Edwards Wins Panel Support to Sell First Less-Invasive Heart Valve in U.S.

[ks1490]

Good progress for the Edwards valve and its implantation approach...

http://www.bloomberg.com/news/2011-...-first-less-invasive-heart-valve-in-u-s-.html

 

[ken taylor]

In my humble openion I think this is for folks that could not make it through surgery, I think it is equal to a Hail Mary pass in the last second of a football game. With that said it will help those folks and that is a good thing.

 

[catwoman]

Curious -- this for an AV. Perhaps more people who would be likely candidates for this suffer from AS than folks who have MV problems.... It seems that AS is more common as we age than MV problems, but that could just be my perception based on the 8 years since my MVR. More people can get along with MV prolapse w/out it going to regurge than those with AS due to calcification.

 

[Lynlw]

In my humble openion I think this is for folks that could not make it through surgery, I think it is equal to a Hail Mary pass in the last second of a football game. With that said it will help those folks and that is a good thing.

There are alot of different opinions about when the percutaneous valves will be available to anyone but Right now, in the US for the trials it is for Patients who were too high risk for surgery in 1 arm "B" of the PARTNER trials and the other arm cohert A was for people who were high risk, but candidates for surgery, since 1/2 the patients had surgery and the other 1/2 had TAVI.
Because the patients that were too high risk for surgery did so much better Than the medically treated patients in the PARTNER Trial, when Medtronic Corevalve started their trials the FDA allowed them to drop its planned randomization of patients to the device vs best medical therapy, allowing all of the "inoperable" patients in this arm of the trial to get the device. and the trial is just for "high" surgical risk, where patients will either have TAVI or surgery. http://www.theheart.org/article/1174205.do

There is an interesting webcast with some of the leading experts around the world discussing percutaneous valves and the future http://www.theheart.org/editorial-program/1238155.do that I was pretty suprised to read right NOW "In 2011, one out of two cases of biological aortic heart valve replacement in Europe is taking place via transcatheter procedure. it is broken down into several chapters, but the whole webcast is about 25 min long.

As for why this is for Aorta, this valve/trial is for Aortic valves, but I'm pretty sure they are working on all kinds of percutaneous procedures, the first one that is already FDA approveed was for pulmonary valves, (Melody) and only about 5000 PVR are done each year, but that is the group of patients that usually has to have the most surgeries, so I believe that is one of the reasons they started working on that valve first. it also is being used for the most part children and young adults that are very active.

I'm sure the fact tens of thousands of people have Aortic valve replacements each year, so there is big money in it, probably plays a large part in why so many companies are working on their own percutaneous Aortic valves, I'm not sure but I think the focus for Mitral valves, is more on ways to repair it by cath or min invasive.
It's a pretty exciting time.

 

[ElectLive]

Interesting webchat, thanks for posting Lyn. Even with the much more widespread use in Europe, it sounds like stroke is still the achilles heel. Fortunately, solutions are being studied, though, only time will tell.

 

[Lynlw]

Interesting webchat, thanks for posting Lyn. Even with the much more widespread use in Europe, it sounds like stroke is still the achilles heel. Fortunately, solutions are being studied, though, only time will tell.

here's an Intersting article about the stroke risks for the PARTNER trial, http://www.theheart.org/article/1222991.do PARTNER A: Stroke with TAVI speaks to arteriosclerotic burden, baseline risk

"New details on the neurological events suffered by the high-risk patients in the PARTNER A transcatheter aortic-valve intervention (TAVI) trial show the risk of major stroke was low with both surgical valve replacement or TAVI using the Sapien valve (Edwards Lifesciences) and that the risk of neurological events appears to correspond to the patients' overall arteriosclerotic burden....

...However, Miller stressed, the 30-day risk of a major stroke was low and statistically similar with both TAVI and surgery: 2.3% in the surgery patients and 3.8% in TAVI patients in the overall PARTNER A cohort (p=0.25). Among the transfemoral-eligible patients, the rates of major stroke at 30 days were 1.4% in the surgery patients and 2.5% in the TAVI patients (p=0.37).

Miller and colleagues also explored baseline characteristics associated with subsequent neurological events. As Miller showed here, TAVI patients with the most severe aortic stenosis, as measured by aortic-valve-area index, were at the highest risk for a neurological event within the first month of their procedures. After the early-risk phase, patients at higher risk were those patients determined at the outset to be transfemoral-ineligible. Of note, these patients had a higher baseline arteriosclerotic burden than the transfemoral-eligible patients, as evidenced by a higher rates of peripheral vascular disease, higher rates of previous coronary bypass operations, and higher rates of previous carotid artery surgery.

