Has anyone done TAVR on this board in last 2 years that was NOT high RISK?

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Coryp, I am a surgical nurse in the O.R and I do TAVR surgeries weekly. And I have noticed that the criteria is easing for patients of lesser risk; when we first started TAVR program it was for the very sick and those deemed "inoperable" for conventional open heart valve replacement; and although my noticing is anecdotal (not scientifically verified), it seems the population is a bit more healthy. Below is a paste and copy from a web site:

MedStar Heart Center will be the first in the nation to launch a clinical trial, evaluating the use of a minimally invasive procedure to replace narrowed heart valves in patients who are considered at low risk for death from surgery. The Food and Drug Administration granted an Investigational Device Exemption, which allows MedStar Heart to use the investigational device in a research setting, and to enroll these patients into the study, which is starting this month. For decades, traditional open-heart surgery has been the gold standard for treating patients with severe aortic stenosis, an abnormal narrowing of the aortic valve in the heart. The only effective treatment is to replace the heart valve. The procedure, called TAVR, for transcatheter aortic valve replacement, is currently FDA approved for patients who are inoperable or too high-risk to undergo the open surgical procedure.
With TAVR, instead of opening the chest, physicians insert a new valve using a catheter threaded into the heart through a small incision in the groin or chest wall.
Trials are currently underway to investigate the use of TAVR in patients with intermediate surgical risk. However, the new study at MedStar Heart will be the first in the U.S. to investigate whether the results of TAVR in these patients are comparable to a lower-risk population.

hope that helps, when I do next weeks TAVRS I will question my surgeons and the TAVR reps that are always there what the FDA legal expectations and restrictions are and get back to you and this forum

we mainly place the Edwards Sapien valve, but we also do use the Medtronic Corevalve
 
Faramacho
Faramacho;n865545 said:
Coryp, I am a surgical nurse in the O.R and I do TAVR surgeries weekly. And I have noticed that the criteria is easing for patients of lesser risk; ...

as one who has spent a number of hours on the phone listening to and offering views to Cory I'd ask you to respond to some of these questions:

* how would you describe the health of the people who get TAVR? Are they otherwise active healthy people?
* what sort of age ranges are you seeing?
* have you done any followup with those patients (say, perhaps seen them again somewhere) in the following years? I know that hospitals focus on 30 and 60 day mortality, but what are their lives like say 5 or so years down the track?

One of the things Croy is struggling with is how it will impact his health long term and the trade off for convenience in his busy schedule in the short term. He has conveyed to me that for him, he's told that he can have a TAVI then a valve in valve replacment one more time (I think its two in total, perhaps you can confirm that sort of facts) then after that he'll need another surgery to replace that system and at that point he'll perhaps be having a mechanical.

As I understand it he's being elevated to 'intermediate' risk simply on the basis that he has had one valve done, and this will be a redo (I suggest those who downplay the risks of redo should consider that point carefully) .

As he's been told that it may be about 5 years duration before a valve of this nature packs it in on someone who's young and active, do you know what sort of problems / stats people who are having a valve in valve require?

As you are a surgical nurse in the O.R. I thought you may actually have knowledge that those of us who simply research these topics have.

Thanks
 
Pellicle, sorry it took so long to get back to this; to your first question the health of the patients we do TAVRS on varies; some are a wreck in-that they have severe AI (Aortic Insufficiency) to moderate AI. The ages range from usually high 70's to believe it or not some patient well into their 90's, I think the oldest we've done was 96.

As you can imagine the comorbidity of these patients sometimes is great. they are usually far from "active healthy" people; as you know severe AI can be very incapacitating; as far as follow-ups go, I only see them in the O.R and never post-operatively; which is why I spend time on these boards. As a medical writer and a surgical cardiac nurse, I want to get a feel for what the patient experiences weeks to months after surgery and what their concerns are.

I don't know Cory's age, but yes we have done VIVRS (VALVE IN VALVE REPLACEMENTS), what the doctors get concern with is a valve in valve constricts the orifice of the opening; in other words every time you put a valve in the opening closes that much more. However, most "young" patients are usually guided to a open heart traditional mechanical valve right from the get-go...however, mechanical valve means the patient must be on a blood thinner for the rest of their lives, which for some is no problem, but for others it frightens their life-style; patients 65 and below where I work are usually getting a mechanical valve.

the risks for Valve in Valve statistically I do not know; but as I stated earlier I will try to ask all these questions on my next TAVR . We did 4 TAVRS last week in one day , three femoral and one thru the direct subclavian artery; unfortunately those were on my day off.

And by the way, as far as "actual knowledge", I am always amazed and humbled by the great amount of knowledge people like you and others have on this forum; I learn sooo much from reading these posts and I appreciate all the research and experience that is offered here and other forums.
 
well folks Cory is back home now and is perhaps the first younger person to get a TAVI. I'll write a post with some of what he's sent me on a new thread
 

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