Joint Statement on Aortic Valve Replacement in Low-Risk Patients Issued by Society of Thoracic Surgeons and European Association for Cardiothoracic Su

[ATHENS1964]

https://www.dicardiology.com/conten...isk-patients-issued-society-thoracic-surgeons

 

[pellicle]

Very interesting

 

[pellicle]

some interesting wording from the study that was cited within the above joint statement

https://www.annalsthoracicsurgery.org/article/S0003-4975(23)01064-0/fulltext
bold mine

RESULTS​

The mean age was 74.3±5.7 years and mean STS PROM was 1.9%±0.8%. The overall Kaplan-Meier time to event analysis for all-cause mortality at 1-, 3-, 5-, and 8-years was 2.6%, 4.5%, 7.1% and 12.4%, respectively. In subset analyses, survival was significantly better for 1) lower STS PROM (p<0.001), 2) younger versus older age (p<0.001), and 3) higher versus lower LVEF (p<0.001). When STS PROM was below 1% or the patient age was below age 75 years, the 8-year survival following SAVR was 95%.​

CONCLUSIONS​

The results of this national study confirm that the long-term survival following SAVR remains excellent, at 92.9% at 5 years. These contemporary longitudinal data serve to aid in the balanced interpretation of current and future trials comparing SAVR and TAVR and may assist in the clinical decision-making process for patients of lower surgical risk.​

​

leaves me again asking what is younger when the mean age was 75 and so -5.7 years isn't what I call young; I'm nearly 10 years younger than their youngest and I'm not calling myself young.​

but still, very interesting stuff

 

[skeptic49]

Young is a state of mind, I guess. Interesting stuff.

 

[DrCooper]

leaves me again asking what is younger when the mean age was 75 and so -5.7 years isn't what I call young; I'm nearly 10 years younger than their youngest and I'm not calling myself young.​

That's probably big numbers illusion (the study database has 42000 patients).

5.7 is one standard deviation. I round it to 6 in my example below.
Assuming normal distribution (which is very likely not the case):

• ~34%: 69-75
• ~34%: 75-81
• ~14%: 63-69
• ~14%: 81-87
• ~2.5%: 57-63
• ~2.5%: 87-93

Most likely, data are skewed somehow towards the lower values with sporadic values / outliers in the young adult ages (20-50).

Population means and standard deviations are such poor metrics... I wish we had access to the actual raw data from all these studies rather than aggregated massaged statistics.

But in any case it's crystal clear we are in a disease of elderly patients

 

[LondonAndy]

Agreed, an interesting article. Looking forward to the follow-ups at 10 and 15 years after the procedures .....

 

[pellicle]

But in any case it's crystal clear we are in a disease of elderly patients

agreed.

However, I had my first OHS at 10yo, I had my second at 28 and my 3rd at 48; I'll be 60 next year. Given that #3 was a mechanical and a bental to fix an aneurysm I'm anticipating I won't need #4. So I have a different premise about age groups and statistics.

Oh, and I just had a CT with contrast as part of the follow up process (previous one was about 5 years ago). We'll see but I'm expecting "no news".

Best Wishes

 

[Superman]

I’m still well outside the range and I’m coming up on 33 years of ticking. It’s weird learning what an outlier I remain even after meeting this community.

 

[pellicle]

It’s weird learning what an outlier I remain even after meeting this community.

from so many angles ;-)
#metoo

 

[Protimenow]

What would they have called a 'younger' patient 60 years ago? This just shows how much life expectancy has changed over time.

(Without my aortic valve, I would have probably died in my early 50s. Without penicillin in the '30s, life expectancy was much lower. Over the last century -- and maybe even 50 or 60 years, the idea of 'younger' has extended far higher than anyone from the 19th and early 20th centuries could have even imagined).

Now that I have finally become a 'younger patient,' I'd still like to continue working (with my mind, not too much physical - I'm a writer and editor, anyway) and making my own money, boosting my self value, and demonstrating to myself and others that even young people can be valuable and should be allowed to contribute when they can. (Supplementing Social Security income would be an added, much need, bonus).

 

[carolinemc]

That's probably big numbers illusion (the study database has 42000 patients).

5.7 is one standard deviation. I round it to 6 in my example below.
Assuming normal distribution (which is very likely not the case):

• ~34%: 69-75
• ~34%: 75-81
• ~14%: 63-69
• ~14%: 81-87
• ~2.5%: 57-63
• ~2.5%: 87-93

Most likely, data are skewed somehow towards the lower values with sporadic values / outliers in the young adult ages (20-50).

Population means and standard deviations are such poor metrics... I wish we had access to the actual raw data from all these studies rather than aggregated massaged statistics.

But in any case it's crystal clear we are in a disease of elderly patients

Heart disease and heart defects is at all ages. I was born with my heart defect, heart murmur and the Birth defect of the aortic valve. Not from old age.

