Significant Ef Research Articles

Clinical outcomes with perioperative nivolumab (NIVO) by nodal status among patients (pts) with stage III resectable NSCLC: Results from the phase 3 CheckMate 77T study.

LBA8007 Background: In CheckMate 77T, perioperative NIVO showed statistically significant EFS improvement vs neoadjuvant (neoadj) chemo followed by adjuvant (adj) placebo (PBO) in pts with stage (stg) II or III resectable NSCLC. We report clinical outcomes by baseline (BL) stg III N2 status, a subgroup with poor historical 5 y survival (26%–36%; Goldstraw J Thorac Oncol 2016). Methods: Adults with resectable stg IIA–IIIB (N2; AJCC v8) NSCLC were randomized to neoadj NIVO 360 mg Q3W + chemo (4 cycles [cyc]) followed by adj NIVO 480 mg Q4W (13 cyc) or neoadj PBO Q3W + chemo (4 cyc) followed by adj PBO Q4W (13 cyc). Primary endpoint: EFS per BICR. Exploratory analysis: efficacy and safety in pts with BL clinical stg III N2 or non N2 disease (dz). Results: BL characteristics were generally similar between pts with stg III N2 (NIVO, 91; PBO, 90) and non N2 dz (55; 57), and between treatment (tx) arms, except a higher percent of pts with N2 dz had NSQ histology and ECOG PS 0 (both arms). Pts with N2 dz had improved EFS with NIVO vs PBO (HR 0.46; 1 y EFS 70% vs 45%) and higher pCR (22.0% vs 5.6%; median f/u 25.4 mo; Table). Pts with non N2 also had EFS benefit with NIVO vs PBO (HR 0.60; 1 y EFS 74% vs 62%) and higher pCR (25.5% vs 5.3%; Table). Surgical feasibility was similar between pts with N2 and non N2 dz and numerically higher with NIVO vs PBO. Of pts with N2 dz, 77% (NIVO) vs 73% (PBO) had definitive surgery (pneumonectomy 1% vs 14%; R0 resection 86% vs 86%); of pts with non N2 dz, 82% vs 79% had definitive surgery (pneumonectomy 13% vs 9%; R0 resection 84% vs 87%). Tumor downstaging postsurgery was seen in most pts with stg III dz and was deeper with NIVO vs PBO: 61% vs 50% (N2; 33% vs 14% to ypT0), 87% vs 76% (non N2; 27% vs 11% to ypT0). Of all pts with stg III dz, nodal downstaging postsurgery was 52% (NIVO) vs 45% (PBO); 46% vs 36% to ypN0. Grade 3–4 TRAEs occurred in 34% (NIVO) and 26% (PBO) of pts with N2; 29% and 21% of pts with non N2 dz. Conclusions: In this exploratory analysis, perioperative NIVO showed clinical benefit vs PBO in pts with stg III NSCLC, regardless of N2 status. Over half of pts with stg III dz had nodal downstaging with NIVO; majority downstaged to ypN0. This first comprehensive analysis by nodal status among pts with stg III dz from a global phase 3 study of perioperative immunotherapy further supports perioperative NIVO as a tx option for pts with resectable NSCLC. Clinical trial information: NCT04025879 . [Table: see text]

A systematic review and meta-analysis on utilizing anti-CD19 chimeric antigen receptor T-cell therapy as a second-line treatment for relapsed and refractory diffuse large B-cell lymphoma.

Inconsistent results observed in recent phase III trials assessing chimeric antigenic receptor T (CAR-T) cell therapy as a second-line treatment compared to standard of care (SOC) in patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) prompted a meta-analysis to assess the effectiveness of CAR-T cell therapy in this setting. Random-effects meta-analysis was conducted to pool effect estimates for comparison between CAR-T cell therapy and SOC. Mixed treatment comparisons were made using a frequentist network meta-analysis approach. Meta-analysis of three trials with 865 patients showed significant improvement in event-free survival (EFS: HR: 0.51; 95% CI: 0.27-0.97; I2: 92%), progression-free survival (PFS: HR: 0.47; 95% CI: 0.37-0.60; I2: 0%) with CAR-T cell therapy compared to SOC. Although there was a signal of potential overall survival (OS) improvement with CAR-T cell therapy, the difference was not statistically significant between the two groups (HR 0.76; 95% CI: 0.56 to 1.03; I2: 29%). Mixed treatment comparisons showed significant EFS benefit with liso-cel (HR: 0.37; 95% CI: 0.22-0.61) and axi-cel (HR: 0.42; 95% CI: 0.29-0.61) compared to tisa-cel. CAR-T cell therapy, as a second-line treatment, appears to be effective in achieving higher response rates and delaying the disease progression compared to SOC in R/R DLBCL.

