Percutaneous Info

[ron]

Hey guys,

Well, I am 9 weeks out of surgery and feeling well (just some trouble sleeping). I had my aortic stenosis replaced with an Edwards Bovine and my dilated root replaced with a dacron graft. This was all done 5 days after my 40th birthday.

At any rate, I just received a letter from Cedars-Sanai. It was asking for donations, as well as touting their skills and services. It stated the following:

"In clinical trials, we have performed more heart valve repairs and replacements without open heart surgery than any other medical center in the United States."

As some of you know, they are referring to Percutaneous Valve technology. I found it interesting that we have moved to the point where hospitals are beginning to advertise this technology here in the United States. I know that 50% of all valve replacements in Europe are currently being done percutaneously.

All in all, I think it is positive news for those of us who; 1.) Will have to replace a tissue valve someday; 2.) Have children who might also have defective valves;3.) People who face VR in the not so distant future.

Just passing the info on. Any comments are welcomed.

 

[Duffey]

Ron, thanks for passing the information along.
I am certain that I will have my bovine replaced one day, and I have a son and grandson who will possibly need replacement one day due to bicuspid aortic valves.
The percutaneous valve technology is of tremendous interest to us.

 

[Luana]

I know that 50% of all valve replacements in Europe are currently being done percutaneously.

Really? I've read about one-third of patients qualify for it, meaning they are too high risk for surgery.

 

[Lynlw]

Really? I've read about one-third of patients qualify for it, meaning they are too high risk for surgery.

I could be wrong, but I believe the "how high risk a surgery would be to qualify", is just for the trials.
Also for the corevalve trials now, patients that are "too high risk for surgery", can automatically get the valve, they no longer get broken down to some get the valve and others medical treatment (drugs) because in the Partner Trial (sapien) for that Arm the people who got the valve did MUCH better than the ones treated medically, so they didn't think it was right, to make anyone who wanted and qualified for the percutaneous valve, to end up just taking meds .. so the trial is for high risk, but still can have surgery (maybe 10-15 % risk of not making it) and like the one Arm in Partner, 1/2 the patient have OHS and the other the percutaneous valve.

Altho I 'm pretty sure the 50% of patient having their Aortic valve replaced percutaneously in Europe, is out of the total patients getting tissue valves, not all valve patients, altho that is still pretty many.

 

[ron]

Hello Lyn,

Yes, I believe you are right. That applies to tissue valves as far as I know.

 

[chaconne]

I have a friend who is a echo tech at the Kaiser Permanente Los Angeles Medical Center. This facility just started a clinical trial with the percutaneous valve replacement and he's been involved with it. He said that he's seen patents doing 100% better after only 2-3 weeks and was asking me if I would consider getting a tissue valve rather than a mechanical for a future re-do with this new method.

My cardiologist, who previously worked for Cedars-Sanai, said I was far from qualifying for this procedure now, but does anyone know if a re-do could be done over the current stented or stentless tissue valves? Can these valves be re-done over each other indefinitely? Does having a dacron graft exclude the possibility?

 

[ElectLive]

Chaconne - Percutaneous has been done in bioprosthetic valves in Europe, but not in the US so far, even in trials. They can definitely not be re-done indefinitely, each valve in valve procedure reduces the opening size, at a certain point it becomes too small. One of the most important factors for how many, if any, is valve size. You won't know this for sure until your surgery, but surgeons are able to make fairly good estimates based on pre-surgery scans such as CT. A few of us discussed issues such as these in a thread about a month ago: http://www.valvereplacement.org/forums/showthread.php?38586-Edwards-Wins-Panel-Support-to-Sell-First-Less-Invasive-Heart-Valve-in-U.S.

 

[Lynlw]

I have a friend who is a echo tech at the Kaiser Permanente Los Angeles Medical Center. This facility just started a clinical trial with the percutaneous valve replacement and he's been involved with it. He said that he's seen patents doing 100% better after only 2-3 weeks and was asking me if I would consider getting a tissue valve rather than a mechanical for a future re-do with this new method.

My cardiologist, who previously worked for Cedars-Sanai, said I was far from qualifying for this procedure now, but does anyone know if a re-do could be done over the current stented or stentless tissue valves? Can these valves be re-done over each other indefinitely? Does having a dacron graft exclude the possibility?

Chaconne, as Elect said they've done perctaneous valves inside tissue valves in Eurpore already and for Aortic valves, they have not done them in the US yet.
However the first percutaneous valves were for pulmonary valves and they've been doing them inside tissue valves for about 10 years in Europe/Uk and about 5 in the US. The Melody (pulm) percuationous valve has been approved in the US a couple years now, and yes they have used percutaneous valves inside older percutaneous valves already.

