Reduce Costs And Improve Outcomes

Risks associated with atrial fibrillation

If left untreated, the side effects of atrial fibrillation (AF) can be life threatening. AF is associated with the following burden and set of risks:

  • 2x increased risk of death overall and a 9x increased risk of death within 4 months after the first AF diagnosis1
  • 5x increased risk of stroke2
  • Increased risk of heart failure and sudden cardiac death3,4
  • Negative impact on energy level, physical activity, and overall quality of life5

Reducing Total Cost of Care

The FIRE AND ICE AF Ablation Clinical Trial is the largest, prospective, 1:1 randomised, non-inferiority study  (762 patients from 16 sites in 8 countries) that compared the efficacy and safety of PVI using cryoballoon versus point-by-point radiofrequency (RF) ablation with the CARTO® 3D mapping system in patients with paroxysmal atrial fibrillation (PAF).

Cryoballoon met the non-inferiority endpoint and did so with shorter and more consistent procedure times compared to radiofrequency.

The FIRE AND ICE secondary analysis demonstrated that Cryoballoon ablations were associated with 33% fewer repeat ablations, 21% fewer cardiovascular hospitalisations, and 50% fewer cardioversions compared to RF ablation. This can result in an improved patient experience and a lower cost of care per patient.

Pulmonary vein isolation using cryoballoon resulted in decreased atrial fibrillation healthcare disease burden and symptoms and fewer reinterventions, with significant clinical and economic impact. 6



Improve Outcomes with Early Treatment

AF is progressive in nature. Paroxysmal AF develops into persistent AF at an overall rate of 5.5% per year.7

Chronicity of the arrhythmia is associated with progressive atrial remodeling. The 2016 study by Hussein et al. demonstrated that the shorter the time interval between the first diagnosis of persistent AF and the catheter ablation, the better the outcomes. Longer diagnosis to ablation time was associated with markers of atrial remodeling.8



Miyasaka Y et al. Mortality trends in patients diagnosed with first atrial fibrillation: a 21-year community based study. J Am Coll Cardiol. 2007; 49(9): 986-92.


Wolf P et al. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke. 1991; 22(8):983-88.


Lubitz SA et al. Atrial fibrillation patterns and risks of subsequent stroke, heart failure, or death in the community. J AM Heart Assoc. 2013; 2(5):e000126


Chen LY et al. Atrial fibrillation and its association with sudden cardiac death. Circ J. 2014; 78(11):2588-93.


Dorian P et al. The impairment of health-related quality of life in patients with intermittent atrial fibrillation: implications for the assessment of investigational therapy. J Am Coll Cardiol. 2000; Oct; 36(4):1303-9.


Kuck KH, Brugada J, Fürnkranz A, et al. The FIRE and ICE Trial: looking beyond the primary efficacy and safety endpoints. Late-breaking clinical trial. Presented at Cardiostim 2016


Kato T, et al. Circ J (2004) 68: 568


Hussein et al. Circ Arrhythm Electrophysiol. 2016 Jan;9(1):e003669

See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. For further information, contact your local Medtronic representative and/or consult the Medtronic website at

CARTO® system products are CE marked by Biosense Webster.