Durability of RESILIA-tissue valve vs other tissue valves

[gpr100rs]

For those who have (me) or are considering the RESILIA-tissue valve, a recent study compared the structural hemodynamic valve deterioration of RESILIA tissue valves to that of non-RESILIA contemporary valves from a separate randomized controlled trial. The authors reviewed data from the on-going COMMENCE study and compared 689 patients with RESILIA tissue valves with 936 patients with valves with other, contemporary tissue valves. Over 5 years following valve implantation, "the RESILIA-tissue valves exhibited significantly reduced levels of structural hemodynamic valve deterioration compared with the contemporary valves." The authors acknowledged "meaningful limitations" of the study and "longer-term investigation is necessary," but the data to date is promising that the Resilia valve will have good long term function and better durability compared to other tissue valves. I was 63 when I was implanted with the Resilia valve 3 yrs ago with the hope it would last at least 15 yrs at which point I could do a TAVR which should get me to the finish line. The article can be found here: https://becarispublishing.com/doi/10.2217/cer-2022-0180

 

[pellicle]

Hi

firstly I want to say that I agree with you, its encouraging, then I want to follow that up that the spirit of this reply is for any lurkers and those still "in the waiting room". It is not intended to be attempting to be a rebuttal of your points.

Over 5 years following valve implantation, "the RESILIA-tissue valves exhibited significantly reduced levels of structural hemodynamic valve deterioration compared with the contemporary valves." The authors acknowledged "meaningful limitations" of the study and "longer-term investigation is necessary,

this sort of duration and freedom from SVD goes back to porcine valves in the 1970's

https://pmc.ncbi.nlm.nih.gov/articles/PMC1767707/

The Edinburgh heart valve study of 533 patients, who had their valve implant(s) between 1975 and 1979, now reports comparative clinical outcome for mechanical versus bioprosthetic valves at 20 years.1 The present report supplements a 12 year follow up, published in 1991.2 The original study was prospective and randomised. The study design was modified in January 1977 in those patients randomised to receive a porcine bioprosthesis. Initially, the porcine valve used was the Hancock prosthesis, but, after January 1977, the Carpentier-Edwards valve was used because of its “substantial cost advantage”.​

So, yes, I agree that to making meaningful determinations will take much longer than 5 years.

For example we know that in statistics there are averages and standard deviations and of course outliers too

So somebody exists on that 4 standard deviations point (at both ends). That'd be this guy

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

I think that its tempting to believe "huge strides" have been made in bioprosthetic valves; however the data shows "subtle but encouraging improvement" more around the "diversity" of the range than the maximum durability.


https://www.jtcvs.org/article/S0022-5223(19)38753-7/pdf

I thought I'd note some interesting points in that

Patient survival rates, with operative mortality excluded, were 80% ±1.7%​

(standard error) at 5 years and 68% ± 2.7% at 10 years. Survival rates for​

patients with aortic valve prostheses were 78% ± 2.8% at 5 years and 57% ± 5.4% at 10 years; for patients with mitral valve prostheses, survival rates were 80% ±2.2% at 5 years and 69% ±3.2% at 10 years. Freedom from thromboembolism for aortic valves was 93% ± 1.4% at 5 years and 88% ± 2.6% at 10 years; for mitral valves the freedom from thromboembolism was 89% ± 1.5% at 5 years and 84% ± 2.2% at 10 years. Freedom from degeneration or primary tissue failure for aortic valves was 97% ± 1.3% at 5 years and71% ± 7.6% at 10 years; for mitral valves these figures were 96% ± 1.2% at 5 years and 71% ± 4.1% at 10 years.​

​

Valves in patients 35 years of age and below had a significantly greater rate of​

degeneration (p < 0.001).​

After 12 years' experience the porcine bioprosthetic valve has performed well with regard to patient survival and low rate of thromboembolism. For patients older than 35 years the freedom from primary tissue failure is 80% at 10 years.

​

As a casual reader (not just the person to whom I'm replying) this remains pretty close to present observations.

For instance we have this thread:
https://www.valvereplacement.org/threads/different-strokes.889520/#post-931857
where the poster had:

Aortic valve replaced 7 August 2019, aged 61, with a 23mm Edwards Inspiris Resilia aortic valve via mini sternotomy at St Thomas’ Hospital, London.​

Whats despite the projections of others upon me I am not a 'hater', I myself have written here on numerous occasions that the Resilia is a good choice within bioprosthetics.

well firstly the resilia isn't a bad choice and you could (depending on activity) get 20 years from it.

