Research
FORUM TRANSCRIPT

TAVR – Competitive Landscape & Treatment Paradigm – 11 November 2021

  • Public Equity
  • Healthcare
  • North America
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Specialist

Cardiologist at Heart House NJ

Agenda

  • Customer assessment of Edwards Lifesciences' (NYSE: EW) vs Medtronic's (NYSE: MDT) vs Boston Scientific's (NYSE: BSX) TAVR (transcatheter aortic valve replacement) offerings vs surgical valve by patient risk and age
  • patient risk and age 2. Clinical advantages of Abbott's (NYSE: ABT) Portico minimally invasive FlexNav delivery system and potential pricing’s impact on uptake
  • Abbott's recent European launch of its newer-generation Navitor TAVR implant and FDA approval outlook
  • Pacemaker rate concerns around the Navitor

Questions

Transcript

1.
Could you outline the patient population for TAVR [transcatheter aortic valve replacement], including how we should segment it and what the standard of care is?

Specialist (SP): Especially for the US, it’s changed a lot. We had a very strict, high-risk criteria in the beginning and then obviously moved to intermediate-risk and now low-risk and, not just for our system, but I know all the systems in the area, we all get around together and talk and patients are smart consumers. They know and they see and they read the ads and they know they have a choice now of what they want, so the patient population has changed tremendously.

I work in an under-served area, so I see a lot of under-served Medicaid, a governmentfunded insurance programme, which is not the main population in all of the US but definitely for where I am, that we see a lot of under-insured patients which, again, under-represented in all the trials, for sure.

Then we’re seeing a lot more women that we never really saw before too but I think the younger patients where we had traditionally offered surgery upfront really are not wanting open surgery, want a more minimally invasive approach and they’re coming in and asking for a transcatheter valve replacement. That’s really changed the patient population significantly.

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2.
What’s the treatment paradigm for TAVR? At what stage is it or open surgery considered as options and in what line of therapy?

SP: I’m still offering the younger patients, the 60-year-old patients, especially ones that we think are bicuspid aortic valve or have an aortopathy or something along those lines, who are at low risk, less than 1% SCS scores, surgery is a primary option. I think a lot of us are still doing that, although some patients are refusing that and the reason being is that from a re-operative perspective, the likelihood of needing a second surgery at that age in this particular day and age is high.

We’re definitely seeing some of the early transcatheter valves come back for re-interventions and in a 60-year-old, where a surgical valve may last an average of 15 years, 75 isn’t really that old anymore, so having to do a re-op or even a TAV-in-TAV at that age is probably not the best option. Doing surgical valve upfront when they can tolerate it and then doing transcatheter valve when they’re in their later seventies has definitely come out as being a primary modality for some of these younger, low-risk patients.

Third Bridge (TB): To clarify, perhaps surgical valve is more appropriate for 60-year-olds or patients aged 75 and younger at lower risk.

SP:At lower risk, yes.

TB: So for the medium and higher-risk, you’d go with the TAVR even if they were in the younger age bracket?

SP: Yes, I’ve had a few, even 50-year-old bicuspids where they’re just too sick to have open surgery, end-stage renal disease on dialysis, bad peripheral vascular disease and their ability to tolerate even the rehab post-op would be extremely difficult, or the extremely morbid obese where open chest wounds are going to be very high. Those ones, after hashing out with the surgeons and looking at their overall risk, their risk from open surgery would be a lot higher and their ability to have transcatheter valve in transcatheter valve down the line is still not negated. We’re doing it already, so at least they do have an option later, it may not just be the best option

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3.
What percentage of patients typically get TAVR vs surgical valve?

SP: Over 75, like you said, they’re pretty much all getting TAVR. None of them want open surgery, and unless there’s some other real reason, they’ve got multi-vessel coronary disease, not amenable to stenting or some other very big outlier, very large ascending aorta or annulus not appropriate or vasculature not ability, they’re pretty much all getting transcatheter valve.

From the younger population, it’s probably, I hate to say it, it’s like a 50/50 split because there are enough of the younger patients, especially that mid-60 range, who are right in that, “Surgery is probably better off for you, but you’re getting older and you don’t want to have the potential for the morbidity of surgery,” so the patients are asking for it.

Now that it’s low-risk, it’s not like I can’t offer it to them, they have the ultimate right for themselves, so it’s probably about 50/50 in that population. In the very young cases like the 55-year-olds where they’re clearly a bicuspid case, we’re pretty much doing surgery on all of those, unless there are some other outlying factors, maybe 5% where they’re otherwise ill, end-stage renal disease, something very high-risk, prior chest radiation or something along those lines.

