a different perspective on TAVI

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pellicle

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todays reading led me to here

entitled: Surgeons caution against overenthusiasm for TAVI in light of PARTNER A stroke data Dr Craig Miller (Stanford University, CA)

I thought the following observations were interesting:
Because of the added neurological risk, Miller believes TAVI should not replace surgery for most patients who can withstand surgery. So he is dismayed that it has grown so rapidly in some European countries where TAVI devices are commercially available, even though the durability of these devices has not been proven. "This is not going to be cost-effective, and civilization cannot afford this if they do not last a good amount of time, and a good amount of time would mean something different to a 95-year-old who is inoperable and to somebody under 70 with a very low surgical risk who should have 10- to 20-year life expectancy. So we have to look at valve durability," he said.
{my underline}

and my thoughts are : or indeed a 40 year old with perhaps a >30 year life expectancy

I am simply attempting to bring different views of the issue.
 

epstns

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That's a very good point. One must take all of the circumstances into consideration, and we hope that the medical device manufacturers will not push these valves on people until or unless they can be further developed to attain a reasonable usable lifespan.

That said, I hope their research continues, as that is how the current crop of tissue valves came about. Originally they did not have the durability of the mechanicals, and were poor choices. Now, they are much better and are a good choice for many. This may be in the future, if TAVI valves can be developed further.
 

pellicle

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the manufacturers will not push these valves on people until or unless they can be further developed to attain a reasonable usable lifespan....
or consumers clamouring for them ... and the cycle of surgeons bowing to "informed patient desire" producing a pressure.

That said, I hope their research continues, as that is how the current crop of tissue valves came about.
100% totally agree. :)
 

Roberta

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I concur.

Although it is exciting to see things moving forward, and those who cannot withstand OHS now have an option, I would hope that the medical experts would wait until the clinical studies are out to validate when it is 'safe' to use TAVI in those who are lower risk. I believe it is incumbant on the surgeon to keep abreast of the current data and provide patients with a realistic recommendation for their individual specific case.

On another note, it is great to see that transcather valve replacement has been used as a viable and safe option for those with pulmonary issues (case by case) over the past 10 years. I know Lyn can speak to that better than me. It will be interesting to see how things evolve with TAVI in the aortic position and whether it becomes mainstream.

Pellicle, will check out the link . Thanks.
 

Lynlw

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I concur.

Although it is exciting to see things moving forward, and those who cannot withstand OHS now have an option, I would hope that the medical experts would wait until the clinical studies are out to validate when it is 'safe' to use TAVI in those who are lower risk. I believe it is incumbant on the surgeon to keep abreast of the current data and provide patients with a realistic recommendation for their individual specific case.

On another note, it is great to see that transcather valve replacement has been used as a viable and safe option for those with pulmonary issues (case by case) over the past 10 years. I know Lyn can speak to that better than me. It will be interesting to see how things evolve with TAVI in the aortic position and whether it becomes mainstream.

Pellicle, will check out the link . Thanks.
That's a very good point. One must take all of the circumstances into consideration, and we hope that the medical device manufacturers will not push these valves on people until or unless they can be further developed to attain a reasonable usable lifespan.

That said, I hope their research continues, as that is how the current crop of tissue valves came about. Originally they did not have the durability of the mechanicals, and were poor choices. Now, they are much better and are a good choice for many. This may be in the future, if TAVI valves can be developed further.
FIRST I agree, the more improvements on the percutaneous valves and their deployment systems the better (smaller, repositionable ), also the trials on younger and healthier people need to be done, to learn more about how they will do longer term or what problems show up down the road. Since there are so many companies spending millions of dollars on TAVI valve systems HOPEFULLY things will keep improving like they have been. The U.S. Trial of SAPIEN 3 Valve for Intermediate Risk Patients that has just been started will be good to watch.

BUT He (Miller) did NOT say the TAVI Valves were NOT durable (and more specifically, the 1st generation Sapien Valve in the PARTNER A trial he was discussing) when the first set of results of the PARTNER A trials were reported in 2011, 3 years ago, he said
" even though the durability of these devices has not been proven."
simply because they hadn't been in patients many years (2-3? years) at that time in the PARTNER trials, altho they were in a little longer in Europe.

