RHYTHM-AF: design of an international registry on cardioversion of atrial fibrillation and characteristics of participating centers

Harry J G M Crijns, Lori D Bash, François Chazelle, Jean-Yves Le Heuzey, Thorsten Lewalter, Gregory Y H Lip, Aldo P Maggioni, Alfonso Martín, Piotr Ponikowski, Mårten Rosenqvist, Prashanthan Sanders, Mauricio Scanavacca, Alexandra A Bernhardt, Sreevalsa Unniachan, Hemant M Phatak, Anselm K Gitt, Harry J G M Crijns, Lori D Bash, François Chazelle, Jean-Yves Le Heuzey, Thorsten Lewalter, Gregory Y H Lip, Aldo P Maggioni, Alfonso Martín, Piotr Ponikowski, Mårten Rosenqvist, Prashanthan Sanders, Mauricio Scanavacca, Alexandra A Bernhardt, Sreevalsa Unniachan, Hemant M Phatak, Anselm K Gitt

Abstract

Background: Atrial fibrillation is a serious public health problem posing a considerable burden to not only patients, but the healthcare environment due to high rates of morbidity, mortality, and medical resource utilization. There are limited data on the variation in treatment practice patterns across different countries, healthcare settings and the associated health outcomes.

Methods/design: RHYTHM-AF was a prospective observational multinational study of management of recent onset atrial fibrillation patients considered for cardioversion designed to collect data on international treatment patterns and short term outcomes related to cardioversion. We present data collected in 10 countries between May 2010 and June 2011. Enrollment was ongoing in Italy and Brazil at the time of data analysis. Data were collected at the time of atrial fibrillation episode in all countries (Australia, Brazil, France, Germany, Italy, Netherlands, Poland, Spain, Sweden, United Kingdom), and cumulative follow-up data were collected at day 60 (±10) in all but Spain. Information on center characteristics, enrollment data, patient demographics, detail of atrial fibrillation episode, medical history, diagnostic procedures, acute treatment of atrial fibrillation, discharge information and the follow-up data on major events and rehospitalizations up to day 60 were collected.

Discussion: A total of 3940 patients were enrolled from 175 acute care centers. 70.5% of the centers were either academic (44%) or teaching (26%) hospitals with an overall median capacity of 510 beds. The sites were mostly specialized with anticoagulation clinics (65.9%), heart failure (75.1%) and hypertension clinics (60.1%) available. The RHYTHM-AF registry will provide insight into regional variability of antiarrhythmic and antithrombotic treatment of atrial fibrillation, the appropriateness of such treatments with respect to outcomes, and their cost-efficacy. Observations will help inform strategies to improve cardiovascular outcomes in patients with atrial fibrillation.

Trial registration: Clinical trials NCT01119716.

Figures

Figure 1
Figure 1
Distribution of patients per country.
Figure 2
Figure 2
Patient enrollment over time in participating countries. Figure 2- the curves are normalized for time of start of recruitment.
Figure 3
Figure 3
Participating hospital characteristics.
Figure 4
Figure 4
Distribution of the percentages of centers per country reporting to use PCV or ECVnever,” “sometimes,” orfrequentlyas reported in site questionnaires.

