Europace Advance Access published online on April 10, 2008
Europace, doi:10.1093/europace/eun086
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Atrial fibrillation management by practice cardiologists: a prospective survey on the adherence to guidelines in the real world
Cardiovascular Department, Hôpital de La Tour, Meyrin 1217, Geneva, Switzerland
Manuscript submitted 23 January 2008. Accepted after revision 18 March 2008.
* Corresponding author. Tel: +41 22 782 97 78; fax: +41 22 785 18 63. E-mail address: zimmermann.family{at}bluewin.ch
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Abstract |
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Aims: The purpose of this prospective study was to characterize the clinical profile of patients with atrial fibrillation (AF) in cardiology practice and to assess how successfully guidelines have been implemented in real-world practice.
Methods and results: This prospective study involved 23 cardiologists established in office practice in Geneva. Enrolment started on 1 January 2005 and ended on 31 December 2005. Consecutive patients were included if they were >18 years and had AF documented on an ECG during the index office visit or during the preceding month. In this survey, 622 ambulatory patients were enrolled (390 males and 232 females; mean age 69.8 ± 11.8 years). The prevalence of paroxysmal, persistent, and permanent AF was 35, 18, and 47%, respectively. Underlying cardiac disorders present in 513 patients (82%) included hypertensive heart disease (30%), valvular heart disease (27%), coronary artery disease (18%), and myocardial disease (11%). A rate-control strategy was chosen in 53% of the patients (331/622). The mean CHADS2 score was 1.43 ± 1.24, and 458/622 patients (73.6%) had a CHADS2 score 
1. Among patients with an indication to oral anticoagulant therapy (OAT), 88% (403/458) effectively received it. The rate of OAT was closely correlated with an increasing CHADS2 score, particularly with patients age (72, 81, and 87% for patients <65, 65–75, and >75 years of age, respectively). True contraindication for OAT was present in 4% (18/458). In the low-risk group (CHADS2 score = 0), 58% were prescribed OAT, but in 37% of them only for a short period of time (cardioversion/ablation). After a follow-up of 396 ± 109 days, 72% of the study group (410/570) was still treated by OAT. During follow-up, 23/570 patients died (4%), essentially from a cardiovascular cause (15/23), 15 had a non-lethal embolic stroke (2.7%), and 8 had significant bleeding complications (1.5%).
Conclusion: This study shows one of the highest OAT prescription rates for AF reported until now and demonstrates how successfully guidelines can be applied in the real world. A definite overinterpretation of current guidelines is observed in low-risk patients with AF. True contraindication for OAT (4%) and significant bleeding during OAT (1.5%) were rare.
Key Words: Atrial fibrillation, Anticoagulants, Stroke, Guidelines
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Introduction |
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Atrial fibrillation (AF) is the most commonly sustained cardiac arrhythmia, strongly associated with an increased morbidity and mortality. Atrial fibrillation causes a five-fold rise in the risk of stroke, and one of every six strokes occurs in a patient with AF. Despite evidence of benefit for cardio-embolic complications with oral anticoagulation,1
this therapy is often underused in this setting.2–7 Atrial fibrillation is also associated with heart failure, resulting in frequent visits to physicians and departments as well as increased hospitalizations, and this is reflected in an increasing economic burden. In the last decade, important acquisitions in the management of AF have emerged, particularly concerning treatment strategies (rate vs. rhythm control),8 stroke prevention scales (validation of a new stroke risk index—the CHADS2 score), and publication of ‘unified’ guidelines (ACC/AHA/ESC) for AF management.9 Several community-based studies have provided important data on these topics, but most of these reports are older than 10 years, which have focused on hospitalized patients or were performed by highly specialized centres.10–13 Only a few studies have targeted the out-of-hospital population,14 and most of them were performed before the release of ACC/AHA/ESC guidelines. Moreover, stroke risk stratification in most of these studies was not perfectly defined. The purposes of this prospective study were: (i) to characterize the clinical profile of patients with AF in cardiology practice with special attention paid to anti-thrombotic treatment and to the proposed treatment strategy and (ii) to assess how successfully guidelines have been implemented in real-world practice. |
Methods |
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This prospective survey, entitled AF in Geneva (AFIB Geneva), involved 23 cardiologists established in office practice representing 62% of the cardiologists in the canton of Geneva, Switzerland.
