Foldax Continues

[pellicle]

but perhaps at least get a zoom consult from someone in another clinic.

I'm not sure but perhaps Dr Walter Bishop would be the right guy.

However all gags aside I think he's meaning a mechanical mitral into the Aortic position; but that's speculation on my part.

 

[pellicle]

I don’t think that’s a reasonable goal that meshes well with staying alive.

well as there are people here who've had 5 (I think 7 was the record) lets just leave it at the quotation from the Matrix :
where the architect states that "... there are levels of survival that the machines are willing to accept. "
Besides, we don't know if the fella has a genuine contra-indication to warfarin or not.

 

[ATHENS1964]

Abbot has 31mm aortic valve

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC427374/

 

[Lucker]

I've never heard of such a thing. Is this someone in the medical field telling you this? Hopefully someone with more specific knowledge of this can chime in, but here are my thoughts.
-It is not uncommon for patients to have annulus at 29mm and larger. It is the high end of the range, but not uncommon.
-They make prosthetic valves 29mm diameter. So, having a 29mm annulus should not be a problem.
-I've never heard of replacing an aortic valve with a patient's mitral valve. In the Ross Procedure, the pulmonary valve is transplanted to the aortic position, but this valve is a tricuspid valve with similar function as the aortic. The mitral is significantly different than the aortic valve. It is bicuspid and has strings attached to it, which play a vital role in its function. Moving this valve would also need to involve removing and re-attaching the strings. That would seem to really complicate things.
-If you did that, now you need to get a prosthetic mitral valve as well.

Anyway, if this is a medical person telling you this, get another opinion. I don't know if that is possible in Russia, but perhaps at least get a zoom consult from someone in another clinic.
I really can't see how having a 29mm annulus is a problem, but perhaps someone who knows more than I do can give comment.

Of course not the human mitral valve, but the mitral mechanical prosthesis.
Here's example Use of an inverted On-X mitral valve in the aortic position in a resource limited setting - PubMed
They call 30mm annulus "excessively large".

@pellicle
Yes, backward facing.

 

[Lucker]

So far Foldax only has valves up to 27mm. Only mitral are bigger.

 

[Chuck C]

Of course not the human mitral valve, but the mitral mechanical prosthesis.
Here's example Use of an inverted On-X mitral valve in the aortic position in a resource limited setting - PubMed
They call 30mm annulus "excessively large".

@pellicle
Yes, backward facing.

That is interesting. I will note a couple of things.

The title of the publication, involving one patient:

"Use of an inverted On-X mitral valve in the aortic position in a resource limited setting"

"A 46-year-old male with severe aortic insufficiency underwent aortic valve replacement during a surgical outreach program in Tegucigalpa, Honduras."

Put another way, "We did not have the right sized parts available, so we used a part designed for something else instead." Points for creativity for sure. I would imagine this individual from Tegucigalpa is much better off now than if he did not get the surgery, even if this is not ideal.

Good hemodynamics reported, but there is zero long term data on how a mitral mechanical valve does when put in backwards in the aortic position. It was not designed for this.

As noted, there are larger aortic prosthetic valves on the market. So, to avoid the need to use a backwards mitral valve in the aortic position, I would suggest not getting aortic valve replacement done in Tegucigalpa Honduras, or in any other setting in which the resources are limited. Consult with the clinic where you plan to get your procedure well ahead of time and make sure that they have the right sized aortic valve available for you.

 

[erricojj]

I've never heard of such a thing. Is this someone in the medical field telling you this? Hopefully someone with more specific knowledge of this can chime in, but here are my thoughts.
-It is not uncommon for patients to have annulus at 29mm and larger. It is the high end of the range, but not uncommon.
-They make prosthetic valves 29mm diameter. So, having a 29mm annulus should not be a problem.
-I've never heard of replacing an aortic valve with a patient's mitral valve. In the Ross Procedure, the pulmonary valve is transplanted to the aortic position, but this valve is a tricuspid valve with similar function as the aortic. The mitral is significantly different than the aortic valve. It is bicuspid and has strings attached to it, which play a vital role in its function. Moving this valve would also need to involve removing and re-attaching the strings. That would seem to really complicate things.
-If you did that, now you need to get a prosthetic mitral valve as well.

Anyway, if this is a medical person telling you this, get another opinion. I don't know if that is possible in Russia, but perhaps at least get a zoom consult from someone in another clinic.
I really can't see how having a 29mm annulus is a problem, but perhaps someone who knows more than I do can give comment.

My 6-month-old aortic Inspiris Resilia model 11500A is 29mm. Hopefully, my surgeon measured twice and cut once.

 

[nobog]

A valve is a valve - mitral and aortic prosthetic valves are the same except for the cuff and the way they are mounted on the valve holder (what the doc uses to help implant the valve). Cuffs are available up to 35mm. The largest On-x valve is a 25mm then they use bigger cuff's to make up the difference.

 

[Springdogg]

If you’re getting a new bioprosthetic valve every 10 years then you’re gonna need to have 4 more OHSs in your lifetime. I don’t think that’s a reasonable goal that meshes well with staying alive.

I’d recommend changing your path before it’s too late. Just my opinion so take it for what it’s worth … maybe nothing.

Most definitely not my plan. This is my last tissue valve. Next up is mechanical unless something like the Foldax valve was available.

 

[Chuck C]

A valve is a valve - mitral and aortic prosthetic valves are the same except for the cuff and the way they are mounted on the valve holder (what the doc uses to help implant the valve). Cuffs are available up to 35mm. The largest On-x valve is a 25mm then they use bigger cuff's to make up the difference.

