Real-World Insights into Evolocumab Use in Patients with Hyperlipidemia Across Five Countries: Analysis from the ZERBINI Study.

INTRODUCTION: This study characterizes patients receiving evolocumab in clinical practice and assesses treatment effectiveness, safety and persistence outcomes across five countries. METHODS: This retrospective and prospective observational study enrolled patients initiated on evolocumab during August 2017 to July 2019 at 49 sites across Canada, Mexico, Colombia, Saudi Arabia and Kuwait. Medical records data were extracted within 6 months prior to (baseline) and every 3 months for 12 months post evolocumab initiation and reported as available. RESULTS: A total of 578 patients were enrolled (40.1% female, median age 60 [interquartile range (IQR) 51-68] years); 83.7% had atherosclerotic cardiovascular disease and/or familial hypercholesterolemia. Median low-density lipoprotein cholesterol (LDL-C) at baseline was 3.4 (IQR 2.7-4.2) mmol/L (131.5 [IQR 104.4-162.4] mg/dL), with 75.6% of patients receiving a statin (59.2% high intensity). Compared to baseline, the median lowest LDL-C was reduced by 70.2% and remained stable over 12 months of treatment. Guideline-recommended LDL-C thresholds < 1.8, < 1.4 and < 1.0 mmol/L (< 70, < 55 and < 40 mg/dL) were achieved by 75.3%, 63.6% and 47.4% of patients. LDL-C outcomes were consistent across high- and very high-risk patients. Background lipid-lowering therapy remained relatively stable. No serious treatment-emergent adverse events were reported, and persistence to evolocumab was 90.2% at 12 months. CONCLUSION: These findings provide real-world evidence that evolocumab use is in accordance with its international guideline-recommended place in dyslipidemia therapy, as well as confirmation of its effectiveness and safety in a heterogeneous population. Evolocumab can address a healthcare gap in the management of dyslipidemia by increasing the proportion of patients achieving LDL-C goals recommended to lower cardiovascular risk.

Geographic variations in lipid-lowering therapy utilization, LDL-C levels, and proportion retrospectively meeting the ACC/AHA very high-risk criteria in a real-world population of patients with major atherosclerotic cardiovascular disease events in the United States.

OBJECTIVE: We assessed national- and state-level geographic variations among patients with a history of ≥1 major atherosclerotic cardiovascular disease (ASCVD) event in: (1) the proportion of patients with retrospectively identified 2018 American College of Cardiology/American Heart Association guideline very high-risk (VHR) ASCVD criteria; (2) utilization of guideline-directed lipid-lowering therapy (LLT); and (3) the proportion of patients with persistent low-density lipoprotein cholesterol (LDL-C) elevations despite statin and/or ezetimibe use. METHODS: A retrospective cohort study using the Prognos LDL-C database linked to IQVIA longitudinal medical and prescription claims databases. The study period was from January 01, 2011, to November 30, 2019 and the index period was from January 01, 2016, to November 30, 2019; the index date was defined as the most recent LDL-C test during the index period. The study included patients aged ≥18 years at index who had a measured LDL-C level during the index period and had ≥1 inpatient/outpatient claim for ASCVD during the 5-year pre-index period. RESULTS: Of patients with any ASCVD (N=4652,468), 1537,514 (33.1%) patients had ≥1 major ASCVD event. Among patients with ≥1 major ASCVD event, the VHR ASCVD criteria were retrospectively identified in 1139,018 (74.1%) patients; Hawaii had the highest (81.7%) and Colorado the lowest (65.0%) proportion of these patients. Nationally, 48.8% and 50.2% of patients with ≥1 major ASCVD event and retrospectively identified VHR ASCVD criteria, respectively, had current LLT use; Massachusetts and Colorado had the highest and lowest proportions, respectively. After standardizing for age and sex, 57.3% and 58.8% of patients with ≥1 major ASCVD event and retrospectively identified VHR ASCVD criteria, respectively, had LDL-C ≥70 mg/dL (≥1.8 mmol/L) despite statin and/or ezetimibe use, with substantial state-level variations observed. CONCLUSIONS: The study highlights high rates of elevated LDL-C and pervasive underuse of LLT in health-insured patients with a history of major ASCVD events treated in the United States, with state-level geographic variations observed.

