Thank you for this paper and summary! What would you recommend for patients who can’t tolerate AC or AP and have a fib?
Would you recommend no therapy (LAAC or AC) or would you put in a LAAC and prescribe SAPT until the device has endothelized and then discontinue the agent?
So many utterly disappointing aspects of this saga, from the regulatory failures worldwide, to the failure of proponents to respond to the evidence (with the obvious added variant on an adage, that it is difficult to get a person to understand something, when their income, ad board invites, and opportunities to further burnish their “disclosures” list depends on their continued inability to understand it).
LAAC has failed to establish non-inferiority even with a ridiculously lax non-inferiority threshold. Well past the time for any sane person to face facts: it’s worse than OAC. And I totally agree that a physician’s job should not be to advise pts to opt for a worse therapy. I think there was once an oath about that sort of thing.
Couple of limitations that I would like to point out, if I were the reviewer
1. Why isn't the GRADE certainty not reported in the Abstract & conclusions? The GRADE certainty is "Low" here so the conclusion are of low/maybe and we need better and larger trials. You state paper follows PRISMA reporting guidelines but it hasn't. Seriously, why assess certainty if it's not included in the conclusion.? A lot of papers do this.
2. The paper says, "prespecified margin of RR = 1.40. Where is pre-specified and what's the rationale? I don't see it in the PROSPERO registration nor in the paper.
3. How can you decide the conclusions based on the CI's here? You just gathered what is out here. Your conclusion can easily change when there are more studies later. In fact, the paper even says, "The accrued sample size was 5,714, below the required information size of 11,538; therefore, the current evidence is insufficient to establish non-inferiority of pLAAO versus OAC under the prespecified RR margin of 1.40. " This goes back to the Low certainty rating and stating the uncertainty in the conclusions to the reader.
"We will pay for this device but only if the patient is in a trial" — I wish that sentence ran every device rollout, John! 600,000 procedures and still no clear answer is such a strange place to be. Thank you for breaking stroke and bleeding out of the composites, that's what made the picture readable for me.
Thank you for the many relevant posts you have done on this topic. I’m still surprised at the number of people who blindly accept this procedure. And I could just vomit when the ads for the Watchman appear on TV.
Excellent review, however, you have forgotten maybe the most important thing that effects my patients which is the cost of DOAC. DOAC costs > $400/month. A LAAC procedure is paid for my Medicare and its supplemental, with sometimes a minimal one time co-payment. So for a 65 year old who might live another 10-20 years at a cost of $400/month, that is a huge problem that you have not addressed. What is the value of LAAC in the setting of cost to the patient. (DOAC costs $5000/year. If the 65 year old lives to 85 that is a $100,000 extra cost over LAAC)
Fair to ask about cost. But there are costs for benefits.
And an ICER lens is not gonna work out well for watchman. Pretty tough to be “cost effective” when it’s not effective to begin with. “Free” is too costly for something that is useless.
Counadin is free. And it’s essl the same effectiveness and bleeding risk as DOACs. And monitoring can be quarterly once they’re on a stable dose. Been doing it for 50 years without a problem. And coumadin is reversible, unlike DOACs
Not lucrative to most cardiologists, as the vast majority of us are on salary. Doing extra procedures does not increase our income, but increases our exposure to radiation. Regarding "lucrative," how do you balance the cost of DOAC at $5000/year to the cost of LAAC to the patient? The vast majority of my patients don't pay anything, or at most a small deductible, for a one time LAAC. Do you want to pay $400/month until the day you die? I think not. So one must take in to consideration the cost of the procedure vs the cost of the drug
Sorry, it’s just as lucrative to the cardiologist cause they have to justify their existence to their masters. Why do you think we’re getting so many of these things done?
"...stroke (and bleeding) are thankfully low incidence events." So why bother with expensive drugs and interventions + what is the absolute risk reduction?
Good questions. I have seen dozens of these types of studies over the years and the very low rate of strokes attributed to atrial fibrillation raises the very question of causation. The "benefits" seem to be almost always canceled out by the complication of bleeding. How is the determination made that the stroke was caused by an embolus from the left atrium as opposed to occlusion brought about by a complication in a cerebrovascular plaque such as the hypothesized mechanism of a coronary thrombosis?
Thank you for this paper and summary! What would you recommend for patients who can’t tolerate AC or AP and have a fib?
Would you recommend no therapy (LAAC or AC) or would you put in a LAAC and prescribe SAPT until the device has endothelized and then discontinue the agent?
