two days before surgery.. surprising surgeon proposal

[charles g]

Needless to say I was quite surprised two days before surgery today dr.aldea at the uwmc seattle gave me an option for an Investigational Pericardial Surgical Aortic Heart Valve. Apparently I am a qualified candidate for the clinical test (650 candidates worldwide) using the medtronic Model 400 aortic valve bioprosthesis. I need to give the team an answer this tomarrow as I'm scheduled for surgery on Thursday. What better place to ask then here regarding what your feelings are..there is certainly some positives if I ever need a reop down the road since this new valve is built to accommodate a tavr type replacement. Here's a link:

http://newsroom.medtronic.com/phoenix.zhtml?c=251324&p=irol-newsArticle&id=1982437

http://clinicaltrials.gov/ct2/show/NCT02088554

It's so tempting since I'm a 68 yo male with a chance of needing a reop in <10 yrs but no time to really think on this.

charles gamet

 

[camgough]

Wow that's a lot to consider! It looks interesting to me and if I were in your shoes I would definitely consider it!

 

[epstns]

Charles,
I would, with all due respect, suggest that you review the valve life data among the other tissue valves now in use. Yes, it is possible that at age 68 you might need another within less than 10 years, but that is not the norm. The current (third) generation of valves from companies such as Edwards Lifesciences are all projected to have longer life spans than 8-10 years. This is why centers such as Cleveland Clinic have, for some years, been implanting tissue valves in the majority of their aortic valve patients who are in their mid-50's or older. Some (most?) of the second generation valves are still in service past 20 years - and the third generation valves are expected to last even longer.

I'm one of the cautious ones. I would ask yourself why you would want to participate in this trial. If the proposed trial valve has some real benefit to you, then by all means, go with it. If it is just "we think it will last longer" then I might tend toward being conservative and choosing one of the valves that has been in use for a few years and has some history data available.

BTW - I had my tissue aortic valve implanted at age 63, and my opinion is that my need for a re-operation is only a "maybe." Not at all definite. This valve could last well into its 20's, as some of its predecessors have.

 

[Northernlights]

I do think this should not have been sprung on you with 2 days to go!
I'm with epstns on this one.
I read the links and also watched the little youtube video which gives a bit more detail. In the video the hemodynamics / orifice area is described as 'probably one of the best there is of prosthetic valves out there' . The video also mentions the anti-calcification treatment 'which has been highly successful in preventing calcification in other valve leaflets'.
This strikes me as a 'catch-up' valve from medtronic. Medtronic at present just has the rather old porcine valves Hancock, and mosaic. Their hemodynamics have been unfavourably compared with the Edwards perimount magna and St Jude Trifecta, and porcine valves are not seen as so durable. Medtronic's equine valve, the 3 f, has not proved popular. So, to get back its market share, medtronic has to produce a bovine valve to rival the Magna and trifecta.
So this is probably going to be a good valve - better than the mosaic and hancock and much like the magna and trifecta, but unlikely to be a game-changer in any way. The main plus of the trial is good follow-up - the downside is that it is still a trial, when there are good non- experimental alternatives out there, and your surgeon will inevitably not have implanted many (though it does say the valve is easy to implant).
T he new medtronic valve can be used for a future TAVI valve-in-valve , but that goes for the magna and Trifecta too (though the magna may be better for TAVI as the trifecta has a possibility of coronary obstruction): the most important aspect for future valve-in-valve is using a large original valve: at least 23mm - 25 mm or above would get the best possible hemodynamics.
Which valve was your surgeon originally going to use?

 

[tom in MO]

I do not know the science or politics, however this statement "Safety of the valve will be evaluated by the time-related incidence of valve-related adverse events and death" would give me pause. What advantage do you get from this valve, easier future replacement? If that is the only reason, I would not take the plunge, especially given the short notice.

