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Self-care and patient engagement are important elements of heart failure (HF) care, endorsed in the guidelines. Digital health tools may improve quality of life (QOL) in HF patients by promoting care, knowledge, and engagement. This manuscript describes the rationale and challenges of the design and implementation of a pragmatic randomized controlled trial to evaluate the efficacy of three digital health technologies in improving QOL for patients with HF.We hypothesize that digital health interventions will improve QOL of HF patients through the early detection of warning signs of disease exacerbation, the opportunity of self-tracking symptoms, and the education provided, which enhances patient empowerment.Using a fully electronic enrollment and consent platform, the trial will randomize 200 patients across HF clinics in the Yale New Haven Health system to receive either usual care or one of three digital technologies designed to promote self-management and provide critical data to clinicians. The primary outcome is the change in QOL as assessed by the Kansas City Cardiomyopathy Questionnaire at 3 months.First enrollment occurred in September 2021. Recruitment was anticipated to last 6-8 months and participants were followed for 6 months after randomization. Our recruitment efforts have highlighted the large digital divide in our population of interest.Assessing clinical outcomes, patient usability, and ease of clinical integration of digital technologies will be beneficial in determining the feasibility of the integration of such technologies into the healthcare system.

Ralstonia mannitolilytica is a Gram-negative, nonfermentative, soil bacterium that is reported to cause opportunistic infections in immunocompromised patients in nosocomial settings. After extensive review of literature, it was found that this is second outbreak reported from India. This study is a retrospective analysis of the clinical features, outcome, and source identification of R. mannitolilytica infection outbreak in a hemato-oncology unit of a tertiary care center of North India between February 2020 and March 2020. We report an outbreak of R. mannitolilytica bacteremia (with or without septic shock) in five patients admitted in hemato-oncology unit at a tertiary care institute in North India for 1 month period. Four patients were cured after administration of appropriate antibiotics as per sensitivity reports, while one patient died of septicemia due to delayed diagnosis. Environmental cultures revealed multidose saline bottles used for administration of drugs as the source of outbreak. Following implementation of use of single dose diluents and flushing solutions in patients with central venous catheter, no new case was reported. Clinicians and microbiologists should keep high index of suspicion to identify these organisms as timely diagnosis is the only key to improve outcomes.

This case report describes a patient in their 60s who presented to the emergency department with a 2-week history of shortness of breath and back pain exacerbated that morning.

There is limited evidence on various clinical aspects of SARS-CoV-2 infection in patients with haematological cancers. The risk factors, prognosis, and outcome of patients with haematological cancers with coexistent COVID-19 need to be explored in different subsets of population. A single-institutional prospective observational study was conducted at a tertiary level medical institute in North India. The clinical details of the recruited patients having haematological malignancies and diagnosed with COVID-19 between 15 March 2020 and 31 May 2021 were prospectively collected through the electronic patient database system. The outcomes with respect to 28-day and 56-day mortality and the associated risk factors for prognostication were analysed. Of the 5750 hospital admissions (inpatient and day-care) during the study period, two hundred and forty-two patients (4.2%) were diagnosed with COVID-19. Acute leukaemia was the most common haematological malignancy, seen in 117 (48.3%) patients. Eighty-nine (36.8%) patients had moderate-to-severe COVID-19 while 153 (63.2%) patients presented with mild infection. The 28-day and 56-day mortality rates in our cohort were 13.3% and 19.8% respectively. Amongst the risk factors associated with poor outcome, the severity of COVID-19 (HR = 1.8, 95% CI 1.16-10.35; p = 0.04), presence of secondary infection (HR = 2.1, 95% CI 2.45-21.3; p = 0.023), and need for invasive mechanical ventilation (HR = 2.3, 95% CI 1.8-18.43; p = 0.01) were prognostically significant on multivariate log rank analysis. The risk of SARS-CoV-2 infection does not increase with haematological malignancies; however, the outcome remains poor in patients with severe COVID-19, requirement of invasive mechanical ventilation, and pre-existing bacterial/fungal infection at presentation.

