Medtronic Freestyle Root Bioprosthesis

Valve Replacement Forums

Help Support Valve Replacement Forums:

This site may earn a commission from merchant affiliate links, including eBay, Amazon, and others.

Wendel

Member
Joined
Dec 28, 2023
Messages
17
Location
Argentina
Hello, I recently had Bentall surgery where I had a Medtronic Freestyle Root Bioprosthesis fitted. I am 40 years old. I have read two people here claiming that the valve has lasted 18 years, I would like to read more testimonials. There is too much evidence and information about this prosthesis on the internet. I appreciate that only information related to the subject and people who have or have had this valve is published. Thank you.

https://europe.medtronic.com/xd-en/...ical/freestyle-aortic-root-bioprosthesis.html
 
Last edited:
Good moring from Australia
Hello, I recently had Bentall surgery where I had a Medtronic Freestyle Root Bioprosthesis fitted. I am 40 years old. I have read two people here claiming that the valve has lasted 18 years, I would like to read more testimonials. There is too much evidence and information about this prosthesis on the internet. I appreciate that only information related to the subject and people who have or have had this valve is published. Thank you.

https://europe.medtronic.com/xd-en/healthcare-professionals/products/cardiovascular/heart-valves-surgical/freestyle-aortic-root-bioprosthesis.html
testimony is worth whatever survivor bias suggests it is worth.
1728339929302.png


despite the various manufacturers peddeling myth and hope there has been no significant change in bioprosthetic valve durability since the 1980's

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10449611/

every word of that article deserves to be read, parsed and understood.

So while you can see that there is statistics there is also the outliers. It is a mistake to assume you'll be an outlier.

1728340086402.png


so if the average is 15 years then to understand it you'll need to know the standard deviation (represented as σ). For instance you may get 2σ longer or shorter but that's unlikely I would suggest that the data shows that (despite marketing hype) you'll get about what the literature suggests for your age group.

If there was a magic bullet we'd all have taken it ... I hope that you get 15 years from the valve. Getting 20 may not be ideal for a variety of reasons.

Best Wishes
 
@pellicle Is it necessary that you write the same thing in every post? You only criticize the duration of biological valves and try to convince people to choose mechanical valves. Here you are seen as a guru, and you are a simple man who dedicates himself to writing in a forum. I am not interested in the outdated information that you provide. I have been reading you for 10 months and it seems that this is your job, I will tell you one thing: If the valve lasts me 1 year, I will be happy that year, I prefer quality to quantity of life. The progress of biological valves has been amazing, and the world of science says so. I'm going to believe them and the doctors and not you, I don't know you and apparently you don't have a university degree. Now yes, goodbye. >>> OFF TOPIC
 
Is it necessary that you write the same thing in every post? You only criticize the duration of biological valves and try to convince people to choose mechanical valves.
clearly you have only read a small portion (or remembered that) ... I often write that for many people the choice of a bioprosthesis is likely the best choice.

Here you go ...
I frequently say to people that if they are not going to properly engage with anticoagulation, properly manage their ACT then they should seriously consider the tissue valve choice.

I don't know you
clearly ...

I'm sorry you are offended by facts.
 
Last edited:
Actually, pellicle’s reply was spot on. He didn’t criticize you or your choice. He simply provided the facts. And those facts aren’t outdated. They are real. If you have medical studies that refute what he has given please post those studies here.

You want people here to confirm and validate your valve choice … so that you feel better about your choice of a tissue valve at 40. I, personally, won’t validate that. But maybe someone here will. I’m not sure why they would though. The current medical advice is to use a mechanical at your age. When I got my valve I was so so so so torn on what to get. One question made all the difference for me. I asked my surgeon what HE would get if he was 50yo and needed a new valve. He said mechanical.

The facts show that you’ll be back in the hospital for another surgery. Could be 15 years. Could be 10. Nobody knows for sure. That’s just the facts. Tissue valves haven’t come THAT far yet. Notice my use of the word “yet”. Maybe one day, but that day isn’t today. Unfortunately.

Your comment on Quality of life makes no sense. Truly. Anticoagulants don’t change much of anything in terms of how you live your life. My life hasn’t changed. I’m still working out. I’m jogging. I work on my vehicles. I do house projects. I regularly target shot with high caliber firearms. I ride my skateboard. I eat whatever I want (except grapefruit and cranberries).

What’s ironic here is that you’re using quality of life as a reason and yet you’ve literally chosen a path that puts you back in the hospital at least 2 more times for heart surgery. At least 2. Maybe more. Theoretically, with a Mech valve you would have set yourself up for no more operations. Additionally, at 40yo you’re gonna wear out that valve quicker … especially if you’re active. Again - these are facts.

