ValveExchange - Are these exciting times or should I not get my hopes up?

[reddwarf]

I've been keeping a close eye on the progress of the clinical trials of the Vitality 2-part valve from http://www.valvexchange.com. As those doing the same are probably aware the human clinical trials have now been completed and the company is expecting CE approval later this year if all goes well. I'm currently in the waiting room for AVR and although doctors currently agree that I don't yet require the surgery, given some of my symptoms I can't help but feel surgery can't be far away - within months to max a year.

The vitality valve would without a doubt be my choice of valve were it available today. It seems like a no brainer. My questions are:

1. Does anybody know what actually happens once something like this has been approved? Does it still take years before this is available to the average Joe? I mean obviously training needs to happen and presumably hospitals need to agree on their own implementation plans of which I'm sure there is a commercial decision as well. Given all these factors, is it pointless to get excited about this for the moment?

2. Is there anybody on this forum that was part of the human trials or does anybody know anybody? What has been the experience so far and what are doctors monitoring progress saying?

3. If this product became available on the market tomorrow, would you go for this given it's infancy in the market?

Curious to get some thoughts, afterall this valve looks like a game changer.

 

[pellicle]

wasn't something like this just posted the other day?

It seems promising, but I have to wonder about the language of that page. For instance:

Younger and physically active patients often receive mechanical heart valves that do not wear out, but require lifelong high doses of anti-coagulation drugs that force a sedentary lifestyle with serious side effects.

the part that I underlined is skimming close to bullshit, if not a direct hit. Seems like promo stuff seeking investors rather than plain-simple medicine.

I would say that (without "knowing") it would be:
* some years before its available
* there be some 'issues' for some poor souls who get it and it goes south
* some more years before surgeons accommodate for the techniques for it
* probably only available if you have a BAV and no other complications and never had any other surgery on your BAV


but yes, we do live in interesting times. Heck it was only when I was a lad that people lived badly and died early from having a BAV (as there was no surgery).

 

[reddwarf]

wasn't something like this just posted the other day?

It seems promising, but I have to wonder about the language of that page. For instance:

I haven't been on this site for a while so apologies if I've posted something that's been discussed. I didn't see it and still can't find it if I search (crap search function on this site). I personally wouldn't read anything into their "language". It's just marketing babble and at the end of the day, all medical inventions are driven by commercial objectives to a degree and I would expect this type of talk on any valve manafacturers website.

The point is this technology now "in use" which I think is incredibly promising and given all the lessons learned as valves have got more advanced, the stringent approval processes that exist these days & the animal and lab testing that must have taken place, one would expect the chance of a design flaw to be rather minimal. I just hope they get a move on as I would love to be able to throw this into the mix when it comes to valve choice, even with it in it's infancy.

I think the real test will come in a few years when the valve wears out for the trialers and they are able to replace everybodies leaflets with keyhole surgery and no complications. I wonder what the age of their subjects were? It would seem a bit pointless if they were old and don't get to see the valve wear out - but I'm sure they factored that in.

 

[Agian]

Would I choose this if I was to be operated on tomorrow? No bloody way. The references they use are old, the arguments are concrete. Things will get better.

 

[pellicle]

I haven't been on this site for a while so apologies if I've posted something that's been discussed.

None needed

Perhaps it was somewhere else?

Ahh ... here
http://www.valvereplacement.org/for...l-valve-or-a-tissue-valve&p=540885#post540885

 

[dtread]

Contrary to what was indicated despite considerable research I have never seen any precautions about Coumadin/Warfarin regarding exercise other than to avoid high risk or contact sports. I would agree with Pellicle's statement. No reason that you have to become a couch potato if you're taking Coumadin/Warfarin. Exactly the opposite; exercise as much as you like, just avoid high risk and contact sports. Could not find anything on this company or their product on ClinicalTrials.gov

 

[chaconne]

This seems to be a very good, attractive, and technologically sensible idea. Having a cath every 10-20 years rather than OHS would be great. But I agree with others in that it may be a long time before it's ready for regular use. I wonder what unforeseen problems may be encountered.

 

[Luana]

My AVR surgery was almost 4 years ago, and before then, the buzz was, oh they're all going to be done by catheter very soon.

Still hasn't come down the pike yet. Maybe "very soon" means 10-20 years? I don't. know. I wouldn't hold my breath, and I would not make a decision on a valve needed now based on what might be available in the future.

There is nothing, absolutely nothing, about warfarin that requires or forces anyone into a sedentary lifestyle.