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European Heart Journal Advance Access originally published online on December 22, 2007
European Heart Journal 2008 29(3):339-347; doi:10.1093/eurheartj/ehm554
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Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2007. For permissions please email: journals.permissions@oxfordjournals.org

Prognosis of heart failure with preserved ejection fraction: a 5 year prospective population-based study

Christophe Tribouilloy*, Dan Rusinaru, Haïfa Mahjoub, Vicky Soulière, Franck Lévy, Marcel Peltier, Michel Slama and Ziad Massy

Department of Cardiovascular Disease, INSERM, ERI 12, Amiens and University Hospital, Amiens 80054, France

Received 22 March 2007; revised 22 October 2007; accepted 29 October 2007; online publish-ahead-of-print 22 December 2007.

* Corresponding author. Tel: +33 3 22 45 58 83, Fax: +33 3 22 45 56 58. Email: tribouilloy.christophe{at}chu-amiens.fr

See page 285 for the editorial comment on this article (doi:10.1093/eurheartj/ehm597)


   Abstract
Top
 Abstract
Introduction
 Methods
 Results
 Discussion
 Conclusions
 References
 
Aims: This study was designed to identify the characteristics and long-term prognosis of heart failure with preserved ejection fraction (HFPEF) in patients hospitalized for a first episode of HF.

Methods and results: Consecutive patients (n = 799) hospitalized for a first episode of HF during 2000 in the Somme department (France) were recruited. EF was available in 662 (83%) patients, representing the study population. Patients with HFPEF (55.6% of cases) were significantly older, with a high proportion of women. During the 5 year follow-up, 370 patients (56%) died. Patients with HFPEF had a significantly lower 5 year survival than the age- and sex-matched general population (43 vs. 72%). Five year survival rates were not significantly different in patients with preserved and reduced EF (43 vs. 46%; P = 0.95). Both groups had similar relative 5 year survival rates compared with the general population. Multivariable analysis identified age, stroke, chronic obstructive pulmonary disease, cancer, diabetes, low glomerular filtration rate, and hyponatraemia as independent predictors of 5 year mortality in patients with HFPEF.

Conclusions: Heart failure with preserved ejection fraction has a poor prognosis, comparable with that of HF with reduced EF, with a 5 year survival rate after a first episode of 43% and a high excess mortality compared with the general population.

Key Words: Heart failure • Prognosis • Ejection fraction


   Introduction
Top
 Abstract
 Introduction
Methods
 Results
 Discussion
 Conclusions
 References
 
Heart failure (HF) represents a major health concern with an increasing prevalence in developed countries. It has now been clearly established that HF may occur in patients with preserved left ventricular (LV) ejection fraction (EF). The prevalence of HF with preserved ejection fraction (HFPEF) varies widely from 13 to 74%, depending on diagnostic criteria and population profiles.1 HFPEF appears to be frequent in older patients and women.2,3

Observational studies have led to contradictory data regarding the prognosis of HFPEF compared with systolic dysfunction. Available data on HFPEF are mostly based on ambulatory populations, with less information on hospitalized patients.4–6 Some studies show a better survival in patients with HFPEF,4,7,8 whereas others find similar survival rates, regardless of the EF.2,6,9–13 Most of these studies were observational retrospective studies.2,4,13,14

Few retrospective studies completed in the United States have focused on hospitalized patients with new-onset HF.2,15 European data specifically focusing on patients hospitalized for a first episode of HF are currently lacking. This issue is important, as prognosis may be different in patients hospitalized for the first time with HF and patients hospitalized for subsequent aggravations of HF.16 Moreover, few data are available on predictors of long-term mortality in patients with HFPEF.

The objectives of the current study, designed to follow prospectively a large cohort of consecutive patients hospitalized for a first episode of HF, were (i) to assess the clinical features, treatment, and prognosis of patients with HFPEF and (ii) to compare the long-term prognosis of patients with preserved EF with that of patients with reduced EF and with the expected survival.


