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European Journal of Heart Failure 2008 10(8):786-792; doi:10.1016/j.ejheart.2008.06.005
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© 2008 European Society of Cardiology

Independence of restrictive filling pattern and LV ejection fraction with mortality in heart failure: An individual patient meta-analysis

Meta-analysis Research Group in Echocardiography (MeRGE) Heart Failure Collaborators*


   Abstract
Top
 Notes
 Abstract
1. Introduction
 2. Methods
 3. Results
 4. Discussion
 References
 
Background: The Doppler echocardiographic restrictive mitral filling pattern (RFP) is an important prognostic indicator in patients with heart failure (HF), but the interaction between RFP, left ventricular ejection fraction (LVEF) and filling pattern remains uncertain.

Aims: To determine whether the RFP is predictive of mortality independently of LVEF in patients with HF.

Methods: Online databases were searched to identify studies assessing the relationship between prognosis and LV filling pattern in patients with HF. Individual patient data from 18 studies (3540 patients) were extracted and collated at the MeRGE Coordinating Centre (The University of Auckland).

Results: Overall, RFP was associated with higher all-cause mortality than the non-restrictive filling pattern: hazard ratio 2.42 (95% CI 2.06, 2.83). In multivariable analysis the RFP, LVEF, NYHA class and age were independent predictors of mortality. The prevalence of the RFP was inversely related to LVEF but remained a predictor of mortality even in those patients with preserved LVEF.

Conclusions: The restrictive mitral filling pattern is a powerful predictor of mortality, independent of LVEF and age, in patients with HF. Doppler-derived LV filling patterns are an accessible marker from echocardiography that can readily be incorporated in risk stratification of all patients with HF.

Key Words: Restrictive filling pattern • Doppler echocardiography • Heart failure • Prognosis • LV ejection fraction

Received April 15, 2008; Accepted June 10, 2008


   1. Introduction
Top
 Notes
 Abstract
 1. Introduction
2. Methods
 3. Results
 4. Discussion
 References
 
Congestive heart failure is a major clinical condition with increasing prevalence, annual mortality rates often exceeding 20% even after institution of contemporary treatment, and more than one million hospitalisations each year [1]. The total cost of heart failure in the United States in 2006 was estimated at US$29.6 billion [1]. However, the clinical course of individual patients with heart failure is highly variable and better understanding of the clinical, laboratory and echocardiographic factors that are associated with poor clinical outcome is important.

Pulsed wave Doppler echocardiography of left ventricular (LV) filling is now widely accepted as a reliable clinical tool in the non-invasive evaluation of diastolic function [2]. With severe diastolic impairment a restrictive filling pattern (RFP) may develop, characterized by left ventricular inflow predominantly occurring in early diastole with a large mitral E wave, rapid deceleration and reduced atrial contribution to filling (mitral A wave). This is associated with elevated left atrial pressures [3-9], increased LV stiffness [10], higher neurohormone levels [11,12], and higher NYHA class [13]. In a recent literature-based meta-analysis, involving 3024 patients with heart failure from 26 prospective studies the unadjusted odds ratio of a RFP for all-cause mortality was 4.36 (CI: 3.60, 5.29) [14].

Many patients with RFP also have concomitant severe LV systolic impairment and although in some studies RFP remained a prognostic predictor in multivariable analyses, none of the individual studies possessed sufficient power to adequately assess the interaction between RFP and systolic function. Thus, it remains uncertain whether RFP merely reflects poor systolic function or predicts outcome independently of LV systolic function. The aim of this individual patient meta-analysis was to determine whether the RFP was predictive of mortality independently of LV ejection fraction (EF).


   2. Methods
Top
 Notes
 Abstract
 1. Introduction
 2. Methods
3. Results
 4. Discussion
 References
 
2.1. Study selection and data collection
This study was designed as an individual patient meta-analysis of observational data and as such followed the MOOSE convention for study selection, collation of data and analysis [15]. The detailed protocol for selection of the relevant studies, data management and analysis has been described in detail elsewhere [16]. In brief, to be eligible, studies needed to be prospective, enrol patients with a confirmed diagnosis of heart failure, and include Doppler echocardiographic diastolic measurements, a measure of systolic function and mortality outcome. Thirty two such studies were identified, 14 studies were not included because the data were inaccessible [16], thus 18 studies (16 published, 2 unpublished) involving 3540 patients (79% of potentially eligible patients) were included in this analysis [9,17-32]. All studies met appropriate clinical definitions of heart failure at the time the studies were conducted. Individual study databases were collated (MeRGE Coordinating Centre, The University of Auckland), variables identified, measurements verified and comparison with individual reports made. Diagnostic criteria for heart failure were clearly stated in all studies. Studies that enrolled patients on the basis of LV dysfunction only without a diagnosis of heart failure were excluded. Patients with permanent atrial fibrillation were excluded from the analysis. The host Ethics Committee approved each original study.

