TAVR vs AVR

[BionicBuddy]

Thanks again Lyn.

I guess what I'm looking for, is if there are any studies that are ongoing with BAV SAS patients who are less than 70 years old, who are having/ or have had TAVIs. The Partner I and II trials have BAV as an exclusion criteria. The only info I could come up with is that it probably isn't the best idea do to TAVIs in people with BAVs yet, as seen in this study http://www.ncbi.nlm.nih.gov/pubmed/22459301 and in this study http://www.ncbi.nlm.nih.gov/pubmed/21087746

That's why I was wondering about all of the European activity going on (primarily Germany) regarding TAVIs, and did they have the same exclusion criteria or not?

I recall our cardiologist saying 7 years ago, that when my husband would need an AVR in about 10 - 15 years, that TAVIs would be commonplace by then.

Before we see 2 different cardiologists in the next few months, I just wanted to bring myself up to date regarding the latest information.

The hard part for me (us), is having read the echo that was hot off the press 4 weeks ago, prior to having an appointment with the cardiologist(s), and having so many questions with so many unknowns right now.

 

[Lynlw]

Thanks again Lyn.

I guess what I'm looking for, is if there are any studies that are ongoing with BAV SAS patients who are less than 70 years old, who are having/ or have had TAVIs. The Partner I and II trials have BAV as an exclusion criteria. The only info I could come up with is that it probably isn't the best idea do to TAVIs in people with BAVs yet, as seen in this study http://www.ncbi.nlm.nih.gov/pubmed/22459301 and in this study http://www.ncbi.nlm.nih.gov/pubmed/21087746

That's why I was wondering about all of the European activity going on (primarily Germany) regarding TAVIs, and did they have the same exclusion criteria or not?

I recall our cardiologist saying 7 years ago, that when my husband would need an AVR in about 10 - 15 years, that TAVIs would be commonplace by then.

Before we see 2 different cardiologists in the next few months, I just wanted to bring myself up to date regarding the latest information.

The hard part for me (us), is having read the echo that was hot off the press 4 weeks ago, prior to having an appointment with the cardiologist(s), and having so many questions with so many unknowns right now.

i I'll try to respond later, since t is kind of long, But I was wonderring if you've thought about starting a thread somewhere, introducng yourself and husband , and a little of what has been going on,history age, ect and questions you guys have.. I know You (well we) can read thru different threads you've posted in and get an idea of what is going on, but it might be a little easier to get the answers in 1 thread, especially since many people dont read older threads that have been brought back up.

but the quick answer would probably (MY thoughts) be that since TAVI has only been around about 10 years now and the pulm percutaneous only a couple years longer, right now, most of the trials, work, money is going into making and improving the percutaneous valves and delivery systems, and even trasfemeral or transapial and need the information on a small group of people that have "normal" valves, so if something isnt right they dont have to figure out if it has anything to do with the fact the valve replaced was bicuspid. or if it was a fault with the valve itself. ( to get the valves approved to start with) most of the trials started with the oldest people who could not have surgery, since valve replacements have great stats so why risk a healthier people who would do great with tradional surgery even if it is a longer/tougherrecovery, then they have been approving trials for healthier (and healthier) groups with improved valves (in smaller and larger sizes0 and improved delivery sysmtem, smaller, repositional etc. My guess is after that happens then they will start trying other things, like BAV patients etc
Since a couple TAVI valves already have been approved a few years in Europe they do not have to follow the criteria as tightly as valves still going thru trials and hoping to get approved

 

[ElectLive]

...I was wondering about all of the European activity going on (primarily Germany) regarding TAVIs, and did they have the same exclusion criteria or not?.

It appears that BAV is also a general exclusion factor in Europe, and Germany specifically. They don't have "guidelines" per se as the US already does, but position statements are available for Europe as a whole (http://ejcts.oxfordjournals.org/content/34/1/1.full.pdf) as well as some of the individual nations like Germany. I would assume "off-label" procedures are certainly happening there, likely to a higher degree, but am not aware of much study evidence yet. So, if you find any, please post!

