That Mayo Clinic video which promotes MHV over THV...

[jyg]

This one: http://mayo.img.entriq.net/htm/MayoP...articleID=4071 by Dr. Hartzell V. Schaff @ Mayo.

So I watched it fully. It was interesting but I wasn't overly impressed by the continuous stream of survival rate graphs where mechanical valve data was always on top. I've read a lot of studies by now. However, what really got my attention were the lower TE and bleeding event rates for INR self testing.

But then, in the last 60 seconds of the video, Schaff drops the bomb. He takes one last jab at TAVR predictions, attempting to trump them by predicting, in this talk from 2010 ,the success of dabigatran (pradaxa) and even claims that in 5 years no MHV patient will be on Coumadin.

The following study was funded by the company that developed dabigatran, Boehringer Ingelheim. I believe most of us are aware of the conclusion: "The use of dabigatran in patients with mechanical heart valves was associated with increased rates of thromboembolic and bleeding complications, as compared with warfarin, thus showing no benefit and an excess risk."

NEJM 9/2013: http://www.nejm.org/doi/full/10.1056/NEJMoa1300615

We're also probably aware of these: Rivaroxoban, also contraindicated for MHV. Apaxiban, also contraindicated for MHV.

Almost 4 years later, I'm under the impression that every MHV recipient is on warfarin.

MHV or THV proponents, they're all guessing. I find it ironic that the strongest factor in survival in all of this is not MHV over THV or vice versa. Its not one anticoagulant over another. Its when the patient takes a more active role in his or her own care.

 

[pellicle]

MHV or THV proponents, they're all guessing. I find it ironic that the strongest factor in survival in all of this is not MHV over THV or vice versa. Its not one anticoagulant over another. Its when the patient takes a more active role in his or her own care.

How did you reach those conclusions?

 

[tom in MO]

Actually, there is plenty of data that says warfarin with baby asprin is the best medication for preventing clotting problems in mechanical valve patients. There is also plenty of data that shows warfarin is not needed for those with a tissue valve. There is also data that says mechanical valvers can eschew warfarin and asprin and still live although with a higher risk of TE and bleeding incidents. A "higher risk" of TE and bleeding does not mean it will occur.

 

[dick0236]

. There is also data that says mechanical valvers can eschew warfarin and asprin and still live although with a higher risk of TE and bleeding incidents. A "higher risk" of TE and bleeding does not mean it will occur.

It is also possible to grab a rattlesnake in the middle of its body and not get bitten.....but I would not advise it.

 

[jyg]

Pellicle and Tom,

I think you guys read me wrong. My statement was not a comment on comparing valves or anticoagulants. It is plainly obvious that currently warfarin is the only viable anticoagulation option for MHV. Etc. What I am trying to say is that the most significant and impressive change in outcome as showing in that video were differentials between in-office vs patient-self INR testing. Other than the self-testing, I'm still convinced everything else is still a wash, which implies that opinions which lean heavily on one side are really guessing. His MHV vs THV graphs have no greater differentials than anything else I've seen in reports which say the opposite. Also, Schaff should've investigated as to why tissue valves seems to be more popular rather than guessing. If I were Schaff and believed in myself, I'd be using MHV all the time except when tissue was obvious warranted (e.g. physical or psychological issues with MHV or warfarin). Is that his current practice, then? If not, why?

And Schaff's obviously wrong prediction at the end really clouded my opinion of the rest of his claims (and when its from statistics, such claims are predictions).

I found a post on this forum where someone quoted my surgeon in 2003 predicting that in a decade we'd be getting tissue valves from our own DNA grown laboratories. Its 2013 and boy do I wish he was right This doesn't make me discount my surgeon as a surgeon, just as someone who is easily as swayed by statistics as I am. Apparently, no one is God, but God, not even heart surgeons.

 

[pellicle]

i didn't read you wrong, and you restated it again. I simply asked you to explain how you came to that conclusion.

There was nothing linking morbidity to INR, only bleed events.

Again I ask you to justify your conclusions. Surely that isn't too much to ask?
Your words seem quite strong (its a wash) so, since you have reached such strong conclusions could you perhaps cite what it was that gave you those impressions?

Sorry to ask you to explain it. But your take is quite different to mine.

 

[jyg]

i didn't read you wrong, and you restated it again. I simply asked you to explain how you came to that conclusion.

There was nothing linking morbidity to INR, only bleed events.

Again I ask you to justify your conclusions. Surely that isn't too much to ask?
Your words seem quite strong (its a wash) so, since you have reached such strong conclusions could you perhaps cite what it was that gave you those impressions?

Sorry to ask you to explain it. But your take is quite different to mine.

