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• E-learning modules can facilitate guidelines-based management education for ASCVD. • Lipid experts pilot-tested and suggested revisions for module content. • Primary care clinicians and cardiologists pilot-tested e-learning modules. • Clinician feedback was used to improve user experience. • Modules will educate clinicians on best practices for high-risk ASCVD management. Atherosclerotic cardiovascular disease (ASCVD) remains the leading cause of death in the United States. Case-based learning using electronic delivery of the modules can educate clinicians and improve translation of evidence-based guidelines into practice for high-risk ASCVD patients. To develop and optimize module design, content, and usability of e-learning modules to teach clinicians evidence-based management in accordance with multi-society guidelines for high-risk ASCVD patients that will be implemented and evaluated in U.S. health systems in the TEACH-ASCVD study. Seven e-learning modules were created by a committee of lipid experts. Focus groups were conducted with lipid experts to elicit feedback on case content followed by interviews with a target audience of clinicians to assess usability of the online module platform. Responses from both groups were evaluated, and appropriate changes were made to improve the e-learning modules. Design of the TEACH-ASCVD study is presented. Feedback regarding case content by lipid experts included providing more detailed patient histories, clarifying various diagnostic criteria, and emphasizing clinical best practices based on evidence-based guidelines. The target audience clinician group reported an agreeable experience with the e-learning modules but noted a discordance between the evidence-based guidelines and clinical decision-making in their own practices. Participants felt the modules would help educate clinicians in managing high-risk ASCVD patients. Clinicians must be informed of best practices as the field of lipidology continues to evolve. E-learning modules provide a concise, valuable, and accessible mechanism for educating clinicians regarding changes in the field to deliver the best patient care. [ABSTRACT FROM AUTHOR]

Lifelong oral anticoagulation is recommended in patients with atrial fibrillation (AF) to prevent stroke. Over the last decade, multiple new oral anticoagulants (OACs) have expanded the number of treatment options for these patients. While population-level effectiveness of OACs has been compared, it is unclear if there is variability in benefit and risk across patient subgroups. We analyzed claims and medical data for 34,569 patients who initiated a nonvitamin K antagonist oral anticoagulant (non-vitamin K antagonist oral anticoagulant (NOAC); apixaban, dabigatran, and rivaroxaban) or warfarin for nonvalvular AF between 08/01/2010 and 11/29/2017 from the OptumLabs Data Warehouse. A machine learning (ML) method was applied to match different OAC groups on several baseline variables including, age, sex, race, renal function, and CHA 2 DS 2 -VASC score. A causal ML method was then used to discover patient subgroups characterizing the head-to-head treatment effects of the OACs on a primary composite outcome of ischemic stroke, intracranial hemorrhage, and all-cause mortality. The mean age, number of females and white race in the entire cohort of 34,569 patients were 71.2 (SD, 10.7) years, 14,916 (43.1%), and 25,051 (72.5%) respectively. During a mean follow-up of 8.3 (SD, 9.0) months, 2,110 (6.1%) of patients experienced the composite outcome, of whom 1,675 (4.8%) died. The causal ML method identified 5 subgroups with variables favoring apixaban over dabigatran; 2 subgroups favoring apixaban over rivaroxaban; 1 subgroup favoring dabigatran over rivaroxaban; and 1 subgroup favoring rivaroxaban over dabigatran in terms of risk reduction of the primary endpoint. No subgroup favored warfarin and most dabigatran vs warfarin users favored neither drug. The variables that most influenced favoring one subgroup over another included Age, history of ischemic stroke, thromboembolism, estimated glomerular filtration rate, Race, and myocardial infarction. Among patients with AF treated with a NOAC or warfarin, a causal ML method identified patient subgroups with differences in outcomes associated with OAC use. The findings suggest that the effects of OACs are heterogeneous across subgroups of AF patients, which could help personalize the choice of OAC. Future prospective studies are needed to better understand the clinical impact of the subgroups with respect to OAC selection. [Display omitted] [ABSTRACT FROM AUTHOR]

Acute Heart failure (AHF) is among the most frequent causes of hospitalization in the United States, contributing to substantial health care costs, morbidity, and mortality. Inpatient initiation of guideline-directed medical therapy (GDMT) is recommended for patients with heart failure with reduced ejection fraction (HFrEF) to reduce the risk of cardiovascular death or HF hospitalization. However, underutilization of GDMT prior to discharge is pervasive, representing a valuable missed opportunity to optimize evidence-based care. The PR agmatic Trial O f Messaging to P roviders about T reatment of A cute H eart F ailure tests the effectiveness of an electronic health record embedded clinical decision support system that informs providers during hospital management about indicated but not yet prescribed GDMT for eligible AHF patients with HFrEF. PR agmatic Trial O f Messaging to P roviders about T reatment of A cute H eart F ailureis an open-label, multicenter, pragmatic randomized controlled trial of 1,012 patients hospitalized with HFrEF. Eligible patients randomized to the intervention group are exposed to a tailored best practice advisory embedded within the electronic health record that alerts providers to prescribe omitted GDMT. The primary outcome is an increase in the proportion of additional GDMT medication classes prescribed at the time of discharge compared to those in the usual care arm. [ABSTRACT FROM AUTHOR]

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• The utility of telehealth services for lipid management remains understudied. • Telehealth has had a positive to neutral impact on improving lipid metrics. • Facilitators to telehealth include multidisciplinary care and patient-centeredness. • Technology dexterity and clinician reimbursement remain major barriers to telehealth. • Future interventions should emphasize a hybrid model of patient-centered care. Telehealth services have been implemented to deliver care for patients living with many chronic conditions and have expanded greatly during the COVID-19 pandemic. Little is known about the current or future impacts of telehealth on lipid management practices. The PubMed database was searched from inception to June 25, 2021, with the keywords "lipids or cholesterol" and "telehealth," which yielded 376 published articles. Telehealth was defined as a synchronous visit between a patient and clinician that replaced an in-office appointment. Studies that solely used remote monitoring, mobile health technologies, or callbacks of results, were excluded. Articles must have measured lipid values. Review articles and protocol papers were not included. After evaluation, 128 abstracts were included for full text evaluation, with 55 full-text articles eventually included. Of the articles, 29 were randomized clinical trials, 15 were pre-post evaluations, and 11 were other study designs. Telehealth had positive to neutral impacts on lipid management. Reported facilitators include easier implementation of multidisciplinary approaches to care, and utilization of patient-centered programs. Reported barriers to telehealth services include technological barriers, such as various skill levels with technology; systems barriers, such as cost and reimbursement; patient-related barriers, including patient non-adherence; and clinician-related barriers, such as difficulty standardizing care. Clinicians reported improved satisfaction among patients but had mixed feelings regarding their ability to deliver quality care. Telemedicine use to provide care for individuals with lipid conditions has expanded during the COVID-19 pandemic, but more research is needed to determine its potential as a sustainable tool for lipid management. [ABSTRACT FROM AUTHOR]

