What's The Best Mech Valve

[jkn2kids]

I'm trying to get some kind of opinions from everyone regarding mechanical valves.I'm going to be having one put in and want to get the best possible valve.Is the St.Jude the best? Also,are there any websites that you can visit to get an idea about the types of valves?

[twinmaker]

I have a St. Jude mechanical mitral valve and it was put in in August 1981. This thing is over 24 years old, and it just keeps clicking and clicking and clicking. Linda

[Rich]

I've had my St. Jude mechanical aortic valve since July of '96 and it's been great.

Rich

[Karlynn]

St. Jude mitral - 14 years. St. Jude has been thought of as the Gold Standard for some time now. However, the On-X valve has been gaining in popularity lately because of aspirin studies.

[ALCapshaw2]

For Longevity, nothing comes close to the St. Jude (standard) Mechanical Valve. It's been around for a LONG time and has been laboratory tested for more cycles than any of us are likely to see.

The new (third generation) mechanical valves (On-X, ATS, St. Jude Regent, Sorin, etc) have been designed taking fluid dynamics into consideration to reduce turbulence with a lower liklihood of producing clots.

There has been LOTS of interesting discussion on these new valves which you can find by clicking on the SEARCH tab at the top of this page and typing in the appropriate valve name as the keyword.

You can also find websites for the different valves by doing a normal (Google, etc) internet search or from links in the above cited discussions.

That should keep you busy reading for some time!

'AL Capshaw'

[RCB]

I'm trying to get some kind of opinions from everyone regarding mechanical valves.I'm going to be having one put in and want to get the best possible valve.Is the St.Jude the best? Also,are there any websites that you can visit to get an idea about the types of valves?

.......what you mean by best- Many heart surgeons disagree!

[Ross]

.......what you mean by best- Many heart surgeons disagree!
I thought sure you'd of come off with "The one that keeps you alive"! :D

[Curtsmum]

I thought sure you'd of come off with "The one that keeps you alive"! :D
I'll go with that one, i would be happy to go along with whatever the surgeon choses, do you have to choose? or can you just be told. I dont think i could handle making a choice:confused: ?

[Marty]

I'm trying to get some kind of opinions from everyone regarding mechanical valves.I'm going to be having one put in and want to get the best possible valve.Is the St.Jude the best? Also,are there any websites that you can visit to get an idea about the types of valves?

At Inova Fairfax they use only St. Jude. Mine is still fine after 7 years. The newer valves like the Regent are supposed to be even better.

[Ross]

I'll go with that one, i would be happy to go along with whatever the surgeon choses, do you have to choose? or can you just be told. I dont think i could handle making a choice:confused: ?
You can ask for a specific, but if the surgeon has never used it, you might be out of luck unless you find one that has used it. St.Jude is the gold standard, but if you could, you might want to look into On-X.

[geebee]

I am a very conservative person so I generally lean towards the long-term proven valves. I have a St. Jude mitral that has been in for 11 1/2 years and doing very well. Much happier with it than my old Bjork-Shiley.

[terryj]

My husband has the ATS Mechanical aortic valve. That is what his surgeon at Emory uses. They have a website. use search for ATS Mechanical Aortic Valve. His INR is set at 2.0 to 3.0 with this valve. We are more comfortable with 2.2 to 3.5 so that is what we shoot for.

[Gemma]

I'll go with that one, i would be happy to go along with whatever the surgeon choses, do you have to choose? or can you just be told. I dont think i could handle making a choice:confused: ?

When we asked Jim's surgeon's registrar, he said Jim would probably get a St Jude. Then the surgeon came in and said no, he'd be getting a Sorin valve - better performance than the St Jude. Jim's an engineer and all the talk of improved pressure gradients etc swung it for him. They're not used in the USA to my knowledge, but Paula, you may find Curtis' surgeon mentions it, or the On-X which Emma's daughter Chloe has. Probably has to do with the preference of whichever NHS trust, hospital or surgeon decides on valves in your area of the UK I'd think. Of course, if you do get offered a choice often the best thing to ask the surgeon is "which would you choose for yourself/your child?"

[Natanni]

My husband had his aortic valve replaced in 9/2005 with a Carbomedics 29 mm and today was the first day I checked out the Carbomedics website. The Carbomedics are apparently made by the Sorin Company, and I do remember one of the other members telling me that the standard mechanical valves of Carbomedics and the International Sorin were similar--can someone clarify?

[GaryReece]

I have a ST Judes 25mm Aortic Valve. Its true the St Judes is the Gold Standard and the only one my surgeon will install. I have had it for 14 months and had no problems.

