When Edwards' INSPIRIS RESILIA Valve will be market available in US?

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Paleowoman

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hx77;n880531 said:
Better to do second OHS in 15 years than in 5 years after first OHS. (I am thinking the other way around. Could someone explain to me the logic?)...<snip>...Could someone comments on the risk of second OHS? Specifically is it riskier to do it early vs late?
Hi hx77 John - I can give a comment on this because I have been seeing a cardiac surgeon (seen two over the past few months actualy) since I had my bicuspid aortic valve replaced just under four years ago. Because of the small size of my replacement valve I have "moderate patient prothestesis mismatch", which has resulted in me developing some symptoms and never getting back to how fit and well I was prior to surgery. The question of doing redo surgery to do various things to put in a bigger valve at this point in time has been discussed. Both surgeons have said that to do so now would carry a high risk of mortaility, particularly due to scar tissue I understand. I don't think that the mortality risk gets less leaving it, I think the mortality risk might get greater due to increasing age, but they would wait until the risk of not doing redo surgery is greater than the risk of doing it.

PS the new generation of Inspiris Resilia valve should last as long as a mech valve so more than 15 years (your last paragraph above) - that's why in the UK they have inserted that one in a patient in her 20s and another in her 40s and they expect the valve to last. Of course only time will tell but that's how it is being marketed by Edwards.
 
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pellicle

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cooked (drank the wine, on my second beer now)



ultimately if you regularly eat so many kg of high Vit K foods a day then just adjust the dose of warfarin to give you a INR of your target and then if for some reason you "go off" eating so much then your INR will only trend a little high.

Measure and know thyself
 

hx77

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Hi Pell, thanks for the picture illustrations. I do not weigh my food yet but I might do that if I have to control VitK intake. I eat cooked vegetable and I could easily finish a bowel of cooked green vegetable every day. So I eat much more vegetable than you do no pun intended). My son's friend was told by his cardiologists to reduce green vegetables. I do not know his ACT regime.

Hi Ann, many thanks for the explanations which make a lot senses to me. Different doctors might have different opinions of the new valves. BTW, my surgeon was involved with the clinical trial of INSPIRIS. I hope you will find a good solution to your issue and have a quick recovery.

Regarding whether I should postpone the AVR, two cardiologists and one surgeon I spoke with all thought I should piggyback AVR on CABG. My family except me all think I should do AVR now too. But on the other hand, even my surgeon thought there could be at least five year life of my AV and who knows it won't be longer (the leaflets are only mildly calcified and AVA is stable). It is hard to be a contrarian.
 

hx77

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"eat healthy ... it'll save your life."

Pell, I do not consider sausage healthy. It is processed food with a lot of saturated fat and cholesterol. I would stay away from it. Best, John
 

dick0236

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Dealing with warfarin is very simple........"dose your diet, don't diet your dose". My own experience is the amount of vit K in food does not affect my INR in any significant way.....and removing these vit K foods would make my life boring:Tongue:. Everything good in life is "illegal, immoral or just plain not good for U".....so live a little.
 

pellicle

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hx77;n880542 said:
"eat healthy ... it'll save your life."

Pell, I do not consider sausage healthy.
Its a different sausage to what you'll find in America, I am in Australia after all. It is mostly minced pork. Meat, in chunks. I guess the salad is processed too much too...

But thanks for ignoring everything ive been saying.

I know it's hard coming from listening to doctors go on about warfarin and its dangers. Prople who arent on it, dont manage it i, are not deeply involved in lesrning about it (because it's not them).

Why take the opinions of actual people with years of personal experience.

We are all wrong ... Right?

My mistake was probably in assuming you were asking me questions to genuinely learn. Rather than to defeat me in debate.
 

hx77

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It is simple. I have CAD. I need to eat more green vegetable to prevent calcification of my arteries and heart tissues.
 

pellicle

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hx77;n880549 said:
It is simple. I have CAD. I need to eat more green vegetable to prevent calcification of my arteries and heart tissues.
Its indeed simple, I don't.

So dont judge my diet please.

Thr point remains rvrn if you eat spinach as every meal, then you srill just measure INR and determine a dose ... Warfarin is simple to manage if the manager just ibserves that
  1. Dose is determined only by INR outcomes
  2. Measurements are needed
The literature is clear on this (even if doctors aren't)
 

pellicle

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hx77;n880549 said:
It is simple. I have CAD. I need to eat more green vegetable to prevent calcification of my arteries and heart tissues.
Let me restate: I don't care what valve you pick.

I had assumed you were discussing this to learn about warfarin, which you have a great many misconceptions about.

Clearly you aren't interested in that and I don't come here to attempt to evangelize for anything other than helping people get knowledge.

Simple.
 

Agian

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I take Vitamin K2 supplements. I'm on Warfarin.
Eat as many green veggies as you feel you need to.
if you have a bowl of spinach every day, your dose and inr will be stable.
Make it part of your routine and kill two birds with one stone.
 

epstns

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hx77 - To try to answer one of your earlier questions, the reason the docs recommend the combined AVR and CABG procedure is so that they can reduce your overall risk of cardiovascular events in the next few years. Stenotic valves are known to be unpredictable, and we have found that "the worse they get, the faster they get worse." The progression is not linear. It picks up speed as your valve goes "downhill."

The other reason they say fix it all now, then worry about it again in 5 years is that they plan that there will be much better tools and techniques available for your next replacement in 15 years than we have now or will have in 5 years. They know what time they can "buy" you now, and they don't expect it to materially change in 5 years, but they anticipate major changes in the longer 15-year horizon.

