My mother had the Abbott Amulet device implanted for AFib on 10/21/2024 (despite tolerating Eloquis well). It embolized while she was in the recovery unit and was eventually retrieved from her mitral valve. As a result, she suffered multiple bilateral strokes leaving her blind and virtually non-responsive - basically in a coma. That was just the beginning of the nightmare. The medical system let her and us down repeatedly. She died not quite 2 months later in an ICU a week after being discharged, against our appeals, from an LTACH into a nursing home. The cause of death was Septic Shock complicated by Hypoxemic Respiratory Failure, complicated by Stage 4 Sacral Decubitus Ulcer, complicated by Malnutrition. Please, if any patients or their families are considering this procedure, beware of the risks and how you and your family will be treated if it fails.
This saga has been one of the more egregious examples of regulatory incompetence during the course of my practice thus far.
And the only times I’ve referred have been for people who absolutely can’t/won’t take OAC due to previous life threatening bleeding….which of course is a completely evidence free zone for this device but at least it’s for people with no viable options.
For people who might want an LAAO device simply to forego the inconvenience of OAC, I ask them how inconvenient they think a 5x increase risk of stroke might be instead.
Dr. Mandrola is always a pleasure to read. I think similar issues might be in play with the “flozins” being so heavily promoted to the cardiloogy community.
Torturing data for profit with the suffering of vulnerable patients at stake is a head scratcher?
Here’s another head scratcher:
My company just got approval to make car airbags that are more difficult and dangerous to install BUT are just as good as the airbags from the 1990’s (as long as you ignore the 60 minutes directly after the car crash).
Side issue you mentioned was warfarin vs DOAC's. I still prefer warfarin for myself. It's clinically proven over many years and works well enough, especially since I am uncomfortable with supporting the massive profits of DOAC's. For stable patients monitoring INR's can be every 4 months.
Thank you. I was pointing out that while the scientific back-up to the conclusion is important, the conclusion gets lost in the detail. Therefore, readers like me might not continue to the end.
Here is one explanation. The FDA is a typical government regulatory agency populated with individuals that spend their entire careers passing through the revolving doors between industry and government.
Just look at the raw percentage differences and ignore the statistical stuff. Then go out and ask the first ten people you see whether they would like to have an invasive procedure or take anticoagulant medicine for life in order to reduce their risk of stroke from 2.0% to 1.5% over a five year period. Most of these studies compare different medications and/or medical devices or procedures. They rarely include a control group that takes no treatment. That would reveal that none of these medications or devices provide any real preventive value.
It is worth mentioning that in the real world, the decision is not warfarin vs LAAO or even DOAC vs LAAO. It is LAAO vs nothing. The patient referred for LAAO in my practice has had a major bleeding event or a major fall sustaining head or gruesome face injuries. They can be persuaded to take aspirin and clopidogrel for 6 months further typically, but refuse further lifelong anticoagulation.
How would LAAO fare compared with nothing in a trial? I understand the rationale for warfarin vs LAAO but that is the decision most clinicians face.
To me this is *the* question. Pts who get LAAO have to accept an upfront procedural risk. Real world data put it at 5%. Maybe it’s lower at expert centers. Then they incur a 3-7% risk of device thrombus—which is terrible b/c stroke risk goes up 4-fold. And they have to take anticoagulant.
So, to me, nothing starts w a huge lead over LAAO in such patients. And. LAAO vs nothing in older pts w bleeds is exact the trial that should be done.
This is outside of my field — nutrition, biochemistry — but my understanding from similar discussion on stents is that if you do not use the procedure, there is potential legal questions of whether patient was offered best treatment. It seems that there should be some agency that can define standards for patients’ informed consent. Possibly bigger than this venue but What is the state of that issue?
I think an agency (presumably governmental) that defined standards for informed consent would create a mess that only lawyers would love. I always advised patients to get second and third opinions on any potentially serious medical issue.
A friend in his early 70s with a history of heart attack and now AFib was using Eliquis but not enjoying the side effects. He also has a defibrillator and lives in fear of the damned thing going off and knocking him on his butt. Well, a nosebleed convinced him he couldn't tolerate the blood thinner so his doctor told him he was eligible for a Watchman, even though cauterization fixed the bleeding. I have been reading your articles here on the Watchman and watched your YouTube presentation on it. I sent the links to my friend. He read/watched and three weeks ago went ahead and got the LAAO with the Watchman.
The doc told him they no longer need to use Plavix post procedure. But he is on Eliquis again for a while. I am just a friend but am concerned for him. I did want to thank you, Dr Mandrola, for at least providing a counterpoint to the happy sales pitches for this device.
On your asterisk--knowing relative vs absolute is important, and also knowing that's the ABCs of establishing a successful trial, it strikes me as odd for the FDA tilts the playing field (if im reading right). They establish a risk ratio, sensible, but then use absolute numbers that are not anchored to the a priori marker of efficacy--as in your illustrative 20/18 example above. Whats the rationale there from FDA side. How do they justify their decision?
