Percutaneous Valve Replacement

[BackDoc]

I think the argument is really over nothing.

We will never see "peer reviewed studies using PVR, versus standard valve replacement, versus a placebo group" because we are dealing with a living, breathing population of valve patients.

Who here would be willing allow themselves to be placed into one of those three groups as a walking, talking, breathing lab rat?

However, if that were your only alternative due to other co-morbid medical complications I am sure we'd all say yes.

Right now the PVR is showing excellent promise as the method of choice for certain valve patients in whom surgery poses an unacceptable risk. In other words the risks of surgery outweight the possible benefits.

As these PVR recipients are followed over time, we will be able to extrapolate the data for use in other populations.

When some of the leading heart surgeons start to speak highly of the future potential of this procedure, I start to listen.

Whether this technology will ever progress past it's current stage is anyone's guess. Everyone could be sadly disappointed or we can be pleasantly surprised.

We each have to make our own informed decision. I made mine after hearing Dr. Boyd of CC tell me that he felt very good about this procedure becoming more common place in the future.

If I am wrong, then I am prepared for a re-operation in the future. If I am pleasantly surprised then so much the better.

 

[BackDoc]

http://www.circ.ahajournals.org/cgi/content/full/113/6/771

http://www.cardiosource.com/RapidNewsSummaries/index.asp?EID=13&DoW=Sun&SumID=75

http://ejcts.ctsnetjournals.org/cgi/content/full/26/5/873

http://www.ctsnet.org/sections/innovation/minimallyinvasive/articles/article-26.html

http://www.scai.org/pdf/AR_12-04_SCAI_Brodsky.pdf

 

[Karlynn]

I am still not seeing any direct information on studies being done, or about to be done on any group other than high-risk patients. There are a ton of articles - so it doesn't mean they aren't there or that they are. If those who believe that PVR will soon be available to the general valve population and soon after that be considered the standard of care - please post the articles or links that you feel are included in the 1000 + articles so we don't have to keep wading through to prove the point you are trying to making. Please solve the puzzle for us. Just about every article I have opened up and glanced through - some I have read thoroughly, some I've just skimmed (due to copious amounts of articles) all I read continue to refer to the new studies being done in high risk groups and the promise it brings for that demographic.

I have googled just about every possible combination I could in the last month or so using the following words: percuatneous, valve, replacment, high, low, risk, studies, trial/s, mechanical, tissue etc. So please don't believe I made an hypothesis and then set out to prove it. That is entirely not the case.

I fully believe that PVR is a fabulous thing for valve surgery - for specific groups. I have yet to read anything presented here that sways me from my original point of this thread - I believe we are not close enough to use in low-risk individuals to speak of it as if it's all but accomplished to those considering the many aspects of valve selection now. I'm not doing it with the On-X valves (currently going through low and no warfarin studies) and I won't support that conjecture with valve replacement. Will I offer it as hope for those members that join and say they've had 2 or 3 OHS surgeries so far and are considered high risk - absolutely.

Those who believe fully in wide PVR use soon have every right to continue to tell people that PVR is going to soon be the way tissue valves are replaced in the future. That is their right. But don't be surprised if those of us who believe it is very premature (just as in telling someone to go On-X because they won't have to take warfarin in 5 years is too premature) to exercise our right to post our disagreement and our reasons for our belief. It is about concern that new members going through the process have correct information. Unfortunately that means different things to different people and we have to leave it up to the individual to decide who they believe is right. It won't be up to us to get into debates with each other.

With that said - unless someone has concrete information to post regarding their conjectures (which I will gladly read), I think this thread has provided about as much information as it can without getting extremely redundant. I think we may be at a point where we just say we will respectfully agree to disagree.

I hope we all continue to keep up to date and explore medical advancements that affect all of us - PVR's personal application to my life is why I started my hunt for information in the first place. Let's keep doing it.

 

[ShezaGirlie]

Where's the pizza....

Where's the pizza....

Yes, I fully realize and recognize this webite http://www.corevalve.com/News.aspx does not mention low risk trials, but I feel it's of paramount importance for new members to have all the available information there is out there.