All-cause mortality at four years was the primary end-point of the study. Eleven studies reported all-cause mortality and 7 studies reported cardiovascular mortality (for the purposes of these analyses these deaths were treated as all-cause mortality).

Pulse wave Doppler echocardiography was performed on all patients according to standard protocols for each study. The restrictive mitral filling pattern classification was either that provided from each individual study (based on E:A ratio and deceleration time) or when it was not provided (6 studies) the cut-off of deceleration time <140 ms was used. Patients were thus classified as either having a RFP or having a non-restrictive filling pattern (non-RFP). The aetiology of heart failure (ischaemic or non-ischaemic) was determined from the classification of aetiology from each individual study. LVEF was assessed in 17 studies using quantitative echocardiography (14 studies using volumetric methods [9,17-24,26,27,29-31], 3 studies M-mode [25,32]) and in 1 study using ventriculography [28].

2.2. Analysis
Multivariable analysis to investigate independent predictors of all-cause mortality was performed using the Cox proportional hazards model. Information on LVEF, age, gender, NYHA class and the presence of a RFP was provided by all studies in this analysis and so formed the group of predictors. In order for relevant hazard ratios to be calculated, age was categorised into 10-year bands (<50, 50-60, 60-70 and ≥70 years), LVEF categorised into 10% bands (<20, 20-30, 30-40, 40-50 and ≥50%) and NYHA class was categorised into two bands (NYHA I/II and NYHA III/IV). The assumption of proportionality of hazards for RFP was assessed using Schoenfeld residuals and considered acceptable (plot available on request). Heterogeneity across the studies was examined using the same multivariable model within each study. Univariate hazard ratios were used to investigate the association between RFP and all-cause mortality. The influence of the RFP on survival was analyzed with the Kaplan-Meier method and assessed with the log-rank test. The group was then divided into (a) three pre-specified groups on the basis of LVEF (LVEF <30%, 30-44%, ≥45%) [33] and (b) two pre-specified groups based on the aetiology of heart failure and the same dichotomous comparison was made within each group. Procedures of SAS v 9.1 (SAS Institute, Cary, NC) were employed. A p value <0.05 was considered significant.


   3. Results
Top
 Notes
 Abstract
 1. Introduction
 2. Methods
 3. Results
4. Discussion
 References
 
Data were available for 3540 patients from 18 studies, 421 patients were excluded from this analysis due to the presence of atrial fibrillation (172), or missing data for RFP classification (177) or missing follow up (27). The mean age of the group was 62 years (SD 13 years), 78% were men and mean LVEF was 29% (SD 10.8%) (Table 1). At baseline a RFP was found in 1174 (38%) of the patients and a non-RFP in the remaining 1945 (62%). The median duration of follow up was 1.7 years.


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  		Table 1 Characteristics of patients

 
There were 620 deaths over 5818 person-years of follow up. Among patients with a non-RFP, 266 (13.7%) died compared with 354 (30.2%) patients with a RFP (hazard ratio 2.42; 95% CI 2.06, 2.83; p<0.0001) (Fig. 1). In multivariable analysis RFP, LVEF, NYHA and age were independent predictors of mortality (Table 2). Examination of the multivariable hazard ratio of RFP for each study revealed no heterogeneity across the studies (Chi2=14.5, p=0.63, I2=0%).


Figure 01
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  		Fig. 1 Kaplan-Meier survival curves for patients with heart failure with restrictive filling pattern versus non-restrictive filling pattern.