Fat beyond muscle: Assessing epimuscular fat of the lumbar spine and its association with vertebral level, demographics, BMI, and low back pain

IntroductionEpimuscular fat (EF) has rarely been studied in the context of low back pain (LBP). Research questionThis study aims to assess the presence and extent of EF in the lumbar muscles and its association with vertebral level in patients with low back disorders and to explore correlations between EF, demographics, BMI, and LBP. Material and methodsT2 axial MRIs from L1 to L5 were manually segmented to analyze the cross-sectional area (CSA) of EF (mm2), and fat infiltration (FI,%) of 40 patients (23 females, 17 males; mean age:65.9 years) with lumbar degenerative pathologies awaiting a surgical procedure. COMI, LBP, demographic, and clinical data were extracted from the institutional registry. Statistical analyses included Wilcoxon and Mann-Whitney tests for differences in EF between sides and sexes, the Friedman test for EF size differences among lumbar levels, and Spearman’s correlation for associations, adjusted for BMI, age, and sex. ResultsEF was found in 77.5% of subjects at L1, 92.5% at L2, 100% at L3 and L4, and 95.0% at L5. EF was significantly larger at L4 (253.1 ± 183.6 mm2) and L5 (220.2 ± 194.9 mm2) than at L1 (36.1 ± 37.8 mm2) and L2 (72.2 ± 84.4 mm2). No significant EF differences were found between sides and sexes. EF correlated strongly with BMI (rs = 0.65,p < 0.001) and moderately with FI (rs = 0.31,p = 0.04), though its correlation with FI was not significant after adjustment. EF did not correlate with COMI scores but correlated with LBP in the adjusted analysis (rs:0.31,p = 0.04). Discussion and conclusionEF is present across all lumbar levels, with higher concentrations at L4 and L5, and a significant correlation between EF and LBP intensity was observed. The present findings are limited to a specific subset of patients with lumbar degenerative disorders who are awaiting surgical procedures.

IDH1/2-Mutated B-ALL Presents As Burkitt's Leukemia/Lymphoma-like ALL

Background: Burkitt leukemia/lymphoma (BL) is a highly aggressive hematological malignancy, which is characterized by the FAB L3 morphology of monotonous medium-sized cells containing abundant basophilic cytoplasm and lipid vacuoles, with mature B cell immunophenotype. Interestingly, some B-cell acute lymphoblastic leukemia (B-ALL) could resemble BL in morphology, but with immature B-cell immunophenotype. In this study, we aimed to explore the molecular and clinical characteristics of these “BL-like B-ALL” patients. Methods: We analyzed the molecular and clinical characteristics of B-ALL patients in the First Affiliated Hospital of Zhejiang University. RNA-seq analysis of BL-like B-ALL was performed to study the mechanisms of L3 morphology. Results: We analyzed the population of patients with B-ALL of FAB L3 morphology, among 68 patients, 17 cases with IDH1 mutation and 1 case with IDH2 mutation. In subgroups of 260 B-ALL patients, OS and EFS were significant shorter in BL-like patients compared with others (median 567 days vs not reached, median 238 days vs 566 days; p=0.0024, 0.0122, respectively). Gene set enrichment analysis (GSEA) analysis of RNA-seq with 27 cases of BL-like B-ALL patients revealed significant enrichment in fatty acid metabolism pathway, compared with 203 B-ALL patients in TARGET database. Therefore, we measured levels of serum triglyceride (TG), total cholesterol (TC), low-density lipoprotein-cholesterol (LDL-C), high-density lipoprotein-cholesterol (HDL-C) in 251 B-ALL patients at diagnosis, among which TG and TC levels of 62 BL-like B-ALL patients were significant higher (p=0.0006, p=0.0040), while LDL-C and HDL-C levels showed no significant differences between two groups. Furthermore, we tracked a IDH1-mutated BL-like patient and found that IDH1 mutation and L3 morphology were not detected in remission, but both reappeared with disease relapse. Meanwhile, IDH1/2-mutated B-ALL patients in our center had significant shorter EFS compared with other B-ALL patients (p=0.0087). Conclusion: IDH1/2-mutated B-ALL presents as Burkitt's leukemia/lymphoma-like ALL. BL-like ALL patients have higher levels of lipid metabolism with worse prognosis.

Long-term outcomes of neoadjuvant immunotherapy plus chemotherapy in patients with early-stage triple-negative breast cancer: an extracted individual patient data and trial-level meta-analysis.

