Medtronic failure rates

Help Support ValveReplacement.org:

Luana

VR.org Supporter
Joined
Oct 23, 2009
Messages
1,165
Location
USA
I think I have to take credit for much of the derailment as I wanted to get some more definite figures about how long tissue valves last and how long bovine valves have been in use. That led to finding out that even though mechanical valves can last a long time, the newer type of mechanical valves haven't been in use for very long, since the newer models have come about in the past 10 - 15 (quick guestimate) years, though, of course, we do know we have and have had folks here with much older models last quite long.

I was trying to get a Sgt. Friday, "just the facts ma'am," consensus about what's a reasonable length of time to expect a tissue valve to last, which of course, varies by age of the recipient.

So it did kind of branch out a bit, and now it's kind of like ". . .hip bone connected to the thigh bone; thigh bone connected to the knee bone . . . bones them bones, them achin' bones . . ."

I do think some good facts have been found here which will hopefully help those who are pre-surgery to make a decision based on fact vs. somewhat- or sometimes true statements.
 

Lynlw

VR.org Supporter
Joined
Jul 15, 2005
Messages
6,541
Location
NJ
Hey now its my turn to take the blame...I brought up the fact Mechanical valves for the most part also do not have long term data showing they last a life time or even 30 years..
I picked THIS thread to bring it up on, because it was on old thread and it wouldn't hijack a thread where a member was trying to decide what kind of valve they wanted.
 

Kathy McCain

Well-known member
Joined
Jan 10, 2008
Messages
1,087
Location
Texas
So far, I am happy with valve my selection. I have to say this though. PERSONALLY I am very sensitive to various medicines. So the less medication FOR LIFE I can have the better. I guess unfortunately, I have a weird body. I had to make ONE choice, I couldn't have it both ways.
 

Kathy McCain

Well-known member
Joined
Jan 10, 2008
Messages
1,087
Location
Texas
Luana,

I agree with your concern over what surgeons are saying regarding tissue valve life. My surgeon told me at the time of my surgery, which was 56my valve would life expectancy would be from 10 to 20 yrs. He is regarded as one of the very best. However, he also said that younger patients could expect less. Yes, I do believe that more Dr's need to be up front about valve longevity.
 

Luana

VR.org Supporter
Joined
Oct 23, 2009
Messages
1,165
Location
USA
Kathy,
You bring up another good point about having an excellent surgeon. I think most of us who live in large metropolitan areas, or who travel to one for surgery, end up with better doctors than those in a small city or rural area. The best and the brightest CT surgeons aren't likely to settle down and start a practice in the middle of nowhere. I saw this with the difference in the back surgery I had and what my brother had. Mine was a success, his wasn't. He lives in the middle of nowhere and I can't help but think part of the reason he became permanently disabled and now lives daily with severe pain was due to a crappy surgeon.
 

Ross

Observer
Joined
Dec 16, 2001
Messages
25,981
Location
On The Hot Seat
Two interesting items:
1, The 20th of this month will be Twinmakers 29th anniversary of her twin St. Jude valves
2. MAMOOJR had her 33 year old Kay disc valve replaced because although it was working fine
she had to have surgery done for other reasons and CC decided to replace the valve in favor of a newer one.
 

Lily

Premium Level User
Joined
Oct 18, 2009
Messages
1,034
Location
private
Some posts are missing again.

. . . 2. MAMOOJR had her 33 year old Kay disc valve replaced because although it was working fine she had to have surgery done for other reasons and CC decided to replace the valve in favor of a newer one.
Is MAMOOJR a member here? I couldn't find a member with that name.
 

Lily

Premium Level User
Joined
Oct 18, 2009
Messages
1,034
Location
private
There are several members here on the site with these Mosaic valves.

I wanted to add the status of mine and have been waiting for my annual to do so. Mine is seven years old and in the aortic position.

During my recent annual, I asked my cardio, point blank, how my valve is doing, how it is functioning. His reply was that it is doing, "Very well." As you can imagine, I was very happy to hear that.

