Medtronic failure rates

[tobagotwo]

Please note that it would be inaccurate to use the postings in this forum as a gauge of valve success or failure. The tissue valve people you will see still here are more likely to be those who have experienced an issue.

As far as the valves' histories, I am certain I published some dates long ago, but I just can't seem to coax them out with a search. However, here is what I could find today:

The Medtronic Mosaic porcine bioprosthesis was approved by the US FDA in 2000. It uses the same stent that was used by the Hancock valves that were already approved, but is otherwise largely dissimilar. The earliest reference I have yet found to pre-approval (clinical trial) implants was from February, 1994. Medtronic has been providing US-approved tissue valves for over 30 years, but not the Mosaic or a direct-line predecessor.

The first Edwards Perimount bovine valve was implanted in 1981, and the Perimount Magna was approved in 2004 (I don't have a date for the base Perimount approval). The Mitral version of the Magna was approved and released in 2008. An even newer version of the aortic Perimount Magna was approved in 2009 for easier implantation in minimally-invasive surgeries. According to their 20-year study: The data indicate that patients 60 years and older who receive a Carpentier-Edwards PERIMOUNT aortic valve will have a greater than 90% chance of not needing a new valve for 20 years. (250 patients)

St. Jude's Biocor was approved in the US in 2005. In its original form, it was first implanted in 1983. In Patients 65 and older, their 20year data study found that the Biocor valve's rate of freedom from reoperation for structural valve deterioration was 86.5 percent. (about 1,950 patients)

http://www.springerlink.com/content/n07164861h212l52/

Bioprostheses have become the predominant diseased aortic valve substitute for aortic valve replacement. The experience of the Society of Thoracic Surgeons was published in 2009 by Brown and colleagues [1] documenting that the use of bioprostheses increased from 42% in 1996 to 78.4% in 2006. The mechanical prostheses use declined to 20.5%. The use of bioprostheses for aortic valve replacement has increased in Western Europe but not to the same extent.

Wouldn't you love to know what the other 1.1% got?

Best wishes,

 

[Luana]

This was originally posted under Valve Selection - Tissue vs. Mechanical - terrified and confused
From Jendyk: "I am taking the 17 year warrantee on my bovine valve as gospel. My surgeon says that he knows of cases where the bovine valve has lasted 30 years and is going strong."

We know from a few posts by Al that the bovine valve has been in use for about 20 years.

So how is it that surgeons know of people who've had them for 30 years, and/or other surgeons saying it's likely they can last 30 years? This is anecdotal evidence and not fact.

Point here is not tissue vs. mechanical, which one is better; the point is, when making the choice, one needs to know about how long a tissue valve may or may not last based on facts not on anecdotal evidence.

 

[Lynlw]

This was originally posted under Valve Selection - Tissue vs. Mechanical - terrified and confused
From Jendyk: "I am taking the 17 year warrantee on my bovine valve as gospel. My surgeon says that he knows of cases where the bovine valve has lasted 30 years and is going strong."

We know from a few posts by Al that the bovine valve has been in use for about 20 years.

So how is it that surgeons know of people who've had them for 30 years, and/or other surgeons saying it's likely they can last 30 years? This is anecdotal evidence and not fact.

Point here is not tissue vs. mechanical, which one is better; the point is, when making the choice, one needs to know about how long a tissue valve may or may not last based on facts not on anecdotal evidence.

Al may posted the bovine has been around 20 years, but it has been longer. The 2nd generation were used(In the US) in 1981..(links are above and they have been posted here before) that is 29 years.
My point about wonderring about how many people could possibly have a tissue valve valve 30 years, is one should also know that there isn't Data for the mechanical valves IN USE NOW being used in people longer than 30 years. Just as there are not many people who have had their tissue valve 25-30 years, the same is true for mechanical valves. People say they should last a lifetime, but there is not Data to prove they will last 30 years in a person, let alone more. St Jude has the longest according to Al they first were MADE in 77, (I don't know when it was first used in the US, the st Jude site says 25 years)
Carbontics and ATS have been being made about 25 (not sure when they were first used) and ON-X 15

 

[Nancy]

Joe died in 2006, and he had his original Bjork-Shiley aortic valve which was implanted in 1977, and it was working perfectly until his last moment on earth. That's 29 years. BTW, there were mechanical valves prior to St. Jude, Bjork-Shiley for one, but there were others even before that one. I know that pig valves were available when Joe had his first surgery, not sure about bovine valves though. Cadaver valves were probably available then too, but not sure.