Neoadjuvant immunotherapy (nIO) has emerged as a treatment option for stage II-III triple-negative breast cancer (TNBC). While randomised clinical trials (RCTs) demonstrated pathological complete response rate benefit to nIO added to chemotherapy, additional data on long-term outcomes is warranted. We performed this analysis to evaluate long-term efficacy outcomes of nIO in TNBC. We searched databases for RCTs evaluating nIO in early-stage TNBC. A meta-analysis of extracted individual patient data (EIPD) was performed to evaluate EFS and OS, with data from reported Kaplan-Meier plots. Additionally, we conducted a trial-level meta-analysis using fixed and random effects models. The literature search resulted in four included RCTs with available EFS or OS (KEYNOTE-522, IMpassion031, I-SPY2 and GeparNuevo). EIPD showed that the addition of nIO to chemotherapy provides statistically significant benefits in EFS (HR 0.62, 0.50-0.76; p < 0.001) and OS (HR 0.62, 0.46-0.82, p < 0.001). Number needed to treat to avoid one EFS or OS event in 4 years was 9 and 14, respectively. Trial-level meta-analysis yielded similar results (EFS: HR 0.64, 0.51-0.79; OS: 0.57, 0.37-0.89). Results show that nIO combined with chemotherapy can provide significant EFS and OS benefits, supporting its use as standard treatment for early-stage TNBC.

Abstract 18997: Management of Immune Checkpoint Inhibitor Mediated Myocarditis

Clinical Presentation: A 52-year-old female with metastatic Stage IVB (T4N3M1c) lung adenocarcinoma presented with worsening dyspnea. She had just completed her 3 rd round of carboplatin/pemetrexed/pembrolizumab/MK-5890 chemotherapy. Upon examination she was noted to be hypertensive and tachycardic with an elevated high-sensitivity troponin T. ECG showed sinus tachycardia, left axis deviation, and flattened T waves in lead V5 and V6. In the ED, she subsequently developed supraventricular tachycardia and was admitted to the ICU. TTE demonstrated moderately reduced EF of 30-35%. TTE also identified hypokinesis in the basal to mid anterior and lateral walls and apical akinesis. Initial CMR showed an EF of 31% with akinesis of the mid and apical anterior, septal and inferior wall. Given the clinical and imaging findings, she was diagnosed with myopericarditis secondary to pembrolizumab and started on 1 mg/kg methylprednisolone taper for 60 days. Repeat CMR after completion of steroid taper showed evidence of weighted T2 edema in myocardium and pericardium. Late gadolinium enhancement (LGE) in inferior and lateral epicardium and adjacent pericardium as well as patchy LGE throughout the myocardium with significant EF improvement (57%) (Figure 1A-B). In our patient, multi-modality imaging was used to confirm the diagnosis and monitor treatment response. Discussion: Immune checkpoint inhibitors (ICI) are a novel class of immunotherapies used in certain malignancies. Initial treatment of myocarditis consists of cessation of further ICI and administration of corticosteroids. Additionally, symptomatic myocarditis treatment should be started. Reinitiating ICI therapy should ultimately be done with shared decision making.

Abstract 12764: Reduced EF With Mavacamten Initiation in a Patient With Atrial Fibrillation: A Case Report

Description of Case: A 55-year-old male with a history of paroxysmal atrial fibrillation (AF) and hypertrophic cardiomyopathy (HCM) diagnosed three years prior at an outside institution presented to clinic with exertional dyspnea. Baseline TTE confirmed HCM demonstrating an EF of 69%, mitral systolic anterior motion (SAM), left ventricular outflow tract (LVOT) obstruction, and a peak gradient exceeding 100 mmHg. Initiation of mavacamten 5mg resulted in symptom improvement and a one-month follow-up TTE demonstrating a reduced peak gradient of 74 mmHg and normal EF. However, two months after initiation the patient returned with AF with rapid ventricular response (RVR) and TTE showed a newly reduced EF of 21%. Mavacamten was stopped while home metoprolol XL was increased from 100 to 150 mg daily for rate optimization. Holter monitoring showed a 100% Afib burden with an average heart rate of 108 beats per minute. Stopping mavacamten for four weeks resulted in worsening exertional dyspnea but restoration of EF to 52% on TTE. Mavacamten was reinstated at a lower dose of 2.5 mg, resulting in symptom improvement. Monthly TTE exams over four months consistently demonstrated a normal EF without LVOT obstruction at rest. Discussion: Mavacamten, a promising drug used to treat obstructive HCM, modulates myosin to reduce myosin-actin cross-bridging. Reduction in contractility improves mitral SAM, LVOT obstruction, and symptoms. However, because mavacamten is a negative inotrope it can also precipitate reductions in EF. Generally, patients have a mild drop in EF (~5 points) after initiation. However, our patient had a significant EF drop of over 25 points likely due to both mavacamten initiation and new AF with RVR reducing systolic function. Discontinuation of mavacamten for four weeks and rate optimization likely restored EF. Dose reduced re-initiation of mavacamten resulted in long-term normal EF and improvement in symptoms. This case highlights the need for close monitoring and individualized mavacamten treatment plans. Further research is warranted to understand the interplay and long term outcomes of tachyarrhythmias and mavacamten use.

