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

[jyg]

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.

https://www.ncbi.nlm.nih.gov/pubmed/29718148​

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]

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:

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]

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 )

Well, back to sulking

jyg

 

[pellicle]

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 )

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

 

[Warrick]

Interesting article puts a less than rosey spin on things-
https://khn.org/news/reports-of-patients-deaths-linked-to-heart-devices-lurk-below-radar/

 

[tom in MO]

Reporting of valve problems is complicated. TAVR deaths could be related to a host of other illnesses given the patients are knocking at death's door just to qualify for the initial trials. Would be hard to weed out deaths that are just valve related. With newer patients being younger, the "tale of the tape" will tell after 10-20 years.

Reporting of adverse incidents is also complicated in anticoagulation therapy. If someone with a mechanical valve gets a stroke, they immediately blame the mechanical valve and warfarin, but it could very well be another problem caused the stroke. The autopsy rate in US hospitals is less than 5%.

 

[pellicle]

Reporting of adverse incidents is also complicated in anticoagulation therapy. If someone with a mechanical valve gets a stroke, they immediately blame the mechanical valve and warfarin, but it could very well be another problem caused the stroke .

Interesting point, hadn't thought about it before, but yes, probably exactly that.

 

[tom in MO]

Interesting point, hadn't thought about it before, but yes, probably exactly that.

I read that in an article on anticoagulation.

 

[bizinsider]

All of which raises yet another question: TAVAR (sorry, Pellicle) for replacement of the ascending aorta or even the aortic arch. I am told that when my time comes (and it appears to be fast-approaching) I could be a lucky winner for having the whole shebang done - BAV, root, AA and (drumroll) arch. At least that's what my cardiologist was saying -- implying that it's best to do it all now rather than risk another surgery down the road if and when the arch need it. (the proximal is slightly dilated.) I saw a Mayo video that suggested it all be done at once. THEN I saw a video from a recent surgery in – I think it was Texas – where there are trials for doing the arch not only without the need to surgically open the chest, but cool the brain and stop the heart. So when I do my surgeon consulting, which I think will be soon with Dr. Svensson in Cleveland – if he thinks it's time for an in-person visit – I intend on asking whether it could be worth waiting on the arch until TAVAR is a real thing. Having the arch replaced, even if by a hemiarch procedure (not the whole thing) certainly got my attention!

 

[pellicle]

TAVAR (sorry, Pellicle)

??
Everyone can say what they want. Nobody needs worry about me, you don't need to worry about me. I won't ever be a candidate.

I mainly concern myself with helping with AC therapy and clearing up misconceptions about that.

PS: what was the question?

 

[tom in MO]

All of which raises yet another question: TAVAR (sorry, Pellicle) for replacement of the ascending aorta or even the aortic arch. I am told that when my time comes (and it appears to be fast-approaching) I could be a lucky winner for having the whole shebang done - BAV, root, AA and (drumroll) arch. At least that's what my cardiologist was saying -- implying that it's best to do it all now rather than risk another surgery down the road if and when the arch need it. (the proximal is slightly dilated.) I saw a Mayo video that suggested it all be done at once. THEN I saw a video from a recent surgery in – I think it was Texas – where there are trials for doing the arch not only without the need to surgically open the chest, but cool the brain and stop the heart. So when I do my surgeon consulting, which I think will be soon with Dr. Svensson in Cleveland – if he thinks it's time for an in-person visit – I intend on asking whether it could be worth waiting on the arch until TAVAR is a real thing. Having the arch replaced, even if by a hemiarch procedure (not the whole thing) certainly got my attention!

You seem to be risk averse, (i.e., going to Cleveland when you live in San Diego,) so just curious, why would you want an experimental procedure as opposed to one that is proven?

 

[Suckyvalvegurl]

Bizinsider - do a little research on Dr. Doolahb at UTSW in Texas. I had true minimally invasive AVR with him and I was very pleased. If you want his nurses email let me know. I don't want to just post it. They are great about letting you email your echo report etc and giving you an idea of whether or not yours can be done this way. He is in the top 3% of CV surgeons.

 

[elMIguel]

Suckyvalvegurl- I‘m having my consult with Dr. Doolabh tomorrow afternoon provided my local hospital gets the TEE and echo results to him by then. I hope my experience goes as smoothly as yours.

 

[Suckyvalvegurl]

Awesome! Please update me. Next month will be 2 years post OP and I couldn't be more pleased.

 

[pellicle]

All of which raises yet another question: TAVAR (sorry, Pellicle

No apology needed

 

[bizinsider]

No apology needed

You're the best, Pellicile. Totally missed the fuss I stirred! Genuinely sorry about causing a fuss!!! Two months from those posts I was already opened, closed and on the mend. Things moved too fast to consider anything but what I had done.

 

[pellicle]

Totally missed the fuss I stirred!

me too ... but anyway. glad your on the mend and doing well

Things moved too fast to consider anything but what I had done.

and the end of the day its all about your situation ... unless I'm asking, then its about me ;-)

Best Wishes

 

[bizinsider]

unless I'm asking, then its about me ;-)

God love you Aussies.

 

[pellicle]

God love you Aussies.

And today is our National day
Strya!

 

[bobco70]

Bizinsider - do a little research on Dr. Doolahb at UTSW in Texas. I had true minimally invasive AVR with him and I was very pleased. If you want his nurses email let me know. I don't want to just post it. They are great about letting you email your echo report etc and giving you an idea of whether or not yours can be done this way. He is in the top 3% of CV surgeons.

Does he do 2nd AVRs? How do I contact his nurse? Thx Bob