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CABANA Trial general consent

Posted by fravi 
CABANA Trial general consent
May 11, 2018 12:37PM
I was wondering if there is a general consent within the EP community regarding the CABANA trial. It will be nice if Shannon or someone who attended the presentations and panel discussions can give us an update,

Thanks!



Edited 1 time(s). Last edit at 05/11/2018 12:39PM by fravi.
Re: CABANA Trial general consent
May 11, 2018 03:02PM
Well it seems that the Cabana trial doesn't seem to think that an ablation is much better than taking drugs.

Liz
Re: CABANA Trial general consent
May 11, 2018 03:44PM
Quote
Elizabeth
Well it seems that the Cabana trial doesn't seem to think that an ablation is much better than taking drugs.

Liz

Except for the fact that successful ablation has zero side effects where as meds not so much.

Also, this study only took into account an older segment of the affib community (over 65 I believe with some other caveats) if im not mistaken). So long term effects of medications, for someone such as myself that has been dealing with affib for over 25 years, aren't even addressed in the study.

IMHO, the study, though possibly good on some merits is not the be all end.

Dr. John Mandrola is supposed to have a write up in the couple days on his blog.
Re: CABANA Trial general consent
May 11, 2018 04:48PM
Rocketritch said:


{ Except for the fact that successful ablation has zero side effects where as meds not so much}.

That isn't exactly true---What exactly is a successful ablation, is it that you no longer get AF but you may have to stay on blood thinners. There are a few people on here that have had a "successful ablation" but still need to stay on blood thinners.

I agree with you the study is flawed.

Liz
Re: CABANA Trial general consent
May 12, 2018 09:10AM
Re: CABANA Trial general consent
May 12, 2018 02:40PM
The problem with ablations there are so few doctors that are good at it, I know a couple of people that have had 3 or 4 ablations, as well as reading about them on this board. My EP never offered an ablation to me, perhaps because I didn't get a lot of AF episodes for many years and I was doing ok overall.

This is a comment taken from the study:

Dr. Stephen Benzian| Radiology
1 day ago


This study will probably influence many to forget about ablation and go for anti-coagulation. Patients will have deadly intracranial bleeds and MD's are doing a poor job of alerting the patients of this risk. I have some experience with this subject as my brother died from a subdural from coumadin...he was never offered an ablation nor was he aware of the risks of intracranial bleeding from a fall.

Liz
Re: CABANA Trial general consent
May 12, 2018 06:09PM
IMHO a successful ablation eliminates at the very least the need for antirhythmic and rate control drugs as well as anticoagulants. I had one of those once.
And I would also say if you had to remain on anticoagulants that would be successful as well.
Quality of life is the best guage of success. In my particular case I am very symptomatic with the affib. And the meds make me feel just as bad if not worse.
My mother on the other hand doesn't even realize when she is in affib and the rate control drugs don't seem to bother her.



Edited 1 time(s). Last edit at 05/12/2018 06:12PM by rocketritch.
Re: CABANA Trial general consent
May 12, 2018 06:53PM
Quote
Elizabeth


Dr. Stephen Benzian| Radiology
1 day ago


This study will probably influence many to forget about ablation and go for anti-coagulation.

Liz

??? I wonder what study he was looking at.
Re: CABANA Trial general consent
May 12, 2018 11:49PM
Hi Folks.

The CABANA RCT is actually a solid and overall positive report on AFIB ablation versus drugs! The knee-jerk Cardio press got it nearly universally wrong .. .not surprisingly. The primary endpoint use of an 'Intention To Treat (ITT)' analysis that has its place for sure in statistical studies, but can give skewed results, as it does here, when the drug-only arm in mid-stream of the study sent over 300+ patients to the Ablation arm.. And furthermore, also skewing the results were close to 130 patients all assigned to the ABL arm that never even received an ablation at all!!!

Needless to say, its not possible to show a benefit from an ablation procedure unless the participants in that arm of the study all had the ablation!