Evaluation of Wastewater Coagulation/Flocculation with Chitosan from Shrimp Exoskeletons Waste and Aluminum Sulfate

Intensive use of water, growing cities, and lack of wastewater treatment are some factors increasing hydric stress worldwide. Coagulation/flocculation is one of the preferred treatments for wastewater. However, aluminum salts are traditionally used in this process. This coagulant has a high environmental footprint and residual aluminum in wastewater is a public health concern. The preparation and use of chitosan as a coagulant aid in coagulation/flocculation with aluminum sulfate were investigated. The ef fect of the order of addition of coagulants (aluminum sulfate followed by chitosan, or chitosan followed by aluminum sulfate), dose of the coagulants, pH, and slow mixing velocity for flocculation were studied. It was found that the removal of total suspended solids (TSS) with aluminum sulfate was relatively unaf fected by pH (aluminum sulfate dose of 100 mg L-1 at pH of 5 units achieved 94% removal of TSS and at pH of 8.2 units 89% removal of TSS), whereas with chitosan was highly af fected (chitosan dose of 180 mg L-1 at pH of 4 units achieved 96% removal of TSS and at pH of 8.2 units 25% removal of TSS). In the coagulation/flocculation experiments where both coagulants were used, it was found that the order of coagulant addition and pH of wastewater have a statistically significant ef fect (P-value &lt; 0.05) on the removal of TSS. Higher removal of TSS was achieved when aluminum sulfate was added followed by chitosan at a wastewater pH of 5 units. Chitosan can be ef fectively used to reduce the use of aluminum salts in wastewater treatment. However, it is necessary to optimize the preparation of this coagulant and investigate other factors, such as variation in the wastewater quality, that can af fect the robustness of the process.

PENGARUH STRATEGI PEMASARAN VIRAL YANG MEMPENGARUHI NIAT BELI BAGI KONSUMEN SKINTIFIC

This research is conducted the ef ect of viral marketing strategies on Skintific's purchase intention for consumers:the value of fish as mediation. This research used non-probability sampling through convenience sampling to obtain228 respondents who are Skintific skincare users. Data collection was carried out online by distributingquestionnaires via Google Forms. Data was processed using the Partial Least Square Structural Equation Modeling(PLS-SEM) method with SmartPLS 4.0 software. The results showed that viral marketing strategies in the form ofEntertainment, Informativeness and Source Credibility had a positive and significant ef ect on Advertisement Value,while there was a negative and insignificant ef ect of viral marketing strategies on Advertisement Value. Besidesthat, there is a positive and significant influence from Entertainment and Informativeness on Purchase Intention.And Advertisement Value mediates the two relationships between Entertainment and Purchase Intention Skintificpositively and significantly, Advertisement Value also mediates the two relationships between Source Credibility andPurchase Intention Skintific positively and significantly, Advertisement Value also mediates both relationshipsbetween Irritation and Purchase Intention Skintific negatively and not significant, and Advertisement Value alsomediates the relationship between Source Credibility and Purchase Intention Skintific in a positive and significantway.

PENGARUH MOTIVASI DAN KECERDASAN EMOSIONAL TERHADAP HASIL BELAJAR MATEMATIKA SISWA SMK BERYAYASAN BUDDHIS SE-TANGERANG

The purpose of this research was to test empirically the ef ect of learning motivation, emotionalintelligence, learning motivation and emotional intelligence simultaneously on the Mathematical learningoutcome of Buddhist-based vocational high school students in Tangerang Raya. This study uses quantitativemethods, with the sample size was determined using the Slovin formula and obtained a sample of 210, 11th grade students of the Buddhist Foundation Vocational School in Tangerang Raya. Test the validity of theinstrument using Pearson Product Moment and test the reliability using Alpha Cronbach. Data analysisused multiple linear regression. The results showed that learning motivation and emotional intelligence hada significant ef ect on mathematics learning outcome for class XI SMK students as evidenced by asignificance value of 0.000&lt;0.05. Learning motivation and emotional intelligence simultaneously af ect themathematics learning outcome of class XI SMK students as evidenced by a significance value of 0.000 &lt;0.05.

