First Human Safety and Effectiveness Study of Defibrillation with a Novel Patch Wearable Cardioverter-Defibrillator (P-WCD).

BACKGROUND: WCDs are indicated in patients at risk of sudden cardiac arrest who are not immediate candidates for implantable defibrillator therapy. Limitations of existing WCDs include poor compliance and high false alarm rates. The Jewel is a novel patch-WCD (P-WCD) that addresses these limitations with an adhesive-based design for near-continuous wear and a machine learning algorithm designed to minimize inappropriate detections. This was a first-in-human study of the Jewel P-WCD conducted in an electrophysiology (EP) lab to determine the safety and effectiveness of the device in terminating VT/VF with a single shock. OBJECTIVE: To evaluate the safety and effectiveness of terminating VT/VF with a single shock using the Jewel P-WCD. METHODS: This was a first-in-human, prospective, single-arm, single-center study in patients scheduled for an EP procedure in which VT/VF was expected to either spontaneously occur or be induced. The Jewel P-WCD was placed on consented patients; upon confirmation of VT/VF, a single shock (150J) was delivered via the device. A group sequential design and Pocock alpha spending function was used to measure the observed proportion of successful VT/VF single-shock terminations. The endpoint was achieved if the lower confidence limit exceeded the performance goal of 62%, using a one-sided lower 97.4% exact confidence bound. RESULTS: Of 18 eligible subjects, 16 (88.9%, 97.4% confidence bound: 65.4%) were successfully defibrillated with a single shock, exceeding the primary endpoint performance goal with no adverse events. CONCLUSIONS: This first-in-human evaluation of the Jewel P-WCD demonstrated the safety and effectiveness of terminating VT/VF. REGISTRATION: URL: https://www.clinicaltrials.gov/; Unique identifier: NCT05490459.

Utilizing mobile technologies to improve physical activity and medication adherence in patients with heart failure and diabetes mellitus: Rationale and design of the TARGET-HF-DM Trial.

Heart failure (HF) and diabetes mellitus (DM) are major public health issues that place significant burden on patients and health care systems. Patients with both HF and DM are at higher risk of adverse cardiovascular and HF outcomes than those with either disease in isolation. Different antihyperglycemic medications (even within the same medication class) have conflicting results of benefit or harm in patients with established and incident HF. Recent data highlight the importance of a renewed focus on optimal pharmacotherapy for this population with DM and HF (or at risk for HF). Both HF and DM require major lifestyle modification for optimal management, in terms of both optimizing health behaviors (eg, physical activity, diet) and adherence to complex medical and self-care regimens. Mobile health (mHealth) technologies (eg, apps, wearables) are widely available in the community and may play a role in optimizing the health status of patients; however, there is limited and conflicting information on whether such technologies are actually beneficial in at-risk populations. In this article, we summarize current strategies, including mobile health interventions, to improve physical activity levels, drug adherence, and outcomes in patients with DM, HF, or both and describe the design and rationale for the Technologies to improve drug Adherence and Reinforce Guideline based Exercise Targets in patients with heart Failure and Diabetes Mellitus trial, which is designed to test the efficacy of using mHealth technology to improve health behaviors and outcomes in this high-risk population.

Leveraging Behavioral Economics to Improve Heart Failure Care and Outcomes.

Behavioral challenges are often present in human illness, so behavioral economics is increasingly being applied in healthcare settings to better understand why patients choose healthy or unhealthy behaviors. The application of behavioral economics to healthcare settings parallels recent shifts in policy and reimbursement structures that hold providers accountable for outcomes that are dependent on patient behaviors. Numerous studies have examined the application of behavioral economics principles to policy making and health behaviors, but there are limited data on applying these concepts to the management of chronic conditions, such as heart failure (HF). Given its increasing prevalence and high associated cost of care, HF is a paradigm case for studying novel approaches to improve health care; therefore, if we can better understand why patients with HF make the choices they do, then we may be more poised to help them manage their medications, influence daily behaviors, and encourage healthy decision making. In this article, we will give a brief explanation of the core behavioral economics concepts that apply to patients with HF. We will also examine how to craft these concepts into tools such as financial incentives and social networks that may improve the management of patients with HF. We believe that behavioral economics can help us understand barriers to change, encourage positive behaviors, and offer additional approaches to improving the outcomes of patients with HF.

