New member with the usual dilemma

[JoeWanderer]

Unfortunately I'm not familiar with anyone in the EU. A quick search brought up Maximiliaan L. Notenboom, BSc (Erasmus University Medical Center, Rotterdam, the Netherlands), however. I don't think he is currently a surgeon but his name is listed on one of these long term Ross outcome studies, he may be able to point you in the right direction if it's something you wish to pursue.

https://esc365.escardio.org/person/1166520

I assume you've found this one already, but anyway here goes the link: https://www.schuechtermann-klinik.de/medizin-pflege/herzchirurgie/ozaki-operation/

According to the AVNeo website it's the closest hospital to the Netherlands that performs the procedure. I lived in Germany for a few years (some 2 hours away from where this hospital is, actually) but have long since come back home, if I still were in D I'd at least try to schedule a consultation with them (though I find it curious that they have such skills in a "Dorf" in the middle of nowhere). Though I admit that reading the procedure's description scares me a bit - it's crazy that such "tissue reuse" even works!

 

[Teapotimus]

To clarify, the point of my post was "if you match this clinical description (young, male, pure AR, dilated annulus), be wary of the Ross procedure (unless you have access to these three or four guys who do it very well.)"

I agree with this, and there's abundant research to back up this viewpoint. Interestingly the original description of the Ross procedure technique from Dr. Ross was mostly abandoned during the initial excitement of the procedure. Unsurprisingly the few surgeons who utilized his technique and improved upon it are the ones posting these exceptional results. While the myriad of surgeons who attempted it in easier less complex ways drove the procedure into the fringe territory. I recently read a very interesting paper on a large number of Ross series, and out of all of them only 1 utilized the technique that was originally described and is used today by the surgeons I listed. Unsurprisingly that series had significantly better outcomes than all the others.

The variable durability results of the autograft procedure may
also partly be explained by the surgical technique and by
individual variation of the application of the root replacement
technique.
The subcoronary implantation technique was abandoned
by most centers for multiple reasons, including its technical
complexity and the attractive option of the root replacement
technique that preserves the geometry of the autograft valve
apparatus. In the systematic review, only 1 series reports solely
on results with the subcoronary implantation technique. Thus
far, these results are excellent and offer hope for those surgeons
who are willing and able to master this technique.

I don't think every surgeon should be or is even capable of performing the Ross in a way that's best for the patient, but perhaps with adequate training and time it will become a more available option for more people should they want it.

 

[Juli]

Thank you, I'll look him up.

I've also just stumbled upon Dr Jaroslav Benedik, who's based in Germany. He's (co-)published quite a few research papers: https://www.researchgate.net/profile/Jaroslav-Benedik. He has sort of adopted and improved the Ozaki method, which he's been teaching about in EU. If anyone has any experience with Dr Benedik or the Helios Clinics (where he currently works, I believe), please let me know.

You might want to check the forum „Die Herzklappe“ which is in German. You can find postings from Dr. Bendik (@Benny) who became the chief of cardiac surgery of a clinic in the Chez Republic but still does surgery in the Helios Clinic - I think one day a month. You can also find his Email address and comments from other patients that are considering or had surgery by him.

As others have already mentioned this method is relatively new and data over outcome is in the 10-year range.

As a “proud owner” of a mechanical valve I know that the performance will not deteriorate/change over time and most likely I will not need any additional OHS. If there would be more data over the long-term outcome I would also have considered Ozaki. So far there are not many clinics/surgeons that are performing this technique - but might change over time.