You know, on one hand, for higher risk patients, your cardiologist might just be right within the next 8 years. But for low-risk patients, commonplace is not so easy, there is an extremely successful method for aortic valve replacement (standard surgery) that TAVI will have to beat out...i.e. approach clinical noninferiority. Forgive me for being nosy, but given your husband's age and what sounded to be good physical condition that you've mentioned before, he doesn't sound very high risk. Are you researching TAVI as a potential first surgery or second? In other words, the bicuspid valve problem goes away for a second surgery since a TAVI valve will likely deploy very well someday in a bioprosthetic valve.

 

[ElectLive]

But I was wonderring if you've thought about starting a thread somewhere, introducng yourself and husband , and a little of what has been going on,history age, ect and questions you guys have.. I know You (well we) can read thru different threads you've posted in and get an idea of what is going on, but it might be a little easier to get the answers in 1 thread, especially since many people dont read older threads that have been brought back up.

Lyn - I was thinking the same thing...glad you mentioned (as I was typing )

 

[BionicBuddy]

Great idea. I'll do that. I guess I just didn't want to come off as a whiner since I'm only the (terrified) spouse, not the patient.

 

[Lynlw]

Lyn - I was thinking the same thing...glad you mentioned (as I was typing )

Since im being Bossy in this thread I thought I'd keep it going and thank you for the links you gave for the articles you quoted. It makes it so much easier for others, well me at least, to read the rest of the article /study with the links right there instead of googling..and i guess im lazy :tongue2:

 

[ElectLive]

You know, I probably shouldn't admit this, Lyn, but I did find the official Position Statement for Germany too, but chose not to provide the link. I wonder if anyone can guess why: http://leitlinien.dgk.org/images/pdf/leitlinien_volltext/2009-06_aortenklappen.pdf :cool2:

Now, I didn't give up that easily, of course. I did find a way to translate. But it only worked on about 3 of every 4 words or so. So, well, I just sort of decided maybe I should just not post a link for a change... :thumbup:

 

[normofthenorth]

Great thread, and major thanks to EL & Lyn for all the work!

BicuspidBuddy, I think there were quite a few of us here who had AS & ARegurg with BAVs but no symptoms heading into surgery. You can check my long "blog" thread for details (search for "Norm's story"), but I postponed my AVR longer than my cardio wanted, and finally had two minor bouts of SOB, my only symptoms. Before that, I'd been extremely active, though my second Achilles Tendon rupture (playing competitive court volleyball) about a year pre-AVR sidelined me from my MOST strenuous sports for most of that year. But I had returned to frequent and active urban cycling for some time pre-op. (When I first returned to aggressive cycling after the AT rupture, I was so out of shape from the immobilization and rehab that I thought I might be getting AV symptoms, but they resolved as I regained fitness.)

 

[BionicBuddy]

I think there were quite a few of us here who had AS & ARegurg with BAVs but no symptoms heading into surgery. You can check my long "blog" thread for details (search for "Norm's story"), but I postponed my AVR longer than my cardio wanted . . .

Hi Norm,

I couldn't find 'norm's story'. I found your long post-operative experience entitled 'norm's story . . . .", but I couldn't find your pre-operative experience with echo measurements, etc. If it's in a blog, for some reason this site states that I do not have permission to view blogs. How do I read your pre-op story?

Thanks

 

[normofthenorth]

BicuspidBuddy, I think you found the long blog-like thread I was referring to. It was all posted post-op, but I think it includes my pre-op experience. (Apologies if not!)

Meanwhile, you've got most of the story already. My AV worked incredibly well in volleyball (with a bunch of 20- and 30-somethings, including HOURS of 2-on-2!) & cycling and skiing big mountains fast and running up stairs &c. &c. All this while my echo numbers were going down the tubes. I resisted surgery for around a year after my cardio wld have sent me in (my surgeon was more patient), until I'd had 2 minor bouts of Shortness of Breath -- 1 of them after running up two LONG flights of stairs from a very deep subway station then walking fast to home.

I think I also retold the story my surgeon told me about the marathon runner who postponed her AVR until the day after an important marathon -- and then he couldn't believe how awful her native AV looked! He said mine was "right up there" with hers...

That doesn't mean that everybody shld wait for symptoms. There are psychological benefits of doing so (IMHO), but physical risks/costs.