Patients
Patients were prospectively included if they were 18 years or older and had documented AF on an ECG during the index office visit or in the preceding month. Patients with atrial flutter were excluded. Enrolment started on 1 January 2005 and ended on 31 December 2005, and by definition, only outpatients were enrolled. The specifically designed report form included patient’s characteristics, presence and type of underlying heart disease, thyroid status, excessive alcohol intake, high level of sporting activities, anti-arrhythmic treatment, and anticoagulation status. Diagnosis of hypertensive heart disease required a history of hypertension and an echocardiographic evidence of left ventricular hypertrophy and/or systolic or diastolic dysfunction. Coronary artery disease was diagnosed on the basis of a documented history of angina/myocardial infarction or on the presence of significant coronary obstructive lesions on an angiogram. Patients symptoms directly related to AF were also recorded.
Atrial fibrillation classification
Atrial fibrillation was subdivided into three clinical patterns at presentation: paroxysmal non-sustained (<1 min) or sustained (>1 min but <7 days), persistent (>7 days but <3 months), and permanent (>3 months). The term ‘new onset AF’ was applied when AF was recorded for the first time, and the estimated duration of the AF episode was reported. The term ‘lone AF’ was defined as an episode of AF in a patient younger than 65 years with exclusion of clinical, biochemical, and echocardiographic evidence of cardiovascular disease. The choice of management strategy was indicated as well as prior or intended direct current cardioversion. Specific therapy proposed at the end of office visit was included in the report.
Stroke risk stratification
We used the recently validated CHADS2 score to stratify the patients for stroke risk.15 Briefly, this index measures stroke risk by assigning one point each for congestive heart failure, hypertension, age 75 years or older, and diabetes mellitus, with two points added for a history of stroke or transient ischaemic attack (TIA).
Diagnostic evaluation
Two-dimensional and Doppler transthoracic echocardiography was performed with special attention paid to the left atrial size, left ventricular systolic and diastolic function, presence of valvular heart disease, and pulmonary arterial hypertension. Coronary angiography was only performed if clinically indicated.
Follow-up
Follow-up information was required 12 months after inclusion in all patients. A specifically designed follow-up form was prepared to evaluate the effect of anti-arrhythmic treatment, the rate of sinus rhythm maintenance, the rate and timing of AF recurrences, and complications. Deaths were classified as cardiovascular, non-cardiovascular, or unknown.
Statistical analysis
Continuous variables are expressed as mean ± standard deviation and categorical variables as percentages. Differences in continuous variables between the two groups were evaluated using unpaired t-test when comparing two groups and with ANOVA when comparing three groups, and differences in categorical variables were evaluated using Fisher’s exact test. A P-value of less than 0.05 was considered as statistically significant.
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Results |
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Patients characteristics
In this survey, 622 patients were enrolled by 23 cardiologists. The contribution of each cardiologist was variable and enrolment ranged from 1 to 144 patients per cardiologist (mean 27 ± 33 and median 14). Baseline clinical characteristics of the patients are summarized in Table 1. The male/female ratio was 0.63 (390 males and 232 females). The age ranged from 31 to 97 years with a mean age of 69.8 ± 11.8 years. Underlying cardiac diseases were present in 513 patients (82%), the remaining patients belonging to the ‘lone AF’ group (n = 109). Hypertension was the most prevalent associated medical condition, diagnosed in 56% of the patients, with hypertensive heart disease in only 53% of them. A history of previous cerebrovascular accident was present in 12%, and 25% of the study group had a history of hospitalization directly related to AF.
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Atrial fibrillation was paroxysmal in 220 patients (35.4%), persistent in 113 patients (18.1%), and permanent in 289 patients (46.5%). The heart rate was significantly higher in the paroxysmal form when compared with the persistent or with the permanent form (115 ± 26 vs. 101 ± 26 and 84 ± 19 bpm, respectively, P < 0.0001). For 30.4% of the patients (189/622), AF at inclusion could be classified as ‘new onset’. Seventy-four per cent of patients reported AF-related symptoms, which were essentially dyspnoea (49%), palpitations (45%), malaise (14%), or congestive heart failure (11%). Syncope was rarely reported (2%). Extracardiac factors which could have precipitated AF were thyroid disease (5%), excessive alcohol intake (9%), and regular heavy sporting activities (6%).
Diagnostic evaluation
An echocardiographic examination was made in 607 patients (98%). The main findings were slight enlargement of the left atrium in 72% (mean 45 ± 8 mm), a preserved left ventricular function in 74%, the presence of diastolic dysfunction in 24%, and signs of pulmonary hypertension in 8% (Table 1). Coronary angiography was performed in 26% (161/622) of the study group, and significant coronary artery disease was diagnosed in 15% (96/622).
