Progressive reduction in complications of cryoballoon pulmonary vein isolation for atrial fibrillation.
E, B., G, A., C, T., G, M., P, P., G, M., M, M., G, P., R, R., & D, R. (2026). Progressive reduction in complications of cryoballoon pulmonary vein isolation for atrial fibrillation.. Journal of cardiovascular medicine (Hagerstown, Md.). https://doi.org/10.2459/JCM.0000000000001886
E B, G A, C T, G M, P P, G M, et al. Progressive reduction in complications of cryoballoon pulmonary vein isolation for atrial fibrillation.. Journal of cardiovascular medicine (Hagerstown, Md.). 2026; doi: 10.2459/JCM.0000000000001886
E B, G A, C T, et al. Progressive reduction in complications of cryoballoon pulmonary vein isolation for atrial fibrillation.[J]. Journal of cardiovascular medicine (Hagerstown, Md.). 2026. DOI: 10.2459/JCM.0000000000001886.
@article{e2026,
author = {Bertaglia E and Arena G and Tondo C and Molon G and Pieragnoli P and Mitacchione G and Manfrin M and Perego G and Rordorf R and Ricciardi D},
title = {Progressive reduction in complications of cryoballoon pulmonary vein isolation for atrial fibrillation.},
journal = {Journal of cardiovascular medicine (Hagerstown, Md.)},
year = {2026},
doi = {10.2459/JCM.0000000000001886},
note = {PMID: 42349391},
}
TY - JOUR AU - Bertaglia E AU - Arena G AU - Tondo C AU - Molon G AU - Pieragnoli P AU - Mitacchione G AU - Manfrin M AU - Perego G AU - Rordorf R AU - Ricciardi D TI - Progressive reduction in complications of cryoballoon pulmonary vein isolation for atrial fibrillation. T2 - Journal of cardiovascular medicine (Hagerstown, Md.) PY - 2026 DO - 10.2459/JCM.0000000000001886 AN - PMID:42349391 ER -
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.