Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients with Heart Failure (OPTIMIZE-HF): rationale and design

Heart failure (HF) affects >5 million patients in the United States, and its prevalence is increasing every year. Despite the compelling scientific evidence that angiotensin-converting enzyme inhibitors and β-blockers reduce hospitalizations and mortality rates in patients with HF, these lifesaving therapies continue to be underused. Several studies in a variety of clinical settings have documented that a significant proportion of eligible patients with HF are not receiving treatment with these guideline-recommended, evidence-based therapies. In patients hospitalized with HF, who are at particularly high risk for re-hospitalization and death, the initiation of β-blockers is often delayed because of concern that early initiation of these agents may exacerbate HF. Recent studies suggest that β-blockers can be safely and effectively initiated in patients with HF before hospital discharge and that clinical outcomes are improved. The Initiation Management Predischarge Process for Assessment of Carvedilol Therapy for Heart Failure (IMPACT-HF) trial demonstrated that pre-discharge initiation of carvedilol was associated with a higher rate of β-blocker use after hospital discharge, with no increase in hospital length of stay. In addition, there was no increase in the risk of worsening of HF. Studies of hospital-based management systems that rely on early (pre-discharge) initiation of evidence-based therapies for patients with cardiovascular disease have also found increases in post-discharge use of therapy and a reduction in the rates of mortality and hospitalization. On the basis of these pivotal studies, the Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients with Heart Failure (OPTIMIZE-HF) program is designed to improve medical care and education of hospitalized patients with HF and accelerate the initiation of evidence-based HF guideline recommended therapies by administering them before hospital discharge. A registry component, planned as the most comprehensive database of the hospitalized HF population focusing on admission to discharge and 60- to 90-day follow-up, is designed to evaluate the demographic, pathophysiologic, clinical, treatment, and outcome characteristics of patients hospitalized with HF. The ultimate aim of this program is to improve the standard of HF care in the hospital and outpatient settings and increase the use of evidence-based therapeutic strategies to save lives.     

Update on aldosterone antagonists use in heart failure with reduced left ventricular ejection fraction. Heart Failure Society of America Guidelines Committee

Aldosterone antagonists (or mineralocorticoid receptor antagonists [MRAs]) are guideline-recommended therapy for patients with moderate to severe heart failure (HF) symptoms and reduced left ventricular ejection fraction (LVEF), and in postmyocardial infarction patients with HF. The Eplerenone in Mild Patients Hospitalization and Survival Study in Heart Failure (EMPHASIS-HF) trial evaluated the MRA eplerenone in patients with mild HF symptoms. Eplerenone reduced the risk of the primary endpoint of cardiovascular death or HF hospitalization (hazard ratio [HR] 0.63, 95% confidence interval [CI] 0.54-0.74, P < .001) and all-cause mortality (adjusted HR 0.76, 95% CI 0.62-0.93, P < .008) after a median of 21 months. Based on EMPHASIS-HF, an MRA is recommended for patients with New York Heart Association (NYHA) Class II-IV symptoms and reduced LVEF (<35%) on standard therapy (Strength of Evidence A). Patients with NYHA Class II symptoms should have another high-risk feature to be consistent with the EMPHASIS-HF population (age >55 years, QRS duration >130 msec [if LVEF between 31% and 35%], HF hospitalization within 6 months or elevated B-type natriuretic peptide level). Renal function and serum potassium should be closely monitored. Dose selection should consider renal function, baseline potassium, and concomitant drug interactions. The efficacy of eplerenone in patients with mild HF symptoms translates into a unique opportunity to reduce morbidity and mortality earlier in the course of the disease.     

Indications for cardiac resynchronization therapy: 2011 update from the Heart Failure Society of America Guideline Committee

Cardiac resynchronization therapy (CRT) improves survival, symptoms, quality of life, exercise capacity, and cardiac structure and function in patients with New York Heart Association (NYHA) functional class II or ambulatory class IV heart failure (HF) with wide QRS complex. The totality of evidence supports the use of CRT in patients with less severe HF symptoms. CRT is recommended for patients in sinus rhythm with a widened QRS interval (≥150 ms) not due to right bundle branch block (RBBB) who have severe left ventricular (LV) systolic dysfunction and persistent NYHA functional class II-III symptoms despite optimal medical therapy (strength of evidence A). CRT may be considered for several other patient groups for whom evidence of benefit is clinically significant but less substantial, including patients with a QRS interval of ≥120 to <150 ms and severe LV systolic dysfunction who have persistent mild to severe HF despite optimal medical therapy (strength of evidence B), some patients with atrial fibrillation, and some with ambulatory class IV HF. Several evidence gaps remain that need to be addressed, including the ideal threshold for QRS duration, QRS morphology, lead placement, degree of myocardial scarring, and the modality for evaluating dyssynchrony. Recommendations will evolve over time as additional data emerge from completed and ongoing clinical trials.     

Therapeutic Range of Digoxin's Efficacy in Heart Failure: What Is the Evidence?

