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European Journal of Heart Failure 2009 11(1):92-98; doi:10.1093/eurjhf/hfn006
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Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2009. For permissions please email: journals.permissions@oxfordjournals.org.

Adequacy of diagnosis and treatment of chronic heart failure in primary health care in Sweden

Ulf Dahlstrom1,*, Jan Hakansson2, Karl Swedberg3 and Anders Waldenstrom4

1 University Hospital, Cardiology Linköping, Sweden
2 Dep Primary Care Center, Krokom, Sweden
3 Department of emergency and cardiovascular medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
4 University Hospital, Heart Center, Umeå, Sweden

* Corresponding author. Email: ulf.dahlstrom{at}lio.se


   Abstract
Top
 Abstract
Introduction
 Methods
 Results
 Discussion
 Authors' contribution
 Funding
 Appendix
 References
 
Aims: We performed an observational multicentre study to obtain information of the diagnostic tools and treatments currently used in patients with chronic heart failure (CHF) in primary health care (PHC) in Sweden. Data were collected from 2093 patients in 158 randomly selected PHC centres.

Methods and results: The mean age was 79 years. The dominating aetiology of HF was hypertension and/or ischaemic heart disease. Diagnosis was based on symptoms and/or ECG and/or chest X-ray in 69% of the patients. Treatment with a renin–angiotensin system (RAS) blocker was ongoing in 74% of the patients, but only 37% had ≥50% of the recommended target dose. In 68%, treatment with a beta-blocker (BB) was present, but only 31% had ≥50% of the recommended target dose. Only 42% of the patients were on treatment with an RAS blocker and a BB and only 20% had ≥50% of the recommended target dose.

Conclusion: The diagnostic criteria for CHF according to the European Society of Cardiology were fulfilled in only ~30% of the patients. In addition, evidenced-based treatments to reduce morbidity and mortality were markedly underused, particularly regarding dosing. Our findings may reflect the patients’ high age and the presence of important co-morbidities.

Key Words: Heart failure • Primary health care • Diagnosis • Treatment

Received February 25, 2008; Revised September 1, 2008; Accepted September 8, 2008


   Introduction
Top
 Abstract
 Introduction
Methods
 Results
 Discussion
 Authors' contribution
 Funding
 Appendix
 References
 
Heart failure (HF) is a demanding and growing medical problem in the developed world. With a growing ageing population, the prevalence of HF has increased substantially. It is estimated that about 200 000–300 000 patients are suffering from symptomatic HF in Sweden today and a similar number of patients have significant left ventricular dysfunction.1

The diagnosis of chronic HF (CHF) is associated with high mortality, morbidity, and suffering.1 During the past 10–15 years, effective pharmacological treatments have been documented, resulting in a marked reduction in mortality and morbidity.2 Because long-term survival among patients hospitalized for HF in Sweden has improved markedly during this period, these treatments are obviously important in the management of patients with a diagnosis of HF.

Despite numerous reports on HF in hospital settings, there are few studies on how patients in primary health care (PHC) are diagnosed and treated. These patients are often elderly and have a number of co-morbidities that may influence treatment. Updated European and Swedish guidelines on HF have been published.1 The Swedish Medical Products Agency initiated the ‘Hand on the Heart’ project to help to communicate these new guidelines to Swedish health care professionals. This project, which is run by the Swedish Heart and Lung foundation, is supported by several organizations, including the Swedish Society of Cardiology, the Swedish Association of Family Medicine, and several pharmaceutical and diagnostic companies. The present study was performed as an initial step of this project, where the aim was to perform a survey of the diagnostic tools and treatments currently used in patients with HF in a Swedish PHC setting.


