Cleveland Clinic valves?

[MdaPA]

He had never heard of the Osaki either and there is not a lot of info out there in it which made me a bit leary.

It looks like the Ozaki procedure is a clinical trial at CC.

Ozaki Procedure
Ozaki Study: Aortic Valve Reconstruction Procedure using Autologous Pericardium | Cleveland Clinic

 

[ATHENS1964]

[QUOTE = "MdaPA, ανάρτηση: 906380, μέλος: 17405"]




https://www.ctsnet.org/article/aortic-valve-reconstruction-ozaki-neo-cuspidization-unicuspid-disease

 

[pellicle]

Hi

but the evidence is clear on mechanical vs tissue.

well yes, but also sort of no. The problem that I see (which is a big one) is warfarin compliance (let alone the mismanagement of patients by clinics). I've read studies which suggest as many as 50% of patients are not compliant.

Faced with that fact (meaning faced with how patients will harm themselves) I can understand why so many surgeons favor tissue "no matter what" and informed decision simply is a nice little phrase (like have a nice day at the checkout).

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3068890/

The treatment of chronic illnesses commonly includes the long-term use of pharmacotherapy. Although these medications are effective in combating disease, their full benefits are often not realized because approximately 50% of patients do not take their medications as prescribed.​

If one was to see instead that, in reality ,warfarin is given to treat a chronic illness which is "prosthetic valve disease" it becomes clearly a failure of adherence to a medication given to manage a chronic illness .

To me the problem is that "most people" want "the hand of Jesus to cure them" of their disease (without any effort on their part, other than to be "patient") when in reality what happens is the role of the surgeon is to exchange valvular heart disease for prosthetic valve disease; one is managed by medication (warfarin) the other is a recurring degenerative disease (similar to what you had before) that is only managed surgically (again).

Perhaps I see this concern for compliance mangled down the line in the poorly phrased messages that people are given on the seriousness of things with all the instructions given by the lower level functionary people down the hospital food chain. (*I say mangled but perhaps the truth was never in that and its just well meaning badly delivered ********)

 

[pellicle]

the FAA considers it bullet proof and it was easy to get back in the air.

I believe its fair to say that they consider all the modern bileaflet valves in a similar way (St Jude, Carbomedics, ATS, On-X).

 

[Cactus52]

Your correct, I had talked to two other pilots and they had chose the OnX and were happy with their choice for FAA and the one and done mentality. I personally did not want to have another reop before I retire in 13 years and this seemed like the best possible choice. Very happy with it and the INR had been in range for 5 months straight now.

 

[pellicle]

I personally did not want to have another reop before I retire in 13 years

I sincerely hope you get that wish, and your choice does give you the best chance of seeing that as a reality at your age.

 

[Unicusp]

I believe its fair to say that they consider all the modern bileaflet valves in a similar way (St Jude, Carbomedics, ATS, On-X).

Are the ATS and Carbomedics valves available in the US? I've not seen them offered nor discussed in my limited interactions.

 

[pellicle]

Are the ATS and Carbomedics valves available in the US? I've not seen them offered nor discussed in my limited interactions.

I understood that ATS is now absorbed under Medtronics and that yes Carbomedics is available in the USA ... but I think that they all have less market share than St Jude and knowing that is why On-X spent up on "advertising" its "lower INR" protocol (which IMO is essentially merely marketing)

PS I still call the ATS valve that name because the majority of its appearance in research is historical and it was called that. Eg
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4559772/

 

[pellicle]

while digging I found this interesting paper:

https://pubmed.ncbi.nlm.nih.gov/30342758/
which suggests:

Thirty-year freedom from:​

reoperation, 85% ± 5%,​

thromboembolism, 55% ± 6%,​

valve thrombosis, 99% ± 1%,​

bleeding, and 57% ± 6%, and​

endocarditis 95% ± 2%, respectively.​

​

The incidence of bleeding was 2.5% and 2.0% per patient-year for aortic valve replacement​

and mitral valve replacement, respectively.​

​

The incidence of thromboembolism was 1.6% and 2.9% per patient-year for aortic valve replacement​

and mitral valve replacement, respectively.​

pretty hard to get any significant improvement on that ... and FWIW I have an ATS (so no fanboi BS attributable to me there)

 

[Chuck C]

he mentioned that he had a tissue valve implanted. He did not know which specific brand nor why tissue was chosen. Only that it was what his surgeon recommended. He was 62 and here's the real kicker; he was already on Warfarin for other reasons!!

