New St. Jude's Trifecta valve

[jennifer]

First of all, let me say how helpful this group has been for me! I have read more practical advice and insight on here than the last 2 months of "surfing the 'net". I am very new to all of this, I learned recently that I need an aortic valve replacement and repair of an aortic aneurysm. My surgeon agreed (reluctantly) to go with tissue because I did not want to do ACT. (I am very active with 5 kids and just don't feel ready to do lifetime ACT at 38). He said he wanted to use the St. Jude's Trifecta, but at that time it was not FDA approved. Well, it was approved for U.S. launch on Wednesday. Yeah! My doctor mentioned its superior hemodynamics, but I'm hoping to buy a few years on the re-op, too.

I do have a question about "extra" procedures during OHS. Apparently, the MRI showed that I have a hemangioma on my liver. From what I've read, they may never be problematic and aren't uncommon. However, I would like it removed while he's in "the neighborhood." I don't have another appointment before surgery, but I plan to ask about it in the next two weeks. I was just wondering if anyone else has had a similar experience. Thanks so much!

 

[pekster11]

Hi Jennifer,
I am in a v similar position to yourself.
I'm 37 and it seems as though i will need an aortic valve replacement with a root repair in the next few years. I have been told due to my age, a mechanical valve is best. I have, however, never heard of the St Jude's trifecta valve (which I assume is a tissue valve). Any idea on the expected lifetime of this valve in a young patient ?

 

[jennifer]

Hi pekster11,
Thanks for your response. I have looked at the website www.sjm.com and read several times the information on the St. Jude's valve. It just says that it is "built for durability" and has a titanium-reinforced stent. It is covered with pericardial tissue so ACT is not needed. For me personally, my decision was based on the fact that my kids will be grown and (presumably) out of the house in 10 years. If I need a re-op at that time (although I'm hoping for 15 years), I may consider mechanical. Of course, alternatives such as percutaneous valve replacement may have advanced by then. If I come across any other info. about the valve, I'll pass it along. It's great that you are getting a "head start" on getting as much info. about surgery as you can!

 

[LeakyUK]

Jennifer, at 58 I am firmly in the NEVER again camp, so will go mechanical, I have checked out the ACT options and am not too bothered. I am no expert, but I cannot imagine Liver surgery done at the same time. The heart surgeon will not be a liver expert, and you will be having enough things to cope with. Extra procedures at valve replacement would be anuerism or by-pass which can be done at the same time.

 

[kfay]

Jennifer, Good for you for doing your homework and making a choice that works for you and that you are comfortable with. I have to agree with Leaky, there is no way they will touch your liver "while he's in the neighborhood"! Heart surgery is not like having your tonsils out, it is a major surgery and to just throw in surgery on your liver at the same time just isn't going to happen.

Good luck with your new valve. I have the St. Jude Biocor.

Kim

 

[jennifer]

Thanks for the replies! I had to laugh when I read them, thinking "Well, when you put it THAT way...". It was a little bit of wishful thinking. I guess I just wanted to kill two birds with one stone and have one less thing to "keep an eye on" the rest of my life. Thanks again for the insight!

 

[Bryan B]

I have to agree with the others on doing other procedures. The liver is not really in the heart surgeon's neighborhood and not his specialty. I believe (I might be wrong) that liver surgery would require an abdominal incision. I have heard they are very painful too so I couldn't imagine dealing with a cracked sternum and an abdominal incision at the same time.

The trifecta valve sounds promising. I just had my 2nd surgery (first was Ross Procedure) and elected to go with a tissue valve. Me and my surgeon agreed on the mosaic freestyle valve with root because I was also getting my root and ascending aorta replaced. Once he got in there my root was so big the freestyle valve wouldn't fit so he went with the Edwards pericardial bovine valve. I am 50 so assuming I am still around when it wears out I am looking at another surgery and will be kind of in the grey zone for another tissue valve lasting the rest of my life. Hopefully percutaneous valve replacement will have advanced to the point that it will be done routinely (my surgeon thinks it will) but I didn't base my decision on that but more on my lifestyle. I was on warfarin for 3 months when I had A-Flutter and found it to be no big deal but me and my surgeon agreed that a tissue valve would be best for me. There may be advancements in mechanical valves that may lead to not having to take anticoagulation meds and also anticoagulation meds that do not require monitoring. Who knows what will be available down the road.

