New member with the usual dilemma

[Lucker]

pellicle
Here's the first video result from the google - the article and the surgery video. The surgeon here doesn't use template though, which is the original method.
https://www.ctsnet.org/article/aort...nt-using-treated-autologous-pericardium-ozaki

 

[pellicle]

pellicle
Here's the first video result from the google - the article and the surgery video. The surgeon here doesn't use template though, which is the original method.
https://www.ctsnet.org/article/aort...nt-using-treated-autologous-pericardium-ozaki

thanks ... very interesting ...

 

[j42195]

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.

I did not consider that, thank you.

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.

I need to address a few points that I feel strongly about. Firstly, your dismissive attitude toward my comments and findings was uncalled for. You assumed I wasn't interested in safety, compared these procedures to a roll of dice, and tried to school me on statistics without knowing my background. My only aim has been to learn about newer procedures, and your approach wasn't kind.

You admitted you haven't looked into Ozaki in recent years, yet you initially approached the discussion with preconceived notions about Ozaki, jumping to conclusions without being open to contrary opinions. This contradicts the unbiased, logical approach you pride yourself on. I have not dismissed the value of mechanical valves or judged your personal choices. My goal is simply to explore all potential alternatives.

Despite claiming detachment, you seemed rather keen and interested in discouraging my research. Other members have expressed their discomfort with procedures like Ross and Ozaki while maintaining a truly detached stance, without the need to scold me for exploring alternatives.

Having said that, I'd like to apologize if my comments offended you. Despite this contentious exchange, I do appreciate the wealth of knowledge you bring to the discussion. I really do.

 

[Deidra]

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.

Huge agree with this. There is no 100% consistent way to detect underlying connective tissue disorders, as the full range of genetic mutations that cause them is unknown. I tested negative on an aortopathy genetic panel, and yet clearly I had some kind of connective tissue disorder that is probably localized to my aortic root and valve. If the root/annulus is not properly stabilized (probably not possible in all cases) in patients where this is the case (generally young, male, pure AR, dilated root/annulus), I would be extra suspicious about long term durability, personally. Maybe there are a handful of surgeons out there who can make it work, but that's not a very good elevator pitch is it.

As for the worse survaval with the mechanical valves: I suspect the main reason is poor ACT management. Today we can do this much better...

Huge agree with this as well. One cannot look at the data from these studies about mechanical valves and make blanket statements about what any one person can expect. There are so many variables, and ACT compliance/management is a huge one that seems to often get overlooked by the people writing these studies.

There are blatantly "yellow" advertising materials on the Internet about Ross, masked as medical articles.

The fact that there is literally an entire website dedicated to espousing the benefits of the Ross procedure left a really bad taste in my mouth. If you look at the bottom of the page, the website is owned by CryoLife (now Artivion), who I would assume is the main supplier of pulmonary valve homografts in the world. Artivion is also behind the 1.5-2.0 INR and PROACT trial for the On-X valve, which in my opinion is pure marketing that has no real world benefit, and is misleading and harmful to patients.

 

[Superman]

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.


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.

My only real complaint about a lot of this research is that 19 months is not long term. That’s a blink of an eye. This comes from the perspective of being nearly 34 years in. 19 months ago we were already post pandemic. But that stuff feels like yesterday.

I know it’s not possible for a new procedure to have a truly long term study. And I know most patients don’t get their valves during their teenage years. But 19 months? Get back to me in 20 years and let me know how it’s going.

 

[j42195]

@Deidra, good points to consider, indeed.
And agree that that Ross website seems shady, as does the marketing gimmick with On-X, of course.

I know it’s not possible for a new procedure to have a truly long term study. And I know most patients don’t get their valves during their teenage years. But 19 months? Get back to me in 20 years and let me know how it’s going.

They have to start somewhere, of course. But I can only agree that it's not very comforting to read 19-months-long studies
There are some longer-term studies on Ozaki as well, though:
https://www.medrxiv.org/content/10.1101/2023.05.08.23289697v1 (up to 14 years)
https://tgkdc.dergisi.org/abstract.php?id=3303 (up to 12 years)

But yes, I think we all agree that it's not as well researched/established as some of the other procedures.

 

[V__]

If the root/annulus is not properly stabilized (probably not possible in all cases) ..., I would be extra suspicious about long term durability, personally.

I think it's a very good point. I wonder how often the ring annuloplasty is used with Ozaki or "just" AV repair.

I know for MV repair the ring insertion is a standard part of the surgery. It improved the long-term durability significantly.