Also, the risk level for the combined AVR/CABG procedures is not materially different than that of either procedure alone. So they feel -- no added risk, two issues resolved. Move on. Deal with it in the future if needed, and with future technology.

I'll bet that Edwards Lifesciences has projections of the service life of their current (third generation) tissue aortic valves. I'll bet it is longer than your docs think.
 

hx77

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Thanks Steve, I agree with your logics. There are risks not replacing it immediately just like there are risks replacing it too soon.

My surgeon decided to postpone my surgery so we could be on the same page. MIDCAB for LAD is something we are discussing.
 

Agian

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I'll take advantage of Fred's buoyant mood to share something funny. I saw the cardiologist yesterday for an echo. I asked him how do I shrink the size of my atrium. Do you know what the prick said? 'How do you shrink the size of your gut?... The gut has to go.' LOL
 

Nocturne

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hx77;n880549 said:
It is simple. I have CAD. I need to eat more green vegetable to prevent calcification of my arteries and heart tissues.
With all due respect, Pellicle may not be the best source of advice for someone with AVS *and* premature CAD. I'm just saying.

Have you had a coronary CT scan done? Do you know your CAC score?

There is some evidence that warfarin accelerates the growth of CAC. For those who have the luxury of average CAC scores, this may not be a big deal, but if you need CABG in your early 50s your CAC score is probably significantly North of average.

Have you had your Lp(a) checked? There is a reason I am asking.
 

pellicle

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Nocturne;n880603 said:
Pellicle may not be the best source of advice for someone with AVS *and* premature CAD. I'm just saying.
I made no comments or inputs on that matter, as I know well its outside my area of interest.

So whatever sauce you are meaning its of your own making.

I confined my answers to what I know well; warfarin
 

hx77

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Nocturne;n880603 said:
Have you had your Lp(a) checked? There is a reason I am asking.
Hi Dr Nocturne,

What you described is a very likely cause. I did a CT scan 3.5 years ago. My calcium score was 777,mainly on the left side: Left Main 193, LAD 473, LC 106. My cardiologist did not ask me to do angiogram because she thought it's invasive.

I haven't had Lp(a) tested but I will. I would appreciate it if you could share more on the topic. Thank you very much!

John
 

Nocturne

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hx77;n880613 said:
Hi Dr Nocturne,

What you described is a very likely cause. I did a CT scan 3.5 years ago. My calcium score was 777,mainly on the left side: Left Main 193, LAD 473, LC 106. My cardiologist did not ask me to do angiogram because she thought it's invasive.

I haven't had Lp(a) tested but I will. I would appreciate it if you could share more on the topic. Thank you very much!

John
Ha ha! Doctor Nocturne! I'm the only adult of four living in this house who is NOT a doctor!

Calcium score of 777 at age 50? Well hot damn! That puts you right up in the 99th percentile for age -- just like me. You lucky dog, you!

Considering your otherwise great numbers (and assuming they have always been so), I'd say there is a very good chance that you have astronomically high Lp(a), like me. I'd get that looked into ASAP. Your docs probably never looked at it because they either didn't know anything about it or just don't like feeling impotent because there's really not much that can be done about high Lp(a) (Agian will disagree -- he is partly correct but his methods involve utilizing medication that is prohibitively expensive here in the USA and also niacin, which when I took it seems to have rocketed my fasting blood glucose into prediabetes).

The hopeful news is that there is a medication being developed by Ionis Pharmaceuticals (currently in stage 3 trials) that can lower Lp(a) by over 90%. We'll see how the situation in the States limits that med to the rich and famous, if it even passes through the FDA.

Are you absolutely sure that your valve is bicuspid? There is great and growing evidence that high Lp(a) increases one's odds of developing AVS. My own valve is noted as being tricuspid (normal) but "acting" bicuspid -- tricuspid morphology but functionally bicuspid or something like that.

If your Lp(a) is high, you might consider looking at your genetics (as Lp(a) is almost entirely determined by genetics -- it doesn't care what you eat or how much you exercise or how much you weigh). I have two copies of the faulty allele LPA rs 10455872, which results in sky high Lp(a) levels and about five times the normal chance of developing AVS. I learned this on my own by getting a 23andme genetics test done and from information gleaned at the Lp(a) Foundation website.

Here are a few things to look at:

Lp(a) Foundation Website:
http://www.lipoproteinafoundation.org/default.asp?

Lp(a) Foundation video about Lp(a) and AVS:
https://www.youtube.com/watch?time_continue=12&v=u6ed3DNRdkU

MESA risk score calculator, CAC inclusive:
https://www.mesa-nhlbi.org/MESACHDRisk/MesaRiskScore/RiskScore.aspx

pdf of a Nomogram predicting 5-15 year survival, CAC inclusive:
medicalxpress.com/pdf416763197.pdf

The most recent and most positive study regarding AVR and relative lifespan I have found to date:
j-atamis.org/icfj/index.php/icfj/article/download/138/pdf-2

The most positive study on long term survival with high CAC I have found to date:
https://www.sciencedirect.com/science/article/pii/S0735109707019328

If you want any help interpreting any of that, I'd be happy to. I will say that there are studies out there with less positive conclusions -- I'm just offering you the happy ones.

In a nutshell, if these studies are to be believed, your high CAC score shaves less than 5 years off of your life on average, and if you had AVR right now you'd have about a 75% chance of living at least another 20 years.

Get your Lp(a) checked, and if it's very high and you have kids, have them get theirs checked too. Mine is a monstrous 160+ (where 12 or so is average and 50 is "extremely high risk"), and my 4 kids are 50, 50, 100, and unknown. If Ionis' drug works, I want them on it before they start having to deal with this nonsense.
 
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