Study over Heart Failure Management in Europe | Myocardial Infarction | Clinical Trial

European Journal of Heart Failure 2 Ž2000.

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The Euro Heart Failure Survey of The EUROHEART Survey Programme

A survey on the quality of care among patients with heart failure in Europe
J.G.F. Clelanda, , K. Swedbergb, A. Cohen-Solalc, J.Cosin-Aguilard, R. Dietze, F. Follathf , A. Gavazzig, R. Hobbsh , J. Korewickii, H.C. Madeiraj, I. Predak , W.H. van Gilstl , J. Widimskym, V. Mareev n for The Study Group on Diagnosis of the Working Group on Heart Failure of the European Society of Cardiology, J. Masono, N. Freemantleo , Joanne Eastaugh o for The Medicines Evaluation Group Centre for Health Economics University of York
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Kingston upon Hull, UK; b Goteborg, Sweden; c Clichy, France; d Valencia, Spain; e Berlin, Germany; f Zurich, Switzerland; g Bergamo, ¨ ¨ Italy; h Birmingham, UK; i Warsaw, Poland; j Lisbon, Portugal; k Budapest, Hungary; l Groningen, The Netherlands; m Prague, Czech Republic; n Moscow, Russia; o York, UK Accepted 18 April 2000

Abstract Background: The EUROHEART programme is a rolling programme of cardiovascular surveys among the member nations of the European Society of Cardiology ŽESC.. These surveys will provide information on the nature of cardiovascular disease and its management. This manuscript describes a survey into the nature and management of heart failure. Aims: The EuroHeart Failure survey aims to describe the quality of hospital care, diagnostic and therapeutic, for patients with suspected or confirmed heart failure in ESC member countries. Patients will be interviewed subsequent to hospital discharge to assess their understanding of their condition, side effects from and their compliance with therapy and their satisfaction with the management for heart failure. The quality of management will be judged against the recommendations contained in the ESC guidelines on diagnosis and treatment of heart failure. Outcome will be further assessed by repeat interviews in 6 12 months time. A further survey of heart failure in 2001r2002 is also planned. Methods: A prospective survey of all deaths and discharges from medical Žcardiology, internal medicine and geriatric medicine. and cardiac surgical wards to identify patients with heart failure, suspected or confirmed. Approximately 70 hospital clusters, comprising two to six hospitals in each cluster, in 24 member countries of the ESC are conducting the study. At the time of writing, approximately 30 000 deaths and discharges have been screened and approximately 4000 patients have been enrolled. Conclusions: The EuroHeart Survey will allow actual practice to be compared to ESC guidelines on the diagnosis and treatment of heart failure. The surveys and guidelines should prove mutually informative. The main EuroHeart Failure project will be completed by late 2000. However,

Corresponding author. University of Hull, Castle Hill Hospital, Castle Road, Cottingham HU16 5JQ, UK. Tel.: q44-1482-624085; fax: q44-1482-624-085. E-mail address: j.g.cleland@medschool.hull.ac.uk ŽJ.G.F. Cleland.. 1388-9842r00r$20.00 2000 European Society of Cardiology. All rights reserved. PII: S 1 3 8 8 - 9 8 4 2 Ž 0 0 . 0 0 0 8 1 - 7

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new centres volunteering to participate in the study Žcontact corresponding author. may be accepted providing they have the necessary research personnel and provided funding can be agreed for statistical support and administration. 2000 European Society of Cardiology. All rights reserved.
Keywords: Heart failure; Survey; Euroheart

