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European Journal of Heart Failure 2004 6(6):795-800; doi:10.1016/j.ejheart.2004.08.002
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© 2004 European Society of Cardiology

The diagnosis of heart failure in primary care: value of symptoms and signs

Cândida Fonsecaa,*,1, Humberto Moraisb,2, Teresa Motac,3,4, Fernando Matiasb,2, Catarina Costab,2, António Gouveia-Oliveirad,5, Fátima Ceiae,1,6 and on behalf of the EPICA Investigators7

a Department of Internal Medicine, Medical Sciences School New University of Lisbon, Lisbon, Portugal
b EPICA Working Group Lisbon, Portugal
c Department of Cardiology, Medical Sciences School, New University of Lisbon Lisbon, Portugal
d Datamedica Ltd. Lisbon, Portugal
e Department of Medical Therapeutics, Medical Sciences School, New University of Lisbon Lisbon, Portugal

* Corresponding author. Current address: R. Salvador Barata Feyo n° 1 r/c D.to 2780-335 Oeiras, Portugal. Tel.: +351 21 443 81 61; fax: +351 21 301 7958.. E-mail address: candidafonseca{at}netc.pt


   Abstract
Top
 Notes
 Abstract
1. Introduction
 2. Methods
 3. Results
 4. Discussion
 References
 
Background: The value of symptoms and signs in the diagnosis of CHF has rarely been tested in large numbers of patients in the community. The aim of this study was to evaluate the importance of symptoms, signs, and past medical history in the diagnosis of CHF in primary care.

Methods: Data on a sample of Portuguese men and women attending 365 primary care centres for any condition other than the treatment of acute infection, metabolic conditions or pregnancy were collected. All subjects who scored three or more points in the sum of categories one and two of the Boston questionnaire (history and physical examination) and those being treated for heart failure with loop or thiazide diuretics were considered to have possible heart failure and referred for further assessment including a resting echocardiogram. The sensitivity, specificity, positive predictive value, negative predictive value and likelihood ratio (LR) for the diagnosis of heart failure were calculated.

Results: A total of 5434 subjects were identified, of whom 1058 fulfilled the criteria for further assessment; 551 subjects had cardiac dysfunction at rest, of which 35.5% were in NYHA class I and 4.9% in class IV. Prior use of digoxin (LR 24.9) and/or diuretics (LR 10.6), a history of coronary artery disease (LR 7.1) or of pulmonary oedema (LR 54.2), were associated with a greater likelihood of having heart failure. Amongst current symptoms, a history of paroxysmal nocturnal dyspnoea (LR 35.5), orthopnea (LR 39.1) and breathlessness when walking on the flat (LR 25.8) were associated with a diagnosis of heart failure. However, these symptoms were not frequent amongst patients with heart failure within this population (sensitivity <36%). Jugular pressure > 6 cm with hepatic enlargement, and oedema of the lower limbs (LR 130.3), a ventricular gallop (LR 30.0), a heart rate above 110 bpm (LR 26.7), and rales at pulmonary auscultation (LR 23.3) were all associated with a diagnosis of heart failure, but were infrequent findings in patients with heart failure (sensitivity <10%).

Conclusions: Symptoms and signs, and clinical history had limited value in diagnosing heart failure when used alone. The signs and symptoms that best predicted a diagnosis of heart failure were those associated with more severe disease. If investigation is limited to patients with more definite symptoms and signs of heart failure, fewer than 50% of cases will be identified and a large number of patients with mild symptoms will be missed.

Key Words: Chronic heart failure • Diagnosis • Symptoms and signs • Primary care

Received July 6, 2004; Accepted August 25, 2004


   1. Introduction
Top
 Notes
 Abstract
 1. Introduction
2. Methods
 3. Results
 4. Discussion
 References
 
There seems to be general agreement that the diagnosis of chronic heart failure (CHF) is not secure when based only on medical history, symptoms and signs. The presence of symptoms should increase clinical suspicion and lead to further investigation [1]. However, setting the threshold that triggers investigation remains problematic. Too low a threshold could overwhelm resources. Too high a threshold will miss the diagnosis.

The value of symptoms and signs in the diagnosis of CHF has rarely been tested in large numbers of patients representative of those found in the community [2-8]. Most studies have investigated hospital populations (in- or out-patient referrals), which are a selected group with more severe CHF [2-7], a problem identified by the authors. The accuracy of clinical diagnosis found in those studies should not be generalized to the whole population. Recent studies of less selected populations referred for evaluation of cardiac function because of a clinical suspicion of CHF showed that only 25-60% of the patients had cardiac dysfunction at rest, emphasising that clinical criteria alone are an insufficient basis for the diagnosis of CHF [8-13]. One other criticism of these studies is that with few exceptions [13], they have focused mainly on left ventricular systolic dysfunction.