Rhythm management
Rate control was the predominant strategy chosen in 53.2% of the patients (331/622), whereas the remaining 291 patients (46.8%) were treated using a rhythm-control approach. Patients treated according to the rate-control strategy had a higher CHADS2 index (1.80 vs. 1.02, P < 0.0001) and a higher anticoagulation rate compared with the patients assigned to the rhythm-control strategy (89 vs. 71%, P < 0.0001). Anti-arrhythmic drug therapy for the three forms of AF is summarized in Table 2. Direct-current cardioversion was performed electively in 17.4% of the patients with persistent or permanent AF (64/368), and radiofrequency catheter ablation (pulmonary vein isolation) was proposed in 4.8% of the study group (30/622).
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Stroke risk stratification and anticoagulation therapy
Oral anticoagulant therapy (OAT) was prescribed in 498/622 patients (80%) in this study with a mean CHADS2 score of 1.45 ± 1.24. For the vast majority of the patients (458/622, 73.6%), the main indication was a CHADS2 score of
1, i.e. the presence of at least one stroke risk factor. Anticoagulation was prescribed in 151/185 patients with a CHADS2 score of 1 (81.6%) and in 252/273 patients with a CHADS2 score of 2 (92.3%). Therefore, 88% (403/458) of the patients who should be prescribed anticoagulant prophylaxis had received this therapy. Conversely, in the group of patients with a CHADS2 score of 0, 57.9% of these low-risk patients (95/164) were prescribed anticoagulant prophylaxis. In 35/95 of these patients (36.8%), OAT was prescribed for a short period of time (mean 2.1 ± 1.8 month) in order to perform electrical cardioversion or ablation. Anti-thrombotic prophylaxis according to each CHADS2 score is summarized in Table 3 and graphically represented in Figure 1. In assessing the impact of age on anti-thrombotic therapy, we analysed three different age groups: <65, 65–75, and >75 years. The anticoagulation rates were 72.4, 80.5, and 86.6% for the three subgroups, respectively. Mean CHADS2 score values were 0.96, 1.05, and 1.78 in the paroxysmal, persistent, and permanent forms, respectively. Patients with the persistent and permanent forms of AF were more often anticoagulated than those with the paroxysmal form of AF (92 and 91 vs. 59%, P < 0.0001).
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Follow-up
Follow-up data were obtained in 570/622 patients (91.6%) and the mean follow-up was 396 ± 109 days. At the time of the last follow-up, rate control was applied in 319/570 (56.0%) and rhythm control in 251/570 (44.0%). Twenty-seven patients (8.2%) crossed-over from the rate to rhythm control and 45/291 (15.5%) switched from a rhythm-control to a rate-control strategy. At the end of the follow-up period, 242/570 patients (42.5%) were in sinus rhythm, 227/251 (90.4%) in the rhythm-control group, and 15/319 (4.7%) in the rate-control group. Class I anti-arrhythmic drug therapy was still used by 60/570 patients (10.5%), β-blockers by 295/570 (51.8%), amiodarone by 98/570 (17.2%), calcium channel antagonists by 106/570 (18.6%), and digitalis by 152/570 (26.7%). During the follow-up period, atrioventricular node ablation was performed in 14/570 patients (2.5%) and pulmonary vein isolation in 33/570 patients (5.8%). In the rhythm-control group, only 39/319 patients (9.4%) had no anti-arrhythmic drug therapy at last follow-up, and in 18/39 (46.2%), the absence of drug therapy was related to successful pulmonary vein isolation. At the follow-up visit, 410/570 patients (71.9%) were still treated by OAT and 196/570 (34.4%) were on aspirin. Oral anticoagulant therapy was stopped during the follow-up period in 74/498 (14.9%) (60 in the rhythm-control group and 14 in the rate-control group). Oral anticoagulant therapy was instituted during follow-up in 23/124 (18.5%).
During follow-up, 23/570 patients were died (4.0%). The mean age of the patients who died was 78.7 ± 10.9 years. Death was cardiovascular in origin in 15/23 patients (65%) (2/15 in the rhythm-control group and 13/15 in the rate-control group; 14/15 treated by OAT; 12/15 sudden death; 2 non-sudden cardiac death; and 1 cerebral haemorrhage). The remaining deaths were related to cancer in three (13%) and of unknown origin in five (22%). Among the 547 survivors, there were 15 non-lethal embolic stroke or TIA (2.7%) (12/15 in the rate-control group and 4/15 without OAT). Eight significant bleeding complications (1.5%) were reported (one intracranial, one epidural, one gastrointestinal, one tamponade, one haemoptysis, two epistaxis, and one dental): 6/8 bleeding complications occurred in the rate-control group; 8/8 of these patients were treated by oral anticoagulation; and 6/8 complications occurred in patients older than 80 years of age. Forty episodes of congestive heart failure (16.2%) and 20 hospitalizations for uncontrolled AF (8.1%) were observed during follow-up.
