Why the study?
In August 2019, the FDA expanded TAVR indications to low-surgical-risk patients, but the nationwide impact on utilization, clinical outcomes, and access equity needed evaluation.
Does the 2019 low-risk indication expansion for TAVR improve in-hospital mortality and utilization in patients undergoing TAVR?
Population
81,142 unweighted TAVR hospitalizations (405,710 survey-weighted) across 2955 hospitals
Comparison
Post-third-quarter 2019 low-risk expansion vs pre-expansion period
Design
National interrupted time series analysis
Key result
The 2019 low-risk indication expansion for TAVR was associated with a decline in in-hospital mortality from 1.58% to 0.84% (P<0.001).
Authors
Loading...
Policy expansion tied to higher TAVR volumes and stable or improved outcomes; leaves open equity surveillance for racial minorities.
Observational (n=81,142)
Yes
Does the 2019 low-risk indication expansion for TAVR improve in-hospital mortality and utilization in patients undergoing TAVR?
Absolute Event Rate: 0.84% vs 1.58%
p-value: p=<0.001
The 2019 FDA low-risk expansion for TAVR was associated with a 134% increase in procedural volume, a shift toward younger and lower-acuity patients, and significantly decreased in-hospital mortality.
Elkasaby et al. (2026) conducted an observational in severe aortic stenosis (n=81,142). 2019 low-risk indication expansion for TAVR vs. Pre-expansion period was evaluated on in-hospital mortality (p=<0.001). The 2019 low-risk indication expansion for TAVR was associated with a decline in in-hospital mortality from 1.58% to 0.84% (P<0.001).
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: