St Jude

[zipper2]

CONSERVATIVE Surgeons are wanting to wait to examine the 20 Year Data from OTHER Surgeons before 'taking a chance' on "New Technology".

You can Have a LONG HISTORY of 'Good Enough' Performance
or you can have New Technology.

You Can't have BOTH. That's why it's a tough decision.

Take your "Best Shot" or Flip a Coin.

Maybe we will all know in another 10 years or so...

'AL Capshaw'

Thanks Al,your so good at wording it and i always played

that scene in replay ,wondering if i should have insisted

on the on-x because it is used by few other surgeons

in Edmonton,where im going.But i well be happy to have it

done and content with st.Jude for now.Thanks again for

your high epertise of knowledge and feedback of opinion for us.

zipper2 (DEB)

 

[Curtsmum]

As the valve choice is not for me but for my son then i will go for the best. I'am guessing that because the surgeon his of older years, he will be a little stuck in his ways and wants to stick with the valve he knows best, i will do some research and speak to the surgeon about the On-x but will not argue with his decsition, as personally i feel that the surgeon as a lot more experience than me and will do his best for Curtis. I don't want to start a argument about valves, as people have there own personal oppinion as what they feel is best. I really wanted to know if people who had the St Jude was happy and would still make that choice today and i guess the answer is yes.

 

[ALCapshaw2]

As I see it, the St. Jude Master's Series Valves (the ones with the 30 year track record) are GOOD Valves which have served patients well as long as they maintain proper anticoagulation levels most of the time. (and I have one, in the Aortic position)

To my mind, the On-X valves offer some reduction in Risks and complications, but those are mostly in the area of taking fairly low risks even lower.

Again, to MY mind, the BIG difference is when it is necessary to go OFF anticoagulation for invasive procedures or surgery.

Then the benefits of the On-X valve really come into play, especially in regards to the Mitral Valve which is more prone to Clot Formation than the Aortic Valve.

With over 70,000 On-X valves implanted in patients in 64 countries over the past 12 years, I think we would be hearing about any serious design problems and/or failures by now. Clearly it's not like the infamous "Silzone" valve from not so long ago. (Google "Silzone" if you want to know "the rest of the story").

I just don't buy the 'head in the sand' attitude expressed by some (Doctors and others) who try to discount this promising valve with a lame comment to the effect that it is "too new" or "too untried".

My guess is that the real reason for down-playing this (newer) valve comes down to Politics and Money, with a dash of ignorance and resistence-to-change thrown in.

 

[Marty]

Al, you are right in that it was probably eight or nine years ago that I asked Dr. Lefrak about the On-x. Next time I see him I will ask again. Its not that he hasn't changed over the years- he just wants his patients to be controls not test subjects.He was with Dr. DeBakey when valve surgery was in its infancy and has changed over the years. I'm not sure about this, but a surgeon who is comfortable implanting a St.Jude which he has done hundreds of times may be a better risk than he would be putting in an On-x the first time.Little things I am told are very important in heart surgery.

 

[Lynlw]

Maybe they doctors want to see IF the results are still as good when people have had them 15 and 20 years. I think it is kind of rude to suggest these surgeons who spend many many years of their lives going to school, and studying learning and going to many conferences ect are "'head in the sand' attitude expressed by some (Doctors and others) who try to discount this promising valve with a lame comment to the effect that it is "too new" or "too untried".
My guess is that the real reason for down-playing this (newer) valve comes down to Politics and Money, with a dash of ignorance and resistence-to-change thrown in."

because they have their own thoughts and preferences. I KNOW you believe the ON-X is the very best and appreciate your passion, but I do not think it is fair to suggest members surgeons are not doing what THEY believe is best for their patient

 

[twinmaker]

I've had my St. Jude for 27 and a half years and it's still going strong with no problems. The St. Jude valve hadn't been approved by the FDA when I had mine put in but my only other choices were valves that the surgeon felt sure would have to be replaced in the future hence we went with the St. Jude. I was 29 at the time and now I'm 56. Can't believe it's been this long. Anyway, just my two cents. LINDA

 

[Eva]

I've had my St. Jude for 27 and a half years and it's still going strong with no problems. The St. Jude valve hadn't been approved by the FDA when I had mine put in but my only other choices were valves that the surgeon felt sure would have to be replaced in the future hence we went with the St. Jude. I was 29 at the time and now I'm 56. Can't believe it's been this long. Anyway, just my two cents. LINDA

I love it when I read such inspiring stories like yours Linda and many others. May you have many more healthy years to come.

