Differences In Baseline Variables Research Articles

Cost-Effectiveness of Late Endovascular Thrombectomy vs. Best Medical Management in a Clinical Trial Setting and Real-World Setting.

To assess cost-effectiveness of late time-window endovascular treatment (EVT) in a clinical trial setting and a "real-world" setting. Data are from the randomized ESCAPE trial and a prospective cohort study (ESCAPE-LATE). Anterior circulation large vessel occlusion patients presenting > 6 hours from last-known-well were included, whereby collateral status was an inclusion criterion for ESCAPE but not ESCAPE-LATE. A Markov state transition model was built to estimate lifetime costs and quality-adjusted life-years (QALYs) for EVT in addition to best medical care vs. best medical care only in a clinical trial setting (comparing ESCAPE-EVT to ESCAPE control arm patients) and a "real-world" setting (comparing ESCAPE-LATE to ESCAPE control arm patients). We performed an unadjusted analysis, using 90-day modified Rankin Scale(mRS) scores as model input and analysis adjusted for baseline factors. Acceptability of EVT was calculated using upper/lower willingness-to-pay thresholds of 100,000 USD/50,000 USD/QALY. Two-hundred and forty-nine patients were included (ESCAPE-LATE:n = 200, ESCAPE EVT-arm:n = 29, ESCAPE control-arm:n = 20). Late EVT in addition to best medical care was cost effective in the unadjusted analysis both in the clinical trial and real-world setting, with acceptability 96.6%-99.0%. After adjusting for differences in baseline variables between the groups, late EVT was marginally cost effective in the clinical trial setting (acceptability:49.9%-61.6%), but not the "real-world" setting (acceptability:32.9%-42.6%). EVT for LVO-patients presenting beyond 6 hours was cost effective in the clinical trial setting and "real-world" setting, although this was largely related to baseline patient differences favoring the "real-world" EVT group. After adjusting for these, EVT benefit was reduced in the trial setting, and absent in the real-world setting.

Impact of Antenatal Care Modifications on Gestational Diabetes Outcomes During the COVID-19 Pandemic

BackgroundMany of the adverse outcomes of gestational diabetes mellitus (GDM) are linked to excessive fetal growth, which is strongly mediated by the adequacy of maternal glycemic management. The COVID-19 pandemic led to a rapid adoption of virtual care models. We aimed to compare glycemic management, fetal growth, and perinatal outcomes before and during the COVID-19 pandemic. MethodsA retrospective cohort study was conducted between 2017 and 2020. Singleton pregnancies complicated by GDM were included in the study. The cohort was stratified into “before” and “during” COVID-19 subgroups, using March 11, 2020, as the demarcation time point. Women who began their GDM follow-up starting March 11, 2020, and thereafter were allocated to the COVID-19 era, whereas women who delivered before the demarcation point served as the pre–COVID-19 era. The primary outcome was the rate of large-for-gestational-age (LGA) neonates. Secondary outcomes included select maternal and neonatal adverse outcomes. ResultsSeven hundred seventy-five women were included in the analysis, of which 187 (24.13%) were followed during the COVID-19 era and 588 (75.87%) before the COVID-19 era. One hundred seventy-one of the 187 women (91.44%) followed during COVID-19 had at least 1 virtual follow-up visit. No virtual follow-up visits occurred before the COVID-19 era. There was no difference in the rate of LGA neonates between groups on both univariate (5.90% vs 7.30%, p=0.5) and multivariate analyses, controlling for age, ethnicity, parity, body mass index, gestational weight gain, chronic hypertension, smoking, and hypertensive disorders in pregnancy (adjusted odds ratio [aOR] 1.11, 95% confidence interval [CI] 0.49 to 2.51, p=0.80). In the multivariate analysis, there was no difference in composite neonatal outcome between groups (GDM diet: aOR 1.40, 95% CI 0.81 to 2.43, p=0.23; GDM medical treatment: aOR 1.20, 95% CI 0.63 to 2.43, p=0.5). ConclusionsAfter adjusting for differences in baseline variables, the combined virtual mode of care was not associated with a higher rate of LGA neonates or other adverse perinatal outcomes in women with GDM. Larger studies are needed to better understand the specific impact of virtual care on less common outcomes in pregnancies with GDM.

