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Watchman FLX approved yesterday
Posted by Mac
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Watchman FLX approved yesterday July 22, 2020 02:21PM |
Registered: 6 years ago Posts: 35 |
Approved by the FDA yesterday.
My understanding is for insurance it requires a CHADS Score of 2, instead of 3 like the old one. I hope that’s true.
FLX approved
My understanding is for insurance it requires a CHADS Score of 2, instead of 3 like the old one. I hope that’s true.
FLX approved
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Re: Watchman FLX approved yesterday July 22, 2020 04:54PM |
Registered: 12 years ago Posts: 322 |
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Re: Watchman FLX approved yesterday July 22, 2020 11:33PM |
Admin Registered: 6 years ago Posts: 5,368 |
Quote
Mac
Approved by the FDA yesterday.
My understanding is for insurance it requires a CHADS Score of 2, instead of 3 like the old one. I hope that’s true.
That's great news about the approval. I had my last telemedicine interview with Rodney Horton, the lead researcher at TCAI a couple of days ago, and he indicated approval was imminent, but I didn't think it would be this soon.
I hope it's true too about insurance coverage but I think it will be a slow aceptance. The FLX is an incremental medical improvement, but not a game changer from a payer's point of view. They have to be convinced it costs less than long-term anticoagulants and strokes from non-compliance. There's already evidence showing that's true, but they're slow to change.
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Re: Watchman FLX approved yesterday July 23, 2020 10:39AM |
Registered: 4 years ago Posts: 783 |
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Re: Watchman FLX approved yesterday July 24, 2020 12:57AM |
Admin Registered: 6 years ago Posts: 5,368 |
Most insurance companies and Medicare aren't approving Watchman devices unless the patient meets strict requirements like having serious bleed risks, can't tolerate anticoagulants, has an emergency need, etc. I don't see the FLX itself changing that on its own. But I do think their thinking will come around in the near future, but that's going to take data that's not available yet.
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Re: Watchman FLX approved yesterday July 24, 2020 01:29AM |
Registered: 10 years ago Posts: 2,520 |
Carey- uneducated question-if one gets this implant which acts like a metal sieve to catch blood clots, what eventually happens to the collected blood clots? Do they accumulate in the fine mesh net until the screen mesh is clogged up with clots? I assume the purpose is to get off Eliquis- so one doesn’t have a blood thinner to dissolve the clots.
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Re: Watchman FLX approved yesterday July 24, 2020 11:10AM |
Admin Registered: 6 years ago Posts: 5,368 |
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susan.d
Carey- uneducated question-if one gets this implant which acts like a metal sieve to catch blood clots, what eventually happens to the collected blood clots? Do they accumulate in the fine mesh net until the screen mesh is clogged up with clots? I assume the purpose is to get off Eliquis- so one doesn’t have a blood thinner to dissolve the clots.
That's close but not quite how it works. The sieve isn't metal; it's fabric. The metal is only a skeleton that maintains the shape of the fabric and anchors the device in place. See this photo.
When it's in place the fabric sieve acts as a barrier that contains blood clots to within the LAA. The clots are much too large to get caught in the fine sieve. In fact, with no blood flow through the LAA, all the blood within it would quickly turn into one big clot. What happens is the endothelial tissue lining the interior of your heart grows over the device within about 6 weeks, permanently sealing the Watchman in place and sealing the LAA closed. What happens to the clots? The body eventually destroys them and reabsorbs them. In any case, it doesn't really matter what happens to them because they're confined to the LAA.
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Re: Watchman FLX approved yesterday July 24, 2020 11:44AM |
Registered: 10 years ago Posts: 2,520 |
Do you want blood flow through your LAA? I guess you do otherwise instead of a watchman they could surgically close off the LAA.
What kind of fabric? Do you know? Geese...now I have to get a fabric test. I have two coins currently taped to my leg to test for nickel reactions. A five cent nickel coin contains 75% copper, 25% nickel. It’s not reactive unlike 14K white gold rings or earrings which must contain more nickel because my skin starts blistering, ooze/pus. Last night I investigated international coins to find a coin with a higher nickel content. A one shekel coin is nickel plated. I now have a second shiny shekel also taped. Tomorrow my amazon package of a 100% nickel strip will arrive. That should conclude phase 1 testing. Then what was suggested was a watchman metal metal remnant implanted in my leg to be sure before it goes into my heart.
