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TAVR Durability & Strategic Planning: What Health System Leaders Need to Know · Becker’s Healthcare Podcast

• 0:00
  - Hi, everyone. This is Lucas Voss with Becker's
• 0:02
  - Healthcare. Thanks so much for tuning in to
• 0:05
  - the Becker's Healthcare podcast series. It's great to
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  - have you. Today, we're talking to you about
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  - TAVR durability and strategic
• 0:11
  - planning, what health system leaders need to know.
• 0:15
  - Nobody better to have
• 0:17
  - for this conversation.
• 0:19
  - Doctor Curtis Stennis, he's the clinical professor of
• 0:22
  - medicine, director of peripheral interventions and interventional cardiology
• 0:26
  - at Scripps Clinic. Doctor Stennis, so great to
• 0:28
  - have you on. Thanks for being here. Thanks
• 0:30
  - Thanks so much for having me, Lucas.
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  - I wanna start off with introductions. I know
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  - I just mentioned your title, but I'd love
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  - to hear a little bit more about your
• 0:37
  - work and your career.
• 0:39
  - Oh, yeah. Sure. Well, I'm a interventional cardiologist.
• 0:43
  - I've been doing this now for, gosh,
• 0:45
  - getting close to twenty years now.
• 0:48
  - So I've been privileged to be involved with
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  - the TAVR space since its inception in The
• 0:53
  - United States back in 2008 when we did
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  - the, you know, very first clinical trials back
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  - then. So been part of it since that
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  - time and fair amount of experience.
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  - We'll touch on that here in a little
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  - bit. I wanna level set the conversation for
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  - our audience just a little bit. Right?
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  - Can you walk us through
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  - the most recent durability data for the two
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  - dominant TAVR platforms, and what does does that
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  - data
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  - tell platforms,
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  - and what does does that data tell us
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  - about where the landscape is right now?
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  - Yeah. Sure. So the two dominant platforms in
• 1:24
  - The United States are, of course, the balloon
• 1:26
  - expandable Edwards Sapien valve and the self expanding,
• 1:30
  - Medtronic Evolut valve. And, you know, when TAVR
• 1:32
  - first started, you know, we were primarily focused
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  - on very high risk patients that didn't have
• 1:36
  - other options like surgery.
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  - And, obviously, as time has gone on, we've,
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  - you know, done clinical trials on patients that
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  - are candidates for surgery, and so directly comparing
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  - these devices to surgery is is important. And,
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  - you know, long term, when we're treating younger
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  - and healthier patients, we have to think about
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  - how long will these devices last, And we
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  - really didn't have a lot of information about
• 1:57
  - that until the last few years.
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  - But this year, we got some landmark data
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  - back.
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  - So, you know, these devices have been studied
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  - in various populations,
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  - including, you know, what are called intermediate risk
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  - surgical patients and low risk surgical patients.
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  - And within the last year, we've received data
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  - of on ten years' worth of the intermediate
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  - risk patients compared to surgery as well as
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  - seven years six and seven years, I should
• 2:22
  - say,
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  - between these devices and surgery.
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  - To summarize, there's a big difference here in
• 2:27
  - these in these devices.
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  - The self expanding platform, which uses porcine pericardium,
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  - doesn't seem to be as durable.
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  - Recently, the, Evolut low risk trial data was
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  - presented, which showed that right around five to
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  - six years,
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  - we start to see failures of the TAVR
• 2:43
  - device. And by year seven, there's definitely significant,
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  - failure of these devices primarily due to aortic
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  - insufficiency,
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  - likely due to the material, the the leaflet
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  - tissue,
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  - sort of tearing and and, and falling apart.
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  - And those patients in that trial required, you
• 2:59
  - know, more interventions
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  - either with redo,
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  - TAVR or with surgery.
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  - On the other hand, if you look at
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  - the balloon expandable valve data, specifically with the
• 3:08
  - Edwards Sapien device,
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  - in the low risk patient population at seven
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  - years, there's no difference in, you know, a
• 3:15
  - durability between the surgical arm and the TAVR
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  - arm. They're pretty much exactly identical.
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  - And that actually pans out with the intermediate
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  - risk patients at ten years as well, that
• 3:24
  - TAVR durability at ten years for intermediate risk
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  - patients looks identical to surgery. So there's really
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  - a distinction or a difference between these devices.
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  - Is that then
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  - a Teva class effect?
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  - And when you're looking at this data, almost
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  - again, like in some cases, a decade close
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  - to a decade of data now, what are
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  - some of the common myths the data then
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  - challenges?
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  - Yeah. I think it's really important to realize
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  - that this is device specific durability data and
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  - not a judgment on TAVR as a therapy
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  - as a whole. You know, I've I've heard
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  - a lot of myths out there
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  - saying, well, you know, hey, TAVR doesn't work.
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  - It only lasts five or six six years,
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  - and here's the data to show that. And
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  - that's simply not true.
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  - That TAVR is not a class effect, that
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  - there's definitely differences in these devices. Similar to
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  - surgery, there have been some surgical valves that
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  - had early failure rates. And, you know, simply
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  - saying, well, surgery doesn't work based on that
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  - situation would be untrue. And I think it's
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  - really important to to
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  - distinguish the fact that these devices are distinctly
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  - different. Their their design is different. The tissue
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  - is different. And, clearly, we now know the
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  - durability is different.
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  - And I wanna talk a little bit about
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  - more
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  - the of the the durability piece of this
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  - because I think that's it's very, very important.
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  - What does that data then, that durability data
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  - tell us about clinical outcomes and then also
• 4:42
  - long term patient care? And certainly, you've just
• 4:45
  - touched on it, that lifetime valve management piece.