My gradients are getting higher as my valve opening gets smaller; and the valve has been described on my echo report as "abnormal;" my cardio told my husband and I that this is because of the valve opening size, which has been measured between 1 and 1.13 for the past three years.

He also volunteered to me, when I asked him how much longer this valve could work for me, that I could get ten or even twenty years out of it but that we just couldn't tell now. I was shocked. And very relieved (because I had feared the worst, due to the higher gradients and the echo using the description of "abnormal").

I also grilled him about the Avapro hypertensive medication that I am currently on. He said it is a good one, having some of the fewest side effects. So I guess I'll stay on it for the time being.

I am having some other issues, hopefully just more PVCs, and am still awaiting Holter monitor results.

Hoping my relatively good report might encourage others on the site who also may be concerned about their valves :)

Adding this edit: I've been put on [the generic for] Toprol XL because of continuing and excessive PVCs. Rats. Another pill.
 
Last edited:

Kathy McCain

Well-known member
Joined
Jan 10, 2008
Messages
1,087
Location
Texas
Thank you Lily, for that wonderfully encouraging report!! I am very happy for you! I know you are very relieved. My next echo will be in exactly 6 mos. I spoke with my Cardio, last week. My appointment is for, the way I understood it, another consultation, and maybe an echo. I thought that rather odd. I think I will call his office, and insist on an echo.
 

Harmony

Well-known member
Joined
Jan 11, 2005
Messages
145
Location
New York, NY
I had my Mitral Valve repaired 1 1/2 years ago. Does all this talk here only relate to valve replacements or are valve repairs at danger too
 

Kathy McCain

Well-known member
Joined
Jan 10, 2008
Messages
1,087
Location
Texas
Hi Harmony,

The best thing to do is start a NEW thread, regarding the longevity of valve REPAIRS. I'm sure you will receive quiet a few responses.

Take care
 

tobagotwo

VR.org Supporter
Joined
Feb 10, 2004
Messages
5,228
Location
Central NJ
One note on anything regarding longevity of valves. There is a built-in limitation to the numbers. As the normal lifespan of humans in the US is between 72 and 76, depending who you talk to, and the average age of people who have valves implanted is 65-69 (again depending on which article you read)...

Well, there's an issue getting recipients past that expected lifespan. Regardless of what valve they have. This obviously affects length of survivorship numbers, but also decreases the pool of people who wind up testing the valve for extended periods. If a fellow were 65 when he received the valve, he'd have to live to 95 in order to have it for 30 years.

So key in on the explantation results, to get useful stats. Recipient survivorship length can be useful information, but age is an overwhelming factor in it. To make more sense of post-implant lifespan, there is often also an accounting of those who met a "valve-related" demise.

As far as 30 years on a current tissue valve, I think it will eventually happen. Once or twice, or maybe even to a handful of patients. However, I don't believe that it will be anywhere near the norm. Most of the people who would be able to carry it for 30 years will be young, and the chemistry of youth is the Achille's heel of today's tissue valves.

Best wishes,
 

OldManEmu

Well-known member
Joined
Jul 18, 2005
Messages
953
Location
Melbourne, Australia
Bob
So key in on the explantation results, to get useful stats. Recipient survivorship length can be useful information, but age is an overwhelming factor in it. To make more sense of post-implant lifespan, there is often also an accounting of those who met a "valve-related" demise.
Thats the key to meaningful stats on valve longevity.
I tend to agree on the 30 year valve life, this is longer than the adult life of the donor animal, so nature hasn't designed it to last that long.
 

Lynlw

VR.org Supporter
Joined
Jul 15, 2005
Messages
6,541
Location
NJ
Bob

Thats the key to meaningful stats on valve longevity.
I tend to agree on the 30 year valve life, this is longer than the adult life of the donor animal, so nature hasn't designed it to last that long.[/QUOTE

Pericardial Bovine valves aren't actual animal valves, they are man made using the treated pericardial sac tissue. And tissue valves that are actual valves from animals are also treated, unlike the valve still in an animal or human, so I don't think the natural life span of the animal they come from has much to do with how long they will or won't last.
 

