Still trying to make a final decision - my first post

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JUST-WAITING

Well-known member
Joined
Dec 28, 2010
Messages
50
Location
CENTRAL TEXAS
I am scheduled for surgery jan 17th and still trying to decide on non stinted - or stinted or ross procedure- i must make final decision by monday- non stinted may qualify for min invasive. Any one with advice is welcome- My doctors left me the options without blood thinners- and was not pushy about the Ross- due to me being 52 - even though he teaches the procedure widely- so now my time to decide has come. ANY HELP APPRECIATED !!
 
Welcome to this wonderful site, Just-waiting.
Good luck with your decision. Hopefully, you have had some good input and guidance from your surgeon in terms of your decision-making. If still in doubt, don't hesitate to ask more questions until you are comfortable with the choice.
All the very best!
 
Just-Waiting, a heart felt WELCOME to our OHS family the decision you face is very personal and varies with each person .....there is a wealth of knowledge here for now and the future .....


Bob/tobagotwo has up dated a list of acronyms and short forms http://www.valvereplacement.org/forums/attachment.php?attachmentid=8494&d=1276042314

what to ask pre surgery http://www.valvereplacement.org/for...68-Pre-surgery-consultation-list-of-questions

what to take with you to the hospital http://www.valvereplacement.org/forums/showthread.php?13283-what-to-take-to-the-hospital-a-checklist

Preparing the house for post surgical patients http://www.valvereplacement.org/for...Getting-Comfortable-Around-the-House&p=218802

These are from various forum stickies and there is plenty more to read as well


And Lynw recently added this PDF on what to expect post op
http://www.sts.org/documents/pdf/whattoexpect.pdf
 
There's a lot of information needed to make a good determination. Your age is in a nondescript bracket, where you will need at least one more replacement surgery later if you get a tissue valve, stented or unstented. I chose that route at 52, but it's just as reasonable to choose the mechanical valve route with the anticoagulation therapy. Your lifespan expectation is statistically the same for either choice, as the dangers of blood clots and anticoagulation with mechanical valves seem to balance against the dangers of reoperations with tissue valves over time.

Stented or unstented has to do with whether there is a plastic support piece put into the valve to make it keep its shape better and to avoid valve leakage from deformity under pressure. An unstented valve replaces the entire wall section where the valve was with a new valve wall section. The fact that the entire wall section is being replaced is what gives it stability. A stented valve is instead sewn into the existing arterial walls and relies on a thin, plastic stent to keep its shape, the way the metal ring around a trampoline keeps it round.

The advantage of unstented valves is that the valve should have a larger opening, because it's replacing the arterial walls, rather than fitting inside of them. However, there is a natural notch in the walls, like a little shelf, just above the aortic valve. Some of the new stented valves, like the Carpentier-Edwards Perimount Magna, are mounted with a very thin stent just behind the shelf, so the stent doesn't stick out and interfere with the flow. This is called supraannular mounting, and many of the mechanical valves also take advantage of this mounting style. As such, there is not really as much of an advantage now as there originally was for non-stented valves. The main reasons for tissue valve replacement are eventual degeneration and calcification of the valve, vegetation from infective endocarditis, and various early failures.

Best-known unstented tissue valves include the Toronto Stentless Porcine Valve (distributed by St. Jude Medical in the US), which has been shown to have an average lifespan of 10-15 years, and the Freestyle stentless valve (Medtronics), which has about 12 years of data so far, the most useful appearing to be a study at seven years, showing a reoperation rate of about 5% on mixed age participants (patient age is important in tissue valves, as the younger the patient, the shorter the valve's useful life is apt to be). The Freestyle is treated to reduce calcification, the Toronto is not. Both are porcine (pig) valves. There is a new, unstented valve made of equine pericardium, which doesn't have a lot of long-term data out, simply because it hasn't been out very long. The horse tissue valve is the ATS 3F Bioprosthetic Equine Tissue aortic valve, and it works in a different way than the other valves.

The most recognized stented tissue valves are the Carpentier-Edwards Perimount series (including the Magna) by Edwards Scientific, and the St. Jude Biocor, both of which have statistical track records of 80% or better going over 20 years in older patuients (over 65, the average age of valve repalcements). Another is the Medtronic Mosaic, which has about 13 years of data so far, with similar results for that timespan. The CEP valves are manufactured from cow pericardium (the tough tissue from around the heart), the Biocor is made of porcine leaflets with cow pericardium between them, and the Mosaic is a natural porcine valve. All have been treated to reduce calcification, and preserved in ways that do not pressure-damage the tissue being used.

There are also homografts, which are human donor valves from cadavers (animal tissue valves are called xenografts). They generally have a 15+ year lifespan, and are sometimes used for younger patients or for replacing the pulmonary valve in a Ross Procedure. Cryolife is a well-known preparer and distributor of these valves.

A couple of percutaneously implanted valves (such as Edwards Scientific's Sapien and Medronics' CoreValve devices) have been approved at this time, only for limited use. They can be used to replace an original or a replacement tissue valve if the patient's situation is sufficiently dire. They are sent though the patient's arteries with a catheter, after the original valve has been flattened by a procedure similar to balloon angioplasty. They are then expanded on a stent (or self-expand) into place, much the way a ship model can be opened up inside a bottle. This eliminates open heart surgery, but the procedure is long, has risks of its own, and there is no real data regarding how long the replacement valves will last. These are currently all made with tissue valve inserts. A relatively healthy person would not at this time qualify for this type of valve.