 

[Lynlw]

Also interesting about the African study, the study was first done in 2004 http://www.ncbi.nlm.nih.gov/sites/e...ez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum using 3 valves to compare. "This study was undertaken to evaluate the clinical performance of the Carbomedics, Medtronic Hall and On-X valves in the challenging setting of a Third World population with incomplete anticoagulation coverage"

the result was CONCLUSIONS: There were no significant differences in the performance of the three valves in the aortic position. In the mitral position the linearized rate of valve thrombosis was significantly higher in the Carbomedics group (p = 0.002).

2 of the authors then rewrote the research in 2006 using the same data leaving out the other 2 valves and just reporting on the ON-X results http://www.ncbi.nlm.nih.gov/sites/e...med.Pubmed_ResultsPanel.Pubmed_RVAbstractPlus

 

[ALCapshaw2]

Maybe they doctors want to see IF the results are still as good when people have had them 15 and 20 years. I think it is kind of rude to suggest these surgeons who spend many many years of their lives going to school, and studying learning and going to many conferences ect are "'head in the sand' attitude expressed by some (Doctors and others) who try to discount this promising valve with a lame comment to the effect that it is "too new" or "too untried".
My guess is that the real reason for down-playing this (newer) valve comes down to Politics and Money, with a dash of ignorance and resistence-to-change thrown in."

because they have their own thoughts and preferences. I KNOW you believe the ON-X is the very best and appreciate your passion, but I do not think it is fair to suggest members surgeons are not doing what THEY believe is best for their patient

We would all like to believe that the Doctors we consult have OUR Best Interests at Heart but I have to Question how well informed they are when I hear comments such as:

"It's too New or Untested" (from a Cardiologist and in many posts to VR.com from other members)

"You don't need one of those 'new valves'.
Stick with the 'tried and true' (meaning St. Jude)" - (AVR Surgeon)

"St. Jude is the Gold Standard" (from a Surgeon when asked if he would implant an On-X Valve )

"How about ATS?" (another surgeon)

and from a Cardio when asked if he has studied the On-X valve: "No"

I have concluded that many Doctors do NOT keep up with developments in the field of Artificial Heart Valves (for whatever reason).

Maybe the First Question we should ask potential surgeons is if they are familiar with ALL of the Valve Options... or at least what Valve Options they offer.

One of the Local Heart Surgeons only offered a St. Jude Mechanical and Bovine Pericardial Tissue Valve several years ago. His group now has a surgeon who also uses Carbomedics. That's it.

Cleveland Clinic and Mayo Clinic put their (mechanical) Valve business up for "Competitive Bid", choosing 2 'preferred valves' for each Contract Period.

Cleveland Clinic has a 'relationship' with Edwards Life Sciences (not sure if that is the full or correct name) and 'apparently' was involved in the development of their Bovine Pericardial Tissue Valve (which was actually my first valve choice... it just didn't work out for me)

I NO LONGER Believe or Expect that any given Surgeon will be knowledgable about All, or even most, of the Valve Options that are available today, or without bias.

Is that being too Jaded?

Bottom Line: As others have also found, if you have an interest in a Specific Valve (Bovine, Porcine, Mechanical) or Procedure (Ross, Repair, Aorta Replacement, Maze, Minimally-Invasive, etc.) it is best to find a surgeon with Experience using the Valve or Procedure you desire.

