Oesophageal Probe Evaluation in Radiofrequency Ablation of Atrial Fibrillation (OPERA): results from a prospective randomized trial.

AIMS: The aim of the study was to determine the incidence of oesophageal lesions after radiofrequency ablation (RFA) of atrial fibrillation (AF) with or without the use of oesophageal temperature probes. METHODS AND
RESULTS: Two hundred patients were prospectively randomized into two groups: the OPERA+ group underwent RFA using oesophageal probes (SensiTherm™); the OPERA- group received RFA using fixed energy levels of 25 W at the posterior wall without an oesophageal probe. All patients underwent post-interventional endoscopy and Holter-electrocardiogram after 6 months. (Clinical.Trials.gov: NCT03246594). One hundred patients were randomized in OPERA+ and 100 patients in OPERA-. The drop-out rate was 10%. In total, 18/180 (10%) patients developed endoscopically diagnosed oesophageal lesions (EDEL). There was no difference between the groups with 10/90 (11%) EDEL in OPERA+ vs. 8/90 (9%) in OPERA- (P = 0.62). Despite the higher power delivered at the posterior wall in OPERA+ [28 ± 4 vs. 25 ± 2 W (P = 0.001)], the average EDEL size was equal [5.7 ± 2.6 vs. 4.5 ± 1.7 mm (P = 0.38)]. The peak temperature did not correlate with EDEL size. During follow-up, no patient died. Only one patient in OPERA- required a specific therapy for treatment of the lesion. Cumulative AF recurrence after 6 (3-13) months was 28/87 (32%) vs. 34/88 (39%), P = 0.541.
CONCLUSION: This first randomized study demonstrates that intraoesophageal temperature monitoring using the SensiTherm™ probe does not affect the probability of developing EDEL. The peak temperature measured by the thermoprobe seems not to correlate with the incidence of EDEL. Empiric energy reduction at the posterior wall did not affect the efficacy of the procedure. Published on behalf of the European Society of Cardiology. All rights reserved.

RCT Entities:   Population Interventions Outcomes