Arrhythmias & electrophysiologyCohort study
Outcomes of pulmonary vein isolation with radiofrequency balloon vs. cryoballoon ablation: a multi-centric study
- Prospective cohort study
- multicentre
- 3 European centres
- consecutive patients
Authors' conclusion
The RFB appears to have a safety and efficacy profile similar to that of the CB for PVI. Shorter procedural times appear to be driven by shorter left atrial dwell and thermal delivery times.
Study context
- Population
- Patients with symptomatic drug-resistant paroxysmal atrial fibrillation (AF) undergoing pulmonary vein isolation (PVI), 3 European centres, July 2021–January 2022
- Participants
- 375 patients
- Exposure
- Radiofrequency balloon vs cryoballoon PVI
- Radiofrequency balloon (RFB)n = 125
- Cryoballoon (CB)n = 250reference
- Outcome
- Freedom from atrial tachyarrhythmias
- Follow-up
- 1 year
Main finding
As reported in the abstract
Atrial tachyarrhythmia-free rate · 12.33 ± 4.91 months
P > 0.05
Observational data: associations, not effects.
Further findings
Procedure time
P < 0.001
Dwell time
P = 0.04
Time to isolation and thermal energy delivery in all PVs
- Shorter with RFB than CB
- P < 0.001
First-pass isolation
- Comparable between groups
Safety
Transient phrenic nerve palsy
P = 0.02
events
| Outcome | RFB | CB | P value |
|---|---|---|---|
| Major complications (stroke, atrio-oesophageal fistula, permanent phrenic nerve injury) | 0 | 0 |
- Oesophageal temperature rise (RFB)
- 16.8% · 21 of 125
- Oesophageal temperature rise (RFB) — Gastroscopy erythema, complete recovery after 30 days
- 2
Original publication
Outcomes of pulmonary vein isolation with radiofrequency balloon vs. cryoballoon ablation: a multi-centric study. Europace. Published 6 September 2023. doi:10.1093/europace/euad252
Summarised from the published abstract; every number is checked against it