The effect of cognitive behavioral therapy on depression of people with epilepsy

BackgroundDepression, a common mental problem frequently detected in people with epilepsy (PWE), is a major factor that decreases the quality of life of PWE. The cognitive behavioral therapy (CBT) is the most commonly used non-pharmacological treatment for depressive disorders. The CBT for PWE with depression has not yet been studied in Korea. This study aimed to evaluate the effects of the CBT on depression in PWE in Korea. MethodThis study included 16 PWE with depression who received CBT and 30 control PWE with depression who did not receive CBT. The mean number of CBT sessions per patient was 7.2 in the CBT group. The Beck Depression Inventory-II (BDI-II) and Patient Health Questionnaire-9 (PHQ-9) were administered before and after CBT sessions in the CBT group, whereas PHQ-9 was performed at baseline and follow-up in the control group. The difference in PHQ-9 and BDI-II scores were analyzed between the pre- and post-CBT periods in the CBT group. The difference between baseline and follow-up PHQ-9 scores was compared in the control group. ResultsThere was no significant difference in baseline variables between the CBT and control groups. The PHQ-9 score significantly decreased after the CBT sessions in the CBT group (pre-CBT PHQ-9 = 13.56 vs. post-CBT PHQ-9 = 8.56) but it did not change in the control group (Baseline PHQ-9 = 13.83 vs. follow-up PHQ-9 = 14.67). Twelve PWE had undergone four or more CBT sessions with pre-CBT and post-CBT BDI-II. The BDI-II score significantly decreased after CBT sessions (pre-CBT BDI-II = 30.75 vs. post-CBT BDI-II = 21.5). The CBT decreased the sub-field scores of cognitive and physical-emotional factors as well as suicidal ideation, but the score of sleep problems did not significantly improve. The CBT did not significantly change the seizure frequency. ConclusionThe CBT significantly improved depression in Korean PWE. Therefore, it can be considered a treatment tool for depression in PWE. However, a study with more patients and a fixed number of CBT sessions is recommended to generalize this effect.

Outcomes Following Different Thermal Ablation Strategies in Patients with Unresectable Colorectal Liver Metastases.

Background For patients with unresectable colorectal liver metastases (CRLM), clinical guidelines recommend imaging-guided thermal ablation combined with systemic therapy. However, the optimal thermal ablation strategy remains unclear. Purpose To compare long-term outcomes between patients who underwent upfront ablation or delayed ablation for unresectable CRLM. Materials and Methods This retrospective study included patients with unresectable CRLM (three or fewer lesions; diameter, <3 cm) admitted to one of seven hospitals between October 2009 and December 2020. Upfront ablation was performed 2-4 weeks before the start of systemic therapy, and delayed ablation was performed 2-3 months after the start of systemic therapy. Propensity score matching was applied to adjust for differences in baseline variables between groups. Disease-free survival (DFS) was the primary outcome. Overall survival (OS), complications, and adverse events were secondary outcomes. Outcomes were compared between groups by using the log-rank test. Results In total, 255 patients who underwent delayed ablation (mean age, 57 years ± 11 [SD]; 184 men [72%]) and 103 patients who underwent upfront ablation (mean age, 56 years ± 12; 72 men [70%]) were included. After propensity score matching (n = 100 in both groups), the 5-year DFS for patients who underwent upfront ablation was better compared with patients who underwent delayed ablation (36% vs 21%; P = .02). For 5-year OS, no evidence of a difference was observed between ablation strategies (delayed ablation, 59% vs upfront ablation, 64%; P = .49). Additionally, no differences were observed between ablation strategies with respect to the rates of ablative complications (delayed ablation, 6% vs upfront ablation, 5%; P = .76) or drug-related adverse events (delayed and upfront ablation both 9%; P = .99). Conclusion In patients with relatively few (three or fewer) and small (<3 cm) unresectable CRLM, upfront thermal ablation combined with adjuvant systemic therapy led to better DFS compared with delayed ablation. © RSNA, 2023 Supplemental material is available for this article. See also the editorial by Georgiades in this issue.

P191 Efficacy and improvement in patient-reported outcomes at weeks 16 and 52 in ixekizumab treated biological naïve patients with radiographic axial spondyloarthritis achieving clinically important pain at night reduction at week 16: results from COAST-V trial

