Is AF ablation a big placebo?

Turkish authors boldly raised this question in a recent editorial.

They likened AF ablation to renal denervation, a procedure in which RF ablation in the kidneys was felt to reduce BP. Many studies showed kidney ablation markedly lowered BP. Then a trial was done with a sham control (people got part of the procedure but did not have burns to the kidneys) and there was no difference.

Does AF ablation work the same way? Is it a big placebo? In over 5000 reports of AF ablation in the medical literature, not one is a true sham-controlled study.

People will argue AF ablation works; there are recordings before and after ablation (I have such tracings).

Then there are these scenarios: A patient has incapacitating AF. Then he has an ablation. He feels much better. At follow-up three months later, he thanks me for giving him his life back. But…sit down for this… he’s in AF by the ECG.

People will say a sham control study of AF ablation is unethical because of harm.

Well, think of the thousands (perhaps millions) of patients who would have had their kidney’s ablated if not for a proper trial. Another example of placebo effect comes in using pacemakers for vasovagal syncope (fainting). The first study of pacemaker versus drug in vagal syncope showed pacemakers worked, but the second study in which pacemakers were used as a sham (either on or off), found no difference.

There’s also never been a sham-control study of stents for the relief of angina. Gulp.

We know that the bigger the placebo, the stronger its effect.

I’m not posting on this because I know the answer, or because I don’t believe in what I do. I’m posting about this because it is intensely curious–and because it gets to the difference between being a doctor (a wise advisor) versus a robotic provider. Doctors, because of our position, may be able to deliver bigger placebos.

Three links are worth reviewing:

Dr. Brain Olshansky is a full professor in EP and he has over 200 peer-reviewed publications. He is solidly “in the club.”

Here is his (free) 2007 state of the art paper in the Journal of the American College of Cardiology: Placebo and Nocebo in Cardiovascular Health Implications for Healthcare, Research, and the Doctor-Patient Relationship

Here is a recent Grand Rounds lecture he gave: (The AF ablation part is in the middle, but you shortchange yourself by not watching the entire hour.)

I also attach this NEJM editorial from Rita Redberg on the importance of sham controls in medical device trials.

And a final thought: there are people working hard to learn more about the brain-heart connection in AF.

JMM

9 comments

  1. I am a newcomer to PAF world(6mo), saw EP at my request at month 5, who took me off all meds, gave rx for flec/ metoprolol for PIP, strongly recommended lifestyle changes(wt loss 40-50lb). Definitely not suggesting ablation, yea. Its only been a month but I havent felt better in years. No sotalol, no afib… More energy. Learning mindfullness meditation to deal with the anxiety that entered my life with the a fib… Joined a gym. I sent my EP an email thanking him for helping me, even if a fib rears its ugly head up again, I will still be so thankful to have a month of feeling great and getting my life back that a fib and sotolol side effects took from me.

  2. Palcebo I’m not sure of that! What I am sure of is I do not have heart rates in the 190 to 200/minute any more. Does my heart go into A-Fib there are times I feel short burst nothing Substained, I feel good! I agree taking good care of Ur self by controlling Ur weight , b/p, being active, eating healthy, regular checkup’s with Ur Doctors…in general a healthy Lifestyle is the Key to Good Health no matter what co-morbidities U may have. Thank you Dr. M, I feel U have given Me my life back!

  3. I had a PVI by 2nd generation cryo. Unless I’ve been lied to, it was not a sham. Difference: AF vs sinus. Night & day.
    I cannot comprehend how a person could by so isolated from his own body as to miss that his AF has returned.
    Placebo works if the subject believes. That would take deeply committed falsification on the part of the “provider”. Not a relationship I would want with my doctor.
    “Also I will, according to my ability and judgment, prescribe a regimen for the health of the sick; but I will utterly reject harm and mischief”
    Blind science vs Hippocrates.

  4. John, I salute you for highlighting these important questions. I don’t do ablations but I have sent a lot of my refractory AF cases for ablation and the majority end up with recurrent AF at some point. I have had similar cases with cardioversion of AF to what you describe-patient feels tremendous one month after his cardioversion but by ECG he is back in AF.
    And , two weeks ago I diagnosed a case of esophageal-atrial fistula (by TEE no less!) occurring one month after an ablation done at another hospital. This well-recognized complication of PVI ablation procedures is 100% lethal unless diagnosed and surgically treated rapidly.
    How many patients are informed of this possibility?

  5. Beavis and Butthead Read Dr. John’s Blog (warning: humor ahead)

    Beavis: Let me see… Dr. Man-dro-la… “Is AF Ablation a Big Placebo?”
    Butthead: Uh, huh huh…placebo? He must be talking about Placebo Dumb-ingo the opera singer dude… “Oh-solo-me-yo”. Huh huh.
    Beavis: Don’t be a dumb-a55, he’s talking about burning people’s hearts.
    Butthead: Burning people’s hearts? Huh huh. That sounds pretty cool. Sniff sniff, something’s burning. It’s your heart! Huh huh. I had heart burn once.
    Beavis: He’s a doctor, you dork. They burn and shock people’s hearts with those paddles.
    Butthead: I wanna get a set of those paddles so I can wake you up in the morning, Beavis. Zap Zap! Good morning Beavis. Did you rest peacefully last night? Zap Zap! Huh Huh.
    Beavis: Get serious, Butthead, Dr. Mandrola is asking if what he does for a living is fake.
    Butthead: That sounds pretty stupid. He is saying how he makes money is fake. Are you sure he’s not one of those Cairo-tractor dudes? Google “stupid”… see if Dr. Mandrake’s name comes up. Huh huh.

    :-))))))))

  6. Symptoms are often a lot worse after an ablation before they get better. How could this be due to the placebo affect?
    Also effectively there are placebo trials taking place as the quality of the operators varies so much. Experienced operators can get success rates of 75%+ first time round whereas inexperienced operators achieve only about 30% or less. If placebo was a major factor, these success rates would be much closer.

  7. I have had 3 episodes of PAF, I think. My heart was irregular and I took a rhythm strip with my cell phone (ALIVE COR). 30 day holter was neg. There was a lot of interference and narrow complex irregular beats on the ALive Cor strip but I think it was afib. Converted with propafenone per my cardiologist)( I am an internist / hospitalist).
    I have quit drinking alcohol, take my BP daily ( now running 110-140 systolic on meds). Cut back on eating when not hungry. Weight:157. The bouts were always associated with prolonged exercise/ fatigue/dehydration.esp:. Cycling for 5 hours or more. Perhaps sugar ingestion triggers this in me?.
    I am 73. Now I am trying to see how much exercise I can do without another bout. Dont want to be ablated as I am aware of the risks. The idea that the procedure may work due to the placebo effect is interesting. Maybe patients do better because of the lifestyle changes recommended before ablation are actually kicking in? I hope so.

  8. I was never ashamed to be a therapeutic nihilist. Just because everyone does it, doesn’t make it right. (To misuse a phrase repeated to my kids ad nauseum)

    I’m still not totally convinced that rate control is inferior to the risk of esophageal perforation in the majority of patients.

  9. John,
    You find some of the most interesting things. You were right, watching the whole hour (and 5 min) should certainly be worthwhile to most of us in the profession. I was thinking of posting this to Facebook, but you should.
    This also harks back to Herbert Benson’s article on Placebo Effect in Angina, in the NEJM (1979, 300, 1424-9)

Comments are closed.