New St. Jude valve

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greggo32

This concerns the new St. Jude Regent Heart Valve. Given that the FDA just approved the use of it in the U.S., does anybody know if the product is available in the U.S. It has been used in Canada and Europe since 1999 and I am wondering if there is inventory and I am also wondering if the U.S. cardiovascular surgeons are ready to go with them. Let's see if anybody out there knows what's up!

Greg
 
Hi Greg,

Welcome to the site. Hopefully you will get some responses from our family in Canada and Europe. I have read about this valve, but don't think I have read of any members on the site that have received one.

I was also wondering...St Judes has a fantastic web site, and also has great customer service if you call them, So, my question is, have you tried to contact them directly for a response to your question?

If not, their web site is:

http://www.sjm.com/

Looking forward to hearing back from you with the information that you find,

Rob
 
To Janie and Rob

To Janie and Rob

I didn't mean to heat up the site! I will be undergoing a valve replacement soon and I am trying to decide the best option. I had an aortic valve repair at the Cleveland Clinic in 1992 at age 25. I am 9 and 1/2 years post op; however, the damn thing hasn't lasted! So, I am deciding between a homograft or a St. Jude mechanical valve. I was excited to see a new product by St. Jude and as you all know we hope for the best. I am having a tough time with my decision and have been reaching out for suggestions from REAL people not just the professionals. Cleveland is hot on the homografts and Mount Sinai in Miami will only do the St. Jude valve. My cardiologist wants me to take the position of Cleveland as he holds Dr. Cosgrove in high regard and Cosgrove did my repair. Yet, my Dad (physician of 50 years) called a research cardiologist (at Cedars Sinai in L.A) and he said that he would only go with a St. Jude! I am trying to stay empowered in the decision making process; however, I realize there are no guarantees with any decision.

Thanks for addressing the point and best to both of you..
 
Hi Greg-

From a practical point of view, let me mention a couple of things that you might want to take into consideration.

This is going to be your second heart valve surgery. If you were to go with a homograft valve, you will probably be facing another valve surgery at some time in the future. I think that's pretty much a given. The only differential would be at what point would this be necessary.

If you go with a mechanical valve, you have a high percentage that your valve will last a lifetime.

My husband has 2 mechanicals. His aortic valve is a Bjork-Shiley which has been in place for 25 years. His mitral is a St. Jude (non-silzone) which was implanted 2 years ago. He has also just had a repair on the mitral for a paravalvular leak. The St. Jude valve has always been in perfect working order, the leak was around the stitching and could have come lose when he had one of several faints soon after the initial mitral valve surgery, due to afib. He now has a pacemaker to control the afib.

I can tell you from his experiences that the third heart valve surgery was technically difficult due to heavy scar tissue and adhesions. Because it was his third heart surgery, it was very difficult to get the cardiologist to agree to the operation. The risk factors change with a higher number of surgeries, and the risk to benefit ratio changes. As a result he was much sicker before the surgery was agreed to. He lost a lot of muscle tone during his period of sickness and it has been a difficult process to get himself in shape again. He has a lot of residual pain from scar tissue.

He is now facing a possible incisional hernia repair surgery which is the result of having his chest opened up on two occasions. His third heart surgery was through the side, heart port method.

Each time this operation is done, the problems accumulate and that has to be factored into your decision. You should also think about the chance that you will be older and possibly sicker when you would have to have a third surgery.

Being on Coumadin, for my husband, has been no big deal. He's on a lot of medication anyway, so what's one or two more pills. He gets tested monthly unless the INR is out of range. He's never had a major bleeding incident and when he was younger, he was very active.

Just some food for thought. Best wishes.
 
Just a comment.....

My husband is a General Contractor, in New England, where we experience all sorts of weather conditions.

There are always "new and improved" building materials coming out. However, many of these do not withstand the test of time, and fail in 5, 10 or 15 years.

Therefor, when it comes to something as important as a heart valve, go with the one that has withstood the test of time, and has performed the best, out of all possible choices. Although the decision is difficult, err on the conservative side if you can. It's your heart....and your life.

Best of luck!

Marybeth
 
Janie, what happened to your post? yours' and Robs rebuttle are gone. I thought you and Rob made some excellent comments regarding this subject.
 
Go St.Jude!

Go St.Jude!

Hi Greg ,I am a "real" person and an old 50 year MD like your Dad. I am now three and a half years post op St. Jude mitral valve replacement with a mechanical. Nancy above, as usual ,gave superb advice and I am with her. Go St. Jude!
 