Background: Despite guideline recommendations to optimize low-density lipoprotein cholesterol (LDL-C) reduction with intensification of lipid-lowering therapy (LLT) in patients with atherosclerotic cardiovascular disease (ASCVD), few of these patients achieve LDL-C < 70 mg/dL in practice.Purpose: We developed a real-time, targeted electronic health record (EHR) alert with embedded ordering capability to promote intensification of evidence based LLT in outpatients with very high risk ASCVD.Methods: We designed a pragmatic, multicenter, single-blind, cluster randomized trial to test the effectiveness of an EHR-based LLT intensification alert. The study will enroll about 100 providers who will be randomized to either receive the alert or undergo usual care for outpatients with high risk ASCVD with LDL-C > 70 mg/dL. Total enrollment will include 2,500 patients. The primary outcome will be the proportion of patients with LLT intensification at 90 days. Secondary outcomes include achieved LDL-C at 6 months and the proportion of patients with LDL-C < 70 mg/dL or < 55 mg/dL at 6 months.Results: Enrollment of 1,250 patients (50% of goal) was reached within 47 days (50% women, mean age 72, median LDL-C 91). At baseline, 71%, 9%, and 3% were on statins, ezetimibe, or proprotein convertase subtilisin/kexin type 9 inhibitors, respectively.Conclusions: PRagmatic Trial of Messaging to Providers about Treatment of HyperLIPIDemia has rapidly reached 50% enrollment of patients with very high risk ASCVD, demonstrating low baseline LLT utilization. This pragmatic, EHR-based trial will determine the effectiveness of a real-time, targeted EHR alert with embedded ordering capability to promote LLT intensification. Findings from this low-cost, widely scalable intervention to improve LDL-C may have important public health implications.Trial Registration: clinicaltrials.gov NCT04394715. [ABSTRACT FROM AUTHOR]

Background: Little is known about the prevalence and prognostic impact of preexisting frailty on acute care and in-hospital outcomes in older adults in the setting of acute myocardial infarction (AMI).Methods: Preexisting frailty was assessed at baseline in consecutive AMI patients ≥65 years of age treated at 778 hospitals participating in the NCDR ACTION Registry between January 1, 2015 to December 31, 2016. Three domains of preexisting frailty (cognition, ambulation, and functional independence) were abstracted from chart review and summed in 2 ways: an ACTION Frailty Scale based on responses to 6 groups adapted from the Canadian Study of Health and Aging Clinical Frailty Scale and an ACTION Frailty Score derived by summing a rank score of 0-2 assigned for each grade (total ranged between 0 to 6). Multivariable logistic regression examined the association between assigned frailty by score or scale and in-hospital mortality.Results: Among 143,722 older AMI patients, 108,059 (75.2%) were fit and/or well and 6,484 (4.5%) were vulnerable to frailty, while 7,527 (5.2%) had mild, 3,913 (2.7%) had moderate, 2,715 had (1.9%) severe, and 632 (0.4%) had very severe frailty according to the ACTION Frailty Scale, while 14,392 (10.0%) could not be categorized due to incomplete ascertainment. Frail patients were older, more frequently female, of non-white race and/or ethnicity, and less likely to be treated with guideline-recommended therapies. Increasing severity of frailty by this scale was associated with a step-wise higher risk for in-hospital mortality (P-trend < .001). Patient categories of the ACTION Frailty Score provided similar results. After adjustment, each 1-unit increase in Frailty Score was associated with a 12% higher mortality risk (OR 1.12, 95% CI 1.10-1.15).Conclusions: Among older patients with acute myocardial infarction, frailty is common and independently associated with in-hospital mortality. These findings show the importance of pragmatic evaluation of frailty in hospital-level quality scores, guideline recommendations, and incorporation into other registry data collection efforts. [ABSTRACT FROM AUTHOR]

Background: Despite multiple trials comparing rate with rhythm control, there is no consensus on the optimal management of first-detected atrial fibrillation (AF).Objective: We analyzed current patterns of care for first-detected AF in the nationwide Get With The Guidelines® - Atrial Fibrillation registry.Methods: Patients hospitalized with first-detected AF from 2013 to 2019 were included, and a descriptive analysis was performed comparing planned rate with rhythm control. Multivariable logistic regression analysis was performed to identify predictors for choosing rhythm over rate control.Results: Of the 86,759 patients with AF, 17.8% (15,473) had first-detected AF; 11,685 patients were included from 126 sites. Overall, 51.3% (5999) of patients were treated with rate control and 48.7% (5686) with rhythm control at admission. Patients with planned rhythm control had a shorter length of stay and were more likely to be discharged home than a facility. A higher percentage of patients with planned rhythm control were discharged on anticoagulation than those with planned rate control (75.6% vs 70.9%) despite a higher underlying stroke risk in the rate control group (higher median CHA2DS2-VASc score 4; Q1-Q3 2-5 for rate control vs 3; Q1-Q3 2-4 for rhyhtm control; P < .001). While Hispanic ethnicity, Medicaid insurance, age >70 years, and liver disease decreased the likelihood of rhythm control, factors such as heart failure, stroke, or prior bleeding diathesis had no association with the chosen treatment strategy.Conclusion: Less than half of the patients with first-detected AF receive rhythm control at admission. Given recent trial results, further studies should assess the long-term impact of rhythm control on patients' symptoms and quality of life, cardiovascular morbidity, and mortality. [ABSTRACT FROM AUTHOR]

