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 ( TMV r) and a recent multisociety consensus document suggesting that TMV r centers should achieve prespecified mitral valve replacement or repair ( MVR r). Yet, little is known about the MVR r volume– TMV r 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 MVR r volume to TMV r 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 MVR r volume was <11 to 1552 (median 96, interquartile range 53, 167). One‐year survival, 1‐year heart failure hospitalization after TMV r were not correlated with MVR r volume. After patient risk‐adjustment for age, sex, and significant Elixhauser Comorbidities, there remained no significant correlation between institutional MVR r 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 TMV r. Raising the restriction on TMV r from 20 to 40 MVR r/y results in ≈30 million individuals having to travel outside of their hospital referral region to undergo TMV r, with a disproportionate impact in the Midwest and Southeast. Conclusions There is no relationship between MVR r volumes and TMV r outcomes. Additionally, adoption of an annual MVR r volume ≥40 for performance of TMV r disproportionately impacts geographic access in the Midwest and Southeast and their large black and Hispanic populations.