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

[LoveMyBraveHeart]

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 ?

It was severe. I'm unsure of pressure gradients, but to put it in perspective his Inspiris was 23mm, and his On-X is a 27/29. His surgeon here was able to place a suction tube between his native tissue and the valve ring easily. The leak was destroying his RBCs and causing the symptoms that he had before his surgery, only worse. Kind of scary when I think too much about it.

 

[Paleowoman]

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

That is correct.

But the heart would get damaged with left ventricular hypertrophy as when a valve is too small (patient prosthesis mismatch) it is effectively stenotic even though it's functioning fine - ie my pressure gradients are nearly in the severe stenotic range but my valve has not degraded yet.

 

[Agian]

It was severe. I'm unsure of pressure gradients, but to put it in perspective his Inspiris was 23mm, and his On-X is a 27/29.

That's the one I've got. They usually reserve the 27/29 for royalty.

 

[Duffey]

You're correct, I misspoke. He received the Inspiris Resilia, so bovine.

Thanks for the clarification. Anytime a forum member suffers a valve replacement failure, I think most of us pay close attention to the possible causes along with the valve type.

 

[LoveMyBraveHeart]

That's the one I've got. They usually reserve the 27/29 for royalty.

Good to hear. The surgeon made me chuckle when he said the size he put in, so we should be satisfied with it's performance. Like it's the latest and greatest car part.

 

[Paleowoman]

It was severe. I'm unsure of pressure gradients, but to put it in perspective his Inspiris was 23mm, and his On-X is a 27/29. His surgeon here was able to place a suction tube between his native tissue and the valve ring easily. The leak was destroying his RBCs and causing the symptoms that he had before his surgery, only worse. Kind of scary when I think too much about it.

Have they investigated why the original surgeon put in a valve too small? That's an incredible difference from 23mm to 27/29 ! My valve is too small for my body but the right size for the space where the aortic valve goes in my heart....my heart size is actually too small as I have a depressed sternum...it's an anatomical problem. I can only get a bigger valve by having an arotic root enlargement or a valve placed supra-annually.

 

[Duffey]

It was severe. I'm unsure of pressure gradients, but to put it in perspective his Inspiris was 23mm, and his On-X is a 27/29. His surgeon here was able to place a suction tube between his native tissue and the valve ring easily. The leak was destroying his RBCs and causing the symptoms that he had before his surgery, only worse. Kind of scary when I think too much about it.

I still think someone messed up at Cleveland, and yes, I know you disagree!

 

[LoveMyBraveHeart]

I still think someone messed up at Cleveland, and yes, I know you disagree!

We aren't sure what happened. Since being reopened, his surgeon was able to find more information than could be discovered via imaging. His surgeon here is in contact with Cleveland to see what the issue could have been. We have a follow up on Sept 5th, so will see what he has to say then.

 

[Paleowoman]

When aortic vlave replacement is done, the surgeon uses a 'sizer' to measure the space where the valve is placed which is where the native valve has just been taken from. The space has very fibrous tissue (this explained to me by a cardiac surgeon) so the sizer will measure the exact space. There's no way a valve so small can be implanted except in error ! I agree with Duffey that someone must have messed up.

 

[LoveMyBraveHeart]

Thank you for your input. I understand many people think this was an error, and perhaps it was. What I don't like to do is dwell on something that I can't change. It has been fixed now, his previous surgeon has his perioperative notes from this last surgery and that's all that matters. I wont spend time placing blame, nor thinking about the what if's. That kind of negativity is not something I can mentally handle right now. Thank you again for bestowing your wealth of knowledge. I do like to learn as much as I can and who better to learn from than veterans of the same surgery!

 

[Paleowoman]

I know it can be distressing to think that a surgeon has made a mistake, especially in such major surgery. I would think that at the very least Edwards would be wanting to do an investigation as to why one of their valves degenerated ("small holes in each of the leaflets” you wrote) after just a few months. Edwards were very interested in my valve even though it has not degenerated - in fact they probably were interested just in case mine did degenerate early. If one of their valves had a manufacturing fault they would want to know, that’s why each valve has it’s own serial number so it can be traced back to when it was manufactured, or, on the other hand, if one of their valves was damaged during surgery they’d want to know that.

 

[Duffey]

Thank you for your input. I understand many people think this was an error, and perhaps it was. What I don't like to do is dwell on something that I can't change. It has been fixed now, his previous surgeon has his perioperative notes from this last surgery and that's all that matters. I wont spend time placing blame, nor thinking about the what if's. That kind of negativity is not something I can mentally handle right now. Thank you again for bestowing your wealth of knowledge. I do like to learn as much as I can and who better to learn from than veterans of the same surgery!

