Reminds me of the recent NordICC trial that challenged the dominant thinking of screening colonoscopies. I've enjoyed watching GI tap dance around those findings.
Thanks for the usual honest assessment of the reasons for delayed publication here. I found this particularly interesting because ablation therapy was just beginning at near the end of my career and I really didn't know much about it. The cardiology portion of my practice was essentially limited to R & L heart catheterization with coronary angiography and pacemaker placement. So I had to look at a few videos in order to get up to speed on what is now standard protocol in ablation therapy. I have to admit that my appreciation for what EP cardiologists do has increased significantly. I can't imagine who would be working in the left atrium besides those trained in these techniques.
Intriguing. However, the operators who performed the AVATAR were likely highly experienced in standard cryoballoon PVI and so likely achieved isolation in the great majority of PVs with 2 applications. The supplemental data shows that only 12% of patients (not veins) required additional ablation after 2 applications in the conventional cryo arm - so likely 94-97% of PVs isolated in the AVATAR arm. In additional, not clear from the report how they avoided any assessment of PVPs in the AVATAR arm - assume they must have used Achieve catheter as a wire for balloon guidance. They did not say operators were entirely blinded to this information.
I’ve often wondered whether PV electrical isolation is actually a proxy for thermal energy transfer to the vagal innervation of the heart. In other words, left atrial ablation reduces AF recurrence by vagal denervation. The electrical isolation may merely be a marker (perhaps a good one) that one has actually generated transmural thermal lesions.
Good episode of this week in cardiology 12/8/23. Could not figure out how to give thumbs up on Spotify or Apple Podcasts. Keep the info coming. Thanks for your time.
I get the point of the study, but isn't this proof (!!) of how good PVIs are done with cryoballoons, compared to the old-fashioned PVIs done 'dot-to-dot'? I'd imagine that there are studies showing that 'dot-ot-dot' PVIs without checking the veins conduct to AF persistance and higher reablations.
Do you have additional information that supports your theory on why this study was rejected by multiple journals? Could it be that the low numbers , unblinded nature, very large cross-over numbers make solid conclusions difficult and weaken the study. Is it possible to look at what the reviewers actually criticized?
Also, you state that "oodles of studies" have shown that ablation "crushes" anti-arrhythmic drugs. can you cite those studies and what end-points are we talking about?
Thanks John. Takes courage to accept that a cherished professional practice has been disrupted by the science. An early formative experience for me was hearing a senior psychoanalyst report (back in 1978) that his research showed NO benefits of analysis for patients with schizophrenia, and that this then popular treatment approach should be discontinued by ALL therapists. The humility and openness to change was stunning for me and has influenced my whole career.
Unfortunately, this happens all the time in all fields of science, not just medicine. It's one of the reasons why I feel peer reviewed publications are obsolete vs open source journals with data transparency. The former seem to add no real value aside from acting as establishment gatekeepers.
Not sure there is an army of non ep trained docs ready or even interested in doing ablations no matter how "easy" they are. As a physician leaded of a very large group - I think the EP are safe here mainly cause no other interventional doc has any interest in follow up of afib patients.
The only financial risk is that if the procedure is simplified the equipment purchases may go down and maybe reimbursement a little bit EP docs are secure ...
Please, please, please let’s stop making the absence of evidence is not evidence of absence error. When the authors concluded that there was no difference between two of the arms they are completely misinterpreting the p-value of 0.6. P-values are used to bring evidence against a straw-man hypothesis but never to bring evidence in favor of a hypothesis. Note the small number of events in those two arms. A confidence interval for the hazard ratio would reveal that the study is uninformative about the equality of outcomes for those two arms. A large p-value means nothing more than “get more data”.
Thomas Kuhn's ideas in action! Throw financial incentives into the mix, and it slows paradigm shifts even further. Now that docs like you are self-publishing, maybe you mavericks should all start your own non-profit journal for paradigm shifting research!
Yes. In 2005 Dr.Jerome Kassirer, former editor of the New England Journal of Medicine, published a book titled On the Take in which he said that the vast majority of medical journals are nothing but marketing arms for the pharmaceutical industry.
Simply stated, yes. There are cabals of like minded individuals who will suppress heretics. See Matt Taibbi et.al. for the understanding of suppression one
‘True malinformation” that threatens the elite/dominant class.
In my professional world (Tech) we know this as Antitrust. It seems that it should be trivial to bring antitrust law to bear on this.
It’s in everyones best interests if studies like this inspire quick follow up studies to prove or disprove and let everyone get back to the serious issues.
Why I am so shocked is because a single study is never a smoking gun for anything, just a starting point for more serious review.
The study is not informative as an assessment of similarity of two treatments. That would require a much larger N, maybe > 500 events. An endpoint that includes patient-oriented outcome scales would greatly lower the needed sample size.
Reminds me of the recent NordICC trial that challenged the dominant thinking of screening colonoscopies. I've enjoyed watching GI tap dance around those findings.
