The Fire and Ice AF ablation clinical trial is the largest, prospective, 1:1 randomized, non-inferiority study (762 patients from 16 sites in 8 countries) that compared the efficacy and safety of PVI using cryoballoon versus radiofrequency (RFC) ablation in patients with paroxysmal atrial fibrillation (PAF).1
Pulmonary vein isolation by means of cryoballoon ablation was non-inferior to pulmonary vein isolation by radiofrequency ablation in terms of efficacy and safety.
Primary effectiveness endpoint met
The cryoballoon met the non-inferiority endpoint and did so with shorter and more consistent procedure times compared to radiofrequency (60%).2
Freedom from primary failure event
Homogeneity test across all groups: p = 0.25
Primary safety endpoint met
The primary safety endpoint was achieved. There was no significant difference between the two methods with regard to overall safety.
Primary safety endpoint
Hazard ratio, 0.78 (95% CI, 0.52–1.18) p = 0.24
Secondary analyses
In a predefined secondary analysis, relative to radiofrequency, the Arctic Front™ cryoballoon demonstrated significant improvements.3
34% fewer cardiovascular hospitalizations
Cryo: 139 events in 89 subjects (89/374; 23.8%)
RFC: 203 events in 135 subjects (135/376; 35.9%)
33% fewer repeat ablations
Cryo: 49 events in 44 subjects (44/374; 11.8%)
RFC: 70 events in 66 subjects (66/376; 17.6%)
Health economics analysis
96% of the total cost savings was due to fewer repeat ablations and atrial fibrillation-related hospitalizations.4
Overall payer costs were significantly lower in the cryoballoon group compared to the radiofrequency group (RFC) across three healthcare systems.
Total cost per patient differences (U.S. CMS perspective)
Trial period payer cost; average follow-up: 18 months
Endpoint definitions
Primary efficacy endpoint
Time to first documented recurrence of AF > 30s/AT/AFL, prescription of AAD, and/or repeat ablation
Primary safety endpoint
Time to first all-cause death, all-cause stroke/TIA or treatment-related serious adverse events (AE)
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Fürnkranz A, Brugada J, Albenque JP, et al. Rationale and design of FIRE AND ICE: a multicenter randomized trial comparing efficacy and safety of pulmonary vein isolation using a cryoballoon versus radiofrequency ablation with 3D-reconstruction. J Cardiovasc Electrophysiol. 2014;25(12):1314–1320. doi: 10.1111/jce.12529.
Kuck KH, Brugada J, Fürnkranz A, et al. Cryoballoon or radiofrequency ablation for paroxysmal atrial fibrillation. N Engl J Med. 2016;374(23):2235–2245. doi: 10.1056/NEJMoa1602014.
Kuck KH, Fürnkranz A, Chun KRJ, et al. Cryoballoon or radiofrequency ablation for symptomatic paroxysmal atrial fibrillation: reintervention, rehospitalization, and quality-of-life outcomes in the FIRE AND ICE trial. Eur Heart J. 2016;37(38):2858–2865. doi: 10.1093/eurheartj/ehw285.
Chun KRJ, Brugada J, Elvan J, et al. The impact of cryoballoon versus radiofrequency ablation for paroxysmal atrial fibrillation on healthcare utilization and costs: an economic analysis from the FIRE AND ICE trial. J Am Heart Assoc. 6(8):e006043. doi: 10.1161/JAHA.117.006043.
Arctic Front Advance Pro™ cardiac cryoablation catheter
Arctic Front Advance™ cardiac cryoablation catheter