 

[Juli]

@Deidra, good points to consider, indeed.
And agree that that Ross website seems shady, as does the marketing gimmick with On-X, of course.



They have to start somewhere, of course. But I can only agree that it's not very comforting to read 19-months-long studies
There are some longer-term studies on Ozaki as well, though:
https://www.medrxiv.org/content/10.1101/2023.05.08.23289697v1 (up to 14 years)
https://tgkdc.dergisi.org/abstract.php?id=3303 (up to 12 years)

But yes, I think we all agree that it's not as well researched/established as some of the other procedures.

Thank you - great material and a great discussion. I agree that Ozaki looks promising and could develop into a mainstream procedure in maybe 5 to 10 years.

I can live with my mechanical valve but the apparently better performance of the Ozaki valve makes me envious.

 

[pellicle]

I agree that Ozaki looks promising and could develop into a mainstream procedure in maybe 5 to 10 years.

after reading what lucker sent me, I can't say I agree that it looks promising. As I see it something made in a quality controlled process way (such as a bio valve) where testing occurs and processes are honed accordingly will have advantages. Perhaps this 'hand stitched and cut process' (much more cottage industry except done in an operating theater) proves better does not ring true. At the very least it requires the person who's making that to be highly skilled on making that.

I'm someone who makes things with my hands all the time (a trivial for instance) and I still make occasional small mistakes. The article also noted its use in places which seemed like cost was a major issue. Given that a bioprosthesis costs thousands of dollars

I think something else is driving that appeal in a place where the surgeon wouldn't get paid what middle salary worker would in the USA
I remain a data / evidence driven guy ... I just don't see it.


¯\_(ツ)_/¯

I wouldn't put my life on that hope unless it was the last hope because we just don't have the data to say how durable it is or what the complication rates are or what its like when you try to scale that up to retrain (how many thousands of) surgeons in the USA (not to mention all of the EU.

It remains to me the sort of "dark horse hope" that I think (being brutally honest here) only the ignorant and the anxious would turn to ...

 

[pellicle]

For all decision makers let me remind you :

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6706839/#:~:text=For the treatment,).

For the treatment of aortic valve diseases, biological prosthetic valves are available, in addition to mechanical prostheses and reconstructive methods. The crucial advantage of using biological valves—compared with valve replacements using mechanical prostheses—is the fact that continuous anticoagulation is not required. Another advantage for many patients is also the fact that biological valves do not produce any sounds. The disadvantages of biological heart valves are a smaller valve orifice area (3) and the risk of structural valve degeneration (4), which may necessitate reoperation (table 1).​

my bold ... and I bolded it because they think its crucial. There is an assumption that managing anticoagulation therapy (ACT) is onerous and difficult. That idea vanished with two things at least 10 years ago (probably 20)

• well priced point of care machines
• patient self testing / patient self management

I personally self manage and I've taught people in the following countries how to (who wanted to)

• USA
• Canada
• Singapore
• Thailand
• Slovakia
• Romania
• UK
• Australia

its so easy even I can do it.

Further this is not just "my opinion" its in the literature and discussed here by Dr Schaff of the Mayo


a more current video


So if you are actually trying to inform your decision (not research to support your decision) then I recommend that

I'd also recommend this:


Don't let anxiety instead of desire steer you (which it will)

Best Wishes

 

[Deidra]

my bold ... and I bolded it because they think its crucial. There is an assumption that managing anticoagulation therapy (ACT) is onerous and difficult. That idea vanished with two things at least 10 years ago (probably 20)

• well priced point of care machines
• patient self testing / patient self management

As someone who had a mechanical valve installed a month and a half ago, I can say that so far the warfarin has been a piece of cake, even though I am going to a clinic right now because the US requires that for a few months. It's just a half hour or so out of my week. With self-testing it would be much much less than that. Other than that, it's just another pill to take. I did also get my own meter and test strips just to have a backup, and even that was easy, although expensive.

Compared to what diabetics have to go through in terms of testing, it seems like a walk in the park. I would much rather have to deal with this, compared to the near-guaranteed or high likelihood re-ops involved in the other options (for someone who is 28). My surgeon and I talked it over and like he said, with a 28 year old we have to be thinking 40-50 years out into the future. The only thing that is designed and expected to consistently last that long is a mechanical valve.

 

[pellicle]

Compared to what diabetics have to go through in terms of testing, it seems like a walk in the park. I would much rather have to deal with this,

that's a comparison I often make.