Abstract Background/Aims Ixekizumab (IXE), a monoclonal antibody that selectively targets interleukin IL-17A, has shown efficacy in patients with radiographic axial spondyloarthritis (r-axSpA). Spinal pain, in particular spinal pain at night (SP-N), is a major contributor to the patient burden of r-axSpA.To assess SP-N improvement in patients up to week (W) 52 and to determine the association of SP-N improvement in patients treated with IXE with other patient-reported outcomes (PROs) at W16 and with reaching ASDAS LDA at W52. Methods The Phase III COAST-V (NCT02696785) trial investigated the efficacy of IXE in 341 patients with r-axSpA and were biological disease-modifying anti-rheumatic drug (bDMARD)-naïve. Patients were randomised to IXE every 2W (IXEQ2W), IXE every 4W (IXEQ4W), adalimumab (ADA) or placebo (PBO) up to W16. Only approved dose IXEQ4W data are presented here. SP-N was measured at each visit using a numeric rating scale (NRS) (0-10). A clinically relevant improvement in SP-N was defined as &amp;gt; 2 point improvement from baseline. Differences in baseline variables between those achieving versus not achieving &amp;gt;2 improvement in SP-N were tested using Fisher’s exact test (binary variables) and analysis of variance (ANOVA; continuous variables). Associations of SP-N improvement with PROs (BASFI, Fatigue Severity NRS, Jenkins Sleep Evaluation Questionnaire (JSEQ), SF-36 PCS) at W16, and ASDAS LDA at W52 were tested using analysis of covariance (ANCOVA; continuous variables) and logistic regression (binary variables). Missing values were imputed using non-responder imputation (NRI), and modified baseline observation carried forward. Results A greater proportion of patients achieved &amp;gt;2 improvement in SP-N with IXE treatment compared to PBO at W16 (63.0% vs. 32.2%, p &amp;lt; 0.001) and improvement was sustained up to W52. Of the 81 patients originally randomised to IXE, those achieving &amp;gt;2 improvement in SP-N (63%) at W16 were younger, more frequently positive for HLA-B27 and had higher disease activity at baseline compared to those that did not achieve &amp;gt;2 improvement. Achieving &amp;gt;2 improvement in SP-N was associated with improvement in PROs including BASFI, Fatigue Severity, JSEQ and SF-36 PCS at W16 and with achieving ASDAS&amp;lt;2.1 at W52 compared to those not achieving &amp;gt;2 improvement in SP-N. Conclusion IXE improved SP-N for patients with r-axSpA not previously treated with bDMARDs. Improvements in SP-N were associated with improvements in disease activity, function, fatigue, and quality of life. Disclosure S. Ramiro: Consultancies; S. Ramiro has served as a speaker and/or consultant for: AbbVie, Eli Lilly and Company, Merck Sharp &amp; Dohme, Novartis, Pfizer, Sanofi, and UCB Pharma. Grants/research support; S. Ramiro has received grant and/or research support from: AbbVie, Galapagos NV, Novartis, Pfizer, and UCB Pharma. C. Lukas: Consultancies; C. Lukas has served as a speaker and/or consultant for: AbbVie, Amgen, Bristol Myers Squibb, Chugai Pharmaceutical, Eli Lilly and Company, Galapagos NV, Merck Sharp &amp; Dohme, Novartis, Pfizer, Roche. Grants/research support; C. Lukas has received grant and/or research support from: Eli Lilly and Company, Novartis, Pfizer, and Roche. M. Nissen: Consultancies; M. J. Nissen has served as a speaker and/or consultant for: AbbVie, Celgene, Eli Lilly and Company, Janssen, Novartis, and Pfizer. Y. Schymura: Shareholder/stock ownership; Y. Schymura is a shareholder and employee of: Eli Lilly and Company. K. Ng: Shareholder/stock ownership; K. Ng is a shareholder and employee of: Eli Lilly and Company. A. Bradley: Shareholder/stock ownership; A. Bradley was an employee of: Eli Lilly and Company at the time of the study. G. Doridot: Shareholder/stock ownership; G. Doridot is a shareholder and employee of: Eli Lilly and Company. S. Liu-Leage: Shareholder/stock ownership; S. Liu-Leage is a shareholder and employee of: Eli Lilly and Company. A. Chan: Consultancies; A. Chan has served as a speaker and/or consultant for: AbbVie, Amgen, Biogen, Celgene, Eli Lilly and Company, Janssen, Novartis, and UCB Pharma. C. Wei: Grants/research support; J. C.-C. Wei has received consulting fees and/or grant and/or research support from: AbbVie, Bristol Myers Squibb, Celgene, Chugai Pharmaceutical, Eisai, Eli Lilly and Company, Janssen, Novartis, Pfizer, Sanofi-Aventis, TSH Biopharm, and UCB Pharma.

Fast systematic geriatric assessment in acute heart failure patients admitted in Cardiology

BackgroundHeart failure prevalence is increasing in elder adults. These patients usually present geriatric syndromes, especially frailty. The effect of frailty on heart failure is under discussion but there are few data about the clinical characterization of frail patients who are admitted for acute heart failure decompensation. ObjectiveThe purpose of this study was to study the differences in clinical baseline variables and geriatric scales between frail and non-frail patients admitted to the Cardiology unit via the Emergency Department for acute heart failure. MethodsWe enrolled all patients with acute heart failure who were admitted to the Cardiology unit from the Emergency Department of our hospital from July 2020 through May 2021. A multidimensional and comprehensive geriatric assessment was performed at the moment of admission. We studied differences in baseline variables and geriatric scales according to the frailty status determined by the FRAIL scale. ResultsA total of 202 patients were included. In the whole population, 68 (33.7%) patients presented frailty defined by a FRAIL score ≥ 3. The frail patients were older (80±9 vs. 69±12 years; p<0.001), and had a worse quality of life (58.31±12.18 vs.39.26±13.71 points; p<0.001) according to the Minnesota scale, presented high comorbidity (47 (69.1%) vs. 67 (50.4%) patients; p = 0.011) defined as ≥3 points according to the Charlson scale and were more dependent (40 (58.8%) vs. 25 (18.8%) patients; p<0.001) according to the Barthel scale. The frail patients presented higher MAGGIC risk scores (24.09±4.99 vs. 18.89±6.26; p<0.001). Despite this adverse profile, the treatments prescribed during the admission and at the hospital discharge were similar. ConclusionsThe prevalence of geriatric syndromes, especially frailty, is very high in patients admitted for acute heart failure. Frail patients with acute heart failure had an adverse clinical profile with more prevalence of concomitant geriatric syndromes. Therefore, we consider that a geriatric assessment should be performed during the admission of acute heart failure patients to improve care and attention.