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Increasing patient and therapeutic complexity have created both challenges and opportunities for heart failure care. Within this background, the coronavirus disease-2019 pandemic has disrupted care as usual, accelerating the need for transition from volume-based to value-based care, and demanding a rapid expansion of telehealth and remote care for heart failure. Patients, clinicians, health systems, and payors have by necessity become more invested in these issues. Herein we review recent changes in health care policy related to the movement from volume to value-based payment and from in-person to remote care delivery. [ABSTRACT FROM AUTHOR]

Background: The Get With The Guidelines - Atrial Fibrillation (GWTG-AFIB) Registry uses achievement and quality measures to improve the care of patients with atrial fibrillation (AF). We sought to evaluate overall and site-level variation in attainment of these measures among sites participating in the GWTG-AFIB Registry.Methods: From the GWTG-AFIB registry, we included patients with AF admitted between 1/3/2013 and 6/30/2019. We described patient-level attainment and variation in attainment across sites of 6 achievement measures with 1) defect-free scores (percent of patients with all eligible measures attained), and 2) composite opportunity scores (percent of all eligible patient measures attained). We also described attainment of 11 quality measures at the patient-level.Results: Among 80,951 patients hospitalized for AF (age 70±13 years, 47.0% female; CHA2DS2-VASc 3.6±1.8) at 132 sites. Site-level defect-free scores ranged from 4.7% to 85.8% (25th, 50th, 75th percentile: 32.7%, 52.1%, 64.4%). Composite opportunity scores ranged from 39.4% to 97.5% (25th, 50th, 75th: 68.1%, 80.3%, 87.1%). Attainment was notably low for the following quality measures: 1) aldosterone antagonist prescription when ejection fraction ≤35% (29% of those eligible); and 2) avoidance of antiplatelet therapy with OAC in patients without coronary/peripheral artery disease (81% of those eligible).Conclusions: Despite high overall attainment of care measures across GWTG-AFIB registry sites, large site variation was present with meaningful opportunities to improve AF care beyond OAC prescription, including but not limited to prescription of aldosterone antagonists in those with AF and systolic dysfunction and avoidance of non-indicated adjunctive antiplatelet therapy. [ABSTRACT FROM AUTHOR]

Heart failure with reduced ejection fraction (HFrEF) is one of the most common chronic illnesses in the United States and carries significant risk of morbidity and mortality. Use of guideline-directed medical therapy (GDMT) for patients with HFrEF has been shown to dramatically improve outcomes, but adoption of these treatments remains generally low. Possible explanations for poor GDMT uptake include lack of knowledge about recommended management strategies and provider reluctance due to uncertainties regarding application of said guidelines to real-world practice. One way to overcome these barriers is by harnessing the electronic health record (EHR) to create patient-centered "best practice alerts" (BPAs) that can guide clinicians to prescribe appropriate medical therapies. If found to be effective, these low-cost interventions can be rapidly applied across large integrated healthcare systems. The PRagmatic Trial Of Messaging to Providers about Treatment of Heart Failure (PROMPT-HF) trial is a pragmatic, cluster randomized controlled trial designed to test the hypothesis that tailored and timely alerting of recommended GDMT in heart failure (HF) will result in greater adherence to guidelines when compared with usual care. PROMPT-HF has completed enrollment of 1,310 ambulatory patients with HFrEF cared for by 100 providers who were randomized to receive a BPA vs usual care. The BPA alerted providers to GDMT recommended for their patients and displayed current left ventricular ejection fraction (LVEF) along with the most recent blood pressure, heart rate, serum potassium and creatinine levels, and estimated glomerular filtration rate. It also linked to an order set customized to the patient that suggests medications within each GDMT class not already prescribed. Our goal is to examine whether tailored EHR-based alerting for outpatients with HFrEF will lead to higher rates of GDMT at 30 days post randomization when compared with usual care. Additionally, we are assessing clinical outcomes such as hospital readmissions and death between the alert versus usual care group. Trial Registration: Clinicaltrials.gov NCT04514458. [ABSTRACT FROM AUTHOR]

Background: Heart failure (HF) is a major driver of health care costs in the United States and is increasing in prevalence. There is a paucity of contemporary data examining trends among hospitalizations for HF that specifically compare HF with reduced or preserved ejection fraction (HFrEF or HFpEF, respectively).Methods and Results: Using the National Inpatient Sample, we identified 11,692,995 hospitalizations due to HF. Hospitalizations increased from 1,060,540 in 2008 to 1,270,360 in 2018. Over time, the median age of patients hospitalized because of HF decreased from 76.0 to 73.0 years (P < 0.001). There were increases in the proportions of Black patients (18.4% in 2008 to 21.2% in 2018) and of Hispanic patients (7.1% in 2008 to 9.0% in 2018; P < 0.001, all). Over the study period, we saw an increase in comorbid diabetes, sleep apnea and obesity (P < 0.001, all) in the entire cohort with HF as well as in the HFrEF and HFpEF subgroups. Persons admitted because of HFpEF were more likely to be white and older compared to admissions because of HFrEF and also had lower costs. Inpatient mortality decreased from 2008 to 2018 for overall HF (3.3% to 2.6%) and HFpEF (2.4% to 2.1%; P < 0.001, all) but was stable for HFrEF (2.8%, both years). Hospital costs, adjusted for inflation, decreased in all 3 groups across the study period, whereas length of stay was relatively stable over time for all groups.Conclusions: The volume of patients hospitalized due to HF has increased over time and across subgroups of ejection fraction. The demographics of HF, HFrEF and HFpEF have become more diverse over time, and hospital inpatient costs have decreased, regardless of HF type. Inpatient mortality rates improved for overall HF and HFpEF admissions but remained stable for HFrEF admissions. [ABSTRACT FROM AUTHOR]