After all, just read (In the News) about the progress made in only three short years regarding percataneous valve replacement -- it gives all of us great hope..!

 

[cp172]

Life has a way of throwing curve balls. While PVR looks like the next evolutionary step in valve replacement what is the chance there is another less invasive more unorthodox procedure that will come along before PVR becomes the norm? Just thinking ouside the box.

Love all the various opinions in the VR Nation!

 

[Superbob]

I think the argument is really over nothing.

We will never see "peer reviewed studies using PVR, versus standard valve replacement, versus a placebo group" because we are dealing with a living, breathing population of valve patients.

Who here would be willing allow themselves to be placed into one of those three groups as a walking, talking, breathing lab rat?

However, if that were your only alternative due to other co-morbid medical complications I am sure we'd all say yes.

Right now the PVR is showing excellent promise as the method of choice for certain valve patients in whom surgery poses an unacceptable risk. In other words the risks of surgery outweight the possible benefits.

As these PVR recipients are followed over time, we will be able to extrapolate the data for use in other populations.

When some of the leading heart surgeons start to speak highly of the future potential of this procedure, I start to listen.

Whether this technology will ever progress past it's current stage is anyone's guess. Everyone could be sadly disappointed or we can be pleasantly surprised.

We each have to make our own informed decision. I made mine after hearing Dr. Boyd of CC tell me that he felt very good about this procedure becoming more common place in the future.

If I am wrong, then I am prepared for a re-operation in the future. If I am pleasantly surprised then so much the better.

Thank you for posting these links, BackDoc.

I also agree with your perspective on this. We can read all the available information and make up our OWN minds. No need for argument. Personally, when I decided at age 63 to go tissue, the possibility of a break-through like this in case I faced a re-op as an even older man was on my list of considerations, but was fairly far down the list. There are no guarantees -- in life or in the futures market for medical miracles. But obviously this procedure has potential -- even if it is limited to so-called "high-risk" patients right now.

 

[Karlynn]

Of course if we ever get the replacement valves made from our own stem cells, that will be the ultimate.

I eagerly read anything having to do with the use of our own stem cells because what you mentioned is what I truly believe is the hope of the future.

 

[Karlynn]

If I am wrong, then I am prepared for a re-operation in the future. If I am pleasantly surprised then so much the better.

I just realized that for some reason my first reply to this didn't make it into cyberspace.

I think this is a very healthy attitude to have. Hope for the best, prepare for the worst and be satisfied to land somewhere in the middle. (or this side of the grass.)

 

[Lynlw]

I do not have links, but this spring we talked to the docs at Boston Childrens about PVR and IF he needed his valve replaced this would have been an option and I just wanted to add his would have been to replace a tissue valve. Also i know of a 27 yo that also talked to them , she doesn't need it right now, but her would replace a homograph pulm valve. As far as I know most of the clinical trials done at Boston have been on children and young adults. There probably isn't much out there about it since the trials are pretty new.

 

[Rain]

Researching & posting links is fine and helpful....

Researching & posting links is fine and helpful....

.
But these folks have qualified doctors to “recommend” medical procedures.

I believe a site loses its value & purpose when ideas, thoughts & experiences are diminished. Without balanced discussion and freedom of opinion, many members will not post or participate in the exchange. In my view, this is clearly already happening.

Many, many people agree with you, sir.

 

[Lynlw]

Lyn, may I ask, when you say "replace" your son's tissue valve or the other young lady's homograft, do you know if were they talking about actually replacing those valves (as in removing the old valves and putting in new ones), or were they talking about inserting a new valve inside the old one? One issue that is of interest is how many times one could undergo PVR before the chest would have to be opened to, in effect, start over. Thanks.

