NIH Reports TAVI/TAVR as more routine, open to moderate risk patients, and then some

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jyg

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I know we had a post in this section from 2017, but this news from the NIH seems even brighter.

I should have another 5 years at least with my 6 year old Epic. By the time I get my bioprosthetic replaced, I imagine low-risk/asymtpomatic TAVR patients will be common. Now I had a blimp of an aortic aneurysm, so I needed a sternotomy in any case. But in the future, the thought of having an a new valve implanted intravenously with "conscious sedation" blows my mind! I don't go around worry or moping about it, but this is the first time I've felt truly positive about the future prospects of my AVR. Hopefully, it's warranted and you can rejoice a bit too.

In the 16 years since the first pioneering procedure, transcatheter aortic valve implantation (TAVI) has come of age and become a routine strategy for aortic valve replacement, increasingly performed under conscious sedation via transfemoral access. Simplification of the procedure, accumulation of clinical experience, and improvements in valve design and delivery systems have led to a dramatic reduction in complication rates. These advances have allowed transition to lower risk populations, and outcome data from the PARTNER 2A and SURTAVI trials have established a clear evidence base for use in intermediate risk patients. Ongoing studies with an expanding portfolio of devices seem destined to expand indications for TAVI towards lower risk, younger and asymptomatic populations. In this article, we outline recent advances, new devices and current guidelines informing the use of TAVI, and describe remaining uncertainties that need to be addressed.
jyg
 

pellicle

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Hi

I went on to read the article (the above link cites only the abstract for (here)), the details are important. When they say "younger" its important to ask "younger than what"

...The mean age was 82 years with a mean STS score of 5.8% ...

... SURTAVI enrolled 1746 intermediate risk patient... Patients were randomized to TAVI using the CoreValve system (CoreValve 84%, next generation Evolut R 16%) or SAVR. The mean age was 79.8 years..

... Notably, NOTION-2 is only enrolling patients <75 years and is therefore likely to report outcomes in the youngest TAVI population so far ...
As I often observe:
887256


I'm not sure if that's you any time soon. The usual question I ask first is "how long will it last and what happens then?"

However, given that long-term valve durability remains to be established, and redo valve procedures and coronary interventions following TAVI may be more challenging, its expanded use in younger populations must be supported by high quality clinical evidence. ...
They have a section which sets the standard:
Valve durability and function
Structural valve deterioration (SVD) is defined by permanent intrinsic changes of the valve (calcification, pannus, and leaflet failure) leading to degeneration and/or dysfunction, which in turn may result in valvular stenosis or intra-prosthetic regurgitation.41 The risk of SVD is heavily influenced by valve design and patient age at the time of implantation. Durable long-term outcomes have been reported for surgical bioprosthetic valves, but freedom from SVD at 15 years ranges from 67% in patients aged <60 years to 92% in patients >70 years
So 15 years ... this is discussed:
Concerns that transcatheter valves might suffer from early SVD have not so far materialized, with 5 years outcomes from PARTNER I showing that SVD requiring intervention is rare (∼0.2%).46 Moderate or severe transvalvular regurgitation developed in 3.7% after TAVI, increasing over time. In a multicentre registry study of 1521, TAVI patients over mean echocardiographic follow-up of 20 ± 13 months, 4.5% of patients developed an increase in mean transvalvular gradient of ≥10 mmHg, with a mean increase of 0.30 ± 4.99 mmHg/year
5 years ... I assume because in earlier trials the patient died of other causes (not unexpected for an 80 year old) and so we still lack data as they say:
While this medium term follow-up is reassuring, studies of surgical bioprostheses indicate that SVD before 10 years is rare, and continued close follow-up is essential to establish the long-term durability of transcatheter valves. By the early 2020s, data will be available for a relatively small number of patients who received first generation valves.
This last point seems a bit of a head wind:
Despite these improvements, global use of TAVI is patchy with several barriers to wider geographical use. First, device cost is currently prohibitive (>$30 000 in the USA) and international uptake correlates strongly with healthcare spend.16 Device costs have risen over time and seem unlikely to stabilize until, there are more competing valves available on the market.

so my view is that if you find yourself needing surgery in the next 5 to 10 years, TAVI would not be what I would suggest you choose unless I was the holder of your life insurance policy.
 

jyg

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Hi

I went on to read the article (the above link cites only the abstract for (here)), the details are important. When they say "younger" its important to ask "younger than what"
...
Thanks for going deeper Pellicle. If I understand the numbers, the valves themselves are holding up, but severe stenosis can develop within 5 years (using >40mmHg as a definition of severe AS). This is, as you point out the issue with patient age, even more concerning since older patients are slower to develop stenosis in bioprosthetic valves.

What I don't understand is the overall problem with $30k for the device. I would think TAVR would mean lower costs over all as it requires an entirely lower class of anesthesia and I would think shorter hospitalization and rehab. (And if it gets rid of younger AVR patients ever earlier, that's a huge savings for insurance companies :D )

Well, back to sulking ;)

jyg
 

pellicle

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Hi

Thanks for going deeper Pellicle.
welcome ... I was curious so read it ... as you know I'm now "no longer in the market" for a valve (or I bloody hope not).

If I understand the numbers, the valves themselves are holding up, but severe stenosis can develop within 5 years (using >40mmHg as a definition of severe AS). This is, as you point out the issue with patient age, even more concerning since older patients are slower to develop stenosis in bioprosthetic valves.
yeah, that matches my reading of the data. So as yet a TAVR is not comparable to a Standard AVR (SAVR ... fkkin acronyms geezeUz) and so with out data to plan with then your "event horizon" is at this point something over 5 years. I recall when doing some digging a while back for another fellow that it was: 5~7 years, then potential Valve In Valve (which being smaller diameter gives less time. Then SAVR to rectify that sludge pile. So you'd get to kick the can down the road say 11 years before facing OHS (if the higher stroke rates didn't cause issues and require you to be on warfarin (and then why wouldn't you take a mech and be done with it?).

What I don't understand is the overall problem with $30k for the device. I would think TAVR would mean lower costs over all as it requires an entirely lower class of anesthesia and I would think shorter hospitalization and rehab.
a mate of mine used to make catheters for a company (not heart valves, but other surgical tools), and the level of complexity is off the charts compared to something you can hold in your hand and deploy with your hands. Just think about making that ...

(And if it gets rid of younger AVR patients ever earlier, that's a huge savings for insurance companies :D )
putting my black hat on for a minute, its a tug of war between one industry wanting to make money and the other making money by saving it.

best wishes :)
 

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