Medtronic failure rates

[Kathy McCain]

Has anyone on this forum heard about the discontinued use of Medtronic Valves? This was posted on Adam Picks web site, not too long ago. Evidently they stopped implanting these valves in two hospitals, because of premature failure rates. All of the patients were over 70, and have to have a re-op.

Click on this link or copy and past browser.
http://www.heart-valve-surgery.com/...pig-heart-valve-replacement-failure-problems/

 

[Lynlw]

Here's the origonal article I saw about it http://www.sciencedaily.com/releases/2009/06/090629165554.htm

4 out of 106 failed, they were all from different lots and got "bumps" on them that no one can seem to identify.. So far only one group seems to be having this problem and reporting it (author Jennifer S. Lawton, M.D., a Washington University cardiothoracic surgeon at Barnes-Jewish Hospital, notes that the valves are expected to last 10 to 15 years in patients over 70. All four patients who needed a "redo" operation were over 70.)
I was wonderring if now that this report is out if other hospitals/surgeon will be going over their records and seeing the same problem or if it is something related to handling at the center.

 

[Kathy McCain]

I have emailed my surgeon in Houston, to get his take on it. I was told both by my surgeon and cardio, that the valve would last any where from 10 to 20 yrs. That the third generation tissue valves were superior. I know the older valves were getting 10 to 15yrs. They both felt very comfortable with this valve.

My second annual echo will be in Feb. I guess I'll find out then. So far everything has been normal.

 

[Lynlw]

I hope everything is fine and it is more hospital handling related than the valve.

 

[marie]

Lovely just what I needed today.

I have an echo scheduled this month and a cardio appointment a week later. I'll let you know what my cardio says

 

[OldManEmu]

Interesting

Interesting

As the owner of said valve it was an interesting story.
This is a problem I hadn't heard of before.
My valve has been in for 4.5 years and at the last echo 6 months ago was functioning normally.
The only problem I had previously read about with this valve and early failure was associated to leaflet tears and this tends to happen in the first few years after placement.
My cardio actually made reference to this last time I met her and we were discussing my valve and its likely service life.
The tears are thought to develop because of improper placement of the valve in the stent when it is manufactured.

 

[Kathy McCain]

Thanks for all the responses. Yes Marie, please keep me posted. I certainly would appreciate it. Good luck, I'm sure it will be just fine. Just thought everyone that has this valve would like to be kept informed.

 

[Dina]

As the owner of said valve it was an interesting story.
This is a problem I hadn't heard of before.
My valve has been in for 4.5 years and at the last echo 6 months ago was functioning normally The only problem I had previously read about with this valve and early failure was associated
to leaflet tears and this tends to happen in the first few years after placement.
My cardio actually made reference to this last time I met her and we were discussing my valve
and its likely service life. The tears are thought to develop because of improper placement of the valve
in the stent when it is manufactured.

My bovine valve is 16 months old and has had increased leakage-originally
it was a trace valvular leak, now its a mild valvular leak which may seem to
support the leaflet tear as you mentioned. I have an appt with my surgeon
now too,but out of curiousity,what did your doc say about it's life expectancy
NOW..? Thanks for any reply; and wishing you the best.

Kathy-Thanks for the heads up,it may not be something we want to face but the sooner we do,
the better,esp for those with CHF or borderline congestive heart failure.

 

[Kathy McCain]

Dina,

My cardio told me, and this was just not more than six months ago, that the new tissue valves were getting 20, sometimes up to 30 yrs. He said they were excellent. My surgeon was a little more conservative. He said any where from 10 to 20 yrs, with the probability of 15yrs, more likely. My surgeon was 60 at the time, (this was last year) and he said he would most likely go tissue himself, because of the improved tissue valves performance. He did say I could go either way, because of my age, which was 56. He said more and more people of that age were choosing tissue. Neither mentioned any premature problems, in the stented valves either, which I have, or any other premature failures in any Medtronic Valves. That is what I based my decision on. What else can you do?? I did not want to take coumanin, or hear any ticking.

 

[OldManEmu]

Valve Life

Valve Life

Dina, I am the owner of a Medtronic Mosaic (Porcine valve) as referred to in the original link rather than the bovine valve you have.
When the valve was placed at age 41 the surgeon believed I would get 10+ years out of it the cardio was slightly more optimistic at 12-15 years.
With my latest cardio appointment she indicated that these valves had now been in use since the mid 90's and the failure rate from calcification (the normal problem with tissue valves) was so low in patients that received valves in their 40's and 50's, that she now felt closer to 20 years likely.
We don't know if the 20 years is going to be the norm until sufficient of the early recipients of the valve get there.
Tears in this model valve are about 1% per year in the first 3 years.

