Receiving the Watchman FLX - impressions and experience

I wanted to create a thread on my Watchman FLX that was implanted by Dr. Natale and Horton at St. David’s this past Thursday, and answer any questions anyone might have about my experience.

While there I also had the pleasure of meeting fellow forum members Jerry and Carey. All of our consultations were essentially back to back, so it was quite the gathering inside the TCAI waiting area. My consultation included visits by NP Curry, Watchman nurse Annie and at least 2 folks from the research arm of TCAI. I signed some forms that were required for the trial that enabled me to participate in this and receive the latest generation Watchman FLX.

Immediately prior to the consultation was a really quick TTE inside the cardiology area in St David’s.

While I was meeting with Curry the scheduler called with my 7:00 report time on Thursday.

When I reported Thursday, the world-class health care system that is TCAI and St David’s kicked in. After getting in my room in cardiology prep I had the IV put in as well as the various other things they do, like weigh you and place individual stickers on your overnight bag and in my case, my sleep machine.

I believe I was 2nd in line, after Jerry and before Carey. Before being taken upstairs, I was visited by TCAI manager Carlos, who updated me on the status of everything and expected timeframe, which was pretty accurate. Carlos is just great, as was the TCAI nurse who visited with a few more papers to sign and then before I knew it I was taken upstairs to the 2nd floor just outside the lab where I waited and observed the amazing orchestrated team moving about the hallways. At one point Dr. Natale came out of the lab to reassure me and let me know it would just be a couple more minutes as they finished turning the lab around. My final visit before being wheeled in to the lab came from anesthesiologist Dr. Allen, an extremely pleasant and professional doctor that I liked a lot. We talked a little, then a man and woman got me in the lab and talked to me the whole time while I was transferred to the table and prepped. I can’t overstate enough how wonderful the staff are at making you comfortable and at ease. Last time I was in this situation I was in pretty high rate flutter, but now I was more relaxed and kind of took in the cool and amazing technology inside the lab. When I laid back, maybe 5 minutes later, Dr. Allen loosely placed the mask over my nose and mouth and the propafol started in my veins ( I think). Next thing I knew I was waking up in recovery.

Because they are now using the collagen plugs, technically the VASCADE Vascular Closure System from Cardiva Medical, the time laying flat is reduced to just a couple of hours. Also, this time the sheaths at the insertion site were already removed so I had no pain, just a tenderness in the groin area.

The procedure took just about an hour, including the TEE that is done just prior for proper Watchman sizing and other critical imaging. I was told I received the 20mm version, which I think is the smallest size. In recovery, I was given ice chips followed by a pudding. There was no pain whatsoever, and because I was only under a short time, I woke up fully quite fast. Very soon I was elevated a little bit. I had 2 wonderful recovery nurses in my area that checked the insertion site a few times, and that only produced mild discomfort. I couldn’t believe how fast the morning had gone and how great I felt.

When my room was ready a short time later (thank you Shannon for the VIP room!), I was wheeled in and the St. David’s nurses and techs took over. Each was extremely kind and professional. I was in shock that I now had a device implanted inside my heart that would protect me from strokes due to clots in my electrically isolated left atrial appendage and I couldn’t even tell anything had been done to me. The only sign was the tender insertion sites in the groin area. By Friday morning I managed a few hours sleep despite the regular visits for vital checking etc. Dr. Natale stopped in Friday morning very briefly, and NP Carrie, nurse Annie and at least one other TCAI nurse stayed and went over things with me. I felt great if not a little tired. My heart rate was great and I noticed zero ectopic beats. I’ve since had maybe a handful but that’s it. My resting rate is just maybe 5bpm faster than where it was as my heart starts the healing process and welcomes it’s new addition. The food here is excellent. Thursday evening I had the salmon with wild rice and grilled asparagus, and strawberry shortcake for dessert.

7-10 days of no lifting over 10lbs and just plain common sense taking it easy and I’ll ease back into my normal routine. I return in 6 weeks for a TEE to be sure there aren’t any leaks and that endothelial tissue is growing over the parachute like device and thereby providing the stroke protection. I’m taking Eliquis and low dose aspirin daily, and if the TEE shows the expected tissue, I’ll be transitioned to Plavix and low dose aspirin for 4.5 months before stopping all NOAC and anti-platelets, which of course is the reason this was done.

I can’t emphasize enough how easy this procedure has been on me, and if you are in a position to possibly choose to have this device implanted, I think it’s probably a no-brainer. I’ll be flying home tomorrow and am wishing Jerry and Carey the best as they continue on this journey too. As always, I owe such a great deal to Shannon, Dr. Natale and the first-rate staff of professionals at TCAI and St. David’s Medical Center in Austin.

