To borrow from an old adage, it’s difficult to make someone understand something, when their income is directly tied to their continuing to not understand it.
It appears there are many US EPs in this category.
Great review. I'm an Interventional Cardiologist and General Cardiologist in clinic. One question for you John: What is the economic impact of AC vs LAAC? I've had this discussion with my patients. Medicare pays for LAAC, often with no copay. Medicare doesn't pay that well for NOAC, and the cost of NOAC at >$400/month for life is not trivial. Would you consider LACC based purely on the cost to the patient over a lifetime?
I would not. And even one of the proponents spoke about the tension of switching burden of payment from an individual to society. The simple answer is warfarin.
Thanks John. As always, great article filled with facts and explanations. The world of electrophysiology - both clinically and commercially - is concerning. I have spent 25+ years in medical device innovation but never have I seen so much manipulation of data as witnessed in EP the last five years. LAAC is very similar to PFA in this regards.
Hmm, I cannot take blood thinners, so I had a maze procedure on the outside of the heart, and a clamping of the left atrial appendage, as opposed to an internal ablation with a watchman device. So far so good!
This proves our rule that I found to be quite true when I ran the Practice. What you “incentivize you achieve”. If there is no incentive financially to put in closure devices in Canada or the incentive is, it’s the right thing to do and people aren’t doing it , there are two possibilities. The Canadian physicians feel it is a worthless procedure or it’s a good procedure that takes too much time and they’re not compensated enough.
This may be a stupid question for a dumb non-EP cardiologist; there have been thousands implanted by now. Has that date been looked at in anyway?
Sort of like with back surgery after five years the only difference between surgery and non-surgery is the surgical patients have a scar.
MP. One of the most regrettable things is that FDA did not mandate further evidence. Thus, about 500,000 devices have been done worldwide and if only a fraction of them were randomized, we’d know. Nonrandomized observational studies cannot answer efficacy and safety issues.
I'm a Canadian (cyclist, hi John), I first found John from reading the "Haywire Heart". The most likely reason that the Canadian doctor said that LAAC wasn't performed much in Canada isn't due to science or clever medical reasoning but because we ration healthcare. It is built into the system. Yes we have a "true" universal healthcare system that Canada shares this with Cuba and North Korea...what does that say? We are our own worst enemy. Canadians ever keen to show we think we are better than the USA accept poorer healthcare because the USA is used as the option instead of a fairer comparison with the far more successful OECD outcome. Canadian healthcare hasn't collapsed...yet, only because the burned out hospital staff actually care. I'm age 68, ablation in 2022 for proximal AFIB, flutter. Good outcome, no AFIB but zero follow up about fairly drastic changes post ablation other than confirming no AFIB. It's kind of having a broken leg treated but being ignored when you point out that your foot is now clocked sideways......yes but you don't have a broken leg anymore is not very helpful. I have had good and appalling dealings, some that make me wonder if doctors here are mandated to stay current or if it happen just because they chose to? Just trying to give another perspective.
True but many if not all OECD countries have a parallel privately delivered side that is paid by the government. Treatment can be received from either the public or private side at the same cost if any to the citizen. Canada has this already. GPs, imaging are private and publicly paid. Canada the poorly performing system it is because the argument has been it's our wonderful universal system or the evil one in the USA. I personally think the Canadian system will not be altered until it collapses completely because all political parties have had a hand in maintaining the status quo. It only operates because of the mostly front line staff who truly care at the expense of their own health. Check the link which shows our healthcare comparators in the EU. https://secondstreet.org/video/#abroad
This is not new. I have observed this for decades. Marcia Angel (former NEJM editor) called this out 25 years ago (see her book).
NEJM also published outright fraud during Covid with the Sugisphere “data” discrediting HCQ (retracted in 2 weeks when caught red handed). They also published other poorly designed trials that were designed to fail. The examples are endless.
A previous BMJ editor said presume publications are fraudulent.
To quote the book of Ecclesiastes “there is nothing new under the sun.”
Truly excellent
I personally would refuse AC if I had AF, so I don't think it's just about non inferiority, it's about, for me, whether LAAC is better than no AC.
Blind men and the Elephant.
Electrophysiologist are smart; that is often true. But Industry Representatives and their finances are much smarter!!
To borrow from an old adage, it’s difficult to make someone understand something, when their income is directly tied to their continuing to not understand it.
It appears there are many US EPs in this category.
This adage is a quote from Upton Sinclair: 'It is difficult to get a man to understand something when his salary depends on his not understanding it.'
