AF ablation = placebo?

Could Ablation for AF Be an Elaborate Placebo?

John Mandrola, MD

Maybe electrophysiologists are too close to see it: the possibility that ablation of atrial fibrillation is no more effective than a placebo.

Turkish authors boldly raised^[1] this question in a recent editorial in the International Journal of Cardiology. They likened AF ablation to renal denervation, a procedure that promised to transform the treatment of hypertension. That is, until the SYMPLICITY HTN-3^[2]trial showed that renal ablation was no better than a sham procedure. Before the properly controlled trial, nearly all of the data and most of the experts predicted a new era in hypertension. Think about the massiveness of that reversal: millions of people have high blood pressure.

Millions of people also have atrial fibrillation. And, unlike renal ablation, ablation in the left atrium has never been tested against a true placebo. In thousands of reports of AF ablation in the literature, not one is a true test—a sham-controlled study.

I concede that burns (radiofrequency ablation) or freezes (cryoablation) in the left atrium, with the clear end point of electrical isolation of the pulmonary veins, is different from ablation in the renal arteries.

But AF ablation is not just unproven, it's inelegant. This month, almost 2 decades after the first report of AF ablation, German authors called the 2-year results after cryoballoon ablation in patients with persistent AF "promising."^[3] How promising? The procedure failed in 22 of the 50 patients (44%).