 

[pellicle]

Hi

To my rather limited understanding, they remain fringe for the following reasons:

• There are strict requirements, which means fewer people actually qualify for Ross or Ozaki.

so IFF you meet them then perhaps its "equal" to the shorter duration of a bioprosthesis from the perspective of avoiding "blood thinners and maybe equal (in a period under 20 years) to the durability of a mechanical

I can find sufficient posts here where people say "if I knew what I know now I'd not have got the Ross"

• Both of these procedures are significantly more complex than the usual replacement with a mechanical valve, as some have already called out above. Therefore, there are fewer specialists who are skilled/experienced enough to perform these procedures.

complexity is nice on an expensive watch, not what you want for your first surgery and god better be on your side in redo

• They simply have not been around as long as the other procedures that are performed more frequently.

exactly, far less data which fails to show anything more than "not significantly inferior"

why place the bet of your life on that sort of "return for risk" ... but then I'm probably too conservative and safety oriented.

• Or at least that's the case with Ozaki, for sure.

I would not touch that with your barge pole.

I've never had a satisfactory answer to "how do they get YOUR pericardial tissue to form up a valve without

1. two surgeries
2. opening you then closing you
3. a longer opening time and on the fly manufacture of the valve leaflet

has problems written all over it ... and for what benefit (in a younger patient)?

• I do not have the data to support this, but I wouldn't be surprised if both, Ross and Ozaki, have been gradually gaining traction over the last 10 years or so.

I don't have evidence either, but irrational fear of anticoagulation (largely based on knowing things which are not correct) and "the ticking"

What if:

• you get endocarditis, both the Ross valves or just the Ozaki valve are buggered up and youo're back to square one but with (in the case of the Ross potentially two) mechanical valves or bioprosthesis valves in there and you're now one step closer to what I'd like to call roughly "three strikes and if you're not out you don't want to be there"
• what if you end up needing ACT (anticoagulation therapy or in other words blood thinners) because the Ozaki starts thrombosis formation (and of course doesn't have the durability aspect you rejected because you were against / afraid of ACT

To me its a plan that minimises good outcomes and gives you most statistical potential for downsides.

I'd pick a regular bioprosthesis before I did either of those.

Perhaps after having been around this since I was ten I've heard a few more things than you have. But then, isn't that why you came here? To listen to 先生?

https://www.valvereplacement.org/threads/endocarditis-leading-to-avr-my-story.889366/post-929467

https://www.valvereplacement.org/threads/ross-vs-mechanical.889507/#post-931541

https://www.valvereplacement.org/th...soccer-dreams-on-warfarin.888515/#post-915690

https://www.valvereplacement.org/th...edure-and-life-expectancy.887753/#post-900741

I've not seen much on Ozaki here on VR ...

Don't get me wrong, I have nothing invested in your choice and do not gain or suffer from what you pick. I'm just a genuine guy who isn't woke and speaks as I see stuff with (my definition of sanity being) minimal distortion of reality.

Before you put a line through ACT why not work out if what you "know" is only what you think you know and its overblown?

Dunno ... just thinking out aloud

Best Wishes

 

[j42195]

I assume you've found this one already, but anyway here goes the link: https://www.schuechtermann-klinik.de/medizin-pflege/herzchirurgie/ozaki-operation/

Thank you!

You might want to check the forum „Die Herzklappe“ which is in German. You can find postings from Dr. Bendik (@Benny) who became the chief of cardiac surgery of a clinic in the Chez Republic but still does surgery in the Helios Clinic - I think one day a month. You can also find his Email address and comments from other patients that are considering or had surgery by him.

What a great resource! Thank you so much. It's so nice to see the surgeon participating in some of the discussions, but also to hear other people's experience with Ozaki and other procedures that are not as frequently discussed.

I can find sufficient posts here where people say "if I knew what I know now I'd not have got the Ross"

I understand. At the same time, it's possible to find multiple people who've had issues with any of the other procedures. Or people who had issues with the anticoagulants (although I completely understand that most of the time it's very manageable) etc etc. As you have said yourself (I think?), there's a confirmation bias that we all might (consciously or not) have sometimes.

complexity is nice on an expensive watch, not what you want for your first surgery and god better be on your side in redo

Actually, thanks to the recommendation from @Juli, the info I've managed to find so far on Ozaki, suggests that the re-operation is a lot less complicated compared to the re-operation after the bio or mechanical valve. However, as has been discussed in this very thread, it's really important to work with the right surgeon, who specialises in such procedures.

