Jadry Gruen1, Cesar Caraballo2, P Elliott Miller3, Megan McCullough1, Catherine Mezzacappa1, Neal Ravindra4, Clancy W Mullan5, Samuel W Reinhardt6, Makoto Mori7, Eric Velazquez6, Arnar Geirsson5, Tariq Ahmad8, Nihar R Desai9. 1. Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut. 2. Center for Outcomes Research and Evaluation, Yale University School of Medicine, New Haven, Connecticut. 3. Yale National Clinician Scholars Program, Yale University School of Medicine, New Haven, Connecticut; Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut. 4. Department of Biophysics and Biochemistry, Yale University School of Medicine, New Haven, Connecticut. 5. Section of Cardiac Surgery, Yale University School of Medicine, New Haven, Connecticut. 6. Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut. 7. Center for Outcomes Research and Evaluation, Yale University School of Medicine, New Haven, Connecticut; Section of Cardiac Surgery, Yale University School of Medicine, New Haven, Connecticut. 8. Center for Outcomes Research and Evaluation, Yale University School of Medicine, New Haven, Connecticut; Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut. 9. Center for Outcomes Research and Evaluation, Yale University School of Medicine, New Haven, Connecticut; Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut. Electronic address: nihar.desai@yale.edu.
Abstract
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.
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.
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