Thanks. Nice to see the original. It’s so well worn that I forget the original wording after seeing it used in some many different contexts.
Maybe because we ALL know that the FDA is revolving door.
Brilliant review! I hope the truth prevails.
Great review. I'm an Interventional Cardiologist and General Cardiologist in clinic. One question for you John: What is the economic impact of AC vs LAAC? I've had this discussion with my patients. Medicare pays for LAAC, often with no copay. Medicare doesn't pay that well for NOAC, and the cost of NOAC at >$400/month for life is not trivial. Would you consider LACC based purely on the cost to the patient over a lifetime?
I would not. And even one of the proponents spoke about the tension of switching burden of payment from an individual to society. The simple answer is warfarin.
Thanks John. As always, great article filled with facts and explanations. The world of electrophysiology - both clinically and commercially - is concerning. I have spent 25+ years in medical device innovation but never have I seen so much manipulation of data as witnessed in EP the last five years. LAAC is very similar to PFA in this regards.
I guess it shows that the sales force of Boston Scientific is more powerful than a flawed study. Thank you for the critique!
Thank you for this! one question though--how were your arguments received by your colleagues? did they see the light?
Based on the huge popularity of LAAC, it’s clear that I have lost the debate. And I’ve spoken on it on five continents.
Oh, i think that is so unfortunate.
Hmm, I cannot take blood thinners, so I had a maze procedure on the outside of the heart, and a clamping of the left atrial appendage, as opposed to an internal ablation with a watchman device. So far so good!
This proves our rule that I found to be quite true when I ran the Practice. What you “incentivize you achieve”. If there is no incentive financially to put in closure devices in Canada or the incentive is, it’s the right thing to do and people aren’t doing it , there are two possibilities. The Canadian physicians feel it is a worthless procedure or it’s a good procedure that takes too much time and they’re not compensated enough.
This may be a stupid question for a dumb non-EP cardiologist; there have been thousands implanted by now. Has that date been looked at in anyway?
Sort of like with back surgery after five years the only difference between surgery and non-surgery is the surgical patients have a scar.
MP. One of the most regrettable things is that FDA did not mandate further evidence. Thus, about 500,000 devices have been done worldwide and if only a fraction of them were randomized, we’d know. Nonrandomized observational studies cannot answer efficacy and safety issues.
I'm a Canadian (cyclist, hi John), I first found John from reading the "Haywire Heart". The most likely reason that the Canadian doctor said that LAAC wasn't performed much in Canada isn't due to science or clever medical reasoning but because we ration healthcare. It is built into the system. Yes we have a "true" universal healthcare system that Canada shares this with Cuba and North Korea...what does that say? We are our own worst enemy. Canadians ever keen to show we think we are better than the USA accept poorer healthcare because the USA is used as the option instead of a fairer comparison with the far more successful OECD outcome. Canadian healthcare hasn't collapsed...yet, only because the burned out hospital staff actually care. I'm age 68, ablation in 2022 for proximal AFIB, flutter. Good outcome, no AFIB but zero follow up about fairly drastic changes post ablation other than confirming no AFIB. It's kind of having a broken leg treated but being ignored when you point out that your foot is now clocked sideways......yes but you don't have a broken leg anymore is not very helpful. I have had good and appalling dealings, some that make me wonder if doctors here are mandated to stay current or if it happen just because they chose to? Just trying to give another perspective.
Canada doesn't just share a true universal healthcare system with Cuba and North Korea. Most of Western Europe has similar universal systems.
True but many if not all OECD countries have a parallel privately delivered side that is paid by the government. Treatment can be received from either the public or private side at the same cost if any to the citizen. Canada has this already. GPs, imaging are private and publicly paid. Canada the poorly performing system it is because the argument has been it's our wonderful universal system or the evil one in the USA. I personally think the Canadian system will not be altered until it collapses completely because all political parties have had a hand in maintaining the status quo. It only operates because of the mostly front line staff who truly care at the expense of their own health. Check the link which shows our healthcare comparators in the EU. https://secondstreet.org/video/#abroad
This is not new. I have observed this for decades. Marcia Angel (former NEJM editor) called this out 25 years ago (see her book).
NEJM also published outright fraud during Covid with the Sugisphere “data” discrediting HCQ (retracted in 2 weeks when caught red handed). They also published other poorly designed trials that were designed to fail. The examples are endless.
A previous BMJ editor said presume publications are fraudulent.
To quote the book of Ecclesiastes “there is nothing new under the sun.”
Do you think financial incentives have any influence on their practice?