To summarize published literature on the incidence of adverse drug effects (ADEs) associated with guideline-directed medical therapy (GDMT) for patients with heart failure with reduced ejection fraction (HFrEF).Systematic literature review.A systematic literature review was conducted in PubMed, Ovid MEDLINE, and Clinical Key covering January 1990 to December 2018. Key search terms were ADEs for β-blockers (BBs), ACE inhibitors (ACEis), angiotensin receptor blockers (ARBs), mineralocorticoid receptor antagonists (MRAs), and/or angiotensin receptor-neprilysin inhibitors (ARNis) in adult patients (≥ 18 years) with HFrEF.A total of 279 eligible articles were identified, of which 29 reported drug-related adverse effects and were included in this review. Of the 29 studies, 11 examined BBs; 9, MRAs; 6, ARNis; 2, ACEis; and 1, ARBs. The most common reported ADEs across these therapeutic classes included bradycardia, dizziness, hypotension, hyperkalemia, cough, and renal impairment. The incidence of BB-induced bradycardia was 1% to 52% based on 9 studies, and 6 studies described dizziness as a result of BBs and ARNis (15%-43%). Fourteen studies reported induced hypotension (1.4%-63%); 13 studies, hyperkalemia (0.6%-30.2%); 3 studies, cough (37%-50%); and 4 studies, renal impairment (0.6%-7.6%).Findings show that drug-related adverse effects are commonly reported in clinical trials and highlight the sizable burden of ADEs with medical therapy across patients with HFrEF. Additional real-world evidence and studies aiming to improve the tolerability of GDMT for patients with HFrEF are warranted.

BackgroundBleeding is a complication of percutaneous coronary intervention (PCI), leading to significant morbidity, mortality, and cost. Existing risk models produce a single estimate of bleeding risk anchored at a single point in time and do not update estimates as clinical information emerges, despite the dynamic nature of risk.ObjectiveWe sought to develop models that update estimates of bleeding risk over time, incorporating evolving clinical information, and to demonstrate updated predictive performance.MethodsUsing data available from the National Cardiovascular Data Registry (NCDR) CathPCI, we trained 6 different tree-based machine learning models to estimate the risk of bleeding at key decision points: 1) choice of access site, 2) prescription of medication prior to PCI, and 3) the choice of closure device.ResultsWe included 2,868,808 PCIs; 2,314,446 (80.7%) prior to 2014 for training and 554,362 (19.3%) remaining for validation. Discrimination improved from an AUROC of 0.812 (95% Confidence Interval: 0.812-0.812) using only presentation variables to 0.845 (0.845-0.845) using all variables. Among 123,712 patients classified as low risk by the initial model, 14,441 were reclassified as moderate risk (1.4% experienced bleeds), while 723 were reclassified as high risk (12.5% experienced bleeds). Among 160,165 patients classified as high risk by the initial model, 40 were reclassified to low risk (0% experienced bleeds), and 43,265 to moderate risk (2.5% experienced bleeds).ConclusionAccounting for the time-varying nature of data and capturing the association between treatment decisions and changes in risk provide up-to-date information that may guide individualized care throughout a hospitalization.Condensed AbstractExisting risk models for bleeding with PCI produce a single estimate anchored at a single point in time. We developed models that update estimates of bleeding risk over time, incorporating evolving clinical information, using data available from the National Cardiovascular Data Registry (NCDR) CathPCI. We trained 6 different machine learning models to estimate the risk of bleeding at key decision points, improving discrimination from an AUROC of 0.812 to 0.845, over time. Accounting for the time-varying nature of data and capturing association between treatments and changes in risk provide up-to-date information that may guide individualized care throughout a hospitalization.

