Daniel P Fishbein1, Anne S Hellkamp2, Daniel B Mark3, Mary Norine Walsh4, Jeanne E Poole5, Jill Anderson6, George Johnson6, Kerry L Lee2, Gust H Bardy7. 1. Department of Medicine, Division of Cardiology, University of Washington, Seattle, Washington. Electronic address: dfish@u.washington.edu. 2. Department of Statistics, Duke Clinical Research Institute, Duke University, Durham, North Carolina. 3. Department of Medicine, Division of Cardiology, Duke University, Durham, North Carolina. 4. St Vincent Heart Center of Indiana, Indianapolis, Indiana. 5. Department of Medicine, Division of Cardiology, University of Washington, Seattle, Washington. 6. Seattle Institute for Cardiac Research, Seattle, Washington. 7. Department of Medicine, Division of Cardiology, University of Washington, Seattle, Washington; Seattle Institute for Cardiac Research, Seattle, Washington.
Abstract
OBJECTIVES: The purpose of this study was to determine if 6-min walk test data assists in treatment decisions for patients with heart failure. BACKGROUND: In the SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial), a pre-specified subgroup analysis showed that patients with New York Heart Association functional class III symptoms did not benefit from implantable cardioverter-defibrillator (ICD) therapy and appeared to be harmed by amiodarone, whereas New York Heart Association functional class II patients obtained significant survival benefit from ICD. We postulated that a more objective measure of functional capacity, such as 6-min walk (6MW) distance, might provide a better tool for selecting these preventive therapies. METHODS: A 6MW test was performed before randomization in 2,397 patients. Median follow-up was 45.5 months. All-cause mortality was the primary endpoint, with cause-specific mortality (heart failure, arrhythmic) examined in secondary analyses. RESULTS: The hazard ratios (HRs) for ICD therapy compared to placebo were estimated within tertiles of baseline 6MW distance: HR: 0.42 (95% confidence interval [CI]: 0.26 to 0.66) for 6MW distance >386 m (top tertile); HR: 0.57 (95% CI: 0.39 to 0.83) for 6MW distance 288 to 386 m (middle tertile); and HR: 1.02 (95% CI: 0.75 to 1.39) for 6MW distance <288 m (bottom tertile). The corresponding HRs for amiodarone compared to placebo were 0.68 (95% CI: 0.46 to 1.02) for the top, 0.86 (95% CI: 0.61 to 1.21) for the middle, and 1.56 (95% CI: 1.17 to 2.09) for the bottom tertile. The 6MW distance was inversely related to heart failure-related mortality but not to arrhythmic mortality. ICD therapy reduced arrhythmic mortality in the top 2 tertiles of 6MW, but had no effect on heart failure mortality. CONCLUSIONS: A baseline 6MW distance <288 m identified a subgroup of SCD-HeFT patients who were harmed by amiodarone therapy and did not benefit from ICD. (Sudden Cardiac Death in Heart Failure Trial [SCD-HeFT]; NCT00000609).
RCT Entities:
OBJECTIVES: The purpose of this study was to determine if 6-min walk test data assists in treatment decisions for patients with heart failure. BACKGROUND: In the SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial), a pre-specified subgroup analysis showed that patients with New York Heart Association functional class III symptoms did not benefit from implantable cardioverter-defibrillator (ICD) therapy and appeared to be harmed by amiodarone, whereas New York Heart Association functional class II patients obtained significant survival benefit from ICD. We postulated that a more objective measure of functional capacity, such as 6-min walk (6MW) distance, might provide a better tool for selecting these preventive therapies. METHODS: A 6MW test was performed before randomization in 2,397 patients. Median follow-up was 45.5 months. All-cause mortality was the primary endpoint, with cause-specific mortality (heart failure, arrhythmic) examined in secondary analyses. RESULTS: The hazard ratios (HRs) for ICD therapy compared to placebo were estimated within tertiles of baseline 6MW distance: HR: 0.42 (95% confidence interval [CI]: 0.26 to 0.66) for 6MW distance >386 m (top tertile); HR: 0.57 (95% CI: 0.39 to 0.83) for 6MW distance 288 to 386 m (middle tertile); and HR: 1.02 (95% CI: 0.75 to 1.39) for 6MW distance <288 m (bottom tertile). The corresponding HRs for amiodarone compared to placebo were 0.68 (95% CI: 0.46 to 1.02) for the top, 0.86 (95% CI: 0.61 to 1.21) for the middle, and 1.56 (95% CI: 1.17 to 2.09) for the bottom tertile. The 6MW distance was inversely related to heart failure-related mortality but not to arrhythmic mortality. ICD therapy reduced arrhythmic mortality in the top 2 tertiles of 6MW, but had no effect on heart failure mortality. CONCLUSIONS: A baseline 6MW distance <288 m identified a subgroup of SCD-HeFT patients who were harmed by amiodarone therapy and did not benefit from ICD. (Sudden Cardiac Death in Heart Failure Trial [SCD-HeFT]; NCT00000609).
Authors: Daniel J Friedman; Sana M Al-Khatib; Emily P Zeitler; JooYoon Han; Gust H Bardy; Jeanne E Poole; J Thomas Bigger; Alfred E Buxton; Arthur J Moss; Kerry L Lee; Richard Steinman; Paul Dorian; Riccardo Cappato; Alan H Kadish; Peter J Kudenchuk; Daniel B Mark; Lurdes Y T Inoue; Gillian D Sanders Journal: Am Heart J Date: 2017-06-09 Impact factor: 4.749
Authors: Kenji Matsumoto; Yi Xiao; Shunichi Homma; John L P Thompson; Richard Buchsbaum; Kazato Ito; Stefan D Anker; Min Qian; Marco R Di Tullio Journal: ESC Heart Fail Date: 2020-12-30
Authors: Selcuk Adabag; Tien N Vo; Lisa Langsetmo; John T Schousboe; Peggy M Cawthon; Katie L Stone; James M Shikany; Brent C Taylor; Kristine E Ensrud Journal: J Am Heart Assoc Date: 2018-05-04 Impact factor: 5.501