Arrhythmias & electrophysiology

Efficacy and safety in patients treated with a novel radiofrequency balloon: a two centres experience from the AURORA collaboration

EuropacePublished Observational cohort study

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

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