Also as has been pointed out, there IS a learning curve to percutaneous Valves, in the first Partner trial results, that Miller is discussing for many centers the Partner trial was the first TAVI valve the doctors implanted, a few doctors had done a couple before, but like the experience in Europe when they first started TAVI valves, the rates of stroke and other problems declined quite a bit as the doctors did more valves and gained experience..

Since then (2011) the good news is, in the earliest generation Sapien valves at 5 years they were still doing great. Also since then they already have improved valves (sapien and other brands especially Corevalve in the US ) sheaths and deployment systems. I believe they currently are doing trials in the 4th generation Sapien and deployment systems are much smaller, that helps w/ some of the damage the first valves did on the frailer veins and arteries. I think it has been about 10 years now since the first percutaneous AORTIC valves were used world wide. Pulmonary are close to 15 years now, if Im remembering correctly. . Since there have already been 60,000 TAVI (Aortic) valves placed world wide, hopefully we will have quite a bit of data in a few years.

As for the valves themselves, and POSSIBLE longevity, for the most part especially Edwards Sapien, the leaflets are the same as their surgical tissue valves (perimount). The difference is instead of the treated pericardial tissue being sewn on to a large sewing ring that is sewn into the person, the pericardial tissue is sewn onto thinner stents that are placed like other stents are. (that is also why for the most part they have better hemodynamics than SAVR) I Would think,IMO if there was a problem because they are on stents that would be showing up by now, so the fact they are still doing well and in place 5 or so years is a good sign. Since the tissue is like surgical tissue valves, HOPEFULLY they will last as long as the current tissue valves, of course only time will tell. FWIW the Melody pulmonary cath valve is used in very young (children 20s, etc) patients and so far the cath valves are doing well. The pulmonary valve doesnt have as much pressure going thru it as Aortic, BUT they are used in VERY active children who run and play sports, just like the young people w/ surgical tissue valves.

I personally believe it will be years before the FDA approves TAVI valves for a first time Aortic valve in a healthy 40 year old, BUT since they already can place a Cath valve inside another cath valve it is POSSIBLE w/ what is known today, not in a far off future, That a 40 something person who chose a tissue valve today, by the time they need a REDO it is quite possible, they will be a candidate for a TAVI Valve in Valve, so it is POSSIBLE (don't count on it when choosing a valve right now) they would only need 1 open heart surgery.

OF course when the time comes, they may choose a different surgical valve that is better than the valves available today, either improved mech valves that wouldn't need anticoagulant, or tissue valves grown from their own cells that should last a lifetime or even safer anticoagulants...OR its possible the choices will be exactly the same they are now. That is one of the hard things so many exciting things are being done, but it is still too earlier to bet on any of it.

One thing I think is very important and rarely hear discussed, is IF you choose a tissue valve, (at any age) I would talk to the surgeons about if they know which, if any, of tissue valves in use today would make it a better chance (or worse chance) of having a TAVI valve placed inside it if /when this valve needs replaced. I think it would stink to find out your chance of having a Valve in Valve are not good, just because the tissue valve you have makes it more difficult than another Brand would that was available at the time they got their tissue valve.. OF course Valves that are not as easy as other valves to have the CURRENT TAVI valves placed inside, might be easier for future VinVs. But my guess would be the valves the easiest now, will still be candidates for VinV in the future, so I wouldnt worry much about tissue valves anyone already has. Things are getting better yearly it seems.
 
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Rachel

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I am also very glad that improvements are being made.....but I'm still a fan of the OHS method - kinda expecting that my next one will be the "full monty" anyway.
 

neil

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may sound odd but i prefer the ohs surgery myself, if there are gonna replace my valve i would rather them get full access to everything, but i also think its great that this option could be open to everybody in the future
 

Roberta

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FIRST I agree, the more improvements on the percutaneous valves and their deployment systems the better (smaller, repositionable ), also the trials on younger and healthier people need to be done, to learn more about how they will do longer term or what problems show up down the road. Since there are so many companies spending millions of dollars on TAVI valve systems HOPEFULLY things will keep improving like they have been. The U.S. Trial of SAPIEN 3 Valve for Intermediate Risk Patients that has just been started will be good to watch.