The aim of the present study was to evaluate the importance of medical history, symptoms and signs in diagnosing CHF in the primary care setting, using the echocardiographic criteria established for the EPICA trial for the different types of cardiac dysfunction [14].


   2. Methods
Top
 Notes
 Abstract
 1. Introduction
 2. Methods
3. Results
 4. Discussion
 References
 
EPICA was a cross-sectional observational study of subjects attending primary health care centres in the community [14]. The sampling method was a combined stratified and two-stage random sampling. The primary sampling units were primary health care centres in the community. In order to ensure national coverage, health care centres were randomly selected from every district by sampling proportional to the population. In each primary health care centre, the subjects were enrolled in the study by systematic sampling and stratified by age: 25-49, 50-59, 60-69, 70-79, and >80 years.

The sample size requirements were defined on the basis of a desired prevalence precision of 1% in each stratum and an overall precision of 0.4%. Five hundred centres were randomized for inclusion in this study, each centre being assigned to enroll 26 subjects. In each centre, the subjects were enrolled in the corresponding age groups consecutively, in proportions of 2, 2, 4, 6, and 12 subjects, respectively. The study was approved by the National Medical Council, the Regional Health Authorities and the Ministry of Health. Informed consent was obtained from all the subjects included in the study, 36 individuals (0.057%) refused to participate.

All patients with whom the investigators had contact were eligible for inclusion in the study. This included patients attending primary health care centres, as well as institutionalized subjects and subjects visited at home. Patients attending for specialized consultations (e.g., diabetes, hypertension), or for the treatment of acute infectious or metabolic conditions, were excluded from the study.

The Boston questionnaire was selected as the screening instrument [15]. A Portuguese version was prepared by the translation-back translation method. Subjects scoring up to two points in the sum of part I (symptoms) and part II (physical examination) of the Boston questionnaire, and who were not taking any medication for chronic heart failure (loop or thiazide diuretics in monotherapy or in association with ACE-inhibitors, digitalis or hydralazine plus nitrates) were considered as not having criteria for CHF. All subjects scoring three or more points in the sum of parts I and II, or with any of the above treatments irrespective of the score, were subjected to further investigation with a chest X-ray, 12-lead electrocardiogram, M-mode and bi-dimensional echocardiography, peak-flow evaluation and a laboratory evaluation. In accordance with the ESC Guidelines, the following examinations were performed: haemogram, blood glucose, blood urea, creatinine, albumin and electrolytes and TSH in subjects with atrial fibrillation or suspected thyroid dysfunction [1].

Heart failure was defined as a syndrome recognized by the physician on the basis of symptoms of exercise intolerance, signs of fluid retention and response to therapy, accompanied by objective evidence of cardiac dysfunction at rest, according to the Guidelines of the ESC Working Group on Heart Failure [1].

A total score of three or more points in the sum of parts I and II of the Boston questionnaire was considered sufficient indication of the presence of symptoms and signs of exercise intolerance and/or fluid retention. Objective evidence of cardiac dysfunction at rest was accepted when one or more of the following were observed by echocardiography: (1) left ventricular (LV) shortening fraction below 28%; (2) severe LV segmental dyskinesia and LV enlargement; (3) LV mass index greater than 134 g/m2 in males and 110 g/m2 in females; (4) LV posterior wall and interventricular septum thickness greater than the 95 percentile of the predicted value; (5) left atrial diameter greater than the 95 percentile of the predicted value; (6) moderate to severe valvular lesions; (7) moderate to severe pericardial effusion; (8) right ventricular dilatation. Predicted values based on gender, age and body surface area were obtained from Henry's equations [16-19].

The following six subtypes of heart failure were defined, based on the echocardiographic findings: (1) moderate to severe valvular disease was classified as heart failure due to valvular disease; (2) moderate to severe pericardial effusion was classified as heart failure due to pericardial disease; (3) right ventricular dilatation was classified as right heart failure; (4) multiple anomalies in which the predominant anomaly was impossible to identify with a single echocardiographic examination were classified as multifactorial heart failure; (5) LV shortening fraction below 28%, or severe LV dyskinesia and LV dilatation were classified as heart failure due to systolic dysfunction; (6) LV shortening fraction above 28% without severe LV dyskinesia, or with left atrial dilatation, or increased LV mass index, or increased thickness of the LV posterior wall or inter-ventricular septum were classified as heart failure with preserved systolic function.

