3 potential choices

[jag004]

I'm 48, had OHS AVR and aneurysm repair in 2013. 11 years later and my Edwards Bovine is severely regurgitating. Time for surgery.



Had a quick 1st talk of many with the surgeon who gave me 3 possible options:

A) St Jude mechanical valve, which he uses most and pitched the hardest.

B) On-X mechanical valve, which he said he also uses often, but patients complain of loud ticking.

C) TAVR with a tissue valve, which he said would only last 3-4 years for me, and he was against for my case.
This was told to be an impossibility for me until I met the surgeon yesterday.


Dr also stated the risk of stroke only goes up .33% each year with mechanical St Jude, on a big study that he uses as a standard.

1 year = .33%
2 years = .66%
3 years = 1.00%
4 years = 1.33%
etc, etc, etc


I am going to do my own research and own searching around on this forum for information. But, if anyone can chime in with an opinion I would greatly appreciate it ......good or bad.

Thank you

 

[dick0236]

You have been on this forum since 2013 so you should have a pretty good knowledge of valves. I'd go with the St. Jude. It has a long successful track record and a reasonable INR maintenance program. IMO Onyx is promoted too much around their super low INR plan of around 1.5. INR's that low leave almost no margin for error.

Stroke risk with a mechanical valve is about 1% each year altho it probably does go up some as we become elderly. I had my one and only stroke seven years post-op which was due to my ignorance and mismanagement of warfarin. The lack of proper INR management is what causes most strokes according to health professionals I have talked with over my years on warfarin. Taking the drug as prescribed and testing regularly (one to two weeks) removes the greatest risk of stroke. The introduction of "home INR testing" is proving to be a significant help in reducing stroke.....and bleeding issues.

 

[dornole]

Def mechanical, tavr would arguably be close to malpractice at your age

 

[3mm]

On-X mechanical valve, which he said he also uses often, but patients complain of loud ticking

I must sit in a silent room and listen carefully to hear my On-X aortic valve. It is not an issue for me.

Onyx is promoted too much around their super low INR plan of around 1.5

I target an INR of 2.5, and I consider the "super low INR" as an extra safety margin. I need to ask the Mayo Clinic why they gave me an On-X valve and not a St. Jude valve....

 

[pellicle]

Good morning

I'm 48, had OHS AVR and aneurysm repair in 2013. 11 years later and my Edwards Bovine is severely regurgitating. Time for surgery.

I see you haven't made many posts since then so I suspect that you may not have kept up but instead gone blue pill an doubled down on your good choice in your 30's to have had a bovine ... I'm sorry about that.

As you will know if you read any of my replies I'm a strong advocate of a mechanical valve choice.

So let me address your questions in a different order

C) TAVR with a tissue valve, which he said would only last 3-4 years for me, and he was against for my case.
This was told to be an impossibility for me until I met the surgeon yesterday.

its up to you, but

1. there are reasons why its designated for high risk patients (note, high risk means high risk of death due to surgery)
2. the surgeon you spoke with was either brain washed, dishonest or you pushed that line (I can't know which)

So please, do take the time to read this:

Almost 50% of Patients Under 60 Years Choose TAVR Over SAVR with Worse Outcomes​

https://www.sts.org/press-releases/...60-years-choose-tavr-over-savr-worse-outcomes

From a pool of 37,011 patients, the study identified 2,360 patients under the age of 60 years who underwent these procedures with 22% receiving TAVR and 78% SAVR. By 2021 almost half of patients younger than 60 years were receiving TAVR rather than SAVR. The research team followed these patients for a median time of 2.4 years after TAVR and 4.9 years after SAVR to assess their outcomes.​

​

The primary focus was on 5-year survival rates. Secondary outcomes included rates of reoperation, infective endocarditis, stroke, and hospital admissions for heart failure. Propensity score matching ensured a fair comparison of 358 pairs of patients, balancing factors such as age, major health conditions, hospital volume, and urgency.​

​

While the 30-day mortality rates were similar (0.2% for SAVR vs. 0.4% for TAVR), the 5-year survival rate was significantly better after surgery compared to TAVR (98% vs. 86%, p < 0.001). For secondary outcomes, there was no significant difference between the two groups.​

​

“While we expected that the volume of transcatheter therapy would increase over the study period in this young patient cohort, we were surprised there appears to be near equipoise in terms of procedure selection, with patients and clinicians opting for procedures against the 2020 guidelines,” said study coauthor Jad Malas, MD, a cardiothoracic surgery resident at Cedars-Sinai Medical Center in Los Angeles.​

sounds real appealing to me ...

not

B) On-X mechanical valve, which he said he also uses often, but patients complain of loud ticking.