I would not touch that with your barge pole.

I've never had a satisfactory answer to "how do they get YOUR pericardial tissue to form up a valve without

1. two surgeries
2. opening you then closing you
3. a longer opening time and on the fly manufacture of the valve leaflet

has problems written all over it ... and for what benefit (in a younger patient)?

There's lots of great info on the German forum shared by @Juli. I cannot recall all the details right now, but specifically remember that some specialists (e.g. Dr Benedik) perform the Ozaki procedure in a very short time. One has to keep in mind, though, that he is one of the few experts who's adopted and improved the method.

What if:

• you get endocarditis, both the Ross valves or just the Ozaki valve are buggered up and youo're back to square one but with (in the case of the Ross potentially two) mechanical valves or bioprosthesis valves in there and you're now one step closer to what I'd like to call roughly "three strikes and if you're not out you don't want to be there"
• what if you end up needing ACT (anticoagulation therapy or in other words blood thinners) because the Ozaki starts thrombosis formation (and of course doesn't have the durability aspect you rejected because you were against / afraid of ACT

You can develop endocarditis with any procedure. If the re-operation is required because of that, some specialists can perform it quickly and safely.
To clarify, I am not against ACT. In fact, reading your own experience on your blog removed some of the doubts I might have had initially, so thank you for that. But there's quite a difference between definitely needing ACT for the rest of your life and having a chance of possibly needing it should there be some complications.
As for durability, I think it would be most fair to not assume that it does not have the durability, since there are no studies to support that statement. In the same way, I don't think it's fair to claim anything about its excellent durability beyond 10 years, since there's no evidence to support that either.

Before you put a line through ACT why not work out if what you "know" is only what you think you know and its overblown?

That is precisely what I am trying to do. It somehow sounds like you're assuming that I have my mind set on Ross or Ozaki, which is simply not true. I want to learn as much as I can about all possible options and then make an informed decision. And I appreciate you sharing your point of view!

 

[pellicle]

I understand. At the same time, it's possible to find multiple people who've had issues with any of the other procedures.

it feels like you don't, because what you say feels like you totally don't get how probability and statists works.

You can roll the dice and get a 6 ... but the probability is you won't.

Sample size: there are relatively few (perahps 1% of OHS is The Ross) yet in a "random bag" I reach in and find the above examples. If The Ross was so good there shouldn't be anywhere near that. Thus I assert that you misunderstand statistics and make an error in accusing me of bias and cherry picking out bad examples.

Please find me some examples here of "my mechanical valve failed in less than two years" ... in 12 years here I've only seen one of patient prosthesis mismatch (too small a valve was used) and one of inappropriate patient selection because the patient was very contraindicated for ACT.

That is precisely what I am trying to do. It somehow sounds like you're assuming that I have my mind set on Ross or Ozaki, which is simply not true.

well firstly I haven't seen much in the way of asking about that issue (ACT) instead what I read here (not what you may be thinking, which I can't know) is you are very positively exploring a fringe procedure. I think you have also some assumptions about me which are perhaps wrong.

Perhaps I've missed all your probing questions about living with a mechanical and ACT ... but if I have, or have answered and not recalled who asked and who I was answering, please accept my apology for not paying attention. I just speak what I think is the truth in the same way to everyone.

You can develop endocarditis with any procedure

precisely, and then if you had any normal valve done you'd only have one valve to replace not two as in the Ross ... as I said, risk taken for reward. What is the reward for The Ross? You avoid ACT .... that's it.

As you (may) know I had a homograft done when I was 28, back then there was a lot of experimenting going on with respect to heart valves and the sort of things which work and to push the boundaries. I myself got a homograft in 1992. Someone elses aortic valve in my heart. I got nearly 20 years from that, so by some peoples views I should be proclaiming how good that is. Instead what I"ll say is that I was fortunate to get the top end results.

