TAVR/TAVI: Recall of SAPIEN 3 Ultra Delivery System Due to Burst Balloons During Surgery

[nobog]

I wouldn't worry to much as to what valve you get - they are all "OK". What's equally important is the delivery system (which gets no press) and the person running it (your doctor).

 

[rich01]

@Ladybug

I'll be waiting for your report on how it goes. I'm having TAVR using the Medtronics valve on Sept 23.

 

[hx77]

Mid 50's ? mechanical. (my opinion)

My intention is to have at most one OHS in my life. A mechanical valve is a potential solution but it's not definite as if it fails, another OHS is needed to replace it. On the other hand, a bioprosthetic valve allows me to take advantages of technology advancement in the field.

 

[tom in MO]

My intention is to have at most one OHS in my life. A mechanical valve is a potential solution but it's not definite as if it fails, another OHS is needed to replace it. On the other hand, a bioprosthetic valve allows me to take advantages of technology advancement in the field.

If you want a single OHS and are under 60, mechanical is still the way to go. From the little I've read just having a bioprosthetic valve doesn't mean a person is a candidate for TAVR when it's time for replacement...stuff happens.

 

[pellicle]

@hx77
I second this

If you want a single OHS and are under 60, mechanical is still the way to go. From the little I've read just having a bioprosthetic valve doesn't mean a person is a candidate for TAVR when it's time for replacement...stuff happens.

sure you will also get the possibilities of complexity of management of INR and compounding influences of other drugs, but this will most likely represent less difficulty than all the follow up sessions with your cardio as the tissue valve inevitably collapses (because Structural Valve Degradation is not linear and so will be monitored more closely as it comes).

Then you have the issues surrounding the valve replacement. If you are luck it goes though no problems.

Some alternative views to ponder, think of questions to ask and ask them until you are satisfied.

 

[Duffey]

@hx77

. . . but this will most likely represent less difficulty than all the follow up sessions with your cardio as the tissue valve inevitably collapses (because Structural Valve Degradation is not linear and so will be monitored more closely as it comes).

I have had far fewer sessions with my cardiologist post valve replacement than before, and it has been 14 years since I received a bovine valve. Last December she said that she would see me in two years. I think if you asked other tissue valve recipients how often they visit their cardiologist, no matter how long since implantation, they would say it’s no more and possibly less than those with mechanical valves.

 

[Suckyvalvegurl]

I have only had my bovine since February, but it is fine and I am really glad. I am 56. I had minimally invasive surgery so no cracking the breast bone. I just do not understand why this is not more readily available to people.

 

[Paleowoman]

From the little I've read just having a bioprosthetic valve doesn't mean a person is a candidate for TAVR when it's time for replacement...stuff happens.

I had AVR with bioprosthetic/bovine valve five and a half years ago and have moderate patient prosthesis mismatch which will probably mean a re-do sooner rather than later as the pressure gradients are very high. I would not be a candidate for TAVR, even if I wanted one which I wouldn't, as my bioprosthetic valve is only 19mm which is too small for TAVR which can only be implanted in a larger valve: 23mm and above I believe.

If I'd had my AVR just two years later I would have been able to have the new Inspiris Resilia valve which is designed to last much longer than the previous generation of bioprosthetic valves - shame I just missed out on that. It is also being implanted in patients younger than 60 years as written about on forum several times.

I have had far fewer sessions with my cardiologist post valve replacement than before, and it has been 14 years since I received a bovine valve. Last December she said that she would see me in two years. I think if you asked other tissue valve recipients how often they visit their cardiologist, no matter how long since implantation, they would say it’s no more and possibly less than those with mechanical valves.

I've seen my cardiologist tons more since AVR than prior to AVR, now see him every six to twelve months. And tons more echocardiograms too. But then things didn't go right and usually they do so I expect you're right Duffey.

 

[nobog]

I think if you asked other tissue valve recipients how often they visit their cardiologist, no matter how long since implantation, they would say it’s no more and possibly less than those with mechanical valves.

A visit to your cardiologist and tissue valve degradation is two different things. I have personally seen a tissue valve last 6 months and I have personally seen a tissue valve 20 years, however, "they" like to sprout the average - which indeed may be 10 -15 years - or whatever, but what you need to do is to Goggle the words "standard deviation". There is a population spread to everything and this is the scientific way of explaining it - and tissue valves are no exception, you are just rolling the dice hoping you don't get the -2 or -3 std dev valves of the population.