There are a larger number of mechanical valves on the market. They all are engineered to last beyond severl lifetimes' usage, and are usually not replaced for wearing out or failures on the valve's part. The most common are St. Jude Medical Regents and Masters series (the St. Jude is the most common mechanical valve by far), the ATS Open Pivot® Heart Valve, the On-X Life Technologies On-X valve, and the Sorin Carbomedics Top Hat (in the US, with a number of different international lines). These are all manufactured from pyrolytic carbon (one over a titanium skeleton), but have differences in hinge pivot and flow surfaces design and in their carbon manufacturing and formulations. The commonly used ones are bileaflet design, but there may be one tilting disk still on the market (tilting disk may work slightly better for mitral valve use, according to at least one study). The St. Jude has a 30+ year useful lifespan track record so far and counting. The main reasons for replacement are interfering pannus (scar tissue), blood clots on or under the valve, vegetation from infective endocarditis, or placement issues (rubbing). All these mechanical valves are reliable. Perhaps the most advanced currently on the market is the On-X, which has a carbon formulation that does not contain silicon (causes bloodflow drag) and has an anti-pannus design, intended to reduce the possibility of scar tissue interfering with its leaflets.

The Ross Procedure is generally used on younger people, but it still works at 52, and has been done successfully on much older folks. If your valve problem is caused by a bicuspid valve and you show any other signs of enlarged ateries (tendency toward aneurysms), you should take that into account. It can be an indication that your pulmonary valve may eventually fail you in the aortic position due to myxomatous (weakened) tissue that can be associated genetically with those other two issues. I'm sure your surgeon has considered that, so you should ask him or her about it.

Here is one good site for looking at valve surgery information (Cleveland Clinic): http://my.clevelandclinic.org/heart/disorders/valve/valvetreatment.aspx . Obviously, a site like this forum is good for getting a real feel from others who have been through the procedure or helped others close to them through it.

Whatever you choose to do, embrace it and don't look back. As has often been said on this forum, the only bad valve decision is no decision.

Best wishes,
 
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There's a new article entitled "Hancock II Bioprosthesis for Aortic Valve Replacement: The Gold Standard of Bioprosthetic Valves Durability?" by Tirone E. David, MD, Susan Armstrong, MS, Manjula Maganti, MS, in Ann Thorac Surg 2010;90:775-781, abstract at ats.ctsnetjournals.org/cgi/content/abstract/90/3/775? . I think it's convincing that the long-used Hancock II "pig" valve (at least when it's implanted here in Toronto) has been demonstrating better longevity than any other tissue valve. The CEPerimount and the new and presumably improved Magna variation on the CEP (both "cow" valves) have demonstrated good longevity, but definitely not as good as the Hancock II.

On the other hand, another study (2007) seems to prove that the CEP Magna has superior hemodynamics to the Hancock II, like "stentless performance in a stented valve". Those hemodynamics probably don't matter to somebody with an average-sized Aortic valve, but would be important in a small valve. It's probably possible that the Magna's superior hemodynamics will translate into even-better-than-Hancock-II longevity, but there's no evidence yet. And the "logical" relationship between excellent hemodynamics and excellent durability doesn't get much support from the evidence to date, as far as I can see.

There's always going to be a tradeoff between the newest valve type, and the type that has demonstrated a great 20-year durability record, because that second one is going to be more than 20 years old! Based on my pretty careful reading of a faxed copy of that "Gold Standard" article, I'm persuaded that the Hancock II really does seem to be the Gold Standard, for demonstrated tissue-valve durability. On average, of course, since we're all just "anecdotes", and there are no guarantees here, as far as the eye can see.

Good luck with your decision, and your surgery!
 
Your lifespan expectation is statistically the same for either choice, as the dangers of blood clots and anticoagulation with mechanical valves seem to balance against the dangers of reoperations with tissue valves over time.

Can you provide the source for the statistics you cite? I would like to know the sample size, ages of folks (at implantation and at death), their physical condition, how long they were tracked, mortality, position of the valve (aortic, mitral, or other), reason for dying, etc. I would expect that a lot more elderly folks get tissue valves. The mortality of tissue valve recipients would thus be expected to probably be more related to other causes rather than their heart valve. Statistics are generalizations, and every individual is unique. I would want to see it broken out by age for every year comparing mortality for tissue vs mechanical (i.e., age ~25 through ~90).

Also, the mortality rates for reoperations should be considered. In this case we're talking about a 52 year old person facing their first operation. That is one statistic. When the reoperation rolls around 12 - 20 years later (i.e., at age 64 - 72), what are the statistics like at that point, with the increased complexity and increased risk with the advanced age? There would need to be some data showing how many of the tissue valvers had reoperations, and the data for their mortality, etc.

What we're talking about here is a relatively flat risk over time with mechanical. With tissue, we're talking slightly lower risk for a period of time, then a huge risk when the reoperation occurs, then another period of slightly lower risk, etc. A dramatically different risk profile.
 