   Methods
Top
 Abstract
 Introduction
 Methods
Results
 Discussion
 Authors' contribution
 Funding
 Appendix
 References
 
Design
This was a non-interventional, retrospective, observational, multi-centre study to register historical and current data on the diagnosis and treatment of the 10–15 latest consecutive patients with a diagnosis of HF and that received pharmacological treatment for HF. These patients had visited a PHC facility between January 2004 and January 2006. The study was planned to include data from at least 2000 patients from approximately 200 Swedish PHC centres. The 200 centres were randomly selected from 1024 PHC centres in Sweden. To obtain a broad geographical representation of Sweden, the selection was stratified according to health care administrative units (counties) and proportional to the inhabitants in the county.

Study variables
The variables registered in each patient are shown in Appendix.

All data were entered in a web-based computerized data-capture system at the study centres. The principal investigator at each centre was responsible for entering data on the observations, tests, and assessments and treatments specified in the study protocol into the web-based system and according to the electronic case report form instructions.

Statistics
The results are presented as percentage or mean ± [standard deviation (SD)]. The analyses were performed using mainly descriptive statistics. A P-value <0.05 was considered significant. All data analyses were performed using commercially available statistical analysis software packages (SAS/V8.2 or higher). A linear multivariate model was set up for target doses for both treatments considering the effects of gender, age, New York Heart Association (NYHA) class, location where the diagnosis was made, and the centre.

The study protocol was approved by the Ethics Committee at the Faculty of Health Sciences, Linköping University.


   Results
Top
 Abstract
 Introduction
 Methods
 Results
Discussion
 Authors' contribution
 Funding
 Appendix
 References
 
Patients
In order to recruit the target number of centres, 997 centres had to be invited. This is because only 18% (176) of the centres agreed to participate. Only 158 of these centres recruited patients. The centre distribution was grouped in accordance with different geographical areas. A minimum of five centres were secured for each geographical area.

Age and gender
Registration included 2093 patients with more men (55%) than women. The patients’ characteristics are given in Table 1. The overall mean age was 79 (10) years (range 19–104): the mean age for men and women was 78 (10) years and 81 (9) years, respectively. Most patients were 80 years or older (56%).


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  		Table 1 Baseline characteristics

 
Concomitant diseases
Ischaemic heart disease and hypertension were the most commonly reported co-morbidities (59 and 57%, respectively). A history of other severe somatic diseases was found in 32% of the patients, where 25% had diabetes and 8% severe psychiatric disease or dementia (Table 1). A majority of patients (73%) had two or more other important co-morbidities.

Signs or symptoms and New York Heart Association class
Common symptoms/signs were dyspnoea (60%), fatigue (45%), and peripheral oedema (36%). The pattern of HF signs and symptoms generally conformed to what was anticipated on the basis of the NYHA classification.

Forty-one per cent of the patients were classified as NYHA class II (Table 1). Slightly more men than women were classified as NYHA class III (25 vs. 22%) and NYHA class IV (8.3 vs. 6.1%). Mean age increased from 77 (11) years in NYHA class I to 82 (9) years in NYHA class IV.

Vital signs and laboratory values
Mean blood pressure was 135 (21)/76 (11) mmHg. Only 105 patients (5%) had substantial hypotension (systolic blood pressure <105 mmHg).

Mean heart rate was 73 (14) b.p.m. Sixty-two per cent of the patients had a heart rate ≥80 b.p.m. Atrial fibrillation was more frequent in patients with a heart rate ≥80 b.p.m. than patients with a heart rate <80 b.p.m. (57 and 40%, respectively).

Mean haemoglobin (Hb) was 135 (16) g/L. In 498 patients (26%), the Hb value was <125 g/L (defined as mild anaemia according to the WHO criteria) and in 62 (3%) <105 g/L.

Mean serum-creatinine was 105 (39) umol/L. In 535 patients (27%), the serum-creatinine value exceeded 125 µmol/L.

A BNP/NT-proBNP level was documented in only 48 patients (2%).

Diagnosis
The diagnosis of HF was based on symptoms alone in 29% of the patients (female 33% and male 26%). Echocardiography was part of the diagnostic procedure in only 559 patients (31%, female 21% and male 39%). Among the 69% of patients in whom the diagnosis was done without echocardiography, the diagnosis was based on symptoms alone in 29%, on symptoms and ECG in 13%, on symptoms and ECG and chest X-ray in 13%, and on symptoms and chest X-ray in 14%.

