Mechanical or tissue aortic valve?

[Jurassic Cowboy]

I am a 61 year-old male (nearly 62) with an aortic valve that will have to be replaced pretty soon, so I am facing the classic choice of a mechanical valve and coumadin or a possibly shorter-lived tissue valve. I do not have an independent need for anticoagulation at present. I do have a few other ?bleeding issues? that might be relevant. I have a chronic case of basal cell skin cancer that requires surgical excision or treatment of the sites with a cream that causes some bleeding towards the end of the treatment about every 6 months. Also, I have an enlarged (but so far not malignant) prostate that probably will have to be removed sometime. Finally, I have a family history of colon cancer, although no tumors have showed up in me as yet. Professionally, I am a marine geologist (hence the nickname above). When I go to sea I work in remote areas, generally for about a month on ships without doctors. Sometimes we are a week out from any port, and medical facilities in such ports are often, well, limited.

For all of the above reasons am currently leaning towards a tissue valve, as I see that the Cleveland Clinic is now, in general, recommending tissue valves for patients over 60 and for many males over 50. About 85% of their AVRs in 2003 were tissue valves. I have been impressed by the extended durability of the Perimount Carpentier-Edwards (CE) bovine pericardial valve as reported in the recent literature (2001-2004) relative to porcine aortic valves. I see on this website that several of you have had the new CE Perimount Magna valve implanted, which may be even better. However, I also understand that a mechanical valve probably will outlast even the newest tissue valves and that I might need a redo on a tissue valve in 10-15 years.

My main question is, if you were I, knowing what you know now (and that?s a lot more than I know now) what would you do? More specifically, is coumadin really that big a hassle? Could I work blood tests around a ship schedule such as I describe above? Does the CE Magna valve now have full FDA approval, so that anyone can get one, or are they still in the testing stage? Many thanks for any answers you might have and for your time and effort on my behalf.

 

[catwoman]

Cowboy:

My father-in-law had his first MVR @ 68-69 (porcine) and again 10 years later, also porcine (along with quad CABG, at least one, maybe 2 other valves also replaced).
That tipped the scales for me, so I got a mechanical a year ago when my valve went south. I'm 54 now.
BTW, a friend's mother near Albuquerque NM had VR surgery 12 years ago -- at age 72. She got a St. Jude valve; she didn't want to go through surgery again.

I have not had problems with Coumadin (will go through a colonoscopy next month, my first post-op); I have my own protime machine and now adjust my Coumadin dosage myself, thanks to information available from Al Lodwick at the Coumadin forum elsewhere here. I eat pretty much what I want, don't exclude vitamin K foods just because they have vitamin K.
I travel almost every weekend showing and judging cats, which holds some risks in itself because cat bites can be extremely serious, even life-threatening, injuries.
I have not noticed any appreciable increase in bleeding, other than a few bruises. But then, I've always been a little clumsy.

Mechanicals aren't for everyone, and tissues aren't for everyone. You have to base your decision on what you feel is best for you. Good luck with your research.
This is a great place to come for support, both pre-op and post-op.

 

[ShezaGirlie]

Welcome Cowboy...

Welcome Cowboy...

First, welcome to VR.COM and the many caring folks who frequent this website.

You asked:

My main question is, if you were I, knowing what you know now (and that?s a lot more than I know now) what would you do? More specifically, is coumadin really that big a hassle?

Easy answer for me....I'd go to the Cleveland Clinic and have the Perimount Carpentier-Edwards (CE) bovine pericardial valve installed in a New York minute!

In October of 1999 at age 55, I got a St. Jude mechanical and the lifelong prescription for Coumadin. I'm no fan of Coumadin. It interfers with any future medical tests in a BIG way. I gave up travelling to third world countries and travel is my passion. I consider it a ball and chain -- a lifelong sentence, if you will. Every time a medical issue comes up such as those you evidentally are facing, anticoagulation will be a big deal. Since I was an emergency case, I didn't have the choice as the St. Jude valve was the only one offered to me -- remember this was five years ago.

It says a lot when the premier heartcenter of the world - Cleveland Clinic - installs mainly tissue valves....85% tissue vs. 15% mechanical.

Best of luck with your decision... PM or email me through this site and I'll really let you know how I feel...

