Symptoms, functional status and quality of life in patients with controlled and uncontrolled atrial fibrillation: data from the RealiseAF cross-sectional international registry
- P Gabriel Steg1,2,
- Samir Alam3,
- Chern-En Chiang4,
- Habib Gamra5,
- Marnix Goethals6,
- Hiroshi Inoue7,
- Laura Krapf1,2,
- Thorsten Lewalter8,
- Ihsen Merioua9,
- Jan Murin10,
- Lisa Naditch-Brûlé9,
- Piotr Ponikowski11,
- Mårten Rosenqvist12,
- José Silva-Cardoso13,
- Oleg Zharinov14,
- Sandrine Brette15,
- James O Neill16 on behalf of the RealiseAF investigators*
- 1INSERM U-698, Paris, France, Université Paris-Diderot, Paris, France
- 2Assistance Publique - Hôpitaux de Paris, Centre Hospitalier Bichat-Claude Bernard, Paris, France
- 3Division of Cardiology, American University of Beirut Medical Centre, Beirut, Lebanon
- 4General Clinical Research Center, Taipei Veterans General Hospital and National Yang-Ming University, Taipei, Taiwan
- 5Cardiology A Department, Cardiothrombosis Research Unit, Fattouma Bourguiba University Hospital, Monastir, Tunisia
- 6Department of Cardiology-Electrophysiology, H.-Hartziekenhuis Roeselare-Menen, Roeselare, Belgium
- 7Second Department of Internal Medicine, University of Toyama, Toyama, Japan
- 8St Marienhospital, Academic Hospital, University of Bonn, Bonn, Germany
- 9Global Anti-arrhythmics, Sanofi, Paris, France
- 10Department of Internal Medicine and Cardiology, Comenius University, Bratislava, Slovakia
- 11Department of Heart Disease, Medical University, Wroclaw, Poland
- 12Karolinska Institutet, Södersjukhuset, Stockholm, Sweden
- 13Department of Cardiology, Porto Medical School, Hospital São João, Porto, Portugal
- 14National Medical Academy of Postgraduate Education, Kiev, Ukraine
- 15Statistician, Lincoln, Boulogne-Billancourt, France
- 16Connolly/Mater Hospitals/RCSI, Dublin, Ireland
- Correspondence to Professeur Ph. Gabriel Steg, INSERM U-698 “Recherche Clinique en Athérothrombose” Université Paris VII - Denis Diderot, Assistance Publique - Hôpitaux de Paris, Centre Hospitalier Bichat-Claude Bernard, 46 rue Henri Huchard, 75877 PARIS Cedex 18, FRANCE;
Contributors The study was designed, conducted and the manuscript written by an academic international steering committee. All authors were active participants in the production of this article and have provided final approval to submit the article.
- Accepted 4 August 2011
- Published Online First 22 September 2011
Background Rate control and rhythm control are accepted management strategies for atrial fibrillation (AF).
Objective RealiseAF aimed to describe the success of either strategy and the impact of control on symptomatic status of patients with AF.
Methods This international, observational, cross-sectional survey of patients with any history of AF in the previous year, recorded AF characteristics, management and frequency of control (defined as sinus rhythm or AF with resting heart rate ≤80 bpm).
Results Overall, 9665 patients were evaluable for AF control, with 59.0% controlled (sinus rhythm 26.5%, AF ≤80 bpm 32.5%) and 41.0% uncontrolled. Symptom prevalence in the previous week was lower in controlled than uncontrolled AF (55.7% vs 68.4%; p<0.001) and similar for patients in sinus rhythm versus AF ≤80 bpm (54.8% vs 56.4%; p=0.23). At the visit, AF-related functional impairment (EHRA class >I) was seen in 67.4% of patients with controlled AF and 82.1% of patients with uncontrolled AF (p<0.001). Quality-of-life (QoL, measured using EQ-5D) was better for patients with controlled versus uncontrolled AF using the Visual Analogue Scale (mean (SD) score 67.1 (18.4) vs 63.2 (18.9); p<0.001), single index utility score (median 0.78 vs 0.73; p<0.001), or five dimensions of well-being (all p<0.001). Irrespective of AF control, cardiovascular events had led to hospitalisation in the past year in 28.1%.
Conclusion AF control is not optimal. Control appears to be associated with fewer symptoms and better QoL, but even patients with controlled AF have frequent symptoms, functional impairment, altered QoL and cardiovascular events. New treatments are needed to improve control and minimise the functional and QoL burden of AF.
- Acute coronary syndrome
- atrial fibrillation
- atrial flutter
- cardiac function
- interventional cardiology
- coronary stenting
- percutaneous valve therapy
- cardiac function
- artificial heart
- heart transplant
- heart failure
- cardiogenic shock
- sinus node function
- heart failure
- systolic heart failure
- heart failure treatment
- atrial fibrillation
Presented in part at the European Society of Cardiology Congress, Stockholm, Sweden, September 2010.
Funding RealiseAF was sponsored by Sanofi, who provided assistance with data collection. The study was designed, conducted and the manuscript written by an academic international steering committee, with non-voting participation of the sponsor representatives. The statistical analysis was performed by a contract organisation (Registrat-MAPI), funded by the sponsor, under the supervision of a statistician from Lincoln, mandated by Sanofi. The sponsor had no role in submitting the paper for publication.
Competing interests All authors have completed the unified competing interest form and make the following declarations: PGS has received research grants from Servier; consultancy fees/honoraria from Astellas, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo/Eli Lilly alliance, GlaxoSmithKline, Medtronic, Merck Sharpe and Dohme, Roche, Sanofi, Servier and The Medicines Company; and has equity ownership in Aterovax. C-EC has received honoraria from AstraZeneca, Boehringer Ingelheim, Daiichi-Sankyo, MSD, Novartis, Pfizer and Sanofi. HG has received honoraria from Sanofi and Novartis; and acts as a non-paid advisor to Sanofi and AstraZeneca. MG has received consultancy fees/honoraria from Boehringer-Ingelheim and Sanofi. HI has received consultancy fees/honoraria from Bayer, Boehringer-Ingelheim, Bristol-Myers Squibb, Daiichi-Sankyo and Sanofi. TL has received research grants and consultancy fees/honoraria from Boehringer Ingelheim, Biotronik, Medtronic, Novartis and Sanofi. IM and LN-B are employees of Sanofi. JM has received consultancy fees from Sanofi. PP has received consultancy fees/honoraria from Merck and Sanofi. MR has received research grants from Boehringer Ingelheim, Bristol-Myers Squibb, Medtronic and Sanofi and consultancy fees/honoraria from Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Medtronic, Nycomed and Sanofi. JSC reports board membership for Abbott, AstraZeneca, Pfizer and Sanofi; has received grants from Abbott; consultancy fees/honoraria from Abbott, AstraZeneca, Menarini, Merck, Merck Sharpe and Dohme, Novartis, Pfizer and Sanofi. OZ has received consultancy fees/honoraria from Sanofi. SB is an employee of Lincoln, mandated by Sanofi to oversee and review statistical analyses performed by Registrat-MAPI. JO'N has received consultancy fees/honoraria from Sanofi. SA and LK declare no competing interests.
Ethics approval This study was conducted with the approval of the appropriate boards in each country.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement As the corresponding author, I, Gabriel Steg, have the right to grant on behalf of all authors and do grant on behalf of all authors, an exclusive licence (or non-exclusive for UK Crown Employees) on a worldwide basis to the BMJ Publishing Group Ltd and its Licensees to permit this article (if accepted) to be published in Heart and any other BMJPGL products and to exploit all subsidiary rights, as set out in our licence.