Regulatory failures seem to have significant impact on healthcare costs.
Has anyone specifically asked what those costs are, both potentially and real?
Congratulations on the paper.
So many utterly disappointing aspects of this saga, from the regulatory failures worldwide, to the failure of proponents to respond to the evidence (with the obvious added variant on an adage, that it is difficult to get a person to understand something, when their income, ad board invites, and opportunities to further burnish their “disclosures” list depends on their continued inability to understand it).
LAAC has failed to establish non-inferiority even with a ridiculously lax non-inferiority threshold. Well past the time for any sane person to face facts: it’s worse than OAC. And I totally agree that a physician’s job should not be to advise pts to opt for a worse therapy. I think there was once an oath about that sort of thing.
Here’s the oath of too many these days - 💰
Good work John!
Couple of limitations that I would like to point out, if I were the reviewer
1. Why isn't the GRADE certainty not reported in the Abstract & conclusions? The GRADE certainty is "Low" here so the conclusion are of low/maybe and we need better and larger trials. You state paper follows PRISMA reporting guidelines but it hasn't. Seriously, why assess certainty if it's not included in the conclusion.? A lot of papers do this.
2. The paper says, "prespecified margin of RR = 1.40. Where is pre-specified and what's the rationale? I don't see it in the PROSPERO registration nor in the paper.
3. How can you decide the conclusions based on the CI's here? You just gathered what is out here. Your conclusion can easily change when there are more studies later. In fact, the paper even says, "The accrued sample size was 5,714, below the required information size of 11,538; therefore, the current evidence is insufficient to establish non-inferiority of pLAAO versus OAC under the prespecified RR margin of 1.40. " This goes back to the Low certainty rating and stating the uncertainty in the conclusions to the reader.
"We will pay for this device but only if the patient is in a trial" — I wish that sentence ran every device rollout, John! 600,000 procedures and still no clear answer is such a strange place to be. Thank you for breaking stroke and bleeding out of the composites, that's what made the picture readable for me.
Thank you for the many relevant posts you have done on this topic. I’m still surprised at the number of people who blindly accept this procedure. And I could just vomit when the ads for the Watchman appear on TV.
Excellent review, however, you have forgotten maybe the most important thing that effects my patients which is the cost of DOAC. DOAC costs > $400/month. A LAAC procedure is paid for my Medicare and its supplemental, with sometimes a minimal one time co-payment. So for a 65 year old who might live another 10-20 years at a cost of $400/month, that is a huge problem that you have not addressed. What is the value of LAAC in the setting of cost to the patient. (DOAC costs $5000/year. If the 65 year old lives to 85 that is a $100,000 extra cost over LAAC)
Fair to ask about cost. But there are costs for benefits.
And an ICER lens is not gonna work out well for watchman. Pretty tough to be “cost effective” when it’s not effective to begin with. “Free” is too costly for something that is useless.
Counadin is free. And it’s essl the same effectiveness and bleeding risk as DOACs. And monitoring can be quarterly once they’re on a stable dose. Been doing it for 50 years without a problem. And coumadin is reversible, unlike DOACs
A very compelling analysis of a very lucrative procedure, with dubious benefit.
Not lucrative to most cardiologists, as the vast majority of us are on salary. Doing extra procedures does not increase our income, but increases our exposure to radiation. Regarding "lucrative," how do you balance the cost of DOAC at $5000/year to the cost of LAAC to the patient? The vast majority of my patients don't pay anything, or at most a small deductible, for a one time LAAC. Do you want to pay $400/month until the day you die? I think not. So one must take in to consideration the cost of the procedure vs the cost of the drug
Sorry, it’s just as lucrative to the cardiologist cause they have to justify their existence to their masters. Why do you think we’re getting so many of these things done?
A triumph of technology over reason. Question- patient is getting bypass and surgery offers open ligation/closure of LAA?
Why wouldn't you ligate the LAA?
"...stroke (and bleeding) are thankfully low incidence events." So why bother with expensive drugs and interventions + what is the absolute risk reduction?
Good questions. I have seen dozens of these types of studies over the years and the very low rate of strokes attributed to atrial fibrillation raises the very question of causation. The "benefits" seem to be almost always canceled out by the complication of bleeding. How is the determination made that the stroke was caused by an embolus from the left atrium as opposed to occlusion brought about by a complication in a cerebrovascular plaque such as the hypothesized mechanism of a coronary thrombosis?