BUT He (Miller) did NOT say the TAVI Valves were NOT durable (and more specifically, the 1st generation Sapien Valve in the PARTNER A trial he was discussing) when the first set of results of the PARTNER A trials were reported in 2011, 3 years ago, he said simply because they hadn't been in patients many years (2-3? years) at that time in the PARTNER trials, altho they were in a little longer in Europe.

Also as has been pointed out, there IS a learning curve to percutaneous Valves, in the first Partner trial results,that Miller is discussing for many centers the Partner trial was the first TAVI valve the doctors implanted, a few doctors had done a couple before , but like the experience in Europe when they first started TAVI valves, the rates of stroke and other problems declined quite a bit as the doctors did more valves and gained experience..

Since then (2011) the good news is, in the earliest generation Sapien valves at 5 years they were still doing great. Also since then they already have improved both valves (sapien and other brands especially Corevalve in the US ) sheaths and deployment systems, I believe they currently are doing trials in the 4th generation Sapien and deployment systems are much smaller, that helps w/ some of the damage the first valves did on the frailer veins and arteries. I think it has been about 10 years now since the first percutaneous AORTIC valves were used world wide. Pulmonary are close to 15 years now, if Im remembering correctly. . Since there have already been 60,000 TAVI (Aortic) valves placed world wide, hopefully we will have quite a bit of data in a few years.

As for the valves themselves, and POSSIBLE longevity, for the most part especially Edwards Sapien, the leaflets are the same as their surgical tissue valves (perimount). The difference is instead of the treated pericardial tissue being sewn on to a large sewing ring that is sewn into the person, the pericardial tissue is sewn onto thinner stents that are placed like other stents are. (that is also why for the most part they have better hemodynamics than SAVR) I Would think,IMO if there was a problem because they are on stents that would be showing up by now, so the fact they are still doing well and in place 5 or so years is a good sign. Since the tissue is like surgical tissue valves, HOPEFULLY they will last as long as the current tissue valves, of course only time will tell. FWIW the Melody pulmonary valve is used in very young (children 20s,etc) patients and so far the tissue valves are doing well. The pulmonary valve doesnt have as much pressure going thru it as Aortic, BUT they are used in VERY active children who run and play sports, just like the young people w/ surgical tissue valves.

I personally believe it will be years before the FDA approves TAVI valves for a first time Aortic valve in a healthy 40 year old, BUT since they already can place a Cath valve inside another cath valve it is POSSIBLE w/ what is known today,not in a far off future, That a 40 something person who chose a tissue valve today, by the time they need a REDO it is quite possible, they will be a candidate for a TAVI Valve in Valve, so it is POSSIBLE (don't count on it when choosing a valve right now) they would only need 1 open heart surgery.
OF course when the time comes, they may choose a different surgical valve that is better than the valves available today, either improved mech valves that wouldn't need anticoagulant, or tissue valves grown from their own cells that should last a lifetime or even safer anticoagulants...OR its possible the choices will be exactly the same they are now. That is one of the hard things so many exciting things are being done, but it is still too earlier to bet on any of it.

One thing I think is very important and rarely hear discussed, is IF you choose a tissue valve, (at any age) I would talk to the surgeons about if they know which, if any, of tissue valves in use today would make it a better chance (or worse chance) of having a TAVI valve placed inside it if /when this valve needs replaced. I think it would stink to find out your chance of having a Valve in Valve are not good, just because the tissue valve you have makes it more difficult than another Brand would that was available at the time they got their tissue valve.. OF course Valves that are not as easy as other valves to have the CURRENT TAVI valves placed inside, might be easier for future VinVs. But my guess would be the valves the easiest now, will still be candidates for VinV in the future, so I wouldnt worry much about tissue valves anyone already has. Things are getting better yearly it seems.
Lyn,

Great synopsis...thank you.
 

Roberta

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or consumers clamouring for them ... and the cycle of surgeons bowing to "informed patient desire" producing a pressure.