Your feelings are quite understandable. My interest is selfish; I will have to make decisions at some point in the future about what valve type, where I have it done, and possibly how it is implanted. The reason why a member’s valve failed are part of my consideration. I am very happy that Mathias won’t have to worry about the same.

 

[LoveMyBraveHeart]

I know it can be distressing to think that a surgeon has made a mistake, especially in such major surgery. I would think that at the very least Edwards would be wanting to do an investigation as to why one of their valves degenerated ("small holes in each of the leaflets” you wrote) after just a few months. Edwards were very interested in my valve even though it has not degenerated - in fact they probably were interested just in case mine did degenerate early. If one of their valves had a manufacturing fault they would want to know, that’s why each valve has it’s own serial number so it can be traced back to when it was manufactured, or, on the other hand, if one of their valves was damaged during surgery they’d want to know that.

I believe his surgeon is sending his findings into the manufacturer as well. The photos were interesting to see, I think he took them specifically so he could send them to Edwards (and the original surgical team). Maybe we will get some answers...maybe we wont. We'll see. All I care about is that we were diligent about follow tests after the December surgery and caught the fault so it could be fixed in a relatively timely manner. Hopefully the last fix, too.

 

[LoveMyBraveHeart]

Your feelings are quite understandable. My interest is selfish; I will have to make decisions at some point in the future about what valve type, where I have it done, and possibly how it is implanted. The reason why a member’s valve failed are part of my consideration. I am very happy that Mathias won’t have to worry about the same.

Thank you. I'm sure with your detailed research, you will find the best solution for your situation. And probably be able to tell the Dr. why and how to do the whole procedure! That's how I feel sometimes when I'm arguing medication changes and side effects.

 

[pellicle]

Hi

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.

but (importantly) your valve is not in SVD yet ... right? Recalling that I wrote: "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)."

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 would agree ... except for the clause "no matter how long since implantation". While things are running nicely yes, but SVD will occur eventually unless you die first. I would be surprised if you got 30 years from that valve. Fish through threads here and see the ones where they write "my tissue valve is failing / approaching time to change" ... then the monitoring ramps up.

SVD is inevitable for any tissue prosthetic of sufficient duration, its actually the ONLY thing that mechanical does not really suffer from and thus if you are sufficiently young its the only factor that gives it a stand out advantage. Which is why I always say for people in their 60's at OHS that its not really a signficant difference which you choose. In their 40's that equation changes.

I don't wish to ask a lady her name but if you apply that above to yourself (no need to tell me the answers) you'll see that I may not be referring to your actual case situation

 

[Duffey]

So for clarification, how many extra cardiologist visits do you think are required from the time the tissue valve degradation is recognized until new replacement? I have been told that once the valve starts to fail, it goes fairly quickly so there’s not a great deal of time passage for an onslaught of appointments.

 

[Protimenow]

I'm guessing that there may not be an 'onslaught of appointments' if it's starting to fail, and you're told that it's only got a year or so? (I'm only guessing). At that time, you may want to decide whether it's worthwhile to replace it sooner, rather than later, or to wait until it gets worse (possibly damaging your heart) and then replace or repair(?) it.

I was in my early 40s when I got my mechanical - at that time, they probably didn't think about more than 7 or 8 years on a tissue valve, so the choice of a mechanical was a no brainer.

So - how many appointments you have to put up with when your valve starts to fail may depend on how long you want to wait to replace it --- never an easy calculation.

 

[Ladybug]

@Ladybug

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

Are you nervous? I am. It’s the fact of how in dealing with the hospital, their left hand doesn’t have a clue what the right hand is doing. And, I’m sweating bullets over what my new normal might be.

 

[rich01]

Are you nervous? I am. It’s the fact of how in dealing with the hospital, their left hand doesn’t have a clue what the right hand is doing. And, I’m sweating bullets over what my new normal might be.

I'm having stents on Sept 9 and I figure the cardiac cath I had last January is good prep for the stents. Then the stents will be good prep for TAVR. I am trying to stay real busy so I don't have time to think about it. I imagine a day or 2 before stent procedure, I will start getting a little anxious. If stents go as well as expected, I don't think I will be overly worried about TAVR.

When I found out a year ago my aortic stenosis had progressed to severe, my efforts have been focused on finding a way to have TAVR and not SAVR. If I was having SAVR I wouldn't be handling it very well. I was scheduled to have TAVR through the Medtronics TAVR trial, but when FDA approved TAVR I was switched to Medicare, but same interventional cardiologist, same valve, same hospital, same date.

I did my research early on, so now I have put my faith in the hands of my cardiologist. My job is to show up and be a good patient, his job is to perform at an expert level.

 

[Protimenow]

The cardiac cath was probably an excellent prep for your stent procedure. Instead of just looking at your coronary arteries, they'll also insert a stent (or two?).

This should be the same thing for the TAVR. (And you already know all of this already, so I'm just repeating myself again)