[Gemma]

My husband had his aortic valve replaced in 9/2005 with a Carbomedics 29 mm and today was the first day I checked out the Carbomedics website. The Carbomedics are apparently made by the Sorin Company, and I do remember one of the other members telling me that the standard mechanical valves of Carbomedics and the International Sorin were similar--can someone clarify?

Carbomedics and Sorin are both owned by the Sorin Group. They make their own valve ranges though. If you check out www.sorin-cid.com and follow the links to the Bicarbon range of valves you'll be able to compare them to the Carbomedics ones. I know one obvious difference is the curved leaflets on the Sorin valves, not sure if any others have that (from the quick glance I just had at the Carbomedics site, I don't think carbomedics valves do).

Haven't looked into the performance of Carbomedics valves, but I'd guess it's comparable to the other third generation valves as mentioned by Al previously.

[Sherry]

I've had a St. Jude's mitral since June of 97. I'm eight years and counting.

[afraidofsurgery]

I also have an ATS valve, surgeon's preference over St. Jude for my 9/7/05 aortic valve replacement surgery. I understand the same guy who designed the St. Jude valve also designed the ATS valve but with a few minor tweaks that cause it to be quieter and potentially have a lower risk for blood sticking to its leafelets (but this has not been proven).

The valve is really quiet, and the only downside i ever hear about the St. Jude is its clicking but I have never heard one the St. Jude valve personally.

On the other hand, the St. Jude valve has all the data and published studies behind it that you can hang your hat on. Last one I read was for 25 years of data.

I'm very happy with my ATS valve, and of course just happy to be alive and not leaking anymore :)

Patty

[Marty]

Patty, You and your surgeon may very well have settled on a superior mechanical valve. However my valve expert who has built valves and installed them since early 1970's says one cannot be sure until there are long term high quality studies demonstrating superiority, ie with cath data and a mean follow up of at least six years. That takes thousands of patients and lots of work to do it right. All new valves look good to the commercial interests but not all stand the test of time. So far, none recommend not using warfarin.

[MSG Morrissey]

My St Jude has a "lifetime warranty"!!!
RDRR

[JCDavis81]

My valve (a St. Jude) better be the best -- It's got to keep clicking for the next 60 years! ;)

[tobagotwo]

RCB is right. Surgeons disagree. Interestingly, they have little more information available to them about these valves than we do. And much of what they do hear is directly from the manufacturers' salespeople.

Here are my thoughts...

The only current mechanical valve with a thirty-year track record is the St. Jude Medical Heart valve. The other valves are all more recent. The St. Jude valve's design is almost unchanged since its inception, both reassuring in its constancy and quizzical in its lack of movement.

It's a solid valve choice. The reference to it being The Gold Standard was coined by the manufacturer, but it is undeniably the vehicle that has served more of this site's mechanically-fitted hearts than any other model.

Carbomedics valves were introduced in 1986, and have a good track record of their own. They are owned by the Sorin group, as their US arm. Along with their standard valve, they have a top-hat-style mechanical valve design that allows placement above the annulus, so a larger valve size can be used for greater bloodflow. This placement arrangement is touted by several tissue valve manufacturers as well.

ATS, On-X, and Sorin valves are considered new-generation valves. They use pyrolytic-carbon-based, 100-plus-year materials very similar to the St. Jude valve. They also employ its basic, successful design. They have specifically altered that design to reduce platelet damage and clotting tendency. Areas that were prone to stagnant blood pooling are "washed" by curved areas on the leaflets to reduce clotting potential. Redesigned, soft-strike hinge mechanisms reduce damage to blood platelets (hemolysis) and are claimed to reduce valve clicking noise levels.

Both ATS and On-X are currently challenging the Coumadin requirement, feeling that their valves may be capable of running acceptably stroke-free with aspirin therapy. On-X is currently in trials with aspirin ACT (AntiCoagulation Therapy) outside the US. Those trials have not been completed, so the results will remain in the air for some time. However, they have not had to be stopped yet, either, which is at least not a bad sign.

Here are the manufacturer sites, which is a good place to start.

http://www.atsmedical.com/Content/iropvalve.php

http://www.onxvalves.com/ValveInformation.asp

http://www.sjm.com/devices/device.aspx?name=SJM+Regent%26%23174%3b+Valve&location=us&type=18

http://www.carbomedics.com/professional_products_staortic.asp?from=us

Sorin valves are not available in the US. Their branch here is Carbomedics (above), and they do not offer the exact same line of valves as Sorin of Italy. However, here is the Sorin site for those abroad and for general interest:

http://www.sorin-cid.com/bicarbon.asp

At this juncture, my personal mechanical favorite in the US is the On-X. However, the appearance is that you can't go badly wrong with any of these leading manufacturers.

Best wishes,

[Kathy Canistro]

I have the standard St Judes mechanical valves for Aortic valve replacement and Mitral valves replacements, I wasn't allowed a choice. These were the choices of my surgeon.

Good luck with your surgery
Kathy

[MarkU]

What's the best mech valve? My St. Jude. But you can't have it, I'm not done with it yet...;)

[Baldrick]

Just for the record, my surgeon strongly advised me against the St. Jude (ended up going with a Carbomedics). He was very disenchanted after the whole recall episode.

[Cooker]

Just for the record, my surgeon strongly advised me against the St. Jude (ended up going with a Carbomedics). He was very disenchanted after the whole recall episode.


I am new. What recall are you talking about?

Thanks,
Cooker

[Baldrick]

It had to do with some kind of coating called Silzone. Refer to their own website:

http://www.st-jude-heart-valve.com/pages/ST_jude_heart_valve_recall.html

http://www.st-jude-heart-valve.com/pages/st_jude_valves_recalled.html

Or see also:

http://www.legallawhelp.com/safety_and_health/saint_jude_heart_valve/

[RandyL]

RECALL!

What recall?
When was this, How in the heck do you have recall? I need to hear more about this immediately. I had mde my mind up for the St.Jude valve. I am only 2 weeks away and now you talk about recall.Please

[geebee]

Randy,

St. Jude had a new type of valve that came out a few years back. It had some type of coating that was a problem but I don't know the specifics.

The tried and true St. Jude that is being used right now is a model that has been around for 25 years (maybe a little fine tuning here and there) and is still going strong. I replaced my recalled Bjork-Shiley with a St. Jude almost 12 years ago and have no regrets whatsoever. It is a great valve.

[RandyL]

and what would be the model that I need to specify? Is it this new St Jude Regent?
Thanks

[geebee]

and what would be the model that I need to specify? Is it this new St Jude Regent?
Thanks
I am not familar with the Regent because I think it is only available for aortic and I am a mitral valve patient. I have just the regular St. Jude.
I think your surgeon would be the one to help you decide whether to go with the Regent or the "older" model.

[tobagotwo]

My understanding of the Silzone Tragedy:

The St. Jude Silzone valve had elemental silver embedded in the sewing cuff. Silver is a natural antiseptic and antibiotic. The St. Jude Medical Corporation thought it would reduce the incidence of endocarditis in valve recipients.

Unfortuantely, the tissue that normally grows over and around the cuff and stiching, holding it firmly in place, did not grow well on the silver-laced cuff in most people. Worse, the tissue that the valve was sewn into actually degraded in a percentage of patients. Although the valves themselves were good, they began to pull away from the tissue they were attached to, creating perivalvular leaks, sometimes catastrophic in nature. A number of recipients died from the rapid tearing away of their valves, and many more had emergency resurgeries to replace the leaking prostheses. Some of them, particularly the older and less robust patients, died from the trauma of the leakage and the too-soon resurgery.

As sad as it had become, matters then became even worse. St. Jude steadfastly failed to acknowledge that their new star performer was the cause of these tragic deaths. Some of the Silzone valve recipients who had emergency resurgeries were simply fitted with newer versions of the Silzone valve. Of course, the new valves still had the same issue. More of those valve recipients then died in the emergency re-resurgeries done to get them back to a "plain" valve, after the company was finally forced to accede to its failure and culpability. There are people on this site who lost loved ones to the Silzone disaster.

St. Jude does not make the Silzone valve anymore. You won't get one by accident, either. Hopefully, the company learned a lesson in humilty from this, a small pittance for the terrible damage and pain inflicted on so many.

The current St. Jude valves, in fact all the St. Jude valves that I am cognizant of, other than the Silzone valve, were and are safe and effective.

Best wishes,

[tobagotwo]

Briefly, insofar as I may understand the St. Jude valve models...

The St. Jude Medical Heart Valve is their standard valve.

The St. Jude Masters Series valves incorporate a rotatable collar containing the billeaflet valve, allowing easier placement. This series is also the one used in valve-plus-graft devices which replace anueristic portions of the aorta along with the valve, and models with special sewing cuffs for unusual surgical situations. The sewing cuff of the Masters Series valves is intended to be sewn supraannularly, to allow a larger valve opening.

