Quality Indicators for the Management of Heart Failure in Vulnerable Elders

Heart failure is a common medical condition that contributes to substantial morbidity and mortality in elderly persons and greatly affects public health. In the United States, an estimated 4.6 million persons have heart failure, and 400 000 to 700 000 new cases develop each year (1). The prevalence of heart failure increases with age: It is present in 2% of persons 40 to 59 years of age, more than 5% of persons 60 to 69 years of age, and 10% of persons 70 years of age or older. As the U.S. population ages, the incidence and prevalence of this disease are expected to increase markedly. Heart failure is the primary diagnosis for 875 000 hospitalizations annually, and it is the most common diagnosis among hospitalized patients 65 years of age or older. Heart failure is a proximate or secondary cause of death in approximately 250 000 people per year. The overall fatality rate is high: Twenty percent of patients die within the first year after diagnosis, and 50% die within 5 years (1). In 1998, the estimated annual direct cost of heart failure was $18.8 billion. Improving quality of care for heart failure may substantially decrease morbidity and mortality. This review investigates the relationship between processes and outcomes of care and identifies quality indicators that may be applied in evaluating vulnerable elders with heart failure. Methods The methods for developing these quality indicators, including literature review and expert panel consideration, are described in detail elsewhere in this issue (2). For heart failure, the structured literature review identified 274 titles, from which abstracts and articles that were relevant to this report were identified. On the basis of the literature and the author's expertise, 19 potential quality indicators were proposed. Heart failure may result from left ventricular systolic dysfunction, diastolic dysfunction, or both. Unless otherwise specified, the quality indicators apply both to patients with predominant diastolic dysfunction and those with predominant systolic dysfunction. Results Of the 19 potential quality indicators, 14 were judged valid by the expert panel process (see the quality indicators) and 5 were not accepted. The literature summaries that support each of the indicators judged to be valid by the expert panel process are described below. Quality Indicator 1 Angiotensin-Converting Enzyme Inhibitors for Asymptomatic Left Ventricular Dysfunction IF a vulnerable elder has asymptomatic left ventricular dysfunction with a left ventricular ejection fraction of 40% or less, THEN an angiotensin-converting enzyme (ACE) inhibitor should be offered BECAUSE ACE inhibitor therapy reduces the incidence of new-onset symptomatic heart failure among patients with asymptomatic left ventricular dysfunction and decreases mortality among elderly patients who have had myocardial infarction. Supporting Evidence. The literature search identified three prospective, randomized, double-blind, placebo-controlled trials of ACE inhibitors to prevent heart failure among patients with asymptomatic left ventricular dysfunction: the Studies of Left Ventricular Dysfunction prevention trial (3), the Survival and Ventricular Enlargement trial (4), and the Trandolapril Cardiac Evaluation trial (5). Since the development of these indicators, the Heart Outcomes Prevention Evaluation trial has demonstrated the efficacy of ACE inhibitors in preventing heart failure in patients with vascular disease or diabetes (6). The results of these four studies are shown in Table 1. All studies reported large, statistically significant reductions in mortality or development of symptomatic heart failure. Table 1. Major Placebo-Controlled Trials of Angiotensin-Converting Enzyme Inhibitor Therapy in Patients with Diminished Left Ventricular Function or at High Cardiovascular Risk With the exception of the Heart Outcomes Prevention Evaluation trial, randomized clinical trials have not studied patients older than 80 years of age. Angiotensin-receptor antagonists were deemed to satisfy this indicator pending further data from clinical trials (see Quality Indicator 2). Quality Indicator 2 ACE Inhibitors for Symptomatic Heart Failure IF a vulnerable elder has symptomatic heart failure and a left ventricular ejection fraction of 40% or less, THEN he or she should be offered treatment with an ACE inhibitor BECAUSE ACE inhibitors have been demonstrated to reduce mortality, decrease symptoms, and improve functional status. Supporting Evidence. A meta-analysis of 32 prospective randomized clinical trials demonstrated the effectiveness of ACE inhibitor therapy for reducing morbidity and mortality in patients with overt heart failure (7). Patients had symptomatic congestive heart failure and were randomly allocated to placebo or ACE inhibitor therapy for at least 8 weeks. Overall, there were 611 deaths among 3870 patients assigned to ACE therapy (15.8%) and 709 deaths among 3235 