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.