Lipid Testing Trends in the US Before and After the Release of the 2013 Cholesterol Treatment Guidelines.

BACKGROUND: The 2013 ACC/AHA cholesterol treatment guidelines removed the recommendation to treat adults at risk of cardiovascular disease to goal levels of low-density lipoprotein cholesterol (LDL-C). We anticipated that the frequency of LDL-C testing in clinical practice would decline as a result. To test this hypothesis, we evaluated the frequency of LDL-C testing before and after the guideline release. METHODS: We used the MarketScan® Commercial and Medicare Supplemental claims data (1/1/2007-12/31/2016) to identify four cohorts: 1) statin initiators (any intensity), 2) high-intensity statin initiators, 3) ezetimibe initiators, and 4) patients at very high cardiovascular risk (≥2 hospitalizations for myocardial infarction or ischemic stroke, with prevalent statin use). Rates of LDL-C testing by calendar year quarter were estimated for each cohort. To estimate rates in the absence of a guideline change, we fit a time-series model to the pre-guideline rates and extrapolated to the post-guideline period, adjusting for covariates, seasonality, and time trend. RESULTS: Pre- and post-guideline rates (LDL-C tests per 1,000 persons per quarter) were 248 and 235, respectively, for 3.9 million statin initiators; 263 and 246 for 1.3 million high-intensity statin initiators; 277 and 261 for 323,544 ezetimibe initiators; and 180 and 158 for 42,108 very high-risk patients. For all cohorts, observed post-guideline rates were similar to model-predicted rates. On average, the difference between observed and predicted rates was 8.5 for patients initiating any statin; 2.6 for patients initiating a high-intensity statin; 11.4 for patients initiating ezetimibe, and -0.5 for high-risk patients. CONCLUSION: We observed no discernible impact of the release of the 2013 ACC/AHA guidelines on LDL-C testing rates. Rather, there was a gradual decline in testing rates starting prior to the guideline change and continuing throughout the study period. Our findings suggest that the guidelines had little to no impact on use of LDL-C testing.

Trends in statin utilization among adults with severe peripheral artery disease including critical limb ischemia in an integrated healthcare delivery system.

Evidence suggests that statin therapy in patients with peripheral artery disease (PAD) is beneficial yet use remains suboptimal. We examined trends in statin use, intensity, and discontinuation among adults aged ⩾ 40 years with incident severe PAD and a subset with critical limb ischemia (CLI) between 2002 and 2015 within an integrated healthcare delivery system. Discontinuation of statin therapy was defined as the first 90-day gap in treatment within 1 year following PAD diagnosis. We identified 11,059 patients with incident severe PAD: 31.1% (n = 3442) with CLI and 68.9% (n = 7617) without CLI. Mean (SD) age was 68.6 (11.3) years, 60.5% were male, 54.2% white, 23.2% Hispanic, and 16.2% black. Statin use in the year before diagnosis increased from 50.4% in 2002 to 66.0% in 2015 (CLI: 43.7% to 68.0%; without CLI: 53.1% to 64.2%, respectively). The proportion of patients on high-intensity statins increased from 7.3% in 2002 to 41.9% in 2015 (CLI: 7.2% to 39.4%; without CLI: 7.4% to 44.2%, respectively). Of the 40.5% (n = 4481) who were not on a statin in the year before diagnosis, 13.5% (n = 607) newly initiated therapy within 1 month (CLI: 10.1% (n = 150); without CLI: 15.3% (n = 457)). Following diagnosis, 12.5% (n = 660) discontinued statin therapy within 1 year (CLI: 15.5% (n = 202); without CLI: 11.5% (n = 458)). Although use of statins increased from 2002 to 2015, a substantial proportion of the overall PAD and CLI subpopulation remained untreated with statins, representing a significant treatment gap in a population at high risk for cardiovascular events and adverse limb outcomes.