ObjectiveAntimicrotubular agents are among the most commonly used classes of chemotherapeutic agents, but the risk of cardiovascular adverse events (CVAEs) remains unclear. Our objective was to study the CVAEs associated with antimicrotubular agents.MethodsThe Food and Drug Administration’s Adverse Event Reporting System was used to study CVAEs in adults from 1990 to 2020. Reported single-agent (only taxane or vinca alkaloid) CVAEs were compared with combination therapy (with at least one of the four major cardiotoxic drugs: anthracycline, HER2Neu inhibitors, tyrosine kinase inhibitors and checkpoint inhibitors) using adjusted polytomous logistic regression.ResultsOver 30 years, 134 398 adverse events were reported, of which 18 426 (13.4%) were CVAEs, with 74.1% due to taxanes and 25.9% due to vinca alkaloids. In 30 years, there has been a reduction in the proportion of reported CVAEs for taxanes from 15% to 11.8% (Cochran-Armitage P-trends ConclusionsAntimicrotubular agents are associated with CVAEs, especially in combination chemotherapy regimens. Based on this study, we suggest routine cardiovascular assessment of patients with cancer before initiating antimicrotubular agents in combination therapy.

Background: When presenting for atrial fibrillation (AF) ablation, women, compared with men, tend to have more nonpulmonary vein triggers and advanced atrial disease. Whether this informs differences in AF ablation strategy is not well described. We aimed to characterize ablation strategy and complications by sex, using the Get With The Guidelines-AF registry. Methods: From the Get With The Guidelines-AF registry ablation feature, we included patients who underwent initial AF ablation procedure between January 7, 2016, and December 27, 2019. Patients were stratified based on AF type (paroxysmal versus nonparoxysmal) and sex. We compared patient demographics, ablation strategy, and complications by sex. Results: Among 5356 patients from 31 sites who underwent AF ablation, 1969 were women (36.8%). Women, compared with men, were older (66.8±9.6 versus 63.4±10.6, P P P =0.0002; inferior mitral isthmus line: 10.2% versus 7.0%, P =0.01; floor line: 46.1% versus 40.6%, P =0.02) than in men. In multivariable analysis, the association between patient sex and complications from ablation was not statistically significant. Conclusions: In this US wide AF ablation quality improvement registry, women with nonparoxysmal AF were more likely to receive adjunctive lesion sets compared with men. These findings suggest that patient sex may inform ablation strategy in ways that may not be strongly supported by evidence and emphasize the need to clarify optimal ablation strategies by sex.

Using latent class analysis (LCA) of EMPA-REG OUTCOME (BI 10773 [Empagliflozin] Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients), this study identified distinct phenotypes in subjects with type 2 diabetes (T2D) and cardiovascular (CV) disease and explored treatment effects across phenotypes.In the EMPA-REG OUTCOME trial, empagliflozin reduced risk of CV death or hospitalization for heart failure (HHF) by 34% in subjects with T2D and CV disease. Among such subjects, there has been limited evaluation of clinical phenotypes.Overall, 7,020 participants were treated with empagliflozin 25 mg, 10 mg, or placebo. For this post hoc analysis, participants were randomly separated into training (two-thirds of patients) and validation (remaining one-third) sets. LCA identified 3 phenotype groups (n = 6,639 with complete data). The phenotype association with CV death or HHF and empagliflozin treatment effect across groups was explored by Cox regression (in training and validation sets).In the training set, phenotype group 1 (n = 1,463; 33.1%) included younger patients with shorter T2D duration and the highest estimated glomerular filtration rate (eGFR). Phenotype group 2 (n = 1,172; 26.5%) included more women with non-coronary artery disease. Phenotype group 3 (n = 1,785; 40.4%) included older patients with advanced coronary disease and the lowest eGFR. The risk of CV death varied across phenotypes (group 2 vs. 1: hazard ratio [HR]; 1.83; 95% confidence interval [CI]: 1.23 to 2.71; group 3 vs. 1: HR: 1.86; 95% CI: 1.30 to 2.67) with similar patterns for CV death or HHF. Consistent treatment effects of empagliflozin were seen across phenotypes in the training and validation sets (interaction p0.30).Among participants with T2D, this study identified 3 phenotypes with varying CV risk. The treatment effect across phenotypes reaffirms the robustness of CV death or HHF reduction with empagliflozin. (BI 10773 [Empagliflozin] Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients [EMPA-REG OUTCOME]; NCT01131676).