The Regent is the most advanced St. Jude valve, used for valve-only replacements. In this model. the rotatable collar is intended to be placed supraannularly as well as the sewing cuff, allowing an even larger valve opening.

The appearance is that the Regent would be the pick of the litter, if you "only" need a valve. The Masters series would be the best pick for specialty needs and aneurism replacement.

http://www.sjm.com/devices/devicetype.aspx?location=in&type=18

Best wishes,

[Marty]

The surgeons at Inova Fairfax are very conservative. They never did let the "Silzone" onto the shelf. They still use the traditional St. Judes described in the previous excellent posts. They continue to warn against new wonder valves that have been coming on the market frequently over the years. I recently asked about the new "open pivot" ATS. The answer- it won't be known if it is better until it is tested under controlled conditions at least six years in hundreds of patients. I am happy that I was not asked to test a new valve in 1997. Remember, if you or your surgeon tries a new untested valve you may get a an improvement but then again you may get a lemon.

[lance]

RECALL!

What recall?
When was this, How in the heck do you have recall? I need to hear more about this immediately. I had mde my mind up for the St.Jude valve. I am only 2 weeks away and now you talk about recall.Please

Randy,

No need to be concerned. All silzone coated products produced by SJM were recalled in 2000.

They were associated with paravalvular leak and thrombus formation causing the death of some recipients.

If you google for silzone SJM you will see page after page of lawsuits worldwide.

[Marty]

I blame the surgeons who are always looking for the newest untried valve modification for the silzone fiasco as much as I do the company. Our surgeons waited for others to be the test subjects and for that I am grateful. I was a control.
In about six years we will know if the ON-X,ATS, etc. are as good or possibly better than the tried and true St. Jude , Carbomedics, or Medtronics
valves.
Our surgeons strongly advise against abandoning warfarin for aspirin no matter what the ATS salesmen say. If you wish to help advance medical knowledge and willingly with informed consent become a test subject OK; but, if you wish to be a control let your surgeon know that too!

[Marty]

Hi Marty,

Not just surgeons, but any person involved in the sale (SJM) and approval (FDA, Health Canada, etc.), purchasers (hospitals) are all equally responsible for their part in the silzone fiasco. Surgeons most of all because they were trusted by their patients to practice medicine in accordance with the oath they took when they were licensed--namely the Hyppocratic Oath. You know how it goes--first to do no harm or something similar.

Maybe those surgeons should take a refresher course some time and re-acquaint themselves with basic ethics.

That's why I respect our surgeons. I sort of feel for St.Jude in that they believed Silzone would do away with post op endocarditis. To this day I am not sure the percentage of patients that got in trouble with the silzone valve Janie or Billie might know.My impression from the original study was that it was pretty low. But if it happens to you or a loved one it is 100%.

[Nancy]

Joe's surgeon is conservative also. Said he never even saw one (silzone).

[twinmaker]

I have a St. Jude mechanical mitral valve. It was implanted back in 1981. It turned 24 this past August and is still going strong. When I had it implanted, the valve had not been approved by the FDA and I had to sign tons of paperwork to use it, but I am so glad that I did. My surgeon gave me a choice, but going with an older valve would mean having another surgery in the future and with the St. Jude mitral, who knows...maybe I won't have to go through a third OHS. Here's hoping! LINDA

[Marty]

I have a St. Jude mechanical mitral valve. It was implanted back in 1981. It turned 24 this past August and is still going strong. When I had it implanted, the valve had not been approved by the FDA and I had to sign tons of paperwork to use it, but I am so glad that I did. My surgeon gave me a choice, but going with an older valve would mean having another surgery in the future and with the St. Jude mitral, who knows...maybe I won't have to go through a third OHS. Here's hoping! LINDA

Thank you Linda. By the time I came along they knew the valve was OK!

[twinmaker]

Thank you Linda. By the time I came along they knew the valve was OK!
You're welcome, Marty, but I don't feel that I did anything to be thanked for. At the time, I felt like I might be signing my life away, but after having had one OHS and facing number two, I knew I didn't want to do it a third time if there was any chance that I might not have to. So I guess I was really going with the St. Jude for selfish reasons. My surgeon convinced me that if it was his wife in my position, he would recommend the St. Jude and that was enough for me. Linda

[lance]

Hi Marty,

SJM placed silzone coated valves and other appliances on the market in spite of inadequate research and testing of the silver coating.

