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B M Massie

Publications and source records attributed to B M Massie.

At least 19 recordsLinked to original sources

Toleration of high doses of angiotensin-converting enzyme inhibitors in patients with chronic heart failure: results from the ATLAS trial. The Assessment of Treatment with Lisinopril and Survival.

BACKGROUND: Treatment with angiotensin-converting enzyme (ACE) inhibitors reduces mortality and morbidity in patients with chronic heart failure (CHF), but most affected patients are not receiving these agents or are being treated with doses lower than those found to be efficacious in trials, primarily because of concerns about the safety and tolerability of these agents, especially at the recommended doses. The present study examines the safety and tolerability of high- compared with low-dose lisinopril in CHF. METHODS: The Assessment of Lisinopril and Survival study was a multicenter, randomized, double-blind trial in which patients with or without previous ACE inhibitor treatment were stabilized receiving medium-dose lisinopril (12.5 or 15.0 mg once daily [OD]) for 2 to 4 weeks and then randomized to high- (35.0 or 32.5 mg OD) or low-dose (5.0 or 2.5 mg OD) groups. Patients with New York Heart Association classes II to IV CHF and left ventricular ejection fractions of no greater than 0.30 (n = 3164) were randomized and followed up for a median of 46 months. We examined the occurrence of adverse events and the need for discontinuation and dose reduction during treatment, with a focus on hypotension and renal dysfunction. RESULTS: Of 405 patients not previously receiving an ACE inhibitor, doses in only 4.2% could not be titrated to the medium doses required for randomization because of symptoms possibly related to hypotension (2.0%) or because of renal dysfunction or hyperkalemia (2.3%). Doses in more than 90% of randomized patients in the high- and low-dose groups were titrated to their assigned target, and the mean doses of blinded medication in both groups remained similar throughout the study. Withdrawals occurred in 27.1% of the high- and 30.7% of the low-dose groups. Subgroups presumed to be at higher risk for ACE inhibitor intolerance (blood pressure, <120 mm Hg; creatinine, > or =132.6 micromol/L [> or =1.5 mg/dL]; age, > or =70 years; and patients with diabetes) generally tolerated the high-dose strategy. CONCLUSIONS: These findings demonstrate that ACE inhibitor therapy in most patients with CHF can be successfully titrated to and maintained at high doses, and that more aggressive use of these agents is warranted.

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Congestive heart failure with preserved systolic function in a statewide sample of community hospitals.

BACKGROUND: The importance of congestive heart failure (CHF) in patients with preserved left ventricular systolic function is increasingly recognized, but most studies have been conducted at a single, usually academic, medical center. The aim of this study was to determine the prognosis, readmission rate, and effect of ACE inhibitor therapy in a Medicare cohort with CHF and preserved systolic function. METHODS AND RESULTS: We examined a statewide, random sample of 1,720 California Medicare patients hospitalized with an ICD-9 diagnosis of CHF confirmed by a decreased left ventricular ejection fraction (EF) or chest radiograph from July 1993 to June 1994 and January 1996 to June 1996. Among the 782 patients with confirmed CHF and an in-hospital left ventricular EF measurement, 45% had reduced systolic function (ReSF) (EF < 40%) and 55% had preserved systolic function (PrSF) (EF > 40%). The PrSF group had a lower 1-year mortality rate but similar hospital readmission rates for both CHF and all causes. In patients with ReSF, ACE inhibitor treatment was associated with a lower mortality rate (P =.04) and a trend toward a lower CHF readmission rate (P =.13). In contrast, ACE inhibition therapy was associated with neither a lower rate of mortality nor CHF readmission in PrSF patients (P =.61 and.12, respectively). In multivariate analyses treatment with ACE inhibitors in PrSF patients was not associated with either a reduction in mortality (hazard ratio, 1.15; 95% CI, 0.79-1.67) or CHF readmission (hazard ratio, 1.21; 95% CI, 0.92-1.58). CONCLUSIONS: CHF with PrSF seems to be associated with high mortality and morbidity rates, but ACE inhibitors may not produce comparable benefit in this group as in patients with ReSF.

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Are we inhibited? Renal insufficiency should not preclude the use of ACE inhibitors for patients with myocardial infarction and depressed left ventricular function.

