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European Journal of Heart Failure 2007 9(9):935-941; doi:10.1016/j.ejheart.2007.06.001
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© 2007 European Society of Cardiology

Ejection fraction and blood pressure are important and interactive predictors of 4-week mortality in severe acute heart failure

Chris Adamopoulosa, Faiez Zannadb,*, Renaud Faya, Alexandre Mebazaac, Alain Cohen-Solald, Louis Guizee, Yves Juillièreb and François Allaf

a Clinical Investigation Center of Nancy France
b Department of Cardiology, University Hospital of Nancy France
c Department of Anesthesiology and Critical Care Medecine Hôpital Lariboisère, Paris, France
d Department of Cardiology, Beaujon Hospital France
e Department of Cardiology, University Hospital of Paris-Descartes France
f Department of Epidemiology, University Hospital of Nancy France

* Corresponding author. Centre d'Investigation Clinique (CIC) INSERM-CHU, Hopital Jeanne d'Arc, 54200 Dommartin les Toul, France. Tel.: +33 383 65 66 25; fax: +33 383 65 66 19. E-mail address: f.zannad{at}chu-nancy.fr


   Abstract
Top
 Abstract
1. Introduction
 2. Methods
 3. Results
 4. Discussion
 5. Conclusions
 References
 
Background: In acute heart failure syndromes (AHFS), the prognostic value of left ventricular ejection fraction (LVEF), although widely accepted, has been recently challenged. In contrast, blood pressure is increasingly gaining ground over LVEF as predictor of mortality. Therefore, it is not clear whether both LVEF and mean arterial pressure (MAP) are independent risk factors in patients with AHFS.

Methods and results: The EFICA study enrolled 581 AHFS patients admitted to 60 CCU/ICUs. Survival at 4 weeks was analyzed for all cases with echocardiographic LVEF available on admission (n%355).

Four-week mortality was 23%. Multivariable analysis identified lower LVEF, lower MAP and serum creatinine >1.5 mg/dl as independent correlates of mortality (respectively, OR: 1.27 per 10% decrease, CI: 1.05–1.53, p%0.012; OR: 1.30 per 10 mmHg decrease, CI: 1.15–1.48, p<0.0001; OR: 2.84, CI: 1.64–4.93, p%0.0002).

LVEF interacted significantly with MAP (p<0.0001) and the subgroup analysis showed that reduced LVEF was a strong risk factor in patients with MAP ≤90 mmHg (OR: 2.73, CI: 1.23–5.98, p%0.01) but did not reach statistical significance in patients with MAP >90 mmHg.

Conclusions: Both LVEF and MAP are important predictors of death in severe AHFS. LVEF can provide additional prognostic information on top of MAP but mainly in patients with low MAP (≤90 mmHg) at admission.

Key Words: Acute heart failure • Ejection fraction • Mean arterial pressure • Critical care

Received October 23, 2006; Revised April 2, 2007; Accepted June 4, 2007


   1. Introduction
Top
 Abstract
 1. Introduction
2. Methods
 3. Results
 4. Discussion
 5. Conclusions
 References
 
The term acute heart failure syndromes (AHFS) encompasses a broad spectrum of heterogeneous clinical syndromes and confers high in-hospital mortality. Mortality rate is even higher (>25% at 4 weeks) in AHFS patients with life threatening symptoms, requiring intensive care treatment [1,2].

Although the different components of blood pressure (mean, systolic or pulse) have been almost invariably reported to be strong mortality predictors in heart failure [3-6], the prognostic significance of LVEF in this setting is less clear. The perception that the survival rate among patients with most forms of heart failure is inversely related to LVEF, at least for LVEF below 45% [7-12], has been challenged by recent evidence suggesting that heart failure patients with preserved LVEF may have approximately the same mortality with those with systolic heart failure [13-15]. Additionally, in predictive models derived by recent, large-scale, community-based AHFS registries, LVEF is no longer included as a significant prognostic factor, whereas blood pressure is constantly present [4-6].

