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Journal Cover JACC : Heart Failure
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   Full-text available via subscription Subscription journal
   ISSN (Online) 2213-1779
   Published by American College of Cardiology Homepage  [1 journal]
  • Promoting Transparency in Trials Lessons From the COMPANION Investigators
    • Authors: Zeitler EP; Peterson ED.
      Abstract: Calls for increased transparency in the reporting and analysis of clinical trials have become commonplace (1). These have generally focused on “opening up” trial databases so that external investigators can revalidate the primary study findings and/or use the trial data for secondary hypothesis generation (2,3). At its core, however, the major goal of the open-science movement is to glean as much knowledge as is possible from every trial. This aim is certainly laudable, but this learning process may not necessarily require outside investigation. In fact, in this issue of JACC: Heart Failure, the members of the Study Steering Committee from the COMPANION (Comparison of Medical Therapy, Pacing and Defibrillation in Heart Failure) trial (4) “open up” and share reflections from their own trial experiences as well as new insights and hypotheses based on subsequent trial analysis.
      PubDate: Fri, 01 Jul 2016 00:00:00 GMT
  • Medicare Trends of Takotsubo Cardiomyopathy Outcomes Is it Just
           the Tip of an Iceberg'
    • Authors: Mahmoud AN; Saad M, Elgendy IY.
      Abstract: We have read with interest the work by Murugiah et al. (1) exploring the trends of diagnosis and outcomes of patients with principal and secondary diagnoses of Takotsubo cardiomyopathy (TTC) using Medicare fee-for-service database. The current study illustrated an increase in the trend of TTC diagnosis coinciding with enhanced awareness of this condition. The authors showed that the incidences of in-hospital, 30-day, and 1-year mortality in patients with TTC were less compared with patients with acute coronary syndrome. However, these incidences might be underestimated given how the authors defined patients with TTC in their cohort. The authors attempted to ensure an accurate diagnosis of TTC by ascertaining that all the patients who received the International Classification of Diseases-9 code of TTC had also received a procedure code of coronary angiography during the same hospitalization. Although this approach would be helpful in the accurate estimation of primary (principal) TTC trends, the same does not hold true for patients with secondary TTC and such an approach might be a source of unintentional selection bias in the current study. Secondary TTC usually occurs following a physical stressor that might be neurologic in nature (e.g., subarachnoid hemorrhage, intracranial hemorrhage, or acute ischemic stroke) (2,3). Multiple studies had shown that patients with secondary TTC carry different characteristics and worse outcomes compared with patients with primary TTC (3,4). Thus, such group of patients with TTC, by default, would have a lower chance of receiving a coronary angiography during their hospital stay, either because of the presence of a contraindication (e.g., subarachnoid hemorrhage or intracranial hemorrhage) or simply because they are clinically in unstable condition and at higher risk of complications to undergo any invasive procedure.
      PubDate: Fri, 01 Jul 2016 00:00:00 GMT
  • Reply BMI Is a Potential Confounder of Post-Partum Relaxin-2 and
           Short-Term Left Ventricular Function Following Peripartum Cardiomyopathy
    • Authors: Damp J; McNamara DM.
      Abstract: We read with appreciation Dr. Timpka’s comments on our paper (1). Dr. Timpka points out the important concept of an association of body mass index (BMI) with levels of Relaxin-2 during pregnancy and with left ventricular ejection fraction at 12 months in peripartum cardiomyopathy (PPCM). In our study population of patients with PPCM, there was not a clear correlation between BMI and Relaxin-2 levels, although this may have been caused, in part, by the relatively small number of patients. As Dr. Timpka points out, our investigator group is currently exploring the relationship further between BMI and recovery in this cohort of patients with PPCM. We acknowledge BMI as a potential confounder in our reported analysis in the relationship between Relaxin-2 and recovery and agree that this warrants further study. Future study would most ideally be done in larger cohorts and with BMI data before pregnancy, during pregnancy, and during follow-up.
      PubDate: Fri, 01 Jul 2016 00:00:00 GMT
  • The Year in Heart Failure Review 2015 to 2016
    • PubDate: Fri, 01 Jul 2016 00:00:00 GMT
  • BMI Is a Potential Confounder of Postpartum Relaxin-2 and Short-Term Left
           Ventricular Function Following Peripartum Cardiomyopathy
    • Authors: Timpka S.
