The ATS 3f equine bioprosthetic valve. Anyone know about it?

[TXWildflower]

After a frustrating few months and a series of tests, it turns out surgery for AVR is in the cards (as it has been for more than 10 years) but not just yet (another post tells that whole saga.) I had gone so far as to schedule consultations with surgeons so I kept those appt’s. The second surgeon I spoke with, Dr. John Oswalt (Austin, Tx), brought up a valve type that I hadn’t heard of before on this forum and after doing some research I am not finding much but press releases and what is on the manufacturer’s website – the manufacturer is ATS. The bio-tissue value is known as the ATS 3f - made from equine pericardial tissue (i.e. horse). Surgeon said that a horse has less fat than pig or cow potentially leading to less chance for calcification they believe. It was fairly recently approved by the FDA for use in the US. The fact is that they haven’t been using it long enough to have long term stats. I think one clinical study has been going on for 6 years.

Here is a release to a press release http://www.bio-medicine.org/medicine-news-1/ATS-Medical-Announces-First-Commercial-Implants-of-the-ATS-3f-Aortic-Bioprosthesis-in-the-United-States-30414-1/

I came across an announcement for a newer clinical study to start implanting this valve in patients under the age of 60 http://www.news-medical.net/news/20...nger-aortic-valve-replacement-population.aspx That was from August 2009. The surgeon didn’t mention anything about a clinical study, but I wonder if that is what he had in mind. He just mentioned this was a valve he was excited about, that it is showing promising results (so far). He also felt like this valve type would be one that would be a candidate for a 2nd replacement down the road (if/when necessary) with a new valve via the trans-catheter approach, which is now in clinical study on patients that are not candidates for OHS. However no one can say that for sure. I am still hoping that this trans-cath procedure will be a viable choice later should I need it.

Do any of you have information you can share about this valve? Anyone have first hand experience with it?

My surgery is still probably at least a year away and so I am not in a hurry to decide, but thought I’d check in with y’all, the experts, to see what you might know or if you can steer me towards more info. Maybe it isn’t wise to be a guinea pig for something that doesn’t have a proven track record. I suppose someone has to go first, but do I want that to be me? I don’t know.
The ATS 3f is reportedly made in a tubular shape more like a natural valve per ATS web site: http://www.atsmedical.com/Products.aspx?id=2532 The highlights of a portion of their info below.

· Because it is tubular, the ATS 3f® Aortic Bioprosthesis restores physiologic, non-turbulent trans-prosthetic flow that is indistinguishable from flow across a native aortic valve.4
· The ATS 3f Aortic Bioprosthesis is a stentless pericardial valve that replaces the diseased native aortic leaflets.
· Since there is no bulky stent, minimal tissue is implanted achieving essentially a 1:1 annulus to orifice ratio and laminar flow, just like a native valve.

One other thing of note I saw in the fine print is that people with BAV were not eligible for this valve. There is still no consensus as to whether I have 2 or 3 leaflets in my valve. This surgeon after reviewing the heart cath thought it was three but can’t say for sure. I would definitely have a plan B valve choice if I even chose to go this route. I’ve read before on this forum that one should have a plan B anyway.

Thanks!

Rhena

 

[Lynlw]

I haven't read any of the info, but where did you read BAV are not candidates for the valve? IF that is for the clinical trial, That would make more sense than, if there are saying they will never use this valve on people with BAV, I know BAV is something that is excluded in other clinical trials right now like the percutaneous valve replacement trials.

Also I don't have a link, but have been told the CE perimounts is one of the valves that can be replaced later on with the percutaneous valves. I'm not sure about the other tissue valves.

 

[TXWildflower]

I haven't read any of the info, but where did you read BAV are not candidates for the valve? IF that is for the clinical trial, That would make more sense than, if there are saying they will never use this valve on people with BAV, I know BAV is something that is excluded in other clinical trials right now like the percutaneous valve replacement trials.

Also I don't have a link, but have been told the CE perimounts is one of the valves that can be replaced later on with the percutaneous valves. I'm not sure about the other tissue valves.

