A Comparative Analysis of Long-Term Procedural Outcomes Following Circular Array Pulsed Field and Radiofrequency...

Area of Science:

• Cardiovascular Medicine
• Electrophysiology
• Medical Devices

Background:

• The circular array (CA) pulsed field ablation (PFA) system is the first FDA-approved PFA technology for atrial fibrillation (AF).
• Real-world long-term outcome data for CA PFA are limited.
• This study addresses the need for comparative outcome data.

Purpose of the Study:

• To compare 1-year procedural outcomes and arrhythmia recurrence.
• CA PFA versus clinically matched radiofrequency (RF) ablation for de novo AF ablation.
• Evaluate the safety and efficacy of CA PFA in a real-world setting.

Main Methods:

• Prospective single-center study of 36 consecutive patients undergoing de novo AF ablation with CA PFA.
• 1:1 matching with RF ablation controls based on key demographic and clinical factors.
• Primary endpoint: composite of AF recurrence, antiarrhythmic drug use, cardioversion, or repeat ablation at 1 year.

Main Results:

• Shorter procedure and left atrial dwell times for CA PFA (124 vs. 179 min; 72 vs. 115 min; p < 0.001).
• No complications in the PFA group versus two access-site hematomas in the RF group.
• The composite endpoint occurred less often with PFA (22% vs. 36%, p = 0.195), with PFA associated with a lower recurrence risk (aOR: 0.50, p = 0.081).

Conclusions:

• CA PFA, with lesion optimization, is safe, efficient, and as effective as RF ablation at 1 year.
• This study provides the first controlled, real-world comparison of long-term outcomes between CA PFA and RF ablation.
• CA PFA demonstrates promising outcomes for AF treatment.