Can you provide the source for the statistics you cite? I would like to know the sample size, ages of folks (at implantation and at death), their physical condition, how long they were tracked, mortality, position of the valve (aortic, mitral, or other), reason for dying, etc. I would expect that a lot more elderly folks get tissue valves. The mortality of tissue valve recipients would thus be expected to probably be more related to other causes rather than their heart valve. Statistics are generalizations, and every individual is unique. I would want to see it broken out by age for every year comparing mortality for tissue vs mechanical (i.e., age ~25 through ~90).

Also, the mortality rates for reoperations should be considered. In this case we're talking about a 52 year old person facing their first operation. That is one statistic. When the reoperation rolls around 12 - 20 years later (i.e., at age 64 - 72), what are the statistics like at that point, with the increased complexity and increased risk with the advanced age? There would need to be some data showing how many of the tissue valvers had reoperations, and the data for their mortality, etc.

What we're talking about here is a relatively flat risk over time with mechanical. With tissue, we're talking slightly lower risk for a period of time, then a huge risk when the reoperation occurs, then another period of slightly lower risk, etc. A dramatically different risk profile.


It doesn't have everything you want, but here is a study http://circ.ahajournals.org/cgi/content/full/116/11_suppl/I-294 Very Long-Term Survival Implications of Heart Valve Replacement With Tissue Versus Mechanical Prostheses in Adults <60 Years of Age
under conclusion
"In this cohort of adult patients <60 years of age followed for >20 years after AVR or MVR, the use of a tissue versus a mechanical prosthesis at initial implant was not associated with a significant difference in long-term survival, despite higher reoperation rates with bioprostheses. Our experience therefore suggests that a mechanical prosthesis may not necessarily be warranted in the younger adult patient population in need of first time, single left-heart valve replacement".

Most studies I see and most stats for REDOs , at least for centers/surgeons with alot of experience in REDOs show the 2nd surgery stats pretty much the same as a first OHS about 1-2% or less.
I'm pretty sure the stats for mechanical show 1-2% for a major bleed event and another 1-2% risk of clot/stroke event for people whose INR is managed well in range most of the time altho the risk of bleeding is higher for "elderly patients"
 
There's a new article entitled "Hancock II Bioprosthesis for Aortic Valve Replacement: The Gold Standard of Bioprosthetic Valves Durability?" by Tirone E. David, MD, Susan Armstrong, MS, Manjula Maganti, MS, in Ann Thorac Surg 2010;90:775-781, abstract at ats.ctsnetjournals.org/cgi/content/abstract/90/3/775? . I think it's convincing that the long-used Hancock II "pig" valve (at least when it's implanted here in Toronto) has been demonstrating better longevity than any other tissue valve. The CEPerimount and the new and presumably improved Magna variation on the CEP (both "cow" valves) have demonstrated good longevity, but definitely not as good as the Hancock II.

On the other hand, another study (2007) seems to prove that the CEP Magna has superior hemodynamics to the Hancock II, like "stentless performance in a stented valve". Those hemodynamics probably don't matter to somebody with an average-sized Aortic valve, but would be important in a small valve. It's probably possible that the Magna's superior hemodynamics will translate into even-better-than-Hancock-II longevity, but there's no evidence yet. And the "logical" relationship between excellent hemodynamics and excellent durability doesn't get much support from the evidence to date, as far as I can see.

There's always going to be a tradeoff between the newest valve type, and the type that has demonstrated a great 20-year durability record, because that second one is going to be more than 20 years old! Based on my pretty careful reading of a faxed copy of that "Gold Standard" article, I'm persuaded that the Hancock II really does seem to be the Gold Standard, for demonstrated tissue-valve durability. On average, of course, since we're all just "anecdotes", and there are no guarantees here, as far as the eye can see.

Good luck with your decision, and your surgery!

Here is an article (just the abstract) comparing Hancock II and Perimount done around the same time, but in Ottawa, that used both valves at their center, so the comparisions are pretty much apples to apples
Long-term clinical and hemodynamic performance of the Hancock II versus the Perimount aortic bioprostheses
http://circ.ahajournals.org/cgi/content/short/122/11_suppl_1/S10

Methods and Results—Between 1990 and 2007, 1659 patients (mean age, 73.1±9.3 years) underwent aortic valve replacement with either the Hancock II (N=1021) or the Perimount (N=638). Patients were prospectively followed-up with serial clinic visits and echocardiograms for up to 16 years (mean, 5.0±3.3 years). There was no significant difference in aortic root size preoperatively (P=0.7). Aortic root enlargement was more commonly performed with the Perimount (P<0.001), and the manufacturer valve size of the implanted prosthesis was larger with the Hancock II (P<0.001). Postoperatively, peak and mean transprosthesis gradients were higher for the Hancock II (32.7±0.7 and 16.0±0.3 mm Hg, respectively) than for the Perimount (24.9±0.7 and 13.4±0.4 mm Hg, respectively; P<0.001). However, no difference in left ventricular mass regression was observed at late follow-up (P=0.9). Unadjusted 10-year survival was 59.4%±2.4% for the Hancock II and 70.2%±3.8% for the Perimount (P=0.07). Multivariable predictors of survival did not include prosthesis type (P=0.2).

Conclusions—For the same manufacturer valve size, the Perimount is larger, which may warrant enlarging the aortic root more often, and it is associated with better hemodynamics than the Hancock II. These differences do not impact survival or left ventricular mass regression, and the long-term clinical performances of the Hancock II and Perimount bioprostheses are equivalent"
 
Good catch, Lyn, though the abstract has me confused. First, it seems to put a lot of weight on "manufacturer valve size" of the valves. Once I found out that the manufacturers were inconsistent in their sizing, I lost all interest in the manufacturer valve sizes, so I don't know why the researchers care about it.