Medication Initiation Burden Required to Comply With Heart Failure Guideline Recommendations and Hospital Quality Measures.

BACKGROUND: Guidelines for heart failure (HF) recommend prescription of guideline-directed medical therapy before hospital discharge; some of these therapies are included in publicly reported performance measures. The burden of new medications for individual patients has not been described. METHODS AND RESULTS: We used Get With The Guidelines-HF registry data from 2008 to 2013 to characterize prescribing, indications, and contraindications for angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, ß-blockers, aldosterone antagonists, hydralazine/isosorbide dinitrate, and anticoagulants. The difference between a patient's medication regimen at hospital admission and that recommended by HF quality measures at discharge was calculated. Among 158 922 patients from 271 hospitals with a primary discharge diagnosis of HF, initiation of angiotensin-converting enzyme inhibitors or angiotensin receptor blockers was indicated in 18.1% of all patients (55.5% of those eligible at discharge were not receiving angiotensin-converting enzyme inhibitors or angiotensin receptor blockers at admission), ß-blockers in 20.3% (50.5% of eligible), aldosterone antagonists in 24.1% (87.4% of eligible), hydralazine/isosorbide dinitrate in 8.6% (93.1% of eligible), and anticoagulants in 18.0% (58.0% of eligible). Cumulatively, 0.4% of patients were eligible for 5 new medication groups, 4.1% for 4 new medication groups, 9.4% for 3 new medication groups, 10.1% for 2 new medication groups, and 22.7% for 1 new medication group; 15.0% were not eligible for new medications because of adequate prescribing at admission; and 38.4% were not eligible for any medications recommended by HF quality measures. Compared with newly indicated medications (mean, 1.45 ± 1.23), actual new prescriptions were lower (mean, 1.16 ± 1.00). CONCLUSIONS: A quarter of patients hospitalized with HF need to start >1 medication to meet HF quality measures. Systems for addressing medication initiation and managing polypharmacy are central to HF transitional care.

The Obesity and Heart Failure Epidemics Among African Americans: Insights From the Jackson Heart Study.

BACKGROUND: Higher rates of obesity and heart failure have been observed in African Americans, but associations with mortality are not well-described. We examined intermediate and long-term clinical implications of obesity in African Americans and associations between obesity and all-cause mortality, heart failure, and heart failure hospitalization. METHODS AND RESULTS: We conducted a retrospective analysis of a community sample of 5292 African Americans participating in the Jackson Heart Study between September 2000 and January 2013. The main outcomes were associations between body mass index (BMI) and all-cause mortality at 9 years and heart failure hospitalization at 7 years using Cox proportional hazards models and interval development of heart failure (median 8 years' follow-up) using a modified Poisson model. At baseline, 1406 (27%) participants were obese and 1416 (27%) were morbidly obese. With increasing BMI, the cumulative incidence of mortality decreased (P= .007), whereas heart failure increased (P < .001). Heart failure hospitalization was more common among morbidly obese participants (9.0%; 95% confidence interval [CI] 7.6-11.7) than among normal-weight patients (6.3%; 95% CI 4.7-8.4). After risk adjustment, BMI was not associated with mortality. Each 1-point increase in BMI was associated with a 5% increase in the risk of heart failure (hazard ratio 1.05; 95% CI 1.03-1.06; P < .001) and the risk of heart failure hospitalization for BMI greater than 32 kg/m(2) (hazard ratio 1.05; 95% CI 1.03-1.07; P < .001). CONCLUSIONS: Obesity and morbid obesity were common in a community sample of African Americans, and both were associated with increased heart failure and heart failure hospitalization.

Variation in performance measure criteria significantly affects cardiology practice rankings: Insights from the National Cardiovascular Data Registry's Practice Innovation and Clinical Excellence Registry.

