Medtronic failure rates

[Lynlw]

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

I looked to see when the different valves were first used in the US since it looks like people are interested. My original point was just that there is not Data proving mechanical valves last a life time -which is tricky since a lifetime can be shortly after you got the valve- so I just mentioned like the tissue there aren't many patients who've had their original mechanical valves (used today) valve over 30 years, let alone 50 which I'm sure many people are hoping for, simply because they haven't been around that long.

Chances are I missed some earlier studies, but from looking at ATS, Carbomedics and Edwards sites as well as PUBMed this is the earliest I personally found. (also it makes sense that a valve probably wouldn't be in a patient the same year it is patented, again because things take time)

Heart Surg Forum. 2001;4(4):346-52; discussion 352-3.
The initial United States experience with the ATS mechanical cardiac valve prosthesis.
Emery RW, Petersen RJ, Kersten TE, Stokman P, Harris KM, Knickelbine T, Longe TF, Macaya J, Nicoloff DM, Arom KV.
Cardiac Surgical Associates, P.A., John Nasseff Heart Hospital, St Paul, MN, USA.
Abstract
From January 1, 1997 through June 30, 2000, 224 patients underwent valve replacement with the ATS Medical cardiac valve prosthesis under a USFDA-approved investigational device exemption study. Aortic valve replacement (AVR) was conducted in 152 patients (39 with coronary bypass) and mitral replacement"

if anyone is interested there is a list of references at the bottom of this page http://www.atsmedical.com/Physicians.aspx?id=1418
also there was a study from france that started in 1996 Clinical Experience and Doppler Echocardiographic Assessment of the First One Hundred ATS AP (Advanced Perfomance) Prosthetic Valve in the Aortic Position

The earliest I could find for Carbomedic is http://www.ncbi.nlm.nih.gov/pubmed/7944682
Four-year experience with the CarboMedics valve: the North American experience. North American team of clinical investigators for the CarboMedics prosthetic heart valve.
multicenter prospective trial of the CarboMedics valve was initiated in July 1988. Twelve North American centers were included for the purpose of establishing the safety and efficacy of this new rotatable, bileaflet, pyrolytic-Carbon prosthesis. The study included 786 patients (using 891 valves) enrolled between July 1988 and August 1992. There were 447 male and 339 female patients from ages 2 to 83 years

and the Earliest study in the US I see for the Perimount (the 2nd generation) started in 1981

http://jtcs.ctsnetjournals.org/cgi/r.../131/3/558.pdf

Under Patients and Methods it states
"Patients
Pericardial prostheses. Clinical investigation of the Carpentier-
Edwards stented bovine pericardial bioprosthesis (PERIMOUNT;
Edwards Lifesciences LLC, Irvine, Calif) began in 1981. Between
September 1981 and January 1984, 267 patients with isolated
aortic valve disease (with or without ischemic heart disease) had
this prosthesis implanted at 1 of 4 centers as part of the premarketing
clinical investigation for the US Food and Drug Administration.
Results of its durability to 17 years after implantation have
been reported,8"

 

[Ross]

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)

It's just the usual squabbling. You'd think we'd all give it up, but nope. Gots to stand up for what you believe in. Tends to make us all stubborn cusses.

 

[tobagotwo]

I shouldn't try to do these posts at night...

Al, I referred to the On-X hitting the market four years ago. That's not the first implantation. That's when I believed it was approved by the FDA to market and use freely. However, I was wrong about it (mea culpa: there may have been a model change or model size addition that required an additional approval four years ago that tripped me up). And it appears that you may be mistaken as well with the 2001 date. Here's MCRI's summary On-X FDA submission and the result: http://www.accessdata.fda.gov/cdrh_docs/pdf/P000037S001b.pdf

FDA issued an approval order on March 6, 2002

. From a separate source: http://intermountainhealthcare.org/hospitals/mckaydee/about/news/Pages/home.aspx?NewsID=444

The On-X valve has been FDA approved for use in the U.S. since 2002. There have been approximately 100,000 implants world-wide...

The ATS and Carbomedics valves were patented in 1985. That's not the approval date for surgical use. From ATS: http://www.atsmedical.com/Company.aspx?id=992

The ATS Open Pivot Heart Valve was first sold in international markets in 1992. FDA clearance to sell the valve in the United States was granted in October 2000.

The Carbomedics valve came sooner, however: http://cardiacsurgery.ctsnetbooks.org/cgi/content/full/3/2008/1031?ck=nck

The Carbomedics bileaflet valve was approved by the FDA in 1986...

