Key result
Third-generation cryoballoon ablation significantly reduced procedure time (91.4 vs 110.9 min, p=0.018) with similar 1-year AF-free survival compared to second-generation cryoballoon (p=0.49).
Why the study?
Does third-generation cryoballoon improve procedural metrics and maintain efficacy compared to second-generation cryoballoon in patients with atrial fibrillation?
Observational (n=68)
Does third-generation cryoballoon improve procedural metrics and maintain efficacy compared to second-generation cryoballoon in patients with atrial fibrillation?
The third-generation cryoballoon simplifies AF ablation by improving real-time signal recording and reducing procedure time, while maintaining comparable 1-year clinical efficacy to the second-generation device.
Third-generation cryoballoon may shorten AF ablation time with similar 1-year efficacy; leaves open confirmation in randomized trials.
BACKGROUND: Third-generation cryoballoon (CB3) is characterized by a 40% shorter distal tip designed to increase the rate of pulmonary veins real-time signal recording in order to measure time necessary to isolate veins, the "Time to effect" (TTE). Few data are currently available on clinical follow up of CB3 treated patients. METHODS: Sixtyeight consecutive patients (mean age 57.8 ± 9.6 years, 48 male) with paroxysmal or persistent atrial fibrillation (AF) were enrolled. Thirthyfour (25 paroxysmal AF) underwent to a 28 mmCB3 pulmonary veins isolation and were compared to 34 treated (21 paroxysmal AF) with 28 mmCB2. RESULTS: CB3 use was correlated to significant increase of the possibility to measure TTE in every treated veins (left superior 82,35% vs 23,53%, left inferior 70,59% vs 38,24%, right superior 58,82% vs 14,71%, right inferior 52,94% vs 17,65%). When it is measured, TTE wasn't different between two groups. Higher nadir temperature was observed in CB3 patients (-39.4 ± 5.2 °C vs -43.0 ± 7.2 °C, p = 0.03). CB3 procedures were shorter (91.4 ± 21.7 vs 110.9 ± 31.8 min, p = 0.018), with a significant reduction in cryoenergy delivery time (24.2 ± 8.5 vs 20.3 ± 6.7 min, p < 0.05), and a significant reduction in left atrium dwell time (59.3 ± 9.8 vs 69.3 ± 10.8 min, p = 0.02, p < 0.05). At one year follow up period the Kaplan-Meier curve didn't show any significant difference in AF-free survival (Log p = 0,49). CONCLUSIONS: Novel CB3 is a useful tool in order to simplify AF cryoballoon ablation when compared to second generation cryoballoon, as observed in our experience. Follow up data seem confirm a clinical CB3 efficacy at least comparable CB2.
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Sciarra et al. (2018) conducted an observational in Paroxysmal or persistent atrial fibrillation (n=68). Third-generation cryoballoon (CB3) vs. Second-generation cryoballoon (28 mm CB2) was evaluated on AF-free survival at one year (p=0.49). Third-generation cryoballoon ablation significantly reduced procedure time (91.4 vs 110.9 min, p=0.018) with similar 1-year AF-free survival compared to second-generation cryoballoon (p=0.49).
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