Secondly, I'm puzzled that "Aortic root enlargement was more commonly performed with the Perimount (P<0.001)", though I think I've seen it before. Both of these valves come in a complete range of sizes, so I'd expect the surgeons to make a judgment about enlarging the patient's AR -- or not -- based on patient-specific criteria, not valve-specific criteria. E.g., if I had an unusually small AR, and would be prone to a "patient–prosthesis mismatch" unless I had AR enlargement, I'd expect my surgeons to enlarge my AR. Do you understand why the choice of a pig or cow valve changes the likelihood of AR enlargement?

Finally, although they find no statistical significance in the difference in survival numbers -- and especially no significant link to "prosthesis type" -- the raw difference isn't small, so I'm curious about what the other "predictors" look like. E.g., did they tend to give the CEPs to younger or healthier patients, who would be expected to survive longer?

BTW, do you understand "left ventricular mass regression" to mean the extent to which the patients' over-developed and thickened LVs "bounced back" and lost mass post-op, after their bad AV was replaced with a good one?
 
Hi there "just waiting" from another Texan here. You've gotten excellent comments to your questions and I wish you all the best as you travel the road to better health. If you're near Austin, there are other Austin folks on here too!
 
Good catch, Lyn, though the abstract has me confused. First, it seems to put a lot of weight on "manufacturer valve size" of the valves. Once I found out that the manufacturers were inconsistent in their sizing, I lost all interest in the manufacturer valve sizes, so I don't know why the researchers care about it.

Secondly, I'm puzzled that "Aortic root enlargement was more commonly performed with the Perimount (P<0.001)", though I think I've seen it before. Both of these valves come in a complete range of sizes, so I'd expect the surgeons to make a judgment about enlarging the patient's AR -- or not -- based on patient-specific criteria, not valve-specific criteria. E.g., if I had an unusually small AR, and would be prone to a "patient–prosthesis mismatch" unless I had AR enlargement, I'd expect my surgeons to enlarge my AR. Do you understand why the choice of a pig or cow valve changes the likelihood of AR enlargement?

Finally, although they find no statistical significance in the difference in survival numbers -- and especially no significant link to "prosthesis type" -- the raw difference isn't small, so I'm curious about what the other "predictors" look like. E.g., did they tend to give the CEPs to younger or healthier patients, who would be expected to survive longer?

BTW, do you understand "left ventricular mass regression" to mean the extent to which the patients' over-developed and thickened LVs "bounced back" and lost mass post-op, after their bad AV was replaced with a good one?

Who know's why so many people who had the hancock II died that wasn't related to their valve, could just be they all had bad luck and had cancer or swine flu or something. Its hard to guess from abstracts (for me at least) I really like being able to look at graphs ect.

the abstract for the "gold standard" makes me think of alot of questions too

METHODS: From 1982 to 2004, 1134 patients underwent aortic valve replacement (AVR) with Hancock II bioprosthesis and were prospectively monitored. Mean patient age was 67 +/- 11 years; 202 patients were younger than 60, 402 were 60 to 70, and 526 were older than 70. Median follow-up was 12.2 years and 99.2% complete. Valve function was assessed in 94% of patients. Freedom from adverse events was estimated by the Kaplan-Meier method

RESULTS: Survival at 20 and 25 years was 19.2% +/- 2% and 6.7% +/- 2.8%, respectively, with only 34 and 3 patients at risk. Survival at 20 years was 54.9% +/- 6.4% in patients younger than 60 years, 22.7% +/- 3.3% in those 60 to 70, and 2.4% +/- 1.9% in those older than 70 (p = 0.01). Structural valve deterioration developed in 67 patients aged younger than 60, in 18 patients aged 60 to 70, and in 2 patients older than 70. The freedom from structural valve deterioration at 20 years was 63.4% +/- 4.2% in the entire cohort, 29.2% +/- 5.7% in patients younger than 60 years, 85.2% +/- 3.7% in patients aged 60 to 70, and 99.8% +/- 0.2% in patients older than 70 (truncated at 18 years). Repeat AVR was performed in 104 patients (74 for structural valve failure, 16 for endocarditis, and 14 for other reasons). At 20 years, the overall freedom from AVR was 65.1% +/- 4% for any reason, 29.8% +/- 5.4% in patients younger than 60 years, 86.8% +/- 3.3% in patients 60 to 70, and 98.3% +/- 0.6% in patients older than 70.

CONCLUSIONS: Hancock II bioprosthesis is a very durable valve in patients 60 years and older and is probably the gold standard of bioprosthetic valve durability in this patient population."