And I am not sure how much data is available for those early years.

There are others who have had mechanical valves older than Joe's. I think Joann of member name "John & Joann" has a mechanical valve/s from much earlier.

 

[Luana]

Al may posted the bovine has been around 20 years, but it has been longer. The 2nd generation were used(In the US) in 1981..(links are above and they have been posted here before) that is 29 years.
My point about wonderring about how many people could possibly have a tissue valve valve 30 years, is one should also know that there isn't Data for the mechanical valves IN USE NOW being used in people longer than 30 years. Just as there are not many people who have had their tissue valve 25-30 years, the same is true for mechanical valves. People say they should last a lifetime, but there is not Data to prove they will last 30 years in a person, let alone more. St Jude has the longest according to Al they first were used in 77, (I don't know if that was in the US, the st Jude site says 25 years)
Carbontics and ATS have been being made about 25 (not sure when they were first used) and ON-X 15

Ok, so this is what we do know:
1) Bovine valves have been in use for about 30 years.
2) Mechanical valves lasting a lifetime is anecdotal evidence rather than fact.
3) How long a tissue or mechanical valve will last is not really known.

Can we say the above 3 statement are facts?

Is there data showing mechanical valve failure, where anyone has had to have a mechanical valve replaced because it was no longer functioning right, and not do to prosthesis mismatch, or recall by manufacturer?

I think it would be good if we could, even if there are only a few, get some facts in order.

 

[ALCapshaw2]

Ok, so this is what we do know:
1) Bovine valves have been in use for about 30 years.
2) Mechanical valves lasting a lifetime is anecdotal evidence rather than fact.
3) How long a tissue or mechanical valve will last is not really known.

Can we say the above 3 statement are facts?

Is there data showing mechanical valve failure, where anyone has had to have a mechanical valve replaced because it was no longer functioning right, and not do to prosthesis mismatch, or recall by manufacturer?

I think it would be good if we could, even if there are only a few, get some facts in order.

Luana -

I agree with your point #3 that no one knows for sure how long a particular valve will last in their body.

FYI, Mechanical Valves have been mechanically tested (at higher than normal heart rates) in laboratory tests to demonstrate that they will function for several human lifetimes based on the number of cycles of operation. How long they last in a particular patient is a separate issue. The Leading Reason for Mechanical Valve Explant (removal) is Pannus Tissue Growth which is entirely a function of the particular patient. Pannus Tissue Growth can impede proper operation of Both Mechanical and Tissue Valves. The ONLY valve that has a built-in Barrier to retard / prevent Pannus Tissue from impinging the valve leaflets are the Mechanical Valves made by On-X.

We also had a member who chose to have her (St. Jude) Mechanical Valve removed because she had had repeated Brain Bleeds and her Doctors were conserned about the risk of hemoralgic(sp?) stroke. (Anti-Coagulation management / mis-management may have been a complicating factor).

ALL Valves go through a development cycle that includes authorized Trials before they receive FDA accreditation for use in the USA. I remember reading a post to VR several years ago by a member who reported having to sign a release to receive a St. Jude Bi-Leaflet Mechanical Valve before it had FDA approval (as opposed to a Ball and Cage Valve which was her only other mechanical valve option at the time). I expect there are similar stories for the Tissue Valves. I would expect the number of pre-FDA approved valves would be rather low (hundreds?) for both mechanical and tissue valves. Just because a valve has been in use for 30 years does not mean that *any single valve* has been in use for that period of time. Unmodified Porcine Tissue Valves (straight from the pig) have probably been in use for 30 years or more, but I would be surprised if ANY of them are still functioning. Most unmodified porcine tissue valves had a history of failing in 8 to 12 years, even in older patients. Humorist / columnist Lewis Grizzard did not survive his last porcine valve replacement (#3 or #4, I forget which).

I'm thinking that member Gina (a.k.a. geebee) has had her St. Jude Mechanical Valve for 30 years.
EDIT - I see that Joanne (of John & Joanne) received a Double Valve Replacement in 1971 at the Cleveland Clinic.
That was before the BiLeaflet Valves were in production so I *assume* she received Ball and Cage Valves.

