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European Journal of Heart Failure Advance Access originally published online on August 4, 2009
European Journal of Heart Failure 2009 11(9):855-862; doi:10.1093/eurjhf/hfp103
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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.

The prognostic significance of heart failure with preserved left ventricular ejection fraction: a literature-based meta-analysis

Jithendra B. Somaratne1, Colin Berry2, John J.V. McMurray3, Katrina K. Poppe1, Robert N. Doughty1 and Gillian A. Whalley1,*

1 Department of Medicine, Faculty of Medicine and Health Sciences, The University of Auckland, Private Bag 92019, Auckland Mail Centre, Auckland 1142, New Zealand
2 The University of Glasgow, Glasgow, UK
3 The Western Infirmary, Glasgow, UK

* Corresponding author. Tel:+64 9 923 9813, Fax: +64 9 367 7146, Email: g.whalley{at}auckland.ac.nz


   Abstract
Top
 Abstract
Introduction
 Methods
 Results
 Discussion
 Conclusions
 Funding
 References
 
Aims: Heart failure (HF) with normal or preserved left ventricular (LV) ejection fraction (HFPEF) has been reported to be associated with similar outcome as HF with reduced EF (HFREF) in registry-based and epidemiological analyses, but many of these studies excluded patients who did not have EF measurements. Conversely, prior prospective studies have reported better outcome for patients with HFPEF. We performed a meta-analysis of prospective observational studies comparing all-cause mortality in patients with HFREF and HFPEF.

Methods and results: We searched several online databases for studies comparing outcome in HFREF and HFPEF, published before 2007. Inclusion criteria: prospective, clinical HF, near complete EF data, and mortality outcome. Review Manager version 4.2.3 software was used for the analysis. Overall, 24 501 patients [9299 deaths (38%)] from 17 studies are included. Average follow-up was 47 months; the HFPEF group was older (69 vs. 66 years) and more likely to be female (44% vs. 26%). Of the 7688 patients with HFPEF 2468 died (32.1%), compared with 6831 of the 16 813 patients with HFREF (40.6%): odds ratio 0.51 (95% CI: 0.48, 0.55).

Conclusion: This literature-based meta-analysis demonstrates that mortality among patients with HFPEF was half that observed in those with HFREF, in contrast to previous reports suggesting that mortality may be similar between both groups.

Key Words: Meta-analysis • Heart failure • Mortality • Preserved ejection fraction

Received May 21, 2009; Revised June 24, 2009; Accepted June 24, 2009


   Introduction
Top
 Abstract
 Introduction
Methods
 Results
 Discussion
 Conclusions
 Funding
 References
 
Heart failure (HF) is a clinical syndrome characterized by dyspnoea, oedema, and limitation of functional capacity, it is caused by a cardiac abnormality1 and has traditionally been thought to result from impaired left ventricular (LV) contractility. A reduced LV ejection fraction (EF) has been widely used to define systolic dysfunction, assess prognosis and select patients for therapeutic interventions. However, it is recognized that HF can occur in the presence of preserved EF (HFPEF) which may be found in up to 50% of all patients with HF.2

Patients with HFPEF are more likely to be older, female and have a history of hypertension and less likely to have an ischaemic aetiology compared with patients with HF with reduced EF (HFREF).3,4 Though they experience similar symptoms and exhibit similar signs, patients with HFPEF tend to have less functional limitation, as assessed by the New York Heart Association classification. In contrast to HFREF, no treatment has been shown to improve outcome in patients with HFPEF.2

Although recent registry-based4 and epidemiological studies5,6 have reported similar outcomes for patients with HFPEF compared with HFREF, the prognosis of patients with HFPEF compared with those with HFREF is uncertain. We hypothesize that some studies may have been subject to important bias by not including all patients and not requiring an accurate assessment of EF in all patients. To overcome these limitations, we undertook a meta-analysis of prospective studies in which measurements of EF were systematically available, in order to compare all-cause mortality in patients with HFREF and HFPEF.