   Methods
Top
 Abstract
 Introduction
 Methods
Results
 Discussion
 Conclusions
 References
 
Population and inclusion criteria
Somme is a fairly rural department of the North of France with a population of 555 551 inhabitants according to the 1999 census (i.e. 0.9% of the French population). It has a total of 11 healthcare establishments managing patients with HF: one university hospital, seven general hospitals, two private clinics, and one medium and long-stay unit. General practitioners, cardiologists, and internal physicians of these 11 centres agreed to participate in this prospective study. Consecutive patients over the age of 20 hospitalized for a first episode of HF in all these establishments during 2000 (from 1 January 2000 through 31 December 2000) were prospectively recruited. Patients with an assessment of the EF during the index hospitalization were included in the current study.

The diagnosis of HF was made by the attending physician in 811 patients, based on history, symptoms, physical signs, and chest X-ray on admission. Two cardiologists specifically recruited for this purpose reviewed, during the index hospitalization, all medical records in order to validate the diagnosis of HF according to the Framingham criteria amended by the European Society of Cardiology.17 The diagnosis was validated in 799 patients. A total of 137 patients (17%) in whom an EF assessment was not performed were excluded. Therefore, the study population included 662 patients.

Data collection
Clinical data including medical history and traditional cardiovascular risk factors were recorded on individual case report forms. Complementary investigations included laboratory tests, ECG, chest X-ray on admission, echocardiography, and in some patients coronary angiography.

Ejection fraction was determined during hospitalization by echocardiography (n = 648) and/or left ventriculography (n = 103). Echocardiograms were recorded in accordance with the guidelines of the American Society of Echocardiography.18 When more than one method was performed (n = 89), an average EF was calculated. As usually recommended, a cut-off value of 50% was used to distinguish the HFPEF from HF with reduced EF.6,19,20

Ischaemic aetiology was assumed in patients with a history of ischaemic heart disease, recent documented history of myocardial infarction or angina pectoris, or coronary artery disease confirmed by coronary angiography.2 The diagnosis of hypertension was established in the presence of one of the following criteria: high blood pressure during hospitalization (>160/95 mmHg), previous diagnosis of hypertension, or normal blood pressure with ongoing antihypertensive therapy.21 HF as a result of valvular heart disease was identified on the basis of clinical history, physical examination, and echocardiography. Dilated cardiomyopathy, restrictive and obstructive cardiomyopathy, constrictive pericarditis, and other rare aetiologies of HF were diagnosed in a minority of cases. An estimate of glomerular filtration rate on admission was calculated using the simplified Modification of Diet in Renal Disease (MDRD) formula, including age, race, gender, and serum creatinine.22

Medical treatment records were completed at discharge. Prescription of the main therapeutic classes in HF was recorded.

Prognosis
One, 3, and 5 year overall mortality and cardiovascular mortality were determined. Sudden death was classified as cardiovascular death. The vital status at 1, 3, and 5 years was obtained either by a consultation at the general practitioner or the referring cardiologist or by consulting the civil registry. Cause of death was ascertained by hospital records, death certificates, and autopsy records or by contacting the patients’ physician or the referring cardiologist. No patients were lost to follow-up at 3 years. Four patients (0.6%) were lost to follow-up at 5 years.

