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Lipoprotein(a) and the Effect of Alirocumab on Revascularization Following Acute Coronary Syndrome

Steg, P Gabriel; Szarek, Michael; Valgimigli, Marco; Islam, Shahidul; Zeiher, Andreas M; Bhatt, Deepak L; Bittner, Vera A; Chiang, Chern-En; Diaz, Rafael; Goodman, Shaun G; Gotcheva, Nina; Harrington, Robert A; Jukema, J Wouter; Kim, Hyo-Soo; Kim, Sang-Hyun; Morais, Joao; Pordy, Robert; Scemama, Michel; White, Harvey D; Schwartz, Gregory G
BACKGROUND:Many patients require revascularization after an index acute coronary syndrome (ACS). Lipoprotein(a) is thought to play a pathogenic role in atherothrombosis. In ODYSSEY OUTCOMES, alirocumab reduced major adverse cardiovascular events after ACS, with greater reduction among those with higher lipoprotein(a) levels. We explored whether risk of revascularization after ACS was modified by the level of lipoprotein(a) and treatment with alirocumab or placebo. METHODS:ODYSSEY OUTCOMES compared alirocumab with placebo in 18 924 patients with ACS and elevated atherogenic lipoproteins despite optimized statin treatment. In this post hoc analysis, treatment effects are summarized by competing-risks proportional hazard models. RESULTS:<0.001). Alirocumab produced the greatest reduction of coronary revascularization in patients with baseline lipoprotein(a) in the top quartile (≥59.6 mg/dL) (HR, 0.69 [95% CI, 0.57-0.84]), but no apparent reduction in the bottom quartile (HR, 1.00 [95% CI, 0.82-1.22]). Findings were similar for the effect of alirocumab on any revascularization. CONCLUSIONS:Alirocumab reduced revascularization after ACS. The risk of revascularization and reduction in that risk with alirocumab were greatest in patients with elevated lipoprotein(a) at baseline. (ODYSSEY OUTCOMES NCT01663402).
PMID: 37116789
ISSN: 1916-7075
CID: 5465622

Low dose vs high dose tocilizumab in COVID-19 patients with hypoxemic respiratory failure

Chung, Juri; Brosnahan, Shari B; Islam, Shahidul; Altshuler, Diana; Spiegler, Peter; Li, Wai Kin; Wang, Wai Man; Chen, Xian Jie Cindy
PURPOSE/OBJECTIVE:Tocilizumab has been shown to decrease mortality when used concomitantly with steroids in COVID-19 with 8 mg/kg (max 800 mg) being the standard dose. Our study sought to assess whether a low dose (400 mg) shows similar benefit compared to a high dose for COVID patients concurrently on the same median dose of steroids. MATERIALS/METHODS/METHODS:A retrospective, multihospital observational study of COVID-19 patients who received tocilizumab in conjunction with steroids between March 2020 and August 2021 was conducted. RESULTS:A total of 407 patients were analyzed with low dose group being significantly more ill at baseline as a higher percentage of patients received vasopressors, were admitted to the ICU and on mechanical ventilation. In the propensity-matched analysis, both groups receiving a median dexamethasone equivalent dose of 10 mg showed no difference in 28-day mortality (p = 0.613). The high dose group had a higher rate of fungal and viral infections. CONCLUSION/CONCLUSIONS:Compared to low dose tocilizumab, the high dose did not provide additional efficacy and mortality benefit but resulted in higher fungal and viral infections. This study illustrates that low dose tocilizumab can be an alternative to high dose during a drug shortage of tocilizumab without compensating for efficacy and safety, conserving resources for more patients.
PMID: 37043893
ISSN: 1557-8615
CID: 5464172

Proportion of Malignancy and Evaluation of Sonographic Features of Thyroid Nodules Classified As Highly Suspicious Using ACR TI-RADS Criteria

