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European Journal of Heart Failure 2007 9(5):502-509; doi:10.1016/j.ejheart.2006.10.021
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© 2006 European Society of Cardiology

Atrial fibrillation in heart failure patients: Prevalence in daily practice and effect on the severity of symptoms. Data from the ALPHA study registry

Gaetano M. De Ferraria, Catherine Klersyb, Paolo Ferreroc, Cecilia Fantonid, Diego Salerno-Uriartee, Lorenzo Mancaf, Paolo Devecchig, Giulio Molonh, Miriam Reveraa, Antonio Curnisi, Simona Sarzi Bragaj, Francesco Accardik, Jorge A. Salerno-Uriarted,* and ALPHA Study Group1

a Department of Cardiology, Fondazione IRCCS Policlinico San Matteo Pavia, Italy
b Service of Biometry and Clinical Epidemiology, Fondazione IRCCS Policlinico San Matteo Pavia, Italy
c University of Torino, San G. Battista Hospital Torino, Italy
d University of Insubria, Circolo Hospital and Macchi Foundation Varese, Italy
e University of Insubria, Clinical Institute Mater Domini Castellanza (VA), Italy
f F. Ferrari Hospital, Casarano (LE) Italy
g University of Piemonte Orientale, Maggiore Hospital Novara, Italy
h Sacro Cuore Hospital, Negrar (VR) Italy
i University of Brescia, Spedali Civili Hospital Brescia, Italy
j IRCCS S. Maugeri Foundation, Scientific Institute, Tradate (VA) Italy
k Guidant Italia Milano, Italy

* Corresponding author. Cardiological Sciences Department, University of Insubria, Medical School of Varese, Ospedale di Circolo e Fondazione Macchi, Viale Borri, 57, 21100 Varese, Italy. Tel.: +39 332 278 934; fax: +39 332 393 309. E-mail addresses: jorge.salerno{at}ospedale.varese.itjorge.salernouriarte{at}uninsubria.it


   Abstract
Top
 Notes
 Abstract
1. Introduction
 2. Methods
 3. Results
 4. Discussion
 References
 
Background: Estimates of the prevalence of atrial fibrillation (AF) in heart failure (HF) originate from patients enrolled in clinical trials.

Aims: To assess the prevalence and clinical correlates of AF among HF patients in everyday clinical practice from HF patients screened for the T-wave ALternans in Patients with Heart fAilure (ALPHA) study; to investigate the correlation between AF and functional status.

Methods and results: Consecutive patients (N=3513) seen at nine Heart Failure Clinics were studied; 21.4% were in AF. AF prevalence was greater with increasing age (OR 1.04/year, p<0.001) in non-ischaemic cardiomyopathy (OR 2.34, p<0.001) and with increasing NYHA class (p<0.0001). Multiple logistic regression predictors of AF were age >70 years (OR 2.35), NYHA class II III or IV vs class I (OR 1.8, 4.4 and 3.1) and non-ischaemic cardiomyopathy (OR 3.2).

A logistic model indicated that AF was associated with a 2.5 OR of being in NYHA class III–IV vs I–II while accounting for age, gender, left ventricular ejection fraction (LVEF), and aetiology of HF.

Conclusions: The prevalence of AF in HF patients exceeds 20%, and increases with age and functional class. The presence of AF leads to a more severe NYHA class, indicating that AF contributes to the severity of heart failure.

Key Words: Arrhythmia • Atrial flutter • Cardiomyopathy • Epidemiology • Fibrillation • Heart failure

Received March 21, 2006; Revised August 11, 2006; Accepted October 31, 2006


   1. Introduction
Top
 Notes
 Abstract
 1. Introduction
2. Methods
 3. Results
 4. Discussion
 References
 
The prevalence of both chronic heart failure (HF) and of atrial fibrillation (AF) is steadily increasing. Since the two conditions share common risk factors they frequently coexist [1-3]. Among patients with congestive heart failure (CHF), the prevalence of AF increases with increasing severity of the disease ranging from values around 5% found in studies of New York Heart Association (NYHA) class I patients [4], to values approaching 50% in studies enrolling only class IV patients [5] with intermediate values found in studies with class II and III patients [6-10].