Statistical analysis
Continuous variables were expressed as mean ± standard deviation and were compared between groups by Student's t-test. Categorical variables were summarized by frequency per cents and analysed with {chi}2 test. Univariate analyses of overall mortality were performed using log-rank tests for categorical variables and Cox univariate analyses for continuous variables. For multivariable analyses of mortality, we used a predefined Cox proportional hazards model that included covariates considered of potential prognostic impact [age, gender, history of hypertension, ischaemic aetiology, diabetes mellitus, chronic obstructive pulmonary disease (COPD), cancer, stroke, hyponatraemia (<135 mEq/L), and low glomerular filtration rate (<80 mL/min per 1.73 m2)]. In a separate multivariable model in patients with HFPEF, anaemia (haemoglobin <12 g/dL) was added as a covariate, as this parameter was available in only 336 patients with HFPEF (91%). The linearity assumption of continuous variables was assessed by plotting the variables against the 5 year survival time, using the Lowess smoothing function and locally weighted least squares. For Cox proportional analysis, we tested the proportionality assumption for each variable in single variable analyses using the test proposed by Grambsch and Therneau,23 with a P-value of <0.10 indicating non-proportionality. Overall survival was estimated by the Kaplan–Meier method. Differences in time-to-death between the groups were analysed using a two-sided log-rank test. Survival rates of patients with preserved EF and patients with reduced EF were compared with the expected survival of persons of the same age and gender in the Somme department (France), respectively. Control data were obtained from Somme life tables for 1999 provided by the French Institute of Statistics (INSEE) and represent the survival of the Somme general population. The relative survival was computed as the ratio of the observed to expected survival (observed number of deaths/expected number of deaths in the general population).

Competing risks analysis is an appropriate technique when a population is under the influence of multiple modes of death. We first analysed cardiovascular death in a Cox proportional hazards multivariable model while patients who died of non-cardiovascular causes were censored (as non-events) at the time of death.24,25 Then, after censoring cardiovascular deaths, non-cardiovascular death was looked at in a separate Cox multivariable model. Hazard ratios (HRs) and 95% confidence intervals (95% CIs) for the preserved EF and reduced EF groups were estimated for each mode of death (cardiovascular and non-cardiovascular). Plots of cumulative hazard functions were used for cardiovascular death. A significance level of 0.05 was assumed for all statistical tests. All P-values are results of two-tailed tests. Data were analysed using SPSS 13.0 (SPSS Inc., Chicago, IL, USA) and Stata 9.2 (StataCorp., College Station, TX, USA) statistical software, after approval by the CNIL (French computers and privacy commission).


   Results
Top
 Abstract
 Introduction
 Methods
 Results
Discussion
 Conclusions
 References
 
Patient characteristics
A total of 662 patients (356 males and 306 females) aged 74 ± 12 years (range: 25–100 years) were prospectively included. The sex ratio was 1.06. Of the total patients, 95% (631 patients) were in New York Heart Association (NYHA) functional class III or IV on admission. Coronary artery disease (37%) and hypertension (34%) were the most common causes of HF.

The EF was ≥50% in more than half of our population (55.6%), representing the HFPEF group. The number of patients with HFPEF increased with age, whereas proportion of reduced EF decreased (Figure 1). Sixty-one per cent of patients aged >75 years had an EF of ≥50%.


Figure 1
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  		Figure 1 Percentage of HF patients with preserved and reduced EF by age group. The proportion of HFPEF patients among patients with HF increases with age

 
Baseline characteristics of patients with preserved EF and with systolic dysfunction are displayed in Table 1. The population with preserved EF was significantly older and comprised a larger proportion of women. Systolic blood pressure at admission was significantly higher in patients with HFPEF than in the reduced EF group (153 ± 31 vs. 142 ± 30 mmHg; P < 0.001). Diastolic blood pressure was comparable (P = 0.54). Heart rate at admission was significantly higher in patients with reduced EF (99 ± 26 vs. 91 ± 27 min–1; P < 0.001).


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  		Table 1 Baseline characteristics, aetiologies, and treatment on discharge according to left ventricular ejection fraction

 
A hypertensive or valvular aetiology of HF was more frequent in the preserved EF group. Patients with reduced EF more often had ischaemic heart disease (Table 1). Co-morbidities were not significantly different between the preserved and the reduced EF groups except for peripheral artery disease which was more frequent in patients with reduced EF. The mean number of co-morbidities (stroke, peripheral artery disease, cancer, renal failure, COPD, and diabetes mellitus) per patient in the HFPEF group was 1.23 (1.6 for ischaemic aetiology, 1.22 for hypertensive aetiology, and 1.02 for valvular aetiology).