The Moderating Role of Natural Resources Between Fiscal Decentralization, Government Internal Audit, Law Enforcement and Corruption: Evidence from Indonesian Local Government

This research is a quantitative study which aims to examine the level of corruption in the Indo- nesian local government with its influencing determinants, namely fiscal decentralization, gov- ernment internal audit, and law enforcement and natural resources as moderating variables. The population in this study is the district and city governments in Indonesia. The sample in this study consisted of 81 district governments and 33 city governments based on the purposive sampling method with the criteria of district and city governments having permanent legal force corruption cases in 2019. Testing the hypothesis in this study using Moderated Regression Analysis (MRA) with the SPSS Version 24 program. The results showed that fiscal decentralization had a significant effect on the level of corruption, government internal audit and law enforcement had no significant ef- fect on the level of corruption, natural resources had a significant effect on moderating the effect of fiscal decentralization on the level of corruption. This research was conducted to examine and analyze the factors that can influence the level of corruption in local governments. In addition, with this research, it can be seen how local governments carry out their government affairs and the role of local governments in suppressing the level of corruption.

Assessment of Comorbidities and Their Association with Outcomes in Adults with Acute Lymphoblastic Leukemia (ALL)Using Various Comorbidity-Based Scoring Systems

Background: Outcomes of adults with ALL has remained poor as compared to pediatric ALL. While biological characteristics of the disease can increase the risk of poor treatment responses and resistance, age and concurrent comorbidities limit patient's tolerability to aggressive therapies and predispose to treatment related adverse effects, ultimately affecting survival. Despite similar chronological age, patients vary widely with respect to comorbidities and other aspects of health such that routine performance assessment scales such as Eastern Cooperative Oncology Group (ECOG) or Karnofsky Performance Scale (KPS) may not be accurate in assessing their fitness for therapy. Several measures such as Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI), Charlson Comorbidity Index (CCI), Cumulative Illness Rating Scale-Geriatric (CIRS-G) and Adult Comorbidity Evaluation-27 (ACE-27) have been reported in the literature to assess comorbidities in patients receiving intensive treatments, but their utility when it comes specifically to ALL patients is unknown, given the lack of studies assessing role comorbidities in ALL. Methods: We conducted a retrospective single center analysis of adults (age >=18) with ALL to assess the effect of comorbid conditions using available scales and determined their association with outcomes. Patients with a diagnosis of ALL (B/T-cell) who received first line therapy between 2009-2021 were included. Key exclusion criteria were patients with relapsed/refractory ALL and with incomplete follow-up. Comorbid conditions prior to first line therapy were calculated using four scales - HCT-CI, CCI, CIRS-G and ACE-27. Baseline demographic and disease characteristics, first line treatment, response, outcomes were collected using chart review. Descriptive statistics, logistic regression, Cox Proportional Hazards regression method was used for analysis. Concordance (C-statistic) and 95% confidence interval was reported for each model for comparison. A receiver operating characteristic (ROC) curve was also created for each outcome to compare the performance of base and comorbidity score models. Results: A total of 201 patients were included for analysis. Median age was 54(range 39-65), 53% were males, 82% were Caucasians, 8.5% Hispanics. 86% had B-ALL (32% were Philadelphia chromosome positive), 83% received intensive therapy. Median OS was 3.8 years (3.7-not reached) and Event free survival was 2.0(1.5,3.3) for the entire patient population. Patients were categorized in 0(22%), 1 (19%),2(13%) and 3+(46%) per HCT-CI, 0(32%), 1(23%),2(12%) and 3+(33%) per CCI. In CIRS-G scale patients were categorized in to 2 groups of <6 and >=6(51.5% vs 48.5%). In ACE-27 scale there were 4 categories (none(0),mild(1) moderate(2) and severe(3)) with 19%, 41%, 21% and 18% in each group consecutively. All four comorbidity scales were able to predict overall and event-free survival with statistical significance. Patients with HCT-CI category of <=1 had statistically significant OS and EFS advantage when compared to patients with a score of >=2 (Not reached vs 3.1-3.7 yrs for OS, 2.4-5.2 vs 1.4-1.6 yrs for EFS). Patients with CCI category 0 (not reached, 3.4) had better median OS and PFS than categories 1,2 (3.7 years OS, 1.8-3.1 yrs PFS) and 3+ (3.4, 1.4 yrs). CIRS-G category of <6 score had better median OS and PFS (not reached) than 6+ category (3.0 yrs). In ACE-27 scale, 0 and 1 categories had better OS and PFS (not reached and 3.4 yrs, not reached and 2.3 yrs vs 3.0-3.2 and 1.4 yrs) than moderate and severe (2,3) categories. Though all scales could predict OS and EFS, the overall survival model with CIRS-G scale had a significantly higher C-statistic compared to the base model than other scales. The HCT-CI and CIRS scores were each significant in their models for complete remission, but there were no significant differences between c-statistics among any of the CR models. None of the comorbidity scores were significant in predicting 90-day readmission or ED visit. Conclusions: Comorbidities as assessed by HCT-CI, CCI, ACE-27 or CIRS-G were significantly associated with survival in adults with ALL. Incorporation of these formal methods of comorbidity assessment in clinical practice is needed to assess ALL patients at baseline and tailor therapy accordingly. Prospective studies to validate and identify the optimal comorbidity determination scale in ALL is needed. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

