Tissue Valve and Future Percutaneous Replacement

[canon4me]

I just received a tissue valve at Cleveland Clinic and 57 years young. A. Marc Gillinov, MD, my surgeon stopped just short of a guarantee that I will receive a percutaneously placed aortic tissue valve replacement when the time comes due. Cleveland Clinic is in an active trial currently placing them in high-risk patients with huge success.

http://www.ncbi.nlm.nih.gov/pubmed/23410766

 

[Jkm7]

Massachusetts General Hospital, where I had my heart surgeries, also is very actively working at percutaneious replacements and has been for years. This is not a brand new technology. There are a number of people who have already successfully received such replacements.

 

[ElectLive]

The latest of many Cleveland Clinic webchats on TAVR happened about a month ago: http://my.clevelandclinic.org/heart/webchat/1508_valve-disease-and-percutaneous-treatments.aspx#. There's always a lot of ongoing new information for those with interest.

One things to specifically point out: included is mention of Partner IIA. This newer study is not very well known, kind of under the radar at the moment actually - certainly in comparison to the initial Partner study. But anyway, what makes Partner IIA more intriguing is that the cohort criteria is now lowered to intermediate risk patients, with as little as 4% mortality risk patients now able to enroll. Many of the drawbacks/risks to TAVR are somewhat hard to distinguish from the high risk patient group make-up, so it will be interesting to see results in progressively lower risk patient groups as time goes on.

 

[chaconne]

This is an interesting point. I wonder why I never hear of anyone being trialed on warfarin before their surgery to see how they would do? After all there would be no harm in a 3 month or so trial to see if there were any incompatibilities for the patient.

Seems a logical and prudent step in light of your experience. As you say after surgery is a bad time to find that out. Just because many have no problems does not mean some won't.

My cardio did offer to let me try Warfarin before I had Valve surgery. I decided not to since I didn't want to hasten any problems and decided to wait and take the risk of not doing well on the drug.

 

[pellicle]

My cardio did offer to let me try Warfarin before I had Valve surgery. I decided not to since I didn't want to hasten any problems and decided to wait and take the risk of not doing well on the drug.

I don't understand how a trial would hasten anything? There is no evidence of warfarin having any lasting effects or causing problems once ceased.

 

[pellicle]

a percutaneously placed aortic tissue valve replacement when the time comes due. Cleveland Clinic is in an active trial currently placing them in high-risk patients with huge success.

http://www.ncbi.nlm.nih.gov/pubmed/23410766

Wow, looking at those rates my first thoughts are "how do you call this good"

RESULTS: Thirty-day mortality for PARTNER A was 3.4% for transcatheter aortic valve replacement and 6.5% for aortic valve replacement; 1-year mortality was 24.2% and 26.8%, respectively (P = .001 for noninferiority).
....
For PARTNER B--transcatheter aortic valve replacement versus medical treatment-30-day mortality was 5.0% versus 2.8% (P = .41), and at 1 year, mortality was 30.7% versus 50.7% (P < .001), respectively.
....

I had no idea that mortality rates of 6.5% was correct for AVR, nor that one year mortality was 26% either.

I can only suggest that this study must be looking at a specific subset of candidates.

 

[ElectLive]

I had no idea that mortality rates of 6.5% was correct for AVR, nor that one year mortality was 26% either.

I can only suggest that this study must be looking at a specific subset of candidates.

Most definitely, this was high risk patients. Last time I looked (a year or two ago), Cleveland Clinic's overall mortality rate for AVR was under 1%, well under in fact, approaching 1 in 400.

 

[pellicle]

Hi

Most definitely, this was high risk patients.

I re-read after I posted but didn't want to obsess over my post too much ... but its good to make that point clear that it was the high risk patients getting the better outcomes.

I wonder if the 'normal' patients would fare better or would fare about the same?

Way too many variables for me to fully grok the meaning.

Nonetheless, it is only a good thing that more operative techniques are developed and improved to give a wider array of options for all comers. The diversity of peoples needs and situations is often troweled over in the presentations of statistical summary.

 

[Jkm7]

My cardio did offer to let me try Warfarin before I had Valve surgery. I decided not to since I didn't want to hasten any problems and decided to wait and take the risk of not doing well on the drug.

You have put words as my quote that I did not post.

Originally Posted by jkm7
This is an interesting point. I wonder why I never hear of anyone being trialed on warfarin before their surgery to see how they would do? After all there would be no harm in a 3 month or so trial to see if there were any incompatibilities for the patient.

Seems a logical and prudent step in light of your experience. As you say after surgery is a bad time to find that out. Just because many have no problems does not mean some won't.

Could you kindly edit your post and remove those words represented as being mine?

Thanks.