DOES PATIENT AGE INFLUENCE FUNCTIONAL OUTCOMES TWO YEARS AFTER PERIACETABULAR OSTEOTOMY?

The influence of patient age on functional outcomes after periacetabular osteotomy (PAO) for acetabular dysplasia remains unclear, with previous studies utilising scores developed for older, arthritic patients. The purpose of this study is to assess the influence of patient age on International Hip Outcome Tool (iHOT-12) scores, two years after PAO.Eighty-six patients (72 female, 14 male; mean age 26.9 years) who underwent PAO by a single surgeon and had completed a minimum of two years follow up were identified. Patients were categorised into three groups according to age at the time of surgery: adolescent (11-20 years; n=29), young adult (21–30 years; n=29), and mature (≥31 years; n=28). The three groups were compared with respect to baseline variables and functional outcomes (iHOT-12, EQ-5D quality of life score, University of California Los Angeles (UCLA) activity score, pain visual analogue score (VAS)). Multivariate regression was undertaken to assess for independent predictors of two-year iHOT-12 score.The adolescent group demonstrated a lower BMI (p=0.004) while the mature group had a greater American Society of Anaesthesiology (ASA) score (p=0.049). There were otherwise no significant differences in baseline variables between the three groups (all p&gt;0.05).The three groups demonstrated significant post-operative improvements across all functional outcome measures. There were no significant differences in two-year iHOT-12, EQ-5D, UCLA score or pain VAS between the three groups (all p&gt;0.05). Regression modelling found that patient age at the time of surgery did not have an independent effect on two-year iHOT-12 score (p=0.878).We found that patient age at the time of surgery did not influence functional outcomes two years after PAO. Our results suggest that patient age should not be considered in isolation as an indication or contraindication for PAO.

DOES SOCIOECONOMIC DEPRIVATION INFLUENCE PATIENT OUTCOMES AFTER PERIACETABULAR OSTEOTOMY?

Higher levels of socioeconomic deprivation have been associated with worse health outcomes. The influence of socioeconomic deprivation on patients undergoing periacetabular osteotomy (PAO) has not previously been investigated.A total of 217 patients (171 female, 46 male; median age 23.4 years) who underwent PAO by a single surgeon were identified. Patients were categorised into three groups according to their New Zealand Deprivation (NZDep) Index: minimal deprivation (NZDep Index 1–3, n=89), moderate deprivation (NZDep Index 4-6, n=94), and maximal deprivation (NZDep Index 7-10, n=34). The three groups were compared with respect to baseline variables, surgical details, complications, and pre-operative and two-year post-operative functional scores (including International Hip Outcome Tool (iHOT-12), EQ-5D quality of life score, and University of California Los Angeles (UCLA) activity score). Multivariate regression was undertaken to assess for the effect of NZDep Index on patient outcomes.Patients in the maximal deprivation group were more likely to be Māori (p&lt;0.001) and have surgery in a public rather than a private hospital (p=0.004), while the minimal deprivation group demonstrated a lower BMI (p=0.005). There were otherwise no other significant differences in baseline variables, surgical details, complications, nor pre-operative or two-year post-operative functional scores between the three groups (all p&gt;0.05). Multivariate analysis identified a higher NZDep Index to be independently predictive of a lower pre-operative UCLA activity score (p=0.014) and a higher two-year iHOT-12 score (p&lt;0.001).Our results demonstrate an inequality in access to PAO, with patients exposed to higher levels of socioeconomic deprivation under-represented in our study population. When provided access to PAO, these vulnerable patients achieve significant functional improvement at least as great as patients with less socioeconomic deprivation. Initiatives to improve access to hip preservation care in socioeconomically deprived populations appear warranted.

Sex and Gender Differences in Stroke and Their Practical Implications in Acute Care.