, so it has been in use for almost 25 years.

Ross - The vast majority of valves being implanted are tissue - over 75% even as early as 2006, per the Society of Thoracic Surgeons. That's why St. Jude finally relented and brought their tissue valve over from Europe, as their part of the market was shrinking so badly. Yet the forum tends to run more heavily mechanical valve oriented than tissue. If the tissue valvers hung around much after surgery, that simply would no longer be the case. By default, they would overwhelm the forum by a 3 to 1 margin. So, where are they? I repeat, by far most tissue recipients leave the forum after their early recovery, and only come back when they face another heart issue. Unless you've been eating them again..?!:eek2:

Best wishes,

 

[Ross]

Hey the only reason why some of the mechanical people are around is because they want to offer their advice when Coumadin concerns arise and risk of reops are discussed. Most all of them move on too. Last time I checked the In Loving Memory Forum, no one had died of mechanical valve failure nor anticoagulation, but they certainly have of repeat surgeries.

First of all the mean age of HVRs is 65- that means half are over 65 and the the other half under 65. The ACC guidelines calls for tissue valves in most cases for people over 65- ergo at least half the surgeries should be tissue. There are good cases for certain pts under 65 to get tissues valve. In other words, of course there are more tissue valves being implanted because there are more people who are 65 and older or fall in to a special case. Furthermore, the boomer are aging, RF and other valve problems are affecting them in their over 65 age group.

The only thing I know for a fact is a lot of long time Mech valve, the most experience there are, have left vr because of the absurd statements being made about ACT, the wishful predictions of tissue life in young people and the failure to recognize the co-morbidity effect of multiple surgeries as people age. Show me someone with four surgeries over the age of 30 and up and I'll show you a compromised physical state!

Not to add fuel to the fire, but our newest member is an old member returning, because of tissue valve failure.

Well, as always, we can play badminton forever, but I would hope that those wanting to learn a few things, have. This thread is to usual stall point, so I'm moving on to other things.

 

[Kathy McCain]

I suppose someday if I don't die from something else first, I will need another surgery, but like I said before, I enjoy the company. We've got alot of TERRIFIC Forum members. I consider ALL OF YOU, as one of our forum members so rightly expressed, my valve brothers and sisters.

 

[ALCapshaw2]

TobagoTwo wrote:

"Al, I referred to the On-X hitting the market four years ago. That's not the first implantation. That's when I believed it was approved by the FDA to market and use freely. However, I was wrong about it (mea culpa: there may have been a model change or model size addition that required an additional approval four years ago that tripped me up). And it appears that you may be mistaken as well with the 2001 date. Here's MCRI's summary On-X FDA submission and the result: http://www.accessdata.fda.gov/cdrh_d...00037S001b.pdf FDA issued an approval"
------------------------------------------------------------------------------------------------------------------

Actually, On-X had sold Tens of Thousands of Valves to the World Market before they got their FDA approval
in 2001 and 2002 according to footnote #25 on the Jack Bokros biography sheet which states:
" Summary of Safety and Effectiveness, On-X Prosthetic Heart Valve, FDA PMA P000037 and P000037/S1,
May 30, 2001 and March 6, 2002.

(Why the 2 dates? Maybe one was for their Aortic Valve and the other was for their Mitral Valve.
I will have to check on that...)
EDIT: Yep, exactly as I thought, P000037 = On-X Aortic Valve Approval May 30, 2001
P000037S001 = On-X Mitral Valve Approval March 6, 2002

In 2006 (4 years ago) the FDA approved the first ever reduced anticoagulation study,
PROACT Investigation Plan, On-X Life Technologies, Inc. (tm) Austin, Texas, USA.

(The 2006 FDA action had Nothing to do with Approving their Valves,
but approving a Study of Low Anticoagulation with their valves. Important Difference!)

Note: It would appear that On-X "hit the market" in the USA in 2001 or 2002 but I can check that if you want confirmation.
I see that your source and my source concur on their total sales of approximately 100,000 units as of this year (2010).

'AL'

EDIT:
From the FDA website:

On-X® Prosthetic Heart Valve - P000037
This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.