Hussain, Najia; Goldstein, Michael B; Zakher, Mariam; Katz, Douglas S; Brandler, Tamar C; Islam, Shahidul; Rothberger, Gary D
OBJECTIVES/OBJECTIVE:The reported malignancy rate of highly suspicious thyroid nodules based on the ACR TI-RADS criteria (TI-RADS category 5 [TR5]) varies widely. The objective of our study was to determine the rate of malignancy of TR5 nodules at our institution. We also aimed to determine the predictive values of individual sonographic features, as well as the correlation of total points assigned to a nodule and rate of malignancy. METHODS:Our single-institution retrospective study evaluated 450 TR5 nodules that had cytology results available, in 399 patients over a 1-year period. Sonographic features and total TI-RADS points were determined by the interpreting radiologist. Statistical analyses included logistic regression models to find factors associated with increased odds of malignancy, and computing sensitivity, specificity, positive and negative predictive values of various individual sonographic features. RESULTS:Of the 450 nodules, 95 (21.1%, 95% exact confidence interval 17.4-25.2%) were malignant. Each additional TI-RADS point increased the odds of malignancy (adjusted odds ratio 1.35, 95% confidence interval 1.13-1.60, P < .001). "Very hypoechoic" was the sonographic feature with the highest specificity and positive predictive value for malignancy (95.5 and 44.8%, respectively), while "punctate echogenic foci" had the lowest positive predictive value (20.0%). CONCLUSIONS:The rate of malignancy of TR5 nodules at our institution was 21.1%, which is lower than other malignancy rates reported in the literature. The total number of points assigned on the basis of the TI-RADS criteria was positively associated with malignancy, which indicates that TR5 should be viewed as a spectrum of risk.
PMID: 36106704
ISSN: 1550-9613
CID: 5336322


Coltrane, M; Nieves, S; Wang, S; Islam, S
INTRODUCTION: In 2017, the American Society for Parenteral and Enteral Nutrition (ASPEN) sought to define treatment areas in which nutrition support provided significant clinical or cost improvement. In 2020, these findings published in the Journal of Enteral and Parenteral Nutrition (JPEN), found an estimated annual savings of $580 million when patients received appropriate nutrition support. In acute pancreatitis (AP), an evaluated treatment area, early enteral nutrition (EN) was associated with decreased multiorgan failure and mortality compared to delayed EN. Our goal is to assess institutional adherence to nutrition support recommendations as per ASPEN guidelines in patients diagnosed with AP.
METHOD(S): This study is a multicenter, retrospective chart review. The patient population included adult patients (age > 18 years) hospitalized at NYU Langone Hospitals - Tisch, Brooklyn, and Long Island, with the diagnosis of AP. Our time frame for analysis spanned between September 1st, 2019 and September 1st, 2021. Patients admitted for less than 48 hours were excluded. The study population was generated through the reporting function within EPIC, our institution's electronic medical record system. Per institutional protocol, our project was deemed a quality improvement, and therefore, exempt of institutional review board (IRB) review. The prevalence of the adherence was computed using the Clopper-Pearson method. Data was summarized using descriptive statistics.
RESULT(S): Based on ASPEN guidelines, 2 out of 89 (2.2%) patients were adherent (95% CI: 0.27%, 7.9%.)
CONCLUSION(S): Based on ASPEN guidelines, 2.2% of identified patients were adherent. The study was limited due to sample size and incomplete documentation. A larger sample would allow for better assessment of adherence as well as a more thorough evaluation of patient outcomes
ISSN: 1530-0293
CID: 5513692


Wang, W M; Chen, X J; Chung, J; Kin, Li W; Islam, S; Altshuler, D; Spiegler, P; Brosnahan, S
INTRODUCTION: Tocilizumab has been shown to decrease mortality when used concomitantly with steroids in COVID-19. Tocilizumab dose of 8 mg/kg (max: 800 mg), stemmed from the RECOVERY trial, has been the standard dose for COVID. Due to a drug shortage of tocilizumab, our study seeks to assess whether low dose (400 mg) shows similar benefit compared to high dose for COVID patients concurrently on same median dose of steroids.
METHOD(S): This was a retrospective observational study of COVID-19 patients who received tocilizumab in conjunction with steroids. Between March 2020 and August 2021, adult patients with positive COVID-19 PCR, hypoxic respiratory failure defined as FiO2>70%, and received a dose of tocilizumab in conjunction with steroids were included. Patients were excluded if they have died within 24 hours of treatment initiation. Primary outcome was 28-day mortality and secondary outcomes included biomarker improvement and relative risk of infection. Propensity matched analysis between groups was performed.
RESULT(S): A total of 407 patients met the study criteria and were analyzed. The low dose and high dose tocilizumab group had 222 and 185 patients respectively. Gender and age were similar between groups and all patients received steroids. The low dose group was significantly more ill at baseline as a higher percentage of patients received vasopressors, were admitted to the ICU and on mechanical ventilation. In the propensity-matched analysis of 56 patients in each group, with a median dose of steroid of 10 mg in both groups showed no difference in 28 day mortality (HR 0.82 [95% CI: 0.41-1.67]; p=0.6138). A greater decrease to normalization of CRP (p< 0.0001) and downtrend of ferritin (p=0.503) was observed in the high dose group at day 14. The high dose group trended a higher rate of fungal and viral infections.
CONCLUSION(S): Compared to low dose tocilizumab, high dose did not provide additional efficacy and mortality benefit but resulted in uptrend of fungal and viral infections. While a greater decrease in CRP was seen in the high dose group, it did not translate into lower mortality. This study illustrates that low dose tocilizumab can be an alternative to high dose during a drug shortage of tocilizumab without compensating for efficacy and safety, conserving resources for more patients
ISSN: 1530-0293
CID: 5513732