   Methods
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 Abstract
 Introduction
 Methods
Results
 Discussion
 Conclusions
 Funding
 References
 
We followed the MOOSE guidelines for performing a meta-analysis of observational data.7

Selection of prospective studies
For inclusion, studies were required to: (i) have a prospective study design (i.e. patients were identified and data collected at the point at which follow-up began, not when it was completed); (ii) measure EF in all included patients (within reasonable limits); (iii) distinguish patients according to type of HF (i.e. HFREF and HFPEF); and (iv) report all-cause mortality by type of HF. Although randomized controlled trials do not recruit consecutive patients, they do in general fulfil the other inclusion requirements and thus were included. There was no limitation on the method of EF measurement or a specific EF cut-off for the definition of HFPEF. Any study that used LV size (e.g. cardiothoracic ratio on chest radiograph) or systolic function as inclusion or exclusion criteria were excluded.

Comparison studies
We identified a number of studies that did not fulfil the above criteria, and these data were pooled in a similar fashion to the prospective studies in order to provide a comparative group. This group of ‘comparison studies’ included studies where EF was not consistently available, but where other inclusion criteria were largely met.

Search strategy
The study hypothesis and protocol for identification of studies were developed by all investigators, and the initial literature search was carried out using the key words: heart failure, left ventricle, prognosis, outcome, and preserved. The time period for the search was from the inception of the searched databases to 31 December 2006. Several online databases were electronically searched and hand searching of reference lists of obtained articles and previously identified reviews was carried out. Abstracts, unpublished studies and articles published in languages other than English were not excluded. Authors of included studies confirmed data extraction and were invited to provide details of any additional studies, unpublished data and ongoing trials.

The titles and abstracts of all studies identified from the search of online databases were initially screened by one investigator (C.B.). Any studies which clearly did not meet the selection criteria were discarded. The abstracts of the remaining studies were then screened by two investigators (G.A.W. and J.B.S.) and were retained if either investigator thought they were relevant. The full-text of all potentially relevant studies was obtained. Disagreement between the two investigators was resolved by the adjudication of a third investigator (K.K.P.). Excluded studies that fulfilled other inclusion criteria were collated separately for purposes of comparison.

Data extraction
Data were extracted from included studies and recorded in an electronic database, including: definition of HFPEF, measure of EF, duration of follow-up, number of patients and deaths in the HFREF and HFPEF groups, mean age, gender, and proportion with ischaemic cardiomyopathy. The corresponding or senior authors of all included studies were contacted by email, asked to verify the extracted data and provide any missing data. In the case of potential duplicate publications, the largest single published data set was used for the literature-based meta-analysis (LMA.).

Statistical analyses
The principal measure of effect used in this analysis was odds ratio (OR) with 95% confidence intervals calculated under the fixed effects model using the Mantel–Haenszel method, using The Cochrane Collaboration Review Manager (version 4.2.3) software. Heterogeneity between included studies was examined by: visual assessment of forest plots for spread of effect estimates and overlap of confidence intervals; Cochran's Q-test for heterogeneity with a significance level set at P< 0.05; and calculation of the I2 statistic. An I2 statistic of greater than 50% was considered substantial heterogeneity. Funnel plots were examined for asymmetry to assess publication bias.

Study flow
The total number of potentially relevant articles identified was 6244: 5644 articles from the online database search and 60 from authors' reference libraries and hand searching of reference lists. Of these, 5868 were discarded after initial screening, abstracts of the remaining 376 articles were printed and screened for retrieval. Of these, 240 studies failed to meet the meta-analysis inclusion criteria and were therefore excluded. The full-text papers of the remaining 136 studies were retrieved for more detailed evaluation, after which, a further 113 studies were excluded, leaving 23 potentially appropriate studies to be included in the meta-analysis. Six of these failed further scrutiny, leaving 17 studies eligible for inclusion (Figure 1).


Figure 1
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  		Figure 1 Study flow diagram.

 

   Results
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 Abstract
 Introduction
 Methods
 Results
Discussion
 Conclusions
 Funding
 References
 
Prospective studies
This meta-analysis included 17 studies8–24 of HF patients yielding a total of 24 501 patients of whom 9299 patients died (38%) during a pooled mean follow-up of 47 months (range 6–84) (Table 1). The pooled mean age of patients included was 67 years, 68% were male and 58% had HF of ischaemic aetiology (Table 2). The definition of HFPEF varied between studies from an EF >40–55% or fractional shortening >24–25%. The most common EF cut-offs were 45% (five studies), 40% (four studies), and 50% (three studies). Left ventricular systolic function was assessed by echocardiography (16 studies), X-ray contrast ventriculography (four studies), and radionuclide ventriculography (six studies). There was no evidence of important publication bias on funnel plot examination.


