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Studies have shown poor correlation between intra-cardiac pressures and blood volume (BV) measurements including HF. The impact of sex and left ventricular ejection fraction (LVEF) on this relationship has not been studied. We obtained pressure (pulmonary artery diastolic pressure (PADP)) and volume (total blood volume (TBV) and estimated stress blood volume (eSBV)) measurements from HF patients at the time of CardioMEMS implantation. A total of 20 patients were included. There was no significant difference between PADP, TBV, and eSBV between sexes. There was only a moderate correlation between PADP and eSBV in men but not in women or with TBV in both sexes. HFrEF had higher PADP and eSBV than HFpEF. There was a consistent lack of correlation between PADP and both TBV and eSBV. Further studies evaluating mid- to long-term implications of pressure-volume profiles as well as changes following decongestion therapy are warranted to better understand the pressure-volume interplay and determine appropriate decongestion strategy for each pressure-volume phenotype.

To review and analyze the clinical outcomes of thermal therapy (≤1.4°C increase in core body temperature) in patients with heart failure (HF). A systematic review and meta-analysis regarding the effects of thermal therapy on HF was done by searching PubMed, Ovid Medline, Ovid Embase, Scopus, and internal databases up to date (2019). Improvement in the New York Heart Association (NYHA) class: Ten studies with 310 patients showed significant improvement in NYHA class. Only 7 among 40 patients remained in Class IV and 99 patients in Class III from 155 patients. Increased patients in lower classes indicate that more patients showed improvement. Sixteen studies on 506 patients showed an overall improvement of 4.4% of left ventricular ejection fraction (LVEF). Four studies reported improved endothelial dysfunction by 1.7% increase in flow-mediated dilation (FMD) on 130 patients. Reduction in blood pressure: Thermal therapy reduced both systolic blood pressure (SBP) and diastolic blood pressure by 3.1% and 5.31%, respectively, in 431 patients of 15 studies. Decrease in cardiothoracic ratio (CTR): Eight studies reported an average of 5.55% reduction of CTR in a total of 347 patients. Improvement in oxidative stress markers: Plasma brain natriuretic peptide (BNP) levels significantly decreased (mean difference of 14.8 pg/dL) in 303 patients of 9 studies. Improvement of quality of life: Among 65 patients, thermal therapy reduced cardiac death and rehospitalization by 31.3%. A slight increase in core body temperature is a promising, noninvasive, effective, and complementary therapy for patients with HF. Further clinical studies are recommended.

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Supplemental Digital Content is available in the text., Background: In the WRAP-IT trial (Worldwide Randomized Antibiotic Envelope Infection Prevention), adjunctive use of an absorbable antibacterial envelope resulted in a 40% reduction of major cardiac implantable electronic device infection without increased risk of complication in 6983 patients undergoing cardiac implantable electronic device revision, replacement, upgrade, or initial cardiac resynchronization therapy defibrillator implant. There is limited information on the cost-effectiveness of this strategy. As a prespecified objective, we evaluated antibacterial envelope cost-effectiveness compared with standard-of-care infection prevention strategies in the US healthcare system. Methods: A decision tree model was used to compare costs and outcomes of antibacterial envelope (TYRX) use adjunctive to standard-of-care infection prevention versus standard-of-care alone over a lifelong time horizon. The analysis was performed from an integrated payer-provider network perspective. Infection rates, antibacterial envelope effectiveness, infection treatment costs and patterns, infection-related mortality, and utility estimates were obtained from the WRAP-IT trial. Life expectancy and long-term costs associated with device replacement, follow-up, and healthcare utilization were sourced from the literature. Costs and quality-adjusted life years were discounted at 3%. An upper willingness-to-pay threshold of $150 000 per quality-adjusted life year was used to determine cost-effectiveness, in alignment with the American College of Cardiology/American Heart Association practice guidelines and as supported by the World Health Organization and contemporary literature. Results: The base case incremental cost-effectiveness ratio of the antibacterial envelope compared with standard-of-care was $112 603/quality-adjusted life year. The incremental cost-effectiveness ratio remained lower than the willingness-to-pay threshold in 74% of iterations in the probabilistic sensitivity analysis and was most sensitive to the following model inputs: infection-related mortality, life expectancy, and infection cost. Conclusions: The absorbable antibacterial envelope was associated with a cost-effectiveness ratio below contemporary benchmarks in the WRAP-IT patient population, suggesting that the envelope provides value for the US healthcare system by reducing the incidence of cardiac implantable electronic device infection. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02277990.

