF relative to HF patients without AF nor SGLT2I were 0.53 (95% CI = 0.41, 0.67) and 0.24 (95% CI = 0.12, 0.47), respectively. Compared to HF patients with no history of AF and SGLT2I, if patients additionally with SGLT2I and CHA2DS2-VASc score ≥ 2, the risk of the adverse outcomes was reduced with adjusted HR of 0.48 (95% CI = 0.45, 0.50); if patients additionally with AF and CHA2DS2-VASc score ≥ 2, the risk of the adverse outcomes was decreased with adjusted HR of 0.88 (95% CI = 0.80, 0.97); if patients additionally with AF, SGLT2I, and CHA2DS2-VASc score ≥ 2, the risk of the adverse outcomes was diminished with adjusted HR of 0.52 (95% CI = 0.47, 0.58). We concluded that SGLT2I has a protective effect in HF patients, and the risk reduction is greater with a score of < 2 and without AF.

Impact of mental disorders on clinical outcomes of physical diseases: an umbrella review assessing population attributable fraction and generalized impact fraction.

Empirical evidence indicates a significant bidirectional association between mental disorders and physical diseases, but the prospective impact of men-tal disorders on clinical outcomes of physical diseases has not been comprehensively outlined. In this PRISMA- and COSMOS-E-compliant umbrella review, we searched PubMed, PsycINFO, Embase, and Joanna Briggs Institute Database of Systematic Reviews and Implementation Reports, up to March 15, 2022, to identify systematic reviews with meta-analysis that examined the prospective association between any mental disorder and clinical outcomes of physical diseases. Primary outcomes were disease-specific mortality and all-cause mortality. Secondary outcomes were disease-specific incidence, functioning and/or disability, symptom severity, quality of life, recurrence or progression, major cardiac events, and treatment-related outcomes. Additional inclusion criteria were further applied to primary studies. Random effect models were employed, along with I2 statistic, 95% prediction intervals, small-study effects test, excess significance bias test, and risk of bias (ROBIS) assessment. Associations were classified into five credibility classes of evidence (I to IV and non-significant) according to established criteria, complemented by sensitivity and subgroup analyses to examine the robustness of the main analysis. Statistical analysis was performed using a new package for conducting umbrella reviews (https://metaumbrella.org). Population attributable fraction (PAF) and generalized impact fraction (GIF) were then calculated for class I-III associations. Forty-seven systematic reviews with meta-analysis, encompassing 251 non-overlapping primary studies and reporting 74 associations, were included (68% were at low risk of bias at the ROBIS assessment). Altogether, 43 primary outcomes (disease-specific mortality: n=17; all-cause mortality: n=26) and 31 secondary outcomes were investigated. Although 72% of associations were statistically significant (p<0.05), only two showed convincing (class I) evidence: that between depressive disorders and all-cause mortality in patients with heart failure (hazard ratio, HR=1.44, 95% CI: 1.26-1.65), and that between schizophrenia and cardiovascular mortality in patients with cardiovascular diseases (risk ratio, RR=1.54, 95% CI: 1.36-1.75). Six associations showed highly suggestive (class II) evidence: those between depressive disorders and all-cause mortality in patients with diabetes mellitus (HR=2.84, 95% CI: 2.00-4.03) and with kidney failure (HR=1.41, 95% CI: 1.31-1.51); that between depressive disorders and major cardiac events in patients with myocardial infarction (odds ratio, OR=1.52, 95% CI: 1.36-1.70); that between depressive disorders and dementia in patients with diabetes mellitus (HR=2.11, 95% CI: 1.77-2.52); that between alcohol use disorder and decompensated liver cirrhosis in patients with hepatitis C (RR=3.15, 95% CI: 2.87-3.46); and that between schizophrenia and cancer mortality in patients with cancer (standardized mean ratio, SMR=1.74, 95% CI: 1.41-2.15). Sensitivity/subgroup analyses confirmed these results. The largest PAFs were 30.56% (95% CI: 27.67-33.49) for alcohol use disorder and decompensated liver cirrhosis in patients with hepatitis C, 26.81% (95% CI: 16.61-37.67) for depressive disorders and all-cause mortality in patients with diabetes mellitus, 13.68% (95% CI: 9.87-17.58) for depressive disorders and major cardiac events in patients with myocardial infarction, 11.99% (95% CI: 8.29-15.84) for schizophrenia and cardiovascular mortality in patients with cardiovascular diseases, and 11.59% (95% CI: 9.09-14.14) for depressive disorders and all-cause mortality in patients with kidney failure. The GIFs confirmed the preventive capacity of these associations. This umbrella review demonstrates that mental disorders increase the risk of a poor clinical outcome in several physical diseases. Prevention targeting mental disorders - particularly alcohol use disorders, depressive disorders, and schizophrenia - can reduce the incidence of adverse clinical outcomes in people with physical diseases. These findings can inform clinical practice and trans-speciality preventive approaches cutting across psychiatric and somatic medicine.

