DEBATE Aortic Valve Stenosis: Aspects to consider when treating aortic stenosis in the low risk "young" patient. Toby Rogers, MD, PhD, explains why TAVI is better.
it's an honor to debate. Dr L. Gordon And I thank him for his kind words. So it's my role today to make the case for Tava. These are my disclosures. So I'm going to start with this nice summary. This was a review published earlier this year in the european Heart Journal which lays out some of the things to consider when you have a young patient in front of you who is weighing up surgery and taverna. And clearly there are certain patterns. For example, concomitant valve disease, coronary artery disease, sending aortic valve pathology that will kind of make the decision for you in many cases. But taking those out of the equation for the sake of debate and the truth is many, many patients don't have those things. There is a general trend in the guidelines and recommendations that favor surgery in the younger patients and reserves for the older patients. And much of this as Dr al Gordon's alluded to is based on the issue of durability and the this sort of orthodoxy that surgical valves are more durable. And I just want to start by challenging that if I may here is a systematic review from the Cleveland clinic published just a couple of years ago And you'll see that they analyzed a total of 167 studies of over 100,000 patients and 17 different valve types And across these studies there were 11 different definitions of structural deterioration. Very few of these studies used a call lab to analyze imaging and median follow up ranged from less than one year to 14 years. And if you look at the longest follow up studies, there are a number of patients actually alive at the sort of 10 plus years was negligible. And so I made this point not to say that surgical valves aren't durable, but just to make the point that the data on surgical valve durability is a little sparse. And also it's worth pointing out that in many of these studies, re operation was the only definition of structure of our deterioration. So patients wandering around with high gradients and debilitating symptoms were considered a okay, as far as the studies were concerned, The other thing to bear in mind is that surgical valve technology changes as well. And the valves that surgeons are implanting today are not exactly the same as the ones they were implanting five or 10 years ago. This is some data on the sort of the latest greatest valve that everyone seems to like using the moment, which is the resilient tissue for which. We have five year data in 133 patients published now. Great. The valve looks great. There's no sign of it falling to pieces or deteriorating early. But let's be clear. I think most of us would expect more than five year follow up before we declare a technology durable. And I make this point again, just to compare against the Taber data that we shouldn't just assume and accept that surgical valve by prostheses are more durable than Tava, There is one other larger study looking at this same valve that is enrolling now. But again it's only following patients for five years. So it's not going to give us the data and the answers that we need in terms of long term durability of the valves that are actually being implanted. Today we do have some data comparing tavern and surgery in terms of durability and structure of our deterioration. Many of you will have seen this at the earlier this year and what this showed was that there were significantly lower rates of structural deterioration with Tava compared to surgery at five years. This is Tava using the super annular self expanding core valve family of valves. This is obviously S. V. D. Defined by echo. But it does actually matter because if you look at the patients with structural deterioration compared to the patients without structural deterioration. In this study there was higher all cause mortality, higher cardiovascular mortality and higher rehospitalization in the patients with structure of our deterioration and again I think for the sake of balance. I don't show you this to try and argue that Tava is better than surgery. But certainly all the data we have so far suggest that Tava is just as good as surgery and only time will tell as we follow these patients in the longer. And it is also worth pointing out that the only studies that I'm aware of with systematic yearly echoes of both surgical and Taber valves are the pivotal lowest trials. And so those will give us the best durability data we'll ever have on both surgical and BI and trans catheter by prosthetic valves. But we have at least another five years before we get to see that 10 year data that we all want to see. So if we can assume for the sake of argument that Tavern Sava will last as long as each other, then what we're left with is how to work out, work our way through the lifetime management of younger patients. And I absolutely agree with dr l. Gordon that very young patient. A ross procedure is a great option. But let's be honest, there aren't that many ross procedures being performed out there. I also think that we should be putting in more mechanical valves. But again, let's be honest, most patients don't want to take anti regulation for the rest of their lives and point blank refused to have a mechanical valve. So what we're left with is combinations of surgery. And then surgery. And that's where we run into a bit of a data free zone. Let me show you what we do have here is an attempt using propensity score matching to compare Tavern in Tavern and Tavern Sav. And you'll see in terms of all cause mortality, they seem pretty comparable at least up to one year. If we look at the other end points that patients and we care about again pretty similar between the two strategies. What about surgically X planting trans catheter vows? Well, here's some data from the X. Plant Tavern International registry. And I think at first glance it looks pretty sobering within hospital mortality rates. Almost 12% comparing that with the sts score at the time of X Plantation of 5% or more than double observed to expected mortality rate and one year mortality of almost 30%. But I think it's worth pointing out that in this registry, almost half the patients were having x plantation because of endocarditis. And we all know that surgery for endocarditis is much higher risk. And in fact, only 15% of patients in this registry really had tavern x plantation for structure of our deterioration. That's the patient population that we really want to know more about when we're thinking long term and lifetime management. It's also worth pointing out that in this registry, more than half patients needed. A concomitant procedure such as an ascending aorta replacement might repair or a cabbage, which is most of which are probably related to the fact that it can be technically challenging to remove a trans catheter valve once it's been in for a while. But at the end of the day, we no longer practice medicine in a paternalistic system and patients are very much in the driving seat here is an example of a decision aid. It comes from the american college of cardiology. and it is designed to help patients make the decision to have a versus surgery when they're younger and low risk. You can see here in terms of the benefits. They look pretty similar between the two strategies, at least in the short term, which is where we have the data so far. When you start to compare the risks of the procedure, then I think unsurprisingly the less invasive treatment strategy starts to look very attractive. So what's actually happening in the real world? Well, here is data from the vision clinical database. This is a database of in hospital outcomes, demographics and outcomes from over 1000 hospital facilities in the us. And here's looking at Aortic Valve replacement from 2015 to 2021. And I think as we would expect in the over 80 year olds, Tava is clearly the predominant means a replacement. Over 99% of patients over the age of 18 2021 shows Tava in the age group 65 to 80. You will see a dramatic increase from 2015 to 2021 in the uptake of Tava. And in parallel a dramatic drop in the number of patients choosing surgery. So now almost 90% of patients in this 65 to 80% 80 year age group choosing Tava. But most pertinent to our debate today is the third category. The patients under the age of 65 And here, what you see is in 2015, of patients were having surgery. And that has changed again dramatically over the six years. To a point where in 2021 there is essentially equipoise with half of patients choosing tava and half of them choosing surgery and maybe there's some flattening off at the end there. But it'll be very interesting to follow this data over time to see what actually happens. So I'll wrap up there and again. I thank you for inviting me to debate here and in conclusion the best data on contemporary bio prosthetic valve durability, be it for or Sabah will come from the pivotal Taber trials but we're not going to have that data for five years and I don't believe physicians and patients are going to wait for that before they make a decision decision making must be tailored to the individual in front of you and all of those factors in their very first slide with concomitant disease factor into the decision making as does lifestyle whether the patient is working how quickly they want to recover all of the above. It is worth pointing out that Tava is approved in the US for all surgical risk categories and there is no lower age threshold on the FDA approval. So patients are very much in the driving seat and in my opinion, I think in the end it is inevitable that the less invasive option will win. Thank you very much. Look forward to the discussion.