Patients Receiving Durable LVADs at Centers without Transplant Are Less Likely to Undergo Transplant: An Analysis of the STS Intermacs Database

Abstract

<h3>Purpose</h3> CMS no longer requires assessment of transplant (TXP) eligibility from a Medicare-approved TXP center for patients receiving an LVAD at a non-TXP VAD-only center. The policy may have the unintended consequence of reducing access to TXP for patients receiving a VAD at non-TXP centers. We sought to determine if the availability of TXP at an LVAD implanting center impacted the probability of patients receiving a BTT LVAD and subsequent TXP prior to the policy change. <h3>Methods</h3> We used the STS Intermacs database to evaluate BTT listing and TXP among 22,221 LVAD recipients across 180 hospitals from 2012-2020. The outcomes of interest were 1. BTT at implant and 2. subsequent TXP by 2 years. The primary independent variable was TXP status designation (VAD-only vs. VAD/TXP center). Control variables included patient demographics, comorbidities, labs, hemodynamics, medications, and center-level variables that might influence listing strategy. Parameters for BTT listing were estimated using logistic regression with center-level random effects and for receipt of a TXP using a Cox model with the competing event of death. <h3>Results</h3> Of the 22,221 patients receiving an LVAD, 3,156 (14%) were implanted at VAD-only centers. A BTT strategy was used for 37.7% (n=7,186) and 16.9% (n=532) of patients implanted at VAD/TXP and VAD-only centers. TXP occurred in 22.1% (n=4,222) of patients at VAD/TXP centers and 9.9% (n=311) at VAD-only centers (Figure 1). Undergoing LVAD at a VAD-only center was associated with a 47% reduced adjusted odds of BTT LVAD designation (OR, 95% CI; 0.53, 0.40 - 0.70, p<0.0001) and a 27% reduction in receipt of a TXP (HR, 0.74, 0.65 - 0.83, p<0.0001) compared to VAD/TXP centers. <h3>Conclusion</h3> Receiving an LVAD at a VAD-only center was associated with reduced probability of BTT at implant and subsequent receipt of TXP at two years. The CMS policy change may have the unintended consequence of further reducing TXP access among patients receiving LVADs at non-TXP centers.