The Effect of Financial Ratios on Financial Distress in Matahari Department Store Companies listed on the Indonesia Stock Exchange for the 2016-2020 period

The purpose of this study was to determine the ef ect of liquidity, leverage, profitability and activity on financial distress at Matahari Department Store companies listed on the Indonesia Stock Exchange (IDX) for the 2016-2020 period. This research was conducted descriptively and quantitatively. This research was processed using SPSS IBM 25. This research was conducted by analyzing financial statements, based on the application using the Z-score method. Descriptive data analysis techniques, classical assumption test, multiple linear regression analysis, and hypothesis testing. The results of this study are partially liquidity and leverage ratios have a negative and insignificant ef ect on financial distress, profitability ratios have a positive and insignificant ef ect on financial distress, while the activity ratio has a positive and significant ef ect on financial distress

Predictors and Prognostic Impact of Left Ventricular Ejection Fraction Recovery after Impella-Supported Percutaneous Coronary Interventions in Acute Myocardial Infarction.

Aim: The aim of our study is to assess the predictors and the prognostic role of left ventricle ejection fraction (LVEF) recovery after Impella-supported percutaneous coronary intervention (PCI) in patients presenting with acute myocardial infarction (AMI). Methods: This retrospective, observational study included patients admitted for AMI who underwent Impella-supported PCI in two Italian high-volume cardiac catheterization laboratories. Only patients who underwent an echocardiographic assessment of left ventricle ejection fraction (LVEF) before the procedure (acute LVEF) and during follow-up (follow-up LVEF) were included in the present analysis. Patients with a baseline LVEF ≥40% were excluded from the present analysis. LVEF recovery was calculated as the difference between follow-up LVEF and acute LVEF. A delta ≥5% was considered significant and was used to define the responder group. Results: From April 2007 to December 2020, 64 consecutive patients were included in our study. A total of 55 patients (86%) received hemodynamic support with Impella 2.5, and 9 patients (14%) with Impella CP. Median LVEF at follow-up was significantly higher compared to baseline (36% (30–42) vs. 30% (24–33), p < 0.001). Based on LVEF recovery, 37 patients (57.8%) were deemed responders. According to multivariate analysis, complete functional revascularization was an independent predictor of a significant EF recovery (OR: 0.159; 95% CI: 0.038–0.668; p = 0.012). At three-year follow-up, lack of LVEF recovery was the only predictor of mortality (HR: 5.315; 95% CI: 1.100–25.676; p = 0.038). Conclusions: Functional complete revascularization is an independent predictor of the recovery of LVEF in patients presenting with AMI who underwent Impella-supported PCI. The recovery of LV function is associated with improved prognosis and could be used to stratify the risk of future events at long-term follow-up.

Quantification of methylation-specific cardiomyocyte cell-free DNA as an early marker of cardiotoxicity in patients with breast cancer receiving anthracyclines and trastuzumab.