--------------------------------------------------------------------------------

Product Name: On-X® Prosthetic Heart Valve, Model ONXA
Manufacturer: Medical Carbon Research Institute (MCRI™), LLC
Address: 8200 Cameron Road, A-196, Austin, TX 78754
Approval Date: May 30, 2001
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf/p000037a.pdf

What is it? The On-X® Prosthetic Heart Valve is a mechanical heart valve with two movable half-discs (“bileaflets”), contained within a housing surrounded by a man-made fabric-covered ring. (The fabric is poly-tetra-fluor-ethylene). The leaflets are made of graphite and tungsten, with a carbon coating. The valve is used to replace a patient’s own aortic valve or another implanted prosthetic aortic valve.

---------------------------------------------------------------------

Note the P000037S001 Approval for the On-X Mitral Valve on March 6, 2002 is in pdf format which I am not able to copy.
Google that number and click on the link to view the approval.

----------------------------------------------------------------------

BTW, while searching the FDA website for the On-X Mitral Valve approval in March 2002,
I noticed the FDA approval for the St. Jude REGENT (Aortic) Valve, P810002/S057, on March 4, 2002, which was 10 months after the On-X Aortic Valve approval.

'AL Capshaw'

 

[LLJ]

ooo-am I the old member returning because of tissue valve failure?? Wow-fame at last!!!
(BTW the new Dr Rockstar said the valve leaflet doesn't appear to have failed but instead the valve itself has "popped a stitch" and come away from it's base--unusual in a 5 year old valve-he will know more whenhe gets in there a visualizes next Tuesday Aug 3rd)

 

[Luana]

It's just the usual squabbling. You'd think we'd all give it up, but nope. Gots to stand up for what you believe in. Tends to make us all stubborn cusses.

Well, I think this thread has clarified some facts, which is a good thing, especially when making a decision on which type of valve. When I have a few more minutes, I'd like to make a list of the facts that have been found here. Feeling like Sgt. Friday, just the facts, ma'am.
Over and out.

 

[ALCapshaw2]

Lyn,

I confess, I am impressed with the results of your Research.
I'm sure that several of our members (including myself) would be interested in how you go about conducting your research.
After a few pages of Google Links, I tend to just throw in the towel.

Here's another topic of interest raised by this thread if you care to tackle it (or how you would approach the subject):

(Accelerated) Lift Test Data for (Mechanical) Heart Valves. It may be easier to just specify a particular manufacturer and try to locate their Life Test Data or Durability Data.

I can't imagine a manufacturer NOT performing Accelerated Life Testing on their Products
to see how they perform after either a defined amount of time or number of cycles of operation.

I found an interesting article that discussed Accelerated Life Testing, but was not able to quickly locate any actual Data (on the SJM website since they have the longest track record of manufacturing Bi-Leaflet Mechanical Heart Valves).

'AL Capshaw'

 

[Lynlw]

Thank you Al. To be honest, when I'm searching for anything medical, I usually start with pubmed.com I try a couple different word combinations to narrow down the results. for example I searched "St Jude Valve" first then since I was looking for the earliest studies I went to the last page (oldest studies) of the results first, (when looking for the newest I scan the first couple pages of results.) To find a little more I would try St Jude valve and longterm or midterm (2 separate searches) to find some of the studies like the 20 year experiences that say we used these valve from say 1981-1984 ect.
(with SJM you need to mention valve at pubmed or you end up with lots of studies from st jude hospital) the other valves I just searched "Edwards pericardial" or bovine "Carbomedic bileaf"ect. Sometimes IF I know a certain center did some of the earlier work (like CCF and the perimount) I narrow it down even further by putting the author..like cosgrove ect if I don't know who the authors are, IF I find one or 2 studies you can click on any of the authors in that study and see their other studies.
But with pubmed you only can find studies that have been completed and written up/published. Which work well for the history or to see what the majority of studies show about something in particular, but not newer things. So when I'm interested in seeing what is in the horizon,what they are working on now, ect I find alot of good info on http://clinicaltrials.gov/
To see what is going on right now, how things are going, and hear it from the doctors actually doing the work, I find alot of the webcasts from the different AATS conferences (American Association for Thoriacic Surgeons are very interesting, it is where many of the other doctors learn what is going on And usually some of the sessions are by the leading doctors in the UK, Europe ect so you can hear how things are going there too since they are often allowed to try new things before they can in the US.
The 2010 are up now but you can also watch past ones http://www.conferencearchives.com/aats/2010/ IF anyone hasn't watched them, because they think they might be very technical or hard to understand, When I first started watching I was surprised at how easy they are that a patients usually could follow and understand if you know the very basics (and if you are a member here you DO know enough of the basics) and they usually have good graphs, pictures. At the end of most sessions (which are anly about 20 min or less, there usually is a Q&A and many of the doctors in the audience ask the questions we all seem to have, so that part is interesting too but very short)
I have to confess I also an a VERY fast reader, always have been, which really helps when I can scan thru different studies very quickly to see if it has what I'm looking for (for some reason in the abstracts many studies don't mention what year they started or went to..it drives me nuts) I read the last Harry potter book (about 800 pages) in a weekend so can scroll thru alot of abstract in a pretty short time.