      Abstract: In their recent publication, Damp et al. (1), reported that early postpartum levels of relaxin-2 are associated with better short-term left ventricular function in women with peripartum cardiomyopathy (PPCM). This is of potential interest given our incomplete understanding of the pathophysiology of PPCM. However, it is important to note that the investigators have not taken the women’s weight or body mass index (BMI) into account in their analyses. Relaxin-2 levels during pregnancy are inversely associated with maternal BMI from pre-pregnancy (2) and early gestation (3), whereas there are previous reports indicating that maternal BMI (non-obese vs. obese (4) and linearly (5), respectively) is inversely associated with left ventricular ejection fraction at 12 months following PPCM. Notably, the latter observations are based on the same clinical dataset as Damp et al. have based their analyses on (the IPAC [Investigations of Pregnancy-Associated Cardiomyopathy] study). As there is a large variation in the increase of relaxin-2 levels during pregnancy, it is plausible that the early post-partum levels of relaxin-2 reported by Damp et al. are correlated with the levels produced in late pregnancy. Maternal BMI could thus be an important confounder in the presented analyses on relaxin-2 and short-term left ventricular outcomes following PPCM. Preferably, maternal BMI as a potential confounder should be addressed in future investigations on the topic.
      PubDate: Fri, 01 Jul 2016 00:00:00 GMT
  • High-Sensitivity Troponin in the Triage of Acute Decompensated Heart
           Failure ∗
    • Authors: Jaffe AS; Morrow DA, Scirica BM.
      Abstract: Hospitalizations for acute decompensated heart failure (ADHF) account for the majority of >$30 billion spent on heart failure (HF) annually in the United States (1). Moreover, the evaluation of these patients adds nearly 1 million emergency department (ED) evaluations annually, and exacerbates ED overcrowding (2). Despite data suggesting that >50% of this population has a low risk of serious complications, >80% are admitted to the hospital (3). Low-risk patients with ADHF may be candidates for outpatient management and follow-up. However, to execute such a strategy, accurate risk stratification is essential. The report by Pang et al. (4) in this issue of JACC: Heart Failure addresses whether measurement of high-sensitivity cardiac troponin (hsTn) on ED arrival might identify low-risk patients with ADHF and potentially avoid hospitalizations. This approach shares some analogy to the “rule-out myocardial infarction” strategy in patients with chest pain. Given challenges in diagnosis, variability in prognosis, and pressures to reduce hospital admissions, an evidence-based strategy to drive triage and management decisions is appealing.
      PubDate: Fri, 01 Jul 2016 00:00:00 GMT
  • Decongestion in Acute Heart Failure Does the End Justify the Means'
    • Authors: Testani JM; ter Maaten JM.
      Abstract: Fluid overload and the resultant signs and symptoms, such as dyspnea, are the predominant factors precipitating a hospitalization for acute heart failure. The first-line treatment to relieve this congestion are loop diuretic agents, which are administered to more than 90% of patients hospitalized for acute heart failure (1). Heart failure guidelines recommend treatment with escalating doses of diuretic agents until decongestion is achieved (2,3). These practice patterns and recommendations are intriguing because there are biologically plausible mechanisms through which loop diuretic agents could directly worsen outcomes, and appropriately powered efficacy and safety studies are lacking.
      PubDate: Fri, 01 Jul 2016 00:00:00 GMT
  • Use of High-Sensitivity Troponin T to Identify Patients With Acute
           Heart Failure at Lower Risk for Adverse Outcomes An Exploratory
           Analysis From the RELAX-AHF Trial
    • Authors: Pang PS; Teerlink JR, Voors AA, et al.
      Abstract: ObjectivesThe aim of this study was to determine if a baseline high-sensitivity troponin T (hsTnT) value ≤99th percentile upper reference limit (0.014 μg/l [“low hsTnT”]) identifies patients at low risk for adverse outcomes.BackgroundApproximately 85% of patients who present to emergency departments with acute heart failure are admitted. Identification of patients at low risk might decrease unnecessary admissions.MethodsA post-hoc analysis was conducted from the RELAX-AHF (Serelaxin, Recombinant Human Relaxin-2, for Treatment of Acute Heart Failure) trial, which randomized patients within 16 h of presentation who had systolic blood pressure >125 mm Hg, mild to moderate renal impairment, and N-terminal pro–brain natriuretic peptide ≥1,600 ng/l to serelaxin versus placebo. Linear regression models for continuous endpoints and Cox models for time-to-event endpoints were used.ResultsOf the 1,076 patients with available baseline hsTnT values, 107 (9.9%) had low hsTnT. No cardiovascular (CV) deaths through day 180 were observed in the low-hsTnT group compared with 79 CV deaths (7.3%) in patients with higher hsTnT. By univariate analyses, low hsTnT was associated with lower risk for all 5 primary outcomes: 1) days alive and out of the hospital by day 60; 2) CV death or rehospitalization for heart failure or renal failure by day 60; 3) length of stay; 4) worsening heart failure through day 5; and 5) CV death through day 180. After multivariate adjustment, only 180-day CV mortality remained significant (hazard ratio: 0.0; 95% confidence interval: 0.0 to 0.736; p = 0.0234; C-index = 0.838 [95% confidence interval: 0.798 to 0.878]).ConclusionsNo CV deaths through day 180 were observed in patients with hsTnT levels ≤0.014 μg/l despite high N-terminal pro–brain natriuretic peptide levels. Low baseline hsTnT may identify patients with acute heart failure at very low risk for CV mortality.