1. Introduction Heart failure is common, disabling, deadly and highly treatable. The European Society of Cardiology, by way first of a Task Force and later a Working Group on Heart Failure has published guidelines for the diagnosis w1x and treatment w2xof heart failure. These guidelines provide standards of care that health care professionals in member nations should strive to achieve or exceed. However, the relatively small number of published reports that exist suggest that heart failure is not well managed w3 8x. These may not be representative of actual practice, either because they were conducted in selected patients groups in expert centres, in which case actual practice may be worse, or, because they were conducted in response to perceived deficiencies in local practice, in which case current practice may be better than the published evidence suggests. Moreover, these reports concentrate on therapy whereas the major deficiency in the delivery of care for heart failure may be inadequate diagnosis. Studies show, and guidelines reinforce, the inadequacy of diagnosis by clinical means alone w1x. Failure to deliver appropriate treatment for heart failure may be a direct result of a lack of adequate diagnosis. Furthermore, there is a paucity of data on patients’ knowledge about heart failure, which may have important repercussions on compliance with appropriate diet and therapy w2x. Hospital is a critical point of care for heart failure because at this time diagnosis and management are likely to be revised. Up to 80% of first-diagnoses of heart failure occur at the time of hospitalisation w9,10x and one-third of patients with heart failure will be hospitalised within any given year w11,12x, reflecting the more severe end of the disease spectrum in terms of morbidity and mortality. Accordingly, it seems appropriate to target such patients for special care and attention. In-hospital mortality is approximately 20% and many patients with heart failure will die or be re-hospitalised Ž10 30% or more. within the following 6 months w11 14x. Hospitalisation accounts for ; 65% of healthcare costs in managing heart failure w15x. Good medical care, based on an accurate diagnosis and appropriate treatment, is effective in reducing mortality and re-admission to hospital. The Euro Heart Failure survey is part of a rolling programme of surveys into different aspects of cardiovascular disease in member countries of the Euro-

pean Society of Cardiology ŽESC.. This survey is designed to assess whether ESC guidelines on the diagnosis and treatment of heart failure are being applied appropriately in patients with heart failure, suspected or confirmed. Furthermore, the survey, through patient interviews, will ascertain how much patients know about heart failure, how it affects their quality of life and whether treatment satisfies their needs. In addition, compliance with lifestyle advice and therapy will be assessed. The programme will also provide a quantitative estimate as well as qualitative description of the hospital disease activity related to heart failure. The criteria for enrolment include a broad spectrum of patients with suspected or confirmed heart failure reflecting the diagnostic as well therapeutic burden of disease. The information gathered will identify deficiencies in care, if they exist, that may be addressed by more effective implementation of current knowledge or development of new treatments. Previous publications suggest that audit of clinical practice by means of such surveys increases implementation of effective therapies. This manuscript describes the aims and methods underlying the programme. The study is hospitalbased. A complimentary study IMPROVEMENTCHF is already being conducted among primary care physicians and their patients in Europe Žunder the auspices of the Study Group on Diagnosis of the Working Group on Heart Failure. w16x.

2. Methods 2.1. Aims The Euro Heart Failure survey has two major purposes. Firstly, through a prospective survey of medical deaths and discharges the survey will describe the quality of hospital care, diagnostic and therapeutic, in ESC member countries for patients with suspected or confirmed heart failure will be described. Secondly, the survey, through patient interviews, will ascertain how much patients know about heart failure, how it affects their quality of life and whether treatment satisfies their needs. In addition, compliance with lifestyle advice and therapy will be assessed. The project should lead to practical recommenda-

