Clin Res Cardiol 108, Suppl 2, October 2019
Oesophageal Probe Evaluation in Radiofrequency Ablation of Atrial Fibrillation (OPERA): results from a prospective randomized trial
K. Schöne1, H. Knopp2, A. Weber3, M. Lerche1, S. König1, S. Hilbert4, S. Kircher4, L. Bertagnolli5, A. Arya4, P. Sommer6
1Herzzentrum Leipzig - Universität Leipzig, Leipzig; 2Klinik für Innere Medizin, HELIOS Klinik Leisnig, Leisnig; 3Rhythmologie, KMG Klinikum Güstrow, Güstrow; 4Abt. für Rhythmologie, Herzzentrum Leipzig - Universität Leipzig, Leipzig; 5Klinik für Innere Medizin/Kardiologie, Herzzentrum Leipzig - Universität Leipzig, Leipzig; 6Klinik für Elektrophysiologie/Rhythmologie, Herz- und Diabeteszentrum NRW, Bad Oeynhausen;

Background: The use of oesophageal probes for temperature monitoring during radiofrequency ablation (RFA) for atrial fibrillation (AF) is currently controversially discussed.

Methods: The OPERA study evaluates the impact of oesophageal probes in RFA of AF regarding postinterventional oesophageal complications. 200 patients with indication for AF ablation were prospectively randomised into two groups: the OPERA+ group underwent RFA using an oesophageal probe (SensiThermÔ) to measure the temperature during ablation; the OPERA- group received RFA using fixed energy levels with 25 watts at the posterior left atrial wall without an oesophageal probe. All patients underwent postinterventional endoscopy and a 6 months follow-up including reevaluation of oesophageal complications (primary endpoint) and assessment of rhythm stability (secondary endpoint). Endoscopically detected oesophageal lesions (EDEL) with ≤5 mm are defined as EDEL1 and >5 mm as EDEL2. The study is registered in Clinical.Trials.gov (NCT03246594).

Results: The study flow-chart is depicted in Figure 1. The drop-out rate was 9/100 (9%) vs. 10/100 (10%) mostly due to incidental findings in preinterventional imaging. 10/91 (11%) patients in OPERA+ vs. 8/90 (9%) in OPERA- revealed EDEL after the ablation procedure (p=ns). There was no significant difference in average lesion size: 6.2±3.7 vs. 4.5±1.7 mm (p=0.252). OPERA+ showed 6/10 (60%) EDEL1 and 4/10 (40%) EDEL2 vs. 7/8 (88%) EDEL1 and 1/8 (12%) EDEL2 in OPERA- (p=0.314). No patient in OPERA+ and 1 patient in OPERA- required specific therapy for treatment of the lesion (p=0.444). With 27±2.6 vs. 25±0 watts (p=0.045), there was a significant higher maximal level of radiofrequency energy during ablation at the posterior left atrial wall. The maximum temperature measured by the SensiThermÔ probe during ablation was 40.9±1.3 °C. No patient died. In one patient of OPERA+ the oesophageal probe had to be removed before ablation due to the need of invasive ventilation.

Conclusion: In this prospective randomized study we could demonstrate similar incidence of oesophageal alterations detected in endoscopy in both groups: with and without a temperature probe. If higher ablation energy in the probe group translates into improved outcome of the procedure is currently under investigation.
https://www.abstractserver.com/dgk2019/ht/abstracts//PP154.htm