41m, AVR, Aneurysm Graft, new to site!

[Buck83]

I think given that

a) your valve wasnt bicuspid - so your condition is not congenital (meaning you were not born with it)
b) Your physicals never detected a heart murmur and you had them annually
c) You got sick while on duty

How can they disagree with the idea that this happened as part of your job? By the way, some doctors think that excessive stress plays a role in aneurysms. Point is there are many factors behind aneurysms. Some could be work related.

So I hope that your appeal works. It is frankly ridicoulos that given the facts above they ruled against you.

I am so sorry about all this for you and I hope that they will see sense during the appeal.

I think given that

a) your valve wasnt bicuspid - so your condition is not congenital (meaning you were not born with it)
b) Your physicals never detected a heart murmur and you had them annually
c) You got sick while on duty

How can they disagree with the idea that this happened as part of your job? By the way, some doctors think that excessive stress plays a role in aneurysms. Point is there are many factors behind aneurysms. Some could be work related.

So I hope that your appeal works. It is frankly ridicoulos that given the facts above they ruled against you.

I am so sorry about all this for you and I hope that they will see sense during the appeal.

Thank you so much for the support and encouragement. My valve was deemed congenital bicuspid though. I just never had any issues and never knew it.

 

[Buck83]

The trial which allowed Cryolife to get the FDA to accept the lower INR range for the On-X was known as The PROACT Trial. The publication linked below contains data from the PROACT Trial. There were only 375 patients studied in the trial, with about half going to the the lower INR range of 1.5 to 2.0 and the other half, the control group, getting the range of 2.0 to 3.0. There ended up being significantly more TE and Thrombosis events in the 1.5 to 2.0 INR test group; 2.96/patient year vs 1.85/patient year in the control group. See link to Table 1 from the study linked below. That represents a 60% increase in events. Yes, the lower INR group had fewer bleeds, but many are of the opinion that they would rather have a bleeding event than a stroke.

Table 1

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6472691/table/table-1/?report=objectonly

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6472691/

Edit:
I came across this publication which was from a presentation of the interim results for the the PROACT Trial and wanted to add it to the above as it includes some additional data which I find interesting. See link below.

Some findings which I find noteworthy:

"No difference was noted between the low-dose and standard therapy arms at 1.6 years of follow-up, including mortality (2.1%/patient-year [PY] vs. 1.3%/PY, p = 0.45), major bleed (2.8%/PY vs. 4.2%/PY, p = 0.36), minor bleed (3.1%/PY vs. 4.8%/PY, p = 0.3), stroke (1.4%/PY vs. 0.3%/PY, p = 0.16), peripheral thromboembolic event (0.69%/PY vs. 0.32%/PY, p = 0.52), thrombosis (0% in both arms), or a major event, defined as major bleed, stroke, or thrombosis (4.2%/PY vs. 4.5%/PY, p = 0.84)."

They use the term "No difference" but there were, in fact, several differences. I believe that the proper phrasing would be to say: "The differences did not reach statistical significance." This is often the case when a study is under powered with low patient enrollment, and the enrollment was relatively low for PROACT.

One can only wonder if these differences would have reached statistical significance if the study had a higher power with more enrollees:

Mortality (2.1%/patient-year [PY] vs. 1.3%/PY, p = 0.45) This represents a 62% increase in mortality for the low INR group.

Stroke (1.4%/PY vs. 0.3%/PY, p = 0.16) This represents a 467% increase in strokes in the low INR group.

Peripheral thromboembolic event (0.69%/PY vs. 0.32%/PY, p = 0.52 This represents a 216% increase in the low INR group.

Major bleed (2.8%/PY vs. 4.2%/PY, p = 0.36) The low INR group had 33% fewer major bleeds.

Of all of these, the one which I pay the most attention to is mortality. I find a 62% increase in mortality very noteworthy, even if the p value did not reach statistical significance. Was the strategy to keep the enrollment sufficiently low in order to be able to say "No difference in mortality"?
Interesting that the FDA gave approval, given there were so few enrollees. In my view, there is good reason for the controversy over PROACT, as well as the decision to allow for the lower INR range by the FDA. I would also be very interested to know how many of the strokes and other clotting events left the patients with permanent damage.

https://www.acc.org/Latest-in-Cardiology/Clinical-Trials/2014/04/17/21/22/PROACT

Wow. That was not the information I was given. That blows me away. How could the FDA approve that? Big pharma always looking out for us!

 

[3mm]

I had an On-X aortic valve installed Sep 14, 2023. My INR was very stable around 2.0-2.6 from early Nov until Jan. Then I got Pneumonia, and my INR dropped to 1.5. I was VERY GLAD I had been keeping my INR above 2.0 before the Pneumonia struck.

