Cardiovascular Rounds

Breaking: FDA approves TAVR in intermediate risk patients

by Marissa Schwartz

TAVR indications have expanded dramatically, thanks to recent FDA approval of two devices in intermediate-risk patients. Read on to see our analysis of this newest TAVR update.

TAVR history: Indications expand

Back in 2011, the FDA approved TAVR for only those aortic stenosis (AS) patients who were deemed “inoperable,” or ineligible for surgical aortic valve replacement (SAVR). Since then, several factors have driven adoption of the procedure, including program expansion, increased operator experience, next-generation devices and delivery systems, increased awareness of aortic stenosis, and indication expansion to high-risk patients in 2012. On the heels of improving outcomes and increasing interest, TAVR trials began in intermediate-risk patients.

Fast forward to April 2016. At ACC 2016, results of intermediate-risk trials showed TAVR’s non-inferiority, and, in some groups, even superiority, to SAVR. Soon after, Medtronic’s CoreValve Evolut R device was granted CE Mark approval in early August, the first time a TAVR device was approved for this population. And now the FDA has approved two Edwards Lifesciences’ devices, Sapien XT and the Sapien 3, for intermediate-risk patients (those with at least a 3% STS predicted risk of nortality).

Of note, two low-risk trials also began in early 2016, suggesting that there may be further indication expansion to come.

Volume increases expected to continue

TAVR volumes have grown dramatically since the technology’s inception. In 2015, that trend held steady at about 50% year-over-year growth. But indication expansion to intermediate-risk patients is poised to drastically grow the market size. In one study, in the years prior to TAVR, 14% or more of SAVR patients were considered intermediate-risk. Note that estimates vary due to differing definitions of risk categories, but the takeaway is clear: there are many patients who may now be new candidates for TAVR.

High-quality, high-value care an increasing mandate

With increasing volumes, programs must focus on efficiency improvements to accommodate more patients. At the same time, improving outcomes is a critical goal, especially as we move into lower-risk patient populations. So while expansion to intermediate-risk patients is exciting for programs, it also challenges us to improve quality, improve efficiency, and ensure a high-value program.

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