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Michael Sikorav MD's avatar

So both thermal and PFA ablation carry this risk, but PFA is probably riskier ? Im a getting this correctly ? Thanks

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Michael's avatar

There must be a reason for the procedure time difference with Europeans. Years vs months of experience?

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Andreas's avatar

You can 'heal' those cells partially by losing weight, exercise, drink alcohol sensibly, treating coexisitng high blood pressure and diabetes adequately - there is strong evidence that AF can improve substantially by addressing the above...

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Candy's avatar

Thank you for this

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TerriM's avatar

John, thanks for reporting on this

The idea of destroying parts of the heart seems crazy to me. Every time I read about it I keep thinking that there *has* to be another way. Why can't we heal the cells that are causing the issue instead of killing them??

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Ernest N. Curtis's avatar

Trying to draw conclusions from events with low rates of incidence is always problematic. Dr. Mandrola correctly points out that the numbers are too low for definitive statistical analysis but the three to zero incidence of MRI lesions warrants caution and further study. It wasn't clear from the brief summary whether those patients had pre-op MRIs and that they were definitely new lesions. The two to zero incidence of tamponade is further reason for caution and further gathering of comparative statistics.

As an aside that has nothing to do with the quality of the article, I would like to register a minor objection to the first two sentences. I understand that it is common practice to begin an article with some general statements in order to supply context for what is to follow. But when they make broad statements that are unsupportable it may compromise the main text in the mind of the reader. In this case, the article began: "The richer a society gets the higher the rate of atrial fibrillation. Obesity, lack of exercise, alcohol use, and advancing age are the main drivers of AF." I would say that the richer a society gets the higher the rate of DETECTION of atrial fibrillation. I am willing to buy the advancing age as a factor but seriously doubt there is any evidence to indict the other three as causal factors.

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Steve Cheung's avatar

“IF (JMM) were the regulator”….we would be less awash in therapies and devices approved only on the basis of surrogate endpoints, and less lacking in rigorous and meaningful post marketing surveillance.

Those brain lesions don’t look like “nothing” to me….and actually look a lot like the stuff we attribute to people with cognitive impairment and “vascular dementia” in older age.

It’s once again a dereliction of duty by regulators to not insist on further information about this safety signal.

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Gordon Banks's avatar

We neurologists do not feel that "silent" brain lesions are OK. The brain has plasticity and can compensate for lost neurons up to a point, but with age, this gets less robust. Our means of testing for the effects of damage is not very good, and the only way to properly study this would be neuropsychologic testing done before and after the ablation, which would be quite expensive. When I had my ablation, I had a flurry of complex migraines lasting a few days afterwards. My guess is that it was caused by platelet emboli coming through the hole he made in the septum. I didn't notice any cognitive effects and didn't get an MRI after. Platelets are high in serotonin and I previously had visual migraine, so I knew I was susceptible.

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Crixcyon's avatar

Brain safety...get rid of 5G.

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david kessler's avatar

matt

we may not have 10,000, but it’s a very reasonable study for our group. As Matt knows, the most dangerous thing to a patient with AF is a stroke. The second most dangerous is SOMETIMES a doctor trying to fix it. Having said that, PFA is a revolutionary technology, and I look forward to the studies.

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Eric F. ONeill's avatar

Well said. Even I, a lowly plastic surgeon can appreciate the critique of this article.

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Matt Phillips's avatar

As a cardiologist I used to say what would we do for our mother? Now as a 67-year-old cardiologist I ask what would I do for myself? Atrial Fibrillation is not a lethal illness. Unless you are incredibly biased, unless something out of this presentation you've talked me out of it. There's no way I would let them do PFA until they did another 10,000 patients which should happen pretty quickly and show the MRIs. But that's not going to happen.

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david kessler's avatar

john

This is one technology I think you should try using before passing judgment. I, too, have been a medical conservative. But, the safety of PFA for me (compared to thermal), has made me a believer in the technology. In fact, I was much quicker to AV node ablation and pacing particularly in the active octagenarian. With the safety of PFA, that has changed dramatically.