Now, thank you for the fabric info, I have to worry about the fabric. I’m allergic to stitches so I speculate the fabric maybe an issue if it contains silicone or nylon, catGut or any cotton content. Do you know what type of fabric it is?
What kind of fabric? Do you know? Geese...now I have to get a fabric test. I have two coins currently taped to my leg to test for nickel reactions. A five cent nickel coin contains 75% copper, 25% nickel. It’s not reactive unlike 14K white gold rings or earrings which must contain more nickel because my skin starts blistering, ooze/pus. Last night I investigated international coins to find a coin with a higher nickel content. A one shekel coin is nickel plated. I now have a second shiny shekel also taped. Tomorrow my amazon package of a 100% nickel strip will arrive. That should conclude phase 1 testing. Then what was suggested was a watchman metal metal remnant implanted in my leg to be sure before it goes into my heart.
Now, thank you for the fabric info, I have to worry about the fabric. I’m allergic to stitches so I speculate the fabric maybe an issue if it contains silicone or nylon, catGut or any cotton content. Do you know what type of fabric it is?
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Re: Watchman FLX approved yesterday July 24, 2020 11:51AM |
Registered: 10 years ago Posts: 2,520 |
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Re: Watchman FLX approved yesterday July 24, 2020 11:53AM |
Registered: 10 years ago Posts: 2,520 |
ADVERSE EVENTS
Potential adverse events (in alphabetical order) which may be associated with the use of a left atrial appendage closure device or implantation procedure include but are not limited to:
Air embolism, Airway trauma, Allergic reaction to contrast media/medications or device materials, Altered mental status, Anemia requiring transfusion, Anesthesia risks, Angina, Anoxic encephalopathy, Arrhythmias, Atrial septal defect, AV fistula, Bruising, hematoma or seroma, Cardiac perforation, Chest pain/discomfort, Confusion post procedure, Congestive heart failure, Contrast related nephropathy, Cranial bleed, Decreased hemoglobin, Deep vein thrombosis, Death, Device embolism, Device fracture, Device thrombosis, Edema, Excessive bleeding, Fever, Groin pain, Groin puncture bleed, Hematuria, Hemoptysis, Hypotension, Hypoxia, Improper wound healing, Inability to reposition, recapture, or retrieve the device, Infection / pneumonia, Interatrial septum thrombus, Intratracheal bleeding, Major bleeding requiring transfusion, Misplacement of the device / improper seal of the appendage / movement of device from appendage wall, Myocardia erosion, Nausea,
Oral bleeding, Pericardial effusion / tamponade, Pleural effusion, Prolonged bleeding from a laceration, Pseudoaneurysm, Pulmonary edema, Renal failure, Respiratory insufficiency / failure, Surgical removal of the device, Stroke – Ischemic , Stroke – Hemorrhagic, Systemic embolism, TEE complications (throat pain, bleeding, esophageal trauma), Thrombocytopenia, Thrombosis, Transient ischemic attack (TIA), Valvular damage, Vasovagal reactions.
So there is a possibility of material reaction.
Potential adverse events (in alphabetical order) which may be associated with the use of a left atrial appendage closure device or implantation procedure include but are not limited to:
Air embolism, Airway trauma, Allergic reaction to contrast media/medications or device materials, Altered mental status, Anemia requiring transfusion, Anesthesia risks, Angina, Anoxic encephalopathy, Arrhythmias, Atrial septal defect, AV fistula, Bruising, hematoma or seroma, Cardiac perforation, Chest pain/discomfort, Confusion post procedure, Congestive heart failure, Contrast related nephropathy, Cranial bleed, Decreased hemoglobin, Deep vein thrombosis, Death, Device embolism, Device fracture, Device thrombosis, Edema, Excessive bleeding, Fever, Groin pain, Groin puncture bleed, Hematuria, Hemoptysis, Hypotension, Hypoxia, Improper wound healing, Inability to reposition, recapture, or retrieve the device, Infection / pneumonia, Interatrial septum thrombus, Intratracheal bleeding, Major bleeding requiring transfusion, Misplacement of the device / improper seal of the appendage / movement of device from appendage wall, Myocardia erosion, Nausea,
Oral bleeding, Pericardial effusion / tamponade, Pleural effusion, Prolonged bleeding from a laceration, Pseudoaneurysm, Pulmonary edema, Renal failure, Respiratory insufficiency / failure, Surgical removal of the device, Stroke – Ischemic , Stroke – Hemorrhagic, Systemic embolism, TEE complications (throat pain, bleeding, esophageal trauma), Thrombocytopenia, Thrombosis, Transient ischemic attack (TIA), Valvular damage, Vasovagal reactions.
