Author + information
- Received April 7, 2014
- Revision received August 11, 2014
- Accepted September 2, 2014
- Published online February 1, 2015.
- Emily P. Zeitler, MD∗,†,
- Anne S. Hellkamp, MS†,
- Gregg C. Fonarow, MD‡,
- Stephen C. Hammill, MD§,
- Lesley H. Curtis, PhD†,
- Adrian F. Hernandez, MD, MHS∗,†,
- Hussein R. Al-Khalidi, PhD†,
- Jeptha P. Curtis, MD‖,
- Paul A. Heidenreich, MD¶,
- Kevin J. Anstrom, PhD†,
- Eric D. Peterson, MD, MPH∗,†,
- Daniel B. Mark, MD, MPH∗,†,
- Bradley G. Hammill, MS∗,
- Gillian D. Sanders, PhD† and
- Sana M. Al-Khatib, MD, MHS∗,†∗ ()
- ∗Duke Clinical Research Institute, Durham, North Carolina
- †Duke University Medical Center, Department of Medicine, Division of Cardiology, Durham, North Carolina
- ‡Ahmanson-UCLA Cardiomyopathy Center, Ronald Reagan-UCLA Medical Center, Los Angeles, California
- §Mayo Clinic, Rochester, Minnesota
- ‖Section of Cardiovascular Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut
- ¶VA Palo Alto Health Care System, Palo Alto, California
- ↵∗Reprint requests and correspondence:
Dr. Sana M. Al-Khatib, Duke Clinical Research Institute, PO Box 17969, Durham, North Carolina 27715.
Objectives The purpose of this study was to assess the benefit of primary prevention implantable cardioverter defibrillators (ICDs) in women.
Background Clinical trials of primary prevention ICDs enrolled a limited number of women.
Methods Using a propensity score method, we matched 490 women ≥65 years of age who received an ICD during a hospitalization for heart failure in the National Cardiovascular Data Registry ICD Registry from January 1, 2006, through December 31, 2007, to 490 ICD-eligible women without an ICD hospitalized for heart failure in the Get With The Guidelines for Heart Failure database from January 1, 2006, through December 31, 2009. The primary endpoint was all-cause mortality obtained from the Medicare Claims Database. An identical analysis was conducted in men.
Results Median follow-up for patients with an ICD was 4.6 years versus 3.2 years for patients with no ICD. Compared with women with no ICD, those with an ICD were younger and less frequently white. In the matched cohorts, the survival of women with an ICD was significantly longer than that of women without an ICD (adjusted hazard ratio: 0.79, 95% confidence interval: 0.66 to 0.95; p = 0.013). Similarly, men with an ICD had longer survival than men without an ICD (adjusted hazard ratio: 0.73, 95% confidence interval: 0.65 to 0.83; p < 0.0001). There was no interaction between sex and the presence of an ICD with respect to survival (p = 0.44).
Conclusions Among older women with left ventricular dysfunction, a primary prevention ICD was associated with a significant survival benefit that was nearly identical to that seen in men. These findings support the use of primary prevention ICDs in eligible patients regardless of sex.
This analysis was funded by a grant (1R01-HL093071-01A1) from the National Heart, Lung, and Blood Institute (NHLBI). The NHLBI had no role in the design or conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript. The manuscript was reviewed by the American Heart Association-Get With The Guidelines (AHA-GWTG) and the American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR) ICD Registry Research and Publications Committee. Views expressed in this paper are those of the authors and do not necessarily represent the official view of the NHLBI, AHA-GWTG, or the ACC-NCDR. Dr. Fonarow has received research funding from the Agency for Healthcare Research and Quality and the National Institutes of Health; and has served as a consultant to Novartis, Medtronic, Gambro, Johnson & Johnson, The Medicines Company, and Bayer HealthCare. Dr. L. Curtis has received research funding from Johnson & Johnson, Novartis, GE Healthcare, Boston Scientific, and GlaxoSmithKline. Dr. Hernandez has received support from Medtronic and Boston Scientific. Dr. Al-Khalidi is on the Data and Safety Monitoring Board for Duke University. Dr. J. Curtis receives salary support under contract with the American College of Cardiology to provide data analytic services; and holds stock in Medtronic. Dr. Anstrom has received research support from AstraZeneca, Eli Lilly and Company, and Medtronic; and has served as a consultant for Abbott Vascular, AstraZeneca, Bristol-Myers Squibb, Pfizer, and Ikaria. Dr. Peterson receives funding from Janssen, Eli Lilly and Company, and Boehringer Ingelheim. Dr. Mark has received grant funding from the National Institutes of Health, Eli Lilly and Company, and AstraZeneca; grants and personal fees from Gilead Sciences, Inc.; personal fees from Janssen; and funding from Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. John R. Teerlink, MD, has served as Guest Editor for this paper.
- Received April 7, 2014.
- Revision received August 11, 2014.
- Accepted September 2, 2014.
- American College of Cardiology Foundation