Other risk factors for later neurological events included history of recent stroke or TIA and more severe heart failure"


But yes, they are working to improve the risks, already there are smaller sheaths and they have a new nose cone that seems to be helping. Plus as a few discussions I've seen pointed out for the most part, the surgeons were the many of top surgeons in the Country, so their risks of strokes for patients that sick with comorbidites, is probably lower than the average surgeries.

 

[ElectLive]

More good info. It certainly seems reasonable to expect reduced stroke numbers with a shift in the target patient population (younger and more healthy). Improved devices and techniques will be just as important. I'd not heard of the smaller sheaths and nose cone, but had heard of filtering devices that are being studied to deal with pieces of calcium breaking off as the valve is pushed in during the procedure, that can get broken loose and go to the arteries to the brain.

It's funny how we evaluate progress sometimes. If I'd been told pre-surgery (open heart) that my stroke risk was 4%, I probably would have just nodded my head, and not worried too much. But knowing it's 1%, in comparison, a TAVI procedure with 4% stroke risk just sounds a lot worse than big picture it really is. Clearly it's important...But if those stroke numbers in the article are the absolute worst case scenario (new technology and new experience for surgeons combined with highest risk patients), it's certainly not too hard to be optimistic about the future.

 

[ks1490]

Lyn, thanks so much for the additional info. You've always been such a good resource for me.

 

[enkaynj]

Just wondering if the stroke chance will be reduced in re-valving cases when the trans-catheter valve can be implanted before the previous valve calcifies too much. say in 10 years instead of 15 years. Also wondering if the manufacturers have thought of removing the trancatheter insert valve at a later time to re-re-valve down the road or will they be able to just keep inserting more and more valves as needed like a plastic christmas tree stack (I doubt it) just curious..

 

[Paleowoman]

In 2011, one out of two cases of biological aortic heart valve replacement in Europe is taking place via transcatheter procedure.

I'd like to know where they got those figures from because that's not what I've heard from my cardiologist or from UK or French sources that I have. What I've heard is that they're only using the transcatheter procedure for patients who cannot undergo open heart surgery. It may be that they are aiming to use this method in the future for most people but it's not the case right now.

Anne

 

[Lynlw]

I'd like to know where they got those figures from because that's not what I've heard from my cardiologist or from UK or French sources that I have. What I've heard is that they're only using the transcatheter procedure for patients who cannot undergo open heart surgery. It may be that they are aiming to use this method in the future for most people but it's not the case right now.

Anne

This came out of the European PCR convention EuroPCR 2011 they just had in Paris in May, the panel members discussing it were Drs Martin Leon,(US) Alain Cribier( France), Pieter Kappetein, and Stephan Windecker, who are some of the doctors who are pretty much the experts in the field, Cribier invented TAVI, so I personally would believe they are up on the lastest facts. They said it is right now in 2011 so far.

I know even a couple years ago IT ws JUST for patients who could not undergo open heart surgery and the other option was just drugs. but even the US trials for the past several years were higher risk, not Unoperable and "higher risk" isn't even as awful as I would have expected, but if your chances of mortality during surgery were 15% because of how sick you are and comorbidities (lungs kidney, previous strokes, previos CABGs) as well as euroscore or in the US NYHS class. So 1/2 the patients had TAVI and the other half OHS.

 

[Lynlw]

Just wondering if the stroke chance will be reduced in re-valving cases when the trans-catheter valve can be implanted before the previous valve calcifies too much. say in 10 years instead of 15 years. Also wondering if the manufacturers have thought of removing the trancatheter insert valve at a later time to re-re-valve down the road or will they be able to just keep inserting more and more valves as needed like a plastic christmas tree stack (I doubt it) just curious..

In the PARTNER Trial at least, first alot had to do with these are very sick with lots of comorbidities and pretty old (about 80 plus years) patients, So that probably played a big part of the reason the stroke risk was as 'high" as it was -which is relatively low- 2.3% in the surgery patients and 3.8% in TAVI patients in the overall PARTNER A cohort (p=0.25).
Among the transfemoral-eligible patients, which for the most part were the slightly healthier of the "sick' patints since they could go thru the groin, the rates of major stroke at 30 days were 1.4% in the surgery patients and 2.5% in the TAVI patients. So comparing apples to apples the difference in TAVI vs OHS were a little closer to about 2/1 not 4/1

PLUS as mentioned before these were the first generation devices, that they have already improved a few things on, made smaller AND for the most part the doctors only did 1-2 of the TAVIs before the trial started, compared to surgeons in the best centers who've been operating for decades in many cases, so I'm sure there is some learning curve.

They (Edwards Sapien) started a PARTNER II trial that is healthier patients So it will be interesting to see what the prelim results look like at the end of the year, with not only healthier, slightly younger patients, but doctors already have experience going into the trials. I believe, but don't quote me, that they also are using the improved valves and delivery systems.