Antitachycardia pacing (ATP) is routinely used to terminate ventricular tachyarrhythmias (VTs). However, little guidance exists on the most effective programming of ATP.This study evaluated whether additional ATP sequences are more effective in reducing implantable cardioverter-defibrillator shocks.In patients from the Shock-Less study, the number of overall shocks were compared between patients programmed to ≤3 ATP sequences (VT zone) and ≤1 ATP sequence (fast ventricular tachycardia [FVT] zone) (nominal group) and patients programmed to receive additional ATP sequences in VT (3) or FVT (1) zones.Of the 4112 patients (15% receiving secondary prevention; 77% men; mean age 65.9 ± 12.6 years), 1532 patients (37%) were programmed with additional ATP sequences (1025 with3 ATP sequences in the VT zone; 699 patients with1 ATP sequence in the FVT zone). Over a mean follow-up period of 19.6 ± 10.7 months, 4359 VT/FVT episodes occurred in 591 patients. Compared with the nominal group, in patients with additional ATP programming, there was a 39% reduction in the number of shocked VT episodes (0.46 episodes per patient-year vs 0.28 episodes per patient-year; incidence rate ratio [IRR] 0.61; P.001) and a 44% reduction in the number of shocked FVT episodes (0.83 episodes per patient-year vs 0.47 episodes per patient-year; IRR 0.56; P.001). The reduction in shocked VT episodes was observed in both primary (IRR 0.68; 95% confidence interval 0.51-0.90; P = .007) and secondary (IRR 0.51; 95% confidence interval 0.35-0.72; P.001) prevention patients.Programming more than the nominal number of ATP sequences in both the VT and FVT zones is associated with a lower occurrence of implantable cardioverter-defibrillator shocks in clinical practice.

The analysis of capitalist relations that Marx articulated in 1867 remains relevant today in the early decades of the twenty-first century. Using a methodology defined by abstraction, dialectics, and a historicist approach, he was able to highlight the inherent tendencies and internal contradictions of capitalism as a system of production, distribution, and consumption that underlies the modern social, cultural, and political fabric of social life. The necessity of confronting today the crises that have arisen from a now global capitalist political economy means that Marx’s insights are no less important today than they were when he was writing. At the same time, changes that have occurred within the capitalist system over the course of the past 150 years have prompted a rethinking of some basic elements of Marx’s original formulations. Each of the contributions to this volume point to the continued relevance of the insights Marx offered in the three volumes of Capital.

Background Transthyretin amyloidosis (ATTR) is a heterogeneous disorder with multiorgan involvement and a genetic or nongenetic basis. Objectives The goal of this study was to describe ATTR in the United States by using data from the THAOS (Transthyretin Amyloidosis Outcomes Survey) registry. Methods Demographic, clinical, and genetic features of patients enrolled in the THAOS registry in the United States (n = 390) were compared with data from patients from other regions of the world (ROW) (n = 2,140). The focus was on the phenotypic expression and survival in the majority of U.S. subjects with valine-to-isoleucine substitution at position 122 (Val122Ile) (n = 91) and wild-type ATTR (n = 189). Results U.S. subjects are older (70 vs. 46 years), more often male (85.4% vs. 50.6%), and more often of African descent (25.4% vs. 0.5%) than the ROW. A significantly higher percentage of U.S. patients with ATTR amyloid seen at cardiology sites had wild-type disease than the ROW (50.5% vs. 26.2%). In the United States, 34 different mutations (n = 201) have been reported, with the most common being Val122Ile (n = 91; 45.3%) and Thr60Ala (n = 41; 20.4%). Overall, 91 (85%) of 107 patients with Val122Ile were from the United States, where Val122Ile subjects were younger and more often female and black than patients with wild-type disease, and had similar cardiac phenotype but a greater burden of neurologic symptoms (pain, numbness, tingling, and walking disability) and worse quality of life. Advancing age and lower mean arterial pressure, but not the presence of a transthyretin mutation, were independently associated with higher mortality from a multivariate analysis of survival. Conclusions In the THAOS registry, ATTR in the United States is overwhelmingly a disorder of older adult male subjects with a cardiac-predominant phenotype. Val122Ile is the most common transthyretin mutation, and neurologic phenotypic expression differs between wild-type disease and Val122Ile, but survival from enrollment in THAOS does not. (Transthyretin-Associated Amyloidoses Outcome Survey [THAOS]; NCT00628745)

Heart failure (HF) affects millions of Americans and causes financial burdens because of the need for rehospitalization. For this reason, health care systems and patients alike are seeking methods to decrease readmissions. We assessed the potential for reducing readmissions of patients with postacute care HF through an educational program combined with enhanced external counterpulsation (EECP). We examined 99 patients with HF who were referred to EECP centers and received heart failure education and EECP treatment within 90 days of hospital discharge from March 2013 to January 2015. We compared observed and predicted 90-day readmission rates and examined results of 6-minute walk tests, Duke Activity Status Index, New York Heart Association classification, and Canadian Cardiovascular Society classification before and after EECP. Patients were treated with EECP at a median augmentation pressure of 280 mm Hg (quartile 1 = 240, quartile 3 = 280), achieved as early as the first treatment. Augmentation ratios varied from 0.4 to 1.9, with a median of 1.0 (quartile 1 = 0.8, quartile 3 = 1.2). Only 6 patients (6.1%) had unplanned readmissions compared to the predicted 34%, p

