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

[hx77]

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]

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]

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.

 

[Suckyvalvegurl]

Thanks!

 

[pellicle]

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]

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]

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]

@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]

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]

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]

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]

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.

 

[hx77]

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

Hi Kim,

Sorry for the late reply. I received your email. Thanks for the information!

Best regards,
John

 

[newarrior]

Age limit for TAVR ?

 

[Protimenow]

Age limit for TAVR ?

So far, I haven't heard of any being done on people above 120 or over 2 years. (In other words, I don't really know)

 

[pellicle]

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

 

[hx77]

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.

 

[newarrior]

I have an On-X. Yes, it ticks. But it doesn't bother me. Warfarin? Meh. Easy Peasy.

I have thought about the ticking though. For a fella it would be like a novelty. I wonder what it would do for a young woman's self esteem though. A young girl might be more self conscious about it than a fat old git like me.

We had a lady here recently who said she wanted to find a partner who could understand. I also met a guy in cardiac rehab who seemed depressed and said he was waiting for it to stop! I reckon he would have been depressed anyway.

Check out CT Fletcher talking about it on YouTube.

Anything that indicates you are less than healthy will be a turn off when dating....It's hard wired into our lizard brain to seek out a healthy partner to produce healthy children....Women want security; a man with cardiac issues is warning flag that you may not be able to live long, provide for a woman's security etc etc

 

[newarrior]

Hi @LoveMyBraveHeart There are two things that are supposed to protect the Inspiris Resilia valve from calcification/stenosis:
"1. Blocks Calcium Build-up. The INSPIRIS valve uses the RESILIA tissue, a new type of bovine (cow) tissue with special technology that blocks calcium build-up on the valve." (A friend who got one told me it's a bit like a teflon coating)
"Reducing calcium build-up is important because calcium build-up is the main cause of tissue valve failure. The new RESILIA tissue has demonstrated significantly less calcium build-up in animal studies.*"
"2. Dry Storage. Most tissue valves are stored in aldehyde liquid which attracts calcium. Thanks to the unique RESILIA tissue, the INSPIRIS valve can be stored dry thereby preventing further exposure to the aldehydes."
From this article: Breakthrough: INSPIRIS RESILIA Aortic Valve Gets FDA Approval

Are these claims real or just marketing hype ?

 

[nobog]

Anything that indicates you are less than healthy will be a turn off when dating....It's hard wired into our lizard brain to seek out a healthy partner to produce healthy children....Women want security; a man with cardiac issues is warning flag that you may not be able to live long, provide for a woman's security etc etc

You need to stop thinking about every possible negative - about everything!

I was scared as he!! when I was in my 20's to get married as I watched my relatives age and become sick, and some wound up in "nursing homes". What if my wife to be was in a car accident and was disabled? What if something happened to me and I wasn't able to provide?

I knew I was ready to get married when I was happy with any situation that would arise - because I loved her, nothing was going to stop that (lasted darn near 20 years, loved her to the last second of the last minute, but she had other plans). We were lucky, both maintained good health along with 2 healthy girls - but I could always imagine the "what ifs".

Good health - poor health - rich - poor - yep, even death, it comes with us all.

Think positive man !