According to the Heart Rhythm Society, up to 16 million Americans will have atrial fibrillation (AFib), the most common type of arrhythmia, by 2050. Ablation of AFib continues to evolve, and we are reaching a turning point in the field of electrophysiology. It is fascinating to be a part of it.
What is changing in Atrial Fibrillation treatment?
Atrial fibrillation ablation has become the cornerstone for the treatment of atrial fibrillation. During this procedure, we target the pulmonary veins and other areas that can trigger AFib. The tools commonly used until now rely on thermal energy to deliver the ablation – either heating (radiofrequency) or cooling (cryo). These technologies have proven effectiveness, but by burning or freezing the tissue, we have small risks of complications due to damage to collateral tissues.
And now, we’re moving towards a new era in atrial fibrillation ablation: Pulsed Field Ablation (PFA). PFA is a new ablation technology where a very fast pulse of electricity is delivered, leading to the ablation of the heart tissue targeted. This technology offers many advantages:
- This energy modality is selective to heart tissue and does not significantly increase the temperature. This means that even when ablating tissue that is in close proximity to other structures, the chances of damage are very low.
- The energy delivery is fast which can reduce the procedure time.
- PFA can be delivered via different catheters that have been either custom-built or repurposed for this use. This may pace the way for developing technologies and workflows that result in easier and more reproducible ablation.
PFA was approved in Europe several years ago, where tens of thousands of procedures have already been completed. In the US, several clinical trials have been completed or are ongoing. Some trials have already been published and led to the recent approval of two PFA technologies.
A few trials have completed enrollment, and some are currently enrolling patients. There are several new technologies expected to be under investigation soon.
So, what is my opinion on PFA?
Considering the published data from clinical trials and real-world evidence (from Europe), I believe that PFA will change the landscape in AFib ablation!
In my opinion, the most important findings from the published studies that should be highlighted are:
- PFA is safe. Although not free from its own risks and procedural-related complications, PFA seems to be the solution to eliminate esophageal injury (which has not been reported in the European experience).
- PFA is efficient. Real-world procedure times have been shorter. Shorter procedure times and preparation times should improve safety and also our ability to treat more patients in the same specialized area in the hospital – the EP Lab.
- PFA is at least as effective as the current technology but because of its ease of use, may become a more effective solution.
- PFA may make it simpler to standardize the procedure and have more uniform results across multiple centers and physicians.
Although, at face value, one may think that the results of these studies are not spectacular, I think we should all consider carefully how impressive this technology really could be. Catheter ablation has been around for several decades, and the physicians who participated in the PFA trials are some of the most experienced in the world. PFA was a new technology, and doctors were immediately able to deliver ablation that was at least as effective but faster and safer in many ways. Further real-world studies have shown very short learning curves, or the number of procedures it takes a physician to achieve optimal results with a new tool or technique, and even shorter procedure times. Therefore, even though a brand-new technology was being tested, the results were quite good, and some clear advantages were identified.
In summary, PFA will change the landscape of AFib ablation. The technology will advance fast, ushering in a new era in AFib care. I hope that real-world results with the recently and soon-to-be-approved technologies in the US will mirror what was seen in Europe and that we will quickly learn how to improve them by leveraging data collection and collaboration!
Dr Jose Osorio
Miami, FL
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