 

[Dina]

Kathy and Emu - Thanks

 

[marie]

Well I could very well be the exception as my valve may be failing. I was told about 15 years and it's been less than 19 months.

 

[Dina]

Well I could very well be the exception as my valve may be failing. I was told about 15 years and it's been less than 19 months.

Yes,its really hard to be the exception isnt it? I'm 20 months post op now
and my leak is moderate,not mild as I previously stated.
What are your doctors telling you? I'm just being 'monitored' for now

 

[Ross]

Here's the origonal article I saw about it http://www.sciencedaily.com/releases/2009/06/090629165554.htm

4 out of 106 failed, they were all from different lots and got "bumps" on them that no one can seem to identify.. So far only one group seems to be having this problem and reporting it (author Jennifer S. Lawton, M.D., a Washington University cardiothoracic surgeon at Barnes-Jewish Hospital, notes that the valves are expected to last 10 to 15 years in patients over 70. All four patients who needed a "redo" operation were over 70.)
I was wonderring if now that this report is out if other hospitals/surgeon will be going over their records and seeing the same problem or if it is something related to handling at the center.

I love how he passes stuff off as his own.

 

[tobagotwo]

"Bumps" (actually too small to see with the naked eye) were an issue I read about very early on in Medtronic valves, and were caused by recrystallization of the AOA® 1,2 (alpha amino oleic acid) used for anticalcification treatments during processing. This could be the same issue resurfacing. I wonder if these affected valves were "the last out of the vat" from various batches, and were in too long or something. (VR's Search function can be useful - I knew I had addressed this issue before, and found it in a piece I wrote for this forum in 2004.)

Lynlw in particular has done some interesting research on valve failure articles.

All valves have failure/early failure rates, not even counting surgical errors (like mis-sizing, a.k.a. patient-prosthetic mismatch). Mechanical valves most often seem to lose a leaflet, tissue valves most often develop tears or leaks, or sometimes go stenotic. It's really a small percentage of either type that fails.

However, it's important to watch whether a particular valve is working up a pattern of failures. They could be significant in terms of a manufacturing fault or other preventable issue. So far, this doesn't seem to be an exotically high failure fate, but it's more than enough to bear watching.

My own Medtronic Mosaic was stenotic right after installation, and the aperture has been continuing to shrink over the last five years. However, that doesn't seem to be the same as the other issues being discussed.

My next valve looks to be an SJM Biocor "mixed grille" tissue valve, which has porcine leaflets and bovine pericardium "bumpers" at the base of the commissures. These have been approved in the US, but SJM has been very low-key on them for some time, and only recently seems to have acknowledged tham with information on their website (prior, the site said "not available in the US").

It may be because of incompatibility with the sales pitches used to promote their Regent mechanical lines, which are their front-line product. Their 20-year data from Europe seems to surpass even the Edwards bovine pericardium data, assuming there is enough apples-to-apples information in the studies to determine that accurately. That CEPM had been my anticipated next valve for most of the last five years, so this decision has been a somewhat difficult change of direction for me.

Best wishes,

 

[DebbyA]

Don't know how I missed this thread back in July...

Here's the Medtronic rebuttal:
http://www.medtronic.com/mosaic/response/

Dina, Marie--can you tell us more about your situations?

 

[tobagotwo]

Hmm. Sounds pretty convincing. However, it still bears watching.

They do sound similar to my issue, as this article recounts it, but no one has been able to spot any pannus or clotting on mine after numerous attempts.

Best wishes,

 

[Nancy]

I am very late to this thread, and maybe I missed something, but it was mentioned that a doctor said the new tissue valves are getting 30 years now. H-m-m-m I don't think the new tissue valves have been implanted in anyone for 30 years, so how can that be a valid statement??

I hate it when puff statements are made to folks who are trying to make life changing decisions.

I think the longevity of any valve can only be assessed after it has been implanted in many folks over many years.

Yes, yes, I know that testing can mimic some wear factors, but cannot mimic an actual implantation in an actual person.

 

[ALCapshaw2]

Good Point Nancy.

The EARLY Bovine Pericardial Tissue Valve recipients are at or approaching 20 years of service. NO ONE to my knowledge has had ANY Tissue Valve for 30 years and NONE of the Improved Tissue Valve Manufacturers have even speculated that 30 years of service would be possible with a tissue valve.

The Doc that suggested 30 years with a tissue valve was "Blowing Smoke".

 

[DebbyA]

Medtronic's "Backgrounder" on their web site claims 30 years of research behind their valves, but that isn't the same as 30 years of human patient usage.

http://wwwp.medtronic.com/Newsroom/LinkedItemDetails.do?itemId=1101862628620&format=print&lang=en_US