TAVR Now FDA Approved for Intermediate Risk!

[neo]

Never thought we'd see the day, but TAVR has been proven safer than surgical VR and was FDA approved today for intermediate risk! This is great news for all of us, and is truly a game changer. Many exciting things going on in the world of valve replacement right now...

http://www.investors.com/news/technology/edwards-heart-valve-wins-expanded-fda-approval-stock-up/

http://www.nejm.org/doi/full/10.1056/NEJMoa1514616

 

[pellicle]

Hi

where did it say proven safer?

CoryP from here was one of the first I know who was "intermediate risk" that has had a TAVI

I think for younger patients with more than 20 years expectable life span its stupid; as the rating is for less time than a normal bioprosthetic and you can do valve in valve only once (which is again rated for less than the first) so by 15 years you'll be facing traditional OHS anyway

but this bit is promising:

RESULTS

The rate of death from any cause or disabling stroke was similar in the TAVR group and the surgery group (P=0.001 for noninferiority). At 2 years, the Kaplan–Meier event rates were 19.3% in the TAVR group and 21.1% in the surgery group (hazard ratio in the TAVR group, 0.89; 95% confidence interval [CI], 0.73 to 1.09; P=0.25). In the transfemoral-access cohort, TAVR resulted in a lower rate of death or disabling stroke than surgery (hazard ratio, 0.79; 95% CI, 0.62 to 1.00; P=0.05), whereas in the transthoracic-access cohort, outcomes were similar in the two groups. TAVR resulted in larger aortic-valve areas than did surgery and also resulted in lower rates of acute kidney injury, severe bleeding, and new-onset atrial fibrillation; surgery resulted in fewer major vascular complications and less paravalvular aortic regurgitation.

 

[neo]

Pellicle,

I think your quote from the New England Journal of Medicine answered why TAVR was safer for intermediate risk patients than surgery:

"At 2 years, the Kaplan–Meier event rates were 19.3% in the TAVR group and 21.1% in the surgery group"

"In the transfemoral-access cohort, TAVR resulted in a lower rate of death or disabling stroke than surgery"

"TAVR resulted in larger aortic-valve areas than did surgery and also resulted in lower rates of acute kidney injury, severe bleeding, and new-onset atrial fibrillation; surgery resulted in fewer major vascular complications and less paravalvular aortic regurgitation."

Promising indeed, thus the FDA approval. As far as Valve-in-Valve procedures go, how do you know that only one will be able to be done? A lot of that depends on the size of the valve. Sure, current guidelines may only suggest one Valve-in-Valve, but what happens when they start studying more than one? I doubt there would be any candidates right now to even test a double valve-in-valve. But if you think about it, why wouldn't it work, especially if you had the space?

Hi

where did it say proven safer?

CoryP from here was one of the first I know who was "intermediate risk" that has had a TAVI

I think for younger patients with more than 20 years expectable life span its stupid; as the rating is for less time than a normal bioprosthetic and you can do valve in valve only once (which is again rated for less than the first) so by 15 years you'll be facing traditional OHS anyway

but this bit is promising:

 

[pellicle]

Pellicle,

I think your quote from the New England Journal of Medicine answered why TAVR was safer for intermediate risk patients than surgery:

but only for a very select group. There are more questions than answers.

As far as Valve-in-Valve procedures go, how do you know that only one will be able to be done?

extensive discussions with CoryP in listening to his arguments and being a sounding board on his decision.

 

[neo]

Select groups being intermediate to high risk. If someone was low risk, perhaps it would be better to get the latest biologic valve, such as the St Jude Trifecta GT or Edwards Magna Ease. Open Heart isn't so bad the first time around. Low-risk person could then wait till the TAVR tissue got more durable, like with the studies being done on TAVR using stem-cell seeded tissue, before they had their valve-in-valve someday, hopefully decades later.

Who is CoryP? I'd like to check out your discussions. From what I've been told, from those in the field, is that many things like valve-in-valve will be done in the future using multiple stents etc. It takes a while before studies can come out showing these techniques to be safe, like in the NEJM, before they gain wide popularity.

but only for a very select group. There are more questions than answers.

extensive discussions with CoryP in listening to his arguments and being a sounding board on his decision.

 

[pellicle]

Select groups being intermediate to high risk

its surprising who gets classified as intermediate risk. CoryP is a mid 40's fellow who just didn't want a through the sternum this time

so when an intermediate risk is under 50 you have to ask questions about the risk assessments.

but still, its marketing not medicine (if you ask me) which drives this stuff.

As to who he is (you could search yourself, but here it is anyway)

http://www.valvereplacement.org/foru...urney-of-coryp

and our discussions were over 5 hours worth of my calling the USA on my phone (from Australia) to listen and advise. An enthusiastic TAVI researcher should be able to dig out if what he's told me is correct or not.

If you are genuinely wanting this for yourself and want to speak with him PM me and I'll pass on your details. You could also PM him, but to be honest he seems to not bother here now that he's made his decision. I expect we'll next hear from him when there is a crisis ... at least that's how it panned out last time.

 

[Agian]

Great news for older patients.
TAVI in a younger person might buy time before the next great thing, but what happens to the calcium? Does it just get pushed to the side?
Apparently, I had a massive spike of calcium creeping up towards one of the mitral cusps. This was removed by the surgeon.

 

[neo]

I would ask the Cardiologist if calcium is of concern before making a decision to go through this. This was FDA approved for those with severe aortic stenosis of intermediate to high risk, and proved to be safer than surgery. Many people with AS have calcification, so the stent must mitigate the risk somehow, pushing the calcified tissue off to the side somehow.

