Abstract Background Classification of chronic heart failure (HF) is on the basis of criteria that may not adequately capture disease heterogeneity. Improved phenotyping may help inform research and ...therapeutic strategies. Objectives This study used cluster analysis to explore clinical phenotypes in chronic HF patients. Methods A cluster analysis was performed on 45 baseline clinical variables from 1,619 participants in the HF-ACTION (Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training) study, which evaluated exercise training versus usual care in chronic systolic HF. An association between identified clusters and clinical outcomes was assessed using Cox proportional hazards modeling. Differential associations between clinical outcomes and exercise testing were examined using interaction testing. Results Four clusters were identified (ranging from 248 to 773 patients in each), in which patients varied considerably among measures of age, sex, race, symptoms, comorbidities, HF etiology, socioeconomic status, quality of life, cardiopulmonary exercise testing parameters, and biomarker levels. Differential associations were observed for hospitalization and mortality risks between and within clusters. Compared with cluster 1, risk of all-cause mortality and/or all-cause hospitalization ranged from 0.65 (95% confidence interval 95% CI: 0.54 to 0.78) for cluster 4 to 1.02 (95% CI: 0.87 to 1.19) for cluster 3. However, for all-cause mortality, cluster 3 had a disproportionately lower risk of 0.61 (95% CI: 0.44 to 0.86). Evidence suggested differential effects of exercise treatment on changes in peak oxygen consumption and clinical outcomes between clusters (p for interaction <0.04). Conclusions Cluster analysis of clinical variables identified 4 distinct phenotypes of chronic HF. Our findings underscore the high degree of disease heterogeneity that exists within chronic HF patients and the need for improved phenotyping of the syndrome. (Exercise Training Program to Improve Clinical Outcomes in Individuals With Congestive Heart Failure; NCT00047437 )
In October 2008, in a public forum organized by the Cardiac Safety Research Consortium and the Health and Environmental Sciences Institute, leaders from government, the pharmaceutical industry, and ...academia convened in Bethesda, MD, to discuss current challenges in evaluation of short- and long-term cardiovascular safety during drug development. The current paradigm for premarket evaluation of cardiac safety begins with preclinical animal modeling and progresses to clinical biomarker or biosignature assays. Preclinical evaluations have clear limitations but provide an important opportunity to identify safety hazards before administration of potential new drugs to human subjects. Discussants highlighted the need to identify, develop, and validate serum and electrocardiogram biomarkers indicative of early drug-induced myocardial toxicity and proarrhythmia. Specifically, experts identified a need to build consensus regarding the use and interpretation of troponin assays in preclinical evaluation of myocardial toxicity. With respect to proarrhythmia, the panel emphasized a need for better qualitative and quantitative biomarkers for arrhythmogenicity, including more streamlined human thorough QT study designs and a universal definition of the end of the T wave. Toward many of these ends, large shared data repositories and a more seamless integration of preclinical and clinical testing could facilitate the development of novel approaches to both cardiac safety biosignatures. In addition, more thorough and efficient early clinical studies could enable better estimates of cardiovascular risk and better inform phase II and phase III trial design. Participants also emphasized the importance of establishing formal guidelines for data standards and transparency in postmarketing surveillance. Priority pursuit of these consensus-based directions should facilitate both safer drugs and accelerated access to new drugs, as concomitant public health benefits.
Abstract Background This study was undertaken to identify predictors of hospital length of stay (LOS) for heart failure (HF) patients using clinical variables available at the time of admission and ...hospital characteristics. Methods and Results A cohort of 70,094 HF patients discharged to home from 246 hospitals participating in the Get With The Guidelines–Heart Failure was analyzed for admission predictors for LOS. The analysis incorporated patient characteristics (PC) first, then added hospital characteristics (HC) followed by standard laboratory evaluations (SL), including troponin and brain natriuretic peptide (BNP). There were 31,995 patients (45.6%) with LOS < 4 days, 26,750 (38.2%) with LOS 4 to 7 days, and 11,349 (16.2%) with LOS > 7 days. Patients with longer LOS had more comorbidities and a higher severity of disease on admission. Overall models explained a modest amount of LOS variation, with an r2 of 4.8%, with PC responsible for 1.3% of variation and together with SL explained 2.2% of variation. HC did not change the variation. Conclusions Based on admission vital signs and BNP levels, patients with longer LOS have more comorbidities and a higher disease severity. The ability to risk stratify for LOS based on patient admission and hospital characteristics is limited.