Plus Medtronics Corevalve trials are going on now, they just are HIGH Risk paients, since PARTNER's results were so much better for the unoperable patients who had TAVI vs medical treatment, the FDA told them they did NOT have to break the Highest Risk patients into random, TAVI vs medical arms, since they didn't think it would be fair to make patients eligible for TAVI to have to chance getting just the medical treament when they knew from Partner, their outcomes wouldn't be that good.

There are so many companies, doctors working on their own percutaneous valves since many believe that will be the future so there will be big money in it, that who knows what they are working on to improve the valves. Right now, they can put 1 percutaneous valve in another, I doubt they would do a few of them inside each other, but chances are someone in their 50s that got a tissue valve NOW by OHS probably wouldn't need too many replacements even IF the TAVI valve they get when this valve needs replaced only last 10 years.

MY hope the past few years, has been on the Tissue Engineered valves, that research in places like Boston Childrens has been working on, from patients own cells, with the hope the valves could grow with children and last very long in adults since it would be made of their own tissue, the body probably wouldn't attack it. Making them available by cath would be even better..but thats pretty far down the road.
It's a really exciting time.

 

[ElectLive]

Also wondering if the manufacturers have thought of removing the trancatheter insert valve at a later time to re-re-valve down the road or will they be able to just keep inserting more and more valves as needed like a plastic christmas tree stack (I doubt it) just curious..

Well, I'm definintely not counting on stacking Christmas trees, but I was told that I would need to have a 27mm Edwards valve to have a reasonable chance someday at 2 valve-in-valve procedures. It was also my understanding that either a smaller size valve, or a pig valve (at least the one used by my surgeon) in the same size, would have meant no option for repeat percutaneous.

By this logic, I would guess that 3 valve-in-valve procedures would be pretty unlikely for most anyone.

 

[normofthenorth]

ElectLive, I'm having trouble figuring out why TAVI, or repeat TAVI, should work in a cow valve but not a pig valve. Any more details to go on? They seem to work fine in (bad) HUMAN valves. . .

 

[ElectLive]

Norm - Sorry if I was unclear, it's not that they don't work. It's an opening size issue. Of the two tissue valve options with my surgeon, Edwards Magna and Medtronic Mosaic, the Edwards had a bigger opening for the same size annulus, which made the Edwards more likely for repeat TAVI generally speaking. But it's still patient specific and depends on overall valve size. I wouldn't go so far to assume that a 27mm Edwards is guaranteed to give every patient repeat TAVI, it just raises the odds I think. By the same token, depending on size, a pig valve may work in some patients for repeat TAVI.

I wish I could find it right now, but I also remember seeing a minimum valve size for even a single TAVI procedure. It was somewhere on the Cleveland Clinic site; I won't hazard a guess.

 

[Lynlw]

Norm - Sorry if I was unclear, it's not that they don't work. It's an opening size issue. Of the two tissue valve options with my surgeon, Edwards Magna and Medtronic Mosaic, the Edwards had a bigger opening for the same size annulus, which made the Edwards more likely for repeat TAVI generally speaking. But it's still patient specific and also depends on overall valve size. I wouldn't go so far to assume either that a 27mm Edwards is guaranteed to give every patient repeat TAVI either, it just raises the odds I think. I wish I could find it right now, but I also remember seeing a minimum valve size for even a single TAVI procedure. It was somewhere on the Cleveland Clinic site; I won't hazard a guess.

One good thing about the Perimount, is Edwards Sapien was designed to work really well with their valves, and yes better hemodynamics/bigger openings make it much easier to place 1 or more percutaneous valves. I know some of the smaller sizes of valves or at least their openings, not being candidates (natrual or tissue valve) was/is because the valves weren't small enough yet, but I'm sure the lowest size (minimum) of valve you need to have to qualify for a percutaneous valve will keep getting lower (meaning they will fit in smaller openings) as they keep improving (making smaller)- the delivery system and when valves get approved they will start making more sizes then they made in the begining for the trials.

You MIGHT have read the min (or max) sizes to qualify for percutaneous valves at the clinical trial website, since it is usually listed in either the 'inclusion'or "exclusion" criteria for the different trials.
Also i have been told by a few docs, that it is even easier (or better, I can't remember the exact words) to place a valve in a tissue valve than a native one, since they are a known size and are usually perfect circles and of course native valves aren't.

 

[ElectLive]

One good thing about the Perimount, is Edwards Sapien was made to work really well with their valve, and yes better hemodynamics/bigger openings make it much easier to place 1 or more percutaneous valves. I know some of the smaller sizes of valves or at least their openings, not being candidates (natrual or tissue valve) was/is because the valves weren't small enough yet, but I'm sure the lowest size (minimum) of valve you need to have to qualify for a percutaneous valve will keep getting lower (meaning they will fit in smaller openings) as they keep improving (making smaller)- the delivery system and when valves get approved they will start making more sizes then they made in the begining for the trials.

