John M. Mandrola, MD; Felipe Atienza, MD, PhD


February 10, 2014

In This Article

Not Entirely Negative

Dr. Mandrola: Some of the initial reports -- I don't agree with them -- were that the trial was negative, but this isn't the case, is it?

Dr. Atienza: This is not the case. For patients with persistent atrial fibrillation, the trial was negative in the sense that we were not able to demonstrate the superiority of the combined approach compared with the CPVI-only ablation approach, but in patients with paroxysmal atrial fibrillation, we were able to demonstrate that the HFSA-only strategy was as efficacious as the CPVI strategy -- that is, noninferior -- and was significant at 1 year. At the same time, patients assigned to the HFSA strategy had fewer complications than patients undergoing CPVI.

Dr. Mandrola: It makes sense that they had fewer complications because they had less ablation. Do you agree with this?

Dr. Atienza: Completely. We observed that the more radiofrequency that was delivered and the longer the procedure, the higher the rate of complications.

Dr. Mandrola: If you can get similar efficacy with less ablation and focal ablation, this is pretty exciting.

Dr. Atienza: It is.

Dr. Mandrola: I'm intrigued by the high-frequency source determination. Exactly how do you do this? Is it difficult?

Dr. Atienza: It's time-consuming, in the sense that it takes approximately 30 minutes of the overall procedure to obtain 5- second recordings for every sprout in both the atrial and the coronary sinuses, and after that you have to review every single point to make sure that it has been properly measured by the algorithm of the navigation system.

Dr. Mandrola: Does the computer do this?

Dr. Atienza: The computer does it, but it has to be reviewed by the operator.

Dr. Mandrola: How do you determine which sites to look at?

Dr. Atienza: It's the site that is activating faster compared with the surrounding tissue.

Dr. Mandrola: Can you tell us about the redo procedure for paroxysmal atrial fibrillation?

Dr. Atienza: In both groups, redo procedures were performed at a similar rate. Approximately 25% of the patients (both those with paroxysmal and those with persistent atrial fibrillation) underwent a redo procedure. According to protocol, patients undergoing a redo procedure were assigned the same strategy as the index procedure.

Dr. Mandrola: So when you took patients back, you didn't do CPVI.

Dr. Atienza: All patients with paroxysmal atrial fibrillation underwent HFSA in the redo procedure.

Dr. Mandrola: You have an overall success rate of about two thirds in paroxysmal atrial fibrillation group who received HFSA without isolating the pulmonary veins.

Dr. Atienza: A median of 2.22 veins were isolated in the HFSA group, compared with a median of 3.73 in the CPVI group, which is a highly significant difference.


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