Sex Associated Differences in the Clinical Outcomes of Left Ventricular Assist Device Recipients: Insights from INTERMACS

• Type of Material: Article
• Authors: Naman S. Shetty, University of Alabama at Birmingham; Vibhu Parcha, University of Alabama at Birmingham; Peter Abdelmessih, University of Alabama at Birmingham; Nirav Patel, University of Alabama at Birmingham; Ammar A. Hasnie, University of Alabama at Birmingham; Rajat Kalra, University of Minnesota, Minneapolis; Ambarish Pandey, University of Texas Southwestern; Khadijah Breathett, Indiana University, Indianapolis; Alanna A. Morris, Emory University; Garima Arora, University of Alabama at Birmingham; Pankaj Arora, University of Alabama at Birmingham
• Language: English
• Date: 2023-05-26
• Publisher: Wolters Kluwer Health, Inc.
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: © 2023, Wolters Kluwer Health
• Final Published Version (URL): https://doi.org/10.1161/CIRCHEARTFAILURE.122.010189
• Title of Journal or Parent Work: Circulation: Heart Failure
• Volume: 16
• Issue: 6
• Start Page: e010189
• Grant/Funding Agency: National Institutes of Health; Doris Duke Charitable Foundation
• Grant/Funding Information: Dr. Pankaj Arora is supported by the National Heart, Lung, And Blood Institute of the National Institutes of Health (NIH) awards R01HL160982, R01HL163852, R01HL163081, and K23HL146887, and by the Doris Duke Charitable Foundation COVID-19 Fund to Retain Clinician Scientists (Grant #2021255); UAB COVID-19 CARES Retention Program (CARES at UAB). Dr. Breathett has research funding from National Heart, Lung, and Blood Institute (NHLBI) K01HL142848, R01HL159216, R56HL159216, and L30HL148881.
• Keywords: Left Ventricular Assist Device; Mortality; INTERMACS; Sex; Heart Transplant; Heart Failure
• Subject - Topics: Cardiology; Transplantation of organs, tissues, etc.

Abstract

Background: Sex-associated differences in clinical outcomes among left ventricular assist device(LVAD) recipients in the US have been recognized. However, an investigation of the social and clinical determinants of sex-associated differences is lacking. Methods: LVAD receiving patients enrolled in INTERMACS between 2005–2017 were included. The primary outcome was all-cause mortality. Secondary outcomes included heart transplantation and post-implantation 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/year), medium(21–30 implants/year), and high(>30 implants/year)]. A multivariable-adjusted Cox proportional hazard model was used to assess the risk of death and heart transplantation with pre-specified interaction testing. Poisson regression was used to estimate adverse events by sex across the various subgroups. Results: Among 18,525 patients, there were 3,968(21.4%) females. Compared with their male counterparts, Hispanic[HRadj:1.75(1.23–2.47)] females had the highest risk of death followed by non-Hispanic White females [HRadj:1.15(1.07–1.25)](Pinteraction:0.02). Hispanic[HRadj:0.60(0.40–0.89)] females had the lowest cumulative incidence of heart transplantation followed by non-Hispanic Black females[HRadj:0.76(0.67–0.86)], and non-Hispanic White females[HRadj:0.88(0.80–0.96)] compared with their male counterparts(Pinteraction:<0.001). Compared with their male counterparts, females on the bridge to candidacy strategy[HRadj:1.32(1.18–1.48)] had the highest risk of death(Pinteraction:0.01). The risk of death(Pinteraction:0.44) and cumulative incidence of heart transplantation(Pinteraction:0.40) did not vary by sex in the center volume subgroup. A higher incidence rate of adverse events post-LVAD implantation was also seen in females compared with the males, overall, and across all sub-groups. Conclusions: Among LVAD recipients, the risk of death, the cumulative incidence of heart transplantation, and adverse events differ by sex across the social and clinical subgroups.