12090 Background: There is currently no way to reliably predict which patients undergoing therapy for breast cancer will develop cardiotoxicity. An early biomarker of cardiotoxicity could provide opportunity for intervention prior to the appearance of gross abnormalities on echocardiogram (ECHO). A droplet digital PCR (ddPCR) assay for circulating cell-free DNA (cfDNA) can detect cfDNA released from dying cardiomyocytes with high sensitivity by differentiating cfDNA of cardiomyocyte origin based on the pattern of methylation specific to the cell type. Circulating cfDNA of cardiac origin was tested as an early biomarker of toxicity in patients who underwent breast cancer treatment while closely monitoring cardiac function in a prospective clinical trial. Methods: A cardiomyocyte methylation-specific quantitative ddPCR assay was tested in plasma samples from 29 patients who were part of a larger prospectively enrolled cohort of women who received anthracyclines and trastuzumab for HER2-positive breast cancer. Blood samples were tested from prior to doxorubicin and cyclophosphamide (AC) chemotherapy, two months later after completing AC and prior to trastuzumab, and every 3 months to 12 months post-treatment. Patients were assessed for clinical cardiotoxicity, defined as heart failure (NYHA class III/IV) or significant EF decline (&gt; = 10% to below 53% or &gt; = 16%) until completion of cancer therapy. The maximum detected level of cardiac cfDNA (copies per 500 µL plasma) was compared between those who experienced cardiotoxicity and those who did not by two-sided T-tests. Results are reported as mean +/- standard deviation. Results: At baseline, cardiac cfDNA levels were low (mean 1.1 +/- 2.4 copies). Of 29 patients, five developed clinical cardiotoxicity. The maximum number of cfDNA copies at any time point was elevated in patients who experienced cardiotoxicity compared to those who did not (mean of 20.6 +/- 7.3 copies versus 9.3 +/- 9.8 copies, p = 0.0216). Of the patients with cardiotoxicity, elevated cfDNA of greater than 10 copies was detected an average of 3.6 +/- 2.5 months prior to the onset of clinical cardiotoxicity. Conclusions: Methylation specific cardiac cfDNA shows promise as an early indicator of cardiotoxicity in patients treated with anthracyclines in this pilot study. A previously reported analysis in the levels of seven other biomarkers including high-sensitivity troponin I and NT-proBNP pre- versus post-treatment in the full cohort of 80 patients did not show any statistically significant associations with the development of cardiotoxicity, suggesting that cardiac cfDNA may be uniquely informative. Clinical trial information: NCT02177175.

FLUCTUATIONS OF LEFT VENTRICULAR LVEF IN IHD PATIENTS

Ischemic heart disease (IHD) is the world’s major cause of death. It presents clinically as myocardial infarction and ischemic cardiomyopathy and is also known as coronary artery disease. To define LVEF percentage in CAD patients. This cross-sectional study was done retrospectively by collecting data from the database of “Scientific Research Institute of Cardiology and Internal Diseases” Almaty, Kazakhstan during 2020. IHD was confirmed in clinical, angiographic and other lab findings with TTE used for detection of LVEF. A sequential non-random sampling technique used SPSS for statistical analysis. Conventional echocardiography showed that there were significant differences in LVEF percentage in patients based on age and gender. The number of female and male patients who have preserved LVEF was 66.4% and 54.7% accordingly, 21.6% of females and 22.1% of males had Mid-range LVEF and 12.1% of females and 23.3% of males had decreased LVEF (P-value = 0.001). The mean of LVEF was (55.8% ±11.79). Maximum and minimum of EF were 84%, 12% respectively. We discovered that EF was moderately lower in male patients than in females in the sample. When compared to patients without a history of IHD, those with IHD history showed more significant EF deterioration. IHD patients with low EF appeared to be at high risk of Hypertension and infarction with decreased HDLc.

Pengaruh Kondisi Keuangan Perusahaan, Debt Default, Dan Opini Audit Tahun Sebelumnya Terhadap Penerimaan Opini Audit Going Concern (Studi Kasus Pada Perusahaan Sektor Aneka Industri Yang Tercatat Di Bursa Efek Indonesia Tahun 2015 - 2019)

The influence of Financial Condition, Debt Defualt, and Audit Opinions of Prior Year of the acceptance of Going Concern Opinios in the miscellaneous sectors listed at Indonesia Stock Exchange in the year 2015 - 2019. South Tangerang. Under the guidance of Mrs. Silvi Reni Cusyana S.E., M.Ak. This study aims to examine the influence of financial condition, debt default, and audit opinions prior year in the miscellaneous sectors of the acceptance going concern opinion. This study using secondary data sources with two data collection techniques, using financial document and literature review. The result of this study regarding financial condition has a significant ef ect to acceptance of going concern audit opinions. Debt default and audit opinions of prior year do not have significant ef ect to acceptance of going concern audit opinions in miscellaneous sectors listed at Indonesia stock exchange in the year 2015 - 2019