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tions on how the quality of care for heart failure can be improved. In addition, the study will provide data on the frequency of admissions with heart failure, the demographic and clinical characteristics of the patients admitted and their short- and long-term outcome. 2.2. Hospital clusters The EuroHeart Failure study is largely based on tertiary-care andror University hospitals because such centres are likely to have the necessary range of cardiology practice and are more likely to be able to identify, support and maintain the dedicated research staff required for the programme. However, such centres are unlikely to represent the totality of hospital practice. Accordingly, hospitals have been organised into clusters. Clusters must consist of at least two hospitals, at least one of which should not have cardiac surgery on site and at least one of which must accept unselected admissions direct from the local community. The great majority of participating hospitals in most countries accepts unselected admissions but in some countries specialist cardiology hospitals that accept only cardiology admissions paired up with general hospitals. At the time of press 70 clusters, including over 150 hospitals, in 24 ESC countries are actively participating Žsee Tables 1 and 2.. A two-page form is completed for each participating hospital to describe its nature Ži.e. University, regional cardiac centre, general community hospital., size Žbeds, cardiology staff, number of procedures. and services including detailed information on cardiac imaging techniques and the quantification of ejection fraction. 2.3. Patient selection All hospitals are asked to carry out an initial survey of all deaths and discharges from wards accepting
Table 1 Countries participating in the EuroHeart Failure Survey ŽApril 2000. a Austria France Israel Portugal Sweden
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general internal medicine admissions, including cardiology, and cardiac surgery wards. If this identifies that there are substantially more than 150 deaths and discharges per week from these wards, the wards are subdivided to make the sample size manageable for a single research officer, unless the local cluster is able to provide more research personnel from their own resources. For example a hospital with 280 relevant deaths and discharges per week could conduct the survey in half the wards for 3 weeks and the second half for another 3 weeks. Each hospital in the cluster is then asked to survey all consecutive deaths and discharges from specified wards continuously for 6 weeks, with the above provision for very busy hospitals. Usually this is done sequentially over two 6-week periods, although some clusters manage to survey more than one hospital concurrently. A simple log of all patients screened is kept and an entry is made for each episode. One patient can be screened several times if they have recurrent events during the 6-week screening period. The screening log is held confidentially at each site and is not transmitted to the data centre but provides a means for the investigator to identify all individual patients screened. A form is completed for each death or discharge screened ŽFig. 1.. Patients who fulfil any one of the four criteria shown in Fig. 1 are enrolled in the study. Many patients fulfil several of the criteria. In addition, all deaths and all episodes that include an acute myocardial infarction, new-onset or paroxysmal atrial fibrillation or diabetes, even if the patient does not fulfil the entry criteria, are identified. A log containing detailed information on how to contact the patient is kept confidentially for all enrolled patients. Each patient is enrolled only once. 2.4. Data collected on enrolled patients This index admission will include both incident

Belgium Germany Italy Russia Switzerland

Czech Republic Greece Lithuania Slovak Republic Turkey

Denmark Hungary Netherlands Slovenia UK

Finland Irish Republic Poland Spain

Discussions regarding centres in Egypt and Ukraine are currently underway.

Table 2 Sponsoring companies as at April 2000 AstraZeneca Medtronic Pfizer Guidant DuPont Orion Pharma Merck F Hoffman-la-Roche Knoll A Bristol-Myers Squibb Merck, Sharpe & Dohme SmithKline Beecham Menarini Parke-Davis Novartis Servier International Sanofi

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Fig. 1.

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Fig. 1.

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Žnew cases diagnosed as heart failure for the first time. and prevalent Žexisting medical cases of heart failure with prior hospital or general practice diagnosis of heart failure. cases. Whether a case is incident or prevalent will be determined from a review of the report form. A large amount of data is collected not only on the current admission but also on up to three previous admissions. Data collected includes the aetiologies and contributing factors for heart failure, reasons for admission, the length of stay, who cares for the patient and where. Information on the investigation of heart failure and its differential diagnoses and for the investigation of concomitant cardiovascular and relevant non-cardiovascular disease is sought. A copy of each enrolled patient’s 12-lead ECG and echocardiographic report, if available, is sent to the co-ordinating centre. Detailed information on non-pharmacological and pharmacological therapy is collected, including the name and doses of all cardiovascular drugs used. It is expected that approximately 10% of patients screened will be enrolled, although early indications suggest this estimate was conservative. 2.5. Inter¨ iews Surviving patients who are willing to attend for interview are given an out-patient appointment 12 weeks after the date of discharge. At this time, information on diagnosis and therapy is updated. Patients are asked about any side effects of therapy that they may have encountered, their compliance with therapy and whether they believe that any particular therapy has helped their condition. Patients are also asked whether they understand what the term ‘heart failure’ means and questions about any lifestyle advice they may have received and whether they follow the advice. The Euro Heart Failure quality of life questionnaire is completed for each patient. A simple physical examination is conducted at the time of interview and a blood sample collected for the later measurement of natriuretic peptides, a potential marker of cardiac dysfunction, in a core laboratory at the co-ordinating centre. Finally, the investigator is asked to rate how likely the diagnosis of heart failure is for each patient interviewed. 2.6. Staff The ESC employs a research officer in the majority of the current EUROHEART sites, while a substantial minority of sites has employed a dedicated member of staff from their own resources. The intention of the ESC is to set up a network of hospital clusters for the conduct of a rolling survey programme of