CONTEXT: Angiotensin-converting enzyme (ACE) inhibitors have been shown to decrease mortality in patients with myocardial infarction and depressed left ventricular function, but physicians may be reluctant to prescribe ACE inhibitors to patients with concomitant renal insufficiency. OBJECTIVE: To evaluate whether patients with depressed left ventricular ejection fraction following acute myocardial infarction have a similar reduction in mortality from ACE inhibitors regardless of their renal function. DESIGN: Retrospective cohort study using medical record data. SETTING: All nonfederal acute care hospitals. PATIENTS: A cohort of 20,902 Medicare beneficiaries aged 65 years and older directly admitted to the hospital from February 1, 1994, through July 30, 1995, and with a documented left ventricular ejection fraction of less than 40% measured by echocardiography, radionuclide scintigraphy, or angiography following a confirmed acute myocardial infarction. MAIN OUTCOME MEASURES: One-year survival for patients who received or who did not receive an ACE inhibitor at hospital discharge, stratified by the patient's level of renal function. RESULTS: For the entire cohort, the receipt of an ACE inhibitor on hospital discharge was associated with greater 1-year survival (hazards ratio, 0.84; 95% confidence interval, 0.77-0.91) after adjusting for patient demographic characteristics, comorbidity, severity of illness (including left ventricular ejection fraction), and the receipt of other therapies. In stratified models, the receipt of an ACE inhibitor was associated with a 37% (16%-52%) lower mortality for patients who had poor renal function (serum creatinine level,<265 micromol/L [<3 mg/dL]) and a 16% (8%-23%) lower mortality for patients who had better renal function. Use of aspirin therapy attenuated the benefit of ACE inhibitors in patients with poor renal function. CONCLUSIONS: Moderate renal insufficiency should not be considered a contraindication to the use of ACE inhibitors in patients with depressed left ventricular ejection fraction following myocardial infarction. Use of aspirin therapy may attenuate the benefit of ACE inhibitors in patients with high serum creatinine levels; therefore, further studies are needed to determine whether treatment with aspirin, alternative antiplatelet agents, or anticoagulation is indicated for these patients.

Aged↗

Acute coronary findings at autopsy in heart failure patients with sudden death: results from the assessment of treatment with lisinopril and survival (ATLAS) trial.

BACKGROUND: Sudden unexpected death frequently occurs in chronic heart failure. The importance of acute coronary events in triggering sudden death (SD) is unclear. METHODS AND RESULTS: We evaluated at autopsy the prevalence of acute coronary findings (coronary thrombus, ruptured plaque, or myocardial infarction [MI]) and their relation to SD. Autopsy results in 171 patients in the randomized ATLAS trial were reviewed. The prevalence of acute coronary findings was 33%: in 54% of patients with significant coronary artery disease (CAD) who died suddenly, 32% who died of myocardial failure, but in non-CAD patients, they were present in only 5% and 10% respectively. The percentage of patients classified as dying of MI was 28% in the autopsy group versus 4% in the nonautopsied group (P<0.0001). Of the autopsied group with acute MI, 97% (31 of 32 patients) with SD and 40% (6 of 15 patients) with myocardial failure did not have the MI diagnosed during life. When undiagnosed MI was classified as "sudden unexpected" or "myocardial failure" from clinical information only, the distribution of death causes was similar in the autopsy and nonautopsied groups. CONCLUSIONS: Acute coronary findings are frequent and usually not clinically diagnosed in heart failure patients with CAD, particularly in those dying suddenly, suggesting the importance of acute coronary events as a trigger for SD in this setting.

Acute Disease↗

A systematic review of the effects of physician specialty on the treatment of coronary disease and heart failure in the United States.

PURPOSE: To assess the effects of physician specialty on the knowledge, management, and outcomes of patients with coronary disease or heart failure. MATERIALS AND METHODS: We performed a systematic search of MEDLINE from 1980 to 1997, as well as bibliographic references to articles about the effects of physician specialty on the knowledge, treatment, and outcomes of patients with coronary disease or heart failure in the United States. RESULTS: Twenty-four articles met our criteria for inclusion (including eight that involved knowledge or self-reported practices, 14 that described actual practice patterns, and six that measured clinical outcomes). Cardiologists were more knowledgeable than generalist physicians about the optimal evaluation and management of coronary disease but not about the use of angiotensin-converting enzyme (ACE) inhibitors for heart failure. Patients with unstable angina or myocardial infarction were more likely to receive proven medical therapies, and possibly had improved outcomes, if they were treated by cardiologists. The use of lipid-lowering drugs after myocardial infarction was also more common among patients of cardiologists. ACE inhibitor use for heart failure was probably greater, and short-term readmission rates were lower, with cardiology care. CONCLUSIONS: Patients with coronary disease or heart failure in the United States who are treated by cardiologists appear more likely to receive evidence-based care and probably have better outcomes. Investigation of collaborative models of care and innovative efforts to improve the use of proven therapies by physicians are needed.