SJM did not issue the recall voluntarily--they were forced to. Their only concern was the profit they expected to make. SJM has endangered the health of thousands of silzone patients around the world.

SJM does not deserve sympathy--not mine, not anyone's.

Now I'm off my soapbox.

Cheers

[Baldrick]

Hi Marty,

SJM placed silzone coated valves and other appliances on the market in spite of inadequate research and testing of the silver coating.

SJM did not issue the recall voluntarily--they were forced to. Their only concern was the profit they expected to make. SJM has endangered the health of thousands of silzone patients around the world.

SJM does not deserve sympathy--not mine, not anyone's.

Now I'm off my soapbox.

Cheers

I'll stay off the soapbox but this, for me, is really the heart of the issue. I really don't think that St. Jude would knowingly produce a defective valve and anybody can make a mistake. But when it's become obvious that you've made a mistake, you need to admit it. Goodwill intangible assets on the balance sheet are not worth more than peoples' lives.

[Marty]

Hi Marty,

SJM placed silzone coated valves and other appliances on the market in spite of inadequate research and testing of the silver coating.

SJM did not issue the recall voluntarily--they were forced to. Their only concern was the profit they expected to make. SJM has endangered the health of thousands of silzone patients around the world.

SJM does not deserve sympathy--not mine, not anyone's.

Now I'm off my soapbox.

Cheers

Lance, I accept your point. However I would like to know how many silzone valves were implnted and how many patients died or needed repeat surgery. Is there any way to find this out? Look, I am a radiologist, a specialist in women's imaging, which includes the high risk mammography and OB-Gyn sonography tests. I have had suits filed against me but so far have never been convicted of malpractise or had to settle. When the suits were filed I wanted to reach out to the patients, say I was sorry, and try to find out exactly what went wrong. The lawyers always ordered me to not do any of this.
I bet it was St. Jude lawyers who made them play hardball with the patients, and I think that's bad.

[Marty]

C
Eur J Cardiothorac Surg 2004;25:371-375
© 2004 Elsevier Science NL

--------------------------------------------------------------------------------



The Silzone effect: how to reconcile contradictory reports?
Gary L. Grunkemeier*, YingXing Wu
Providence Health System, Portland, OR, USA

Received 11 September 2003; received in revised form 3 December 2003; accepted 15 December 2003.

* Corresponding author. Address: Providence St Vincent Hospital and Medical Center, 9205 SW Barnes Road, Suite 33, Portland, OR 97225, USA. Tel.: +1-503-216-7272; fax: +1-503-216-7274
e-mail: gary.grunkemeier@providence.org


Objective: To attempt to reconcile reports containing contradictory findings with the St. Jude Medical Silzone heart valve. Methods: Major leak and thromboembolism data were extracted from available Silzone valve studies. Linearized rates were used to summarize and compare the events rates among the studies. Results: The Artificial Valve Endocarditis Reduction Trial (AVERT) study reported significant higher rate of major leak and the Cardiff Embolic Risk Factor Study (CERFS) reported significant higher rate of thromboembolism with Silzone compared to non-Silzone valves. But, current updates of these studies show a diminution of these differences. Three other comparative studies reported no difference between Silzone and non-Silzone valves, and three single arm studies reported acceptable results with Silzone valves. Conclusion: The contradictory findings could be partly due to clinical and technical reasons. No new events have been reported since the original AVERT (major leak) and CERFS (mitral thromboembolism) publications.


Key Words: St. Jude Medical heart valve • Silzone heart valve • Paravalvular leak • Thromboembolism




I think this may be good news for those who are living with silzone valves. Looking into this after not thinking about it for years, I am impressed that you can get all the complications attributed to silzone such as thrombosis and paravalvular leak with regular non-silzone valves.




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[RCB]

In the development of heart valves there have been many things that didn't pan out. You have to remember that before 1960, if your valve could not be repaired- you died on the table. My first valve just lasted a couple of years, but at least I lived to get another one. At the time, many surgeons wanted to give up on valve surgery because they lost so many pts. As I posted before, one person who had a repair by my doctor the years before my surgery, stated that of the 7 children who had heart surgery the week he did, only 1 other went home. It is very hard on the surgeon to see pts. die. One only has to look at the case of the brilliant pediatric surgeon from Arkansas who killed hmself because he felt he had failed some children who died.:( So if you think that St Judes is a heartless company that thinks only about profits, you are misinformed. First of all, the mistake cost them dearly! When Bjork-Shiley made a change to their valve for improved flow, it was manufactured
with strut welds that were defective and it put the company out of business because of the lawsuits. I have read where Dr. Shiley became very depressed about all the pts. that died. I would bet that the researchers at St Judes who were trying to reduce pt. infection rates
with the silver coating idea, were horrified with what happened and I do have sympathy
for them and the company. There other valves that had fatal outcomes. Many of the single disc valves, had disc escape in to the blood stream, resulting in sure death.:eek: Tissue valve- their development did not go without some horrible losses, valves that fell apart in a matter of months!:eek: Then there was that crazy Frenchmen, who want to stick bovine parts in to people hearts:eek: - Wow I bet that went over big when he announced that stupid idea!;) The rest is history.:) You never know what is going to work in the long run.