I found a reference stating:
Carpentier-Edwards PERMIOUNT Pericardial Bioprosthesis 20 Year Results.
Data on file at Edwards Lifesciences 2003.

This would suggest that the study was initiated in 1983.
It is my understanding that most of those (early) recipients were over age 60.

To suggest that Tissue Valves might last as long as Mechanical Valves would be a Highly Inaccurate and Misleading portrayal of the facts, especially for patients under age 60. I'm sure that the Valve Manufacturers have historical data on their valve performance (and the performance of their competitors) but it hasn't 'jumped out at me' from quick Google Searches.

From posts on VR.org, we know that Early Failures of Tissue Valves are not uncommon.
I do not recall reading of any Early Failures of mechanical valves except in cases of Bacterial Endocarditis which would require replacement of any valve. EDIT - OOPS! I forgot about the St. Jude Silzone Mechanical Valves. Do a Google Search for "Silzone" to find the history of those valves.

I agree that Every Valve has it's positive and negative attributes.
Most patients (who actually choose) eventually arrive at a decision on which best fits their needs and lifestyle.
I'm guessing that most select the option whose negative aspects they believe they can best live with.
And Yes, those choices are Highly Individual.

'AL Capshaw'

 

[Nancy]

There was a recall of Bjork-Shiley mechanicals. The strut welds were poorly executed and were breaking, causing death for some. Other people had to have an explant and redo. Joe had to have his examined, but his model was not involved, although it gave us some pretty scary moments. He never had to have a redo on that valve.

Then there was the St. Jude Silzone mechanical recall which caused paravalvular leaks, some explants, and some deaths. Not every Silzone caused this problem, but we did have a member here from Ireland, whose wife died as a result of this problem, and many others around the world who died as a result of this problem. I also think we have a few members here who have not had problems with the Silzone and may still have theirs in place.

Those are the mechanical ones that I remember. There may be others.

As far as tissue valves, the Cryolife Synergraft valve had major problems. This valve (Cryolife Synergraft) is a decellularized homograft heart valve. Here are some posts about its recall.

http://www.valvereplacement.org/for...pplier-of-Implant-Tissue&highlight=synergraft

There again, we have some older members who had to have an explant and redo, some who did not do well with the redo, and also a couple of deaths. I also think there are members here who still might have this valve in place.

And other heart appliances have had recalls, some pacemakers, and some defibrillators. Some had defective leads, others allowed infection to fester inside the appliance causing endocarditis because they were not sealed properly, and other various problems.

 

[Lynlw]

Ok, so this is what we do know:
1) Bovine valves have been in use for about 30 years.
2) Mechanical valves lasting a lifetime is anecdotal evidence rather than fact.
3) How long a tissue or mechanical valve will last is not really known.

Can we say the above 3 statement are facts?

Is there data showing mechanical valve failure, where anyone has had to have a mechanical valve replaced because it was no longer functioning right, and not do to prosthesis mismatch, or recall by manufacturer?

I think it would be good if we could, even if there are only a few, get some facts in order.

Pretty much. and Just to clarify, I did NOT say tissue and mechanical valves would last the same time in anyone, just that there is NOT proof the mechanical valves used to day have lasted 30 years in patients, simple because they haven't been around long enough.

but for #1 the bovine valves used in 81 are the 2nd generation Perimount valve that are still in use
Other bovine valves were used earlier. but for the most part people are talking about the Perimount when discussing long lasting bovine valves.It will be a while to see the average length for any of the valves until the first few groups of patients that recieve any new valve, either need to have that valve replaced or out live it. Since the last studies I've read for the perimount and st jude, still had patients with their valve,we'll have to wait. One problem is out of the first groups in any of the valve replacements the number of patients still alive is getting pretty low.

Usually when a mechanical valve needs replaced, it is because of BE, or tissue growing blocking it or clots ect . I don't know of any data, most of the different studies give breakdowns of how many of the patients needed there valve replaced, had bleeds or thrombosis or valve replaced mortality or morbidity. ect. but I don't know of one place that has all the info.


