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2025 AF Symposium
Nanosecond Pulse Field Ablation: First Human Trial
In conjunction with Dr. Neuzil’s Live Case Transmission (Session 6) presentation, Dr. Vivek Reddy, Director of Electrophysiology for the Mount Sinai Health System, gave a talk on “Pulse Field Ablation (PFA) Using a Compliant Circular Catheter Delivering Nanosecond Pulses to Treat Atrial Fibrillation.”
Microsecond vs Nanosecond Pulses
Dr. Vivek Reddy
Dr. Reddy pointed out that all current Pulsed Field Ablation (PFA) systems employ microsecond pulses, “but sometimes you run up against a thermal limit to what you can deliver (with microsecond PFA pulses), and sometimes you go a little beyond that.”
But nanosecond PFA has less thermal effect because the PFA pulses are shorter and larger in amplitude. This allows the Nanosecond PFA system to deliver more energy and create deeper lesions in a shorter time.
First-In-Human Trial of Nanosecond PFA System
Dr. Reddy described the first-in-human trial of the Pulse Biosciences Nanosecond PFA system designed to assess its feasibility, safety and lesion durability.
Pulse Biosciences’ CellFX nsPFA 360° Cardiac Catheter
This trial was done in Prague, CZ using the Pulse Biosciences’ CellFX nsPFA 360° Cardiac Catheter. In this bipolar catheter, energy is delivered between the inner and outer catheter rings in a ring-like or doughnut (a toroidol) pattern.
There are ten recording small electrodes on the periphery of the two rings for electrical mapping. The catheter is very flexible, soft, and conforms to the patient’s anatomy.
Trial Parameters
Nanosecond PFA Ablation trial mapping system
The trial included 30 patients. All were on Direct Oral Anticoagulants (DOACs).
The time from diagnosis to enrollment in this trial was around 1.7 years. 60% had hypertension. All were under general anesthesia (though now they use deep sedation).
Each lesion was 5 seconds (though now they use 2.5 second PFA pulses). The procedures took around 88 minutes. In follow-up, there was an 8% re-connection rate.
Trial Results
There was 100% success in isolating all Pulmonary Veins with 100% durability.
Two-thirds of the patients also had PFA energy applied to their posterior wall with 100% durability. A single mitral isthmus line was created in each posterior wall.
There was one instance of cardiac perforation which was fixed. There were no other problems. There was no esophageal fistula or PV stenosis.
Dr. Reddy’s Level of Excitement “Very High”
In a later Symposium panel discussion, Dr. Reddy was asked about what he thought of Nanosecond PFA. He said his level of excitement was very high. He especially liked how fast the system worked, that he didn’t get physically tired as with other systems that took longer.
There were microbubbles, but because they were in the Nanosecond range, he didn’t think they would be a problem.
Editor’s Comments
Editor’s CommentsAs an energy source, pulsed field ablation (PFA) has generated tremendous excitement for A-Fib treatment, largely due to its safety benefits.
First-In-Human Trial Small But Great Results: The first-in-human trial of Nanosecond PFA, though small, certainly demonstrated its safety, efficacy, and lesion durability.
Nanosecond PFA increases the amplitude of the PFA pulse while lowering its duration. Lesions are better and deeper, while there is less chance of damage to adjacent heart tissue. (Pulse Field Ablation has already proven to be effective and safe compared to RF.) But more research into Nanosecond PFA needs to be done to confirm these preliminary findings.
Nanosecond PFA Ablation Significant Improvement: It seems like Nanosecond Pulse Field Ablation (Pulse Biosciences, Inc.) is or will become a significant improvement in Pulse Field Ablation, which is already recognized as a very effective treatment for patients.
Nanosecond PFA represents the next generation of energy that will improve the safety, results and efficiency of A-Fib ablation.