Background Total Blood Volume (TBV) overload frequently causes shortness of breath and fatigue in heart failure (HF)-related hospital admissions. Red cell volume (RBCV) variations in the same population, unrecognized and largely untreated without quantitative blood volume analysis, suggest an independent causal role in symptom production, short, and long-term outcomes. RBCV phenotypes, their prevalence, distribution, and impact on length of stay (LOS) were studied in a previously published series of hospitalized heart failure patients. Methods In a series of 245 consecutive HF admissions to a community hospital (Sept 2007-Apr 2014, age 78±10 yrs., HFrEF 46%, Stage 4 CKD 30%), Total blood volume (TBV) and Red Cell Volume (RBCV) were measured at admission by blood volume analysis (BVA), an I-131 labeled albumin indicator-dilution technique (Daxor BVA-100). True anemia was diagnosed with a RBCV deficit >10% of ideal RBCV and polycythemia was diagnosed with a RBCV excess of >10% of ideal RBCV. True anemia was corrected with IV iron, epoetin, and/or packed red blood cells when appropriate. Results Only 37% of these patients were hypervolemic (TBV >10% excess), but 62% had true anemia (> 10% deficit from ideal RBCV); true anemia was equally distributed across ejection fraction (EF) ranges, 50.3% of patients with reduced EF ( 10% excess from ideal TBV) (12%), and Polycythemia (> 10% excess from ideal RBCV) with Hypervolemia (10%). Peripheral hematocrit measured at the time of blood volume analysis was unable to distinguish between RBCV phenotypes. True Anemia was present in 44/60 patients whose hospital length of stay (LOS) exceeded 10 days compared to 16/60 patients without anemia and a > 10 day LOS (p Conclusion True anemia was a surprisingly consistent feature in 62% of the HHF patients. Only 27% of patients in the series presented with a normal RBCV. Peripheral hematocrit could not be used to identify RBCV phenotypes. True anemia was present in nearly three times as many patients with LOS > 10 days, indicating it is a marker of disease severity that must be recognized and treated early in the hospital course. Treatment should be guided by the specific RBCV phenotype and the laboratory evaluation of the anemia or polycythemia. Further controlled evaluation of the impact of RBCV phenotype on short- and long-term outcomes in HHF patients following volume-guided treatment is necessary.

Hyperkalemia is defined as serum potassium concentrations elevated above the upper limit of normal (> 5.0 mEq/L). It has become more common in cardiovascular practice due to the growing population of patients with chronic kidney disease and the broad application of drugs that modulate renal elimination of potassium by reducing production of angiotensin II (angiotensin-converting enzyme inhibitors, direct renin inhibitors, β-adrenergic receptor antagonists), blocking angiotensin II receptors (angiotensin receptor blockers), or antagonizing the action of aldosterone on mineralocorticoid receptors (mineralocorticoid receptor antagonists). The risk of hyperkalemia is a major limiting factor for the use of these disease-modifying drugs in both acute and chronic cardiorenal syndromes. Thus, agents to control the plasma concentration of potassium are needed in the multidrug treatment of cardiorenal disease, including chronic kidney disease, heart failure, and acute kidney injury. Novel oral therapies in development for both acute and extended use in the management of hyperkalemia include patiromer sorbitex calcium and sodium zirconium cyclosilicate. Important biochemical differences between these compounds result in unique product profiles and electrolyte outcomes in patients treated for hyperkalemia. This review highlights the major mechanisms of hyperkalemia and key results from randomized trials in a range of clinical scenarios in patients with, and at risk for, hyperkalemia.

This paper demonstrates that ‘failure’ is not a direct reflection of student knowledge. Using five years of New York State school-level data, we compare passing rates to raw-scores . We find, first, that when ‘cut scores’ are raised, more students fail even if raw scores are increasing. Second, increasing cut scores disproportionately fails more poor students than non-poor students, despite that poor students have the fastest rates of raw score improvement. Third, raised cut scores transform the smallest raw score gaps between high- and low-poverty schools into the largest passing gaps. Thus, while students in poor schools know more than they did previously, and although they have learned at superior rates, they are recast as the biggest ‘failures’ they have ever been.

Implantable cardioverter-defibrillator (ICD) shocks are associated with increased anxiety, health care utilization, and potentially mortality.The purpose of the Shock-Less Study was to determine if providing feedback reports to physicians on their adherence to evidence-based shock reduction programming could improve their programming behavior and reduce shocks.Shock-Less enrolled primary prevention (PP) and secondary prevention (SP) ICD patients between 2009 and 2012 at 118 study centers worldwide and followed patients longitudinally after their ICD implant. Center-specific therapy programming reports (TPRs) were delivered to each center 9 to 12 months after their first enrollment. The reports detailed adherence to evidence-based programming targets: number of intervals to detect ventricular fibrillation (VF NID), longest treatment interval (LTI), supraventricular tachycardia (SVT) discriminators (Wavelet, PR Logic), SVT limit, Lead Integrity Alert (LIA), and antitachycardia pacing (ATP). Clinicians programmed ICDs at their discretion. The primary outcome measure was the change in utilization of evidence-based shock reduction programming before (phase I, n = 2694 patients) and after initiation of the TPR (phase II, n = 1438 patients).Patients implanted after feedback reports (phase II) were up to 20% more likely to have their ICDs programmed in line with evidence-based shock reduction programming (eg, VF NID in PP patients 30/40 in 33.5% vs 18.6%, P.0001). Patients implanted in phase II had a lower risk of all-cause shock (adjusted hazard ratio 0.72, 95% confidence interval 0.58-0.90, P = .003).Providing programming feedback reports improves adherence to evidence-based shock reduction programming and is associated with lower risk of ICD shocks.