Cost-Effectiveness of Dapagliflozin as a Treatment for Chronic Kidney Disease: A Health-Economic Analysis of DAPA-CKD.

CKD imposes a significant burden on patients and health care providers, particularly upon reaching kidney failure when patients may require KRT. The Dapagliflozin and Prevention of Adverse Outcomes in CKD (DAPA-CKD) trial demonstrated that dapagliflozin, with standard therapy, reduced CKD progression and KRT requirement. The study objective was to estimate the cost-effectiveness of dapagliflozin for the treatment of CKD from payer perspectives in the United Kingdom, Germany, and Spain. We constructed a lifetime Markov model to characterize outcomes in patients with CKD on the basis of the DAPA-CKD trial. Health states were defined by eGFR level and KRT type. Direct health care costs and utility values were sourced from published literature and the DAPA-CKD trial, respectively. Costs and benefits were discounted at 3.5% per annum in the United Kingdom and 3% in Germany and Spain. In patients eligible for the DAPA-CKD trial, treatment with dapagliflozin was predicted to reduce rates of CKD progression, with patients predicted to spend 1.7 (95% credibility interval, 0.8 to 2.4) more years in the eGFR range 15-89 ml/min per 1.73 m2 versus standard therapy alone (12.1; 95% credibility interval, 8.9 to 14.1 versus 10.4; 95% credibility interval, 7.7 to 12.4 years). Life expectancy (undiscounted) was correspondingly predicted to increase by 1.7 (95% credibility interval, 0.7 to 2.5) years (15.5; 95% credibility interval, 11.1 to 18.2 versus 13.8; 95% credibility interval, 9.9 to 16.5 years). This in addition to reduced incidence of adverse clinical outcomes, including hospitalization for heart failure, resulted in modeled quality-adjusted life year (discounted) gains between 0.82 (95% credibility interval, 0.38 to 1.18) and 1.00 (95% credibility interval, 0.46 to 1.41). These gains translated to incremental cost-effectiveness ratios of $8280, $17,623, and $11,687 in the United Kingdom, Germany, and Spain, respectively, indicating cost-effectiveness at willingness-to-pay thresholds (United Kingdom: $27,510 per quality-adjusted life year; Germany and Spain: $35,503 per quality-adjusted life year). In patients meeting the eligibility requirements for the DAPA-CKD trial, dapagliflozin is likely to be a cost-effective treatment within the UK, German, and Spanish health care systems. Dapagliflozin and Prevention of Adverse Outcomes in CKD (DAPA-CKD), NCT03036150.

Elevated Donor-Derived Cell-Free DNA (dd-cfDNA) in the Early Post-Transplant Period Is Associated With an Increased Incidence of Adverse Clinical Outcomes in Kidney Transplant Recipients

Elevated Donor-Derived Cell-Free DNA (dd-cfDNA) in the Early Post-Transplant Period Is Associated With an Increased Incidence of Adverse Clinical Outcomes in Kidney Transplant Recipients

336.2: Elevated Donor-Derived Cell-Free DNA (Dd-cfDNA) in the Early Post-transplant Period Is Associated With an Increased Incidence of Adverse Clinical Outcomes in Kidney Transplant Recipients