The biggest source of mortality/death is more heart operations. That’s a medical fact. And the recovery is harder as you age. That’s not a good quality of life from my perspective. Just my humble opinion though.

I wish you all the best. I truly do. I really hope that you get the rare 20 years out of the valve.
 
@Timmay Another guy from the "mechanical valve sect". I'm not interested in your opinion at all, in fact I haven't read everything you've written, I'm not here to put up with traumatized people. You don't contribute anything here either. Science and evidence cannot be denied, the increase in biological valves in young patients is a worldwide fact. Good luck with your anticoagulants and your eternal noise.
 
Hello, I recently had Bentall surgery where I had a Medtronic Freestyle Root Bioprosthesis fitted. I am 40 years old. I have read two people here claiming that the valve has lasted 18 years, I would like to read more testimonials. There is too much evidence and information about this prosthesis on the internet. I appreciate that only information related to the subject and people who have or have had this valve is published. Thank you.

https://europe.medtronic.com/xd-en/...ical/freestyle-aortic-root-bioprosthesis.html

Hello, I don't have information on your specific valve but I recalled reading an interesting propensity matched study a while back that you may find helpful.

https://www.jtcvs.org/article/S0022-5223(17)31896-2/fulltext

Large study with the average age being 43. Reoperation rate in Bioprosthetic was 24.9% at 15 years and 9.3% in mechanical. Some good data on other relevant topics such as bleeding events, stroke, etc...

It also touches on the massive increase in biological valves (from 14% in 1997 to 47% in 2014) and the implications of that shift away from mechanical valves.
 
I don't know you and apparently you don't have a university degree.
That's not accurate.

You only criticize the duration of biological valves and try to convince people to choose mechanical valves.
Again this is false. If a young person asks for input on valve choice, Pellicle is likely going to point to the guidelines, which are evidence based. I've seen him suggest biological valves to members many times.

I'm going to believe them and the doctors and not you
There is nothing wrong with trusting your doctor over someone on the internet. In fact, that is exactly what you should do.

People choose the valve that works for them and it is their choice alone. Pros and cons for each choice. You indicated in your introduction thread that you have general anxiety and believed that the clicking would not be good for your mental health. Fine, you made your choice. There is nothing wrong with you making the choice you did. You are the only one who has to live with the ticking of a mechanicl valve and you are the only one who will need to go through a future procedure. We should all make the choice that works for us.

Science and evidence cannot be denied,
And yet you've provided no science to back up your claim that a 40 year old should expect 15 to 20 years from a tissue valve. Pellicle provided a study suggesting otherwise. If you have a study supporting your claim, then please provide it, as it will benefit others to know about this. I am almost certain that there is no such study, but I would be very happy to be wrong about this.

Also, it is fine to share what your surgeon told you to expect from your valve. I hope that he's correct. But, there are often hundreds of people who read these threads, most of whom do not even participate. Do expect to be asked for scientific data to support a claim, especially if one is claiming to have Science on their side in making said claim. It is for the benefit of many readers that we ask for data to back up such claims. At age 52 I had a surgical consult with the head of cardio thoracic surgery at Cedar Sinai and also the head of surgery at UCLA. I was told by both to expect about 10 years for a tissue valve, given my age. Young patients go through valves much more rapidly than do the elderly. If there is a new study suggesting otherwise, it would be good to know about it.

From the study linked by Pellicle:

"As a consequence of a more prominent immune response and increased valve calcification in younger patients, most bioprosthetic valves do not reach their average lifespan of 15 years as they do in older patients, with most deteriorating within a decade, especially for patients under the age of 65 [4]"

Anecdotally, this is also what we have seen on this forum, with young patients often coming back for their next operation after 6 to 12 years. There are exceptions, and I certainly hope that you are one of them. I hope you get 20+ out of your valve. That is not impossible. But, from the data which I've seen published in the medical journals, from my surgical consults, and from dozens of anecdotal stories on this forum, I am not of the view that a young patient should expect this. Hope for it?- Absolutely.
 
Last edited:
, I will tell you one thing: If the valve lasts me 1 year, I will be happy that year, I prefer quality to quantity of life.
Why do I sense some "buyer's remorse" in your post? You made the decision!

BTW, as far as quality of life is concerned.....I've had a very good quality of life for 57+ years, not 1 with my ancient mechanical valve.
 