Few proven treatment options exist for patients with heart failure with preserved ejection fraction (HFpEF). One of the few interventions shown to improve functional capacity in patients with HFpEF is exercise training, likely predominantly driven by peripheral mechanisms such as improved

Concentrations of both B-type natriuretic peptide (BNP) and amino-terminal pro-BNP (NT-proBNP) are useful for diagnostic evaluation of patients with acute decompensated heart failure (ADHF), providing important information regarding presence and severity of heart failure. In addition, levels of both BNP and NT-proBNP are strongly prognostic for adverse outcomes in this setting. While values for BNP and NT-proBNP at hospital admission predict impending risk for adverse outcome, their measurement following HF treatment provides incremental prognostic information, even more accurately identifying patients at highest risk for death or rehospitalization in the short term. Thus, changes in BNP or NT-proBNP following treatment should be considered an important part of the pre-discharge decision making for patients hospitalized with ADHF.

This article elaborates a distinction between public school's obligation to provide high quality learning versus its capacity to meet that obligation. A school's capacity can be assessed by two concepts: obstacles to learning and community affluence. Obstacles inhibit academic performance, and include concentrated poverty, racial/ethnic segregation, and high rates of English-language learners. Affluence is the economic vitality of a school's larger environment, reflecting resources such as tax base, property value, and aggregate wealth. Analyses of 659 public schools from suburban New York's Nassau and Suffolk counties (Long Island) confirm that increasing obstacles lowers school-level outcomes, while increasing affluence improves them. We show that obstacles and affluence are inversely related: schools with the highest obstacles have the fewest resources, and schools awash with resources face minimal obstacles. These trends hold in the middle ranges as well. Further, the effect of affluence on academic p...

The objective was to evaluate 6 commonly used heart failure (HF) prognostic models in an elderly, fatal HF population. Predictive models have been established to quantify risk among HF patients. The validation of these models has not been adequately studied, especially in an elderly cohort. Applying a single-center, retrospective study of serially admitted HF patients who died while in the hospital or within 30 days of discharge, the authors evaluated 6 prognostic models: the Seattle Heart Failure Model (SHFM), Heywood's model, Classification and Regression Tree (CART) Analysis, the Heart Failure Survival Score (HFSS), Heart Failure Risk Scoring System, and Pocock's score. Eighty patients were included (mean age, 82.7 ± 8.2 years). Twenty-three patients (28.75%) died in the hospital. The remainder died within 30 days of discharge. The models' predictions varied considerably from one another and underestimated the patients' actual mortality. This study demonstrates that these models underestimate the mortality risk in an elderly cohort at or approaching the end of life. Moreover, the predictions made by each model vary greatly from one another. Many of the models used were not intended for calculation during hospitalization. Development of improved models for the range of patients with HF syndromes is needed.

Depression is prevalent in patients with heart failure, and the two conditions share underlying physiologic mechanisms. The prevalence of depression increases sharply with the severity of heart failure symptoms, an important consideration when confronting patients with worsening heart failure. Depression leads to poorer outcomes in patients with heart failure, including increased risk of poor functional status, hospital readmission, and death. Although beta-blockers are often implicated in the development and exacerbation of depression, evidence for this association is lacking, so withholding beta-blocker therapy is not recommended for patients with heart failure and depression. Evidence on whether therapy for depression also improves cardiac outcomes in heart failure patients is inconclusive, and further research on this question is needed. Nevertheless, early identification of depression in heart failure patients is imperative, as it can facilitate intervention attempts.

Purpose of review Anemia is a relatively common finding in heart failure. Anemia in heart failure patients has been independently associated with reduced exercise tolerance, increased heart failure hospitalizations and increased all-cause mortality. Anemia would appear to be a reasonable treatment target for patients with heart failure. The review will discuss the potential causes of anemia in heart failure patients and give an up-to-date overview of treatment trials. Recent findings Studies assessing the pathophysiology of anemia in heart failure patients have recently demonstrated the potential importance of iron deficiency, abnormal iron metabolism and hemodilution. Treatment studies have focused on the use of erythropoiesis-stimulating agents, with recent trials showing mixed results. Summary Despite initial studies indicating a possible beneficial effect of erythropoiesis-stimulating agents in the treatment of anemic heart failure patients, clinical trial data, to date, have failed to show convincing evidence for morbidity or mortality benefit, and information on the long-term safety is lacking. Ongoing large-scale trials will have the potential to provide such information in the future.

Background— More than 400 patients with end-stage heart failure underwent left ventricular assist device (LVAD) implantation of LVAD as destination therapy (DT) after the US Food and Drug Administration approval of DT in 2002. Because most of these patients had surgeries at hospitals that were newly accredited, we sought to examine the impact of LVAD center volume on the outcomes of DT. Methods and Results— From July 1998 through December 2005, a total of 377 patients underwent implantation of HeartMate I LVAD as DT at 68 centers in the United States. Using data from the Thoratec DT Registry, we examined the association between LVAD center volume at the time of surgery and 1-year survival with DT. Of the studied 377 DT recipients, 53% underwent device implantation at centers that performed ≤4 DT implants at the time of surgery. Center experience with DT seemed to significantly correlate with the 1-year survival (47.8% versus 67.4% in recipients of ≤4th DT versus >9th DT implant; P =0.009). However, the DT center volume was not an independent predictor of 1-year survival with DT when adjusted for the preoperative DT Risk Score, suggesting that other factors, such as improved candidate selection, may have accounted for the institutional learning curve. Conclusions— The institutional experience with DT may have a significant impact on outcomes of this therapy. Better selection of candidates, systemic approach to surgical and postoperative care, as well as the long-term medical management most likely all contribute to these improvements.