BACKGROUND: Million Hearts is a national initiative to prevent 1 million heart attacks and strokes over 5 years by improving cardiovascular prevention. An important tool in the success of programs like Million Hearts is public ranking on the quality of practices, yet different measures may provide different rankings, so the true quality of practices is difficult to discern. We evaluated the quality of ambulatory cardiology care using performance measure metrics. METHODS: We compared rankings of practices participating in the National Cardiovascular Data Registry's Practice Innovation and Clinical Excellence Registry using measures from (1) the physician quality reporting system and (2) the American College of Cardiology/American Heart Association/Physician Consortium for Performance Improvement. We compared achievement rates for measures between the 2 frameworks and determined correlations in rankings using Spearman correlation coefficients. RESULTS: From January 1, 2008 to December 31, 2012, there were 1,711,326 patients enrolled from 111 US practices. Among eligible patients, the physician quality reporting system and American College of Cardiology/American Heart Association/Physician Consortium for Performance Improvement measures were achieved in 76.1% versus 77.4% for antiplatelet prescription (P < .001), 68.3% versus 90.8% for blood pressure control (P < .001), 26.9% versus 43.4% for cholesterol control (P < .001), and 37.4% versus 40.6% for smoking cessation (P = .383). Practice rankings were strongly correlated for antiplatelet prescription (correlation coefficient 0.98) and cholesterol control (0.92) but poorly correlated for blood pressure control (0.39) and smoking cessation (0.22). CONCLUSIONS: Evaluation of preventive care and individual practice rankings vary significantly depending on how measures are defined. Publicly reported measures need to be validly associated with outcomes to avoid incorrectly evaluating practice performance and failing to achieve public health goals.

Thinking Outside the Box: Treating Acute Heart Failure Outside the Hospital to Improve Care and Reduce Admissions.

The management of acute heart failure is shifting toward treatment approaches outside of a traditional hospital setting. Many heart failure providers are now treating patients in less familiar health care settings, such as acute care clinics, emergency departments, and skilled nursing facilities. In this review we describe the current pressures driving change in the delivery of acute heart failure and summarize the evidence regarding treatments for acute heart failure outside of the inpatient setting. We also provide considerations for the design of future treatment strategies to be implemented in alternative care settings.

Associations between atrial fibrillation and early outcomes of patients with heart failure and reduced or preserved ejection fraction.

BACKGROUND: The relative impact of atrial fibrillation on early outcomes of patients with heart failure with reduced or preserved ejection fraction (EF) is unknown. METHODS: We conducted a retrospective cohort study of clinical registry data linked to Medicare claims for patients with heart failure with reduced or preserved EF stratified by presence of atrial fibrillation at admission. Outcomes of interest were all-cause mortality and readmission at 30days. We used Kaplan-Meier methods to estimate mortality and calculated cumulative incidence estimates of readmission. We used Cox proportional hazards models to examine associations between atrial fibrillation and 30-day outcomes. RESULTS: Among 66,357 patients admitted to 283 hospitals between January 2001 and March 2006, 46% had atrial fibrillation (44% of patients with reduced EF and 48% of patients with preserved EF). After adjustment for other patient characteristics, atrial fibrillation was associated with a modestly higher risk of 30-day mortality (HR, 1.08; 95% CI, 1.03-1.14) and readmission (HR, 1.06; 95% CI, 1.02-1.11). In subgroup analyses, atrial fibrillation was associated with a higher risk of 30-day mortality (HR, 1.16; 95% CI, 1.08-1.25) among patients with preserved EF but not among patients with reduced EF. The association of atrial fibrillation with readmission did not differ by heart failure type (P=.37 for the interaction). CONCLUSIONS: Atrial fibrillation was associated with higher 30-day mortality among patients with heart failure with preserved EF but not reduced EF. The association of atrial fibrillation with 30-day readmission was modest and did not differ by heart failure type.

Current quality of cardiovascular prevention for Million Hearts: an analysis of 147,038 outpatients from The Guideline Advantage.

BACKGROUND: Million Hearts is a national initiative to prevent 1 million heart attacks and strokes over 5 years. The degree to which outpatient providers are controlling risk factors has not been fully described. METHODS: We examined adherence to the Million Hearts clinical quality measures using The Guideline Advantage, a nationwide quality improvement program for outpatient care. Specifically, we determined the proportion of patients with (1) ischemic vascular disease who were prescribed an antiplatelet drug; (2) hypertension whose blood pressure was controlled; (3) diabetes mellitus whose most recent low-density lipoprotein cholesterol level was <100 mg/dL; and 4) a tobacco use screening and who received a smoking cessation intervention as needed. RESULTS: From January 1, 2010, to March 31, 2012, there were 147,038 patients enrolled from 25 US practices. At the practice level, antiplatelet prescription ranged from 50.0% to 82.3% (median 71.9%, interquartile range [IQR] 66.7-82.1), hypertension control ranged from 48.6% to 75.3% (median 66.6%, IQR 60.1-70.9), hyperlipidemia control among patients with diabetes mellitus ranged from 53.3% to 100.0% (median 75.8%, IQR 65.8-83.0), and tobacco use screening and intervention ranged from 31.0% to 98.8% (median 79.8%, IQR 72.0-83.2). Black and people of color races were associated with a lower likelihood of blood pressure control and cholesterol control. Female gender was associated with a lower likelihood of antiplatelet prescription and cholesterol control. CONCLUSIONS: Compliance with quality measures for the Million Hearts initiative varies widely and is notable for racial and gender disparities. Our findings identify multiple opportunities to improve the quality of cardiovascular prevention.

