When Edwards' INSPIRIS RESILIA Valve will be market available in US?

[hx77]

This is my first post. I am a male, 53 years old, 135 lb, non drinker/smoker, BP 110/70, no diabetes and my cholesterol level is normal. I was diagnosed of BAV with modest aortic stenosis 3.25 years ago. Because of feeling chest/throat pressured after even minor exercise, I did an angiogram a week ago. I was told I need a bypass immediately as two of my my coronary arteries were blocked (100% and 70% blocked respectively). My doctors also recommended me to replace my AV at the same time.

I have spent a lot of time reading posts on VR.org (thanks everyone for sharing your experience!) and i even ventured to read some medical research papers on factors driving deterioration in TV. I initially favored MV especially after reading On-X here. But later i realized On-X does not totally get rid of ACT and it just represents an incremental improvement over current MV. Knowing that it's easy for me to get cuts in the hands (I cook/DIY at home) and the prospect of having other surgeries to treat other organs is high for me, I started leaning towards TV. However some research showed TV deteriorates faster in "young" patients. For example, one paper found at 10 years post AVR, the need of a re-plantation is 17% in 65 group vs 5% in 75 group (I do not have the reference to that paper now so i might be wrong). I am surprised at this data as very few 75 years old people with heart problems will live past 85.

Anyway using a TV that calcifies less is important to me as I only want to do OHS once. The Edwards' INSPIRIS has demonstrated good anti-calcification features in animal test (http://www.jtcvsonline.org/article/S0022-5223(14)01337-3/pdf). The attached picture, self explaining, is the highlight of the paper. FDA approved INSPIRIS valves in July 2017. But my surgeon told me it's not market available in US yet. The first commercial implantation of INSPIRIS was performed in London in early June 2017, more than 8 months after it was approved in Europe in Sept 2016 (https://cardiovascularnews.com/firs...ces-inspiris-resilia-aortic-valve-take-place/) Why it took so long? Anyone knows when it will become market available in US?

If I choose a TV, i likely will do another AVR with TAVR. My aortic size is 23 according to my surgeon and he said i could have at least one satisfactory TAVR down the road. INSPIRIS line of valves are designed with valve-in-valve in mind so that's another reason I favor it.

My surgery is scheduled on Dec 4th. Should I choose a MV or TV? Do I need to postpone my surgery or do CABG now and AVR later? My peak gradient were 42 mmHg in sept 2014, 46.4 in june 2016 and 50 in oct 2017, my aortic valve area is 1.09 cm2 (pretty much stable over last 3.25 years). I appreciate your comments and suggestions.

Thanks,
John

 

[hx77]

Sorry VR does not allow me to attach a picture. The Fig 3 in the paper is the one I want to attach.

 

[dick0236]

Welcome to this forum hx77. One thing is for sure......advances in the science of heart valve replacement will continue, so any treatments of yesterday and today will be replaced by the advances of tomorrow......and , as the old saying goes, "tomorrow never comes". Make the decision that you, with the help of your docs, makes the most sense in your situation. As many have posted in the past........"there are no bad choices" and no choice of today cannot be undone in the future, if or when, the magic forever fix is found.

 

[Paleowoman]

The first commercial implantation of INSPIRIS was performed in London in early June 2017, more than 8 months after it was approved in Europe in Sept 2016 (https://cardiovascularnews.com/firs...ces-inspiris-resilia-aortic-valve-take-place/) Why it took so long? Anyone knows when it will become market available in US?

If I choose a TV, i likely will do another AVR with TAVR. My aortic size is 23 according to my surgeon and he said i could have at least one satisfactory TAVR down the road. INSPIRIS line of valves are designed with valve-in-valve in mind so that's another reason I favor it..

From what I've read, the INSPIRIS valve will be out in the US in 2018. The INSPIRIS valve is tissue and is supossed to last as long as a mechanical valve and, as a result, they're planning to use them in younger people too. With the INSPIRIS you might not even need a redo at your age.

Here's something about the new valve on a UK heart valve website: https://heartvalvevoice.com/news/news/pioneering-heart-valve-implantation-procedures-performed-hea

 

[hx77]

Thanks **** and Anne for your comments. Anne, i am surprised it took so long to launch the product. As my surgeon said the concept is sound but it still needs be proved in clinics.

 

[Alchemist]

Hello

I've actually been in touch with Edward's 'Customer Care' UK today. I asked them which hospitals are they supplying with the Inspiris Resilia as I'm keen to arrange a surgical assessment with this valve at the top of my shopping list.

Although we read about it's pioneering use at Kings College London:

https://www.kch.nhs.uk/news/media/press-releases/view/23356

I was informed that only Cardiff Spire Hospital had ordered the Resilia? Further investigation is necessary...Indeed the nice Customer Care assistant did assure me that he would make more enquiries, I've also sent him the link above!

