TY  - JOUR
A1  - Boveda, Serge
A1  - Metzner, Andreas
A1  - Nguyen, Dinh Q.
A1  - Chun, Kyoung-Ryul Julian
A1  - Göhl, Konrad
A1  - Nölker, Georg
A1  - Deharo, Jean-Claude
A1  - Andrikopoulos, George
A1  - Dahme, Tillman
A1  - Lellouche, Nicolas
A1  - Defaye, Pascal
T1  - Single-procedure outcomes and quality-of-life improvement 12 months post-cryoballoon ablation in persistent atrial fibrillation : results from the multicenter CRYO4PERSISTENT AF trial
T2  - JACC Clinical electrophysiology
N2  - 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)
KW  - catheter ablation
KW  - cryoballoon
KW  - persistent atrial fibrillation
KW  - pulmonary vein isolation
Y1  - 2018
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/48473
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-484732
SN  - 2405-500X
SN  - 2405-5018
N1  - © 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/).
VL  - 4
IS  - 11
SP  - 1440
EP  - 1447
PB  - Elsevier
CY  - Amsterdam
ER  -