Machine Learning Approach to Predict In-Hospital Mortality in Patients Admitted for Peripheral Artery Disease in the United States

Zhang, Donglan; Li, Yike; Kalbaugh, Corey Andrew; Shi, Lu; Divers, Jasmin; Islam, Shahidul; Annex, Brian H
Background Peripheral artery disease (PAD) affects >10 million people in the United States. PAD is associated with poor outcomes, including premature death. Machine learning (ML) has been increasingly used on big data to predict clinical outcomes. This study aims to develop ML models to predict in-hospital mortality in patients hospitalized for PAD based on a national database. Methods and Results Inpatient hospitalization data were obtained from the 2016 to 2019 National Inpatient Sample. A total of 150 921 inpatients were identified with a primary diagnosis of PAD and PAD-related procedures using codes of the International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) and International Classification of Diseases, Tenth Revision, Procedure Coding System (ICD-10-PCS). Four ML models, including logistic regression, random forest, light gradient boosting, and extreme gradient boosting models, were trained to predict the risk of in-hospital death based on a selection of variables, including patient characteristics, comorbidities, procedures, and hospital-related factors. In-hospital mortality occurred in 1.8% of patients. The performance of the 4 models was comparable, with the area under the receiver operating characteristic curve ranging from 0.83 to 0.85, sensitivity of 77% to 82%, and specificity of 72% to 75%. These results suggest adequate predictability for clinical decision-making. In all 4 models, the total number of diagnoses and procedures, age, endovascular revascularization procedure, congestive heart failure, diabetes, and diabetes with complications were critical predictors of in-hospital mortality. Conclusions This study demonstrates the feasibility of ML in predicting in-hospital mortality in patients with a primary PAD diagnosis. Findings highlight the potential of ML models in identifying high-risk patients for poor outcomes and guiding personalized intervention.
PMID: 36216437
ISSN: 2047-9980
CID: 5351942

Clinical Outcomes of Children With Extended-spectrum ß -Lactamase Urinary Tract Infection Receiving Discordant Empiric Antibiotic: A Comparative Study of Fever Duration, Length of Stay, and Readmissions

Begaj, Xhesika; Lee, Hannah; Noor, Asif; Fiorito, Theresa; Agarwalla, Vipin; Kambhampati, Ooha; Islam, Shahidul; Krilov, Leonard R
There has been a recent increase in the incidence of urinary tract infections (UTIs) caused by extended spectrum beta-lactamase (ESBL) producing Enterobacteriaceae, which are resistant to third-generation cephalosporins. Our goal was to compare the clinical responses of patients with ESBL UTI and non-ESBL UTI who received empiric third-generation cephalosporins. A retrospective analysis was performed on data collected between June 1, 2013, and June 30, 2017, from children aged 0 days to 19 years old who presented to NYU Langone Long Island Hospital's pediatric ED and/or were admitted with a UTI caused by Enterobacteriaceae. There was no significant difference in median length of fever duration. However, ESBL patients had significantly longer hospital stays, higher 30-day readmission rate, and higher 7-day revisit rate. It is reasonable to maintain an empiric UTI antibiotic choice rather than selecting a broad-spectrum antibiotic, such as carbapenem for children at high risk of ESBL UTI.
PMID: 36199269
ISSN: 1938-2707
CID: 5351642

Utility of Thyroid Function Testing in the Inpatient Setting

Goldstein, Michael; Islam, Shahidul; Piccione, Julie; Migasiuk, Laura; Rothberger, Gary
BACKGROUND:Previous studies have reported low value of ordering inpatient thyroid function tests (TFTs), with few changes in clinical management resulting from these tests. This study was designed to evaluate how often testing TFTs during hospitalization leads to medication initiation or adjustment, and to determine if the frequency of medication initiation or adjustment differs based on the indication for testing. METHODS:This is a retrospective observational study of 2278 patients who had TFTs tested while admitted to an academic hospital during a 5-month period. Indications for ordering TFTs were determined by reviewing clinical documentation, and those with abnormal tests were reviewed to assess whether thyroid medication was initiated or adjusted. RESULTS:The percentage of abnormal TFTs that led to medication initiation or adjustment was 15.1%, 12.2%, and 6.0%, for those tested on the basis of history of functional thyroid disease, suspicion of thyroid dysfunction, and reasons not directly related to thyroid dysfunction, respectively. Overall, 63 patients were started on thyroid medication or had their thyroid medication dose adjusted, which represents 10.1% of those with abnormal TFTs and only 2.8% of those tested. CONCLUSION/CONCLUSIONS:Abnormal TFTs are common, but a disproportionate amount of tests are needed to find a small percentage of clinically significant thyroid dysfunction, of which only a low percentage lead to changes in management. Education on this topic should be provided to inpatient providers to limit thyroid function testing to instances in which they are clinically indicated and abnormal results would lead to changes in management.
PMID: 35793752
ISSN: 1530-891x
CID: 5280442