Background— Prior investigations suggest that superimposing continuous flow on aortic flow (continuous aortic flow augmentation) produces vasodilation, cardiac unloading, and improved cardiac performance. Methods and Results— We compared percutaneous continuous aortic flow augmentation (flow ≤1.5 L/min for up to 96 hours) plus medical therapy versus medical therapy alone by randomizing 168 patients (device, n=109; control, n=59) hospitalized with heart failure, reduced left ventricular ejection fraction and cardiac index, elevated pulmonary capillary wedge pressure, and renal impairment or substantial diuretic requirement despite intravenous inotropes/vasodilators. The primary composite efficacy end point included pulmonary capillary wedge pressure (72 to 96 hours) and days alive out of hospital off mechanical support over 35 days. The population’s illness severity posed unique challenges. Enrollment ended early because of an inability to demonstrate significant benefit on the primary composite end point (device, 17.4%; control, 13.6%; P =0.45) in the face of excess device group bleeding. Pulmonary capillary wedge pressure decreased from 28.8±6.3 mm Hg (mean±SD) to 24.9±7.2 mm Hg (average, 72 to 96 hours) and 28.9±7.1 to 26.5±6.2 mm Hg in the device and control groups, respectively (between-group P =0.074). Cardiac index progressively increased in the device (2.05±0.53 to 2.44±0.52 L · min −1 · m −2 ) but not the control (between-group P P =0.10). Through 65 days, device-to-control hazard ratios were as follows: all-cause mortality, 1.05 (95% confidence interval, 0.60 to 1.82); death or heart failure hospitalization, 0.87 (95% confidence interval, 0.57 to 1.33); and heart failure hospitalization, 0.66 (95% confidence interval, 0.38 to 1.13). Major bleeds occurred in 16.5% in the device (7.3% treatment related) and 5.1% in the control ( P =0.05) group. Conclusions— Continuous aortic flow augmentation improved cardiac performance, improving cardiac index and pulmonary capillary wedge pressure, but statistical significance for the primary efficacy end point was not attained. Hemodynamic and clinical observations provide direction toward additional studies to further investigate the clinical effects of this treatment.

Sustained myocardial recovery and reversal of heart failure has been reported with the use of left ventricular assist devices (LVADs). However, clinical predictors of sustained recovery have not been clearly defined, and little information exists regarding exercise improvement in LVAD patients. Therefore, we sought to determine whether peripheral oxygen delivery and utilization were improved with LVAD support. Eleven patients with available pre- and post-LVAD cardiopulmonary exercise (CPX) data were studied retrospectively. Five patients received a HeartMate XVE for destination therapy (DT) and six patients received a Thoratec PVAD pneumatic LVAD for bridge-to-recovery (BTR). Oxygen uptake kinetics was assessed by fitting a single exponential function to the VO2 response. There was a significant improvement in several key parameters of cardiac performance including peak VO2, VO2 at anaerobic threshold (AT), oxygen kinetics as measured by mean response time (MRT), and oxygen deficit during LVAD support. Oxygen deficiency improved from 0.29 +/- 0.16 ml/kg to 0.16 +/- 0.06 ml/kg (p = 0.023), as did MRT 68 +/- 47.7 seconds to 35.8 +/- 13.3 seconds (p = 0.046) with LVAD support. Improved oxygen kinetics suggests improved peripheral utilization of oxygen, and may offer an additional clinical parameter to predict the likelihood of sustained recovery.

Background— Patients with American College of Cardiology/American Heart Association stage C/D heart failure experience substantial morbidity and mortality, but available interventions beyond standard medical and device therapies are limited. Nesiritide relieves dyspnea and reduces pulmonary congestion, but its risk profile is uncertain. Pilot data suggested a potential benefit of nesiritide given as serial outpatient infusions. Methods and Results— The Second Follow-Up Serial Infusions of Nesiritide (FUSION II) trial was a randomized, double-blind, placebo-controlled trial of outpatient serial nesiritide infusions for patients with American College of Cardiology/American Heart Association stage C/D heart failure. Patients with 2 recent heart failure hospitalizations, ejection fraction P =0.79). There were no statistically significant differences between groups in any of the secondary end points, including the number of cardiovascular or renal hospitalizations, the number of days alive and out of the hospital, change in Kansas City Cardiomyopathy Questionnaire score, or cardiovascular death. Adverse events were similar between groups; nesiritide was associated with more hypotension but less predefined worsening renal function. Conclusions— Serial outpatient nesiritide infusions do not provide a demonstrable clinical benefit over intensive outpatient management of patients with advanced American College of Cardiology/American Heart Association stage C/D heart failure.

Background As outcomes for destination therapy continue to improve, many patients are requiring left ventricular assist device (LVAD) exchange due to end-of-life of their LVAD. Current techniques to identify and diagnose device end-of-life issues usually require invasive testing or off-site filter dust analysis. In this study we assess a non-invasive technique using acoustic signals generated from the HeartMate XVE LVAD to potentially identify impending device end-of-life issues. Methods Nine patients were prospectively followed after implantation of the HeartMate XVE LVAD as destination therapy between May 2004 and July 2006. Acoustic signals were collected using an aquatic hydrophone system interfaced with a data acquisition system and a standard laptop computer. Data were collected at pre-set intervals. All data/acoustic signals were prospectively interpreted by a blinded independent reviewer skilled at interpreting acoustic signals. Acoustic data suggesting possible device failure were then correlated with clinical findings and LVAD examination at the time of device removal. Results All patients survived long enough to develop signs of impending device end-of-life. Four of 9 (44%) patients developed inflow valve incompetence, 4 (44%) were identified as having significant bearing wear, and 1 (12%) had both. All acoustically identified device issues were confirmed by standard clinical examinations and testing (echocardiography, angiography, laboratory tests and filter dust analysis). The acoustic findings were subsequently confirmed at time of device exchange. All patients ultimately had their device successfully exchanged and have continued to live with their new apparatus. Conclusions Acoustic signal monitoring can successfully identify HeartMate XVE device end-of-life. This new method provides a low-cost, reproducible, non-invasive technique that may be used to identify possible impending device failure.