We conducted a retrospective study using the NIS database from 2008 to 2018 to examine the most contemporary national hospitalization trends of transcatheter (TAVR) and surgical (SAVR) aortic valve replacement regarding volume, patient and hospital demographics and economics, resource utilization, total cost of stay, and in-hospital mortality. We demonstrate that TAVR procedures have been performed on a slow by steadily diversifying patient population while volume has grown significantly, while in-hospital mortality, length of stay, discharge home, and costs have improved, whereas these metrics have generally remained stable for SAVR. These trends will likely drive continued TAVR adoption, greatly expanding the overall aortic stenosis patient population eligible for AVR. [ABSTRACT FROM AUTHOR]

Background: The Department of Justice (DOJ) investigated implantable cardioverter-defibrillators (ICDs) not meeting the Centers for Medicare & Medicaid Services National Coverage Determination (NCD) criteria, resulting in increased adherence to the NCD criteria. Trends of the specific reasons for patients not meeting the NCD criteria and in-hospital outcomes for those patients are not known.Methods and Results: We analyzed 300,151 primary-prevention ICDs from 2007-2015 at 1809 hospitals. We calculated the rates of in-hospital adverse events and the proportion of ICDs not meeting the 4 NCD criteria before and after the announcement of the DOJ investigation, stratified by whether hospitals paid settlements to the DOJ. Most reductions in the use of devices in patients not meeting NCD criteria were in patients with recently diagnosed heart failure (15.5%-6.8% for settled; 13.5%-7.3% for nonsettled) and who had had a recent myocardial infarction (8.4%-1.3% for settled; 7.4% to 1.5% for nonsettled). Adverse-event rates were significantly higher for ICDs not meeting NCD criteria (odds ratio 1.26 for settled; P < 0.001; 1.18 for nonsettled; P = 0.001).Conclusions: After the investigation, there was a rapid reduction in the placement of ICDs in patients with recent acute myocardial infarction or recent diagnosis of heart failure. Patients who did not meet NCD criteria experienced more in-hospital adverse events and higher mortality rates. [ABSTRACT FROM AUTHOR]

Background: It remains unclear why depression is associated with adverse outcomes in patients with heart failure (HF). We examine the relationship between depression and clinical outcomes among patients with HF with reduced ejection fraction managed with guideline-directed medical therapy (GDMT).Methods and Results: Using the GUIDE-IT trial, 894 patients with HF with reduced ejection fraction were stratified according to a history of depression, and Cox proportional hazards regression modeling was used to examine the association with outcomes. There were 140 patients (16%) in the overall cohort who had depression. They tended to be female (29% vs 46%, P < .001) and White (67% vs 53%, P = .002). There were no differences in GDMT rates at baseline or at 90 days; nor were there differences in target doses of these therapies achieved at 90 days (NS, all). amino-terminal pro-B-type natriuretic peptide levels at all time points were similar between the cohorts (P > .05, all). After adjustment, depression was associated with all-cause hospitalizations (hazard ratio, 1.42, 95% confidence interval 1.11-1.81, P < .01), cardiovascular death (hazard ratio, 1.69, 95% confidence interval 1.07-2.68, P = .025), and all-cause mortality (hazard ratio, 1.54, 95% confidence interval 1.03-2.32, P = .039).Conclusions: Depression impacts clinical outcomes in HF regardless of GDMT intensity and amino-terminal pro-B-type natriuretic peptide levels. This finding underscores the need for a focus on mental health in parallel to achievement of optimal GDMT in these patients.Trial Registration: NCT01685840, https://clinicaltrials.gov/ct2/show/NCT01685840. [ABSTRACT FROM AUTHOR]

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In this observational study, we compared the prognostic ability of an electronic health record (EHR)-derived risk score, the Rothman Index (RI), automatically derived on admission, to the first 24-hour Sequential Organ Failure Assessment (SOFA) score for outcome prediction in the modern cardiac intensive care unit (CICU). We found that while the 24-hour SOFA score provided modestly superior discrimination for both in-hospital and CICU mortality, the RI upon CICU admission had better calibration for both outcomes. Given the ubiquitous nature of EHR utilization in the United States, the RI may become an important tool to rapidly risk stratify CICU patients within the ICU and improve resource allocation. [ABSTRACT FROM AUTHOR]

• South Asians living in the US exhibit markedly increased atherosclerotic disease. • South Asian ancestry is a risk enhancer in US cholesterol guidelines. • Pathophysiology may include visceral adiposity and insulin resistance. • Both genetic and cultural factors may play significant roles. • We discuss education, screening, and prevention strategies to meet the challenge. It is now well recognized that South Asians living in the US (SAUS) have a higher prevalence of atherosclerotic cardiovascular disease (ASCVD) that begins earlier and is more aggressive than age-matched people of other ethnicities. SA ancestry is now recognized as a risk enhancer in the US cholesterol treatment guidelines. The pathophysiology of this is not fully understood but may relate to insulin resistance, genetic and dietary factors, lack of physical exercise, visceral adiposity and other, yet undiscovered biologic mechanisms. In this expert consensus document, we review the epidemiology of ASCVD in this population, enumerate the challenges faced in tackling this problem, provide strategies for early screening and education of the community and their healthcare providers, and offer practical prevention strategies and culturally-tailored dietary advice to lower the rates of ASCVD in this cohort. [ABSTRACT FROM AUTHOR]

Background: Despite a temporal increase in respiratory failure in patients hospitalized with acute heart failure (HF), clinical trials have largely not reported the incidence or associated clinical outcomes for patients requiring mechanical ventilation.Methods and Results: After pooling 5 acute HF clinical trials, we used multivariable logistic regression adjusted for demographics, comorbidities, examinations, and laboratory findings to assess associations between mechanical ventilation and clinical outcomes. Among the 8296 patients, 210 (2.5%) required mechanical ventilation. Age, sex, smoking history, baseline ejection fraction, HF etiology, and the proportion of patients randomized to treatment or placebo in the original clinical trial were similar between groups (all, P > 0.05). Baseline diabetes mellitus was more common in the mechanical ventilation group (P = 0.02), but other comorbidities, including chronic lung disease, were otherwise similar (all P > 0.05). HF rehospitalization at 30 days (12.7% vs 6.6%, P < 0.001) and all-cause 60-day mortality (33.3% vs 6.1%, P < 0.001) was higher among patients requiring mechanical ventilation. After multivariable adjustment, mechanical ventilation use was associated with an increased 30-day HF rehospitalization (odds ratio 2.03; 95% confidence interval, 1.29-3.21, P = 0.002), 30-day mortality (odds ratio 10.40; 95% confidence interval, 7.22-14.98, P < 0.001), and 60-day mortality (odds ratio 7.68; 95% confidence interval, 5.50-10.74, P < 0.001). The influence of mechanical ventilation did not differ by HF etiology or baseline ejection fraction (both, interaction P > 0.20).Conclusions: Respiratory failure during an index hospitalization for acute HF was associated with increased rehospitalization and all-cause mortality. The development of respiratory failure during an acute HF admission identifies a particularly vulnerable population, which should be identified for closer monitoring. [ABSTRACT FROM AUTHOR]

