Would Like Feedback on Both Pig & Cow Valves By Medtronic and Edwards.

[user 17111]

Hello All,

I appreciate the responses I received to my first post. Since that time I have spoken with an additional surgeon for a second opinion and that did not go well. My symptoms have gotten worse and I don't feel comfortable with the surgeon who can go in through the groin for the mitral valve replacement. .

I still don't have a surgery date, but it looks like I may go with the surgeon who wants to go in through the ribs. The valves that he is considering using are the pig by medtronic and the cow by edwards. He seems to prefer the pig valve over the cow one though.

If anyone has either of the valves could you share your experiences? Such as what were the common complications if any? How long have you had them? And how soon have you had to have them replaced? Or any other pertinent info you have to share? Are there benefits to one vs the other?

Thanks in Advance...

 

[pellicle]

Hey Becky

A worthy read...

https://academic.oup.com/ejcts/article/47/6/1075/355083

Myself I don't have a horse in this race as I've only ever had repair, some other persons and lastly a mechanical mechanical.


I felt the following was a statement I have seen some evidence to support

Having the above in mind, the decision by many surgeons to prefer pericardial valves was more emotionally based than scientifically proven,

I feel some relief you are moving away from trans-catheter

Best Wishes

 

[OldManEmu]

Becky
I have had both in the Aortic position the first was a Medtronic Mosaic porcine valve, I had this valve installed at 41 and was in for close to 7 years it was replaced at the same time as I had and aneurysm repair, the valve was still functioning OK however was showing the early signs of stenosis, the surgeon estimated that it would have needed to be replaced in another 3-4 years so was done at the time of the aneurysm repair.
The Edwards bovine valve was installed 7.5 years ago at 48 and appears to have negligible deterioration as the pressure gradient across the valve is close to what it was when installed and still below what the Medtronic valve was when brand new on its first echo.
The Medtronic Mosaic valve was relatively new to the market when I received it in 2004 so didn't have any 10 year plus human follow up, so projected service life was estimated from the lab testing procedures and sheep implants.
My understanding speaking to the cardio is that the Medtronic Mosaic hadn't provided the step change in durability indicated by testing that was estimated over the previous generation Medtronic Hancock porcine valve.
Having had both I can't say I notice any difference between them day to day, both if them are silent and I do not feel my heart beat any differently with either of them.
When It comes time for a redo I will choose another Edwards bovine valve unless there is some revolutionary technological break through in the next 5-8 years which is my realistic estimate of my valves remaining service life given my age its currently 7.5 years old.

 

[ottagal]

Hi Becky, I don't have any comparisons for you other than I had the Edwards Bovine valve installed in the aortic position, 9 years ago. Others gave you some advice. I wish you all the best in your decision. I could be wrong, but there me be a preference for one tissue type over another based on surgeon preference and patient's anatomy. Keep us posted.

 

[neil]

hi becky, Had a pigs valve for the aortic and had it 11 years no problems and going great, best decision I ever made, good luck

 

[tom in MO]

Hi Becky, At your age of 77 either tissue valve should last as long as you.. Once you are over 70 tissue valves don't deteriorate like they do for younger people. Both valves are well known and if they had any "common complications" with the valve, they wouldn't still be on the market. My surgeon would have let me choose my valve but I left it to him since he's the expert

 

[Superman]

I’m of the cynical opinion that golf and office lunches may show a correlation with surgeon preferences once you move beyond the tissue vs mechanical vs TAVR debate. There’s a reason medical device sales is a lucrative career.

 

[Superman]

Don’t take that to mean a lack of ethics. Just that once you get past FDA approval, the differences aren’t that meaningful. I don’t know that anyone can say with any degree of certainty that a cow valve will get you 15 years at 90% comfort vs 15 1/2 at 89% comfort with a pig valve. So, this wholesaler is dependable, nice to my staff, gets me what I need when I need it, “Mr or Ms Patient, I personally like the Edwards valve best for your situation.”

 

[jwinter]

Becky, I agree with all of the above. I have had the medtronics porcine and it lasted a little over 4 years (bad batch, I believe) and then decided on a mechanical as I was 60. Two years on my new one and I really like it. Very personal choice and let your surgeon help you decide.

 

[tom in MO]

Becky, I agree with all of the above. I have had the medtronics porcine and it lasted a little over 4 years (bad batch, I believe) and then decided on a mechanical as I was 60. Two years on my new one and I really like it. Very personal choice and let your surgeon help you decide.

They don't know exactly why tissue valves last longer in old people or even between two people of the same age. If your porcine valve lasted 4 years when implanted at ~55, that's one valve, not a "bad batch" unless failure was related to an actual defect. You would have found that out when took out the bad valve. Tissue valves have shorter life times and your 4 years might not be within most people's window of failure, but based upon the anecdotal stories on this forum, it could very well be in the 5-20% failure window. People under 65 need to expect their valve to fail at a time that is unpredictable by doctor or man.