There are several controversies regarding the role of sex and gender in the pathophysiology and management of acute stroke. Assessing the role of sex, i.e., biological/pathophysiological factors, and gender, i.e., sociocultural factors, in isolation is often not possible since they are closely intertwined with each other. To complicate matters even more, the functional baseline status of women and men at the time of their first stroke is substantially different, whereby women have, on average, a poorer reported/ascertained baseline function compared to men. These differences in baseline variables account for a large part of the differences in post-stroke outcomes between women and men. Adjusting for these baseline differences is difficult, and in many cases, residual confounding cannot be excluded. Despite these obstacles, a better understanding of how patient sex and gender differences influence acute stroke and stroke care pathways is crucial to avoid biases and allow us to provide the best possible care for all acute stroke patients. Disregarding patient sex and gender on one hand and ignoring potential confounding factors in sex- and gender-stratified analyses on the other hand, may cause researchers to come to erroneous conclusions and physicians to provide suboptimal care. This review outlines sex- and gender-related factors in key aspects of acute stroke, including acute stroke epidemiology, diagnosis, access to care, treatment outcomes, and post-acute care. We also attempt to outline knowledge gaps, which deserve to be studied in further detail, and practical implications for physicians treating acute stroke patients in their daily practice.

Effectiveness of Yiqi Fumai lyophilized injection for acute heart failure: Rationale and design of the AUGUST-AHF cohort study.

The effect of Yiqi Fumai lyophilized injection (YQFM) on acute heart failure (AHF) patients has been evaluated in a large sample, randomized, controlled trial (AUGUST-AHF RCT study). However, restrictive eligibility criteria from a randomized clinical trial may raise concerns about the generalizability of the results to under-represented groups or complex patients with multimorbidity. Therefore, we intend to conduct the AUGUST-AHF cohort study which aims to assess the effectiveness of YQFM in patients with AHF in a real-world setting and compare the results with AUGUST-AHF RCT study. This prospective, multicenter cohort study will be conducted at 50 secondary and tertiary hospitals in China and comprise 1,200 patients with AHF. The participants will be followed for up to at least 180 days. The primary outcome is a composite of 90-day all-cause mortality or readmission for heart failure. The secondary outcomes include length of hospital stay, cardiac-specific death, MACE, NYHA cardiac function classification. Cox proportional-hazards regression models will be used to estimate the association between YQFM use and the primary outcome. The primary analysis will use propensity-score matching methods to balance the differences in baseline variables between treatment cohorts. Approval for the study has been obtained from the Ethical Committee of Dongzhimen Hospital (approval No. 2022DZMEC-327-02) and registered at ClinicalTrials.gov (NCT05586048). The study results will be published in peer-reviewed journals and presented at scientific conferences.

Family history of cancer is a prognostic factor for better survival in operable esophageal squamous cell carcinoma: A propensity score matching analysis.

Patients with a family history of cancer, especially digestive tract cancer and esophageal cancer, a family history of cancer in the first degree, and more than one relative affected by cancer were associated with favorable survival when compared to those without a family history of cancer. A family history of cancer is a favorable independent prognostic factor in ESCC. Patients with a family history of cancer, especially digestive tract cancer and esophageal cancer, a family history of cancer in the first degree, and more than one relative affected by cancer were associated with favorable survival when compared to those without a family history of cancer. A family history of cancer (FH) is closely associated with the risk and survival of many cancers. However, the effect of FH on the prognosis of patients with esophageal squamous cell carcinoma (ESCC) remains unclear. We performed a large cohort study in the Chinese population to obtain insight into the prognostic value of FH in patients with operable ESCC. A total of 1,322 consecutive patients with thoracic ESCC who had undergone esophagectomy between January 1997 and December 2013 were included. The FH group included patients with any degree of FH, while the non-FH group included patients without any degree of FH. In total, 215 patients with FH and 215 without FH were matched using the propensity score matching analysis method to adjust for differences in baseline variables between the two groups. The impact of FH on disease-free survival (DFS) and overall survival (OS) was estimated using the Kaplan-Meier method and Cox's proportional hazards models. Before matching, 280 (21.2%) patients were included in the FH group and 1,042 (78.8%) in the non-FH group. FH was associated with early pathological T stage (p = 0.001), lymph node-negative status (p = 0.022), and early pathological stage (p = 0.006). After matching, FH was an independent prognostic factor for DFS and OS in ESCC patients. Patients with FH had 35% lower risk of disease progression (hazard ratio [HR] = 0.65, 95% CI: 0.51-0.84, p = 0.001) and 34% lower risk of death (HR = 0.66, 95% CI: 0.51-0.86, p = 0.002) than those without FH. Patients with a family history of digestive tract cancer (FH-DC), a family history of esophageal cancer (FH-EC), FH in first-degree relatives (FH-FD), and more than one relative affected by cancer were associated with favorable DFS and OS as compared to those without FH. FH is a favorable independent prognostic factor in ESCC. Patients with FH, especially those with FH-DC, FH-EC, FH-FD, and more than one relative affected by cancer, had improved survival.