Gender Disparities in Health Resource Utilization in Patients with Atherosclerotic Cardiovascular Disease: A Retrospective Cross-Sectional Study.

INTRODUCTION: Gender disparities in access to healthcare have been documented, including disparities in access to care for cardiovascular diseases (CVDs). Disparities in access to cardiologists could disadvantage some patients to the newer lipid-lowering proprotein convertase subtilisin/kexin type 9 inhibitor (PCSK9i) antibodies, as utilization management criteria for PCSK9is often require step therapy with statins and/or ezetimibe and prescription by a cardiologist. To assess whether these utilization management criteria disproportionally limit access to patients with certain characteristics, we assessed the use of cardiologist care and receipt of statin and/or ezetimibe prescriptions from a cardiologist by gender and other patient demographic and clinical characteristics. METHODS: This cross-sectional study used administrative claims data from Inovalon's Medical Outcomes Research for Effectiveness and Economics Registry (MORE2 Registry®) for patients enrolled in commercial and Medicare Advantage healthcare plans from January 1, 2014, through December 31, 2014. Provider data from the registry were linked to individual demographic and administrative claims data. Logistic regression models were used to assess characteristics associated with outpatient visits to a cardiologist and receipt of a prescription for statin and/or ezetimibe from a cardiologist. RESULTS: Data from 39,322 patients in commercial plans and 261,898 patients with Medicare Advantage were analyzed. Female gender (vs male) was associated with a significantly lower likelihood of visiting a cardiologist for patients in commercial plans (odds ratio [OR] 0.85; 95% confidence limit [CL] 0.81-0.88) and in Medicare Advantage plans (OR 0.82; 95% CL 0.81-0.83). Female gender was also associated with a lower likelihood of receiving a statin and/or ezetimibe prescription from a cardiologist for patients in commercial plans (OR 0.69; 95% CL 0.65-0.74) and in Medicare Advantage plans (OR 0.78; 95% CL 0.76-0.79). CONCLUSIONS: Compared with men, women were less likely to visit a cardiologist and less likely to receive a prescription for a statin and/or ezetimibe from a cardiologist. FUNDING: Amgen Inc.

Adherence to Statin Therapy Among US Adults Between 2007 and 2014.

Background Prior studies suggest that persistence with and adherence to statin therapy is low. Interventions to improve statin persistence and adherence have been developed over the past decade. Methods and Results This was a retrospective cohort study of adults aged ≥21 y with commercial or government health insurance in the MarketScan (Truven Health Analytics) and Medicare databases who initiated statins in 2007-2014 and (1) started treatment after a myocardial infarction (n=201 573), (2) had diabetes mellitus but without coronary heart disease (CHD; n=610 049), or (3) did not have CHD or diabetes mellitus (n=2 244 868). Persistence with (ie, not discontinuing treatment) and high adherence to statin therapy were assessed using pharmacy fills in the year following treatment initiation. In 2007 and 2014, the proportions of patients persistent with statin therapy were 78.1% and 79.1%, respectively, among those initiating treatment following myocardial infarction; 66.5% and 67.3%, respectively, for those with diabetes mellitus but without CHD; and 64.3% and 63.9%, respectively, for those without CHD or diabetes mellitus. Between 2007 and 2014, high adherence to statin therapy increased from 57.9% to 63.8% among patients initiating treatment following myocardial infarction and from 34.9% to 37.6% among those with diabetes mellitus but without CHD (each Ptrend<0.001). Among patients without CHD or diabetes mellitus, high adherence did not improve between 2007 (35.7%) and 2014 (36.8%; Ptrend=0.14). In 2014, statin adherence was lower among younger, black, and Hispanic patients versus white patients and those initiating a high-intensity statin dosage. Statin adherence was higher among men and patients with cardiologist care following treatment initiation. Conclusions Persistence with and adherence to statin therapy remain low, particularly among those without CHD.

Left ventricular noncompaction cardiomyopathy: updated review.