Corollary 1: It is unrealistic to believe or expect that any / every Surgeon will be familiar and experienced (and comfortable) with ALL of the Options available.

Corollary 2: The more difficult your situation / circumstances, the more difficult it is to choose an appropriate surgeon.

Does anyone disagree with these (hopefully non-offensive) conclusions?

 

[geebee]

Al,

I know you are a huge advocate of the On-X valve and I am sure it is an excellent valve. However, I always feel like you are saying anyone who chooses a St. Jude is making the wrong decision. To describe it as being around for 30 years with "good results" is downplaying its success. I would think it has had excellent results. I, for one, did not fair well with the "new kid on the block" back in 1980 - the Bjork-Shiley CC valve which, as we all know, was recalled after 8 years on the market with 82,000 implanted. Now, I am not saying there is anything wrong with the On-X valve; I am merely saying there is nothing wrong with choosing a valve that has been successful for over 30 years.

 

[dtread]

Also interesting about the African study, the study was first done in 2004 http://www.ncbi.nlm.nih.gov/sites/e...ez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum using 3 valves to compare. "This study was undertaken to evaluate the clinical performance of the Carbomedics, Medtronic Hall and On-X valves in the challenging setting of a Third World population with incomplete anticoagulation coverage"

the result was CONCLUSIONS: There were no significant differences in the performance of the three valves in the aortic position. In the mitral position the linearized rate of valve thrombosis was significantly higher in the Carbomedics group (p = 0.002).

2 of the authors then rewrote the research in 2006 using the same data leaving out the other 2 valves and just reporting on the ON-X results http://www.ncbi.nlm.nih.gov/sites/e...med.Pubmed_ResultsPanel.Pubmed_RVAbstractPlus

The two studies are not the same:

The 2004 Study involved 252 Valves, the 2006 Study involved 530 Valves
- The 2004 Study had 104 Mitral Valves and the 2006 Study had 242 Mitral Valves
- The 2004 Study had 44 Aortic Valves and the 2006 Study had 104 Aortic Valves
- The 2004 Study had 52 patients with Two Valves and the 2006 Study had 92 patients with Two Valves
The 2004 Study had 200 Patients and the 2006 Study had 438 Patients
The 2004 Study had 2217 Patient Years and the 2006 Study had 746 Patient Years

The above figures are for the On-X valve only

The 2004 Study is in J Card Surg, 2004, Sept-Oct; 19(5):410-4
The 2006 Study is in J Heart Valve Dis, 2006 Jan; 15(1): 80-6

All you can find online is an abstract, unless you want to pay. Next time I go to NIH I'll see if I can pick up the complete studies. They are copyrighted though. With just an abstract is is somewhat difficult to make comparisons, but given that the number of patients, the number of valves, etc. are different between the two studies it looks to me like they are two different studies.

When I had my consultation in May 2007 my Cardiologist was totally unfamiliar with On-X, and my Surgeon was only vaguely familiar with it. Where I had my surgery completed the St Jude was (and probably still is) simply the de facto mechanical valve that was used, unless a special request was made such as I did (for an On-X). After my surgery was over and I got home I discovered that my INR was stipulated to be 2.5 to 3.0 instead of 2.0 to 2.5 because my Cardiologist felt that the On-X was not as good as St. Jude so that I should have a higher INR than what is normally required for a bileaflet valve. He did not even know that it was a bileaflet valve. I think things have improved somewhat now, but it is really hard to change the status quo.

 

[Lynlw]

Well, That is your opinion I happen to believe that MOST surgeons, at least the good ones ARE interested in their patients first off. I certainly would believe them over a valve company employee when it comes to statistics and results they see and what they have learned in how many years they have been operating on patients.

