In vivo safety and pulmonary vein isolation performance of a new cryoballoon for the treatment of atrial fibrillation
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JICE-D-24-00127_R2-For UA ...
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2025-06-03
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Final Accepted Manuscript
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College of Medicine, University of Arizona,Issue Date
2024-06-03
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Bai, R., Liao, Y., Wang, X., Rosenthal, K., Vessey, J., Mazor, M., & Su, W. (2024). In vivo safety and pulmonary vein isolation performance of a new cryoballoon for the treatment of atrial fibrillation. Journal of Interventional Cardiac Electrophysiology, 1-10.Rights
© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.Collection Information
This item from the UA Faculty Publications collection is made available by the University of Arizona with support from the University of Arizona Libraries. If you have questions, please contact us at repository@u.library.arizona.edu.Abstract
Background: Cryoablation to achieve pulmonary vein (PV) isolation has become one of the standard approaches for atrial fibrillation (AF) ablation. The Arctic Front series cryoballoon and Achieve circular mapping catheter (Medtronic) inherently possess design defects that have been associated with unfavorite clinical outcomes. Lately, a new cryoablation system (Nordica Cryoablation System, Synaptic Medical) was developed with improved design of the cryoballoon and circular mapping catheter to address the inadequacies of current cryoablation technology. An animal study was conducted to test the efficacy and safety in performing PVI with the Nordica Cryoablation System. Methods: Pulmonary vein isolation with the Nordica Cryoablation System was performed on 12 PVs of six healthy canines. Acute PVI and peri-procedural complications were recorded. All animals underwent a repeat EP study at least 4 weeks after index procedures followed by pathological and histological assessments of the heart and collateral/downstream organs after planned euthanasia. Results: Acute PV isolation was achieved in all targeted PVs with 50% of PVs being isolated with a single cryoablation application. There were no major peri-procedural complications or device malfunction events. All PVs remained isolated after 29–30 days follow-up. Histological examination showed transmural cryo-lesions at treated sites with minimal inflammation, neovascularization, and neointima formation but no significant injury to adjacent tissue or embolization in downstream organs. Conclusion: Acute and durable PVI can be achieved by using the novel Nordica Cryoablation System. Ablation with this new cryoablation system is associated with transmural lesions at targeted myocardium but creates no injury to the collateral tissues or downstream organs.Note
12 month embargo; published 03 June 2024EISSN
1572-8595PubMed ID
38831168Version
Final accepted manuscriptae974a485f413a2113503eed53cd6c53
10.1007/s10840-024-01836-5
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