This cross-sectional study examined the burden of cardiovascular diseases (CVDs) using serum 25-hydroxyvitamin D (25OHD) and prevalence of hypovitaminosis D in adults with CVDs using data from NHANES ...2001 to 2004. Serum 25(OH)D levels were divided into 3 categories (≥30, 20 to 29, and <20 ng/ml), and hypovitaminosis D was defined as vitamin D <30 ng/ml. Of 8,351 adults who had 25(OH)D measured, mean 25(OH)D was 24.3 ng/ml, and the prevalence of hypovitaminosis D was 74%. The burden of CVDs increased with lower 25(OH)D categories, with 5.3%, 6.7%, and 7.3% coronary heart disease; 1.5%, 2.4%, and 3.2% heart failure; 2.5%, 2.0%, and 3.2% stroke; and 3.6%, 5.0%, and 7.7% peripheral arterial disease. Across all CVDs, hypovitaminosis D was more common in blacks than Hispanics or whites. Compared with persons at low risk for CVDs (68%), it was more prevalent in those at high risk (75%; odds ratio OR 1.32, 95% confidence interval CI 1.05 to 1.67), with coronary heart disease (77%; OR 1.48, 95% CI 1.14 to 1.91), and both coronary heart disease and heart failure (89%; OR 3.52, 95% CI 1.58 to 7.84) after controlling for age, race, and gender. In conclusion, hypovitaminosis D was highly prevalent in US adults with CVDs, particularly those with both coronary heart disease and heart failure.
Older patients with acute decompensated heart failure (ADHF) have persistently poor outcomes including frequent rehospitalization despite guidelines-based therapy. We hypothesized that such patients ...have multiple, severe impairments in physical function, cognition, and mood that are not addressed by current care pathways. We prospectively examined frailty, physical function, cognition, mood, and quality of life in 27 consecutive older patients with ADHF at 3 medical centers and compared these with 197 participants in 3 age-matched cohorts: stable heart failure (HF) with preserved ejection fraction (n = 80), stable HF with reduced ejection fraction (n = 56), and healthy older adults (n = 61). Based on Fried criteria, frailty was present in 56% of patients with ADHF versus 0 for the age-matched chronic HF and health cohorts. Patients with ADHF had markedly reduced Short Physical Performance Battery score (5.3 ± 2.8) and 6-minute walk distance (178 ± 102 m) (p <0.001 vs other cohorts), with severe deficits in all domains of physical function: balance, mobility, strength, and endurance. In the patients with ADHF, cognitive impairment (78%) and depression (30%) were common, and quality of life was poor. In conclusion, older patients with ADHF are frequently frail with severe and widespread impairments in physical function, cognition, mood, and quality of life that may contribute to their persistently poor outcomes, are frequently unrecognized, are not addressed in current ADHF care paradigms, and are potentially modifiable with targeted interventions.
Highlights • Most analyses about HF patients are skewed to the elderly. • ASCEND-HF provided the chance to examine a broad age group of HF patients. • Death and rehospitalization risk decreases as ...age increases up to 55 years. • Death and rehospitalization risk increases after age 55. • Different interventions may be needed in different age groups to reduce risk.
Disease management programs that target patients with the highest risk of subsequent costs may help payers and providers control health care costs, but identifying these patients prospectively is ...challenging. We hypothesized that medical history and clinical data from a heart failure registry could be used to prospectively identify patients with heart failure most likely to incur high costs. We linked Medicare inpatient claims to clinical registry data for patients with heart failure and calculated total Medicare costs during the year after the index heart failure hospitalization. We defined patients as having high costs if they were in the upper 5% (>$76,500) of the distribution. We used logistic regression models to identify patient and clinical characteristics associated with high costs. Costs for 40,317 patients in the study varied widely. Patients in the upper 5% of the cost distribution incurred mean costs of $117,193 ± 55,550 during 1 year of follow-up compared to $17,086 ± 17,792 for the lower-cost group. Demographic and clinical characteristics associated with high costs included younger age and black race; history of anemia, chronic obstructive pulmonary disease, ischemic heart disease, diabetes mellitus, or peripheral vascular disease; serum creatinine level; and systolic blood pressure at admission. Mean 1-year Medicare costs for patients whom the model predicted would exceed the high-cost threshold were >2 times the costs for patients below the threshold. In conclusion, a model based on variables from clinical registries can identify a group of patients with heart failure who on average will incur higher costs in the first year after hospitalization.