Abstract 12677: Intensive Cardiac Rehabilitation Outcomes in Patients With Heart Transplant

INTRODUCTION Heart Transplant (HT) is gold standard for patients with Heart failure (HF) with end stage disease, however it requires ideal post-surgical recovery which includes medications &amp; Cardiac Rehabilitation (CR). Clinical trials have shown that CR can reduce morbidity &amp; mortality, increase exercise tolerance and reduce psychological symptoms in patients with HT. Intensive Cardiac rehabilitation (ICR) has proven benefits for patients with HF but the outcomes of ICR in patients with HT are unknown. Methods: Retrospective cohort study of 1413 patients from Jan-2016 to Dec-2020. ICR sessions consists of 4-hours two times per week for 9-weeks of lifestyle modification aiming at high fiber low fat diet, peer support, exercise and stress reduction.Patients were divided into two groups: 18 patients in HT group and 1395 patients in HF group. Primary endpoints were change in body mass index (BMI), exercise minutes per week (EMW) and depression scores (CESD). Secondary endpoints includes change in blood pressure (BP), cholesterol (chol), low density lipoprotein (ldl), high density lipoprotein (hdl), triglycerides (tgl) and health status (SF-36 physical &amp; mental composite scores). T test was used to compare variables between two groups. Linear regression was used to adjust for difference in baseline variables. Results: Table 1 explains baseline characteristics and demographics of both groups. Table 2 shows outcomes of both groups pre and post-ICR. Conclusions: Significant Improvement in ICR outcomes were achieved for both groups. There is no difference among groups when improvements were compared with each other except for chol which has improved more in patients with HF.

Final benefit of primary percutaneous coronary intervention for ST-elevation myocardial infarction in older patients: long-term results of arandomised trial.

Although the short-term benefit of primary percutaneous coronary intervention (PCI) in elderly patients with ST-elevation myocardial infarction (STEMI) has been demonstrated, the final long-term survival benefit is as yet unknown. To assess the final survival benefit of primary PCI as compared to thrombolytic therapy in patients over 75years of age. Patients > 75years with STEMI were randomised to either primary PCI or thrombolysis. Long-term data on survival were available for all patients. Atotal of 46patients were randomised to primary PCI, 41to thrombolysis. There were no significant differences in baseline variables. After amaximum of 20years' follow-up, all patients had passed away. The patients randomised to thrombolysis died after amean follow-up duration of 5.2years (SD 4.9) compared to 6.7years (SD 4.8) in patients randomised to primary PCI (p = 0.15). Thus, the mean final survival benefit of primary PCI was 1.5years. The final survival benefit of primary PCI as compared to thrombolysis in elderly patients with STEMI is 1.5years and their life expectancy increases by 28.8%.

Serum Uromodulin and All-Cause Mortality in Peritoneal Dialysis Patients: A Chinese Cohort Study

Serum Uromodulin and All-Cause Mortality in Peritoneal Dialysis Patients: A Chinese Cohort Study

Coronary Obstruction After Transcatheter Aortic Valve Replacement: From Risk Prediction to Prevention

Coronary Obstruction After Transcatheter Aortic Valve Replacement: From Risk Prediction to Prevention

MO802: Genetics Plays a Limited Role in ESA-Hyporesponsiveness and Haemoglobin Outcomes in End-Stage Renal Disease Patients on Haemodialysis