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  		Table 1 Table of included prospective studies

 


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  		Table 2 Patient characteristics

 
Overall, there were 2468 deaths among the 7688 patients with HFPEF compared with 6831 deaths among the 16 813 patients with HFREF. As such, patients with HFPEF had an OR for all-cause death of 0.51 (95% CI: 0.48, 0.55) compared with those with HFREF (Figure 2). Overall, there was no evidence of heterogeneity between included studies ({chi}2 = 24.62, P = 0.08, I2=35.0%) (Figure 2). A sensitivity analysis excluding patients from the three large trials15–17 contributing the majority of patients to this meta-analysis (weight 83%) demonstrated a similar result with an OR of 0.56 (95% CI 0.48, 0.66). The OR for all-cause death in the three large randomized controlled trials alone was similar with confidence intervals overlapping the OR from the other studies (OR 0.51, 95% CI: 0.47, 0.54; Figure 2).


Figure 2
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  		Figure 2 Forest plot of included prospective studies. n/N = number of deaths/number at risk.

 
Comparison studies
There were a total of 30 511 patients in 22 comparison studies5,6,25–44 which met other selection criteria. In this comparison group of studies, there were 11 081 deaths (36%) during a pooled mean follow-up of 32 months (range 3–74) (Table 3). The pooled mean age of patients was 69 years, 60% were male and 50% had an ischaemic aetiology (Table 2). The proportion of patients excluded from these studies on the basis of missing EF measurement was 40% with a range of 4–70% (Table 3).


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  		Table 3 Table of comparison studies

 
Overall, there were 4758 deaths in 13 845 patients with HFPEF and 6323 deaths in 16 666 patients with HFREF. This yielded an OR for all-cause death in the patients with HFPEF of 0.74 (95% CI: 0.70, 0.78) compared with those with HFREF (Figure 3). In this analysis, however, there was significant heterogeneity between studies ({chi}2=144.49, P < 0.00001, I2 = 85.5%). There was variation across these studies, for example, the prevalence of HFPEF within the studies ranged from 14 to 66% and the percentage of patients with missing EF data varied from 4 to 70%. This heterogeneity and the results of the pooled data from the prospective studies support the concept that these studies are different to the prospective studies.


Figure 3
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  		Figure 3 Forest plot of excluded comparison studies n/N = number of deaths/number at risk.

 

   Discussion
Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
Conclusions
 Funding
 References
 
The growing burden of HF has been recognized over recent years. During this time, numerous studies have focused on therapies aimed at improving outcomes and quality of life in patients with HFREF. Recent data suggest that this effort resulted in an improvement in survival in patients with HFREF between 1987 and 2001.5,45,46 However, during the same period, the prevalence of HFPEF has continued to rise and outcomes in these patients have not changed significantly.5 Despite a number of trials now reporting outcome for patients with HFPEF, individual studies have produced conflicting results. Two large community-based studies,5,6 recently reported that mortality was similar among patients with HFREF and HFPEF, leading to renewed concerns regarding patients with HFPEF. The current meta-analysis, which included 24 501 patients and 9299 deaths, from 17 studies in which EF measurements were available for all patients, demonstrates that patients with HFPEF had half the odds of death compared with patients with HFREF.

Given the powerful relationship between EF and outcome in HF (albeit among patients with impaired EF), it is intuitive that patients with HFPEF should have a better prognosis and our findings support this view. There are several potential sources of bias that may have affected the results from previous individual studies. Ideally, all patients included in such studies should have undergone an accurate assessment of EF (as EF was the single criterion upon which patients were assigned to the HFREF and HFPEF groups). If the proportion of patients with missing EF measurements was small and had occurred randomly in both groups, the impact on outcome should not be of major consequence. However, in practice, it is known that EF is measured less frequently among some groups of patients, such as elderly patients with HF.47 Furthermore, patients in whom an EF measurement is missing are known to experience different outcomes compared with those in whom EF is measured.26 As patients with HFPEF are older and more likely to be female, there is a high likelihood of systematic selection bias when comparing patients with HFREF to those with HFPEF, if patients are excluded due to missing EF measurements.