Cardiology↗

Low doses vs. high doses of the angiotensin converting-enzyme inhibitor lisinopril in chronic heart failure: a cost-effectiveness analysis based on the Assessment of Treatment with Lisinopril and Survival (ATLAS) study. The ATLAS Study Group.

OBJECTIVE: A cost-effectiveness analysis of high and low doses of the angiotensin-converting enzyme (ACE) inhibitor lisinopril in the treatment of chronic heart failure. METHODS: A cost-effectiveness analysis using data from a randomized controlled trial, ATLAS, where 3164 patients with chronic heart failure were allocated to a high-dose (daily target dose 32.5-35 mg) or low-dose strategy (daily target dose 2.5-5.0 mg) of lisinopril. Differential costs were based on resource use data collected in the trial costed using UK unit costs. Cost-effectiveness analysis related differential costs to differential life-years during a 4-year trial follow-up. RESULTS: The mean total number of hospital in-patient days per patient was 18. 5 in the high dose group and 22.5 in the low dose group. Over the whole duration of the trial, the mean (S.D.) daily dose of lisinopril in the high-dose group was 22.5 mg (15.7 mg) compared to 3.2 mg (2.5 mg) in the low-dose group. The mean difference in cost per patient was pound sterling 397 lower in the high-dose group [95% CI (high-dose-low-dose) - pound sterling 1263 to pound sterling 436]. Mean life-years per patient were 0.085 years higher in the high-dose group [95% CI (high-dose-low-dose) -0.0074 to 0.1706). Based on mean costs and life-years, high-dose therapy dominates low-dose (less costly and more effective). Allowing for uncertainty in mean costs and life-years, the probability of high-dose therapy being less costly than low dose was 82%. If a decision maker is willing to pay at least pound sterling 3600 per life-year gained, the probability of high-dose being more cost-effective was 92%. CONCLUSIONS: The ATLAS Study showed that the treatment of heart failure with high-doses of lisinopril has a high probability of being more cost-effective than low-dose therapy.

Angiotensin-Converting Enzyme Inhibitors↗

Efficacy and safety of high-dose lisinopril in chronic heart failure patients at high cardiovascular risk, including those with diabetes mellitus. Results from the ATLAS trial.

AIMS: An analysis was designed to determine whether chronic heart failure patients at high cardiovascular risk benefited to the same extent from high-dose lisinopril as the whole ATLAS population. METHODS AND RESULTS: A retrospective analysis was performed on high-risk heart failure patients in the Assessment of Treatment with Lisinopril And Survival (ATLAS) trial (total number of patients 3164) comparing highdose (32.5-35 mg. day(-1)) vs low-dose (2.5-5 mg. day(-1)) lisinopril for a median of 46 months. These high-risk patients included those with hypotension, hyponatraemia, compromised renal function, the elderly and patients with diabetes mellitus at baseline. In the whole study population, high-dose lisinopril led to a trend in risk reduction of all-cause mortality (primary end-point P=0.128) and a significant risk reduction in all-cause mortality plus hospitalization (principal secondary end-point P=0.002). Subgroup analyses were performed for these end-points. There were no consistent interactions between age, baseline sodium, creatinine or potassium values, and treatment effect. Diabetics showed a beneficial response to high-dose therapy that was at least as good as that in non-diabetics. The underlying higher morbidity/mortality rates in diabetics mean that high-dose lisinopril has potential for a larger absolute clinical impact in these patients. CONCLUSION: Long-term high-dose lisinopril was as effective and well-tolerated in high-risk patients, including those with diabetes mellitus, as for the ATLAS study population as a whole.

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Rationale, design, and methods for a Coreg (carvedilol) Heart Failure Registry (COHERE). COHERE Participant Physicians.