Funny you should mention the testing done before valves (or anything medical) ever makes it to the first human being. I know they tests all valves, not just mechanical and put them thru all kinds of extreme paces before they even try to start trials/get approval, so I was actually looking for that. I searched the different valves and also put "in vitro" (for anyone who doesn't remember "in vitro" means in the test tube or test done with machines ect In Vivo mean in a living person (or animal in some cases) I found a few mentions but not alot of really useful data.
I *THINK* that might be able to be found at the FDA site but That is a site I still don't find very user friendly and like you say after a short time I throw in the towel an admit defeat.

FWIW lately I've been finding alot of good articles, different video disscusion (like this on percutneous at http://www.theheart.org/article/1086029.do ) It is a site mainly for heart doctors, but anyone can register for free and read the articles watch the videos ect.
and I find their search feature is pretty easy

 

[ShezaGirlie]

Thank You, Muchas Gracias..!!

Thank You, Muchas Gracias..!!

I would like to take this opportunity to thank the brilliant minds who continue to research and share their findings with all of us. It is indeed a concerted effort on their part which benefits all of us.

So, thanks to you Lyn, Tobagotwo Bob and Al Capshaw..!! Y'all rock..:thumbup:

 

[ALCapshaw2]

Thanks for the research tips Lyn.

How did you develop your speed reading skills?

I could certainly benefit from some improvement in that area!

'AL'

 

[Duffey]

Yeah, I'll probably need to use the research somewhere down the line again.

In the meantime, I'm happy with the valve I've got. Even happier not to be messing with act.

The cow probably wishes I'd picked differently.

 

[Duffey]

Al,
I'd venture a guess that Lyn's ability to read the studies as quickly as she does is a result of her medical background. Plus the added experience of researching her child's medical condition for 21+ years probably plays a part, too.

 

[Lynlw]

Thanks for the research tips Lyn.

How did you develop your speed reading skills?

I could certainly benefit from some improvement in that area!

'AL'

Honestly it was just something I was lucky to be able to read fast since I started learning to read. I also LOVED reading when I was growing up nancy Drew Hardy Boys ect. Both my parents were "readers" so part of it probably came thru them. I wish I could teach how I do it, since Justin's learning problems are language art, reading, spelling, writing and his school life would be so much easier for him, if reading wasn't such a challange. He does well learning by hands on, or audio visual type things.

 

[Shobu]

I had a CryoLife human donor valve implanted in 2002, and late 2009/early this year my cardio noted a big change in leakage across the valve. Just had surgery to replace it with an on-x valve (I really don't want OHS again if it can be helped and the surgeon (Dr Mark Stout, who did my original surgery as well) commented in how calcified and stenotic the valve was. Both my cardiologist and surgeon were fairly surprised as they were expecting it to last about 15-20 years rather than the 7-8 that it did. Interestingly, CryoLife uses a process in preparing the valves that is supposed to help reduce the likelihood of calcification, although I'm guessing it didn't work in my case The last couple of years were incredibly stressful, so who knows how that could have affected my tissue valve. Happy with the on-X so far, although I don't regret the decision for tissue at the time (I was 28) It was the right valve at that time for me.
I guess that is the problem with "average valve life expectancies": not all of us make it to that average.....


--Dan

 

[Nancy]

Well, you are not the only one who had that problem, we've had several who did.

 

[Luana]

Dan,
I'm guessing you're under 40?

 

[ALCapshaw2]

Dan,
I'm guessing you're under 40?

28 + 7 = 35

 

[Luana]

28 + 7 = 35

Duh, I'm sorry. I totally did not see that. Thanks for doing the complicated math for me, Al.
So, at age 28, the doc said he'd get 15-20 years from that valve. Is that based on wishful thinking? This is what really irks me about surgeons and what they say about time-frames with tissue valves, and in particular with what he had, a human donor valve, which I was told would have gotten me maybe 7 or 8 years. Gee, guess that estimate wasn't too far off.

How is it that surgeons are spouting out such vastly different numbers?