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

Abstract

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. K E Y W O R D S atrial fibrillation, catheter ablation, first in human, pulmonary vein isolation, radiofrequency, radiofrequency balloon 1260 | DHILLON ET AL.

Safety, effectiveness, and quality of life following pulmonary vein isolation with a multi-electrode radiofrequency balloon catheter in paroxysmal atrial fibrillation: 1-year outcomes from SHINE

“…The multi-electrode RF balloon catheter (RFB; HELIOSTAR, Biosense Webster, CA, USA) is a 28-mm spherical diameter, compliant balloon that is compatible with the three-dimensional electroanatomical mapping system (CARTO ® 3, Biosense Webster, CA, USA). 3 , 4 The RFB can perform circumferential or segmental ablation with 10 irrigated, flexible gold electrodes, each capable of independently delivering varying levels of RF energy to adjust for differences in target tissues ( Figure 1 ). The RADIANCE first-in-human study established the feasibility of the RFB to achieve electrical PVI with a favourable acute safety profile, without using a second focal catheter.…”

Anatomical targets and expected outcomes of catheter‐based ablation of atrial fibrillation in 2020

“…Its feasibility and safety profiles have been described in the RADIANCE study, in which PVI after a single delivery of RF energy was achieved in 79.6% of patients (39 paroxysmal AF patients). In the same series, freedom from documented atrial arrhythmia was 86.4% at 12 months of follow‐up 42 . Two other balloon ablation systems are also under evaluation, namely the POLARx cryoballoon (Boston Scientific, Marlborough, USA) and the Luminize RF hot balloon (Boston Scientific).…”

“…The use of other techniques and energy sources for PVI still require further investigation and should be considered with caution (Figure 3A). 8,42,54 In case of AF recurrences after a 3‐month blanking period, a redo procedure should evaluate PVs reconnections and lesion gaps and, in case of electrical reconnection of one or several PVs, repeat PVI and consider additional targets as in nonparoxysmal AF (Figure 3B). Further recurrences in paroxysmal AF may move the treatment into more complex scenarios like persistent AF.…”

Elektrophysiologie im Jahr 2020 – Ein Rückblick

“…Kürzere Ablationszeiten im linken Vorhof und Prozedurzeiten insgesamt sowie einfache Handhabung führten in den letzten Jahren zu einer immer weiteren Verbreitung von Single-Shot-Ablationsverfahren, v. a. des Kryoballons, für die Pulmonalvenenisolation [15]. [16].…”

“…Erste im Januar 2020 veröffentlichte Daten (RADIANCE-Studie [16]) zeigten neben dem vielversprechenden Potenzial dieser Technologie jedoch auch bekannte Probleme. So trat neben vereinzelten asymptomatischen Ösophaguserythemen bei 2,6 % der Patienten eine dauerhafte Parese des N. phrenicus während Ablation an den rechten Pulmonalvenen auf [16]. Hier werden in Zukunft weitere Daten zum Sicherheitsprofil, insbesondere im Hinblick auf Paresen des N. phrenicus benötigt.…”