Mitral Valve Surgical Volume and Transcatheter Mitral Valve Repair Outcomes: Impact of a Proposed Volume Requirement on Geographic Access

BACKGROUND: There is an open Centers for Medicare and Medicaid Services National Coverage Decision for Transcatheter Mitral Valve Repair (TMVr) and a recent multisociety consensus document suggesting that TMVr centers should achieve pre-specified mitral valve replacement or repair (MVRr). Yet, little is known about the MVRr volume-TMVr outcome relationship. METHODS AND RESULTS: Using Centers for Medicare and Medicaid Services administrative claims from January 1, 2016 to December 31, 2018, we computed the Pearson correlation coefficient and performed multivariable hierarchical modeling to estimate the MVRr volume to TMVr outcome relationship for mortality and heart failure hospitalization. Additionally, we assessed the impact of the consensus recommendations on geographic access to care by hospital referral region. Total annualized MVRr volume was <11 to 1552 (median 96, interquartile range 53, 167). One-year survival, 1-year heart failure hospitalization after TMVr were not correlated with MVRr volume. After patient risk-adjustment for age, sex, and significant Elixhauser Comorbidities, there remained no significant correlation between institutional MVRr volume and 1-year mortality (estimate -0.010, SE 0.047, P=0.834) or heart failure hospitalization (estimate -0.011, SE 0.045, P=0.808) after TMVr. Raising the restriction on TMVr from 20 to 40 MVRr/y results in approximate to 30 million individuals having to travel outside of their hospital referral region to undergo TMVr, with a disproportionate impact in the Midwest and Southeast. CONCLUSIONS: There is no relationship between MVRr volumes and TMVr outcomes. Additionally, adoption of an annual MVRr volume >= 40 for performance of TMVr disproportionately impacts geographic access in the Midwest and Southeast and their large black and Hispanic populations.