John,
Thanks for the usual honest assessment of the reasons for delayed publication here. I found this particularly interesting because ablation therapy was just beginning at near the end of my career and I really didn't know much about it. The cardiology portion of my practice was essentially limited to R & L heart catheterization with coronary angiography and pacemaker placement. So I had to look at a few videos in order to get up to speed on what is now standard protocol in ablation therapy. I have to admit that my appreciation for what EP cardiologists do has increased significantly. I can't imagine who would be working in the left atrium besides those trained in these techniques.
“time to any hospital episode” is an insensitive endpoint. “Time to any episode requiring adjustment of medication” is more legitimate.
Intriguing. However, the operators who performed the AVATAR were likely highly experienced in standard cryoballoon PVI and so likely achieved isolation in the great majority of PVs with 2 applications. The supplemental data shows that only 12% of patients (not veins) required additional ablation after 2 applications in the conventional cryo arm - so likely 94-97% of PVs isolated in the AVATAR arm. In additional, not clear from the report how they avoided any assessment of PVPs in the AVATAR arm - assume they must have used Achieve catheter as a wire for balloon guidance. They did not say operators were entirely blinded to this information.
I do agree that this study should have been published promptly in a high-profile journal.
I’ve often wondered whether PV electrical isolation is actually a proxy for thermal energy transfer to the vagal innervation of the heart. In other words, left atrial ablation reduces AF recurrence by vagal denervation. The electrical isolation may merely be a marker (perhaps a good one) that one has actually generated transmural thermal lesions.
Good episode of this week in cardiology 12/8/23. Could not figure out how to give thumbs up on Spotify or Apple Podcasts. Keep the info coming. Thanks for your time.
I get the point of the study, but isn't this proof (!!) of how good PVIs are done with cryoballoons, compared to the old-fashioned PVIs done 'dot-to-dot'? I'd imagine that there are studies showing that 'dot-ot-dot' PVIs without checking the veins conduct to AF persistance and higher reablations.
John,
Do you have additional information that supports your theory on why this study was rejected by multiple journals? Could it be that the low numbers , unblinded nature, very large cross-over numbers make solid conclusions difficult and weaken the study. Is it possible to look at what the reviewers actually criticized?
Also, you state that "oodles of studies" have shown that ablation "crushes" anti-arrhythmic drugs. can you cite those studies and what end-points are we talking about?
Anthony
Thanks John. Takes courage to accept that a cherished professional practice has been disrupted by the science. An early formative experience for me was hearing a senior psychoanalyst report (back in 1978) that his research showed NO benefits of analysis for patients with schizophrenia, and that this then popular treatment approach should be discontinued by ALL therapists. The humility and openness to change was stunning for me and has influenced my whole career.
This is excellent. Thank you very much for showing how hard it is to disrupt The Science.
Unfortunately, this happens all the time in all fields of science, not just medicine. It's one of the reasons why I feel peer reviewed publications are obsolete vs open source journals with data transparency. The former seem to add no real value aside from acting as establishment gatekeepers.
Not sure there is an army of non ep trained docs ready or even interested in doing ablations no matter how "easy" they are. As a physician leaded of a very large group - I think the EP are safe here mainly cause no other interventional doc has any interest in follow up of afib patients.
The only financial risk is that if the procedure is simplified the equipment purchases may go down and maybe reimbursement a little bit EP docs are secure ...
Please, please, please let’s stop making the absence of evidence is not evidence of absence error. When the authors concluded that there was no difference between two of the arms they are completely misinterpreting the p-value of 0.6. P-values are used to bring evidence against a straw-man hypothesis but never to bring evidence in favor of a hypothesis. Note the small number of events in those two arms. A confidence interval for the hazard ratio would reveal that the study is uninformative about the equality of outcomes for those two arms. A large p-value means nothing more than “get more data”.
Thomas Kuhn's ideas in action! Throw financial incentives into the mix, and it slows paradigm shifts even further. Now that docs like you are self-publishing, maybe you mavericks should all start your own non-profit journal for paradigm shifting research!
First thing I thought about.
You know what they say about great minds! 🤣
Are the journals so embedded with the professionals that they seriously blocked this for years? Seems like a serious decoupling needs to occur.
Yes. In 2005 Dr.Jerome Kassirer, former editor of the New England Journal of Medicine, published a book titled On the Take in which he said that the vast majority of medical journals are nothing but marketing arms for the pharmaceutical industry.
Simply stated, yes. There are cabals of like minded individuals who will suppress heretics. See Matt Taibbi et.al. for the understanding of suppression one
‘True malinformation” that threatens the elite/dominant class.
Not new https://x.com/DrAJRestrepo/status/1734045060344275423?s=20
In my professional world (Tech) we know this as Antitrust. It seems that it should be trivial to bring antitrust law to bear on this.
It’s in everyones best interests if studies like this inspire quick follow up studies to prove or disprove and let everyone get back to the serious issues.
Why I am so shocked is because a single study is never a smoking gun for anything, just a starting point for more serious review.
The study is not informative as an assessment of similarity of two treatments. That would require a much larger N, maybe > 500 events. An endpoint that includes patient-oriented outcome scales would greatly lower the needed sample size.