Abstract BACKGROUND AND AIMS Patients with end-stage renal disease on haemodialysis (HD) frequently have resistance or hyporesponsiveness (hypoR) to erythropoiesis-stimulating agents (ESAs) and are also often iron deficient. Despite evidence of increased comorbidities impacting outcomes such as treatment response and achieving targeted haemoglobin (Hb) and iron levels, there is substantial residual variability in these outcomes that remains unexplained. The ability to identify higher-risk sub-populations may provide additional opportunities to intervene. Genetic loci associated with Hb concentration have been identified in genome-wide association studies. Genetic risk scores (GRS) that provide a means to aggregate the health-related risk of multiple genetic alleles into a single number for risk assessment have been validated using these variants. We evaluated if GRS associated with Hb concentration, in addition to clinical factors, improves prediction of ESA hypoR, Hb and iron outcomes better than either one used alone. METHOD A collaborative, non-interventional study between GlaxoSmithKline and DaVita enrolled 3192 African American (AA) and European American (EA) HD patients. Patient demographics, laboratory and vital measurements, concomitant medications, and comorbidity records were drawn from Electronic Health Records, with patient blood samples obtained for genetic analysis. We created GRS for transethnic and euro-centric populations for Hb concentrations from the literature, and a GRS specific to EGLN1/2/3 genes. ESA hypoR status, iron replete status, and time weighted Hb concentration were evaluated as outcomes. ESA hypoR for epoetin alfa was defined by an erythropoietin resistance index ≥ 2.0 U/kg/wk/g/L [intravenous (IV)] or ≥ 1.33 U/kg/wk/g/L [subcutaneous (SC)], or dose ≥ 450 U/kg/wk (IV) or ≥ 300 U/kg/wk (SC). Iron replete was defined as a ferritin ≥ 100 ng/mL and transferrin saturation ≥ 20%. Heritability was estimated using genome complex trait analysis (GCTA). All analyses were performed individually for each population (AA and EA). Significant P-value threshold was 0.0167 (0.05/3 main effects). RESULTS None of the genetic risk scores tested had any clinically meaningful association with outcomes. Though the GRS specific to EGLN1/2/3 was significantly associated with Hb concentration (P &amp;lt; .01) in the AA population, the Beta squared effect size (ES) was very low (ES = 0.005). GCTA analyses were inconclusive with moderate heritability (h2 &amp;gt;8%) and high standard error (&amp;gt;30%), suggesting high variability in heritability estimates for outcomes. Ignoring GRS, several baseline measurements were significantly associated with outcomes. Baseline Hb was consistently and significantly associated with ESA hypoR and Hb concentration in both AA and EA populations, while significantly associated with iron replete status in only the EA population (P &amp;lt; .0001). Other variables such as age and baseline albumin were significantly associated with ESA hypoR and iron replete status, but only in either the EA or AA population (Table). Significant differences were also observed in baseline characteristics between the EA and AA patients. AA patients were 8 years younger and on HD for 2 years longer (P &amp;lt; .0001) at enrolment compared with EA patients. Baseline ferritin, creatinine, albumin and hypertensive status were also significantly different at baseline (P &amp;lt; .01). CONCLUSION There was limited utility for genetics in predicting ESA hypoR, haemoglobin and iron outcomes in HD patients in AA and EA populations. GCTA analyses were inconclusive, suggesting high variability in heritability estimates. Significant differences in baseline variables between the AA and EA populations that were also significantly associated with ESA hypoR, haemoglobin and iron outcomes suggested that population-level baseline differences must be considered when identifying at-risk sub-populations.

De Novo Donor Specific Antibody Expression in Lung Transplant Recipients with EVLP-Conditioned Allografts

<h3>Purpose</h3> Recipients of marginal donor lungs conditioned by ex-vivo lung perfusion (EVLP) have non-inferior short and long-term outcomes compared to recipients of non-EVLP lungs. Whether EVLP increases the risk of de novo donor specific anti-HLA antibodies (dnDSA) early post-transplant has not been reported. <h3>Methods</h3> We performed a single-center, retrospective analysis between 10/2019- 7/2021. EVLP was performed at a specialized center (Lung Bioengineering). Post-lung transplant (LTx) management was similar in both groups. DSA was measured at 1-month post-LTx using a Luminex single-antigen assay. Differences in baseline variables between groups were analyzed using Fisher's exact, Wilcoxon rank-sum or Kruskal-Wallis tests. Multiple logistic regression analysis was then performed to assess the relationship between EVLP and dnDSA, including covariates that were significant on univariate assessment at p<0.2. <h3>Results</h3> DSA were measured in 76 consecutive LTx recipients (LTRs) in the study period; 12 received EVLP-conditioned lungs and 64 did not. Baseline demographics were similar between cohorts except for total ischemic times (Fig 1). At 1-month post-LTx 3 patients (25%) in the EVLP cohort developed class II DSA (all DQ). In the non-EVLP cohort 6 patients (9%) developed class I DSA antibodies (all B) and 11 patients (17%) developed class II DSA (8 with DQ and 3 with DR). When adjusting for gram negative infection and transfused red blood cells, there was no difference in dnDNA incidence between cohorts (Fig 2). <h3>Conclusion</h3> The use of EVLP-conditioned donor lungs is not associated with increased incidence of dnDSA early post-LTx.

The effect of tamoxifen on the lipid profile in women: A systematic review and meta-analysis of randomized controlled trials.

