Abstract
Background The relevance of sex and preimplant factors for clinical outcomes among patients with left ventricular assist devices intended for destination therapy is unclear. Methods and Results INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) data (2006-2017) from 6771 men and 1690 women with left ventricular assist devices as destination therapy were analyzed to evaluate the contribution of preimplant clinical, demographic, and clinically judged psychosocial characteristics to time until death, heart transplant, device explant due to recovery, or complication-related device replacement. Associations of sex with time until each competing outcome were evaluated using cumulative incidence functions and event-specific Cox proportional hazards models. Women were younger, more likely to have nonischemic diagnoses, and reported less substance abuse but were more likely to be unmarried, not working for an income, overweight, and depressed than men. After 2 years, women had higher probabilities for recovery (3.7% versus 1.6%, P<0.001) and device replacement (12.1% versus 10%, P=0.019) than men but not for death and transplant (P>0.12). The sex differences remained after controlling for covariates (adjusted hazard ratio [HR(adj)] recovery, 1.85; 95% CI, 1.30-2.70; P<0.001; HR(adj) device replacement, 1.22; 95% CI, 1.04-1.33; P=0.015). Female-specific diagnoses (eg, postpartum heart failure) contributed to women's enhanced rate of recovery. Demographic and psychosocial factors were unrelated to women's increased event rates. Conclusions In destination therapy, women have higher rates of device replacement and recovery than men. The latter was partly explained by female-specific diagnoses. Standardized assessments of psychosocial characteristics are needed to elucidate their association with sex differences in outcomes.