Moreover, LVEF and MAP have never been assessed together as prognostic factors in high-risk patients with AHFS, admitted to critical care units.

The French EFICA study (Etude Française de l'Insuffisance Cardiaque Aiguë) included unselected, high-risk patients with severe AHFS, admitted to ICU. Acute phase (4 week) mortality was 27% [16].

In this analysis, we aimed to assess the prognostic value of LVEF and MAP, both basic haemodynamic determinants, on short-term mortality in the EFICA study patients. We also tested the hypothesis that LVEF and MAP may interact in terms of prognosis, suggesting that the prognostic significance of LVEF may be different according to the level of MAP.


   2. Methods
Top
 Abstract
 1. Introduction
 2. Methods
3. Results
 4. Discussion
 5. Conclusions
 References
 
2.1. Patients: The EFICA Study
The design, baseline findings and primary results of the EFICA study have been reported in detail [16]. Briefly, the EFICA study was a 1-year observational, follow-up study of patients with severe forms of AHFS, admitted to 60 French ICU/CCUs, between April and October 2001. Participating units enrolled 581 consecutive patients aged ≥18 years, with signs and/or symptoms of AHFS according to the opinion of the attending investigator. Patients admitted directly to a general ward were excluded in order to ensure selection of cases with severe forms of AHFS.

Since AHFS in the setting of acute myocardial infarction has a unique pathophysiology and has been extensively investigated in recent observational and interventional studies [17], this category was not considered in the EFICA study.

2.2. Data collection and assessment of ejection fraction
Data were collected by the investigators using a structured Case Record Form (CRF). Baseline characteristics, as well as the results of the clinical examination, ECG, X-ray, echocardiography and laboratory tests were collected upon admission to the ICU/CCU. Data on therapeutic measures applied during hospitalization were collected from medical records upon discharge. All CRFs were reviewed for AHFS diagnosis by a steering committee composed of five senior cardiologists, two senior intensive care specialists and three epidemiologists. Adjudication was based on a consensus between the steering committee members. If an agreement was not reached, cases were classified as "unknown".

LVEF was measured as part of a full echocardiographic assessment. LVEF was quantified according to the method routinely used in the centre, there was no central standardization. Of the 573 patients with complete records, this analysis includes the 355 (62%) patients in whom echocardiographic LVEF data was available.

2.3. Statistical analysis
Data from the EFICA database were used for retrospective analyses, based on the availability of LVEF. Continuous variables are described as means±SD and categorical variables as frequencies and percentages. Univariate comparisons between different groups were performed using Student's t-test and chi-square test, for continuous and categorical variables respectively.

To identify the independent predictors of all-cause mortality during the 4-week follow-up period a stepwise regression analysis was carried out for the entire echocardiographic cohort. The following candidate predictors of mortality which can be easily and objectively assessed in the initial hours of ICU/CCU presentation were included in the analysis: LVEF, MAP, age, sex, heart rate, serum creatinine >1.5 mg/dl, atrial fibrillation, ventricular tachycardia, LBBB, raised myocardial injury marker(s), NYHA class, previous ischaemic heart disease, prior AMI, previous hospitalizations for AHFS, previous PCI and/or CABG, peripheral vascular disease, COPD, history of hypertension and diabetes. Numerical variables were tested as continuous variables except for serum creatinine and myocardial injury marker(s) in order to investigate a practical and clinically relevant threshold effect of these parameters. LVEF and MAP were tested as both continuous and dichotomous variables in separate models. To allow evaluation of LVEF and MAP as dichotomous variables, the cut-off values of 40% and 90 mmHg (median MAP) were used to characterize LVEF and MAP status respectively.

In the current analysis, we used MAP instead of systolic pressure (SAP) because MAP has been found to have an inverse correlation with adverse outcomes in heart failure [3] and constitutes the principal component of blood pressure used in haemodynamic calculations; it is entirely determined by cardiac output and peripheral resistance and is not influenced by large-artery stiffness, a common problem encountered with SAP measurements especially in the elderly [18].