Community engagement and rapid translation of findings for the benefit of patients has been noted as a major criterion for NIH decisions regarding allocation of funds for research priorities. We aimed to examine whether the presence of top NIH-funded institutions resulted in a benefit on the cardiovascular and cancer mortality of their local population. METHODS AND RESULTS: Based on the annual NIH funding of every academic medical from 1995 through 2014, the top 10 funded institutes were identified and the counties where they were located constituted the index group. The comparison group was created by matching each index county to another county which lacks an NIH-funded institute based on sociodemographic characteristics. We compared temporal trends of age-standardized cardiovascular mortality between the index counties and matched counties and states. This analysis was repeated for cancer mortality as a sensitivity analysis. From 1980 through 2014, the annual cardiovascular mortality rates declined in all counties. In the index group, the average decline in cardiovascular mortality rate was 51.5 per 100,000 population (95% CI, 46.8-56.2), compared to 49.7 per 100,000 population (95% CI, 45.9-53.5) in the matched group (P = .27). Trends in cardiovascular mortality of the index counties were similar to the cardiovascular mortality trends of their respective states. Cancer mortality rates declined at higher rates in counties with top NIH-funded medical centers (P < .001). CONCLUSIONS: Cardiovascular mortality rates have decreased with no apparent incremental benefit for communities with top NIH-funded institutions, underscoring the need for an increased focus on implementation science in cardiovascular diseases. [ABSTRACT FROM AUTHOR]

Background: Although the use of extracorporeal membrane oxygenation (ECMO) continues to increase, very little is known about how age influences the transition to definitive advanced therapies.Methods: Using the National Inpatient Sample database from 2008 to 2017, we analyzed patients supported by ECMO for cardiogenic shock and separated patients into 2 age cohorts: < 65 years and ≥ 65 years. Primary outcomes of interest included the proportion of patients undergoing orthotopic cardiac transplantation (OHT) and left ventricular assist device (LVAD) implantation.Results: Over the study period, we identified 16,132 hospitalizations of people with cardiogenic shock requiring ECMO support. Significantly fewer patients in the older group underwent OHT compared to the younger group (0.4% vs 1.2%, P < 0.001). Compared to the younger group, a lower proportion of those ≥ 65 years received an LVAD (3.7% vs 5.8%, P < 0.001). LVAD implantation increased over the study period in both age cohorts, whereas OHT increased only in the < 65 group (P < 0.05, all). After multivariable adjustment, patients in the oldest age group were still less likely to receive an LVAD (odds ratio 0.54; confidence interval: 0.43-0.69, P < 0.001) and continued to have the highest odds of in-hospital mortality (odds ratio 1.53; confidence interval : 1.39-1.69, P < 0.001).Conclusions: Survival of patients ≥ 65 years requiring ECMO for cardiogenic shock is poor and less commonly includes transition to definitive advanced therapies. Although we must stress that no patient should be denied ECMO based solely on age, we believe our results may be helpful for providers when counseling patients and their families. [ABSTRACT FROM AUTHOR]

Patients are at high risk for a recurrent cardiovascular (CV) event in the first year following acute coronary syndrome (ACS). Low-density lipoprotein cholesterol (LDL-C) is a modifiable risk factor for recurrent CV events. Despite the availability of lipid-lowering therapies (LLT), many patients fail to achieve guideline-recommended LDL-C <70 mg/dL in the year post-ACS. Early LDL-C evaluation and LLT intensification after recent ACS may reduce recurrent CV event risk. In prior Phase III trials, inclisiran plus maximally tolerated statin therapy effectively reduced LDL-C in patients with established atherosclerotic cardiovascular disease (ASCVD). As patients with an ACS within 3 months of screening were excluded from these trials, the efficacy of inclisiran in these patients is unknown. To assess the LDL-C-lowering effect of inclisiran added to usual care, vs usual care alone, in patients recently hospitalized (in-patient/out-patient) for an ACS and with LDL-C ≥70 mg/dL despite statin therapy. VICTORION-INCEPTION (NCT04873934) is a Phase IIIb, randomized, parallel-group, open-label, multicenter, United States-based trial enrolling eligible patients to receive inclisiran plus usual care or usual care (Figure). Concomitant LLT and routine LDL-C assessment is at the discretion of the managing physician to mimic real-world clinical practice. The primary endpoints are percent change from baseline in LDL-C and the proportion of patients achieving LDL-C <70 mg/dL. Key secondary endpoints include absolute change from baseline in LDL-C, absolute and percentage change in LDL-C at each post-baseline visit, the proportion of patients reaching pre-specified LDL-C targets, absolute and percentage change in other plasma lipids, the intensity of background LLT, and safety and tolerability of inclisiran. VICTORION-INCEPTION, an ongoing trial planned to complete in early 2024, will assess the effectiveness of inclisiran plus usual care for the management of patients with elevated LDL-C post-ACS despite receiving statin therapy. Yes This investigation was sponsored by Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA. Medical writing support was provided by Rebecca Dargue, PhD, BOLDSCIENCE Ltd., and was funded by Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA, in accordance with GPP 2022 guidelines. The authors had full control of the content and made the final decision on all aspects of this publication. [ABSTRACT FROM AUTHOR]

