Was this data what you expected?

No, it really wasn’t. If we think back to just a few years ago, people were still very worried that TAVR may not be as durable as SAVR. That’s what we all thought at the time. There were many concerns that TAVR valves would fail more quickly than SAVR valves. But what this study—the largest study of its kind to date—suggests is actually the exact opposite of that: TAVR valves, particularly the supra-annular, self-expanding valves, have less SVD than surgically implanted valves. TAVR valves are lasting longer in patients of intermediate and high risk. That’s a very important finding.

And it’s not just that we learned SVD is higher with SAVR valves; it’s also the confirmation that deterioration is associated with worse outcomes. The outcomes considered in Pivotal and SURTAVI were all-cause mortality, cardiovascular mortality, and hospitalizations for valve-related disease or heart failure, and patients with SVD saw their risk of those outcomes doubled compared to patients without SVD. So this trial clearly showed that SVD, regardless of which valve it is, increases the risk of mortality or hospitalization. 

This is all really important, and it’s the kind of information that will be referenced all the time when care teams are considering a patient’s options.

What are the key takeaways from this new data from a patient care perspective?

These supra-annular, self-expanding bioprostheses clearly have a hemodynamic advantage over a surgical valve. This matters to patients when you think about the possibility of implanting TAVR valves in younger patients—say, 65 years old instead of 75 or 80—the question is ultimately going to come up about what will need to be done after the valve has failed.

There has already been a lot of discussion about potentially implanting TAVR valves into younger patients, and these findings suggest that could be an effective strategy. This represents just some of the new information that we can give to our patients. Now we actually know what the valve durability is after five years—and in another five years, we’ll know more about durability after 10 years. This is all a big win for patient care; they always like to know as much as possible about the risks and the long-term possibilities before any procedure.

There also are certain patients who just don’t want open heart surgery, no matter what. Doctors were already excited about TAVR, but the new durability data make it easier when patients don’t want SAVR and TAVR becomes our only real treatment option. It gives us more confidence in the procedure—and longevity of the TAVR valve—when we talk about it with these patients.

When you add all of these things together, referring physicians now have much more demographic data to help guide our decisions. With each patient, we can look at their age and all these other factors and consider how many times we may need to intervene on that patient over the course of their life. We need to keep all of these different things in mind, because even though TAVR valves may have this hemodynamic advantage, you have to think about the potential for future interventions. TAVR may now make more sense when treating women, for example, or older patients with no history of PCI or AFib.

Do you have any thoughts about why deterioration may be worse among women?

Even with SAVR, that smaller annulus has always played a key role, so that may be partially responsible. PPM also is more pronounced in women, so that nonstructural deterioration is involved. Considering those things, it did not surprise me that much to see the higher SVD rates with women.

These five-year Pivotal and SURTAVI data seem to have surprised many people in cardiology. Has this shifted your expectations for the 10-year data that we’ll have in another five years?  

You’re right that the medical community found these statistics very surprising. While we wanted the durability to be excellent, we were skeptical but proven wrong by this data. It will be interesting to see where those curves go and what exactly happens in another five years. If the 10-year data look good, we may start to spend more time discussing ways to overcome the challenges that are still associated with TAVR, including the higher likelihood of a permanent pacemaker.

Do you have any unanswered questions related to these findings?

We were talking earlier about the possibility of implanting these valves in younger patients—I do think there is still a lot we need to learn about that side of things. All of these bioprosthetic heart valves, the surgical valves and the transcatheter valves, are going to fail eventually. We always have to remember that and consider how many interventions a patient might end up needing in their lifespan.

What if a patient receives one of these valves and then, years later, they need coronary access or TAVR-in-TAVR? What is the feasibility of these things? Right now, the data do not look that great when it comes to those options. But as heart valve durability improves in the future, that could all change.  

Do you have any considerations for physicians when it comes to the supra-annular TAVR valves? Anything they should watch out for as they refer patients for these life-changing procedures?

While there is hemodynamic benefit with the supra-annular design, and it is associated with lower mean aortic valve gradients, these patients also tend to have an increased need for pacemaker implantation. While the rates have decreased, this risk remains something to keep in mind when considering treating a younger patient.

See important safety information here