Arctic Front Advance

Below is a summary of publications on Arctic Front Advance. STOP AF, referenced on the first tab in this section, is the pivotal study supporting the approval of Arctic Front and Arctic Front Advance.

1-Year Efficacy Rates ≥ 80% Observed in Single-Center Studies^1-4

*study details shown below

1-year Comparison of Outcomes Between 1st Generation and 2nd Generation Cryoballoons: Di Giovanni, et al.⁵

• 100 patients with AF: 50 treated with the 1st generation cryoballoon (CB) and 50 treated with the 2nd generation cryoballoon (CB-A)
• Freedom from AF at 12 months significantly higher in the CB-A arm (84%) than the CB arm (66%) (p=0.038).
• PNP occurred in 12.9% of patients (16% CB-A vs 8% CB).* 3 of the 8 PNP's in the CB-A group persisted beyond discharge (1 until 10 months follow-up). None of the 4 PNP's in the CB group persisted beyond discharge.

*Authors noted "Importantly, nearly all PNPs occurred in the first 20 patients when occlusion was obtained by vigorous wedging of the CB-A in the PV ostium. In the most recent patients this complication was dramatically reduced by achieving a more proximal seal in the right-sided veins".

1-year Clinical Outcome with Arctic Front Advance: Metzner, et al.⁶

• 50 patients with AF treated with 28mm Arctic Front Advance Cryoballoon
• Freedom from AF at 1-year was 80% (mean 440 days follow-up; 3 mo. blanking period)
• PNP occurred in 1/50 (2%) patients (persistent, resolved 10 months post-ablation)

Freedom from AF after 1 Year with 2nd Generation vs. 1st Generation Cryoballoons: Fürnkranz, et al.⁷

• 105 patients with PAF: 50 treated with Arctic Front (CB1); 55 with Arctic Front Advance (CB2).
• Freedom from AF after 1 year was 63.9% vs. 83.6% (p = 0.008) in the CB1 and CB2 groups, respectively (mean follow-up of 416 ± 75 days).
• PNP with delayed healing occurred in 4.0% (2/50) of patients in CB1 group and 5.55% (3/55) in the CB2 group. 2 additional patients in the CB1 group and 4 in the CB2 group had transient PNP that resolved upon immediate cessation of the freeze.

Freedom from AF after 1 Year with 2nd Generation vs. 1st Generation Cryoballoons: Chierchia, et al.⁸

• 42 patients with PAF treated with Arctic Front Advance
• Freedom from AF at 12 months follow-up in 83% of patients following a 3-month blanking period
• Phrenic nerve palsy occurred in 19% of patients (8), five of which recovered prior to discharge and the remaining three during follow-up

Sustained Safety and Improved Procedural Efficacy of Arctic Front Advance vs. Arctic Front: Straube, et al.⁹

Study Design

• Non-randomized, prospective, observational study
• 484 consecutive AF patients underwent cryoablation with Arctic Front (CBG1) or Arctic Front Advance (CBG2)
• 5-min freeze–thaw cycles were used with CBG1 vs. 4-mins with CBG2

Results

• Comparable low rates of PNP and major adverse events were recorded
• Mean total procedure time, LA Dwell time, and fluoroscopy time significantly decreased with the CBG2 by 5%, 10%, and 14%, respectively.
• Mean applications until PVI significantly decreased from 1.45 to 1.28 with CBG2 (p=0.001).