Watchman Pinnacle FLX 12 month findings

So the not so shiny new Watchman FLX I was fortunate enough to have implanted as part of the Pinnacle clinical trial recently released their 12 month findings. Mine was implanted about 21 months ago.

More info here:

[www.tctmd.com]

They used Watchman v2.5 as the baseline for comparison, and the numbers look fantastic from my layman’s eyes.

Nice to know!

(Wish this site had a like button.)

Hello everyone on this great forum. My name is Salwa Beheiry. I work in Austin TX.
I am glad that some of you on this forum have had experience with the new Flex. During the study and by watching the implant procedure in our labs, I have had and intuition that this device would be so much easier to implant with a relatively higher success rate. Only time will tell but the data after 12 months looks very promising!
Anyone one else on this forum has the experience of any other closure devices?
Cheers,
Salwa

Hi Salwa, welcome to the forum. There are three people here who received the Watchman FLX (myself, AB Page, above, and Robbie), but the only person I know of who's received another type of closure device is Shannon.

Thank you Carey! It would good to compare experiences from different people.

Welcome Salwa!!

For all our forum folks, Salwa is a very dear long time friend of mine going way back to the early 2000's when Dr Natale first started doing cases at Marin Hospital in Marin county in the SF Bay Area, and she has been literally the right hand arm of Dr Natale going WAY back to I believe his time at Duke Univ. Med, even before California right Salwa??

Salwa knows all about my AFIB journey, including my LARIAT LAA ligation before the Watchman was approved, she has been a real Guardian angel to me at times throughout my long AFIB saga as well, including when she jumped on the phone from California all the way to Amsterdam 16 years ago during my four year stay in Holland late in the a summer Dutch evening time when I was about to have my first Electro-cardioversion's (my first of 16 total ECVs) back in the day when I was still dealing with the beast.

Salwa took charge of the Dutch Docs insuring they knew my history and thus reassuring me greatly that I had an ally right there by my side at the time!

And we have had a lots of fun at the many EP-related conferences all over the US over they past 10 years with Dr Natale, Luigi DiBiase, Pasquale Santangeli, DJ Lakkireddy and many other of our dear EP friends.

Salwa was the Director for many years of Dr Natale’s SF clinic at Calfornia Pacific Medical Center in San Fran where Dr Natale did ablations one week out of each month there for well over 17 years if my memory is correct ...

Salwa most recently came to Austin to oversee the construction and launching on behalf of Dr Natale of the fabulous brand new state of the art EP Center at St David's Medical Center!

So glad to see you back on the forum Salwa!

Big Hugs,
Shannon



Edited 1 time(s). Last edit at 05/20/2020 04:58PM by Shannon.

What watchman does Dr Natale use?

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capitana1952
Hello everyone on this great forum. My name is Salwa Beheiry.
Cheers,
Salwa

Nice to meet you Salwa, and thank you for being part of Dr. Natale’s team over the years, and for your work that ultimately contributed to my and many others successful outcomes as patients. Everyone at TCAI/St David’s is pretty dang amazing. And that new wing I had the pleasure of touring with Carey and some Boston Scientific people was incredible.

Andy

Outside of a clinical trial, I think he would use the most current legally permitted, what I see referred to, I believe, as v 2.5

6.6% deaths

Hello Everyone I was also in the Watchman Flex Trial At the twelve month mark I still still has a small leak Less than 5MM A Ring Enclosure device was inserted to close off the the leak . After 2 months A TEE was performed and the leak was sealed off. Everything went well only on a Baby Asprin know

All is Good
Brent

I Have had the original Watchman for 10 months now.
The two TEEs I had showed no leaks. Will be doing the 12 month TEE On schedule hopefully.
On baby Aspirin.
One thing that concerns me is endothelialization. Or the lack there of for some.

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susan.d
6.6% deaths

WHAT? Where are you getting that number from?

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Carey

6.6% deaths

WHAT? Where are you getting that number from?

D-PO01-036 - Histologic Failure To Endothelialize Watchman And Watchman FLX LAAO Devices At Autopsy (ID 55)

[cslide-us.ctimeetingtech.com]

Quote
gmperf
D-PO01-036 - Histologic Failure To Endothelialize Watchman And Watchman FLX LAAO Devices At Autopsy (ID 55)

[cslide-us.ctimeetingtech.com]

That's kind of meaningless since it was only 3 patients.

There is NOT a 6.6% death rate associated with the Watchman device. There's no way it would have been approved by the FDA or in Europe if it had that kind of risk. There's no way I would have gotten anywhere near it if that were even remotely true.

Quote
Carey

6.6% deaths

WHAT? Where are you getting that number from?

AB Page link shared:

In terms of adjudicated clinical outcomes at 1 year, there was a 6.6% rate of all-cause death, a 4.4% rate of CV/unknown death, and a 2.6% rate of stroke, all ischemic. Pericardial effusions were recorded in four patients (1.0%); all required pericardiocentesis or pericardial puncture. Major bleeding (BARC 3 or 5) was seen in 7.9%.

Quote
susan.d
there was a 6.6% rate of all-cause death

Okay, now I understand where you got that number. It includes all the people who died regardless of cause. Most of those people would have died whether they had a Watchman or not. The death rate associated with the Watchman device is far below 1%. Please be careful when interpreting study results. It's easy to misinterpret them.