There are a number of other significant caveats in CABANA, and yet the initial press reports all focus on the one set of primary endpoints viewed through an ITT window when not all the patients that were enrolled in both the ablation and AAR/Rate Control drug arms actually got the assigned therapy or procedure!!

Nearly al the EPs at the huge HRS 2018 where CABANA was presented were well aware of this limitation to the RCT and were not surprised. A recipe for misleading results!

Dr Douglas Packer Principal Investigator of CABANA and well known Cardiologist Dr. Eric Prystowski ... a classic drug man ... both urged the medical press at the start of the big CABANA presentation to NOT get blinded by the initial primary outcome report. They both said the good news about ablations vs drugs was abundant within the details of the trial and they urged the press again to please don't pronounce a verdict only based on the ITT analysis alone, but first look deeply into all the real world factors that clearly show AFIB ablation in the most practical light so many legions of us have come to appreciate first hand!

So that is what we are going to do here, since the medical press nearly completely ignored what Drs. Packer and Prystowski had asked them to do, by waiting until August to fully read and digest the deeper facts of CABANA before making any grand pronouncement in their publications until they understand far better what CABANA actually says!!

The last two days of HRS was largely a celebration of the very solid ablation results from CABANA, but because the medical press ran with the sensational rather than the carefully rational headlines, and apparently figure they can add more clarifications and corrections to their very narrow view initial reporting when the complete published study comes out in August,

In any event, its midnight in Boston and I have to wake up at 5:15am to catch my longish 5.5 hour flight back to Phoenix so I'm signing off here and good night to all! More later ...

Shannon



Edited 2 time(s). Last edit at 05/13/2018 12:16PM by Shannon.
Re: CABANA Trial general consent
May 12, 2018 11:50PM
The following from Dr. John Day supports what Shannon just posted:

9 Reasons Why Ablation Beats Drugs for Afib: CABANA Study Results

Why Ablation Beats Drugs for Afib



Edited 1 time(s). Last edit at 05/13/2018 12:36AM by JakeL.
Re: CABANA Trial general consent
May 13, 2018 01:42AM
Quote
JakeL
The following from Dr. John Day supports what Shannon just posted:

9 Reasons Why Ablation Beats Drugs for Afib: CABANA Study Results

Why Ablation Beats Drugs for Afib

"In my opinion, the big take away from the CABANA Study is that ablation beats drugs for atrial fibrillation. The thing that was missing from this study is lifestyle optimization. Indeed, with aggressive lifestyle changes half of all patients can put their atrial fibrillation into remission without drugs or procedures."
Joe
Re: CABANA Trial general consent
May 13, 2018 03:02AM
Quote

Indeed, with aggressive lifestyle changes half of all patients can put their atrial fibrillation into remission without drugs or procedures."
At least something to give me hope to stay off the 'table'.
Re: CABANA Trial general consent
May 13, 2018 11:51AM
jpeters - He was responding to the CABANA study results at the Medscape website... at the end of the report, there is a place where readers can comment.
Re: CABANA Trial general consent
May 13, 2018 12:33PM
Quote
Jackie
jpeters - He was responding to the CABANA study results at the Medscape website... at the end of the report, there is a place where readers can comment.

I concluded just the opposite.
Re: CABANA Trial general consent
May 13, 2018 01:15PM
(Thanks JakeL! For the link to Dr John Day’s outstanding summary of the real value of CABANA! I consider Dr Day’s response to the largely wrong-headed Cardio journalist initial knee jerk reports, to be required reading by all Afibbers! Very well done Dr Day 👍👍!!)

I obviously fully support Dr John Day, quoted above and who is a friend of mine, in his very laudable efforts at encouraging life-style risk factor management discussed toward the end of his excellent summary of the value of CABANA RCT, via adoption of healthy eating, stress reduction and the full gamut of good ideas that we too have strongly advocated and shared on this oldest AFIB patient advocacy site since our very inception.