Although both obesity and coronavirus disease 2019 (COVID-19) independently induce inflammation and thrombosis, the association between obesity class and risk of thrombosis in patients with COVID-19 remains unclear. This retrospective cohort study included consecutive patients hospitalized with COVID-19 at a single institution. Patients were categorized based on obesity class. The main outcomes were venous thromboembolism (VTE) and myocardial injury, a marker of microvascular thrombosis in COVID-19. Adjustments were made for sociodemographic variables, cardiovascular disease risk factors and comorbidities. 609 patients with COVID-19 were included. 351 (58%) patients were without obesity, 110 (18%) were patients with class I obesity, 76 (12%) were patients with class II obesity, and 72 (12%) were patients with class III obesity. Patients with class I and III obesity had significantly higher risk-adjusted odds of VTE compared to patients without obesity (OR = 2.54, 95% CI: 1.05–6.14 for class I obesity; and OR = 3.95, 95% CI: 1.40–11.14 for class III obesity). Patients with class III obesity had significantly higher risk-adjusted odds of myocardial injury compared to patients without obesity (OR = 2.15, 95% CI: 1.12–4.12). Both VTE and myocardial injury were significantly associated with greater risk-adjusted odds of mortality. This study demonstrates that both macrovascular and microvascular thromboses may contribute to the elevated morbidity and mortality in patients with obesity and COVID-19. [ABSTRACT FROM AUTHOR]

We sought to examine the patterns of cardiovascular disease (CVD) mortality in varying degrees of access to exercise opportunities at county level in the United States. Access to exercise opportunities was significantly associated with adjusted CVD mortality (P < .001); higher access to exercise opportunities correlated with lower CVD mortality. Counties with lower access to exercise facilities had higher prevalence of obesity and diabetes when compared with counties with higher access (P < .001). Furthermore, the states with fewer people living in close proximity to a park had higher percentage of people not engaging in any leisure physical activity (P < .001). [ABSTRACT FROM AUTHOR]

Background: Traditional statistical approaches to prediction of outcomes have drawbacks when applied to large clinical databases. It is hypothesized that machine learning methodologies might overcome these limitations by considering higher-dimensional and nonlinear relationships among patient variables.Methods and Results: The Unified Network for Organ Sharing (UNOS) database was queried from 1987 to 2014 for adult patients undergoing cardiac transplantation. The dataset was divided into 3 time periods corresponding to major allocation adjustments and based on geographic regions. For our outcome of 1-year survival, we used the standard statistical methods logistic regression, ridge regression, and regressions with LASSO (least absolute shrinkage and selection operator) and compared them with the machine learning methodologies neural networks, naïve-Bayes, tree-augmented naïve-Bayes, support vector machines, random forest, and stochastic gradient boosting. Receiver operating characteristic curves and C-statistics were calculated for each model. C-Statistics were used for comparison of discriminatory capacity across models in the validation sample. After identifying 56,477 patients, the major univariate predictors of 1-year survival after heart transplantation were consistent with earlier reports and included age, renal function, body mass index, liver function tests, and hemodynamics. Advanced analytic models demonstrated similarly modest discrimination capabilities compared with traditional models (C-statistic ≤0.66, all). The neural network model demonstrated the highest C-statistic (0.66) but this was only slightly superior to the simple logistic regression, ridge regression, and regression with LASSO models (C-statistic = 0.65, all). Discrimination did not vary significantly across the 3 historically important time periods.Conclusions: The use of advanced analytic algorithms did not improve prediction of 1-year survival from heart transplant compared with more traditional prediction models. The prognostic abilities of machine learning techniques may be limited by quality of the clinical dataset. [ABSTRACT FROM AUTHOR]

The economics of heart failure (HF) touches all patients with HF, their families, and the physicians and health systems that care for them. HF is specifically targeted by cost-reduction and care quality initiatives from the Centers for Medicare and Medicaid Services (CMS). The changing quality assessment and payment landscape is, and will continue to be, challenging for hospitals and HF specialists as they provide care for patients with this debilitating disease. Quality-based payment systems with evolving performance metrics are replacing traditional volume-based fee-for-service models. A critical objective of quality-based models is to improve care and reduce cost, but there are few data to support decision-making on how to improve. CMS payment programs and their implications for health systems treating HF were reviewed at a symposium at the Heart Failure Society of America conference in Nashville, Tennessee on September 15, 2018. This article constitutes the proceedings from that symposium. [ABSTRACT FROM AUTHOR]

Background: Major bleeding is a frequent complication for patients with acute myocardial infarction (AMI) and is associated with significant morbidity and mortality.Objective: To develop a contemporary model for inhospital major bleeding that can both support clinical decision-making and serve as a foundation for assessing hospital quality.Methods: An inhospital major bleeding model was developed using the Acute Coronary Treatment and Intervention Outcomes Network Registry-Get With the Guidelines (ACTION Registry-GWTG) database. Patients hospitalized with AMI between January 1, 2012 and December 31, 2013 across 657 hospitals were used to create a derivation cohort (n=144,800) and a validation cohort (n=96,684). Multivariable hierarchal logistic regression was used to identify significant predictors of major bleeding. A simplified risk score was created to enable prospective risk stratification for clinical care.Results: The rate of major bleeding in the overall population was 7.53%. There were 8 significant, independent factors associated with major bleeding: presentation after cardiac arrest (OR 2.99 [2.77-3.22]); presentation in cardiogenic shock (OR 2.22 [2.05-2.40]); STEMI (OR 1.72 [1.65-1.80]); presentation in heart failure (OR 1.55 [1.47-1.63]); baseline hemoglobin less than 12 g/dL (1.55 [1.48-1.63]); heart rate (per 10 beat per minute increase) (OR 1.13 [1.12-1.14]); weight (per 10 kilogram decrease) (OR 1.12 [1.11-1.14]); creatinine clearance (per 5-mL decrease) (OR 1.07 [1.07-1.08]). The model discriminated well in the derivation (C-statistic = 0.74) and validation (C-statistic = 0.74) cohorts. In the validation cohort, a risk score for major bleeding corresponded well with observed bleeding: very low risk (2.2%), low risk (5.1%), moderate risk (10.1%), high risk (16.3%), and very high risk (25.2%).Conclusion: The new ACTION Registry-GWTG inhospital major bleeding risk model and risk score offer a robust, parsimonious, and contemporary risk-adjustment method to support clinical decision-making and enable hospital quality assessment. Strategies to mitigate risk should be developed and tested as a means to lower costs and improve outcomes in an era of alternative payment models. [ABSTRACT FROM AUTHOR]

