Impact of the 2019 Low-Risk Indication Expansion on Transcatheter Aortic Valve Replacement Utilization, Outcomes, and Disparities: A National Interrupted Time Series Analysis

Abstract

In August 2019, the U.S. Food and Drug Administration extended the indication for transcatheter aortic valve replacement (TAVR) to low-surgical-risk patients with severe aortic stenosis. We evaluated the impact of this policy on national utilization, clinical outcomes, and access equity using an interrupted time series analysis of 81,142 unweighted TAVR hospitalizations (405,710 survey-weighted) from the National Inpatient Sample (2016-2022) across 2955 hospitals. The primary exposure was the third-quarter 2019 low-risk expansion, and the primary outcome was in-hospital mortality. Segmented linear regression measured level and slope changes at the policy inflection point; secondary analyses included Oaxaca-Blinder decomposition of racial mortality disparities and inverse probability of treatment weighting. Annual TAVR volume increased 134%, from 33,545 in 2016 to 78,405 in 2022, while mean patient age fell from 79.7 to 78.2 years, and the low-risk proxy prevalence tripled from 2.0% to 6.0%. In-hospital mortality declined from 1.58% to 0.84%, with a significant favorable postexpansion slope change ( P < 0.001); stroke, permanent pacemaker implantation, vascular complications, and length of stay also improved (all P < 0.001), whereas acute kidney injury was unchanged. Access increased modestly for racial minorities and lower-income patients. The 2019 low-risk expansion was associated with substantial volume growth, a shift toward younger, lower-acuity patients, and improved or stable outcomes, but emerging racial disparities warrant targeted surveillance.