The results from the current meta-analysis are in stark contrast with two large retrospective studies5,6 which concluded that patients with HF experienced similar outcome regardless of whether they had preserved of impaired EF. In both studies, however, measurements of EF were missing in a significant number of patients (up to 70%). These concerns are highlighted by the disparity between the patient characteristics in the retrospective and prospective clustering of studies used in our meta-analysis. We collated data from 22 comparison studies, which met all other inclusion criteria, except for having EF measurements in most patients. In addition to the missing EF measurements, there were other notable differences in patient characteristics. Patients in the prospective studies were younger (67 vs.69 years), more likely to be male (68% vs.60%), have ischaemic aetiology (58% vs.50%), and have longer follow-up (47 vs.32 months).

One caveat about our findings is that the observed difference in outcome in the prospective studies was driven by a substantial proportion (84%) of patients derived from three large clinical trials, these were: the Candesartan in Heart Failure Assessment of Reduction in Mortality and Morbidity program,15 the Digitalis Investigation Group trial,16 and the Danish Investigators of Arrhythmia and Mortality on Dofetilide trial.17 Clinical trials such as these have inclusion and exclusion criteria, which will invariably exclude certain patients and thus they do not represent consecutive recruitment of HF patients at any one study centre; however, despite these limitations, measurement of EF is usually required. Interestingly when the analysis was sub-grouped by randomized controlled trial or observational studies, a similar OR for all-cause death was observed in both sub-groups, suggesting that the inclusion of these trials did not change the general magnitude and direction of the overall OR.

Understanding the impact of a disease process such as HF does have important implications for patient management. Heart failure is a clinical syndrome with a range of underlying structural and functional cardiac abnormalities, this is reflected for example by the wide range of EF values. Further improvements relating to therapy may only arise if we clearly understand the outcome for all patients with HF.

Limitations
Literature-based meta-analyses have inherent limitations, including publication bias, duplication of data, and the inability to assess the independent impact of possible confounding factors. To minimize publication bias, we contacted all corresponding authors of included studies and asked for any unpublished data. There was no evidence of publication bias on visual examination of the funnel plot. Duplication of patients in this meta-analysis is unlikely given the rigorous methodology adopted: this included extensive consultation and confirmation of published data with the corresponding authors of included studies. Although there was no significant statistical heterogeneity (differences in the reported effects) between studies included in this meta-analysis, there were sources of methodological (differences in study design) and clinical (differences between studies in characteristics of participants, interventions, or outcome measures) heterogeneity.


   Conclusions
Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 Conclusions
Funding
 References
 
In this LMA of prospective studies, mortality among patients with HFPEF was half that observed in those with HFREF. These data are in contrast to recent reports suggesting that mortality may be similar in these groups. The comparison studies are limited due to a high proportion (40% on average) of patients excluded from the analyses due to missing EF data; in contrast, the prospective studies are limited by the potential for selection bias as many of the patients were enrolled in clinical trials. Further research, either an individual patient data meta-analysis or large prospective clinical study, is required to better understand this prevalent and clinically important condition.


   Funding
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 Abstract
 Introduction
 Methods
 Results
 Discussion
 Conclusions
 Funding
References
 
This study was not supported by any external grants, although several authors were individually supported through research fellowships and awards: J.B.S. was the recipient of the Douglas Goodfellow Medical Research Fellowship from the Auckland Medical Research Foundation; C.B. was supported by a British Heart Foundation International Fellowship; G.A.W. was the recipient of a National Heart Foundation of New Zealand Senior Fellowship; and K.K.P. is supported by a National Heart Foundation of New Zealand Post-graduate Scholarship.

Conflict of interest: none declared.


   Acknowledgements
 
The authors gratefully acknowledge the assistance of Kanchana Perera who assisted with data verification and the following authors who confirmed their published data or provided additional data for use in this publication: A. Ahmed (USA), B. Andersson (Sweden), G.M. Felker (USA), J.K. Ghali (USA), M. Guazzi (Italy), J.R.G. Juanatey (Spain), L. Køber (Denmark), M. Komajda (France), H. Krumholz (USA), M.J. Lenzen (Netherlands), S.M. Macin (Argentina), B.K. Madsen (Finland), M. Martinez-Selles (Spain), B.M. Massie (USA), F.A. McAlister (Canada), M.M. McDermott (USA), R. Pai (California, USA), M. Redfield (USA), G.L. Smith (USA), I. Squire (UK), G.E. Taffet (USA), L. Tarantini (Italy), K. Teo (Canada), and Y. Wang (USA).


   References
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 Methods
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 Discussion
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 Funding
 References
 

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