Interesting to know. Thanks

 

[Lucker]

In case of polymeric flexible valves I can see why there may be a difference in engineering between aortic and mitral valves. For example wider and/or shorter valve may require more strength in the flexible cusps.

 

[nobog]

In case of polymeric flexible valves I can see why there may be a difference in engineering between aortic and mitral valves. For example wider and/or shorter valve may require more strength in the flexible cusps.

It's unlikely that a manufacturer would go down this path as this would require 2 separate engineering endeavors and FDA (as well as every other governing body) submissions.

 

[Lucker]

Actually Foldax aortic valve has the cuff outside diameter of up to 36mm, so a large annulus should be covered, and intra-annular implantation should be possible too, which gives annulus size of 36mm. Good.

 

[Kkch.i]

I found out about polymer valve after having my first tissue valve. This can be a game changer especially for younger patients, myself included. I am trying to estimate how long it possibly takes Foldax for FDA approval. Please correct me if I am reading the articles wrong! Any help pointing me into the right research direction is appreciated!

Disclaimer
I am very new to this side of the world and have no medical background. I am using Edwards Resilia Tissue Valves' timeline for reference. I am not super optimistic that Foldax FDA approval will happen anytime soon, nor am I planning future surgeries based on hope. Just want to collect and analyze available information.

Edwards Timeline
It looks like studies can be conducted in parallel. It took at least 7 years for Resilia aortic valve and 12 years for Resilia mitral valve to be FDA approved?

1. When were the Resilia Tissue Valves first designed? - Can not find information...
2. Animal study - 2010, n = 45, 8 months *
3. EU feasibility study (AVR) - 2011, n = 133, 5 years *
4. Commerce trial (AVR) - 2012, n = 689, 5 years *
   
   • More specific timeline via a second source: Jan 2013 - Mar 2016 **
5. Resilia aortic valve FDA approval - Sept 2017 ***
6. Resilience study - 2018, n = up to 250, 11 years *
7. Resilia mitral valve FDA premarket approval: Mar 2022 ****

References

* Inspiring Results | Edwards Lifesciences​

** Five-year Outcomes of the COMMENCE Trial Investigating Aortic Valve Replacement with RESILIA Tissue - PubMed ​

*** Edwards Inspiris Resilia Valve Receives FDA Approval​

**** https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P150048S047 ​

 

[Lucker]

Kkch.i​

Here are the links to the US Early Feasibility Studies for aortic and mitral surgical Foldax valves. As stated there, the estimated Study Completion Date is December 2026 and December 2025. Will the valves be cleared for use after these studies, I am not sure, don't know the usual procedure.
https://clinicaltrials.gov/ct2/show/NCT03851068https://clinicaltrials.gov/ct2/show/NCT04717570These studies are official and related to the US FDA. Some non-FDA studies are already done, so I thinks there is a chance for approval sooner than 7 years.

May be someone (nobog?) will give us a hint if the successful completion of the Early Feasibility Study results in FDA approval.

Also the regulating body for the ongoing trial of the aortic valve in India (DCGI) is paying attention to the US study, they asked for the FDA application materials. Indian trial is expected to pass faster, may be even in this year.

 

[nobog]

The FDA will pay a high scrutiny on this valve as it is "new". New is relative as this valve has been around in one form or another for decades. Their study states " (to show) significant improvements in clinical hemodynamic performance" - doubt they will be able to prove this but more importantly will be the durability and free from complications data.

One will never know with the FDA - they will have questions that might significantly delay approval.

As mentioned before - what makes a good heart valves: 20 years

 

[Kkch.i]

@Lucker @nobog Thank you for the links and the information! I compared the study types, timelines and sample sizes.

It seems that the Edwards Resilia case was classified as high risk, Class III devices* because they needed the Pre-market approval. Their commercial trial was a 5 year IDE study with 689 patients. I suspect that Foldax will follow a similar path and need to reach statistical significance with similar if not bigger sample size.

I cant find the sample size of their India clinic trial. Wondering if that would be large scale.

Ref:
*Exploring FDA approval pathways for medical devices

 

[nobog]

@Lucker @nobog Thank you for the links and the information! I compared the study types, timelines and sample sizes.

It seems that the Edwards Resilia case was classified as high risk, Class III devices* because th.....

FYI, all heart valves are high risk Class III medical devices.

 

[tommyboy14]

We are always discussing the whether a valve like the Foldax one will be last forever. But there are other complications that can occur. I.e. some tissue valves may still throw clots once in a while on account of their design. We also dont know if other complications can occur from the interaction of our bodies with the new material. I think that the Foldax is an incredibly exciting development, but am also of the view that the above reasons are why a 5-year study will be required before this valve is approved.

Even when the Foldax valve is approved, there will be a residual risk of unknown adverse events for a couple of years. I.e. if you look at the St. Jude Trifecta valves, some surgeons where pushing that it would last longer due to low gradients etc, but now we know that this valve fails early. And this is with a material that whose side effects in the human body were already widely explored.

Bottom line: We will not know if the Foldax is superior to other valves or not for at least another decade or so...

 

[pellicle]

We are always discussing the whether a valve like the Foldax one will be last forever. But there are other complications that can occur

indeed and wise words.

If we are BAV then we have a connective tissue disorder. I didn't know at 28 (nor did I really care) that I'd develop an aneurysm nor that I'd require a valve replacement. All I knew was "we wait and see".

So I set that as a background and went about living life with my only goals being to develop myself and keep on learning. I packed a lot into the time between 1992 and now. I'm really happy with the way my life went (although there certainly are a few things I'd like differently).

We never know what will actually happen tomorrow, so I count BAV as a blessing for me actually knowing that and acting like that.

I could die suddenly right n