I wonder if that would go against the Hypocratic oath of do no harm? I personally would hope that my surgeon would not be bowing to my pressure of wanting a certain procedure done, if he/she believed it did more harm than good to me. Just my two cent
 

ottagal

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One thing I think is very important and rarely hear discussed, is IF you choose a tissue valve, (at any age) I would talk to the surgeons about if they know which, if any, of tissue valves in use today would make it a better chance (or worse chance) of having a TAVI valve placed inside it if /when this valve needs replaced. .
That is a very good point you are making Lyn. Thanks for bringing this up. My understanding is the tissue valve would also need to meet a certain minimal size criteria for it to be eligible for a future valve in valve procedure (assuming it would be mainstream by then)...at least that is what my surgeon had said a few years ago. I don't know if the criteria has changed since then..
 
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Gail in Ca

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Thanks, Pellicle.
Someday I want to write a book in response to your 3 sentence post!
I know Dr. Miller has tons of experience and is well published. He has seen a lot in his many years of OHS.
I believe he knows of what he speaks and wouldn't put it out there unless he was concerned.
How's that?
 

river-wear

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Lyn, you said "...BUT since they already can place a Cath valve inside another cath valve..." I've heard of cath inside a regular tissue valve, but not two cath-placed valves. Do you have a source for that?

I've seen references in various places saying that the durability of TAVI valves is still largely unknown, as they have only been used in very sick patients who usually die of other causes within five years or so. I personally would not count on one preventing a future OHS, but obviously the technology looks quite promising. There's a company that's working on a TAVI valve that would allow the exchange of valves via catheter. http://www.valvexchange.com/products/index.html

Their site is for marketing their technology of course, but I still found the discussion on the pros and cons of existing valve choices interesting - including some of the drawbacks of TAVI:
http://www.valvexchange.com/patients/index.html#patientsdilemma
 

ottagal

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Lyn, you said "...BUT since they already can place a Cath valve inside another cath valve..." I've heard of cath inside a regular tissue valve, but not two cath-placed valves. Do you have a source for that?

I've seen references in various places saying that the durability of TAVI valves is still largely unknown, as they have only been used in very sick patients who usually die of other causes within five years or so. I personally would not count on one preventing a future OHS, but obviously the technology looks quite promising. There's a company that's working on a TAVI valve that would allow the exchange of valves via catheter. http://www.valvexchange.com/products/index.html

Their site is for marketing their technology of course, but I still found the discussion on the pros and cons of existing valve choices interesting - including some of the drawbacks of TAVI:
http://www.valvexchange.com/patients/index.html#patientsdilemma
Riverwear,
Here's a link for a study back in 2010 on valve in valve procedure for a failed bioprosthetic valve. I am sure there may be more recent studies.
http://circ.ahajournals.org/content/121/16/1848.short

From what I read in Lyn's reply, she was also saying that the durability of TAVI valves is still unknown as well for the same reasons you mentioned.
Her reply: "BUT He (Miller) did NOT say the TAVI Valves were NOT durable (and more specifically, the 1st generation Sapien Valve in the PARTNER A trial he was discussing) when the first set of results of the PARTNER A trials were reported in 2011, 3 years ago, he said simply because they hadn't been in patients many years (2-3? years) at that time in the PARTNER trials, altho they were in a little longer in Europe."

Very interested in read about the valve exchange!
 

river-wear

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Thanks ottagal, but that article is about a cath valve inside a standard (traditionally installed via OHS) tissue valve. I know there are people counting on that method in the not too distant future. I was wondering about serial TAVI. If it can be done, of course there will be a limit to how many because each one is necessarily smaller than the last. It's a just a theoretical question, but I've been picking at it as I consider valves.

I have also found it interesting that the FDA approval for initial TAVI procedures is for stenotic aortic valves (as far as I know), but there is no mention of the failure mode of bioprosthetic valves for TAVI valve-in-valve - implying that a torn, leaky bio valve could be a candidate.
 