Pellicle,

I did explain my conclusions and how I think your focus on my words misses the point, and I still feel that that is the case. Let's exchange my word "survival" for "something going wrong". Maybe that will help, maybe not. I did explain my conclusions and how I think your focus on my words misses the point, and I still feel that that is the case. I'm sorry that we cannot seem to have a meeting of the minds. I'm OK with that.

 

[Rebecca]

I found a post on this forum where someone quoted my surgeon in 2003 predicting that in a decade we'd be getting tissue valves from our own DNA grown laboratories. Its 2013 and boy do I wish he was right This doesn't make me discount my surgeon as a surgeon, just as someone who is easily as swayed by statistics as I am. Apparently, no one is God, but God, not even heart surgeons.

In the future we will be getting heart valves that start out being made in a lab using a pig intestine that has been wash many times. Once implanted this collagen scaffold will grow patent’s own cells. http://www.cormatrix.com/PatientInformation-26 I was with a group of others and we were the first patients to visit CorMatix new lab. David Camp and Dr. Robert Matheny talk to us about what they are doing. Two people from the lab also talk to us as we tour the labs. We were in the hall looking into the lab through large glass windows. It was amazing. http://www.cormatrix.com/Newsroom-13 If someone wants to help me organizes a heart valve replacement reunion in North Atlanta send me PM. CorMatix would gladly give us a tour of their lab. I saw an echo of a baby that has one of their heart valves.

About three half years ago my husband had a heart attack (back of the heart). A few weeks ago he was having chest pains after excising at the gym. When we were in the car I decided I should drive him to the hospital. He was not having a heart attack, but they admitted him into the hospital and he had to wait until Monday for a heart cat because they only do emergency heart cat on weekends. He was asked if he wanted to be part of a study group. We do not know which stent he received because it is a blind study. This stent has been used in Europe but still have not been approve in the US. http://www.abbottvascular.com/int/absorb.html There stents will resorbs naturally into the body leaving no permanent scaffold in about two and half to three years.

 

[Agian]

Wow! When do they think these new valves will be ready?

 

[big_L]

It's a good, informative video with a lot of good information. Then (my impression) the presenter goes 'off-script' and talks about something that he was excited about that just hasn't panned out.

IMHO - the valve selection question always comes down to a personal choice. One that needs to be made by an informed patient. It usually boils down to "daily warfarin vs re-surgery". All the squabbling on the board tissue vs. mechanical is fine, as long as it's done in the interest of patient education. Beyond that, it's just arguing by those whose minds are already made up.

I think it's a given that patient self-testing of INR can help maintain the warfarin dosing in the therapeutic range.

 

[pellicle]

Hi

Pellicle,

I did explain my conclusions

no you didn't you gave them, but you didn't explain how you reached them. I can only assume you have no experience with this sort of things ... but I'm ok with that

and how I think your focus on my words misses the point

sorry, reading your words is all I can do. When you write stuff I can only read what you wrote. Not what you were thinking.

I'm OK with that.

me too, I have tried to get your to think "critically" but I guess that you remain distracted by the views you held before you started reading the evidence. You still make no effort to engage or to discuss, only to contradict what seems a rational understanding of your points.

ultimately if by "its a wash" you mean there is only a small difference between a tissue valve and mechanical valve: then yes that is right. There is only a small difference and that is why both exist.

best wishes.

 

[pellicle]

There stents will resorbs naturally into the body leaving no permanent scaffold in about two and half to three years.

now that's cool stuff!

 

[Agian]

I'm gonna try ringing these guys after the weekend. If they start making valves out of this stuff it may become a game changer. Things look promising for the next generation of valvers.

 

[pellicle]

The reason I suspect you are mistaken in your appraisal of the presentation is highlighted here:

But then, in the last 60 seconds of the video, Schaff drops the bomb. He takes one last jab at TAVR predictions, attempting to trump them by predicting, in this talk from 2010 ,the success of dabigatran (pradaxa) and even claims that in 5 years no MHV patient will be on Coumadin.

firstly he didn't drop a bomb, he just says one small statement. He says:

I suspect that it is very unlikely that will be using Coumadin in the next five years

Which is a prediction for sure, but it is as yet not 5 years past the date, and predictions based on the early data of PROACT studies and literature presented by drug companies like Boehringer Ingelheim who make Dabigatran would seem like a reasonable thing back then. It may be that nothing comes up to replace warfarin in the next 5 years from now even, but that it does not does not effect the data he presented at all.

So in your conclusions seem a little rash.

To be clear I agree with you that:

what really got my attention were the lower TE and bleeding event rates for INR self testing

and I agree that

they're all guessing

I'm uncertain that:

I'm under the impression that every MHV recipient is on warfarin.

is correct as its likely to be the vast majority, but every is not correct as far as I know.