 

[Lynlw]

The two studies are not the same:

2004 2006
Valves 252 530
- Mitral 104 242
- Aortic 44 104
- Two Valves 52 92
Number Patients 200 438
Patient Years 2217 746

The 2004 Study is in J Card Surg, 2004, Sept-Oct; 19(5):410-4
The 2006 Study is in J Heart Valve Dis, 2006 Jan; 15(1): 80-6

All you can find online is an abstract, unless you want to pay. Next time I go to NIH I'll see if I can pick up the complete studies. They are copyrighted though. With just an abstract is is somewhat difficult to make comparisons, but given that the number of patients, the number of valves, etc. are different between the two studies it looks to me like they are two different studies.

When I had my consultation in May 2007 my Cardiologist was totally unfamiliar with On-X, and my Surgeon was only vaguely familiar with it. Where I had my surgery completed the St Jude was (and probably still is) simply the de facto mechanical valve that was used, unless a special request was made such as I did (for an On-X). After my surgery was over and I got home I discovered that my INR was stipulated to be 2.5 to 3.0 because my Cardiologist felt that the On-X was not as good as St. Jude so that I should have a higher INR than what is normally required for a bileaflet valve. He did not even know that it was a bileaflet valve. I think things have improved somewhat now, but it is really hard to change the status quo.

I could be wrong, BUT I saw the numbers and the years of the on-x study valves were replaced Between 1999 and 2004,
so maybe Williams MA, van Riet S. did another year or 2 of valves for the ON-X 2006 study AFTER the 2004 study done by Williams MA, Crause L, Van Riet S., but since it was the same hospital, Provincial Hospital, Port Elizabeth, South Africa, I doubt they are talking about a completely different set of people.
And ON-X says it was "In South Africa, 438 On-X valve patients have been followed (95 percent) for five years"
so just as a side IF they followed up on 95% of the patients that got the valve, so that leaves about 20 people they didn't find, I've always wonderred how they were doing, or if they were alive


I do have a question, maybe it is late but how is it possible the 2004 study In the On-X series 252 valves were implanted in 200 patients Follow-up was 94% complete for a total of 2217 patient-years
but the 2006 study had twicw as many patients and valves implanted but alot less patient years?530 valves (242 mitral valves, 104 aortic valves, 92 double valves) was implanted in 438 patients Follow up was 95% complete for a total of 746 patient-years

IF it helps, in 2004 In the Carbomedics group 140 valves were implanted in 126 patients Follow-up was 89% complete for a total of 216 patient-years. In the Medtronic Hall series 224 valves were implanted in 198 patients Follow-up was 93% complete for a total of 459 patient-years. In the On-X series 252 valves were implanted in 200 patients, Follow-up was 94% complete for a total of 2217 patient-years.

 

[ALCapshaw2]

Al,

I know you are a huge advocate of the On-X valve and I am sure it is an excellent valve. However, I always feel like you are saying anyone who chooses a St. Jude is making the wrong decision. To describe it as being around for 30 years with "good results" is downplaying its success. I would think it has had excellent results. I, for one, did not fair well with the "new kid on the block" back in 1980 - the Bjork-Shiley CC valve which, as we all know, was recalled after 8 years on the market with 82,000 implanted. Now, I am not saying there is anything wrong with the On-X valve; I am merely saying there is nothing wrong with choosing a valve that has been successful for over 30 years.

Gina -

Perhaps I've not emphasized the importance of making an *Informed Choice* enough in some of my posts.

If someone is more comfortable choosing a valve with a long record of durability over a newer valve with the latest technology, I certainly don't mean to demean their choice.

Similarly, I wouldn't want to criticize anyone for choosing one of the modern Tissue Valves for whatever reason.

I would hope that their choice was based on a knowledge and understanding of the trade-offs and how their choice will affect their future life.

Everyone's circumstances are unique and for those who wish to make their own choice, it often comes down to deciding which negative aspects (and every valve has both positive and negative aspects), they can best live with.

I am a Big Proponent of the concept of "Good Enough".

The Hard Part of that philosophy is defining and determining what constitutes "Good Enough". Engineers spend a LOT of time making those comparisons and trade-offs of benefit vs cost (or risk, or whatever) in product development.