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Lisa Peterson's avatar

I appreciate this information. Had PFA 2 years ago as part of the study to get in the USA. Currently off all medications and feeling greatly better than before. Have not noticed any cognitive impairment. There is a cost benefit to either side of this. Not having an ablation results in a lifelong dependency on medication that has harsh side effects for some plus the presence of AFIB on a daily basis. In my case I am far healthier post ablation and better able to remain active and living a full life. Again, I’m off all medications. My goal at age 68 is to maintain that for as long as possible.

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Matt Phillips's avatar

DAVID saying he's in medical conservative is sort of like Donald Trump saying he enjoys the limelight. It's a bit of an understatement. David is the cardiologist in Austin we send our patients to when we want to know if they actually need a procedure. It's very interesting and I'll have to talk to him because John convinced me otherwise -see my comment below

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Ally's avatar

Maybe we shouldn’t expect to live past 85 or so. Every one of my family that made it into their 90s didn’t want to live the last 5 years of their life. Decreased mobility, digestive troubles, aches and pains, heart problems—-they’re inevitable and maybe not worth the extra years. And I’m not even talking about dementia—which might actually make old age bearable. I’m talking about family that was sharp as a tack well into their 90’s. A-fib is an old persons disease. Do we really need invasive treatments?

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Matt Phillips's avatar

I'm going to see my 96-year-old dad today. He still shooting pool and drives. His 95-year-old sister was doing the New York Times crossword puzzle on Sunday in ink. Sadly, she died on her birthday. Depends on your DNA though doesn't it?

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Crixcyon's avatar

My dad just turned 97 and is living on his own. He gave up driving a few days ago since his eye health is not so good. His father lived to be 101. If it's genes, I am not so sure I want to live to be 95-100.

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Sheryl Rhodes's avatar

Sobering thoughts about aging and desirability of certain medical interventions and procedures. In the case of AF, though, the bad quality of life in advanced cases, and the very high risk of stroke, would seem to make a good case for ablation.

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Dejan Mihailovic's avatar

High risk of stroke only if one has other morbidities. AF is only a symptom.

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Sheryl Rhodes's avatar

I’m an attorney, not a doctor, but I am interested in medical matters and science in general. As my husband was diagnosed with AF a few years ago, I want to learn all that I can. My given understanding from his doctors and the reading I have done is that AF frequency increases with age but that there are no other known risk factors for developing AF or for triggering an episode. In any case, it is stated as a certainty that the pooling of blood that occurs during an episode often leads to blood clotting and strokes, without the need for co-morbidities as an additional factor.

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Ernest N. Curtis's avatar

As a cardiologist with forty years of experience I have always had questions about some of the commonly accepted theories about atrial fibrillation and stroke. Various cardiac disorders may lead to atrial fibrillation but there are many people who experience that rhythm disturbance who have no identifiable cardiac disease. There are many who experience disorders involving the electrical system of the heart who have no structural heart abnormality. The evidence for atrial fibrillation as a sole cause for stroke is slim at best. Having performed hundreds of catheterizations where we watch and record the passage of contrast media through the chambers of the heart and out the aorta, I have always been skeptical about the so called "pooling of blood" in the left atrium. After all, it is not like a quantity of blood sitting in a bowl somewhere and then clots. The movement of the blood through the chambers of the heart is quite brisk and I question the concept that clots can form in the one second or so that it may "pool" in the atrium between successive beats. I have never seen a credible counter argument to this but would welcome any reference to the contrary. Many studies have been published on the use of anticoagulant medication for prevention of stroke in patients with atrial fibrillation. Many show no significant difference and in most of those that show a very small difference in the incidence of stroke, that benefit is essentially wiped out by the incidence of serious bleeding due to the anticoagulants.

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Sheryl Rhodes's avatar

Fascinating! Thank you for sharing your experience and thoughts on this topic. You’d think if the risk of stroke was so high, there would be clear evidence of the exact parameters of the type and degree of risk by now.

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JohnM543's avatar

"The richer a society gets the higher the rates of atrial fibrillation. Obesity, lack of exercise, alcohol use and advancing age are the main drivers of AF.

The AF-treatment market size in the US is measured in the billions of dollars. It’s expected to grow at high rates, powered largely by expansion of catheter ablation."

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And we are surprised still when the medical complex seems completely uninterested in solving the root cause of health problem$...

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