Psychosocial and demographic predictors of clinical outcomes in male and female recipients of left ventricular assist devices

点击翻译按钮获取中文摘要

In the next two decades, cardiovascular diseases, especially heart failure, are expected to increase dramatically in persons >65 years of age in Germany and worldwide. Studies of cardiac patients have shown that psychosocial stress-related factors, in particular social isolation, low socioeconomic status, and depression, are related to poor prognosis, independent of disease severity. However, little is known about the contribution of these factors to prognosis in the increasing number of patients with advanced heart failure, who are receiving treatment with left ventricular assist devices (LVAD). These devices, that are implanted without age restriction, can prolong survival, but often come at the cost of adverse clinical events such as internal bleeding, infection, or neurological complications (stroke). It is unknown whether psychosocial stress-related factors contribute to the sex difference (favouring men) in mortality and adverse events post-LVAD that has been observed in several studies. Also, the role of a higher age at time of LVAD implantation for clinical outcomes is unclear. To close this knowledge gap, we will analyse data from >16,000 (21% female) adult continuous flow LVAD recipients of varying age groups, who were enrolled into the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) database between June 2006 and June 2017. We will describe pre-operatively assessed psychosocial stress-related characteristics in men and women of different age groups. We will examine whether these characteristics contribute to an impaired prognosis in men and women after LVAD implantation. Specifically, we will apply survival analyses to investigate the associations of psychosocial risk (being unmarried as a functional measure of social isolation, low educational attainment, depression/anxiety) and of medical risk and other risk factors (e.g., indicators of disease severity, co-morbidities, smoking) with clinical outcomes. We will analyses the time until the first occurrence of events such as death, device explant due to recovery, or adverse events such as bleeding, infection, or stroke. These analyses will be carried out in a competing risks approach, because events such as an infection might change the risk for death. We will also examine whether the above relationships with psychosocial factors are similar for men and women, and whether age is of relevance for these associations. EUROMACS, a comparable European registry with German participation, has only started to collect patient data in 2012, but will provide large datasets in the future. Thus, together with experts from the INTERMACS and from EUROMACS we will conduct a workshop to develop strategies for collaborative registry research to advance the field of psychosocial factors in LVAD implantation. This may aid the development of interventions aimed at improving outcomes after LVAD implants in the growing population of patients with heart failure.