In those patients in whom ejection fraction (EF) was assessed, 47% had an EF <40%, and 22% had a normal EF (≥50%). The diagnosis was performed in ~50% of the patients in a hospital setting and in 40% in a PHC setting.

Treatment
An angiotensin-converting enzyme-inhibitor (ACE-I) was part of the treatment in 1140 patients (54%), mostly enalapril (n = 601) and ramipril (n = 400), with no difference between genders. The main reasons for not using an ACE-I were active deselection (physician decision that a patient should not receive the recommended treatment) in 10% and prior side effects in 12%. Decreasing renal function was also a contributing factor in the higher NYHA classes (1.3% in NYHA class I vs. 8.4% in NYHA class IV).

In 21% of the patients, treatment with an angiotensin II receptor blocker (ARB) was ongoing, mostly losartan (n = 252) and candesartan (n = 122). Fewer women than men were prescribed this option. Active deselection (32%) together with unknown reason (27%) were the main reasons for not using an ARB. Decreasing renal function was a contributing factor for not using ARBs in the higher NYHA classes (1.5% in NYHA class I vs. 5.8% in NYHA class IV).

Treatment with renin–angiotensin system (RAS) blockade, i.e. either an ACE-I or an ARB, or both, was used in 1551 patients (74%). Only 37 patients (2%) were given the combination of an ACE-I and an ARB. There was no notable difference in RAS blockade between genders or NYHA classes. Unknown (14%), decreased renal function (7%), and active deselection (7%) were the main reasons for not using RAS blockade.

A beta-blocker (BB) was used in 1412 patients (67%), mostly metoprolol (n = 694) and bisoprolol (n = 338) but also atenolol (198). There were no gender differences or differences between NYHA classes for BB usage. The main reasons for not using a BB were unknown (13%), active deselection (9%), and side effects (5%).

The medication was originally prescribed by a primary care physician in 29% for ACE-Is, 47% for ARBs, and 37% for BBs.

Only 876 patients (42%) were treated with a combination of RAS blockade (ACE-I and/or an ARB) and a BB.

Target doses for treatment with ACE-Is, ARBs, and BBs are defined in current European and Swedish guidelines.1 Only 50% of the patients on RAS blockade were achieving at least 50% of the target dose: the corresponding figure for BB therapy was 26%. The percentages of patients reaching different levels of the target dose (<50%, ≥50% and <100%, >100%) for both RAS blockade and BBs are shown in Figure 1. Only 6% (5% of the females) were treated with 100% of the target doses and only 20% (17% of the females vs. 22% of the males) received ≥50% of the target dose.


Figure 1
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  		Figure 1 Percentages of patients reaching different target dose levels (<50%, ≥50% and <100%, >100%) for blockade of the renin–angiotensin system (RAS) as well as beta-blockade (BB).

 
The multivariate model showed that age, diagnostic methods used, and location where the diagnosis was confirmed were important determinants for reaching target doses, whereas gender and NYHA class were not. As depicted in Figure 2, the target dose of RAS blockade was found to significantly attenuate with increasing age, starting at about 55 years of age. When echocardiography was used as a diagnostic method and the diagnosis was confirmed at hospital, it was more likely that the target doses would be reached.


Figure 2
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  		Figure 2 Per cent blockade of the renin–angiotensin system (RAS) by age adjusted for difference in sex, centre, New York Heart Association class, and where the first diagnosis was issued.

 
Other concomitant medications are listed in Table 2. The number of drugs taken by each patient, other than those for HF and those specified above, ranged from 0–22, with most patients taking two additional drugs, which reflects the severe medical condition for many of the patients. The overall mean of all drugs taken regularly, including drugs for HF, was 7.2, increasing from 6.6 in NYHA class I to 7.9 in NYHA class IV.