Why do I sense some "buyer's remorse" in your post? You made the decision!
it was that which gave me pause to even say anything ... I see no reason to "rip the rug" on anyone. Its vexing but generally I prefer to only provide input on decisions before the decision is made. After that I will never point to someone and say "told you so". I will however, in discussion with someone who is deciding, use examples of people picking a valve that "science" would suggest would return about 10 years, who was promised (ambitiously) by someone that it would get 20 then if it ever failed would be a candidate for TAVR (who then wasn't).

To me as an adult I want to make informed decisions, not fanciful hopeful decisions. My whole premise since my time in school was "minimal distortion of reality".

Best Wishes
 
I'm sorry, I don't believe you at all. I don't believe you're almost 90 years old and you're writing here 24 hours a day. I don't believe your mechanical valve is 56 years old.
Do you have any way of proving that what you say is not a lie? Maybe you should be in the medical literature... Or in the Guinness Book...

Pretty long con, since I've been reading Dick's posts for more than 15 years now. :rolleyes: Retracting statements like this is always an option. But whatever, dude.

You could put "Bentall surgery" or "Medtronic Freestyle Root Bioprosthesis" into the forum search bar to get the user testimonials you are seeking. But why even look for testimonials when you've already had surgery? Your decision is made. What will be will be at this point.

Do your scheduled follow-up tests and enjoy your life.
 
@Timmay Another guy from the "mechanical valve sect". I'm not interested in your opinion at all, in fact I haven't read everything you've written, I'm not here to put up with traumatized people. You don't contribute anything here either. Science and evidence cannot be denied, the increase in biological valves in young patients is a worldwide fact. Good luck with your anticoagulants and your eternal noise.
Use has increased because of fear or not wanting to take a medication. Just know that quite a few who choose tissue valves for the lack of anti-coagulation end up on the anti-coag meds. You could get atrial fibrillation and end up getting prescribed Warfarin anyway. At your age the only thing guaranteed by getting a biological valve is another surgery, maybe two more. Not to mention, you state you would rather have 1 year of quality over quantity. 3-6 months of anti-coagulation meds is the standard after receiving a biological valve. So you could be on those meds for half that time anyway. Bleeding risks are there with mechanical valves, but the actual numbers are low. My main reason for going with a mechanical valve next week is that I know what open heart surgery is like, TAVR is never guaranteed to anyone, and I would rather go with the lower risk of re-operation.

The valve you choose for yourself is a very personal decision. Only you know what is right for you. But don't come here and get offended when you ask for information and it is given to you. You don't agree with what they say, or just don't want to hear it, ignore it.
 
I'm sorry, I don't believe you at all. I don't believe you're almost 90 years old and you're writing here 24 hours a day. I don't believe your mechanical valve is 56 years old.
Do you have any way of proving that what you say is not a lie? Maybe you should be in the medical literature... Or in the Guinness Book...


I don't believe you at all....I don't care!
My birth yr.... 1936
My valve was implanted.....Aug. 1967. s/n 178-UNK. Contact Edwards Lifesciences for additional info.
Looked into Guinness several years ago. Their charge to validate record date was $800. Not worth it.
I've posted on this Forum since 2007 (17 years with the same story). I would have to be one hell-uv-a liar to pull that off.

 
@dick0236 I'm sorry, I don't believe you at all. I don't believe you're almost 90 years old and you're writing here 24 hours a day. I don't believe your mechanical valve is 56 years old.
wow ... so you're accusing dick of perpetrating a lie here since 2007 ...

1728434923779.png


Do we diverge into mental illness here .... or is this backed by "the science"

1728435047964.png

(a science paper by Peter A Kirby_)

Dude, at the very least you owe Dick an apology ...

1728435108902.png

FMD
 
Use has increased because of fear or not wanting to take a medication. Just know that quite a few who choose tissue valves for the lack of anti-coagulation end up on the anti-coag meds. You could get atrial fibrillation and end up getting prescribed Warfarin anyway.
a good point ...

I've edited this down from an editorial remark about the Edinburgh study (attached)