Background: The ADA’s “Standards of Medical Care in Diabetes” recommends use of an SGLT2 inhibitor or GLP-1 receptor agonist as one of the six drug classes after metformin (MET) in T2D patients. These therapies are preferred among T2D patients with cardiovascular disease (CVD) based on clinical trial results demonstrating significant improvement in clinical outcomes. We sought to examine the economic implications of sequential use of these therapies. Methods: An economic simulation model evaluating treatment in U.S. T2D patients after MET with empagliflozin (EMPA) as 2nd line and liraglutide (LIRA) as 3rd line vs. LIRA as 2nd line and EMPA as 3rd line was used to estimate the lifetime health and cost outcomes of T2D-related complications and adverse events (AEs). Complications, including CV death, myocardial infarction, stroke, and renal outcomes, were predicted using United Kingdom Prospective Diabetes Study risk equations and EMPA-REG OUTCOME data. A meta-analysis informed treatment-induced changes in HbA1c, SBP, and weight in patients without CVD. For each complication in patients with CVD, an indirectly estimated hazard ratio of LIRA vs. EMPA was applied. Costs ($2019), AE rates, and utilities were sourced from published literature. Results: Compared with LIRA as 2nd line, use of EMPA added 0.32 quality-adjusted life-years (QALYs) and led to lower lifetime costs (by $11,422/patient), suggesting dominance over 2nd line LIRA (improved health outcomes at lower cost). These results were similar across CVD subgroups. Patients with CVD at baseline compared to those without CVD showed larger gains in incremental QALYs (0.42 with CVD, 0.29 without CVD) with somewhat lower cost savings (by $9,550, $12,392, respectively) for 2nd line EMPA vs. LIRA, showing dominance in both subpopulations. Conclusion: For T2D patients with and without CVD, the use of EMPA on background MET was a dominant strategy for U.S. payers, associated with improved outcomes and lower costs as compared with LIRA. Disclosure O. Reifsnider: Consultant; Self; Boehringer Ingelheim International GmbH, Boehringer Ingelheim Pharmaceuticals, Inc. P. Pimple: Employee; Self; Boehringer Ingelheim Pharmaceuticals, Inc. Employee; Spouse/Partner; CVS Caremark. M.J.D. Stargardter: Consultant; Self; Boehringer Ingelheim International GmbH, Boehringer Ingelheim Pharmaceuticals, Inc. S. Brand: Consultant; Self; Boehringer Ingelheim International GmbH, Boehringer Ingelheim Pharmaceuticals, Inc. N. Desai: None. S. Shetty: Employee; Self; Boehringer Ingelheim Pharmaceuticals, Inc.

