Author + information
- Received July 27, 2019
- Revision received May 24, 2020
- Accepted May 28, 2020
- Published online July 20, 2020.
- Jeanne E. Poole, MDa,∗ (, )@jepoolemd,
- Brian Olshansky, MDb,
- Daniel B. Mark, MD, MPHc,
- Jill Anderson, RNd,
- George Johnson, BSEEd,
- Anne S. Hellkamp, MSe,
- Linda Davidson-Ray, MAc,
- Daniel P. Fishbein, MDa,
- Robin E. Boineau, MD, MAf,
- Kevin J. Anstrom, PhDe,
- Per G. Reinhall, PhDg,
- Douglas L. Packer, MDh,
- Kerry L. Lee, PhDe,
- Gust H. Bardy, MDi,
- for the SCD-HeFT Investigators
- aDepartment of Medicine, Division of Cardiology, University of Washington, Seattle, Washington
- bDepartment of Medicine, Division of Cardiology, University of Iowa, Iowa City, Iowa
- cDepartment of Medicine, Division of Cardiology, Duke University, Durham, North Carolina
- dSeattle Institute for Cardiac Research, Seattle, Washington
- eDepartment of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina
- fNational Center for Complementary and Integrative Health, National institutes of Health, Bethesda, Maryland
- gDepartment of Mechanical Engineering, University of Washington, Seattle, Washington
- hDepartment of Cardiology, Division of Cardiac Electrophysiology, Mayo Clinic, Rochester, Minnesota
- iDepartment of Medicine, Division of Cardiology, Seattle Institute for Cardiac Research, Seattle, Washington
- ↵∗Address for correspondence:
Dr. Jeanne E. Poole, University of Washington Medical Center, 1959 NE Pacific Street, Box 356422, Seattle, Washington 98195.
Background The SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial) randomized 2,521 patients with moderate heart failure (HF) to amiodarone, placebo drug, or implantable cardioverter-defibrillator (ICD) therapy. Original trial follow-up ended October 31, 2003. Over a median 45.5-month follow-up, amiodarone, compared with placebo, did not affect survival, whereas randomization to an ICD significantly decreased all-cause mortality by 23%.
Objectives This study sought to describe the extended treatment group survival of the SCD-HeFT cohort.
Methods Mortality outcomes for the 1,855 patients alive at the end of the SCD-HeFT trial were collected between 2010 and 2011. These data were combined with the 666 deaths from the original study to compare long-term outcomes overall and for key pre-specified subgroups.
Results Median (25th to 75th percentiles) follow-up was 11.0 (10.0 to 12.2) years. On the basis of intention-to-treat analysis, the ICD group had overall survival benefit versus placebo drug (hazard ratio [HR]: 0.87; 95% confidence interval [CI]: 0.76 to 0.98; p = 0.028). When treatment benefit was examined as a function of time from randomization, attenuation of the ICD benefit was observed after 6 years (p value for the interaction = 0.0015). Subgroup analysis revealed long-term ICD benefit varied according to HF etiology and New York Heart Association (NYHA) functional class: ischemic HF HR: 0.81; 95% CI: 0.69 to 0.95; p = 0.009; nonischemic HF HR: 0.97; 95% CI: 0.79 to 1.20; p = 0.802; NYHA functional class II HR: 0.76; 95% CI: 0.65 to 0.90; p = 0.001; NYHA functional class III HR: 1.06; 95% CI: 0.86 to 1.31; p = 0.575.
Conclusions Follow-up of SCD-HeFT patients to 11 years demonstrated heterogenous treatment-related patterns of long-term survival with ICD benefit most evident at 11 years for ischemic HF patients and for those with NYHA functional class II symptoms at trial enrollment. (SCD-HeFT 10 Year Follow-up [SCD-HeFT10 Yr]; NCT01058837)
This work was funded by National Heart, Lung, and Blood Institute National Institutes of Health (American Recovery and Reinvestment Act of 2009), with a subsidiary grant from St. Jude Medical Corporation. Dr. Poole has received institutional research support from Medtronic, Biotronik, AtriCure, and Kestra, Inc.; has been a speaker for Boston Scientific, Medtronic, and MediaSphere Medical, LLC; has served on an Advisory Board for Boston Scientific; has served on a study committee for Medtronic; has served on a data and safety monitoring board for EBR Systems; has received royalties from Elsevier; and has received compensation from the Heart Rhythm Society for serving as Editor-in-Chief for the Heart Rhythm O2 journal. Dr. Olshansky has been a consultant for Lundbeck, Amarin, Respicardia, Respironics, and Sanofi; has served on a data and safety monitoring board for Amarin; has been a trial coordinator for Boehringer Ingelheim; and has been a speaker for Lundbeck. Dr. Mark has received grants from the National Institutes of Health/National Heart, Lung, and Blood Institute (NIH/NHLBI [UO1 HL55496]) and Mayo Clinic, Merck, Oxygen Therapeutics, and HeartFlow, outside the submitted work; and has been a consultant for CeleCor, Cytokinetics, and NovoNordisk, outside the submitted work. Dr. Packer has provided consulting services without reimbursement for Abbott, Biosense-Webster, Boston Scientific, Medtronic, Siemens, SigNum Preemptive Healthcare, Inc., Spectrum Dynamics, Johnson and Johnson, and Thermedical; has provided consulting services with modest reimbursement for Biotronik and MediaSphere Medical LLC.; receives funding from Abbott, Biosense Webster, Boston Scientific/EPT, CardioInsight, CardioFocus, Endosense, German Heart Foundation, Hansen Medical, Medtronic, NIH, Robertson Foundation, St. Jude Medical, Siemens, and Thermedical; with Mayo Clinic has a financial interest in mapping technologies with St. Jude Medical; with Mayo Clinic has a financial interest in Analyze-AVW technology with royalties awarded to the institution (Mayo Clinic); and with his institution holds equity in External Beam Ablation Medical Devices, from Wiley & Sons, Oxford. Dr. Lee has received grants from NIH/NHLBI (UO1 HL55297) and Mayo Clinic, outside the submitted work; and has served on data and safety monitoring boards for Merck, AstraZeneca, and Medtronic, outside the submitted work. Dr. Bardy has received grants UO1 HL55766 and RC01-1HL 100625-01. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Eric Stecker, MD, served as Guest Associate Editor for this paper. Deepak L. Bhatt, MD, MPH, served as Guest Editor-in-Chief for this paper.
The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC author instructions page.
- Received July 27, 2019.
- Revision received May 24, 2020.
- Accepted May 28, 2020.
- 2020 American College of Cardiology Foundation
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