Progressive reduction in complications of cryoballoon pulmonary vein isolation for atrial fibrillation

Aims: Cryoballoon pulmonary vein isolation (CB-PVI) has become an established treatment for atrial fibrillation and, recently, it has been proposed as first-line therapy for the treatment of paroxysmal atrial fibrillation. Nevertheless, some concerns remain regarding the safety of this thermal energy-based approach. This prospective analysis aimed to assess the procedural complication rate of CB-PVI in a large cohort of consecutive patients over a nearly 13-year period. Methods: Data from consecutive patients treated with CB-PVI for atrial fibrillation between April 2012 and November 2024 in 35 institutions were analyzed. All complications occurring from patient admission up to 3 months postprocedure were recorded. Results: Eight thousand five hundred and thirty-one patients were enrolled (27.2% women, mean age 60.8 ± 10.5 years, 75.7% with paroxysmal atrial fibrillation), and 211 of them (2.49%) experienced at least one procedural adverse event related to CB-PVI. Of note, one cardiac tamponade event led to a sudden cardiovascular death (0.01%). A statistically significant reduction in complication rates was observed amongst three cohorts of product usage: from 2012 to 2015 ( n  = 1326 patients, 5.0%), from 2016 to 2019 ( n  = 3487 patients, 2.5%), and from 2020 to 2024 ( n  = 3718 patients, 1.6%; P  < 0.001). Multivariate logistic regression analysis identified use of the Arctic Front Advance PRO balloon as a significant protective factor against complications [OR 0.26 (0.17-0.40), P  < 0.001], whereas female sex emerged as the strongest predictor of adverse events [OR 1.54 (1.11-2.13), P  < 0.01]. Conclusion: CB-PVI for atrial fibrillation ablation has proven to be a well tolerated procedure, with a steadily decreasing complication rate over time.