Novel cryoballoon technology for atrial fibrillation ablation: Impact of pulmonary vein variant anatomy, cooling characteristics, and 1-year outcome from the CHARISMA registry

Background: No data have been reported on cooling characteristics and the impact of variant pulmonary vein (PV) anatomy on atrial fibrillation (AF) recurrences after POLARx cryoballoon (CB) ablation. Objective: The purpose of this study was to analyze the impact of PV anatomy variants and cooling characteristics after CB ablation from a large multicenter prospective registry. Methods: The primary end point was defined as 1-year absence of any atrial tachyarrhythmias (ATAs: AF/atrial flutter/atrial tachycardia). Correlation between ATA recurrences and anatomy variants/cooling characteristics were evaluated. The secondary outcome was the rate of major periprocedural complications. Results: A total of 429 consecutive patients diagnosed with paroxysmal AF (83.4%) or persistent AF (peAF; 16.6%) were enrolled. Twenty-eight patients (6.6%) exhibited an anatomical variant (common ostium: 4.0%; adjunctive PV: 2.6%). Nadir temperature, thaw time, and total deflation time were different between standard PVs and PV variants. After the blanking period, over a mean of 431 ± 99 days of follow-up, 63 patients (14.7%) suffered an ATA recurrence. Patients with recurrences had both a shorter thaw time (18.5 ± 7 seconds vs 19.8 ± 7 seconds; P = .0012) and a shorter total deflation time, whereas time to isolation was longer (57.4 ± 42 seconds vs 49.1 ± 33 seconds; P = .04). Patients with anatomy variants showed a similar ATA recurrence rate (5 of 28 [17.9%]) to the standard PV anatomy group (58 of 401 [14.5%]) (P = .584), with a hazard ratio (HR) of 1.43 (95% confidence interval [CI] 0.49–4.13; log-rank, P = .4384). After adjusting for confounders, heart failure (HR 4.12; 95% CI 1.75–9.73; P = .0013) and peAF (HR 1.81; 95% CI 1.03–3.18; P = .0433) remained associated with ATA recurrence during follow-up. Conclusion: The POLARx CB system demonstrated long-term efficacy, along with a safe profile, in both patients with paroxysmal AF and those with peAF, regardless of the presence PV variants. Time to isolation was longer in patients with ATA recurrences during follow-up. Clinical Trial Registration: Catheter Ablation of Arrhythmias with a High-Density Mapping System in Real-World Practice (CHARISMA). ClinicalTrials.gov identifier: NCT03793998. Registration date: January 4, 2019.