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  		Table 2 Other concomitant medication

 

   Discussion
Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
Authors' contribution
 Funding
 Appendix
 References
 
This study suggests that current diagnostic and treatment practice for HF in the PHC sector in Sweden is suboptimal. Only 30% of the patients had been evaluated by echocardiography and only 6% received treatment, to achieve full neurohormonal blockade. Moreover, only 20% received at least 50% of the target dose recommended by national and international guidelines.

Although only 18% of invited centres participated, these centres were invited by random sampling and stratified regions. Centres received a modest reimbursement of 1000 SEK per included patient. Similar low figures of participation rate were obtained in the IMPROVEMENT trial for Sweden (22%).3 Owing to the difficulties involved in enrolling primary care centres, there is probably a bias of motivated centres, which might result in a positive selection bias. However, patient demographics were in accordance with previous reports, suggesting that our study population is representative of patients with HF in the PHC sector in Sweden. The challenges we encountered in centre recruitment (in particular, the low response rate) may illustrate the barriers that will occur if a voluntary quality initiative is to be performed in the primary care setting in Sweden.

In contrast to studies in hospital-based HF patients,4–6 the mean age of the present patients is much higher and probably reflects the true mean age of patients with HF in the community.7 There are more men than women in this study, which is in contrast to what is found in most community studies. The majority of patients had mild-to-moderate HF and were in NYHA class I–II (60%); however, there were some patients with severe HF in NYHA class IV (8%). Most patients had normal blood pressure and renal function and no anaemia, which, in addition to other information (NYHA classification and EF), suggest that they did not have advanced HF. Heart rate >80 b.p.m. was recorded in 62% of the patients despite concurrent treatment with a BB. However, as 57% of these patients had atrial fibrillation, ventricular rate did not seem to be fully controlled because only 22% were on digoxin therapy. Although 48% of patients had atrial fibrillation, only 28% were treated with warfarin. Many elderly patients with atrial fibrillation were probably treated with aspirin, as 51% of the patients were receiving such therapy. In a registry study from Japan which included patients with a mean age of 74 years, prevalence of atrial fibrillation was reported to be 42%.8

Co-morbidities are definitively a problem among elderly HF patients. The majority of our patients had two or more concomitant diseases in addition to HF, and with increasing severity of the syndrome, the number of concomitant diseases increased up to an average of four. Importantly, 32% of the patients had another severe somatic disease and 8% had a psychiatric disease or dementia, confounding the HF diagnosis. These findings are consistent with other reports.9 Another issue in elderly HF patients concerns polypharmacy.10,11 Our patients were prescribed, on average, seven drugs, reflecting the severe medical condition of our patient sample.

The most frequent symptom was dyspnoea, which was reported in 60% of the patients. In general, rating of symptoms was low in records. NYHA class, however, which denotes symptom severity, was reported in 93% of our patients, a finding in contrast with other studies that have reported a low use of NYHA classification.12 This classification, however, is not a direct classification of the symptom experience but relates to the caregiver’s interpretation of the patients’ symptoms.

Diagnosis
The diagnosis of CHF was established by signs/symptoms in only 29% of the patients. Current European and Swedish guidelines state that the diagnosis should be confirmed by objective evidence of cardiac dysfunction, preferably by echocardiography. Yet, echocardiography was used to confirm HF diagnosis in only 31% of the patients, which implies that most patients diagnosed with HF did not meet the recommended diagnostic criteria. A gender-related difference was observed, indicating that echocardiography was used less frequently in women (21 vs. 39%). In three other studies evaluating HF in PHC in Sweden, the use of echocardiography was found to vary from 8 to 31%.7,13,14 In one of the studies,7 a strong gender difference was noted with less use of echocardiography in women, an observation in good accordance with our findings. In contrast, the IMPROVEMENT study in primary care in 14 countries showed that the HF diagnosis was supported by echocardiography in 82% of patients (68% in Swedish patients).3 However, in a follow-up report in which the opinions of the participating physicians regarding the value of echocardiography were assessed, echocardiography was regarded as having low diagnostic value, with only 48% routine usage (34% in Sweden).12

In many studies, it has been shown that symptoms/signs, electrocardiogram, and chest X-ray do not provide a reliable diagnosis of HF in a community setting.15–17 In contrast, only 31% of our patients (and only 27% of the female patients) had an objectively verified diagnosis.

