Lisa-Marie Maukel

• Left ventricular assist devices (LVADs) have become a valuable treatment for patients with advanced heart failure. Women appear to be disadvantaged in the usage of LVADs and concerning clinical outcomes such as death and adverse events after LVAD implant. Contrary to typical clinical characteristics (e.g., disease severity), device-related factors such as the intended device strategy, bridge to a heart transplantation or destination therapy, are often not considered in research on gender differences. In addition, the relevance of pre-implant psychosocial risk factors, such as substance abuse and limited social support, for LVAD outcomes is currently unclear. Thus, the aim of this dissertation is to explore the role of pre-implant psychosocial risk factors for gender differences in clinical outcomes, accounting for clinical and device-related risk factors. In the first article, gender differences in pre-implant characteristics of patients registered in The European Registry for Patients with Mechanical Circulatory Support (EUROMACS) were investigated. It was found that women and men differed in multiple pre-implant characteristics depending on device strategy. In the second article, gender differences in major clinical outcomes (i.e., death, heart transplant, device explant due to cardiac recovery, device replacement due to complications) were evaluated for patients in the device strategy destination therapy in the Interagency Registry for Mechanically Assisted Circulation (INTERMACS). Additionally, the association of gender and psychosocial risk factors with the major outcomes were analyzed. Women had similar probabilities to die on LVAD support, and even higher probabilities to experience explant of the device due to cardiac recovery compared with men in the destination therapy subgroup. Pre-implant psychosocial risk factors were not associated with major outcomes. The third article focused on gender differences in 10 adverse events (e.g., device malfunction, bleeding) after LVAD implant in INTERMACS. The association of a psychosocial risk indicator with gender and adverse events after LVAD implantation was evaluated. Women were less likely to have psychosocial risk pre-implant but more likely to experience seven out of 10 adverse events compared with men. Pre-implant psychosocial risk was associated with adverse events, even suggesting a dose response-relationship. These associations appeared to be more pronounced in women. In conclusion, women appear to have similar survival to men when accounting for device strategy. They have higher probabilities of recovery, but higher probabilities of device replacement and adverse events compared with men. Regarding these adverse events, women may be more susceptible to psychosocial risk factors than men. The results of this dissertation illustrate the importance of gender-sensitive research and suggest considering device strategy when studying gender differences in LVAD recipients. Further research is warranted to elucidate the role of specific psychosocial risk factors that lead to higher probabilities of adverse events, to intervene early and improve patient care in both, women and men