TY - JOUR
T1 - Use of a multi-electrode radiofrequency balloon catheter to achieve pulmonary vein isolation in patients with paroxysmal atrial fibrillation: 12-Month outcomes of the RADIANCE study
AU - Dhillon, Gurpreet Singh
AU - Honarbakhsh, Shohreh
AU - Di Monaco, Antonio
AU - Coling, Ann Elizabeth
AU - Lenka, Kernerová
AU - Pizzamiglio, Francesca
AU - Hunter, Ross J.
AU - Horton, Rodney
AU - Mansour, Moussa
AU - Natale, Andrea
AU - Reddy, Vivek
AU - Grimaldi, Massimo
AU - Neuzil, Petr
AU - Tondo, Claudio
AU - Schilling, Richard J.
N1 - Funding Information:
This study received funds from Biosense Webster, Inc.
Publisher Copyright:
© 2020 Wiley Periodicals, Inc.
Copyright:
Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2020/6/1
Y1 - 2020/6/1
N2 - Background: The RADIANCE first-in-man study evaluated acute (3-month) safety and design concept in terms of utility of a new multi-electrode radiofrequency (RF) balloon catheter (HELIOSTAR, Biosense Webster) to achieve pulmonary vein isolation (PVI). After study conclusion, a subset of patients was followed up to 12 months. Methods: Patients with drug refractory paroxysmal atrial fibrillation were enrolled. Neurological assessment, cardiac and cerebral magnetic resonance imagings were performed pre and post procedure. Ablation was delivered at 15 Watts to each PV for 60 seconds (electrodes adjacent to the posterior wall limited to 20 seconds). Adenosine or isoproterenol was administered to confirm PVI. Esophageal endoscopy was performed 48 hours post procedure. Patients were clinically followed up for 12 months. Results: Thirty-nine patients underwent catheter ablation from four centers. Mean age was 60.7 ± 10.0 years with 23 (57.5%) being male. Confirmation of PVI was performed in all PVs treated (152/152). Confirmation of isolation after one delivery was performed solely on 137 of 152 PVs of which 79.6% (109/137) achieved isolation with a single delivery of RF energy. Acute PV reconnection was seen in 4.6% (7/150) of PVs. Freedom from documented atrial arrhythmia at 12 months in those followed up was 86.4% (32/37). A total of 75.7% (28/37) of patients were free from atrial arrhythmia and off antiarrhythmic medications. Conclusion: The HELIOSTAR RF balloon catheter allows for rapid and safe PVI with majority of PVs only requiring one application.
AB - Background: The RADIANCE first-in-man study evaluated acute (3-month) safety and design concept in terms of utility of a new multi-electrode radiofrequency (RF) balloon catheter (HELIOSTAR, Biosense Webster) to achieve pulmonary vein isolation (PVI). After study conclusion, a subset of patients was followed up to 12 months. Methods: Patients with drug refractory paroxysmal atrial fibrillation were enrolled. Neurological assessment, cardiac and cerebral magnetic resonance imagings were performed pre and post procedure. Ablation was delivered at 15 Watts to each PV for 60 seconds (electrodes adjacent to the posterior wall limited to 20 seconds). Adenosine or isoproterenol was administered to confirm PVI. Esophageal endoscopy was performed 48 hours post procedure. Patients were clinically followed up for 12 months. Results: Thirty-nine patients underwent catheter ablation from four centers. Mean age was 60.7 ± 10.0 years with 23 (57.5%) being male. Confirmation of PVI was performed in all PVs treated (152/152). Confirmation of isolation after one delivery was performed solely on 137 of 152 PVs of which 79.6% (109/137) achieved isolation with a single delivery of RF energy. Acute PV reconnection was seen in 4.6% (7/150) of PVs. Freedom from documented atrial arrhythmia at 12 months in those followed up was 86.4% (32/37). A total of 75.7% (28/37) of patients were free from atrial arrhythmia and off antiarrhythmic medications. Conclusion: The HELIOSTAR RF balloon catheter allows for rapid and safe PVI with majority of PVs only requiring one application.
KW - atrial fibrillation
KW - catheter ablation
KW - first in human
KW - pulmonary vein isolation
KW - radiofrequency
KW - radiofrequency balloon
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U2 - 10.1111/jce.14476
DO - 10.1111/jce.14476
M3 - Article
C2 - 32250514
AN - SCOPUS:85084083794
VL - 31
SP - 1259
EP - 1269
JO - Journal of Cardiovascular Electrophysiology
JF - Journal of Cardiovascular Electrophysiology
SN - 1045-3873
IS - 6
ER -