 

[Bryan B]

This article doesn't really add much to what has already been said, it's more bragging about my surgeon being involved in the trials lol. BTW they are running the clinical trials with the Medtronic CoreValve, not the Edwards Sapien. When I had my most recent surgery I was undecided about whether to go with a mechanical valve or a tissue valve at age 50. While Dr. Hughes did not try to sway my decision (he suggested SJ mech or Medtrontic Freestyle tissue but would implant whatever I chose), he did discuss the ongoing trials that he is part of. In his opinion he thought that if I got the normal life expectancy from my Edwards bovine pericardial tissue valve (my aortic root diameter was too large for the Freestyle) that percutaneous valve replacement should be an option for me by that point, especially because by that point I might well fit into the "intermediate group" due to it being my 3rd surgery. He added there were no guarantees but that it was just his opinion based on the progress they have made since the trials have started. That is my surgeon in the top right picture performing the procedure. The dude is a rock star and only 41 years old, so he should still be around to replace my valve next time. :biggrin2:

http://www.dukehealth.org/health_li...e-tavi-trial-showing-impressive-early-results

 

[Lynlw]

Since there are a few updates in this thread, even tho I started a new one, http://www.valvereplacement.org/for...e-Sapien-TAVR-for-high-risk-operable-patients i thought I'd add it here too.

Yesterday (6/13/12) while it is NOT approved YET, the FDA advisors voted and reccomended the Sapien valve be approved for High risk (but operable) patients based on the 1 year data from the PARTNER trials for the high risk arm.

Th article also mentioned, "Approval of this indication would also usher in the company's transapical delivery system, allowing the device to be deployed in patients whose femoral artery is not suited to transcatheter delivery of the percutaneous valve" which would be good since it would help even more patients

http://www.theheart.org/article/141...medium=email&utm_source=20120613_breakingNews

Also while not having anything to do with approvals, I thought this was an interesting article about 1 patient who they were waiting for them (TAVI) to be available (trials) since he would be a great candidate and wouldnt be able to have OHS but needed a new Aortic valve, http://blogs.theheart.org/melissa-w...of-tavi-flows-with-frustration-milk-and-honey

 

[normofthenorth]

And this just in, suggesting that TAVI might NOT be ready for prime time for operable patients -- partly because it seems to be much more $$$ than OHS/AVR (to my great surprise -- startup or novelty costs??):
http://m.theheart.org/article/14321...20120802_EN_Heartwire&utm_campaign=newsletter
That link is from my iPod. If it causes problems on a big screen, replace the m. with www.

 

[Paleowoman]

The one year mortality rate at 25% and 20% seems pretty high too - though they're talking about inoperable patients.

And this just in, suggesting that TAVI might NOT be ready for prime time for operable patients -- partly because it seems to be much more $$$ than OHS/AVR (to my great surprise -- startup or novelty costs??):
http://m.theheart.org/article/14321...20120802_EN_Heartwire&utm_campaign=newsletter
That link is from my iPod. If it causes problems on a big screen, replace the m. with www.

 

[Sarah_Louise]

And this just in, suggesting that TAVI might NOT be ready for prime time for operable patients -- partly because it seems to be much more $$$ than OHS/AVR (to my great surprise -- startup or novelty costs??):
http://m.theheart.org/article/14321...20120802_EN_Heartwire&utm_campaign=newsletter
That link is from my iPod. If it causes problems on a big screen, replace the m. with www.

As you no i'm waiting for a TPVR and i had to apply to my government for funding as it wasn't available on the NHS, my cardiac nurse told me it is more expensive than normal OHS! i'd need about £80,000 for the full procedure :O and i think my cardiologist said it was about £25,000 for the valve alone!!!
Love Sarah xxxx

 

[normofthenorth]

The one year mortality rate at 25% and 20% seems pretty high too - though they're talking about inoperable patients.

I don't think those numbers are just for inoperable patients, but for the mix of patients (in UK and France) who got the procedure. I think.

 

[Paleowoman]

I've tried to find out and as far as I know TAVI has only been carried out so far on 'inoperable' patients in the UK and France. Have a look through at this UK TAVI website: http://taviforum.org/index.php?option=com_content&view=category&layout=blog&id=2&Itemid=7 All the entries seem to refer to inoperabe patients. But a 20% and 25% mortality in "operable" patients would be a terrible risk - I mean the current mortality for AVR is about 1% to 3%.

I don't think those numbers are just for inoperable patients, but for the mix of patients (in UK and France) who got the procedure. I think.

 

[normofthenorth]

OK you may be right. For sure the operable patients in the PARTNERS trial were just barely operable -- i.e. high risk with multiple comorbidities. That group doesn't have 1% op risk. . .

 

[Lynlw]

The one year mortality rate at 25% and 20% seems pretty high too - though they're talking about inoperable patients.

I believe the numbers you are talking about are also the stats for the transapical approach patients, which pretty much are the worst of the worst gong into it, since they can't use the femoral approach, which usually means they have alot of issues with plaque, small weak bood vessels, etc.

I'm not sure I would say this opinion means the procedure is "not ready for prime time", since it seems they mostly take cost into consideration and and not even the much easier recovery, less time in hospital and much smaller incisions so less chances of infection that can be HUGE added medical costs, less time off work AND it is just one groups opinion. Maybe I think differently but not ready for prime time to me would be more related to people dont do well, results arent as good as surgery, etc not cost.

I'm sure as time goes on the cost will decrease, already in the US at least, most people I know of who are eligble for the Melody pulmonary valve instead of having yet another OHS to replace their tissue valve, arent having many if any problems getting the cath valve approved my GUESS is as other cath valves get approved and more people get them, the cost will go down and they will follow the same path the Melody valve has as far as being approved for lower risk patients. Altho often in the US once something is FDA approved for a group of people, IF the doctors reccomnd something it will be approved by insurance, it MIGHT take a call or 2 and some hoops to jump thru, especially in the beginning, but usually approved. Actually even some things are paid for even if they are still classified as experimental, if it shows it can be a benefit to the patient and might even end up costing less. Im sure the fact there will be quite a few centers across the Us doing them so many centers will be "In network" and not alot of travelling to get to a center, like oftne can happen for New" surgeries or procedures will make it a little easier too. For example, when Justin was a baby, only a handlful of hospitals in the US (or world) could do some of the newer more complex CHD surgeries, so travel and getting things approved out of network, often ran up the cost and made the parents/docotrs have to work hard with insurance to even get them aproved. Luckily there are already close to 70 cneters in the US canada who are qualified, have the equipment for percutaneous valve placement.

Another reason the cost COULD be higher in the beginning, specially for something like this, is the hospitals might have to spend alot of money like building the hybrid, cath/OR rooms that are reccoemnded if possible for center wanting to do them, and Im sure that money has to come from somewhere.

Not to mention this article is taking about 1st time valve patients, so it will be interesting to see what they will consider cost effective for REDOS, which really for the most part anyone here right now is taking into consideration when making a valve choice, and not for the most part thinking about it for a first time valve.

I am NOT saying I think they are perfect now and everyone should get one who wants them yet, just that cost wouldnt be as important to me as other things when they are being approved for more and more groups of people.

 

[Lynlw]

OK you may be right. For sure the operable patients in the PARTNERS trial were just barely operable -- i.e. high risk with multiple comorbidities. That group doesn't have 1% op risk. . .

Since to be considerred "high risk but operable" in the PARTNER trial, you had to have a

"1.Patients must have co-morbidities such that the surgeon and cardiologist Co-PIs concur that the predicted risk of operative mortality is ≥15% and/or a minimum STS score of 10" so there were people with alot worse risks, but still fall into the high risk operable catagory going into the surgery/procedure. and that is just the OR/short term not year out, that would fall into the numbers

Altho the PARTNER rsults include all the patients included in a learning curve, for the most part the people at the end of the trial had less problems than the begining from what I remeber rom varius lectures online.and even since that started there have been quite a few improvements to the valves and cath device itself.

Not really related but Interstingly to me, I was surprised for AVR that "high risk" was still relatively low at 15% compared to some other heart surgeries. So What you would consider barely operable, could be considerred wonderful odds for other surgeries.
There were a few times i woud have been thrilled to be given 85% chance of doing fine. Altho I never asked the risk his last couple OHS had, since it didnt really matter since there werent many choices if he (we) wanted to live. But to me at least it makes me think how great it is that a surgery like this has such relatively great outcomes even for the highest risks patients.