That sounds very insane!
Now, he will need to get a reoperation, probably about age 70 to 74, for no apparent reason. Choosing tissue did not save him from going on warfarin- he's already on it, and avoiding warfarin is the big boogie man for why they push tissue valves. Had he gone mechanical he would have had a valve that would have better than a 90% chance of outliving him.

 

[Amy]

The theory that doctors / surgeons may sort of assume patient’s warfarin noncompliance is interesting - almost like their ‘so..how ‘bout a tissue valve?’ is a test to see if you’ve done your own homework and can respond with ‘no, I think mechanical.’

!!!

Now I’m torn between unicusp’s ‘conspiracy theory’ & this.

 

[pellicle]

Now I’m torn between unicusp’s ‘conspiracy theory’ & this.

Occams' razor ...

 

[cldlhd]

It is a little surprising considering the age of some of the people posting here that they would recommended tissue. As I was going in for my surgery I was just about to turn 46 and my surgeon wholeheartedly recommended mechanical. I ended up keeping my native valve but when I told him my choice, mechanical, If the valve needed replaced he was in total agreement.

 

[cldlhd]

Hi


well yes, but also sort of no. The problem that I see (which is a big one) is warfarin compliance (let alone the mismanagement of patients by clinics). I've read studies which suggest as many as 50% of patients are not compliant.

Faced with that fact (meaning faced with how patients will harm themselves) I can understand why so many surgeons favor tissue "no matter what" and informed decision simply is a nice little phrase (like have a nice day at the checkout).

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3068890/

The treatment of chronic illnesses commonly includes the long-term use of pharmacotherapy. Although these medications are effective in combating disease, their full benefits are often not realized because approximately 50% of patients do not take their medications as prescribed.​

View attachment 887814

If one was to see instead that, in reality ,warfarin is given to treat a chronic illness which is "prosthetic valve disease" it becomes clearly a failure of adherence to a medication given to manage a chronic illness .

To me the problem is that "most people" want "the hand of Jesus to cure them" of their disease (without any effort on their part, other than to be "patient") when in reality what happens is the role of the surgeon is to exchange valvular heart disease for prosthetic valve disease; one is managed by medication (warfarin) the other is a recurring degenerative disease (similar to what you had before) that is only managed surgically (again).

Perhaps I see this concern for compliance mangled down the line in the poorly phrased messages that people are given on the seriousness of things with all the instructions given by the lower level functionary people down the hospital food chain. (*I say mangled but perhaps the truth was never in that and its just well meaning badly delivered ********)

That seems a bit surprising. I mean clearly there's a big difference between missing a day or two of your statin or skipping your anticoagulant therapy for days.

 

[dick0236]

This is an interesting discussion. I'll add an antidote that surprised me a few years ago when I was visiting pre and post-op valve replacement patients in a local hospital. Over time there were a number of younger patients, all-male, under 30, and all needle using drug addicts who had destroyed their valves using "dirty needles".......they were all given "tissue" valves When I asked one of the nursing staff why they were using tissue rather than mechanical in such young patients I was given a reason that kinda surprised me. I was told that drug addicts could not be trusted to be compliant with warfarin so they placed tissue valves in them that normally did not require ACT. That tissue valve could be expected to last a few years without ACT......by then the patient might be off drugs and could be given a mechanical valve.......or he would be dead from an "overdose". Good or bad, I think medical professionals make decisions that we would not understand.

 

[tom in MO]

There has never been a person on this forum who had their cardio and surgeon tell them they made the wrong choice. All choices are a choice for life, failure to operate is a choice for death. I chose mechanical but question that choice ever time my arthritis makes it impossible for me to do something. It's my choice of mechanical and the resultant warfarin that removes the most active drugs for arthritis from my grasp. Beware of the fact that surgeons and cardios are human and driven by the same impulses everyone is.

• From the surgeon's perspective, mechanical is one and done and tissue is repeat business. Same is true for the cardiologist.
• From the perspective of a patient who is not elderly at the time of AVR, mechanical is one and done. Tissue is slow degradation of heart performance with associated symptoms, possible risk of sudden death and reoperation as an elderly adult is definite. There is a good reason the FAA will not let Cacgtus52 fly with a tissue valve.