      PubDate: Fri, 01 Jul 2016 00:00:00 GMT
  • In-Hospital Diuretic Agent Use and Post-Discharge Clinical Outcomes in
           Patients Hospitalized for Worsening Heart Failure Insights From the
           EVEREST Trial
    • Abstract: ObjectivesThe aim of this study was to characterize the association between decongestion therapy and 30-day outcomes in patients hospitalized for heart failure (HF).BackgroundLoop diuretic agents are commonly prescribed for the treatment of symptomatic congestion in patients hospitalized for HF, but the association between loop diuretic agent dose response and post-discharge outcomes has not been well characterized.MethodsCox proportional hazards models were used to estimate the association among average loop diuretic agent dose, congestion status at discharge, and 30-day post-discharge all-cause mortality and HF rehospitalization in 3,037 subjects hospitalized with worsening HF enrolled in the EVEREST (Efficacy of Vasopressin Antagonism in Heart Failure: Outcome Study With Tolvaptan) study.ResultsIn univariate analysis, subjects exposed to high-dose diuretic agents (≥160 mg/day) had greater risk for the combined outcome than subjects exposed to low-dose diuretic agents (18.9% vs. 10.0%; hazard ratio: 2.00; 95% confidence interval: 1.64 to 2.46; p < 0.0001). After adjustment for pre-specified covariates of disease severity, the association between diuretic agent dose and outcomes was not significant (hazard ratio: 1.11; 95% confidence interval: 0.89 to 1.38; p = 0.35). Of the 3,011 subjects with clinical assessments of volume status, 2,063 (69%) had little or no congestion at hospital discharge. Congestion status at hospital discharge did not modify the association between diuretic agent exposure and the combined endpoint (p for interaction = 0.84).ConclusionsShort-term diuretic agent exposure during hospital treatment for worsening HF was not an independent predictor of 30-day all-cause mortality and HF rehospitalization in multivariate analysis. Congestion status at discharge did not modify the association between diuretic agent dose and clinical outcomes.
      PubDate: Fri, 01 Jul 2016 00:00:00 GMT
  • The Promise of Recovery ∗
    • Authors: Birks EJ.
      Abstract: Chronic heart failure is a progressive disorder characterized by adverse structural, cellular, and molecular left ventricular remodeling. Advanced heart failure has generally been thought of as an irreversible process, but mechanical unloading with a left ventricular assist device (LVAD), particularly if combined with aggressive reverse remodeling heart failure medications, has been shown to lead to a reversal of the chronic heart failure phenotype, a process called “reverse remodeling.” Reverse remodeling refers to the regression of pathologic myocardial hypertrophy and improvement in LV chamber size that can occur in response to the treatment of heart failure. Myocardial recovery is the normalization of structural, molecular, and hemodynamic changes sufficient to allow sustained explantation of the LVAD.
      PubDate: Fri, 01 Jul 2016 00:00:00 GMT
  • Myocardial Structural and Functional Response After Long-Term Mechanical
           Unloading With Continuous Flow Left Ventricular Assist Device Axial
           Versus Centrifugal Flow
    • Authors: Al-Sarie M; Rauf A, Kfoury AG, et al.