Both forward and backward stepping was used to protect against the omission of important predictors. For the variables included in the final model, all pair-wise interactions were tested. We report odd ratios (OR) and corresponding 95% confidence intervals (CI). The Hosmer-Lemeshow test and the area under the receiver-operator curve were used to assess the goodness-of-fit and the discrimination of the models, respectively.

To further investigate the prognostic interaction between LVEF and MAP, the echocardiographic cohort was then divided in two groups, based on the median value of the mean arterial pressure (90 mmHg), and separate logistic regression analysis was carried out for the subgroups.

Statistical analysis was performed with SAS software 8.2. For all tests, a p value <0.05 was considered statistically significant.


   3. Results
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
4. Discussion
 5. Conclusions
 References
 
3.1. Patient characteristics
Of the 573 AHFS patients included in EFICA study who had complete records [16], 355 (62%) patients had an echocardiographic LVEF measurement performed on admission (echocardiographic cohort) and are therefore included in this report. Demographics, past medical history, clinical data on admission, major in-hospital interventions and outcome for patients with and for those without LVEF measurements are shown in Tables 1 and 2. In the echocardiographic cohort, the mean age was 72±13 years, 61% of subjects were male and 31% were classified as being in NYHA classes III-IV prior to admission; the mean MAP was 92±25 mmHg [median MAP=90 mmHg] and MAP was normally distributed. Mean LVEF was 38±16% and 33% of patients had an LVEF >40%. Nearly half of the patients received inotropic support and invasive mechanical ventilation was used in one-third of the subjects.


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  		Table 1 Demographics and past medical history

 


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  		Table 2 Admission data, in-hospital care and outcome

 
There were significant differences between the echocardiographic cohort and the group of patients in whom LVEF was not measured. The latter group presented more frequently with signs of shock and received significantly more inotropes and mechanical ventilation. Descriptive data regarding this group reflect an apparent higher risk profile than the echocardiographic cohort. These data are shown in the tables but are not the focus of this manuscript.

3.2. Factors predictive of 4-week mortality in the echocardiographic cohort
At 4 weeks, the mortality rate among patients with in-hospital assessment of LVEF (echocardiographic cohort) was 23%, which was not substantially different from the mortality for the entire EFICA cohort (27%) [16]. The multivariate analysis identified LVEF, MAP and serum creatinine >1.5 mg/dl as significant, independent predictors of 4-week mortality with a 27% increment for each 10% decrement in baseline LVEF and 30% increment for each 10 mmHg decrement in baseline MAP. ORs and 95% CIs are reported in Table 3. When analyzed as dichotomous variables both LVEF ≤40% and MAP ≤90 mmHg along with creatinine >1.5 mg/dl remained strong mortality predictors (Table 3). The Hosmer-Lemeshow test was not significant (p=0.55) and the area under the receiver-operator curve was 0.78, indicating that the final model, despite its parsimony, provides an adequate fit and a high degree of discrimination.


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  		Table 3 Multivariate models of 4-week mortality

 
LVEF, MAP and serum creatinine >1.5 mg/dl retained their independent prognostic significance even after adjustment for use of inotropes and invasive mechanical ventilation (OR: 1.32 CI: 1.08-1.61, OR: 1.16 CI: 1.01-1.32, OR: 2.60 CI: 1.44-4.69, for LVEF, MAP and creatinine, respectively).

Among pair-wise interactions tested for the final model, only LVEF interacted significantly with MAP (p<0.0001), suggesting that LVEF does not have the same prognostic importance in patients with different MAPs. Before further exploring the interaction between LVEF and MAP, differences between patients with a MAP above or below the median value (90 mmHg) were analyzed in the echocardiographic cohort (Tables 1 and 2). A MAP below 90 mmHg was associated with higher rates of abnormal creatinine on admission and more frequent use of inotropic support and invasive mechanical ventilation. Mean LVEF on admission was somewhat different between patients with MAP ≤90 mmHg and those with MAP >90 mmHg (36±16 vs. 41±16%, p=0.003), and a sizeable portion of patients with an LVEF >40% was detected in each group (28 vs.39%, p=0.022) (Fig. 1). There were no other significant baseline differences between those with MAP above and below the median value of 90 mmHg, apart from relatively higher rates of previous AHFS hospitalizations and higher prevalence of NYHA III-IV class for the patients in the lower MAP range.