Introduction: Early post-transplant elevations in dd-cfDNA, even in the absence of histologic rejection or other overt pathology, have been suggested to carry a riskof adverse outcomes among solid organ transplant recipients. We investigated this association among kidney transplant recipients enrolled in the Kidneyallograft Outcomes AlloSure Registry (KOAR, NCT03326076). Methods: To assess the impact of early post-transplant dd-cfDNA elevations, we evaluated the incidence of a clinical composite that included biopsy-provenrejection (BPAR), detection of de novo donor specific antibodies (dnDSA) and return to dialysis in patients with and without median dd-cfDNA >1% over the first100 days post-transplant. Patients with events before day 100 were excluded. Univariate and multivariate analyses were performed. Results: 51 of 1296 patients (3.9%) had a median dd-cfDNA ≥1.0% during the first 100 days post-transplant. In a univariate model, these patients had asignificantly higher risk of the experiencing both the composite outcome and each individual component during the first post-transplant year (Figure 1). In a multivariate Cox proportional hazards model that included recipient age, delayed graft function, donor type (living vs deceased), and recipient sensitization,only 100-day median dd-cfDNA elevation ≥1.0% was a statistically significant predictor of the composite outcome, with a hazard ratio of 2.99 (95% CI: 1.59 -5.61, p < 0.005) (Table 1). Conclusions: Our findings suggest that early post-transplant elevations in dd-cfDNA among kidney transplant recipients, even in the absence of clearimmunologic or histologic correlates, identify a population of patients at risk for adverse clinical outcomes during the first post-transplant year. Molecular risk-stratification using dd-cfDNA may have implications for clinical surveillance and therapeutic management of these patients.

EE272 Economic Burden Associated with ISO-Osmolar Versus Low Osmolar Iodinated Contrast Media during Peripheral Endovascular Procedures: Evidence from Premier Database

Iodinated contrast media are used in most interventional revascularization procedures. Several prior studies have demonstrated lower incidence of adverse clinical outcomes associated with iso-osmolar iodinated contrast media (IOCM) compared with low-osmolar contrast media (LOCM), including a recent analysis in comorbid patients with peripheral arterial disease (PAD). The objective of this study was to evaluate association of IOCM and LOCM use with direct costs and length of hospital stay in PAD patients undergoing endovascular interventions.

Trends in characteristics and outcomes among US adults hospitalised with COVID-19 throughout 2020: an observational cohort study

ObjectivesTo examine the temporal patterns of patient characteristics, treatments used and outcomes associated with COVID-19 in patients who were hospitalised for the disease between January and 15 November 2020.DesignObservational cohort...

ADVERSE CLINICAL OUTCOMES IN PATIENTS WITH ULCERATIVE COLITIS RECEIVING DIFFERENT SEQUENCES OF FIRST- AND SECOND-LINE BIOLOGIC TREATMENTS: FINDINGS FROM ROTARY

Abstract INTRODUCTION Inadequate response, loss of response, or intolerance to a first-line biologic typically requires patients with ulcerative colitis (UC) to switch treatment to a second-line biologic therapy. However, the clinical outcomes of patients receiving different sequences of biologic treatment are poorly understood. We assessed the adverse clinical outcomes of different treatment sequences. METHODS ROTARY (Real wOrld ouTcomes Across tReatment sequences in inflammatorY bowel disease patients) part B used data from the Optum Clinical Database and included adult patients diagnosed with UC who received at least two biologics successively between January 1, 2013 and February 29, 2020. This retrospective cohort study measured adverse clinical outcomes, including the incidences of inflammatory bowel disease (IBD)-related hospitalization, IBD-related surgery, dysplasia, colorectal cancer (CRC), and infection during each line of therapy individually and for both lines of treatment overall. The start of the first line of therapy (LOT1) was defined as the date of first prescription or infusion of a biologic therapy. The start of the second line of therapy (LOT2) was defined as the first date of prescription or infusion of a second-line biologic therapy. LOT1 biologics included in the analysis were adalimumab (ADA), infliximab (IFX), and vedolizumab (VDZ). LOT2 biologics included were IFX and ADA. RESULTS Among all treatment sequences the overall incidences of hospitalization, surgery, CRC, dysplasia, and infection were lowest for the VDZ to ADA treatment sequence (Figure 1). Patients who received VDZ to IFX had similar overall incidences of adverse outcomes as patients who received two sequential anti-tumor necrosis factor (TNF) therapies (either ADA to IFX or IFX to ADA) (Figure 1). When comparing adverse outcomes during LOT2 there were lower incidences of hospitalization and surgery for the IFX to ADA sequence compared with the ADA to IFX sequence (19.17% vs 23.64% and 7.14% vs 14.24%, respectively) (Table 1). When comparing adverse outcomes on LOT2 for the VDZ to ADA and VDZ to IFX sequences, there were lower incidences of hospitalization and surgery with VDZ to ADA compared with VDZ to IFX (12.50% vs 26.89% and 3.13% vs 22.69%, respectively) (Table 1). DISCUSSION In this real-world assessment of biologic treatment sequences in UC, we identified the VDZ to ADA treatment sequence to be associated with the lowest incidence of adverse clinical outcomes. In patients who were unsuccessfully treated with VDZ, ADA as a second-line biologic therapy was associated with lower incidences of adverse clinical outcomes compared with IFX. Although our results could be influenced by selection bias, these data provide potential guidance to clinicians in sequencing biologic therapies in patients with UC.