You MIGHT have read the min (or max) sizes to qualify for percutaneous valves at the clinical trial website, since it is usually listed in either the 'inclusion'or "exclusion" criteria.
Also i have been told by a few docs, that it is even easier (or better, I can't remeber the exact words) to place a valve in a tissue valve than a native one, since they are a known size and are usually perfect circles and of course native valves aren't.

Very good point about the size issue more than likely improving over time, and yes it is more than just fitting it in, there has to be adequate hemodynamic response. I tracked down that minimum size I'd seen - in a Lars Svensson - Cleveland webchat in May, he said that a 21 mm Edwards Magna was probably too small for percutaneous at this time (current approved technology).

I have not seen the trial exclusion criteria, but unless I'm mistaken, I think that would only apply to native valves anyway, since the trial hasn't included percutaneous in bioprosthethic valves yet or even percutaneous in native bicuspid. Obviously, that's expected to change though, and I would guess it's already being done in Europe? So much to learn...

Interesting what the doctors said about native versus bioprosthetic valves...makes a lot of sense, back to Norm's point.

 

[Lynlw]

Very good point about the size issue more than likely improving over time, and yes it is more than just fitting it in, there has to be adequate hemodynamic response. I tracked down that minimum size I'd seen - in a Lars Svensson - Cleveland webchat in May, he said that a 21 mm Edwards Magna was probably too small for percutaneous at this time (current approved technology).

I have not seen the trial exclusion criteria, but unless I'm mistaken, I think that would only apply to native valves anyway, since the trial hasn't included percutaneous in bioprosthethic valves yet or even percutaneous in native bicuspid. Obviously, that's expected to change though, and I would guess it's already being done in Europe? So much to learn...

Interesting what the doctors said about native versus bioprosthetic valves...makes a lot of sense, back to Norm's point.

The reason the trial criteria included too small or too big valve patients was (at that time at least-when trial started) there weren't valves available in those sizes yet, so even tho the US trials were talking about native valves IMO that applied to tissue valves right now too, if they don't have the bigger or smaller size valves yet..

But yes they have already done valve in tissue valves in other countries, for Aortic percutaneous, and they have placed TAVI valves in other TAVI valves.
but Pulmonary percutaneous valves (Melody) in the US (and everywhere else) are done in valves/conduits that have already been replaced. They have already placed percutaneous pulmonary valves inside other percutaneous valves in the US and other countries too since they are the first percutaneous valves and have been around the longest, my thoughts are the other valves will probably follow the same path as far as improvements made sizes available.

 

[ElectLive]

Found a few articles coverings some of these issues, will include the "highlights" in this post, the articles are fairly long:

http://content.onlinejacc.org/cgi/content/full/55/2/97

http://circ.ahajournals.org/content/121/16/1848.full

"A THV implanted within a smaller surgical prosthesis can be expected to function suboptimally with increased transvalvular gradient, impaired leaflet coaptation, and reduced durability. The acceptable boundaries of underexpansion are undefined. Residual stenosis and limited durability may be acceptable in some patients with no alternatives but unacceptable in others. For example, the smallest currently available 23-mm SAPIEN THV appears to result in acceptable hemodynamic performance when implanted within a 23-mm bioprosthetic surgical valve with an internal diameter of 19 mm. However, implantation of this THV within a 21-mm surgical valve can be anticipated to result in a significant residual gradient, whereas implantation within a 19-mm prosthesis might result in severe stenosis. The potential for valve-in-valve therapy for late bioprosthetic failure may arguably be an additional reason for maximizing the size of an initial surgical or transcatheter valve. Newer THVs with smaller and larger diameters are becoming available and will likely extend the range of surgical bioprostheses amenable to valve-in-valve therapy."


"...there are some features that make this option attractive. The original bioprosthesis gives a highly visible target for placement of the new implant and offers a scaffold that immediately grips the CoreValve (Medtronic) as it is deployed, facilitating accurate placement of the device. Additionally, the uniform circular sewing ring allows for equal and symmetrical expansion of the skirt of the valve such that paraprosthetic AR is unlikely.

Several other aspects of this technique warrant discussion in further detail. Firstly, in native cases, measurement of the aortic annulus is critical to the success of the procedure. In the cases presented, however, it is simply necessary to know the valvular diameter of the previously implanted valve. A 26-mm CoreValve (Medtronic) will be the correct option in the vast majority of cases. It is important to note that internal diameters of <21 mm in the aortic valve implant would be insufficient for CoreValve (Medtronic) implantation, exceeding its design limitations, with a resultant gradient and possible malfunction of the leaflets resulting in a suboptimal outcome...

...the resulting internal diameter of the valve decreases with every deployment. This "Russian doll" effect might become more evident in light of successful procedures within both bioprosthetic and TAVI replacements and might serve as an additional driver for the development of valves with smaller diameters."