In EMPA-REG OUTCOME, empagliflozin (EMPA) reduced risk of cardiovascular (CV) death by 38% and hospitalization for heart failure (HHF) by 35% in patients with type 2 diabetes (T2D) and CV disease. We aimed to identify phenotypes of patients with different risk of outcomes and to explore treatment effects across these groups. Overall, 7020 patients were treated with EMPA 25, 10 mg or placebo (PBO). For this post-hoc analysis, patients were randomly separated into training (2/3) and validation sets (1/3 of patients). Latent class analysis identified 3 clusters using 6639 patients with complete data. The association of clusters to CV death and CV death/HHF, and treatment effect of EMPA vs. PBO across clusters was explored by Cox regression. Cluster 1 included younger patients with shorter T2D duration. Cluster 2 included more women with non-coronary atherosclerotic disease (CAD), and Cluster 3 older patients with advanced CAD. In the training set, risk of CV death varied across clusters (Cluster 2 vs. 1 HR 1.83 [95% CI 1.23, 2.71], Cluster 3 vs. 1 HR 1.86 [1.30, 2.67]) with similar pattern for CV death/HHF. Treatment effect of EMPA was consistent across clusters (Figure). Results were replicated in the validation set. We identified 3 phenotypes of patients with varying risk of outcomes. The consistent treatment effect across clusters reaffirms the robustness of CV death/HHF reduction with EMPA. Disclosure A. Sharma: Advisory Panel; Self; Boehringer Ingelheim International GmbH, Roche Pharma. Research Support; Self; Bristol-Myers Squibb, Merck & Co., Inc. Speaker’s Bureau; Self; Novartis Pharmaceuticals Corporation. A. Ofstad: Employee; Self; Boehringer Ingelheim International GmbH. T. Ahmad: None. B. Zinman: Advisory Panel; Self; Abbott, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Novo Nordisk Inc., Sanofi-Aventis. I. Zwiener: Employee; Self; Boehringer Ingelheim International GmbH. D.H. Fitchett: Consultant; Self; AstraZeneca, Boehringer Ingelheim International GmbH. Speaker’s Bureau; Self; Lilly Diabetes. Other Relationship; Self; Novo Nordisk Inc. C. Wanner: Advisory Panel; Self; Eli Lilly and Company, Merck & Co., Inc., Mundipharma International. Consultant; Self; Boehringer Ingelheim (Canada) Ltd., Sanofi Genzyme. Speaker’s Bureau; Self; AstraZeneca. Other Relationship; Self; Boehringer Ingelheim International GmbH. J.T. George: Employee; Self; Boehringer Ingelheim International GmbH. S. Hantel: Employee; Self; Boehringer Ingelheim Pharma GmbH & Co. KG. N. Desai: None. R.J. Mentz: Consultant; Self; Amgen, AstraZeneca, Bayer Healthcare Pharmaceuticals Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Merck & Co., Inc., Novartis Pharmaceuticals Corporation, Sanofi. Research Support; Self; GlaxoSmithKline plc. Funding Boehringer Ingelheim and Eli Lilly and Company Diabetes Alliance

The aim of the study was to project the long-term net health benefits of mavacamten for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (HCM) in the United States.A Markov model with 4 mutually exclusive health states (New York Heart Association [NYHA] functional classes I, II, and III/IV and death) was developed to project the life-years (LYs) and quality-adjusted life-years (QALYs) over a lifetime horizon for patients with symptomatic obstructive HCM receiving mavacamten with or without β-blocker (BB) or calcium channel blocker (CCB) monotherapy or placebo with or without BB or CCB monotherapy. The model simulated a patient cohort with a starting age of 59 years and 41% women. Transition probabilities across NYHA functional classes were estimated using data from the Phase III Clinical Study to Evaluate Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy (EXPLORER-HCM) and the EXPLORER long-term extension (EXPLORER-LTE) cohort from the Long-term Safety Extension Study of Mavacamten in Adults who Have Completed MAVERICK-HCM or EXPLORER-HCM (MAVA-LTE) trial and were extrapolated after week 30. The mortality risks of NYHA functional class I were assumed to be the age- and sex-specific mortality risks of the US general population. The mortality risks for NYHA class II and III/IV were estimated using those for class I in conjunction with the relative mortality risks derived using patients with obstructive HCM from a large real-world registry. Health state utilities for each treatment were estimated from EXPLORER-HCM. Both LYs and QALYs were aggregated over a lifetime for each treatment arm, discounted at 3% annually, and compared between the 2 arms. Sensitivity analyses were conducted to evaluate the robustness of the model findings.Over a lifetime, treatment with mavacamten with or without BB or CCB monotherapy was associated with 3.67 incremental LYs compared with placebo with or without BB or CCB monotherapy (13.00 vs 9.33 LYs). Compared with individuals in the placebo group, patients in the mavacamten group were projected to spend 6.17 additional LYs in NYHA functional class I and 0.04 and 2.46 fewer LYs in NYHA functional classes II and III/IV, respectively. With utilities incorporated, mavacamten with or without BB or CCB monotherapy was associated with 4.17 additional QALYs compared with placebo with or without BB or CCB monotherapy (11.74 vs 7.57 QALYs). In the sensitivity analyses, incremental benefits ranged from 1.55 to 6.21 LYs and from 2.48 to 6.19 QALYs across the scenarios.This model projected substantial net health benefits associated with mavacamten for symptomatic obstructive HCM owing to improved patient survival and quality of life. The projected QALY gain underscored the likely long-term clinical value of mavacamten in symptomatic obstructive HCM.