Now days I don't tell people to get a homograft, I tell people to go mainstream. I say that because:

1. statistics show that is the better way
2. availability of good surgical teams to do those procedures

As for durability, I think it would be most fair to not assume that it does not have the durability, since there are no studies to support that statement.

I'm not sure which valve you are talking about, but if we are talking about the mechanical valve there are plenty.

There is no definitive cure for valvular heart disease; you choose one of the available solutions each comes with risks and certainties.

1. bio-prosthesis risk: surgical management of disease if you live past its lifespan, eventual likelihood of requiring ACT towards the end of its life. reward: avoid ACT for some time
2. mechanical rise: poor post surgical compliance / management of ACT will create elevated risks of a bleed. reward: the valve will never fail in your lifetime.

do you see it differently? If so in what ways?

 

[pellicle]

I've managed to find so far on Ozaki, suggests that the re-operation is a lot less complicated compared to the re-operation after the bio or mechanical valve.

I'd be very interested in that link ... @Juli do you happen to have that handy? Thanks in advance Juli, I'll search meantimes...

searched: didn't find more than this

You might want to check the forum „Die Herzklappe“ which is in German. You can find postings from Dr. Bendik (@Benny) who became the chief of cardiac surgery of a clinic in the Chez Republic but still does surgery in the Helios Clinic - I think one day a month. You can also find his Email address and comments from other patients that are considering or had surgery by him.

which does not seem to address how reoperation is easier. However to be clear I wasn't talking about reoperation, I was asking "how is it made from your own tissue"

on this point:

As you have said yourself (I think?), there's a confirmation bias that we all might (consciously or not) have sometimes.

yes, exactly, and I have discussed that many times here. However what could that possibly be in my case? Firstly I'm not in the market because 12 years ago I chose a mechanical with a bental for very clear logical reasons:

1. it was my 3rd OHS and being 48 at the time I did not want a reoperation of a minefield of scar tissue and a very complex redo surgery at a later time(say 15 years, which would be 3 years from now).
2. I'd already had a homograft valve and I knew well (began researching those outcomes in 2002 ten years after my OHS #2 and well before expecting an OHS #3 (which came around in 2012)
3. my surgeon is part of the same team that had dealt with me from childhood, they had a long history of making good decisions; while in this case I was offered a choice I took about 5 seconds to make it.
4. my next meeting with my surgeon is in August and he's probably going to say something like "we don't really need to do this" but since we missed my 10 year follow up he's probably curious. My cardiologist is already pushing out our catchups to 3 or 4 years after pushing them out to 2 a couple of years back. Really, if I'd have had any other valve type then they would be bringing the monitoring back closer (not spacing them out).

I have no regrets and you won't find a single post here of me saying "I regret it"

If there are confirmation biases I can't see them.

I am however not immune to not seeing the obvious; recently I bought a new watch (a Willard Homage) and despite knowing every single stat about it I had hoped it would be different and believed somehow all the youtubers telling me "it wears more like a smaller watch"

So it arrived, it was bull5hit, it wears like the big lump it is and I'll be selling it. Such is a lot easier than a heart valve choice.

Best Wishes

 

[j42195]

Part #1:

Ok, what's with the passive-aggressive witch-hunt?
I want to re-emphasize one more time that I'm not trying to sell the Ross nor the Ozaki procedure to you. And there's nothing wrong with exploring the options that you're less comfortable or familiar with, even if I might decide not to go for any of them in the end.

Some of the answers I gave were about Ozaki rather than Ross (especially in relation to the great tip from Juli about the German message board). This was my bad, perhaps, since I now realise it would make much more sense to talk about Ross and Ozaki separately as they're, indeed, two very different procedures.

it feels like you don't, because what you say feels like you totally don't get how probability and statists works.

You can roll the dice and get a 6 ... but the probability is you won't.