Most of these estimates however are derived from clinical treatment trials, which implies that the patients were not representative of normal clinical practice due to the presence of several exclusion criteria.

Therefore, the first goal of the present study was to assess the prevalence and clinical correlates of AF among patients with HF in everyday clinical practice, using a registry of over 3500 consecutive patients with heart failure screened for enrolment in the T-wave ALternans in Patients with Heart fAilure (ALPHA) study [11].

The second goal of the study was to investigate the correlation between the presence of AF and functional status, assessed by NYHA class. At variance with the common opinion that the increased prevalence of AF among patients with higher NYHA class is simply the consequence of an increased disease severity, we tested the hypothesis that the presence of AF could significantly contribute to a more advanced functional class.


   2. Methods
Top
 Notes
 Abstract
 1. Introduction
 2. Methods
3. Results
 4. Discussion
 References
 
2.1. Population of the study
The population of the study corresponds to that of the Registry of the T-wave ALternans in Patients with Heart fAilure (ALPHA) study. The original study was designed to evaluate the independent predictive value of the measurement of T-wave alternans (TWA), on the combined occurrence of cardiac death and life-threatening arrhythmias, in a population of patients with non-ischaemic dilated cardiomyopathy in NYHA class II and III, over an average of 18 months of follow-up.

All consecutive patients seen at the Heart Failure Clinics of nine Italian Hospitals (from April 2001 to July 2004) were screened for eligibility into the ALPHA trial. All screened patients (N=3513) were entered into the ALPHA Registry and constituted the basis of the present analysis.

Table 1 provides details about the main clinical characteristics of the population of the study, overall and according to aetiology of HF. It shows an average age of 67 years (ranging from 14 to 101) and a greater prevalence of men (70%), an average depressed LV ejection fraction of 34±10%, with 23% of patients with preserved LV function (EF 41% or greater); 1219 patients (35%) were in NYHA class III or IV. Heterogeneity between aetiologic groups was present for all characteristics (p<0.001).


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  		Table 1 Characteristics of the ALPHA study population overall and according to the aetiology of heart failure

 
2.2. Statistical analysis
Mean±standard deviation (SD) and counts (%) are reported for description throughout the manuscript. Clinical characteristics were compared according to HF aetiology by means of ANOVA or Chi-square test. Logistic modelling was performed to assess the association of patient characteristics and the presence of AF. To identify independent clinical correlates of AF (goal 1), a multivariate logistic model was fitted, including variables (with p<0.1 at univariate analysis (age (>70 years), EF (<=30%), NYHA class, conduction disturbances and aetiology of heart failure). Colinearity between predictors was excluded. To assess whether AF would predict the likelihood of being classified in a higher NYHA class (goal 2), a generalized ordinal logistic model was fitted (to relax the assumption of proportional odds); the potential confounders were included: age, sex, left ventricular ejection fraction (LVEF) and aetiology of heart failure. Also a logistic model was fitted to assess the role of AF (adjusted for confounders) on the likelihood of being classified in NYHA class III-IV. Interaction was assessed to test the hypothesis of a different role of AF in the categories of the confounders. Odds ratios (OR) and their 95% confidence intervals (95%CI) were computed to measure the strength of the association. A 2-sided p-value <0.05 was considered statistically significant. Stata 8 (StataCorp, College Station, TX) was used for computation.


   3. Results
Top
 Notes
 Abstract
 1. Introduction
 2. Methods
 3. Results
4. Discussion
 References
 
3.1. Clinical correlates of AF
Overall 752 patients from the ALPHA Registry, corresponding to a prevalence of 21.4% (95%CI 20.0%-22.8%) were in AF. Their characteristics are summarized in Table 2. Women were more likely than men (26% vs 19%, p<0.0001) to be in AF. As expected, patients in AF were older and the prevalence of AF increased linearly with age (OR 1.04 per year, p<0.001). When patients were divided by quartiles of age (14-59, 60-68, 69-76, 77-101 years), the prevalence of AF increased from 10% to 19, 25 and 31%, respectively (test for trend p<0.001). Patients over 70 years had a 29% likelihood to be in AF, as compared to a 15% probability among patients aged 70 or less (OR=2.23, p<0.001).


