Artifactual declines in durable LVAD utilization among heart transplant candidates: Selection bias in transplant registries

BACKGROUND: The Organ Procurement and Transplantation Network (OPTN) Standard Transplant Analysis and Research (STAR) files are commonly used to study use of mechanical circulatory support (MCS) among heart transplant candidates. However, the STAR MCS file reports devices only for candidates removed from the waitlist, whereas the Scientific Registry of Transplant Recipients (SRTR) MCS file includes devices for all candidates. We compared the STAR and SRTR MCS files in estimating trends in LVAD support and waitlist outcomes among heart transplant candidates with durable LVADs. METHODS: We identified adult heart transplant candidates who obtained durable LVADs between October 18, 2018 and December 31, 2024 using MCS files from STAR (N = 4182) and SRTR (N = 4919). We estimated the cumulative incidence of transplantation and death/deterioration in both cohorts and analyzed LVAD prevalence at bimonthly intervals from October 2018 to April 2025. RESULTS: The SRTR cohort showed stable LVAD prevalence (30.7% to 37.4%). In contrast, the STAR cohort constructed from the MCS file showed a 92.5% decline in LVAD prevalence (1740 to 131 candidates), despite 971 candidates listed with status 4 for LVAD support on April 30, 2025. The STAR cohort demonstrated higher 3-year cumulative incidence of transplantation (66.7% vs 54.4%) and death/deterioration (10.1% vs 4.5%) after LVAD implantation. When we reran STAR-based analyses with both MCS and status justification files, prevalence and outcomes matched SRTR estimates. CONCLUSIONS: The STAR MCS file excludes LVADs among currently listed candidates, producing artifactual declines in LVAD prevalence and incidence and inflated waitlist outcomes. Awareness of registry construction is essential for accurate interpretation of LVAD-related outcomes.