I read it on the ATS website itself under Products/ATS 3f Bioprosthetic Valve. http://www.atsmedical.com/Products.aspx?id=2532
I'm pasting in the exact wording. See the contraindications. It wasn't in the context of the clinical study where I read it. Thanks for the info on the CE perimounts also being candidates for percutaneous replacement down the road.

INDICATIONS:
The ATS 3f® Aortic Bioprosthesis, Model 1000 is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.

CONTRAINDICATIONS:
The ATS 3f® Aortic Bioprosthesis, Model 1000 should not be used in those patients who present with congenital bicuspid anatomy or other forms of abnormal aortic root geometry.

Rhena

 

[Lynlw]

I read it on the ATS website itself under Products/ATS 3f Bioprosthetic Valve. http://www.atsmedical.com/Products.aspx?id=2532
I'm pasting in the exact wording. See the contraindications. It wasn't in the context of the clinical study where I read it. Thanks for the info on the CE perimounts also being candidates for percutaneous replacement down the road.

INDICATIONS:
The ATS 3f® Aortic Bioprosthesis, Model 1000 is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.

CONTRAINDICATIONS:
The ATS 3f® Aortic Bioprosthesis, Model 1000 should not be used in those patients who present with congenital bicuspid anatomy or other forms of abnormal aortic root geometry.

Rhena

That's interesting I wonder why

 

[Lynlw]

Ok, I'm not completely sure but it looks like when they use this valve they don't remove the origonal valve, but just the leaflets and put the tube inside the older valve, which would make sense that would rule out bicuspid or other "forms of abnormal aortic root geometry"

 

[ShezaGirlie]

This is really interesting..!

 

[Equusz]

As a horse lover, I don't know if I'd feel right about having a poor horse's valve in me. On the other hand, maybe it would serve as a sort of equine tribute. Would have to think about that one.

 

[TXWildflower]

I agree Equusz - a good tribute to a horse if indeed the valve proves to be up to the task. I was leaning towards a bovine valve - just because I could imagine it as maybe coming from a Longhorn, and people in Austin bleed orange don't you know. I am a big fan of the Ducks too though as my favorite Uncle was from Oregon and he was a fan, so since he is no longer with us I have to keep the spirit going.

Well this must be a really new valve because I sure haven't gotten much feedback on my question. Any of you Europeans out there know anything about the valve or clinical studies going on there? I believe it has been available in Europe for awhile, but I could be wrong. Guess I need to do some more homework.

Rhena

 

[tobagotwo]

This has a picture: http://www.asianhhm.com/knowledge_bank/technotrends/aortic_bioprosthesis.htm

Gotta go to work now, but will be making comments later. This is not unlike a three-cornered version of the "automatic" drain plug used on small boats, sort of a whoopie cushion-type, one-way valve made from horse pericardium.

Note that there is only a bit over six years' worth of clinical experience with this valve at this point. Interesting.

Best wishes,

 

[vhmoriarty]

I havent heard anything about this valve, but medicine changes daily. I am having the Ross Procedure done. They replace your aortic valve with your pulmonary valve. And in place of the pulmonary they put a human donor valve. Although it depends on the doctor as well. If you have not heard of this procedure I suggest you look into it as well.

Wishing you the best. Everyone here is here for you, there are guardian angels all around and dont hesitate to ask questions.

 

[ALCapshaw2]

This will probably get me in trouble in some circles but ...

Where are all the Nay Sayers (yeah, I get the pun) who said the On-X valve was "Too New and Too Untested" after 70,000 On-X valves had been sold in 64 countries over the previous 12 years?

That was a pretty common excuse given by several Surgeons as reported by some of our members who dared to ask about using that 'new and improved' valve.

(Note to Ross: Tell me if this is too controversial and I will delete it.)

 

[Lynlw]

This will probably get me in trouble in some circles but ...

Where are all the Nay Sayers (yeah, I get the pun) who said the On-X valve was "Too New and Too Untested" after 70,000 On-X valves had been sold in 64 countries over the previous 12 years?

That was a pretty common excuse given by several Surgeons as reported by some of our members who dared to ask about using that 'new and improved' valve.

(Note to Ross: Tell me if this is too controversial and I will delete it.)