cardiovascular disease. The heart failure survey will be followed by one on acute coronary syndromes and then one on atrial fibrillation. This will create a professional group of survey staff to collect highquality data. 2.7. Data recording and management Information is recorded on forms with self-duplicating paper in this survey. The intact top copy is returned to the data centre at the Medicines Evaluation Group at the University of York ŽUK., the duplicate copy is torn out and retained at the investigator site. Centres and patients are only identified by a code number. Only the investigator can trace the code number to an individual patient. Data will be published from the whole data set, from European regions and from individual countries where three or more hospitals have participated. If there are two or less hospitals from a country then the national data will be incorporated into a regional data-set unless otherwise requested. Individual hospital data will be provided only to that hospital and will not be published other than at the express wish of the investigator. Future surveys will probably be conducted using an electronic case report form. 2.8. Long-term follow-up Patients will be asked to attend for further interview during 2001 at which time their symptoms and quality of life and any intercurrent morbidity will be re-assessed. The survival status and any hospitalisations of patients who fail to attend will be ascertained.

3. Discussion Current knowledge of the epidemiology of heart failure has been recently comprehensively summarised w17,18x. It is one of the most common reasons for hospital admission, incurs a high morbidity and mortality and consumes substantial healthcare resources w13,15,19,20x. Despite improvements in the treatment of hypertension and myocardial infarction, admission rates for heart failure continue to rise w12,21x. The reasons for this increase are multi-factorial with increasing age probably an over-riding factor. However, admissions for heart failure in patients below the age of 65 years also appear to be increasing w12x possibly reflecting improved postinfarction care, which has its greatest impact on the prognosis of patients destined to develop heart failure. The Euro Heart Failure study will provide valuable information on how heart failure presents and is

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managed, diagnostically as well as therapeutically, and will allow comparisons among member countries of the ESC. Unlike commercial surveys of clinical practice, the results will be placed in the public domain allowing the information to be used by clinicians, health services and government, to target deficiencies, should any exist, in the current clinical care of patients with heart failure. The survey has been deliberately designed to enrol patients in whom a diagnosis of heart failure is uncertain as well as those with confirmed heart failure, as only by doing so can the adequacy of clinical diagnosis be assessed. The sample will also include patients in whom a diagnosis of heart failure has been suspected but refuted. This is part of the clinical burden of heart failure. A variety of case definitions of heart failure have been created for epidemiological studies. The sensitivity and specificity of such definitions have not been adequately tested against a standard clinical diagnosis nor are they frequently used in clinical practice w22x. It is clear that case definitions depend upon clinical variables that are subject to large inter-observer variability and a low specificity andror sensitivity for a diagnosis of heart failure w1x. The EuroHeart Failure Survey captures sufficient information not only to document the supporting evidence for the clinician’s diagnosis but also to apply the standard, but potentially flawed, case-definitions frequently used in epidemiological studies. Furthermore, it is hoped that the measurement of natriuretic peptides in a large proportion of this population will provide some objective evidence of cardiac dysfunction w23 25x. Plasma concentrations of these peptides will be interpreted in the light of serum urea and creatinine measurements. There was considerable debate within the study group on whether the study should be conducted in a retrospective or prospective fashion. A retrospective study, identifying patients with a diagnosis of heart failure at death or discharge within the last 6 months as recorded by the hospital administrative system was considered. Such a study design would have had the advantage of not altering clinical practice. However, many hospitals in the study did not have an electronic record system that would allow patients with a discharge diagnosis of heart failure to be identified easily. Moreover, such a design would miss large numbers of patients in whom heart failure might be suspected but not yet confirmed or recorded in the case notes, a group of major interest to this study. A truly prospective study looking at admissions with heart failure would miss the large number of patients who develop heart failure subsequent to admission. Reviewing all patients continuously for the development of evidence of heart failure during their hospital stay would not only be very time consuming but also would