I would never recommend an On-X but would not go as far as to disparage it.

1. its a copy of the St Jude (as are many) but offers nothing more than marketing promises and failure to live up to any measurable expectation of its promises. Please read this post.
2. Its rather larger and I don't see why nor is there anything it states to excuse it except possibly it has something to do with the Pannus Guard feature. However IMO that's like marketing everyone to wear a full face motorcycle helment while driving a car because its safer. It is, but with motor vehicle accident rate is down to the lowest per 100,000 its been since the 60's
   
3. everyone complains about the ticking ... (*everyone means the vocal minority, like everyone in the USA thinks "insert here")

A) St Jude mechanical valve, which he uses most and pitched the hardest.

I have an ATS, but that would be my pick right now.

Dr also stated the risk of stroke only goes up .33% each year with mechanical St Jude, on a big study that he uses as a standard.

people plain and simple in the main just don't get statistics. I apologise if you are a Statistical Maths Major (in your Maths Degree) but plain and simple its like this:

• it depends entirely on maintaining your INR in the range
• just like a coin flip the results are not cumulative (unless you do not maintain your INR range even half heartedly), even though its 50:50 you won't get a head because you flipped a tail. .

learn how to maintain your INR and you'll be in the green group:

I am going to do my own research and own searching around on this forum for information.

Please do make sure its actual research (involving critical thinking) and not the usual "support my pre-established bias guided readings"

https://cjeastwd.blogspot.com/2021/07/done-my-research.html

I'd start here:
as previously suggested by Dr Schaff of the Mayo


more current video


and perhaps this
https://www.medscape.com/viewarticle/838221

I would recommend you stop reading right now, get cup of coffee, a pen and paper, make notes while watching and listening


Best Wishes

 

[pellicle]

I need to ask the Mayo Clinic why they gave me an On-X valve and not a St. Jude valve....

I'll personally be real interested in that answer.

I'll say though that if you canvas Surgeon's at a conference you'll get a division of preference. I'd venture that division will be split around

• proven track record (that'd be St Jude)
• want to see where the On-X goes (= FOMO)

Myself I'm glad I got what I got.

 

[pellicle]

oh, and @jag004
just wanted to follow up that I'd read through your previous posts here and so have some recollection of what you were concerned about before. However what I wanted to add is this:

In Japan they use the word Sensei ... its often mistranslated )by dopes who don't grok the culture) that it means "elder" not teacher. The traditional Japanese view was that if you had lived before me then you could have experience I can learn from.

previous is wrong it more properly means preceding

So I can say that when I was about ten (in about 1974) I had my first OHS, this gave me (what is now called) a valve sparing surgery and a ton scar tissue and left over debris in my thoraccic cavity (modern surgery is perhaps better at the latter).

Then when I was 28 (and so, technology was not where it is today) I was given a choice (but it was pretty obvious) of a homograft or a mechanical. I chose the homograft and avoided warfarin therapy for a while. We had no idea how long that 'while' would be. I also got that scar tissue enhanced (making future surgeries more difficult).

Then in late 2011 I had a 3rd OHS where I would get even more scar tissue, and was advised I could pick anything I liked, but would be so high risk on my 3rd that "no good surgeons would be lining up behind me" to do that surgery (because they value their records).

I picked a mechanical.

I got an ATS ... of which I'm very glad. I was curious about the (then new) On-X but my surgeon leaned towards anything else but that. He is a conservative man who likes good odds.

I'm very glad that he picked the ATS and from that I began my part time career of learning about anticoagulation (because from there I was on it for life).

You can learn a lot if you put your mind to it over 12 years; heck my research masters was only 3.