Lily

Premium Level User
Joined
Oct 18, 2009
Messages
1,034
Location
private
OldManEmu, I'd never considered that before; fascinating.

And Bob, as usual, very interesting explanation and information.

This really doesn't have anything to do with either of those posts -- but for me, I felt like a tissue valve would just be more gentle on my system, would be more harmonized with how the body was originally designed, would allow my heart to more smoothly return to a better function, would naturally be more compatible with what I already had.
 

normofthenorth

Well-known member
Joined
Nov 1, 2010
Messages
862
Location
Toronto, ON, Canada
I've posted this info elsewhere on this site, and I'm not sure I've found the right place yet! ;-) But there's a new study that I just got (fax image only) from my surgeon's office, which seems impressive and important to me. It's entitled "Hancock II Bioprosthesis for Aortic Valve Replacement: The Gold Standard of Bioprosthetic Valves Durability?" by Tirone E. David, MD, Susan Armstrong, MS, Manjula Maganti, MS, in Ann Thorac Surg 2010;90:775-781, abstract at ats.ctsnetjournals.org/cgi/content/abstract/90/3/775? .

It'll cost you $25 to get the full text online, unless you (or a pal) have access, e.g. through a University Library.

Retrospective results on 1100-odd recipients of that one pig valve from 1982 to 2004. Not many (3!) still ticking after 25 years, but they just started using this valve 28 years ago -- plus the natural mortality issue raised above by Bob. But the 10- 15- and 20-year results seem quite reassuring to me, both as absolute numbers and in comparison with the pericardial (cow) valves.

I'd read online SOMEWHERE (I thought it was in a "sticky" on valve-selection here, maybe repeating one of Bob's posts -- but I can't find it!) that cow valves seemed to last 5 years longer than pig valves, on average. Yet my fancy surgeon in a fancy big-city hospital cardio department (headed by the illustrious Tyrone David, yet!) said he planned to replace my BAV with a pig valve! So I asked him why he prefers pig to cow, when "the studies" seem to show that cow lasts longer.

In an earlier visit, I'd challenged him with another study I'd seen online, apparently proving that a bovine valve has a higher more unobstructed flow rate (lower pressure gradients) than a pig valve of the same size. He told me he thought it was a misleading result, because the valve sizes are measured differently. So if you compare the flow through a pig valve and a cow valve of the same "nameplate" size, like 25mm, you're actually comparing a big cow valve with a smaller pig valve. You wouldn't use the same "nameplate" size as alternatives in the same patient. I haven't checked into that, I'm just repeating what he told me a few months ago. (I've very recently been very athletic, and if one valve is more likely to let me return to "competing my heart out" without. . . ACTUALLY competing my *heart* out, then that's the one for me, of course!)

A week ago, I challenged him again, but this time it was about valve LONGEVITY, based on that 5-year difference I read somewhere. He told me that they had a lot of experience themselves, and that their results were the opposite -- they were getting better longevity out of pig valves than anybody was reporting from cow valves. I asked him if he could send me the study, and he told his assistant to e-mail it to me. Instead, she faxed it, but I've got it. It seems to say exactly what he says it says, and the study looks careful and well done to me. (BTW, the HancockII valve is also made by Medtronic, along with the Mosaic and the Freestyle. Busy company!)

Some disclaimers, in addition to the system-wide disclaimers about "medical advice" etc.:

This subject is obviously important and serious. What's the "funny" cliche, "as serious as heart surgery"? And we're discussing comparisons among EXCELLENT valves, all of them huge improvements on the bicuspid, stenotic, regurg one I'm using now. It's hard for humans to discuss this kind of evidence without getting emotionally involved -- either "my valve is better than your valve" or worrying that we went through OHS just to get a "loser" valve installed. I've always been pretty good at "compartmentalizing" those kinds of discussions (science is science and choices are choices), but that's me, and I'm weird that way.