I am always pleased when I read a new member describe the Sense of Peace and Calm that comes once they are comfortable with their choice, whatever that choice may be.

'AL Capshaw'

 

[dtread]

I could be wrong, BUT I saw the numbers and the years of the on-x study valves were replaced Between 1999 and 2004,
so maybe Williams MA, van Riet S. did another year or 2 of valves for the ON-X 2006 study AFTER the 2004 study done by Williams MA, Crause L, Van Riet S., but since it was the same hospital, Provincial Hospital, Port Elizabeth, South Africa, I doubt they are talking about a completely different set of people.
And ON-X says it was "In South Africa, 438 On-X valve patients have been followed (95 percent) for five years"
so just as a side IF they followed up on 95% of the patients that got the valve, so that leaves about 20 people they didn't find, I've always wonderred how they were doing, or if they were alive


I do have a question, maybe it is late but how is it possible the 2004 study In the On-X series 252 valves were implanted in 200 patients Follow-up was 94% complete for a total of 2217 patient-years
but the 2006 study had twicw as many patients and valves implanted but alot less patient years?530 valves (242 mitral valves, 104 aortic valves, 92 double valves) was implanted in 438 patients Follow up was 95% complete for a total of 746 patient-years

IF it helps, in 2004 In the Carbomedics group 140 valves were implanted in 126 patients Follow-up was 89% complete for a total of 216 patient-years. In the Medtronic Hall series 224 valves were implanted in 198 patients Follow-up was 93% complete for a total of 459 patient-years. In the On-X series 252 valves were implanted in 200 patients, Follow-up was 94% complete for a total of 2217 patient-years.

For an explanation of patient years go to this site: http://www.wisegeek.com/what-are-patient-years.htm
Or you can Google "patient years definition", or just "patient years"
It is tied to the number of events in a study.

The 2006 study had more than twice as many patients (200 vs. 438) so they had a lot of additional folks in the 2006 study. Without looking at the actual studies it is hard to tell details. Also, the specific protocols are not provided even in the complete study itself. The way they had 252 valves in 200 patients is that some patients had two valves implanted; i.e., mitral and aortic. Others just had one valve; i.e., either mitral or aortic. The two studies probably did not run for the same length of time, and then when the events are computed with the number of patients and length of the study you get varied results for total patient years. Sounds to me like higher patient years are better than lower. I'd sure like to see the results of the 2006 study when it is finalized, since that was termed "Mid-Term Results in a Poorly Anticoagulated Population". So I presume that there will be a final report. I have a copy of the 2006 study but not the 2004 study. The study does not indicate the status of the 20 or so folks that were not followed up on. Could be that they just could not find them, or as you suggest, it could be that they died. But if they did die, there is no way of knowing what they died of and whether it was related to the valve or something else.

 

[vprnet]

Competition

Competition

Thank God for competition. Where woud we all be today without it.


Vince

BAVR witih ON-X Dec 19, 2008 (on request)

 

[Lynlw]

For an explanation of patient years go to this site: http://www.wisegeek.com/what-are-patient-years.htm
Or you can Google "patient years definition", or just "patient years"
It is tied to the number of events in a study.

The 2006 study had more than twice as many patients (200 vs. 438) so they had a lot of additional folks in the 2006 study. Without looking at the actual studies it is hard to tell details. Also, the specific protocols are not provided even in the complete study itself. The way they had 252 valves in 200 patients is that some patients had two valves implanted; i.e., mitral and aortic. Others just had one valve; i.e., either mitral or aortic. The two studies probably did not run for the same length of time, and then when the events are computed with the number of patients and length of the study you get varied results for total patient years. Sounds to me like higher patient years are better than lower. I'd sure like to see the results of the 2006 study when it is finalized, since that was termed "Mid-Term Results in a Poorly Anticoagulated Population". So I presume that there will be a final report. I have a copy of the 2006 study but not the 2004 study. The study does not indicate the status of the 20 or so folks that were not followed up on. Could be that they just could not find them, or as you suggest, it could be that they died. But if they did die, there is no way of knowing what they died of and whether it was related to the valve or something else.

