What do you see as some of the largest unmet needs around TAVR today?

Vijay Iyer, MD, PhD: I would say long-term data on TAVR durability and its long-term efficacy. We have some 7-, 8-, and 9-year data, but as we start to move into younger and younger patients, obviously, we are now starting to look at 10-, 15-, and 20-year outcomes, which won't be available for a while. Then there are smaller areas of need, such as not being able to treat certain kinds of valves and pure aortic regurgitation. What do we do with heavily calcified valves? How are we dealing with young patients? How do we make sure we don't experience coronary obstruction? There are some niche areas where we need to do better. However, looking at the overall picture, when a patient walks into the clinic, the biggest question they are ask us is, if you do a TAVR today, how long is it going to last? Will I need another valve replacement? And if so, what timeframe are we looking at — is it 5 years, 10 year, 15 years, or do I get longer? I think the best data we have is from the NOTION trial (Nordic Aortic Valve Intervention), which is now 7 years out and has shown that at 7 years, a transcatheter valve is no worse than a than a surgical tissue valve. Data are going to continue to be accumulated. The PARTNER 2 trial patients are going to be followed out to 10 years and longer. So we will have some data, but it is going to take time it to evolve and for us to understand. In the meanwhile, we are making a lot of assumptions based upon what we can do in terms of hemodynamics and advances such as with the Sapien 3 Ultra Resilia valve (Edwards Lifesciences), which treats the tissue in a certain way for it to prevent calcification. Those are the technological advances that we are trying to implement and the goal now is to figure out if it truly translates into meaningful long-term outcomes, which will come in time.

Can you tell us more about the Resilia technology in the Sapien 3 Ultra Resilia valve and what you discussed in your presentation at TVT?

Vijay Iyer, MD, PhD: The Edwards Resilia technology, which is a specially treated tissue that prevents leaflet calcification, already exists on the surgical valve side. We have data out to 5 years showing that surgical valve deterioration with the special Resilia tissue appears to be much smaller. Now all the TAVR valves in the Edwards line are available in the Resilia tissue. There are additional features of the Sapien 3 Ultra Resilia valve, such as a longer skirt to reduce the risk of paravalvular leak (PVL) and also leaflet technology that mimics the Resilia in the surgical valves, so presumably meaning less calcification. With this newer technology, we hope that not only are we preventing PVL in the short term, but also preventing calcification of the valve and enhancing its durability in the long term. The Sapien 3 Ultra Resilia is short frame valve and very similar to the Sapien 3 Ultra, which is a short frame valve that allows for access through the coronaries again. The fact that the Sapien 3 Ultra Resilia has a slightly longer skirt allows you to treat some areas of the annulus that are more heavily calcified without over expanding the valve, minimizing the risk of rupture, but still providing a very good seal. In some ways, the Resilia valve enhances the deployment technique without fundamentally changing the deployment technique.

What has been your experience using this technology?

Vijay Iyer, MD, PhD: Probably for the last year, we have done in excess of 300-plus valves with the Resilia. We have switched completely, as an institution, to the Ultra Resilia technology. We felt that it was worth it for our patients and have moved to this new technology for all of our valves. While it is only a year out at this point, we know that the short-term outcomes are great. There is very little PVL and good gradients, but obviously the real meat in this discussion is what happens 8 or 10 years from now, when we will see if the Sapien 3 Ultra Resilia truly makes a difference for these patients.

Any final thoughts?
Vijay Iyer, MD, PhD: There are a lot of new valves being developed. They are all trying to answer one unmet need or another, but all of our TAVR technologies bring the same fundamental question, which is durability. I think until we have that answer, which will take time, there will still be a lot of question marks relative to this technology. Overall, we have seen that people are voting with their feet. Patients are voting with their feet as well as doctors, so we are seeing TAVR has become the modality of treatment for most patients unless they are extremely young. In addition, with the current generation technology, anything more than trace PVL is a thing of the past in the cath lab. But I think minimizing that rate even further and going to zero PVL should be a goal for the technology development. The challenges are making sure that we can treat all existing anatomies — complex anatomies, heavy calcified valves, coronary ostia that are low, and bicuspid valves — with the existing technologies, achieving the same results we have seen in the clinical trials.

Find more: 
TVT Newsroom (With a Special Focus on TAVR)

• Dr. Iyer presented at TVT during a satellite session on Friday, June 9. View his slides here. 

Read more:
Edwards Launches Sapien 3 Ultra Resilia Valve Following FDA Approval (Sept 2022)