 

[pellicle]

Hi

Needless to say I was quite surprised two days before surgery today dr.aldea at the uwmc seattle gave me an option for an Investigational Pericardial Surgical Aortic Heart Valve. Apparently I am a qualified candidate for the clinical test (650 candidates worldwide)
...
It's so tempting since I'm a 68 yo male with a chance of needing a reop in <10 yrs but no time to really think on this.

what were you originally thinking of getting?

I feel about the same as everyone who has posted so far.

Best Wishes with the surgery (which will be soon if not already)

 

[charles g]

I called the research team and will not participate. Your very helpful suggestions and comments did the job and it was the way I was leaning anyway.

stressing alittle today ...it's a 0630 in the morning procedure so I'll hopefully be back in a week or so for post surgery comments but for now..thanks

 

[skeptic49]

NORTHERNLIGHTS wrote:

> (though the magna may be better for TAVI as the trifecta has a possibility of coronary obstruction)

More info...references on this please.

My surgeon has recommended the Trifecta for my Bentall with his strong assurance that any future re-do will in all probability be doable via TAVR. Since he will be re-attaching my coronary arteries into the graft himself, why would there be any special concerns in regard to future TAVR-related "coronary obstruction" with his valve of choice? I can't believe that he would recommend the Trifecta under these circumstances unless he is confident that there are no special concerns relative to potential TAVR re-dos. In fact, he has suggested in writing to me that multiple valve-in-valve re-dos will probably be possible.

 

[cldlhd]

NORTHERNLIGHTS wrote:


More info...references on this please.

My surgeon has recommended the Trifecta for my Bentall with his strong assurance that any future re-do will in all probability be doable via TAVR. Since he will be re-attaching my coronary arteries into the graft himself, why would there be any special concerns in regard to future TAVR-related "coronary obstruction" with his valve of choice? I can't believe that he would recommend the Trifecta under these circumstances unless he is confident that there are no special concerns relative to potential TAVR re-dos. In fact, he has suggested in writing to me that multiple valve-in-valve re-dos will probably be possible.

I'm sure he would put the coronaries where it wouldn't be an issue. I was watching a webinar last night with Dr Allan Stewart and he said he expects this generation of tissue valves will last 20 yrs. He went as far as to say if he needed a new aortic valve at his age ( 45 ) he would get a tissue and if it lasted close to 20 yrs by then TAVR would be a more mature technology.

 

[Northernlights]

Hi skeptic49
Sorry to worry you unnecessarily by my brief remark, it is really a minor disadvantage of the Trifecta, which doesn't make it unsafe at all, but means the surgeon needs to be aware and care must be taken ( obstruction is basically human error).
The risk of coronary obstruction is more frequent in TAVI than in surgical valves, mainly because precise positioning is at present more difficult (3.5% rather than 0.7%). There are a number of risk factors for this complication, including valves which like Trifecta have the leaflets attached to the outside of the stent. This just means the operator has to be careful to make sure the leaflets don't obstruct the coronary ostia when the TAVI valve is placed inside and the Trifecta leaflets are displaced. If you download the very useful free 'Valve-in-Valve aortic App' and go to Trifecta you will see under the guidance notes for using the Sapien and Corevalve within the Trifecta they say, 'possibility of coronary obstruction as leaflets are sutured outside'.

You asked for the info, and you can obviously find more in academic discussions of coronary obstruction, but I really don't want it to cause you unnecessary anxiety. Like valve replacement TAVI is an amazing complex and skilled procedure, and there are minor advantages and disadvantages in ease of implantation for all these valves, just as with tissue v. mechanical.

I know you have an excellent surgeon, however I must admit i do think he is jumping the gun a bit in suggesting future multiple valve in valve redos, though it's unlikely that you will need a second valve anyway. I suspect the best thing for all of us is to stay in as good as shape as possible to keep our options open , and as I keep saying, size is the most important element for a successful TAVI!

 

[skeptic49]

Thanks for the explanation...like you say, there are challenges to all of these procedures.