ADVERSE CLINICAL OUTCOMES IN PATIENTS WITH CROHN’S DISEASE RECEIVING DIFFERENT SEQUENCES OF FIRST- AND SECOND-LINE BIOLOGIC TREATMENTS: FINDINGS FROM ROTARY

Abstract INTRODUCTION Following inadequate response, loss of response, or intolerance to a first-line biologic, patients with Crohn’s disease (CD) may switch treatment to a second-line biologic therapy. Data on the clinical outcomes of patients receiving two or more lines of biologic therapy are limited. We assessed the adverse clinical outcomes of patients with CD receiving different biologic treatment sequences. METHODS ROTARY (Real-wOrld ouTcomes Across tReatment sequences in inflammatorY bowel disease patients) part B used data from the Optum Clinical Database and included adult patients diagnosed with CD who received at least two biologics successively between January 1, 2013 and February 29, 2020. This retrospective cohort study measured adverse clinical outcomes, including the incidences of inflammatory bowel disease (IBD)-related hospitalization, IBD-related surgery, dysplasia, colorectal cancer (CRC), and infection during each line of therapy individually and for both lines of treatment overall. The start of the first line of therapy (LOT1) was defined as the date of first prescription or infusion of a biologic therapy. The start of the second line of therapy (LOT2) was defined as the first date of prescription or infusion of a second-line biologic therapy. LOT1 biologics included in the analysis were adalimumab (ADA), infliximab (IFX), ustekinumab (UST) and vedolizumab (VDZ). LOT2 biologics included were IFX and ADA. RESULTS Among all treatment sequences UST to IFX had the highest overall incidences of hospitalization, surgery, CRC, and infection. The overall incidences of hospitalization, surgery, and CRC were lowest for the VDZ to ADA treatment sequence. The overall incidences of infection and dysplasia were lowest for UST to ADA and UST to IFX, respectively; the second-lowest overall incidences for these outcomes were for VDZ to ADA (Figure 1). When comparing adverse clinical outcomes during LOT2, there were similar incidences of hospitalization, surgery, dysplasia, and infection with ADA following either VDZ or UST. In comparison, UST to IFX had higher incidences of hospitalization, surgery, and infection compared with VDZ to IFX (Table 1). DISCUSSION We identified that the VDZ to ADA biologic treatment sequence had the lowest real-world incidences of adverse clinical outcomes in patients with CD. In patients who were unsuccessfully treated with either VDZ or UST during LOT1, ADA was associated with a lower incidence of adverse clinical outcomes during LOT2 than IFX. The adverse clinical outcomes for sequences including two anti-tumor necrosis factor therapies (ADA to IFX, IFX to ADA) were similar during LOT1, LOT2, and overall. These results, although they may be influenced by selection bias, provide potential guidance to clinicians choosing sequences of biologic treatments in patients with CD.

Effect of Early Nutritional Assessment and Nutritional Support on Immune Function and Clinical Prognosis of Critically Ill Children.

The aim of this study was to study the effect of early nutritional assessment and nutritional support on immune function and clinical prognosis of critically ill children. 90 critically ill children at the same level of severity admitted to the pediatric intensive care unit (PICU) of our hospital (June 2019–June 2020) were chosen as the research objects and were equally separated into the experimental group and the control group by the random number table method. The children in the control group were admitted to the PICU according to the routine process, and the nutritional support was provided to the malnourished ones. After admission to the PICU, the children in the experimental group were given nutritional assessment, nutritional risk screening, and nutritional support according to the screening results. The PICU stay time and total hospitalization time of the experimental group were obviously shorter than those of the control group (P < 0.05), the hospitalization expenses of the experimental group were obviously lower than those of the control group (P < 0.05), the clinical outcomes and immune function of the experimental group were obviously better than those of the control group (P < 0.05), and the nutrition indicators of the experimental group were obviously higher than those of the control group (P < 0.05). Early nutritional assessment and nutritional support can effectively improve the immune function and reduce the incidence of adverse clinical outcomes of critically ill children, which are worthy of clinical application and promotion.