They can NOT keep inserting new perc valves inside older ones, but getting at least 1 more is possible with the valves available right now. When more valves are approved and everything improves, one of the first things companies will probably do is make more sizes available than there are right now. The Pulmonary valves are mainly used in children and young adults that are very active and come in smaller sizes already.

One of the things you might ask about is if certain valves would help in being able to have 1 or more percutaneous valves inside it. I know for a fact the Edwards Sapien (Aortic) valve was made to work with THEIR tissue valves, and the larger openings MIGHT help.

But to answer your question, one of the reasons many surgeons in leading centers are now reccomending tissue valves for younger people, is the high chance of having it be replaced by cath when the time comes. and having a graft wouldn't be a problem, some believe it is actually even easier.

 

[Julian]

I guess its perceived to be easier with the graft because there's less concern about damaging a native aorta when placing valves?

 

[Lynlw]

I guess its perceived to be easier with the graft because there's less concern about damaging a native aorta when placing valves?

And they know exactly what size it is.

 

[jhusker2]

I wonder if and when they will do this for the mitral valve? To date, I have reasearched and researched and haven't found anything promising. The only thing I've read points to a mitral clip which isn't going over so well.

Anyone hear anything different on the mitral?

 

[Lynlw]

I wonder if and when they will do this for the mitral valve? To date, I have reasearched and researched and haven't found anything promising. The only thing I've read points to a mitral clip which isn't going over so well.

Anyone hear anything different on the mitral?

They are working on a couple valves for Mitral valve percutaneous replacement, but for the most part I believe alot of the work for Mitral valves is different ways to repair them, either min invasive or percutaneously. Heres a pretty good, recent, (short) article discussing Mitral valves and the different problems and different ways they are working to correct them http://emedicine.medscape.com/article/1839696-overview#a15

this is the conclusion
"The field of percutaneous transcatheter MVR is evolving exponentially. These emerging technologies can be classified by their site of action and device mechanism. The proposed classification is based on therapies aimed at the leaflets (leaflet plication, leaflet coaptation, leaflet ablation), annuloplasty (indirect: CS approach or asymmetrical approach; and direct: true percutaneous or hybrid), percutaneous chords, and LV remodeling. Percutaneous edge-to-edge leaflet repair has been shown to be noninferior to surgery in a randomized trial.

Several other technologies—including various direct and indirect annuloplasty and LV remodeling devices—have achieved first-in-man results or are in preclinical testing. Most likely a combination of these technologies will be required for satisfactory MVRe. However, for many patients, repair will not be possible, and MVR will be required. Although significant challenges exist, several percutaneous MVR prototypes are already in development."

 

[jhusker2]

Lyn- Thanks for the fyi. It always nice to read promising info like the article you just posted. It gives us mitral valve replacement folks (tissue) hope down the road.

Jason

 

[Adrienne]

Very interesting!!!! Since I am worried that my MV repair may not hold up my whole life, it would be wonderful to have a percutaneous alternative to OHS. I wonder whether they can do some of the methods mentioned after a person has already had an MV repair.

 

[cherylchapa]

However the first percutaneous valves were for pulmonary valves and they've been doing them inside tissue valves for about 10 years in Europe/Uk and about 5 in the US. The Melody (pulm) percuationous valve has been approved in the US a couple years now, and yes they have used percutaneous valves inside older percutaneous valves already.

They can NOT keep inserting new perc valves inside older ones, but getting at least 1 more is possible with the valves available right now. When more valves are approved and everything improves, one of the first things companies will probably do is make more sizes available than there are right now. The Pulmonary valves are mainly used in children and young adults that are very active and come in smaller sizes already.

But to answer your question, one of the reasons many surgeons in leading centers are now reccomending tissue valves for younger people, is the high chance of having it be replaced by cath when the time comes. and having a graft wouldn't be a problem, some believe it is actually even easier.

My son actually has a Melody valve (inserted 8/11/11). It was placed inside of a 2 year old Edwards Carpentier Bovine valve. The next one will be surgically placed because he will need a larger valve by then. Laws of physics being what they are, you can't put a 19mm valve inside a 16mm hole so there ya have it.

That being said, the new percutaneous valves are a medical miracle if you ask me. We thought Chris was headed for a re-op after only 2 years and instead he had a cath and went home the next day. Now less than 2 months later, he's back to almost full activity. The only restrictions are contact sports, rope-climbing and runs of a mile or more.

While a mechanical valve was never an option for Christopher, one of the things that the cardiologist always touted was that he could possibly get a melody valve next time because the original replacement was tissue.

 

[enkaynj]

I think this topic deserves its own category rather then being located inside the valve selection category as this pertains to a procedure rather than a valve type...I think there will be tremendous interest in this topic in the coming years not just from new users but also those who already have had AVR's. I hope Hank can create a separate category for this. just my 2 cents.