I'm not really sure of what your point is, but considerring this valve can NOT be used if you have BAV and that wipes out alot of the poeple who need AVR, and the few people that did respond said it seems to new to know much about it, and no one here said there were getting this valve, just asked if anyone knew anything about it. I'm not sure what your complaint is?

 

[tobagotwo]

Al is referring to the lack of conscientious cynicism in this thread. Generally, a valve this new gets a good hazing when someone brings it up. After all, this valve has no proven track record for longevity at all, including in clinical trials.

Six years is a very, very short test span for a valve without a functionally similar predecessor. I'm not certain what the requirements are for FDA approval, but, unless I am missing something, this is really abbreviated. The first implants for the valve's trials were at the end of 2001, and was eventually 400 patients. The results were apparently accepted based on patient-hours, rather than linear time.

Then again, if the FDA lets things in too quickly, they're accused of not testing them enough for patient safety, and if they delay submissions for more testing, they're accused of keeping wonderful, new, lifesaving products off the market, to the detriment of the patients. Can't win that one.

This valve is really a set of replacement leaflets, rather than a whole new structure, which is what allows it to take up less space. As of yet, I am leery of the claims, unless I am misunderstanding them. Apparently they remove the leaflets from the old valve, then place this into the annulus, in the shadow of the original cusp-retaining tissue. This leads to the statement that the patient doesn't lose any effective valve area. Their press release indicates a 0 mmHg (yes, zero) or 2 mmHg gradient in some cases. However, their official, FDA-approved gradient chart shows:

Size Mean Gradient
19 mm 3.10
21 mm 5.87
23 mm 5.89
25 mm 5.96
27 mm 4.00
29 mm 3.77

...lower than other valves, but not zero, or even 2.

But there are three suture patches that go in "downriver," and it's hard to see that they would not affect bloodflow or turbulence. The statement is that there is no stent, but those basically serve the function of the stent, and have palpable thickness and presence away from the base of the valve. How can they not interfere at all?

It seems likely that they do. In looking at the design, there should be a tug at the three "downriver" commissure pads sewn to the aortic wall with every cycle. My guess is that the restriction on bicuspid valves is aimed at the connective tissue disorders (that only sometimes go with it). The three points of tugging would be likely places for unintended detachment in an individual with developing myxomatous tissue problems, and might even foment the start of an aneurysm for some who have that proclivity. There also might be concern with the "single line of sutures" securing the base tearing away from weakened tissue in some congenital cases.

The fact that it's tubular is not new. The Toronto stentless porcine valve is tubular, as is the root-included Hancock and the Freestyle. It doesn't require replacing a section of aorta, though.

They do warn and disclaim about calcification. They currently show 99.7% freedom from structural failure after 60 months, but that is close to typical for 3rd generation tissue valves. They don't highlight (obviously) other points of failure.

We won't know for about 14 years how these stack up for longevity. They could be great. They might start failing next week or next year. At this point, I'd consider them experimental, personally. But a very interesting future possibility for non-bicuspid patients.

Best wishes,

 

[Duffey]

Where are all the Nay Sayers

Neigh, neigh!

 

[Bryan B]

First of all people might actually want to read the literature on the 3f valve. It is obviously available at the ATS site:

http://www.atsmedical.com/Products.aspx?id=2532

This video has two different surgeons discussing what they feel the advantages are of the 3f valve as compared to a stented valve. On my computer (which is pretty fast) the video takes 30-60 seconds to load and requires Quicktime.

http://www.atsmedical.com/uploadedFiles/Public_Site/Products/ATS_3f_Interviews.mov
____________________

Finally, I was curious enough to e-mail ATS to find out more about the 3f valve. I am looking at the possibility of having (I hope) a David Procedure within the next 3 months pending the finding on my next echo coming up next month. My surgeon said that given my most recent echo and MRI he feels that there is a 70% chance that he can save the valve, but obviously I need to choose a backup valve in case he can't save the valve once he gets in there.