I have a friend who's a bit older than me, he's been diabetic for a few years now and "doesn't want to waste his time testing so much". So he tests once or twice a day and just injects an amount of insulin "that'll do" and moves on.

He still drinks some alcohol (not like he used to) is suffering loss of feeling in the extremities and (to me) is undergoing observable cognitive decline.

¯\_(ツ)_/¯ IDK

How many deaths are associated with diabetes in Australia?

• Diabetes contributed to around 19,300 deaths in 2021 (11.2% of all deaths) and was among the 10 leading causes of death in Australia.
• Males were 1.7 times as likely to die from diabetes as females.
• Age-standardised mortality rates for diabetes (underlying and/or associated cause) increased by 3.7% between 2020 and 2021.
• There were 833 deaths associated with diabetes among Aboriginal and Torres Strait Islander people in 2021.

 

[Deidra]

that's a comparison I often make.

I have a friend who's a bit older than me, he's been diabetic for a few years now and "doesn't want to waste his time testing so much". So he tests once or twice a day and just injects an amount of insulin "that'll do" and moves on.

He still drinks some alcohol (not like he used to) is suffering loss of feeling in the extremities and (to me) is undergoing observable cognitive decline.

¯\_(ツ)_/¯ IDK

How many deaths are associated with diabetes in Australia?

• Diabetes contributed to around 19,300 deaths in 2021 (11.2% of all deaths) and was among the 10 leading causes of death in Australia.
• Males were 1.7 times as likely to die from diabetes as females.
• Age-standardised mortality rates for diabetes (underlying and/or associated cause) increased by 3.7% between 2020 and 2021.
• There were 833 deaths associated with diabetes among Aboriginal and Torres Strait Islander people in 2021.

Makes you wonder how many of those deaths could have been prevented or at least delayed if patients were better at compliance and self-management.

 

[pellicle]

Makes you wonder how many of those deaths could have been prevented or at least delayed if patients were better at compliance and self-management.

exactly (and I do wonder that; out loud here on occasion WRT ACT)

In Diabetes world Continuous Glucose Monitoring has been around for a while now. Because I was a Software Developer for some years I encountered a few people who were early hackers employing open source software

Eg http://www.nightscout.info/

https://en.wikipedia.org/wiki/Continuous_glucose_monitor

We seldom need such frequency of testing; although there are occasions I monitor daily (or more) to learn about my own reactions and turn arounds. Its not just me, sometimes others test more than me (and get more interesting data

https://cjeastwd.blogspot.com/2022/05/rapid-dust-off-inr-management.html

Data data data...

 

[tom in MO]

"It remains to me the sort of "dark horse hope" that I think (being brutally honest here) only the ignorant and the anxious would turn to ..."

I don't know why you are calling proponents of different paths ignorant, or inventing scenarios such as:

I think something else is driving that appeal in a place where the surgeon wouldn't get paid what middle salary worker would in the USA
I remain a data / evidence driven guy ... I just don't see it.

It's hard to see you as a "data / evidence driven guy" when you trot out a 15yo Mayo clinic video that's been pulled by Mayo but kept alive by you.

 

[Deidra]

It's hard to see you as a "data / evidence driven guy" when you trot out a 15yo Mayo clinic video that's been pulled by Mayo but kept alive by you.

There's a video from 2y ago linked right below it that goes over very similar info lol

 

[tommyboy14]

@j42195

Hello,

Let me give my two cents. At the time of my first surgery I researched the Ross in Europe extensively. Europe has some of the best Ross surgeons in the world.

But in your case if you only have regurgitation, then perhaps you should consider a Valve repair. Germany's top valve repair guy, Professor Hans-Joachim Schaefers retired last year and is now operating in Spain (In Germany you need to require at 65 although many surgeons would like to keep going). Why not look him up in Spain?

The other very good valve repair person is Professor Gebrine El-Khoury in Belgium.

If you are certain that you want a Ross, the doctor which has a very good track record and still operating now, is Professor Vladimir Voth at the Sana Hospital in Germany. Professor Hans Sievers used to be the best when I looked for Ross surgeons, but his Ross technique was not applicable to dilated roots and he is retired now.

Now one thing you need to know about the Ross is that, unlike after regular valve reoperation, the outcomes arent very good for reoperations even if performed in teh hands of a world class surgeons. Please see below.

At your age you will be guaranteed at least one other OHS if you go Ross.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8339619/

https://www.annalsthoracicsurgery.org/article/S0003-4975(22)00729-9/fulltext

The outcomes of these Ross reoperations are not good, even in the hands of Doctor Paul Stelzer, who is advertised as one of the top Ross surgeons in the US. And when I say not good, I mean not good relative to regular aortic valve reoperations, where your life expectancy is broadly normal, assume you survive the reoperation.