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  		Table 2 Clinical correlates of patients in the ALPHA Registry according to the presence of atrial fibrillation: univariate and multivariate logistic models

 
The prevalence of AF varied markedly (p<0.001) on the basis of the underlying diagnosis. Prevalence of AF was 14% among patients with ischaemic cardiomyopathy, 20% among patients with idiopathic dilated cardiomyopathy, 31% among patients with hypertensive aetiology and 49% among patients with HF of valvular origin. Grouped together, patients with non-ischaemic cardiomyopathy had a 28% prevalence of AF, which was twice that for ischaemic patients (OR 2.34, p<0.001).

Patients in AF had a slightly but significantly higher mean LV ejection fraction compared with patients in sinus rhythm (OR=1.04, p<0.001). Accordingly, the prevalence of AF was slightly greater in the higher LV ejection fraction group both when ejection fraction was dichotomized at >40% vs ≤40% (29% vs 19%, OR=1.67 for EF >40%, p<0.001) and when it was dichotomized at >30% vs ≤30% (23% vs 20% p=0.02).

In agreement with current knowledge, prevalence of AF was found to increase significantly (p<0.0001 test for trend) with increasing NYHA class. It was 10% among patients in class I, and 17%, 32% and 28% among patients in class II, III and IV, respectively. The corresponding OR, relative to NYHA I, were 1.95, 4.44 and 3.64, respectively. The absence of a further increase for class IV, compared with class III patients was unexpected but it may be related to the relatively small proportion of patients in this functional class (6%).

No relationship was found between the presence of AF and QRS duration (QRSd). This was 122±35 ms among patients in AF and 120±34 ms among patients in sinus rhythm (paced patients were excluded from this analysis). Atrial fibrillation was present in 20% of patients with QRSd <120 ms and in 23% of patients with both QRSd of 120-150 ms and >150 ms. On the other hand, at univariate analysis AF was more often present (31% of cases) among the patients (6% of the overall population) who had right bundle branch block (RBBB) as compared with patients with left bundle branch block (LBBB) (19% of cases) or no intraventricular conduction defect (22% of cases, p<0.001). To assess the independent correlates of the presence of AF in the population of the study, a multiple logistic regression analysis was performed. Results are summarized in Table 2. Age >70 years was associated with a more than two-fold increase in the likelihood of AF. Being in NYHA class II compared with class I, conferred a 1.8-fold increase in the risk of having AF, while being in class III and IV increased the likelihood by 4.4 and 3.1-fold, respectively. The presence of non-ischaemic cardiomyopathy was associated with roughly 3-fold the probability of being in AF compared with the remaining diagnoses. The presence of an LV ejection fraction >30% was associated with a nonsignificant 19% increase in the likelihood of AF. Finally patients with LBBB had a 32% reduction in the likelihood of AF, with respect to patients without intraventricular conduction defect. The odds ratio for gender was close to 1, indicating that the greater prevalence of AF among women was mostly due to the older age (71±13 vs 65±12 years, p<0.001) and to the greater proportion of women with non-ischaemic origin of HF (62% vs 51%, p<0.001), two features that are significant independent predictors of AF. If age was entered in the model as a continuous variable, it was found that each year of age increase was associated with a 4.9% increase in the likelihood of AF (95%CI 4.0-5.8, p<0.0001). When restricting the analysis to the more homogeneous population with ischaemic and idiopathic aetiologies (69%), similar results were obtained (data not shown).

3.2. AF and functional class
The correlation between AF and functional class was studied with the goal of assessing the independent influence of the presence of AF. In the overall population, more than half (51%) of the patients in AF were in NYHA class III-IV (hereafter defined as advanced class) as compared with less than one third (30%) of patients in sinus rhythm (p<0.001). Obviously, this does not, per se, suggest that the presence of AF leads to a worse functional class. It may simply be that a more advanced disease or demographics and aetiology lead to both a worse functional class and to a greater likelihood of AF.

