Background:
Dual Energy ablation (Radio frequence ablation //RF// and pulsed field ablation //PFA//) is a new ablation modality for pulmonary vein isolation (PVI) that has the potential to enable electrophysiologists to eliminate the need to exchange catheters and allow them to seamlessly switch the energy source, whether RF or PF, based on patient needs.
Compelling acute and longterm success rates and good safety features have been reported using a pentaspline PFA catheter. Thus far, no atrio-oesophageal fistula (AEF) related to PFA has been reported.
This study aimed to evaluate the safety of THERMOCOOL SMARTTOUCH™ SF Dual Energy Catheter by systematically using upper endoscopy post-ablation in a large, single centre cohort .
Methods:
Patients with symptomatic atrial fibrillation (AF) underwent PVI using the dual energy ablation system. All patients underwent oesophageal endoscopy within one day post-ablation. Follow-up visits occurred three and 12 months post-procedure. The patients had 48h-Holter monitoring performed before each visit.
Results:
Consecutive, symptomatic AF patients (n=50, 84% paroxysmal) were enrolled. The patients were relatively young (age 61±12,1 years), 76 % male, and had a normal, mean left ventricular function was normal 58 ±7%. Mean left atrial diameter was 39±3 mm. All PV were successfully isolated. The procedure time was 110 ±13 min, fluoroscopy duration 5±3 min, and the median dose area product was 458 ± 210 cGy cm2. Major procedural complications were only one 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 (10%) cases.
However, no patient oft he five patients with gastroparesis had diabetes mellitus with autonomic neuropathy. All five patients were contacted by phone one week after the pulsed field ablation. None of them reported any further symptoms.
Conclusions:
The lack of EDEL post-PVI using the dual energy ablation-catheter in this AF cohort highlights the esophageal safety of this method. Gastroparesis was observed in 5 patients (10 %).