If anyone has more information about the availability of the Inspiris Resilia in the UK, private or NHS, I would be very grateful to hear.

 

[Paleowoman]

If anyone has more information about the availability of the Inspiris Resilia in the UK, private or NHS, I would be very grateful to hear.

These three London surgeons and hospitals have used it: Olaf Wendler, professor of cardiac surgery at King’s College Hospital, Toufan Bahrami consultant cardiothoracic surgeon at Royal Brompton and Harefield Hospitals, and Michael Sabetai, consultant cardiac surgeon at Guy’s and St Thomas’ Hospital. They all three do work both NHS and private.

 

[Paleowoman]

PS - read this from Cardiovascular News:: https://cardiovascularnews.com/firs...ces-inspiris-resilia-aortic-valve-take-place/

Here's some: "Olaf Wendler, consultant cardiothoracic surgeon at King’s College Hospital, who performed one of the two surgeries, says, “This new device represents a huge step forward in the advancements of heart valve treatment providing surgeons and their active patients with an improved, longer lasting, treatment option. Thanks to such modern advancements, heart valve disease patients can now live longer with an improved quality of life.”

"The world’s first two patients to undergo the surgery were 27-year-old Nosheen Khan from Croydon, UK, at King’s College Hospital, and a 44-year-old woman at Royal Brompton and Harefield. Together with a team of heart specialists, the aortic valve replacement surgery at Harefield Hospital was led by Toufan Bahrami, consultant cardiac surgeon specialised in minimally invasive valve surgery and Jullien Gaer, consultant cardiac surgeon."

 

[Nocturne]

I suppose the USA will get it ten years from now, for triple the cost.

 

[DJM 18]

Not a lot of new information here but the fact that Cleveland is involved is a strong positive in my opinion. However, while the initial data seems to be encouraging it will take many years to fully validate the thesis of durability for younger patients.

The below is from a posting from Cleveland Clinic regarding this valve...

https://consultqd.clevelandclinic.or...nger-patients/

The July FDA approval of the Inspiris Resilia aortic valve may signal an important advance toward more-durable bioprosthesis options for younger patients requiring aortic valve replacement (AVR), including potential enhanced suitability for future valve-in-valve procedures.

That’s the take of cardiothoracic surgeon Lars Svensson, MD, PhD, an investigator with the ongoing multicenter COMMENCE trial that helped form the basis for approval of the new bovine pericardial bioprosthesis. “If this valve holds up over time, we see tremendous potential for its use in younger patients,” says Dr. Svensson, Chair of Cleveland Clinic’s Sydell and Arnold Miller Family Heart & Vascular Institute.

“In animal studies, the treatment process strongly reduced calcification of the leaflets,” notes Dr. Svensson. “Encouraging data have also come from human studies in Eastern Europe.”

The significance of COMMENCE

COMMENCE is a single-arm investigational device exemption (IDE) trial in which 689 patients underwent surgical AVR with the Inspiris Resilia valve. Mean patient age was 67 ± 11.6 years.

Thirty-day and two-year mortality and complication rates were very low. Moreover, no structural valve deterioration, valve thrombosis or nonstructural valve dysfunction was seen over the two-year follow-up to date.

“The results of open surgical AVR were uniformly excellent,” says Dr. Svensson, but he adds that longer follow-up will be needed to draw conclusions about the valve’s durability.

“At 10 years, we may not see a difference in durability between dry and wet technology,” he observes, “but I expect we will start to see a separation at 15 years. The long-term data in young patients will be interesting. A more durable valve would be a game changer.”

 

[amarG]

I asked Dr Svensson about his valve when I met him last month. He was the lead investigator for this valve and is quite bullish on it. He said he had been pushing Edwards to let himuse the valve but they have not yet released it to him or in the US market. Dunno why Edwards is going slow on it even thought they got fda approval 6 months ago.

 

[Alchemist]

Many thanks Paleowoman for the links and information about the usage of the Resilia in the UK.

This has been confirmed by Edwards Life Sciences UK that the valve is currently being used by;

Kings College Hospital London
Basildon
Harefield
London Bridge
St Thomas
Royal Brompton

Whilst the Edwards rapid deployment sutureless Intuity Valve is available at;

Basildon Hospital
Bristol Royal Infirmary
Harefield
London Bridge
Royal Brompton
Southampton General
St Barts
St Thomas
Wellington

It is certainly an exciting time for valve development thought I must sympathise with the frustration that must be felt in the US.

 

[epstns]

It is certainly an exciting time for valve development thought I must sympathise with the frustration that must be felt in the US.