I didn't get into details, because it ended up being his conduit that needed replaced, but my understanding was smash the old one since I don't know how they could remove the old one without opening the chest.(altho my guess in the future would be the cutting balloon they use for other things now) To be honest, I haven't paid as much attention to PVR as tissue engineered valves, since Justin is only 19 and his chest has been open 6 times (plus a right thoracotomy)so my big hope is next time he needs it replaced it will be of his own cells, now IF they could do a PVR with TE valves that would be the best, since hopefully that would be the last need to replace it.(and Boston is reasearching on both TE and PVR) Either way I just pray he stays out of the OR for a decade, that would be the first time in his life he made it that long.

 

[Lynlw]

Thanks Oaktree, i love him and am very proud of him

 

[Karlynn]

Hey Lyn! I was just thinking that I hadn't seen you on since I got back from my trip.

I remembered you talking about what was being done at Boston. I think I even googled "Boston" a while back when looking- doctors are probably too busy to write any reports right now if they are doing TE and PVR. I think these studies are great hope for the CHD population where multiple surgeries are the order of the day. Praying Justin doesn't have to see the inside of an OR for quite a long time.

 

[harleygirl528]

Too all those who are doing the exhaustive research on this issue, my hats off to you...and thank you. It is extremely helpful, particularly for those of us who are in the position of making valve choice. However, I do agree that the valve choice should not be made solely on the promise of future technology but the combination of all factors.

Oaktree, you had asked for those of us who were touting the likelihood of future PVR for non high-risk patient to name our source, even if it was our doctor. Well, with that said, I am more than happy to reveal and it happened to by my surgeon, Dr. Sharo Raissi, who runs the aortic surgery center at Cedars Sinai in Los Angeles. I am sure you (Oaktree) are familiar with him since you were the one who urged me to consult with him and told me that you personally considered him one of the top cardiothoracic surgeon in the entire country. In fact, you said that had you not been so sick you would have travelled to LA and used him yourself, as you were so impressed with him. However, you probably wouldn't have a mechanical valve right now since he is also the surgeon who told me he hasn't installed a mechanical valve in "years."

I just want you to know first and foremost that I will forever be grateful to you for the referral. He is phenomenal and it his opinion is that PVR "within the next ten years" will be an option for me and others who are not necessarily "high risk" surgical patients. I haven't sat and done hours and hours or research on it...I guess I trusted this man with my life so I sort of thought he probably knew what he was talking about.

I do think it is important to know that many experts in this field feel that PVR is a real "possibility" and I stress the word "possibility"....nothing is certain for sure and I don't think anyone is saying it is. I also want to clarify my earlier statement that I felt PVR would be available in the ?near future??.by near future what I should have said was within the next ten years. Near future can imply next month and I realize we are far from that. But in the world or medical research ten years isn?t that far off?considering that most tissue valves are expected to last at least ten years I think that many of us can at least HOPE for PVR next time around.

I think it is important to understand that the experts in this field are working diligently to perfect this procedure and are extremely hopeful for what the future holds.......a little hope never hurt anyone did it? Since I know for sure if I live long enough I will need a valve replacements (I had a repair 5 weeks ago) I am certainly hoping my next surgery will be a little less invasive...even being young and healthy this surgery has "kicked my butt" and even 5 weeks later I still wake up some mornings feeling like the train turned around and hit me again.
Keep the information coming....I appreciate the research you all do and I try and read all the links...I know it takes time and it benefits us all.

 

[shellyb]

As has been said many times before each person facing surgery needs to make the type of value they want decision for themselves. It is a difficult decision and I think all of us agree on that. This site is wonderful because of our ability to be able to share our thoughts on why and how decisions were made. My husband and I found a lot of value in the discussions on this site. We do need to remember to respect each other's ideas but can't we be mature enough to make comments in a respectful way. My husband and I spent over an hour visiting with my husband's surgeon at Cleveland Clinic and yes many of his comments were in regards to what he felt the future of value replacement surgeries will be like. We weighed all the pros and cons we received and made a decision. That's the best anyone can do. Being able to read posts on others lists of pros and cons has value for people in the presurgery situation.