Therapy
The majority of our patients (74%) were prescribed RAS blockade (78% in men and 69% in women) as well as a BB (67%). These results are in contrast to many other studies in which a much lower use of RAS blockade3,13,14,18–20 and BB3,13,14,19,20 was found. The much lower use of a BB probably reflects that the key studies documenting beneficial effects were published in 1999,6,21 whereas the studies cited above were published during 2002–2004. In contrast, in a recently published study by Majeed et al.,22 which reported similar findings to our study, RAS blockade was used in 76% of the men and 68% of the women. The use of a BB was not reported, however. A possible explanation for the high use of RAS blockade as well as BB might be that these agents were originally initiated to treat hypertension and/or ischaemic heart disease and not HF.

The recommended treatment according to European and Swedish guidelines in patients with HF is a combination of an RAS inhibitor and a BB. However, such a combination was only prescribed in 42% of our patients. Moreover, in the IMPROVEMENT trial3 and the study by Watz et al.,14 a combination therapy was used in only 20% of the patients. Concerning the target doses proposed from large controlled studies with beneficial effects, only 50% of the patients with RAS blockade and only 26% of the patients with BB were achieving ≥50% of the target dose. Concerning the recommended combination treatment with RAS blockade and BB, only 20% of the patients attained ≥50% of the target dose and only 6% were prescribed 100% of the target dose. Such findings indicate a marked underdosage of recommended drugs according to current European and Swedish guidelines (Figure 1). There was an age gradient, with older patients receiving lower target doses than younger patients for the combination treatment. In addition to age, other important factors in achieving target doses were diagnostic methods used and the location where the diagnosis was confirmed. Gender and NYHA class had no impact on target doses. Explanations to account for this difference might include co-morbidities, age, frail patients, and less specific recommendations in earlier guidelines.

Barriers to the use of recommended drugs have been explored in detail in two studies.23,24 The major obstacles found were lack of time, high cost of drugs, uncertainty of the diagnosis, and concerns about using recommended drugs in elderly, frail patients with co-morbidities and polypharmacy. Other concerns included initiation of recommended drugs and their possible side effects, and finally, doubts about the applicability of research findings to PHC. Recently, Remme et al.25 reported on the awareness of HF among the medical profession including primary care physicians. They demonstrated that the low adherence to diagnostic procedures as recommended in guidelines was general across Europe, and the Swedish primary care physicians belonged, if anything, to the high adherers. Thus, barriers to guideline implementation are common across Europe. It has been shown that co-morbidities have a clear impact on how recommended drugs are prescribed in the sense that the physician has to take competing therapeutic requirements and drug interactions into account.9

It can be argued that the proposed target doses that are used in large controlled studies and showing beneficial effects are not relevant for these elderly, frail patients with many co-morbidities and a risk of polypharmacy consequences. These dose levels have been achieved by forced dose titration in stable and younger patients. On the basis of this uncertainty, we considered 50% of a recommended target dose to be optimal in our patients, but still only 20% of the patients achieved this level of the target dose.

Conclusion
This study, which was carried out in a primary care setting, clearly showed an underutilization of diagnostic procedures in patients with HF. In addition, evidenced-based treatments to improve morbidity and mortality were underused, particularly regarding dosing according to recommended European and Swedish guidelines. Old age and high co-morbidity can partly explain these discrepancies. The implications of these findings on survival, quality of life, and costs for society remain to be elucidated.


   Authors' contribution
Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 Authors' contribution
Funding
 Appendix
 References
 
J.H., K.S., and A.W. have contributed significantly to this study with study design, performance of the study, evaluation of the data, and finally contributed to the writing of the manuscript. U.D. has the responsibility of, except from the other contributions (design, performance, evaluation, writing), being in close contact with the operational procedures, and also to have the superior responsibility of organizing data and data evaluation and writing the first draft to a manuscript.