So there is a possibility of material reaction.
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Re: Watchman FLX approved yesterday July 24, 2020 08:26PM |
Admin Registered: 6 years ago Posts: 5,368 |
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susan.d
Do you want blood flow through your LAA? I guess you do otherwise instead of a watchman they could surgically close off the LAA.
No, absolutely not. My LAA is completely sealed off from blood flow now and has been for two years. That's the whole point. That fabric isn't intended as a filter that allows blood to keep flowing through it. It's a barrier to keep clots in the LAA until your endothelial tissue grows over it, completely sealing off the LAA. My LAA is now just an empty sack doing nothing whatsoever with absolutely no blood flow in or out.
Saying they could just surgically close it off is true, but that would mean a surgical procedure with much higher risks and weeks of recovery. Instead, my Watchman procedure lasted 20 minutes, involved a single femoral puncture, and recovery time was a whopping two hours. After the two hours of lying flat, I was sitting up, eating dinner, and then wandering down the hall to visit with my friend Andy who had the same procedure the same day.
Surgeons have been routinely excising and ligating the LAA when they do heart procedures for many years, but if you're not already doing heart surgery for some other reason, it would be nuts to choose surgery over a Watchman. I doubt most surgeons would even agree to do it.
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So there is a possibility of material reaction.
That possibility exists with virtually every invasive procedure there is, including things as simple as dental fillings.
As for the generic, all-encompassing list of adverse events associated with LAA occlusion devices you posted, I don't think such lists are at all helpful without providing the actual odds associated with each. And to be clear, the risk of everything on that list is eclipsed by the risk of driving to the hospital. Remember, there are hundreds of lurkers reading this forum who never post. Try to imagine yourself the scared newbie trying to find information about the Watchman and coming across a terrifying list like that with no indication what the risks really are.
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Re: Watchman FLX approved yesterday July 24, 2020 09:17PM |
Registered: 10 years ago Posts: 2,520 |
You are right Carey but it still can pose some issues to someone. Every drug lists side effects as well but that doesn’t stop those on Eliquis etc. One needs to make an informed decision. I like being transparent and know what risks are possible. Wouldn’t you want to see the list or are you ok with just jumping in to get the procedure?
Dodging covid19 at the cath lab’s waiting room where now visitors are allowed to wait and no policing of those who elect to take their masks off to moving the 6’ apart chairs to 2-3 feet apart so groups of visitors can chat and eat while they wait does have covid19 risks which frighten me more than the list.
Dodging covid19 at the cath lab’s waiting room where now visitors are allowed to wait and no policing of those who elect to take their masks off to moving the 6’ apart chairs to 2-3 feet apart so groups of visitors can chat and eat while they wait does have covid19 risks which frighten me more than the list.
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Carey
Do you want blood flow through your LAA? I guess you do otherwise instead of a watchman they could surgically close off the LAA.
No, absolutely not. My LAA is completely sealed off from blood flow now and has been for two years. That's the whole point. That fabric isn't intended as a filter that allows blood to keep flowing through it. It's a barrier to keep clots in the LAA until your endothelial tissue grows over it, completely sealing off the LAA. My LAA is now just an empty sack doing nothing whatsoever with absolutely no blood flow in or out.
Saying they could just surgically close it off is true, but that would mean a surgical procedure with much higher risks and weeks of recovery. Instead, my Watchman procedure lasted 20 minutes, involved a single femoral puncture, and recovery time was a whopping two hours. After the two hours of lying flat, I was sitting up, eating dinner, and then wandering down the hall to visit with my friend Andy who had the same procedure the same day.
