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The Journal of Heart and Lung Transplantation
International Society for Heart and Lung Transplantation.

Sex-Based Outcomes After Implantation of a Fully Magnetically Levitated Left Ventricular Assist Device

      Purpose

      Left ventricular assist devices (LVAD) remain underutilized in females and therefore poorly studied in relation to biological sex. Whether outcomes vary by sex after implantation of a fully magnetically levitated LVAD implantation remains uncertain.

      Methods

      In this analysis, MOMENTUM 3 study data was utilized (pivotal randomized clinical trial and continued access protocol) and adjusted for age (>65 years), body mass index (>30 kg/m2), race, ischemic cardiomyopathy, INTERMACS profile (>2), history of stroke or diabetes, bilirubin, albumin, and estimated GFR. Survival free of disabling stroke or reoperation to replace or remove a malfunctioning device at 2 years was compared by sex (primary endpoint). Overall survival, major adverse events (calculated as events per 100 patient-years), and quality of life (QOL) using EQ-5D-5L visual analogue scale (VAS) scores were also compared.

      Results

      Of 2,200 HeartMate 3TM LVAD patients, 448 (20.4%) were female and 1,752 (79.6%) were male. Relative to males, females implanted with HeartMate 3 were younger, more likely to be a Black person and have a non-ischemic cardiomyopathy. There was no difference in the primary endpoint (female: 81.0% vs. male: 77.4%; HR 0.98 [0.76-1.25], p=0.84). Overall survival at 2 years was similar (female 83.9% vs. male: 81.8%; HR 1.08 [0.82-1.41], p=0.60 (Figure 1A). Females were at higher risk of adverse events, driven by stroke (8.3 vs. 6.4; p=0.011), bleeding (77.4 vs. 66.1; p<0.001), and infection (85.7 vs. 72.0; p=0.011), however, males had more arrhythmia (32.4 vs 27.2; p=0.042) (Figure 1B). QOL measurement gains were similar.

      Conclusion

      Females have similar survival as males in this contemporary LVAD cohort, although major adverse events are increased including stroke, bleeding, and infection. Further work is needed to understand disparity by sex in device implantation, mechanisms of adverse events, and response to medical management.