Adverse events after left ventricular assist device implantation linked to psychosocial risk in women and men.

BACKGROUND: Reasons for women's increased probability to experience adverse events (AEs) after left ventricular assist device (LVAD) implantation compared with men's remain uncertain. We explored the role of psychosocial risk in the experience of AEs in women and men. METHODS: INTERMACS patients receiving a primary continuous-flow LVAD between July 2006 and December 2017, median follow-up 13.6 months, were included (n = 20,123, 21.3% women). Time-to-event was calculated with cumulative incidence functions for 10 types of AEs separately (e.g., infection, device malfunction), each time accounting for the competing outcomes death, heart transplant, and device explant due to recovery. Event-specific Cox proportional hazard models were run with a binary psychosocial risk variable (including substance abuse, psychiatric diagnosis, limited social support, limited cognition, repeated noncompliance), controlled for covariates. RESULTS: Psychosocial risk was more prevalent in men than in women (21.4% vs 17.5%, p < 0.001). Seven out of 10 AEs were more likely in women than in men (e.g., infection 44.5% vs 39.2%, p < 0.001). The association of psychosocial risk with each AE was either stronger in women than in men (e.g., device malfunction HRadj 1.29, 95% confidence interval (CI) (1.06-1.56) vs HRadj 1.10, 95% CI (0.97-1.25); rehospitalization HRadj 1.15, 95% CI (1.02-1.29) vs HRadj 1.03, 95% CI (0.97-1.10) or similar between sexes. CONCLUSIONS: Independent of clinical parameters, the presence of psychosocial risk is associated with increases in AEs. This suggests that early modification of psychosocial risk factors may have the potential to lower the risk for AEs in this patient population.

Sex Differences in Recovery and Device Replacement After Left Ventricular Assist Device Implantation as Destination Therapy.

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 [HRadj] recovery, 1.85; 95% CI, 1.30-2.70; P<0.001; HRadj 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.

Gender differences in psychosocial and clinical characteristics in the European Registry for Patients with Mechanical Circulatory Support.

BACKGROUND: Not much is known about psychosocial characteristics of men and women receiving continuous flow left ventricular assist devices (CF LVAD). OBJECTIVE: To investigate gender differences in clinical and psychosocial (demographic, behavioral, psychological) characteristics in CF LVAD recipients. METHODS: We analyzed European Registry for Patients with Mechanical Circulatory Support (EUROMACS) data (N=2395, 16.8% women; 2011 to 2017) and compared pre-implant characteristics in men and women intended for bridge-to-transplant (BTT) or destination therapy (DT). RESULTS: Women were underrepresented [DT (n=61): 13.4%; BTT (n=341): 17.6%]. They were more likely to be divorced/separated, widowed, in unstable clinical condition, and non-working (DT only), but less likely to be smokers, to have ischemic cardiomyopathy or diabetes, and younger (BTT only) than men. Missing data were abundant, especially those that reflect psychological characteristics (>87%). CONCLUSION: Gender differences were noted, some specific to device strategy. Improved collection of psychosocial characteristics is warranted to elucidate their relationship to future prognosis.