 

[Marty]

Welcome to VR.com JC! Six years ago my surgeon installed a mechanical St.Jude. I asked why not tissue ? when I woke up in the recovery room and he came in. I was 72 at the time.He said it was a close call but I was in pretty good shape and it looked like I might last a while and he didn't think reoperation in my 80's would be good.I said I heard tissue valves last 10, 15 years even longer but he said he has had them come back sooner also.So far its been OK for me. As Janie says ,Coumadin has problems but in my case ,I no longer am exposed to sports trauma( unless I get hit by a golf ball) and luckily have not needed any surgery or been in a MVA. However I would definitely advise you to go tissue. They have made a lot of progress and those new CE bovine pericardials are looking better and better.. Best wishes, Marty

 

[Ross]

I used to be for mechanical all the way, but with the more time goes by, tissue valves are improving. I would say take that tissue valve. Of course, once inside, you may or may not have the equipment to accommodate one and may have to go mechanical, but I think if I were you, tissue first choice, mechanical second.

 

[Bryan B]

Given your circumstances I would lean towards the tissue as well. Just remember that you may outlive it and need another one down the road. But if you get 20 years out of it without the worry of anti-coagulation I guess you could look at that as a positive.

Good luck, and remember that either decision is a life saving one...therefore a good one!

 

[Phyllis]

Dick, who turned 71 this year, and is very active, tennis, golf, boating had the Edwards Magna Valve last December at Brigham and Women's in Boston. It is fully approved, but not sure if all hospitals have it - Cleveland and Brigham for sure. If you put in a search for Edwards bovine Magna valve, you will see some posts here and also can read about it on the Edwards website. Our vote is for the bovine valve, magna or regular. They are using the Magna valve for people who are very active as it provides better blood flow. Dick insisted on it, but the doctor said that he could have done with a regular Edwards bovine valve as his annulus opening was very large.

 

[Johnny Stephens]

Hello there Cowboy. [insert standard discaimer, I'm not a doctor, etc.]

From what I read about your lifestyle, it seems to me that the tissue valve would be a better fit for you.

Coumadin hasn't been that big of an issue for me, but then I'm lucky in several areas:

• My Anticoagulation specialist has a clue about managing and adjusting dosage
• I live in a metropolitan area, within a couple of miles of my clinic
• I travel, but it's to other big cities (not stuck out on a ship for weeks on end)

I wound up with 2 mechanicals because I was in my early 40s and had a medical history with radiation treatments that made my first surgery "very technically challenging." Scar tissue, adhesions, pulmonary hypertension, all played a factor in wanting to make this my only surgery.

Good luck with your decision.

 

[Jims]

Hi Cowboy,

I am in a very similar boat as you. I am 57 and very active. I have a bicuspid aortic valve and it needs to be replaced.

I am scheduled for surgery for AVR on Sept. 15th 2004. NEXT WED.! So your post and all the answers is very relevant to me too! Thanks for the post. Even though these questions have been asked many times in the past, things change and it sometimes pays to re-ask the question.

I have a meeting with my surgeon today to discuss the valve options. I will discuss the Edwards Magna with him today. I'll let you know what he says.

Jim

 

[Jurassic Cowboy]

First, thanks to all of you who replied so quickly with information and advice. I greatly appreciate all of it. Especially useful was the note from Phyllis and Dick, saying that the Magna tissue valve is available at Brigham and Women's in Boston. I live in southern Rhode Island and would like to be within fairly easy driving distance of where the hospital where the surgery is done, and B & W is certainly that for me. Also to Jim, I'll be very interested in what your surgeon says about the Magna valve. It sounds good in the promotional literature from CE, but is only recently released so there's not much track record on it yet.

I do sense from various places that even if you decide on a tissue valve before surgery, it may not be possible for physical reasons the surgeon discovers when he/she opens you up and can actually see what has to be dealth with. I gather that if insertion of a tissue valve is not possible or recommended for some physical reason, then a mechanical valve is the fall back option. To anyone who knows, is this essentially correct and what things might the surgeon encounter that would suggest a mechanical valve would be a better solution?