Lynlw

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Sorry my back was bad yesterday and couldnt sit long. and First I want to say again, I would NOT count of a TAVI for a first valve or 1st REDO there still is not much known about longevity or durability especially in younger healthy people. Even though there have been over 60,000 TAVI implanted (as of a few months ago) and some of them in intermediate risk people, they dont know how they will do long term

Lyn, you said "...BUT since they already can place a Cath valve inside another cath valve..." I've heard of cath inside a regular tissue valve, but not two cath-placed valves. Do you have a source for that?
Sorry, some of where I heard of TAVI in TAVI was from different webcasts, but I dont remember which ones, of course there are not that many in the US since Cath valves are so new, and most still alive w/ them are doing well and also some were pulmonary since they have been in use longer and in much younger patients for the most part. I believe it is possible for 2 TAVI valves, but it depends on a lot of things, not only a larger size valve will have the best chance of fitting 2 cath valves inside than a smaller one, but even different brands of valves have better chances of having 1 or 2 valves placed inside than other brands and types of tissue valve. Some tissue valves that are in the same size Aorta and valve, have larger openings than other tissue valves. They would have the best chance of 2 IMO

but here is one study talking about it http://www.ncbi.nlm.nih.gov/pubmed/23684680 "From a total of 2,554 consecutive patients, 63 (2.47%) underwent TV-in-TV"
a few other studies mention one or 2
Also from germany,
http://link.springer.com/article/10.1007/s00392-013-0632-8
Transcatheter aortic valve replacement (TAVI), though a preferred treatment option in the elderly population carrying increased risks for open heart surgery, may result in prognosis-limiting moderate or severe aortic regurgitation. Here, we report a series of 11 patients from 3 German TAVI centers, suffering from moderate- to high-grade aortic regurgitation after CoreValve implantation, who were subsequently treated by Edwards Sapien XT implantation.
I've seen references in various places saying that the durability of TAVI valves is still largely unknown, as they have only been used in very sick patients who usually die of other causes within five years or so.
Yes, I agree and said, also the trials on younger and healthier people need to be done, to learn more about how they will do longer term or what problems show up down the road especially in 2011, but even now they hadnt done enough or had not been in long enough to know their durability

Altho since the Highest risk, was relatively low, even compared to other heart surgeries, something like chance of mortality 20% SOME of the people might not be as old and frail as some people think. Besides the reason their risk of mortality for surgery might be high for a AVR. they might be relatively healthy, especially after they have a new better working Aortic Valve. I think in the higher risk patients about half are still living 5 years later from the earliest group
Also beside the Partner and SURTAVI trials that were recently approved for intermediate risk people in the trial, not everyone ( I think less than 8% risk?) they also are following the 50,000 ish patients in Europe (I know different countries have different criteria) many who were intermeadiate risk a few years now.

But the US studies from 4, 5 years in the patients still alive the valves are doing well http://content.onlinejacc.org/article.aspx?articleid=1486723

Mild transvalvular regurgitation was present in 10.3% of patients after TAVI and 9.1%, 14.3%, 11.9%, 9.5%, and 7.1% at 1 to 5 years, respectively. Up to 4 years, no patient had prosthetic valve failure. At 5 years, 3 patients (3.4% of the total cohort) showed signs of prosthetic valve failure. One patient had moderate transvalvular regurgitation and moderate stenosis (aortic valve area 1.2 cm2; mean gradient 26 mm Hg) 5 years after implantation of a Cribier-Edwards valve. Another patient had moderate regurgitation 5 years after implantation of a Cribier-Edwards valve. The third patient had moderate stenosis (aortic valve area 1.1 cm2; mean gradient 23 mm Hg) 5 years after implantation of an Edwards SAPIEN valve. No patient developed severe stenosis or severe regurgitation.

