Objectives: The purpose of this study was to investigate possible differences in procedural parameters and clinical follow-up between the new Arctic Front Advance© Cryoballoon (Medtronic) and the already established Artic Front© Cryoballoon (Medtronic) used for pulmonary vein isolation (PVI) in a paroxysmal atrial fibrillation (PAF) population.
Methods: Between 2010 and 03/2013, we performed PVI with cryoballoons in 186 patients with PAF (143 with the Arctic Front© and 43 with the new Arctic Front Advance© Cryoballoon, respectively).
Both devices were used according to the recommendations of the manufacturer with a freeze time of 300 sec for the Artic Front© and 240 sec for the Artic Front Advance©, respectively and a minimum of 2 freezes for each PV.
In order to eliminate data from the learning curve with a single-shot balloon-catheter, we excluded the first 30 patients ablated with the Arctic Front© from retrospective analysis. In consequence, we compared procedure- and fluoroscopy times, the need for touch-up ablations as well as the incidence of phrenic nerve palsy between 113 Artic Front© - and 43 Artic Front Advance©-patients.
Clinical follow-up consisted of 48-hour ECG monitoring at 3, 6, and 12 months after ablation plus additional ECGs recorded during episodes of suspicious symptoms. Freedom from atrial arrhythmias ? 30 seconds was counted as clinical success.
Results: Significant reduction of procedure time (mean 163 ± 49min for the Arctic Front© vs. mean 110 ± 30 min for the Arctic Front Advance©, p<0.001) and fluoroscopy exposure (mean 36 ± 16 min for the Arctic Front© vs. 21 ± 5 min for the Arctic Front Advance©, p<0.001) could be observed. The need for touch-up ablations was 7/113 (6%) and 2/43 (5%) for the Artic Front© and the Artic Front Advance©, respectively (p=ns). Phrenic nerve palsy occurred in 4/113 (4%) of the Arctic Front©-patients and in no Arctic Front Advance©-patient (p=ns).
Clinical 3-month efficacy was similar in both groups with freedom from AF: 84/113 patients (74%) in the Arctic Front©-group and 33/43 (77%) patients in the Arctic Front Advance© group, respectively (p=ns).
Conclusions: Compared to the Artic Front© cryoballoon, the new Arctic Front Advance© cryoballoon could significantly reduce the procedure and fluoroscopy times of PVI without a reduction of the safety or efficacy of the intervention. Thus, the positive evolution of this catheter could be a key for increasing the number of treated patients by making the intervention easier and faster.