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4.
You said TAVR was historically only approved in the higher-risk patient category, but there’s now been the expansion for intermediate and lower-risk patients. How has this encouraged uptake and how does the broader set of indications encourage adoption among physicians?

SP: It definitely has, and the data really shows almost all of the trials, at least non-inferiority to surgery, so why wouldn’t the patients want a less invasive approach over a more invasive approach? It just makes sense. It’s definitely changed a lot where those lower-risk patients were all getting surgery five years ago and then now they have a choice. Even if I tell them I think that they’re better off with a surgical valve, especially if it’s a good-sized valve, they could put in a 29 valve, surgically they’re going to have a great outcome and maybe not need another intervention later down the line, or if they do they’ll easily get a transcatheter belt.

Patients are wanting it and the advertising here in the US has really pushed direct-to-patient, direct-to-consumer advertising on some of these things, has really been pretty compelling to the patients and it’s worked well for the different companies. They come in, they’re asking for it, they’ve read about it and they want that noninvasive approach.

Ultimately I think one of the bad parts of all of this is that we still need competent surgeons for the cases that need surgery, so if each institution is only doing 50 surgeries, is that really enough? That’s like the minimum amount allowed is, I think, 25 in order to keep your designation as a transcatheter valve centre. For a really competent surgeon 25 valves is pretty low, so that’s, I think, a big negative of having patients being able to choose for themselves every therapy and decide what their care is going to look like.

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5.
Could you elaborate on the surgical valves’ benefits over TAVR?

SP:One is definitely leak, although right now the major companies are coming up with skirts and sealing paradigms and the potential for a leak has been extremely low now, which is obviously a huge improvement from their early days, so that’s going away, so that’s a good thing. Sizing wise, I think that the transcatheter valve wins a little bit. The profile is definitely slimmer and you can get a bigger valve in a smaller hole.

Some of the surgical valves that are using stemless technology definitely improved with some of the bigger valve types instead of a sewing ring. I think the transcatheter route as a whole does better on that front. I think longevity of the valve is still unclear. There are definitely early failure rates, we have this sub-clinical leaflet thrombosis, there are definitely a lot of questions in that regard, whereas surgical valves have years and years and years of data, especially the larger-size valves are extremely good and can last a long time. Then just need for reinterventions in a young patient, obviously, the transcatheter valve, if they’re only lasting five or 10 years, you’re going to be doing a lot of transcatheter valves.

The valves themselves are expensive. They cost an enormous amount. The companies have not budged on pricing and the surgical implanted valves are cheap, so from a hospital perspective it’s a huge upfront cost, although there are a lot of savings in the back and I’m sure we’ll get to that. The hospitals, at least in the US, some of them are non-profit or some of them are privately funded and they really make a lot of decisions based on cost of devices as well.

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6.
You use Edwards’ Sapien 3 and Medtronic’s Evolut TAVR offerings. How does your usage of each differ and how regularly do you use the two offerings?

SP: I’m about 70/30 Edwards to Medtronic. Edwards is a great valve. It was the first valve, first to market usually does pretty well, obviously, we’re using Sapien 3, we’re using the Ultra. Delivery sheath, very good, difficult anatomies, definitely is easy to place, the ease of deployment is typically good, it seals very well. There are really not a huge amount of drawbacks other than the intra-annular design, so for the smaller valves, and I know a lot of the data has come out recently about higher gradients, especially with the 23 or the 20, I can honestly say I’ve never used a 20. I think that that’s ridiculous,

I would never put a 20 millimetre valve in someone when I have an option for a larger, better haemodynamic valve in the Medtronic valve. A lot of the data that’s come out recently, the smaller valves have, at about a year, higher gradients which can translate into earlier failure as well as patient prosthetic mismatch. The Medtronic valve is really starting to push a lot of that data and it’s come up with a nice tool for themselves marketing-wise to get people to use their valve, especially in the smaller annulus, and by smaller annulus I mean 23 or less.

A lot of the time, the 23 millimetre Edwards Sapien valve translates into a 26 millimetre Evolut R and even probably I’m finding about 15-20% of the time it translates into a 29 millimetre Evolut R. It just has to do with the way that the measurements are for the different valves. One uses area, one uses perimeter in the way they were designed, so when they’re on the cusp, a little bit of a larger 23 can actually fit a 29 and the haemodynamic profile is going to be far superior in that case with the Medtronic valve.