In response to wide variation in quality and outcomes as well as escalating health care costs, the U.S. health care system is moving away from a volume-based payment system to a quality- and value-based system. Medicare, the largest insurer and payer of health care, has accelerated the movement toward value-based care with the development and implementation of myriad alternate payment models and pay-for-performance programs as part of the Affordable Care Act. Given that heart failure affects a significant number of Medicare patients and that these patients account for a disproportionate amount of health care utilization and spending, heart failure has become a focal point for these initiatives. In this article, we highlight 4 such programs beyond the Hospital Readmission Reduction Program (HRRP) which financially penalizes hospitals for excess readmissions. Specifically, we focus on Hospital Value-Based Purchasing (HVBP), Bundled Payments for Care Improvement (BPCI), the Merit-Based Incentive Payment System (MIPS), and Accountable Care Organizations (ACOs). The HVBP and BPCI programs aim to improve quality and cost efficiency primarily among patients who are hospitalized, and the MIPS program has taken similar aim in the ambulatory setting. Finally, ACOs encourage active population health management across the continuum of care as providers bear financial risk for enrolled patients. Given broader discussions about health care reform, the specific policies and programs meant to accelerate the transition from volume to value may be altered. However, the underlying drivers for reform will persist, and heart failure is a clinical condition that by comparison will be subject to greater scrutiny. [ABSTRACT FROM AUTHOR]

Contemporary patterns of care of patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) and the adoption of finerenone are not known. The FINE-REAL study (NCT05348733) is a prospective observational study in patients with CKD and T2D to provide insights into the use of the nonsteroidal mineralocorticoid receptor antagonist (MRA) finerenone in clinical practice. FINE-REAL is an international, prospective, multicenter, single-arm study enrolling approximately 5500 adults with CKD and T2D in an estimated 200 sites across 22 countries. The study is anticipated to be ongoing until 2027. The primary objective is to describe treatment patterns in patients with CKD and T2D treated with finerenone in routine clinical practice. Secondary objectives include assessment of safety with finerenone. Other endpoints include characterization of healthcare resource utilization and occurrence of newly diagnosed diabetic retinopathy or its progression from baseline in patients with existing disease. A biobank is being organized for future explorative analyses with inclusion of participants from the United States. FINE-REAL is the first prospective observational study with a nonsteroidal MRA in a population with CKD and T2D and is expected to provide meaningful insights into the treatment of CKD associated with T2D. FINE-REAL will inform decision-making with respect to initiation of finerenone in patients with CKD and T2D. • Finerenone is approved for treatment of chronic kidney disease associated with type 2 diabetes. • The FINE-REAL study will provide insights into finerenone use in clinical practice which is unknown. • Here, the design and rationale of the FINE-REAL study (NCT05348733) is described. [ABSTRACT FROM AUTHOR]

Among patients with heart failure with reduced ejection fraction (HFrEF), worsening heart failure (WHF) and ≥10-point lower fraction (EF) are two established risk factors for cardiovascular death and heart failure (HF) hospitalization [Solomon 2005]. We hypothesized that patients with both risk factors represent a small percentage of the overall HF population yet account for a disproportionately larger share of the >1 million annual HF hospitalizations in the US. The various data necessary to document the magnitude of this risk differential have been reported across a variety of studies conducted for other aims. We sought to estimate the prevalence, rate of HF hospitalization, and any excess hospitalization risk for adult HF patients and subgroups with standard-risk and high-risk HFrEF. We evaluated literature and US 2020 census data to estimate the prevalence of HF, HFrEF and a third higher-risk subgroup: EF ≤30. We then applied literature-based WHF rates [Butler 2019] to these groups. WHF was defined as having an HF event (often hospitalization, also including emergency/urgent use of IV diuretics) within the 12 prior months, excluding de novo events. Similarly, using US reported HF-related hospitalizations, we applied literature-based event rates for the same subgroups [Chang 2014, Reinhardt 2021] to determine national estimates. CV death data was excluded but assumed to have similar risk. With an estimated US prevalence of 1810 adult patients with HF per 100,000 population, we estimated HFrEF prevalence rates of 882 per 100,000 including EF ≤30 prevalence of 634 (72% of HFrEF; 35% of all HF). Within HFrEF, WHF prevalence was estimated at 168 per 100,000 including 126 having EF ≤30 (7.0% of all HF). Among 343 HF hospitalizations per 100,000 population, 263 (76.7%) were among patients with WHF. HF hospitalization rates were estimated at 206 for HFrEF overall and 158 for HFrEF with WHF, vs 161 and 124 for EF≤30 overall and EF≤30 with WHF, respectively. The higher-risk group with both WHF and EF≤30 comprised 7% of patients with HF yet 36% of all HF hospitalizations (p<0.0001), an excess risk of 416% relative to the average patient with HF (Figure). Patients with worsening HF and EF≤30 are a small proportion of the total HF population yet account for >35% of all HF hospitalizations, with >4-fold disproportionate risk of HF hospitalization compared to the average patient with HF. Improved quality, outcomes, value, and efficiency may be fostered by focusing resources towards this easily-identifiable subgroup of patients with HF, to help achieve full dose and range of GDMT treatments, with consideration of new treatment options especially when tolerability challenges arise. [ABSTRACT FROM AUTHOR]