References

    1. Heeringa J, van der Kuip DA, Hofman A, Kors JA, van Herpen G, Stricker BH, Stijnen T, Lip GY, Witteman JC. Prevalence, incidence and lifetime risk of atrial fibrillation: the Rotterdam study. Eur Heart J. 2006;27:949–953.
    1. Go AS, Hylek EM, Phillips KA, Chang Y, Henault LE, Selby JV, Singer DE. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the ATRIA study. JAMA. 2001;285:2370–2375. doi: 10.1001/jama.285.18.2370.
    1. DeWilde S, Carey IM, Emmas C, Richards N, Cook DG. Trends in the prevalence of diagnosed atrial fibrillation, its treatment with anticoagulation and predictors of such treatment in UK primary care. Heart. 2006;92(8):1064–1070. doi: 10.1136/hrt.2005.069492.
    1. Stefansdottir H, Aspelund T, Gudnason V, Arnar DO. Trends in the incidence and prevalence of atrial fibrillation in Iceland and future projections. Europace. 2011;13:1110–1117. doi: 10.1093/europace/eur132.
    1. Naccarelli GV, Varker H, Lin J, Schulman KL. Increasing prevalence of atrial fibrillation and flutter in the United States. Am J Cardiol. 2009;104:1534–1539. doi: 10.1016/j.amjcard.2009.07.022.
    1. Wachtell K, Hornestam B, Lehto M, Slotwiner DJ, Gerdts E, Olsen MH, Aurup P, Dahlöf B, Ibsen H, Julius S, Kjeldsen SE, Lindholm LH, Nieminen MS, Rokkedal J, Devereux RB. Cardiovascular morbidity and mortality in hypertensive patients with a history of atrial fibrillation: The Losartan Intervention For End Point Reduction in Hypertension (LIFE) study. J Am Coll Cardiol. 2005;45:705–711. doi: 10.1016/j.jacc.2004.06.080.
    1. Miyasaka Y, Barnes ME, Gersh BJ, Cha SS, Bailey KR, Seward JB, Iwasaka T, Tsang TS. Coronary ischemic events after first atrial fibrillation: risk and survival. Am J Med. 2007;120:357–363. doi: 10.1016/j.amjmed.2006.06.042.
    1. Sanoski CA. Clinical, economic, and quality of life impact of atrial fibrillation. J Manag Care Pharm. 2009;15(6 Suppl B):S4–S9.
    1. Meinertz T, Kirch W, Rosin L, Pittrow D, Willich SN, Kirchhof P. ATRIUM investigators. Management of atrial fibrillation by primary care physicians in Germany: baseline results of the ATRIUM registry. Clin Res Cardiol. 2011;100(10):897–905. doi: 10.1007/s00392-011-0320-5.
    1. Wong CX, Brooks AG, Leong DP, Roberts-Thomson KC, Sanders P. The increasing burden of atrial fibrillation compared to heart failure and myocardial infarction: a 15-year study of all hospitalizations in Australia. Arch Intern Med. 2012;172(9):739–741. doi: 10.1001/archinternmed.2012.878.
    1. Hagens VE, Ranchor AV, Van Sonderen E, Bosker HA, Kamp O, Tijssen JG, Kingma JH, Crijns HJ, Van Gelder IC. RACE Study Group. Effect of rate or rhythm control on quality of life in persistent atrial fibrillation. Results from the Rate Control versus Electrical Cardioversion (RACE) Study. J Am Coll Cardiol. 2004;43(2):241–247. doi: 10.1016/j.jacc.2003.08.037.
    1. Lown B, Amarasingham R, Neuman J. New method for terminating cardiac arrhythmias. Use of synchronized capacitor discharge. JAMA. 1962;182:548–555.
    1. Van Gelder IC, Tuinenburg AE, Schoonderwoerd BS, Tieleman RG, Crijns HJ. Pharmacologic versus direct-current electrical cardioversion of atrial flutter and fibrillation. Am J Cardiol. 1999;84(9A):147R–151R.
    1. Gallagher MM, Yap YG, Padula M, Ward DE, Rowland E, Camm AJ. Arrhythmic complications of electrical cardioversion: relationship to shock energy. Int J Cardiol. 2008;123(3):307–312. doi: 10.1016/j.ijcard.2006.12.014.
    1. Alboni P, Botto GL, Baldi N, Luzi M, Russo V, Gianfranchi L, Marchi P, Calzolari M, Solano A, Baroffio R, Gaggioli G. Outpatient treatment of recent-onset atrial fibrillation with the “pill-in-the-pocket” approach. N Engl J Med. 2004;351(23):2384–2391. doi: 10.1056/NEJMoa041233.
    1. Camm AJ, Kirchhof P, Lip GY, Schotten U, Savelieva I, Ernst S, Van Gelder IC, Al-Attar N, Hindricks G, Prendergast B, Heidbuchel H, Alfieri O, Angelini A, Atar D, Colonna P, De Caterina R, De Sutter J, Goette A, Gorenek B, Heldal M, Hohloser SH, Kolh P, Le Heuzey JY, Ponikowski P, Rutten FH. Association European Heart Rhythm European Association for Cardio-Thoracic Surgery. Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC) Eur Heart J. 2010;31(19):2369–2429.
    1. Pisters R, Nieuwlaat R, Prins MH, Le Heuzey JY, Maggioni AP, Camm AJ, Crijns HJ. Clinical correlates of immediate success and outcome at 1-year follow-up of real-world cardioversion of atrial fibrillation: the Euro Heart Survey. Europace. 2012;14:666–674. doi: 10.1093/europace/eur406. Epub ahead of print.
    1. Tieleman RG, Gosselink AT, Crijns HJ, van Gelder IC, van den Berg MP, de Kam PJ, van Gilst WH, Lie KI. Efficacy, safety, and determinants of conversion of atrial fibrillation and flutter with oral amiodarone. Am J Cardiol. 1997;79:53–57. doi: 10.1016/S0002-9149(96)00675-3.
    1. Singh BN, Singh SN, Reda DJ, Tang XC, Lopez B, Harris CL, Fletcher RD, Sharma SC, Atwood JE, Jacobson AK, Lewis HD Jr, Raisch DW, Ezekowitz MD. Sotalol Amiodarone Atrial Fibrillation Efficacy Trial (SAFE-T) Investigators. Amiodarone versus sotalol for atrial fibrillation. N Engl J Med. 2005;352:1861–1872. doi: 10.1056/NEJMoa041705.
    1. Van Gelder IC, Groenveld HF, Crijns HJ, Tuininga YS, Tijssen JG, Alings AM, Hillege HL, Bergsma-Kadijk JA, Cornel JH, Kamp O, Tukkie R, Bosker HA, Van Veldhuisen DJ, Van den Berg MP. RACE II Investigators. Lenient versus strict rate control in patients with atrial fibrillation. N Engl J Med. 2010;362(15):1363–1373. doi: 10.1056/NEJMoa1001337.
    1. Hendriks JML, De Wit R, Crijns HJGM, Vrijhoef HJM, Prins MH, Pisters R, Pison LAFG, Blaauw Y, Tieleman RG. Nurse-Led care versus usual care for patients with atrial fibrillation. Results of a randomized trial of integrated chronic care versus routine clinical care in ambulatory patients with atrial fibrillation. Eur Heart J. 2012. in press.

Source: PubMed

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