The Medtronic valve has really started to come to the forefront, especially when it comes to smaller annulus for especially, let’s say, a larger patient with a smaller annulus and you’re looking to get the best haemodynamic profile. That’s how we’ve approached it at our hospital, that particular patient population really benefit.

The other one is the left ventricular outflow tract calcium. When you use a balloon-expandable valve, a risk of annular rupture with heavy calcium at the annulus or LVOT can be devastating and the selfexpandable valves don’t require that, so that’s really the other big population that we’ve used it in is the heavy calcium at the LVOT or the annulus. That translates only into about 20-30%, so some people are more aggressive, some people are less aggressive. I’m in the 30% range.

If I see a smaller annulus and I can get a Medtronic valve in there I’ll likely do that. I’ve had a little bit of difficulty both ways with the bicuspid aortic valves, although both companies tout that they’re good in bicuspid valves, although it may or may not be fully approved, obviously we’re all using this stuff. I’ve had difficulties both ways, so I think my biggest difficulty with the Medtronic valve has been… One of the good things about the Medtronic valve is that contouring of the valve itself but the strength of the valve really isn’t enough to open the valve all the way. I’ve had a few where the calcified raphe has stayed intact and then, in that case, I have a little bit of a restricted valve opening and I’ve gone against what I wanted which was the bigger orifice area of the valve and then, unfortunately, if you try to balloon that it may or may not do anything and you have risk of embolisation of the valve.

Then from an Edwards valve, it’s a circle and a bicuspid valve is an oval, so I’ve had some leak problems with the Edwards valve. The bicuspid valve, unless they’re high risk for surgery, I’ve still been really pushing them for surgery because I just haven’t had optimal results with the current US technology. I know that there are certain other techniques in other countries and whatnot that they’re using to cut leaflets, Basilica technique and all these other things but we’re not doing that routinely. Anyway, I went on a tangent. My current algorithm for which valve I’m going to use, Edwards is going to be my primary valve. It’s just ease of use as well as excellent outcomes and long-term data and then Medtronic for my smaller valves, LVOT calcium and that.

There’s a lot of negative data on the Medtronic valve from coronary re-access perspective. I, personally, don’t find that problem often. There are enough techniques that I can get to the coronaries pretty safely but obviously, it’s a big thing in many of the different centres nationally here. There are a number of techniques that have been developed in order to combat that problem. Implantation technique, overlap techniques, actually the pacemaker techniques, the high implantation overlap technique for pacemakers, to reduce pacemaker rates have been really good and have reduced pacemaker rates. I feel like the more we use some of this stuff the more techniques will come out that have better results

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7.
You said your usage splits 70/30 Edwards to Medtronic. How might this split trend longer term? Do you think it will be fairly stable?

SP: I think it’s going to be pretty stable. It’s been like that for a while. We’ve had some increases and decreases, just based on the population that we get but, on average, most of the operators in this area follow that same algorithm.

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8.
The FDA recently approved Abbott’s Portico with its FlexNav TAVR system. What are your thoughts on this device and how disruptive might it be to your usage?

SP: Definitely been a long time waiting. I feel like the original stuff was two years, so excited, however I think that it’s going to be a slow roll-out, partly because right now it’s high-risk only and we’re seeing more and more and more of these intermediate and low-risk. The profile is very attractive from a vascular perspective.

When we first started doing the transcatheter valves, the sheaths were so big and we were having a lot of vascular issues, bleeding and multiple Perclose devices to close, vascular injury that when the sheath deliveries got smaller with the other companies, we really had a huge drop in vascular complications, so this is just another size smaller, which is awesome, so from trackability really is a plus. One downfall I guess would be, although it’s self-expanding, it’s intra-annular again, so I’m curious on how the haemodynamic profile will work with the different sized valves and I think that’s something that we’re going to learn over time a little bit. We didn’t really see that data out of Medtronic for a number of years even, so the same type of thing to see how it relates to haemodynamics, is this going to replace the self-expanding Medtronic valve with a supraannular design? Maybe not.

Coronary re-access is a non-issue because the aortic cells are so large that that’s really not going to be a problem, which is nice. Pacemaker rates are high, but they’re not egregiously high. I think the ID trial was 15% range, whereas the Medtronic original trial was way higher than that, although our pacemaker rates overall, even with Medtronic, are well lower than the original trials. Our current hospital is doing under 10% pacemaker rate for a combination of both valves easily. Pacemaker rate, I think, which will probably drop with more use and better implant techniques, similar to how that occurred with Medtronic, so I think we’ll see the pacemaker rates decrease over time with just more use and better implant.

