Gastroparesis as a potential complication of pentaspline pulsed field ablation without endoscopic esophageal injury

BackgroundPulsed field ablation (PFA) is a new nonthermal, ablation modality for pulmonary vein isolation (PVI) that is cardiac tissue selective. Compelling acute and long-term success rates and good safety features have been reported using a pentaspline PFA catheter. Thus far, no atrio-esophageal fistula (AEF) 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.This study aimed to evaluate the esophageal safety of the Farapulse (TM) PFA system by systematically using upper endoscopy post-ablation in a large, single-center cohort.BackgroundPulsed field ablation (PFA) is a new nonthermal, ablation modality for pulmonary vein isolation (PVI) that is cardiac tissue selective. Compelling acute and long-term success rates and good safety features have been reported using a pentaspline PFA catheter. Thus far, no atrio-esophageal fistula (AEF) 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.This study aimed to evaluate the esophageal safety of the Farapulse (TM) PFA system by systematically using upper endoscopy post-ablation in a large, single-center cohort.MethodsPatients with symptomatic atrial fibrillation (AF) underwent PVI using the pentaspline PFA system. Additional left atrial posterior PFA application was used in some cases. All patients underwent esophageal endoscopy within 1 day post-ablation. Follow-up visits occurred 3 and 12 months post-procedure. The patients had 48 h-Holter monitoring performed before each visit.ResultsConsecutive, symptomatic AF patients (n = 228, 87.6% paroxysmal) were enrolled. The patients were relatively young (age 59.4 +/- 11.7 years), 67.4% male, and had a normal mean left ventricular function of 60 +/- 8%. Mean left atrial diameter was 41 +/- 4 mm. All PVs were successfully isolated. The procedure time was 55 +/- 11 min, fluoroscopy duration was 7 +/- 3 min, and the median dose area product was 563 +/- 410 cGy cm2. Major procedural complications were only two AV fistula, which did not require intervention. No stroke, pericardial tamponade, or phrenic nerve damage occurred. EDEL were not detected in any patient. Gastroparesis occurred in nine (4%) cases.ConclusionsThe lack of EDEL post-PVI using the pentaspline PFA-catheter in this large AF cohort highlights the esophageal safety of this method. Gastroparesis was observed in a small minority, but relationship with PFA is still to be determined.