Again, thanks to everyone for the info,
J. Cowboy

 

[Granbonny]

Hi J Cowboy

Hi J Cowboy

I was age 61..very active..but they found an aneurysm in me on a Thursday and I had surgery on Monday. The surgeon told my family on Thursday..that I will put a mech. valve in her..due to her age...and I don't want her to have to have a re-op in the future....Didn't have much time to thimk about it..but glad I have a mech. valve. That would have been..that I would have had to have a re-op around age 75..Which, is still young.. Coumadin has never been a problem with me..Had teeth extracted, ect......I have heard several times today on T.V. that President Clinton will be normal in 3 months.. It took me a full year to feel normal again..First 3 months..Just no energy. Lucky, I have a wonderful Hubby (married 38 years ) retired and he took over the cooking, ect... I give credit to my rebounding to helping raise a very active age 12 year old Grandson.. I hang with him now with all his activities.. ...My concern if you have to have a mech valve would be..Could you get your coumadin supply..to last you..out in the middle of nowhere?..I have a home tester..available from QAS..our VR sponsor.........You need to sit down with your surgeon BEFORE your operation..and ask him what the options would be..if you cannot get a tissue valve. Good Luck..Bonnie

 

[Granbonny]

Jim

Jim

Please post what your surgeon had to say, today...and we will be wishing you the best of luck, next Wed. Bonnie

 

[Phyllis]

Since you live in RI (we live in CT), I strongly suggest that you get in touch with Dr. Lawrence Cohn at Brigham in Boston. He did Dick's surgery and more recently Randy's surgery and both were minimally invasive (4" cut of the sternum instead of the whole sternum). He is one of the "best". If you have a high speed connection you can watch a video of him performing the operation at http://www.or-live.com/BrighamandWomens/1127/. Any questions we would be happy to answer by private message or private email. I'm sure Randy would be happy to tell you of his experience too. He traveled from Pensacola, FL to have Dr. Cohn operate and was very pleased with the outcome.

 

[Dirk]

Well, I am also in the decision phase what valve to take.

I came to the following conclusions:

1. A mechanical valve ist not a bad thing, because no second surgery is necessary. Coumadin is not a problem at all. This has been proven in a lot of studies. However, it is mandatory that you make your own home testing of the INR. If you have such a device (the leading brand is Coagucheck from Roche) you can travel overall the world without any problems!
Possible issues of the mechanical valve are the sound you may hear and the problems of HITS or MES, which are microembolies each mechanical valve produces and shoots into your brain. They cannot be influenced by Coumadin.



2. Considering a tissue valve it is not clear for me so far, which are the superior ones. I just learnt, that the Edwards Magna is approved, but I cannot find any approval information on the FDA website.

I am also wondering what would be the best solution:

The Carpentier Edwards Magna or the Medronic Mosaic.

Does anybody has an opinion on that?

Greetings


Dirk

 

[Mary]

Dirk,
I just wanted to mention that one can't state categorically that after replacing with a mechanical valve, that no more replacements will be necessary.
Although the stastics are very good, we have had a few members of the forum who have had to go back for another replacement after the initial mechanical valve was put in place.
Mary

 

[Phyllis]

Here's the FDA approval from their site:
P860057/S022

"1/26/04

180-Day
Carpentier-Edwards® Perimount® Pericardial Bioprosthesis, Models 2700, 2800 (Perimount® RSR), 6900P (Perimount Plus®), and 3000 (Perimount Magna®)
Edwards Lifesciences LLC

Irvine, CA

92614
Approval for the addition of a post-fixation tissue heat treatment step solution prior to the Edwards XenoLogiX® tissue valve processing steps. The devices, as modified, will be marketed with the reference to ThermaFix? as the trademark/brand name for the tissue processing method and will be identified according to the following modified model numbers: Models 2700 TFX, 2800TFX, 6900TFX, and 3000TFX."

Dick received the Edwards Magna valve last December before the ThermaFix was approved.

 

[Phyllis]

Here's an excellent post by Tobagotwo re: valve selection and a comparison of the Edwards and the Mosiac:


"Of the tissue valves, the two which consistently float to the top are the Medtronic Mosiac porcine valve and the Carpentier-Edwards Perimount bovine valve (by Edwards Lifesciences, Inc.).

The new, CE Perimount Magna is stentless. However, the regular CE Perimount model does have a stent, and is now made with the same processes. It has, as far as documentation can be trusted, the longest life cycle of all the tissue valves, with 90% lasting at least 18 years. It is a manufactured valve, sewn together from natural cow pericardium which has been run through fixation and preservation processes. Its main advantages have been that it takes longer to calcify and the leaflets do not deteriorate as fast as others. The latest model also has a chemical anticalcification process applied to it, and the website is now showing a low-pressure fixation process (possibly similar to Medtronics' process) that was not displayed a month ago.

However, surgeons usually treat the CEPM/CEP valve as their second choice, as it is not completely naturally configured. I suspect that there is also that underlying concern that some manufacturing flaw will be discovered, and their patients might be involved (although there is no reason to assume this would happen). There is similar reluctance with certain of the mechanical valves.