What is the “Best valve”(trying to get thread back on track)? Is a little like asking what is the best ice cream, car, teacher, color……………etc, etc. When I had my third
Surgery in 1982, my surgeon could have gone with the new kid on the block, St Judes.
He decided against it, because with twice as many moving parts, twice as many things could go wrong and no one had demonstrated it had superior flow characteristics. He could have gone with the new and improved Bjork-Shiley CC(the one with the bad welds), but he was more like Marty, he would let someone else try the new valve- after all he had already tried 2 new ones on me and figured I had paid my dues! So I got the old tried-and-true Bjork-Shiley 60 degree valve. Was it the best valve? It was certainly
better than the CC type, maybe not as good as the St. Judes- but as my team at CCF decided during my last surgery- “any valve that is in place and doing well should be left
there.” For my other valve, they put in a Carbo-Medic. They couldn’t put the St Judes
Regent in that position. Could they have put a ATS or ON-X in? I’m sure if they felt one or the other was clearly a superior valve, they could have called up one of the companies and they would have sent a chartered jet and a team of surgeon to get CCF to try their valve. Like Marty, my previous surgeon Dr. Kay, the team at CCF will take a wait and see approach. That way, you might not get what may prove to be the best valve
of the future, but a sure thing right now- and hopefully not a defective product.

The “best valve”? What are your criteria? The longest lasting valve is the Starr-Edwards; some of them are approaching 40 years. It will be 15 years before any St. Judes will match that! I’m sure the St. Judes will and more. One poster had an old Kay valve that had been in place for 32 years and doing fine- hard to argue that is not the “best valve” for that poster. It will take years to sort out the answer to this question and I’ll be
willing to bet by the time they know which one is clearly superior (if they ever do), it will
replaced by something even better.:(

Get a surgeon you trust, let him make the call based on which valve he feels the most skilled at implanting.:)

[Marty]

We have some contributors who have silzone valves and they are four years out. Looks like they are good to go!

Marty,

The problems with the Silzone valve seem to have been limited to a very small subset of patients, and seem to have disappeared by about 2-4 years after surgery. Since all Silzone patients are now at least 5 years beyond their surgery, they should have complication risks similar to a non-Silzone St. Jude valve which, as you know, are very low.

Based on new follow-up information, we recently submitted another paper, titled "Time-related Risks of the St. Jude Silzone Heart Valve". Below is the majority of the abstract to that paper, with some of the technical stuff snipped out:

Objective: The St. Jude Medical (SJM) Silzone heart valve was introduced in 1997 with a silver-impregnated sewing ring designed to reduce the incidence of endocarditis. Recruitment to the randomized AVERT study comparing Silzone valves with non-Silzone Control valves was stopped because of an increased risk of reoperation for paravalvular leak, but patient follow-up continues. Determining the time-related risk profile of the Silzone valve is necessary to help physicians and surgeons manage the approximately 28,000 patients currently living with a Silzone valve.

Methods: From 1998 to 2000, 403 Silzone and 404 Control patients were enrolled in AVERT. As of July 2005, there were 1,819 Silzone and 1,842 Control patient-years of follow-up (mean 4.5 years, median 5.1 years in both groups).

<snip>

Conclusions: The additional risks of the Silzone valve, compared to Control, diminish over time and disappear by 4 years after Implant. The minimum time post implant of the patients currently alive with Silzone is now beyond 5 years, so these current patients have a risk profile similar to that of a standard SJM valve.

Hope this helps. Tell Ed Lefrak 'hello' for me.

Gary G.