So glad to hear everything went well for you. TCA and St David's are top notch. Your experience mirrors mine for my ablation.

I wish I could remember
Everyone's name that was encountered that day. But I do remember Carlos. What a comforting soul he is.

The salmon was delicious.



Edited 1 time(s). Last edit at 08/04/2018 09:13PM by rocketritch.

I told Carlos afterward I wished I could personally thank the 2 in the lab itself and he brought them to my room! They appeared very grateful, almost shocked when I shared with them how comfortable and calm they made me. And that each and everyone of them whether I saw them in person or not, have a positive effect on my health and that they should feel good everyday when they walk out the door.

OK Page, I have a question about the study.

What did the team from TCAI tell you ?
What stands out in the forms from TCAI that would be worth mentioning ?
What was the final form from TCAI that came just before your procedure ?

The main question I have is the difference in what has to be done following the procedure when involved in the study as apposed to the same procedure being paid for from private insurance or medicare.

Also, did you have a ct scan before, and will you have to have one in the future due to being part of the FLX study.

A very good report and I thank you for posting it. I am in the process of talking to them about being included in the study. I think it could happen, but I am having some second thoughts about the study itself and also am wondering if a little more time should be allowed for the new watchman to be observed a little while longer. I have been on thinners for 12 years and have no problems with the Eliquis.

Best of luck to you in future.

...ron H.

Hi Ron,

I was helped through this process by Shannon, and his communications with Dr. Natale, as well as my own research. The study folks are/were looking for men to join a somewhat lopsided weighted female population. It seems to be widely accepted in the community that this version of the FLX is much improved over the one voluntarily pulled from the prior most recent European trial. Improvements include more sizing options for different sized ostium, a center head that isn’t as “screw-like” as the previous and is more recessed, and more anchors for locking it in place. Also, it isn’t as tall.

The paperwork supplied by TCAI and Boston Scientific in conjunction with the governing body, for lack of a better term, seems pretty standard, including mentioning of every bad outcome possible. Having never participated in a clinical trial, I have nothing to compare it to. Procedural complications are very low, especially when attended to by Drs. Natale and Horton.

I am allowed to withdrawal at any time but would forfeit any further medical care provided for and paid for by the study. I will return to TCAI in 6 weeks for a TEE. Assuming the device has endothelialised and has no leaks greater than 5mm, I will switch regimen, and return again at 6, 12, and 24 month intervals, I believe for TEE’s. No CT but they might have referenced my prior CT in last year. Any care needed due to complications from the device I believe is covered, and of course everyone is released from liability. Travel reimbursement is limited to $80 per visit.

In short, I believe we’re helping establish the routine post procedure care and med schedule for eventual FDA clearance and acceptance and new patients, so unless something unexpected occurs among a significant number of participants, I believe that as an insurance paid patient you could expect similar follow-ups. Carey will probably add from his perspective at some point also.

You've covered it so well I can't think of anything to add.

Deb and I are back home now and I must say that my experience with the Watchman FLX was very similar to Andy's except for the Salmon, ( I had the Beef Tenderloin!). It's the calibre of the people on staff at TCAI/St. Davids that makes it such a special place. After having 2 ablations by Dr. Natale at St. Davids I had absolutely no anxiety about this procedure. I feel as Andy described, if it wasn't for the slightly tender catheter insertion site I wouldn't realize that anything was done. I am happy I had the chance to meet Andy and Carey and hope to rendezvous in September when we go back for our 6 week TEEs.


Jerry

Thanks to all who participated. Who pays, Boston Scientific?

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jpeters
Thanks to all who participated. Who pays, Boston Scientific?

Yes. They only reimburse $80 per trip for travel, but they pay for everything else.

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Carey

Thanks to all who participated. Who pays, Boston Scientific?

Yes. They only reimburse $80 per trip for travel, but they pay for everything else.

Two interesting related news bits:

"The 2-year suspension of the medical device tax by U.S. House and Senate, starting January 2018, has also provided temporary relief to the company, allowing it to make resources available for its future R&D programs."

"Boston Scientific has emerged as one of the leading players in Rhythmia and Electrophysiology business."

Hope this works out well. I remember all the problems they went through with the stent recalls in 2004, which took over 9 years to recover from.



Edited 1 time(s). Last edit at 08/05/2018 01:44AM by jpeters.

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jpeters
"The 2-year suspension of the medical device tax by U.S. House and Senate, starting January 2018, has also provided temporary relief to the company, allowing it to make resources available for its future R&D programs."
.