So if they started with 202 patients were younger than 60, 402 were 60 to 70, and 526 were older than 70- and at 20 years the Survival was 54.9% +/- 6.4% in patients younger than 60 years, 22.7% +/- 3.3% in those 60 to 70, and 2.4% +/- 1.9% in those older than 70 (p = 0.01). (or 19.2% +/- 2% of the total group of 1134 people who got the valves)

Math is not my strong point, but then there doesn't seem to be many people left out of the 500 they started with who were over 70 if 2.4% +/- 1.9% survived and it looks like they stopped counting them at 18 years (which makes perfect sense since not alot of people make it to over 90 anyway) and probably around 100 patients left alive from the 402 60-70 group and 100 from the <60 (which is a HUGE category)
But of the people still alive Structural valve deterioration developed in 67 patients aged younger than 60, in 18 patients aged 60 to 70, and in 2 patients older than 70

I find it interesting the conclusion was it is the "gold standard" as far as tissue for patients "over 60", it makes me wonder what the results looked like for the patients under 60 that the Hancock II wasn't specified as the gold standard for them too.
Its a shame I'm too cheap to pay for articles


I am curious do you know when they first started using the Hancock II? I thought it was around the same time as the Perimount but from a couple of your post it seems like it was much earlier? Did your surgeon mention the Mosaic at all?

Anyway, my guess is both valves are really good and should help people live long happy lives
 
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It doesn't have everything you want, but here is a study http://circ.ahajournals.org/cgi/content/full/116/11_suppl/I-294 Very Long-Term Survival Implications of Heart Valve Replacement With Tissue Versus Mechanical Prostheses in Adults <60 Years of Age
under conclusion
"In this cohort of adult patients <60 years of age followed for >20 years after AVR or MVR, the use of a tissue versus a mechanical prosthesis at initial implant was not associated with a significant difference in long-term survival, despite higher reoperation rates with bioprostheses. Our experience therefore suggests that a mechanical prosthesis may not necessarily be warranted in the younger adult patient population in need of first time, single left-heart valve replacement".

Most studies I see and most stats for REDOs , at least for centers/surgeons with alot of experience in REDOs show the 2nd surgery stats pretty much the same as a first OHS about 1-2% or less.
I'm pretty sure the stats for mechanical show 1-2% for a major bleed event and another 1-2% risk of clot/stroke event for people whose INR is managed well in range most of the time altho the risk of bleeding is higher for "elderly patients"

This study has several items that should be noted, most notably:

“May not be generalizable to most recent tissue and mechanical prostheses, whose materials, design, and accessory technologies, such as anticoagulation monitoring, have continuously improved, especially considering that most of the valves reported on in this study are no longer commercially available”

“Some prostheses, like several Ionescu-Shiley (tissue) and Bjork-Shiley (mechanical) models, were associated with higher-than-expected failure rates.”

“Valve reoperation, often for prostheses that are no longer commercially available, occurred in 89% and 84% of patients by 20 years after tissue aortic and mitral valve replacement, respectively, and was associated with a mortality of 4.3%.”

“For nearly all patients in this cohort, anticoagulation was initially managed by the surgeon, and subsequently by the cardiologist or primary care physician. This does not necessarily represent optimal management by use of a home-monitored or telephone-monitored system. It is possible that newer anticoagulation monitoring may improve outcomes and quality of life, particularly in mechanical valve patients.”

I really fail to see the relevance of this study of the statistics of antiquated valves and poor anticoagulation monitoring to what we have today. This study ran from 1969 to 2004 and thus represents valve implants that happened in the 1970’s, 1980’s, 1990’s, and the first four years of the 2000’s, and must have included ball and cage and tilting disc valves. It also included the Bjork-Shiley, which was famous for strut failures leading to an untimely death of the patient. It’s okay if you want to hang your hat on: “The statistics show that if you get one of the discontinued ball and cage or tilting disc valves, and have poor anticoagulation monitoring, the statistics show that your longevity is the same as if you get a tissue valve”.

Okay, I admit I’m being biased here as I would presume the study also includes some bileaflet mechanicals as well as the ball and cage and tilting disc valves. But this study just represents technologies and methods that are so out of date that in my opinion it just doesn’t have much relevance. Lastly, the reoperation mortality of 4.3% for the tissue valvers is another eye opener, but I knew it had to be a lot higher than for the first operation.
 
SNIP
I'm pretty sure the stats for mechanical show 1-2% for a major bleed event and another 1-2% risk of clot/stroke event for people whose INR is managed well in range most of the time altho the risk of bleeding is higher for "elderly patients"

Lyn - can you find a reference for your 1-2% major bleed comment?

I'm thinking that is probably pretty old data (i.e. BEFORE the INR method of testing / monitoring was developed in the early 1990's). Poorly Trained and/or Out-of-Date anticoagulation managers are unfortunately still one of the major Risk Factors for patients on anticoagulation medications.

I seem to recall reading something less than a 1% bleeding event rate but don't remember where I saw that.
 
This study has several items that should be noted, most notably:

“May not be generalizable to most recent tissue and mechanical prostheses, whose materials, design, and accessory technologies, such as anticoagulation monitoring, have continuously improved, especially considering that most of the valves reported on in this study are no longer commercially available”

“Some prostheses, like several Ionescu-Shiley (tissue) and Bjork-Shiley (mechanical) models, were associated with higher-than-expected failure rates.”

“Valve reoperation, often for prostheses that are no longer commercially available, occurred in 89% and 84% of patients by 20 years after tissue aortic and mitral valve replacement, respectively, and was associated with a mortality of 4.3%.”

“For nearly all patients in this cohort, anticoagulation was initially managed by the surgeon, and subsequently by the cardiologist or primary care physician. This does not necessarily represent optimal management by use of a home-monitored or telephone-monitored system. It is possible that newer anticoagulation monitoring may improve outcomes and quality of life, particularly in mechanical valve patients.”