be likely to alter clinical management. The current study design interfered minimally with usual clinical care, identified patients with suspected as well as confirmed heart failure, included patients developing heart failure subsequent to admission, while requiring only one assessment. Accordingly, this study design seemed most efficient. The EuroHeart Failure survey will underestimate the true hospital burden of heart failure. The study cannot guarantee 100% ascertainment of deaths and discharges with heart failure, as general surgical wards and some medical speciality wards not engaged in caring for acute medical admissions were not surveyed. Studies of general surgical patients suggests a relatively high prevalence of heart failure in this population, 14% in one survey of mainly elective, non-cardiovascular surgical admissions patients aged ) 65 years w26x. However, the survey will provide complimentary information to that provided by national statistical data reporting hospital disease activity related to heart failure provided by several countries. Because approximately 80% of first-diagnoses of heart failure are made in hospital w9,10x, the survey will also provide an estimate of the incidence of heart failure. Synthesis of the data from this survey with that from epidemiological studies on the incidence and prevalence of heart failure and national hospital discharge statistics should allow a more accurate picture of the true clinical activity related to heart failure in Europe. It will also provide information on who looks after patients with heart failure in hospital and the cost entailed in their management. This survey will be an extremely powerful health economic resource. This study will provide, for the first time, information on how a diagnosis of heart failure is approached in clinical practice. Of particular interest will be how often the left ventricular ejection fraction is recorded and how often coronary arteriography is performed. The study population is not restricted to the entry criteria usually required in a clinical trial and information on investigations performed for the differential diagnosis of heart failure from respiratory and other diseases will be unique. Diagnostic uncertainty may be one of the most important reasons for under-treatment. Optimal management of heart failure requires investigation to confirm the presence and nature of cardiac dysfunction and to exclude alternative diagnoses w1x. Single centre studies show that a community diagnosis of heart failure by clinical means alone appears wrong in approximately 50% of cases w9,27 29x. The diagnostic uncertainty of a hospital diagnosis has not been adequately explored. Although a hospital diagnosis of heart failure by clinical means alone may be more accurate than in the community, this is a supposition.

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It is clear that echocardiography is not performed routinely for patients with suspected heart failure in some hospitals w4,9x. European guidelines for the diagnosis of heart failure have suggested a minimum data set of investigations including echocardiography to confirm cardiac dysfunction, biochemistry and haematology to exclude major renal dysfunction and anaemia and a chest X-ray to exclude pulmonary pathology w1x. In addition, a normal ECG was considered useful in excluding the diagnosis. Without adequate diagnosis appropriate therapy cannot be selected. Diagnosis in heart failure goes beyond merely establishing the presence of heart failure. It is also important to establish the underlying cause of heart failure. Currently, the optimal treatment of ‘diastolic’ heart failure is unknown. Only heart failure due to left ventricular systolic dysfunction has been adequately studied in clinical trials and only these patients are known to respond to ACE inhibitors, beta-blockers and spironolactone. Differentiation of systolic from diastolic heart failure or estimation of the severity of systolic dysfunction by clinical means alone is generally poor w30,31x. The presence of left ventricular systolic dysfunction can currently only reliably be determined by imaging. New interventions for heart failure may be best directed at previously poorly characterised subsets of patients such as those with atrial fibrillation, diabetes or intra-ventricular conduction defects. This study will gain added value by quantifying these aspects of heart failure across Europe. Most previous studies have accepted ‘best guess’ diagnosis for the diagnosis of conditions such as dilated cardiomyopathy, leading to an under-diagnosis of ischaemic heart disease w32x. Some studies have attempted to quantify diagnostic uncertainty w33x. While a ‘working diagnosis’ is often a necessary part of patient management it is also important, in the context of epidemiological studies and clinical trials, to quantify diagnostic uncertainty. The EuroHeart Failure survey has been designed to capture the evidence on which the aetiological diagnosis of heart failure is made. European guidelines indicate that patients with heart failure secondary to left ventricular systolic dysfunction should be treated with ACE inhibitors to improve symptoms, and reduce progressive worsening of heart failure, recurrent hospitalisation and mortality w2x. Despite this evidence it would appear, from studies conducted in a number of individual centres, that only a minority of patients with heart failure are treated with ACE inhibitors w4 9x. It is not clear to what extent the apparent under-use of ACE inhibitors is due appropriate withholding of treatment in patients with heart failure associated with normal systolic dys-