To account for this, we evaluated the effect of AF on the likelihood of being in a higher NYHA class, while accounting for age (>/≤70), sex (M/F), LVEF (≤/>30%) and aetiology of HF (non-ischaemic/ischaemic) by means of a generalized ordered logistic model. AF was associated with a two-fold increase in the likelihood of being in class II rather than I (OR 2.27 (95%CI 1.55-3.34), p<0.001) and in class III rather than II (OR 2.49 (95%CI 2.08-2.98), p<0.001) and with a 1.5-fold increase of being in class IV rather than III (OR=1.47 (95%CI 1.06-2.06), p=0.023). In keeping with these findings, the OR for the association of AF with an advanced NYHA class (while adjusting for confounders) was computed to be 2.50 (95%CI 2.08-3.00, p<0.001) by means of logistic regression. In addition we could also confirm a significant (p<0.01) association of each of the potential confounders with both NYHA and advanced NYHA.

Finally we tested the hypothesis of a different strength of association of AF and advanced NYHA within each category of the confounders. A significant interaction was indeed present for LVEF (p=0.020) and aetiology (p<0.001). Twenty percent of patients without AF and 44% with AF had an advanced NYHA class in the LVEF preserved group as compared to 44% and 62%, respectively, in the depressed LVEF group (Fig. 1, left), corresponding to an OR of 3.12 (95%CI 2.49-3.91, p<0.001) and of 2.07 (95%CI 1.59-2.69, p<0.001) for patients EF >30% and EF ≤30%, respectively. Twenty-five percent of patients without AF and 52% with AF had an advanced NYHA class in the non-ischaemic group, as compared to 36% and 50% respectively in the ischaemic group (Fig. 1, right). The corresponding ORs were computed to be 3.21 (95%CI 2.60-3.96, p<0.001) and 1.76 (95%CI 1.33-2.34, p<0.001) in patients with non-ischaemic and ischaemic aetiology, respectively. No interaction was observed between AF and age (p=0.119) and AF and gender (p=0.246), where a common OR could be retained.


Figure 01
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  		Fig. 1 Prevalence of NYHA class I and II (grey bars) or III and IV (advanced NYHA class) (black bars) in different subgroups of patients without (upper panels) or with AF (lower panels).

 
The analysis performed on the subgroups of non-ischaemic and ischaemic patients also revealed, in both instances, a similarly and significantly increased OR for patients in AF to be advanced NYHA class.


   4. Discussion
Top
 Notes
 Abstract
 1. Introduction
 2. Methods
 3. Results
 4. Discussion
References
 
The ALPHA study registry provided an opportunity to have updated information on the clinical epidemiology of over 3500 nonselected patients with HF and, specifically, to obtain a reliable estimate of the prevalence of AF and of its clinical correlates. In a multivariate logistic analysis, patients in a higher NYHA class, older in age, with non-ischaemic aetiology, without LBBB (and marginally patients with higher LVEF) were shown to have a higher likelihood of AF. The study also tested the hypothesis that the presence of AF could significantly contribute to a more advanced functional class.

4.1. Prevalence of AF among patients with heart failure
A complex relationship is present between heart failure and atrial fibrillation. The coexistence of the two conditions is facilitated by the presence of common risk factors, such as age, hypertension, diabetes, valvular and ischaemic heart disease. These factors are associated with neurohormonal activation, myocardial cellular and extracellular alterations and electrophysiological changes that combine to create an environment that predisposes to both heart failure and atrial fibrillation.[12]. In the Framingham Study, HF was the most powerful predictor of atrial fibrillation, with more than fivefold relative risk [13]. The total proportion of HF patients with atrial fibrillation at any time was 41% [14]. Clinical trials enrolling patients with HF have reported a prevalence of AF ranging from 5% to 50% [4,5], and have also shown an increasing prevalence with increasing severity of the disease. The present study provides a reliable estimate of the prevalence of AF in clinical practice, indicating that slightly more than 20% of nonselected HF patients were in atrial fibrillation, confirming the correlation between advanced functional class and greater prevalence of atrial fibrillation. The data also show that AF is more prevalent among HF patients with relatively preserved systolic function. This finding is in good agreement with data originating from a similar database of HF outpatients [15] and with two very recent large studies in patients hospitalised for heart failure [16,17]. We believe this pattern is likely to be related to the greater prevalence of AF among patients with HF due to diastolic dysfunction or more generally of hypertensive and valvular origin.