Edinburgh Study editorial
REOPERATION
What is clear is the increased requirement for reoperation in patients
implanted with bioprostheses.
Overall, 21% of the patients required reoperation during the follow up period,
but around four times more reoperations were performed in the bioprosthetic group
compared to the mechanical group.
The present study rightly draws attention to the not inconsiderable risks of
reoperation (15% at 30 days and 22% at one year following operation).
These data are consistent with the mortality rates following reoperation reported
in the UKHVR. Although much lower mortality rates for reoperative valve surgery
have been reported,5 6 overall experience with reoperative valve replacement
still indicates that this is a relatively high risk procedure, and should not be
undertaken lightly.
HAEMORRHAGE
The data from the current study would immediately confirm this perception;
particularly at 10 years postimplant
all bleeding episodes:
* 15% mechanical
* 7.5% bioprosthetic for
all major bleeding episodes
* 12% mechanical
* 5% bioprosthetic ).
The situation changes by 20 years, however, with a relative increase in the bioprosthetic group incidence of all major bleeding episodes.
One important factor to be taken into account, however, is the progressive increase in anticoagulant treatment in the bioprosthetic valve patient group with the passage of time:
at five years postoperatively,
15% of aortic
36% of mitral
bioprosthetic implantees were being treated with warfarin. By 15 years, the numbers had doubled.
If the decision is replacement rather than repair, the latest
results from the UKHVR,4 prospective since 1986, for
patients having mechanical valve replacements (n = 46 810)
compared to bioprosthetic implants (n = 25 977) report
survival at 15 years postoperation for
* mechanical valve patients of 47.4% (95% CI 46.3% to 48.6%)
* bioprosthetic valve patients of 30.3% (95% CI 29.0% to 31.6%).
This difference is at least partially explained by patient age at
the time of implant.
For those patients aged 70 years and over, the survival rates at 15 years
postimplant are virtually identical
* mechanical 20.2%, 95% CI 16.5% to 24.1%,
* bioprosthetic 16.6%, 95% CI 14.3% to 19.0%).


The study itself is here (should verify that my PDF is not fabricated link) and as you can see it shows data from very old valves

The Edinburgh heart valve study of 533 patients, who had their valve implant(s) between 1975 and 1979, now reports comparative clinical outcome for mechanical versus bioprosthetic valves at 20 years.1 The present report supplements a 12 year follow up, published in 1991.2 The original study was prospective and randomised. The study design was modified in January 1977 in those patients randomised to receive a porcine bioprosthesis. Initially, the porcine valve used was the Hancock prosthesis, but, after January 1977, the Carpentier-Edwards valve was used because of its “substantial cost advantage”.


While on the subject:
d teapotimus quoted a study


valve but I recalled reading an interesting propensity matched study a while back that you may find helpful.

https://www.jtcvs.org/article/S0022-5223(17)31896-2/fulltext


which contained the following results
After bioprosthetic valve replacement (at 15 years versus mechanical valve replacement)
  • stroke rates were lower 5.4% [95% CI, 3.8%-7.2%] vs 8.1% [95% CI, 6.3%-10.2%], HR 0.62 [95% CI 0.43-0.91]
  • bleeding rates were lower 4.2% [95% CI, 3.0-5.6%] vs 8.4% [95% CI, 6.6-10.4%], HR 0.48 [95% CI, 0.33-0.69],
but reoperation rates were greater
  • 24.5% [95% CI, 21.3%-27.8%] vs 9.3% [95% CI, 7.2%-11.7%],
    HR 5.9 [95% CI 3.2-11.0])
For those unfamiliar with how to properly interpret Hazard Ratios from:

1728437123128.png

https://www.jto.org/article/S1556-0864(15)32030-X/fulltext


1728437123157.png


suggesting that both of the statistics on the stroke and the bleed rates (0.62 & 0.48 respectively) are below the threshold where one would really say they make much difference.

However the HR 5.9 for reoperation is well above 1.25

So basically he's just provided the data that makes the point in favor of mechanical if you expect to live more than 15 years.

What isn't mentioned is at 15 years how many of the bioprosthesis patients went on to needing ACT; which may elevated their rates of bleeds ... or didn't go on to ACT and that may have elevated their rates of strokes (where they didn't have reoperation before the 15 years but needed to go on to the very hing they sought to avoid... warfarin)

Also I'll take the red curve from that study thanks ...

fx1_lrg.jpg




Again, from that article

Discussion​


... Our study indicates that aortic prosthesis choice appears to have minimal impact on survival at 15 years and suggests that bioprosthetic aortic valve replacement, which was associated with a lower risk of stroke and major bleeding, is a reasonable alternative to aortic mechanical valve replacement for adult patients younger than 50 years of age.

The primary benefit of mechanical over bioprosthetic aortic valve replacement in our analysis was the almost 60% reduction in reoperation at 15 years

Oh, is that all only a 60% reduction

Not a bad analysis for a guy without a high school education who taught himself to read (well, a couple of other languages if not English).
 

Attachments

  • edinburgh study.pdf
    83.7 KB
You know Wendel, if you hadn't said these things

It's really pathetic to read some lunatics discrediting this forum.