 

[lance]

Hello Jennifer
How long has this new SJM valve been available?
How long has it been tested?
Have you contacted SJM directly (not a phone call) something written?
Eleven years ago SJM launched it's "new" silzone-coated valve. It was recalled because of complications including death and was recalled. It was tested on 10 sheep, 5 died and was released to the public. The FDA never approved the coating that was applied to an already approved valve. Unfortunately I have one.
There was world-wide litigation against SJM.
The US case was lost because unless SJM spoke/wrote communicated directly with recipients a contract did not exist.
Were I in your position I would look a little deeper into the subject and get something in writing about its reliability and testing procedures.
This is meant to inform, not alarm. How I wish I had known better at the time.

 

[jennifer]

Lance,
Thanks for the good advice. Most of my info. about the valve is from the St. Jude's website, perhaps not the most objective source. My surgeon did say that he helped develop the valve and it has been used in other countries for several years. However, I will do a little more research. Thanks!

 

[EclipseDS]

Jennifer, thanks for starting this topic. Not to take anything away from the OP but I'm surprise how little public information there is for SJ Trifecta. My turn to go under the knife will be several weeks from now and at 37, I'm leaning towards mechanical valve, but this new valve is very promising, at least on paper. Other than "improved durability", I can't find any hard numbers to help me decide if it's good for me or not. While being on coumadin for life sounds misserable, the thought of getting another OHS in a few years is nerve-wracking.

 

[Lynlw]

Jennifer, thanks for starting this topic. Not to take anything away from the OP but I'm surprise how little public information there is for SJ Trifecta. My turn to go under the knife will be several weeks from now and at 37, I'm leaning towards mechanical valve, but this new valve is very promising, at least on paper. Other than "improved durability", I can't find any hard numbers to help me decide if it's good for me or not. While being on coumadin for life sounds misserable, the thought of getting another OHS in a few years is nerve-wracking.

I think part of the reason there isn't much info out there is, I think the earliest they started using them in trials, was the end of 07, beginning of 08 (world wide, not just US). So it hasn't been around long enough to have enough data and write up the studies. Often by the time something is apprroved in the US there already is some results from other Countries, so its easier to find a little more info.

 

[normofthenorth]

This Trifecta valve reminds me of the ATS 3f valve, which is made from horse pericardium. The ATS is discussed at http://www.atsmedical.com/Physicians.aspx?id=2530 . (And NB that ATS is now owned by Medtronics.)

Both valves are apparently based on an essentially tubular form that collapses (to close) around 3 fixed points. In the ATS, the fixed points seem to be attached to the surrounding tissue; in the SJ, they are supported by the internal titanium frame.

One of our posters here recently got the ATS 3f, and it led to a bunch of jokes about race horses, stallions, etc. Last I noticed, he was happy with it.

As Lyn indicated, a valve has to be in reasonably widespread use for a long time to build up a record that can establish solid statistical evidence of durability. So there's a natural conflict or tradeoff between being the "first kid on the block" to get the model that's "new and improved", and getting one that's "tried and tested" to last a long time. Maybe some day, they'll work out (and verify) some kind of accelerated degradation apparatus, or model! But by then, they may have figured out the mechanisms of degradation well enough to control or virtually eliminate them, which would be even better!

 

[Eclectus45]

Gday Jennifer,
I had a St Jude mitral valve implant aged 39. In my case there was no possibility of researching the pros and cons, I had a quick chat with the surgeon and he said there's pig ones and mechanical ones.He said you should take the latter cos of your age.
No mention was made of the incessant clicking in my head I'd be suffering, which has brought me to tears of frustration and the brink of suicide many times. I wanted to cut it out or pierce my eardrums, I even talked to my specialist about another op. I'm on Endep now, but even as I type this I can hear it loud and clear resonating up my throat.
It's a bit quieter if I turn my head to the right and I always sleep on my right side.
So anyhoo I can't vouch for anyone else, and maybe the aorta one you talk about is different altogether, but at least I'd ask around about the noise it'll make. I read the other post "my choice my regret" but I can't bring myself to reply. Good luck and I hope this has helped some.

 

[jennifer]

Eclectus45,
Thanks for sharing your thoughts and your experience. I can't imagine how distressing that would be to hear the incessant clicking, and I'm hoping that is only an issue for mechanical valves. I can only say that I have learned that what we see (or in this case, hear) is what we are focusing on. I have read others on this forum who have said they struggled with that and eventually were able to "tune it out" or use it as a reminder that their heart is working properly. I also think that a therapist can help us change our thinking patterns. I believe this because I am a therapist and because I have been helped by one myself. Personally, another help for me is my faith in God. I am facing surgery tomorrow morning and it gives me peace to know that everything will work out like it's supposed to. Whether I get through this OK or not doesn't really depend on the hospital, valve or surgeon. That's not to say that I'm not a little stressed, though! As EclipseDS mentioned, I am find "nerve-wrecking" the thought of doing this again in 10 if my tissue valve fails, and I haven't even done it the first time yet! However, all I can do is make the most of everyday, which is a theme that I have picked up from this wonderful group. Again, thanks for your input.

 

[Lynlw]

Jennifer, You'll be in my thoughts tomorrow. Will someone be able to update us before you can get online? If it helps, with your nerves, obviously this isn't something to count on, but hopefully by the time you need this valve replaced, they will be able to do them in the cath lab. I think you have a great attitude and really do believe that helps alot in the recovery process.
Lyn

ps With 5 kids, Happy Mother's Day! Hopefully, you will be so busy enjoying today with your family you won't even have time to worry.
How old are your kids? I'll keep your husband and whoever is helping with the kids in my thoughts this week too

 

[EclipseDS]

Eclectus45, I hope it will get better for you sooner rather than later. It is a real concern and I have to read up more about the noise a replacement valve makes.

Jennifer, I wish you well, and I have to say, I admire your faith. Sending you my possitive thoughts and praying for your speedy recovery.

-Eli

 

[jennifer]

Thanks so much for the well-wishes! I'm back, and on "this side of the mountain", as we say around here! My surgery went well, with a couple of minor complications. I needed a transfusion of two units of blood and one unit of platelets. I also had a post-op episode of SVT when my HR got up to 266, which was a little scary. I am home now, one week later, and resting. Lyn, my kids are 12, 11, 10, 9 and 7, so they are able to do a lot for themselves. Plus, we have had a LOT of help from family and friends. I'm sticking to crew-neck shirts right now because I really don't think my kids could handle the way the scar looks, but gradually I am talking about it with them. I have thought about you this week, and your perspective as a mother of a patient. You must have nerves of steel! I'm 38, and I know this has been a struggle for my mother. I can't imagine the road you have traveled with Justin. Anyway, thanks again for all the encouragement! I'm off to review the sticky on "post-op" advice!

 

[Eclectus45]

Gday EclipseDS thanks for your reply. I've been trying to find a site like this for a long time and I hope my reply to Jennifer wasn't ill timed, but I just really wanted that everyone knew to ask questions before committing, forewarned is forearmed or some such thing. Mate I'm never going to get used to this noise.I've perfect pitch and I play guitar, I'm real sensitive to sound and i remember after surgery the guy doing the angiogram(?) said mine makes an unusual sound, and the tissue ones don't make a sound at all and u don't even need warfarin after 3months (so I'm told),so I'd have chosen one of them if I knew.
Never mind, I got great family and wonderful friends, and the whales will be migrating North in a few weeks so there's that to look forwrad to!