ANALISIS FAKTOR YANG MEMPENGARUHI PERPINDAHAN MEREK (BRAND SWITCHING) PENGGUNA JARINGAN OPERATOR TRI KE OPERATOR LAIN DI MASA PEMBELAJARAN ONLINE SAAT PANDEMI COVID -19

This researchs purpose to know some factors that influence brand switching Tri operator user to another operator and get result from the pre-survey include the ef ect of product atribute, variety seeking, promotion and price on brand switching. Thisresearch obtained via by questionnaire to 96 respondents which become Tri operator user to students at the As- syafi'iyah Islamic University with population 3.850. Analyst data method that used is regression analysis, correlation, coef icient of determination and hypothesis test. Based on analyst data result, partially product attributes give positive and significant ef ect on brand switching. Variety seeking give positive and significant ef ect on brand switching. Promotion give ositive and significant ef ect on brand switching. Price give positive and significant ef ect on brand switching.

Outcome Transcatether Patent Ductus Arteriosus Closure in Children

Objective: To evaluated outcome transcatether PDA closure and differentiated LVEDD, EF pre and posttranscatether PDA closure. Methods: Hospital registry was reviewed and data about patients characteristics,PDA size, device occluder and outcomes were retrieved. An descriptive analytic study with a retrospectivedesign was conducted on all medical records of PDA pediatric patients who received definitive transcatheterPDA closure at IDIK and were treated at the Department of Child Health, Dr. Soetomo Hosptal from January2017 until December 2019. The variables studied are: outcome transcatether PDA closure (complete closure,residual shunt, emboli device, obstruction pulmonaly artery, obstruction Aorta descendent, hemolysis,LVEDD and EF). Post catheterization included a follow up of immediately, 1 day, 1 month, 3 months, 6months, and 12 months after catheterization. The data were processed and statistical comparative tests werecarried out. Results: There were 101 subjects, of whom were 33 males, who underwent transcatether closureof PDA during study periode. The diameter PDA ranged from 1-7.5 mm, with median 3.4 mm. Medianage 4.3 years (4 months-18 years), median body weight was 15.4 (5 – 45) kg. Device could be deployed inall patients, in which ADO I 65%, ADO II 15%, Nit Occlude 2% and MFO 19%. Immediately Completeclosure was achieved in most patiens (92,1%) and small residual shunt (7,9%), no major complicationduring or after procedure. Most patient were discharged from hospital at 3 day after procedure. LVEDD andEF was decreased after intervention transcatether closure (P &lt;0.05). There were no significant differences inLVEDD and EF transcatether based on closured method and sex. Conclusion: All patients showed completeclosure during followed up. Transcatheter closure of PDA is safe and effective with shorter hospitalizationand minimally complications.

Localized osteosarcoma analysis of very poor responders subgroup (Huvos I).

e22010 Background: Osteosarcoma is a malignant primitive bone tumor whose prognosis is not changed since 4 decades, after the introduction of neoadjuvant chemotherapy with Methotrexate, Cisplatin, Doxorubicine and Ifosfamide. Histologic response to preoperative chemotherapy is a significant prognostic factor. Huvos I (necrosis ≤ 50%) has worst prognosis . Previous studies reported a 3 years EFS of this Huvos I patients around 25% (Tsuda Y,2020). In order to evaluate if survival has changed in recent years in this unfavourable prognostic group we evaluated the outcome of osteosarcoma patients with Huvos I. Methods: from our Pathology archieves we retrieved all cases of localized osteosarcoma treated at Rizzoli with neoadjuvant chemotherapy who reported an histologic necrosis below or equal to 50% (Huvos I grade) after preoperative chemotherapy MAP (Ethical C. Approval 917/2020/Oss/IOR). Results: from 2003 to 2019 we had 70 cases of localized osteosarcoma with Huvos I necrosis after neoadjuvant chemotherapy ( MAP in 66 and MAPI in 4) evaluable. Median age 21,5 (3-70); M:F = 44:26. 10/70 had axial localization vs extremity(60), subhistotype distribution:46 osteoblastic,11 chondroblastic, 7 fibroblastic, 5 teleangectatic, one not classified. In 24 cases PgP was available(14 PgP positive). With a median follow up of 86.7 ms (IQR 41-136) 43/70 had already relapsed. The median EFS was 25 ms (95% CI 15-42) and the 3 yrs EFS was 40.6% (95% CI 29-52). The 3 yrs overall survival was 80% (95%CI 68-88) and median OS was not reached. Axial tumor site was associated with significant inferior EFS (P = .004). Conclusions: these data confirm the poor prognosis of patients with necrosis ≤50% and the need of new drugs to improve their survival in this sub-group.