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Ablation of atrial fibrillation with cryoballoon or duty-cycled radiofrequency pulmonary vein ablation catheter: a randomized controlled study comparing the clinical outcome and safety; the AF-COR study
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
2013 (English)In: Europace, ISSN 1099-5129, E-ISSN 1532-2092, Vol. 15, no 11, 1567-1573 p.Article in journal (Refereed) Published
Abstract [en]

AIMS:

The urge to facilitate the atrial fibrillation (AF) ablation procedure has led to the development of new ablation catheters specifically designed as 'one-shot tools' for pulmonary vein isolation (PVI). The purpose of this study was to compare the efficacy, safety, and procedure times for two such catheters using different energy sources.

METHODS AND RESULTS:

One hundred and ten patients, referred for ablation of paroxysmal or persistent AF, were randomized to treatment with either the cryoballoon or the circular multipolar duty-cycled radiofrequency-based pulmonary vein ablation catheter (PVAC). Complete PVI was achieved in 98 vs. 93% patients in the cryoballoon and PVAC group, respectively, with complication rates of 8 vs. 2% (P = 0.2). Complete freedom from AF, without antiarrhythmic drugs, after one single ablation procedure was seen in 46% in the cryoballoon vs. 34% after 12 months (P = 0.2). Procedure times were comparable, but fluoroscopy time was shorter for the cryoballoon (32 ± 16 min) than for the PVAC procedures (47 ± 17 min) (P < 0.001). A significant improvement of quality of life (QoL) and arrhythmia-related symptoms was seen in both groups after ablation.

CONCLUSION:

Both catheters proved comparably effective and safe in achieving acute PVI, apart from the shorter fluoroscopy times achieved with the cryoballoon. At follow-up, there was no statistically significant difference between the groups regarding freedom from AF and clinical success. The QoL increased to the same levels as for the general Swedish population in both groups.

Place, publisher, year, edition, pages
2013. Vol. 15, no 11, 1567-1573 p.
National Category
Medical and Health Sciences
Research subject
Cardiology
Identifiers
URN: urn:nbn:se:uu:diva-201282DOI: 10.1093/europace/eut104ISI: 000326674600006PubMedID: 23703361OAI: oai:DiVA.org:uu-201282DiVA: diva2:626592
Available from: 2013-06-10 Created: 2013-06-10 Last updated: 2017-12-06Bibliographically approved
In thesis
1. Catheter Ablation of Atrial Fibrillation and Atrial Flutter: A Comparison of Cryo and Radiofrequency Techniques
Open this publication in new window or tab >>Catheter Ablation of Atrial Fibrillation and Atrial Flutter: A Comparison of Cryo and Radiofrequency Techniques
2014 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

Atrial fibrillation (AF) and atrial flutter (AFl) are two of the most common arrhythmias encountered in the population. Catheter ablation has emerged as a useful tool in the treatment of these arrhythmias. Although radiofrequency (RF) is the most commonly used energy source for ablation, cryoenergy may have some advantageous properties. The purpose of these studies was to evaluate and compare ablation with novel ablation catheters using either of these energy sources.

When used for AFl ablation, cryoenergy was associated with less perceived pain than radiofrequency. However, the acute success rate was significantly lower for cryoablation (56%) compared with RF ablation (100%) in our study.

Being one of the first centres to use a new so-called “one-shot” device for pulmonary vein isolation (PVI), the cryoballoon, we described our initial experience with this catheter in 40 patients undergoing AF ablation.  A high rate of PVI could be achieved although an additional cryocatheter was needed in 44% of the procedures. Freedom from arrhythmia-related symptoms was seen in 53% after a mean follow-up of 8.9 months.

Comparing the cryoballoon and a RF-based device intended for PVI, the pulmonary vein ablation catheter (PVAC), both catheters proved comparably effective (≥93%) and safe in achieving PVI with comparable procedure times. After 12 months only 46% versus 34% (ns) in the cryoballoon- and the PVAC group, respectively, were regarded as free from AF without antiarrhythmic drugs, after one ablation procedure, whereas 60% versus 54% reported clinical success. Quality of life was significantly increased in both groups, to a level comparable with the general Swedish population.

We tested the hypothesis that RF ablation would be accompanied by a higher activation of the coagulation and inflammatory systems, measured by biomarkers. Such a difference could not be supported in our study, which showed a comparable response with either technique, even though the cryoballoon caused more pronounced myocardial damage.

Two different energy settings with different ratios of bipolar-to-unipolar energy were tested with the PVAC under the hypothesis that ablation with a higher proportion of unipolar energy would require fewer applications in order to achieve PVI. However, this study failed to show any difference between the groups.

Place, publisher, year, edition, pages
Uppsala: Acta Universitatis Upsaliensis, 2014. 90 p.
Series
Digital Comprehensive Summaries of Uppsala Dissertations from the Faculty of Medicine, ISSN 1651-6206 ; 959
National Category
Medical and Health Sciences
Identifiers
urn:nbn:se:uu:diva-212806 (URN)978-91-554-8830-7 (ISBN)
Public defence
2014-02-14, Enghoff salen, Ing 50, Akademiska sjukhuset, Uppsala, 09:15 (English)
Opponent
Supervisors
Available from: 2014-01-23 Created: 2013-12-14 Last updated: 2014-02-10

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Malmborg, HelenaLönnerholm, StefanBlomström, PerBlomström-Lundqvist, Carina

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