Pulsed Field Ablation Treatment In Paroxysmal And Persistent Atrial Fibrillation Patients: Acute And Long-term Outcomes From The Pulsed Af Pivotal Trial

Dr. Cansu Öztürk

Published in Congress: ACC 2023

Link: https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.123.063988

Background:
Pulsed field ablation uses electrical pulses that cause nonthermal irreversible electroporation and induction of cardiac cell death. Because pulsed field ablation is a nonthermal method, study compared this method to conventional catheter ablation, while protecting it from thermal related complications.

Objective:
The use of pulsed field ablation as a treatment option in patients with paroxysmal and persistent AF and evaluation of its results.

Methods:
The PULSED AF pivotal study was designed as a prospective, global, multicenter, nonrandomized, paired single-arm study. Patients with paroxysmal (n=150) or persistent (n=150) symptomatic atrial fibrillation (AF) resistant to class 1 or 3 antiarrhythmic drugs have been treated with pulsed field ablation. All patients were followed for 1 year with 3, 6, and 12-month ECGs using weekly and symptomatic transtelephonic monitoring, and 24-hour Holter monitoring at 6 and 12 months. trial primary efficacy endpoint was the absence of acute procedural failure, arrhythmia recurrence, or antiarrhythmic escalation for 12 months, except for the first three months after the procedure to allow for recovery. The primary safety endpoint was the absence of serious procedural and device related adverse events. Kaplan-Meier methods were used to evaluate the primary end points.

Results:
Pulsed field ablation was shown to be effective at 1 year in 66.2% (95% CI, 57.9 to 73.2) of patients with paroxysmal AF and 55.1% (95% CI, 46.7 to 62.7) of patients with persistent AF. The primary safety end point occurred in 1 patient (0.7%; 95% CI, 0.1 to 4.6) in both the paroxysmal and persistent AF cohorts.

Conclusion:
PULSED AF showed a low rate (0.7%) of primary safety adverse events. It also provided similar efficacy with traditional ablation techniques as a new technology using irreversible electroporation energy in the treatment of AF patients.

Interpretations:
The PULSED AF pivot study showed that pulsed field ablation was successful in treating AF for 12 months in two-thirds of patients. The limitation of the study is the absence of a control group. In addition, larger studies are needed to obtain more conclusive evidence of the safety of the technique. In contrast, the fact that this nonthermal ablation technique takes less than an hour for most procedures may mean that this technique is significantly faster and safer than thermal ablation techniques.