I agree that it is an exciting development, but I doubt that many experienced patients here in The States are unusually frustrated. The long delays have been a part of our system for many years, with mixed results. Sometimes these testing delays prevent ineffective therapies from reaching the patient market, while sometimes they delay the deployment of legitimate improvements. That Edwards' new development represents a real improvement, I accept, but I guess that we cannot choose when to apply full rigor in evaluation and when to "fast-track" things, so it is what it is.

I do appreciate reading about this, but since I've had my Edwards tissue valve for almost 7 years now, this wouldn't have even been on the radar at my decision point in time. If/when I need a re-do, I imagine that any of the then-current tissue valves will be fine for me, but developments like this could make it more certain that I may face only one re-do, if any.

Sharing information like this is one of the important reasons why this site exists, though. Newly diagnosed patients come here to learn about their options, and I thank you, John, for bringing it up for discussion. I'll be following it, myself.

 

[Nocturne]

I agree that it is an exciting development, but I doubt that many experienced patients here in The States are unusually frustrated. The long delays have been a part of our system for many years, with mixed results. Sometimes these testing delays prevent ineffective therapies from reaching the patient market, while sometimes they delay the deployment of legitimate improvements. That Edwards' new development represents a real improvement, I accept, but I guess that we cannot choose when to apply full rigor in evaluation and when to "fast-track" things, so it is what it is.

The USA is probably the BEST place on Earth to get medical treatment/management -- if you are rich, famous, or both. Take a look at how many people who contracted HIV around the same time Magic Johnson did are still breathing. Now why do you suppose that is?

 

[Agian]

Give us a hint Noc.

 

[hx77]

I thank you, John, for bringing it up for discussion. I'll be following it, myself.

You are welcome! I also benefited a lot from VR.org.

Just an update to my status: I am asking my surgeon whether it makes senses to postpone AVR as the structure of my av is pretty much stable over last three years. Mildly calcified leaflets, 1.1 cm2 opening. Gradients did deteriorate from a mean of 21.3 mmHg 3.25 years ago to 28 this year. I am symptomatic but most likely caused by the blockage of my coronary arteries. Even though doing AVR now could save me one OHS down the road, I worry i might give up my native AV too soon.

I did notice in the latest report, it's mentioned "Akinesis of the mid anterosptum, apical septum and inferoapex" for the left ventricle. Anyone knows how critical is this condition?

I will meet my surgeon again this Friday and my surgery is scheduled next Monday. Clock is ticking.

Any comments?

 

[Paleowoman]

Any comments?

Hi John,

I suppose there are several options for you to discuss with the surgeon:

Do CABG now on it’s own and have AVR when it's necessary - that’s two surgeries.

Do CABG now and have mech AVR now - that is one surgery only as you are not likely to need a redo AVR, though sometimes CABG needs to be done again..

Do CABG now and have AVR now with tissue valve and have TAVR down the line as your surgeon has suggested you could have - that’s only one open heart surgery.

Do CABG now and have AVR when necessary and then get the Resilia valve or even discover that any tissue would see you out as your current valve might last heaven knows how long - that would mean two surgeries.

All the while bear in mind that CABG isn’t always a once only thing and sometimes requires redo.

I don't envy you having to decide so soon - I hope you can have a good talk with your surgeon on Friday.

 

[hx77]

Hi Anne, Thank you for the suggestions. That's what on my mind too except I might not do mechanical valve because I am so easy getting cuts in hands as I cook/DIY at home. I hope I only need one CABG as I do not have the risk factors and my cholesterol level is normal (HDL 82, LDL 88). I also have already changed my diet so I would take in even less cholesterol. My surgeon Dr Takayama, a respectable person in field who was also involved in INSPIRIS clinical trial, is very responsive. He has replied most of my questions but he wanted to talk to me in person regarding whether I should do AVR now or not.

 

[pellicle]

except I might not do mechanical valve because I am so easy getting cuts in hands as I cook/DIY at home.

Personally I don't mind whst you choose to get but if your decision is based on what you wrote above it's the classic misunderstanding and totally off base.

Quite a number of us on warfarin home reno (with sharp steel, I was roofing a few weeks back), cook, hunt , fish (scale and clean with sharp knives), skin animals (which have been shot in hunting with sharp knives), ride motorcycles, ski ...myself I do almost all of that list.

Misinformed is not a good basis for a decision...and your issues raised above are to my eyes the first round excuses for "why I don't want warfarin"

Anwyay, as I said I don't mind what you pick, but just make sure its (as the surgical guidelines say) an informed choice.

Best Wishes

 

[hx77]

Hi Pell, I am glad you are living a full life. Warfarin is not only thing i worry about. The risk of getting stroke is a more important concern. I know the risk is low and stroke happens in patients with tissue valve implantation, but it's a real risk. BTW, what happen if you get a cut? Is it hard to stop the bleeding?

Thanks,
John