In a collaborative effort, the Federal Aviation Administration (FAA) and the Boeing Company are assessing bonded repair technology of composite panels representative of transport airplane wing structure through test and analysis using the FAA’s Aircraft Beam Structural Test fixture. Emphasis has been placed on investigating methods and tools used to conduct analysis and predict structural performance of bonded repairs and those used to monitor and evaluate repair quality over the life of the part. The initial baseline phase of the program verified analysis models and provided an initial reference point for inspection and monitoring systems used to detect and track damage formation. Recent second-phase efforts support bonded repair size limit (BRSL) studies and methods used to predict the limit load residual strength for a failed scarfed repair in solid composite laminates. In general, methods under development for BRSL residual strength predictions correlated well with test results.

Efforts to improve prescription of oral anticoagulation (OAC) drugs in patients with atrial fibrillation have had limited success in improving guideline adherence.We evaluated adherence to the American College of Cardiology/American Heart Association performance measures for OAC in eligible patients with a CHAThe median (25th, 75th percentile) age was 73 years (65, 81 years); 51% were female; and the median (25th, 75th percentile) CHAAmong hospitals participating in the GWTG-AFIB quality improvement program, OAC prescription at discharge in eligible guideline-indicated patients increased significantly and improved consistently over time. These data confirm that high-level adherence to guideline-recommended stroke prevention is achievable.

Presenting the clinical trials supporting FDA approvals of drugs in cardiovascular disease and diabetes that were published in the biomedical literature in a manner that was discordant with the FDA reviewerâ s interpretation. (DOCX 32 kb)

PRISMA checklist. (DOC 63 kb)

Background: Over the last decade, acute myocardial infarction (AMI) incidence and mortality have decreased substantially. Yet it is unknown whether these improvements were consistent across communities of different economic status and geographic regions, for which efforts to improve cardiovascular disease prevention and management may have had variable impact. Objective: To compare trends in risk-standardized AMI hospitalization and 1-year mortality rates from 1999 to 2013 between counties of low, average, and high median income, and to test the effects of income over time and across the 4 U.S. geographic regions. Methods: We performed an observational analysis comparing trends in county-level risk-standardized (age, sex, race) AMI hospitalization and 1-year mortality rates from 1999 to 2013 among Medicare beneficiaries ≥65 years, testing for effects of county-income. Counties were stratified by median income percentile using 1999 U.S. Census Bureau data, adjusted for inflation, as: low (75th) income groups. Using a mixed effects model, we compared trends in AMI hospitalization and mortality rates, stratified by county income. We tested for a lagged effect among low-income counties and compared trends between the 4 U.S. regions. Results: Income was significantly associated with AMI hospitalization, but not 1-year mortality rates. In the 15-year period, AMI risk-standardized hospitalization and mortality rates declined across all three county income groups, though absolute hospitalization rates differed significantly by county income groups (Figure). Low-income county hospitalization rates consistently lagged behind high-income county rates by 4.3 (95%CI: 3.1-5.9) years. There was no difference in rate of decline by geographic region. Conclusion: In this national study of AMI trends from 1999 to 2013, Medicare beneficiaries residing in counties of all income levels achieved substantial declines in AMI hospitalization and mortality. These broad-scale declines may reflect the success of focused AMI prevention efforts or other more secular trends. Nonetheless, disparities persist with low-income counties lagging behind high-income counties - a focus for future national efforts.