Surgeons have been routinely excising and ligating the LAA when they do heart procedures for many years, but if you're not already doing heart surgery for some other reason, it would be nuts to choose surgery over a Watchman. I doubt most surgeons would even agree to do it.
So there is a possibility of material reaction.
That possibility exists with virtually every invasive procedure there is, including things as simple as dental fillings.
As for the generic, all-encompassing list of adverse events associated with LAA occlusion devices you posted, I don't think such lists are at all helpful without providing the actual odds associated with each. And to be clear, the risk of everything on that list is eclipsed by the risk of driving to the hospital. Remember, there are hundreds of lurkers reading this forum who never post. Try to imagine yourself the scared newbie trying to find information about the Watchman and coming across a terrifying list like that with no indication what the risks really are.
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Re: Watchman FLX approved yesterday July 26, 2020 05:56PM |
Registered: 6 years ago Posts: 35 |
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NotLyingAboutMyAfib
I've seen AN post on Twitter that BCBSTX won't approve current Watchman.
[twitter.com]
That’s a little troubling for those of us who had our LAAs ablated based on the Watchman being available.
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Re: Watchman FLX approved yesterday July 26, 2020 06:28PM |
Admin Registered: 6 years ago Posts: 5,368 |
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susan.d
You are right Carey but it still can pose some issues to someone. Every drug lists side effects as well but that doesn’t stop those on Eliquis etc. One needs to make an informed decision. I like being transparent and know what risks are possible. Wouldn’t you want to see the list or are you ok with just jumping in to get the procedure?
I've got no problem with posting a list of complications associated with a procedure. And I assure you I was well aware of all those risks before going into my first ablation. However, I had seen the risks broken down by the actual odds and knew that when you sum the odds of all those complications together you end up with about a 2% risk of complications, and that's across all EPs around the world, including the least experienced ones. With top EPs and top centers, the actual risk is well under 1%, and mostly they're minor complications such as bleeding at the insertion site.
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Re: Watchman FLX approved yesterday July 26, 2020 06:48PM |
Admin Registered: 6 years ago Posts: 5,368 |
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Mac
I've seen AN post on Twitter that BCBSTX won't approve current Watchman.
[twitter.com]
That’s a little troubling for those of us who had our LAAs ablated based on the Watchman being available.
Something's screwed up at BCBSTX. Almost all insurance companies follow the policies of Medicare, which are basically that they'll cover LAA occlusion devices but only as a "last resort." In general, Medicare and most insurance companies will cover the device if you can't tolerate any of the anticoagulants, you have a history of bleeds, you have a history of stroke/TIA despite anticoagulants, or it's on an emergent basis.
As I've said before, I think those policies will change in the near future as more data become available demonstrating that LAA occlusion devices are cheaper in the long run. Even when people can tolerate anticoagulants, the compliance rates are pretty dismal. Something like 40% of patients aren't compliant with their meds within just a few years, so stroke costs have to be factored in and the cost of those dwarf the cost of both the Watchman and long-term meds. (Well, unless the stroke is fatal in which case the insurance company wins.)
So in the end I think your insurance company will probably cover a Watchman within the next few years.
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Re: Watchman FLX approved yesterday July 29, 2020 03:51PM |
Registered: 6 years ago Posts: 35 |
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Re: Watchman FLX approved yesterday July 29, 2020 05:07PM |
Registered: 7 years ago Posts: 13 |
Carey, after your Watchman implant, did you notice any difference in your energy level or endurance? I recall reading somewhere that because closure of LAA results in slightly less blood volume getting pumped to the body by the left atria, that could impact energy level or endurance. If one is considering getting the Watchman (like me), it would be good to know if closure of the LAA might affect one's energy level or endurance, or anything else. Thanks!
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Re: Watchman FLX approved yesterday July 30, 2020 01:14AM |
Admin Registered: 6 years ago Posts: 5,368 |
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tmac52
Carey, after your Watchman implant, did you notice any difference in your energy level or endurance? I recall reading somewhere that because closure of LAA results in slightly less blood volume getting pumped to the body by the left atria, that could impact energy level or endurance. If one is considering getting the Watchman (like me), it would be good to know if closure of the LAA might affect one's energy level or endurance, or anything else. Thanks!