controls (21.9%). The odds ratio for mortality favoring ACE therapy was 0.77 (95% CI, 0.67 to 0.88). Of note, the largest reduction in mortality was observed within the first 90 days of treatment. The benefits of ACE inhibitors were similar in older and younger patients (odds ratio, 0.79 in patients >80 years of age and 0.71 in patients 60 years of age). One ACE inhibitor survival trial enrolled predominately elderly patients with heart failure (8). The Cooperative North Scandinavian Enalapril Survival Study randomly assigned 253 patients with class IV heart failure (mean age, 71 years) to receive placebo or enalapril. The mortality rate at the end of 6 months was 26% in the enalapril group and 44% in the placebo group, a reduction of 40% (P = 0.002). The mortality rate among enalapril recipients was reduced by 31% at 1 year (P = 0.001). A retrospective cohort study of very old persons (mean age, 85 years) that used the Systematic Assessment of Geriatric Drug Use via Epidemiology study database demonstrated that patients treated with ACE inhibitors had a 10% reduction in mortality rate compared with patients taking digoxin, as well as a lower rate of functional decline (9). The optimal dose of ACE inhibitors is not known. Early studies suggested that patients should take the maximum dose. However, newer studies have reported benefits at lower doses. Furthermore, there may be many reasons for choosing lower doses in older patients (such as hypotension). A single trial in elderly patients with heart failure demonstrated that angiotensin-receptor antagonists were better tolerated and reduced mortality compared with ACE inhibitors. The Evaluation of Losartan in the Elderly study randomly assigned 722 elderly patients with heart failure to receive captopril or the angiotensin-receptor antagonist losartan for 48 weeks (10). Both treatments produced similar changes in renal function, which was the primary outcome of the study. Death from or hospital admission for heart failure occurred in 9.4% of the losartan group and 13.2% of the captopril group (risk reduction, 32% [95% CI, 4% to 55%]; P = 0.075). This reduction was primarily due to a decrease in all-cause mortality (4.8% vs. 8.7%; risk reduction, 46% [CI, 5% to 69%]; P = 0.035). Since the development of this indicator, Evaluation of Losartan in the Elderly Study II has been published (11); no difference in mortality between captopril and losartan was found in elderly patients with heart failure (relative risk, 1.12 [CI, 0.95 to 1.25]; P = 0.16). Because data from clinical trials are limited, angiotensin-receptor antagonists have not been approved for use in heart failure by the U.S. Food and Drug Administration. For the purposes of this quality indicator, angiotensin-receptor antagonists and ACE inhibitors are treated as equivalent. Quality Indicators 3 and 4 Medical History IF a vulnerable elder has newly diagnosed heart failure, THEN a history should be taken at the time of diagnosis and hospitalization to document the presence or absence of previous myocardial infarction; coronary artery disease; revascularization; current symptoms of chest pain or angina; history of hypertension, diabetes, hypercholesterolemia, valvular heart disease, or thyroid disease; smoking status; current medications; and functional capacity (for example, New York Heart Association functional status) BECAUSE ruling out reversible or treatable causes or precipitants of heart failure may improve prognosis. Physical Examination IF a vulnerable elder has newly diagnosed heart failure, THEN the following physical examination findings should be documented at presentation: body weight; blood pressure; heart rate; and results of lung, cardiac, and abdominal or lower-extremity examination BECAUSE these elements are important in the diagnosis of congestion and volume overload and help to guide dosing of diuretics and other medications, which in turn can help to reduce symptoms and the need for rehospitalization. Supporting Evidence. In most patients, congestive heart failure has an identifiable and potentially treatable cause, and elements of the medical history and physical examination are important in elucidating those causes. The literature search did not identify any clinical trial that directly linked any individual item of the medical history or physical examination to better patient outcomes. One observational study related process-of-care measures, including documentation in the medical record of medical history data in patients with heart failure, with reduced 30-day mortality (12). In this study, explicit process criteria and scales for patients hospitalized with heart failure were developed and applied to a nationally representative sample of 14 012 hospitalized Medicare patients. The indicators included physician cognitive process score, including documentation in the medical record of surgical history and a lung examination. The mortality rate at 30 days was 12% among patients with heart failure who received good phy