• 4:48
  - Yeah. I think that's critical. And and as
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  - I mentioned earlier, if we're treating younger or
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  - healthier people, they're going to outlive these valves.
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  - We know that all bioprosthetic valves eventually will
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  - wear out or degenerate at some point in
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  - the patient's, you know, lifespan. So
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  - younger and healthier folks are going to end
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  - up needing a redo procedure of some type.
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  - What we can quote the what we can
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  - gather from the data from the Evolut low
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  - risk trial in particular
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  - is that around six and seven years when
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  - we see this increased failure rate due to
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  - aortic insufficiency,
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  - some of those patients were able to be
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  - treated with a new valve, a new TAVR
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  - valve, if you will, so called valve in
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  - valve. But sadly, many of them required surgery,
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  - to explant the TAVR valve. And what we
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  - know from the literature is that surgical explantation
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  - of TAVR valve is higher risk and more
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  - complex
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  - than standard surgical a v aortic valve replacement.
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  - In addition,
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  - importantly, that we can we can also see
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  - from the data is that many of these
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  - patients when the valve failed required an urgent
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  - or emergent and even salvage type procedure. About
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  - fifty percent of them required urgent, emergent, or
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  - salvage type procedures in total.
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  - And that puts a lot of burden on
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  - the health care system. Right? These are sicker
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  - people coming through the doors of the hospital
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  - requiring, you know, potentially more intensive care, longer
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  - days in the hospital, and a more complex
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  - and high risk intervention,
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  - whether it be a TAVR valve in valve
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  - or a surgical,
• 6:13
  - you know, explantation and surgical, valve replacement. So
• 6:17
  - these are sicker people requiring more resources from
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  - the health care, system, and ultimately,
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  - that's a more challenging subset of patients to
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  - deal with in health care.
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  - I wanna talk a little bit more about
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  - this trickle down effect that you've just outlined
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  - very effectively because I think it's very important
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  - when we're looking at, again, the health system
• 6:35
  - health care as a as a whole. How
• 6:37
  - does valve durability then and and certainly the
• 6:39
  - need for replacement too
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  - affect hospital quality, cost, and then also operational
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  - complexity?
• 6:46
  - Yeah. No. For sure. And, you know, as
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  - I mentioned earlier, valve design makes a difference
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  - not just in durability Yeah. But also in
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  - repeatability.
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  - So with the self expanding,
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  - Evolut platform,
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  - sort of claim to fame to that product
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  - is having a so called supraannular
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  - design, meaning the leaflets are sort of higher
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  - up in the frame to improve hemodynamics,
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  - with the intent of improving durability, which we
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  - now know is not directly linked. This improved
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  - hemodynamics or better hemodynamics by echo does not
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  - directly correlate with durability, certainly. But these valves
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  - can be harder to treat from a valve
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  - in valve perspective
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  - with a redo TAVR. And the reason for
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  - that is because those leaflets are higher in
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  - the frame, there's a higher likelihood of coronary
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  - obstruction.
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  - And this means that these procedures are more
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  - technically challenging and often require adjunctive therapies
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  - like leaflet modification,
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  - for example.
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  - And there are there are ways that the
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  - leaflets can be modified either with sort of
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  - home brew, methods of using various wires that
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  - we electrify and whatnot
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  - or a dedicated device known as the shortcut
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  - device, which is now, available by FDA approval
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  - in The US. But these these devices increase
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  - cost dramatically,
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  - increase the length of the procedure, which therefore
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  - increases cost, and, of course, because they're more
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  - complex,
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  - require additional adjunctive
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  - therapies like cerebral protection,
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  - longer hospital stays, etcetera. So that increases cost,
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  - burden to the health care system,
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  - for sure.
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  - Doctor Stennis, it's so great to have you.
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  - One of the things that I've just gathered
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  - from your responses that that's something to keep
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  - in mind, the trickle down effect. It's very,
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  - very crucial,
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  - for leaders, to keep in mind both for
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  - cardiovascular leaders, but also health system executives.
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  - As we close our conversation, what are some
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  - of those key takeaways that you want cardiovascular
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  - leaders and certainly, again, those health system leaders,
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  - remind of and that what do they need
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  - to know and how should this data that
• 8:41
  - we now have
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  - shape their thinking on
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  - valve selection and valve in valve planning?
• 8:48
  - Yeah. So, I mean, valve choice the first
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  - valve choice has absolute implications for lifetime management
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  - for these patients, and they're, therefore, also a
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  - direct implication for the health care systems that
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  - are going to be handling or taking care
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  - of these folks when that valve, you know,
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  - fails.
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  - Executives certainly don't choose valves, but they are
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  - responsible for outcomes and access and sustainability in
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  - their program. And so, you know, we have
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  - seen some facilities that have contracting issues or
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  - whatnot with certain valves, and that may limit
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  - options available to physicians at those institutions. And
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  - so I think executives
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  - should realize that TAVR is not a class
• 9:23
  - effect, that there are differences in these devices,
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  - and that it's important to allow the physician
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  - to choose, you know, options which, you know,
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  - would may provide the best option or solution
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  - for that patient both now and in the
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  - future. I think it's it's you know, executive
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  - awareness is essential to support informed physician discussions,
• 9:39
  - patient counseling, and long term care strategy.
• 9:42
  - Doctor Stennis, so great to have you. Thanks
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  - so much for spending some time with us.
• 9:46
  - Of course. My pleasure. Thanks for having me,
• 9:47
  - Lucas. And we also want to thank our
• 9:49
  - podcast sponsor, Edwards Lifesciences. You can tune in
• 9:51
  - to more podcasts from Becker's Healthcare by visiting
• 9:54
  - our podcast page at beckershospitalreview.com.