 

[Gkeraney]

some interesting wording from the study that was cited within the above joint statement

https://www.annalsthoracicsurgery.org/article/S0003-4975(23)01064-0/fulltext
bold mine

RESULTS​

The mean age was 74.3±5.7 years and mean STS PROM was 1.9%±0.8%. The overall Kaplan-Meier time to event analysis for all-cause mortality at 1-, 3-, 5-, and 8-years was 2.6%, 4.5%, 7.1% and 12.4%, respectively. In subset analyses, survival was significantly better for 1) lower STS PROM (p<0.001), 2) younger versus older age (p<0.001), and 3) higher versus lower LVEF (p<0.001). When STS PROM was below 1% or the patient age was below age 75 years, the 8-year survival following SAVR was 95%.​

CONCLUSIONS​

The results of this national study confirm that the long-term survival following SAVR remains excellent, at 92.9% at 5 years. These contemporary longitudinal data serve to aid in the balanced interpretation of current and future trials comparing SAVR and TAVR and may assist in the clinical decision-making process for patients of lower surgical risk.​

​

leaves me again asking what is younger when the mean age was 75 and so -5.7 years isn't what I call young; I'm nearly 10 years younger than their youngest and I'm not calling myself young.​

View attachment 889653

but still, very interesting stuff

Sure, if you didn't already know this I would be stunned. We got here because urban surgeons in busy medical centers are very confident doing open heart surgery on patients up to 75 and a little past that who are healthy for their age. Indeed, they are confident doing a third open heart at that age but they want that one to be the last one. What is happening now is the tavi docs, interventional cardiologists usually, are in a turf war with surgeons.

The 5 year tavi data is excellent in comparison to the surgical valves. But in savr valves, the ten year data is good also, and we don't know that about tavi in low risk folks. We ALMOST know that tavi in moderate risk is the same as savr at ten years, and it looks like we will know exactly that in about 2 more years. But we won't know in low risk for 5 more years. Many tissue valves looked good at 5 years and started to break after 7. They need 10 year data. The surgeons statement was too complicated, imho. They just should have said we think there is nothing in this data to undermine current standards which is get a savr up to 75 in most cases. The USA standard is 65 but these are the Euro guys writing. Bottom line, we know that folks who get a tavi that are young and healthy are ok for 5 years. We don't know if its a bad mistake by ten years, or a good decision.

 

[Chuck C]

Thanks for this link Athens.

I really appreciate this commentary by Society of Thoracic Surgeons (STS) and European Association for Cardiothoracic Surgeons (EACTS). In my view, it is a very good analysis, and message of caution, about the recent results published by PARTNER 3 and Evolut Low Risk trials, comparing TAVI to SAVR for low risk patients.

In my view, here are some key points from the commentary on these studies.

PARTNER 3 concluded thsat TAVI was about the same risk as SAVR for low risk patients at 5 years. In medical jargon, the way they say this is that TAVI is noninferior.

Evolut found that, after 4 years, TAVI outcomes were superior for low risk patients, when compared to SAVR.

The commentary points out that these are industry sponsored trials and took some issues with how the data was presented:

From the commentary: "Given the highly selected cohorts of these carefully adjudicated industry sponsored trials, we feel that some of the statements made were appropriately weighted with equipoise, but some were not."

Many, if not most, trials of this nature are industry sponsored. While, of course, this does not mean that we toss out the data, because there are large financial stakes at play, it means that there should be close critical analysis applied to these publications. Well, this is true of any study, that such critical analysis should be applied, regardless of the funding, but it is good to be aware that the strong potential for bias exists in these types of trials, given the financial stake of the funders.

The message from the STS and EACTS, basically, is to express caution and let's not be so quick to start referring all low risk patients for TAVI just yet.
They make an important point below, and call for more data to be published from these trials:

"With 26% of SAVR cases in this Trial undergoing concomitant operations (e.g., CABG, MV surgery, surgical ablation, and others), we feel this may hold possible significant interpretive explanation for these data."

Importantly, they add: "Therefore, statements of superiority of TAVI compared to a heterogeneous surgical comparator, are not appropriate at this time and may lead to unintended consequences."

They add further:

"Furthermore, in order for all valve therapy specialists, including general cardiologists, interventional cardiologists, and surgeons, to compare low-risk TAVI all-cause mortality outcomes to the STS benchmark for isolated SAVR, we call on investigators from both the PARTNER 3 and Evolut Low-Risk trials to publish their results for the isolated SAVR and isolated TAVI sub-cohorts from their trial arms."

This seems incredibly obvious. Complex surgeries, involving other procedures, such as CABG, are going to have higher mortaility. If one truly wants a apples vs apples comparison, why would these 26% be included in these trials? STS and EACTS are spot on to call for the subset of data to be published to properly compare low risk SAVR vs low risk TAVI.

I think this is a good example of how data can be manipulated. I'm not claiming that it was, but it does beg the question as to why those 26% were included in the SAVR groups, if there is to be any meaningful comparison between SAVR and TAVI.

