Arrhythmias & electrophysiologyCohort study
Novel or established cryoballoon ablation system for pulmonary vein isolation: the prospective ICE-AGE-1 study
- Prospective cohort study
- historical control
- consecutive patients
Authors' conclusion
The novel POLARx CB showed similar safety, efficacy, and 1-year recurrence-free survival rates compared to the AF-CB4. A higher rate of real-time electrical PV recordings and significantly lower balloon temperatures were observed using the POLARx as compared to AF-CB4.
Study context
- Population
- Patients with paroxysmal or persistent atrial fibrillation (AF) undergoing cryoballoon PVI
- Participants
- 103 vs 102
- Exposure
- POLARx cryoballoon vs Arctic Front Advance Pro cryoballoon for PVI
- POLARxn = 103
- AF-CB4n = 102reference
Main finding
As reported in the abstract
Freedom from AF or atrial tachycardia recurrence (after 90-day blanking) · 12 months
P = 0.804
Observational data: associations, not effects.
Further findings
Real-time PVI visualised (% of PVs)
P < 0.001
Mean procedure time
P = 0.0509
| Outcome | POLARx | AF-CB4 | P value |
|---|---|---|---|
| Mean minimal CB temperature | mean −56.1 (SD 8.3) °C | mean −46.9 (SD 10.1) °C | P < 0.0001 |
Pulmonary vein (PV) isolation
- All PVs isolated except one PV in the POLARx group
Original publication
Novel or established cryoballoon ablation system for pulmonary vein isolation: the prospective ICE-AGE-1 study. Europace. Published 17 August 2023. doi:10.1093/europace/euad248
Summarised from the published abstract; every number is checked against it