I really fail to see the relevance of this study of the statistics of antiquated valves and poor anticoagulation monitoring to what we have today. This study ran from 1969 to 2004 and thus represents valve implants that happened in the 1970’s, 1980’s, 1990’s, and the first four years of the 2000’s, and must have included ball and cage and tilting disc valves. It also included the Bjork-Shiley, which was famous for strut failures leading to an untimely death of the patient. It’s okay if you want to hang your hat on: “The statistics show that if you get one of the discontinued ball and cage or tilting disc valves, and have poor anticoagulation monitoring, the statistics show that your longevity is the same as if you get a tissue valve”.

Okay, I admit I’m being biased here as I would presume the study also includes some bileaflet mechanicals as well as the ball and cage and tilting disc valves. But this study just represents technologies and methods that are so out of date that in my opinion it just doesn’t have much relevance. Lastly, the reoperation mortality of 4.3% for the tissue valvers is another eye opener, but I knew it had to be a lot higher than for the first operation.

That's pretty much the problem with all long term studies or even studies, by the time anything is followed for a decade or 20-30 years and written up, there are new and better materials and ways of doing things. But that's what you have to deal with when trying to make decisions,If you want to go by stats. Its also why I try to read many studies and not rely on just 1 or 2 to make decisions, see what the trends look like and of course I rely quite a bit when I have to make choices on talking to the actual doctors and surgeons who are doing alot of the current research and involved in a few clinical trials so know alot about the most up to date stats they are working on that aren't written up yet because they are still doing the studies.
But since this study is from 2007 it is one of the more recent ones.

As for what valves yes of course they had alot of older valves BOTH for mechanical and tissue (for example there were 17 SJM mechanical and 2 CE tissue valve) especially for the 1st surgery http://circ.ahajournals.org/cgi/content/full/116/11_suppl/I-294/TBL2M681429
They discuss the fact some of the valves aren't in use so also just looked at the valves used when they wrote the study in 04

"Within AVR Patients
Figure 2 (top) displays the survival of adults under age 60 at first AVR, according to the type of prosthesis that they received at their first valve operation. Twenty-year and 25-year survival were 65.5±3.2% and 51.7±4.8%, respectively, in AVR patients initially implanted with a tissue prosthesis, and 52.3±4.4% and 41.2±5.2%, in those with a mechanical prosthesis. The independent risk factors for mortality were age, coronary disease, atrial fibrillation, and earlier year of surgery (Table 3). The choice of a tissue versus a mechanical prosthesis was not associated with a significant difference in survival. These analyses were repeated and restricted only to patients implanted with currently available prostheses as denoted on Table 2, and the choice of a tissue versus a mechanical prosthesis again did not influence survival. Similar analyses restricted to patients <50 years of age at initial AVR were also performed and did not show a significant difference in survival (HR: 0.8, initial AVR tissue versus mechanical in adults <50 years old; 95% CI: 0.5, 1.2; P=0.3)."

Just like the REDO rate of 4.3 includes all REDOs in that time frame, when the stats for REDOs have gotten MUCH better (especially in the last 10 years). Also the 4.3 is for ALL REDOs not just 1st REDO
There were 277 valve reoperations in the study cohort during the follow-up period: 198 patients underwent reoperation once, 33 twice, 3 patients had 3 reoperations, and 1 patient had 4 reoperations

There are quite a few studies the rate for 1st REDO is about the same as a first surgery, especially in centers that do alot of them..I spent alot of time looking into this when Justin was going for both his 4th and 5th OHS)

Since you mentioned this sentence "Some prostheses, like several Ionescu-Shiley (tissue) and Bjork-Shiley (mechanical) models, were associated with higher-than-expected failure rates.”
and how that might have made the stats for mechanical worse in your comment "It also included the Bjork-Shiley, which was famous for strut failures leading to an untimely death of the patient. It’s okay if you want to hang your hat on: “The statistics show that if you get one of the discontinued ball and cage or tilting disc valves, and have poor anticoagulation monitoring, the statistics show that your longevity is the same as if you get a tissue valve”.

FWIW there were 4 Bjork-Shiley (mech) valves used 2 AVR 1MVR and 1 DVR (to be fair I'm not sure if the double was 1 patient with 2 B-S or 1 patient
that 1 of the valves was a B-S)
and there were quite a few of the Ionescu-Shiley tissue 136 AVR 86 MVR 13 DVR

so it probably is not making the mech stats much different
 
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Here is another study for the Mechanical versus bioprosthetic valve replacement in middle-aged patients its from 2006 but starts much later than the other study January 1977 and July 2002 so mainly uses much newer mechanical valves (not many of the newer tissue valves)
Medtronic Hall 101 (23.9%) 91 (33.6%) 6.4 ± 4.4
St. Jude 130 (30.7%) 89 (32.8%) 5.1 ± 3.8
Carbomedics 99 (23.4%) 36 (13.3%) 4.3 ± 2.9
MCRI On-X 10 (2.4%) 6 (2.2%) 1.3 ± 0.6

tissue
Homograft 28 (6.6%) – 3.3 ± 3.0
Medtronic Hancock 46 (10.9%) 42 (15.5%) 5.9 ± 5.5
Edwards Pericardial 9 (2.1%) 7 (2.6%) 1.3 ± 1.9