The first case of noncompaction was described in 1932 after an autopsy performed on a newborn infant with aortic atresia/coronary-ventricular fistula. Isolated noncompaction cardiomyopathy was first described in 1984. A review on selected/relevant medical literature was conducted using Pubmed from 1984 to 2013 and the pathogenesis, clinical features, and management are discussed. Left ventricular noncompaction (LVNC) is a relatively rare congenital condition that results from arrest of the normal compaction process of the myocardium during fetal development. LVNC shows variability in its genetic pattern, pathophysiologic findings, and clinical presentations. The genetic heterogeneity, phenotypical overlap, and variety in clinical presentation raised the suspicion that LVNC might just be a morphological variant of other cardiomyopathies, but the American Heart Association classifies LVNC as a primary genetic cardiomyopathy. The familiar type is common and follows a X-linked, autosomal-dominant, or mitochondrial-inheritance pattern (in children). LVNC can occur in isolation or coexist with other cardiac and/or systemic anomalies. The clinical presentations are variable ranging from asymptomatic patients to patients who develop ventricular arrhythmias, thromboembolism, heart failure, and sudden cardiac death. Increased awareness over the last 25 years and improvements in technology have increased the identification of this illness and improved the clinical outcome and prognosis. LVNC is commonly diagnosed by echocardiography. Other useful diagnostic techniques for LVNC include cardiac magnetic resonance imaging, computerized tomography, and left ventriculography. Management is symptom based and patients with symptoms have a poorer prognosis. LVNC is a genetically heterogeneous disorder which can be associated with other anomalies. Making the correct diagnosis is important because of the possible associations and the need for long-term management and screening of living relatives.

The effects of spirituality and religion on outcomes in patients with chronic heart failure.

Heart failure (HF) is a chronic progressive disease with marked morbidity and mortality. Patients enduring this condition suffer from fluctuations in symptom burden such as fatigue, shortness of breath, chest pain, sexual dysfunction, dramatic changes in body image and depression. As physicians, we often ask patients to trust in our ability to ameliorate their symptoms, but oftentimes we do not hold all of the answers, and our best efforts are only modestly effective. The suffering endured by these individuals and their families may even call into question one's faith in a higher power and portends to significant spiritual struggle. In the face of incurable and chronic physical conditions, it seems logical that patients would seek alternative or ancillary methods, notably spiritual ones, to improve their ability to deal with their condition. Although difficult to study, spirituality has been evaluated and deemed to have a beneficial effect on multiple measures including global quality of life, depression and medical compliance in the treatment of patients with HF. The model of HF treatment incorporates a multidisciplinary approach. This should involve coordination between primary care, cardiology, palliative care, nursing, patients and, importantly, individuals providing psychosocial as well as spiritual support. This review intends to outline the current understanding and necessity of spirituality's influence on those suffering from HF.

Case of fulminant giant-cell myocarditis associated with polymyositis, treated with a biventricular assist device and subsequent heart transplantation.

Giant-cell myocarditis is an autoimmune myocarditis that rapidly progresses to heart failure, and is often associated ventricular tachycardia. We describe an otherwise healthy patient who was acutely ill with decompensated heart failure and ventricular tachycardia associated with rash and polymyositis, who then developed cardiogenic shock and multiorgan failure due to giant-cell myocarditis.

Maximal care considerations when treating patients with end-stage heart failure: ethical and procedural quandaries in management of the very sick.

Deciding who should receive maximal technological treatment options and who should not represents an ethical, moral, psychological and medico-legal challenge for health care providers. Especially in patients with chronic heart failure, the ethical and medico-legal issues associated with providing maximal possible care or withholding the same are coming to the forefront. Procedures, such as cardiac transplantation, have strict criteria for adequate candidacy. These criteria for subsequent listing are based on clinical outcome data but also reflect the reality of organ shortage. Lack of compliance and non-adherence to lifestyle changes represent relative contraindications to heart transplant candidacy. Mechanical circulatory support therapy using ventricular assist devices is becoming a more prominent therapeutic option for patients with end-stage heart failure who are not candidates for transplantation, which also requires strict criteria to enable beneficial outcome for the patient. Physicians need to critically reflect that in many cases, the patient's best interest might not always mean pursuing maximal technological options available. This article reflects on the multitude of critical issues that health care providers have to face while caring for patients with end-stage heart failure.