I can assure you that I am very familiar with both, performing and reading statistical analysis.
However, I was referring to your previous comment, not to the statistics in this case: you previously said that you can find multiple complaints made about Ross on this message board, to which I responded that it's possible to find multiple complaints about any procedure, especially if one goes looking for it (with confirmation bias).

Comparing Ross or Ozaki to rolling a dice and expecting a 6 is just so misleading. As you'll see below, a quick search (with my own confirmation bias, I guess) reveals that it's possible to find evidence that both, Ross and Ozaki, are not significantly worse than the mechanical valve. I have not read every single word of these studies yet, though. Therefore, the truth is probably much more nuanced than that.

Ross:

1. Long-Term Survival and Mortality
   • The Ross procedure shows significantly better long-term survival rates compared to mechanical AVR. Survival rates for the Ross procedure were 96%, 94%, and 93% at 5, 10, and 15 years, respectively, compared to 90%, 84%, and 75% for mechanical AVR (Andreas et al., 2014).
   • Meta-analysis revealed a 46% lower all-cause mortality for the Ross procedure compared to mechanical AVR (Mazine et al., 2018).
2. Complication Rates
   • The Ross procedure is associated with lower rates of stroke and major bleeding compared to mechanical AVR. Specifically, the Ross procedure had a lower incidence of stroke (IRR 0.26) and major bleeding (IRR 0.17) (Mazine et al., 2018).
   • In terms of perioperative outcomes, there were no significant differences in mortality or major complications between the two procedures, although the Ross procedure had a higher rate of serum creatinine increase (Bouhout et al., 2017).
3. Reintervention Rates
   • Reintervention rates are generally higher for the Ross procedure compared to mechanical AVR. The need for reinterventions in the Ross group was associated with factors such as younger age and a larger aortic annulus diameter (Aboud et al., 2021).
4. Quality of Life and Hemodynamics
   • The Ross procedure results in better hemodynamic outcomes compared to mechanical AVR, leading to improved exercise capacity and quality of life. It was associated with lower mean aortic gradients both at discharge and at latest follow-up (Um et al., 2018).

And the following when it comes to Ozaki:

1. Long-Term Survival and Mortality
   • One study indicated no significant difference in survival at discharge and 3 months post-surgery compared to mechanical AVR (El Barbary et al., 2023). Another study reported excellent survival rates with 94.6% survival free of aortic valve insufficiency at a median follow-up of 19 months (Ríos-Ortega et al., 2023).
2. Complication Rates
   • The Ozaki procedure is associated with lower major complication rates compared to mechanical AVR. It has demonstrated lower incidences of thromboembolic events and the need for anticoagulation therapy (Krane et al., 2021).
   • Postoperative complications, such as bleeding and infection, were rare and generally manageable. One study reported a low rate of postoperative complications, including a significant decrease in mean pressure gradient at 3 months (El Barbary et al., 2023).
3. Reintervention Rates
   • Reintervention rates for the Ozaki procedure vary but are generally favorable. A systematic review indicated that the Ozaki procedure has a low rate of reintervention due to valve dysfunction (Badalyan et al., 2023).
   • Another study showed a reoperation-free survival rate of 94.6% at an average follow-up of 19 months (Ríos-Ortega et al., 2023).
4. Quality of Life and Hemodynamics
   • The Ozaki procedure offers excellent hemodynamic outcomes. It has shown better hemodynamic performance with lower mean pressure gradients and larger effective orifice areas compared to conventional prosthetic valves (Krane et al., 2020).
   • Improved quality of life and exercise capacity have been reported due to the absence of the need for lifelong anticoagulation and better hemodynamic performance (Badalyan et al., 2023).

I want to add one more time that Dr Benedik has adopted and improved the Ozaki method further and has performed over 150+ procedures by now. You can find a number of people with positive experiences with it on that same German message board. So, I think it's not unreasonable of me to try to educate myself more about it instead of blindly dismissing it.