function and what proportion of patients have a relative or absolute contra-indication to ACE inhibitor use w3x. Therefore, the therapeutic shortfall with ACE inhibitors could be related primarily to a lack of adequate diagnosis. European guidelines also recommend the use of spironolactone in patients with advanced heart failure, a recommendation subsequently supported by a large clinical trial that showed a reduction in mortality and morbidity with spironolactone compared to placebo w34x. Many of the patients in this survey will have been admitted for acute decompensation of heart failure and would potentially be eligible for such treatment. European guidelines currently recommend beta-blockers only for mildto-moderate heart failure, although recent studies have suggested a benefit even in severe heart failure. However, as beta-blockers are still relatively contraindicated soon after a period of acute decompensation a relatively low uptake is expected at the time of initial discharge. However, a large number of patients should have been initiated on a beta-blocker by the 12-week interview if the appropriate follow-up care is in place. Information on the use of treatments with specific indications, such as warfarin, and of contraindicated therapy is also collected. The survey will also assess the frequency of discontinuation of therapy and whether it is titrated appropriately after discharge. Thus, this survey will give valuable insights into the rapidity and appropriateness of uptake of effective treatments for heart failure. Even after a correct diagnosis and appropriate treatment, patients may still fail to benefit because they do not take treatment as directed. Little information on patients’ compliance with heart failure therapy exists. The data that do exist suggest that compliance may be very poor indeed; only 10% in one recent study of digoxin w35x. Failure to comply with therapy could be responsible for a substantial proportion of hospital admissions for heart failure. Although it is generally recommended that patients with heart failure restrict their salt intake it is not clear whether this information is given to patients w2x. Better patient education could improve their understanding of disease, improve compliance with treatment Žas well as salt, alcohol and tobacco consumption. and, therefore, reduce morbidity and improve survival. Finally, the study will show if effective treatment has controlled patients symptoms adequately and to what extent their quality of life remains impaired. There is a view held by some people that with four classes of agents Ždiuretics, ACE inhibitors, betablockers and aldosterone antagonists, digoxin possibly being a fifth. available for managing heart failure that there is little room for improvement. This is almost certainly not true. What is remarkable is how few

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proven, effective treatments for heart failure exist and, possibly, how seldom they are deployed. 3.1. Expected ¨ alue of results This will be the first international survey of heart failure based on a representative sample of hospital centres and patients. This survey will determine the quality of care in terms of investigation and therapy, patients understanding of their condition, their satisfaction with care and their compliance with therapy. The results of this survey will, therefore, inform all physicians who look after patients with heart failure about current management in member nations of the European Society of Cardiology and lead to practical recommendations on how the quality of care could be improved.

Acknowledgements The authors would like to acknowledge the dedication of Trish Rawnsley, Sarah Ford and Angela Baksh and the staff of the European Society of Cardiology ŽRenaud Longelin, Malika Manini and Anne Dissing. who have worked hard to administer and pilot the survey. We also recognise the support and assistance of Mr Colm Bradley and CBC Oxford, which was crucial for the planning and organisation of this survey. The survey could not have been conducted without the generous sponsorship of the companies shown in Table 2. References
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J.G.F. Cleland et al. r European Journal of Heart Failure 2 (2000) 123 132 chronic heart failure in the community. Q J Med 1993; 86:17 23. Remes J, Miettinen H, Reunanen A, Pyorala K. Validity of clinical diagnosis of heart failure in primary health care. Eur Heart J 1991;12:315 321. Remes J, Lansimies E, Pyorala K. Usefulness of M-mode echocardiography in the diagnosis of heart failure. Cardiology 1991;78:267 277. Andersson B, Caidahl K, Waagstein F. Chest 1995. Ghali JK, Kadakia S, Cooper RS, Liao YL. Am J Cardiol 1991. Brookes CIO, Hart P, Keogh BE, Cleland JGF. Angiography and the aetiology of heart failure. Postgrad Med J 1995; 71:480 482. w33x Sutton GC. Epidemiologic aspects of heart failure. Am Heart J 1990;120:1538 1540. w34x Pitt B, Zannad F, Remme WJ, Cody R, Castaigne A, Perez A. The effect of spironolactone on morbidity and mortality in patients with severe heart failure. N Engl J Med 1999; 341:709 717. w35x Monane M, Bohn RL, Gurwitz JH, Glynn RJ, Avorn J et al. Noncompliance with congestive heart failure therapy in the elderly. Arch Intern Med 1994;154:433 437.

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