BACKGROUND: The success of beta-blocking agents in clinical trials of heart failure (HF) has led to a widespread call for their increased use, which assumes these agents will perform as well in the usual care setting. Given the traditional contraindication of the use of beta-blocking agents in HF, and their perception as difficult to use in HF, observing how they perform in the usual care setting could be critical in accelerating their widespread application. Carvedilol is the only beta-blocking agent currently approved in the United States for use in HF. METHODS: The Coreg (brand of carvedilol; SmithKline Beecham Pharmaceuticals, Philadelphia, PA) Heart Failure Registry (COHERE) is intended to collect data on outcomes and other clinical variables in a typical HF population and to observe experience with carvedilol in the hands of community practitioners. COHERE does not include any specific patient selection or exclusion criteria. The decision to use carvedilol is entirely at the discretion of the participant physician, based on evidence of HF as judged by assessments the practitioner usually uses. All patients will be followed for 1 year, with information on outcomes and other clinical variables collected and analyzed at baseline, the end of titration, and at 6 and 12 months after reaching the maximum tolerated dose. About 600 participant physicians selected to be as representative as possible of the community practice setting will enroll approximately 6,000 patients. CONCLUSIONS: COHERE will be the first and largest prospective observational experience with a new treatment, ie, carvedilol, in patients with HF managed in the usual care setting and should provide valuable information about this new treatment in this environment compared with the more rigid clinical trials setting.

Adrenergic beta-Antagonists↗

Veterans Affairs Quality Enhancement Research Initiative in chronic heart failure.

Chronic heart failure (CHF) is a highly prevalent condition associated with serious morbidity, intense levels of health services use, and shortened survival. It is also a condition for which ameliorative therapies exist. The evidence indicates that there is substantial need to change clinical practice and health care delivery for people with CHF and thereby improve their outcomes. The goal of the Veterans Affairs (VA) Quality Enhancement Research Initiative in CHF (CHF QUERI) is to create measurable, rapid, and sustainable improvements in quality of care and health outcomes of veterans with heart failure. This article describes the current state of knowledge and practice in care for people with CHF. Using the framework of the 5 steps of the QUERI process, we point out the gaps in research and practice that must be filled if the CHF QUERI is to achieve its goal. We relate our recommendations for how the VA can put its research and administrative infrastructure to work to fill the gaps. Lessons learned about CHF in the course of the CHF QUERI will be applicable to all people with heart failure and to all health care systems--VA as well as non-VA--that care for them.

Benchmarking↗

The role of beta-blockers in preventing sudden death in heart failure.

Sudden death accounts for one third to one half of the deaths in patients with heart failure. Recent studies using beta-adrenergic blockers in patients with reduced systolic function and heart failure symptoms have shown significant reductions in overall mortality rates. This article discusses the role of beta-blockers in preventing sudden death in these patients. Six large beta-blocker trials in patients with heart failure have been published to date, with a combined relative risk reduction for sudden death of 38% (confidence interval [CI] 0.53-0.23; P < .001). Although dependent on a nonmechanistic definition of sudden death, the clinical trials of beta-blockers to date have shown that they significantly reduce the risk of sudden death in patients with heart failure. Future studies are required to define the role of other heart failure therapies in the context of this new standard of care.

Adrenergic beta-Antagonists↗

Comparative effects of low and high doses of the angiotensin-converting enzyme inhibitor, lisinopril, on morbidity and mortality in chronic heart failure. ATLAS Study Group.

BACKGROUND: Angiotensin-converting enzyme (ACE) inhibitors are generally prescribed by physicians in doses lower than the large doses that have been shown to reduce morbidity and mortality in patients with heart failure. It is unclear, however, if low doses and high doses of ACE inhibitors have similar benefits. METHODS AND RESULTS: We randomly assigned 3164 patients with New York Heart Association class II to IV heart failure and an ejection fraction < or = 30% to double-blind treatment with either low doses (2.5 to 5.0 mg daily, n=1596) or high doses (32.5 to 35 mg daily, n=1568) of the ACE inhibitor, lisinopril, for 39 to 58 months, while background therapy for heart failure was continued. When compared with the low-dose group, patients in the high-dose group had a nonsignificant 8% lower risk of death (P=0.128) but a significant 12% lower risk of death or hospitalization for any reason (P=0.002) and 24% fewer hospitalizations for heart failure (P=0.002). Dizziness and renal insufficiency was observed more frequently in the high-dose group, but the 2 groups were similar in the number of patients requiring discontinuation of the study medication. Conclusions-These findings indicate that patients with heart failure should not generally be maintained on very low doses of an ACE inhibitor (unless these are the only doses that can be tolerated) and suggest that the difference in efficacy between intermediate and high doses of an ACE inhibitor (if any) is likely to be very small.