Mechanical valves have no standard deviation as far as wear-out is concerned (you die before the valve wears out) - of course other things can happen - think improper INR items.

 

[Duffey]

A visit to your cardiologist and tissue valve degradation is two different things. I have personally seen a tissue valve last 6 months and I have personally seen a tissue valve 20 years, however, "they" like to sprout the average - which indeed may be 10 -15 years - or whatever, but what you need to do is to Goggle the words "standard deviation". There is a population spread to everything and this is the scientific way of explaining it - and tissue valves are no exception, you are just rolling the dice hoping you don't get the -2 or -3 std dev valves of the population.

Mechanical valves have no standard deviation as far as wear-out is concerned (you die before the valve wears out) - of course other things can happen - think improper INR items.

Yes, I am aware of the difference. However I do not think that it is inevitable that a tissue valve will require many more sessions with the cardiologist, as Pellicle stated, as the valve wears out.

 

[Duffey]

I had AVR with bioprosthetic/bovine valve five and a half years ago and have moderate patient prosthesis mismatch which will probably mean a re-do sooner rather than later as the pressure gradients are very high. I would not be a candidate for TAVR, even if I wanted one which I wouldn't, as my bioprosthetic valve is only 19mm which is too small for TAVR which can only be implanted in a larger valve: 23mm and above I believe.

If I'd had my AVR just two years later I would have been able to have the new Inspiris Resilia valve which is designed to last much longer than the previous generation of bioprosthetic valves - shame I just missed out on that. It is also being implanted in patients younger than 60 years as written about on forum several times.


I've seen my cardiologist tons more since AVR than prior to AVR, now see him every six to twelve months. And tons more echocardiograms too. But then things didn't go right and usually they do so I expect you're right Duffey.

Is it safe to say that if you had similar valve sizing issues with a mechanical valve, that you would also incur more testing and cardio visits?

 

[LoveMyBraveHeart]

If I'd had my AVR just two years later I would have been able to have the new Inspiris Resilia valve which is designed to last much longer than the previous generation of bioprosthetic valves - shame I just missed out on that. It is also being implanted in patients younger than 60 years as written about on forum several times.

Mathias got the Inspiris Resilia implanted last December...it's already been replaced with an On-x mech. due to patient prosthesis mismatch, but also upon inspection during surgery, the valve was falling apart...it had small holes in each of the leaflets like it was already starting to break down. Had only been implanted for 8 months at the time. His surgeon took pictures to share with us

From my understanding, the Inspiris Resilia is mentioned to have a longer lifespan than its predecessors because of the storage method. It is "dry stored" as opposed to storing in a preserving liquid (formaldehyde, I think?) which in theory, is supposed to protect the prosthetic against stenosis for a longer period of time. Unsure if there are studies that support this. Mathias' surgeons didn't know of any evidence supporting this acclimation, that at the time it was only theoretical.

As for the cardio, we have been frequent flyers as Mathias is kind of a funky case and his cardio is very thorough and likes to check in often. Hoping now that the valve has been re-replaced and after we get through all of the typical follow up, we wont have to see her quite as often, though we do love her!

 

[Paleowoman]

Is it safe to say that if you had similar valve sizing issues with a mechanical valve, that you would also incur more testing and cardio visits?

I would guess so as patient prosthesis mismatch leads to high pressure gradients which has an effect on the heart ultimately. But I suspect that a mechnical valve wouldn't degrade under the higher pressure gradients, would it ? It would just effect the heart and the person. The effect of PPM on me is that I am not as fit as I was prior to surgery.

 

[Paleowoman]

From my understanding, the Inspiris Resilia is mentioned to have a longer lifespan than its predecessors because of the storage method. It is "dry stored" as opposed to storing in a preserving liquid (formaldehyde, I think?) which in theory, is supposed to protect the prosthetic against stenosis for a longer period of time.