Testosterone therapy: treatment of metabolic disturbances in heart failure.

Heart failure (HF) is a complex progressive multisystem disease state with significant morbidity and mortality, which is not solely defined by pathology of the cardiovascular system but also is influenced by neurohormonal regulatory adjustments, peripheral cytokines, as well as hormonal and musculoskeletal dysfunction. Recent attention to the catabolic state found in patients with chronic heart failure has sparked interest in new potential targets for medical therapy. In particular, as many as 26% to 37% of men affected with HF have been found to be testosterone deficient. The severity of androgen deficiency has been shown to correlate with symptoms, functional class, and prognosis in patients with heart failure. Testosterone supplementation has been an accepted therapy in hypogonadal men with fatigue, muscle wasting, and sexual dysfunction for some time. Patients with severe HF show a similar constellation of symptoms and hypothetically would benefit from androgen replacement. Recent clinical studies have confirmed that functional, biochemical, and cardiopulmonary status in patients with HF have significant improvements when treated with testosterone supplementation. Symptomatic improvements may be obtainable in hypogonadal patients with HF who receive supplemental testosterone. This review seeks to outline the cardiovascular and peripheral effects of testosterone supplementation in patients with chronic HF.

Clinical applications of bivalirudin in the cardiac catheterization laboratory.

Heparin has been used in the catheterization laboratory to prevent ischemic complications of percutaneous coronary intervention (PCI). Bivalirudin, a direct thrombin inhibitor, is an anticoagulant that has several pharmacologic advantages over heparin, and it has been proposed that bivalirudin is superior to heparin in its ability to prevent bleeding complications of PCI. As such, there have been a variety of large prospective clinical trials comparing bivalirudin and heparin over the past 13 years. The results of these trials have prompted the general acceptance of bivalirudin as a safe alternative to heparin use during PCI, and bivalirudin has been given a class 1 recommendation by the American College of Cardiology/American Heart Association (ACC/AHA) guidelines for a variety of clinical indications. This article will review the data supporting the use of bivalirudin in the cardiac catheterization laboratory and describe several advantages of bivalirudin over traditional heparin use. We also include a discussion of the use of bivalirudin in conjunction with other medications that are frequently used in the catheterization laboratory. We end with an analysis of the economic differences between bivalirudin and heparin and the impact that financial factors may have on the choice of anticoagulant.

Heart failure therapy: beyond the guidelines.

Heart failure is a chronic and debilitating disease responsible for high cardiac morbidity and mortality in the world and is associated with over 290 000 deaths in the United States each year. This article reviews palliative care and self-care, which are critical components of heart failure management that are inadequately defined in the current American College of Cardiology/American Heart Association Guidelines for the Diagnosis and Management of Heart Failure. Palliative care describes a multidisciplinary approach to the treatment of heart failure therapy that addresses both the symptomatic and psychosocial aspects of the disease. Self-care aims to maintain disease stability and prevent clinical decline through a variety of patient-based behavioral and lifestyle modifications.

The new concept of ''interventional heart failure therapy'': part 2--inotropes, valvular disease, pumps, and transplantation.

Recent advances in heart failure therapy include a variety of mechanical and device-based technologies that target structural aspects of heart failure that cannot be treated with drug therapy alone; these newer therapies can collectively be described as interventional heart failure therapy. This article is the second in a 2-part series reviewing interventional heart failure therapy. Interventions included in this discussion include those indicated for the treatment of end-stage refractory heart failure, including interventional medical therapy, interventional treatment of valvular disease, mechanical assist devices, and heart transplantation. Also included is a review of the currently available catheter-based pumps, which are intended to provide temporary support in patients with acute hemodynamic compromise. The use of cellular or stem cell therapy for the treatment of heart failure is an emerging interventional therapy and data supporting its use for the treatment heart failure will also be presented, as will a discussion of the role of palliative care and self-care in heart failure therapy.

The emergence of oral tadalafil as a once-daily treatment for pulmonary arterial hypertension.

