Arrhythmias & electrophysiology
Efficacy and safety in patients treated with a novel radiofrequency balloon: a two centres experience from the AURORA collaboration
Authors' conclusion
The RFB showed a high efficacy allowing for fast PVI procedures, and 60% of PVs could be isolated at the first application. Most safety events were recorded during the learning phase.
Study context
- Population
- Consecutive patients undergoing radiofrequency (RF) balloon pulmonary vein (PV) isolation at two high-volume German centres (57% paroxysmal AF)
- Participants
- 140 patients547 PVs
- Outcome
- Procedural efficacy and safety of RFB-PVI
Methodological detailstwo-centre, consecutive patients, pooled data
- Two-centre
- Consecutive patients
- Pooled data
Main finding
As reported in the abstract
Procedural efficacy
- PVs isolated using solely the RFB
- 99.1%
- Single-shot PVI (PVs)
- 330/547 (60%)
- Median time to isolation, first application
- 10 s (IQR 8-13)
- Applications per PV (mean ± SD)
- 2.1 ± 1.8
- Median procedure time
- 77 min (61-99)
- Median fluoroscopy time
- 13 min (10-17)
Observational data: associations, not effects.
Safety
Major safety events
- Cardiac tamponade
- 1/140(0.7%)
- Phrenic nerve palsy
- 1/140(0.7%)
- Stroke
- 2/140 (1.4%)
- Recorded only in the first 25 cases at each centre
Oesophageal effects · endoscopy <48 h
- Oesophageal temperature rise (PVs)
- 81/547 (15%)
- Oesophageal lesions on endoscopy (patients)
- 7/85 (8%)
Original publication
Efficacy and safety in patients treated with a novel radiofrequency balloon: a two centres experience from the AURORA collaboration. Europace. Published 28 April 2023. doi:10. 1093/ europace/ euad106
Composed by AI from the published abstract and checked against it. How Briefs are made →