Also since Al mentioned them by name "I'm thinking that member Gina (a.k.a. geebee) has had her St. Jude Mechanical Valve for 30 years.
EDIT - I see that Joanne (of John & Joanne) received a Double Valve Replacement in 1971 at the Cleveland Clinic.
That was before the BiLeaflet Valves were in production so I *assume* she received Ball and Cage Valves."

Joanne did have a Double valve replacement in 77, but according to her signature she also had a double valve in 99, I do not know for a fact, but guessing they replaced the earlier valves
Double Valve Replacement, 1971, Cleveland Clinic
Pacemaker-1996, 2003
Double Valve Replacement, Bovine Patch, 3 Bypass-Cleveland Clinic, 1999

And Geebee's had her 1st valve replaced about 15 years later according to her thread when her 2nd valve reached 15. I know she had a 3rd surgery, which I *believe* was to clean up tissue around her 2nd valve instead of replacing it.
http://www.valvereplacement.org/forums/showthread.php?30559-My-St.-Jude-is-15!&highlight
"Although it has been almost 29 years since my first MVR, today marks the 15th valversary of my St. Jude implant. I find it so very hard to believe either of these timeframes. It just seems impossible that so much time has passed"

 

[ALCapshaw2]

I called Carpentier-Edwards and spoke with a Customer Service Representative.
He did not know how long the Bovine Pericardial Tissue Valves have been in service
or the length of service time for the oldest Bovine Valve.

He referred me to their website / product listings, but acknowledged that the dates of implementation of those products is not listed on the site. He suggested talking with the Product Manager(s) for the specific valves but since I am not that familiar with their product names, I declined. He did mention that there was a reference on their website to "27 years of clinical experience" which coincides with the 1983 start date for the 20 year study published in 2003. It is not clear that any of the original valve replacements are still in service. Maybe the product managers have more information on that issue.

If anyone wishes to pursue this investigation further, their toll-free 800 number is available on their website www.edwards.com Note that C-E is based in Irvine, CA in the Pacific Time Zone.

The website for St. Jude Medical is www.SJM.com if anyone desires to contact them about the service life of their Bi-Leaflet Mechanical Valves. Note that SJM contacted Jack Bokros about using pyrolytic carbon components in their valves in 1976 and the first carbon components for that project were produced in 1977.

'AL Capshaw'

 

[Superbob]

The replacement device I settled on -- the Medtronics Freestyle stentless porcine -- to replace the aortic valve and root was approved for general use by the FDA in 1997. So obviously in 2005 I was going with one that had less than 10 years of widespread track record. That didn't matter to me. I liked the design and the thinking behind it -- and still do. If I had waited for a 20 or 30 year track record, I would have died before having the life-saving choice. I was happy with my choice, and still am, going on six years in. Sometimes you have to go with what your gut tells you. I do not care to second guess myself. Indeed I have no reason to do so. I like Neil's philosophy.

 

[Kathy McCain]

I'm with you Bob and Neil. Like my surgeon said, "you've got to move on down the line and get on with your life".


Amen

 

[Ross]

Meh, I can pee further then you can. :biggrin2:

Behold the power of anticoagulation!

 

[Ross]

Luana:

http://www.ncbi.nlm.nih.gov/pubmed/12958549?dopt=Abstract
http://ats.ctsnetjournals.org/cgi/content/abstract/79/3/776

 

[tobagotwo]

Some jumbled thoughts on the topics being touched upon in this thread...

Premature tissue valve failures are going to be overly represented here on the forums. After all, if their valves are working fine, most tissue folks drift back to their former, non-forum life, as there is not the added incentive of warfarin information to tether them here while they develop long-term friendships that cause them to stay.

I would love to blame Medtronic for my early Mosaic failure (and I do, insofar as my individual valve is concerned). But the numbers just don't add up to a pattern, and the early failure examples I've found on the web were often plucked from context, non-valve-related, or second-hand. An example of a reply from Medtronics is: http://www.medtronic.com/mosaic/response/ . Not sure they can really sweep all that under the rug (if there were pannus, the surgeon would have had to remove it, so he or she would know if it was causative), but much of it is reasonably likely to be in their favor. If you visit the FDA site, you find early failures for all types of valves: mechanical, homografts, and animal tissue (xenografts). More than you'd like to think, but a very small fraction overall. It's luck of the draw to be in the wrong part of the percentage.