Objectives: This study sought to define the ability of AMG 145, a monoclonal antibody directed against proprotein convertase subtilisin kexin type 9 (PCSK9), to enable subjects at high risk for major adverse cardiovascular events to achieve National Cholesterol Education Program-Adult Treatment Panel III (NCEP-ATP III) parameters for low-density lipoprotein cholesterol (LDL-C) and other lipid goals. Background: Many patients at high risk for adverse cardiovascular events are unable to achieve the NCEP-ATP III LDL-C goal of <70 mg/dl, even with high-potency statin therapy. Methods: In 282 subjects from the LAPLACE-TIMI 57 (LDL-C Assessment with PCSK9 monoclonaL Antibody Inhibition Combined With Statin thErapy-Thrombolysis In Myocardial Infarction 57) trial at high risk according to NCEP-ATP III criteria, we compared the proportion of subjects achieving the NCEP-ATP III recommended LDL-C goal of <70 mg/dl across treatment arms. Other outcomes included the triple goals of LDL-C <70 mg/dl, non-high-density lipoprotein cholesterol (HDL-C) <100 mg/dl, and apolipoprotein B (ApoB) <80 mg/dl. Results: During the dosing interval, more than 90% of subjects in both of the top dose groups every 2 weeks and every 4 weeks attained this lipid target over the dosing interval, with similar success rates for the triple lipid goal. Conclusions: PCSK9 inhibition with AMG 145 enables high-risk patients to achieve established lipid goals. If this therapy demonstrates efficacy for reducing cardiovascular events with a favorable safety profile in ongoing phase 3 trials, we believe it will have major public health implications. [ABSTRACT FROM AUTHOR]

: From 2009-2014, total index hospitalizations and annual expenditures for heart transplantation (HT) and LVAD doubled, but more contemporary trends utilization and cost are not well understood. From 2015-2018, we identified 10,435 HT and 16,455 LVAD implantation index hospitalizations from the National Inpatient Sample. Hospitalizations for both increased over the study period, but less for LVAD (HT:2235 to 2955, LVAD: 3985 to 4045). For HT, length of stay (LOS) decreased but total costs and in-hospital mortality increased, (p≤0.005, all). For LVAD implantation, LOS and inpatient mortality increased (both p≤0.005) but total costs were stable. A higher percentage of HT admissions were discharged to home compared to those for LVAD implantation (Table 1). For both cohorts, admissions of Asian patients on Medicaid were the costliest (HT: median $361,068 [interquartile range (IQR) $165,938-595,240], LVAD: $459,419 [$270,332-583,858]). Those of Hispanic patients had the highest in-hospital mortality and longest LOS, all p<0.001. Women had longer median LOS for both, but lower in-hospital mortality in HT only, all p≤0.014 (Table 2). : Hospitalization volume and in-hospital mortality increased for both, but LOS and totals costs varied for HT vs LVAD implantation. More work is needed to understand these disparities and post-discharge utilization and cost. [ABSTRACT FROM AUTHOR]

Objectives: The aim of this study was to evaluate anticoagulant use patterns and bleeding risk in a contemporary population of patients with acute coronary syndrome. Background: Current practice guidelines support the use of unfractionated heparin, low molecular weight heparin, bivalirudin, or fondaparinux in non–ST-segment elevation myocardial infarction (NSTEMI) and ST-segment elevation myocardial infarction (STEMI). Little is known about how these agents are selected in clinical practice. Methods: Between January 2007 and June 2009, data were captured for 72,699 patients with NSTEMI and 48,943 patients with STEMI at 360 U.S. hospitals for the NCDR ACTION Registry–GWTG (National Cardiovascular Data Registry Acute Coronary Treatment and Intervention Outcomes Network Registry–Get With the Guidelines). Patients were categorized based on anticoagulant strategy selected during hospitalization and their CRUSADE (Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes With Early Implementation of ACC/AHA [American College of Cardiology/American Heart Association] Guidelines) bleeding risk category. Results: At least 1 anticoagulant was administered to 66,279 patients (91.2%) with NSTEMI and 46,149 patients (94.3%) with STEMI. Among STEMI patients, unfractionated heparin was most commonly used (66%), followed by bivalirudin (14%) and low molecular weight heparin (8%). In NSTEMI patients, unfractionated heparin was also the most commonly used anticoagulant (42%), followed by low molecular weight heparin (27%) and then bivalirudin (13%). There were significant differences in anticoagulant use by age, risk factors, concomitant medications, and invasive care. There was a 5-fold difference in the rate of bleeding between patients in the lowest and highest CRUSADE bleeding risk groups, which was consistently observed in most anticoagulant groups. Conclusions: There is a wide variability in the use of anticoagulant regimens with significant differences according to baseline characteristics and concomitant therapies. Major bleeding is common, though a great degree of the variability in the rate of bleeding is largely based on differences in baseline characteristics, comorbidities, and invasive treatment strategies, rather than specific anticoagulant regimens. [Copyright &y& Elsevier]

The ability to mechanically dilate and treat stenoses in the coronary arteries opened a new chapter in cardiovascular medicine. Percutaneous coronary intervention (PCI) has been shown to improve outcomes among patients with acute coronary syndromes as well as improve symptoms among patients with stable coronary artery disease. Adjunctive antiplatelet therapy plays a critical role both in the periprocedural setting as well as in the long-term management of atherothrombosis. Over the past several years, clinical trials of novel compounds and treatment strategies have further refined our pharmacotherapeutic approach. Aspirin remains the cornerstone for antiplatelet therapy across the spectrum of ischemic heart disease. In contrast, studies of glycoprotein IIb/IIIa inhibitors suggest a more limited role, particularly when used in addition to contemporary dual antiplatelet therapy. Clopidogrel, the most widely used P2Y12 adenosine diphosphate receptor blocker—although having demonstrated efficacy in patients with ST-segment elevation myocardial infarction, non–ST-segment elevation acute coronary syndrome, and stable coronary artery disease undergoing PCI—has several limitations, including delay in onset, variability in response, and modest potency. The third-generation thienopyridine, prasugrel, as well as nonthienopyridine inhibitors of the P2Y12 receptor such as ticagrelor and cangrelor address these shortcomings, offering more potent, consistent, and rapid platelet inhibition. Prasugrel and ticagrelor led to significant reductions in adverse cardiovascular events, including cardiovascular mortality for the latter, whereas cangrelor met noninferiority compared with 600 mg of clopidogrel in patients with ACS undergoing PCI. There are myriad novel compounds at varying stages of development, including thrombin receptor antagonists whose role in the periprocedural and long-term setting will be defined through further study. Significant questions regarding antiplatelet therapy remain unanswered, including the role of genetic and platelet function testing to “tailor therapy”; the optimal duration of therapy; and the optimal mechanism to deliver high-quality, cost-effective antiplatelet therapy to all patients. [Copyright &y& Elsevier]