The effect of tamoxifen administration on serum lipids in females remains unclear. The studies which have explored this topic have produced conflicting results, probably due to discrepancies in the length of the intervention, differences in baseline variables or other factors. To answer this research question, we decided to conduct this systematic review and meta-analysis to assess the effects of tamoxifen on the lipid profile in women. A comprehensive search was conducted in Web of Science, Scopus, PubMed/Medline and Embase, from the inception of these databases up to June 2021. We used a random effects meta-analysis to generate the combined results. The overall findings were generated from 18 eligible trials. As compared to placebo, tamoxifen led to a notable reduction of the total cholesterol (TC) (WMD: -23.03mg/dL, 95% CI: -25.94 to -20.12, P˂0.001), and the low-density lipoprotein-cholesterol (LDL-C) (WMD: -18.68mg/dL, 95% CI: -24.31 to -13.04, P˂0.001). However, tamoxifen did not alter triglycerides (TG) concentrations (WMD: +1.06mg/dL, 95% CI: -11.08 to 13.20, P=0.864) significantly. A pronounced reduction of the high-density lipoprotein-cholesterol (HDLC) was noted in the RCTs with a duration of ≤52weeks (WMD: -2.06mg/dL) and when tamoxifen was administered in participants with a BMI ≥25kg/m2 (WMD: -1.42mg/dL). Notable reductions in TC (WMD: -23.57mg/dL) and LDL-C (WMD: -19.21mg/dL) was detected when the dose of tamoxifen was ≥20mg/day. Moreover, a significant reduction of TC (WMD: -20.23mg/dL) and LDL-C (WMD: -24.13mg/dL) was observed in the RCTs with a duration of ≤52weeks. Tamoxifen can alter the lipid profile in females, particularly by decreasing TC, LDL-C and HDLC. Tamoxifen can further reduce TC and LDL-C if the dose of administration is ≥20mg/day, the treatment duration is ≤52weeks and if it prescribed in subjects with dyslipidemia.

Clinical significance and outcomes of bilateral and unilateral recurrent laryngeal nerve lymph node dissection in esophageal squamous cell carcinoma: A large-scale retrospective cohort study.

BackgroundThe survival benefits of recurrent laryngeal nerve lymph node dissection (RLNLD) in esophageal squamous cell carcinoma (ESCC) are still under debate, and the prognostic value of unilateral RLNLD has been rarely studied. Therefore, the aim of the present study was to investigate the clinical significance and outcomes of RLNLD in ESCC in a large‐scale cohort study, to shed light on the outcomes of unilateral RLNLD, and to identify the factors that affect the prognostic outcome of RLNLD.MethodsWe retrospectively reviewed 1153 patients with thoracic ESCC who underwent right thoracotomy with lymphadenectomy. The impact of RLNLD on disease‐free survival (DFS) and overall survival (OS) was estimated using the Kaplan–Meier method and Cox proportional hazard models. Inverse probability of treatment weighting (IPTW) was performed to adjust for differences in baseline variables in pairwise comparisons. Subgroup analysis of survival and postoperative complications was conducted for selective RLNLD.ResultsRLN lymph node (LN) metastasis was independently associated with tumor location and most other LN station metastases. RLNLD was an independent prognostic factor for DFS and OS. Both patients who underwent unilateral and bilateral RLNLD had significantly better DFS and OS than the non‐RLNLD patients. Furthermore, pairwise comparisons with IPTW confirmed these results, and we found that patients who underwent bilateral RLNLD had better survival than those who underwent unilateral RLNLD. However, subgroup analysis showed that there was no survival benefit and higher morbidity after bilateral RLNLD for patients with cancer in the lower thoracic esophagus, and elderly and female patients.ConclusionRLN LN metastasis is very frequent in ESCC, and both unilateral and bilateral RLNLD have considerable survival benefits. Selective RLNLD with better survival and lower morbidity was recommend for some defined subgroups.

Abstract 138: Thrombus Composition Is Associated With First Pass Recanalization

Introduction: Our objective is to identify thrombus composition associated with first pass recanalization (FPR) in mechanical thrombectomy (MT). Methods: Intracranial thrombi obtained in MT were divided in two equal parts. One part was analyzed with anatomopathological studies to quantify fibrin, red-blood cell( Hematoxilin &amp; Eosin) and platelets( cd61 Immunohistochemical staining ) , the other part was analyzed by flow cytometry to quantify leukocyte populations (granulocytes, lymphocytes and monocytes) and their relative proportions . FPR were defined as ≥ mTICI 2b after first pass in MT. Thrombi composition, baseline variables (demographics, previos use of antiplatelets or anticoagulants, blood pressure and blood glucose at hospital arrival ) etiology, intravenous fibrinolysis, ASPECTS score and first attempt thrombectomy devices: direct aspiration, stent retriever or combinations were compared between FPR and Non-FPR groups. Results: Fifty percent (38/76) of the cases analyzed obtained FPR. There were no differences in baseline variables , etiology, Aspects score, previous use of fibrinolysis or type of device used for MT. The thrombi obtained with FPR presented higher proportion of red blood cells (33.64% vs 18.16% p = 0.048) and lymphocytes (10.07% vs 4.43% p = 0.042) and lower proportion of platelets (61, 48% vs 67.26% p = 0.042) in comparison to non-FPR group. The proportion of platelets was an independent marker of FPR (OR 0.97; CI 0.95-0.99). There was an inverse correlation between the proportion of platelets and lymphocytes (rho -0.44, p &lt;0.001). Conclusion: Platelets proportion in intracranial thrombus is an independent marker of first pass recanalization. Inverse relationship between lymphocytes and platelets may be a target for future reperfusion treatments