Comparison of Outcomes Using the First and Second Generation Cryoballoon to Treat Atrial Fibrillation.

BACKGROUND

Pulmonary vein isolation using cryoballoon ablation is an effective treatment for patients with atrial fibrillation. We sought to compare outcomes with the first and second generation cryoballoon, with the second generation balloon incorporating the Achieve Lasso catheter, in terms of freedom from symptomatic recurrence and major complications.

METHODS

The first 200 patients who underwent cryoballoon ablation with the first generation balloon were compared with the first 200 patients using the second-generation balloon. All patients had symptomatic atrial fibrillation and had failed at least one antiarrhythmic drug. The primary efficacy endpoint was freedom from symptomatic recurrence of atrial fibrillation (AF) after a single pulmonary vein isolation (PVI) procedure using the cryoballoon. The primary safety endpoint was major procedural complications.

RESULTS

At 12 months, freedom from symptomatic AF after a single procedure in the first generation cohort was 64.3% compared with 78.6% in the second-generation cohort (p = 0.002). At 24 months, freedom from symptomatic AF in the first generation cohort was 51.3% compared with 72.6% in the second-generation cohort (p < 0.001). Procedural time (150 min vs 101 min; p < 0.001) and fluoroscopy time (32.5 min vs 21.4 min; p < 0.001) was lower in the second-generation group. The rate of major complications was comparably low in both groups.

CONCLUSIONS

The second-generation cryoballoon was associated with improved freedom from symptomatic AF with reduction in procedure and fluoroscopy time, with a similar low rate of major complications.