The medical device tax was one of the worst things to come out of the ACA. It was both stifling and costly to both the medical device industry and the consumer.

The amounts of money, mostly privately funded,is astronomical to bring a device to market



Edited 1 time(s). Last edit at 08/05/2018 03:38PM by rocketritch.

Many thanks, AB, for this fine report.

--Lance

I hope everything goes well for all in this trial test. Why are they having this trial test now when the Watchman has been on the market and implanted in people. Is the device made out of different material, I have read about the dangers of the polypropylene meshes that were used which caused problems. I have thought about having the watchman but still iffy.

Liz

Hmmm. Now that Liz mentions it, I'm clear that Natale and colleagues recommend the Watchman FLX whole heartedly and without reservation. However, what I'm not clear on is whether it is fully FDA approved and covered by insurance outside of trials such as this one at Austin that a number of this group has been fortunate to participate in.

Input appreciated!

--Lance

Looks like it's still a work in progress, as Boston Scientific is collecting more data from various centers. It was initially withdrawn in 2016 "after higher-than-anticipated device embolization rate of 3.8%", but Natale obviously feels the uncertainties have been worked out.

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ln108
Hmmm. Now that Liz mentions it, I'm clear that Natale and colleagues recommend the Watchman FLX whole heartedly and without reservation. However, what I'm not clear on is whether it is fully FDA approved and covered by insurance outside of trials such as this one at Austin that a number of this group has been fortunate to participate in.

The original Watchman is FDA approved and covered by insurance*, but the FLX is not. It's available only to participants in the clinical trial at this time.

* At this time, any version of the Watchman is only covered by Medicare and most private insurance companies if you cannot tolerate anticoagulants. I think that will change in the next few years as insurance companies calculate the cost of strokes vs. the cost of the procedure, but so far they consider it a last-resort option only so don't expect your insurance company to approve one just because you want it.

To answer Elizabeth's question: The FLX has several design changes, which means it needs separate FDA approval. Hence, the clinical trial.

I thought the reason for the second trial of this device was because the original study was heavily weighted on the female persuation. And that this trial would be mostly or entirely men.

So far as it being done in several different locations would be due to random data collection required by the FDA and or including the European equivalent (EMA) .

I'm not sure as to how many implantations would be required for a second trial, but it could be in the hundreds.

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rocketritch
I thought the reason for the second trial of this device was because the original study was heavily weighted on the female persuation. And that this trial would be mostly or entirely men.

So far as it being done in several different locations would be due to random data collection required by the FDA and or including the European equivalent (EMA) .

I'm not sure as to how many implantations would be required for a second trial, but it could be in the hundreds.

Your understanding is correct. This trial is only open to men because previous trials were too heavily weighted with women. It's being offered in 10 centers with a total of 490 devices available for the trial.

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Carey



Your understanding is correct. This trial is only open to men because previous trials were too heavily weighted with women. It's being offered in 10 centers with a total of 490 devices available for the trial.

It's not hard to see why the BSX is trading at a PE of 413.95 and EPS of .08. Success amounts to hoping that the latest round of tests shows much lower embolization rate than before the recall, approval by the FDA, and then acceptance by the insurance industry....and if they need to change anything, repeat.... Think I'll stick with consumer staples.



Edited 1 time(s). Last edit at 08/06/2018 01:47AM by jpeters.

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jpeters
It's not hard to see why the BSX is trading at a PE of 413.95 and EPS of .08. Success amounts to hoping that the latest round of tests shows much lower embolization rate than before the recall, approval by the FDA, and then acceptance by the insurance industry....and if they need to change anything, repeat.... Think I'll stick with consumer staples.

The medical implant industry is very volatile. I'm not sure what the percentage of devices that make it to med trial evaluation to those that get tanked before they even get there is but I would wager the difference is in the range of 80/20 in favor of those getting tanked

Its a tough industry at best

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rocketritch


The medical implant industry is very volatile. I'm not sure what the percentage of devices that make it to med trial evaluation to those that get tanked before they even get there is but I would wager the difference is in the range of 80/20 in favor of those getting tanked

Its a tough industry at best

And then some unknown comes up after they're approved, requiring a recall, and the process starts all over again. They need to be subsidized, not taxed.

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jpeters
And then some unknown comes up after they're approved, requiring a recall, and the process starts all over again. They need to be subsidized, not taxed.

Normally I would agree with your subsidizing statement. But having worked in the field for many years I saw products that were both subsidized either directly by government (DARPA) or through research grants. This was actually the bulk of what we did. We also dealt with private researchers as well.