The study protocol, study procedures and data-collection forms were presented to all participating investigators during training sessions before commencing the study. The subjects' data was collected on structured forms suitable for optical character recognition and included demographic data, the Boston questionnaire, six other questionnaires for the diagnosis of heart failure (Framingham, Gothenburg, Duke, Walma, Gheorghiade and NHANES-I), present medication, NYHA classification of heart failure, aetiological factors and associated diseases. Selected chest X-ray findings (cardiomegaly, cardio-thoracic ratio, alveolar pulmonary oedema, interstitial pulmonary oedema and bilateral pleural effusion) were recorded by the radiologist on a structured form. ECG and echo findings were also recorded on structured forms.


   3. Results
Top
 Notes
 Abstract
 1. Introduction
 2. Methods
 3. Results
4. Discussion
 References
 
Of the 6300 primary health care attendants enrolled in the EPICA study between April and October 1998, 5434 were eligible for analysis. This population included 2025 men (37.3%) and 3409 women with a mean age of 68±15 years. One thousand and fifty-eight subjects scored three or more points in the sum of categories I and II of the Boston questionnaire, or were receiving diuretics and were labelled as possible heart failure and underwent further assessment. Echocardiographic examinations were attempted in 1022 patients. Complete measurements could not be obtained in 174 subjects (17%) because of a poor echocardiographic window. These patients were excluded from the analysis.

The presence of cardiac dysfunction at rest was identified by echocardiography in 551 cases. The population estimate of the distribution of heart failure by NYHA functional classes was 35.4% in class I, 29.9% in class II, 23.5% in class III, and 4.9% in class IV; 6.2% were not classified [14]. Table 1 presents the estimated prevalence of the different types of cardiac dysfunction found by echocardiography in the Portuguese population. The sensitivity, specificity, positive and negative predictive values, and likelihood ratio of the data from the clinical history, symptoms and signs of all 5434 patients enrolled, for the diagnosis of heart failure are presented in Tables 2-4GoGo.


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  		Table 1 Estimated prevalence of different types of cardiac dysfunction in the Portuguese population

 


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  		Table 2 Value of past clinical history including prior use of possible treatments for heart failure

 


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  		Table 3 Value of symptoms

 


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  		Table 4 Value of physical findings

 
From past medical history data, prior administration of digitalis (LR 24.9) and/or diuretics (LR 10.6) had a high correlation with the diagnosis of heart failure. A history of coronary artery disease had a moderate correlation with the diagnosis of CHF (LR 7.1).

Regarding symptoms of dyspnoea and exercise intolerance, a history of pulmonary oedema (LR 54.2), a history of paroxysmal nocturnal dyspnoea (LR 35.5), orthopnea (LR 39.1) and dyspnoea when walking on the flat (LR 25.8) were most often related to the diagnosis of CHF. However, these symptoms were not frequent in patients with heart failure within this population (sensitivity <36%). The physical signs that were most related to CHF were jugular venous pressure >6 cm with hepatic enlargement and oedema of the lower limbs (LR 130.3), a ventricular gallop (LR 30.0), a heart rate above 110 bpm (LR 26.7), and rales at pulmonary auscultation (LR 23.3). All these findings were infrequent in patients with CHF in this population (sensitivity <10%).

Of the 551 patients eventually diagnosed with heart failure, 134 had a Boston Score of 3-4, 121 had a Boston Score of 5-7, 71 a Boston score of 8-9 and 125 a Boston score of >10.


   4. Discussion
Top
 Notes
 Abstract
 1. Introduction
 2. Methods
 3. Results
 4. Discussion
References
 
Signs, symptoms and clinical history had a limited value in diagnosing CHF when used as the only tool. Objective evidence of cardiac dysfunction was present in only 54% of patients with heart failure based on the clinical criteria we used. No clinical feature predicted heart failure with high sensitivity, specificity and positive and negative predictive values.

The utility of a test (sensitivity, specificity and positive and negative predictive values) depends on the type of population studied and the criteria required for diagnosis. We used the ESC guidelines to provide a diagnostic standard rather than relying on invasive measurements that are of questionable relevance to patients with heart failure in the community [2-7]. Our population was more representative and larger than most of the other previously studied population [9-13].

In the present paper, the findings in the clinical history that were most strongly related to the diagnosis of CHF were the administration of digitalis and/or diuretics. A history of coronary artery disease was only moderately related. This contrasts with the report of Davie et al. [11], investigating the utility of symptoms and signs for the diagnosis of heart failure due to left ventricular systolic dysfunction. Coronary heart disease is the main aetiology of this type of cardiac dysfunction and this may account for the difference. In our study, CHF with preserved systolic function was common (1.7%) and hypertension was the most frequent risk factor/aetiology [14,20]. This is in agreement with other reports [21,22]. In EPICA, a history of coronary disease was associated with a LR of 6.8 for heart failure due to left ventricular systolic dysfunction, compared to 7.1 in the overall population.