http://ejcts.ctsnetjournals.org/cgi/content/full/30/3/485
I personally find it a little confusing because it focuses on MAPE
"A composite outcome of major adverse prosthesis-related events (MAPE) was defined as the occurrence of "reoperation, endocarditis, major bleeding, or thromboembolism"
Long-term outcomes after valve replacement surgery, including survival and freedom from reoperation, were compared between patients with mechanical and bioprosthetic valves. Prosthesis-related complications were recorded according to the Guidelines for Reporting Morbidity and Mortality after Cardiac Valvular Operations [5]. Briefly, stroke was defined as the presence of a neurological deficit lasting more than three weeks and was confirmed with computerized tomography of the head [4,5]. Bleeding events were classified as major if they required surgery, hospital admission, blood transfusion, were intracranial in location, or caused death. Reoperation was defined as any operation that repaired, altered, or replaced a previously operated valve [3,5]. In an attempt to provide an overall comparison of major morbidity between mechanical and bioprosthetic valves, a composite outcome termed major adverse prosthesis-related event (MAPE) was developed, defined as the composite outcome of any reoperation, major bleeding, thromboembolic event, or endocarditis during late follow-up
(so a reop counts the same as a stroke ect)

Anyway their conclusion in discussion was
The ultimate aim of heart valve surgery is to extend life expectancy and improve quality of life. This study demonstrated that amongst middle-aged patients, survival does not appear to be affected by the type of prosthesis. These results confirm those reported by others who have also found that the choice of prosthesis does not have a significant effect on survival after valve replacement in patients younger than 65 years of age [7,8]. Regarding quality of life, Perchinsky et al. studied the quality of life of 200 patients aged 51–65 years who had undergone either mechanical or tissue AVR 2–12 years earlier. Postoperatively, the quality of life was equivalent between the two groups and was comparable to the general population for the same age group [9]. Mechanical valve patients were more bothered by valve sounds, were more concerned about the frequency of medical visits and blood tests, and were more worried about the possibility of anticoagulant-related bleeding events. Bioprosthetic valve patients, on the other hand, were more fearful of the need for reoperation. Nevertheless, 97% of patients reported that they would make the same decision again with regards to valve replacement, with no significant difference between the two groups [9].
 
Norm, I haven't run into that study on the Hancock II before, or numbers quite that good for it, but I can confirm that I've heard the Hancock valve mentioned as the gold standard for the previous wave of valves. Plainly, it deserves more credit than I offered it, as it's still being used.

The Mosaic was intended to be the next step up by Medtronics. It uses the same stent type as the Hancock II, which was made thinner for more blood throughput, and of course, has an anticalcification additive and non-damaging fixation process. The difference in blood flow sizing between the Mosaic and the CEPM and Hancock II is largely attributable to the supraannular positioning of the CEP and Hancock II valves, which the Mosaic doesn't use.

Dan, I appreciate that you want the source for the statement that they have similar lifespan outcomes. It's a generally accepted statistic in the medical world. Sources for it have been posted in the forums a number of times (including by me), and can be found with a search. It's the basis for the more common use of the biological valves in younger patients. Of course it includes mortality statistics from reoperations, as well as mortality from warfarin use and blood clots, which are the achilles heel of mechanical valves.

There are many misconceptions about the risks from warfarin, making it sound worse than it is, including a bizarre issue with most dentists, although no one on ACT (anticoagulation therapy) has ever been known to bleed to death from a dental procedure. However, if you search the forums, you will find a number of discussions regarding warfarin risks because they do exist. There are also a number of explanations that the risk is constant, but not cumulative in the sense that most people seem to think.

Warfarin is a miracle drug, but it is not innocuous. An example for intracranial bleeding - http://www.ncbi.nlm.nih.gov/pubmed/16385291 :
A prospective cohort study at our institution demonstrated a 48% mortality rate in warfarin anticoagulated trauma patients sustaining intracranial hemorrhage (ICH) compared with a 10% mortality rate in nonanticoagulated patients. Forty percent of patients demonstrated progression of their ICH, despite anticoagulation reversal, with a resultant 65% mortality rate. Seventy-one percent of these patients initially presented with a Glasgow Coma Scale (GCS) score > or = 14 and a 'minor' ICH.
and an example for trauma - http://www.theheart.org/article/1014363.do :
Adjusted for gender, age, race, injury severity, treatment center, and other comorbidities, the mortality risk ratio for warfarin vs no warfarin was 1.72 overall and 1.38 for patients over 65...Dossett highlighted the impact of warfarin on traumatic-brain-injury (TBI) patients. The unadjusted mortality rates for TBI patients were 64% for patients on warfarin and 43% for patients not taking warfarin. The adjusted risk ratio associated with warfarin in TBI patients was 1.26 overall and 1.46 in patients under 65...The overall unadjusted mortality rate for traumatic injuries in the study was 9.8% for patients on warfarin and 4.8% for patients not on warfarin. The overall mortality risk ratio associated with warfarin was 1.51 for patients under 65 and 1.41 for older patients.
There are also risks for GI bleeds, and there is the risk of stroke from blood clots created by the valve. Warfarin is always in the top ten reporting drugs for adverse reactions, and has been number two in numerous years.

This isn't being posted to be scary. Considered rationally, it isn't scary. As pointed out in my post and others since, these risks are no greater than the risk of reoperations that tissue valve owners experience over time. But sometimes the ordinariness of taking warfarin dosages at home can lull people into believing that there is hardly any actual risk at all associated with Coumadin, and that simply isn't the case.