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Discussion |
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Main findings
The main results of this prospective study performed in an out-of-hospital patient population followed by cardiologists can be summarized as follows:
- A rate-control strategy was the preferred option by cardiologists in 53% of the patients presenting with AF during the office visit and this percentage increased to 56% after 1 year of follow-up.
- To the best of our knowledge, this study shows the highest oral anticoagulation prescription rate for AF reported until now and demonstrates how successfully ACC/AHA/ESC guidelines can be applied in the real world. Eighty-eight per cent of the patients with a moderate or high stroke risk effectively received OAT and true contraindications for OAT were encountered in only 4% of the study group.
- In low-risk patients, OAT prescription rate was 58%, which denotes a definite overinterpretation of current guidelines.
- The rate of significant bleeding during the first year of OAT treatment is low (2.2%) even in patients >80 years of age (4.2%).
Treatment strategy
Rate-control was adopted in 53% of the patients mainly because of lack of symptoms or because of long-lasting AF. Pharmacological approach was comparable with what was observed in the Euro Heart Survey except that β-blockers were more often used for rate control and amiodarone was less often prescribed for rhythm control. Electrical cardioversion was planned in 17% of the study group and radiofrequency catheter ablation was proposed in 4.5% of cases, a figure which is concordant with results from the Euro Heart Survey.13
Anti-thrombotic prophylaxis
To define the stroke risk categories, we used the CHADS2 score validated by Gage et al.15 in 2001 because essentially this scoring system is simple, easy to use, and efficient. According to the CHADS2 score, patients with at least one stroke risk factor have an annual stroke risk of 2.8 and should be prescribed OAT. Such a condition was observed in 458/622 patients (73.6%) in our study group. The main finding is that 88% of the patients who should be prescribed OAT had received this therapy. This prescription rate appears to be the highest ever reported and represents the best adherence level between the guidelines and ‘real-world’ clinical practice. This high OAT prescription rate may be related to the fact that this study was performed by cardiologists who have a good knowledge of the guidelines5 and to a good control of the anticoagulation level in our environment (widespread availability of facilities for INR checks and excellent cooperation with general practitioners and visiting nurses) making physicians perceive bleeding as an unlikely event.
Prior studies performed with a similar out-of-hospital population and a comparable stroke risk reported much lower anticoagulation rates but most of these studies were published before ACC/AHA/ESC guidelines release.2,14,16 Only 37% of the patients received an anticoagulation therapy in a community-based study representative of the elderly population of the USA in 199917, for example. In the French ALFA study,14 a similar ambulatory cohort also followed exclusively by cardiologists, only 40% of the patients received OAT. In the recent Euro Heart Survey,7,13 published after the release of the ACC/AHA/ESC guidelines, OAT was prescribed in 67% of the eligible patients. These results were encouraging and could partially be attributed to the impact of the guidelines on the management of AF. However, anticoagulation rate could have been even higher considering the studied population: half of the patients were included by university reference centres, mainly by cardiology units with electrophysiological facilities or specialized in AF management. With regard to the broad sample of participating countries, results of the Euro Heart Survey represented only an average of the different clinical approaches among European countries. In another recent out-of-hospital study performed in the Canton of Zurich (Switzerland), Marty et al.18 reported a high level of guidelines adherence by general practitioners as 74% of patients with an indication for OAT actually received it. A relatively high percentage of patients (15.9%) received both OAC and aspirin, essentially because of associated vascular or coronary artery disease; this observation underlines the fact that physicians in the present study believe that both drugs offer different mechanisms of protection and perceive bleeding as an unlikely event.
Anti-thrombotic prophylaxis and type of atrial fibrillation
Patients with paroxysmal AF were less often prescribed OAT (59%) than those with persistent (92%) or permanent AF (91%) (P < 0.0001), and such an observation has already been made by others.7,12 Although epidemiological studies showed no real difference in the risk of stroke between paroxysmal AF and chronic AF, 19,20 the difference in OAT prescription in this study and in others appears to be due to physician’s and patient’s perception that paroxysmal forms of AF carry a lower risk13 as well as to a lower patients mean age and lower CHADS2 score in paroxysmal AF.