Despite tremendous focus, effort, drug and device development and resources dedicated to the care of patients at risk for and with heart failure (HF), the epidemic continues. The HF patient presents with a widely deranged physiology and typically at the same time is malnourished adding to the disease complexity and therapeutic challenges. Most nutritional approaches for patients with HF focus on dietary restrictions (of salt and water) and lack uniformity or clarity or focus on meeting nutritional needs, barriers and deficits of the patient with HF. Finally, it seems reasonable to anticipate that any dietary program recommendation should contribute in a positive way toward HF management goals and at its foundation positively contribute to the deranged physiology. In many ways the "Dietary Approaches to Stop Hypertension" (DASH) dietary program fulfills these needs and early evidence supports the notion that the DASH diet may be optimal for patients with HF. This brief review examines some of this evidence and provides recommendations for the HF community.

Endothelial dysfunction has been recognized as a pathophysiologic mechanism in the progression of heart failure (HF). However, little attention has been given to the ability of dietary approaches to improve endothelial function. This study examined the effects of the Dietary Approaches to Stop Hypertension (DASH) diet on endothelial function, exercise capacity, and quality of life in patients with chronic symptomatic (stage C) HF. Forty-eight patients were randomized to follow the DASH diet (n = 24) or the general HF dietary recommendations (n = 24). Endothelial function was assessed by measuring large and small arterial elasticity (LAE and SAE) at rest. Exercise capacity (measured with the 6-minute walk test) and quality of life (measured with the Minnesota Living with Heart Failure Questionnaire) at baseline and 3 months were also evaluated. Patients were older adults with an average HF duration of 5 years. LAE at 1 month improved significantly in the DASH diet group (P < 0.01). Overall LAE and SAE scores at 3 months also improved; however, the net changes were not statistically significant. The DASH group had better exercise capacity (292 m vs 197 m; P = 0.018) and quality of life scores (21 vs 39; P = 0.006) over time, while sodium intake levels at 1, 2, and 3 months were comparable between the groups. Adhering to the DASH diet improved arterial compliance initially and improved exercise capacity and quality of life scores at 3 months. The DASH diet may be an important adjunctive therapy for patients with symptomatic HF.

Heart failure contributes substantially to health care costs in the United States due to its prevalence and frequent necessity for repeat hospitalizations to manage episodes of acute decompensation. Heart failure overwhelmingly impacts Medicare costs, as the highest proportion of heart failure patients are older than 65 years of age. Efforts to reduce morbidity, mortality, and health care resource utilization have been achieved successfully through emergency department-based heart failure observation units. For select patients, the observation unit can provide care with effective oral agents, including angiotensin-converting enzyme inhibitors, beta-adrenergic receptor blockers, and diuretics, as well as administration of other vasoactive agents, followed by a discharge plan of effective heart failure education and rigorous follow-up management. As advanced pharmacologic and diagnostic therapies continue to emerge, the observation unit staff can play an integral role in the critical education and self-management tools that are needed by the patient to ultimately improve outcomes and quality of life.

Balloon counterpulsation has gained widespread acceptance as a therapy for cardiogenic shock. However, over the past four decades a parallel method of noninvasive counterpulsation, enhanced external counterpulsation (EECP), has been defined and developed. Mechanisms of benefit for this technology continue to emerge and include enhanced coronary and other key target organ perfusion beds. Other mechanisms include angiogenesis and enhanced cellular metabolism. Beyond putative mechanisms there is ample evidence for improved and sustained outcomes in patients with and without left ventricular dysfunction. This evidence comes from long-term registry reports and randomized clinical trials. With respect to heart failure (HF), there is registry, pilot trial, and randomized clinical trial evidence of safety and efficacy. This paper summarizes some of the mechanisms and outcomes of EECP in HF patients and helps to elucidate the role of EECP in the management of patients with chronic HF.

Heart failure (HF) is a syndrome characterized by high mortality, frequent hospitalization, reduced quality of life, and a complex therapeutic regimen. Knowledge about HF is accumulating so rapidly that individual clinicians may be unable to readily and adequately synthesize new information into effective strategies of care for patients with this syndrome. Trial data, though valuable, often do not give direction for individual patient management. These characteristics make HF an ideal candidate for practice guidelines. The 2006 Heart Failure Society of America comprehensive practice guideline addresses the full range of evaluation, care, and management of patients with HF.