So I want to second your vote for your choice of a resilia

but equally I am well known for the view that a mechanical valve and well handled anticoagulation (INR) is the best chance you have for an event free post surgical life.

Usually those who are firmly "tribal" about this push back or outright (ongoingly) attack me for my data driven stance.

Best Wishes

 

[gpr100rs]

There should be zero dispute that a mechanical valve is a "one and done" whereas a biologic valve will gradually fail. The issue for the industry is slowing the SVD in the biologic, but there is likely little prospect, short of cloning, of ever matching the "durability" of a native valve. My defective, bicuspid valve lasted 63 yrs. Only time will tell if Edwards is on to something with the way it processes its Resilia leaflets. In Edwards' words the leaflets feature "anti-calcification technology." We'll see....

 

[pellicle]

Good morning

There should be zero dispute that a mechanical valve is a "one and done" whereas a biologic valve will gradually fail.

agreed

The issue for the industry is slowing the SVD in the biologic,

agreed

but there is likely little prospect, short of cloning, of ever matching the "durability" of a native valve.

even then the "Ross" suggests that durability is similar, as well as not only my experience with my living tissue Homograft but the studies done by that center ....

My defective, bicuspid valve lasted 63 yrs.

that's an excellent run ...

Only time will tell if Edwards is on to something with the way it processes its Resilia leaflets. In Edwards' words the leaflets feature "anti-calcification technology."

I'm highly suspicious of this sort of 'marketing claim' and to me this stuff should be kept only to the surgeon and cardiologists (not disseminated to the public). I was feeling some level of confidence in this earlier but the issue with a couple of them have shown that probably "they are just like any other" and there is no improvement in them. For instance from
https://www.edwards.com/healthcare-professionals/products-services/surgical-heart/aortic-pericardial

we see

"... to deliver the potential for ..."

yet:
https://pubmed.ncbi.nlm.nih.gov/36172410/

which is mostly fluff for (in my opinion an increasingly "general public" audience)

... Patients were prospectively followed (mean 6.6 ± 2.6 years) with clinical evaluation and yearly echocardiography. Follow-up was 98% complete (7 patients lost) for a total of 2238 valve-years. Bioprosthesis structural valve deterioration was determined by strict echocardiographic assessment based on the Valve Academic Research Consortium 3 criteria.​

what's fluff in that is:

• making it sound big and grand but with followup of between 4 years and 9.2 years, when the literature is pretty clear that you only see SVD after 8 years.
• two thousand two hundred and thirty eight years ... wow ... if I followed 3800 patients for a year would that show more or less of what emerges only after 8?

almost nothing in my literature search this morning returned much that didn't say stuff like:

Another bench study has also shown excellent long-term durability of the Magna Ease bioprosthesis to 1 billion cycles with an EOA of 1.81 ± 0.06​

Its very well known by them that machine testing on a bench does not reflect in your body testing. However that figure is something like 20 years of "average operation" in terms of actuations. So at least that's a good thing.

We'll see....

indeed. But the choice you made is still a good one. I'm just addressing us being inadvertently becoming shills for a product because of our emotional investment.


Best Wishes

 

[pellicle]

@gpr100rs

But the choice you made is still a good one

a recent study which has some data that backs up my view above

https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2789686

To assist the reading:

Valve model groups were classified as follows: Perimount (Perimount 2900, Perimount Magna, and Perimount Magna Ease),​

sadly (for your interest):

A few valves (eg, Inspiris Resilia) were excluded from further analysis because of the small number of valves.​

However I suspect that there should be good concordance between the Magna and the Resilia

Some graphs of interest
an important note is below these diagrams which helps in understanding them

Figure 1. Regression-Standardized Cumulative Incidence of Reintervention, With Death as the Competing Risk

perimount is lowest risk

Figure 2. Regression-Standardized Survival

perimount is highest survival

Figure 3. Regression-Standardized Cumulative Incidence of Heart Failure Hospitalization, With Death as the Competing Risk

perimount is lowest risk

NOTE as mentioned:

The curves represent the expected outcome if the entire population received each valve model. For example, if the entire population received a Perimount valve, 12.9% of them are expected to be hospitalized for heart failure in 10 years.​

So this is why I have the view that (based on the data I've read) perimount valves are good.

The whole article is well worth a read.

I know I'm seen here (by people who can't read) as being pro mech and by corollary anti tissue; but this is not the case. I do indeed do quite some reading in that arena because I like to be more broadly informed (and help others)

Best Wishes