J
JCDavis81
My valve (a St. Jude) better be the best -- It's got to keep clicking for the next 60 years! 
Help Support Valve Replacement Forums:
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®+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,
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®+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,
K
Kathy Canistro
Valve choices
Valve choices
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
Valve choices
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
Well-known member
What's the best mech valve? My St. Jude. But you can't have it, I'm not done with it yet...
B
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.
Baldrick said:
I am new. What recall are you talking about?
Thanks,
Cooker
B
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/
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/
R
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
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
G
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.
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.
R
RandyL
and what would be the model that I need to specify? Is it this new St Jude Regent?
Thanks
Thanks
G
geebee
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.RandyL said:
I think your surgeon would be the one to help you decide whether to go with the Regent or the "older" model.
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,
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,
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,
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
Well-known member
Wonder valve or lemon?
Wonder valve or lemon?
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.
Wonder valve or lemon?
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.
SJM recalled valves in 2000
SJM recalled valves in 2000
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.
SJM recalled valves in 2000
RandyL said:
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
Well-known member
Test or control?
Test or control?
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!
Test or control?
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
Well-known member
lance said:
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
Well-known member
Joe's surgeon is conservative also. Said he never even saw one (silzone).
twinmaker
Well-known member
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
Well-known member
Linda was a guinea pig!
Linda was a guinea pig!
Thank you Linda. By the time I came along they knew the valve was OK!
Linda was a guinea pig!
twinmaker said:
Thank you Linda. By the time I came along they knew the valve was OK!
