Co-Author(s):
Stefania Riva, MD
Francesca Pizzamiglio, MD
Maria Antonietta Dessanai, MD
Valentina Ribatti, MD, PhD
Giulia Vettor, MD
Massimo Moltrasio, MD
Claudio Tondo, MD, FESC, FHRS
Centro Cardiologico Monzino IRCCS University of Milan
Via Parea 4 Milano
Introduction | Objectives: Pulmonary vein isolation (PVI) is the cornerstone of catheter-based
therapy for patients(Pts) with atrial fibrillation (AF). Single-shot
techniques were introduced to improve the procedure. A new
multi-electrode radiofrequency balloon catheter (RFB) provides PVI with
its 10 irrigated, flexible gold electrodes. The concurrent use of a
10-pole circular diagnostic catheter provides real-time PV recordings.
We analyzed time-dependent changes in procedural parameters, acute
success, complication rates during our initial experience in subjects
with drug refractory, symptomatic, paroxysmal AF.
Methods: 6 patients (age 63.5±6,8 yrs, 33.3% male) underwent PVI using the RFB
under conscious sedation. Esophageal temperature monitoring and phrenic
nerve pacing were performed in all patients. Based on animal Lab and
first human experiences, baseline impedance (90-110) and baseline
temperature (< 31C°) were set as indicators of optimal
electrode-tissue contact. Accordingly, contiguous lesion formation when
simultaneously ablating from adjacent electrodes were strongly
identified by impedance drop and temperature rise. Intracardiac
echocardiography confirmed optimal balloon positioning and stability
during RF delivery. Radiofrequency energy was delivered simultaneously
from all electrodes, up to 20 s posteriorly and 60 s anteriorly.
Results: 8.3±4.82 applications were delivered per patient; PVI was achieved in
100% of the 23 targeted PVs. An example of the balloon positioning both
on Carto system and on echo is shown in Figure 1. The balloon dwell time
was 37.5±24.5 min. The overall procedure time was 68.3±32.9 min, and the
fluoroscopy time was 12.3±5.2min. The first-pass isolation was achieved
in 79.6% of the assessed PVs; with additional RFB applications to the
remaining 5 PVs, all PVs were isolated. Mean time to isolation was
17.5+ 10.6 sec, obtained in all cases combining the recordings
from the decapolar catheter and the balloon electrodes. Acute
reconnection was provoked in only 2 PVs. No acute or delayed
complications occurred.
Conclusions: This preliminary experience demonstrated a remarkable acute safety
profile and effectiveness of the new RFB.
AFS 2021-48