The great thing about the mechanical valve is the valve itself, which is a stunning, engineering marvel. The unfortunate part is that mechanical valves have a tendency to create blood clots that cause strokes, and the medicine to control that tendency can create bleeding hazards, and is occasionally volatile in its effectiveness.

Again, not at all a diatribe against Coumadin, but just pointing out how the risks become level over time in all the studies.

Best wishes,
 
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Nice work, all, especially Lyn! Here are some answers to your Qs (way up above now!) about the Hancock II "Gold Standard" study, which I have in a fax copy (being, like you, too cheap to spring for online full-text copies!):

1) Re: "do you know when they first started using the Hancock II?" "This valve was introduced in September 1982, and the first implant was in a patient in our institution [8]." They also say "Follow-up was a mean duration of 12.4 years (median 12.2 years; range, 0 to 27 years) and was 99.2% complete. Most patients (94%) had multiple echocardiographic studies to assess valve and heart function." Later in the study (p. 779), they say "The Hancock II has been in use since 1981. . .", without any further explanation. A typo for 1982? Or maybe "in use" includes animal studies??

2) Re: "I thought it was around the same time as the Perimount but from a couple of your post it seems like it was much earlier?" I don't have the dates on the CEP, but this study says "We could find no published reports on the durability of the [CEP] . . . at 20 years. Banbury and colleagues [3] reported its durability up to 15 years. . ." So based on that, I'm guessing that the CEP is around 5 years newer than the Hancock II.

3) You wrote "But of the people still alive Structural valve deterioration developed in 67 patients aged younger than 60, in 18 patients aged 60 to 70, and in 2 patients older than 70" -- but those SVD numbers were NOT confined to patients who are still alive.

4) Re: your "I find it interesting the conclusion was it is the "gold standard" as far as tissue for patients "over 60", it makes me wonder what the results looked like for the patients under 60 that the Hancock II wasn't specified as the gold standard for them too." The short answer is "I don't know." Obviously, the freedom from SVD stats are much worse in the younger cohorts, which makes the "gold standard" claim more hollow. But I don't see any evidence in the Comment section, suggesting that any OTHER tissue valve has lasted as long or longer in the <60 group. Dunno.

I can find no analysis of the "shape" of the <60 population, other than that the youngest was 19. They do say the patients were a mean age of 67 +/- 11 years (range 19-94), and it's possible that a good statistician could tease out that info from that statistical distribution in combination with the size of the three age "tranches". Not me.

I've mentioned before that I find this study (and most similar ones) frustrating, because no attempt is made to "slice" the valve-durability or life-expectancy data in the way that would obviously be most helpful to a PATIENT. We are all at SPECIFIC ages, and we are all curious about the best-guess, best-fit estimate of our average expectations if we follow one of the choices we have available -- in this case, getting a Hancock II valve in the Aortic position. With the data they collected, it would be easy to produce those best-guess, best-fit estimates for each year of age at operation, or at least for (say) 5-year slices. Of course the data would be uncertain statistically, and even more uncertain if taken as a guarantee of our futures, but it would be much more helpful than having a 19-year-old (or a 59-year-old) try to figure out his expectation from the under-60 numbers!

The study also NEVER compares mortality or life-expectancy numbers to those of the population as a whole, which would also be a useful comparator. It's always sobering for a full-grown (65-y-o) guy to look at his life-expectancy numbers, but if those numbers post-AVR are essentially equivalent to those who HAVEN'T had valve replacements, my reaction will be quite different! (I suppose I could check with the actuarial tables myself, but that seems way harder -- call me lazy if you must!)

Re: "there doesn't seem to be many people left out of the 500 they started with who were over 70. . ." They comment several times on the paucity of "patients at risk". E.g., there are only THREE patients, of any age, who are still "at risk" after 25 years, which is why they don't present 25-year stats. That's largely because the patients were an old crowd in the OR, lots of them had nasty health on their way into the surgery, and relatively few got their valves 25 or more years ago. They do give an analysis of the cause of death of all the patients (622 of 1134) who've died, including Cox regression analysis of all the Independent Predictors of Death of All Causes -- including Age, Hypertension, COPD, NYHA class IV, LVEF <-.40, PVD, Renal failure, and Coronary artery disease. Each has a Hazard ratio + 95% C.I., and a p Value.

Finally, there's one stat that's interesting in the context of other discussions we're having now, about ACT and mechanical valves:
Thromboembolism
During the follow-up, 124 patients sustained thromboembolic complications (89 stroke and 34 transient ischemic attacks), of which 15 patients had two events and 2 patients had three vents. Thirty-one patients died as consequence of a stroke.
The linearized rate of thromboembolism was 1.20% / year/ Independent preductors of thromboembolism were age older than 60 years, previous stroke, peripheral vascular disease, and preoperative CHF. The freedom from thrombembolic complication at 10, 15, and 20 years was 88.8 +/- 1.2%, 82.1 +/- 1.7%, and 77.3 +.- 2.3%, respectively. There was no documented case of valve thrombosis.
I don't know how to compare these clot-stroke risks with the risks I've seen from mech-valve ACT, nor do I know if the latter are INCREMENTAL to the "background" risk of clots and strokes that we all faced, before our OHS. . .
 
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