The point I disagree with in your conclusion is this:

I find it ironic that the strongest factor in survival in all of this is not MHV over THV or vice versa. Its not one anticoagulant over another. Its when the patient takes a more active role in his or her own care.

I disagree as my understanding is that the patient taking a more active role over their own care is important in reducing TE and Bleed events. This does not effect mortality (death). Recall that *any* bleed event or TIA is considered an event ... your statement that it was ironic is unclear to me, but suggests you disagree with his views.

I agree that one anticoagulant over another is not the significant issue, but then 99% of the presentation does not focus on that point. 99% of the presentation focuses on the findings that people with mechanical valves have a higher survival rate (you know, that point he droned on about).

The remainder of the discussion was on "why" ... although the why of this is speculation. The main point is that its a consistent finding.

He presents some of what he feels are the reasons, but makes no claims. His reasons include:
*reoperation risks
* he expects to see some failures in tissue valves from 6 years and the inadequate diagnosis of TE in a tissue valver who by (incorrect) assumption does not need anticoagulation can lead to deaths (when they do need anticoagulation in the latter stages of the tissue valve lifespan)

There may be more reasons.

This is what I disagreed with in your conclusions about the study.

 

[knotguilty]

Thanks Rebecca for the info. Very interesting. Hope you and your husband are doing well.

 

[ElectLive]

...he didn't drop a bomb, he just says one small statement. He says:

"I suspect that it is very unlikely that will be using Coumadin in the next five years"

Which is a prediction for sure, but it is as yet not 5 years past the date, and predictions based on the early data of PROACT studies and literature presented by drug companies like Boehringer Ingelheim who make Dabigatran would seem like a reasonable thing back then...

Well, at best, it was a poorly researched and lazy prediction, which unfortunately raises suspicions (perhaps unnecessarily) about the rest of the presentation. He basically closes with the hope being marketed at the time by the Boehringer Ingelheim team, not an informed medical professional interpretation of fact.

I've gone over this in more detail in the past, but what it boils down to is oversimplification on his part...misapplication of incomplete evidence. As most everyone here already knows, dabigatran (Pradaxa) will certainly not be replacing valve-related Warfarin in the next two years, nor maybe even ever. The initial dosing study of dabigatran for those with mechanical valves did not even begin until 2 years after this Mayo presentation, in fact, and was quickly halted after significantly more (double or higher) stroke and bleeding events than those on warfarin. Not just bleeding, not just stroke, but both.

Even had that dosing study gone in the other direction, it would have then required a full blown randomized trial before even thinking about submitting for FDA approvals, again pending actual good results. Probably would have taken about an 8 year process. What makes me so sure? Well, the same drug went through the same process for A-Fib.

Plus, at the time of this presentation, dabigatran wasn't yet approved for A-Fib either. Of course it was close enough (Europe - trial data - FDA review underway) for Boehringer Ingelheim to have ramped up their efforts, though, so therein likely began the problem. Anyway, when FDA approval did finally come, it was very clearly not indicated as clinically better than warfarin, but non-inferior (also with big bold warnings - Not for those with Valve Problems!)...as was generally expected based on the trial data that was available at the time of this presentation. Anyone in the world (as evidenced by a prospective valve patient in Atlanta, GA at the time! :wink2 could have downloaded the full FDA review materials in fact, with all trial data, preliminary review findings, etc.

The interesting point in all of this to me is actually the other theme carrying through this thread...the relative importance of patient awareness, self-testing, etc on long term outcome. In reality, the experienced mechanical valve patients in our community are probably the least likely to benefit from a Warfarin alternative. Dabigatran is able to tip the scales in the A-Fib group because of poor patient compliance, and the trial data reinforced this. I'm oversimplifying myself a bit here, but to be brief: those with poor INR control benefited far more from Dabigatran than those with good INR control. After the FDA approval came, the consensus medical guidelines here in the US emphasized this by recommending that A-Fib patients in good control should remain on Warfarin.

So, while it won't be in two years, it may still happen one day that a Warfarin alternative is approved for all valve patients. It will not mean necessarily that it's any better, though. The dabigatran experience of the past few years seems to be showing that easier is not always safer, and individual patient factors are still the most important consideration.

PS: Pellicle, by the way...1,000+ posts in your first year, wow! If even a 1/4 of what you said was useful :biggrin2:, you've made quite the contribution to the community at large...well done! :thumbup:

 

[pellicle]

Hi

He basically closes with the hope being marketed at the time by the Boehringer Ingelheim team, not an informed medical professional interpretation of fact.

yeah, I guess that's also why he "doesn't get on the podium" at conferences (aside from the topics)

;-)

dabigatran (Pradaxa) will certainly not be replacing valve-related Warfarin in the next two years, nor maybe even ever.

