One-year follow-up after pulmonary vein isolation using pulsed field ablation for paroxysmal atrial fibrillation
Authors: Neven K , Fueting A , Hartl S , Reinsch N 
Published: May 2023

Abstract

Funding Acknowledgements
Type of funding sources: None.

Background
Pulsed field ablation (PFA) has recently been introduced as a novel routine ablation technology for paroxysmal atrial fibrillation (PAF). Only a few small clinical studies have been published on the mid- and long-term outcome. Here, we present the one-year clinical outcomes of PFA in PAF.

Methods
In PAF patients, PVI in conscious sedation using a steerable sheath and a pentaspline over-the-wire basket and flower PFA catheter was performed. In a subset of patients, pre- and post-ablation high-density bipolar voltage 3D maps using a pentaspline diagnostic cathter were performed. Procedural parameters, acute success, in-hospital safety and arrhythmia recurrence were assessed during one-year follow-up. Efficacy was evaluated by freedom from a ≥ 30-sec. recurrence of AF/atrial flutter (AFL)/atrial tachycardia (AT). Follow-up included 7-day Holter ECGs and/or telephonic interviews at days 90, 180 and 360 days after ablation.

Results
This study included a total of 108 patients (mean age 65±10 years; 44% female). Mean CHA2DS2-VASc-score was 2,3±1,7. Mean duration since first AF diagnosis was 45±63 months. Pre- and post-ablation high-density maps were performed in 36/108 (33%) of patients. Skin-to skin procedure time was 78±36 min. Fluoroscopy time and dose area product were 19±8 min and 5,56±4,64 Gy.cm2, respectively. Left atrial dwell time of the PFA catheter was 27±11 min. Acute PVI rate was 100% of PVs using PFA only. Primary adverse events occurred in 3,7% of patients (1 groin hematoma, 2 pericardial tamponades, 1 acute stroke with lethal outcome). No patients were lost during FU. During a mean FU of 346±64 days, 88 of 107 patients (82%) remained free of any symptomatic or documented AF/AFL/AT episode after a single procedure. After the 90-day blanking period, in 19 (18%) patients at least one episode of AF/AFL/AT was documented. In 14/107 (13%) patients, after 216±102 days a re-do procedure was performed. In 7/107 (7%) patients, PV reconduction was seen. In 5/107 (5%) patients, during re-do procedure clinical or induced typical or atypical flutter was treated in presence of durable PV isolation. In the remaining 2/107 (2%) patients, only clinical right atrial typical flutter was treated and no left atrial mapping was performed.

Conclusions
PVI using PFA in patients with a relatively long history of PAF results in a low one-year atrial arrhythmia recurrence rate. The success rate may be reduced due to the long duration since first AF diagnosis and the initial experience with PFA by the operators. PV reconduction rate during re-do procedure in a limited number of patients was 7%. There was a reasonable safety profile and it improved significantly over the course of time, indicating that the learning curve could have negatively influenced the incidence of complications.
Figure: Kaplan-Meier analysis of freedom from atrial arrhythmias, including any AF/AFL/AT episode exceeding 30 sec. Not including the 3-month blanking period.