One of the contradictions of the 3f valve is abnormal aortic root geometry. At 4.43cm my aortic root would fall into the category. One good thing is that although both my aortic root and aorta are dilated, neither have formed an aneurysm. I got a response from someone at ATS that told me that Dr. James L. Cox was on a trip but would contact me when he got home. This would be the same Dr. Cox that developed the Cox-Maze Procedure. Today I received a brief e-mail from Dr. Cox:

Mr. "Bryan B": I created the 3f valve and
was at Duke for 16 years. Will call on
return. James L. Cox, MD

Obviously I replaced my real last name with "Bryan B".

Here is the bio for Dr. Cox:
http://www.atsmedical.com/Company.aspx?id=966#
____________________

I have figured out over the last 49 years living with heart disease that it never hurts to check out your options and ask questions. If nothing else you will learn something in the process.

 

[Mentu]

Rhena, as with all valve selection, you and your surgeon are going to make this decision together. As a new owner of a "3rd Generation" bio-prosthetic, I can tell you that the track record of the predecessor valves of this series helped me make my choice. I would have been more hesitant to commit myself to it otherwise. As in so many other things, there is a comfort level spectrum....mechanical-bioprosthetic-tissue; you have to decide where in the spectrum you are most comfortable. I would want some specific answers as to why the surgeon recommended that particular valve specifically for you. Does he have a financial relationship with the company? Does this valve offer particular benefit to you personally? How many times has he used this valve? If he can give you good clear answers, it will go a long way towards building your confidence in his recommendation.

 

[tobagotwo]

My last post here just comes from a different viewpoint, deliberately more skeptically looking at the time it's been out, and its lack of similarly functioning predecessors. Even the On-X had very similar predecessors, and the assistance of the fellow who developed the basic structure and composition of all the previous pyrolytic carbon valves. As such, it was partially vetted before it even came out.

This is an entirely different approach, not a redo of earlier valve types. Its main suture is even sewn perpendicular to the bloodflow, rather than into the wall (if I am interpreting the drawings correctly). The point is that we don't know how it will pan out over time, and have nothing to guide our guesswork. So far, it's been great. That's all we know about its reliability and longevity.

Best wishes,

 

[Herb M]

I do not think I would go for a recently developed valve. If I was under 65, I would opt for a valve that has been around long enough and would last at least 20 years.

 

[Bryan B]

I do not think I would go for a recently developed valve. If I was under 65, I would opt for a valve that has been around long enough and would last at least 20 years.

Herb,

I understand where you are coming from. But there had to be patients willing to be the first ones to try the St. Jude Masters and Regent valves, the Onyx valves, the Edwards bovine pericardial valves, and all of the valves that proceeded these valves in the evolution of valve technology. I want to make it clear that I am NOT a proponent of this valve...but I am a proponent of any valve that may make my life better with minimal adjustments to my daily life. When I first found out that I needed aortic valve surgery I thought my only 2 options were mechanical or tissue valve. After doing a lot of research I discovered there were other options and chose the Ross Procedure. Now that my aortic root and aorta are dilated I am going through the same process, and I am simply looking at all of my options, researching them, and then I will make an informed decision based on what I have learned and what my gut instinct tells me is the right decision for me.

I don't blame anyone for wanting to go with the tried and true valves with many years of clinical data to back them up. My only point is that at one time these tried and true valves DID NOT have years of clinical data to back them up. I can tell you right now that if I needed a "simple" aortic valve replacement with no other complications I would seriously consider having the 3f valve implanted. It just makes sense. It's simple. IMO it's the closest thing to a native valve that has been developed so far. But after reading the literature it's a valve that is not for everyone. More than likely it isn't for me since I have a dilated aortic root.

BUT...I am going to talk to Dr. James Cox, the surgeon that created the valve (and the Cox-Maze procedure) before I cross it off of my list. Just like I have been in contact with Dr. Paul Stelzer about my Ross Procedure being complicated by my dilated aortic root and ascending aorta. If some of the best cardiothoracic surgeons in the world are willing to discuss my case with me and give me their opinion then I would be stupid not to take it. I guess that I am stupid enough (or smart enough) to try and contact them on the chance that they might respond to me.

 

[Bryan B]

BTW...if members here are interested in what Dr. Cox has to say to me when he calls (haven't heard from him yet) make your feelings known on this thread and I will post the details of our conversation. If no one shows any interest I won't waste anyone's time.