The natriuretic peptide (NP) system is primarily an endocrine system that maintains fluid and pressure homeostasis by modulating cardiac and renal function. The physiologic functions of the NP system in healthy humans and in patients with cardiovascular disease are not fully understood. NP levels are elevated in patients with heart failure (HF) and other cardiac diseases; measurement of NPs may be used in the clinical setting to aid diagnosis and prognosis. In addition, synthetic NPs such as nesiritide are available for use in management of patients with acutely decompensated congestive HF.Not only do NPs modulate volume and pressure homeostasis, but they also exert important anti-proliferative, anti-fibrotic effects in the heart. Thus, NPs may prove useful for prevention of remodeling after myocardial infarction and in advanced HF. BNP is emerging as an important biomarker in patients with HF and other cardiovascular diseases, such as pulmonary hypertension and atherosclerotic vascular disease. Elevated NP levels may serve as an early warning system to help to identify patients at high risk for cardiac events. Recombinant human ANP (carperitide) and BNP (nesiritide) are useful for management of acutely decompensated HF; these drugs are also being investigated for myocardial and renal protection in the setting of cardiac surgery and for prevention of cardiac remodeling.The clinical application of NPs is expanding rapidly. Recent basic science and clinical research findings continue to improve our understanding of the NP system and guide use of ANP and BNP as biomarkers and as therapeutic agents.

The uterus and the heart share a common structure and may remodel in a similar fashion, albeit temporally distinct. The authors investigated the prevalence of systemic hypertension in women with uterine leiomyomata (fibroids) and compared the prevalence in women undergoing hysterectomy for other reasons as well as in age‐matched women from the National Health and Nutrition Examination Survey III (NHANES III). A total of 584 women, 205 with leiomyomata in 1999 (group A) and 379 who underwent hysterectomy for a variety of reasons in 2000 (group B) at Advocate Christ Medical Center were included. Presence of leiomyomata was confirmed by pathology. Hypertension was defined as blood pressure ≥140/90 mm Hg or history of hypertension with or without medication use. The prevalence of hypertension in group A and B patients with leiomyomata compared with NHANES III overall was 48.6% vs. 24% (p

The American College of Cardiology (ACC)/American Heart Association (AHA) Task Force on Practice Guidelines regularly reviews existing guidelines to determine when an update or full revision is needed. This process gives priority to areas where major changes in text, particularly recommendations

The Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) trial demonstrated increased 1- and 2-year survival and improved quality of life for end-stage heart failure patients implanted with the HeartMate VE Left Ventricular Assist Device (LVAD) (Thoratec Corporation, Pleasanton, CA) compared with optimal medical management. This is the first report of Destination Therapy (DT) experience since REMATCH and incorporates improvements with the HeartMate XVE LVAD and patient management. Forty-two patients with end-stage heart failure at higher volume institutions were supported with the LVAD over a duration of 26.7 patient years (mean 232 days). Compared with REMATCH, DT patients had a 40% lower rate of death (0.49 vs. 0.84 deaths per patient year). Kaplan-Meier estimates of survival in the DT and REMATCH LVAD groups at 30 days were 90% and 81%, and at 1 year were 61% and 52%. The death rate due to sepsis was 8.3 times lower in DT patients (risk ratio, 0.12; 95% confidence interval, 0.02-0.90). DT patients were 2.1 times less likely to experience an adverse event (risk ratio, 0.47; 95% confidence interval, 0.35-0.63). These results demonstrate continued improvement with outcomes in long-term DT with LVADs. Given that these DT patients were similar to those in the REMATCH trial, the improved outcomes likely reflect improvements in the HeartMate XVE LVAD and experience with patient management.

The Prospective Randomized Outcomes study of Acutely decompensated Congestive heart failure Treated Initially as Outpatients with Nesiritide (PROACTION) trial evaluated the safety of nesiritide administration in the emergency department in patients with decompensated heart failure. Patients (N=237) were treated for at least 12 hours with standard care plus either intravenous nesiritide or placebo. Compared to placebo, nesiritide favorably decreased systolic blood pressure (SBP) in patients with elevated baseline SBP, without negatively impacting patients with lower baseline SBP (SBP,140 mm Hg: nesiritide, -28.7 mm Hg, vs placebo, -8.4 mm Hg [P.001]; SBP, 101-140 mm Hg: nesiritide, -12.3 mm Hg, vs placebo, -5 mm Hg [P.017]; SBP,101 mm Hg: nesiritide, -1.2 mm Hg vs placebo, +16.7 mm Hg [P.03]). Both treatment groups had similar incidences of symptomatic and asymptomatic hypotension. These data demonstrate that early administration of nesiritide in the emergency department is a safe and effective treatment of heart failure.

Background Enhanced external counterpulsation (EECP) is effective in treating angina in coronary artery disease patients. Whether EECP produces similar immediate and sustained benefits and freedom from adverse events (MACE) at 1 year in patients with severe systolic dysfunction versus diastolic dysfunction is unknown. Methods and results Data of 746 angina patients with a history of heart failure enrolled in the International EECP Registry were divided into 2 groups: left ventricular ejection fraction (LVEF) ≤35% (S) and LVEF >35% (D). Mean LVEF was 51.0 ± 10.2% in diastolic dysfunction (n = 391) versus 26.3 ± 6.9% in systolic dysfunction (n = 355). At baseline, 92.0% of diastolic dysfunction and 90.9% of systolic had Canadian Cardiovascular Society Class III/IV angina with similar number of anginal episodes and nitroglycerin use. After 32 hours of EECP, angina was reduced by ≥1 class in 71.9% of diastolic versus 72.2% of systolic with similar decreases in anginal episodes and nitroglycerin use. At 1-year 78.1% of diastolic and 75.8% of systolic have less angina than pre-EECP. MACE at 1 year was also comparable (24.4 versus 23.8%). Conclusions The benefits of EECP in heart failure patients were similar regardless of diastolic or systolic dysfunction. The improvement was sustained at 1 year with similar MACE.

