Dr Atul Verma (Southlake Regional Health Center, Toronto, ON, CA) on behalf of the PULSED AF Investigators shares the results of a study measuring the safety and effectiveness of the novel Pulsed Field Ablation (PFA) technology.
Question 1: What technology was used in this study and how does it differ to point-to-point pulsed ablations?
[Verma] It was a pleasure to present the PULSED AF trial at HRS Late-Breaking. What differentiates this technology from traditional point-to-point radio frequency is that it is called pulsed field ablation or irreversible electroporation. So instead of using thermal energy, like heat or freezing, we are using electrical fields and when we expose them to the tissue, that opens up pores in the cells, which then leads to targeted cell death. So this is a non-thermal ablation. And we think that this will offer many advantages over traditional point-to-point radio frequency.
Question 2: What was the design of the trial?
[Verma] So the data that we're presenting for the PULSED AF trial are essentially the initial acute results of the trial. So we were meant to evaluate 20 patients but we reported on 14 because the other six cases were differed because of the COVID-19 crisis. But what we've showed was essentially the primary safety endpoint, which is whether there were any safety issues within the first 30 days and the primary acute efficacy endpoint, which was the ability to isolate the pulmonary veins using the pulse field ablation only and no other technologies.
Question 3: What did the data show?
[Verma] I'm proud to say that when it came to safety, we certainly had no seriously adverse events reported thus far in the trial. In particular, we think that pulse field ablation will have a better safety profile when it comes to phrenic nerve injury or esophageal injury, and certainly we saw no change in the esophageal temperature in the patients. And we also so no phrenic nerve injury and there were no other serious adverse events reported at 30 days. And for the acute efficacy endpoint, we were able to isolate a 100% of the pulmonary veins in the 14 patients using pulse field ablation alone and no other technologies.
Question 4: What further research should be conducted with this technology?
[Verma] So obviously, there is further research that needs to be conducted with pulse field ablation. First of all, we're going to be following all of these patients out to one year and we will be reporting at on one year efficacy and safety endpoints. Furthermore, we obviously need a larger trial with more numbers of patients. This was just a first in human feasibility trial and we hope to be moving into a much larger pivotal trial very, very soon.