As an aside, in this discussion, what gave me pause was the comment "When I was in [Cleveland Clinic] ICU, someone came by and asked if I’d be interested in keeping my INR at 1.5 for a study. I said “no” right away." That seems very inappropriate and a very high pressure tactic. A patient's response to warfarin will not be known for several weeks. That's a decision that can wait until one's INR has stabilized. From a perspective of human compassion and ethical science, the ICU after OHS is the last place to be looking for volunteers for a low INR clinical trial.

 

[user 15848]

For "me" it was very hard to accept the fact i was born with a defective heart; and even harder to accept that "for me" the only repair worth doing was the one that implies taking a pill for life

And, no matter how much tavi talk goes around, i can not prevent thinking like a mathematical engineer; so here is the question: You place a screw with a nut, the screw goes bad and needs to be changed, 2 options, remove nut and screw or pull out the screw and place a nut "inside" the first nut, of course this will be smaller and the screw thinner...., and so on and so forth....

Now, engineering-mathematical question: How many nuts can you insert inside the first nut always sitting there ?

Can you be 100% the "first" nut will last for ever and accept the second one ?

Doctors are not engineers, hardly comprehend high calculus; so they are told what
they are told by BIG Pharma, simple.

For me, this Tissue valve with the TAVI rethoric; DOES have a place , but it is not the sweet blue pill

 

[Protimenow]

That seems a bit surprising. I mean clearly there's a big difference between missing a day or two of your statin or skipping your antiplatelet therapy for days.

Antiplatelet? I hope you mean anticoagulant.

I think that the thought process that some cardiac surgeons use is that by the time a tissue valve needs replacement, a non-invasive method (TAVI, TAVR) or something else would be available to repair the valve without cracking the chest.

This might actually be the case, but it's still kind of hoping that medical advancements match your expectations.

In contrast, mechanical valves last a long time (in many of us, they last a lifetime), but require warfarin for life. To me, and many others, it's not a big deal.

The issue with replacing a valve - tissue or mechanical - is the scar tissue that the surgeon has to deal with. Choosing a valve that doesn't need replacement (or replacement every decade or two), makes it much easier on the surgeon than it is to have to deal with the scar tissue when replacing a valve.

 

[Protimenow]

For "me" it was very hard to accept the fact i was born with a defective heart; and even harder to accept that "for me" the only repair worth doing was the one that implies taking a pill for life

And, no matter how much tavi talk goes around, i can not prevent thinking like a mathematical engineer; so here is the question: You place a screw with a nut, the screw goes bad and needs to be changed, 2 options, remove nut and screw or pull out the screw and place a nut "inside" the first nut, of course this will be smaller and the screw thinner...., and so on and so forth....

Now, engineering-mathematical question: How many nuts can you insert inside the first nut always sitting there ?

Can you be 100% the "first" nut will last for ever and accept the second one ?

Doctors are not engineers, hardly comprehend high calculus; so they are told what
they are told by BIG Pharma, simple.

For me, this Tissue valve with the TAVI rethoric; DOES have a place , but it is not the sweet blue pill

That's one of the things that they're saying about TAVI -- each time you do it, the opening in the valve gets smaller and smaller. At some point, the valve opening may just be too small to be practical -- at that point, the valve could be replaced with a full size tissue or mechanical. Having a TAVI doesn't preclude the possibility of valve replacement - it's just less invasive and recovery time is shorter.

For some people, this may be a good choice. For others, perhaps trusting the surgeon and hoping for a better non-invasive approach to repairing/replacing a valve may be considered to be an appropriate gamble.

 

[cldlhd]

Antiplatelet? I hope you mean anticoagulant.

I think that the thought process that some cardiac surgeons use is that by the time a tissue valve needs replacement, a non-invasive method (TAVI, TAVR) or something else would be available to repair the valve without cracking the chest.

This might actually be the case, but it's still kind of hoping that medical advancements match your expectations.

In contrast, mechanical valves last a long time (in many of us, they last a lifetime), but require warfarin for life. To me, and many others, it's not a big deal.

The issue with replacing a valve - tissue or mechanical - is the scar tissue that the surgeon has to deal with. Choosing a valve that doesn't need replacement (or replacement every decade or two), makes it much easier on the surgeon than it is to have to deal with the scar tissue when replacing a valve.

Yeah that's what I meant, fixed it.
I also think there is definitely a compromise to the idea of a valve within a valve that tavi will result in.