Author + information
- Received December 2, 2018
- Revision received February 15, 2019
- Accepted February 17, 2019
- Published online May 8, 2019.
- Garrick C. Stewart, MD, MPHa,∗ (, )@StewartGarrick,
- Thomas Cascino, MDb,
- Blair Richards, MPHc,
- Shokoufeh Khalatbari, MSc,
- Douglas L. Mann, MDd,
- Wendy C. Taddei-Peters, PhDe,
- J. Timothy Baldwin, PhDe,
- Neal O. Jeffries, PhDe,
- Catherine Spino, ScDf,
- Lynne W. Stevenson, MDg,
- Keith D. Aaronson, MD, MSb,
- for the REVIVAL Investigators
- aBrigham and Women’s Hospital, Boston, Massachusetts
- bUniversity of Michigan, Ann Arbor, Michigan
- cUniversity of Michigan, Michigan Institute for Clinical and Health Research, Ann Arbor, Michigan
- dWashington University School of Medicine, St. Louis, Missouri
- eNational Institutes of Health, Bethesda, Maryland
- fUniversity of Michigan School of Public Health, Ann Arbor, Michigan
- gVanderbilt University Medical Center, Nashville, Tennessee
- ↵∗Address for correspondence:
Dr. Garrick C. Stewart, Division of Cardiovascular Medicine, Brigham and Women’s Hospital, 75 Francis Street, Boston, Massachusetts 02115.
Objectives This study sought to explore clinical characteristics and outcomes in women and men with ambulatory advanced heart failure (HF).
Background Women have been underrepresented in studies of advanced HF and have an increased mortality on the transplant waiting list and early after mechanical circulatory support (MCS). An increased understanding of the differential burden of HF between women and men is required to inform the use of mechanical circulatory support in ambulatory advanced HF patients.
Methods REVIVAL (Registry Evaluation for Vital Information on Ventricular Assist Devices in Ambulatory Life) is a prospective, observational study of 400 outpatients with chronic systolic HF, New York Heart Association functional class II to IV, and 1 additional high-risk feature. Clinical characteristics, quality of life, and functional capacity were compared between women and men, as was a primary composite endpoint of death, durable MCS, or urgent heart transplantation at 1 year.
Results REVIVAL enrolled 99 women (25% of the cohort) who had similar age, ejection fraction, INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) profiles, medication use, and willingness to consider MCS as the men enrolled; however, women reported significantly greater limitations in quality of life with respect to physical limitation, reduced 6-min walk distance, and more frequent symptoms of depression. Nevertheless, 1-year combined risk of death, durable MCS, or urgent transplantation did not differ between women and men (24% vs. 22%; p = 0.94).
Conclusions This study represents the largest report to date of women with ambulatory advanced HF receiving contemporary therapies. Systematic elicitation of patient-reported outcome measures uncovered an added burden of HF in women and may be an appropriate target of augmented support and intervention.
This research was supported by funding from the National Institutes of Health, National Heart, Lung, and Blood Institute (contract number HHSN268201100026C) and the National Center for Advancing Translational Sciences (grant number UL1TR002240) for the Michigan Institute for Clinical and Health Research. The views expressed in this manuscript are those of the authors and do not necessarily represent the views of the National Heart, Lung, and Blood Institute; the National Institutes of Health; or the U.S. Department of Health and Human Services. Dr. Aaronson has received research support from Medtronic and Abbott; and has served as a consultant for Procyrion and NuPulseCV. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received December 2, 2018.
- Revision received February 15, 2019.
- Accepted February 17, 2019.
- 2019 American College of Cardiology Foundation
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