      Abstract: ObjectivesThe aim of this study was to assess the impact of continuous-flow left ventricular assist device (LVAD) type—axial flow (AX) versus centrifugal flow (CR)—on myocardial structural and functional response following mechanical unloading.BackgroundThe use of continuous-flow LVADs is increasing steadily as a therapeutic option for patients with end-stage heart failure who are not responsive to medical therapy. Whether the type of mechanical unloading influences the myocardial response is yet to be determined.MethodsA total of 133 consecutive patients with end-stage heart failure implanted with continuous-flow LVADs (AX, n = 107 [HeartMate II Thoratec Corporation, Pleasanton, California]; CR, n = 26 [HeartWare, HeartWare International, Framingham, Massachusetts]) were prospectively studied. Echocardiograms were obtained pre-LVAD implantation and then serially at 1, 2, 3, 4, 6, 9, and 12 months post-implantation.ResultsThe 2 pump types led to similar degrees of mechanical unloading as assessed by invasive hemodynamic status and frequency of aortic valve opening. Myocardial structural and functional parameters showed significant improvement post-LVAD in both AX and CR groups. Left ventricular ejection fraction increased significantly from a mean of 18% to 28% and 26% post-LVAD in the AX and CR groups, respectively. Left ventricular end-systolic volume index and left ventricular end-diastolic volume index decreased significantly as early as 30 days post-implantation in the 2 groups. The degree of myocardial structural or functional response between patients in the AX or CR groups appeared to be comparable.ConclusionsLong-term mechanical unloading induced by AX and CR LVADs, while operating within their routine clinical range, seems to exert comparable effects on myocardial structural and functional parameters.
      PubDate: Fri, 01 Jul 2016 00:00:00 GMT
  • Evolving Challenges for Targeting Metabolic Abnormalities in Heart Failure
    • Authors: Margulies KB.
      Abstract: With limited capacity to store adenosine triphosphate (ATP) in the form of glycogen and phosphocreatine, the heart is continuously dependent on ATP synthesis to maintain force generation, myofibrillar relaxation, and ionic homeostasis. The ability of normal myocardium to adapt its substrate use to meet these essential demands has been appreciated for over half a century. Central in this adaptation is the flexible metabolic circuitry that is capable of switching preferred energy substrates and regulating pathways of oxidative and nonoxidative energy transduction to optimally adapt to physiological demands (1). Normally, fatty acids (FAs) are the predominant energetic substrate for the heart; their beta-oxidation provides 60% to 70% of myocardial ATP, with 30% of ATP derived from glucose.
      PubDate: Fri, 01 Jul 2016 00:00:00 GMT
  • Effects of the Novel Long-Acting GLP-1 Agonist, Albiglutide, on Cardiac
           Function, Cardiac Metabolism, and Exercise Capacity in Patients With
           Chronic Heart Failure and Reduced Ejection Fraction
    • Authors: Lepore JJ; Olson E, Demopoulos L, et al.
      Abstract: ObjectivesThis study sought to determine if glucagon-like peptide (GLP)-1 ameliorates myocardial metabolic abnormalities in chronic heart failure.BackgroundAlbiglutide (GSK716155) is a GLP-1 agonist indicated for type 2 diabetes.MethodsWe performed a randomized, placebo-controlled study evaluating 12 weeks of albiglutide in New York Heart Association II or III subjects with ejection fraction 
      PubDate: Fri, 01 Jul 2016 00:00:00 GMT
  • Brain Natriuretic Peptide Treatment and Heart Failure Prevention
           Reliving the Mistakes of the Past or Charting
           a New Course for the Future' ∗
    • Authors: Sharma A; Felker G.
      Abstract: “What’s past is prologue”—William Shakespeare, The Tempest (1)
      PubDate: Fri, 01 Jul 2016 00:00:00 GMT
  • Patient and Facility Variation in Costs of VA Heart Failure Patients
    • Authors: Yoon J; Fonarow GC, Groeneveld PW, et al.
      Abstract: ObjectivesThis study sought to determine the variation in annual health care costs among patients with heart failure in the Veterans Affairs (VA) system.BackgroundHeart failure is associated with considerable use of health care resources, but little is known about patterns in patient characteristics related to higher costs.MethodsWe obtained VA utilization and cost records for all patients with a diagnosis of heart failure in fiscal year 2010. We compared total VA costs by patient demographic factors, comorbid conditions, and facility where they were treated in bivariate analyses. We regressed total costs on patient factors alone, VA facility alone, and all factors combined to determine the relative contribution of patient factors and facility to explaining cost differences.ResultsThere were 117,870 patients with heart failure, and their mean annual VA costs were $30,719 (SD 49,180) with more than one-half of their costs from inpatient care. Patients at younger ages, of Hispanic or black race/ethnicity, diagnosed with comorbid drug use disorders, or who died during the year had the highest costs (all p < 0.01). There was variation in costs by facility as mean adjusted costs ranged from approximately $15,000 to $48,000. In adjusted analyses, patient factors alone explained more of the variation in health care costs (R2 = 0.116) compared with the facility where the patient was treated (R2 = 0.018).ConclusionsA large variation in costs of heart failure patients was observed across facilities, although this was explained largely by patient factors. Improving the efficiency of VA resource utilization may require increased scrutiny of high-cost patients to determine if adequate value is being delivered to those patients.
