Lessons learned from the first in human sequential colocalized PFA and RF lesions

Area of Science:

• Cardiovascular Medicine
• Electrophysiology
• Medical Devices

Background:

• Pulsed field ablation (PFA) offers enhanced safety for atrial fibrillation treatment.
• First-generation PFA has limitations in ablating heterogeneous cardiac tissue beyond pulmonary veins due to fixed electrical field parameters.
• Radiofrequency (RF) ablation provides deeper lesion penetration but carries higher risks.

Purpose of the Study:

• To evaluate the feasibility and safety of sequential, colocalized PFA and RF ablation.
• To assess the potential of combining PFA and RF ablation for treating complex atrial fibrillation substrates.
• To report the first human experience using a novel dual energy catheter for sequential ablation.

Main Methods:

• Utilized an investigational 3.5-mm dual energy catheter.
• Performed sequential, colocalized pulsed field ablation and radiofrequency ablation lesions in human subjects.
• Focused on challenging substrates with heterogeneous tissue thickness.

Main Results:

• Successfully delivered sequential colocalized PFA and RF lesions.
• Demonstrated the potential for safe and deeper lesion creation in challenging cardiac substrates.
• Marked the first human application of this combined ablation technique.

Conclusions:

• Sequential colocalized PFA and RF ablation is feasible in humans.
• This combined approach may overcome limitations of PFA alone for complex atrial fibrillation ablation.
• Further investigation is warranted to establish the full clinical utility of this dual energy catheter system.