Treatment prescribed at discharge is detailed in Table 2. ACE inhibitors, aldosterone receptor antagonists, loop diuretics, and digoxin were prescribed significantly less frequently in patients with HFPEF. The preserved EF group had a higher prescription rate of calcium-channel blockers.


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  		Table 2 Medical treatment on discharge according to left ventricular ejection fraction

 
Prognosis and predictors of 5 year mortality for heart failure with preserved ejection fraction
During the 5 year follow-up, 370 patients (56%) died. Survival rates at 1, 3, and 5 years for the preserved EF group were 78, 58, and 43%, respectively, compared with 74, 57, and 46%, respectively, for the population with reduced EF (P = 0.94, Figure 2). On univariate Cox analysis, HFPEF was not associated with lower risk of death (HR, 1.01; 95% CI, 0.82–1.24; P = 0.94). After adjustment to factors of prognostic impact, on multivariable analysis, HFPEF was still not associated with a better 5 year outcome (HR, 1.09; 95% CI, 0.88–1.36; P = 0.41).


Figure 2
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  		Figure 2 Observed and expected survival for patients with HF and preserved or reduced EF. Note that the 5 year overall survival is comparable in patients with preserved or reduced EF (P = 0.94). There is an impressive difference between the survival of patients with preserved or reduced EF and the expected survival for each group

 
Compared with the expected survival, the 1, 3, and 5 year survivals of patients with HFPEF were dramatically lower (78 vs. 94%, 58 vs. 83%, and 43 vs. 72%, respectively) as for patients in the reduced EF group (74 vs. 95%, 57 vs. 84%, and 46 vs. 74%, respectively) (Figure 2). Relative survival of patients in the preserved EF group, expressed as percentage of expected survival, was 83% at 1 year, 70% at 3 years, and 60% at 5 years, whereas the reduced EF group had a relative survival of 78% at 1 year, 67% at 3 years, and 62% at 5 years. Therefore, the 5 year relative survival was comparable between the two groups.

Cardiovascular causes were responsible for 59% of deaths in the HFPEF group. On multivariable Cox analysis, the risk of cardiovascular death in patients with preserved EF was not significantly different from that of patients with reduced EF (HR, 1.15; 95% CI, 0.87–1.53; P = 0.32; Figure 3). The risk of non-cardiovascular mortality was also comparable between the two groups (HR, 1.06; 95% CI, 0.69–1.61; P = 0.81).


Figure 3
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  		Figure 3 Cumulative hazard functions plots for cardiovascular death in patients with preserved and reduced EF

 
Covariates significantly associated with a poor prognosis on univariate analysis in the preserved EF group were: older age, atrial fibrillation on admission, history of myocardial infarction, co-morbidities (diabetes, stroke, peripheral artery disease, and cancer), hyponatraemia, low glomerular filtration rate, and anaemia (Table 3). On multivariable analysis, older age, stroke, COPD, diabetes, cancer, hyponatraemia, and low glomerular filtration rate were identified as independent predictors of mortality in patients with preserved EF (Table 4). The same predictors were identified in the subgroup of patients with HFPEF in whom haemoglobin was available (n = 336, 91%). Anaemia was not an independent predictor of death in this subgroup (HR, 0.98; 95% CI, 0.87–1.12; P = 0.84). In the reduced EF group, older age, low glomerular filtration rate, ischaemic aetiology of HF, and COPD were independent predictors of mortality (Table 4). Five year overall mortality in HFPEF of valvular, hypertensive, and ischaemic aetiology was comparable (Figure 4).