It’s exciting to have another option, although I think it’s going to be a slower roll-out. Third to market, I guess we all saw what happened with the Lotus valve, third to market, it had some mechanical issues as well, high pacemaker rates, not a great adoption of the technology and now that’s gone. I have these other two options I’ve been using, I’ve been doing well with them, what is this particular valve offering me that’s above and beyond these other valves? It’s a slightly smaller delivery sheath, that in itself will only account for 5-10% of the patient population that I’m serving, so that’s the only benefit to this valve.

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9.
You mentioned the Portico will only serve around 5-10% of your patient population. How might your usage split trend across Edwards, Medtronic and Abbott? Where could Abbott take share from Edwards or Medtronic with the patients you treat?

SP: It makes sense. I think it will probably be split, so some of the smaller anatomies that we’re looking for better sheath delivery, because right now, at least from the data, it’s non-inferior to the other currently available valves and only in a high-risk population. Until it becomes a low-risk population, you’re going to see a very low usage of this valve. They haven’t shown anything or there hasn’t been any data shown or even any hypotheses of how this is really going to be better than our other commercially available technologies.

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10.
You mentioned Boston Scientific, which had Lotus and eventually had to pull that option. Could the company’s arguable failure make people slightly more sceptical for Abbott’s launch, considering it’s a new option on the market when there’s already the tried-and-tested Edwards and Medtronic options you’re used to using?

SP: I think that it may not make them sceptical. Boston had some delivery sheath issues is really the main reason they decided to pull it off the market, so here, I don’t think that there are a lot of those same issues. It sounds like the sheath is really where the benefit is for this particular device but I still think that when you have certain devices that are already in use and you have a third device with a limited patient population that we’re using these devices in, then it’s going to be a much slower increase.

The FDA approved Portico here in the US in September, and we still don’t have it at our hospital, partly because I think some of the operators were like, “We’re not going to buy a whole bunch of these valves that are going to sit on the shelf if we’re not going to use them.”

A lot of the hospitals in the US aren’t major trial centres. There are a number of hospitals that will do transcatheter valves that don’t have educational programmes. Having three vendors for one product is not what they’re going to want. I don’t think that the Boston experience is going to sway people. I think it’s just that same issue of having a third to market in a limited population without a clear-cut benefit is going to be tough for people to want to switch over.

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11.
You mentioned pricing as perhaps a sticking point around the TAVR offerings’ uptake vs surgical valves. If Abbott came in with a lower price than Edwards or Medtronic, could that lead to a bigger shift in uptake despite the smaller indication?

SP: I would say, unfortunately, yes, I think that would. I, actually, at one point sat on the finance committee for my hospital as well. I was doing way too much for the hospital, but I was sitting on the finance committee and there were only two things that the products and finance committee really wanted to know, what was the clinical benefit and what were the cost savings? Other than that, on to the next product.

That’s the way that a lot of these places work, so yes, if there’s a cost saving it’s going to be very attractive to the hospital which may or may not translate into attractive to the physicians but in a lot of the US, the physicians in the hospital are aligned heavily on a lot of these potential savings protocols.

The hospitals are owning more and more physicians, so the physicians are taken out of the equation in a lot of these places. I think cost would change things somewhat, although I think you’d still have difficulty, especially until at least intermediate-risk patients were being able to be done because I think that if you look at all of the patients, high, intermediate and low, intermediate is probably our number one population.

I think we’ve changed the high-risk, we’ve lowered the bar a little bit and some of those inoperable patients, the 100-year-olds and things like that, we’re not even really offering them anything anymore. We’re just saying, “You’re out of the picture, you’re group D cohort, medical therapy only which we know doesn’t work.” From a cost perspective, I think that you would be able to get some more market share.

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12.
You mentioned pacemaker implantation, which was required for 15% of Abbott’s study participants. There was even higher pacemaker levels in Medtronic’s clinical trials and then that’s lowered significantly. How much of a drawback is the 15% figure in the studies for Abbott’s devices compared to Edwards and Medtronic’s? How might the pacemaker level decrease over usage?

SP: Definitely, the pacemaker rate I guarantee will decrease over usage. We saw that with both of the other valves. The original Edwards valves had over 10% pacemaker rate and we’re seeing about a 5% pacemaker rate now and it’s just a higher implant technique, understanding the valve mechanics when they’re in the body and implantation really has changed how things are.