I will say that the private side of our business moved along at a much higher pace that that of the subsidized. I saw the reason for the lackluster pace of the subsidized research as being two fold. FIrst was where the money was coming from. The accountability just was not there like it was for the private industry. Secondly was that much time was spent writing grants to keep the project running. And of course those writing the grants were the main researchers so there was always several months of stagnation every year during the grant writing and application process.

Probably the best way to subsidize private industry would be to do it through tax relief. both for the company and investors.



Edited 1 time(s). Last edit at 08/17/2018 08:30PM by rocketritch.

I have never heard about this free trial by Boston Scientific until now. I have had 2 Ablations with Dr. Natale, The last in June 2016. I am on a blood thinner for life and hate it.
How did you individuals find out about this? You must know someone.

smackman,
I just got an info from Dr. Rendall Wolf. He claims that his minimally invasive LAA ectomy is covered by most insurances. Not sure how he achieves that but may be an option for you. Yes it is a surgery but hey it may be a small price to pay for getting rid of AC. Try talking to him(call 877-900-2342) because I would be also interested if I have my LAA ablated. I will have second procedure with Dr Natale August 29. My first one with him was March 2008 (10 years ago).



Edited 4 time(s). Last edit at 08/07/2018 11:19AM by dartisskis.

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dartisskis
I will have second procedure with Dr Natale August 29. My first one with him was March 2008 (10 years ago).

Very best to you on the 29th.

AB Page,
Thanks a lot. I certainly hope that my touch up will not include LAA. Since March i had just 3 episodes and they were relatively short ( 1.5 to 2 hours) but i am often in remote areas fishing and also kayaking in white water. It is not fun to have an episode while crossing some rapids. So I decided that it is time to act again and Dr. Natale agreed.

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smackman
I have never heard about this free trial by Boston Scientific until now. I have had 2 Ablations with Dr. Natale, The last in June 2016. I am on a blood thinner for life and hate it.
How did you individuals find out about this? You must know someone.

I learned of it when I attended HRS2018 and met Dr. Horton, the study director. If you're interested, just call TCAI and ask about it. You'll have to be a CHADS-Vasc 2 or higher to qualify.

Thanks for the answers. Where I live I have no inside scoop to big Institutions, Hospitals etc. I live deep in the country in North Central Louisiana. We pipe sunshine down here 🤣.
Hopefully one day I will get lucky. I love NSR but despise anticoagulants. I have been on first Pradaxa then Xarelto then Eliquis back to Xarelto and currently Eliquis. All these brand name AC are expensive and puts me in the loop hole every year. I have had to change between Xarelto and Eliquis because the Tier level can change from year to year.
Also, I wants see some more “run time” on these devices.
Anyway, Life is good.

I had my 45 day...ok technically 40 day follow-up TEE this morning and the imaging showed it to be anchored properly and no leaks. Great news!

I will start clopidogrel and stop Eliquis when I return home, as well as continue the low dose aspirin. Dr. Natale seems to believe that Eliquis would be the better choice, but this is a study, so I will make the switch, until the six month mark in very early February, when the next follow-up will be. They weren’t certain if another TEE is required, but even if not, I think I would still like to have one as I am pretty conservative. Still can’t say enough good things about all the folks at St. David’s and TCAI. A big thanks to Shannon as well!

I asked Dr. Natale about early data and what they are seeing, and he said it looks really, really good so far, in fact no device related thrombus (thrombi?). Not sure if that is just St. David’s or for every participating site.

Congrats, AB. Great news! I recall that others in this group are up for their follow-up TEEs soon as well. Good luck to them also.. Looking forward to hearing their reports.

Does anyone how know many people have actually received the Watchman FLX so far? I'm scheduled for one toward the end of this month in San Diego. My wife is concerned that I'm serving as a "guinea pig," so I'm looking for information to allay her worries.

Thanks

--Lance

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AB Page
I had my 45 day...ok technically 40 day follow-up TEE this morning and the imaging showed it to be anchored properly and no leaks. Great news!

I will start clopidogrel and stop Eliquis when I return home, as well as continue the low dose aspirin. Dr. Natale seems to believe that Eliquis would be the better choice, but this is a study, so I will make the switch, until the six month mark in very early February, when the next follow-up will be. They weren’t certain if another TEE is required, but even if not, I think I would still like to have one as I am pretty conservative. Still can’t say enough good things about all the folks at St. David’s and TCAI. A big thanks to Shannon as well!

I asked Dr. Natale about early data and what they are seeing, and he said it looks really, really good so far, in fact no device related thrombus (thrombi?). Not sure if that is just St. David’s or for every participating site.

Great news. Thanks for the update