Author + information
- Received March 27, 2020
- Revision received April 7, 2020
- Accepted April 7, 2020
- Published online July 8, 2020.
- Jadry Gruen, MDa,
- Cesar Caraballo, MDb,
- P. Elliott Miller, MDc,d,
- Megan McCullough, MDa,
- Catherine Mezzacappa, MD, MPHa,
- Neal Ravindra, PhDe,
- Clancy W. Mullan, MDf,
- Samuel W. Reinhardt, MDd,
- Makoto Mori, MDb,f,
- Eric Velazquez, MDd,
- Arnar Geirsson, MDf,
- Tariq Ahmad, MD, MPHb,d and
- Nihar R. Desai, MD, MPHb,d,∗ ()
- aDepartment of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut
- bCenter for Outcomes Research and Evaluation, Yale University School of Medicine, New Haven, Connecticut
- cYale National Clinician Scholars Program, Yale University School of Medicine, New Haven, Connecticut
- dSection of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut
- eDepartment of Biophysics and Biochemistry, Yale University School of Medicine, New Haven, Connecticut
- fSection of Cardiac Surgery, Yale University School of Medicine, New Haven, Connecticut
- ↵∗Address for correspondence:
Dr. Nihar R. Desai, Cardiovascular Medicine, 15 York Street, P.O. Box 208017, New Haven, Connecticut 06520-8017.
Objectives This study sought to use INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) results to evaluate sex differences in the use and clinical outcomes of left ventricular assist devices (LVAD).
Background Despite a similar incidence of heart failure in men and women, prior studies have highlighted potential underuse of LVADs in women, and studies of clinical outcomes have yielded conflicting results.
Methods Patients were enrolled from the INTERMACS study who underwent implantation of their first continuous-flow LVAD between 2008 and 2017, and survival analyses stratified by sex were conducted.
Results Among the 18,868 patients, 3,984 (21.1%) were women. At 1 year, women were less likely to undergo heart transplantation than men (17.9% vs. 20.0%, respectively; p = 0.003). After multivariable adjustments, women had a higher risk of death (hazard ratio [HR]: 1.15; 95% confidence interval [CI]: 1.07 to 1.23; p < 0.001) and were more likely to incur post-implantation adverse events, including rehospitalization, bleeding, stroke, and pump thrombosis or device malfunction. Although women younger than 50 years of age had an increased risk of death compared to men of the same age (HR: 1.34; 95% CI: 1.12 to 1.6), men and women 65 years of age and older had a similar risk of death (HR: 1.09; 95% CI: 0.95 to 1.24).
Conclusions This study found that women had a higher risk of mortality and adverse events after LVAD. Only 1 in 5 LVADs were implanted in women, and women were less likely to receive a heart transplant than men. Further investigation is needed to understand the causes of adverse events and potential underuse of advanced treatment options in women.
Dr. Desai works under contract with the Centers for Medicare and Medicaid Services to develop and maintain performance measures used for public reporting and pay for performance programs; and he also received grant support and consulting fees for Amgen, Boehringer Ingelheim, and Cytokinetics and consulting fees for Relypsa, Novartis, and SCPharmaceuticals. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
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: Heart Failure author instructions page.
- Received March 27, 2020.
- Revision received April 7, 2020.
- Accepted April 7, 2020.
- 2020 American College of Cardiology Foundation
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