 

[j42195]

Part #2:

well firstly I haven't seen much in the way of asking about that issue (ACT) instead what I read here (not what you may be thinking, which I can't know) is you are very positively exploring a fringe procedure. I think you have also some assumptions about me which are perhaps wrong.

Perhaps I've missed all your probing questions about living with a mechanical and ACT ... but if I have, or have answered and not recalled who asked and who I was answering, please accept my apology for not paying attention. I just speak what I think is the truth in the same way to everyone.

Correct, you have not seen me asking about the mechanical valve and ACT much at all. We've already agreed that it's an older, more widely documented and popular procedure, right? Therefore, I was able to find more information about it myself. Furthermore, I know this option will be explained again to me during the upcoming appointments.

precisely, and then if you had any normal valve done you'd only have one valve to replace not two as in the Ross ... as I said, risk taken for reward. What is the reward for The Ross? You avoid ACT .... that's it.

Having to replace two valves is certainly a disadvantage when it comes to Ross. But not the case when it comes to Ozaki.

I shared some of the potential rewards when it comes to Ross above. In addition, I'm currently looking into possible advantages of Ross when it comes to exercise performance, which I'm really interested in (papers from El-Hamamsy et al., 2018, possibly?).

And while I'm not against ACT per se, I would prefer not to have to do it for the rest of my life. But that will have to, indeed, be weighted against the pros and cons of other procedures, first.

I'm not sure which valve you are talking about, but if we are talking about the mechanical valve there are plenty.

No, I was responding to your comment about the durability of Ross and Ozaki. To reiterate, you cannot make claims about an inferior durability of, for example, Ozaki, when it simply has not been studied beyond the initial 14 years. Likewise, I cannot just claim that it's very durable beyond the initial 14 years for the exact same reason.

yes, exactly, and I have discussed that many times here. However what could that possibly be in my case?

I appreciate your detailed explanation and respect your decision-making process regarding your valve choice. However, I want to highlight that we all have a tendency towards confirmation bias sometimes, myself included, whether we like it or not.

In your case, you've favoured studies and referred to message board comments that support your decisions (as I've admitted above, I might have done the same). More importantly you've very quickly dismissed evidence and opinions that contradict your views. On the other hand, I have not made a single comment dismissing the validity of the mechanical valves and ACT.

I don't know how this escalated so fast and why I even have to feel like I'm defending myself. I did not come here looking for judgement or passive aggressive comments like "but then I'm probably too conservative and safety oriented". Nor did I come here to be scolded. Instead, I came here looking for personal advice and pointers to other resources as well as scientific evidence, which other members have kindly provided without making me feel bad about asking.

I'm already anxious about the whole situation as is, so I definitely do not want to spend more time justifying myself for trying to do my research.

---

If other members have further comments or resources to share, it'd be much appreciated. It does not have to be about Ross or Ozaki. In fact, if anyone knows of a good surgeon in the Netherlands (or nearby), specialising in the mechanical valves, please share. I think some options will be given to me in my next appointment with the cardiologist, but any pointers are very welcome.

 

[Deidra]

If other members have further comments or resources to share, it'd be much appreciated. It does not have to be about Ross or Ozaki. In fact, if anyone knows of a good surgeon in the Netherlands (or nearby), specialising in the mechanical valves, please share. I think some options will be given to me in my next appointment with the cardiologist, but any pointers are very welcome.

I don't have any info on surgeons in Europe or more info on the Ross or Ozaki.

I did just want to say that it's important to remember when reading studies about mechanical valve complications that they almost always don't account or adjust for ACT compliance or time in therapeutic range. There are many studies that show the average time in therapeutic range with warfarin is something like 50-60%, meanwhile many people on this forum spend 90%+ of their time in range.

It's reasonable to assume, and there's data to back it up, that many clots and bleeding events after mechanical valve replacement are driven by low and high INR respectively. I don't recall the name of the study, but I remember that it showed patients who self-test/manage their INR and spend a large majority of their time in range have rates of clotting identical to the general population, and rates of bleeding that were very slightly higher.