Thanks for the help,I want to say the ONLY reason I brought up both studies was because I keep reading statements like "Experience with the On-X Valves in Africa with a substantial population of Non-Compliant recipients shows greatly reduced risk of Stroke compared with the older Mechanical Valve Designs in patients whose INR is NOT in
Range (ask On-X for a copy of the Study)." which according to the 2004 study is simply NOT true, I'm sure the On-x people just give the 2006 midterm report, but to be honest I never requested it.

but FWIW Yes both studys were mid term reports, I would think the 2004 would have an update soon unless they stopped that study. The 2004 was printed in Oct 2004 so the 2006 was a little more than a year later since it was printed in Jan of 2006.
Thanks I understood the more valves per person and what patient years means (unfortunately I'ven been having to read these things for 20 years) but what does not make sense to me is the patient years for the ON-X valve in the 2004 study, it seems way out of line at 200 pts/252 val for 2217 patient years especially since the carbo was 126 pts/140 val for 216 PY and medtronic had 198 pt/224 val for 459 PY


THEN the 2006 study had 438 patients/530 valves for 746 patient years. which seems close to the number for the carbo and medtronic in the 04 study , not saying the same numbers, since there were double the patients, but seem like more in the same ballpark then 2217 does, so I was kind of wonderring if perhaps the 2217 was a typo

 

[geckley]

I will answer your question the same way I did last time it was asked of me. 1st. I am an auto mechanic and I know that the chevy 350 is a motor with 50 years of proven durability. The new hot rod Ford motor is a huge piece of crap. Not saying the On-X valve is a peice of crap but I went with the one my surgeon trusted. Also with a brand new baby, no short term disability and a wife out on maternity leave, I had a few other things on my mind. Now if by some odd chance Toyota comes out with a heart valve I'll be interested in a switch. Some times informed choices are hard to make when there are too many things pulling in different directions. I know it's hard to do in this world but sometimes you have to trust your Doctor.

 

[tobagotwo]

There are some differences between the dynamics of the mitral valve and the aortic valve that may play into this. For instance, in the mitral position, the so-called "tilting-disk" valves are considered equivalvent to the bileaflet valves in safety and effectiveness. In the aortic position, they are considered clearly inferior. This is apparently because of differences in the positioning and bloodflow at the two valve sites. Along with other dissimilarities, the bloodflow is more intense at the aortic position.

So, the advantages of the On-X valve simply may not be as pronounced in the mitral position. If there is no clear advantage to one over the other in a particular position, going with the one with the longest successful track record has a certain, sensible appeal.

However, there are also differences between the two valves and the two compared auto engines. Unlike the Ford motor compared to the Chevy, the On-X siliconless pyrolytic carbon material was developed by the same fellow who created the St. Jude pyrolytic carbon.

And the engineering of the newer flow characteristics builds on knowledge that was not available when the St. Jude was designed. And there's the nonpinching hinges and softer closure that may help reduce mechanical hemolysis (damage to blood cells by the valve that can be a cause of anemia in some patients).

It should be noted that apart from the silicon-free pyrolytic carbon material, characteristics similar to those mentioned above are also available in other newer valves, such as the Sorin, ATS, and Carbomedics valves.

So is the St. Jude old hat? Well, there's something to be said for the tried and true. I would guess that the St. Jude over the years has provided more patient-hours of service (which means hours of life that would otherwise have been lost) to valve patients than any other single valve prosthesis ever produced. No one's going to beat that for a while.

My bent would be to go for the updated gear, but it's easy to see why many would prefer to stick with what has worked so reliably for so many others.

Best wishes,

 

[Curtsmum]

As Curtis as a rare defect, his mitral valve is deformed, this maybe part of the surgeons disscition to use the St Jude but i really don't know. We will look into it with great detail and when the time comes we will choose together with the surgeon. Thankyou every one for the infomation.