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Hi Phil,

In answer to above post, Billy, Janie and I decided that our conversation was not heading in a postive direction to assist Greg find answers to his original question. Therefore, we deleted our posts.


Rob
 
hi greg!
everyone here is right. those who say that mechanicals will be the most practical and long-lasting are very right. others who say that the tissue or homograft is the way to go (technology will have something in a few years when it's time to redo these) are right too.
as far as coumadin goes, many people are afraid of it and will go to great lengths to avoid it. those who take it, though, don't seem to mind it at all.
my dad has a st. jude's and takes coumadin and leads an active lifestyle (he's only 68). no complaints from him!
my husband, on the other hand, is 49 and wanted no part of coumadin (our lifestyle, etc)
so he opted for the ross procedure. now i read all these stories about rp's failing, etc. and to be honest, it really spooks me.
it's a very personal thing, this valve selection. there are no guarantees. you have to make a choice you will be comfortable with, regardless of how long it actually does end up lasting (which is, hopefully, the long end of the statistical range).
i think i 've learned that there really is no right or wrong answer to this dilemna. it is a lifesaving surgery and is designed to do just that. if the valve lasts as long as it's said to, i would consider that to be one of the lucky ones.
don't mean to sound somber, just realistic and honest. please let us know what you decide.
good luck in your decision making. wishing you all the best,
sylvia
 
Hi Greg again-

I think the main situation you are facing is that this is your second heart valve surgery. If it were your first, then there are many excellent valves to consider. But being your second, in my humble opinion, it would be the very best for you to avoid a third surgery some time down the road, if you can. Third, fourth and fifth surgeries are doable, if you have an excellent surgeon and your heart is in good shape except for the valve, but they take a toll on the body and I'll mention again that scar tissue and adhesions have a cumulative effect on the outcome of the surgery. There are other ancillary things to consider which aren't discussed too much, for instance, the breathing tubes which are inserted into your throat can sometimes leave damage. My husband's voice sounds like Aldo Ray's (if anyone here is old enough to remember that actor), and there are also other holes, with scar tissue from the various drains, etc. that are necessary. In addition, having to face this surgery again when you are much older and possibly not in good health is not a good idea.

Even if there were to be some technological breakthrough, there is no guarantee that it would come when you would need it.

Sorry to sound so pushy, but I've been through bundles with Joe and hope bring you some info. from an old "warrior".

These decisions are so very tough. I wish you well.
 
I want to thank everyone for the honest and technical feedback. I truly get the sense that you guys are a bunch of intelligent, caring, and sometimes brutally honest folks! I feel very lucky to have stumbled onto this site. I am headed to Mount Sinai in N.Y.C. for a 3rd opinion on my aortic valve. I am going to see a cardiologist by the name of Dr. Valentine Fuster. My old neighbor from N.Y is a colleague of his. My dad called the surgeon at Mt. Sinai (Miami Beach) and he stated that the St. Jude Regent is for folks with smaller valves and that it wouldn't make much difference with me. It is looking more and more that I will go with the St. Jude carbomedics valve. Why did I have to to have a faulty gene? I really wished the original repair would have held longer. I remember having a dream (years ago) that a surgeon told me that I needed surgery again. I remember that I woke up agitated and on the verge of tears. Well, that day has come and I have a variety of feelings-numb, confused, agitated, sad, and fatalistic. Anyway, I am going to go knock off my neighobor and harvest a fresh valve. I will install it myself!!!
 
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I know how frustrating it is to be facing another surgery. When my cardio told me my porcine valve of 11 yrs was leaking I just broke down and cried.
I felt betrayed since the surgeon had mentioned that he had seen them last 15+ yrs and I was so certain mine would be one of those. I just was not ready to go thru that again, and I had no symptoms, so I was so shocked to hear that I needed replacement and that I would get mechanical.
In 89 I figured the technology would help me so I wouldn't need mechanical when I needed another valve. But technology doesn't always happen as fast as we want. So in 00, my option was the same as in 89, mechanical. I got the sulzer carbomedics valve, one of the few on this site without a st. judes,( wonder why?)
After awhile the anger subsides and you know that the surgery is what you need to do. You will come thru it fine. I actually got out of the hospital days sooner this time than last and I was a lot sicker going in this time. So at least recovery time and total time in surgery has decreased.
Good Luck.
Gail
 

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