      PubDate: Fri, 01 Jul 2016 00:00:00 GMT
  • Chronic Peptide Therapy With B-Type Natriuretic Peptide in Patients With
           Pre-Clinical Diastolic Dysfunction (Stage B Heart Failure)
    • Authors: Wan S; McKie PM, Schirger JA, et al.
      Abstract: ObjectivesThis study determined whether there is development of tachyphylaxis to enhancement of cardiorenal response to acute volume loading (AVL) with B-type natriuretic peptide (BNP) after 12-week, twice-daily subcutaneous BNP administration in patients with preclinical diastolic dysfunction (PDD).BackgroundPDD is characterized by normal systolic function and moderate or severe diastolic dysfunction but no symptoms of heart failure (HF). Impairment in cardiorenal endocrine response to stress by AVL exists in PDD and is corrected by acute administration of subcutaneous BNP.MethodsA double-blinded, placebo-controlled proof-of-concept study was conducted to compare 12 weeks of twice daily subcutaneous BNP, 10 μg/kg (n = 24), versus placebo (n = 12) in PDD. Subjects underwent 2 study visits, at baseline and after 12 weeks. At each study visit, echocardiography, renal, and neurohumoral assessments were performed before and after intravascular AVL.ResultsAmong those with PDD, there was a statistically significant improvement in diastolic function after 12 weeks of BNP, as measured by a decrease in the Doppler E/e′ ratio (where E is early mitral inflow velocity and e′ is mitral annulus early diastolic motion) (p = 0.004) and improvement of diastolic dysfunction grade (p = 0.008). After 12 weeks, there was statistically significantly greater sodium excretion, urine flow, and urinary cyclic guanosine monophosphate excretion to AVL (all p < 0.001), as well as a trend toward greater glomerular filtration rate (p = 0.050) in the BNP group as compared to the placebo group.ConclusionsIn subjects with PDD, chronic BNP administration resulted in sustained improvement in diastolic function without development of tachyphylaxis to the enhancement of cardiorenal response to volume expansion with BNP. (Human Brain Natriuretic Peptide [BNP] [or Nesiritide] to Help Heart, Kidney and Humoral Function; NCT00405548)
      PubDate: Fri, 01 Jul 2016 00:00:00 GMT
  • Lessons Learned and Insights Gained in the Design, Analysis, and
           Outcomes of the COMPANION Trial
    • Authors: Bristow MR; Saxon LA, Feldman AM, et al.
      Abstract: COMPANION (Comparison of Medical Therapy, Pacing and Defibrillation in Heart Failure), the first cardiac resynchronization therapy (CRT)–heart failure mortality and morbidity controlled clinical trial planned, conducted, and reported, was a randomized, 3-arm study that compared CRT delivered by a biventricular pacemaker (CRT-P) or a CRT defibrillator device (CRT-D) with optimal pharmacological therapy alone. The patient population had advanced chronic heart failure with QRS interval prolongation ≥120 ms and reduced left ventricular ejection fraction (heart failure with reduced ejection fraction). COMPANION had a composite hospitalization and mortality endpoint as the primary outcome measure but was also powered for mortality as the first secondary endpoint. The conduct of COMPANION was challenged by important issues that arose during the trial, the most important of which was U.S. Food and Drug Administration approval of CRT devices. Along with other challenges, this issue was appropriately dealt with by the Steering Committee and the Data and Safety Monitoring Committee and did not negatively affect trial results or conclusions. The authors report here updated analyses from the study, which are consistent with previously published results indicating that CRT-P or CRT-D has favorable effects on heart failure morbidity and mortality in a patient population “precision” selected by the surrogate marker of increased QRS interval duration. New analyses indicate that increasing the number of classes of neurohormonal inhibitor concurrent therapy has a positive effect on CRT mortality reduction. Hypothesis-generating new findings are that in patients receiving beta-blocker therapy, the mortality reduction advantage of CRT-D versus CRT-P may be minimized or eliminated and that there may be adverse effects of CRT-D defibrillator shocks on pump failure–related outcomes.
      PubDate: Fri, 01 Jul 2016 00:00:00 GMT
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