The diagnostic accuracy of breathlessness and exertional intolerance (current and previous) is strongly related to the severity of these symptoms. Thus, a history of acute pulmonary oedema, paroxysmal nocturnal dyspnoea, orthopnea and dyspnoea when walking on the flat were relatively specific but identified only a minority of patients. Most patients had mild symptoms [2,14]. As in other studies [2-5], exertional dyspnoea was the most frequent symptom among patients with CHF. Nevertheless, the PPV and LR are low because the prevalence of these symptoms is high in the general population [23].

Several studies have evaluated the value of signs for the diagnosis of heart failure. In our study, in agreement with other reports [2-6,24], signs were not very sensitive but relatively specific. The signs that best predicted the diagnosis of CHF were jugular venous pressure >6 cm with hepatic enlargement and oedema of the lower limbs, a ventricular gallop, a heart rate >110 bpm and extense rales at pulmonary auscultation, as observed by others [2,3,5,6]. The low sensitivity of signs may not only reflect the fact that many patients had only mild heart failure but also the inability of physicians to detect specific signs [6]. Unfortunately, an assessment of the apical impulse [5,11,24] was not recorded in the EPICA study; this sign may be a good predictor of left ventricular systolic dysfunction [11].

The specificity of symptoms and signs was higher compared to other studies, without loss of sensitivity. This may be due to the inclusion in this study of all the types of CHF, not only those due to systolic dysfunction. A positive test in a patient with heart failure and preserved left ventricular systolic function would count as a false positive for systolic dysfunction but a true positive for heart failure. The high negative predictive values of symptoms and signs are not very relevant in practice, because they include the whole population and not just patients with heart failure. Therefore, the observation that a random person in the population does not have the symptom or sign only decreases his or her probability of having heart failure by a small amount. Given the low prevalence of heart failure in the population, the negative predictive values would be useful only if they were near 99.9%.

The clinical diagnosis of heart failure in the early, relatively asymptomatic stages of heart failure is a major challenge. Signs and symptoms are rare and dyspnoea on exertion, although very sensitive is not specific.

This study provides unique insights into the epidemiology of heart failure in general and specifically in Portugal. Nonetheless, we acknowledge many limitations. It is not possible to eliminate inter- and intra-observer variation in the evaluation of signs and symptoms, which is highly dependent on experience and skill [25]. The echocardiograms were not all performed in the same reference laboratory. Nevertheless, both aspects reflect clinicians' everyday reality. This study focused on the epidemiology of heart failure and not of cardiac dysfunction. We do not know what the prevalence of cardiac dysfunction is in patients with Boston scores lower than three.

In conclusion, EPICA confirms the advice from the ESC that objective evidence of the presence of disease should be sought in all patients with suspected heart failure in the same way as for other treatable malignant diseases. The threshold of suspicion which should trigger investigation requires further research. The ACC/AHA guidelines [26] classify patients into stages A, B, C, or D. Patients in stages A and B by definition do not have symptoms of heart failure and can rarely be detected by signs. Nevertheless, primary care teams should attempt to detect patients at risk of developing heart failure in order to try and delay its onset. This requires assessment for predisposing risk factors for cardiac dysfunction.


   Acknowledgements
 
The EPICA Project is supported by Servier Research Group, and has the scientific sponsorship of the Portuguese Society of Cardiology and of the Working Group on Heart Failure of the European Society of Cardiology. We are especially grateful to Prof. John G. Cleland for his advice. The authors are indebted to the EPICA investigators, without whom this work would not have been possible. We are grateful to Dr. Micaela Seeman Monteiro for revising the manuscript.


   Notes
Top
 Notes
Abstract
 1. Introduction
 2. Methods
 3. Results
 4. Discussion
 References
 
1 Serviço de Medicina, Hospital S. Francisco Xavier, 1400 Lisboa, Portugal. Back

2 Grupo de Investigação EPICA, Av António Augusto de Aguiar 128, 1050 Lisboa, Portugal. Back

3 Serviço de Cardiologia, Hospital Pulido Valente, 1750 Lisboa, Portugal. Back

4 Current address: R. do Loreto no° 34-3° 1200 Lisboa, Portugal. Back

5 Datamedica, R. Garcia de Orta 70, 2 D, 1200 Lisboa, Portugal. Back

6 Current address: Av. Grão Vasco 47-1°-Esq 1500-336 Lisboa, Portugal. Back

7 EPICA Investigators and Steering Committee Members are listed in appendix (DOI: 10.1016/j.ejheart.2004.09.002). Back


   References
Top
 Notes
 Abstract
 1. Introduction
 2. Methods
 3. Results
 4. Discussion
 References
 

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