One other thing: I've often been involved in clinical-treatment discussions (most recently at AchillesBlog.com) where I put the physician's comfort WAY down at the bottom of my priority list. Now, facing valve replacement, I'm surprised how important it is to me, that my surgeon and his team feel comfortable while they're operating on my heart! Pig vs. cow, mini-thoracotamy vs. full sternotamy, Kryptonite glue or just wires. . . I have never been somebody who just does what my Doc says because (s)he says it (or puts my fate into the hands of ANY expert!). But I'm suddenly relatively happy to let these experienced professionals use their judgment and operate right in the sweet spot of their Comfort Zone! I THINK I'm being rational about this, but who knows?
 

normofthenorth

Well-known member
Joined
Nov 1, 2010
Messages
862
Location
Toronto, ON, Canada
If you're having trouble with the link, here's the abstract:
Background: This study examined the long-term durability of the Hancock II bioprosthesis (Medtronic, Minneapolis, MN) in the aortic position.

Methods: From 1982 to 2004, 1134 patients underwent aortic valve replacement (AVR) with Hancock II bioprosthesis and were prospectively monitored. Mean patient age was 67 ± 11 years; 202 patients were younger than 60, 402 were 60 to 70, and 526 were older than 70. Median follow-up was 12.2 years and 99.2% complete. Valve function was assessed in 94% of patients. Freedom from adverse events was estimated by the Kaplan-Meier method.

Results: Survival at 20 and 25 years was 19.2% ± 2% and 6.7% ± 2.8%, respectively, with only 34 and 3 patients at risk. Survival at 20 years was 54.9% ± 6.4% in patients younger than 60 years, 22.7% ± 3.3% in those 60 to 70, and 2.4% ± 1.9% in those older than 70 (p = 0.01). Structural valve deterioration developed in 67 patients aged younger than 60, in 18 patients aged 60 to 70, and in 2 patients older than 70. The freedom from structural valve deterioration at 20 years was 63.4% ± 4.2% in the entire cohort, 29.2% ± 5.7% in patients younger than 60 years, 85.2% ± 3.7% in patients aged 60 to 70, and 99.8% ± 0.2% in patients older than 70 (truncated at 18 years). Repeat AVR was performed in 104 patients (74 for structural valve failure, 16 for endocarditis, and 14 for other reasons). At 20 years, the overall freedom from AVR was 65.1% ± 4% for any reason, 29.8% ± 5.4% in patients younger than 60 years, 86.8% ± 3.3% in patients 60 to 70, and 98.3% ± 0.6% in patients older than 70.

Conclusions: Hancock II bioprosthesis is a very durable valve in patients 60 years and older and is probably the gold standard of bioprosthetic valve durability in this patient population.
I think the most important results are these:
"The freedom from structural valve deterioration at 20 years was 63.4% ± 4.2% in the entire cohort, 29.2% ± 5.7% in patients younger than 60 years, 85.2% ± 3.7% in patients aged 60 to 70, and 99.8% ± 0.2% in patients older than 70 (truncated at 18 years)." They present graphs and such that let you estimate the numbers for your own age, for this data and lots of others. The "Comment" section compares these results (favorably) with those from other studies on different valves.

They also say that several earlier studies (they cite 3) use two different numbers interchangeably: "freedom from structural valve deterioration (SVD)" and "freedom from reoperation for SVD". In these 1100-odd patients, 87 patients had documented SVD, but 13 of them were deemed inoperable, so only 74 had "explant" surgery. It's obviously misleading to exclude those 13 from the negative results, but that's what they say at least three earlier studies did. (Yes, I'm a "study geek"!:eek:)

The raw survival numbers seem sobering, but I think that's because I haven't gotten used to being 65 years old!:) I wish they'd presented comparable numbers from the whole population, but I guess I could find them easily enough.

I'm sure this isn't the last word, given the importance of this issue, in terms of both health and gazillions of dollars.
 
Last edited:

Latest posts

Top