@dick0236 I'm sorry, I don't believe you at all. I don't believe you're almost 90 years old and you're writing here 24 hours a day. I don't believe your mechanical valve is 56 years old.
Were it not for the replies to that, I would not have even known there was any reason to rejoin the conversation...

in fact I haven't read everything you've written, I'm not here to put up with traumatized people. You don't contribute anything here either.

so you say that you haven't read anything @Timmay has written and he's contributed nothing here either (I assume to the testimonials of the survivors, which it was pointed out you could have just searched for), well that's a sad thing.

I suspect that the actually traumatised person is you, which you are in denial of, which is why it bothers you. I strongly recommend that you go get some professional help with that and stop just making slanderous accusations about members here.

So lets look at studies (you know, science).

Long-term clinical outcomes 15 years after aortic valve replacement with the Freestyle stentless aortic bioprosthesis

doi: 10.1016/j.athoracsur.2013.08.047. Epub 2013 Oct 17.
Ann Thorac Surg - 2014 Feb;97(2):544-51.

Background: The Freestyle stentless aortic root bioprosthesis has excellent hemodynamics and durability through 10 years. The purpose of this report is to present clinical outcomes in a large multicenter cohort through 15 years.​

Seems pretty reasonable (underline mine).

Methods: The multicenter evaluation of the Freestyle valve began in 1992 at 21 centers in North America and Europe. In 1997, a long-term study continued, including 725 patients from 8 of the original centers; clinical outcomes data after 10 years have continued to be collected at 6 of 8 centers.​

so we have some collected data from about 75% of their sources

Patient age was 71.7±7.9 years.​

so not young ... oldest was nearly 80 youngest around 63 ... at 40 you'd need to have the valve last 20 years before you began applying this data.
Also at that time life expectancy was about 80 years. So the average patient in that only has to go 9 years to be high probability of being dead


There were 402 (55.4%) men and 323 (44.6%) women.​

noted ... I'll come back to that.

There were 52 late reoperations, with explant of the bioprosthesis in 47 cases.​

myself I'd like to know what those explant reasons were and what qualifies as late, it is after all about 11% of the (rather elderly) cohort.

Respective 10- and 15-year survival was 46.2%±2.3% and 25.9%±3.2%;​

which is not surprising given the age group even if they didn't have a valve ...

freedom from valve-related death was 94.9%±1.5% and 92.7%±3.5%;​

suggesting that most died of other co-morbidies (if not just normal age related issues)

freedom from reoperation was 92.3%±1.8% and 80.7%±5.0%;​

so if you didn't die and therefore required a reoperation we have 93% A-OK at 10 years this figure (7% reoperation rate) isn't far away from the late 1970's valves in the Edinburgh study (where reoperation was 8% at 5 years and 37% at 12 years), but its vexing because we don't know what these reasons are except to say they may not be SVD

and freedom from explant owing to structural valve deterioration was 96.5%±1.3% and 83.3%±4.8%.​

its nice that they clarify the percentage who required reoperation due to SVD 83.3%±4.8% which is about 21.5% ~ 11.9% As we do not know what the reasons for reoperation in the Edinburgh study (some like here may have been SVD.

Do we add these or is one a subset of the other. Hard to know, but not "light years better"
Increased age was associated with higher risks of all-cause mortality and valve-related mortality and lower risks of reoperation and explant caused by structural valve deterioration.​

So even they acknowledge that SVD is a lower risk of driving a redo surgery because the cohort is old ... not 40

Anyway, it isn't important what happens to others, its only important what happens do you. I hope you get a good run out of your valve and I hope that when reoperations time arrives you'll have worked through your trauma and are in a better state to make a decision for OHS #2 (which precluding your unfortunate early death is as certain as taxes).

As I've said before, picking a bioprosthesis for a first surgery to get you into a different phase of life where you can perhaps accept ongoing ACT is not a bad thing. I myself had a OHS at 28 (my second) which was a homograft and got a good life out of that without ACT. It was only on my 3rd OHS that I picked mechanical, and happily management of ACT had certainly improved.

Best Wishes
 
I only asked for people's opinions, it's incredible how these people DO NOT RESPECT, they flood the posts and no moderator says anything to them. I understand that this forum charges a membership and generates money from people with mechanical valves.
But the mechanism they use to generate money is very unfair and inhuman. People with biological valves don't go around traumatized on internet forums, they live their lives.

They copy information that is 10 or 20 years old from PUBMED and think they are doctors (it's regrettable).
Here they believe themselves to be immortal, and they even speculate about how long they will live, "my valve will last 30 years, so I will live 30 years." It's always the same traumatized people writing the same things. I will start to make my time count, because I do have a long life ahead of me.
 
Back
Top