Figure 01
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  		Fig. 1 Distribution of LVEF status (>40% or ≤40%) by MAP class on admission.

 
Subsequently, a multivariate analysis was run separately for patients with MAP above or below 90 mmHg. This subgroup analysis showed that an LVEF ≤40% was an independent prognostic factor of adverse outcome in the subgroup with lower MAP (OR: 2.73; CI: 1.23-5.98, p=0.01) but did not retain its independent prognostic role in patients with MAP >90 mmHg (OR: 1.49; CI: 0.49-4.49, p=NS). The results of this subgroup analysis are schematically represented by the survival curves at 4 weeks (Fig. 2): LVEF status clearly defines higher and lower risk patients in the group with MAP ≤90 mmHg but this difference is much less important for patients with MAP >90 mmHg.


Figure 02
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  		Fig. 2 Kaplan-Meier survival curves at 4 weeks, according to LVEF status and MAP class on admission.

 

   4. Discussion
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
 4. Discussion
5. Conclusions
 References
 
The present data show that the basic and readily measurable parameters LVEF, MAP and serum creatinine are important predictors of mortality in patients with severe AHFS, requiring admission to intensive care units.

Low blood pressure and renal impairment have previously been identified as mortality predictors and our results are consistent with data from randomized heart failure studies and registries [1-6]. Our finding that low LVEF is related to increased mortality is not unexpected, as the inverse relationship between LVEF and mortality has been repeatedly confirmed by several reports [7-12]. Nevertheless, the prognostic value of LVEF has recently been questioned by studies and meta-analyses that have reported no significant effect of baseline LVEF on mortality [13-15]. In the same line of evidence, LVEF has not been included as prognostic factor in predictive models and algorithms derived from recent large-scale AHFS registries [4-6]. Differences in populations, divergent cut-off values for LVEF and different methods of analysis may account for this discrepancy and make comparisons between these studies difficult [19]. Comparison with our data is more difficult as we recruited patients at the highest end of the severity scale, with the highest mortality ever reported.

Senni and Redfield [14] concluded that studies showing an inverse relationship between mortality and LVEF were often biased by exclusion of older patients and patients with preserved systolic function, and by lack of standardized therapeutic protocols. Age-related bias was not present in the current study, as the mean age was 72±13 years, which is comparable to AHFS studies in general. In addition, we also included a substantial number of patients with relatively preserved systolic function (33%). To help circumvent some of the limitations induced by non-standardized treatment protocols in our centres, we adjusted our model by entering mechanical ventilation and use of inotropes as covariates. These interventions, apart from being possibly harmful per se [20], may also denote more severe disease. Even in this case, both LVEF and MAP remained strong predictors of death. Finally, further adjustment of our models for the presence of signs of shock did not materially alter our results for LVEF and MAP.

Our finding that both LVEF and MAP are important predictors of 4-week mortality can be explained pathophysiologically. Although LVEF is an important index of ejected volume, it must be remembered that the heart generates pressure as well as flow and the pressure generating ability of the heart has also been shown to have prognostic value in heart failure [21,22]. In the same context, it has been demonstrated that coupling blood pressure measures to LVEF added prognostic power to LVEF [23,24]. Our results suggest that this issue is also important in cases of severely compromised haemodynamics.