Anti-thrombotic prophylaxis and age
By opposition to several other studies, we did not observe a negative effect of age on the rate of OAT prescription.5,12,16,17,21,22 Elderly patients have the maximal benefit of OAT as they usually have many comorbidities and the highest CHADS2 score. In our study, the rate of OAT prescription increased with advancing age: 72% in the <65 years group, 81% in the 66–75 years group, and 87% in the >75 years group. In fact, only 7/458 eligible patients (1.5%) were denied OAT only on the basis of age (>85 years in 7/7) and only 1/458 patient refused OAT (0.2%).
Anti-thrombotic prophylaxis and gender
In the present study, there was no difference in OAT between men and women (315/390, 80.8% vs. 183/232, 78.9%, P = 0.6), and this result differs from what was observed by DeWilde et al.16 in the UK. In our study group, there was no statistical difference in none of the parameters between men and women except for age at presentation (68 ± 11 vs. 73 ± 11, P = 0.002).
Overtreatment in low-risk atrial fibrillation patients
In this study, 58% of the AF patients with a low-risk profile received OAT despite ineligibility according to current guidelines, a rate similar to the one observed in the Euro Heart Survey.13 Overtreatment was related partly to a periprocedural period (cardioversion or ablation in 36.8% in the present study),23,24 but was also probably related to physician’s and patient’s fear of a disabling stroke in young patients.
Follow-up
In the present study, overall mortality at 1 year was 4%, which is in accordance with data from the ALFA14 or the AFFIRM study25 with two-thirds of deaths being related to cardiovascular causes. Stroke rate was relatively low (2.7%) in accordance with previous studies,14 but lower than what was observed for the entire population in the AFFIRM study25 and much lower than untreated groups in randomized trials of anti-thrombotic therapy (4.9–8.0% according to age).26 Possible explanations are the high rate of OAT in high-risk patients in our study and facilities related to INR control in our environment. Major haemorrhage during OAT was low (1.5%) even in patients >80 years of age (4.2%), a result which is in accordance with previous observations from Copeland et al.27 but in opposition with the recent study of Hylek et al.28 which showed a very high rate of bleeding in patients >80 years of age (13.1%) and a high rate of OAT discontinuation in this group of patients despite CHADS2 scores 3. Differences between our study and the one of Hylek et al. may be due to the mean age of the study population (69.8 vs. 77 years), OAT experience (many patients were already taking OAT when they were enrolled in our study), sex distribution (female in 37.3 vs. 47%), or concomitant use of antiplatelet agents (15.6 vs. 40%).
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Limitations |
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Results of the present study are only applicable to an out-of-hospital population of patients with AF and may not be applicable to the hospital-based population. Data were collected on a voluntary basis with its inherent limitations and enrolment was not uniform among participants. The way patients were managed may have been influenced by the study itself. The true burden of AF recurrence may have been underestimated as follow-up was a single visit at 12 months and some recurrences may have been completely asymptomatic. The value of the CHADS2 score used in this study may be subject to debate, especially in evaluating the risk associated with controlled hypertension and in defining the upper age limit (75 or 65 years?). The mean CHADS2 score in the present study was relatively low (1.43), possibly reflecting a lower stroke risk profile in this out-of-hospital cohort. In this study, we reported oral anticoagulation prescription rate but we could not ensure that this treatment was effective because it was not possible to have a complete overlook of the INR during the 1 year follow-up period. This limitation was particularly true for stroke or major bleedings as the INR was not available for most of the patients; therefore, no conclusion can be drawn concerning the exact cause of these events.
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Conclusion |
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This survey showed the highest OAT prescription rate for AF yet reported in the literature and demonstrated that ACC/AHA/ESC guidelines can be successfully applied in the ‘real-word’ clinical practice. In contrast to prior studies,6
we have not identified in this study any substantial underuse of anticoagulation therapy in different clinical settings, but only an excess of OAT prescription in lone AF. Moreover, the rate of major bleeding was low even in the elderly. Overutilization of OAT in low-risk patients is an another important issue. Such a result was obtained by cardiologists, but efforts should now be directed to improve education and diffusion of guidelines in other medical specialities to tailor optimally stroke prophylaxis to the patient’s risk profile. |
Participating investigators |
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C. Bacchiocchi-Suilen, M. Bettoni, A. Bloch, S. Burgan, P. Chatelain, Z. Chok, S. Ciaroni, E. De Benedetti, D. Fournet, J. Gabathuler, B. Haenni, Y. Hyman, J.L. Hoffmann, O. Jaques, J. Noble, F. Ricou, P. Schopfer, C. Selleger, J. Sztajzel, P. Urban, R. Vallet, B. Veragut-Davies, and M. Zimmermann.
Conflict of interest: none declared.
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Funding |
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A.M. was supported by a grant from the ‘Fondation de La Tour pour la Recherche Cardiovasculaire’.
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References |
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