End-of-Life Care in Patients With Heart Failure Whellan, David J., MD, MHS; Goodlin, Sarah J., MD; Dickinson, Michael G., MD ...
Journal of cardiac failure,
02/2014, Volume:
20, Issue:
2
Journal Article
Peer reviewed
Abstract Stage D heart failure (HF) is associated with poor prognosis, yet little consensus exists on the care of patients with HF approaching the end of life. Treatment options for end-stage HF ...range from continuation of guideline-directed medical therapy to device interventions and cardiac transplantation. However, patients approaching the end of life may elect to forego therapies or procedures perceived as burdensome, or to deactivate devices that were implanted earlier in the disease course. Although discussing end-of-life issues such as advance directives, palliative care, or hospice can be difficult, such conversations are critical to understanding patient and family expectations and to developing mutually agreed-on goals of care. Because patients with HF are at risk for rapid clinical deterioration or sudden cardiac death, end-of-life issues should be discussed early in the course of management. As patients progress to advanced HF, the need for such discussions increases, especially among patients who have declined, failed, or been deemed to be ineligible for advanced HF therapies. Communication to define goals of care for the individual patient and then to design therapy concordant with these goals is fundamental to patient-centered care. The objectives of this white paper are to highlight key end-of-life considerations in patients with HF, to provide direction for clinicians on strategies for addressing end-of-life issues and providing optimal patient care, and to draw attention to the need for more research focusing on end-of-life care for the HF population.
Abstract Background The safety and efficacy of aerobic exercise in heart failure (HF) patients with atrial fibrillation (AF) has not been well evaluated. Objectives This study examined whether ...outcomes with exercise training in HF vary according to AF status. Methods HF-ACTION (Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training) randomized 2,331 ambulatory HF patients with ejection fraction ≤35% to exercise training or usual care. We examined clinical characteristics and outcomes (mortality/hospitalization) by baseline AF status (past history of AF or AF on baseline electrocardiogram vs. no AF) using adjusted Cox models and explored an interaction with exercise training. We assessed post-randomization AF events diagnosed via hospitalizations for AF and reports of serious arrhythmia caused by AF. Results Of 2,292 patients with baseline rhythm data, 382 (17%) had AF, 1,602 (70%) had sinus rhythm, and 308 (13%) had “other” rhythm. Patients with AF were older and had lower peak V o2 . Over a median follow-up of 2.6 years, AF was associated with a 24% per year higher rate of mortality/hospitalization (hazard ratio HR: 1.53; 95% confidence interval CI: 1.34 to 1.74; p < 0.001) in unadjusted analysis; this did not remain significant after adjustment (HR: 1.15; 95% CI: 0.98 to 1.35; p = 0.09). There was no significant difference in AF event rates by randomized treatment assignment in the overall population or by baseline AF status (all p > 0.10). There was no interaction between AF and exercise training on measures of functional status or clinical outcomes (all p > 0.10). Conclusions AF in patients with chronic HF was associated with older age, reduced exercise capacity at baseline, and a higher overall rate of clinical events, but not a differential response to exercise training for clinical outcomes or changes in exercise capacity. (Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training HF-ACTION; NCT00047437 )
Abstract Background Prognosis in heart failure (HF) patients is commonly assessed based on clinical characteristics. The association between partner status and socioeconomic status (SES) and outcomes ...in chronic HF requires further study. Methods We performed a post-hoc analysis of HF-ACTION, which randomized 2331 HF patients with ejection fraction ≤35% to usual care +/− aerobic exercise training. We examined baseline quality of life and functional capacity and outcomes (all-cause mortality/hospitalization) by partner status and SES using adjusted Cox models and explored an interaction with exercise training. Outcomes were examined based on partner status, education level, annual income, and employment. Results Having a partner, education beyond high school, an income >$25,000, and being employed were associated with better baseline functional capacity and quality of life. Over a median follow-up of 2.5 years, higher education, higher income, being employed, and having a partner were associated with lower all-cause mortality/hospitalization. After multivariable adjustment, lower mortality was seen associated with having a partner (Hazard Ratio HR 0.91, 95% Confidence Interval CI: 0.81–1.03, P = .15) and more than a high school education (HR 0.91, CI: 0.80–1.02, P = .12), although these associations were not statistically significant. There was no interaction between any of these variables and exercise training on outcomes (all P > .5). Conclusions Having a partner and higher SES were associated with greater functional capacity and quality of life at baseline but were not independent predictors of long-term clinical outcomes in chronic HF patients. These findings provide information that may be considered as potential variables impacting outcomes.
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