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CLINICAL RESEARCH: CARDIAC RHYTHM DISORDER

Functional Status in Rate- Versus Rhythm-Control Strategies for Atrial Fibrillation

Results of the Atrial Fibrillation Follow-Up Investigation of Rhythm Management (AFFIRM) Functional Status Substudy

Mina K. Chung, MD, FACC^_*,_*, Lynn Shemanski, PhD, David G. Sherman, MD, H. Leon Greene, MD, FACC, David B. Hogan, MD, Joyce C. Kellen, RN, BN, MSc^||, Soo G. Kim, MD, FACC^¶, Lisa Warsinger Martin, MD^#, Yves Rosenberg, MD, MPH^_**, D. George Wyse, MD for the AFFIRM Investigators

^_* Department of Cardiovascular Medicine, The Cleveland Clinic Foundation, Cleveland, Ohio, USA
Axio Research Corporation, Seattle, Washington, USA
Department of Medicine, Division of Neurology, University of Texas, San Antonio, Texas, USA
Faculty of Medicine, University of Calgary, Calgary, Alberta, Canada
^|| Department of Medicine, University of Calgary, Calgary, Alberta, Canada
^¶ Montefiore Medical Center, Bronx, New York, USA
^# Kaiser Permanente Mid-Atlantic Region, Washington, DC, USA
^_** National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA.

Manuscript received April 25, 2005; revised manuscript received July 5, 2005, accepted July 11, 2005.

^_* Correspondence to: Dr. Mina K. Chung, Department of Cardiovascular Medicine, The Cleveland Clinic Foundation, 9500 Euclid Avenue, Desk F-15, Cleveland, Ohio 44195. Reprint requests to: Axio Research Corporation, 2601 4th Avenue, Suite 200, Seattle, Washington 98121. (Email: chungm{at}ccf.org).

OBJECTIVES: The Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) functional status substudy aimed to test the hypothesis that functional status is similar in rate-control and rhythm-control strategies.

BACKGROUND: Randomized studies, including the AFFIRM study, have failed to demonstrate survival benefits between rate-control and rhythm-control strategies for atrial fibrillation (AF). However, AF may cause functional capacity or cognitive impairment that might justify maintenance of sinus rhythm.

METHODS: Investigators of the AFFIRM study enrolled 4,060 patients with AF who required long-term therapy and who were 65 years of age or older or who had another risk factor for stroke or death. New York Heart Association functional class (NYHA-FC) and Canadian Cardiovascular Society Angina Classification were assessed at initial and each follow-up visit. From 22 randomly chosen functional status substudy sites, 245 participants underwent 6-min walk tests and Mini-Mental State Examination (MMSE) at initial, two-month, and yearly visits. Patients were assigned randomly to rate-controlling drugs, allowing AF to persist, or rhythm-controlling antiarrhythmic drugs, to maintain sinus rhythm.

RESULTS: The NYHA-FC worsened with time in both rate-control and rhythm-control groups, with no differences between groups. Presence of AF was associated with worse NYHA-FC (p < 0.0001). No differences were observed in Canadian Cardiovascular Society Angina Classification or MMSE scores. Six-minute walk distance improved over time in both study arms. On average, walk distance was 94 feet greater in the rhythm-control group (adjusted p = 0.049).

CONCLUSIONS: Modest improvement in 6-min walk distance was noted in the rhythm-control arm. Presence of AF was associated with worse NYHA-FC. No difference in cognitive function was detected.

Abbreviations and Acronyms   AF = atrial fibrillation   AFFIRM = Atrial Fibrillation Follow-up Investigation of Rhythm Management   CAD = coronary artery disease   CCS-AC = Canadian Cardiovascular Society angina classification   CHF = congestive heart failure   LVEF = left ventricular ejection fraction   MMSE = Mini-Mental State Examination   NYHA-FC = New York Heart Association functional class

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