One-year follow-up after single procedure Cryoballoon ablation: a comparison between the first and second generation balloon

Abstract

Background: With respect to the first generation Cryoballoon (CB), the second generation (Cryoballoon Advance [CB-A], Medtronic, Minneapolis, MN, USA) was designed with technical modifications resulting in a larger and more uniform zone of freezing on the balloon's surface aiming at procedural outcome improvement in the setting of atrial fibrillation (AF) ablation. However, a comparison between both technologies on a midterm follow-up is missing in today's literature.

Methods: A total of 100 patients (the last 50 patients with the first generation CB and the first 50 patients with the second generation CB-A upon its inception in our center) having undergone a single CB ablation for paroxysmal AF (PAF) and having completed a 12-month follow-up, were consecutively included in our study. Freedom from AF off-antiarrhythmic drugs (AADs) after a single procedure was 78% (39/50) in CB-A and 58% (29/50) in the CB group (P = 0.03) during the whole follow-up duration. Considering a blanking period of 3 months, freedom from AF off-AAD was achieved in 84% (42/50) in CB-A, while 66% (33/50) were free from recurrence in the CB group (P = 0.038). Right phrenic nerve palsy (PNP) occurred in 8 patients (16%) in CB-A group and in 4 patients (8%) in the CB group.

Conclusion: Freedom from AF on 12 months follow-up was significantly higher in the CB-A group with respect to the first generation device. The most frequent complication observed was PNP.

Keywords: atrial fibrillation; catheter ablation; cryoballoon; phrenic nerve; pulmonary vein isolation.