Outcomes in patients with heart failure with preserved, borderline, and reduced ejection fraction in the Medicare population.

BACKGROUND: Studies on outcomes among patients with heart failure (HF) with preserved left ventricular ejection fraction (HFpEF), borderline left ventricular ejection fraction (HFbEF), and reduced left ventricular ejection fraction (HFrEF) remain limited. We sought to characterize mortality and readmission in patients with HF in the contemporary era. METHODS: Get With The Guidelines-HF was linked to Medicare data for longitudinal follow-up. Patients were grouped into HFpEF (left ventricular ejection fraction [EF] ≥ 50%), HFbEF (40% ≤ EF < 50%), and HFrEF (EF < 40%). Multivariable models were constructed to examine the relationship between EF and outcomes at 30 days and 1 year and to study trends over time. RESULTS: A total of 40,239 patients from 220 hospitals between 2005 and 2011 were included in the study: 18,897 (47%) had HFpEF, 5,626 (14%) had HFbEF, and 15,716 (39%) had HFrEF. In crude survival analysis, patients with HFrEF had slightly increased mortality compared with HFbEF and HFpEF. After risk adjustment, mortality at 1 year was not significantly different for HFrEF, HFbEF, and HFpEF (HFrEF vs HFpEF, hazard ratio [HR] 1.040 [95% CI 0.998-1.084], and HFbEF vs HFpEF, HR 0.967 [95% CI 0.917-1.020]). Patients with HFpEF had increased risk of all-cause readmission compared with HFrEF. Conversely, risk of cardiovascular and HF readmissions were higher in HFrEF and HFbEF compared with HFpEF. CONCLUSIONS: Among patients hospitalized with HF, patients with HFpEF and HFbEF had slightly lower mortality and higher all-cause readmission risk than patients with HFrEF, although the mortality differences did not persist after risk adjustment. Irrespective of EF, these patients experience substantial mortality and readmission highlighting the need for new therapeutic strategies.

Adherence and persistence in the use of warfarin after hospital discharge among patients with heart failure and atrial fibrillation.

BACKGROUND: Postdischarge adherence and long-term persistence in the use of warfarin among patients with heart failure and atrial fibrillation without contraindications have not been fully described. METHODS AND RESULTS: We identified patients with heart failure and atrial fibrillation who were ≥ 65 years old, eligible for warfarin, and discharged home from hospitals in the Get With the Guidelines-Heart Failure registry from January 1, 2006, to December 31, 2009. We used linked Medicare prescription drug event data to measure adherence and persistence. The main outcome measures were rates of prescription at discharge, outpatient dispensing, discontinuation, and adherence as measured by the medication possession ratio. We hypothesized that adherence to warfarin would differ according to whether patients received the prescription at discharge. Among 2,691 eligible patients, 1,856 (69.0%) were prescribed warfarin at discharge. Patients prescribed warfarin at discharge had significantly higher prescription fill rates within 90 days (84.5% vs 12.3%; P < .001) and 1 year (91.6% vs 16.8%; P < .001) and significantly higher medication possession ratios (0.78 vs 0.63; P < .001). Among both previous nonusers and existing users, fill rates at 90 days and 1 year and possession ratios were significantly higher among those prescribed warfarin at discharge. CONCLUSIONS: One-third of eligible patients with heart failure and atrial fibrillation were not prescribed warfarin at discharge from a heart failure hospitalization, and few started therapy as outpatients. In contrast, most patients who were prescribed warfarin at discharge filled the prescription within 90 days and remained on therapy at 1 year.

Conversion of cardiovascular conference abstracts to publications.