 


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  		Table 2 Multivariable predictors of all-cause mortality among all patients

 
The prevalence of the RFP was inversely related to LVEF occurring in 50% of patients with LVEF <30%, in 26% of those with LVEF 30-44% and in 14% of those with LVEF ≥45% (Table 1). Similarly mortality was inversely related to LVEF occurring in 26% (431/1642) of those with LVEF <30%, in 14% (169/1231) of those with LVEF 30-44% and in 8% (20/246) of those with preserved LVEF (≥45%). The RFP was associated with higher mortality compared with the non-RFP group in each triad of LVEF (Fig. 2): LVEF group <30% hazard ratio 2.04 (95% CI 1.68, 2.48), LVEF 30-44% hazard ratio 2.45 (95% CI 1.81, 3.32), LVEF ≥45% hazard ratio 3.35 (95% CI 1.33, 8.45).


Figure 02
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  		Fig. 2 Kaplan-Meier survival curves for patients with heart failure with restrictive filling pattern versus non-restrictive filling pattern by group of LV ejection fraction.

 
The aetiology of heart failure was clearly defined in 2869 patients: 1616 (56.3%) patients were classified as ischaemic heart disease and 1253 (43.7%) as non-ischaemic heart disease (Table 3). The prevalence of RFP was similar in patients with ischaemic and non-ischaemic heart disease (37.9% and 37.6% respectively). Mortality was similar in patients with ischaemic and non-ischaemic heart disease (335 deaths, 20.7% versus 240 deaths, 19.2%) and this similarity was irrespective of RFP (p=0.30). However, a RFP was associated with higher mortality in both groups: 32% versus 14% in patients with ischaemic heart disease, hazard ratio 2.41 (95% CI 1.94, 3.00); and 29% versus 13% in those with non-ischaemic heart disease, hazard ratio 2.57 (95% CI 1.99, 3.32) (Fig. 3).


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  		Table 3 Characteristics of patients with ischaemic and non-ischaemic heart disease

 


Figure 03
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  		Fig. 3 Kaplan-Meier survival curves for patients with heart failure with restrictive filling pattern versus non-restrictive filling pattern by aetiology of heart failure.

 
Multivariable analyses in both aetiology sub-groups revealed similar results as the main study, with RFP, LVEF, NYHA and age independent predictors in both ischaemic and non-ischaemic HF patients (Table 2).


   4. Discussion
Top
 Notes
 Abstract
 1. Introduction
 2. Methods
 3. Results
 4. Discussion
References
 
In this individual patient meta-analysis, involving over 3000 patients with heart failure and 620 events, the RFP is associated with a 2-fold increase in the risk of death. Importantly, this is the first time that the relationship of the RFP and survival has been demonstrated to be independent of LVEF and age and applies for patients with heart failure of ischaemic and non-ischaemic aetiology.

The RFP is associated with high left atrial pressure [3-9], neurohormonal activation [11,12], and higher NYHA class [13]. However, the unique contribution of this large study is that the relationship between restrictive filling and outcome is independent of LVEF. While previous studies have demonstrated that the RFP is a poor prognostic sign in patients with depressed LVEF it has been uncertain whether the RFP was merely a reflection of more severe LV systolic dysfunction. In the current study, while the prevalence of the RFP was higher among those patients with lower LVEF, the data confirm that this filling pattern is associated with worse outcome independently of LVEF.

Heart failure is the end stage of many common conditions including hypertension and coronary artery disease. Despite aggressive pharmacological intervention, cardiac resynchronisation therapy and antiarrhythmic device implantation in appropriate patients mortality for patients with heart failure remains high [34,35]. Multiple demographic, clinical, laboratory and echocardiographic variables have been associated with outcome in these patients. Assessment of prognosis is now incorporated into contemporary heart failure management guidelines [36], although it is recognized that this is often complex and that the optimal methods of estimating prognosis are uncertain. Echocardiography is widely available and commonly utilised in the evaluation of patients with heart failure. However the focus is often directed towards indices of LV systolic function and LV diastolic function is often not reported [37]. Newer tissue Doppler echocardiographic techniques combined with transmitral velocities may provide independent prediction of clinical outcomes over transmitral Doppler alone in patients with LVEF <35% [30]. However, the RFP is readily identified from echocardiography, is associated with 2-fold higher mortality across a broad range of patients with heart failure and is thus an accessible and clinically useful marker of prognosis. Consequently, this simple prognostic marker can readily be made available to clinicians managing patients with heart failure without the requirement for additional investigations.