Then understanding a lot of the mechanism of the pacemaker needs, being further into the LVOT or even moving back and forth in the LVOT, damaging the electrical system, has definitely brought us further on. We even saw that with the Lotus valve, when they originally were implanting they were 30% and partly it was because they were starting at the annulus and the way that their valve worked was that it was mechanically deployed from the bottom up, so it was coming up and scraping against the LVOT. They changed it to go the other way, so the top piece came down and it sat more in the annulus and they dropped their pacemaker rates significantly. I think with continued use of any of these products you’re going to get to some kind of bottom floor numbers, so I don’t think 15%, especially in an original trial, the approval trial, I think that that’s very reasonable, it’s in between the two valves and I definitely see it coming down.

Obviously, none of us want pacemakers and there are definitely higher-risk populations that we’ve been able to identify and that’s actually one of the ways that our institution has been able to mitigate some of that is that patients that are at very high-risk for a pacemaker, we’ll actually do a monitor on them to look to see, “Hey, were they going to need a pacemaker anyway? Are they having intermittent heart block at home unbeknown to them, or other potential indicators for a pacemaker?”

We’ve had a number of those cases come back requiring a pacemaker even before they needed the valve, before they ended up with their valve replacement, so I think a lot of these patients have multiple risks, especially in a higher-risk population and sometimes you can identify the need for a pacemaker even beforehand. Ultimately, yes, I think the pacemaker rate will come down. It’s not a huge deterrent but it will take some time.

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13.
It seems we don’t necessarily have much long-term data for TAVRs, so there are some unknowns. What are the potential long-term risks associated with TAVR data? What should we be mindful of and how much of a concern are these to you?

SP: I think one of the biggest things is, if I put a valve in and let’s say the patient ends up with endocarditis of the valve, removal of these devices is not easy. Actually, at TCT they just had a case they showed of them removing a Medtronic core valve from a patient due to endocarditis and the valves end up becoming part of the patient, just like any other implanted device. They endothelialise and you can’t just pull it out, you’re going to tear the entire aorta, so it’s a very careful dissection of the valve around and trying to get it out of the annulus without causing a rupture, extremely complicated, so trying to prevent some of the long-term problems, I think, is really important.

I think the use of antibiotics to prevent endocarditis for these patients for certain procedures is an excellent idea and we’ve been doing that, so we haven’t seen a ton of endocarditis thankfully with these devices because of that. Removal of this is extremely delicate and difficult, so if the valve fails, turn round and say, “We’ve got to take it out to put in a surgical valve,” I think those patients are pretty much going to get TAVR-in-TAVR because it’s just too hard to get it out. If they had any kind of risk in the beginning, they would be definitely a high risk for a removal procedure. Other long-term concerns, obviously it’s just early failure, migration of the self-expanding valves, which I really haven’t seen.

There have been a couple of case reports, but they have been few and far between in our location. Long-term pacemaker really hasn’t been a huge deal, although it’s been a lot of talk. Most of the pacemaker rates we’re seeing, it’s really in the first 30 days. At a year maybe there’s a small increase, maybe the patient was going to need it anyway, so I don’t think that there’s enough data to say that the long-term pacemaker rates are that much higher than the original implant time.

There was a trial that was shown, TAVR vs surgery, and that the pacemaker rates were significantly higher than the surgical pacemaker rates on a longer-term basis but I also think that a lot of that number was the upfront pacemaker implantation, not necessarily the five years out requiring a pacemaker because of a transcatheter valve. I think that’s a very far stretch, so I don’t think that that’s really an issue.

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14.
How often do removal procedures happen?

SP: Thank God I’m seeing them zero because these few case reports that are coming out with having to actually remove these valves, it’s a little frightening, so thankfully I haven’t been seeing that.

I think, in the early days, I remember the first generation Medtronic CoreValve, when it was not a re-positionable valve, if the valve popped out and then trying to snare the valve and pull it into the aorta, it was a scary thought but did happen. Once it became a re-sheathable valve that became zero, so that was a nice feature, repositioning of the valve is very nice, but ultimately I still haven’t had to see anybody go back in and remove these valves at this point, at least in my institution, really just in some of the greater conferences that I’ve attended.

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15.
Some medical literature suggests the lifespan of the tissue valves used in surgical aortic valve replacement is typically about 10-20 years. TAVR valves are made of the same biological tissue. Could we expect their longevity to be similar? What’s your outlook?

SP: I think we’re seeing TAVR valves last a decent amount. We’re not really at the 10-year commercially implanted valve spot yet, for the US at least. Obviously, in Europe, it’s much longer but we haven’t seen the data necessarily come out either, it’s really just been the five-year data.