It's late and I'm rambling but let's all be friends and keep the lines of communication open and friendly!

shellyb

 

[ALCapshaw2]

IF I were considering a Percutaneous Valve Replacement (it's not an option for me with a Mechanical Valve already in place), I would want to know how much of a restriction on output would result from the seemingly obvious fact that any valve shewn INSIDE another valve simply cannot have as large an opening and will almost assuredly have a higher pressure gradient for the heart to pump against than the original valve in it's undiseased condition.

I would like the see this issue addressed by some of the medical professionals who endorse PVR as the Wave of the Future in tissue valve replacement. A good question for those proponents would be "What limitations in exertional capacity will result from a PVR vs. a replacement valve of type XXX?"

FWIW I have NO DOUBT that PVR would be an Excellent Choice for someone who has no other options and would likely not survive (another) Valve Replacement Surgery or would have an otherwise undesirable outcome.

'AL Capshaw'

 

[Jkm7]

When I met with my surgeon at Mass General two weeks ago, I never asked about Percutaneous Valve Replacement. He brought it up. He said MGH is working on the procedure and while he did not say so, I sensed an optimisitc outlook. He specified, as posted here, the only patients it has been used on are those too ill for traditional OHS. Brigham and Women's is working on PVR. These along with other hospitals mentioned, are among the finest in the world. I hold hope they will perfect the procedure to the point of it being viable for many. I know they have a long way to go before that day.

In the event my surgeon cannot repair my valve, we have agreed he will use a bovine for replacement. I will hold out hope that when (if) it should ever be that I would need replacement, PVR might be an option.

I did NOT base my decision for a tissue valve (if necessary) predicated upon the even small chance of it, but it does give an iota of hope. Optimism for a person facing OHS within a week cannot be a bad thing as long as it it not out of the realm of a smidegeon of reality. IMO

 

[Ross]

I don't have the time to go through all the links presented, but if there is anything you think we need in must have references, please send them to me.

 

[harleygirl528]

I was just wondering....is PVR an option for people who have mechanical valves? If not, I just wanted to let Karlyn and Oaktree know that it is really commendable for the two of you to do all that research, especially considering it is a procedure that you won't ever be able to benefit from. That really shows your dedication for providing information, particularly considering the time I know you have put into all your research. From someone who possibly will benefit someday, I want to personally thank you.

 

[Karlynn]

Lorie, I stated previously that I began looking into the valve because my question was "Will this be something that may, some day, be possible for mechanical valves?" It is a question that was asked here more than once when we began reading about PVR here a year or so ago. My thought was: If it's going to be widely available for tissue replacement, is mechanical just a step or two behind? It stood to reason that it might be a possibility. We have members here with mechanical valves that are considered high risk if they need another surgery. I wanted to explore that possibility as well.

We have tissue valve members that continue to do extensive research on warfarin and post their finding here, for the reason that they someday may take the drug.

I get the impression that some feel we are saying that the fact that no conclusive data or published reports leads us to believe PVR for good-risk candidates is going to be generally available anytime soon is a "victory" in the tissue vs. mechanical "war". This would place all of us on the level of school children. I did not start this thread with that in mind, nor do I feel that way.

When someone chooses tissue, it's my prayer that their tissue valve last them a record length of time and that their re-surgery is extremely easy. Just as if someone chooses mechanical, it is my prayer that their valve will last a lifetime with no clot or bleed incidents. Unfortunately the reality is that we will have members who's experiences with either valve type will be and have been disappointing for them.

I have advised women who wish to have children that a tissue valve is the better way to proceed. It is possible to bear children with a mechanical valve. We have members here who have done it. It still is much riskier than with a tissue valve so I do not feel comfortable telling them to get a mechanical and then have children. All I'm saying is that we are being premature in telling people that "the likelihood that future valve replacements are almost certainly going to be done percutaneously" (a direct quote from a post) is very premature and not a good statement in regards to someone who is 15, or 25 or 30, who will have much less of a life span on a tissue valve than a 55 year-old. If they continue to choose tissue they may not have the same outcome of durability and longevity with PVR as they would with the standard open-chest procedure. It simply is not known yet, nor even being explored fully yet.

PVR is fabulous news for high risk candidates!