Hi @LoveMyBraveHeart There are two things that are supposed to protect the Inspiris Resilia valve from calcification/stenosis:
"1. Blocks Calcium Build-up. The INSPIRIS valve uses the RESILIA tissue, a new type of bovine (cow) tissue with special technology that blocks calcium build-up on the valve." (A friend who got one told me it's a bit like a teflon coating)
"Reducing calcium build-up is important because calcium build-up is the main cause of tissue valve failure. The new RESILIA tissue has demonstrated significantly less calcium build-up in animal studies.*"
"2. Dry Storage. Most tissue valves are stored in aldehyde liquid which attracts calcium. Thanks to the unique RESILIA tissue, the INSPIRIS valve can be stored dry thereby preventing further exposure to the aldehydes."
From this article: https://www.heart-valve-surgery.com/heart-surgery-blog/2018/08/09/inspiris-resilia-fda-approval/

 

[Agian]

I have an On-X. Yes, it ticks. But it doesn't bother me. Warfarin? Meh. Easy Peasy.

I have thought about the ticking though. For a fella it would be like a novelty. I wonder what it would do for a young woman's self esteem though. A young girl might be more self conscious about it than a fat old git like me.

We had a lady here recently who said she wanted to find a partner who could understand. I also met a guy in cardiac rehab who seemed depressed and said he was waiting for it to stop! I reckon he would have been depressed anyway.

Check out CT Fletcher talking about it on YouTube.

 

[LoveMyBraveHeart]

There are two things that are supposed to protect the Inspiris Resilia valve from calcification/stenosis:
"1. Blocks Calcium Build-up. The INSPIRIS valve uses the RESILIA tissue, a new type of bovine (cow) tissue with special technology that blocks calcium build-up on the valve." (A friend who got one told me it's a bit like a teflon coating)
"Reducing calcium build-up is important because calcium build-up is the main cause of tissue valve failure. The new RESILIA tissue has demonstrated significantly less calcium build-up in animal studies.*"
"2. Dry Storage. Most tissue valves are stored in aldehyde liquid which attracts calcium. Thanks to the unique RESILIA tissue, the INSPIRIS valve can be stored dry thereby preventing further exposure to the aldehydes."
From this article: https://www.heart-valve-surgery.com/heart-surgery-blog/2018/08/09/inspiris-resilia-fda-approval/

Cool, thanks for the info. I am hoping the findings in the studies of animals with the valve will carry over and that human recipients can have more longevity out of the valve than Mathias did. I guess his just wasn't meant to be in his body. Hoping this On-X will be the solution!

 

[Duffey]

I would guess so as patient prosthesis mismatch leads to high pressure gradients which has an effect on the heart ultimately. But I suspect that a mechnical valve wouldn't degrade under the higher pressure gradients, would it ? It would just effect the heart and the person. The effect of PPM on me is that I am not as fit as I was prior to surgery.

No, a mechanical wouldn’t.

Mathias got the Inspiris Resilia implanted last December...it's already been replaced with an On-x mech. due to patient prosthesis mismatch, but also upon inspection during surgery, the valve was falling apart...it had small holes in each of the leaflets like it was already starting to break down. Had only been implanted for 8 months at the time. His surgeon took pictures to share with us

From my understanding, the Inspiris Resilia is mentioned to have a longer lifespan than its predecessors because of the storage method. It is "dry stored" as opposed to storing in a preserving liquid (formaldehyde, I think?) which in theory, is supposed to protect the prosthetic against stenosis for a longer period of time. Unsure if there are studies that support this. Mathias' surgeons didn't know of any evidence supporting this acclimation, that at the time it was only theoretical.

As for the cardio, we have been frequent flyers as Mathias is kind of a funky case and his cardio is very thorough and likes to check in often. Hoping now that the valve has been re-replaced and after we get through all of the typical follow up, we wont have to see her quite as often, though we do love her!

I thought Mathias originally received a porcine valve at CC? At least that’s what was said in your first post.

 

[nobog]

But I suspect that a mechnical valve wouldn't degrade under the higher pressure gradients, would it ?

That is correct.

 

[Paleowoman]

Hi @LoveMyBraveHeart Sorry to read Mathias's valve deteriorated so soon after it was implanted. I see you wrote he had patient prosthesis mismatch - do you know how bad that was, ie moderate or severe, and what were his pressure gradients ? I guess they worked out he had PPM because of what showed on a post surgery echocardiogram ?

 

[LoveMyBraveHeart]

I thought Mathias originally received a porcine valve at CC? At least that’s what was said in your first post.

You're correct, I misspoke. He received the Inspiris Resilia, so bovine. By the time I saw my mistake, I was out of the editing window.