The prognostic interaction between LVEF and MAP, however, is more complex. We observed that, although mortality was largely driven by LVEF in patients with lower MAP (41%vs.22%), the mortality differences according to LVEF status were much less pronounced in those with higher MAP (11%vs.9%). This observation was confirmed by the multivariate analysis, although based on fewer events in the higher MAP subset. To our knowledge, such a finding has not been reported by previous studies and may afford an additional explanation for the discrepancies about the prognostic role of LVEF. Its physiological background is not entirely clear, but some assumptions can be made. The acute heart failure process is characterized by both, recruitment of contractile reserve and peripheral vasoconstriction [25]. Thus, a patient with adequate MAP has already established an adequate peripheral perfusion and hence a less decompensated state, either by means of a preserved LVEF or by an appropriate peripheral vascular adaptation. In contrast, in a patient with low MAP, perfusion is jeopardized and in this case a preserved LVEF is a crucial index of contractile reserve: it indicates the tolerance of the heart to higher degrees of peripheral vasoconstriction, necessary for establishing adequate tissue perfusion.

Another possible explanation for this finding is that LVEF, although a reasonable measure of systolic function is a poor measure of diastolic dysfunction. Patients who have heart failure have diastolic dysfunction, regardless of ejection fraction, which is also a strong predictor of adverse outcome [26]. Measures of diastolic dysfunction are thus likely to prevail prognostically over LVEF in certain groups of heart failure patients, especially those with higher blood pressure.

An important observation in our study was that one-third of our patients had an LVEF >40%. This high prevalence of patients with an LVEF >40%, although in line with many recent AHFS registries [11,27-29], is still surprising if we take into consideration that we only included patients in the most acute condition, with mortality rates far higher than in other studies. Furthermore, a sizeable portion of LVEF >40% was found among the sickest subgroup of our subjects, ie those with MAP ≤90 mmHg (28%). This demonstrates that even life threatening forms of AHFS may be accompanied by relatively preserved LVEF and emphasizes that haemodynamics are more complex than a simple measurement of LVEF [30].

4.1. Strengths and limitations
This analysis is strengthened by its unique population of unselected patients with AHFS and life-threatening symptoms, requiring rapid intervention. It included both systolic and non-systolic aetiologies, at the highest end of the spectrum of severity, and hence the reported results reflect a "realistic" situation for managing this severe clinical condition. Finally, central adjudication was performed for clinical data and echocardiographic LVEF was available on admission in a large subset of patients despite the extremely acute clinical situation.

The study limitations are related to the strengths. The study was uncontrolled and observational in nature.

We acknowledge that LVEF assessment was not standardized, but on the other hand, similar assessments are used to make clinical decisions in everyday practice.

We also recognize that information about systolic function is missing in a considerable fraction of the study population and this may have resulted in selection bias; several other studies have shown variation in the rates of assessment of LVEF [4,11,27,28]. In the current study (and similar to other observational studies), patients without an estimate of LVEF had a higher risk profile and a worse prognosis. However, our finding, that LVEF is prominently predictive in the subgroup with lower blood pressure and hence higher risk, is relatively reassuring in this respect.

It must be also acknowledged that the small absolute number of deaths in patients with MAP >90 mmHg may limit the power of our subgroup analysis for this subset of patients.

Brain natriuretic peptide (BNP) measurements were not widely used at the time of the EFICA study and data were only available for a minority of patients in our analysis. Therefore, the independent role of BNP could not be assessed in this study.

Finally, our conclusions apply to patients with severe AHFS, managed in the critical care setting and should not be extrapolated to the general population of patients hospitalized for heart failure.


   5. Conclusions
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
 4. Discussion
 5. Conclusions
References
 
This analysis from the EFICA database shows that LVEF and MAP are powerful and potentially interactive predictors of short-term mortality in this high-risk population. Due to this interaction however, LVEF was less prognostically contributive in patients with normal or high MAP than in those with low MAP. A considerable proportion of our patients had an LVEF >40%, demonstrating that acute heart failure even with relatively preserved systolic function can be severe enough to require intensive care interventions.

Given the high in-hospital mortality of AHFS patients admitted to intensive care, our conclusions may facilitate more accurate risk stratification for an appropriately stepped approach to care.


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

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