Nor are the surgeons free from all blame. Most early mechanical failures are lost leaflets, which are frequently considered to be caused by mishandling during surgery. There are similar handling considerations that are sometimes associated with tissue leaflet weaknesses. Most medical device and drug manufacturers discussing adverse reactions are highly reluctant to allude to surgeon or doctor errors as physicians are their primary customer group, and it's not very market-smart to hang your customers out to dry in public. When reading medical exposés, you should always consider that an unmentioned portion of all medical failures belongs to the medical practitioners themselves.

What comes from Al's history of pyrolytic carbon valves is that the first SJM valve was implanted 33 years ago, presumably in clinical trials. We have, I believe, at least one person with a 30-year-old SJM on the forum. Most other PC valves were launched in the late 1980s, making them 20 years old or less, and the On-X (which I would still choose, were I using a mechanical valve) is only about 4 years on the market.

There has to be care taken when reading valve studies, due to the age of the data and also the general age of the participants. The death numbers can be highly misleading, as the average valve recipient is about 65-70. So, if that person doesn't make 25 years, it just means he or she is following the national statistics for average lifespan (76 or so, two years more for women, depending which authority is speaking). The proof of the pudding is in the term "valve-related" when referring to the counting of those who have met their demise. Older people also are more apt to develop comorbidities (other illnesses at the same time) in general.

Issues with mechanical valves tend not to actually be issues with the valve istelf. Usually it's with too much or too little warfarin (bleeding or clotting), pannus, clots on or under the valve, or vegetation (tissue growth on the valve itself). Unfortunately, they engender the same effects and repercussions as a problem with the valve.

There is no study or evidence at this time that backs up any surgeon's claims of 20+ years of average use for any of these tissue valves in people who receive it before age 60 (CEPM-related studies frequenty use 60 as the cutoff age). There are possibilities of it, but no hard facts pro or con yet. I took my first tissue valve (Mosaic) at 52 in the belief that it would do 13-15 years for me and get me to that age where I could expect longer valve life. It only made it for five years, which I do not believe was representative, and which also really sucked on a personal level. However, I still believe 13-15 years should be a reasonable tissue lifespan estimate for most people in their early to mid fifties, assuming the use of one of the "Big Three" tissue valves.

Best wishes,

 

[Hank]

Facts and Data

Facts and Data

I don't know about all that stuff y'all are saying. I do appreciate the conversation though as people looking for answers need to hear the reasonable and the "not so" reasonable and decide for themselves.

I for one think it would be unwise to have a forum overrule the advice of one's Physician.

But I can however bet my life on the following facts and data.

The St. Jude Aortic Mechanical valve will last at least 4133 days which at an average heartbeat of 85 beats per minute... It has lasted 505,879,200 beats thus far.

I am happy with that performance.:thumbup:

 

[ALCapshaw2]

Bob - Check your Math -

The First On-X valve was implanted in 1996. That's 14 years ago, not 4 as you wrote above.

On-X received FDA approval for use in the USA in 2001 (9 years ago).

The last I heard, they have sold over 100,000 valves in over 60 countries.

Math check #2 - the Carbomedics and ATS pivot designs were patented by Jack Bokros ( Ph.D.) in 1985 which is 25 years ago (over 20 years, not under 20 as written)

'AL Capshaw' (posted in 2010

 

[neil]

ross you can only pee further because its the cheap beer you drink...............

 

[Ross]

Premature tissue valve failures are going to be overly represented here on the forums. After all, if their valves are working fine, most tissue folks drift back to their former, non-forum life, as there is not the added incentive of warfarin information to tether them here while they develop long-term friendships that cause them to stay.

Pardon me, It stands to reason then premature MECH valves would be over represented here also- they're not. I don't think any of us anticoagulation people came to this forum for warfarin information- We give it out freely, and set the example. Lord knows everyone is scared of the drug because of mostly nonsense they've been told, but not afraid of surgery.

 

[Ross]

ross you can only pee further because its the cheap beer you drink...............

Ha ha, your wrong! It's the high quality H2O that I get from the Waterboy, Bobby Boucher!

 

[Kathy McCain]

Well, I am still an active forum member, because I just love ALL OF YOU WONDERFUL PEOPLE, despite the bad jokes! (the last part was meant to be funny)