High medical costs create significant burdens. Research indicates that doctors have little awareness of costs. This study tested whether a brief educational intervention could increase residents' awareness of cost-effectiveness and reduce costs without negatively affecting patient outcomes.The authors conducted a clustered randomized controlled trial of 33 teams (96 residents) at an internal medicine residency program (2009-2010). The intervention was a 45-minute teaching session; residents reviewed the hospital bill of a patient for whom they had cared and discussed reducing unnecessary costs. Primary outcomes were laboratory, pharmacy, radiology, and total hospital costs per admission. Secondary measures were length of stay (LOS), intensive care unit (ICU) admission, 30-day readmission, and 30-day mortality. Multivariate adjustment controlled for patient demographics and health. A follow-up survey assessed resident attitudes three months later.Among 1,194 patients, there were no significant cost differences between intervention and control groups. In the intervention group, 30-day readmission was higher (adjusted odds ratio 1.51, P = .010). There was no effect on LOS or the composite outcome of readmission, mortality, and ICU transfer. In a subgroup analysis of 835 patients newly admitted during the study, the intervention group incurred $163 lower adjusted lab costs per admission (P = .046). The follow-up survey indicated persistent differences in residents' exposure to concepts of cost-effectiveness (P = .041).A brief intervention featuring a discussion of hospital bills can fill a gap in resident education and reduce laboratory costs for a subset of patients, but may increase readmission risk.

The Million Hearts Cardiovascular Disease Risk Reduction Model provides financial incentives for practices to lower 10-year atherosclerotic cardiovascular disease (ASCVD) risk for high risk (ASCVD >=30%) Medicare patients. We describe the potential impact of reducing modifiable risk factors on ASCVD

Introduction: Evolocumab (AMG 145), a fully human monoclonal antibody against proprotein convertase subtilisin kexin type 9 (PCSK9), significantly reduces low-density lipoprotein-cholesterol (LDL-C) by ~65%. Whether baseline PCSK9 levels impact the efficacy of evolocumab remains undefined. Methods: The mean placebo-controlled percent change from baseline in LDL-C measured by ultracentrifugation at week 10 & 12 was calculated for evolocumab 140 mg Q2W and 420 mg QM in 2293 patients from the pooled phase 3 trials. Median PCSK9 levels were measured in 138 patients from a substudy of the pooled phase 2 trials. For both analyses, patients were stratified into quartiles based upon baseline PCSK9 levels. Interaction tests were performed to evaluate for heterogeneity across quartiles. Results: At baseline in the pooled phase 3 trials, the median PCSK9 level was 323 ng/mL (25 th %ile 258 ng/mL; 75 th %ile 406 ng/mL). Demographics were similar across quartiles of baseline PCSK9, but, as expected, patients with higher levels of baseline PCSK9 were more likely to be receiving more intensive background statin therapy and had lower levels of LDL-C at baseline. Evolocumab 140 mg Q2W reduced PCSK9 levels by >90% 1 week after dosing and levels remained low (~100 ng/mL), regardless of baseline PCSK9 level (Figure top left). Evolocumab 420 mg QM rendered PCSK9 levels undetectable 1 week after dosing and reduced by >90% 2 weeks after dosing, regardless of baseline PCSK9 levels (Figure top right); 3 weeks after dosing PCSK9 levels remained low (~100 ng/mL) and by 4 weeks levels remained proportionately reduced by nearly half. Evolocumab significantly (P Conclusion: Evolocumab, a PCSK9 inhibitor, when administered 140 mg biweekly or 420 mg monthly, consistently and substantially reduces PCSK9 and LDL-C regardless of a patient’s baseline level of PCSK9.