For my valve, I searched the FDA's site and found out that there was one recorded failure that of course resulted in death. The leaflet became unattached. Of course I searched the website after I had the valve implanted. I went to reputable hospital and trusted my team.

 

[tom in MO]

I’m of the cynical opinion that golf and office lunches may show a correlation with surgeon preferences once you move beyond the tissue vs mechanical vs TAVR debate. There’s a reason medical device sales is a lucrative career.

When I spoke to my doctor about valve manufacturers he said that he liked St. Judes because of the proven track record. He said the other valves were different but not really markedly better. I asked him about some of the newer valves touted on this forum, and he said that he'd be happy to get one of those if I preferred, they just didn't have them on hand but could get them quickly. I wanted a valve with a low INR, and he said the St. Jude was robust and the INR range had been dropped due to experience. I was concerned about sizing and he said that they kept a stockpile of different sizes on hand because when it's an emergency operation they need the right valve, right now. If I chose a valve not stocked, he would order a variety of sized based upon the pre-surgery imaging.

Medical device sales is a lucrative career for the same reasons doctors get paid too much. It's called blackmail..."pay me a lot of money or I won't save/improve your life" I learned that from my doctor-friend's dad, who sold elevators that went into skyscrapers...He believed salesmen were more ethical than doctors and could make a good case for it at the dinner table.

 

[Superman]

When I spoke to my doctor about valve manufacturers he said that he liked St. Judes because of the proven track record. He said the other valves were different but not really markedly better. I asked him about some of the newer valves touted on this forum, and he said that he'd be happy to get one of those if I preferred, they just didn't have them on hand but could get them quickly. I wanted a valve with a low INR, and he said the St. Jude was robust and the INR range had been dropped due to experience. I was concerned about sizing and he said that they kept a stockpile of different sizes on hand because when it's an emergency operation they need the right valve, right now. If I chose a valve not stocked, he would order a variety of sized based upon the pre-surgery imaging.

Medical device sales is a lucrative career for the same reasons doctors get paid too much. It's called blackmail..."pay me a lot of money or I won't save/improve your life" I learned that from my doctor-friend's dad, who sold elevators that went into skyscrapers...He believed salesmen were more ethical than doctors and could make a good case for it at the dinner table.

Don’t disagree with anything here. Note that every indication is that your surgeon is well supported by the St Jude wholesaler. He can get other valves, but it’s more work. St Jude keeps him very well stocked and makes his job easier.

 

[pellicle]

... Just that once you get past FDA approval, the differences aren’t that meaningful.

this ^^^^^

I've been saying this same thing in different words for a long time now. Its only the marketing teams who can really talk about any differences between each valve of the same sub-category (tissue or mechanical, and note I leave TAVI right off the table).

Becky I believe that given your age whatever you pick will be fine. I hope you read the link in my first reply to your question, I believe it clarifies things well ...

Be kind to yourself and best wishes

 

[OldManEmu]

Pellicle
The reason bi leaflet mechanical valves are so similar is they are mostly designed by the same man Jack Bokros.
He was involved in the original St Jude bileaflet valve in the late 1970's.
Jack was also the founder of Carbomedics and On-X, two of the other major makers of mechanical valves.

 

[pellicle]

Pellicle
The reason bi leaflet mechanical valves are so similar is they are mostly designed by the same man Jack Bokros.
He was involved in the original St Jude bileaflet valve in the late 1970's.
Jack was also the founder of Carbomedics and On-X, two of the other major makers of mechanical valves.

very interesting bit of history ... thanks What of ATS? (also quite similar)

However do you disagree that tissue prosthetics are also essentially quite similar and that once gaining FDA approval will be pretty similar in expected life and performance?

 

[jwinter]

Becky, I am sure you will do fine with either the porcine or bovine. You asked for experiences so I shared mine. I stand corrected by Tom in that I am not positive my first valve was defective. . All I know is that in four years I could not breath easily, tests showed cardiologist that my porcine valve "appeared to be too small", and also had a loose suture on it. Fault of the valve? Probably not but it was also severely stenosed so had to replace.

My first surgery was done while I was on life support so my family had to make quick decisions. My last surgery was done at Mayo Rochester, MN. I had a very good surgeon that came highly recommended. I currently have an ON-X with INR range of 1.5 to 2.0.

I may not know all the terminology and have not studied the valves at the lengths others have here. I leave a lot of it to the cardiologists and surgeons as that is their job. Remember all information given here is just that, information on the internet. Haven't seen an actual cardiologist or surgeon post here that I know of, but then again I haven't been here as many years as others.