Conflict of interest: none declared.


   Funding
Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 Authors' contribution
 Funding
Appendix
 References
 
The study was sponsored by AstraZeneca, Sweden for data collection. U.D., K.S. and A.W. have served as consultants to or received research grants and/or honoraria from AstraZeneca and/or major pharmaceutical companies.


   Appendix
Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 Authors' contribution
 Funding
 Appendix
References
 
The following variables were recorded for each patient on the basis of the specific study protocol:

  • Age and gender.
  • Concomitant diseases: hypertension, ischaemic heart disease (including angina pectoris, myocardial infarction, coronary artery bypass grafting, or percutaneous coronary intervention), cardiomyopathy, valvular disorders (including valvular surgery), treated pulmonary disease, diabetes, implanted pacemaker, or the presence of severe somatic (malignant diseases or other severe somatic diseases preventing the patient to use recommended treatment for their HF) or psychiatric diseases (including dementia).
  • Signs and/or symptoms, including the assessment of dyspnoea, fatigue, and peripheral oedema.
  • NYHA functional classification.
  • Diagnostic methods used to verify the diagnosis of HF, including signs and/or symptoms, electrocardiogram, chest X-ray, echocardiography, and natriuretic peptides.
  • Place where diagnosed: in PHC or at hospital.
  • Time of diagnosis: more than 1 year ago or less than 1 year ago.
  • Blood pressure and heart rate.
  • Serum Hb and creatinine.
  • Ongoing treatments related to HF, i.e. ACE-I, ARB, and BB, including where the treatment was initiated, reason if not used and reason if target dose was not obtained. Target dosages were defined according to the dosages recommended in current European and Swedish guidelines.
  • Other drugs relevant to CHF were also registered (diuretics, aldosterone antagonists, cardiac glycosides, warfarin, aspirin or other platelet inhibitors, long-acting nitrates, statins, insulin, and peroral antidiabetics). Information was obtained on the number of other pharmacological therapies that the patients were given in order to assess their polypharmacy problem.


   Acknowledgements
 
We would like to thank AstraZeneca, Sweden, for performing the operational functions of this project.


   References
Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 Authors' contribution
 Funding
 Appendix
 References
 

  1. Swedberg K, Cleland J, Dargie H, Drexler H, Follath F, Komajda M, Tavazzi L, Smiseth OA, Gavazzi A, Haverich A, Hoes A, Jaarsma T, Korewicki J, Lévy S, Linde C, Lopez-Sendon JL, Nieminen MS, Piérard L, Remme WJ, Task Force for the Diagnosis and Treatment of Chronic Heart Failure of the European Society of Cardiology. Guidelines for the diagnosis and treatment of chronic heart failure (update 2005): The Task Force for the diagnosis and treatment of chronic heart failure of the European Society of Cardiology. Eur Heart J (2005) 26:1115–1140.[Free Full Text]
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K. Swedberg, M. Komajda, M. Bohm, J. S. Borer, I. Ford, and L. Tavazzi
Rationale and design of a randomized, double-blind, placebo-controlled outcome trial of ivabradine in chronic heart failure: the Systolic Heart Failure Treatment with the If Inhibitor Ivabradine Trial (SHIFT)
Eur J Heart Fail, January 1, 2010; 12(1): 75 - 81.
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 Eur J Heart FailHome page
A. Jonsson, M. Edner, U. Alehagen, and U. Dahlstrom
Heart failure registry: a valuable tool for improving the management of patients with heart failure
Eur J Heart Fail, January 1, 2010; 12(1): 25 - 31.
[Abstract] [Full Text] [PDF]

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 Eur J Heart FailHome page
K. Swedberg
What should we do about heart failure: challenges for 2009
Eur J Heart Fail, January 1, 2009; 11(1): 1 - 2.
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