よろしくお願いします (Yoroshiku Onegaishimasu)​

ne

 

[hevishot]

Dr. Patrick McCarthy, executive director of the Bluhm cardiovascular institute at Northwestern medicine in Chicago states: "The risk of stroke in patients with a mechanical valve is 3% per year."

 

[Chuck C]

Hi Jag004.

Had a quick 1st talk of many with the surgeon who gave me 3 possible options:

A) St Jude mechanical valve, which he uses most and pitched the hardest.

B) On-X mechanical valve, which he said he also uses often, but patients complain of loud ticking.

C) TAVR with a tissue valve, which he said would only last 3-4 years for me, and he was against for my case.
This was told to be an impossibility for me until I met the surgeon yesterday.

In my view, you're getting solid advice from your surgeon. His encouragement for you to get a mechanical valve is consistent with the guidelines for a patient your age. Also, I'm glad to hear that he was against TAVR for you. TAVR (aka TAVI), is much better suited for high risk patients. At your age you want a long term solution.

But, if anyone can chime in with an opinion I would greatly appreciate it ...

I agree with your surgeon that mechanical is the way to go. Also, given its excellent long term history, with published literature of well over 30 years, I think that it makes perfect sense for him to recommend the St Jude mechanical for you. My second consult with my surgeon was to narrow my choice down between St Jude and On-X. Like your surgeon, my surgeon strongly preferred the St Jude, given its long excellent track record, although he would have been happy to go with On-x if that was what I really wanted. Having said that, I do believe that the On-X is a good valve and has shown good outcomes also, as long as one sticks with an INR of over 2.0 and does not fall for the marketing scheme of INR of 1.5 to 2.0. Your surgeon appears to be on top of the literature, so I would be interested to hear his view on the 1.5 to 2.0 INR range for On-X. One thing that my surgeon said was that if I decided to go with On-x, that I would not be on INR of 1.5 to 2.0, but would be targeting INR of 2.5. He said that the low INR range for On-x was just marketing and put patients at greater risk for stroke.

Best of luck with the decision before you.

 

[vitdoc]

One of the big concerns when numbers are thrown around about stroke risks with mechanical valves is the method of checking the INR levels on warfarin. I would anticipate worse results with “standard” testing than with proper self testing. For the most part few studies require self testing. Even the results of a fib patients who are compared on warfarin vs novel anticoagulants such as Eliquist have not been done with self testing as a requirement. Why would the drug company want to risk not having their drug look as good as possible?
To me 3% stoke/year seems a bit high. But with mediocre testing maybe it is true.

 

[Chuck C]

I would anticipate worse results with “standard” testing than with proper self testing. For the most part few studies require self testing.

Good point. Weekly self monitoring INR has been shown to result in far fewer events. Do you know which trial actually used weekly home testing to monitor INR? The Proact Trial, testing the low INR range of 1.5- 2.0 for the On-X valve. I doubt this was by accident. The authors, sponsored by the valve manufacturer, clearly knew that this would result in fewer clotting events than a typical patient who is only tested every 4 to 8 weeks.
Yet, amazlingly the FDA approval protocal for the lower INR range does not require weekly self testing. In my view, this is an enormous oversight. The low INR test group was on 81mg of aspirin daily and self tested weekly. The FDA protocal does require 81mg of aspirin with the low INR range, but for some reason they neglected to include the other key detail, which was weekly self testing. As we've discussed here on the forum several times ,there are many other issues with the Proact Trial.

 

[pellicle]

Dr. Patrick McCarthy, executive director of the Bluhm cardiovascular institute at Northwestern medicine in Chicago states: "The risk of stroke in patients with a mechanical valve is 3% per year."

Given what I see with anticoagulation management I'm not surprised, well actually I'd sort of expect worse when you combine the miserable job many clinics do with poor patient adherence. People are unaccountably stupid on so many things and proper compliance with medications is certainly one of them.

So much so that always mention the importance of factoring this in on valve choice. Sadly there is no perfect choice but each choice brings with it its own type of side effects.

