TAVR/TAVI: Recall of SAPIEN 3 Ultra Delivery System Due to Burst Balloons During Surgery

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hx77

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If you can email me I can give you the email for his nurse and she will be happy to see if you are a candidate. Is there a way to do that privately? They looked at my echo via email when I started my journey...
Thanks a lot! I have a g--mail account. The handle is "hx201801". I hope you could compose it.

John
 

Suckyvalvegurl

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I just tried sending you that info John. Let me know if you get it. My email comes from my work so also check your spam folder.

Let me know.

Kim
 

Protimenow

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You can send a private message using this system. Just place your mouse over the name of the person you want to contact. After the name pops up, click 'Start Conversation' and you can send a private message. You should be able to put contact information into that message string.
 

pellicle

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Being "in the business" I can assure you that is not the attitude
come on man ... nobody wants "the truth" ... they want their personal fantasy of how they model the world in their mind and filter out the facts that don't fit that ... they have to do that or it would confront their "belief system"
 

pellicle

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The surgeons I talked discouraged even the mini-sternum cut as it cuts down on their visibility, so going between the ribs for valve replacement seems like too much risk.
Not wishing to shed information on this discussion of anecdotes:
https://www.annalsthoracicsurgery.org/article/S0003-4975(10)02117-X/fulltext

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4791314/

https://www.ncbi.nlm.nih.gov/pubmed/28099179

which would support the view that its not actually harmful, may make a difference in some areas but isn't "ball tearingly" different in outcomes. Personally I know from working in tight spaces in my motorcycle engine that its all good when its all going to plan, but when anything "unexpected" occurs then I want to rip all the covers off and get at that thing properly.

So I would suggest from my metaphor (and these studies inclusion and exclusion criteria) that one needs to be a candidate for this in the proper analysis of the facts (you know, medical imaging ...) rather than just "want tickets to the game" ...
 

Keithl

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I agree, those were enlightening. I still fell exceptionally lucky, my recovery was extremely uneventful. The only reason I was in the hospital more than 4 days was they would not release me until my INR was over 2.0, otherwise I had surgery on a Thursday and was supposed to be discharged on Monday, but it took until the following Thursday to get my INR to 2.0.
 

rich01

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Aug 23, 2018
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@Ladybug

I'll be waiting for your report on how it goes. I'm having TAVR using the Medtronics valve on Sept 23.
My cardologist recommended changing from the Medtronics valve to the Sapien (not Ultra) valve. He says the Sapien proved superior to surgery and that access back into the heart in the future is a little easier with the Sapien over the Medtronics. This Sapien does not use the delivery system in the FDA warning. I believe this version is just called The Sapien 3.
 

Protimenow

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I agree, those were enlightening. I still fell exceptionally lucky, my recovery was extremely uneventful. The only reason I was in the hospital more than 4 days was they would not release me until my INR was over 2.0, otherwise I had surgery on a Thursday and was supposed to be discharged on Monday, but it took until the following Thursday to get my INR to 2.0.
I can sort of understand their reluctance (especially for legal reasons - covering their butts) that they didn't want to discharge you until your INR was over 2.0. It's another day of billable service. However, if you've been taking warfarin for a while, and know what your regular dose is, it should have been pretty clear that your INR would return to its normal range within three days of resuming it, whether you were tied up in a hospital bed, or at home.

I've had minor procedures in the past, dropped my INR below 2.0 for the procedure, and I've done fine getting my INR back up into range after three days of my standard dose.

Sure, it's good to be overly cautious. It probably makes sense to keep you until your INR gets above 2.0 (even though they probably know that it will, regardless of what they do). For me, if I was responsible for paying for anothe hospital day, I may even leave against medical advice, knowing that I can do daily testing to assure that my INR quickly snaps back into range.
 

Ladybug

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My cardologist recommended changing from the Medtronics valve to the Sapien (not Ultra) valve. He says the Sapien proved superior to surgery and that access back into the heart in the future is a little easier with the Sapien over the Medtronics. This Sapien does not use the delivery system in the FDA warning. I believe this version is just called The Sapien 3.

Im having TAVR on Thur 9/19/19. My Dr called me about a week ago and said that I have a tiny woman’s measurements and the best fit he can get is with the Medtronic Evolute Pro. So, at some point I have to give control over to my dr who has done 700 TAVR’s. I’m requesting to be conscious enough to know what’s going on so I can hear them talking. The dr was reassuring and said he expects it all to go very smoothly. They are, at my insistence, using a Sentinel filter to catch the calcium.
 

rich01

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Aug 23, 2018
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Im having TAVR on Thur 9/19/19. My Dr called me about a week ago and said that I have a tiny woman’s measurements and the best fit he can get is with the Medtronic Evolute Pro. So, at some point I have to give control over to my dr who has done 700 TAVR’s. I’m requesting to be conscious enough to know what’s going on so I can hear them talking. The dr was reassuring and said he expects it all to go very smoothly. They are, at my insistence, using a Sentinel filter to catch the calcium.
Good luck. I'm pretty comfortable about my upcoming TAVR. The cardiac cath and PCI procedures were both pretty easy with no pain. Just want to get it behind me so I can start "playing" again.
 

hx77

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Hi @Ladybug and @rich01: good luck to your procedures!

I am also very interested in getting a TAVR. But I am not qualified yet because of age limit.

@Ladybug: Evolut-R has better hemodynamics, i.e. low gradients and large valve open area.
 

pellicle

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Age limit for TAVR ?
normally it is a lower age limit (the older the better). Depending where you are there is always some surgeon who is wanting to break barriers, be the first to publish (and doesn't really give a flying about your out comes). Ultimately if you have a pulse you can find someone to put you on the slab.
I feel this summarizes how many surgeons see all heart valve patients
 
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hx77

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Nov 24, 2017
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US
TAVR has been approved for low risk patients in US. But for patients with bicuspid vavles, the age limit is 60. Under 60, insurnace does not cover the procedure. At least this is what my doctor told me.
 

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