BACKGROUND: The transition of scientific knowledge from discovery into practice is less than ideal. A key step in this translation occurs when presentations from major meetings are published in peer-reviewed literature, yet the completeness and speed of this process are not known. We performed a systematic and automated evaluation of rates, timing, and correlates of publication from scientific abstracts presented at 3 major cardiovascular conferences. METHODS AND RESULTS: Using an automated computer algorithm, we searched the ISI Web of Science to identify peer-reviewed publications of abstracts presented at the American Heart Association (AHA), American College of Cardiology (ACC), and European Society of Cardiology (ESC) scientific sessions from 2006 to 2008. We compared abstract publication rates and journal impact factor between the 3 meetings using multivariable logistic regression modeling. From 2006 to 2008, 11 365, 5005, and 10 838 abstracts were presented at the AHA, ACC, and ESC meetings, respectively. Overall, 30.6% of presented abstracts were published within 2 years of the conference; ranging from 34.5% for AHA to 29.5% for ACC to 27.0% for ESC (P<0.0001). Five years after conference presentation in 2005, these rates had risen slightly to 49.7% for AHA, 42.6% for ACC, and 37.6% for ESC (P<0.0001). After adjustment for abstract characteristics and contributing countries, abstracts presented at the AHA meeting remained more likely for publication relative to the ESC (adjusted odds ratio, 1.24; 95% confidence interval, 1.16-1.34) and the ACC (adjusted odds ratio, 1.20; 95% confidence interval, 1.11-1.29). Median impact factors for subsequent publications varied from 4.8 (interquartile range, 3.8-10.1) for AHA to 4.0 (interquartile range, 3.1-7.5) for ACC and 3.9 (quartile 1-3, 2.5-5.8) for ESC (P for difference between groups <0.01). Clinical science and population science were less likely to be published compared with basic science. CONCLUSIONS: One third of abstracts were translated into publications by 2 years after presentation and less than one half by 5 years after presentation. Our findings suggest that efforts to understand the barriers to publication and to facilitate the rapid dissemination of new knowledge are needed to speed up the transition of scientific discovery into clinical practice.

Rescuing clinical trials in the United States and beyond: a call for action.

Numerous challenges-financial, regulatory, and cultural-are hindering US participation and performance in multinational clinical trials. Consequently, it is increasingly unclear how the results of these trials should be applied to American patients, practice patterns, and systems of care. Both incremental and transformative changes are needed to revitalize US participation as well as the broader clinical trial enterprise. To promote consensus around the solutions needed to address the adverse trends in clinical research, the Duke Clinical Research Institute convenedstakeholders from academia, industry, and government. article summarizes the proceedings of this meeting and addresses: (1) adverse trends in the United States and multinational clinical trials, (2) the key issues that underlie these adverse trends, and (3) potential solutions to these problems.

Relationship between sex, ejection fraction, and B-type natriuretic peptide levels in patients hospitalized with heart failure and associations with inhospital outcomes: findings from the Get With The Guideline-Heart Failure Registry.

BACKGROUND: In heart failure (HF), there are known differences in plasma B-type natriuretic peptide (BNP) levels between reduced and preserved ejection fraction (EF), but few HF studies have explored sex differences. We sought to evaluate the relationship between sex, EF, and BNP in HF patients and determine prognostic significance of BNP as it relates to sex and EF. METHODS: We included hospitals in Get With The Guidelines-Heart Failure that admitted 99,930 HF patients with reduced (EF <40%), borderline (EF 40%-49%), or preserved (EF ≥50%) EF. The primary end point was inhospital mortality. Multivariate models were used to compute odds ratios while accounting for hospital clustering. RESULTS: There were 47,025 patients with reduced (37% female), 13,950 with borderline (48% female), and 38,955 with preserved (65% female) EF. Women compared with men had higher admission median BNP levels with the greatest difference among reduced EF and smallest difference among preserved EF (median BNP in women vs men: EF reduced 1,259 vs 1,113 pg/mL, borderline 821 vs 732 pg/mL, and preserved 559 vs 540 pg/mL; P < .001 all comparisons). Ejection fraction and sex were independently associated with BNP. Inhospital mortality was 2.7%, and patients above the median BNP level had higher mortality than those below. After adjusting for over 20 clinical variables, the ability of BNP to predict inhospital mortality was similar among all subgroups (P for heterogeneity = .47). CONCLUSIONS: In a large registry, we found that despite sex/EF differences in BNP values, there was no significant difference in the ability of BNP to predict inhospital mortality among these subgroups.