Coronavirus Disease 2019 and the Injured Patient: A Multicenter Review

Hakmi, Hazim; Islam, Shahidul; Petrone, Patrizio; Sajan, Abin; Baltazar, Gerard; Sohail, Amir H; Goulet, Nicole; Jacquez, Ricardo; Stright, Adam; Velcu, Laura; Divers, Jasmin; Joseph, D'Andrea K
INTRODUCTION/BACKGROUND:Coronavirus disease 2019 (COVID-19) has been shown to affect outcomes among surgical patients. We hypothesized that COVID-19 would be linked to higher mortality and longer length of stay of trauma patients regardless of the injury severity score (ISS). METHODS:We performed a retrospective analysis of trauma registries from two level 1 trauma centers (suburban and urban) from March 1, 2019, to June 30, 2019, and March 1, 2020, to June 30, 2020, comparing baseline characteristics and cumulative adverse events. Data collected included ISS, demographics, and comorbidities. The primary outcome was time from hospitalization to in-hospital death. Outcomes during the height of the first New York COVID-19 wave were also compared with the same time frame in the prior year. Kaplan-Meier method with log-rank test and Cox proportional hazard models were used to compare outcomes. RESULTS:There were 1180 trauma patients admitted during the study period from March 2020 to June 2020. Of these, 596 were never tested for COVID-19 and were excluded from the analysis. A total of 148 COVID+ patients and 436 COVID- patients composed the 2020 cohort for analysis. Compared with the 2019 cohort, the 2020 cohort was older with more associated comorbidities, more adverse events, but lower ISS. Higher rates of historical hypertension, diabetes, neurologic events, and coagulopathy were found among COVID+ patients compared with COVID- patients. D-dimer and ferritin were unreliable indicators of COVID-19 severity; however, C-reactive protein levels were higher in COVID+ relative to COVID- patients. Patients who were COVID+ had a lower median ISS compared with COVID- patients, and COVID+ patients had higher rates of mortality and longer length of stay. CONCLUSIONS:COVID+ trauma patients admitted to our two level 1 trauma centers had increased morbidity and mortality compared with admitted COVID- trauma patients despite age and lower ISS. C-reactive protein may play a role in monitoring COVID-19 activity in trauma patients. A better understanding of the physiological impact of COVID-19 on injured patients warrants further investigation.
PMID: 36084394
ISSN: 1095-8673
CID: 5337332

The incidence of propofol infusion syndrome in critically-ill patients

Li, Wai Kin; Chen, Xian Jie Cindy; Altshuler, Diana; Islam, Shahidul; Spiegler, Peter; Emerson, Liane; Bender, Michael
PURPOSE/OBJECTIVE:PRIS is a potentially fatal syndrome characterized by various clinical symptoms and abnormalities. Experts suggest that propofol treatment duration ≥48 h or dose ≥83 μg/kg/min is associated with developing PRIS. We hypothesized PRIS might be underdiagnosed due to the overlap of PRIS clinical manifestations with critical illnesses. MATERIALS AND METHODS/METHODS:Multihospital, retrospective study of adult patients who received continuous propofol infusion ≥48 h or dose ≥60μg/kg/min for >24 h since admission were assessed for the development of PRIS. RESULTS:The incidence of PRIS was 2.9% with a PRIS-associated mortality rate of 36.8%. In PRIS patients, propofol was administered at a median dose of 36.4 μg/kg/min and over a median duration of 147.0 h. The development of PRIS was observed at a median of 125.0 h post-propofol initiation and a cumulative dose of 276.5 mg/kg. The development of metabolic acidosis (78.9%), cardiac dysfunction (52.6%), hypertriglyceridemia (100%), and rhabdomyolysis (26.3%) were observed in our PRIS patients. CONCLUSION/CONCLUSIONS:PRIS can often be overlooked and underdiagnosed. It is important to monitor for early signs of PRIS in patients who are on prolonged propofol infusion. Prompt recognition and interventions can minimize the dangers resulting from PRIS.
PMID: 35724444
ISSN: 1557-8615
CID: 5281852