I personally would not count on one preventing a future OHS, but obviously the technology looks quite promising. There's a company that's working on a TAVI valve that would allow the exchange of valves via catheter. http://www.valvexchange.com/products/index.html


Their site is for marketing their technology of course, but I still found the discussion on the pros and cons of existing valve choices interesting - including some of the drawbacks of TAVI:
http://www.valvexchange.com/patients/index.html#patientsdilemma
I agree, plus I think it is better to plan on an OHS REDO and be happy if you can have a TAVI, than plan on TAVI and be really disapointed if you need OHS Yes there have been a few threads about valvexchange before. it looks good, There are some very impressive doctors on their board. I hope it works, it seem pretty complicated and I could see where things might go wrong, so it will be interesting to watch. There are a few really interesting things being worked on right now, like Tissue engineered valves like cormatrix, and newer mech valves, even better anticoagulants.

They seem big fans of edwards and the perimount valves and also have pretty much used the perimount as their leaflets, since it is "based on the off-patent design ",
Also I know valve (and all medical companies) companies cherry pick the data on competitors products to make their product look better, some companies are worse at that then others
But its hard to know how truthful some of their statements on TAVI valves are when they try to scare patients from mech valves the way they describe a life w/ Coumadin
even when they bring up interesting studies like the long term on Coum I wonder how many studies showed no difference Also it looks like they havent updated the patients page since they first wrote it, since they say "Transcatheter valve are currently not approved for sale in the US. They have been cleared for use in Europe, but only on only the very sick, inoperable patient who cannot tolerate open heart surgery."

also I thought it interesting when talking about surgical tissue valves they use the word "dead" tissue alot for both pig and pericardial valves,
but when describing their valve "made from chemically preserved bovine pericardium"they never refer to it as dead tissue. They do link to studies for most things, but whenever they mention TAVI longevity, they say things like valve design and will most likely wear out in about 5 years. or Decades of research and the clinical experience with many designs of tissue valve illustrate that such transcatheter valve cannot last more than about 5 years, making it seem like it is fact, not their opinion there are no links even tho percutaneous valves (pulm and Aorta) were in use longer than 5 years, if they were failing early im sure they would show proof

It's just my opinion, but I think if a company has a product that is very good especially if they believe it is better than other choices, they should be a little more honest about the other choices, instead of making the other valves seem terrible.. But Thats marketing
 
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Lynlw

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Riverwear,
Here's a link for a study back in 2010 on valve in valve procedure for a failed bioprosthetic valve. I am sure there may be more recent studies.
http://circ.ahajournals.org/content/121/16/1848.short

From what I read in Lyn's reply, she was also saying that the durability of TAVI valves is still unknown as well for the same reasons you mentioned.
Her reply: "BUT He (Miller) did NOT say the TAVI Valves were NOT durable (and more specifically, the 1st generation Sapien Valve in the PARTNER A trial he was discussing) when the first set of results of the PARTNER A trials were reported in 2011, 3 years ago, he said simply because they hadn't been in patients many years (2-3? years) at that time in the PARTNER trials, altho they were in a little longer in Europe."

Very interested in read about the valve exchange!
Thanks. One of the things I thought was very interesting in the study you posted about percutaneous valves in older tissue valves was this
"Methods and Results— Valve-in-valve implantations were performed in 24 high-risk patients. Failed valves were aortic (n=10), mitral (n=7), pulmonary (n=6), or tricuspid (n=1) bioprostheses."
That is great for everyone, but must be especially good to hear for people with other tissue valves, since most of the studies and discussions are about cath Aortic valves and some pulmonary, so its really good to see they are also workiing on cath valves for use in Mitral and tricuspid positions.
 

ottagal

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Thanks ottagal, but that article is about a cath valve inside a standard (traditionally installed via OHS) tissue valve. I know there are people counting on that method in the not too distant future. .
I have a tissue valve and I, personally am not counting on this in the not too distant future, however, it would be nice if it did happen! :biggrin2:

I am aware that the article I posted is not a re-do TAVI study. Perhaps, it is too soon to have a TAVI/TAVR RE-do study available as it is still relatively new (I am talking about the aortic position). I don't know if this is different for pulmonary valves - OOPS...I see Lyn replied to this one in the above post.

I am sure there is a whole set of criteria of who is eligible for this procedure as well. I.e. stenotic or regurgent, original valve size, aneurysm presence, other valves involved, bicuspid or tricuspid, co-morbidies etc. I have not delved into that part so much. Perhaps, others have. -
 
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