A new esophageal safety paradigm in catheter ablation of atrial fibrillation. Does the Pulsed-field ablation induce an esophageal and periesophageal injury?

Background:

The newly introduced pulsed field ablation (PFA) is a promising nonthermal, cardiac tissue selective ablation modality for pulmonary vein isolation (PVI). Recently, high acute success rates and good safety features have been reported. Until now no atrio-esophageal fistula related to PFA has been reported. However, this fatal complication is rare and endoscopically detected esophageal lesions (EDEL) may serve as a more sensitive instrument to document esophageal safety.

Aim of the study:

This study sought to evaluate the esophageal safety of the Farapulse PFA system for PVI.

Methods:

In patients with symptomatic atrial fibrillation (AF), Farapulse PFA-system was used for PVI under propofol sedation. Additional left atrial posterior PFA application was performed in some cases.  Esophageal endoscopy was performed in all patients within 1 day after ablation. Follow up included two systematic follow up visits 3 and 12 months after the procedure. The patients were asked to have two long-term ECGs performed before each visit.

Results:

 The study enrolled 127 consecutive patients with symptomatic AF (74.8 % paroxysmal). The baseline characteristics are shown in Table 1. The patients were relatively young (age 66.27 ± 9.74   years), 34.6 % were of male gender. The mean left ventricular function was normal (60 ± 8 %), and the mean LA diameter was 41 ± 5 mm.

                                                  Table (1)

In 20 patients (16%) a redo procedure was performed after a former cryoballoon (75%) ablation or RF( 25%). Of them in  11 (55%) no Re-PVI was needed. Altogether, 12 patients (9%) received additional posterior wall ablation. The procedural characteristics are shown in Table 2. All pulmonary veins could be successfully isolated .The procedure time was 65 ± 11 min,  fluoroscopy duration 9  ± 3 min, and the median dose area product was 599  ± 441.9 cGy cm² . Procedural complications included one AV fistula without necessary intervention and two minor hematomas.  No stroke, pericardial tamponade or phrenic nerve alteration occurred. In none of the patients EDEL were detected.  Follow up results will be finalized until presentation.

                                                                              Table 2  Procedure characteristics


Conclusions:

PVI using PFA for atrial fibrillation appears to be a very safe and effective. There is no collateral damage to the phrenic nerve or the oesophagus.