The Impact of Smoking on Clinical Outcomes after Percutaneous Coronary Intervention in Women Compared to Men.

Background For decades, cardiovascular diseases (CVD) have been known as men's disease. However, recent research studies showed that they have become more common in women. Smoking is a strong risk factor for CVD especially that of coronary artery disease (CAD). Several studies reported that women are more susceptible to drastic sequels of smoking than men. There is limited data regarding the impact of smoking on post-revascularization clinical events stratified by gender. This study aimed to investigate if gender significantly changes the incidence of adverse clinical outcomes after percutaneous coronary intervention (PCI) among those with history of smoking. Methods Participants were selected from two hospitals from 2003 to 2019. Among patients who had PCI (index PCI), those with stable CAD who underwent elective PCI were included. Exclusion criteria were defined as primary PCI and those with multiple prior revascularizations. Participants were followed up seeking for major adverse cardiac events (MACE) including revascularization (PCI or coronary artery bypass grafting), myocardial infarction, and coronary death in three time intervals according to the time of index PCI (short term: up to 24 hours, mid-term: 24 hours to less than 6 months, and long term: more than 6 months). Results Of the 1799 patients, 61% were men and 47.08% had history of smoking (75% of the smokers were men). At the time of index PCI, smokers were significantly younger than nonsmokers. Also, MACE were significantly higher in smokers than nonsmokers, which was particularly pronounced at the long-term interval. In the nonsmokers group, there was no difference in MACE occurrence between men and women. However, of the smokers, women showed significantly higher MACE rate compared with men peers. Conclusion Smoking makes women more prone to MACE in comparison to men among patients with stable CAD after PCI with drug-eluting stent.

Prognostic impact of electrocardiographic left ventricular hypertrophy following transcatheter aortic valve replacement

BackgroundLeft ventricular hypertrophy (LVH) develops with both structural and electrical remodeling in response to elevated afterload due to aortic stenosis (AS). This study evaluated the prognostic value of electrocardiographic LVH (ECG LVH) after transcatheter aortic valve replacement (TAVR). MethodsA retrospective study including 157 consecutive patients who underwent TAVR was conducted. ECG LVH was defined as Sokolow–Lyon voltage (S in V1 + R in V5/6) before TAVR was ≥3.5mV. We investigated the association between ECG LVH and the 1-year composite outcome comprising all-cause death and rehospitalization related to heart failure. ECG and echocardiographic measurements at 1, 6, and 12 months after TAVR were assessed. ResultsThe baseline characteristics were comparable between the ECG LVH (n = 74) and non-ECG LVH groups (n = 83). The ECG LVH was associated with a significantly greater reduction of Sokolow–Lyon voltage and LV mass index than the non-ECG LVH after TAVR. The absence of ECG LVH was an independent predictor of the 1-year composite outcome [adjusted hazard ratio (HR), 2.27; 95% confidence interval (CI), 1.01 – 5.60; p = 0.04]. Furthermore, a reduction of Sokolow–Lyon voltage from baseline to 1-month follow-up, but not a reduction of LV mass index, was associated with a lower cumulative composite outcome from 1 month to 1 year (adjusted HR, 0.36; 95% CI, 0.15 – 0.86; p = 0.02). ConclusionsECG LVH was associated with a low incidence of adverse clinical outcomes and greater reverse LV remodeling after TAVR. Preprocedural and serial LVH assessment by ECG might be useful in AS patients undergoing TAVR.

Abstract 16345: Increase in Serum Chloride Level During Hospitalization Leads to Improved Clinical Outcomes in Patients With Heart Failure

Introduction: Serum chloride levels both at admission and at discharge in patients with heart failure (HF) are independently associated with the incidence of adverse clinical outcomes. However, there has been few reports focusing on the prognostic impact of the change in serum chloride level during the hospitalization on the long-term prognosis after discharge. Hypothesis: We thus hypothesized that changes in serum chloride during the hospitalization is an independent prognostic predictor after discharge in HF patients. Methods: This observational study included 1,913 consecutive patients who admitted to hospital due to worsening of HF and discharged alive in a single university hospital. After excluding patients who received regular hemodialysis, 1,762 patients were ultimately analyzed. The primary endpoint of this study was death from any cause. Result: Overall serum chloride level was significantly decreased from the admission to discharge (103 [100-106] mEq/L to 102 [99-105] mEq/L, P&lt;0.001). During the observation period with 512 days of median follow-up, 286 patients (16.2%) died. Multivariate Cox regression analysis revealed that increase in serum chloride level during the index hospitalization was independently associated with lower rates of mortality, even after the adjustment of diverse covariates including serum chloride level at admission (hazard ratio (HR): 0.94, 95% confidence interval: 0.90-0.98). When dividing the study population into tertiles by chloride levels at admission, patients with the lower baseline chloride level had the greater reduction in HR of the primary endpoint by the increase of chloride level during the hospitalization (Figure). Conclusion: Increase in serum chloride level during hospitalization may be associated with better post-discharge prognosis in HF patients. This could be a new therapeutic target for heart failure to improve long-term prognosis.