Pulmonary hypertension (PH) is found in a vast array of diseases, with a minority representing pulmonary arterial hypertension (PAH). Idiopathic PAH or PAH in association with other disorders has been associated with poor survival, poor exercise tolerance, progressive symptoms of dyspnea, and decreased quality of life. Left untreated, patients with PAH typically have a progressive decline in function with high morbidity ultimately leading to death. Advances in medical therapy for PAH over the past decade have made significant inroads into improved function, quality of life, and even survival in this patient population. Three classes of pulmonary artery-specific vasodilators are currently available in the United States. They include prostanoids, endothelin receptor antagonists, and phosphodiesterase type 5 (PDE5) inhibitors. In May 2009, the FDA approved tadalafil, the first once-daily PDE5 inhibitor for PAH. This review will outline the currently available data on tadalafil and its effects in patients with PAH.

Review article: the new concept of interventional heart failure therapy--part 1: electrical therapy, treatment of CAD, fluid removal, and ventricular support.

Congestive heart failure is a chronic and debilitating disease responsible for high cardiac morbidity and mortality in the world and is associated with more than 290 000 deaths in the United States each year. Recent advances in heart failure therapy target many of the mechanical and structural aspects of heart failure that are not addressed by drug-based therapies; these include abnormalities in electrical conduction, coronary artery or valvular architecture, and in ventricular size and shape. To target these abnormalities, newer therapies have largely been mechanical and device-based in nature and can be collectively described as interventional therapy. Interventional therapy includes the use of interventional medical therapy, electrical-based devices to augment ventricular function, catheterization-based devices for the treatment of underlying coronary artery disease and valvular disease, machines for the removal of excess fluid, mechanical pumps to assist the ventricles, surgical techniques aimed at reshaping the ventricles, the use of tissue therapies such as stem cell transplantation or complete heart transplant, palliative care, and self-care. This article is the first in a 2-part series that will review interventional heart failure therapy and present the most recent data supporting its use.

Persistent sexual dysfunction impairs quality of life after cardiac transplantation.

INTRODUCTION: The impact of sexual dysfunction (SD) on mental and physical health after heart transplantation (HTx) has not been established. AIM: We investigated the relationship of SD on quality of life (QoL), physical and mental health, and depressive symptoms after HTx. MAIN OUTCOME MEASURES: We evaluated SD according to the International Index of Erectile Dysfunction and the Female Sexual Function Index. QoL, physical and mental health were assessed using: 1) Short Form 12 Health Survey Questionnaire, 2) Quality of Life Enjoyment and Satisfaction Questionnaire--Short Form, and two depressive symptoms questionnaires: 1) Beck Depression Inventory-II and 2) Quick Inventory Depressive Symptomatology-Self Report. METHODS: We enrolled patients who were greater than 6 months post HTx. Patients unable to read English, had pelvic surgery or trauma, urogenital abnormalities, or sexually inactive were excluded. RESULTS: Out of 79 subjects that were screened, 33 men and 6 women participated (mean age 61.4 + 1.4). Response rates were at least 82% for all questionnaires. Overall prevalence of SD was 61%, with 78% of men being affected and 50% of women. There was no significant difference in measures between genders. HTx recipients with SD reported significantly worse QoL on measures of physical health when compared to those without SD. After HTx, patients suffering from SD had significantly worse general health (P = 0.02) and physical health (P = 0.02), including physical functioning (P = 0.01) and physical role limitation (P = 0.01). In contrast, mental health and depressive symptoms after HTx were not significantly different between those with and without SD. CONCLUSIONS: After HTx a high prevalence of SD remains among both men and women. Patients with SD had worse general and physical health but not depressive symptoms when compared to those without SD. The contributing factors may be more related to physical rather than psychological causes.

Growth hormone and testosterone in heart failure therapy.

