Adverse Events (AEs) After Left Ventricular Assist Device (LVAD) Implantation and Associated Psychosocial Risk Factors in Women

Abstract

<h3>Purpose</h3> Reasons for women's increased probability to experience AEs after LVAD implantation compared to men remain uncertain. The present analysis examined pre-implant psychosocial risk factors focusing on women. <h3>Methods</h3> We analyzed AEs in 19,984 patients (21.3% women), who received a primary continuous-flow LVAD between 7/2006 and 12/2017 and were enrolled in the INTERMACS. AEs considered were infection, neurological dysfunction, rehospitalization, respiratory failure, bleeding, device malfunction/ pump thrombosis, renal dysfunction and cardiac arrhythmia. Cumulative incidence functions were calculated for each AE including the competing outcomes death, heart transplant and device explant due to recovery. Event-specific Cox proportional hazard models were run, controlling for device-related factors, medical parameters, age and psychosocial factors (e.g., substance abuse, limited social support, severe depression, other major psychiatric diagnosis). <h3>Results</h3> Women were more likely than men to experience six out of the eight AEs. After 1 year, differences in women's and men's probability for AEs were most apparent for infection (44.4% in women vs. 39.2% in men, <i>p</i> < .001), neurological dysfunction (19.8% vs. 16.1%, <i>p</i> < .001) and rehospitalization (72.1% vs. 68.9%, <i>p</i> = .002). After multivariable adjustments, in women an increased rate of infection was associated with obesity and younger age. Rehospitalization was associated with major psychiatric diagnosis, smoking history, and younger age. Neurological dysfunction was associated with history of alcohol abuse [all HRs between 1.01 and 1.60, all <i>p</i> < .05]. <h3>Conclusion</h3> Women were more likely than men to experience AEs. We confirm previous findings by using an adequate competing risks approach for each AE separately. Each AE was specifically and independently associated with psychosocial factors. Substance abuse and younger age appear to be of particular relevance. These findings underline the importance of promoting: 1.) gender-sensitive research to shed more light on women's enhanced risk for AEs; 2.) rigorous assessment of psychosocial risk factors before LVAD implant. This is warranted to improve clinical practice for women.