Novel second-generation cryoballoon: improved procedural efficacy of pulmonary vein isolation

Introduction: Short-term efficacy following novel Arctic Front Advance™ cryoballoon (CBA) ablation of atrial fibrillation (AF) remains unknown due to its recent introduction in May 2012. This study describes the first experience of CBA compared to ArcticFront™ cryoballoon (CB) in patients with paroxysmal atrial fibrillation (PAF) regarding the impact of the novel design on procedural and clinical efficacy. Methods: In total, 90 patients were enrolled with symptomatic drug refractory PAF. Data were analyzed and compared using matched pair analysis: 45 pts in the CB- and CBA group each. Pulmonary vein isolation (PVI) was performed using cryoballoon catheters in conjunction with Achieve™ intraluminal mapping catheters. PVI was defined as complete elimination of all fragmented signals at PV antrum/ostium with verification of entrance- and exit block. Primary endpoint of this consecutive single-center study was first electrocardiogram-documented recurrence of AF, atrial tachycardia or atrial flutter longer than 30 seconds. In all patients every 3 months clinical follow-up including 7 day holter ECG was performed. Results: In the CB-group 29 patients were male (64%), median age 56 y (IQR's Q25/Q75=50/64), LVEF 61 (57/62) %, normalized left atrium (NLA) 9.56 (8.72/10.71), hypertension in 23 pts (51%). In CBA-group 31 patients were male (69%), median age 59 y (49/62), LVEF 62 (57/63) %, NLA 9.18 (8.60/10.32), hypertension in 27 pts (60%). Median procedure time lasted 2.9 (2.5/3.8) hours and fluoroscopy time 31 (25/47) minutes in patients treated with CB vs. 2.2 (2.0/2.5) hours and fluoroscopy time 23 (18/29) minutes in patients treated with CBA (p<.001 for both). Acute and complete PVI was achieved in all patients. Regarding the primary endpoint the short-term success rate after single CBA ablation was 89% and in CB 73% (p=.112). Conclusions: In this first experience with the novel CBA sinus rhythm can be maintained in a substantial proportion of patients after circumferential PVI using CB technology with an evident trend towards improved efficacy when using novel generation CBA with significant procedural improvements. Further evaluation with higher patient numbers is needed for long term course evaluation.