Author + information
- Received May 21, 2018
- Revision received July 5, 2018
- Accepted July 19, 2018
- Published online November 19, 2018.
- Serge Boveda, MDa,∗ (, )
- Andreas Metzner, MDb,
- Dinh Q. Nguyen, MDc,
- K.R. Julian Chun, MDd,
- Konrad Goehl, MDe,
- Georg Noelker, MDf,
- Jean-Claude Deharo, MDg,
- George Andrikopoulos, MDh,
- Tillman Dahme, MDi,
- Nicolas Lellouche, MDj and
- Pascal Defaye, MDk
- aClinique Pasteur, Toulouse, France
- bAsklepios Klinik St. Georg, Hamburg, Germany
- cSt. Vinzenz-Hospital, Köln, Germany
- dMarkuskrankenhaus, Cardioangiologisches Centrum Bethanien, Frankfurt, Germany
- eKlinikum Nürnberg Süd, Nürnberg, Germany
- fClinic for Cardiology Herz- und Diabeteszentrum North Rhine-Westphalia Ruhr-Universität Bochum, Bad Oeynhausen, Germany
- gCentre Hospitalier Universitaire de la Timone, Marseille, France
- hHenry Dunant Hospital Center, Athens, Greece
- iUniversitätsklinikum Ulm, Ulm, Germany
- jCentre Hospitalier Universitaire Henri Mondor, Créteil, France
- kCentre Hospitalier Universitaire de Grenoble-Alpes, Grenoble, France
- ↵∗Address for correspondence:
Dr. Serge Boveda, Clinique Pasteur, 45, avenue du Lombez, BP 27617, 31076 Toulouse Cedex 3, France.
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)
This study was funded by Medtronic International Trading. Dr. Boveda has received consultant fees from Medtronic, Boston Scientific, and LivaNova. Dr. Metzner has received speaker honoraria and travel grants from Medtronic. Dr. Nguyen has served as a proctor for Abbott and Medtronic. Dr. Chun has received consultant fees from Medtronic and CardioFocus. Dr. Noelker has received lecture fees from Medtronic. Dr. Andrikopoulos has received research grant support from, received lecture fees from, and served on the advisory board for Medtronic, St. Jude Medical, and Boston Scientific. Dr. Dahme has received speaker honoraria and consulting fees from Medtronic. Dr. Lellouche has received consulting fees from Medtronic, Abbott, and Boston Scientific. Dr. Defaye has received research grant support from Medtronic, Boston Scientific, and Abbott/St. Jude Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
All authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Clinical Electrophysiology author instructions page.
- Received May 21, 2018.
- Revision received July 5, 2018.
- Accepted July 19, 2018.
- 2018 The Authors