Some surgeons have good outcomes
https://www.sciencedirect.com/science/article/abs/pii/S0022522322005013

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10162808/

But here is the one million USD question: How will you know in real time which surgeon has good ross procedure reoperations outcomes, when the time of the reoperation comes?

Because this is such an unusual operation you really cant know...

 

[tommyboy14]

@j42195

Also another interesting meta-analysis is here: https://pubmed.ncbi.nlm.nih.gov/30562065/
they say:

Estimated life expectancy after surgery was 59 years for children (general population: 64 years) and 30 years for a 45 years old (general population: 31 years).

But they also say:

Lifetime risks of autograft and right ventricular outflow tract reintervention were, respectively, 94% and 100% for children and 49% and 19% for a 45-year-old.

So there is a 68% chance of a reop after Ross in your age group.

 

[pellicle]

I know that its only two members, but I'm going to say this isn't something you'll find among the bioprosthetic members ... at all

https://www.valvereplacement.org/threads/new-member.889635/post-934305

I had my stenotic aortic valve replaced wirh a St. Jude valve in 1977. Have to take warfarin daily and have blood tested for coagulation rate every week or so, but other than that life is normal. Surgery was uneventful.

So that's more than 46 years. Like I say again, and again and again, and its in the Surgical Guidelines everwhere if you're under 60 its mechanical for the best chance to win.

Its why all mech valvers here give up posing their 'valvaversary' after the first couple of years and why bio valvers make a big deal about getting to 19 or 20 ... and it is a big deal because the statistics are more like 10 good years and maybe 15 before replaement.

So if you look at your age and combine it with the statistical average age of death for your nation; and its a life expetancy of over 30 years then you will only get that reliably with a mech valve. The literature is repeat with non-specific fear mongering of:

• life long anticoagulation
• the burden of INR testing

strangely don't mention the documented incompetency's of INR clinics and the bewildering "dipshttedness" of people who just don't want to comply and make zero effort. Perhaps this group are so large that surgeons are sick and tired of seeing their good work (which should last >30 years) ruined because some dope wouldn't take their pill or manage their INR or even get involved with managing their health.

Everyone with "the usual dilemma" needs to see and understand these simple well established facts. However looking at the obesity epidemic I can perhaps see evidence that a majority of the population can't manage their own health.

Know your self honesty and make your choice. Its my view that anxiety is a reflection of that you aren't listening to yourself some how

a worthy watch


Best Wishes to all with 'choice dilemma'

 

[pellicle]

for reference:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10449611/

"Our case report focuses on a 76-year-old patient who had undergone an AVR with a bioprosthetic valve at the age of 33, which has still not demonstrated any valve deterioration. As the longest known case of bioprosthetic durability, this patient provides useful data for designing bioprosthetic valves more resistant to structural degeneration and thereby better suited to younger patients or those at higher risk of bleeding."​

So this is 43 years, its so exceptional that they wrote a journal article about it. Its well known that you just don't get that on average

Roulette bet type	Example roulette bet	Potential payout	European roulette odds	American roulette odds
Column	Any number in the third column	2:1	32.40%	31.6%
Dozen	Any of 13 to 24	2:1	32.40%	31.6%
Even bets	Black over red	1:1	48.60%	47.4%
Single number	7	35:1	2.70%	2.60%
Two numbers	Either 19 or 20	17:1	5.4%	5.3%
Three numbers	Any of 28, 29 or 30	11:1	8.1%	7.9%
Four numbers	Any of 5, 6, 8 or 9	8:1	10.8%	10.5%
Five numbers	Any of 0, 00, 1, 2, or 3	6:1	13.5%	13.2%
Six numbers	Any of 4 to 9	5:1	16.2%	15.8%

Single number choice in Roulette is still better than the odds of getting 43 years, and you only get one pick here (or you're facing reops).

The medical profession accepted average durability is found here.

Tissue valve​

Tissue valves are created from animal donors’ valves or animal tissue that's strong and flexible. Tissue valves can last 10 to 20 years and usually don't require the long-term use of medication. For a young person with a tissue valve replacement, the need for additional surgery or another valve replacement later in life is highly likely.​

I've underlined points within that summary

With respect to The Ross you can find studies which say up to 25 years, but equally you can find evidence here of what happens on redo (and less than 25 years).

Don't pick based on desire, pick based on data.

Best Wishes