It seems like, if someone got a newer generation tissue valve and got 20 years out of it... Then a valve-in-valve for an additional 10-20 years... That would be a great period of time before the next great thing is being used.

Great news for older patients.
TAVI in a younger person might buy time before the next great thing, but what happens to the calcium? Does it just get pushed to the side?
Apparently, I had a massive spike of calcium creeping up towards one of the mitral cusps. This was removed by the surgeon.

 

[Twobike]

I'm still waiting to find out if I get the TAVR. It's a low risk over 65 yo study. That's the way I want to go! My wife thinks open heart would be best, so if trouble later in life I could go for the TAVR. I'm 72 yo. Either way, since it's a study, I don't get to choose.

 

[neo]

Thanks Pellicle... Looks like CoryP had a great experience. His thoughts about valve-in-valve appear to be just questions and speculation. We have no idea how many valve-in-valves will be able to be done, or how it will affect flow, until those studies and first eligible patients have gone through it.

I would imagine, speculate myself, that the bigger the valve, the more valves you could fit inside it. Notice that the next generation TAVRs keep getting thinner and thinner... And repositionable.

its surprising who gets classified as intermediate risk. CoryP is a mid 40's fellow who just didn't want a through the sternum this time

so when an intermediate risk is under 50 you have to ask questions about the risk assessments.

but still, its marketing not medicine (if you ask me) which drives this stuff.

As to who he is (you could search yourself, but here it is anyway)

http://www.valvereplacement.org/foru...urney-of-coryp

and our discussions were over 5 hours worth of my calling the USA on my phone (from Australia) to listen and advise. An enthusiastic TAVI researcher should be able to dig out if what he's told me is correct or not.

If you are genuinely wanting this for yourself and want to speak with him PM me and I'll pass on your details. You could also PM him, but to be honest he seems to not bother here now that he's made his decision. I expect we'll next hear from him when there is a crisis ... at least that's how it panned out last time.

 

[neo]

Interesting you're part of a low-risk study! Just shows where valve-replacement is going. I'm sure you will be happy whatever way you go... It will certainly make you feel better than you do now! Good luck

I'm still waiting to find out if I get the TAVR. It's a low risk over 65 yo study. That's the way I want to go! My wife thinks open heart would be best, so if trouble later in life I could go for the TAVR. I'm 72 yo. Either way, since it's a study, I don't get to choose.

 

[neo]

Another thing I've been told, from those in the field, is that the valve stent does not have to be positioned directly inside the failing valve. Again, this is speculation l, but you could theoretically position the TAVR further up, in the ascending aorta, or perhaps behind the valve after the failing valve had been opened up to allow flow. I'm sure they will be looking at many options

Thanks Pellicle... Looks like CoryP had a great experience. His thoughts about valve-in-valve appear to be just questions and speculation. We have no idea how many valve-in-valves will be able to be done, or how it will affect flow, until those studies and first eligible patients have gone through it.

I would imagine, speculate myself, that the bigger the valve, the more valves you could fit inside it. Notice that the next generation TAVRs keep getting thinner and thinner... And repositionable.

 

[Paleowoman]

but what happens to the calcium? Does it just get pushed to the side?

I think it might get pushed to the side undereath the stent holding the new valve, BUT my understanding is that the higher risk of stroke post AVR is due to bits of calcification breaking off. When you have open heart surgery the surgeon carefully removes all the calcification.

I personally wouldn't want a TAVR as they are at the moment - I would want to wait until they have longevity studies with them. So far they've only been used in high risk patients who are elderly. Maybe when the people in the up and coming studies have lived a significant number of years (15 ? 20 ?) then it will have proven itself as a good alternative to open heart surgery.

My bioprosthetic valve is 19mm. I understand they won't do valve in valve with that small size, but thankfully I personally wasn't planning on valve in valve when I need a re-do even though the re-do will be a big pain.

 

[neo]

Just found a great article explaining all of this, see link below.

"In April, Edwards demonstrated exactly that through its 2,000-person study of patients with "intermediate risk" of complications from surgery. Within 30 days of the procedure, 1.1% of patients treated with TAVR died compared with 4% of patients who'd received surgical valve replacement. After a year, the death rate was 7.4% in the TAVR group and 13% in the surgery group. A similar contrast appeared in the prevalence of stroke."

http://www.investors.com/research/th...heart-surgery/

 

[Paleowoman]

Just found a great article explaining all of this, see link below.

"In April, Edwards demonstrated exactly that through its 2,000-person study of patients with "intermediate risk" of complications from surgery. Within 30 days of the procedure, 1.1% of patients treated with TAVR died compared with 4% of patients who'd received surgical valve replacement. After a year, the death rate was 7.4% in the TAVR group and 13% in the surgery group. A similar contrast appeared in the prevalence of stroke."

http://www.investors.com/research/th...heart-surgery/[/URL

4% death rate within 30 days with surgical valve replacement ! 13% death rate after a year with surgical valve replacement ! They call those patients “intermediate” risk patients !?!? Let’s see the figures with the ages and co-morbities of those patients, plus the reasons why they are having valve replacement ! I read the link and couldn't find the figures.

 

[neo]

It would be interesting to see what qualifies as an intermediate risk patient

 

[Nocturne]

Here's a fun fact:

Above the age of 75 or so, AVR recipients actually have BETTER longevity, on average, than their age-matched cohort. This is because the ones who get the surgery are the ones deemed healthy enough to survive OHS, whereas many if not most in their age-matched cohort are not. So there is a selection bias.

With the adoption and proliferation of TAVR, less healthy men in their 70s will be able to get AVR, and we can thus expect the selection bias to fade (if not vanish) and for average longevity after AVR in that age group to go DOWN -- which will be a GOOD thing, but not obviously so.