TAVR in Low-Risk Patients

“In patients who are at low risk for death, stroke or other serious complications of aortic valve surgery, we need to have compelling evidence that TAVR is both safe and effective and also that the results are durable. The consistent benefit of TAVR at three years is not something that has been observed in prior studies and provides further evidence that TAVR deserves to be the dominant treatment modality for patients with aortic stenosis undergoing valve replacement.”

“I believe this data meaningfully contributes to our understanding of TAVR and our understanding of surgery and the treatment of aortic stenosis. I think it helps us in our shared decision-making process. There may be instances where we look at this data and think, 'In this patient, I might do something different now.' Broadly speaking, though, is it going to change my entire practice? No. It's a piece of data that contributes to an ever-emerging field.”

“We've committed to reporting this data frequently and transparently because this is the low-risk population... which we expect to live a longer time than the intermediate- or high-risk populations. Knowing the data frequently, so you don't find out later that something snuck up on you, is important. TAVR is going up [in volume], but our guidelines say that if you are [younger] than 65 and expect to live 20 years or more, you should have surgery. Yet, there are some places in this country where more than 50% of people younger than 65 with isolated aortic stenosis are getting TAVR. It's important for the country to understand that.”