"Until we have this data, any statements or conclusions from these trials are interesting but still hypothesis generating and speculative. STS and EACTS therefore recommend caution prior to adopting a TAVI-first strategy in low-risk patients, particularly those patients with characteristics not specifically studied in these low-risk trials."

Exactly! Well done.

 

[Chuck C]

They just should have said we think there is nothing in this data to undermine current standards which is get a savr up to 75 in most cases. The USA standard is 65 but these are the Euro guys writing.

I wish that the US guidelines were as cautious as the EU guidelines. As you point out, in EU, the guidelines state that TAVI should be considered in those 75+ and in the US, it is to be considered in those 65+. I agree with the commentary, that there is not sufficient data to push for TAVI first in low risk patients yet. Perhaps we should also consider how much the industry lobby influences changes in the US guidelines.

 

[Protimenow]

Heart disease and heart defects is at all ages. I was born with my heart defect, heart murmur and the Birth defect of the aortic valve. Not from old age.

Mine was congenital, and I suspect that many of us here also have had congenital heart issues. I was born with a bicuspid aortic valve.

These defects are commonly undiagnosed and undetected. I was 23 when mine was heard as a murmur by a med student. (I had been suffering with symptoms of it, probably all my life, but it all seemed normal to me because I really had no 'normal' to compare it to -- in P.E., I was the slowest, not being able to keep up with the others (because my heart was working harder than others), I overheard a coach once tell a student that I 'had no guts', not knowing that I couldn't wrestle because I couldn't wrestle -- ironically, I heart that this coach died of a heart attack while running a lap during one of his classes. Maybe HE had an undiagnosed heart issue (maybe his 'heart attack' was aortic dissection or another cardiac issue.

 

[Protimenow]

I wish that the US guidelines were as cautious as the EU guidelines. As you point out, in EU, the guidelines state that TAVI should be considered in those 75+ and in the US, it is to be considered in those 65+. I agree with the commentary, that there is not sufficient data to push for TAVI first in low risk patients yet. Perhaps we should also consider how much the industry lobby influences changes in the US guidelines.

FWIW - they're now running commercials for TAVR on local (and probably national across the U.S.) television. I don't know if I've seen these ads on over the air channels.

The commercials target seniors, but don't indicate ages.

 

[pellicle]

Heart disease and heart defects is at all ages.

How old were you at your first OHS?

I was born with my heart defect, heart murmur and the Birth defect of the aortic valve. Not from old age.

the point is that for the average person these defects (which are congenital) manifest later in life. If they manifested too early in life then the gene would leave the genepool because people would die before having and raising kids.

I believe that the statistics demonstrate this.

 

[DrCooper]

I have to retract my comment above as the clinical trial seems to have some interesting exclusion criteria eg Aortic valve is unicuspid, bicuspid, or non-calcified


https://clinicaltrials.gov/study/NCT02675114
That means that they excluded patients with congenital aortic valve disease (among many other things) and focused on the tricuspid elderly population.

 

[Gkeraney]

I wish that the US guidelines were as cautious as the EU guidelines. As you point out, in EU, the guidelines state that TAVI should be considered in those 75+ and in the US, it is to be considered in those 65+. I agree with the commentary, that there is not sufficient data to push for TAVI first in low risk patients yet. Perhaps we should also consider how much the industry lobby influences changes in the US guidelines.

Medtronic and Edwards have made some excellent tavi valves. It's also probable that most folks can get a second one inside the first one. Already, this hypothetically looks like savr 12 years, tavi 10 years, tavi 10 years. So one open heart, no anti coagulation in theory, and you get 30+ years. But then you need a surgery that is very high risk for now.

I would bet that what the future holds for the low risk folks is a savr at age 30, which lasts 15 years, and then two tavis which get you to 70, then its done all over again. The problem right now is doing the surgery after tavi is high risk. Not enough of these procedures have been done. At some point, the risk on those will plunge to 3% or lower and then the guidelines could change.

Another thing that would make sense far into the future would be something like a valve with synthetic tissue that really lasts but you have to do warfarin. What I mean is a tavr so you never have open heart. You do two tavr's and you get 30 years out of each one. You might even get three. (they use a balloon to fracture the valve ring so the new valve is almost the same size.) You need warfarin though and the public is unaware its not that hard to do. I think this will happen, thus the howling from the thoracic surgeons who feel they have perfected a safe procedure which is pretty close to the full truth.

 

[pellicle]

I have to retract my comment above as the clinical trial seems to have some interesting exclusion criteria eg Aortic valve is unicuspid, bicuspid, or non-calcified

personally I think that while the primary purpose of this place support, discussion and learning is also of significance.

So unless its our professional domain the only time we get to work through what we are learning is by discussing it here with peers.

What I'm saying is posting something, discussing it, then changing your mind isn't something you should be ashamed of. Indeed the opposite is true, it shows character.

Best Wishes