-----Original Message-----
From: MThomas52@aol.com [mailto:MThomas52@aol.com]
Sent: Thu 12/29/2005 5:48 PM

[Marty]

In the development of heart valves there have been many things that didn't pan out. You have to remember that before 1960, if your valve could not be repaired- you died on the table. My first valve just lasted a couple of years, but at least I lived to get another one. At the time, many surgeons wanted to give up on valve surgery because they lost so many pts. As I posted before, one person who had a repair by my doctor the years before my surgery, stated that of the 7 children who had heart surgery the week he did, only 1 other went home. It is very hard on the surgeon to see pts. die. One only has to look at the case of the brilliant pediatric surgeon from Arkansas who killed hmself because he felt he had failed some children who died.:( So if you think that St Judes is a heartless company that thinks only about profits, you are misinformed. First of all, the mistake cost them dearly! When Bjork-Shiley made a change to their valve for improved flow, it was manufactured
with strut welds that were defective and it put the company out of business because of the lawsuits. I have read where Dr. Shiley became very depressed about all the pts. that died. I would bet that the researchers at St Judes who were trying to reduce pt. infection rates
with the silver coating idea, were horrified with what happened and I do have sympathy
for them and the company. There other valves that had fatal outcomes. Many of the single disc valves, had disc escape in to the blood stream, resulting in sure death.:eek: Tissue valve- their development did not go without some horrible losses, valves that fell apart in a matter of months!:eek: Then there was that crazy Frenchmen, who want to stick bovine parts in to people hearts:eek: - Wow I bet that went over big when he announced that stupid idea!;) The rest is history.:) You never know what is going to work in the long run.

What is the “Best valve”(trying to get thread back on track)? Is a little like asking what is the best ice cream, car, teacher, color……………etc, etc. When I had my third
Surgery in 1982, my surgeon could have gone with the new kid on the block, St Judes.
He decided against it, because with twice as many moving parts, twice as many things could go wrong and no one had demonstrated it had superior flow characteristics. He could have gone with the new and improved Bjork-Shiley CC(the one with the bad welds), but he was more like Marty, he would let someone else try the new valve- after all he had already tried 2 new ones on me and figured I had paid my dues! So I got the old tried-and-true Bjork-Shiley 60 degree valve. Was it the best valve? It was certainly
better than the CC type, maybe not as good as the St. Judes- but as my team at CCF decided during my last surgery- “any valve that is in place and doing well should be left
there.” For my other valve, they put in a Carbo-Medic. They couldn’t put the St Judes
Regent in that position. Could they have put a ATS or ON-X in? I’m sure if they felt one or the other was clearly a superior valve, they could have called up one of the companies and they would have sent a chartered jet and a team of surgeon to get CCF to try their valve. Like Marty, my previous surgeon Dr. Kay, the team at CCF will take a wait and see approach. That way, you might not get what may prove to be the best valve
of the future, but a sure thing right now- and hopefully not a defective product.

The “best valve”? What are your criteria? The longest lasting valve is the Starr-Edwards; some of them are approaching 40 years. It will be 15 years before any St. Judes will match that! I’m sure the St. Judes will and more. One poster had an old Kay valve that had been in place for 32 years and doing fine- hard to argue that is not the “best valve” for that poster. It will take years to sort out the answer to this question and I’ll be
willing to bet by the time they know which one is clearly superior (if they ever do), it will
replaced by something even better.:(

Get a surgeon you trust, let him make the call based on which valve he feels the most skilled at implanting.:)

I believe the " old curmudgeon" said it all. This should be required reading for all pre-op valvers.

[Mary]

Although the Silzon controversy seems to have died down and Marty's last post is reassuring for those who still have the valves implanted, some additional information might be shared regarding St. Jude's culpability for its introduction of the silzone valve. A documentary produced by Ulster television was made available on DVD to valve replacement members. The documentary appeared to be well researched and factual, and, as I recall, set forth some of the following points:

The patent on the old St Jude valve was due to expire, if a modification was made to the existing valve, a new patent could be obtained.
The company had no research statistics to back up the claim that silzone was effective against endocarditis. They planted the prototypes in five sheep and one of the sheep died. That was a 20% failure rate. They planted the valve in 19 patients in Northern Ireland and four died......that also was close to 20% failure rate.

St Jude applied to the FDA for a 'materials change' licence for the new device instead of the much longer process of having a new device approved.
It is asserted that to avoid potential punitive damage lawsuits, St Jude sent the first valves to Europe for testing. This is common practice and is considered a cheap way of testing new devices and new drugs. In a memo produced in court, a member of the St Jude Medical marketing team referred to Europe as 'The guinea-pig Continent.' Unfortunately, some of the "guinea pigs" died as a result.