I think the earlier valves, it’s really hard for a lot of us physicians to say when you come out with this five-year data, you’re looking at Sapien 1, 2, we’re already on third-gen valve, fourth-gen valve, different delivery systems, so trying to compare it’s so difficult. I just saw a five-year follow-up from one of the first Sapien 3s I put in and the valve still looks great.

I think that there are certain factors that are going to make the valve longevity to be equivalent and then certain factors that will be an issue but would probably be an issue for a surgical valve as well. I always have the patient population of end-stage renal disease on dialysis, nothing lasts for these patients. Whatever it is, whatever dialysis is doing to them or the kidney disease, surgical valves don’t last in those patients, transcatheter valves are likely not going to last in those patients either. If we can weed out some of those higher-risk populations and focus more on appropriate-sized valves in an intermediate to low-risk population, then I think that from that standpoint it will likely hash out equivalent.

Again, especially with a correct-sized valve, so when I say that, it’s that the smaller annulus, if I’m going to put a smaller Edwards valve in instead of a larger Medtronic valve, you may see more early valve failure in those cases and then same thing when you’re trying to over-size an Edwards valve is when you have more of the leaflet thrombosis, which can cause early valve failure as well. I think the difficult part will be that the early experience with transcatheter valve, the first number of years where we’ve gotten better at putting the valves in, choosing the valves, understanding the mechanics and haemodynamics, if you can take those out of the picture then I think, moving forward, we will have equivalent outcomes from a surgical perspective, especially in the straightforward cases.

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16.
We recently had three Medtronic events and five-year data from the company’s SURTAVI trial with intermediate surgical risk for treatment and that was mostly with its CoreValve device. The rate of all-cause modality or disabling strokes in the TAVR group was 31.3% compared to the surgery cohort’s 30.8%. How should we interpret this data? How positive is it for potentially encouraging TAVR uptake among physicians?

SP: The rate seems high but you’re looking at five years in an earlier trial where there are probably more highrisk patients as well and really the outcomes were not that dissimilar, so that’s very encouraging data for early Medtronic users and, I think, just for the industry as a whole. I

think it should be interpreted a little with caution but, at the same time, I think it’s very promising that things are about the same, being that this population is typically older which means that longevity is going to be less, that I feel like a lot of these trials are going to see that higher total composite endpoint to be higher because you’re dealing with an older population.

Older patients are going to have more strokes, they’re going to have more heart attacks, they’re going to have deaths more often than a young population, it’s just the way it goes which can account for why the rates are so high.

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17.
The trial data between the surgical and TAVR cohorts doesn’t differ that much. This is an older trial, as you mentioned, so as more of the five-year data comes out and the cohort results are quite similar, could this encourage higher TAVR uptake?

SP: I think it will and then you’re going to end up seeing registry analyses and real-world data come out and then you’re really going to see. I think the real-world data, a lot of these randomised trials, you’re really cherry-picking every little thing and it’s just not real life. Real-world data, I think when that comes out, will hopefully corroborate a lot of this and show that it’s equivalent to if not better than, especially from a perspective of recovery and shorter hospital stays.

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18.
There’s also the Navitor, a new iteration of the Portico, which boasts a new sealing cuff meant to reduce PVL [paravalvular prosthetic leak]. How much of an issue has PVL been in the Sapien 3 and Evolut and how Private and confidential 12 much of a concern is it to you as a physician? How promising does the Navitor seem around helping reduce PVL with the new sealing cuff?

SP: I think it’s very important and I think the reason being is that when you look at early Sapien to Sapien 3, the rates of PVL now are minuscule. I don’t see any moderate PVL or more with either device at this point, especially because of their sealing skirts. The early data showed moderate or worse PVL had worse outcomes, so PVL is a big problem if it’s there. Thankfully, we’re really not seeing it that much with Sapien 3 and even Evolut Pro with its sealing skirt, so a sealing skirt is very important for all of the docs. I think everybody agrees that there’s really no reason to have PVL anymore, especially with these sealing skirts. I think Navitor, I think that had to be, although reading a little bit more about just Portico in general, I guess it had some skirt, but this is clearly an advancement on the PVL side for Navitor, which any competitive valve now has to have a low PVL rate and especially when it comes to moderate to severe.

TB: To clarify, this won’t necessarily be a huge competitive advantage for Portico because you’re not noticing large cases of PVL in the Sapien 3 or Evolut?

SP: Correct and that’s why I was saying in the beginning, it’s hard to be third to market. You have to show something that you’re going to be better at than the other valves and there’s really not a ton I’ve seen so far, other than it’s the smallest delivery device. That’s really the only competitive edge I see unless I’ve missed something, but I don’t know if I have.

TB: If it were to be competitive on price, that would be a potential competitive advantage?

SP: Correct. Price, always a potential but, clinically, PVL with these other devices is very low and pacemaker rates have come down and they’re working on coronary access problems with the Medtronic one, they haven’t really had that with the Sapien one. That’s where I was going with that.

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19.
Edwards recently reported economic implications of choosing TAVR vs surgery in particularly low-risk patients. TAVR devices are far more expensive than surgical, as you highlighted. How does the pricing compare between TAVR and surgical, breaking down the cost? How important is pricing in decision-making?

SP: From a valve in general, and this isn’t specific to my hospital and it’s not any proprietary information, this is nationally known, both current transcatheter valves are priced in the USD 32,500 range. There are some rebates that exist and things like that but, if I was going to buy one valve, that’s the price type of thing. That’s a lot more than the current surgical implanted valves which range anywhere from USD 5,000 to USD 10,000, so these valves are significantly more expensive. Where a lot of the hospitals’ operating margins are very slim, it’s a hard nut for the hospital administrators to swallow to spend USD 32,000 on one valve instead of doing surgery. The reimbursement from the insurance companies is not any different. It’s really minimally different.

When the reimbursement, let’s say, for a transcatheter valve replacement may be USD 40,000 and you’ve already spent USD 32,500 on the valve and then you’ve got to pay the staff and all the other equipment and the OR time and the overnight stay, there’s not a huge margin there. Whereas the monetary reimbursement from a surgical procedure is also in the USD 40,000-50,000 range and I’ve only spent USD 5,000 on the valve.

The biggest thing when you’re doing the comparisons, and these companies have put together very smart financiers that have put together a lot of great presentations, is that what’s the cost of a five- to sevenday hospital stay and then the need for a rehab of some kind, whether it’s an in-patient rehab or a sub-acute rehab or even a home rehab, when you add in all the costs for all of those particular things, length of stay, rehab needs, etc, then you’re up to the USD 32,000 range anyway. The benefit from the transcatheter is that you’re spending a lot on the valve upfront but you’re discharged in one day and there’s no need for post-operative care at home or in rehab in the majority of the cases at this point, especially at our institution we’ve been doing conscious sedation using propofol, a monitored anaesthesia protocol, early ambulation and next-day discharge. That’s where a lot of the finance people have been able to understand the financial benefit, at least if it’s not hurting the system, if it’s an equal finance overall, then it’s probably worth it. It’s harder for the hospitals because the hospitals don’t necessarily own the rehabs. They’re going to some other rehabs, so the hospitals are not necessarily seeing that cost-saving, it’s really the system as a whole.

If we were a global insurance, like Medicare or if we had government-run insurance then it would be the savings as a whole or the cost as a whole would be at least equivalent. It’s still tough because in the US there are a lot of moving parts to healthcare and especially when it comes to insurances.

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20.
In its recently reported economic implications, Edwards also highlighted over two years of TAVR follow-up costs was around USD 2,000. Does that sound accurate to you? What might be involved in these follow-up costs compared to open surgery?

SP:I don’t think that the open surgery cost is too much either. There are a certain number of echocardiograms that need to be done, you’re having a 30-day echo and a one-year echo and a two-year echo and maybe some antibiotic needs for endocarditis prophylaxis, just clinical follow-up with the cardiologist. I think a valve that’s not having a problem doesn’t have a huge follow-up cost need but surgery, same thing, they don’t really have a huge follow-up cost on it either.

You need a 30-day echo, probably a surgical visit, clinical cardiology follow-up and a one-year echo. I don’t know, and maybe you do, that if they were comparing the surgical cost, I would say TAVR or surgical cost after 30 days was probably equivalent, whereas in the first 30 days for surgical, obviously, it’s going to be more because there’s going to be some type of rehab need. I don’t think I’ve ever seen someone go for an open sternotomy approach without needing any type of rehab, I don’t think I’ve ever seen that.

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21.
The cost of TAVR procedures could decline as increased competition enters the market. How would a price decline impact your adoption of TAVR vs surgical valves? What could a split be if the price were to decrease?

SP: I think that because the Sapien valve is just so heavily used, I think that that will probably stay as the number one valve and then it will be a little bit of a battle between the Medtronic device and the Abbott device and from cost, you always want a second valve option, if the cost is significantly improved. I know Medtronic, in the past, had been very aggressive with some of their cost savings initiatives, not necessarily reducing the price of the valve, but doing more bundled savings and Edwards has not been as aggressive at all. I think that you’d have to come in pretty far under the price in order to make it really attractive for some of the institutions. For physicians, there’s always that split between, “What do I want to use? What does the hospital have?