Performance measures to promote quality improvement in sudden cardiac arrest prevention and treatment.

Sudden cardiac arrest (SCA) is one of the most impactful public health problems in the United States. Despite the progress made in reducing the number of cardiac deaths, the incidence of sudden cardiac death remains high. Studies of life-saving interventions for prevention and treatment of SCA, like ß-blockers, aldosterone antagonists, implantable cardioverter defibrillator therapy, automated external defibrillators, and cardiopulmonary resuscitation, have brought to light substantial underutilization, variations in care, and disparities. Thus, a comprehensive systems-based approach to addressing these gaps in care should be implemented. In addition to educating stakeholders about SCA and its prevention and developing tools that could help physicians identify patients who could benefit from primary prevention of SCA, robust performance measures with strong, evidence-based association between process performance and patient outcomes are needed. In this article, we review the burden of SCA and highlight the need to develop performance measures related to the prevention and treatment of SCA.

Clinical effectiveness of anticoagulation therapy among older patients with heart failure and without atrial fibrillation: findings from the ADHERE registry linked to Medicare claims.

BACKGROUND: Patients with heart failure are at higher risk for thromboembolic events, even in the absence of atrial fibrillation, but the effect of anticoagulation therapy on outcomes is uncertain. METHODS AND RESULTS: With data from a clinical registry linked to Medicare claims, we estimated the adjusted associations between anticoagulation and 1-year outcomes with the use of inverse probability of treatment weighting. Eligible patients had an ejection fraction ≤35%, had no concurrent atrial fibrillation, were alive at discharge, and had not received anticoagulation therapy before admission. Of 13,217 patients in 276 hospitals, 1,140 (8.6%) received anticoagulation therapy at discharge. Unadjusted rates of thromboembolic events and major adverse cardiovascular events did not differ by receipt of anticoagulation therapy. Patients discharged on anticoagulation therapy had lower unadjusted rates of all-cause mortality (27.2% vs 32.3%; P < .001) and readmission for heart failure (29.4% vs 35.4%; P < .001) and higher rates of bleeding events (5.2% vs 2.8%; P < .001). After adjustment for probability of treatment and discharge medications, there were no differences in all-cause mortality (hazard ratio 0.92; 95% confidence interval 0.80-1.06) or readmission for heart failure (0.91, 0.81-1.02), but patients receiving anticoagulation therapy were at higher risk for bleeding events (2.09, 1.47-2.97). CONCLUSIONS: Anticoagulation therapy at discharge is infrequent among older patients with heart failure and without atrial fibrillation. There were no statistically significant propensity-weighted associations between anticoagulation therapy and 1-year outcomes, except for a higher risk of bleeding.

Medical resource use, costs, and quality of life in patients with acute decompensated heart failure: findings from ASCEND-HF.

BACKGROUND: The Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure (ASCEND-HF) randomly assigned 7,141 participants to nesiritide or placebo. Dyspnea improvement was more often reported in the nesiritide group, but there were no differences in 30-day all-cause mortality or heart failure readmission rates. We compared medical resource use, costs, and health utilities between the treatment groups. METHODS AND RESULTS: There were no significant differences in inpatient days, procedures, and emergency department visits reported for the first 30 days or for readmissions to day 180. EQ-5D health utilities and visual analog scale ratings were similar at 24 hours, discharge, and 30 days. Billing data and regression models were used to generate inpatient costs. Mean length of stay from randomization to discharge was 8.5 days in the nesiritide group and 8.6 days in the placebo group (P = .33). Cumulative mean costs at 30 days were $16,922 (SD $16,191) for nesiritide and $16,063 (SD $15,572) for placebo (P = .03). At 180 days, cumulative costs were $25,590 (SD $30,344) for nesiritide and $25,339 (SD $29,613) for placebo (P = .58). CONCLUSIONS: The addition of nesiritide contributed to higher short-term costs and did not significantly influence medical resource use or health utilities compared with standard care alone.

Lipid-lowering treatment among older patients with atherosclerotic cardiovascular disease.