IMPORTANCE OF THE FIELD: Heart failure is a progressive disease affecting millions of people worldwide. The disease carries a significantly high morbidity and mortality risk. There are multiple pharmaceutical options to decrease this risk and prolong survival; however, despite optimization of medical management, several patients still await heart transplant, the only definitive cure for heart failure. To slow the progression of disease preventing need for transplantation, improve clinical symptoms, and improve heart failure outcomes, there is a persistent need to discover new therapeutic strategies. Of interest, low growth hormone and testosterone levels have been associated with a worsening degree of heart failure. Many studies have begun to show a clinical improvement in heart failure symptoms when these levels are corrected with hormonal therapy. These findings, although mixed, are promising and indicate that both testosterone and growth hormone therapy should be considered as adjunctive therapy in advanced heart failure patients. AREAS COVERED IN THIS REVIEW: This review discusses the physiology of both of these natural hormones, their therapeutic effects in heart failure and data from the published literature on studies using growth hormone or testosterone in patients with chronic heart failure. An extensive search of PubMed was conducted for topics on heart failure, growth hormone, insulin-like growth factor, testosterone, their physiology and pathophysiology, and trials in which they have been used as therapeutic interventions between 1989 and 2009. WHAT THE READER WILL GAIN: The reader will gain an understanding of the intricate balance of both of these hormones in the disease state of heart failure. In addition, the trials conducted using these hormones in pharmacotherapy for heart failure are discussed along with proposed theories for interstudy variability. TAKE HOME MESSAGE: Testosterone deficiency and growth hormone resistance are positively associated with a poor state of heart failure. Treatment of deficiency improves outcomes in heart failure; however, there is a significant paucity of data with regard to testosterone and heart failure as well as a significant amount of study variability with growth hormone and heart failure.

Plasma myeloperoxidase levels in patients with chronic heart failure.

Increased oxidative stress and endothelial dysfunction are commonly observed in patients with chronic heart failure (HF). The relation between myeloperoxidase (MPO), an inflammatory marker with mechanistic links to plaque vulnerability and abnormal ventricular remodeling, and degrees of severity in chronic HF has not been reported. Plasma MPO levels were measured in 105 normal controls (no history of HF or left ventricular dysfunction) and 102 patients with chronic systolic HF (left ventricular ejection fraction <50%), and the relations among plasma MPO levels, plasma B-type natriuretic peptide levels, and the left ventricular ejection fraction were examined. Plasma MPO levels in patients with chronic systolic HF were significantly elevated compared with those of healthy controls (1,158 +/- 2,965 vs 204 +/- 139 pM, p <0.0001). Plasma MPO levels increased in parallel with increasing New York Heart Association class (p <0.0001) and were correlated with plasma B-type natriuretic peptide levels (Spearman's r = 0.39, p <0.0001). Levels of MPO were strongly associated with the prevalence of HF (unadjusted odds ratio 30.3, 95% confidence interval 11.1 to 94.5) and remained significant when adjusted for age and B-type natriuretic peptide (odds ratio 27.7, 95% confidence interval 3.6 to 371.1). In conclusion, in a cohort of patients with chronic HF, plasma MPO levels were elevated compared with those of normal controls and were associated with worsening functional class.

Comparative sensitivities between different plasma B-type natriuretic peptide assays in patients with minimally symptomatic heart failure.

Plasma B-type natriuretic peptide (BNP) assays have become widely used to diagnose and manage patients with heart failure. However, differences in assay characteristics may have important implications when BNP is used as a screening test for heart failure at a specific cutoff value. We performed a prospective comparison of 2 commercially available assays--one that is a laboratory-based, microparticle enzyme immunoassay (MEIA) that uses EDTA plasma specimens and one that is a point-of-care (POC), single-use fluorescence immunoassay that uses EDTA--anticoagulated whole blood or plasma specimens-in patients with heart failure and healthy controls. Despite the overall concordance between different SNP assays for the diagnosis of heart failure, their sensitivities may differ when compared at the approved diagnostic cutoff value of 100 pg/mL. At this cutoff value, the MEIA on AxSYM demonstrated greater sensitivity than POC Triage BNP assay in minimally symptomatic patients with heart failure. Therefore, for screening purposes, cutoff values for plasma BNP or N-terminal pro-BNP levels should be specific for each assay to optimize test performance. These findings suggest that there is a relationship between the decision statistics used in screening for left ventricular dysfunction and the type of diagnostic assay used.