If I’m a hospital employee and there’s some kind of monitoring programme, am I the highest cost operator? Are they going to fire me because of that?” type of thing vs, “Am I a private practitioner and the hospital is my playground?” There are a lot of those small factors but I think that the pricing would have to be very attractive in order to really push that benchmark, especially when these companies are pretty savvy with their cost-savings initiatives. I’m sure Abbott is also, I know they had it with St Jude and they could probably do cross-platform savings between their EPS division and the valve division, coronary division, so I definitely see that in the future.

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22.
You said Medtronic have been quite aggressive with cost-saving initiatives and Edwards has perhaps not been as aggressive, and that seems to be the number one valve among physicians. Might there be more of a cost-savings initiative from Medtronic and Abbott in the short term as they try to compete for the number two spot? Will Edwards remain fairly stagnant, at least in the short-to-medium term?

SP: I think so and I think, for the US population, I think as every year Medicare changes their reimbursement rates on different things, so I’d say when transcatheter valve reimbursement goes down, because in the US reimbursement goes down for everything at some point, so when the reimbursement goes down, then it’s going to be really attractive to have a lower price and that may even squeeze Edwards to have to reduce their price as well. At some point, that’s going to occur, just as far as the timing is unclear.

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23.
Bicuspid patients are a key patient population not currently included with TAVR. They’ve been excluded from landmark TAVR trials historically, but observational studies suggest bicuspid patients could share the same early benefits as other TAVR recipients. What are your thoughts on this? What would you need from a trial here?

SP: That’s a good question. The bicuspid patients, the ones that we’re more willing to do for bicuspid population is going to be the higher-risk patients because, likely, the risk of long-term negative effects is going to be equivalent to the risk of surgery in those particular cases. I think you’d have to see. You’d probably have to start with a high-risk cohort.

Obviously, like you said, we already have observational studies, there’s already some amount of bicuspids in some of these trials and you’d have to start in the same methodology that they’ve had to start with the high-risk and move to the lower-risk. You’d have to see really good outcomes in the lower-risk by bicuspid and I just don’t know if you’re going to see that. In my personal experience, bicuspids have some amount of leak. There’s been under-expansion of valves.

I’ve definitely seen my share of issues with the bicuspid population and then from a case of aortopathy, and we discussed how difficult it is to get these valves out, if the patients have enlarging aortas after we put these valves in, what’s the next step? Are they then going to have surgery and have the valve removed? I think doing a trial for these particular patients, it’s going to very selective and probably difficult to enrol and difficult to hash out. You’re going to have a much lower number of patients, you’re not going to be in the thousands range, for sure. It would definitely be a tough trial but you’d have to see very good outcomes, especially in the lower-risk population, if that ever occurs.

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24.
How much of a need is there for TAVR approval within the bicuspid population? Could there be significant demand for it if there are good trial outcomes?

SP: I don’t know if there’s necessarily a need but there’s a want. A push for all of this stuff is to have less invasive technologies to treat these disease states, so I think everybody wants it. Whether or not it’s truly needed in a lower subset is questionable because we already have all these other things, especially surgery with aortopathy and things like that, one surgery to correct it all.

Ultimately there’s a want and then in the high-risk population there’s a definite want and we’re already doing it, so I think the trial will eventually occur, I’m sure, at least plenty of retrospective and probably approval.

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25.
What do we need from future innovations within the TAVR market? What would you like the next development to be?

SP: I think the attractiveness of the Medtronic supra-annular valve is nice but then you really fall into the problem of coronary access is one of the big downfalls that everybody talks about, so to have less of that problem with a super-annular platform would be nice. I think self-expanding devices are an excellent option. Obviously, the balloon-expandable platform has been shown to be excellent, so they really have both platforms already, which is wonderful. I think some type of way to pretty much make the pacemaker need zero would be great and I know that there’s an iteration of a valve that has a device that allows you to implant at the perfect depth.

I forget the name of that valve but I saw it at one of the conferences I went to, that it almost has a stopping footplate which doesn’t allow it to go too far into the LVOT and has an excellent placement. That could change a lot of things if the pacemaker rate was significantly reduced. Then stroke, stroke is obviously the next frontier. A lot of devices that are being tried, the Sentinel devices currently being used, we don’t have any other options here in the US but I know that there are some other options in Europe and that, having a low stroke rate, which we already do have which is good, but how many strokes really do we want? We really want zero, so some type of embolic protection device that works even better is always something that’s needed and wanted.

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