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  		Table 3 Predictors of 5 year mortality on univariate analysis in patients with heart failure with preserved ejection fraction

 

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  		Table 4 Predictors of 5-year mortality in patients with HFPEF and patients with HF and reduced EF—results of Cox multivariable analyses

 

Figure 4
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  		Figure 4 Survival curves by aetiology of HFPEF. Five-year survival was comparable in ischaemic, hypertensive, and valvular aetiologies (39, 41, and 51%, respectively; P = 0.12 for valvular vs. ischaemic aetiology; P = 0.16 for valvular vs. hypertensive aetiology; P = 0.73 for ischaemic vs. hypertensive; overall P = 0.29)

 
Patients in whom EF was not evaluated (n = 137) were older (82 ± 10 years), mostly women (57%) and had a poor prognosis, with a 5 year survival of 17%, significantly lower than that of the 662 patients with an EF assessment during the index hospitalization (P < 0.001).


   Discussion
Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
Conclusions
 References
 
We prospectively studied a cohort of consecutive patients admitted for the first time with a diagnosis of HF in one of the 11 hospital facilities in the Somme department (France), including small and large community hospitals, as well as a university teaching hospital during the year 2000. The profile of this population does not correspond to the highly selected profile of therapeutic trials on HF, including mostly younger male patients. Fifty-six per cent of our patients had preserved EF. Our results portend a severe prognosis for patients with HFPEF in terms of overall mortality, with a 5 year survival of only 43%, dramatically lower than the 72% expected survival rate. Moreover, the prognosis of patients with HFPEF and of those with reduced EF was similar and a similar excess mortality compared with expected survival was observed in the two groups.

Characteristics of heart failure with preserved ejection fraction
Previous studies have reported a proportion of HFPEF among patients with HF widely varying from 13 to 74%.1 The different study populations and differences in study design and diagnostic criteria used for HF in general and HFPEF in particular11–13 are probably responsible for these discordant epidemiological data. A recent retrospective community study conducted in patients hospitalized for HF over a period of 15 years showed an increase over time in the average prevalence of HFPEF compared with HF with reduced EF,20 which could be one explanation for the variable proportion of patients with HFPEF in various studies. Studies including younger patients show a lower frequency of HFPEF.4,7 In the series reported by Senni et al.,2 the EF evaluated in 137 of 216 patients (63%) was normal in 43% of cases. In the Framingham study, 51% of patients had preserved EF. Nevertheless, this figure was based on the analysis of only 73 patients in whom echocardiography was performed.6 Among 269 elderly patients with HF in the Cardiovascular Health Study, EF was normal in 63%.26 In our hospital-based study, the proportion of HFPEF among HF patients was high: 55.6% in the entire cohort, in accordance with figures reported in recent studies.20,27

The present study shows that the proportion of patients with HFPEF increases considerably with age (Figure 1). Our population was relatively old, and had a high representation of women (48%). In accordance with previous studies, women are well represented among patients with preserved EF, as the most frequent aetiology in this setting is hypertension.2,5,28 Patients with preserved EF had more frequently a hypertensive or valvular aetiology and a lower frequency of coronary artery disease.

Prognosis of heart failure with preservedejection fraction
The reported mortality in patients with HFPEF varies considerably. The annual mortality rate for HFPEF ranges from 1.3 to 24%.2,4,6–9,29 In the selected patients of the CHARM-Preserved trial, the annual death rate was only 5.4%, much lower than the annual mortality rates reported in population-based studies.30 Some studies reported that patients with HFPEF and patients with reduced EF have comparable mortality.2,9–12 These apparently inconsistent data result from differences in study populations, HF diagnostic criteria, and the presence or absence of ischaemic or valvular heart disease. Studies including younger patients4,29 reported a lower mortality rate.