This study evaluated left ventricular diastolic function with Doppler echocardiography before and after statin therapy. Statin therapy worsened diastolic parameters in most patients; coenzyme Q(10) supplementation in patients with worsening diastolic function with statin therapy improved parameters of diastolic function.

Among the most exciting developments in the field of heart failure in recent times has been the rediscovery of the natriuretic peptide system and its pleuripotent effects on cardiac structure and function. This is particularly true of its natriuretic and hemodynamic effects. There has been an explosion of the knowledge base seeking to understand the wide range of homeostatic, regulatory, and counter-regulatory functions in which the natriuretic peptide system participates. Additional interest has been stimulated by advances in technology such as point-of-care and core laboratory BNP assays and the use of the recombinant B-type natriuretic peptide nesiritide as a treatment option. Despite this recent interest, the available literature lacks a comprehensive expert review of the current science and roles of natriuretic peptides for diagnostic, prognostic, screening, treatment monitoring, and therapeutic purposes. More importantly, a summary updating and guiding the clinician on most of these advances was lacking. An expert Consensus Panel with basic, methodological, and clinical expertise was convened to summarize current knowledge in these areas and the findings and consensus statements are contained herein.

The Follow-Up Serial Infusions of Nesiritide pilot study was designed to assess the safety and tolerability of outpatient serial infusions of nesiritide in 210 patients with decompensated heart failure who were randomly assigned to usual care only or usual care plus weekly infusions of nesiritide at dosages of 0.005 or 0.01 microg/kg/min for 12 weeks. The mean age +/- SD of the entire population was 67 +/- 13 years; 70% were men, and 80% were white. Mean baseline serum creatinine levels were 1.8 +/- 0.7 mg/dl, and mean left ventricular ejection fraction was 0.28 +/- 0.15%. Diabetes mellitus was present in 106 patients (50%), and atrial arrhythmias were present in 100 patients (48%). A totalof 1,645 nesiritide infusions was administered; 11 (1%) were discontinued due to an adverse event. All treatment groups had a similar frequency of adverse events and experienced improvements in quality of life. Administration of nesiritide resulted in acute decreases in aldosterone and endothelin-1 concentrations. Although there were no statistically significant differences among groups by outcome, prospectively defined higher risk subgroups demonstrated significant decreases in cardiovascular events. These results demonstrate the safety and feasibility of administering nesiritide in an outpatient setting. Additional studies are needed to determine the effect of outpatient serial infusions of nesiritide on rates of morbidity and mortality in advanced heart failure.

Heart failure (HF) management has seen enormous advances in the past two decades, including publication of HF management guidelines targeted at further reduction of morbidity and mortality. Nonetheless, the morbidity of HF has steadily increased and now represents one of the largest health care expenditures in this country. Because hospitalization for HF is most likely for patients with more advanced HF, they share a disproportionate burden of the hospitalization costs and will require treatment regimens beyond the current guidelines, if this burden is to be alleviated. In June 2004, a group of investigators who helped establish the natriuretic peptide treatment paradigm, met to discuss the potential role of nesiritide as an outpatient treatment option for patients with symptomatic HF who were at high risk for repeated admissions, a syndrome now described as "chronic decompensated HF." This report presents their considerations on the contribution of natriuretic peptide physiology to the amelioration of progressive left ventricular dysfunction, the therapeutic use of B-type natriuretic peptide, and its potential application to the outpatient management of acute and chronic decompensated HF. The use of outpatient IV nesiritide was considered a promising treatment option for symptomatic chronic decompensated HF patients that merits further investigation. Such an approach, once validated, should be integrated into an evidence-based HF disease management program.

Invasive pulmonary artery catheterization has historically been the method of choice for the evaluation of hemodynamic status. Impedance cardiography (ICG) is an accurate, noninvasive technique to obtain hemodynamic status information without the risk and cost associated with invasive methods. The purpose of this prospective, observational study was to determine whether the availability of ICG could decrease the need for placement of a pulmonary artery catheter in critically ill patients in coronary care units. After the need for hemodynamic data was determined, ICG parameters were provided to the attending physician who then decided whether pulmonary artery catheter insertion was still necessary. Of 107 subjects enrolled in the study, 14 (13%; 95% confidence interval, 7.3%–21.0%) were judged by the treating physicians to have indications for hemodynamic monitoring. In these subjects, the provision of ICG data allowed the physician to avoid placement of a pulmonary artery catheter in 10/14 patients (71%; 95% confidence interval, 41.9%–91.6%). When ICG was utilized, clinicians reported that the information was helpful in 10/10 patients (100%; 95% confidence interval, 74.1%–100.0%) and improved outcome in 6/10 patients (60%; 95% confidence interval, 26.2%–87.8%). ICG can replace the pulmonary artery catheter in coronary care unit patients, and clinicians utilizing ICG believe it aids medical decision making and improves patient outcomes. (CHF. 2004;10(2 suppl 2):17–21) © 2004 CHF, Inc.