Nevertheless, our real world experience here with going on 20 yrs as the first and most dedicated AFIB resource focused on promoting ‘self-health’ good habits and specific electrolyte repletion, is that a fair degree less than half the patients who make such a concerted long term effort at life-style risk reduction are able to sustain NSR indefinitely only by those means.

I’m sure Dr Day derived the stats about 50% can stop AFIB solely with life style risk reduction
from the also excellent research on Life style risk reduction from renowned EP Prash Sanders team in Adelaide Australia that is important work. Howevet, on this point I consider it still way too early in our longer experience to pronounce persistent freedom from all atrial arryhtmia by 50% of all-comers with AFIB/Flutter Via only life style and dietary and weight loss methodologies.

I can support that these very valuable good health habits can indeed greatly reduce AFIB burden in a large number of patients who are vigilant in their adoption of such consistent long term life-style changes for the better. But in my following so closely so many of our very proactive group here at Afibbers.org, the large majority of those who have made a long term dedicated effort at truly putting the lid back on the Atrial arrhythmia kettle have discovered that they also at some point have needed to include ... and complete ... an expert ablation process in addition to sustaining those great new health habits learned here to achieve as close to a functional ‘cure’-like elimination of all atrial tachycardias of any stripe long term.

Again, this is not in any way to minimize the value of adoption of these long supported efforts we encourage everyone to adopt here. But I feel too that with our unprecedented long history of advocacy of the wisdom of combining the best examples of both improved self health care with the very best of electrophysiology, has proven far and away the most successful strategy for the largest numbers of our readers toward achieving genuine practical freedom from all arrhythmia.

Just keeping it real here Folks! And yet, it’s a win win protocol too! By recommending newcomers to our site to grab the bull by the horns and make a true committed effort at improving those aspects of personal health care such as improved eating, it insures that those among us who might possibly truly and entirely stop their atrial arrhythmia burden via such natural and/or life style risk reduction means, will surely discover that fact over the first full year of such commitment to turning your core health around.

And by the same token, if after a full year of such consistent effort, if one is still experiencing even modest, though significantly reduced episode frequency, it’s far better to include the expert ablation process then, and not keep procrastinating in no-man’s land accepting moderate AFIB frequency just because it is a somewhat lower burden than before life-style risk reduction efforts ... that is not real success in my book.

Compromising on accepting moderate AFIB in one’s life almost always leads eventually to run away AFIB which then often results in persistent AF.

One needs to be demanding of their self-health methods to achieve near total elimination of AFIB. If they can’t get better results than a just a modest reduction in AFIB burden then by all means include the expert ablation process sooner rather than thinking up 100 & 1 rationals for further procrastination. Add in that Ablation process in combination with life-long good health habits for the best odds to truly put this whole nightmare of AFIB in the rear view mirror for good!

Our collective experience is that a large majority will eventually need to include that expert ablation process to truly become free from all atrial arrhythmia long term.

Cheers!
Shannon



Edited 3 time(s). Last edit at 05/13/2018 03:00PM by Shannon.
Re: CABANA Trial general consent
May 13, 2018 06:32PM
This forum has some of the most aggressive lifestyle modifiers you'll encounter anywhere, and I've seen almost no one claim they've achieved freedom from afib via such means, and that includes me. Symptom reduction, yes. Some degree of prevention/termination of episodes, yes. But actual elimination? That, in my opinion, is a unicorn.
Re: CABANA Trial general consent
May 16, 2018 10:10PM
I'm wondering if those that have success initially had many comorbidities which they could eliminate. From my observation, many with the comorbidities were adrenergic. Many of the very aggressive lifestyle modifiers here were fit and vagal and came to the afib party with an excess of exercise. Hence they had less they could modify. That being said, it is usually very difficult for those with the comorbidities to modify them long term, though not impossible.

I'm one of the vagal guys, I have been relatively successful at keeping afib in remission, but I'd never say I'd eliminated afib. I know very well there is a very thin wall between me and an episode, hence I must be very diligent.
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