The Medtronics Mosaic is the premier porcine tissue valve. It is a natural pig aortic valve, run through a fixation and preservation process. Its previous numbers put it at three to five years less service life than the CEPM. However, a new process is being used that does not damage the valve leaflets with physical pressure during the fixation. That is expected to extend its life greatly. Also, an anticalcification process (AOA) has been added to decrease degradation of flexibility.

Surgeons tend to like that this is a "real" valve, and operates in an entirely natural manner. The general feeling seems to be that it should work best with the rest of the heart functions, although I doubt that there is literature that would actually validate those intuitions.

The stent that is in the Mosaic is a very flexible stent, and is half the width of the stents of previous models from Medtronics and other companies, which allows more bloodflow diameter for its size. However, I have not seen any documentation that would lead me to believe any stent is a factor in a tissue valve's demise. Some older mechanicals can eventually cause heart tissue problems where they were sewn in, due to the constant, on-off pounding and flow restriction, but that is not generally a tissue issue.

The stent also helps to hold the shape of the root and provides a more stable seam area for the surgeon to sew in. A description I've heard of heart surgeons is that once they're in the chest, they're human sewing machines.

Regarding natural action of the valve, my echo tech showed me a video of my heart beating, and declared that she could not tell any difference between it and a normally functioning original valve, and would not know that it was a replacement if she hadn't known about the surgery. That is the Gold Standard for me.

As far as what I originally wanted: I was torn between the CEPM and the MM, and my surgeon was agreeable to implanting either one. It turns out that he was one of the top surgeons in the world for the most Mosaics implanted. I decided to take that as a gentle hint.

It would be good to understand what underlying value the surgeon feels there would be to the root-configured valve before ruling it out. Any of the valves discussed here should be an excellent choice, depending on what you eventually learn about your exact condition.

Best wishes,
__________________
Bob H

Aortic Stenosis w/severe calcification. Aortic valve replaced by Medtronics Mosaic porcine tissue valve on 4/6/04. The procedure was performed by Dr. Tyrone Krause, Chief of Thoracic Surgery, Robert Wood Johnson University Hospital, New Brunswick, NJ. Dr. Krause is a true Zen Master Mechanic in the world of valve replacement surgery. "

 

[Jims]

Surgeon Meeting

Surgeon Meeting

I met with my surgeon yesterday. I asked the surgeon if I could tape record our discussion, because I often walk out of there and sometimes remember only a small % of what was said. He allowed it. I am really glad I did!

The surgeon said that he would install any valve I wanted. He knew from our previous meeting that I wanted to avoid coumadin. So, he said that he could install an Edwards Perimount. Now, he said that this valve was stinted and Bob above indicated that the Magna was stintless. So I am now not sure if we were talking about the same valve. He said all of the Edwards pericardial valves are very good and will last about the same time as the Magna.

He also said that he was the lead investigator for the "St. Jude EPIC bioprosthetic" valve, and that I could sign up to be included in these these trials. The hope with this valve is that it will last even longer than the pericardial. I am going to start another thread on this valve, though I don't have much time to get replies. There seems to be so much to do now that I realize I am going to be down for at least 4-6 weeks.

The way this seems to work is, if you have no idea which valve you want, the doctor will choose for you, based on age and other factors. If you know what you want the doctor will install that valve.

I asked the doctor, what would change his mind after we agreed upon a plan for the valve. He said the only he would change would be if he got in there and found that the aortic root was very small, then he would choose a homograph.

I asked why would't he choose the homograph first, and he said it is a much bigger operation and that they don't last forever either, and that they are much more difficult to remove when they do wear out, than the pericardials.

So, right now, I am thinking pericardial tissue or participate in the St. Jude Clinical trial with the EPIC.

Jim

 

[Dirk]

Dick an Pyhllis:

You are right.

But what I did not find was a copy of the full approval document.

For all other valves, there is the "Summary of Safety and Effectiveness Data" paper part of the approval and can be found on the website ofthe FDA (for examples for the Medronic Hancock II or the Mosaic valve.

I am wondering why these data are not yet published for the CE Magna.

Greetings


Dirk

 

[Phyllis]

Dirk,
I'm afraid I don't know the answer to your question. There is a number posted for the summary, but it is not a clickable link. I do know that the Magna valve was used in Europe and Canada for many years before it was approved here. Dick wanted the newest technology and I had a niggling feeling that going with the tried and tested was the best way to go, but here's hoping that he chose the right valve. The fact that both Brigham and Cleveland are using it gives me faith.