Something to keep in mind when assessing the data.

About exercise ability, I don't know. But I do know that we have people here with mechanical valves who lift very heavy weights, and bike/run long distances. A woman summited Mt. Everest with a mechanical valve. Just anecdotal but figured I'd mention it.

I hope you find a surgeon that you're happy with, and choose the option that feels the most right for you.

 

[j42195]

I did just want to say that it's important to remember when reading studies about mechanical valve complications that they almost always don't account or adjust for ACT compliance or time in therapeutic range. There are many studies that show the average time in therapeutic range with warfarin is something like 50-60%, meanwhile many people on this forum spend 90%+ of their time in range.

It's reasonable to assume, and there's data to back it up, that many clots and bleeding events after mechanical valve replacement are driven by low and high INR respectively. I don't recall the name of the study, but I remember that it showed patients who self-test/manage their INR and spend a large majority of their time in range have rates of clotting identical to the general population, and rates of bleeding that were very slightly higher.

Something to keep in mind when assessing the data.

Noted. Thank you so much!

About exercise ability, I don't know. But I do know that we have people here with mechanical valves who lift very heavy weights, and bike/run long distances. A woman summited Mt. Everest with a mechanical valve. Just anecdotal but figured I'd mention it.

This is really reassuring. Thanks again.

 

[Lucker]

j42195​

My 2 cents.
For me, Ozaki is out of question, if the annulus is large. A respectable surgeon told me that, and I see no reasons to disbelieve him here. I guess the same applies to Ross, because there will be no tissue strengthening structures in the valve.
As for the worse survival with the mechanical valves: I suspect the main reason is poor ACT management. Today we can do this much better, than say in 2014, with personal devices.
I wouldn't accuse pellicle with passive agression. After I studied and comprehended the aortic valvular disease for myself, I saw, that he is really being pragmatic. There are blatantly "yellow" advertising materials on the Internet about Ross, masked as medical articles. When I came here shortly after understanding the gravity of my situation (really not that grave, as I see it now), I was in shock, my critical thinking was impaired, but that's understandable.
That said, I would evade ACT if I could, and hope to manage this, my time hasn't come yet.
Exercise capabilities are defined by the condition of the heart muscle, so not delaying the surgery or having less valvular surgeries should contribute here.

 

[pellicle]

Hi

But not the case when it comes to Ozaki.

correct, and I was not saying that (if you read carefully). I was saying that I have no idea how they make it out of your own tissue and does that require two procedures or do they leave you open?

To reiterate, you cannot make claims about an inferior durability of, for example, Ozaki, when it simply has not been studied beyond the initial 14 years. Likewise, I cannot just claim that it's very durable beyond the initial 14 years for the exact same reason.

exactly, and I made no claims about the Ozaki and only discussed it from the perspective of its strange preponderance on making it our of your own tissuie.

as to my own biases I believe that I do everything humanly possible to be aware of them and that includes listening to and responding to when others say "I think your biased" and treating that responsibly.

I certainly got a lot of guidance on that sort of thing when I did my Masters Thesis back in 2007

Best Wishes

 

[Lucker]

I was saying that I have no idea how they make it out of your own tissue and does that require two procedures or do they leave you open

They place metal template on a piece of pericardium and cut the leaflets, then put them into glutaraldehyde for a couple of minutes, rinse, and voila.

 

[pellicle]

They place metal template on a piece of pericardium and cut the leaflets, then put them into glutaraldehyde for a couple of minutes, rinse, and voila.

very interesting ... do you know more details? For instance:

• they have cut the pericardium but I assume they have not stopped the heart or have you on bypass
• how long does it take to manfacture that in situ (with you open)
• any data on post surgical complications such as infections
• any data on the duration increase of this

Thanks

 

[Lucker]

• they have cut the pericardium but I assume they have not stopped the heart or have you on bypass - yes.
• how long does it take to manfacture that in situ (with you open) - I'd say 5-10 minutes for the leaflets.
• any data on post surgical complications such as infections - I have no reliable data. Probably the same as a biological valve.
• any data on the duration increase of this - Probably the only increase that comes from more intricate stitching of the leaflets into the place.

