Sex-Associated Differences in the Clinical Outcomes of Left Ventricular Assist Device Recipients: Insights From Interagency Registry for Mechanically Assisted Circulatory Support

Abstract

Background: Sex-associated differences in clinical outcomes among left ventricular assist device recipients in the United States have been recognized. However, an investigation of the social and clinical determinants of sex-associated differences is lacking. Methods: Left ventricular assist device receiving patients enrolled in Interagency Registry for Mechanically Assisted Circulatory Support between 2005 and 2017 were included. The primary outcome was all-cause mortality. Secondary outcomes included heart transplantation and postimplantation adverse event rates. The cohort was stratified by the social subgroup of race and ethnicity (non-Hispanic White, non-Hispanic Black, non-Hispanic Asian, and Hispanic), and clinical subgroups of device strategy (destination therapy, bridge to transplant, and bridge to candidacy), and implantation center volume (low [≤20 implants/y], medium [21–30 implants/y], and high [>30 implants/y]). A multivariable-adjusted Cox proportional hazard model was used to assess the risk of death and heart transplantation with prespecified interaction testing. Poisson regression was used to estimate adverse events by sex across the various subgroups. Results: Among 18 525 patients, there were 3968 (21.4%) females. Compared with their male counterparts, Hispanic (adjusted hazard ratio [HR adj ], 1.75 [1.23–2.47]) females had the highest risk of death followed by non-Hispanic White females (HR adj , 1.15 [1.07–1.25]; P interaction =0.02). Hispanic (HR adj , 0.60 [0.40–0.89]) females had the lowest cumulative incidence of heart transplantation followed by non-Hispanic Black females (HR adj , 0.76 [0.67–0.86]), and non-Hispanic White females (HR adj , 0.88 [0.80–0.96]) compared with their male counterparts ( P interaction <0.001). Compared with their male counterparts, females on the bridge to candidacy strategy (HR adj , 1.32 [1.18–1.48]) had the highest risk of death ( P interaction =0.01). The risk of death ( P interaction =0.44) and cumulative incidence of heart transplantation ( P interaction =0.40) did not vary by sex in the center volume subgroup. A higher incidence rate of adverse events after left ventricular assist device implantation was also seen in females compared with the males, overall, and across all subgroups. Conclusions: Among left ventricular assist device recipients, the risk of death, the cumulative incidence of heart transplantation, and adverse events differ by sex across the social and clinical subgroups.

Righting a Wrong: Investigating Worse Right Ventricular Failure Observed in Women Undergoing LVAD Implantation

“…Despite a nearly equal distribution of heart failure between men and women, multiple studies have demonstrated decreased utilization of and worse outcomes after Left ventricular assist device (LVAD) implantation among women. 1,2 The current study by Lamba et al 3 furthers this finding, raising important questions about the role of pre- and postright ventricular failure in women undergoing LVAD implantation. Additionally, this study highlights the fundamental importance and a critical call to action with respect to equity in gender enrollment during clinical trials and retrospective studies.…”

The Influence of Arrhythmias and Metabolic Profile on Inpatient Mortality in Patients with Left Ventricular Assist Devices

“…Nevertheless, in contrast to the results reported by Joshi et al, the odds of death among females in our cohort were 1.4 times higher than that of males (95% CI: 1.25-1.59). Other more recent studies have reported similar results; in a 2023 retrospective cohort study that included nearly 20,000 LVAD recipients, Shetty et al found that females faced a significantly higher rate of adverse events and a higher risk of all-cause mortality relative to males across all sociodemographic subgroups [61]. The authors hypothesized that the outcome disparities could largely be attributed to social determinants of health, noting that females classically assume the role of caregiver, and thus females with HF are less likely to receive adequate family or spousal support and timely medical management [62].…”

Gender Effect on Clinical Profiles, Pharmacological Treatments and Prognosis in Patients Hospitalized for Heart Failure

“…The Momentum-3 trial, however, did not observe a significant interaction between gender groups in their prespecified subgroup analysis [89]. Conversely, an observational study focusing on LVAD recipients suggests that women face a higher risk of mortality, reduced likelihood of heart transplantation, and an increased rate of adverse events [90]. These disparities in clinical outcomes persist even when stratified by race, device strategy, or implantation center (Table 1).…”