Serge Boveda, Andreas Metzner, Dinh Q. Nguyen, Kyoung-Ryul Julian Chun, Konrad Göhl, Georg Nölker, Jean-Claude Deharo, George Andrikopoulos, Tillman Dahme, Nicolas Lellouche, Pascal Defaye
- Objectives: The CRYO4PERSISTENT AF (Cryoballoon Ablation for Early Persistent Atrial Fibrillation) trial aims to report long-term outcomes after a single pulmonary vein isolation (PVI)–only ablation procedure using the second-generation cryoballoon in persistent atrial fibrillation (PerAF) patients.
Background: Pulmonary vein isolation is recognized as the cornerstone of atrial fibrillation (AF) ablation, including ablation of PerAF.
Methods: The CRYO4PERSISTENT AF trial (NCT02213731) is a prospective, multicenter, single-arm trial designed to assess single-procedure outcomes of PVI using the cryoballoon. The primary endpoint was freedom from AF, atrial flutter, or atrial tachycardia ≥30 s after a 90-day blanking period. After enrollment, but before ablation, patients without 100% AF burden (18-h Holter monitoring or 3 consecutive electrocardiograms in a time frame ≥14 days) were excluded. Patients were followed at 3, 6, and 12 months, with 48-h Holter monitoring at 6 and 12 months. Quality of life and symptoms were evaluated at baseline and 12 months. Arrhythmia recurrence and adverse events were adjudicated by an independent committee.
Results: A total of 101 patients (62 ± 11 years of age, 74% men, left ventricular ejection fraction 56 ± 8%, left atrial diameter 43 ± 5 mm) meeting criteria, undergoing cryoballoon-based PVI, with follow-up data, were included. Kaplan-Meier estimate of freedom from AF, atrial flutter, or atrial tachycardia recurrence was 60.7% at 12 months. Compared with baseline, there were significantly fewer patients with arrhythmia-related symptoms at 12 months (16% vs. 92%; p < 0.0001). The symptom reduction was supported by significant improvement in 36-Item Short Form Health Survey composite scores and European Heart Rhythm Association score at 12 months. The only device related event was transient phrenic nerve injury in 2 (2%) patients, with resolution pre-discharge.
Conclusions: Cryoballoon ablation for treatment of PerAF demonstrated 61% single-procedure success at 12 months post-ablation in addition to significant reduction in arrhythmia-related symptoms and improved quality of life. (Cryoballoon Ablation for Early Persistent Atrial Fibrillation [Cryo4 Persistent AF]; NCT02213731)
MetadatenAuthor: | Serge Boveda, Andreas Metzner, Dinh Q. Nguyen, Kyoung-Ryul Julian ChunORCiDGND, Konrad Göhl, Georg Nölker, Jean-Claude Deharo, George Andrikopoulos, Tillman Dahme, Nicolas Lellouche, Pascal Defaye |
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URN: | urn:nbn:de:hebis:30:3-484732 |
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DOI: | https://doi.org/10.1016/j.jacep.2018.07.007 |
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ISSN: | 2405-500X |
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ISSN: | 2405-5018 |
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Pubmed Id: | https://pubmed.ncbi.nlm.nih.gov/30466850 |
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Parent Title (English): | JACC Clinical electrophysiology |
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Publisher: | Elsevier |
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Place of publication: | Amsterdam |
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Document Type: | Article |
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Language: | English |
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Year of Completion: | 2018 |
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Date of first Publication: | 2018/08/25 |
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Publishing Institution: | Universitätsbibliothek Johann Christian Senckenberg |
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Release Date: | 2018/12/13 |
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Tag: | catheter ablation; cryoballoon; persistent atrial fibrillation; pulmonary vein isolation |
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Volume: | 4 |
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Issue: | 11 |
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Page Number: | 8 |
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First Page: | 1440 |
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Last Page: | 1447 |
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Note: | © 2018 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). |
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HeBIS-PPN: | 446487708 |
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Institutes: | Medizin / Medizin |
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Dewey Decimal Classification: | 6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit |
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Sammlungen: | Universitätspublikationen |
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Licence (German): | Creative Commons - Namensnennung-Nicht kommerziell - Keine Bearbeitung 4.0 |
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