Clinical studies have solidified the utility of digoxin in patients with left ventricular dysfunction and normal sinus rhythm. No definitive data have been published to clarify the range of serum digoxin concentrations associated with clinical benefit. The traditional therapeutic range of 0.8-2.0 ng/ml was developed originally to classify digoxin toxicity, not efficacy. In addition, this reference range was used before publication of the Digitalis Investigators Group trial. Clinical and neurohormonal studies have attempted to characterize serum concentrations that are associated with clinical efficacy.     

Prognostic value of blood urea nitrogen in patients hospitalized with worsening heart failure: insights from the Acute and Chronic Therapeutic Impact of a Vasopressin Antagonist in Chronic Heart Failure (ACTIV in CHF) study

BackgroundHospitalization for acute decompensated heart failure (ADHF) is associated with a high postdischarge mortality and readmission rate. The association between baseline blood urea nitrogen (BUN) and clinical outcomes in patients admitted for ADHF was evaluated in a post-hoc analysis of the ACTIV in CHF trial.Methods and ResultsPatients were categorized into quartiles according to baseline BUN. Cox proportional hazards regression was used to test the association between BUN, mortality, and death or readmission within 60 days. Patients in the highest quartile (>40 mg/dL) had the highest 60-day mortality (14.3%, 9.3%, 4.0%, 0%, respectively; P < .001) and the highest rate of death or heart failure hospitalization (30.0%, 21.3% 18.4%, 8.6%; P < .001). After adjustment for covariates, BUN was a statistically significant predictor of both mortality and the composite endpoint of death or heart failure hospitalization at 60 days after hospital discharge. Serum creatinine and estimated creatinine clearance did not predict mortality after covariate adjustment.ConclusionsHigher baseline BUN is a powerful predictor of increased postdischarge mortality in patients hospitalized for heart failure, even in the absence of severe renal failure. Even mild to moderate elevations in baseline BUN were predictive. BUN remains an easily accessible risk stratification tool that physicians should closely monitor in the hospital setting.     

Predictors of delivery of hospital-based heart failure patient education: a report from OPTIMIZE-HF

BackgroundAlthough recent heart failure (HF) management guidelines recommend delivery of patient education and discharge instructions, little is known about predictors of delivery of these materials or how such materials relate to outpatient disposition postdischarge. This report assesses the degree to which the full set of HF discharge instructions and education comprising the Joint Commission on Accreditation of Healthcare Organizations process-of-care measure (HF-1) was provided, identifies factors predictive of use of HF-1, and determines if HF-1 predicts postdischarge outcome disposition in a registry and performance improvement (PI) program for patients hospitalized for HF.Methods and ResultsIn the Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients with Heart Failure (ie, OPTIMIZE-HF), of 33,681 patients from 259 US hospitals, 54% received HF-1. Some patient and site characteristics, such as symptoms on admission and performance of coronary angiography, were positively associated with delivery of the full set of HF-1 components, and others, such as African-American or Hispanic race and Midwest site location, were negatively associated with HF-1 delivery. However, delivery of the full set of HF-1 components was significantly more likely in the 46% of patients receiving PI tools (OR 2.23, 95% CI 2.12–2.35; P < .0001). Delivery of the full set of HF-1 components was significantly associated with use of specialty referral programs after discharge (P < .0001).ConclusionsDespite recommendations that complete instructions be given to patients with HF before hospital discharge, both PI tools to facilitate HF-1 and HF-1 itself are underused. Efforts should focus on strengthening processes and structures that will improve consistent delivery of HF-1 to all patients.     

Improving the use of evidence-based heart failure therapies in the outpatient setting: the IMPROVE HF performance improvement registry

Evidence-based consensus treatment guidelines are available to assist physicians with the management of chronic heart failure (HF). Although it has been generally presumed that physicians incorporate these treatment guidelines into clinical practice, the actual assimilation of evidence-based strategies and guidelines has been demonstrated to be less than ideal. Studies of HF care show that treatment guidelines are slowly adopted and inconsistently applied and, thus, often fail to lead to improvements in patient care and outcomes. There are a number of ongoing, large, national quality improvement registries that are following the clinical care and outcomes of inpatient HF treatment. However, to date, there have been no similar quality improvement registries in the outpatient arena. The Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting (IMPROVE HF) is the first large, comprehensive performance improvement registry designed to characterize the current outpatient management of systolic HF and assess the effect of practice-specific process improvement interventions consisting of education, specific clinical guidelines, reminder systems, benchmarked quality reports, and structured academic detailing on the use of evidence-based HF therapies. Seven performance measures to quantify the quality of outpatient HF care were explicitly developed by the IMPROVE HF Steering Committee. The primary objective is to observe, over the aggregate of IMPROVE HF practice sites, a relative > or = 20% improvement in at least 2 of the 7 performance measures at 24 months, compared with baseline. Deidentified clinical data from the medical records of a planned 43,000 patients from 160 US cardiology practices will be included in this study.