I would tend to agree with that. To me the issue drug makers focus on is simplicity of maintainence over complications and reversibility. I have a mate who is a pharmacist and he tells me that many of his patients struggle to follow their drug doses. I guess that's why there are companies who deal in distribution of pre-packed and labeled drug doses for patients.

Accordingly a non-variant dose would be helpful to those corporate machines. Myself I follow the views of Heinlein

A human being should be able to change a diaper, butcher a hog, design a building, write a poetry, balance accounts, build a wall, set a bone, comfort the dying, take orders, give orders, cooperate, act alone, solve equations, analyze a new problem, pitch manure, program a computer, cook a tasty meal, fight efficiently, die gallantly.

Specialization is for insects.

Anyway, personally I think its a big ask to look for any drug which is going to attempt to undo what the body does to stay alive (clot properly). Its a complex system which we don't yet fully understand. As it is we found warfarin by accident as a naturally occurring substance.

The interesting point in all of this to me is actually the other theme carrying through this thread...the relative importance of patient awareness, self-testing, etc on long term outcome.

actually that is underplayed by many. I think its all part of the medical communitys views that our role is to be passive and their role in the white coats of power is to be the respected demi-gods.

To be sure not every doctor thinks that way, but its a well covered meme within the medical academic community. My good friend did her Masters in this area of hospital administration.

In reality, the experienced mechanical valve patients in our community are probably the least likely to benefit from a Warfarin alternative.

sort of a bit like how old time drivers don't benefit from all the stuff in cars (like automatic gearboxes) and often prefer the control of doing it themselves.

Dabigatran is able to tip the scales in the A-Fib group because of poor patient compliance, and the trial data reinforced this.

yes, fully agreed there. There is the problem that patients often aren't in a fit state to monitor their doses, longer term many lack the discipline (my 72 YO uncle for one). When I first came out of hospital I tried to do the measurement with the meter and probably a serious case of pump head had me struggling to do simple stuff like add 5 + 2 reliably.

I felt ashamed to have to ask my wife to check my doses (incase I'd goofed again after a goof) and despaired that perhaps senile dementure had set in in my forties ... fortunately my mind returned from its holiday after a few months

So, while it won't be in two years, it may still happen one day that a Warfarin alternative is approved for all valve patients.

Personally I'm not up on corporate secrets (and you can bet it would be) but I too don't see anything attractive on the horizon. And besides, I'm quite comfortable (now) with what I do to keep my INR stable with warfarin. The requirement of dialysis for reversal makes any existing alternative seem diabolical to me.

PS: Pellicle, by the way...1,000+ posts in your first year, wow!

well its a "two way street" thing. I've actively participated in the warfarin discussions because it has helped me learn and forced me to clarify my own thinking.

I have learned a lot here and so anything I put back seems fair to me.

Nice chatting with you

 

[mike dab]

The FDA commissioned a study, which will be completed next year, to test plavix and aspirin vs. warfarin. Initial results have been very promising and my surgeon is very confident it will be approved. This will give us with mechanical valves the best of both worlds; long valve life and easier management of our anti-coagulation.

There is a sizeable percentage of heart patients already taking plavix, so this should be a no-brainer for many of us.

 

[ElectLive]

The FDA commissioned a study, which will be completed next year, to test plavix and aspirin vs. warfarin. Initial results have been very promising and my surgeon is very confident it will be approved. This will give us with mechanical valves the best of both worlds; long valve life and easier management of our anti-coagulation.

There is a sizeable percentage of heart patients already taking plavix, so this should be a no-brainer for many of us.

The plavix/aspirin arm of the study was scheduled to complete March 2015, or not much longer than a year as you say, but since enrollment wasn't even completed until May of this year, my guess would be that completion gets pushed back. There is supposed to be a minimum 5 years of follow-up. Sometimes modifications are able to be made along the way, though, relative to fulfilling the patient-year requirements in other ways (longer duration of those first enrolled) and/or just scaling back the requirements (On-X has done so before) so I won't speculate on when completion will actually be...just probably a little further down the road than originally expected. There also aren't any "official" results yet that I'm aware of...or not for that arm of the study anyway, but perhaps your surgeon is just at a heart center that's part of the study, so he can speak to first-hand knowledge of his particular group? The reduced INR arm does have official interim results, though.

Yes, many would do well on plavix, but I would be careful about saying "no-brainer" for this particular protocol. One of the unexpected lessons learned from this arm of PROACT is the large percentage of patients unable to qualify, mainly due to inadequate response to either the aspirin (325) or plavix, or both...50% or more of patients somewhat amazingly, which is the reason why it took so long to complete enrollment - everyone just got switched over to the high risk group (reduced INR).