DOI: 10.2459/jcm.0000000000001886 ISSN: 1558-2027

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

Emanuele Bertaglia, Giuseppe Arena, Claudio Tondo, Giulio Molon, Paolo Pieragnoli, Gianfranco Mitacchione, Massimiliano Manfrin, Giovanni Perego, Roberto Rordorf, Danilo Ricciardi, Enrico Chieffo, Massimiliano Marini, Umberto Startari, Giuseppe Boriani, Pietro Turrini, Saverio Iacopino

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.

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