It is not widely known but St Jude does not manufacture their own valves. They are manufactured under licence by Sultzer-Carbomedics. Obviously, as Sultzer-Carbomedics had all the equipment to manufacture the old St Jude valve, the expiry of the patent would allow them to use this equipment to manufacture the same device and market it under their Sultzer-Carbomedics name, probably at a much cheaper price and hence greatly reducing St Jude's profits.

Finally the documentary interviews a Valve Replacement member about the death of his wife following her mitral valve replacement with the silzone valve. She was the first to die in Northern Ireland. Following her death the silzone valve was explanted at autopsy. St Jude did not ask to see the explanted valve and to this day, the valve and her entire heart organ remain in the Pathology department in The Royal Victoria Hospital in Belfast.

[Marty]

Wow, Mary. I never did get that DVD but have just asked Hank if he can still get me one. I reviewed some of Billy's old posts and agree St. Jude doesn't look so good. I almost can't believe they didn't want to see Myrtles valve. The only good news is that Dr. G's research suggests that those patients that survived the first few years are now no longer at risk. I wonder why those Irish surgeons were so quick to use the silzone in the first place?

[sue943]

Until I came to this site it didn't even occur to me that there was a choice of mechanical valves, I thought the choice was just tissue (and the types of) or mechanical. Then I saw that most of you have St Jude in your signatures and until reading more I thought that might be a hospital or something, then I realised it was a make of valve. Now you are telling me there are different models from a manufacturer. Oh heck, I was perfectly happy with my two ATS valves and now I don't know what to think. You are telling me that mine are unproven, that fills me with confidence. :)

[Ross]

I'm dying to do this everytime I read the thread title, so I'm doing it.

The best valve is the one that keeps you alive!

[geebee]

I remember how scared I was when I found out I had the "recalled" Bjork-Shiley valve ticking away in my chest. My first thought was, "How can you "recall" a valve that has been sewn into a patient"? Then I was angry because the recall came just before my second OHS and my surgeon knew about the recall yet he did not replace the valve. However, I found out later that, in 1982, there weren't many other choices for mechanicals. St. Jude's valve was brand new at the time. I had a fairly small valve and all the BS strut failures (at the time) were in the 27-29mm sizes (mine was 25mm). Therefore the surgeon thought it was better to leave mine in.

I have had many years to think about the problem and have less anger for Shiley than I did. I realized that they were pioneers in the field and I might have died had that valve NOT been available. Shiley was forced out of business because a great lawyer put together a huge class action lawsuit that bankrupted the company. That lawsuit has been useless to many of us who decided to have their valves explanted. I have seen no money for my third OHS because the lawyers keep coming up with excuses as to why my valve "was not in the danger group". This despite my cardio and surgeon stating that my symptoms were in line with strut failure symptoms. Sometimes class action suits work for the "class" but mostly they work for the lawyers. I apologize, in advance, if I have just insulted any lawyers out there. It was not my intention, just speaking from my experience.

Yes, maybe St. Jude was trying the Silzone valve to hold onto their patent. After all, they are in business to make money. We can all think that motivations should be purely for the "good of the world" but, if companies didn't make money, they would not be in business. Simple fact but very true. I agree with the statement that those people who worked on the Silzone valve must have felt terrible when these problems came up. I am sure the same can be said for Shiley as well. I do not, for one moment, believe these companies put out products they know will kill people. Call me naive but that is a belief I will carry to my grave.

I think it is important for us, who benefitted greatly from medical research, to be grateful for companies like St. Jude and Shiley for creating products that have kept us around. Yes, some of our members had tragedies due to errors. However, if we did not have these companies, none of us would be here today.

As RCB stated, many people died in the early stages of valve surgery. I salute those people because they made what we have today possible. I would like to think my participation in research studies when I lived in the NY area helped people too.

I am off my soapbox now. Please don't throw rocks at my head if you disagree. Know this is all simply my opinion.

[Randy & Robyn]

You are telling me that mine are unproven, that fills me with confidence. :)

Sue,

The ATS valve has been used since 1992 in nearly half a million people, it is FDA approved and has an excellent track record for performance. I would say it has proven itself quite well to be every bit as good as the St. Jude. I would not worry about it in the least.

Randy

[sue943]

Thank you for that, I feel much better. :)

[Mama2Rylan]

I just had my OHS in August, so my St. Jude is still "new & fresh"..I didn't get a choice though. They were suppose to replace my aortic valve, but for complicated reasons, they left the valve in it's place and just "attached" a conduit instead. The conduit already has a St. Jude inside of it...does anyone know if there are conduits with other "brands" of mechanical valves:confused: