Prosthetic Aortic Valve Database?

[Bill B]

Hi:

I'm trying to make an informed choice of which prosthetic aortic valve to have implanted next month. The first issue is just getting a list of all the valves available. Has anyone compiled or have a link to a database of available valves, both mechanical and bio? I thought it would be handy to have a database with some basic information about the valves. I've been visiting the websites for SJM, Edwards, On-x, Medtronics and ATS but haven't compiled the information yet.

If not, I guess I'll start now.

Also, are there any bio valved grafts? I'm getting a bunch of Dacron aorta and the surgeon's staff just told me that means a valved graft. However, the surgeon had said earlier I could have a bio valve if I wanted one. Perhaps then they would use a separate graft, but I can certainly see the advantage of using a valved graft in terms of surgical time.

 

[ALCapshaw2]

Here is a copy of a post I wrote outlining Performance Data for the most common Mechanical Valves.

I don't have a lot of data on Tissue Valves other than to note that Bovine Pericardial Tissue Valves seem to have the longest Proven Durability. SOME tissue valves have been known to fail in a very short time (5 years or less), especially Porcine Valves. The New and Improved Tissue Valves *hope* to reach 20+ years. Come back then to see how it worked out. (YES, that is a sarcastic statement)

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A few years ago, On-X sent me an 'Information Package' which included a pair of tables entitled "Morbid Event Rates Comparison" for both the Aortic and Mitral positions with footnotes indicating the source of the data for each company which included PMA (something about Safety and Effectiveness) Summaries (ATS and CMI) and FDA submissions.

The combined rates in (% per pt-year) for Thromboembolism, Thrombosis, and Hemorrhage for the

Aortic Position were

On-X = 2.14 % per pt-year
SJM = 3.90 St. Jude Medical
CMI = 2.96 Carbomedics
ATS = 4.04 ATS
MH = 2.50 Medtronic Hall (I believe that is a single leaflet valve)

Mitral Position

On-X = 1.86 % per pt-year
SJM = 3.34
CMI = 4.44
ATS = 5.07
MH = 4.30

I left off the breakdowns by categories because I'm not about to sit here and re-type all that data. Note that other factors such as Hemolysis (blood cell damage) and Pannus Tissue Growth are not included in the above statistics.

The complete charts are available to ANYONE who asks for them. Just call or e-mail On-X and they will send you whatever information you request. Contact information is on their website www.onxvalves.com or 888-339-8000.

They have recently published another set of Bar Graphs which also include several tissue valves (which I find a little hard to interpret - too much information in too little space... give me the numbers in a spread sheet format please).

'AL Capshaw'

FWIW, Bob H (a.k.a. TobagoTwo) also reported similar numbers from his reasearch.

One other Mechanical Valve Manufacturer is SORIN in Italy. They are affiliated with Carbomedics.

Speaking of Carbomedics, do a SEARCH for "Bokros".
Jack Bokros, Ph.D., and his group are the inventors of Pyrolytic Carbon which is the material used in all BiLeaflet Mechanical Valves. He consulted with St. Jude for their first entry into that market. He Created Carbomedics to supply Carbon materials to the Medical Community. He holds patents on Carbomedics and ATS Valves and he formed On-X to produce his Latest and Greatest design after 20+ years 'in the biz'.

Member "dtread" posted a List of All artificial Heart Valve Manufacturers and their Websites. I don't remember when or where but if you do a SEARCH (any date) with his screen name, you should be able to find it.

 

[Lynlw]

The New and Improved Tissue Valves *hope* to reach 20+ years. Come back then to see how it worked out. (YES, that is a sarcastic statement

Since the newer CE valves have been in use over 20 years now, and 80-90% were still going strong in the patients over 60, and the SJM Biocor has a simular tract record of real data over 20 years, your sarcasm really doesn't make sense.


BillB, There isn't any 1 data source that has about all the valves, and since your were a medical sales I'm sure you know to be careful with info from the company sites, Alot of the data I see is cherry picked studies or outdated "facts" to make THEIR product look the best. With that said I DO believe the ON-X would be my choice IF I or my son needed a Mech valve at this time.

There ARE all in one tissue valves/grafts, but sewing on the graft/conduit really shouldn't be an issue for an experienced surgeon, especially one that specializes in Congenital Heart defects, like Miller and basically rebuilds/reroutes tiny hearts the size of a walnut. My son's heart is quite different and it was his pulm valve/artery that needed replaced, but because of his unique issues, his surgeon basically build in the OR his with 1st a section of conduit then the CE bovine valve and then another section of conduit, OR/bypass time or suture lines really were not a concern.

One of the all in ones off the top of my head is the Medtronic Freestyle, there also is a The Contegra conduit that is a Cows jugular vein, but that is just for the Pulmonary position.

 

[tobagotwo]

The best known tissue valves that include sections of aorta are the Medtronic Freestyle and Hancock, both delineated on the Medtronic website. http://www.medtronic.com/cardsurgery/products/free_index.html I wouldn't rate them as superior to their mechanical conterparts unless the patient has other issues that contraindicate ACT.

On the mechanical valves mentioned by Al Capshaw, one of the issues that Al usually mentions is the pannus protection that is built into the On-X valve. Pannus (scar tissue) growth is one of the three top reasons (along with IE and blood clots) for replacing mechanical valves, which otherwise would generally operate successfully in place for a human lifetime (or two). As pannus can be a liability, it may be something that you may choose to considere in valve choice.

I know that we wrote earlier about marketing departments and opinions on the straightforwardness of their information. However (and you are doubtless already aware of this from having been in the business), it's important not to confuse apparent, unfortunate marketing practices with the value of the actual product. Those remarks made about marketing are not intended to imply that either the SJM or On-X product itself is less than outstanding in its niche or performance, or to give you doubts about either. They have differences that are useful to discuss, but each is demonstrably a premium device in its own right.

I do have some curiosity over the statement that the extra suture line for adding a sleeve on the spot creates a clot issue. You may be aware that in normal circumstances, whenever a graft is used, there is always some form of ACT for the first six months (for "just" a valve, it's only three months). During that time, there is greater danger of clots and IE. However, the dacron velour graft sleeves, any suture lines - all of it - gets coated with endothelium within six months. Then the blood is only touching the body's own, internal skin, with no significantly higher incidence of clot formation or infective endocarditis than any other portion of the body's pipeworks, to my knowledge.

Is it possible that the clot difference figures the assistant brought up for the suture line are actually for the known, six-month endothelial growth period, rather than being numbers that extend into the lifetime of the product after the body has sealed it in? This would make more sense to me, as I've not seen any references to this added risk before, and the use of in situ graft attachment has been around long enough to have raised some alarms by now, were it a continuing risk for the recipients.

In either case, there is ACT for a six-month period as a matter of course, and with a mechanical valve in place there is continuing ACT anyway, which should largely negate that statistic in practice.

Best wishes,

 

[Bill B]

Lots of good information and points made!

If I put together a database, I would restrict it to basic information or keep claims very separate. Obviously, claimed advantages and disadvantages are huge factors in the selection process. You guys spend pages and pages discussing them, and there is considerable doubt about some claims, less about others. So, I'd have to think about how to handle that, if at all.

Bob, thanks for the mention that Medtronics has a bio/graft combo. I missed that in my first visit to look at the Matrix and Freestyle. I will get more info on the suture line thing regarding thrombosis.

 

[ALCapshaw2]

Since the newer CE valves have been in use over 20 years now, and 80-90% were still going strong in the patients over 60, and the SJM Biocor has a simular tract record of real data over 20 years, your sarcasm really doesn't make sense.

HUH?

I know that the ORIGINAL (untreated) CE valves have been in service for over 20 years.

Tell me how "the newer CE valves have been in use over 20 years now". That appears to be a contradiction to my mind.

Please clarify your statement, i.e. how long has CE been putting the 'anti-calcification' treatment on their Bovine Pericardial Tissue Valves?
(I'm pretty sure it's not 20 years. Correct me if I am wrong.)

From what I gather, the goal for the "New and Improved" Procine Tissue Valves (with anti-calcification coatings) is over 20 years. I am pretty sure that those valves have a ways to go before we know their durability potential.

Again, from my understanding, one of the main attractions of the Porcine Valves is a Low Gradient which has great appeal to athletic types who want to maximize their performance.

'AL Capshaw'

 

[BAVD John]

In either case, there is ACT for a six-month period as a matter of course, and with a mechanical valve in place there is continuing ACT anyway, which should largely negate that statistic in practice.

I had my bovine valve implanted just less than two months ago. I left the hospital with 3 prescriptions in my hand, one for Asprin, Metoprolol, and Norco a pain reliever. I asked my surgeon if Coumadin would be necessary for a short time after surgery and he said "no".

I spoke with a church member today that just had a St. Jude tissue valve implanted 3 weeks ago. He will be on Coumadin for a month due to a bout with a-fib in the hospital. So ACT treatment as a matter of course might depend on the presence of a-fib in the eyes of some doctors. I will admit I was a bit surprised that I was not put on Coumadin for a short period of time to control the possibiliy of a-fib.

 

[Lynlw]

HUH?

I know that the ORIGINAL (untreated) CE valves have been in service for over 20 years.

Tell me how "the newer CE valves have been in use over 20 years now". That appears to be a contradiction to my mind.

Please clarify your statement, i.e. how long has CE been putting the 'anti-calcification' treatment on their Bovine Pericardial Tissue Valves?
(I'm pretty sure it's not 20 years. Correct me if I am wrong.)

From what I gather, the goal for the "New and Improved" Procine Tissue Valves (with anti-calcification coatings) is over 20 years. I am pretty sure that those valves have a ways to go before we know their durability potential.

Again, from my understanding, one of the main attractions of the Porcine Valves is a Low Gradient which has great appeal to athletic types who want to maximize their performance.

'AL Capshaw'

I was talking about the CE Perimount
http://jtcs.ctsnetjournals.org/cgi/reprint/131/3/558.pdf
This study is from 2005
Under Patients and Methods it states
"Patients
Pericardial prostheses. Clinical investigation of the Carpentier-
Edwards stented bovine pericardial bioprosthesis (PERIMOUNT;
Edwards Lifesciences LLC, Irvine, Calif) began in 1981. Between
September 1981 and January 1984, 267 patients with isolated
aortic valve disease (with or without ischemic heart disease) had
this prosthesis implanted at 1 of 4 centers as part of the premarketing
clinical investigation for the US Food and Drug Administration.
Results of its durability to 17 years after implantation have
been reported,8"

On page 5 it describes the valve
"The Carpentier-Edwards pericardial prosthesis is a secondgeneration
stented bovine valve that is low-pressure fixed in
glutaraldehyde and treated with the anticalcification agent
polysorbate (Tween) 80. The majority of these valves have
been used in older patients, in whom they have been quite
durable. For patients age 65 or older, the chance of reoperation
is less than 10%.8 The excellent hemodynamic profile
and ease of inserting the prostheses led to liberalizing
their use in younger patients during the premarket phase of their introduction."

 

[tobagotwo]

It has been standard treatment for many years to have warfarin prescribed after a new tissue valve implantation for about 90 days. Many of our members had that and can vouch for that, and it's still being mentioned by some new valve recipients.

I had only Plavix prescribed for the valve put in five years ago instead of Coumadin, and it was considered radical at the time. When I was let off it after about a month, some folks here thought it was a bit reckless.

This time I have Plavix again, but I also have on-and-off AFib, so the reasoning for having it is muddied. ACT (mostly Coumadin, Plavix, and/or aspirin) will not control the occurrence of AFib, by the way: it's used to reduce the likelihood of clots from the flow interruptions within structures of the heart caused by AFib. Metoprolol, dronedarone, and amiodarone are more common for trying to relieve AFib chemically.

Aspirin is also a form of ACT, accomplished by making the platelets more "slippery," so they won't stick together. Its use is fairly ubiquitous now, as most people tolerate it exceptionally well, and it's been shown to reduce the number of strokes in the general population over 50 (? 55?).

My surgeon had mentioned something about some surgeons (including himself) no longer using any form of ACT routinely past a few weeks for aortic valves, although mitral valves were still being treated with more aggressive ACT. However, I don't know how common that has become within the surgical community. He tends to be ahead of the curve. Certainly, it's reached where you had your work done, as your only form of ACT is aspirin, John. I consider that a plus for your surgical and aftercare team.

Best wishes,

 

[Lynlw]

Justin wasn't on anything after either of his Bovine valves/conduits. I actually called and asked his other card at a different hospital if that was his recomendation too and he said yes.
I think there were a couple discussions about this, from time to time, for some reason I remember Mary saying she wasn't on any

 

[BAVD John]

Bob,

Yep, based on my research I thought it was standard procedure to prescribe Coumadin for a short period of time after surgery. I actually asked McCarthy twice if I would be on Coumadin after surgery. I was a bit surprised by his "no" response.

ACT (mostly Coumadin, Plavix, and/or aspirin) will not control the occurrence of AFib, by the way: it's used to reduce the likelihood of clots from the flow interruptions within structures of the heart caused by AFib.

Yep again, that Coumadin is used to reduce the likelihood of clots. I knew that and apologize for my mistake above.

McCarthy is the Chief Cardiac Surgeon at Northwestern and believe he is one of those surgeons that is ahead of the curve in cardiac surgery.

I apologize to Bill as I did not intend to change the focus of his thread.

 

[dtread]

U.S. Heart Valve Manufacturers:

ATS – Mechanical & Biological Valves (equine). Headquarters: Minneapolis, MN www.atsmedical.com

CryoLife, Inc. – Allografts. Headquarters: Atlanta, GA www.cryolife.com

Edwards Lifesciences - Biological Valves (porcine and bovine). Headquarters: Irvine, CA www.edwards.com

Medtronics - Mechanical & Biological Valves (porcine). Headquarters: Minneapolis, MN www.medtronic.com

On-X Life Technologies, Inc. - Mechanical Valves. Headquarters: Austin, TX www.onxlti.com

Sorin Group (Carbomedics) - Mechanical and Biological Valves (bovine). Headquarters: Austin, TX www.sorin-hv.com

St. Jude - Mechanical and Biological Valves (porcine and bovine), also Alllografts. Headquarters: Minneapolis, MN www.sjm.com

Note: Biological is simply another name for “Tissue”, and Biological Valves are either Bovine (cow), Porcine (pig), or Equine (horse). There are also valves called “Homografts” or “Allografts” that are from cadavers.
Note: Mechanical heart valves today are all the “Bileaflet” design except for the Medtronic mechanical valve, which is the “Tilting Disc” design. In the past there was also the “Ball and Cage” design, but this design is no longer sold in the U.S.
Note: Some of the above also sell products for valve repair (versus valve replacement)

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Outside of U.S. Heart Valve Manufacturers (not approved for use in U.S):

Sorin Biomedica Cardio - Mechanical & Biological Valves. Headquarters: Italy http://www.sorinbiomedica.com/

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In-Home Anticoagulation Testers:

Coaguchek (Roche Diagnostics) Headquaters: Indianapolis, IN www.coaguchek.com

INRatio (Hemosense) Headquarters: San Jose, CA www.hemosense.com

Protime ITC Subsidiary of Thoratec Corp., Edison, NJ
www.protimesystem.com www.itcmed.com

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Anticoagulation Services:

QAS (Quality Assured Services, Inc) Headquarters: Orlando, FL www.qualityassuredservices.com
Raytel Cardiac Services Headquarters: Windsor, CT www.raytel.com
Tapestry Medical Headquarters: Livermore, CA www.tapestrymedical.com

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Please advise if any of the above is incorrect

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http://www.youtube.com/watch?v=Gbfnh1oVTk0

 

[Jkm7]

I had CE bovine mitral valve placed about 1 1/2 years ago and was ordered 3 months ACT. In the end, my surgeon stopped it at 2 1/2 months.

I think it may differ by which valve you have replaced. Surgeons seem to order it more often for mitral because of the difference in blood flow.

 

[tobagotwo]

Had some difficulty locating the Hancock conduit info, but here are downloads for brochures for the Hancock with valved conduit and the Freestyle, should they be helpful to you:

http://www.medtronic.com/wcm/groups/mdtcom_sg/@mdt/@cardsurg/documents/documents/hancock-valves.pdf

http://www.medtronic.com/wcm/groups...documents/documents/freestyle-heart-valve.pdf

Unfortunately, these are patient brochures, so there is some lead-in that you have to wade through before you get to the meat.

Best wishes,

 

[Johan]

My surgeon had mentioned something about some surgeons (including himself) no longer using any form of ACT routinely past a few weeks for aortic valves, although mitral valves were still being treated with more aggressive ACT. However, I don't know how common that has become within the surgical community. He tends to be ahead of the curve. Certainly, it's reached where you had your work done, as your only form of ACT is aspirin, John. I consider that a plus for your surgical and aftercare team.

I had my AVR tissue valve on 1 July and my surgeon sent me home on a beta blocker and aspirin. Lighter ACT seems to be the norm nowadays. Johan

 

[JeffM]

Again, from my understanding, one of the main attractions of the Porcine Valves is a Low Gradient which has great appeal to athletic types who want to maximize their performance.

'AL Capshaw'

That was a huge factor for me. Also, because I had a BAV and migraines, I was concerned about the possibility of being at higher risk of a brain aneurysm so preferred to avoid long term ACT. I'm at one year and so far all is well regarding athletic performance. If I get 20 years out of the valve, I'll be pleased. I don't want to undergo another OHS with full sternotomy in my mid 70s but if I can keep up with the athletics until then, maybe I'll be out in 3 days again if that's the only choice I have at that time. But there's risk with every decision.

 

[Gail in Ca]

My surgeon said to count on only 10 yrs with a tissue valve, and that was just this past Feb. I wasn't sure what kind I would get, he made the decision when he got inside and looked at the damage from the BE. I still wonder why a well known, great surgeon says 10 yrs, when so many are told they last much longer. I would suggest to do your homework on the tissue valve longevity. I got another mechanical, St judes with conduit this time replacing carbomedic.

 

[Bill B]

My surgeon said to count on only 10 yrs with a tissue valve, and that was just this past Feb. I wasn't sure what kind I would get, he made the decision when he got inside and looked at the damage from the BE. I still wonder why a well known, great surgeon says 10 yrs, when so many are told they last much longer. I would suggest to do your homework on the tissue valve longevity. I got another mechanical, St judes with conduit this time replacing carbomedic.

Gail: My surgeon, clearly one of the best and the immediate past-president of the American Association for Thoracic Surgery, says the same thing. I haven't questioned him specifically about the Edwards valve or the St Jude's Biocor and the data the companies have about re-operation, but he made a direct comment that although the 3rd generation valves are "better" they are still in the range of 10-15 year re-operation. At least that is what I thought I heard. It was crystal clear he thought I was too young (62) for a biologic valve. I know he favors the same valve/graft combo you got.

Wait a minute - you and I probably have the same surgeon!

 

[Lynlw]

Gail: My surgeon, clearly one of the best and the immediate past-president of the American Association for Thoracic Surgery, says the same thing. I haven't questioned him specifically about the Edwards valve or the St Jude's Biocor and the data the companies have about re-operation, but he made a direct comment that although the 3rd generation valves are "better" they are still in the range of 10-15 year re-operation. At least that is what I thought I heard. It was crystal clear he thought I was too young (62) for a biologic valve. I know he favors the same valve/graft combo you got.

Wait a minute - you and I probably have the same surgeon!

You do have the same surgeon. Also I believe that was Gails 3rd OHS

 

[Bill B]

You do have the same surgeon. Also I believe that was Gails 3rd OHS

Egads! I just read some of her previous posts. What a trooper Gail is! She seems to have had a great recovery from this last OHS. I hope I do even half as well after mine coming up next month.