Transcatheter aortic valve replacement (TAVR) was first approved by the U.S. Food and Drug Administration in 2011 for patients with prohibitive risk of surgery. Since then, the procedure has steadily gained new indications and become increasingly common.
In 2012, the FDA expanded the indication to include patients at high surgical risk and added those at intermediate risk in 2016. In 2019, the agency included low-risk patients in the approved population.[i]
As the indications for TAVR have expanded, so too have the total number of aortic valve replacements in the U.S., driven by the increase in TAVR procedures. Among Medicare beneficiaries, the number undergoing an aortic valve procedure rose from 56,958 in 2016 to 79,972 in 2020, a 40% increase. At the same time, the number of SAVR procedures dropped by more than half and the proportion of all aortic procedures attributed to SAVR fell from 42% to 15%. TAVR procedures, in contrast, more than doubled from 32,731 to 68,056, accounting for more than 85% of all aortic procedures in 2020.[ii]
TAVR exceeds SAVR procedures in all age groups
The number of TAVR procedures exceeded the number of surgical aortic valve replacements (SAVR) starting in 2019.[iii] Multiple studies demonstrated significant increases in TAVR procedures across all age groups, with a national study showing that TAVR utilization nearly doubled between 2016 and 2021, increasing from 44.9% to 88%.[iv]
A regional study of cardiovascular programs in New England, for instance, found that among patients over age 80 undergoing isolated aortic valve replacement for aortic stenosis, TAVR increased from 86.1% in 2016 to 97.8% in 2022, while TAVR utilization nearly doubled during the same period for those aged 65 to 80 years, rising from 42.1% to 80.6%. Most notably, over the six years of the study, the proportion of patients younger than age 65 who underwent TAVR increased 270%, jumping from 19% to 51.7%.[v]
Despite the dramatic increase in the number of individuals treated for severe symptomatic aortic stenosis by aortic valve replacement, data suggest that severe AS remains undertreated, even at major cardiac centers. A study of 24 U.S. hospitals found that among 12,129 individuals with documented severe AS, 40% remained untreated four years after diagnosis.[vi] Another review of records of 6,150 patients with an indication or potential indication for aortic valve replacement at two major academic medical centers in New England determined that just 48% received AVR.[vii]
In addition, a study in the Journal of the American Heart Association of 2,429 patients with severe AS found that women were more likely to have symptoms and less likely to have aortic valve replacement. Women also had lower five-year survival than men after matching for age, despite generally having longer life expectancy.[viii]