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Beta-adrenergic blocker mortality trials in congestive heart failure.

Many of the current discussions of beta-adrenergic blocker therapy in patients with congestive heart failure have used fairy tales to describe the evolution of this treatment from contraindication to standard of care. This article reviews the early studies that initiated this revolution in heart failure therapy and discusses the major mortality trials that have demonstrated that these agents improve survival and limit the progression of congestive heart failure. These major trials have used 1 of 4 beta blockers (metoprolol, bisoprolol, carvedilol, or bucindolol) in varying study designs with different patient populations. Each trial had different objectives and limitations, and these are described in the context of their impact on proving a survival benefit. In addition, the specific effect of beta-blocker therapy on sudden death in patients with heart failure is briefly discussed. The weight of these trials suggests that beta-adrenergic blocker therapy can save 1 life of every 35 patients treated in patients with mild-to-moderate heart failure. The data are compelling and the techniques for "starting low and going slow" with titrations have been well documented.

Adrenergic beta-Antagonists↗

Outcome following acute myocardial infarction: are differences among physician specialties the result of quality of care or case mix?

BACKGROUND: Studies to determine whether care by cardiologists improves the survival of patients with acute myocardial infarction (MI) have produced conflicting results, and it is not known what accounts for differences in patient outcome by physician specialty. OBJECTIVES: To evaluate whether cardiologists provide more recommended therapies to elderly patients with acute MI and, if so, to determine whether variations in processes of care account for differences in patient outcome. DESIGN: Retrospective cohort study using medical chart data and administrative data files. SETTING: All nonfederal acute care hospitals in California. PATIENTS: A cohort of 7663 Medicare beneficiaries 65 years and older directly admitted to the hospital with a confirmed acute MI from April 1994 to July 1995 with complete data regarding potential contraindications to recommended therapies. MAIN OUTCOME MEASURES: Percentage of "good" and "ideal" candidates for a given acute MI therapy who actually received that therapy, percentage who received exercise stress testing or coronary angiography, percentage who underwent revascularization, and 1-year mortality, stratified by specialty of the attending physician. RESULTS: During hospitalization, good candidates for aspirin were more likely to receive aspirin if they were treated by cardiologists (87%) than by medical subspecialists (73%; P<.001), general internists (84%; P = .003), or family practitioners (81%; P<.001). Cardiologists were also more likely to treat good candidates with thrombolytic therapy (51%) than were medical subspecialists (29%; P<.001), general internists (40%; P<.001), or family practitioners (27%; P<.001). Patients of cardiologists were 2- to 4-fold more likely to undergo a revascularization procedure. Despite these differences in utilization, we found similar 30-day mortality rates across physician specialties. However, 1-year mortality rates were greater for patients treated by medical subspecialists (odds ratio [OR], 1.9; 95% confidence interval [CI], 1.6-2.3), general internists (OR, 1.4; 95% CI, 1.3-1.6), and family practitioners (OR, 1.7; 95% CI, 1.4-1.9) than for those treated by cardiologists. Adjusting for differences in patient and hospital characteristics markedly reduced the ORs for those treated by medical subspecialists (OR, 1.2; 95% CI, 0.9-1.4), general internists (OR, 1.1; 95% CI, 1.0-1.3), and family practitioners (OR, 1.3; 95% CI, 1.1-1.6), whereas further adjustment for medication use and revascularization procedures had little effect. CONCLUSIONS: Differences in the use of recommended therapies by physician specialty are generally small and do not explain differences in patient outcome. In comparison, differences among patients treated by physicians of various specialties (case mix) have a large impact on patient outcome and may account for the residual survival advantage of patients treated by cardiologists. With the exception of the in-hospital use of aspirin, recommended MI therapies are markedly underused, regardless of the specialty of the physician.

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Variations in family physicians' and cardiologists' care for patients with heart failure.

BACKGROUND: Improved understanding of the reasons for underuse of diagnostic tests and treatments for congestive heart failure (CHF) may be helpful for designing future interventions to improve quality of care. METHODS: To determine differences between family physicians' and cardiologists' practice styles for diagnosis and treatment of CHF, a random sample of family physicians and cardiologists were surveyed with standardized case scenarios. RESULTS: Survey respondents were 182 family physicians and 163 cardiologists. Family physicians were less likely than cardiologists to rate measurement of left ventricular ejection fraction as "very important" for patients with new CHF, less likely to order an echocardiogram or test for ischemia, and much less likely to identify diastolic dysfunction as a cause of CHF. Family physicians were more likely to prescribe digoxin when it was not indicated (diastolic dysfunction) and less likely to prescribe digoxin and an angiotensin-converting enzyme (ACE) inhibitor when they were indicated (moderately to severely reduced left ventricular ejection fraction). Family physicians expressed more concern over the risks of ACE inhibitors in patients with blood pressure of 100/70 mm Hg or serum creatinine of 2.0 mg/dL and were less likely to prescribe an ACE inhibitor in these settings. Family physicians overestimated the risks of warfarin use for atrial fibrillation and were therefore less likely to prescribe warfarin. CONCLUSIONS: Family physicians appear to have less understanding of CHF pathophysiology (ie, systolic versus diastolic dysfunction) and how treatment differs according to the underlying disease process. Overestimation of the risk of ACE inhibitor and warfarin use may result in underprescribing these medications.

Angiotensin-Converting Enzyme Inhibitors↗

A randomized trial of ecadotril versus placebo in patients with mild to moderate heart failure: the U.S. ecadotril pilot safety study.

OBJECTIVE: To determine the short-term safety and tolerability of the addition of ecadotril to conventional therapy in patients with mild to moderate heart failure. METHODS: Fifty ambulatory patients, 18 to 75 years of age, with mild to moderate heart failure, left ventricular ejection fraction </=35%, taking stable doses of angiotensin-converting enzyme inhibitor, diuretics, and optionally digoxin were enrolled in a randomized, double-blind, placebo-controlled dose-escalation study of ecadotril 50 to 400 mg twice daily versus conventional therapy alone. RESULTS: No increases in deaths, serious adverse events, or dropouts from adverse events were observed for the ecadotril group compared with placebo. The serum measures of neurohormonal activation were highly variable. Changes in signs and symptoms of heart failure, New York Heart Association class, and patient self-assessment of symptoms were not observed with ecadotril therapy; however, the study was not designed to detect differences in these parameters. CONCLUSION: In this small pilot study, ecadotril in doses of 50 to 400 mg twice daily was generally well-tolerated and without severe short-term adverse effects in patients with mild to moderate heart failure. Evaluation of the clinical efficacy and long-term safety of ecadotril and other neutral endopeptidase inhibitors in patients with heart failure requires further study.

Adolescent↗

Effect of a home monitoring system on hospitalization and resource use for patients with heart failure.

BACKGROUND: Heart failure has a large medical and economic impact on the elderly. Past studies have shown that high-intensity multidisciplinary interventions at academic medical centers can reduce future hospitalizations. Our pilot study examined the effects of a low-intensity monitoring program on hospitalizations and cost of care for patients with heart failure treated by community physicians. METHODS: We enrolled 68 patients with heart failure (mean age 73 +/- 13 years, 53% male) monitored by 31 physicians in a multidisciplinary program of patient education, daily self-monitoring, and physician notification of abnormal weight gain, vital signs, and symptoms. Comparisons of medical claims were made between the patients who received the intervention and a control group of 86 patients matched to the intervention group on medical claims during the preceding year. RESULTS: Compared with the prior year, medical claims per year decreased in the intervention group ($8500 +/- $13,000 to $7400 +/- $11,400), whereas they increased in the control group ($9200 +/- $15,000 to $18,800 +/- $34,000, P <.05). Similar differences were observed for hospitalizations and total hospital days. The program's effectiveness was unrelated to age, sex, or type of left ventricular dysfunction. CONCLUSIONS: These findings suggest that a multidisciplinary program of patient education, monitoring, and physician notification can reduce resource use in patients with heart failure managed in a community setting.

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