However on the bright side the risks you mention above are pretty much on the high side, and can easily be skewed to something like 2% (but not within a year) by just keeping inside your range. Its typically something like 2 ~ 3 events per 100 patient years.

Importantly these are not cumulative so it doesn't add up to 100% as soon as you'd think. So looking at that we can see how someone would say its 2%. With the 2 per 100 patient years its more like 50:50 that you'll have some sort of thrombosis event over 50 years.

Better yet, I know someone (and there are many) who have had a stroke, seen to it quickly and gone on to make a 100% recovery.

Best Wishes

 

[dick0236]

To me 3% stoke/year seems a bit high. But with mediocre testing maybe it is true.

I can remember that, not too long ago, the normal PT or INR testing was monthly for valve patients with a vein draw (very uncomfortable). I believe that is when Warfarin got such a bad reputation......getting stuck with a needle in the elbow was not fun. A lot can go wrong in a month......especially if the patient sloppily treats warfarin. I can also remember a time (late 70s-early 80s) when a doctor had me on a three month testing schedule because my pt/inr was was very stable. It was easy for patients and doctors to make mistakes during those "olden days". Nowdays, with the availability of info and professional INR labs ..........and self testing, the number of mistakes (stroke or internal bleeds) are not what they used to be.

I agree with 'vitdoc".....3% is too high unless the patient treats warfarin in a cavalier manner. Taking the pill as prescribed and testing regularly should greatly minimize the risk of stroke.

 

[pellicle]

but keep in mind the slight increase in stroke risk over time.

agreed, but don't just keep it in mind, do something about it ... make sure you test weekly and are >90% in therapeutic range. The statistics are based on more like 70%

I like to think of it like this: some people never use their rear vision mirror when they change lanes, just blindly doing what they want. If you come from a low traffic area you can get away with this more.

Same goes for texting while driving.

 

[pellicle]

I can remember that, not too long ago, the normal PT or INR testing was monthly for valve patients with a vein draw (very uncomfortable)

I just want to remind folks that Dick has a history of being on warfarin for approaching 60 years now. I'm only 12 years, so I can't ever remember a time when that was true (but I have read about it).

not to be flogging that dead horse more ...

 

[hevishot]

Yes numbers can be skewed. Is that for all numbers or just the ones you disagree with?

 

[Jeff Lebowski]

Stroke risk with a mechanical valve is about 1% each year altho it probably does go up some as we become elderly. I had my one and only stroke seven years post-op which was due to my ignorance and mismanagement of warfarin.

I'm asking because I don't know anything about this subject.
Is the risk of stroke still increasing by 1% every year even if we use warfarin and monitor inr properly?
Is it possible to treat this condition when you have a stroke?

 

[LondonAndy]

I'm asking because I don't know anything about this subject.
Is the risk of stroke still increasing by 1% every year even if we use warfarin and monitor inr properly?
Is it possible to treat this condition when you have a stroke?

This UK study, by our NHS "regulator" in 2013, would suggest the risk of a stroke is greatly reduced with self-testing [and I would go on to say self-managing, for those willing to do so].

 

[dick0236]

Yes numbers can be skewed. Is that for all numbers or just the ones you disagree with?

One of the first things I was taught in Accounting 101 was "Figures don't lie but liars figure"

 

[dick0236]

I'm asking because I don't know anything about this subject.
Is the risk of stroke still increasing by 1% every year even if we use warfarin and monitor inr properly?
Is it possible to treat this condition when you have a stroke?

The risk of stroke is not cumulative but it easy to see some increase as we age. Old age makes us vulnerable for a lot of stuff that we "blow off" when we are young.......been there, done that.

Proper warfarin management is pretty easy and, if it is done properly, will greatly reduce any problems of stroke or bleeding........but it can't eliminate the risk.......nor can anyone get 100% protection from stroke regardless of "native" or "artificial" heart valve.

Stroke, especially in the young, is normally survivable. However, the damage done by a stroke is very often permanent.......the visual disability I suffered due to my stroke in 1974 has never improved but I have learned to compensate for it and few people can recognize my problem.

PS: I am not a medical professional but I have been around the subject of heart valves, stroke survival and warfarin protocols a long time.........so, take what you need and leave the rest.