Approximately 30-50% of patients with heart failure present with preserved LVEF [38,39]. Patients with heart failure with preserved LVEF are more likely to be older, to be female and to have a history of hypertension and atrial fibrillation compared with patients with impaired LVEF [38,39]. In addition, the prevalence of heart failure with preserved LVEF appears to have increased over recent decades [39]. As such, heart failure with preserved LVEF is an important clinical condition and yet there has been little evidence to guide treatment among such patients. Recent clinical trials involving patients with heart failure with preserved LVEF have not demonstrated improved survival with ACE inhibitor therapy [40,41]. In the current study, 246 patients had LVEF≥45%, and when compared with the patients with LVEF<45% were older, more were women and fewer were classified as having heart failure of ischaemic aetiology. Thus, while a small sample, these patients have characteristics similar to those previously described in other studies [38,39] and although mortality in this group of patients with preserved LVEF was relatively low (8%) the mortality in patients with RFP was high (21% versus 6%).

Ideally, markers of outcome should not only allow assessment of prognosis but also trigger changes in management to improve outcome. Currently, there are no randomised, controlled trials of therapeutic interventions directed specifically at patients with the RFP. Data from non-randomised studies have reported improved outcome for patients with RFP who were treated with conventional pharmacotherapy (including ACE inhibitors, beta-blockers and diuretics) [29,42]. These data suggest that further studies should be undertaken with therapies targeted at patients with RFP, and the group of patients with heart failure with preserved LVEF may be an ideal group for such studies.

4.1. Limitations
Each of the studies from which the individual patient data were combined had slightly different inclusion criteria, for example, some recruited patients during a hospitalisation with an exacerbation of heart failure while others included patients attending an outpatient visit. As a result the echocardiograms from which the filling pattern classification was derived were not performed at a standardised stage of disease or after a certain period of treatment. While this is an inherent limitation of these data this does support the value of the RFP across a range of patients with heart failure and at different stages of the disease process.

The number of patients with preserved LVEF (>45%) was small (n=246) with a smaller number of events (20), compared to the patients with impaired LVEF (<45%). Thus, while the hazard ratio for RFP predicting death was statistically significant, the confidence intervals were wide and thus the magnitude of the risk associated with the RFP remains uncertain. In addition, detailed clinical characteristics of this group of patients with LVEF >45% were not available from these data. Patients with atrial fibrillation were excluded from this meta-analysis and thus the prognostic importance of restrictive filling in patients with atrial fibrillation is uncertain. The present result may be subjected to publication bias; studies with a positive result are more likely to be published with a risk of overestimating the true effect of a RFP. In addition, a number of published studies are not included (approximately 21% of all published data). However, despite these factors, the different inclusion criteria and major temporal changes in the management of heart failure, the risk associated with a RFP was strikingly consistent. Furthermore, we did not detect significant heterogeneity in the importance of a RFP across the 18 studies included in the meta-analysis.

4.2. Conclusions
In summary, in patients with heart failure the Doppler echocardiographic RFP is associated with a 2-fold increase in the risk of death and is independent of LVEF, NYHA class and age. The RFP is an accessible marker from routine echocardiography that provides additional information to LVEF alone and thus should be incorporated into the risk stratification of all patients with heart failure, irrespective of the degree of LV systolic dysfunction.


   Acknowledgements
 
MeRGE Collaboration:

MeRGE coordinating centre: Cardiovascular Research Laboratory, The University of Auckland, New Zealand: RN Doughty (co-principal investigator), GD Gamble (statistician), KK Poppe (statistician), JB Somaratne, GA Whalley (co-principal investigator).

Writing committee: RN Doughty (co-chair), AL Klein (co-chair), KK Poppe, GD Gamble, FL Dini, JE Møller, M Quintana, CM Yu and GA Whalley.

MeRGE steering committee members: FL Dini (Santa Chiara Hospital, Pisa, Italy), RN Doughty (Co-chair, The University of Auckland, New Zealand), GD Gamble (The University of Auckland, New Zealand), AL Klein (The Cleveland Clinic Foundation, Ohio, USA), JE Møller (Copehagen University Hospital Rigshospitalet, Denmark), M Quintana (Huddinge University Hospital, Karolinska Institute, Sweden), GA Whalley (Co-chair, The University of Auckland, New Zealand) and CM Yu (Prince of Wales Hospital, The Chinese University of Hong Kong, China).MeRGE Heart Failure Collaborators:

Principal collaborators:

MeRGE steering committee plus C Bruch (Germany), M Feola (Italy), S Ghio (Italy), P Giannuzzi (Italy), A Hansen (Germany), J Ortiz (Brazil), B Pinamonti (Italy), DL Prior (Australia), A Rossi (Italy), J-Y Tabet (France), PL Temporelli (Italy) and T Yamamoto (Japan).