In our study, the 1, 3, and 5 year mortality rates in patients admitted for a first episode of HFPEF were high, of 22, 42, and 57%, respectively. These data are in accordance with recent studies, reporting 1 year mortality for HFPEF patients between 19 and 29%.15,16,20 Multivariable analysis identified older age, stroke, COPD, diabetes, cancer, hyponatraemia, and low glomerular filtration rate as predictors of 5 year mortality in the preserved EF group. In a recent study including hospitalized patients with new-onset HF, 1 year predictors of mortality in patients with preserved EF were age, systolic blood pressure, hyponatraemia, anaemia, renal dysfunction, and co-morbidities.15

The present study demonstrates a similar survival for HF patients with preserved EF and reduced EF. Our findings are in accordance with a recent report showing comparable 1 year mortality rates in patients with preserved EF and patients with reduced EF.15 The 5 year cardiovascular mortality of patients with HFPEF in our study is similar to that observed in the reduced EF group. This is an important finding, suggesting that patients with HFPEF die mostly of cardiovascular causes. Thus, the comparable 5 year mortality in the HFPEF and reduced EF groups does not appear to be related to an excess of non-cardiovascular mortality in patients with preserved EF. As medical treatment at discharge was less intensive in patients with HFPEF, we presume that more aggressive cardiovascular therapeutic strategies in this group might have had a significant impact on outcome. Although, in the current study, the 5 year mortality appeared comparable for different aetiologies of HFPEF, HFPEF is certainly a heterogeneous clinical entity. Our belief is that larger studies are needed to better define the long-term prognosis of subsets of patients with HFPEF according to aetiology.31

The control population allowed us to quantify and compare differences between the reduced and the preserved EF groups. There was an impressive difference between the 5 year survival of the group with preserved EF and the expected survival, confirming a dramatic excess mortality. Relative survival rates were similar for patients with preserved and reduced EF.

Limitations
Echocardiography during the index hospitalization was not systematically performed during the first hours after the patient's arrival, as in all epidemiological studies of this type.6 The LV function evaluation was performed in 83% of patients, an acceptable figure compared with large cohort studies in which EF assessment was performed in 42–76% of cases.15,20,28 Diagnosis of HFPEF was based on the analysis of EF, which must be ≥50%. In line with recent recommendations, we adopted this cut-off value in our study.2,6,20 Because setting a definite cut-off for EF may be artificial, some authors15 excluded patients with HF and borderline EF (40–50%). Our study did not include all patients with HF, as less symptomatic patients are not always admitted to hospital, and are sometimes managed at home. However, restricting the analysis to patients hospitalized for a first episode of HF presumably resulted in a more homogenous study population. Our patients were enrolled from community hospitals, private clinics, and a university hospital in the Somme department, which should eliminate the referral bias of hospital-based studies conducted exclusively in tertiary centres. Relative survival was used to compare outcome in the two study groups. This approach has probably some limitations as the disease of interest has a low prevalence in the general population and a reduced impact upon overall population survival. The use of cause-specific hazards of death for competing risk analysis is difficult and has some limitations as plots of cause-specific hazards in the failure probability scale may not always have a probability interpretation in a population under the influence of multiple causes of death. In our study we recorded the frequency of atrial fibrillation on the admission ECG. Therefore, we did not provide the true frequency of atrial fibrillation, as patients with recurrent atrial fibrillation might have been is sinus rhythm at admission. The high frequency of atrial fibrillation in our study (33.5%) could explain the relatively high use of amiodarone.


   Conclusions
Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 Conclusions
References
 
Heart failure with preserved ejection fraction becomes the most common form of HF, representing slightly more than half of all cases of HF in our study. Its frequency increases dramatically with age, underscoring the importance of this growing public health problem. Our study indicates that the prognosis of patients with HFPEF is poor, and just as severe as in patients with reduced EF. Thus, both conditions have a severe prognosis with 5 year mortality rates of almost 60%. Further treatment trials in HFPEF are needed in order to identify beneficial therapies for this frequent condition and improve its prognosis.

Funding
This study was funded by a grant from the French Ministry of Health.


   Acknowledgments
 
Conflict of interest: none declared.


   References
Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 Conclusions
 References
 

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