 

[OldManEmu]

Pellicle
Jack Bockros founded On-X around the same time as ATS was founded so wasn't involved with ATS.
The different valves that Jack designed mainly had refinements to the design with minor changes made to the opening angle of the leaflets and the hinge point of the leaflets to improve the flow around the hinge point as this is the area most at risk of clot formation.
Bovine and Porcine tissue valves have similar flow performance; correctly matched to the patient in the Aortic position the pressure gradient will be 10mmhg or less.
Bovine and Porcine tissue valves have similar durability in human trials for the duration of the trials.
The results of these trials are used by the FDA to base the approval on.
The human trials are <10 years, usually 5-8 years and a limited number of patients before approval.
The long term freedom from SVD can only be extrapolated by comparing early human trial SVD and pre-human trials results with existing approved valves.
Tissue valves seeking FDA approval are often doing so because the valve has a new fixing process applied to the tissue.
The fixing process and its effect on the tissue is the primary manufacturer controlled variable that determines the valves resistance to SVD.
With the variables of different manufactures who tend to specialise in either Bovine or Porcine using different fixing processes on two different types of tissue, long term durability >10 years is only an estimate at the time of FDA approval.
St Jude and Medtronic now have both added a bovine valve to their tissue valve range.
Edwards has only offered bovine valves as long as I have had a personal interest in the subject which is 15 years.
The only real way to determine long term durability is 20 years after being granted approval for mass market use, this often happens in Europe first with CE certification a few years before the FDA approval.
Most tissue valves are not manufactured unaltered for much longer than 20 years unlike the Medtronic-Hall tilting disk mechanical valve that was made for 37 years without update and only recently discontinued.
Medtronic now own ATS so this must have been the easy way to get a modern mechanical valve without the development process.
Early failure on both Bovine and Porcine valves for reasons other than SVD are tears, if these are going to occur they usually happen in the first two years after installation.
The most common causes of tears are a fault in the tissue that wasn't identified before the tissue was used to manufacture the valve or a fault in the manufacturing process were the tissue wasn't sewn into the stent/sewing cuff with the correct alignment causing uneven stress across the valve and early failure.

Even though the USA is the primary manufacturer of bovine pericardium heart valves QLD Australia is the major supplier of the source pericardium to Edwards.

The take away is that at the point of CE/FDA approval both Porcine and Bovine valve service life is an estimate as they haven't been tested long enough.
Meaningful data on durability is only going to start becoming available more than a decade after approval and the valve will most likely be superseded a decade or so after that, unless the manufacturer hasn't been able to develop a new product were the testing indicates improved durability.
With more existing manufactures adding bovine valves to their tissue valve range this would suggest that results of their own prototype testing is leading development in this direction.

 

[pellicle]

Hi

well hats off for a lengthy and highly detailed post (which clearly came from your memory and not researched)

if you feel inclined do PM me and we can chat about this (probably phone, cos I'm averse to typing)

Pellicle
...The different valves that Jack designed mainly had refinements to the design with minor changes made to the opening angle of the leaflets and the hinge point of the leaflets to improve the flow around the hinge point as this is the area most at risk of clot formation.

which as well as what I've read on opening and closing jet pressures is sort of where the ATS tried to differentiate itself, however (as a physicist friend of mine says) "if you're doing wind tunnel testing then all designs will converge"

so reading:

Bovine and Porcine tissue valves have similar flow performance; correctly matched to the patient in the Aortic position the pressure gradient will be 10mmhg or less.

and

Bovine and Porcine tissue valves have similar durability in human trials for the duration of the trials.

suggests that you'd agree that there isn't "streets of difference between them"

The long term freedom from SVD can only be extrapolated by comparing early human trial SVD and pre-human trials results with existing approved valves.

totally, and a point I often phrase as "we won't know how well the makers claims for improvement stack up until we've got long term actual data"

Tissue valves seeking FDA approval are often doing so because the valve has a new fixing process applied to the tissue.

which will remain "unknown" in its actual efficacy until we have long term results in vivo

Medtronic now own ATS so this must have been the easy way to get a modern mechanical valve without the development process.

yes, I read of this acquisition ....

its always good to hear from you

 

[epstns]

So. . . how long do I have to run my valve before I know how long it will last? Ummm. . . any single valve will last until it fails, and no longer. All we have of any value so far, is the actual freedom from explant data that the manufacturers have collected on their valves. None of it qualifies as an RCT, but we can make informed decisions based upon the documented experiences of other patients who have that same valve. For newly released designs, we won't know until these, too, mature.

I have run into the same quandary when researching cancer treatments. I chose a relatively new form of radiation. Some criticized me for choosing a mode that had "only" 9 years of documented results. My response was something like "If I only choose treatments having 20 or more years of documented results, I will only be choosing from obsolete treatment modes."

 

[Superman]

I have run into the same quandary when researching cancer treatments. I chose a relatively new form of radiation. Some criticized me for choosing a mode that had "only" 9 years of documented results. My response was something like "If I only choose treatments having 20 or more years of documented results, I will only be choosing from obsolete treatment modes."

Probably best to take a wait and see approach then.

*Apologies for the morbid sense of humor