 

[j42195]

There are also some adjustments to the original Ozaki procedure, such as the one performed by Dr Benedik (as per this):

"<...> for example, the Benaki operation uses gauges made from the flexible material nitinol, as opposed to the rigid Ozaki gauges. Due to the special properties of this material, gauges can be modeled, giving them the desired shape and allowing more convenient measurement of the distance between the commissures, then they are also used as templates for cutting the leaf. In addition to improved meters, Benaki’s operation uses special “three-armed” forceps for the comfort of creating aortic valve neocusps [7]. Known special holding device for the formation and simultaneous plastics of the aortic valve leaflets (MAAZOUZI APS AORTIC PLASTY-SIZER). In the work of A.S. Nesmachny describes in detail the technique of using the device in clinical practice [7, 16, 19]."


In terms of duration, I found this: "The duration of cardiopulmonary bypass was 117.5 ± 14.5 minutes and the X-clamp time was 107.0 ± 14.4 minutes". But also read on that German message board that it is shorter than that when performed by someone who's more experienced in this particular procedure. It's something I'd like to look into further, though.

Also curious about your thoughts on this quote from that same surgeon:
"In my opinion the Ozaki (Benaki) valve have a lot of benefits. I suppose the construction of the valve allow not only the magnificent opening with low gradient, but the long coaptation (mainly more than 1cm) reduce the stress on commissures and through this mechanism reduce the rate of calcification. The long coaptation is sufficient puffer after enlargement of annulus, root and STJ (dilatation in follow-up – the point of criticism by aortic valve repair) – which I showed in simple experiment (re-use of the same cusps after enlargement of aortic annulus, root and STJ by 3 strips of pericardium – the valve was competent again).
The third pro – you have no struts – in case of endocarditis it is not necessary to replace the whole valve (simpler procedure)."

 

[pellicle]

Thanks ... do you have any links for this (I've turned up not much in the past, haven't given it a serious look in a few years now

• how long does it take to manfacture that in situ (with you open) - I'd say 5-10 minutes for the leaflets.

that's short and very interesting how they'd do that and make a reliable valve. Its quite a skill set to do that and I'm pretty sure it won't be most surgeon's forte.

• any data on the duration increase of this - Probably the only increase that comes from more intricate stitching of the leaflets into the place.

intricate and perhaps more than that.

Thanks

 

[pellicle]

There are also some adjustments to the original Ozaki procedure, such as the one performed by Dr Benedik (as per this):

interesting, thanks

 

[pellicle]

The third pro – you have no struts – in case of endocarditis it is not necessary to replace the whole valve (simpler procedure)."

just quickly on this point diseased native valves get removed as do diseased homografts, so I think that if the valve gets endo then struts or no struts it is out.

However with the Ozaki the only things I have in mind about it are:

• lack of data (both in number of patients and centers) as well as durability
• its still a natural product (like leather) and prone to having natural variations in thicknesses and strengths. These are the same weaknesses which contribute to such a broad range of failure Standard Deviation around the mean

I'll go read that article now.

Also, if I may, point you to some self observations I've made in the past:

I'm not good at understanding what I seem to not be pre-disposed to understand and which is illogical (yes I'm probably a bit autistic) but panic reactions have always seemed the worst and most pointless reactions. I say the worst because I've seen people killed by panic reactions. Hard to imagine worse than that.

that whole conversation (to my mind) went well and my personality type lends me well to being a data analyst, researcher and engineer. I thought your barely oblique accusation of me being biased was not particularly kind or helpful nor indeed logically justifiable given my (clearly stated) detachment. If anyone is perhaps likely to suffer from a probability of "researching to justify a decision made" rather than being impartial it is not likely to be me.

Best Wishes