Background: Lacking health insurance and having financial concerns are known barriers to emergency care access in patients with AMI. However we do not know whether being uninsured or underinsured is associated with increased prehospital delay among young adults specifically, and whether this relationship varies by gender. Methods: We used data from the VIRGO study, a multicenter prospective study of women and men aged 18-55y with AMI (3,572). We excluded non-US patients (587) and those with unknown prehospital delay time (32) or insurance status (2). Participants were divided into 3 groups by health insurance status: 1. uninsured; 2. underinsured (insured but avoided care or medications due to cost concerns); 3. adequately insured (insured and without the above concerns). Prehospital delay was defined as the time interval between symptom onset and hospital presentation. The association between insurance groups and prehospital delay of >12 hours was examined using chi-square test. A hierarchical logistic model was used to evaluate the independent effect of insurance groups on prehospital delay of >12 hours adjusting for site clustering, demographics, medical history and clinical characteristics. Results: Of the 2951 young individuals with AMI in our study, 1987 were women (67.3%); the median age was 48 (IQR= 44, 52); 38% were underinsured; and 23%, uninsured. While women were less likely than men to be uninsured (21.8 vs 25.4%, P=0.03), they were more likely to be underinsured (60.5 vs 53.6%, P12 hours of prehospital delay: 38% of women and 29% of men (P=0.0001; figure). Insurance status was not associated with delays of >12 hrs in women (P=0.10) or men (P=0.57). After adjustments, the underinsured (OR 0.99; 95%CI 0.81, 1.19) and uninsured (OR 1.11; 95% CI 0.88, 1.39) did not have higher odds of having >12 hrs of prehospital delay compared to the adequately insured. Conclusion: More than 1 in 3 young individuals with AMI presented to hospitals beyond 12 hours after onset of symptoms. Insurance status was not associated with prehospital delays in this population. Although women are more likely to have >12 hours of prehospital delay, this difference is not attributable to differences in insurance status. Factors beyond the provision of insurance will need to be addressed to reduce delays.

In recent years, the application of high-performance FRP composites in construction industry has grown tremendously in several different directions. The composite materials have been used extensively in manufacturing stand-alone structural members such as beams, columns, and wall panels in cooling tower system, in strengthening and retrofitting the existing but deteriorating structures to prevent the corrosion of steel members and the spalling of concrete surface. Other application area under consideration include infrastructure and facility members for transmission towers, closed circuit television poles, sign posts, guardrails, bridge railings, and light-gage structural system. The primary purpose of this paper is to investigate an application of FRP composites in product development for utility and/or lighting fixture poles, highway sign post, and medium size of transmission tower elements. This kind of infrastructural system can be designed, constructed, and operated in many challenging environments on planet earth, in-space, and on other planetary bodies such as the moon and mars. The objectives of this investigation are: (a) to determine the bending and buckling strengths of various FRP poles using eigenvalue solution, (b) to evaluate and compare the ultimate strength and stress of the facility poles using three dimensions finite element computational analysis, and (c) to perform the parametric structural efficiency analysis for determining an optimum rigidity length ratio, a/l, between the variable length from the fixed end to the overall length of the pole. The results indicate that the rigidity length ratio, a/l, as well as the moment of inertia ratio, I T / I B , have significant influence on the performance of facility poles, The study also proves that the step pole used in analytical model is light weight than the convention tapered pole for particular configurations.

Carotid endarterectomy (CEA) has become established as the preferred approach to the management of critical carotid stenosis. Carotid angioplasty with stenting (CAS) has recently arisen as an alternative in the treatment of carotid occlusive disease. This report describes our experience with carotid angioplasty applied to an unselected patient population suffering from high-grade carotid occlusive disease.All patients suffering from carotid stenosis (50% symptomatic or80% asymptomatic) were offered CAS or CEA. The first 39 patients who underwent attempted CAS over this last year are reported here. CAS was performed with the SMART PRECISE or ACCULINK stents. All procedures were performed with cerebral protection.The planned procedure success rate was 97% and the major adverse event (MAE) rate was 2.6% in 38 patients who underwent successful CAS. This included a minor stroke and a subendocardial myocardial infarction in the same individual. Both events were attributed to sustained postprocedural hypotension probably induced by increased carotid sinus activity.CAS can be accomplished with a MAE rate comparable to CEA and will likely become the dominant alternative to CEA for the management of carotid stenosis. In the setting of equivalent morbidity, it appears likely that a nonsurgical option will be preferred by patients.