Atrial fibrillation (AF) is considered one of the major health problems in Western societies, with a prevalence of more than 10% of the population older than 65 years in Europe and North America. Approximately 100,000 catheter ablations are performed annually in German hospitals, according to data provided by the German Cardiac Society. Until 2021, standard methods for cardiac ablation included radiofrequency ablation and cryoballoon ablation. Despite their effectiveness, these methods are associated in a small number of cases with major and potentially life-threatening complications such as esophageal injury and atrio-esophageal fistulas. Since its first certification in 2021, pulsed field ablation (PFA) has demonstrated an improved safety profile in this regard. To date, no esophageal injuries or atrio-esophageal fistulas have been reported, likely due to the highly tissue-selective, non-thermal mechanism of irreversible electroporation by which PFA achieves myocardial ablation.  However, animal models have demonstrated potential injury to the esophageal muscular layers after PFA, presumably due to the close anatomical proximity of the esophagus to the left atrium. To date, no clinical studies investigating a potential association between PFA and esophageal motility disorders have been conducted. Therefore, we performed a prospective study using high-resolution manometry (HRM) to address this unanswered question.

We conducted a prospective observational cohort study including patients with AF referred to the electrophysiology outpatient clinic of the Alfried Krupp Hospital in Essen, Germany, who were scheduled for PFA from March 2024 until the time of submission. Each participant underwent HRM in our Gastroenterology Department one day before and one day after PFA. HRM was performed according to the Chicago Classification v4.0 for esophageal motility disorders, including ten swallows in the semi-recumbent and five swallows in the sitting position. Participants were also evaluated for dysphagia, and the Eckardt Score was calculated for each individual before and after PFA. The primary endpoint was the change in HRM parameters based on the Chicago Classification v4.0, specifically the mean integrated relaxation pressure (IRP), mean distal contractile integral (DCI), mean distal latency (DL), and mean intrabolus pressure (IBP) before and after PFA. Patients who showed significantly altered manometric parameters after PFA underwent repeat HRM three months later. Secondary endpoints included the persistence or resolution of altered HRM findings at the three-month follow-up, patient-reported dysphagia and changes in the Eckardt Score before PFA, directly after and at the three-month follow-up.

From March 2024 until submission, 40 of the planned 50 patients were enrolled in the study, and 11 patients had completed the three-month follow-up. Eight patients were lost to follow-up. In the remaining patients, no significant long-term differences in manometric parameters were observed after PFA. The mean age of the participants was 68.4 years, and 70% were male. A significant reduction in DCI was observed one day after PFA in both the supine (p = 0.01) and sitting positions (p < 0.0005). The mean DCI decreased by approximately 25.4% in the supine and 38.4% in the sitting position, with a maximal DCI-reduction of 87.5% in one individual. Approximately 55% (22/40) of the patients developed focal areas of reduced pressure in the distal third of the tubular esophagus. Among the patients who completed the three-month follow-up, DCI values had returned to baseline, despite the transient reduction observed at day one . However, five participants still exhibited focal areas of reduced esophageal pressure in isolated swallows at three months. No changes in patient-reported symptoms or Eckardt Scores were detected at any time point.

Patients undergoing PFA may develop transient reductions in esophageal motility one day after the procedure. These alterations largely resolve within three months and appear to have no clinical impact on symptoms. However, the presence of persistent focal pressure abnormalities in a subset of patients suggests subtle long-term motility effects of PFA, highlighting the need for additional research.