Outcomes of Patients Designated Bridge to Candidacy (BTC) at Time of LVAD With and Without Psychosocial Risks Factors: Implications for CMS Coverage

Patients are designated destination therapy (DT) or bridge to transplant (BTT) at the time of LVAD implant. DT candidates with potentially modifiable medical or psychosocial risk factors that preclude immediate transplant listing are considered bridge to candidacy (BTC). A recent Centers for Medicare & Medicaid Services (CMS) national coverage determination (NCD) refused to expand coverage to de novo BTC patients, citing uncertainty in outcomes. We sought to compare outcomes including UNOS listing, transplant, and death on LVAD for BTT patients and DT/BTC patients with and without psychosocial risk factors. All patients designated DT/BTC and BTT at time of LVAD implant at a single institution between October 2004 and May 2013 were reviewed. Reasons for DT/BTC designation were categorized as medical, psychosocial, or both. 98/328 LVAD recipients (29.9%) were designated as DT/BTC: 66.3% (n=65) for medical reasons only, 33.7% (n=33) for at least one psychosocial reason. Overall, 43.9% (n=43) were eventually listed for transplant with 33.3% (31/93) receiving heart transplant. 112/328 (34.1%) LVAD recipients were designated BTT with 51% (57/122) receiving heart transplant. The mean time-to-listing for DT/BTC was 38 weeks. There was no statistical difference in rates of listing (p = 0.8329) or time-to-listing (p = 0.0527) between patients designated BTC with medical-only versus psychosocial reasons. Survival on LVAD was not significantly different (p=0.5195), between DT/BTC sub-groups with combined one-year survival at 74% and was also not significantly different from BTT with one-year survival on LVAD at 81% (p = 0.7651). Many patients with reversible risk factors do not meet criteria for immediate transplant listing or current DT criteria and therefore will not be covered for LVAD implantation by CMS. A significant proportion of BTC patients eventually achieve UNOS listing; most within the first year. There was also no difference in survival on support to transplant between patients initially designated BTC either for medical-only or psychosocial reasons when compared to BTT. This study suggests that almost 50% of BTC patients with or without psychosocial risk factors from our center will benefit from CMS coverage.