Buck83 - You may do very well in the civilian job market. For example, I was an aerospace engineer at the Collins Aerospace division of Raytheon. We had some ex-military people who had been pilots, worked in aviation maintenance units, etc. They fit in well since many of our customers were military. I well remember a Vietnam vet from an artillery unit. As an engineer, he truly understood the idea that the calculations must be correct!

 

[pellicle]

That blows me away. How could the FDA approve that?

you'll find this topic commonly discussed here ... I frankly don't know how the On-X valve gets it rep, but the marketing people are zingers.

Something else about "claims" which evidence does not back:
https://www.valvereplacement.org/threads/aortic-valve-choices.887840/page-2#post-902334

examine the table and compare measurements of specifications, with claims of specification (compare St Jude with On-X).

Myself I have an ATS (also in that chart) but at no time did I discuss that aspect with my surgeon. I don't actually think its important. However the point of the matter is if a (let say...) Car maker claimed X for their specs and an engineering pull down revealed less than X they'd get sued.

Not in "ValveLand"

there is two phrases I like to return to

• caveat emptor
• due dilligence

when "being informed"

Best Wishes

 

[pellicle]

also @Buck83

"No difference in mortality"?

in an "summary essay" I tapped up (to save me typing the same thing again, and again): https://docs.google.com/document/d/13Ql9hSmHDlouFKrgEcpIxu1GZov1z-xhI2OXFEnQe7Y/edit

I write: The mean follow-up was 3.8 years and was 98% complete {so not very long} The mean INR was 1.89 in the test group and 2.5 in the control group (p < 0.001).{so about what we target as the bottom end or }

now according to this study, we see this data for INR and valves

in the "1.5-1.9" group the incidence per 100 patient years is 26.6 which is amusingly similar to low chance of seeing an event in 4 years ... however step that out to 5 years and its better than 50:50

Makes you wonder about their choice of "low" even more ... because I'm sure they know that too.

Best Wishes

 

[Buck83]

Wish I had found you guys 2 years ago! Probably would’ve saved me a stroke!

 

[pellicle]

Better late than never,

Probably would’ve saved me a stroke!

and I sincerely hope you never have another

 

[pekster11]

you'll find this topic commonly discussed here ... I frankly don't know how the On-X valve gets it rep, but the marketing people are zingers.

Something else about "claims" which evidence does not back:
https://www.valvereplacement.org/threads/aortic-valve-choices.887840/page-2#post-902334

examine the table and compare measurements of specifications, with claims of specification (compare St Jude with On-X).

Myself I have an ATS (also in that chart) but at no time did I discuss that aspect with my surgeon. I don't actually think its important. However the point of the matter is if a (let say...) Car maker claimed X for their specs and an engineering pull down revealed less than X they'd get sued.

Not in "ValveLand"
View attachment 890110

there is two phrases I like to return to

• caveat emptor
• due dilligence

when "being informed"

Best Wishes

On-X seems to have market penetration waaaay better than the other valve manufacturers
So many people seem to believe it is a superior valve
I agree their Marketing department is very good !

 

[Chuck C]

On-X seems to have market penetration waaaay better than the other valve manufacturers
So many people seem to believe it is a superior valve
I agree their Marketing department is very good !

Yes, Cryolife owns the On-X patent and they have aggressive marketing. In addition to the On-X valve, they also have a financial interest in promoting the Ross Procedure, as they provide the cryopreserved pulmonary valves used in the Ross. Like the On-X, they promote the Ross very aggressively. I will let others judge as to the ethics of such aggressive marketing.

 

[vitdoc]

Wow. That was not the information I was given. That blows me away. How could the FDA approve that? Big pharma always looking out for us!

The company concocted a new variable where they basically added the risk of an embolic process to the risk in bleeding. Using this statistic they found no statistical difference between the different INR regimen. So If you rather have a stroke than a bleed go for the low INR approach. I think the majority of sane people would prefer not to have a stroke.
How this passed the FDA approval is beyond me. I think it should be revisited by the FDA especially now that there should be a lot of post implantation data.
Marketing in medicine is very big and physicians like others can be swayed. The marketing can be very subtle and the physician would testify to being unbiased if asked. But the reality is that the marketing does have an effect otherwise it would not be so heavily done.

 

[Chuck C]

Marketing in medicine is very big and physicians like others can be swayed.

I really appreciate you pointing this out Vitdoc. Coming from a surgeon this statement carries a lot of weight. This fact might seem obvious, but it seems that many patients fail to realize this truth. In the US especially, the marketing in medicine is enormous. There is marketing directed to patients, but there is also an avalanche of marketing that is directed towards physicians.

 

[pellicle]

So If you rather have a stroke than a bleed go for the low INR approach. I think the majority of sane people would prefer not to have a stroke.

The old phrase from here

"It's easier to replace blood cells than brain cells"