My mother had the Abbott Amulet device implanted for AFib on 10/21/2024 (despite tolerating Eloquis well). It embolized while she was in the recovery unit and was eventually retrieved from her mitral valve. As a result, she suffered multiple bilateral strokes leaving her blind and virtually non-responsive - basically in a coma. That was just the beginning of the nightmare. The medical system let her and us down repeatedly. She died not quite 2 months later in an ICU a week after being discharged, against our appeals, from an LTACH into a nursing home. The cause of death was Septic Shock complicated by Hypoxemic Respiratory Failure, complicated by Stage 4 Sacral Decubitus Ulcer, complicated by Malnutrition. Please, if any patients or their families are considering this procedure, beware of the risks and how you and your family will be treated if it fails.
This saga has been one of the more egregious examples of regulatory incompetence during the course of my practice thus far.
And the only times I’ve referred have been for people who absolutely can’t/won’t take OAC due to previous life threatening bleeding….which of course is a completely evidence free zone for this device but at least it’s for people with no viable options.
For people who might want an LAAO device simply to forego the inconvenience of OAC, I ask them how inconvenient they think a 5x increase risk of stroke might be instead.
Dr. Mandrola is always a pleasure to read. I think similar issues might be in play with the “flozins” being so heavily promoted to the cardiloogy community.
Excellent review.
But “Head scratcher”?
Torturing data for profit with the suffering of vulnerable patients at stake is a head scratcher?
Here’s another head scratcher:
My company just got approval to make car airbags that are more difficult and dangerous to install BUT are just as good as the airbags from the 1990’s (as long as you ignore the 60 minutes directly after the car crash).
Side issue you mentioned was warfarin vs DOAC's. I still prefer warfarin for myself. It's clinically proven over many years and works well enough, especially since I am uncomfortable with supporting the massive profits of DOAC's. For stable patients monitoring INR's can be every 4 months.
Taking out a week after the procedure is like taking out two weeks after a vaccination. And obviously no one would ever do something so stupid.
I felt stupid. However, I agree with you.
There have been no randomized trials in patients deemed ineligible for long-term oral anticoagulation."
So what do you advise in this all too common situations?
Oh now I see your comment
Thanks
Thank you. I was pointing out that while the scientific back-up to the conclusion is important, the conclusion gets lost in the detail. Therefore, readers like me might not continue to the end.
Here is one explanation. The FDA is a typical government regulatory agency populated with individuals that spend their entire careers passing through the revolving doors between industry and government.
This needs to be dummied down for people like me.
Perhaps not “dummied down” but translated into lay language for the curious mortal.
Just look at the raw percentage differences and ignore the statistical stuff. Then go out and ask the first ten people you see whether they would like to have an invasive procedure or take anticoagulant medicine for life in order to reduce their risk of stroke from 2.0% to 1.5% over a five year period. Most of these studies compare different medications and/or medical devices or procedures. They rarely include a control group that takes no treatment. That would reveal that none of these medications or devices provide any real preventive value.
It is worth mentioning that in the real world, the decision is not warfarin vs LAAO or even DOAC vs LAAO. It is LAAO vs nothing. The patient referred for LAAO in my practice has had a major bleeding event or a major fall sustaining head or gruesome face injuries. They can be persuaded to take aspirin and clopidogrel for 6 months further typically, but refuse further lifelong anticoagulation.
How would LAAO fare compared with nothing in a trial? I understand the rationale for warfarin vs LAAO but that is the decision most clinicians face.
To me this is *the* question. Pts who get LAAO have to accept an upfront procedural risk. Real world data put it at 5%. Maybe it’s lower at expert centers. Then they incur a 3-7% risk of device thrombus—which is terrible b/c stroke risk goes up 4-fold. And they have to take anticoagulant.
So, to me, nothing starts w a huge lead over LAAO in such patients. And. LAAO vs nothing in older pts w bleeds is exact the trial that should be done.
This is outside of my field — nutrition, biochemistry — but my understanding from similar discussion on stents is that if you do not use the procedure, there is potential legal questions of whether patient was offered best treatment. It seems that there should be some agency that can define standards for patients’ informed consent. Possibly bigger than this venue but What is the state of that issue?
I think an agency (presumably governmental) that defined standards for informed consent would create a mess that only lawyers would love. I always advised patients to get second and third opinions on any potentially serious medical issue.
Thank you!
A friend in his early 70s with a history of heart attack and now AFib was using Eliquis but not enjoying the side effects. He also has a defibrillator and lives in fear of the damned thing going off and knocking him on his butt. Well, a nosebleed convinced him he couldn't tolerate the blood thinner so his doctor told him he was eligible for a Watchman, even though cauterization fixed the bleeding. I have been reading your articles here on the Watchman and watched your YouTube presentation on it. I sent the links to my friend. He read/watched and three weeks ago went ahead and got the LAAO with the Watchman.
The doc told him they no longer need to use Plavix post procedure. But he is on Eliquis again for a while. I am just a friend but am concerned for him. I did want to thank you, Dr Mandrola, for at least providing a counterpoint to the happy sales pitches for this device.
John
On your asterisk--knowing relative vs absolute is important, and also knowing that's the ABCs of establishing a successful trial, it strikes me as odd for the FDA tilts the playing field (if im reading right). They establish a risk ratio, sensible, but then use absolute numbers that are not anchored to the a priori marker of efficacy--as in your illustrative 20/18 example above. Whats the rationale there from FDA side. How do they justify their decision?