Author + information
- Received July 18, 2012
- Revision received January 2, 2013
- Accepted January 2, 2013
- Published online April 1, 2013.
- Jonathan P. Piccini, MD, MHS∗∗ (, )
- Anne S. Hellkamp, MS∗,
- David J. Whellan, MD†,
- Stephen J. Ellis, PhD∗,
- Steven J. Keteyian, PhD‡,
- William E. Kraus, MD∗,
- Adrian F. Hernandez, MD, MHS∗,
- James P. Daubert, MD∗,
- Ileana L. Piña, MD, MPH§,
- Christopher M. O’Connor, MD∗,
- HF-ACTION Investigators
- ↵∗Reprint requests and correspondence:
Dr. Jonathan P. Piccini, Electrophysiology Section and Duke Clinical Research Institute, Duke University Medical Center, PO Box 17969, Durham, North Carolina 27710.
Objectives The purpose of this study was to determine whether exercise training is associated with an increased risk of implantable cardioverter-defibrillator (ICD) therapy in patients with heart failure (HF).
Background Few data are available regarding the safety of exercise training in patients with ICDs and HF.
Methods HF-ACTION (Heart Failure and A Controlled Trial Investigating Outcomes of Exercise TraiNing) randomized 2,331 outpatients with HF and an ejection fraction (EF) ≤35% to exercise training or usual care. Cox proportional hazards modeling was used to examine the relationship between exercise training and ICD shocks.
Results We identified 1,053 patients (45%) with an ICD at baseline who were randomized to exercise training (n = 546) or usual care (n = 507). Median age was 61 years old, and median EF was 24%. Over a median of 2.2 years of follow-up, 20% (n = 108) of the exercise patients had a shock versus 22% (n = 113) of the control patients. A history of sustained ventricular tachycardia/fibrillation (hazard ratio [HR]: 1.93 [95% confidence interval (CI): 1.47 to 2.54]), previous atrial fibrillation/flutter (HR: 1.63 [95% CI: 1.22 to 2.18]), exercise-induced dysrhythmia (HR: 1.67 [95% CI: 1.23 to 2.26]), lower diastolic blood pressure (HR for 5-mm Hg decrease <60: 1.35 [95% CI: 1.12 to 1.61]), and nonwhite race (HR: 1.50 [95% CI: 1.13 to 2.00]) were associated with an increased risk of ICD shocks. Exercise training was not associated with the occurrence of ICD shocks (HR: 0.90 [95% CI: 0.69 to 1.18], p = 0.45). The presence of an ICD was not associated with the primary efficacy composite endpoint of death or hospitalization (HR: 0.99 [95% CI: 0.86 to 1.14], p = 0.90).
Conclusions We found no evidence of increased ICD shocks in patients with HF and reduced left ventricular function who underwent exercise training. Exercise therapy should not be prohibited in ICD recipients with HF. (Exercise Training Program to Improve Clinical Outcomes in Individuals With Congestive Heart Failure; NCT00047437)
The HF-ACTION trial was funded by National Institutes of Health grant 5U01HL063747 to Dr. O’Connor, RU01HL066482 to Dr. Pina, and 5UO1HL06694 to Dr. Keteyian. This analysis was funded by a grant from Boston Scientific to Drs. Piccini, Whellan, and O’Connor. Dr. Piccini received grants for clinical research from Johnson & Johnson and serves as a consultant to Johnson & Johnson, Forest Laboratories, Medtronic, and Sanofi-Aventis. Dr. Hernandez received research support from Johnson & Johnson (Scios, Inc.), Amylin, and Proventys and honoraria from Corthera. The content of this report is solely the responsibility of the authors and does not necessarily represent the official views of the National Heart, Lung, and Blood Institute or NIH. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received July 18, 2012.
- Revision received January 2, 2013.
- Accepted January 2, 2013.
- American College of Cardiology Foundation