4.2. Independent role of the presence of AF on functional class
The role of atrial fibrillation in the severity and in the progression of HF is not unequivocal. Potentially unfavourable consequences of AF in this population include: the loss of atrial transport, the impairment of ventricular rate control, the reduction of exercise performance, a tendency towards greater atrial enlargement and an increased embolic risk [1,18].

Despite these theoretical considerations, atrial fibrillation is not generally considered a critical factor in patients with heart failure. This concept originates mainly from the absence, in patients with heart failure, of a clear demonstration of either the independent prognostic value of AF or of a clinical benefit provided by a rhythm control strategy.

Van den Berg et al. [19] reviewed six trials [20-25] that assessed the impact of AF on mortality in patients with heart failure. Three studies used databases from large drug trials [21,23,25] and three studies included patients referred as potential candidates for heart transplant [20,22,24]. All studies were retrospective. The study by Stevenson et al. [22], compared two treatment periods (1985-1989 and 1990-1993) and concluded that AF was a predictor of mortality in the first, but not in the second period. It was suggested that the improvement in drug treatment (ACE inhibitors and amiodarone instead of vasodilators and class I antiarrhythmics) was the main reason for the overall reduction in mortality and the loss of predictive power of AF. Two trials [23,25] found AF to be a univariate predictor of mortality and only one of this [23], a multivariate predictor. This latter study evaluated 6517 patients from the Studies Of Left Ventricular Dysfunction (SOLVD) trial (prevention and treatment arms) and found a multivariate relative risk for all-cause mortality of 1.34 (p=0.002) for AF. In the other studies, AF was not found to be significant predictor of mortality. Preliminary data from Pai et al. [26] obtained in patients undergoing echocardiography suggest an independent predictive value of AF in patients with normal or mildly depressed LV function, but none in those with moderately or severely depressed LV function.

Overall, the review paper concluded that there was a potential prognostic role for AF in patient with mild to moderate HF, but not in patients with severe HF. However, the results of the Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) and the RAte Control versus Electrical cardioversion for persistent atrial fibrillation (RACE) trials, were awaited. These studies subsequently [27,28] found that a rhythm control strategy provided no benefit, and actually showed a trend towards harm [27] in the general population of patients, when compared with a rate control strategy. However, it must be underlined that the subgroup of patients with HF enrolled in the AFFIRM trial showed a trend toward a different behaviour, with a relative risk lying on the side of benefit of rhythm control. This finding leaves open the possibility of a favourable effect of rhythm control in this population of patients. The few papers published to date have failed to show an improvement in left ventricular function and in quality of life in patients with HF and persistent AF in whom restoration and maintenance of sinus rhythm was attempted [2].

We have, however, recently provided data suggesting a significant long-term improvement in both functional class and LV function among advanced HF patients subjected to internal cardioversion and amiodarone treatment [29].

These data suggest that atrial fibrillation can, indeed, have a role in the progression of HF [1]. The present study confirmed the existence of a strong association between increased prevalence of AF and advanced NYHA class. Since these patients have a worse prognosis it appears important to understand whether AF is simply the consequence of the advanced functional class that should thus be considered the sole predictor. Since there is nothing more than the state of the art treatment that can be done to ameliorate functional class, the concept that AF is solely the result of an advanced state of the disease, leads to no specific action for these patients. If, on the other hand, the presence of atrial fibrillation itself leads to a more advanced functional class, a rationale to treat AF in heart failure patients would be appropriate.

4.3. Limitations of the study
A snapshot vision such as the one derived from the present Registry cannot definitively solve this "chicken and egg" question. However, the finding that after accounting for factors known to be associated with functional class such as age and LVEF, the presence of AF is associated with more than two-fold likelihood of being in an advanced NYHA class, strongly suggests that AF may have a role in worsening functional class.

