Cryoballoon ablation of atrial fibrillation is effectively feasible without previous imaging of pulmonary vein anatomy: insights from the 1STOP project
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Pulmonary vein isolation by cryoablation (PVI-C) is a standard therapy for the treatment of atrial fibrillation (AF); however, PVI-C can become a challenging procedure due to the anatomy of the left atrium and pulmonary veins (PVs). Importantly, the utility of imaging before the procedure is still unknown regarding the long-term clinical outcomes following PVI-C. The aim of the analysis is to evaluate the impact of imaging before PVI-C on procedural data and AF recurrence.
Patients with paroxysmal AF underwent an index PVI-C. Data were collected prospectively in the framework of 1STOP ClinicalService® project. Patients were divided into two groups according to the utilization of pre-procedural imaging of PV anatomy (via CT or MRI) or the non-usage of pre-procedural imaging.
Out of 912 patients, 461 (50.5%) were evaluated with CT or MRI before the PVI-C and denoted as the imaging group. Accordingly, 451 (49.5%) patients had no pre-procedural imaging and were categorized as the no imaging group. Patient baseline characteristics were comparable between the two cohorts, but the ablation centers that comprised the imaging group had fewer PVI-C cases per year than the no imaging group (p < 0.001). The procedure, fluoroscopy, and left atrial dwell times were significantly shorter in the no imaging cohort (p < 0.001). The rates of complications were significantly greater in the imaging group compared to the no imaging group (6.9% vs. 2.7%; p = 0.003); this difference was attributed to differences in transient diaphragmatic paralysis. The 12-month freedom from AF was 76.2% in the imaging group and 80.0% in the no imaging group (p = 0.390).
In our analysis, PVI-C was effective regardless of the availability of imaging data on PV anatomy.
KeywordsParoxysmal atrial fibrillation Cryoballoon Outcomes AF recurrences Cardio imaging
Body mass index
Chronic kidney disease
European Heart Rhythm Association
Left ventricular ejection fraction
Paroxysmal atrial fibrillation
Pulmonary vein isolation by cryoablation
Transient ischemic attack
This research was performed within the framework of the Italian ClinicalService, a project funded by Medtronic Italy, an affiliate of Medtronic Inc. No other funding sources were involved in the research.
Compliance with ethical standards
All procedures performed in this project involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
Conflict of interest disclosures
Maurizio Lunati and Roberto Verlato received modest consultancy and speaker’s fees from Medtronic. Maurizio Landolina received modest consultancy and speaker’s fees from Medtronic, Boston Scientific, and Boehringer Ingelheim. Giulio Molon received modest consultancy fees from Medtronic and Boston Scientific and speaker’s fees from Medtronic, Boston Scientific, St. Jude, and Boehringer Ingelheim. Claudio Tondo serves as a member of Medtronic European Advisory Board and Boston Scientific International Advisory Board. He received lecture and proctor fees from Medtronic, Abbott Medical, Biosense Webster, and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
This project was approved by each site’s Institutional Review Board and Local Ethics Committees.
Each patient included in the ClinicalService project provided informed consent for data collection and analysis.
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