 

[AZ Don]

In reviewing valve options, I read the data on one of the tissue valve websites. They expect their new valves to last 20 years in most patients. That's a long time for surgical techniques to improve.

 

[canon4me]

In reviewing valve options, I read the data on one of the tissue valve websites. They expect their new valves to last 20 years in most patients. That's a long time for surgical techniques to improve.

Don, that gives hope to patients like myself with a tissue valve. It can only improve. Hubert Humphrey years ago fashioned a statement......he said, "The way my luck runs, I would die of cancer on Wednesday and on Thursday they would find a cure for it."

How fortunate we all have to feel that we are living in the 21st century and not the Middle Ages.

 

[Classtime Sailer]

I got a tissue valve knowing that I would be getting it replaced eventually. My surgeon (Dr. Vaughn Starnes) does some percutaneous installations now and I expect the procedure to be quite common when my time is up.

 

[ElectLive]

Who will do the percutaneous replacements when they become routine?

Will it necessarily be cardiothoracic surgeons or even more likely interventionist cardiologists?

Or will there be a 'turf war'?

I should mention first that this post I'm quoting directly above was actually in another thread, but I think (hope :redface2 it may have been meant for here. In any case, the answer for now and likely for a while is both, doing different things. For more specifics, see page #25 (1363) here: http://ats.ctsnetjournals.org/cgi/reprint/93/4/1340.

 

[Jkm7]

I should mention first that this post I'm quoting directly above was actually in another thread, but I think (hope :redface2 it may have been meant for here. In any case, the answer for now and likely for a while is both, doing different things. For more specifics, see page #25 (1363) here: http://ats.ctsnetjournals.org/cgi/reprint/93/4/1340.

Yes, thank you.
I did mean to post the question on this thread but posted in another by mistake.

 

[chaconne]

I don't understand how a trial would hasten anything? There is no evidence of Warfarin having any lasting effects or causing problems once ceased.

At that point I had already chosen to have a mechanical valve, whether or not Warfarin was going to cause me problems. If Warfarin was going to cause problems for me (which it has not), I didn't want to start dealing with those problems before I had to (after AVR).

 

[Luana]

Massachusetts General Hospital, where I had my heart surgeries, also is very actively working at percutaneious replacements and has been for years. This is not a brand new technology. There are a number of people who have already successfully received such replacements.

Yes, and they're elderly, in frail health and too high-risk for traditional valve surgery, and are also having a higher rate of strokes post-op.

 

[ALTSELGREEN]

Interesting discussion-My son had a Medtronic Freestyle tissue valve fitted in November of 2012 at the age of 18. There is no data on how long this valve will last him, as not many youngsters his age have them.
He would have had a Ross, but he was not a good candidate as his pulmonary valve was dimensionally incompatable. We had 10-15 years banded about as a theoretical time frame for the life of the valve, but given his age I am not so sure. We were also told it would be very unlikely he would have to have OHS again. As and when, the next procedure would be almost certainly be percutaneous.

 

[VegasBAV]

Interesting discussion-My son had a Medtronic Freestyle tissue valve fitted in November of 2012 at the age of 18. There is no data on how long this valve will last him, as not many youngsters his age have them.
He would have had a Ross, but he was not a good candidate as his pulmonary valve was dimensionally incompatable. We had 10-15 years banded about as a theoretical time frame for the life of the valve, but given his age I am not so sure. We were also told it would be very unlikely he would have to have OHS again. As and when, the next procedure would be almost certainly be percutaneous.

This is interesting. I also got a tissue valve in Novembe 2012. I'm 41. My surgeon told me that he thinks it will last 15 years. He also told me that he thinks my next replacement will still be surgical, but the one after that will be percutaneous.

 

[neil]

just gonna throw a curved ball in here, i know in the future i will need another valve which i am settled with, not looking forward to it but settled about it, i will be honest and say i dont mind the idea of ohs to replace my valve as i kinda look at it as your opening the bonnet of the car to work rather than do it through the grill lol, any problems and your better placed,i know thats a simple way of looking at it but just my opinion,

 

[Rachel]

just gonna throw a curved ball in here, i know in the future i will need another valve which i am settled with, not looking forward to it but settled about it, i will be honest and say i dont mind the idea of ohs to replace my valve as i kinda look at it as your opening the bonnet of the car to work rather than do it through the grill lol, any problems and your better placed,i know thats a simple way of looking at it but just my opinion,

I'm with you Neil - OHS is fine with me because I kind of think it's better to see what's going on when everything is opened up - but I'm not a doctor so I don't know. If I have OHS next time, then I'm good with that. If by the time I'm ready for a third one and they do the percutaneous procedure well then that's fine with me too.

If my current tissue doesn't last too long and I'm looking at more than 3 surgeries, well then mechanical will be my choice - but all this is an unknown right now - best to keep an open mind.


Rachel