Abstract 16009: Sex Differences in Patients With Suspected Cardiac Sarcoidosis

Introduction: Cardiac sarcoidosis is increasingly recognized as a cause of cardiomyopathy and mortality. However, there are no data on sex differences in patients with suspected cardiac sarcoidosis. Hypothesis: We hypothesized that sex differences exist in the clinical presentation, cardiac involvement, and long-term clinical outcomes of patients with suspected cardiac sarcoidosis. Methods: We performed a retrospective cohort study to examine sex differences in presenting features, CMR findings, and the long-term incidence of adverse clinical outcomes among consecutive patients with histologically proven sarcoidosis and suspected cardiac involvement investigated by cardiovascular magnetic resonance imaging (CMR). The primary composite clinical endpoint was all-cause mortality or significant ventricular arrhythmia. The secondary endpoints were all-cause mortality and significant ventricular arrhythmia. Results: Among 324 patients, 163 (50.3%) were women and 161 (49.7%) were men. Women reported a greater prevalence of chest pain and palpitations than men, but not dyspnea, presyncope, or syncope. Women were less likely to have LGE or meet the criteria for a clinical diagnosis of cardiac sarcoidosis, indicating lesser cardiac involvement. The long-term incidence of the primary composite endpoint (hazard ratio for women 1.36; 95% confidence interval 0.77-2.43; p = 0.29; Figure 1 ) or the cause of death between women and men (p = 0.62). However, women had a significantly lower cumulative incidence of significant ventricular arrhythmia compared with men (4.3% vs. 13.0%; log-rank p = 0.022). Conclusions: There were distinct sex differences in patients with histologically proven sarcoidosis and suspected cardiac involvement. A paradox was noted wherein women had a greater prevalence of chest pain and palpitations than men, but had lesser cardiac involvement, and a similar long-term incidence of all-cause death or significant ventricular arrhythmia.

Management and outcomes of anastomotic leakage after McKeown esophagectomy: A retrospective analysis of 749 consecutive patients with esophageal cancer

PurposeCervical anastomotic leakages may manifest either cervically or intrathoracically. We retrospectively investigated the management strategies and clinical outcomes of patients who developed anastomotic leakages after McKeown esophagectomy and the spectrum of its clinical manifestations. MethodsPatients with esophageal cancer who underwent McKeown esophagectomy with cervical anastomosis (n = 749) between January 2015 and December 2018 were included. ResultsCervical anastomosis leakage was diagnosed in 53/749 (7.3%) patients. The leakage was primarily limited to cervical region in 16 (30.2%) patients, whereas intrathoracic spread was present in 37 (69.8%) patients. Intrathoracic manifestations were more commonly accompanied by fever (75.7% vs. 18.8%, P < 0.001) and leukocytosis than cervical manifestations (81.1% vs. 25.0%, P < 0.001). Compared to patients with cervical manifestations, those with intrathoracic manifestations had a longer duration of hospital stay (median; 58 vs. 40 days, P = 0.006) and higher incidence of tracheal fistula (21.6% vs. 0%, P = 0.045). Drainage through the neck wound was effective in all patients with cervical manifestations. Patients with intrathoracic manifestations who had transnasal inner drain or mediastinal drain placed intraoperatively achieved satisfactory drainage (27/37, 73.0%). Subsequent healing of anastomotic leaks was observed in 50 (94.3%) patients. There was no mortality associated with complications related to anastomotic leakage. ConclusionIntrathoracic manifestations of cervical anastomotic leakage are common in patients after McKeown esophagectomy. However, they are diagnosed later and are associated with more severe clinical consequences than cervical manifestations. Thus, a high index of suspicion and an early intervention policy for such anastomotic leaks should be adopted and strengthened to decrease the incidence of adverse clinical outcomes.