Studies included:

Australia: St Vincent's Hospital, Melbourne: DL Prior*; Brazil: OMNI-CCNI Medicina Diagnóstica, São Paulo: J Ortiz*, CG Monaco, CES Silva, LDC Ferreira, MA Gil, NC Nanda, CAF Monaco; China: The Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong: JE Sanderson, CM Yu*; France: Hôpital Beaujon, Clichy: A Cohen-Solal, M Dahan, PV Ennezat, C Geyer, C Guiti, D Logeart, J-Y Tabet*; Germany: University Hospital of Münster, Münster: G Breithardt, C Bruch*, L Eckardt, M Gotzmann, M Grude, M Rothenburger, HH Scheld, J Stypmann, F Wenzelburger, T Wichter; University of Heidelberg, Heidelberg: M Haass, A Hansen*, C Krueger, W Kuebler, H Kuecherer, K Unnebrink, R Zimmermann, C Zugck; Italy: Salvatore Maugeri Foundation, Veruno: E Bosimini, U Corrà, M Galli, P Giannuzzi*, A Giordano, A Imparato, F Scapellato, P Silva, PL Temporelli*; Istituto di Ricovero e Cura a Carattere Scientifico Policlinico S Matteo, Pavia: N Ajmone-Marsan, C Campana, A Gavazzi, S Ghio*, C Klersy, ML Laudisa, F Recusani, R Sebastiani, L Tavazzi; Villamarina Hospital, Piombino, Campo di Marte Hospital, Lucca: U Baldini, A Boni, L Barsotti, L Cortigiani, FL Dini*, G Micheli R Nuti; Division of Cardiology, University of Verona, Verona: A Rossi*, M Cicoira, S Bonapace; University of Trieste, Trieste: F Camerini, A Di Lenarda, D Gregori, B Pinamonti*, G Sinagra, M Zecchin; Ospedale S. Croce-Carle, Cuneo & Ospedale Santo Spirito, Rome & San Dona' di Piave: N Aspromonte, M Feola*, P Giovinazzo, L Milani, R Valle; Japan: University of Tokushima, National Higashi Tokushima Hospital, Tokushima: T Ishimoto, S Ito, T Oki, T Tabata, H Tanaka, T Wakatsuki, H Yamada, T Yamamoto*; New Zealand: The University of Auckland, Auckland: RN Doughty*, GD Gamble, HJ Walsh, N Sharpe, GA Whalley*, SP Wright; USA: The Cleveland Clinic Foundation, Ohio: A Fogarty, CM Frampton, AL Klein*, MS Lauer, M Martin, AJ Morehead, PJ Nash, JJ Pereira, DL Prior, RC Starling, W Tang, JD Thomas, R Troughton, JB Young; Multi-centre clinical trials: Australia-New Zealand Heart Failure Research Collaborative Group: RN Doughty*, GD Gamble, S MacMahon, DN Sharpe, GA Whalley*.

*Indicates principal collaborator.

Funding

This research was funded by grants from The University of Auckland Vice-Chancellor’s Development Fund and from the National Heart Foundation of New Zealand.


   Notes
Top
 Notes
Abstract
 1. Introduction
 2. Methods
 3. Results
 4. Discussion
 References
 
* R.N. Doughty, Department of Medicine, The University of Auckland, Private Bag 92019, Auckland, New Zealand. Tel.: +64 9 373 7599x89804; fax: +64 9 3677146. E-mail address: r.doughty{at}auckland.ac.nz Back


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

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 Eur J Heart FailHome page
A. Rossi, P. L. Temporelli, M. Quintana, F. L. Dini, S. Ghio, G. S. Hillis, A. L. Klein, N. Ajmone Marsan, D. L. Prior, C. M. Yu, et al.
Independent relationship of left atrial size and mortality in patients with heart failure: an individual patient meta-analysis of longitudinal data (MeRGE Heart Failure)
Eur J Heart Fail, October 1, 2009; 11(10): 929 - 936.
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