To minimize the number of patients presenting to the clinic and not entered in the screening log we kept the information needed for the log very limited. This has reduced the potential for selection bias but has prevented us from obtaining potentially important information such as history of paroxysmal AF, pharmacological treatment, extent of mitral regurgitation, presence of pulmonary hypertension and left atrial size. Several of these factors may, theoretically, affect both prevalences of AF and functional class. However, we believe that the present data suggest that AF itself may contribute to a higher functional class and that this cause-effect relationship may account for part of the prognostic value of NYHA class in the presence of atrial fibrillation.

4.4. Conclusion
The present study indicates that the prevalence of AF among an unselected population of patients with HF exceeds 20%, ranging from 10% in NYHA class I to 30% in class III and IV. The likelihood of AF increases with increase in age (by 4% for each year) and in functional class. It is more often present in patients with non-ischaemic compared with ischaemic cardiomyopathy and slightly more in patients with relatively preserved LV function compared with patients with depressed LV function. Although it occurs more often in women than in men, this difference is not due to gender, but rather to the older mean age and to the greater prevalence of non-ischaemic disease in women.

The study also indicates that the presence of AF cannot be considered solely the consequence of a more advanced disease, but rather that it leads to a more severe NYHA class, with about a 2-fold likelihood of being in a higher NYHA class in the presence of AF, even when accounting for variables such as age, LV function and aetiology of the disease.

This finding is in agreement with the concept that atrial fibrillation may contribute to the progression of heart failure.

ALPHA Study Group:

Steering Committee: Chairman: JA Salerno-Uriarte; Members: GM De Ferrari, C Klersy, RFE Pedretti, L Sallusti, M Tritto

List of centers and physicians

Principal Centers

Università degli Studi dell’Insubria, Dipartimento di Cardiologia, Istituto Clinico Mater Domini, Castellanza (VA): T. Forzani, M. Tritto, D. Salerno-Uriarte, M. Baravelli, N. Podimani; Università degli Studi di Torino, Divisione Universitaria di Cardiologia, Azienda Ospedaliera San Giovanni Battista, Torino: G.P. Trevi, L. Libero, E. Favro, M. Bobbio, P. Ferrero; Università degli Studi del Piemonte Orientale, I Divisione di Cardiologia, Ospedale Maggiore, Novara: C. Vassanelli, E. Occhetta, P. Devecchi, S. Maffè, V. Conti; Divisione di Cardiologia, IRCCS Fondazione S. Maugeri, Istituto Scientifico, Tradate (VA): R.F.E. Pedretti, S. Sarzi Braga, D. Bertipaglia, R. Vaninetti; Università degli Studi di Brescia, Divisione di Cardiologia, Spedali Civili, Brescia: L. Dei Cas, A. Curnis, G. Mascioli, T. Bordonali, L. Culot; Università degli Studi dell’Insubria, Dipartimento di Scienze Cardiovascolari, Ospedale di Circolo e Fondazione Macchi, Varese: J.A. Salerno-Uriarte, F. Morandi, M. Romano, C. Fantoni, G. Bartesaghi, S. Rogiani, P. Albonico; Divisione di Cardiologia, Ospedale Sacro Cuore, Negrar (VR): E. Barbieri, G. Molon, E. Adamo; Divisione di Cardiologia, Presidio Ospedaliero F. Ferrari, Casarano (LE): G. Pettinati, L. Manca, D. Melissano; Università degli Studi di Pavia, Dipartimento di Cardiologia, Fondazione IRCCS Policlinico San Matteo, Pavia: G.M. De Ferrari, C. Campana, S. Ghio, M. Revera, D. Belloli.

Satellite Centers

Divisione di Cardiologia, Presidio Ospedaliero Galmarini, Tradate (VA): D. Barbieri, L. Amati; Centro Polifunzionale Cardio-Pneumologico, Ospedale Chiarenzi, Zevio (VR): A. Testa, L. Montagna; Università degli Studi dell’Insubria, Divisione di Medicina Interna I, Ospedale di Circolo e Fondazione Macchi, Varese: A. Venco, A. Bertolini, M. Gianni, F. Solbiati.


   Notes
Top
 Notes
Abstract
 1. Introduction
 2. Methods
 3. Results
 4. Discussion
 References
 
1 See Appendix for complete list of Investigators. Back


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

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