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2021 AF Symposium
Pulsed Field Ablation Using Multielectrode Catheters and PFA Compared to RF Study
Note: At last year’s AF Symposium, the term “Pulsed Field Ablation” (PFA) was used. This year Dr. Jais used the phrase “Pulsed Electrical Field ablation” (PEF).
Pierre Jaïs, MD, The Bordeaux Group
Presenter: Dr. Pierre Jais of the French Bordeaux Group (LIRYC)
Topic 1: “Pulsed Electric Field Ablation and the Multielectrode Basket/Flower Array for Paroxysmal and Persistent AF”.
Farapulse catheter: Five Petal Flower Configuration
Background: Dr. Pierre Jais first explained how Farapulse, Inc. developed Pulsed Electric Field Ablation (PEF) by pre-clinically testing it on 700 swine to improve the device, delivery design, the generator, the catheters, to demonstrate safety, and the absence of unwanted lesions.
Testing on 121 paroxysmal patients: Next, he discussed recent human testing on 121 patients with paroxysmal Atrial Fibrillation at 3 different European centers . With 5 different operators, procedure times were about 1 hour with 35 minutes of LA dwell time. They used 20 minutes of mapping which is not required in routine practice.
Results: They had 4 (non-serious) adverse events with no phrenic nerve damage, PV stenosis, stroke, or infarction. At 3 months they had a 96% success rate of durable PVI.
The PEF catheter does not require actual physical contact but only needs proximity to the tissue to be ablated. And it doesn’t cause scarring or char formation.
What is Pulsed Electric Field Ablation? PEF is a non-thermal energy system that uses a series of ultra-short electrical pulses to ablate heart tissue in seconds. More importantly, PEF works on the selected cell types while leaving others alone (like the esophagus).
Topic 2: The BEAT AF Study: PEF Compared to RF
According to Dr. Jais, one of the most important questions facing researchers: “Is Pulsed Electrical Field ablation (PEF) indeed better than standard RF ablation?”
Farapulse open basket catheter configuration
From all the previous preliminary research on PEF, one would assume PEF is better than standard RF ablation. [See 2020 AF Symposium: Pulsed Field Ablation—Emerging Tech for Atrial Fibrillation] But answering a question this important can’t be assumed.
Dr Jais discussed the BEAT AF randomized five-year study. It will attempt to demonstrate that isolation of the Pulmonary Veins (PVs) by Pulsed Electrical Field ablation is more effective, faster, and safer than Radiofrequency (RF) ablation (the current standard or reference ablation treatment). It will involve 10 European centers.
Editor’s Comments:
BEAT AF Randomized Five-year Study: Normally I don’t discuss studies until the results have come out. But PEF is different. Pulsed Electrical Field ablation is a new technology that offers a real hope of a revolutionary, break-through strategy to cure A-Fib.
Even though PEF is not yet FDA approved, its potential is incredible and a real game changer both for doctors and patients.
If you find any errors on this page, email us. Y Last updated: Friday, March 12, 2021
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