You've actually got two questions here, so I'll take them separately.
#1 - Does LAA isolation during an ablation reduce cardiac output? Maybe, but it would be minimal and it's not really the LAA isolation. Any ablation involving the left atrium can reduce what's known as the "atrial kick." That's the small percentage of added blood volume added to each beat by the left atrium contracting strongly. Any ablation can weaken that contraction and therefore the "kick." Personally, I never noticed a change and I've undergone multiple ablations and have a greatly reduced atrial kick because of them, but it just hasn't ever been something I noticed (unlike afib and flutter -- oh hell yeah I noticed those in the low energy and endurance departments).
#2 - Did the Watchman device affect my energy or endurance? No, the Watchman had absolutely no effect on my energy level or endurance whatsoever. I've been completely unaware of its existence for two years now. I always wear a chest strap heart monitor while cycling and so I know what my heart rates should be on certain hills. That lets me judge my fitness levels pretty accurately. The Watchman made no difference.
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Re: Watchman FLX approved yesterday July 30, 2020 03:24PM |
Registered: 7 years ago Posts: 13 |
Thanks Carey. I too am a cycler. It's good to hear that the Watchman hasn't affected your hill climbing.
One of several reasons I will be getting the Watchman is to lessen the risk of bleeding should I ever crash on the bike, or fall and hit a rock while hiking. I hope to get off Eliquis with the Watchman, like most patients have.
One of several reasons I will be getting the Watchman is to lessen the risk of bleeding should I ever crash on the bike, or fall and hit a rock while hiking. I hope to get off Eliquis with the Watchman, like most patients have.
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Re: Watchman FLX approved yesterday July 30, 2020 04:42PM |
Registered: 12 years ago Posts: 322 |
My experience tallies with Carey's. I haven't noticed any reduction in energy or endurance since having my Watchman FLX installed in Sept. 2018. As Carey suggested, I remember that it was implanted, but otherwise I'm not aware that it's there. There's no sensation, and certainly no ill-effects thus far.
All best wishes,
Lance
Edited 1 time(s). Last edit at 07/30/2020 07:03PM by ln108.
All best wishes,
Lance
Edited 1 time(s). Last edit at 07/30/2020 07:03PM by ln108.
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Re: Watchman FLX approved yesterday January 23, 2021 02:25PM |
Registered: 5 years ago Posts: 5 |
Hi Lance, I haven't been on this Forum since 2018. But after having an Ablation that worked for almost 2 years and a Cardioversion that worked for six months, I'm now back in A-Fib and having to take Eliquis and it is causing me terrible side effects,...It's making me very weak and unable to do much of anything without getting out of breath, etc., so I'm considering having the Watchman installed so I can get off of it...but I wasn't aware there are different types of the Watchman. Should I ask my doctor for the FLX? Are they available everywhere?
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Re: Watchman FLX approved yesterday January 23, 2021 08:20PM |
Registered: 12 years ago Posts: 322 |
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Sunny82
Hi Lance, I haven't been on this Forum since 2018. But after having an Ablation that worked for almost 2 years and a Cardioversion that worked for six months, I'm now back in A-Fib and having to take Eliquis and it is causing me terrible side effects,...It's making me very weak and unable to do much of anything without getting out of breath, etc., so I'm considering having the Watchman installed so I can get off of it...but I wasn't aware there are different types of the Watchman. Should I ask my doctor for the FLX? Are they available everywhere?
Sunny,
I'm sorry to hear of your current situation. Shannon and Carey would know more, but my expectation would be that the original Watchman has now been replaced by the Watchman FLX. I know that Dr. Natale believes it is superior in many respects to the original Watchman. If you're cardiologist doesn't know about all this, I'd look for another cardiologist.
I know also that the advice on this forum has always been to get this kind of thing done by an experienced operator who has a record of many, many successful procedures. You could ask the elders on this board for recommendations, depending on your location.
Best wishes, Lance
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