BACKGROUND: The contemporary uptake of lipid-lowering therapies (LLT), including more intensive treatment with high-intensity statins and non-statin LLT, among U.S. older adults (≥75 years old) with ASCVD is unknown. METHODS: In this multicenter retrospective cohort study of a large geographically diverse sample of commercially insured U.S. older adults with ASCVD, we assessed treatment with LLT. Secondary measures included LDL-C above target ≥70 mg/dl, persistence and adherence to therapy. RESULTS: Treatment with statins, high-intensity statins, ezetimibe, and PCSK9 inhibitors was assessed in 194,503 older adults (49.9% female) with known ASCVD on January 31st, 2019. 49.3% of older adults with ASCVD were on any statin, with 16.6% receiving a high-intensity statin and 32.7% on low-or moderate-intensity statins. Treatment with ezetimibe (2.4%) or PCSK9 inhibitors (0.24%) was rare and 62.6% of the overall cohort had an LDL-C above target at ≥70 mg/dl. Patients on high-intensity statins were more frequently male, had a diagnosis of coronary artery disease, and were more frequently seen by a cardiologist compared with those on low-or moderate-intensity statins and untreated individuals (p < 0.0001). The majority of older adults on high-intensity statins remained on therapy at 12 months (91.9%) and 85.7% had ≥75% adherence to treatment. CONCLUSIONS: Less than half of eligible older adults with ASCVD are on statins and only a minority of patients are receiving more intensive lipid-lowering to improve outcomes.

B-type natriuretic peptide level and postdischarge thrombotic events in older patients hospitalized with heart failure: insights from the Acute Decompensated Heart Failure National Registry.

BACKGROUND: Patients hospitalized with heart failure (HF) have elevated B-type natriuretic peptide (BNP) levels and increased risk for thromboembolic events. Associations between BNP level and thromboembolic events in patients with HF without atrial fibrillation (AF) are not well studied. METHODS: We linked data from the ADHERE registry for 2003 through 2006 with Medicare claims to identify patients ≥65 years who were hospitalized with HF, did not have AF, and did not receive warfarin at discharge. We estimated rates of all-cause mortality, thromboembolic events, myocardial infarction (MI), and stroke using Kaplan-Meier methods and the cumulative incidence function. We used Cox models to assess associations between log BNP level and each outcome after adjustment for potential confounders. RESULTS: The study population included 11,679 patients from 146 sites. Patients in the highest quartile of BNP level were older and more often male and African American. They had higher rates of coronary artery disease, renal insufficiency, and peripheral vascular disease and lower rates of diabetes mellitus and chronic obstructive pulmonary disease. After multivariable adjustment, each 30% increase in BNP level was associated with increased risks of death (hazard ratio 1.07, 95% CI 1.05-1.08) and MI (1.07, 1.04-1.10) but not thromboembolism or stroke. CONCLUSION: Higher BNP level upon admission with HF among older patients without AF was associated with increased risks of MI and mortality; however, higher BNP level was not associated with subsequent thromboembolism or stroke.

High-Intensity Statin Use Among Patients With Atherosclerosis in the U.S.

BACKGROUND: Preventive therapy among patients with established atherosclerotic cardiovascular disease (ASCVD) is generally underused. Whether new guideline recommendations and a focus on implementation have improved the use of high-intensity statins is unknown. OBJECTIVES: This study sought to evaluate the patterns and predictors of statin use among patients with ASCVD. METHODS: In this retrospective cohort study, pharmacy and medical claims data from a commercial health plan were queried for patients with established ASCVD between January 31, 2018, and January 31, 2019. Statin use on an index date of January 31, 2019, was evaluated, as was 12-month adherence and discontinuation. Multivariable logistic regression was used to determine independent associations with statin use of varying intensities. RESULTS: Of the 601,934 patients with established ASCVD, 41.7% were female, and the mean age was 67.5 ± 13.3 years. Overall, 22.5% of the cohort were on a high-intensity statin, 27.6% were on a low- or moderate-intensity statin, and 49.9% were not on any statin. In multivariable analysis, younger patients, female patients, and those with higher Charlson comorbidity score were less likely to be prescribed any statin. Among statin users, female patients, older patients, and those with peripheral artery disease were less likely to be on a high-intensity formulation, whereas a cardiology encounter in the prior year increased the odds. The majority of high-intensity stain users achieved high levels of adherence. CONCLUSIONS: Substantial underuse of statins persists in a large, insured, and contemporary cohort of patients with ASCVD from the United States. In particular, concerning gaps in appropriate statin use remain among younger patients, women, and those with noncoronary ASCVD.