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

未来二十年，预计德国和全球65岁以上人群的心血管疾病（尤其是心力衰竭）将急剧增加。对心脏病患者的研究表明，社会心理压力相关因素，特别是社会孤立、社会经济地位低下和抑郁症，与预后不良有关，与疾病严重程度无关。然而，很少有人知道这些因素对预后的贡献越来越多的晚期心力衰竭患者，谁正在接受左心室辅助装置（LVAD）的治疗。这些植入无年龄限制的设备可以延长生存期，但通常以不良临床事件为代价，如内出血，感染或神经系统并发症（中风）。目前尚不清楚心理社会压力相关因素是否会导致几项研究中观察到的LVAD后死亡率和不良事件的性别差异（男性更有利）。此外，LVAD植入时较高年龄对临床结局的作用尚不清楚。为了弥补这一知识差距，我们将分析2006年6月至2017年6月期间纳入机械辅助循环支持机构间登记（INTERMACS）数据库的不同年龄组的> 16，000名（21%女性）成人连续流LVAD接受者的数据。我们将描述术前评估的不同年龄组的男性和女性的心理社会压力相关特征。我们将研究这些特征是否有助于左心室辅助装置植入后的男性和女性预后受损。具体来说，我们将应用生存分析来调查社会心理风险（未婚作为社会孤立、低教育程度、抑郁/焦虑的功能性衡量标准）和医疗风险与其他风险因素（例如，疾病严重程度、合并症、吸烟的指标）与临床结果。我们将分析直至首次发生事件（如死亡、因恢复而取出器械）或不良事件（如出血、感染或卒中）的时间。这些分析将采用竞争风险方法进行，因为感染等事件可能会改变死亡风险。我们还将研究上述与心理社会因素的关系是否对男性和女性相似，以及年龄是否与这些协会有关。EUROMACS是一个由德国参与的可比欧洲登记系统，2012年才开始收集患者数据，但未来将提供大型数据集。因此，我们将与INTERMACS和EUROMACS的专家一起举办研讨会，为合作登记研究制定策略，以推进LVAD植入的心理社会因素领域。这可能有助于开发旨在改善日益增长的心力衰竭患者LVAD植入后结局的干预措施。

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.