Co-Author(s):
Pierre Jais, MD
Ante Anic, MD
Jan Petru, MD
Moritoshi Funasako, MD
Kentaro Minami, MD
Toni Breskovic, MD
Ivan Sikiric, MD
Lucie Sediva, MD
Milan Chovanec, MD
Petr Neuzil, MD PhD
Icahn School of Medicine at Mount Sinai
One Gustave L Levy Place Box 1030
Introduction | Objectives: Pulsed field ablation (PFA) is a non-thermal energy source notable for
its relative preferential effect on myocardial tissue, and not
surrounding tissues such as esophagus or phrenic nerve. However, PFA’s
efficacy/tissue selectivity is dependent on many factors – including
waveform characteristics. Thus, outcomes using one set of parameters
may not predict outcomes using different parameters. A multielectrode
pentaspline PFA system was optimized with prospective remapping
studies. Herein, we report the clinical outcomes – durability and
recurrent arrhythmias – using this optimized PFA waveform for treating
paroxysmal atrial fibrillation (PAF).
Methods: PAF pts underwent pulmonary vein isolation (PVI) with the pentaspline
catheter (Farawave; Farapulse Inc) and PFA generator using an optimized
PFA waveform (Optiwave; Farapulse Inc). By protocol, invasive remapping
was performed at ~3 mo; one-year follow-up included
weekly TTM and 6-/12-mo 24h Holters.
Results: At 3 sites, 5 operators performed PVI in 49 pts (57±10 y, 65% male,
40±5 mm LA diameter), with procedure duration 97.2±29.1 min (included
19.0±13.5 min of protocol-mandated mapping). All PVs (195 of 195 PVs)
were isolated, typically with the first ~3s application.
In all, there were 8.7±1.5 deliveries/PV. Primary safety events
included 2 vascular complications (one arising from a non-study device
during remap); there was no stroke, TIA, PV stenosis or phrenic nerve
injury. Additional safety assessments included screening EGD (11 pts)
and screening DW-MRI (5 pts) – all negative for esophagus and brain
injury, respectively. Remapping was performed in 44 pts (90%),
revealing durability in 166 of 173 (96%) PVs. At 337±63 days
follow-up, with 29 pts reaching study exit at 1 year, freedom from AF or
AF/AT/AFL were 85±6% and 85±5%, respectively.
Conclusions: Using an optimized waveform, the pentaspline PFA catheter achieved high
PVI durability, which in turn translated to excellent 1-year freedom
from recurrent atrial arrhythmia. This information is of particular
relevance, as this will be the available PFA waveform for both a
forthcoming randomized FDA clinical trial (ADVENT ), and for a
commercial system (expected in Europe in Q1-2021).
AFS2021-55
Uploaded File(s) One Year Outcomes Using an Optimized PFA
Waveform